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Autolus Therapeutics plc

For the period ended Jun 30, 2024. Filed Aug 8, 2024.

View on SEC.gov

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.

Jun 30, 2024 · Filed Aug 8, 2024

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 2024-03-31; filed 2024-05-17.

0001730463-24-000064

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

Current report: 10-Q

Period ended 2024-06-30; filed 2024-08-08.

0001730463-24-000093

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 166 previous paragraphs and 188 current paragraphs.

94 unchanged; 46 reworded; 34 added; 24 removed; 2 previous and 14 current paragraphs rearranged.

Tables are not compared: 3 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 (34)

Current report

•Our obe-cel BLA for r/r B-ALL remains on track for FDA target action date of November 16, 2024.

Current report

•The pooled analysis of the FELIX Phase 1b/2 study was presented at the American Society of Oncology (“ASCO”) and at the European Hematology Association (“EHA”) annual meetings in June 2024, with a median follow-up of 21 months. The data showed stabilization of event-free survival and overall survival, with 40% of patients in ongoing remission. 99 responders following treatment with obe-cel, 18 received a subsequent stem cell transplant (“SCT”) while in minimal residual (“MRD”)-negative response and did not show improved survival compared to patients without subsequent SCT. Patients with prolonged obe-cel persistence showed improved event-free survival and data indicated the bridging of high tumor burden patients with inotuzumab appears effective at reducing tumor burden, cytokine release syndrome (“CRS”) and immune effector cell-associated neurotoxicity syndrome (“ICANS”) without increasing liver toxicity.

Current report

•Clinical programs AUTO8, AUTO6NG and AUTO1/22 are progressing well and we are planning data updates for all programs in 2025.

Current report

•In April 2024, Autolus entered into a distribution services agreement with a subsidiary of Cardinal Health to support the ordering and distribution of obe-cel in the United States, if it receives regulatory approval.

Current report

As a company that carries out extensive R&D activities, we make claims under the U.K. R&D tax credit regime. This regime provides companies with tax relief at an effective rate of between 15% and 16.2% (subject to the rate of corporation tax we pay, if any) of qualifying R&D expenditure in an accounting period. The regime’s rules are complex, and if a tax authority were to challenge or seek to disallow our claims (in whole or in part), for example by asserting that the relevant expenditure does not meet the technical conditions to be granted tax credits, then such challenge or disallowance could have a material impact on our cash-flow and financial performance. In addition, future changes to the U.K. R&D tax credit regime may mean that we no longer qualify for it or have a material impact on the extent to which we can make claims (or benefit from them).

Current report

Impairment of operating lease right-of-use assets and related property and equipment

Current report

Impairment of operating lease right-of-use assets and related property and equipment consists primarily of impairment losses arising from the impairment of leased properties and leasehold improvements that are currently not be utilized by us.

Current report

Research and development expenses increased by $3.4 million to $36.6 million for the three months ended June 30, 2024 from $33.2 million for the three months ended June 30, 2023 primarily due to:

Current report

•an increase of $1.4 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,

Current report

•an increase of $0.4 million in depreciation and amortization related to property and equipment, offset in part by:

Current report

•an increase of $1.8 million in U.K. R&D tax credits (decrease in R&D expense) due primarily to an increase in qualifying research and development expenditures related to the Small and Medium Enterprise (“SME”) scheme,

Current report

•a decrease of $0.7 million in information technology infrastructure maintenance costs, and

Current report

General and administrative expenses increased by $10.8 million to $21.9 million for the three months ended June 30, 2024 from $11.1 million for the three months ended June 30, 2023 primarily due to:

Current report

Impairment of Operating Lease Right-of-use Assets and Related Property and Equipment

Current report

For the three months ended June 30, 2024, we recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Enfield, United Kingdom. There was no similar impairment recognized for the three months ended June 30, 2023.

Current report

Research and development expenses increased by $6.7 million to $67.3 million for the six months ended June 30, 2024 from $60.6 million for the six months ended June 30, 2023 primarily due to:

Current report

•an increase of $2.6 million in salaries and other employment related costs, including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,

Current report

•an increase of $0.2 million in depreciation and amortization related to property and equipment, offset in part by:

Current report

•a decrease of $0.6 million in information technology infrastructure maintenance costs, and

Current report

General and administrative expenses increased by $19.7 million to $40.1 million for the six months ended June 30, 2024 from $20.4 million for the six months ended June 30, 2023 primarily due to:

Current report

•an increase of $0.1 million in depreciation and amortization related to property and equipment.

