Autolus Therapeutics plc
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001730463-25-000067
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001730463-25-000088
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 195 previous paragraphs and 199 current paragraphs.
128 unchanged; 53 reworded; 18 added; 13 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (18)
Current report
•We reported net product revenue, net of $21.1 milion for three months ended September 30, 2025 and deferred revenue of $7.6 milion as of September 30, 2025.
Current report
•We have 60 cancer treatment centers fully activated in the United States of November 12, 2025, achieving the target of 60 activated centers prior to year-end.
Current report
•The United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”) granted AUCATZYL conditional marketing authorization in April 2025, and Autolus has since engaged with the National Institute for Health and Care Excellence (“NICE”) to obtain its recommendation for reimbursement of AUCATZYL by the National Health Service (“NHS”). Such discussions are ongoing and Autolus anticipates commercial launch in the United Kingdom, provided these discussions result in an appropriate level of reimbursement for AUCATZYL for an appropriate patient population.
Current report
•Data from the Real-World Outcomes Collaborative for CAR T in Adult ALL database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL (obecabtagene autoleucel) and TECARTUS (brexucabtagene autoleucel) for relapsed acute lymphoblastic leukemia with r/r ALL will be presented at the American Society of Hematology Annual Meeting.
Current report
•Data from the ongoing Phase Ib/II CATULUS study evaluating the safety and efficacy of obe-cel in patients under 18 years with CD19-positive r/r B-ALL or B-cell Non-Hodgkin Lymphoma (“NHL”) will be presented at the American Society of Hematology Annual Meeting (“ASH”). Data show the safety profile of obe-cel in pediatric patients is consistent with that previously reported in adults, with low rates of high-grade cytokine release syndrome (“CRS”) and immune effector cell-associated neurotoxicity syndrome (“ICANS”). Overall response rate (“ORR”) was high at 95% and nearly 90% of responders had ongoing remission at data cut-off. Additional data will be presented in a poster presentation at ASH on December 7, 2025.
Current report
•In October 2025, the FDA granted regenerative medicine advanced therapy (“RMAT”) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL. The RMAT designation is a program created under the 21st Century Cures Act to accelerate development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.
Current report
•We presented data from the Phase 1 CARLYSLE clinical trial on October 28, 2025 at the American College of Rheumatology (“ACR”) Convergence 2025. Data in severe refractory systemic lupus erythematosus (“srSLE”)) suggests obe-cel is well tolerated with no ICANS or high-grade CRS. Preliminary efficacy data demonstrate achievement of definition of remission in SLE (“DORIS”) in 83% (n=5/6) of patients and complete renal response in 50% (n=3/6) of patients. All responses and remissions are ongoing with no evidence of disease activity at a median follow up of 8.9 months (range 6-13.8 months).
Current report
•Additional findings from the ongoing CARLYSLE study will be presented in an oral presentation at the American Society of Hematology Annual Meeting 2025 in December 2025. The B-cell reconstitution profiles data suggest that obe-cel may induce a reset of pathologic autoimmunity. Updated Phase I data with longer follow-up, and data in patients who received 100×106 CAR T-cells will be presented.
Current report
•We have previously aligned with the FDA on the Phase 2 trial design and potential registrational path to approval for obe-cel in LN. Data to date supported progressing into the Phase 2 LUMINA trial. The first patient is expected to be dosed prior to December 31, 2025.
Current report
•We plan to advance obe-cel into initial clinical development in progressive multiple sclerosis (“MS”). The first patient in the Phase 1 BOBCAT trial was dosed in October 2025. The BOBCAT trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. The primary endpoint is to assess safety and tolerability of obe-cel. Key secondary endpoints include evaluating the preliminary efficacy of obe-cel using change from baseline in standard efficacy measures.
Current report
•In November 2025, Moderna announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, an investigational mRNA-based T-cell engager for participants with relapsed or refractory multiple myeloma. mRNA-2808 utilizes Autolus’ proprietary binder that was licensed to Moderna in 2022.
