Q4 2025 Tivic Health Systems Inc Earnings Call

March 25, 2026

Speaker #1: Welcome to Tivic's conference call to discuss fiscal year and fourth quarter 2025 financial results. This call has been prerecorded. This call is being webcast, and the replay will be available on the IR section of the company's website for three months.

Speaker #1: Before we begin, please note that during today’s call, management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated in our forward-looking statements.

Speaker #1: Please read the safe harbor statement contained in the press release that Tivic Health issued today, as well as the risk factors contained in Tivic Health's filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025, which is expected to be filed with the SEC on March 31, 2026, as well as other company SEC filings.

Operator: Please read the safe harbor statement contained in the press release that Tivic Health issued today, as well as the risk factors contained in Tivic Health's filings with the SEC, including its annual report on Form 10-K for the year ended 31 December 2025, which is expected to be filed with the SEC on 31 March 2026, as well as other companies' SEC filings. On today's call, we have Tivic Health's Chief Executive Officer, Michael Handley, and Chief Financial Officer, Lisa Wolf. Now, let me turn the call over to Michael.

Speaker #1: On today's call, we have Tivic Health's Chief Executive Officer, Michael Handley, and Chief Financial Officer, Lisa Wolf. Now, let me turn the call over to Michael.

Speaker #2: Thank you, and welcome, everybody. It is a privilege to address you for the first time as CEO of Tivic. I'm honored to lead the company at this transformative juncture.

Michael K. Handley: Thank you, and welcome everybody. It is a privilege to address you for the first time as CEO of Tivic. I'm honored to lead the company at this transformative juncture. My focus is clear and resolute: evolving Tivic into a high-impact immunotherapy company dedicated to saving lives, advancing critical therapies to patients, and delivering significant long-term value to our shareholders. This year, 2025, was a defining year and a year of strategic transformation. We completed a fundamental pivot, transitioning into a focused immunotherapy biopharmaceutical company anchored by our Toll-like receptor 5 platform or TLR5. Our lead candidate, Entolimod, and its next generation successor, Entolasta, represent the future of this organization. Furthermore, we strategically acquired the capability to manufacture our own therapies in addition to creating a revenue stream for the company.

Michael Handley: Thank you, and welcome everybody. It is a privilege to address you for the first time as CEO of Tivic. I'm honored to lead the company at this transformative juncture. My focus is clear and resolute: evolving Tivic into a high-impact immunotherapy company dedicated to saving lives, advancing critical therapies to patients, and delivering significant long-term value to our shareholders. This year, 2025, was a defining year and a year of strategic transformation. We completed a fundamental pivot, transitioning into a focused immunotherapy biopharmaceutical company anchored by our Toll-like receptor 5 platform or TLR5. Our lead candidate, Entolimod, and its next generation successor, Entolasta, represent the future of this organization. Furthermore, we strategically acquired the capability to manufacture our own therapies in addition to creating a revenue stream for the company.

Speaker #2: My focus is clear and resolute: evolving Tivic into a high-impact immunotherapy company dedicated to saving lives, advancing critical therapies to patients, and delivering significant long-term value to our shareholders.

Speaker #2: This year, 2025, was a defining year and a year of strategic transformation. We completed a fundamental pivot transitioning into a focused immunotherapy biopharmaceutical company anchored by our toll-like receptor 5 platform, or TLR5.

Speaker #2: Our lead candidate in Tollimid, and its next-generation successor in Xelasta, represent the future of this organization. Furthermore, we strategically acquired the capability to manufacture our own therapies, in addition to creating a revenue stream for the company.

Speaker #2: Finally, we have made tremendous inroads to interested parties in the US government as well as allied international governments who are looking for a solution to protect their citizens from accidental or intentional radiation exposure.

