16/08/2024 9:15pm
Edgar (US Regulatory)
PRELIMINARYOFFERING CIRCULAR DATED AUGUST 16, 2024 ANOFFERING STATEMENT PURSUANT TO REGULATION A RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.INFORMATION CONTAINED IN THIS PRELIMINARY OFFERING CIRCULAR IS SUBJECT TO COMPLETION OR AMENDMENT. THESE SECURITIES MAY NOT BE SOLD NORMAY OFFERS TO BUY BE ACCEPTED BEFORE THE OFFERING STATEMENT FILED WITH THE COMMISSION IS QUALIFIED. THIS PRELIMINARY OFFERING CIRCULARSHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR MAY THERE BE ANY SALES OF THESE SECURITIES IN ANY STATEIN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL BEFORE REGISTRATION OR QUALIFICATION UNDER THE LAWS OF ANY SUCH STATE. WEMAY ELECT TO SATISFY OUR OBLIGATION TO DELIVER A FINAL OFFERING CIRCULAR BY SENDING YOU A NOTICE WITHIN TWO BUSINESS DAYS AFTER THE COMPLETIONOF OUR SALE TO YOU THAT CONTAINS THE URL WHERE THE FINAL OFFERING CIRCULAR OR THE OFFERING STATEMENT IN WHICH SUCH FINAL OFFERING CIRCULARWAS FILED MAY BE OBTAINED. OFFERING CIRCULAR By this offering circular (the “OfferingCircular”), Tivic Health Systems, Inc., a Delaware corporation, is offering on a “best-efforts” basis a maximum of 6,666,667shares of its common stock (assuming the maximum offering price in the range), par value $0.0001 per share (the “Offered Shares”),at a fixed price between $1.00 to $3.00 per share (to be fixed by post-qualification supplement), pursuant to Tier 2 of Regulation A ofthe United States Securities and Exchange Commission (the “SEC”). There is no minimum purchase requirement for investors inthis offering. We are also offering to thosepurchasers, if any, whose purchase of Offered Shares in this offering would otherwise result in such purchaser, together with its affiliatesand certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding sharesof common stock immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses,pre-funded warrants (“Pre-Funded Warrants”) in lieu of the Offered Shares that would otherwise result in such purchaser’sbeneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock. The purchaseprice of each Pre-Funded Warrant will be equal to the public offering price per Offered Shares sold in this offering minus $0.001, theexercise price per share of common stock of each Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable and may be exercisedat any time until all of the Pre-Funded Warrants are exercised in full. For each Pre-Funded Warrantwe sell, the number of Offered Shares we are offering will be decreased on a one-for-one basis. The shares of common stock issuable fromtime to time upon exercise of the Pre-Funded Warrants are also being offered by this Offering Circular. This offering is being conductedon a “best-efforts” basis, which means that there is no minimum number of Offered Shares that must be sold by us for thisoffering to close; thus, we may receive no or minimal proceeds from this offering. None of the proceeds received will be placed in anescrow or trust account. All proceeds from this offering will become immediately available to us and may be used as they are accepted.Purchasers of the Offered Shares will not be entitled to a refund and could lose their entire investments. Please see the “Risk Factors” section, beginning on page 12, for a discussion of the risks associated with a purchase of the Offered Shares (or Pre-FundedWarrants in lieu thereof). We estimate that this offeringwill commence within two days of SEC qualification; this offering will terminate at the earliest of (a)the date on which the maximumoffering has been sold, (b)one year from the date of SEC qualification, or (c)the date on which this offering is earlier terminatedby us, in our sole discretion. (See “Plan of Distribution”). Number of Shares Price to Public(1) Our common stock is listed on The Nasdaq Capital Market(“Nasdaq”), under the symbol “TIVC.” On August 12, 2024, the last reported sale price of our common stock was$0.38 per share. Investing in the OfferedShares (or Pre-Funded Warrants in lieu thereof) is speculative and involves substantial risks. You should purchase Offered Shares (orPre-Funded Warrants in lieu thereof) only if you can afford a complete loss of your investment. See “Risk Factors”, beginningon page 12, for a discussion of certain risks that you should consider before purchasing any of the Offered Shares (or Pre-Funded Warrantsin lieu thereof). THE UNITED STATES SECURITIESAND EXCHANGE COMMISSION DOES NOT PASS UPON THE MERITS OF, OR GIVE ITS APPROVAL TO, ANY SECURITIES OFFERED OR THE TERMS OF THE OFFERING,NOR DOES IT PASS UPON THE ACCURACY OR COMPLETENESS OF ANY OFFERING CIRCULAR OR OTHER SOLICITATION MATERIALS. THESE SECURITIES ARE OFFEREDPURSUANT TO AN EXEMPTION FROM REGISTRATION WITH THE SEC; HOWEVER, THE SEC HAS NOT MADE AN INDEPENDENT DETERMINATION THAT THE SECURITIESOFFERED ARE EXEMPT FROM REGISTRATION. The use of projectionsor forecasts in this offering is prohibited. No person is permitted to make any oral or written predictions about the benefits you willreceive from an investment in Offered Shares (or Pre-Funded Warrants in lieu thereof). No sale may be made toyou in this offering, if you do not satisfy the investor suitability standards described in this Offering Circular under “Plan of Distribution—State Law Exemption and Offerings” to “Qualified Purchasers” on page 39. Before making any representationthat you satisfy the established investor suitability standards, we encourage you to review Rule 251(d)(2)(i)(C) of Regulation A. Forgeneral information on investing, we encourage you to refer to www.investor.gov. This Offering Circular followsthe disclosure format of Form S-1, pursuant to the General Instructions of Part II(a)(1)(ii) of Form 1-A. The date of this OfferingCircular is _______________, 2024. TABLE OF CONTENTS Page CAUTIONARY STATEMENT REGARDING FORWARD-LOOKINGSTATEMENTS The information contained in this OfferingCircular includes some statements that are not historical and that are considered “forward-looking” statements, as such termis defined by the SEC in its rules, regulations and releases, which represent our expectations or beliefs, including but not limited to,statements concerning our operations, economic performance, financial condition, growth and acquisition strategies, investments, and futureoperational plans. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-lookingstatements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,”“believe,” “anticipate,” “intent,” “could,” “estimate,” “might,”“plan,” “predict” or “continue” or the negative or other variations thereof or comparable terminologyare intended to identify forward-looking statements. These statements, by their nature, involve substantial risks and uncertainties, certainof which are beyond our control, and actual results may differ materially depending on a variety of important factors, including uncertaintyrelated to acquisitions, governmental regulation, managing and maintaining growth, the operations of the Company and its subsidiaries,volatility of stock price, commercial viability of our product candidates and any other factors discussed in this and other registrantfilings with the SEC. These risks and uncertainties and otherfactors include, but are not limited to those set forth under “Risk Factors” of this Offering Circular. Given these risksand uncertainties, readers are cautioned not to place undue reliance on our forward-looking statements. All subsequent written and oralforward-looking statements attributable to us or to persons acting on our behalf are expressly qualified in their entirety by these cautionarystatements. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward- lookingstatements or the risk factors described in this Offering Circular, whether as a result of new information, future events, changed circumstancesor any other reason after the date of this Offering Circular. This Offering Circular contains forward-lookingstatements, including statements regarding, among other things: Actual events or results may differ materiallyfrom those discussed in forward-looking statements as a result of various factors, including, without limitation, the risks outlined underthe section of this Offering Circular entitled “Risk Factors” and matters described generally. In light of these risks anduncertainties, there can be no assurance that the forward-looking statements contained in this Offering Circular will in fact occur. Wecaution you not to place undue reliance on these forward-looking statements. In addition to the information expressly required to be includedin this Offering Circular, we will provide such further material information, if any, as may be necessary to make the required statements,in light of the circumstances under which they are made, not misleading. The following summary highlights informationcontained elsewhere in this Offering Circular and does not contain all of the information that you should consider in making your investmentdecision in our securities. Before investing in our securities, you should carefully read this entire Offering Circular, including ourfinancial statements and the related notes included in this Offering Circular and the information set forth under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” As usedin this Offering Circular, unless the context otherwise requires, references to “we,” “us,” “our,”“Company,” and “Tivic Health” refer to Tivic Health Systems, Inc. Business Overview Tivic Health is a health tech companyfocused on bioelectronic medicine. Bioelectronic medicine is a branch of the global neuromodulation market that treats disease and conditionsby modulating the electrical signals carried along various nerve pathways. The field grew out of the neuromodulation industry and relied,historically, on implantable devices (e.g., pacemakers, spinal implants, deep brain stimulators). IDTechEx has identified several fast-growingareas in the bioelectronic medicine field, including peripheral nerve stimulation, which it has indicated is forecasted to grow at a 35%CAGR from 2019 through 2029. Tivic currently has two non-invasive bioelectronic platforms designed to deliver therapeutic benefits viamanipulation of such signals without the use of traditional implanted technology. Platforms Tivic has developed two complementaryplatforms. Tivic’s first commercial platform is a handheld design that interfaces non-invasively with the trigeminal, sympathetic,and other facial and cranial nerve structures. This platform is the basis for Tivic’s existing product, currently marketed withFDA approval as ClearUP Sinus Pain Relief for the treatment of sinus pain and congestion. The second platform is a research-stageplatform directed to vagus nerve stimulation, which is currently undergoing clinical evaluation. We received the final data analysis forour pilot clinical study with The Feinstein Institutes for Medical Research in the beginning of May 2024, and the final data analysisresults were publicly announced by the Company on May 8, 2024. See the section of this Offering Circular entitled “Recent Developments”for additional information regarding the final data results. First Commercial Product Tivic Health currently markets onecommercial product under the brand name “ClearUP Sinus Pain Relief.” ClearUP is built on our patented, handheld neuromodulationdesign and was developed by Tivic Health for the treatment of sinus and allergy-related conditions. It uses ultra-low current electricalwaves to relieve sinus pain and congestion symptoms that are prevalent in nasal allergies, sinus infections, chronic sinusitus, cold andflu and other disease conditions. ClearUP had U.S. FDA approval for the treatment of sinus pain and congestion, and is the first FDA-approvedbioelectronic treatment of the foregoing indications. Additionally, ClearUP has E.U. CE Mark approval for the treatment of sinus pain,pressure and congestion. The FDA initiallyprovided clearance to our ClearUP product under a 510(k) as an allergy treatment in January 2019. The FDA granted ClearUP asubsequent De Novo clearance in March 2021, which expanded ClearUP’s label, enabling marketing of ClearUP for allergies,sinusitis, cold, flu, and any inflammatory condition involving congestion. A 2023 study with over 2,000 representativeconsumers conducted by Intellego Insights (commissioned by Tivic Health) identified that approximately 85 million U.S. adults experienceinflammation-related symptoms related to allergies, congestion, head pain, and sinus issues. Of the consumers that participated in thestudy, 58% of sufferers try to avoid medication, if at all possible. Customers can purchase ClearUP productsdirectly from Tivic via our own website and through major online stores, including Amazon, Walmart, BestBuy, FSAStore and HSA Store. TheCompany has also entered distribution agreements with McKesson, Cardinal Health and Amerisource Bergen. A sham-controlled clinical trial is inprogress with the Icahn School of Medicine at Mount Sinai, to extend the use of Tivic’s handheld monopolar platform to the managementof pain resulting from functional endoscopic sinus surgery and other facial surgeries. If successful, the Company may develop additionalproducts addressing this clinical use case, which would require new regulatory clearances for a novel indication. We have also previously evaluated themarket opportunity for use of ClearUP as part of a migraine treatment toolkit. While we believe that both clinical and market rationaleare positive for such use, we have, for the time being, determined to down-prioritize any clinical studies of migraine-related indicationsbased on the aggressive competition among entrenched incumbents and limited uptake, to date, of existing devices for the treatment and/or prevention of migraine. Expanding Our Technology Portfolio Tivic has also developed a proprietarynon-invasive approach to precision vagus nerve stimulation (“VNS”) based on our experience building evidence-based bioelectronictherapies. The vagus nerve is the tenth cranial nerve and the longest autonomic nerve in the body. The vagus nerve is responsible forregulating several bodily functions including digestion, heart rate, breathing, cardiovascular activity, and visceral reflexes. Sincethe vagus nerve regulates many organ systems associated with chronic disease, modulating activity in this nerve pathway is of significantinterest in academic research and in industry. Electrical VNS is currently indicatedfor treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation and is being studied forother neurological, cardiac, and immune conditions. Currently, there are both invasive implantable VNS devices and non-invasive VNS devicesin market. There is room for meaningful improvement in how VNS devices can be used to more precisely target and stimulate the vagus nerveto achieve intended biological and clinical outcomes. Our approach to non-invasive VNS aimsto leverage improvements in engineering, circuitry, and stimulation parameters to augment efficacy and reliability compared to the currentstate of the art. We have conducted proof of principle experiments demonstrating effects on the autonomic nervous system and have initiateda clinical research program with The Feinstein Institute for the Bioelectronic Medicine at Northwell Health to further characterize theautonomic, cardiovascular, and neurological effects of our intervention. On May 8, 2024, we publicly announced the final data analysisresults for our VNS pilot study conducted as part of this program, which results are discussed in further detail in the section of thisOffering Circular entitled “Recent Developments” for additional information regarding the final data results. Given our deep expertise and relationshipsin the field of bioelectronic medicine and adjacent diagnostic fields, we are continuously monitoring and evaluating options to add complementaryproduct opportunities into our product portfolio. Market Opportunity and RegulatoryClearances The FDA provided clearance to our ClearUPproduct under a 510(k) for the temporary relief of sinus pain associated with allergic rhinitis in January 2019. As a treatment for allergy-relatedsinus pain, we believe that the available market for ClearUP is approximately 45 million U.S. adults. The FDA then granted ClearUP a subsequentDe Novo clearance in March 2021 for the temporary relief of moderate to severe congestion, expanding ClearUP’s label and enablingmarketing of ClearUP for allergies, sinusitis, cold, flu, and any inflammatory condition involving congestion. As a treatment for moderateto severe congestion, we believe the available target market for ClearUP is approximately 85 million U.S. adults. Additionally, we have received a CEMark for international marketing of ClearUP. The CE Mark for ClearUP covers a broad set of conditions related to sinonasal inflammationwith the symptoms pain, pressure and congestion. The CE Mark allows sales in European Union Member states and certain other countriesthat recognize the CE Mark for regulatory governance. We believe that there are international opportunities for the sale of ClearUP. Competition Sinus pain, pressure and congestion aretypically managed with over-the-counter pharmaceuticals and saline irrigation of the sinus and nasal cavities. Analgesic medications (e.g.,ibuprofen/Advil, acetaminophen/Tylenol, naproxen sodium/Aleve) are often used to treat sinus pain/pressure. Congestion is often managedwith antihistamines (e.g., loratadine/Claritin), oral decongestants (e.g., phenylephrine/Sudafed) and intranasal decongestants (e.g.,oxymetazoline/Afrin), and intranasal glucocorticoids (e.g., fluticasone propionate/Flonase). Over the counter pharmaceuticals havehistorically had the greatest market share for sinus pain and congestion treatments; however, according to Mintel Group Ltd.’s 2020report on Cough, Cold, Flu, and Allergy Remedies, there is increasing interest among consumers to reduce reliance on drugs and to findnon-drug solutions. Non-drug competitors for sinus pain and congestion treatment include nasal irrigation products such as Sinus Rinseand Navage Nasal Care. We believe that other companies selling non-pharmaceutical treatments, specifically nasal irrigation products,represent our closest competitors. ClearUP is an emerging new product offering, and currently has a small market share. Barriers to Entry As a commercial-stage company that hasinvested our energy into patent protection and regulatory clearances, we believe we have built competitive advantages that include: Government Regulation Our products are subject to extensiveand rigorous regulation by the FDA and other federal, state and local authorities, as well as foreign regulatory authorities. The FDAregulates, among other things, the research, development, testing, design, manufacturing, approval, labeling, storage, recordkeeping,advertising, promotion and marketing, distribution, post approval monitoring and reporting and import and export of medical devices inthe United States to assure the safety and effectiveness of medical devices for their intended use. The Federal Trade Commission (“FTC”)also regulates the advertising and labeling of our device in the United States. Further, we are subject to laws directed at preventingfraud and abuse, which subject our sales and marketing, training and other practices to government scrutiny. Risks Associated with our Business An investment in our securities involvesa high degree of risk. You should carefully consider the risks summarized below. These risks are discussed more fully in the section entitled“Risk Factors” following this Offering Circular summary. These risks include, but are not limited to, the following: Operational Updates In 2023, we invested in our marketing, product design, distributionrelationships, and quality systems as follows: In 2023, we also invested in our product innovation and developmentprograms as follows: As a result of these programs, the Companywas named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2023 in the Medical Devicecategory. Additionally, in 2022, Global Health & Pharma named Tivic Health the Most Pioneering Bioelectronic Medicine Company of 2022. In the first half of 2024: VNS Pilot Clinical Study Results On May 8, 2024, we issued a press release announcingthe final data analysis for our VNS pilot clinical study. We conducted the pilot study in collaboration with the Zanos Laboratory at TheFeinstein Institutes for Medical Research to determine how our non-invasive cervical VNS (“ncVNS”) intervention affects theautonomic nervous system (“ANS”), cardiac, and brain function. Twenty healthy subjects were recruited and treated with ncVNSfor twenty minutes and several physiologic measurements were taken before, during and after the treatment protocol. Study subjects exhibiteda sustained reduction in pupil diameter during ncVNS, which is consistent with increased vagal tone and parasympathetic activation. ANSactivity was also measured via electrocardiogram and root mean square of successive differences (“RMSSD”), a widely used measureof heart rate variability that is used as a proxy for vagus nerve activity. Compared with before ncVNS, after treatment subjects had a97% increase in RMSSD, which is indicative of an increased parasympathetic state. The cardiac data suggest potential applications in arrythmiasand cardiovascular disease. Lastly, electroencephalography was applied before and after ncVNS to measure brain activity. Subjects hada mean 24% increase in frontal theta activity, which is indicative of calm awake states, and a > 60% reduction in gamma activity inseveral brain regions, including the temporal lobe. The magnitude of the changes seen in our ncVNS study suggest our ncVNS approach mayhave clinical utility in several patient populations including those with epilepsy, depression, post-traumatic stress disorder and ischemicstroke, among others. Based on these promising data results, we believethat there may be significant potential for our platform in the noninvasive VNS space. We are working with The Feinstein Institutes forMedical Research to carry out the next phase of research for our clinical program, an optimization study to further refine the treatmentparameters to address discrete disease targets. Additional clinical studies will be required to secure regulatory clearance and TivicHealth’s VNS approach is currently for investigational use only. On May 17, 2024, we entered into a Collaboration andResearch Support Agreement with The Feinstein Institutes for Medical Research, pursuant to which we will collaborate with The FeinsteinInstitutes for Medical Research in the development and drafting of a protocol (the “Protocol”) to advance a research programdesigned to test Autonomic Nervous System (“ANS”) function and/or balance in healthy able-bodied individuals in response toneuromodulation of the ANS by our neurostimulation device, by leveraging and augmenting the NDS Lab’s multi-modal index to quantifythe activation status of the ANS during various of clinically relevant tests, and to submit such Protocol and the research study describedtherein (the “Study”) for institutional and IRB approval. If the Protocol and Study are approved, the Study shall be implementedpursuant to the Protocol and shall be governed by the terms of the agreement. Total length of the project is expected to be one year. Pursuant to the agreement, we shall be responsiblefor participant reimbursement and the full time equivalents involved in acquiring IRB approval, recruiting and performing the experiments,and analyzing all the data and development of all algorithms, as more particularly set forth in the Agreement. Payments will be made bythe Company upon completion of the following milestones: ALOM Agreement Termination Effective August 1, 2024, we terminated theFulfillment Services Agreement with ALOM Technologies Corporation (“ALOM”) on November 25, 2022, as amended on March 5, 2024(the “ALOM Agreement”), pursuant to which ALOM provided, on a non-exclusive basis, certain assembly, procurement, storage, returns,and fulfillment services (collectively, the “Services”) to our end customers and retailers within the United States. Weterminated the ALOM Agreement for convenience, in accordance with the terms of the ALOM Agreement, in furtherance of our efforts to continueto reduce both direct and indirect costs associated with product manufacturing and distribution. We did not incur any material early terminationpenalties in connection with the termination of the ALOM Agreement. We are now utilizing third-party logistics and storage services fromalternate suppliers without material minimums and have established in-house assembly and testing capabilities. We completed the transitionwith no disruptions to service and foresees current capacity will be sufficient to meet demand for the foreseeable future. Nasdaq Deficiency On June 28,2024, we received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”)notifying us that, because the closing bid price for our common stock was below $1.00 per share for 33 consecutive business days, we arenot currently in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth inNasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The notification had no immediate effect on thelisting of our common stock on the Nasdaq Capital Market, and, therefore, our listing remains fully effective. In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A),we have a period of 180 calendar days from June 27, 2024, or until December 26, 2024, to regain compliance with the Minimum Bid PriceRequirement. If at any time before December 26, 2024, the closing bid price of our common stock closes at or above $1.00 per share fora minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the MinimumBid Price Requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending on December26, 2024, then Nasdaq may grant us a second 180 calendar day grace period to regain compliance, provided we (i) meet the continued listingrequirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market, other thanthe minimum closing bid price requirement, and (ii) we notify Nasdaq of our intent to cure the deficiency. We intend to continue actively monitoring the closing bid price for ourcommon stock between now and December 26, 2024, and will consider available options to resolve the deficiency and regain compliance withthe Minimum Bid Price Requirement. If we do not regain compliance within the allotted compliance period, including any extensions thatmay be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting. We would then be entitled toappeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance with the Minimum Bid PriceRequirement during the 180 day compliance period, secure a second period of 180 calendar days to regain compliance, or maintain compliancewith the other Nasdaq listing requirements. Corporate Information The Company was incorporated inCalifornia in September 2016 and reincorporated as a Delaware corporation in June 2021. Our principal executive offices are locatedat 47685 Lakeview Blvd., Fremont, California 94538. Our telephone number is (888) 276-6888 and our corporate website iswww.tivichealth.com. Unless expressly noted, none of the information on our corporate website is part of this Offering Circular orany amendment to Offering Circular. Where You Can Find More Information For additional information regarding ourbusiness, properties and financial condition, please refer to the documents cited in the section of this Offering Circular entitled “Where You Can Find More Information.” The Offered Shares, 6,666,667 shares of common stock (assuming themaximum offering price in the range of $3.00), are being offered by the Company in a “best-efforts” offering. We are also offering to those purchasers, if any, whose purchase of common stock in this offering would otherwise result in such purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses, Pre-Funded Warrants in lieu of shares common stock that would otherwise result in such purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock. This offering also relates to the shares of common stock issuable upon exercise of any Pre-Funded Warrant sold in this offering. For each Pre-Funded Warrant that we sell, the number of shares of common stock that we are offering will be decreased on a one-for-one basis. The purchase price of each Pre-Funded Warrant will be equal to the public offering price per share of common stock sold in this offering minus $0.001, the exercise price per share of common stock of each Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. To better understand the terms of the Pre-Funded Warrants, you should carefully read the section of this Offering Circular entitled “Description of Securities We are Offering.” You should also read the form of Pre-Funded Warrant, which is filed as an exhibit to this Offering Circular. 12,850,259 shares of common stock issued and outstanding, assuming all of the Offered Shares are sold hereunder and assuming no sales of Pre-Funded Warrants which, if sold, would reduce the number of shares of common stock that we are offering on a one-for-one basis. Minimum Number of Shares to Be Sold in This Offering (1) The number of shares to be outstandingafter this offering is based on 6,183,592 shares outstanding as of August 12, 2024 and excludes: Continuing Reporting Requirements UnderRegulation A We are required to fileperiodic and other reports with the SEC, pursuant to the requirements of Section 13(a) of the Exchange Act. Our continuing reporting obligationsunder Regulation A are deemed to be satisfied as long as we comply with our Section 13(a) reporting requirements. An investment in theOffered Shares (or Pre-Funded Warrants in lieu thereof) involves substantial risks. You should carefully consider the following risk factors,in addition to the other information contained in this Offering Circular, before purchasing any of the Offered Shares (or Pre-Funded Warrantsin lieu thereof). The occurrence of any of the following risks might cause you to lose a significant part of your investment. The risksand uncertainties discussed below are not the only ones we face, but do represent those risks and uncertainties that we believe are mostsignificant to our business, operating results, prospects and financial condition. Some statements in this Offering Circular, includingstatements in the following risk factors, constitute forward-looking statements. See “Cautionary Statement Regarding Forward-Looking Statements”. Risk Factor Summary Below is a summary of the principalfactors that make an investment in our securities speculative or risky. This summary does not address all of the risks that we face. Additionaldiscussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below and should be carefullyconsidered, together with other information included in this Offering Circular. If our stock price continues to remain below $1.00, our common stockmay be subject to delisting from The Nasdaq Capital Market, which would materially reduce the liquidity of our common stock and have anadverse effect on our market price. Risks Related to Our Financial Conditionand Business Model We have a relatively limited operatinghistory and may not be able to execute on our business strategy. We were originally incorporated in 2016and began selling our first product in 2019. Accordingly, we have a limited operating history, which makes an evaluation of our futureprospects and execution ability difficult. Our revenue and income-producing potential is unproven, and our business model and strategymay continue to evolve. Future revenues are contingent upon several factors, including, without limitation, our ability to successfullydevelop and scale-up sales of the ClearUP line and future products, our ability to develop relationships with channel partners and customers,as well as the clinical and market acceptance of our technology. We may need to make business decisions that could adversely affect ouroperating results, such as modifications to our pricing strategy, business structure or operations. Our operating results will likelybe volatile and may not be a reliable indicator of our future performance. Our future expenses, revenues and operatingresults may vary significantly from quarter to quarter due to a number of factors, including, without limitation: We expect that our revenues may be volatileas we develop new technology and obtain new customers in the future. The volume and timing of commercial outcomes are difficult to estimate,as the adoption of bioelectronic treatments is immature, and the sales cycle may vary substantially from forecasts. If we fail to manage our growtheffectively, our business could be materially and adversely affected. We will not besuccessful unless we are able to generate additional revenues and grow our business, which will likely require us to hire additionalemployees and expand our technology, product, development and sales and marketing teams in order to achieve our business plan. Ourmanagement systems are emergent. The continued growth of our business may place demands on our management, financial, operational,technological and other resources, and we expect that our growth will require us to continue developing and improving ouroperational, financial and other internal controls. We may not be able to address these challenges in a cost-effective manner, or atall. If we do not effectively manage our growth, we may not be able to execute on our business plan, respond to competitivepressures, take advantage of market opportunities, satisfy customer requirements or maintain high-quality product offerings, whichcould have a material adverse effect on our business, financial condition and results of operations. We have a history of net lossesand we may not achieve or maintain profitability in the future. We have incurred netlosses since inception. For the years ended December 31, 2023 and 2022, we incurred net losses of $8.2 million and $10.1 million,respectively, and at December 31, 2023, we had working capital of $3.3 million and an accumulated deficit of $37.9 million. Duringthe years ended December 31, 2023 and 2022, we used $8.5 million and $8.9 million of cash, respectively, for operating activities.For the six months ended June 30, 2024, we incurred a net loss of $2.7 million, and at June 30, 2024, we had cash and cashequivalents of $3.7 million, an accumulated deficit of $40.6 million, and working capital of $4.1 million. The net losses we incur may fluctuatesignificantly from quarter to quarter and may increase as a result of macroeconomic factors. Additionally, future costs relating to productdevelopment and operating activities may be significantly higher than our historical costs. Management expects to incur substantialadditional operating losses for the foreseeable future to expand our markets, complete development of new products, obtain regulatoryapprovals, launch and commercialize our products and continue research and development programs. Our future capital requirements willdepend upon many factors, including, without limitation, progress with developing, manufacturing and marketing our technologies; the timeand costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights; our abilityto successfully execute our acquisition strategy, including the closing of potential acquisitions and integrating new business into ourown; our ability to establish collaborative arrangements; marketing activities; and competing technological and market developments. Ourability to generate revenue and achieve profitability requires us to successfully market and secure purchase orders for our products andservices from customers currently identified in our sales pipeline as well as new customers. We will also be required to efficiently manufactureand deliver equipment on those purchase orders. These activities, including our planned research and development efforts, will requiresignificant uses of working capital. There can be no assurance that we will generate revenue and cash as expected in our current businessplan. We expect that we will need to raise additional capital to continue operating our business and fund our planned operations, includingto execute on our acquisition strategy, research and development, clinical trials and, if regulatory approval is obtained, commercializationof future product candidates. We may seek additional funds through equity or debt offerings and/or borrowings under notes payable, linesof credit or other sources. We do not know whether additional financing will be available on commercially acceptable terms, or at all,when needed. If adequate funds are not available or are not available on commercially acceptable terms, our ability to fund our operations,support the growth of our business or otherwise respond to competitive pressures could be significantly delayed or limited, which couldmaterially and adversely affect our business, financial conditions, or results of operations. Our long-term success is dependent uponour ability to successfully develop, commercialize and market our products, earn revenue, obtain additional capital when needed and, ultimately,to achieve profitable operations. We will need to generate significant additional revenue to achieve profitability. Future products mayrequire substantially higher levels of investment than initial products, including investments in research, development, regulatory and/ormarketing and sales. It is possible that we will not achieve profitability or that, even if we do achieve profitability, we may not maintainor increase profitability in the future. Our failure to achieve or maintain profitability could negatively impact the value of our commonstock. There is substantial doubt aboutour ability to continue as a going concern. Because we have incurred operating lossessince inception, and based on our current cash levels and burn rate, amongst other things, we believe our cash and financial resourcesmay be insufficient to meet our anticipated needs for the next twelve months, which raises substantial doubt about our ability to continueas a going concern within one year from the issuance date of the financial statements included elsewhere in this Offering Circular. Theselosses are expected to continue for at least a period of time. As a result, our independent registered public accounting firm includedan explanatory paragraph in its report on our financial statements for the fiscal years ended, December 31, 2023 and 2022, describingthe existence of substantial doubt about our ability to continue as a going concern. The financial statements included elsewhere in thisOffering Circular have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilitiesin the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classificationof asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern withinone year after the date the financial statements are issued. In the event that we raise the maximumamount of cash proceeds in this offering, and assuming that our operations do not materially change, we currently expect that we wouldhave sufficient cash to fund our operating expenses and capital expenditure requirements for twelve months after closing. However, inthe event that we do not raise the maximum amount of cash proceeds in this offering, we may require additional funding to continue asa going concern for the next twelve months. Our ability to obtain additional financing,if and when needed, will depend on a number of factors, including, among others, the condition of the capital markets and the other risksdescribed in these risk factors. If any one of these factors is unfavorable, we may not be able to obtain additional funding, in whichcase, our business could be jeopardized and we may not be able to continue our operations or pursue our strategic plans. If we are forcedto scale down, limit or cease operations, our shareholders could lose all or part of their investment in our Company. We have identified a materialweakness in our internal control over financial reporting. In connection with theaudit of our financial statements for the years ended December 31, 2023 and 2022, we identified a material weakness in our internalcontrol over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control overfinancial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financialstatements will not be prevented or detected on a timely basis. In 2022, we remediated deficiencies related to inventory costaccounting procedures, and to the extent possible, the segregation of duties. In addition, we completed our internal control designand formalized various internal control processes and procedures during the year ended December 31, 2022. However, due to the smallsize of our accounting and financial reporting team, as well as recent staff turnover even with processes and procedures in place tomitigate the risk of a material misstatement, we believe that there is still a reasonable possibility that a material misstatementof our annual or interim financial statements may not be prevented or detected on a timely basis. If we are unable to remedy ourmaterial weakness, or if we generally fail to establish and maintain effective internal controls appropriate for a public company,we may be unable to produce timely and accurate financial statements, and we may continue to conclude that our internal control overfinancial reporting is not effective, which could adversely impact our investors’ confidence and our stock price. We expect that we will need additionalcapital, which, if obtainable, could dilute the ownership interest of investors. We anticipate we will need additionalcapital to market our products, develop additional products and fund our operations, which we may raise through the sale and issuanceof equity, equity-related or convertible debt, or other securities. Our future capital requirements depend on many factors including ourneed to market our products, acquire or develop additional products and fund our operations. We cannot be certain that additional financingwill be available to us on acceptable terms when required, or at all. If we issue additional equity securitiesor securities convertible into equity securities, our existing stockholders will be subject to dilution. Additionally, sales of substantialamounts of our equity securities could have an adverse effect on the value of our equity and our ability to raise additional capital throughfuture capital increases. Our business plan depends heavilyon revenues from our initial products, the clinical and consumer acceptance of which is unproven at this time. Our future growth depends on the commercialsuccess of our technology and initial products. It is not certain that our target customers will choose our technology for technical,cost, support or commercial reasons. If our target customers do not widely adopt and purchase our technology, our future growth will belimited. Further, our resources and investments may not be adequate to achieve the targeted level of manufacturing and sales set out inour business plan. Cybersecurity risks and cyber incidents,as well as other significant disruptions of our information technology networks and related systems and resources, could adversely affectour business, disrupt operations and expose us to liabilities to employees, customers, governmental regulators, and other third parties. We use information technology and othercomputer resources to carry out important operational activities and to maintain our business records. As part of our normal businessactivities, we permit certain employees to perform some or all of their business activities remotely, we collect and store certain personalidentifying and/or confidential information relating to our employees, customers, vendors and suppliers, and we maintain operational andfinancial information related to our business. Furthermore, we rely on products and services provided by third-party suppliers to operatecertain critical business systems, including without limitation, cloud- based infrastructure, encryption and authentication technology,email, and other functions, which exposes us to supply-chain attacks or other business disruptions. We face risks associated with securitybreaches through cyber-attacks or cyber-intrusions, malware, computer viruses and malicious codes, ransomware, attachments to e-mail,unauthorized access attempts, denial of service attacks, phishing, social engineering, persons with access to systems inside our organization,and other significant disruptions of our information technology networks and related systems. The risk of a security breach has generallyincreased as the frequency, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Eventhe most well protected information, networks, systems and facilities remain potentially vulnerable because the techniques, tools andtactics used in such attempted security breaches evolve and generally are not recognized until launched against a target, and in somecases are designed to not be detected and, in fact, may not be detected. Accordingly, we may be unable to anticipate these techniquesor to implement adequate security barriers, disaster recovery or other preventative or corrective measures, and thus it is impossiblefor us to entirely counteract this risk or fully mitigate the harms after such an attack. We have implemented certain systems andprocesses intended to address ongoing and evolving cybersecurity risks, secure our information technology, applications and computer systems,and prevent unauthorized access to or loss of sensitive, confidential and personal data. Although we and our service providers employwhat we believe are adequate security, disaster recovery and other preventative and corrective measures, our security measures, takenas a whole, may not be sufficient for all possible situations and may be vulnerable to, among other things, fraud, hacking, employee error,system error, and faulty password management. Additionally, we rely on third-parties for virtually all of our operating infrastructure,who may themselves have standards of materiality of cybersecurity risks that differ from the materiality standards of Tivic itself. Our ability to conduct our business maybe impaired if our or our services providers’ information technology networks, systems or resources, including our and their websitesor e-mail systems, are compromised, degraded, damaged or fail, whether due to a virus or other harmful circumstance, fraud, intentionalpenetration or disruption of our or their information technology resources by: A significant and extended disruptioncould damage our business or reputation and cause, amongst other things, loss of revenues or customer relationships, unintended and/orunauthorized public disclosure or the misappropriation of proprietary, personal identifying and confidential information, and us to incursignificant expenses to address and remediate or otherwise resolve these kinds of issues. Our disaster recovery procedures and contingencyplanning rely heavily on third-party providers and may prove insufficient to fully protect Tivic operations and business interests The release of confidential informationmay also lead to litigation or other proceedings against us by affected individuals, business partners and/or regulators, and the outcomeof such proceedings, which could include losses, penalties, fines, injunctions, expenses and charges recorded against our earnings andcause us reputational harm and/or could have a material and adverse effect on our business, financial position or results of operations. We rely on third parties to supplyand manufacture our devices, which could cause supply shortages, and we expect to continue to rely on third parties to manufacture andsupply our devices. We encountered disruptions in our supplyof various materials and components, and electronic components during 2022 due to the well-documented shortages and constraints in theglobal supply chain. This was exacerbated by the resurgence of the COVID-19 pandemic in certain parts of China, which resulted in thetemporary closure of manufacturing facilities, including those that make electronic parts like those that we included in our products,in certain parts of China. Although the supply chain constraints that we faced during the pandemic have primarily subsided, no assurancescan be provided that we will not face similar disruptions in the future. If we experience similar constraints in the future, the supplyor manufacture of our devices could be stopped, delayed or made less profitable if any of these third parties fail to provide us withsufficient quantities at acceptable quality levels or prices, or fail to maintain or achieve satisfactory regulatory compliance. We rely on, and expect to continue torely on, third-party providers for the supply and manufacturing of our devices, including components and electronic parts. Lead timesfor ordered components may vary significantly, and some components used to manufacture our products are provided by a limited number ofsources. We are continuously evaluating alternativeand secondary source suppliers in order to ensure that we are able to source sufficient components and materials to manufacture our products.In the event that we are unable source sufficient components and materials from our current suppliers, or to develop relationships withadditional suppliers, to manufacture enough of our products to satisfy demand, we may have to cease or slow down production of our products.To the extent our current manufacturers or suppliers, or any manufacturers and suppliers that we engage in the future, are unable to meetour requirements in a timely and cost-effective manner, we may not be able to obtain an adequate supply of electronic parts or componentsfor our products. Any shortage of materials caused by any disruption or unavailability of supply or an increase in the demand for ourproducts, could harm our ability to satisfy customer demand, delay deliveries of our products to customers, lead to customer cancellationsand returns, delay the development and launch of new products, or increase our costs and decrease our revenue. Any such impacts or delayscould adversely affect our sales, customer satisfaction, profitability, cash flows and financial condition. and our business may be adverselyaffected. Our efforts to mitigate supply chain weaknesses may not be successful or may have unfavorable effects. We do not control the operationalprocesses of the contract manufacturing organizations with whom we contract and are dependent on these third parties for the productionof our devices in accordance with relevant regulations, which include, among other things, quality control, quality assurance and themaintenance of records and documentation. We may be adversely affected bythe effects of inflation. Inflation has the potential to adverselyaffect our liquidity, business, financial condition and results of operations by increasing our overall cost structure, particularly ifwe are unable to achieve commensurate increases in the prices we charge our customers. The existence of inflation in the economy has resultedin, and may continue to result in, higher interest rates and capital costs, shipping costs, supply shortages, increased costs of labor,weakening exchange rates and other similar effects. As a result of inflation, we have experienced and may continue to experience, costincreases. Although we may take measures to mitigate the impact of this inflation, if these measures are not effective our business, financialcondition, results of operations and liquidity could be materially adversely affected. Even if such measures are effective, there couldbe a difference between the timing of when these beneficial actions impact our results of operations and when the cost inflation is incurred. We depend on our senior managementteam and the loss of one or more key personnel or an inability to attract and retain highly skilled personnel may impair our ability togrow our business. Our future success depends heavily uponthe continued services of our executive officers and key personnel. The Company is headquartered in California, which is an at will employmentstate. Accordingly, the employment agreements that we have entered into with our executive officers and other key personnel do not requirethem to continue to work for us for any specified period and, therefore, they may terminate employment with us at any time, for any reasonand with no advance notice. The replacement of members of our senior management team or other key personnel would likely involve significanttime and costs, and the loss of these employees may significantly delay or prevent the achievement of our business objectives. In addition, our ability to recruit andretain talent in all areas of the business, including but not limited to skilled hires in marketing, product development, regulatory,clinical, quality, logistics, and finance, faces significant competition. We may not be able to hire or retain the type and number ofmanagerial, sales and technical personnel necessary for future success. We will need to devote considerable resources to ensure that weretain our employees in the face of a highly competitive market for talented personnel. If we fail to attract and retain the skilled employeesrequired, this could harm our business and hamper future expansion of our business operations. We rely on third parties for sales,marketing, manufacturing, distribution, and other business operations. For us to be successful, third partiesproviding us with sales, marketing, manufacturing, distribution and other business operations services must be able to provide us withsuch services in compliance with regulatory requirements, in accordance with agreed upon specifications, at acceptable costs, and on atimely basis. While our service providers have generally met our expectations in the past, their ability and willingness to continue todo so going forward, and the ability and willingness of any new service provider to meet our expectations in the future, may be limitedfor several reasons, including our relative importance as a customer. Additionally, we rely on third-party online retailers such as Amazon,BestBuy, Walmart, FSAStore and other specialty online retailers, as well as the parties that we have entered into distribution agreementswith, to sell our products. We do not have long-term agreements in place with certain of these third parties and there is no guaranteethat such third parties will continue to allow us to sell our products through their platforms or channels. Accordingly, we may be exposedto disruptions or reduced qualify of services, including access to distribution channels, due to factors beyond our direct control, whichmay impact our ability to operate successfully. We are currently operatingin a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability,the ongoing military conflicts between Russia and Ukraine and Israel and Hamas, and record inflation. Our business, financial conditionand results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resultingfrom the conflict in Ukraine and the Middle East, geopolitical tensions or record inflation. U.S. and global markets are experiencingvolatility and disruption and the global economy has been, and may continue to be, negatively impacted by Russia’s ongoing militaryconflict with Ukraine. As a result of Russia’s invasion of Ukraine in February 2022, the U.S., the European Union, the United Kingdom,other G7 countries, as well as various other countries, have imposed substantial financial and economic sanctions on certain industrysectors and parties in Russia. Broad restrictions on exports to Russia have also been imposed. These measures include: (i) comprehensivefinancial sanctions against major Russian banks; (ii) additional designations of Russian individuals with significant business interestsand government connections; (iii) designations of individuals and entities involved in Russian military activities; and (iv) enhancedexport controls and trade sanctions limiting Russia’s ability to import various goods. Russian military actions and the resultingsanctions could continue to adversely affect the global economy and financial markets and lead to instability and lack of liquidity incapital markets, potentially making it more difficult for us to obtain additional funds. Addition, in October 2023, Hamas militantsand members of certain other organizations infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attackson civilian and military targets. Shortly thereafter, Israel’s security cabinet declared war against Hamas and launched an aerialbombardment of various targets within the Gaza Strip. It is possible that other countries and/or regional organizations will join thehostilities as well, including without limitation Hezbollah in Lebanon, and Palestinian military organizations in the West Bank, resultingin further expansion of the conflict. The conflict between Israel and Hamas is ongoing, and the length and impact of the ongoing militaryconflict is highly unpredictable. There are also current geopolitical tensionswith China. Recently, the Biden administration has signed multiple executive orders regarding China, including certain executive ordersthat may impact the pharmaceutical industry and other similar industries in the U.S. Moreover, both the U.S. and China have recently imposedsanctions upon certain companies and individuals based in the other country, and have also imposed certain import and export restrictionsand tariffs on products originating from the other country. Any additional executive action, legislative action or potential sanctionswith China could materially impact our current manufacturing partners and our agreements with them. Although our business has not been materiallyimpacted by the ongoing military conflicts between Russia and Ukraine or Israel and Hamas, geopolitical tensions, or record inflationto date, it is impossible to predict the extent to which our operations, or those of our suppliers and manufacturers, will be impactedin the short and long term, or the ways in which the conflict may impact our business. The extent and duration of the conflicts in Ukraineand the Middle East, geopolitical tensions, record inflation, sanctions and resulting market disruptions are impossible to predict, butcould be substantial. Any such disruptions may also magnify the impact of other risks described herein. We may not be able to successfullyidentify, consummate or integrate acquisitions or to successfully manage the impacts of such transactions on our operations. Part of our business strategy includesinvestigating growth through acquisitions. We may expand our business by making strategic acquisitions and seeking suitable acquisitiontargets to enhance our growth. Material acquisitions, dispositions and other strategic transactions involve a number of risks, including:(i) the potential disruption of our ongoing business; (ii) the distraction of management away from the ongoing oversight of our existingbusiness activities; (iii) incurring additional indebtedness; (iv) the anticipated benefits and cost savings of those transactions notbeing realized fully, or at all, or taking longer to realize than anticipated; (v) an increase in the scope and complexity of our operations;(vi) exposure to unknown liabilities; and (vii) the loss or reduction of control over certain of our assets. The pursuit of acquisitions may posecertain risks to us. We may not be able to identify acquisition candidates that fit our criteria for growth and profitability. Even ifwe are able to identify such candidates, we may not be able to acquire them on terms or financing satisfactory to us. We may incur expensesand dedicate attention and resources associated with the review of acquisition opportunities, whether or not we consummate such acquisitions,which may divert management’s attention from our day-to-day business. Additionally, even if we are able to acquiresuitable targets on agreeable terms, we may not be able to successfully integrate their operations with ours. Achieving the anticipatedbenefits of any acquisition will depend in significant part upon whether we integrate such acquired businesses in an efficient and effectivemanner. We may not be able to achieve the anticipated operating and cost synergies or long-term strategic benefits of our acquisitionswithin the anticipated timing, or at all. The benefits from any acquisition will be offset by the costs incurred in integrating the businessesand operations. We may also assume liabilities in connection with acquisitions to which we would not otherwise be exposed. An inabilityto realize any or all of the anticipated synergies or other benefits of an acquisition as well as any delays that may be encountered inthe integration process, which may delay the timing of such synergies or other benefits, could have an adverse effect on our business,results of operations and financial condition. The guarantees and warranties weprovide on our products could have a material adverse effect on our business, financial condition and results of operations. We provide product guarantees to our customers,pursuant to which we allow for the return of products from customers within 60 days after the original sale. We also provide a one-yearwarranty for any defective product. Existing and future product guarantees and warranties place us at the risk of incurring future returnsand repair and/or replacement costs. While we engage in product quality programs and processes, including monitoring and evaluating thequality of our components sourced from our suppliers, our guaranty and warranty obligation is affected by actual product defect rates,parts and equipment costs and service labor costs incurred in correcting a product defect. During the years ended December 31, 2023 and2022, we accrued return reserves equal to approximately 12% and 10%, respectively, of gross revenues. We believe our reserve as of December31, 2023 is adequate. However, our reserves set aside to cover warranty returns and customer returns may be inadequate due to an unanticipatednumber of customer returns, undetected product defects, unanticipated component failures or changes in estimates for material, labor andother costs we may incur to replace projected product defects. As a result, if actual customer returns, product defect rates, parts andequipment costs or service labor costs exceed our estimates, it could have a material adverse effect on our business, financial conditionand results of operations. Risks Related to Our Business andMarkets Our ability to compete in thesinus, cold and allergy market is unproven. We currently compete in the sinus, coldand allergy market segment, a segment with large, entrenched players. We expect to experience competition from current and potential newcompetitors, some of which may be better established and have significantly greater financial, technical, marketing and distribution resources.We encounter competition from larger, well-established and well-financed entities that may continue to acquire, invest in, or form jointventures with producers of alternate sinus care technologies. Our competitors may be able to respondmore quickly to new or emerging technologies and changes in customer requirements than we can. Our market position could erode rapidlyas a result of the development of new, superior products and technology by competitors. In addition, current and potential competitorsmay have greater name recognition, broader physician reach and more extensive customer bases. Increased competition could result in pricereductions, lower volume sales, and reduced gross margins. There can be no assurance that we will be able to compete successfully againstour current or future competitors or that competitive pressures will not have a material adverse effect on our business, financial conditionand results of operations. Our markets are undergoingcontinuous change, and our future success will depend on our ability to meet the changing needs of our customers. For our business to survive and grow,we must continue to enhance and improve our products and technology to address a broader range of customers’ needs. If customerbehavior or new industry standards or practices emerge, our existing technology may become obsolete. Our future success will depend upon,among other things, our ability to: Developing medical technology entailssignificant technical, regulatory and business risks. We may fail to adapt our technology touser requirements or emerging treatment standards. Microcurrent and other neuromodulation therapies are not currently considered standardof care for inflammation and may not ever be considered standard of care. Treatment standards may not evolve to incorporate our product.New industry standards for the development, manufacture and marketing of medical devices may evolve and we may not be able to conformto the changes, meet new standards in a timely fashion or maintain a competitive position in the market. In particular, regulatory standardsfor bioelectronic treatments of medical conditions are evolving. If we face material delays in introducing our products and new technology,we may fail to attract new customers. Customer or third-party complaintsor negative reviews or publicity about our company or our products could harm our reputation and brand. We are heavily dependent on customerswho use our ClearUP device to provide good reviews and word-of- mouth recommendations to contribute to our growth. Customers who are dissatisfiedwith their experiences with our products or services may post negative reviews. We may also be the subject of blog, forum or other mediapostings that include inaccurate statements and/or create negative publicity. In addition, any negative news regarding bioelectronic medicinemay adversely impact our business. Any negative reviews or publicity, whether real or perceived, disseminated by word-of-mouth, by thegeneral media, by electronic or social networking means or by other methods, could harm our reputation and brand and could severely diminishconsumer confidence in our products. We may face risks associated withexpanding to international markets. We may pursue marketing and selling ourproducts internationally, which would likely be primarily done through e-commerce accelerators, distribution arrangements and regionallicensing. We have limited experience operating outside the United States, and we will likely need to rely heavily on distributors andlicensees in the event that we expand internationally. Expansion into international markets may expose us to, among other things, thefollowing additional risks: The size and expected growth ofour available market has not been established with precision and may be smaller than we estimate. Our data on the available market for ourcurrent products and future products is based on a number of internal and third-party research reports, estimates and assumptions. Whilewe believe that such research, our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates maynot be correct. In addition, the statements in this Offering Circular relating to, among other things, the expected growth in the marketfor our ClearUP device are based on a number of internal and third-party data, estimates and assumptions, and may prove to be inaccurate.If the actual number of consumers who would benefit from our products, the price at which we can sell future products or the availablemarket for our products is smaller than we estimate, it could have a material adverse effect on our business, financial condition andresults of operations. Our insurance may not adequatelycover our operating risk or litigation exposure. We have insurance to protect our assets,operations and employees. While we believe our insurance coverage addresses the material risks to which we are exposed and is adequateand customary in our current state of operations, such insurance is subject to coverage limits and exclusions and may not be availablefor the risks and hazards to which we are exposed. Also, our insurance may be insufficient to cover the costs of any securities- relatedor other lawsuits or litigation, regardless of the merits of any such lawsuits or litigation. In addition, no assurance can be given thatsuch insurance will be adequate to cover our liabilities or will be generally available in the future or, if available, that premiumswill be commercially justifiable or affordable. If we were to incur substantial liability and such damages were not covered by insuranceor were in excess of policy limits, or if we were to incur such liability at a time when we are not able to obtain liability insurance,our business, results of operations and financial condition could be materially adversely affected. Our business could be disruptedby catastrophic occurrences and similar events. Our headquarters are located in the SanFrancisco Bay Area, and we are vulnerable to interruption from catastrophic occurrences, such as earthquakes, floods, fires, power loss,telecommunication failures, terrorist attacks, criminal acts, sabotage, other intentional acts of vandalism and misconduct, geopoliticalevents, disease, such as the COVID-19 pandemic, and similar events. The San Francisco Bay Area is a region known for seismic activity.Despite any precautions we may take, the occurrence of a natural disaster or other unanticipated problems at our facilities or the facilitiesof our suppliers and vendors could result in disruptions and other performance and quality problems. If we are unable to develop adequateplans to ensure that our business functions continue to operate during and after a disaster and/or to execute successfully on those plansin the event of a disaster or emergency, our business would be seriously harmed. Risks Related to Legal andRegulatory Matters Changes in the regulatory landscapefor our products could render our business model contrary to applicable regulatory requirements, and we may be required to seek additionalclearance or approval for our products. Our ClearUP device is a US FDA ClassII device with FDA clearance for over-the-counter