Autolus Therapeutics plc
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
View on SEC.govAbout 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.
Sep 30, 2026 · Filed Nov 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-11.
0001730463-26-000123
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-10.
0001730463-26-000148
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 164 previous paragraphs and 166 current paragraphs.
94 unchanged; 52 reworded; 19 added; 14 removed; 4 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (19)
Current report
Obe-cel in lupus
Current report
•Our updated data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (“SLE”) will be presented in a poster at the American College of Rheumatology (“ACR”) Annual Meeting, November 10, 2026. These data will include safety and efficacy results with up to 20 months follow-up in adult patients and ≥3 months follow-up in adolescent patients.
Current report
•On September 9, 2026, the FDA granted regenerative medicine advanced therapy (“RMAT”) designation to obe-cel for the treatment of SLE and LN. RMAT is designed to accelerate the development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.
Current report
•Key opinion leader feedback at the ACTRIMS/ECTRIMS meeting in late October emphasized that initial clinical activity and biomarker data seen across CAR-T programs are encouraging but will require longer follow up to judge the clinical benefit in progressive MS patients. Considering this feedback, we plan to move the first data presentation to the ACTRIMS/ECTRIMS meeting in October 2027. At that time, we expect to have 12 months or more follow-up for the initial 12 patients dosed, and data in up to 24 patients total. Lymphodepletion with both FLu/Cy as well as bendamustine is being evaluated.
Current report
Strategic financing agreements:
Current report
Foreign Exchange Gains (Losses), Net
Current report
•an increase of $0.3 million in United Kingdom R&D tax credits (resulting in a decrease in R&D expense) primarily due to higher qualifying R&D expenditure in the current period compared with the prior-year period.
Current report
Selling, general and administrative expenses decreased by $0.3 million to $35.9 million for the three months ended September 30, 2026 from $36.2 million for the three months ended September 30, 2025 primarily due to:
Current report
•a decrease of $0.3 million in salaries and other employment related costs including share-based compensation expenses; offset by:
Current report
Foreign Exchange Gains (Losses), Net
Current report
Income Tax Benefit (Expense)
Current report
The income tax benefit of $0.5 million for the three months ended September 30, 2026 was primarily due to the increase in deferred tax asset recognized as of September 30, 2026. The income tax expense of $0.5 million was primarily due to taxes payable in relation to Autolus Inc. due to the recognition of product revenue, net offset by related intra-group recharges during the three months ended September 30, 2025.
Current report
Comparison of Nine Months Ended September 30, 2026 and 2025
Current report
Research and development expenses, net decreased by $2.1 million to $80.0 million for the nine months ended September 30, 2026 from $82.1 million for the nine months ended September 30, 2025 primarily due to:
Current report
Selling, general and administrative expenses increased by $21.0 million to $117.1 million for the nine months ended September 30, 2026 from $96.1 million for the nine months ended September 30, 2025 primarily due to:
Current report
Foreign Exchange (Losses) Gains, Net
Current report
Interest expense, net increased to $23.0 million for the nine months ended September 30, 2026 as compared to $13.8 million for the nine months ended September 30, 2025. Interest expense, net increased by $9.2 million primarily due to higher liabilities related to future royalties and milestone, net balances and senior secured notes facility as of September 30, 2026 compared to September 30, 2025. Interest expense is recognized in relation to the Collaboration Agreement with Blackstone, the BioNTech License and Option Agreement and senior secured Notes Facility with Perceptive.
Current report
Net cash used in our operating activities was $108.9 million for the nine months ended September 30, 2026, compared to net cash used in operating activities of $216.2 million for the nine months ended September 30, 2025. The decrease of $107.3 million primarily relates to increased revenues from AUCATZYL and lower cost of sales related to these revenues.
Current report
Our Notes Facility provides an additional source of liquidity to support our future funding requirements. As of September 30, 2026, we had issued $75.0 million of Tranche 1 Notes and had the option to issue up to an additional $25.0 million of Tranche 2 Notes through January 30, 2027, subject to the terms and conditions of the Note Purchase Agreement. Additional borrowings of up to $150.0 million may become available under Tranches 3 and 4 upon achievement of specified consolidated net revenue thresholds. Our ability to access and maintain borrowings under the Notes Facility is subject to compliance with certain financial and other covenants, including minimum liquidity requirements ranging from $12.5 million to $50.0 million, depending on specified consolidated net revenue and market capitalization thresholds, as well as minimum consolidated net revenue requirements. These requirements may limit the amount of cash otherwise available to fund our operations.