Michael Handley: Finally, we have made tremendous inroads to interested parties in the US government as well as allied international governments who are looking for a solution to protect their citizens from accidental or intentional radiation exposure. To ensure we are the best possible stewards of your capital, we made the disciplined decision to discontinue the ClearUP device business and suspend our non-core neuromodulation programs. By shedding these legacy assets, we have concentrated 100% of our resources on high-value biotherapeutic opportunities. Now switching to our primary focus, the oncology supportive care market. This is a multi-billion dollar market, the oncology supportive care market. Approximately 60% of all cancer patients undergoing some form of radiation and/or chemotherapy could use this therapy that we have.

Michael K. Handley: Finally, we have made tremendous inroads to interested parties in the US government as well as allied international governments who are looking for a solution to protect their citizens from accidental or intentional radiation exposure. To ensure we are the best possible stewards of your capital, we made the disciplined decision to discontinue the ClearUP device business and suspend our non-core neuromodulation programs. By shedding these legacy assets, we have concentrated 100% of our resources on high-value biotherapeutic opportunities. Now switching to our primary focus, the oncology supportive care market. This is a multi-billion dollar market, the oncology supportive care market. Approximately 60% of all cancer patients undergoing some form of radiation and/or chemotherapy could use this therapy that we have.

Speaker #2: To ensure we are the best possible stewards of your capital, we made the disciplined decision to discontinue the clear-up device business and suspend our non-core neuromodulation programs.

Speaker #2: By shedding these legacy assets, we have concentrated 100% of our resources on high-value biotherapeutic opportunities. Now switching to our primary focus, the oncology supportive care market.

Speaker #2: This is a multibillion-dollar oncology supportive care market. Approximately 60% of all cancer patients undergoing some form of radiation and/or chemotherapy could use this therapy that we have.

Michael Handley: A large number of these patients suffer from debilitating or life-threatening side effects, including but not limited to myelosuppression, or the inability to make blood cells, gastrointestinal mucosal necrosis, or the destruction of GI tissue. Entolimod has the ability to mitigate these side effects and provide an improved quality of life, as well as potentially saving lives. The market is well established and is ripe for disruption by Entolimod, as it's the only known therapy that protects the bone marrow and the gastrointestinal tract from radiation and chemotherapy damage. It also can be used prophylactically in the clinical setting, thus having the ability to improve and save lives of those suffering from a cancer diagnosis and being treated with radiation or chemo.

Michael K. Handley: A large number of these patients suffer from debilitating or life-threatening side effects, including but not limited to myelosuppression, or the inability to make blood cells, gastrointestinal mucosal necrosis, or the destruction of GI tissue. Entolimod has the ability to mitigate these side effects and provide an improved quality of life, as well as potentially saving lives. The market is well established and is ripe for disruption by Entolimod, as it's the only known therapy that protects the bone marrow and the gastrointestinal tract from radiation and chemotherapy damage. It also can be used prophylactically in the clinical setting, thus having the ability to improve and save lives of those suffering from a cancer diagnosis and being treated with radiation or chemo.

Speaker #2: A large number of these patients suffer from debilitating, life-threatening side effects, including but not limited to myeloid suppression, or the inability to make blood cells, and gastrointestinal mucosal necrosis, or the destruction of GI tissue.

Speaker #2: Tollimid has the ability to mitigate these side effects and provide an improved quality of life, as well as potentially saving lives. The market is well established and is ripe for disruption by Tollimid, as it's the only known therapy that protects the bone marrow and the gastrointestinal tract from radiation and chemotherapy damage.

Speaker #2: It also can be used prophylactically in the clinical setting, thus having the ability to improve and save lives of those suffering from a cancer diagnosis and being treated with radiation or chemo.

Speaker #2: While the market for existing G-CSF drugs—the current drugs out there to treat neutropenia and other disease states associated with cancer, radiation, and chemo—is mature and faces pricing pressure from biosimilars, there is significant unmet need for next-generation protective agents.