Current report
Research and development expenses, net decreased by $12.4 million to $27.9 million for the three months ended September 30, 2025 from $40.3 million for the three months ended September 30, 2024 primarily due to:
Current report
Selling, general and administrative expenses increased by $9.0 million to $36.3 million for the three months ended September 30, 2025 from $27.3 million for the three months ended September 30, 2024 primarily due to:
Current report
Foreign Exchange Losses, Net
Current report
Interest expense, net decreased to $10.5 million for the three months ended September 30, 2025 as compared to $10.7 million for the three months ended September 30, 2024. Interest expense, net decreased by $0.2 million primarily due to lower other interest expenses offset by higher liabilities related to future royalties and milestone, net balances as of September 30, 2025 compared to September 30, 2024 in relation to the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement.
Current report
Comparison of Nine Months Ended September 30, 2025 and 2024
Current report
Research and development expenses, net decreased by $25.5 million to $82.1 million for the nine months ended September 30, 2025 from $107.6 million for the nine months ended September 30, 2024 primarily due to:
Current report
Selling, general and administrative expenses increased by $28.7 million to $96.1 million for the nine months ended September 30, 2025 from $67.4 million for the nine months ended September 30, 2024 primarily due to:
Removed paragraphs (13)
Previous report
•We reported Q2 2025 net product sales of $20.9 million.
Previous report
•On April 25, 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) granted conditional marketing authorization for AUCATZYL for the treatment of adult patients age 18+ with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“r/r B-ALL”). Following an initial review and in line with prior practice for CAR-T therapies, the National Institute for Health and Care Excellence (“NICE”) issued a preliminary Appraisal Consultation Decision (“ACD”) recommending against funding for AUCATZYL. We plan to respond to NICE’s questions and will continue to work towards a pathway for patient access to therapy in the United Kingdom.
Previous report
•We presented updated long-term data from the FELIX study in adult patients with r/r B-ALL in an oral presentation at the 2025 European Hematology Association (“EHA”) Congress in June. For patients with a response, the updated median duration of response is now 42.5 months. At the updated median follow up of 32.8 months, 38.4% of responders were in ongoing remission without consolidative stem cell therapy or other therapies (versus the previously reported 40% at a median follow-up of 21.5 months). The 24-month probability of Event Free Survival was 43%, and the Overall Survival was 46%, with a further consolidating long-term plateau observed. No new safety signals or Grade ≥3 secondary malignancies were observed at the extended follow-up. These results suggest that obe-cel may be a durable treatment option for some patients with r/r B-ALL.
Previous report
•Preliminary data from the Phase 1 dose confirmation clinical trial (“CARLYSLE”) in refractory systemic lupus erythematosus (“SLE”) patients were reported on April 23, 2025, and support progressing into a planned Phase 2 pivotal study.
Previous report
•The Company has aligned with the U.S. Food and Drug Administration (the “FDA”) on the Phase 2 trial design and potential registrational path to approval and continues to anticipate dosing the first patient in a Phase 2 clinical trial before the end of 2025.
Previous report
•Data with longer term follow-up from the Phase 1 CARLYSLE clinical trial is targeted for presentation at a medical conference in the second half of 2025.
Previous report
•We plan to advance obe-cel into clinical development in progressive MS. We continue to expect to dose our first patient in a Phase 1 dose escalation clinical trial by year-end 2025.
