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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of November 2023
Commission File Number: 001-38547
Autolus Therapeutics plc
(Translation of registrant’s name into English)
The MediaWorks
191 Wood Lane
London W12 7FP
United Kingdom
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
x Form 20-F ☐ Form 40-F
INCORPORATION BY REFERENCE
The Company’s Unaudited Condensed Consolidated Interim Financial Statements for the Three Months and Nine Months Ended September 30, 2023, included as Exhibit 99.1 of this Report on Form 6-K (the “Report”) and the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three Months and Nine Months Ended September 30, 2023, included as Exhibit 99.2 of this Report, shall be deemed to be incorporated by reference into the registration statements on Form S-8 (File No. 333-226457), Form S-8 (File No. 333-273776), Form F-3 (File No. 333-258556), Form F-3 (File No. 333-264304), and Form F-3 (File No. 333-264650) of Autolus Therapeutics plc (the "Company") and any related prospectuses, as such registration statements and prospectuses may be amended from time to time, and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently furnished.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Report. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those expressed or implied by these forward-looking statements. For a discussion of risk factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this Report, you should refer to the Company’s filings with the U.S. Securities and Exchange Commission (the "SEC"), including the “Risk Factors” sections contained therein. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this Report.
EXHIBIT INDEX
| | | | | | | | |
Exhibit No. | | Description |
| | |
| | Unaudited Condensed Consolidated Interim Financial Statements for the Three and Nine Months Ended September 30, 2023 |
| | |
| | Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Nine Months Ended September 30, 2023 |
| | |
| | Press release as of November 2, 2023 |
| | |
101 | | The following materials from this Report on Form 6-K are formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months and Nine Months Ended September 30, 2023 and 2022 (Unaudited), (ii) Condensed Consolidated Balance Sheets as at September 30, 2023 (Unaudited) and December 31, 2022, (iii) Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three Months and Nine Months Ended September 30, 2023 and 2022 (Unaudited), (iv) Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2023 and 2022 (Unaudited), and (v) Notes to Condensed Consolidated Financial Statements (Unaudited). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| | | | | | | | | | | | | | |
| | Autolus Therapeutics plc |
| | | |
Date: | November 2, 2023 | By: | /s/ Christian Itin |
| | | Name | Christian Itin, Ph.D. |
| | | Title: | Chief Executive Officer |
Exhibit 99.1
INDEX TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | |
| | Note | | September 30, 2023 | | December 31, 2022 |
Assets | | | | | | |
Current assets: | | | | | | |
Cash and cash equivalents | | | | $ | 256,415 | | | $ | 382,436 | |
Restricted cash | | | | 434 | | | 325 | |
Prepaid expenses and other current assets | | 4 | | 51,533 | | | 43,010 | |
Total current assets | | | | 308,382 | | | 425,771 | |
Non-current assets: | | | | | | |
Property and equipment, net | | 5 | | 34,637 | | | 35,209 | |
Prepaid expenses and other non-current assets | | | | 136 | | | 2,176 | |
Operating lease right-of-use assets, net | | | | 59,403 | | | 23,210 | |
Long-term deposits | | | | 943 | | | 1,832 | |
Deferred tax asset | | | | 2,597 | | | 2,076 | |
| | | | | | |
Total assets | | | | $ | 406,098 | | | $ | 490,274 | |
Liabilities and shareholders' equity | | | | | | |
Current liabilities: | | | | | | |
Accounts payable | | | | $ | 661 | | | $ | 531 | |
Accrued expenses and other liabilities | | 6 | | 31,388 | | | 40,797 | |
Operating lease liabilities, current | | | | 5,491 | | | 5,038 | |
Total current liabilities | | | | 37,540 | | | 46,366 | |
Non-current liabilities: | | | | | | |
Operating lease liabilities, non-current | | | | 46,967 | | | 19,218 | |
Liability related to future royalties and sales milestones, net | | 10 | | 140,778 | | | 125,900 | |
Other long-term payables | | | | 295 | | | 116 | |
Total liabilities | | | | 225,580 | | | 191,600 | |
| | | | | | |
Commitments and contingencies | | 12 | | | | |
| | | | | | |
Shareholders' equity: | | | | | | |
Ordinary shares, $0.000042 par value; 290,909,783 shares authorized as of September 30, 2023 and December 31, 2022; 173,936,794 and 173,074,510, shares issued and outstanding at September 30, 2023 and December 31, 2022 | | | | 8 | | | 8 | |
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at September 30, 2023 and December 31, 2022 | | | | — | | | — | |
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at September 30, 2023 and December 31, 2022 | | | | 118 | | | 118 | |
Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at September 30, 2023 and December 31, 2022 | | | | — | | | — | |
Additional paid-in capital | | | | 1,015,577 | | | 1,007,625 | |
Accumulated other comprehensive loss | | | | (33,794) | | | (38,898) | |
Accumulated deficit | | | | (801,391) | | | (670,179) | |
Total shareholders' equity | | | | 180,518 | | | 298,674 | |
Total liabilities and shareholders' equity | | | | $ | 406,098 | | | $ | 490,274 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(In thousands, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Three Months Ended September 30, | | Nine Months Ended September 30, | |
| | Note | | 2023 | | 2022 | | 2023 | | 2022 | |
Grant income | | | | $ | — | | | $ | — | | | $ | — | | | $ | 166 | | |
License revenue | | 3 | | 406 | | | 2,369 | | | 1,698 | | | 2,369 | | |
| | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | |
Research and development | | | | (37,237) | | | (37,632) | | | (105,323) | | | (109,806) | | |
General and administrative | | | | (10,611) | | | (8,231) | | | (31,017) | | | (24,487) | | |
Loss on disposal of property and equipment | | | | — | | | — | | | (3,791) | | | — | | |
Impairment of operating lease right-of-use assets and related property and equipment | | | | (382) | | | — | | | (382) | | | — | | |
Total operating expenses, net | | | | (47,824) | | | (43,494) | | | (138,815) | | | (131,758) | | |
| | | | | | | | | | | |
Other expenses, net | | | | (1,597) | | | (3,740) | | | (333) | | | (4,214) | | |
Interest income | | | | 3,646 | | | 165 | | | 10,495 | | | 282 | | |
Interest expense | | | | (5,014) | | | (1,850) | | | (14,939) | | | (5,448) | | |
Total other expense, net | | | | (2,965) | | | (5,425) | | | (4,777) | | | (9,380) | | |
Net loss before income tax | | | | (50,789) | | | (48,919) | | | (143,592) | | | (141,138) | | |
Income tax benefit | | | | 4,940 | | | 6,152 | | | 12,380 | | | 19,250 | | |
Net loss attributable to ordinary shareholders | | | | (45,849) | | | (42,767) | | | (131,212) | | | (121,888) | | |
Other comprehensive (loss) income: | | | | | | | | | | | |
Foreign currency exchange translation adjustment | | | | (5,837) | | | (14,054) | | | 5,104 | | | (38,994) | | |
Total comprehensive loss | | | | $ | (51,686) | | | $ | (56,821) | | | $ | (126,108) | | | $ | (160,882) | | |
| | | | | | | | | | | |
Basic and diluted net loss per ordinary share | | 9 | | $ | (0.26) | | | $ | (0.47) | | | $ | (0.75) | | | $ | (1.34) | | |
Weighted-average basic and diluted ordinary shares | | 9 | | 173,984,101 | | | 91,240,801 | | | 173,890,666 | | | 91,028,562 | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)
(In thousands, except share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders' Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
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Balance at June 30, 2023 | 173,680,872 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,012,709 | | | $ | (27,957) | | | $ | (755,542) | | | $ | 229,336 | |
Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 2,864 | | | — | | | — | | | 2,864 | |
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Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | 253,851 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Exercise of share options | 2,071 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 4 | | | — | | | — | | | 4 | |
Unrealized loss on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (5,837) | | | — | | | (5,837) | |
Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (45,849) | | | (45,849) | |
Balance at September 30, 2023 | 173,936,794 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,015,577 | | | $ | (33,794) | | | $ | (801,391) | | | $ | 180,518 | |
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|
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders' Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
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Balance at June 30, 2022 | 90,909,783 | | | $ | 4 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 848,370 | | | $ | (33,510) | | | $ | (600,461) | | | $ | 214,521 | |
Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 3,337 | | | — | | | — | | | 3,337 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Vesting of restricted stock unit awards | 76,804 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Exercise of share options | 145,769 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 117 | | | — | | | — | | | 117 | |
Unrealized loss on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (14,054) | | | — | | | (14,054) | |
Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (42,767) | | | (42,767) | |
Balance at September 30, 2022 | 91,132,356 | | | $ | 4 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 851,824 | | | $ | (47,564) | | | $ | (643,228) | | | $ | 161,154 | |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)
(In thousands, except share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders' Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
Balance at December 31, 2022 | 173,074,510 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,007,625 | | | $ | (38,898) | | | $ | (670,179) | | | $ | 298,674 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 7,948 | | | — | | | — | | | 7,948 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Vesting of restricted stock unit awards net of shares withheld to cover tax withholding | 860,213 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
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Exercise of share options | 2,071 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 4 | | | — | | | — | | | 4 | |
Unrealized gain on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 5,104 | | | — | | | 5,104 | |
Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (131,212) | | | (131,212) | |
Balance at September 30, 2023 | 173,936,794 | | | $ | 8 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 1,015,577 | | | $ | (33,794) | | | $ | (801,391) | | | $ | 180,518 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Ordinary Shares | | Deferred Shares | | Deferred B Shares | | Deferred C Shares | | Additional Paid in Capital | | Accumulated other comprehensive loss | | Accumulated deficit | | Total Shareholders' Equity |
| Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | Shares | | Amount | | | | |
Balance at December 31, 2021 | 90,907,830 | | | $ | 4 | | | 34,425 | | $ | — | | | 88,893,548 | | $ | 118 | | | 1 | | $ | — | | | $ | 843,108 | | | $ | (8,570) | | | $ | (521,340) | | | $ | 313,320 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Share-based compensation expense | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 8,599 | | | — | | | — | | | 8,599 | |
| | | | | | | | | | | | | | | | | | | | | | | |
Vesting of restricted stock unit awards | 76,804 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
Exercise of share options | 147,722 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | 117 | | | — | | | — | | | 117 | |
Unrealized loss on foreign currency translation | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (38,994) | | | — | | | (38,994) | |
Net loss | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | — | | | (121,888) | | | (121,888) | |
Balance at September 30, 2022 | 91,132,356 | | | $ | 4 | | | 34,425 | | | $ | — | | | 88,893,548 | | | $ | 118 | | | 1 | | | $ | — | | | $ | 851,824 | | | $ | (47,564) | | | $ | (643,228) | | | $ | 161,154 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In thousands)
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
Cash flows from operating activities: | | | |
Net loss | $ | (131,212) | | | $ | (121,888) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation and amortization | 4,790 | | | 5,773 | |
Share-based compensation net of amounts capitalized | 7,929 | | | 8,599 | |
Interest expense accrued on liability related to future royalties and sales milestones, net | 14,878 | | | 5,427 | |
Foreign exchange differences | (366) | | | 10,537 | |
Loss on termination of operating lease | 95 | | | — | |
Loss on disposal of property and equipment | 3,812 | | | — | |
Impairment of operating lease right-of-use assets and related property and equipment | 382 | | | — | |
Deferred income tax | (520) | | | (587) | |
| | | |
Changes in operating assets and liabilities: | | | |
Prepaid expenses and other current assets | (7,655) | | | (20,809) | |
Non-current prepaid expenses and other non-current assets | 1,932 | | | 301 | |
Long-term deposits | 937 | | | (5) | |
Accounts payable | 69 | | | (87) | |
Accrued expenses and other liabilities | (6,823) | | | 15,469 | |
Current and non-current operating lease liabilities, net of operating lease right of use assets | (9,002) | | | (472) | |
| | | |
Net cash used in operating activities | (120,754) | | | (97,742) | |
Cash flows from investing activities: | | | |
Purchases of property and equipment | (9,509) | | | (10,208) | |
Net cash used in investing activities | (9,509) | | | (10,208) | |
Cash flows from financing activities: | | | |
| | | |
Proceeds from the exercise of share options | 4 | | | 117 | |
Payments of equity issuance costs | (910) | | | (16) | |
Net cash (used in) provided by financing activities | (906) | | | 101 | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 5,257 | | | (39,459) | |
Net decrease in cash, cash equivalents and restricted cash | (125,912) | | | (147,308) | |
Cash, cash equivalents and restricted cash, beginning of period | 382,761 | | | 310,676 | |
Cash, cash equivalents and restricted cash, end of period | $ | 256,849 | | $ | 163,368 | |
| | | |
Supplemental non-cash flow information | | | |
Property and equipment purchases included in accounts payable and accrued expenses | $ | 1,389 | | | $ | 1,219 | |
Right-of-use assets obtained in exchange for operating lease liabilities | $ | 41,211 | | | $ | 57 | |
Right of use assets terminated and obtained in exchange for operating lease liabilities, net | $ | (1,110) | | | $ | — | |
Capitalized implementation costs included in accrued expenses | $ | 74 | | | $ | 31 | |
| | | |
Capitalized share-based compensation | $ | 19 | | | $ | — | |
| | | |
| | | |
Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets: | | | |
Cash and cash equivalents | $ | 256,415 | | | $ | 163,053 | |
Restricted cash | 434 | | | 315 | |
Total cash, cash equivalents and restricted cash | $ | 256,849 | | | $ | 163,368 | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited)
Note 1. Nature of the Business
Autolus Therapeutics plc (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 cancer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.
The Company is subject to risks and uncertainties common to early-stage 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. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from its product sales.
The Company has funded its operations primarily with proceeds from the sale of equity securities through public offerings and sales pursuant to the Company's at-the-market facility, government grants, U.K. research and development tax credits and receipts from the U.K.'s Research and Development Expenditure Credit program ("RDEC"), out-licensing arrangements and strategic collaboration agreements.
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include those of the Company and its wholly owned subsidiaries, Autolus Holdings (UK) Limited, Autolus Limited, Autolus Inc. and Autolus GmbH, and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated upon consolidation. The significant accounting policies used in 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 20-F for the year ended December 31, 2022 as filed with the Securities and Exchange Commission on March 7, 2023 (the “Annual Report”).
In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, 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, 2022, included in the Annual Report.
The Company has incurred recurring losses since its inception, including net losses of $45.8 million and $42.8 million for the three months ended September 30, 2023 and 2022, respectively and $131.2 million and $121.9 million for the nine months ended September 30, 2023 and 2022, respectively. The Company had an accumulated deficit of $801.4 million and $670.2 million as of September 30, 2023 and December 31, 2022, 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 September 30, 2023 of $256.4 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 the going concern basis.
Foreign Currency Translation
The reporting currency of the Company is the U.S. dollar. The Company has determined the functional currency of the ultimate parent company, Autolus Therapeutics plc, is Pound Sterling. The functional currency of subsidiary operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the 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.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
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 losses of $1.7 million and $3.8 million for the three months ended September 30, 2023 and 2022, respectively, and foreign exchange losses of $0.4 million and $4.4 million for the nine months ended September 30, 2023 and 2022, respectively, which are included in other (expenses) income, net in the unaudited condensed consolidated statements of operations and comprehensive loss.
Use of Estimates
Lease Term—Impact on Right-of-Use Assets and Lease Liabilities
In September 2021, the Company entered into an arrangement for lease with Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of the Company's new 70,000 square foot commercial manufacturing facility, referred to as, The Nucleus, in Stevenage, United Kingdom. Under this arrangement, the landlord leased the facility to the Company on agreed terms, upon satisfaction of certain conditions and completion of construction. Since November 2022, the landlord has handed over various portions of the facility to the Company until July 31, 2023 when the landlord and the Company accepted practical completion of The Nucleus. The Company was required to pay a pro-rated license fee for each portion of the facility which the Company has been granted access until execution of the lease agreement. As the landlord provided the Company with access to portions of the facility, the definition of a lease in accordance with ASC 842, was met. The lease term can materially impact the value of the right of use assets and lease liabilities recorded on our balance sheet as required under ASC 842.
On September 19, 2023, the Company entered into a 20 year lease agreement with Forge Life Sciences Nominee for The Nucleus. The Company calculated the lease term for The Nucleus by taking into account, the noncancellable period specified in the agreement together with the periods a license fee was payable by the Company to the landlord for portions of The Nucleus handed over to the Company.
Recent Accounting Pronouncements Not Yet Adopted
There are no new accounting pronouncements that have been issued by the Financial Accounting Standards Board, “FASB”, that are applicable to the Company.
Note 3. License Revenue
Revenue comprised of license revenue for the three and nine months ended September 30, 2023, and 2022 and is represented in the table below by geographical location (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2023 | | 2022 | | 2023 | | 2022 |
License revenue | | | | | | | | |
United Kingdom | | $ | 346 | | | $ | 60 | | | $ | 346 | | | $ | 60 | |
United States | | $ | 60 | | | $ | 2,309 | | | $ | 1,352 | | | $ | 2,309 | |
Total license revenue | | $ | 406 | | | $ | 2,369 | | | $ | 1,698 | | | $ | 2,369 | |
Research, 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, “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 hereunder 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.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
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. No license revenue was recognized related to the Cabaletta Agreement for the three months ended September 30, 2023. The Company recognized total license revenue of $1.2 million, related to the Cabaletta Agreement for the nine months ended September 30, 2023.
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 September 30, 2023.
Research, Option and License Agreement with an Investee of Syncona Portfolio Limited
The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the three and nine months ended September 30, 2023, Company received variable consideration arising from the achievement of a development milestone amounting to $0.35 million. Consequently, the Company recognized license revenue of $0.35 million (net of foreign exchange differences).
Research, Option and License Agreement with Moderna:
On June 22, 2021, the Company entered into a Research, Option and License Agreement (the “Moderna Agreement”) with ModernaTX, Inc. (“Moderna”), pursuant to which the Company granted to Moderna an exclusive research license to perform research and pre-clinical development activities relating to target sequences with respect to certain of the Company’s research targets and products.
During the three and nine months ended September 30, 2022, Moderna exercised its option, pursuant to the terms of the Moderna Agreement, to license the Company’s proprietary binders against an undisclosed immuno-oncology target for the development and commercialization of mRNA therapeutics resulting in the Company recognizing $2.2 million (net of foreign exchange differences).