Michael K. Handley: While the market for existing GCSF drugs, the current drugs out there to treat neutropenia and other disease states associated with cancer, radiation, and chemo, is mature and faces pricing pressure from biosimilars. There is significant unmet need for next-generation protective agents. Current treatments primarily responsible for bone marrow suppression after it occurs. Therapies that can prevent underlying tissue damage or offer a differential mechanism of action, such as our TLR5 agonist, which is Entolimod, target the high-value, non-commodity portion of this almost $15 billion market that is expected to grow up to $20 billion by the 2030s. Furthermore, Entolimod is also well-positioned to disrupt several established markets. This is due to its properties that activate signaling pathways that prevent programmed cell death in these vital tissues.

Michael Handley: While the market for existing GCSF drugs, the current drugs out there to treat neutropenia and other disease states associated with cancer, radiation, and chemo, is mature and faces pricing pressure from biosimilars. There is significant unmet need for next-generation protective agents. Current treatments primarily responsible for bone marrow suppression after it occurs. Therapies that can prevent underlying tissue damage or offer a differential mechanism of action, such as our TLR5 agonist, which is Entolimod, target the high-value, non-commodity portion of this almost $15 billion market that is expected to grow up to $20 billion by the 2030s. Furthermore, Entolimod is also well-positioned to disrupt several established markets. This is due to its properties that activate signaling pathways that prevent programmed cell death in these vital tissues.

Speaker #2: Current treatments primarily responsible for bone marrow suppression after it occurs; therapies that can prevent underlying tissue damage or offer a differential mechanism of action, such as our TLR5 agonists, which is in Tollimid, target the high-value non-commodity portion of this almost $15 billion market that is expected to grow over the $20 billion by the 2030s.

Speaker #2: Furthermore, in Tollimid, it is also well positioned to disrupt several established markets. This is due to its properties that activate signaling pathways that prevent programmed cell death in these vital tissues.

Speaker #2: We are aggressively moving Tollimid into large market clinical indications, beginning with neutropenia, or the lack of neutrophils, which is a type of white blood cell.

Michael Handley: We are aggressively moving Entolimod into large market clinical indications, beginning with neutropenia or the lack of neutrophils, which is a type of white blood cell. We are targeting to initiate physician-sponsored trials as early as this year to provide proof of efficacy and a basis to initiate our phase 2b studies in the future. There is a significant upside also in addition to these large, oncology markets. While we pursue these high-value commercial markets, while not being our core focus, we are additionally seeking upside in the biodefense sector. Entolimod is an ideal candidate for acute radiation syndrome. With over 15 years of development in FDA Fast Track and Orphan Drug Designation, it is uniquely positioned as a stockpiling agent for the Strategic National Stockpile.

Michael K. Handley: We are aggressively moving Entolimod into large market clinical indications, beginning with neutropenia or the lack of neutrophils, which is a type of white blood cell. We are targeting to initiate physician-sponsored trials as early as this year to provide proof of efficacy and a basis to initiate our phase 2b studies in the future. There is a significant upside also in addition to these large, oncology markets. While we pursue these high-value commercial markets, while not being our core focus, we are additionally seeking upside in the biodefense sector. Entolimod is an ideal candidate for acute radiation syndrome. With over 15 years of development in FDA Fast Track and Orphan Drug Designation, it is uniquely positioned as a stockpiling agent for the Strategic National Stockpile.

Speaker #2: We are targeting to initiate physician-sponsored trials as early as this year, to provide proof of efficacy and a basis to initiate our Phase 2B studies in the future.

Speaker #2: There is a significant upside also, in addition to these large oncology markets. While we pursue these high-value commercial markets, while not being our core focus, we are additionally seeking upside in the biodefense sector.

Speaker #2: In Tollimid, it is an ideal candidate for acute radiation syndrome with over 15 years of development and FDA fast track and orphan drug designation; it is uniquely positioned as a stockpiling agent for the national strategic stockpile.

