Theriva Biologics narrows Q3 2026 net loss to $1.47M
Quarter-end cash was $8.473 million, and Theriva described its cash runway as extending into Q1 2027.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Theriva Biologics, Inc. reported a net loss attributable to common stockholders of $1.471 million for the quarter ended September 30, 2026, compared with $4.361 million a year earlier. Nine-month license revenue was $300,000. General and administrative expense decreased 51% to $923,000, and research and development expense decreased 76% to $612,000. Cash and cash equivalents were $8.473 million as of September 30, 2026, with cash runway into Q1 2027.
In October 2026, Theriva completed the sale of SYN-004 (ribaxamase) and its related portfolio of antibiotic-degrading enzymes to Biossil Labs Inc. for $350,000 upfront, up to $91 million in aggregate milestones, and royalties. Detailed analyses of the VIRAGE Phase 2b trial data were published in Nature Medicine.
For VIRAGE2, a Phase 2a study of more frequent, longer-duration VCN-01 dosing in metastatic pancreatic ductal adenocarcinoma, enrollment is expected to complete in Q4 2026; initial pharmacodynamic and safety/tolerability data are expected by Q3 2027. The trial is expected to enroll 6 evaluable patients.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major point. Forward-looking: it has not happened yet and may not happen.SYN-004 sale: $350,000 upfront, up to $91 million in aggregate milestones, and royalties. 4.7% of market cap
- Moderate pointQuarterly net loss narrowed to $1.471 million from $4.361 million.
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Cash runway extends into Q1 2027.
Filing Explained
At September 30, 2026, Theriva reported 45,892,668 common shares outstanding, versus 35,688,350 at December 31, 2025; with their own holdings unchanged, existing holders therefore owned a smaller fraction of the company.
8-K Event Classification
Key Figures
Key Terms
contingent consideration financial
oncolytic adenovirus technical
pharmacodynamic medical
vitreous seeds medical
Earnings Snapshot
Cash runway into Q1 2027; VIRAGE2 enrollment expected to complete in Q4 2026, with initial pharmacodynamic and safety/tolerability data expected by Q3 2027.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What was TOVX’s net loss in Q3 2026?
How much were the proceeds and milestones from TOVX’s SYN-004 sale?
When are TOVX’s VIRAGE2 enrollment and initial data expected?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported):
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(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | ||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | ||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | ||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | ||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name
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Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results of Operations and Financial Condition.
On November 12, 2026, Theriva Biologics, Inc., a Nevada corporation (the “Company”), issued a press release that included financial information for its quarter ended September 30, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current 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 November 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: November 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 Third Quarter 2026 Operational Highlights and Financial Results
– VIRAGE2 enrollment expected to complete in Q4 2026; initial data expected by Q3 2027 –
– Company completes sale of SYN-004 (ribaxamase) and related portfolio of antibiotic-degrading enzymes to Biossil Labs Inc. in October, 2026 for $350,000 upfront and up to $91 million in aggregate milestones as well as royalties –
– Detailed analyses of data from the VIRAGE Phase 2b clinical trial published in Nature Medicine –
– Cash and cash equivalents of $8.5 million as of September 30, 2026; cash runway into Q1 2027 –
Rockville, Md., November 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 third quarter ended September 30, 2026, and provided a corporate update.
“We are pleased with the clinical progress achieved this quarter,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Patient enrollment and dosing in the VIRAGE2 trial is progressing well, and we anticipate completing enrollment by the end of the fourth quarter of this year. The VIRAGE2 trial is a crucial step in the clinical advancement of VCN-01 as we evaluate a dosing regimen that is intended to maximize its potential clinical benefit in different cancer therapy combinations. The publication of detailed analyses of the results from the VIRAGE study in Nature Medicine was a gratifying validation of VCN-01’s novel mode of action and therapeutic potential in metastatic pancreatic ductal adenocarcinoma (PDAC). The recently signed asset sale agreement for SYN-004 (ribaxamase) and the related portfolio of antibiotic-degrading enzymes to Biossil Labs Inc. demonstrates our commitment to deriving value from our legacy microbiome programs while continuing to focus on the development of our lead program VCN-01. In parallel, we continue to evaluate strategic alternatives intended to maximize value for our stockholders.”
