What changed in this filing

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Item 9A. Controls and Procedures

2025-02-28 compared with 2024-02-28 · 250 added, 64 removed, 152 unchanged (67% of the section changed)

4 unchanged sentences

In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Based on such evaluation, our principal executive officer and principal financial officer concluded that, as of December 31, 2023, in light of the material weaknesses identified in our internal control over financial reporting, our disclosure controls and procedures were not effective at the reasonable assurance level and are not effective to provide reasonable assurance that information required to be disclosed in the reports we file and submit under the Exchange Act, is (i) recorded, processed, summarized and reported as and when required and (ii) accumulated and communicated to our management, including the principal executive officer and principal financial officer, as appropriate to allow timely discussion regarding required disclosure.

Management’s Annual Report on Internal Control over Financial Reporting

Based on such evaluation, our principal executive officer and principal financial officer concluded that, as of December 31, 2024, in light of the material weakness identified in our internal control over financial reporting, our disclosure controls and procedures were not effective at the reasonable assurance level and are not effective to provide reasonable assurance that information required to be disclosed in the reports we file and submit under the Exchange Act, is (i) recorded, processed, summarized and reported as and when required and (ii) accumulated and communicated to our management, including the principal executive officer and principal financial officer, as appropriate to allow timely discussion regarding required disclosure.

Management’s Report on Internal Control Over Financial Reporting

Management, including our principal executive officer and principal financial officer, is responsible for establishing and maintaining adequate internal control over financial reporting.

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In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in the 2013 Internal Control-Integrated Framework.

Based on our assessment, management has concluded that our system of internal control over financial reporting was not effective due to the material weaknesses described below.

However, after giving full consideration to these material weaknesses, and the additional analyses and other procedures we performed to ensure that our consolidated financial statements included in this Annual Report on Form 10-K were prepared in accordance with U.S.

Based on our assessment, management has concluded that our system of internal control over financial reporting was not effective due to the material weakness described below.

However, after giving full consideration to the material weakness and the additional analyses and other procedures we performed to ensure that our consolidated financial statements included in this Annual Report on Form 10-K were prepared in accordance with U.S.

generally accepted accounting principles or GAAP, our management has concluded that our consolidated financial statements present fairly, in all material respects, our financial position, results of operations and cash flows for the periods disclosed in conformity with GAAP.

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 our annual or interim financial statements will not be prevented or detected on a timely basis.

As of December 31, 2023, the following material weaknesses have been identified:

General Information Technology Controls.

We did not design and maintain effective general information technology controls, or GITCs, for information systems and applications that are relevant to the preparation of the consolidated financial statements.

Specifically, we did not design and maintain:

(i) sufficient user access controls to ensure appropriate segregation of duties, logical access controls to prevent unauthorized user access and adequately restrict user and privileged access to financial applications, programs and data to appropriate Company personnel;

(ii) program change management controls to ensure that information technology, or IT, program and data changes affecting financial IT applications and underlying accounting records are identified, tested, authorized and implemented appropriately with appropriate segregation of duties;

and (iii) computer and network operations controls to ensure that batch and interface jobs are monitored and privileges are appropriately granted, authorized and monitored.

As a result, business process controls (automated and manual) that are dependent on the ineffective GITCs, or that rely on data produced from systems impacted by the ineffective GITCs, are also deemed ineffective, which affects substantially all financial statement account balances and disclosures.

Purchase Order Approval Workflow.

We did not design and maintain effective process-level control activities related to procurement to ensure appropriate approval of purchase orders, which could affect the amount and classification of costs capitalized or expensed.

As of December 31, 2024, the following material weakness has been identified:

COSO Framework .

We did not fully maintain components of the COSO framework, including elements of the control environment, information and communication, and control activities and monitoring activities components, relating to:

(i) sufficiency of competent personnel to perform internal control activities and support the achievement of our internal control objectives;

(ii) enforcing accountability of personnel for the performance of their internal control responsibilities across the

organization in the pursuit of objectives;

(iii) designing and maintaining general control activities over technology to support the achievement of our internal control objectives;

(iv) performing control activities in accordance with established policies in a timely manner;

and (v) performing sufficient reviews of information to assess its relevance, accuracy, and completeness in supporting the internal control components.

As such, our management concluded that we did not have an adequate process in place to complete its assessment of the design and operating effectiveness of internal control over financial reporting in a timely manner.

