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MARLBOROUGH, MASSACHUSETTS - Phio Pharmaceuticals Corp. (NASDAQ:PHIO), a $10.6 million market cap biotechnology company whose stock has gained over 22% year-to-date, announced Wednesday that its Safety Monitoring Committee has recommended dose escalation for the fifth and expected final cohort in its Phase 1b clinical trial of PH-762, following supportive safety data from the fourth cohort. According to InvestingPro analysis, the company maintains strong liquidity with a current ratio of 10.58, though it faces significant cash burn challenges.
The trial is evaluating the company’s lead siRNA compound for treating cutaneous squamous cell carcinoma (cSCC), melanoma, and Merkel cell carcinoma through intratumoral administration. While the company’s overall financial health score stands at "FAIR" per InvestingPro metrics, analysts maintain a bullish stance with a $14 price target.
Five patients were enrolled in the fourth cohort, including four with cSCC and one with Merkel cell carcinoma. The company reported no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions.
"We are encouraged by the continuing safety profile of PH-762 having now progressed through four escalating dose concentrations," said Mary Spellman, MD, Phio’s acting Chief Medical Officer, according to the press release.
To date, 15 patients have been treated across the first four cohorts. In the previous three cohorts, pathological response data showed complete tumor clearance in four of nine cSCC patients, with one patient showing greater than 90% clearance and another showing greater than 50% clearance. Three cSCC patients and one melanoma patient showed less than 50% clearance. No disease progression was observed in any patients.
The company expects to complete enrollment in the fifth cohort during the third quarter of 2025.
PH-762 is designed to silence the PD-1 gene implicated in various forms of skin cancer. The compound utilizes Phio’s INTASYL technology, which aims to enhance the body’s immune cells to more effectively target cancer cells.
In other recent news, Phio Pharmaceuticals has reported positive developments in its ongoing clinical trials for PH-762, a treatment for skin cancer. The Phase 1b trial has shown promising results, with two out of three patients in the third dose cohort achieving a complete pathologic response in cases of cutaneous squamous cell carcinoma. The therapy, part of Phio’s INTASYL siRNA technology, has been well-tolerated with no serious adverse events reported. The Safety Monitoring Committee has endorsed the continuation of the trial with higher doses, furthering the potential for PH-762 as a non-surgical treatment option.
Additionally, H.C. Wainwright has initiated coverage of Phio Pharmaceuticals with a Buy rating, setting a price target of $14.00, citing the innovative approach of PH-762. The firm also reaffirmed its Buy rating with a $4.00 price target following Phio’s recent financial report, highlighting the successful progress in clinical trials. Meanwhile, Phio has made strategic executive appointments, with Robert Infarinato and Lisa Carson stepping into new roles to enhance strategic development and finance operations. These changes are part of Phio’s broader efforts to expand the applications of its INTASYL siRNA technology in cancer treatment.
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