Prelude Therapeutics Gets FDA IND Clearance for JAK2 Inhibitor, Reports $106M Cash Runway
Prelude Therapeutics received FDA clearance for its mutant-selective JAK2V617F inhibitor PRT12396 and plans to initiate a Phase 1 trial by Q2 2026. The company holds $106.4 million in cash and equivalents, funding operations into Q2 2027 with R&D expenses declining from $118 million to $94.3 million in 2025.
1. Full Year 2025 Financial Results
Prelude closed 2025 with $106.4 million in cash, cash equivalents, restricted cash and marketable securities, providing funding into the second quarter of 2027. R&D expenses decreased to $94.3 million from $118.0 million, reflecting cost efficiencies following its strategic shift in November 2025.
2. IND Clearance for PRT12396
The FDA cleared the IND for PRT12396, Prelude’s lead mutant-selective JAK2V617F inhibitor, enabling initiation of an open-label, multi-center Phase 1 trial in high-risk polycythemia vera and myelofibrosis patients in Q2 2026. This program operates under an exclusive option agreement with Incyte.
3. KAT6A Degrader Program Outlook
Prelude’s highly selective oral KAT6A degrader candidate, PRT13722, is in preclinical development with IND enabling studies underway and plans to file an IND by mid-2026, aiming to start Phase 1 in the second half of 2026. The approach targets improved efficacy and tolerability in ER+ breast cancer.