Larimar Therapeutics Reports Second Quarter 2025 Financial Results

Core Insights - Larimar Therapeutics, Inc. reported its second quarter 2025 operating and financial results, highlighting progress in its nomlabofusp program aimed at treating Friedreich's ataxia [2][3] Financial Performance - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $203.6 million, which includes $138.5 million in cash and $65.1 million from a public offering [1][7] - The net loss for the second quarter of 2025 was $26.2 million, or $0.41 per share, compared to a net loss of $21.6 million, or $0.34 per share, for the same period in 2024 [8] - Research and development expenses for the second quarter of 2025 were $23.4 million, up from $19.7 million in the second quarter of 2024, primarily due to increased clinical trial activity [9] - General and administrative expenses decreased to $4.4 million in the second quarter of 2025 from $4.9 million in the same quarter of 2024 [10] Clinical Development - The company is advancing its nomlabofusp program towards potential registration, with ongoing enrollment in an open-label study and plans to submit a Biologics License Application (BLA) in the second quarter of 2026 [3][5] - Initial data from the 50 mg dose in the open-label study and adolescent pharmacokinetic (PK) run-in study are expected in September 2025 [6][5] - The FDA has recommended that the safety database for the BLA include at least 30 participants with continuous study drug exposure for 6 months, with a subset of at least 10 participants for 1 year [12] Strategic Initiatives - Larimar has identified global sites for its Phase 3 trial and expects to initiate patient recruitment later this year [5][12] - The company has published two peer-reviewed articles supporting the mechanism of action of nomlabofusp and the use of skin frataxin concentrations as a surrogate endpoint [12][5] - The balance sheet has been strengthened through a recent capital raise, extending the projected cash runway into the fourth quarter of 2026 [7][12]