Previous report
Research and development expenses decreased by $9.2 million to $27.4 million for the three months ended June 30, 2025 from $36.6 million for the three months ended June 30, 2024 primarily due to:
Previous report
Selling, general and administrative expenses increased by $8.4 million to $30.3 million for the three months ended June 30, 2025 from $21.9 million for the three months ended June 30, 2024 primarily due to:
Previous report
Foreign Exchange Gains, Net
Previous report
Comparison of Six Months Ended June 30, 2025 and 2024
Previous report
Research and development expenses decreased by $13.1 million to $54.2 million for the six months ended June 30, 2025 from $67.3 million for the six months ended June 30, 2024 primarily due to:
Previous report
Selling, general and administrative expenses increased by $19.7 million to $59.8 million for the six months ended June 30, 2025 from $40.1 million for the six months ended June 30, 2024 primarily due to:
Reworded paragraphs (53)
Previous wording
We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars, and we prepare our consolidated financial statements in accordance with U.S. GAAP, as issued by the FASB. All references in this Quarterly Report on Form 10-Q to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed consolidated statements of operations and comprehensive loss and unaudited condensed consolidated statements of cash flows for the three months ended June 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3355 and £1.00 to $1.2616, respectively. Our unaudited condensed consolidated statements of operations and comprehensive loss and cash flows for the six months ended June 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2971 and £1.00 to $1.2648, respectively. Our unaudited condensed consolidated balance sheet as of June 30, 2025 and audited consolidated balance sheet as of December 31, 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3713 and £1.00 to $1.2535, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at those or any other exchange rate as of those or any other dates.
Current wording
We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars, and we prepare our consolidated financial statements in accordance with U.S. GAAP, as issued by the FASB. All references in this Quarterly Report on Form 10-Q to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed consolidated statements of operations and comprehensive loss and unaudited condensed consolidated statements of cash flows for the three months ended September 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3482 and £1.00 to $1.3008, respectively. Our unaudited condensed consolidated statements of operations and comprehensive loss and cash flows for the nine months ended September 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3141 and £1.00 to $1.2768, respectively. Our unaudited condensed consolidated balance sheet as of September 30, 2025 and audited consolidated balance sheet as of December 31, 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3441 and £1.00 to $1.2535, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at those or any other exchange rate as of those or any other dates.
Previous wording
Since our inception, we have incurred significant operating losses. For the three months ended June 30, 2025 and 2024, we incurred net losses of $47.9 million and $58.3 million, respectively, and had an accumulated deficit of $1,217.3 million and $1,099.2 million as of June 30, 2025 and December 31, 2024, respectively.
Current wording
Since our inception, we have incurred significant operating losses. For the three months ended September 30, 2025 and 2024, we incurred net losses of $79.1 million and $82.1 million, respectively, and had an accumulated deficit of $1,296.4 million and $1,099.2 million as of September 30, 2025 and December 31, 2024, respectively.
Previous wording
As of June 30, 2025, we had cash and cash equivalents of $123.8 million and marketable securities of $330.5 million. Based on our current clinical development and commercialization plans, we believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this Quarterly Report. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our product candidates, management may need to curtail its development efforts and planned operations.
Current wording
As of September 30, 2025, we had cash and cash equivalents of $86.1 million and marketable securities of $281.3 million. Based on our current clinical development and commercialization plans, we believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this Quarterly Report. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our product candidates, management may need to curtail its development efforts and planned operations.
Previous wording
•We have 46 cancer treatment centers fully activated in the United States as of August 12, 2025. Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total United States medical lives.
Current wording
•Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total United States medical lives.
Previous wording
•On July 17, 2025, the European Commission (“EC”) granted marketing authorization for AUCATZYL in adult patients (age 26 and older) with r/r B-ALL. Evaluation of potential pricing and feasibility of market entry opportunities in certain EU countries is ongoing; however, at this time, launch in Germany is on hold and we do not anticipate any EU sales of AUCATZYL in 2025 and 2026.
Current wording
•In July 2025, the European Commission granted marketing authorization for AUCATZYL in adult patients (age 26 and older) with r/r B-ALL. Evaluation of potential pricing and feasibility of market entry opportunities in certain EU countries is ongoing; however, at this time, launch in Germany is on hold and we do not anticipate any EU sales of AUCATZYL in 2025 and 2026.
Previous wording
Our wholly-owned subsidiary in the United States also participates in programs with government entities, the most significant of which are the US. Department of Defense (the “DoD”) and the US. Department of Veterans Affairs (the “VA”), and other parties, including covered entities under the 340B Drug Pricing Program (the “340B Program”), whereby pricing on products is extended below list price to participating entities. These entities are entitled to purchase AUCATZYL at the lower program price by charging the Company the difference between their acquisition cost and the lower program price. Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale.
