Autolus Therapeutics plc

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes to those statements included in this Quarterly Report on Form 10-Q. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and the notes thereto, which appear in our Annual Report as filed with the SEC.

Current wording

The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated interim financial statements and the related notes to those statements included in this Quarterly Report on Form 10-Q. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and the notes thereto, which appear in our Annual Report on the Form 10-K for the year ended December 31, 2024 as filed with the Securities and Exchange Commission, or the SEC on March 20, 2025, or the Annual Report.

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 Cash Flows for the three months ended September 30, 2024 and 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3008 and £1.00 to $1.2657, respectively. Our unaudited condensed Consolidated statements of Operations and Comprehensive Loss and Cash Flows for the nine months ended September 30, 2024 and 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2768 and £1.00 to $1.2439, respectively. Our unaudited condensed Consolidated Balance Sheet as of September 30, 2024 and audited Consolidated Balance Sheet as of December 31, 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3387 and £1.00 to $1.2730, 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 March 31, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2588 and £1.00 to $1.2680, respectively. Our unaudited condensed consolidated balance sheet as of March 31, 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 $1.2935 and £1.00 to $1.2618, 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 September 30, 2024 and 2023, we incurred net losses of $82.1 million and $45.8 million, respectively, and net losses of $193.1 million and $131.2 million for the nine months ended September 30, 2024 and 2023, respectively, and had an accumulated deficit of $1,071.6 million and $878.6 million as of September 30, 2024 and December 31, 2023, respectively.

Current wording

Since our inception, we have incurred significant operating losses. For the three months ended March 31, 2025 and 2024, we incurred net losses of $70.2 million and $52.7 million, respectively, and had an accumulated deficit of $1,169.4 million and $1,099.2 million as of March 31, 2025 and December 31, 2024, respectively.

Previous wording

As of September 30, 2024, we had cash and cash equivalents of $657.1 million. Based on our current clinical development and commercialization plans, we believe our existing cash and cash equivalents 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 report.

Current wording

As of March 31, 2025, we had cash and cash equivalents of $95.8 million and marketable securities of $420.8 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 account for our revenue pursuant to the provisions of ASC 606, Revenue from Contracts with Customers. Prior to the approval of AUCATZYL on November 8, 2024, we had no products approved for commercial sale, and we have not generated any revenue from commercial product sales as of September 30, 2024. The total revenue to date has been generated principally from out-licensing agreements. As of September 30, 2024, we had entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on licensed product sales.

Current wording

We account for our revenue pursuant to the provisions of ASC 606. As of March 31, 2025, we have entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on licensed product sales.

Previous wording

Research and development expenses (“R&D”) consist of costs incurred in connection with the research and development of our product candidates, which are partially offset by research and development tax credits, including tax credits arising from the U.K. small and medium enterprise (“SME”) regime and research and development expenditure credit (“RDEC”) regime provided by HMRC. We expense research and development costs as incurred. These expenses include:

Current wording

Research and development expenses, net (“R&D”) consist of costs incurred in connection with the research and development of our product candidates, which are partially offset by research and development tax credits, including tax credits arising from the U.K. small and medium enterprise (“SME”) regime and research and development expenditure credit (“RDEC”) regime provided by His Majesty's Revenue and Customs (“HMRC”). We expense research and development costs as incurred. These expenses include:

Previous wording

After consultation, we have been advised by His Majesty Revenue and Customs (“HMRC”)that any sale of our obe-cel CAR T therapy to U.K. customers in the future will be considered an exempt supply from a U.K. VAT perspective. Consequently, we have assessed and restricted the amount of U.K. VAT we have historically reclaimed and will continue to do so in the future. The restriction will be based on the estimated U.K. market turnover as a percentage of global turnover. We currently expect revenue from U.K. customers to only represent a small proportion of our overall activity. If the proportion of revenue from U.K. customers increases this would further restrict the amount of U.K. input VAT recovered. Included in research and development expenses is historical irrecoverable input VAT previously claimed on research and development expenses and subsequently reversed.

Current wording

After consultation, we have been advised by HMRC that any sale of our obe-cel CAR T therapy to United Kingdom customers in the future will be considered an exempt supply from a United Kingdom VAT perspective. Consequently, we have assessed and restricted the amount of United Kingdom VAT we have historically reclaimed and will continue to do so in the future. The restriction will be based on the estimated United Kingdom market turnover as a percentage of global turnover. We currently expect revenue from United Kingdom customers to only represent a small proportion of our overall activity. If the proportion of revenue from United Kingdom customers increases this would further restrict the amount of United Kingdom input VAT recovered. Included in research and development expenses is historical irrecoverable input VAT previously claimed on research and development expenses and subsequently reversed.

