Tivic Health Systems (TIVC) investor relations material

Executive summary

• Initiated a strategic transformation in February, shifting from consumer health and bioelectronics to a focus on late-stage biologic pharmaceuticals, especially immunotherapeutics targeting the immune system and Entolimod for ARS and neutropenia.

• Acquired exclusive global license for Entolimod and Entolasta, completed transfer of two INDs, and expanded the clinical pipeline with plans for BLA submission and new clinical trials.

• Completed wind down of the consumer health business, including ClearUP, with reserves and write-offs recorded, and reallocated resources to biopharma development.

• Advanced discussions and engagement with government agencies for Entolimod as a military countermeasure and stockpile drug, including participation in the 2025 Military Health System Research Symposium.

• Reported new findings from the VNS Optimization Trial, leading to additional patent filings and insights into autonomic system modulation.

Financial highlights

• Q3 2025 revenue was $146,000, up from $126,000 in Q3 2024; nine-month revenue was $302,000, down 50% year-over-year due to reduced unit sales and advertising.

• Net loss for Q3 2025 was $2.6 million, compared to $1.4 million in Q3 2024; nine-month net loss was $6.0 million, up from $4.2 million.

• Gross margin for Q3 2025, excluding a $230,000 inventory reserve, was 42% versus 35% in Q3 2024; nine-month gross margin was 37%.

• Operating expenses rose to $2.3 million in Q3 2025 from $1.5 million in Q3 2024, driven by increased R&D and corporate costs.

• Cash and cash equivalents were $3.5 million as of September 30, 2025, up from $2.0 million at year-end 2024; no debt on the balance sheet.

Outlook and guidance

• Anticipates minimal to no revenue until regulatory approval and commercialization of new therapeutics, with significant revenue decline as consumer business winds down.

• Plans to move Entolimod directly into phase two clinical studies for neutropenia and lymphocyte exhaustion, with ongoing engagement with government agencies.

• Current and committed funds of $3.5 million, plus additional financing tranches, are expected to support CGMP manufacturing validation for Entolimod.

• Operating expenses projected to increase as biopharma development advances; additional capital will be required to fund operations and clinical trials.

• Management expresses substantial doubt about ability to continue as a going concern over the next 12 months without new financing.