On November 12, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported its operational and financial results for the third quarter ended September 30, 2025.
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"Through three quarters of launch, we are encouraged by our progress to increase the overall market in r/r B-ALL, reaching patients who previously may not have been considered for CAR T therapy. With mounting experience we see physician enthusiasm for AUCATZYL increasing, validated by real world data from the ROCCA Consortium to be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December," said Dr. Christian Itin, Chief Executive Officer of Autolus. "Despite an expected temporary lag in Q3 sales based on the change in CMS reimbursement policy that occurred in Q2, we executed well on new patient starts and project a strong full year of sales."
Dr. Itin continued, "Building on our strong commercial and manufacturing performance, we enter our next phase of growth for obe-cel focused on three key objectives. First, increasing market share within the indicated adult ALL population; second, based on strong Phase 1 data sets we are conducting potential pivotal studies in pediatric ALL and in severe lupus nephritis to broaden the utility and commercial opportunity of obe-cel; and finally, we continue to innovate on manufacturing technology as a foundation for further expansion of access to CAR T therapies."
Product and Pipeline Updates:
AUCATZYL Launch
Autolus reported net product revenue of $21.1 million for the three months ended September 30, 2025 and deferred revenue of $7.6 million as of September 30, 2025.
The Company has 60 centers fully activated in the U.S. as of November 12, 2025, achieving the target of 60 activated centers prior to year-end.
Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total U.S. medical lives.
Data from the ROCCA (Real-World Outcomes Collaborative for CAR T in Adult ALL) database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL (obecabtagene autoleucel) and TECARTUS (brexucabtagene autoleucel) for relapsed acute lymphoblastic leukemia with r/r ALL will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Obe-cel data in pediatric r/r B-ALL
Data from the ongoing Phase Ib/II CATULUS study evaluating the safety and efficacy of obe-cel in patients under 18 years with CD19-positive r/r B-ALL or B-cell Non-Hodgkin Lymphoma (NHL) will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data show the safety profile of obe-cel in pediatric patients is consistent with that previously reported in adults, with low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Overall response rate (ORR) was high at 95% and nearly 90% of responders had ongoing remission at data cut-off. Additional data will be presented in a poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting on December 7, 2025, from 6:00 – 8:00pm ET.
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 (LN)
Data from the Phase 1 CARLYSLE clinical trial were presented on October 28, 2025, at the American College of Rheumatology (ACR) Convergence 2025. Data in severe refractory systemic lupus erythematosus (srSLE) suggests obe-cel is well tolerated with no ICANS or high-grade CRS. Preliminary efficacy data demonstrate achievement of definition of remission in SLE (DORIS) in 83% (n=5/6) of patients and complete renal response (CRR) in 50% (n=3/6) of patients. All responses and remissions are ongoing with no evidence of disease activity at a median follow up of 8.9 months (range 6-13.8 months).
Additional findings from the ongoing CARLYSLE study will be presented in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025 on December 8, 2025, at 11:30am ET. Data show the B-cell reconstitution profiles suggest that obe-cel may induce a reset of pathologic autoimmunity. Updated Phase 1 data with longer follow-up, and data in patients who received 100×106 CAR T-cells will be presented.
The Company has previously aligned with the FDA on the Phase 2 trial design and potential registrational path to approval. Data to date supported progressing into the Phase 2 LUMINA trial. The first patient is expected to be dosed prior to year-end 2025.
Obe-cel in progressive MS
Autolus is advancing obe-cel into initial clinical development 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 multiple sclerosis. The primary endpoint is to assess safety and tolerability of obe-cel. Key secondary endpoints include evaluating the preliminary efficacy of obe-cel using change from baseline in standard efficacy measures.
Early-stage pipeline programs and collaborations
In November 2025, Moderna announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, an investigational mRNA-based T-cell engager for participants with relapsed or refractory multiple myeloma. mRNA-2808 utilizes an Autolus proprietary binder that was licensed to Moderna in 2022.
Long term follow up from the AUTO8 MCARTY study in multiple myeloma will be presented in a poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting:
Abstract ID: abs25-14286
Title: CAR-T cells co-targeting BCMA and CD19 in RRMM: Results from the UKMRA Phase 1 MCARTY trial in relapsed refractory multiple myeloma
Date: December 7, 06:00 PM – 08:00 PM EST
Location: OCCC – West Halls B3-B4
Presenting Author: Lydia Lee, MBBS, MRCP, MRCPath (Haem), PhD
The first patient in the AUTO8 ALARIC study in AL Amyloidosis is expected to be dosed prior to year-end 2025.
Autolus’ translational programs with UCL continue to fuel its early-stage pipeline, providing a cost-efficient path to development to support long-term growth.
Operational Updates:
Autolus announced leadership team changes to support the next phase of commercial growth, margin improvement and market expansion.
Cintia Piccina was appointed U.S. Chief Commercial Officer and Country General Manager to lead ongoing momentum in AUCTAZYL U.S. launch and drive future growth. Cintia brings to Autolus extensive cellular therapy experience having led teams that successfully launched and commercialized multiple products in Novartis, Bluebird/2seventy bio, Allovir and Adaptimmune, where she was most recently the Chief Commercial Officer.
Miranda Neville was appointed Chief Technical Officer to drive manufacturing optimization, succeeding David Brochu who will continue as an advisor. Ms. Neville joined Autolus in 2018 from the consulting firm AllianceBIO where she spent four years as a Partner and supported several clinical stage and commercial biopharmaceutical companies. Ms. Neville began her career at Human Genome Sciences (HGS). She spent 10 years at HGS in a variety of roles including Manufacturing, Engineering & Program Management, prior to its acquisition by GlaxoSmithKline.