Remediation of Prior Year Material Weaknesses

As disclosed in Part II, Item 9A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on February 27, 2023, we previously identified material weaknesses related to GITCs, purchase order approval workflow and the COSO framework.

During the fiscal year ended December 31, 2023, we implemented an intensive program to remediate the previously identified material weaknesses, which included expanding resources, including hiring a Chief Information and Security Officer in the third quarter of 2023, enhancing our control activities for key systems and business processes, and providing training.

In addition, we performed manual procedures to validate the completeness and accuracy of the reports generated from the systems that are relevant to the preparation of the consolidated financial statements that did not have effective GITCs.

While we believe that we have completed updates to the control design for the majority of our systems and purchase order approval workflow in response to the identified material weaknesses, the redesigned controls did not operate for a sufficient period of time for management to reach a conclusion regarding the operating effectiveness of the controls that were redesigned in the fiscal year ended December 31, 2023.

However, our management concluded these material weaknesses did not result in any material misstatement in our financial statements or disclosures for the fiscal year ended December 31, 2023.

We did not fully maintain components of the COSO framework, including elements of the control environment, risk assessment, control activities, and monitoring activities components, relating to (i) sufficiency of competent personnel to perform internal control activities and support the achievement of our internal control objectives;

(ii) monitoring and risk assessment are performed to monitor and identify risks related to complex and/or non-routine transactions;

and (iii) performing control activities in accordance with established policies in a timely manner.

Specifically, we determined that insufficient risk assessment was performed to identify risks related to complex and/or non-routine transactions and financial reporting personnel failed to perform control activities and to provide necessary oversight and monitoring of the accounting and reporting of complex and/or non-routine transactions.

This control deficiency creates a reasonable possibility that a material misstatement of our consolidated financial statements would not be prevented or detected on a timely basis and constitutes a material weakness in our internal control over financial reporting.

This material weakness resulted in immaterial corrected errors in the reporting of stock-based compensation expense as presented within Part II Item 9B of this Annual Report on Form 10-K.

Management's Plan to Remediate the Material Weakness

Our management is committed to maintaining a strong internal control environment.

In response to the material weaknesses described above, our management is continuing to take actions to remediate the material weaknesses in internal control over financial reporting, which include but are not limited to the following:

• Continuing to enhance the design and control procedures of the GITCs to ensure that the control activities related to GITCs are functioning appropriately.

In response to the material weakness described above, our management is continuing to take actions to remediate the material weakness in internal control over financial reporting, which include but are not limited to the following:

• Continuing to implement training to ensure a clear understanding of risk assessment, control execution, and monitoring activities related to financial reporting and continue driving accountability of Sarbanes-Oxley Act of 2002 control activities.

• Continuing to focus on controls execution and monitoring activities of internal controls related to the procure-to-pay process.

• Continuing to expand the available resources at the Company with experience designing and implementing control activities, including GITCs, through hiring and use of third-party consultants and specialists.

We are committed to continuing to implement a strong system of controls and believe that our ongoing remediation efforts, particularly in the improvement of our control environment, will result in significant improvements to our system of controls that we believe will remediate the material weaknesses.

However, material weaknesses are not considered remediated until the new controls have been operational for a period of time, are tested, and management concludes that these controls are operating effectively.

• Updating our internal accounting policies and engaging resources at the Company with experience in performing control activities over complex and/or non-routine transactions, through hiring and/or use of third-party consultants and specialists.

• Enhancing the design of controls related to stock-based equity compensation, specifically around the recognition of stock-based equity compensation expense as outlined in ASC718.

This remediation process may require additional resources and will require time to implement.

We will continue to monitor the effectiveness of these remediation measures, and we will make any changes to the design of our remediation plans and take such other actions that we deem appropriate given the circumstances.

Remediation of Prior Year Material Weaknesses

We previously identified material weaknesses related to General Information Technology Controls (GITCs), the purchase order approval workflow and the COSO framework.

During the fiscal year ended December 31, 2024, we implemented an intensive program to remediate the material weaknesses which included expanding resources, enhancing our control activities for key systems and business processes, and providing comprehensive training.

While we have remediated the material weaknesses related to our GITCs and the purchase order approval workflow, as discussed above we did not fully maintain components of the COSO framework.

Attestation Report of the Independent Registered Public Accounting Firm

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OTHER INFORMATION

During the fiscal quarter ended December 31, 2023, none of our directors or officers (as defined in Section 16 of the Securities Exchange Act of 1934, as amended) adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(a) of Regulation S-K.

