Autolus Therapeutics plc [AUTL] Filings

10-Q 1 autl-20240930.htm 10-Q autl-20240930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2024


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to __________

Commission File Number 001-38547

AUTOLUS THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)


England and Wales			Not applicable
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)

The Mediaworks
191 Wood Lane
London	W12 7FP		United Kingdom
(Address of principal executive offices)

(44) 20		3829 6230
(Registrant's telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing one ordinary share, par value $0.000042 per share	AUTL	The Nasdaq Global Select Market
Ordinary shares, nominal value $0.000042 per share*	*	The Nasdaq Stock Market LLC*


*						Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

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Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “an emerging growth company” in Rule 12b-2 of the Exchange Act:


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☐
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Yes ☐ No ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of November 8, 2024, the registrant had 266,121,689 ordinary shares (including shares in form of ADSs), par value $0.000042 per share, outstanding.

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EXPLANATORY NOTE

Autolus Therapeutics plc (the “Company”) qualifies as a “Foreign Private Issuer,” as defined in Rule 3b-4 under the Securities Exchange Act of 1934 (the “Exchange Act”) and is exempt from filing quarterly reports on Form 10-Q by virtue of Rules 13a-13 and 15d-13 under the Exchange Act. The Company has voluntarily elected to file this Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.

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Part I – Financial Information			6
Item 1. Financial Information			6
Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 (Unaudited)			6
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023 (Unaudited)			7
Condensed Consolidated Statements of Shareholders’ Equity for the Three and Nine Months Ended September 30, 2024 and 2023 (Unaudited)			8
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 (Unaudited)			10
Notes to the Unaudited Condensed Consolidated Financial Statements			12
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			32
Item 3. Quantitative and Qualitative Disclosures About Market Risk			45
Item 4. Controls and Procedures			46
Part II – Other Information			47
Item 1. Legal Proceedings			47
Item 1A. Risk Factors			47
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			98
Item 3. Defaults Upon Senior Securities			98
Item 4. Mine Safety Disclosures			98
Item 5. Other Information			98
Item 6. Exhibits			99
Signatures			100

GENERAL INFORMATION

Unless context otherwise requires, all references in this Quarterly Report on Form 10-Q to “Autolus,” the “Company,” “we,” “us” and “our” refer to Autolus Therapeutics plc and, where appropriate, its consolidated subsidiaries.

Autolus, AUCATZYL® and our other trademarks or service marks appearing in this Quarterly Report on Form 10-Q are our property. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q are referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. Products or service names of other companies mentioned in this Quarterly Report on Form 10-Q may be trademarks, trade names or service marks of their respective owners.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future financial condition, future operations, research and development costs, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

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The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

•the therapeutic potential and expected clinical benefits of AUCATZYL/obe-cel (obecabtagene autoleucel) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (“r/r B-ALL”);

•our ability to generate revenues from AUCATZYL which is dependent upon maintaining significant market acceptance among physicians, patients and healthcare payers;

•our ability to maintain regulatory approval of AUCATZYL in the United States (“US”), to obtain and maintain regulatory approval for obe-cel for adult r/r B-ALL in additional territories and the timing thereof, and to obtain and maintain regulatory approval of our other product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy;

•our expectations regarding the commercialization and marketing of AUCATZYL for adult r/r B-ALL, including expanding into additional territories and the related timing of reaching patients in such territories;

•the development of our commercial product and 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 our research and development programs;

•our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•our commercialization, marketing and manufacturing capabilities and strategy for AUCATZYL, including our ability to successfully recruit and retain sales and marketing personnel and to successfully build the market for AUCATZYL;

•our expectations about the willingness of healthcare providers to recommend AUCATZYL to people with adult r/r B-ALL;

•the impacts of public health crises and their effects on our operations and business, including interruption of key clinical trial activities, such as clinical trial site monitoring, access to capital, and potential disruption in the operations and business of third-party manufacturers, clinical sites, contract research organizations (“CROs”), other service providers and collaborators with whom we conduct business;

•our expectations regarding our ability to obtain and maintain intellectual property protection and our ability to license additional intellectual property relating to our product candidates from third parties and to comply with our existing license agreements;

•our plans to research, develop, manufacture and commercialize our product candidates;

•the potential benefits of our commercial product and product candidates;

•the timing or likelihood of regulatory filings and approvals for our product candidates, along with regulatory developments in the US, European Union (“EU”), the United Kingdom (“U.K.”) and other foreign countries;

•the size and growth potential of the markets for our commercial product and product candidates, if approved, and the rate and degree of market acceptance of our commercial product and product candidates, including reimbursement that may be received from payors;

•our need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflicts involving Israel, and global geopolitical tension;

•our plans to collaborate, or statements regarding our current collaborations with BioNTech SE (“BioNTech”) and others;

•our license and option agreement with BioNTech, including our potential to receive milestone payments and royalties under the agreement;

•our ability to attract collaborators with development, regulatory and commercialization expertise;

•our ability to identify, recruit and retain qualified employees and key personnel;

•our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

•the scalability and commercial viability of our manufacturing methods and processes;

•the success of competing therapies that are or may become available;

•whether we are classified as a Passive Foreign Investment Company (“PFIC”), for current and future periods;

•additional costs and expenses related to our decision to voluntarily comply with certain U.S. domestic issuer reporting obligations before we are required to do so; and

•any other factors which may impact our financial results or future trading prices of our American Depositary Shares (“ADSs”), and the impact of securities analysts’ reports on these prices.

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Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, and involve known and unknown risks, uncertainties and other factors including, without limitation, risks, uncertainties and assumptions regarding the impact of worsening macroeconomic events, including changes in inflation and interest rates and unfavorable general market conditions and the impacts of the war in Ukraine, the conflicts involving Israel, and global geopolitical tensions, on our business, operations, strategy, goals and anticipated timelines, our ongoing and planned preclinical activities, our ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, our timelines for regulatory submissions and our financial position that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You are urged to carefully review the disclosures we make concerning these risks and other factors that may affect our business and operating results in this Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. Except as required by law, we do not intend, and undertake no obligation, to update any forward-looking information to reflect events or circumstances.

