On May 14, 2026 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, reported its operational and financial results for the first quarter ended March 31, 2026.
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"In the first quarter, Autolus continued to expand market share for AUCATZYL in the US based on strong physician experience in adult ALL, and supported by reliable, high-quality product delivery. Our UK launch, which began in January, is off to a strong start, and we are expanding our reach in this market as well. We are pleased to report a turn to positive gross margin in the first quarter, and we expect continued improvement as we grow sales and manage costs," said Dr. Christian Itin, Chief Executive Officer of Autolus.
Dr. Itin continued, "Beyond adult ALL, given obe-cel’s established profile, we remain focused on broadening obe-cel’s utility in additional indications. Our Phase 2 pivotal studies, CATULUS in pediatric relapsed or refractory B-cell precursor ALL and LUMINA in severe lupus nephritis patients, and our Phase 1 BOBCAT trial in progressive MS, are underway and progressing well."
Dr. Itin concluded, "With good momentum with AUCATZYL and our pipeline, we continue optimizing our operating model and driving cost efficiency. The recently announced initiative will further enhance our margins, support scalable growth and position Autolus for long-term value creation."
Product and Pipeline Updates:
AUCATZYL Launch
Autolus reported net product revenue of $26.2 million for the three months ended March 31, 2026, compared to $9.0 million for the same period the prior year.
AUCATZYL launched in the UK in January 2026 and is now available under routine commissioning.
Data from the ROCCA (Real-World Outcomes Collaborative for CAR T in Adult ALL) consortium covering commercial patients during the first year of launch of AUCATZYL in the US was presented at the TANDEM meeting in February 2026. This real-world data showed consistency in both safety and efficacy with the pivotal FELIX clinical trial that was the basis for regulatory approvals. The ROCCA consortium registry covered approximately 60% of US commercial patients at a data cutoff of January 2026.
Obe-cel in pediatric r/r B-ALL
The Phase 2 portion of the ongoing CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-cell precursor ALL (B-ALL) patients is underway and Autolus expects to report data at the end of 2027. The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL.
Obe-cel in lupus nephritis
Data from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus supported progression of obe-cel as a treatment for lupus nephritis (LN) and selection of the recommended Phase 2 dose of 50 million cells. Following alignment with the FDA on a potential registrational path to approval, the pivotal LUMINA Phase 2 trial is enrolling and the Company expects to report data in 2028.
Obe-cel in progressive MS
Autolus has advanced obe-cel into initial clinical development to explore treatment in progressive MS. The Phase 1 trial, expected to include up to 18 adult patients, is enrolling and will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. The Company expects to report initial data from the trial at the end of 2026 and full data in 2027.
AUTO8 in Light-Chain Amyloidosis
The Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing and initial data are expected to be reported at the end of 2026.
Operational Updates:
In April 2026, Autolus announced a strategic initiative and plan to improve operational efficiency and reduce operating expenses. As part of this initiative, Autolus is implementing a reduction in force affecting approximately 13% of its existing overall workforce, impacting all areas of the business. The actions are expected to reduce operating expenses by approximately $15 million on an annualized basis beginning in 2027. As a result of the reorganization, which includes employee-related actions taken beginning in the second half of 2025, the Company expects to incur total restructuring charges of approximately $8 million, consisting primarily of employee severance and related costs, the majority of which will be recognized in the first half of 2026. The implementation of the workforce reduction plan is expected to be substantially complete by the third quarter of 2026.
In April 2026, the Company held a virtual investor event entitled: Spotlight on Acute Lymphoblastic Leukemia (ALL) Program. The event included key opinion leaders Dr. Jae Park from Memorial Sloan Kettering Cancer Center; Dr. Lori Muffly from Stanford School of Medicine; Dr. Elias Jabbour from MD Anderson Cancer Center and Dr. Michael Pulsipher from University of Utah Huntsman Cancer Institute. A recording of the event is available in the Investor Relations section of the Company’s website, under "Events".
Outlook:
Autolus reiterates its full year 2026 outlook for AUCATZYL net product revenue of between $120 million to $135 million, up from $74 million in 2025, as well as continued positive gross margin in 2026.