purchase. We continue to expand our product offerings within the ClearUP brand basedon the architecture used in the ClearUP product line. Such expansions may include design modifications of the ClearUP device. Given thatcurrent improvements to the ClearUP product line are a line extension of the ClearUP device, and based on the approval by our designatedEU Notified Body and our assessment of relevant FDA guidance (Guidance for Industry and Food and Drug Administration Staff “DecidingWhen to Submit a 510(k) for a Change to and Existing Device” October 25, 2017), we have determined that such current expansionsof the ClearUP product line are covered under the same regulatory clearances as ClearUP. If the FDA were to determine that our productsor product candidates do not properly satisfy the conditions for FDA clearance as Class II devices, or that our ClearUP product line expansionis not covered by the same regulatory clearances as our existing ClearUP device, we could be required to cease distribution of our productsuntil we obtain regulatory clearance or approval, abandon new product launch plans, and/or we could be subject to additional enforcementaction by the FDA. All existing FDA clearances, including those covering our ClearUP device, could be subject to change based on subsequentFDA review or changes in FDA regulations. In addition, many states have laws regarding the provision of medical devices, and if we arefound to be in violation of the laws of any state in which our devices are sold, we could be subject to further sanctions at the statelevel. The laws and regulations applicable tothe industries in which we operate are continuously evolving. Changes in our regulatory and legal landscape could substantially increasethe costs of compliance, increase the time and resources required to bring new products to market, or otherwise negatively impact ourbusiness. There can be no assurance that new legislation or regulations will not impose significant additional costs or burdens on ourbusiness or subject us to additional liabilities. We may be or become subject to claims that our operations violate these laws or regulations. Our business is subject to risksarising from epidemic diseases, such as the recent COVID-19 pandemic. The occurrence of regional epidemics ora global pandemic such as COVID-19 may adversely affect our operations, financial condition, and results of operations. The COVID-19 pandemichad widespread, rapidly evolving, and unpredictable impacts on global society, economies, financial markets, and business practices from2020 into 2023. The extent to which global pandemics, including as a result of the lingering effects of COVID-19 on the global economy,impact our business going forward will depend on various factors such as the duration and scope of the pandemic; governmental, business,and individuals’ actions in response to the pandemic; and the impact on economic activity including the possibility of recessionor financial market instability. Measures taken by the governments of countriesaffected by future pandemics could adversely impact our business, financial condition, or results of operations. Potential disruptionsmay include, without limitations, delays in processing registrations or approvals by applicable state or federal regulatory bodies, delaysin product development efforts and/or clinical trials, and additional government requirements or other incremental mitigation effortsthat may further impact our capacity to manufacture, sell and support the use of our ClearUP device or other products. We are subject to consumer protectionlaws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to complywith such obligations could harm our business, and changes in such regulations or laws could require us to modify our products or marketingor advertising efforts. In connection with themarketing or advertisement of our products, we could be the target of claims relating to false, misleading, deceptive or otherwisenoncompliant advertising or marketing practices, including under the auspices of the FTC and state consumer protection statutes. Ifwe rely on third parties to provide any marketing and advertising of our products, we could be liable for, or face reputational harmas a result of, their marketing practices if, for example, they fail to comply with applicable statutory and regulatoryrequirements. If we are found to have breached any consumerprotection, advertising, unfair competition or other laws or regulations, we may be subject to enforcement actions that require us tochange our marketing and business practices in a manner that may negatively impact us. This could also result in litigation, fines, penaltiesand adverse publicity that could cause reputational harm and loss of customer trust, which could have a material adverse effect on ourbusiness, financial condition and results of operations. Our reliance on vendors in foreigncountries, including China, subjects us to risks and uncertainties relating to foreign laws and regulations and changes in relations betweenthe United States and such foreign countries. Electronic components for our ClearUPdevices are sourced primarily from China, and we may in the future source components from vendors located in other foreign countries.Under its current leadership, the government of China has been pursuing economic reform policies, including by encouraging foreign tradeand investment. However, there is no assurance that the Chinese government will continue to pursue such policies, that such policies willbe successfully implemented, that such policies will not be significantly altered, or that such policies will be beneficial to our partnershipsin China. China’s system of laws, as well as the laws of other foreign countries where we may source components, can be unpredictable,especially with respect to foreign investment and foreign trade. The United States government has calledfor substantial changes to foreign trade policy with China and has raised, and has proposed to further raise in the future, tariffs onseveral Chinese goods. China has retaliated with increased tariffs on United States goods. Moreover, China’s legislature has adopteda national security law to substantially change the way Hong Kong has been governed since the territory was handed over by the UnitedKingdom to China in 1997. This law increases the power of the central government in Beijing over Hong Kong, limits the civil libertiesof residents of Hong Kong and could restrict the ability of businesses in Hong Kong to continue to conduct business or to continue towith business as previously conducted. The U.S. State Department has indicated that the U.S. no longer considers Hong Kong to have significantautonomy from China. The U.S. State Department previously enacted sanctions related to China’s governing of Hong Kong, and the U.S.may impose the same tariffs and other trade restrictions on exports from Hong Kong that it places on goods from mainland China. Any furtherchanges in United States trade policy could trigger retaliatory actions by affected countries, including China, resulting in trade wars. Changes to Chinese regulations affectingthe manufacture of electronic components may also be unpredictable. For example, the Uyghur Forced Labor Prevention Act bans imports fromChina’s Xinjiang Uyghur Autonomous Region unless it can be shown that the goods were not produced using forced labor and this legislationmay have an adverse effect on global supply chains which could adversely impact our business and results of operations. Additionally,China has recently implemented significant restrictions on the export of gallium and germanium, both of which are used for the manufactureof computer chips. Changes to regulations in China and/or any other country where we may source components in the future may also be unpredictableand could affect the manufacture of electronic components in such countries and our ability to purchase components on a cost- effectivebasis. Any regulatory changes and changes in United States and China relations, or changes in relations with the United States any othercountry where we may source components in the future, may have a material adverse effect on our vendors in China and other such countrieswhich could materially harm our business and financial condition. International trade disputescould result in tariffs and other protectionist measures that could have a material adverse effect on our business, financial conditionand results of operations. Tariffs, and in particular tariffs imposedon materials imported from China, could increase the cost of our products and raw materials that go into making them. These increasedcosts could adversely impact the gross margin that we earn on our products. Tariffs could also make our products more expensive for customers,which could make our products less competitive and reduce consumer demand. Countries may also adopt other protectionist measures thatcould limit our ability to source components for our products or to offer our products. Political uncertainty surrounding internationaltrade disputes and protectionist measures could also have a negative effect on consumer confidence and spending, which could have a materialadverse effect on our business, financial condition and results of operations. We may in the future become subjectto the requirements of the Sunshine Act. We are not currentlysubject to the Physician Payment Sunshine Act (“Sunshine Act”), which was enacted as part of the Affordable Care Act.However, if we begin selling our products directly to governmental entities or our products become reimbursable by Medicare orMedicaid, then we may become subject to the Sunshine Act, which will require us to report annually to the Secretary of Health andHuman Services: (i) payments or other transfers of value made by us, or by a third-party as directed by us, to physicians andteaching hospitals or to third parties on behalf of physicians or teaching hospitals; and (ii) physician ownership and investmentinterests in our company. The payments required to be reported include the cost of meals provided to a physician, travelreimbursements and other transfers of value, including those provided as part of contracted services such as speaker programs,advisory boards, consultation services and clinical trial services. Failure to comply with the reporting requirements can result insignificant civil monetary penalties ranging from $1,000 to $10,000 for each payment or other transfer of value that is not reported(up to a maximum per annual report of $150,000) and from $10,000 to $100,000 for each knowing failure to report (up to a maximum perannual report of $1.0 million). Additionally, becoming subject to the Sunshine Act and the information we disclose could lead togreater scrutiny, which could result in modifications to established practices and additional costs. Additionally, similar reportingrequirements have also been enacted on the state level domestically, and an increasing number of countries worldwide have eitheradopted or are considering adopting similar laws requiring transparency of interactions with healthcare professionals. Risks Related to Our IntellectualProperty We are highly dependent on our IP,and our methods of protecting our IP may not be adequate or could be costly. We rely on a combination of patent andtrademark laws, trade secrets, confidentiality procedures and contractual provisions to protect our IP rights. We are building our IPportfolio, and may not be able to secure sufficient protection to prevent competition from entering the market or from creating competingproducts. We cannot be certain that we will be ableto obtain patent protection on the key components of our technology or that we will be able to obtain patents in key jurisdictions, suchas the United States, Europe and Asia. We cannot give assurances that we will develop new products or technologies that are patentableor (to the extent applicable) that any new products will be covered by existing patents, that any issued patent will provide us with anycompetitive advantages or will not be challenged by third parties, or that the patents of others will not impair our ability to do business. We cannot guarantee that the applicablegovernmental authorities will approve any of our future trademark applications. Even if the applications are approved, third parties mayseek to oppose or challenge these registrations. A failure to obtain trademark registrations in key jurisdictions could limit our abilityto use our trademarks and impede our marketing efforts in those jurisdictions. Despite our efforts to protect ourIP, unauthorized parties may attempt to copy or obtain and use our technology. Policing the unauthorized use of our technology on a globalbasis is difficult, and there can be no assurance that the steps taken by us will prevent misappropriation of our technology. We cannot give assurances that our measuresfor preserving the secrecy of our trade secrets and confidential information will be sufficient to prevent others from obtaining our tradesecrets. We generally require our employees, consultantsand corporate partners to sign confidentiality and non-disclosure agreements prohibiting them from disclosing any of our trade secrets.Our employment agreements and consulting agreements also contain confidentiality undertakings, as well as non-compete provisions, whichprohibit employees, advisors and consultants from acting contrary to our interests during the period of their relationship with us. Despite our efforts to preserve the secrecyof our trade secrets and confidential information, we may not have adequate remedies to preserve our trade secrets or to compensate usfully for our loss if employees, consultants or corporate partners breach confidentiality agreements with us. We cannot give assurancesthat our trade secrets will provide any competitive advantage, as they may become known to, or be independently developed by, competitors,regardless of the success of any measures we may take to try to preserve their confidentiality. Any failure or inability to protect anyof our IP or confidential information, or to enforce our rights against any infringement or misappropriation of our IP or confidentialinformation, could have a material adverse effect on our business, financial condition and results of operations. Additionally, we maybe forced to litigate to enforce or defend our IP, to protect our trade secrets or to determine the validity and scope of other parties’proprietary rights. Any such litigation could be very costly and could distract our management from focusing on operating our business.The existence and/or outcome of any such litigation could harm our business. We may face risks of claims forIP infringement. Our competitors or other persons mayhave already obtained or may in the future obtain patents or other rights relating to one or more aspects of our technology. Because wehave not conducted a formal freedom to operate analysis for patents related to our technology, we may not be aware of issued patents thata third party might assert are infringed by our current or any future technology, which could materially impair our ability to commercializeour current or any future technology. Even if we diligently search third-party patents for potential infringement by our current or anyfuture technology, we may not successfully find patents that our current or any future technology may infringe. If we are unable to secureand maintain freedom to operate, others could preclude us from commercializing our current or future technology. We may in the futurebecome party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to ourcurrent and any future technology, whether or not we are actually infringing, misappropriating or otherwise violating the rights of thirdparties. If we are sued for patent or other intellectual property right infringement, we may be forced to incur substantial costs in defendingour self. If litigation were to result in a judgmentthat we infringed a valid and enforceable patent or other intellectual property right, a court may order us to pay substantial damagesto the owner of the patent or other intellectual property right and to stop using any infringing technology or products. This could causea significant disruption in our business and force us to incur substantial costs to develop and implement alternative, non-infringingtechnology or products, or to obtain a license from the patent or other intellectual property right owner. We cannot give assurance that we wouldbe able to develop non-infringing alternatives at a reasonable cost that would be commercially acceptable, or that we would be able toobtain a license from any patent or other intellectual property right owner on commercially reasonable terms, if at all. We may be unable to enforceour IP rights throughout the world. The laws of some foreign countries donot protect IP rights to the same extent as the laws of the United States. The area of bioelectronic medicine, specifically, is a nascentand emerging industry. To the extent we demonstrate novel means to manage physiological functions, the nature and degree of IP protectionwe can obtain throughout the world may vary. Many companies have encountered significant problems in protecting and defending IP rightsin certain foreign jurisdictions. This could make it difficult for us to stop infringement of our foreign patents, if obtained, or themisappropriation of our other IP rights. For example, some foreign countries have compulsory licensing laws under which a patent ownermust grant licenses to third parties. In addition, some countries limit the enforceability of patents against certain third parties, includinggovernment agencies or government contractors. In these countries, patents may provide limited or no benefit. Patent protection must ultimatelybe sought on a country-by-country basis, which is an expensive and time-consuming process with uncertain outcomes. Accordingly, we maychoose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries. Proceedings to enforce our patent rightsin foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business. Accordingly,our efforts to protect our IP rights in such countries may be inadequate. In addition, changes in the law and legal decisions by courtsin the United States and foreign countries may affect our ability to obtain adequate protection for our technology and the enforcementof our IP. General Risk Factors If securities or industry analystsdo not publish research or publish unfavorable or inaccurate research about our business, the market price and trading volume of our commonstock could decline. The market price and trading volume ofour common stock is heavily influenced by the way analysts interpret our financial information and other disclosures. We do not have controlover these analysts. If few securities analysts commence coverage of us, or if industry analysts cease coverage of us, our stock pricewould be negatively affected. If securities or industry analysts do not publish research or reports about our business, downgrade ourcommon stock, or publish negative reports about our business, our stock price would likely decline. If one or more of these analysts ceasecoverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock priceto decline and could decrease the trading volume of our common stock. We have and will continue to incurincreased costs and are subject to heightened regulations and requirements as a result of becoming a public company, which could lowerour profits or make it more difficult to run our business. As a public company, we incur significantlegal, accounting and other expenses that we did not incur as a private company, including costs associated with public company reportingrequirements. We also have incurred and will continue to incur costs associated with the Sarbanes-Oxley Act, and related rules implementedby the SEC, and the Nasdaq Capital Market. The expenses generally incurred by public companies for reporting and corporate governancepurposes have been increasing. These rules and regulations have increased and will continue to increase our legal and financial compliancecosts and to make some activities more time-consuming and costlier, although we are currently unable to estimate these costs with anydegree of certainty. These laws and regulations also make it more difficult or costly for us to obtain certain types of insurance, includingdirector and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially highercosts to obtain the same or similar coverage. These laws and regulations may also make it more difficult for us to attract and retainqualified persons to serve on our board of directors, on our board committees or as our executive officers. Furthermore, if we are unableto satisfy our ongoing obligations as a public company, we could be subject to delisting of our common stock, fines, sanctions, otherregulatory action and potentially civil litigation. Actual or perceived failuresto comply with applicable data privacy and security laws, regulations, policies, standards, contractual obligations and other requirementsrelated to data privacy and security and changes to such laws, regulations, standards, policies and contractual obligations could adverselyaffect our business, financial condition and results of operations. The global data protection landscape israpidly evolving, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business.We are subject to numerous state, federal and foreign laws, requirements and regulations governing the collection, transmission, use,disclosure, storage, retention and security of personal and personally-identifying information, such as information that we may collectin connection with conducting our business in the United States and abroad. Implementation standards and enforcement practices are likelyto remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards or perceptionof their requirements may have on our business. This evolution may create uncertainty in our business; affect our ability to operate incertain jurisdictions; or to collect, store, transfer use and share personal information; necessitate the acceptance of more onerous obligationsin our contracts; result in liability or impose additional costs on us. The cost of compliance with these laws, regulations and standardsis high and is likely to increase in the future. Any failure or perceived failure by us to comply with federal, state or foreign lawsor regulation, our internal policies and procedures, or our contracts governing our processing of personal information could result innegative publicity, government investigations and enforcement actions, fines, imprisonment of company officials and public censure, claimsby third parties, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financialcondition and results of operations. Changes in accounting standardsand subjective assumptions, estimates and judgments by management related to complex accounting matters could significantly affect ourfinancial results. U.S. generally accepted accounting principles(“GAAP”) and related pronouncements, implementation guidelines and interpretations with regard to a wide variety of mattersthat are relevant to our business, such as, but not limited to, revenue recognition, stock-based compensation, trade promotions and incometaxes are highly complex and involve many subjective assumptions, estimates and judgments by our management. Changes to these rules ortheir interpretation or changes in underlying assumptions, estimates or judgments by our management could significantly change our reportedresults. We are subject to anti-corruption,anti-bribery, anti-money laundering, and similar laws, and non-compliance with such laws could subject us to criminal or civil liabilityand harm our business, financial condition, and results of operations. We are subject to the U.S. Foreign CorruptPractices Act of 1977, as amended (“FCPA”), U.S. domestic bribery laws, the UK Bribery Act 2010, and other anti-corruptionand anti-money laundering laws in the countries in which we conduct business. Anti-corruption and anti-bribery laws have been enforcedaggressively in recent years and are interpreted broadly to generally prohibit companies, their employees, and their third-party intermediariesfrom authorizing, offering, or providing, directly or indirectly, improper payments or benefits to recipients in the public or privatesector. As we increase our international sales and business and sales to the public sector, we may engage with business partners and third-partyintermediaries to market our products and to obtain necessary permits, licenses, and other regulatory approvals. In addition, we or ourthird-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-ownedor affiliated entities. We can be held liable for the corrupt or other illegal activities of these third- party intermediaries, our employees,representatives, contractors, partners, and agents, even if we do not explicitly authorize such activities. While we have policies andprocedures to address compliance with such laws, there is a risk that our employees and agents will take actions in violation of our policiesand applicable law, for which we may be ultimately held responsible. As we expand internationally, our risks under these laws may increase. Detecting, investigating, and resolvingactual or alleged violations of anti-corruption laws can require a significant diversion of time, resources, and attention from seniormanagement. In addition, noncompliance with anti-corruption, anti-bribery, or anti-money laundering laws could subject us to whistleblowercomplaints, investigations, sanctions, settlements, prosecution, enforcement actions, fines, damages, other civil or criminal penaltiesor injunctions, suspension or debarment from contracting with certain persons, reputational harm, adverse media coverage, and other collateralconsequences. If any subpoenas or investigations are launched, or governmental or other sanctions are imposed, or if we do not prevailin any possible civil or criminal proceeding, our business, financial condition, and results of operations could be harmed. Risks Related to Our Securities andthis Offering We expect that our stock price mayfluctuate significantly, and investors may not be able to resell their shares at or above the price at which they purchased them. An activetrading market for our common stock may never develop. Prior to our initial public offering,you could not buy or sell our common stock publicly. Even though our common stock is now listed on the Nasdaq Capital Market, an activetrading market for our shares may not develop or be sustained following our initial public offering. If an active market for our commonstock does not develop or is not maintained, it may be difficult for you to sell your shares depressing the market price for the shares,or at all. An inactive trading market may also impair our ability to raise capital to continue to fund operations by selling additionalshares of our common stock and may impair our ability to acquire other companies or technologies by using shares of our common stock asconsideration. The market price of shares of our commonstock could be subject to wide fluctuations in response to many risk factors listed in this section, and others beyond our control, including: These and other market and industryfactors may cause the market price and demand for our common stock to fluctuate substantially, regardless of our actual operating performance.In addition, the stock market in general, and medical device companies in particular, have experienced price and volume fluctuations thathave often been unrelated or disproportionate to the operating performance of these companies. In the past, when the market price of astock has been volatile, holders of that stock have on occasion instituted securities class action litigation against the company thatissued the stock. If any of our stockholders were to bring a lawsuit against us, the defense and disposition of the lawsuit could be costlyand divert the time and attention of our management and harm our operating results. If our stock price continues to remain below$1.00, our common stock may be subject to delisting from The Nasdaq Capital Market, which would materially reduce the liquidity of ourcommon stock and have an adverse effect on our market price. On June 28, 2024, we received Notice fromNasdaq that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), as the minimum bid price of our common stock has beenbelow $1.00 per share for 33 consecutive business days. The Notice has no immediate effect on the listing of our common stock, which willcontinue to trade at this time on the Nasdaq Capital Market under the symbol “TIVC.” In accordance with Nasdaq Listing Rule5810(c)(3)(A), we have a period of 180 calendar days, or until December 26, 2024, to regain compliance with the minimum bid price requirement.To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for at least ten consecutive businessdays during this 180 calendar day period. In the event we do not regain compliance by December 26, 2024, we may be eligible for an additional180 calendar day grace period if the Company meets the continued listing requirement for market value of publicly held shares ($1 million)and all other initial listing standards for the Nasdaq Capital Market, with the exception of the minimum bid price, and we provide writtennotice to Nasdaq of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.If we do not regain compliance within the allotted compliance period(s), Nasdaq will provide notice that our common stock will be subjectto delisting from the Nasdaq Capital Market. In that event, we may appeal such delisting determination to a hearings panel. We are currently evaluating our alternativesto resolve the listing deficiency. To the extent that we are unable to resolve the listing deficiency, there is a risk that our commonstock may be delisted from Nasdaq, which would adversely impact liquidity of our common stock, potentially result in even lower bid pricesfor our common stock, and make it more difficult for us to obtain financing through the sale of our common stock. We do not expect to pay any cashdividends for the foreseeable future. We do not expect to pay dividends to ourstockholders at any time in the foreseeable future. Anyone considering investing in our stock should not rely on such investment to providedividend income. Instead, we plan to retain any earnings to establish, maintain and expand our operations and product offerings. In addition,any future debt financing arrangement may contain terms prohibiting or limiting the amount of dividends that may be declared or paid onour stock. Accordingly, investors must rely on sales of their shares after price appreciation, which may never occur, as the only wayto realize any return on their investment. There is no public market for thePre-Funded Warrants being offered in this offering. There is no established public trading marketfor the Pre-Funded Warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend toapply to list the Pre-Funded Warrants on any securities exchange or nationally recognized trading system, including The Nasdaq CapitalMarket. Without an active market, the liquidity of the Pre-Funded Warrants will be limited. We will not receive any meaningfulamount of additional funds upon the exercise of the Pre-Funded Warrants. Each Pre-Funded Warrant will be exercisableuntil it is fully exercised and by means of payment of the nominal cash purchase price upon exercise. Accordingly, we will not receiveany meaningful additional funds upon the exercise of the Pre-Funded Warrants. Holders of the Pre-Funded Warrantspurchased in this offering will have no rights as common stockholders until such holders exercise such warrants and acquire shares ofour common stock. Until holders of the Pre-Funded Warrantsacquire shares of our common stock upon exercise thereof, holders of such Pre-Funded Warrants will have no rights with respect to theshares of our common stock underlying such Pre-Funded Warrants. Upon exercise of the Pre-Funded Warrants, such holders will be entitledto exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date. Significant holders or beneficial holdersof shares of our common stock may not be permitted to exercise the Pre-Funded Warrants that they hold. A holder of the Pre-Funded Warrants willnot be entitled to exercise any portion of any Pre-Funded Warrant that, upon giving effect to such exercise, would cause: (i) the aggregatenumber of shares of our common stock beneficially owned by such holder (together with its affiliates) to exceed 4.99% (or, upon electionof holder, 9.99%) of the number of shares of our common stock outstanding immediately after giving effect to the exercise; or (ii) thecombined voting power of our securities beneficially owned by such holder (together with its affiliates) to exceed 4.99% (or, upon electionof holder, 9.99%) of the combined voting power of all of our securities outstanding immediately after giving effect to the exercise, assuch percentage ownership is determined in accordance with the terms of the Pre-Funded Warrants. As a result, you may not be able to exerciseyour Pre-Funded Warrants for shares of our common stock at a time when it would be financially beneficial for you to do so. In such acircumstance, you could seek to sell your Pre-Funded Warrants to realize value, but you may be unable to do so in the absenceof an established trading market and due to applicable transfer restrictions. We are an “emerging growthcompany” and a “smaller reporting company,” and the reduced public company reporting and disclosure requirements applicableto emerging growth companies and smaller reporting companies may make our common stock less attractive to investors. We qualify as an“emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”). Forso long as we remain an emerging growth company, we are permitted and plan to rely on exemptions from certain disclosurerequirements that are applicable to public companies that are not emerging growth companies. These provisions include, but are notlimited to: being permitted to have only two years of audited financial statements and only two years of management’sdiscussion and analysis of financial condition and results of operations disclosure; an exemption from compliance with the auditorattestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 of theSarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley Act”); not being required to comply with any requirement thatmay be adopted by the Public Company Accounting Oversight Board, or PCAOB, regarding mandatory audit firm rotation or a supplementto the auditor’s report providing additional information about the audit and the financial statements; reduced disclosureobligations regarding executive compensation arrangements in our periodic reports, registration statements and proxy statements; andexemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of anygolden parachute payments not previously approved. In addition, the JOBS Act permits emerging growth companies to take advantage ofan extended transition period to comply with new or revised accounting standards applicable to public companies. We intend to takeadvantage of certain of the exemptions discussed above. In addition, we are currently a “smallerreporting company,” as defined in the Securities Exchange Act of 1934, as amended (“Exchange Act”), and have electedto take advantage of certain of the scaled disclosures available to smaller reporting companies. To the extent that we continue to qualifyas a “smaller reporting company” as such term is defined in Rule 12b-2 under the Exchange Act, after we cease to qualify asan emerging growth company, certain of the exemptions available to us as an “emerging growth company” may continue to be availableto us as a “smaller reporting company,” including exemption from compliance with the auditor attestation requirements pursuantto the Sarbanes-Oxley Act and reduced disclosure about our executive compensation arrangements. We will continue to be a “smallerreporting company” until we have more than $250 million in public float (based on our common stock) measured as of the last businessday of our most recently completed second fiscal quarter or, in the event we have no public float (based on our common stock), annualrevenues of more than $100 million during the most recently completed fiscal year. As a result, the information we providewill be different than the information that is available with respect to other public companies. In this Offering Circular, we have notincluded all of the executive compensation-related information that would be required if we were not an emerging growth company. We cannotpredict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our commonstock less attractive as a result, there may be a less active trading market for our common stock, and the market price of our commonstock may be more volatile. If we are unable to implement andmaintain effective internal control over financial reporting in the future, investors may lose confidence in the accuracy and completenessof our financial reports and the market price of our common stock may decline. As a public company, we are requiredto maintain internal control over financial reporting and to report any material weaknesses in such internal controls. In addition, weare required to furnish a report by management on the effectiveness of our internal controls over financial reporting, pursuant to Section404 of the Sarbanes-Oxley Act. As of December 31, 2023, based on an analysis completed by management, our internal controls were not effectivedue to the existence of a material weakness. The process of designing, implementing and testing the internal control over financial reportingrequired to comply with this obligation is time consuming, costly and complicated. If we identify material weaknesses in our internalcontrol over financial reporting (as we have for the year ended December 31, 2023), if we are unable to comply with the requirements ofSection 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to assert that our internal control over financial reportingis effective, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our commonstock could decline, and we could also become subject to investigations by the stock exchange on which our common stock is listed, theSEC or other regulatory authorities, which could require additional financial and management resources. If our operating and financial performancein any given period does not meet any guidance that we provide to the public, the market price of our common stock may decline. We may, but are notobligated to, provide public guidance on our expected operating and financial results for future periods. Any such guidance will becomprised of forward-looking statements subject to the risks and uncertainties described in this Offering Circular and in our otherpublic filings and public statements. Our actual results may not always be in line with or exceed any guidance we have provided,especially in times of economic uncertainty. If, in the future, our operating or financial results for a particular period do notmeet any guidance we provide or the expectations of investment analysts, or if we reduce our guidance for future periods, the marketprice of our common stock may decline. Even if we do issue public guidance, there can be no assurance that we will continue to do soin the future. Anti-takeover provisions in ourcharter documents, and under Delaware law, could make an acquisition of our company more difficult, limit attempts by our stockholdersto replace or remove our current management and limit the market price of our common stock. Provisions in our amended and restatedcertificate of incorporation, as amended (“Charter”), and amended and restated bylaws, as amended (“Bylaws”),may have the effect of delaying or preventing a change of control or changes in our management. Our Charter and Bylaws include provisionsthat: These provisions may frustrate or preventany attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace membersof our board of directors, which is responsible for appointing the members of our management. In addition, we are governed by the provisionsof Section 203 of the Delaware General Corporation Law, which generally, subject to certain exceptions, prohibits a Delaware corporationfrom engaging in any of a broad range of business combinations with any “interested” stockholder for a period of three yearsfollowing the date on which the stockholder became an “interested” stockholder. Any of the foregoing provisions could limitthe price that investors might be willing to pay in the future for shares of our common stock, and they could deter potential acquirersof our company, thereby reducing the likelihood that you would receive a premium for your shares of our common stock in an acquisition. Our Charter and Bylaws provide thatthe Court of Chancery of the State of Delaware or the federal district court for the District of Delaware will be the exclusive forumfor certain disputes between us and our stockholders, which could result in increased costs for our stockholders to bring a claim andcould limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees. Our Charter and Bylaws providethat, unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery of the State ofDelaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District ofDelaware or other state courts of the State of Delaware) is the exclusive forum for (i) any derivative action or proceeding broughton our behalf; (ii) any action asserting a claim of breach of fiduciary duty owed by, or other wrongdoing by, any director, officer,employee or agent of the Company to the Company or our stockholders, creditors or other constituents; (iii) any action asserting aclaim against us arising pursuant to the Delaware General Corporation Law, our Charter or our Bylaws; (iv) any action to interpret,apply, enforce or determine the validity of our Charter or our Bylaws; or (v) or any action asserting a claim against us that isgoverned by the internal affairs doctrine; provided that, the exclusive forum provision will not apply to suits brought to enforceany liability or duty created by the Securities Act, Exchange Act or any other claim for which the federal courts have exclusivejurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action forlack of subject matter jurisdiction, or the Company consents in writing to the selection of an alternative forum, such action may bebrought in another state or federal court sitting in the State of Delaware. Our Charter and Bylaws also provide that the federaldistrict courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause ofaction against us or any of our directors, officers, employees or agents and arising under the Securities Act or Exchange Act.Nothing in our Charter or Bylaws preclude stockholders that assert claims under the Exchange Act from bringing such claims in stateor federal court, subject to applicable law. We believe these provisions may benefitus by providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable,particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to otherforums and protection against the burdens of multi-forum litigation. However, this choice of forum provision could result in increasedcosts for our stockholders to bring a claim and could may limit a stockholder’s ability to bring a claim in a judicial forum thatit finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuitswith respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws andthe rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’certificates of incorporation has been challenged in legal proceedings, and it is possible that a court could find these types of provisionsto be inapplicable or unenforceable. While the Delaware courts have determined that such choice of forum provisions are facially valid,a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions, and therecan be no assurance that such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choiceof forum provision that will be contained in our Charter and Bylaws to be inapplicable or unenforceable in an action, we may incur additionalcosts associated with resolving such action in other jurisdictions, which could adversely affect our business and financial condition. Purchasers in the offering willsuffer immediate dilution. If you purchase Offered Shares (or Pre-Funded Warrantsin lieu thereof) in this offering, the value of your shares based on our pro forma net tangible book value will immediately be less thanthe offering price you paid. This reduction in the value of your equity is known as dilution. At an assumed public offering price of $3.00per share, which represents the high end of the offering price range herein, purchasers of common stock in this offering will experienceimmediate dilution of approximately $1.24 per share, representing the difference between the assumed public offering price per share inthis offering and our pro forma net tangible book value per share as of June, 30, 2024, after giving effect to this offering, and afterdeducting estimated offering expenses, including placement agent fees, payable by us. See “Dilution.” You may experience future dilutionas a result of future equity offerings or acquisitions. In order to raise additionalcapital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for ourcommon stock at prices that may not be the same as the price per share in this offering. We may sell shares or other securities in anyfuture offering at a price per share that is less than the price per share paid by investors in this offering, and investors purchasingshares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additionalshares of our common stock, or securities convertible or exchangeable into our common stock, in future transactions or acquisitions maybe higher or lower than the price per share paid by investors in this offering. In addition, we may engagein one or more potential acquisitions in the future, which could involve issuing our common stock as some or all of the considerationpayable by us to complete such acquisitions. If we issue common stock or securities linked to our common stock, the newly issued securitiesmay have a dilutive effect on the interests of the holders of our common stock. Additionally, future sales of newly issued shares usedto effect an acquisition could depress the market price of our common stock. This is a “best efforts”offering; no minimum amount of Offered Shares is required to be sold, and we may not raise the amount of capital we believe is requiredfor our business. There is no required minimumnumber of Offered Shares (or Pre-Funded Warrants) that must be sold as a condition to completion of this offering. Because there is nominimum offering amount required as a condition to the closing of this offering, the actual offering amount, and proceeds to us are notpresently determinable and may be substantially less than the maximum amounts set forth in this Offering Circular. We may sell fewer thanall of the Offered Shares (or Pre-Funded Warrants) offered hereby, which may significantly reduce the amount of proceeds received by us,and investors in this offering will not receive a refund in the event that we do not sell an amount of Offered Shares (or Pre-Funded Warrants)sufficient to pursue the business goals outlined in this Offering Circular. Thus, we may not raise the amount of capital we believe isrequired for our business and may need to raise additional funds, which may not be available or available on terms acceptable to us. Despitethis, any proceeds from the sale of the Offered Shares (or Pre-Funded Warrants in lieu thereof) offered by us will be available for ourimmediate use, and because there is no escrow account and no minimum offering amount in this offering, investors could be in a positionwhere they have invested in us, but we are unable to fulfill our objectives due to a lack of interest in this offering. Our management will have broaddiscretion over the use of the net proceeds from this offering. We currently intend touse the net proceeds from the sale of Offered Shares (or Pre-Funded Warrants in lieu thereof) under this offering for marketing and advertisingexpenses and general corporate purposes, including working capital. We have not reserved or allocated specific amounts for any of thesepurposes and we cannot specify with certainty how we will use the net proceeds. See “Use of Proceeds”. Accordingly, our managementwill have considerable discretion in the application of the net proceeds, and you will not have the opportunity, as part of your investmentdecision, to assess whether the proceeds are being used appropriately. We may use the net proceeds for corporate purposes that do notincrease our operating results or market value. If you invest in our commonstock in this offering, your ownership interest will be diluted immediately to the extent of the difference between the public offeringprice per share of our common stock and the pro forma net tangible book value per share of our common stock after this offering. Our historical net tangiblebook value as of June 30, 2024, was $4.19 million, or $0.68 per share of common stock based on 6,183,592 shares of common stock outstandingas of June 30, 2024. Historical net tangible book value per share is calculated by subtracting our total liabilities from our total tangibleassets, which is total assets less intangible assets, and dividing this amount by the number of shares of common stock outstanding asof such date. After giving further effectto the assumed sale by us of the Offered Shares at an assumed public offering price of $3.00 per share (which represents the high endof the offering price range herein), and after deducting estimated offering expenses, including placement agent fees payable by us, ourpro forma net tangible book value as of June 30, 2024 would have been approximately $22.64 million or $1.76 per share of common stock.This represents an immediate increase in the net tangible book value of $1.08 per share to our existing stockholders and an immediateand substantial dilution in net tangible book value of $1.24 per share to new investors. The following table illustrates this hypotheticalper share dilution: A $0.10 increase (decrease)in the assumed public offering price of $3.00 per Offered Share, would increase (decrease) the pro forma net tangible book value per shareby $0.05, and increase dilution to new investors by $0.05 per share, in each case assuming that the number of Offered Shares offered byus, as set forth on the cover page of this Offering Circular, remains the same and after deducting estimated offering expenses payableby us, including placement agent fees. The pro forma informationdiscussed above is illustrative only. Our net tangible book value following the completion of this offering is subject to adjustment basedon the actual public offering price of our Offered Shares and other terms of this offering determined at pricing. The number of shares of commonstock outstanding as of June 30, 2024, as shown above, is based on 6,183,592 shares of common stock issued and outstanding as of thatdate and excludes: The table below sets forth the estimated proceedswe would derive from this offering, assuming the sale of 25%, 50%, 75% and 100% of the Offered Shares at an assumed per share price of$3.00, which represents the high end of the offering price range herein. There is, of course, no guaranty that we will be successful inselling any of the Offered Shares (or Pre-Funded Warrants in lieu thereof) in this offering. We intend to use the net proceeds from thisoffering for working capital and general corporate purposes, which may include operating expenses, research and development, and pendingand future acquisitions. We have not determined the amount of net proceeds to be used specifically for any of such purposes. Although we may, from time to time, evaluatepotential strategic investments and acquisitions, we do not have any definitive agreements in place to make any such acquisitions at thiscurrent time. Our expected use of net proceeds from thisoffering and our existing cash and cash equivalents represents our intentions based upon our current plans and business conditions, whichcould change in the future as our plans and business conditions evolve. As a result, we cannot predict with any certainty our use of thenet proceeds from this offering or the amounts that we will actually spend on each area of use set forth above. Our management will retainbroad discretion over the allocation of the net proceeds from this offering. Accordingly, we will have discretion in the application ofthe net proceeds, and investors will be relying on our judgment regarding the application of the proceeds of this offering. Pending our use of the net proceeds fromthis offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade,interest-bearing instruments and U.S. government securities. In the event we do not obtainthe entire offering amount hereunder, we may attempt to obtain additional funds through private offerings of our securities or by borrowingfunds. Currently, we do not have any committed sources of financing. In General Our company is offering a maximum of 6,666,667 OfferedShares on a “best-efforts” basis, at a fixed price of $1.00 to $3.00 per Offered Share (to be fixed by post-qualificationsupplement). There is no minimum purchase requirement for investors in this offering. This offering will terminate at the earliest of(a)the date on which the maximum offering has been sold, (b)the date which is one year from this offering being qualifiedby the SEC or (c) the date on which this offering is earlier terminated by us, in our sole discretion. We are also offering to thosepurchasers, if any, whose purchase of Offered Shares in this offering would otherwise result in such purchaser, together with its affiliatesand certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding sharesof common stock immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses,pre-funded warrants (“Pre-Funded Warrants”) in lieu of the Offered Shares that would otherwise result in such purchaser’sbeneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock. The purchaseprice of each Pre-Funded Warrant will be equal to the public offering price per Offered Shares sold in this offering minus $0.001, theexercise price per share of common stock of each Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable and may be exercisedat any time until all of the Pre-Funded Warrants are exercised in full. For each Pre-Funded Warrantwe sell, the number of Offered Shares we are offering will be decreased on a one-for-one basis. The shares of common stock issuable fromtime to time upon exercise of the Pre-Funded Warrants are also being offered by this Offering Circular. There is no minimum numberof Offered Shares (or Pre-Funded Warrants in lieu thereof) that we are required to sell in this offering. All funds derived by us fromthis offering will be immediately available for use by us, in accordance with the uses set forth in the section entitled “Use of Proceeds” of this Offering Circular. No funds will be placed in an escrow account during the offering period and no funds will bereturned once an investor’s subscription agreement has been accepted by us. The Securities will be offered by Maxim Group LLC,a broker-dealer registered with the SEC and a member of FINRA (“Maxim,” or the “Placement Agent”), on a “bestefforts” basis pursuant to the placement agency agreement to be entered into between us and Maxim, which we refer to as the “PlacementAgent Agreement”. Pursuant to the Placement Agent Agreement, we will pay the Placement Agent, concurrently with each closing ofthis offering, a cash placement fee equal to 7.0% of the gross proceeds of such closing. In addition, we will also pay the Placement Agentup to $50,000 for fees and expenses of legal counsel and other out-of-pocket expenses out of the proceeds of the initial closing and upto $10,000 for fees and expenses of legal counsel and other out-of-pocket expenses out of each subsequent closing. We or the Placement Agent may also ask other FINRAmember broker-dealers that are registered with the SEC to participate as soliciting dealers for this offering. Procedures for Subscribing If you are interested insubscribing for Securities in this offering, please submit a request for information by e-mail to Syndicate Department at Maxim GroupLLC at: syndicate@maximgrp.com; all relevant information will be delivered to you by return e-mail. Thereafter, should you decide to subscribefor Securities, you are required to follow the procedures described in the subscription agreement included in the delivered information,which are: • Electronicallyexecute and deliver to us a subscription agreement; and • Deliver funds directlyby check or by wire or electronic funds transfer via ACH to our specified bank account. Right to Reject Subscriptions After we receive your complete,executed subscription agreement and the funds required under the subscription agreement have been transferred to us, we have the rightto review and accept or reject your subscription in whole or in part, for any reason or for no reason. We will return all monies fromrejected subscriptions immediately to you, without interest or deduction. State Law Exemption and Offerings to “QualifiedPurchasers” The Offered Shares are beingoffered and sold to “qualified purchasers” (as defined in Regulation A under the Securities Act). As a Tier 2 offering pursuantto Regulation A under the Securities Act, this offering will be exempt from state “Blue Sky” law review, subject to certainstate filing requirements and anti-fraud provisions, to the extent that the Offered Shares offered hereby are offered and sold only to“qualified purchasers”. “Qualified purchasers”include any person to whom securities are offered or sold in a Tier 2 offering pursuant to Regulation A under the Securities Act. We reservethe right to reject any investor’s subscription in whole or in part for any reason, including if we determine, in our sole and absolutediscretion, that such investor is not a “qualified purchaser” for purposes of Regulation A. We intend to offer and sell theOffered Shares to qualified purchasers in every state of the United States. Issuance of Offered Shares Upon settlement, that is,at such time as an investor’s funds have cleared and we have accepted an investor’s subscription agreement, we will eitherissue such investor’s purchased Offered Shares in book-entry form or issue a certificate or certificates representing such investor’spurchased Offered Shares. Transferability of the Offered Shares
Commissions(2) Proceeds to Company(3) Per Share (or Pre-Funded Warrant) – $ 3.00 $ 0.21 $ 2.79 Total Minimum – $ – $ – $ – Total Maximum 6,666,667 $ 20,000,001 $ 1,400,001 $ 18,600,000
(1) Assumes a public offering price of $3.00 per share and $2.999 per Pre-Funded Warrant, which represents the high end of the offering price range of $1.00 to $3.00 per share. (2) We have engaged Maxim Group LLC (“the “Placement Agent”), to act as placement agent for this offering, in exchange for a fee of 7% of the aggregate offering price of the Offered Shares (or Pre-Funded Warrants in lieu thereof) sold. (3) Does not account for the payment of legal fees, costs and expenses in connection with the Offering estimated at $150,000. See “Plan of Distribution.”
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS 1 OFFERING CIRCULAR SUMMARY 2 OFFERING SUMMARY 9 RISK FACTORS 12 DILUTION 37 USE OF PROCEEDS 38 PLAN OF DISTRIBUTION 39 DESCRIPTION OF CAPITAL STOCK 41 DESCRIPTION OF SECURITIES WE ARE OFFERING 45 BUSINESS 47 MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 66 DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS 85 EXECUTIVE COMPENSATION 92 MARKET PRICE OF AND DIVIDENDS ON THE COMPANY’S COMMON STOCK AND RELATED STOCKHOLDER MATTERS 102 SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 103 CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS 104 DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES 105 EXPERTS 105 LEGAL MATTERS 105 WHERE YOU CAN FIND MORE INFORMATION 105 INDEX TO FINANCIAL STATEMENTS F-1 i · our anticipated needs for working capital; · our need and ability to secure additional financing; · our business plans and strategies, including our product development efforts; · regulatory or legal developments in the United States and other countries; · developments or disputes concerning patent applications, issued patents or other proprietary rights; · the level of expenses related to our product development and operations; and · our efforts to expand our products and our business. 1 2 3 · Ten issued patents and ten additional international and U.S. patents pending; · Three regulatory clearances: (US FDA 510(k) number K182025, US FDA De Novo numberDEN200006 and EU CE Mark Certificate number CE 704687) for use of ClearUP to treat sinus pain, pressure and congestion; and · Published, peer-reviewed studies in high-impact academicjournals. 4 · our limited operating history; · our cash and financial resources may be insufficient to meet our anticipated needsfor the next twelve months, which raises substantial doubt about our ability to continue as a going concern; · the volatility of our operating results; · our ability to manage growth as the business scales; · we have identified a material weakness in our internal control over financial reportingassociated with staffing levels, which is common for the stage and size of the Company; · our history of net losses; · our need for additional capital, which may not be available on favorable terms, if at all; · our ability to generate revenues sufficient to achieve profitability and positive cash flow; · competition in our industry and our ability to compete effectively; · our ability to attract, recruit, retain and develop key personnel and qualified employees; · economic uncertainty, capital markets disruption, international conflicts, supplychain constraints, inflation, and a potential recession, among other things; · risks related to laws, regulations and industry standards; · risks related to the medical device industry; · reliance on significant third-party service providers; · reliance on our management team; · this is a reasonable best efforts offering, in which no minimum number or dollaramount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans; · resales of our shares of our common stock in the public market by investors in thisoffering may cause the market price of our shares of common stock to fall; · There is no public market for the Pre-Funded Warrants being offeredin this offering. · Holders of the Pre-Funded Warrants will have no rights as holdersof Common Stock until such warrants are exercised. · The Pre-Funded Warrants are speculative in nature. · Holders of the Pre-Funded Warrants purchased in this offering will have no rights as common stockholders until such holders exercise such warrants and acquire shares of our common stock. · this offering may cause the trading price of our shares of common stock to decrease; · our management will have broad discretion over the use of the net proceeds fromthis offering, you may not agree with how we use the proceeds, and the proceeds may not be invested successfully; and · the other factors described in “Risk Factors.” 5 · In February, Tivic received successful recertification to ISO 13485, the internationalstandard for medical device quality systems. This allowed Tivic, in early 2023, to recertify under the European Union Medical Device Certificate(CE-Mark). · In March, we completed supplier qualification and first article inspections atALOM Technologies Corporation (“ALOM”) and Microart Services Inc. (“Microart”), allowing Tivic to reduce assemblyproduction costs by 40% and improve gross margins substantively by end of year. · In April, we completed a 2000-person marketing segmentation study to inform ouradvertising and pricing structure. We subsequently implemented a price increase for ClearUP that negatively impacted direct sales andretail order volumes in Q2, but substantively improved gross profit throughout the course of the year. · In May, we launched a B2B portal to support our strategy to increase physicianand healthcare provider engagement, including physician resale and recommendation programs for ClearUP. · In late June, we entered into a non-exclusive distribution agreement with CardinalHealth for our products. · In late August, we entered into anon-exclusive agreement with AmerisourceBergen, soon to be Cencora, to make our products available on AmerisourceBergen’sthird-party marketplace. · In late September, we entered into anagreement with InStep Health® to introduce ClearUP to over 2,500 healthcare providers andtheir patients. · In Q3, we initiated and subsequently launched a printed circuit board redesign toaddress charging issues associated with a purchased component used in ClearUP. The redesigned circuitry began shipping in late December2023 and launched formally as ClearUP 2.0 in January 2024. · In early April, we filed our first patent in VagusNerve Stimulation with the USPTO, expanding our IP portfolio into new clinical targets. · In mid-April, we announced a research collaboration with The Feinstein Institutesfor Medical Research to conduct a pilot clinical study that will test a novel non-invasive bioelectronic device approach for vagus nervestimulation. · In July, we announced that the USPTO had issued us a sixth patent for our bioelectronicplatform, expanding our IP portfolio to include the proprietary contacts, conductive circuitry design, and algorithms to optimize therapydelivery in our handheld monopolar design. · In August, we received study approval from the Institutional Review Board (“IRB”)of The Feinstein Institutes for Medical Research and initiated study recruitment and enrollment for our vagus nerve program. · We expanded our post-operative pain clinical study to include Otolaryngology andFacial Plastic Surgery patients. This study aims to investigate the potential benefits of a drug-free alternative to traditional post-operativepain management methods. 6 · We launched ClearUP 2.0 and decommissioned older models. The new version included new power managementcircuitry and improved power management for faster charging and longer battery life. · We entered a limited exclusive distribution agreement with McKesson Medical, one of the Top 10 MedicalEquipment Distributors and Suppliers in the nation. Under the terms of the agreement, McKesson affiliate Simply Medical will have certainexclusive distribution rights for Tivic Health’s ClearUP product for Walmart, Target, eBay and Kroger, as well as non-exclusivedistribution rights in other specified on-line channels. · We announced completion of enrollment in a pilot clinical study with The FeinsteinInstitutes for Medical Research, testing a proprietary approach to non-invasive vagus nerve stimulation, for which we publicly announcedthe final data analysis results on May 8, 2024. · We continued to invest in our intellectual property portfolio, filing our first vagus nerve stimulationpatent and prosecuting existing filings. · We have continued to intentionally maintain a small core team at this stage of the Company, includingfurther decreasing our headcount in Q2 2024 to reduce operating expenses. We have relied, and continue to rely, heavily on third-partyservice providers, including marketing agencies, a fulfillment warehouse, software-as-a-service platforms, clinical research organizations,academic research partnerships, finance and accounting support, and legal support to carry out our operations. 7 · MILESTONE 1: Execute Collaboration and Research Support Agreement - $24,485.60 · MILESTONE 2: Receive IRB study approval - $48,971.20 · MILESTONE 3: Complete enrollment of first all participants and run 1/3 sessions - $85,699.60 · MILESTONE 4a/b: Complete all sessions; submit final report - $85,699.60 8 9
Shares of common stock outstanding before the offering 6,183,592 shares of common stock issued and outstanding as of August 12, 2024. Common stock offered by us Offering Price Per Share A price between $1.00 to $3.00 per Offered Share (to be fixed by post-qualification supplement). Pre-Funded Warrants offered by us Shares Outstanding After This Offering (1) 10
None. Investor Suitability Standards The Offered Shares (or Pre-Funded Warrants in lieu thereof) are being offered and sold to “qualified purchasers” (as defined in Regulation A under the Securities Act of 1933, as amended (the “Securities Act”)). “Qualified purchasers” include any person to whom securities are offered or sold in a Tier 2 offering pursuant to Regulation A under the Securities Act. Market for our Common Stock Our common stock is listed on Nasdaq under the symbol “TIVC.” Termination of this Offering This offering will terminate at the earliest of (a)the date on which all of the Offered Shares have been sold, (b)the date which is one year from this offering being qualified by the SEC and (c)the date on which this offering is earlier terminated by us, in our sole discretion. (See “Plan of Distribution”). Use of Proceeds We intend to use the net proceeds of this offering for working capital and general corporate purposes. We have not determined the amount of net proceeds to be used specifically for any of such purposes, will have broad discretion in the way that we use the net proceeds of this offering. See “Use of Proceeds”. Risk Factors An investment in the Offered Shares (or Pre-Funded Warrants in lieu thereof) involves a high degree of risk and should not be purchased by investors who cannot afford the loss of their entire investments. You should carefully consider the information included in the Risk Factors section of this Offering Circular, as well as the other information contained in this Offering Circular, prior to making an investment decision regarding the Offered Shares (or Pre-Funded Warrants in lieu thereof).
