STOCK TITAN

Autolus expects 2026 AUCATZYL revenue of at least $150M

Autolus expects AUCATZYL revenue at or above the prior guidance’s $150 million upper end and projects funding operations into Q2 2028.

Available on EDGAR Accepted by SEC EDGAR Learn about SEC filing dates
(High)

Sentiment and the balance of points

Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

Form Type
8-K

Rhea-AI Filing Summary

Autolus Therapeutics plc reported third-quarter 2026 AUCATZYL net product revenue of $41.2 million, up 95% year over year from $21.1 million. Gross margin was 57%, compared with 55% in the second quarter of 2026. Net loss was $55.1 million versus $79.1 million a year earlier, while loss from operations was $43.5 million versus $71.6 million. Cash, cash equivalents and marketable securities totaled $248.4 million as of September 30, 2026.

Autolus now expects full-year 2026 AUCATZYL net product revenue to be at or above the prior guidance’s upper end of $150 million. Based on current operating plans, anticipated AUCATZYL revenue and proceeds totaling $100 million from the combined first and second tranches of its Perceptive credit facility, it expects current and projected cash, cash equivalents and marketable securities to fund operations into Q2 2028. Obe-cel studies continue enrolling in lupus nephritis, pediatric ALL and progressive MS; progressive MS data are expected at the ECTRIMS Global meeting in October 2027, and lupus nephritis data in 2028.

2 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 0 points

How the balance works

Positive

  • Moderate pointAUCATZYL net product revenue rose 95% year over year to $41.2 million.
  • Moderate pointQuarterly net loss narrowed to $55.1 million from $79.1 million.

Negative

  • None.

Filing Explained

Autolus says it will present updated Phase 1 CARLYSLE safety and efficacy results at the November 10, 2026 ACR meeting; the update will include up to 25 months of adult follow-up and at least 3 months in adolescents.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
AUCATZYL net product revenue $41.2 million Third quarter 2026; compared with $21.1 million in third quarter 2025
Year-over-year revenue increase 95% AUCATZYL net product revenue in third quarter 2026
Net loss $55.1 million Third quarter 2026; compared with $79.1 million in third quarter 2025
Gross margin 57% Third quarter 2026; compared with 55% in second quarter 2026
Cash, cash equivalents and marketable securities $248.4 million As of September 30, 2026
Full-year AUCATZYL net product revenue outlook At or exceeding the upper end of $150 million Full-year 2026; upper end of prior guidance
Combined first and second credit-facility tranches $100 million Anticipated proceeds from the Perceptive credit facility
Expected funding horizon Into Q2 2028 Based on current operating plans, anticipated AUCATZYL revenue and credit-facility proceeds
gross margin financial
"Gross margin was 57% in the third quarter of 2026"
Gross margin is the difference between how much money a company makes from selling its products and how much it costs to produce them, expressed as a percentage of sales. It shows how efficiently a company is turning sales into profit before other expenses like marketing or salaries. Higher gross margin means the company keeps more money from each sale, which is a good sign of financial health.
Regenerative medicine advanced therapy (RMAT) designation regulatory
"FDA granted regenerative medicine advanced therapy (RMAT) designation to obe-cel"
A Regenerative Medicine Advanced Therapy (RMAT) designation is a U.S. regulatory status given to certain cell, gene, or tissue-based treatments that show promise for serious conditions and early clinical evidence of benefit. It signals that regulators will provide extra guidance and expedited review steps—like giving a promising project a “fast pass” through some development checkpoints—which can shorten time to market and reduce regulatory risk, making the program more valuable and noteworthy to investors.
lymphodepletion medical
"Lymphodepletion with both FLu/Cy as well as bendamustine is being evaluated"
Lymphodepletion is a short medical treatment that lowers a patient’s lymphocytes, the immune cells that can interfere with certain cell-based therapies, to create a more supportive environment for the new therapy to work. Think of it like clearing a crowded garden bed before planting seeds: by temporarily reducing competing cells, the engineered therapy can take hold more effectively. Investors watch lymphodepletion because it affects clinical trial results, safety profiles, treatment adoption, and overall commercial potential.
chimeric antigen receptor (CAR) T cell therapy medical
"CD19 chimeric antigen receptor (CAR) T cell therapy"
relapsed or refractory B-cell precursor ALL medical
"patients with relapsed or refractory B-cell precursor ALL"
Product revenue, net $41.2 million Up 95% year over year from $21.1 million
Net loss $55.1 million Compared with $79.1 million in third quarter 2025
Gross margin 57% Compared with 55% in second quarter 2026
Loss from operations $43.5 million Compared with $71.6 million in third quarter 2025
Guidance