Immaterial Correction of Interim Condensed Consolidated Financial Statements

During the fiscal quarter ended December 31, 2023, the Company entered into consulting agreements with two former executives.

Pursuant to their consulting agreements, the two former executives were granted additional equity awards and the previously granted unvested awards were modified to vest in full upon the contractual end of their consulting agreements in the fiscal quarter ended December 31, 2024.

The accounting for the vesting of the unvested shares and consulting agreement shares was not appropriately recorded over the service period reflected in the consulting agreements under ASC 718, Compensation – Stock Compensation .

Management evaluated the above misstatements and concluded they were not material to the Company's financial statements, individually or in the aggregate;

however, the Company plans to correct its condensed consolidated financial statements for the interim periods of 2024 as presented below.

The following tables present a summary of the effects of the correction of the Company’s previously issued condensed consolidated financial statements to be presented as comparative financial information in the Form 10-Q for nine months ending September 30, 2025:

Condensed Consolidated Statements of Operations (unaudited)

Three Months Ended September 30, 2024

Nine Months Ended September 30, 2024

(in thousands)

As Previously Reported

General and administrative

$ 28,515 $ 3,229 $ 31,744 $ 83,104 $ 9,687 $ 92,791

Total operating expenses

93,375 3,229 96,604 281,133 9,687 290,820

Loss from operations

(10,492) (3,229) (13,721) (33,927) (9,687) (43,614)

Loss before income taxes

(7,208) (3,229) (10,437) (25,322) (9,687) (35,009)

Net loss $ (7,408) $ (3,229) $ (10,637) $ (25,461) $ (9,687) $ (35,148)

Net loss per share

Basic $ (0.14) $ (0.06) $ (0.20) $ (0.49) $ (0.18) $ (0.67)

Diluted $ (0.14) $ (0.06) $ (0.20) $ (0.49) $ (0.18) $ (0.67)

Condensed Consolidated Statements of Comprehensive Loss (unaudited)

Three Months Ended September 30, 2024

Nine Months Ended September 30, 2024

(in thousands)

As Previously Reported

Net loss $ (7,408) $ (3,229) $ (10,637) $ (25,461) $ (9,687) $ (35,148)

Comprehensive loss (6,623) (3,229) (9,852) (25,677) (9,687) (35,364)

Condensed Consolidated Statement of Stockholders' Equity (unaudited)

Nine Months Ended September 30, 2024

(in thousands)

Additional Paid-in Capital Accumulated Deficit Total Stockholders' Equity

As Previously Reported

Balance at December 31, 2023

$ 946,511 $ (678,269) $ 261,328

Employee stock-based compensation expense 40,090 — 40,090

Net loss — (25,461) (25,461)

Balance at September 30, 2024 984,627 (704,252) 273,246

Employee stock-based compensation expense 9,687 — 9,687

Net loss — (9,687) (9,687)

Balance at December 31, 2023

946,511 (678,269) 261,328

Employee stock-based compensation expense 49,777 — 49,777

Net loss — (35,148) (35,148)

Balance at September 30, 2024 $ 994,314 $ (713,939) $ 273,246

Condensed Consolidated Statement of Cash Flows (unaudited)

Nine Months Ended September 30, 2024

(in thousands)

As Previously Reported

Net loss $ (25,461) $ (9,687) $ (35,148)

Stock-based compensation $ 40,208 $ 9,687 $ 49,895

Condensed Consolidated Statements of Operations (unaudited)

Three Months Ended June 30, 2024

Six Months Ended June 30, 2024

(in thousands)

As Previously Reported

General and administrative

$ 27,678 $ 3,229 $ 30,907 $ 54,589 $ 6,458 $ 61,047

Total operating expenses

96,372 3,229 99,601 187,758 6,458 194,216

Loss from operations

(4,098) (3,229) (7,327) (23,435) (6,458) (29,893)

Loss before income taxes

(1,372) (3,229) (4,601) (18,114) (6,458) (24,572)

Net loss $ (1,394) $ (3,229) $ (4,623) $ (18,053) $ (6,458) $ (24,511)

Net loss per share

Basic $ (0.03) $ (0.06) $ (0.09) $ (0.35) $ (0.12) $ (0.47)

Diluted $ (0.03) $ (0.06) $ (0.09) $ (0.35) $ (0.12) $ (0.47)

Condensed Consolidated Statements of Comprehensive Loss (unaudited)

Three Months Ended June 30, 2024

Six Months Ended June 30, 2024

(in thousands)

