Tivic Health Systems, Inc.

Previous 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.

Current wording

Tivic Health’s Toll-like Receptor 5 (“TLR5”) program’s lead product candidate is the late-stage TLR5 agonist, Entolimod™, to treat acute radiation syndrome (“ARS”) and for remediating side effects of medical radiation and chemotherapy. Tivic Health holds investigational new drug (“IND”) applications for Entolimod for ARS and advanced cancer applications. The U.S. Federal Drug Administration (“FDA”) has granted Fast Track and Orphan Drug designations to Entolimod™ for the treatment of ARS. The Company has licensed the rights to Entolimod and Entolasta as they related to the neutropenia indication and plans, over time, to undertake Phase 2 clinical studies for Entolimod and/or Entolasta for the treatment of neutropenia and other oncology-related indications.

Previous wording

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 wording

As announced in February 2025, we acquired worldwide exclusive license rights from Statera Biopharma, Inc. (“Statera”) to the late-stage toll-like receptor 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. In March 2025, we exercised our option to acquire an exclusive worldwide license to the neutropenia indication for Entolimod and Entolasta. 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 and Orphan Drug designations 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.

Previous wording

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 wording

Our immediate focus with Entolimod will be validation of the manufacturing process 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.

Previous wording

In May 2024, we announced the final results of an initial clinical validation study with The Feinstein Institutes for Medical Research at Northwell Health (“Feinstein”). Through this collaboration, we have confirmed the effectiveness of our patent-pending non-invasive 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. The study had the following results:

Current wording

In May 2024, we announced the final results of an initial clinical validation study with The Feinstein Institutes for Medical Research at Northwell Health (“Feinstein”). Through this collaboration, we have confirmed the effectiveness of our patent-pending non-invasive 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.

Previous wording

The magnitude of our ncVNS data imply potential for greater clinical effects and enhanced reproducibility than demonstrated by previous studies of non-invasive VNS devices. These results in healthy subjects suggest our ncVNS approach may have clinical utility in several patient populations including those with post-traumatic stress disorder, cardiac disease, inflammatory conditions, and ischemic stroke, among others.

Current wording

The magnitude of change in biometrics seen in our ncVNS data implies potential for greater clinical effects and enhanced reproducibility than demonstrated by previous studies of non-invasive VNS devices. These results in healthy subjects suggest our ncVNS approach may have clinical utility in several patient populations including those with post-traumatic stress disorder, cardiac disease, inflammatory conditions, and ischemic stroke, among others.

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 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.

Current wording

Based upon initial 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, and in November 2025, the Company announced the filing of resulting intellectual property and reported study outcomes. While study outcomes have been positive, the company is currently focusing its resources on the advancement of its lead product candidate and investments in its bioelectronics program may be significantly reduced or eliminated.

Previous wording

On March 18, 2025, we entered into an Equity Purchase Agreement (the “Mast Hill Purchase Agreement”) with Mast Hill Fund, L.P. (“Mast Hill”), pursuant to which we will have the right, but not the obligation, to sell to Mast Hill, and Mast Hill will have the obligation to purchase from us, up to $25 million (the “Maximum Commitment Amount”) shares of our common stock (the “Put Shares”), at our sole discretion, over the next 24 months, subject to certain conditions precedent and other limitations.

Current wording

On March 18, 2025, we entered into an Equity Purchase Agreement (the “Mast Hill Purchase Agreement”) with Mast Hill Fund, L.P. (“Mast Hill”), pursuant to which we will have the right, but not the obligation, to sell to Mast Hill, and Mast Hill will have the obligation to purchase from us, up to $25 million shares of our common stock, at our sole discretion, over 24 months, subject to certain conditions precedent and other limitations. We began utilizing the equity line of credit in May 2025, and, as of September 30, 2025, we have sold an aggregate of 235,792 shares of our common stock to Mast Hill for gross proceeds of $783 thousand and net proceeds of $741 thousand, after deducting offering costs.

Previous 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”).

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 (“Investor Warrants”) to purchase shares of Company common stock for a total purchase price of up to $8,400,000 (the “Tranched Financing”) in a series of six separate tranche closings (each, a “Tranche Closing”). To date, we have completed a total of four of the six Tranche Closings for aggregate gross proceeds of $4.9 million and aggregate net proceeds of $4.3 million, after deducting placement agent fees and offering expenses paid by the Company.

Previous 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,

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 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, 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.

