Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
As required by Rules 13a-15 and 15d-15 under the Exchange Act, our Chief Executive Officer and Chief Financial Officer carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of December 31, 2025. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of December 31, 2025, the end of the period covered by this Annual Report on Form 10-K, due to the material weakness in internal control over information technology general controls, or ITGCs, as described below.
Management’s Annual Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act. Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States.
We do not expect that our disclosure controls and procedures, or our internal controls, will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our Company have been detected.
Under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer and oversight of the Board of Directors, our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025, based on the criteria set forth in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 COSO framework). The scope of management’s assessment of the effectiveness of internal controls over financial reporting excluded the business of Fabric Genomics, which the Company acquired in a business combination on May 5, 2025. The Fabric Genomics business represented approximately 1% of total assets (excluding goodwill and intangible assets), 1% of total revenue, and 3% of total operating expenses, as reflected in our consolidated financial statements as of and for the year ended December 31, 2025.
Based on this evaluation, due to the material weakness described below, our management concluded that the Company’s system of internal control over financial reporting was not effective as of December 31, 2025.
Material Weakness
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.
We identified a material weakness in internal control related to deficiencies in the design and operating effectiveness of IT general controls related to segregation of duties in the program change management process for a single IT system that supports certain aspects of our revenue processes. As a result, certain automated controls and business process controls related to recording revenue that are dependent on the affected IT system or the information from such IT system were also deemed ineffective.
Following identification of the material weakness and prior to filing this Annual Report on Form 10-K, we completed procedures to assess the impact to the 2025 financial statements. Based on these procedures, we believe that our consolidated financial statements included in this Form 10-K have been prepared in accordance with U.S. GAAP. Our Chief Executive Officer and Chief Financial Officer have certified that, based on their knowledge, the financial statements, and other financial information included in this Form 10-K, fairly present in all material respects the financial condition, results of operations and cash flows of
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the Company as of, and for, the periods presented in this Form 10-K. Our independent registered public accounting firm, Ernst & Young LLP, has issued an unqualified opinion on our financial statements, which is included in Item 8 of this Form 10-K. Although we have not identified any errors or misstatements in our consolidated financial statements as a result of this material weakness, these deficiencies created a reasonable possibility that a material misstatement of our annual or interim financial statements would not have been prevented or detected on a timely basis as of December 31, 2025.
Planned Material Weakness Remediation Activities
Management is committed to the remediation of the material weakness described above, as well as the continued improvement of our internal control over financial reporting. Our planned remediation efforts related to the material weakness include, but are not limited to:
• Enhancing system settings within the impacted IT application to enforce segregation of duties and align with control design requirements.
• Implementing and formalizing change management and monitoring controls to support improved governance over changes to the affected IT application.
As of the filing date, these remediation actions were implemented. While we believe that the measures already designed and implemented will be sufficient, the material weakness, in the aggregate, will not be considered fully remediated until all aspects of the control operate for a sufficient period of time and we have concluded, through testing, that these controls are operating effectively.
Changes in Internal Control Over Financial Reporting
Other than the identified material weakness and the remediation events discussed above, there were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
Other Information
None.
Rule 10b5-1 Plan Adoptions and Modifications
None of our directors or officers adopted, modified or terminated any “Rule 10b5-1 trading arrangements” or any “non-Rule 10b5-1 trading arrangements,” as each term is defined in Item 408 of Regulation S-K, during the fiscal quarter ended December 31, 2025.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
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Part III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2025.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2025.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2025.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2025.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The information required by this Item is incorporated by reference from our definitive proxy statement for our 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days after the end of our fiscal year ended December 31, 2025.
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Part IV
Item 15. Exhibits, Financial Statement Schedules
a) The following documents are filed as a part of this Annual Report.
1. Consolidated financial statements: The consolidated financial statements are set forth under “Item 8. Financial Statements and Supplementary Data” of this Annual Report on Form 10-K.
2. Financial statement schedules: All schedules have been omitted because they are not required, not applicable, or the required information is included in the consolidated financial statements or notes thereto.
3. Exhibits: The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this Annual Report on Form 10-K.
Incorporated by Reference
No. Description of Exhibit Form Exhibit Filing Date Filed Herewith
1.1 S ales Agree ment, dated October 2 8, 2025, by and between GeneDx Holdings Corp. and TD Securities (USA) LLC .
S-3ASR
1.2 10/28/2025
2.1+ Agreement and Plan of Merger, dated February 9, 2021, by and among CMLS, Merger Sub and Legacy Sema4, as amended by Amendment to Agreement and Plan of Merger dated May 3, 2021.
DEF14M
Annex A
07/02/2021
2.2 Agreement and Plan of Merger and Reorganization, dated as of January 14, 2022, by and among, Orion Merger Sub I, Inc., Orion Merger Sub II, LLC, GeneDx, Inc., GeneDx Holding 2, Inc. and OPKO Health, Inc.
