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Tivic Health Systems (TIVC) investor relations material
Tivic Health Systems Emerging Growth Conference 89 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
Next Tivic Health Systems earnings date
Next Tivic Health Systems earnings date
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