Larimar Therapeutics Reports Third Quarter 2025 Financial Results

Core Insights - Larimar Therapeutics reported positive long-term data from its open label study of nomlabofusp, indicating potential to alter the disease course of Friedreich's ataxia (FA) [2][3][4] - The company plans to submit a Biologics License Application (BLA) seeking accelerated approval in the second quarter of 2026 [2][4][10] Clinical Development - In the open label study, 100% of participants achieved skin frataxin (FXN) levels over 50% of median levels in healthy volunteers after 6 months [3][4] - A median improvement of 2.25 in the modified Friedreich Ataxia Rating Scale (mFARS) score was observed after 1 year, compared to a worsening of 1.00 in the FACOMS reference population [3][4] - The company is implementing a modified starting dose regimen to mitigate the risk of anaphylactic reactions, which will also be incorporated into the Phase 3 protocol [4][10] Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $175.4 million, with a projected cash runway into the fourth quarter of 2026 [5][10] - The net loss for the third quarter of 2025 was $47.7 million, or $0.61 per share, compared to a net loss of $15.5 million, or $0.24 per share, for the same period in 2024 [6][19] - Research and development expenses for the third quarter of 2025 were $44.9 million, significantly higher than $13.9 million for the same period in 2024, primarily due to increased manufacturing costs for nomlabofusp [7][11] Future Plans - Larimar plans to provide an update on the nomlabofusp development program, including regulatory discussions and the open label study status, in the first quarter of 2026 [10][11] - The company is focused on advancing its global Phase 3 study and preparing for patient enrollment [10][11]