Larimar Therapeutics reported a net loss of $47.7 million, or $0.61 per share, for the third quarter of 2025, a widening from the $15.5 million loss ($0.24 per share) reported for the same period in 2024 and from the $26.2 million loss ($0.41 per share) in Q2 2025. The loss exceeded analysts’ consensus estimate of a $0.39 per share loss, a miss of $0.22 per share, reflecting the company’s continued investment in its lead product and the higher cost base of the quarter.
The company’s research and development expense surged to $44.9 million, up from $13.9 million in Q3 2024 and $23.4 million in Q2 2025. The jump is largely driven by a $25.8 million increase in manufacturing costs for nomlabofusp, the company’s frataxin replacement therapy, and additional clinical and regulatory expenditures required to support the drug’s accelerated‑approval pathway.
Cash, cash equivalents and marketable securities stood at $175.4 million as of September 30 2025, including $65 million in net proceeds from a July 2025 public offering. The balance provides a runway that extends into the fourth quarter of 2026, giving the company time to complete its clinical program and prepare for a Biologics License Application (BLA) submission in Q2 2026.
Clinical data from the open‑label study remain encouraging. Fourteen participants have received at least six months of treatment and eight have exceeded one year, with consistent directional improvements across key outcomes: the modified Friedreich’s Ataxia Rating Scale (mFARS), the Friedreich’s Ataxia Rating Scale‑Activities of Daily Living (FARS‑ADL), the nine‑hole peg test (9‑HPT) and the Modified Fatigue Impact Scale (MFIS). In a subset of ten participants, 100 % achieved skin frataxin concentrations above 50 % of the healthy median at six months, and the median mFARS improvement at one year was 2.25 points, underscoring the drug’s potential to modify disease progression.
Management reiterated its focus on advancing nomlabofusp toward regulatory approval. CEO Carole Ben‑Maimon said the company is “focused on execution of our near‑term milestones that will advance nomlabofusp as the first potential disease‑modifying therapy designed to address the root cause of Friedreich’s ataxia.” She added that the company will submit a BLA in Q2 2026 and that a revised, modified starting‑dose regimen has been adopted to mitigate anaphylaxis risk, a safety concern that has been addressed in the updated Phase 3 protocol.
The earnings miss reflects the company’s heavy investment in R&D and the higher manufacturing cost of nomlabofusp, but the positive clinical data and strong cash position provide a foundation for continued progress toward accelerated approval. While the quarter’s loss was larger than expected, the company’s trajectory remains aligned with its long‑term goal of delivering a first‑in‑class therapy for a rare, unmet‑need disease.
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