Tivic Health
Tivic Health (now Valion Bio) is a clinical-stage immunotherapeutics company developing Entolimod, a TLR5 agonist for Acute Radiation Syndrome and oncology supportive care, with FDA Fast Track and Orphan Drug designations and a wholly owned CDMO subsidiary, Velocity Bioworks.
- Company typePublic
- Founded2016
- HeadquartersMenlo Park, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Tivic Health does
Tivic Health (now operating under the Valion Bio brand) is a clinical-stage immunotherapeutics company that pivoted in 2025 from a consumer bioelectronic medicine business (the discontinued ClearUP sinus device) to a biopharmaceutical platform centered on Entolimod, a Toll-like Receptor 5 (TLR5) agonist being developed to activate the innate immune system for radiation protection and oncology supportive care. The lead indication is Acute Radiation Syndrome (ARS), pursued under the FDA's Animal Rule framework with Fast Track and Orphan Drug designations; follow-on indications target chemotherapy- and radiation-induced neutropenia, and a second-generation candidate (Entalasta) is in IND-enabling work for chronic indications. Entolimod has been administered to more than 300 humans in prior clinical studies, with $140+ million invested in the program across institutional and U.S. government funding.
Tivic's revenue model is split between (i) government funding and licensing for Entolimod development as a medical countermeasure, (ii) future stockpiling and commercial sales of Entolimod upon BLA approval, and (iii) independent third-party contract manufacturing revenue from its wholly owned Velocity Bioworks CDMO subsidiary, which was launched in December 2025 following the acquisition of cGMP manufacturing assets from Scorpius Holdings. The company is publicly traded on Nasdaq under ticker TIVC (rebranding toward VBIO), was founded in 2016, and is headquartered in Menlo Park with manufacturing operations in San Antonio, Texas.
Near-term customer concentration is heavy on a small number of U.S. federal agencies (BARDA, NIAID, DTRA, Department of War) plus emerging international interest from the Ukraine Ministry of Health. The company is pre-commercial for Entolimod, generating only $0.8M in 2024 revenue from residual ClearUP device sales (a 41% YoY decline), and reported an FY2025 net loss of approximately $8.8M–$9.1M. In December 2025, Tivic raised over $90 million led by 3i, LP to fund the Scorpius acquisition, and in March 2026 it appointed Amgen/Genentech veteran Michael K. Handley as CEO to lead the biopharmaceutical transition.
Tivic Health firmographics
Firmographics- Name
- Tivic Health
- Legal name
- Tivic Health Systems, Inc.
- Website
- https://tivichealth.com
- Company type
- Public
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Tivic Health (now Valion Bio) is a clinical-stage immunotherapeutics company developing Entolimod, a TLR5 agonist for Acute Radiation Syndrome and oncology supportive care, with FDA Fast Track and Orphan Drug designations and a wholly owned CDMO subsidiary, Velocity Bioworks.
- Ownership category
- akta.pro rank
Tivic Health industry classification
Industry- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Ambulatory Health Care Services (621)
- SIC
- Pharmaceutical Preparations (2834), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB)
- akta.pro secondary industry
- Allied Health & Rehab Referral Platforms (PT/OT/SLP) (HLALALAI)
Keywords
Where Tivic Health is headquartered
LocationHeadquarters
- HQ city
- Menlo Park
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Tivic Health business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain
Revenue model
- Biopharmaceutical Development and Licensing: Advancing Entolimod toward Biologics License Application for Acute Radiation Syndrome and oncology supportive care indications. Revenue from licensing, government stockpiling contracts, and potential commercial sales.
- CDMO Services (Velocity Bioworks): Contract development and manufacturing services provided to third-party biotech companies. Generates independent commercial revenue serving outside clinical-stage biotech clients while supporting company's own supply chain.
- Government Funding and Contracts: Pursuing funding from BARDA, NIAID, DTRA, and other government agencies for Entolimod development as a medical countermeasure. Prior federal contracts totaling $35.6 million.
