Tivic Health Systems (TIVC) Investor presentation summary

Strategic focus and assets

• Developing late-stage, de-risked biologics targeting radiation damage, oncology, and immune system modification.

• Portfolio includes Entolimod (late Phase III) and Entolasta (pre-clinical), both TLR5 agonists with broad applications.

• Secured exclusive global rights to TLR5 agonist portfolio in 2025, with $140M prior investment and 60+ patents.

• Integrated manufacturing and CDMO subsidiary (Velocity Bioworks) accelerate time-to-market and create new revenue streams.

• Management team with CEO, CFO, and President of Biopharma, ~50 employees, and IPO in 2021.

Clinical pipeline and market opportunity

• Entolimod addresses acute radiation syndrome (ARS), acute neutropenia, thrombocytopenia, immunosenescence, and general mucositis.

• Entolasta targets chronic radiation syndrome and is in pre-clinical development.

• Entolimod has demonstrated a 3x increase in survival rate for ARS and is supported by US government agencies.

• Global G-CSF and biosimilar market is $9.46B in 2024, projected to reach $21.3B by 2032 (10.7% CAGR).

• Entolimod offers a new class of therapy with both hemopoietic and GI tract protection, unlike current G-CSF drugs.

Competitive differentiation and commercialization

• Entolimod provides therapeutic, prophylactic, and regenerative benefits, covering neutrophils, platelets, and GI repair.

• Demonstrated highly differentiated results in preclinical models, including accelerated regeneration and apoptosis suppression.

• Commercialization milestones include cell line verification (Sept 2025), scale-up, cGMP production, and BLA filing with Fast Track and Orphan Drug status.

• Secured production capacity and international stockpile opportunities for ARS.

• Oncology expansion leverages ARS clinical foundation to reduce toxicities, preserve therapy delivery, and create compounding revenue streams.