Autolus Therapeutics plc

Previous wording

We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars, and we prepare our consolidated financial statements in accordance with U.S. GAAP, as issued by the FASB. All references in this Quarterly Report on Form 10-Q to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed consolidated statements of operations and comprehensive loss and unaudited condensed consolidated statements of cash flows for the three months ended 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.

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 June 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3355 and £1.00 to $1.2616, respectively. Our unaudited condensed consolidated statements of operations and comprehensive loss and cash flows for the six months ended June 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2971 and £1.00 to $1.2648, respectively. Our unaudited condensed consolidated balance sheet as of June 30, 2025 and audited consolidated balance sheet as of December 31, 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3713 and £1.00 to $1.2535, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at those or any other exchange rate as of those or any other dates.

Previous 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.

Current wording

Since our inception, we have incurred significant operating losses. For the three months ended June 30, 2025 and 2024, we incurred net losses of $47.9 million and $58.3 million, respectively, and had an accumulated deficit of $1,217.3 million and $1,099.2 million as of June 30, 2025 and December 31, 2024, respectively.

Previous 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.

Current wording

As of June 30, 2025, we had cash and cash equivalents of $123.8 million and marketable securities of $330.5 million. Based on our current clinical development and commercialization plans, we believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this Quarterly Report. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our product candidates, management may need to curtail its development efforts and planned operations.

Previous wording

•Our reported Q1 2025 net product sales of $9.0 million.

Current wording

•We reported Q2 2025 net product sales of $20.9 million.

Previous wording

•We have 39 cancer treatment centers fully activated in the United States as of May 7, 2025. Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total United States medical lives.

Current wording

•We have 46 cancer treatment centers fully activated in the United States as of August 12, 2025. Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total United States medical lives.

Previous wording

•On April 25, 2025, the MHRA granted conditional marketing authorization for AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lmphoblastic leukemia (“r/r B-ALL”). We will work with The National Institute for Health and Care Excellence (“NICE”) on patient access to therapy and a meeting is planned in May 2025.

Current wording

•On April 25, 2025, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) granted conditional marketing authorization for AUCATZYL for the treatment of adult patients age 18+ with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“r/r B-ALL”). Following an initial review and in line with prior practice for CAR-T therapies, the National Institute for Health and Care Excellence (“NICE”) issued a preliminary Appraisal Consultation Decision (“ACD”) recommending against funding for AUCATZYL. We plan to respond to NICE’s questions and will continue to work towards a pathway for patient access to therapy in the United Kingdom.

Previous wording

•Preliminary data from the Phase 1 dose confirmation clinical trial (“CARLYSLE”) in refractory systemic lupus erythematosus (“SLE”) patients were reported on April 23, 2025, and support progressing into a planned Phase 2 pivotal clinical trial. Out of six patients in the cohort, three patients had complete renal response, all by month three. Complement normalized in all patients by month one. Rash, alopecia and mucosal ulcers resolved by month three and arthritis resolved by month one in all patients. Data show high peak expansion and deep B cell aplasia consistent with known obe-cel characteristics in oncology indications. No dose limiting toxicities (“DLTs”) or immune effector cell-associated neurotoxicity syndrome (“ICANS”) were observed in the trial to date. Grade one cytokine release syndrome (“CRS”) was observed in three out of six patients. Hypertension, a typical sign of advanced lupus nephritis, pre-existed in three patients. On study, five of six patients experienced a transient hypertension, including Grade 3, well managed by anti-hypertensive agents.

Current wording

•Preliminary data from the Phase 1 dose confirmation clinical trial (“CARLYSLE”) in refractory systemic lupus erythematosus (“SLE”) patients were reported on April 23, 2025, and support progressing into a planned Phase 2 pivotal study.

Previous wording

•We have aligned with U.S. Food and Drug Administration (the “FDA”) on the Phase 2 trial design and potential registrational path to approval and anticipates dosing the first patient in a Phase 2 trial before the year ending December 31, 2025.

Current wording

•The Company has aligned with the U.S. Food and Drug Administration (the “FDA”) on the Phase 2 trial design and potential registrational path to approval and continues to anticipate dosing the first patient in a Phase 2 clinical trial before the end of 2025.

Previous wording

•Full data with longer term follow-up from the Phase 1 CARLYSLE clinical trial is targeted for presentation at a medical conference in the second half of 2025.

Current wording

•Data with longer term follow-up from the Phase 1 CARLYSLE clinical trial is targeted for presentation at a medical conference in the second half of 2025.

Previous wording

•We plan to advance obe-cel into clinical development in progressive MS. We expect to dose our first patient in a Phase 1 dose escalation clinical trial by year-end 2025.

Current wording

•We plan to advance obe-cel into clinical development in progressive MS. We continue to expect to dose our first patient in a Phase 1 dose escalation clinical trial by year-end 2025.

Previous wording

•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. We are working with the treatment centers on implementing the coding and payment policy from CMS and we are assessing any potential impact on the timing revenue recognition.

Current wording

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, we recognize 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.