Removed paragraphs (14)
Previous report
•Additional data from the FELIX trial focusing on the impact of tumor burden and bridging therapy on safety and efficacy in adult r/r ALL patients treated with obe-cel were presented at the American Society of Clinical Oncology (“ASCO”) and European Hematology Association (“EHA”) annual meetings.
Previous report
Obe-cel in lupus nephritis (“LN”)
Previous report
•The Phase 1 BOBCAT trial is expected to include up to 18 adult patients and will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of MS.
Previous report
•The first preliminary results, including safety, PK/PD and biomarker data are planned to be presented at at the ACTRIMS Forum in the first quarter of 2027. A larger data set with longer follow up will be reported in the second half of 2027.
Previous report
Q2 2026 operational updates:
Previous report
•In April 2026, we announced a strategic initiative and plan to improve operational efficiency and reduce operating expenses. As part of this initiative, we implemented 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 have been recognized in the first half of 2026. The implementation of the workforce reduction plan is now substantially complete.
Previous report
Post Q2 2026 events:
Previous report
Selling, general and administrative expenses increased by $10.9 million to $41.2 million for the three months ended June 30, 2026 from $30.3 million for the three months ended June 30, 2025 primarily due to:
Previous report
Interest expense, net decreased to negative $2.7 million for the three months ended June 30, 2026 as compared to negative $6.8 million for the three months ended June 30, 2025. Interest expense, net decreased by $4.2 million primarily due to changes in the assumptions used in the valuation of the Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement. These assumption changes during the three months ended June 30, 2026 and June 30, 2025 respectively, resulted in a negative cumulative catch-up adjustment which exceeded the interest expense accrued relating to Blackstone Collaboration Agreement (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest (“BioNTech Liability”).
Previous report
Comparison of Six Months Ended June 30, 2026 and 2025
Previous report
Research and development expenses, net decreased by $5.1 million to $49.1 million for the six months ended June 30, 2026 from $54.2 million for the six months ended June 30, 2025 primarily due to:
Previous report
Selling, general and administrative expenses increased by $21.3 million to $81.1 million for the six months ended June 30, 2026 from $59.8 million for the six months ended June 30, 2025 primarily due to:
Previous report
Income Tax Expenses
Previous report
Net cash used in our operating activities was $90.4 million for the six months ended June 30, 2026, compared to net cash used in operating activities of $148.3 million for the six months ended June 30, 2025. The decrease of $58.0 million in net cash used in our operating activities was primarily driven by increases in accounts receivable, inventories net, operating lease liability and working capital movements, reflecting the timing of payments, partially offset by prepaid expenses, accounts payable and accrued expenses working capital movements.
Reworded paragraphs (52)
Previous wording
We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars, and we prepare our consolidated financial statements in accordance with U.S. GAAP, as issued by the FASB. All references in this Quarterly Report on Form 10-Q to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended June 30, 2026 and 2025 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3414 and £1.00 to $1.3355, respectively. Our unaudited condensed consolidated statements of operations and comprehensive loss and cash flows for the six months ended June 30, 2026 and 2025 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3445 and £1.00 to $1.2971, respectively. Our unaudited condensed consolidated balance sheet as of June 30, 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 $1.3242 and £1.00 to $1.3455, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at those or any other exchange rate as of those or any other dates.
Current wording
We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars, and we prepare our consolidated financial statements in accordance with U.S. GAAP, as issued by the FASB. All references in this Quarterly Report on Form 10-Q to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended September 30, 2026 and 2025 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3443 and £1.00 to $1.3482, respectively. Our unaudited condensed consolidated statements of operations and comprehensive loss and cash flows for the nine months ended September 30, 2026 and 2025 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.3445 and £1.00 to $1.3141, respectively. Our unaudited condensed consolidated balance sheet as of September 30, 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 $1.3260 and £1.00 to $1.3455, 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 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.
Current wording
We are a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates 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 and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate target cells. We believe our programmed T cell therapies have the potential to be best-in-class and 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 June 30, 2026 and 2025, we incurred net losses of $39.1 million and $47.9 million, respectively, and had an accumulated deficit of $1,497.5 million and $1,386.8 million as of June 30, 2026 and December 31, 2025, respectively.
Current wording
Since our inception, we have incurred significant operating losses. For the three months ended September 30, 2026 and 2025, we incurred net losses of $55.1 million and $79.1 million, respectively, and had an accumulated deficit of $1,552.6 million and $1,386.8 million as of September 30, 2026 and December 31, 2025, respectively.