· 66,367 shares of common stock issuable upon exercise of options to purchase shares of common stock outstanding as of August 12, 2024, with a weighted-average exercise price of approximately $28.34 per share; · 59,497 shares of common stock issuable upon exercise of outstanding warrants to purchase shares of common stock, with a weighted-average exercise price of approximately $29.34 per share; · up to 4,710,000 shares of common stock issuable upon exercise of Series A Warrants outstanding; · up to 7,065,000 shares of common stock issuable upon exercise of the Series B Warrants outstanding; · up to 188,400 shares of common stock issuable upon exercise of Placement Agent Warrants to be issued to the placement agent or its designees as compensation in connection with this offering at an exercise price of $0.935 per share; and · 928,412 shares of common stock reserved for future issuance under our Amended and Restated 2021 Equity Incentive Plan (“A&R 2021 Plan”). 11 · We have a relatively limited operating history and may not be able to execute on our business strategy. · Our cash and financial resources may be insufficient to meet our anticipated needs for the next twelvemonths, which raises substantial doubt about our ability to continue as a going concern. · · Our operating results may be volatile and may not be a reliable indicator of our future performance. · If we fail to manage our growth effectively, including with respect to potential acquisitions of othercompanies, our business could be materially and adversely affected. · We have a history of net losses, and we may not achieve or maintain profitability in the future. · We have identified a material weakness in our internal control over financial reporting associated withstaffing levels, which is common for the stage and size of the Company. · We expect that we will need additional capital, which, if obtainable, could dilute the ownership interestof investors. · Our business plan depends heavily on product revenues from our core technology, the clinical and consumeracceptance of which is at this time unproven. · We rely on third parties to supply and manufacture our devices, and we expect to continue to rely onthird parties to manufacture and supply our devices. · We may be adversely affected by the effects of inflation. · We depend on our senior management team, and the loss of one or more key personnel or an inability toattract and retain highly skilled personnel may impair our ability to grow our business. · Economic uncertainty and capital markets disruption, which has been significantly impacted by geopoliticalinstability, could harm our financial condition and results of operations. 12 · The guarantees and warranties we provide on our products could have a material adverse effect on ourbusiness, financial condition and results of operations. · Our markets are undergoing continuous change, and our future success will dependon our ability to meet the changing needs of our customers. · Developing medical technology entails significant technical, regulatory and business risks. · The size and expected growth of our available market has not been established withprecision and may be smaller than we estimate. · Our insurance may not adequately cover our operating risk. · Our business could be disrupted by catastrophic occurrences and similar events. · Changes in the regulatory landscape for our products could render our business modelcontrary to applicable regulatory requirements, and we may be required to seek additional clearance or approval for our products. Additionally,we have relied on guidance documents from FDA and our EU Notified Body to make determinations about the regulatory pathway for futureproducts, which may be interpreted to a different effect by the governing regulatory bodies. · We are subject to consumer protection laws that regulate our marketing practicesand prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business,and changes in such regulations or laws could require us to modify our products or marketing or advertising efforts. · Our reliance on vendors in foreign countries, including China, subjects us to risksand uncertainties relating to foreign laws and regulations and changes in relations between the United States and such foreign countries. · We are highly dependent on our intellectual property (“IP”) and ourmethods of protecting our IP may not be adequate or could be costly. In addition, we may face risks of claims for IP infringement. Wemay be unable to enforce our intellectual property rights throughout the world. · Our stock price has fluctuated significantly since our IPO, and may continue tofluctuate significantly, and investors may not be able to resell the securities that they purchase at or above the price at which theypurchased them. An active trading market for our common stock may never develop or be sustained. · We do not expect to pay any cash dividends for the foreseeable future. · Future issuances of stock or other securities could dilute the holdings of our stockholdersand could materially affect the price of our common stock. · We are an “emerging growth company” and a “smaller reporting company,”and the reduced public company reporting and disclosure requirements applicable to emerging growth companies and smaller reporting companiesmay make our common stock less attractive to investors. · If we are unable to implement and maintain effective internal control over financialreporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports and the market priceof our common stock may decline. · If our operating and financial performance in any given period does not meet anyguidance that we provide to the public, the market price of our common stock may decline. · This is a reasonable best efforts offering, in which no minimum number or dollaramount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans. 13
· There is no public market for the Pre-Funded Warrants being offered in this offering. · Holders of the Pre-Funded Warrants will have no rights as holders of Common Stock until such warrants are exercised. · The Pre-Funded Warrants are speculative in nature. · Holders of the Pre-Funded Warrants purchased in this offering will have no rights as common stockholders until such holders exercise such warrants and acquire shares of our common stock. · Resales of our shares of our common stock in the public marketby investors in this offering may cause the market price of our shares of our common stock to fall. · receptiveness of the market to a fundamentally new way of treating target conditions; · intrinsic variability in spending patterns associated with the conduct of clinical trials; · disruptions to the global supply chain and inflationary pressures; · fluctuations in demand for our technology, including seasonal variations; and · delays in introducing new technology to market, including product design, manufacturing,marketing cycles, sales and distribution related delays. 14 15 16 17 · a third party, · natural disaster, · a failure of hardware or software due to a design or programmatic flaw, · a failure of hardware or software security controls, · telecommunications system failure, · service provider error or failure, · fraudulent transactions, · intentional or unintentional personnel actions, · lost connectivity to our networked resources, or · a failure of disaster recovery system. 18 19 20 21 · develop and license new technologies that address the increasingly sophisticated and varied needs ofprospective customers; · stay ahead of technological advances and emerging industry standards and practices on a cost-effectiveand timely basis; and · monitor and stay ahead of shifts in the competitivelandscape. 22 · strain on our managerial resources; · pricing pressure that we may experience internationally; · a shortage of high-quality e-commerce accelerators, distributors, and licensees; · competitive disadvantage to competition with established business and customer relationships; · foreign currency exchange rate fluctuations; · the imposition of additional U.S. and foreign governmental controls or regulations; · economic instability; · changes in duties and tariffs, license obligations and other non-tariff barriers to trade; · the imposition of restrictions on the activities of foreign agents, representatives and distributors; · scrutiny of foreign tax authorities which could result in significant fines, penaltiesand additional taxes being imposed on us; · laws and business practices favoring local companies; · difficulties in maintaining consistency with our internal guidelines; · difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; · the imposition of costly and lengthy new export licensing requirements; · the imposition of U.S. or international sanctions against a country, company, personor entity with whom we do business that would restrict or prohibit continued business with the sanctioned country, company, person orentity; and · the imposition of new trade restrictions. 23 24 25 26 27 28 29 30 · the effect of macroeconomic factors on our business and operations and on marketconditions generally; · the success of our products and of competitive products or technologies; · regulatory or legal developments in the United States and other countries; · the level of expenses related to our products or development programs; · announcements by us, our partners or our competitors of new products or therapies,significant contracts, strategic partnerships, joint ventures, collaborations, commercial relationships, or capital commitments; · failure to meet or exceed financial estimates and projections of the investmentcommunity or that we provide to the public; · issuance of new or updated research or reports by securities analysts or recommendations for our stock; · disputes or other developments related to proprietary rights (including patents),litigation matters, and our ability to obtain patent protection for our technologies; · commencement of, or our involvement in, litigation; · fluctuations in the valuation of companies perceived by investors to be comparable to us; · manufacturing disputes or delays; · any future sales of our common stock or other securities; · any change to the composition of the board of directors or key personnel; · general economic conditions and slow or negative growth of our markets; · share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; · announcement or expectation of additional debt or equity financing efforts; and · other factors described in this section of the Offering Circular. 31 32 33 · authorize our board of directors to issue, without further action by the stockholders,shares of undesignated preferred stock with terms, rights, and preferences determined by our board of directors that may be senior toour common stock; · require that any action to be taken by our stockholders be effected at a duly calledannual or special meeting and not by written consent; · specify that special meetings of our stockholders can be called only by our boardof directors, the chairperson of our board of directors, our Chief Executive Officer or our President (in the absence of a Chief ExecutiveOfficer); · establish an advance notice procedure for stockholder proposals to be brought beforean annual meeting, including proposed nominations of persons for election to our board of directors; · prohibit cumulative voting in the election of directors; · establish that our board of directors will be divided into three classes—Class I, Class II, and Class III—with each class serving staggered three-year terms; · provide that, so long as our board of directors is classified, directors may only be removed for cause; · provide that vacancies on our board of directors may be filled only by a majorityof directors then in office, even though less than a quorum; and · require the approval of our board of directors or the holders of two-thirds of ouroutstanding shares of voting stock to amend our Bylaws and certain provisions of our Charter. 34 35 36
Assumed public offering price per share $ 3.00 Historical net tangible book value per share as of June 30, 2024 $ 0.68 Increase in pro forma net tangible book value per share attributable to this offering $ 1.08 Pro forma net tangible book value per share as of June 30, 2024 after giving effect to this offering $ 1.76 Dilution per share to purchasers of Offered Shares in this offering $ 1.24 • 54,369 shares of common stock issuable upon exercise of options to purchase sharesof common stock outstanding as of June 30, 2024, with a weighted-average exercise price of approximately $34.52 per share; • 59,497 shares of common stock issuable upon exercise of outstanding warrants topurchase shares of common stock, with a weighted-average exercise price of approximately $29.34 per share; • up to 4,710,000 shares of common stock issuable upon exercise of Series A Warrantsoutstanding; • up to 7,065,000 shares of common stock issuable upon exercise of the Series B Warrantsoutstanding; • up to 188,400 shares of common stock issuable upon exercise of Placement Agent Warrantsto be issued to the placement agent or its designees as compensation in connection with this offering at an exercise price of $0.935 pershare; and • 32,786 shares of common stock reserved for future issuance under our 2021 Equity Incentive Plan (“2021 Plan”). 37
Assumed Percentage of Offered Shares Sold in This Offering 25% 50% 75% 100% Offered Shares sold 1,666,667 3,333,334 5,000,000 6,666,667 Gross proceeds $ 5,000,000 $ 10,000,000 $ 15,000,000 $ 20,000,001 Commissions (1) (350,000 ) (700,000 ) (1,050,000 ) (1,400,001 ) Offering expenses(2) (150,000 ) (150,000 ) (150,000 ) (150,000 ) Net proceeds $ 4,500,000 $ 9,150,000 $ 13,800,000 $ 18,450,000 (1) We have engaged Maxim Group LLC (“the “Placement Agent”), to act as placement agent for this offering, in exchangefor a fee of 7% of the aggregate offering price of the Offered Shares (or Pre-Funded Warrants in lieu thereof) sold.”). (2) Represents placement agent, legal and accounting fees and expenses and out-of-pocket costs (See “Plan of Distribution”). 38 39
The Offered Shares will begenerally freely transferable, subject to any restrictions imposed by applicable securities laws or regulations.
Listing of Offered Shares
The Offered Shares will belisted on The Nasdaq Capital Market under the symbol “TIVC.”
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Our authorized capital stockconsists of 200,000,000 shares of common stock, $0.0001 par value per share, and 10,000,000 shares of preferred stock, $0.0001 parvalue per share.
As of August 12, 2024, there are 6,183,592 sharesof common stock outstanding, and zero shares of preferred stock outstanding.
In addition, as of August 12, 2024, there were outstandingoptions to purchase 66,367 shares of our common stock and outstanding warrants to purchase 12,022,897 shares of our common stock outstanding.
This description is intended to be a summaryand is qualified in its entirety by reference to our Charter and Bylaws, which are filed as exhibits to this Offering Circular.
Common Stock
Voting Rights
Holders of our common stock are entitledto one vote for each share of common stock held of record for the election of our directors and all other matters requiring stockholderaction, except with respect to amendments to our Charter to alter or change the powers, preferences, rights or other terms of any outstandingpreferred stock if the holders of such affected series of preferred stock are entitled to vote on such an amendment. Holders of our commonstock do not have cumulative voting rights. In the case of election of directors, all matters to be voted on by our stockholders mustbe approved by a plurality of the votes entitled to be cast by all shares of common stock. Accordingly, the holders of a majority of theoutstanding shares of common stock entitled to vote in any election of directors can elect all of the directors standing for election,if they so choose, other than any directors that holders of any preferred stock we may issue may be entitled to elect. Except as otherwiseprovided by our Charter, Bylaws, the rules or regulations of any stock exchange applicable to the Company, or applicable law or pursuantto any regulation applicable to the Company or its securities, all other matters presented to our stockholders at a duly called or convenedmeeting, at which a quorum is present, shall be decided by the affirmative vote of the majority of shares present in person or representedby proxy at the meeting and entitled to vote on the subject matter.
Dividends
Dividends may be declared and paid onshares of our common stock as and when determined by our board of directors, subject to any preferential dividend or other rights of anythen outstanding preferred stock and to the requirements of applicable law. Subject to preferences that may apply to any shares of preferredstock outstanding at the time, the holders of our common stock will be entitled to share equally, identically and ratably in any dividendsthat our board of directors may determine to issue from time to time.
Liquidation Rights
In the event of any voluntary or involuntaryliquidation, dissolution or winding up of our affairs, holders of our common stock would be entitled to share ratably in our assets thatare legally available for distribution to stockholders after payment of our debts and other liabilities. If we have any preferred stockoutstanding at such time, holders of the preferred stock may be entitled to distribution and/or liquidation preferences. In either suchcase, we must pay the applicable distribution to the holders of our preferred stock before we may pay distributions to the holders ofour common stock.
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Other Rights
Our stockholders have no preemptive, conversionor other rights to subscribe for additional shares, and there are no redemption or sinking funds provisions applicable to the common stock.The rights, preferences and privileges of the holders of our common stock will be subject to, and may be adversely affected by, the rightsof the holders of shares of any series of our preferred stock that we may designate and issue in the future.
Preferred Stock
No series of preferred stock are currentlydesignated, and there are no shares of preferred stock currently outstanding. Under the terms of our Charter, our board of directors hasthe authority, without further action by our stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series,to establish from time to time the number of shares to be included in each such series, to fix the dividend, voting and other rights,preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon, andto increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding.
Our board of directors may authorize theissuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holdersof the common stock. The issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporatepurposes, could, among other things, have the effect of delaying, deferring or preventing a change in our control and may adversely affectthe market price of the common stock and the voting and other rights of the holders of common stock. We have no current plans to issueany shares of preferred stock.
Anti-Takeover Effects of DelawareLaw and Our Charter and Bylaws
Certain provisions of Delaware law, aswell as our Charter and Bylaws contain provisions that could have the effect of delaying, deferring or discouraging another party fromacquiring control of us. These provisions, which are summarized below, are expected to discourage certain types of coercive takeover practicesand inadequate takeover bids. These provisions are also designed, in part, to encourage persons seeking to acquire control of us to firstnegotiate with our Board. We believe that the benefits of increased protection of our potential ability to negotiate with an unfriendlyor unsolicited acquirer outweigh the disadvantages of discouraging such proposals, including proposals that are priced above the then-currentmarket value of our common stock, because, among other reasons, such negotiation could result in an improvement of the terms of such proposals.
Charter and Bylaws
Certain provisions set forth in our Charter,Bylaws, and in Delaware law, which are summarized below, may be deemed to have an anti-takeover effect and may delay, deter or preventa tender offer or takeover attempt that a stockholder might consider to be in its best interests, including attempts that might resultin a premium being paid over the market price for the shares held by stockholders.
Classified Board of Directors
Our Board is divided into three classesserving three-year terms, with one class being elected each year by a plurality of the votes cast by the stockholders entitled to voteon the election.
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Proposals of business and nominations.
Our Bylaws generally regulate proposalsof business and nominations for election of directors by stockholders. In general, Section 2.5 requires stockholders intending to submitproposals or nominations at a stockholders meeting to provide the Company with advance notice thereof, including information regardingthe stockholder proposing the business or nomination as well as information regarding the proposed business or nominee. Sections 2.4 and2.5 provides a time period during which business or nominations must be provided to the Company that will create a predictable windowfor the submission of such notices, eliminating the risk that the Company finds a meeting will be contested after printing its proxy materialsfor an uncontested election and providing the Company with a reasonable opportunity to respond to nominations and proposals by stockholders.
Blank Check Preferred Stock.
Our Board has the right to issue preferredstock in one or more series and to determine the designations, rights, preferences of such preferred stock without stockholder approval.
Board Vacancies.
Our Bylaws generally provide that onlyour Board (and not the stockholders) may fill vacancies and newly created directorships.
While the foregoing provisions of ourCharter, Bylaws and Delaware law may have an anti-takeover effect, these provisions are intended to enhance the likelihood of continuityand stability in the composition of the Board and in the policies formulated by the Board, and to discourage certain types of transactionsthat may involve an actual or threatened change of control. In that regard, these provisions are designed to reduce our vulnerabilityto an unsolicited acquisition proposal. The provisions also are intended to discourage certain tactics that may be used in proxy fights.However, such provisions could have the effect of discouraging others from making tender offers for our shares and, as a consequence,they also may inhibit fluctuations in the market price of our common stock that could result from actual or rumored takeover attempts.Such provisions also may have the effect of preventing changes in our management.
Delaware Anti-Takeover Statute
We are subject to the provisions of Section203 of the Delaware General Corporation Law (“Section 203”) regulating corporate takeovers. In general, Section 203 prohibitsa publicly-held Delaware corporation from engaging, under certain circumstances, in a business combination with an interested stockholderfor a period of three years following the date the person became an interested stockholder unless:
· | prior to the date of the transaction, the board of directors of the corporationapproved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder; | |
· | upon completion of the transaction that resulted in the stockholder becoming aninterested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time thetransaction commenced, excluding for purposes of determining the voting stock outstanding, the outstanding voting stock owned by the interestedstockholder, (i) shares owned by persons who are directors and also officers and (ii) shares owned by employee stock plans in which employeeparticipants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender orexchange offer; or | |
· | at or subsequent to the date of the transaction, the business combination is approvedby the board of directors of the corporation and authorized at an annual or special meeting of stockholders, and not by written consent,by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder. |
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Generally, a business combination includesa merger, asset, stock sale or other transaction resulting in a financial benefit to the interested stockholder. An interested stockholderis a person who, together with affiliates and associates, owns or, within three years prior to the determination of interested stockholderstatus, did own 15% or more of a corporation’s outstanding voting stock. We expect the existence of Section 203 to have an anti-takeover effect with respect to transactions our Board does not approve in advance. We also anticipate that Section 203 may discouragebusiness combinations or other attempts that might result in a premium over the market price for the shares of common stock held by ourstockholders.
Listing
Our common stock is listed on the NasdaqCapital Market under the ticker symbol “TIVC.”
Transfer Agent and Registrar
The transfer agent and registrar for our common stockis Equiniti Trust Company. The transfer agent’s principal business address is 90 Park Avenue, 25th Floor, New York, NY 10016, andits telephone number is 800-468-9716.
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DESCRIPTION OF SECURITIES WE ARE OFFERING
We are offering an aggregate of 6,666,667 shares of our common stock and/or Pre-Funded Warrants to purchase shares of our common stock. We are also registering the shares of common stock issuable from time to time upon exercise of the Pre-Funded Warrants offered hereby.
Common Stock
The material terms and provisions of our commonstock and each other class of our securities which qualifies or limits our common stock are described under the caption “Description of Capital Stock” in this Offering Circular.
Pre-FundedWarrants
The followingsummary of certain terms and provisions of the Pre-Funded Warrants that are being offered hereby is not complete and issubject to, and qualified in its entirety by, the provisions of the Pre-Funded Warrants, the form of which is filed as anexhibit to this Offering Circular. Prospective investors should carefully review the terms and provisions of the form ofPre-Funded Warrant for a complete description of the terms and conditions of the Pre-Funded Warrants.
Duration and Exercise Price
Each Pre-FundedWarrant offered hereby will have an initial exercise price equal to $0.0001 per share of common stock.ThePre-FundedWarrants will be exercisable immediately, and may be exercised at any time untilthePre-FundedWarrants are exercised in full. The exercise price and number of shares of common stock issuable uponexercise is subject to appropriate proportional adjustment in the event of share dividends, share splits, reorganizations or similarevents affecting shares of our common stock and the exercise price.
Exercisability
ThePre-FundedWarrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise noticeand within the earlier of (i) two trading days and (ii)the number of trading days comprising the standard settlementperiod with respect to the shares of common stock as in effect on the date of delivery of the notice of exercise thereafter, paymentin full for the number of shares of common stock purchased upon such exercise (except in the case of a cashless exercise asdiscussed below). A holder may not exercise any portion of thePre-FundedWarrant to the extent that the holder, togetherwith its affiliates and any other persons acting as group together with any such persons, would own more than 4.99% (or, at theelection of the purchaser, 9.99%) of the number of shares of our common stock outstanding immediately after exercise (the“Beneficial Ownership Limitation”); provided that a holder with Beneficial Ownership Limitation of 4.99%, upon notice touse and effective 61 days after the date such notice is delivered to us may increase the Beneficial Ownership Limitation so long asit in no event exceeds 9.99% of the number of ordinary shares outstanding immediately after exercise.
Cashless Exercise
ThePre-Funded Warrants may also be exercised, in whole or in part, at any time by means of “cashless exercise” inwhich the holder shall be entitled to receive upon such exercise (either in whole or in part) the net number of shares of commonstock determined according to a formula set forth in the Pre-Funded Warrants, which generally provides for a number of shares ofcommon stock equal to (A)(1) the volume weighted average price on (x) the trading day preceding the notice of exercise, if thenotice of exercise is executed and delivered on d ay that is not a trading day or prior to the opening of “regular tradinghours” on a trading day or (y)the trading day of the notice of exercise, if the notice of exercise is executed anddelivered after the close of “regular trading hours” on such trading day, or (2)the bid price on the day of thenotice of exercise, if the notice of exercise is executed during “regular trading hours” on a trading day and isdelivered within two hours thereafter, less (B)the exercise price, multiplied by (C)the number of shares of common stockthe Pre-Funded Warrant was exercisable into, with such product then divided by the number determined under clause (A)in thissentence.
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Fractional Shares
No fractional shares of common stock will beissued upon the exercise of thePre-FundedWarrants. Rather, we will, at our election, either pay a cash adjustment in respectof such final fraction in an amount equal to such fraction multiplied by the exercise price or round up to the next whole shares of commonstock.
Transferability
Subject to applicable laws, aPre-FundedWarrantmay be transferred at the option of the holder upon surrender of thePre-FundedWarrant to us together with the appropriateinstruments of transfer and funds sufficient to pay any transfer taxes payable upon such transfer.
Trading Market
There is no trading market available for thePre-FundedWarrantson any securities exchange or nationally recognized trading system. We do not intend to list thePre-FundedWarrants on anysecurities exchange or nationally recognized trading system. The shares of common stock issuable upon exercise of thePre-FundedWarrantsare currently listed on The Nasdaq Capital Market under the symbol “TIVC.”
Rights as a Shareholder
Except as otherwise provided in thePre-FundedWarrantsor by virtue of such holder’s ownership of the underlying shares of common stock, the holders of thePre-FundedWarrantsdo not have the rights or privileges of holders of shares of our common stock, including any voting rights, until they exercise theirPre-FundedWarrants.
Fundamental Transaction
In the event of a fundamental transaction, asdescribed in thePre-FundedWarrants and generally including any reorganization, recapitalization or reclassification of ourshares of common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets, our consolidationor merger with or into another person, the acquisition of more than 50% of our outstanding shares of our common stock, the holders ofthePre-FundedWarrants will be entitled to receive upon exercise of thePre-FundedWarrants the kind and amount ofsecurities, cash or other property that the holders would have received had they exercised thePre-FundedWarrants immediatelyprior to such fundamental transaction.
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Business Overview
Tivic Health is a health tech companyfocused on bioelectronic medicine. Bioelectronic medicine is a branch of the global neuromodulation market that treats disease and conditionsby modulating the electrical signals carried along various nerve pathways. The field grew out of the neuromodulation industry and relied,historically, on implantable devices (e.g., pacemakers, spinal implants, deep brain stimulators). IDTechEx has identified several fast-growingareas in the bioelectronic medicine field, including peripheral nerve stimulation, which it has indicated is forecasted to grow at a 35%CAGR from 2019 through 2029. Tivic currently has two non-invasive bioelectronic platforms designed to deliver therapeutic benefits viamanipulation of such signals without the use of traditional implanted technology.
Platforms
Tivic has developed two complementaryplatforms. Tivic’s first commercial platform is a handheld design that interfaces non-invasively with the trigeminal, sympathetic,and other facial and cranial nerve structures. This platform is the basis for Tivic’s existing product, currently marketed withFDA approval as ClearUP Sinus Pain Relief for the treatment of sinus pain and congestion.
The second platform is a research-stageplatform directed to vagus nerve stimulation, which is currently undergoing clinical evaluation. We received the final data analysis forour pilot clinical study with The Feinstein Institutes for Medical Research in the beginning of May 2024, and the final data analysisresults were publicly announced by the Company on May 8, 2024. See the section of this Offering Circular entitled “Recent Developments,”below, for additional information regarding the final data results.
First Commercial Product
Tivic Health currently markets one commercialproduct under the brand name “ClearUP Sinus Pain Relief.” ClearUP is built on our patented, handheld neuromodulation designand was developed by Tivic Health for the treatment of sinus and allergy-related conditions. It uses ultra-low current electrical wavesto relieve sinus pain and congestion symptoms that are prevalent in nasal allergies, sinus infections, chronic sinusitus, cold and fluand other disease conditions. ClearUP had U.S. FDA approval for the treatment of sinus pain and congestion, and is the first FDA-approvedbioelectronic treatment of the foregoing indications. Additionally, ClearUP has E.U. CE Mark approval for the treatment of sinus pain,pressure and congestion.
The FDA initially provided clearanceto our ClearUP product under a 510(k) as an allergy treatment in January
2019. The FDA granted ClearUP a subsequentDe Novo clearance in March 2021, which expanded ClearUP’s label, enabling marketing of ClearUP for allergies, sinusitis, cold, flu,and any inflammatory condition involving congestion.
A 2023 study with over 2,000 representativeconsumers conducted by Intellego Insights (commissioned by Tivic Health) identified that approximately 85 million U.S. adults experienceinflammation-related symptoms related to allergies, congestion, head pain, and sinus issues. Of the consumers that participated in thestudy, 58% of sufferers try to avoid medication, if at all possible.
Customers can purchase ClearUP productsdirectly from Tivic via our own website and through major online stores, including Amazon, Walmart, BestBuy, FSAStore and HSA Store. TheCompany has also entered distribution agreements with McKesson, Cardinal Health and Amerisource Bergen.
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A sham-controlled clinical trial is inprogress with the Icahn School of Medicine at Mount Sinai, to extend the use of Tivic’s handheld monopolar platform to the managementof pain resulting from functional endoscopic sinus surgery and other facial surgeries. If successful, the Company may develop additionalproducts addressing this clinical use case, which would require new regulatory clearances for a novel indication.
We have also previously evaluatedthe market opportunity for use of ClearUP as part of a migraine treatment toolkit. While we believe that both clinical and market rationaleare positive for such use, we have, for the time being, determined to down-prioritize any clinical studies of migraine-related indicationsbased on the aggressive competition among entrenched incumbents and limited uptake, to date, of existing devices for the treatment and/or prevention of migraine.
Expanding Our Technology Portfolio
Tivic has also developed a proprietarynon-invasive approach to precision vagus nerve stimulation (“VNS”) based on our experience building evidence-based bioelectronictherapies. The vagus nerve is the tenth cranial nerve and the longest autonomic nerve in the body. The vagus nerve is responsible forregulating several bodily functions including digestion, heart rate, breathing, cardiovascular activity, and visceral reflexes. Sincethe vagus nerve regulates many organ systems associated with chronic disease, modulating activity in this nerve pathway is of significantinterest in academic research and in industry.
Electrical VNS is currently indicatedfor treatment-resistant epilepsy and depression, cluster headache, migraine headache, and stroke rehabilitation and is being studied forother neurological, cardiac, and immune conditions. Currently, there are both invasive implantable VNS devices and non-invasive VNS devicesin market. There is room for meaningful improvement in how VNS devices can be used to more precisely target and stimulate the vagus nerveto achieve intended biological and clinical outcomes.
Our approach to non-invasive VNS aimsto leverage improvements in engineering, circuitry, and stimulation parameters to augment efficacy and reliability compared to the currentstate of the art. We have conducted proof of principle experiments demonstrating effects on the autonomic nervous system and have initiateda clinical research program with The Feinstein Institute for the Bioelectronic Medicine at Northwell Health to further characterize theautonomic, cardiovascular, and neurological effects of our intervention.
Given our deep expertise and relationshipsin the field of bioelectronic medicine and adjacent diagnostic fields, we are continuously monitoring and evaluating options to add complementaryproduct opportunities into our product portfolio.
ALOM Agreement Termination
Effective August 1, 2024, we terminated theFulfillment Services Agreement with ALOM Technologies Corporation (“ALOM”) on November 25, 2022, as amended on March 5, 2024(the “ALOM Agreement”), pursuant to which ALOM provided, on a non-exclusive basis, certain assembly, procurement, storage, returns,and fulfillment services (collectively, the “Services”) to our end customers and retailers within the United States. Weterminated the ALOM Agreement for convenience, in accordance with the terms of the ALOM Agreement, in furtherance of our efforts to continueto reduce both direct and indirect costs associated with product manufacturing and distribution. We did not incur any material early terminationpenalties in connection with the termination of the ALOM Agreement. We are now utilizing third-party logistics and storage services fromalternate suppliers without material minimums and have established in-house assembly and testing capabilities. We completed the transitionwith no disruptions to service and foresees current capacity will be sufficient to meet demand for the foreseeable future.
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Business Updates
May 2024 Public Offering
On May 13, 2024, we sold an aggregate of (i) 4,710,000shares of common stock, (ii) Series A warrants to purchase up to 4,710,000 shares of common stock and (iii) Series B warrants to purchaseup to 7,065,000 shares of common stock to certain investors in a registered public offering at a combined public offering price of $0.85per share and accompanying warrants. We also issued Maxim Group LLC, who served as the placement agent for the offering, warrants to purchase188,400 shares of common stock as partial compensation for services rendered in connection with the offering. The securities were registeredpursuant to the registration statement on Form S-1 (File No. 333-278383), which was initially filed with the Securities and Exchange Commission(the “SEC”) on March 29, 2024, and amended on April 29, 2024 and May 8, 2024, and declared effective on May 9, 2024.
We received gross proceeds from the offering of approximately$4.0 million, before deducting placement agent fees and other estimated offering expenses payable by the Company. Net proceeds to theCompany from the Offering, after deducting the placement agent fees and expenses and estimated offering expenses (excluding proceeds tothe Company, if any, from the future exercise of the warrant issued in connection with the offering), were approximately $3.5 million.See Note 13 to our condensed financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q for additional informationregarding this offering.
VNS Clinical Research
On May 8, 2024, we announced the final results of our pilot research study with The Feinstein Institutes for Medical Research. Through this collaboration, we have confirmed the effectiveness of our patent-pending non-invasive cervical vagus nerve stimulation (“ncVNS”) approach, which induces responses in the autonomic, cardiac, and central nervous systems and can be expected to have clinical utility in several major disease areas.
· | Compared to baseline measurement, our ncVNS intervention resulted in a 97% increase in the root mean squareof successive differences (“RMSSD”) measure of heart rate variability, which is a widely accepted proxy for vagus nerve activity. | |
· | Measurements of brain activity using EEG demonstrated that our ncVNS intervention increased frontal thetapower by 24% and reduced gamma power in several brain regions, including a 66% reduction in frontal gamma power. These changes in brainactivity are consistent with reduced arousal and anxiety. | |
· | During ncVNS stimulation, subjects had sustained pupil constriction, a 9.5% reduction in pupil diameter,an outcome associated with activation of the parasympathetic nervous system. |
Previous studies of non-invasive VNS devices havereported mixed results regarding autonomic nervous system changes. The magnitude of our ncVNS data imply potential for greater clinicaleffects and enhanced reproducibility. While these results were in healthy subjects, the data suggest our ncVNS approach may have clinicalutility in several patient populations including those with epilepsy, post-traumatic stress disorder, and ischemic stroke, among others.
On May 17, 2024, we entered into a Collaboration andResearch Support Agreement with The Feinstein Institutes for Medical Research, pursuant to which we will collaborate with The FeinsteinInstitutes for Medical Research in the development and drafting of a protocol (the “Protocol”) to advance a research programdesigned to test Autonomic Nervous System (“ANS”) function and/or balance in healthy able-bodied individuals in response toneuromodulation of the ANS by our neurostimulation device, by leveraging and augmenting the NDS Lab’s multi-modal index to quantifythe activation status of the ANS during various of clinically relevant tests, and to submit such Protocol and the research study describedtherein (the “Study”) for institutional and IRB approval. If the Protocol and Study are approved, the Study shall be implementedpursuant to the Protocol and shall be governed by the terms of the agreement. Total length of the project is expected to be one year.
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Pursuant to the agreement, we shall be responsiblefor participant reimbursement and the full time equivalents involved in acquiring IRB approval, recruiting and performing the experiments,and analyzing all the data and development of all algorithms, as more particularly set forth in the Agreement. Payments will be made bythe Company upon completion of the following milestones:
· | MILESTONE 1: Execute Collaboration and Research Support Agreement - $24,485.60 | |
· | MILESTONE 2: Receive IRB study approval - $48,971.20 | |
· | MILESTONE 3: Complete enrollment of first all participants and run 1/3 sessions - $85,699.60 | |
· | MILESTONE 4a/b: Complete all sessions; submit final report - $85,699.60 |
Lease Termination
On May 21, 2024, we entered into a Sublease TerminationAgreement (the “Termination Agreement”) with Czarnowski Display Service, Inc. (“CDS”), pursuant to which we terminatedthat certain Sublease Agreement, by and between the Company and CDS, dated as of November 17, 2021 (the “Sublease”), effectiveas of May 31, 2024 (the “Termination Date”). Prior to the Termination Date, we leased approximately 9,091 square feet of officespace located at 25821 Industrial Boulevard, Suite 100, Hayward, California (the “Premises”) under the Sublease, which servedas our principal place of business.
In exchange for the early termination of the Subleasepursuant to the Termination Agreement, we made a one-time termination payment to CDS in the amount of $44,480.44. Additionally, in connectionwith the termination, we agreed to pay (i) all commissions owned to any broker in connection with the sublease of the Premises by CDSto the new sublessee, and (ii) any fees or expenses charged by the owner of the Premises in connection with its review of the new subleaseagreement with the new sublessee.
We expect that the termination of the Sublease willresult in a reduction of approximately $200,000 in lease expense over the next year and a half.
New Principal Place of Business
On May 30, 2024, we entered into a Co-Working SpaceAgreement, pursuant to which we rent office space located at 47685 Lakeview Blvd., Fremont, California, which will serve as our principalplace of business, for a total $1,000 a month. The agreement has an initial term of six months, commencing June 1, 2024, after which itwill automatically renew on a month to month basis until terminated.
Appointment of Christina Valauri to the Board
On June 17, 2024, our board of directors (the “Board”)appointed Christina Valauri as a director of the Company, effective July 1, 2024, to fill a vacancy in the Class I class of directorsof the Board. Additionally, Ms. Valauri was appointed to serve as a member of the Compensation Committee, Audit and Risk Committee andNominations and Corporate Governance Committee of the Board, and replaced Karen Drexler as chairperson of the Nominations and CorporateGovernance Committee, in each case effective July 1, 2024. Ms. Drexler continues to serve as a member of the Nominations and CorporateGovernance Committee.
Resignation of Karen Drexler from the Board
On June 17, 2024, Karen Drexler tendered her resignationfrom the Board and each of the Compensation Committee, Audit and Risk Committee and Nominations and Corporate Governance Committee thereof,in each case effective September 30, 2024. Ms. Drexler’s decision to resign from her positions as a director on the Company’sBoard was not the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or practices,and it is expected that Ms. Drexler will continue to serve as an advisor to the Company and the Board after her resignation is effective.
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Nasdaq Compliance
On June 28,2024, we received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”)notifying us that, because the closing bid price for our common stock was below $1.00 per share for 33 consecutive business days, we arenot currently in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth inNasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The notification had no immediate effect on thelisting of our common stock on the Nasdaq Capital Market, and, therefore, our listing remains fully effective.
In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A),we have a period of 180 calendar days from June 27, 2024, or until December 26, 2024, to regain compliance with the Minimum Bid PriceRequirement. If at any time before December 26, 2024, the closing bid price of our common stock closes at or above $1.00 per share fora minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the MinimumBid Price Requirement, and the matter would be resolved. If we do not regain compliance during the compliance period ending on December26, 2024, then Nasdaq may grant us a second 180 calendar day grace period to regain compliance, provided we (i) meet the continued listingrequirement for market value of publicly-held shares and all other initial listing standards for the Nasdaq Capital Market, other thanthe minimum closing bid price requirement, and (ii) we notify Nasdaq of our intent to cure the deficiency.
We intend to continue actively monitoringthe closing bid price for our common stock between now and December 26, 2024, and will consider available options to resolve the deficiencyand regain compliance with the Minimum Bid Price Requirement. If we do not regain compliance within the allotted compliance period, includingany extensions that may be granted by Nasdaq, Nasdaq will provide notice that our common stock will be subject to delisting. We wouldthen be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance withthe Minimum Bid Price Requirement during the 180 day compliance period, secure a second period of 180 calendar days to regain compliance,or maintain compliance with the other Nasdaq listing requirements.
Market Opportunity
In December 2021, Precedence Researchnoted that the burden of various chronic diseases and infections is growing and so have people’s healthcare expenditures. In 2018,the per capita healthcare expenditure in the U.S. was over $10,500. U.S. health care spending grew 4.1 percent in 2022, reaching $4.5trillion, or $13,493 per person.
Grand View Research projects that thenon-invasive electroceutical devices segment will witness the highest growth through 2030. This is due to technological advancements andrising investments in research and development by companies for innovative product development.
Additionally, according to Mintel GroupLtd., over-the-counter allergy, cough, cold and flu treatments were projected to be an $11.1 billion market by 2025 in the U.S. alone.
The FDA provided clearance to our ClearUPproduct under a 510(k) for the temporary relief of sinus pain associated with allergic rhinitis in January 2019. As a treatment for allergy-relatedsinus pain, we believe that the available market for ClearUP is approximately 45 million U.S. adults.
The FDA then granted ClearUP a subsequentDe Novo clearance in March 2021 for the temporary relief of moderate to severe congestion, expanding ClearUP’s label and enablingmarketing of ClearUP for allergies, sinusitis, cold, flu, and any inflammatory condition involving congestion. As a treatment for moderateto severe congestion, we believe the available target market for ClearUP is approximately 85 million U.S. adults.
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We have also received a CE Mark for internationalmarketing of ClearUP. The CE Mark for ClearUP covers a broad set of conditions related to sinonasal inflammation with the symptoms pain,pressure and congestion. The CE Mark allows sales in European Union Member states and certain other countries that recognize the CE Markfor regulatory governance. We believe that there are international opportunities for the sale of ClearUP.
In clinical research studies pertainingto ClearUP:
· | 82% of participants indicated that they prefer it to their current treatments;(1) and | |
· | 77% of participants indicated that they would recommend ClearUP.(2) |
(1) Data from a 71-person randomized controlled study conducted by a third-party academic research center.
(2) Data from a 30-person open label trial conducted by a third-party clinical research organization.
In 2023, we completed, with IntellegoIntelligence, a 2000-person market segmentation study that identified the following addressable markets in the United States, based onthe Company’s current pricing structure for ClearUP:
· | Individuals with severe sinus conditions representing a $0.9 billion addressable market, of which the Company has achieved less than0.002% penetration. | |
· | Allergy sufferers seeking to avoid pharmaceutical side effects, representing $1.2 billion addressablemarket, of which the Company has achieved less than 0.002% penetration. | |
· | High-performance athletes seeking improved breathing to enhance performance, representing a $2.4 billion addressable market that theCompany has not yet targeted. | |
· | CPAP and Sleep Apnea sufferers for whom congestion is a significant contributing factor to lack of qualitysleep and/or CPAP compliance, representing a $0.6 billion addressable market. | |
· | Individuals for whom sinus conditions cascade into severe headaches and migraine, representing a $4.0 billion addressable market.Claims for migraine would require separate FDA submissions beyond the Company’s currently approved indications. |
Sales and Marketing
ClearUP is sold directly to consumersthrough our own website, Amazon, and Walmart. We also sell to major online retailers, such as BestBuy and FSAStore. In 2023, we also enteredinto distribution agreements with Cardinal Health and AmerisourceBergen, and subsequently, in 2024, established a relationship with McKesson-affiliate Simply Medical. Expansion of our ClearUP sales channels has been gradual and measured to maintain pricing integrity, cultivateconsumer acceptance and establish strong channel relationships.
Our marketing strategy is built aroundcustomer segments, whose buying decisions may be driven by differentiated messages. We reach and convert our customers for ClearUP througha combination of press releases, advertising, retargeting and emails.
In Q4 of 2023, we also partnered withIn-Step on a trial physician education program, reaching 2,500 physicians over four months with information about bioelectronic medicine,the clinical efficacy of ClearUP, and patient education materials.
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Core Technology
Our technology combines proprietary algorithms,programmable stimulation parameters, and a patented delivery mechanisms to modulate nerve signals. We are researching the utility of thisstimulation approach for other clinical conditions.
Tivic currently has two non-invasive bioelectronicplatforms designed to deliver therapeutic benefits via manipulation of such signals without the use of traditional implanted technology,one of which has been commercialized to date.
Key elements of our current commercialplatform include:
· | a proprietary algorithmic means of detecting areas of dense nerve innervation andblood vessels, which help guide a user to the optimal treatment locations; | |
· | a proprietary algorithmic means of adapting treatment currents and detection tothe unique physiological attributes of the technology’s user at the time of use; | |
· | a proprietary algorithmic means of dynamically adjusting treatment levels to maintainboth efficacy and comfort; | |
· | programmability of the stimulation protocols via firmware to deliver varied stimulationprotocols for different physical and disease targets, providing accelerated opportunities for new product applications; and | |
· | a unique monopolar design that enables ultra-low currents to pass through skin andtissue while maintaining nearly imperceptible current levels. |
This combination creates a platformfor non-invasively influencing peripheral activity in the facial region with an ultra-low current level.
Numerous inflammatory conditions are associatedwith trigeminal and peripheral nerve activity of the face, including:
· | chronic quality-of-life conditions such as migraines (39 million U.S.), temporomandibularjoint disorder (31 million U.S.), and tinnitus (50 million U.S.); | |
· | severe, life-altering conditionssuch as trigeminal neuralgia (150,000 U.S., severe condition); and | |
· | acute conditions such as ear infections (50% of children) and pain and swellingfrom facial and sinus surgeries (600,000 functional endoscopic surgeries annually, U.S.). |
Each of these applications wouldinvolve regulation of pain and inflammation-related mediators like those seen in sinus and nasal inflammation.
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Our second platform is a research-stage platform directedto vagus nerve stimulation, which is currently undergoing clinical evaluation in partnership with The Feinstein Institutes for MedicalResearch. Multiple acute and chronic conditions could be the target for our non-invasive vagus nerve treatment platform, including:
· | acute and chronic inflammation (e.g. sepsis, brain injury, major depressive disorder); | |
· | auto-immune inflammation (e.g. rheumatoid arthritis, Crohn’s disease); and | |
· | autonomic nervous system dysfunction (e.g. dysautonomia, post-traumatic stress disorder). |
We believe that this non-invasive, low-risknature of Tivic’s approach to bioelectronic medicine has the potential to accelerate new product development by: (i) extending thedevice platforms to other clinical areas, thereby reducing research and development time, and (ii) continuing to benefit from low-risknon-invasive device designations and regulatory pathways by the FDA, which typically result in shorter time to approval when comparedwith invasive devices or new drugs. Although it is our intention to bring new products to market, medical device development is inherentlyuncertain and there is no guarantee that our research and development efforts will lead to approved products for other clinical indications.
Competitive Landscape
Pharmaceutical Treatments
Sinus pain, pressure and congestion canbe caused by allergic rhinitis (allergies), rhinosinusitis, sinus infections, cold and flu and are most often treated with over-the-counterproducts targeted symptomatically.
· | Sinus pain/pressure is usually managed with analgesic medications (e.g., ibuprofen/Advil,acetaminophen/Tylenol, naproxen sodium/Aleve). Analgesic medications provide short periods of relief and are often associated with sideeffects including stomach pain, bleeding, ulcers, constipation, diarrhea, gas, bloating, heartburn, nausea, vomiting, dizziness, headache,nervousness, and rash. | |
· | Congestion is treated with a variety of approaches: |
· | Antihistamine medications are often a first-line therapy for allergy-relatedsymptoms and research indicates that they are effective for treating allergy symptoms such as itchiness, but are less effective for congestion.Antihistamine medications (e.g., loratadine/Claritin) are generally well-tolerated, but may have side-effects including headache, sleepiness,fatigue, dry mouth, and sore throat. | |
· | Oral decongestants (e.g., phenylephrine/Sudafed) used to treat congestionhave been demonstrated to exert poor to moderate efficacy, and are associated with nervousness, restlessness, insomnia, dizziness, tachycardia,heart palpitations, syncope, headache, sweating, nausea or vomiting, trembling, paleness, and weakness. | |
· | Intranasal decongestants (e.g., oxymetazoline/Afrin) are more effective than oral decongestants. However, they have reduced effectiveness and rebound effects after three days of use and can lead to the development of a serious condition, rhinitis medicamentosa. Additionally, intranasal decongestants cause side effects including nose irritation or burning, sneezing, dizziness, increased blood pressure, tachycardia, heart palpitations, restlessness and insomnia | |
· | Intranasal glucocorticoids (e.g., fluticasone propionate/Flonase) have beenshown to have the most significant benefits, with some studies showing a 34% reduction in congestion severity after one week of use. Intranasalglucocorticoids have several side effects including epistaxis, dryness, stinging, burning in nose, headache, nausea, vomiting, diarrhea,dizziness, sore throat, and cough. |
Examples of companies developingdrugs for pain and congestion include GlaxoSmithKline, Bayer, and Johnson & Johnson.