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What was AUTL’s AUCATZYL revenue in Q3 2026?

Autolus reported $41.2 million in net product revenue for the three months ended September 30, 2026, compared with $21.1 million in the same period of 2025, a 95% year-over-year increase.

How long does AUTL expect its cash to fund operations?

Autolus expects its current and projected cash, cash equivalents and marketable securities to fund operations into Q2 2028, based on current operating plans that include anticipated AUCATZYL revenue and proceeds totaling $100 million from the combined first and second tranches of its Perceptive credit facility.

When does AUTL expect to present progressive MS data?

Autolus expects to present progressive MS data at the ECTRIMS Global meeting in October 2027. The company expects at least 12 months of follow-up for the initial 12 patients dosed and data for up to 24 patients total.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
0001730463FALSE00-0000000True00017304632026-11-102026-11-100001730463dei:AdrMember2026-11-102026-11-100001730463autl:OrdinarySharesMember2026-11-102026-11-10

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 10, 2026
Autolus Therapeutics plc
(Exact name of registrant as specified in its Charter)

England and Wales
001-38547
Not applicable
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(I.R.S. Employer Identification No.)
The Mediaworks
191 Wood Lane
LondonW12 7FP
United Kingdom
(Address of principal executive offices)(Zip Code)
(44) 20
3829 6230
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))



Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
American Depositary Shares, each representing one ordinary share, nominal value $0.000042 per share
AUTLThe Nasdaq Global Select Market
Ordinary shares, nominal value $0.000042 per share**
The Nasdaq Stock Market LLC*
*
Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Global Select Market. The American Depositary Shares represent the right to receive ordinary shares and are being registered under the Securities Act of 1933, as amended, pursuant to a separate Registration Statement on Form F-6. Accordingly, the American Depositary Shares are exempt from the operation of Section 12(a) of the Securities Exchange Act of 1934, as amended, pursuant to Rule 12a-8 thereunder.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Conditions.
On November 10, 2026, Autolus Therapeutics plc (the “Company”) announced its financial results for the quarter ended September 30, 2026 and provided a corporate update. A copy of the press release is being furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
The information in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 7.01 Regulation FD Disclosure.
In connection with its conference call on November 10, 2026 to discuss its results for the quarter ended September 30, 2026, the Company will utilize an updated corporate presentation, a copy of which is furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.



Item 9.01 Financial Statements and Exhibits
d) Exhibits
Exhibit No.Description of Exhibit
99.1
Press release dated November 10, 2026
99.2
Corporate Presentation dated November 10, 2026
104
Cover Page Interactive Date File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AUTOLUS THERAPEUTICS PLC
Dated: November 10, 2026By:/s/Christian Itin, Ph.D.
Name: Christian Itin, Ph.D.
Title: Chief Executive Officer



Autolus Therapeutics Reports Third Quarter 2026 Financial Results and Business Updates November 10, 2026 at 7:00 AM EST Company reports AUCATZYL® (obecabtagene autoleucel; obe-cel) net product revenue of $41.2 million, an increase of 95% year-over-year; now expects full-year 2026 AUCATZYL net product revenue to be at or exceeding upper end of $150 million from prior guidance  Gross margin increased to 57%, driven by growing volumes and manufacturing efficiency initiatives Obe-cel clinical development programs progressing with trial enrollment ongoing in lupus nephritis, pediatric ALL and progressive multiple sclerosis (MS) Conference call to be held today at 8:30am EST/1:30pm GMT: conference call participants should pre-register using the link at the bottom of this press release LONDON and GAITHERSBURG, Md., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, today announces its operational and financial results for the third quarter ended September 30, 2026. “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. EX-99.1