Previous wording

We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the European Medicines Agency (“EMA”), the FDA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. Commercialization of our product candidates will take several years and millions of dollars in development costs.

Current wording

We may never succeed in achieving regulatory approval for any of our product candidates other than AUCATZYL. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the European Medicines Agency (“EMA”), the FDA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. Commercialization of our product candidates will take several years and millions of dollars in development costs.

Previous wording

The SME regime has been particularly beneficial to us, as under this regime the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 18.6% of qualifying expenditure incurred after April 1, 2023. Qualifying expenditures largely comprise 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 in relation 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 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.

Previous wording

On April 1, 2023, the headline rate under the RDEC regime increased from 13% to 20% and can generate cash rebates of up to 15% (increased from 10.5%) on qualifying R&D expenditure incurred from this date.

Current wording

Under the RDEC program, the headline rate for qualifying R&D expenditure is 20% and can generate cash rebates of up to 15% on qualifying R&D expenditure.

Previous wording

Amendments to the current SME and RDEC programs that are contained in the Finance Act 2024 which was enacted on February 22, 2024 will take effect from periods on or after April 1, 2024 and will (i) (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on subcontracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the U.K. or such workers are not subject to U.K. 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. Nevertheless, the higher rate of 27% for R&D intensive SME companies will still be in effect from periods on or 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 take effect from periods commencing after April 1, 2024.

Previous wording

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. 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 general and administrative expenses is historical irrecoverable input VAT previously claimed on 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 and audit services. Included in general and administrative expenses is historical irrecoverable input VAT previously claimed on general and administrative expenses and subsequently reversed.

Previous wording

We have experienced, and expect to continue to experience, increased expense with being a public company, including increased accounting, audit, legal, regulatory and compliance costs associated with maintaining compliance with Nasdaq listing rules and SEC requirements, director and officer insurance premiums, as well as higher investor and public relations costs. Additionally, should we fail to maintain our status as a foreign private issuer, we would expect to incur increased expenses to remain compliant with applicable SEC and Nasdaq requirements.

Current wording

We have experienced, and expect to continue to experience, increased expense with being a public company, including increased accounting, audit, legal, regulatory and compliance costs associated with maintaining compliance with Nasdaq listing rules and the SEC requirements, director and officer insurance premiums, as well as higher investor and public relations costs. Additionally, should we fail to maintain our status as a foreign private issuer, we would expect to incur increased expenses to remain compliant with applicable SEC and Nasdaq requirements.

Previous wording

Other income (expense), net consists primarily sublease income and gains or losses arising from the termination of leases.

Current wording

Other income (expense), net consist primarily of sublease income and gains or losses arising from the termination of leases.

Previous wording

Foreign exchange (losses) gains consists primarily of foreign currency transaction gains and losses arising from transactions denominated in foreign currencies.

Current wording

Foreign exchange gains (losses), net primarily consist of foreign currency transaction gains and losses arising from transactions denominated in foreign currencies.

Previous wording

Interest expense consists primarily of interest expense arising from amortization of the liability related to future royalties and milestones, pursuant to our collaboration agreements with Blackstone and BioNTech, using the effective interest rate method. On a quarterly basis, we assess the expected present value of the future Blackstone and BioNTech payments under the Blackstone Collaboration Agreement and BioNTech Agreements which may be received by us and future royalties and sales milestone payments to Blackstone and BioNTech which may be paid by us. To the extent the amount or timing of such receipts or payments is materially different than our previous estimates we record a cumulative catch-up adjustment to the liability related to future royalties and milestones. The adjustment to the carrying amount is recognized as an adjustment to interest expense in the period in which the change in estimate occurred.

Current wording

Interest expense, net consists primarily of interest expense arising from amortization of the liabilities related to future royalties and milestones, pursuant to our collaboration agreements with BXLS V - Autobahn L.P, (“Blackstone”) and BioNTech SE (“BioNTech”), using the effective interest rate method. On a quarterly basis, we assess the expected present value of the future Blackstone and BioNTech payments under the Blackstone Collaboration Agreement and BioNTech Agreements which may be received by us and future royalties and sales milestone payments to Blackstone and BioNTech which may be paid by us. To the extent the amount or timing of such receipts or payments is materially different than our previous estimates we record a cumulative catch-up adjustment to the liabilities related to future royalties and milestones. The adjustment to the carrying amount is recognized as an adjustment to interest expense in the period in which the change in estimate occurred.

