Tivic Health Systems, Inc. Q2 FY2025 earnings call

• Expanded into biopharmaceutical sector and advanced work on next-generation vagus nerve stimulation devices.
• Exclusive licensing of Statera Biopharma's portfolio, including Entolimod for ARS with potential for multiple indications.
• Progress with Entolimod for ARS, including meetings with MHSRS, FDA interactions, and work with Scorpius on GMP manufacturing.
• Plan to exit Consumer Health Tech business by year-end to focus on prescription-based therapeutic pipeline.
• Staff adjustments, including hiring key team members for Entolimod program and Lisa Wolf joining as CFO.
• Milestones ahead: transferring INDs, cell line verification, GMP materials batch, bioequivalence testing, VNS trial results reporting, and Type B meeting with FDA.

For the second quarter ended June 30, 2025, revenue net of returns was $86,000 compared to $140,000 in the prior year quarter. For the first half of 2025, revenue net of returns was $156,000 compared to $474,000 in the prior year first half. The decline in revenue was due to decreased unit sales of ClearUP. Cost of sales decreased to $32,000 from $110,000 in the year ago quarter and to $52,000 from $277,000 for the 6-month period. Gross margins increased to 63% in the second quarter compared to 21% a year ago and to 67% for the first half of 2025 compared to 42% in 2024. Operating expenses were $2 million in the second quarter of 2025 compared with $1.3 million in the same period in 2024. Net loss was $1.9 million in the second quarter of 2025 compared with $1.3 million in the second quarter of 2024. Cash and cash equivalents totaled $1.2 million at June 30, 2025, and subsequent to the quarter's end, the company raised gross proceeds of $0.9 million through equity line of credit and Series B preferred stock sales.

• Funds from equity line of credit and Series B preferred stock sales, along with remaining planned tranches, will allow progress toward GMP manufacturing validation for Entolimod.
• Next milestones include completing IND transfers, cell line verification, first batch of GMP materials, bioequivalence validation, reporting VNS trial results, and Type B meeting with FDA.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated, as cautioned by the operator at the start of the call.