Previous wording
As of June 30, 2026, we had cash and cash equivalents of $171.4 million and marketable securities of $30.2 million. Based on our current clinical development and commercialization plans, we believe our existing cash, cash equivalents and marketable securities, together with the $75.0 million received from its Notes Purchase Agreement with Perceptive Advisors, “Perceptive”, will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this Quarterly Report. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our product candidates, management may need to curtail its development efforts and planned operations.
Current wording
As of September 30, 2026, we had cash and cash equivalents of $245.4 million and marketable securities of $3.0 million. In addition, we have access to an additional $25.0 million of borrowing capacity under the second tranche of our senior secured notes facility through January 30, 2027. Based on our current clinical development and commercialization plans, we believe our existing cash, cash equivalents and marketable securities, together with the additional borrowing capacity available under our senior secured notes facility, will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this Quarterly Report. This forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our revenues and expenses, which we have based on assumptions that may prove to be wrong and could prove to be significantly higher than we currently anticipate, could vary materially and adversely as a result of a number of factors. Management does not know whether additional financing will be on terms favorable or acceptable to us when needed, if at all. If adequate additional funds are not available when required, or if we are unsuccessful in entering into partnership agreements for further development of our product candidates, management may need to curtail its development efforts and planned operations.
Previous wording
•We reported net product revenue of $45.7 million for three months ended June 30, 2026, compared to $20.9 million for the same period the prior year and compared to $26.2 million for three months ending March 31, 2026. Net revenues were primarily driven by increasing product demand both within existing treatment centers and expansion into new centers, supplemented by contribution from UK sales in the second quarter of launch in this market.
Current wording
•We reported net product revenue of $41.2 million for the three months ended September 30, 2026, compared to $21.1 million for the same period the prior year. Net revenues were primarily driven by increasing product demand both within existing treatment centers and expansion into new centers, supplemented by contribution from U.K. sales in the January 2026 launch in this market.
Previous wording
•Our Phase 2 portion of the ongoing CATULUS trial of obe-cel in pediatric relapsed or refractory (r/r) B-cell precursor ALL (“B-ALL”) patients is on track and data is expected to be reported at the end of 2027.
Current wording
•Our Phase 2 portion of the ongoing CATULUS trial of obe-cel in pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“r/r B-ALL”) is on track and data are expected to be reported at the end of 2027.
Previous wording
•Our next data update from the Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (“SLE”) has been submitted for presentation at the American College of Rheumatology (“ACR”) Annual Meeting in the fourth quarter of 2026. LUMINA, the pivotal Phase 2 study of obe-cel in patients with refractory LN continues enrolling in five countries and we expect to report data in 2028.
Current wording
•LUMINA, the pivotal Phase 2 study of obe-cel in patients with refractory lupus nephritis (“LN”) continues enrolling in five countries and we expect to report data in 2028.
Previous wording
•The Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing and initial data are expected to be reported at the end of 2026.
Current wording
•The Phase 1 ALARIC trial evaluating AUTO8 in light-chain amyloidosis is ongoing and initial data are expected to be reported at the American Society of Hematology meeting to held in December 2026.
Previous wording
•On July 30, 2026, we entered into a strategic financing with Perceptive for the sale of notes of up to $250 million in aggregate principal amount in a five-year, interest-only senior credit facility (the “Credit Facility”), subject to certain conditions. An initial $75 million principal amount of notes has been issued by us to Perceptive on July 30, 2026, and an additional $25 million in aggregate principal amount will be available at our option for up to six months post-closing. An additional $150 million in aggregate principal amount of subsequent capital may become available in separate tranches upon achievement of certain pre-specified revenue milestones. The Credit Facility will bear interest at a rate per annum equal to the one month secured overnight financing rate (“SOFR”) (subject to a SOFR floor of 3.50%), plus 7.25%, and will be interest-only until maturity. Interest margin reductions may become available upon achievement of certain revenue milestones. At closing of the Credit Facility, we issued Perceptive a warrant to purchase up to 3.5 million ADSs, each ADS representing one ordinary share, at an exercise price of $1.9314 per ADS, equal to 125% of the 30-day VWAP immediately preceding the closing date.
