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Phio Pharmaceuticals Reports Promising Phase 1b Results for PH-762 in Skin Cancers, Plans FDA Engagement for 2026

By NewsRamp Editorial Team

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 Results for PH-762 in Skin Cancers, Plans FDA Engagement for 2026

Phio Pharmaceuticals Corp. reported encouraging results from its Phase 1b trial evaluating PH-762, an intratumoral therapy using INTASYL siRNA gene-silencing technology for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. The trial involved 22 patients across five dose-escalation cohorts, with the company reporting no dose-limiting toxicities or serious adverse events. At the maximum dose concentration, 6 of 7 patients responded, achieving 85% pathological response, while across all dosing cohorts for cSCC, the pathological response rate was approximately 65% with no disease progression among treated patients.

The company has targeted the second quarter of 2026 for FDA submission seeking guidance on next-stage clinical development and is advancing Chemistry, Manufacturing Controls and Toxicology fulfillment to satisfy future clinical registration trial initiation. Phio reported approximately $21.3 million in cash and cash equivalents, projected to sustain operations into the first half of 2027, supported by 2025 warrant inducement financings totaling approximately $12 million in net proceeds. The company strengthened its leadership team in February 2026, promoting Lisa Carson to Chief Financial Officer and Jennifer Phillips to Senior Vice President, Regulatory and Corporate Affairs, while 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, which selected Phio as a Featured Company, stated the company has reported encouraging response data with a favorable safety profile and is funded through key regulatory milestones. Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals, noted that with favorable patient safety and pathology data, FDA engagement planned for 2026, and runway extending into 2027, the company believes it is well positioned for the next stage of development. A dedicated Featured Company profile will be available at https://b2idigital.com/featured-companies.

Curated from NewMediaWire

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NewsRamp Editorial Team

NewsRamp Editorial Team

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