PH-762 TME / Phio Pharma - LARVOL DELTA

Phio announced today that, following the formal completion of the Phase 1b clinical study, it has submitted a meeting request and comprehensive briefing package to the U.S. Food and Drug Administration (FDA). (Newsfile) - "The submission describes the nonclinical development program and integrated clinical pharmacology data for PH-762 and provides details of the completed Phase 1b study as well as the next planned Phase 2b neoadjuvant clinical study in cutaneous squamous cell carcinoma....Phio is currently preparing to manufacture clinical supplies for the next planned study, which are expected to be available in the first quarter of 2027. In addition, the dosing phase of the company's nonclinical toxicology study has been completed. Final activities supporting the next phase of clinical development are expected to be completed during the first quarter of 2027."

FDA event • New P2b trial • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Strategic milestone advancements for lead clinical candidate PH-762 (Phio Pharma Press Release) - "The trial (NCT06014086) was designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762, assess the tumor response, and determine the dose or dose range for continued study of PH-762. The study comprised 22 patients, including 20 with cutaneous squamous cell carcinoma, one with melanoma and one with Merkel cell carcinoma, which was completed in March of this year. Final comprehensive clinical study documentation is in final preparation stage, which will be submitted to the FDA. Phio intends to request an FDA meeting in the third quarter of 2026 to discuss next steps in the clinical trial design and development strategy for PH-762."

FDA event • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals announced today that Robert Bitterman, CEO and Chairman of the Board, will present an overview of the Company's INTASYL siRNA platform, including its lead clinical candidate PH-762 for the treatment of cutaneous carcinomas (TradingView)

Clinical data • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Presentation at Centri Capital Conference on April 14, 2026 (Phio Pharma Press Release) - "During the session, Mr. Bitterman will discuss Phio’s recent clinical progress and future growth strategy, with a focus on the potential of INTASYL as a novel and differentiated approach in the field of immuno-oncology. 'We are excited to participate in the Centri Capital Conference and discuss why we believe that INTASYL PH-762 represents a paradigm shift in the treatment of cutaneous squamous cell carcinoma (cSCC)'."

Clinical data • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces American Academy of Dermatology 2026 Presentation Featuring Clinical Study Results from Study of PH-762 for Cutaneous Carcinoma Underscoring Clinical Pipeline Advancement (Phio Pharma Press Release) - "The presentation, entitled 'PD-1 Directed Intratumoral Immunotherapy: Results of an Escalating Dose Study of INTASYL PH-762 for Cutaneous Carcinomas', will highlight results of Phio’s Phase 1b clinical study (NCT 06014086) which evaluated the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma (cSCC), melanoma and Merkel cell carcinoma."

P1 data • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

PD-1 Directed Intratumoral Immunotherapy: Results of an Escalating Dose Study of INTASYL PH-762 for Cutaneous Carcinomas (AAD 2026) - No abstract available

Late-breaking abstract • Oncology • Skin Cancer

Phio announced today that the Safety Monitoring Committee (SMC) has concluded its planned safety review for all patients treated with the INTASYL compound PH-762 in Phio’s Phase 1b clinical trial. (Phio Pharma Press Release) - "While final study data is pending formal analysis, an FDA submission intended to propose and seek guidance for next steps in clinical study design for PH-762 is targeted for the second quarter of 2026....Among the 20 patients with cSCC, 13 patients were classified as pathologic responders, including 9 patients with complete response (100% clearance), 2 patients with major/near clear response (greater than 90% clearance), and 2 patients with partial response (greater than 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response. Seven cSCC patients and one melanoma patient had responses of less than 50%, however, none of the patients experienced a progression of the disease."

Clinical protocol • P1 data • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Key Tumor Response Data from all Cohorts in Intratumoral PH-762 Dose Escalation Cutaneous Carcinoma Trial (Phio Pharma Press Release) - "A total of 22 patients with cutaneous carcinomas completed treatment across five cohorts in the Phase 1b trial and underwent excision of the treated lesional site. Among the 20 patients with cSCC, 14 patients were determined to be pathologic responders, including 10 patients with complete response (100% clearance), 2 patients with major/near clear response (greater than 90% clearance), and 2 patients with partial response (greater than 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response with greater than 50% clearance. Six cSCC patients and one melanoma patient had responses of less than 50%, however, none of the patients experienced a progression of the disease."

P1 data • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Participation in the Sidoti Micro-Cap Virtual Investor Conference January 21-22, 2026 (Phio Pharma Press Release) - "Phio announced today that Mr. Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals will present an update on the company’s proprietary INTASYL siRNA technology and progress on the on-going clinical trial with lead compound PH-762 for treatment of skin cancers."

Clinical • Melanoma

Phio Pharmaceuticals Announces Significant Step Forward in its Drug Development Program for PH-762 (Newsfile) - "Nonclinical protocol study design accepted by FDA...The company will begin a toxicology study, which is required by the FDA prior to commencing a human pivotal trial. Concurrently, initiatives are continuing to advance the delivery of commercially viable drug product in 2026 that meets FDA's current Good Manufacturing Practices."