Current wording
Our Company's wholly-owned subsidiary in the United States also participates in programs with government entities, the most significant of which are the covered entities under the 340B Drug Pricing Program (the “340B Program”), the US. Department of Defense (the “DoD”), and the US. Department of Veterans Affairs (the “VA”), whereby pricing on products is extended below list price to participating entities. These entities purchase products at the lower program price then charge the Company the difference between their acquisition cost and the lower program price. Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale.
Previous wording
Our wholly-owned subsidiary in the United States further participates in state government Medicaid programs and the Tricare program requiring discounts and rebates to participating government entities. All rebates provided through these programs are included in our Medicaid and Tricare rebate accrual. The estimated amount of unpaid or unbilled rebates are to be recognized and presented as a liability.
Current wording
Our Company's wholly-owned subsidiary in the United States further participates in state government Medicaid programs and the TriCare program. All discounts and rebates provided through these programs are included in the Company's Medicaid and TriCare rebate accrual. The estimated amount of unpaid or unbilled rebates are to be recognized and presented as a liability.
Previous wording
Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch raw materials inventory is depleted. Thus, the cost of sales as a percentage of net sales of AUCATZYL for the three and six months ended June 30, 2025 was affected by use of the initial pre-launch raw materials inventory, which was previously expensed as research and development expense, and is referred to as zero cost inventories. We estimate our cost of sales as a percentage of net product revenue and will continue to be positively impacted as we sell product which includes some raw material inventory that was previously expensed prior to the FDA approval.
Current wording
Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch raw materials inventory is depleted. Thus, the cost of sales as a percentage of net sales of AUCATZYL for the three and nine months ended September 30, 2025 was affected by use of the initial pre-launch raw materials inventory, which was previously expensed as research and development expense, and is referred to as zero cost inventories. We estimate our cost of sales as a percentage of net product revenue and will continue to be positively impacted as we sell product which includes some raw material inventory that was previously expensed prior to the FDA approval.
Previous wording
The SME program has been particularly beneficial to us as under such program the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreasing to 18.6% after April 1, 2023. The United Kingdom government enacted changes to the SME regime effective from April 1, 2023 which included the introduction of a new rate for R&D intensive companies of 27%. Qualifying expenditures largely comprise of employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income. A large proportion of costs relate to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.
Current wording
The SME program has been particularly beneficial to us as under such program the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreased to 18.6% after April 1, 2023. The United Kingdom government enacted changes to the SME regime effective from April 1, 2023 which included the introduction of a new rate for R&D intensive companies of 27%. Qualifying expenditures largely comprise of employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income. A large proportion of costs relate to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.
Previous wording
Amendments to the current SME and RDEC programs contained in the Finance Act 2024 (unless limited exceptions apply) introduce (i) restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such activities are not carried out in the United Kingdom or such workers are not subject to United Kingdom payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies. These changes take effect from periods commencing after April 1, 2024.
Current wording
Amendments to the current SME and RDEC programs contained in the Finance Act 2024 (unless limited exceptions apply) introduce (i) restrictions on the tax relief that can be claimed for expenditure incurred on sub-contracted R&D activities or externally provided workers, where such activities are not carried out in the United Kingdom or such workers are not subject to United Kingdom payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies. These changes apply to periods commencing after April 1, 2024.
Previous wording
Selling, general and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and other administrative functions. Selling, general and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, accounting and audit services. Included in selling, general and administrative expenses is historical irrecoverable input VAT previously claimed on selling, general and administrative expenses and subsequently reversed.
Current wording
Selling, general and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and other administrative functions. Selling, general and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, accounting, termination benefits and related charges and audit services. Included in selling, general and administrative expenses is historical irrecoverable input VAT previously claimed on selling, general and administrative expenses and subsequently reversed.
