Tivic Health Systems, Inc. (NASDAQ: TIVC) Q2 2025 Earnings Call | 08/15/2025

Tivic Health Systems, Inc. presented its Q2 2025 financial results and operational updates, highlighting its strategic pivot into the biopharmaceutical sector through the licensing of Statera Biopharma’s TLR5 agonist portfolio and advancements in its vagus nerve stimulation (VNS) program. The company announced plans to exit the consumer health tech business by year-end to focus on prescription-based therapeutics.

Key Highlights

1. Strategic Pivot to Biopharmaceuticals

   • TLR5 Agonist Portfolio: Tivic acquired an exclusive worldwide license for Statera Biopharma’s TLR5 agonist assets, including Entolimod (a Phase III-ready drug candidate for acute radiation syndrome, ARS) and Entelasta (for radiation/chemotherapy side effects like neutropenia and GI damage).

     • ARS Opportunity: Entolimod targets national stockpiles and U.S. defense agencies for ARS, with potential contracts worth hundreds of millions. Recent meetings at the Military Health System Research Symposium (MHSRS) validated government interest.

     • Regulatory Progress: Entolimod has FDA fast-track and orphan drug designations for ARS (pediatric). A Type B meeting with the FDA is planned for 2025 to confirm clinical, manufacturing, and validation requirements for a Biologic License Application (BLA). Discussions for emergency use authorization are ongoing.

     • Manufacturing: GMP manufacturing validation for Entolimod began with Scorpius Biomanufacturing in May 2025. Bioequivalence and biostability testing will follow, with the latter expected to take ~1 year.

     • Neutropenia Market: Entolimod and Entelasta target a $19–24 billion neutropenia market, offering broader immune system benefits compared to existing GCSF drugs by preventing cell death and promoting cell preservation.

   • IND Transfer: Tivic is transferring two existing Investigational New Drug (IND) applications from Statera to enable formal FDA engagement.

2. Vagus Nerve Stimulation (VNS) Program

   • Completed all study visits for an optimization trial of a patent-pending non-invasive cervical VNS device in June 2025. Initial findings emphasize personalization for therapeutic efficacy, with potential to match or exceed surgically implanted VNS devices.

   • The Feinstein Institute is preparing a report on trial findings, expected later in 2025.

   • The VNS program complements the biologics pipeline, targeting immune dysregulation in cardiac, neurologic, and autoimmune conditions.

3. Exit from Consumer Health Tech

   • Tivic plans to divest, spin off, or complete a strategic transaction for its consumer health tech business (ClearUp) by year-end 2025 due to underperforming sales.

   • Resources are being redirected to focus on prescription-based therapeutics for greater shareholder value.

4. Financial Performance

   • Revenue: $86,000 in Q2 2025 (down from $140,000 in Q2 2024) and $156,000 for H1 2025 (down from $474,000 in H1 2024), due to reduced ClearUp sales and marketing spend.

   • Cost of Sales: Decreased to $32,000 in Q2 2025 (from $110,000) and $52,000 in H1 2025 (from $277,000), driven by lower unit sales and supply chain restructuring completed in August 2024.

   • Gross Margin: Improved to 63% in Q2 2025 (from 21% in Q2 2024) and 67% in H1 2025 (from 42% in H1 2024) due to reduced product support and fulfillment costs.

   • Operating Expenses: Increased to $2 million in Q2 2025 (from $1.3 million in Q2 2024) and $3.5 million in H1 2025 (from $3 million in H1 2024), driven by R&D investments in biologics, offset by reduced ClearUp marketing costs.

   • Net Loss: $1.9 million in Q2 2025 (vs. $1.3 million in Q2 2024) and $3.4 million in H1 2025 (vs. $2.7 million in H1 2024).

   • Cash Position: $1.2 million in cash and cash equivalents as of June 30, 2025 (down from $2 million at year-end 2024). Post-quarter, $0.9 million was raised via equity line of credit and Series B preferred stock sales. $7 million remains available from planned tranches of the preferred purchase agreement.

   • Debt: No debt on the balance sheet.

5. Organizational Changes

   • Lisa Wolf was appointed CFO, transitioning from interim CFO.

   • Hired key Statera team members for regulatory, quality, clinical operations, and business development to advance the Entolimod program.

   • Blake Gerfein stepped down as Chief Scientific Officer but remains a consultant for the VNS program.

6. Upcoming Milestones

   • Complete transfer of Statera INDs to Tivic.

   • Finish cell line verification and first batch of GMP materials for Entolimod.

   • Begin bioequivalence and biostability testing.

   • Report VNS optimization trial results.

   • Hold Type B FDA meeting for Entolimod to advance BLA preparation.