Tivic Health Systems, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 14, 2025
VBIO$0.51+1.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0000950170-25-072752
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0000950170-25-108977
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 171 previous paragraphs and 169 current paragraphs.
74 unchanged; 69 reworded; 20 added; 28 removed; 0 previous and 6 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (20)
Current report
Clinical Pipeline
Current report
Toll-like Receptor 5 Agonist
Current report
As announced in February 2025, we recently acquired worldwide exclusive license rights from Statera Biopharma, Inc. (“Statera”) to the late-stage TLR5 agonist Entolimod for the treatment of ARS. In addition, we acquired an exclusive option to license five additional indications and clinical use cases for Entolimod and immune-optimized second-generation product candidate, Entolasta, pursuant to which, in March 2025, we exercised our option to acquire an exclusive worldwide license to the neutropenia indication for Entolimod. Entolimod and Entolasta have been the subject of more than forty animal and human trials and $140 million of prior investment, including $35.6 million from the Department of Defense, Defense Threats Reduction Agency, NASA, National Institutes of Health and the Department of Army. The FDA has granted Fast Track designation to Entolimod for the prevention and treatment of ARS and to mitigate the likelihood of death following a potential lethal dose of total body ionization during or after a radiation disaster.
Current report
Our immediate focus with Entolimod will be validation of the manufacturing process, including first lot manufacturing and bioequivalency testing sufficient to submit a biologics license application (“BLA”) to the FDA. A BLA is a submission to the FDA requesting to market a biologic product in the United States. The FDA uses the information and testing results presented in the BLA to ensure that biologic processes meet rigorous safety, purity and potency standards. If the BLA is approved, the FDA will issue us a biologics license, at which point we may begin marketing of the biologic compound in the United States. Prior to such approval, we may have opportunities to market Entolimod for emergency use in markets outside of the United States. In addition, we have an active IND application for oncology-related applications and intend to use it to initiate a phase 2 clinical study for Entolimod for the treatment of neutropenia.
Current report
We began utilizing the equity line of credit in May 2025 and, as of June 30, 2025, we have sold an aggregate of 87,558 shares of our common stock to Mast Hill for gross proceeds of $332 thousand and net proceeds of $311 thousand, after deducting offering costs.
Current report
On June 18, 2025, we entered into an Amended and Restated Exclusive License Agreement (the “A&R License Agreement”) with Statera, which amended certain terms of the License Agreement to, amongst other things, (i) provide that the payment of royalties pursuant to the A&R License Agreement, if any, may be made by the Company in either cash or securities of the Company, at the discretion of the Company; (ii) increase the approximate amount of the lien held by Avenue Venture Opportunities Fund, L.P. (“Avenue”) to up to $5.6 Million (the “Payoff Amount”); and (iii) provide that, other than the original license fee paid by the Company to Statera in connection with the closing of the license transaction in February 2025 and payment of the Neutropenia Milestone Payment, until such date that the Payoff Amount has been paid in full to Avenue, all subsequent payments due to Statera under the A&R License Agreement shall be paid by the Company as follows: 20% of any such payments shall be paid to Statera and 80% of any such payments shall be paid directly to Avenue on behalf of Statera.
Current report
In connection with the Preferred Purchase Agreement, we also entered into a registration rights agreement with the Investor, pursuant to which we agreed to file with the SEC a registration statement covering the Conversion Shares and the Warrant Shares so as to permit the resale of such securities by the Investor. On June 6, 2025, we filed a registration statement publicly with the SEC to register for resale the Conversion Shares and Warrant Shares underlying the securities issued to the Investor in the initial Tranche, which we amended on July 25, 2025, and on July 30, 2025, the registration statement was declared effective by the SEC. Additionally, on August 8, 2025, we filed a registration statement publicly with the SEC to register for resale the Conversion Shares and Warrant Shares underlying the securities issued to the Investor in the second Tranche, which was declared effective by the SEC on August 12, 2025.
Current report
In connection with closing of the initial Tranche, we paid Craft $56,000 and issued warrants to purchase an aggregate of 10,000 shares of our common stock to the designees of Craft, which warrants have a term of four years from the date of issuance, are exercisable immediately upon issuance, and have an exercise price of $4.20 per share of common stock (equal to 110% of the closing price per share of the Company’s common stock on June 25, 2025). Additionally, in connection with closing of the second Tranche, we paid Craft $56,000 and we issued warrants to purchase an aggregate of 11,068 shares of our common stock to the designees of Craft, which warrants have a term of four years from the date of issuance, are exercisable immediately upon issuance, and have an exercise price of $3.795 per share of common stock (equal to 110% of the closing price per share of the Company’s common stock on July 31, 2025).
Current report
Blake Gurfein stepped down as our Chief Scientific Officer and transitioned to a consulting role. We also continued to build and invest in developing our intellectual property portfolio.
Current report
We expect revenues to decrease as we plan to reduce our spending on the significant costs of advertising and marketing required to support sales of ClearUP. We will continue to consider alternative ways to monetize ClearUP and expect to complete a strategic transaction or otherwise exit the consumer business by the end of the year. Our near-term focus is to advance the development of our biopharmaceutical candidates and to ultimately achieve revenue through the sale of Entolimod.
Current report
For the six months ended June 30, 2025, cost of sales decreased by $225 thousand, or 82%, compared to the same period in 2024. The decrease was due to a 69% decrease in unit sales, a reduction in overhead costs of $35 thousand and inventory write-offs of $35 thousand in 2024 which did not recur in 2025. Variable cost was $45 thousand, or $54.73 per unit, for the six months ended June 30, 2025, compared to $205 thousand, or $78.95 per unit, for the same period in 2024. The decrease in variable costs is due to restructuring of our supply chain with new partners completed in August 2024 and certain inventory adjustments, including scrap write-offs, that occurred in 2024. Fixed costs were $7 thousand, or $8.70 per unit, for the six months ended June 30, 2025, compared to $72 thousand, or $27.90 per unit, for the same period in 2024. The decrease in the fixed costs was due to lower product support and overhead costs.
Current report
For the three months ended June 30, 2025, research and development expenses increased by $353 thousand compared to the same period in 2024. For the six months ended June 30, 2025, research and development expenses increased by $432 thousand compared to the same period in 2024. The increases for both periods were primarily due to the addition of our biopharma program that was formed when we acquired the exclusive worldwide license to the patented TLR5 agonist, Entolimod, from Statera. The increased costs are comprised primarily of employment related expenses, consulting expenses and manufacturing and validation services.
Current report
Sales and marketing expenses increased to $426 thousand for the three months ended June 30, 2025, compared to $207 thousand for the three months ended June 30, 2024. The increase was primarily related to the addition of business development headcount and consultants related to Entolimod. The increase was offset by a 59% reduction in advertising spend as we focused our capital resources into advancing our TLR5 program.
Current report
Sales and marketing expenses decreased to $605 thousand for the six months ended June 30, 2025, compared to $712 thousand for the six months ended June 30, 2024. The decrease was due primarily to a $257 thousand reduction in advertising and other marketing costs related to ClearUP, offset by $117 thousand of increased expenses related to Entolimod business development activities. The decrease in advertising and other marketing costs was driven by our decision to focus our capital resources into advancing our TLR5 program.
Current report
For the six months ended June 30, 2025, general and administrative expenses increased by $275 thousand compared to the same period in 2024. The overall increase was the result of increases in employee related costs of $113 thousand, including stock-based compensation increases of $85 thousand, increased legal and professional fees of $125 thousand, and increased corporate expenses of $202 thousand related primarily to the Nasdaq hearing and additional shareholder meeting held in 2025. The increases were offset by a decrease of $153 thousand in lease and office expenses due to the change in our headquarters in the second quarter of 2024.
Current report
Hill pursuant to the Mast Hill Purchase Agreement for gross proceeds of $215 thousand and net proceeds of $204 thousand after deducting offering costs.
