Core Insights - Phio Pharmaceuticals Corp. has entered into a cGMP drug product manufacturing services agreement with a U.S. manufacturer for clinical supply of its lead compound PH-762, aimed at future clinical trials [1][2] - The lead clinical candidate PH-762 is being evaluated as an intratumoral therapy for cutaneous carcinomas, with a reported pathological response rate of approximately 65% across all dosing cohorts in its Phase 1b trial [2][5] - The company anticipates FDA engagement regarding the next stage of clinical development in the second quarter of 2026 and has sufficient cash reserves to sustain operations into the first half of 2027 [3] Company Overview - Phio Pharmaceuticals Corp. is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology to combat cancer [1][4] - The INTASYL technology enhances the body's immune cells to effectively kill cancer cells without the need for formulation enhancements [4] - PH-762 targets the PD-1 gene, which is implicated in various forms of skin cancer, and is being evaluated for the treatment of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [5]

Core Viewpoint - Phio Pharmaceuticals Corp. is advancing its lead product candidate, PH-762, which utilizes INTASYL® gene silencing technology for the treatment of skin cancers, with a presentation scheduled at the American Academy of Dermatology's Late-Breaking Research Session on March 28, 2026 [1][2]. Company Highlights - PH-762 is being evaluated as an intratumoral therapy for cutaneous squamous cell carcinoma (cSCC), melanoma, and Merkel cell carcinoma [4]. - In the Phase 1b trial, 22 patients completed treatment across five dose-escalation cohorts, reporting no dose-limiting toxicities or serious adverse events [4]. - The pathological response rate in cSCC across all dosing cohorts is approximately 65%, with an 85% response rate in the highest-dose cohort [4]. Clinical Development - The upcoming presentation will focus on the results of the Phase 1b clinical study (NCT 06014086) assessing the safety and tolerability of PH-762 [2][3]. - Preliminary clinical evidence suggests that intratumoral PH-762 may provide substantial clinical benefits, including notable pathologic response and modest mean reductions in tumor burden [3]. Future Plans - The company plans to engage with the FDA regarding the next stage of clinical development in the second quarter of 2026 [5]. - Phio has reported cash and cash equivalents that are projected to sustain operations into the first half of 2027 [5].

Core Insights - Phio Pharmaceuticals has completed the treatment phase for its lead clinical candidate PH-762, showing favorable safety, tolerability, and pathology data [1][2] - The company has strengthened its balance sheet with $23.7 million in net proceeds from financings and warrant exercises, extending its cash runway into the first half of 2027 [1][5] Clinical Development - PH-762 is being evaluated in a Phase 1b dose-escalating clinical trial for patients with cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, with a total of 22 patients enrolled [2] - The trial aims to assess the safety and tolerability of PH-762 and determine the appropriate dose for further studies, with an FDA submission planned for Q2 2026 [2] Corporate Updates - In July 2025, Phio entered into a drug substance development services agreement with a US manufacturer for the cGMP manufacture of PH-762, supporting future clinical development [3] - A development services agreement was also established in December 2025 for a non-clinical toxicology study required by the FDA before pivotal human trials [4] Financial Performance - As of December 31, 2025, Phio reported cash and cash equivalents of approximately $21.0 million, a significant increase from $5.4 million in 2024 [8] - Research and development expenses rose by 27% to $4.6 million, driven by advancements in the PH-762 program and increased employee compensation [9] - General and administrative expenses increased by 23% to $4.6 million, attributed to higher professional services and stock-based compensation [10] - The net loss for 2025 was approximately $8.7 million, or ($1.45) per share, compared to a net loss of $7.2 million, or ($9.08) per share in 2024 [11][16] Patent Portfolio - Phio's patent portfolio consists of 54 issued patents, with 49 covering the INTASYL platform, including 27 related to immuno-oncology compounds [6] - There are 20 pending patent applications that could enhance the company's therapeutic offerings, with potential expiration dates ranging from 2029 to 2044 [6] Scientific Engagement - In 2025, Phio presented new data on PH-762 at several prominent conferences, including AACR and SITC, and was invited to present at the AAD [7]

Core Insights - Phio Pharmaceuticals Corp. reported a 70% overall response rate in its Phase 1b clinical trial for the treatment of cutaneous squamous cell carcinoma (cSCC) using the INTASYL compound PH-762, with 100% clearance observed in 10 out of 14 responders [1][4] - The trial demonstrated favorable safety and tolerability, with no dose-limiting toxicities or clinically relevant adverse effects reported across all dose escalation cohorts [3][4] Summary by Sections Clinical Trial Results - A total of 22 patients with cutaneous carcinomas completed treatment in the Phase 1b trial, with 20 patients having cSCC. Among these, 14 were pathologic responders, including 10 with complete response (100% clearance), 2 with major/near clear response (greater than 90% clearance), and 2 with partial response (greater than 50% clearance) [2] - One patient with metastatic Merkel cell carcinoma also showed a partial response with greater than 50% clearance, while six cSCC patients and one melanoma patient had responses of less than 50%, but none experienced disease progression [2] Safety and Tolerability - PH-762 was well tolerated in all patients across five dose escalation cohorts, with drug concentration increased 20-fold from the first to the final cohort [3] - Safety data from an extended follow-up period is expected to be reported in the second quarter of 2026 [3] Company Overview - Phio Pharmaceuticals Corp. is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology aimed at treating various forms of skin cancer [6] - The lead clinical program, PH-762, targets the PD-1 gene and is being evaluated for its potential as a non-surgical treatment for skin cancers [6]