Speaker #2: We are actively engaged with BARDA, NIAID, and the Department of War to secure non-dilutive government funding, assistance in testing and development of Tollimid for ARS.

Michael K. Handley: We are actively engaged with BARDA, NIAID, and the Department of War to secure non-dilutive government funding, assistance in testing and development of Entolimod for ARS. Entolimod's ability to be used both prophylactically and post-exposure, addressing both GI and hematopoietic damage, sets it apart from any current stockpiled alternative drug. Now on to Velocity Bioworks. A cornerstone of our strategy is Velocity Bioworks, a wholly owned contract development and manufacturing organization that we acquired in December, as noted in our press releases in December. By internalizing our manufacturing, we have already achieved substantial reduction in development timelines and costs for Entolimod. Additionally, we have controlled our own supply chain and are poised to scale Entolimod as needed. Velocity Bioworks is a mission-critical asset for government partnerships, ensuring domestic control over the drug supply chain.

Michael Handley: We are actively engaged with BARDA, NIAID, and the Department of War to secure non-dilutive government funding, assistance in testing and development of Entolimod for ARS. Entolimod's ability to be used both prophylactically and post-exposure, addressing both GI and hematopoietic damage, sets it apart from any current stockpiled alternative drug. Now on to Velocity Bioworks. A cornerstone of our strategy is Velocity Bioworks, a wholly owned contract development and manufacturing organization that we acquired in December, as noted in our press releases in December. By internalizing our manufacturing, we have already achieved substantial reduction in development timelines and costs for Entolimod. Additionally, we have controlled our own supply chain and are poised to scale Entolimod as needed. Velocity Bioworks is a mission-critical asset for government partnerships, ensuring domestic control over the drug supply chain.

Speaker #2: Tollimid's ability to be used both prophylactically and post-exposure, addressing both GI and hematopoietic damage, sets it apart from any current stockpiled alternative drug.

Speaker #2: Now, on to Velocity Bioworks. A cornerstone of our strategy is Velocity Bioworks, a wholly owned contract development and manufacturing organization that we acquired in December, as noted by our press releases in December.

Speaker #2: By internalizing our manufacturing, we have already achieved substantial reduction in development timelines and costs for Tollimid. Additionally, we have controlled our own supply chain and are poised to scale Tollimid as needed.

Speaker #2: Velocity Bioworks is a mission-critical asset for government partnerships, ensuring domestic control over the drug supply chain; it also serves as a standalone revenue driver.

Michael K. Handley: It also serves as a standalone revenue driver, targeting the early-stage biologics manufacturing gap for phase 1 and phase 2 biotech firms. At full utilization, Velocity Bioworks has the potential to evolve in a self-sustaining cash flow positive operation. Now, our vision for our future. Tivic now stands at the intersection of several powerful macro trends: the demand for domestic biomanufacturing, the expansion of the immunotherapy market, and the urgent global mandate for national preparedness through medical countermeasures. By integrating a late-stage immunotherapy platform with dedicated in-house manufacturing, Tivic is positioned to save lives while building a high-growth enterprise. We are building the infrastructure for the next generation of biotherapeutic success. I look forward to providing further updates as we continue our journey together. Thank you. With that overview, I'll now turn it over to our CFO, Lisa Wolfe.

Michael Handley: It also serves as a standalone revenue driver, targeting the early-stage biologics manufacturing gap for phase 1 and phase 2 biotech firms. At full utilization, Velocity Bioworks has the potential to evolve in a self-sustaining cash flow positive operation. Now, our vision for our future. Tivic now stands at the intersection of several powerful macro trends: the demand for domestic biomanufacturing, the expansion of the immunotherapy market, and the urgent global mandate for national preparedness through medical countermeasures. By integrating a late-stage immunotherapy platform with dedicated in-house manufacturing, Tivic is positioned to save lives while building a high-growth enterprise. We are building the infrastructure for the next generation of biotherapeutic success. I look forward to providing further updates as we continue our journey together. Thank you. With that overview, I'll now turn it over to our CFO, Lisa Wolfe.

