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Autolus Therapeutics plc

For the period ended Mar 31, 2026. Filed May 14, 2026.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 14, 2026

AUTL$1.28+1.6%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-12.

0001730463-25-000088

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-14.

0001730463-26-000065

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 199 previous paragraphs and 157 current paragraphs.

76 unchanged; 43 reworded; 36 added; 73 removed; 7 previous and 2 current paragraphs rearranged.

Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (36)

Current report

•We reported net product revenue, net of $26.2 million for three months ended March 31, 2026, compared to $9.0 milion for the three months ended March 31, 2025.

Current report

•We launched AUCATZYL in the U.K. in January 2026 and it is now available under routine commissioning.

Current report

•The Phase 2 portion of the ongoing CATULUS Phase 1 trial of obe-cel in pediatric relapsed or refractory (r/r) B-ALL patients is underway and we expect to report data at the end of 2027. The U.S. Food and Drug Administration (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL.

Current report

•Data from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (“srSLE”) supported progression of obe-cel as a treatment for LN and selection of the recommended Phase 2 dose of 50 million cells. Following alignment with the FDA on a potential registrational path to approval, the pivotal LUMINA Phase 2 trial is enrolling, and we expect to report data in 2028.

Current report

▪The first patient was dosed in the ongoing Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis, and initial data is expected to be reported at the end of 2026.

Current report

•In April 2026, we announced a strategic initiative and plan to improve operational efficiency and reduce operating expenses. As part of this plan, we are implementing a reduction in force affecting approximately 13% of its existing overall workforce, impacting all areas of the business. The actions are expected to reduce operating expenses by approximately $15 million on an annualized basis beginning in 2027. As a result of the reorganization, which includes employee-related actions taken beginning in the second half of 2025, we expect to incur total restructuring charges of approximately $8 million, consisting primarily of employee severance and related costs, the majority of which will be recognized in the first half of 2026. The implementation of the workforce reduction plan is expected to be complete by the third quarter of 2026.

Current report

During the three-month period ended March 31, 2025, our product revenue comprised of sales of AUCATZYL in the U.S. In the U.S., we use Cardinal Health as an agent to deliver our product, AUCATZYL, to ATCs. The ATCs are responsible for the treatment of the patient including administration of the product which occurs in two separate doses. Cardinal Health is obligated to pay us for the product upon the delivery and acceptance of the product at the ATC within standard payment terms. The ATC is obligated to pay Cardinal Health for the product upon receipt and acceptance of the product and is entitled to a credit, in certain circumstances, including when the patient is not administered one or both doses. In November 2025, the NICE recommended AUCATZYL for use in the NHS in England and Wales as a treatment option for adult patients (age 26 and older) with r/r B-ALL. The first sale of AUCATZYL in the United Kingdom occurred in January 2026.

Current report

During the three-months ended March 31, 2026, we launched AUCATZYL in the U.K. Consequently, our product revenue, net comprised of sales of AUCATZYL in the U.S. and U.K. AUCATZYL is available in the U.K. through the NHS and private treatment centers.

Current report

We have determined that the patient is the customer pursuant to ASC 606 in the arrangement. We have identified a single performance obligation which is satisfied when the patient has received its final dose of the product. We record an accounts receivable on the balance sheet when product sales are invoiced and the final dose of the product has been administered to the patient.

Current report

We began recognizing product revenue, net arising from the commercial sales of AUCATZYL in the United States and United Kingdom in January 2025 and January 2026, respectively. Product revenue, net increased by $17.2 million to $26.2 million for the three months ended March 31, 2026 from $9.0 million for the three months ended March 31, 2025. The increase is primarily due to an increase in the number of AUCATZYL doses administered in the territories where we commercialize AUCATZYL.

Current report

Cost of sales increased by $6.6 million to $24.6 million for the three months ended March 31, 2026 from $18.0 million for the three months ended March 31, 2025 primarily due to:

Current report

•an increase of $6.7 million in the consumption of raw materials and consumables relating to the manufacturing of AUCATZYL; and

Current report

•a net increase of $0.7 million in information technology infrastructure and support for information systems, facility costs and lease expenses relating to the manufacturing and production of AUCATZYL; offset by

Current report

•a decrease of $0.5 million in salaries and other employment related costs including share-based compensation expenses; and

Current report

•a decrease of $0.3 million in legal and professional fees related to manufacturing activities.