As Previously Reported

Net loss $ (1,394) $ (3,229) $ (4,623) $ (18,053) $ (6,458) $ (24,511)

Comprehensive loss (1,250) (3,229) (4,479) (19,054) (6,458) (25,512)

Condensed Consolidated Statement of Stockholders' Equity (unaudited)

Six Months Ended June 30, 2024

(in thousands)

Additional Paid-in Capital Accumulated Deficit Total Stockholders' Equity

As Previously Reported

Balance at December 31, 2023

$ 946,511 $ (678,269) $ 261,328

Employee stock-based compensation expense 26,417 — 26,417

Net loss — (18,053) (18,053)

Balance at June 30, 2024 969,427 (696,844) 264,669

Employee stock-based compensation expense 6,458 — 6,458

Net loss — (6,458) (6,458)

Balance at December 31, 2023

946,511 (678,269) 261,328

Employee stock-based compensation expense 32,875 — 32,875

Net loss — (24,511) (24,511)

Balance at June 30, 2024 $ 975,885 $ (703,302) $ 264,669

Condensed Consolidated Statement of Cash Flows (unaudited)

Six Months Ended June 30, 2024

(in thousands)

As Previously Reported

Net loss $ (18,053) $ (6,458) $ (24,511)

Stock-based compensation $ 26,514 6,458 32,972

Condensed Consolidated Statement of Operations (unaudited)

Three Months Ended March 31, 2024

(in thousands)

As Previously Reported

General and administrative

$ 26,911 $ 3,229 $ 30,140

Total operating expenses

91,386 3,229 94,615

Loss from operations

(19,337) (3,229) (22,566)

Loss before income taxes

(16,742) (3,229) (19,971)

Net loss $ (16,659) $ (3,229) $ (19,888)

Net loss per share

Basic $ (0.32) $ (0.06) $ (0.38)

Diluted $ (0.32) $ (0.06) $ (0.38)

Condensed Consolidated Statement of Comprehensive Loss (unaudited)

Three Months Ended March 31, 2024

(in thousands)

As Previously Reported

Net loss $ (16,659) $ (3,229) $ (19,888)

Comprehensive loss $ (17,804) (3,229) (21,033)

Condensed Consolidated Statement of Stockholders' Equity (unaudited)

March 31, 2024

(in thousands)

Additional Paid-in Capital Accumulated Deficit Total Stockholders' Equity

As Previously Reported

Balance at December 31, 2023 $ 946,511 $ (678,269) $ 261,328

Employee stock-based compensation expense 13,295 — 13,295

Net loss — (16,659) (16,659)

Balance at March 31, 2024 959,734 (695,450) 256,225

Employee stock-based compensation expense 3,229 — 3,229

Net loss — (3,229) (3,229)

Balance at December 31, 2023 946,511 (678,269) 261,328

Employee stock-based compensation expense 16,524 — 16,524

Net loss — (19,888) (19,888)

Balance at March 31, 2024 $ 962,963 $ (698,679) $ 256,225

Condensed Consolidated Statement of Cash Flows (unaudited)

Three Months Ended March 31, 2024

(in thousands)

As Previously Reported

Net loss $ (16,659) $ (3,229) $ (19,888)

Stock-based compensation $ 13,344 $ 3,229 $ 16,573

Trading Arrangements

During the three months ended December 31, 2024, except as set forth below, none of our directors or officers (as defined in Section 16 of the Exchange Act) adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement,” as defined in Item 408(c) of Regulation S-K.

On December 13, 2024 , John W.

Hanna , our Chief Executive Officer , adopted a trading plan intended to satisfy the conditions under Rule 10b5-1(c) of the Exchange Act.

Hanna’s plan is for the sale of up to 297,755 shares of common stock in amounts and prices determined in accordance with a formula set forth in the plan and terminates on the earlier of the date that all the shares under the plan are sold and March 27, 2026 , subject to early termination for certain specified events set forth in the plan.

On December 12, 2024 , Hannah Valantine , our board member , adopted a trading plan intended to satisfy the conditions under Rule 10b5-1(c) of the Exchange Act.

Valantine’s plan is for the sale of up to 44,756 shares of common stock in amounts and prices determined in accordance with a formula set forth in the plan and terminates on the earlier of the date that all the shares under the plan are sold and December 31, 2025 , subject to early termination for certain specified events set forth in the plan.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

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To the extent that we do not file the 2025 Proxy Statement by such date, we will file an amendment to this Annual Report on Form 10-K that includes the information required by this Item 10.

