On August 12, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported its operational and financial results for the second quarter ended June 30, 2025 (Press release, Autolus, AUG 12, 2025, View Source [SID1234655147]).
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"We are encouraged by AUCATZYL’s early launch performance in the U.S., driven by physician enthusiasm for the product profile, unmet need for r/r B-All patients and favorable market access and reimbursement – supported by strong execution on manufacturing and product delivery," said Dr. Christian Itin, Chief Executive Officer of Autolus. "With recent approvals in the EU and UK our focus shifts to market access on a country-by-country basis. In addition to commercial progress in the adult setting, we look forward to reporting clinical data from the pediatric PY1 trial of obe-cel in ALL in the second half of the year and believe there is additional growth opportunity in pediatric ALL."
"Beyond ALL, we believe obe-cel has ‘pipeline-in-a-product’ potential and could deliver improved outcomes in autoimmune disease. We are excited about the recently reported preliminary data from the Phase 1 CARLYSLE study in systemic lupus erythematous (SLE). We look forward to reporting additional Phase 1 data in SLE patients at a medical conference later this year; dosing the first patient in our planned Phase 2 pivotal trial in LN and starting a Phase 1 trial in progressive multiple sclerosis (MS) by year-end."
Key updates and anticipated milestones:
AUCATZYL Launch
Autolus reported Q2 2025 net product sales of $20.9 million.
The Company has 46 centers fully activated in the U.S. as of August 12, 2025.
Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total U.S. medical lives.
On April 25, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for AUCATZYL for the treatment of adult patients age 18+ with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). Following an initial review and in line with prior practice for CAR T therapies the National Institute for Health and Care Excellence (NICE) issued a preliminary Appraisal Consultation Decision (ACD) recommending against funding for AUCATZYL. Autolus plans to respond to NICE’s questions and will continue to work towards a pathway for patient access to therapy in the UK.
On July 17, 2025, the European Commission (EC) granted conditional marketing authorization for AUCATZYL in adult patients (age 26 and older) with r/r B-ALL. Evaluation of potential pricing and feasibility of market entry opportunities in certain EU countries is ongoing; however, at this time launch in Germany is on hold and the Company does not anticipate any EU sales of AUCATZYL in 2025 and 2026.
Obe-cel data in r/r B-ALL
Autolus presented updated long-term data from the FELIX study in adult patients with r/r B-ALL in an oral presentation at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June. For patients with a response, the updated median duration of response (mDOR) is now 42.5 months. At the updated median follow up of 32.8 months, 38.4% of responders were in ongoing remission without consolidative stem cell therapy or other therapies (versus the previously reported 40% at a median follow-up of 21.5 months). The 24-month probability of Event Free Survival was 43%, and the Overall Survival was 46%, with a further consolidating long-term plateau observed. No new safety signals or Grade ≥3 secondary malignancies were observed at the extended follow-up. These results suggest that obe-cel may be a durable treatment option for some patients with r/r B-ALL.
Obe-cel in lupus nephritis (LN)
Preliminary data from the Phase 1 dose confirmation clinical trial (CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients were reported on April 23, 2025, and support progressing into a planned Phase 2 pivotal study.
The Company has aligned with the U.S. Food and Drug Administration (FDA) on the Phase 2 trial design and potential registrational path to approval and continues to anticipate dosing the first patient in a Phase 2 clinical trial before the end of 2025.
Data with longer term follow-up from the Phase 1 CARLYSLE clinical trial is on track for presentation at a medical conference in the second half of 2025.
Obe-cel in progressive MS
Autolus plans to advance obe-cel into initial clinical development in progressive MS. The Company continues to expect to dose its first patient in a Phase 1 dose escalation study by year-end 2025.
Early-stage pipeline programs and collaborations support longer-term growth
Autolus’ translational programs with UCL continue to fuel its early-stage pipeline, providing a cost-efficient path to development.
Summary of Anticipated News Flow:
ALL: PY01 trial in pediatric ALL first clinical data H2 2025
SLE: Phase 1 CARLYSLE trial presentation at medical conference H2 2025
LN: Expect to dose first patient in Phase 2 trial By year-end 2025
MS: Expect to dose first patient in Phase 1 trial in progressive MS By year-end 2025
ALA: Expect to dose first patient in Phase 1 trial in AL amyloidosis By year-end 2025
ALL: adult lymphoblastic leukemia
SLE: systemic lupus erythematosus
LN: lupus nephritis
MS: multiple sclerosis
ALA: light-chain amyloidosis
Financial Results for the Quarter Ended June 30, 2025
Product revenue, net for the three months ended June 30, 2025 was $20.9 million.