Current report

Research and development expenses, net decreased by $5.5 million to $21.2 million for the three months ended March 31, 2026 from $26.7 million for the three months ended March 31, 2025 primarily due to:

Current report

•a decrease of $5.2 million in clinical trial costs, clinical manufacturing supply costs and related support costs; and

Current report

Selling, general and administrative expenses increased by $10.4 million to $39.9 million for the three months ended March 31, 2026 from $29.5 million for the three months ended March 31, 2025 primarily due to:

Current report

•an increase of $1.6 million in professional fees primarily related to commercialization activities in the U.S. and U.K.; and

Current report

We have one product approved for commercial sale in the United States and United Kingdom, AUCATZYL, of which the first commercial sale of AUCATZYL in the United States and United Kingdom was made during January 2025 and January 2026, respectively. We have funded our operations to date primarily with proceeds from government grants, sales of our equity securities including ADSs, through public offerings and pursuant to our at-the-market equity facility, through U.K. research and development tax credits and receipts from the SME and RDEC schemes, out-licensing arrangements, strategic collaboration agreements and sale of our commercial product. We have an accumulated deficit of $1,458.4 million as of March 31, 2026.

Current report

Net cash used in our operating activities was $65.3 million for the three months ended March 31, 2026, compared to net cash used in operating activities of $75.6 million for the three months ended March 31, 2025. The decrease of $10.3 million in net cash used in our operating activities was primarily driven by increases in accounts receivable, inventories net, operating lease liability and prepaid expenses working capital movements, reflecting the timing of payments, partially offset by accounts payable and accrued expenses working capital movements.

Current report

•initiate new preclinical activities and clinical trials for our product candidates;
Removed paragraphs (73)

Previous report

•We reported net product revenue, net of $21.1 milion for three months ended September 30, 2025 and deferred revenue of $7.6 milion as of September 30, 2025.

Previous report

•We have 60 cancer treatment centers fully activated in the United States of November 12, 2025, achieving the target of 60 activated centers prior to year-end.

Previous report

•Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total United States medical lives.

Previous report

•The United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”) granted AUCATZYL conditional marketing authorization in April 2025, and Autolus has since engaged with the National Institute for Health and Care Excellence (“NICE”) to obtain its recommendation for reimbursement of AUCATZYL by the National Health Service (“NHS”). Such discussions are ongoing and Autolus anticipates commercial launch in the United Kingdom, provided these discussions result in an appropriate level of reimbursement for AUCATZYL for an appropriate patient population.

Previous report

•Data from the ongoing Phase Ib/II CATULUS study evaluating the safety and efficacy of obe-cel in patients under 18 years with CD19-positive r/r B-ALL or B-cell Non-Hodgkin Lymphoma (“NHL”) will be presented at the American Society of Hematology Annual Meeting (“ASH”). Data show the safety profile of obe-cel in pediatric patients is consistent with that previously reported in adults, with low rates of high-grade cytokine release syndrome (“CRS”) and immune effector cell-associated neurotoxicity syndrome (“ICANS”). Overall response rate (“ORR”) was high at 95% and nearly 90% of responders had ongoing remission at data cut-off. Additional data will be presented in a poster presentation at ASH on December 7, 2025.

Previous report

•In October 2025, the FDA granted regenerative medicine advanced therapy (“RMAT”) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL. The RMAT designation is a program created under the 21st Century Cures Act to accelerate development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.

Previous report

•We presented data from the Phase 1 CARLYSLE clinical trial on October 28, 2025 at the American College of Rheumatology (“ACR”) Convergence 2025. Data in severe refractory systemic lupus erythematosus (“srSLE”)) suggests obe-cel is well tolerated with no ICANS or high-grade CRS. Preliminary efficacy data demonstrate achievement of definition of remission in SLE (“DORIS”) in 83% (n=5/6) of patients and complete renal response in 50% (n=3/6) of patients. All responses and remissions are ongoing with no evidence of disease activity at a median follow up of 8.9 months (range 6-13.8 months).

Previous report

•Additional findings from the ongoing CARLYSLE study will be presented in an oral presentation at the American Society of Hematology Annual Meeting 2025 in December 2025. The B-cell reconstitution profiles data suggest that obe-cel may induce a reset of pathologic autoimmunity. Updated Phase I data with longer follow-up, and data in patients who received 100×106 CAR T-cells will be presented.