Current report

For the six months ended June 30, 2023, we recognized a loss on disposal of property and equipment of $3.8 million related to fixed assets no longer being utilized in the manufacturing facility exited in Stevenage, United Kingdom. There were no such disposals for the six months ended June 30, 2024.

Current report

Impairment of Operating Lease Right-of-use Assets and Related Property and Equipment

Current report

For the six months ended June 30, 2024, we recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Enfield, United Kingdom. There was no similar impairment recognized for the six months ended June 30, 2023.

Current report

Other (expense) income, net decreased to an expense of $0.4 million for the six months ended June 30, 2024 from an income of $1.3 million for the six months ended June 30, 2023. The decrease of $1.7 million was primarily due to the strengthening of the pound sterling exchange rate relative to the U.S. dollar resulting in a net foreign exchange loss of $1.8 million, offset by a lease termination gain of $0.1 million for the six months ended June 30, 2024 as compared to the six months ended June 30, 2023.
Removed paragraphs (24)

Previous report

Key obecabtagene autoleucel (obe-cel) updates and anticipated milestones:

Previous report

•We submitted our obe-cel Biologics License Application (“BLA”) for relapsed/refractory r/r B-ALL to the U.S. Food and Drug Administration (“FDA”) in November 2023 with a Prescription Drug User Fee Act (“PDUFA”) target action date of November 16, 2024.

Previous report

•The results of the pooled analysis of the FELIX Phase 1b/2 study we presented at American Society of Hematology (“ASH”) in December 2023 showed prolonged event free survival and low overall immunotoxicity across all cohorts in r/r B-ALL, and particularly in patients with low leukemic burden at lymphodepletion.

Previous report

•Further long-term data from the FELIX, study including additional subset analysis, will be presented in oral and poster presentations at the American Society of Clinical Oncology annual meeting (“ASCO”) and European Hematology Association congress (“EHA”) at the end of May 2024 and during June 2024, respectively.

Previous report

•AUTO8 is a next-generation product candidate for multiple myeloma, which includes two CARs for the multiple myeloma targets, BCMA and CD19. Initial data from our MCARTY Phase 1 study in multiple myeloma presented at ASH in December 2023 showed AUTO8 was well tolerated, with responses observed in all patients. Enrollment of the initial cohorts are complete and further updates from our MCARTY study are anticipated in second half of 2024.

Previous report

•AUTO6NG contains a CAR that targets GD2 alongside additional programming modules to enhance the activity and persistence. A Phase 1 clinical study in children with r/r neuroblastoma was opened for enrollment in the fourth quarter of 2023 and is ongoing.

Previous report

On February 6, 2024, we concurrently entered into a series of agreements with BioNTech SE, or BioNTech. We refer to these agreements collective as the BioNTech Agreements. See Note 1 to the consolidated financial statements included in this report for a summary of the BioNTech Agreements and the proceeds we received during the three months ended March 31, 2024.

Previous report

On February 12, 2024, we completed an underwritten offering of 58,333,336 ADSs representing 58,333,336 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were$326.8 million.

Previous report

•In March 2024, our manufacturing facility in Stevenage, United Kingdom (“The Nucleus”) obtained a Manufacturer’s Importation Authorization (“MIA”), together with the accompanying Good Manufacturing Practice certificate. This authorization enables us to manufacture products for global commercial and clinical supply at The Nucleus, effective as of March 18, 2024.

Previous report

As a company that carries out extensive R&D activities, we benefit from the Small and Medium Sized Enterprise (“SME”) regime and, to the extent that our projects are grant funded, the Research and Development Expenditure Credit (“RDEC”) regime.

Previous report

Research and development expenses increased by $3.3 million to $30.7 million for the three months ended March 31, 2024 from $27.4 million for the three months ended March 31, 2023 primarily due to:

Previous report

•an increase of $1.2 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,

Previous report

General and administrative expenses increased by $8.9 million to $18.2 million for the three months ended March 31, 2024 from $9.3 million for the three months ended March 31, 2023 primarily due to:
Reworded paragraphs (46)

Previous wording

The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes to those statements included in this Quarterly Report on Form 10-Q. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and the notes thereto, which appear in our Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange Commission, or the SEC on March 21, 2024, or the Annual Report.

