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Fulcrum Therapeutics
Fulcrum Therapeutics (FULC) investor relations material
Fulcrum Therapeutics Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary24 Feb, 2026
Executive summary
12-week data from the 20-mg cohort of the phase I-B PIONEER trial in sickle cell disease showed rapid and robust induction of fetal hemoglobin (HbF), with a mean absolute increase of 12.2% (from 7.1% to 19.3%).
Over half of patients achieved HbF levels ≥20%, a threshold linked to meaningful clinical protection.
Marked improvements were observed in hemolysis markers, anemia, and reduction in vaso-occlusive crises (VOCs), with 7 of 12 patients reporting no VOCs during treatment.
Pociredir was generally well-tolerated at 20 mg, with no treatment-related serious adverse events or discontinuations.
Ended 2025 with $352.3 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2029.
Financial highlights
Cash, cash equivalents, and marketable securities increased to $352.3 million as of December 31, 2025, up from $241.0 million at year-end 2024.
Completed a $164.2 million public offering in December 2025 to support ongoing development.
Research and development expenses for 2025 were $56.1 million, down from $63.4 million in 2024, mainly due to program discontinuations and cost sharing.
General and administrative expenses for 2025 were $28.7 million, down from $36.4 million in 2024.
Net loss for 2025 was $74.9 million, compared to $9.7 million in 2024.
Outlook and guidance
Plans to update on next trial design in Q2, pending FDA feedback, with a potential registration-enabling trial to start in the second half of 2026.
Engagement with the European Medicines Agency is planned for mid-2026.
Cash runway is expected to fund operations into 2029 based on current plans.
An open-label extension study is being activated to assess long-term safety and durability.
Pociredir's differentiation for SCD treatment
Impact of pipeline focus on benign hematology
Future R&D spend given pipeline focus?
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Next Fulcrum Therapeutics earnings date
Leerink Global Healthcare Conference 202610 Mar, 2026
Fulcrum Therapeutics
Next Fulcrum Therapeutics earnings date
Leerink Global Healthcare Conference 202610 Mar, 2026
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Frequently asked questions
Fulcrum Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing therapies to treat genetically defined rare diseases. The company leverages its proprietary product engine to identify and target genetic mechanisms underlying diseases. Fulcrum’s primary areas of focus include muscle and central nervous system disorders, with therapeutic candidates aimed at modulating gene expression to address the root causes of these conditions. The company is advancing its treatments through clinical trials, working to provide new options for patients with limited or no available therapies. The company is headquartered in Cambridge, Massachusetts, and its shares are listed on the NASDAQ.
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