Larimar Therapeutics, Inc. (Larimar) (NASDAQ: LRMR) recently announced its third-quarter 2024 operating and financial results, showcasing its progress in developing treatments for complex rare diseases, particularly Friedreich's ataxia (FA).
Financially, as of September 30, 2024, Larimar reported having $203.7 million in cash, cash equivalents, and marketable securities, projecting a cash runway into 2026. However, the company reported a net loss of $15.5 million, or $0.24 per share, for the third quarter of 2024, compared to a net loss of $9.1 million, or $0.21 per share, for the third quarter of 2023. This increase in net loss was primarily driven by higher research and development expenses.
Speaking of research and development expenses, for the third quarter of 2024, they were $13.9 million, compared to $6.6 million for the third quarter of 2023. This significant increase was mainly due to higher manufacturing costs for Nomlabofusp, increased personnel expenses, assay development costs, clinical costs, professional fees, stock compensation costs, and internal lab costs.
Looking at the nine months ended September 30, 2024, Larimar reported a net loss of $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. Research and development expenses for the nine months ending September 30, 2024, were $46.5 million, compared to $17.0 million for the same period in 2023. Similar to the quarterly results, the increase was primarily driven by higher manufacturing costs, personnel expenses, clinical costs, assay development costs, and professional fees.
On the operational front, Larimar is making significant strides in advancing its Nomlabofusp program. It is on track to provide a program update in mid-December, including safety, pharmacokinetic (PK), and frataxin data, as well as clinical outcomes observations from patients receiving a daily 25 mg dose of Nomlabofusp for 30 to 180 days in an ongoing open-label extension (OLE) study. Additionally, it plans to initiate a PK run-in study in adolescents by the year-end, with a global confirmatory/registration study planned for mid-2025.
Moreover, the company has received innovative licensing and access pathway (ILAP) designation in the U.K., orphan drug designations in the U.S. and the European Union (EU), fast track and rare pediatric disease designations in the U.S., Prime designation in the EU, and has been selected to be in the START pilot program by the FDA, demonstrating significant progress on the regulatory front.
Larimar's upcoming presentations at the International Congress for Ataxia Research (ICAR) meeting in November 2024 will provide further insight into the company's developments, including data from its completed dose exploration study and patient data from its phase 1 and phase 2 studies.
Following these announcements, the company's shares moved 8.2%, and are now trading at a price of $8.42. If you want to know more, read the company's complete 8-K report here.
