Tivic Health Systems Conference Summary Company Overview - **Company**: Tivic Health Systems (NasdaqCM:TIVC) - **Focus**: Development of non-invasive medical devices targeting neural pathways and a strong late-stage pipeline in biopharmaceuticals, particularly in immunomodulation and cancer therapeutics [1][2] Key Points Transformation and Pipeline Development - Tivic Health has undergone a significant transformation by acquiring newly licensed assets, leading to a robust late-stage portfolio in biopharmaceuticals [2] - The company maintains a clean capital structure with no debt and anticipates significant value inflection points in the near future [2] Biopharmaceutical Focus - The company is focusing on immunomodulation, utilizing the immune system to combat diseases and improve health outcomes [3] - A biologic licensing agreement was established, including a phase three recombinant protein funded by BARDA for radiation countermeasures, with potential applications in cancer [3][4] Entolimod and Market Opportunities - **Entolimod**: A TLR5 agonist with dual capabilities to treat acute radiation syndrome and cancer-related conditions, showing a 300% increase in survival rates with a single dose [9][23] - The market for GCSF drugs, which Entolimod aims to compete against, is valued at approximately $7.2 billion in 2023, with a broader neutropenia market of around $20 billion [9][31] - Entolimod is positioned as a military countermeasure for nuclear disasters, with a potential market opportunity of $5.2 billion for stockpiling [9][10] Clinical and Regulatory Progress - The company has made significant strides in customer engagement and manufacturing agreements, moving towards a Biologics License Application (BLA) filing [5][10] - The FDA has granted fast track and orphan drug designations for Entolimod, facilitating expedited regulatory processes [11] Future Directions and Strategic Focus - The company plans to focus on Entolimod over the next 6 to 18 months while also exploring other high-potential areas, including cancer therapeutics and vagus nerve stimulation technologies [17][35] - By 2026, Tivic Health aims to have GMP materials ready, FDA meetings completed, and customer interest solidified [34] Additional Insights - The company operates with a capital-light model and has a strong team with extensive experience in drug launches and biopharmaceutical development [16][25] - There is potential for partnerships with larger organizations to scale production and market reach effectively [29] - The vagus nerve technology remains a promising area for future development, with established research backing its efficacy [13][12] Conclusion Tivic Health Systems is positioned for growth with its innovative biopharmaceutical pipeline, particularly through Entolimod, which addresses significant market needs in radiation countermeasures and cancer therapeutics. The company's strategic focus on regulatory pathways and partnerships will be crucial for its success in the coming years.

Financial Data and Key Metrics Changes - Revenue net of returns totaled $86,000 for Q2 2025 compared to $140,000 in Q2 2024, and $156,000 for the first half of 2025 compared to $474,000 for the first half of 2024, reflecting a significant decline due to decreased unit sales of ClearUp [16][17] - Cost of sales decreased to $32,000 from $110,000 in the year-ago quarter, and gross margins increased to 63% for Q2 2025 compared to 21% a year ago, driven by reductions in product support and fulfillment costs [17][18] - Net loss was $1,900,000 for Q2 2025 compared with $1,300,000 for Q2 2024, and $3,400,000 for the first half of 2025 compared with $2,700,000 for the first half of 2024 [18][19] Business Line Data and Key Metrics Changes - The decline in revenue was primarily due to reduced unit sales of ClearUp, as the company intentionally decreased marketing expenditures to focus on advancing its TLR5 program [17] - Operating expenses increased to $2,000,000 for Q2 2025 compared with $1,300,000 for Q2 2024, mainly due to increased research and development investments in the biologics program [18] Market Data and Key Metrics Changes - The market for neutropenia drugs is projected to be between $19 billion to $24 billion over the next few years, with entolimod potentially addressing a significant portion of this market [10] Company Strategy and Development Direction - The company is transitioning towards the biopharmaceutical market and away from the consumer device market, planning to exit the consumer health tech business by year-end [14] - The exclusive licensing of Sotero Biopharma's TLR5 portfolio is expected to provide a late-stage, highly derisked drug candidate, with significant sales potential from government contracts for acute radiation syndrome (ARS) treatments [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of entolimod and its derivatives to treat radiation and chemotherapy side effects, emphasizing the importance of their strategic pipeline [11][12] - The company is focused on advancing its clinical and commercial opportunities, with key milestones including the transfer of existing INDs and validation of GMP materials [22][23] Other Important Information - The company raised gross proceeds of $900,000 through equity financing, which will support progress towards GMP manufacturing validation for entolimod [19] - Management highlighted the importance of talent acquisition to support clinical work and government relations, indicating a strategic alignment with their new focus [21] Q&A Session Summary - No specific questions and answers were provided in the content, thus this section is not applicable.