Current wording

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

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 generally accepted accounting principles in the United States, or U.S. GAAP, as issued by the Financial Accounting Standards Board, or FASB. All references in this Quarterly Report on Form 10-Q to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed consolidated statements of operations and comprehensive loss and cash flows for the three months ended March 31, 2024 and 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2680 and £1.00 to $1.2145, respectively. Our unaudited condensed consolidated balance sheet as of March 31, 2024 and audited consolidated balance sheet as of December 31, 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2618 and £1.00 to $1.2730, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as of that or any other date.

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 Cash Flows for the three months ended June 30, 2024 and 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2616 and £1.00 to $1.2516, respectively. Our unaudited condensed Consolidated statements of Operations and Comprehensive Loss and Cash Flows for the six months ended June 30, 2024 and 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2648 and £1.00 to $1.2330, respectively. Our unaudited condensed Consolidated Balance Sheet as of June 30, 2024 and audited Consolidated Balance Sheet as of December 31, 2023 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2645 and £1.00 to $1.2662, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at those or any other exchange rate as of those or any other dates.

Previous wording

Since our inception, we have incurred significant operating losses. For the three months ended March 31, 2024 and 2023, we incurred net losses of $52.7 million and $39.8 million, respectively, and had an accumulated deficit of $931.3 million and $878.6 million as of March 31, 2024 and December 31, 2023, respectively.

Current wording

Since our inception, we have incurred significant operating losses. For the three months ended June 30, 2024 and 2023, we incurred net losses of $58.3 million and $45.6 million, respectively, and net losses of $111.0 million and $85.4 million for the six months ended June 30, 2024 and 2023, respectively, and had an accumulated deficit of $989.5 million and $878.6 million as of June 30, 2024 and December 31, 2023, respectively.

Previous wording

As of March 31, 2024, we had cash and cash equivalents of $758.5 million. Based on our current clinical development plans, we believe our existing cash and cash equivalents will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements.

Current wording

As of June 30, 2024, we had cash and cash equivalents of $705.9 million. Based on our current clinical development plans, we believe our existing cash and cash equivalents will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements included in this report.

Previous wording

•In April 2024, the European Medicines Agency (“EMA”) accepted our obe-cel marketing authorization application (“MAA”) for r/r B-ALL. A MAA submission to the U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”) in the United Kingdom is planned for the second half of 2024.

Current wording

•In April 2024, the EMA accepted our obe-cel marketing authorization application (“MAA”) for r/r B-ALL. In the U.K. an MAA was submitted to the U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”) at the end of July 2024.

Previous wording

•The Phase 1 dose confirmation study (“CARLYSLE”) in refractory systemic lupus erythematosus (“SLE”) patients is ongoing. Two patients have been enrolled and we continue to expect initial clinical data in late 2024.

Current wording

•The Phase 1 dose confirmation study (“CARLYSLE”) in refractory systemic lupus erythematosus (“SLE”) patients is ongoing. We continue to expect initial clinical data in late 2024.

Previous wording

Pipeline clinical trials in collaboration with University College London (“UCL”), updates and anticipated milestones:

Current wording

Pipeline programs in collaboration with University College London

Previous wording

We account for our revenue pursuant to the provisions of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers. We have no products approved for commercial sale and have not generated any revenue from commercial product sales. The total revenue to date has been generated principally from license agreements. As of March 31, 2024, we had entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on licensed product sales.

Current wording

We account for our revenue pursuant to the provisions of ASC 606, Revenue from Contracts with Customers. We have no products approved for commercial sale and have not generated any revenue from commercial product sales. The total revenue to date has been generated principally from license agreements. As of June 30, 2024, we had entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on licensed product sales.

Previous wording

ASC Topic 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.

Current wording

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 wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

The U.K. operates Research and Development (“R&D”) tax incentive regimes. Under these regimes qualifying R&D expenditure incurred by U.K. companies can be included within R&D claims via the corporate tax return, resulting in reimbursable tax credits from the U.K. government.