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Limitations on Use of PharmaceuticalTreatments
Due to the side effect profiles of pharmaceuticals,many of the above-mentioned treatments carry warnings to discontinue use after two weeks or less according to the U.S. National Libraryof Medicine. Additionally, some carry warnings regarding use with certain medications or diseases such as high blood pressure.
In the Fall of 2023, a panel of U.S. healthexperts found that many widely used products containing phenylephrine are ineffective. According to a Yale School of Medicine news article,an FDA advisory committee unanimously concluded that phenylephrine, an ingredient found in popular nasal decongestants sold under suchbrand names as Sudafed and Dayquil, works no better than a placebo in treating cold and allergy symptoms.
Non-pharmaceutical Treatments
According to our 2023 Intellego Insightstudy, many consumers are seeking natural, non-pharmaceutical treatment options. Alternative options currently include, without limitation:
· | Nasal irrigation with saline, rinsing the nasal passages with saline solutionis a common non-pharmaceutical treatment. Example products include NeilMed Sinus Rinse, Navage Nasal Care and Vicks Sinex Severe. Nasalirrigation is understudied, but there is some evidence of improved quality of life and clearance of mucus. However, saline can irritatean already inflamed sinonasal tissue and nasal irrigation using tap water has been found to carry risk of parasite-driven encephalitis. | |
· | Bioelectronic devices. ClearUP is the first device to have been approvedby the FDA under a de novo classification for the intended use for temporary relief of moderate to severe congestion. The Company alsoreceived FDA clearance for the intended use in treatment of sinus pain associated with allergic rhinitis. |
Examples of companies developing non-drugproducts for sinus pain and congestion include NeilMed, Rhinosystems Inc., and Vapore LLC.
ClearUP is a novel product offering inthe non-drug category, an emerging bioelectronic medicine segment, and currently has small market share compared to the existing establishments,most of which offer pharmaceutical options.
Clinical Research on ClearUP
Allergic rhinitis is an inflammatory diseasedriven by IgE-mediated reactions to inhaled indoor or seasonal outdoor allergens. The resulting sinus and nasal inflammation may causesymptoms including sinus pain and pressure, nasal congestion, runny nose, sneezing, and nasal itching. Allergic rhinitis affects a significantnumber of U.S. adults, of which a vast majority experience sinus pain, pressure and congestion as a result of inflammation of the nasaland sinus mucosa.
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Key Technical Features
· | Treatment Point Detection. ClearUP employs an advanced treatmentpoint detection algorithm that dynamically personalizes to each user. Haptic vibration indicates to the user to hold the device over thesepoints to facilitate stimulation in areas that maximize therapeutic benefit. We have innovated by integrating dynamic measurement withneuromodulation technology to create this novel therapy. (Issued patents: US10625076, US11160978, and US10537738) | |
· | Monopolar Circuit. ClearUP delivers microcurrent stimulation via amonopolar circuit in which the rounded tip of the device is the active electrode and the conductive housing of the device serves as thereturn electrode. The monopolar design of ClearUP is a significant improvement over typical bipolar approaches to neuromodulation engineeringand facilitates deeper delivery of current and sensitive treatment point detection. (Issued patents: US10625076, US11160978, and US10596374) | |
· | Proprietary Waveform Delivery. ClearUP delivers a specific frequency,waveform shape, and amplitude of microcurrent that was empirically determined to have fast-acting therapeutic effects on users with commonsinonasal symptoms like pain and congestion. Additionally, we have developed an adaptive algorithm that ensures consistent and comfortabledelivery of microcurrent treatment on different parts of the face that can have varying electrical properties. (Issued patents: US10625076,US11160978, and US10537738) | |
· | Ergonomic Design and Ease of Use. ClearUP’s design ensures theproduct is comfortable to hold and that the hand will always be in contact with the conductive housing of the monopolar circuit. The deviceshape has also been refined so that the user can navigate the treatment path with ease. Additionally, the single-button control and intuitiveindicators make ClearUP Sinus Relief simple to use. Greater than 95% of users report that applying ClearUP Sinus Relief treatment is easy.(Issued patents: US10596374, US10576280) |
Two separate clinical trials have demonstratedthe safety and efficacy of ClearUP Sinus Relief in treating sinus pain from allergic rhinitis and moderate to severe congestion.
Pivotal Study: randomized, placebo-controlled,double-blinded clinical trial
In July 2018, the Stanford UniversitySinus Center conducted a double-blind randomized controlled clinical trial using the ClearUP bioelectronic device. 71 subjects sufferingfrom sinus pain and congestion used either ClearUP or a sham device. The sham device was identical to ClearUP in every way except thatit used a continuous DC output instead of the pulsed AC stimulation used by ClearUP.
Each subject used the real or sham devicefor a single five-minute treatment. Before and ten minutes after treatment, subjects completed questionnaires to quantify their symptoms.Subjects treated with ClearUP reported a rapid and clinically meaningful reduction in sinus pain (-29.6%) and congestion (-35%) at tenminutes after treatment.
This magnitude of change was significantlygreater than that observed in sham device-treated subjects.
PUBLICATION: Maul, X. A., Borchard,N. A., Hwang, P. H., & Nayak, J. V. (2019, April). Microcurrent technology for rapid relief of sinus pain: a randomized, placebo-controlled,double-blinded clinical trial. In International forum of allergy & rhinology (Vol. 9, No. 4, pp. 352-356).
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Open-label Prospective Trial
The Allergy and Asthma Associates of SantaClara Valley Research Center conducted a 30-person study on the use of ClearUP over four weeks. Subjects with sinus pain and congestionused the ClearUP device for five minutes during the study visit and then took the device home with them with instructions to use the deviceone to four times daily for five minutes per treatment as needed for four weeks. Subjects rated their symptoms weekly using a questionnaire.After the first five-minute treatment with ClearUP, subjects reported reduced sinus pain that remained six hours later, the longest timeinterval tested in the study. Additionally, subjects reported that after four weeks of use, they experienced an average of 43% reductionin sinus pain and 44% reduction in congestion. This magnitude of change was equivalent to efficacy seen in studies of fluticasone propionateafter two-weeks of use.
PUBLICATION: Goldsobel, A. B.,Prabhakar, N., & Gurfein, B. T. (2019). Prospective trial examining safety and efficacy of microcurrent stimulation for the treatmentof sinus pain and congestion. Bioelectronic medicine,
5(1), 1-9.
Safety
In the clinical studies and post-marketsurveillance, there have been no reports of any significant side effects and very few reports of minor side effects. Minor side effectshave included reddening of skin (<0.02%), eyelid twitch (<0.01%), and headache (<0.01%), all of which resolved without intervention.
VNS Clinical Research
The ANS maintains and coordinates thephysiology of multiple organs and organ systems in the human body, including the heart, lungs, intestines, and spleen, with additionalregulation of blood vessels and pupils. One particularly essential nerve in the ANS is the vagus nerve (“VN”). The afferentand efferent signals along the VN control reflexes of physiological homeostasis, including those in the cardiovascular, pulmonary, andgastrointestinal systems. Implanted VNS has been proven to be effective in treating epilepsy, treating depression, and supporting rehabilitationduring stroke recovery; however there is significant interest in non-invasive strategies to stimulate this neural pathway.
The Feinstein Institutes for Medical ResearchPhase I Study
In collaboration with the Zanos Laboratory at TheFeinstein Institutes for Medical Research, we conducted a clinical study to determine how our ncVNS intervention affects ANS, cardiac,and brain function. The 20-person clinical trial was led by Theodoros Zanos, Ph.D., Associate Professor in the Institute of BioelectronicMedicine and Head of the Neural and Data Science Lab at The Feinstein Institutes for Medical Research, twenty healthy subjects were recruitedand treated with ncVNS for twenty minutes and several physiologic measurements were taken before, during and after the treatment protocolto assess the impact of Tivic’s system on the autonomic nervous system, cardiac function, and brain activity.
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The study confirmed that our patent-pendingncVNS approach induced large, clinically relevant responses in the autonomic, cardiac, and central nervous systems and may have clinicalutility in several major disease areas. Study subjects exhibited a sustained reduction in pupil diameter during ncVNS, which is consistentwith increased vagal tone and parasympathetic activation. ANS activity was also measured via electrocardiogram and RMSSD, a widely usedmeasure of heart rate variability that is used as a proxy for vagus nerve activity. Compared with before ncVNS, after treatment subjectshad a 97% increase in RMSSD, which is indicative of an increased parasympathetic state. Additionally, we saw a 170% increase in RMSSDin high responders (2.7x), representing 60% of participants.
RMSSD is an accepted proxy for vagaltone and parasympathetic activity. Increasing parasympathetic activity may treat or prevent cardiac arrythmia, and higher RMSSD is associatedwith lower morbidity and mortality in cardiovascular disease. The cardiac data suggest potential applications in arrythmias and cardiovasculardisease.
Lastly, electroencephalography was appliedbefore and after ncVNS to measure brain activity. Subjects had a mean 24% increase in frontal theta activity, which is indicative of calmawake states, and a > 60% reduction in gamma activity in several brain regions, including the temporal and frontal lobes.
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Increased frontal theta activity is expectedto be useful in treating anxiety, post-traumatic stress disorder and other psychiatric disorders. Additionally, reducing gamma activityis an accepted therapeutic strategy for reducing the frequency of epileptic seizures. The brain data suggest ncVNS may have potentialapplications in neurology and psychiatry.
The magnitude of these changes seen inour ncVNS study suggest our ncVNS approach may have clinical utility in several patient populations including those with epilepsy, depression,post-traumatic stress disorder and ischemic stroke, among others.
Based on these promising data results, we believethat there may be significant potential for our platform in the noninvasive VNS space. We are working with The Feinstein Institutes forMedical Research to carry out the next phase of research for our clinical program, an optimization study program to further refine thetreatment parameters to address discrete disease targets. Additional clinical studies will be required to secure regulatory clearanceand Tivic Health’s VNS approach is currently for investigational use only.
Research Initiatives: New ProductCandidates
We combine proprietary algorithms,programmable stimulation parameters, and a patented monopolar delivery mechanism to modulate the nerve signals that control inflammation-drivensymptoms like pain and congestion. This design has proven effective in treating sinus and nasal inflammatory conditions and we are researchingthe clinical utility of this stimulation approach for other clinical conditions. This platform has the potential to accelerate new productdevelopment by: (i) extending the existing device platform to other clinical areas, thereby reducing research and development time, and(ii) continuing to benefit from low-risk, non-invasive device designations and regulatory pathways by the FDA, which typically resultin shorter time to approval when compared with invasive devices or new drugs.
Numerous inflammatory conditionsare associated with peripheral nerve activity of the face, including:
· | chronic quality-of-life conditions such as migraines (39 million U.S.), temporomandibular joint disorder(31 million U.S.), and tinnitus (50 million U.S.); | |
· | severe, life-altering conditions such as trigeminalneuralgia (150,000 U.S., severe condition); and | |
· | acute conditions such as ear infections (50% of children) and pain and swelling from facial and sinussurgeries (600,000 functional endoscopic surgeries annually, U.S.). |
Each of these applications would involveregulation of pain and inflammation-related mediators like those seen in sinus and nasal inflammation. Firmware programming of ClearUPallows various stimulation protocols to be used for different disease and neural targets, providing accelerated opportunities for newproduct candidates at varying price points.
Activities are ongoing for two productcandidates: (i) npdPP, an at home-use device for treating postoperative pain after sinus surgery, and (ii) npdMI, an at home-use devicefor treating migraine headaches. These product candidates are still in early stages of research and development and will require additionalstudies and regulatory clearances prior to bringing them to market.
npdPP: We completed a ten-person pilotstudy with the U.S. Institute for Advanced Sinus Care and Research (Cleveland, OH) to evaluate a new device for the treatment of postoperativepain after functional endoscopic sinus surgery (“FESS”). The pilot study was conducted to establish clinical feasibility andwe subsequently began a double-blind randomized controlled trial with the Icahn School of Medicine at Mount Sinai to further test thisapplication.
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npdMI: We are in theprocess of investigating the area of migraine headaches, which impacts approximately 1 billion people worldwide and 39 millionpeople in the U.S. As part of our research and development activities for migraine, we have been in communication with the FDA todetermine the next steps and an appropriate regulatory pathway for expanding our indications. We have completed a market andtechnology assessment of a potential migraine indication. While we believe that both clinical and market rationale are positive forsuch use, we have, for the time being, determined to down-prioritize any clinical studies of migraine-related indications based onthe aggressive competition among entrenched incumbents and limited uptake, to date, of existing devices for the treatment and/orprevention of migraine.
We believe our commitment to non-invasivebioelectronic medicine simplifies clinical trial approaches, improves the safety profile important in regulatory matters, and lowers barriersto adoption once in the market. These factors could afford us a unique opportunity for a rapid pace of innovation relative to other therapeuticcompanies. While it is our intention to bring new products to market, therapeutic development is inherently uncertain and there is noguarantee that our research and development efforts will lead to approved products for other clinical indications.
Component Sourcing and Manufacturing
The ClearUP device is comprised ofconventional, off-the-shelf electronic components.
Certain of our electronic components aresourced primarily from China. To increase predictability in sourcing and pricing of electronic components used in our products, we maintainan agreement with Future Electronics, Inc., one of the largest global electronic component distributors. The contract has an initial termof 12 months that automatically renews for additional 12-month periods, subject to annual review, and provides for extended payment terms.Future Electronics may terminate the agreement upon 30 days prior written notice if it determines, in its sole discretion, that we arenot meeting our minimum purchase requirement or we are otherwise not performing our obligations under the agreement.
Packaging production is divided betweenNorth America and China. The plastic enclosure components and sub-assemblies are produced in China. Materials for both packaging and plasticsare commonly available and can be sourced from multiple vendors. Lead times may vary due to supply availability, customs and port managementissues.
Electronic components are assembled,tested, warehoused at, and distributed from North America.
The Company has ISO 13485 certification(70488) required to validate the internal processes being compliant with the FDA 21 CFR Part 820. The Company was re-certified in 2023,with certificates extended until the fourth quarter of 2026.
Intellectual Property / Barriersto Entry
Intellectual Property
Our success depends in part on our abilityto obtain and maintain proprietary protection for our product candidates and other discoveries, inventions, trade secrets and know-howthat are critical to our business operations. Our success also depends in part on our ability to operate without infringing the proprietaryrights of others, and in part, on our ability to prevent others from infringing our proprietary rights. A comprehensive discussion onrisks relating to intellectual property is provided under the section of this Offering Circular entitled “Risk Factors—RisksRelated to Our Intellectual Property.”
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We rely primarily on a combination ofpatent, copyright, trademark, and trade secret laws, as well as contractual provisions with employees and third parties, to establishand protect our intellectual property rights. Our patent strategy is to pursue broad protection for key technologies, supplemented byadditional patent filings covering conceptual methods, specific aspects of current and proposed products, and forward-looking applicationsand technological developments. We also engage in strategic analysis of our owned patent assets, and pursue additional patent claims fromour existing portfolio that may provide us with market advantages. We do not rely heavily on trade secret protection, but do maintaina certain amount of in-house know-how that is not disclosed publicly.
Our intellectual property portfoliocurrently consists of:
· | 10 issued patents in the U.S. and abroad. | |
· | 10 patents pending in the U.S. and abroad. | |
· | 7 trademarks granted in the U.S. and China. | |
· | 2 trademark applications have been filed in the U.S. |
Our intellectual property portfolio includesa large number of disclosures that cover enhanced cost and manufacturability, performance, ergonomics, comfort, ease of use, system expansion,and treatments performed. Identity is protected by way of trademarks. Various aspects of design and function that cannot be readily reverseengineered are held as trade secrets.
In most jurisdictions in which we file,the patent term is 20 years from the earliest date of filing of a non-provisional patent application. However, the term of U.S. patentsmay be extended for delays incurred due to compliance with FDA requirements or by delays encountered during prosecution that are causedby the United States Patent and Trademark Office (“USPTO”). We intend to seek patent term extensions in any jurisdiction wherethese are available and where we also have a patent that may be eligible; however, there is no guarantee that the applicable authoritieswill agree with our assessment of whether such extensions should be granted, and even if granted, the length of such extensions.
Other Barriers to Entry
We have published high-quality clinicalresearch in high-impact peer reviewed journals, establishing Tivic Health as an evidence-based company. Our first-to-market position hassecured a high volume and proportion of positive reviews on our websites and other ecommerce channels. We believe that each of these assets,in addition to our intellectual property and regulatory clearances, will create barriers to entry for competitors.
Government Regulation
ClearUP is a U.S. FDA Class II and EUClass IIa medical device that has received three regulatory clearances: (US FDA 510(k) number K182025, US FDA De Novo number DEN200006and EU CE Mark Certificate number CE (704687). Our EU CE Mark Certificate expires in June 2024 and we are in the process of applying fora new EU CE Mark Certificate under the new EU Medical Device Regulations (MDR) 2017/745. We expect to be compliant with the new regulationsprior to the EU CE Mark Certificate expiry date.
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Regulation by the FDA
In the United States, the Federal Food,Drug, and Cosmetic Act (“FD&C Act”), as well as FDA regulations and other federal and state statutes and regulations,govern medical device design and development, preclinical and clinical testing, device safety, premarket clearance, grant, and approval,establishment registration and device listing, manufacturing, labeling, storage, record-keeping, advertising and promotion, sales anddistribution, export and import, recalls and field safety corrective actions, and post-market surveillance, including complaint handlingand medical device reporting of adverse events.
The FDA classifies medical devices intothree classes (Class I, II or III) based on the degree of risk associated with a device and the level of regulatory control deemed necessaryto ensure its safety and effectiveness. Class I devices are those for which safety and effectiveness can be assured by adherence to theFDA’s general controls for medical devices. Class II devices are subject to the FDA’s general controls and any other specialcontrols the FDA deems necessary to ensure the safety and effectiveness of the device. Class III devices are those that support or sustainhuman life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk ofillness or injury.
De Novo classification is a risk-basedclassification process. The De Novo process provides a pathway to classify novel medical devices for which general controls alone, orgeneral and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is nolegally marketed predicate device. De Novo classified devices fall either into Class I or Class II and may be marketed and used as predicatesfor future premarket notification 510(k) submissions.
In 2019, the FDA issued guidance statingthat it does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of theFD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devicesunder the FD&C Act and implementing regulations. For purposes of its guidance, the FDA defined general wellness products as “productsthat meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a lowrisk to the safety of users and other persons.” Although the FDA classifies our peripheral nerve stimulation platform as a TranscutaneousElectrical Nerve Stimulator (“TENS”) regulated as a Class II medical device, we also intend to pursue development and marketingof general wellness claims and assess if our products fall within the general wellness FDA guidelines.
ClearUP Sinus Relief was cleared under510(k) number K182025 based on clinical data supporting its safety and efficacy for the temporary relief of sinus pain associated withallergic rhinitis. We were subsequently granted the rights to market ClearUP for the temporary relief of moderate to severe congestionunder De Novo number DEN200006.
Labeling
All medical devices commercially distributedin the U.S. must comply with specific FDA labeling requirements. These requirements address the labeling (e.g., device label, Instructionfor Use, package label, etc.) that must be affixed to the device or packaging and, in the case of devices used by the consumer, providedto all users of the device. Our ClearUP labeling has been reviewed by the FDA as part of our regulatory clearances and our quality managementsystem provides for control of documents to prevent changes that might invalidate FDA’s review.
Quality System Regulation
The devices that we commercially distributein the U.S. are subject to pervasive and continuing regulation by the FDA and certain state agencies. This includes product listing andestablishment registration requirements, which facilitate FDA inspections and other regulatory actions. We adhere to applicable currentgood manufacturing practice, or cGMP, requirements, as set forth in the 21 CFR 820 QSR, which require manufacturers, including third-partymanufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all phases ofthe design and manufacturing process. We are also required to verify that our suppliers maintain facilities, procedures and operationsthat comply with applicable quality and regulatory requirements. The FDA enforces the QSR through periodic announced or unannounced inspectionsof medical device manufacturing facilities, which may include the facilities of contractors. FDA regulations also require investigationand correction of any deviations from the QSR and impose reporting and documentation requirements upon us and our third-party manufacturers.
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Post-market surveillance
We must also comply with post-market surveillanceregulations, including medical device reporting (“MDR”), requirements which require that we review and report to the FDA anyincident in which our products may have caused or contributed to a death or serious injury, and any incident in which our device has malfunctionedif that malfunction would likely cause or contribute to a death or serious injury if it were to recur. We must also comply with medicaldevice correction and removal reporting regulations, which require manufacturers to report to the FDA corrections and removals if undertakento reduce a risk to health posed by the device or to remedy a violation of the FD&C Act that may present a risk to health. Althoughwe may undertake recall actions voluntarily, we must submit detailed information on any recall action to the FDA, and the FDA can ordera medical device recall in certain circumstances. To date, we have not been made aware of any reportable incidents that would requireus to submit a medical device report to the FDA or any competent authority globally.
In addition to post-market quality andsafety actions, labeling and promotional activities are subject to scrutiny by the FDA and, in certain circumstances, by the FTC. Medicaldevices approved, cleared, or granted by the FDA may not be promoted for outside their respective Indication for Use, otherwise knownas “off-label” promotion.
Other healthcare laws and regulations
The healthcare industry is also subjectto federal and state fraud and abuse laws, including anti-kickback, self- referral, false claims and physician payment transparency laws,as well as patient data privacy and security and consumer protection and unfair competition laws and regulations. Our operations are alsosubject to certain state and local laws, including manufacturing license, sales and marketing practices, interactions with consumers,consumer incentive and other promotional programs, and state corporate practice and fee-splitting prohibitions.
Currently, ClearUP is not reimbursed byany government or private healthcare program, limiting our exposure under certain laws such as the Sunshine Act.
CE Mark – EuropeanUnion and other jurisdictions that recognize the CE Mark
In 2020 we secured the CE Mark CE 704687allowing sales and marketing of ClearUP in the European Union and in any country that recognizes CE Mark certificate for relief of sinuspain, pressure and congestion, without regard to the cause of pain, pressure and congestion. Sales in such jurisdictions will expose ouroperations to additional regulations.
To the extent that any of our productsare sold in a foreign country, we may become subject to foreign laws, which may include, for example, applicable post-marketing requirements,including post-market clinical follow up, safety surveillance, anti-fraud and abuse laws and implementation of corporate compliance programsand reporting of payments or transfers of value to healthcare professionals. We must operate our business within the requirements of theselaws.
Coverage and reimbursement
Our current product is purchased on acash-pay basis and is not covered by government healthcare programs and/ or other third-party payors. However, we monitor federal andstate legislation and regulatory changes that could affect our results of operations.
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Privacy and security
The Health Insurance Portability and AccountabilityAct of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”),and their implementing regulations, imposes privacy, security and breach reporting obligations with respect to individually identifiablehealth information upon “covered entities” (health care providers, health plans and health care clearinghouses), and theirrespective business associates, individuals or entities that create, received, maintain or transmit protected health information in connectionwith providing a service for or on behalf of a covered entity.
Even when HIPAA does not apply, accordingto the FTC, failing to take appropriate steps to keep consumers’ personal information secure constitutes unfair acts or practicesin or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act. The FTC expects a company’s data securitymeasures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexityof its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health informationis considered sensitive data that merits stronger safeguards.
In addition, certain states and non-U.S.laws, such as the GDPR, govern the privacy and security of health information in certain circumstances, some of which are more stringentthan HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating complianceefforts. Failure to comply with these laws, where applicable, can result in the imposition of significant civil and/or criminal penaltiesand private litigation. For example, California recently enacted the California Consumer Privacy Act, or CCPA, which took effect on January1, 2020 and was amended and expanded by the California Privacy Rights Act, or CPRA, which took effect on January 1, 2023. The CCPA, asamended by the CPRA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights toCalifornia residents, including the right to opt out of certain disclosures of their information and the right to access information abouthow their data is being used.
Environmental Matters
Our operations,properties and products are subject to a variety of U.S. and foreign environmental laws and regulations governing, among otherthings, use of manufacturing components containing substances below established threshold, air emissions, wastewater discharges,management and disposal of hazardous and non-hazardous materials and waste and remediation of releases of hazardous materials. Webelieve, based on current information that we are in material compliance with environmental laws and regulations applicable to usand rely heavily on our outsourced design and manufacturing partners to assist in maintaining compliance.
Facilities
Our principal executive office is locatedat 47685 Lakeview Blvd., Fremont, California 94538. In June 2024, the Company entered into a short-term rental agreement for office spacelocated in Fremont, California. Monthly rent payments required are $1,000 per month and the agreement terminates on December 31, 2024.The agreement can be extended in six-month increments.
Human Capital Resources
As of June 30, 2024, we had 9 full-time employeesand three contractors. None of our employees are represented by a labor union, and we consider our employee relations to be good. Ourhuman capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existingand additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees,consultants and directors through the granting of stock-based compensation awards and cash-based performance bonus awards.
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Legal Proceedings
We are not currently a party to any materiallegal proceedings. We may, however, in the ordinary course of business face various claims brought by third parties, and we may, fromtime to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relatingto employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation. If this wereto happen, the payment of any such awards could have a material adverse effect on our business, financial condition and results of operations.Additionally, any such claims, whether or not successful, could damage our reputation and business.
Corporate Information
The Company wasincorporated in California in September 2016 and reincorporated as a Delaware corporation in June 2021. Our principal executiveoffice is located at 47685 Lakeview Blvd., Fremont, California 94538. Our telephone number is (888) 276-6888. Our website address iswww.tivichealth.com. Information contained on, or that can be accessible through, our website is not a part of this OfferingCircular and the inclusion of our website address in this Offering Circular is an inactive textual reference only.
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MANAGEMENT’S DISCUSSION AND ANALYSISOF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussionand analysis of our financial condition and results of operations together with the financial statements and related notes included elsewherein this Offering Circular. This discussion contains forward-looking statements based upon current expectations that involve risks anduncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of variousfactors, including those discussed in “Risk Factors” and in other parts of this Offering Circular.
Overview
Tivic is a bioelectronic medicine companydeveloping and commercializing drug-free treatments for various diseases and conditions. Bioelectronic medicine, also referred to as electroceuticalsor neuromodulation, is the treatment of disease and conditions by preferentially activating electrical functions of the body to modifycentral or peripheral nerve activity. ClearUP is our first commercial product, and is FDA-approved for the treatment of sinus pain andcongestion. It has also been granted a CE-Mark as a medical device for the treatment of sinus pain, pressure and congestion. ClearUP iscurrently sold in the U.S. directly to consumers on various platforms and through reseller channels. The Company has also recently announcedthe expansion of its IP portfolio and research programs related to vagus nerve stimulation to expand its applications in non-invasivebioelectronic medicine.
Business Overview
Bioelectronic medicine is an emergingmarket. Since our formation in September 2016, we have devoted substantially all of our efforts to the development and marketing of ourproprietary technology platform to provide noninvasive, drug-free treatments and treatment candidates for various diseases and conditions.In 2019, we launched ClearUP in the U.S. market. ClearUP is approved by the FDA for sale in the U.S. for the two FDA-approved indicationsnoted above and has a CE Mark (which covers a third indication of sinus pressure and gives us commercial access to European Union Memberstates and certain other countries). We currently sell ClearUP directly to consumers online through our own website, Amazon, and Walmartin addition to wholesale via major and specialty retailers, such as BestBuy, FSAStore, and others.
Recent Events
In the first half of 2024, we invested in our product,innovation and development as follows:
· | We launched ClearUP 2.0 and decommissioned older models. The new version included new power managementcircuitry and improved power management for faster charging and longer battery life. | |
· | We entered a limited exclusive distribution agreement with McKesson Medical, one of the Top 10 MedicalEquipment Distributors and Suppliers in the nation. Under the terms of the agreement, McKesson affiliate Simply Medical will have certainexclusive distribution rights for Tivic Health’s ClearUP product for Walmart, Target, eBay and Kroger, as well as non-exclusivedistribution rights in other specified on-line channels. | |
· | We announced completion of enrollment in a pilot clinical study with The Feinstein Institutes for Medical Research, testing a proprietary approach to non-invasive vagus nerve stimulation, for which we publicly announced the final data analysis results on May 8, 2024. | |
· | We continued to invest in our intellectual property portfolio, filing our first vagus nerve stimulationpatent and prosecuting existing filings. | |
· | We have continued to intentionally maintain a small core team at this stage of the Company, includingfurther decreasing our headcount in Q2 2024 to reduce operating expenses. We have relied, and continue to rely, heavily on third-partyservice providers, including marketing agencies, a fulfillment warehouse, software-as-a-service platforms, clinical research organizations,academic research partnerships, finance and accounting support, and legal support to carry out our operations. |
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Business Activities
Reverse Stock Split - 2023
Effective August 23, 2023, the Companyimplemented a reverse stock split of the Company’s issued and outstanding shares of common stock at a ratio of 1-for-100. As a resultof the reverse stock split, the total number of shares of Common Stock held by each stockholder of the Company were converted automaticallyinto the number of shares of Common Stock equal to the number of issued and outstanding shares of Common Stock held by each such stockholderimmediately prior to completion of the reverse stock split divided by 100. The Company issued one whole share of the post reverse stocksplit common stock to any stockholder who otherwise would have been entitled to receive a fractional share as a result of the reversestock split. As a result, no fractional shares were issued in connection with the reverse stock split and no cash or other considerationwas paid in connection with any fractional shares that would otherwise have resulted from the reverse stock split. Also, all options,warrants and other convertible securities of the Company outstanding immediately prior to the reverse stock split were adjusted by dividingthe number of shares of common stock into which such options, warrants and other convertible securities were exercisable or convertibleby 100 and multiplied the exercise or conversion price thereof by 100, all in accordance with the terms of the plans, agreements or arrangementsgoverning such options, warrants and other convertible securities and subject to rounding pursuant to such terms. There was no changeto the par value, or authorized shares, of either the common stock or preferred stock, as a result of the reverse stock split. All shareand per share amounts for the Company’s common stock, as well as the options and warrants outstanding and exercise prices thereof,from dates prior to completion of the reverse stock split that are included in this Offering Circular, including the financial statementsand footnotes thereto included herein, have been retroactively restated to give effect to the reverse stock split.
2023 Capital Raises
On February 13, 2023, wesold an aggregate of 200,000 shares of our common stock to certain investors at a public offering price of $25.00 per share (less underwritingdiscounts and commissions) in a firm commitment underwritten public offering. This offering resulted in aggregate gross proceeds to theCompany of $5.0 million. Aggregate net proceeds to the Company, after deducting the underwriting discount and commissions and offeringexpenses paid by the Company, was approximately $3.6 million. ThinkEquity LLC served as underwriter for the offering. The securitiesissued in connection with the offering were registered pursuant to the registration statement on Form S-1 (File No. 333-268010), whichwas initially filed with the SEC on October 26, 2022, and amended on December 09, 2022, December 20, 2022, January 6, 2023, February1, 2023, and February 9, 2023, which the SEC declared effective on February 8, 2023.
From July 11, 2023 toAugust 9, 2023, we sold an aggregate of 1,169,230 shares of common stock to certain investors at prices ranging from $4.00 to $5.50per share in a series of registered public offerings, resulting in aggregate gross proceeds to the Company of approximately $5.2million. Aggregate net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, wasapproximately $4.3 million. Maxim served as the placement agent, on a “reasonable best efforts basis,” in connectionwith each of the offerings. The shares of common stock sold in the offerings were offered pursuant to final prospectus supplements,filed with the SEC, to the Company’s effective shelf registration statement on Form S-3 (File No. 333-269494), which wasinitially filed with the SEC on February 1, 2023 and was declared effective on February 8, 2023. See footnote No. 9 “CommonStock” and No. 10 “Common Stock Warrants” in the financial statements included elsewhere in this Offering Circularfor additional information regarding each of the offerings.
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Operational Updates
Fiscal 2023
In 2023, we invested in our marketing,product design, distribution relationships, and quality systems as follows:
· | In February, Tivic received successful recertification to ISO 13485, the internationalstandard for medical device quality systems. This allowed Tivic, in early 2023, to recertify under the European Union Medical Device Certificate(CE-Mark). | |
· | In March, we completed supplier qualification and first article inspections atALOM Technologies Corporation (“ALOM”) and Microart Services Inc. (“Microart”), allowing Tivic to reduce assemblyproduction costs by 40% and improve gross margins substantively by end of year. | |
· | In April, we completed a 2000-person marketing segmentation study to inform ouradvertising and pricing structure. We subsequently implemented a price increase for ClearUP that negatively impacted direct sales andretail order volumes in Q2, but substantively improved gross profit throughout the course of the year. | |
· | In May, we launched a B2B portal to support our strategy to increase physicianand healthcare provider engagement, including physician resale and recommendation programs for ClearUP. | |
· | In late June, we entered into a non-exclusive distribution agreement with CardinalHealth for our products. | |
· | In late August, we entered into a non-exclusive agreement with AmerisourceBergen, soon to be Cencora, to make our products availableon AmerisourceBergen’s third-party marketplace. | |
· | In late September, we entered into an agreement with InStep Health® to introduce ClearUPto over 2,500 healthcare providers and their patients. | |
· | In Q3, we initiated and subsequently launched a printed circuit board redesign toaddress charging issues associated with a purchased component used in ClearUP. The redesigned circuitry began shipping in late December2023 and launched formally as ClearUP 2.0 in January 2024. |
In 2023, we also invested in our productinnovation and development programs as follows:
· | In early April, we filed our first patent in VagusNerve Stimulation with the USPTO, expanding our IP portfolio into new clinical targets. | |
· | In mid-April, we announced a research collaboration with The Feinstein Institutesfor Medical Research to conduct a pilot clinical study that will test a novel non-invasive bioelectronic device approach for vagus nervestimulation. | |
· | In July, we announced that the USPTO had issued us a sixth patent for our bioelectronicplatform, expanding our IP portfolio to include the proprietary contacts, conductive circuitry design, and algorithms to optimize therapydelivery in our handheld monopolar design. | |
· | In August, we received study approval from the Institutional Review Board (“IRB”)of The Feinstein Institutes for Medical Research and initiated study recruitment and enrollment for our vagus nerve program. | |
· | We expanded our post-operative pain clinical study to include Otolaryngology andFacial Plastic Surgery patients. This study aims to investigate the potential benefits of a drug-free alternative to traditional post-operativepain management methods. |
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As a result of these programs, the Companywas named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2023 in the Medical Devicecategory. Additionally, in 2022, Global Health & Pharma named Tivic Health the Most Pioneering Bioelectronic Medicine Company of 2022.
We have continued to intentionally maintaina small core team at this stage of the Company, including decreasing our headcount to reduce operating expenses. We have relied, and continueto rely, heavily on third- party service providers, including marketing agencies, contract manufacturing organizations, software-as-a-serviceplatforms, clinical research organizations, academic research partnerships, finance and accounting support, and legal support to carryout our operations.
Components of Results of Operations
Revenue
Revenue is generated by the sale of ourClearUP and ancillary products, including accessories and accelerated shipping charges, and is net of return reserves. We currently selldirectly to consumers through our own website, Amazon and Walmart. We also sell to major and specialty distributors and online retailers,such as FSAStore and Best Buy. Noninvasive bioelectronic medicine is an emerging market space that provides consumers with non-drug treatmentsfor various diseases and ClearUP is the first FDA-approved bioelectronic treatment for sinus pain and congestion.
Cost of Sales
Cost of sales consists primarily of thematerials and services to manufacture our products, the internal personnel costs to oversee manufacturing and supply chain functions,and the shipment of goods to customers. A significant portion of our cost of sales is currently in fixed and semi-fixed expenses associatedwith the management of manufacturing and supply chain. Cost of sales is expected to increase on an absolute basis as sales volume increases.Cost of sales is expected to decrease as a proportion of revenue with (i) the continued optimization of our supply chain, and (ii) theallocation of fixed and semi-fixed expenses over increasing unit sales volume over time.
Gross Margin
Gross margin has been and will continue to be affectedby, and is likely to fluctuate on a quarterly basis due to, a variety of factors, including sales volumes, product and channel mix, pricingstrategies, costs of finished goods, reserves for obsolescence, disposal costs of returned and/or obsolete inventory, product return rates,new product launches and potential new manufacturing partners and suppliers. We expect our gross margin to improve with optimization ofour product design and supply-chain, and increasing sales volume over which fixed and semi-fixed costs are allocated.
Operating Expenses
Research and Development Expenses
Research and development expenses consistprimarily of costs incurred to conduct research, including the discovery, development and validation of product candidates. Research anddevelopment expenses include personnel costs, including stock-based compensation expense, third-party contractor services, including developmentand testing of prototype devices, and maintenance of limited in-house research facilities. We expense research and development costs asthey are incurred. We expect research and development expenses to increase with the discovery and validation of new product candidates.
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Sales and Marketing Expenses
Sales and marketing expenses include personnelcosts and expenses for advertising and other marketing services. Personnel costs consist of salaries, bonuses, benefits and stock-basedcompensation expense. We expect sales and marketing expenses to increase modestly as we continue to expand our markets and distributionchannels.
General and Administrative Expenses
General and administrative expenses includeD&O insurance, personnel costs, expenses for outside professional services and other expenses. Personnel costs consist of salaries,bonuses, benefits and stock-based compensation expense. Outside professional services consist of legal, finance, accounting and auditservices, and other consulting fees. We expect general and administrative expenses to remain relatively flat.
Other Income / Expense, Net
Other income and expense include interestexpense, change in fair value of derivative liabilities, loss on extinguishment of debt, and other income.
Results of Operations
Comparison of the Three and Six Months Ended June30, 2024 and2023
The following table summarizes our results of operations (in thousands):
Three Months Ended June30, | Six Months Ended June30, | |||||||||||||||||||||||
2024 | 2023 | Change | 2024 | 2023 | Change | |||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||
Revenue | $ | 140 | $ | 161 | $ | (21 | ) | $ | 474 | $ | 537 | $ | (63 | ) | ||||||||||
Cost of sales | 110 | 100 | 10 | 277 | 363 | (86 | ) | |||||||||||||||||
Gross profit | 30 | 61 | (31 | ) | 197 | 174 | 23 | |||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | 302 | 468 | (166 | ) | 558 | 958 | (400 | ) | ||||||||||||||||
Sales and marketing | 207 | 452 | (245 | ) | 712 | 910 | (198 | ) | ||||||||||||||||
General and administrative | 727 | 1,266 | (539 | ) | 1,614 | 2,547 | (933 | ) | ||||||||||||||||
Total operating expenses | 1,236 | 2,186 | (950 | ) | 2,884 | 4,415 | (1,531 | ) | ||||||||||||||||
Loss from operations | (1,206 | ) | (2,125 | ) | 919 | (2,687 | ) | (4,241 | ) | 1,554 | ||||||||||||||
Other expense: | ||||||||||||||||||||||||
Other expense: | 60 | — | 60 | 60 | — | 60 | ||||||||||||||||||
Total other expense | 60 | — | 60 | 60 | — | 60 | ||||||||||||||||||
Net loss | $ | (1,266 | ) | $ | (2,125 | ) | $ | 859 | $ | (2,747 | ) | $ | (4,241 | ) | $ | 1,494 |
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Revenue
For the three months ended June30, 2024,revenue decreased overall by $21 thousand, or 13%, compared to the same period in 2023, primarily due to a 12% decrease in the per unitaverage sales price.
For the six months ended June30, 2024,revenue decreased overall by $63 thousand, or 12%, compared to the same period in 2023, primarily due to a 27% decrease in unit sales,offset by a 20% increase in the per unit average sales price.
We expect some continued variability in sales dueto reduction in marketing spend and price point positioning for target markets, with the net impact resulting in a higher gross profitand lower loss from operations.
Cost of Sales
For the three months ended June30, 2024, costof sales increased by $10 thousand, or 10%, compared to the same period in 2023, primarily driven by an increase of $20 thousand in theinventory reserve for obsolescence. Excluding the $20 thousand inventory reserve adjustment in the second quarter of 2024, variable costwas $55 thousand, or $68.86 per unit, for the three months ended June30, 2024, compared to $52 thousand, or $64.00 per unit, forthe same period in 2023. Fixed costs were $35 thousand, or $43.25 per unit, for the three months ended June 30, 2024, compared to $49thousand, or $60.48 per unit, for the same period in 2023. The decrease in the fixed cost was primarily due to lower product support costs.
For the six months ended June30, 2024, costof sales decreased by $86 thousand, or 24%, compared to the same period in 2023, primarily driven by the decrease in sales volume. Variablecost was $205 thousand, or $78.95 per unit, for the six months ended June30, 2024, compared to $244 thousand, or $68.50 per unit,for the same period in 2023. Fixed costs were $72 thousand, or $27.90 per unit, for the six months ended June30, 2024, comparedto $119 thousand, or $33.52 per unit, for the same period in 2023. The decrease in the fixed cost was primarily due to lower product supportcosts.
Operating Expenses
Research and DevelopmentExpenses
For the three monthsended June 30, 2024, research and development expenses decreased by $166 thousand compared to the same period in 2023. For the sixmonths ended June 30, 2024, research and development expenses decreased by $400 thousand compared to the same period in 2023. Thedecrease was due to reduced headcount and certain expenses incurred in 2023 which did not recur in 2024. The emphasis of researchand development activities in 2023 was primarily related to a large segmentation study to identify additional incremental marketsegments with high willingness to pay, product design in our next generation device, intellectual property protection, and the studyat The Feinstein Institutes for Medical Research on vagus nerve stimulation.
Sales and Marketing Expenses
For the three monthsended June30, 2024, sales and marketing expenses decreased by $245 thousand compared to the same period in 2023. For the sixmonths ended June 30, 2024, sales and marketing expenses decreased by $198 thousand compared to the same period in 2023. Thedecrease was due primarily to a four-month test program ending in February 2024 with InStep Health focused on education ofhealthcare professionals about the ClearUP solution as well as reductions in agency and staff costs.
General and Administrative Expenses
For the three monthsended June30, 2024, general and administrative expenses decreased by $539 thousand compared to the same period in 2023. Forthe six months ended June 30, 2024, general and administrative expenses decreased by $933 thousand compared to the same period in2023. The overall decreases were attributable to reduced headcount, lower consulting and professional fee expenses, as well as othergeneral administrative expenses.
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Comparison of the Years Ended December 31, 2023 and 2022
The following table summarizes our results of operations (in thousands):
Year Ended December 31, | ||||||||||||
Statement of operations data: | 2023 | 2022 | Change | |||||||||
Revenue | $ | 1,176 | $ | 1,840 | $ | (664 | ) | |||||
Cost of sales | 889 | 1,541 | (652 | ) | ||||||||
Gross profit | 287 | 299 | (12 | ) | ||||||||
Operating expenses: | ||||||||||||
Research and development | 1,655 | 1,730 | (75 | ) | ||||||||
Sales and marketing | 2,125 | 2,792 | (667 | ) | ||||||||
General and administrative | 4,752 | 5,875 | (1,123 | ) | ||||||||
Total operating expenses | 8,532 | 10,397 | (1,865 | ) | ||||||||
Loss from operations | (8,245 | ) | (10,098 | ) | 1,853 | |||||||
Other income: | ||||||||||||
Interest income | 1 | 2 | (1 | ) | ||||||||
Total other income | 1 | 2 | (1 | ) | ||||||||
Net loss before income taxes | $ | (8,244 | ) | $ | (10,096 | ) | $ | 1,852 |
Revenue
Revenue (net of returns)decreased $664 thousand, or -36%, to $1.2 million for the year ended December 31, 2023 from $1.8 million for the year ended December31, 2022, which decrease was primarily attributable to decreased unit sales of 52%. Unit sales were approximately 7,400 for the yearended December 31, 2023 and were approximately 15,400 for the year ended December 31, 2022. Ancillary revenues were less than 1.5%of total revenue for both of the years ended December 31, 2023 and 2022.
Year Ended December 31, | ||||||||||||
Statement of operations data (in thousands): | 2023 | 2022 | Change | |||||||||
Product Revenue | ||||||||||||
Direct-to-consumer | $ | 1,079 | $ | 1,635 | $ | (556 | ) | |||||
Reseller | 261 | 416 | (155 | ) | ||||||||
Returns | (164 | ) | (211 | ) | 47 | |||||||
Revenue | $ | 1,176 | $ | 1,840 | $ | (664 | ) |
Direct-to-consumer product revenuedecreased $556 thousand, or -34%, to $1.1 million for the year ended December 31, 2023 from $1.6 million for the year ended December 31,2022, which was due to decreased unit sales of -53%, offset by an average direct-to-consumer price increase of 46% over the prior year.Direct-to-consumer unit sales were approximately 5,400 for the year ended December 31, 2023 compared to approximately 11,400 for the yearended December 31, 2022. The decrease in unit sales was due to the price increases in 2023 as well as the reduction of unprofitable marketingspend.
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Reseller channel product revenue decreased$155 thousand, or -37%, to $261 thousand for the year ended December 31, 2023 from $416 thousand for the year ended December 31, 2022,attributable to decreased unit sales of 50%. Reseller channel unit sales were approximately 2,000 for the year ended December 31, 2023and were approximately 4,000 for the year ended December 31, 2022. Average reseller channel selling prices increased 21% in 2023 comparedto 2022. The decrease in unit sales and the increase in average selling price were primarily due to the termination of less profitablereseller channels in 2023.
Returns as a percentage of productrevenue was approximately 12% for the year ended December 31, 2023 and 10% for the year ended December 31, 2022.
Cost of Sales
Cost of sales for the year endedDecember 31, 2023 was $889 thousand compared to $1.5 million for the year ended December 31, 2022, a decrease of $652 thousand, or-42%. The decrease was primarily attributable to the -52% decrease in overall unit sales, offset by an increases of $140 thousand ofcosts related to scrapped inventory and $32 thousand for a reserve against inventory. The costs for scrap and inventory reserveswere primarily related to inventory components included in our ClearUP 1.0 unit. With the launch of ClearUP 2.0 in the fourthquarter of 2023, we do not expect to incur similar costs in 2024.
Variable cost of goods sold includesproduct costs, fulfillment, shipping and purchase price variances and other inventory adjustments. Variable cost of goods sold was $641thousand, or $86.61 per unit, for the year ended December 31, 2023, as compared to $1.3 million, or $87.04 per unit, for the year endedDecember 31, 2022. The decrease in variable costs of goods sold was primarily due to reduction in variable costs associated with new supplychain partners, offset by inventory obsolescence associated with the transition in sales to ClearUP 2.0 at year-end.
Fixed cost of goods soldincludes third-party product support and logistic fees and allocated overhead costs. Fixed cost of goods sold increased to $248thousand for the year ended December 31, 2023, as compared to $203 thousand for the year ended December 31, 2022, primarily due toincreased product support costs in 2023, which in turn was primarily associated with certain hourly service charges and periodicminimum spend obligations included Tivic’s contracts with its supply chain partners.
Gross profit for the year ended December31, 2023 was $287 thousand compared to a gross profit of $299 thousand for the year ended December 31, 2022.
Research and Development Expenses
Research anddevelopment expenses decreased by $75 thousand to $1.7 million for the year ended December 31, 2023 from $1.7 million for the yearended December 31, 2022. The decrease was primarily due to reduced compensation costs related to decreased headcount. The emphasisof research and development activities in 2023 was primarily related to our work with The Feinstein Institutes of Medical Research.Activities in 2022 were primarily focused on product research and design in the migraine therapeutic area, initiation of adouble-blind randomized controlled trial for post-operative pain relief following sinus surgery, and enhancement of our intellectualproperty protection.
We expect to incur additional researchand development expenses related to extending the indications for our product(s) in the near term.
Sales and Marketing Expenses
Sales and marketing expensesdecreased to $2.1 million for the year ended December 31, 2023, compared to $2.8 million for the year ended December 31, 2022. Thedecrease was primarily due to a decrease of $925 thousand in advertising and agency costs, offset by increases of $327 thousandrelated to the expansion of our internal marketing team and $76 thousand in public relations costs.
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General and Administrative Expenses
General and administrativeexpenses decreased to $4.8 million for the year ended December 31, 2023, compared to $5.9 million for the year ended December 31,2022, primarily due to decreased legal and professional fees of $919 thousand and a net decrease in other corporate expenses of $221thousand as a result of the Company’s efforts to reduce costs.
Other Income
Other income was immaterial for the yearsended December 31, 2023 and 2022, and consists of interest income from money market accounts.
