Theriva™ Biologics Reports Third Quarter 2026 Operational Highlights and Financial Results
The expected cash runway extends into Q1 2027, while initial VIRAGE2 data are anticipated by Q3 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 Summary
Theriva Biologics (TOVX) reported a narrower third-quarter net loss as expenses fell and advanced enrollment in its VIRAGE2 cancer trial. Net loss was $1.471 million, or $0.03 per share, versus $4.361 million, or $0.45 per share, a year earlier. Cash was $8.5 million at September 30, 2026; the company expects its runway to extend into Q1 2027.
Four patients have received treatment in VIRAGE2, which targets six evaluable patients with metastatic pancreatic cancer. Theriva expects enrollment completion in Q4 2026 and initial data by Q3 2027. Published VIRAGE Phase 2b analyses showed improved survival with VCN-01 plus chemotherapy versus chemotherapy alone. In October, Theriva sold its antibiotic-degrading enzyme portfolio to Biossil Labs for $350,000 upfront, with eligibility for up to $91 million in milestones and single-digit royalties. Related payments to PREV ABR reduce Theriva’s retained proceeds.
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
- Moderate pointThird-quarter net loss narrowed to $1.471 million, or $0.03 per share, from $4.361 million, or $0.45.
- Moderate pointPublished VIRAGE Phase 2b analyses showed improved overall survival, progression-free survival and response duration versus chemotherapy alone.
- Moderate pointThe completed Biossil Labs asset sale delivered $350,000 upfront and transferred development and commercialization costs to Biossil. 4.7% of market cap
- Minor pointThird-quarter general and administrative expenses fell 51% to $923,000 from $1.889 million a year earlier.
- Minor pointThird-quarter research and development expenses fell 76% to $612,000 from $2.551 million a year earlier.
8 minor points
- Minor pointNine-month license revenue reached $300,000, versus none in the corresponding 2025 period.
- Minor pointNine-month net loss narrowed to $6.732 million, or $0.15 per share, from $21.743 million, or $3.38.
- Minor point. Forward-looking: it has not happened yet and may not happen.VIRAGE2 has dosed four patients; Theriva expects enrollment completion in Q4 2026 and initial data by Q3 2027.
- Minor pointVIRAGE patients receiving two VCN-01 doses three months apart had improved survival without increased toxicity.
- Minor point. Forward-looking: it has not happened yet and may not happen.Asset-sale consideration includes eligibility for up to $91 million in aggregate regulatory and sales milestones.
- Minor point. Forward-looking: it has not happened yet and may not happen.Asset-sale terms include single-digit royalties on net product sales, capped at $250 million.
- Minor point. Forward-looking: it has not happened yet and may not happen.Retinoblastoma development received FDA trial-design guidance; Theriva anticipates further FDA interactions in Q1 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.Retinoblastoma approval by September 30, 2029 may make Theriva eligible for a Priority Review Voucher.
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Cash declined to $8.5 million at September 30, 2026; Theriva expects runway only into Q1 2027.
- Moderate pointCommon shares outstanding increased to 45,892,668 at September 30, 2026, from 35,688,350 at December 31, 2025.
- Minor pointPREV ABR received $140,000 from Theriva following receipt of the asset-sale upfront payment.
- Minor point. Forward-looking: it has not happened yet and may not happen.PREV ABR receives 50% of future milestones and other consideration, plus 33⅓% of royalties, capped collectively at $13 million.
- Minor point. Forward-looking: it has not happened yet and may not happen.Future trial dosing depends on successful VIRAGE2 results; a pivotal Phase 3 trial remains potential.
3 minor points
- Minor point. Forward-looking: it has not happened yet and may not happen.The retinoblastoma Phase 2/3 trial remains proposed, with design discussions ongoing with the FDA.
- Minor pointThird-quarter other income declined to $64,000 from $79,000 a year earlier.
- Minor pointStockholders’ equity declined to $10.753 million at September 30, 2026, from $15.383 million at December 31, 2025.