Previous wording

We have continued to intentionally maintain a small core team at this stage of the Company, including managing our headcount to reduce operating expenses. We have relied, and continue to rely, heavily on third-party service providers, including marketing agencies, contract manufacturing organizations, software-as-a-service platforms, clinical research organizations, academic research partnerships, finance and accounting support, quality and regulatory support and legal support to carry out our operations.

Current wording

We have continued to intentionally maintain a small core team at this stage of the Company, including managing our headcount to reduce operating expenses; however, as we progress in the clinical development of our product candidates, we expect that we will increase our headcount to address our needs. We have relied, and continue to rely, heavily on third-party service providers, including consultants, marketing agencies, contract manufacturing organizations, software-as-a-service platforms, clinical research organizations, academic research partnerships, finance and accounting support, quality and regulatory support and legal support to carry out our operations. As we integrate new services associated with the ramp-up in biologic development and commercialization, we may experience unexpected delays and incur additional expenses.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

Comparison of the Three and Nine Months Ended September 30, 2025*** and 2024***

Previous wording

Revenue is currently generated solely by the sale of our ClearUP and ancillary products, including accessories and accelerated shipping charges, and is net of return reserves. We currently sell ClearUP directly to consumers online through our own website and to resellers such as McKesson-affiliate Simply Medical, Cardinal Health and AmerisourceBergen. Through our online retailers, ClearUP is available through Amazon, McKesson, Optum Store, Walmart, Target, Best Buy, Cardinal Health and FSA/HSA Store.

Current wording

Revenue is currently generated solely by the sale of our ClearUP and ancillary products, including accessories and accelerated shipping charges, and is net of return reserves. We currently sell ClearUP directly to consumers online through our own website and to resellers such as McKesson-affiliate Simply Medical and Cardinal Health. Through our direct and reseller relationships, ClearUP has been available through Amazon, McKesson, Optum Store, Walmart, Target, Best Buy, Cardinal Health and FSA/HSA Store. We are in the process of winding down the consumer business and will no longer be selling ClearUP directly to consumers in 2026. Resellers who continue to hold inventory may continue to sell our product until their inventory is exhausted and we may fulfill orders by resellers until inventory is depleted.

Previous wording

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 wording

For the three months ended September 30, 2025, revenue increased overall by $20 thousand, or 16%, compared to the same period in 2024, primarily due to a 40% increase in the number of units sold offset by lower average selling prices as we reduced prices in order to increase unit sales and move through our existing inventory. Additionally, we reduced advertising spend in order to focus our capital resources into accelerating our TLR5 program.

Previous 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.

Current wording

For the nine months ended September 30, 2025, revenue decreased overall by $298 thousand, or 50%, compared to the same period in 2024, primarily due to a 45% decrease in the number of units sold associated with a 35% decrease in advertising spend as we focused our capital resources into securing the License Agreement with Statera and accelerating our TLR5 program.

Previous wording

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 wording

We expect revenues to decrease significantly as we plan to exit the consumer business by the end of the year. We are no longer spending the significant advertising and marketing costs required to support sales of ClearUP. Our near-term focus is to advance the development of our biopharmaceutical product candidates and to ultimately obtain regulatory approval of our product candidates and generate revenue through the sale thereof.

Previous wording

Cost of sales consists primarily of the materials and services to manufacture our products, the internal personnel costs to oversee manufacturing and supply chain functions, and the shipment of goods to customers. Cost of sales is expected to vary on an absolute basis as sales volume increases or decreases. Cost of sales also includes inventory adjustments and reserves which may be necessary due to excess or obsolete inventory. Cost of sales is expected to fluctuate as adjustments or additional reserves become necessary.

Current wording

Cost of sales consists primarily of the materials and services to manufacture our products, the internal personnel costs to oversee manufacturing and supply chain functions, and the shipment of goods to customers. Cost of sales is expected to vary on an absolute basis as sales volume increases or decreases. Cost of sales also includes inventory adjustments and reserves which may be necessary due to excess or obsolete inventory. Cost of sales is expected to decrease as we wind down and exit the consumer business.

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.

Current wording

Gross margin has been affected by a variety of factors, including sales volumes, product and channel mix, pricing strategies, costs of finished goods, and product return rates, and new manufacturing partners and suppliers.

Previous 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.

