Prelude Therapeutics Reports Full Year 2025 Financial Results and Provides Program Outlook for 2026

Core Insights - Prelude Therapeutics has received FDA clearance for the Investigational New Drug (IND) application for PRT12396, a mutant-selective JAK2V617F inhibitor, with a Phase 1 study expected to start in Q2 2026 [1][4] - The company is also advancing PRT13722, a highly-selective oral KAT6A degrader, with an IND filing anticipated in mid-2026 and Phase 1 study initiation planned for the second half of 2026 [1][5] - Prelude's current cash runway is projected to last into Q2 2027, with $106 million in cash and equivalents as of December 31, 2025 [1][14] R&D Pipeline Updates - The JAK2V617F mutation is a significant driver in myeloproliferative neoplasms (MPNs), affecting approximately 95% of polycythemia vera patients, 60% of essential thrombocythemia patients, and 55% of myelofibrosis patients [3] - Prelude has developed novel allosteric inhibitors targeting the JAK2 JH2 "deep pocket" where the V617F mutation resides, showing potential to reduce mutant allele burden and improve treatment outcomes for MPN patients [3] - The KAT6A oral degrader program targets ER+ breast cancer, with the potential for improved efficacy and tolerability compared to non-selective inhibitors [5] Financial Performance - For the year ended December 31, 2025, Prelude reported a net loss of $99.5 million, or $1.29 per share, a decrease from a net loss of $127.2 million, or $1.68 per share, in the previous year [17][21] - Research and development expenses decreased to $94.3 million from $118.0 million in the prior year, attributed to reduced stock-based compensation and discontinued clinical trials [15] - General and administrative expenses also decreased to $22.4 million from $28.7 million, primarily due to lower stock-based compensation and employee-related expenses [16] Upcoming Milestones - The Phase 1 study of PRT12396 will be an open-label, multi-center trial focusing on patients with high-risk polycythemia vera and intermediate to high-risk myelofibrosis [4] - Prelude plans to present initial preclinical data for its KAT6A program at upcoming conferences, showcasing its commitment to advancing its R&D pipeline [6][11] - The company will participate in the Citizens Life Sciences Conference on March 10, 2026, where key executives will discuss the company's strategic direction and upcoming milestones [12]