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Tivic Health shifts focus to biopharmaceuticals, discontinues device sales

March 24, 2026 9:32 AM

Tivic Health Systems (NASDAQ: TIVC) announced a strategic pivot to focus exclusively on its biopharmaceutical programs, discontinuing commercial sales of its ClearUP sinus device and suspending development of its non-invasive vagus nerve stimulation platform.



The San Antonio-based company will concentrate resources on Entolimod, a Toll-like receptor 5 agonist for acute radiation syndrome, and Entolasta, a second-generation TLR5 molecule. The company is pursuing opportunities in oncology supportive care, targeting conditions like neutropenia that affects up to half of cancer patients.



Chief Executive Officer Michael K. Handley, who previously led Statera Biopharma, outlined the company's government partnership strategy in a March 24 shareholder letter. Tivic is seeking funding from the Biomedical Advanced Research and Development Authority to advance Entolimod as a medical countermeasure for the Strategic National Stockpile.



The company reported achieving a 200-fold manufacturing scale-up of Entolimod using 50-liter fermentation through its wholly owned subsidiary Velocity Bioworks. The milestone met purity and potency specifications within budget and timeline expectations.



Velocity Bioworks operates as a contract development and manufacturing organization from a facility in San Antonio, providing services to third-party biopharmaceutical companies while supporting Tivic's internal pipeline. The subsidiary was established in December 2025 following acquisition of manufacturing assets from Scorpius Holdings.



Entolimod has received Fast Track and Orphan Drug designations from the FDA. The company's clinical pipeline includes applications for neutropenia treatment and lymphocyte exhaustion, with plans to explore oral formulations alongside the current injectable form.



Tivic scheduled a year-end earnings call for March 25 in conjunction with its Form 10-K filing.

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