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Jun 30, 2022
Fulcrum Therapeutics Q2 2022 Earnings Report
Announced second quarter 2022 financial results and provided a business update.
Key Takeaways
Fulcrum Therapeutics reported financial results for Q2 2022, highlighted by key milestones in their clinical programs including compelling proof of concept data for 6058 and the initiation of the first registrational trial for FSHD, while also announcing a strategic plan to realign internal resources to support clinical programs and extend cash runway.
Presented initial data from Phase 1b trial in sickle cell disease (SCD), demonstrating rapid and robust increases in hemoglobin F (HbF).
Announced enrollment of first patient in Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD).
Announced strategic realignment to reduce operating expenses by $40-50M, prioritize clinical execution, and extend cash runway into mid-2024.
Mel Hayes was promoted to the role of Chief Operating Officer and Curt Oltmans was promoted to the role of Chief Legal Officer.
Fulcrum Therapeutics
Fulcrum Therapeutics
Forward Guidance
Fulcrum expects that its existing cash, cash equivalents, and marketable securities will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into mid-2024.
Positive Outlook
- Completing enrollment in the Phase 1b SCD trial of FTX-6058.
- Initiating a registrational trial of FTX-6058 in SCD.
- Advancing the REACH trial.
- Submitting the next IND.
- Realignment of internal investments and operations to prioritize clinical programs.
Challenges Ahead
- Delaying initiation of Phase 1b trial in non-SCD hemoglobinopathies, including beta-thalassemia.
- Strategic realignment will result in a workforce reduction of 25% of planned headcount.
- The company anticipates that subsequent events and developments will cause Fulcrum’s views to change.
- The company's views as of the date of the press release should not be relied upon as representing Fulcrum’s views as of any date subsequent to the date hereof.
- Fulcrum specifically disclaims any obligation to update forward-looking statements.