Theriva™ Biologics Reports Full-Year 2025 Operational Highlights and Financial Results
Rhea-AI Summary
Theriva Biologics (NYSE: TOVX) reported full-year 2025 results and a corporate update on March 12, 2026. Key items: VCN-01 advancing toward pivotal PDAC Phase 3 after positive EMA scientific advice; SYN-020 licensed to Rasayana with up to $38 million in milestones plus royalties; cash of $13.1M at year-end and ~$15.2M as of Feb 26, 2026, funding operations into Q1 2027.
Positive
- Licensed SYN-020 to Rasayana with $300K upfront and up to $38M in milestone payments plus royalties
- EMA provided positive scientific advice supporting proposed Phase 3 VCN-01 design in metastatic PDAC
- VIRAGE Phase 2b achieved primary survival and safety endpoints, triggering a $9.0M contingent consideration adjustment
- Cash increased to approximately $15.2M as of Feb 26, 2026, extending runway into Q1 2027
Negative
- Independent auditor included an explanatory paragraph on the company’s ability to continue as a going concern
- General and administrative expenses rose 109% to $15.4M for 2025, driven by a $9.0M contingent consideration charge
- Research and development expenses declined 28% to $8.6M, reflecting lower trial activity and workforce reductions
News Market Reaction – TOVX
In the Mar 12 session, TOVX gained 1.23%, reflecting a mild positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 12 | Q3 2025 earnings | Positive | +8.1% | Q3 2025 results with expanded VIRAGE data and extended cash runway. |
| Aug 11 | Q2 2025 earnings | Positive | +14.0% | Q2 2025 results plus positive VIRAGE topline and retinoblastoma data. |
| May 14 | Q1 2025 earnings | Positive | +1.3% | Q1 2025 results, VIRAGE success, and $7.5M offering extending runway. |
| Mar 06 | FY 2024 earnings | Positive | -4.2% | Full-year 2024 results with VIRAGE enrollment completion and cash of $11.6M. |
| Nov 12 | Q3 2024 earnings | Negative | -23.1% | Q3 2024 results featuring high G&A, R&D decline and impairment charge. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Earnings-related releases have often been received positively, with 4 of the last 5 showing aligned price moves despite mixed financial details.
Over the last year, Theriva Biologics used earnings updates to pair financials with progress on VCN-01 and cash runway visibility. Prior reports on Mar 6, 2025 and May 14, 2025 highlighted advancing VIRAGE data and cash positions around $11.6M–$14.1M. Later quarters on Aug 11 and Nov 12, 2025 showed stronger clinical readouts and improved liquidity, which typically coincided with positive price reactions, framing today’s full-year 2025 update as a continuation of that narrative.
Key Terms
pancreatic ductal adenocarcinoma medical
retinoblastoma medical
orphan drug regulatory
rare pediatric disease regulatory
oncolytic virus medical
overall survival medical
progression free survival medical
duration of response medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Advancing clinical development of VCN-01 for pancreatic ductal adenocarcinoma and retinoblastoma -
- Licensed SYN-020 to Rasayana Therapeutics for development in multiple indications; up to
- Cash and cash equivalents of
ROCKVILLE, M.D., March 12, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the full year ended December 31, 2025, and provided a corporate update.
“We are very pleased to have completed the licensing of our versatile Phase 2-ready asset SYN-020 to Rasayana Therapeutics, executing on our plan to derive value from our GI portfolio while we remain focused on the advancement of our oncology pipeline,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “We continue to advance our lead oncolytic virus candidate VCN-01 towards pivotal clinical development in multiple indications of high unmet need. With the recent feedback from the EMA, we have further clarity on dosing regimen, protocol and overall design for our proposed Phase 3 trial in pancreatic ductal adenocarcinoma (PDAC). An End-of-Phase 2 meeting with the FDA is planned for the first half of 2026 to finalize our design for a multinational pivotal Phase 3 trial in PDAC, aiming to provide patients with a novel therapy for this difficult to treat solid tumor that has a high mortality rate. Additional interactions with the FDA and EMA are planned for 2026 to refine the design of a potential Phase 2/3 trial for retinoblastoma, for which VCN-01 has received Orphan Drug and Rare Pediatric Disease designation. We continue to engage in potential partnership discussions for the additional innovative drug candidates in our portfolio.”