Previous wording
Un-surrendered United Kingdom losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $545.6 million at December 31, 2024. A valuation allowance has been recognized against our deferred tax asset relating to our United Kingdom losses. We carried a $2.4 million deferred tax asset balance related to the United States entity at June 30, 2025 for which a valuation allowance of $1.8 million was applied. At June 30, 2025, we recorded a full valuation allowance against the net deferred tax asset in the United Kingdom, as the recoverability due to future taxable profits was uncertain.
Current wording
Un-surrendered United Kingdom losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $545.6 million at December 31, 2024. A valuation allowance has been recognized against our deferred tax asset relating to our United Kingdom losses. We carried a $2.4 million deferred tax asset balance related to the United States entity at September 30, 2025 for which a valuation allowance of $1.7 million was applied. At September 30, 2025, we recorded a full valuation allowance against the net deferred tax asset in the United Kingdom, as the recoverability due to future taxable profits was uncertain.
Previous wording
During the three months ended June 30, 2025, we generated product revenue, net in the amount of $20.9 million, from the sales of AUCATZYL in the United States. We did not generate any product revenue in the three months ended June 30, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024.
Current wording
During the three months ended September 30, 2025, we generated product revenue, net in the amount of $21.1 million, from the sales of AUCATZYL in the United States. We did not generate any product revenue in the three months ended September 30, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024.
Previous wording
In the six months ended June 30, 2025, we recognized cost of sales of $42.4 million, primarily consisting of salaries and other employment related costs, including share-based compensation expense, for personnel involved in AUCATZYL manufacturing activities, as well as outsourced professional services. These costs also included direct production costs for commercial product manufacturing and allocated facility costs such as maintenance, depreciation, utilities and lease expenses. We did not recognize any cost of sales in the six months ended June 30, 2024, as AUCATZYL was not approved by the FDA for commercial use until November 8, 2024.
Current wording
In the three months ended September 30, 2025, we recognized cost of sales of $28.6 million, primarily consisting of salaries and other employment related costs, including share-based compensation expense, for personnel involved in AUCATZYL manufacturing activities, as well as outsourced professional services. These costs also included direct production costs for commercial product manufacturing and allocated facility costs such as maintenance, depreciation, utilities and lease expenses. Inventory reserves and write-offs recognized in cost of sales for the three and nine months ended September 30, 2025 amounted to $4.3 million and $7.6 million, respectively, reflecting estimated obsolescence and lower market values. We did not recognize any cost of sales in the three months ended September 30, 2024, as AUCATZYL was not approved by the FDA for commercial use until November 8, 2024.
Previous wording
Certain manufacturing expenses incurred prior to AUCATZYL receiving FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the three months ended June 30, 2025, would have increased by approximately $1.9 million.
Current wording
Certain manufacturing expenses incurred prior to AUCATZYL receiving the FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the three months ended September 30, 2025, would have increased by approximately $2.3 million.
Previous wording
The following tables provide additional detail on our research and development expenses (in thousands):
Current wording
The following tables provide additional detail on our research and development expenses, net (in thousands):
Previous wording
•a decrease of $4.4 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by the reallocation of employees to commercial manufacturing activities included in cost of sales and inventories; offset by:
Current wording
•a decrease of $8.6 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by the reallocation of employees to commercial manufacturing activities included in cost of sales and inventories;
Previous wording
•a decrease of $14.0 million related to our information technology infrastructure and support for information systems related to an allocation of expense from research and development to cost of sales and inventories related to commercial manufacturing following FDA approval of AUCATZYL in November 2024; and
Current wording
•a decrease of $3.9 million related to our information technology infrastructure and support for information systems related to an allocation of expense from research and development to cost of sales and inventories related to commercial manufacturing following the FDA approval of AUCATZYL in November 2024; and
Previous wording
•a decrease of $1.8 million in clinical trial costs, clinical manufacturing costs, material transportation costs and utilization of raw materials and consumables relating to research and development activities; offset by:
Current wording
•a decrease of $2.6 million in clinical trial costs, clinical manufacturing costs, material transportation costs and utilization of raw materials and consumables relating to research and development activities; offset by:
Previous wording
•a decrease of $2.8 million in United Kingdom R&D tax credits (resulting in an increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, as well as lower qualifying spend.
