TOVX · Theriva Biologics, Inc.

Theriva Biologics' 8-K discloses new analyses from the VIRAGE Phase 2b trial, a randomized, open-label study in chem naive metastatic pancreatic ductal adenocarcinoma (mPDAC) patients. The data, presented via poster CT162 at the AACR Annual Meeting on April 20, 2026, demonstrate that adding two IV doses of VCN-01 (zabilugene almadenorepvec), an oncolytic adenovirus, to standard gemcitabine/nab-paclitaxel (GnP) chemotherapy improves key survival endpoints. Kaplan-Meier analyses show improved overall survival (OS) and progression-free survival (PFS) for VCN-01 + GnP versus GnP alone, with late curve separation suggesting an immune-mediated mechanism, consistent with VCN-01's design to degrade tumor stroma, enhance chemotherapy access, and boost immunogenicity. Response quality was superior with VCN-01 + GnP, featuring later onset, higher magnitude, and longer duration of responses, alongside better CA19-9 dynamics. Subgroup analyses confirm OS benefits across categories, notably liver metastases (common in mPDAC), with multivariate adjustment verifying independence from baseline imbalances. Patients receiving a second VCN-01 dose prior to cycle 4 showed amplified OS/PFS gains. Secondary endpoints include ORR of 39.6% (vs 31.3%) and DCR of 77.1% (vs 70.8%). CEO Steven Shallcross highlighted confidence in VCN-01's potential, noting regulatory alignment with FDA and EMA for a pivotal Phase 3 trial evaluating multiple doses in first-line mPDAC, plus plans for a dosing optimization study. The full poster is Exhibit 99.2; press release is Exhibit 99.1 (not filed). This advances VCN-01 toward Phase 3, targeting high-unmet-need mPDAC where <10% cases are resectable at diagnosis.