Autolus (Nasdaq: AUTL) grows AUCATZYL sales and cuts costs in Q1 2026
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Autolus Therapeutics reported strong commercial momentum for AUCATZYL in the first quarter of 2026, with net product revenue rising to $26.2 million from $9.0 million a year earlier. This shift supported the company’s first positive gross margin for its acute lymphoblastic leukemia business.
Despite this progress, Autolus remains loss-making, with a Q1 2026 net loss of $71.6 million and basic and diluted net loss per share of $(0.27). The company is executing a cost reduction plan, including a workforce reduction of about 13% and expects annualized operating expense savings of roughly $15 million from 2027, after about $8 million in restructuring charges. Management reaffirmed 2026 AUCATZYL net product revenue guidance of $120–$135 million and expects existing cash, cash equivalents and marketable securities of $229.4 million as of March 31, 2026 to fund operations into Q4 2027.
Positive
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Negative
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Insights
Autolus shows rapid AUCATZYL growth but remains deeply loss-making while restructuring.
Autolus delivered Q1 2026 net product revenue of $26.2 million, almost triple the prior-year quarter’s $9.0 million, driven by AUCATZYL launches in the US and UK. This supported a turn to positive gross margin for the ALL business, a key commercial milestone.
However, the broader P&L remains pressured. Research and development expenses fell to $21.2 million, but selling, general and administrative costs climbed to $39.9 million as commercialization ramped, leaving an operating loss of $59.5 million and net loss of $71.6 million. Cash, cash equivalents and marketable securities declined to $229.4 million from $300.7 million at year-end 2025.
Management is pursuing profitability in the ALL franchise via a workforce reduction of about 13%, expected to cut operating expenses by roughly $15 million annually beginning in 2027, with approximately $8 million in restructuring charges recognized mainly in the first half of 2026. The company reiterates 2026 AUCATZYL net product revenue guidance of $120–$135 million and projects its cash runway extending into Q4 2027, assuming anticipated product revenues.
8-K Event Classification
3 items: 2.02, 7.01, 9.01
3 items
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, and exhibit attachments filed with this report.
Key Figures
Net product revenue Q1 2026: $26.2M
Net product revenue Q1 2025: $9.0M
Net loss Q1 2026: $71.6M
+5 more
8 metrics
Net product revenue Q1 2026
$26.2M
AUCATZYL net product revenue for three months ended March 31, 2026
Net product revenue Q1 2025
$9.0M
Net product revenue for three months ended March 31, 2025
Net loss Q1 2026
$71.6M
Net loss for the three months ended March 31, 2026
Loss per share Q1 2026
$(0.27)/share
Basic and diluted net loss per ordinary share, Q1 2026
Cash and securities
$229.4M
Cash, cash equivalents and marketable securities as of March 31, 2026
R&D expense Q1 2026
$21.2M
Research and development expenses for three months ended March 31, 2026
SG&A expense Q1 2026
$39.9M
Selling, general and administrative expenses for three months ended March 31, 2026
Planned opex savings
$15M/year
Expected annualized operating expense reduction beginning in 2027
Key Terms
gross margin, regenerative medicine advanced therapy (RMAT) designation, lupus nephritis (LN), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), +2 more
6 terms
gross margin financial
"Company achieves positive gross margin for the acute lymphoblastic leukemia (ALL) business"
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
"The US Food and Drug Administration (FDA) has 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.
lupus nephritis (LN) medical
"the pivotal LUMINA Phase 2 trial is enrolling and the Company expects to report data in 2028"
Lupus nephritis (LN) is kidney inflammation that occurs when an autoimmune disease called lupus causes the immune system to attack the kidneys, impairing their ability to filter waste. It matters to investors because LN represents a focused medical need: success or failure in developing diagnostics, drugs or devices, plus regulatory decisions and patient uptake, can directly affect the revenues and stock value of companies working in this space—like demand for repairs after a plumbing problem.
Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) medical
"Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal or life-threatening reactions, occurred in patients"
Immune effector cell-associated neurotoxicity syndrome (ICANS) is a range of brain-related side effects that can occur after treatments that boost or use immune cells (for example some engineered cell therapies). Symptoms can include confusion, trouble speaking, seizures, or decreased consciousness, and severity affects patient safety, treatment guidelines, and regulatory review. Investors care because ICANS can influence a therapy’s approval, labeling, hospital monitoring needs, and overall adoption—similar to how a car recall affects a vehicle’s marketability and ongoing costs.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) medical
"HLH/MAS including fatal and life-threatening reactions occurred after treatment with AUCATZYL"
restructuring charges financial
"the Company expects to incur total restructuring charges of approximately $8 million"
Restructuring charges are costs that a company pays when it changes how it operates, like closing factories or laying off employees. These expenses are often one-time and happen to help the company become more efficient in the long run. They matter because they can affect the company's profits and how investors see its future prospects.
Earnings Snapshot
Net product revenue: $26.2M · Guidance included
Q1 2026
Net product revenue
$26.2M
Net loss
$71.6M
Loss per share
$(0.27)
Guidance
Autolus reiterates full-year 2026 AUCATZYL net product revenue guidance of $120–$135 million and expects its cash, cash equivalents and marketable securities to fund operations into Q4 2027.
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): May 14, 2026
(Exact name of registrant as specified in its Charter)
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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 class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
* | 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 May 14, 2026, Autolus Therapeutics plc (the “Company”) announced its financial results for the quarter ended March 31, 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 May 14, 2026 to discuss its results for the quarter ended March 31, 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 May 14, 2026 | |||||||
99.2 | Corporate Presentation dated May 14, 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: May 14, 2026 | By: | /s/Christian Itin, Ph.D. | ||||||
| Name: Christian Itin, Ph.D. | ||||||||
| Title: Chief Executive Officer | ||||||||
Autolus Therapeutics Reports First Quarter 2026 Financial Results and Business Updates May 14, 2026 at 7:00 AM EDT AUCATZYL® (obecabtagene autoleucel; obe-cel) net product revenue of $26.2 million for the first quarter of 2026, reflecting strong launches in the US and most recently the UK Company achieves positive gross margin for the acute lymphoblastic leukemia (ALL) business Cost reduction initiative to drive gross profit margin improvement and path to profitability for the ALL business underway Obe-cel clinical development programs on track with trial enrollment ongoing in lupus nephritis, pediatric ALL and progressive multiple sclerosis (MS) Conference call to be held today at 8:30am EDT/1:30pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON and GAITHERSBURG, Md., May 14, 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 first quarter ended March 31, 2026. “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 EX-99.1
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 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
Q1 2026 Financial Results and Business Updates May 14, 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’ development and commercialization of its product candidates; Autolus' manufacturing, sales and marketing plans for AUCATZYL, including expectations regarding the commercial launch in the United States and the ability to reach patients in a timely manner; the amount and timing of milestone payments under Autolus' collaboration and license agreements; and future development plans of obe-cel, including the timing or likelihood of expansion into additional markets or geographies and related regulatory approvals. 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 4 AUCATZYL® is gaining traction in US and UK markets AUCATZYL Global Net Product Revenue Q1 2026: $26.2 million Developing and Delivering a New Generation of T Cell Therapies • Penetration into US market deepening with positive physician experience – as highlighted in recently reported ROCCA data & Autolus ALL investor event • Early in UK launch, interest and awareness of AUCATZYL is high 2026 Expectations FY 2026 Net Product Revenue: $120-$135 million Shift to positive gross margin in 2026 based on increasing volumes and improved manufacturing plant operation Increase commercial footprint in the US to more than 80 treatment centers and ongoing launch in the UK