Liquidity and Capital Resources
Sources of Liquidity
Since our formation in September 2016, we havedevoted substantially all of our efforts to research and development, to regulatory clearance and to early market development and testingfor our first product, released in September 2019 in the United States. We are not profitable and have incurred net losses and negativecash flows from our operations in each year since our inception. As of June30, 2024, we had cash and cash equivalents of $3.7 million,working capital of $4.1 million and an accumulated deficit of $40.6 million. We have financed our operations to date primarily throughissuances of SAFE instruments, convertible notes and convertible preferred stock and the proceeds from registered offerings of our securities.In 2021, we completed our IPO, generating net proceeds to the Company of approximately $14.9 million, and we borrowed $2.6 million byissuing convertible notes payable, the outstanding balance of all of which converted into shares of our common stock in connection withour IPO. On February 13, 2023, we completed the sale of 200,000 shares of our common stock in a firm commitment, fully underwritten registeredpublic offering, resulting in net proceeds to the Company of approximately $3.6 million. From July 11, 2023 to August 9, 2023, wesold an aggregate of 1,169,230 shares of our common stock to certain investors in a series of registered public offerings, resulting inaggregate net proceeds to the Company of approximately $4.3 million. Additionally, in May 2024, we sold an aggregate of 4,710,000 sharesof our common stock, together with Series A warrants to purchase an aggregate of 4,710,000 shares of common stock and Series B warrantsto purchase an aggregate of 7,065,000 shares of common stock, to certain investors in a registered public offering, resulting in net proceedsto the company of approximately $3.3 million.
Although we have taken measures to decrease our operatingexpenses, we expect that our operating expenses may increase significantly as we discover, acquire, validate and develop additional productcandidates; seek regulatory approval and, if approved, proceed to commercialization of new products; obtain, maintain, protect and enforceour intellectual property portfolio; and hire additional personnel when needed. Furthermore, we have incurred, and will continue to incur,significant costs associated with operating as a public company. Management expects to incur substantial additional operating losses forthe foreseeable future to expand our markets, complete development or acquisition of new product lines, obtain regulatory approvals, launchand commercialize our products and continue research and development programs. Based on the Company’s current cash levels and burnrate, amongst other things, the Company believes its cash and financial resources may be insufficient to meet the Company’s anticipatedneeds for the twelve months following the date of issuance of the financial statements for the quarter ended June30, 2024, includedelsewhere in this Report, which raises substantial doubt about the Company’s ability to continue as a going concern within one yearfrom the issuance date of the financial statements.
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Plan of Operation and Future FundingRequirements
We have used our capital resources primarily, to date,to fund marketing and advertising for ClearUP, development of both our trigeminal and our vagus nerve platforms and product candidates,evaluating and diligencing potential licensing and acquisition candidates, and the establishment of public company operating infrastructureand general operations. Although we have taken measures to decrease our operating expenses, we expect that our operating expenses willincrease as we advance our vagus nerve platform, as well as discover, acquire, validate or develop additional product candidates; seekregulatory approval and, if approved, proceed to commercialization of new products; obtain, maintain, protect and enforce our intellectualproperty portfolio; hire additional personnel when needed; and maintain compliance with material government (in addition to environmental)regulations. We plan to increase our research and development investments in our vagus nerve platform and clinical applications thereofin 2024.
Furthermore, we have incurred, and will continue toincur, significant costs associated with operating as a public company. We expect to continue to incur losses for the foreseeable future.At this time, due to the inherently unpredictable nature of research and new product adoption as well as other macroeconomic factors,we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketingapproval and commercialize future product candidates, if at all. For the same reasons, we are also unable to predict how quickly we willgenerate significant revenue from ClearUP product sales or whether, or when, if ever, we may achieve profitability from the sales of oneor more products. Clinical and preclinical development timelines, the probability of success, and costs can differ materially from expectations.In addition, we cannot forecast which product candidates may be best developed and/or monetized through future collaborations, when sucharrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
In addition to the foregoing, we may, from time totime, consider opportunities for strategic acquisitions or other strategic transactions that we believe will align with our growth plan,complement our product offerings and be in the best interest of the Company and our shareholders. If an acquisition or other strategictransaction is identified and pursued, a substantial portion of our cash reserves may be required to complete such acquisition or otherstrategic transaction. If we identify an attractive acquisition that would require more cash to complete than we are willing or able touse from our cash reserves, we will consider financing options to complete the acquisition, including through equity and/or debt financings.
We have generated operating losses in eachperiod since inception. We have incurred an accumulated deficit of $40.6 million through June30, 2024. We expect to incur additionallosses in the future as we expand both our research and development activities. Based on our current cash levels and burn rate, amongstother things, we believe our cash and financial resources may be insufficient to meet our anticipated needs for the next twelve months.As a result, we expect that we will need to raise additional capital to continue operating our business and fund our planned operations,including research and development, clinical trials and, if regulatory approval is obtained, commercialization of future product candidates.
We currently generate sales revenue direct-to-consumerthough our own websites, Amazon.com and Walmart.com. We also sell to major and specialty U.S. online retailers such as BestBuy and FSAStoreand through distributors including McKesson’s affiliate Simply Medical, Cardinal Health and Cencora (formerly known as AmerisourceBergen). Our ability to grow sales revenue will depend on successfully executing a comprehensive marketing campaign to drive additionalsales through existing and new channels. Long-term growth will be commensurate with our ability to successfully identify, develop, andsecure regulatory approval of one or more additional product candidates beyond ClearUP. Until such time as we can generate significantrevenue from product sales, if ever, we expect to finance our operations through private or public equity or debt financings, collaborativeor other arrangements with corporate, foundation or government funding sources, or through other sources of financing. We do not knowwhether additional financing will be available on commercially acceptable terms, or at all, when needed. If adequate funds are not availableor are not available on commercially acceptable terms, our ability to fund our operations, support the growth of our business or otherwiserespond to competitive pressures could be significantly delayed or limited, which could materially adversely affect our business, financialconditions or results of operations, and we may have to significantly delay, scale back or discontinue the development and commercializationof our products and/or future product candidates.
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The timing and amount of our operating expenditureswill depend largely on:
· | our ability to raise additional capital if and when necessary and on terms favorable to the Company; | |
· | the timing and progress of sales initiatives driving top-line revenue; | |
· | the availability of electronic parts and other components for our products, as well as our ability tosource such parts and components at favorable prices; | |
· | the timing and adoption rate of ClearUP line extensions at lower cost of goods; | |
· | the payment terms and timing of commercial contracts entered into for manufacturing and sales of our productsto and through online third-party retailers; | |
· | the timing and progress of preclinical and clinical development activities; | |
· | the number and scope of preclinical and clinical programs we decide to pursue; | |
· | the timing and amount of milestone payments we may receive under any future collaboration agreements; | |
· | whether we close potential future strategic acquisition opportunities, and if we do, our ability to successfullyintegrate acquired assets and/or businesses with our own; | |
· | our ability to source new business opportunities through licenses and research and development programsand to establish new collaboration arrangements; | |
· | the costs involved in prosecuting and enforcing patent and other intellectual property claims; | |
· | the cost and timing of additional regulatory approvals beyond those currently held by us; | |
· | our efforts to enhance operational systems and hire additional personnel, including personnel to supportfinance, sales, marketing, operations and development of our product candidates and satisfy our obligations as a public company; and | |
· | our efforts to maintain compliance with material government (including environmental) regulations. |
Until such time, if ever, as we can generate substantialrevenue from product sales, we expect to fund our operations and capital funding needs through equity and/or debt financings. We may alsoconsider entering into collaboration arrangements or selectively partnering with third parties for clinical development and commercialization.The sale of additional equity would result in additional dilution to our stockholders. The incurrence of additional debt would resultin debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrictour operations or our ability to incur additional indebtedness or pay dividends, among other items. If we raise additional funds throughgovernmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with thirdparties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidatesor grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forcedto make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail plannedprograms. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.
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Cash Flows
The following table summarizes our cash flows for the period indicated(in thousands):
Six Months Ended | ||||||||
June 30, | ||||||||
2024 | 2023 | |||||||
(unaudited) | (unaudited) | |||||||
Cash used in operating activities | $ | (2,953 | ) | $ | (4,866 | ) | ||
Cash used in investing activities | – | (118 | ) | |||||
Cash provided by (used in) financing activities | 3,251 | 4,126 | ||||||
Net increase (decrease) in cash and cash equivalents | $ | 298 | $ | (858 | ) |
Year Ended December 31, | ||||||||
2023 | 2022 | |||||||
Cash used in operating activities | $ | (8,511 | ) | $ | (8,919 | ) | ||
Cash used in investing activities | (118 | ) | (11 | ) | ||||
Cash provided by (used in) financing activities | 8,507 | (528 | ) | |||||
Net decrease in cash and cash equivalents | $ | (122 | ) | $ | (9,458 | ) |
Operating Activities
Net cash used inoperating activities for the six months ended June 30, 2024 was $3.0 million, which consisted primarily of a net loss of $2.7million, decreased by non-cash charges of $190 thousand and increased by a net decrease of $396 thousand in our net operating assetsand liabilities. The non-cash charges primarily consisted of stock-based compensation of $108 thousand and amortization ofright-of-use assets of $76 thousand. The change in our net operating assets and liabilities was primarily due to a decrease inaccounts payable and accrued expenses of $617 thousand, an increase in accounts receivable of $153 thousand, an increase in prepaidand other current assets of $139 thousand, and a decrease of $79 thousand in lease liabilities.
Net cash used in operating activities for thesix months ended June 30, 2023 was $4.9 million, which consisted primarily of a net loss of $4.2 million, decreased by non-cash chargesof $256 thousand and a net decrease of $881 thousand in our net operating assets and liabilities. The non-cash charges primarily consistedof stock-based compensation of $165 thousand and amortization of right-of-use assets of $85 thousand. The change in our net operatingassets and liabilities was primarily due to a decrease in accounts payable and accrued expenses of $721 thousand and an increase of $125thousand in inventory.
Net cash used in operatingactivities for the year ended December 31, 2023 was $8.5 million, which consisted primarily of net loss of $8.2 million decreased bynon-cash charges of $485 thousand and increased by a net change of $752 thousand in our net operating assets and liabilities. Thenon-cash charges primarily consisted of stock-based compensation of $271 thousand and amortization of right-of-use assets of $174thousand. The change in our net operating assets and liabilities was primarily due to a decrease in accounts payable of $610thousand, an increase in prepaid and other current assets of $92 thousand, a decrease in lease liabilities of $161 thousand and anincrease in accrued expenses of $103 thousand.
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Net cash used in operatingactivities for the year ended December 31, 2022 was $8.9 million, which consisted primarily of net loss of $10.1 million decreasedby non-cash charges of $572 thousand and further decreased by a net change of $605 thousand in our net operating assets andliabilities. The non-cash charges primarily consisted of stock-based compensation of $398 thousand and amortization of right-of-useassets of $164 thousand. The change in our net operating assets and liabilities was primarily due to an increase in accounts payableof $534 thousand and a decrease in prepaid and other current assets of $558 thousand, offset by an increase in inventory of $434thousand and a decrease in lease liabilities of $178 thousand.
Investing Activities
There was no cash used in investing activitiesfor the six months ended June30, 2024. Net cash used in investing activities during the six months ended June30, 2023 wasrelated to the purchases of property and equipment.
Net cash used in investing activitiesduring the years ended December 31, 2023 and 2022 was related to the purchases of equipment and product development.
Financing Activities
Our financing activities provided $3.3 million ofcash during the six months ended June30, 2024, which consisted primarily of proceeds from the sale of 4,710,000 shares of our commonstock and Common Warrants to purchase an aggregate of 11,775,000 shares of common stock in May 2024, net of offering discounts and othercosts. For the six months ended June30, 2023, our financing activities provided $4.1 million of cash, which consisted primarilyof proceeds from the sale of 200,000 shares of our common stock, net of offering discounts and other costs.
Our financing activities provided $8.5million of cash during the year ended December 31, 2023, which consisted primarily of proceeds from the sale of an aggregate of 1,369,230shares of our common stock, net of offering discounts and other costs.
Our financing activities used $528 thousandof cash during the year ended December 31, 2022, which consisted of $584 thousand of deferred offering costs in connection with the saleof our common stock which closed subsequent to December 31, 2022, offset by $56 thousand of proceeds from the exercise of stock options.
Known Trends or Uncertainties
As discussed elsewhere in this Offering Circular,the world has continued to be been affected by the lingering effects of theCOVID-19 pandemic, the ongoing conflicts between Russiaand Ukraine as well as Israel and Hamas, economic uncertainty in human capital management (“HCM”) and certain other macroeconomicfactors. Inflation has risen, Federal Reserve interest rates have increased over the last year, and the general consensus among economistscontinues tosuggest that we should expect a higher recession risk to continue for the near term. Climate change continues to bean intense topic of public discussion and is adding additional challenges and financial burden due to impending preparations and changesin the customer mindset. Additionally, it is possible that U.S. policy changes, including changes and uncertainty as a result of the upcomingU.S. presidential election, could increase market volatility. These factors, amongst other things, could result in further economic uncertaintyand volatility in the capital markets in the near term, and could negatively affect our operations. Effects of the pandemic and recenteconomic volatility have negatively impacted our business in various ways over the last three years, including as a result of global supplychain constraints at least partially attributable to the pandemic. We will continue to monitor material impacts on our HCM strategies,including potential of employee attrition, amongst other things.
Global supply chain shortages (especially when coupledwith the increase in inflation and other economic factors) could result in an increase in the cost of the components used in our products,which could result in a decrease of our gross margins or in us having to increase the price at which we sell our products until supplychain constraints are resolved. Additionally, in the event that the price of our components increases significantly or we are unable tosource sufficient components and materials from our current suppliers, or to develop relationships with additional suppliers, to manufactureenough of our products to satisfy demand, we may have to cease or slow down production and our business operations and financial conditionmay be materially harmed and we may need to alter our plan of operation.
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The United States has implemented tariffson certain imported goods, including on certain items imported from China. In addition, China has imposed tariffs on a wide range of Americanproducts and placed restrictions on the export of certain items, including gallium and germanium, in retaliation for these American tariffs.As a result, there is a concern that the imposition of additional tariffs by the United States could result in the adoption of additionaltariffs or export restrictions by China and/or other countries. Any resulting trade war could negatively impact our business. The impositionof tariffs on items imported by us from China or other countries could increase our costs and could result in lowering our gross marginon products sold.
Additionally, U.S. and global markets are experiencingvolatility and disruption following the escalation of geopolitical tensions and the ongoing military conflicts between Russia and Ukraineand between Israel and Hamas. Although the length and impact of the ongoing military conflicts is highly unpredictable, the conflictsin Ukraine and the Middle East could lead to market disruptions, including significant volatility in commodity prices, credit and capitalmarkets, as well as further supply chain interruptions. Additionally, the recent military conflict in Ukraine has led to sanctions andother penalties being levied by the United States, European Union and other countries against Russia. Additional potential sanctions andpenalties have also been proposed and/or threatened. Russian military actions and the resulting sanctions could adversely affect the globaleconomy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult forus to obtain additional funds.
Although our business has not been materially impactedby the ongoing military conflict between Russian and Ukraine or the conflict betweenIsrael and Hamas to date, it is impossible topredict the extent to which our operations, or those of our suppliers and manufacturers, will be impacted in the short and long term,or the ways in which the conflict may impact our business. The extent and duration of the military action, sanctions and resulting marketdisruptions are impossible to predict, but could be substantial. We are continuing to monitor the situations in Ukraine, the Middle Eastand globally to assess potential impacts on our business.
As a result of these global issues and other macroeconomicfactors, it has been difficult to accurately forecast our revenues or financial results, especially given the near and long term impactof the pandemic, geopolitical issues, inflation, the Federal Reserve maintaining high interest rates, the potential for a recession andrecent uncertainties stemming from the upcoming election. In addition, while the potential impact and duration of these issues on theeconomy and our business may be difficult to assess or predict, these world events have resulted in, and may continue to result in, significantdisruption of global financial markets, and may reduce our ability to access additional capital, which could negatively affect our liquidityin the future. Our results of operations could be materially below our forecasts as well, which could adversely affect our results ofoperations, disappoint analysts and investors, or cause our stock price to decline. Furthermore, a decrease in orders in a given periodcould negatively affect our revenues in future periods.
These global issues and events may also have the effectof heightening many risks associated with our customers and supply chain. We may take further actions that alter our operations as maybe required by federal, state, or local authorities from time to time, or which we determine are in our best interests. In addition, wemay decide to postpone or abandon planned investments in our business in response to changes in our business, which may impact our abilityto attract and retain customers and our rate of innovation, either of which could harm our business.
Inflation
Inflation has increased recently and future ratesare unknown. Inflationary factors, such as increases in the cost of our products (and components thereof), interest rates, overhead costsand transportation costs may adversely affect our operating results. Although we do not believe that inflation has had a material impacton our financial position or results of operations to date, we may experience some effect in the near future (especially if inflationrates continue to rise) due to supply chain constraints, consequences associated with the ongoing conflicts between Russia and Ukraineand Israel and Hamas, employee availability and wage increases, trade tariffs imposed on certain products from China and increased componentand services pricing.
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Off-Balance Sheet Arrangements
We have not entered into any off-balancesheet arrangements.
Contractual Obligations and Commitments
Office Lease
The Company previously entered into a noncancelableoperating lease for approximately 9,091 square feet of office space in Hayward, California as its headquarters. The lease was set to expirein October 2025 and there was no option to renew for an additional term. The Company was obligated to pay, on a pro-rata basis, real estatetaxes and operating costs related to the premises. The lease was terminated on May 31, 2024 and the Company has no further obligationswith regard to the lease.
On May 30, 2024, we entered into a Co-WorkingSpace Agreement, pursuant to which we rent office space located at 47685 Lakeview Blvd., Fremont, California for a total $1 thousand amonth. The agreement has an initial term of six months, commencing June 1, 2024, after which it will automatically renew on a month tomonth basis until terminated.
Lease costs recorded during the six month periodsended June30, 2024 and 2023 were $84 thousand and $101 thousand, respectively.
We enter into contracts in the normal courseof business with our contract manufacturer and other vendors to assist in the manufacturing of our products and performance of our researchand development activities and other services for operating purposes. These contracts generally provide for termination for convenienceafter expiration of an advance notice period ranging from 0 to 60 days, and therefore are cancelable contracts and not included in thetable of contractual obligations and commitments. Except as set forth above, there have been no material changes to our previously disclosedbusiness strategy with respect to our contractual obligations as disclosed under Management’s Discussion and Analysis of FinancialCondition and Results of Operations - Contractual Obligations in the Company’s Annual Report on Form 10-K for the year ended December31, 2023.
Critical Accounting Policies andSignificant Judgments and Estimates
The preparation of our financial statementsin conformity with accounting principles generally accepted in the United States requires us to make estimates and judgments that affectthe amounts reported in those financial statements and accompanying notes. Although we believe that the estimates we use are reasonable,due to the inherent uncertainty involved in making those estimates, actual results reported in future periods could differ from thoseestimates.
We believe that the accounting policiesdescribed below involve a high degree of judgment and complexity. Accordingly, these are the policies we believe are the most criticalto aid in fully understanding and evaluating our financial condition and results of our operations.
Revenue Recognition
The Company recognizes revenue from productsales in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)Topic 606, Revenue from Contracts with Customers (“Topic 606”). The standard applies to all contracts with customers, exceptcontracts that are within scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.
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Under Topic 606, an entity recognizesrevenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entityexpects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determinesare in within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii)identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to theperformance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Companyonly applies the five-step model to contracts when it is probable the entity will collect the consideration it is entitled to in exchangefor the goods or services it transfers to the customer. At contract inceptions, once the contract is determined to be within the scopeof Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligationsand assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction pricethat is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
The Company sells its products direct-to-consumerand third-party online resellers. Revenue is recognized when control of the promised goods is transferred to the customers or retailer,in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods and services. Revenue associatedwith products holding rights of return are recognized when the Company concludes there is not a risk of significant revenue reversal inthe future periods for the expected consideration in the transaction.
The Company may receive payments at theonset of the contract and before goods have been delivered. In such instances, the Company records a deferred revenue liability. The Companyrecognizes these contract liabilities as sales after the revenue criteria are met.
The Company relies on third parties tohave procedures in place to detect and prevent credit card fraud, as the Company has exposure to losses from fraudulent charges. The Companyrecords the losses related to chargebacks as incurred.
The Company has also elected to excludefrom the measurement of the transaction price sales taxes remitted to governmental authorities.
Stock-Based Compensation
We measure all stock options and otherstock-based awards granted to our employees, directors, consultants and other non-employee service providers based on the fair value onthe date of the grant. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognizedon a straight- line basis based on the grant date fair value over the associated service period of the award, which is typically the vestingterm. Compensation expense related to awards to employees with performance-based vesting conditions is recognized based on grant datefair value over the requisite service period using the accelerated attribution method to the extent achievement of the performance conditionis probable. Non-employee option awards are measured at the earlier of the commitment date for performance by the counterparty or thedate when the performance is complete, and compensation expense is recognized in the same manner as if we had paid cash for goods or services.
We classify stock-based compensationexpense in our statement of operations in the same way the award recipient’s payroll costs are classified or in which the awardrecipients’ service payments are classified.
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We use the Black-Scholes option pricingmodel to estimate the fair value of stock options on the date of grant. Using the Black-Scholes option pricing model requires managementto make significant assumptions and judgments. We determined these assumptions for the Black-Scholes option-pricing model as discussedbelow.
· | Expected Term—The expected term represents the period that the stock-basedawards are expected to be outstanding. As we do not have sufficient historical experience for determining the expected term of the stockoption awards granted, we based our expected term for awards issued to employees and non-employees using the simplified method which ispresumed to be the midpoint between the vesting date and the end of the contracted term. | |
· | Risk-Free Interest Rate—The risk-free interest rate is based on theU.S. Treasury yield curve in effect at the date of grant for zero-coupon U.S. Treasury constant maturity notes with terms approximatelyequal to the stock-based awards’ expected term. | |
· | Expected Volatility—Since we do not have a trading history of commonstock, the expected volatility was derived from the average historical stock volatilities of the common stock of several public companieswithin the industry that we consider to be comparable to our business over a period equivalent to the expected term of the stock-basedawards. | |
· | Dividend Rate—The expected dividend rate is zero as we have not paidand do not anticipate paying any dividends in the foreseeable future. | |
· | Fair Value of Common Stock—Prior to our initial public offering (“IPO”),the fair value of the shares of common stock underlying the stock-based awards was determined by our board of directors with input frommanagement. Because there was no public market for our common stock, our board of directors determined the fair value of our common stockat the time of grant of the stock-based award by considering a number of objective and subjective factors, including having valuationsof the common stock performed by a third-party valuation specialist, as further described below. |
As of December 31, 2023, the total compensationcost related to nonvested service-based awards not yet recognized is $440 thousand. The weighted-average period over which the nonvestedawards is expected to be recognized is 2.04 years. The aggregate intrinsic value of stock options outstanding as of December 31, 2023was zero for both vested and unvested options.
Common Stock Valuations
The fair value of the shares of commonstock underlying our stock-based awards prior to our IPO was determined by our board of directors with input from management and contemporaneousthird-party valuations. We believe that our board of directors had the relevant experience and expertise to determine the fair value ofour common stock prior to our IPO. Given the absence of a public trading market of our common stock, and in accordance with the AmericanInstitute of Certified Public Accountants Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation,our board of directors exercised reasonable judgment and considered numerous and subjective factors to determine the best estimate ofthe fair value of our common stock at each grant date. These factors included:
· | contemporaneous valuations of our common stock performed by independent third-party specialists; | |
· | the prices, rights, preferences and privileges of our convertible preferred stockrelative to those of our common stock; | |
· | the prices of common or convertible preferred stock sold to third-party investors by us; | |
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· | lack of marketability of our common stock; | |
· | our actual operating and financial performance; | |
· | current business conditions and projections; | |
· | hiring of key personnel and the experience of our management; | |
· | the history of the company and notable milestones; | |
· | our stage of development; | |
· | likelihood of achieving a liquidity event, such as an initial public offering or a merger or acquisitionof our company given prevailing market conditions; | |
· | the market performance of comparable publicly traded companies; and | |
· | the U.S. and global capital market conditions. |
In valuing our common stock, our boardof directors determined the equity value of our business using the hybrid method with input from management and contemporaneous third-partyvaluations. The hybrid method is based upon the probability-weighted value across two scenarios, being (i) successfully consummating aninitial public offering and (ii) alternative scenarios in which an initial public offering is not consummated. The hybrid method can bea useful alternative to explicitly modeling all probability-weighted expected return scenarios in situations when the company has transparencyinto one or more near term exits but is unsure about what will occur if current plans do not materialize. In the first scenario, the potentialexit date, the probability exit value and the likelihood of interim financings were considered. In the second scenario, which was assignedthe residual probability, the potential exit date, the equity volatility, the assumed interest rate, the dividend yield and equity inflectionpoints at which the allocation of proceeds changes were considered. The valuation method considers the total number of shares authorizedand outstanding, as well as recent issuances of both preferred and common stock.
Application of these approaches involvesthe use of estimates, judgment and assumptions that are highly complex and subjective, such as those regarding the time to the liquidationevent and volatility. Changes in these estimates and assumptions or the relationships between these assumptions impact our valuationsas of each valuation date and may have a material impact on the valuation of common stock.
Since completion of our IPO in 2021,the fair value of each share of underlying common stock has been based on the closing price of our common stock as reported by the NasdaqCapital Market on the date of grant, or as otherwise provided in 2021 Equity Incentive Plan. Future expense amounts for any particularperiod could be affected by changes in our assumptions or market conditions.
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Emerging Growth Company Status
We are an “emerging growth company,”as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and may remain an emerging growth company until December31, 2026. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosurerequirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:
· | reduced disclosure about our executive compensationarrangements; | |
· | no non-binding stockholder advisory votes on executive compensation or golden parachute arrangements;and | |
· | exemption from the auditor attestation requirement in the assessment of our internal control over financialreporting. |
We have taken advantage ofreduced reporting requirements in this Offering Circular and may continue to do so until such time that we are no longer an emerginggrowth company. We will remain an “emerging growth company” until the earliest of (a) the last day of the fiscal year inwhich we have total annual gross revenues of $1.235 billion or more, (b) December 31, 2026, the last day of the fiscal yearfollowing the fifth anniversary of the completion of our IPO, (c) the date on which we have issued more than $1.0 billion innonconvertible debt during the previous three years or (d) the date on which we are deemed to be a large accelerated filer under therules of the SEC. Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transitionperiod for complying with new or revised accounting standards. We have irrevocably elected not to avail ourselves of this extendedtransition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption ofsuch standards is required for other public companies.
In addition, we are also a smaller reportingcompany as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growthcompany. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to takeadvantage of these scaled disclosures for so long as (i) our voting and non-voting common stock held by non-affiliates is less than $250.0million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100.0 million during themost recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measuredon the last business day of our second fiscal quarter.
Recent Accounting Pronouncements
For a description of recent accountingpronouncements, see Note 2 of the notes to our audited financial statements for the year ended December 31, 2023, included elsewhere inthis Offering Circular.
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DIRECTORS, EXECUTIVE OFFICERS, PROMOTERSAND CONTROL PERSONS
Directors and Executive Officers
The following table sets forth the names, ages, and positions ofour executive officers and directors:
Name | Age | Position | ||
Jennifer Ernst | 55 | Chief Executive Officer and Director | ||
Kimberly Bambach | 52 | Interim Chief Financial Officer | ||
Blake Gurfein, PhD | 40 | Chief Scientific Officer | ||
Sheryle Bolton | 77 | Chair of the Board | ||
Karen Drexler | 64 | Director | ||
Dean Zikria | 56 | Director | ||
Christina Valauri | 69 | Director |
Executive Officers
Jennifer Ernst isa co-founder and has served as our Chief Executive Officer and as a director since September 2016; she also served as our ChiefFinancial Officer from September 2016 to July 2021. Previously, Ms. Ernst served as the Chief Executive Officer of the U.S.subsidiary of Thin Film Electronics ASA from April 2011 to December 2015. Ms. Ernst also served as the Chief Strategy Officer ofThin Film Electronics ASA from January 2014 to December 2015, where she established and guided the strategic planning process acrossall business functions and four separate product lines. Ms. Ernst also worked for Xerox PARC for over 20 years, where she heldmultiple go-to-market roles, including as the Director of Business Development. Ms. Ernst previously served as a director ofFlexTech Alliance, the U.S. national consortium for flexible and printed electronics, for four years, including one year as theChair. Ms. Ernst earned her Master of Business Administration degree from Santa Clara University.
Kimberly Bambach currentlyserves as Tivic’s Interim Chief Financial Officer since May 2023, with 30+ years of financial leadership experience in both publicand private companies. Her background includes financial leadership in medical and retail markets, manufacturing, wholesale distribution,licensing, digital media, and broadcasting. Ms. Bambach specializes in scaling finance organizations in early development stage to postcommercial, large international corporations and IPOs assisting with the navigation through transitions between the different phases ofbusiness and fundraising efforts. Prior to joining the Company, Ms. Bambach served as the Chief Financial Officer at Jushi Holdings, Inc.,where she played a pivotal role in the company’s rapid growth, reverse merger, multi-state acquisitions, equity/debt raises as wellas the associated regulatory filings in both IFRS & US GAAP. She received Bachelors of Science Degrees in Finance from SUNY Brockport,and an MBA in Strategic Planning from the Lubin School of Business at Pace University in New York City.
Blake Gurfein,PhD serves as our Chief Scientific Officer, a role that he has held since March 2019, prior to which he served as our VicePresident of Research commencing in January 2018. Dr. Gurfein leads our clinical and scientific research. In addition to hisfull-time role with the Company, he has also served as an Adjunct Assistant Professor of Medicine at the University of CaliforniaSan Francisco since 2012. Dr. Gurfein is an expert in neuromodulation device development and has served as a research executive andconsultant for several medical device and pharma companies, including as Chief Scientific Officer of Rio Grande Neurosciences from2014 to 2017 and as a Medical Writer for EMD Serono/Pfizer in 2012. Dr. Gurfein’s prior research in neuroscience andimmunology was funded by the National Institutes of Health and philanthropic donors, yielding high-impact journal publications. Dr.Gurfein has a Ph.D. in Neuroscience from the Icahn School of Medicine at Mount Sinai and an Sc.B. in Neuroscience from BrownUniversity.
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Non-Employee Directors
SheryleBolton has served as a director on our board since July 16, 2019, and as Chair of the board since August 18, 2021. She is anexperienced serial technology entrepreneur, public company chief executive officer, corporate executive, speaker, board member, andinvestor. Ms. Bolton has been a corporate executive in financial services, media, and health care and has served on the boards ofprivate and public corporations, ranging from large groups of mutual funds to technology and finance companies, as well asnon-profits, including an NGO, where she served as Chair of the audit committee, focused on financing small businesses in Asia andSub-Saharan Africa and Berry College, a private college with an internationally known work-study program. Ms. Bolton worked inprivate equity investing as an investment banker at Merrill Lynch Capital Markets, as Director of Strategy at Home Box Office and inasset management at Rockefeller & Co. In her roles as Chief Executive Officer, she raised significant funding for severalstart-ups from angels, venture capital, and the public and institutional markets. She previously served as Chief Executive Officerof Scientific Learning Corporation, a health care and educational technology company, where she led the company from pre-product toIPO with venture funding from Warburg Pincus. She also served as Chief Executive Officer and Chair of the public company aftercompletion of their IPO. She has served as a board member for more than forty Scudder-Kemper mutual funds. From 2015 to 2021, Ms.Bolton was an adjunct Professor of Practice at Hult International Business School, where she taught entrepreneurship and financecourses in graduate and undergraduate programs. She has also been an invited speaker on business and entrepreneurship in the U.S.,Asia, the Pacific Rim, Latin America, and Europe. Harvard Business School recognized Ms. Bolton as one of its most influentialfemale graduates in Silicon Valley and the San Francisco Bay Area. She was a recipient of the first Springboard All-Women’sIPO Class award, formerly served as Chair of Watermark, the largest organization in Silicon Valley for female executives andentrepreneurs, and is a recipient of the “A Woman Who Made Her Mark” award, among many other honors and recognition. Ms.Bolton started her career as a Peace Corps Volunteer in Africa. She holds a Bachelor of Arts. and a Master of Arts in Linguisticsfrom the University of Georgia and a Master of Business Administration from Harvard Business School.
Karen Drexler has servedas a director on our board since July 16, 2019. Ms. Drexler has tendered her resignation from the board and its committees effective September30, 2024, but will continue as an advisor to the Company thereafter. Ms. Drexler is a serial entrepreneur with expertise in the fieldsof digital health, medical devices and diagnostics. From September 2014 to June 2020 she served as board member of, and from June 2016until June 2020, she was the Chief Executive Officer of, Sandstone Diagnostics, Inc., a private company developing instruments and consumablesfor point-of-care medical testing. Ms. Drexler also serves on the boards of ResMed (NYSE: RSMD), OutSet Medical (NASDAQ: OM), EBR Systems(ASX: EBR), VIDA Health, a leading company in Al-powered lung intelligence solutions and analytics, and Huma.ai, a medical intelligencecompany. From 2011 to 2017, she served as Chair of the board of Hygieia, Inc., a digital insulin therapy company, where she remains involvedas an advisor to the chief executive officer. She also acts as a senior strategic advisor for other early-stage companies and spent 11years on the board of the Keller Center for Innovation in Engineering Education at Princeton University. Ms. Drexler has served on numerousprivate company boards in the fields of diagnostics, medical devices, and digital health. She is an active mentor and advisor with Astia,a global nonprofit that supports high-potential female founders. She is a founding member of Astia Angels, a network of individual investorswho fund such founders, and a lead mentor with StartX, the Stanford University incubator. She is also on the Life Science and Women’sHealth Councils for Springboard, an accelerator for women-led technology-oriented companies. Through her work with Astia, Springboard,and StartX, she interacts with many promising young medtech companies. Ms. Drexler was a founder, president, and Chief Executive Officerof Amira Medical Inc., a private company focused on minimally invasive glucose monitoring technology, from 1996 until it was sold to RocheHolding AG in 2001. Before joining Amira Medical, she held management roles at LifeScan and played a key role in its sale to Johnson &Johnson (NYSE: JNJ). Ms. Drexler graduated magna cum laude with a Bachelor of Science in Chemical Engineering from Princeton Universityand earned a Master of Business Administration with honors from the Stanford University Graduate School of Business.
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Dean Zikria has served as a director on our board since July 10, 2019. Mr. Zikria brings deep industry experience in allergy and asthma as wellas other chronic diseases to the board. Since August 2019, Dean has been the Founder, CEO and Chairman of Mind Machine LLC, aSilicon Valley based marketing/advertising agency—focused on the MedTech industry. From June 1, 2021 until January 2023, heserved as the Chief Commercial Officer at Intuity Medical Inc., a Silicon Valley MedTech company launching a highly disruptiveglucose meter in the diabetes industry. In addition, he has served as Chairman of DZ Advisors, LLC, a company founded by Mr. Zikriain 2017 that provides consulting and advisory services to the medtech, biotech, digital health and pharmaceutical industries; sinceinception, where he also served as President from December 2017 until May 31, 2021. Mr. Zikria also sits on the boards of thefollowing privately held companies: AsthmaTek, Inc., a startup digital health company in the asthma space; Brev.Dev, Inc., atechnology company developing a disruptive platform to aid developers. Dean previously served as Chief Executive Officer ofSpirosure Inc., a FeNO detection company for asthma diagnostics, from 2014 to 2017. Additionally, he previously served as head ofglobal marketing for Johnson & Johnson’s Animas Corporation within their medical device & diagnostics division. He washead of strategy for Pfizer Pharmaceuticals U.S. Cardiovascular Unit, a division with approximately $7 billion in annual revenues.Mr. Zikria brings experience in strategic planning, scenario planning and analysis, and mergers and acquisitions, includingsourcing, transactions and integration.
Christina Valauri has served as a strategicadvisor to the company since April 2023 and a director on our board since July 1, 2024. Ms. Valauri has over 30 years of experience inthe capital markets holding leadership roles as a healthcare analyst, director of research and senior manager at several investment banksand global financial firms. Ms. Valauri was a healthcare equity research analyst from June 1984 to December 1999, primarily focused onthe biotechnology and medical technology sectors and held this position at the following firms: Credit Lyonnais Securities (USA), Inc.April 1998 to December 1999 (acquired by Credit Agricole 2003). Grunthal & Company October 1996 to March 1998, Hancock InstitutionalEquities Services August 1995 to October 1996, Arnhold and S. Bleichroeder April 1994 to July 1995, Paine Webber Incorporated October1987 to March 1994 (acquired by UBS 2000), and Arnhold and S. Bleichroeder February 1984 to September 1987. Ms. Valauri held senior equityresearch management roles from April 1998 to December 2015. Ms. Valauri served as a Global Head of Equity Research at Cantor FitzgeraldLLC from August 2013 to July 2015, and served as a US Director of Research at Natixis (USA) from December 2008 to September 2012 as wellas serving from September 2012 to July 2013 as a senior member of the firm’s broker dealer management team for Natixis SecuritiesAmericas LLC., which provided regulatory and supervisory oversight. Prior to joining Natixis Ms. Valauri was the Director of Researchat Broadpoint Securities Group, Inc. (broker-dealer subsidiary of First Albany Cos. Inc.) from April 2001 to October 2008, where she alsoserved on firm’s equity capital markets management team over that timeframe, and held the position of Associate Director of Researchat ING Barings LLC (USA) from September 2000 to February 2001 (acquired by ABNAMRO 2001), and was the Director of US Research at CreditLyonnais from April 1998 to September 2000 (acquired by Credit Agricole 2003). Her background in equity securities research has provideda deep base of knowledge and experience in pharmaceutical, biotech, and med-tech companies. She has been recognized by the Wall StreetJournal’s “Best on the Street” All-Star Analyst Survey. Ms. Valauri has been the founder and CEO of Sagestone Advisory,LLC since July 2017, where she is also a business strategy consultant. Ms. Valauri currently serves as an Entrepreneur In Residence atWeill Cornell Medicine BioVenture eLab, since July 2023 and a Senior Mentor since April 2021. She is an advisor to early stage privateand public companies and has been an angel investor for over 20 years. Ms. Valauri also currently serves on the board of Precipio, Inc.(NYSE: PRPO), a specialty cancer diagnostics company. Ms. Valauri earned her B.A. in Biology from Reed College, and an MBA from CornellUniversity Johnson School of Management Class of 2020.
Family Relationships
There are no family relationships amongany of our directors or executive officers.
Corporate Governance
Composition of our Board of Directors
Our business and affairs are managed underthe direction of our board of directors (“Board”). The number of directors will be fixed by our Board, subject to the termsof our Charter and Bylaws, which include a requirement that the number of directors be fixed exclusively by a resolution adopted by directorsconstituting a majority of the total number of authorized directors, whether or not there exist any vacancies in previously authorizeddirectorships. The size of our Board is currently fixed at five directors, with one vacancy.
When considering whether directors andnominees have the experience, qualifications, attributes or skills, taken as a whole, to enable our Board to satisfy its oversight responsibilitieseffectively in light of our business and structure, the Board focuses primarily on each person’s background and experience as reflectedin the information discussed in each of the directors’ individual biographies set forth above. We believe that our directors providean appropriate mix of experience and skills relevant to the size and nature of our business.
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Corporate Governance Profile
As set forth in our Charter and Bylaws,our corporate governance is structured in a manner we believe closely aligns our interests with those of our stockholders. Notable featuresof our corporate governance structure include the following:
· | a majority of our directors satisfy the Nasdaq listingstandards for independence; | |
· | generally, all matters to be voted on by stockholders will be approved by a majority(or, in the case of election of directors, by a plurality) of the votes entitled to be cast by all stockholders present in person or representedby proxy, voting together as a single class; | |
· | we comply with the requirements of Nasdaq rules, including having committees comprisedsolely of independent directors; and | |
· | we do not have a stockholder rights plan. |
Our directors stay informed about ourbusiness by attending meetings of our Board and its committees and through supplemental reports and communications. Our independent directorsmeet regularly in executive sessions without the presence of our corporate officers or non-independent directors.
Classified Board
In accordance with the terms ofour Charter, our Board is divided into three staggered classes, and each of our directors is assigned to one of the three classes,Class I, Class II and Class III. Each class of directors is elected for a three-year term, provided that the first term for eachclass of directors will expire as set forth below. Currently, our directors are divided among the three classes as follows:
· | the Class I directors are Christina Valauri and Karen Drexler, and their current term will expire atour 2025 annual meeting of stockholders; | |
· | the Class II director is Dean Zikria, and his current term will expire at our 2026 annual meeting; and | |
· | the Class III directors are Sheryle Bolton andJennifer Ernst, and their initial terms will expire at our 2027 annual meeting of stockholders. |
The division of our Board into three classeswith staggered three-year terms may delay or prevent a change of our management or a change in control of our company.
Leadership Structure and RiskOversight
Currently, Ms. Ernst serves as our ChiefExecutive Officer and Ms. Bolton serves as Chair of our Board. The Board does not have a policy regarding the separation of the rolesof Chief Executive Officer and Chair of the Board, as our Board believes it is in the best interest of the Company to make that determinationbased on the position and direction of the Company and the membership of the Board.
The Board actively manages the Company’srisk oversight process and receives periodic reports from management on areas of material risk to the Company, including operational,financial, legal, and regulatory risks. The Board committees will assist the Board in fulfilling its oversight responsibilities in certainareas of risk. The Audit and Risk Committee assists the Board with its oversight of the Company’s major financial risk exposures.The Compensation Committee assists the Board with its oversight of risks arising from the Company’s compensation policies and programs.The Nominations and Corporate Governance Committee assists the Board with its oversight of risks associated with board organization, boardindependence, and corporate governance. While each committee is responsible for evaluating certain risks and overseeing the managementof those risks, the entire Board will continue to be regularly informed about the risks.
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Director Independence
The Nasdaq rules require that, subjectto specified exceptions, each member of a listed company’s audit, compensation and nominations committees be independent, or, ifa listed company has no nominations committee, that director nominees be selected or recommended for the board’s selection by independentdirectors constituting a majority of the board’s independent directors. The Nasdaq rules further require that audit committee memberssatisfy independence criteria set forth in Rule 10A-3 under the Exchange Act and that compensation committee members satisfy the independencecriteria set forth in Rule 10C-1 under the Exchange Act.
Our Board has undertaken a review of theindependence of our directors and considered whether any director has a material relationship with us that could compromise that director’sability to exercise independent judgment in carrying out that director’s responsibilities. Our Board has affirmatively determinedthat each of Dean Zikria, Sheryle Bolton, Christina Valauri and Karen Drexler qualify as an independent director, as defined under theapplicable corporate governance standards of Nasdaq. These rules require that our Audit and Risk Committee be composed of at least threedirectors, all of whom must be independent members.
Board Committees
The Board has threestanding committees, the Audit and Risk Committee, the Compensation Committee, and the Nominations and Corporate GovernanceCommittee, to assist it with the performance of its responsibilities. The Board designates the members of these committees and thecommittee chairs based on the recommendation of the Nominations and Corporate Governance Committee. The Board has adopted writtencharters for each of these committees, all of which can be found on our corporate website at https://tivichealth.com/investor/. Thechair of each committee develops the agenda for that committee and determines the frequency and length of committee meetings.
Audit and Risk Committee
Our Board has established anAudit and Risk Committee which consists of four independent directors, Dean Zikria, Sheryle Bolton, Christina Valauri and KarenDrexler, with Sheryle Bolton serving as the Chairperson. The Board has determined that each member of the Audit and Risk Committeemeets the independence requirements of Rule 10A-3 of the Exchange Act, and the applicable rules of Nasdaq, and has sufficientknowledge in financial and auditing matters to serve on the Audit and Risk Committee. The committee’s primary dutiesinclude:
· | selecting a firm to serve as the independent registered public accounting firm toaudit our financial statements; | |
· | reviewing and discussing with management and our independent auditor our annualand quarterly financial statements and related disclosures, including disclosure under “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and the results of the independent auditor’s audit or review, as the casemay be; | |
· | reviewing our financial reporting processes and internal control over financialreporting systems and the performance, generally, of our internal audit function; | |
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· | overseeing the audit and other services of our independent registered public accountingfirm and being directly responsible for the appointment, independence, qualifications, compensation and oversight of the independent registeredpublic accounting firm, which reports directly to the Audit and Risk Committee; | |
· | providing an open means of communication among our independent registered publicaccounting firm, management, our internal auditing function and our Board; | |
· | reviewing any disagreements between our management and the independent registeredpublic accounting firm regarding our financial reporting; | |
· | preparing the Audit and Risk Committee report for inclusion in our proxy statementfor our annual stockholder meetings; | |
· | establishing procedures for complaints received regarding our accounting, internalaccounting control and auditing matters; | |
· | overseeing the Company’s enterprise risk managementprocess; and | |
· | approving all audit and permissible non-audit services conducted by our independentregistered public accounting firm. |
The Board has determined that SheryleBolton is an “audit committee financial expert,” as that term is defined in the rules promulgated by the SEC pursuant to theSarbanes-Oxley Act. The Board has further determined that each of the members of the Audit and Risk Committee is financially literateand that at least one member of the committee has accounting or related financial management expertise, as such terms are interpretedby the Board in its business judgment.
Compensation Committee
Our Board has established aCompensation Committee which consists of four independent directors (as defined under the general independence standards of Nasdaqand our Corporate Governance Guidelines): Dean Zikria, Sheryle Bolton, Christina Valauri and Karen Drexler are each a“non-employee director” (within the meaning of Rule 16b-3 of the Exchange Act). Karen Drexler serves as Chairperson ofthe Compensation Committee and Sheryle Bolton will serve as interim chairperson upon Ms. Drexler’s resignation as of September30, 2024. The committee’s primary duties include:
· | reviewing all overall compensation policies and practices; | |
· | administering the Company’s compensation recovery policy; | |
· | approving corporate goals and objectives relevant to executive officer compensation and evaluate executiveofficer performance in light of those goals and objectives; | |
· | determining and approving executive officer compensation, including base salary and incentive awards; | |
· | reviewing and approving, or making recommendations to the Board regarding, compensation plans; | |
· | administering our equity incentive plan, subject to Board approval; and | |
· | reviewing succession planning for key executives. |
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Our Compensation Committee determinesand approves elements of executive officer compensation, except that compensation of our chief executive officer and chief financial officerwill be subject to review and approval by the Board. It also provides recommendations to the Board with respect to non-employee directorcompensation. The Compensation Committee may not delegate its authority to any other person, other than to a subcommittee.
Nominations and Corporate GovernanceCommittee
Our Board has also established a Nominationsand Corporate Governance Committee which consists of Dean Zikria, Christina Valauri, Sheryle Bolton and Karen Drexler, with ChristinaValauri serving as Chairperson. The committee’s primary duties include:
· | recruiting new directors, consider director nominees recommended by stockholders and others and recommendnominees for election as directors; | |
· | reviewing the size and composition of our Board and committees; | |
· | overseeing the evaluation of the Board; | |
· | recommending actions to increase the Board’s effectiveness; and | |
· | developing, recommending and overseeing our corporate governance principles, including our Code of Business Conduct and Ethics andour Corporate Governance Guidelines. |
Legal Proceedings
To our knowledge, (i) no director or executiveofficer has been a director or executive officer of any business that has filed a bankruptcy petition or had a bankruptcy petition filedagainst it during the past ten years; (ii) no director or executive officer has been convicted of a criminal offense or is the subjectof a pending criminal proceeding during the past ten years; (iii) no director or executive officer has been the subject of any order,judgment or decree of any court permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in anytype of business, securities or banking activities during the past ten years; and (iv) no director or officer has been found by a courtto have violated a federal or state securities or commodities law during the past ten years.
Code of Business Conduct and Ethics
We have adopted a Code of Business Conductand Ethics that applies to all of our employees, officers and directors, including those officers responsible for financial reporting.Our Code of Business Conduct and Ethics is available on our corporate website at https://tivichealth.com/investor/. We intend to discloseany amendments to the code, or any waivers of its requirements, on our corporate website or in a Current Report on Form 8-K.
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EXECUTIVE AND DIRECTOR COMPENSATION
Summary Compensation Table
The following table sets forth, for the fiscal years endedDecember 31, 2023 and December 31, 2022, the dollar value of all cash and noncash compensation earned by our named executive officers,as set forth above.
Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($)(1) | All Other Compensation ($)(2) | Totals ($) | ||||||||||||||||
Jennifer Ernst, | 2023 | 275,000 | – | 15,393 | 38,947 | 329,340 | ||||||||||||||||
CEO and Director | 2022 | 275,000 | – | 123,320 | 20,901 | 419,221 | ||||||||||||||||
Blake Gurfein, PhD | 2023 | 303,409 | 40,625 | 12,315 | 48,672 | 405,021 | ||||||||||||||||
Chief Scientific Officer | 2022 | 275,000 | 50,938 | 29,038 | 29,926 | 384,902 | ||||||||||||||||
Ryan Sabia (3) | 2023 | 229,167 | 10,000 | 12,315 | 33,759 | 285,241 | ||||||||||||||||
Chief Operating Officer | 2022 | 254,205 | 24,750 | 41,484 | 16,994 | 337,433 |
(1) | Amounts shown in the “Option Awards” column represent the aggregategrant date fair value of stock options. These amounts represent the grant date fair value of stock options granted in fiscal 2023 and2022 computed in accordance with FASB ASC Topic 718. We do not include any impact of estimated forfeitures related to service-based vestingterms in these calculations. | |
(2) | Includes the cost of health insurance coverage and benefits paid by the Companyfor each named executive officer that is not reimbursed. | |
(3) | On January 22, 2024, Ryan Sabia was terminated as an employee and Chief Operating Officer of the Company. |
Narrative to the summary compensationtable
Employment Agreements/Arrangements
As of the year ended December 31, 2023,we had executive offer letters in place with Jennifer Ernst, our Chief Executive Officer; Blake Gurfein, our Chief Science Officer; andRyan Sabia, our Chief Operating Officer, as well as a consulting agreement with Kimberly Bambach, our Interim Chief Financial Officer.A summary of the terms is set forth below.