Current wording
•a decrease of $2.7 million in United Kingdom R&D tax credits (resulting in an increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, as well as lower qualifying spend.
Previous wording
•an increase of $5.8 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in selling, general and administrative activities;
Current wording
•an increase of $4.8 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in selling, general and administrative activities;
Previous wording
•an increase of $0.2 million in commercial readiness costs including legal and professional fees due to increased commercial readiness activities being undertaken.
Current wording
•an increase of $2.8 million in commercial costs, including legal and professional fees due to increased activity in support of U.S. and international market access; and
Previous wording
•an increase of $2.4 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations including increase in space utilized for these activities; and
Current wording
•an increase of $1.4 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations including increase in space utilized for these activities.
Previous wording
Foreign exchange gains, net increased to $1.5 million for the three months ended June 30, 2025 as compared to $1.2 million for the three months ended June 30, 2024 primarily due to gains and losses on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, as well as our cash and cash equivalents and liabilities related to future royalties and milestones.
Current wording
Foreign exchange losses, net decreased to $0.9 million for the three months ended September 30, 2025 as compared to $11.9 million for the three months ended September 30, 2024 primarily due to gains and losses on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, as well as our cash and cash equivalents and liabilities related to future royalties and milestones.
Previous wording
Interest income decreased to $5.2 million for the three months ended June 30, 2025, as compared to $9.6 million for the three months ended June 30, 2024. The decrease in interest income of $4.4 million was primarily driven by lower aggregate balances and yield associated with our cash, cash equivalents and marketable securities during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024.
Current wording
Interest income decreased to $4.4 million for the three months ended September 30, 2025, as compared to $8.3 million for the three months ended September 30, 2024. The decrease in interest income of $3.9 million was primarily driven by lower aggregate balances and yield associated with our cash, cash equivalents and marketable securities during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024.
Previous wording
Income tax expense increased to $0.4 million for the three months ended June 30, 2025 as compared to less than $0.1 million for the three months ended June 30, 2024. Income tax expenses increased by $0.3 million primarily due to an increase in Autolus Inc.'s taxable income due to the recognition of product revenue, net and related intra-group recharges during the three months ended June 30, 2025 compared to the three months ended June 30, 2024.
Current wording
Income tax expense increased to $0.5 million for the three months ended September 30, 2025 as compared to less than $0.1 million for the three months ended September 30, 2024. Income tax expenses increased by $0.5 million primarily due to an increase in Autolus Inc.'s taxable income due to the recognition of product revenue, net and related intra-group recharges during the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025, and 2024 (in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025, and 2024 (in thousands):
Previous wording
During the six months ended June 30, 2025, we generated product revenue, net amounting to $29.9 million, from the sale of AUCATZYL in the United States. We did not generate any product revenue in the six months ended June 30, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024.
Current wording
During the nine months ended September 30, 2025, we generated product revenue, net amounting to $51.0 million, from the sale of AUCATZYL in the United States. We did not generate any product revenue in the nine months ended September 30, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024.
Previous wording
There was no license revenue recognized for the six months ended June 30, 2025. License revenue amounting to $10.1 million for the six months ended June 30, 2024 was related to license revenue recognized pursuant to the License and Option Agreement with BioNTech.
Current wording
License revenue amounting to $10.1 million for the nine months ended September 30, 2024 was related to license revenue recognized pursuant to the License and Option Agreement with BioNTech.
Previous wording
In the three months ended June 30, 2025, we recognized cost of sales of $24.4 million, primarily consisting of salaries and other employment related costs, including share-based compensation expense, for personnel involved in AUCATZYL manufacturing activities, as well as outsourced professional services. These costs also included direct production costs for commercial product manufacturing and allocated facility costs such as maintenance, depreciation, utilities and lease expenses. We did not recognize any cost of sales in the three months ended June 30, 2024, as AUCATZYL was not approved by the FDA for commercial use until November 8, 2024.