Current wording

During the three months ended September 30, 2025, our gross margin, without the $230 thousand of inventory reserves recorded, was 42%, compared to 35% for the same period in 2024. During the nine months ended September 30, 2025, our gross margin, without the $230 thousand of inventory reserves recorded, was 37% compared to 40% for the same period in 2024.

Previous wording

Research and development expenses consist primarily of costs incurred to conduct research, including the discovery, development and validation of product candidates. Research and development expenses include personnel costs, including stock-based compensation expense, third-party contractor services, including development and testing of prototype devices, and maintenance of limited in-house research facilities. We expense research and development costs as they are incurred. We expect research and development expenses to increase with the discovery and validation of new product candidates.

Current wording

Research and development expenses consist primarily of costs incurred to conduct research, including the discovery, development and validation of product candidates. Research and development expenses include personnel costs, including stock-based compensation expense, third-party contractor services, including cell line verification of Entolimod, development and testing of drug product, drug substance, and prototype devices, and maintenance of limited in-house research facilities. We expense research and development costs as they are incurred. We expect research and development expenses to increase as product candidates are advanced towards commercialization and with the discovery and validation of new product candidates.

Previous wording

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 wording

For the three months ended September 30, 2025, research and development expenses increased by $436 thousand compared to the same period in 2024. For the nine months ended September 30, 2025, research and development expenses increased by $868 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.

Previous 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.

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. Commencing in 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 have eliminated sales and marketing costs related to our ClearUP product and have expanded our business development efforts related to Entolimod.

Previous wording

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 wording

Sales and marketing expenses increased to $415 thousand for the three months ended September 30, 2025, compared to $234 thousand for the three months ended September 30, 2024. The increase was primarily related to the addition of business development headcount and consultants related to Entolimod as well as a modest increase in advertising expenses as we pushed to reduce inventory prior to our exit of the consumer business before year-end.

Previous wording

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 wording

Sales and marketing expenses increased to $1.0 million for the nine months ended September 30, 2025, compared to $0.9 million for the nine months ended September 30, 2024. The increase was due primarily to the addition of business development headcount and consultants related to Entolimod. The increase was offset by a $193 thousand reduction in advertising and other marketing costs related to ClearUP. The decrease in advertising and other marketing costs was driven by our decision to focus our capital resources into advancing our TLR5 program.

Previous wording

General and administrative expenses include D&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 audit services, and other consulting fees. We expect general and administrative expenses to remain relatively flat.

Current wording

General and administrative expenses include D&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 audit services, and other consulting fees. We expect general and administrative expenses to increase moderately as we implement compliance programs related to potential government customers.

Previous wording

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 wording

For the nine months ended September 30, 2025, general and administrative expenses increased by $521 thousand compared to the same period in 2024. The overall increase was the result of increases in employee related costs of $179 thousand, including stock-based compensation increases of $134 thousand, increased legal and professional fees of $228 thousand, and increased corporate expenses of $304 thousand which included increased investor relations expenses of $159 thousand, of which $93 thousand was non-cash expenses for warrants issued for services, and $109 thousand of expenses related to the Nasdaq hearing and additional shareholder meeting held in 2025. The increases were offset by a decrease of $145 thousand in lease expenses due to the change in our headquarters in the second quarter of 2024.

Previous wording

Since our formation in September 2016, we have devoted substantially all of our efforts to research and development, to regulatory clearance and to early market development and testing for our first product, released September 2019 in the United States, investments in product candidates deriving from our work in vagus nerve stimulation, entry into biologic therapeutics with our TLR5 program, and evaluation and conducting diligence on inorganic growth opportunities. Our focus has substantively shifted from growing the ClearUP business to advancing our biologic and bioelectronic pipeline towards commercial outcomes. We are not profitable and have incurred net losses and negative cash flows from our operations in each year since our inception. As of June 30, 2025, we had cash and cash equivalents of $1.2 million, working capital of $1.0 million and an accumulated deficit of $47.0 million. Subsequent to the end of the quarter, we received net proceeds of $0.6 million through the sale and issuance of shares of Series B Preferred Stock in the second Tranche Closing pursuant to the Preferred Purchase Agreement; and net proceeds of $200 thousand through the sale and issuance of shares of our common stock to Mast Hill pursuant to our equity line of credit.

