Larimar Therapeutics(LRMR) - 2024 Q3 - Quarterly Results

Financial Performance - The net loss for the third quarter of 2024 was $15.5 million, or $0.24 per share, compared to a net loss of $9.1 million, or $0.21 per share, for the same period in 2023[6]. - For the nine-month period ending September 30, 2024, the net loss was $51.8 million, or $0.86 per share, compared to a net loss of $24.0 million, or $0.55 per share, for the same period in 2023[9]. - Net loss for Q3 2024 was $15,499,000, up from a net loss of $9,064,000 in Q3 2023, representing a 70.5% increase[19]. - Net loss per share for Q3 2024 was $0.24, compared to $0.21 in Q3 2023[19]. - Total comprehensive loss for Q3 2024 was $14,991,000, compared to $9,069,000 in Q3 2023, indicating a 65.5% increase[19]. Expenses - Research and development expenses for the third quarter of 2024 were $13.9 million, up from $6.6 million in the third quarter of 2023, primarily due to a $3.8 million increase in nomlabofusp manufacturing costs[7]. - General and administrative expenses increased to $4.3 million in the third quarter of 2024 from $3.8 million in the third quarter of 2023, driven by higher personnel and consulting costs[8]. - Research and development expenses for the nine-month period ending September 30, 2024, were $46.5 million, compared to $17.0 million for the same period in 2023, with a significant increase in nomlabofusp manufacturing costs[10]. - Total operating expenses for Q3 2024 were $18,264,000, a 76.8% increase from $10,339,000 in Q3 2023[19]. - Research and development expenses reached $13,919,000 in Q3 2024, compared to $6,585,000 in Q3 2023, marking a 111.5% increase[19]. Cash Position - As of September 30, 2024, Larimar Therapeutics reported cash, cash equivalents, and marketable securities totaling $203.7 million, providing a projected cash runway into 2026[5]. Development Plans - Larimar plans to provide a nomlabofusp development program update in mid-December 2024, including safety, pharmacokinetic, and frataxin data from ongoing studies[3]. - A global confirmatory/registration study for nomlabofusp is planned to initiate in mid-2025, with a Biologics License Application submission targeted for the second half of 2025[4]. - Larimar is on track to initiate a pharmacokinetic run-in study in adolescents by year-end 2024, with plans for a second cohort of younger children to follow next year[3]. Regulatory Designation - The company received Innovative Licensing and Access Pathway designation from the MHRA, aimed at facilitating patient access to nomlabofusp in the U.K.[3]. Shareholder Information - Weighted average common shares outstanding increased to 63,806,158 in Q3 2024 from 43,903,738 in Q3 2023[19]. - Total liabilities and stockholders' equity amounted to $219,021,000, compared to $95,935,000 previously reported[18].