Tivic Health Systems (TIVC) Conference Transcript

Tivic Health Systems (TIVC) Conference Summary Company Overview - Tivic Health Systems is a late-stage diversified immunotherapeutics company focused on harnessing the immune system to fight diseases and restore health [3][4] - The company has transitioned from a single product company to a diversified portfolio, including a program in vagus nerve stimulation and a phase three immunotherapy program [5][6] Key Developments - Tivic has licensed a phase three immunotherapy program involving two molecules, with significant prior funding of approximately $140 million from agencies like DARPA and DOD [5][12] - The company is positioned in a $183 billion market segment with multiple commercial and clinical catalysts expected in the next 18 months [7] Product Pipeline - The newly licensed asset, Entelimod, is engineered to activate specific receptors in the immune system, showing promising results in treating acute radiation syndrome [11][12] - The acute radiation syndrome treatment has demonstrated a threefold increase in survival rates in mouse trials after radiation exposure [16][17] - The company is also exploring applications for neutropenia, a condition with a current market of approximately $10 billion, expected to grow to over $20 billion by 2032 [21][22] Competitive Advantage - Tivic's approach combines bioelectronic and biologic therapies, targeting both overactive and underactive immune systems [8][30] - The company’s bioelectronic portfolio aims to modulate the vagus nerve non-invasively, presenting a compelling alternative to existing surgical solutions [32][40] Market Opportunities - The acute radiation syndrome indication is seen as a significant opportunity for stockpiling orders, potentially ranging from $25 million to $250 million [20] - The G-CSF market, which currently stands at $7.2 billion, is expected to grow to $14.5 billion, providing a substantial opportunity for Tivic’s products [26] Clinical Trials and Regulatory Pathways - All trials for acute radiation syndrome have been completed, and the company is looking to start new trials for neutropenia [42] - Tivic has initiated GMP manufacturing processes and is in discussions with the FDA for potential expedited pathways to market [19][15] Financial Position - The company has maintained a clean cap table with no debt and good trading volumes, regaining NASDAQ minimum bid compliance as of March 31 [6][44] - An $8.4 million financing has been signed, with plans for a shareholder meeting to approve announced financings [46] Conclusion - Tivic Health is at a pivotal point with a diversified portfolio and significant market opportunities, particularly in immunotherapy and bioelectronic medicine, positioning itself for potential growth and investment [3][48]