Current wording

Since our formation in September 2016, we have devoted substantially all of our efforts to research and development, to regulatory clearance and to early market development and testing for our first product, released September 2019 in the United States, investments in product candidates deriving from our work in vagus nerve stimulation, entry into biologic therapeutics with our TLR5 program, and evaluation and conducting diligence on inorganic growth opportunities. Our focus has substantively shifted from growing the ClearUP business to advancing our biologic and bioelectronic pipeline towards commercial outcomes as we wind down the ClearUP business by the end of the year. We are not profitable and have incurred net losses and negative cash flows from our operations in each year since our inception. As of September 30, 2025, we had cash and cash equivalents of $3.5 million, working capital of $3.1 million and an accumulated deficit of $49.6 million.

Previous wording

On September 13, 2024, we entered into an Equity Distribution Agreement with Maxim Group LLC (“Maxim”), pursuant to which we may offer and sell, from time to time, through or to Maxim, as sales agent or principal, up to $10 million in shares of our common stock, subject to our then current “baby shelf” limitation under General Instruction I.B.6. of Form S-3. As of March 31, 2025, we had sold an aggregate of 193,161 shares of common stock pursuant to the Distribution Agreement, for gross proceeds of $1.2 million. We paid Maxim $37 thousand in commissions in connection with such sales. In the quarter ended June 30, 2025, we sold an aggregate of 172,700 shares of common stock pursuant to the agreement for gross proceeds of $1.8 million. We paid Maxim $53 thousand in commissions and $10 thousand in legal fee reimbursements. Net proceeds after deducting all offering costs were $1.6 million.

Current wording

On September 13, 2024, we entered into an Equity Distribution Agreement with Maxim Group LLC (“Maxim”), pursuant to which we may offer and sell, from time to time, through or to Maxim, as sales agent or principal, up to $10 million in shares of our common stock, subject to our then current “baby shelf” limitation under General Instruction I.B.6. of Form S-3. As of June 30, 2025, we had sold an aggregate of 3,456,435 shares of common stock pursuant to the Distribution Agreement, for gross proceeds of $3.0 million. We paid Maxim $90 thousand in commissions in connection with such sales. Net proceeds after deducting all offering costs were $2.8 million. No shares were sold pursuant to the Equity Distribution Agreement in the quarter ended September 30, 2025.

Previous wording

On March 18, 2025, we entered into the Mast Hill Purchase Agreement with Mast Hill, pursuant to which we will have the right, but not the obligation, to sell to Mast Hill up to $25 million in shares of our common stock from time to time over a two-year period, subject to certain conditions precedent and other limitations (including without limitation beneficial ownership limitations). As a condition to our ability to effect sales under the Mast Hill Purchase Agreement, the shares must be registered for resale by Mast Hill pursuant to an effective registration statement. As of June 30, 2025, we had sold an aggregate of 87,558 shares of our common stock to Mast Hill pursuant to the Mast Hill Purchase Agreement for gross proceeds of $332 thousand and net proceeds of $311 thousand after deducting offering costs. Subsequent to the end of the quarter, we have sold an aggregate of 63,845 additional shares of our common stock to Mast

Current wording

On March 18, 2025, we entered into the Mast Hill Purchase Agreement with Mast Hill, pursuant to which we will have the right, but not the obligation, to sell to Mast Hill up to $25 million in shares of our common stock from time to time over a two-year period, subject to certain conditions precedent and other limitations (including without limitation beneficial ownership limitations). As a condition to our ability to effect sales under the Mast Hill Purchase Agreement, the shares must be registered for resale by Mast Hill pursuant to an effective registration statement. As of September 30, 2025, we had sold an aggregate of 235,792 shares of our common stock to Mast Hill pursuant to the Mast Hill Purchase Agreement for gross proceeds of $783 thousand and net proceeds of $741 thousand after deducting placement agent fees and offering costs.

Previous wording

On April 29, 2025, we entered into the Preferred Purchase Agreement with 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 Series B Preferred Stock and Warrants for a total purchase price of up to $8.4 million in six separate Tranche Closings. The Investor's obligation to purchase shares of Series B Preferred Stock and Warrants and to complete a Tranche Closing is subject to satisfaction of certain conditions precedent and other limitations. On June 25, 2025, we closed the initial Tranche of funding, which included the sale and issuance to the Investor of 700 shares of Series B Preferred Stock and Warrants to purchase 61,287 shares of our common stock at an initial exercise price of $3.85 per share. Gross proceeds were $700 thousand and net proceeds were $585 thousand after deducting placement agent fees and offering expenses. Subsequent to the end of the quarter, we closed the second Tranche of funding, which included the sale and issuance to the Investor of 700 shares of Series B Preferred Stock and Warrants to purchase 64,065 shares of our common stock at an initial exercise price of $3.97 per share. Gross proceeds were $700 thousand and net proceeds were $635 thousand after deducting placement agent fees and offering expenses.