Previous report

•We have previously aligned with the FDA on the Phase 2 trial design and potential registrational path to approval for obe-cel in LN. Data to date supported progressing into the Phase 2 LUMINA trial. The first patient is expected to be dosed prior to December 31, 2025.

Previous report

We account for our revenues pursuant to the provisions of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). We have 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. We recognize 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.

Previous report

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 report

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 our products through our third-party logistics partner at a discount. Our third party logistics partner then charges the discount back to us.

Previous report

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. We assess and updates our estimates each reporting period to reflect actual claims and other current information.

Previous report

Our Company's wholly-owned subsidiary in the United States also participates in programs with government entities, the most significant of which are the covered entities under the 340B Drug Pricing Program (the “340B Program”), the US. Department of Defense (the “DoD”), and the US. Department of Veterans Affairs (the “VA”), whereby pricing on products is extended below list price to participating entities. These entities purchase products at the lower program price then charge the Company the difference between their acquisition cost and the lower program price. Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale.

Previous report

Our Company's wholly-owned subsidiary in the United States further participates in state government Medicaid programs and the TriCare program. All discounts and rebates provided through these programs are included in the Company's Medicaid and TriCare rebate accrual. The estimated amount of unpaid or unbilled rebates are to be recognized and presented as a liability.

Previous report

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 report

Co-pay assistance represents financial assistance to qualified patients, assisting them with cost sharing obligations for our product based on benefit design structure required by insurance. Our accrual for copay is based on an estimate of claims and the cost per claim that we expect to receive associated with qualified patients that exist at each reporting period.

Previous report

We account for our revenue pursuant to the provisions of ASC 606. As of September 30, 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 report

In determining the appropriate amount of revenue to be recognized in relation to each license agreement, we perform the following steps: (i) identify the promised goods or services in the contract; (ii) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measure of the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations based on estimated selling prices; and (v) recognize of revenue when (or as) we satisfy each performance obligation.

Previous report

If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, upfront fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. We evaluate the measure of progress at each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

Previous report

Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, we consider the nature of service that we promise to transfer to the customer. When we decide on a method of measurement, we will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances.

Previous report

If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options that are not determined to be material rights are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. We evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. We allocate the transaction price to material rights based on the relative standalone selling price, which is determined based on any identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.

Previous report

ASC 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example.

Previous report

If the consideration in a contract includes a variable amount, we will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if our entitlement to the consideration is contingent on the occurrence or non-occurrence of a future event. We consider contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period.

Previous report

We assess whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.

Previous report

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 report

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Previous report

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 report

During the three months ended September 30, 2025, we generated product revenue, net in the amount of $21.1 million, from the sales of AUCATZYL in the United States. We did not generate any product revenue in the three months ended September 30, 2024, as AUCATZYL was approved by the FDA for commercial use on November 8, 2024.

Previous report

In the three months ended September 30, 2025, we recognized cost of sales of $28.6 million, primarily consisting of salaries and other employment related costs, including share-based compensation expense, for personnel involved in AUCATZYL manufacturing activities, as well as outsourced professional services. These costs also included direct production costs for commercial product manufacturing and allocated facility costs such as maintenance, depreciation, utilities and lease expenses. Inventory reserves and write-offs recognized in cost of sales for the three and nine months ended September 30, 2025 amounted to $4.3 million and $7.6 million, respectively, reflecting estimated obsolescence and lower market values. We did not recognize any cost of sales in the three months ended September 30, 2024, as AUCATZYL was not approved by the FDA for commercial use until November 8, 2024.

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Reworded paragraphs (43)

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 September 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3482 and £1.00 to $1.3008, respectively. Our unaudited condensed consolidated statements of operations and comprehensive loss and cash flows for the nine months ended September 30, 2025 and 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3141 and £1.00 to $1.2768, respectively. Our unaudited condensed consolidated balance sheet as of September 30, 2025 and audited consolidated balance sheet as of December 31, 2024 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3441 and £1.00 to $1.2535, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at those or any other exchange rate as of those or any other dates.

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, 2026 and 2025 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3477 and £1.00 to $1.2588, respectively. Our unaudited condensed consolidated balance sheet as of March 31, 2026 and audited consolidated balance sheet as of December 31, 2025 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3216 and £1.00 to $1.2935, 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

We are an early commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using our broad suite of proprietary and modular T cell programming technologies, we are 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. We believe our 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.

Current wording

We are a commercial-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using our broad suite of proprietary and modular T cell programming technologies, we are 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. We believe our 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.

