Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates

Core Insights - Autolus Therapeutics achieved significant milestones in 2024, including FDA approval and commercial launch of AUCATZYL, a CAR T therapy for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) [2][5] - The company is focused on expanding its commercial launch and advancing its clinical pipeline in 2025, with plans to enter new markets and invest in the obe-cel opportunity [2][4] Financial Performance - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $588.0 million, up from$239.6 million in 2023, primarily due to a strategic collaboration with BioNTech [8] - The net loss for the year ended December 31, 2024, was $220.7 million, compared to a loss of$208.4 million in 2023, with a basic and diluted net loss per share of $(0.86) [12][18] - Research and development expenses increased to$138.4 million from $130.5 million in 2023, while selling, general, and administrative expenses rose significantly to$101.1 million from $46.7 million [10][11] Product Development and Regulatory Updates - AUCATZYL was approved by the FDA on November 8, 2024, and is progressing well in the U.S. commercial launch with 33 authorized treatment centers as of March 19, 2025 [4][5] - The company expects marketing authorizations for obe-cel from the MHRA and EMA in the second half of 2025 [4][6] - Initial data from the Phase 1 trial in systemic lupus erythematosus (SLE) will be presented at an R&D event on April 23, 2025 [7][20] Clinical Trials and Pipeline - The pivotal Phase 1b/2 FELIX clinical trial of obe-cel demonstrated high rates of durable responses with low incidence of severe immune-related toxicity [5][9] - Autolus is also advancing early-stage pipeline programs, including AUTO8 and AUTO6NG, with updates planned for the upcoming R&D event [10][20] Market Access and Coverage - Patient access to AUCATZYL is strong, with coverage secured for over 85% of total U.S. medical lives, and the company aims to authorize 60 treatment centers by the end of 2025 [5][8] - The National Comprehensive Cancer Network (NCCN) has included AUCATZYL in its Clinical Practice Guidelines for the treatment of adult patients with relapsed/refractory B-ALL [5]