Commercial • Preclinical • Solid Tumor

Recently, positive interim safety and efficacy results were reported in the on-going Phase 1b dose escalation clinical trial with the INTASYL compound PH-762 for the treatment of skin cancer. (Newsfile) - "To date, a total of 18 patients with cutaneous carcinomas have completed treatment across five dose escalating cohorts in the Phase 1b trial. The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance)....To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort."

P1 data • Melanoma • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio announced today the completion of enrollment in its ongoing Phase 1b clinical trial of INTASYL siRNA PH-762 (Phio Pharma Press Release) - "In connection with completing enrollment, Phio continues to treat additional patients in the fifth cohort at the highest dose concentration of PH-762. Pathology results for these patients are expected in Q1 2026."

P1 data • Trial status • Cutaneous Melanoma • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Positive Pathology Results: Final Maximum Dose Cohort for INTASYL PH-762 Skin Cancer Trial (FinancialContent) - "The cumulative pathologic response in 16 patients with cSCC include six with a complete response (100% clearance), two with a near complete response (> 90% clearance) and two with a partial response (> 50% clearance). A single patient with metastatic Merkel cell carcinoma had a partial response (> 50% clearance). Six patients with cSCC and one patient with metastatic melanoma had a pathologic non-response (< 50% clearance)....In addition, the Safety Monitoring Committee (SMC) completed its pre-specified review of safety results for the first three patients in the fifth cohort and confirmed that there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects at this maximum dose concentration."

DSMB • P1 data • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

PD-1–directed intratumoral immunotherapy for cutaneous carcinomas: A clinical study of INTASYL PH-762 (SITC 2025) - P1 | "Patients receive IT PH-762 once weekly, 4 times over a 3-week period prior to surgical excision, which occurs 5 weeks after the initial injection. Tumor changes are evaluated per iRECIST criteria and pathological response.Trial Registration Clinicaltrials.gov: NCT 06014086Ethics Approval This study was approved by Advarra Institutional Review Board (00023875)."

Clinical • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • IFNG

Phio Pharmaceuticals to Present at the Life Sciences Future Conference (Phio Pharma Press Release) - "Mr. Robert Bitterman...will deliver an update on its on-going Phase 1b clinical trial for skin cancer. He will also be discussing strategy and anticipated next steps in the PH-762 development program upon completion of the treatment phase of the study."

P1 data • Pipeline update • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Pathology Results for Four of Five Patients in Fourth Cohort (Phio Pharma Press Release) - P1 | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "Phio announced today that pathologic results are available for four of the five patients treated in the fourth cohort. A complete pathologic response (100% tumor clearance) has been reported for one patient with cutaneous squamous cell carcinoma (cSCC). One patient with metastatic Merkel cell carcinoma was reported as a partial response (> 50% clearance). Two patients with cSCC were reported as having a pathologic non-response (90% clearance) and one with a partial response (>50% clearance) and six patients with a pathologic non-response (< 50% clearance)."

P1 data • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Agreement with U.S. Manufacturing Source for Drug Substance (Newsfile) - "Phio Pharmaceuticals...today it has entered into a comprehensive drug substance development services agreement with a U.S. manufacturer. The company will provide analytical and process development and cGMP manufacture of Phio's lead clinical development compound PH-762. This represents a critical next step in advancing Phio's intratumoral program to treat cutaneous carcinomas. Phio is currently enrolling patients for the 5th and expected final cohort in its Phase 1b dose escalation study for cutaneous squamous cell carcinoma, Merkel cell carcinoma and melanoma."

Commercial • Trial status • Melanoma • Merkel Cell Carcinoma • Squamous Cell Carcinoma

Phio Pharmaceuticals Announces Positive Safety Monitoring Committee Recommendation to Advance INTASYL PH-762 Skin Cancer Clinical Trial to Fifth Dose Escalation Cohort (Phio Pharma Press Release) - "Phio announced...that the Safety Monitoring Committee (SMC) recommended dose escalation in its Phase 1b clinical trial designed to evaluate the safety and tolerability of intratumoral (IT) PH-762 in the treatment of Stages 1, 2, and 4 cutaneous squamous cell carcinoma (cSCC), Stage 4 melanoma, and Stage 4 Merkel cell carcinoma...Five patients were enrolled in the fourth cohort of the Phase 1b clinical trial (NCT 06014086). Four of the enrolled patients were diagnosed with cSCC and one patient with Merkel cell carcinoma. As with the previous three cohorts, injections were well-tolerated and there were no dose-limiting toxicities, serious adverse events, or clinically relevant treatment-emergent adverse reactions reported...To date, a total of 15 patients with cutaneous carcinomas have been treated with PH-762 in Cohorts 1 through 4. These cohorts included 13 patients with cSCC, one patient with metastatic melanoma, and one patient with Merkel cell carcinoma."