Previous wording

We are subject to corporate taxation in the United Kingdom, United States, Germany and Switzerland. Due to the nature of our business, we have generated losses since inception. Our income tax benefit (expense) recognized represents the sum of the research and development tax credits recoverable in the U.K. and offset by income tax payable in the United States.

Current wording

We are subject to corporate taxation in the United Kingdom, United States, Germany and Switzerland. Due to the nature of our business, we have generated losses since inception. Our income tax (expense) benefit recognized represents the sum of income tax payable or receivable in the United Kingdom and in the United States.

Previous wording

Un-surrendered U.K. 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 U.K. taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the U.K. of $418.1 million at December 31, 2023. A valuation allowance has been recognized against our deferred tax asset relating to our U.K. losses. We carried a $3.4 million deferred tax asset balance related to the U.S. entity at September 30, 2024 for which there is no valuation allowance. At September 30, 2024, we recorded a full valuation allowance against the net deferred tax asset in the U.K., as the recoverability due to future taxable profits was uncertain. On April 1, 2023, the main rate of the U.K. corporation tax was increased to 25% for companies with profits in excess of £250,000, or the small profits rate of 19% for companies with profits of £50,000 or less (with marginal relief from the main rate available to companies with profits between £50,000 and £250,000).

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 $2.8 million deferred tax asset balance related to the United States entity at March 31, 2025 for which a valuation allowance of $1.8 million was applied. At March 31, 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

In the event we generate revenues in the future, we may benefit from the U.K. “patent box” regime that allows profits attributable to revenues from patents or patented products to be taxed at an effective rate of 10%.

Current wording

In the event we generate revenues in the future, we may benefit from the United Kingdom “patent box” regime that allows profits attributable to revenues from patents or patented products to be taxed at an effective rate of 10%.

Previous wording

License revenue amounting to $10.1 million for the nine months ended September 30, 2024 related to license revenue recognized pursuant to the License and Option Agreement with BioNTech. License revenue of $1.7 million for the nine months ended September 30, 2023 primarily related to the execution of the Cabaletta Bio Inc. (“Cabaletta”) Option and License Agreement, which included recognition of a non-refundable license fee and license revenue from an investee of Syncona Portfolio Limited, which is a holder of more than 10% of our share capital.

Current wording

We did not recognize any license revenues during the three months ended March 31, 2025. License revenue amounting to $10.1 million for the three months ended March 31, 2024, relates to license revenue recognized pursuant to the License and Option Agreement with BioNTech.

Previous wording

•an increase of $1.6 million in U.K. R&D tax credits (decrease in R&D expense) due primarily to an increase in qualifying research and development expenditures related to the SME scheme, and

Current wording

•a decrease of $1.1 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 $1.7 million in legal and professional fees related to our general and administrative activities,

Current wording

•an increase of $1.7 million in commercial readiness costs including legal and professional fees due to increased commercial readiness activities being undertaken; and

Previous wording

•an increase of $0.9 million related to information technology infrastructure and support for information systems related to the conduct of corporate and commercial operations, and

Current wording

•an increase of $1.7 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

Interest income increased to $8.3 million for the three months ended September 30, 2024, as compared to $3.6 million for the three months ended September 30, 2023. The increase in interest income of $4.7 million primarily related to increase in yield and also higher account balances associated with our cash and cash equivalents during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023.

Current wording

Interest income decreased to $6.1 million for the three months ended March 31, 2025, as compared to $6.9 million for the three months ended March 31, 2024. The decrease in interest income of $0.8 million primarily relates to lower aggregate balances associated with our cash, cash equivalents and marketable securities during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024.

Previous wording

Interest expense increased to $10.7 million for the three months ended September 30, 2024 as compared to $5.0 million for the three months ended September 30, 2023. Interest expense increased by $5.7 million primarily due to an increase in the balance of the liabilities for future royalties and milestones, net associated with our Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement which was executed in February 2024.

Current wording

Interest expense, net decreased to $10.1 million for the three months ended March 31, 2025 as compared to $19.3 million for the three months ended March 31, 2024. Interest expense, net decreased by $9.1 million primarily due to lower liabilities related to future royalties and milestone, net balances as of March 31, 2025 compared to March 31, 2024 in relation to the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement.