Previous wording

We account for our product revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). We have one performance obligation which is satisfied upon the notification by the customer of administration of treatment. However, the performance obligation is constrained by the customer's right of return and/or credit eligibility which expires when a patient is dosed.. Therefore, we recognize revenue from product sales when the customers’ ability to either cancel the order or request a refund has ceased, which is when the product is administered to the patient. Product revenues, net of gross-to-net deductions, are recognized only to the extent that a significant reversal in the amount of cumulative product revenue recognized is not probable of occurring when the uncertainty associated with gross-to- net deductions is subsequently resolved. Product revenues are 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 occur.

Current wording

Product revenue, net of gross-to-net deductions, are 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 revenues are 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 occur.

Previous wording

Travel, lodging, and meal assistance represents financial assistance to qualified patients and their caregiver, reimbursing them for certain travel, lodging, and meal expenses required during their treatment. Accrual for these expenses is based on an estimate of qualified patients that we expect to receive this assistance at each reporting period.

Current wording

Travel, lodging, and meal assistance represents financial assistance to qualified patients and their caregiver, reimbursing them for certain travel, lodging, and meal expenses required during their treatment. We expense the actual expenses made during the period and accrue the estimated unreported or unrecorded expenses at period end.

Previous wording

U.S. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinate. We consider all relevant factors.

Current wording

U.S. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinative. We consider all relevant factors.

Previous wording

Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch raw materials inventory is depleted. Thus, the cost of sales as a percentage of net sales of AUCATZYL for the three months ended March 31, 2025 was affected by use of the initial pre-launch raw materials inventory, which was previously expensed as research and development expense, and is referred to as zero cost inventories. We estimate our cost of sales as a percentage of net product revenue and will continue to be positively impacted as we sell product which includes some raw material inventory that was previously expensed prior to FDA approval.

Current wording

Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch raw materials inventory is depleted. Thus, the cost of sales as a percentage of net sales of AUCATZYL for the three and six months ended June 30, 2025 was affected by use of the initial pre-launch raw materials inventory, which was previously expensed as research and development expense, and is referred to as zero cost inventories. We estimate our cost of sales as a percentage of net product revenue and will continue to be positively impacted as we sell product which includes some raw material inventory that was previously expensed prior to the FDA approval.

Previous wording

Selling, general and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and other administrative functions. Selling, general and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, accounting and audit services. Included in 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 selling, general and administrative expenses is historical irrecoverable input VAT previously claimed on selling, general and administrative expenses and subsequently reversed.

Previous wording

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support the planned development of our product candidates. We anticipate an increase in salaries and related benefits as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of AUCATZYLand our other product candidates.

Current wording

We anticipate that our selling, general and administrative expenses will increase in the future as we increase our headcount to support the planned development of our product candidates. We anticipate an increase in salaries and related benefits as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of AUCATZYLand our other product candidates.

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 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.

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 the applicable SEC and Nasdaq requirements.

Previous wording

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

Current wording

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

Previous 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.

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. Adjustments to increase or decrease the carrying amount are recognized as an adjustment to interest expense, net in the period in which the change in estimate occurred.

Previous wording

Un-surrendered United Kingdom losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $545.6 million at December 31, 2024. A valuation allowance has been recognized against our deferred tax asset relating to our United Kingdom losses. We carried a $2.8 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.

Current wording

Un-surrendered United Kingdom losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $545.6 million at December 31, 2024. A valuation allowance has been recognized against our deferred tax asset relating to our United Kingdom losses. We carried a $2.4 million deferred tax asset balance related to the United States entity at June 30, 2025 for which a valuation allowance of $1.8 million was applied. At June 30, 2025, we recorded a full valuation allowance against the net deferred tax asset in the United Kingdom, as the recoverability due to future taxable profits was uncertain.

Previous wording

During the three months ended March 31, 2025, we generated product revenue, net in the amount of $9.0 million, from the sale of AUCATZYL in the United States, We did not generate any product revenue, in the three months ended March 31, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024.

Current wording

During the three months ended June 30, 2025, we generated product revenue, net in the amount of $20.9 million, from the sales of AUCATZYL in the United States. We did not generate any product revenue in the three months ended June 30, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024.

Previous wording

In the three months ended March 31, 2025, we recognized cost of sales of $18.0 million, primarily consisting of salaries and other employment related costs, including share-based compensation expense, for personnel involved in AUCATZYL manufacturing activities, as well as outsourced professional services. These costs also included direct production costs for commercial product manufacturing and allocated facility costs such as maintenance, depreciation, utilities and rent. We did not recognize any cost of sales in the three months ended March 31, 2024, as AUCATZYL was not approved by the FDA for commercial use until November 8, 2024.

Current wording

In the three months ended June 30, 2025, we recognized cost of sales of $24.4 million, primarily consisting of salaries and other employment related costs, including share-based compensation expense, for personnel involved in AUCATZYL manufacturing activities, as well as outsourced professional services. These costs also included direct production costs for commercial product manufacturing and allocated facility costs such as maintenance, depreciation, utilities and lease expenses. We did not recognize any cost of sales in the three months ended June 30, 2024, as AUCATZYL was not approved by the FDA for commercial use until November 8, 2024.

