– First patients dosed in the VIRAGE2 Phase 2a clinical study evaluating more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) the goal of which is to improve treatment outcomes in metastatic pancreatic ductal adenocarcinoma (PDAC) patients –
– Cash and cash equivalents of
“We have successfully converted last quarter’s regulatory achievements into clinical progress in the VCN-01 program,” said
Recent Highlights and Anticipated Milestones
VCN-01
Metastatic PDAC:
- As recently announced, the first patients have been dosed in the VIRAGE2 Phase 2a clinical trial entitled “A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer” (EUCT: 2026-525566-21-00; NCT07701486).
- The VIRAGE2 study design incorporates feedback from both the
European Medicines Agency (EMA) and theU.S. Food and Drug Administration (FDA) recognizing improved survival outcomes in the VIRAGE Phase 2b trial in metastatic PDAC patients treated with 2 doses of VCN-01 (in combination with standard-of-care chemotherapy), highlighting the possibility that more frequent repeated dosing of VCN-01 may provide additional clinical benefit. - The VIRAGE2 trial will 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. Results from the VIRAGE2 study will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial.
- VIRAGE2 is expected to complete enrollment during the second half of 2026, and initial pharmacodynamic and safety/tolerability data are anticipated by Q3 2027.
- The VIRAGE2 study design incorporates feedback from both the
Retinoblastoma:
- Undertook extensive discussions with key opinion leaders and completed 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.
- Proposed clinical trial protocol builds on compelling Phase 1 clinical data in this ultra rare population for which there is no current treatment.
- Plan to discuss the proposed clinical trial protocol with the FDA in Q3 2026.
- VCN-01 has Orphan Drug Designation from both the FDA and 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.
Head & Neck Squamous Cell Carcinoma:
- Clinical and translational results from the Phase 1 clinical trial of VCN-01 in refractory or metastatic head & neck squamous cell carcinoma (HNSCC) patients (whose disease progressed despite previous therapies, including anti-PD-(L)1 immune checkpoint inhibitors) were published in the journal
Clinical Cancer Research in an online first article titled “Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy”.- In the Phase 1 trial, prolonged overall survival (OS) was observed in these heavily pre-treated refractory HNSCC patients administered intravenous VCN-01 prior to the immune checkpoint inhibitor durvalumab (sequential delivery).
- Pharmacokinetic, tissue biopsy, radiomic and transcriptomic results all support the proposed VCN-01 stroma-degrading and immune enhancing modes-of-action, resensitizing refractory tumors to durvalumab.
- These findings support further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies in HNSCC and potentially other cancer indications.
Second Quarter Ended
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 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 candidate 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 remains open 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. Enrollment is paused and completion of this trial is pending receipt of grant funding or funding through a partnership or other collaboration. 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 the results from the VIRAGE2 trial informing the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial in first-line metastatic PDAC patients when coadministered with chemotherapy; a repeated VCN-01 dosing regimen improving outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors, and other emerging classes of cancer treatments; more frequent repeated administration of VCN-01 further derisking future Phase 3 clinical trials; more frequent repeated dosing of VCN-01 providing additional clinical benefit; completing enrollment into the VIRAGE2 trial in H2 2026 with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027; administering at least 3 doses of VCN-01 in the VIRAGE2 trial given approximately 2 months apart in combination with standard-of-care chemotherapy; the trial enrolling 6 patients; discussing the proposed clinical trial protocol with the FDA in Q3 2026; the findings in the Phase 1 clinical trial of VCN-01 in HNSCC supporting further clinical development of VCN-01 with immune checkpoint inhibitors or other immune modulating anticancer therapies in HNSCC.. 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 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
