Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 13, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-38547 | |
Entity Registrant Name | AUTOLUS THERAPEUTICS PLC | |
Entity Incorporation, State or Country Code | X0 | |
Entity Address, Address Line One | The Mediaworks | |
Entity Address, Address Line Two | 191 Wood Lane | |
Entity Address, City or Town | London | |
Entity Address, Postal Zip Code | W12 7FP | |
Entity Address, Country | GB | |
City Area Code | (44) 20 | |
Local Phone Number | 3829 6230 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 266,036,128 | |
Entity Central Index Key | 0001730463 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Current Fiscal Year End Date | --12-31 | |
ADR | ||
Document Information [Line Items] | ||
Title of 12(b) Security | American Depositary Shares, each representing one ordinary share, par value $0.000042 per share | |
Trading Symbol | AUTL | |
Security Exchange Name | NASDAQ | |
Ordinary Shares | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Ordinary shares, nominal value $0.000042 per share* | |
Security Exchange Name | NASDAQ | |
No Trading Symbol Flag | true |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 758,529 | $ 239,566 |
Restricted cash | 1,015 | 769 |
Prepaid expenses and other current assets | 44,754 | 34,967 |
Total current assets | 804,298 | 275,302 |
Non-current assets: | ||
Property and equipment, net | 33,414 | 34,862 |
Prepaid expenses and other non-current assets | 328 | 380 |
Long-term deposits | 975 | 983 |
Operating lease right-of-use assets, net | 59,126 | 60,791 |
Deferred tax asset | 3,295 | 3,063 |
Total assets | 901,436 | 375,381 |
Current liabilities: | ||
Accounts payable | 1,399 | 103 |
Accrued expenses and other liabilities | 37,768 | 39,581 |
Operating lease liabilities, current | 4,818 | 5,053 |
Total current liabilities | 43,985 | 44,737 |
Non-current liabilities: | ||
Operating lease liabilities, non-current | 46,518 | 47,914 |
Liabilities related to future royalties and milestones, net | 228,494 | 170,899 |
Other long-term payables | 409 | 357 |
Total liabilities | 319,406 | 263,907 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Additional paid-in capital | 1,542,086 | 1,018,902 |
Accumulated other comprehensive loss | (28,934) | (28,992) |
Accumulated deficit | (931,252) | (878,562) |
Total shareholders' equity | 582,030 | 111,474 |
Total liabilities and shareholders' equity | 901,436 | 375,381 |
Ordinary shares | ||
Shareholders' equity: | ||
Share value | 12 | 8 |
Deferred shares | ||
Shareholders' equity: | ||
Share value | 0 | 0 |
Deferred B Shares | ||
Shareholders' equity: | ||
Share value | 118 | 118 |
Deferred C Shares | ||
Shareholders' equity: | ||
Share value | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) | Mar. 31, 2024 $ / shares shares | Mar. 31, 2024 £ / shares shares | Dec. 31, 2023 $ / shares shares | Dec. 31, 2023 £ / shares shares |
Ordinary shares | ||||
Shareholders' equity: | ||||
Stock par value (usd/gbp per share) | $ / shares | $ 0.000042 | $ 0.000042 | ||
Shares authorized (in shares) | 290,909,783 | 290,909,783 | 290,909,783 | 290,909,783 |
Shares issued (in shares) | 265,928,023 | 265,928,023 | 174,101,361 | 174,101,361 |
Shares outstanding, including RSUs vested but not yet released (in shares) | 265,998,026 | 265,998,026 | 174,158,985 | 174,158,985 |
Deferred shares | ||||
Shareholders' equity: | ||||
Stock par value (usd/gbp per share) | £ / shares | £ 0.00001 | £ 0.00001 | ||
Shares authorized (in shares) | 34,425 | 34,425 | 34,425 | 34,425 |
Shares issued (in shares) | 34,425 | 34,425 | 34,425 | 34,425 |
Shares outstanding (in shares) | 34,425 | 34,425 | 34,425 | 34,425 |
Deferred B Shares | ||||
Shareholders' equity: | ||||
Stock par value (usd/gbp per share) | £ / shares | £ 0.00099 | £ 0.00099 | ||
Shares authorized (in shares) | 88,893,548 | 88,893,548 | 88,893,548 | 88,893,548 |
Shares issued (in shares) | 88,893,548 | 88,893,548 | 88,893,548 | 88,893,548 |
Shares outstanding (in shares) | 88,893,548 | 88,893,548 | 88,893,548 | 88,893,548 |
Deferred C Shares | ||||
Shareholders' equity: | ||||
Stock par value (usd/gbp per share) | £ / shares | £ 0.000008 | £ 0.000008 | ||
Shares authorized (in shares) | 1 | 1 | 1 | 1 |
Shares issued (in shares) | 1 | 1 | 1 | 1 |
Shares outstanding (in shares) | 1 | 1 | 1 | 1 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses: | ||
Research and development | $ (30,671) | $ (27,388) |
General and administrative | (18,177) | (9,284) |
Loss on disposal of property and equipment | 0 | (3,768) |
Total operating expenses, net | (38,757) | (39,148) |
Other income (expense): | ||
Other (expenses) income, net | (1,605) | 782 |
Interest income | 6,933 | 3,446 |
Interest expense | (19,269) | (4,905) |
Total other expense, net | (13,941) | (677) |
Net loss before income tax | (52,698) | (39,825) |
Income tax benefit | 8 | 14 |
Net loss | (52,690) | (39,811) |
Other comprehensive income (loss): | ||
Foreign currency exchange translation adjustment | 58 | 5,641 |
Total comprehensive loss | $ (52,632) | $ (34,170) |
Basic net loss per ordinary share (in usd per share) | $ (0.24) | $ (0.23) |
Diluted net loss per ordinary share (in usd per share) | $ (0.24) | $ (0.23) |
Weighted-average basic ordinary shares (in shares) | 222,170,707 | 173,825,825 |
Weighted-average diluted ordinary shares (in shares) | 222,170,707 | 173,825,825 |
License revenue | ||
Revenues | $ 10,091 | $ 1,292 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited) - USD ($) $ in Thousands | Total | Deferred Shares | Deferred B Shares | Deferred C Shares | Common shares Ordinary Shares | Common shares Deferred Shares | Common shares Deferred B Shares | Common shares Deferred C Shares | Additional Paid in Capital | Accumulated other comprehensive loss | Accumulated deficit |
Beginning balance (in shares) at Dec. 31, 2022 | 173,074,510 | 34,425 | 88,893,548 | 1 | |||||||
Beginning balance at Dec. 31, 2022 | $ 298,674 | $ 8 | $ 0 | $ 118 | $ 0 | $ 1,007,625 | $ (38,898) | $ (670,179) | |||
Stockholders' Equity | |||||||||||
Share-based compensation expense | 2,416 | 2,416 | |||||||||
Unrealized loss on foreign currency translation | 5,641 | 5,641 | |||||||||
Net loss | (39,811) | (39,811) | |||||||||
Ending balance (in shares) at Mar. 31, 2023 | 173,074,510 | 34,425 | 88,893,548 | 1 | |||||||
Ending balance at Mar. 31, 2023 | 266,920 | $ 8 | $ 0 | $ 118 | $ 0 | 1,010,041 | (33,257) | (709,990) | |||
Beginning balance (in shares) at Dec. 31, 2023 | 34,425 | 88,893,548 | 1 | 174,101,361 | 34,425 | 88,893,548 | 1 | ||||
Beginning balance at Dec. 31, 2023 | 111,474 | $ 8 | $ 0 | $ 118 | $ 0 | 1,018,902 | (28,992) | (878,562) | |||
Stockholders' Equity | |||||||||||
Issuance of ordinary shares, net of issuance costs (in shares) | 91,666,669 | ||||||||||
Stock Issued During Period, Value, New Issues | 520,617 | $ 4 | 520,613 | ||||||||
Share-based compensation expense | 2,286 | 2,286 | |||||||||
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding (in shares) | 57,524 | ||||||||||
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | $ 0 | ||||||||||
Exercise of share options (in shares) | 102,469 | 102,469 | |||||||||
Exercise of share options | $ 285 | 285 | |||||||||
Unrealized loss on foreign currency translation | 58 | 58 | |||||||||
Net loss | (52,690) | (52,690) | |||||||||
Ending balance (in shares) at Mar. 31, 2024 | 34,425 | 88,893,548 | 1 | 265,928,023 | 34,425 | 88,893,548 | 1 | ||||
Ending balance at Mar. 31, 2024 | $ 582,030 | $ 12 | $ 0 | $ 118 | $ 0 | $ 1,542,086 | $ (28,934) | $ (931,252) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (52,690) | $ (39,811) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,806 | 1,899 |
Share-based compensation net of amounts capitalized | 2,284 | 2,408 |
Interest expense accrued on liabilities related to future royalties and milestones, net | 19,260 | 4,905 |
Foreign exchange differences | 1,675 | (2,985) |
Non-cash operating lease expense | 1,136 | 928 |
Loss on termination of operating lease | 0 | 95 |
Loss on disposal of property and equipment | 0 | 3,789 |
Deferred income tax | (232) | (195) |
Changes in operating assets and liabilities: | ||
Increase in prepaid expenses and other current assets | (10,187) | (5,889) |
Decrease in prepaid expenses and other non-current assets | 77 | 1,797 |
Decrease in long-term deposits | 0 | 51 |
Increase (decrease) in accounts payable | 1,318 | (227) |
Decrease in accrued expenses and other liabilities | (3,777) | (7,056) |
Decrease in operating lease liability | (1,184) | (2,128) |
Net cash used in operating activities | (40,514) | (42,419) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (533) | (3,622) |
Net cash used in investing activities | (533) | (3,622) |
Cash flows from financing activities: | ||
Proceeds of issuance of ordinary shares | 549,977 | 0 |
Payments of equity issuance costs | (27,520) | (691) |
Proceeds from the exercise of share options | 285 | 0 |
Proceeds from liabilities related to future royalties and milestones, net | 40,000 | 0 |
Payments of issuance costs related to the liabilities related to the sale of future royalties and sales milestones, net | (1,301) | 0 |
Net cash provided by (used in) financing activities | 561,441 | (691) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (1,185) | 7,326 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 519,209 | (39,406) |
Cash, cash equivalents and restricted cash, beginning of period | 240,335 | 382,761 |
Cash, cash equivalents and restricted cash, end of period | 759,544 | 343,355 |
Supplemental non-cash flow information | ||
Property and equipment purchases included in accounts payable or accrued expenses | 555 | 3,692 |
Leased assets terminated and obtained in exchange for operating lease liabilities, net | 0 | (1,110) |
Leased assets obtained in exchange for operating lease liabilities | 0 | 5,173 |
Capitalized share-based compensation, net of forfeitures | 2 | 8 |
Capitalized implementation costs included in accrued expenses | 131 | 270 |
Equity issuance costs included in accounts payable and accrued expenses | 1,839 | 272 |
Liability issuance costs included in accounts payable and accrued expenses | 364 | 0 |
Reconciliation of cash, cash equivalents and restricted cash reported within the unaudited condensed consolidated balance sheets: | ||
Cash and cash equivalents | 758,529 | 343,027 |
Restricted cash | 1,015 | 328 |
Total cash, cash equivalents and restricted cash | $ 759,544 | $ 343,355 |
Nature of the Business
Nature of the Business | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business | Nature of the Business Autolus Therapeutics plc and its subsidiaries (collectively “Autolus” or the “Company”) is a biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using its broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and attack and kill these cells. The Company believes its 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. In November 2023, the Company submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for its lead product candidate obecabtagene autoleucel (“obe-cel”) for the treatment of relapsed/refractory (“r/r”) adult B-cell Acute Lymphoblastic Leukemia (“ALL”), with a PDUFA target action date of November 16, 2024. Autolus Therapeutics plc is registered in England and Wales. Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom. The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Obe-cel and the Company’s other product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. Even if obe-cel is approved by the FDA, the Company will need to incur significant additional costs to prepare for its commercialization. These efforts will require significant amounts of capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts for obe-cel and its other product candidates are successful, it is uncertain when, if ever, the Company will realize revenue from its product sales. BioNTech SE ( “BioNTech”) Agreements On February 6, 2024 (the “Execution Date”), the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) a Registration Rights Agreement (the “BioNTech Registration Rights Agreement”), (iii) a Letter Agreement (the “BioNTech Letter Agreement”) and (iv) a License and Option Agreement (the “BioNTech License and Option Agreement”), collectively called the “BioNTech Agreements”, with BioNTech. The BioNTech Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate. The following descriptions of the BioNTech Agreements do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements. (i) BioNTech Securities Purchase Agreement Pursuant to the BioNTech Securities Purchase Agreement the Company sold to BioNTech American Depositary Shares (“ADSs”), each representing one ordinary share with a nominal value of $0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs (the “Initial ADSs”) , representing 33,333,333 Ordinary Shares at an offering price of $6.00 per Initial ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million. In the event that BioNTech and the Company enter into a Manufacturing and Commercial Services Agreement (as defined below) within 18 months of the initial closing of the Private Placement, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $20 million. The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions. The BioNTech Securities Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech. (ii) BioNTech Registration Rights Agreement Pursuant to the BioNTech Registration Rights Agreement the Company agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs. (iii) BioNTech Letter Agreement The BioNTech Letter Agreement provides BioNTech with certain additional rights and subjects BioNTech’s investment in the Company to certain restrictions. BioNTech received the right to nominate a director to the Company’s board of directors. If BioNTech acquires beneficial ownership of at least 30% of the issued and outstanding Ordinary Shares of the Company (including in the form of ADSs) within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent. BioNTech’s director nomination rights shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages. Additionally, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions. Subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period of six months following the applicable closing date for such ADSs. The BioNTech Letter Agreement terminates upon the earlier of (a) the later of (i) February 6, 2027 and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company. (iv) BioNTech License and Option Agreement License and Options The Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (U.K.) Limited, entered into the BioNTech License and Option Agreement with BioNTech pursuant to which the Company granted to BioNTech: • an exclusive, worldwide, sublicensable license (the “Binder License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”), and • several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below: ◦ an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“Product Options”), in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize each such product candidate; ◦ an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”); ◦ an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”); and ◦ an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”). In consideration for the Binder License and the Technology Options, BioNTech made an initial payment to the Company of $10.0 million. In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $582.0 million pursuant to the License Agreement. This maximum amount includes upfront payments, the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below. The option exercise fee for each Technology Option is a low seven-digit amount. Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets. There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target. There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised. Obe-cel Product Revenue Interest BioNTech has also agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election. Manufacturing and Commercial Services Agreement Under the terms of the BioNTech License and Option Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Services Agreement” or “the MCSA”). The MCSA, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure. The Company concluded there were four freestanding financial instruments arising from the execution of the BioNTech Agreements, comprised of: 1. the Initial ADSs representing ordinary shares purchased pursuant to the BioNTech Securities Purchase Agreement; 2. the potential Subsequent ADSs representing ordinary shares that may be purchased pursuant to the BioNTech Securities Purchase Agreement; 3. the BioNTech License and Option Agreement, and 4. the MCSA. The Subsequent ADSs are classified as a forward instrument contingent on the MCSA being executed. As of March 31, 2024, the MCSA had not been entered into. The forward instrument has an inconsequential market value as the exercise price approximates the Company’s stock price on the last trading day prior to the signing date of the MCSA. Consequently, the initial proceeds arising from the purchase of Initial ADSs pursuant to the BioNTech Securities Purchase Agreement will not be separately allocated to this freestanding financial instrument at inception of the BioNTech Agreements. Furthermore, as the MCSA has yet to be entered into no consideration will be allocated to this freestanding financial instrument at inception of the BioNTech Agreements. Within the BioNTech License and Option Agreement, there are a number of embedded features which have each been assessed for freestanding financial instrument accounting in accordance to ASC 480 – Distinguishing Liabilities from Equity (“ASC 480”) . Although these embedded features are separately exercisable, they lack legal detachability and, therefore, the BioNTech License and Option Agreement is accounted for as one freestanding financial instrument. However, each embedded feature is assessed for derivative accounting in accordance to ASC 815 – Derivative and Hedging (“ASC 815”) . The Company analyzed how it should account for the host Contract ( i.e. , the BioNTech License and Option Agreement) as the Binder License represents an agreement with customer for goods and services and therefore should be accounted for under ASC 606 – Revenue from Contracts with Customers (“ASC 606”) . However, as the other embedded features of the BioNTech License and Option Agreement fall under the scope of other topics that specify how to initially measure the contract ( i.e. , ASC 470 – Debt (“ASC 470”) ), the Company determined that the host contract should not be accounted for and initially measured pursuant to ASC 606. Furthermore, the Company determined the host contract (the BioNTech License and Option Agreement) met the scope exception of ASC 815-10-15-59(d) and therefore should not be accounted for as a derivative under ASC 815 but instead be accounted for as a debt financial instrument in accordance with ASC 470. The four units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value. The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e. the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among the four units of accounting on a relative fair value basis at the time of the transaction as follows: Units of Accounting Gross proceeds (in millions) Initial fair value (in millions) Allocated consideration based on relative fair value (in millions) Net allocated consideration based on relative fair value after transaction costs* (in millions) Initial ADSs, representing ordinary shares $ 200.0 $ 200.0 $ 200.0 $ 193.8 Subsequent ADSs, representing ordinary shares $ — $ — $ — $ — BioNTech License and Option Agreement $ 50.0 $ 50.0 $ 50.0 $ 47.9 Liabilities related to future royalties and milestones, net ( Obe-cel Product Revenue Interest ) $ 40.0 $ 40.0 $ 40.0 $ 38.3 License Revenue (Binder License) $ 10.0 $ 10.0 $ 10.0 $ 9.6 MCSA $ — $ — $ — $ — Total $ 250.0 $ 250.0 $ 250.0 $ 241.7 * In addition, the total shared transaction costs of $8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. All intercompany accounts and transactions between the Company and its subsidiaries have been eliminated upon consolidation. The significant accounting policies used in the preparation of these unaudited condensed consolidated financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange Commission on March 21, 2024 (the “Annual Report”). Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. As such, the information included in these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2023, included in the Annual Report. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year ending December 31, 2024. The Company has incurred recurring losses since its inception, including net losses of $52.7 million and $39.8 million for the three months ended March 31, 2024 and 2023, respectively. The Company had an accumulated deficit of $931.3 million and $878.6 million as of March 31, 2024 and December 31, 2023, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. As of the date these unaudited condensed consolidated financial statements are issued, the Company expects that its cash and cash equivalents at March 31, 2024 of $758.5 million will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated financial statements and accordingly they have been prepared on a going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company’s planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven. Foreign Currency Translation The reporting currency of the Company maintains its accounting records is U.S. dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net income (loss) for the respective periods. The Company recorded foreign exchange loss of $1.7 million for the three months ended March 31, 2024 and a foreign exchange gain of $0.8 million for the three months ended March 31, 2023, which are included in other (expenses) income, net in the unaudited condensed consolidated statements of operations and comprehensive loss. For financial reporting purposes, the financial statements of the Company have been translated into U.S. dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign exchange adjustment to other comprehensive loss, a component of shareholders’ equity. Segment Information The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating segment, which is the business of developing and commercializing CAR T therapies. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and accrued interest expense on liability related to future royalties and sales milestones, net and related cumulative catch-up adjustment, initial lease term of the Company’s new manufacturing facility (The Nucleus), and incremental borrowing rates related to the Company's leased properties. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Allocation of transaction price using the relative standalone selling price Upfront payments are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements. Where performance obligations have been identified relating to material rights, the determination of the relative standalone selling price of these performance obligations also includes an assessment of the likelihood that the options will be exercised and any payments by the customer that are triggered upon exercising the right. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition. 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 the Option and License Agreement with Cabaletta, respectively. See Note 3 for additional information on the allocation of the transaction price for those agreements. Accrued interest expense and liability related to future royalties and milestones, net and cumulative catch-up adjustments The Company accounted for the Blackstone Collaboration Agreement (See Note 12) and the BioNTech Obe-cel Product Revenue Interest, ( “ BioNTech Liability ” ) as a liability. The Blackstone Collaboration Agreement Liability related to future royalties and sales m ilestones, net and the related accrued interest expense are measured based on the Company’s current estimates of the timing and amount of expected future royalty and milestone payments expected to be paid and the Blackstone Development Payments expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability related to future royalties and the related accrued interest expense are measured based on the Company’s current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement. Milestone payments pursuant to the BioNTech License and Option Agreement (“BioNTech Milestone Payments”) are payable upon BioNTech's election, and therefore have not been included initially in the determination of the effective interest rate. The liabilities are amortized using the effective interest rate method, resulting in recognition of accrued interest expense over the estimated term of the agreement. Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, sales milestone payments, the Blackstone Development Payment over the estimated term. If there are changes to the estimates, the Company recognizes the impact to the liability’s amortization schedule and the related accrued interest expense using the catch-up method. The Company’s estimate of the probability, timing and amount of expected future royalties and sales milestones to be paid by the Company and the expected Blackstone Development Payment to be paid to the Company, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. Additionally, the transaction costs associated with the liability will be amortized to accrued interest expense over the estimated term of the agreements. The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company’s estimate of the future royalties, sales milestones to be paid to Blackstone by the Company and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. The excess estimated present value of future royalty, sales milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense using the effective interest rate method. Recent Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or ASU 2023-07, which expanded the disclosures for reportable segments made by public entities. These amendments within ASU 2023-07 retained the existing disclosure requirements in ASC 280 and expanded upon them to require public entities to disclose significant expenses for reportable segments in both interim and annual reporting periods, as well as items that were previously disclosed only annually on an interim basis, including disclosures related to a reportable segment’s profit or loss and assets. In addition, entities with a single reportable segment must provide all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07. The amendments did not change the existing guidance on how a public entity identified and determined its reportable segments. A public entity should apply the amendments in ASU 2023-07 retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The amendments in ASU 2023-07 are effective for annual periods for all public entities in fiscal years beginning after December 15, 2023, and in interim periods within fiscal years beginning after December 15, 2024. The Company will comply with any new applicable disclosures in its Annual Report on Form 10-K for the year ending December 31, 2024. The Company does not expect the adoption to have a material effect on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company will assess the impact of this guidance on its disclosures. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s condensed consolidated financial statements and disclosures. |
License Revenue
License Revenue | 3 Months Ended |
Mar. 31, 2024 | |
Revenue from Contract with Customer [Abstract] | |
License Revenue | License Revenue Revenue, comprised of license revenue only for the three months ended March 31, 2024, and 2023 and is represented in the table below by geographical location (in thousands): Three Months Ended March 31, 2024 2023 License revenue United States — 1,292 Germany 10,091 — Total license revenue $ 10,091 $ 1,292 Major customers During the three months ended March 31, 2024, and 2023, 100% of the Company’s license revenues were generated from BioNTech and Cabaletta, respectively. License and Option Agreement with BioNTech See Note 1 for a description of the BioNTech License and Option Agreement, under which the Company recognized revenue during the three months ended March 31, 2024. For further details on the terms and accounting treatment considerations for the BioNTech Agreement, refer to following notes to these interim condensed consolidated financial statements: • Note 1, “Nature of the business” • Note 2, “Summary of significant accounting policies” • Note 10, “Shareholders’ equity” • Note 11, “Liabilities related to future royalties and milestones, net” • Note 14, “Commitments and contingencies” As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, including the Binder License and related transfer of know-how, Technology Options, and Product Options, the Company is required to consider if the embedded features are required to be bifurcated from the host contract and therefore accounted for as a separate derivative. The Company concluded the Binder License and related transfer of know-how, Technology Options, and Product Options meet the scope exception set out in ASC 815-10-15-59(d) and therefore not accounted for as derivatives under ASC 815. Binder License The Company applied ASC 606 to account for the Binder License and related know-how as functional intellectual property. The Binder License and related transfer of know-how were not distinct from one another and must be combined as a performance obligation, as BioNTech requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one combined distinct performance obligation at the inception of the BioNTech License and Option Agreement. The Company further determined the consideration received included in the transaction price at contract inception, is to be allocated to the one combined performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and Binder License to BioNTech. The Company recognized total license revenue of $10.1 million (net of foreign exchange differences), related to the BioNTech License and Option Agreement for the three months ended March 31, 2024. The Company is eligible to receive milestone payments of up to $32 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones. The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which are subject to specified limits. The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders. Under the BioNTech License and Option Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products. Milestone payments and royalty payments are regarded as variable consideration and will be evaluated under the most likely amount method. Milestone payments and royalty payments were not included in the transaction price, as these amounts were fully constrained as of March 31, 2024. Technology Options As the Technology Options are outside the scope of ASC 815, the Company considered other relevant accounting guidance to apply to this component of the BioNTech License and Option Agreement. The Company therefore applied ASC 606, considering particularly the accounting guidance related to any options granted to customers to purchase additional goods or services at a future date as this could provide a material right to the customer. A material right is a promise embedded in a current contract that should be accounted for as a separate performance obligation. The Company determined the Technology Options are not offered at a significant and incremental discount. Accordingly, the Technology Options granted to BioNTech do not represent a material right and, therefore, is not a performance obligation at the outset of the arrangement. Technology Option exercise fee equates to the standalone selling price of the technologies underlying each option and consequently, the transaction price of $10 million is not allocated to the Technology Options' performance obligation. Product Options As the Product Options are precluded from being accounted for under ASC 815 due to the scope exception, management considered the terms of the Product Options and concluded that they should be accounted for as a gain contingency under the scope of ASC 450. The Product Options, unlike the Technology Options, are 1) still subject to negotiation as to the specific activities to be performed be each party, which will be determined and agreed before the Product Options can be exercised, and 2) have not been exercised upon signature of the BioNTech License and Option Agreement. As a result, Product Options are not accounted for in under to ASC 606, and no recognition is required under ASC 450 until the Product Options are exercised. Option and License Agreement with Cabaletta On January 9, 2023, the Company entered into an Option and License Agreement (the “Cabaletta Agreement”) with Cabaletta Bio Inc. (“Cabaletta”), pursuant to which the Company granted to Cabaletta a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company’s safety switch technology (the “RQR8 technology”). Upon the execution of the Cabaletta Agreement, the Company made available the RQR8 licensed know-how to Cabaletta for a non-refundable license fee of $1.2 million. The Company has no further material performance obligations related to the Cabaletta Agreement. The Company further granted to Cabaletta the option to expand the rights and licenses granted under the Cabaletta Agreement to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of target options upon payment of an option exercise fee. The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to Cabaletta. The Company determined the option exercise fee is not offered at a significant and incremental discount. Accordingly, the option granted to Cabaletta does not represent a material right and, therefore, is not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as Cabaletta requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract. The Company further determined that the license fee payable constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the one performance obligation. The amount of the transaction price allocated to the performance obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Cabaletta. The Company recognized total license revenue of $1.2 million, related to the Cabaletta Agreement for the three months ended March 31, 2023. No license revenue was recognized related to the Cabaletta Agreement for the three months ended March 31, 2024 . Upon execution of the Cabaletta Agreement, the transaction price included only the $1.2 million non-refundable license fee payable to the Company. The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property. The future milestones, which represent variable consideration, will be evaluated under the most likely amount method, and were not included in the transaction price, as these amounts were fully constrained as of March 31, 2024. For the three months ended March 31, 2024 and 2023, the Company has not recognized any variable consideration with regards to the development milestones and sales-based milestones with its customers as they are deemed not probable. |
Interest expense
Interest expense | 3 Months Ended |
Mar. 31, 2024 | |
Banking and Thrift, Interest [Abstract] | |
Interest expense | Interest expense Interest expense consisted of the following (in thousands): Three Months Ended March 31, 2024 2023 Interest expense accrued on liabilities related to future royalties and milestones, net (refer to Note 12) $ 8,390 $ 4,905 Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) 10,870 — Other interest expense 9 — Total interest expense $ 19,269 $ 4,905 |
Net loss per ordinary share
Net loss per ordinary share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net loss per ordinary share | Net loss per ordinary share Basic and diluted net loss per ordinary share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended March 31, 2024 2023 Numerator Net loss $ (52,690) $ (39,811) Net loss - basic and diluted $ (52,690) $ (39,811) Denominator Weighted-average number of ordinary shares used in net loss per share - basic and diluted 222,170,707 173,825,825 Basic and diluted net loss per ordinary share $ (0.24) $ (0.23) For all periods presented, outstanding but unvested restricted stock units and share options have been excluded from the calculation, because their effects would be anti-dilutive. Therefore, the weighted average number of ordinary shares used to calculate both basic and diluted loss per share is the same for all periods presented. The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended March 31, 2024 2023 Unvested restricted stock units 45,719 382,375 Share options 17,731,649 13,083,768 Warrants 3,265,306 3,265,306 Total potentially dilutive securities 21,042,674 16,731,449 |
Fair value measurements
Fair value measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels: •Level 1 — Quoted prices in active markets for identical assets or liabilities. •Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. •Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments. The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): Three Months Ended March 31, 2024 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash and cash equivalents: Money market funds $ 589,969 $ 589,969 — — Total $ 589,969 $ 589,969 $ — $ — Year Ended December 31, 2023 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash and cash equivalents: Money market funds $ 184,635 $ 184,635 — — Total $ 184,635 $ 184,635 $ — $ — |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): March 31, December 31, 2024 2023 Research and development claims receivable $ 22,434 $ 19,209 Prepayments 11,126 8,638 VAT receivable 3,315 2,771 Accrued interest income 2,953 999 Deferred cost 1,660 1,787 Withholding tax receivable 1,582 — Other receivables 736 516 Lease and lease deposit receivable 948 938 Accounts receivable — 109 Total prepaid expenses and other current assets $ 44,754 $ 34,967 |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): March 31, December 31, 2024 2023 Lab equipment $ 41,193 $ 32,232 Office equipment 4,531 3,777 Furniture and fixtures 2,440 2,360 Leasehold improvements 14,218 12,728 Assets under construction 1,358 12,539 Less: accumulated depreciation (30,326) (28,774) Total property and equipment, net $ 33,414 $ 34,862 Depreciation expense for the three months ended March 31, 2024 and 2023 was $1.8 million and $1.9 million, respectively. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following (in thousands): March 31, December 31, 2024 2023 Research and development costs $ 17,702 $ 19,825 Compensation and benefits 11,262 14,757 Professional fees 8,234 4,466 Other accrued liabilities 570 533 Total accrued expenses and other liabilities $ 37,768 $ 39,581 |
Shareholders_ Equity
Shareholders’ Equity | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Shareholders’ Equity | Shareholders’ Equity Ordinary Shares Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the Company’s board of directors and declared by the shareholders. As of March 31, 2024, the Company has not declared any dividends. Restricted Stock Units At March 31, 2024, restricted stock unit awards for 70,003 ordinary shares had vested but the underlying shares had not been issued. However, these vested stock unit awards have been included in the calculation of the Company’s outstanding shares at March 31, 2024 as they are considered issuable for little or no cash consideration. Subsequent to March 31, 2024, 69,903 of these underlying ordinary shares were issued. February 2024 Underwritten Offering On February 12, 2024, the Company 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 . BioNTech Securities Purchase Agreement Concurrently with the execution of the BioNTech License and Option Agreement (see Note 1 and Note 3), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement pursuant to which the Company sold ADSs, each representing one ordinary share, to BioNTech in a private placement transaction (the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million . In the event that BioNTech and the Company enter into the MCSA within 18 months of the initial closing of the Private Placement, BioNTech will purchase up to 15,000,000 ADSs for an aggregate purchase price of up to $20 million, subject to additional limitations and restrictions. |
Share-based Compensation
Share-based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-based Compensation | Share-based Compensation The following table summarizes the total share-based compensation expense included in the unaudited condensed consolidated statements of operations (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 450 $ 1,681 General and administrative 1,836 727 Capitalized (2) 8 Total share-based compensation expense $ 2,284 $ 2,416 Share Options The table below summarizes Company’s share option activity during the three months ended March 31, 2024: Number of Weighted- Weighted- Aggregate Intrinsic Value (1) (in thousands) Outstanding as of December 31, 2023 17,956,385 $ 5.64 8.35 $ 48,968 Granted 654,950 6.17 172 Exercised (102,469) 2.74 315 Forfeited (702,716) 3.43 2,105 Expired (74,501) 16.41 13 Outstanding as of March 31, 2024 17,731,649 $ 5.71 8.16 $ 45,811 Exercisable as of March 31, 2024 7,517,388 9.10 7.06 12,223 Vested and expected to vest as of March 31, 2024 17,731,649 5.71 8.16 45,811 (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of March 31, 2024 During the three months ended March 31, 2024, the Company modified the exercise period of 571,352 share options resulting in the recognition of $0.2 million incremental share-based compensation expen se. The total intrinsic value of options exercised was $0.3 million for the three months ended March 31, 2024. The weighted average grant-date fair value of share options granted was $4.53, per share option for the three months ended March 31, 2024. As of March 31, 2024, the total unrecognized compensation expense related to unvested share options without performance conditions was $12.1 million, which the Company expects to recognize over a weighted average vesting period of 3.24 years. As of March 31, 2024, the total unrecognized share-based compensation expense related to unvested share options with performance conditions was $2.9 million, which the Company expects to recognize over a weighted average vesting period of 0.63 years. Restricted Stock Units The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the three months ended March 31, 2024: Number of Weighted average Unvested and outstanding at December 31, 2023 116,436 $ 3.43 Granted — — Vested (69,903) 2.61 Forfeited (814) 6.20 Unvested and outstanding at March 31, 2024 45,719 $ 4.63 As of March 31, 2024, there was less than $0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which is expected to be recognized over a weighted average period of 1.81 years . |
Liabilities related to future r
Liabilities related to future royalties and milestones, net | 3 Months Ended |
Mar. 31, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Liabilities related to future royalties and milestones, net | Liabilities related to future royalties and milestones, net March 31, December 31, 2024 2023 Liabilities related to future royalties and milestones, net $ 228,494 $ 170,899 Total Liabilities related to future royalties and milestones, net $ 228,494 $ 170,899 During the three months ended March 31, 2024 and 2023 interest expense accrued on liabilities related to future royalties and milestones, net amounted to $8.4 million and $4.9 million, respectively. During the three months ended March 31, 2024 and 2023 cumulative catch-up adjustment (included in interest expense) amounted to $10.9 million and nil, respectively. Blackstone Collaboration Agreement On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”): (i) Strategic Collaboration Agreement (the “Blackstone Collaboration Agreement”), (ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), (iii) Warrant Agreement (the “Blackstone Warrant”) and (iv) a Registration Rights Agreement (the “Blackstone Registration Rights Agreement”). The Blackstone Collaboration Agreement, the Blackstone Securities Purchase Agreement, the Blackstone Warrant and the Blackstone Registration Rights Agreement are collectively referred to as the “Blackstone Agreements”. The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for the Blackstone Agreements in the aggregate. For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report: • Note 2, “Summary of significant accounting policies” • Note 11, “Liability related to future royalties and sales milestones, net” • Note 12, “ Warrants ” • Note 13, “Shareholders’ equity” Pursuant to the Blackstone Collaboration Agreement, Blackstone agreed to pay the Company up to $150 million to support the continued development of the Company’s CD19 CAR T cell investigational therapy product candidate, obecabtagene autoleucel (obe-cel), as well as next generation product therapies of obe-cel in B-cell malignancies. These payments include (i) an upfront payment of $50 million and (ii) up to $100 million payable based on the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”). In November 2021, the upfront payment of $50 million was paid by Blackstone upon execution of the Blackstone Collaboration Agreement. In December 2022, two Blackstone Development Payments were paid by Blackstone of $35 million each as a result of (i) the joint steering committee’s review of the Company’s interim analysis of pivotal FELIX Phase 2 clinical trial of obe-cel in r/r ALL and (ii) achievement of a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of the Company’s obe-cel’s manufacturing process. The remaining $30 million will be payable to the Company on the achievement on certain specified regulatory milestones. The Company considers the achievement of the specified regulatory milestone as probable when actually achieved. The carrying amount of the Blackstone Collaboration Agreement Liability is based on the Company’s estimate of the future royalties and sales milestones to be paid to Blackstone and the Blackstone Development Payment to be received over the life of the arrangement as discounted using an effective interest rate. The excess estimated present value of future royalties and sales milestone payments over the initial carrying amount and future Blackstone Development Payments received, is recognized as a cumulative catch-up method within interest expense using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the Blackstone Collaboration Agreement Liability was approximately 15.80% as of March 31, 2024 and December 31, 2023. BioNTech Agreements On February 6, 2024, the Company concurrently entered into the BioNTech Agreements. For further details on the terms and accounting treatment considerations for these contracts, refer to following notes to these interim condensed consolidated financial statements: • Note 1, “Nature of the business” • Note 2, “Summary of significant accounting policies” • Note 3, “License Revenue” • Note 10, “Shareholders’ equity” • Note 14, “Commitment and contingencies” Obe-cel Product Revenue Interest Under the BioNTech License and Option Agreement, BioNTech has agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech's election. As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features including for example the Obe-cel Product Revenue Interest including milestone payments and royalties, the Company is required to consider if these embedded features are required to bifurcated from the host contract and therefore accounted for as a separate derivative. Firstly, the Company determined the host contract to debt-like and therefore the embedded features were analyzed pursuant to a debt host contract. Furthermore, the Company concluded the BioNTech License and Option Agreement (the host contract) should not be accounted as a derivative in accordance with ASC 815-10-15-59(d) but rather as a debt instrument under ASC 470 - Debt . The Company has accounted for the Obe-cel Product Revenue Interest as a liability primarily due to the Company’s significant continuing involvement in generating the royalty stream. The Company initially recognized the BioNTech liability at $38.3 million being the face value less debt issuance costs. If and when obe-cel is commercialized and royalties become payable, the Company will recognize the portion of royalties paid to BioNTech as a decrease to the liability with a corresponding reduction in cash. The carrying amount of the BioNTech liability is based on the Company’s estimate of the future royalties to be paid to BioNTech to be received over the life of the arrangement as discounted using an effective interest rate. The excess estimated present value of future royalties over the initial carrying amount, is recognized as a cumulative catch-up method within interest expense using the initial effective interest rate. The imputed rate of interest on the unamortized portion of the BioNTech liability was approximately 28.70% as of February 6, 2024 and March 31, 2024. On a quarterly basis, the Company assesses the amount and timing of expected royalty using a combination of internal projections and forecasts from external sources. To the extent the present value of such payments are greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will adjust the amortization of the BioNTech Liability using the catch-up method. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Leases | Leases Operating leases - Lessee The Company leases certain office space, laboratory space, and equipment. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company’s costs as a lessee for the three months ended March 31, 2024 and 2023 were as follows (in thousands): Three Months Ended March 31, 2024 2023 Operating lease costs $ 2,098 $ 1,367 Variable costs 544 (271) Short term lease costs 101 25 Total lease costs $ 2,743 $ 1,121 Supplemental cash flow information for the three months ended March 31, 2024 and 2023 were as follows: Three Months Ended March 31, Other information 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows from operating leases (in thousands) $ 1,725 $ 1,296 The weighted average remaining lease term and weighted average discount rate of operating leases at March 31, 2024 and 2023 were as follows: Three Months Ended March 31, 2024 2023 Weighted-average remaining lease term - operating leases 16.0 years 11.9 years Weighted-average discount rate - operating leases 7.44 % 6.87 % The maturities of operating lease liabilities as of March 31, 2024 were as follows (in thousands): Remainder of 2024 $ 5,742 2025 6,841 2026 6,610 2027 6,467 2028 5,752 Thereafter 56,536 Total lease payments 87,948 Less: imputed interest (36,612) Present value of lease liabilities $ 51,336 Operating leases - Lessor (sublease agreements) The Company subleases two manufacturing spaces in Enfield, United Kingdom to third parties. The annual lease payments to be received for each of the subleased units are £97,000 and £109,000, over lease terms from October 2021 to February 2029 and October 2021 to October 2026, respectively. The following table shows the sublease rental income for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, Sublease rental income 2024 2023 Sublease rental income (included in other (expenses) income, net) $ 62 $ 59 Total sublease rental income $ 62 $ 59 Future fixed receipts for non-cancellable operating subleases in effect as of March 31, 2024 are receivable as follows (in thousands): Remainder of 2024 $ 195 2025 $ 260 2026 $ 202 2027 $ 122 2028 $ 105 Total lease payments receivable $ 884 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies License Agreements The Company has entered into an exclusive license agreement, as amended, with UCL Business Ltd ( “ UCLB ” ). In connection with the UCLB license agreement, the Company is required to make annual license payments and may be required to make payments to UCLB upon the achievement of specified milestones. During the three months ended March 31, 2024, less than $0.1 million was paid or payable to UCLB by the Company, relating to the income allocable to the value of the sublicensed intellectual property rights. In November 2019, the Company entered into an exclusive license agreement with Noile-Immune Biotech Inc. ( “ Noile ” ) under which the Company will have the right to develop CAR T cell therapies incorporating Noile’s PRIME (proliferation-inducing and migration-enhancing) technology. The Company may be obligated to make additional payments to Noile upon the achievement of development milestones and receipt of regulatory approvals product sale milestones, as well as royalty payments based on possible future sales resulting from the utilization of the licensed technology. In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG ( “ Miltenyi ” ) under which the Company received a sublicense related to the use of certain Miltenyi products in the Company’s development, manufacture and sale of its products. Under the agreement, the Company is obligated to make specified payments to Miltenyi upon the achievement of certain regulatory and clinical milestones. The Company recognized $0.4 million of expense in aggregate relating to an upfront license payment and milestone payments that were deemed probable during the year ended December 31, 2023. The Company did not recognize any further milestone payments during the three months ended March 31, 2024 Contractual obligations In July 2022, the Company renegotiated a master services agreement with Adaptive Biotechnologies Corporation ( “ Adaptive ” ), under which Adaptive's assay is used to analyze patient samples from relapsed/refractory B Cell Acute Lymphoblastic Leukemia ( “ rrB-ALL ” ) patients. Under the agreement, the Company is obligated to make specified payments to Adaptive upon the achievement and receipt of certain regulatory approvals and achievement of commercial milestones in connection with the Company’s use of the Adaptive assay. During the year ended December 31, 2023, the Company recognized all contractual milestones relating to this contract as a result no contractual milestones were recognized during the three months ended March 31, 2024. In previous periods, the Company has entered into agreements with certain advisory firms. The Company is obligated to make specified payments upon the achievement of certain strategic transactions involving the Company. During the three months ended March 31, 2024, the Company paid a fee under these agreements. The Company has estimated the probability of the Company achieving each potential milestone in relation to the agreements with UCLB, Noile, Miltenyi and its agreements with certain advisory firms in accordance with ASC 450, Contingencies . The Company considers the regulatory approval, commercial milestones and execution of collaboration agreements probable when actually achieved. Furthermore, the Company recognizes expenses for clinical milestones when their achievement is deemed probable. The Company concluded that, as of March 31, 2024, there were no other no milestones for which the likelihood of achievement was currently probable. Capital Commitments As of March 31, 2024, the Company’s unconditional purchase obligations for capital expenditures totaled $9.9 million and include signed orders for capital equipment and capital expenditures for construction and related expenditures relating to its properties in the United Kingdom and the United States. Of this amount the Company expects to incur the full amount within one year. Blackstone and BioNTech Agreements Refer to Note 12, “Liabilities related to future royalties and milestone, net” for further details about the BioNTech Agreements and Blackstone Agreements. BioNTech License and Option Agreement - Product Options gain contingency As the Product Options within the BioNTech License and Option Agreement were an embedded feature within a freestanding financial instrument, the Company assessed if the Product Options should be accounted for as a derivative under ASC 815. However, the Company determined the Product Options met the scope exception for derivative accounting under ASC 815 and therefore should be accounted for a gain contingency under the scope of ASC 450. As of March 31, 2024, Product Options were not realized or realized and therefore no amounts were recognized. Legal Proceedings From time to time, the Company may be a party to litigation or subject to claims incident to the ordinary course of business. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors. The Company was not a party to any litigation and did not have contingency reserves established for any liabilities as of March 31, 2024 and December 31, 2023. Indemnification Agreements In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because they involve claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. In accordance with the indemnification agreements entered into with relevant individuals in accordance with the Company’s Articles of Association, the Company has indemnification obligations to its directors, officers and members of senior management for certain events or occurrences, subject to certain limits, while they are serving at the Company’s request in such capacity. There have been no claims to date under these indemnification agreements, and the Company has director and officer insurance that may enable it to recover a portion of any amounts paid for future potential claims. |
Related party transactions
Related party transactions | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions [Abstract] | |
Related party transactions | Related party transactions Blackstone Agreements In November 2021, the Company concurrently entered into the Blackstone Agreements. Subsequent to the execution of the Blackstone Agreements, Blackstone became a related party of the Company. Blackstone owns more than 10% of the Company’s outstanding voting securities and is therefore one of the principal owners of the Company. In addition, Blackstone received and exercised its right to nominate one director to the board of directors of the Company. As of March 31, 2024, the carrying amount of the Blackstone Collaboration Agreement Liability was $188.5 million which included aggregated cumulative non-cash interest expense and cumulative catch-up adjustment of $17.6 million. As of December 31, 2023, the carrying amount of the Blackstone Collaboration Agreement Liability was $170.9 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $45.0 million. Refer to Note 12, “ Liabilities related to future royalties and milestones, net ” for further details. BioNTech Agreements In February 2024, the Company concurrently entered into the BioNTech Agreements. Subsequent to the execution of the BioNTech Agreements, BioNTech became a related party of the Company. BioNTech owns more than 10% of the Company’s outstanding voting securities and is therefore one of the principal owners of the Company. In addition, BioNTech has the right to nominate 1 director to the board of directors of the Company which BioNTech has not yet exercised. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events The Company evaluated subsequent events through May 17, 2024, the date on which these unaudited condensed consolidated financial statements were is |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net loss | $ (52,690) | $ (39,811) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 shares | |
Trading Arrangements, by Individual | |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
David Brochu [Member] | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On March 29, 2024, David Brochu, our Chief Technical Officer, adopted a “Rule 10b5-1 trading arrangement” as defined in Item 408(a) of Regulation S-K, which is intended to satisfy the affirmative defense of Rule 10b5-1(c). The sales plan has an initial term ending on June 30, 2026 and covers the sale of a total of 828,744 ADSs, each representing one ordinary share with a nominal value of $0.000042 per share, of the Company. |
Name | David Brochu |
Title | Chief Technical Officer |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | March 29, 2024 |
Arrangement Duration | 823 days |
Aggregate Available | 828,744 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. All intercompany accounts and transactions between the Company and its subsidiaries have been eliminated upon consolidation. The significant accounting policies used in the preparation of these unaudited condensed consolidated financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange Commission on March 21, 2024 (the “Annual Report”). Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three months ended March 31, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. As such, the information included in these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2023, included in the Annual Report. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year ending December 31, 2024. The Company has incurred recurring losses since its inception, including net losses of $52.7 million and $39.8 million for the three months ended March 31, 2024 and 2023, respectively. The Company had an accumulated deficit of $931.3 million and $878.6 million as of March 31, 2024 and December 31, 2023, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. As of the date these unaudited condensed consolidated financial statements are issued, the Company expects that its cash and cash equivalents at March 31, 2024 of $758.5 million will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated financial statements and accordingly they have been prepared on a going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company’s planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven. |
Foreign Currency Translation | Foreign Currency Translation The reporting currency of the Company maintains its accounting records is U.S. dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net income (loss) for the respective periods. The Company recorded foreign exchange loss of $1.7 million for the three months ended March 31, 2024 and a foreign exchange gain of $0.8 million for the three months ended March 31, 2023, which are included in other (expenses) income, net in the unaudited condensed consolidated statements of operations and comprehensive loss. For financial reporting purposes, the financial statements of the Company have been translated into U.S. dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign exchange adjustment to other comprehensive loss, a component of shareholders’ equity. |
