King of Prussia, Pennsylvania--(Newsfile Corp. - January 26, 2026) - 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 announced that it will participate in the DealFlow Discovery Conference, taking place January 28-29, 2026 at the Borgata Hotel in Atlantic City, NJ.Robert Bitterman, CEO and Chairman of the Board of Phio Pharmaceuticals will ...

Pathology data indicate 70% overall response rate for squamous cell carcinomas: 100% clearance in 10 out of 14 responders Favorable safety and tolerability at all dose escalations King of Prussia, Pennsylvania--(Newsfile Corp. - January 20, 2026) - 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 a summary of the pathology results and safety ...

Core Insights - 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 company is currently conducting a Phase 1b clinical trial for its lead compound PH-762, aimed at treating various forms of skin cancer, including cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma [4] Company Presentation - CEO Robert Bitterman will present an update on the INTASYL siRNA technology and the ongoing clinical trial for PH-762 on January 22, 2026, at 1:45 PM ET [2] - Investors are invited to register for one-on-one meetings with the CEO during the conference from January 21 to January 22, 2026 [2] Company Background - Phio Pharmaceuticals is advancing its INTASYL technology, which is designed to enhance the immune system's ability to target and kill cancer cells [4] - The lead clinical program, PH-762, specifically silences the PD-1 gene, which is implicated in skin cancer [4]

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]

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]