
Financial Performance - The company reported a net loss of 0.46 per share, for Q1 2025, compared to a net loss of 0.27 per share, for Q1 2024, indicating a 99% increase in net loss year-over-year[8] - Total operating expenses rose to 16,734,000 in Q1 2024, marking an increase of 86%[20] - Net loss for Q1 2025 was 14,654,000 in Q1 2024, reflecting a 99% increase in losses[20] - Net loss per share, basic and diluted, was 0.27 in Q1 2024, indicating a 70% increase in loss per share[20] - Total comprehensive loss for Q1 2025 was 14,760,000 in Q1 2024, representing a 99% increase[20] - Other income, net, decreased to 2,080,000 in Q1 2024, a decline of 8%[20] - Unrealized loss on marketable securities was 106,000 in Q1 2024[20] Expenses - Research and development expenses for Q1 2025 were 12.9 million in Q1 2024, primarily due to a 4.6 million in Q1 2025 from 0.7 million rise in personnel expenses[10] - Research and development expenses increased to 12,939,000 in Q1 2024, representing a 105% increase[20] Cash Position - As of March 31, 2025, Larimar Therapeutics reported cash, cash equivalents, and marketable securities totaling 25.9 million, a decrease from $28.4 million as of December 31, 2024[17] Development Plans - Larimar plans to submit a Biologics License Application (BLA) by the end of 2025, seeking accelerated approval for nomlabofusp, with a global Phase 3 study expected to initiate in mid-2025[3][5] - The FDA has indicated openness to considering skin FXN concentration as a surrogate endpoint for accelerated approval, which could support the BLA submission[5][6] - Data from the ongoing open-label extension study, including results from the 50 mg dose cohort, is expected to be reported in September 2025[12] - The company completed dosing in the adolescent pharmacokinetic run-in study, with data from this cohort anticipated in the upcoming program update[6][12] - Larimar plans to transition to a lyophilized formulation of nomlabofusp in mid-2025, which is intended for commercialization[12] Shareholder Information - Weighted average common shares outstanding increased to 63,964,008 in Q1 2025 from 53,553,707 in Q1 2024, a rise of 19%[20]