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Mar 31, 2022
Fulcrum Therapeutics Q1 2022 Earnings Report
Fulcrum Therapeutics reported first quarter 2022 financial results and business highlights.
Key Takeaways
Fulcrum Therapeutics reported a net loss of $25.9 million for the first quarter of 2022. The company's clinical programs continued to progress, with upcoming milestones including data presentations for FTX-6058 and the initiation of the Phase 3 REACH trial for losmapimod.
Initial data from Phase 1b trial of FTX-6058 in sickle cell disease to be presented at the EHA 2022 Congress.
Phase 3 REACH trial of losmapimod in FSHD expected to begin in 2Q 2022.
Cash, cash equivalents, and marketable securities were $195.1 million as of March 31, 2022.
Collaboration revenue was $2.6 million for the first quarter of 2022.
Fulcrum Therapeutics
Fulcrum Therapeutics
Forward Guidance
Fulcrum Therapeutics anticipates several milestones, including presenting data from the FTX-6058 trial, initiating the REACH trial, and nominating a new development candidate.
Positive Outlook
- Report initial data from the ongoing 6 mg dose cohort in the Phase 1b trial in people with sickle cell disease at the European Hematology Association (EHA) 2022 Hybrid Congress, taking place from June 9-12, 2022.
- Open next dose cohort in Phase 1b trial in people with sickle cell disease in the second quarter of 2022.
- Initiate registrational trial in sickle cell disease in early 2023.
- Initiation of Phase 1b trial in select other hemoglobinopathies, including beta-thalassemia, now expected in the second half of 2022.
- Initiate REACH, a Phase 3 randomized, double-blind, placebo-controlled multi-national trial that will evaluate the efficacy and safety of losmapimod for Facioscapulohumeral Muscular Dystrophy (FSHD), in the second quarter of 2022.
Challenges Ahead
- Risks associated with Fulcrum’s ability to continue to advance its product candidates in clinical trials.
- Risks related to initiating and enrolling clinical trials on the timeline expected or at all.
- Risks related to obtaining and maintaining necessary approvals from the FDA and other regulatory authorities.
- Risks related to replicating in clinical trials positive results found in preclinical studies and/or earlier-stage clinical trials of losmapimod, FTX-6058 and its other product candidates.
- Risks related to managing expenses and raising the substantial additional capital needed to achieve its business objectives.