Autolus Therapeutics (NASDAQ:AUTL) executives highlighted a “very good first year of launch” for AUCATZYL during the company’s fourth-quarter and full-year 2025 financial results call, pointing to $74.3 million in revenue recognized in 2025, expanded U.S. treatment-center activation, and early real-world outcomes that management said aligned well with prior clinical trial results.
Commercial launch update and 2026 outlook
Chief Executive Officer Dr. Christian Itin said the company ended 2025 with 67 activated centers and plans to expand its commercial footprint to more than 80 activated centers by the end of 2026. Autolus reiterated its 2026 net product revenue guidance of $120 million to $135 million and said it expects to shift to positive gross margins in 2026.
In response to analyst questions, management said 2026 revenue guidance includes contributions from the U.S. and U.K. but that it does not plan to break out the expected U.K. contribution. Itin characterized the U.K. as “substantially smaller” than the U.S. and said Autolus does not expect a major contribution yet given the early stage of the U.K. launch. For the EU, Itin said the company does not expect revenue contributions from other EU countries in 2026 and is in discussions with market access authorities, emphasizing the need to enter markets in an “economically sensible” way.
Real-world ROCCA data in adult ALL
Itin reviewed data gathered by the ROCCA consortium (Real-World Outcomes Collaborative of CAR-T in Adult ALL), which collected outcomes on patients treated with obe-cel at participating institutions. He said 96 patients were authorized, with 91 receiving infusions; five patients did not receive an infusion due to medical reasons such as progressive disease, infection, or a lineage switch with loss of CD19. All 91 infused patients received both infusions.
For the analysis conducted at the beginning of 2026, 84 patients were evaluable for a day 28 response assessment, with a median follow-up of 137 days from first infusion. Itin said the dataset represented about 60% of U.S. commercial patients treated during the first year of launch.
Management emphasized that safety observations in the real-world setting were consistent with prior results in the FELIX study. Itin said:
- About 59% of patients experienced grade 1 or grade 2 cytokine release syndrome (CRS), with no grade 3 or higher CRS reported.
- Seventeen percent experienced grade 1 or grade 2 ICANS, and 3% experienced grade 3 ICANS.
On efficacy, Itin described the day 28 assessment as “early data” but said the real-world complete remission rate was about 92%, which he said was similar to mature FELIX data at three months and appeared improved versus the day 28 assessment in FELIX.
Asked whether ROCCA results could influence physician behavior, Itin said building market share depends on increasing physician confidence and experience in an incidence-driven, one-time therapy market. He said Autolus is working not only with transplant and CAR-T specialists, but also with hematologists involved in frontline and early relapse care. He added that the company is working to increase penetration from what he estimated as “somewhere around the 10% range” toward levels seen with blinatumomab (Blincyto), which he cited as a reference point for potential penetration.
Pipeline and upcoming clinical milestones
Autolus outlined efforts to broaden obe-cel beyond adult acute lymphoblastic leukemia. Itin discussed three key programs:
- CATULUS (pediatric ALL): Autolus plans to expand the study with an additional 30 patients in the phase II portion, with centers active in the U.S., U.K., and Spain in collaboration with the Children’s Oncology Group. The study includes patients aged 0 to 18 years, with a minimum body weight of 6 kilograms and dosing of 1 million cells per kilogram as a single infusion. Itin said the study includes relapsed/refractory patients and a focus on certain first-line high-risk relapse patients who are currently excluded from access to CAR-T therapy. Autolus expects pivotal data by the end of 2027.
- CARLYSLE / LUMINA (systemic lupus and lupus nephritis): For CARLYSLE, Itin said the recommended phase II dose was selected as a 50 million-cell single infusion. In the 50 million-cell cohort with 11.4 months of follow-up, he said 5 of 6 patients achieved a DORIS response and 3 of 6 achieved complete renal remission, with no ICANS and no high-grade CRS. He also noted a reported median product persistence of three months and a median time to B-cell recovery of six months. For LUMINA, a single-arm 30-patient pivotal study in advanced lupus nephritis after failure of B-cell depleting antibodies and calcineurin inhibitors, Itin said enrollment is underway with activity in the U.S. and U.K. and Spain, with potential to add additional countries. Data are expected in 2028.
- BOBCAT (progressive multiple sclerosis): The phase I study is enrolling, with the first patient treated in October 2025. Itin said the company expects early data by the end of 2026 and full phase I data during 2027. In Q&A, he said Autolus will evaluate dose levels (starting at 100 million cells) and is focused initially on product properties such as expansion, safety, and evidence of CAR-T cells in cerebrospinal fluid, along with pharmacodynamic markers including B-cell depletion. He said it will likely be premature to draw conclusions on clinical outcomes early and that more meaningful assessment would come with longer follow-up in 2027.
Financial results and accounting update
Chief Financial Officer Rob Dolski reported net product revenue of $23.3 million in the fourth quarter of 2025, contributing to $74.3 million for the first full year of AUCATZYL sales. Autolus also recorded $1.0 million in license revenue in Q4 tied to a clinical milestone under its license and option agreement with Moderna, bringing total Q4 revenue to $24.3 million.
Dolski said the company refined its accounting treatment for product revenue and cost of goods sold. Going forward and for full-year 2025 reporting, Autolus plans to recognize the full value of product sales and associated cost of goods sold upon confirmation of second-dose administration for AUCATZYL, rather than a prior 50/50 split between first- and second-dose confirmations. He said the change has no material impact on existing or anticipated revenue and is intended to better align timing of revenue and costs.
Cost of sales was $25.3 million in Q4 2025 versus $11.4 million in Q4 2024, which Dolski attributed primarily to a full quarter of sales in 2025 compared with only partial commercial manufacturing expense recognition following FDA approval in November 2024. He also said Q4 2025 cost of sales included canceled orders, patient access program product, inventory reserves or write-offs, and third-party royalties for certain technology licenses.
Autolus reported R&D expense of $35.6 million for Q4 2025 (vs. $30.8 million in Q4 2024), driven by increased R&D activities including new clinical trial startups and a reduction in the U.K. R&D tax credit, partially offset by certain commercial manufacturing employee and infrastructure costs shifting into cost of sales and inventory. SG&A expense was $35.8 million (vs. $33.7 million), driven primarily by higher headcount supporting commercialization. Loss from operations was $72.5 million for the quarter, compared with $75.9 million in the prior-year period, and net loss was $90.3 million versus $27.6 million.
Cash, cash equivalents, and marketable securities totaled $300.7 million at December 31, 2025, down from $588.0 million a year earlier. Management attributed the decrease primarily to net cash used in operating activities and a delayed receipt of approximately £18.6 million related to a 2023 U.K. R&D tax credit expected from HMRC. The company reiterated that, based on current operating plans and anticipated AUCATZYL net revenues, it expects its cash position to fund operations into the fourth quarter of 2027.
Near-term events
Itin highlighted an April 8 virtual key opinion leader event focused on acute leukemia, featuring speakers from Memorial Sloan Kettering, Stanford, MD Anderson, and the University of Utah, including discussion of the ROCCA real-world experience and pediatric data from CATULUS. Looking ahead, Autolus expects longer-term follow-up from CARLYSLE by the end of 2026, initial data from the AUTO8 program in light chain amyloidosis (ALARIC) in collaboration with UCL, and early BOBCAT data by year-end 2026.
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.