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 ALL business Developing and Delivering a New Generation of T Cell Therapies Optimizing the operating model and driving cost efficiency 5 Cost reduction initiatives aimed at driving gross profit margin improvements Reduction in force affecting approximately 13% of existing overall workforce Doubling manufacturing of products for commercial and clinical trial patients in 2026 Actions expected to reduce operating expenses by approximately $15 million on an annualized basis beginning in 2027 while product revenues are increasing Peak: expect gross profit margin of 65-70% Optimization: Improve efficiency and increase volumes to drive margins Launch: Establish consistent and high- quality product supply and service
If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line 6 Pipeline-in-a-product: expanding obe-cel's potential beyond adult B-ALL Indication Trial Status Pediatric r/r B-ALL CATULUS Phase 1/2 Systemic Lupus (SLE) CARLYSLE Phase 1 Lupus Nephritis (LN) LUMINA Phase 2 Progressive Multiple Sclerosis BOBCAT Phase 1 Oncology Autoimmune • Investigator-sponsored trials in earlier line settings of acute lymphoblastic leukemia (ALL) • Real world experience obe-cel data being generated by ROCCA Consortium in r/r aALL Developing and Delivering a New Generation of T Cell Therapies Phase 2 expansion enrolling; data expected at end of 2027 Aligned with FDA on protocol design to support potential registration Phase 2 enrolling; data expected in 2028 Aligned with FDA on protocol design to support potential registration Supported by external opportunities: Initial data reported; longer-term follow up expected at end of 2026 Phase 1 enrolling; initial data expected at end of 2026; full data in 2027
Financial Results
If the title goes over more than one line move the subtitle text box down by 1.15cm per additional line Financial summary – key metrics* USD ($’ 000) Q1 2026 Q1 2025 Variance Product revenue, net 26,218 8,982 17,236 Cost and operating expenses: Cost of sales (24,568) (17,951) (6,617) Research and development expenses, net (21,210) (26,734) 5,524 Selling, general and administrative expenses (39,953) (29,537) (10,416) Loss from operations (59,513) (65,240) 5,727 Total comprehensive loss (72,869) (59,093) (13,776) 8 *Select metrics only; for full financials please refer to the Company’s 10-Q filing 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. $229.4M** as of March 31, 2026 **Cash, cash equivalents and marketable securities Developing and Delivering a New Generation of T Cell Therapies
Upcoming news flow
Upcoming milestones Anticipated Milestone or Catalyst Anticipated Timing Longer-term follow up data from CARLYSLE trial Year End 2026 Initial clinical data from BOBCAT Phase 1 trial in progressive MS Year End 2026 Initial clinical data from ALARIC Phase 1 trial in AL amyloidosis (UCL collab) Year End 2026 BOBCAT trial Phase 1 full data 2027 CATULUS trial pediatric Phase 2 data Year End 2027 LUMINA trial LN Phase 2 data 2028 Obe-cel Oncology Obe-cel Autoimmune/B cell Mediated Disease 10 Developing and Delivering a New Generation of T Cell Therapies
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FAQ
How did Autolus Therapeutics (AUTL) perform financially in Q1 2026?
Autolus generated $26.2 million in net product revenue in Q1 2026, up from $9.0 million a year earlier. Despite this growth and a positive gross margin in the ALL business, the company reported a $71.6 million net loss and loss per share of $(0.27).
What guidance did Autolus Therapeutics (AUTL) give for 2026 AUCATZYL revenue?
Autolus reiterated full-year 2026 guidance for AUCATZYL net product revenue of $120–$135 million. This compares with $74 million in 2025 AUCATZYL revenue and reflects expected continued uptake following launches in the United States and the United Kingdom.
What cost reduction measures is Autolus Therapeutics (AUTL) implementing?
Autolus is executing a strategic cost reduction initiative, including a workforce reduction of about 13% across the business. These actions are expected to reduce operating expenses by approximately $15 million annually from 2027, with roughly $8 million in restructuring charges mostly in the first half of 2026.
What is Autolus Therapeutics’ (AUTL) cash runway after Q1 2026?
Autolus reported $229.4 million in cash, cash equivalents and marketable securities as of March 31, 2026. Based on current operating plans and anticipated AUCATZYL revenues, management expects these resources to fund operations into Q4 2027, providing several years of financial runway.
How are Autolus Therapeutics’ (AUTL) operating expenses trending?
In Q1 2026, research and development expenses decreased to $21.2 million from $26.7 million, while selling, general and administrative expenses increased to $39.9 million from $29.5 million. The SG&A growth reflects commercialization investments and one-time termination-related costs from the efficiency initiative.
What are the key upcoming clinical milestones for Autolus Therapeutics (AUTL)?
Autolus expects initial data by year-end 2026 from the BOBCAT Phase 1 trial in progressive MS and the ALARIC Phase 1 trial in light-chain amyloidosis. Pediatric CATULUS Phase 2 data are anticipated by year-end 2027, and LUMINA lupus nephritis Phase 2 data in 2028.