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

Phio Pharmaceuticals Corp. has been selected as a B2i Digital Featured Company as it advances clinical development of its intratumoral immunotherapy for skin cancers. The company reported approximately 65% pathological response rate in cutaneous squamous cell carcinoma patients treated with its lead candidate PH-762 across all dosing cohorts in a Phase 1b trial, with no disease progression observed among treated patients.

At the maximum dose concentration, the response rate reached 85% with 6 of 7 patients responding. The trial involved 22 patients across five dose-escalation cohorts, with no dose-limiting toxicities or serious adverse events reported. Phio’s proprietary INTASYL siRNA gene-silencing technology is designed to enhance immune cell activity against cancer cells by silencing the PD-1 gene implicated in various skin cancers.

The company has targeted the second quarter of 2026 for an 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. A dedicated Featured Company profile will be available at https://b2idigital.com/featured-companies.

Financial positioning supports these planned regulatory milestones, with approximately $21.3 million in cash and cash equivalents reported as of the company’s most recent update. This capital is projected to sustain operations into the first half of 2027, supported by 2025 warrant inducement financings totaling approximately $12 million in net proceeds.

Leadership changes announced in February 2026 include the promotion of Lisa Carson to Chief Financial Officer and Jennifer Phillips, Pharm.D., to Senior Vice President, Regulatory and Corporate Affairs. Kimberly Man was appointed Vice President of Program Development and Strategic Planning to support execution across PH-762 and PH-894 development 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. The investment firm’s analysis followed the company’s presentation of clinical data showing favorable patient safety and pathology outcomes.

‘We are pleased to support Phio Pharmaceuticals as it advances a differentiated intratumoral immunotherapy platform in large skin cancer markets,’ said David Shapiro, Chief Executive Officer of B2i Digital. ‘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, noted that ‘B2i Digital brings a focused approach to investor outreach’ as the company prepares for its next development phase. Beyond cSCC, PH-762 is being evaluated in melanoma and Merkel cell carcinoma, with the Phase 1b trial registered under NCT06014086. Additional information about the company’s technology and programs is available at www.phiopharma.com.

This news story relied on content distributed by NewMediaWire. Blockchain Registration, Verification & Enhancement provided by NewsRamp. The source URL for this press release is Phio Pharmaceuticals Reports Promising Phase 1b Results for Skin Cancer Therapy, Plans FDA Submission for 2026.

The post Phio Pharmaceuticals Reports Promising Phase 1b Results for Skin Cancer Therapy, Plans FDA Submission for 2026 appeared first on citybuzz.