Autolus Therapeutics (NASDAQ:AUTL) Chief Executive Officer Christian Itin said the company is seeing continued momentum from the U.S. launch of AUCATZYL, its CD19-targeting autologous CAR-T therapy for relapsed or refractory adult acute lymphoblastic leukemia, during a fireside chat at the Jefferies Global Healthcare Conference.
Itin said Autolus is now 18 months into the U.S. launch of AUCATZYL, which was approved at the end of 2024. The company reported $74 million in revenue in 2025 and is guiding for $120 million to $135 million this year, including $26 million in the first quarter.
Real-World Data Supports Launch Momentum
Itin highlighted real-world data collected by the ROCCA consortium and presented at the ASTCT meeting in February. He said the data confirmed the clinical outcomes seen in the trial that supported approval and, in some respects, looked “somewhat better.”
According to Itin, the real-world data showed no high-grade cytokine release syndrome, high-grade neurological toxicities in 3% of patients, and any form of neurological toxicity in less than 20% of patients. He also said the consortium reported a complete remission rate of more than 90% in the real-world setting.
Itin said physicians are beginning to use AUCATZYL in patients who previously may not have been considered for CAR-T therapy, including older patients, those with more comorbidities and patients with very low disease burden.
Autolus currently has about 76 U.S. centers licensed to deliver the product and expects to reach the mid-80s by the end of the year. Itin said growth is less about adding centers and more about deepening use within existing centers by increasing physician familiarity and confidence.
Physician Adoption and Commercial Strategy
Itin said the company is focused on repeat use by physicians, since CAR-T therapy is a one-time intervention for patients. He described three categories of physicians: older physicians trained primarily in stem cell transplant, younger physicians familiar with CAR-T therapy and an intermediate group more focused on frontline treatment with chemotherapy and other agents.
For transplant-focused physicians, Itin said adoption often begins with transplant-ineligible patients. As physicians gain experience with the product’s safety and efficacy, they may begin using it in broader patient groups. He said younger physicians familiar with CAR-T tend to transition more quickly to a safer product.
When asked what percentage of physicians reuse the product, Itin said reuse is occurring “in the majority,” with timing affected by the pace of center onboarding.
Itin also said AUCATZYL’s safety profile is important not only to physicians but also to hospital administrators, because avoiding high-grade toxicities can reduce intensive care resource use and improve hospital economics.
U.K. Launch and European Market Dynamics
Autolus launched AUCATZYL in the U.K. at the beginning of the year. Itin said the National Institute for Health and Care Excellence concluded the product was cost-efficient for the National Health Service and allowed it to move directly into routine commissioning without additional data generation.
He said adoption in the U.K. may be faster than in the U.S. because CAR-T treatment decisions for ALL patients are reviewed by a panel of eight physicians, compared with the U.S. model where Autolus must engage individual physicians at each institution.
Itin said the company may begin breaking out U.K. sales in the second year of launch, depending on development, and possibly earlier. He added that Autolus has European approval, but reimbursement and health economic models vary by country and remain a challenge, particularly for single-arm studies in small indications with large treatment effects.
Autolus has not yet guided for European sales, which Itin said remains premature.
Margins, Pediatrics and Frontline Expansion
Itin said Autolus had previously expected to turn gross margin positive in 2026 but achieved that milestone in the first quarter. He attributed the improvement to manufacturing more products with the same or slightly fewer staff, reducing fixed cost and labor cost per product.
“When we look from 2025-2026, we are going to double the amount of products that we’re actually manufacturing,” Itin said.
He said Autolus believes it can serve even the peak U.S. market with its current infrastructure and staffing levels.
Beyond adult relapsed or refractory ALL, Autolus is pursuing expansion opportunities. Itin said investigator-sponsored studies are underway in frontline consolidation and frontline use, with the goal of potentially reducing reliance on a 36-month high-dose chemotherapy regimen. The company also has a pivotal study ongoing in pediatric patients and previously reported a complete remission rate above 90% in that population at ASH.
Autoimmune Programs and Progressive MS
Itin also discussed Autolus’ autoimmune work, including the CARLYSLE study in severe systemic lupus erythematosus patients, many with lupus nephritis. He said treated patients showed “massive improvement,” no neurological toxicities and a rebound of B cells with normal composition and no autoreactivity. More data are expected at ACR later this year.
The company is also running the LUMINA pivotal study in lupus nephritis and the BOBCAT study in progressive multiple sclerosis. Itin said the rationale for BOBCAT is based on AUCATZYL’s ability to cross the blood-brain barrier and target CD19-positive B cells in the central nervous system.
He said the BOBCAT study is enrolling, with an early view expected by the end of the year and a more robust data set expected during next year.
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.
