TOVX

Business Context and Reporting Period

Company: Theriva Biologics, Inc. (TOVX)
Filing Type: Form 10-K (Annual Report)
Period Ended: December 31, 2025
Business Overview: Theriva is a clinical-stage biopharmaceutical company focused on oncology following the 2022 acquisition of VCN Biosciences. Its lead product candidate is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus for treating solid tumors, specifically metastatic pancreatic ductal adenocarcinoma (mPDAC) and retinoblastoma. The company also holds assets in gastrointestinal (GI) diseases (SYN-004 and SYN-020), though it is actively seeking partners for these programs to focus capital on oncology.

Key Financial Metrics

Note: The increase in G&A expenses in 2025 was primarily driven by a $9.0 million adjustment to contingent consideration following the achievement of clinical milestones.

Material Changes vs. Prior Period

• Clinical Milestone Achievement: The VIRAGE Phase 2b clinical trial for VCN-01 in mPDAC met its primary endpoints for overall survival and safety. This triggered a $6.0 million milestone payment obligation to Grifols (partially deferred) and a $9.0 million fair value adjustment to contingent consideration, significantly impacting 2025 operating expenses.
• Workforce Reduction: In September 2025, the company implemented a workforce reduction of seven employees (32% of the global workforce) to extend its cash runway, incurring approximately $520,000 in charges.
• Capital Raises: The company raised approximately $6.8 million via its At-The-Market (ATM) facility and $3.9 million net from a warrant inducement exercise in 2025.
• Asset Licensing: In February 2026 (subsequent event), the company licensed its SYN-020 asset to Rasayana Therapeutics for a $300,000 upfront payment, shifting development costs to the partner.

Guidance, Outlook, and Risks

Outlook and Liquidity: Management expects current cash resources (approximately $15.1 million as of early March 2026) to fund operations into the first quarter of 2027. This runway is sufficient for overhead, closing the VIRAGE trial, regulatory interactions, and exploratory manufacturing scale-up. However, it is not sufficient to fund a Phase 3 clinical trial or complete the final cohort of the SYN-004 trial without additional capital.

Going Concern: The independent auditor has issued a report containing an explanatory paragraph regarding the company's ability to continue as a going concern due to recurring losses and an accumulated deficit. The company's ability to continue is dependent on raising additional capital.

Key Risks:

• Capital Requirements: Failure to secure additional funding could force the company to delay, reduce, or eliminate development programs.
• Deferred Milestone Payment: A $5.0 million portion of the Grifols milestone payment remains deferred pending discussions; payment of this amount would significantly deplete liquidity.
• Regulatory and Clinical: Success depends on FDA/EMA approvals for VCN-01. Clinical trials are expensive and subject to failure.
• Government Shutdowns: Recent U.S. federal government shutdowns have delayed regulatory reviews and SEC filings, creating uncertainty.

Investor Verification Checklist

• Cash Runway Validation: Verify if the projected cash runway into Q1 2027 holds given the potential need to pay the deferred $5.0 million Grifols milestone.
• Phase 3 Feasibility: Assess the likelihood of securing a partner or financing for a pivotal Phase 3 trial, as internal funds are insufficient.
• SYN-004 Strategy: Confirm the status of out-licensing or partnering efforts for the SYN-004 asset, as internal development is paused due to funding constraints.
• Regulatory Timeline: Monitor the impact of government shutdowns on the planned End-of-Phase 2 meeting with the FDA scheduled for the first half of 2026.
• Stock Liquidity: Review NYSE American listing compliance, specifically regarding minimum stockholders' equity and share price requirements, given the company's history of reverse stock splits.