Phio Pharmaceuticals Reports Promising Phase 1b Trial Results for Skin Cancer Therapy, Plans FDA Engagement in 2026

Phio Pharmaceuticals Corp. has been selected as a B2i Digital Featured Company as it advances clinical development of its INTASYL siRNA gene-silencing technology for cancer treatment. The company's lead candidate, PH-762, has shown promising results in a Phase 1b trial involving patients with cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. In the trial, 22 patients completed treatment across five dose-escalation cohorts, with no dose-limiting toxicities or serious adverse events reported, indicating a favorable safety profile.

At the maximum dose concentration, 6 of 7 patients responded, achieving an 85% pathological response rate. Across all dosing cohorts for cutaneous squamous cell carcinoma specifically, Phio reported a pathological response rate of approximately 65%, with no disease progression observed among all treated patients. These results are significant as they demonstrate both efficacy and safety for an intratumoral immunotherapy approach in difficult-to-treat skin cancers.

The company has targeted the second quarter of 2026 for FDA submission seeking guidance on next-stage clinical development. Phio is concurrently advancing Chemistry, Manufacturing Controls and Toxicology fulfillment to satisfy requirements for future clinical registration trial initiation. Financial positioning supports these planned activities, with approximately $21.3 million in cash and cash equivalents reported as of the most recent update, projected to sustain operations into the first half of 2027.

This financial runway has been supported by 2025 warrant inducement financings totaling approximately $12 million in net proceeds. In February 2026, Phio strengthened its leadership team ahead of upcoming regulatory engagement and clinical milestones, promoting Lisa Carson to Chief Financial Officer and Jennifer Phillips, Pharm.D., to Senior Vice President, Regulatory and Corporate Affairs, while appointing Kimberly Man as Vice President of Program Development and Strategic Planning to support execution across PH-762 and PH-894 programs.

In a February 10, 2026 research report, H.C. Wainwright & Co. reiterated its Buy rating and $14 price target on PHIO following the safety-efficacy update. David Shapiro, Chief Executive Officer of B2i Digital, stated, "We are pleased to support Phio Pharmaceuticals as it advances a differentiated intratumoral immunotherapy platform in large skin cancer markets. The company has reported encouraging response data with a favorable safety profile, strengthened its leadership team, and is funded through key regulatory milestones."

Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals, added, "B2i Digital brings a focused approach to investor outreach. With favorable patient safety and pathology data, FDA engagement planned for 2026, and runway extending into 2027, we believe we are well positioned for the next stage of development." A dedicated Featured Company profile will be available at https://b2idigital.com/featured-companies. For additional information about Phio's technology and clinical programs, visit http://www.phiopharma.com.