Currently, the annual compensation ofeach of our executive officers is determined by the Board. The named executive officers are also entitled to participate in the Company’sbenefit plans, which benefits are generally available to all full-time employees.
Executive Offer Letter with JenniferErnst
On July 31, 2021, weentered into an executive offer letter with Jennifer Ernst. Pursuant to her executive offer letter, effective July 31, 2021, Ms.Ernst is entitled to a base salary of $275 thousand and, commencing with the 2022 calendar year (payable in the first quarter of2023), will be eligible to receive, at the sole discretion of the Board, an annual end-of-year incentive bonus in an amount up to40% of her base salary. The annual end-of-year incentive bonus, if earned, will be determined by the Board, in its sole discretion,and will be dependent upon the achievement of certain Company milestones and profitability, and such other milestones as the Boarddeems appropriate.
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Ms. Ernst’semployment is “at will,” meaning that either she or the Company are entitled to terminate Ms. Ernst’s employmentat any time and for any reason, with or without cause. In the event that her employment with the Company is terminated for anyreason before December 31 of any given year, she will not be entitled to receive an annual end-of-year bonus. In the event that (i)Ms. Ernst elects to terminate her employment with the Company other than for good reason, (ii) the Company terminates her employmentfor cause, or (iii) her employment is terminated as a result of her death of complete disability, then Ms. Ernst will not beentitled to receive any separation benefits. In the event that Ms. Ernst terminates her employment for good reason or the Companyterminates her employment without cause, Ms. Ernst shall be entitled to receive 1/12 of her base salary for a period of six monthsafter termination.
Executive Offer Letter with BlakeGurfein
In January 2018, we entered into a standardat will offer with Blake Gurfein, which was amended in part in February 2019. Pursuant to his offer letter, Mr. Gurfein is entitled toa base salary of $350 thousand per annum and, will be eligible to receive, at the sole discretion of the Board, an annual end-of-yearincentive bonus in an amount up to 25% of his base salary. The annual end-of-year incentive bonus, if earned, will be determined by theBoard, in its sole discretion, and will be based on subjective or objective criteria, as approved by the Board.
Mr. Gurfein’s employment is “atwill,” meaning that either he or the Company are entitled to terminate Mr. Gurfein’s employment at any time and for any reason,with or without cause. In the event that his employment with the Company is terminated for any reason before December 31 of any givenyear, he will not be entitled to receive an annual end-of-year bonus. In the event that Mr. Gurfein’s employment terminates as aresult of an involuntary Separation of Service (as defined in the regulations interpreting Section 409A of the Internal Revenue Code),other than for cause, Mr. Gurfein will be eligible to receive his full base salary for a period of six months after termination, as wellas reimbursement for COBRA premiums him and his covered dependents for six months after termination. Notwithstanding the foregoing, suchseverance benefits shall be waived in the event that a Separation of Services occurs within 12 months of a change of control that resultsin proceeds to Mr. Gurfein of $2,000,000 or more.
Executive Offer Letter with RyanSabia
On April 1, 2022, we entered into an executiveoffer letter with Ryan Sabia. Pursuant to his executive offer letter, and prior to his termination in January 2024, Mr. Sabia was entitledto a base salary of $250 thousand per annum (subject to review and adjustment in accordance with the Company’s normal performancereview practices) and, commencing with the 2022 calendar year (payable in the first quarter of 2023), was eligible to receive, at thesole discretion of the Board, an annual end-of-year incentive bonus in an amount up to 25% of base salary. The annual end-of-year incentivebonus, if earned, was to be determined by the Board, in its sole discretion, and was to be dependent upon the achievement of certain Companymilestones and profitability, and such other milestones as the Board deems appropriate.
Mr. Sabia was terminated as an employeeand Chief Operating Officer of the Company. Mr. Sabia received salary and benefits earned by him through his termination date, and wasnot entitled to, and did not receive, any separation benefits in connection with his termination. Additionally, all outstanding optionsto purchase Company common stock held by Mr. Sabia as of his termination date terminated.
Agreement with Kimberly Bambach
Kimberly Bambach was appointed as theCompany’s Interim Chief Executive Officer, effective April 28, 2023, and was retained to provide such services as a non-employeeconsultant pursuant to a consulting agreement. Pursuant to such agreement, Ms. Bambach is entitled to receive $200 per hour for servicesprovided in her capacity as Interim Chief Financial Officer. The agreement shall remain effective until such time as it is terminatedby either party.
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Outstanding Equity Awards atFiscal Year-End 2023
The following table provides informationregarding the outstanding equity awards held by our named executive officers as of December 31, 2023. See “Equity Incentive Plan Information,” below, for additional information regarding our equity incentive plans.
Name | Number of Securities Underlying Unexercised Options (#) Exercisable | Number of Securities Underlying Unexercised Options (#) Unexercisable | Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#) | Option Exercise Price ($) | Option Expiration Date | Number of Shares of Stock That Have Not Vested (#) | Market Value of Shares of Stock That Have Not Vested ($) | Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested (#) | Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested (#) | ||||||||||||
Jennifer Ernst | 575 | – | – | $ | 13.20 | 4/1/2028 | – | – | – | – | |||||||||||
917 | 1,083 | (1) | – | $ | 183.00 | 2/4/2027 | – | – | – | – | |||||||||||
– | 1,250 | (2) | – | $ | 13.00 | 5/8/2033 | – | – | – | – | |||||||||||
Blake Gurfein | 413 | 412 | (3) | – | $ | 459.00 | 12/14/2031 | – | – | – | – | ||||||||||
79 | – | – | $ | 12.00 | 4/3/2028 | – | – | – | – | ||||||||||||
53 | – | – | $ | 12.00 | 6/27/2028 | – | – | – | – | ||||||||||||
162 | 188 | (4) | – | $ | 167.00 | 2/4/2032 | – | – | – | – | |||||||||||
– | 1,000 | (2) | – | $ | 13.00 | 5/8/2033 | – | – | – | – | |||||||||||
Ryan Sabia(6) | 345 | 155 | (5) | – | $ | 160.00 | 6/17/2031 | – | – | – | – | ||||||||||
126 | 124 | (3) | – | $ | 459.00 | 12/14/2031 | – | – | – | – | |||||||||||
230 | 270 | (1) | – | $ | 167.00 | 2/4/2032 | – | – | – | – | |||||||||||
– | 1,000 | (2) | – | $ | 13.00 | 5/8/2033 | – | – | – | – |
(1) | The options vest as follows: (i) 25% on February 4, 2023, and (ii) the remaining75% in equal installments over the next 36 months. | |
(2) | The options vest as follows: (i) 25% on May 8, 2024, and (ii) the remaining 75%in equal installments over the next 36 months. | |
(3) | The options vest as follows: (i) 25% on December 14, 2022, and (ii) the remaining75% in equal monthly installments over the next 36 months. | |
(4) | The options vest as follows: (i) 25% on February 4, 2022, and (ii) the remaining75% in equal monthly installments over the next 36 months. | |
(5) | The options vest as follows: (i) 25% on March 1, 2022, and (ii) the remaining 75%in equal monthly installments over the next 36 months. | |
(6) | As noted above, Mr. Sabia was terminated as an employee of the Company on January22, 2024. In connection with his termination, all of the outstanding stock options held by Mr. Sabia as of that date terminated. |
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Equity Incentive Plan Information
The following table provides information as of December 31, 2023,regarding our equity compensation plans:
Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights | Weighted- average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance under equity compensation plans | |||||||||
Equity compensation plans approved by security holders (1) | 14,661 | $ | 144.41 | 7,190 | ||||||||
Equity compensation plans not approved by security holders | – | – | – | |||||||||
Total | 14,661 | $ | 144.41 | 7,190 |
(1) | Represents outstanding stock options granted to our current or former employees, directors and consultants pursuant to the 2017 Equity Incentive Plan (the “2017 Plan”) and 2021 Equity Incentive Plan (the “2021 Plan”). |
2017 Equity Incentive Plan
The Board adopted the 2017 Plan on April13, 2017. The principal purpose of the 2017 Plan was to attract, retain and motivate selected employees, consultants and directors throughthe granting of stock-based compensation awards and cash-based performance bonus awards. The material terms of the 2017 Plan are summarizedbelow. In August 2021, the Board adopted and our stockholders approved the 2021 Plan, which became effective upon the completion of ourIPO. Upon the effectiveness of the 2021 Plan, it replaced the 2017 Plan, except with respect to awards outstanding under the 2017 Plan,and no further awards are available for grant under the 2017
Plan.
Share reserve. Under the 2017 Plan,9,813 shares of our common stock were reserved for issuance pursuant to a variety of stock-based compensation awards, including stockoptions, restricted stock awards, and other stock- based awards. With respect to the share reserve under the 2017 Plan:
· | to the extent that an award terminated, expired or lapsed for any reason or an awardwas settled in cash without the delivery of shares prior to the effectiveness of the 2021 Plan, any shares subject to the award at suchtime would have been available for future grants under the 2017 Plan; and | |
· | prior to the effectiveness of the 2021 Plan, to the extent that shares of our commonstock were repurchased by us prior to vesting so that shares were returned to us, such shares would have been available for future grantsunder the 2017 Plan. |
As noted above, upon the effectivenessof the 2021 Plan, it replaced the 2017 Plan, except with respect to awards outstanding under the 2017 Plan, and no further awards areavailable for grant under the 2017 Plan.
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Administration. Following completionof our IPO, the Compensation Committee of the Board began administering the 2017 Plan. Prior to that, the 2017 Plan was administered bythe Board.
Subject to the terms and conditions ofthe 2017 Plan, the administrator has the authority to select the persons to whom awards are to be made, to determine the number of sharesto be subject to awards and the terms and conditions of awards, and to make all other determinations and to take all other actions necessaryor advisable for the administration of the 2017 Plan. The administrator is also authorized to adopt, amend or rescind rules relating toadministration of the 2017 Plan. The Board may at any time remove the Compensation Committee as the administrator and revest in itselfthe authority to administer the 2017 Plan.
Eligibility. Options, restrictedstock and all other stock-based and cash-based awards under the 2017 Plan may be granted to individuals who are then our officers, employeesor consultants or are the officers, employees or consultants of certain of our subsidiaries. Such awards also may be granted to our directors.Only employees of our company may be granted incentive stock options (“ISOs”).
Awards. The 2017 Plan providesthat the administrator may grant or issue stock options, restricted stock, other stock- or cash-based awards and dividend equivalents,or any combination thereof; provided, however, that as noted above, no additional awards may be issued under the 2017 Plan. Each awardwill be set forth in a separate agreement with the person receiving the award, which will indicate the type, terms and conditions of theaward.
· | Incentive stock options. ISOs will be designed in a manner intended to comply withthe provisions of Section 422 of the Code and will be subject to specified restrictions contained in the Code. Among such restrictions,ISOs must have an exercise price of not less than the fair market value of a share of common stock on the date of grant, may only be grantedto employees, and must not be exercisable after a period of ten years measured from the date of grant. In the case of an ISO granted toan individual who owns (or is deemed to own) at least 10% of the total combined voting power of all classes of our capital stock, the2017 Plan provides that the exercise price must be at least 110% of the fair market value of a share of common stock on the date of grantand the ISO must not be exercisable after a period of five years measured from the date of grant. | |
· | Nonstatutory stock options. Nonstatutory Stock Options, or NSOs, will provide forthe right to purchase shares of our common stock at a specified price which may not be less than fair market value on the date of grant,and usually will become exercisable (at the discretion of the administrator) in one or more installments after the grant date, subjectto the participant’s continued employment or service with us and/ or subject to the satisfaction of corporate performance targetsand individual performance targets established by the administrator. NSOs may be granted for any term specified by the administrator thatdoes not exceed ten years. | |
· | Restricted stock. Restricted stock may be granted to any eligible individual andmade subject to such restrictions as may be determined by the administrator. Restricted stock, typically, may be forfeited for No considerationor repurchased by us at the original purchase price if the conditions or restrictions on vesting are not met. In general, restricted stockmay not be sold or otherwise transferred until restrictions are removed or expire. Purchasers of restricted stock, unlike recipients ofoptions, will have voting rights and will have the right to receive dividends, if any, prior to the time when the restrictions lapse,however, extraordinary dividends will generally be placed in escrow, and will not be released until restrictions are removed or expire. | |
· | Other stock-based awards. Other stock-based awards are awards of fully vested sharesof our common stock and other awards valued wholly or partially by referring to, or otherwise based on, shares of our common stock. |
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Other stock-based awards may be grantedto participants and may also be available as a payment form in the settlement of other awards, as standalone payments and as payment inlieu of base salary, bonus, fees or other cash compensation otherwise payable to any individual who is eligible to receive awards. Theplan administrator will determine the terms and conditions of other stock-based awards, which may include vesting conditions based oncontinued service, performance and/or other conditions.
Any award may be granted as a performanceaward, meaning that the award will be subject to vesting and/or payment based on the attainment of specified performance goals.
Change incontrol. In the event of a change in control, to the extent that an award (i) is vested, (ii) the terms of an award provide foracceleration of vesting upon a change in control, or (iii) the administrator elects to accelerate the vesting of the award inconnection with the change in control, the plan administrator may elect to provide for the purchase or exchange of an award for cashor other property in an amount equal to the difference between (x) the value of cash or other property the optionee would receive inconnection with such change in control if the optionee exercised the award, and (y) the aggregate exercise price of the vestedportion of the award. If the award is not purchased or exchanged as provided above, then the award will be terminated and cease tobe exercisable unless the award is expressly assumed or substituted by the acquirer.
Adjustments ofawards. In the event of any stock dividend or other distribution, stock split, reverse stock split, reorganization, combinationsor exchange of share, merger, consolidation, split-up, spin off, recapitalization, repurchase or any other corporate event affectingthe number of outstanding shares of our common stock or the share price of our common stock that would require adjustments to the2017 Plan or any awards under the 2017 Plan in order to prevent the dilution or enlargement of the potential benefits intended to bemade available thereunder, the administrator will make appropriate, proportionate adjustments to: (i) the aggregate number and typeof shares subject to the 2017 Plan; (ii) the number and kind of shares subject to outstanding awards and terms and conditions ofoutstanding awards (including, without limitation, any applicable performance targets or criteria with respect to such awards); and(iii) the grant or exercise price per share of any outstanding awards under the 2017 Plan. In connection with the 1-for-4 reversestock split of our issued and outstanding shares of common stock that was effected on August 31, 2021, the terms of certain awardsgranted under our 2017 Plan were equitably adjusted in accordance with the provisions thereof.
Amendment and termination. Theadministrator may terminate, amend or modify the 2017 Plan at any time and from time to time. However, we must generally obtain stockholderapproval to amend or modify the 2017 Plan to the extent required by applicable law, rule or regulation (including any applicable stockexchange rule). Notwithstanding the foregoing, an option may be amended to reduce the per share exercise price below the per share exerciseprice of such option on the grant date and options may be granted in exchange for, or in connection with, the cancellation or surrenderof options having a higher per share exercise price without receiving additional stockholder approval.
No ISOs may be grantedpursuant to the 2017 Plan after the tenth anniversary of the effective date of the 2017 Plan. Any award that is outstanding on thetermination date of the 2017 Plan will remain in force according to the terms of the 2017 Plan and the applicable awardagreement.
Amended and Restated2021 Equity Incentive Plan
In August 2021, the Board adopted andour stockholders approved the 2021 Plan, which became effective upon the completion of our IPO. Upon the effectiveness of the 2021 Plan,it replaced the 2017 Plan, except with respect to awards outstanding under the 2017 Plan, and no further awards may be made under the2017 Plan. Additionally, any awards that are canceled or expire under the 2017 Plan will not be reissued. The principal purpose of the2021 Plan is to attract, retain and incentivize the Company’s employees and other service providers through the granting of certainstock-based awards, including performance-based awards. The material terms of the 2021 Plan, as it is currently contemplated, are summarizedbelow.
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On June 15, 2024, the Board unanimously approved theadoption of an Amended and Restated 2021 Equity Incentive Plan (the “A&R 2021 Plan”), and directed that the A&R 2021Plan be submitted to our stockholders for their approval at the 2024 Annual Meeting. On August 9, 2024, the stockholders approved theA&R 2021 Plan.
Description of the A&R 2021 Plan
The principal provisions of the A&R 2021 Planare summarized below. This summary is not a complete description of all of the A&R 2021 Plan’s provisions and is qualified inits entirety by reference to the full text of the 2021 A&R Plan, a copy of which is attached hereto as an exhibit.
Purpose of the A&R 2021 Plan
The purpose of the A&R 2021 Plan is to (i) provideadditional incentive for selected Employees, Directors and Consultants to further the growth, development and financial success of theCompany by providing a means by which such persons can personally benefit through the ownership of capital stock of the Company, and (ii)enable the Company to secure and retain key Employees, Directors and Consultants considered important to the long-term success of theCompany by offering such persons an opportunity to own capital stock of the Company.
Share reserve. Under the A&R 2021 Plan,1,000,000 shares of our Common Stock shall initially be reserved for issuance pursuant to a variety of stock-based compensation awards,including stock options, restricted stock awards, restricted stock units, stock bonus awards and performance-based awards as of the dateof its adoption by the Company. With respect to the share reserve under the A&R 2021 Plan:
· | to the extent that an award terminates, expires or lapses for any reason or an award is settled in cashwithout the delivery of shares, any shares subject to the award at such time will be available for future grants under the A&R 2021Plan; and | |
· | to the extent that shares of our Common Stock are repurchased by us at the original purchase price, suchshares will be available for future grants under the A&R 2021 Plan. |
In addition, the A&R 2021 Plan provides that additionalshares will automatically be added to the shares authorized for issuance under the A&R 2021 Plan on January 1 of each year. The numberof shares added each year will be equal to the lesser of: (i) 5.0% of the shares of Common Stock outstanding on December 31st of the precedingcalendar year or (ii) such number of shares determined by the Board, in its discretion.
Administration. The Compensation Committeeof the Board is authorized to administer the A&R 2021 Plan unless the Board subsequently assumes authority for administration. TheCompensation Committee must consist of at least two members of the Board, each of whom is intended to qualify as a “non-employeedirector” for purposes of Rule 16b-3 under the Exchange Act and an “independent director” within the meaning of therules of the applicable stock exchange, or other principal securities market on which shares of our Common Stock are traded. The termAdministrator refers to either the Board or the Compensation Committee, as applicable.
Additionally, the Board or Compensation Committeemay delegate certain functions under the A&R 2021 Plan to designate employees who are not Officers to be recipients of awards underthe A&R 2021 Plan, and to determine the number of shares subject to awards granted to such employees.
Subject to the terms and conditions of the A&R2021 Plan, the Administrator has the authority to construe and interpret the A&R 2021 Plan and awards granted under it and to determinethe persons to whom and the dates on which awards will be granted, the number of shares of Common Stock to be subject to each award, thetime or times during the term of each award within which all or a portion of such award may be exercised, the exercise price, the typeof consideration and other terms of the award. All decisions, determinations and interpretations by the Administrator regarding the A&R2021 Plan shall be final and binding on all participants or other persons claiming rights under the A&R 2021 Plan or any award.
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Awards. The A&R 2021 Plan provides thatthe Administrator may grant or issue stock options, restricted stock, restricted stock units, other stock-based awards and dividend equivalents,or any combination thereof. Each award will be set forth in a separate agreement with the person receiving the award and will indicatethe type, terms and conditions of the award.
Eligibility. Options, restricted stock, restrictedstock units and all other stock-based awards under the A&R 2021 Plan may be granted to individuals who are then our officers, employees,directors or consultants or are the officers, employees or consultants of certain of our subsidiaries. Only employees of our company orcertain of our subsidiaries may be granted incentive stock options, or ISOs. No ISO may be granted under the A&R 2021 Plan to anyperson who, at the time of the grant, owns (or is deemed to own) stock possessing more than 10% of the total combined voting power ofthe Company or any affiliate of the Company, unless the exercise price is at least 110% of the fair market value of the stock subjectto the option on the date of grant and the term of the option does not exceed five years from the date of grant. In addition, the aggregatefair market value, determined at the time of grant, of the shares of Common Stock with respect to which ISOs are exercisable for the firsttime by a participant during any calendar year (under the A&R 2021 Plan and all other such plans of the Company and its affiliates)may not exceed $100,000. ISOs are not transferable except by will or by the laws of descent and distribution, provided that a participantmay designate a beneficiary who may exercise an option following the participant’s death.
· | Stock Options. Options granted under the A&R 2021 Plan may become exercisable in cumulativeincrements (“vest”) as determined by the Administrator. Such increments may be based on continued service to the Company overa certain period of time, the occurrence of certain performance milestones, or other criteria. Options granted under the A&R 2021Plan may be subject to different vesting terms. |
To the extent provided by the terms ofan option, a participant may satisfy any federal, state or local tax withholding obligation relating to the exercise of such option bya cash payment upon exercise, by authorizing the Company to withhold a portion of the stock otherwise issuable to the participant, orby such other method as may be set forth in the option agreement. The maximum term of options under the A&R 2021 Plan is 10 years,except that in certain cases (see Eligibility) the maximum term of certain incentive stock options is five years. Options under the A&R2021 Plan generally terminate sixty (60) days after termination of the participant’s service unless (i) such termination is dueto the participant’s disability, in which case the option may, but need not, provide that it may be exercised at any time within6 months of such termination; (ii) the participant dies before the participant’s service has terminated, or within three monthsafter termination of such service, in which case the option may, but need not, provide that it may be exercised within 12 months of theparticipant’s death by the person or persons to whom the rights to such option pass by will or by the laws of descent and distribution;or (iii) the option by its terms specifically provides otherwise. If an optionee’s service with the Company, or any affiliate ofthe Company, ceases with cause, the option will terminate at the time the optionee’s service ceases. In no event may an option beexercised after its expiration date.
· | Stock Bonuses and Restricted Stock Awards. Stock bonus awards and restricted stock awards are grantedthrough a stock bonus award agreement or restricted stock award agreement. The purchase price for a stock purchase award (if any) maybe payable in cash, or any other form of legal consideration approved by the Administrator. Stock bonus awards may be granted in considerationfor the recipient’s past services for the Company. Common Stock issued under a restricted stock or stock bonus award agreement maybe subject to a share repurchase option or forfeiture right in our favor, each in accordance with a vesting schedule and subject to theminimum vesting requirement. If a recipient’s service relationship with us terminates, we may reacquire or receive via forfeitureall of the shares of our Common Stock issued to the recipient pursuant to a restricted stock or stock bonus award that have not vestedas of the date of termination. Rights under a stock bonus or restricted stock bonus agreement may be transferred only as expressly authorizedby the terms of the applicable stock bonus or restricted stock purchase agreement. | |
· | Restricted Stock Units. Restricted stock unit awards are issued pursuant to a restricted stockunit award agreement. The consideration for a stock unit award shall be determined by the Administrator and may be payable in any formacceptable to the Administrator and permitted under applicable law. The Administrator may impose any restrictions or conditions upon thevesting of restricted stock unit awards, or that delay the delivery of the consideration after the vesting of stock unit awards, thatit deems appropriate consistent with the minimum vesting requirement. Restricted stock unit awards may be settled in cash or shares ofthe Company’s Common Stock, as determined by the Administrator. No dividends payments will be made on unvested restricted stockunit awards, but instead any dividends will be deferred until awards become vested. If a restricted stock unit award recipient’sservice relationship with the Company terminates, any unvested portion of the restricted stock unit award is forfeited upon the recipient’stermination of service. |
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· | Performance-Based Award. Any award may be granted as a performance award, meaning that the awardwill be subject to vesting and/or payment based on the attainment of specified performance goals. Generally, such pre-established performancegoals consist of one or more business criteria and a targeted performance level with respect to such criteria as a condition of awardsbeing granted or becoming exercisable, or as a condition to accelerating the timing of such events. Performance may be measured over aperiod of any length specified by the Administrator. |
Certain Corporate Transactions. In the eventof a merger, sale of all or substantially all of the assets of the Company or other change of control transaction, unless otherwise determinedby the Board, all outstanding awards will be subject to the agreement governing such merger, asset sale or other change of control transaction.Such agreement need not treat all such awards in an identical manner, and it will provide for one or more of the following with respectto each award: (i) the continuation of the award, (ii) the assumption of the award, (iii) the substitution of the award, or (iv) the paymentof the excess of the fair market value of the shares subject to the award over the exercise price or purchase price of such shares. Inthe event the successor corporation refuses to either continue, assume or substitute the shares subject to the award pursuant to the termsof the A&R 2021 Plan, or pay the excess of the fair market value of the shares subject to the award over the exercise price or purchaseprice of such shares, then outstanding awards shall vest and become exercisable as to 100% of the shares subject thereto contingent uponthe consummation of such change of control transaction.
Adjustments Provisions. Transactions not involvingreceipt of consideration by the Company, such as a merger, consolidation, reorganization, recapitalization, reincorporation, reclassification,stock dividend, dividend in property other than cash, stock split, liquidating dividend, combination of shares, exchange of shares, ora change in corporate structure may change the type(s), class(es) and number of shares of Common Stock subject to the A&R 2021 Planand outstanding awards. In that event, the A&R 2021 Plan will be appropriately adjusted as to the type(s), class(es) and the maximumnumber of shares of Common Stock subject to the A&R 2021 Plan, and outstanding awards will be adjusted as to the type(s), class(es),number of shares and price per share of Common Stock subject to such awards.
Amendment and termination. The administratormay terminate, amend or modify the A&R 2021 Plan at any time and from time to time. However, we must generally obtain stockholderapproval to amend or modify the A&R 2021 Plan to the extent required by applicable law, rule or regulation (including any applicablestock exchange rule). Notwithstanding the foregoing, an option may be amended to reduce the per share exercise price below the per shareexercise price of such option on the grant date and options may be granted in exchange for, or in connection with, the cancellation orsurrender of options having a higher per share exercise price without receiving additional stockholder approval.
New Plan Benefits
At the present time, no specific determination hasbeen made as to the grant or allocation of future awards under the A&R 2021 Plan. Awards granted under the A&R 2021 Plan are withinthe Board’s and the Compensation Committee’s discretion, and neither the Board nor the Compensation Committee has determinedfuture awards or who might receive them. Therefore, at this time, the benefits that will be awarded or paid under the A&R 2021 Plan,if stockholder approval of the A&R 2021 Plan is obtained, cannot currently be determined. The A&R 2021 Plan does not have setbenefits or amounts, and no grants or awards have been made by the Board or the Compensation Committee that are conditioned upon stockholderapproval of the A&R 2021 Plan.
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The following table sets forth informationregarding the compensation awarded to, earned by, or paid to our non-employee directors who served on our Board for the year ended December31, 2023.
Name | Fees earned or paid in cash ($)(1) | Stock awards ($) | Option awards ($)(2)(3) | Non-equity incentive plan compensation ($) | Nonqualified deferred compensation earnings ($) | All other compensation ($) | Total ($) | |||||||||||||||||||||
Sheryle Bolton | 63,000 | – | 2,121 | – | – | – | 65,121 | |||||||||||||||||||||
Karen Drexler | 50,000 | – | 2,121 | – | – | – | 52,121 | |||||||||||||||||||||
Dean Zikria | 35,000 | – | 2,121 | – | – | – | 37,121 |
(1) | These amounts reflect the cash payments that we made as compensation for Board services during fiscalyear 2023. | |
(2) | These amounts represent the grant date fair value of stock options granted in fiscal2023 computed in accordance with FASB ASC Topic 718. We do not include any impact of estimated forfeitures related to service-based vestingterms in these calculations. | |
(3) | As of December 31, 2023, the number of shares subject to all outstanding optionawards and stock awards held by our non-employee directors were as follows: |
Director | Number of Shares Subject to Option Awards | Number of Shares Subject to Stock Awards | ||||||
Sheryle Bolton | 893 | – | ||||||
Karen Drexler | 956 | – | ||||||
Dean Zikria | 893 | – |
On December 16, 2021, our Board, uponrecommendation of the Compensation Committee, approved an annual compensation plan for our Board (the “Board Compensation Plan”),which Board Compensation Plan is still in effect. In accordance with the Board Compensation Plan, directors of the Company will be entitledto receive the following annual compensation, which amounts will be paid in equal quarterly installments in accordance with our policies:
· | Annual Retainer for all Directors: $35,000 | |
· | Chairperson of the Board: $15,000 | |
· | Chairperson of the Audit and Risk Committee: $13,000 | |
· | Chairperson of the Compensation Committee: $9,000 | |
· | Chairperson of the Nominating and Governance Committee: $6,000 |
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MARKET PRICE OF AND DIVIDENDS ON THE COMPANY’SCOMMON STOCK
AND RELATED STOCKHOLDER MATTERS
Market Information
Our common stock, par value $0.0001 pershare, is listed on the Nasdaq Capital Market under the ticker symbol
“TIVC.”
Holders
As of August 12, 2024, there were approximately 98shareholders of record of our common stock. A substantially greater number of holders of our common stock are “street name”or beneficial holders, whose shares are held by banks, brokers, and other financial institutions.
Dividends
We have never declared or paid cash dividendson our capital stock. We currently intend to retain our future earnings, if any, for use in our business and therefore do not anticipatepaying cash dividends on our common stock in the foreseeable future. Payment of future dividends, if any, will be at the discretion ofour board of directors after taking into account various factors, including our financial condition, operating results, and current andanticipated cash needs. Investors should not purchase our common stock with the expectation of receiving cash dividends.
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SECURITY OWNERSHIP OF CERTAIN BENEFICIALOWNERS AND MANAGEMENT
The following table sets forth certain informationregarding the beneficial ownership of our outstanding common stock as of August 12, 2024 by: (i) each of our directors, (ii) each of ournamed executive officers (as defined by Item 402(a)(3) of Regulation S-K promulgated under the Exchange Act), and (iii) all of our directorsand named executive officers as a group. As of August 12, 2024, there are no persons known to us to beneficially own more than 5% of eachclass of our outstanding common stock. As of August 12, 2024, there were 6,183,592 shares of our common stock issued and outstanding.
Beneficial ownership has been determinedin accordance with Rule 13d-3 under the Exchange Act. The percentages in the table have been calculated on the basis of treating as outstandingfor a particular person, all shares of our common stock outstanding on that date and all shares of our common stock issuable to that holderin the event of exercise of outstanding options, warrants, rights or conversion privileges owned by that person at that date which areexercisable within 60 days of that date. Except as otherwise indicated, the persons listed below have sole voting and investment powerwith respect to all shares of our common stock owned by them, except to the extent that power may be shared with a spouse. The Companydoes not know of any arrangements the operation of which may at a subsequent date result in a change of control of the Company.
Beneficial owner (1) | Amount and Nature of Beneficial Ownership | Percent of Class | ||||||
Directors and Named Executive Officers | ||||||||
Jennifer Ernst (2) | 14,352 | * | ||||||
Kimberly Bambach | 7,500 | * | ||||||
Blake Gurfein, PhD (3) | 2,408 | * | ||||||
Christina Valauri (4) | 657 | * | ||||||
Dean Zikria (5) | 1,168 | * | ||||||
Sheryle Bolton (6) | 1,168 | * | ||||||
Karen Drexler (7) | 1,412 | * | ||||||
All directors and executive officers as a group (7 persons) | 28,665 | * |
* | Less than 1% | |
(1) | Unless otherwise indicated in the footnotes to the table, the address for each beneficial owner listed is c/o Tivic Health Systems, Inc., 47685 Lakeview Blvd., Fremont, CA 94538. | |
(2) | Includes 11,999 shares of common stock held by Ms. Ernst, and options to purchase 2,353 shares of common stock that are vested and exercisable (or will be vested and exercisable within 60 days of August 12, 2024). | |
(3) | Includes 1,120 shares of common stock held by Dr. Gurfein, as well as options to purchase 1,288 shares of common stock that are vested and exercisable (or will be vested and exercisable within 60 days of August 12, 2024). | |
(4) | Includes options to purchase 657 shares of common stock that are vested and exercisable (or will be vested and exercisable within 60 days of August 12, 2024). | |
(5) | Includes options to purchase 1,168 shares of common stock that are vested and exercisable (or will be vested and exercisable within 60 days of August 12, 2024). | |
(6) | Includes options to purchase 1,168 shares of common stock that are vested and exercisable (or will be vested and exercisable within 60 days of August 12, 2024). | |
(7) | Includes 181 shares of common stock held by Ms. Drexler, and options to purchase 1,231 shares of common stock that are vested and exercisable (or will be vested and exercisable within 60 days of August 12, 2024). |
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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
General
There have not been any transactionsor any series of similar transactions, since January 1, 2022, nor are we aware of any such pending transactions, to which we were a partyor will be a party, in which:
· | the amounts involved exceeded or will exceed the lesser of $120 thousand or onepercent of the average of our total assets for the last two fiscal years; and | |
· | any of our directors, executive officers, holders of more than 5% of our capitalstock or any member of their immediate family had or will have a direct or indirect material interest, other than equity and other compensation,termination, change in control and other arrangements with directors and executive officers, which are described where required underthe sections above entitled “Executive Compensation” and “Director Compensation.” |
Policies and Procedures RegardingRelated Party Transactions
Our Board has adopted a written relatedperson transaction policy setting forth the policies and procedures for the review and approval or ratification of related person transactions.This policy covers, with certain exceptions set forth in Item 404 of Regulation S-K under the Securities Act, any transaction, arrangementor relationship, or any series of similar transactions, arrangements or relationships in which we were or are to be a participant, wherethe amount involved exceeds $120 thousand and a related person had or will have a direct or indirect material interest, including, withoutlimitation, purchases of goods or services by or from the related person or entities in which the related person has a material interest,indebtedness, guarantees of indebtedness and employment by us of a related person. In reviewing and approving any such transactions, ourAudit and Risk Committee is tasked to consider all relevant facts and circumstances, including, but not limited to, whether the transactionis on terms comparable to those that could be obtained in an arm’s length transaction and the extent of the related person’sinterest in the transaction. The related person transactions disclosed in this Proxy Statement were each approved by the full Board orAudit and Risk Committee, as applicable.
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DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
Insofar as indemnification for liabilitiesarising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoingprovisions, the registrant has been informed that in the opinion of the SEC such indemnification is against public policy as expressedin the Securities Act and is therefore unenforceable.
Rosenberg Rich Baker Berman, P.A., independentregistered public accounting firm, has audited our financial statements at December 31, 2023 and 2022, and for the years then ended, asset forth in their report. We have included our financial statements in this Offering Circular in reliance on Rosenberg Rich Baker BermanP.A.’s report, given on their authority as experts in accounting and auditing.
Procopio, Cory,Hargreaves & Savitch LLP, San Diego, California, has acted as the Company’s legal counsel and will pass upon the validity ofthe Offered Shares offered hereunder. Carter Ledyard & Milburn LLP, New York, New York, has acted as special New York counsel to theCompany by providing an opinion on the validity of the Pre-Funded Warrants offered hereunder. The placement agent is represented by EllenoffGrossman & Schole LLP.
WHERE YOU CAN FIND MORE INFORMATION
We have filed an offeringstatement on Form 1-A with the SEC under the Securities Act with respect to the common stock offered by this Offering Circular. This OfferingCircular, which constitutes a part of the offering statement, does not contain all of the information set forth in the offering statementor the exhibits and schedules filed therewith. For further information with respect to us and our common stock, please see the offeringstatement and the exhibits and schedules filed with the offering statement. Statements contained in this Offering Circular regarding thecontents of any contract or any other document that is filed as an exhibit to the offering statement are not necessarily complete, andeach such statement is qualified in all respects by reference to the full text of such contract or other document filed as an exhibitto the offering statement. The offering statement, including its exhibits and schedules, may be accessed at the SEC’s website http://www.sec.gov.These filings will be available as soon as reasonably practicable after we electronically file such material with, or furnish it to, theSEC.
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TIVIC HEALTH SYSTEMS, INC.
Financial Statements
For the Years Ended December31, 2023 and 2022
Page | |
Report of Independent Registered Public Accounting Firm (PCAOB ID #89) | F-1 |
Balance Sheets as of December 31, 2023 and 2022 | F-2 |
Statements of Operations for the years ended December 31, 2023 and 2022 | F-3 |
Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2023 and 2022 | F-4 |
Statements of Cash Flows for the years ended December 31, 2023 and 2022 | F-5 |
Notes to Financial Statements | F-6 |
Unaudited Interim Condensed FinancialStatements
For the Three and Six Months EndedJune 30, 2024 and 2023
Condensed Balance Sheets as of June 30, 2024 (unaudited) and December 31, 2023 | F-29 |
Condensed Statements of Operations for the three and six months ended June 30, 2024 and 2023 (unaudited) | F-30 |
Condensed Statements of Stockholders’ Equity for the three and six months ended June 30, 2024 and 2023 (unaudited) | F-31 |
Condensed Statements of Cash Flow for the six months ended June 30, 2024 and 2023 (unaudited) | F-32 |
Notes to Condensed Financial Statements (unaudited) | F-33 |
F-1 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Stockholders of Tivic Health Systems,Inc.
Opinion on the Financial Statements
We have audited the accompanying balancesheets of Tivic Health Systems, Inc. (the Company) as of December 31, 2023 and 2022, and the related statements of operations, stockholders’equity, and cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively referredto as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial positionof the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the two-yearperiod ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statementshave been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, theCompany has incurred recurring losses and negative cash flows from operations and is dependent on additional financing to fund operations.These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans inregard to these matters are also described in Note 2. The financial statements do not include any adjustment that might result from theoutcome of this uncertainty.
Basis for Opinion
These financial statements are theresponsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statementsbased on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB)and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicablerules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordancewith the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whetherthe financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor werewe engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain anunderstanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of theCompany’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing proceduresto assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures thatrespond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financialstatements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well asevaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Rosenberg Rich Baker Berman,P.A.
We have served as the Company’sauditor since 2020
Somerset, New Jersey
March 25, 2024
F-2 |
Tivic Health Systems, Inc.
December 31, 2023 and 2022
(in thousands, except share and per share data)
December 31, 2023 | December 31, 2022 | |||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 3,395 | $ | 3,517 | ||||
Accounts receivable, net | 174 | 107 | ||||||
Inventory, net | 756 | 863 | ||||||
Deferred offering costs | – | 584 | ||||||
Prepaid expenses and other current assets | 327 | 235 | ||||||
Total current assets | 4,652 | 5,306 | ||||||
Property and equipment, net | 122 | 12 | ||||||
Right-of-use assets, operating lease | 349 | 523 | ||||||
Other assets | 34 | 34 | ||||||
Total assets | $ | 5,157 | $ | 5,875 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 713 | $ | 1,323 | ||||
Other accrued expenses | 495 | 392 | ||||||
Operating lease liability, current | 193 | 163 | ||||||
Total current liabilities | 1,401 | 1,878 | ||||||
Operating lease liability | 176 | 367 | ||||||
Total liabilities | 1,577 | 2,245 | ||||||
Commitments and contingencies (Note 6) | ||||||||
Stockholders’ equity | ||||||||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2023 and 2022, respectively | – | – | ||||||
Common stock, $0.0001par value, 200,000,000 shares authorized; 1,466,092 and 96,778 shares issued and outstanding at December 31, 2023 and 2022, respectively | – | – | ||||||
Additional paid in capital | 41,466 | 33,272 | ||||||
Accumulated deficit | (37,886 | ) | (29,642 | ) | ||||
Total stockholders’ equity | 3,580 | 3,630 | ||||||
Total liabilities and stockholders’ equity | $ | 5,157 | $ | 5,875 |
The accompanying notes are an integral part of these financial statements
F-3 |
Tivic Health Systems, Inc.
Years Ended December 31, 2023 and 2022
(in thousands, except share and per share data)
Years Ended December 31, | ||||||||
2023 | 2022 | |||||||
Revenue | $ | 1,176 | $ | 1,840 | ||||
Cost of sales | 889 | 1,541 | ||||||
Gross profit | 287 | 299 | ||||||
Operating expenses: | ||||||||
Research and development | 1,655 | 1,730 | ||||||
Sales and marketing | 2,125 | 2,792 | ||||||
General and administrative | 4,752 | 5,875 | ||||||
Total operating expenses | 8,532 | 10,397 | ||||||
Loss from operations | (8,245 | ) | (10,098 | ) | ||||
Other income: | ||||||||
Interest income | 1 | 2 | ||||||
Total other income | 1 | 2 | ||||||
Net loss before income taxes | $ | (8,244 | ) | $ | (10,096 | ) | ||
Net loss per share - basic and diluted | $ | (10.40 | ) | $ | (104.32 | ) | ||
Weighted-average number of shares - basic and diluted | 793,043 | 96,778 |
The accompanying notes are an integral part of these financial statements
F-4 |
Tivic Health Systems, Inc.
Statements of Stockholders’Equity
Years Ended December 31, 2023 and 2022
(in thousands except share and per share data)
Additional | Total | |||||||||||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Accumulated | Stockholders' | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||||||||
Balances at January 1, 2022 | – | $ | – | 97,153 | $ | – | $ | 32,818 | $ | (19,546 | ) | $ | 13,272 | |||||||||||||||
Exercise of stock options | – | – | 563 | – | 56 | – | 56 | |||||||||||||||||||||
Repurchase of restricted common stock | – | – | (938 | ) | – | – | – | – | ||||||||||||||||||||
Stock-based compensation expense | – | – | – | – | 398 | – | 398 | |||||||||||||||||||||
Net loss | – | – | – | – | – | (10,096 | ) | (10,096 | ) | |||||||||||||||||||
Balances at December 31, 2022 | – | $ | – | 96,778 | $ | – | $ | 33,272 | $ | (29,642 | ) | $ | 3,630 | |||||||||||||||
Issuance of common stock, net of issuance costs | – | – | 1,369,230 | – | 7,560 | – | 7,560 | |||||||||||||||||||||
Issuance of warrants | – | – | – | – | 363 | – | 363 | |||||||||||||||||||||
Issuance of common stock in lieu of fractional shares for stock split | – | – | 84 | – | – | – | – | |||||||||||||||||||||
Stock-based compensation expense | – | – | – | – | 271 | – | 271 | |||||||||||||||||||||
Net loss | – | – | – | – | – | (8,244 | ) | (8,244 | ) | |||||||||||||||||||
Balances at December 31, 2023 | – | $ | – | 1,466,092 | $ | – | $ | 41,466 | $ | (37,886 | ) | $ | 3,580 |
The accompanying notes are an integral part of these financial statements
F-5 |
Tivic Health Systems, Inc.
Years Ended December 31, 2023 and 2022
(in thousands)
Years Ended December 31, | ||||||||
2023 | 2022 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (8,244 | ) | $ | (10,096 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock based compensation | 271 | 398 | ||||||
Depreciation | 8 | 10 | ||||||
Amortization of right-of-use asset | 174 | 164 | ||||||
Reserve for inventory obsolescence | 32 | – | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | (67 | ) | 1 | |||||
Inventory | 75 | (434 | ) | |||||
Prepaid expenses and other current assets | (92 | ) | 558 | |||||
Accounts payable | (610 | ) | 534 | |||||
Accrued expenses | 103 | 109 | ||||||
Lease liabilities | (161 | ) | (178 | ) | ||||
Other assets | – | 15 | ||||||
Net cash used in operating activities | (8,511 | ) | (8,919 | ) | ||||
Cash flows from investing activities | ||||||||
Acquisition of property and equipment | (118 | ) | (11 | ) | ||||
Net cash used in investing activities | (118 | ) | (11 | ) | ||||
Cash flows from financing activities | ||||||||
Proceeds from exercise of stock options | – | 56 | ||||||
Proceeds from issuance of common stock, net of issuance costs | 8,507 | – | ||||||
Offering costs in advance of sale of common stock | – | (584 | ) | |||||
Net cash provided by (used in) financing activities | 8,507 | (528 | ) | |||||
Net decrease in cash and cash equivalents | (122 | ) | (9,458 | ) | ||||
Cash and cash equivalents | ||||||||
Beginning of period | 3,517 | 12,975 | ||||||
End of period | $ | 3,395 | $ | 3,517 | ||||
Supplemental disclosure on noncash financing activities | ||||||||
Issuance of common stock warrant | $ | 363 | $ | – | ||||
Deferred offering costs charged to additional paid-in-capital | $ | 584 | $ | – |
The accompanying notes are an integral part of these financial statements
F-6 |
Tivic Health Systems, Inc.
December 31, 2023 and 2022
(amounts are as indicated)
1. | Formation and Business of the Company |
Tivic Health Systems, Inc. (the “Company”),was incorporated in the state of California on September 22, 2016 for the purpose of developing and commercializing non-invasive bioelectronicmedicine. In June 2021, the Company was reincorporated as a Delaware corporation. The Company's first commercial product, ClearUP, isan FDA approved medical device for the treatment of sinus pain, pressure and nasal congestion. The Company is headquartered in Hayward,California..
2. | Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying financial statementshave been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”).The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and thesettlement of liabilities and commitments in the normal course of business. The accompanying financial statements do not include any adjustmentthat might be necessary if the Company is unable to continue as a going concern. Certain reclassifications have been made to the prioryear’s balance sheet, statement of operations and statement of cash flows to conform to the current year presentation.
Going Concern Uncertainty
The accompanying financial statementshave been prepared as if the Company will continue as a going concern. As noted above, the Company has experienced losses and negativecash flows from operations; incurred a net loss of $8.2 million during the year ended December 31, 2023; had cash and cash equivalentsof $3.4 million as of December 31, 2023; and had an accumulated deficit of $37.9 million as of December 31, 2023. The Company’sworking capital as of December 31, 2023 was approximately $3.3 million. The aforementioned factors raise substantial doubt about theCompany’s ability to continue as a going concern within one year from the issuance date of the financial statements. The accompanyingfinancial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction ofliabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverabilityand classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continueas a going concern within one year after the date the financial statements are issued.
Future capital requirements willdepend upon many factors, including, without limitation, progress with developing, manufacturing and marketing our technologies; the timeand costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights; our abilityto establish collaborative arrangements; completion of any acquisitions or other strategic transactions; marketing activities and competingtechnological and market developments, including regulatory changes and overall economic conditions in our target markets. Our abilityto generate revenue and achieve profitability requires us to successfully market and secure purchase orders for our products and servicesfrom existing as well as new customers. We also will be required to efficiently manufacture and deliver on those purchase orders. Theseactivities, including our planned research and development efforts, may require significant uses of working capital. There can be no assurancethat we will generate revenue and cash as expected in our current business plan.
F-7 |
The Company recognizes it will needto raise additional capital to continue research and development and to fund its planned operations, clinical trials and, if regulatoryapproval is obtained, commercialization of future products. We may seek additional funds through equity or debt offerings and/or borrowingsunder notes payable, lines of credit or other sources. We do not know whether additional financing will be available on commerciallyacceptable terms, or at all, when needed. If adequate funds are not available or are not available on commercially acceptable terms,our ability to fund our operations, support the growth of our business or otherwise respond to competitive pressures could be significantlydelayed or limited, which could materially adversely affect our business, financial conditions, or results of operations.
Reverse Stock Split
In August 2023, the Company’sBoard of Directors and stockholders approved an amendment to the Company’s amended and restated certificate of incorporation toeffect a 1-for-100 reverse stock split of the issued and outstanding shares of the Company’s common stock, which was effected onAugust 23, 2023. There was no change to the par value, or authorized shares, of either the common stock or preferred stock, as a resultof the reverse stock split. Fractional shares were not issued, and instead, the Company issued one whole share of the post reverse splitcommon stock to any stockholder who otherwise would have been entitled to receive a fractional share as a result of the reverse stocksplit. Consequently, 84 shares of common stock were issued in lieu of fractional shares. In addition, all options, warrants and otherconvertible securities of the Company outstanding immediately prior to the reverse stock split were adjusted by dividing the number ofshares of common stock into which such options, warrants and other convertible securities were exercisable or convertible by 100 andmultiplying the exercise or conversion price thereof by 100, all in accordance with the terms of the plans, agreements or arrangementsgoverning such options, warrants and other convertible securities and subject to rounding pursuant to such terms. All share and per shareamounts for the common stock, as well as the stock options, and warrants outstanding and exercise prices thereof, included in the financialstatements and these footnotes thereto have been retroactively restated to give effect to the reverse stock split.
Use of Estimates
The preparation of financial statementsin conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilitiesand disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during thereporting period. Actual results could differ materially from those estimates. The Company evaluates its estimates and assumptions onan ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstancesdictate.
