On August 11, 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 second quarter ended June 30, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the second quarter we achieved substantial sales growth in the ongoing AUCATZYL launch, driven by physician enthusiasm and expanding product use within existing authorized treatment centers, as well as the addition of new centers coming online. We believe this adoption is testament to the product’s efficacy and differentiated safety profile, which was underscored by the ROCCA consortium real world data reported earlier in the year," said Dr. Christian Itin, Chief Executive Officer of Autolus. "The increased product volumes, combined with the ongoing operational efficiency initiatives announced in April, together drove a significant step up in gross margin. We expect improvement over time towards our peak estimate for adult ALL margins of 65-70%."

Dr. Itin added, "We see adoption of AUCATZYL in adult r/r B-ALL as a key near-term value driver. Longer-term, we believe there are meaningful opportunities to expand into new indications to continue driving scalable growth by leveraging obe-cel’s favorable profile and Autolus’ proven manufacturing and commercial capabilities."

Product and Pipeline Updates:

AUCATZYL Launch
Autolus reported net product revenue of $45.7 million for the three months ended June 30, 2026, compared to $20.9 million for the same period the prior year and compared to $26.2 million for three months ending March 31, 2026. 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 in the second quarter of launch in this market.
Additional data from the FELIX trial focusing on the impact of tumor burden and bridging therapy on safety and efficacy in adult r/r ALL patients treated with obe-cel were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings.
Obe-cel in pediatric r/r B-ALL
The Phase 2 portion of the ongoing CATULUS trial of obe-cel in pediatric relapsed or refractory (r/r) B-cell precursor ALL (B-ALL) patients is on track and data are expected to be reported at the end of 2027.
Obe-cel in lupus
The next data update from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (SLE) has been submitted for presentation at the American College of Rheumatology (ACR) Annual Meeting in the fourth quarter of 2026. 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.
Obe-cel in progressive multiple sclerosis
The Phase 1 BOBCAT trial is expected to include up to 18 adult patients and will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS.
First preliminary results, including safety, PK/PD and biomarker data are planned to be presented at the ACTRIMS Forum in the first quarter of 2027. A larger data set with longer follow up will be reported in the second half of 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.

Q2 2026 Operational Updates:

On August 3, 2026, Autolus announced that the Company entered into a strategic financing with Perceptive Advisors, a leading global healthcare specialist investor, for the sale of notes of up to $250 million in aggregate principal amount in a five-year, interest-only senior credit facility, subject to certain conditions. An initial $75 million principal amount of notes has been issued by Autolus to Perceptive on July 30, 2026, and an additional $25 million in aggregate principal amount will be available at Autolus’ option for up to six months post-closing. An additional $150 million in aggregate principal amount of subsequent capital may become available in separate tranches upon achievement of certain pre-specified revenue milestones.
In June 2026, Autolus was awarded the 2026 Prix Galien UK Award for Best Biotechnology Product. Winners of the prestigious Prix Galien awards are selected by a UK Awards Committee, which comprises 12 experts in the field who are leaders in UK healthcare.
In April 2026, Autolus announced a strategic initiative and plan to improve operational efficiency and reduce operating expenses. As part of this initiative, Autolus implemented 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. The implementation of the workforce reduction plan is now substantially complete.

Outlook:
Autolus recently increased the full year 2026 guidance for AUCATZYL net product revenue to $140 million to $150 million, from between $120 million to $135 million.

Based on current operating plans, including anticipated AUCATZYL net revenues and proceeds of the combined first and second tranches totaling $100 million from the recently-announced 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 By year-end 2026
Initial clinical data from ALARIC Phase 1 trial in patients with light-chain amyloidosis By year-end 2026
Initial clinical data from BOBCAT Phase 1 trial in patients with progressive MS Q1 2027
Phase 1 data from BOBCAT trial in patients with progressive MS 2H 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 June 30, 2026
Product revenue, net increased to $45.7 million for the three months ended June 30, 2026, compared to $20.9 million the same period in 2025.

Cost of sales decreased to $20.5 million for the three months ended June 30, 2026, compared to $24.4 million the same period in 2025. Gross margin1 was 55% in the second quarter of 2026, increasing from 6% in the first quarter of 2026 and negative in all prior quarters in 2025. This improvement in gross margin 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 $27.9 million for the three months ended June 30, 2026, compared to $27.4 million in the same period in 2025. This change was primarily due to an increase in research and development activities including clinical trial and clinical manufacturing supply costs and is partially offset by a decrease in salaries and other employment-related costs.

Selling, general and administrative expenses increased to $41.2 million for the three months ended June 30, 2026, compared to $30.3 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, the quarter also included additional 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 June 30, 2026, was $43.8 million, as compared to $61.2 million for the same period in 2025.

Net loss was $39.1 million for the three months ended June 30, 2026, compared to $47.9 million for the same period in 2025. Basic and diluted net loss per ordinary share for the three months ended June 30, 2026, was $(0.15), compared to basic and diluted net loss per ordinary share of $(0.18) for the same period in 2025.

Cash, cash equivalents and marketable securities at June 30, 2026, totaled $201.6 million, as compared to $229.4 million at March 31, 2026. The decrease was primarily driven by net cash used in operating activities, which includes cash received in relation to a UK R&D tax credit.

Unaudited 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,
2026 2025 2026 2025
Revenue:
Product revenue, net $45,672 $20,923 $71,890 $29,905
License revenue 17 — 17 —
Total revenue, net 45,689 20,923 71,907 29,905
Cost and operating expenses:
Cost of sales (20,468) (24,445) (45,036) (42,396)
Research and development expenses, net (27,898) (27,430) (49,108) (54,164)
Selling, general and administrative expenses (41,161) (30,265) (81,114) (59,802)
Loss from operations (43,838) (61,217) (103,351) (126,457)
Total other income (expenses), net 5,192 13,697 (6,030) 10,999
Net loss before income tax
Income tax expense (465) (397) (1,328) (2,623)
Net loss (39,111) (47,917) (110,709) (118,081)
Other comprehensive (loss) income:
Total other comprehensive income (loss), net of tax 526 18,968 (745) 30,036

Total comprehensive loss $(38,585) $(28,949) $(111,454) $(88,045)

Basic and diluted net loss per ordinary share $(0.15) $(0.18) $(0.42) $(0.44)
Weighted-average basic and diluted ordinary shares 266,158,829 266,141,411 266,151,170 266,134,021

Unaudited Selected Consolidated Balance Sheet Data
(In thousands)

June 30, December 31,
2026 2025
Assets
Cash and cash equivalents $ 171,414 $ 104,132
Marketable securities – Available-for-sale debt securities $ 30,216 $ 196,578
Total current assets $ 336,091 $ 435,915
Total assets $ 493,226 $ 589,068
Liabilities and shareholders’ equity
Total current liabilities $ 68,790 $ 73,440
Total liabilities $ 418,387 $ 410,939
Total shareholders’ equity $ 493,226 $ 589,068

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, AUG 11, 2026, View Source [SID1234669942])