Previous wording

Since our inception, we have not generated any commercial product revenue and have incurred operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses for the foreseeable future as we market AUCATZYL and advance our other product candidates through preclinical and clinical development and seek regulatory approval and pursue commercialization of any additional approved products. As a result, we will need significant additional capital to fund our operations until such time as we can generate significant revenue from sales of AUCATZYL or other products.

Current wording

We expect to incur significant expenses and operating losses for the foreseeable future as we market AUCATZYL and advance our other product candidates through preclinical and clinical development and seek regulatory approval and pursue commercialization of any additional approved products. As a result, we will need significant additional capital to fund our operations until such time as we can generate significant revenue from sales of AUCATZYL or other products.

Previous wording

As of November 8, 2024, we have one product approved for commercial sale in the United States, AUCATZYL, but have not yet generated any revenue from commercial product sales. We have funded our operations to date primarily with proceeds from government grants, sales of our equity securities, through public offerings and pursuant to our at-the-equity market facility, through U.K. research and development tax credits and receipts from the SME and RDEC schemes, out-licensing arrangements and strategic collaboration and financing agreements. From our inception in 2014 through September 30, 2024, we have raised an aggregate of $1.7 billion from these capital sources.

Current wording

We have funded our operations to date primarily with proceeds from government grants, sales of our equity securities, through public offerings and pursuant to our at-the-equity market facility, through United Kingdom research and development tax credits and receipts from the SME and RDEC schemes, out-licensing arrangements and strategic collaboration and financing agreements. From our inception in 2014 through March 31, 2025, we have raised an aggregate of $1.7 billion from these capital sources.

Previous wording

As of September 30, 2024, we had cash and cash equivalents of $657.1 million.

Current wording

As of March 31, 2025, we had cash and cash equivalents of $95.8 million and available-for-sale debt securities of $420.8 million.

Previous wording

During the nine months ended September 30, 2023, operating activities used $120.8 million of cash, resulting from our net loss of $131.2 million, and net cash used resulting from changes in our operating assets and liabilities of $23.5 million, partially offset by non-cash charges of $33.9 million. The non-cash charges related to interest expense including cumulative catch-up adjustments on liabilities related to future royalties and milestones, net of $14.9 million, share-based compensation of $7.9 million, depreciation and amortization of $4.8 million, loss on disposal of property and equipment of $3.8 million, non-cash operating lease expense of $2.9 million, impairment of operating lease right-of-use assets and related property and equipment of $0.4 million and loss on termination of operating lease of $0.1 million, which was offset by deferred income tax movement of $0.5 million and foreign exchange differences of $0.4 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2023 consisted primarily of a $12.0 million decrease in current and non-current operating lease liabilities, a decrease in accrued expenses and other liabilities of $6.8 million, net of operating lease right of use assets, and a net increase of $5.7 million in prepaid expenses and other current and non-current assets, offset by a decrease in long-term deposits of $0.9 million and an increase in accounts payable of $0.1 million.

Current wording

During the three months ended March 31, 2025, operating activities used $75.6 million of cash, resulting from our net loss of $70.2 million and net cash used resulting from changes in our operating assets and liabilities of $17.7 million, partially offset by non-cash charges of $12.3 million. The non-cash charges related to interest expense on liabilities related to future royalties and milestones, net, of $10.1 million, share-based compensation of $2.9 million, depreciation of $2.0 million, non-cash operating lease expense of $1.0 million, deferred income tax of $0.5 million and amortization of $0.3 million, which was offset by accretion on investments of $2.6 million and foreign exchange differences of $1.9 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the three months ended March 31, 2025 consisted primarily of an increase in accounts receivable of $14.3 million, an increase in inventories of $10.1 million and a decrease in accrued expenses and other liabilities of $3.8 million, offset by an increase in deferred revenue of $4.7 million, an increase of $3.2 million in our operating lease liability, an increase in accounts payable of $1.9 million, and a net decrease of $0.7 million in prepaid expenses and other current and non-current assets.

