Theriva Biologics

What Theriva Biologics does

Theriva Biologics is a clinical-stage immuno-oncology company developing systemically administered oncolytic adenovirus therapeutics for solid tumors. The company's lead candidate, VCN-01 (zabilugene almadenorepvec), is an engineered adenovirus designed to selectively replicate within tumor cells while degrading tumor stroma via PH20 hyaluronidase expression and incorporating liver detargeting to enable intravenous administration. Headquartered in Rockville, Maryland with EU operations in Barcelona through its wholly-owned subsidiary Theriva Biologics S.L. (alongside VCN Bioscience S.L.), the company targets indications with significant unmet need including metastatic pancreatic ductal adenocarcinoma, refractory retinoblastoma, and immunotherapy-refractory head and neck squamous cell carcinoma.

The platform combines multiple antitumor mechanisms — selective tumor cell lysis, enhanced chemotherapy penetration through stromal degradation, and increased tumor immunogenicity — and is complemented by the Albumin Shield™ technology intended to protect oncolytic viruses from neutralizing antibodies to enable repeat dosing. Theriva also advances SYN-004 (ribaxamase), an oral beta-lactamase in development to prevent acute graft-versus-host disease in allogeneic hematopoietic cell transplant recipients, and previously developed SYN-020, an oral intestinal alkaline phosphatase now out-licensed to Rasayana Therapeutics. The company is publicly listed on NYSE American under ticker TOVX and trades through wholly-owned European subsidiaries supporting clinical operations.

Theriva generates no commercial product revenue and is funded primarily through dilutive capital raises, including public offerings, warrant inducement transactions, and a private placement of convertible preferred stock. Revenue model is licensing-driven, exemplified by the February 2026 out-licensing of SYN-020 to Rasayana Therapeutics for a $300,000 upfront and up to $38 million in development, regulatory, and sales milestones plus tiered single-digit royalties. Customers are not yet commercial — target end users are patients with the relevant cancer indications and their treating oncologists, with go-to-market contingent on FDA and EMA approval following the planned Phase 3 program.

Name

Theriva Biologics

Legal name

Theriva Biologics, Inc.

Website

https://therivabio.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Theriva Biologics is a clinical-stage immuno-oncology company developing systemically administered oncolytic adenovirus therapeutics, with lead candidate VCN-01 advancing through Phase 2b/3 trials for metastatic pancreatic cancer and refractory retinoblastoma.

Ownership category

akta.pro rank

Product category

Oncolytic Virus Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology Gene Therapies (incl. oncolytic vectors & gene-modified approaches) (HLAAACAF)

akta.pro secondary industries

Gene Therapy for Rare/Monogenic Diseases (HLAAACAE), Therapeutic Vaccines (e.g., Cancer/Chronic Infection) (HLAIAEAG)

Keywords

• Oncolytic virus therapeutics
• Immuno-oncology biologics
• Virotherapy cancer treatment
• Clinical-stage biopharmaceuticals
• Stroma-degrading adenovirus

Headquarters

HQ city

Rockville

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Licensing Revenue: The company generates licensing revenue through out-licensing of pipeline assets. In February 2026, Theriva licensed SYN-020 to Rasayana Therapeutics for up to $38 million in milestones plus royalties. Received $300,000 upfront payment with potential for $16M in development/regulatory milestones and up to $22M in sales milestones plus tiered single-digit royalties.
2. Warrant Inducement Transactions: Theriva raises capital through warrant exercise transactions with institutional investors. October 2025 warrant inducement raised approximately $4.0 million through exercise of existing warrants at reduced price, with issuance of new warrants.
3. Public Offerings: Company raises capital through public offerings of common stock and warrants. September 2024: $2.5 million public offering; May 2025: $7.5 million public offering of shares and warrants.
4. Pre-Revenue Stage: As a clinical-stage company, Theriva has no commercial product revenue. All revenue is from licensing deals and capital raises. Full-Year 2025: Net loss of $23.7 million with R&D expenses of $8.6 million.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

Theriva Biologics develops and clinically advances engineered oncolytic adenovirus therapeutics designed to selectively replicate within solid tumors, degrade the tumor stromal barrier via PH20 hyaluronidase expression, and stimulate anti-tumor immune responses. Lead clinical candidate VCN-01 (zabilugene almadenorepvec) is being developed for metastatic pancreatic ductal adenocarcinoma and refractory retinoblastoma, with the company's pipeline also including SYN-004 (ribaxamase) for transplant-related infections and SYN-020 (intestinal alkaline phosphatase, out-licensed in 2026).

Product overview

Theriva Biologics is a clinical-stage immuno-oncology company developing a portfolio of oncolytic virus therapeutics built on its proprietary oncolytic adenovirus platform. The company's lead clinical candidate is VCN-01 (zabilugene almadenorepvec), a stroma-degrading oncolytic adenovirus being advanced through Phase 3 development for pancreatic ductal adenocarcinoma and Phase 2/3 planning for retinoblastoma. The platform is complemented by the Albumin Shield™ technology designed to protect oncolytic viruses from neutralizing antibodies, enabling repeat dosing. The company also advancing SYN-004 (ribaxamase), an oral β-lactamase for prevention of graft-versus-host disease in transplant patients, and had out-licensed SYN-020 (intestinal alkaline phosphatase) to Rasayana Therapeutics for GI and metabolic disorders.

