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Autolus Therapeutics plc

For the period ended Mar 31, 2024. Filed May 17, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2024 · Filed May 17, 2024

AUTL$1.32+3.1%Stored close · as of Nov 9, 2026

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Table of contents

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 March 31, 2024.

TABLE OF CONTENTS

Part I – Financial Information5
Item 1. Financial Information5
Condensed Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023 (Unaudited)5
Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2024 and 2023 (Unaudited)6
Condensed Consolidated Statements of Shareholders’ Equity for the Three Months Ended March 31, 2024 and 2023 (Unaudited)7
Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2024 and 2023 (Unaudited)8
Notes to the Unaudited Condensed Consolidated Financial Statements10
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations28
Item 3. Quantitative and Qualitative Disclosures About Market Risk39
Item 4. Controls and Procedures40
Part II – Other Information41
Item 1. Legal Proceedings41
Item 1A. Risk Factors41
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds42
Item 3. Defaults Upon Senior Securities42
Item 4. Mine Safety Disclosures42
Item 5. Other Information42
Item 6. Exhibits42
Signatures43

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 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 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 (“EU”), the United Kingdom (“U.K.”) 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 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 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 (“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 in 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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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.