Phio Pharmaceuticals to Present at the H.C. Wainwright 27th Annual Global Investment ConferenceSeptember 03, 2025 7:45 AM EDT | Source: Phio Pharmaceuticals Corp.Clinical trial advances to anticipated final cohort for INSTASYL siRNA lead product candidate PH-7625th cohort patients now being treated in on-going clinical studyKing of Prussia, Pennsylvania--(Newsfile Corp. - September 3, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing the ...

Core Insights - Phio Pharmaceuticals reported its financial results for Q2 2025 and provided updates on its clinical trials, particularly for its lead product candidate PH-762, which utilizes INTASYL siRNA technology to target cancer treatment [1][4]. Clinical Progress - The ongoing Phase 1b clinical trial for PH-762 is evaluating its safety and tolerability in patients with various stages of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, with 15 patients treated across four cohorts [2][4]. - No dose-limiting toxicities or significant adverse effects have been reported, and all patients tolerated the treatment well, with no clinical progression observed during the trial [2][3]. Efficacy Results - Among the 13 patients with cutaneous squamous cell carcinoma, five achieved complete response (100% clearance), one had near complete response (>90% clearance), one had partial response (>50% clearance), and six had pathologic non-response (<50% clearance) [3]. - The patient with stage 4 metastatic Merkel cell carcinoma showed a pathological partial response (>50% clearance), while the melanoma patient did not respond (<50% clearance) [3]. Financial Overview - As of June 30, 2025, the company had cash and cash equivalents of approximately $10.8 million, an increase from $5.4 million at the end of 2024 [8]. - Research and development expenses for Q2 2025 were $1.1 million, up from $0.9 million in Q2 2024, primarily due to increased patient enrollment and higher consulting costs [9]. - General and administrative expenses for Q2 2025 were $1.2 million, compared to $1.0 million in the same period last year, driven by increased salary-related costs [11]. Net Loss - The net loss for Q2 2025 was $2.2 million, compared to $1.8 million in Q2 2024, attributed to rising research and development and administrative expenses [13]. Stockholder Equity - Total stockholders' equity increased to $10.1 million as of June 30, 2025, from $4.7 million at the end of 2024, reflecting the company's capital raising efforts [20][21].

Core Insights - Phio Pharmaceuticals has entered into a comprehensive drug substance development services agreement with a U.S. manufacturer for its lead compound PH-762, which is a significant step in advancing its intratumoral program for treating cutaneous carcinomas [1][2] - The company is currently enrolling patients for the fifth and expected final cohort in its Phase 1b dose escalation study targeting cutaneous squamous cell carcinoma, Merkel cell carcinoma, and melanoma [1][2] 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 eliminating cancer [1][2] - The lead clinical program, PH-762, is designed to silence the PD-1 gene, which is implicated in various forms of skin cancer, and represents a potential non-surgical treatment option [2]

Core Insights - Phio Pharmaceuticals reported financial results for Q1 2025, highlighting advancements in its clinical trials for the siRNA lead product candidate PH-762, which aims to enhance immune cell effectiveness against cancer [1][2] Clinical Progress - The ongoing Phase 1b trial for PH-762 is evaluating its safety and tolerability in patients with various stages of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [2] - As of now, 10 patients have been treated across the first three cohorts, with 4 patients achieving a pathologic complete response, indicating 100% tumor clearance [3][4] Financial Results - At March 31, 2025, the company had cash of approximately $13.3 million, a significant increase from $5.4 million at December 31, 2024 [11] - Net cash provided by financing activities for Q1 2025 was approximately $9.2 million, compared to a net cash usage of approximately $4,000 in Q1 2024 [12] - Research and development expenses decreased by 23% to $0.886 million in Q1 2025 from $1.148 million in Q1 2024, primarily due to reduced salary-related costs and consulting expenses [13] - General and administrative expenses also saw a decrease of 7%, from approximately $1.061 million in Q1 2024 to approximately $0.986 million in Q1 2025 [14] - The net loss for Q1 2025 was $1.8 million, down from $2.2 million in Q1 2024, attributed to reduced operating expenses [15] Capital Sourcing - In late 2024 and early 2025, Phio raised approximately $9.2 million through registered direct offerings and private placements, along with an additional $2.9 million from warrant exercises, providing sufficient capital to complete the treatment phase of the Phase 1b trial [8] Cost Rationalization - The company has transitioned to a new laboratory facility with a monthly rent of approximately $2,500, and has contracted for additional working space at a fee of $300 per month [9]