Current report
Our financing activities provided $2.4 million of cash during the six months ended June 30, 2025. In February 2025, Series A warrants to purchase 7,524 shares of common stock were exercised for proceeds of $109 thousand. In April 2025, we sold an aggregate of 172,700 shares of common stock pursuant to our Equity Distribution Agreement with Maxim for gross proceeds of $1.8 million and net proceeds of $1.6 million after deducting commissions and offering expenses. In May 2025, we sold an aggregate of 87,558 shares of our common stock to Mast Hill pursuant to the equity line of credit for gross proceeds of $332 thousand and net proceeds of $311 thousand after deducting offering costs. In June 2025, we sold and issued to the Investor a total of 700 shares of Series B Preferred Stock and warrants to purchase 61,287 shares of our common stock, for gross proceeds of $700 thousand and net proceeds of $585 thousand after deducting placement agent fees and offering costs.
Current report
For the six months ended June 30, 2024, our financing activities provided $3.3 million of cash, which consisted primarily of proceeds from the sale of 4,710,000 shares of our common stock and Series A and Series B Warrants to purchase an aggregate of 11,775,000 shares of common stock in May 2024, net of offering discounts and other costs.
Current report
Lease costs recorded during the six months ended June 30, 2024 were $84 thousand. There were no lease costs recorded for the six months ended June 30, 2025 as the lease was terminated in 2024.
Current report
Statera A&R License Agreement
Removed paragraphs (28)
Previous report
Tivic's VNS program includes two complementary systems. Tivic’s first commercial system 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 with FDA approval as ClearUP Sinus Pain Relief for the treatment of sinus pain and congestion.
Previous report
A 2023 study with over 2,000 representative consumers conducted by Intellego Insights (commissioned by Tivic Health) identified that approximately 85 million U.S. adults experience inflammation-related symptoms related to allergies, congestion, head pain, and sinus issues. Of the consumers that participated in the study, 58% of sufferers try to avoid medication, if at all possible.
Previous report
VNS Clinical Research
Previous report
VNS Commercial Strategy
Previous report
Nasdaq Compliance
Previous report
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 are not currently in compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market, as set forth in Nasdaq Marketplace Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). On December 27, 2024, the Company received an additional letter from Nasdaq stating that it had not regained compliance with the Minimum Bid Price Requirement and was not eligible for a second 180-day remediation period, and that, unless it timely requested a hearing before a Hearings Panel (the “Panel”), the Company’s securities would be subject to suspension/delisting. After a hearing in front of the Panel, on March 6, 2025, the Company received a letter from the Panel granting its request for continued listing on the Nasdaq Capital Market, provided that the Company implemented a reverse stock split of its common stock on March 7, 2025 and demonstrated compliance with all such continued listing requirements for the Nasdaq Capital Market as of March 20, 2025.
Previous report
On April 4, 2025, the Company received a letter from Nasdaq confirming that the Company has regained compliance with the Minimum Bid Price Requirement, as required by the Panel’s decision dated March 6, 2025. As a result, the Company’s common stock will continue to be listed on the Nasdaq Capital Market.
Previous report
Reverse Stock Split - 2025
Previous report
Effective March 7, 2025, we implemented a reverse stock split of our issued and outstanding shares of common stock, par value $0.0001 per share, at a ratio of 1-for-17. As a result of the reverse stock split, the total number of shares of common stock held by each stockholder of the Company were converted automatically into the number of shares of common stock equal to the number of issued and outstanding shares of common stock held by each such stockholder immediately prior to the reverse stock split divided by 17. We issued one whole share of the post reverse stock split common stock to any stockholder who otherwise would have been entitled to receive a fractional share as a result of the reverse stock split (for a total of 76 shares). As a result, no fractional shares were issued in connection with the reverse stock split and no cash or other consideration was 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 dividing the number of shares of common stock into which such options, warrants and other convertible securities were exercisable or convertible by 17 and multiplying the exercise or conversion price thereof by 17, 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. There was no change to the par value, or authorized shares, of either the common stock or preferred stock, as a result of the reverse stock split.
Previous report
All share and per share amounts for our common stock, as well as the number of shares of common stock issuable upon conversion of outstanding preferred stock and upon exercise of options and warrants outstanding, and exercise prices thereof, from dates prior to completion of the reverse stock split that are included in this Quarterly Report, including the financial statements and footnotes thereto included herein, have been retroactively restated to give effect to the reverse stock split.
Previous report
Each share of Series A Preferred Stock is convertible into approximately 588 shares of common stock, as described below. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series A Preferred Stock are set forth in the Certificate of Designation (as defined and described below).
Previous report
In connection with the Purchase Agreement, the Company and the Investor also entered into a registration rights agreement, pursuant to which the Company agreed to file with the Commission, no later than fifteen (15) days from the execution sate, a registration statement (the “Registration Statement”) covering the Conversion Shares and the Warrant Shares (collectively, the “Preferred Offering Registrable Securities”) so as to permit the resale of such securities by the Investor. The Company shall use commercially reasonable efforts to keep the registration statement effective, including but not limited to pursuant to Rule 415 promulgated under the Securities Act, and available for the resale by the Investor of all of the Preferred Offering Registrable Securities covered thereby at all times until the date on which the Investor shall have sold all the Preferred Offering Registrable Securities or they cease to require registration pursuant to the registration rights agreement.
Previous report
Designation of Series B Preferred Stock
Previous report
On April 29, 2025, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series B Non-Voting Convertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of Delaware in connection with the Preferred Offering. The Certificate of Designation became effective upon filing and designates 8,400 shares of the Company’s preferred stock as Series B Non-Voting Convertible Preferred Stock, par value $0.0001 per share.
Previous report
Ranking. The Series B Preferred ranks senior to the Company’s common stock and Series A Preferred stock with respect to dividend rights and rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company.
Previous report
Dividends. The holders of outstanding shares of Series B Preferred shall be entitled to cumulative dividends at an annual rate of 10% of the Stated Value (as defined below) per share. Dividends shall accrue from the date of each such Tranche Closing, and for as long as any shares of Series B Preferred remain issued and outstanding and are payable quarterly in arrears. At the Company’s option, dividends on the Series B Preferred may be paid in (i) cash, (ii) by adding the amount of dividends payable on such date to the aggregate Stated Value of such Holder’s shares of Series B Preferred Stock (“PIK Dividends”), or (iii) any combination of cash and PIK Dividends. The “Stated Value” shall mean $1,000 per share, subject to adjustment in the event of any stock dividend (including PIK Dividends), stock split, combination, recapitalization, or other similar event affecting such shares.
Previous report
Voting. Except as otherwise provided by the Certificate of Designation or required by law, the Series B Preferred does not have voting rights. However, as long as any shares of Series B Preferred are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series B Preferred, (i) alter or change adversely the powers, preferences or rights given to the Series B Preferred or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Company’s amended and restated certificate of incorporation, as amended (the “Charter”), or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series B Preferred, (ii) issue further shares of Series B Preferred, or (iii) enter into any agreement with respect to any of the foregoing.
Previous report
Conversion. Subject to certain beneficial ownership limitations and, until such date that Stockholder Approval is obtained, the Exchange Cap, at any time after the issuance date, each holder of Series B Preferred shall have the right, at such holder’s option, to convert any or all of the shares of Series B Preferred held by such holder into fully paid and nonassessable shares of Company common stock. The number of shares of common stock issuable upon conversion of each share of Series B Preferred shall be equal to the quotient obtained by dividing (i) the Stated Value of such share of Series B Preferred plus all accrued and unpaid dividends thereon by (ii) the Conversion Price (as defined below) in effect on the date of conversion. The conversion price (the “Conversion Price”) in effect on any conversion date shall be equal to 90% of the lowest closing volume-weighted average price of the Company’s common stock on the Nasdaq Capital Market for the five trading days immediately preceding the date of the conversion notice delivered by the holder, subject to adjustment, provide, however, that in no event shall the Conversion Price be lower than $1.294 per share (the “Floor Price”), subject to adjustment.
