Autolus Therapeutics (NASDAQ:AUTL) raised its full-year AUCATZYL sales outlook after third-quarter revenue nearly doubled from a year earlier, as the company reported improved manufacturing margins and faster-than-planned treatment center onboarding.
The company expects 2026 net product revenue from the U.S. and U.K. combined to reach at least $150 million, up from its previous forecast of $140 million to $150 million. Autolus initially projected sales of $120 million to $135 million for the year.
Margins improve as manufacturing volume rises
Autolus reported a third-quarter gross margin of 57%, up from 55% in the second quarter and a negative margin a year earlier. Gross margin for the first nine months was 44%.
Chief Financial Officer Rob Dolski attributed the year-over-year improvement primarily to lower manufacturing costs per batch, higher production volumes, operational efficiencies, and lower inventory reserves and write-offs. Cost of sales fell to $17.9 million from $28.6 million.
Itin said the company expects to manufacture more than twice as many products in 2026 as in 2025, with fewer staff. He said Autolus expects continued manufacturing efficiency gains rather than further immediate step changes, and anticipates approaching the upper end of its indicated 65% to 70% gross margin range in 2028.
Research and development expenses rose to $30.9 million from $27.9 million, primarily because of higher clinical manufacturing supply costs. Selling, general and administrative expenses were $35.9 million, compared with $36.3 million a year earlier. The net loss narrowed to $55.1 million from $79.1 million, while the operating loss fell to $43.5 million from $71.6 million.
Cash, cash equivalents and marketable securities totaled $248.4 million at Sept. 30, up from $201.6 million at the end of June. Dolski said the increase primarily reflected financing from a credit facility with Perceptive Advisors, including an initial $75 million tranche. The company expects its resources to fund operations into the second quarter of 2028, assuming anticipated sales and proceeds from a second $25 million tranche.
Center expansion and sales outlook
Autolus has authorized 90 treatment centers in the U.S. and 18 in the U.K. It had set a goal of activating 80 U.S. centers during 2026 and reached that number in the third quarter.
Itin said approximately 80 U.S. centers provide access to about 80% of patients. Further expansion will target gaps in patient access, follow physicians establishing CAR T therapy at new centers and include selected non-academic centers with substantial patient flows, he said.
Asked about the fourth-quarter sales outlook, Itin said the company had seen similar sales levels across the second, third and fourth quarters of 2025. He also said the holiday period can slow dosing, particularly between Christmas and New Year’s, although the impact was limited last year.
The CEO said upcoming real-world AUCATZYL data from the ROCCA consortium could support adoption. He added that sales growth in a product’s third and fourth years typically is smaller than the increase between its first and second years.
Autolus defers MS data presentation for longer follow-up
Autolus plans to present initial data from its BOBCAT study in progressive multiple sclerosis at ECTRIMS in October 2027 rather than at the March meeting. Itin said clinical experts advised that at least 12 months of follow-up is needed to begin interpreting disability scores, with 24 months preferable.
By the October meeting, the company expects to have 12 patients with at least 12 months of follow-up and another 12 with six to 12 months. Itin said the study remains on track and that the presentation timing does not change the company’s development decision-making process.
The study was expanded from 18 to 24 patients to provide a larger dataset for assessing clinical impact, including across two preconditioning regimens, Itin said. He described bendamustine as potentially causing less hematological toxicity than fludarabine and cyclophosphamide, though he noted it is known to be less effective as a preconditioning agent in leukemia and lymphoma.
Upcoming clinical data
Autolus said longer-term follow-up from its phase 1 CARLYSLE study in severe refractory systemic lupus erythematosus showed sustained clinical responses and a safety profile with up to 25 months of follow-up. The data were scheduled for presentation at the ACR meeting on the day of the call.
Itin said the company had not seen a visible impact on enrollment from safety-related news in the autoimmune cell therapy field during the second half of the year. The LUMINA study in refractory lupus nephritis continues to enroll, while the CATULUS study in pediatric acute lymphoblastic leukemia is expected to complete enrollment around the end of 2026 or early 2027.
At the upcoming ASH meeting, Autolus expects additional AUCATZYL data in adult relapsed or refractory acute lymphoblastic leukemia and initial AUTO8 data in light-chain amyloidosis. Itin said the AUTO8 presentation will include early patients treated with both BCMA- and CD19-targeting components, as well as longer follow-up on patients who received the BCMA component.
About Autolus Therapeutics (NASDAQ:AUTL)
Autolus Therapeutics plc is a biopharmaceutical company focused on developing and commercializing programmed T-cell therapies for cancer. The company’s approach is designed to engineer T cells to recognize and eliminate malignant cells while incorporating features intended to improve activity, persistence and safety.
Its lead product, obecabtagene autoleucel, is an autologous CAR T-cell therapy marketed in the United States under the brand name Aucatzyl. It is used to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