Previous wording

Since our inception, we have incurred significant operating losses. For the three months ended September 30, 2025 and 2024, we incurred net losses of $79.1 million and $82.1 million, respectively, and had an accumulated deficit of $1,296.4 million and $1,099.2 million as of September 30, 2025 and December 31, 2024, respectively.

Current wording

Since our inception, we have incurred significant operating losses. For the three months ended March 31, 2026 and 2025, we incurred net losses of $71.6 million and $70.2 million, respectively, and had an accumulated deficit of $1,458.4 million and $1,386.8 million as of March 31, 2026 and December 31, 2025, respectively.

Previous wording

As of September 30, 2025, we had cash and cash equivalents of $86.1 million and marketable securities of $281.3 million. Based on our current clinical development and commercialization plans, we believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this Quarterly Report. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our product candidates, management may need to curtail its development efforts and planned operations.

Current wording

As of March 31, 2026, we had cash and cash equivalents of $130.9 million and marketable securities of $98.5 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

•Data from the Real-World Outcomes Collaborative for CAR T in Adult ALL database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL (obecabtagene autoleucel) and TECARTUS (brexucabtagene autoleucel) for relapsed acute lymphoblastic leukemia with r/r ALL will be presented at the American Society of Hematology Annual Meeting.

Current wording

•Data from the Real-World Outcomes Collaborative for CAR T in Adult ALL (“ROCCA”) consortium database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL was presented at the TANDEM meeting in February 2026. Real-world data show consistency in both safety and efficacy compared to the FELIX clinical trial that was the basis for regulatory approvals. The ROCCA Consortium registry covered approximately 60% of U.S. commercial patients at a data cutoff of January 2026.

Previous wording

•We plan to advance obe-cel into initial clinical development in progressive multiple sclerosis (“MS”). The first patient in the Phase 1 BOBCAT trial was dosed in October 2025. The BOBCAT trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. The primary endpoint is to assess safety and tolerability of obe-cel. Key secondary endpoints include evaluating the preliminary efficacy of obe-cel using change from baseline in standard efficacy measures.

Current wording

•We have advanced obe-cel into initial clinical development to explore treatment in progressive MS. The Phase 1 BOBCAT trial, expected to include up to 18 adult patients, is enrolling and will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS. We expect to report initial data from the trial at the end of 2026 and full data in 2027.

Previous wording

•In November 2025, Moderna announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, an investigational mRNA-based T-cell engager for participants with relapsed or refractory multiple myeloma. mRNA-2808 utilizes Autolus’ proprietary binder that was licensed to Moderna in 2022.

Current wording

•In November 2025, Moderna announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, an investigational mRNA-based T-cell engager for participants with relapsed or refractory multiple myeloma. mRNA-2808 utilizes our proprietary binder that was licensed to Moderna in 2022.

Previous wording

•In July 2025, the European Commission granted marketing authorization for AUCATZYL in adult patients (age 26 and older) with r/r B-ALL. Evaluation of potential pricing and feasibility of market entry opportunities in certain EU countries is ongoing; however, at this time, launch in Germany is on hold and we do not anticipate any EU sales of AUCATZYL in 2025 and 2026.

Current wording

In July 2025, the European Commission granted marketing authorization for AUCATZYL in adult patients (age 26 and older) with r/r B-ALL. Evaluation of potential pricing and the feasibility of market entry opportunities in certain EU countries is ongoing; consequently, the commercial launch in Germany is currently on hold. We did not generate any EU product revenue from AUCATZYL in 2025 and do not anticipate any EU product revenue in 2026.

Previous 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.

Current wording

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. Refer to Note 2, “Summary of Significant Accounting Policies,” for further details on our product revenue, net accounting policy.

Previous wording

Cost of sales represents production costs including raw materials, employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in commercial manufacturing functions, external manufacturing costs including outsourced professional expenses services, allocated facilities costs, depreciation and other expenses, royalties payable to third-parties and other costs incurred in bringing inventories to their location and condition prior to sale. Cost of sales also includes the cost of all commercial product delivered to authorized treatment centers, including product delivered but not yet recognized as revenue, which is captured as deferred revenue, any cancelled orders, and product related to the patient access program. Cost of sales may also include costs related to excess or obsolete inventory adjustment charges and amortization expense of intangible assets.