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 September 30, 2023. For further details on the terms and accounting treatment considerations for the Moderna Agreement, please refer to Note 3, "Revenue" to the Company's consolidated financial statements contained in Company's Annual Report filed on March 7, 2023.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 4. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, | | December 31, |
| 2023 | | 2022 |
Research and development claims receivable | $ | 37,111 | | | $ | 24,685 | |
Prepayments | 7,535 | | | 12,337 | |
VAT receivable | 2,327 | | | 2,701 | |
Other receivable | 2,357 | | | 1,469 | |
Deferred cost | 1,911 | | | 1,494 | |
Other assets | 127 | | | 203 | |
Accounts receivable | 165 | | | 121 | |
Total prepaid expenses and other current assets | $ | 51,533 | | | $ | 43,010 | |
Note 5. Property and Equipment, Net
Property and equipment, net consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, | | December 31, |
| 2023 | | 2022 |
Lab equipment | $ | 26,362 | | | $ | 31,188 | |
Office equipment | 4,416 | | | 3,573 | |
Furniture and fixtures | 1,982 | | | 1,221 | |
Leasehold improvements | 12,655 | | | 13,583 | |
Assets under construction | 18,239 | | | 13,186 | |
Less: accumulated depreciation | (29,017) | | | (27,542) | |
Total property and equipment, net | $ | 34,637 | | | $ | 35,209 | |
Depreciation expense for the three months ended September 30, 2023 and 2022 was $1.4 million and $1.8 million, respectively, and for the nine months ended September 30, 2023 and 2022 was $4.8 million and $5.7 million, respectively.
Note 6. Accrued Expenses and Other Liabilities
Accrued expenses and other liabilities consisted of the following (in thousands):
| | | | | | | | | | | |
| September 30, | | December 31, |
| 2023 | | 2022 |
Research and development costs | $ | 17,863 | | | $ | 26,478 | |
Compensation and benefits | 10,169 | | | 10,181 | |
Professional fees | 2,873 | | | 3,745 | |
| | | |
Other liabilities | 483 | | | 393 | |
Total accrued expenses and other liabilities | $ | 31,388 | | | $ | 40,797 | |
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Note 7. 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 September 30, 2023, the Company has not declared any dividends.
December 2022 Public Offering
In December 2022, the Company completed an underwritten public offering of 81,927,012 ADSs representing 81,927,012 ordinary shares, which includes the partial exercise by the underwriters of an option to purchase an additional 6,927,012 ADSs, at a public offering price of $2.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $152.4 million.
Restricted stock units
At September 30, 2023, 56,269 ordinary shares underlying restricted stock unit awards have vested, however, these restricted stock unit awards have not been issued and, as such are not included in the calculation of the Company's outstanding shares at September 30, 2023. Subsequent to September 30, 2023, 52,363 ordinary shares underlying restricted stock unit awards have been issued.
Note 8. Share-based Compensation Expense
Share-based compensation expense recorded as research and development expenses, general and administrative expenses and capitalized is as follows (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Research and development | $ | 1,525 | | | $ | 1,831 | | | $ | 4,982 | | | $ | 4,802 | |
General and administrative | 1,335 | | | 1,506 | | | 2,947 | | | 3,797 | |
Capitalized | 4 | | | — | | | 19 | | | — | |
Total share-based compensation | $ | 2,864 | | | $ | 3,337 | | | $ | 7,948 | | | $ | 8,599 | |
Note 9. Net loss per share
Basic and diluted net loss per share attributable to ordinary shareholders was calculated as follows (in thousands, except share and per share amounts):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | Nine Months Ended September 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Numerator | | | | | | | |
Net loss | $ | (45,849) | | | $ | (42,767) | | | $ | (131,212) | | | $ | (121,888) | |
Net loss attributable to ordinary shareholders - basic and diluted | $ | (45,849) | | | $ | (42,767) | | | $ | (131,212) | | | $ | (121,888) | |
| | | | | | | |
Denominator | | | | | | | |
Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 173,984,101 | | | 91,240,801 | | | 173,890,666 | | | 91,028,562 | |
Basic and diluted net loss per ordinary share | $ | (0.26) | | | $ | (0.47) | | | $ | (0.75) | | | $ | (1.34) | |
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
For all periods presented, outstanding but unvested restricted shares 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 and Nine Months Ended September 30, |
| 2023 | | 2022 |
Unvested restricted shares and units | 264,326 | | | 996,927 | |
Share options | 14,074,842 | | | 10,421,137 | |
Warrants | 3,265,306 | | | 3,265,306 | |
Total potentially dilutive securities | 17,604,474 | | | 14,683,370 | |
Note 10. Liability related to future royalties and sales milestones, net
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 8, “Liability related to future royalties and sales milestones, net”
•Note 9, "Warrants"
•Note 10, "Shareholders' equity"
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 relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (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 September 30, 2023 and December 31, 2022, respectively.
On a quarterly basis, the Company assesses the amount and timing of expected royalty and sales milestone payments 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 Blackstone Collaboration Agreement liability using the catch-up method. During the three and nine months ended September 30, 2023, there have been no changes to the estimates used in the determination of the carrying amount of the Blackstone Collaboration Agreement liability.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
There are a number of factors that could materially affect the probability, amount and timing of royalty and sales milestone payments to be made by the Company and Blackstone Development payment to be received from Blackstone, respectively, most of which are not within the Company’s control. The Blackstone Collaboration Agreement liability is recognized using significant unobservable inputs. These inputs are derived using internal management estimates developed based on third party data and reflect management’s judgements, current market conditions surrounding competing products, and forecasts. The significant unobservable inputs include regulatory approvals, estimated patient populations, 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.
Changes to the Blackstone Collaboration Agreement liability related to future royalties and sales milestones are as follows:
| | | | | | | | | | | |
| | | Amount in thousands |
| | | |
| | |
| | |
Balance at December 31, 2021 | | | $ | 47,016 | |
Proceeds from Blackstone Development Payments received | | 70,000 | |
Interest expense accrued on liability related to future royalties and sales milestones, net | | 8,005 | |
Cumulative catch-up adjustment | | 879 | |
Balance at December 31, 2022 | | | $ | 125,900 | |
Interest expense accrued on liability related to future royalties and sales milestones, net | | 14,878 | |
Balance at September 30, 2023 | | | $ | 140,778 | |
During the three months ended September 30, 2023 and 2022 interest expense accrued on liability related to future royalties and sales milestones, net amounted to $5.0 million and $1.8 million, respectively. During the nine months ended September 30, 2023 and 2022 interest expense accrued on liability related to future royalties and sales milestones, net amounted to $14.9 million and $5.4 million, respectively.
11. Leases
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.
Operating Leases
In September 2017, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through May 2021, at which time the Company had the option to renew or terminate the lease. The lease had a six-month rent-free period. In December 2018, the Company executed an additional lease arrangement for additional manufacturing space for a term through September 2023, at which time the Company has the option to renew or terminate the lease. In addition, in May 2020, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through April 2024. In July 2022, the Company and Cell Therapy Catapult Limited mutually agreed: (i) to extend the lease term of a manufacturing suite leased by the Company from April 2024 to February 2025, and (ii) to reduce the lease term of a different manufacturing suite leased by the Company from July 2024 to June 2023. In March 2023, the Company and Cell Therapy Catapult Limited mutually agreed: (i) to terminate the lease relating to the leased manufacturing suite which originally had a lease term until February 2025, (ii) to extend the lease term of one of the remaining manufacturing suites from June 2023 to August 2024, and (iii) to extend the lease term of a third manufacturing suite leased by the Company from September 2023 to August 2024.
The Company recognized a lease termination loss of $0.1 million for the nine months ended September 30, 2023 related to the manufacturing suite terminated and exited on March 31, 2023. In addition, during the nine months ended September 30, 2023, the Company recognized a loss on disposal on leasehold improvements of $3.8 million arising from the manufacturing suite terminated and exited on March 31, 2023.
In October 2018, the Company executed an agreement to sublease office space in Rockville, Maryland for a term through October 2021. The Company then terminated the sublease in February 2020 and immediately entered into a five-year lease for the same space with the landlord. The lease related to this facility is classified as an operating lease.
In January 2019, the Company executed a lease agreement with Whitewood Media Village GP Limited and Whitewood Media Village Nominee Limited to lease the fifth floor of MediaWorks including laboratory space. In August 2021, MediaWorks became the Company's main corporate headquarters. The lease term is nine years and eleven months with an eighteen-month rent free period at the beginning of the lease term. The Company has the option to terminate the lease in November 2026.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
In February 2019, the Company entered into a fifteen-year lease for three manufacturing units in Enfield, United Kingdom with option to terminate the lease in February 2029. In addition to base rent, the Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. In March 2021, one of the units was split into two separate units and the Company surrendered one of the units. Upon the surrender, the Company recognized a $0.1 million gain in other (expense) income after recognizing a termination fee of $0.2 million. The Company has no further obligations for the surrendered unit and the right of use asset and lease liability which were recorded for this unit have been written off in the relevant period. The Company subleased two of the three units to third parties with lease terms ranging from October, 2021 to February 2029 and October 2026, respectively. The Company is actively seeking to sublease or assign the lease arrangements relating to the final unit. The Company completed an asset impairment analysis of the right-of-use lease concluding the undiscounted cash flows exceeded the carrying value as of September 30, 2023.
In September 2021, the Company entered into an arrangement for lease with the landlord, Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of a new 70,000 square foot commercial manufacturing facility in Stevenage, United Kingdom. Under this arrangement, the landlord leased the facility, which will be called The Nucleus, to the Company on agreed terms, upon satisfaction of certain conditions and completion of construction. Since November 2022, the landlord has handed over various portions of the facility to the Company until July 31, 2023 when the landlord and the Company accepted practical completion of The Nucleus. The Company is required to pay a pro-rated license fee for each portion of the facility which the Company has been granted access until the execution of a lease agreement. The Company cumulatively contributed $7.5 million as part as of landlord works and tenant contributions towards the lease as of September 30, 2023 resulting in these payments being taken into account in the determination of the right of use asset for this facility. On July 31, 2023, the landlord and its contractors accepted practical completion of The Nucleus. On September 19, 2023, the Company entered into a 20 year lease agreement with the landlord for The Nucleus. The Company made fit-out costs in other areas of the building and will be required to be removed at the end of the lease term. As a result, as of September 30, 2023, the Company has recognized an estimated Asset Retirement Obligation ("ARO") amounting to $0.1 million.
The following table contains a summary of the lease costs recognized under Accounting Standards Update, "ASU" 2016-02 and other information pertaining to the Company’s operating leases for three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
Lease costs | | 2023 | | 2022 | | 2023 | | 2022 |
Operating lease costs | | $ | 2,061 | | | $ | 1,103 | | | $ | 5,235 | | | $ | 3,542 | |
Variable costs | | 573 | | | 268 | | | 657 | | | 720 | |
Short term lease costs | | 227 | | | 119 | | | 451 | | | 231 | |
Total lease costs | | $ | 2,861 | | | $ | 1,490 | | | $ | 6,343 | | | $ | 4,493 | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | | | | | | | | | | | | | |
| | | | Nine Months Ended September 30, |
Other information | | | | 2023 | | 2022 |
Cash paid for amounts included in the measurement of lease liabilities: | | | | |
Operating cash outflows from operating leases (in thousands) | | $ | 7,817 | | $ | 3,740 |
| | | | |
| | | | | | |
Weighted-average remaining lease term - operating leases (in years) | | 15.9 years | | 5.1 years |
Weighted-average discount rate - operating leases | | 7.44 | % | | 7.18 | % |
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Future fixed payments for non-cancellable operating leases in effect as of September 30, 2023 are payable as follows (in thousands):
| | | | | | | | | | | | | | |
Remainder of 2023 | | | | $ | 1,975 | |
2024 | | | | 8,062 | |
2025 | | | | 6,625 | |
2026 | | | | 6,396 | |
2027 | | | | 6,255 | |
Thereafter | | | | 60,424 | |
Total lease payments | | | | 89,737 | |
Less: imputed interest | | | | (37,279) | |
Present value of lease liabilities | | | | $ | 52,458 | |
Sublease Agreements
In October 2021, the Company entered into two separate sublease agreements with two third parties for two manufacturing spaces in Enfield which are currently leased by the Company. 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. In October 2021, the Company received $0.1 million in rental deposits, arising from the sub-lease agreements which have been classified as restricted cash as of September 30, 2023 and December 31, 2022, respectively. Both subleases have been classified as operating leases. The Company recognized the sublease payments on a straight-line basis from the commencement of the sublease agreements.
The following table shows the sublease rental income for the three and nine months ended September 30, 2023 and 2022 (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
Sublease rental income | | 2023 | | 2022 | | 2023 | | 2022 |
Sublease rental income (included in other income (expenses), net) | | $ | 61 | | | $ | 57 | | | $ | 181 | | | $ | 183 | |
Total sublease rental income | | $ | 61 | | | $ | 57 | | | $ | 181 | | | $ | 183 | |
Future fixed receipts for non-cancellable operating subleases in effect as of September 30, 2023 are receivable as follows (in thousands):
| | | | | | | | |
Remainder of 2023 | | $ | 65 |
2024 | | $ | 261 |
2025 | | $ | 261 |
2026 | | $ | 203 |
2027 | | $ | 123 |
Thereafter | | $ | 106 |
Total lease payments receivable | | $ | 1,019 |
Note 12. Commitments and Contingencies
License Agreements
The Company has entered into an exclusive license agreement with UCL Business Ltd, ("UCLB") which has subsequently been amended and restated. 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 and nine months ended September 30, 2023, less than $0.1 million and $0.2 million was paid or payable to UCLB by the Company, respectively, relating to the income allocable to the value of the sublicensed intellectual property rights.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
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 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.
In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG ("Miltenyi") under which the Company will have the right to develop, manufacture and use Miltenyi's or affiliates' sublicensed 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 in aggregate relating to an upfront license payment and milestone payment which was deemed probable during the three and nine months ended September 30, 2023.
The Company recognizes the regulatory, clinical and commercial milestones when probable. The Company concluded that, as of September 30, 2023, there were no other milestones for which the likelihood of achievement was currently probable relating to either of the UCLB, Noile, Adaptive or Miltenyi contracts.
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 September 30, 2023 and December 31, 2022.
Capital Commitments
As of September 30, 2023, the Company’s unconditional purchase obligations for capital expenditure totaled $4.2 million and include signed orders for capital equipment and capital expenditure for construction and related expenditure relating to its properties in the United Kingdom and the United States.
Blackstone Strategic Collaboration and Financing Agreement
Refer to Note 10, "Liability related to future royalties and sales milestone, net" for further details to the Blackstone Collaboration Agreement.
Leases
Lease payments under operating leases as of September 30, 2023 and information about the Company’s lease arrangements are disclosed in Note 11, "Leases".
Note 13. Related parties
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 their right to nominate one director to the board of directors of the Company.
As of September 30, 2023, the carrying amount of the Blackstone Collaboration Agreement liability was $140.8 million which included aggregated cumulative non-cash interest expense and cumulative catch-up adjustment of $24.9 million. As of December 31, 2022, the carrying amount of the Blackstone Collaboration Agreement liability was $125.9 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $10.0 million. Refer to Note 10, "Liability related to sales of future royalties and sales milestone, net" for further details.
AUTOLUS THERAPEUTICS PLC
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Syncona Portfolio Limited
Syncona Portfolio Limited is a related party of the Company as Syncona Portfolio Limited owns more than 10% of the Company's outstanding voting securities and is therefore one of the principal owners of the Company. In addition, the chair of the ultimate parent company of Syncona Portfolio Limited is also a director of the Company.
December 2022 public offering
In connection with the Company’s December 2022 public offering, certain of the Company's related parties purchased the Company's ADSs from the underwriters at the public offering price of $2.00 per ADSs, and on the same terms as other investors in the Company's public offering. The following table summarizes purchases of ADS by the Company's related parties:
| | | | | | | | | | | | | | |
Related party | | ADSs purchased | | Total purchase price (in millions) |
Syncona Portfolio Limited (1) | | 14,000,000 | | | $ | 28.0 | |
Deep Track Capital, LP (2) | | 15,000,000 | | | 30.0 | |
Qatar Investment Authority (3) | | 15,000,000 | | | 30.0 | |
Armistice Capital, LLC (4) | | 10,000,000 | | | 20.0 | |
Entities affiliated with Blackstone (5) | | 2,500,000 | | | 5.0 | |
| | 56,500,000 | | | $ | 113.0 | |
(1) Syncona Portfolio Limited is a holder of more than 10% of the Company's share capital.
(2) In connection with this transaction, Deep Track Capital, LP became a holder of more than 5% of the Company's share capital.
(3) In connection with this transaction, Qatar Investment Authority became a holder of more than 5% of the Company's share capital.
(4) In connection with this transaction, Armistice Capital, LLC became a holder of more than 5% of the Company's share capital.
(5) Entities affiliated with Blackstone collectively hold more than 10% of the Company's share capital.
Investee of Syncona Portfolio Limited
The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020. In addition, the chair of the ultimate parent company of Syncona Portfolio Limited is also a director of the Company. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the three and nine months ended September 30, 2023, Company received variable consideration arising from the achievement of a development milestone amounting to $0.35 million. Consequently, the Company recognized license revenue of $0.35 million (net of foreign exchange differences).
Note 14. Subsequent Events
The Company evaluated subsequent events through November 2, 2023, the date on which these unaudited condensed consolidated financial statements were issued. The Company has concluded that no subsequent event has occurred that requires disclosure.
Exhibit 99.2
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and the related notes to those statements included as Exhibit 99.1 to this Report on Form 6-K submitted to the Securities and Exchange Commission, or the SEC, on November 2, 2023. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2022 as filed with the Securities and Exchange Commission, or the SEC on March 7, 2023.
We maintain our books and records in pounds sterling, our results are subsequently converted to U.S. dollars, and we prepare our consolidated financial statements in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, as issued by the Financial Accounting Standards Board, or FASB. All references in this Report on Form 6-K to “$” are to U.S. dollars and all references to “£” are to pounds sterling. Our unaudited condensed consolidated statements of operations and comprehensive loss for the three months ended September 30, 2023 and 2022 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2657 and £1.00 to $1.1769, respectively. Our consolidated statements of operations and comprehensive loss and cash flows for the nine months ended September 30, 2023 and 2022 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2439 and £1.00 to $1.2586, respectively. Our unaudited condensed consolidated balance sheet as of September 30, 2023 and audited consolidated balance sheet as of December 31, 2022 have been translated from pounds sterling into U.S. dollars at the rate of £1.00 to $1.2201 and £1.00 to $1.2090, respectively. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as of that or any other date.
