Tivic Health Systems (NASDAQ:TIVC) used its fiscal year and fourth quarter 2025 earnings call to outline what management described as a “defining” year of strategic transformation, highlighted by a shift away from its legacy consumer device business and toward immunotherapy development built around its toll-like receptor 5 (TLR5) platform.
In prepared remarks, newly appointed CEO Michael Handley said his focus is to evolve Tivic into an immunotherapy biopharmaceutical company aimed at advancing therapies to patients and creating long-term shareholder value. The company’s lead TLR5 candidate is Entolimod, alongside what it described as a next-generation successor, Entolasta.
Strategic pivot: exiting consumer devices, concentrating on TLR5
Management positioned Entolimod as a potential entrant in the oncology supportive care market, which Handley characterized as multi-billion-dollar and marked by significant unmet needs for next-generation protective agents. He said a large share of cancer patients undergoing radiation and/or chemotherapy experience serious side effects such as bone marrow suppression and gastrointestinal tissue damage, and that Entolimod has the ability to mitigate these effects.
Handley also said the market for existing G-CSF drugs is mature and faces biosimilar pricing pressure, but argued that therapies with different mechanisms—including TLR5 agonists—could target a “high-value, non-commodity” segment of what he described as an oncology supportive care market approaching $15 billion and expected to grow to $20 billion by the 2030s.
Clinical and commercialization priorities in oncology supportive care
Handley said Tivic is moving Entolimod into “large market clinical indications,” beginning with neutropenia. He stated the company is targeting physician-sponsored trials “as early as this year” to provide proof of efficacy and support future Phase 2B studies.
On the call, management emphasized Entolimod’s potential to protect both bone marrow and the gastrointestinal tract from radiation and chemotherapy damage, and said it may be used prophylactically in clinical settings.
Biodefense opportunity: acute radiation syndrome and government engagement
While describing oncology as the primary commercial focus, Handley said Tivic is also pursuing what he called “upside” in biodefense, pointing to Entolimod’s potential role in acute radiation syndrome (ARS). He said Entolimod has more than 15 years of development history and has FDA Fast Track and Orphan Drug designations, which he said position it as a candidate for inclusion as a stockpiling agent in the Strategic National Stockpile.
Handley said the company is engaged with U.S. government agencies including BARDA and NIAID, as well as the Department of War, seeking non-dilutive funding and development support for ARS-related testing and advancement. He also said Tivic has made “tremendous inroads” with interested parties in the U.S. government and allied international governments that are seeking radiation exposure countermeasures.
Velocity Bioworks acquisition: manufacturing control and potential revenue stream
A key element of Tivic’s new strategy is Velocity Bioworks, a contract development and manufacturing organization (CDMO) acquired in December. Handley described Velocity Bioworks as a wholly owned CDMO intended to internalize manufacturing, reduce development timelines and costs for Entolimod, and provide supply chain control and scaling capability.
He also characterized domestic manufacturing control as important for potential government partnerships, while describing the CDMO as a potential standalone revenue driver aimed at early-stage biologics manufacturing needs for Phase 1 and Phase 2 biotech companies. Handley said that at full utilization, Velocity Bioworks has the potential to become self-sustaining and cash-flow positive.
Financial update: higher operating expenses, Scorpius assets purchase, and financing capacity
Wolf said 2025 operating expenses were $7.9 million, compared with $4.5 million in 2024. She attributed the increase primarily to the February 2025 introduction of the biopharma business—when Tivic licensed certain biologics, increased headcount, and expanded professional services related to Entolimod development—as well as the December formation of Velocity Bioworks and the hiring of 45 employees to support CDMO operations.
Loss from discontinued operations decreased to $900,000 in 2025 from $1.2 million in 2024, which Wolf said reflected reduced advertising and marketing spend as Tivic redirected resources toward its TLR5 program.
Wolf also noted that the company is finalizing accounting matters related to a $16.3 million debt instrument dated Dec. 10, 2025, and therefore referenced ranges for certain earnings items. She said Tivic expects to file its Form 10-K for the year ended Dec. 31, 2025 on or before March 31, 2026.
On the Velocity Bioworks buildout, Wolf said Tivic acquired all assets of Scorpius Holdings, Inc. in December 2025 through an asset purchase agreement with a total purchase price of $16.3 million. She said the acquisition was financed through a securities purchase agreement that included 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 common stock.
Liquidity increased during the year, with cash and cash equivalents of $12.6 million as of Dec. 31, 2025, compared with $2.0 million at Dec. 31, 2024. Wolf added that the company had $6 million of funds remaining in planned tranches under a preferred purchase agreement entered into in December 2025. Subsequent to year-end, she said Tivic entered into a common stock purchase agreement in February that provides the right, but not the obligation, to raise up to $50 million under certain conditions over approximately the next two years.
Looking ahead, Wolf said management believes the company is positioned to continue progress toward GMP manufacturing validation for Entolimod and to ramp CDMO operations with the intent to add third-party customers over the next year.
Handley closed by reiterating that 2025 was the start of a broader journey, with Tivic aiming to pursue “immediate opportunities” in national preparedness while building longer-term value in oncology supportive care markets, supported by vertically integrated manufacturing capabilities.
About Tivic Health Systems (NASDAQ:TIVC)
Tivic Health Systems is a commercial-stage medical technology company that develops and markets non-drug, neuromodulation-based therapies for nasal and sinus health. The company’s solutions are designed to alleviate sinus pain, pressure and congestion through gentle microcurrent and vibration stimulation. By targeting the underlying nerve pathways in the nasal passages, Tivic Health aims to provide an alternative to over-the-counter and prescription medications without introducing systemic side effects.
The flagship product, ClearUP™ Sinus Pain Relief, is an FDA-cleared, hand-held device intended for home use.