Current wording

The U.K. operates R&D tax incentive regimes. Under these regimes qualifying R&D expenditure incurred by U.K. companies can be included within R&D claims via the corporate tax return, resulting in reimbursable tax credits from the U.K. government.

Previous wording

The SME program has been particularly beneficial to us, as under this program the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 18.6%of qualifying expenditure incurred after April 1, 2023. Additionally, the U.K. Government enacted further changes to the SME regime on February 22, 2024 which include the introduction of a new rate for R&D intensive companies of 27% (which we may qualify for) and came into effect for expenditures incurred after April 1, 2023. Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income. A large proportion of costs in relation to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.

Current wording

The SME program has been particularly beneficial to us, as under this program the trading losses that arise from our qualifying R&D activities can be surrendered for a cash rebate of up to 18.6% of qualifying expenditure incurred after April 1, 2023. Additionally, the U.K. Government enacted further changes to the SME regime on February 22, 2024 which include the introduction of a new rate for R&D intensive companies of 27% (which we may not qualify for) and came into effect for expenditures incurred after April 1, 2023. Qualifying expenditures largely comprise employment costs for research staff, consumables, outsourced contract research organization costs and utilities costs incurred as part of research projects for which we do not receive income. A large proportion of costs in relation to our pipeline research, clinical trials management and manufacturing development activities, all of which are being carried out by our subsidiary Autolus Limited, are eligible for inclusion within these tax credit cash rebate claims.

Previous wording

The benefit from U.K. RDEC and U.K. SME programs is recognized as income in the statement of profit and loss, and is subject to tax at the prevailing rate.

Current wording

The benefit from U.K. RDEC and U.K. SME programs is recognized as income in the Consolidated Statement of Operations and Comprehensive Loss and is subject to tax at the prevailing rate.

Previous wording

Amendments to the current SME and RDEC programs that are contained in the Finance Bill which was enacted on February 22, 2024 will take effect from periods on or after April 1, 2024 and will (i) (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on subcontracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the U.K. or such workers are not subject to U.K. payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies. Nevertheless, the higher rate of 27% for R&D intensive SME companies will still be in effect from periods on or after April 1, 2024.

Current wording

Amendments to the current SME and RDEC programs that are contained in the Finance Act 2024 which was enacted on February 22, 2024 will take effect from periods on or after April 1, 2024 and will (i) (unless limited exceptions apply) introduce restrictions on the tax relief that can be claimed for expenditure incurred on subcontracted R&D activities or externally provided workers, where such sub-contracted activities are not carried out in the U.K. or such workers are not subject to U.K. payroll taxes, and (ii) merge the SME and RDEC programs into a single scheme which would generate net cash benefit of up to 15% of the qualifying expenditure for profit making companies and up to 16.2% for loss making companies. Nevertheless, the higher rate of 27% for R&D intensive SME companies will still be in effect from periods on or after April 1, 2024.

Previous wording

We currently meet the conditions of the SME regime, but we also can make claims under the RDEC regime to the extent that our projects are grant funded. In addition, we may meet the conditions of the R&D intensive scheme and may be able to make claims under the SME R&D intensive regime, known as the ERIS. We may not be able to continue in the future to qualify as a small or medium-sized enterprise under the SME program, based on size criteria concerning employee headcount, turnover and gross assets. If we cease to qualify under the SME regime, we may make a claim under the RDEC regime for periods ending December 31, 2024, or the merged R&D regime from period ending December 31, 2025. It should be noted, however, that the types of qualifying expenditure in respect of which we may make claims under the RDEC regime are more restricted than under the SME regime (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME regime do not qualify for relief under the current RDEC regime).The subcontracted rules under the merged regime are more aligned to the current SME regime.