Previous wording

During the nine months ended September 30, 2024, operating activities used $168.3 million of cash, resulting from our net loss of $193.1 million and net cash used resulting from changes in our operating assets and liabilities of $20.7 million, partially offset by non-cash charges of $45.4 million. The non-cash charges related to interest expense including cumulative catch-up adjustments on liabilities related to future royalties and milestones, net of $39.7 million, share-based compensation of $9.2 million, depreciation and amortization of $5.6 million, non-cash operating lease expense of $3.5 million, impairment of operating lease right-of-use assets and related property and equipment of $0.4 million, loss on disposal of property and equipment of $0.2 million and loss on termination of operating lease of $0.2 million, which was offset by foreign exchange differences of $13.1 million and deferred income tax movement of $0.3 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2024 consisted primarily of a net increase of $21.6 million in prepaid expenses and other current and non-current assets and a decrease of $4.1 million in our operating lease liability, offset by an increase in accrued expenses and other liabilities of $3.7 million and an increase in accounts payable of $1.3 million.

Current wording

During the three months ended March 31, 2024, operating activities used $40.5 million of cash, resulting from our net loss of $52.7 million, and net cash used resulting from changes in our operating assets and liabilities of $13.8 million, partially offset by non-cash charges of $26.0 million. The non-cash charges related to interest expense accrued and cumulative catch-up adjustment of $19.3 million, share-based compensation of $2.3 million, depreciation and amortization of $1.8 million, foreign exchange differences of $1.7 million, and non-cash operating lease expense of $1.1 million, which was offset by deferred income tax movement of $0.2 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the three months ended March 31, 2024 consisted primarily of a net increase of $10.1 million in prepaid expenses and other current and non-current assets, a decrease of $1.2 million in our operating lease liability, and an increase in accrued expenses and other liabilities of $3.8 million, offset by an increase in accounts payable of $1.3 million.

Previous wording

Net Cash Provided by (Used in) Financing Activities

Current wording

Net Cash Provided by Financing Activities

Previous wording

During the nine months ended September 30, 2024, net cash provided by financing activities of $559.5 million related to net aggregate proceeds raised from the BioNTech Agreements and our underwritten offering of ADSs. During the nine months ended September 30, 2023, net cash used in financing activities of $0.9 million was primarily for payments of issuance costs relating to a prior equity financing.

Current wording

During the three months ended March 31, 2025, there was no cash provided by financing activities. During the three months ended March 31, 2024, net cash provided by financing activities of $561.4 million related to aggregate proceeds raised from the BioNTech Agreements and our underwritten offering of ADSs.

Previous wording

•hire additional clinical, medical and development personnel;

Current wording

•hire additional manufacturing, clinical, medical and development personnel;

Previous wording

Based on our current clinical development and commercial plans, we believe our current cash and cash equivalents will be sufficient to fund our current and planned operating expenses and capital expenditure requirements for at least the next twelve months from the date of the issuance of these unaudited condensed consolidated financial statements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Current wording

Based on our current clinical development and commercialization plans, we believe our existing cash and cash equivalents of $95.8 million and marketable securities of $420.8 million as of March 31, 2025, will enable us to fund our current and planned operating expenses and capital expenditure requirements for at least twelve months from the issuance of this Quarterly Report. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. If we receive regulatory approval for our other product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.

Previous wording

Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public or private equity offerings, reimbursable U.K. research and development tax credits and receipts from the SME and RDEC schemes, out-licensing agreements, or strategic collaboration agreements. To the extent that we raise additional capital through the sale of equity, the ownership interest of existing shareholders will be diluted. If we raise additional funds through other third-party funding, collaborations agreements, strategic alliances, out-licensing agreements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

Current wording

Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public or private equity offerings, reimbursable United Kingdom research and development tax credits and receipts from the SME and RDEC schemes, out-licensing agreements, or strategic collaboration agreements. To the extent that we raise additional capital through the sale of equity, the ownership interest of existing shareholders will be diluted. If we raise additional funds through other third-party funding, collaborations agreements, strategic alliances, out-licensing agreements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

Previous wording

Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated interim financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed consolidated interim financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Previous wording

As of September 30, 2024, other than disclosed within Notes 12 to 14 to our unaudited condensed consolidated financial statements included in this report, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report.

Current wording

As of March 31, 2025, other than disclosed in Notes 15 to 16 to our unaudited condensed consolidated interim financial statements included in this report, there have been no material changes to our contractual obligations and commitments from those described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report.

Previous wording

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies,” to our unaudited condensed consolidated financial statements included in in this Quarterly Report.

Current wording

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies,” to our unaudited condensed consolidated interim financial statements included in this Quarterly Report.