Autolus Therapeutics NASDAQ: AUTL reported higher first-quarter 2026 product revenue and said its commercial launch of AUCATZYL is gaining traction in the U.S. and U.K., while reiterating full-year revenue guidance for the cell therapy.
Chief Executive Officer Dr. Christian Itin said the company had a “very good first quarter,” with $26.2 million in revenue booked. He said Autolus is seeing “nice traction building” in the U.S. and in the early stages of its U.K. launch, where more than 10 centers are already active under the NHS access program.
Autolus maintained its 2026 guidance for AUCATZYL net product revenue of $120 million to $135 million, including contributions from the U.S. and U.K. markets. Itin said the company has about 73 U.S. centers active and expects to increase that number beyond 80 by the end of the year.
Gross Margin Turns Positive
Chief Financial Officer Rob Dolski said total net product revenue for the first quarter was $26.2 million, compared with $9 million in the first quarter of 2025. He said the quarter reflected U.S. sales and Autolus’ first quarter in the U.K. market, though the U.K. contribution was minimal because the launch is still early.
The company shifted to a positive gross margin in the quarter, with $1.6 million, compared with losses in prior quarters of 2025. Dolski said cost of sales totaled GBP 24.6 million, compared with GBP 18 million in the same period last year, primarily reflecting higher AUCATZYL sales.
Itin said gross margin improvement was driven by higher volume and operational changes, particularly at the company’s manufacturing plant. He said Autolus expects to produce twice as much product this year as last year with staffing “at or below” last year’s levels.
Itin said the company is targeting a 65% to 70% gross profit margin for the peak adult acute lymphoblastic leukemia, or ALL, business. In response to an analyst question, he said the company expects the ALL business to cross into profitability in 2028, though companywide profitability will depend on reinvestment levels.
Expenses, Cash Runway and Cost Reductions
Research and development expenses declined to GBP 21.2 million in the first quarter from GBP 26.7 million a year earlier. Dolski attributed the decrease primarily to lower development activity, including clinical trial and clinical manufacturing supply costs and capacity mobilization costs, mostly related to obe-cel.
Selling, general and administrative expenses rose to GBP 39.9 million from GBP 29.5 million in the prior-year quarter. Dolski said the increase was tied to salaries, employment-related costs and professional fees supporting commercialization in the U.S. and U.K., as well as one-time termination-related expenses from an operational efficiency and cost reduction initiative announced in April.
Loss from operations was GBP 59.5 million for the three months ended March 31, compared with GBP 65.2 million a year earlier. Net loss was GBP 71.6 million, compared with GBP 70.2 million in the first quarter of 2025.
Autolus ended the quarter with cash, cash equivalents and marketable securities of GBP 229.4 million, down from GBP 300.7 million at Dec. 31, 2025. Dolski said the company expects its current and projected cash resources, including anticipated AUCATZYL revenue, to fund operations into the fourth quarter of 2027.
AUCATZYL Adoption and Market Expansion
Itin said physician experience with AUCATZYL has been positive, pointing to data discussed at the Tandem Meetings as part of the Cell Therapy Consortium presentation. He said about 60% of commercial patients were represented in that data set, which showed no high-grade cytokine release syndrome, 3% high-grade ICANS and an overall response rate above 90%.
He also said the company is seeing use expand into older patients, patients with more comorbidities and patients with limited tumor burden. In response to analysts, Itin said most growth is coming from centers already active with the product, as more physicians within those centers gain experience and begin using it more broadly across the label.
Asked about U.K. rollout dynamics, Itin said the launch appears at least as fast as the initial U.S. launch and may be faster. He cited centralized decision-making within the U.K. system and NHS efforts to increase awareness of the treatment. Autolus said it does not plan to break out U.K. revenue initially, though Itin said the company may do so toward the end of the year.
Pipeline Updates Expected Through 2028
Autolus outlined several upcoming clinical milestones for obe-cel and related programs. Itin said the company expects longer-term follow-up from the CARLYSLE study in systemic lupus erythematosus by year-end 2026. He said the company is also expecting initial clinical data from the BOBCAT phase 1 study in progressive multiple sclerosis and initial data from the ALARIC phase 1 study of AUTO8 in light chain amyloidosis, conducted in collaboration with UCL.
The company expects full BOBCAT data in 2027. Itin said the initial multiple sclerosis readout this year is expected to focus on safety, pharmacodynamic and pharmacokinetic markers, including whether the product is present in cerebrospinal fluid. He said more meaningful information on disease scores is expected in 2027 after longer follow-up.
Autolus also expects pediatric phase 2 data from the CATULUS study by the end of 2027. Itin said the company has aligned with the FDA on protocol design and potential registration support. In lupus nephritis, the LUMINA phase 2 study is enrolling in the U.S. and certain European countries, with data expected in 2028. Itin said the trial is intended to enroll 30 refractory patients and that Autolus is not concerned about enrollment.
In multiple sclerosis, Itin said Autolus is exploring commercialization approaches that could include collaboration with a partner, given the larger and more distributed patient population.
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.
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