Differentiator

Problem solved

Functional benefit

Products and services

• VCN-01 (zabilugene almadenorepvec)

Quantifiable outcome

• Phase 2b VIRAGE trial met primary endpoints: improved overall survival, progression-free survival, and duration of response in metastatic PDAC patients receiving VCN-01 plus chemotherapy vs chemotherapy alone
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Rasayana TherapeuticscoreOEM/ Whitelabel/ Licensing Partner · 18 February 2026Theriva out-licensed SYN-020 (recombinant bovine intestinal alkaline phosphatase) to Rasayana Therapeutics for exclusive worldwide development and commercialization. Theriva received $300,000 upfront and is eligible for up to $38 million in development, regulatory, and sales milestones plus tiered single-digit royalties. Rasayana assumes all development costs and responsibilities. This allows Theriva to focus resources on VCN-01 pancreatic cancer program.
• Institut Català d'Oncologia (ICO)coreStrategic or Co-development PartnerSponsor of Phase 1 trial (NCT03799744) evaluating VCN-01 in combination with durvalumab for head and neck squamous cell carcinoma. Coordinating investigator Dr. Ricard Mesia leading the study at Catalan Institute of Oncology.
• University of PennsylvaniacoreStrategic or Co-development PartnerSponsor of Phase 1 trial (NCT05057715) evaluating VCN-01 in combination with huCART-meso cells for pancreatic and ovarian cancer patients.
• Fundació Sant Joan de DéucoreStrategic or Co-development PartnerSponsor of Phase 1 trial (NCT03284268) evaluating intravitreal VCN-01 for refractory retinoblastoma in pediatric patients at Barcelona Children's Hospital. Principal investigator Dr. Jaume Català-Mora.
• The University of LeedsminorStrategic or Co-development PartnerSponsor of Phase 1 trial evaluating IV VCN-01 in patients with high-grade brain tumors to assess safety and tumor penetration across blood-brain barrier.
• Washington University in St. LouiscoreStrategic or Co-development PartnerSponsor of Phase 1b/2a trial (NCT04692181) evaluating SYN-004 (ribaxamase) safety and tolerability in allogeneic hematopoietic cell transplant recipients receiving IV beta-lactam antibiotics.

Scale indicators14 records

Recent moves7 records

Expansion highlights2 records

Direct peers

• Replimune Group: Clinical-stage oncolytic virus company developing a proprietary platform (RP1, RP2, RP3) based on engineered herpes simplex virus for multiple solid tumor indications. Directly comparable to Theriva as a clinical-stage oncolytic virotherapy peer pursuing combination regimens with checkpoint inhibitors.
• CG Oncology: Clinical-stage immuno-oncology company developing oncolytic virus (cretostimogene grenadenorepvec) for bladder cancer. Comparable clinical-stage oncolytic virus platform peer with similar regulatory designations and Phase 3 development strategy.
• Akamis Bio (formerly PsiOxus Therapeutics): Oncolytic virus platform company developing systemically administered oncolytic adenoviruses (NG-942, NG-347) for solid tumors. Closely comparable as a developer of engineered, systemically deliverable oncolytic viruses.
• Istari Oncology: Clinical-stage oncolytic virus company developing PVSRIPO for recurrent glioblastoma and other solid tumors. Comparable as an oncolytic virus peer targeting high-unmet-need oncology indications with regulatory designations.
• Oncolytics Biotech: Clinical-stage company developing pelareorep, a systemically administered oncolytic reovirus for multiple cancers including pancreatic cancer. Comparable as a peer in systemic oncolytic virotherapy with combination strategies in PDAC.
• Transgene: Clinical-stage French biotech developing oncolytic viruses (TG6002, TG4050) and immunotherapy platforms for solid tumors. Comparable European-headquartered oncolytic virus peer with similar combination-therapy approach.

Emerging players

• DNAtrix: Clinical-stage developer of DNX-2401, an oncolytic adenovirus for glioblastoma. Comparable as an oncolytic adenovirus peer, though focused on a different oncology indication (brain tumors) than Theriva's lead programs.
• BioLineRx: Clinical-stage Israeli biotech developing Motixafortide and other oncology assets with focus on difficult-to-treat cancers. Comparable as a small-cap, clinical-stage oncology peer with similar capital-raising dynamics.

Broad incumbents

• Merck & Co. Major oncology incumbent with Keytruda (pembrolizumab) checkpoint inhibitor franchise across multiple solid tumors including pancreatic and HNSCC. Relevant as a combination partner and competitive context for Theriva's VCN-01 programs.
• AstraZeneca: Major oncology player with durvalumab (Imfinzi) checkpoint inhibitor, which Theriva is combining with VCN-01 in its HNSCC Phase 1 trial. Represents both a potential partner and competitive incumbent in the immunotherapy space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/TOVXBiologics
• LinkedInlinkedin.com/company/theriva-biologics

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries2 records

Funding overview

Funding rounds8 records

Investors3 records

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

M&A1 record

Investments

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

Frequently asked questions about Theriva Biologics