8-K 2.1 01/18/2022
2.3+ Amendment to Agreement and Plan of Merger and Reorganization, dated as of April 29, 2022, by and among, Sema4 Holdings Corp., Orion Merger Sub I, Inc., Orion Merger Sub II, LLC, GeneDx, Inc., GeneDx Holding 2, Inc. and OPKO Health, Inc.
8-K 99.2 05/02/2022
2.4+
A greement and Plan of Merger, by and amo ng GeneDx Holdings Corp., Project Flare Merger Sub, Inc., Fabric Genomics, Inc. and Martin Re ese, dated as of April 15, 2025.
8-K
2.1 04/16/2025
3.1 Third Amended and Restated Certificate of Incorporation, as amended.
8-K 3.1 07/29/2025
3.2
Amended and Restated Bylaws of GeneDx Holdings Corp.
8-K 3.2 01/09/2023
4.1 Specimen Class A Common Stock Certificate.
S-1/A 4.2 08/24/2020
4.2 Specimen Warrant Certificate.
S-1/A 4.3 08/24/2020
4.3 Warrant Agreement, dated as of September 1, 2020, by and between CM Life Sciences, Inc. and Continental Stock Transfer & Trust Company, as warrant agent.
8-K 10.1 09/04/2020
4.4 Warrant to Purchase Stock, dated October 27, 2023, by and among the Company and Perceptive Credit Holdings IV, LP.
8-K 4.1 10/30/2023
4.5 Description of Securities.
X
10.1 Amended and Restated Registration Rights Agreement, dated as of July 22, 2021, by and among the Company, certain equity holders of the Company named therein and certain equity holders of Sema4 named therein.
8-K 10.2 07/28/2021
10.2 Form Director of and Officer Indemnification Agreement.
8-K 10.4 07/28/2021
10.3* GeneDx Holdings Corp. Amended and Restated 2021 Equity Incentive Plan.
8-K 10.1 04/17/2023
10.4* Form of Stock Option Agreement under the 2021 Equity Incentive Plan.
8-K 10.6 07/28/2021
10.5* Form of RSU Agreement under the 2021 Equity Incentive Plan.
8-K 10.7 07/28/2021
10.6* Form of Earn-Out RSU Agreement.
8-K 10.8 07/28/2021
10.7* 2021 Employee Stock Purchase Plan.
8-K 10.9 07/28/2021
10.8* GeneDx Holdings Corp. 2023 Equity Inducement Plan.
8-K 10.1 07/24/2023
10.9* Form of Option Award Agreement under the 2023 Equity Inducement Plan.
8-K 10.2 07/24/2023
10.10* Form of Restricted Stock Unit Award Agreement under the 2023 Equity Inducement Plan.
8-K 10.3 07/24/2023
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10.11 Sub-Sublease, dated as of June 6, 2017, by and between Icahn School of Medicine at Mount Sinai and the Company, as amended July 31, 2019.
8-K 10.17 07/28/2021
10.12 Sublease Agreement, dated as of November 8, 2019, by and between Marriott International, Inc. and the Company.
8-K 10.18 07/28/2021
10.13
Sublease, dated as of April 23, 2019, by and between Icahn School of Medicine at Mount Sinai and the Company.
8-K 10.20 07/28/2021
10.14
Lease Agreement, dated as of January 31, 2020, by and between 1 Commercial Street Associates, LLC and the Company.
8-K 10.21 07/28/2021
10.15+
Lease Agreement, dated as of December 16, 2019, by and between Saul Holdings Limited Partnership and GeneDx, Inc.
X
10.16 Amendment to Lease Agreement, dated as of January 5, 2022, by and between Saul Holdings Limited Partnership and GeneDx, Inc.
X
10.17#
Master Services Agreement, dated as of April 2, 2018, by and among the Company, Icahn School of Medicine at Mount Sinai, The Mount Sinai Hospital, and the parties thereto, as amended July 31, 2019.
8-K 10.22 07/28/2021
10.18#
Master Services Agreement, dated as of May 10, 2018, by and between the Company and Icahn School of Medicine at Mount Sinai, as amended July 31, 2019.
8-K 10.23 07/28/2021
10.19# BioMe Biospecimen and Data Access Agreement, dated as of July 19, 2019, by and between Icahn School of Medicine at Mount Sinai and the Company.
8-K 10.25 07/28/2021
10.20# Non-Exclusive Patent License Agreement, dated as of June 1, 2017, by and between the Company and Icahn School of Medicine at Mount Sinai.
8-K 10.26 07/28/2021
10.21# Supply Agreement, dated as of June 20, 2014, by and between the Company and Illumina, Inc., and amendments thereto.