Recent Highlights and Anticipated Milestones
VCN-01
Metastatic Pancreatic Ductal Adenocarcinoma (PDAC):
- As recently announced, Theriva received positive scientific advice from the EMA on the design of a Phase 3 trial in PDAC. The EMA provided overall agreement with the proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC, including sample size, repeated dosing of VCN-01, and an adaptive design to potentially optimize trial timelines and outcomes. Specific advice included agreement on proposed inclusion/exclusion criteria, primary endpoint (overall survival), secondary endpoints (including progression free survival, duration of response, and patient reported outcomes).
- An End-of-Phase 2 meeting with the FDA is planned for 1H 2026, aiming to finalize the design of a pivotal multinational Phase 3 clinical trial in PDAC.
- Additional analysis from the VIRAGE Phase 2b study has been accepted for a poster presentation at the American Association of Cancer Research (AACR) meeting in San Diego, CA, April 17-22, 2026.
Retinoblastoma:
- Further discussions are planned with both the FDA and EMA in 2026 to align on the protocol design, including target population and endpoints, for a Phase 2/3 trial in retinoblastoma, an indication for which VCN-01 has been granted Orphan Drug and Rare Pediatric Disease designation.
- Safety and clinical outcomes from the Phase 1 study of VCN-01 in refractory retinoblastoma patients were recently presented at the 41st Asia-Pacific Academy of Ophthalmology (APAO) Congress.
SYN-020
- On February 18, 2026, Theriva announced that it granted Rasayana Therapeutics, Inc. an exclusive, worldwide license, with the right to sublicense, to develop and commercialize SYN-020 (recombinant bovine intestinal alkaline phosphatase) for therapeutic and diagnostic use. Theriva received a
$300,000 up-front payment at signing and is eligible for up to$16M in development and regulatory milestones, tiered single digit royalties on net product sales, and up to$22M in milestones payable upon achievement of certain annual aggregate net sales. - SYN-020 was well tolerated in Phase 1 clinical studies and is now poised to enter Phase 2 clinical testing. Rasayana will assume responsibility and costs for future clinical development and commercialization.
Full-Year Ended December 31, 2025 Financial Results
General and administrative expenses increased to
Research and development expenses decreased to
Cash and cash equivalents totaled
The audited financial statements for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K contain an audit opinion from the Company’s independent registered public accounting firm that includes an explanatory paragraph related to the Company’s ability to continue as a going concern.
About VCN-01
VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including pancreatic ductal adenocarcinoma (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.
About SYN-020
SYN-020 is a recombinant bovine intestinal alkaline phosphatase (IAP) produced under cGMP conditions and formulated for oral delivery to the small intestine. SYN-020 is designed to reduce fat absorption and intestinal inflammation, tighten the gut barrier to mitigate leaky gut, and promote a healthy microbiome. These complementary modes of action mean SYN-020 has the potential to address multiple metabolic and inflammatory disorders and diseases associated with aging. Despite its broad therapeutic potential, a key hurdle to commercialization has been the high cost of IAP manufacture. Theriva has overcome this hurdle and has developed a process to produce SYN-020 at a scale and cost viable for clinical and commercial development. In February 2026, Theriva granted to Rasayana Therapeutics, Inc. an exclusive, worldwide license, with the right to sublicense, to develop and commercialize SYN-020 (recombinant bovine intestinal alkaline phosphatase) for therapeutic and diagnostic use.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company’s subsidiary Theriva Biologics, S.L. , has been developing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead clinical-stage candidates is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. An exploratory clinical trial is also on-going with SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. For more information, please visit Theriva Biologics’ website at www.therivabio.com.