Fair Value of Financial Instruments
The Company discloses and recognizesthe fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fairvalue. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in anorderly transaction between market participants at the reporting date. The hierarchy gives the highest priority to valuations based uponunadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuationsbased upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels ofthe fair value hierarchy as follows:
Level 1 Inputs that reflect unadjustedquoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date;
Level 2 Inputs other than quotedprices that are observable for the asset or liability either directly or indirectly, including inputs in markets that are not consideredto be active;
Level 3 Inputs are unobservable inwhich there is little or no market data available, which require the reporting entity to develop its own assumptions that are unobservable.
Assets and liabilities measured atfair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. TheCompany’s assessment of the significance of a particular input to the fair value measurement in its entirety requires managementto make judgments and consider factors specific to the asset or liability.
F-8 |
Cash and Cash Equivalents
The Company considers all highlyliquid investments with original maturities of three months or less at date of purchase to be cash equivalents. As of December 31, 2023and 2022, cash equivalents were $3.2 million and $3.1 million, respectively.
Accounts Receivable
Trade accounts receivable are recordedat the invoiced amount, net of allowances for doubtful accounts. The allowance for doubtful accounts is based on our assessment of thecollectability of accounts. Management regularly reviews the adequacy of the allowance for doubtful accounts by considering the age ofeach outstanding invoice, each customer’s expected ability to pay, and the collection history with each customer, when applicable,to determine whether a specific allowance is appropriate. Accounts receivable deemed uncollectible are charged against the allowance fordoubtful accounts when identified. As of each December 31, 2023 and 2022, the allowance for doubtful accounts was zero.
Inventory
Inventories are stated at the lowerof cost or net realizable value, with cost determined on a first-in, first-out (“FIFO”) basis. Inventories are reviewed periodicallyto identify slow-moving inventory based on anticipated sales activity. As of December 31, 2023 and 2022, the reserve for obsolescencewas $32,000 and zero, respectively.
Deferred Offering Costs
Deferred offering costs are comprisedof costs incurred in connection with financing arrangements that have not closed as of the end of the period. As of December 31, 2022,deferred offering costs of $584 thousand, primarily consisted of legal fees, technical accounting support, printer costs and other regulatoryfiling fees related to the sale of 200,000 shares of our common stock, which closed subsequent to year-end. Deferred offering costs arereclassified to additional paid in capital upon closing of the financing transaction. There were no deferred offering costs as of December31, 2023.
Property and Equipment
Property and equipment are recordedat cost net of accumulated depreciation. Depreciation is computed on a straight-line method over the estimated useful lives of the assets,three to four years. Upon retirement or sale of assets, the cost and related accumulated depreciation are removed from the balance sheetand the resulting gain or loss is reflected in operations. Repairs and maintenance costs that do not improve or extend the lives of therespective assets are charged to operations as incurred.
Impairment of Long-Lived Assets
The Company evaluates its long-livedassets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amountof these asset may not be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset tothe future undiscounted cash flows the asset is expected to generate over its remaining life. When indications of impairment are presentand the estimated undiscounted future cash flows from the use of these assets is less than the assets’ carrying value, the relatedassets will be written down to fair value. There were no impairments of the Company’s long-lived assets for the periods presented.
F-9 |
Commitments and Contingencies
Liabilities for loss contingenciesarising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liabilityhas been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensedas incurred.
Revenue Recognition
The Company recognizes revenue fromproduct sales in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)Topic 606, Revenue from Contracts with Customers (“Topic 606”). The adoption of this guidance did not have a material impacton the Company’s financial statements. The standard applies to all contracts with customers, except contracts that are within scopeof other standards, such as leases, insurance, collaboration arrangements and financial instruments.
Under Topic 606, an entity recognizesrevenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entityexpects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determinesare in within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii)identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to theperformance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Companyonly applies the five-step model to contracts when it is probable the entity will collect the consideration it is entitled to in exchangefor the goods or services it transfers to the customer. At contract inceptions, once the contract is determined to be within the scopeof Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligationsand assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction pricethat is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
The Company sells its products throughdirect sales and reseller. Revenue is recognized when control of the promised goods is transferred to the customers or the resellers,upon shipment of the product, in an amount that reflects the consideration the Company expects to be entitled to in exchange for thosegoods. Revenue associated with products holding rights of return are recognized when the Company concludes there is not a risk of significantrevenue reversal in the future periods for the expected consideration in the transaction.
The Company may receive paymentsat the onset of the contract and before goods have been delivered. In such instances, the Company records a deferred revenue liability.The Company recognizes these contract liabilities as sales after the revenue criteria are met. As of December 31, 2023 and 2022, the contractliability related to the Company’s deferred revenues approximated $8 thousand and $2 thousand, respectively, and are included in“Other Accrued Expenses” on the accompanying balance sheets.
The Company relies on a third partyto have procedures in place to detect and prevent credit card fraud as the Company has exposure to losses from fraudulent charges. TheCompany records the losses related to chargebacks as incurred.
The Company has also elected to excludefrom the measurement of the transaction price sales taxes remitted to governmental authorities.
F-10 |
The table below presents revenue bychannel for the years ended December 31, 2023 and 2022 (in thousands):
Year Ended December 31, | ||||||||
Product Revenue by Sales Channel | 2023 | 2022 | ||||||
Product Revenue | ||||||||
Direct-to-consumer | $ | 1,079 | $ | 1,635 | ||||
Reseller | 261 | 416 | ||||||
Returns | (164 | ) | (211 | ) | ||||
Revenue | $ | 1,176 | $ | 1,840 |
Sales Tax
Sales tax collected from customersand remitted to governmental authorities is accounted for on a net basis and therefore, is excluded from net sales.
Shipping and Handling
Shipping and handling fees paid bycustomers are recorded within net sales, with the related expenses recorded in cost of sales. Shipping and handling fees paid by customersin each of the years ended December 31, 2023 and 2022 were $3 thousand. Shipping costs for delivery of product to customers in the yearsended December 31, 2023 and 2022 were $59 thousand and $96 thousand, respectively.
Product Warranty
The Company generally offers a one-yearlimited warranty on its products. The Company estimates the costs associated with the warranty obligation using historical data of warrantyclaims and costs incurred to satisfy those claims. Estimated warranty costs are expensed to cost of sales.
Returns
The Company estimates a reservefor future product returns based several factors, including historical returns as a percentage of revenue, an understanding of the reasonsfor past returns and any other known factors that indicate a return is imminent. Reserves for sales returns are estimated and recordedin the same period as the underlying revenue recognition as a deduction to arrive at net product sales and as a liability classified asOther accrued expenses on the balance sheet. As of December 31, 2023 and 2022, the reserve for sales returns was $52 thousand and $19thousand, respectively.
Sales and Marketing Expenses
Sales and marketing expenses areexpensed as incurred and consist primarily of merchandising, customer service and targeted online marketing costs, such as display advertising,keyword search campaigns, search engine optimization and social media and offline marketing costs such as television, radio and printadvertising. Sales and marketing expenses also include payroll costs and stock-based compensation expense for employees involved in marketingactivities. Sales and marketing expenses are primarily related to growing and retaining the customer base. Advertising and other promotionalcosts to market the Company’s products and services amounted to $822 thousand and $1.3 million for the years ended December 31,2023 and 2022, respectively.
F-11 |
Research and Development Expenses
Research and development expensesinclude costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes,employee benefits, materials, supplies, depreciation on and maintenance of research equipment, the cost of services provided by outsidecontractors, and the allocable portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation,and general support services. All costs associated with research and development are expensed as incurred.
Stock-Based Compensation
The Company accounts for stock-basedcompensation arrangements with employees and non-employee consultants using a fair value method which requires the recognition of compensationexpense for costs related to all stock-based payments, including stock options. The fair value method requires the Company to estimatethe fair value of stock-based payment awards to employees and non-employees on the date of grant using an option pricing model.
Stock-based compensation costs arebased on the fair value of the underlying option calculated using the Black-Scholes option-pricing model and recognized as expense ona straight-line basis over the requisite service period, which is the vesting period. The Company measures equity-based compensation awardsgranted to non-employees at fair value as the awards vest and recognizes the resulting value as compensation expense at each financialreporting period.
Determining the appropriate fairvalue model and related assumptions requires judgment, including estimating stock price volatility, expected dividend yield, expectedterm, risk-free rate of return, and the estimated fair value of the underlying common stock. Due to the lack of company-specific historicaland implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similarcompanies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected termassumption. The group of representative companies have characteristics similar to the Company, including stage of product developmentand focus on the life science industry. The Company uses the simplified method, which is the average of the final vesting tranche dateand the contractual term, to calculate the expected term for options granted to employees as it does not have sufficient historical exercisedata to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrumentwhose term is consistent with the expected term of the stock options. The Company uses an assumed dividend yield of zero as the Companyhas never paid dividends and has no current plans to pay any dividends on its common stock. The Company accounts for forfeitures as theyoccur.
Segment Reporting
Operating segments are identifiedas components of an enterprise for which separate discrete financial information is available for evaluation by the Company’s ChiefExecutive Officer to make decisions with respect to resource allocation and assessment of performance. To date, the Company has viewedits operations and manages its business as one operating segment.
Net Loss per Common Share
The Company computes net loss pershare of common stock in conformity with the two-class method required for participating securities. Diluted net loss per share is computedsimilar to basic net loss per share except that the denominator is increased to include the number of additional shares for the potentialdilutive effects of warrants, convertible preferred stock and stock options outstanding during the period calculated in accordance withthe treasury stock method, or the two-class method, whichever is more dilutive. For all periods presented, basic and diluted net lossper share is the same, as inclusion of any additional share equivalents would be anti-dilutive.
F-12 |
Income Taxes
Income taxes are accounted for underthe asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differencesbetween the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating lossand tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable incomein the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilitiesof a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are establishedwhen necessary to reduce deferred taxes to the amounts expected to be realized.
The Company recognizes benefits ofuncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technicalmerit, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. The Company’spolicy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit.To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits.
Concentration of Credit Riskand Other Risks and Uncertainties
Financial instruments that potentiallysubject the Company to significant concentrations of credit risk consist of cash and cash equivalents and accounts receivable. Cash andcash equivalents include a checking account and a money market account held at one national financial institution in the United States.At times, such deposits may be in excess of insured limits. Despite recent concerns regarding the stability of certain banking institutionsin the United States, management believes that the financial institution at which the Company holds its deposits is financially sound,and accordingly, minimal credit risk exists with respect to the financial institution. The Company has not experienced any losses on itsdeposits of cash and cash equivalents. As of each December 31, 2023 and 2022, the Company had cash and cash equivalents balances exceedingFDIC insured limits by $3.0 million.
The Company extends credit to customersin the normal course of business and performs credit evaluations of its customers. Concentrations of credit risk with respect to accountsreceivable exist to the full extent of amounts presented in the financial statements.
During 2023, the majority, or 79%,of the Company’s sales have been to individual consumers. As of December 31, 2023, the Company had one customer whose accountsreceivable balance totaled more than 10% or more of the Company’s total accounts receivable (81%) compared with two customers atDecember 31, 2022 (43% and 18%).
For the year ended December 31,2023, the Company had one customer who individually accounted for 10% or more of the Company’s total revenue (20%) compared withone customer for the year ended December 31, 2022 (20%).
The world has been affected by theCOVID-19 pandemic, the ongoing conflict between Russia and Ukraine, economic uncertainty in human capital management and certain othermacroeconomic factors including climate change, inflation, and rising interest rates. Additionally, events involving limited liquidity,defaults, non-performance or other adverse developments that affect financial institutions or the financial services industry generally,or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wideliquidity problems. For example, in March 2023, Silicon Valley Bank and Signature Bank were closed and taken over by the FDIC, which createdsignificant market disruption and uncertainty for those who bank with those institutions, and which raised significant concern regardingthe stability of the banking system in the United States, and in particular with respect to regional banks. These factors, amongst otherthings, could result in further economic uncertainty and volatility in the capital markets in the near term, and could negatively affectour operations. We will continue to monitor material impacts on our business strategies and operating results.
F-13 |
Leases
At the inception of an arrangement,the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contractas a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economicbenefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets andoperating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options thatthe Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or lesson its balance sheets. The Company’s only existing lease is for office space.
The ROU asset represents the rightto use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. Thepresent value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable;otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term.
Lease expense for operating leasesis recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operatingexpense in the statement of operations.
The Company’s facility leasecontracts often include lease and non-lease components. The Company has elected the practical expedient offered by the standard to notseparate lease from non-lease components and accounts for them as a single lease component.
The Company has elected, for allclasses of underlying assets, not to recognize ROU assets and lease liabilities for leases with a term of twelve months or less. Leasecost for short-term leases is recognized on a straight-line basis over the lease term.
Recently issued accountingpronouncement - Not yet adopted:
In November 2023, the Financial AccountingStandards Board (“FASB”) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280) - Improvementsto Reportable Segment Disclosures. The guidance, which becomes effective for fiscal years beginning after December 15, 2023 and interimperiods within fiscal years beginning after December 15, 2024, requires public entities that are required to report segment informationin accordance with Topic 280, Segment Reporting, to improve reportable segment disclosures about significant segment expenses. We do notbelieve that ASU 2023-07 will have a material impact on our reporting as we operate in one reportable segment.
In December 2023, the FASB issued AccountingStandards Update (ASU) 2023-09, Income Taxes (Topic 740)- Improvements to Income Tax Disclosures. The guidance applies to allentities that are subject to Topic 740, Income taxes and becomes effective for public business entities for annual periods beginningafter December 15, 2024. The guidance requires enhanced disclosures related to income taxes including: additional information in therate reconciliation; further breakdown of income taxes paid; and other disclosures that may help investors to better understand the entitiestax landscape. We do not believe that ASU 2023-09 will have a material impact on our financial reporting.
F-14 |
3. | Financial Instruments and Fair Value Measurements |
The Company’s financial instrumentsconsist of money market funds. The following tables show the Company’s cash equivalent’s carrying value and fair value atDecember 31, 2023 and 2022 (in thousands):
As of December 31, 2023 | ||||||||||||||||||||
Carrying Amount | Fair Value | Quoted Priced in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | ||||||||||||||||
Assets | ||||||||||||||||||||
Money market funds | $ | 3,243 | $ | 3,243 | $ | 3,243 | $ | – | $ | – | ||||||||||
Total assets | $ | 3,243 | $ | 3,243 | $ | 3,243 | $ | – | $ | – |
As of December 31, 2022 | ||||||||||||||||||||
Carrying Amount | Fair Value | Quoted Priced in active markets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | ||||||||||||||||
Assets | ||||||||||||||||||||
Money market funds | $ | 3,074 | $ | 3,074 | $ | 3,074 | $ | – | $ | – | ||||||||||
Total assets | $ | 3,074 | $ | 3,074 | $ | 3,074 | $ | – | $ | – |
Cash equivalents – Cash equivalentsof $3.2 million and $3.1 million as of December 31, 2023 and 2022, respectively, consisted of money market funds. Money market funds areclassified as Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets.
Certain assets and liabilities arecarried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfera liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction betweenmarket participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputsand minimize the use of unobservable inputs.
There have been no changes to thevaluation methods utilized by the Company during the years ended December 31, 2023 and 2022. The Company evaluates transfers between levelsat the end of each reporting period. There were no transfers of financial instruments between levels during the years ended December 31,2023 and 2022.
F-15 |
4. | Inventory, net (in thousands) |
December 31, 2023 | December 31, 2022 | |||||||
Raw materials | $ | 752 | $ | 724 | ||||
Work in process | – | 23 | ||||||
Finished goods | 36 | 116 | ||||||
Inventory at cost | 788 | 863 | ||||||
Less reserve for obsolescence | (32 | ) | – | |||||
Inventory | $ | 756 | $ | 863 |
5. | Property and equipment, net (in thousands) |
December 31, 2023 | December 31, 2022 | |||||||
Computers and equipment | $ | 11 | $ | 11 | ||||
Manufacturing tools and dies | 148 | 30 | ||||||
Total property and equipment | 159 | 41 | ||||||
Less accumulated depreciation | (37 | ) | (29 | ) | ||||
Property and equipment, net | $ | 122 | $ | 12 |
Depreciation expense was $8 thousandand $10 thousand for the years ended December 31, 2023 and 2022, respectively.
6. | Commitments and Contingencies |
Lease
The Company executed a noncancelableoperating lease for approximately 9,091 square feet of office space in Hayward, California in November 2021 as its headquarters. The leaseexpires in October 2025 and there is no option to renew for an additional term. The Company is obligated to pay, on a pro-rata basis,real estate taxes and operating costs related to the premises. Upon lease execution, the Company evaluated the lease and determined itshould be capitalized as an operating lease. As there was no interest rate implicit in the lease, the Company estimated the incrementalborrowing rate at 6% based on the rate available under its revolving credit line, as well as an assessment of the Company’s riskbased on its financial position at the time and its potential to obtain a collateralized loan for a period similar to the lease term.
F-16 |
The lease costs for the years ended December 31, 2023 and2022 are as follows (in thousands):
December 31, 2023 | December 31, 2022 | |||||||
Operating lease cost | $ | 201 | $ | 201 | ||||
Short term lease cost | 21 | 22 | ||||||
Total lease cost | $ | 222 | $ | 223 |
Amounts reported in the balance sheetfor leases where the Company is the lessee as of December 31, 2023 are as follows (in thousands):
Right-of-use assets, operating lease | $ | 349 | ||
Operating lease liabilities, current | $ | 193 | ||
Operating lease liabilities, non-current | 176 | |||
Total operating lease liabilities | $ | 369 | ||
Remaining lease term (in years) | 1.75 | |||
Discount rate | 6.0% |
Cash paid for amounts included in themeasurement of operating lease liabilities were $206 thousand and $189,000 for the years ended December 31, 2023 and 2022, respectively,which is included in operating activities in the statements of cash flow.
Future minimum lease payments remaining as of December31, 2023 under the operating lease by fiscal year are as follows (in thousands):
Fiscal Year | ||||
2024 | 210 | |||
2025 | 178 | |||
Total minimum lease payments | 388 | |||
Less imputed interest | (19 | ) | ||
Present value of lease payments | $ | 369 |
ALOM Fulfillment Service Agreement
On November 25, 2022, the Companyentered into a Fulfillment Services Agreement (the “ALOM Agreement”), with ALOM Technologies Corporation (“ALOM”).Pursuant to the ALOM Agreement, commencing on November 28, 2022, ALOM began providing, on a non-exclusive basis, certain assembly, procurement,storage, returns, and fulfillment services to our end customers and retailers within the United States. During the term of the ALOM Agreement,ALOM shall provide the services in accordance with purchase orders issued by us from time to time. The consideration payable by us toALOM for services rendered under the ALOM Agreement will be calculated and invoiced based on fixed hourly rates and fixed unit pricing,as applicable, subject to certain exceptions; provided that, commencing April 1, 2023, we became subject to $25 thousand minimum monthlypurchase requirement. The ALOM Agreement has a three-year initial term, with automatic annual renewals, and may be terminated for convenienceby either party upon sixty days written notice to the other party. Subsequent to the year ended December 31, 2023, the ALOM Agreementwas amended to waive hourly account management charges and minimum monthly purchase requirements for the period from January 2024 throughJune 2024, and to extend the initial term of the agreement to December 31, 2024.
F-17 |
Contingencies
From time to time, the Company mayhave certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability forsuch matters when future expenditures are probable and such expenditures can be reasonably estimated. The Company recorded no liabilitiesfor contingent matters as of December 31, 2023.
7. | Other Accrued Expenses (in thousands) |
December 31, 2023 | December 31, 2022 | |||||||
Accrued payroll and related | $ | 218 | $ | 145 | ||||
Accrued secondary offering costs | – | 150 | ||||||
Delaware franchise tax | 160 | – | ||||||
Other | 117 | 97 | ||||||
Total other accrued expenses | $ | 495 | $ | 392 |
8. | Preferred Stock |
There were no series of preferred stockdesignated and no shares issued or outstanding at December 31, 2023 and 2022.
The Company’s board of directorsis authorized, without action by its stockholders, to designate and issue up to 10,000,000 shares of preferred stock in one or more series,and to fix the voting rights, designations, powers, preferences, the relative, participating, optional or other special rights, if any,and any qualifications, limitations and restrictions thereof, applicable to the shares of any series of preferred stock that they maydesignate in the future.
9. | Common Stock |
At December 31, 2023 and 2022, therewere 1,466,092 and 96,778 shares of Company common stock issued and outstanding, respectively.
On April 1, 2022, the Company exercisedits right and repurchased 938 shares of unvested restricted common stock from an employee upon the termination of such employee’semployment by the Company.
On February 13, 2023, the Company sold200,000 shares of its common stock in an underwritten public offering at a price of $25 per share, less underwriting discounts and commissions,resulting in gross proceeds to the Company of $5.0 million. The net proceeds to the Company, after deducting the underwriting discountand commissions and expenses paid by the Company, was approximately $3.6 million. In addition, pursuant to the underwriting agreemententered into in connection with the offering, the Company granted the underwriter a 45-day option to purchase up to an additional 30,000shares of common stock, solely to cover over-allotments. This option expired in March 2023, and the underwriter did not exercise itsoption to purchase any additional shares prior to such expiration. Additionally, as partial consideration for services rendered in connectionwith the offering, the Company issued warrants to purchase an aggregate of 10,000 shares of Company common stock to designees of ThinkEquity.The designees paid an aggregate of $100 for the warrants. The warrants have an initial exercise price of $31.25 per share, have a termof four years from the commencement of sales in the offering, and are exercisable commencing six months from closing.
F-18 |
On July 11, 2023, the Company sold325,000 shares of its common stock to certain investors at a price of $5.50 per share, resulting in gross proceeds to the Company ofapproximately $1.8 million. Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company,was approximately $1.5 million. As compensation for services rendered by the placement agent, the Company paid the placement agent acash fee of 8.0% of the aggregate gross proceeds of the offering (amounting to $143 thousand) at closing, as well as $90 thousand forthe reimbursement of certain expenses. Additionally, as partial consideration for services rendered in connection with the offering,the Company issued the placement agent unregistered warrants to purchase an aggregate of 13,000 shares of Company common stock, representing4.0% of the aggregate shares sold in the offering. The warrants have an initial exercise price of $6.60 per share (equal to 120% of theoffering price per share), have a term of five years from the commencement of sales in the offering, and are exercisable commencing sixmonths from closing.
On July 19, 2023, the Company sold512,500 shares of its common stock to certain investors at a price of $4.00 per share, resulting in gross proceeds to the Company ofapproximately $2.1 million. Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company,was approximately $1.7 million. As compensation for services rendered by the placement agent, the Company paid the placement agent acash fee of 8.0% of the aggregate gross proceeds of the offering (amounting to $164 thousand) at closing, as well as $60 thousand forthe reimbursement of certain expenses. Additionally, as partial consideration for services rendered in connection with the offering,the Company issued the placement agent unregistered warrants to purchase an aggregate of 20,500 shares of common stock, representing4.0% of the aggregate shares sold in the offering. The warrants have an initial exercise price of $4.80 per share (equal to 120% of theoffering price per share), have a term of five years from the commencement of sales in the offering, and are exercisable commencing sixmonths from closing.
On August 9, 2023, the Company sold331,730 shares of its common stock to certain investors at a price of $4.10 per share, resulting in gross proceeds to the Company ofapproximately $1.4 million. Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company,was approximately $1.1 million. As compensation for services rendered by the placement agent, the Company paid the placement agent acash fee of 8.0% of the aggregate gross proceeds of the offering (amounting to approximately $109 thousand) at closing, as well as $60thousand for the reimbursement of certain expenses. Additionally, as partial consideration for services rendered in connection with theoffering, the Company issued the placement agent unregistered warrants to purchase an aggregate of 13,270 shares of Company common stock,representing 4.0% of the aggregate shares sold in the offering. The warrants have an initial exercise price of $4.92 per share (equalto 120% of the offering price per share), have a term of five years from the commencement of sales in the offering, and are exercisablecommencing six months from closing.
Effective August 23, 2023, the Company’sboard of directors approved a reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.0001per share, at a ratio of 1-for-100. As a result of the reverse stock split, the total number of shares of common stock held by each stockholderof the Company were converted automatically into the number of shares of common stock equal to the number of issued and outstanding sharesof common stock held by each such stockholder immediately prior to the reverse stock split divided by 100. The Company issued one wholeshare of the post reverse stock split common stock to any stockholder who otherwise would have been entitled to receive a fractionalshare as a result of the reverse stock split. As a result, no fractional shares were issued in connection with the reverse stock splitand no cash or other consideration was paid in connection with any fractional shares that would otherwise have resulted from the reversestock split. Also, all options, warrants and other convertible securities of the Company outstanding immediately prior to the reversestock split were adjusted by dividing the number of shares of common stock into which such options, warrants and other convertible securitieswere exercisable or convertible by 100 and multiplying the exercise or conversion price thereof by 100, all in accordance with the termsof the plans, agreements or arrangements governing such options, warrants and other convertible securities and subject to rounding pursuantto such terms. There was no change to the par value, or authorized shares, of either the common stock or preferred stock, as a resultof the reverse stock split. All share and per share amounts for the common stock, as well as the warrants outstanding and exercise pricesthereof, have been retroactively restated to give effect to the reverse stock split.
F-19 |
Common stockholders are entitledto dividends if and when declared by the Board of Directors subject to the rights of the preferred stockholders. As of December 31, 2023,no dividends on common stock had been declared by the Company. At December 31, 2023 and 2022, the Company had reserved shares of commonstock for issuance as follows:
December 31, | December 31, | |||||||
2023 | 2022 | |||||||
Warrants to purchase common stock | 59,497 | 2,727 | ||||||
Options issued and outstanding | 14,661 | 12,698 | ||||||
Shares available for future stock option grants | 7,190 | 4,564 | ||||||
Total | 81,348 | 19,989 |
10. | Common Stock Warrants |
Historically, the Company has enteredinto warrant agreements in connection with certain consulting agreements and equity offerings. In August 2023, the Company implementeda 1-for-100 reverse stock split wherein, per the terms of the agreements, the number of shares of common stock issuable upon exerciseof each of the warrants outstanding at that time was reduced by dividing the quantity outstanding by 100 and the exercise price of eachsuch warrant was multiplied by 100. No other terms of the warrants were changed as a result of the reverse stock split.
In July 2021, the Company enteredinto a consulting agreement, pursuant to which 500 warrants to purchase common stock were granted and an additional 500 warrants to purchasecommon stock were granted in November 2021. The warrants are exercisable upon issuance, have an exercise price of $104 per share and havea term of five years. The consulting agreement was effective as of February 2021, had an initial monthly fee of $5 thousand and a termof two years. The agreement was amended in May of 2022 to increase the monthly payment to $7.5 thousand. Currently, the agreement is automaticallyrenewing on a month-to-month basis until terminated by either party. The warrant issuances are indexed to, and settled in, the Company’sown common stock and were classified within stockholders’ equity.
In November 2021, the Company issuedwarrants to purchase 1,727 shares of common stock to designees of ThinkEquity LLC (“ThinkEquity”), the underwriter of theIPO. The warrants may be exercised at any time on or after May 9, 2022, have an exercise price of $625 per share and have a term of fiveyears. The warrant issuances are indexed to and settled in the Company’s own common stock and were classified within stockholders’equity.
In February 2023, the Company issuedwarrants to purchase 10,000 shares of common stock to designees of ThinkEquity, the underwriter of the underwritten public offering of200,000 shares of Company common stock that closed in February 2023. The designees paid an aggregate of $0.1 thousand for the warrants.The warrants may be exercised at any time on or after August 7, 2023, have an exercise price of $31.25 per share, and have a term of fouryears commencing 180 days following the commencement of sales in the offering. The warrant issuances were indexed to and settled in theCompany’s own stock and were classified within stockholders’ equity.
In July and August 2023, the Companyissued a total of 47,670 warrants to purchase shares of common stock to Maxim Group, LLC (“Maxim”), the placement agent foreach of the three public offerings of the Company’s common stock completed during the period. The warrants are exercisable at anytime beginning six months after the close of the applicable equity offering and expire five years from the from the commencement of salesunder the applicable offering. Of the warrants issued in the offerings, 13,000 are exercisable beginning on January 11, 2024 at a priceof $6.60 per share; 20,500 are exercisable beginning on January 19, 2024 at a price of $4.80 per share; and 13,270 are exercisable beginningon February 9, 2024 at a price of $4.92 per share.
F-20 |
The Company estimated the value ofthe warrants in 2023 using the Black-Scholes options valuation model. The fair value of the warrants issued in February 2023 was $195thousand and was recognized as issuance costs of the common stock issued in the underwritten public offering and was classified withinstockholders’ equity. The fair value of the warrants issued in July and August 2023 totaled $168 thousand and was recognized asissuance costs of the common stock issued in the three offerings during the period and was classified within stockholders’ equity.
The fair value of the warrants issuedin 2023 was estimated on the date of grant using the following assumptions:
2023 | ||||||||
Minimum | Maximum | |||||||
Expected life (in years) | 4.0 | 5.0 | ||||||
Expected volatility | 116.11% | 123.90% | ||||||
Risk-free interest rate | 3.98% | 4.24% | ||||||
Dividend yield | 0% | 0% |
A summary of the Company’s outstanding warrants as ofDecember 31, 2023 is as follows:
Class of Shares | Number of Warrants | Exercise Price | Expiration Date | ||||||||
Common Stock | 500 | $ | 104.00 | July 1, 2026 | |||||||
Common Stock | 500 | $ | 104.00 | November 15, 2026 | |||||||
Common Stock | 1,727 | $ | 625.00 | November 10, 2026 | |||||||
Common Stock | 10,000 | $ | 31.25 | August 9, 2027 | |||||||
Common Stock | 13,000 | $ | 6.60 | July 10, 2028 | |||||||
Common Stock | 20,500 | $ | 4.80 | July 14, 2028 | |||||||
Common Stock | 13,270 | $ | 4.92 | August 4, 2028 |
11. | Equity Incentive Plans |
In 2017, the Company adopted the2017 Equity Incentive Plan (the “2017 Plan”).
On November 10, 2021, the 2017 Planterminated and was replaced by the 2021 Plan (defined below), and future issuances of incentive instruments will be governed by the 2021Plan. To the extent that outstanding awards under the 2017 Plan are forfeited or lapse unexercised, the shares of common stock subjectto such awards will no longer be available for future issuance.
F-21 |
2021 Equity Incentive Plan
In 2021, the Company adopted the 2021Equity Incentive Plan (the “2021 Plan”). Options granted under the 2021 Plan may be Incentive Stock Options or Non-statutoryStock Options, as determined by the Compensation Committee of the Company’s board of directors, who is responsible for administeringthe 2021 Plan. Stock Purchase Rights may also be granted under the 2021 Plan. The term shall be no more than ten years from the dateof grant thereof. In the case of an Incentive Stock Option granted to an optionee who, at the time the option is granted, owns stockrepresenting more than 10% of the voting power of all classes of stock of the Company or any Parent or Subsidiary, the term of the optionshall be five years from the date of grant or such shorter term as may be provided in the option Agreement. To the extent outstandingawards under the 2021 Plan are forfeited or lapse unexercised, the shares of common stock subject to such awards will be available forfuture issuance under the 2021 Plan. The 2021 Plan provides that additional shares will automatically be added to the shares authorizedfor issuance under the 2021 Plan on January 1 of each year. The number of shares added each year will be equal to the lesser of: (i)5.0% of the outstanding shares of the Company’s common stock on December 31st of the preceding calendar year or (ii) such numberof shares determined by the board of directors, in its discretion. On January 1, 2023, 4,839 shares were automatically added to the numberof shares authorized for issuance under 2021 Plan (an increase equal to 5% of the number of the outstanding shares of Company commonstock as of December 31, 2022. Subsequent to the year ended December 31, 2023, on January 1, 2024, 73,304 shares were automatically addedto the number of shares authorized for issuance under 2021 Plan (an increase equal to 5% of the number of the outstanding shares of Companycommon stock as of December 31, 2023).
In the case of an Incentive StockOption, (i) granted to an employee who, at the time of grant of such option, owns stock representing more than 10% of the voting powerof all classes of stock of the Company or any Parent or Subsidiary, the exercise price shall be no less than 110% of the Fair Market Valueper Share on the date of grant; (ii) granted to any other employee, the per share exercise price shall be no less than 100% of the FairMarket Value per Share on the date of grant. In the case of a Non-statutory Stock Option, the per share exercise price shall be no lessthan 100% of the Fair Market Value per Share on the date of grant. Notwithstanding the foregoing, options may be granted with a per shareexercise price other than as required above pursuant to a merger or other corporate transaction.
The options may include provisionspermitting exercise of the option prior to full vesting. Any unvested shares upon termination shall be subject to repurchase by the Companyat the original exercise price of the option. Stock options granted under the Company’s equity incentive plans generally vest overfour years from the date of grant.
As of December 31, 2023, there were7,190 shares of common stock available for issuance under the 2021 Plan.
F-22 |
The following table summarizesthe option activity for the years ended December 31, 2023 and 2022:
Options Outstanding | ||||||||||||||||||||||||
Weighted- | ||||||||||||||||||||||||
Average | ||||||||||||||||||||||||
Shares | Weighted | Weighted- | Remaining | Aggregate | ||||||||||||||||||||
Available | Average | Average | Contractual | Intrinsic | ||||||||||||||||||||
For | Number of | Exercise | Grant Date | Life | Value | |||||||||||||||||||
Grant | Options | Price | Fair Value | (in years) | (in thousands) | |||||||||||||||||||
Balances, January 1, 2022 | 7,073 | 6,082 | $ | 223.00 | $ | 1.06 | 8.56 | $ | 1,163 | |||||||||||||||
Shares reserved for issuance | 4,858 | – | ||||||||||||||||||||||
Reserved shares cancelled | – | – | ||||||||||||||||||||||
Options granted | (7,367 | ) | 7,367 | $ | 171.00 | $ | 1.01 | |||||||||||||||||
Options forfeited / cancelled | – | (188 | ) | $ | 100.00 | $ | 0.44 | |||||||||||||||||
Options expired | – | – | $ | – | $ | – | ||||||||||||||||||
Options exercised | – | (563 | ) | $ | 100.00 | $ | 0.44 | |||||||||||||||||
Balances, December 31, 2022 | 4,564 | 12,698 | $ | 200.00 | $ | 1.06 | 7.77 | $ | 62 | |||||||||||||||
Shares reserved for issuance | 4,839 | – | ||||||||||||||||||||||
Reserved shares cancelled | – | – | ||||||||||||||||||||||
Options granted | (5,750 | ) | 5,750 | $ | 12.68 | $ | 0.12 | |||||||||||||||||
Options forfeited / cancelled | 3,537 | (3,787 | ) | $ | 131.45 | $ | 0.90 | |||||||||||||||||
Options expired | – | – | $ | – | $ | – | ||||||||||||||||||
Options exercised | – | – | $ | – | $ | – | ||||||||||||||||||
Balances, December 31, 2023 | 7,190 | 14,661 | $ | 144.41 | $ | 0.74 | 7.42 | $ | – | |||||||||||||||
At December 31, 2023 | ||||||||||||||||||||||||
Vested and exercisable | 6,110 | $ | 199.12 | 0.97 | 6.27 | $ | – |
The weighted-average grant date fairvalue per share of stock options granted in 2023 and 2022 was $0.12 and $1.01, respectively. The aggregate intrinsic value of optionsvested and exercisable as of December 31, 2023 is calculated based on the difference between the exercise price and the current fairvalue of our common stock. As of December 31, 2023 there were no options outstanding or vested with an exercise price in excess of themarket price of our stock.
The following table sets forth the status of the Company’snon-vested restricted common stock awards issued to employees:
Number of Shares | Weighted- Average Grant-Date Fair Value Per Share | |||||||
Non-vested as of January 1, 2022 | 1,009 | $ | 0.36 | |||||
Vested | (71 | ) | $ | 0.36 | ||||
Cancelled | (938 | ) | $ | 0.36 | ||||
Non-vested as of December 31, 2022 | – | $ | – |
The fair value of restricted stockawards vested during the year ended December 31, 2022 was $11 thousand. There were no restricted stock awards outstanding during theyear ended December 31, 2023.
F-23 |
Stock-Based Compensation
Options generally vest over four yearswhereby 25% vest upon the first anniversary of the issuance date and 1/36th per month thereafter. Stock-based compensation expense recognizedduring the years ended December 31, 2023 and 2022 was $271 thousand and $398 thousand, respectively. As of December 31, 2023, there weretotal unrecognized compensation costs of $440 thousand related to share-based payment awards which is expected to be recognized overa weighted-average amortization period of 2.04 years.
Prior to the IPO, the grant datefair market value of the shares of common stock underlying stock options had historically been determined by the Company’s Boardof Directors. Because there had been no public market for the Company’s common stock, the Board of Directors exercised reasonablejudgment and considered a number of objective and subjective factors to determine the best estimate of the fair market value, which includedvaluations performed by an independent third-party, important developments in the Company’s operations, sales of the Company’sconvertible preferred stock, actual operating results, financial performance, the conditions in the life sciences industry, the economyin general, the stock price performance and volatility of comparable public companies, and the lack of liquidity of the Company’scommon stock. For 2022 and 2023, the Company has used a comparative peer group for determining the expected volatility rate used in thecalculation of fair value. Since the Company’s stock has not been publicly traded for a sufficiently long period of time, the expectedvolatility rate is based on a review of the historical volatilities, over a period of time equivalent to the expected life of the instrumentbeing valued, of similarly positioned public companies within the Company’s industry.
The Company estimated the fair valueof share-based payment awards using the Black-Scholes options valuation model. The fair value of share-based payment awards is being amortizedon a straight-line basis over the requisite service period of the awards. The fair value of share-based payment awards was estimated onthe date of grant using the following assumptions:
2023 | 2022 | ||
Expected life (in years) | 5.71– 6.08 | 3.58– 6.08 | |
Expected volatility | 114.59% - 153.33% | 49.86% - 114.76% | |
Risk-free interest rate | 3.50% - 4.01% | 0.99% - 3.85% | |
Dividend yield | –% | –% |
Expected Term: The Companyuses the simplified method to calculate expected term described in the Securities and Exchange Commission’s Staff Accounting BulletinNo. 107, which takes into account vesting term and expiration date of the options.
Volatility: Volatility isbased on an average of the historical volatilities of comparable publicly traded companies for the expected term.
Risk Free Interest Rate:The risk-free rate is based on the U.S. Treasury yields in effect at the time of grant for periods corresponding with the expected termof the option.
Dividend Yield: The Companyhas never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and therefore, used anexpected dividend yield of zero in the valuation model.
No income tax benefits have beenrecognized relating to stock-based compensation expenses and no tax benefits have been realized from exercised stock options.
F-24 |
Total Stock-Based Compensation
Total stock-based compensation expenserecorded related to share-based payment awards was allocated to research and development, sales and marketing, and general and administrativeexpense as follows (in thousands):
2023 | 2022 | |||||||
Research and development | $ | 103 | $ | 114 | ||||
Sales and marketing | 1 | 4 | ||||||
General and administrative | 167 | 280 | ||||||
Total stock-based compensation | $ | 271 | $ | 398 |
12. | Income Taxes |
The provision for income taxes differs from the amountwhich would result by applying the federal statutory income tax rate to pre-tax loss for the years ended December 31, 2023 and 2022.
A reconciliation of the provision computed at the federalstatutory rate to the provision for income taxes included in the accompanying statements of operations for the Company is as follows.
For the Years Ended | ||||||||
December 31, 2023 | December 31, 2022 | |||||||
Income tax provision at statutory rate | 21% | 21% | ||||||
State income taxes, net of federal benefit | (15)% | 7% | ||||||
Research and development credits | (1)% | 1% | ||||||
Change in valuation allowance | (5)% | (29)% | ||||||
Effective income tax rate | –% | –% |
For the years ended December 31,2023 and 2022, the Company’s effective tax rate is below the federal statutory income tax rate of 21% primarily due to state incometaxes, net of federal benefit and the Company’s position to establish a full valuation allowance on its deferred tax assets.
F-25 |
The tax effects of temporary differences and carryforwardsthat give rise to significant portions of the net deferred tax assets are presented below (in thousands):
For the Years Ended | ||||||||
December 31, 2023 | December 31, 2022 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 6,759 | $ | 6,536 | ||||
Research and development credits | 186 | 231 | ||||||
Research and development costs | 465 | 292 | ||||||
Lease liability | 103 | 145 | ||||||
Other temporary differences | 158 | 159 | ||||||
Total deferred tax assets | 7,671 | 7,363 | ||||||
Valuation allowance | (7,574 | ) | (7,220 | ) | ||||
Deferred tax assets recognized | 97 | 143 | ||||||
Deferred tax liabilities: | ||||||||
Right-of-use assets | (97 | ) | (143 | ) | ||||
Total deferred tax liabilities | (97 | ) | (143 | ) | ||||
Net deferred tax assets | $ | – | $ | – |
The Company has recorded a valuationallowance for its deferred tax assets that it does not believe will be realizable at a more likely than not level based on analysis ofall available sources of taxable income. The valuation allowance increased by $354 thousand and $2.9 million for the years ended December31, 2023 and 2022, respectively, due to current and previous year losses and credits claimed.
At December 31, 2023 and 2022, theCompany had federal net operating loss carryforwards of approximately $30.4 million and $23.3 million, respectively, which will beginto expire in 2036. Approximately $29.9 million of federal net operating losses can be carried forward indefinitely. At December 31, 2023and 2022, the Company had state net operating loss carryforwards for California of approximately $5.1 million and $23.2 million, respectively,which will begin to expire in 2031. The Company also had federal and state research and development credit carryforwards of approximately$31 thousand and $296 thousand, respectively, at December 31, 2023. The federal credits start to expire in 2043. The California creditscarryforward indefinitely.
Federal and state tax laws imposesubstantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an “ownership change”for tax purposes, as defined in Section 382 of the Internal Revenue code. Accordingly, the Company’s ability to utilize these carryforwardsmay be limited as a result of such ownership changes. Such a limitation could result in limitation in the use of net operating lossesin future years and possibly a reduction of the net operating losses available. The Company has not performed a 382 study to determineif any ownership changes have occurred which could potentially limit the utilization of the tax attribute carryforwards.
F-26 |
A reconciliation of the beginningand ending amount of gross unrecognized tax positions is as follows (in thousands):
For the Years Ended | ||||||||
December 31, 2023 | December 31, 2022 | |||||||
Unrecognized tax benefits, beginning of year | $ | 115 | $ | 53 | ||||
Additions related to current year tax positions | (17 | ) | 62 | |||||
Net deferred tax assets | $ | 98 | $ | 115 |
During the year ended December 31,2023 the amount of unrecognized tax benefits decreased by $17 thousand due to current year research and development credits generatedduring the year offset by a reduction in research and development credits available for use due to application of the Section 382 limitations.During the year ended December 31, 2022 the amount of unrecognized tax benefits increased by $62 thousand due to additional researchand development credits generated during the year. As of December 31, 2023 and 2022, the total amount of unrecognized tax benefits was$98 thousand and $115 thousand, respectively. The reversal of the uncertain tax benefits would not affect the Company’s effectivetax rate to the extent that it continues to maintain a full valuation allowance against its deferred tax assets.
The Company recognizes interest andpenalties related to unrecognized tax benefits in the provision for income taxes line item in the statements of operations. As of December31, 2023, and 2022, the Company had not accrued any interest or penalties related to uncertain tax positions. The Company does not anticipateany material change in its unrecognized tax benefits over the next twelve months. The unrecognized tax benefits may change during thenext year for items that arise in the ordinary course of business.
The Company files tax returns inU.S. Federal and state jurisdictions. The tax periods from 2016 to 2023 remain open to examination in all jurisdictions. In addition,any tax losses that were generated in prior years and carried forward may also be subject to examination by the respective authorities.The Company is not currently under examination by income tax authorities for federal or state purposes.
13. | Net Loss per Share |
The following outstanding potentiallydilutive common stock equivalents have been excluded from the calculation of diluted net loss per share for the periods presented dueto their antidilutive effect:
For the Years Ended December 31, | ||||||||
2023 | 2022 | |||||||
Common stock warrants | 59,497 | 2,727 | ||||||
Common stock options issued and outstanding | 14,661 | 12,698 | ||||||
Total | 74,158 | 15,425 |
For the Years Ended December 31, | ||||||||
2023 | 2022 | |||||||
Net loss | $ | (8,244 | ) | $ | (10,096 | ) | ||
Weighted-average number of shares - basic and diluted | 793,043 | 96,778 | ||||||
Net loss per share - basic and diluted | $ | (10.40 | ) | $ | (104.32 | ) |
F-27 |
14. | Related Party Transactions |
In December 2021, the Company enteredinto an agreement with a significant shareholder for certain product development consultation services. During the years ended December31, 2023 and 2022, the Company incurred $14 thousand and $18 thousand, respectively, of expenses in connection with the agreement. Theexpenses are included in research and development expense. There were no unpaid balances due to the shareholder at December 31, 2023.
15. | Subsequent Events |
On March 5, 2024, the Company and ALOMentered into an amendment to the ALOM Agreement, pursuant to which ALOM agreed to waive the hourly account management charges and minimummonthly purchase requirements set forth in the ALOM Agreement for the period from January 2024 through June 2024, and the parties furtheragreed to extend the initial term of the agreement to December 31, 2024. The Company is currently evaluating alternative providers forthe services provided by ALOM as an effort to continue to further reduce both direct and indirect costs associated with product manufacturingand distribution.
F-28 |
Tivic Health Systems, Inc.
Condensed Balance Sheets (Unaudited)
June 30, 2024 and December 31, 2023
(in thousands,except share and per share data)
June30, | December31, | |||||||
2024 | 2023 | |||||||
ASSETS | ||||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 3,693 | $ | 3,395 | ||||
Accounts receivable, net | 16 | 174 | ||||||
Inventory, net | 766 | 756 | ||||||
Prepaid expenses and other current assets | 188 | 327 | ||||||
Total current assets | 4,663 | 4,652 | ||||||
Property and equipment, net | 120 | 122 | ||||||
Right-of-use assets, operating lease | – | 349 | ||||||
Other assets | – | 34 | ||||||
Total assets | $ | 4,783 | $ | 5,157 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 446 | $ | 713 | ||||
Other accrued expenses | 145 | 495 | ||||||
Operating lease liability, current | – | 193 | ||||||
Total current liabilities | 591 | 1,401 | ||||||
Operating lease liability | – | 176 | ||||||
Total liabilities | 591 | 1,577 | ||||||
Commitments and contingencies (Note 6) | ||||||||
Stockholders’ equity | ||||||||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2024 and December 31, 2023 | – | – | ||||||
Common stock, $0.0001 par value, 200,000,000 shares authorized; 6,183,592 and 1,466,092 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 1 | – | ||||||
Additional paid in capital | 44,824 | 41,466 | ||||||
Accumulated deficit | (40,633 | ) | (37,886 | ) | ||||
Total stockholders’ equity | 4,192 | 3,580 | ||||||
Total liabilities and stockholders’ equity | $ | 4,783 | $ | 5,157 |
The accompanying notes are an integral part ofthese unaudited condensed financial statements.
F-29 |
Tivic Health Systems, Inc.
Condensed Statements of Operations (Unaudited)
Three and Six Months Ended June 30, 2024and 2023
(in thousands,except share and per share data)
Three Months Ended | Six Months Ended | |||||||||||||||
June30, | June30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenue | $ | 140 | $ | 161 | $ | 474 | $ | 537 | ||||||||
Cost of sales | 110 | 100 | 277 | 363 | ||||||||||||
Gross profit | 30 | 61 | 197 | 174 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 302 | 468 | 558 | 958 | ||||||||||||
Sales and marketing | 207 | 452 | 712 | 910 | ||||||||||||
General and administrative | 727 | 1,266 | 1,614 | 2,547 | ||||||||||||
Total operating expenses | 1,236 | 2,186 | 2,884 | 4,415 | ||||||||||||
Loss from operations | (1,206 | ) | (2,125 | ) | (2,687 | ) | (4,241 | ) | ||||||||
Other expense: | ||||||||||||||||
Other expense | 60 | – | 60 | – | ||||||||||||
Total other expense | 60 | – | 60 | – | ||||||||||||
Net loss | $ | (1,266 | ) | $ | (2,125 | ) | $ | (2,747 | ) | $ | (4,241 | ) | ||||
Net loss per share - basic and diluted | $ | (0.32 | ) | $ | (7.16 | ) | $ | (1.00 | ) | $ | (17.01 | ) | ||||
Weighted-average number of shares - basic and diluted | 4,009,746 | 296,778 | 2,738,743 | 249,264 |
The accompanying notes are an integral part ofthese unaudited condensed financial statements.
F-30 |
Tivic Health Systems, Inc.