Our Board of Directors has adopted Corporate Governance Guidelines.

These guidelines address items such as the qualifications and responsibilities of our directors and director candidates and corporate governance policies and standards applicable to us in general.

In addition, our Board of Directors has adopted a Code of Business Conduct and Ethics that applies to all of our employees, officers and directors, including our Chief Executive Officer, Chief Financial Officer, and other executive and senior financial officers.

The full text of our Corporate Governance Guidelines and our Code of Business Conduct and Ethics is posted on our website at www.caredx.com in the Corporate Governance section of our Investors webpage.

We intend to post any amendments to our Code of Business Conduct and Ethics, and any waivers of our Code of Business Conduct and Ethics for directors and executive officers, on the same website.

Our Board of Directors has adopted an insider trading policy.

Our insider trading policy prohibits our directors, officers (including our executive officers), employees and agents, as well as their immediate family members, from engaging in short sales of our securities and from engaging in transactions in publicly-traded options and other derivative securities with respect to our securities.

This prohibition extends to any hedging or similar transactions designed to decrease the risks associated with holding our securities.

Our insider trading policy also prohibits certain individuals, including our directors and executive officers, from pledging our securities as collateral for loans.

A couple of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.

EXECUTIVE COMPENSATION

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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The information required by this item is incorporated by reference to from the information contained in the 2024 Proxy Statement.

The information required by this item is incorporated by reference from the information contained in the 2025 Proxy Statement.

The 2025 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024.

1 unchanged sentence

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE

The information required by this item is incorporated by reference to from the information contained in our 2024 Proxy Statement.

The information required by this item is incorporated by reference from the information contained in our 2025 Proxy Statement.

The 2025 Proxy Statement will be filed with the SEC within 120 days after the end of the fiscal year ended December 31, 2024.

17 unchanged sentences

10-Q 001-36536 3.1 8/28/2014

3.2 Certificate of Amendment to the Amended and Restated Certificate of Incorporation of CareDx, Inc., filed June 17, 2021.

3.2 Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Registrant, filed June 17, 2021.

8-K 001-36536 3.1 6/21/2021

1 unchanged sentence

8-K 001-36536 3.1 6/20/2023

3.4 Amended and Restated Bylaws of CareDx, Inc., effective as of March 24, 2023.

3.4 Amended and Restated Bylaws of the Registrant, effective as of March 24, 2023.

8-K 001-36536 3.1 3/28/2023

11 unchanged sentences

10-Q 001-36536 4.7 7/29/2021

Description of Securities of CareDx, Inc.

Description of Securities of the Registrant

Form of Change of Control and Severance Agreement between the Registrant and each of its executive officers.

2 unchanged sentences

10-Q 001-36536 10.3 8/14/2022

Promotion Letter, dated July 12, 2021, between the Registrant and Alex Johnson.

8-K 001-36536 10.1 7/20/2021

Form of Indemnification Agreement between the Registrant and each of its directors and executive officers.

17 unchanged sentences

10-Q 001-36536 10.1 11/3/2022

License and Commercialization Agreement, dated May 4, 2018, between the Registrant and Illumina, Inc.

License and Commercialization Agreement, dated May 4, 2018, by and between the Registrant and Illumina, Inc.

10-Q/A 001-36536 10.3 10/9/2018

1 unchanged sentence

8-K 001-36536 1.1 4/15/2022

Separation Agreement, dated September 20, 2023, by and between CareDx, Inc.

and Abraham Ronai.

Separation Agreement, dated September 20, 2023, by and between the Registrant and Abraham Ronai.

001-36536 10.1 11/8/2023

Legal Consulting Agreement, dated September 20, 2023, by and between CareDx, Inc.

and Abraham Ronai.

Legal Consulting Agreement, dated September 20, 2023, by and between the Registrant and Abraham Ronai.

001-36536 10.2 11/8/2023

Consulting Agreement, dated October 30, 2023, by and between CareDx, Inc.

and Reginald Seeto, MBBS.

Separation Agreement, dated November 1, 2023, by and between CareDx, Inc.

and Reginald Seeto, MBSS.

Retention Bonus Letter, dated December 1, 2023, by and between CareDx, Inc.

and Alex Johnson .

Retention Bonus Letter, dated December 1, 2023, by and between CareDx, Inc.

and Abhishek Jain.

Consulting Agreement, dated October 30, 2023, by and between the Registrant and Reginald Seeto, MBBS.

