Phio seeks FDA feedback on PH-762 after Phase 1b completion

Phio Pharmaceuticals submitted a meeting request and briefing package to the FDA after completing its Phase 1b study of PH-762 in cutaneous squamous cell carcinoma. The filing lays out the program’s next planned Phase 2b neoadjuvant study and could help shape the drug’s next development step.

Why it matters: - PH-762 is Phio Pharmaceuticals’ lead cancer program and a potential non-surgical treatment for skin cancers. - The FDA submission is meant to support the next stage of clinical development in cutaneous squamous cell carcinoma. - The company is targeting a disease area where better treatment options could matter for patients facing surgery-heavy care.

What happened: - Phio Pharmaceuticals said it submitted a meeting request and comprehensive briefing package to the FDA after formally completing its Phase 1b clinical study. - The package covers PH-762’s nonclinical development program, integrated clinical pharmacology data, and details from the completed Phase 1b study. - The submission also outlines the company’s next planned Phase 2b neoadjuvant clinical study in cutaneous squamous cell carcinoma. - Chief Executive Officer Robert J. Bitterman said the briefing package is a key achievement for the PH-762 program and an important step toward unlocking its clinical potential.

The details: - The briefing package includes the scientific rationale, study design and pharmacokinetic strategy for the next phase. - PH-762 uses Phio’s INTASYL siRNA gene silencing technology to target the PD-1 gene implicated in several forms of skin cancer. - The Phase 1b trial, identified as NCT# 06014086, evaluated PH-762 in cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. - Phio is preparing clinical supplies for the next planned study, with availability expected in the first quarter of 2027. - The dosing phase of the company’s nonclinical toxicology study has been completed. - Final activities supporting the next phase of clinical development are expected to be completed in the first quarter of 2027. - Phio describes PH-762 as a potential non-surgical treatment for skin cancers. - The company is a clinical-stage siRNA biopharmaceutical company based in King of Prussia, Pennsylvania. - Phio trades on Nasdaq under the ticker PHIO. - More information is available in the company’s profile and on Phio’s website.

Between the lines: - The FDA filing suggests Phio is moving from early clinical readout into a more defined development plan. - A neoadjuvant Phase 2b study indicates the company is exploring PH-762 before surgery, which can be strategically important in skin cancer treatment. - The timing points to a development push in early 2027, but the release includes the usual regulatory and execution risks that could affect the path forward.

What's next: - Phio expects to manufacture clinical supplies for the next study in time for use in the first quarter of 2027. - The company plans to meet with the FDA to discuss next steps in the clinical trial design and development of PH-762. - Further progress will depend on FDA feedback, completion of remaining development activities and the company’s ability to advance the program on schedule.

The bottom line: - Phio has taken a formal regulatory step that could move PH-762 toward a Phase 2b study in cutaneous squamous cell carcinoma, with key 2027 milestones now in sight.