Tivic Health (TIVC) Q2 2025 Earnings Transcript

Financial Performance - Revenue net of returns was $86,000 for the quarter, down from $140,000 in the prior year, and $156,000 for the first half of 2025 compared to $474,000 for 2024, attributed to decreased unit sales of ClearUp due to reduced marketing expenditures [24][25] - Gross margin increased to 63% for the second quarter, up from 21% a year ago, and 67% from 42% for the first half of 2025 compared to 2024, driven by reduced product support and fulfillment costs [25][26] - Operating expenses rose to $2.0 million for the second quarter from $1.3 million in the prior year, primarily due to increased research and biologics investment, while net loss was $1.9 million compared to $1.3 million in the prior year [3][26] Strategic Shift - The company plans to exit the consumer health technology business and focus exclusively on prescription-based therapeutics, citing underperformance in ClearUp sales [5][22] - An exclusive license was obtained for Sotero Biopharma's TLR5 agonist portfolio, including entolimod, which is seen as a potential growth engine with significant U.S. government contract opportunities for Acute Radiation Syndrome (ARS) [5][8] - Management is pursuing regulatory progress for entolimod, which has received fast track designation and orphan drug status, with a type B FDA meeting planned to advance a Biologic License Application (BLA) filing [5][15] Clinical Development and Manufacturing - GMP manufacturing validation for entolimod has been initiated with Scorpius Biomanufacturing, moving towards key biologics license application steps [6][16] - The company completed all study visits in an optimization study for the noninvasive cervical vagus nerve stimulation (NCVNS) device, with results expected later this year [6][21] - The potential market for neutropenia drugs is estimated between $19 billion to $24 billion, with entolimod positioned to address this market by preventing cell death during radiation treatment [17][18] Leadership and Talent Acquisition - Lisa Wolf has been confirmed as CFO, with key hires from Statera to support regulatory, clinical, and business development efforts [7][28] - The company has made significant adjustments to its staff to align with the new strategic focus, including the transition of the chief scientific officer to a consultancy role [7][28] Future Outlook - The company anticipates completing the transfer of existing INDs from Statera, cell line verification, and the first batch of GMP materials, along with reporting on the VNS trial results [30] - Management emphasizes the importance of the entolimod opportunity, with a single contract for ARS potentially totaling several hundred million dollars [9][13]