Tivic Health

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.

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

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

• Radiation countermeasures
• Immunotherapeutics development
• TLR5 agonist therapy
• Biopharmaceutical manufacturing
• Oncology supportive care

Headquarters

HQ city

Menlo Park

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. 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.
2. 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.
3. 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

Core 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

Named customers5 records

Segments4 records

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• U.S. Department of WarcoreStrategic or Co-development Partner · 15 April 2026Selected 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 HealthminorStrategic or Co-development Partner · 31 March 2026Received 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)coreStrategic or Co-development Partner · 26 March 2026Agreement 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)coreStrategic or Co-development Partner · 18 February 2026Ongoing 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 HoldingscoreStrategic or Co-development Partner · 11 December 2025Acquired 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 BiomanufacturingcoreStrategic or Co-development Partner · 10 September 2025Collaboration 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 BiopharmacoreOEM/ Whitelabel/ Licensing Partner · 21 March 2025Exclusive 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

Others

• 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

• Xx.com/TivicHealth
• Facebookfacebook.com/tivichealth

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

Funding overview

Funding rounds13 records

Investors14 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Tivic Health