Autolus Therapeutics (NASDAQ:AUTL) Chief Executive Officer Christian Itin told conference attendees the company is entering its second year as a commercial-stage business following the launch of its first product, obe-cel, a CD19 CAR-T therapy approved for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Itin said the company generated $75 million in revenue in the first year of launch and “achieved market leadership very quickly,” reaching that position by the second quarter after launching at the beginning of last year.
Launch progress and 2026 revenue guidance
In the U.S., Autolus is currently active in “approximately 70 centers,” with plans to expand to “80+ centers” during the course of this year. Itin emphasized that CAR-T delivery requires each treatment center to be qualified and added to a license, making expansion a process-driven effort.
U.K. and Europe: approvals and market access
Itin said Autolus has also obtained approvals in the U.K. and Europe. In the U.K., he highlighted a positive NICE review, which he described as a key milestone for market access. He said obe-cel was deemed cost-efficient and entered routine commissioning rather than the Cancer Drugs Fund, meaning no additional data collection was required. The company launched the product in the U.K. at the end of last year.
On the European commercial rollout, Itin said Autolus is negotiating market access and is not currently guiding to any revenue in Europe, noting the company will “need to see how that goes.”
Manufacturing performance and margin focus
Because obe-cel is an autologous CAR-T, Itin described manufacturing as central to execution. Autolus operates its own manufacturing facility in the U.K., north of London, and Itin said the company achieved a manufacturing success rate substantially above 90% in the first year of launch, which he characterized as unusual for a newly launched CAR-T product. He also said Autolus has no capacity limitations at present.
He explained that the company ran its operation at full pace in the first half of last year to establish a stable delivery platform and is now incorporating learnings to optimize manufacturing. That work includes reducing hours per product, improving the supply chain, and pursuing “advanced forms of automation” as part of a next-generation manufacturing platform. Itin said gross margin improvement will be a major focus for the next 24 to 36 months.
Real-world ROCCA data highlighted safety and response
Itin pointed to real-world evidence from the ROCCA Consortium, a group of about 45 U.S. centers that collect outcomes data on acute leukemia patients. He said approximately 60% of Autolus patients were captured in the ROCCA database.
In comparing the pivotal FELIX trial (which supported approval) with ROCCA real-world experience, Itin emphasized safety metrics and response:
- Zero patients with high-grade cytokine release syndrome (CRS) in the ROCCA dataset, according to Itin.
- 3% of patients experienced high-grade ICANS, with 17% experiencing any ICANS.
- Itin said the company observed zero treatment-related mortality with obe-cel.
- He reported an overall response rate “above 90%” in the real-world setting, versus 78% in the FELIX study.
Itin said this safety and efficacy profile has supported adoption, noting the company reached market leadership despite initially having “a fraction of the centers” delivering the product.
Pipeline expansion into pediatrics and autoimmune disease
Beyond adult relapsed/refractory B-ALL, Itin outlined multiple development programs intended to expand the “obe-cel franchise.” Autolus is running two pivotal studies—one in pediatric ALL and one in lupus nephritis—as well as an exploratory study in progressive multiple sclerosis (MS).
For pediatrics, Itin said Autolus presented a phase I experience from its phase I/II pivotal study at ASH late last year and has moved into the phase II portion enrolling an additional 30 patients in a single-arm design. He said one patient experienced both high-grade CRS and high-grade ICANS, while overall safety appeared similar to adult experience. He added that, except for one patient, all responded and achieved complete remission in the dataset shown.
In autoimmune disease, Itin described the rationale as the ability of CD19 CAR-T to deeply reset the CD19-positive B-cell compartment, including plasmablasts. He said Autolus has more than 500 patients of safety data with obe-cel and is using the same product in oncology and autoimmune indications, which he said supports development. He also argued that having established commercial manufacturing reduces the capital required to expand into new indications.
Discussing early data from the CAROUSEL phase 1 experience in severe SLE with organ involvement, Itin said the median SLEDAI score was 17, which he described as the highest reported among studies to date. He reported that half of patients had grade 1 CRS (fever) manageable with paracetamol and that no patients experienced ICANS. He said five of six patients achieved a DORIS response (including steroid reduction to physiologic levels), and three of six achieved complete renal response.
For lupus nephritis, Itin said the pivotal LUMINOUS study is a single-arm, 30-patient trial designed for full approval in refractory patients post-CD20 monoclonals and post-calcineurin inhibitors. He estimated the refractory lupus nephritis population at 25,000 to 35,000 patients in the U.S. and called it a meaningful opportunity compared with the roughly 1,600 adult relapsed/refractory B-ALL patients in the U.S. He also described progressive MS as a large unmet-need area, citing the ability of CAR-T cells to cross the blood-brain barrier and noting early data from the BOBCAT MS study are expected by end of this year or early next year, with more mature data next year.
Looking ahead, Itin listed upcoming milestones that include longer-term follow-up from the initial SLE experience (which included adolescents 12 and older), early data from the MS study, early data from a light chain amyloidosis program (AUTO8), and longer enrollment and readout timelines for pivotal pediatric and lupus studies extending into 2027 and 2028.
About Autolus Therapeutics (NASDAQ:AUTL)
Autolus Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of next-generation, programmed T cell therapies for the treatment of cancer. The company leverages proprietary technologies to engineer autologous T cells that target and eradicate tumor cells, with the aim of improving safety, efficacy and durability over existing cell therapies. Its R&D platform integrates antigen receptor design, gene editing and manufacturing optimization to generate candidates tailored for specific hematologic malignancies and solid tumor indications.
The company’s leading pipeline candidates include AUTO1, an optimized CD19-targeted CAR-T therapy for relapsed or refractory acute lymphoblastic leukemia, and AUTO3, a dual-targeted CD19/22 CAR-T program in development for diffuse large B-cell lymphoma.