Current wording

We currently meet the conditions of the SME regime, but we also can make claims under the RDEC regime to the extent that our projects are grant funded. We may not be able to continue in the future to qualify as a small or medium-sized enterprise under the SME program, based on size criteria concerning employee headcount, turnover and gross assets. If we cease to qualify under the SME regime, we may make a claim under the RDEC regime for periods ending December 31, 2024, or the merged R&D regime from the period ending December 31, 2025. It should be noted, however, that the types of qualifying expenditure in respect of which we may make claims under the RDEC regime are more restricted than under the SME regime (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME regime do not qualify for relief under the current RDEC regime).The subcontracted rules under the merged regime are more aligned to the current SME regime.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

Un-surrendered U.K. losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of U.K. taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the United Kingdom of $418.1 million at December 31, 2023. No deferred tax assets are recognized on our U.K. losses because there is currently no indication that we will make sufficient taxable profits to utilize these tax losses. We carry a $3.3 million deferred tax asset balance related to the U.S. entity. For the three months ended March 31, 2024, 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 U.K. taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the U.K. of $418.1 million at December 31, 2023. A valuation allowance has been recognized against our deferred tax asset relating to our U.K. losses. We carried a $3.2 million deferred tax asset balance related to the U.S. entity at June 30, 2024 for which there are no valuation allowance. At June 30, 2024, we recorded a full valuation allowance against the net deferred tax asset in the U.K., as the recoverability due to future taxable profits was 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 revenues in the future, we may benefit from the U.K. “patent box” regime that allows profits attributable to revenues from patents or patented products to be taxed at an effective rate of 10%.

Previous wording

•an increase of $1.0 million in clinical trial costs primarily relating to our research and development activities, which is partially offset by a decrease in transport costs of manufacturing consumables, and

Current wording

•an increase of $4.3 million in clinical trial costs primarily relating to our research and development activities including transport costs of manufacturing consumables,

Previous wording

•an increase of $1.7 million in facilities costs related primarily to our new manufacturing facility, The Nucleus, in Stevenage, United Kingdom as well as increases in costs related to maintaining our current leased properties,

Current wording

•an increase of $0.6 million in facilities costs related primarily to our new manufacturing facility, The Nucleus, in Stevenage, U.K. as well as increases in costs related to maintaining our current leased properties, and

Previous wording

•a decrease of $0.8 million in professional consulting and legal fees in relation to our research and development activities,

Current wording

•a decrease of $0.7 million in professional consulting and legal fees in relation to our research and development activities,

Previous wording

•an increase of $4.5 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,

Current wording

•an increase of $6.7 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,

Previous wording

•an increase of $2.3 million in costs related to commercial-stage readiness activities,

Current wording

•an increase of $2.5 million in costs related to commercial-stage readiness activities,

Previous wording

•an increase of $0.2 million in facility costs due to the increase in space utilized for general and administrative activities and related to general office expenses.

Current wording

•an increase of $0.2 million in facility costs due to the increase in space utilized for general and administrative activities and related to general office expenses, offset in part by:

Previous wording

Other (expense) income, net decreased to an expense of $1.6 million for the three months ended March 31, 2024 from an income of $0.8 million for the three months ended March 31, 2023. The decrease of $2.4 million was primarily due to the strengthening of the pound sterling exchange rate relative to the U.S. dollar between the periods.

Current wording

Other income (expense), net increased to $1.2 million for the three months ended June 30, 2024 from $0.5 million for the three months ended June 30, 2023. The increase of $0.7 million was primarily due to the strengthening of the pound sterling exchange rate relative to the U.S. dollar between the two periods.

Previous wording

Interest income increased to $6.9 million for the three months ended March 31, 2024, as compared to $3.4 million for the three months ended March 31, 2023. The increase in interest income of $3.5 million primarily related to increase in yield and also higher account balances associated with our cash and cash equivalents during the three months ended March 31, 2024 as compared to the three months ended March 31, 2023.

Current wording

Interest income increased to $9.7 million for the three months ended June 30, 2024, as compared to $3.4 million for the three months ended June 30, 2023. The increase in interest income of $6.3 million primarily related to increase in yield and also higher account balances associated with our cash and cash equivalents during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023.

Previous wording

Interest expense increased to $19.3 million for the three months ended March 31, 2024 as compared to $4.9 million for the three months ended March 31, 2023. Interest expense increased by $14.4 million primarily due to an increase in the balance of the liabilities for future royalties and sales milestones, net associated with our Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement.

Current wording

Interest expense increased to $10.2 million for the three months ended June 30, 2024 as compared to $5.0 million for the three months ended June 30, 2023. Interest expense increased by $5.2 million primarily due to an increase in the balance of the liabilities for future royalties and milestones, net associated with our Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement.

