Phio Pharmaceuticals Corp. has been selected as a B2i Digital Featured Company following encouraging clinical trial results for its lead cancer therapy candidate. The clinical-stage biopharmaceutical company reported that its PH-762 treatment achieved approximately 65% pathological response in cutaneous squamous cell carcinoma patients across all dosing cohorts in a Phase 1b trial, with no disease progression observed among treated patients.
The trial involved 22 patients across five dose-escalation cohorts, including a final cohort at maximum dose concentration. At the highest dose level, 6 of 7 patients responded, achieving 85% pathological response. Importantly, the company reported no dose-limiting toxicities or serious adverse events throughout the study, indicating a favorable safety profile for the intratumoral immunotherapy.
Phio's technology platform utilizes INTASYL® siRNA gene-silencing designed to enhance immune cell activity against cancer. The company is targeting multiple skin cancer indications with PH-762, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. A dedicated Featured Company profile will be available at https://b2idigital.com/featured-companies.
The company has indicated plans to submit for FDA guidance on next-stage clinical development in the second quarter of 2026. Concurrently, Phio is advancing Chemistry, Manufacturing Controls and Toxicology fulfillment to satisfy requirements for future clinical registration trials. This regulatory timeline positions the company for potential accelerated development if FDA feedback is positive.
Financially, Phio reported approximately $21.3 million in cash and cash equivalents, with projections indicating this will sustain operations into the first half of 2027. This extended runway is supported by 2025 warrant inducement financings that generated approximately $12 million in net proceeds. The financial stability provides the company with resources to navigate upcoming regulatory milestones without immediate fundraising pressure.
In preparation for these critical developments, Phio strengthened its leadership team in February 2026 with several key promotions and appointments. Lisa Carson was promoted to Chief Financial Officer, Jennifer Phillips, Pharm.D., to Senior Vice President of Regulatory and Corporate Affairs, and Kimberly Man was appointed Vice President of Program Development and Strategic Planning to support execution across PH-762 and PH-894 programs.
The clinical results and strategic positioning have drawn positive attention from analysts. H.C. Wainwright & Co. reiterated its Buy rating and $14 price target on PHIO following the safety-efficacy update, as noted in their February 10, 2026 research report. This analyst confidence reflects the potential market opportunity for effective skin cancer treatments with favorable safety profiles.
David Shapiro, Chief Executive Officer of B2i Digital, commented on the selection, stating, "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, emphasized the strategic importance of the B2i Digital partnership, noting, "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."
The combination of promising clinical data, planned regulatory engagement, extended financial runway, and strengthened leadership creates a significant inflection point for Phio Pharmaceuticals. The company's progress represents potential advancement in skin cancer treatment options, particularly for patients with cutaneous squamous cell carcinoma who may benefit from therapies with demonstrated efficacy and favorable safety profiles.