Unless otherwise indicated or the context otherwise requires, all references to “Autolus,” the “Company,” “we,” “our,” “us” or similar terms refer to Autolus Therapeutics plc and its consolidated subsidiaries.
The statements in this discussion regarding our expectations regarding our future performance, liquidity and capital resources and other non-historical statements are forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of our Annual Report and any subsequent reports that we file with the SEC.
Overview
We are a biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer and autoimmune diseases. Using our broad suite of proprietary and modular T cell programming technologies, we are engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and attack and kill these cells. We believe our programmed T cell therapies have the potential to be best-in-class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients.
Since our inception, we have incurred significant operating losses. For the nine months ended September 30, 2023 and 2022, we incurred net losses of $131.2 million and $121.9 million, respectively, and had an accumulated deficit of $801.4 million and $670.2 million as of September 30, 2023 and December 31, 2022, respectively.
As of September 30, 2023, we had cash and cash equivalents of $256.4 million. Based on our current clinical development plans, we believe our existing cash and cash equivalents will be sufficient to fund our current and planned operating expenses and capital expenditure requirements through at least the next twelve months from the date of issuance of our unaudited condensed consolidated financial statements.
Recent Developments
Key obecabtagene autoleucel (obe-cel) updates and anticipated milestones:
•Obe-cel in relapsed / refractory (r/r) adult Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia (ALL) – The FELIX Study
◦Longer term follow up data and subgroup analysis data to be presented at the American Society of Hematology (ASH) in December 2023, as well as at medical conferences in the first half of 2024.
◦Biologics License Application (BLA) submission for obe-cel is on track to be submitted to the U.S. Food and Drug Administration (FDA) by the end of 2023 and a submission of a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024.
•Obe-cel in B-cell mediated autoimmune diseases
◦Phase 1 study in refractory systemic lupus erythematosus (SLE) patients is on track to start in early 2024, with initial clinical data expected in late 2024.
Pipeline clinical trials in collaboration with University College London (UCL), updates and anticipated milestones:
•AUTO1/22 in pediatric B-ALL patients – Phase 1 CARPALL Study
◦The data presented at the European Society for Blood and Marrow Transplantation (EBMT) in April 2023 on the AUTO1/22 Phase 1 CARPALL study was published in Blood, in August 2023, entitled ‘CD19/CD22 targeting with co-transduced CAR T-cells to prevent antigen negative relapse after CAR T-cell therapy of B-ALL’.
•AUTO8 in Multiple Myeloma – Phase 1 MCARTY Study
◦AUTO8 is a next-generation product candidate for multiple myeloma, which comprises two CARs for the multiple myeloma targets, BCMA and CD19. In collaboration with UCL, we initiated a study in 2022. Patients continue to be enrolled and initial data is at ASH in December 2023.
•AUTO6NG in Neuroblastoma - Phase 1 MAGNETO Study
◦AUTO6NG contains a CAR that targets GD2 alongside additional programming modules to enhance the activity and persistence. UCL has received Medicines and Health products Regulatory Agency (MHRA) approval for the conduct of a Phase 1 clinical study in children with r/r neuroblastoma. The study will be initiated in Q4 2023.
Key Operational Updates during Q3 2023
◦Our new 70,000 square foot commercial manufacturing facility, The Nucleus, in Stevenage, UK has completed process performance qualification and is on track to support the BLA submission for obe-cel. We estimate capacity of approximately 2,000 batches per annum which is anticipated to be sufficient to meet US and EU adult ALL demand.
Components of Our Results of Operations
Grant Income
Grant income consists of proceeds from government research grants used to perform specific research and development activities. We recognize grant income over the period in which we recognize the related costs covered under the terms and conditions of the grant. We have received grants from the U.K. government, which are repayable under certain circumstances, including breach or noncompliance with the terms of the grant. For grants with refund provisions, we review the grant to determine the likelihood of repayment. If the likelihood of repayment of the grant is determined to be remote, then the grant is recognized as grant income. We have concluded that the likelihood of any repayment events included in our current grants is remote.
License Revenue
We account for our revenue pursuant to the provisions of Accounting Standards Codification, or ASC Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”).
We have no products approved for commercial sale and have not generated any revenue from commercial product sales. The total revenue to date has been generated principally from license agreements. As of September 30, 2023, we have entered into various license agreements which included non-refundable upfront license fees, options for future commercial licenses, payments based upon achievement of clinical development and regulatory objectives, payments based upon achievement of certain levels of product sales, and royalties on product sales.
In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation.
License Fees and Multiple Element Arrangements
If a license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from non-refundable, upfront fees allocated to the license at such time as the license is transferred to the licensee and the licensee is able to use, and benefit from the license. For licenses that are bundled with other promises, we utilize judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.
Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, we consider the nature of the service that we promise to transfer to the customer. When we decide on a method of measurement, we will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances.
Customer options
If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options that are not determined to be material rights are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. We evaluate the customer options for material rights, or options to acquire additional goods or services for free or at a discount. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement. We allocate the transaction price to material rights based on the relative standalone selling price, which is determined based on any identified discount and the probability that the customer will exercise the option. Amounts allocated to a material right are not recognized as revenue until, at the earliest, the option is exercised.
Contingent Research Milestone Payments
ASC Topic 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example.
If the consideration in a contract includes a variable amount, we will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if our entitlement to the consideration is contingent on the occurrence or non-occurrence of a future event. We consider contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period.
We assess whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestone revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant.
U.S. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinate. We consider all relevant factors.
Royalty Revenue
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Operating Expenses
Research and Development Expenses
Research and development expenses consist of costs incurred in connection with the research and development of our product candidates, which are partially offset by U.K. research and development expenditure tax credits provided by His Majesty’s Revenue & Customs, or HMRC. We expense research and development costs as incurred. These expenses include:
•expenses incurred under agreements with contract research organizations, (CROs), as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
•manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials;
•employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;
•expenses incurred for outsourced professional scientific development services;
•costs for laboratory materials and supplies used to support our research activities;
•allocated facilities costs, depreciation and other expenses, which include rent and utilities; and
•upfront, milestone and management fees for maintaining licenses under our third-party licensing agreements.
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers.
Our direct research and development expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside consultants and CROs in connection with our preclinical development, manufacturing and clinical development activities. Our direct research and development expenses by program also include fees incurred under license agreements. We do not allocate employee costs or facility expenses, including depreciation or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified. We use internal resources primarily to oversee research and development as well as for managing our preclinical development, process development, manufacturing and clinical development activities.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially over the next few years as we increase personnel costs, initiate and conduct additional clinical trials and prepare regulatory filings related to our product candidates. We also expect to incur additional expenses related to milestone, royalty payments and maintenance fees payable to third parties with whom we have entered into license agreements to acquire the rights related to our product candidates.
The successful development and commercialization of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from sales of any of our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with development and commercialization activities, including the uncertainty of:
•the scope, progress, outcome and costs of our clinical trials and other research and development activities, including establishing an appropriate safety profile with IND-directed studies;
•successful patient enrollment in, and the initiation and completion of, clinical trials;
•the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
•establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;
•development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial manufacturing;
•obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;
•significant and changing government regulation;
•launching commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others;
•maintaining a continued acceptable safety profile of the product candidates following approval; and
•significant competition and rapidly changing technologies within the biopharmaceutical industry.
We may never succeed in achieving regulatory approval for any of our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others. Any changes in the outcome of any of these variables with respect to the development of our product candidates in clinical development could mean a significant change in the costs and timing associated with the development of these product candidates. For example, if the FDA, the EMA, or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing beyond those that we currently expect or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development of that product candidate. Commercialization of our product candidates can take several years and millions of dollars in development costs.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, related benefits, travel and share-based compensation expense for personnel in executive, finance, legal and other administrative functions. General and administrative expenses also include allocated facility-related costs, patent filing and prosecution costs and professional fees for marketing, insurance, legal, consulting, and accounting and audit services.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support the planned development of our product candidates. Additionally, if we believe a regulatory approval of one of our product candidates appears likely, we anticipate an increase in payroll and third-party expense as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our product candidate.
We have experienced, and expect to continue to experience, increased expense with being a public company, including increased accounting, audit, legal, regulatory and compliance costs associated with maintaining compliance with Nasdaq listing rules and SEC requirements, director and officer insurance premiums, as well as higher investor and public relations costs.
Loss on disposal of property and equipment
Loss on disposal of property and equipment primarily consists of losses arising from the disposal of all categories of property and equipment.
Impairment of operating lease right-of-use assets and related property and equipment
Impairment of operating lease right-of-use assets and related property and equipment consists primarily of impairment losses arising from the impairment of leased properties and leasehold improvements that are currently not be utilized by us.
Other expenses, net
Other income, net consists primarily of foreign currency transaction gains and losses, sublease income and gains or losses arising from the termination of leases. Other expense consists primarily of foreign currency transaction losses.
Interest Income
Interest income consists primarily of interest received from banks and money market funds on our cash and cash equivalents balances. We invest funds in a variety of short-term interest-bearing instruments.
Interest Expense
Interest expense consists primarily of non-cash interest expense arising from amortization of the liability related to future royalties and sales milestones, pursuant to our Collaboration Agreement with Blackstone, using the effective interest rate method. On a quarterly basis, we assess the expected present value of the future Blackstone Development payment which may be received by us and future royalties and sales milestone payments to Blackstone which may be paid by us. To the extent the amount or timing of such receipts or payments is materially different than our previous estimates we record a cumulative catch-up adjustment to the liability related to future royalties and sales milestones. The adjustment to the carrying amount is recognized as an adjustment to finance expense in the period in which the change in estimate occurred.
Income Tax Benefit
We are subject to corporate taxation in the United Kingdom, United States, Germany and Switzerland. Due to the nature of our business, we have generated losses since inception. Our income tax benefit recognized represents the sum of the research and development tax credits recoverable in the United Kingdom and income tax payable in the United States.
As a company that carries out extensive research and development activities, we benefit from the U.K. research and development tax credit regime under the scheme for small or medium-sized enterprises, or SMEs, and also claim a Research and Development Expenditure Credit, or RDEC, to the extent that our projects are grant funded. Under the SME regime, we are able to surrender some of our trading losses that arise from our qualifying research and development activities for a cash rebate of up to 33.35% of such qualifying research and development expenditure. The UK Government recently enacted changes which reduce the potential cash rebate under the SME regime to 18.6% for qualifying expenditure incurred on or after April 1, 2023. Additionally, the U.K Government announced but has not yet enacted further changes to the SME regime which include the introduction of a new rate for R&D intensive companies of 27% (which we currently expect to qualify for) and comes into effect for expenditure incurred after April 1, 2023. We have not accounted for these latest changes in our financial statements as they have not yet been enacted.
The net tax benefit of the RDEC reflected in our unaudited condensed consolidated financial statements was 10.5% for each of the nine months ended September 30, 2023 and 2022. Following recent proposed changes by the UK Government the net tax benefit of the RDEC for qualifying expenditure incurred on or after April 1, 2023 has been increased to 15%. We currently meet the conditions of the SME regime, but also can make claims under the RDEC regime to the extent that our projects are grant funded. We may not be able to continue in the future to qualify as a small or medium-sized enterprise under the SME Program, based on size criteria concerning employee headcount, turnover and gross assets. If we cease to qualify under the SME regime, we may make a claim under the RDEC regime. It should be noted, however, that the types of qualifying expenditure in respect of which we may make claims under the RDEC Program are more restricted than under the SME Program (for example, it may be the case that certain subcontracted costs in respect of which claims may be made under the SME Program do not qualify for relief under the RDEC Program).
Un-surrendered U.K. losses may be carried forward indefinitely to be offset against future taxable profits, subject to numerous utilization criteria and restrictions. The amount that can be offset each year is limited to £5.0 million plus an incremental 50% of United Kingdom taxable profits. After accounting for tax credits receivable, we had accumulated tax losses for carry forward in the U.K. of $320.8 million as of December 31, 2022. No deferred tax assets are recognized on our U.K. losses because there is currently no indication that we will make sufficient taxable profits to utilize these tax losses. We carry a $2.6 million deferred tax asset balance related to the U.S. entity. For the nine months ended September 30, 2023, we have recorded a valuation allowance against the net deferred tax asset where the recoverability due to future taxable profits is unknown. On April 1, 2023 the main rate of the U.K. corporation tax was increased to 25% for companies with profits in excess of £250,000, or the small profits rate of 19% for companies with profits of £50,000 or less (with marginal relief from the main rate available to companies with profits between £50,000 and £250,000).
In the event we generate revenues in the future, we may benefit from the United Kingdom “patent box” regime that allows profits attributable to revenues from patents or patented products to be taxed at an effective rate of 10%.
Value Added Tax, or VAT, is broadly charged on all taxable supplies of goods and services by VAT-registered businesses. Under current rates, an amount of 20% of the value, as determined for VAT purposes, of the goods or services supplied is added to all sales invoices and is payable to HMRC. Similarly, VAT paid on purchase invoices is generally reclaimable from HMRC.
Results of Operations
Comparison of Three Months Ended September 30, 2023 and 2022
The following table summarizes our results of operations for the three months ended September 30, 2023, and 2022 (in thousands):
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | |
| 2023 | | 2022 | | Change |
| | | | | |
License revenue | $ | 406 | | | $ | 2,369 | | | $ | (1,963) | |
Operating expenses: | | | | | |
Research and development | (37,237) | | | (37,632) | | | 395 | |
General and administrative | (10,611) | | | (8,231) | | | (2,380) | |
| | | | | |
Impairment of operating lease right-of-use assets and related property and equipment | (382) | | | — | | | (382) | |
Total operating expenses, net | (47,824) | | | (43,494) | | | (4,330) | |
| | | | | |
Other expenses, net | (1,597) | | | (3,740) | | | 2,143 | |
Interest income | 3,646 | | | 165 | | | 3,481 | |
Interest expense | (5,014) | | | (1,850) | | | (3,164) | |
Total other expense, net | (2,965) | | | (5,425) | | | 2,460 | |
Net loss before income tax | (50,789) | | | (48,919) | | | (1,870) | |
Income tax benefit | 4,940 | | | 6,152 | | | (1,212) | |
Net loss attributable to ordinary shareholders | $ | (45,849) | | | $ | (42,767) | | | $ | (3,082) | |
License Revenue
License revenue amounting to $0.4 million for the three months ended September 30, 2023 primarily relates to revenue recognized arising from an existing license agreement with an investee of Syncona Portfolio Limited, which is a holder of more than 10% of our share capital. License revenue amounting to $2.4 million for the three months ended September 30, 2022 primarily relates to ModernaTX Inc. ("Moderna") exercising its option to license certain of our technology.
The following tables provide additional detail on our research and development expenses (in thousands):
| | | | | | | | | | | | | | | | | |
| Three Months Ended September 30, | | |
| 2023 | | 2022 | | Change |
Direct research and development expenses |
| |
| |
|
B cell malignancies (Obe-cel, AUTO1/22 & AUTO3) | $ | 4,779 | |
| $ | 13,487 | |
| $ | (8,708) | |
Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8) | 761 | | | 398 | | | 363 | |
Total direct research and development expense | $ | 5,540 | | | $ | 13,885 | | | $ | (8,345) | |
| | | | | |
Indirect research and development expenses and unallocated costs: |
| |
| |
|
Personnel related (including share-based compensation) | $ | 15,603 | | | $ | 13,859 | | | 1,744 | |
Indirect research and development expense | 16,094 | | | 9,888 | | | 6,206 | |
Total research and development expenses | $ | 37,237 | |
| $ | 37,632 | |
| $ | (395) | |
Research and development expenses decreased by $0.4 million to $37.2 million for the three months ended September 30, 2023 from $37.6 million for the three months ended September 30, 2022 primarily due to:
•a decrease of $4.8 million in clinical costs and manufacturing costs primarily relating to our obe-cel clinical product candidate,
•a decrease of $0.5 million in depreciation and amortization related to property, plant and equipment and intangible assets,
•a decrease of $0.5 million in professional consulting and legal fees in relation to our research and development activities,
•a decrease of $0.2 million related to general office expenses, offset by:
•an increase of $3.2 million in facilities costs related to our new manufacturing facility, The Nucleus, in Stevenage, United Kingdom as well as increases in costs related to maintaining our current leased properties,
•an increase of $1.7 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities, and
•an increase of $0.7 million related to information technology infrastructure and support for information systems related to our new manufacturing facility.
General and Administrative Expenses
General and administrative expenses increased by $2.4 million to $10.6 million for the three months ended September 30, 2023 from $8.2 million for the three months ended September 30, 2022 primarily due to:
•an increase of $2.0 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
•an increase of $0.4 million related to information technology infrastructure and support for information systems related to the conduct of corporate and commercial operations,
•an increase of $0.3 million in facility costs due to the increase in space utilized for general and administrative activities and related to general office expense,
•an increase of $0.1 million in depreciation and amortization related to property and equipment and intangible assets, offset by:
•a decrease of $0.2 million primarily related to a reduction in directors' and officers' liability insurance premiums, legal and professional fees, and
•a decrease of $0.2 million in costs related to commercial-stage readiness activities.
Impairment of operating lease right-of-use assets and related property and equipment
For the three months ended September 30, 2023, we recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Stevenage, United Kingdom. There was no impairment recognized for the three months ended September 30, 2022.
Other expenses, net
Other expenses, net decreased to $1.6 million for the three months ended September 30, 2023 from $3.7 million for the three months ended September 30, 2022. The decrease of $2.1 million is primarily due to lower foreign exchange losses for the three months ended September 30, 2023 as compared to the three months ended September 30, 2022.
Interest income
Interest income increased to $3.6 million for the three months ended September 30, 2023, as compared to $0.2 million for the three months ended September 30, 2022. The increase in interest income of $3.4 million primarily relates to increase in yield and also higher account balances associated with our cash and cash equivalents during the three months ended September 30, 2023 as compared to the three months ended September 30, 2022.
Interest expense
Interest expense increased to $5.0 million for the three months ended September 30, 2023 as compared to $1.9 million for the three months ended September 30, 2022. Interest expense increased by $3.1 million primarily due to an increase in the balance of the liability for future royalties and sales milestones, net associated with our strategic collaboration agreement with Blackstone.