Previous report
Liquidation. In the event of any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary, the holders of Series B Preferred shall be entitled to receive, prior and in preference to any distribution of any of the assets, funds, or proceeds available for distribution of the Company to the holders of Common Stock or any other class or series of capital stock ranking junior to the Series B Preferred upon liquidation, by reason of their ownership thereof, an amount per share equal to the greater of (i) the Stated Value plus all accrued and unpaid dividends thereon or (ii) the amount that such Holder would receive if such Holder converted all of its shares of Series B Preferred into common stock immediately prior to such liquidation, dissolution or winding up.
Previous report
Redemption. The Company may, at any time and in its sole discretion, request to redeem all or any portion of the outstanding shares of Series B Preferred at a price equal to 115% of the Stated Value plus all accrued and unpaid dividends thereon by providing the holder at least 10 days prior written notice, during which 10 day period the holder thereof shall have the right to convert such holder’s shares of Series B Preferred into shares of Company common stock. Upon the closing of any equity or equity-linked financing by the Company after the issuance date, the holder shall have the right, but not the obligation, to require the Company to redeem, out of the proceeds of such financing, up to 25% of the aggregate amount of net proceeds raised in the financing, outstanding shares of Series B Preferred at a per share price equal to the Stated Value plus all accrued and unpaid dividends thereon, provided that such right shall expire 5 days after the holder receives notice from the Company of the consumption of a financing.
Previous report
Scorpius Statement of Work
Previous report
We expect continued variability in sales as we manage advertising spend and seek alternative ways to monetize ClearUP.
Previous report
For the three months ended March 31, 2025, research and development expenses increased by $79 thousand compared to the same period in 2024. The increase was primarily due to additional headcount-related costs.
Previous report
Sales and marketing expenses decreased to $179 thousand for the three months ended March 31, 2025, compared to $505 thousand for the three months ended March 31, 2024. The decrease was due to a 92% reduction in advertising spend as we we focused our capital resources into securing the Statera Licensing Agreement.
Previous report
On February 13, 2023, we completed the sale of 11,765 shares of our common stock in a firm commitment, fully underwritten registered public offering, resulting in net proceeds to the Company of approximately $3.6 million. From July 11, 2023 to August 9, 2023, we sold an aggregate of 68,779 shares of our common stock to certain investors in a series of registered public offerings, resulting in aggregate net proceeds to the Company of approximately $4.3 million. Additionally, in May 2024, we sold an aggregate of 277,059 shares of our common stock, together with Series A warrants to purchase an aggregate of 277,059 shares of common stock and Series B warrants to purchase an aggregate of 415,589 shares of common stock, to certain investors in a registered public offering, resulting in net proceeds to the company of approximately $3.3 million.
Previous report
Our financing activities provided $82 thousand of cash during the three months ended March 31, 2025, which consisted primarily of proceeds from the exercise of 7,524 common warrants with proceeds of $109 thousand. For the three months ended March 31, 2024, our financing activities used $61 thousand of cash, which consisted of offering costs paid in advance of the sale of common stock.
Previous report
Lease costs recorded during the three month periods ended March 31, 2025 and 2024 were zero and $51 thousand, respectively.
Previous report
Statera License Agreement
Reworded paragraphs (69)
Previous wording
The following discussion and analysis of our financial condition and results of operations should be read together with the interim condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10‑Q (this "Quarterly Report"), as well as our audited financial statements and related notes as disclosed in our Annual Report on Form 10‑K for the fiscal year ended December 31, 2024. This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under Part II, Item 1A “Risk Factors” or in other parts of this Quarterly Report on Form 10‑Q, as well as those identified in the “Risk Factors” section of our Annual Report on Form 10‑K for the fiscal year ended December 31, 2024, each of which Risk Factors are incorporated in this Quarterly Report on Form 10-Q by reference. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. See “Forward-Looking Statements.”
Current wording
The following discussion and analysis of our financial condition and results of operations should be read together with the interim condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10‑Q (this“Quarterly Report”), as well as our audited financial statements and related notes as disclosed in our Annual Report on Form 10‑K for the fiscal year ended December 31, 2024 (our “Annual Report”). This discussion contains forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under Part II, Item 1A “Risk Factors” or in other parts of this Quarterly Report, as well as those identified in the “Risk Factors” section of our Annual Report, which Risk Factors are incorporated in this Quarterly Report by reference. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. See “Forward-Looking Statements.”
Previous wording
Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health’s bioelectronic program is developing non-invasive medical devices to meaningfully improve treatment options in neurologic, cardiac and autonomic-related diseases. Tivic Health currently offers a bioelectronic, FDA-approved over-the-counter device (ClearUP™) that treats sinus pain, pressure and congestion. ClearUP is available through online retailers and commercial distributors and at tivichealth.com. Tivic Health is further developing its bioelectronic portfolio with a focus on non-invasive vagus nerve stimulation.
Current wording
Tivic Health is a diversified immunotherapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health’s bioelectronic program is developing non-invasive medical devices to meaningfully improve treatment options in neurologic, cardiac and autonomic-related diseases. Tivic Health currently offers a bioelectronic, FDA-approved over-the-counter device (ClearUP®) that treats sinus pain, pressure and congestion. ClearUP is available through online retailers and commercial distributors and at tivichealth.com. Tivic Health’s bioelectronic portfolio today is primarily focused on non-invasive vagus nerve stimulation (“VNS”).
Previous wording
Tivic Health’s TLR5 program focuses on immunotherapeutics about to activate underactive immune systems. The lead product candidate is the late-stage TLR5 agonist, Entolimod™, to treat acute radiation syndrome ("ARS"). The U.S. Federal Drug Administration (“FDA”) has granted Fast Track and Orphan Drug designation to Entolimod™ for the treatment of ARS. Tivic Health is also preparing to file an investigational new drug ("IND") application and to initiate a phase 2 clinical study for Entolimod™ for the treatment of neutropenia.
Current wording
Tivic Health’s Toll-like Receptor 5 (“TLR5”) program focuses on immunotherapeutics that stimulate an underactive immune system. The lead product candidate is the late-stage TLR5 agonist, Entolimod™, to treat acute radiation syndrome (“ARS”). The U.S. Federal Drug Administration (“FDA”) has granted Fast Track designation to Entolimod™ for the treatment of ARS. Tivic Health has an investigational new drug (“IND”) application for oncology applications and plans to initiate a phase 2 clinical study for Entolimod™ for the treatment of neutropenia.
Previous wording
The second is a clincal-stage system directed to non-invasive vagus nerve stimulation.
Current wording
Tivic’s VNS program is advancing a clinical-stage system directed to non-invasive vagus nerve stimulation.
Previous wording
Tivic Health currently markets one commercial product under the brand name “ClearUP Sinus Pain Relief.” ClearUP is built on our patented, handheld neuromodulation design and was developed by Tivic Health for the treatment of sinus and allergy-related conditions. It uses ultra-low current electrical waves to relieve sinus pain and congestion symptoms that are prevalent in nasal allergies, sinus infections, chronic sinusitus, cold and flu as part of sinonasal immune responses. ClearUP has been approved by the U.S. Federal Drug Administration (“FDA”) for the indications of temporary relief of sinus pain associated with allergic rhinitis and temporary relief of congestion. ClearUP is the first FDA-approved bioelectronic treatment of the foregoing indications.
Current wording
Tivic Health currently markets one commercial product under the brand name “ClearUP Sinus Pain Relief.” ClearUP is built on our patented, handheld neuromodulation design and was developed by Tivic Health for the treatment of sinus and allergy-related conditions. It uses ultra-low current electrical waves to relieve sinus pain and congestion symptoms that are prevalent in nasal allergies, sinus infections, chronic sinusitus, cold and flu as part of sinonasal immune responses. ClearUP has been approved by the FDA for the indications of temporary relief of sinus pain associated with allergic rhinitis and temporary relief of congestion. ClearUP is the first FDA-approved bioelectronic treatment of the foregoing indications.
Previous wording
Based upon these encouraging results, in May 2024, we initiated a second collaborative research study with Feinstein to identify VNS device parameters, including frequency, signal parameters, electrode placement and duration of treatment, that deliver the optimal effect on autonomic nervous system (“ANS”) function (elsewhere referred to as our "optimization study"). In September 2024, we announced approval for the contracted clinical work by Northwell Health's Institutional Review Board, required before enrollment of subjects. In October 2024, we announced enrollment of the first subject in this optimization study for our patent pending, non-invasive vagus nerve stimulation device. The results will be used to inform clinical indication priority and commercial development. Enrollment was completed in November 2024. In early 2025, following the completion of two rounds of study visits, the Company expanded the protocol to include additional parameters for optimization, leading to additional intellectual property, including those claims covered in various patent filings.
Current wording
Based upon these encouraging results, in May 2024, we initiated a second collaborative research study with Feinstein to identify VNS device parameters, including frequency, signal parameters, electrode placement and duration of treatment, that deliver the optimal effect on autonomic nervous system (“ANS”) function (elsewhere referred to as our “optimization study”). In September 2024, we announced approval for the contracted clinical work by Northwell Health’s Institutional Review Board, required before enrollment of subjects. In October 2024, we announced enrollment of the first subject in this optimization study for our patent pending, non-invasive VNS device. Enrollment was completed in November 2024. In early 2025, following the completion of two rounds of study visits, the Company expanded the protocol to include additional parameters for optimization, leading to additional intellectual property, including those claims covered in various patent filings. In June 2025, the Company announced the completion of the optimization study, noting that findings reinforce the importance of personalization for therapeutic efficacy. The results of the study are expected to be released later this year, following patent filings, and will be used to inform clinical indication priority and commercial development.
Previous wording
In September 2024, we announced our partnership with Fletcher Spaght, Inc ("FSI"), a leading healthcare growth strategy firm, to accelerate development of our commercial strategy for ncVNS. The firm has completed a comprehensive market assessment of our ncVNS technology drawing from outcomes from our clinical study results. FSI initially identified approximately 30 potential medical use cases for our ncVNS technology in neurologic, cardiac, psychiatric and autonomic nervous system diseases. Working closely with Tivic’s scientific and clinical leadership, the firm has identified a set of prioritized target indications with the strongest potential for market entry, based on market research, clinical reviews and interviews with key opinion leaders and payers.
Current wording
In September 2024, we announced our partnership with Fletcher Spaght, Inc (“FSI”), a leading healthcare growth strategy firm, to accelerate development of our commercial strategy for ncVNS. The firm has completed a comprehensive market assessment of our ncVNS technology drawing from outcomes from our clinical study results. FSI initially identified approximately 30 potential medical use cases for our ncVNS technology in neurologic, cardiac, psychiatric and autonomic nervous system diseases. Working closely with our scientific and clinical leadership, FSI has identified a set of prioritized target indications with the strongest potential for market entry, based on market research, clinical reviews and interviews with key opinion leaders and payers.
Previous wording
Craft Capital Management LLC acted as our placement agent in connection with this transaction. As compensation for such services, we will pay Maxim a commission of 3.0% of the aggregate gross proceeds from each sale of Put Shares under the Mast Hill Purchase Agreement.
Current wording
Craft Capital Management LLC (“Craft”) acted as our placement agent in connection with this transaction. As compensation for such services, we will pay Craft a commission of 3.0% of the aggregate gross proceeds from each sale of Put Shares under the Mast Hill Purchase Agreement.
Previous wording
In connection with the Mast Hill Purchase Agreement, the Company and Mast Hill also entered into a registration rights agreement, pursuant to which we agreed to file with the Commission an initial registration statement covering (i) all of the Put Shares issuable under the Mast Hill Purchase Agreement the Commitment Shares (collectively, the “Mast Hill Registrable Securities”) so as to permit the resale of such securities by Mast Hill. On May 2, 2025, we filed the registration statement with the SEC confidentially, and, after receiving notice from the SEC that they would not be reviewing it, we filed the registration statement publicly on May 9, 2025. The registration statement was declared effective by the SEC on March 13, 2025. Pursuant to the registration rights agreement, we shall keep the registration statement effective, including but not limited to pursuant to Rule 415 promulgated under the Securities Act and available for the resale by Mast Hill of all of the Mast Hill Registrable Securities covered thereby at all times until the date on which Mast Hill shall have sold all the Mast Hill Registrable Securities and the Maximum Commitment Amount has been drawn down by the Company.
Current wording
In connection with the Mast Hill Purchase Agreement, the Company and Mast Hill also entered into a registration rights agreement, pursuant to which we agreed to file with the SEC an initial registration statement covering all of the Put Shares issuable under the Mast Hill Purchase Agreement and the Commitment Shares so as to permit the resale of such securities by Mast Hill. On May 9, 2025, we filed the registration statement publicly with the SEC, and on March 13, 2025, the registration statement was declared effective by the SEC.
Previous wording
On February 11, 2025, we entered into the License Agreement with Statera, whereby we acquired (i) an exclusive worldwide license to the patented TLR5 agonist lead program of Statera known as Entolimod (the “Licensed Molecules”) as it relates to the ARS indication (the “Initial Indication”) and (ii) an exclusive option (the “Exclusive Option”) to acquire the exclusive worldwide license to additional indications, including Lymphocyte Exhaustion, Immunosenescence, Neutropenia and/or Vaccine Adjuvant (the “Subsequent Indications”) and to the TLR5 agonist follow-on program of Statera known as Entolasta, in each case as described in more detail below. The License Agreement transaction was consummated concurrently therewith on February 11, 2025 (the “Closing Date”).
Current wording
On February 11, 2025, we entered into an exclusive license agreement with Statera (the “License Agreement”), pursuant to which we acquired (i) an exclusive worldwide license to the patented TLR5 agonist lead program of Statera known as Entolimod (the “Licensed Molecules”) as it relates to the ARS indication (the “Initial Indication”) and (ii) an exclusive option (the “Exclusive Option”) to acquire the exclusive worldwide license to additional indications, including Lymphocyte Exhaustion, Immunosenescence, Neutropenia and/or Vaccine Adjuvant (the “Subsequent Indications”) and to the TLR5 agonist follow-on program of Statera known as Entolasta, in each case as described in more detail below. The License Agreement transaction was consummated concurrently therewith on February 11, 2025 (the “Closing Date”).
Previous wording
Under the terms of the License Agreement, Statera has granted the Company an exclusive worldwide license, with the right to grant and authorize sublicenses, under Statera’s patents, trademarks, know-how and other intellectual property to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit the product Entolimod as it relates to the Initial Indication during the term of the License Agreement.
Current wording
Under the terms of the License Agreement, Statera granted the Company an exclusive worldwide license, with the right to grant and authorize sublicenses, under Statera’s patents, trademarks, know-how and other intellectual property to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit the product Entolimod as it relates to the Initial Indication during the term of the License Agreement.
Previous wording
As consideration for the License Agreement, we agreed to pay Statera a license fee of $1,500,000 consisting of (i) $300,000 in cash consideration and (ii) $1,200,000 in stock consideration, as described below. The Company remains liable to Statera for certain royalty payments on net sales for the ARS indication as a single agent, and, if it exercises the Exclusive Option, net sales for all Subsequent Indications, within certain royalty periods.
Current wording
As consideration for the License Agreement, we agreed to pay Statera a license fee of $1,500,000 consisting of (i) $300,000 in cash consideration and (ii) $1,200,000 in stock consideration, as described below. As additional consideration for the License Agreement, the Company agreed to pay Statera certain royalty payments on net sales for the ARS indication as a single agent, and, if it exercises the Exclusive Option with respect to any Subsequent Indication, net sales for such Subsequent Indications, within certain royalty periods.