Segment Information | Segment Information The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating segment, which is the business of developing and commercializing CAR T therapies. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and accrued interest expense on liability related to future royalties and sales milestones, net and related cumulative catch-up adjustment, initial lease term of the Company’s new manufacturing facility (The Nucleus), and incremental borrowing rates related to the Company's leased properties. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Allocation of transaction price using the relative standalone selling price Upfront payments are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements. Where performance obligations have been identified relating to material rights, the determination of the relative standalone selling price of these performance obligations also includes an assessment of the likelihood that the options will be exercised and any payments by the customer that are triggered upon exercising the right. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition. 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 the Option and License Agreement with Cabaletta, respectively. See Note 3 for additional information on the allocation of the transaction price for those agreements. Accrued interest expense and liability related to future royalties and milestones, net and cumulative catch-up adjustments The Company accounted for the Blackstone Collaboration Agreement (See Note 12) and the BioNTech Obe-cel Product Revenue Interest, ( “ BioNTech Liability ” ) as a liability. The Blackstone Collaboration Agreement Liability related to future royalties and sales m ilestones, net and the related accrued interest expense are measured based on the Company’s current estimates of the timing and amount of expected future royalty and milestone payments expected to be paid and the Blackstone Development Payments expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability related to future royalties and the related accrued interest expense are measured based on the Company’s current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement. Milestone payments pursuant to the BioNTech License and Option Agreement (“BioNTech Milestone Payments”) are payable upon BioNTech's election, and therefore have not been included initially in the determination of the effective interest rate. The liabilities are amortized using the effective interest rate method, resulting in recognition of accrued interest expense over the estimated term of the agreement. Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, sales milestone payments, the Blackstone Development Payment over the estimated term. If there are changes to the estimates, the Company recognizes the impact to the liability’s amortization schedule and the related accrued interest expense using the catch-up method. The Company’s estimate of the probability, timing and amount of expected future royalties and sales milestones to be paid by the Company and the expected Blackstone Development Payment to be paid to the Company, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. Additionally, the transaction costs associated with the liability will be amortized to accrued interest expense over the estimated term of the agreements. The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company’s |
Recent Accounting Pronouncements Not Yet Adopted | Recent Accounting Pronouncements Not Yet Adopted In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or ASU 2023-07, which expanded the disclosures for reportable segments made by public entities. These amendments within ASU 2023-07 retained the existing disclosure requirements in ASC 280 and expanded upon them to require public entities to disclose significant expenses for reportable segments in both interim and annual reporting periods, as well as items that were previously disclosed only annually on an interim basis, including disclosures related to a reportable segment’s profit or loss and assets. In addition, entities with a single reportable segment must provide all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07. The amendments did not change the existing guidance on how a public entity identified and determined its reportable segments. A public entity should apply the amendments in ASU 2023-07 retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The amendments in ASU 2023-07 are effective for annual periods for all public entities in fiscal years beginning after December 15, 2023, and in interim periods within fiscal years beginning after December 15, 2024. The Company will comply with any new applicable disclosures in its Annual Report on Form 10-K for the year ending December 31, 2024. The Company does not expect the adoption to have a material effect on its financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company will assess the impact of this guidance on its disclosures. Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s condensed consolidated financial statements and disclosures. |
Fair value measurements | The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels: •Level 1 — Quoted prices in active markets for identical assets or liabilities. •Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. •Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments. |
Nature of the Business (Tables)
Nature of the Business (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Units of Accounting from Financing Agreement | The four units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value. The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e. the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among the four units of accounting on a relative fair value basis at the time of the transaction as follows: Units of Accounting Gross proceeds (in millions) Initial fair value (in millions) Allocated consideration based on relative fair value (in millions) Net allocated consideration based on relative fair value after transaction costs* (in millions) Initial ADSs, representing ordinary shares $ 200.0 $ 200.0 $ 200.0 $ 193.8 Subsequent ADSs, representing ordinary shares $ — $ — $ — $ — BioNTech License and Option Agreement $ 50.0 $ 50.0 $ 50.0 $ 47.9 Liabilities related to future royalties and milestones, net ( Obe-cel Product Revenue Interest ) $ 40.0 $ 40.0 $ 40.0 $ 38.3 License Revenue (Binder License) $ 10.0 $ 10.0 $ 10.0 $ 9.6 MCSA $ — $ — $ — $ — Total $ 250.0 $ 250.0 $ 250.0 $ 241.7 * In addition, the total shared transaction costs of $8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis. |
License Revenue (Tables)
License Revenue (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Revenue by Geographic Locations | Revenue, comprised of license revenue only for the three months ended March 31, 2024, and 2023 and is represented in the table below by geographical location (in thousands): Three Months Ended March 31, 2024 2023 License revenue United States — 1,292 Germany 10,091 — Total license revenue $ 10,091 $ 1,292 |
Interest expense (Tables)
Interest expense (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Banking and Thrift, Interest [Abstract] | |
Interest Income and Interest Expense Disclosure | Interest expense consisted of the following (in thousands): Three Months Ended March 31, 2024 2023 Interest expense accrued on liabilities related to future royalties and milestones, net (refer to Note 12) $ 8,390 $ 4,905 Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) 10,870 — Other interest expense 9 — Total interest expense $ 19,269 $ 4,905 |
Net loss per ordinary share (Ta
Net loss per ordinary share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Basic and diluted net loss per ordinary share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended March 31, 2024 2023 Numerator Net loss $ (52,690) $ (39,811) Net loss - basic and diluted $ (52,690) $ (39,811) Denominator Weighted-average number of ordinary shares used in net loss per share - basic and diluted 222,170,707 173,825,825 Basic and diluted net loss per ordinary share $ (0.24) $ (0.23) |
Schedule of Anti-dilutive Securities | The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: Three Months Ended March 31, 2024 2023 Unvested restricted stock units 45,719 382,375 Share options 17,731,649 13,083,768 Warrants 3,265,306 3,265,306 Total potentially dilutive securities 21,042,674 16,731,449 |
Fair value measurements (Tables
Fair value measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements, Recurring and Nonrecurring | The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): Three Months Ended March 31, 2024 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash and cash equivalents: Money market funds $ 589,969 $ 589,969 — — Total $ 589,969 $ 589,969 $ — $ — Year Ended December 31, 2023 Total Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Financial assets Cash and cash equivalents: Money market funds $ 184,635 $ 184,635 — — Total $ 184,635 $ 184,635 $ — $ — |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): March 31, December 31, 2024 2023 Research and development claims receivable $ 22,434 $ 19,209 Prepayments 11,126 8,638 VAT receivable 3,315 2,771 Accrued interest income 2,953 999 Deferred cost 1,660 1,787 Withholding tax receivable 1,582 — Other receivables 736 516 Lease and lease deposit receivable 948 938 Accounts receivable — 109 Total prepaid expenses and other current assets $ 44,754 $ 34,967 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Depreciation | Property and equipment, net consisted of the following (in thousands): March 31, December 31, 2024 2023 Lab equipment $ 41,193 $ 32,232 Office equipment 4,531 3,777 Furniture and fixtures 2,440 2,360 Leasehold improvements 14,218 12,728 Assets under construction 1,358 12,539 Less: accumulated depreciation (30,326) (28,774) Total property and equipment, net $ 33,414 $ 34,862 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following (in thousands): March 31, December 31, 2024 2023 Research and development costs $ 17,702 $ 19,825 Compensation and benefits 11,262 14,757 Professional fees 8,234 4,466 Other accrued liabilities 570 533 Total accrued expenses and other liabilities $ 37,768 $ 39,581 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share Based Compensation Expense | The following table summarizes the total share-based compensation expense included in the unaudited condensed consolidated statements of operations (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 450 $ 1,681 General and administrative 1,836 727 Capitalized (2) 8 Total share-based compensation expense $ 2,284 $ 2,416 |
Stock Option Rollforward | The table below summarizes Company’s share option activity during the three months ended March 31, 2024: Number of Weighted- Weighted- Aggregate Intrinsic Value (1) (in thousands) Outstanding as of December 31, 2023 17,956,385 $ 5.64 8.35 $ 48,968 Granted 654,950 6.17 172 Exercised (102,469) 2.74 315 Forfeited (702,716) 3.43 2,105 Expired (74,501) 16.41 13 Outstanding as of March 31, 2024 17,731,649 $ 5.71 8.16 $ 45,811 Exercisable as of March 31, 2024 7,517,388 9.10 7.06 12,223 Vested and expected to vest as of March 31, 2024 17,731,649 5.71 8.16 45,811 (1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of March 31, 2024 |
Schedule of Nonvested Share Activity | The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the three months ended March 31, 2024: Number of Weighted average Unvested and outstanding at December 31, 2023 116,436 $ 3.43 Granted — — Vested (69,903) 2.61 Forfeited (814) 6.20 Unvested and outstanding at March 31, 2024 45,719 $ 4.63 |
Liabilities related to future_2
Liabilities related to future royalties and milestones, net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Liability Related Debt Arising Financial Agreement | March 31, December 31, 2024 2023 Liabilities related to future royalties and milestones, net $ 228,494 $ 170,899 Total Liabilities related to future royalties and milestones, net $ 228,494 $ 170,899 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Lease Cost | The Company’s costs as a lessee for the three months ended March 31, 2024 and 2023 were as follows (in thousands): Three Months Ended March 31, 2024 2023 Operating lease costs $ 2,098 $ 1,367 Variable costs 544 (271) Short term lease costs 101 25 Total lease costs $ 2,743 $ 1,121 Supplemental cash flow information for the three months ended March 31, 2024 and 2023 were as follows: Three Months Ended March 31, Other information 2024 2023 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows from operating leases (in thousands) $ 1,725 $ 1,296 The weighted average remaining lease term and weighted average discount rate of operating leases at March 31, 2024 and 2023 were as follows: Three Months Ended March 31, 2024 2023 Weighted-average remaining lease term - operating leases 16.0 years 11.9 years Weighted-average discount rate - operating leases 7.44 % 6.87 % |
