Core Viewpoint - Larimar Therapeutics is advancing its clinical development program for nomlabofusp, aiming for a Biologics License Application (BLA) submission by the end of 2025, with a focus on potential accelerated approval for treating Friedreich's ataxia (FA) [2][4][12] Company Updates - The company reported a net loss of $29.3 million for Q1 2025, compared to a net loss of $14.7 million in Q1 2024, reflecting increased research and development expenses [6][18] - As of March 31, 2025, Larimar had a strong balance sheet with $157.5 million in cash, cash equivalents, and marketable securities, providing a cash runway into Q2 2026 [4][6] - The FDA has indicated openness to considering skin FXN concentration as a surrogate endpoint for accelerated approval, which could support the BLA submission [4][5] Clinical Development - Larimar plans to initiate a global Phase 3 study in mid-2025, following regulatory feedback on the study protocol [2][12] - The company has completed dosing in an adolescent pharmacokinetic (PK) run-in study and expects to present data from this cohort in September 2025 [5][12] - The ongoing open-label extension (OLE) study is expected to provide topline data on the 50 mg dose in September 2025 [5][12] Financial Performance - Research and development expenses for Q1 2025 were $26.6 million, significantly higher than $12.9 million in Q1 2024, driven by increased manufacturing and clinical costs [7][18] - General and administrative expenses rose to $4.6 million in Q1 2025 from $3.8 million in Q1 2024, primarily due to higher personnel and consulting fees [8][18]

As filed with the Securities and Exchange Commission on July 3, 2024. Registration No. 333-279121 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SERINA THERAPEUTICS, INC. (Exact Name of Registrant as Specified in our Charter) Delaware 2834 82-1436829 (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification ...