Autolus Therapeutics announced it expects preliminary unaudited net product revenue from AUCATZYL (obecabtagene autoleucel; obe-cel) of about $24 million for the fourth quarter of 2025 and about $75 million for the full year, marking its first year of commercial sales following the CD19 CAR T therapy’s U.S. approval in November 2024.
The commercial-stage cell therapy developer also issued 2026 AUCATZYL net product revenue guidance of $120 million to $135 million, citing a U.S. launch that it said has expanded to more than 60 treatment centers and established consistent turnaround times for product delivery.
Autolus said independent real-world data collected by the ROCCA consortium in adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and presented at the 2025 American Society of Hematology meeting supported AUCATZYL’s clinical activity and safety profile in line with prior trial results, which the company said should help drive further uptake in 2026.
Outside the U.S., Autolus said it has secured approvals in the U.K. and European Union and completed pricing and reimbursement work with the National Institute for Health and Care Excellence, enabling a U.K. commercial launch in December 2025 under routine commissioning.
Alongside the commercial update, Autolus outlined 2026 priorities focused on expanding AUCATZYL revenue, improving gross margin through manufacturing cost reductions, and advancing multiple obe-cel studies aimed at broadening use into pediatric hematologic cancers and autoimmune disease.
In pediatrics, Autolus said preliminary Phase 1 data from the CATULUS study in pediatric r/r B-ALL showed an overall response rate of 95.5%, with low rates of high-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome consistent with the adult safety profile. The company said it is progressing into the Phase 2 portion of the trial and expects full enrollment in the first half of 2027.
In autoimmune disease, Autolus highlighted Phase 1 CARLYSLE data in severe refractory systemic lupus erythematosus, reporting deep B-cell depletion after infusion and no ICANS or high-grade CRS among nine patients evaluable for safety. Based on those results, the company selected a 50 million cell dose as the recommended Phase 2 dose for lupus nephritis and said its Phase 2 LUMINA trial is now enrolling, following prior alignment with the FDA on trial design and a potential registrational path.
Autolus is also testing obe-cel in progressive multiple sclerosis in the Phase 1 BOBCAT study, with the first patient dosed in October 2025 and initial data expected by the end of 2026. Separately, the company said the first patient has been dosed in the Phase 1 ALARIC trial of AUTO8 in light-chain (AL) amyloidosis, with initial data also expected by the end of 2026.
On operations, Autolus said higher patient volumes should improve manufacturing utilization and, together with efficiency initiatives, support a shift to positive gross margin in 2026. The company said it has launched a manufacturing lifecycle plan that includes optimizing its operating model, adding automation, and developing a next-generation manufacturing platform, with a more detailed update expected in mid-2026.
Autolus said it plans to report full fourth-quarter and full-year 2025 financial results in March 2026, and that its current and projected cash, cash equivalents and marketable securities are expected to fund operations into the fourth quarter of 2027.
KEY QUOTES:
“We had a successful launch of AUCATZYL in the US with full year sales well above expectations and more than 60 centers offering treatment. We established reliable, high-quality product delivery with short and consistent turn-around time. Parallel to the launch and independent from the Company, the ROCCA consortium collected real-world data for AUCATZYL in adult r/r B-ALL patients and presented initial data at ASH 2025. The real-world data confirmed a high level of clinical activity and a favorable safety profile for AUCATZYL consistent with prior clinical trial results, and we believe this positive customer experience will be a key driver for the future growth of AUCATZYL in 2026.”
“In addition to our launch of AUCATZYL in the US, we obtained regulatory approvals in the UK and EU. We successfully navigated the challenging pricing and reimbursement process with NICE, establishing cost effectiveness of AUCATZYL for the NHS and initiating our commercial launch in the UK in December under routine commissioning – a first for a CAR T therapy in the UK.”
“Our 2026 commercial focus for AUCATZYL is to build on the strong center presence and positive physician experience to drive top line growth, while improving margins by reducing our manufacturing costs per batch. Our development focus is on progressing our pivotal pediatric ALL CATLULUS and lupus nephritis LUMINA studies and the exploratory BOBCAT study in progressive multiple sclerosis. Our plans for innovation will focus on manufacturing technology and European market access.”
Dr. Christian Itin, Chief Executive Officer, Autolus Therapeutics