Previous wording
Upon exercise of an Exclusive Option with respect to one or more Subsequent Indications, the following corresponding applicable milestones and milestone payments, payable in in either the cash or Company stock (at our sole discretion), become obligations of the Company as well:
Current wording
Upon exercise of an Exclusive Option with respect to one or more Subsequent Indications, the following corresponding applicable milestones and milestone payments (all milestone payments, collectively, the “Milestone Payments”), payable in in either the cash or Company stock (at our sole discretion), become obligations of the Company as well:
Previous wording
On March 28, 2025, the Company notified Statera of its election to exercise its Exclusive Option to acquire the exclusive worldwide license to the neutropenia indication for Entolimod under the License Agreement (the “Neutropenia Option”) and to accelerate the first milestone payment of $500,000 related to the neutropenia indication, payable by the Company in connection with the filing of an IND and initiation of a Phase 2 clinical study for neutropenia. The payment of $500 thousand was paid in Company stock, as discussed in additional detail below.
Current wording
On March 28, 2025, we notified Statera of our election to exercise our Exclusive Option to acquire the exclusive worldwide license to the neutropenia indication for Entolimod under the License Agreement (the “Neutropenia Option”) and to accelerate the first milestone payment of $500,000 related to the neutropenia indication (the “Neutropenia Milestone Payment”), payable by the Company in connection with the filing of an IND and initiation of a Phase 2 clinical study for neutropenia. We paid the $500 thousand Neutropenia Milestone Payment in Company stock, as discussed in additional detail below.
Previous wording
As a result of the Company’s exercise of the Neutropenia Option, the Company is obligated to develop and commercialize the expanded licensed products related to the neutropenia indication, at its own cost and expense, including to meet those milestones discussed above, and is obligated to pay the milestone payments, other than the Neutropenia Option, upon accomplishing each such milestone.
Current wording
As a result of our exercise of the Neutropenia Option, we are obligated to develop and commercialize the expanded licensed products related to the neutropenia indication, at our own cost and expense, including to meet those milestones discussed above, and are obligated to pay the milestone payments, other than the Neutropenia Option, upon accomplishing each such milestone.
Previous wording
In conjunction with the License Agreement, Statera may nominate one individual to sit on Board. Statera’s nominee must have the relevant industry experience in biopharmaceuticals, meet all requirements for service as an Independent Board Member, as defined by Nasdaq listing requirements. Approval of such Statera nominee shall be at the sole reasonable discretion of the Board.
Current wording
Pursuant to the License Agreement, Statera may nominate one individual to sit on our Board of Directors (the “Board”). Statera’s nominee must have the relevant industry experience in biopharmaceuticals, meet all requirements for service as an Independent Board Member, as defined by Nasdaq listing requirements. Approval of such Statera nominee shall be at the sole reasonable discretion of the Board.
Previous wording
Pursuant to the License Agreement, we agreed to hold a stockholders’ meeting within 120 days of the Closing Date to submit the approval of the conversion of shares of the Company's Series A Non-Voting Convertible Preferred Stock ("Series A Preferred Stock") into shares of Company common stock in accordance with the rules of the Nasdaq Stock Market LLC (the “Conversion Proposal”) to its stockholders for their consideration, provided, however that Statera agreed to extend the deadline to hold the stockholders' meeting to June 30, 2025. In connection therewith, we have agreed to file a proxy statement on Schedule 14A with the SEC. If the requisite stockholder approval is not obtained within the time period referenced above, then we shall convene additional stockholder meetings every 90 days thereafter until the requisite stockholder approval is obtained.
Current wording
Additionally, pursuant to the License Agreement, we agreed to hold a stockholders’ meeting within 120 days of the Closing Date to submit the approval of the conversion of shares of our Series A Non-Voting Convertible Preferred Stock (“Series A Preferred Stock”) into shares of Company common stock to our stockholders for their consideration, in accordance with the rules of the Nasdaq Stock Market LLC, provided, however that Statera agreed to extend the deadline to hold the stockholders’ meeting to June 30, 2025. Stockholder approval was obtained at our annual shareholder meeting on June 30, 2025.
Previous wording
On February 11, 2025, in connection with and as consideration for the License Agreement, the Company entered into a Securities Purchase Agreement with Statera, pursuant to which the Company issue and sold to Statera an aggregate of (i) 55,635 shares of Company common stock and (ii) approximately 360 shares of Series A Preferred Stock for an aggregate price of approximately $1.2 million.
Current wording
On February 11, 2025, in connection with and as consideration for the License Agreement, we entered into a Securities Purchase Agreement with Statera, pursuant to which we issued to Statera an aggregate of (i) 55,635 shares of Company common stock and (ii) approximately 360 shares of Series A Preferred Stock for an aggregate price of approximately $1.2 million.
Previous wording
On March 31, 2025, in connection with the Company's exercise of the Neutropenia Option pursuant to the License Agreement and as consideration for the exercise of its option to accelerate the first milestone payment of $500 thousand related to the neutropenia indication, and pursuant to a Securities Purchase Agreement entered into as of the same date, the Company issued $500 thousand shares of Company stock, consisting of an aggregate of 55,704 shares of common stock and approximately 131 shares of Series A Preferred Stock.
Current wording
On March 31, 2025, in connection with our election to exercise the Neutropenia Optionand to accelerate payment of the Neutropenia Milestone Payment, we entered into a Securities Purchase Agreement with Statera and Avenue, pursuant to which we issued to Statera and Avenue $500 thousand shares of Company stock, consisting of an aggregate of 55,704 shares of common stock and approximately 131 shares of Series A Preferred Stock.
Previous wording
The Securities Purchase Agreements also provide the recipients of shares of the Series A Preferred Stock and common stock (together, the "Securities") with registration rights related to the Securities. Specifically, the Company is required to prepare and file a resale registration statement with the Commission within 60 calendar days following the closing date, with respect to the common stock and the shares of common stock underlying the Series A Preferred Stock.
Current wording
The Securities Purchase Agreements also provide the recipients of shares of the Series A Preferred Stock and common stock with registration rights related to the shares of common stock underlying the shares of Series A Preferred issued to such recipients.
Previous wording
On April 29, 2025, the Company entered into an Securities Purchase Agreement (the “Preferred Purchase Agreement”) with an investor (the “Investor”), pursuant to which, subject to the conditions set forth therein, the Company shall sell to the Investor, and the Investor shall purchase from the Company, up to 8,400 shares of the Company’s newly designated Series B Non-Voting Convertible Preferred Stock (“Series B Preferred”) and warrants (“Warrants”) to purchase shares of the Company’s common stock for a total purchase price of up to $8,400,000 (the “Preferred Offering”) in several tranche closings (each, a “Tranche Closing”).
Current wording
On April 29, 2025, we entered into an Securities Purchase Agreement (the “Preferred Purchase Agreement”) with an investor (the “Investor”), pursuant to which, subject to the conditions set forth therein, we shall sell to the Investor, and the Investor shall purchase from us, up to 8,400 shares of our Series B Non-Voting Convertible Preferred Stock (“Series B Preferred Stock”) and warrants (“Warrants”) to purchase shares of Company common stock for a total purchase price of up to $8,400,000 (the “Tranched Financing”) in several tranche closings (each, a “Tranche Closing”).
Previous wording
The Preferred Purchase Agreement provides that the Preferred Offering shall be conducted through six separate Tranche Closings pursuant to which, subject to satisfaction of the applicable closing conditions set forth in the Preferred Purchase Agreement, the Company shall sell and issue the Investor up to an aggregate of 8,400 shares of Series B Preferred as follows: (i) 700 shares of Series B Preferred, for $700,000, in the initial Tranche Closing, which shall be consummated upon effectiveness of the Registration Statement (defined below); (ii) 700 shares of Series B Preferred, for $700,000, in the second Tranche Closing, which shall be consummated 10 trading days after the initial Tranche Closing; (iii) 1,750 shares of Series B Preferred, for $1,750,000, in the third Tranche Closing, which shall be consummated 20 trading days after the second Tranche Closing; (iv) 1,750 shares of Series B Preferred, for $1,750,000, in the fourth Tranche Closing, which shall be consummated 20 trading days after the third Tranche Closing; (v) 1,750 shares of Series B Preferred, for $1,750,000, in the fifth Tranche Closing, which shall be consummated 20 trading days after the fourth Tranche Closing; and (vi) 1,750 shares of Series B Preferred, for $1,750,000, in the final Tranche Closing, which shall be consummated 20 trading days after the fifth Tranche Closing.
