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Larimar Therapeutics(LRMR) - 2025 Q1 - Quarterly Results

Financial Performance - The company reported a net loss of 29.3million,or29.3 million, or 0.46 per share, for Q1 2025, compared to a net loss of 14.7million,or14.7 million, or 0.27 per share, for Q1 2024, indicating a 99% increase in net loss year-over-year[8] - Total operating expenses rose to 31,188,000inQ12025,upfrom31,188,000 in Q1 2025, up from 16,734,000 in Q1 2024, marking an increase of 86%[20] - Net loss for Q1 2025 was 29,281,000,comparedtoanetlossof29,281,000, compared to a net loss of 14,654,000 in Q1 2024, reflecting a 99% increase in losses[20] - Net loss per share, basic and diluted, was 0.46inQ12025,comparedto0.46 in Q1 2025, compared to 0.27 in Q1 2024, indicating a 70% increase in loss per share[20] - Total comprehensive loss for Q1 2025 was 29,375,000,comparedto29,375,000, compared to 14,760,000 in Q1 2024, representing a 99% increase[20] - Other income, net, decreased to 1,907,000inQ12025from1,907,000 in Q1 2025 from 2,080,000 in Q1 2024, a decline of 8%[20] - Unrealized loss on marketable securities was 94,000inQ12025,slightlyimprovedfromalossof94,000 in Q1 2025, slightly improved from a loss of 106,000 in Q1 2024[20] Expenses - Research and development expenses for Q1 2025 were 26.6million,upfrom26.6 million, up from 12.9 million in Q1 2024, primarily due to a 7.1millionincreaseinmanufacturingcostsfornomlabofusp[9]Generalandadministrativeexpensesincreasedto7.1 million increase in manufacturing costs for nomlabofusp[9] - General and administrative expenses increased to 4.6 million in Q1 2025 from 3.8millioninQ12024,drivenbya3.8 million in Q1 2024, driven by a 0.7 million rise in personnel expenses[10] - Research and development expenses increased to 26,552,000inQ12025from26,552,000 in Q1 2025 from 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 157.5million,withaprojectedcashrunwayintothesecondquarterof2026[5][8]TotalliabilitiesasofMarch31,2025,were157.5 million, with a projected cash runway into the second quarter of 2026[5][8] - Total liabilities as of March 31, 2025, were 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]