Phio Pharmaceuticals Corp. reports developments as a clinical-stage siRNA biopharmaceutical company advancing its proprietary INTASYL® gene-silencing technology for immuno-oncology. Company updates center on PH-762, an INTASYL compound designed to silence the PD-1 gene and evaluated as an intratumoral therapy for cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma.
Recurring news themes include PH-762 clinical results, safety and pathology data, nonclinical toxicology work, cGMP clinical-supply manufacturing, regulatory-development steps, financial results, equity financing activity and investor presentations. Coverage also reflects the company's use of self-delivering RNAi technology intended to enhance immune-cell activity against tumor cells without specialized formulation or delivery systems.
Phio Pharmaceuticals (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company, announced its participation in Renmark Financial Communications' Virtual Non-Deal Roadshow Series. CEO Robert Bitterman will present on June 30, 2025, at 10:00 am EST, providing updates on the company's INTASYL gene silencing technology and their ongoing clinical trials.
The presentation will focus on their lead compound PH-762 for skin cancer treatment, for which they recently reported positive interim safety and efficacy results in their Phase 1b dose escalation clinical trial. The event will include a live Q&A session, with a replay available on Renmark's website.
Phio Pharmaceuticals (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company, announced its participation in the upcoming Sidoti Micro-Cap Virtual Investor Conference. CEO and Chairman Robert Bitterman will present on May 22, 2025, at 10:00 AM ET, providing updates on the company's proprietary INTASYL gene silencing technology and progress on their ongoing clinical trial of PH-762 for skin cancer treatment.
The presentation will be accessible via webcast, and Bitterman will also host one-on-one meetings with investors during the conference on May 21-22, 2025. Registration for both the presentation and individual meetings is free and available through Sidoti's platform.
Phio Pharmaceuticals (NASDAQ: PHIO) reported positive results from the third cohort of its Phase 1b clinical trial for PH-762, a skin cancer treatment. Two out of three patients with cutaneous squamous cell carcinoma (cSCC) achieved complete pathologic response (100% tumor clearance), while one patient showed non-response. Across all three cohorts, involving 10 patients total (9 cSCC, 1 melanoma), 4 cSCC patients achieved complete response, one showed near-complete response (>90%), and one had partial response (>50%).
The trial evaluates PH-762's safety and tolerability in various skin cancer stages. Notably, no dose-limiting toxicities or significant adverse effects were observed, with the treatment being well-tolerated across all dose cohorts. The fourth cohort is currently enrolling, with trial completion expected in Q3 2025.
Phio Pharmaceuticals (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company, announced its participation in the Renmark Financial Communications Virtual Non-Deal Roadshow Series. CEO and Chairman Robert Bitterman will present on May 7, 2025, at 2:00 pm EST, providing updates on the company's proprietary INTASYL gene silencing technology and progress on the ongoing clinical trial of PH-762 for skin cancer treatment. The presentation will include a live Q&A session, with a replay available on Renmark Financial Communications' website.
Phio Pharmaceuticals (NASDAQ: PHIO) announced positive safety results for the third cohort in its Phase 1b clinical trial of PH-762, their lead INTASYL® siRNA compound for skin cancer treatment. The Safety Monitoring Committee recommended advancing to the fourth dose escalation cohort following successful results in three cutaneous squamous cell carcinoma patients, who showed no serious adverse events or dose-limiting toxicities.
The multi-center trial (NCT 06014086) evaluates PH-762's safety and tolerability in cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. Prior results from cohorts 1 and 2, comprising seven patients, showed promising outcomes. In the second cohort, two patients achieved complete response (100% tumor clearance) and one patient showed partial response (90% clearance) by Day 36. All three patients in cohort 1 and one patient in cohort 2 maintained stable disease.
Phio Pharmaceuticals (NASDAQ: PHIO) announced two podium presentations at the 11th Annual Immunotherapy of Cancer Conference in Munich, Germany on April 3, 2025. The presentations focus on their lead INTASYL siRNA product candidates:
1. PH-762: An INTASYL siRNA compound targeting PD-1, currently in clinical trials (NCT 06014086) as a neoadjuvant intratumoral therapy for cutaneous malignancies. The therapy has shown promising preclinical efficacy and favorable tolerability.
2. PH-894: An INTASYL siRNA compound that selectively silences BRD4, enhancing NK cell activation and proliferation without off-target effects, aimed at improving adoptive cell therapy.
The presentations will be delivered by Melissa Maxwell, Phio's Director of Research and Program Management, in Plenary Sessions 3 and 11 on April 3rd and 5th, 2025, respectively.
Phio Pharmaceuticals (NASDAQ: PHIO) reported its 2024 financial results and provided updates on its PH-762 clinical trial progress. The company's Phase 1b trial for PH-762, treating cutaneous carcinomas through intratumoral injection, showed promising results with 2 complete responses and 1 partial response in the second cohort. The third cohort is fully enrolled, with study completion expected in Q3 2025.
Financial highlights include raising $9.2 million through offerings and $2.9 million from warrant exercises. The company reported cash position of $5.4 million as of December 31, 2024, with net loss decreasing to $7.2 million ($9.08 per share) from $10.8 million in 2023. Research and development expenses decreased by 42% to $2.7 million, while general and administrative expenses reduced by 14% to $3.7 million.
The company implemented cost rationalization measures, including relocating to a smaller facility and terminating its Clinical Co-Development Agreement with AgonOx. Phio's patent portfolio includes 77 issued patents, with 69 covering its INTASYL technology.
Phio Pharmaceuticals (NASDAQ: PHIO) presented interim results from its Phase 1b clinical study of PH-762 at the American Academy of Dermatology's Late-Breaking Research session. The study evaluates the safety and tolerability of intratumoral PH-762 in cutaneous carcinomas.
In the second dose cohort of four patients, two patients with cutaneous squamous cell carcinoma (cSCC) achieved complete response (100% pathological cure), one achieved partial response (90% pathological cure), and one showed stable disease. The study has completed required safety enrollment for its third dose cohort, with the fourth dose cohort screening planned for early April.
PH-762 utilizes INTASYL® siRNA gene silencing technology to enhance immune cells' effectiveness in killing cancer cells. The research focuses on cSCC, melanoma, and Merkel cell carcinoma, with stages 1 and 2 cSCC representing 77% of all new cSCC cases annually.