Larimar Therapeutics Q2 2024 Operating and Financial Results

Larimar Therapeutics, Inc., a clinical-stage biotechnology company, recently shared its accomplishments and financial performance for the second quarter of 2024. Based in Bala Cynwyd, Pennsylvania, Larimar is advancing treatments for complex rare diseases, with a primary focus on its lead compound, nomlabofusp, intended to treat Friedreich's ataxia (FA).

In a notable achievement, the U.S. Food and Drug Administration (FDA) selected Larimar to participate in the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. This program could facilitate the accelerated approval process for nomlabofusp, with a target for Biologics License Application (BLA) submission set for the latter half of 2025. To support this, Larimar is preparing to launch a global confirmatory study by mid-2025, targeting potential sites across the U.S., Europe, U.K., Canada, and Australia.

The company has also joined the TRACK-FA Neuroimaging Consortium, a collaborative effort with pharmaceutical, biotechnology, academic, and clinical partners focused on developing neuroimaging biomarkers specific to FA. This consortium aims to establish a natural history study to track disease progression, which will be critical for future clinical trials.

The Open Label Extension (OLE) study for nomlabofusp is moving ahead, with all seven clinical sites now active. Larimar plans to report interim data in the fourth quarter of 2024. Additionally, the company is set to initiate a pharmacokinetic (PK) run-in study in adolescents aged 12 to 17 by the end of the year. This study will include 12-15 participants who will be randomized to receive either nomlabofusp or a placebo, and successful participants will be transitioned into the ongoing OLE study.

Financially, Larimar is on solid ground, ending the second quarter of 2024 with $226.1 million in cash, cash equivalents, and marketable securities. This robust financial standing is projected to fund the company’s operations through 2026. However, the company reported a net loss of $21.6 million for the second quarter of 2024, a significant increase from the $8.4 million loss in the same period the previous year. This uptick is attributed to increased research and development expenses, which rose to $19.7 million from $5.9 million, driven by higher manufacturing costs for nomlabofusp and increased clinical trial costs. General and administrative expenses also saw a rise to $4.9 million from $3.7 million, mainly due to higher legal and professional fees, and additional personnel costs.

For the first half of 2024, Larimar reported a net loss of $36.3 million, up from $14.9 million in the same period in 2023. Research and development expenses for this period totaled $32.6 million, reflecting a substantial increase from $10.4 million in the previous year. This rise is mainly due to higher costs associated with nomlabofusp manufacturing and clinical trials, particularly the OLE study and the TRACK-FA natural history study. General and administrative expenses for the first half of the year were $8.7 million, compared to $6.8 million in the same period last year.

Larimar Therapeutics continues to advance its mission of developing treatments for rare diseases, leveraging both its financial resources and strategic partnerships to propel its clinical programs forward. The planned studies and collaborations, along with the FDA's support through the START program, position Larimar well for future milestones, including the potential accelerated approval of nomlabofusp.