aibioTheriva Biologics files to sell up to $2,534,352 of stock through at-the-market program
Tickers TOVX
Theriva Biologics filed to sell up to $2,534,352 of stock through A.G.P./Alliance Global Partners, under a cap set by its public float. Its auditor's report carries a going-concern paragraph, and the main survival result in its lead trial has a p-value of 0.0546.
Key facts
- Company
- Theriva Biologics, Inc. (AMEX: TOVX)
- News type
- Financings
- Primary source
- Theriva Biologics, Inc. 424B5 (2025-06-20)
The program
Theriva Biologics, Inc. filed a prospectus supplement on June 20, 2025 for up to $2,534,352 of common stock. The shares would be sold through A.G.P./Alliance Global Partners under an at-the-market sales agreement dated February 9, 2021, amended in 2021 and again on May 2, 2024. The agent will use commercially reasonable efforts and earns a commission of up to 3.0% of the gross sales price of each share sold.
The cap and recent sales
The amount is limited by General Instruction I.B.6 of Form S-3. The company puts its non-affiliate public float at approximately $12,940,401.76, based on 9,049,241 shares at $1.43, the highest closing price on the NYSE American within the prior 60 days, on April 23, 2025. In the twelve months before the supplement, it had already sold about $1,779,115 of stock under that rule.
From the start of 2024 through the date of the supplement, Theriva sold about 569,000 shares under the agreement for net proceeds of about $3.6 million. The last reported sale price on June 17, 2025 was $0.465 a share on the NYSE American.
The company and its trial
Theriva describes itself as a diversified clinical-stage company developing cancer therapies. Its lead candidate, VCN-01, is an oncolytic adenovirus with Orphan Drug and Fast Track designations for pancreatic cancer. The Phase 2b VIRAGE trial combines it with gemcitabine and nab-paclitaxel as first-line treatment for metastatic pancreatic cancer.
The company announced positive topline outcomes on May 7, 2025. The analysis covers 96 newly diagnosed patients, 48 in each arm. Median overall survival, the primary endpoint, was 10.8 months with VCN-01 against 8.6 months with chemotherapy alone. The hazard ratio was 0.57, with a 95% confidence interval of 0.34 to 0.96 and a p-value of 0.0546, which is above the conventional 0.05 threshold. Progression-free survival was 7.0 months against 4.6 months (p-value 0.0105). Median duration of response was 11.2 months against 5.4 months.
A subgroup that received two VCN-01 doses and four or more cycles of chemotherapy had median survival of 14.8 months, against 11.6 months for patients with four or more cycles and no second dose. The company says the second dose provides a meaningful additional benefit in that subgroup, but the p-value of 0.046 comes from a trial whose primary survival result falls short of the conventional threshold.
A second data monitoring committee review in March 2025 found VCN-01 well tolerated with chemotherapy. The most common adverse events were pyrexia, flu-like illness, vomiting, nausea and elevated transaminases.
It is exploring out-licensing or partnering for its gastrointestinal assets SYN-004 and SYN-020.
Going concern and the May offering
The auditor's report on the consolidated financial statements contains an explanatory paragraph on the company's ability to continue as a going concern.
On May 8, 2025, the company closed a public offering of 1,990,900 shares, pre-funded warrants for up to 4,827,280 shares and common warrants for up to 6,818,180 shares. Each share with a common warrant sold for $1.10. Gross proceeds were about $7.5 million before placement agent fees and expenses. A.G.P. was placement agent on a reasonable best efforts basis for a fee of 7.0% of gross proceeds, plus up to $100,000 of expenses.
It did reverse stock splits of one-for-thirty-five in August 2018 and one-for-ten in July 2022.
Counsel, dilution and earlier raises
Blank Rome LLP of New York represents Theriva, and Parsons Behle & Latimer of Reno, Nevada will pass on the validity of the shares. Duane Morris LLP of New York is counsel to the sales agent.
The supplement assumes a sale of 5,450,219 shares at $0.465, the June 17, 2025 closing price. On that basis, new investors would face immediate dilution of $0.025 per share against pro forma net tangible book value of $0.446 per share at March 31, 2025. A.G.P. was also placement agent in a September 2024 offering that raised approximately $2.5 million, at the same 7.0% fee. The May 2025 units priced at $1.10, against the $0.465 last sale price cited here.