Current wording
•On July 30, 2026, we entered into a strategic financing with Perceptive for the sale of senior secured notes of up to $250 million in aggregate principal amount in a five-year, interest-only senior credit facility (the “Credit Facility”), subject to certain conditions. An initial $75 million principal amount of notes has been issued by us to Perceptive on July 30, 2026, and an additional $25 million in aggregate principal amount will be available at our option for up to six months post-closing. An additional $150 million in aggregate principal amount of subsequent capital may become available in separate tranches upon achievement of certain pre-specified revenue milestones. The Credit Facility will bear interest at a rate per annum equal to the one month secured overnight financing rate (“SOFR”) (subject to a SOFR floor of 3.50%), plus 7.25%, and will be interest-only until maturity. Interest margin reductions may become available upon achievement of certain revenue milestones. At closing of the Credit Facility, we issued Perceptive a warrant to purchase up to 3.5 million ADSs, each ADS representing one ordinary share, at an exercise price of $1.9314 per ADS, equal to 125% of the 30-day VWAP immediately preceding the closing date.
Previous wording
During the three-month and six-month period ended June 30, 2025, our product revenue, net was solely comprised of sales of AUCATZYL 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 infusion 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.
Current wording
During the three-month and nine-month period ended September 30, 2025, our product revenue, net was solely comprised of sales of AUCATZYL 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 infusion 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.
Previous wording
Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch raw materials inventory is depleted. Thus, the cost of sales as a percentage of net sales of AUCATZYL for the three and six months ended June 30, 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.
Current wording
Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch raw materials inventory is depleted. Thus, the cost of sales as a percentage of net sales of AUCATZYL for the three and nine months ended September 30, 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
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.
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. During the nine months ended September 30, 2026, we experienced 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. The reduction in force is substantially complete as of September 30, 2026.
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 the 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, we expect to incur increased expenses to remain compliant with the applicable SEC and Nasdaq requirements arising from the loss of our foreign private issuer status.
Previous wording
Foreign exchange (losses) gains, net consist of foreign currency transaction gains and losses arising from transactions denominated in foreign currencies.
Current wording
Foreign exchange gains (losses), net consist of foreign currency transaction gains and losses arising from transactions denominated in foreign currencies.
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. 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.
Current wording
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 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 $2.8 million deferred tax asset balance related to the U.S. entity at June 30, 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).
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 $3.8 million deferred tax asset balance related to the U.S. entity at September 30, 2026 for which a valuation allowance of $2.1 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
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 $24.7 million to $45.7 million for the three months ended June 30, 2026 from $20.9 million for the three months ended June 30, 2025. The increase is primarily due to an increase in the number of AUCATZYL doses administered to patients in the territories where we commercialize AUCATZYL.
Current wording
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 $20.1 million to $41.2 million for the three months ended September 30, 2026 from $21.1 million for the three months ended September 30, 2025. The increase is primarily due to an increase in the number of AUCATZYL doses administered to patients in the territories where we commercialize AUCATZYL.
Previous wording
Cost of sales decreased by $4.0 million to $20.4 million for the three months ended June 30, 2026 from $24.4 million for the three months ended June 30, 2025. The decrease was primarily attributable to the benefits of the ongoing operational efficiency initiatives announced in April 2026, improved utilization of manufacturing capacity, and lower inventory write-downs, partially offset by higher product volumes and the associated increase in third-party royalties. Cost of sales for the three months ended June 30, 2025 included inventory write-downs of $2.5 million and third-party royalties of $0.6 million. Cost of sales for the three months ended June 30, 2026 included inventory write-downs of $1.2 million and third-party royalties of $1.6 million.
Current wording
Cost of sales decreased by $10.7 million to $17.9 million for the three months ended September 30, 2026 from $28.6 million for the three months ended September 30, 2025. The decrease was primarily attributable to the benefits of the ongoing operational efficiency initiatives announced in April 2026, improved utilization of manufacturing capacity, and lower inventory write-downs, partially offset by higher product volumes and the associated increase in third-party royalties. Cost of sales for the three months ended September 30, 2026, included inventory write-downs of $1.9 million and third-party royalties of $1.6 million. Cost of sales for the three months ended September 30, 2025, included inventory write-downs of $4.3 million and third-party royalties of $0.6 million.
Previous wording
Cost of sales as a percentage of revenue decreased from 117% to 45% from the three months ended June 30, 2025 to June 30, 2026. The decrease is primarily the result of higher product volumes and operational changes at the Nucleus facility in the three months ended June 30, 2026 resulting in a lower cost per batch manufactured, including the benefits of the ongoing operational efficiency initiatives announced in April 2026.