Go-to-market motion3 records
Distribution channels3 records
Marketing channels4 records
Tivic Health product offering
Product offeringCore offering
Valion Bio (the operating identity of Tivic Health Systems) is a clinical-stage immunotherapeutics company developing Entolimod, a Toll-like Receptor 5 (TLR5) agonist, for Acute Radiation Syndrome and oncology supportive care indications such as chemotherapy- and radiation-induced neutropenia. It also owns Velocity Bioworks, a U.S.-based contract development and manufacturing organization (CDMO) that provides cGMP biomanufacturing services to outside biotech clients while supporting its own supply chain.
Product overview
Tivic Health Systems has transitioned from a medical device company to a late-stage immunotherapeutics/biopharmaceutical firm. The current product portfolio centers on Entolimod, a TLR5 agonist drug candidate with Fast Track and Orphan Drug designations for Acute Radiation Syndrome, being developed under the FDA's Animal Rule framework. The company operates through its wholly-owned Velocity Bioworks CDMO subsidiary acquired in December 2025, which handles manufacturing and serves external clients. Prior products including the FDA-cleared ClearUP sinus device and vagus nerve stimulation platform were discontinued/suspended in 2025. A second-generation follow-on candidate called Entalasta is in IND-enabling stages.
Differentiator
Problem solved
Functional benefit
Brands
- Velocity Bioworks: A contract development and manufacturing organization (CDMO) subsidiary providing cGMP biomanufacturing services for Entolimod and third-party biotech clients.
Quantifiable outcome
- Odds ratio of 7.9 in post-hoc pooled analysis of RS-23 study for survival benefit
- +3 more outcomes
Companies that use Tivic Health
Customer profileNamed customers5 records
Segments4 records
Tivic Health technology and API
TechnologyAPI detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Tivic Health partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- U.S. Department of WarcoreSelected to present Entolimod radiation countermeasure candidate and oral transmucosal delivery program to Department's Tech Watch program. Department expressed encouraging interest in advancing discussions regarding national defense preparedness applications.
- Ukraine Ministry of HealthminorReceived Request for Information from Ukrainian Ministry of Health to evaluate Entolimod for inclusion in Ukraine's national strategic reserves against Acute Radiation Syndrome. Company aims to establish pathway for accelerated approval and stockpiling.
- NIAID (National Institute of Allergy and Infectious Diseases)coreAgreement with NIAID to fund and conduct preclinical studies evaluating Entolimod for gastrointestinal acute radiation syndrome. Studies starting with mouse models and potentially progressing to non-human primates.
- BARDA (Biomedical Advanced Research and Development Authority)coreOngoing discussions with BARDA regarding clinical data and potential funding for Entolimod as a medical countermeasure for the Strategic National Stockpile. Key government attendees recommended follow-up meetings after viewing drug's differentiated properties and manufacturing readiness.
- Scorpius HoldingscoreAcquired cGMP manufacturing and development assets from Scorpius Holdings, securing U.S.-based manufacturing site for Entolimod and launching Velocity Bioworks as a CDMO subsidiary.
- Scorpius BiomanufacturingcoreCollaboration with Scorpius Biomanufacturing for verification of Entolimod cell line and successful production and testing of Entolimod proteins toward establishing CGMP manufacturing for BLA filing.
- Statera BiopharmacoreExclusive license from Statera Biopharma for late-stage TLR5 agonist Entolimod to treat acute radiation syndrome. Tivic also appointed Michael Handley as COO and President of Tivic Biopharma, previously from Statera Biopharma.
Scale indicators14 records
Recent moves7 records
Tivic Health competitors and assessment
Company assessmentOthers
- Catalent: Leading global CDMO providing biologic manufacturing services comparable to Velocity Bioworks' offering. Relevant as a scaled comparable for the CDMO business line revenue opportunity.
Direct peers
- Soligenix: Clinical-stage biopharmaceutical company developing biodefense and rare disease therapeutics, including radiation injury countermeasures under FDA Animal Rule pathways. Comparable in scale, regulatory strategy, and government procurement focus.