Income Tax Benefit
Income tax benefit decreased by $1.2 million to $4.9 million for the three months ended September 30, 2023 from $6.2 million for the three months ended September 30, 2022 due to a combination of a decrease in qualifying research and development expenditures, a reduction in effective tax rate related to the U.K. research and development tax credit regime under the scheme for SMEs, partially offset by an adjustment arising from the finalization of our prior year tax returns.
Comparison of Nine Months Ended September 30, 2023 and 2022
The following table summarizes our results of operations for the nine months ended September 30, 2023, and 2022 (in thousands):
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, | | |
| 2023 | | 2022 | | Change |
Grant income | $ | — | | | $ | 166 | | | $ | (166) | |
License revenue | 1,698 | | | 2,369 | | | (671) | |
Operating expenses: | | | | | |
Research and development | (105,323) | | | (109,806) | | | 4,483 | |
General and administrative | (31,017) | | | (24,487) | | | (6,530) | |
Loss on disposal of property and equipment | (3,791) | | | — | | | (3,791) | |
Impairment of operating lease right-of-use assets and related property and equipment | (382) | | | — | | | (382) | |
Total operating expenses, net | (138,815) | | | (131,758) | | | (7,057) | |
| | | | | |
Other expenses, net | (333) | | | (4,214) | | | 3,881 | |
Interest income | 10,495 | | | 282 | | | 10,213 | |
Interest expense | (14,939) | | | (5,448) | | | (9,491) | |
Total other expense, net | (4,777) | | | (9,380) | | | 4,603 | |
Net loss before income tax | (143,592) | | | (141,138) | | | (2,454) | |
Income tax benefit | 12,380 | | | 19,250 | | | (6,870) | |
Net loss attributable to ordinary shareholders | $ | (131,212) | | | $ | (121,888) | | | $ | (9,324) | |
Grant Income
There was no grant income recognized for the nine months ended September 30, 2023 as compared to $0.2 million in reimbursable expenditures for the same period in the prior year.
License Revenue
License revenue decreased by $0.7 million for the nine months ended September 30, 2023. During the nine months ended September 30, 2023, we recognized $1.7 million relating to the execution of the Option and License Agreement with Cabaletta Bio Inc., which included recognition of a non-refundable license fee and license revenue from an investee of Syncona Portfolio Limited, which is a holder of more than 10% of our share capital. During the nine months ended September 30, 2022 license revenue of $2.4 million primarily related to Moderna exercising its option to license certain of our intellectual property.
Research and Development Expenses
The following tables provide additional detail on our research and development expenses (in thousands):
| | | | | | | | | | | | | | | | | |
| Nine Months Ended September 30, | | |
| 2023 | | 2022 | | Change |
Direct research and development expenses |
| |
| |
|
B cell malignancies (Obe-cel, AUTO1/22 & AUTO3) | $ | 12,933 | |
| $ | 34,880 | |
| $ | (21,947) | |
Other projects (AUTO4, AUTO5, AUTO6, AUTO7 & AUTO8) | 2,304 | | | 2,046 | | | 258 | |
Total direct research and development expense | $ | 15,237 | | | $ | 36,926 | | | $ | (21,689) | |
| | | | | |
Indirect research and development expenses and unallocated costs: |
| |
| |
|
Personnel related (including share-based compensation) | $ | 46,485 | | | $ | 40,349 | | | $ | 6,136 | |
Indirect research and development expense | 43,601 | | | 32,531 | | | 11,070 | |
Total research and development expenses | $ | 105,323 | |
| $ | 109,806 | |
| $ | (4,483) | |
Research and development expenses decreased by $4.5 million to $105.3 million for the nine months ended September 30, 2023 from $109.8 million for the nine months ended September 30, 2022 primarily due to:
•a decrease of $15.5 million in clinical costs and manufacturing costs primarily relating to our obe-cel clinical product candidate,
•a decrease of $1.2 million in depreciation and amortization related to property, plant and equipment and intangible assets,
•a decrease of $1.1 million in legal fees and professional consulting fees in relation to our research and development activities,
•a decrease of $0.1 million related to general office expense,
•a decrease of $0.1 million in material transportation costs, offset by:
•an increase of $6.1 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,
•an increase of $5.2 million in facilities costs related to our new manufacturing facility, The Nucleus, in Stevenage, United Kingdom as well as increases in costs related to maintaining our current leased properties, and
•an increase of $2.2 million related to information technology infrastructure and support for information systems related to our new manufacturing facility.
General and Administrative Expenses
General and administrative expenses increased by $6.5 million to $31.0 million for the nine months ended September 30, 2023 from $24.5 million for the nine months ended September 30, 2022 primarily due to:
•an increase of $3.9 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
•an increase of $2.0 million in commercial readiness costs due to increased commercial readiness activities being undertaken,
•an increase of $0.5 million related to information technology infrastructure and support for information systems related to the conduct of corporate and commercial operations,
•an increase of $0.4 million in facility costs due to the increase in space utilized for general and administrative activities and related to general office expenses,
•an increase of $0.2 million in depreciation and amortization related to property, plant and equipment and intangible assets, offset by:
•a decrease of $0.5 million primarily related to a reduction in directors' and officers' liability insurance premiums, legal and professional fees.
Loss on disposal of property and equipment
For the nine months ended September 30, 2023, we recognized a loss on disposal of property and equipment of $3.8 million related to fixed assets no longer being utilized in the manufacturing facility exited in Stevenage, United Kingdom and in a leased property in Stevenage, United Kingdom. There were no such disposals for the nine months ended September 30, 2022.
Impairment of operating lease right-of-use assets and related property and equipment
For the nine months ended September 30, 2023, we recognized an impairment loss on operating lease right-of-use assets and related property and equipment of $0.4 million related to a leased property in Stevenage, United Kingdom. There was no impairment recognized for the nine months ended September 30, 2022.
Other expenses, net
Other expenses, net decreased to $0.3 million for the nine months ended September 30, 2023 from $4.2 million for the nine months ended September 30, 2022. The decrease of $3.9 million is primarily due to lower foreign exchange losses of $4.1 million, offset by a lease termination loss of $0.1 million and an increase of other expenses of $0.1 million for the nine months ended September 30, 2023 as compared to the nine months ended September 30, 2022.
Interest Income
Interest income increased to $10.5 million for the nine months ended September 30, 2023, as compared to $0.3 million for the nine months ended September 30, 2022. The increase in interest income of $10.2 million primarily relates to increase in yield and higher account balances associated with our cash and cash equivalents during the nine months ended September 30, 2023 as compared to the nine months ended September 30, 2022.
Interest Expense
Interest expense increased to $14.9 million for the nine months ended September 30, 2023 as compared to $5.4 million for the nine months ended September 30, 2022. Interest expense increased by $9.5 million primarily due to an increase in the balance of the liability for future royalties and sales milestones, net associated with our strategic collaboration agreement with Blackstone.
Income Tax Benefit
Income tax benefit decreased by $6.9 million to $12.4 million for the nine months ended September 30, 2023 from $19.3 million for the nine months ended September 30, 2022 due to a decrease in qualifying research and development expenditures and the reduction in effective tax rate related to the U.K. research and development tax credit regime under the scheme for SMEs, partially offset by an adjustment arising from the finalization of our prior year tax returns.
Liquidity and Capital Resources
Since our inception, we have not generated any commercial product revenue and have incurred operating losses and negative cash flows from our operations. We expect to incur significant expenses and operating losses for the foreseeable future as we advance our product candidates through preclinical and clinical development and seek regulatory approval and pursue commercialization of any approved product candidates. We expect that our research and development and general and administrative expenses may increase in connection with our planned research, clinical development and potential commercialization activities. As a result, we will need significant additional capital to fund our operations until such time as we can generate significant revenue from product sales.
We do not currently have any approved products and have never generated any commercial revenue from product sales. We have funded our operations to date primarily with proceeds from government grants, sales of our equity securities, through public offerings and sales pursuant to our at-the-market facility, reimbursable U.K. research and development tax credits and receipts from the U.K. RDEC scheme, out-licensing arrangements and strategic collaboration agreements. From our inception in 2014 through September 30, 2023, we have raised $1.1 billion from these capital sources.
As of September 30, 2023, we had cash and cash equivalents of $256.4 million.
Cash Flows
The following table summarizes our cash flows for each of the periods presented (in thousands):
| | | | | | | | | | | |
| Nine Months Ended September 30, |
| 2023 | | 2022 |
Net cash used in operating activities | $ | (120,754) | | | $ | (97,742) | |
Net cash used in investing activities | (9,509) | | | (10,208) | |
Net cash (used in) provided by financing activities | (906) | | | 101 | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 5,257 | | | (39,459) | |
Net decrease in cash, cash equivalents and restricted cash | $ | (125,912) | | | $ | (147,308) | |
Net Cash Used in Operating Activities
During the nine months ended September 30, 2023, operating activities used $120.8 million of cash, resulting from our net loss of $131.2 million, and net cash used resulting from changes in our operating assets and liabilities of $20.5 million, partially offset by non-cash charges of $31.0 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2023 consisted primarily of decreases in accrued expenses and other liabilities of $6.8 million, a $9.0 million decrease in current and non-current operating lease liabilities, net of operating lease right of use assets, and a net increase of $5.7 million in prepaid expenses and other current and non-current assets, offset by an increase in accounts payable of $0.1 million and a decrease in long-term deposits of $0.9 million.
During the nine months ended September 30, 2022, operating activities used $97.7 million of cash, resulting from our net loss of $121.9 million, and net cash used resulting from changes in our operating assets and liabilities of $5.6 million, partially offset by non-cash charges of $29.8 million. Net cash used in operating activities resulting from changes in our operating assets and liabilities for the nine months ended September 30, 2022 consisted primarily of a $20.5 million increase in prepaid expenses and other current and non-current assets and an increase in accrued expenses and other liabilities of $15.5 million. This cash used was offset by a decrease in accounts payable of $0.1 million and a $0.5 million decrease in right of use assets from amortization and operating lease liabilities, net.
Net Cash Used in Investing Activities
During the nine months ended September 30, 2023 and 2022, we used $9.5 million and $10.2 million, respectively, of cash in investing activities, all of which consisted of purchases of property and equipment. Property and equipment purchased during the nine months ended September 30, 2023 related primarily to assets under construction associated with the fit-out of the Nucleus manufacturing facility.
Net Cash (used in) provided by Financing Activities
During the nine months ended September 30, 2023, net cash used in financing activities primarily relates to payments of issuance costs relating to prior financings of $0.9 million. During the nine months ended September 30, 2022 net cash provided by financing activities of $0.1 million primarily relates to proceeds received from the exercise of share options.
Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we continue pre-commercial activities for obe-cel, complete the qualification of our new commercial manufacturing facility and advance the preclinical activities and clinical trials of our product candidates. Our expenses will increase as we:
•seek regulatory approvals for obe-cel or any other product candidates that successfully complete preclinical and clinical trials;
•establish a sales, marketing and distribution infrastructure in anticipation of commercializing of any product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;
•hire additional clinical, medical and development personnel;
•expand our infrastructure and facilities to accommodate our growing employee base; and
•maintain, expand and protect our intellectual property portfolio.
Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, clinical costs, external research and development services, laboratory and related supplies, legal and other regulatory expenses, and administrative and overhead costs. Our future funding requirements will be heavily determined by the resources needed to support the development of our product candidates.
Based on our current clinical development plans, we believe our current cash and cash equivalents will be sufficient to fund our current and planned operating expenses and capital expenditure requirements for at least the next twelve months from the date of the issuance of these unaudited condensed consolidated financial statements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. If we receive regulatory approval for obe-cel or any of our other product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•the scope, progress, outcome and costs of our clinical trials and other research and development activities;
•the costs, timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
•the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
•the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;
•the costs and timing of hiring new employees to support our continued growth;
•the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
•the extent to which we in-license or acquire additional product candidates or technologies.
Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of public or private equity offerings, reimbursable U.K. research and development tax credits and receipts from the U.K. RDEC scheme, out-licensing arrangements, or strategic collaboration agreements. To the extent that we raise additional capital through the sale of equity, the ownership interest of existing shareholders will be diluted. If we raise additional funds through other third-party funding, collaborations agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.
Critical Accounting Policies and Significant Judgments and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States, "U.S. GAAP". The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
We included an update to our significant judgements and accounting estimates from those described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Annual Report.
Lease Term—Impact on Right-of-Use Assets and Lease Liabilities
In September 2021, we entered into an arrangement for lease with the landlord, Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of our new 70,000 square foot commercial manufacturing facility, referred to as, The Nucleus, in Stevenage, United Kingdom. Under this arrangement, the landlord leased the facility to us on agreed terms, upon satisfaction of certain conditions and completion of construction. Beginning in November 2022, the landlord handed over various portions of the facility to us; on July 31, 2023, they confirmed practical completion of The Nucleus. We were required to pay a pro-rated license fee for each portion of the facility which we were granted access until execution of the lease agreement. As the landlord provided us with access to portions of the facility, the definition of a lease in accordance with ASC 842, was met. The lease term can materially impact the value of the right of use assets and lease liabilities recorded on our balance sheet as required under ASC 842.
On September 19, 2023, we entered into a 20-year lease agreement with Forge Life Sciences Nominee for The Nucleus. We calculated the lease term for The Nucleus by taking into account, the noncancellable period specified in the agreement together with the periods a license fee was payable by us to the landlord for portions of The Nucleus handed over to us. The foregoing description of the Nucleus lease is qualified in its entirety by the lease itself, which we will file as an exhibit to our Annual Report for FY2023.
JOBS Act
The Jumpstart Our Business Startups Act, or the JOBS Act, provides that, among other things, an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. As an emerging growth company, we have irrevocably elected not to take advantage of the extended transition period afforded by the JOBS Act for implementation of new or revised accounting standards and, as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth public companies until the date we are no longer an emerging growth company.
We also currently rely on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, we are not required to, among other things, (i) provide an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b), (ii) provide all of the compensation disclosure that may be required of non-emerging growth public companies under the Dodd-Frank Wall Street Reform and Consumer Protection Act, (iii) comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis), or (iv) disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the chief executive officer’s compensation to median employee compensation.
As of December 31, 2023, we will no longer be an emerging growth company. As a result, we will no longer be able to take advantage of reduced disclosure and other obligations that are available to emerging growth companies after that date.
Recent Accounting Pronouncements Not Yet Adopted
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, “Summary of Significant Accounting Policies,” to our unaudited condensed consolidated financial statements included in Exhibit 99.1 of this Report on Form 6-K.