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PART I - FINANCIAL INFORMATION

Item 1. Financial statements

AUTOLUS THERAPEUTICS PLC

Unaudited Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)


	Note	September 30, 2024		December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	657,067	$	239,566
Restricted cash		1,470		769
Prepaid expenses and other current assets	7	59,577		34,967
Total current assets		718,114		275,302
Non-current assets:
Property and equipment, net	8	44,258		34,862
Prepaid expenses and other non-current assets		193		380
Long-term deposits		1,033		983
Operating lease right-of-use assets, net		60,503		60,791
Deferred tax asset		3,389		3,063

Total assets		$	827,490	$	375,381
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable		$	1,418	$	103
Accrued expenses and other liabilities	9	47,488		39,581
Operating lease liabilities, current		3,568		5,053
Total current liabilities		52,474		44,737
Non-current liabilities:
Operating lease liabilities, non-current		48,661		47,914
Liabilities related to future royalties and milestones, net	12	248,943		170,899
Other long-term payables		447		357
Total liabilities		350,525		263,907

Commitments and contingencies	14

Shareholders’ equity:
Ordinary shares, $0.000042 par value; 490,909,783 shares authorized as of September 30, 2024 and 290,909,783 as of December 31, 2023; 266,117,277 and 174,101,361, shares issued at September 30, 2024 and December 31, 2023, respectively; 266,119,252 and 174,158,985, shares outstanding at September 30, 2024 and December 31, 2023, respectively		12		8
Deferred shares, £0.00001 par value; 34,425 shares authorized, issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Deferred B shares, £0.00099 par value; 88,893,548 shares authorized, issued and outstanding at September 30, 2024 and December 31, 2023		118		118
Deferred C shares, £0.000008 par value; 1 share authorized, issued and outstanding at September 30, 2024 and December 31, 2023		—		—
Additional paid-in capital		1,549,351		1,018,902
Accumulated other comprehensive loss		(898)		(28,992)
Accumulated deficit		(1,071,618)		(878,562)
Total shareholders’ equity		476,965		111,474
Total liabilities and shareholders’ equity		$	827,490	$	375,381

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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AUTOLUS THERAPEUTICS PLC

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)


		Three Months Ended September 30,				Nine Months Ended September 30,
	Note	2024		2023		2024		2023

License revenue	3	$	—	$	406	$	10,091	$	1,698

Operating expenses:
Research and development		(40,323)		(32,318)		(107,606)		(92,938)
General and administrative		(27,330)		(10,611)		(67,410)		(31,017)
Loss on disposal of property and equipment		(223)		—		(223)		(3,791)
Impairment of operating lease right-of-use assets and related property and equipment		—		(382)		(414)		(382)
Total operating expenses, net		(67,876)		(42,905)		(165,562)		(126,430)

Other income, net		54		136		161		109
Foreign exchange losses		(11,884)		(1,733)		(12,368)		(442)
Interest income		8,320		3,646		24,908		10,495
Interest expense	4	(10,686)		(5,014)		(40,129)		(14,939)
Total other expenses, net		(14,196)		(2,965)		(27,428)		(4,777)
Net loss before income tax		(82,072)		(45,870)		(192,990)		(131,207)
Income tax (expense) benefit		(22)		21		(66)		(5)
Net loss		(82,094)		(45,849)		(193,056)		(131,212)
Other comprehensive income (loss):
Foreign currency exchange translation adjustment		27,010		(5,837)		28,094		5,104
Total comprehensive loss		$	(55,084)	$	(51,686)	$	(164,962)	$	(126,108)

Basic and diluted net loss per ordinary share	5	$	(0.31)	$	(0.26)	$	(0.77)	$	(0.75)
Weighted-average basic and diluted ordinary shares	5	266,084,589		173,984,101		251,480,521		173,890,666

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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AUTOLUS THERAPEUTICS PLC

Unaudited Condensed Consolidated Statements of Shareholders’ Equity

(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 June 30, 2024	266,045,468	$	12	34,425	$	—	88,893,548	$	118	1	$	—	$	1,545,146	$	(27,908)	$	(989,524)	$	527,844

Share-based compensation expense	—	—		—	—		—	—		—	—		4,020		—		—		4,020

Vesting of restricted stock unit awards net of shares withheld to cover tax withholding	3,721	—		—	—		—	—		—	—		—		—		—		—

Exercise of share options	68,088	—		—	—		—	—		—	—		185		—		—		185
Unrealized gain on foreign currency translation	—	—		—	—		—	—		—	—		—		27,010		—		27,010
Net loss	—	—		—	—		—	—		—	—		—		—		(82,094)		(82,094)
Balance at September 30, 2024	266,117,277	$	12	34,425	$	—	88,893,548	$	118	1	$	—	$	1,549,351	$	(898)	$	(1,071,618)	$	476,965


	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 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

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 gain 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

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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AUTOLUS THERAPEUTICS PLC

Unaudited Condensed Consolidated Statements of Shareholders’ Equity

(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, 2023	174,101,361	$	8	34,425	$	—	88,893,548	$	118	1	$	—	$	1,018,902	$	(28,992)	$	(878,562)	$	111,474
Issuance of ordinary shares, net of issuance costs	91,666,669	4		—	—		—	—		—	—		520,613		—		—		520,617
Share-based compensation expense	—	—		—	—		—	—		—	—		9,241		—		—		9,241

Vesting of restricted stock unit awards net of shares withheld to cover tax withholding	134,849	—		—	—		—	—		—	—		—		—		—		—

Exercise of share options	214,398	—		—	—		—	—		—	—		595		—		—		595
Unrealized gain on foreign currency translation	—	—		—	—		—	—		—	—		—		28,094		—		28,094
Net loss	—	—		—	—		—	—		—	—		—		—		(193,056)		(193,056)
Balance at September 30, 2024	266,117,277	$	12	34,425	$	—	88,893,548	$	118	1	$	—	$	1,549,351	$	(898)	$	(1,071,618)	$	476,965


	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	—		—	—		—	—		—	—		—		—		—		—

Exercise of share options	2,071	—		—	—		—	—		—	—		4		—		—		4
Unrealized loss 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

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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AUTOLUS THERAPEUTICS PLC

Unaudited Condensed Consolidated Statements of Cash Flows

(In thousands)


	Nine Months Ended September 30,
	2024		2023
Cash flows from operating activities:
Net loss	$	(193,056)	$	(131,212)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	5,639		4,790
Share-based compensation net of amounts capitalized	9,239		7,929
Interest expense including cumulative catch-up adjustments on liabilities related to future royalties and milestones, net	39,709		14,878
Foreign exchange differences	(13,166)		(366)
Non-cash operating lease expense	3,480		2,963
Loss on termination of operating lease	176		95
Loss on disposal of property and equipment	223		3,812
Impairment of operating lease right-of-use assets and related property and equipment	414		382
Deferred income tax	(326)		(520)