Current wording

Cost of sales represents production costs including raw materials, employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in commercial manufacturing functions, external manufacturing costs including outsourced professional expenses services, allocated facilities costs, depreciation and other expenses, royalties payable to third-parties and other costs incurred in bringing inventories to their location and condition prior to sale. Cost of sales also includes the cost of all commercial product which is recognized as cost of goods sold upon final administration to the patient, any cancelled orders, and product related to the patient access program. Cost of sales may also include costs related to excess or obsolete inventory adjustment charges and amortization expense of intangible assets.

Previous wording

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

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 months ended March 31, 2026 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 cost of sales as a percentage of net product revenue and will continue to be positively impacted as we sell products which includes some raw material inventory that was previously expensed prior to the FDA approval.

Previous wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next few years as we increase personnel costs, initiate and conduct additional clinical trials and prepare regulatory filings related to our product candidates. We also expect to incur additional expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license agreements to acquire the rights related to our product candidates.

Current wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next few years as we initiate and conduct additional clinical trials and prepare regulatory filings related to our product candidates. We also expect to incur additional expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license agreements to acquire the rights related to our product candidates.

Previous wording

Research and development expenditure is presented net of reimbursements from reimbursable tax and expenditure credits from the United Kingdom government. As a company that carries out extensive research and development activities, we benefit from the Research and Development tax incentives provided by United Kingdom tax legislation. The specific provisions available to claim under vary year on year dependent on the criteria met.

Current wording

Research and development expenditure is presented net of reimbursements from reimbursable tax and expenditure credits from the United Kingdom government. As a company that carries out extensive research and development activities, we benefit from the Research and Development tax incentives provided by United Kingdom tax legislation. The specific tax incentives available for us to claim vary year to year and are dependent on the criteria met.

Previous wording

The SME program has been particularly beneficial to us as under such program the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreased to 18.6% after April 1, 2023. The United Kingdom government enacted changes to the SME regime effective from April 1, 2023 which included the introduction of a new rate for R&D intensive companies of 27%. Qualifying expenditures largely comprise of employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income. A large proportion of costs relate to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.

Current wording

The SME program has been particularly beneficial to us as under such program the tax losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 33.35% of qualifying expenditure incurred prior to April 1, 2023 and decreased to 18.6% after April 1, 2023. The United Kingdom government enacted changes to the SME regime effective from April 1, 2023 which included the introduction of a new rate for R&D intensive companies of 27%. Qualifying expenditures largely comprise of employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income. A large proportion of costs relate to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.

Previous wording

In the accounting period ending December 31, 2025, we will not qualify for relief under the SME program, based on size criteria concerning employee headcount, turnover and gross assets. However, we may make a claim under the merged RDEC regime, as detailed above.

Current wording

In the accounting period ended March 31, 2026, we may make a claim under the merged RDEC regime, as detailed above.

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, termination benefits and related charges and audit services. Included in selling, general and administrative expenses is historical irrecoverable input VAT previously claimed on selling, general and administrative expenses and subsequently reversed.

Current wording

Selling, general and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and other administrative functions. Selling, general and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, accounting, termination benefits and related charges, audit services, gains and losses on disposal of property and equipment and impairment of operating lease right of use assets and related property and equipment. 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 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.

Current wording

We anticipate that our selling, general and administrative expenses will increase in the future as we maintain the headcount necessary to support the commercialization of AUCATZYL and the planned development of our product candidates. We anticipate an increase in salaries and related benefits as a result of our commercial operations, especially as they relate to the sales and marketing of AUCATZYL and our other product candidates. In addition, we anticipate an increase in termination benefits and related charges arising from the reduction in force approved and announced in April 2026, with a significant portion of these termination benefits and related charges expected to be recognized in the first half of 2026.

Previous wording

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

Previous wording

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

Current wording

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

Previous wording

Un-surrendered United Kingdom losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $545.6 million at December 31, 2024. A valuation allowance has been recognized against our deferred tax asset relating to our United Kingdom losses. We carried a $2.4 million deferred tax asset balance related to the United States entity at September 30, 2025 for which a valuation allowance of $1.7 million was applied. At September 30, 2025, we recorded a full valuation allowance against the net deferred tax asset in the United Kingdom, as the recoverability due to future taxable profits was uncertain.

