Tivic Health Systems (TIVC) Emerging Growth Conference 91 summary

Strategic focus and pipeline

• Emphasis on late-stage, de-risked biopharma assets targeting immune therapies for improved patient survival, with a focus on oncology and supportive care for radiation and chemotherapy side effects.

• Acute Radiation Syndrome (ARS) is the lead indication, having completed phase III and preparing for a BLA submission; neutropenia is the next target, ready for phase II.

• The TLR5 (Toll-like receptor 5) platform underpins the immunotherapy approach, enabling activation of anti-apoptotic pathways, hematopoiesis, and immune cell activation.

• Over 60 patents are pending for the platform, with significant investment and productive meetings with BARDA and other government agencies.

Clinical data and therapeutic applications

• Phase II studies at Mayo Clinic showed Entolimod can reverse immunosenescence in elderly, potentially extending lifespan and immune function.

• TLR5 agonists like Entolimod demonstrate tumor regression via NK and T cell recruitment, supporting a strong immuno-oncology focus.

• Entolimod targets neutropenia, cachexia, and thrombocytopenia, addressing major side effects of cancer therapies.

• ARS indication is furthest along, with phase III completed and manufacturing validation underway for commercial launch.

Market potential and regulatory progress

• The immune therapy market is valued at $183 billion, with large opportunities in immuno-oncology and supportive care.

• Entolimod is positioned as both a therapeutic and prophylactic, with single-dose administration and broad effects including GI protection and hematopoiesis.

• Ongoing discussions with the U.S. government and international partners for use as a radiation countermeasure and potential inclusion in the Strategic National Stockpile.

• Agreement with NIAID to fund studies demonstrating GI and bone marrow protection, supporting regulatory and stockpile ambitions.