Fulcrum Therapeutics Inc (FULC) Reports Q3 2023 Financial Results and Business Highlights

In this article:
  • Fulcrum Therapeutics Inc (NASDAQ:FULC) reported a net loss of $24.0 million for Q3 2023, compared to $23.7 million for Q3 2022.

  • The company's cash position as of September 30, 2023, was $257.1 million, compared to $202.9 million as of December 31, 2022.

  • FULC completed enrollment in the Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD), with topline data expected in Q4 2024.

  • The FDA lifted the clinical hold for pociredir (formerly FTX-6058) in sickle cell disease (SCD), with trial reinitiation underway.

On November 7, 2023, Fulcrum Therapeutics Inc (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules for patients with genetically defined rare diseases, announced its financial results for the third quarter of 2023.

Business Highlights

FULC completed enrollment in the Phase 3 REACH trial of losmapimod for FSHD, with topline data expected in Q4 2024. The company also reported that the FDA lifted the clinical hold for pociredir in SCD, with trial reinitiation underway. "We remain focused on strong execution and believe we are now well-positioned to deliver on important clinical milestones," said Alex C. Sapir, Fulcrums president and chief executive officer.

Financial Results

As of September 30, 2023, FULC's cash, cash equivalents, and marketable securities were $257.1 million, compared to $202.9 million as of December 31, 2022. Collaboration revenue for Q3 2023 was $0.8 million, compared to $1.2 million for Q3 2022. Research and development expenses were $18.2 million for Q3 2023, compared to $15.4 million for Q3 2022. General and administrative expenses were $10.0 million for Q3 2023, compared to $9.7 million for Q3 2022. The company reported a net loss of $24.0 million for Q3 2023, compared to $23.7 million for Q3 2022.

Updated Cash Runway Guidance

FULC updated its cash runway guidance, now expecting that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its operating requirements into 2026, an update to previous guidance of mid-2025.

About Fulcrum Therapeutics

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrums two lead programs in clinical development are losmapimod, a small molecule in development for the treatment of facioscapulohumeral muscular dystrophy (FSHD), and pociredir (formerly known as FTX-6058), a small molecule designed to increase expression of fetal hemoglobin and in development for the treatment of sickle cell disease (SCD) and other hemoglobinopathies.

Explore the complete 8-K earnings release (here) from Fulcrum Therapeutics Inc for further details.

This article first appeared on GuruFocus.

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