Current wording
Cost of sales as a percentage of revenue decreased from 135% to 43% from the three months ended September 30, 2025 to September 30, 2026. The decrease is primarily the result of higher product volumes and operational changes at the Nucleus facility in the three months ended September 30, 2026 resulting in a lower cost per batch manufactured, including the benefits of the ongoing operational efficiency initiatives announced in April 2026.
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 would have increased by approximately $0.4 million and $1.9 million for the three months ended June 30, 2026 and 2025 respectively.
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 $0.5 million and $2.3 million for the three months ended September 30, 2026 and 2025 respectively.
Previous wording
Research and development expenses, net increased by $0.5 million to $27.9 million for the three months ended June 30, 2026 from $27.4 million for the three months ended June 30, 2025 primarily due to:
Current wording
Research and development expenses, net increased by $3.0 million to $30.9 million for the three months ended September 30, 2026 from $27.9 million for the three months ended September 30, 2025 primarily due to:
Previous wording
•an increase of $1.5 million in clinical trial costs, clinical manufacturing supply costs and related support costs; offset by
Current wording
•an increase of $6.7 million in clinical trial costs, clinical manufacturing supply costs and related support costs; offset by:
Previous wording
•a decrease of $4.3 million in salaries and other employment related costs including share-based compensation expense relating to research and development activities;
Current wording
•a decrease of $3.4 million in salaries and other employment related costs including share-based compensation expense relating to research and development activities; and
Previous wording
•an increase of $1.1 million in professional fees primarily related to commercialization activities in the U.S. and U.K; and
Current wording
•a decrease of $1.6 million in professional fees primarily related to commercialization activities in the U.S. and U.K; and
Previous wording
•an increase of $2.1 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations, including increase in space utilized for these activities;
Current wording
•an increase of $1.6 million in information technology infrastructure and support for information systems and facility costs relating to the conduct of corporate and commercial operations, including increase in space utilized for these activities.
Previous wording
Foreign exchange gains (losses), net decreased to a gain of $0.5 million for the three months ended June 30, 2026 as compared to a gain of $1.5 million for the three months ended June 30, 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.
Current wording
Foreign exchange gains (losses), net increased to a gain of $0.3 million for the three months ended September 30, 2026 as compared to a loss of $0.9 million for the three months ended September 30, 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, liabilities related to future royalties and milestones, net and senior secured notes facility.
Previous wording
Interest income decreased to $1.9 million for the three months ended June 30, 2026, as compared to $5.2 million for the three months ended June 30, 2025. The decrease in interest income of $3.3 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, 2026 as compared to the three months ended June 30, 2025.
Current wording
Interest income decreased to $2.1 million for the three months ended September 30, 2026, as compared to $4.4 million for the three months ended September 30, 2025. The decrease in interest income of $2.3 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, 2026 as compared to the three months ended September 30, 2025.
Previous wording
Interest expense, net increased to $8.5 million for the six months ended June 30, 2026 as compared to $3.3 million for the six months ended June 30, 2025. Interest expense, net decreased by $5.1 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, 2026 compared to the six months ended June 30, 2025.
Current wording
Interest expense, net increased to $14.5 million for the three months ended September 30, 2026 as compared to $10.5 million for the three months ended September 30, 2025. Interest expense, net increased by $4.0 million primarily due to higher liabilities related to future royalties and milestone, net balances and senior secured notes facility as of September 30, 2026 compared to September 30, 2025. Interest expense is recognized in relation to the Collaboration Agreement with Blackstone, the BioNTech License and Option Agreement and senior secured Notes Facility with Perceptive.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2026, and 2025 (in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2026, and 2025 (in thousands):
Previous wording
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 $42.0 million to $71.9 million for the six months ended June 30, 2026 from $29.9 million for the six months ended June 30, 2025. The increase is primarily due to an increase in the number of AUCATZYL doses administered in the territories where we commercialize AUCATZYL.
Current wording
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 $62.1 million to $113.1 million for the nine months ended September 30, 2026 from $51.0 million for the nine months ended September 30, 2025. The increase is primarily due to an increase in the number of AUCATZYL doses administered in the territories where we commercialize AUCATZYL.
