On March 27, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported its operational and financial results for the fourth quarter and full year ended December 31, 2025.
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"Autolus had a strong first year of launch of AUCATZYL in the US building a market leading position in adult patients with relapsed or refractory B-ALL and demonstrating strong commercial execution, including reliable, high-quality product delivery with consistent turn-around time. Parallel to the launch, the ROCCA consortium collected real world data from approximately 60% of the commercial patients treated with AUCATZYL. Recently reported data confirm a high level of clinical activity without inducing high grade CRS and only 3% of patients experiencing high grade ICANS. We expect this positive customer experience will be a key driver for the future growth of AUCATZYL," said Dr. Christian Itin, Chief Executive Officer of Autolus.
Dr. Itin continued, "Our focus in 2026 will be on driving adoption of AUCATZYL in the US, launching in the UK and expanding the utility of obe-cel in additional indications while leveraging our established commercial and manufacturing capabilities. Based on regulatory feedback we are executing two compact pivotal studies: CATULUS in pediatric r/r B-ALL and LUMINA in severe lupus nephritis patients. In addition, we are exploring the utility of obe-cel in progressive MS patients in the Phase 1 BOBCAT study. Clinical data updates are planned for long-term follow up of the Phase 1 CARLYSLE data in severe SLE patients, initial clinical experience in light chain amyloidosis from the ALARIC study with AUTO8 and initial data from the BOBCAT study by the end of 2026."
Product and Pipeline Updates:
AUCATZYL Launch
Autolus reported net product revenue of $23.3 million* for the three months ended December 31, 2025, and $74.3 million* for the year ended December 31, 2025, driven by U.S. sales.
Following a successful National Institute for Health and Care Excellence (NICE) evaluation, AUCATZYL launched in the UK in January 2026 and is now available under routine commissioning.
Data from the ROCCA (Real-World Outcomes Collaborative for CAR T in Adult ALL) consortium database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025 and the TANDEM meeting in February 2026. Real-world data show consistency in both safety and efficacy compared to the FELIX clinical trial that was the basis for regulatory approvals. The ROCCA Consortium registry covers approximately 60% of U.S. commercial patients at a data cutoff of January 5, 2026.
Obe-cel data in pediatric r/r B-ALL
Preliminary data from the CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2025. Obe-cel demonstrated high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%. Low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were observed, consistent with obe-cel’s adult safety profile. The Phase 2 portion of the trial is underway and Autolus expects to report data at the end of 2027.
In October 2025, the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL. The RMAT designation is a program created under the 21st Century Cures Act to accelerate development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.
Obe-cel in lupus nephritis
Data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) were reported at the American College of Rheumatology (ACR) Convergence 2025 and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. All patients show deep B-cell depletion after infusion, suggesting an immune reset. No ICANS or high-grade CRS were observed in the nine patients evaluable for safety.
Data support progressing obe-cel as a treatment for LN and 50 million cells was selected as the recommended Phase 2 dose.
Autolus has previously aligned with the US Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling and the Company expects to report data in 2028.
Obe-cel in progressive multiple sclerosis
Autolus has advanced obe-cel into initial clinical development to explore treatment in progressive MS. The first patient in the BOBCAT trial was dosed in October 2025. The Phase 1 trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. The Company expects to report initial data from the trial at the end of 2026 and full data in 2027.
AUTO8 in AL-Amyloidosis
The first patient was dosed in the Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis and initial data is expected to be reported at the end of 2026.
Q4 2025 Operational Updates:
In the fourth quarter of 2025, Autolus initiated an overall manufacturing life cycle plan to facilitate additional cost reductions and gross margin improvements as the Company plans to expand obe-cel into new indications and pursue larger market opportunities. The initiatives are focused on 1) optimizing the Company’s current manufacturing operating model; 2) enhancing automation opportunities for the Company’s existing manufacturing process; and 3) developing a next-generation manufacturing platform with a step change in the cost and capacity profile. The Company plans to provide a detailed update on these plans in mid-2026.
Outlook:
For 2026, the Company continues to project AUCATZYL net product revenue of between $120 million to $135 million.
Increasing patient numbers in 2026 are expected to improve manufacturing plant utilization and together with operational efficiencies, Autolus expects a shift to positive gross margin in 2026.
Based on current operating plans, including anticipated AUCATZYL net revenues, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q4 2027.
Summary of Anticipated News Flow:
Longer-term follow up data from CARLYSLE trial
Year End 2026
Initial clinical data from BOBCAT Phase 1 trial in progressive MS Year End 2026
Initial clinical data from ALARIC Phase 1 trial in AL amyloidosis
(UCL collaboration) Year End 2026
BOBCAT trial progressive MS Phase 1 full data 2027
CATULUS trial pediatric Phase 2 data Year End 2027
LUMINA trial LN Phase 2 data 2028
ALL: acute lymphoblastic leukemia
SLE: systemic lupus erythematosus
LN: lupus nephritis
MS: multiple sclerosis
ALA: light-chain amyloidosis
Virtual Investor Event: Spotlight on Acute Lymphoblastic Leukemia (ALL) Program
April 8, 2026
1:00pm EDT / 6:00pm BST
A live webcast of the event will be available on the investor relations section of the Autolus website: View Source
Financial Results for the Quarter Ended December 31, 2025
Product revenue, net for the three months ended December 31, 2025, was $23.3 million*.
Cost of sales increased from $11.4 million to $25.3 million for the three months ended December 31, 2025, compared to the same period in 2024. This increase was primarily due to product sales in Q4 2025 and to the timing of commercial manufacturing activity expenses upon FDA approval of AUCATZYL in November 2024. Additionally, cost of sales in Q4 2025 includes cancelled orders in the period, patient access program product, inventory reserves and write-offs and third-party royalties for certain technology licenses.
Research and development expenses increased to $35.6 million from $30.8 million for the three months ended December 31, 2025, compared to the same period in 2024. This change was primarily due to an increase in research and development activities including clinical trial costs and a reduction in the UK R&D tax credit, partially offset by commercial manufacturing-related employee and infrastructure costs shifting to cost of sales and inventory.
Selling, general and administrative expenses increased to $35.8 million from $33.7 million for the three months ended December 31, 2025, compared to the same period in 2024. This increase was primarily due to salaries and other employment-related costs, driven by increased headcount supporting commercialization activities.
Loss from operations for the three months ended December 31, 2025, was $72.5 million, as compared to $75.9 million for the same period in 2024.
Net loss was $90.3 million for the three months ended December 31, 2025, compared to $27.6 million for the same period in 2024. Basic and diluted net loss per ordinary share for the three months ended December 31, 2025, totaled $(0.34), compared to basic and diluted net loss per ordinary share of $(0.10) for the same period in 2024.
Cash, cash equivalents and marketable securities at December 31, 2025, totaled $300.7 million, as compared to $588.0 million at December 31, 2024. The decrease was primarily driven by net cash used in operating activities and impacted by a delayed cash receipt of approximately $18.6 million in the Company’s 2023 R&D tax credit expected from the UK HMRC.
(Press release, Autolus, MAR 27, 2026, View Source [SID1234663974])