Phio Pharmaceuticals Announces Completion of Enrollment in Phase 1b Clinical Trial of INTASYL siRNA Lead Compound PH-762November 25, 2025 11:30 AM EST | Source: Phio Pharmaceuticals Corp.King of Prussia, Pennsylvania--(Newsfile Corp. - November 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today the completion of enroll ...

Core Insights - Phio Pharmaceuticals Corp. is set to present its INTASYL siRNA drug technology at the Advanced Therapies USA 2025 Congress, highlighting its potential in cancer treatment [1][2] - The INTASYL technology aims to down-regulate gene expression, with a specific focus on the PH-762 compound for treating cutaneous carcinomas [2][3] Company Overview - Phio Pharmaceuticals is a clinical-stage siRNA biopharmaceutical company that specializes in immuno-oncology therapeutics using its proprietary INTASYL® gene silencing technology [3] - The lead clinical program, PH-762, targets the PD-1 gene associated with various skin cancers and is currently undergoing a Phase 1b trial for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [3] Presentation Details - The podium presentation titled "INTASYL® Synthesized siRNA Drug Technology" will take place on November 18, 2025, at 1:15 PM EDT in the Innovation Showcase at the Pennsylvania Convention Center [2] - Melissa Maxwell, M.S., will be the presenting author, emphasizing the significance of INTASYL technology in enhancing cancer treatment [2]

Financial Performance - Total current assets increased to $11,493,000 as of September 30, 2025, compared to $5,736,000 on December 31, 2024, representing a growth of 100%[10] - The net loss for the nine months ended September 30, 2025, was $6,327,000, compared to a net loss of $5,524,000 for the same period in 2024, indicating a 15% increase in losses[13] - The company reported total operating expenses of $6,686,000 for the nine months ended September 30, 2025, a 17% increase from $5,713,000 in the same period of 2024[13] - The Company reported a net loss of $2.392 million for the three months ended September 30, 2025, compared to a net loss of $1.524 million for the same period in 2024, representing a 57% increase in net loss year-over-year[74] - Total operating expenses for the nine months ended September 30, 2025, were $6.686 million, up from $5.713 million in the same period of 2024, indicating an increase of 17%[74] Cash and Financing Activities - Cash and cash equivalents at the end of the period were $10,705,000, up from $5,390,000 at the end of September 30, 2024, reflecting a 98% increase[16] - The Company raised approximately $900,000 from the December 19, 2024 Offerings after deducting placement agent fees and offering expenses[45] - The net proceeds from the July 2025 Financing were approximately $2.1 million after deducting fees and expenses[57] - Net cash used in operating activities for the nine months ended September 30, 2025, was $5,900,000, slightly higher than $5,741,000 for the same period in 2024[16] - Net cash provided by financing activities for the nine months ended September 30, 2025, was $11.2 million, an increase from $2.6 million in 2024, mainly due to the issuance and exercise of common stock and warrants[117] Research and Development - Research and development expenses for the three months ended September 30, 2025, were $1,181,000, up 83% from $644,000 in the same period of 2024[13] - Research and development expenses for the nine months ended September 30, 2025, totaled $3.141 million, compared to $2.658 million for the same period in 2024, reflecting a 18% increase[74] - The ongoing Phase 1b clinical trial for PH-762 has shown promising results, with 100% tumor clearance in one of three patients and over 90% clearance in another at Day 36[87] - A total of 18 patients with cutaneous carcinomas completed treatment in the Phase 1b trial, with 6 achieving a complete response (100% clearance) and 2 showing near complete response (>90% clearance) [88] - Preclinical data indicated that PH-762 treated DP TIL increased tumor killing activity by two-fold in collaboration with AgonOx [90] Stock and Equity - Total stockholders' equity rose to $9,839,000 as of September 30, 2025, compared to $4,723,000 at the end of 2024, marking a 108% increase[10] - The weighted average number of common shares outstanding increased to 5,468,584 for the three months ended September 30, 2025, compared to 990,033 in the same period of 2024[13] - The Company issued 2,507,005 shares of common stock and warrants, net of offering costs of $1,028,000, during the reporting period[14] - The Company completed a 1-for-9 reverse stock split effective July 5, 2024, adjusting all share and per share amounts accordingly[25] Operational Challenges - The Company has reported recurring losses from operations since inception and expects to continue negative cash flows for the foreseeable future[27] - The Company has not yet recognized any product revenues, raising doubts about its ability to continue as a going concern[28] - The Company anticipates incurring substantial additional operating losses for several years as it continues to develop product candidates and seek marketing approval[119] - Future funding requirements may be influenced by various factors, including investments in research and development, clinical trial expenses, and potential strategic acquisitions[121] - The company may seek additional funding to sustain future operations, but there is no assurance that such funding will be available on favorable terms[122] Compliance and Regulatory Risks - The company is currently in compliance with Nasdaq listing requirements, but there is no guarantee of maintaining compliance in the future[132] - Changes in U.S. and international trade policies may adversely impact the company's business and operating results, particularly regarding supply chain disruptions and increased costs[134]