Current wording
In the nine months ended September 30, 2025, we recognized cost of sales of $71.0 million, primarily consisting of salaries and other employment related costs, including share-based compensation expense, for personnel involved in AUCATZYL manufacturing activities, as well as outsourced professional services. These costs also included direct production costs for commercial product manufacturing and allocated facility costs such as maintenance, depreciation, utilities and lease expenses. We did not recognize any cost of sales in the nine months ended September 30, 2024, as AUCATZYL was not approved by the FDA for commercial use until November 8, 2024.
Previous wording
Certain manufacturing expenses incurred prior to AUCATZYL receiving the FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the six months ended June 30, 2025, would have increased by approximately $4.3 million.
Current wording
Certain manufacturing expenses incurred prior to AUCATZYL receiving the FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the nine months ended September 30, 2025, would have increased by approximately $6.6 million.
Previous wording
The following tables provide additional detail on our research and development expenses (in thousands):
Current wording
The following tables provide additional detail on our research and development expenses, net (in thousands):
Previous wording
•a decrease of $7.8 million related to our information technology infrastructure and support for information systems related to an allocation of expense from research and development to cost of sales and inventories related to commercial manufacturing following the FDA approval of AUCATZYL in November 2024;
Current wording
•a decrease of $17.9 million related to our information technology infrastructure and support for information systems related to an allocation of expense from research and development to cost of sales and inventories related to commercial manufacturing following the FDA approval of AUCATZYL in November 2024;
Previous wording
•a decrease of $2.4 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by the reallocation of employees to commercial manufacturing activities included in cost of sales and inventories; and
Current wording
•a decrease of $13.0 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by the reallocation of employees to commercial manufacturing activities included in cost of sales and inventories; and
Previous wording
•an increase of $1.4 million in clinical trial costs, clinical manufacturing costs, material transportation costs and utilization of raw materials and consumables relating to research and development activities.
Current wording
•a decrease of $1.2 million in clinical trial costs, clinical manufacturing costs, material transportation costs and utilization of raw materials and consumables relating to research and development activities; offset by:
Previous wording
•a decrease of $3.9 million in United Kingdom R&D tax credits (increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, and lower qualifying spend; and
Current wording
•a decrease of $6.6 million in United Kingdom R&D tax credits (increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, and lower qualifying spend.
Previous wording
•an increase of $13.8 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in selling, general and administrative activities;
Current wording
•an increase of $18.5 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in selling, general and administrative activities;
Previous wording
•an increase of $1.8 million in commercial readiness costs including legal and professional fees and marketing costs due to increased commercial readiness activities being undertaken.
Current wording
•an increase of $4.8 million in commercial costs including legal and professional fees and marketing costs associated with market access activities; and
Previous wording
•an increase of $4.1 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations including increase in space utilized for these activities; and
Current wording
•an increase of $5.4 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations including increase in space utilized for these activities.
Previous wording
Foreign exchange gains (losses), net increased to a gain of $2.7 million for the six months ended June 30, 2025 from a loss of $0.5 million for the six months ended June 30, 2024. The gains and losses rises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents and liabilities related to future royalties and milestones.
Current wording
Foreign exchange gains (losses), net increased to a gain of $1.8 million for the nine months ended September 30, 2025 from a loss of $12.4 million for the nine months ended September 30, 2024. The gains and losses rises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents and liabilities related to future royalties and milestones.
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Previous report — wording carried elsewhere
Interest expense, net decreased to negative $6.8 million for the three months ended June 30, 2025 as compared to $10.2 million for the three months ended June 30, 2024. Interest expense, net decreased by $17.0 million primarily due to changes in the assumptions used in the valuation of the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. Changes in the assumptions used in the valuation of the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement resulted in a negative cumulative catch-up adjustment which exceeded the interest expense accrued relating to Blackstone Collaboration Agreement (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest (“BioNTech Liability”) during the three months ended June 30, 2025 compared to the same period in 2024.