Successful Enrollment in Phase 1b PIONEER Trial
Fulcrum Therapeutics completed enrollment of the 12 milligram cohort in their Phase 1b PIONEER trial for sickle cell disease, with 16 patients enrolled. The trial is progressing to the 20 milligram cohort.
Positive Data Monitoring Committee Recommendation
The Data Monitoring committee recommended continuing the PIONEER study as planned after reviewing interim data from the 12 milligram cohort, allowing the initiation of the 20 milligram cohort.
Financial Improvements and Cost Reductions
Research and development expenses decreased by $6.4 million compared to the first quarter of 2024, attributed to the discontinuation of the losmapimod program and cost-sharing with Sanofi. General and administrative expenses also decreased by $3.1 million.
Strong Financial Position
Fulcrum ended the first quarter of 2025 with $226.6 million in cash, cash equivalents, and marketable securities, sufficient to fund operations into at least 2027.
Upcoming Data Releases
Fulcrum plans to release data from the 12 milligram cohort in early Q3 and the 20 milligram cohort by the end of 2025, with additional presentations at the European Hematology Association meeting.