Previous wording

License revenue amounting to $10.1 million for the three months ended March 31, 2024 relates to license revenue recognized pursuant to the License and Option Agreement with BioNTech SE (“BioNTech”). License revenue of $1.3 million for the three months ended March 31, 2023 primarily related to the execution of the Cabaletta Bio Inc. (“Cabaletta”) Option and License Agreement, which included recognition of a non-refundable license fee payable to us.

Current wording

License revenue amounting to $10.1 million for the six months ended June 30, 2024 related to license revenue recognized pursuant to the License and Option Agreement with BioNTech. License revenue of $1.3 million for the six months ended June 30, 2023 primarily related to the execution of the Cabaletta Bio Inc. (“Cabaletta”) Option and License Agreement, which included recognition of a non-refundable license fee payable to us.

Previous wording

•a decrease of $0.5 million in U.K. R&D tax credits (increase in R&D expense) due to a decrease in qualifying research and development expenditures and the reduction in effective tax rate related to the U.K. research and development tax credit regime under the scheme for SMEs; offset by:

Current wording

•an increase of $1.3 million in U.K. R&D tax credits (decrease in R&D expense) due primarily to an increase in qualifying research and development expenditures related to the SME scheme,

Previous wording

•an increase of $1.0 million legal and professional fees related to our general and administrative activities,

Current wording

•an increase of $2.7 million in legal and professional fees related to our general and administrative activities,

Previous wording

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

Current wording

•an increase of $0.6 million related to information technology infrastructure and support for information systems related to the conduct of corporate and commercial operations,

Previous wording

As of March 31, 2024, we had cash and cash equivalents of $758.5 million.

Current wording

As of June 30, 2024, we had cash and cash equivalents of $705.9 million.

Previous wording

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

Current wording

During the six months ended June 30, 2024, operating activities used $91.6 million of cash, resulting from our net loss of $111.0 million and net cash used resulting from changes in our operating assets and liabilities of $22.6 million, partially offset by non-cash charges of $42.0 million. The non-cash charges related to interest expense accrued and cumulative catch-up adjustment of $29.4 million, share-based compensation of $5.2 million, depreciation and amortization of $3.7 million, non-cash operating lease expense of $2.3 million, foreign exchange differences of $1.2 million, and impairment of operating lease right-of-use assets and related property and equipment of $0.4 million, which was offset by deferred income tax movement of $0.2 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the six months ended June 30, 2024 consisted primarily of a net increase of $16.7 million in prepaid expenses and other current and non-current assets, a decrease in accrued expenses and other liabilities of $4.3 million, and a decrease of $2.6 million in our operating lease liability, offset by an increase in accounts payable of $1.0 million.

Previous wording

During the three months ended March 31, 2023, operating activities used $42.4 million of cash, resulting from our net loss of $39.8 million, and net cash used resulting from changes in our operating assets and liabilities of $13.5 million, partially offset by non-cash charges of $10.9 million. The non-cash charges related to interest expense accrued of $4.9 million, loss on disposal of property and equipment of $3.8 million, share-based compensation of $2.4 million, depreciation and amortization of $1.9 million, non-cash operating lease expenses of $1.0 million, and loss on termination of operating lease of $0.1 million, offset by foreign exchange differences of $3.0 million and deferred income tax movement of $0.2 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the three months ended March 31, 2023 consisted primarily of decreases in accrued expenses and other liabilities of $7.1 million, a net increase of $4.1 million in prepaid expenses and other current and non-current assets, a decrease in operating lease liabilities of $2.2 million, and a decrease in accounts payable of $0.2 million, offset by a decrease in long-term deposits of $0.1 million.

Current wording

During the six months ended June 30, 2023, operating activities used $80.6 million of cash, resulting from our net loss of $85.4 million and net cash used resulting from changes in our operating assets and liabilities of $12.8 million, partially offset by non-cash charges of $17.6 million. The non-cash charges related to interest expense accrued and cumulative catch-up adjustment of $9.9 million, share-based compensation of $5.1 million, loss on disposal of property and equipment of $3.8 million, depreciation and amortization of $3.4 million, non-cash operating lease expense of $1.9 million, and loss on termination of operating lease of $0.1 million, offset by foreign exchange differences of $6.3 million and deferred income tax movement of $0.3 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the six months ended June 30, 2023 consisted primarily of decreases in accrued expenses and other liabilities of $9.6 million, a $6.8 million decrease in right of use assets from amortization and operating lease liabilities, net, offset by an increase in accounts payable of $3.3 million, and a net decrease of $0.2 million in prepaid expenses and other current and non-current assets, and an increase in long-term deposits of $0.1 million.