Changes in operating assets and liabilities:
Increase in prepaid expenses and other current assets	(21,851)		(7,655)
Decrease in prepaid expenses and other non-current assets	288		1,932
Decrease in long-term deposits	—		937
Increase in accounts payable	1,259		69
Increase (decrease) in accrued expenses and other liabilities	3,713		(6,823)
Decrease in operating lease liability	(4,078)		(11,965)
Net cash used in operating activities	(168,337)		(120,754)
Cash flows from investing activities:
Purchases of property and equipment	(10,963)		(9,509)
Net cash used in investing activities	(10,963)		(9,509)
Cash flows from financing activities:
Proceeds of issuance of ordinary shares	549,977		—
Payments of equity issuance costs	(29,360)		(910)
Proceeds from the exercise of share options	595		4
Proceeds from liabilities related to future royalties and milestones, net	40,000		—
Payments of issuance costs related to the liabilities related to the sale of future royalties and milestones, net	(1,665)		—
Net cash provided by (used in) financing activities	559,547		(906)
Effect of exchange rate changes on cash, cash equivalents and restricted cash	37,955		5,257
Net increase (decrease) in cash, cash equivalents and restricted cash	418,202		(125,912)
Cash, cash equivalents and restricted cash, beginning of period	240,335		382,761
Cash, cash equivalents and restricted cash, end of period	$	658,537	$	256,849

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	Nine Months Ended September 30,
	2024		2023
Unaudited supplemental cash flow information
Cash paid for income taxes	$	1,263	$	—

Unaudited supplemental non-cash flow information
Property and equipment purchases included in accounts payable or accrued expenses	$	2,889	$	1,389
Leased assets terminated and obtained in exchange for operating lease liabilities, net	$	(975)	$	(1,110)
Leased assets obtained in exchange for operating lease liabilities	$	1,640	$	41,211
Capitalized share-based compensation, net of forfeitures	$	2	$	19
Capitalized implementation costs included in accrued expenses	$	204	$	74




Reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets:
Cash and cash equivalents	$	657,067	$	256,415
Restricted cash	1,470		434
Total cash, cash equivalents and restricted cash	$	658,537	$	256,849

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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AUTOLUS THERAPEUTICS PLC

Notes to the Unaudited Condensed Consolidated Financial Statements

Note 1. Nature of the Business

Autolus Therapeutics plc (with its subsidiaries, collectively, “Autolus” or the “Company”) is an early commercial-stage 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 target cells, break down their defense mechanisms and attack and kill these cells. The Company believes its programmed T cell therapies have the potential to be best-in-class and to offer patients substantial benefits over the existing standard of care, including the potential for cure in some patients. On November 8, 2024 the Company was notified by the U.S. Food and Drug Administration (“FDA”) that the Company’s biologics license application (“BLA”) was approved, allowing for the marketing of AUCATZYL (obecabtagene autoleucel, also known as obe-cel) in the US for the treatment of adult patients (18 years and older) with r/r B-ALL. Obe-cel is under regulatory review in both the European Union (“EU”) and the United Kingdom (“U.K.”) for the treatment of r/r adult B-ALL, with marketing authorization submissions accepted by the European Medicines Agency (“EMA”) in April 2024, and the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) in August 2024.

Autolus Therapeutics plc is registered in England and Wales. Its registered office is The MediaWorks, 191 Wood Lane, London, W12 7FP, United Kingdom.

The Company is subject to risks and uncertainties common to companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. The Company’s product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. Although AUCATZYL has been granted marketing approval in the US by the FDA, the Company will continue to incur significant additional costs to commercialize it. These efforts will require significant amounts of capital, as well as additional personnel, infrastructure, and compliance capabilities. Even if the Company’s product development efforts for obe-cel and its other product candidates are successful, it is uncertain when, if ever, the Company will realize revenue from its product sales.

BioNTech Agreements

On February 6, 2024 (the “Execution Date”), the Company concurrently entered into a (i) Securities Purchase Agreement (the “BioNTech Securities Purchase Agreement”), (ii) a Registration Rights Agreement (the “BioNTech Registration Rights Agreement”), (iii) a Letter Agreement (the “BioNTech Letter Agreement”) and (iv) a License and Option Agreement (the “BioNTech License and Option Agreement”), collectively called the “BioNTech Agreements”, with BioNTech. The BioNTech Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for these agreements in the aggregate. The following descriptions of the BioNTech Agreements do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements.

(i) BioNTech Securities Purchase Agreement

Pursuant to the BioNTech Securities Purchase Agreement the Company sold to BioNTech ADSs, each representing one ordinary share with a nominal value of $0.000042 per share, of the Company (the “Ordinary Shares”) in a private placement transaction (the “Private Placement”). On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs (the “Initial ADSs”), representing 33,333,333 Ordinary Shares at an offering price of $6.00 per Initial ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million.

In the event that BioNTech and the Company enter into a Manufacturing and Commercial Services Agreement (as defined below) within 18 months of the initial closing of the Private Placement, BioNTech will purchase additional ADSs (the “Subsequent ADSs” and, together with the Initial ADSs, the “Private Placement ADSs”), not to exceed 15,000,000 ADSs, for an aggregate purchase price of up to $20.0 million. The total number of Subsequent ADSs that may be issued is subject to additional limitations and restrictions.

The BioNTech Securities Purchase Agreement contains customary representations, warranties, and covenants of each of the Company and BioNTech.

(ii) BioNTech Registration Rights Agreement

Pursuant to the BioNTech Registration Rights Agreement the Company agreed to file a registration statement with the SEC to register the resale of the Private Placement ADSs.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

(iii) BioNTech Letter Agreement

The BioNTech Letter Agreement provides BioNTech with certain additional rights and subjects BioNTech’s investment in the Company to certain restrictions. BioNTech received the right to nominate a director to the Company’s board of directors. If BioNTech acquires beneficial ownership of at least 30% of the issued and outstanding Ordinary Shares of the Company (including in the form of ADSs) within five years of the Execution Date, BioNTech will have the right to designate an additional director who shall be independent. BioNTech’s director nomination rights shall automatically terminate upon BioNTech’s ownership of Ordinary Shares dropping below certain specified percentages. Additionally, BioNTech has the right to purchase equity securities sold by the Company in bona fide financing transactions in amounts that are based on BioNTech maintaining specified ownership thresholds following such financing transactions.

Subject to specified exceptions, BioNTech may not sell the Private Placement ADSs without the Company’s approval for a period of six months following the applicable closing date for such ADSs.

The BioNTech Letter Agreement terminates upon the earlier of (a) the later of (i) February 6, 2027 and (ii) such time as no securities of the Company are held by BioNTech or its affiliates and (b) the consummation of a change of control transaction involving the Company.

