Tivic Health Systems (TIVC) Emerging Growth Conference 89 summary

Corporate transformation and strategic focus

• Completed transformation into a biopharmaceutical company with late-stage assets and manufacturing readiness.

• Focused on immune system modulation for radiation treatment and clinical outcome improvement.

• In-licensed Entolimod, a drug with $140 million prior investment and $36 million in government support.

• Engaged with BARDA, Department of Defense, and White House, with upcoming presentations to key agencies.

• Entolimod has over 40 studies supporting its mechanism and potential.

Market opportunity and competitive landscape

• Current standard of care for acute radiation syndrome is a $9.4–$9.5 billion market, mainly addressing blood disorders.

• Entolimod offers broader benefits, including GI tract protection and regenerative effects, with no supportive care needed in trials.

• Market is under pressure from biosimilars; Entolimod could help major pharma renew leadership.

• Demonstrated potential to replace G-CSF drugs and become a new standard of care.

Manufacturing and commercialization milestones

• Revived and scaled up a dormant cell line, achieving a 200x increase in protein production with high purity and potency.

• Preparing for cGMP lot production, biostability testing, and BLA submission to the FDA.

• Fast Track and Orphan Drug Designation already granted; stockpile orders possible post-approval.