Financial Performance - Phio Pharmaceuticals reported a net loss of $2.4 million for Q3 2025, compared to a net loss of $1.5 million in Q3 2024, reflecting an increase in operating expenses[12]. - Total operating expenses for Q3 2025 were $2.5 million, compared to $1.6 million in Q3 2024[20]. Research and Development - Research and development expenses increased to $1.2 million in Q3 2025 from $0.6 million in Q3 2024, primarily due to higher clinical trial costs[10]. - In the ongoing Phase 1b trial of PH-762, 100% tumor clearance was achieved in one patient, with over 90% clearance in another and over 50% in a third patient[2]. - A total of 18 patients have completed treatment in the Phase 1b trial, with 6 achieving complete response and 2 achieving near complete response[3]. - The company has no reported dose-limiting toxicities or clinically relevant adverse effects in patients receiving PH-762[4]. Cash and Assets - As of September 30, 2025, the company had cash and cash equivalents of approximately $10.7 million, up from $5.4 million at December 31, 2024[9]. - The company’s total assets increased to $11.5 million as of September 30, 2025, compared to $5.7 million at December 31, 2024[22]. Future Financing - The company expects to raise approximately $12.1 million from warrant inducement financing, extending its cash runway into the first half of 2027[8]. Operating Expenses - General and administrative expenses rose to $1.3 million in Q3 2025, up from $0.9 million in Q3 2024, driven by increased professional fees and employee stock compensation[11].

Core Insights - Phio Pharmaceuticals reported positive clinical trial results for its lead compound PH-762, achieving 100% tumor clearance in one patient and over 90% clearance in another patient in the fifth cohort of its Phase 1b trial [1][2][3] - The company secured approximately $12.1 million in net proceeds from warrant inducement financing, extending its cash runway into the first half of 2027 [1][9] - Financial results for Q3 2025 showed a net loss of $2.4 million, an increase from $1.5 million in Q3 2024, primarily due to higher research and development expenses [1][13] Clinical Trial Progress - The ongoing Phase 1b trial is evaluating the safety and tolerability of PH-762 in patients with various stages of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [2][15] - As of now, 18 patients have completed treatment across five cohorts, with cumulative results indicating six complete responses and two near-complete responses among patients with cutaneous squamous cell carcinoma [3][4] Financial Overview - As of September 30, 2025, the company had cash and cash equivalents of approximately $10.7 million, up from $5.4 million at the end of 2024, with an estimated total of $21.3 million post-financing [10][20] - Research and development expenses for Q3 2025 were $1.2 million, compared to $0.6 million in the same period of 2024, driven by increased clinical trial costs [11] - General and administrative expenses rose to $1.3 million in Q3 2025 from $0.9 million in Q3 2024, attributed to higher professional fees and employee stock compensation [12] Business Developments - The company entered into a drug substance development services agreement with a U.S. manufacturer for the cGMP production of clinical supplies for PH-762 in July 2025 [5] - Phio has actively engaged in scientific and investor presentations to showcase its INTASYL technology and clinical trial results [7]

