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Item 9A. Controls and Procedures

2025-03-13 compared with 2024-03-14 · 59 added, 65 removed, 358 unchanged (26% of the section changed)

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As of December 31, 2024, management, with the participation of our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act.

Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures.

Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures.

Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Based on this evaluation, and as a result of the material weakness described below, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2023, our disclosure controls and procedures were not effective at a reasonable assurance level.

Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2024, the design and operation of our disclosure controls and procedures were effective at a reasonable assurance level.

Management’s Annual Report on Internal Control Over Financial Reporting

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Management has assessed the effectiveness of our internal control over financial reporting based on the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013 framework).

Based on our evaluation, and as a result of the material weakness described below, management has concluded that our internal control over financial reporting was not effective as of December 31, 2023.

Based on our evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2024.

Inherent Limitations of Internal Controls

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Also, projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Material Weaknesses

Prior Material Weakness

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual and interim financial statements will not be detected or prevented on a timely basis.

As described in Note 1 of the Consolidated Financial Statements under the paragraph Restatement of Financial Statements, the Company re-evaluated its prior accounting for shares received in the License Agreement and Share Purchase Agreement entered into on December 14, 2020, with Allogene Overland.

As described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (Annual Report), which was filed with the Securities and Exchange Commission (SEC) on March 14, 2024, Note 1 of the Consolidated Financial Statements under the paragraph Restatement of Financial Statements, the Company re-evaluated its prior accounting for shares received in the License Agreement and Share Purchase Agreement entered into on December 14, 2020, with Allogene Overland.

Upon reassessment, the Company has determined that the 49% of Allogene Overland's Seed Preferred Shares received as a partial consideration for the License Agreement should be initially measured at fair value.

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Remediation Measures

We have identified and begun to implement steps, as further described below, designed to remediate the foregoing material weakness.

We will not consider the material weakness remediated until our controls are operational for a sufficient period of time and tested, enabling management to conclude that the controls are operating effectively.

To remediate this material weakness, we are in the process of improving the operation of our controls related to the technical accounting analysis of significant non-routine transactions which includes engaging third-party subject matter experts with significant relevant experience.

While the foregoing measures are intended to effectively remediate the material weakness described in this Item 9A, it is possible that additional remediation steps will be necessary.

As such, as we continue to evaluate and implement our plan to remediate the material weakness, our management may decide to take additional measures to address the material weakness or modify the remediation steps described above.

Until this material weakness is remediated, we plan to continue to perform additional analyses and other procedures to help ensure that our consolidated financial statements are prepared in accordance with GAAP.

We identified and implemented steps designed to remediate the foregoing material weakness.

We finalized the design and operation of our controls related to the technical accounting analysis of significant non-routine transactions which includes hiring personnel in our accounting with an appropriate level of knowledge and experience to effectively perform technical accounting analysis of significant non-routine transactions, in addition to, engaging third-party subject matter experts with significant relevant experience.

As of December 31, 2024, we validated the effectiveness of controls with respect to the technical accounting analysis of significant non-routine transactions.

The applicable controls have been in operation for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.

Accordingly, the material weakness associated with technical accounting analysis of significant non-routine transactions was remediated as of December 31, 2024.

Changes in Internal Control over Financial Reporting

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Changes may include such activities as implementing new, more efficient systems, consolidating activities, and migrating processes.

There were no changes in our internal control over financial reporting that occurred during the most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There were key changes to our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the year ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

These changes are discussed above in our remediation measures.

Other Information.

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from the Hebrew University Hadassah Medical School in Jerusalem before completing his post graduate studies in Immunology at the Weizmann Institute of Science and his residency in Urologic Surgery at Harvard Medical School.

David Bonderman, 81, has served as a member of our Board since April 2018.

He is a Founding Partner and Chairman of TPG, a global alternative asset firm, established in 1992.

Bonderman currently serves on the board of directors of TPG, Inc., a public company.

He has previously served on the boards of many public companies, some of which include:

RyanAir Holdings, plc and Continental Airlines, for both of which he was Chairman, Ducati Motor Holding, S.p.A, China International Capital Corporation Limited, Co-Star Group, Inc., General Motors Company, Kite Pharma, Inc., Oxford Health Plans, Inc., Paradyne Networks, Inc., Seagate Technology Holdings plc, TPG Pace Tech Opportunities Corp., TPG Pace Solutions Corp., TPG Pace Energy Holdings Corp., TPG Pace Holdings, Inc., TPG Pace Beneficial Finance Corp., and Univision Holdings, Inc.