Current wording

On April 29, 2025, we entered into the Preferred Purchase Agreement with 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 Series B Preferred Stock and Investor Warrants for a total purchase price of up to $8.4 million in six separate Tranche Closings. The Investor's obligation to purchase shares of Series B Preferred Stock and Warrants and to complete a Tranche Closing is subject to satisfaction of certain conditions precedent and other limitations. On June 25, 2025, we closed the initial Tranche of funding, which included the sale and issuance to the Investor of 700 shares of Series B Preferred Stock and Investor Warrants to purchase 61,287 shares of our common stock at an initial exercise price of $3.85 per share. Gross proceeds were $700 thousand and net proceeds were $585 thousand, after deducting placement agent fees and offering expenses. On July 31, 2025, we closed the second Tranche of funding, which included the sale and issuance to the Investor of 700 shares of Series B Preferred Stock and Investor Warrants to purchase 64,065 shares of our common stock at an initial exercise price of $3.97 per share. Gross proceeds were $700 thousand and net proceeds were $635 thousand, after deducting placement agent fees and offering expenses. On August 21, 2025, we closed the third Tranche of funding, which included the sale and issuance to the Investor of 1,750 shares of Series B Preferred Stock and Investor Warrants to purchase 188,842 shares of our common stock at an initial exercise price of $3.372 per share. Gross proceeds were $1.75 million and net proceeds were $1.6 million, after deducting placement agent fees and offering expenses. On September 26, 2025, we closed the fourth Tranche of funding, which included the sale and issuance to the Investor of 1,750 shares of Series B Preferred Stock and Warrants to purchase 195,793 shares of our common stock at an initial exercise price of $3.04 per share. Gross proceeds were $1.75 million and net proceeds were $1.6 million, after deducting placement agent fees and offering expenses. Due to certain repricing protections in the Investor Warrants, the exercise price of the Investor Warrants issued in the initial, second and third tranche closings were adjusted down each time such warrants were subsequently issued to the investor at a lower price. Therefore, as of September 26, 2025, with the closing of the fourth Tranche, all warrants issued in connection with the Preferred Purchase Agreement had an exercise price of $3.04 per share.

Previous wording

Although we have taken measures to decrease our operating expenses, we expect that our operating expenses may increase significantly as we discover, acquire, validate and develop additional product candidates; seek regulatory approval and, if approved, proceed to commercialization of new products, including near-term investments in validation of our biologic manufacturing process, preparation of regulatory submissions to domestic and international bodies, and further activities supporting sales and commercialization of Entolimod and, in the future, Entolasta; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. Furthermore, we have incurred and will continue to incur additional costs associated with operating as a public company. Management expects to incur substantial additional operating losses for the foreseeable future to expand our markets, conduct pre-clinical and clinical trials, complete development or acquisition of new product lines, obtain regulatory approvals, launch and commercialize our products and continue research and development programs. Based on the Company’s current cash levels and burn rate, amongst other things, the Company believes its cash and financial resources may be insufficient to meet the Company’s anticipated needs for the twelve months following the date of issuance of the financial statements for the six months ended June 30, 2025, included elsewhere in this Quarterly Report, which raises substantial doubt about the Company’s ability to continue as a going concern within one year from the issuance date of the financial statements.

Current wording

Although we continuously monitor operating expenses, we expect that our operating expenses may increase significantly as we discover, acquire, validate and develop our current product candidates and new product candidates; seek regulatory approval and, if approved, proceed to commercialization of new products, including near-term investments in validation of our biologic manufacturing process, preparation of regulatory submissions to domestic and international bodies, and further activities supporting sales and commercialization of Entolimod and, in the future, Entolasta; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. Furthermore, we have incurred and will continue to incur additional costs associated with operating as a public company. Management expects to incur substantial additional operating losses for the foreseeable future to conduct pre-clinical and clinical trials, complete development or acquisition of new product lines, obtain regulatory approvals, launch and commercialize our products and continue research and development programs. Based on the Company’s current cash levels and burn rate, amongst other things, the Company believes its cash and financial resources may be insufficient to meet the Company’s anticipated needs for the twelve months following the date of issuance of the financial statements for the nine months ended September 30, 2025, included elsewhere in this Quarterly Report, which raises substantial doubt about the Company’s ability to continue as a going concern within one year from the issuance date of the financial statements.

