(RTTNews) - Theriva Biologics, Inc. (TOVX), a clinical-stage company, reported financial results for the first quarter ended March 31, 2026, reflecting a narrower net loss and highlighted near-term milestones for its lead candidate VCN-01.
Company Profile
Theriva develops therapeutics for the treatment of cancer and related diseases.
The Company's lead clinical-stage candidate is VCN-01 (Zabilugene almadenorepvec), an oncolytic adenovirus designed to replicate selectively and aggressively within tumour cells and degrade the tumour stroma, an important physical and immunosuppressive barrier to cancer treatment.
First Quarter Results
Net losses attributable to common shareholders narrowed to $2.04 million compared to $4.32 million in the prior year.
As of March 31, 2026, cash and cash equivalents totalled $14.4 million and are expected to provide cash runway into the first quarter of 2027.
Near-Term Milestones
Theriva noted that it has reached alignment with the FDA on the Phase 3 trial design for VCN-01 (zabilugene almadenorepvec) for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC).
As the firm has finalised the pivotal Phase 3 study protocol, they plan to generate feasibility data for the intended Phase 3 macrocycle dosing regimen by conducting a small study in metastatic PDAC patients who receive 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 addition, VCN-01 is administered to retinoblastoma patients under a compassionate use program, which may provide dosing feasibility and tolerability data for a potential Phase 2/3 clinical trial.
If a protocol is submitted and agreed upon by the FDA, the firm expects the first patient enrolled in December 2026, with a rolling Biologics License Application (BLA) submission expected in 2029.
TOVZ has traded between $0.16 and $1.45 over the last year. The stock closed Tuesday's trade at $0.38, up 0.11%.
In the pre-market, TOVX is down 4.26% at $0.36.
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