Tivic Health Systems, Inc. ($TIVC)

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 3 months. 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. 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-end December 31, 2025, which is expected to be filed with the SEC on March 31, 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.

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. Finally, we have made tremendous inroads to interested parties in the U.S. 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 noncore 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 multibillion-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. A large number of these patients suffer from debilitating 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. While the market for existing G-CSF drugs, the current drugs out there to treat neutropenia and other disease states associated with cancer and radiation and chemo is mature and faces pricing pressure from biosimilars. There are significant unmet need for next-generation protective agents. Current treatments are 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 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. 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 IIb 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 our 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 National Strategic Stockpile. We are actively engaged with BARDA, NIAID and the Department of Water 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 hemopoietic 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 noticed by our press releases in December. By internalizing our manufacturing, we have already achieved substantial reduction in development time lines 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. It also serves as a stand-alone revenue driver, targeting the early-stage biologics manufacturing gap for Phase I and Phase II 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 biotherapeutic success. I look forward to providing further updates as we continue our journey together. Thank you. With that overview, I'll now turn our call over to our CFO, Lisa Wolf.

Thank you, Mike. For ease of listening, all of the financial metrics I'll be reporting today compare the year ended December 31, 2025, to the prior year ended December 31, 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 December 10, 2025. 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 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 statements. Operating expenses were $7.9 million compared to $4.5 million for the year ended December 31, 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 December 31, 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. 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 December 31, 2025, cash and cash equivalents totaled $12.6 million compared with $2 million at December 31, 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 2 years. We believe we're positioned to continue our progress towards 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.

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 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. We are committed to executing our vision and look forward to providing further updates as we reach our upcoming milestones. Thank you.

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