Speaker #2: Targeting the early-stage biologics manufacturing gap for phase 1 and phase 2 biotech firms, at full utilization, velocity bioworks has the potential to evolve in a self-sustaining cash flow positive operation.

Speaker #2: Now, our vision for our future. Tivic now stands at the intersection of several powerful macro trends: the demand for domestic biomanufacturing, the expansion of the immunotherapy market, and the urgent global mandate for national preparedness through medical countermeasures.

Speaker #2: By integrating a late-stage immunotherapy platform with dedicated in-house manufacturing, Tivic is positioned to save lives while building a high-growth enterprise. We are building the infrastructure for the next-generation biotherapeutic success.

Speaker #2: I look forward to providing further updates as we continue our journey together. Thank you. With that overview, I'll now turn it over to our call over to see our CFO, Lisa Wolf.

Speaker #1: Thank you, Mike. For ease of listening, all of the financial metrics I'll be reporting today compare the year-end at December 31, 2025, to the prior year-end at December 31, 2024.

Lisa Wolf: Thank you, Mike. For ease of listening, all of the financial metrics I'll be reporting today compare the year ended 31 December 2025 to the prior year ended 31 December 2024. You will hear me reference a range of earnings for certain items such as net loss before discontinued operations, and net loss. We're in the process of finalizing certain accounting matters related to the $16.3 million debt instrument dated 10 December 2025. We will be filing our 10-K on or before 31 March 2026, which will reflect our final results. Financial results for the year ended 31 December 2025 reflect our transition as a company with our focus towards the biopharmaceutical market and away from the consumer device market, which we exited at the end of 2025. All income and expense related to the consumer device business have been presented as discontinued operations in our financial statement.

Speaker #1: You will hear me reference a range of earnings for certain items such as net loss before discontinued, operations, and net loss. We're in the process of finalizing certain accounting matters related to the 16.3 million debt instrument dated December 10, 2025.

Speaker #1: We will be filing our 10-K on or before March 31, 2026, which will reflect our final results. Financial results for the year ended December 31, 2025, reflect our transition as a company, with our focus shifting towards the biopharmaceutical market and away from the consumer device market, which we exited at the end of 2025.

Speaker #1: All income and expense related to the consumer device business have been presented as discontinued operations in our financial statement. Operating expenses were $7.9 million, compared to $4.5 million, for the year-end at December 31, 2024.

Lisa Wolf: Operating expenses were $7.9 million, compared to $4.5 million for the year ended 31 December 2024. The increase was primarily due to the introduction of the biopharma business in February 2025, when the company licensed certain biologics and increased our headcount and professional services to support the development of Entolimod. Additionally, in December 2025, we formed Velocity Bioworks and hired 45 employees to support the CDMO operation. Loss from discontinued operations decreased from $1.2 million to $900,000 for the year ended 31 December 2025. Discontinued operations included all activities related to the consumer product business that Tivic exited in 2025. During 2025, we reduced advertising and marketing spend related to the business to focus resources on our TLR5 program. In December 2025, we acquired all of the assets of Scorpius Holdings, Inc. through an asset purchase agreement.

Speaker #1: The increase was primarily due to the introduction of the biopharma business in February 2025, when the company licensed certain biologics and increased our headcount and professional services to support the development of Intolimod.

Speaker #1: Additionally, in December 2025, we formed Velocity Bioworks and hired 45 employees to support the CDMO operation. Loss from discontinued operations decreased from $1.2 million to $900,000 for the year ended December 31, 2025.

Speaker #1: Discontinued operations included all activities related to the consumer product business that Tivic exited in 2025. During 2025, we reduced advertising and marketing spend related to the business to focus resources on our TLR5 program.