Previous wording

Certain manufacturing expenses incurred prior to AUCATZYL receiving the FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the three months ended March 31, 2025, would have increased by approximately $2.4 million.

Current wording

Certain manufacturing expenses incurred prior to AUCATZYL receiving FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the three months ended June 30, 2025, would have increased by approximately $1.9 million.

Previous wording

Research and development expenses decreased by $3.9 million to $26.8 million for the three months ended March 31, 2025 from $30.7 million for the three months ended March 31, 2024 primarily due to:

Current wording

Research and development expenses decreased by $9.2 million to $27.4 million for the three months ended June 30, 2025 from $36.6 million for the three months ended June 30, 2024 primarily due to:

Previous wording

•an increase of $7.9 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities;

Current wording

•an increase of $5.8 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in selling, general and administrative activities;

Previous 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.

Current wording

•an increase of $2.4 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations including increase in space utilized for these activities; and

Previous 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

Current wording

•an increase of $0.2 million in commercial readiness costs including legal and professional fees due to increased commercial readiness activities being undertaken.

Previous 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.

Current wording

Interest income decreased to $5.2 million for the three months ended June 30, 2025, as compared to $9.6 million for the three months ended June 30, 2024. The decrease in interest income of $4.4 million was primarily driven by lower aggregate balances and yield associated with our cash, cash equivalents and marketable securities during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024.

Previous 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.

Current wording

There was no license revenue recognized for the six months ended June 30, 2025. License revenue amounting to $10.1 million for the six months ended June 30, 2024 was related to license revenue recognized pursuant to the License and Option Agreement with BioNTech.

Previous wording

•a decrease of $6.1 million related to our information technology infrastructure and support for information systems related to an allocation of expense from research and development to cost of sales and inventories related to commercial manufacturing following FDA approval of AUCATZYL in November 2024; and

Current wording

•a decrease of $14.0 million related to our information technology infrastructure and support for information systems related to an allocation of expense from research and development to cost of sales and inventories related to commercial manufacturing following FDA approval of AUCATZYL in November 2024; and

Previous wording

•a decrease of $2.0 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by the reallocation of employees to commercial manufacturing activities included in cost of sales and inventories; offset by:

Current wording

•a decrease of $4.4 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by the reallocation of employees to commercial manufacturing activities included in cost of sales and inventories; offset by:

Previous 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.

Current wording

•a decrease of $3.9 million in United Kingdom R&D tax credits (increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, and lower qualifying spend; and

Previous wording

•an increase of $3.1 million in clinical trial costs, clinical manufacturing costs and material transportation costs relating to research and development activities; and

Current wording

•an increase of $1.4 million in clinical trial costs, clinical manufacturing costs, material transportation costs and utilization of raw materials and consumables relating to research and development activities.

Previous wording

Foreign exchange gains (losses), net increased to a gain of $1.2 million for the three months ended March 31, 2025 from a loss of $1.3 million for the three months ended March 31, 2024. The gains and losses rises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents and liabilities related to future royalties and milestones.

Current wording

Foreign exchange gains (losses), net increased to a gain of $2.7 million for the six months ended June 30, 2025 from a loss of $0.5 million for the six months ended June 30, 2024. The gains and losses rises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents and liabilities related to future royalties and milestones.

Previous 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.

Current wording

Interest expense, net decreased to $3.3 million for the six months ended June 30, 2025 as compared to $29.4 million for the six months ended June 30, 2024. Interest expense, net decreased by $26.1 million primarily due to cumulative catch up adjustments as a result of changes in the assumptions used in the valuation of the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement for the six months ended June 30, 2025 compared to the six months ended June 30, 2024.

Previous wording

As of May 8, 2025, we have one product approved for commercial sale in the United States, AUCATZYL, with the first commercial sale occurring in January 2025. Although we have recorded product revenue for sales of AUCATZYL, we have continued to incur operating losses and generate cumulative negative cash flows from our operations since our inception. We have an accumulated deficit of $1,169.4 million as of March 31, 2025.

Current wording

As of the date of this Quarterly Report, we have one product, AUCATZYL, approved for commercial sale in the United States, United Kingdom, and the EU, with the first commercial sale occurring in the United States in January 2025. We have not yet begun sales of AUCATZYL in the United Kingdom or the EU. Although we have recorded product revenue for sales of AUCATZYL, we have continued to incur operating losses and generate cumulative negative cash flows from our operations since our inception. We have an accumulated deficit of $1,217.3 million as of June 30, 2025.

Previous 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.

Current wording

We expect to incur significant expenses and operating losses for the foreseeable future as we market and continue commercialization of 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 for which we may obtain regulatory approval.

Previous 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.

Current wording

We have funded our operations to date primarily with proceeds from product revenue, 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 June 30, 2025, we have generated an aggregate of $1.7 billion from these capital sources.

Previous 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.

Current wording

As of June 30, 2025, we had cash and cash equivalents of $123.8 million and available-for-sale debt securities of $330.5 million.