 

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 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 https://www.autolus.com/investor-relations- media/events/. About Autolus Therapeutics plc Autolus Therapeutics plc (Nasdaq: AUTL) is a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a marketed therapy, AUCATZYL®, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com. About AUCATZYL® (obecabtagene autoleucel; obe-cel) AUCATZYL is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. AUCATZYL is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. AUCATZYL was approved by the FDA for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia on November 8, 2024, and was granted conditional marketing authorization by MHRA in the UK and EMA in the EU in 2025. INDICATION  AUCATZYL® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).  IMPORTANT SAFETY INFORMATION    WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES     Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.1)].     Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate  


 

access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed [see Dosage and Administration (2.2, 2.3), Warnings and Precautions (5.2)].   T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies [see Warnings and Precautions (5.8)].   WARNINGS AND PRECAUTIONS  Cytokine Release Syndrome (CRS)  Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days following the first infusion (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). The most common manifestations of CRS included fever (100%), hypotension (35%), and hypoxia (19%).  Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). Sixty-eight percent of patients (51/75) experienced CRS after the first infusion, but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 10 days). Among patients with CRS, the most common manifestations of CRS included fever (100%), hypotension (35%) and hypoxia (19%). The primary treatment for CRS was tocilizumab (73%; 55/75), with patients also receiving corticosteroids (21%; 16/75). Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 7 days following each infusion. Continue to monitor patients for CRS for at least 2 weeks following each infusion with AUCATZYL. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.  Neurologic Toxicities Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which were fatal or life-threatening, occurred following treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100) of patients, including Grade ≥ 3 in 12% of patients. The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Fifty-five percent of patients (35/64) experienced neurologic toxicities after the first infusion but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 11 days). Among patients with neurologic toxicities, the most common symptoms (> 5%) included ICANS (38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%), anxiety (9%), insomnia (9%), and delirium (8%).  Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)  ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7% (7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24) experienced an onset after the first infusion, but prior to the second infusion of AUCATZYL. The median time to onset for ICANS events after the first infusion was 8 days (range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second infusion, with a median duration of 8.5 days (range: 1 to 53 days). Eighty-eight percent (21/24) of patients received treatment for ICANS. All treated patients received high-dose corticosteroids and 42% (10/24) of patients received anti-epileptics prophylactically. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage ICANS. During and following AUCATZYL administration, closely monitor patients for signs and symptoms of Neurologic Toxicity/ICANS. Following treatment with AUCATZYL, monitor patients daily for at least 7 days. Continue to monitor patients for at least 2 weeks following treatment with AUCATZYL. Avoid driving for at least 2 weeks after each infusion. Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity/ICANS, immediately evaluate patients for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.  Prolonged Cytopenias Patients may exhibit cytopenias including anemia, neutropenia, and thrombocytopenia for several weeks after treatment with lymphodepleting chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade ≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%, 6/41). Monitor blood counts after AUCATZYL infusion.  Infections Severe, including life-threatening and fatal infections occurred in patients after AUCATZYL infusion. Non-COVID-19 infections of all grades occurred in 67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred in 41% (41/100) of patients. AUCATZYL should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after AUCATZYL infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.  Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients after AUCATZYL infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.  Viral reactivation, potentially severe or life-threatening, can occur in patients treated with drugs directed against B cells. There is no experience with manufacturing AUCATZYL for patients with a positive test for human immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing.  Hypogammaglobulinemia Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL infusion. Hypogammaglobulinemia was reported in 10% (10/100) of patients treated with AUCATZYL including Grade 3 events in 2 patients (2%).  Immunoglobulin levels should be monitored after treatment with AUCATZYL and managed per institutional guidelines including infection precautions, antibiotic or antiviral prophylaxis, and immunoglobulin replacement. 


