Phio Pharmaceuticals Corp. has finished enrolling 18 patients in its Phase 1b dose‑escalating study of the INTASYL siRNA compound PH‑762, an anti‑PD‑1 therapy designed for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The enrollment spanned five dose‑escalating cohorts, with the fifth and final cohort at the maximum dose now complete.
All patients have been evaluated for safety, and the company reports no dose‑limiting toxicities or clinically relevant treatment‑emergent adverse effects across any cohort. Pathology results, which will provide the first evidence of tumor response, are expected in the first quarter of 2026.
In its Q3 2025 financial results, Phio reported a net loss of $2.4 million and earnings per share of –$0.44, a beat of $0.01 versus the consensus estimate of –$0.45. The modest earnings beat was driven by interest income that offset higher operating expenses. The company also raised $13.4 million in gross proceeds from warrant exercises, extending its cash runway into the first half of 2027.
Phio’s leadership said the enrollment milestone and the recent financing give the company confidence to advance PH‑762 toward regulatory submission. They noted that the safety data, reviewed favorably by the Safety Monitoring Committee, support the continued development of the intratumoral siRNA platform.
Analysts welcomed the enrollment completion and the strengthened cash position, citing the positive safety profile and the company’s ability to fund the next phase of development without immediate financing pressure.
PH‑762 represents a novel approach to immunotherapy, delivering siRNA that silences PD‑1 locally within the tumor microenvironment. By concentrating the drug at the site of disease, the therapy aims to enhance antitumor immunity while minimizing systemic side effects associated with conventional checkpoint inhibitors. The successful completion of enrollment and the absence of dose‑limiting toxicities position Phio to move forward with Phase 2 studies and to potentially expand the treatment’s indication to other solid tumors.
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