Analyst Summary:
Fulcrum Therapeutics, a clinical-stage biopharmaceutical company reported Q4 and full-year financial results and provided an update on its business, including FTX-6058 for SCD treatment. The company announced that the FDA placed the investigational new drug application (IND) for FTX-6058 for SCD treatment on full clinical hold citing similar hematological malignancies observed in the non-clinical studies of FTX-6058 with other inhibitions of PRC2. The company remains on track to complete enrollment in the losmapimod Phase 3 REACH trial in the second half of 2023. Fulcrum expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements into mid-2025. The company will host a conference call and webcast on March 10, 2023.
Quotes from CEO or Management:
"We are confident that FTX-6058 has the potential to provide a differentiated therapeutic option for people living with sickle cell disease and that the clinical and preclinical data generated to date demonstrate a favorable benefit-risk profile," said Robert J. Gould, Ph.D., interim president, and chief executive officer.
Summary of forward-looking statements:
Fulcrum Therapeutics provided forward-looking statements related to the completion of the REACH trial and sufficient funds to fulfill future commitments. However, the company specifically disclaims any obligation to update these forward-looking statements.