8-K 10.27 07/28/2021
10.22* Mount Sinai Genomics, Inc. 2017 Equity Incentive Plan, as amended, and forms of equity agreements thereunder.
S-8 99.6 09/27/2021
10.23 Form of Subscription Agreement, dated as of January 14, 2022 by and among the Company and the subscriber parties thereto.
8-K 10.1 01/18/2022
10.24 Form of Shareholder Agreement, dated as of January 14, 2022 by and among the Company and the stockholder parties identified therein.
8-K 10.2 01/18/2022
10.25*
Employment Agreement, dated as of January 14, 2022, as amended April 29, 2022, by and between Sema4 Holdings Corp. and Katherine Stueland.
8-K 10.2 05/02/2022
10.26*
Amendment No. 1 to the Employment Agreement of Kevin Feeley, dated August 25, 2022.
8-K 10.1 08/26/2022
10.27#
Amendment No. 1 to BioMe Biospecimen and Data Access Agreement, dated as of January 19, 2023, by and between Icahn School of Medicine at Mount Sinai and Sema4 OpCo, Inc.
10-K 10.34 03/16/2023
10.28 2022 Replacement Promissory Note.
10-K 10.35 03/16/2023
10.29 Credit Agreement and Guaranty, dated October 27, 2023, by and among the Company and Perceptive Credit Holdings IV, LP.
8-K 10.1 10/30/2023
10.30 Security Agreement, dated October 27, 2023, by and among the Company and Perceptive Credit Holdings IV, LP.
8-K 10.2 10/30/2023
10.31+
Letter Agreement, Amendment No. 2 to Sub-Sublease, dated as of March 20, 2023, by and between Icahn School of Medicine at Mount Sinai and the Company.
10-Q 10.3 05/09/2023
10.32*
Employment Agreement by and between Dr. Bryan Dechairo and GeneDx, LLC, dated as of October 10, 2024.
8-K 10.1 01/02/2025
10.33*
Amended Form of Restricted Stock Unit Award Agreement under the 2023 Equity Inducement Plan.
X
10.34*
N on-Employee Director Compensation Policy, effective April 10, 2025.
10-Q
10.1 07/29/2025
10.35 J oinder Agreement, dated July 2, 2025 by Fabric Genomics, Inc. in favor of Per ceptive Credit Holdings IV, LP.
10-Q
10.2 07/29/2025
10.36 G uarantee Assumption agreement, dated July 2, 2025, by Fabric Genomics, Inc.
10-Q
10.3 07/29/2025
19.1 Insider Trading Policy.
10-K
19.1 02/20/2025
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21.1 Subsidiaries of the Company.
X
23.1 Consent of Ernst & Young LLP, independent registered accounting firm for GeneDx Holdings Corp.
X
24.1 Power of Attorney (included on signature page to this Annual Report on Form 10-K).
X
31.1 Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2 Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a) and 15(d)-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1** Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
32.2** Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
97.1 Policy Relating to Recovery of Erroneously Awarded Compensation.
10-Q
99 07/29/2025
101.INS Inline XBRL Instance Document
X
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.SCH Inline XBRL Taxonomy Extension Schema Document
X
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X
101.LAB Inline XBRL Taxonomy Extension Labels Linkbase Document
X
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X
104 Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.)
X
*
Management Contract or Compensatory Plan
**
Furnished.
+ Certain of the exhibits and schedules to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Company agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request.
# The Company has omitted portions of the exhibit as permitted under Regulation S-K Item 601(b)(10).
Item 16. Form 10-K Summary
We may voluntarily include a summary of information required by Form 10-K under this Item 16. We have elected not to include such summary information.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
GENEDX HOLDINGS CORP.
Date:
February 23, 2026 By: /s/ Katherine Stueland
Name: Katherine Stueland
Title: Chief Executive Officer and Director
(Principal Executive Officer)
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Katherine Stueland, Kevin Feeley and Heidi Chen, and each or any one of them, his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the United States Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature Title Date
/s/ Katherine Stueland Chief Executive Officer and Director February 23, 2026
Katherine Stueland (Principal Executive Officer)
/s/ Kevin Feeley Chief Financial Officer February 23, 2026
Kevin Feeley (Principal Financial Officer)
/s/ Jason Ryan Chairman of the Board February 23, 2026
Jason Ryan
/s/ Eli D. Casdin Director February 23, 2026
Eli D. Casdin
/s/ Emily Leproust Director February 23, 2026
Emily Leproust
/s/ Keith Meister Director February 23, 2026
Keith Meister
/s/ Joshua Ruch Director February 23, 2026
Joshua Ruch
/s/ Richard Pfenninger, Jr. Director February 23, 2026
Richard Pfenninger, Jr.
/s/ Thomas Fuchs
Director February 23, 2026
Thomas Fuchs
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.