- SIGA Technologies: Develops TPOXX for smallpox as a biodefense medical countermeasure with substantial U.S. government stockpiling contracts. Comparable as a small-cap biodefense company reliant on Strategic National Stockpile procurement.
- CEL-SCI Corporation: Late-stage immunotherapy company developing Multikine for head and neck cancer with similar small-cap, pre-commercial profile. Comparable as a clinical-stage immunotherapeutics peer facing regulatory and capital-raising challenges.
- Cleveland BioLabs (CBLI) / Genome Protection: Original developer of the Entolimod TLR5 agonist platform; pursuing radiation countermeasure and oncology supportive care applications. Direct comparable as the originator of Tivic's licensed technology.
Broad incumbents
- Emergent BioSolutions: Established biodefense leader with a portfolio of FDA-approved medical countermeasures (anthrax, smallpox, botulism) and major government stockpiling contracts. Represents the scaled incumbent Tivic could emulate in the radiation countermeasure niche.
- Bavarian Nordic: Global biodefense company with FDA-approved JYNNEOS/IMVANEX smallpox vaccine and significant BARDA contracts. Comparable as a publicly traded biodefense company pursuing government stockpiling revenue.
- Novavax: Vaccine developer with government pandemic preparedness contracts and BARDA funding history. Comparable as a biodefense-adjacent company scaling biomanufacturing for government stockpiling.
Emerging players
- Altimmune: Clinical-stage biopharmaceutical with biodefense (NasoShield anthrax vaccine) and metabolic disease programs pursuing BARDA funding. Comparable as a small-cap peer pursuing government stockpiling pathways.
- Tonix Pharmaceuticals: Clinical-stage company developing infectious disease countermeasures and CNS therapeutics with prior biodefense contracts. Comparable as a small-cap public biopharma pursuing government countermeasure opportunities.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Tivic Health social profiles
Digital presenceTivic Health compliance and trust
Trust signalCompliance3 records
Tivic Health financial estimates
Financial estimateRevenue estimate
Valuation estimate
Tivic Health leadership team
Management profileNumber of profiles
Tivic Health subsidiaries and ownership
Company hierarchySubsidiaries1 record
Tivic Health funding detail
Funding detailFunding overview
Funding rounds13 records
Investors14 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Tivic Health M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Tivic Health
What does Tivic Health do?
Valion Bio (the operating identity of Tivic Health Systems) is a clinical-stage immunotherapeutics company developing Entolimod, a Toll-like Receptor 5 (TLR5) agonist, for Acute Radiation Syndrome and oncology supportive care indications such as chemotherapy- and radiation-induced neutropenia. It also owns Velocity Bioworks, a U.S.-based contract development and manufacturing organization (CDMO) that provides cGMP biomanufacturing services to outside biotech clients while supporting its own supply chain.
Is Tivic Health a public or private company?
Tivic Health is a public company. It is currently operating.
When was Tivic Health founded?
Tivic Health was founded in 2016. It employs 11 to 50 people.
Where is Tivic Health based?
Tivic Health is headquartered in Menlo Park, United States, in the North America region.
How does Tivic Health make money?
Three revenue lines are on record. Biopharmaceutical Development and Licensing is the primary driver. The others are CDMO Services (Velocity Bioworks) and government Funding and Contracts.
Who are Tivic Health's main competitors?
Catalent is listed as an others. Direct peers are Soligenix, SIGA Technologies, CEL-SCI Corporation and Cleveland BioLabs (CBLI) / Genome Protection. Broad incumbents are Emergent BioSolutions, Bavarian Nordic and Novavax. Emerging players are Altimmune and Tonix Pharmaceuticals.
Does Tivic Health have an API?
No public API is recorded for Tivic Health.
What industry is Tivic Health in?
Its primary akta.pro industry code is HLAIAGAB, Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy), with a secondary code of HLALALAI, Allied Health & Rehab Referral Platforms (PT/OT/SLP). Its NAICS code is 325414 and its SIC code is 2834.