WILMINGTON, DE — Prelude Therapeutics Inc. (Nasdaq: PRLD) reported its financial results for the year ended December 31, 2025, and provided updates on its oncology drug development pipeline, including regulatory clearance for a new clinical program.
The company said the U.S. Food and Drug Administration cleared its investigational new drug application for PRT12396, a mutant-selective JAK2V617F inhibitor, in the first quarter of 2026.
Prelude expects to begin a Phase 1 clinical study of the drug in patients with polycythemia vera and myelofibrosis in the second quarter of 2026.
Chief Executive Officer Kris Vaddi said the company remains focused on advancing two core programs.
“Since the announcement of our strategic shift in November of 2025, our team continues to operate with a clear focus on steady execution on our JAK2V617F inhibitor and KAT6 degrader programs,” Vaddi said.
Prelude also said it is advancing development of PRT13722, an oral KAT6A degrader being studied as a potential treatment for estrogen receptor-positive breast cancer.
The company plans to file an investigational new drug application for PRT13722 in mid-2026 and begin a Phase 1 study in the second half of the year.
Prelude is also conducting research into targeted protein degradation therapies and antibody conjugate technologies through collaborations including an expanded partnership with AbCellera Biologics.
As of December 31, 2025, the company reported $106.4 million in cash, cash equivalents, restricted cash and marketable securities.
Prelude said it expects its existing cash resources to fund operations into the second quarter of 2027.
Research and development expenses totaled $94.3 million in 2025, down from $118.0 million in 2024.
General and administrative expenses declined to $22.4 million from $28.7 million the previous year.
The company reported a net loss of $99.5 million, or $1.29 per share, for 2025 compared with a net loss of $127.2 million, or $1.68 per share, in 2024.
Prelude Therapeutics is a clinical-stage biotechnology company focused on developing targeted therapies for cancer.
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