Current wording
The Preferred Purchase Agreement provides that the Tranched Financing shall be conducted through six separate Tranche Closings, pursuant to which, subject to satisfaction of the applicable closing conditions set forth in the Preferred Purchase Agreement, we shall sell and issue the Investor up to an aggregate of 8,400 shares of Series B Preferred Stock as follows: (i) 700 shares of Series B Preferred Stock, for $700,000, in the initial Tranche Closing, which occurred on June 25, 2025; (ii) 700 shares of Series B Preferred Stock, for $700,000, in the second Tranche Closing, which occurred on July 31, 2025; (iii) 1,750 shares of Series B Preferred Stock, for $1,750,000, in the third Tranche Closing, which shall be consummated 20 trading days after the second Tranche Closing; (iv) 1,750 shares of Series B Preferred Stock, for $1,750,000, in the fourth Tranche Closing, which shall be consummated 20 trading days after the third Tranche Closing; (v) 1,750 shares of Series B Preferred Stock, for $1,750,000, in the fifth Tranche Closing, which shall be consummated 20 trading days after the fourth Tranche Closing; and (vi) 1,750 shares of Series B Preferred Stock, for $1,750,000, in the final Tranche Closing, which shall be consummated 20 trading days after the fifth Tranche Closing.
Previous wording
In addition to the shares of Series B Preferred to be sold and issued to the Investor in the Preferred Offering, at each Tranche Closing the Company shall also issue the Investor a Warrant to purchase that number of shares of Company common stock equal to 30% of shares of common stock issuable upon conversion in full of the shares of Series B Preferred issued at the same Tranche Closing. Each Warrant shall be immediately exercisable (subject to certain beneficial ownership limitations and Stockholder Approval), expire five years from the date of issuance, and have an initial exercise price equal to the average closing price of the Company’s common stock during the prior five trading days preceding each Tranche Closing (as may be adjusted for stock dividends, subdivisions, or combinations in the manner described in the Warrant). In the event that Warrants issued to the Investor in a subsequent Tranche Closing have a lower exercise price than the Investor’s Warrants outstanding as of such later Tranche Closing, immediately after the Tranche Closing the exercise price of all outstanding Warrants held by the Investor shall automatically be reduced to equal such lower exercise price of the Warrants issued in such Tranche Closing.
Current wording
In addition to the shares of Series B Preferred Stock to be sold and issued to the Investor in the Tranched Financing, at each Tranche Closing we shall also issue the Investor a Warrant to purchase that number of shares of Company common stock equal to 30% of shares of common stock issuable upon conversion in full of the shares of Series B Preferred Stock issued at the same Tranche Closing. Each Warrant shall be immediately exercisable (subject to certain beneficial ownership limitations), expire five years from the date of issuance, and have an initial exercise price equal to the average closing price of the Company’s common stock during the prior five trading days preceding each Tranche Closing (as may be adjusted for stock dividends, subdivisions, or combinations in the manner described in the Warrant). In the event that Warrants issued to the Investor in a subsequent Tranche Closing have a lower exercise price than the Investor’s Warrants outstanding as of such later Tranche Closing, immediately after the Tranche Closing the exercise price of all outstanding Warrants held by the Investor shall automatically be reduced to equal such lower exercise price of the Warrants issued in such Tranche Closing.
Previous wording
In the event that the average closing price of the Company’s common stock during the prior three trading days preceding a Tranche Closing date shall not be equal to or greater than the Floor Price (as defined below), then the applicable Tranche Closing shall be delayed until such time as the price meets the required threshold for a period of five consecutive trading days. Notwithstanding the foregoing, the Investor has the ability, subject to prior written consent of the Company, to purchase any number of shares of Series B Preferred prior to the dates of the Tranche Closings provided for in the Preferred Purchase Agreement.
Current wording
In the event that the average closing price of the Company’s common stock during the prior three trading days preceding a Tranche Closing date shall not be equal to or greater than the Floor Price (as defined below), then the applicable Tranche Closing shall be delayed until such time as the price meets the required threshold for a period of five consecutive trading days. Notwithstanding the foregoing, the Investor has the ability, subject to prior written consent of the Company, to purchase any number of shares of Series B Preferred Stock prior to the dates of the Tranche Closings provided for in the Preferred Purchase Agreement.
Previous wording
Pursuant to the Preferred Purchase Agreement, subject to certain exceptions, for so long as any shares of Series B Preferred remain outstanding (the “ROFR Period”), the Investor will have a right of first refusal to with respect to any investment proposed to be made by any other person for each and every future variable rate transaction during the ROFR Period. Additionally, subject to certain exceptions, for so long as any the Investor holds any shares of Series B Preferred, Warrants, shares of common stock issued upon conversion of shares of Series B Preferred (“Conversion Shares”) or shares of common stock issued upon exercise of the Warrants (“Warrant Shares,” and collectively with the Series B Preferred, Warrants and Conversion Shares, the “Securities”), the Investor shall have the right to participate in any subsequent financing for up to 20% of such financing. Moreover, for so long as any shares of Series B Preferred remain outstanding, subject to certain exceptions, the Investor shall have the right to require the Company to use 25% of the proceeds received by the Company from any future financing to redeem any shares of Series B Preferred held by the Investor in accordance with the terms of the Series B Preferred Certificate of Designation.
Current wording
Pursuant to the Preferred Purchase Agreement, subject to certain exceptions, for so long as any shares of Series B Preferred Stock remain outstanding (the “ROFR Period”), the Investor will have a right of first refusal to with respect to any investment proposed to be made by any other person for each and every future variable rate transaction during the ROFR Period. Additionally, subject to certain exceptions, for so long as any the Investor holds any shares of Series B Preferred Stock, Warrants, shares of common stock issued upon conversion of shares of Series B Preferred Stock (“Conversion Shares”) or shares of common stock issued upon exercise of the Warrants (“Warrant Shares”), the Investor shall have the right to participate in any subsequent financing for up to 20% of such financing. Moreover, for so long as any shares of Series B Preferred Stock remain outstanding, subject to certain exceptions, the Investor shall have the right to require us to use 25% of the proceeds received by us from any future financing to redeem any shares of Series B Preferred Stock held by the Investor.
Previous wording
The consummation of the transactions contemplated by the Preferred Purchase Agreement is subject to various customary closing conditions. In addition, pursuant to the Preferred Purchase Agreement, unless and until the Company obtains stockholder approval to issue additional shares in accordance with applicable Nasdaq Rules (“Stockholder Approval”), the Investor is prohibited from converting its shares of Series B Preferred and exercising its Warrants to the extent that such conversions and exercises would, in the aggregate, result in the issuance of shares of common stock exceeding 19.99% of the number of shares of Company common stock issued and outstanding on the execution date (the “Exchange Cap”). The Investor shall have no obligation to fund the second or subsequent Tranche Closings unless and until Stockholder Approval has been obtained, and the Company has agreed to file a proxy statement on Schedule 14A with the Securities and Exchange Commission (the “Commission”) to obtain Stockholder Approval no later than twenty (20) days from the execution date.
Current wording
The consummation of the transactions contemplated by the Preferred Purchase Agreement is subject to various customary closing conditions. In addition, pursuant to the Preferred Purchase Agreement, unless and until we obtained stockholder approval to issue additional shares in accordance with applicable Nasdaq Rules (“Stockholder Approval”), the Investor was prohibited from converting its shares of Series B Preferred Stock and exercising its Warrants to the extent that such conversions and exercises would, in the aggregate, result in the issuance of shares of common stock exceeding 19.99% of the number of shares of Company common stock issued and outstanding on the execution date. Stockholder Approval was obtained at our annual shareholder meeting on June 30, 2025.
