Larimar reports FDA open to FXN as surrogate endpoint; BLA submission on track for end-2025

Larimar Therapeutics, Inc.

FDA considers skin FXN concentration reasonably likely surrogate endpoint for accelerated approval of nomlabofusp in Friedreich's ataxia.
BLA submission for accelerated approval targeted by year-end 2025; global Phase 3 study to initiate mid-2025.
Net loss of $28.8M in Q4 2024 ($0.45/share) vs. $13.0M ($0.30/share) in Q4 2023; R&D expenses rose to $26.7M.
Cash and equivalents $183.5M as of Dec 31, 2024; projected runway into Q2 2026.
OLE study amended to include premedication after anaphylaxis deemed adverse drug reaction; 50 mg data expected Sept 2025.

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