Phio Pharmaceuticals Announces Agreement With U.S. cGMP Manufacturing Source For Drug Product, PH-762

A Critical Next Step in Advancing Phio’s PH-762 Program to Treat Cutaneous Carcinomas

Phio Pharmaceuticals Corp. is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer. Phio announced today that it has entered into a cGMP drug product manufacturing services agreement with a U.S. manufacturer for clinical supply for future clinical trials. The company will manufacture Phio’s lead compound PH-762 for both clinical trial and commercial supply.

“It is a pleasure to partner with an organization known for its quality and expertise in drug product manufacturing services,” said Mr. Robert Bitterman, Phio’s President and CEO. “Further, we value the strategic advantages of working with a U.S. based organization.”

Recent Company Highlights
Phio’s lead clinical candidate, PH-762, is being evaluated as an intratumoral therapy for cutaneous carcinomas. In its Phase 1b trial, Phio has reported that 22 patients completed treatment across five dose-escalation cohorts, with no dose-limiting toxicities or serious adverse events. The Company has also reported a pathological response rate in cSCC across all dosing cohorts of approximately 65%, including an 85% pathological response (6 of 7 patients) in the highest-dose cohort.

Phio has indicated that FDA engagement regarding next-stage clinical development is targeted for the second quarter of 2026 and has reported cash and cash equivalents projected to sustain operations into the first half of 2027.

About Phio Pharmaceuticals Corp.
Phio Pharmaceuticals Corp. is a clinical-stage siRNA biopharmaceutical company advancing its INTASYL gene silencing technology in immuno-oncology. Phio’s INTASYL compounds are designed to enhance the body’s immune cells to more effectively kill cancer cells. Notably, INTASYL is a self-delivering RNAi technology focused on immuno-oncology therapeutics without the need for formulation enhancements or manipulations to reach its target.

Phio’s lead clinical program is an INTASYL compound, PH-762, that silences the PD-1 gene implicated in various forms of skin cancer. The Phase 1b trial (NCT# 06014086) evaluated PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. PH-762 is a potential non-surgical treatment for skin cancers.

For more information, visit www.phiopharma.com.