 

The safety of immunization with live viral vaccines during or following treatment with AUCATZYL has not been studied. Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until immune recovery following treatment with AUCATZYL.  Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) HLH/MAS including fatal and life-threatening reactions occurred after treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41, respectively. One patient experienced a concurrent ICANS events after AUCATZYL infusion and died due to sepsis with ongoing HLH/MAS that had not resolved. Administer treatment for HLH/MAS according to institutional standards.  Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for hypersensitivity reactions during and after AUCATZYL infusion.  Secondary Malignancies  Patients treated with AUCATZYL may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Autolus at 1-855-288-5227 for reporting and to obtain instructions on the collection of patient samples for testing.  Adverse Reactions The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 106 CD19 CAR-positive viable T cells (range: 10 to 480 × 106 CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 106 +/- 25%). The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia. Nine patients (9%) experienced fatal adverse reactions which included infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism, acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients, five patients who died from infections had pre-existing and ongoing neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy treatment and/or AUCATZYL.  Please see full Prescribing Information, including BOXED WARNING and Medication Guide.  Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may," “will,” “could," “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding Autolus’ future expectations, plans and prospects, including guidance on 2026 AUCATZYL net product revenue and gross margin, and the impact of recently announced restructuring activities; Autolus’ anticipated cash runway; the therapeutic potential and expected clinical benefits of AUCATZYL for adult patients with r/r B-ALL and obe-cel in additional indications including LN and progressive MS; Autolus’ ability to generate revenues from AUCATZYL; Autolus’ ability to obtain and maintain regulatory approval for obe-cel for adult r/r B-ALL in additional territories and the timing thereof; expectations regarding the commercialization, marketing and manufacturing of AUCATZYL for adult r/r B-ALL, including expanding into additional territories and the related timing of reaching patients in such territories; the development of obe-cel in autoimmune indications and of additional product candidates, including statements regarding the initiation, timing, progress and the results of clinical studies or trials and related preparatory work; the period during which the results of clinical studies or trials will become available; Autolus’ plans to expand, develop and enhance its manufacturing activities; and Autolus’ pursuit of expanded market access across Europe. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks identified in the section titled “Risk Factors” in Autolus’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC), on March 27, 2026 and any of its subsequent Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Autolus’ subsequent filings with the SEC. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward- looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release. Contact: Amanda Cray  +1 617-967-0207  a.cray@autolus.com  1 Gross margin percentage represents gross margin (net product revenue less cost of sales) divided by net product revenue


 

Q3 2026 Financial Results and Business Updates November 10, 2026 Autolus.com For Investor communication only. Not for use in product promotion. Not for further distribution. EX-99.2


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Disclaimer These slides contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,” “could,” “expects,” “plans,” “anticipates,” and “believes.” These statements include, but are not limited to, statements regarding Autolus’ 2026 AUCATZYL net product revenue and gross margin guidance; anticipated cash runway; commercialization and manufacturing plans for AUCATZYL; expansion into additional markets and indications; and the timing, progress and results of clinical studies of obe-cel and other product candidates. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: Autolus' ability to maintain regulatory approval of AUCATZYL; its ability to execute its commercialization strategy for AUCATZYL; its ability to develop, manufacture and commercialize its other product candidates and the timing or likelihood of expansion of AUCATZYL into additional markets or geographies; Autolus' ability to maintain a commercial infrastructure and to successfully launch, market and sell AUCATZYL; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; the labelling for AUCATZYL/obe-cel in any future indication or patient population, if approved; the potential for payors to delay, limit or deny coverage for AUCATZYL; Autolus' ability to obtain, maintain and enforce intellectual property protection for AUCATZYL or any product candidates it is developing; the results of clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Autolus' Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 27, 2026, as well as discussions of potential risks, uncertainties, and other important factors in Autolus’ subsequent filings with the Securities and Exchange Commission. All information in this presentation is as of the date of the presentation, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this presentation. 2 Developing and Delivering a New Generation of T Cell Therapies