Previous wording

During the three months ended March 31, 2024 and 2023, we used $0.5 million and $3.6 million, respectively, of cash in investing activities, all of which consisted of purchases of property and equipment.

Current wording

During the six months ended June 30, 2024 and 2023, we used $1.4 million and $8.0 million, respectively, of cash in investing activities, all of which consisted of purchases of property and equipment.

Previous wording

During the three months ended March 31, 2024, net cash provided by financing activities of $561.4 million primarily related to net aggregate proceeds raised from the BioNTech Agreements and our underwritten offering of ADSs. During the three months ended March 31, 2023, net cash used in financing activities of $0.7 million was primarily for payments of issuance costs relating to a prior equity financing.

Current wording

During the six months ended June 30, 2024, net cash provided by financing activities of $559.4 million related to net aggregate proceeds raised from the BioNTech Agreements and our underwritten offering of ADSs. During the six months ended June 30, 2023, net cash used in financing activities of $0.9 million was primarily for payments of issuance costs relating to a prior equity financing.

Previous wording

An assessment of the allocation of transaction price using the relative standalone selling price was required for the three months ended March 31, 2024 and 2023 for the BioNTech License and Option Agreement and Research, Option and License Agreement with Cabaletta, respectively.

Current wording

An assessment of the allocation of transaction price using the relative standalone selling price was required for the six months ended June 30, 2024 and 2023 for the BioNTech License and Option Agreement and Research, Option and License Agreement with Cabaletta, respectively.

Showing the first 40 of 46 pairs. Open the source sections for the rest.

Rearranged current paragraphs (14)

Current report — wording carried from elsewhere

Obe-cel in r/r adult B-ALL - The Felix Study:

Current report — wording carried from elsewhere

•an increase of $1.7 million in legal and professional fees related to our general and administrative activities, and

Current report — wording carried from elsewhere

•a decrease of $0.3 million related to information technology infrastructure and support for information systems related to corporate and commercial operations.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2024, and 2023 (in thousands):

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

•an increase of $5.2 million in clinical trial costs primarily relating to our research and development activities including transport costs of manufacturing consumables,

Current report — wording carried from elsewhere

•an increase of $2.4 million in facilities costs related primarily to our new manufacturing facility, The Nucleus, in Stevenage, U.K. as well as increases in costs related to maintaining our current leased properties, and

Current report — wording carried from elsewhere

•a decrease of $1.5 million in professional consulting and legal fees in relation to our research and development activities,

Current report — wording carried from elsewhere

•an increase of $11.2 million in salaries and other employment related costs, including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,

Current report — wording carried from elsewhere

•an increase of $4.8 million in costs related to commercial-stage readiness activities,

Current report — wording carried from elsewhere

•an increase of $0.3 million in facility costs due to the increase in space utilized for general and administrative activities and related to general office expense, and

Current report — wording carried from elsewhere

Loss on disposal of property and equipment

Current report — wording carried from elsewhere

Interest income increased to $16.6 million for the six months ended June 30, 2024, as compared to $6.8 million for the six months ended June 30, 2023. The increase in interest income of $9.7 million primarily related to increase in yield and also higher account balances associated with our cash and cash equivalents during the six months ended June 30, 2024 as compared to the six months ended June 30, 2023.

Current report — wording carried from elsewhere

Interest expense increased to $29.4 million for the six months ended June 30, 2024 as compared to $9.9 million for the six months ended June 30, 2023. Interest expense increased by $19.5 million primarily due to an increase in the balance of the liabilities for future royalties and milestones, net associated with our Collaboration Agreement with Blackstone and the BioNTech License and Option Agreement.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

•a decrease of $0.2 million in depreciation and amortization related to property and equipment, and

Previous report — wording carried elsewhere

•a decrease of $0.1 million related to general office expenses.