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Core Viewpoint - Phio Pharmaceuticals has received a positive recommendation from the Safety Monitoring Committee to advance its clinical trial for PH-762, a siRNA compound targeting skin cancer, to the fifth dose escalation cohort, indicating a supportive safety profile through the fourth cohort [1][6]. Group 1: Clinical Trial Progress - The Phase 1b clinical trial (NCT 06014086) has enrolled five patients in the fourth cohort, with four diagnosed with cutaneous squamous cell carcinoma (cSCC) and one with Merkel cell carcinoma, all of whom tolerated the injections well without serious adverse events [2][4]. - A total of 15 patients have been treated across the first four cohorts, including 13 with cSCC, one with metastatic melanoma, and one with Merkel cell carcinoma [4]. - The company anticipates completing enrollment in the final cohort by the third quarter of 2025 [6]. Group 2: Efficacy and Safety Profile - Pathological responses at Day 36 showed a complete response (100% tumor clearance) in 4 out of 9 patients with cSCC, with one patient showing near complete response (>90% clearance) and another showing partial response (>50% clearance) [5]. - No patients exhibited clinical progression of disease, and the continuing favorable safety profile of PH-762 suggests it may be a well-tolerated treatment option for skin cancer [6][3]. Group 3: 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 [7][8]. - 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 [8].

Core Insights - Phio Pharmaceuticals is launching a strategic initiative to increase awareness of its INTASYL siRNA portfolio, which includes around 30 compounds [1][5] - The company reported positive interim safety and efficacy results for its INTASYL compound PH-762 in an ongoing Phase 1b clinical trial targeting skin cancer [1][5] Leadership Changes - Robert Infarinato has been appointed as VP of Strategic Development, effective June 9, 2025, transitioning from his role as CFO [2] - Lisa Carson has been named VP of Finance and Administration, bringing over 20 years of finance experience [2][4] Product Development - Phio's lead clinical program, PH-762, aims to silence the PD-1 gene associated with various skin cancers and is currently in a Phase 1b trial [5] - The ongoing trial evaluates PH-762 for treating cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, positioning it as a potential non-surgical treatment option [5]

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]

Core Insights - Phio Pharmaceuticals announced positive results from its Phase 1b clinical trial of PH-762, showing a complete pathologic response (100% tumor clearance) in 2 out of 3 patients with cutaneous squamous cell carcinoma (cSCC) in the third dose cohort [1][2][3] - The trial aims to evaluate the safety and tolerability of PH-762 as a neoadjuvant treatment for various stages of cSCC, melanoma, and Merkel cell carcinoma [2][7] - The ongoing trial has treated a total of 10 patients, with 4 achieving complete pathologic response and others showing varying degrees of tumor clearance [3][4] Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology [1][6] - The lead clinical program, PH-762, targets the PD-1 gene to enhance immune response against cancer cells [6] - The company plans to present trial results at the Society for Investigative Dermatology Annual Meeting on May 10, 2025 [6] Clinical Trial Details - The trial has not reported any dose-limiting toxicities or significant adverse effects, indicating a favorable safety profile for PH-762 [4][5] - The fourth cohort of the trial is currently enrolling patients, with expectations to complete enrollment by the third quarter of 2025 [4] - The positive pathologic responses observed in the trial support the potential of PH-762 as a non-surgical treatment option for skin cancers [2][5]

Core Insights - Phio Pharmaceuticals Corp. is a clinical-stage siRNA biotechnology company focused on developing therapeutics using its proprietary INTASYL® gene silencing technology to combat cancer [1][4] - The company announced podium presentations for its lead INTASYL product candidates, PH-762 and PH-894, at the 11th Annual Immunotherapy of Cancer (ITOC) Conference in Munich, Germany [1] Product Candidates - PH-762 is an INTASYL siRNA compound targeting PD-1, currently undergoing evaluation in an ongoing clinical trial (NCT 06014086) as a neoadjuvant intratumoral therapy for cutaneous malignancies, showing promising preclinical efficacy and favorable tolerability [2][4] - PH-894 selectively silences BRD4, enhancing NK cell activation and proliferation without off-target effects, representing a novel approach to improve adoptive cell therapy [3] Conference Presentations - Melissa Maxwell, Phio's Director of Research and Program Management, will present on PH-762 during the Plenary Session 3, focusing on its preclinical advances and ongoing clinical evaluation [2] - PH-894 will be discussed in Plenary Session 11, highlighting its potential to increase NK cell activity for adoptive cell therapy [3]