Autolus Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates November 2, 2023 at 7:12 AM EDT Obe-cel, a potentially transformational treatment for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL), on track for a Biologics License Application (BLA) submission to the US Food & Drug Administration (FDA) by end of 2023 Updated clinical data at the American Society of Hematology (ASH) meeting in December 2023: Long-term follow-up and sub-group analysis from the FELIX trial of obe-cel and initial data from a study of AUTO8 in multiple myeloma Continued progress with commercial manufacturing facility, The Nucleus, with process performance qualification production phase complete and data package on track to support BLA submission Obe-cel Phase 1 study in refractory systemic lupus erythematosus (SLE) expected to initiate in early 2024 Conference call to be held today at 09:00 am EDT/1:00 pm GMT: Conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announced its operational and financial results for the quarter ended September 30, 2023. “The coming months will be an exciting and instrumental time for Autolus as we plan for our first BLA submission for obe-cel with the US FDA by year end and we continue with our preparatory activities for a planned commercial launch in 2024, pending the necessary regulatory approvals,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “The data we have observed to date in the FELIX study highlights the potential of obe-cel to deliver a high complete remission rate combined with low levels of immunotoxicity and excellent CAR T expansion and persistence in adult patients with relapsed/refractory ALL. We look forward to building on the positive data when we present longer term follow up and additional subgroup analysis data at ASH in December.” “Alongside this, our commercial manufacturing facility, The Nucleus, completed process performance qualification activities in Q4 to support the BLA submission, and we believe we are in a strong position operationally to deliver product and meet the global demand for adult ALL treatment.” “Obe-cel’s excellent risk/benefit profile combined with its ability to make deep cuts into the CD19+ cell compartment, as illustrated by MRD-negative complete remissions in adult and pediatric ALL patients, is a strong foundation for the development of obe-cel in autoimmune disease. The clinical profile together with our commercial product delivery base, attractive cost of goods, and commercial infrastructure should help to drive an accelerated and differentiated expansion of the obe-cel opportunity. We are excited at the growing body of evidence that CAR T can address a significant unmet need in autoimmune disease, and we look forward to starting a Phase I study of obe-cel in refractory systemic lupus erythematosus (SLE) patients in early 2024.” Key obecabtagene autoleucel (obe-cel) updates and anticipated milestones: Obe-cel in relapsed / refractory (r/r) adult ALL – The FELIX Study Longer term follow-up data and subgroup analysis data will be presented at ASH in December 2023, as well as at medical conferences in H1 2024. BLA submission is on track to the FDA by the end of 2023 and a submission of a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024. Obe-cel in B-cell mediated autoimmune diseases Phase 1 study in refractory SLE patients is on track to start in early 2024, with initial clinical data expected in late 2024. Pipeline clinical trials, in collaboration with University College London (UCL), updates and anticipated milestones AUTO1/22 in pediatric B-ALL patients – Phase 1 CARPALL Study The data presented at European Society for Blood and Marrow Transplantation (EBMT) in April 2023 on the AUTO1/22 Phase 1 CARPALL study was published in Blood, in August 2023, entitled ‘CD19/CD22 targeting with co-transduced CAR T-cells to prevent antigen negative relapse after CAR T-cell therapy of B-ALL’. AUTO8 in Multiple Myeloma – Phase 1 MCARTY Study
AUTO8 is a next-generation product candidate for multiple myeloma, which comprises two CARs for the multiple myeloma targets, BCMA and CD19. In collaboration with UCL, the Company initiated a study in 2022. Patients continue to be enrolled and initial data will be presented at ASH in December 2023. AUTO6NG in Neuroblastoma – Phase 1 MAGNETO Study AUTO6NG contains a CAR that targets GD2 alongside additional programming modules to enhance the activity and persistence. UCL has received MHRA approval for the conduct of a Phase 1 clinical study in children with r/r neuroblastoma. The study is on track to be initiated in Q4 2023. Key Operational Updates during Q3 2023 The Company’s new 70,000 square foot commercial manufacturing facility, The Nucleus, in Stevenage, UK has completed process performance qualification and is on track to support the BLA submission for obe-cel. The Company estimates capacity of approximately 2,000 batches per annum, which is anticipated to be sufficient to meet US and EU adult ALL demand. Previously announced leadership appointments of Rob Dolski as Chief Financial Officer, effective August 7, 2023, as well as Dr. Veronica Hersberger as Senior Vice President, Medical Affairs and Miranda Neville as Senior Vice President Program Management. Scientific Publications: Publication of a paper in Nature Medicine titled: ‘ Transcriptional hallmarks of persisting CD19 CAR T-cells in children with leukemia’ - Ghorashian, S. et al, Nature Medicine; 2023. doi: 10.1038/s41591-023-02415-3. Link to paper. Publication of a paper in Blood titled: ‘ CD19/CD22 targeting with co-transduced CAR T-cells to prevent antigen negative relapse after CAR T-cell therapy of B-ALL’ - Ghorashian et al, Blood; doi.org/10.1182/blood.2023020621. Link to paper. Expected News Flow Obe-cel BLA submission to FDA By end 2023 Obe-cel FELIX data at ASH December 2023 AUTO8 update (MCARTY) at ASH December 2023 AUTO6NG Phase 1 study start (MAGNETO) By end 2023 Obe-cel in autoimmune disease – refractory SLE Phase 1 study start Early 2024 Obe-cel filing for a Marketing Authorization Application to EMA First half 2024 Financial Results for the Third Quarter Ended September 30, 2023 Cash and cash equivalents at September 30, 2023, totaled $256.4 million, as compared to $382.4 million at December 31, 2022. Total operating expenses, net for the three months ended September 30, 2023, were $47.8 million, as compared to $43.5 million, for the same period in 2022. Research and development expenses decreased by $0.4 million to $37.2 million for the three months ended September 30, 2023 compared to the same period in 2022. This change was primarily due to decreases in clinical and manufacturing costs related to the Company’s obe-cel clinical program partially offset by increases in operating costs related to the Company’s new commercial manufacturing facility and in salaries and related costs driven by increased headcount. General and administrative expenses increased by $2.4 million to $10.6 million for the three months ended September 30, 2023 compared to the same period in 2022. This increase was primarily due to salaries and other employment-related costs driven by an increase in general and administrative headcount supporting the overall growth of the business, primarily relating to pre-commercialization activities. Net loss attributable to ordinary shareholders was $45.8 million for the three months ended September 30, 2023, compared to $42.8 million for the same period in 2022. The basic and diluted net loss per ordinary share for the three months ended September 30, 2023, totaled $(0.26) compared to a basic and diluted net loss per ordinary share of $(0.47) for the three months ended September 30, 2022. Autolus estimates that its current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the Company’s cash runway into 2025. Unaudited Financial Results for the Third Quarter Ended September 30, 2023 Selected Condensed Consolidated Balance Sheet Data (In thousands) September 30, December 31, 2023 2022 Assets
Cash and cash equivalents $ 256,415 $ 382,436 Total current assets $ 308,382 $ 425,771 Total assets $ 406,098 $ 490,274 Liabilities and shareholders' equity Total current liabilities $ 37,540 $ 46,366 Total liabilities $ 225,580 $ 191,600 Total shareholders' equity $ 180,518 $ 298,674 Total liabilities and shareholders' equity $ 406,098 $ 490,274 Selected Condensed Consolidated Statements of Operations and Comprehensive Loss Data (In thousands, except share and per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Grant income — — — $ 166 License revenues $ 406 $ 2,369 $ 1,698 $ 2,369 Operating expenses: Research and development (37,237) (37,632) (105,323) (109,806) General and administrative (10,611) (8,231) (31,017) (24,487) Loss on disposal of property and equipment — — (3,791) — Impairment of operating lease right-of-use assets and related property and equipment (382) — (382) — Total operating expenses, net (47,824) (43,494) (138,815) (131,758) Total other expense, net (2,965) (5,425) (4,777) (9,380) Net loss before income tax (50,789) (48,919) (143,592) (141,138) Income tax benefit 4,940 6,152 12,380 19,250 Net loss attributable to ordinary shareholders (45,849) (42,767) (131,212) (121,888) Other comprehensive (loss) income Foreign currency exchange translation adjustment (5,837) (14,054) 5,104 (38,994) Total comprehensive loss $ (51,686) $ (56,821) $ (126,108) $ (160,882) Basic and diluted net loss per ordinary share $ (0.26) $ (0.47) $ (0.75) $ (1.34) Weighted-average basic and diluted ordinary shares 173,984,101 91,240,801 173,890,666 91,028,562 Conference Call Management will host a conference call and webcast at 9:00 am EDT/1:00 pm GMT to discuss the company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website. About Autolus Therapeutics plc Autolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a 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 target cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com. About obe-cel (AUTO1) Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Obe-cel is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. Clinical trials of obe-cel have demonstrated that this “fast off-rate” profile reduces toxicity and T cell exhaustion, resulting in improved persistence and leading to high levels of durable remissions in r/r Adult ALL patients. The results of the FELIX trial, a pivotal trial for adult ALL, are being prepared for regulatory submissions with the FDA and EMA. In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL. About obe-cel FELIX clinical trial Autolus’ Phase Ib/II clinical trial of obe-cel enrolled adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase Ib component prior to proceeding to the single arm, Phase II clinical trial. The primary endpoint is overall response rate, and the secondary endpoints include duration of response, MRD negative CR rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660] About AUTO1/22 AUTO1/22 is a novel dual targeting CAR T cell-based therapy candidate based on obe-cel. It is designed to combine the enhanced safety, robust
expansion and persistence seen with the fast off rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to reduce antigen negative relapses. This product candidate is currently in a Phase I clinical trial for patients with r/r pediatric ALL. [NCT02443831] About AUTO6NG AUTO6NG is a next generation programmed T cell product candidate in pre-clinical development. AUTO6NG builds on preliminary proof of concept data from AUTO6, a CAR targeting GD2-expression cancer cell currently in clinical development for the treatment of neuroblastoma. AUTO6NG incorporates additional cell programming modules to overcome immune suppressive defense mechanisms in the tumor microenvironment, in addition to endowing the CAR T cells with extended persistence capacity. AUTO6NG is currently in pre-clinical development for the potential treatment of both neuroblastoma and other GD2-expressing solid tumors. About AUTO8 AUTO8 is a next-generation product candidate for multiple myeloma which comprises two independent CARs for the multiple myeloma targets, BCMA and CD19. We have developed an optimized BCMA CAR which is designed for improved killing of target cell that express BCMA at low levels. This has been combined with fast off rate CD19 CAR from obe-cel. We believe that the design of AUTO8 has the potential to induce deep and durable responses and extend the durability of effect over other BCMA CARs currently in development. This product candidate is currently in a Phase I clinical trial for patients with r/r multiple myeloma. [NCT04795882] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the development of obe-cel and Autolus’ other product candidates, including statements regarding the initiation, timing, progress and the results of clinical studies or trials and related preparatory work, the period during which the results of the trials will become available and research and development activities; the timing of availability or disclosure of data from those clinical trials and the timing of planned regulatory submissions; the potential for obe-cel or Autolus’ other product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, obe-cel or Autolus’ other product candidates will be successfully distributed, marketed and commercialized; the size and growth potential of the markets for obe-cel or Autolus’ other product candidates, if approved, and the rate and degree of market acceptance of obe-cel or Autolus’ other product candidates, including reimbursement that may be received from payors; potential therapeutic effects of obe-cel and Autolus’ other product candidates; anticipated clinical data presentations; Autolus’ commercialization, marketing and manufacturing capabilities and strategy; the commercial potential of obe-cel; the progress and estimated completion of the Company’s commercial manufacturing facility including anticipated capacity; the Company’s ability to achieve milestones and receive associated milestone payments pursuant to the terms of its collaboration agreements, including pursuant to the Blackstone collaboration and the Company’s expected cash runway. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing, and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; any of Autolus’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Autolus may not achieve milestones or receive additional payments under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions; and the impact of the global health crises or geopolitical conditions on Autolus’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Autolus’ behalf; Autolus’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; and inability to maintain or enter into new partnerships or strategic collaborations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 7, 2023, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. Contact: Julia Wilson +44 (0) 7818 430877 j.wilson@autolus.com Susan A. Noonan S.A. Noonan Communications +1-917-513-5303 susan@sanoonan.com Lauren Williams Investase +44 23 9438 7760 lauren@investase.com
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v3.23.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 256,415
|
$ 382,436
|
Restricted cash |
434
|
325
|
Prepaid expenses and other current assets |
51,533
|
43,010
|
Total current assets |
308,382
|
425,771
|
Non-current assets: |
|
|
Property and equipment, net |
34,637
|
35,209
|
Prepaid expenses and other non-current assets |
136
|
2,176
|
Operating lease right-of-use assets, net |
59,403
|
23,210
|
Long-term deposits |
943
|
1,832
|
Deferred tax asset |
2,597
|
2,076
|
Total assets |
406,098
|
490,274
|
Current liabilities: |
|
|
Accounts payable |
661
|
531
|
Accrued expenses and other liabilities |
31,388
|
40,797
|
Operating lease liabilities, current |
5,491
|
5,038
|
Total current liabilities |
37,540
|
46,366
|
Non-current liabilities: |
|
|
Operating lease liabilities, non-current |
46,967
|
19,218
|
Liability related to future royalties and sales milestones, net |
140,778
|
125,900
|
Other long-term payables |
295
|
116
|
Total liabilities |
225,580
|
191,600
|
Commitments and contingencies |
|
|
Shareholders' equity: |
|
|
Additional paid-in capital |
1,015,577
|
1,007,625
|
Accumulated other comprehensive loss |
(33,794)
|
(38,898)
|
Accumulated deficit |
(801,391)
|
(670,179)
|
Total shareholders' equity |
180,518
|
298,674
|
Total liabilities and shareholders' equity |
406,098
|
490,274
|
Ordinary shares |
|
|
Shareholders' equity: |
|
|
Share value |
8
|
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
|
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v3.23.3
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals)
|
Sep. 30, 2023
$ / shares
shares
|
Sep. 30, 2023
£ / shares
shares
|
Dec. 31, 2022
$ / shares
shares
|
Dec. 31, 2022
£ / 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) |
173,936,794
|
173,936,794
|
173,074,510
|
173,074,510
|
Shares outstanding (in shares) |
173,936,794
|
173,936,794
|
173,074,510
|
173,074,510
|
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
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Operating expenses: |
|
|
|
|
Research and development |
$ (37,237)
|
$ (37,632)
|
$ (105,323)
|
$ (109,806)
|
General and administrative |
(10,611)
|
(8,231)
|
(31,017)
|
(24,487)
|
Loss on disposal of property and equipment |
0
|
0
|
(3,791)
|
0
|
Impairment of operating lease right-of-use assets and related property and equipment |
(382)
|
0
|
(382)
|
0
|
Total operating expenses, net |
(47,824)
|
(43,494)
|
(138,815)
|
(131,758)
|
Other income (expense): |
|
|
|
|
Other expenses, net |
(1,597)
|
(3,740)
|
(333)
|
(4,214)
|
Interest income |
3,646
|
165
|
10,495
|
282
|
Interest expense |
(5,014)
|
(1,850)
|
(14,939)
|
(5,448)
|
Total other expense, net |
(2,965)
|
(5,425)
|
(4,777)
|
(9,380)
|
Net loss before income tax |
(50,789)
|
(48,919)
|
(143,592)
|
(141,138)
|
Income tax benefit |
4,940
|
6,152
|
12,380
|
19,250
|
Net loss attributable to ordinary shareholders |
(45,849)
|
(42,767)
|
(131,212)
|
(121,888)
|
Other comprehensive (loss) income: |
|
|
|
|
Foreign currency exchange translation adjustment |
(5,837)
|
(14,054)
|
5,104
|
(38,994)
|
Total comprehensive loss |
$ (51,686)
|
$ (56,821)
|
$ (126,108)
|
$ (160,882)
|
Basic net loss per ordinary share (in usd per share) |
$ (0.26)
|
$ (0.47)
|
$ (0.75)
|
$ (1.34)
|
Diluted net loss per ordinary share (in usd per share) |
$ (0.26)
|
$ (0.47)
|
$ (0.75)
|
$ (1.34)
|
Weighted-average basic ordinary shares (in shares) |
173,984,101
|
91,240,801
|
173,890,666
|
91,028,562
|
Weighted-average diluted ordinary shares (in shares) |
173,984,101
|
91,240,801
|
173,890,666
|
91,028,562
|
Grant income |
|
|
|
|
Revenues |
$ 0
|
$ 0
|
$ 0
|
$ 166
|
License revenue |
|
|
|
|
Revenues |
$ 406
|
$ 2,369
|
$ 1,698
|
$ 2,369
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.3
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited) - USD ($) $ in Thousands |
Total |
Ordinary Shares |
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, 2021 |
|
|
|
|
|
90,907,830
|
34,425
|
88,893,548
|
1
|
|
|
|
Beginning balance at Dec. 31, 2021 |
$ 313,320
|
|
|
|
|
$ 4
|
$ 0
|
$ 118
|
$ 0
|
$ 843,108
|
$ (8,570)
|
$ (521,340)
|
Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
8,599
|
|
|
|
|
|
|
|
|
8,599
|
|
|
Vesting of restricted stock (in shares) |
|
|
|
|
|
76,804
|
|
|
|
|
|
|
Vesting of restricted stock |
0
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of share options (in shares) |
|
|
|
|
|
147,722
|
|
|
|
|
|
|
Exercise of share options |
117
|
|
|
|
|
|
|
|
|
117
|
|
|
Unrealized loss on foreign currency translation |
(38,994)
|
|
|
|
|
|
|
|
|
|
(38,994)
|
|
Net loss |
(121,888)
|
|
|
|
|
|
|
|
|
|
|
(121,888)
|
Ending balance (in shares) at Sep. 30, 2022 |
|
|
|
|
|
91,132,356
|
34,425
|
88,893,548
|
1
|
|
|
|
Ending balance at Sep. 30, 2022 |
161,154
|
|
|
|
|
$ 4
|
$ 0
|
$ 118
|
$ 0
|
851,824
|
(47,564)
|
(643,228)
|
Beginning balance (in shares) at Jun. 30, 2022 |
|
|
|
|
|
90,909,783
|
34,425
|
88,893,548
|
1
|
|
|
|
Beginning balance at Jun. 30, 2022 |
214,521
|
|
|
|
|
$ 4
|
$ 0
|
$ 118
|
$ 0
|
848,370
|
(33,510)
|
(600,461)
|
Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
3,337
|
|
|
|
|
|
|
|
|
3,337
|
|
|
Vesting of restricted stock (in shares) |
|
|
|
|
|
76,804
|
|
|
|
|
|
|
Vesting of restricted stock |
0
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of share options (in shares) |
|
|
|
|
|
145,769
|
|
|
|
|
|
|
Exercise of share options |
117
|
|
|
|
|
|
|
|
|
117
|
|
|
Unrealized loss on foreign currency translation |
(14,054)
|
|
|
|
|
|
|
|
|
|
(14,054)
|
|
Net loss |
(42,767)
|
|
|
|
|
|
|
|
|
|
|
(42,767)
|
Ending balance (in shares) at Sep. 30, 2022 |
|
|
|
|
|
91,132,356
|
34,425
|
88,893,548
|
1
|
|
|
|
Ending balance at Sep. 30, 2022 |
161,154
|
|
|
|
|
$ 4
|
$ 0
|
$ 118
|
$ 0
|
851,824
|
(47,564)
|
(643,228)
|
Beginning balance (in shares) at Dec. 31, 2022 |
|
173,074,510
|
34,425
|
88,893,548
|
1
|
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 |
7,948
|
|
|
|
|
|
|
|
|
7,948
|
|
|
Vesting of restricted stock (in shares) |
|
|
|
|
|
860,213
|
|
|
|
|
|
|
Vesting of restricted stock |
0
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of share options (in shares) |
|
|
|
|
|
2,071
|
|
|
|
|
|
|
Exercise of share options |
4
|
|
|
|
|
|
|
|
|
4
|
|
|
Unrealized loss on foreign currency translation |
5,104
|
|
|
|
|
|
|
|
|
|
5,104
|
|
Net loss |
(131,212)
|
|
|
|
|
|
|
|
|
|
|
(131,212)
|
Ending balance (in shares) at Sep. 30, 2023 |
|
173,936,794
|
34,425
|
88,893,548
|
1
|
173,936,794
|
34,425
|
88,893,548
|
1
|
|
|
|
Ending balance at Sep. 30, 2023 |
180,518
|
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
1,015,577
|
(33,794)
|
(801,391)
|
Beginning balance (in shares) at Jun. 30, 2023 |
|
|
|
|
|
173,680,872
|
34,425
|
88,893,548
|
1
|
|
|
|
Beginning balance at Jun. 30, 2023 |
229,336
|
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
1,012,709
|
(27,957)
|
(755,542)
|
Stockholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
2,864
|
|
|
|
|
|
|
|
|
2,864
|
|
|
Vesting of restricted stock (in shares) |
|
|
|
|
|
253,851
|
|
|
|
|
|
|
Vesting of restricted stock |
0
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of share options (in shares) |
|
|
|
|
|
2,071
|
|
|
|
|
|
|
Exercise of share options |
4
|
|
|
|
|
|
|
|
|
4
|
|
|
Unrealized loss on foreign currency translation |
(5,837)
|
|
|
|
|
|
|
|
|
|
(5,837)
|
|
Net loss |
(45,849)
|
|
|
|
|
|
|
|
|
|
|
(45,849)
|
Ending balance (in shares) at Sep. 30, 2023 |
|
173,936,794
|
34,425
|
88,893,548
|
1
|
173,936,794
|
34,425
|
88,893,548
|
1
|
|
|
|
Ending balance at Sep. 30, 2023 |
$ 180,518
|
|
|
|
|
$ 8
|
$ 0
|
$ 118
|
$ 0
|
$ 1,015,577
|
$ (33,794)
|
$ (801,391)
|
X |
- DefinitionStock Vested During Period, Shares, Restricted Stock
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v3.23.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Cash flows from operating activities: |
|
|
|
|
|
Net loss |
$ (45,849)
|
$ (42,767)
|
$ (131,212)
|
$ (121,888)
|
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
Depreciation and amortization |
|
|
4,790
|
5,773
|
|
Share-based compensation net of amounts capitalized |
|
|
7,929
|
8,599
|
|
Interest expense accrued on liability related to future royalties and sales milestones, net |
5,000
|
1,800
|
14,878
|
5,427
|
|
Foreign exchange differences |
|
|
(366)
|
10,537
|
|
Loss on termination of operating lease |
|
|
95
|
0
|
|
Loss on disposal of property and equipment |
|
|
3,812
|
0
|
|
Impairment of operating lease right-of-use assets and related property and equipment |
382
|
0
|
382
|
0
|
|
Deferred income tax |
|
|
(520)
|
(587)
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
(7,655)
|
(20,809)
|
|
Non-current prepaid expenses and other non-current assets |
|
|
1,932
|
301
|
|
Long-term deposits |
|
|
937
|
(5)
|
|
Accounts payable |
|
|
69
|
(87)
|
|
Accrued expenses and other liabilities |
|
|
(6,823)
|
15,469
|
|
Current and non-current operating lease liabilities, net of operating lease right of use assets |
|
|
(9,002)
|
(472)
|
|
Net cash used in operating activities |
|
|
(120,754)
|
(97,742)
|
|
Cash flows from investing activities: |
|
|
|
|
|
Purchases of property and equipment |
|
|
(9,509)
|
(10,208)
|
|
Net cash used in investing activities |
|
|
(9,509)
|
(10,208)
|
|
Cash flows from financing activities: |
|
|
|
|
|
Proceeds from the exercise of share options |
|
|
4
|
117
|
|
Payments of equity issuance costs |
|
|
(910)
|
(16)
|
|
Net cash (used in) provided by financing activities |
|
|
(906)
|
101
|
|
Effect of exchange rate changes on cash, cash equivalents and restricted cash |
|
|
5,257
|
(39,459)
|
|
Net decrease in cash, cash equivalents and restricted cash |
|
|
(125,912)
|
(147,308)
|
|
Cash, cash equivalents and restricted cash, beginning of period |
|
|
382,761
|
310,676
|
$ 310,676
|
Cash, cash equivalents and restricted cash, end of period |
256,849
|
163,368
|
256,849
|
163,368
|
382,761
|
Supplemental non-cash flow information |
|
|
|
|
|
Property and equipment purchases included in accounts payable and accrued expenses |
|
|
1,389
|
1,219
|
|
Right-of-use assets obtained in exchange for operating lease liabilities |
|
|
41,211
|
57
|
|
Right of use assets terminated and obtained in exchange for operating lease liabilities, net |
|
|
(1,110)
|
0
|
|
Capitalized implementation costs included in accrued expenses |
|
|
74
|
31
|
|
Capitalized share-based compensation |
|
|
19
|
0
|
|
Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets: |
|
|
|
|
|
Cash and cash equivalents |
256,415
|
163,053
|
256,415
|
163,053
|
382,436
|
Restricted cash |
434
|
315
|
434
|
315
|
325
|
Total cash, cash equivalents and restricted cash |
$ 256,849
|
$ 163,368
|
$ 256,849
|
$ 163,368
|
$ 382,761
|
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v3.23.3
Nature of the Business
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Nature of the Business |
Nature of the Business Autolus Therapeutics plc (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 cancer patients substantial benefits over the existing standard of care, including the potential for cure in some patients. The Company is subject to risks and uncertainties common to early-stage 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. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from its product sales. The Company has funded its operations primarily with proceeds from the sale of equity securities through public offerings and sales pursuant to the Company's at-the-market facility, government grants, U.K. research and development tax credits and receipts from the U.K.'s Research and Development Expenditure Credit program ("RDEC"), out-licensing arrangements and strategic collaboration agreements.