Patrick McIlvenny was appointed Senior Vice President, Finance and Chief Accounting Officer. Before joining Autolus, Mr. McIlvenny served as Senior Vice President, Chief Accounting Officer for Horizon Therapeutics plc, until the acquisition of Horizon by Amgen, and in various finance roles of increasing responsibilities at Ardagh Group S.A and Elan Corporation plc. Prior to joining Elan, Mr. McIlvenny worked with PricewaterhouseCoopers and Deloitte. Mr. McIlvenny is a Fellow of the Institute of Chartered Accountants in England and Wales.
Dr. Itin commented, "Our new team members bring a breadth of leadership experience and will focus on market growth, strategic planning and operational excellence driving growth and efficiency of the ALL business. We are grateful to our prior team members who were instrumental in setting our organization on the right course for a successful launch."
Summary of Anticipated News Flow:
ALL: Initial clinical data from CATULUS trial in pediatric ALL December 7, 2025
SLE: Longer-term follow up data from CARLYSLE trial
December 8, 2025
LN: Expect to dose first patient in Phase 2 LUMINA trial By year-end 2025
ALA: Expect to dose first patient in Phase 1 ALARIC trial in AL amyloidosis By year-end 2025
ALL: acute lymphoblastic leukemia
SLE: systemic lupus erythematosus
LN: lupus nephritis
ALA: light-chain amyloidosis
Financial Results for the Quarter Ended September 30, 2025
Product revenue, net for the three months ended September 30, 2025, was $21.1 million. Deferred revenue balance at September 30, 2025, was $7.6 million, representing product that was shipped and received by centers but not yet dosed.
Cost of sales for the three months ended September 30, 2025, totaled $28.6 million. This amount includes the cost of all commercial product delivered to the authorized treatment centers, including product delivered but not yet recorded as product revenue which is captured as deferred revenue. Additionally, cost of sales includes any cancelled orders in the period, patient access program product, inventory reserves and write-offs and 3rd party royalties for certain technology licenses.
Research and development expenses decreased from $40.3 million to $27.9 million for the three months ended September 30, 2025, compared to the same period in 2024. This change was primarily due to commercial manufacturing-related employee and infrastructure costs shifting to cost of sales and inventory.
Selling, general and administrative expenses increased from $27.3 million to $36.3 million for the three months ended September 30, 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 September 30, 2025, was $71.6 million, as compared to $67.9 million for the same period in 2024.
Net loss was $79.1 million for the three months ended September 30, 2025, compared to $82.1 million for the same period in 2024. Basic and diluted net loss per ordinary share for the three months ended September 30, 2025, totaled $(0.30), compared to basic and diluted net loss per ordinary share of $(0.31) for the same period in 2024.
Cash, cash equivalents and marketable securities at September 30, 2025, totaled $367.4 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 $20.1 million in the Company’s 2023 R&D tax credit expected from the UK HMRC.
Autolus estimates that, with its current cash and cash equivalents and marketable securities, the Company is well capitalized to to drive the launch and commercialization of obe-cel in r/r B-ALL and to generate data in the LN and pALL potential pivotal trials and MS Phase 1 trial
Financial Results for the Period Ended September 30, 2025
Selected Consolidated Balance Sheet Data
(In thousands)
September 30
December 31
2025
2024
Assets
Cash and cash equivalents $ 86,124 $ 227,380
Marketable securities – Available-for-sale debt securities $ 281,289 $ 360,643
Total current assets $ 514,577 $ 660,929
Total assets $ 661,947 $ 782,725
Liabilities and shareholders’ equity
Total current liabilities $ 83,071 $ 60,743
Total liabilities $ 396,495 $ 355,400
Total shareholders’ equity $ 265,452 $ 427,325
Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)
Three Months Ended
September 30, Nine Months Ended
September 30,
2025
2024
2025
2024
Product revenue, net $ 21,144 $ — $ 51,049 $ —
License revenue 50 — 50 10,091
Cost and operating expenses:
Cost of sales (28,643) — (71,039) —
Research and development expenses, net (27,892) (40,323) (82,056) (107,606)
Selling, general and administrative expenses (36,280) (27,330) (96,079) (67,410)
Loss on disposal of property and equipment — (223) (3) (223)
Impairment of operating lease right-of-use assets and related property and equipment — — — (414)
Loss from operations (71,621) (67,876) (198,078) (165,562)
Total other (expenses) income, net (6,965) (14,196) 4,037 (27,428)
Net loss before income tax (78,586) (82,072) (194,041) (192,990)
Income tax expenses (532) (22) (3,155) (66)
Net loss attributable to ordinary shareholders (79,118) (82,094) (197,196) (193,056)
Other comprehensive (loss) income, net of tax (5,782) 27,010 24,254 28,094
Total comprehensive loss $ (84,900) $ (55,084) $ (172,942) $ (164,962)
Basic and diluted net loss per ordinary share $ (0.30) $ (0.31) $ (0.74) $ (0.77)
Weighted-average basic and diluted ordinary
shares 266,141,431 266,084,589 266,136,518 255,480,521
Conference Call
Management will host a conference call and webcast today at 8:30am EST/1:30pm GMT to discuss the company’s financial results. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website at View Source
(Press release, Autolus, NOV 12, 2025, View Source [SID1234659806])