Lease Maturity Schedule | The maturities of operating lease liabilities as of March 31, 2024 were as follows (in thousands): Remainder of 2024 $ 5,742 2025 6,841 2026 6,610 2027 6,467 2028 5,752 Thereafter 56,536 Total lease payments 87,948 Less: imputed interest (36,612) Present value of lease liabilities $ 51,336 |
Sublease Classification | The following table shows the sublease rental income for the three months ended March 31, 2024 and 2023 (in thousands): Three Months Ended March 31, Sublease rental income 2024 2023 Sublease rental income (included in other (expenses) income, net) $ 62 $ 59 Total sublease rental income $ 62 $ 59 |
Lease Receivable Maturity Schedule | Future fixed receipts for non-cancellable operating subleases in effect as of March 31, 2024 are receivable as follows (in thousands): Remainder of 2024 $ 195 2025 $ 260 2026 $ 202 2027 $ 122 2028 $ 105 Total lease payments receivable $ 884 |
Nature of the Business - Narrat
Nature of the Business - Narrative (Details) $ / shares in Units, $ in Millions | 1 Months Ended | ||||||
Feb. 13, 2024 USD ($) $ / shares shares | Feb. 06, 2024 USD ($) $ / shares shares | Nov. 30, 2021 USD ($) | Mar. 31, 2024 USD ($) unit financialInstrument $ / shares | Dec. 31, 2023 $ / shares | Dec. 31, 2022 USD ($) | Nov. 06, 2021 USD ($) | |
Product Information [Line Items] | |||||||
Contract with customer, liability | $ 188.5 | ||||||
Number of freestanding financial instruments | financialInstrument | 1 | ||||||
Units of accounting | unit | 4 | ||||||
BioNTech | |||||||
Product Information [Line Items] | |||||||
Collaborative agreement, period to acquire beneficial ownership from execution date | 5 years | ||||||
Ordinary Shares | |||||||
Product Information [Line Items] | |||||||
Stock par value (usd/gbp per share) | $ / shares | $ 0.000042 | $ 0.000042 | |||||
Number of shares issued in transaction (in shares) | shares | 33,333,333 | ||||||
Per share price of issuance (usd per share) | $ / shares | $ 6 | ||||||
Proceeds of issuance of ordinary shares, net of issuance costs | $ 193.8 | ||||||
Ordinary Shares | BioNTech | |||||||
Product Information [Line Items] | |||||||
Collaborative arrangement, rights and obligations, maximum share purchase requirement, shares (in shares) | shares | 15,000,000 | ||||||
Collaborative arrangement, rights and obligations, maximum share purchase requirement, value | $ 20 | ||||||
Collaborative agreement, beneficial ownership percentage, threshold (in percent) | 0.30 | ||||||
Blackstone Collaboration Agreement | |||||||
Product Information [Line Items] | |||||||
Number of freestanding financial instruments | financialInstrument | 4 | ||||||
Blackstone | Blackstone Collaboration Agreement | |||||||
Product Information [Line Items] | |||||||
Contract with customer, liability | $ 35 | ||||||
Contract with customer, liability gross | $ 50 | ||||||
Remaining performance obligation, variable consideration amount | $ 30 | ||||||
Blackstone | Affiliated Entity | |||||||
Product Information [Line Items] | |||||||
Contract with customer, liability gross | 50 | ||||||
Remaining performance obligation, variable consideration amount | $ 100 | ||||||
Blackstone | Affiliated Entity | Obe-cel Product | |||||||
Product Information [Line Items] | |||||||
Contract with customer, liability gross | $ 40 | ||||||
Remaining performance obligation, variable consideration amount | $ 100 | ||||||
BioNTech | |||||||
Product Information [Line Items] | |||||||
Collaborative arrangement, period to enter agreement from initial closing date (in months) | 18 months | ||||||
Collaborative agreement, sale of stock prohibited without registrant's approval, period (in months) | 6 months | ||||||
BioNTech | License And Options | |||||||
Product Information [Line Items] | |||||||
Contract with customer, liability | $ 10 | ||||||
Revenue, remaining performance obligation, maximum consideration, amount | 582 | ||||||
Remaining performance obligation, variable consideration amount | $ 32 | ||||||
BioNTech | Ordinary Shares | |||||||
Product Information [Line Items] | |||||||
Stockholders' equity, common stock, conversion ratio | shares | 1 | ||||||
Stock par value (usd/gbp per share) | $ / shares | $ 0.000042 |
Nature of the Business - Units
Nature of the Business - Units of Accounting (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) unit | |
Class of Stock | |
Units of accounting | unit | 4 |
BioNTech | |
Class of Stock | |
Payment of equity issuance costs | $ (8.3) |
BioNTech | Investor | |
Class of Stock | |
Amounts of related party transaction | 250 |
BioNTech | Investor | Estimate of Fair Value Measurement | |
Class of Stock | |
Amounts of related party transaction | 250 |
Allocated consideration based on relative fair value | 250 |
Net allocated consideration based on relative fair value after transaction costs | 241.7 |
BioNTech | Initial ADSs, representing ordinary shares | Investor | |
Class of Stock | |
Amounts of related party transaction | 200 |
BioNTech | Initial ADSs, representing ordinary shares | Investor | Estimate of Fair Value Measurement | |
Class of Stock | |
Amounts of related party transaction | 200 |
Allocated consideration based on relative fair value | 200 |
Net allocated consideration based on relative fair value after transaction costs | 193.8 |
BioNTech | Subsequent ADSs, representing ordinary shares | Investor | |
Class of Stock | |
Amounts of related party transaction | 0 |
BioNTech | Subsequent ADSs, representing ordinary shares | Investor | Estimate of Fair Value Measurement | |
Class of Stock | |
Amounts of related party transaction | 0 |
Allocated consideration based on relative fair value | 0 |
Net allocated consideration based on relative fair value after transaction costs | 0 |
BioNTech | BioNTech License and Option Agreement | Investor | |
Class of Stock | |
Amounts of related party transaction | 50 |
BioNTech | BioNTech License and Option Agreement | Investor | Estimate of Fair Value Measurement | |
Class of Stock | |
Amounts of related party transaction | 50 |
Allocated consideration based on relative fair value | 50 |
Net allocated consideration based on relative fair value after transaction costs | 47.9 |
BioNTech | Liabilities related to future royalties and milestones, net (Obe-cel Product Revenue Interest) | Investor | |
Class of Stock | |
Amounts of related party transaction | 40 |
BioNTech | Liabilities related to future royalties and milestones, net (Obe-cel Product Revenue Interest) | Investor | Estimate of Fair Value Measurement | |
Class of Stock | |
Amounts of related party transaction | 40 |
Allocated consideration based on relative fair value | 40 |
Net allocated consideration based on relative fair value after transaction costs | 38.3 |
BioNTech | License Revenue (Binder License) | Investor | |
Class of Stock | |
Amounts of related party transaction | 10 |
BioNTech | License Revenue (Binder License) | Investor | Estimate of Fair Value Measurement | |
Class of Stock | |
Amounts of related party transaction | 10 |
Allocated consideration based on relative fair value | 10 |
Net allocated consideration based on relative fair value after transaction costs | 9.6 |
BioNTech | MCSA | Investor | |
Class of Stock | |
Amounts of related party transaction | 0 |
BioNTech | MCSA | Investor | Estimate of Fair Value Measurement | |
Class of Stock | |
Amounts of related party transaction | 0 |
Allocated consideration based on relative fair value | 0 |
Net allocated consideration based on relative fair value after transaction costs | $ 0 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Accounting Policies [Abstract] | |||
Net loss | $ (52,690) | $ (39,811) | |
Accumulated deficit | (931,252) | $ (878,562) | |
Cash and cash equivalents | 758,529 | 343,027 | $ 239,566 |
Foreign currency gain (loss) | $ (1,700) | $ 800 |
License Revenue - Disaggregatio
License Revenue - Disaggregation of Revenue (Details) - License revenue - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Disaggregation of Revenue [Line Items] | ||
Total license revenue | $ 10,091 | $ 1,292 |
United States | ||
Disaggregation of Revenue [Line Items] | ||
Total license revenue | 0 | 1,292 |
Germany | ||
Disaggregation of Revenue [Line Items] | ||
Total license revenue | $ 10,091 | $ 0 |
License revenue - Narrative (De
License revenue - Narrative (Details) | 3 Months Ended | |||
Jan. 09, 2023 USD ($) | Mar. 31, 2024 USD ($) performanceObligation financialInstrument | Mar. 31, 2023 USD ($) | Feb. 06, 2024 USD ($) | |
Disaggregation of Revenue [Line Items] | ||||
Number of freestanding financial instruments | financialInstrument | 1 | |||
Number of combined performance obligations | performanceObligation | 1 | |||
Distinct performance obligation | performanceObligation | 1 | |||
BioNTech And Cabaletta | Revenue Benchmark | Customer Concentration Risk | ||||
Disaggregation of Revenue [Line Items] | ||||
Concentration risk (in percent) | 100% | 100% | ||
License revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue from contract with customer | $ 10,091,000 | $ 1,292,000 | ||
License revenue | Cabaletta Bio Inc. (“Cabaletta”) | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue from contract with customer | $ 1,200,000 | 0 | $ 1,200,000 | |
License revenue | BioNTech | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue from contract with customer | 10,100,000 | |||
License And Options | BioNTech | ||||
Disaggregation of Revenue [Line Items] | ||||
Remaining performance obligation, variable consideration amount | $ 32,000,000 | |||
Technology Options | BioNTech | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue from contract with customer | $ 10,000,000 |
Interest expense (Details)
Interest expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Banking and Thrift, Interest [Abstract] | ||
Interest expense accrued on liabilities related to future royalties and milestones, net (refer to Note 12) | $ 8,390 | $ 4,905 |
Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) | 10,870 | 0 |
Other interest expense | 9 | 0 |
Total interest expense | $ 19,269 | $ 4,905 |
Net loss per ordinary share - S
Net loss per ordinary share - Schedule of Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Numerator | ||
Net loss | $ (52,690) | $ (39,811) |
Net loss - basic | (52,690) | (39,811) |
Net loss - diluted | $ (52,690) | $ (39,811) |
Denominator | ||
Weighted-average number of ordinary shares used in net loss per share - basic (in shares) | 222,170,707 | 173,825,825 |
Weighted-average number of ordinary shares used in net loss per share - diluted (in shares) | 222,170,707 | 173,825,825 |
Earnings Per Share | ||
Net loss per share - basic (in usd per share) | $ (0.24) | $ (0.23) |
Net loss per share - diluted (in usd per share) | $ (0.24) | $ (0.23) |
Net loss per ordinary share -_2
Net loss per ordinary share - Schedule of Anti-dilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 21,042,674 | 16,731,449 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 45,719 | 382,375 |
Share options | ||
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 17,731,649 | 13,083,768 |
Warrants | ||
Antidilutive Securities | ||
Total potentially dilutive securities (in shares) | 3,265,306 | 3,265,306 |
Fair value measurements (Detail
Fair value measurements (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | $ 589,969 | $ 184,635 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 589,969 | 184,635 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 589,969 | 184,635 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 589,969 | 184,635 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | $ 0 | $ 0 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Research and development claims receivable | $ 22,434 | $ 19,209 |
Prepayments | 11,126 | 8,638 |
VAT receivable | 3,315 | 2,771 |
Accrued interest income | 2,953 | 999 |
Deferred cost | 1,660 | 1,787 |
Withholding tax receivable | 1,582 | 0 |
Other receivables | 736 | 516 |
Lease and lease deposit receivable | 948 | 938 |
Accounts receivable | 0 | 109 |
Total prepaid expenses and other current assets | $ 44,754 | $ 34,967 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of PPE (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment | ||
Less: accumulated depreciation | $ (30,326) | $ (28,774) |
Total property and equipment, net | 33,414 | 34,862 |
Lab equipment | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 41,193 | 32,232 |
Office equipment | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 4,531 | 3,777 |
Furniture and fixtures | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 2,440 | 2,360 |
Leasehold improvements | ||
Property, Plant and Equipment | ||