Recent Highlights and Anticipated Milestones
VCN-01
Metastatic PDAC:
| · | Two thirds of the target number of patients (4) have been dosed and enrollment is ongoing in the VIRAGE2 Phase 2a clinical trial evaluating the feasibility of more frequent repeated dosing of VCN-01 in combination with standard-of-care chemotherapy in first-line metastatic PDAC patients (EUCT: 2026-525566-21-00; NCT07701486). |
| o | The VIRAGE2 trial builds on feedback from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recognizing improved survival outcomes in the VIRAGE2 trial in metastatic PDAC patients receiving 2 doses of VCN-01 administered 3-months apart. |
| o | The VIRAGE2 trial is designed to evaluate the safety and feasibility of administering at least 3 doses of VCN-01 given approximately 2 months apart in combination with standard-of-care chemotherapy. The trial is expected to enroll 6 evaluable patients. |
| o | VIRAGE2 is expected to complete enrollment in Q4 2026, with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027. |
| o | Results from the VIRAGE2 study, if successful, are expected to inform the VCN-01 dosing regimen for future clinical trials evaluating VCN-01 in different cancer therapy combinations, including a potential pivotal Phase 3 clinical trial in metastatic PDAC. |
| · | The detailed analyses of results from the VIRAGE Phase 2b trial evaluating VCN-01 in combination with gemcitabine/nab-paclitaxel standard-of-care chemotherapy in metastatic PDAC were recently published in Nature Medicine. The article is entitled “Intravenous hyaluronidase-expressing oncolytic adenovirus with chemotherapy in metastatic pancreatic cancer: a randomised phase 2b trial” and can be read here. |
| o | The published analyses of data from the VIRAGE trial highlighted that repeated dosing of VCN-01 in combination with gemcitabine/nab-paclitaxel chemotherapy was well-tolerated, with improved overall survival, progression-free survival and duration of response compared with chemotherapy alone. |
| o | Improved survival outcomes were observed in patients treated with two doses of VCN-01 (given 3 months apart) without increased toxicity, providing the rationale for evaluating more frequent administration of additional VCN-01 doses in the VIRAGE2 trial. |
| o | Data from the published analyses are consistent with the immune-mediated mechanism of action for VCN-01 that may enhance the anti-tumor effects of a range of coadministered pancreatic cancer therapies. |
Retinoblastoma:
| · | Discussions with key opinion leaders and the FDA are on-going regarding the design of a proposed Phase 2/3 clinical trial of intravitreal VCN-01 in combination with intravitreal topotecan in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy. |
| o | The proposed protocol builds on compelling Phase 1 clinical data in this ultra rare pediatric population for which there is no current treatment. |
| o | A Type C meeting completed with the FDA on August 31, 2026, provided guidance on the FDA’s current expectations for a clinical trial in this patient population, including proposed endpoints and statistical considerations. The FDA encouraged further discussion of the trial design with them, and additional interactions with the FDA are anticipated in Q1 2027. |
| o | VCN-01 has Orphan Drug Designation from the FDA, Orphan Medicinal Product Designation from the EMA and Rare Pediatric Disease Designation from the FDA for the treatment of retinoblastoma; if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, the Company may be eligible to receive a Priority Review Voucher. |
SYN-004
| · | Theriva completed the sale of Theriva’s portfolio of antibiotic-degrading enzymes, including SYN-004 (ribaxamase), SYN-007 (reformulated ribaxamase), and SYN-006 (carbapenemase), pursuant to an asset sale agreement with Biossil Labs Inc. (“Biossil”). |
| o | Biossil acquired all rights, title and interest in SYN-004, SYN-007 and SYN-006, and assumed all responsibility and costs for development and commercialization of the assets. |
| o | Under the terms of the agreement, the Company received a $350,000 upfront payment upon closing and is eligible for an aggregate of up to $3 million in regulatory milestones and up to $88 million in sales milestones, as well as single-digit royalties on net product sales (capped at $250 million). |
| o | Concurrent with the Biossil asset sale, Theriva amended its Asset Purchase Agreement with PREV ABR LLC (from 2012) under which the Company originally acquired SYN-004 (ribaxamase) and the related product portfolio. Per the terms of the amendment, Theriva paid PREV ABR $140,000 upon receipt of the $350,000, and will be required to pay PREV 50% of future regulatory and sales milestone payments, 33⅓% of royalty payments received by Theriva, and 50% of other consideration received by Theriva in relation to the transferred assets, up to an aggregated total of $13 million. |
Third Quarter Ended September 30, 2026 Financial Results
General and Administrative Expenses
General and administrative expenses decreased to $923,000 for the three months ended September 30, 2026, from $1.9 million for the three months ended September 30, 2025. This decrease of 51% primarily reflects a $841,000 decrease in the fair value of contingent consideration recognized in the three months ended September 30, 2026, compared to a $633,000 increase recognized in the same period in 2025, partially offset by a current year increase in legal fees. The charge related to stock-based compensation expense was $119,000 for the three months ended September 30, 2026, compared to $118,000 for the three months ended September 30, 2025.
