Larimar Therapeutics(LRMR) - 2025 Q3 - Quarterly Results

Financial Performance - 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[7]. - The net loss for the first nine months of 2025 was $103.2 million, or $1.50 per share, compared to a net loss of $51.8 million, or $0.86 per share, for the same period in 2024[10]. - The net loss for the three months ended September 30, 2025, was $47,712 thousand, compared to a net loss of $15,499 thousand for the same period in 2024, indicating a year-over-year increase in losses of approximately 208%[20]. - The net loss per share, basic and diluted, for the three months ended September 30, 2025, was $0.61, compared to $0.24 for the same period in 2024, representing an increase of approximately 154%[20]. - The total comprehensive loss for the three months ended September 30, 2025, was $47,637 thousand, compared to $14,991 thousand for the same period in 2024, indicating an increase of approximately 217%[20]. Research and Development - Research and development expenses for the third quarter of 2025 were $44.9 million, up from $13.9 million in the third quarter of 2024, primarily due to a $25.8 million increase in nomlabofusp manufacturing costs[8]. - Research and development expenses for the three months ended September 30, 2025, were $44,931 thousand, significantly up from $13,919 thousand in the same period of 2024, representing an increase of about 222%[20]. - 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 a FACOMS reference population[5]. - In the open label study, 100% of participants (n=10) achieved skin FXN levels similar to asymptomatic carriers after 6 months of daily nomlabofusp administration[5]. - Seven out of 39 participants in the open label study experienced anaphylaxis in the first 6 weeks of dosing, but returned to their usual state of health after standard treatment[4]. - The company is implementing a modified starting dose regimen to mitigate the risk of anaphylactic reactions, which includes a 5 mg test dose followed by a 25 mg dose[5]. - The company plans to submit a Biologics License Application (BLA) seeking accelerated approval for nomlabofusp in the second quarter of 2026[4]. Assets and Liabilities - As of September 30, 2025, Larimar Therapeutics had cash, cash equivalents, and marketable securities totaling $175.4 million, with a projected cash runway into the fourth quarter of 2026[6]. - Total current assets decreased from $195,304 thousand as of December 31, 2024, to $183,223 thousand as of September 30, 2025, a decline of approximately 6%[18]. - Total liabilities increased from $28,413 thousand as of December 31, 2024, to $48,312 thousand as of September 30, 2025, reflecting a rise of about 70%[18]. - The total stockholders' equity decreased from $171,812 thousand as of December 31, 2024, to $139,038 thousand as of September 30, 2025, a decline of about 19%[18]. Operating Expenses - General and administrative expenses for the third quarter of 2025 were $4.6 million, compared to $4.3 million in the third quarter of 2024[9]. - Total operating expenses for the nine months ended September 30, 2025, were $108,479 thousand, compared to $59,597 thousand for the same period in 2024, an increase of about 82%[20]. - Other comprehensive loss for the three months ended September 30, 2025, included an unrealized gain on marketable securities of $75 thousand, compared to a gain of $508 thousand in the same period of 2024[20]. Shareholder Information - The weighted average common shares outstanding for the three months ended September 30, 2025, were 78,324,767, up from 63,806,158 in the same period of 2024, an increase of approximately 22%[20].