On November 10, 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 third quarter ended September 30, 2026.

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"We delivered another strong quarter of AUCATZYL revenue, primarily driven by growth within existing authorized treatment centers as physicians gain positive experience with the therapy, and supported by real-world data reported through the ROCCA consortium. Importantly, we also continue to improve the gross margin, with strong execution on manufacturing efficiency initiatives," said Dr. Christian Itin, Chief Executive Officer of Autolus.

Dr. Itin added, "AUCATZYL’s performance in adult r/r B-ALL is a key near-term value driver. Longer term, we believe expanding obe-cel across all stages of ALL and into autoimmune indications offers meaningful opportunities for scalable growth, leveraging its favorable profile and Autolus’ proven manufacturing and commercial capabilities. We look forward to autoimmune program data presentations at upcoming key medical meetings."

Product and Pipeline Updates:

AUCATZYL
Autolus reported net product revenue of $41.2 million for the three months ended September 30, 2026, compared to $21.1 million for the same period the prior year. Net revenues were primarily driven by increasing product demand both within existing treatment centers and expansion into new centers, supplemented by contribution from UK sales.
Obe-cel in pediatric r/r B-ALL
The Phase 2 portion of the ongoing CATULUS trial of obe-cel in pediatric patients with relapsed or refractory B-cell precursor ALL (r/r B-ALL) is on track and data are expected to be reported at the end of 2027.
Obe-cel in lupus
Updated data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) will be presented in a poster at the American College of Rheumatology (ACR) Annual Meeting, today, November 10, 2026. These data will include safety and efficacy results with up to 25 months follow-up in adult patients and ≥3 months follow-up in adolescent patients.
LUMINA, the pivotal Phase 2 study of obe-cel in patients with refractory lupus nephritis (LN) continues enrolling in five countries and the Company expects to report data in 2028.
On September 9, 2026, the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation to obe-cel for the treatment of SLE and LN. RMAT is designed to accelerate the development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.
Obe-cel in progressive multiple sclerosis
KOL feedback at the ACTRIMS/ECTRIMS meeting in late October emphasized that initial clinical activity and biomarker data seen across CAR T programs are encouraging but will require longer follow up to judge the clinical benefit in progressive MS patients. Considering this feedback, Autolus plans to move the first data presentation to the ECTRIMS Global meeting in October 2027. At that time, the Company expects to have 12 months or more follow-up for the initial 12 patients dosed, and data in up to 24 patients total. Lymphodepletion with both FLu/Cy as well as bendamustine is being evaluated.

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 ASH (Free ASH Whitepaper) in December 2026.

Outlook:
Autolus now expects full-year 2026 AUCATZYL net product revenue to be at or exceeding the upper end of $150 million from the prior guidance.

Based on current operating plans, including anticipated AUCATZYL net revenues and proceeds of the combined first and second tranches totaling $100 million from the Perceptive credit facility, Autolus expects that its current and projected cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations into Q2 2028.

Summary of Anticipated News Flow:

Longer-term follow up data from CARLYSLE trial in patients with severe refractory systemic lupus erythematosus ACR 2026
November 10, 2026
Initial clinical data from ALARIC Phase 1 trial in patients with light-chain amyloidosis ASH 2026
December 12, 2026
Initial clinical data from BOBCAT Phase 1 trial in patients with progressive MS October 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 September 30, 2026
Product revenue, net increased to $41.2 million for the three months ended September 30, 2026, compared to $21.1 million the same period in 2025.

Cost of sales decreased to $17.9 million for the three months ended September 30, 2026, compared to $28.6 million the same period in 2025. Gross margin1 was 57% in the third quarter of 2026, increasing from 55% in the second quarter of 2026, and a negative gross margin in the same period in 2025. The improvement in gross margin over the prior year was primarily driven by a reduction in manufacturing cost per batch, reflecting increased volumes and the ongoing operational efficiency initiatives, and lower inventory reserves and write-offs compared to the same period in the prior year.

Research and development expenses increased to $30.9 million for the three months ended September 30, 2026, compared to $27.9 million in the same period in 2025. This change was primarily due to an increase in clinical manufacturing supply costs driven by clinical development activities, partially offset by a decrease in salaries and other employment-related costs.

Selling, general and administrative expenses decreased to $35.9 million for the three months ended September 30, 2026, compared to $36.3 million in the same period in 2025. This decrease was primarily due to salaries, other employment-related costs and professional fees supporting commercialization activities in the US and UK.

Loss from operations for the three months ended September 30, 2026, was $43.5 million, as compared to $71.6 million for the same period in 2025.

Net loss was $55.1 million for the three months ended September 30, 2026, compared to $79.1 million for the same period in 2025. Basic and diluted net loss per ordinary share for the three months ended September 30, 2026, was $(0.21), compared to basic and diluted net loss per ordinary share of $(0.30) for the same period in 2025.

Cash, cash equivalents and marketable securities at September 30, 2026, totaled $248.4 million, as compared to $201.6 million at June 30, 2026. The increase was primarily driven by net cash inflows from the senior secured note facility from Perceptive Advisors.

Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)

Three Months Ended
September 30,
Nine Months Ended
September 30,
2026
2025
2026
2025
Revenue:
Product revenue, net $ 41,238 $ 21,144 $ 113,128 $ 51,049
License revenue — 50 17 50
Total revenue, net 41,238 21,194 113,145 51,099
Cost and operating expenses:
Cost of sales (17,927 ) (28,643 ) (62,963 ) (71,039 )
Research and development expenses, net (30,900 ) (27,892 ) (80,008 ) (82,056 )
Selling, general and administrative expenses (35,946 ) (36,280 ) (117,060 ) (96,082 )
Loss from operations (43,535 ) (71,621 ) (146,886 ) (198,078 )
Other (expense) income:
Total other (expenses) income, net (12,045 ) (6,965 ) (18,075 ) 4,037
Net loss before income tax (55,580 ) (78,586 ) (164,961 ) (194,041 )
Income tax benefit (expense) 489 (532 ) (839 ) (3,155 )
Net loss (55,091 ) (79,118 ) (165,800 ) (197,196 )
Other comprehensive income (loss):
Foreign currency exchange translation adjustment 484 (5,868 ) (108 ) 23,790
Unrealized holding (losses) gains on available-for-sale debt securities, net of tax of $0, $0, $0 and $0, respectively (6 ) 86 (159 ) 464
Total other comprehensive income (loss), net of tax 478 (5,782 ) (267 ) 24,254
Total comprehensive loss $(54,613 ) $(84,900 ) $(166,067 ) $(172,942 )

Basic and diluted net loss per ordinary share $ (0.21 ) $ (0.30 ) $ (0.62 ) $ (0.74 )
Weighted-average basic and diluted ordinary shares 266,203,656 266,141,431 266,168,856 266,136,518

Financial Results for the Period Ended September 30, 2026
Selected Consolidated Balance Sheet Data
(In thousands)

September 30, December 31,
2026
2025
Assets
Cash and cash equivalents $ 245,405 $ 104,132
Marketable securities – Available-for-sale debt securities $ 2,972 $ 196,578
Total current assets $ 366,784 $ 435,915
Total assets $ 523,059 $ 589,068
Liabilities and shareholders’ equity
Total current liabilities $ 98,647 $ 73,440
Total liabilities $ 495,663 $ 410,939
Total shareholders’ equity $ 27,396 $ 178,129

Conference Call
Management will host a conference call and webcast today at 8:30am EDT/1:30pm GMT 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, NOV 10, 2026, View Source [SID1234674552])