Previous wording

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, our entry into biologic therapeutics through our Licence Agreement with Statera, evaluating and conducting diligence on potential licensing and acquisition candidates, and the establishment of public company operating infrastructure and general operations. Although we have taken measures to decrease our operating expenses, we expect that our operating expenses may increase as we advance our vagus nerve platform and biopharma program, as well as, over time, discover, acquire, validate or develop additional product candidates; seek regulatory approval and, if approved, proceed to commercialization of new products; obtain, maintain, protect and enforce our intellectual property portfolio; hire additional personnel; and maintain compliance with material government (in addition to environmental) regulations. We may increase our research and development investments in clinical studies to advance additional indications for Entolimod and Entolasta, as well as our vagus nerve platform during the remainder of 2025 and 2026. We also plan to increase investments in manufacturing and regulatory processes to advance the development of our licensed TLR5 agonist programs, known as Entolimod and Entolasta. Furthermore, we have incurred, and will continue to incur, costs associated with operating as a public company that we did not experience as a private 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, the regulatory approval process, 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 marketing approval and commercialize future product candidates, if at all. We expect to reduce our costs for advertising and marketing of ClearUP as we shift our capital resources to the advancement of our TLR5 agonist programs. As a result, we expect revenue to decline. Although we are considering alternative monetization strategies for ClearUP, there is no certainty that we will be successful in our efforts and may need to consider a complete strategic divestiture or other exit of the business. Additionally, clinical and preclinical development timelines, the probability of success, and costs can differ materially from expectations. We cannot forecast which product candidates may be best developed and/or monetized through future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Current wording

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, our entry into biologic therapeutics through our License Agreement with Statera, evaluating and conducting diligence on potential licensing and acquisition candidates, and the establishment of public company operating infrastructure and general operations. Although we have taken measures to manage our operating expenses, we expect that our operating expenses may increase as we advance product candidates, as well as, over time, discover, acquire, validate or develop additional product candidates; seek regulatory approval and, if approved, proceed to commercialization of new products; obtain, maintain, protect and enforce our intellectual property portfolio; hire additional personnel; and maintain compliance with material government (in addition to environmental) regulations. We may increase our research and development investments in clinical studies to advance additional indications for our licensed TLR5 agonists, Entolimod and Entolasta, during the remainder of 2025 and 2026. We also plan to increase investments in manufacturing and regulatory processes for these product candidates as we prepare to seek a Biologics License, via a BLA, from the FDA.

Previous wording

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 wording

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. The contract manufacturer that we engaged to manufacturer Entolimod has experienced financial stress in the wake of government actions earlier this year, which impacted several of its customers’ programs and negatively impacted its business and operating results. This has resulted in delays to our clinical development timeline, and may continue to result in further delays and/or additional costs in the event that they cease operations and/or if determine to engage an alternative contract manufacturer or manufacturers to replace them. We are continuing to monitor their situation and are considering our options. Foreseen or unforeseen supply chain shortages, including as a result of delays in the manufacturing of our product candidates, 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. As discussed elsewhere in this Quarterly Report, we do not intend to manufacture additional products related to ClearUP and we plan to wind down the consumer business before the end of year. During the third quarter of 2025, we recorded inventory reserves of $230 thousand for excess and obsolete inventory, which brings our total inventory balance to our expected net realizable value. Additionally, in the third quarter of 2025, we disposed of certain property and equipment related to ClearUP and recorded a net loss on the disposal of $117 thousand. We may incur additional costs related to the exit from the consumer business.

Previous wording

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 wording

We intend to regularly evaluate alternative and secondary manufacturing partners and source suppliers in order to ensure that we are able to support the manufacturing of our product candidates, including the development of processes, analytical methods and validation testing for the manufacturing process itself. Global supply chain concerns (including tariffs, inflation, trade policies, material lead times 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 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.

Previous wording

We have generated operating losses in each period since inception. We have incurred an accumulated deficit of $47.0 million through June 30, 2025. We expect to incur additional losses in the future as we expand both our research and development activities. Based on our current cash levels and burn rate, amongst other 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.

