Phio Pharmaceuticals Reports 2025 Year-End Financial Results and Business Update

Core Insights - Phio Pharmaceuticals has completed the treatment phase for its lead clinical candidate PH-762, showing favorable safety, tolerability, and pathology data [1][2] - The company has strengthened its balance sheet with $23.7 million in net proceeds from financings and warrant exercises, extending its cash runway into the first half of 2027 [1][5] Clinical Development - PH-762 is being evaluated in a Phase 1b dose-escalating clinical trial for patients with cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma, with a total of 22 patients enrolled [2] - The trial aims to assess the safety and tolerability of PH-762 and determine the appropriate dose for further studies, with an FDA submission planned for Q2 2026 [2] Corporate Updates - In July 2025, Phio entered into a drug substance development services agreement with a US manufacturer for the cGMP manufacture of PH-762, supporting future clinical development [3] - A development services agreement was also established in December 2025 for a non-clinical toxicology study required by the FDA before pivotal human trials [4] Financial Performance - As of December 31, 2025, Phio reported cash and cash equivalents of approximately $21.0 million, a significant increase from $5.4 million in 2024 [8] - Research and development expenses rose by 27% to $4.6 million, driven by advancements in the PH-762 program and increased employee compensation [9] - General and administrative expenses increased by 23% to $4.6 million, attributed to higher professional services and stock-based compensation [10] - The net loss for 2025 was approximately $8.7 million, or ($1.45) per share, compared to a net loss of $7.2 million, or ($9.08) per share in 2024 [11][16] Patent Portfolio - Phio's patent portfolio consists of 54 issued patents, with 49 covering the INTASYL platform, including 27 related to immuno-oncology compounds [6] - There are 20 pending patent applications that could enhance the company's therapeutic offerings, with potential expiration dates ranging from 2029 to 2044 [6] Scientific Engagement - In 2025, Phio presented new data on PH-762 at several prominent conferences, including AACR and SITC, and was invited to present at the AAD [7]