-- 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 $11.3 million as of June 30, 2026; cash runway into Q1 2027 --
ROCKVILLE, Md., Aug. 11, 2026 (GLOBE NEWSWIRE) -- Theriva$(TM)$ 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 second quarter ended June 30, 2026, and provided a corporate update.
"We have successfully converted last quarter's regulatory achievements into clinical progress in the VCN-01 program," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Dosing of the first patients in the VIRAGE2 trial brings us closer to refining a 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 may also improve outcomes when combined with other cancer interventions, including immuno-oncology products, RAS inhibitors, and other emerging classes of cancer treatments. If more frequent repeated administration of VCN-01 is feasible and well-tolerated, use of this dosing regimen may further derisk future Phase 3 clinical trials."
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 the U.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.
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 June 30, 2026 Financial Results
General and Administrative Expenses
General and administrative expenses decreased to $2.0 million for the three months ended June 30, 2026, from $11.2 million for the three months ended June 30, 2025. This decrease of 82% is primarily comprised of the prior year increase in fair value of the contingent consideration adjustment of $9.2 million due to the VIRAGE Phase 2b clinical trial of VCN-01 in PDAC achieving its primary survival and safety endpoints, offset set by current year increase in legal fees. The charge related to stock-based compensation expense was $110,000 for the three months ended June 30, 2026, compared to $97,000 for the three months ended June 30, 2025.
Research and Development Expenses
Research and development expenses decreased to $1.3 million for the three months ended June 30, 2026, from $2.0 million for the three months ended June 30, 2025. This decrease of 35% is primarily the result of lower indirect cost related to compensation expense and lower direct clinical trial expenses related to the Company's Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients and lower expenses related to SYN-020, offset by higher direct expenses related to VCN-01 manufacturing activities and expenses associated with the planning for the Phase 2a study in metastatic PDAC patients evaluating more frequent VCN-01 dosing for a longer period.
Other Income/Expense
Other income was $78,000 for the three months ended June 30, 2026, compared to other income of $74,000 for the three months ended June 30, 2025. Other income for the three months ended June 30, 2026 is comprised of interest income of $79,000 and an exchange loss of $1,000. Other income for the three months ended June 30, 2025 is comprised of interest income of $54,000 and an exchange gain of $20,000.
Cash and Cash Equivalents
Cash and cash equivalents totaled $11.3 million as of June 30, 2026, a decrease of $1.7 million from December 31, 2025. During the year ended December 31, 2025 and the quarter ended June 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 $5.3 million for the year ended December 31, 2025 and the six months ended June 30, 2026, respectively.
About Theriva(TM) Biologics, Inc.
Theriva(TM) 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(TM) Biologics' website at www.therivabio.com.
Forward-Looking Statement
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