Throughout Mr.

Bonderman’s career, he has served as a director on numerous other public, private, advisory, academic and charitable boards.

Bonderman received a Bachelor of Arts degree from the University of Washington, cum laude, and a J.D.

from Harvard Law School, magna cum laude, where he was a member of the Harvard Law Review and Sheldon Fellow.

David Chang, M.D., Ph.D.

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He has also served as a Venture Partner of Vida Ventures, LLC since November 2017, and Two River, LLC since October 2017.

In addition, he serves as a member of the American Association for Cancer Research Oncology Development Fund Investment Advisory Committee,

CalTech Cheng Medical Engineering Advisory Council and of the MIT Corporation Biology Visiting Committee.

In addition, he serves as a member of the American Association for Cancer Research Oncology Development Fund Investment Advisory Committee, CalTech Cheng Medical Engineering Advisory Council and of the MIT Corporation Biology Visiting Committee.

Chang obtained a B.S.

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In addition, Dr.

Humer serves on the board of directors of the International Centre for Missing and Exploited Children and is Chair of the Humer Foundation.

serves on the board of directors of the International Centre for Missing and Exploited Children and is Chair of the Humer Foundation.

Humer previously served as Chair of the board of directors of Neogene Therapeutics, Inc., a private research-stage biotechnology company, from October 2020 until January 2023 and as a member of the board of directors of Kite from September 2015 until October 2017.

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since January 2019.

Messemer is a certified public

accountant and joined KPMG LLP ("KPMG"), the U.S.

Messemer is a certified public accountant and joined KPMG LLP ("KPMG"), the U.S.

member firm of KPMG International, in 1982 and was admitted into the partnership in 1995.

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She was a professor of management practice at Harvard Business School from September 2006 to July 2017 and was a professor in the Department of Molecular and Cell Biology at Harvard University from July 2005 until October 2015.

Previously, she served as President of Vertex Pharmaceuticals, Inc.

Previously, she served as President of Vertex

Pharmaceuticals, Inc.

("Vertex"), a publicly-traded biotechnology company, which she joined in 1992.

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Chang, our executive officers include the following:

Timothy Moore, 62, has served as our Executive Vice President, Chief Technical Officer since April 24, 2023.

Previously, Mr.

Moore served as the Chief Operating Officer of Instil Bio from September 2022 to December 2022, President and Chief Operating Officer at PACT Pharma, Inc.

from April 2020 to July 2022, and as the President and Chief Technology Officer at PACT from October 2019 to April 2020.

Prior to PACT, Mr.

Moore served as Executive Vice President, Technical Operations of Kite Pharma, or Kite, a Gilead Company, from March 2016 to September 2019.

Prior to Kite, he spent more than 12 years at Genentech, a Roche Company, most recently as Senior Vice President, Head of Global Technical Operations – Biologics and as a member of the Genentech Executive Committee.

He holds a B.S.

in Chemical Engineering from Tulsa University and an M.S.

from Northwestern University.

Zachary Roberts, M.D., Ph.D.

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Prior to joining Kite, Dr.

Roberts served in various roles in Amgen, with his last position as Clinical Research Medical Director for

Amgen Oncology from January 2015 to July 2015.

Roberts served in various roles in Amgen, with his last position as Clinical Research Medical Director for Amgen Oncology from January 2015 to July 2015.

Roberts completed his training in internal medicine and hematology/oncology at the Massachusetts General Hospital and Dana Farber Cancer Institute.

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In addition, Mr.

Parker currently serves as a member of the board of directors of Better Therapeutics and of Perrigo Company plc.

Parker currently serves as a member of the board of directors of Perrigo Company plc.

He earned an A.B.

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from Columbia University School of Law.

Benjamin Beneski , 48, has served as our Senior Vice President and Chief Technical Officer since March 2025.

Beneski joined Allogene in 2019 as our Executive Director and Plant Manager, where he played a pivotal role in the design, construction, and successful startup of Cell Forge 1, our state-of-the-art cell therapy manufacturing facility.

