TOVX

Business Context and Reporting Period

Company: Theriva Biologics, Inc. (TOVX)
Filing Type: Form 8-K (Current Report)
Date of Report: May 27, 2025
Event: Regulation FD Disclosure and Other Events regarding the presentation of Phase 1 clinical trial results for VCN-01 at the 2025 American Society of Clinical Oncology (ASCO) annual meeting.

Key Financial Metrics

This filing is a current report regarding clinical trial results and does not contain financial statements. The filing text does not provide clear values for revenue, profit, cash flow, margins, debt, or liquidity.

Material Changes

There are no financial material changes reported in this filing. The material event is the disclosure of clinical data for the investigational oncolytic virus VCN-01 in refractory retinoblastoma patients.

Outlook, Management Commentary, and Clinical Results

Clinical Study Overview: An investigator-sponsored Phase 1 dose-escalation study presented by Dr. Jaume Català-Mora.
Safety Profile:

• VCN-01 was well tolerated after intravitreal administration at two doses.
• No dose-limiting toxicities were observed.
• No ocular or systemic toxicities equal to or greater than Grade 3 occurred.
• Most frequent adverse events were Grade 1 or 2 uveitis; no retinal toxicity was caused.
• Ocular inflammation and turbidity were managed with anti-inflammatory drugs.

Efficacy and Mechanism:

• Selective replication of VCN-01 was observed in retinoblastoma cells but not in healthy tissue.
• Retinal function was not altered by the treatment.
• Four patients showed unequivocal improvement in vitreous seed density.
• Eye enucleation was avoided in 3 patients; one patient retained their eye after 4 years of follow-up.

Regulatory Note: The information furnished in Item 7.01 is not deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 and shall not be incorporated by reference into other filings.

Investor Verification Checklist

• Verify the full text of the poster presentation filed as Exhibit 99.1 for detailed patient data.
• Confirm the timeline for potential Phase 2 trials or regulatory filings based on these Phase 1 results.
• Review the company's most recent 10-K or 10-Q for current cash runway and funding status, as this 8-K contains no financial data.
• Monitor for any updates on the management of Grade 1 or 2 uveitis in future patient cohorts.