BALA CYNWYD, Pa. — August 14, 2025 — Leads & Copy — Larimar Therapeutics Inc. (Nasdaq: LRMR) reported its second quarter 2025 operating and financial results, highlighting the advancement of its nomlabofusp program. The company anticipates initial data from the 50 mg dose in the open label study and the adolescent PK run-in study in September 2025.
Adolescent participants and patients with Friedreich’s ataxia (FA) are being screened and enrolled in the open label study, with plans to enroll children aged 2 to 11 directly. The FDA has recommended a safety database including at least 30 participants with continuous study drug exposure for six months, and a subset of at least 10 participants for one year, primarily receiving 50 mg nomlabofusp.
Larimar has published two peer-reviewed articles, with nonclinical data supporting the mechanism of action of nomlabofusp and the potential use of skin FXN concentrations as a surrogate endpoint. The company remains on track to submit a BLA seeking accelerated approval in the second quarter of 2026.
Global Phase 3 study activities are ongoing, with patient recruitment expected to begin later this year. As of June 30, 2025, Larimar had $203.6 million in pro forma cash, cash equivalents, and marketable securities, projecting a cash runway into the fourth quarter of 2026.
Carole Ben-Maimon, MD, President and CEO of Larimar, noted the company’s progress and collaboration with the FDA regarding the BLA submission, including potential accelerated approval based on skin frataxin levels. Enrollment in the open label study is ongoing, and sites for the Phase 3 trial have been identified.
Larimar reported a net loss for the second quarter of 2025 of $26.2 million, or $0.41 per share, compared to a net loss of $21.6 million, or $0.34 per share, for the second quarter of 2024. Research and development expenses for the second quarter of 2025 were $23.4 million compared to $19.7 million for the second quarter of 2024.
Investor Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
(212) 915-2569
Company Contact:
Michael Celano
Chief Financial Officer
mcelano@larimartx.com
(484) 414-2715
Source: Larimar Therapeutics, Inc.
