Tivic Health Systems, Inc. Q3 FY2025 earnings call

• Strategic transformation started in February with licensing of entolimod and related assets, expanding from bioelectronics to biologic pharmaceuticals.
• In Q2, built team and secured first meetings for Entelimod as military countermeasure; expect to meet with BARDA for stockpiling. Commercial focus on Intaloupe's BLA with FDA for acute radiation syndrome.
• Licensed Entelimod and Entelasta for neutropenia, filed new IP for TLR5 agonist as adjunctive therapies for immuno-oncology. Completed optimization study for VNS device design; exiting consumer health market.
• Transferred two entolimod INDs, enabling clinical programs in neutropenia and lymphocyte exhaustion; anticipate Phase II studies. Verified entolimod cell line, made manufacturing progress despite contract manufacturer delays.
• VNS program optimization study revealed ability to influence sympathetic and parasympathetic activity, prompting reassessment of commercial focus.
• Launched new corporate website, recorded inventory reserves and wrote off assets related to exit from consumer device market, discontinued resources for clear up sales.

Revenue net of returns for the third quarter was $140,000, compared to $126,000 in the year-ago quarter. For the nine-month period, revenue net of returns was $302,000 compared to $600,000 in 2024. Cost of sales increased to $291,000 from $82,000 in the year-ago quarter in Q3 2025, primarily due to $230,000 inventory reserves. For the nine-month period, cost of sales decreased to $343,000 from $359,000, mainly due to lower unit sales offset by the inventory reserve. Gross margins excluding the $230,000 inventory reserve were 42% for Q3 2025 compared to 35% in the year-ago quarter, and 37% for the nine-month period compared to 40% in 2024. Operating expenses for Q3 2025 were $2,300,000 vs $1,500,000 in 2024, and for the nine-month period, $5,900,000 vs $4,400,000 in 2024. Net loss for Q3 2025 was $2,600,000 vs $1,400,000 in 2024, and for the nine-month period, $6,000,000 vs $4,200,000 in 2024.

• Closed additional tranches of $8,400,000 financing, totaling $3,800,000 in net proceeds during Q3.
• Believe funds along with remaining planned tranches will allow meaningful progress toward GMP manufacturing validation for entolimod, a key value inflection point.

• Contract manufacturer experienced financial stress, causing delays to original schedule but working to establish stability. - Forward-looking statements subject to risks and uncertainties causing actual results to differ from expectations, as per safe harbor statements and SEC filings.