Previous wording
The Purchase Agreement and registration rights agreement contain customary representations, warranties and agreements, as well as customary indemnification obligations of the Company.
Current wording
The Preferred Purchase Agreement and registration rights agreement contain customary representations, warranties and agreements, as well as customary indemnification obligations of the Company.
Previous wording
Craft acted as placement agent to the Company in connection with the Preferred Offering. As consideration for services rendered by Craft, the Company shall pay Craft a cash fee equal to eight percent (8%) of any such funds received by the Company from the Investor pursuant to the Preferred Purchase Agreement.
Current wording
Craft acted as placement agent to the Company in connection with the Tranched Financing. As consideration for services rendered by Craft, we shall (i) pay Craft a cash fee equal to eight percent (8%) of any such funds received by us from the Selling Stockholder pursuant to the Preferred Purchase Agreement and (ii) issue to Craft that number of warrants to purchase shares of our common stock equal in value to six percent (6%) of any such funds received by us from the Investor pursuant to the Preferred Purchase Agreement.
Previous wording
On May 9, 2025, the Company entered into a Statement of Work (the “Scorpius SOW”) with Scorpius BioManufacturing, Inc. (“Scorpius”), pursuant to which Scorpius will serve as the primary U.S. manufacturer for the Company’s late-stage TLR5 agonist, Entolimod, for the treatment of acute radiation syndrome. Pursuant to the Scorpius SOW, Scorpius will provide the following services, among others: cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and upstream and downstream optimization of the process. The Scorpius SOW shall be governed by the Terms and Conditions attached thereto, unless and until a Master Services Agreement is executed by and between the parties in connection with the services contemplated by the Scorpius SOW.
Current wording
On May 9, 2025, we entered into a Statement of Work (the “Scorpius SOW”) with Scorpius BioManufacturing, Inc. (“Scorpius”), pursuant to which Scorpius will serve as the primary U.S. manufacturer for our late-stage TLR5 agonist, Entolimod, for the treatment of acute radiation syndrome. Pursuant to the Scorpius SOW, Scorpius will provide the following services, among others: cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and upstream and downstream optimization of the process. The Scorpius SOW shall be governed by the Terms and Conditions attached thereto, unless and until a Master Services Agreement is executed by and between the parties in connection with the services contemplated by the Scorpius SOW.
Previous wording
Pursuant to the Scorpius SOW, the Company has agreed to pay Scorpius service fees estimated to be approximately $2.4 million, with a total estimated investment by the Company of approximately $4.1 million, inclusive of additional pass-through costs and expenses, including for consumables and external services. The fees and costs will be payable on a milestone-based invoicing schedule tied to the completion of defined project stages and deliverables, as provided in the Scorpius SOW. Pass-through costs for raw materials, consumables, reagents, shipping, and subcontracted services will be managed by Scorpius on behalf of the Company at cost plus a 15% administrative fee. The Company is required to settle invoices within 30 days, with Scorpius reserving the right to impose monthly interest charges of 1% for undisputed amounts unpaid after 30 days. The Company will also be responsible for payment of any taxes, fees, duties or charges imposed by any governmental authority in connection with the services provided by Scorpius under the Scorpius SOW, other than on Scorpius’ net income taxes or franchise taxes.
Current wording
Pursuant to the Scorpius SOW, we have agreed to pay Scorpius service fees estimated to be approximately $2.4 million, with a total estimated investment by the Company of approximately $4.1 million, inclusive of additional pass-through costs and expenses, including for consumables and external services. The fees and costs will be payable on a milestone-based invoicing schedule tied to the completion of defined project stages and deliverables, as provided in the Scorpius SOW. Pass-through costs for raw materials, consumables, reagents, shipping, and subcontracted services will be managed by Scorpius on behalf of the Company at cost plus a 15% administrative fee. We are required to settle invoices within 30 days, with Scorpius reserving the right to impose monthly interest charges of 1% for undisputed amounts unpaid after 30 days. We will also be responsible for payment of any taxes, fees, duties or charges imposed by any governmental authority in connection with the services provided by Scorpius under the Scorpius SOW, other than on Scorpius’ net income taxes or franchise taxes.
Previous wording
The Scorpius SOW includes detailed project management provisions, including the assignment of a dedicated project manager, regular project team meetings, risk management procedures, and the use of a project-dedicated site for document sharing and collaboration. The Company will own all deliverables provided by Scorpius, and intellectual property provisions specify that any foreground intellectual property generated specifically in connection with the development or manufacture of Entolimod (other than improvements to Scorpius background intellectual property and foreground intellectual property that is related primarily to the business of Scorpius generally conducted for its client) will be solely and exclusively owned by the Company. Additionally, Scorpius is required to provide monthly updates to the Company to keep it informed of progress and results of the activities in the scope of the Scorpius SOW.
Current wording
The Scorpius SOW includes detailed project management provisions, including the assignment of a dedicated project manager, regular project team meetings, risk management procedures, and the use of a project-dedicated site for document sharing and collaboration. The Company will own all deliverables provided by Scorpius, and intellectual property provisions specify that any foreground intellectual property generated specifically in connection with the development or manufacture of Entolimod (other than improvements to Scorpius background intellectual property and foreground intellectual property that is related primarily to the business of Scorpius generally conducted for its client) will be solely and exclusively owned by the Company. Additionally, Scorpius is required to provide monthly updates to us to keep it informed of progress and results of the activities in the scope of the Scorpius SOW.
Previous wording
Either party to the Scorpius SOW has the right to terminate the Scorpius SOW (i) upon written sixty (60) days’ written notice to other party for any reason or (ii) upon breach of a material provision of the Scorpius SOW and failure to cure within thirty (30) days’ written notice. In connection with any termination, the Company is required to pay (i) any open invoices and (ii) the documented reasonable expense incurred or irrevocably obligated related to the Scorpius SOW and Scorpius to wind down activities, plus as liquidated damages and not as a penalty, an amount equal to the greater of a 50% of the cost of the Scorpius SOW not yet performed or (b) 75% of the prices of the services for the applicable manufacturing run(s) set to be performed within sixty (60) days of termination under the Scorpius SOW.
Current wording
Either party to the Scorpius SOW has the right to terminate the Scorpius SOW (i) upon written sixty (60) days’ written notice to other party for any reason or (ii) upon breach of a material provision of the Scorpius SOW and failure to cure within thirty (30) days’ written notice. In connection with any termination, we are required to pay (i) any open invoices and (ii) the documented reasonable expense incurred or irrevocably obligated related to the Scorpius SOW and Scorpius to wind down activities, plus as liquidated damages and not as a penalty, an amount equal to the greater of (a) 50% of the cost of the Scorpius SOW not yet performed or (b) 75% of the prices of the services for the applicable manufacturing run(s) set to be performed within sixty (60) days of termination under the Scorpius SOW.
Previous wording
In the first three months of 2025 we hired Michael Handley, previous Chief Executive Officer, President and Chairman of Statera Biopharma as Chief Operating Officer of Tivic and President, Tivic Biopharma, a role in which he will lead the establishment of a biopharmaceutical capability within Tivic. We also continued to build and invest in developing our intellectual property portfolio.
Current wording
In February 2025, we hired Michael Handley, the previous Chief Executive Officer, President and Chairman of Statera, as Chief Operating Officer of Tivic and President, Tivic Biopharma, a role in which he will lead the establishment of a biopharmaceutical capability within Tivic. In July 2025, our Board appointed Lisa Wolf as our permanent Chief Financial Officer. Ms. Wolf previously served as our interim Chief Financial Officer since October 2024 and has been supporting Tivic as a consultant since 2022. In July 2025,
Previous wording
Comparison of the Three Months Ended March 31, 2025 and 2024
Current wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Previous wording
For the three months ended March 31, 2025, revenue decreased overall by $264 thousand, or 79%, compared to the same period in 2024, primarily due to a 81% decrease in the number of units sold associated with a 92% decrease in advertising spend as we focused our capital resources into securing the Statera Licensing Agreement.
