Theriva Biologics, Inc.

Theriva Biologics, Inc. is a U.S.-based clinical-stage biotechnology company focused on developing therapeutics for cancer and related diseases. Its pipeline centers on oncolytic adenovirus programs, including VCN-01, along with earlier-stage assets and manufacturing technologies for viral therapeutics.

1.74

— Theriva Biologics, Inc.
	%
Oncolytic adenovirus therapeutics	70% Clinical-stage virus-based cancer therapies designed to selectively replicate in tumor cells and enhance anti-tumor response.
Non-oncology therapeutic candidates	15% Earlier-stage programs such as ribaxamase and SYN-020 targeting antibiotic-related and gastrointestinal diseases.
Viral manufacturing technology	10% THERICEL cell-line platform and related know-how for manufacturing viral and gene therapy products.
Licensing and collaboration arrangements	5% Out-licensing and partnered development rights for selected programs and technologies.

Theriva does not sell commercial medicines at scale; its primary counterparties are clinical trial sites, research...

Clinical trial investigators and sitesprimary
They administer VCN-01 and other pipeline studies and are essential for patient enrollment and data generation.
Patients with high-unmet-need cancersprimary
They are the intended recipients of oncolytic adenovirus therapies such as VCN-01 in pancreatic cancer and retinoblastoma.
Biopharma licensing partnerssecondary
They may license programs such as SYN-020 or collaborate on development and commercialization.
Research and manufacturing collaboratorssecondary
Academic and government partners support platform work such as THERICEL and AAV manufacturing adaptation.

Theriva is headquartered in the United States but its business is materially international because its core oncology...

•United States headquarters and primary corporate base
•Spain is important through the acquired Theriva Biologics, S.L. platform
•European collaborations support manufacturing and gene-therapy work
•Clinical trials may recruit internationally depending on indication
•No disclosed country revenue mix because the company is pre-commercial

Theriva’s strategy is to advance VCN-01 as its lead oncology asset while building optionality through next-generation...

Advance VCN-01 clinical developmentshort-term

VCN-01 is the lead asset and the main source of future value creation.

Pursue partnering and licensingshort-term

External funding and commercialization partners can reduce capital needs.

Build next-generation and manufacturing platformsmedium-term

VCN-X and THERICEL can broaden the technology base beyond a single asset.

Theriva is exposed to the typical risks of a clinical-stage biotech company: clinical trial failure, regulatory delay,...

critical

Funding and going-concern pressure

Later-stage trials require substantial capital and no committed financing is assured.

Scope: Company-wide development budget
Materiality: high

high

Clinical development failure

VCN-01 and other programs are unproven and depend on trial outcomes.

Scope: VCN-01, SYN-004, SYN-020, VCN-X
Materiality: high

high

Competitive displacement

Larger biotech and pharma firms can reach approval faster and with more resources.

Scope: Oncolytic virus and oncology markets
Materiality: high

medium

Regulatory and trial-enrollment risk

Approval timelines and patient recruitment can slow or stop development programs.

Scope: Global clinical studies
Materiality: medium

medium

Data security and privacy exposure

Clinical trial and patient data are sensitive and subject to privacy rules.

Scope: U.S. and EU operations
Materiality: medium

In-process R&D valuation

Can create large non-cash impairment charges

Goodwill impairment

Affects reported earnings and equity

Contingent consideration

Can introduce volatility in operating results

R&D expense recognition

Drives period-to-period operating loss volatility

Theriva Biologics, Inc.

Funding and going-concern pressure

Clinical development failure

Competitive displacement

Regulatory and trial-enrollment risk

Data security and privacy exposure

Innoviva, Inc.

TG THERAPEUTICS, INC.

Bone Biologics Corp

Unicycive Therapeutics, Inc.

Enliven Therapeutics, Inc.

ADMA BIOLOGICS, INC.