BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) reported fourth-quarter and full-year 2025 financial results while advancing its lead candidate nomlabofusp toward a planned FDA filing for the treatment of Friedreich’s ataxia, the company announced.
The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to nomlabofusp for adults and children with the condition, based on clinical data from an ongoing open-label study.
The company said it remains aligned with the FDA on plans to submit a Biologics License Application seeking accelerated approval in June 2026. Topline data from the open-label study is expected in the second quarter of 2026.
Larimar also plans to begin screening for a global Phase 3 confirmatory study in the second quarter of 2026, with initial patient dosing expected mid-year.
If approved, the company said a U.S. launch is targeted for the first half of 2027.
The FDA indicated it is willing to consider frataxin (FXN) as a surrogate endpoint for the planned application and confirmed that the proposed use of matched patient data from the Friedreich’s Ataxia Clinical Outcomes Measure Study database is appropriate for comparison of clinical outcomes.
The agency also agreed that a change in Upright Stability Score would be a reasonable primary endpoint for the Phase 3 study, while noting that the adequacy of the safety dataset will be determined during review.
Larimar reported cash, cash equivalents, and marketable securities of $136.9 million as of December 31, 2025. Including approximately $107.6 million in net proceeds from a February 2026 public offering, the company said it expects its cash runway to extend into the second quarter of 2027.
For the fourth quarter of 2025, the company reported a net loss of $62.5 million, or $0.73 per share, compared to a net loss of $28.8 million, or $0.45 per share, in the same period a year earlier.
Research and development expenses for the quarter increased to $59.4 million from $26.7 million, driven primarily by manufacturing costs related to nomlabofusp and expanded clinical and regulatory activities.
General and administrative expenses were $4.6 million, unchanged from the prior year period.
For the full year 2025, Larimar reported a net loss of $165.7 million, or $2.27 per share, compared to $80.6 million, or $1.32 per share, in 2024.
Research and development expenses for the year rose to $154.2 million from $73.3 million, reflecting increased manufacturing, clinical, and personnel costs tied to nomlabofusp development.
General and administrative expenses increased to $18.3 million from $17.6 million, primarily due to higher personnel and consulting costs.
Other income totaled $6.8 million for the year, compared to $10.3 million in 2024, reflecting lower interest income and reduced average investment balances.
The company said its recent financing and regulatory progress position it to advance nomlabofusp through planned clinical and regulatory milestones.
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