Property and equipment, gross | 14,218 | 12,728 |
Assets under construction | ||
Property, Plant and Equipment | ||
Property and equipment, gross | $ 1,358 | $ 12,539 |
Property and Equipment, Net - N
Property and Equipment, Net - Narratives (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 1.8 | $ 1.9 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Research and development costs | $ 17,702 | $ 19,825 |
Compensation and benefits | 11,262 | 14,757 |
Professional fees | 8,234 | 4,466 |
Other accrued liabilities | 570 | 533 |
Total accrued expenses and other liabilities | $ 37,768 | $ 39,581 |
Shareholders_ Equity - Narrativ
Shareholders’ Equity - Narrative (Details) $ / shares in Units, $ in Millions | 2 Months Ended | ||||
Feb. 13, 2024 USD ($) $ / shares shares | Feb. 12, 2024 USD ($) $ / shares shares | May 17, 2024 shares | Mar. 31, 2024 vote shares | Feb. 06, 2024 shares | |
Class of Stock | |||||
Voting rights, votes per share | vote | 1 | ||||
Restricted Stock Units (RSUs) | |||||
Class of Stock | |||||
Vested not issued (in shares) | 70,003 | ||||
Restricted Stock Units (RSUs) | Subsequent Event | |||||
Class of Stock | |||||
Shares issued (in shares) | 69,903 | ||||
BioNTech | |||||
Class of Stock | |||||
Collaborative arrangement, period to enter agreement from initial closing date (in months) | 18 months | ||||
Ordinary Shares | |||||
Class of Stock | |||||
Number of shares issued in transaction (in shares) | 33,333,333 | ||||
Per share price of issuance (usd per share) | $ / shares | $ 6 | ||||
Proceeds of issuance of ordinary shares, net of issuance costs | $ | $ 193.8 | ||||
Ordinary Shares | BioNTech | |||||
Class of Stock | |||||
Collaborative arrangement, rights and obligations, maximum share purchase requirement, shares (in shares) | 15,000,000 | ||||
Collaborative arrangement, rights and obligations, maximum share purchase requirement, value | $ | $ 20 | ||||
Ordinary Shares | BioNTech | |||||
Class of Stock | |||||
Stockholders' equity, common stock, conversion ratio | 1 | ||||
Ordinary Shares | Underwriters public offering | |||||
Class of Stock | |||||
Number of shares issued in transaction (in shares) | 58,333,336 | ||||
Per share price of issuance (usd per share) | $ / shares | $ 6 | ||||
Proceeds of issuance of ordinary shares, net of issuance costs | $ | $ 326.8 |
Share-based Compensation - Shar
Share-based Compensation - Share-based Compensation Allocation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | $ 2,284 | $ 2,416 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | 450 | 1,681 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | 1,836 | 727 |
Capitalized | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Total share-based compensation expense | $ (2) | $ 8 |
Share-Based Compensation - Sh_2
Share-Based Compensation - Share Options Rollforward (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding [Roll Forward] | ||
Beginning balance (in shares) | 17,956,385 | |
Granted (in shares) | 654,950 | |
Exercised (in shares) | (102,469) | |
Forfeited (in shares) | (702,716) | |
Expired (in shares) | (74,501) | |
Ending balance (in shares) | 17,731,649 | 17,956,385 |
Exercisable (in shares) | 7,517,388 | |
Vested and expected to vest (in shares) | 17,731,649 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||
Beginning balance weighted average exercise price (usd per share) | $ 5.64 | |
Granted weighted average exercise price (usd per share) | 6.17 | |
Exercised weighted average exercise price (usd per share) | 2.74 | |
Forfeited weighted average exercise price (usd per share) | 3.43 | |
Expired weighted average exercise price (usd per share) | 16.41 | |
Ending balance weighted average exercise price (usd per share) | 5.71 | $ 5.64 |
Exercisable weighted average exercise price (usd per share) | 9.10 | |
Vested and expected to vest weighted average exercise price (usd per share) | $ 5.71 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Additional Disclosures [Abstract] | ||
Weighted average contractual term outstanding | 8 years 1 month 28 days | 8 years 4 months 6 days |
Weighted average contractual term exercisable | 7 years 21 days | |
Weighted average contractual term vested and expected to vest | 8 years 1 month 28 days | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest [Abstract] | ||
Options outstanding, Aggregate Intrinsic Value | $ 45,811 | $ 48,968 |
Options granted, Aggregate Intrinsic Value | 172 | |
Options exercised, Aggregate Intrinsic Value | 315 | |
Options forfeited, Aggregate Intrinsic Value | 2,105 | |
Options expired, Aggregate Intrinsic Value | 13 | |
Options exercisable | 12,223 | |
Options vested and expected to vest | $ 45,811 |
Share-based Compensation - Narr
Share-based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Number of shares modified (in shares) | shares | 571,352 |
Incremental share-based compensation expense | $ 200 |
Intrinsic value of options exercised | $ 315 |
Share options | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Weighted average grant date fair value (usd per share) | $ / shares | $ 4.53 |
Share based compensation not yet recognized for unvested shares vesting period (in years) | 3 years 2 months 26 days |
Share based compensation not yet recognized for unvested shares | $ 12,100 |
Performance Shares | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share based compensation not yet recognized for unvested shares vesting period (in years) | 7 months 17 days |
Share based compensation not yet recognized for unvested shares | $ 2,900 |
Restricted Stock Units (RSUs) | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share based compensation not yet recognized for unvested shares vesting period (in years) | 1 year 9 months 21 days |
Share based compensation not yet recognized for unvested shares other than options (less than) | $ 100 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Stock Units (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2024 $ / shares shares | |
Restricted Stock Units | |
Unvested and outstanding beginning balance (in shares) | shares | 116,436 |
Granted (in shares) | shares | 0 |
Vested (in shares) | shares | (69,903) |
Forfeited (in shares) | shares | (814) |
Unvested and outstanding ending balance (in shares) | shares | 45,719 |
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Unvested and outstanding beginning balance weighted average grant date fair value (usd per share) | $ / shares | $ 3.43 |
Granted weighted average grant date fair value (usd per share) | $ / shares | 0 |
Vested weighted average grant date fair value (usd per share) | $ / shares | 2.61 |
Forfeited weighted average grant date fair value (usd per share) | $ / shares | 6.20 |
Unvested and outstanding ending balance weighted average grant date fair value (usd per share) | $ / shares | $ 4.63 |
Liabilities related to future_3
Liabilities related to future royalties and milestones, net - Schedule of Liability Related to Revenue (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Investments, Debt and Equity Securities [Abstract] | ||
Total Liabilities related to future royalties and milestones, net | $ 228,494 | $ 170,899 |
Liabilities related to future_4
Liabilities related to future royalties and milestones, net - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Dec. 31, 2022 USD ($) payment | Nov. 30, 2021 USD ($) | Mar. 31, 2024 USD ($) financialInstrument | Mar. 31, 2023 USD ($) | Feb. 06, 2024 | Dec. 31, 2023 USD ($) | Nov. 06, 2021 USD ($) | |
Class of Warrant or Right [Line Items] | |||||||
Interest expense accrued on liabilities related to future royalties and milestones, net | $ 8,390 | $ 4,905 | |||||
Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12) | 10,870 | $ 0 | |||||
Number of development payments | payment | 2 | ||||||
Contract with customer, liability | $ 188,500 | ||||||
Number of freestanding financial instruments | financialInstrument | 1 | ||||||
Total Liabilities related to future royalties and milestones, net | $ 228,494 | $ 170,899 | |||||
BioNTech Liability | |||||||
Class of Warrant or Right [Line Items] | |||||||
Interest rate (in percent) | 28.70% | 28.70% | |||||
Strategic Collaboration and Financing Agreement | |||||||
Class of Warrant or Right [Line Items] | |||||||
Interest rate (in percent) | 15.80% | 15.80% | |||||
Blackstone Collaboration Agreement | |||||||
Class of Warrant or Right [Line Items] | |||||||
Number of freestanding financial instruments | financialInstrument | 4 | ||||||
Blackstone | |||||||
Class of Warrant or Right [Line Items] | |||||||
Variable consideration amount, agreement inception | $ 150,000 | ||||||
Blackstone | Blackstone Collaboration Agreement | |||||||
Class of Warrant or Right [Line Items] | |||||||
Contract with customer, liability gross | $ 50,000 | ||||||
Remaining performance obligation, variable consideration amount | $ 30,000 | ||||||
Contract with customer, liability | $ 35,000 | ||||||
Blackstone | Affiliated Entity | |||||||
Class of Warrant or Right [Line Items] | |||||||
Contract with customer, liability gross | 50,000 | ||||||
Remaining performance obligation, variable consideration amount | $ 100,000 | ||||||
Blackstone | Affiliated Entity | Obe-cel Product | |||||||
Class of Warrant or Right [Line Items] | |||||||
Contract with customer, liability gross | $ 40,000 | ||||||
Remaining performance obligation, variable consideration amount | $ 100,000 | ||||||
BioNTech | |||||||
Class of Warrant or Right [Line Items] | |||||||
Total Liabilities related to future royalties and milestones, net | $ 38,300 |
Leases - Narrative (Details)
Leases - Narrative (Details) € in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 USD ($) contract | Oct. 31, 2021 EUR (€) | |
Lessor, Lease, Description [Line Items] | ||
Number of manufacturing properties | contract | 2 | |
Lessor, operating lease, payment to be received | $ | $ 884 | |
Sublease, Lease Term 1 | ||
Lessor, Lease, Description [Line Items] | ||
Lessor, operating lease, payment to be received | € 97 | |
Sublease, Lease Term 2 | ||
Lessor, Lease, Description [Line Items] | ||
Lessor, operating lease, payment to be received | € 109 |
Leases - Lease Cost (Details)
Leases - Lease Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Leases [Abstract] | ||
Operating lease costs | $ 2,098 | $ 1,367 |
Variable costs | 544 | (271) |
Short term lease costs | 101 | 25 |
Total lease costs | 2,743 | 1,121 |
Operating cash outflows from operating leases (in thousands) | $ 1,725 | $ 1,296 |
Weighted-average remaining lease term - operating leases | 16 years | 11 years 10 months 24 days |
Weighted-average discount rate — operating leases (percent) | 7.44% | 6.87% |
Leases - Schedule of Maturity P
Leases - Schedule of Maturity Payments (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Leases [Abstract] | |
Remainder of 2024 | $ 5,742 |
2025 | 6,841 |
2026 | 6,610 |
2027 | 6,467 |
2028 | 5,752 |
Thereafter | 56,536 |
Total lease payments | 87,948 |
Less: imputed interest | (36,612) |
Present value of lease liabilities | $ 51,336 |
Leases - Sublease Classificatio
Leases - Sublease Classification (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Leases [Abstract] | ||
Total sublease rental income | $ 62 | $ 59 |
Leases - Sublease Income Maturi
Leases - Sublease Income Maturity (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Leases [Abstract] | |
Remainder of 2024 | $ 195 |
2025 | 260 |
2026 | 202 |
2027 | 122 |
2028 | 105 |
Total lease payments receivable | $ 884 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Long-term Purchase Commitment [Line Items] | ||
Payments for license fees (less than) | $ 100,000 | |
Loss contingency accrual | 0 | $ 0 |
Miltenyi Biotech B.V. & Co. KG ("Miltenyi") | ||
Long-term Purchase Commitment [Line Items] | ||
Annual license fee | $ 400,000 | |
Capital Addition Purchase Commitments | ||
Long-term Purchase Commitment [Line Items] | ||
Unconditional purchase obligations for capital expenditures | $ 9,900,000 |
Related party transactions - Na
Related party transactions - Narrative (Details) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Feb. 28, 2024 director | Nov. 30, 2021 director | |
Related Party Transaction | ||||
Number of directors | director | 1 | 1 | ||
Contract with customer, liability | $ 188.5 | |||
Accrued interest | 17.6 | |||
Blackstone Collaboration Agreement | ||||
Related Party Transaction | ||||
Carrying amount of liability | 40 | $ 170.9 | ||
Non-cash interest expense, catch-up | $ 1.7 | $ 45 | ||
Blackstone | Autolus | ||||
Related Party Transaction | ||||
Ownership percentage by noncontrolling owners (in percent) | 10% | 10% |