Forward-Looking Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements such as the Company receiving up to
For further information, please contact:
Investor Relations
Kevin Gardner
LifeSci Advisors, LLC
| Theriva Biologics, Inc. and Subsidiaries | ||||||||||||||
| Consolidated Balance Sheets | ||||||||||||||
| (In thousands except share and par value amounts) | ||||||||||||||
| December 31, | December 31, | |||||||||||||
| 2025 | 2024 | |||||||||||||
| Assets | ||||||||||||||
| Current Assets | ||||||||||||||
| Cash and cash equivalents | $ | 13,056 | $ | 11,609 | ||||||||||
| Tax credit receivable | 3,351 | 3,228 | ||||||||||||
| Prepaid expenses and other current assets | 1,060 | 1,444 | ||||||||||||
| Total Current Assets | 17,467 | 16,281 | ||||||||||||
| Non-Current Assets | ||||||||||||||
| Property and equipment, net | 222 | 270 | ||||||||||||
| Restricted cash | 46 | 96 | ||||||||||||
| Right of use asset | 803 | 1,272 | ||||||||||||
| In-process research and development | 19,619 | 17,358 | ||||||||||||
| Deposits and other assets | 82 | 75 | ||||||||||||
| Total Assets | $ | 38,239 | $ | 35,352 | ||||||||||
| Liabilities and Stockholders’ Equity | ||||||||||||||
| Current Liabilities: | ||||||||||||||
| Accounts payable | $ | 1,014 | $ | 859 | ||||||||||
| Accrued expenses | 6,276 | 3,368 | ||||||||||||
| Accrued employee benefits | 443 | 1,144 | ||||||||||||
| Deferred research and development tax credit-current portion | 1,675 | 1,614 | ||||||||||||
| Loans payable-current | 57 | 61 | ||||||||||||
| Operating lease liability-current portion | 549 | 539 | ||||||||||||
| Total Current Liabilities | 10,014 | 7,585 | ||||||||||||
| Non-current Liabilities | ||||||||||||||
| Non-current contingent consideration | 10,004 | 6,973 | ||||||||||||
| Loan Payable - non-current | 1,671 | 92 | ||||||||||||
| Non-current deferred research and development tax credit | 815 | 762 | ||||||||||||
| Non-current operating lease liability | 352 | 873 | ||||||||||||
| Total Liabilities | 22,856 | 16,285 | ||||||||||||
| Commitments and Contingencies (Note 12) | — | — | ||||||||||||
| Stockholders’ Equity: | ||||||||||||||
| Common stock, | 34 | 3 | ||||||||||||
| Additional paid-in capital | 373,592 | 355,501 | ||||||||||||
| Treasury stock at cost, 28,809 shares at December 31, 2025 and at December 31, 2024 | (288 | ) | (288 | ) | ||||||||||
| Accumulated other comprehensive income (loss) | 755 | (1,178 | ) | |||||||||||
| Accumulated deficit | (358,710 | ) | (334,971 | ) | ||||||||||
| Total Stockholders‘ Equity | 15,383 | 19,067 | ||||||||||||
| Total Liabilities and Stockholders’ Equity | $ | 38,239 | $ | 35,352 | ||||||||||
| Theriva Biologics, Inc. and Subsidiaries | |||||||
| Consolidated Statements of Operations and Comprehensive Loss | |||||||
| (In thousands, except share and per share amounts) | |||||||
| For the year ended | |||||||
| December 31, | |||||||
| 2025 | 2024 | ||||||
| Operating Costs and Expenses: | |||||||
| General and administrative | $ | 15,447 | $ | 7,396 | |||
| Research and development | 8,604 | 12,031 | |||||
| In-process research and development impairment | — | 1,325 | |||||
| Goodwill impairment | — | 5,594 | |||||
| Total Operating Costs and Expenses | 24,051 | 26,346 | |||||
| Loss from Operations | (24,051 | ) | (26,346 | ) | |||
| Other Income: | |||||||
| Foreign currency exchange gain (loss) | 25 | (4 | ) | ||||
| Interest income | 287 | 697 | |||||
| Total Other Income | 312 | 693 | |||||
| Net Loss before income taxes | (23,739 | ) | (25,653 | ) | |||
| Income tax benefit | — | — | |||||
| Net loss | $ | (23,739 | ) | $ | (25,653 | ) | |
| Less deemed dividend from warrant inducement | (1,510 | ) | — | ||||
| Net Loss Attributable to Common Stockholders | $ | (25,249 | ) | $ | (25,653 | ) | |
| Net Loss Per Share - Basic and Dilutive | $ | (2.08 | ) | $ | (19.03 | ) | |
| Weighted average number of shares outstanding during the period - basic and dilutive | 12,140,697 | 1,348,126 | |||||
| Net Loss | (23,739 | ) | (25,653 | ) | |||
| Gain (loss) on foreign currency translation | 1,933 | (1,210 | ) | ||||
| Total comprehensive loss | $ | (21,806 | ) | $ | (26,863 | ) | |