Research and Development Expenses
Research and development expenses decreased to $612,000 for the three months ended September 30, 2026, from approximately $2.6 million for the three months ended September 30, 2025. This decrease of 76% is primarily the result of lower direct expenses related to the completion of the VCN-01 Phase 2b PDAC clinical trial, lower direct expenses related to VCN-01 manufacturing activities, lower direct clinical trial expenses related to the paused Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, lower expenses related to SYN-020, partially offset by expenses associated with the conduct of the VIRAGE2 Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period.
Other Income/Expense
Other income was $64,000 for the three months ended September 30, 2026, compared to other income of $79,000 for the three months ended September 30, 2025. Other income for the three months ended September 30, 2026 is comprised of interest income of $64,000. Other income for the three months ended September 30, 2025 is primarily comprised of interest income of $65,000 and an exchange gain of $14,000.
Cash and Cash Equivalents
Cash and cash equivalents totaled $8.5 million as of September 30, 2026, a decrease of $4.6 million from December 31, 2025. During the year ended December 31, 2025, and nine months ended September 30, 2026, the primary use of cash was for working capital requirements and operating activities, which resulted in a net loss of $23.7 million and $6.7 million for the year ended December 31, 2025, and the nine months ended September 30, 2026, respectively.
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 intratumoral 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 candidate is VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment. 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 regarding VIRAGE2 completing enrollment in Q4 2026, with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027; the VIRAGE2 trial being expected to enroll 6 evaluable patients; the results from the VIRAGE2 trial informing the VCN-01 dosing regimen for future clinical trials evaluating VCN-01 in different cancer therapy combinations, including a potential pivotal Phase 3 clinical trial in metastatic PDAC; the proposed Phase 2/3 clinical trial of intravitreal VCN-01 in combination with intravitreal topotecan in children with retinoblastoma with vitreous seeds that are refractory/resistant to the use of current intravitreal chemotherapy; continuing to evaluate strategic alternatives intended to maximize value for our stockholders; the potential payment from Biossil of up to $91 million in aggregate milestones as well as royalties on net product sales (capped at $250 million); the Company having a cash runway into Q1 2027; publication of detailed analyses of the results from the VIRAGE study in Nature Medicine providing a validation of VCN-01’s novel mode of action and therapeutic potential in metastatic pancreatic ductal adenocarcinoma (PDAC); the Company being eligible to receive a Priority Review Voucher if a Biologics License Application (BLA) for VCN-01 for the treatment of retinoblastoma is approved by the FDA by September 30, 2029, and additional discussions of the retinoblastoma clinical development plan with the FDA anticipated in Q1 2027. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to finalize protocols for future clinical trials evaluating VCN-01; results of future trials supporting further clinical development of VCN-01 and supporting the benefits of more frequent repeated dosing of VCN-01; the Company’s ability to obtain development funding and/or partnerships; the Company’s ability to receive any milestone or royalty payments from Biossil, the Company’s commencement of planned clinical trials, which remains subject to sufficient financing; the Company’s ability to raise capital and/or enter into one or more strategic alternatives, that may include a business combination, merger or reverse merger; the Company’s ability to reach clinical milestones when anticipated, including the ability to continue to enroll patients as planned; generating clinical data that establishes VCN-01 may improve patient outcomes in cancer patients; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, including approval of VCN-01 to treat cancer patients; regulatory limitations relating to the Company’s ability to promote or commercialize its product candidates for the specific indications; acceptance of the Company’s product candidates in the marketplace; 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 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, 2025 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 Biologics 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