| Theriva Biologics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (In thousands except share and par value amounts) | ||||||||
(unaudited) | ||||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 11,337 | $ | 13,056 | ||||
| Tax credit receivable | 1,681 | 3,351 | ||||||
| Prepaid expenses and other current assets | 653 | 1,060 | ||||||
| Total Current Assets | 13,671 | 17,467 | ||||||
| Non-Current Assets | ||||||||
| Property and equipment, net | 173 | 222 | ||||||
| Restricted cash | 44 | 46 | ||||||
| Right of use asset | 1,825 | 803 | ||||||
| In-process research and development | 19,064 | 19,619 | ||||||
| Deposits and other assets | 80 | 82 | ||||||
| Total Assets | $ | 34,857 | $ | 38,239 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 984 | $ | 1,014 | ||||
| Accrued expenses | 6,418 | 6,276 | ||||||
| Contingent consideration, current portion | 2,650 | — | ||||||
| Accrued employee benefits | 290 | 443 | ||||||
| Deferred research and development tax credit-current portion | 1,210 | 1,675 | ||||||
| Loans payable-current | 34 | 57 | ||||||
| Operating lease liability-current portion | 525 | 549 | ||||||
| Total Current Liabilities | 12,111 | 10,014 | ||||||
| Non-current Liabilities | ||||||||
| Non-current contingent consideration | 7,169 | 10,004 | ||||||
| Loan Payable - non-current | 1,620 | 1,671 | ||||||
| Non-current deferred research and development tax credit | 396 | 815 | ||||||
| Non-current operating lease liability | 1,374 | 352 | ||||||
| Total Liabilities | 22,670 | 22,856 | ||||||
| Commitments and Contingencies (Note 14) | — | — | ||||||
| Stockholders’ Equity: | ||||||||
| Common stock, | 45 | 34 | ||||||
| Additional paid-in capital | 376,154 | 373,592 | ||||||
| (288 | ) | (288 | ) | |||||
| Accumulated other comprehensive loss | 247 | 755 | ||||||
| Accumulated deficit | (363,971 | ) | (358,710 | ) | ||||
| Total Stockholders’ Equity | 12,187 | 15,383 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 34,857 | $ | 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 | For the six months ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| License Revenue | $ | — | $ | — | $ | 300 | $ | — | ||||||||
| Operating Costs and Expenses: | ||||||||||||||||
| General and administrative | 2,027 | 11,179 | 4,099 | 12,628 | ||||||||||||
| Research and development | 1,268 | 1,953 | 1,623 | 4,921 | ||||||||||||
| Total Operating Costs and Expenses | 3,295 | 13,132 | 5,722 | 17,549 | ||||||||||||
| Loss from Operations | (3,295 | ) | (13,132 | ) | (5,422 | ) | (17,549 | ) | ||||||||
| Other Income/Expense: | ||||||||||||||||
| Foreign currency exchange (loss) gain | (1 | ) | 20 | — | 17 | |||||||||||
| Interest income | 79 | 54 | 161 | 150 | ||||||||||||
| Total Other Income | 78 | 74 | 161 | 167 | ||||||||||||
| Net Loss before income taxes | (3,217 | ) | (13,058 | ) | (5,261 | ) | (17,382 | ) | ||||||||
| Income tax benefit | — | — | — | — | ||||||||||||
| Net Loss Attributable to Common Stockholders | $ | (3,217 | ) | $ | (13,058 | ) | $ | (5,261 | ) | $ | (17,382 | ) | ||||
| Net Loss Per Share - Basic and Dilutive | $ | (0.07 | ) | $ | (1.93 | ) | $ | (0.12 | ) | $ | (3.64 | ) | ||||
| Weighted average number of shares outstanding during the period - Basic and Dilutive | 45,892,668 | 6,752,953 | 43,496,012 | 4,778,669 | ||||||||||||
| Net Loss | (3,217 | ) | (13,058 | ) | (5,261 | ) | (17,382 | ) | ||||||||
| (Loss) gain on foreign currency translation | (130 | ) | 1,317 | (508 | ) | 1,971 | ||||||||||
| Total comprehensive loss | $ | (3,347 | ) | $ | (11,741 | ) | $ | (5,769 | ) | $ | (15,411 | ) | ||||