Core Insights - Phio Pharmaceuticals Corp. has received FDA acceptance for a nonclinical protocol study design, marking a significant advancement in the drug development pathway for PH-762, a treatment for skin cancer [1][3] - The company plans to commence a toxicology study in the first quarter of 2026, which is a prerequisite for initiating human pivotal trials [1] - Positive interim results from an ongoing Phase 1b clinical trial of PH-762 show promising safety and efficacy, with no dose-limiting toxicities reported [2] Group 1: Drug Development Progress - The FDA has accepted the nonclinical protocol study design for PH-762, allowing the company to move forward with necessary studies [1][3] - A toxicology study is set to begin in Q1 2026, which is essential for progressing to human trials [1] - The company is also working on delivering a commercially viable drug product by 2026, adhering to FDA's Good Manufacturing Practices [1][3] Group 2: Clinical Trial Results - The Phase 1b trial has treated 18 patients with cutaneous carcinomas, showing a cumulative pathologic response in 16 patients, including six with complete response (100% clearance) [2] - No patients exhibited clinical progression of disease during the trial, and PH-762 was well tolerated across all dose cohorts [2] - The trial results indicate a promising safety profile, with no dose-limiting toxicities or clinically relevant adverse effects reported [2] Group 3: Company Overview - Phio Pharmaceuticals Corp. is focused on developing therapeutics using its proprietary INTASYL® gene silencing technology, particularly in the field of immuno-oncology [4] - The lead clinical program, PH-762, targets the PD-1 gene associated with various skin cancers, positioning it as a potential non-surgical treatment option [4] - The ongoing Phase 1b trial is evaluating PH-762 for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [4]

Core Insights - Phio Pharmaceuticals Corp. announced promising pathologic results from its ongoing Phase 1b trial for PH-762, showing 100% tumor clearance in one patient, over 90% in another, and over 50% in a third patient with cutaneous squamous cell carcinoma (cSCC) [2][3] - The trial has treated a total of 18 patients with cutaneous carcinomas, with cumulative results indicating six complete responses, two near complete responses, and two partial responses [3] - The Safety Monitoring Committee confirmed no dose-limiting toxicities or clinically relevant adverse effects at the maximum dose concentration, indicating a favorable safety profile for PH-762 [6][7] Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology aimed at treating various forms of skin cancer [9] - The lead clinical program, PH-762, targets the PD-1 gene and is being evaluated for its potential as a non-surgical treatment for skin cancers, including cSCC, melanoma, and Merkel cell carcinoma [9] Trial Design and Results - The Phase 1b trial is designed to assess the safety and tolerability of intratumoral PH-762 in patients with Stages 1, 2, and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma, with pathologic responses evaluated approximately five weeks post-injection [4] - The trial has shown no clinical progression of disease in any patients treated thus far, and additional patients may continue to be screened and treated as part of the fifth cohort [3][5]

Core Insights - Phio Pharmaceuticals has reported promising pathology results from its ongoing Phase 1b clinical trial, indicating potential efficacy of its treatment PH-762 for skin cancers [2][3][5]. Group 1: Clinical Trial Results - In the fourth cohort of the trial, one patient with cutaneous squamous cell carcinoma (cSCC) achieved a complete pathologic response, indicating 100% tumor clearance [2][4]. - A patient with Stage 4 metastatic Merkel cell carcinoma showed a partial response with over 50% tumor clearance [2][4]. - Two patients with cSCC exhibited pathologic non-response, with less than 50% tumor clearance, while results for one remaining patient are still pending [2][4]. Group 2: Safety and Tolerability - The Phase 1b trial has treated a total of 15 patients across four cohorts, with no dose-limiting toxicities or significant treatment-emergent adverse effects reported [3][5]. - PH-762 has been well tolerated among all enrolled patients, with no clinical progression of disease observed [3][5]. Group 3: Future Directions - Phio Pharmaceuticals is currently enrolling patients for what is expected to be the fifth and final cohort in the Phase 1b study [5]. - The CEO of Phio Pharmaceuticals expressed optimism that the positive safety and efficacy outcomes suggest PH-762 could serve as a viable non-surgical alternative in the expanding skin cancer market [5][6]. Group 4: Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology, particularly in the field of immuno-oncology [6]. - The lead clinical program, PH-762, targets the PD-1 gene associated with various skin cancers, including cSCC, melanoma, and Merkel cell carcinoma [6].