Previous wording
Cost of sales increased by $2.6 million to $45.0 million for the six months ended June 30, 2026 from $42.4 million for the six months ended June 30, 2025. The increase was primarily attributable to higher product volumes and the associated increase in third-party royalties, partially offset by the benefits of the ongoing operational efficiency initiatives announced in April 2026 and improved utilization of manufacturing capacity. Cost of sales for the six months ended June 30, 2025 included inventory write-downs of $3.2 million and third-party royalties of $0.7 million. Cost of sales for the six months ended June 30, 2026 included inventory write-downs of $3.1 million and third-party royalties of $2.5 million.
Current wording
Cost of sales decreased by $8.1 million to $63.0 million for the nine months ended September 30, 2026 from $71.0 million for the nine months ended September 30, 2025. The decrease was primarily attributable to the benefits of the ongoing operational efficiency initiatives announced in April 2026, improved utilization of manufacturing capacity, and lower inventory write-downs, partially offset by higher product volumes and the associated increase in third-party royalties. Cost of sales for the nine months ended September 30, 2026 included inventory write-downs of $5.0 million and third-party royalties of $4.1 million. Cost of sales for the nine months ended September 30, 2025 included inventory write-downs of $7.6 million and third-party royalties of $1.2 million.
Previous wording
Cost of sales as a percentage of revenue decreased from 142% to 63% from the six months ended June 30, 2025 to June 30, 2026. The decrease is primarily the result of higher product volumes and operational changes at the Nucleus facility in the six months ended June 30, 2026 resulting in a lower cost per batch manufactured, including the benefits of the ongoing operational efficiency initiatives announced in April 2026.
Current wording
Cost of sales as a percentage of revenue decreased from 139% to 56% from the nine months ended September 30, 2025 to September 30, 2026. The decrease is primarily the result of higher product volumes and operational changes at the Nucleus facility in the nine months ended September 30, 2026 resulting in a lower cost per batch manufactured, including the benefits of the ongoing operational efficiency initiatives announced in April 2026.
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 would have increased by approximately $0.5 million and $4.3 million for the six months ended June 30, 2026 and 2025, respectively.
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 $1.0 million and $6.6 million for the nine months ended September 30, 2026 and 2025, respectively.
Previous wording
•a decrease of $3.6 million in salaries and other employment related costs including share-based compensation expense relating to research and development activities,
Current wording
•a decrease of $7.6 million in salaries and other employment related costs including share-based compensation expense relating to research and development activities;
Previous wording
•a decrease of $2.8 million which is primarily due to decreases in information technology infrastructure and support for information systems and contractor costs relating to research and development activities;
Current wording
•a decrease of $3.1 million which is primarily due to decreases in information technology infrastructure and support for information systems and contractor costs relating to research and development activities; offset by:
Previous wording
•a decrease of $1.0 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
•an increase of $6.0 million in clinical trial costs, clinical manufacturing costs, material transportation costs and utilization of raw materials and consumables relating to research and development activities; and
Previous wording
•a decrease of $3.0 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, as well as lower qualifying spend.
Current wording
•a decrease of $2.6 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, as well as lower qualifying spend.
Previous wording
•an increase of $7.4 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by termination and severance costs related to the reduction in workforce initiative announced in April 2026 and an increase in the number of employees engaged in selling, general and administrative activities;
Current wording
•an increase of $14.4 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by termination and severance costs related to the reduction in workforce initiative announced in April 2026 and an increase in the number of employees engaged in selling, general and administrative activities;
Previous wording
•an increase of $3.7 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 $5.2 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
•an increase of $2.6 million in commercial costs including legal and professional fees and marketing costs associated with market access activities; and
Current wording
•an increase of $1.1 million in commercial costs including legal and professional fees and marketing costs associated with market access activities; and
Showing the first 40 of 52 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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”), BioNTech SE (“BioNTech”) and the senior secured notes facility with Perceptive Credit Holdings V, LP (“Perceptive”)using the effective interest rate method.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
•a decrease of $2.6 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; offset by:
Previous report — wording carried elsewhere
Income tax expense increased to $0.5 million for the three months ended June 30, 2026 as compared to $0.4 million for the three months ended June 30, 2025. Income tax expenses increased by $0.1 million primarily due the mix of pre-tax income and losses incurred in various tax jurisdictions during the three months ended June 30, 2026 compared to the three months ended June 30, 2025.
Previous report — wording carried elsewhere
•an increase of $14.7 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by termination and severance costs related to the reduction in workforce initiative announced in April 2026 and an increase in the number of employees engaged in selling, general and administrative activities;
Previous report — wording carried elsewhere
•a loss on impairment of fixed assets amounting to $0.3 million.