autl-20230930

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, 2023


☐			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

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 9, 2023, the registrant had 173,989,157 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, 2023.

The Company has voluntarily elected to file this Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. Per the requirements of Form 10-Q, this Quarterly Report on Form 10-Q includes (i) certifications of the Company’s Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a), (ii) certifications of the Company’s Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14(b) and 15d-14(b), (iii) management’s evaluation and conclusions regarding the effectiveness of the Company’s disclosure controls and procedures as of the period ended September 30, 2023 and (iv) discussion of any changes in the Company’s internal control over financial reporting that occurred during the period ended September 30, 2023 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

As a Foreign Private Issuer, the Company is also exempt from the proxy solicitation rules under Section 14 of the Exchange Act and Regulation FD, and its officers, directors, and principal shareholders are not subject to the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act.

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Part I – Financial Information			6
Item 1. Financial Information			6
Unaudited Condensed Consolidated Balance Sheets as of September 30, 2023 (Unaudited) and December 31, 2022			6
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2023 and 202 2			7
Unaudited Condensed Consolidated Statements of Shareholders’ Equity for the Three and Nine Months Ended September 30, 2023 and 2022			8
Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2023 and 2022			10
Notes to the Unaudited Condensed Consolidated Financial Statements			11
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			23
Item 3. Quantitative and Qualitative Disclosures About Market Risk			36
Item 4. Controls and Procedures			37
Part II – Other Information			37
Item 1. Legal Proceedings			37
Item 1A. Risk Factors			38
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			38
Item 3. Defaults Upon Senior Securities			38
Item 4. Mine Safety Disclosures			38
Item 5. Other Information			38
Item 6. Exhibits			39
Signatures			39

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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.

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

•the development of our 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 ability to advance our product candidates into, and successfully complete, clinical trials;

•our ability to obtain and maintain regulatory approval of our 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;

•the impacts of public health crises like the coronavirus 2019, or COVID-19, and its 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, or CROs, other service providers and collaborators with whom we conduct business;

•our ability to license additional intellectual property relating to our product candidates from third parties and to comply with our existing license agreement;

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

•the potential benefits of our product candidates;

•the timing or likelihood of regulatory filings and approvals for our product candidates, along with regulatory developments in the United States, European Union, the United Kingdom and other foreign countries;

•the size and growth potential of the markets for our product candidates, if approved, and the rate and degree of market acceptance of our 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 conflict between Hamas and Israel, and global geopolitical tension;

•our commercialization, marketing and manufacturing capabilities and strategy;

•our plans to collaborate, or statements regarding our current collaborations;

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

•our expectations regarding our ability to obtain and maintain intellectual property protection;

•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, or ADSs, and the impact of securities analysts’ reports on these prices.

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 inflation and interest rates and unfavorable general market conditions and the impacts of the war in Ukraine, the conflict between Hamas and 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, 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.

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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	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.

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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

Amount