-- Alignment with the FDA on the Phase 3 trial design of VCN-01 (zabilugene almadenorepvec) for treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) --
-- Additional data from VIRAGE Phase 2b clinical trial of VCN-01 in metastatic PDAC patients presented at the recent AACR Annual Meeting may reflect an immune-mediated mechanism of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver metastases --
-- VCN-01 administered to retinoblastoma patients under a compassionate use program, which is expected to provide dosing feasibility and tolerability data for a potential Phase 2/3 clinical trial --
-- Cash and cash equivalents of $14.4 million as of March 31, 2026; cash runway into Q1 2027 --
ROCKVILLE, Md., May 05, 2026 (GLOBE NEWSWIRE) -- Theriva$(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 first quarter ended March 31, 2026, and provided a corporate update.
"The first quarter of 2026 was marked by encouraging regulatory progress, " said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We were pleased to receive the minutes from our end-of-Phase 2 meeting with the FDA and align on the major elements of our proposed pivotal Phase 3 trial to evaluate VCN-01 with gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy in patients with metastatic PDAC. The FDA feedback was consistent with the positive scientific advice previously received from the EMA, with both agencies agreeing to repeated dosing 'macrocycles' of VCN-01 and SoC chemotherapy. Additional data analyses presented in a poster at the AACR Annual Meeting in April 2026 concluded that the additional data may reflect a potential immune-mediated mechanism of action for VCN-01 in metastatic PDAC. We believe that repeated macrocycle dosing of VCN-01 and chemotherapy may enhance this immune action, providing increased and more durable tumor responses and longer survival. As we finalize the pivotal Phase 3 study protocol, we plan to generate feasibility data for the intended Phase 3 macrocycle dosing regimen, by conducting a small study in metastatic PDAC patients administering more frequent VCN-01 doses for a longer period. This dosing feasibility study is expected to commence at a single site in Spain in the second half of this year. In parallel with our PDAC program, discussions are ongoing with clinicians and key opinion leaders to design a Phase 2/3 clinical trial protocol for the VCN-01 plus topotecan combination in retinoblastoma patients. We believe that intravitreal coadministration of VCN-01 with topotecan may provide a new treatment option for children with refractory retinoblastoma and vitreous seeds, which remains an unmet medical need in patients with this rare disease. In the first quarter of 2026, we made VCN-01 available to investigators for compassionate use in treating patients with retinoblastoma. We expect that outcomes from these compassionate use patients will provide valuable information on the feasibility and tolerability of this combination for use in a potential Phase 2/3 clinical trial. If a protocol is ultimately submitted to, and agreed by, the FDA, we expect the first patient to be enrolled in December 2026, with rolling Biologic Licensing Application (BLA) submissions expected to be made in 2029 (if successful), targeting potential approval of the BLA prior to September 30, 2029."
Recent Highlights and Anticipated Milestones
VCN-01
Metastatic PDAC:
-- As recently announced, Theriva received minutes from Type B End-of-Phase
2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA)
regarding the design of a Phase 3 clinical study of lead clinical
candidate VCN-01 in combination with standard-of-care chemotherapy for
the treatment of metastatic PDAC. The FDA provided general agreement with
Theriva's proposed design for a Phase 3 clinical trial, which closely
tracks the design of the successful VIRAGE Phase 2 trial. As announced in
2025, the VIRAGE trial met its primary endpoints, with metastatic PDAC
patients receiving VCN-01 with SoC chemotherapy having improved overall
survival (OS), progression-free survival $(PFS)$ and duration of response
(DoR) compared to SoC chemotherapy alone. Greater improvements in OS and
PFS were observed in patients who received two doses of VCN-01, leading
Theriva to plan the Phase 3 trial to include repeat dosing and an
adaptive design aimed to optimize the trial's timelines and outcomes.
-- Tumor response, biomarker, and subgroup analyses from the VIRAGE Phase 2b
clinical trial were recently presented at the American Association for
Cancer Research (AACR) 2026 annual meeting. The poster concluded that the
additional data may reflect an immune-mediated mechanism of action for
VCN-01, with later and more durable responses and improved overall
survival and progression-free survival in patients treated with VCN-01
plus SoC chemotherapy, compared to SoC chemotherapy alone. Improved
overall survival was observed in VCN-01-treated patients across multiple
subgroups, including patients with liver metastases.
Retinoblastoma:
-- Made VCN-01 available to investigators for compassionate use in treating
patients with retinoblastoma. Two patients have been treated with
intravitreal VCN-01 in combination with intravitreal topotecan and are
being followed by the treating physicians.
-- Continued discussions with clinicians and key opinion leaders to design a
Phase 2/3 clinical trial protocol for the VCN-01 plus topotecan
combination in retinoblastoma patients.
First Quarter Ended March 31, 2026 Financial Results
General and administrative expenses
General and administrative expenses increased to $2.1 million for the three months ended March 31, 2026, from $1.4 million for the three months ended March 31, 2025. This increase of 43% is primarily comprised of an increase in legal fees, investor relations costs, registration fees, and salary costs. The charge related to stock-based compensation expense was $111,000 for the three months ended March 31, 2026, compared to $54,000 for the three months ended March 31, 2025.
Research and Development Expenses
Research and development expenses decreased to $355,000 for the three months ended March 31, 2026, from approximately $3.0 million for the three months ended March 31, 2025. This decrease of 88% is primarily the result of lower clinical trial expenses related to the completion of our VIRAGE Phase 2b clinical trial of VCN-01 in PDAC, the recognition of the Spanish research and development rebate, lower indirect costs related to compensation and lower clinical trial expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, offset by higher patent expenses related to SYN-020. We anticipate research and development expense to decrease in the near future until we commence additional clinical trials as we focus on regulatory interactions regarding a proposed pivotal clinical trial of VCN-01 in retinoblastoma, continue with VCN-01 manufacturing scale-up activities, commence a proposed Phase 2a study in metastatic PDAC patients evaluating VCN-01 dosing frequency and continue limited preclinical studies supporting VCN-01 and VCN-12, the first candidate from our VCN-X discovery program. The charge related to stock-based compensation expense was $24,000 for the three months ended March 31, 2026, compared to $46,000 for the three months ended March 31, 2025.
Other Income/Expense
Other income was $83,000 for the three months ended March 31, 2026 compared to other income of $93,000 for the three months ended March 31, 2025. Other income for the three months ended March 31, 2026 is comprised of interest income of $82,000 and an exchange gain of $1,000. Other income for the three months ended March 31, 2025 is comprised of interest income of $96,000 and an exchange loss of $3,000.
Cash and cash equivalents
Cash and cash equivalents totaled $14.4 million as of March 31, 2026, an increase of $1.4 million from December 31, 2025. During the year ended December 31, 2025 and the quarter ended March 31, 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 $2.0 million for the year ended December 31, 2025 and the quarter ended March 31, 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 with SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients has completed 2 of 3 cohorts, with initiation of the third cohort dependent on additional funding. SYN-004 (ribaxamase) 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
(MORE TO FOLLOW) Dow Jones Newswires
May 05, 2026 16:30 ET (20:30 GMT)
Comments