Cost of sales for the three months ended June 30, 2025 totaled $24.4 million. This amount includes the cost of all commercial product delivered to the authorized treatment centers, including product delivered but not yet recorded as product revenue which is captured as deferred revenue. Additionally, cost of sales includes any cancelled orders in the period, patient access program product, and 3rd party royalties for certain technology licenses.
Research and development expenses decreased from $36.6 million to $27.4 million for the three months ended June 30, 2025, compared to the same period in 2024. This change was primarily due to commercial manufacturing-related employee and infrastructure costs shifting to cost of sales and inventory.
Selling, general and administrative expenses increased from $21.9 million to $30.3 million for the three months ended June 30, 2025, compared to the same period in 2024. This increase was primarily due to salaries and other employment-related costs, driven by increased headcount supporting commercialization activities.
Loss from operations for the three months ended June 30, 2025 was $61.2 million, as compared to $58.9 million for the same period in 2024.
Net loss was $47.9 million for the three months ended June 30, 2025, compared to $58.3 million for the same period in 2024. Basic and diluted net loss per ordinary share for the three months ended June 30, 2025, totaled $(0.18), compared to basic and diluted net loss per ordinary share of $(0.22) for the same period in 2024.
Cash, cash equivalents and marketable securities at June 30, 2025, totalled $454.3 million, as compared to $588.0 million at December 31, 2024. The decrease was primarily driven by net cash used in operating activities and impacted by a delayed cash receipt of approximately $21.7 million in R&D tax credit expected from the UK HMRC, which was expected to be received during the six months ended June 30, 2025.
Autolus estimates that, with its current cash and cash equivalents and marketable securities, the Company is well capitalized to drive the launch and commercialization of obe-cel in r/r B-ALL and to obtain data in the LN pivotal trial and MS Phase 1 trial.
Financial Results for the Period Ended June 30, 2025
Selected Consolidated Balance Sheet Data
(In thousands)
June 30, December 31,
2025 2024
Assets
Cash and cash equivalents $ 123,825 $ 227,380
Marketable securities – Available-for-sale debt securities $ 330,454 $ 360,643
Total current assets $ 574,250 $ 660,929
Total assets $ 720,981 $ 782,725
Liabilities and shareholders’ equity
Deferred revenue $ 2,100 $ —
Total current liabilities $ 68,151 $ 60,743
Total liabilities $ 374,517 $ 355,400
Total shareholders’ equity $ 346,464 $ 427,325
Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Product revenue, net $ 20,923 $ — $ 29,905 $ —
License revenue — — — 10,091
Operating expenses:
Cost of sales (24,445 ) — (42,396 ) —
Research and development expenses, net (27,430 ) (36,612 ) (54,164 ) (67,283 )
Selling, general and administrative expenses (30,265 ) (21,903 ) (59,799 ) (40,080 )
Loss on disposal of property and equipment — — (3 ) —
Impairment of operating lease right-of-use assets and related property and equipment — (414 ) — (414 )
Loss from operations (61,217 ) (58,929 ) (126,457 ) (97,686 )
Foreign exchange gains (losses), net 1,634 1,226 2,942 (379 )
Interest income (expenses), net 12,063 (518 ) 8,057 (12,854 )
Total other income (expenses), net 13,697 708 10,999 (13,233 )
Net loss before income tax (47,520 ) (58,221 ) (115,458 ) (110,919 )
Income tax expense (397 ) (51 ) (2,623 ) (43 )
Net loss attributable to ordinary shareholders (47,917 ) (58,272 ) (118,081 ) (110,962 )
Other comprehensive income, net of tax 18,968 1,026 30,036 1,084
Total comprehensive loss $ (28,949 ) $ (57,246 ) $ (88,045 ) $ (109,878 )
Basic and diluted net loss per ordinary share $ (0.18 ) $ (0.22 ) $ (0.44 ) $ (0.43 )
Weighted-average basic and diluted ordinary shares 266,141,411 265,025,783 266,134,021 255,131,873
Conference Call
Management will host a conference call and webcast today at 8:30am EDT/13:30pm 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