Theriva Biologics (NYSE: TOVX) details 2025 loss and cash runway into 2027
Rhea-AI Filing Summary
Theriva Biologics reported full-year 2025 results alongside a strategic licensing deal. The company licensed its Phase 2‑ready asset SYN-020 to Rasayana Therapeutics, with up to
Cash and cash equivalents were
The company recorded a 2025 net loss of
Positive
- None.
Negative
- Going concern uncertainty: The audited 2025 financial statements include an audit opinion with an explanatory paragraph about the company’s ability to continue as a going concern, highlighting reliance on future financing and successful execution of its development plans.
Insights
Theriva combines a licensing win and PDAC progress with continued losses and a going-concern flag.
Theriva Biologics shifted strategy in 2025, monetizing its GI portfolio by licensing SYN-020 to Rasayana for up to
Financially, Theriva posted a 2025 net loss of
Cash rose to
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02. | Results of Operations and Financial Condition. |
On March 12, 2026, Theriva Biologics, Inc., a Nevada corporation (the “Company”) issued a press release that included financial information for its fiscal year ended December 31, 2025. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit Number |
Description | |
| 99.1 | Press Release issued by Theriva Biologics, Inc., dated March 12, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: March 12, 2026 | THERIVA BIOLOGICS, INC. | ||
| By: | /s/ Steven A. Shallcross | ||
| Name: | Steven A. Shallcross | ||
| Title: | Chief Executive Officer and Chief Financial Officer | ||
Exhibit 99.1
Theriva™
Biologics Reports Full-Year 2025 Operational Highlights
and Financial Results
- 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 $38 million in potential milestones plus royalties on commercial sales -
- Cash and cash equivalents of $13.1 million as of December 31, 2025; recent capital raises increase cash to $15.2 million as of February 26, 2026 and provides cash runway into Q1 2027-
Rockville, MD, March 12, 2026 – 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 $15.4 million for the year ended December 31, 2025, from $7.4 million for the year ended December 31, 2024. This increase of 109% is primarily comprised of the contingent consideration adjustment of $9.0 million due to the VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in PDAC achieving its primary survival and safety endpoints, offset by a decrease in compensation costs, investor relations costs, consulting fees, and lower director and officer insurance. The charge relating to stock-based compensation expense was $379,000 for the year ended December 31, 2025, compared to $438,000 for the year ended December 31, 2024.
Research and development expenses decreased to $8.6 million for the year ended December 31, 2025, from $12.0 million for the year ended December 31, 2024. This decrease of 28% is primarily the result of lower clinical trial expenses related to the completion of our VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in PDAC, lower clinical trial expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and lower indirect cost related to compensation, offset by higher patent expenses related to SYN-020. We anticipate research and development expense to decrease in 2026 as a result of the workforce reduction plan that was implemented on September 30, 2025, the completion of our VIRAGE Phase 2b clinical trial of VCN-01 and our focus on regulatory interactions around potential pivotal clinical trials of VCN-01 in PDAC and retinoblastoma, the planning for VCN-01 manufacturing scale-up activities, a potential Phase 2a study evaluating VCN-01 dosing frequency, and continuing to support our other preclinical and discovery initiatives. In addition, pursuant to the terms of the Rasayana License Agreement that we entered into in February 2026, we will not continue to conduct research and development activities with respect to SYN-020, and do not expect to incur material expenditures in connection therewith since Rasayana is now responsible for all such expenditures including patent expenses. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $281,000 for the year ended December 31, 2025, compared to $233,000 for the year ended December 31, 2024.
Cash and cash equivalents totaled $13.1 million as of December 31, 2025, compared to $11.6 million as of December 31, 2024. The Company’s current cash of approximately $15.2 million at February 26, 2026 will allow it to fund operations into the first quarter of 2027, including overhead costs, close out of the VIRAGE Phase 2b clinical trial, a potential Phase 2a study evaluating VCN-01 dosing frequency, exploratory VCN-01 (zabilugene almadenorepvec) manufacturing scale-up activities, regulatory interactions regarding proposed VCN-01 clinical trials in PDAC and retinoblastoma, and preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program.
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 $38 million in potential milestones plus royalties on commercial sales; cash runway into Q1 2027; continuing to advance the Company’s lead oncolytic virus candidate VCN-01 towards pivotal clinical development in multiple indications of high unmet need; the planned End-of-Phase 2 meeting with the FDA for the first half of 2026 to finalize the Company’s 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; the planned additional interactions with the FDA and EMA for 2026 to refine the design of a potential Phase 2/3 trial for retinoblastoma; continuing to engage in potential partnership discussions for the additional innovative drug candidates in the Company’s portfolio; potentially optimizing PDAC Phase 3 trial timelines by the use of an adaptive design; the Company receiving 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 being now poised to enter Phase 2 clinical testing; Rasayana assuming responsibility and costs for future clinical development and commercialization; research and development expense anticipated to decrease in 2026; a potential Phase 2a study evaluating VCN-01 dosing frequency; continuing to support the Company’s other preclinical and discovery initiatives; and preclinical studies supporting VCN-01 and VCN-12, the first candidate from the Company’s VCN-X discovery program. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include among others, the Company’s product candidates, including VCN-01 and VCN-12, demonstrating safety and effectiveness in clinical indications, as well as results that are consistent with prior results; the ability to confirm VCN-12 preclinical data in the clinical setting; the Company’s ability to reach clinical milestones when anticipated including enrolling the expected number of patients in each trial; the Company’s ability to complete clinical trials on time and achieve the desired results and benefits; the Company’s ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for the specific indications; acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s products; developments by competitors that render such products obsolete or non-competitive; the Company’s ability to maintain license agreements; the continued maintenance and growth of the Company’s patent estate; the Company’s ability to continue to remain well financed; and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
For further information, please contact:
Investor Relations
Kevin Gardner
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com
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, $0.001 par value; 350,000,000 shares authorized, 35,717,159 issued and 35,688,350 outstanding at December 31, 2025 and 2,811,259 issued and 2,782,449 outstanding at December 31, 2024 | 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 | ) | ||
FAQ
What were Theriva Biologics (TOVX) full-year 2025 financial results?
How much cash does Theriva Biologics (TOVX) have and what is its runway?
What is included in Theriva Biologics’ SYN-020 license deal with Rasayana?
Did Theriva Biologics (TOVX) receive a going concern warning for 2025?
How did Theriva Biologics’ R&D and G&A expenses change in 2025?
What are Theriva Biologics’ key development plans for VCN-01?
Filing Exhibits & Attachments
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