Current wording

We have generated operating losses in each period since inception. We have incurred an accumulated deficit of $49.6 million through September 30, 2025. We expect to incur additional losses in the future as we expand both our research and development activities. Based on our current cash levels and burn rate, amongst other 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.

Previous wording

Longer term, our ability to grow revenue will be dependent on our ability to successfully manufacture, secure regulatory approval for, and commercialize product candidates in our pipeline, including Entolimod, Entolasta and the product candidates stemming from our VNS program.

Current wording

Longer term, our ability to grow revenue will be dependent on our ability to successfully manufacture, secure regulatory approval for, and commercialize product candidates in our pipeline, including Entolimod, Entolasta and the product candidates stemming from our bioelectronic program.

Previous wording

Until such time, if ever, as we can generate substantial revenue from product sales, we expect to fund our operations and capital funding needs through equity and/or debt financings. We may also consider 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 result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items. If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.

Current wording

Until such time, if ever, as we can generate substantial revenue from product sales or licensing, we expect to fund our operations and capital funding needs through equity and/or debt financings. We may also consider 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 result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items. If we raise additional funds through governmental funding, collaborations, strategic partnerships and alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, reprioritize investments, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially and adversely affect our business, financial condition, results of operations and prospects.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2025 was $2.7 million, which consisted primarily of a net loss of $3.4 million, decreased by non-cash charges of $278 thousand and a net decrease of $439 thousand in our net operating assets and liabilities. The non-cash charges primarily consisted of $276 thousand of stock-based compensation. The change in our net operating assets and liabilities was primarily due to an increase in accounts payable and accrued expenses of $462 thousand and a decrease in prepaid expenses and other assets of $113 thousand.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2025 was $4.7 million, which consisted primarily of a net loss of $6.0 million, decreased by non-cash charges of $857 thousand and a net increase of $460 thousand in our net operating assets and liabilities. The non-cash charges primarily consisted of $415 thousand of stock-based compensation, $230 thousand of inventory reserves for excess and obsolete ClearUP inventory, a $117 thousand loss recorded on the disposal of property and equipment related to ClearUP, and $93 thousand of warrants issued to consultants for services. The change in our net operating assets and liabilities was primarily due to an increase in accounts payable and accrued expenses of $366 thousand.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024 was $3.0 million, which consisted primarily of a net loss of $2.7 million, decreased by non-cash charges of $190 thousand and increased by a net decrease of $396 thousand in our net operating assets and liabilities. The non-cash charges primarily consisted of stock-based compensation of $108 thousand and amortization of right-of-use assets of $76 thousand. The change in our net operating assets and liabilities was primarily due to a decrease in accounts payable and accrued expenses of $617 thousand, an increase in accounts receivable of $153 thousand, an increase in prepaid and other current assets of $139 thousand, and a decrease of $79 thousand in lease liabilities.

Current wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $4.4 million, which consisted primarily of a net loss of $4.2 million, decreased by non-cash charges of $266 thousand and increased by a net decrease of $448 thousand in our net operating assets and liabilities. The non-cash charges primarily consisted of stock-based compensation of $166 thousand and amortization of right-of-use assets of $76 thousand. The change in our net operating assets and liabilities was primarily due to a decrease in accounts payable and accrued expenses of $648 thousand, a decrease in accounts receivable of $160 thousand, a decrease in prepaid and other current assets of $93 thousand, and a decrease of $96 thousand in lease liabilities.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2025 was $546 thousand, which consisted primarily of $300 thousand of cash paid for the Statera License Agreement and transactions costs of $243 thousand. There were no investing activities for the six months ended June 30, 2024.

Current wording

Net cash used in investing activities for the nine months ended September 30, 2025 was $556 thousand, which consisted primarily of $300 thousand of cash paid for the Statera License Agreement and transactions costs of $243 thousand. There were no investing activities for the nine months ended September 30, 2024.

Previous wording

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 wording

Our financing activities provided $6.7 million of cash during the nine months ended September 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 2025, we sold an aggregate of 235,792 shares of our common stock to Mast Hill pursuant to the equity line of credit for gross proceeds of $783 thousand and net proceeds of $741 thousand after deducting offering costs. In the nine months ended September 30, 2025, we sold and issued to the Investor a total of 4,900 shares of Series B Preferred Stock and Investor Warrants to purchase an aggregate of 509,987 shares of our common stock, for gross proceeds of $4.9 million and net proceeds of $4.3 million after deducting placement agent fees and offering costs.