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v3.23.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements include those of the Company and its wholly owned subsidiaries, Autolus Holdings (UK) Limited, Autolus Limited, Autolus Inc. and Autolus GmbH, and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated upon consolidation. The significant accounting policies used in 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 20-F for the year ended December 31, 2022 as filed with the Securities and Exchange Commission on March 7, 2023 (the “Annual Report”). In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, 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, 2022, included in the Annual Report. The Company has incurred recurring losses since its inception, including net losses of $45.8 million and $42.8 million for the three months ended September 30, 2023 and 2022, respectively and $131.2 million and $121.9 million for the nine months ended September 30, 2023 and 2022, respectively. The Company had an accumulated deficit of $801.4 million and $670.2 million as of September 30, 2023 and December 31, 2022, 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 September 30, 2023 of $256.4 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 the going concern basis. Foreign Currency Translation The reporting currency of the Company is the U.S. dollar. The Company has determined the functional currency of the ultimate parent company, Autolus Therapeutics plc, is Pound Sterling. The functional currency of subsidiary operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the 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 losses of $1.7 million and $3.8 million for the three months ended September 30, 2023 and 2022, respectively, and foreign exchange losses of $0.4 million and $4.4 million for the nine months ended September 30, 2023 and 2022, respectively, which are included in other (expenses) income, net in the unaudited condensed consolidated statements of operations and comprehensive loss. Use of Estimates Lease Term—Impact on Right-of-Use Assets and Lease Liabilities In September 2021, the Company entered into an arrangement for lease with Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of the Company's new 70,000 square foot commercial manufacturing facility, referred to as, The Nucleus, in Stevenage, United Kingdom. Under this arrangement, the landlord leased the facility to the Company on agreed terms, upon satisfaction of certain conditions and completion of construction. Since November 2022, the landlord has handed over various portions of the facility to the Company until July 31, 2023 when the landlord and the Company accepted practical completion of The Nucleus. The Company was required to pay a pro-rated license fee for each portion of the facility which the Company has been granted access until execution of the lease agreement. As the landlord provided the Company with access to portions of the facility, the definition of a lease in accordance with ASC 842, was met. The lease term can materially impact the value of the right of use assets and lease liabilities recorded on our balance sheet as required under ASC 842. On September 19, 2023, the Company entered into a 20 year lease agreement with Forge Life Sciences Nominee for The Nucleus. The Company calculated the lease term for The Nucleus by taking into account, the noncancellable period specified in the agreement together with the periods a license fee was payable by the Company to the landlord for portions of The Nucleus handed over to the Company. Recent Accounting Pronouncements Not Yet Adopted There are no new accounting pronouncements that have been issued by the Financial Accounting Standards Board, “FASB”, that are applicable to the Company.
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v3.23.3
License Revenue
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
License Revenue |
License Revenue Revenue comprised of license revenue for the three and nine months ended September 30, 2023, and 2022 and is represented in the table below by geographical location (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | License revenue | | | | | | | | | United Kingdom | | $ | 346 | | | $ | 60 | | | $ | 346 | | | $ | 60 | | United States | | $ | 60 | | | $ | 2,309 | | | $ | 1,352 | | | $ | 2,309 | | Total license revenue | | $ | 406 | | | $ | 2,369 | | | $ | 1,698 | | | $ | 2,369 | |
Research, 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, “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 hereunder 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. No license revenue was recognized related to the Cabaletta Agreement for the three months ended September 30, 2023. The Company recognized total license revenue of $1.2 million, related to the Cabaletta Agreement for the nine months ended September 30, 2023. 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 September 30, 2023. Research, Option and License Agreement with an Investee of Syncona Portfolio Limited The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the three and nine months ended September 30, 2023, Company received variable consideration arising from the achievement of a development milestone amounting to $0.35 million. Consequently, the Company recognized license revenue of $0.35 million (net of foreign exchange differences). Research, Option and License Agreement with Moderna: On June 22, 2021, the Company entered into a Research, Option and License Agreement (the “Moderna Agreement”) with ModernaTX, Inc. (“Moderna”), pursuant to which the Company granted to Moderna an exclusive research license to perform research and pre-clinical development activities relating to target sequences with respect to certain of the Company’s research targets and products. During the three and nine months ended September 30, 2022, Moderna exercised its option, pursuant to the terms of the Moderna Agreement, to license the Company’s proprietary binders against an undisclosed immuno-oncology target for the development and commercialization of mRNA therapeutics resulting in the Company recognizing $2.2 million (net of foreign exchange differences). 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 September 30, 2023. For further details on the terms and accounting treatment considerations for the Moderna Agreement, please refer to Note 3, "Revenue" to the Company's consolidated financial statements contained in Company's Annual Report filed on March 7, 2023.
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v3.23.3
Prepaid Expenses and Other Current Assets
|
9 Months Ended |
Sep. 30, 2023 |
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): | | | | | | | | | | | | | September 30, | | December 31, | | 2023 | | 2022 | Research and development claims receivable | $ | 37,111 | | | $ | 24,685 | | Prepayments | 7,535 | | | 12,337 | | VAT receivable | 2,327 | | | 2,701 | | Other receivable | 2,357 | | | 1,469 | | Deferred cost | 1,911 | | | 1,494 | | Other assets | 127 | | | 203 | | Accounts receivable | 165 | | | 121 | | Total prepaid expenses and other current assets | $ | 51,533 | | | $ | 43,010 | |
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v3.23.3
Property and Equipment, Net
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, Net |
Property and Equipment, Net Property and equipment, net consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2023 | | 2022 | Lab equipment | $ | 26,362 | | | $ | 31,188 | | Office equipment | 4,416 | | | 3,573 | | Furniture and fixtures | 1,982 | | | 1,221 | | Leasehold improvements | 12,655 | | | 13,583 | | Assets under construction | 18,239 | | | 13,186 | | Less: accumulated depreciation | (29,017) | | | (27,542) | | Total property and equipment, net | $ | 34,637 | | | $ | 35,209 | |
Depreciation expense for the three months ended September 30, 2023 and 2022 was $1.4 million and $1.8 million, respectively, and for the nine months ended September 30, 2023 and 2022 was $4.8 million and $5.7 million, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.3
Accrued Expenses and Other Liabilities
|
9 Months Ended |
Sep. 30, 2023 |
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): | | | | | | | | | | | | | September 30, | | December 31, | | 2023 | | 2022 | Research and development costs | $ | 17,863 | | | $ | 26,478 | | Compensation and benefits | 10,169 | | | 10,181 | | Professional fees | 2,873 | | | 3,745 | | | | | | Other liabilities | 483 | | | 393 | | Total accrued expenses and other liabilities | $ | 31,388 | | | $ | 40,797 | |
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- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.3
Shareholders’ Equity
|
9 Months Ended |
Sep. 30, 2023 |
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 September 30, 2023, the Company has not declared any dividends. December 2022 Public Offering In December 2022, the Company completed an underwritten public offering of 81,927,012 ADSs representing 81,927,012 ordinary shares, which includes the partial exercise by the underwriters of an option to purchase an additional 6,927,012 ADSs, at a public offering price of $2.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $152.4 million. Restricted stock units At September 30, 2023, 56,269 ordinary shares underlying restricted stock unit awards have vested, however, these restricted stock unit awards have not been issued and, as such are not included in the calculation of the Company's outstanding shares at September 30, 2023. Subsequent to September 30, 2023, 52,363 ordinary shares underlying restricted stock unit awards have been issued.
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- DefinitionThe entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.
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v3.23.3
Share-based Compensation Expense
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Share-based Compensation Expense |
Share-based Compensation Expense Share-based compensation expense recorded as research and development expenses, general and administrative expenses and capitalized is as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Research and development | $ | 1,525 | | | $ | 1,831 | | | $ | 4,982 | | | $ | 4,802 | | General and administrative | 1,335 | | | 1,506 | | | 2,947 | | | 3,797 | | Capitalized | 4 | | | — | | | 19 | | | — | | Total share-based compensation | $ | 2,864 | | | $ | 3,337 | | | $ | 7,948 | | | $ | 8,599 | |
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- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Net loss per share
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Net loss per share |
Net loss per share Basic and diluted net loss per share attributable to ordinary shareholders was calculated as follows (in thousands, except share and per share amounts): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Numerator | | | | | | | | Net loss | $ | (45,849) | | | $ | (42,767) | | | $ | (131,212) | | | $ | (121,888) | | Net loss attributable to ordinary shareholders - basic and diluted | $ | (45,849) | | | $ | (42,767) | | | $ | (131,212) | | | $ | (121,888) | | | | | | | | | | Denominator | | | | | | | | Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 173,984,101 | | | 91,240,801 | | | 173,890,666 | | | 91,028,562 | | Basic and diluted net loss per ordinary share | $ | (0.26) | | | $ | (0.47) | | | $ | (0.75) | | | $ | (1.34) | |
For all periods presented, outstanding but unvested restricted shares 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 and Nine Months Ended September 30, | | 2023 | | 2022 | Unvested restricted shares and units | 264,326 | | | 996,927 | | Share options | 14,074,842 | | | 10,421,137 | | Warrants | 3,265,306 | | | 3,265,306 | | Total potentially dilutive securities | 17,604,474 | | | 14,683,370 | |
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v3.23.3
Liability related to sales of future royalties and sales milestones, net
|
9 Months Ended |
Sep. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Liability related to sales of future royalties and sales milestones, net |
Liability related to future royalties and sales milestones, net 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 8, “Liability related to future royalties and sales milestones, net” •Note 9, "Warrants" •Note 10, "Shareholders' equity" 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 relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (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 September 30, 2023 and December 31, 2022, respectively. On a quarterly basis, the Company assesses the amount and timing of expected royalty and sales milestone payments 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 Blackstone Collaboration Agreement liability using the catch-up method. During the three and nine months ended September 30, 2023, there have been no changes to the estimates used in the determination of the carrying amount of the Blackstone Collaboration Agreement liability. There are a number of factors that could materially affect the probability, amount and timing of royalty and sales milestone payments to be made by the Company and Blackstone Development payment to be received from Blackstone, respectively, most of which are not within the Company’s control. The Blackstone Collaboration Agreement liability is recognized using significant unobservable inputs. These inputs are derived using internal management estimates developed based on third party data and reflect management’s judgements, current market conditions surrounding competing products, and forecasts. The significant unobservable inputs include regulatory approvals, estimated patient populations, 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. Changes to the Blackstone Collaboration Agreement liability related to future royalties and sales milestones are as follows: | | | | | | | | | | | | | | | Amount in thousands | | | | | | | | | | | Balance at December 31, 2021 | | | $ | 47,016 | | Proceeds from Blackstone Development Payments received | | 70,000 | | Interest expense accrued on liability related to future royalties and sales milestones, net | | 8,005 | | Cumulative catch-up adjustment | | 879 | | Balance at December 31, 2022 | | | $ | 125,900 | | Interest expense accrued on liability related to future royalties and sales milestones, net | | 14,878 | | Balance at September 30, 2023 | | | $ | 140,778 | |
During the three months ended September 30, 2023 and 2022 interest expense accrued on liability related to future royalties and sales milestones, net amounted to $5.0 million and $1.8 million, respectively. During the nine months ended September 30, 2023 and 2022 interest expense accrued on liability related to future royalties and sales milestones, net amounted to $14.9 million and $5.4 million, respectively.