Speaker #1: In December 2025, we acquired all of the assets of Scorpius Holdings, Inc., through an asset purchase agreement. The total purchase price was $16.3 million, and with financed by entering into a securities purchase agreement for the issuance of a senior secured convertible note in the amount of $16.3 million, and a warrant to purchase up to an aggregate of $4,553,213 shares of our common stock.

Lisa Wolf: The total purchase price was $16.3 million and was financed by entering into a securities purchase agreement for the issuance of a senior secured convertible note in the amount of $16.3 million and a warrant to purchase up to an aggregate of 4,553,213 shares of our common stock. At 31 December 2025, cash and cash equivalents totaled $12.6 million, compared with $2 million at 31 December 2024. We also have $6 million of funds remaining in planned tranches of our preferred purchase agreement entered into in December 2025. Subsequent to year-end, in February, we entered into a common stock purchase agreement whereby we have the right, but not the obligation, to raise up to $50 million under certain conditions for approximately the next two years.

Speaker #1: At cash and cash equivalents totaled $12.6 million, compared with $2.0 million at December 31, 2024. We also have $6.0 million of funds remaining in plan tranches of our preferred purchase agreement entered into in December 2025.

Speaker #1: Subsequent to year-end in February, we entered into a common stock purchase agreement whereby we have the right, but not the obligation, to raise up to $50 million under certain conditions for approximately the next two years.

Speaker #1: We believe we're positioned to continue our progress toward GMP manufacturing validation for Intolimod and ramp operations of our CDMO with the intent to bring in third-party customers over the next year.

Lisa Wolf: We believe we're positioned to continue our progress toward GMP manufacturing validation for Entolimod and ramp operations of our CDMO with the intent to bring in third-party customers over the next year. With that, I'll turn the call back over to Mike.

Speaker #1: With that, I'll turn the call back over to Mike.

Speaker #2: Thank you, Lisa. In closing, while 2025 marked a fundamental transformation for Tivic, it is only the beginning of our journey. By securing the TLR5 platform, establishing vertical integration through our biomanufacturing capabilities, and repositioning the company as a focused immunotherapy organization, we have built a robust foundation for growth and value creation.

Michael K. Handley: Thank you, Lisa. In closing, while 2025 marked a fundamental transformation for Tivic, it is only the beginning of our journey. By securing the TLR5 platform, establishing vertical integration through our biomanufacturing capabilities, and repositioning the company as a focused immunotherapy organization, we have built a robust foundation for growth and value creation. This structure allows us to capture immediate opportunities in national preparedness while simultaneously driving long-term value in the multi-billion-dollar global oncology supportive care markets. I want to thank our employees for their dedication, our partners for their collaboration, and our shareholders for their continued confidence. We are committed to executing our vision and look forward to providing further updates as we reach our upcoming milestones. Thank you.

Michael Handley: Thank you, Lisa. In closing, while 2025 marked a fundamental transformation for Tivic, it is only the beginning of our journey. By securing the TLR5 platform, establishing vertical integration through our biomanufacturing capabilities, and repositioning the company as a focused immunotherapy organization, we have built a robust foundation for growth and value creation. This structure allows us to capture immediate opportunities in national preparedness while simultaneously driving long-term value in the multi-billion-dollar global oncology supportive care markets. I want to thank our employees for their dedication, our partners for their collaboration, and our shareholders for their continued confidence. We are committed to executing our vision and look forward to providing further updates as we reach our upcoming milestones. Thank you.

Speaker #2: This structure allows us to capture immediate opportunities in national preparedness while simultaneously driving long-term value in the multibillion-dollar global oncology supportive care markets. I want to thank our employees for their dedication, our partners for their collaboration, and our shareholders for their continued confidence.

Speaker #2: We are committed to executing our vision and look forward to providing further updates as we reach our upcoming you.

Operator: This concludes today's conference call. You may now disconnect your lines.

Q4 2025 Tivic Health Systems Inc Earnings Call

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