Current wording
For the six months ended June 30, 2025, revenue decreased overall by $318 thousand, or 67%, compared to the same period in 2024, primarily due to a 69% decrease in the number of units sold associated with a 60% decrease in advertising spend as we focused our capital resources into securing the License Agreement with Statera and accelerating our TLR5 program.
Previous wording
For the three months ended March 31, 2025, cost of sales decreased by $147 thousand, or 88%, compared to the same period in 2024, primarily driven by the decrease in unit sales. Variable cost was $16 thousand, or $45.38 per unit, for the three months ended March 31, 2025, compared to $129 thousand, or $72.21 per unit, for the same period in 2024. The decrease in variable costs is due to restructuring of our supply chain with new partners completed in August 2024 and certain inventory adjustments, including scrap write-offs, that occurred in 2024. Fixed costs were $4 thousand, or $12.76 per unit, for the three months ended March 31, 2025, compared to $38 thousand, or $21.04 per unit, for the same period in 2024. The decrease in the fixed cost was primarily due to lower product support costs.
Current wording
For the three months ended June 30, 2025, cost of sales decreased by $78 thousand, or 71%, compared to the same period in 2024. The decrease was due to the decrease in unit sales, a reduction in overhead costs of $17 thousand and inventory write-offs of $20 thousand in 2024 which did not recur in 2025. Variable cost was $29 thousand, or $61.41 per unit, for the three months ended June 30, 2025, compared to $55 thousand, or $68.86 per unit, excluding the $20 thousand inventory write-off, for the same period in 2024. The decrease in variable costs is due to restructuring of our supply chain with new partners completed in August 2024 and certain inventory adjustments, including scrap write-offs, that occurred in 2024. Fixed costs were $3 thousand, or $5.80 per unit, for the three months ended June 30, 2025, compared to $35 thousand, or $43.25 per unit, for the same period in 2024. The decrease in the fixed cost was primarily due to lower product support and overhead costs.
Previous wording
Gross margin has been and will continue to be affected by, and is likely to fluctuate on a quarterly basis due to, a variety of factors, including sales volumes, product and channel mix, pricing strategies, costs of finished goods, and product return rates, new product launches and potential new manufacturing partners and suppliers. We expect our gross margin to improve with optimization of our product design and supply-chain, and increasing sales volume over which fixed and semi-fixed costs are allocated.
Current wording
Gross margin has been and will continue to be affected by, and is likely to fluctuate on a quarterly basis due to, a variety of factors, including sales volumes, product and channel mix, pricing strategies, costs of finished goods, and product return rates, new product launches and potential new manufacturing partners and suppliers.
Previous wording
During the three months ended March 31, 2025, our gross margin has increased by 21% compared to the same period in 2024. The increase is due to the restructuring of our supply chain and move to a lower cost logistics provider.
Current wording
During the three months ended June 30, 2025, our gross margin increased by 41% compared to the same period in 2024. During the six months ended June 30, 2025, our gross margin increased by 25% compared to the same period in 2024. The increases were due to the restructuring of our supply chain and move to a lower cost logistics provider.
Previous wording
Sales and marketing expenses include personnel costs and expenses for advertising and other marketing services. Personnel costs consist of salaries, bonuses, benefits and stock-based compensation expense. We expect sales and marketing expenses to vary as we continue to support our current markets and distribution channels..
Current wording
Sales and marketing expenses include personnel costs, consulting expenses and expenses for advertising and other marketing services. Personnel costs consist of salaries, bonuses, benefits and stock-based compensation expense. As of the second quarter of 2025, sales and marketing expenses include the costs associated with business development and government relations efforts related to Entolimod, in addition to advertising and other marketing costs related to our ClearUP product. We expect sales and marketing expenses to vary as we expand our selling efforts related to Entolimod.
Previous wording
For the three months ended March 31, 2025, general and administrative expenses increased by $155 thousand compared to the same period in 2024. The overall increase was the result of increases of $254 thousand in legal and other fees primarily related to our special shareholder meeting in January and our Nasdaq hearing in February, offset by decreases of $50 thousand in lease expenses due to the change in our headquarters in the second quarter of 2024 and decreases in other expenses.
Current wording
For the three months ended June 30, 2025, general and administrative expenses increased by $120 thousand compared to the same period in 2024. The overall increase was the result of increases in employee related costs of $132 thousand, including stock-based compensation increases of $65 thousand, and increased corporate expenses of $109 thousand related to the Nasdaq hearing and additional shareholder meeting held in 2025. The increases were offset by a decrease of $100 thousand in lease and office expenses due to the change in our headquarters in the second quarter of 2024.
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Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
Non-invasive Cervical Vagus Nerve Stimulation
Current report — wording carried from elsewhere
For the three months ended June 30, 2025, revenue decreased overall by $54 thousand, or 39%, compared to the same period in 2024, primarily due to a 41% decrease in the number of units sold associated with a 57% decrease in advertising spend as we focused our capital resources into accelerating our TLR5 program.
Current report — wording carried from elsewhere
As previously disclosed, we encountered disruptions in our supply of various materials and components in 2022 due to the well-documented shortages and constraints in the global supply chain. Although we currently do not anticipate a supply shortage, unforeseen shortages, including as a result of tariffs and/or trade wars, may continue to pose a material risk for the Company in the near term or future. Additionally, high levels of safety stock can (and did in Q4 2024) result in the Company holding significant reserves against future obsolescence. We continue to maintain significant amounts of inventory on hand relative to the ClearUP unit sales to-date in 2025. At this time, we do not have any plans to manufacture additional products related to ClearUP. If we are unable to sell the current inventory on hand, we are at risk of further inventory write-downs in 2025.
Current report — wording carried from elsewhere
Our entry into biologic therapeutics requires us to develop relationships with new suppliers, which may adversely impact our ability to accurately forecast lead times and manufacturing costs for our TLR5 Program. We intend to regularly evaluate alternative and secondary source suppliers in order to ensure that we are able to source sufficient materials to manufacture our product candidates. Global supply chain shortages (especially when coupled with the increase in tariffs, inflation and other economic factors) could result in an increase in the cost of materials needed for our product candidates. Additionally, in the event that we are unable to to develop relationships with suppliers or source sufficient materials from suppliers to manufacture enough of our product candidates to satisfy demand, we may have to cease or slow down production and our business operations and financial condition may be materially harmed and we may need to alter our plan of operation.
Current report — wording carried from elsewhere
On May 9, 2025, we entered into the Scorpius SOW with Scorpius, pursuant to which Scorpius will serve as the primary U.S. manufacturer for our late-stage TLR5 agonist, Entolimod, for the treatment of acute radiation syndrome. Pursuant to the Scorpius SOW, Scorpius will provide the following services, among others: cell line verification, legacy process verification, GMP scale-up production, drug product fill and finish, analytical development and qualification, and upstream and downstream optimization of the process.
Current report — wording carried from elsewhere
Pursuant to the Scorpius SOW, we have agreed to pay Scorpius service fees estimated to be approximately $2.4 million, with a total estimated investment by the Company of approximately $4.1 million, inclusive of additional pass-through costs and expenses, including for consumables and external services. The fees and costs will be payable on a milestone-based invoicing schedule tied to the completion of defined project stages and deliverables, as provided in the Scorpius SOW. Pass-through costs for raw materials, consumables, reagents, shipping, and subcontracted services will be managed by Scorpius on behalf of the Company at cost plus a 15% administrative fee. We are required to settle invoices within 30 days, with Scorpius reserving the right to impose monthly interest charges of 1% for undisputed amounts unpaid after 30 days. We will also be responsible for payment of any taxes, fees, duties or charges imposed by any governmental authority in connection with the services provided by Scorpius under the Scorpius SOW, other than on Scorpius’ net income taxes or franchise taxes. The Company estimates the duration of the Scorpius SOW to be approximately two years, with approximately $3.0 million of costs to be incurred in the next 12 months. As of June 30, 2025 we have paid Scorpius a total of $209 thousand in connection with the Scorpius SOW.