Since then, Mr.

Beneski has advanced through a series of increasingly senior roles, including Vice President of Manufacturing and Vice President of Product Development and Manufacturing where he led the development of next-generation platforms, effectively managed internal and external manufacturing networks, and drove key initiatives to support IND submissions and ensure commercial readiness.

Prior to joining Allogene, Mr.

Beneski held senior manufacturing roles at various biotechnology companies, including Vir Biotechnology and Amgen.

He earned B.S.

in chemical engineering from Stevens Institute of Technology and an MBA from Northeastern University.

We have adopted a code of ethics for directors, officers (including our principal executive officer, principal financial officer and principal accounting officer) and employees, known as the Code of Business Conduct and Ethics.

The Code of Business Conduct and Ethics is available on our website at http://www.allogene.com under the Governance section of our Investors page.

We will promptly disclose on our website (i) the nature of any amendment to the policy that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (ii) the nature of any waiver, including an implicit waiver, from a provision of the policy that is granted to one of these specified individuals, the name of such person who is granted the waiver and the date of the waiver.

In addition, we intend to promptly disclose on our website, to the extent required by the rules and regulations of the SEC, (i) the nature of any amendment to the Code of Business Conduct and Ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, and (ii) the nature of any waiver, including an implicit waiver, from a provision of the Code of Business Conduct and Ethics that is granted to one of these specified individuals, the name of such person who is granted the waiver and the date of the waiver.

Stockholders may request a free copy of the Code of Business Conduct and Ethics from our Compliance Officer, c/o Allogene Therapeutics, Inc., 210 E.

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333-227333), filed with the SEC on October 2, 2018).

10.7+ Non-Employee Director Compensation Policy.

10.8+ Employment Agreement by and between the Registrant and David Chang, M.D., Ph.D.

10.7+ Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.7 to the Registrant’s Annual Report on Form 10-K (File No.

001-38693), filed with the SEC on March 14, 2024).

10.8+ Employment Agreement , dated June 25, 20 18, by and between the Registrant and David Chang, M.D., Ph.D.

(incorporated by reference to Exhibit 10.12 to the Registrant’s Registration Statement on Form S-1, as amended (File No.

333-227333), filed with the SEC on September 14, 2018).

10.9+ Consulting Agreement, dated April 29, 2023, by and between the Registrant and Alison Moore, Ph.D.

(incorporated by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-38693), filed with the SEC on May 3, 2023).

10.10+ First Amendment to Consulting Agreement, dated December 16, 2023, by and between the Registrant and Alison Moore, Ph.D.

10.9+ Employment Letter of Agreement, dated December 28, 2022, by and between the Registrant and Zachary Roberts, M.D., Ph.D.

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001-38693), filed with the SEC on February 2 8 , 202 3 ).

10.12+ Employment Letter of Agreement, dated April 18, 2023, by and between the Registrant and Timothy Moore (incorporated by reference to Exhibit 10.

3 to the Registrant’s Quarterly Report on Form 10-Q (File No.

001-38693), filed with the SEC on May 3, 2023) .

10.10+ Employment Letter of Agreement, dated August 11, 2023, by and between the Registrant and Earl Douglas (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No.

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001-38693), filed with the SEC on May 7, 2019).

10.16† Exclusive License and Collaboration Agreement, dated October 30, 2015, by and between the Registrant (assignee of Pfizer Inc.) and Les Laboratoires Servier and Institut de Recherches Internationales Servier (incorporated by reference to Exhibit 10.7 to the Registrant’s Registration Statement on Form S-1, as amended (File No.

333-227333), filed with the SEC on September 17, 2018).

10.13*‡ Exclusive License and Collaboration Agreement, dated October 30, 2015, by and between the Registrant (assignee of Pfizer Inc.) and Les Laboratoires Servier and Institut de Recherches Internationales Servier .

10.14* Amendment and Settlement Agreement, dated May 10, 2024, by and between Les Laboratoires Servier, Institut de Recherches Internationales Servier and Allogene Therapeutics, Inc.

(incorporated by reference to Exhibit 10.4 to the Registrant's Quarterly Report on Form 10-Q (File No.

001-38693), filed with the SEC on August 7, 2024).