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v3.23.3
Leases
|
9 Months Ended |
Sep. 30, 2023 |
Leases [Abstract] |
|
Leases |
Leases 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. Operating Leases In September 2017, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through May 2021, at which time the Company had the option to renew or terminate the lease. The lease had a six-month rent-free period. In December 2018, the Company executed an additional lease arrangement for additional manufacturing space for a term through September 2023, at which time the Company has the option to renew or terminate the lease. In addition, in May 2020, the Company executed an arrangement with Cell Therapy Catapult Limited to lease a manufacturing suite at the Cell and Gene Therapy Catapult manufacturing center in Stevenage, United Kingdom for a term through April 2024. In July 2022, the Company and Cell Therapy Catapult Limited mutually agreed: (i) to extend the lease term of a manufacturing suite leased by the Company from April 2024 to February 2025, and (ii) to reduce the lease term of a different manufacturing suite leased by the Company from July 2024 to June 2023. In March 2023, the Company and Cell Therapy Catapult Limited mutually agreed: (i) to terminate the lease relating to the leased manufacturing suite which originally had a lease term until February 2025, (ii) to extend the lease term of one of the remaining manufacturing suites from June 2023 to August 2024, and (iii) to extend the lease term of a third manufacturing suite leased by the Company from September 2023 to August 2024. The Company recognized a lease termination loss of $0.1 million for the nine months ended September 30, 2023 related to the manufacturing suite terminated and exited on March 31, 2023. In addition, during the nine months ended September 30, 2023, the Company recognized a loss on disposal on leasehold improvements of $3.8 million arising from the manufacturing suite terminated and exited on March 31, 2023. In October 2018, the Company executed an agreement to sublease office space in Rockville, Maryland for a term through October 2021. The Company then terminated the sublease in February 2020 and immediately entered into a five-year lease for the same space with the landlord. The lease related to this facility is classified as an operating lease. In January 2019, the Company executed a lease agreement with Whitewood Media Village GP Limited and Whitewood Media Village Nominee Limited to lease the fifth floor of MediaWorks including laboratory space. In August 2021, MediaWorks became the Company's main corporate headquarters. The lease term is nine years and eleven months with an eighteen-month rent free period at the beginning of the lease term. The Company has the option to terminate the lease in November 2026. In February 2019, the Company entered into a fifteen-year lease for three manufacturing units in Enfield, United Kingdom with option to terminate the lease in February 2029. In addition to base rent, the Company is obligated to pay its proportionate share of building operating expenses and real estate taxes in excess of base year amounts. In March 2021, one of the units was split into two separate units and the Company surrendered one of the units. Upon the surrender, the Company recognized a $0.1 million gain in other (expense) income after recognizing a termination fee of $0.2 million. The Company has no further obligations for the surrendered unit and the right of use asset and lease liability which were recorded for this unit have been written off in the relevant period. The Company subleased two of the three units to third parties with lease terms ranging from October, 2021 to February 2029 and October 2026, respectively. The Company is actively seeking to sublease or assign the lease arrangements relating to the final unit. The Company completed an asset impairment analysis of the right-of-use lease concluding the undiscounted cash flows exceeded the carrying value as of September 30, 2023. In September 2021, the Company entered into an arrangement for lease with the landlord, Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of a new 70,000 square foot commercial manufacturing facility in Stevenage, United Kingdom. Under this arrangement, the landlord leased the facility, which will be called The Nucleus, to the Company on agreed terms, upon satisfaction of certain conditions and completion of construction. Since November 2022, the landlord has handed over various portions of the facility to the Company until July 31, 2023 when the landlord and the Company accepted practical completion of The Nucleus. The Company is required to pay a pro-rated license fee for each portion of the facility which the Company has been granted access until the execution of a lease agreement. The Company cumulatively contributed $7.5 million as part as of landlord works and tenant contributions towards the lease as of September 30, 2023 resulting in these payments being taken into account in the determination of the right of use asset for this facility. On July 31, 2023, the landlord and its contractors accepted practical completion of The Nucleus. On September 19, 2023, the Company entered into a 20 year lease agreement with the landlord for The Nucleus. The Company made fit-out costs in other areas of the building and will be required to be removed at the end of the lease term. As a result, as of September 30, 2023, the Company has recognized an estimated Asset Retirement Obligation ("ARO") amounting to $0.1 million. The following table contains a summary of the lease costs recognized under Accounting Standards Update, "ASU" 2016-02 and other information pertaining to the Company’s operating leases for three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | Lease costs | | 2023 | | 2022 | | 2023 | | 2022 | Operating lease costs | | $ | 2,061 | | | $ | 1,103 | | | $ | 5,235 | | | $ | 3,542 | | Variable costs | | 573 | | | 268 | | | 657 | | | 720 | | Short term lease costs | | 227 | | | 119 | | | 451 | | | 231 | | Total lease costs | | $ | 2,861 | | | $ | 1,490 | | | $ | 6,343 | | | $ | 4,493 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | Nine Months Ended September 30, | Other information | | | | 2023 | | 2022 | Cash paid for amounts included in the measurement of lease liabilities: | | | | | Operating cash outflows from operating leases (in thousands) | | $ | 7,817 | | $ | 3,740 | | | | | | | | | | | | | Weighted-average remaining lease term - operating leases (in years) | | 15.9 years | | 5.1 years | Weighted-average discount rate - operating leases | | 7.44 | % | | 7.18 | % |
Future fixed payments for non-cancellable operating leases in effect as of September 30, 2023 are payable as follows (in thousands): | | | | | | | | | | | | | | | Remainder of 2023 | | | | $ | 1,975 | | 2024 | | | | 8,062 | | 2025 | | | | 6,625 | | 2026 | | | | 6,396 | | 2027 | | | | 6,255 | | Thereafter | | | | 60,424 | | Total lease payments | | | | 89,737 | | Less: imputed interest | | | | (37,279) | | Present value of lease liabilities | | | | $ | 52,458 | |
Sublease Agreements In October 2021, the Company entered into two separate sublease agreements with two third parties for two manufacturing spaces in Enfield which are currently leased by the Company. 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. In October 2021, the Company received $0.1 million in rental deposits, arising from the sub-lease agreements which have been classified as restricted cash as of September 30, 2023 and December 31, 2022, respectively. Both subleases have been classified as operating leases. The Company recognized the sublease payments on a straight-line basis from the commencement of the sublease agreements. The following table shows the sublease rental income for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | Sublease rental income | | 2023 | | 2022 | | 2023 | | 2022 | Sublease rental income (included in other income (expenses), net) | | $ | 61 | | | $ | 57 | | | $ | 181 | | | $ | 183 | | Total sublease rental income | | $ | 61 | | | $ | 57 | | | $ | 181 | | | $ | 183 | |
Future fixed receipts for non-cancellable operating subleases in effect as of September 30, 2023 are receivable as follows (in thousands): | | | | | | | | | Remainder of 2023 | | $ | 65 | 2024 | | $ | 261 | 2025 | | $ | 261 | 2026 | | $ | 203 | 2027 | | $ | 123 | Thereafter | | $ | 106 | Total lease payments receivable | | $ | 1,019 |
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v3.23.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Commitments and Contingencies License Agreements The Company has entered into an exclusive license agreement with UCL Business Ltd, ("UCLB") which has subsequently been amended and restated. 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 and nine months ended September 30, 2023, less than $0.1 million and $0.2 million was paid or payable to UCLB by the Company, respectively, 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 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. In September 2023, the Company entered into a non-exclusive sublicense agreement with Miltenyi Biotech B.V. & Co. KG ("Miltenyi") under which the Company will have the right to develop, manufacture and use Miltenyi's or affiliates' sublicensed 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 in aggregate relating to an upfront license payment and milestone payment which was deemed probable during the three and nine months ended September 30, 2023. The Company recognizes the regulatory, clinical and commercial milestones when probable. The Company concluded that, as of September 30, 2023, there were no other milestones for which the likelihood of achievement was currently probable relating to either of the UCLB, Noile, Adaptive or Miltenyi contracts. 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 September 30, 2023 and December 31, 2022. Capital Commitments As of September 30, 2023, the Company’s unconditional purchase obligations for capital expenditure totaled $4.2 million and include signed orders for capital equipment and capital expenditure for construction and related expenditure relating to its properties in the United Kingdom and the United States. Blackstone Strategic Collaboration and Financing Agreement Refer to Note 10, "Liability related to future royalties and sales milestone, net" for further details to the Blackstone Collaboration Agreement. Leases Lease payments under operating leases as of September 30, 2023 and information about the Company’s lease arrangements are disclosed in Note 11, "Leases".
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v3.23.3
Related parties
|
9 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related parties |
Related parties 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 their right to nominate one director to the board of directors of the Company. As of September 30, 2023, the carrying amount of the Blackstone Collaboration Agreement liability was $140.8 million which included aggregated cumulative non-cash interest expense and cumulative catch-up adjustment of $24.9 million. As of December 31, 2022, the carrying amount of the Blackstone Collaboration Agreement liability was $125.9 million which included aggregated cumulative non-cash interest expense (including cumulative catch-up adjustments), of $10.0 million. Refer to Note 10, "Liability related to sales of future royalties and sales milestone, net" for further details. Syncona Portfolio Limited Syncona Portfolio Limited is a related party of the Company as Syncona Portfolio Limited owns more than 10% of the Company's outstanding voting securities and is therefore one of the principal owners of the Company. In addition, the chair of the ultimate parent company of Syncona Portfolio Limited is also a director of the Company. December 2022 public offering In connection with the Company’s December 2022 public offering, certain of the Company's related parties purchased the Company's ADSs from the underwriters at the public offering price of $2.00 per ADSs, and on the same terms as other investors in the Company's public offering. The following table summarizes purchases of ADS by the Company's related parties: | | | | | | | | | | | | | | | Related party | | ADSs purchased | | Total purchase price (in millions) | Syncona Portfolio Limited (1) | | 14,000,000 | | | $ | 28.0 | | Deep Track Capital, LP (2) | | 15,000,000 | | | 30.0 | | Qatar Investment Authority (3) | | 15,000,000 | | | 30.0 | | Armistice Capital, LLC (4) | | 10,000,000 | | | 20.0 | | Entities affiliated with Blackstone (5) | | 2,500,000 | | | 5.0 | | | | 56,500,000 | | | $ | 113.0 | |
(1) Syncona Portfolio Limited is a holder of more than 10% of the Company's share capital. (2) In connection with this transaction, Deep Track Capital, LP became a holder of more than 5% of the Company's share capital. (3) In connection with this transaction, Qatar Investment Authority became a holder of more than 5% of the Company's share capital. (4) In connection with this transaction, Armistice Capital, LLC became a holder of more than 5% of the Company's share capital. (5) Entities affiliated with Blackstone collectively hold more than 10% of the Company's share capital. Investee of Syncona Portfolio Limited The Company entered into a license agreement with an investee of Syncona Portfolio Limited on September 2, 2020. In addition, the chair of the ultimate parent company of Syncona Portfolio Limited is also a director of the Company. The terms of the agreement include a non-refundable license fee, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. During the three and nine months ended September 30, 2023, Company received variable consideration arising from the achievement of a development milestone amounting to $0.35 million. Consequently, the Company recognized license revenue of $0.35 million (net of foreign exchange differences).
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Subsequent EventsThe Company evaluated subsequent events through November 2, 2023, the date on which these unaudited condensed consolidated financial statements were issued. The Company has concluded that no subsequent event has occurred that requires disclosure.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis of Presentation The accompanying unaudited condensed consolidated financial statements include those of the Company and its wholly owned subsidiaries, Autolus Holdings (UK) Limited, Autolus Limited, Autolus Inc. and Autolus GmbH, and have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany accounts and transactions have been eliminated upon consolidation. The significant accounting policies used in 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 20-F for the year ended December 31, 2022 as filed with the Securities and Exchange Commission on March 7, 2023 (the “Annual Report”). In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, 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, 2022, included in the Annual Report. The Company has incurred recurring losses since its inception, including net losses of $45.8 million and $42.8 million for the three months ended September 30, 2023 and 2022, respectively and $131.2 million and $121.9 million for the nine months ended September 30, 2023 and 2022, respectively. The Company had an accumulated deficit of $801.4 million and $670.2 million as of September 30, 2023 and December 31, 2022, 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 September 30, 2023 of $256.4 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 the going concern basis.
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Foreign Currency Translation |
Foreign Currency Translation The reporting currency of the Company is the U.S. dollar. The Company has determined the functional currency of the ultimate parent company, Autolus Therapeutics plc, is Pound Sterling. The functional currency of subsidiary operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the 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.
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Use of Estimates |
Use of Estimates Lease Term—Impact on Right-of-Use Assets and Lease Liabilities In September 2021, the Company entered into an arrangement for lease with Forge Life Sciences Nominee, an affiliate of the Reef Group, for the design, construction and lease of the Company's new 70,000 square foot commercial manufacturing facility, referred to as, The Nucleus, in Stevenage, United Kingdom. Under this arrangement, the landlord leased the facility to the Company on agreed terms, upon satisfaction of certain conditions and completion of construction. Since November 2022, the landlord has handed over various portions of the facility to the Company until July 31, 2023 when the landlord and the Company accepted practical completion of The Nucleus. The Company was required to pay a pro-rated license fee for each portion of the facility which the Company has been granted access until execution of the lease agreement. As the landlord provided the Company with access to portions of the facility, the definition of a lease in accordance with ASC 842, was met. The lease term can materially impact the value of the right of use assets and lease liabilities recorded on our balance sheet as required under ASC 842. On September 19, 2023, the Company entered into a 20 year lease agreement with Forge Life Sciences Nominee for The Nucleus. The Company calculated the lease term for The Nucleus by taking into account, the noncancellable period specified in the agreement together with the periods a license fee was payable by the Company to the landlord for portions of The Nucleus handed over to the Company.
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Recent Accounting Pronouncements Not Yet Adopted |
Recent Accounting Pronouncements Not Yet AdoptedThere are no new accounting pronouncements that have been issued by the Financial Accounting Standards Board, “FASB”, that are applicable to the Company.
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v3.23.3
License Revenue (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Revenue from Contract with Customer [Abstract] |
|
Schedule of Revenue by Geographic Locations |
Revenue comprised of license revenue for the three and nine months ended September 30, 2023, and 2022 and is represented in the table below by geographical location (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | | 2023 | | 2022 | | 2023 | | 2022 | License revenue | | | | | | | | | United Kingdom | | $ | 346 | | | $ | 60 | | | $ | 346 | | | $ | 60 | | United States | | $ | 60 | | | $ | 2,309 | | | $ | 1,352 | | | $ | 2,309 | | Total license revenue | | $ | 406 | | | $ | 2,369 | | | $ | 1,698 | | | $ | 2,369 | |
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v3.23.3
Prepaid Expenses and Other Current Assets (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
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): | | | | | | | | | | | | | September 30, | | December 31, | | 2023 | | 2022 | Research and development claims receivable | $ | 37,111 | | | $ | 24,685 | | Prepayments | 7,535 | | | 12,337 | | VAT receivable | 2,327 | | | 2,701 | | Other receivable | 2,357 | | | 1,469 | | Deferred cost | 1,911 | | | 1,494 | | Other assets | 127 | | | 203 | | Accounts receivable | 165 | | | 121 | | Total prepaid expenses and other current assets | $ | 51,533 | | | $ | 43,010 | |
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v3.23.3
Property and Equipment, Net (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Depreciation |
Property and equipment, net consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2023 | | 2022 | Lab equipment | $ | 26,362 | | | $ | 31,188 | | Office equipment | 4,416 | | | 3,573 | | Furniture and fixtures | 1,982 | | | 1,221 | | Leasehold improvements | 12,655 | | | 13,583 | | Assets under construction | 18,239 | | | 13,186 | | Less: accumulated depreciation | (29,017) | | | (27,542) | | Total property and equipment, net | $ | 34,637 | | | $ | 35,209 | |
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v3.23.3
Accrued Expenses and Other Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Liabilities |
Accrued expenses and other liabilities consisted of the following (in thousands): | | | | | | | | | | | | | September 30, | | December 31, | | 2023 | | 2022 | Research and development costs | $ | 17,863 | | | $ | 26,478 | | Compensation and benefits | 10,169 | | | 10,181 | | Professional fees | 2,873 | | | 3,745 | | | | | | Other liabilities | 483 | | | 393 | | Total accrued expenses and other liabilities | $ | 31,388 | | | $ | 40,797 | |
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v3.23.3
Share-based Compensation Expense (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Share Based Compensation Expense |
Share-based compensation expense recorded as research and development expenses, general and administrative expenses and capitalized is as follows (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Research and development | $ | 1,525 | | | $ | 1,831 | | | $ | 4,982 | | | $ | 4,802 | | General and administrative | 1,335 | | | 1,506 | | | 2,947 | | | 3,797 | | Capitalized | 4 | | | — | | | 19 | | | — | | Total share-based compensation | $ | 2,864 | | | $ | 3,337 | | | $ | 7,948 | | | $ | 8,599 | |
|
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v3.23.3
Net loss per share (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
Schedule of Earnings Per Share, Basic and Diluted |
Basic and diluted net loss per share attributable to ordinary shareholders was calculated as follows (in thousands, except share and per share amounts): | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | | 2023 | | 2022 | | 2023 | | 2022 | Numerator | | | | | | | | Net loss | $ | (45,849) | | | $ | (42,767) | | | $ | (131,212) | | | $ | (121,888) | | Net loss attributable to ordinary shareholders - basic and diluted | $ | (45,849) | | | $ | (42,767) | | | $ | (131,212) | | | $ | (121,888) | | | | | | | | | | Denominator | | | | | | | | Weighted-average number of ordinary shares used in net loss per share - basic and diluted | 173,984,101 | | | 91,240,801 | | | 173,890,666 | | | 91,028,562 | | Basic and diluted net loss per ordinary share | $ | (0.26) | | | $ | (0.47) | | | $ | (0.75) | | | $ | (1.34) | |
|
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 and Nine Months Ended September 30, | | 2023 | | 2022 | Unvested restricted shares and units | 264,326 | | | 996,927 | | Share options | 14,074,842 | | | 10,421,137 | | Warrants | 3,265,306 | | | 3,265,306 | | Total potentially dilutive securities | 17,604,474 | | | 14,683,370 | |
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v3.23.3
Liability related to sales of future royalties and sales milestones, net (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
Liability Related Debt Arising Financial Agreement |
Changes to the Blackstone Collaboration Agreement liability related to future royalties and sales milestones are as follows: | | | | | | | | | | | | | | | Amount in thousands | | | | | | | | | | | Balance at December 31, 2021 | | | $ | 47,016 | | Proceeds from Blackstone Development Payments received | | 70,000 | | Interest expense accrued on liability related to future royalties and sales milestones, net | | 8,005 | | Cumulative catch-up adjustment | | 879 | | Balance at December 31, 2022 | | | $ | 125,900 | | Interest expense accrued on liability related to future royalties and sales milestones, net | | 14,878 | | Balance at September 30, 2023 | | | $ | 140,778 | |
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v3.23.3
Leases (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Leases [Abstract] |
|
Lease Cost |
The following table contains a summary of the lease costs recognized under Accounting Standards Update, "ASU" 2016-02 and other information pertaining to the Company’s operating leases for three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | Lease costs | | 2023 | | 2022 | | 2023 | | 2022 | Operating lease costs | | $ | 2,061 | | | $ | 1,103 | | | $ | 5,235 | | | $ | 3,542 | | Variable costs | | 573 | | | 268 | | | 657 | | | 720 | | Short term lease costs | | 227 | | | 119 | | | 451 | | | 231 | | Total lease costs | | $ | 2,861 | | | $ | 1,490 | | | $ | 6,343 | | | $ | 4,493 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | | | | | | | | Nine Months Ended September 30, | Other information | | | | 2023 | | 2022 | Cash paid for amounts included in the measurement of lease liabilities: | | | | | Operating cash outflows from operating leases (in thousands) | | $ | 7,817 | | $ | 3,740 | | | | | | | | | | | | | Weighted-average remaining lease term - operating leases (in years) | | 15.9 years | | 5.1 years | Weighted-average discount rate - operating leases | | 7.44 | % | | 7.18 | % |
|
Lease Maturity Schedule |
Future fixed payments for non-cancellable operating leases in effect as of September 30, 2023 are payable as follows (in thousands): | | | | | | | | | | | | | | | Remainder of 2023 | | | | $ | 1,975 | | 2024 | | | | 8,062 | | 2025 | | | | 6,625 | | 2026 | | | | 6,396 | | 2027 | | | | 6,255 | | Thereafter | | | | 60,424 | | Total lease payments | | | | 89,737 | | Less: imputed interest | | | | (37,279) | | Present value of lease liabilities | | | | $ | 52,458 | |
|
Sublease Classification |
The following table shows the sublease rental income for the three and nine months ended September 30, 2023 and 2022 (in thousands): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended September 30, | | Nine Months Ended September 30, | Sublease rental income | | 2023 | | 2022 | | 2023 | | 2022 | Sublease rental income (included in other income (expenses), net) | | $ | 61 | | | $ | 57 | | | $ | 181 | | | $ | 183 | | Total sublease rental income | | $ | 61 | | | $ | 57 | | | $ | 181 | | | $ | 183 | |
|
Lease Receivable Maturity Schedule |
Future fixed receipts for non-cancellable operating subleases in effect as of September 30, 2023 are receivable as follows (in thousands): | | | | | | | | | Remainder of 2023 | | $ | 65 | 2024 | | $ | 261 | 2025 | | $ | 261 | 2026 | | $ | 203 | 2027 | | $ | 123 | Thereafter | | $ | 106 | Total lease payments receivable | | $ | 1,019 |
|
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v3.23.3
Related parties (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Related Party Transactions [Abstract] |
|
Summary of ADSs |
The following table summarizes purchases of ADS by the Company's related parties: | | | | | | | | | | | | | | | Related party | | ADSs purchased | | Total purchase price (in millions) | Syncona Portfolio Limited (1) | | 14,000,000 | | | $ | 28.0 | | Deep Track Capital, LP (2) | | 15,000,000 | | | 30.0 | | Qatar Investment Authority (3) | | 15,000,000 | | | 30.0 | | Armistice Capital, LLC (4) | | 10,000,000 | | | 20.0 | | Entities affiliated with Blackstone (5) | | 2,500,000 | | | 5.0 | | | | 56,500,000 | | | $ | 113.0 | |
(1) Syncona Portfolio Limited is a holder of more than 10% of the Company's share capital. (2) In connection with this transaction, Deep Track Capital, LP became a holder of more than 5% of the Company's share capital. (3) In connection with this transaction, Qatar Investment Authority became a holder of more than 5% of the Company's share capital. (4) In connection with this transaction, Armistice Capital, LLC became a holder of more than 5% of the Company's share capital. (5) Entities affiliated with Blackstone collectively hold more than 10% of the Company's share capital.
|
X |
- DefinitionTabular disclosure of warrants or rights issued. Warrants and rights outstanding are derivative securities that give the holder the right to purchase securities (usually equity) from the issuer at a specific price within a certain time frame. Warrants are often included in a new debt issue to entice investors by a higher return potential. The main difference between warrants and call options is that warrants are issued and guaranteed by the company, whereas options are exchange instruments and are not issued by the company. Also, the lifetime of a warrant is often measured in years, while the lifetime of a typical option is measured in months. Disclose the title of issue of securities called for by warrants and rights outstanding, the aggregate amount of securities called for by warrants and rights outstanding, the date from which the warrants or rights are exercisable, and the price at which the warrant or right is exercisable.
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v3.23.3
Summary of Significant Accounting Policies - Narrative (Details) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
|
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2022
USD ($)
|
Sep. 19, 2023 |
Dec. 31, 2022
USD ($)
|
Sep. 30, 2021
ft²
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
Net loss |
$ (45,849)
|
$ (42,767)
|
$ (131,212)
|
$ (121,888)
|
|
|
|
Accumulated deficit |
(801,391)
|
|
(801,391)
|
|
|
$ (670,179)
|
|
Cash and cash equivalents |
256,415
|
163,053
|
256,415
|
163,053
|
|
$ 382,436
|
|
Foreign currency gain (loss) |
$ (1,700)
|
$ (3,800)
|
$ (400)
|
$ (4,400)
|
|
|
|
Manufacturing Suite in Stevenage, United Kingdom |
|
|
|
|
|
|
|
Lessee, Lease, Description [Line Items] |
|
|
|
|
|
|
|
Number of square feet | ft² |
|
|
|
|
|
|
70,000
|
Operating lease contract term (in years) |
|
|
|
|
20 years
|
|
|
X |
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License Revenue - Disaggregation of Revenue (Details) - License revenue - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
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$ 406
|
$ 2,369
|
$ 1,698
|
$ 2,369
|
United Kingdom |
|
|
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|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total license revenue |
346
|
60
|
346
|
60
|
United States |
|
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|
Disaggregation of Revenue [Line Items] |
|
|
|
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Total license revenue |
$ 60
|
$ 2,309
|
$ 1,352
|
$ 2,309
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License revenue - Narrative (Details)
|
|
3 Months Ended |
6 Months Ended |
9 Months Ended |
Jan. 09, 2023
USD ($)
|
Sep. 30, 2023
USD ($)
performanceObligation
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|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
Distinct performance obligation | performanceObligation |
|
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|
|
|
|
1
|
|
License revenue |
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
Revenue from contract with customer |
|
$ 406,000
|
|
$ 2,369,000
|
|
$ 1,698,000
|
$ 2,369,000
|
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 | Investee of Syncona |
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
Revenue from contract with customer |
|
350,000
|
|
|
|
350,000
|
|
Remaining performance obligation, variable consideration amount |
|
$ 350,000
|
|
|
|
$ 350,000
|
|
Development and Commercialization of mRNA Therapeutics | Moderna |
|
|
|
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
|
|
|
Revenue from contract with customer |
|
|
|
$ 2,200,000
|
|
|
$ 2,200,000
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v3.23.3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Research and development claims receivable |
$ 37,111
|
$ 24,685
|
Prepayments |
7,535
|
12,337
|
VAT receivable |
2,327
|
2,701
|
Other receivable |
2,357
|
1,469
|
Deferred cost |
1,911
|
1,494
|
Other assets |
127
|
203
|
Accounts receivable |
165
|
121
|
Total prepaid expenses and other current assets |
$ 51,533
|
$ 43,010
|
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v3.23.3
Property and Equipment, Net - Schedule of PPE (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment |
|
|
Less: accumulated depreciation |
$ (29,017)
|
$ (27,542)
|
Total property and equipment, net |
34,637
|
35,209
|
Lab equipment |
|
|
Property, Plant and Equipment |
|
|
Property and equipment, gross |
26,362
|
31,188
|
Office equipment |
|
|
Property, Plant and Equipment |
|
|
Property and equipment, gross |
4,416
|
3,573
|
Furniture and fixtures |
|
|
Property, Plant and Equipment |
|
|
Property and equipment, gross |
1,982
|
1,221
|
Leasehold improvements |
|
|
Property, Plant and Equipment |
|
|
Property and equipment, gross |
12,655
|
13,583
|
Assets under construction |
|
|
Property, Plant and Equipment |
|
|
Property and equipment, gross |
$ 18,239
|
$ 13,186
|
X |
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v3.23.3
Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Research and development costs |
$ 17,863
|
$ 26,478
|
Compensation and benefits |
10,169
|
10,181
|
Professional fees |
2,873
|
3,745
|
Other liabilities |
483
|
393
|
Total accrued expenses and other liabilities |
$ 31,388
|
$ 40,797
|
X |
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v3.23.3
Shareholders’ Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions |
1 Months Ended |
|
Nov. 02, 2023 |
Dec. 31, 2022 |
Sep. 30, 2023 |
Unvested restricted shares and units |
|
|
|
Class of Stock |
|
|
|
Vested not issued (in shares) |
|
|
56,269
|
Unvested restricted shares and units | Subsequent Event |
|
|
|
Class of Stock |
|
|
|
Shares issued (in shares) |
52,363
|
|
|
Ordinary shares | Underwriters public offering |
|
|
|
Class of Stock |
|
|
|
Number of shares issued in transaction (in shares) |
|
81,927,012
|
|
Per share price of issuance (usd per share) |
|
$ 2.00
|
|
Proceeds of issuance of ordinary shares, net of issuance costs |
|
$ 152.4
|
|
Ordinary shares | Options |
|
|
|
Class of Stock |
|
|
|
Number of shares issued in transaction (in shares) |
|
6,927,012
|
|
X |
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v3.23.3
Share-based Compensation Expense - Share-based Compensation Allocation (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
Total share-based compensation |
$ 2,864
|
$ 3,337
|
$ 7,948
|
$ 8,599
|
Research and development |
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
Total share-based compensation |
1,525
|
1,831
|
4,982
|
4,802
|
General and administrative |
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
Total share-based compensation |
1,335
|
1,506
|
2,947
|
3,797
|
Capitalized |
|
|
|
|
Share-based Compensation Arrangement by Share-based Payment Award |
|
|
|
|
Total share-based compensation |
$ 4
|
$ 0
|
$ 19
|
$ 0
|
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v3.23.3
Net loss per share - Schedule of Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Numerator |
|
|
|
|
Net loss |
$ (45,849)
|
$ (42,767)
|
$ (131,212)
|
$ (121,888)
|
Net loss attributable to ordinary shareholders - basic |
(45,849)
|
(42,767)
|
(131,212)
|
(121,888)
|
Net loss attributable to ordinary shareholders - diluted |
$ (45,849)
|
$ (42,767)
|
$ (131,212)
|
$ (121,888)
|
Denominator |
|
|
|
|
Weighted-average number of ordinary shares used in net loss per share - basic (in shares) |
173,984,101
|
91,240,801
|
173,890,666
|
91,028,562
|
Weighted-average number of ordinary shares used in net loss per share - diluted (in shares) |
173,984,101
|
91,240,801
|
173,890,666
|
91,028,562
|
Earnings Per Share |
|
|
|
|
Net loss per share - basic (in usd per share) |
$ (0.26)
|
$ (0.47)
|
$ (0.75)
|
$ (1.34)
|
Net loss per share - diluted (in usd per share) |
$ (0.26)
|
$ (0.47)
|
$ (0.75)
|
$ (1.34)
|
X |
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v3.23.3
Net loss per share - Schedule of Anti-dilutive Securities (Details) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Antidilutive Securities |
|
|
|
|
Total potentially dilutive securities (in shares) |
17,604,474
|
14,683,370
|
17,604,474
|
14,683,370
|
Unvested restricted shares and units |
|
|
|
|
Antidilutive Securities |
|
|
|
|
Total potentially dilutive securities (in shares) |
264,326
|
996,927
|
264,326
|
996,927
|
Share options |
|
|
|
|
Antidilutive Securities |
|
|
|
|
Total potentially dilutive securities (in shares) |
14,074,842
|
10,421,137
|
14,074,842
|
10,421,137
|
Warrants |
|
|
|
|
Antidilutive Securities |
|
|
|
|
Total potentially dilutive securities (in shares) |
3,265,306
|
3,265,306
|
3,265,306
|
3,265,306
|
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v3.23.3
Liability related to sales of future royalties and sales milestones, net - Schedule of Liability Related to Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
12 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Liability, Future Revenue [Roll Forward] |
|
|
|
|
|
Interest expense accrued on liability related to future royalties and sales milestones, net |
$ 5,000
|
$ 1,800
|
$ 14,878
|
$ 5,427
|
|
Blackstone Collaboration Agreement |
|
|
|
|
|
Liability, Future Revenue [Roll Forward] |
|
|
|
|
|
Beginning Balance |
|
|
125,900
|
$ 47,016
|
$ 47,016
|
Proceeds from Blackstone Development Payments received |
|
|
|
|
70,000
|
Interest expense accrued on liability related to future royalties and sales milestones, net |
|
|
14,878
|
|
8,005
|
Cumulative catch-up adjustment |
|
|
|
|
879
|
Ending Balance |
$ 140,778
|
|
$ 140,778
|
|
$ 125,900
|
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v3.23.3
Leases - Narrative (Details) € in Thousands |
1 Months Ended |
9 Months Ended |
|
|
|
|
|
Oct. 31, 2021
USD ($)
contract
thirdParty
unit
|
Aug. 31, 2021 |
Mar. 31, 2021
USD ($)
unit
|
Sep. 30, 2017 |
Sep. 30, 2023
USD ($)
manufacturingSuite
|
Sep. 30, 2022
USD ($)
|
Sep. 19, 2023 |
Oct. 31, 2021
EUR (€)
|
Sep. 30, 2021
ft²
|
Feb. 28, 2019
unit
|
Oct. 31, 2018 |
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Manufacturing suite with extended lease term | manufacturingSuite |
|
|
|
|
1
|
|
|
|
|
|
|
Gain (loss) on termination of operating lease |
|
|
|
|
$ (95,000)
|
$ 0
|
|
|
|
|
|
Real estate units split | unit |
|
|
1
|
|
|
|
|
|
|
|
|
Real estate units after split | unit |
|
|
2
|
|
|
|
|
|
|
|
|
Number of contracts | contract |
2
|
|
|
|
|
|
|
|
|
|
|
Payments for tenant improvements |
|
|
|
|
7,500,000
|
|
|
|
|
|
|
ARO |
|
|
|
|
100,000
|
|
|
|
|
|
|
Operating lease, number of third parties | thirdParty |
2
|
|
|
|
|
|
|
|
|
|
|
Number of manufacturing properties | contract |
2
|
|
|
|
|
|
|
|
|
|
|
Total lease payments receivable |
|
|
|
|
1,019,000
|
|
|
|
|
|
|
Proceeds from deposits from customers |
$ 100,000
|
|
|
|
|
|
|
|
|
|
|
Sublease, Lease Term 1 |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Total lease payments receivable | € |
|
|
|
|
|
|
|
€ 97
|
|
|
|
Sublease, Lease Term 2 |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Total lease payments receivable | € |
|
|
|
|
|
|
|
€ 109
|
|
|
|
Manufacturing Suite in Stevenage, United Kingdom |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) on termination of operating lease |
|
|
|
|
(100,000)
|
|
|
|
|
|
|
Loss of disposal on leasehold improvements |
|
|
|
|
$ (3,800,000)
|
|
|
|
|
|
|
Operating lease contract term (in years) |
|
|
|
|
|
|
20 years
|
|
|
|
|
Number of square feet | ft² |
|
|
|
|
|
|
|
|
70,000
|
|
|
Manufacturing Suite in Stevenage, United Kingdom | Manufacturing Facility |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease rent-free period (in months) |
|
|
|
6 months
|
|
|
|
|
|
|
|
Office Space in Rockville, Maryland | Building |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease contract term (in years) |
|
|
|
|
|
|
|
|
|
|
5 years
|
MediaWorks Corporate Headquarters | Additional Space |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease rent-free period (in months) |
|
18 months
|
|
|
|
|
|
|
|
|
|
Operating lease contract term (in years) |
|
9 years 11 months
|
|
|
|
|
|
|
|
|
|
Manufacturing Space in Enfield, United Kingdom |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) on termination of operating lease |
|
|
$ 100,000
|
|
|
|
|
|
|
|
|
Lease termination fee expense |
|
|
$ 200,000
|
|
|
|
|
|
|
|
|
Manufacturing Space in Enfield, United Kingdom | Building |
|
|
|
|
|
|
|
|
|
|
|
Lessor, Lease, Description [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease contract term (in years) |
|
|
|
|
|
|
|
|
|
15 years
|
|
Number of units | unit |
|
|
|
|
|
|
|
|
|
3
|
|
Number of units surrendered | unit |
|
|
1
|
|
|
|
|
|
|
|
|
Number of contracts | unit |
2
|
|
|
|
|
|
|
|
|
|
|
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v3.23.3
Leases - Lease Cost (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Leases [Abstract] |
|
|
|
|
Operating lease costs |
$ 2,061
|
$ 1,103
|
$ 5,235
|
$ 3,542
|
Variable costs |
573
|
268
|
657
|
720
|
Short term lease costs |
227
|
119
|
451
|
231
|
Total lease costs |
$ 2,861
|
$ 1,490
|
6,343
|
4,493
|
Operating cash outflows from operating leases (in thousands) |
|
|
$ 7,817
|
$ 3,740
|
Weighted-average remaining lease term - operating leases (in years) |
15 years 10 months 24 days
|
5 years 1 month 6 days
|
15 years 10 months 24 days
|
5 years 1 month 6 days
|
Weighted-average discount rate — operating leases (percent) |
7.44%
|
7.18%
|
7.44%
|
7.18%
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v3.23.3
Leases - Schedule of Maturity Payments (Details) $ in Thousands |
Sep. 30, 2023
USD ($)
|
Leases [Abstract] |
|
Remainder of 2023 |
$ 1,975
|
2024 |
8,062
|
2025 |
6,625
|
2026 |
6,396
|
2027 |
6,255
|
Thereafter |
60,424
|
Total lease payments |
89,737
|
Less: imputed interest |
(37,279)
|
Present value of lease liabilities |
$ 52,458
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v3.23.3
Commitments and Contingencies - Narrative (Details) - USD ($)
|
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2023 |
Dec. 31, 2022 |
Long-term Purchase Commitment [Line Items] |
|
|
|
Payments for license fees |
$ 100,000
|
$ 200,000
|
|
Loss contingency accrual |
0
|
0
|
$ 0
|
Unconditional purchase obligations for capital expenditures |
4,200,000
|
4,200,000
|
|
Miltenyi Biotech B.V. & Co. KG ("Miltenyi") |
|
|
|
Long-term Purchase Commitment [Line Items] |
|
|
|
Annual license fee |
$ 400,000
|
$ 400,000
|
|
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v3.23.3
Related parties - Narrative (Details) $ / shares in Units, $ in Thousands |
9 Months Ended |
12 Months Ended |
|
|
Sep. 30, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
$ / shares
|
Dec. 31, 2021
USD ($)
|
Nov. 30, 2021
contract
|
Related Party Transaction |
|
|
|
|
Number of directors | contract |
|
|
|
1
|
Contract with customer, liability |
$ 140,800
|
|
|
|
Accrued interest |
24,900
|
|
|
|
Blackstone Collaboration Agreement |
|
|
|
|
Related Party Transaction |
|
|
|
|
Carrying amount of liability |
140,778
|
$ 125,900
|
$ 47,016
|
|
Non-cash interest expense, catch-up |
|
$ 10,000
|
|
|
Syncona LLP | Underwriters public offering |
|
|
|
|
Related Party Transaction |
|
|
|
|
Exercise price of warrant (in usd per share) | $ / shares |
|
$ 2.00
|
|
|
Investee of Syncona | License revenue |
|
|
|
|
Related Party Transaction |
|
|
|
|
Remaining performance obligation, variable consideration amount |
$ 350
|
|
|
|
Autolus | Investee Of Syncona Portfolio Limited | License revenue |
|
|
|
|
Related Party Transaction |
|
|
|
|
Ownership percentage by noncontrolling owners (in percent) |
10.00%
|
|
|
|
Blackstone | Autolus |
|
|
|
|
Related Party Transaction |
|
|
|
|
Ownership percentage by noncontrolling owners (in percent) |
|
|
|
10.00%
|
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v3.23.3
Related parties - Summary of ADS Purchases (Details) $ in Millions |
Sep. 30, 2023
USD ($)
shares
|
Related Party Transaction |
|
ADSs Purchased (in shares) | shares |
56,500,000
|
Total purchase price | $ |
$ 113.0
|
Syncona LLP |
|
Related Party Transaction |
|
ADSs Purchased (in shares) | shares |
14,000,000
|
Total purchase price | $ |
$ 28.0
|
Deep Track Capital, LP |
|
Related Party Transaction |
|
ADSs Purchased (in shares) | shares |
15,000,000
|
Total purchase price | $ |
$ 30.0
|
Qatar Investment Authority |
|
Related Party Transaction |
|
ADSs Purchased (in shares) | shares |
15,000,000
|
Total purchase price | $ |
$ 30.0
|
Armistice Capital, LLC |
|
Related Party Transaction |
|
ADSs Purchased (in shares) | shares |
10,000,000
|
Total purchase price | $ |
$ 20.0
|
Blackstone |
|
Related Party Transaction |
|
ADSs Purchased (in shares) | shares |
2,500,000
|
Total purchase price | $ |
$ 5.0
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