Based on current operating plans, including anticipated AUCATZYL net revenues, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q4 2027.
Summary of Anticipated News Flow:
Longer-term follow up data from CARLYSLE trial in patients with severe refractory systemic lupus erythematosus
By year-end 2026
Initial clinical data from BOBCAT Phase 1 trial in patients with progressive MS By year-end 2026
Initial clinical data from ALARIC Phase 1 trial in patients with light-chain amyloidosis By year-end 2026
Phase 1 full data from BOBCAT trial in patients with progressive MS In 2027
Phase 2 data from CATULUS trial in patients with pediatric r/r B-ALL By year-end 2027
Phase 2 data from LUMINA trial in patients with LN In 2028
Financial Results for the Quarter Ended March 31, 2026
Product revenue, net increased to $26.2 million for the three months ended March 31, 2026, compared to $9.0 million the same period in 2025.
Cost of sales increased to $24.6 million for the three months ended March 31, 2026, compared to $18.0 million the same period in 2025. This increase was primarily due to costs related to increased product sales of AUCATZYL in the three months ended March 31, 2026 including inventory reserves and write offs compared to the same period in the prior year. Gross profit was $1.6 million in the first quarter of 2026, compared to a loss in all prior quarters.
Research and development expenses decreased to $21.2 million for the three months ended March 31, 2026, compared to $26.7 million in the same period in 2025. This change was primarily due to a decrease in research and development activities including clinical trial and clinical manufacturing supply costs.
Selling, general and administrative expenses increased to $39.9 million for the three months ended March 31, 2026, compared to $29.5 million in the same period in 2025. This increase was primarily due to salaries, other employment-related costs and professional fees supporting commercialization activities in the US and UK. In addition, this quarter also included one-time termination-related expenses, relating to the strategic operational efficiency and cost reduction initiative announced in April 2026.
Loss from operations for the three months ended March 31, 2026, was $59.5 million, as compared to $65.2 million for the same period in 2025.
Net loss was $71.6 million for the three months ended March 31, 2026, compared to $70.2 million for the same period in 2025. Basic and diluted net loss per ordinary share for the three months ended March 31, 2026, totaled $(0.27), compared to basic and diluted net loss per ordinary share of $(0.26) for the same period in 2025.
Cash, cash equivalents and marketable securities at March 31, 2026, totaled $229.4 million, as compared to $300.7 million at December 31, 2025. The decrease was primarily driven by net cash used in operating activities.
Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)
Three Months Ended March 31,
2026 2025
Revenue:
Product revenue, net $ 26,218 $ 8,982
Total revenue, net 26,218 8,982
Cost and operating expenses:
Cost of sales (24,568 ) (17,951 )
Research and development expenses, net (21,210 ) (26,734 )
Selling, general and administrative expenses (39,953 ) (29,537 )
Loss from operations (59,513 ) (65,240 )
Total other (expenses) income, net (11,222 ) (2,696 )
Net loss before income tax (70,735 ) (67,936 )
Income tax expense (863 ) (2,225 )
Net loss (71,598 ) (70,161 )
Other comprehensive (loss) income:
Total other comprehensive (loss) income, net of tax (1,271 ) 11,068
Total comprehensive loss $ (72,869 ) $ (59,093 )
Basic and diluted net loss per ordinary share $ (0.27 ) $ (0.26 )
Weighted-average basic and diluted ordinary shares 266,143,425 266,126,548
Financial Results for the Three Months Ended March 31, 2026
Selected Consolidated Balance Sheet Data
(In thousands)
March 31, December 31,
2026 2025
Assets
Cash and cash equivalents $ 130,925 $ 104,132
Marketable securities – Available-for-sale debt securities $ 98,509 $ 196,578
Total current assets $ 368,835 $ 435,915
Total assets $ 527,065 $ 589,068
Liabilities and shareholders’ equity
Total current liabilities $ 63,599 $ 73,440
Total liabilities $ 418,239 $ 410,939
Total shareholders’ equity $ 108,826 $ 178,129
Conference Call
Management will host a conference call and webcast today at 8:30am EDT/1:30pm BST to discuss the company’s financial results. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website at View Source
(Press release, Autolus, MAY 14, 2026, View Source [SID1234665696])