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Agenda 3 • Welcome and Introduction: Amanda Cray, ED, Investor Relations & External Communications • Operational Highlights: Dr. Christian Itin, CEO • Financial Results: Rob Dolski, CFO • Upcoming Milestones and Conclusion: Dr. Christian Itin, CEO • Q&A: Dr. Christian Itin and Rob Dolski Developing and Delivering a New Generation of T Cell Therapies


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Strong AUCATZYL® sales growth in 2026 Developing and Delivering a New Generation of T Cell Therapies 4 +95% vs Q3 2025 +122% vs 9M 2025 90 U.S. Authorized Treatment Centers Q3 2026: $41.2 million 9M 2026: $113.1 million Growing demand in existing U.S. treatment centers as physicians gain positive experience with AUCATZYL New treatment centers coming online expand access in the U.S. Additional ROCCA real-world data expected in December 2026 UK sales supplement growth in U.S. product demand Growth Drivers Global Net Product Revenue WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA ARIZONA UTAH WYOMING COLORADO NEW MEXICO TEXAS NORTH DAKOTA SOUTH DAKOTA NEBRASKA KANSAS OKLAHOMA MINNESOTA IOWA MISSOURI ARKANSAS LOUISIANA WISCONSIN ILLINOIS MISSISSIPPI MICHIGAN OHIO INDIANA KENTUCKY TENNESSEE ALABAMA GEORGIA FLORIDA WEST VIRGINIA VIRGINIA NORTH CAROLINA SOUTH CAROLINA PENN NEW YORK VT NH MAINE MA CT RI NEW YORK Washington Vancouver San Francisco Las Vegas Monterrey Houston Dallas Chicago Miami Toronto Montreal Boston Los Angeles San Diego United States 4 2 2 3 2 2 2 2 2 2 2 2 2 4 2 2 2 2 2 7 3 2


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Executing to the commercial plan in 2026 Developing and Delivering a New Generation of T Cell Therapies 2026 Expectations & Financial Guidance FY 2026 Net Product Revenue Achieved: Positive Gross Margin in 2026 Q3 gross margin of 57% YTD gross margin of 44% Commercial Expansion Achieved: Increase commercial footprint in the US to more than 80 treatment centers 5 WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA ARIZONA UTAH WYOMING COLORADO NEW MEXICO TEXAS NORTH DAKOTA SOUTH DAKOTA NEBRASKA KANSAS OKLAHOMA MINNESOTA IOWA MISSOURI ARKANSAS LOUISIANA WISCONSIN ILLINOIS MISSISSIPPI MICHIGAN OHIO INDIANA KENTUCKY TENNESSEE ALABAMA GEORGIA FLORIDA WEST VIRGINIA VIRGINIA NORTH CAROLINA SOUTH CAROLINA PENN NEW YORK VT NH MAINE MA CT RI NEW YORK Washington Vancouver San Francisco Las Vegas Monterrey Houston Dallas Chicago Miami Toronto Montreal Boston Los Angeles San Diego United States 4 2 2 3 2 2 2 2 2 2 2 2 2 4 2 2 2 2 2 7 3 2 Expect to be at or exceeding upper end of $150 million from prior guidance range Supported by volumes and manufacturing efficiencies


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Path to profitability in the r/r B-ALL business Developing and Delivering a New Generation of T Cell Therapies 6 Optimizing the operating model and driving cost efficiency *Gross margin = (net product revenue less cost of sales) / net product revenue. Increasing volumes and operational efficiency initiatives producing gross margin improvements Peak: expect gross profit margin of 65-70% Optimization: Improve efficiency and increase volumes to drive margins Launch: Establish consistent and high-quality product supply and service We are here Expect continued improvement with volumes and cost efficiencies -9% 6% 55% 57% Q4 2025 Q1 2026 Q2 2026 Q3 2026 Gross Margin %* 44% Year-to-date gross margin


