Fulcrum Therapeutics, Inc. (FULC) a clinical-stage biopharmaceutical company on Tuesday reported financial results for the fourth quarter and full year 2025, posting a widened net loss. In addition, the firm announced positive 12-week results from the 20 mg dose cohort of the Phase 1b PIONEER trial of Pociredir in Sickle Cell Disease or SCD.
Following the mixed news, FULC is plunging 13.22% at $9.45.
For the fourth quarter, net loss expanded to $20.3 million from $16.6 million in the prior year.
For the full year 2025, net loss widened to $74.9 milllion from $9.7 million in the year-ago period.
As of December 31, 2025, cash, cash equivalents, and marketable securities were $352.3 million, as compared to $241.0 million in the prior year. The increase of $111.3 million is primarily due to net proceeds of $164.2 million from the December 2025 public offering of our common stock and pre-funded warrants.
Fulcrum now expects that its current cash, cash equivalents, and marketable securities will be sufficient to fund its operating requirements into 2029.
Separately, Fulcrum also announced positive 12-week results from its Phase 1b PIONEER trial of Pociredir 20 mg in Sickle Cell Disease.
According to the trial results, Pociredir demonstrated a clinically relevant response, in increasing Mean absolute fetal hemoglobin with progression toward pan-cellular HbF induction.
In the 20 mg cohort of the study, patients showed a strong and rapid increase in fetal hemoglobin (HbF). On average, HbF levels rose from 7.1% at the start of the study to 19.3% at Week 12 - an increase of 12.2%. Patients also showed improvements in markers of hemolysis and anemia, and encouraging trends in vaso-occlusive crisis (VOC) reduction.
SCD is a genetic disorder of the red blood cells caused by a mutation in the HBB gene.
Pociredir has been granted Fast Track and Orphan Drug Designation from the FDA for the treatment of SCD.
Fulcrum plans to provide additional details regarding the design of its next trial in the second quarter of 2026, following receipt of meeting minutes from its End-of-Phase meeting with the FDA.
Subject to FDA feedback, Fulcrum plans to initiate a potential registration-enabling trial in the second half of 2026.
FULC has traded between $2.32 and $15.74. The stock closed Monday's trade at $10.89, down 1%.
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