(iv) BioNTech License and Option Agreement

License and Options

The Company, through its wholly owned subsidiaries, Autolus Limited and Autolus Holdings (U.K.) Limited, entered into the BioNTech License and Option Agreement with BioNTech pursuant to which the Company granted to BioNTech:

•an exclusive, worldwide, sublicensable license (the “Binder License”) to certain binders and to exploit products that express in vivo such binders (collectively, the “Binder Licensed Products”), and

•several time-limited options (the “Options”) to acquire additional rights to specified clinical-stage product candidates, binders and technologies of the Company, described in more detail below:

◦an option to obtain exclusive rights to co-fund development costs of the Company’s development-stage programs AUTO1/22 and AUTO6NG (“Product Options”), in return for agreed upon economic terms, including an option exercise fee, milestone payments and a profit-sharing arrangement for each such product candidate, with additional options to co-promote or co-commercialize each such product candidate;

◦an option to obtain an exclusive worldwide license to exploit products that express certain additional binders in vivo or, with respect to certain binders, in an antibody drug conjugate (the “Binder Option”);

◦an option to obtain a co-exclusive worldwide license to exploit products that express in vivo the Company’s modules for activity enhancement, with a non-exclusive right, in certain agreed instances, to exploit products that include Company’s modules for activity enhancement but do not express in vivo such modules (the “Activity Enhancement Option”); and

◦an option to obtain a non-exclusive worldwide license to exploit products that contain the Company’s safety switches (the “Safety Switch Option” and, together with the Binder Option and the Activity Enhancement Option, the “Technology Options”).

In consideration for the Binder License and the Technology Options, BioNTech made an initial payment to the Company of $10.0 million. In the event that all Options are fully exercised, the Company would be eligible to receive maximum aggregate payments of up to $582.0 million pursuant to the License Agreement. This maximum amount includes the potential milestone payments for the Binder Licensed Products described below, all option exercise fees and potential milestone payments for licenses to optioned products and technologies, and additional payments that BioNTech may pay to the Company for an increased revenue interest with respect to the Company’s product candidate obe-cel as described below.

The option exercise fee for each Technology Option is a low seven-digit amount. Each of the Activity Enhancement Option and the Safety Switch Option must be exercised with respect to a given biological target or combination of targets. There is a cap on the total option exercise fee if multiple options are exercised with respect to a given target. There is also a cap on milestone payments across all agreements entered into as the result of BioNTech exercising one or more of the Technology Options and a cap on the royalty rate payable on any given product for which multiple Options are exercised.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Obe-cel Product Revenue Interest

BioNTech has also agreed to financially support the expansion of the clinical development program for, and planned commercialization of obe-cel. In exchange for the grant of rights to future revenues from the sales of obe-cel products, BioNTech made an upfront payment to the Company of $40.0 million. The Company will pay BioNTech a low single-digit percentage of annual net sales of obe-cel products, which may be increased up to a mid-single digit percentage in exchange for milestone payments of up to $100.0 million in the aggregate on achievement of certain regulatory events for specific new indications upon BioNTech’s election.

Manufacturing and Commercial Services Agreement

Under the terms of the BioNTech License and Option Agreement, the Company has agreed to grant BioNTech the option to negotiate a joint manufacturing and commercial services agreement pursuant to which the parties may access and leverage each other’s manufacturing and commercial capabilities, in addition to Autolus’ commercial site network and infrastructure, with respect to certain of each parties’ CAR T products, including BioNTech’s product candidate BNT211 (the “Manufacturing and Commercial Services Agreement” or “MCSA”). The MCSA, if entered into, would also grant BioNTech access to the Company’s commercial site network and infrastructure.

The Company concluded there were four freestanding financial instruments arising from the execution of the BioNTech Agreements, comprising:

1.the Initial ADSs representing ordinary shares purchased pursuant to the BioNTech Securities Purchase Agreement;

2.the potential Subsequent ADSs representing ordinary shares that may be purchased pursuant to the BioNTech Securities Purchase Agreement;

3.the BioNTech License and Option Agreement, and

4.the MCSA.

The Subsequent ADSs are classified as a forward instrument contingent on the MCSA being executed. As of September 30, 2024, the MCSA had not been entered into. The forward instrument has an inconsequential market value as the exercise price approximates the Company’s stock price on the last trading day prior to the signing date of the MCSA. Consequently, the initial proceeds arising from the purchase of Initial ADSs pursuant to the BioNTech Securities Purchase Agreement will not be separately allocated to this freestanding financial instrument at inception of the BioNTech Agreements. Furthermore, as the MCSA has yet to be entered into no consideration will be allocated to this freestanding financial instrument at inception of the BioNTech Agreements.

Within the BioNTech License and Option Agreement, there are a number of embedded features which have each been assessed for freestanding financial instrument accounting in accordance with Accounting Standards Codification (“ASC”) 480 – Distinguishing Liabilities from Equity. Although these embedded features are separately exercisable, they lack legal detachability and, therefore, the BioNTech License and Option Agreement is accounted for as one freestanding financial instrument. However, each embedded feature is assessed for derivative accounting in accordance to ASC 815 – Derivative and Hedging (“ASC 815”).

The Company analyzed how it should account for the host contract (i.e., the BioNTech License and Option Agreement) as the Binder License represents an agreement with customer for goods and services and therefore should be accounted for under ASC 606 – Revenue from Contracts with Customers (“ASC 606”). However, as the other embedded features of the BioNTech License and Option Agreement fall under the scope of other topics that specify how to initially measure the contract (i.e., ASC 470 – Debt (“ASC 470”)), the Company determined that the host contract should not be accounted for and initially measured pursuant to ASC 606. Furthermore, the Company determined the host contract (the BioNTech License and Option Agreement) met the scope exception of ASC 815-10-15-59(d) and therefore should not be accounted for as a derivative under ASC 815 but instead be accounted for as a debt financial instrument in accordance with ASC 470.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

The four units of accounting were recorded at fair value upon initial recognition and will not be subsequently measured at fair value. The Company allocated the total gross proceeds arising from the BioNTech Securities Purchase Agreement (i.e. the Initial ADSs representing ordinary shares), and the BioNTech License and Option Agreement among the four units of accounting on a relative fair value basis at the time of the transaction as follows:


Units of Accounting	Gross proceeds (in millions)		Initial fair value (in millions)		Allocated consideration based on relative fair value (in millions)		Net allocated consideration based on relative fair value after transaction costs* (in millions)
Initial ADSs, representing ordinary shares	$	200.0	$	200.0	$	200.0	$	193.8
Subsequent ADSs, representing ordinary shares	$	—	$	—	$	—	$	—
BioNTech License and Option Agreement	$	50.0	$	50.0	$	50.0	$	47.9
Liabilities related to future royalties and milestones, net (Obe-cel Product Revenue Interest)	$	40.0	$	40.0	$	40.0	$	38.3
License Revenue (Binder License)	$	10.0	$	10.0	$	10.0	$	9.6
MCSA	$	—	$	—	$	—	$	—
Total	$	250.0	$	250.0	$	250.0	$	241.7
* In addition, the total shared transaction costs of $8.3 million, relating to the BioNTech Agreements have been allocated to the four units of accounting on a relative fair value basis.

