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Phio Pharmaceuticals Corp. reports developments as a clinical-stage siRNA biopharmaceutical company advancing its proprietary INTASYL® gene-silencing technology for immuno-oncology. Company updates center on PH-762, an INTASYL compound designed to silence the PD-1 gene and evaluated as an intratumoral therapy for cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma.
Recurring news themes include PH-762 clinical results, safety and pathology data, nonclinical toxicology work, cGMP clinical-supply manufacturing, regulatory-development steps, financial results, equity financing activity and investor presentations. Coverage also reflects the company's use of self-delivering RNAi technology intended to enhance immune-cell activity against tumor cells without specialized formulation or delivery systems.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) has opened enrollment for the second cohort of its Phase 1b clinical study of PH-762 for advanced melanoma following a positive safety review by the Data Monitoring Committee (DMC). The FDA has confirmed the company can proceed with a planned Phase 1 clinical trial in advanced solid tumors in collaboration with AgonOx. Financially, Phio reported a decreased net loss of $11.5 million for 2022, down 14% from 2021, and a 21% reduction in R&D expenses to $7.0 million. As of December 31, 2022, the company had $11.8 million in cash, which is expected to support operations through Q4 2023.
Phio Pharmaceuticals (Nasdaq: PHIO) appointed Robert Bitterman as President and CEO, effective February 20, 2023. Bitterman has been serving as Interim CEO since September 2022 and will continue as Chair of the Board. The Board of Directors emphasized his strategic leadership and extensive experience as key factors for his appointment during this critical period for the company.
Bitterman stated his commitment to advancing Phio's clinical pipeline and achieving key milestones in 2023 and 2024. Phio specializes in immuno-oncology therapeutics, leveraging its proprietary INTASYL™ RNAi technology to enhance immune cell effectiveness against tumors.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced on February 13, 2023, that it has regained compliance with Nasdaq's minimum bid price listing requirement. The company has satisfied the Nasdaq Listing Qualifications Panel by ensuring its stock price meets the minimum threshold of $1.00 per share, thereby fulfilling all criteria for continued listing. This marks a significant milestone for Phio as it continues to advance its proprietary INTASYL™ RNAi platform, which enhances the efficacy of immune cells against tumor cells. The matter regarding compliance is now considered closed by Nasdaq.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced a positive recommendation from an independent Data Monitoring Committee following a review of safety data from its Phase 1b trial of PH-762, aimed at treating advanced melanoma. Conducted at the Gustave Roussy Institute in France, the trial showed no dose-limiting toxicity or severe adverse events, allowing for the continuation of patient enrollment. Phio plans to initiate a US Phase 1b trial targeting cutaneous squamous cell carcinoma in the latter half of 2023. The INTASYL™ RNAi platform aims to enhance immune cell effectiveness against tumor cells by inhibiting PD-1 expression.
Phio Pharmaceuticals Corp. (NASDAQ: PHIO) announced a 1-for-12 reverse stock split, effective January 26, 2023, to increase its share price above the minimum $1.00 bid for continued listing on The Nasdaq Capital Market. The outstanding shares will decrease from approximately 13.7 million to 1.1 million. The reverse split will be uniform for all shareholders, with no fractional shares issued—cash payments will be provided instead. This action aims to ensure compliance with Nasdaq's listing standards while maintaining shareholder percentage interests unchanged, barring fractional adjustments.
Phio Pharmaceuticals (Nasdaq: PHIO) announced that its Principal Executive Officer, Robert Bitterman, will present at the Entrepreneurial Showcase during the Dermatology Summit in San Francisco on January 8, 2023. He will highlight the company's proprietary INTASYL™ RNAi platform, which aims to enhance the effectiveness of immune cells against tumor cells. INTASYL is distinguished as the only self-delivering RNAi technology tailored for immuno-oncology therapeutics. Bitterman has a history of leading dermatological product development and commercialization.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) has received FDA clearance for its Phase 1 clinical trial targeting advanced solid tumors. Conducted in collaboration with AgonOx, Inc. and the Providence Cancer Institute, this trial will evaluate the safety and therapeutic potential of Phio’s PH-762 in combination with double positive CD8 tumor infiltrating lymphocytes (AGX148) for melanoma and other tumors. Preclinical data shows that PH-762 enhances tumor-killing activity of AGX148 two-fold. This milestone paves the way for future cancer therapies.
Phio Pharmaceuticals Corp. announced plans to file an IND for PH-762, its INTASYL™ compound, targeting cutaneous squamous cell carcinoma (cSCC). The Phase 1b clinical trial is expected to commence in the second half of 2023 following regulatory approval. PH-762 aims to address the unmet medical needs in treating cSCC, which comprises 51% of solid tumors in the U.S. The company emphasizes its unique RNAi technology's potential to enhance T cell functionality against tumors, positioning PH-762 as a promising option for patients unresponsive to existing monoclonal antibody therapies.
Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced new leadership appointments and reported Q3 2022 financial results. The company continues enrollment in its Phase 1b study of PH-762 for advanced melanoma. New executives, including Robert Bitterman as Executive Chairman, aim to advance Phio's proprietary INTASYL™ platform, enhancing immuno-oncology therapies. Cash reserves stand at $14.5 million, expected to fund operations for at least 12 months. Q3 net loss decreased to $3.6 million, with R&D expenses down 6% year-over-year.
Phio Pharmaceuticals (Nasdaq: PHIO) recently announced promising results from studies of its INTASYL™ compounds at the 37th Annual Meeting of the Society for Immunotherapy of Cancer. These compounds target multiple proteins, showing preclinical activity in Direct-to-Tumor and Adoptive Cell Therapy applications. Notable compounds included PH-762, PH-894, and PH-109, all of which demonstrated significant potential in enhancing T cell activity against tumor cells. The company expects to report topline safety data for PH-762 in early Q1 2023.