Core Insights - Phio Pharmaceuticals is set to present clinical data from its ongoing Phase 1b trial of siRNA-based INTASYL PH-762 for skin cancer at the 40th Annual Meeting of the Society for Immunotherapy of Cancer [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][4] - The company's lead clinical program, PH-762, targets the PD-1 gene, which is implicated in various forms of skin cancer, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [4] Clinical Trial Details - The ongoing Phase 1b clinical trial is designed to evaluate the safety and tolerability of intratumoral injection of PH-762 in patients with specific skin cancers [2][4] - The trial is registered under NCT 06014086 and aims to assess PH-762 as a potential non-surgical treatment option for skin cancers [4] Presentation Information - The poster presentation titled "PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinomas: A Clinical Study of INTASYL PH-762" will be presented by Mary Spellman, M.D. on November 8, 2025 [3]

Core Insights - Phio Pharmaceuticals' INTASYL compound PH-762 has been awarded the 2025 Immunomodulatory Solution of the Year by the BioTech Breakthrough Awards Program, highlighting its significance in cancer treatment [1][2][3] Company Overview - Phio Pharmaceuticals Corp. is a clinical-stage biopharmaceutical company focused on developing therapeutics using its proprietary INTASYL® siRNA gene silencing technology aimed at eliminating cancer [1][4] - The company's lead clinical program, PH-762, targets the PD-1 gene associated with various skin cancers and is currently undergoing a Phase 1b trial for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [4] Industry Recognition - The BioTech Breakthrough Awards program is an independent initiative that recognizes outstanding achievements in life sciences and biotechnology globally, with a focus on innovative solutions and products [2][9] - The award received by PH-762 underscores its potential as a non-surgical treatment option for patients with cutaneous carcinomas, addressing a significant medical need [3]

Core Viewpoint - Phio Pharmaceuticals Corp. has announced the exercise of warrants that will generate approximately $13.4 million in gross proceeds, aimed at advancing its clinical development activities for its lead product, PH-762, targeting skin cancers [1][4]. Group 1: Warrant Exercise Details - The company has entered into agreements to exercise warrants for a total of 5,663,182 shares of common stock, with exercise prices ranging from $2.00 to $5.45 per share [1]. - The exercise includes 60,000 shares at $2.00, 948,596 shares at $2.485, and 4,654,586 shares at a reduced price of $2.05 [1]. - The gross proceeds from these exercises are expected to be around $13.4 million before deducting fees and expenses [1]. Group 2: New Warrants and Offerings - In exchange for the immediate cash exercise of the warrants, holders will receive new unregistered warrants to purchase up to 8,855,248 shares of common stock [3]. - The offering will occur in two closings, with the first expected on or about November 4, 2025, and the second by November 18, 2025 [3]. - The new warrants will have an exercise price of $2.05 per share and will be immediately exercisable for a term of twenty-four months [3]. Group 3: Use of Proceeds - The net proceeds from the warrant exercises will primarily be used for working capital and to accelerate the completion of development activities for PH-762, following positive trial outcomes [4]. Group 4: Company Overview - Phio Pharmaceuticals Corp. is a clinical-stage siRNA biopharmaceutical company focused on immuno-oncology therapeutics, utilizing its INTASYL® gene silencing technology [8]. - The lead clinical program, PH-762, targets the PD-1 gene and is currently in a Phase 1b trial for treating various skin cancers [8].

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 appointed Mr. David H. Deming as Lead Independent Director, bringing over 30 years of experience in investment banking and asset management to the role [1][2][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 eliminating cancer [1][4] - The company's lead clinical program is PH-762, which targets the PD-1 gene associated with various skin cancers and is currently undergoing a Phase 1b trial for cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [4] Leadership Experience - Mr. Deming has a significant background in investment banking, having spent over 27 years at JP Morgan, where he led the Health Group in investment banking for the last 12 years of his tenure [2] - His experience in the biopharma sector and corporate boards is expected to provide valuable insights as Phio advances its gene silencing technology [3]