Condensed Statements of Stockholders’Equity (Unaudited)
Three and Six Months Ended June 30, 2024and 2023
(in thousandsexcept share and per share data)
For the Three and Six Months Ended June 30,2023
Additional | Total | |||||||||||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Accumulated | Stockholders’ | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||||||||
Balances at January 1, 2023 | – | $ | – | 96,778 | $ | – | $ | 33,272 | $ | (29,642 | ) | $ | 3,630 | |||||||||||||||
Issuance of common stock, net of issuance costs | 200,000 | – | 3,412 | – | 3,412 | |||||||||||||||||||||||
Issuance of warrants | – | – | – | – | 195 | – | 195 | |||||||||||||||||||||
Stock-based compensation expense | – | – | – | – | 84 | – | 84 | |||||||||||||||||||||
Net loss | – | – | – | – | – | (2,116 | ) | (2,116 | ) | |||||||||||||||||||
Balances at March 31, 2023 | – | $ | – | 296,778 | $ | – | $ | 36,963 | $ | (31,758 | ) | $ | 5,205 | |||||||||||||||
Stock-based compensation expense | – | – | – | – | 81 | – | 81 | |||||||||||||||||||||
Net loss | – | – | – | – | – | (2,125 | ) | (2,125 | ) | |||||||||||||||||||
Balances at June 30, 2023 | – | $ | – | 296,778 | $ | – | $ | 37,044 | $ | (33,883 | ) | $ | 3,161 |
For the Three and Six Months Ended June 30,2024
Additional | Total | |||||||||||||||||||||||||||
Preferred Stock | Common Stock | Paid-in | Accumulated | Stockholders’ | ||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||||||||
Balances at January 1, 2024 | – | $ | – | 1,466,092 | $ | – | $ | 41,466 | $ | (37,886 | ) | $ | 3,580 | |||||||||||||||
Issuance of common stock for restricted stock award | – | – | 7,500 | – | – | – | – | |||||||||||||||||||||
Stock-based compensation expense | – | – | – | – | 54 | – | 54 | |||||||||||||||||||||
Net loss | – | – | – | – | – | (1,481 | ) | (1,481 | ) | |||||||||||||||||||
Balances at March 31, 2024 | – | $ | – | 1,473,592 | $ | – | $ | 41,520 | $ | (39,367 | ) | $ | 2,153 | |||||||||||||||
Issuance of common stock and warrants, net of issuance costs and warrants issued to placement agents | – | – | 4,710,000 | 1 | 3,180 | – | 3,181 | |||||||||||||||||||||
Issuance of warrants | – | – | – | – | 70 | – | 70 | |||||||||||||||||||||
Stock-based compensation expense | – | – | – | – | 54 | – | 54 | |||||||||||||||||||||
Net loss | – | – | – | – | – | (1,266 | ) | (1,266 | ) | |||||||||||||||||||
Balances at June 30, 2024 | – | $ | – | 6,183,592 | $ | 1 | $ | 44,824 | $ | (40,633 | ) | $ | 4,192 |
The accompanying notes are an integral part ofthese unaudited condensed financial statements.
F-31 |
Tivic Health Systems, Inc.
Condensed Statements of Cash Flows (Unaudited)
Six Months Ended June 30, 2024 and 2023
(in thousands)
Six Months Ended | ||||||||
June30, | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (2,747 | ) | $ | (4,241 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock based compensation | 108 | 165 | ||||||
Depreciation | 2 | 6 | ||||||
Amortization of right-of-use asset | 76 | 85 | ||||||
Inventory allowances | 16 | – | ||||||
Bad debt expenses | 5 | – | ||||||
Non-cash gain on lease termination | (17 | ) | – | |||||
Changes is operating assets and liabilities: | ||||||||
Accounts receivable | 153 | 75 | ||||||
Inventory | (26 | ) | (125 | ) | ||||
Prepaid expenses and other current assets | 139 | (40 | ) | |||||
Accounts payable | (267 | ) | (492 | ) | ||||
Accrued expenses | (350 | ) | (229 | ) | ||||
Lease liabilities | (79 | ) | (70 | ) | ||||
Other assets | 34 | – | ||||||
Net cash used in operating activities | (2,953 | ) | (4,866 | ) | ||||
Cash flows from investing activities | ||||||||
Acquisition of property and equipment | – | (118 | ) | |||||
Net cash used in investing activities | – | (118 | ) | |||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | 3,251 | 4,191 | ||||||
Offering costs in advance of sale of common stock | – | (65 | ) | |||||
Net cash provided by financing activities | 3,251 | 4,126 | ||||||
Net change in cash and cash equivalents | 298 | (858 | ) | |||||
Cash and cash equivalents | ||||||||
Beginning of period | 3,395 | 3,517 | ||||||
End of period | $ | 3,693 | $ | 2,659 | ||||
Supplemental disclosure on noncash financing activities | ||||||||
Issuance of common stock warrant | $ | 70 | $ | 195 | ||||
Deferred offering costs charged to additional paid-in-capital | $ | – | $ | 584 | ||||
Write-off of ROU asset and lease liability | $ | 290 | $ | – |
The accompanying notes are an integral part ofthese unaudited condensed financial statements.
F-32 |
Tivic Health Systems, Inc.
Notes to Unaudited Condensed Financial Statements
(amountsare as indicated)
1. | Formation and Business of the Company |
Tivic Health Systems, Inc. (the “Company”)was incorporated in the state of California on September 22, 2016 for the purpose of developing and commercializing non-invasive bioelectronicmedicine. In June 2021, the Company was reincorporated as a Delaware corporation. The Company’s first commercial platform is a handhelddesign that interfaces non-invasively with the trigeminal, sympathetic, and other facial and cranial nerve structures. This platform isthe basis for the Company’s existing product, currently marketed with FDA approval as ClearUP Sinus Pain Relief, for the treatmentof sinus pain and congestion. The Company's second platform is a research-stage platform directed to vagus nerve stimulation, which iscurrently undergoing clinical evaluation. The Company is headquartered in Fremont, California.
2. | Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying condensed balance sheet as ofDecember 31, 2023, which has been derived from audited financial statements, and the unaudited interim condensed financial statementsas of June30, 2024, and for the three and six months ended June30, 2024 and June30, 2023, have been prepared in conformitywith accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information.Certain information and note disclosures normally included in annual financial statements prepared in accordance with generally acceptedaccounting principles have been condensed or omitted pursuant to those rules and regulations. In the opinion of management, all accountingentries and adjustments (including normal, recurring adjustments) considered necessary for a fair presentation of the financial positionand the results of operations for the interim periods have been made. Operating results for the three and six months ended June30,2024 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2024.
Going Concern Uncertainty
During thesix months ended June30, 2024 and 2023, the Company incurred a net loss of $2.7 million and $4.2 million, respectively. At June30,2024, the Company had an accumulated deficit of $40.6 million. Cash and cash equivalents at June30, 2024 were $3.7 million. Duringthe six month periods ended June30, 2024 and 2023, the Company had negative cash flows from operations of $3.0 million and$4.9 million, respectively. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a goingconcern within one year from the issuance date of the financial statements. The accompanying financial statements have been prepared ona going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classificationof liabilities that might be necessary should the Company be unable to continue as a going concern within one year after the date thefinancial statements are issued.
Future capital requirements will depend upon manyfactors, including, without limitation, progress with developing, manufacturing and marketing our technologies; the time and costs involvedin preparing, filing, prosecuting, maintaining and enforcing patent claims and other proprietary rights; our ability to establish collaborativearrangements; completion of any acquisitions or other strategic transactions; marketing activities and competing technological and marketdevelopments, including regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue andachieve profitability requires us to successfully market and secure purchase orders for our products and services from existing as wellas new customers. We also will be required to efficiently manufacture and deliver on those purchase orders. These activities, includingour planned research and development efforts, may require significant uses of working capital. There can be no assurance that we willgenerate revenue and cash as expected in our current business plan.
F-33 |
The Company recognizes it will need to raise additionalcapital to continue research and development and to fund its planned operations, clinical trials and, if regulatory approval is obtained,commercialization of future products. We may seek additional funds through equity or debt offerings and/or borrowings under notes payable,lines of credit or other sources. We do not know whether additional financing will be available on commercially acceptable terms, or atall, when needed. If adequate funds are not available or are not available on commercially acceptable terms, our ability to fund our operations,support the growth of our business or otherwise respond to competitive pressures could be significantly delayed or limited, which couldmaterially adversely affect our business, financial conditions, or results of operations.
Reverse Stock Split
In August 2023, the Company’s Board of Directorsand stockholders approved an amendment to the Company’s amended and restated certificate of incorporation to effect a 1-for-100reverse stock split of the issued and outstanding shares of the Company’s common stock, which was effected on August 23, 2023. Therewas no change to the par value, or authorized shares, of either the common stock or preferred stock, as a result of the reverse stocksplit. Fractional shares were not issued, and instead, the Company issued onewhole share of the post reverse split common stockto any stockholder who otherwise would have been entitled to receive a fractional share as a result of the reverse stock split. Consequently,84 shares of common stock were issued in lieu of fractional shares. In addition, all options, warrants and other convertible securitiesof the Company outstanding immediately prior to the reverse stock split were adjusted by dividing the number of shares of common stockinto which such options, warrants and other convertible securities were exercisable or convertible by 100 and multiplying the exerciseor conversion price thereof by 100, all in accordance with the terms of the plans, agreements or arrangements governing such options,warrants and other convertible securities and subject to rounding pursuant to such terms. All share and per share amounts for thecommon stock, as well as the stock options, and warrants outstanding and exercise prices thereof, included in the financial statementsand these footnotes thereto have been retroactively restated to give effect to the reverse stock split.
Use of Estimates
The preparation of financial statements in conformitywith GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosureof contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period.Actual results could differ materially from those estimates. The Company evaluates its estimates and assumptions on an ongoing basis usinghistorical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate.
Cash and Cash Equivalents
The Company considers all highly liquid investmentswith original maturities of three months or less at date of purchase to be cash equivalents. As of June30, 2024 and December 31,2023, cash and cash equivalents totaled $3.7 million and $3.4 million, respectively.
Accounts Receivable
Trade accounts receivable are recorded at theinvoiced amount, net of allowances for credit losses and returns reserves. The allowance for credit losses is based on our assessmentof the collectability of accounts. Management regularly reviews the adequacy of the allowance for credit losses by considering the ageof each outstanding invoice, each customer’s expected ability to pay, and the collection history with each customer, when applicable,to determine whether a specific allowance is appropriate. Accounts receivable deemed uncollectible are charged against the allowance forcredit losses when identified. As of each June30, 2024 and December 31, 2023, the allowance for credit losses balance was zero.
Inventory
Inventories are stated at the lower of cost ornet realizable value, with cost determined on a first-in, first-out (“FIFO”) basis. Inventories are reviewed periodicallyto identify slow-moving inventory based on anticipated sales activity. As of June30, 2024 and December 31, 2023, the reserve forobsolescence was $40 thousand and $32thousand, respectively.
F-34 |
Deferred Offering Costs
The Company complies with the requirements ofFinancial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”) 340-10-S99-1. The Companycapitalizes incremental legal, professional, accounting, and other third-party fees that are directly associated with an equity or debtoffering as other current assets. If the Company consummates an equity offering, the deferred financing costs will be allocated to additionalpaid-in capital. If the Company consummates a debt offering, the deferred financing costs will be recorded as a discount to the debt.
Property and Equipment
Property and equipment are recorded at cost netof accumulated depreciation. Depreciation is computed on a straight-line method over the estimated useful lives of the assets, three tofour years. Upon retirement or sale of assets, the cost and related accumulated depreciation are removed from the balance sheet and theresulting gain or loss is reflected in operations. Repairs and maintenance costs that do not improve or extend the lives of the respectiveassets are charged to operations as incurred.
Impairment of Long-Lived Assets
The Company evaluates its long-lived assets, includingproperty and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of these asset maynot be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset to the future undiscountedcash flows the asset is expected to generate over its remaining life. When indications of impairment are present and the estimated undiscountedfuture cash flows from the use of these assets is less than the assets’ carrying value, the related assets will be written downto fair value. There were no impairments of the Company’s long-lived assets for the periods presented.
Commitments and Contingencies
Liabilities for loss contingencies arising fromclaims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurredand the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred.
Revenue Recognition
The Company recognizes revenue from product salesin accordance with FASB ASC Topic 606, Revenue from Contracts with Customers (“Topic 606”). The standard applies to all contractswith customers, except contracts that are within scope of other standards, such as leases, insurance, collaboration arrangements and financialinstruments.
Under Topic 606, an entity recognizes revenuewhen its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expectsto receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are inwithin the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identifythe performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performanceobligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only appliesthe five-step model to contracts when it is probable the entity will collect the consideration it is entitled to in exchange for the goodsor services it transfers to the customer. At contract inceptions, once the contract is determined to be within the scope of Topic 606,the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesseswhether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that isallocated to the respective performance obligation when (or as) the performance obligation is satisfied.
F-35 |
The Company sells its products through directsales and resellers. Revenue is recognized when control of the promised goods is transferred to the customers or the resellers, in anamount that reflects the consideration the Company expects to be entitled to in exchange for those goods. Revenue associated with productsholding rights of return are recognized when the Company concludes there is not a risk of significant revenue reversal in the future periodsfor the expected consideration in the transaction.
The Company may receive payments at the onsetof the contract and before goods have been delivered. In such instances, the Company records a deferred revenue liability. The Companyrecognizes these contract liabilities as revenue after the revenue criteria are met. As of June30, 2024 and December 31, 2023, thecontract liability related to the Company’s deferred revenues approximated $4 thousand and $8thousand, respectively, and isincluded in “Other Accrued Expenses” on the accompanying balance sheets.
The Company relies on third parties to have proceduresin place to detect and prevent credit card fraud, as the Company has exposure to losses from fraudulent charges. The Company records thelosses related to chargebacks as incurred.
The Company has also elected to exclude from themeasurement of the transaction price sales taxes remitted to governmental authorities.
The table below presents revenue by channel forthe three and six months ended June30, 2024 and 2023 (in thousands):
Three Months Ended June30, | Six Months Ended June30, | |||||||||||||||
Product Revenue by Sales Channel | 2024 | 2023 | 2024 | 2023 | ||||||||||||
Product Revenue | ||||||||||||||||
Direct-to-consumer | $ | 126 | $ | 171 | $ | 427 | $ | 474 | ||||||||
Reseller | 32 | 11 | 94 | 109 | ||||||||||||
Returns | (18 | ) | (21 | ) | (47 | ) | (46 | ) | ||||||||
Revenue | $ | 140 | $ | 161 | $ | 474 | $ | 537 |
Sales Tax
Sales tax collected from customers and remittedto governmental authorities is accounted for on a net basis and therefore, is excluded from net sales.
Shipping and Handling
Shipping and handling fees paid by customers arerecorded in revenue, with the related expenses recorded in cost of sales. There were noshipping and handling fees paid by customersfor the three and six months ended June30, 2024 and 2023.
Shipping costs for delivery of product to customersin the three and six months ended June30, 2024 were $6 thousand and $23 thousand, respectively, and for the three and six monthsended June30, 2023 were $7 thousand and $22 thousand, respectively.
Product Warranty
The Company generally offers a one-year limitedwarranty on its products. The Company estimates the costs associated with the warranty obligation using historical data of warranty claimsand costs incurred to satisfy those claims. Estimated warranty costs are expensed to cost of sales.
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Returns
The Company estimates a reserve for future productreturns based on several factors, including historical returns as a percentage of revenue, an understanding of the reasons for past returnsand any other known factors that indicate a return is imminent. Reserves for sales returns are estimated and recorded in the sameperiod as the underlying revenue recognition as a deduction to arrive at net product sales and as a liability classified as“OtherAccrued Expenses” on the balance sheet. As of June30, 2024 and December 31, 2023, the reserve for sales returns was $8 thousandand $52 thousand, respectively.
Sales and Marketing Expenses
Sales and marketing expenses are expensed as incurredand consist primarily of merchandising, customer service and targeted online marketing costs, such as display advertising, keyword searchcampaigns, search engine optimization and social media and offline marketing costs such as television, radio and print advertising. Salesand marketing expenses also include payroll costs and stock-based compensation expense for employees involved in marketing activities.Sales and marketing expenses are primarily related to growing the customer base.
Research and Development Expenses
Research and development expenses include costsdirectly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits,materials, supplies, depreciation on and maintenance of research equipment, the cost of services provided by outside contractors, andthe allocable portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation, and general supportservices. All costs associated with research and development are expensed as incurred.
Stock-Based Compensation
The Company accounts for stock-based compensationarrangements with employees and non-employee consultants using a fair value method, which requires the recognition of compensation expensefor costs related to all stock-based payments, including stock options. The fair value method requires the Company to estimate the fairvalue of stock-based payment awards to employees and non-employees on the date of grant using an option pricing model.
Stock-based compensation costs are based on thefair value of the underlying option calculated using the Black-Scholes option-pricing model and recognized as expense on a straight-linebasis over the requisite service period, which is the vesting period. The Company measures equity-based compensation awards granted tonon-employees at fair value as the awards vest and recognizes the resulting value as compensation expense at each financial reportingperiod.
Determining the appropriate fair value model andrelated assumptions requires judgment, including estimating stock price volatility, expected dividend yield, expected term, risk-freerate of return, and the estimated fair value of the underlying common stock. Due to the lack of company-specific historical and impliedvolatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companiesthat are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption.The group of representative companies have characteristics similar to the Company, including stage of product development and focus onthe life science industry. The Company uses the simplified method, which is the average of the final vesting tranche date and the contractualterm, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to providea reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrument whose termis consistent with the expected term of the stock options. The Company uses an assumed dividend yield of zeroas the Company hasnever paid dividends and has no current plans to pay any dividends on its common stock. The Company accounts for forfeitures as they occur.
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Net Loss per Common Share
The Company computes net loss per share of commonstock in conformity with the two-class method required for participating securities. Diluted net loss per share is computed similar tobasic net loss per share, except that the denominator is increased to include the number of additional shares for the potential dilutiveeffects of warrants, convertible preferred stock and stock options outstanding during the period calculated in accordance with the treasurystock method, or the two-class method, whichever is more dilutive. For all periods presented, basic and diluted net loss per share isthe same, as inclusion of any additional share equivalents would be anti-dilutive.
Concentration of Credit Risk and Other Risksand Uncertainties
Financialinstruments that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents andaccounts receivable. Cash and cash equivalents include a checking account and a money market account held at one national financial institutionin the United States. At times, such deposits may be in excess of insured limits. Management believes that the financial institution atwhich the Company holds its deposits is financially sound, and accordingly, minimal credit risk exists with respect to the financial institution.The Company has not experienced any losses on its deposits of cash and cash equivalents. As of each June30, 2024 and December 31,2023, the Company had cash and cash equivalents balances exceeding FDIC insured limits by $3.2 million and $3.0 million, respectively.
The Companyextends credit to customers in the normal course of business and performs credit evaluations of its customers. Concentrations of creditrisk with respect to accounts receivable exist to the full extent of amounts presented in the financial statements.
During the first half of 2024, the majority, or81%, of the Company’s sales have been to individual customers. In 2023, the majority, or 81%, of the Company’s sales wereto individual consumers. As of June30, 2024, the Company had no reseller customers whose accounts receivable balance totaled morethan 10% or more of the Company’s total accounts receivable compared with one such customer at December 31, 2023 (81%).
For the three months ended June30, 2024,the Company had one customer who individually accounted for 10% or more of the Company’s total revenue (23%). For the three monthsended June30, 2023, the Company had no customer who individually accounted for 10% or more of the Company’s total revenue.
For the six months ended June30, 2024, theCompany had one customer who individually accounted for 10% or more of the Company’s total revenue (13%) compared to one customerfor the six months ended June30, 2023 (16%).
The lingeringnegative impacts of the COVID-19 pandemic, the ongoing conflicts between Russia and Ukraine as wellas Israel and Hamas, certain other macroeconomic factors including inflation, and rising interest rates, have contributed to economicuncertainty. Additionally, events involving limited liquidity, defaults, non-performance or otheradverse developments that affect financial institutions or the financial services industry generally, or concerns or rumors about anyevents of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. Furthermore,it is possible that U.S. policy changes, including changes and uncertainty as a result of the upcoming U.S. presidential election, couldincrease market volatility in the coming months. These factors, amongst other things, could resultin further economic uncertainty and volatility in the capital markets in the near term, and could negatively affect our operations. Wewill continue to monitor material impacts on our business strategies and operating results.
F-38 |
Recently Issued Accounting Pronouncements
In November 2023, the Financial Accounting StandardsBoard (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280) - Improvementsto Reportable Segment Disclosures. The guidance, which becomes effective for fiscal years beginning after December 15, 2023 and interimperiods within fiscal years beginning after December 15, 2024, requires public entities that are required to report segment informationin accordance with Topic 280, Segment Reporting, to improve reportable segment disclosures about significant segment expenses. We do notbelieve that ASU 2023-07 will have a material impact on our reporting as we operate in one reportable segment.
In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740)- Improvements to Income Tax Disclosures. The guidance applies to all entities that are subject to Topic740, Income taxes and becomes effective for public business entities for annual periods beginning after December 15, 2024 and interimperiods within fiscal years beginning after December 15, 2024. The guidance requires enhanced disclosures related to income taxes including:additional information in the rate reconciliation; further breakdown of income taxes paid; and other disclosures that may help investorsto better understand the entities tax landscape. We do not believe that ASU 2023-09 will have a material impact on our financial reporting.
3. | Financial Instruments and Fair Value Measurements |
The Company’s financial instruments consistof money market funds. The following tables show the Company’s cash equivalents carrying value and fair value at June30, 2024and December 31, 2023 (in thousands):
As of June 30, 2024 (unaudited) | ||||||||||||||||||||
Quoted | Significant | |||||||||||||||||||
Priced in | other | Significant | ||||||||||||||||||
active | observable | unobservable | ||||||||||||||||||
Carrying | Fair | markets | inputs | inputs | ||||||||||||||||
Amount | Value | (Level 1) | (Level 2) | (Level 3) | ||||||||||||||||
Assets | ||||||||||||||||||||
Money market funds | $ | 3,238 | $ | 3,238 | $ | 3,238 | $ | – | $ | – | ||||||||||
Total assets | $ | 3,238 | $ | 3,238 | $ | 3,238 | $ | – | $ | – |
As of December31, 2023 | ||||||||||||||||||||
Quoted | Significant | |||||||||||||||||||
Priced in | other | Significant | ||||||||||||||||||
active | observable | unobservable | ||||||||||||||||||
Carrying | Fair | markets | inputs | inputs | ||||||||||||||||
Amount | Value | (Level 1) | (Level 2) | (Level 3) | ||||||||||||||||
Assets | ||||||||||||||||||||
Money market funds | $ | 3,243 | $ | 3,243 | $ | 3,243 | $ | – | $ | – | ||||||||||
Total assets | $ | 3,243 | $ | 3,243 | $ | 3,243 | $ | – | $ | – |
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Cash equivalents – Cash equivalents of $3.2million as of each June30, 2024 and December 31, 2023, consisted of money market funds. Money market funds are classified as Level1 of the fair value hierarchy because they are valued using quoted market prices in active markets.
Certain assets and liabilities are carried atfair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability(an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participantson the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the useof unobservable inputs.
There have been no changes to the valuation methodologiesutilized by the Company during the six months ended June30, 2024 compared to the year ended December 31, 2023. The Company evaluatestransfers between levels at the end of each reporting period. There were no transfers of financial instruments between levels during thesix months ended June30, 2024 and the year ended December 31, 2023.
4. | Inventory, net (in thousands) |
June30, | December31, | |||||||
2024 | 2023 | |||||||
(unaudited) | ||||||||
Raw materials | $ | 526 | $ | 752 | ||||
Work in process | 5 | – | ||||||
Finished goods | 275 | 36 | ||||||
Inventory at cost | 806 | 788 | ||||||
Less reserve for obsolescence | (40 | ) | (32 | ) | ||||
Inventory, net | $ | 766 | $ | 756 |
5. | Property and equipment, net (in thousands) |
June30, 2024 | December31, 2023 | |||||||
Computers and equipment | $ | 11 | $ | 11 | ||||
Manufacturing tools and dies | 148 | 148 | ||||||
Total property and equipment | 159 | 159 | ||||||
Less accumulated depreciation | (39 | ) | (37 | ) | ||||
Property and equipment, net | $ | 120 | $ | 122 |
Depreciation expense was $1 thousand and $3 thousandfor the three months ended June30, 2024 and 2023, respectively, and was $2 thousand and $6 thousand for the six months ended June30,2024 and 2023, respectively.
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6. | Commitments and Contingencies |
Lease
The Company executed a noncancelable operatinglease for approximately 9,091 square feet of office space in Hayward, California in November 2021 as its headquarters. The lease was setto expire in October 2025. The Company was obligated to pay, on a pro-rata basis, real estate taxes and operating costs related to thepremises. Upon lease execution, the Company evaluated the lease and determined it should be capitalized as an operating lease.Asthere was no interest rate implicit in the lease, the Company estimated the incremental borrowing rate at 6% based on the rate availableunder its revolving credit line, as well as an assessment of the Company’s risk based on its financial position at the timeand its potential to obtain a collateralized loan for a period similar to the lease term. The lease was terminated effective May 31, 2024.The Company incurred termination fees of $77 thousand, which were partially offset by a remaining security deposit of $16 thousand. TheCompany recorded a loss of $60 thousand in connection with the lease termination, which is included in other expense in the statementof operations.
Lease costs for the three and six months endedJune30, 2024 were $33 thousand and $84 thousand, respectively, and for the three and six months ended June30, 2023 were $50thousand and $101 thousand, respectively.
Cash paid for amounts included in the measurementof operating lease liabilities were $34 thousand and $87 thousand for the three and six months ended June30, 2024, respectively,which is included in operating activities in the statement of operations. Cash paid for amounts included in the measurement of operatinglease liabilities were $52 thousand and $103 thousand for the three and six months ended June30, 2023, respectively, which is includedin operating activities in the statement of operations.
In June 2024, the Company entered into a short-termrental agreement for office space located in Fremont, California. The Company evaluated the agreement and determined the short-term rentalagreement does not meet the criteria for capitalization. Monthly rent payments required are $1 thousand per month and the agreement terminateson December 1, 2024. After expiration of the initial term, the agreement will automatically renew on a month to month basis until terminatedby either party upon 30 days' advance written notice.
ALOM Fulfillment Services Agreement
On November 25, 2022, the Company entered intoa Fulfillment Services Agreement (the “ALOM Agreement”), with ALOM Technologies Corporation (“ALOM”). Pursuantto the ALOM Agreement, commencing on November 28, 2022, ALOM began providing, on a non-exclusive basis, certain assembly, procurement,storage, returns, and fulfillment services to our end customers and retailers within the United States. During the term of the ALOM Agreement,ALOM shall provide the services in accordance with purchase orders issued by us from time to time. The consideration payable by us toALOM for services rendered under the ALOM Agreement will be calculated and invoiced based on fixed hourly rates and fixed unit pricing,as applicable, subject to certain exceptions; provided that, commencing April 1, 2023, we became subject to $25thousand minimummonthly purchase requirement. The ALOM Agreement has a three-year initial term, with automatic annual renewals, and may be terminatedfor convenience by either party upon sixty days written notice to the other party. On March 5, 2024, the ALOM Agreement was amended towaive hourly account management charges and minimum monthly purchase requirements for the period from January 2024 through June 2024,and to extend the initial term of the agreement to December 31, 2024. The ALOM Agreement was terminated after the quarter ended June 30,2024, as discussed in Note 13, below.
Contingencies
From time to time, the Company may have certaincontingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matterswhen future expenditures are probable and such expenditures can be reasonably estimated. The Company recorded no liabilities for contingentmatters as of June30, 2024.
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7. | Other Accrued Expenses (in thousands) |
June30, 2024 | December31, 2023 | |||||||
Accrued payroll and related | $ | 70 | $ | 218 | ||||
Delaware franchise tax | – | 160 | ||||||
Research study costs | 41 | 51 | ||||||
Other | 34 | 66 | ||||||
Total other accrued expenses | $ | 145 | $ | 495 |
8. | Preferred Stock |
There were no series of preferred stock designatedand no shares issued or outstanding at June30, 2024 and December 31, 2023.
The Company’s board of directors is authorized,without action by its stockholders, to designate and issue up to 10,000,000 shares of preferred stock in one or more series, and to fixthe voting rights, designations, powers, preferences, the relative, participating, optional or other special rights, if any, and any qualifications,limitations and restrictions thereof, applicable to the shares of any series of preferred stock that they may designate in the future.
9. | Common Stock |
At June30, 2024 and December 31, 2023, therewere 6,183,592 and 1,466,092shares of Company common stock issued and outstanding, respectively.
On February 13, 2023, the Company sold 200,000sharesof its common stock in an underwritten public offering at a price of $25per share, less underwriting discounts and commissions,resulting in gross proceeds to the Company of $5.0 million. The net proceeds to the Company, after deducting the underwriting discountand commissions and expenses paid by the Company, was approximately $3.6million. In addition, pursuant to the underwriting agreemententered into in connection with the offering, the Company granted the underwriter a 45-day option to purchase up to an additional 30,000sharesof common stock, solely to cover over-allotments. This option expired in March 2023, and the underwriter did not exercise its option topurchase any additional shares prior to such expiration. Additionally, as partial consideration for services rendered in connection withthe offering, the Company issued warrants to purchase an aggregate of 10,000shares of Company common stock to designees of ThinkEquityLLC (“ThinkEquity”). The designees paid an aggregate of $100 for the warrants. The warrants have an initial exercise priceof $31.25per share, have a term of four years from the commencement of sales in the offering, and are exercisable commencing sixmonths from closing.
On July 11, 2023, the Company sold 325,000 sharesof its common stock to certain investors at a price of $5.50 per share, resulting in gross proceeds to the Company of approximately $1.8million. Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, was approximately$1.5million. As compensation for services rendered by the placement agent, the Company paid the placement agent a cash fee of 8.0%of the aggregate gross proceeds of the offering (amounting to $143thousand) at closing, as well as $90thousand for the reimbursementof certain expenses. Additionally, as partial consideration for services rendered in connection with the offering, the Company issuedthe placement agent unregistered warrants to purchase an aggregate of 13,000shares of Company common stock, representing 4.0% ofthe aggregate shares sold in the offering. The warrants have an initial exercise price of $6.60per share (equal to 120% of the offeringprice per share), have a term of five years from the commencement of sales in the offering, and are exercisable commencing six monthsfrom closing.
F-42 |
On July 19, 2023, the Company sold 512,500sharesof its common stock to certain investors at a price of $4.00per share, resulting in gross proceeds to the Company of approximately$2.1million. Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, was approximately$1.7million. As compensation for services rendered by the placement agent, the Company paid the placement agent a cash fee of 8.0%of the aggregate gross proceeds of the offering (amounting to $164thousand) at closing, as well as $60 thousand for the reimbursementof certain expenses. Additionally, as partial consideration for services rendered in connection with the offering, the Company issuedthe placement agent unregistered warrants to purchase an aggregate of 20,500shares of common stock, representing 4.0% of the aggregateshares sold in the offering. The warrants have an initial exercise price of $4.80per share (equal to 120% of the offering priceper share), have a term of five years from the commencement of sales in the offering, and are exercisable commencing six months from closing.
On August 9, 2023, the Company sold 331,730sharesof its common stock to certain investors at a price of $4.10 per share, resulting in gross proceeds to the Company of approximately $1.4million.Net proceeds to the Company, after deducting placement agent fees and offering expenses paid by the Company, was approximately $1.1million.Ascompensation for services rendered by the placement agent, the Company paid the placement agent a cash fee of 8.0% of the aggregate grossproceeds of the offering (amounting to approximately $109thousand) at closing, as well as $60thousand for the reimbursementof certain expenses. Additionally, as partial consideration for services rendered in connection with the offering, the Company issuedthe placement agent unregistered warrants to purchase an aggregate of 13,270shares of Company common stock, representing 4.0% ofthe aggregate shares sold in the offering. The warrants have an initial exercise price of $4.92per share (equal to 120% of the offeringprice per share), have a term of five years from the commencement of sales in the offering, and are exercisable commencing six monthsfrom closing.
Effective August 23, 2023, the Company’sboard of directors approved a reverse stock split of the Company’s issued and outstanding shares of common stock, par value $0.0001pershare, at a ratio of 1-for-100.As a result of the reverse stock split, the total number of shares of common stock held by each stockholderof the Company were converted automatically into the number of shares of common stock equal to the number of issued and outstanding sharesof common stock held by each such stockholder immediately prior to the reverse stock split divided by 100. The Company issued one wholeshare of the post reverse stock split common stock to any stockholder who otherwise would have been entitled to receive a fractional shareas a result of the reverse stock split. As a result,no fractional shares were issued in connection with the reverse stock splitand no cash or other consideration was paid in connection with any fractional shares that would otherwise have resulted from the reversestock split. Also, all options, warrants and other convertible securities of the Company outstanding immediately prior to the reversestock split were adjusted by dividing the number of shares of common stock into which such options, warrants and other convertible securitieswere exercisable or convertible by 100 and multiplying the exercise or conversion price thereof by 100, all in accordance with the termsof the plans, agreements or arrangements governing such options, warrants and other convertible securities and subject to rounding pursuantto such terms. There was no change to the par value, or authorized shares, of either the common stock or preferred stock, as a resultof the reverse stock split. All share and per share amounts for the common stock, as well as the warrants outstanding and exercise pricesthereof, have been retroactively restated to give effect to the reverse stock split.
On May 13, 2024, the Company sold 4,710,000 sharesof its common stock, together with an aggregate of 4,710,000 Series A warrants (the “Series A Warrants”) to purchase up to4,710,000 shares of common stock and 7,065,000 Series B warrants (the “Series B Warrants” and collectively with the SeriesA Warrants, the “Common Warrants”) to purchase up to 7,065,000 shares of common stock, to certain investors in a registeredpublic offering. Each share of common stock was sold together with one Series A Warrant and one and a half Series B Warrants at a combinedprice of $0.85 per share and Common Warrants, resulting in gross proceeds to the Company of approximately $4 million. Net proceeds tothe Company, after deducting placement agent fees and offering expenses paid by the Company, was approximately $3.3 million.Thenet proceeds were allocated between the common stock and Common Warrants issued in the offering based on the relative fair values, whichwere $1.4 million and $1.9 million, respectively. Each of the Common Warrants are exercisable immediately upon issuance and have an exerciseprice of $0.85 per share, subject to certain adjustments. The Series A Warrants will expire one year from the date of issuance and theSeries B Warrants will expire five years from the date of issuance. As compensation for services rendered by the placement agent, theCompany paid the placement agent a cash fee of 7.0% of the gross proceeds of the offering (amounting to approximately $280 thousand) atclosing, as well as $100 thousand for the reimbursement of certain expenses. Additionally, as partial consideration for services renderedin connection with the offering, the Company issued the placement agent registered warrants to purchase an aggregate of 188,400 sharesof Company common stock, equal to 4.0% of the aggregate shares of common stock sold in the offering. The placement agent warrants havean initial exercise price of $0.935 per share (equal to 110% of the combined offering price per share and Common Warrants), have a termof five years from the commencement of sales in the offering, and are exercisable commencing six months from closing.
F-43 |
Common stockholders are entitled to dividendsif and when declared by the Board of Directors subject to the rights of the preferred stockholders. As of June30, 2024, no dividendson common stock had been declared by the Company. At June30, 2024 and December 31, 2023, the Company had reserved shares of commonstock for issuance as follows:
June30, | December31, | |||||||
2024 | 2023 | |||||||
Warrants to purchase common stock | 12,022,897 | 59,497 | ||||||
Options issued and outstanding | 54,369 | 14,661 | ||||||
Shares available for future stock option grants | 32,786 | 7,190 | ||||||
Total | 12,110,052 | 81,348 |
10. | Common Stock Warrants |
Historically, the Company has entered into warrantagreements in connection with certain consulting agreements and equity offerings. In August 2023, the Company implemented a 1-for-100reverse stock split wherein, per the terms of the agreements, the number of shares of common stock issuable upon exercise of each of thewarrants outstanding at that time was reduced by dividing the quantity outstanding by 100 and the exercise price of each such warrantwas multiplied by 100. No other terms of the warrants were changed as a result of the reverse stock split.
In July 2021, the Company entered into a consultingagreement, pursuant to which warrants to purchase 500shares of common stock were granted and an additional warrants to purchase500shares of common stock were granted in November 2021. The warrants are exercisable upon issuance, have an exercise price of $104pershare and have a term of five years. The consulting agreement was effective as of February 2021, had an initial monthly fee of $5thousandand a term of two years. The agreement was amended in May of 2022 to increase the monthly payment to $7.5 thousand. Currently, the agreementis automatically renewing on a month-to-month basis until terminated by either party. The warrant issuances are indexed to, and settledin, the Company’s own common stock and were classified within stockholders’ equity.
In November 2021, the Company issued warrantsto purchase 1,727 shares of common stock to designees of ThinkEquity, the underwriter of the Company’s initial public offering.The warrants may be exercised at any time on or after May 9, 2022, have an exercise price of $625 per share and have a term of five years.The warrant issuances are indexed to and settled in the Company’s own common stock and were classified within stockholders’equity.
In February 2023, the Company issued warrantsto purchase 10,000 shares of common stock to designees of ThinkEquity, the underwriter of the underwritten public offering of 200,000shares of Company common stock that closed in February 2023. The designees paid an aggregate of $0.1 thousand for the warrants. The warrantsmay be exercised at any time on or after August 7, 2023, have an exercise price of $31.25 per share, and have a term of four years commencing180 days following the commencement of sales in the offering. The warrant issuances were indexed to and settled in the Company’sown stock and were classified within stockholders’ equity.
In July and August 2023, the Company issued warrantsto purchase a total of 47,670 shares of common stock to Maxim Group LLC (“Maxim”), the placement agent for each of the threepublic offerings of the Company’s common stock completed during the period. The warrants are exercisable at any time beginning sixmonths after the closing date of the applicable equity offering and expire five years from the commencement of sales under the applicableoffering. Of the warrants issued in the offerings, 13,000 are exercisable beginning on January 11, 2024 at a price of $6.60 per share;20,500 are exercisable beginning on January 19, 2024 at a price of $4.80 per share; and 13,270 are exercisable beginning on February 9,2024 at a price of $4.92 per share.
F-44 |
The Company estimated the value of the warrantsin 2023 using the Black-Scholes options valuation model. The fair value of the warrants issued in February 2023 was $195 thousand andwas recognized as issuance costs of the common stock issued in the underwritten public offering and was classified within stockholders’equity. The fair value of the warrants issued in July and August 2023 totaled $168 thousand and was recognized as issuance costs of thecommon stock issued in the three public offerings during the period and was classified within stockholders’ equity.
In May 2024, in connection with the sale of 4,710,000shares of common stock, the Company issued Series A Warrants to purchase an aggregate of 4,710,000 shares of common stock and Series BWarrants to purchase an aggregate of 7,065,000 shares of common stock to the purchasers of the stock. The warrants are exercisable uponissuance and have an exercise price of $0.85 per share. The Series A Warrants expire on May 13, 2025 and the Series B Warrants expireon May 14, 2029. Additionally, the Company issued warrants to purchase 188,400 shares of common stock to Maxim, the placement agent forthe public offering of the Company’s securities. The placement agent warrants are exercisable at any time beginning six months afterthe closing date of the equity offering and expire five years from the from the commencement of sales under the offering.
The Company estimated the value of the warrants issuedto the placement agent in May 2024 using the Black-Scholes options valuation model. The fair value of the warrants issued in May 2024was $70 thousand and was recognized as issuance costs of the common stock issued in the public offering and was classified within stockholders'equity.
The fair value of the warrants issued to placementagents in 2024 and 2023 was estimated on the date of grant using the following assumptions:
2024 | 2023 | |||||||||||||||
Minimum | Maximum | Minimum | Maximum | |||||||||||||
Expected life (in years) | 5.0 | 5.0 | 4.0 | 5.0 | ||||||||||||
Expected volatility | 118.6% | 118.6% | 116.1% | 123.9% | ||||||||||||
Risk-free interest rate | 4.50% | 4.50% | 3.98% | 4.24% | ||||||||||||
Dividend yield | 0% | 0% | 0% | 0% |
A summary of the Company’s outstanding warrantsas of June30, 2024 is as follows:
Class of Shares | Number of Warrants | Exercise Price | Expiration Date | |||||||
Common Stock | 500 | $ | 104.00 | July 1, 2026 | ||||||
Common Stock | 500 | $ | 104.00 | November 15, 2026 | ||||||
Common Stock | 1,727 | $ | 625.00 | November 10, 2026 | ||||||
Common Stock | 10,000 | $ | 31.25 | August 9, 2027 | ||||||
Common Stock | 13,000 | $ | 6.60 | July 10, 2028 | ||||||
Common Stock | 20,500 | $ | 4.80 | July 14, 2028 | ||||||
Common Stock | 13,270 | $ | 4.92 | August 4, 2028 | ||||||
Common Stock | 188,400 | $ | 0.935 | May 9, 2029 | ||||||
Common Stock | 4,710,000 | $ | 0.85 | May 13, 2025 | ||||||
Common Stock | 7,065,000 | $ | 0.85 | May 14, 2029 | ||||||
Total | 12,022,897 |
F-45 |
11. | Equity Incentive Plans |
In 2017, the Company adopted its 2017 Equity IncentivePlan (the “2017 Plan”).
On November 10, 2021, the 2017 Plan terminatedand was replaced by the 2021 Plan (defined below), and future issuances of incentive instruments will be governed by the 2021 Plan. Tothe extent that outstanding awards under the 2017 Plan are forfeited or lapse unexercised, the shares of common stock subject to suchawards will no longer be available for future issuance.
2021 Equity Incentive Plan
In 2021, the Company adopted the 2021 Equity IncentivePlan (the “2021 Plan”). Options granted under the 2021 Plan may be Incentive Stock Options or Non-statutory Stock Options,as determined by the Compensation Committee of the Company’s board of directors, who is responsible for administering the 2021 Plan.Stock Purchase Rights may also be granted under the 2021 Plan. The term shall be no more than ten years from the date of grant thereof.In the case of an Incentive Stock Option granted to an optionee who, at the time the option is granted, owns stock representing more than10% of the voting power of all classes of stock of the Company or any Parent or Subsidiary, the term of the option shall be five yearsfrom the date of grant or such shorter term as may be provided in the option Agreement. To the extent outstanding awards under the 2021Plan are forfeited or lapse unexercised, the shares of common stock subject to such awards will be available for future issuance underthe 2021 Plan. The 2021 Plan provides that additional shares will automatically be added to the shares authorized for issuance under the2021 Plan on January 1 of each year. The number of shares added each year will be equal to the lesser of: (i) 5.0% of the outstandingshares of the Company’s common stock on December 31st of the preceding calendar year or (ii) such number of shares determined bythe board of directors, in its discretion. On January 1, 2023, 4,839 shares were automatically added to the number of shares authorizedfor issuance under 2021 Plan (an increase equal to 5% of the number of the outstanding shares of Company common stock as of December 31,2022). On January 1, 2024, 73,304 shares were automatically added to the number of shares authorized for issuance under 2021 Plan (anincrease equal to 5% of the number of the outstanding shares of Company common stock as of December 31, 2023).
In the case of an incentive stock option (i) grantedto an employee who, at the time of grant of such option, owns stock representing more than 10% of the voting power of all classes of stockof the Company or any parent or subsidiary of the Company, the exercise price shall be no less than 110% of the fair market value pershare on the date of grant; (ii) granted to any other employee, the per share exercise price shall be no less than 100% of the fair marketvalue per share on the date of grant. In the case of a non-statutory stock option (i) granted to an employee who, at the time of grantof such option, owns stock representing more than 10% of the voting power of all classes of stock of the Company or any parent or subsidiaryof the Company, the exercise price shall be no less than 110% of the fair market value per share on the date of grant; (ii) granted toany other service provider, the per share exercise price shall be no less than 100% of the fair market value per share on the date ofgrant. Notwithstanding the foregoing, options may be granted with a per share exercise price other than as required above pursuant toa merger or other corporate transaction.
The options may include provisions permittingexercise of the option prior to full vesting. Any unvested shares upon termination shall be subject to repurchase by the Company at theoriginal exercise price of the option.
As of June30, 2024, there were 32,786 sharesof common stock available for issuance under the 2021 Plan.
Stock options granted under the Company’sequity incentive plans generally vest over four years from the date of grant.
F-46 |
The following table summarizes the stock optionaward activity for the six months ended June30, 2024:
Outstanding | Exercisable | |||||||
January 1, 2024 | 14,661 | 6,110 | ||||||
Granted | 42,000 | – | ||||||
Vested | – | 2,201 | ||||||
Canceled or expired | (2,292 | ) | (781 | ) | ||||
Exercised | – | – | ||||||
June 30, 2024 | 54,369 | 7,530 |
The weighted-average exercise price as of June30,2024 for stock options outstanding and stock options exercisable was $34.52 and $169.76, respectively. The weighted average remainingcontractual life as of June30, 2024 for stock options outstanding and stock options exercisable was 9.03 and 6.26 years, respectively.
The following table sets forth the status of theCompany’s non-vested restricted common stock awards:
Weighted-Average | ||||||||
Number of | Grant Date | |||||||
Shares | Fair Value Per Share | |||||||
January 1, 2024 | – | $ | – | |||||
Issuance of restricted common stock | 7,500 | $ | 1.34 | |||||
Vested | (1,875 | ) | $ | 1.34 | ||||
Cancelled | – | $ | – | |||||
June 30, 2024 | 5,625 | $ | 1.34 |
There were no restricted stock awards outstandingduring the year ended December 31, 2023.
Stock-Based Compensation
Total stock-based compensation recorded in thecondensed statements of operations is allocated as follows (in thousands):
Three Months Ended | Six Months Ended | |||||||||||||||
June30, | June30, | |||||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Research and development | $ | 23 | $ | 27 | $ | 45 | $ | 58 | ||||||||
Sales and marketing | 1 | 1 | 1 | 3 | ||||||||||||
General and administrative | 30 | 53 | 62 | 104 | ||||||||||||
Total stock-based compensation | $ | 54 | $ | 81 | $ | 108 | $ | 165 |
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12. Net Loss per Share
The following outstanding potentially dilutivecommon stock equivalents have been excluded from the calculation of diluted net loss per share for the periods presented due to theirantidilutive effect:
Six Months Ended | ||||||||
June30, | ||||||||
2024 | 2023 | |||||||
Warrants to purchase common stock | 12,022,897 | 12,727 | ||||||
Common stock options issued and outstanding | 54,369 | 16,435 | ||||||
Total | 12,077,266 | 29,162 |
13. Subsequent Events
Termination of ALOM Agreement
Effective August 1, 2024, the Company terminated theALOM Agreement, pursuant to which ALOM provided, on a non-exclusive basis, certain assembly, procurement, storage, returns, and fulfillmentservices (collectively, the “Services”) to the Company’s end customers and retailers within the United States. The Companyterminated the Agreement for convenience, in accordance with the terms of the ALOM Agreement, in furtherance of its efforts to continueto reduce both direct and indirect costs associated with product manufacturing and distribution. The Company did not incur any materialearly termination penalties in connection with the termination of the ALOM Agreement. The Company is now utilizing third-party logisticsand storage services from alternate suppliers without material minimums and has established in-house assembly and testing capabilities.The Company completed the transition with no disruptions to service and foresees current capacity will be sufficient to meet demand forthe foreseeable future.
Amended and Restated 2021 Equity IncentivePlan
On August 9, 2024, the Company adoptedits Amended and Restated 2021 Equity Incentive Plan (the “A&R 2021 Plan”), which amends and restates the 2021 Plan infull to, amongst other things, increase the number of shares of common stock authorized for issuance thereunder from 92,376 shares to1,000,000 shares. The Company’s Board of Directors unanimously approved the adoption of the A&R 2021 Plan, subject to stockholderapproval, on June 15, 2024, and the Company’s stockholders approved the A&R 2021 Plan at the Company’s 2024 Annual Meetingof Stockholders held on August 9, 2024.
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107 |
108 |
* | Furnished herewith. | |
# | Indicates managementcontract or compensatory plan. | |
† | Portions of the exhibit, marked by brackets, have been omitted because the omitted information (i) isnot material and (ii) would likely cause competitive harm if publicly disclosed. |
109 |
Pursuant to the requirementsof Regulation A, the issuer certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form1-A and has duly caused this offering statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the Cityof Fremont, State of California, on August 16, 2024.
TIVIC HEALTH SYSTEMS, INC. | ||
By: | /s/ Jennifer Ernst | |
Jennifer Ernst Chief Executive Officer |
This Offering Statement hasbeen signed by the following persons in the capacities and on the dates indicated.
NAME | TITLE | DATE | ||
/s/ Jennifer Ernst | Chief Executive Officer | August 16, 2024 | ||
Jennifer Ernst | (Principal Executive) | |||
/s/ Kimberly Bambach | Interim Chief Financial Officer | August 16, 2024 | ||
Kimberly Bambach | (PrincipalFinancial and Accounting Officer) | |||
/s/ Sheryle Bolton | Chair of the Board of Directors | August 16, 2024 | ||
Sheryle Bolton | ||||
/s/ Karen Drexler | Director | August 16, 2024 | ||
Karen Drexler | ||||
/s/ Dean Zikria | Director | August 16, 2024 | ||
Dean Zikria | ||||
/s/ Christina Valauri | Director | August 16, 2024 | ||
Christina Valauri |
110 |
Exhibit11.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTINGFIRM
We consent the use in this Offering Statementon Form 1-A of Tivic Health Systems, Inc., of our report dated March 25, 2024 (which includes an explanatory paragraph relating to TivicHealth Systems, Inc’s ability to continue as a going concern) related to our audit of the financial statements of Tivic Health Systems,Inc., as of and for the years ended December 31, 2023 and 2022.
We also consent to the reference to us under theheading “Experts” in such Offering Statement.
/s/ Rosenberg Rich Baker Berman, P.A.
Somerset, New Jersey
August 16, 2024