Current 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 United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $953.6 million at December 31, 2025. No deferred tax assets are recognized on our U.K. losses and tax credit carryforwards because there is currently no indication that we will make sufficient taxable profits to utilize these tax losses and tax credit carryforwards. We carry a $3.6 million deferred tax asset balance related to the U.S. entity at March 31, 2026 for which a valuation allowance of $2.4 million was applied. We have recorded a valuation allowance against the net deferred tax asset where the recoverability due to future taxable profits is unknown. 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).

Previous 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%.

Current wording

In the event we generate profits 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%.

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 September 30, 2025, would have increased by approximately $2.3 million.

Current wording

Certain manufacturing expenses incurred prior to AUCATZYL receiving the FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included would have increased by approximately $0.7 million and $2.4 million for the three months ended March 31, 2026 and 2025 respectively.

Previous wording

•a decrease of $2.6 million in clinical trial costs, clinical manufacturing costs, material transportation costs and utilization of raw materials and consumables relating to research and development activities; offset by:

Current wording

•a decrease of $0.7 million in salaries and other employment related costs including share-based compensation expense relating to research and development activities; offset by:

Previous wording

•a decrease of $2.7 million in United Kingdom R&D tax credits (resulting in an increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, as well as lower qualifying spend.

Current wording

•a decrease of $0.4 million in United Kingdom R&D tax credits (resulting in an increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, as well as lower qualifying spend.

Previous wording

•an increase of $4.8 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in selling, general and administrative activities;

Current wording

•an increase of $7.3 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 $1.4 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.

Current wording

•an increase of $1.5 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations, including increase in space utilized for these activities.

Previous wording

Foreign exchange losses, net decreased to $0.9 million for the three months ended September 30, 2025 as compared to $11.9 million for the three months ended September 30, 2024 primarily due to gains and losses on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, as well as our cash and cash equivalents and liabilities related to future royalties and milestones.

Current wording

Foreign exchange (losses) gains, net decreased to a loss of $2.7 million for the three months ended March 31, 2026 as compared to a gain of $1.2 million for the three months ended March 31, 2025 primarily due to gains and losses on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, as well as our cash and cash equivalents and liabilities related to future royalties and milestones.

Previous wording

Interest income decreased to $4.4 million for the three months ended September 30, 2025, as compared to $8.3 million for the three months ended September 30, 2024. The decrease in interest income of $3.9 million was primarily driven by lower aggregate balances and yield associated with our cash, cash equivalents and marketable securities during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024.

Current wording

Interest income decreased to $2.5 million for the three months ended March 31, 2026, as compared to $6.1 million for the three months ended March 31, 2025. The decrease in interest income of $3.6 million was primarily driven by lower aggregate balances and yield associated with our cash, cash equivalents and marketable securities during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025.

Previous wording

Interest expense, net decreased to $10.5 million for the three months ended September 30, 2025 as compared to $10.7 million for the three months ended September 30, 2024. Interest expense, net decreased by $0.2 million primarily due to lower other interest expenses offset by higher liabilities related to future royalties and milestone, net balances as of September 30, 2025 compared to September 30, 2024 in relation to the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement.

Current wording

Interest expense, net increased to $11.1 million for the three months ended March 31, 2026 as compared to $10.1 million for the three months ended March 31, 2025. Interest expense, net increased by $1.0 million primarily due to higher liabilities related to future royalties and milestone, net balances as of March 31, 2026 compared to March 31, 2025 in relation to the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement.

Previous wording

Income tax expense increased to $0.5 million for the three months ended September 30, 2025 as compared to less than $0.1 million for the three months ended September 30, 2024. Income tax expenses increased by $0.5 million primarily due to an increase in Autolus Inc.'s taxable income due to the recognition of product revenue, net and related intra-group recharges during the three months ended September 30, 2025 compared to the three months ended September 30, 2024.

Current wording

Income tax expense decreased to $0.9 million for the three months ended March 31, 2026 as compared to $2.3 million for the three months ended March 31, 2025. Income tax expenses decreased by $1.4 million primarily due to a decrease in Autolus Inc.'s taxable income due to the recognition of product revenue, net offset by related intra-group recharges during the three months ended March 31, 2026 compared to the three months ended March 31, 2025.

Previous 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 September 30, 2025, we have generated 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-market equity facility, 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, 2026, we have generated an aggregate of $1.8 billion from these capital sources.

Previous wording

As of September 30, 2025, we had cash and cash equivalents of $86.1 million and available-for-sale debt securities of $281.3 million.

