BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) announced its second-quarter 2024 financial results and significant progress in its nomlabofusp development program.
Key Achievements:
- The FDA selected Larimar’s nomlabofusp program for the START pilot program to help with its timeline for a BLA submission targeting the second half of 2025.
- The company is preparing to initiate a global confirmatory study in mid-2025 with clinical sites in the U.S., Europe, U.K., Canada, and Australia.
- Larimar joined the TRACK-FA Neuroimaging Consortium to support research on neuroimaging biomarkers for use in clinical trials.
- All seven sites for the OLE study are now activated, with interim data expected in Q4 2024.
- A PK run-in study in adolescents with Friedreich’s ataxia (FA) is planned to start by year-end.
“We made significant achievements in our nomlabofusp program this quarter that strongly position us for successful execution across important catalysts over the next 12 months,” said Carole Ben-Maimon, MD, President, and CEO of Larimar. “We are excited to have recently joined the TRACK-FA Neuroimaging Consortium as an industry partner to support research to define disease-specific neuroimaging biomarkers for potential use in clinical trials.”
Financial Highlights:
- Cash Position: As of June 30, 2024, Larimar had cash, cash equivalents, and marketable securities totaling $226.1 million, providing a cash runway into 2026.
- Net Loss: $21.6 million for Q2 2024, compared to $8.4 million in Q2 2023.
- R&D Expenses: $19.7 million, up from $5.9 million, driven by increased manufacturing and clinical trial costs.
- G&A Expenses: $4.9 million, up from $3.7 million, due to higher legal, professional, and personnel costs.
Buy, Sell, or Hold?
Larimar Therapeutics shows promise with its advancements in the nomlabofusp program and a solid financial position. However, the increased expenses and ongoing need for successful clinical trials add risk. Given these factors, Larimar Therapeutics is a Hold. Investors should watch for clinical trial results and regulatory progress.
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