10.15* Asset Contribution Agreement, dated April 2, 2018, by and between the Registrant and Pfizer Inc.

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10.16* Amended and Restated Collaboration and License Agreement, dated January 17, 2024, by and between the Registrant and Notch Therapeutics Inc.

(incorporated by reference to Exhibit 10.18 to the Registrant’s Annual Report on Form 10-K (File No.

001-38693), filed with the SEC on March 14, 2024).

10.17 Lease, dated August 1, 2018, by and between the Registrant and Britannia Pointe Grand Limited Partnership (incorporated by reference to Exhibit 10.11 to the Registrant’s Registration Statement on Form S-1, as amended (File No.

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001-38693) for the year ended December 31, 2020, filed with the SEC on February 25, 2021).

First Amendment to the License Agreement, dated May 24, 2024, by and between Allogene Therapeutics Inc.

and Allogene Overland BioPharm (PRC) Co., Limited (incorporated by reference to Exhibit 10.3 to the Registrant's Quarterly Report on Form 10-Q (File No.

001-38693), filed with the SEC on August 7, 2024).

Share Purchase Agreement, dated December 14, 2020, by and among the Registrant, Overland Pharmaceuticals (CY) Inc.

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001-38693) for the quarter ended June 30, 2022, filed with the SEC on August 9, 2022).

Shareholders' Agreement, dated December 14, 2020, by and among the Registrant, Overland Pharmaceuticals (CY) Inc.

and Allogene Overland Biopharm (CY) Limited (incorporated by reference to Exhibit 10.25 to the Registrant’s Annual Report on Form 10-K (File No.

001-38693) for the year ended December 31, 2020, filed with the SEC on February 25, 2021).

Strategic Collaboration Agreement, dated January 3, 2024, by and between Foresight Diagnostics, Inc.

and the Registrant

Amended and Restated Shareholders' Agreement, dated May 24, 2024, by and among Allogene Overland Biopharm (CY) Limited, Allogene Therapeutics Inc.

and HH BioPharma Holdings Ltd.

(incorporated by reference to Exhibit 10.2 to the Registrant's Quarterly Report on Form 10-Q (File No.

001-38693), filed with the SEC on August 7, 2024).

Share Exchange Agreement, dated May 24, 2024, by and among Allogene Overland Biopharm (CY) Limited, Overland Pharmaceuticals (CY) Inc.

and Allogene Therapeutics Inc.

(incorporated by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q (File No.

001-38693), filed with the SEC on August 7, 2024).

19.1 Allogene Therapeutics, Inc.

Insider Trading Policy

23.1 Consent of Independent Registered Public Accounting Firm.

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97.1 Allogene Therapeutics, Inc.

Incentive Compensation Recoupment Policy

Incentive Compensation Recoupment Policy (incorporated by reference to Exhibit 97 .

1 to the Registrant’s Annual Report on Form 10-K (File No.

001-38693), filed with the SEC on March 14, 2024).

101.INS Inline XBRL Instance Document

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+ Indicates management contract or compensatory plan.

† Confidential treatment has been granted with respect to certain portions of this exhibit.

Omitted portions have been filed separately with the Securities and Exchange Commission

* Certain portions of this exhibit (indicated by “[***]”) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K because it is both not material and is the type of information that the Registrant treats as private or confidential.

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/s/ Geoffrey Parker Chief Financial Officer March 13, 2025

Geoffrey Parker ( Principal Financial and Accounting Officer )

/s/ Arie Belldegrun, M.D., FACS Executive Chair of the Board of Directors March 14, 2024

Arie Belldegrun, M.D., FACS

Geoffrey Parker ( Principal Financial Officer )

/s/ Annie Yoshiyama Senior Vice President and Corporate Controller March 13, 2025

Annie Yoshiyama (Principal Accounting Officer)

/s/ Arie Belldegrun, M.D.

Executive Chair of the Board of Directors March 13, 2025

Arie Belldegrun, M.D.

/s/ Elizabeth Barrett Member of the Board of Directors March 13, 2025

Elizabeth Barrett

/s/ David Bonderman Member of the Board of Directors March 14, 2024

David Bonderman

/s/ John DeYoung Member of the Board of Directors March 13, 2025

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures