Fulcrum Therapeutics reported a collaboration revenue of $0.7 million and a net loss of $26.1 million for the fourth quarter of 2022. The company is working to address the clinical hold on FTX-6058 and remains on track to complete enrollment in the losmapimod Phase 3 REACH trial during 2H’23.
The FDA placed a full clinical hold on the IND application for FTX-6058 due to preclinical and clinical evidence of hematological malignancies observed with other PRC2 inhibitors.
Fulcrum is working to address the clinical hold on FTX-6058 and believes it has the potential to be a differentiated therapeutic option for sickle cell disease.
The company is on track to complete enrollment in the Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy during the second half of 2023.
Fulcrum completed a public offering in 1Q'23, generating approximately $117.3 million in net proceeds, and expects its cash runway to extend into mid-2025.
Fulcrum expects that its existing cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into mid-2025.