Tivic Health Systems (TIVC) Conference Summary Company Overview - Tivic Health Systems is undergoing a significant transformation, shifting from a single product over-the-counter device company to a diversified immunotherapeutics company focused on immunotherapeutic applications and bioelectronic programs [3][4][31]. Core Business Developments - The company has licensed a phase three immunotherapy program, specifically a TLR five agonist, which includes two molecules and over 40 clinical trials, with a focus on acute radiation syndrome and additional indications in oncology and longevity [5][6][9]. - The TLR five program has received significant investment, totaling over $140 million, and has garnered interest from government agencies for its potential applications in emergency situations related to radiation exposure [10][11]. Product Pipeline and Market Potential - **Acute Radiation Syndrome (ARS)**: The TLR five drug, entolimod, has shown a threefold increase in survival rates in clinical trials and is on a fast track for FDA approval. The company is exploring emergency use designations to expedite market entry [12][15]. - **Neutropenia Market**: The market for neutropenia treatments is projected to exceed $20 billion by 2032, with TLR five drugs positioned to capture significant market share [17][20]. - **Vagus Nerve Stimulation (VNS)**: Tivic is developing a noninvasive VNS device, which has shown promising results in clinical trials, including a 60% decrease in gamma waves and a 2x increase in heart rate variability [21][23]. Strategic Positioning - The company is strategically positioned to leverage its dual approach of biologics and bioelectronic therapies to address immune system dysfunction across various diseases [7][8][31]. - Tivic Health aims to differentiate itself from competitors by offering noninvasive alternatives to existing implanted technologies, potentially expanding market access [25][27]. Financial and Operational Insights - The company has resolved previous Nasdaq deficiencies and currently has no debt, with a stable trading volume and a well-structured cap table [29][30]. - Recent financing efforts have provided sufficient capital to sustain operations for the next 12 to 18 months [44][45]. Distribution and Revenue Generation - The distribution strategy for the TLR five product will focus on government sales, requiring a limited sales team and leveraging existing consultant relationships [32][33]. - Revenue generation timelines are contingent on emergency use designations, with potential revenue starting within 12 to 18 months [34]. Challenges and Considerations - The company acknowledges the competitive landscape in the depression treatment market, which is heavily defended by pharmaceutical companies, and anticipates a complex regulatory pathway for its VNS device [36][38]. - The over-the-counter product line is currently breakeven, and the company is considering strategic alternatives for this segment [46][48]. Conclusion - Tivic Health Systems is positioned for growth through its innovative immunotherapeutic and bioelectronic product offerings, with a focus on addressing significant market needs in radiation exposure and immune system disorders. The company is actively pursuing regulatory pathways and strategic partnerships to enhance its market presence and financial stability [31][59].

Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $70,000, a decline from $334,000 in Q1 2024, primarily due to an 81% decrease in unit sales linked to a 92% reduction in advertising spend [11][12] - Cost of sales decreased to $20,000 from $167,000 in the prior year, resulting in an increase in gross margins from 50% to 72% [12] - Operating expenses remained flat at $1,600,000 for Q1 2025 compared to the same period in 2024, with a net loss of $1,500,000 for both quarters [12][13] - Cash and cash equivalents were $669,000 as of March 31, 2025, down from $2,000,000 at the end of 2024 [13] Business Line Data and Key Metrics Changes - The company transitioned from a single product focus to a diversified immunotherapeutics company, emphasizing a clinical pipeline targeting immune system dysregulation [4][5] - Significant investment was made in securing biopharmaceutical assets and supporting clinical research in non-invasive vagus nerve stimulation [9] Market Data and Key Metrics Changes - The treatment market for neutropenia is expected to reach $20 billion by 2029, indicating a substantial growth opportunity for the company [36] Company Strategy and Development Direction - The company is focused on enhancing shareholder value by prioritizing assets with the greatest potential for substantial returns, including the licensing agreement for entelimod [9][10] - A strategic shift towards immunotherapeutics is underway, with plans to advance both late and early-stage treatments in the pipeline [42] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the high economic uncertainty and the impact of reduced advertising on revenue, but emphasized the importance of capital management for future returns [10] - The company views 2025 as a year of tremendous opportunity with several key milestones expected in the second half of the year [44] Other Important Information - The FDA granted Fast Track status and orphan drug status for entelimod, with potential for accelerated pathways and emergency use designations [37] - The company has secured an $8.4 million tranche funding agreement to support its transformation [8] Q&A Session Summary - No specific questions and answers were provided in the content, as the call was pre-recorded and questions were submitted in advance.

Financial Data and Key Metrics Changes - Revenue for Q1 2025 totaled $70,000, a decline from $334,000 in Q1 2024, primarily due to an 81% decrease in unit sales linked to a 92% reduction in advertising spend [10][11] - Cost of sales decreased to $20,000 from $167,000 in the prior year, resulting in an increase in gross margins from 50% to 72% [11] - Operating expenses remained flat at $1,600,000 for Q1 2025 compared to the same period in 2024, with a net loss of $1,500,000 remaining unchanged year-over-year [11][12] - Cash and cash equivalents were $669,000 at the end of Q1 2025, down from $2,000,000 at the end of 2024, with working capital at $520,000 [12] Business Line Data and Key Metrics Changes - The company transitioned from a single product focus to a diversified immunotherapeutics company, emphasizing a clinical pipeline targeting immune system dysregulation [4][5] - Significant investment was made in securing and operationalizing biopharmaceutical assets, particularly in the licensing agreement with Staterra for entelimod and its derivative [8][14] Market Data and Key Metrics Changes - The market for neutropenia treatment is projected to reach $20 billion by 2029, indicating a significant opportunity for the company’s new drug candidates [33] - The company is positioned to address diseases caused by both underactive and overactive immune systems, which is a unique market opportunity [40] Company Strategy and Development Direction - The strategic focus is on enhancing shareholder value by prioritizing assets with the greatest potential for substantial returns, including the advancement of entelimod and the vagus nerve stimulation program [8][9] - The company aims to transition into high-value markets while managing capital to minimize dilution for investors [7][8] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of the licensing agreement with Staterra as a significant strategic shift, providing a foundation for growth and value creation [16][18] - The FDA granted Fast Track and orphan drug status to entelimod, with potential for accelerated pathways and emergency use designations [35] Other Important Information - The company has entered into an $8,400,000 tranche funding agreement to support its transformation and has secured a $25,000,000 equity line of credit [7][12] - The company is committed to advancing its non-invasive vagus nerve stimulation program, with ongoing clinical studies expected to yield results in the near future [39][40] Q&A Session Summary Question: What is the company's strategy regarding the new licensing agreement? - The licensing agreement with Staterra is seen as a major opportunity to accelerate value creation and leverage the company’s commercial infrastructure for long-term growth [14][16] Question: How does the company plan to address the decline in revenue? - The company intentionally reduced advertising spend to focus on capital resources for biopharmaceutical assets, which impacted revenue but is expected to lead to greater long-term value [10][11] Question: What are the expected milestones for entelimod? - The company is focused on validating the manufacturing process for entelimod and preparing for the biological licensing application with the FDA, with significant confidence in the collaboration for successful outcomes [36][40]