Condensed Consolidated Balance Sheets
(In thousands except share and par value amounts)
| September 30, 2026 | December 31, 2025 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 8,473 | $ | 13,056 | ||||
| Tax credit receivable | 1,673 | 3,351 | ||||||
| Prepaid expenses and other current assets | 475 | 1,060 | ||||||
| Total Current Assets | 10,621 | 17,467 | ||||||
| Non-Current Assets | ||||||||
| Property and equipment, net | 155 | 222 | ||||||
| Restricted cash | 44 | 46 | ||||||
| Right of use asset | 1,704 | 803 | ||||||
| In-process research and development | 18,956 | 19,619 | ||||||
| Deposits and other assets | 80 | 82 | ||||||
| Total Assets | $ | 31,560 | $ | 38,239 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 467 | $ | 1,014 | ||||
| Accrued expenses | 6,459 | 6,276 | ||||||
| Accrued employee benefits | 284 | 443 | ||||||
| Deferred research and development tax credit-current portion | 995 | 1,675 | ||||||
| Loans payable-current | 34 | 57 | ||||||
| Operating lease liability-current portion | 540 | 549 | ||||||
| Total Current Liabilities | 8,779 | 10,014 | ||||||
| Non-current Liabilities | ||||||||
| Non-current contingent consideration | 8,978 | 10,004 | ||||||
| Loan Payable - non-current | 1,627 | 1,671 | ||||||
| Non-current deferred research and development tax credit | 197 | 815 | ||||||
| Non-current operating lease liability | 1,226 | 352 | ||||||
| Total Liabilities | 20,807 | 22,856 | ||||||
| Commitments and Contingencies (Note 14) | — | — | ||||||
| Stockholders’ Equity: | ||||||||
| Common stock, $0.001 par value; 350,000,000 shares authorized, 45,921,478 issued and 45,892,668 outstanding at September 30, 2026 and 35,717,159 issued and 35,688,350 outstanding at December 31, 2025 | 45 | 34 | ||||||
| Additional paid-in capital | 376,298 | 373,592 | ||||||
| Treasury stock at cost, 28,810 shares at September 30, 2026 and at December 31, 2025 | (288 | ) | (288 | ) | ||||
| Accumulated other comprehensive income | 140 | 755 | ||||||
| Accumulated deficit | (365,442 | ) | (358,710 | ) | ||||
| Total Stockholders’ Equity | 10,753 | 15,383 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 31,560 | $ | 38,239 | ||||
Theriva Biologics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| License Revenue | $ | — | $ | — | $ | 300 | $ | — | ||||||||
| Operating Costs and Expenses: | ||||||||||||||||
| General and administrative | 923 | 1,889 | 5,025 | 14,516 | ||||||||||||
| Research and development | 612 | 2,551 | 2,234 | 7,472 | ||||||||||||
| Total Operating Costs and Expenses | 1,535 | 4,440 | 7,259 | 21,988 | ||||||||||||
| Loss from Operations | (1,535 | ) | (4,440 | ) | (6,959 | ) | (21,988 | ) | ||||||||
| Other Income/Expense: | ||||||||||||||||
| Foreign currency exchange gain | — | 14 | 1 | 30 | ||||||||||||
| Interest income | 64 | 65 | 226 | 215 | ||||||||||||
| Total Other Income | 64 | 79 | 227 | 245 | ||||||||||||
| Net Loss before income taxes | (1,471 | ) | (4,361 | ) | (6,732 | ) | (21,743 | ) | ||||||||
| Income tax benefit | — | — | — | — | ||||||||||||
| Net Loss Attributable to Common Stockholders | $ | (1,471 | ) | $ | (4,361 | ) | $ | (6,732 | ) | $ | (21,743 | ) | ||||
| Net Loss Per Share - Basic and Dilutive | $ | (0.03 | ) | $ | (0.45 | ) | $ | (0.15 | ) | $ | (3.38 | ) | ||||
| Weighted average number of shares outstanding during the period - Basic and Dilutive | 45,892,668 | 9,676,521 | 44,303,676 | 6,429,227 | ||||||||||||
| Net Loss | (1,471 | ) | (4,361 | ) | (6,732 | ) | (21,743 | ) | ||||||||
| (Loss) gain on foreign currency translation | (107 | ) | (30 | ) | (615 | ) | 1,941 | |||||||||
| Total comprehensive loss | $ | (1,578 | ) | $ | (4,391 | ) | $ | (7,347 | ) | $ | (19,802 | ) | ||||