News Explained
Outstanding common shares rose from 35,688,350 at December 31, 2025, to 45,892,668 at September 30, 2026, shrinking an unchanged holding’s ownership fraction.
After the completed sale in
The release reports
Key Figures
- Upfront asset-sale payment
- $350,000
- Received upon closing of the SYN-004 portfolio sale
- Regulatory milestones
- Up to $3 million
- Potential payments under the Biossil asset-sale agreement
- Sales milestones
- Up to $88 million
- Potential payments under the Biossil asset-sale agreement
- Royalties
- Single-digit royalties; capped at $250 million
- On net product sales under the Biossil asset-sale agreement
- Cash and cash equivalents
- $8.5 million
- As of September 30, 2026; cash runway into Q1 2027
- VIRAGE2 evaluable patients
- 6 patients
- Expected enrollment in the Phase 2a trial
- Enrollment completion
- Q4 2026
- Expected for VIRAGE2
- Initial data
- Q3 2027
- Pharmacodynamic and safety/tolerability data anticipated from VIRAGE2
Previous Earnings Reports
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Reported VIRAGE2 first dosing and a six-patient plan, with cash runway into Q1 2027.
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Expanded VIRAGE Phase 2b results reported improved survival endpoints, with greater benefit after two doses.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pharmacodynamic medical
progression-free survival medical
oncolytic adenovirus technical
orphan drug designation regulatory
biologics license application regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
– 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
– Detailed analyses of data from the VIRAGE Phase 2b clinical trial published in Nature Medicine –
– Cash and cash equivalents of
ROCKVILLE, Md., Nov. 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).
-
- 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.
- 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.
- VIRAGE2 is expected to complete enrollment in Q4 2026, with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027.
- 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.
- 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.
- 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.
- 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.
- The proposed protocol builds on compelling Phase 1 clinical data in this ultra rare pediatric population for which there is no current treatment.
- 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.
- 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”).
- 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.
- 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 ). - 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 PREV50% of future regulatory and sales milestone payments, 33⅓% of royalty payments received by Theriva, and50% 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
Research and Development Expenses
Research and development expenses decreased to
Other Income/Expense
Other income was
Cash and Cash Equivalents
Cash and cash equivalents totaled
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
For further information, please contact:
Investor Relations
Kevin Gardner
LifeSci Advisors, LLC
| 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, | 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 | ) | ||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Theriva Biologics’ third-quarter 2026 financial results?
Theriva recorded a $1.471 million net loss, or $0.03 per share, versus $4.361 million, or $0.45 per share, a year earlier. General and administrative expenses fell to $923,000, while research and development expenses declined to $612,000.
When does Theriva expect VIRAGE2 enrollment and initial results?
Theriva expects enrollment completion in Q4 2026 and initial data on biological effects and safety/tolerability by Q3 2027. Four patients have received treatment, and the trial is expected to enroll six evaluable patients with metastatic pancreatic cancer.
How much of the Biossil asset-sale proceeds must Theriva pay PREV ABR?
Theriva paid PREV ABR $140,000 and must share future proceeds under the amended purchase agreement. PREV ABR is entitled to 50% of regulatory and sales milestones, 33⅓% of royalty payments and 50% of other consideration related to the transferred assets, up to an aggregate total of $13 million.
What dosing schedule is Theriva testing in VIRAGE2?
VIRAGE2 evaluates the safety and feasibility of at least three VCN-01 doses approximately two months apart, combined with standard-of-care chemotherapy in first-line metastatic pancreatic cancer. Successful results are expected to inform dosing for future combination trials, including a potential pivotal Phase 3 study.
Why did Theriva’s third-quarter 2026 general and administrative expenses decline?
The decline primarily reflected an $841,000 decrease in the fair value of contingent consideration, compared with a $633,000 increase a year earlier. Contingent consideration is a potential payment obligation whose recorded value can change. Higher legal fees partially offset the decrease.