Autolus Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates
AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch progressing on track with 33 authorized treatment centers as of March 19, 2025, following US FDA approval on November 8, 2024
Obe-cel MHRA and EMA marketing authorizations expected in H2 2025
Initial six patients dosed in Phase 1 dose confirmation trial in Systemic Lupus Erythematosus (SLE)
Company to provide clinical development program updates, including plans for expansion in autoimmune diseases, at R&D investor event to be held on April 23rd
Conference call to be held today at 08:30 am EDT/12:30 pm GMT: conference call participants should pre-register using the link at the bottom of this press release
LONDON, March 20, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces its operational and financial results for the full year ended December 31, 2024.
"Reflecting on 2024, it was a year of strong execution leading to significant achievements for Autolus, including our strategic deal with BioNTech and corresponding financing to bolster our balance sheet, commencing GMP operations at our in-house CAR T manufacturing facility, and finishing the year with our first FDA approval and the commercial launch of AUCATZYL®," said Dr. Christian Itin, Chief Executive Officer of Autolus. "As a result, we were well positioned to attain our most important goal of bringing this transformative therapy to patients in need. Physician enthusiasm for AUCATZYL is high, demonstrated by the 33 treatment centers we now have fully authorized as of March 19, 2025. We're encouraged by our launch progress to date."
"As we begin 2025, we have two key objectives: execute on the commercial launch of AUCATZYL in adult ALL both in the U.S. and entering new markets; and establish the next wave of investments to expand the obe-cel opportunity, advance our clinical pipeline and drive future growth. We look forward to discussing our plans to continue to expand our clinical pipeline and strategy at our R&D event in April."
Key updates and anticipated milestones:
AUCATZYL® US launch
AUCATZYL was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia on November 8, 2024
AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program
In December 2024, the National Comprehensive Cancer Network® (NCCN) added AUCATZYL (obecabtagene autoleucel) to its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)
The US commercial launch progresses on track, with 33 centers authorized as of March 19, 2025 (versus the Company's initial target of 30 by the end of Q1 2025), covering approximately 60% of the target U.S. patient population
Patient access to AUCATZYL is progressing well, with coverage secured for greater than 85% of total U.S. medical lives
Autolus continues to expect to complete authorization of 60 treatment centers by the end of 2025, covering approximately 90% of the target patient population
Obe-cel in r/r adult B-ALL, The FELIX Study and regulatory updates
In December 2024, the New England Journal of Medicine published data from the pivotal Phase 1b/2 FELIX clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). The data from the trial demonstrate high rates of durable responses with low incidence of greater than Grade 3 immune-related toxicity
In February 2025, the FDA published a summary of the approval of AUCATZYL on JAMA Insights, citing the product's complete remission rate
Obe-cel is under regulatory review in both the EU and the U.K., and the Company expects to receive notification of approval status from the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) in H2 2025
Post period, Autolus submitted obe-cel for appraisal by the U.K. National Institute for Health and Care Excellence (NICE), and a decision is expected at the time of a potential MHRA approval
Autolus has presented updated data on obe-cel in adult ALL at the Society of Hematologic Oncology (SOHO) meeting in August 2024, the Lymphoma, Leukemia & Myeloma Congress in October 2024, the American Society of Hematology (ASH) Meeting in December 2024, and post-period at TANDEM 2025. The data presented at these conferences builds on previously published obe-cel data, highlighting its tolerability and long-term responses. In addition, a health economic cost model has been presented, directly comparing the cost of serious adverse events across various comparable CAR-T cell therapies.
Abstracts were accepted at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting being held in Florence, Italy, March 30 - April 2, 2025, and the British Society for Haematology Annual Meeting in Glasgow, UK, April 27-29, 2025. The abstracts include review of data on obe-cel in adult ALL and specifically, a sub analysis of patients 55 and older.
Obe-cel in B-cell mediated autoimmune diseases
The Phase 1 dose confirmation clinical trial (CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients is ongoing, with all six patients dosed. Autolus will present the initial data from this trial and development plans at its R&D event being held on April 23, 2025, and is targeting H2 2025 for the presentation of full data with longer term patient follow-up.
Early-stage pipeline programs and collaborations
Clinical programs AUTO8 and AUTO6NG are progressing, and the Company is planning updates for programs at its R&D event which will be held on April 23, 2025.
BioNTech's product option for AUTO1/22 was not exercised as a result of BioNTech's pipeline prioritization, and has expired as of February 8, 2025.
Q4 2024 Operational Updates:
The FDA approval for AUCATZYL triggered a $30 million milestone payment to Autolus from Blackstone in accordance with the terms of the collaboration agreement between the parties. In addition, Autolus has made a £10 million regulatory milestone payment to UCL Business Ltd. in accordance with the license agreement between the parties
The Nucleus, Autolus' proprietary CAR T manufacturing facility designed for 2,000+ batches per year, is now licensed by the FDA and MHRA to produce commercial supply.
2025 Expected News Flow:
Initial data from SLE Phase 1 study
23 April
Company R&D eventInitial data from PY01 trial of obe-cel in pediatric ALL
23 AprilH2 2025
Notification from UK and EU regarding approval in ALLSLE Phase 1 trial presentation at medical conference
H2 2025H2 2025
Financial Results for the Year Ended December 31, 2024
Cash, cash equivalents and marketable securities at December 31, 2024, totaled $588.0 million, as compared to $239.6 million at December 31, 2023. The increase was primarily driven by proceeds from the strategic collaboration with BioNTech and the Company's concurrent equity financing to bolster the balance sheet ahead of its U.S. commercial launch.
Loss from operations for the year ended December 31, 2024 was $241.4 million, as compared to $179.7 million for the year ended December 31, 2023.
Cost of sales totaled $11.4 million following the receipt of FDA approval for obe-cel. This amount represents the cost of commercially available plant capacity that will no longer be classified as research and development expense even though it was not associated with product sales in the period.
Research and development expenses increased from $130.5 million to $138.4 million for the year ended December 31, 2024, compared to the same period in 2023. This change was primarily due to increases in employee salaries and related costs, and manufacturing costs related to obe-cel, partially offset by a decrease in professional fees and facilities costs.
Selling, general and administrative expenses increased from $46.7 million to $101.1 million for the year ended December 31, 2024, compared to the same period in 2023. This increase was primarily due to salaries and other employment-related costs, driven by increased headcount supporting U.S. commercialization activities.
Net loss was $220.7 million for the year ended December 31, 2024, compared to $208.4 million for the same period in 2023. Basic and diluted net loss per ordinary share for the year ended December 31, 2024, totaled $(0.86), compared to basic and diluted net loss per ordinary share of $(1.20) for 2023.
Autolus estimates that, with its current cash and cash equivalents and marketable securities, it is well capitalized to drive the launch and commercialization of obe-cel in r/r adult B-ALL in the U.S., UK and EU, as well as to advance its pipeline development plans, which includes providing runway to data in the first pivotal clinical trial of obe-cel in autoimmune disease.
Financial Results for the Year Ended December 31, 2024Selected Consolidated Balance Sheet Data(In thousands)
December 31,
2024
2023
Assets
Cash and cash equivalents
$
227,380
$
239,566
Marketable securities - Available-for-sale debt securities
$
360,643
$
—
Total current assets
$
660,929
$
275,302
Total assets
$
782,725
$
375,381
Liabilities and shareholders' equity
Total current liabilities
$
60,743
