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Fulcrum Therapeutics (FULC) investor relations material

Fulcrum Therapeutics Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary29 Oct, 2025

Executive summary

  • Lead program pociredir advanced in Phase 1b for sickle cell disease, showing dose-dependent increases in fetal hemoglobin, improved clinical biomarkers, and strong tolerability, with positive results from the 12 mg cohort and enrollment completed for the 20 mg cohort; data expected by year-end 2025.

  • Open-label extension trial for pociredir initiated to provide longer-term safety and durability data, responding to patient and investigator demand.

  • Pipeline progress includes IND planned for bone marrow failure syndromes in Q4 2025 and preclinical efficacy for FTX-6274 in prostate cancer models.

  • Discontinued losmapimod program and terminated Sanofi collaboration after Phase 3 failure, with pipeline now centered on pociredir and early-stage discovery programs.

  • Workforce reduced from 80 to 51 employees as part of R&D reprioritization.

Financial highlights

  • Q3 2025 net loss was $19.6M, compared to $21.7M in Q3 2024; net loss per share was $0.31 for Q3 2025.

  • R&D expenses were $14.3M for Q3 2025, down from $14.6M in Q3 2024, mainly due to workforce reduction and discontinued programs.

  • General administrative expenses were $7.6M for Q3 2025, down from $8.4M in Q3 2024.

  • Cash, cash equivalents, and marketable securities totaled $200.6M at quarter-end, down from $241M at year-end 2024.

  • Working capital as of September 30, 2025, was $194.2M, and total assets were $214.9M.

Outlook and guidance

  • Cash reserves are expected to fund operations and capital expenditures into 2028, supporting clinical and preclinical programs.

  • Full PIONEER data set from the 20 mg cohort expected by end of 2025, with an end-of-Phase I FDA meeting planned.

  • IND submission for bone marrow failure syndromes planned for Q4 2025.

  • Anticipates increased expenses as pociredir advances and new programs enter clinical development.

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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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