Tivic Health Systems (NasdaqCM:TIVC) Conference Transcript

Summary of Tivic Health Conference Call Company Overview - Company: Tivic Health - Ticker Symbol: TIVC (Nasdaq) - Focus: Transitioning into a biopharmaceutical company with late-stage assets, particularly in radiation treatment and oncology [1][2] Core Points and Arguments - Transformation: Tivic Health has completed a major overhaul, focusing on harnessing the immune system to improve clinical outcomes, particularly in radiation treatment [2] - Intolamod: - Licensed drug with significant prior investment ($140 million) and government support ($36 million) aimed at treating acute radiation syndrome [3] - Potential applications in oncology, with a well-characterized mechanism of action supported by over 40 studies [4] - Market Opportunity: - Current standard of care in the acute radiation syndrome market is valued at $9.4 billion, primarily addressing blood disorders from radiation exposure [5] - Intolamod could replace existing G-CSF drugs and provide protective benefits while supporting regeneration of fast-growing cells [6] - Commercialization Milestones: - Successful scaling of manufacturing from small batch to 200x, maintaining or exceeding purity and potency levels [8] - Plans to file a Biologics License Application (BLA) with the FDA, with Fast Track and Orphan Drug Designation already secured [8] - Government Interest: Significant interest from the U.S. government as a medical countermeasure for nuclear disasters, alongside oncology applications [9] - Strategic Moves: - Acquisition of manufacturing assets to bring production in-house, ensuring cGMP manufacturing access and reducing time to market [10] - Establishment of a contract development and manufacturing organization (CDMO) for phase one and two biologics, creating an additional revenue stream [11] - Financial Position: Recently closed a financing package allowing access to up to $75 million, targeting multiple high-value therapeutic inflection points within the next 18 to 24 months [12] Additional Important Content - Regulatory Pathway: The company is drafting its BLA and anticipates starting investigator-led trials in oncology applications this year [9] - Partnership Opportunities: Intolamod's unique position in both acute radiation syndrome and oncology creates real partnering opportunities as the company progresses [10] - Location Advantage: The San Antonio facility is strategically positioned to serve U.S. government requirements, with proximity to military bases and airports for emergency product transport [11]