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Upcoming data update: BOBCAT Trial in Progressive MS 7 Progress across the autoimmune portfolio: CARLYSLE trial in SLE to be reported today at ACR Longer-term follow up data show obe-cel activity and long-term durability consistent with expected biology, supporting the broader autoimmune scientific rationale. Q1 2027 Data Plan Update 2H 2027: ECTRIMS Data presentation now 2H 2027 Initial Phase 1 data update will now include: • Patient enrollment moving to plan with last patient expected to be enrolled in Q1 2027 • Consistent KOL feedback at ACTRIMS-ECTRIMS Global Meeting, Oct 2026 in Toronto indicated a need for 12-24 months of follow-up to assess clinical data in PMS • Initial data presentation planned for 2H 2027 • Total of 24 patients, with 12 patients at 12+ months of follow up ‒ Clinical response assessment ‒ Imaging data ‒ Expanded safety, PK/PD & biomarker data ‒ Potential path for next development and regulatory activities Developing and Delivering a New Generation of T Cell Therapies


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line 8 Pipeline-in-a-product: expanding obe-cel's potential beyond adult B-ALL FDA granted RMAT designation for obe-cel in SLE and lupus nephritis on September 9, 2026 Timing Program Update Indication Trial Nov 10, 2026 Obe-cel Longer-term follow up from Phase 1 Systemic Lupus (SLE) CARLYSLE Phase 1 Dec 2026 AUTO8 Initial Phase 1 data AL Amyloidosis ALARIC Phase 1 2H 2027 Obe-cel Phase 1 data Progressive Multiple Sclerosis BOBCAT Phase 1 End of 2027 Obe-cel Phase 2 data Pediatric r/r B-ALL CATULUS Phase 1/2 2028 Obe-cel Phase 2 data Lupus Nephritis (LN) LUMINA Phase 2 Oncology Autoimmune / B Cell Mediated Disease Developing and Delivering a New Generation of T Cell Therapies


 

Financial Results


 

If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Financial summary – key metrics* 10 *Select metrics only; for full financials please refer to the Company’s 10-Q filing Autolus expects that its current and projected cash, cash equivalents and marketable securities, including the combined first and second tranches totaling $100M from the credit facility, will be sufficient to fund the Company’s operations into Q2 2028. Capital base strengthened by the Perceptive credit facility Developing and Delivering a New Generation of T Cell Therapies Cash, cash equivalents & marketable securities $248.4M As of September 30, 2026 USD ($’ 000) Q3 2026 Q3 2025 Variance Product revenue, net 41,238 21,144 20,094 Cost and operating expenses: Cost of sales (17,927) (28,643) 10,716 Research and development expenses, net (30,900) (27,892) (3,008) Selling, general and administrative expenses (35,946) (36,280) 334 Loss from operations (43,535) (71,621) 28,086 Total comprehensive loss (54,613) (84,900) 30,287


 

Conclusion


 

Autolus is positioned for value creation Obe-cel product franchise supports multiple growth opportunities 12 Developing and Delivering a New Generation of T Cell Therapies Initial Indication: Adult r/r B-ALL Strong execution and market expansion 2026 net product revenue at or exceeding $150M, top of prior guidance range Significant opportunity to grow overall CAR T market in adult r/r B-ALL Physician interest to pursue investigator sponsored trials in 1st line ALL 9M 2026 Net Product Revenue Pipeline expansion opportunities grow future commercial potential in new indications Commercial and pipeline opportunities supported by proven manufacturing and product delivery capabilities and established authorized treatment centers • Enrollment ongoing in Phase 2 lupus nephritis and pediatric ALL trials and the Phase 1 progressive MS trial • CARLYSLE at ACR and ALARIC at ASH in 2026, followed by BOBCAT and CATULUS data in 2027 $113.1 million


 

Autolus.com Thank you


 

Filing Exhibits & Attachments

6 documents

Keep reading