DSMB • P1 data • Trial status • Cutaneous Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Business Update (Phio Pharma Press Release) - P1 | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "To date, a total of 10 patients with cutaneous carcinomas have been treated in Cohorts 1, 2 and 3. These cohorts included 9 patients with cSCC and 1 patient with metastatic melanoma. At Day 36 (planned tumor excision), of the 9 patients with cSCC, 4 patients had a pathologic complete response (100% tumor clearance). One patient had a near complete response (>90% clearance) and 1 patient had a partial response (>50% clearance). The other 3 cSCC and one metastatic melanoma patient had a pathologic non-response (< 50% clearance)....Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling and treating patients; Phio expects to complete enrollment in the trial in the third quarter of 2025."

Enrollment status • P1 data • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Positive Pathology Results in Third Cohort in INTASYL PH-762 Skin Cancer Clinical Trial (Phio Pharma Press Release) - P1 | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "Phio announced today that a complete pathologic response (100% tumor clearance) has been reported for 2 of 3 patients with cutaneous squamous cell carcinoma (cSCC) treated in the third dose cohort. The third patient was reported as having a pathologic non-response (<50% tumor clearance)....To date, there were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. The fourth cohort is currently enrolling patients; Phio expects to complete enrollment in the trial in the third quarter of 2025."

P1 data • Trial status • Melanoma • Merkel Cell Carcinoma • Skin Cancer • Squamous Cell Skin Cancer

Phio Pharmaceuticals Reports 2024 Year End Financial Results and Provides Business Update (Phio Pharma Press Release) - "PH-762 is currently being evaluated in a U.S. multi-center Phase 1b dose-escalating clinical trial through the intratumoral injection of PH-762 for the treatment of patients with cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma. The trial (NCT06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumorally injected PH-762 in up to 30 patients....To date, intratumoral injection of PH-762 has been well tolerated in all enrolled patients. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762. The third dose cohort is fully enrolled and patients in this cohort are currently in the treatment or follow-up phase of the study. Phio expects to complete enrollment of all patients in the study in the third quarter of 2025."

Trial status • Melanoma • Merkel Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study (Phio Pharma Press Release) - "Phio announced today that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating clinical study for their lead compound PH-762. The company plans to initiate screening of the fourth dose cohort in early April. Phio’s Phase 1b study (NCT06014086) is a multi-center, dose-escalating clinical trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This study assesses the tumor response and determines the recommended dose for further study of PH-762."

Trial status • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Announces Data Showcasing INTASYL’s Role in Helping Immune Cells Target and Kill Cancer Cells (Phio Pharma Press Release) - "Phio Pharmaceuticals Corp....today announced that it is presenting data about its proprietary INTASYL platform and INTASYL compounds....INTASYL compound PH-762 silences PD-1, improving therapeutic efficacy in vivo. The PH-894 compound precisely silences BRD4 to enhance tumor cell immunogenicity and induce apoptosis. Silencing TIGIT in NK cells, using compound PH-804, enhances their activation, cytokine release, and target cell killing. The PH-905 compound silences CBLB, increasing NK cell cytotoxicity and proliferation....The data is being presented on October 8th at the 20th Annual Oligonucleotide Therapeutics Society (OTS) Meeting in Montreal."

Preclinical • Oncology

Phio Pharmaceuticals Announces Addition of Clinical Trial Site for its Phase 1b study of PH-762 (Newsfile) - "Phio Pharmaceuticals Corp...announced the addition of the University of Pittsburgh Medical Center (UPMC) Department of Dermatology in Pittsburgh, PA as a clinical trial site for its lead product candidate, PH-762...The UPMC Department of Dermatology joins four other sites engaged in the clinical study: The George Washington University-Medical Faculty Associates in Washington, D.C; Banner MD Anderson Cancer Center in Gilbert, Arizona; Integrity Research Clinical Associates in Delray Beach, Florida; and Centricity Research in Dublin Ohio....The Phase 1b trial is a non-comparative study of neoadjuvant monotherapy using PH-762 in adult patients with cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma."

Trial status • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Positive Recommendation from Safety Monitoring Committee (SMC) of Phase 1b Clinical Study of Phio's Lead Compound PH-762 (Newsfile) - P1b | N=30 | NCT06014086 | Sponsor: Phio Pharmaceuticals Inc. | "Phio Pharmaceuticals Corp...announced that a Safety Monitoring Committee (SMC) reviewed safety data from the first dose cohort treated in the Phase 1b clinical trial with Phio's lead compound PH-762. Based on these findings, the SMC recommended the escalation to the next dose concentration...Phio's ongoing Phase 1b clinical study (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cutaneous squamous cell carcinoma, Stage 4 melanoma and Stage 4 Merkel cell carcinoma....There have been no dose-limiting toxicities, or clinically relevant treatment-emergent adverse events in the initial cohort receiving intratumoral PH-762. The intratumoral injections have been well tolerated. The SMC has recommended dose escalation and enrollment of the next planned cohort in the clinical study."

DSMB • P1 data • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor