Autolus Therapeutics plc
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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Sep 30, 2025 · Filed Nov 12, 2025
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Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Note 1. Nature of the Business
Autolus Therapeutics plc (with its subsidiaries, collectively, “Autolus” or the “Company”) is an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and attack and kill these cells. The Company believes its programmed T cell therapies have the potential to be best-in- class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients. On November 8, 2024 Autolus was notified by the United States Food and Drug Administration (the “FDA”) that its biologics license application (“BLA”) was approved, allowing for the marketing of AUCATZYL (obecabtagene autoleucel, also known as obe-cel) in the United States for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“r/r B-ALL”). The first sale of AUCATZYL in the United States occurred in January 2025. 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. 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 the Company does not anticipate any EU sales of AUCATZYL in 2025 and 2026,
Autolus is registered in England and Wales. Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom.
The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. The Company’s product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. The Company also expects to incur significant additional costs as it expands its commercialization efforts for AUCATZYL. These efforts will require significant amounts of capital, as well as additional personnel, infrastructure, and compliance capabilities. Even if the Company’s product development efforts for obe-cel and its other product candidates are successful, it is uncertain when, if ever, the Company will become profitable.
The Company is a public limited company incorporated under the laws of England and Wales, and qualifies as a “foreign private issuer,” as such term is defined in Rule 405 under the Securities Act of 1933, as amended (the “Securities Act”), and Rule 3b-4 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and, therefore, is not subject to the same requirements that are imposed upon United States domestic issuers by the Securities and Exchange Commission (the “SEC”). The Company has decided to voluntarily file periodic reports, such as annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K on United States domestic issuer forms, which are more detailed and extensive in certain respects, and which must be filed more promptly than the forms currently required for foreign private issuers. Although the Company has voluntarily chosen to file periodic reports and current reports on United States domestic issuer forms, the Company will maintain its status as a foreign private issuer and is not subject to certain other requirements imposed on United States domestic issuers including its officers, directors, and principal shareholders are not subject to the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated interim financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X, and are presented in US dollars. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.
The condensed consolidated balance sheet at December 31, 2024, has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.
The significant accounting policies used in the preparation of these unaudited condensed consolidated interim financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025 (the “Annual Report”). The information included in these unaudited condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2024, included in the Annual Report.
These condensed consolidated interim financial statements include all adjustments, consisting of normal recurring adjustments, which, in the opinion of management, are necessary to fairly state the Company’s financial position as of September 30, 2025, and the results of its operation for the three-month and nine-month period ended September 30, 2025, and cash flows for the nine-month period ended September 30, 2025. The interim results and cash flows are not necessarily indicative of results and cash flows that may be expected for the year ending December 31, 2025.
Going Concern
The Company has incurred recurring losses since its inception, including net losses of $79.1 million and $82.1 million for the three months ended September 30, 2025 and 2024, respectively, and $197.2 million and $193.1 million for the nine months ended September 30, 2025 and 2024, respectively. The Company had an accumulated deficit of $1,296.4 million and $1,099.2 million as of September 30, 2025 and December 31, 2024, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. The Company expects that its cash and cash equivalents and marketable securities of $86.1 million and $281.3 million, respectively, as of September 30, 2025, will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated interim financial statements and accordingly they have been prepared on a going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company is successful in its current and future commercialization efforts for obe-cel and even if the Company's planned regulatory submissions for its current or future products are approved, additional funding may be needed before the Company is expected to become profitable.
Use of Estimates
The preparation of condensed consolidated interim financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated interim financial statements include, but are not limited to, the accrual for research and development expenses, income taxes, initial fair value of warrants, and present value of liabilities related to future royalties and milestones, net including the related interest expense and cumulative catch-up adjustment, incremental borrowing rates related to the Company’s leased properties, allocation of transaction price using the relative standalone selling price relating to license revenue and the estimated expected rebate and chargeback percentage for revenue deductions related to product revenue, net. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates.
Expected rebate and chargeback percentage for product revenue deductions
Since approval of AUCATZYL in November 2024, Autolus has a short history of actual rebate claims or chargebacks, and such information may have limited predictive value. The Company uses the expected value method to estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales. The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as it develops more product revenue experience, and third-party data, which we assess for reliability and relevance.
The Company is subject to state government Medicaid and TriCare programs in the United States which requires rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with AUCATZYL.
The Company's wholly-owned subsidiary in the United States also participates in programs with government entities, which are 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 AUCATZYL is extended below list price to participating entities, including Authorized Treatment Centers (“ATCs”). 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. Estimating expected rebate and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to ATCs and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates.
The Company forms estimates of the 340B Program, Medicaid, the DoD and the VA chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by ATCs. For Medicaid and TriCare rebates, the Company forms estimates based on information obtained from claims received, historical and estimated payor mix, setting of care, discount rates and other industry data, and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates.
Total accrued product revenue deductions for the nine months ended September 30, 2025 of $4.3 million were related to critical estimates subject to significant estimation uncertainty and judgment, as described above. The Company recorded $2.4 million within accrued expenses and other current liabilities in the unaudited condensed consolidated balance sheet related to these deductions as of September 30, 2025.
Segment Information
The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer and Executive Team members, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating and reportable segment, which is the business of developing and commercializing CAR T therapies.
Inventories, Net
The Company commences capitalization of inventory once regulatory approval for a product candidate is received. Prior to regulatory approval, the Company expensed all such costs as incurred as research and development expenses. The Company capitalizes material costs, labor and applicable overheads that are incurred in the production of its commercial product. Inventory that can be used for either clinical, research or commercial purposes is classified initially as inventory. Inventory that is subsequently used in clinical trials or research activities is expensed once it has been used for research and development purposes.
On November 8, 2024, the Company received the FDA approval for AUCATZYL and commenced capitalization of inventory for AUCATZYL from such date.
Inventories are measured at the lower of cost or net realizable value, with cost determined using a weighted average method for different components of inventory. The Company reviews the recoverability of inventory at each reporting period to determine any changes to net realizable value arising from excess, slow-moving or obsolete inventory. If net realizable value is lower than cost, the inventory will be written down to net realizable value and an impairment charge will be recognized in cost of sales.
Consumables consist of materials used primarily in the quality acceptance testing of AUCATZYL and cleaning of the Company’s commercial manufacturing facility and research and development facilities.
Raw materials inventory consists of completed materials purchased directly from third party suppliers.
Work in progress inventory consists of materials manufactured either by the Company or at contract manufacturing organizations that are either partially manufactured or fully manufactured but are pending quality acceptance release.
Finished goods are completed and quality approved drug products that are either awaiting shipment or are in-transit and therefore have not been delivered to the ATCs.
Product revenue
The Company accounts for its revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The Company has identified a single performance obligation which is satisfied upon delivery of the product to the authorized treatment centers. However, the performance obligation is constrained by the right of return/credit eligibility. The Company recognizes revenue from product sales upon administration to the patient, when the customers’ ability to either cancel the order or request a refund has ceased. Revenue from product sales that are invoiced and constrained is recorded as deferred revenue on the balance sheet.
On April 1, 2025, the Centers for Medicare and Medicaid Services (“CMS”) included AUCATZYL in their published Healthcare Common Procedure Coding System (“HCPCS”) coding determinations and Hospital Outpatient Prospective Payment System (“OPPS”) payment rates, formalizing reimbursement for patients on government programs. The CMS policy splits the therapeutic dose of AUCATZYL into two administrations for coding and billing purposes. As a result, effective from the second quarter of 2025, the Company recognizes 50% of revenue upon administration of the first dose and the remaining 50% of revenue upon administration of the second dose, when the customers’ ability to either cancel the order or request a refund has ceased for each respective dose.
Product revenue, net of gross-to-net deductions, is recognized only to the extent that a significant reversal in the amount of cumulative revenue recognized is not probable of occurring when the uncertainty associated with gross-to-net deductions is subsequently resolved. Product revenue is recognized net of estimated rebates and chargebacks, patient travel assistance and patient co-pay assistance deductions. These deductions to product revenue are referred to as gross-to-net deductions and are estimated and recorded in the period in which the related product revenue occurs.
Gross-to-net deductions
Rebates and chargebacks
Rebates and chargebacks are based on contractual arrangements or statutory requirements and include amounts due to payors and healthcare providers under various programs. These amounts may vary by payor and individual plans. Providers qualified under certain programs can purchase the Company's products through the Company's third-party logistics partner at a discount. The Company's third-party logistics partner then charge the discount back to the Company.
Rebates and chargebacks are estimated primarily based on product sales, including pricing, historical and estimated payor mix, setting of care and discount rates, among other inputs, which require significant estimates and judgment. The Company assesses and updates its estimates each reporting period to reflect actual claims and other current information.
The 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 Program, the DoD, and 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.
The 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.
Patient Travel, Lodging and Meal Assistance
Travel, lodging, and meal assistance represents financial assistance to qualified patients and their caregiver by reimbursing certain travel, lodging, and meal expenses incurred during their treatment. The Company expenses the actual expenses made during the period and accrues the estimated unreported or unrecorded expenses at period end.
Patient Co-Pay Assistance
Co-pay assistance represents financial assistance to qualified patients, assisting them with cost sharing obligations for the Company's product based on benefit design structure required by insurance. The Company's accrual for copay is based on an estimate of claims and the cost per claim that the Company expects to receive associated with qualified patients that exist at each reporting period.
Foreign Currency Translation
The reporting currency of the Company is U.S. dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign currency translation to other comprehensive loss, a component of shareholders’ equity.
The Company recorded foreign exchange losses of $0.9 million and $11.9 million for the three months ended September 30, 2025 and 2024, respectively, and foreign exchange gain of $1.8 million and foreign exchange losses of $12.4 million for the nine months ended September 30, 2025 and 2024, respectively, which are included in foreign exchange (losses) gains, net in the unaudited condensed consolidated statements of operations and comprehensive loss.
Recently Issued Accounting Pronouncements
In September 2025, the Financial Accounting Standards Board (the “FASB”) issued the Accounting Standards Update (“ASU”) 2025-06—Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software to remove all references to prescriptive and sequential software development stages (referred to as “project stages”) throughout Subtopic 350-40. The ASU is effective for all entities for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods. Early adoption is permitted as of the beginning of an annual reporting period. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In July 2025, the FASB issued ASU 2025-05—Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets to provide all entities with a practical expedient and entities other than public business entities with an accounting policy election when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under Topic 606. The ASU is effective for annual reporting periods beginning after December 15, 2025, and interim reporting periods within those annual reporting periods. Early adoption is permitted in both interim and annual reporting periods in which financial statements have not yet been issued or made available for issuance. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In January 2025, the FASB issued ASU 2025-01—Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date, to clarify the effective date of ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. FASB clarified that all public business entities should initially adopt the disclosure requirements in the ASU 2024-04 in the first annual reporting period beginning after December 15, 2026, and interim reporting periods within annual reporting periods beginning after December 15, 2027. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03—Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, to improve the disclosures about entity’s expenses. The amendments apply to all public business entities. The ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027 with early adoption permitted. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In March 2024, the FASB issued ASU 2024-02—Codification Improvements—Amendments to Remove References to the Concepts Statements, that contains amendments to the Codification that remove references to various FASB Concepts Statements. This effort facilitates Codification updates for technical corrections such as conforming amendments, clarifications to guidance, simplifications to wording or the structure of guidance, and other minor improvements. The amendments are effective for public business entities for fiscal years beginning after December 15, 2024, with early adoption permitted. Early application of the amendments in this ASU is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company adopted ASU 2024-02 on January 1, 2025 and will apply ASU 2024-02 prospectively to all new transactions recognized on or after the adoption date. The adoption of ASU 2024-02 did not have material effect on the Company's condensed consolidated financial statements and related disclosures for the three and nine months ended September 30, 2025.
In March 2024, the FASB issued ASU 2024-01—Compensation—Stock Compensation (Topic 718): Scope Application of Profits Interest and Similar Awards, to improve GAAP by adding an illustrative example that includes four fact patterns to demonstrate how an entity should apply the scope guidance in paragraph 718-10-15-3 to determine whether a profits interest award should be accounted for in accordance with Topic 718, Compensation—Stock Compensation. For public business entities, the amendments in this ASU are effective for annual periods beginning after December 15, 2024, and interim periods within those annual periods. Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance. If an entity adopts the amendments in an interim period, it should adopt them as of the beginning of the annual period that includes that interim period. The Company adopted ASU 2024-01 on January 1, 2025. The adoption of ASU 2024-01 did not have material effect on the Company's condensed consolidated financial statements and related disclosures for the three and nine months ended September 30, 2025.
In December 2023, the FASB issued ASU 2023-09—Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The Company does not expect the adoption of ASU 2023-09 to have a material effect on condensed consolidated financial statements and related disclosures for the three and nine months ended September 30, 2025.
Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s condensed consolidated financial statements and disclosures.
Note 3. Revenue
On November 8, 2024, the Company was notified by the FDA that the Company’s BLA was approved, allowing for the marketing of AUCATZYL in the United States for the treatment of adult patients with r/r B-ALL. The first sale of AUCATZYL in the United States occurred in January 2025.
Product revenue, net recognized after estimated deductions for rebates, chargebacks and returns for the three months and nine months ended September 30, 2025, and 2024, is presented in the table below by geographical location (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Product revenue, net | ||||
| United States of America | $21,144 | $— | $51,049 | $— |
| Total Product revenue, net | $21,144 | $— | $51,049 | $— |
During the three and nine months ended September 30, 2025, 100% of the Company's product revenue, net was generated through the Company's agent Cardinal Health 105, LLC (“Cardinal Health”) from ATCs on behalf of patients.
Accounts receivable from contracts with customers
Accounts receivable as of September 30, 2025 and December 31, 2024 was$32.6 million and less than $0.1 million, respectively. An allowance for lifetime expected credit losses on accounts receivable is measured using historical credit loss experience, conditions at the end of each reporting period, and reasonable and supportable forecasts that affect collectability. Expected credit losses as of September 30, 2025 and December 31, 2024, based on the Company's third-party agreements are immaterial.
Deferred revenue
The table below shows the movements in deferred revenue (in thousands):
| Balance as of December 31, 2024 | $— |
|---|---|
| Previously deferred revenue recognized in the period | — |
| Additions to deferred revenue | 7,612 |
| Balance as of September 30, 2025 | $7,612 |
Accruals for rebates, chargebacks and returns
Current accruals for rebates and chargebacks as of September 30, 2025 were as follows (in thousands):
| Rebates | Chargebacks | Total | |
|---|---|---|---|
| As of December 31, 2024 | $— | $— | $— |
| Rebate and chargeback accruals related to product revenue recognized in the period | 2,752 | 1,587 | 4,339 |
| Payments and credits made | (845) | (1,091) | (1,936) |
| As of September 30, 2025 | $1,907 | $496 | $2,403 |
License revenue, net
License revenue for the three and nine months ended September 30, 2025, and 2024, is presented in the table below by geographical location (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| License revenue | ||||
| Europe | $50 | $— | $50 | $10,091 |
| Total License revenue | $50 | $— | $50 | $10,091 |
Major customers
The Company recognized license revenue of less than$0.1 million during the three and nine months ended September 30, 2025. During the nine months ended September 30, 2024, all of the Company’s license revenues were generated from BioNTech.
License and Option Agreement with BioNTech
On February 6, 2024, the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) Registration Rights Agreement, (iii) Letter Agreement and (iv) License and Option Agreement (the “BioNTech License and Option Agreement”), collectively called the “BioNTech Agreements”, with BioNTech.
For further details on the terms and accounting treatment considerations for the BioNTech Agreements, refer to following notes to these interim condensed consolidated financial statements:
Note 13, “Shareholders’ equity”
Note 15, “Liabilities related to future royalties and milestones, net”
Note 17, “Commitments and contingencies”
As the BioNTech License and Option Agreement has been accounted for asone freestanding financial instrument with various embedded features, including the Binder License and related transfer of know-how, Technology Options, and Product Options, the Company is required to consider if the embedded features are required to be bifurcated from the host contract and therefore accounted for as a separate derivative. The Company concluded the Binder License and related transfer of know-how, Technology Options, and Product Options meet the scope exception set out in ASC 815-10-15-59(d) and therefore not accounted for as derivatives under ASC 815, Derivatives and Hedging (“ASC 815”).
Binder License
The Company applied ASC 606 to account for the Binder License and related know-how as functional intellectual property. The Binder License and related transfer of know-how were not distinct from one another and must be combined as a performance obligation, as BioNTech requires the know-how to derive benefit from the license. Based on these determinations, the Company identifiedone combined distinct performance obligation at the inception of the BioNTech License and Option Agreement.
The Company further determined the consideration received included in the transaction price at contract inception, is to be allocated to theone combined performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and Binder License to BioNTech. The Company recognized total license revenue of $10.1 million (net of foreign exchange differences), related to the BioNTech License and Option Agreement during the three months ended March 31, 2024. No license revenue was recognized during the three and nine months ended September 30, 2025.
The Company is eligible to receive milestone payments of up to $32.0 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones. The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which are subject to specified limits. The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders. Under the BioNTech License and Option Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products. Milestone payments and royalty payments are regarded as variable consideration andwill be evaluated under the most likely amount method. Milestone payments and royalty payments were not included in the transaction price, as these amounts were fully constrained as of September 30, 2025 and 2024, respectively.
Technology Options
As the Binder Option and the Activity Enhancement Option, referred to as the “Technology Options”, are outside the scope of ASC 815, the Company considered other relevant accounting guidance to apply to this component of the BioNTech License and Option Agreement. The Company therefore applied ASC 606, considering particularly the accounting guidance related to any options granted to customers to purchase additional goods or services at a future date as this could provide a material right to the customer. A material right is a promise embedded in a current contract that should be accounted for as a separate performance obligation. The Company determined the Technology Options were not offered at a significant and incremental discount. Accordingly, the Technology Options granted to BioNTech do not represent a material right and, therefore, were not a performance obligation at the outset of the arrangement. The Technology Options exercise fee equates to the standalone selling price of the technologies underlying each option and consequently, the transaction price of $10.0 million was not allocated to the Technology Options’ performance obligation. No Technology Options were exercised during the threeand nine months ended September 30, 2025 and 2024, respectively.
Product Options
As theoption to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“Product Options”) are precluded from being accounted for under ASC 815 due to the scope exception, management considered the terms of the Product Options and concluded that they should be accounted for as a gain contingency under the scope of ASC 450, Contingencies(“ASC 450”). The Product Options, unlike the Technology Options, are 1) still subject to negotiation as to the specific activities to be performed by each party, which will be determined and agreed before the Product Options can be exercised, and 2) have not been exercised upon signature of the BioNTech License and Option Agreement. As a result, Product Options are not accounted for under ASC 606, and no recognition is required under ASC 450, until the Product Options are exercised. No Product Options were exercised during the threeand nine months ended September 30, 2025 and 2024, respectively. The product option for AUTO1/22 was not exercised and expired on February 8, 2025.
Note 4. Interest Expense, Net
Interest expense, net consisted of the following (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Interest expense accrued on liabilities related to future royalties and milestones, net | $10,493 | $10,280 | $31,312 | $28,839 |
| Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net | — | — | (17,525) | 10,870 |
| Other interest expense | 27 | 406 | 47 | 420 |
| Total interest expense | $10,520 | $10,686 | $13,834 | $40,129 |
Note 5. Net Loss Per Share
Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Numerator | ||||
| Net loss | $(79,118) | $(82,094) | $(197,196) | $(193,056) |
| Net loss | $(79,118) | $(82,094) | $(197,196) | $(193,056) |
| Denominator | ||||
| Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 266,141,431 | 266,084,589 | 266,136,518 | 251,480,521 |
| Basic and diluted net loss per ordinary share | $(0.30) | $(0.31) | $(0.74) | $(0.77) |
For all periods presented, outstanding but unvested restricted stock units, share options and warrants have been excluded from the calculation, because their effects would be anti-dilutive. Therefore, the weighted average number of ordinary shares used to calculate both basic and diluted loss per share is the same for all periods presented.
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
| September 30, | September 30, | |
|---|---|---|
| 2025 | 2024 | |
| Unvested restricted stock units | 94,375 | 36,186 |
| Share options | 30,312,911 | 20,382,429 |
| Warrants | 3,265,306 | 3,265,306 |
| Total potentially dilutive securities | 33,672,592 | 23,683,921 |
Note 6. Fair Value Measurements
The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in the following levels:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.
The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| September 30, 2025 | ||||
|---|---|---|---|---|
| Aggregate estimated fair value | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |
| Assets classified as cash equivalents: | ||||
| Money market funds | $78,885 | $78,885 | $— | $— |
| $78,885 | $78,885 | $— | $— | |
| Assets classified as marketable securities: available-for-sale debt securities | ||||
| Commercial paper | $48,412 | $— | $48,412 | $— |
| Corporate debt securities | 90,496 | — | 90,496 | — |
| United Kingdom Government Securities | 122,896 | — | 122,896 | — |
| United States Treasury Bills | 19,485 | 19,485 | — | — |
| $281,289 | $19,485 | $261,804 | $— | |
| $360,174 | $98,370 | $261,804 | $— | |
| December 31, 2024 | ||||
|---|---|---|---|---|
| Aggregate estimated fair value | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |
| Assets classified as cash equivalents: | ||||
| Money market funds | $113,447 | $113,447 | $— | $— |
| Commercial paper | 14,301 | — | 14,301 | — |
| United Kingdom Government Securities | 84,255 | — | 84,255 | — |
| United States Treasury Bills | 7,989 | 7,989 | — | — |
| $219,992 | $121,436 | $98,556 | $— | |
| Assets classified as marketable securities: available-for-sale debt securities | ||||
| Commercial paper | $21,141 | $— | $21,141 | $— |
| Corporate debt securities | 151,124 | — | 151,124 | — |
| United Kingdom Government Securities | 141,307 | — | 141,307 | — |
| United States Treasury Bills | 47,071 | 47,071 | — | — |
| $360,643 | $47,071 | $313,572 | $— | |
| $580,635 | $168,507 | $412,128 | $— | |
The Company estimates the fair value of available-for-sale debt securities using actual trade and indicative prices sourced from third-party providers on a daily basis to estimate the fair value. If observable market prices are not available (such as for securities with short maturities and limited second market activity), the securities are priced using a valuation model that maximizes the use of observable inputs, such as market interest rates.
As of September 30, 2025 and December 31, 2024, the Company did not have non-financial assets measured at fair value on a recurring basis. During the three and nine months ended September 30, 2025 and the year ended December 31, 2024, there were no transfers between fair value levels.
Note 7. Marketable Securities: Available-For-Sale Debt Securities
As of September 30, 2025 and December 31, 2024, the Company has the following investments in available-for-sale debt securities, which are categorized as marketable securities: available-for-sale debt securities on the balance sheet depending on their maturity at acquisition (in thousands):
| Remaining contractual maturity | Amortized cost | Gross unrealized gains | Gross unrealized losses | Aggregate estimated fair value | |
|---|---|---|---|---|---|
| Marketable securities: available-for-sale debt securities: | |||||
| Commercial paper | within 1 year | $48,396 | $19 | $(3) | $48,412 |
| Corporate debt securities | within 1 year | 87,407 | 72 | (2) | 87,477 |
| United Kingdom Government Securities | within 1 year | 122,903 | 8 | (15) | 122,896 |
| United States Treasury Bills | within 1 year | 19,433 | 52 | — | 19,485 |
| Corporate debt securities | 1 to 5 years | 3,006 | 13 | — | 3,019 |
| Total | $281,145 | $164 | $(20) | $281,289 | |
| Remaining contractual maturity | Amortized cost | Gross unrealized gains | Gross unrealized losses | Aggregate estimated fair value | |
|---|---|---|---|---|---|
| Marketable securities: available-for-sale debt securities: | |||||
| Commercial paper | within 1 year | $21,145 | $3 | $(7) | $21,141 |
| Corporate debt securities | within 1 year | 91,853 | 5 | (70) | 91,788 |
| United Kingdom Government Securities | within 1 year | 141,376 | — | (69) | 141,307 |
| United States Treasury Bills | within 1 year | 29,663 | 12 | — | 29,675 |
| Corporate debt securities | 1 to 5 years | 59,530 | — | (194) | 59,336 |
| United States Treasury Bills | 1 to 5 years | 17,393 | 7 | (4) | 17,396 |
| Total | $360,960 | $27 | $(344) | $360,643 | |
The number of securities held by the Company and aggregate fair value (in thousands) and in an unrealized loss position as of September 30, 2025 and December 31, 2024 are as follows (in thousands):
| Number of securities held | Gross unrealized losses | Fair market value of investments in an unrealized loss position | |
|---|---|---|---|
| Marketable securities: available-for-sale debt securities in a continuous loss position for less than 12 months: | |||
| Commercial paper | 3 | $(3) | $7,369 |
| Corporate debt securities | 5 | (2) | 14,970 |
| United Kingdom Government Securities | 5 | (15) | 56,536 |
| Total | 13 | $(20) | $78,875 |
| Number of securities held | Gross unrealized losses | Fair market value of investments in an unrealized loss position | |
|---|---|---|---|
| Marketable securities: available-for-sale debt securities in a continuous loss position for less than 12 months: | |||
| Commercial paper | 3 | $(7) | $8,944 |
| Corporate debt securities | 41 | (264) | 133,078 |
| United Kingdom Government Securities | 8 | (69) | 141,307 |
| United States Treasury Bills | 4 | (4) | 9,905 |
| Total | 56 | $(344) | $293,234 |
The aggregated net unrealized loss on available-for-sale debt securities in the amount of $0.1 million has been recognized in accumulated other comprehensive loss in the Company's condensed consolidated balance sheet as of September 30, 2025.
At September 30, 2025, the Company held 13 marketable securities: available-for-sale debt securities out of its total investment portfolio that were in a continuous unrealized loss position. As of September 30, 2025, no allowance for expected credit losses has been recognized in relation to securities in an unrealized loss position. The related unrealized losses are not severe, have been for a short duration and are due to normal market, exchange rate fluctuations and all securities have an investment-grade credit rating. The Company neither intends to sell these investments nor has concluded that it will more-likely-than-not have to sell them before recovery of their carrying values. The Company also believes that it will be able to collect both principal and interest amounts due to the Company at maturity.
There were no amounts reclassified out of other comprehensive income (loss), net of tax during the three and nine months ended September 30, 2025 and during the year ended December 31, 2024.
Note 8. Inventories, Net
Inventories, net consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Consumables | $7,810 | $2,026 |
| Raw materials | 8,754 | 1,956 |
| Work in progress | 8,535 | 16 |
| Finished goods | 2,624 | 140 |
| Total inventories, net | $27,723 | $4,138 |
Inventory reserves as of September 30, 2025 and December 31, 2024 amounted to $5.4 million andnil, respectively. 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. There wereno inventory reserves recorded for the three and nine months ended September 30, 2024.
Note 9. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Research and development claims receivable | $48,505 | $38,242 |
| Prepayments | 23,206 | 15,212 |
| VAT receivable | 5,833 | 5,996 |
| Deferred cost | 3,378 | 2,320 |
| Accrued interest income | 1,796 | 2,566 |
| Other taxes receivable | 1,685 | 1,571 |
| Other receivables | 936 | 1,421 |
| Total prepaid expenses and other current assets | $85,339 | $67,328 |
Note 10. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Lab equipment | $46,106 | $41,728 |
| Office equipment | 6,692 | 6,330 |
| Furniture and fixtures | 2,545 | 2,359 |
| Leasehold improvements | 15,136 | 14,116 |
| Assets under construction | 39,153 | 19,638 |
| Less: accumulated depreciation | (42,781) | (34,618) |
| Total property and equipment, net | $66,851 | $49,553 |
Depreciation expense for the three months ended September 30, 2025 and 2024 was $2.1 million and $1.9 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $6.2 million and $5.6 million, respectively.
Note 11. Intangible Assets, Net
The following table summarizes the carrying amount of the Company's intangible assets, net of accumulated amortization (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Licensed IP rights | $21,505 | $12,535 |
| Software licenses | 49 | — |
| Less: accumulated amortization | (1,271) | (162) |
| Total intangibles assets, net | $20,283 | $12,373 |
Amortization expense for the three months ended September 30, 2025 and 2024 was $0.5 million andnil, respectively, and for the nine months ended September 30, 2025 and 2024 was $1.0 million andnil, respectively. The estimated annual amortization expense related to this asset is $2.0 million for each of the five years ending in 2030.
On July 18, 2025, the Company was notified by the European Commission that the Company has been granted marketing approval for AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients (26 years and older) with r/r B-ALL which triggered a £6.0 million regulatory milestone payment that was paid by the Company during the three months ended September 30, 2025 in accordance with the UCLB License Agreement.
Note 12. Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Compensation and benefits | $22,611 | $19,681 |
| Professional fees | 8,782 | 9,075 |
| Research and development costs | 5,990 | 13,372 |
| Manufacturing accruals | 5,946 | 6,075 |
| VAT accrual | 4,171 | 3,594 |
| Rebates, chargebacks and returns | 2,403 | — |
| Other liabilities | 2,361 | 479 |
| Total accrued expenses and other liabilities | $52,264 | $52,276 |
Note 13. Shareholders’ Equity
Ordinary Shares
Each holder of ordinary shares is entitled toone vote per ordinary share and to receive dividends when and if such dividends are recommended by the Company’s board of directors and declared by the shareholders. As of September 30, 2025, the Company has not declared any dividends.
Restricted Stock Units
At September 30, 2025, restricted stock unit awards for 1,875 ordinary shares had vested but the underlying shares had not been issued. However, these vested restricted stock unit awards have been included in the calculation of the Company’s outstanding shares at September 30, 2025 as they are considered issuable for little or no cash consideration. Subsequent to September 30, 2025,1,875 of the underlying ordinary shares were issued.
February 2024 Underwritten Offering
On February 12, 2024, the Company completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were$326.8 million.
BioNTech Securities Purchase Agreement
Concurrently with the execution of the BioNTech License and Option Agreement (see Note 3 and Note 15), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement pursuant to which the Company sold ADSs, each representingone ordinary share, to BioNTech in a private placement transaction(the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were$193.8 million.
In the event that BioNTech and the Company entered into a joint manufacturing and commercial services agreement(“MCSA”)within 18 months of the initial closing of the Private Placement, BioNTech would have purchase up to 15,000,000 ADSs for an aggregate purchase price of up to $20.0 million, subject to additional limitations and restrictions. On August 6, 2025, the MCSA option expired unexercised.
Note 14. Share-Based Compensation
2025 Employee Share Purchase Plan
In May 2025, the Company's board of directors adopted the 2025 Employee Share Purchase Plan (the “Purchase Plan” or “ESPP”), which became effective upon approval by the Company's shareholders in June 2025. The following description of the Purchase Plan is a summary only and is qualified in its entirety by reference to the complete text of the Purchase Plan. Subject to adjustment for certain changes in the Company's capitalization, the maximum number of Shares (as defined therein) that may be issued under the Purchase Plan is 3,000,000. The Purchase Plan includes both (i) a 423 Component (as defined therein), which is intended to be used to grant rights to purchase Shares which qualify as options issued under an “employee stock purchase plan” as that term is defined in Section 423(b) of the U.S. Internal Revenue Code of 1986, as amended (the “Code”), and (ii) a Non-423 Component (as defined therein), which is intended to be used to grant rights to purchase Shares which do not qualify for such treatment under the Code. The UK Sharesave Sub-Plan has been adopted as a sub-plan to the Purchase Plan. The Sharesave is a UK 'all employee' share option plan, which is intended to satisfy the requirements of Schedule 3 of ITEPA for tax qualifying save-as-you-earn share options plans. The Purchase Plan, including any sub-plans, is administered by the Company's board of directors, which may delegate such administration to a committee comprised of one or more members of the board. The plan administrator has the power, subject to the provisions of the Purchase Plan, to determine when and how rights to purchase the Company's shares will be granted, the provisions of each offering of such rights (which need not be identical), and whether employees of any of Autolus parent or subsidiary companies will be eligible to participate in the Purchase Plan. The Company has not yet initiated any purchase periods or granted shares under the ESPP as of September 30, 2025.
2025 Inducement Plan
The Company's 2025 Inducement Plan (the “2025 Inducement Plan”) became effective on March 27, 2025 and, in accordance with Nasdaq listing rules and the SEC requirements, provides for issuance of inducement equity awards to qualifying individuals in connection with their entering into employment with the Company or its affiliates. Awards granted under the 2025 Inducement Plan will not exceed 3,000,000 ADSs, representing an equal number of ordinary shares. As of September 30, 2025,354,700 shares are reserved for issuance under the 2025 Inducement Plan. Equity awards granted under the 2025 Inducement Plan generally vest in the same manner as other Company awards, with 25% of the awards vestingone year after the vesting commencement date and the remainder of the awards vesting in equal monthly installments over three additional years.
The following table summarizes the total share-based compensation expense included in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Research and development expenses | $1,266 | $1,218 | $3,792 | $2,716 |
| Selling, general and administrative expenses | 2,166 | 2,802 | 6,207 | 6,525 |
| Cost of sales | 456 | — | 1,070 | — |
| Capitalized to intangibles, net / property and equipment, net | (53) | — | (74) | (2) |
| Total share-based compensation expense | $3,835 | $4,020 | $10,995 | $9,239 |
Share Options
The table below summarizes Company’s share option activity during the nine months ended September 30, 2025:
| Number of Options | Weighted- Average Exercise Price per share | Weighted- Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value (1)(in thousands) | |
|---|---|---|---|---|
| Outstanding as of December 31, 2024 | 20,754,316 | $5.41 | 7.78 | $1,536 |
| Granted | 11,724,397 | 1.93 | — | |
| Forfeited | (1,239,036) | 2.39 | — | |
| Expired | (926,766) | 5.23 | — | |
| Outstanding as of September 30, 2025 | 30,312,911 | $4.20 | 7.93 | $80 |
| Exercisable as of September 30, 2025 | 13,659,568 | $6.45 | 6.62 | $80 |
| Vested and expected to vest as of September 30, 2025 | 30,312,911 | $4.2 | 7.93 | $80 |
| (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of September 30, 2025. | ||||
The weighted average grant-date fair value of share options granted was $1.39 per share option for the nine months ended September 30, 2025. The weighted average grant-date fair value of share options granted was $3.02 per share option for the nine months ended September 30, 2024.
The total intrinsic value of share options exercised wasnil for the nine months ended September 30, 2025. The total intrinsic value of options exercised was $0.5 million for the nine months ended September 30, 2024.
As of September 30, 2025, the total unrecognized compensation expense related to unvested share options without performance conditions was $14.7 million, which the Company expects to recognize over a weighted average vesting period of 3.05 years.
Restricted Stock Units
The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the nine months ended September 30, 2025:
| Number of restricted units | Weighted average grant date fair value | |
|---|---|---|
| Unvested and outstanding at December 31, 2024 | 32,412 | $4.22 |
| Granted | 80,000 | 1.50 |
| Vested | (17,949) | 4.41 |
| Forfeited | (88) | 6.20 |
| Unvested and outstanding at September 30, 2025 | 94,375 | $1.88 |
As of September 30, 2025, there was $0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which is expected to be recognized over a weighted average period of 3.72 years.
Note 15. Liabilities Related to Future Royalties and Milestones, Net
The following table summarizes the carrying amount of the Company's liabilities related to future royalties and milestones, net (in thousands):
| Balance at December 31, 2024 | $248,100 | |
|---|---|---|
| Interest expense accrued on liabilities related to future royalties and milestones, net | 31,312 | |
| Cumulative catch-up adjustment | (17,525) | |
| Revenue share payments (royalties) | (2,542) | |
| Balance at September 30, 2025 | $259,345 |
The following table summarizes the current versus non-current split of the liabilities related to future royalties and milestones, net (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Current portion of liabilities related to future royalties and milestones, net | $7,400 | $3,500 |
| Non-current portion of liabilities related to future royalties and milestones, net | 251,945 | 244,600 |
| Total liabilities related to future royalties and milestones, net | $259,345 | $248,100 |
During the three months ended September 30, 2025 and 2024, interest expense on liabilities related to future royalties and milestones, net amounted to $10.5 million and $10.3 million, respectively. During the nine months ended September 30, 2025 and 2024, interest expense on liabilities related to future royalties and milestones, net amounted to $31.3 million and $28.8 million, respectively.
There wereno cumulative catch-up adjustments for the three months ended September 30, 2025 and 2024, respectively. During the nine months ended September 30, 2025 and 2024, the cumulative catch-up adjustments amounted to $17.5 million and $10.9 million, respectively.
Blackstone Collaboration Agreement
On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”): (i) Strategic Collaboration Agreement (the “Blackstone Collaboration Agreement”), (ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), (iii) Warrant Agreement (the “Blackstone Warrant”) and (iv) Registration Rights Agreement (the “Blackstone Registration Rights Agreement”). The Blackstone Collaboration Agreement, the Blackstone Securities Purchase Agreement, the Blackstone Warrant and the Blackstone Registration Rights Agreement are collectively referred to as the “Blackstone Agreements”. The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for the Blackstone Agreements in the aggregate.
For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report:
Note 12, “Liabilities related to future royalties and milestones, net”
Note 13,“Warrants”
Note 14, “Shareholders’ equity”
In November 2021, the upfront payment of $50.0 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement. In December 2022, two Blackstone Development Payments were paid by Blackstone of $35.0 million each as a result of (i) the joint steering committee’s review of the Company’s interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in r/r B-ALL and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process. On November 8, 2024, the Company was notified by the FDA that the Company has been granted marketing approval for AUCATZYL for the treatment of adult patients (18 years and older) with r/r B-ALL. The remaining $30.0 million of Blackstone Development Payments due upon such approval were paid to the Company in December 2024.
On February 6, 2024, the Company concurrently entered into the BioNTech Agreements. The BioNTech Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate. The following descriptions of the BioNTech Agreements do not purport to be complete and are qualified in their entirety by reference to the full texts of such agreements.
For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report:
Note 1, “Nature of the business”
Note 3, “Revenue”
Note 12, “Liabilities related to future royalties and milestones, net”
Note 14, “Shareholders’ equity”
Note 20, “Commitments and contingencies”
Obe-cel Product Revenue Interest
Under the BioNTech License and Option Agreement, BioNTech has agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40.0 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election. The Company has accounted for the Obe-cel Product Revenue Interest as a liability primarily due to the Company’s significant continuing involvement in generating the royalty stream. In February 2024, the Company initially recognized the BioNTech Liability at $38.3 million being the face value less debt issuance costs.
Manufacturing and Commercial Services Agreement
Under the terms of the BioNTech License and Option Agreement, the Company agreed to grant BioNTech the option to negotiate a joint MCSA, pursuant to which the parties would have accessed and leveraged each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211. The MCSA, if entered into, would also have granted BioNTech access to the Company’s commercial site network and infrastructure. On August 6, 2025, the MCSA option expired unexercised.
The carrying amount of the Blackstone Collaboration Liability and BioNTech Liability is based on the Company’s estimate of the future royalties to be paid to BioNTech to be received over the life of the arrangement as discounted using an effective interest rate. The excess or deficit of estimated present value of future royalties over the initial carrying amount, is recognized using the cumulative catch-up method within interest expense using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the Blackstone Collaboration Liability and BioNTech Liability was approximately 15.80% and 28.70% as of September 30, 2025, respectively.
On a quarterly basis, the Company assesses the amount and timing of expected royalty using a combination of internal projections and forecasts from external sources. To the extent the present value of such payments is greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will adjust the amortization of the BioNTech Liability using the cumulative catch-up method.
Note 16. Leases
Operating leases - Lessee
The Company leases certain office space, laboratory space, and equipment. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present.
The Company’s costs as a lessee for the three and nine months ended September 30, 2025 and 2024 were as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Operating lease costs | $2,154 | $2,155 | $6,462 | $6,340 |
| Variable costs | 676 | 157 | 1,428 | 1,186 |
| Short term lease costs | 115 | 72 | 229 | 276 |
| Total lease costs | $2,945 | $2,384 | $8,119 | $7,802 |
Supplemental cash flow information for the nine months ended September 30, 2025 and 2024 were as follows (in thousands):
| Nine Months Ended September 30, | ||
|---|---|---|
| Other information | 2025 | 2024 |
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash (inflows) outflows from operating leases(1) | $(5,589) | $7,067 |
| (1) Includes lease incentives received during the nine months ended September 30, 2025 relating to the Company's Nucleus facility lease. | ||
The weighted average remaining lease term and weighted average discount rate of operating leases as of September 30, 2025 and 2024 were as follows:
| Nine Months Ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Weighted-average remaining lease term - operating leases | 16.1 years | 15.6 years |
| Weighted-average discount rate - operating leases | 8.17% | 8.14% |
The maturities of operating lease liabilities as of September 30, 2025 were as follows (in thousands):
| 2025 | $2,806 |
| 2026 | 9,572 |
| 2027 | 8,961 |
| 2028 | 8,193 |
| 2029 | 6,161 |
| Thereafter | 83,016 |
| Total lease payments | 118,709 |
| Less: imputed interest | (52,874) |
| Present value of lease liabilities | $65,835 |
Note 17. Commitments and Contingencies
License Agreements
The Company has entered into an exclusive license agreement, as amended (the “UCLB License Agreement”), with UCL Business Ltd (“UCLB”). In connection with the UCLB License Agreement, the Company is required to make annual license payments and may be required to make payments to UCLB upon the achievement of specified milestones, including upon regulatory approval for obe-cel. During the three and nine months ended September 30, 2025, less than $0.1 million was paid or payable to UCLB by the Company, relating to the income allocable to the value of the sublicensed intellectual property rights.
On July 18, 2025, the Company was notified by the European Commission that the Company has been granted marketing approval for AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients (26 years and older) with r/r B-ALL which triggered a £6.0 million regulatory milestone payment that was paid by the Company during the three months ended September 30, 2025 in accordance with the UCLB License Agreement. The Company recognized the regulatory milestone payment as an intangible asset.
Contractual obligations
In July 2022, the Company renegotiated a master services agreement with Adaptive Biotechnologies Corporation (“Adaptive”), under which Adaptive's assay is used to analyze patient samples from r/r B-ALL patients. During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract. Under the then-current agreement, the Company would be obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company’s use of the Adaptive assay.
In previous periods, the Company has entered into agreements with certain advisory firms. The Company is obligated to make specified payments upon the achievement of certain strategic transactions involving the Company. During the three and nine months ended September 30, 2024, the Company paid a fee under these agreements. There were no fees paid or payable to strategic advisory firms during the three and nine months ended September 30, 2025.
The Company has estimated the probability of the Company achieving each potential milestone in relation to the agreements with UCLB and its agreements with certain advisory firms in accordance with ASC 450. The Company considers regulatory approval, commercial milestones and execution of collaboration agreements probable when actually achieved. Furthermore, the Company recognizes expenses for clinical milestones when their achievement is deemed probable. The Company concluded that as of September 30, 2025, there were no other milestones for which the likelihood of achievement was currently probable.
Capital Commitments
As of September 30, 2025, the Company’s unconditional purchase obligations for capital expenditures totaled $7.0 million and included signed orders for capital equipment and capital expenditures for construction and related expenditures relating to its properties in the United Kingdom and the United States. The Company expects to incur the full amount of these obligations withinone year.
Master Supply Commitments
As of September 30, 2025, the Company’s unconditional purchase obligations with Miltenyi Biotec GmbH for reagents and consumables totaled $2.8 million, which the Company expects to incur withinone year.
BioNTech License and Option Agreement - Product Options gain contingency
As the Product Options within the BioNTech License and Option Agreement were an embedded feature within a freestanding financial instrument, the Company assessed if the Product Options should be accounted for as a derivative under ASC 815. However, the Company determined the Product Options met the scope exception for derivative accounting under ASC 815 and therefore should be accounted for a gain contingency under the scope of ASC 450. As of September 30, 2025 and December 31, 2024, the Product Options were not exercised and, therefore, no amounts were recognized.
Refer to Note 15, “Liabilities related to future royalties and milestones, net” for further details about the BioNTech Agreements.
Legal Proceedings
From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. The Company was not a party to any litigation and didnot have contingency reserves established for any liabilities as of September 30, 2025 and December 31, 2024.
Indemnification Agreements
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because they involve claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations.
In accordance with the indemnification agreements entered into with relevant individuals in accordance with the Company’s Articles of Association, the Company has indemnification obligations to its directors, officers and members of senior management for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity.
There have been no claims to date under these indemnification agreements, and the Company has director and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims.
SME Research and Development (R&D) tax credit
In the accounting period to December 2023, based on the relevant tax legislation, the Company met the conditions of the R&D intensive scheme, and therefore submitted its corporate tax return on this basis. This is subject to agreement by the United Kingdom tax authority. The tax authority's non-statutory guidance, includes some expenditure in the calculation of whether a company meets the R&D intensive scheme, which is in conflict with the criteria in the tax legislation. The position is uncertain and the legislation is currently untested in the United Kingdom courts. If the Company's claim is unsuccessful, normal SME relief will be available and there will be a material reduction in the value of the tax credit obtained (18.6% as opposed to 26.97% net benefit). Should the uncertainty be resolved in the Company’s favor, this would result in a gain and would be accounted for as a gain contingency under the scope of ASC 450. This uncertainty only applies to one accounting period.
Note 18. Segment Reporting
Long-lived assets
Long-lived assets (excluding intangibles, deferred tax and financial instruments) were located as follows (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| United Kingdom | $122,145 | $104,160 |
| United States of America | 534 | 891 |
| Total long-lived assets | $122,679 | $105,051 |
Revenue
Revenue recognized by geographic area are disclosed in Note 3,“Revenue”.
Segment loss
The table below is a summary of the segment loss, including significant segment expenses (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Product Revenue, net | $21,144 | $— | $51,049 | $— |
| License Revenue | 50 | — | 50 | 10,091 |
| Less: | ||||
| Cost of sales | (28,643) | — | (71,039) | — |
| Research and clinical development | (16,112) | (9,990) | (45,231) | (25,961) |
| Product delivery | (5,205) | (26,357) | (15,170) | (69,943) |
| Commercial and Medical affairs | (20,533) | (15,413) | (52,488) | (33,960) |
| Support functions | (24,085) | (13,344) | (60,908) | (38,082) |
| Other segment income (expenses), net (1) | 1,763 | (2,772) | (4,341) | (7,707) |
| Total operating expenses | (92,815) | (67,876) | (249,177) | (175,653) |
| Operating loss | (71,621) | (67,876) | (198,078) | (165,562) |
| Other income, net | 84 | 54 | 349 | 161 |
| Foreign exchange (losses) gains, net | (911) | (11,884) | 1,769 | (12,368) |
| Interest income | 4,382 | 8,320 | 15,753 | 24,908 |
| Interest expense, net | (10,520) | (10,686) | (13,834) | (40,129) |
| Income tax expenses | (532) | (22) | (3,155) | (66) |
| Segment and consolidated net loss | $(79,118) | $(82,094) | $(197,196) | $(193,056) |
| (1) Other segment income (expenses), net include United Kingdom research and development tax credits, depreciation, amortization and share-based compensation expenses. | ||||
Note 19. Related Party Transactions
Blackstone Agreements
In November 2021, the Company concurrently entered into the Blackstone Agreements. As of the execution of the Blackstone Agreements, Blackstone became a related party of the Company, as Blackstone became the owner of more than 10% of the Company’s outstanding voting securities. In addition, Blackstone received and exercised its right to nominateone director to the board of directors of the Company and is therefore considered to be one of the principal owners of the Company. As of September 30, 2025, Blackstone holds more than 5% of the Company's outstanding voting securities.
As of September 30, 2025, the carrying amount of the Blackstone Collaboration Agreement Liability was $219.5 million. For the nine months ended September 30, 2025, the aggregated cumulative non-cash interest expense and cumulative catch-up adjustment amounted to $9.5 million and the revenue share payments amounted to $1.6 million. As of December 31, 2024, the carrying amount of the Blackstone Collaboration Agreement Liability was $211.6 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $10.7 million. Refer to Note 15,“Liabilities related to future royalties and milestones, net” for further details.
In February 2024, the Company concurrently entered into the BioNTech Agreements. Upon the execution of the BioNTech Agreements, BioNTech became a related party of the Company. BioNTech owns more than 10% of the Company’s outstanding voting securities and is therefore one of the principal owners of the Company. In addition, BioNTech has the right to nominateone director to the board of directors of the Company, which BioNTech has not yet exercised.
As of September 30, 2025, the carrying amount of the BioNTech Liability was $39.9 million. For the nine months ended September 30, 2025, the aggregated cumulative interest expense and cumulative catch-up adjustment amounted to $4.3 millionand the revenue share payments amounted to $0.9 million. As of December 31, 2024, the carrying amount of the BioNTech Liability was $36.5 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $1.8 million. Refer to Note 15, “Liabilities related to future royalties and milestones, net” for further details.
Note 20. Subsequent Events
The Company evaluated subsequent events through November 12, 2025, the date on which these unaudited condensed consolidated financial statements were issued.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.