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

By FisherVista

TL;DR

Phio Pharmaceuticals' PH-762 shows 85% pathological response at maximum dose, positioning it as a promising investment ahead of FDA guidance in Q2 2026.

Phio's Phase 1b trial of PH-762 in cSCC used five dose-escalation cohorts, achieving 65% pathological response with no serious adverse events.

PH-762's high response rates and safety profile offer new hope for treating skin cancers, potentially improving patient outcomes and quality of life.

Phio's siRNA technology silences PD-1 to enhance immune cells against cancer, with cash extending to 2027 and leadership team strengthened for upcoming milestones.

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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, highlighting its progress with PH-762, an intratumoral therapy for skin cancers. The company reported approximately 65% pathological response in cutaneous squamous cell carcinoma (cSCC) across all dosing cohorts in its Phase 1b trial, with no disease progression among treated patients. At the maximum dose concentration, 6 of 7 patients responded, achieving 85% pathological response, and no dose-limiting toxicities or serious adverse events were reported.

The trial involved 22 patients across five dose-escalation cohorts, evaluating PH-762 for cSCC, melanoma, and Merkel cell carcinoma. Phio's INTASYL siRNA gene-silencing technology is designed to enhance immune cell activity against cancer by silencing the PD-1 gene. The company has targeted FDA submission for guidance on next-stage clinical development in the second quarter of 2026 and is advancing Chemistry, Manufacturing Controls, and Toxicology fulfillment for future registration trials.

Phio reported approximately $21.3 million in cash and cash equivalents, with operations sustained into the first half of 2027, supported by 2025 warrant inducement financings totaling approximately $12 million in net proceeds. In February 2026, the company strengthened its leadership team, promoting Lisa Carson to Chief Financial Officer and Jennifer Phillips to Senior Vice President, Regulatory and Corporate Affairs, and appointing Kimberly Man as Vice President of Program Development and Strategic Planning.

H.C. Wainwright & Co. reiterated its Buy rating and $14 price target on PHIO following the safety-efficacy update in a February 10, 2026 research report. 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 on Phio Pharmaceuticals, visit https://www.phiopharma.com.

Curated from NewMediaWire

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FisherVista

FisherVista

@fishervista