Current wording

As of March 31, 2026, we had cash and cash equivalents of $130.9 million and available-for-sale debt securities of $98.5 million.

Previous wording

During the nine months ended September 30, 2025 and 2024, net cash provided by investing activities amounted to $71.9 million and net cash used in investing activities amounted to $11.0 million, respectively. Net cash provided by investing activities during the nine months ended September 30, 2025 primarily reflected purchases of marketable securities totaling $202.2 million, purchases of property and equipment totaling $19.9 million and purchases of intangible assets totalling $8.1 million, partially offset by $302.1 million in proceeds from maturity and redemption of marketable securities. During the nine months ended September 30, 2024, we used $11.0 million of cash in investing activities, all of which consisted of purchases of property and equipment.

Current wording

During the three months ended March 31, 2026 and 2025, net cash provided by investing activities amounted to $96.2 million and net cash used in investing activities amounted to $59.5 million, respectively. Net cash provided by investing activities during the three months ended March 31, 2026 primarily reflected by $113.6 million in proceeds from maturity and redemption of marketable securities, offset by purchases of marketable securities totaling $14.7 million, and purchases of property and equipment totaling $2.7 million. Net cash used in investing activities during the three months ended March 31, 2025 consisted of $71.3 million of investment in marketable securities and of $8.2 million related to purchases of property and equipment offset by $20.0 million of maturity and redemption of marketable securities.

Previous wording

During the nine months ended September 30, 2025, net cash used in financing activities totaled $2.5 million, primarily due to revenue share payments. 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.

Current wording

During the three months ended March 31, 2026, net cash used in financing activities totaled $2.1 million, primarily due to revenue share payments to Blackstone and BioNTech. During the three months ended March 31, 2025, there was no cash used or provided by financing activities.

Previous wording

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we begin to market and sell AUCATZYL, operate our new commercial manufacturing facility and advance the preclinical activities and clinical trials of our other product candidates. Our expenses will increase as we:

Current wording

We expect to continue incurring significant expenses in connection with our ongoing activities, particularly as we continue to market and sell AUCATZYL, operate our commercial manufacturing facility and advance the preclinical activities and clinical trials of our other product candidates. Our expenses may increase as we:

Previous wording

•establish and expand our sales, marketing and distribution infrastructure in connection with commercializing AUCATZYL and other product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;

Current wording

•maintain our sales, marketing and distribution infrastructure in connection with commercializing AUCATZYL and other product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;

Previous wording

•seek regulatory approvals for any other product candidates that successfully complete preclinical and clinical trials;

Current wording

•seek regulatory approvals for any product candidates that successfully complete preclinical and clinical trials;

Previous wording

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

Current wording

•retain our manufacturing, clinical, medical and development personnel;

Previous wording

•expand our infrastructure and facilities to accommodate our growing employee base; and

Current wording

•expand our infrastructure and facilities to accommodate our employee base; and

Showing the first 40 of 43 pairs. Open the source sections for the rest.

Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Since our inception, we 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 report — wording carried from elsewhere

There have been no material changes to our critical accounting estimates and significant judgments during the three months ended March 31, 2026.
Rearranged previous paragraphs (7)

Previous report — wording carried elsewhere

The following table summarizes our results of operations for the nine months ended September 30, 2025, and 2024 (in thousands):

Previous report — wording carried elsewhere

Certain manufacturing expenses incurred prior to AUCATZYL receiving the FDA approval were classified as research and development expenses, resulting in zero cost inventory. If cost of sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the nine months ended September 30, 2025, would have increased by approximately $6.6 million.

Previous report — wording carried elsewhere

The following tables provide additional detail on our research and development expenses, net (in thousands):

Previous report — wording carried elsewhere

•a decrease of $6.6 million in United Kingdom R&D tax credits (increase in R&D expense) due to no longer being eligible for the SME scheme and moving to the merged RDEC from January 1, 2025, and lower qualifying spend.

Previous report — wording carried elsewhere

•an increase of $18.5 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in selling, general and administrative activities;

Previous report — wording carried elsewhere

•an increase of $5.4 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations including increase in space utilized for these activities.

Previous report — wording carried elsewhere

Foreign exchange gains (losses), net increased to a gain of $1.8 million for the nine months ended September 30, 2025 from a loss of $12.4 million for the nine months ended September 30, 2024. The gains and losses rises on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including our cash and cash equivalents and liabilities related to future royalties and milestones.