Note 2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the US (“US GAAP”) and are presented in US dollars. All intercompany accounts and transactions between the Company and its subsidiaries have been eliminated upon consolidation.

The significant accounting policies used in the preparation of these unaudited condensed consolidated financial statements are consistent with those discussed in Note 2, “Summary of Significant Accounting Policies” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the Securities and Exchange Commission on March 21, 2024 (the “Annual Report”).

Certain information and footnote disclosures have been condensed or omitted as permitted under US GAAP. The information included in these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto as of and for the year ended December 31, 2023, included in the Annual Report. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year ending December 31, 2024, any other interim periods, or any future year or period.

Going Concern

The Company has incurred recurring losses since its inception, including net losses of $82.1 million and $45.8 million for the three months ended September 30, 2024 and 2023, respectively and $193.1 million and $131.2 million for the nine months ended September 30, 2024 and 2023, respectively. The Company had an accumulated deficit of $1,071.6 million and $878.6 million as of September 30, 2024 and December 31, 2023, respectively. The Company expects to continue to generate operating losses in the foreseeable future. The Company’s inability to raise additional capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all. The Company expects that its cash and cash equivalents at September 30, 2024 of $657.1 million will be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these unaudited condensed consolidated financial statements and accordingly they have been prepared on a going concern basis. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support its cost structure. Even if the Company’s planned regulatory submissions for its products are approved, and the Company is successful in its commercialization efforts, additional funding will be needed before the Company is expected to reach cash breakeven.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Foreign Currency Translation

The reporting currency of the Company is US dollars. The Company has determined that its functional currency of the ultimate parent company, Autolus Therapeutics plc, is British Pound Sterling. The functional currency of each subsidiary’s operations is the applicable local currency. Monetary assets and liabilities denominated in currencies other than the Company’s functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction.

The Company recorded foreign exchange losses of $11.9 million and $1.7 million for the three months ended September 30, 2024 and 2023, respectively, and foreign exchange losses of $12.4 million and $0.4 million for the nine months ended September 30, 2024 and 2023, respectively, which are included in foreign exchange losses in the unaudited condensed Consolidated Statements of Operations and Comprehensive Loss.

For financial reporting purposes, the financial statements of the Company have been translated into US dollars. Assets and liabilities have been translated at the exchange rates at the balance sheet dates, while revenue and expenses are translated at the average exchange rates over the reporting period and shareholders’ equity amounts are translated based on historical exchange rates as of the date of each transaction. Translation adjustments are not included in determining net income (loss) but are included in foreign currency translation to other comprehensive loss, a component of shareholders’ equity.

Segment Information

The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on an integrated basis for the purpose of appropriately allocating resources. When evaluating the Company’s financial performance, the CODM reviews total revenue, total expenses and expenses by function and makes decisions using this information on a global basis. The Company and the CODM view the Company’s operations and manage its business as a single operating segment, which is the business of developing and commercializing CAR T therapies.

Use of Estimates

The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, share-based compensation including assessing the probability of meeting performance conditions, income taxes, initial fair value of warrants, and interest expense on liabilities related to future royalties and milestones, net and related cumulative catch-up adjustment, lease term of the Company’s new manufacturing facility (“The Nucleus”), incremental borrowing rates related to the Company’s leased properties and allocation of transaction price using the relative standalone selling price. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates.

Allocation of transaction price using the relative standalone selling price

Upfront payments are allocated between performance obligations using the Company’s best estimate of the relative standalone selling price of the performance obligation. The relative standalone selling price is estimated by determining the market values of development and license obligations. As these inputs are not directly observable, the estimate is determined considering all reasonably available information including internal pricing objectives used in negotiating the contract, taking into account the different stage of development of each development program and consideration of adjusted-market data from comparable arrangements. Where performance obligations have been identified relating to material rights, the determination of the relative standalone selling price of these performance obligations also includes an assessment of the likelihood that the options will be exercised and any payments by the customer that are triggered upon exercising the right. This assessment involves significant judgment and could have a significant impact on the amount and timing of revenue recognition.

An assessment of the allocation of transaction price using the relative standalone selling price was required for the three and nine months ended September 30, 2024 and 2023 for the BioNTech License and Option Agreement and the Option and License Agreement with Cabaletta Bio Inc. (“Cabaletta”), respectively. See Note 3 for additional information on the allocation of the transaction price for those agreements.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Liabilities related to future royalties and milestones, net and cumulative catch-up adjustments

The Company accounted for each of the Blackstone Collaboration Agreement (See Note 12) (“Blackstone Collaboration Agreement Liability”) and the BioNTech Obe-cel Product Revenue Interest (“BioNTech Liability”) as liabilities measured at amortized cost based on an effective interest rate determined at the outset of the Blackstone Collaboration Agreement Liability related to future royalties and milestones, net is measured based on the Company’s current estimates of the timing and amount of expected future royalties, milestone payments to be paid and the milestones receivable upon the achievement of certain specified clinical, manufacturing and regulatory milestones (each such payment, a “Blackstone Development Payment” and collectively, the “Blackstone Development Payments”) expected to be received over the estimated term of the agreement. Similarly, the BioNTech Liability related to future royalties is measured based on the Company’s current estimates of the timing and amount of expected future royalty expected to be paid over the estimated term of the agreement. Milestone payments pursuant to the BioNTech License and Option Agreement (“BioNTech Milestone Payments”) are payable upon BioNTech’s election, and therefore have not been included in the determination of the effective interest rate or in the measurement of the liability.

The liabilities are amortized using the effective interest rate, resulting in recognition of interest expense over the estimated term of the agreement. Each reporting period the Company assesses the estimated probability, timing and amount of the future expected royalty, milestone payments, the Blackstone Development Payment over the estimated term. If there are changes to the estimates, the Company recognizes the impact to the liability’s amortization schedule and the related interest expense using the cumulative catch-up method.

The Company’s estimate of the probability, timing and amount of expected future royalties and milestones to be paid by the Company and the expected Blackstone Development Payment to be paid to the Company, considers significant unobservable inputs. These inputs include regulatory approval, the estimated patient population, estimated selling price, estimated sales, estimated peak sales and sales ramp, timing of the expected launch and its impact on the royalties as well as the overall probability of a success. Additionally, the transaction costs associated with the liability will be amortized to interest expense over the estimated term of the agreements.

The carrying amount of the Blackstone Collaboration Agreement Liability and BioNTech Liability is based on the Company’s estimate of the future royalties, milestones to be paid to Blackstone by the Company and the expected Blackstone Development Payment to be received over the life of the arrangement as discounted using the initial effective interest rate. The excess estimated present value of future royalties, milestone payments and the future Blackstone Development Payment received over the carrying amount is recognized as a cumulative catch-up adjustment within interest expense using the effective interest rate.

Recent Accounting Pronouncements Not Yet Adopted

In November 2023, the Financial Accounting Standards Board, (“FASB”), issued Accounting Standards Update, or (“ASU”), 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, or (“ASU 2023-07”), which expanded the disclosures for reportable segments made by public entities. These amendments within ASU 2023-07 retained the existing disclosure requirements in ASC 280 - Segment Reporting (“ASC 280”) and expanded upon them to require public entities to disclose significant expenses for reportable segments in both interim and annual reporting periods, as well as items that were previously disclosed only annually on an interim basis, including disclosures related to a reportable segment’s profit or loss and assets. In addition, entities with a single reportable segment must provide all segment disclosures required in ASC 280, including the new disclosures for reportable segments under the amendments in ASU 2023-07. The amendments did not change the existing guidance on how a public entity identified and determined its reportable segments. A public entity should apply the amendments in ASU 2023-07 retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The amendments in ASU 2023-07 are effective for annual periods for all public entities in fiscal years beginning after December 15, 2023, and in interim periods within fiscal years beginning after December 15, 2024. The Company will comply with any new applicable disclosures in its Annual Report on Form 10-K for the year ending December 31, 2024. The Company does not expect the adoption to have a material effect on its financial statements and related disclosures.

In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This ASU improves the transparency of income tax disclosure by requiring consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction. This guidance is effective for the Company for the year beginning January 1, 2025, with early adoption permitted. The amendments should be applied on a prospective basis, with retrospective application permitted. The Company intends to adopt the guidance in the fiscal year beginning January 1, 2025. The Company does not expect the adoption of ASU 2023-09 to have a material effect on its financial statements and related disclosures in this Quarterly Report on Form 10-Q or in its Annual Report on Form 10-K for the full year ending December 31, 2024.

Unless otherwise discussed, the impact of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s consolidated financial statements and disclosures.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Note 3. License Revenue

License revenue for the three and nine months ended September 30, 2024, and 2023, is presented in the table below by geographical location (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
License revenue
United Kingdom	$	—	$	346	$	—	$	346
United States	—		60		—		1,352
Germany	—		—		10,091		—
Total license revenue	$	—	$	406	$	10,091	$	1,698

Major customers

During the nine months ended September 30, 2024, 100% of the Company’s license revenues were generated from BioNTech. For the nine months ended September 30, 2023, 80% and 20% of the Company's license revenues were primarily generated from Cabaletta and an investee of Syncona Portfolio Limited, respectively.

License and Option Agreement with BioNTech

See Note 1 for a description of the BioNTech License and Option Agreement, under which the Company recognized revenue during the nine months ended September 30, 2024. For further details on the terms and accounting treatment considerations for the BioNTech Agreement, refer to following notes to these interim condensed consolidated financial statements:

•Note 1, “Nature of the business”

•Note 2, “Summary of significant accounting policies”

•Note 10, “Shareholders’ equity”

•Note 12, “Liabilities related to future royalties and milestones, net”

•Note 14, “Commitments and contingencies”

As the BioNTech License and Option Agreement has been accounted for as one freestanding financial instrument with various embedded features, including the Binder License and related transfer of know-how, Technology Options, and Product Options, the Company is required to consider if the embedded features are required to be bifurcated from the host contract and therefore accounted for as a separate derivative. The Company concluded the Binder License and related transfer of know-how, Technology Options, and Product Options meet the scope exception set out in ASC 815-10-15-59(d) and therefore not accounted for as derivatives under ASC 815.

Binder License

The Company applied ASC 606 to account for the Binder License and related know-how as functional intellectual property. The Binder License and related transfer of know-how were not distinct from one another and must be combined as a performance obligation, as BioNTech requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one combined distinct performance obligation at the inception of the BioNTech License and Option Agreement.

The Company further determined the consideration received included in the transaction price at contract inception, is to be allocated to the one combined performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and Binder License to BioNTech. The Company recognized total license revenue of $10.1 million (net of foreign exchange differences), related to the BioNTech License and Option Agreement during the three months ended March 31, 2024. No license revenue was recognized during the three months ended September 30, 2024.

The Company is eligible to receive milestone payments of up to $32.0 million in the aggregate upon the achievement of specified clinical development and regulatory milestones for each Binder Licensed Product that achieves such milestones. The Company is also eligible to receive a low single-digit royalty on net sales of Binder Licensed Products, subject to customary reductions, which are subject to specified limits. The royalty will be increased if BioNTech, its affiliates or sublicensees commercialize a Binder Licensed Product in an indication and country in which the Company or its affiliates or licensees also commercializes a product containing the same binders. Under the BioNTech License and Option Agreement, BioNTech is solely responsible for, and has sole decision-making authority with respect to, at its own expense, the exploitation of Binder Licensed Products. Milestone payments and royalty payments are regarded as variable consideration and will be evaluated under the most likely amount method. Milestone payments and royalty payments were not included in the transaction price, as these amounts were fully constrained as of September 30, 2024.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Technology Options

As the Technology Options are outside the scope of ASC 815, the Company considered other relevant accounting guidance to apply to this component of the BioNTech License and Option Agreement. The Company therefore applied ASC 606, considering particularly the accounting guidance related to any options granted to customers to purchase additional goods or services at a future date as this could provide a material right to the customer. A material right is a promise embedded in a current contract that should be accounted for as a separate performance obligation. The Company determined the Technology Options were not offered at a significant and incremental discount. Accordingly, the Technology Options granted to BioNTech do not represent a material right and, therefore, were not a performance obligation at the outset of the arrangement. The Technology Option exercise fee equates to the standalone selling price of the technologies underlying each option and consequently, the transaction price of $10.0 million was not allocated to the Technology Options’ performance obligation. No Technology Options were exercised during the three and nine months ended September 30, 2024.

Product Options

As the Product Options are precluded from being accounted for under ASC 815 due to the scope exception, management considered the terms of the Product Options and concluded that they should be accounted for as a gain contingency under the scope of ASC 450 - Contingencies (“ASC 450”). The Product Options, unlike the Technology Options, are 1) still subject to negotiation as to the specific activities to be performed by each party, which will be determined and agreed before the Product Options can be exercised, and 2) have not been exercised upon signature of the BioNTech License and Option Agreement. As a result, Product Options are not accounted for under to ASC 606, and no recognition is required under ASC 450, until the Product Options are exercised. No Product Options were exercised during the three and nine months ended September 30, 2024.

Option and License Agreement with Cabaletta

On January 9, 2023, the Company entered into an Option and License Agreement (the “Cabaletta Agreement”) with Cabaletta, pursuant to which the Company granted to Cabaletta a non-exclusive license to research, develop, manufacture, have manufactured, use, and commercialize products incorporating the Company’s safety switch technology (the “RQR8 technology”). Upon the execution of the Cabaletta Agreement, the Company made available the RQR8 licensed know-how to Cabaletta for a non-refundable license fee of $1.2 million. The Company has no further material performance obligations related to the Cabaletta Agreement.

The Company further granted to Cabaletta the option to expand the rights and licenses granted under the Cabaletta Agreement to include the research, development, manufacture, use, or commercialization of licensed products up to a predetermined number of target options upon payment of an option exercise fee.

The Company identified the following material promises relating to the granting of a non-exclusive license for research, development, manufacturing and commercialization activities as well as the initial transfer of know-how and information to Cabaletta. The Company determined the option exercise fee is not offered at a significant and incremental discount. Accordingly, the option granted to Cabaletta does not represent a material right and, therefore, is not a performance obligation at the outset of the arrangement. The Company determined that the granting of the research license and the initial transfer of know-how were not distinct from one another and must be combined as a performance obligation, as Cabaletta requires the know-how to derive benefit from the license. Based on these determinations, the Company identified one distinct performance obligation at the inception of the contract.

The Company further determined that the license fee payable constituted the entirety of the consideration included in the transaction price at contract inception, which was allocated to the one performance obligation. The amount of the transaction price allocated to the performance obligation is recognized as or when the Company satisfies the performance obligation. The Company determined that the performance obligation was recognized at a point-in-time, upon the delivery of the transfer of know-how and research license to Cabaletta. The Company recognized total license revenue of $1.2 million related to the Cabaletta Agreement for the nine months ended September 30, 2023. No license revenue was recognized related to the Cabaletta Agreement for the three and nine months ended September 30, 2024.

Upon execution of the Cabaletta Agreement, the transaction price included only the $1.2 million non-refundable license fee payable to the Company. The Company may receive further payments upon the exercise of the options for licensed targets, the achievement of certain development and sales milestones, as well as royalty payments based on net sales of each product covered by the licensed intellectual property.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

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 $0.4 million. Consequently, the Company recognized license revenue of $0.4 million (net of foreign exchange differences) for the three and nine months ended September 30, 2023.

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, 2024. For the three and nine months ended September 30, 2024 and 2023, the Company has not recognized any variable consideration with regards to the development milestones and sales-based milestones with its customers as they are deemed not probable.

Note 4. Interest expense

Interest expense consisted of the following (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Interest expense on liabilities related to future royalties and milestones, net (refer to Note 12)	$	10,280	$	5,014	$	28,839	$	14,878
Cumulative catch-up adjustment arising from the liabilities related to future royalties and milestones, net (refer to Note 12)	—		—		10,870		—
Other interest expense	406		—		420		61
Total interest expense	$	10,686	$	5,014	$	40,129	$	14,939

Note 5. Net loss per ordinary share

Basic and diluted net loss per ordinary share was calculated as follows (in thousands, except share and per share amounts):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Numerator
Net loss	$	(82,094)	$	(45,849)	$	(193,056)	$	(131,212)
Net loss - basic and diluted	$	(82,094)	$	(45,849)	$	(193,056)	$	(131,212)

Denominator
Weighted-average number of ordinary shares used in net loss per share - basic and diluted	266,084,589		173,984,101		251,480,521		173,890,666
Basic and diluted net loss per ordinary share	$	(0.31)	$	(0.26)	$	(0.77)	$	(0.75)

For all periods presented, outstanding but unvested restricted stock units, share options and warrants 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.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

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,
	2024	2023
Unvested restricted stock units	36,186	264,326
Share options	20,382,429	14,074,842
Warrants	3,265,306	3,265,306
Total potentially dilutive securities	23,683,921	17,604,474

Note 6. Fair value measurements

The Company uses valuation approaches that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines the fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in of the following levels:

• Level 1 — Quoted prices in active markets for identical assets or liabilities.

• Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.

• Level 3 — Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.

The carrying amounts reported in the balance sheet for cash and cash equivalents, restricted cash, prepaid expenses and other assets, accounts payable and accrued expenses and other liabilities approximate their fair value because of the short-term nature of these instruments.

The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):


	September 30, 2024
	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Financial assets
Cash and cash equivalents:
Money market funds	$	596,387	$	596,387	$	—	$	—
Total	$	596,387	$	596,387	$	—	$	—


	December 31, 2023
	Total		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Financial assets
Cash and cash equivalents:
Money market funds	$	184,635	$	184,635	$	—	$	—
Total	$	184,635	$	184,635	$	—	$	—

During the three and nine months ended September 30, 2024 and the year ended December 31, 2023, there were no transfers between fair value levels.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Note 7. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Research and development claims receivable	$	34,766	$	19,209
Prepayments	14,057		8,638
VAT receivable	3,140		2,771
Deferred cost	2,237		1,787
Other taxes receivable	1,678		—
Accrued interest income	1,409		999
Lease deposit receivable	993		938
Corporate tax receivable	699		—
Other receivables	598		516
Accounts receivable	—		109
Total prepaid expenses and other current assets	$	59,577	$	34,967

Note 8. Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Lab equipment	$	42,857	$	32,232
Office equipment	5,571		3,777
Furniture and fixtures	2,519		2,360
Leasehold improvements	15,055		12,728
Assets under construction	13,513		12,539
Less: accumulated depreciation	(35,257)		(28,774)
Total property and equipment, net	$	44,258	$	34,862

Depreciation expense for the three months ended September 30, 2024 and 2023 was $1.9 million and $1.4 million, respectively, and for the nine months ended September 30, 2024 and 2023 was $5.6 million and $4.8 million, respectively.

Note 9. Accrued Expenses and Other Liabilities

Accrued expenses and other liabilities consisted of the following (in thousands):


	September 30,		December 31,
	2024		2023
Research and development costs	$	20,093	$	19,825
Compensation and benefits	15,444		14,757
Professional fees	7,584		4,466
VAT accrual	3,964		—

Other accrued liabilities	403		533
Total accrued expenses and other liabilities	$	47,488	$	39,581

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Note 10. 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, 2024, the Company has not declared any dividends.

Restricted Stock Units

At September 30, 2024, restricted stock unit awards for 1,975 ordinary shares had vested but the underlying shares had not been issued. However, these vested restricted stock unit awards have been included in the calculation of the Company’s outstanding shares at September 30, 2024 as they are considered issuable for little or no cash consideration. Subsequent to September 30, 2024, all of the underlying ordinary shares were issued.

February 2024 Underwritten Offering

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

BioNTech Securities Purchase Agreement

Concurrently with the execution of the BioNTech License and Option Agreement (see Note 1 and Note 3), the Company and BioNTech entered into the BioNTech Securities Purchase Agreement pursuant to which the Company sold ADSs, each representing one ordinary share, to BioNTech in a Private Placement transaction. On February 13, 2024, the Company completed the Private Placement of 33,333,333 ADSs representing 33,333,333 ordinary shares at an offering price of $6.00 per ADS. Aggregate net proceeds to the Company, after underwriting discounts and offering expenses, were $193.8 million.

In the event that BioNTech and the Company enter into the MCSA within 18 months of the initial closing of the Private Placement, BioNTech will purchase up to 15,000,000 ADSs for an aggregate purchase price of up to $20.0 million, subject to additional limitations and restrictions.

Note 11. Share-based Compensation

The following table summarizes the total share-based compensation expense included in the unaudited condensed consolidated statements of operations and comprehensive loss (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	1,218	$	1,525	$	2,716	$	4,982
General and administrative	2,802		1,335		6,525		2,947
Capitalized	—		4		(2)		19
Total share-based compensation expense	$	4,020	$	2,864	$	9,239	$	7,948

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Share Options

The table below summarizes Company’s share option activity during the nine months ended September 30, 2024:


	Number of Options	Weighted- Average Exercise Price per share		Weighted- Average Remaining Contractual Term (Years)	Aggregate Intrinsic Value (1) (in thousands)













Outstanding as of December 31, 2023	17,956,385	$	5.64	8.35	$	48,968
Granted	3,797,650	4.19			268
Exercised	(214,398)	2.77			480
Forfeited	(902,906)	3.30			857
Expired	(254,302)	9.41			5
Outstanding as of September 30, 2024	20,382,429	$	5.45	7.98	$	13,411
Exercisable as of September 30, 2024	8,879,183	$	8.13	6.88	$	4,561
Vested and expected to vest as of September 30, 2024	20,382,429	$	5.45	7.98	$	13,411

(1) Aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of ordinary shares for those options in the money as of September 30, 2024

During the nine months ended September 30, 2024, the Company modified the exercise period of 571,352 share options resulting in the recognition of incremental share-based compensation expense of $0.4 million.

The total intrinsic value of options exercised was $0.5 million for the nine months ended September 30, 2024.

The weighted average grant-date fair value of share options granted was $3.02 per share option for the nine months ended September 30, 2024.

As of September 30, 2024, the total unrecognized compensation expense related to unvested share options without performance conditions was $13.5 million, which the Company expects to recognize over a weighted average vesting period of 3.04 years.

As of September 30, 2024, the total unrecognized share-based compensation expense related to unvested share options with performance conditions was $2.9 million, which the Company expects to recognize when the performance condition becomes probable.

Restricted Stock Units

The table below summarizes Company’s restricted stock unit (“RSU”) awards activity during the nine months ended September 30, 2024:


	Number of restricted units	Weighted average grant date fair value












Unvested and outstanding at December 31, 2023	116,436	$	3.43

Vested	(79,200)	2.94
Forfeited	(1,050)	6.20
Unvested and outstanding at September 30, 2024	36,186	$	4.43

As of September 30, 2024, there was less than $0.1 million of unrecognized share-based compensation expense related to unvested RSUs without performance conditions, which is expected to be recognized over a weighted average period of 1.44 years.

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AUTOLUS THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued

Note 12. Liabilities related to future royalties and milestones, net


	Amount in thousands
Balance at 1 January, 2023	$	125,900
Interest expense on liability related to future royalties and milestones, net	4,905
Balance at March 31, 2023	$	130,805
Interest expense on liability related to future royalties and milestones, net	4,959
Balance at June 30, 2023	$	135,764
Interest expense on liability related to future royalties and milestones, net	5,014
Balance at September 30, 2023	$	140,778
Interest expense on liability related to future royalties and milestones, net	5,014
Cumulative catch-up adjustment	25,107
Balance at December 31, 2023	$	170,899
Initial recognition of BioNTech liability	38,335
Interest expense on liability related to future royalties and milestones, net	8,390
Cumulative catch-up adjustment	10,870
Balance at March 31, 2024	$	228,494
Interest expense on liability related to future royalties and milestones, net	10,169
Balance at June 30, 2024	$	238,663
Interest expense on liability related to future royalties and milestones, net	10,280

Balance at September 30, 2024	$	248,943

During the three months ended September 30, 2024 and 2023, interest expense on liabilities related to future royalties and milestones, net amounted to $10.3 million and $5.0 million, respectively. During the nine months ended September 30, 2024 and 2023, interest expense on liabilities related to future royalties and milestones, net amounted to $28.8 million and $14.9 million, respectively.

During the three months ended September 30, 2024 and 2023 and nine months ended September 30, 2023, there was no cumulative catch-up adjustment (included in interest expense). During the nine months ended September 30, 2024, the cumulative catch-up adjustment amounted to $10.9 million.

Blackstone Collaboration Agreement

On November 6, 2021, the Company concurrently entered into the following agreements with BXLS V - Autobahn L.P, (“Blackstone”): (i) Strategic Collaboration Agreement (the “Blackstone Collaboration Agreement”), (ii) Securities Purchase Agreement (the “Blackstone Securities Purchase Agreement”), (iii) Warrant Agreement (the “Blackstone Warrant”) and (iv) a Registration Rights Agreement (the “Blackstone Registration Rights Agreement”). The Blackstone Collaboration Agreement, the Blackstone Securities Purchase Agreement, the Blackstone Warrant and the Blackstone Registration Rights Agreement are collectively referred to as the “Blackstone Agreements”. The Blackstone Agreements were entered into and in contemplation of one another and, accordingly, the Company assessed the accounting for the Blackstone Agreements in the aggregate.

For further details on the terms and accounting treatment considerations for these contracts, please refer to following notes to the Company’s consolidated financial statements contained in the Company’s Annual Report:

•Note 2, “Summary of significant accounting policies”

•Note 11, “Liability related to future royalties and milestones, net”

•Note 12, “Warrants”

•Note 13, “Shareholders’ equity”

Autolus Therapeutics plc [AUTL] Filings
10-Q	[2024-11-12]
10-Q	[2024-08-08]
10-Q	[2024-05-17]
10-K	[2024-03-21]
10-Q	[2023-11-09]
20-F	[2023-03-07]
20-F	[2022-03-10]
20-F	[2021-03-04]
20-F	[2020-03-03]
F-1	[2019-04-08]
20-F	[2019-02-25]
20-F	[2018-11-23]
F-1	[2018-05-07]