001-36536 10.16 2/28/2024

Separation Agreement, dated November 1, 2023, by and between the Registrant and Reginald Seeto, MBSS.

001-36536 10.17 2/28/2024

Retention Bonus Letter, dated December 1, 2023, by and between the Registrant and Abhishek Jain.

001-36536 10.19 2/28/2024

10.18# Offer Letter, dated March 24, 2024, between the Registrant and John Hanna.

8-K 001-36536 10.1 4/16/2024

10.19# Change of Control and Severance Agreement, dated March 25, 2024, between the Registrant and John Hanna.

8-K 001-36536 10.2 4/16/2024

10.20# Confidential Information, Invention Assignment, Non-Competition, and Arbitration Agreement, dated March 24, 2024, between the Registrant and John Hanna.

8-K 001-36536 10.3 4/16/2024

10.21# CareDx, Inc.

2024 Equity Incentive Plan.

8-K 001-36536 10.1 6/18/2024

10.22# Offer Letter, dated July 27, 2024, between the Registrant and Keith Kennedy.

8-K 001-36536 10.1 9/12/2024

10.23# Change of Control and Severance Agreement, dated July 27, 2024, between the Registrant and Keith Kennedy.

8-K 001-36536 10.2 9/12/2024

10.24# Confidential Information, Invention Assignment, Non-Competition, and Arbitration Agreement, dated July 27, 2024, between the Registrant and Keith Kennedy.

8-K 001-36536 10.3 9/12/2024

10.25# Separation Agreement and Release of Claims, dated September 30, 2024, between the Registrant and Alexander Johnson.

8-K 001-36536 10.1 10/4/2024

10.26# Consulting Agreement, dated September 30, 2024, between the Registrant and Alexander Johnson.

8-K 001-36536 10.2 10/4/2024

10.27# Inducement Restricted Stock Unit Agreement, effective as of September 12, 2024, by and between the Registrant and Keith Kennedy.

10-Q 001-36536 10.4 11/4/2023

10.28# Inducement Stock Option Agreement, effective as of September 12, 2024, by and between the Registrant and Keith Kennedy.

10-Q 001-36536 10.5 11/4/2024

10.29# Offer Letter, dated August 30, 2024, by and between the Registrant and Jessica Meng.

10-Q 001-36536 10.6 11/4/2024

10.30# Change of Control and Severance Agreement, dated August 30, 2024, by and between the Registrant and Jessica Meng.

10-Q 001-36536 10.7 11/4/2024

10.31# Confidential Information, Invention Assignment, Non-Competition, and Arbitration Agreement, dated August 30, 2024, by and between the Registrant and Jessica Meng.

10-Q 001-36536 10.8 11/4/2024

Incorporated by Reference

Description Form File No.

Exhibit Filing Date

10.32# Inducement Restricted Stock Unit Agreement, effective as of September 12, 2024, by and between the Registrant and Jessica Meng.

10-Q 001-36536 10.9 11/4/2024

10.33# Inducement Stock Option Agreement, effective as of September 12, 2024, by and between the Registrant and Jessica Meng.

10-Q 001-36536 10.10 11/4/2024

10.34 Outside Director Compensation Policy, as amended and restated January 6, 2025

8-K 001-36536 10.1 1/8/2025

Insider Trading Policy and Guidelines with Respect to Certain Transactions in Company Securities, dated February 21 , 202 5 .

21.1* Subsidiaries of the Registrant.

3 unchanged sentences

31.2* Principal Financial Officer’s Certifications Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1** Certification Pursuant to 18 U.S.C.

32.1** Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C.

§ 1350 (Section 906 of Sarbanes-Oxley Act of 2002).

Clawback Policy

001-36536 97 2/28/2024

101.INS* Inline XBRL Instance Document

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February 27, 2025

/s/ ALEXANDER L.

President of Patient and Testing Services

President, Chief Executive Officer and Director

(Principal Executive Officer)

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POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Alexander L.

Johnson and Abhishek Jain, and each of them, his true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may do or cause to be done by virtue hereof.

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints John W.

Hanna and Abhishek Jain, and each of them, his true and lawful attorneys-in-fact, each with full power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact or their substitute or substitutes may 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 on the dates and the capacities indicated.

Signature Title Date

/s/ ALEXANDER L.

JOHNSON President of Patient and Testing Services

President, Chief Executive Officer and Director

(Principal Executive Officer)

1 unchanged sentence

/s/ ABHISHEK JAIN Chief Financial Officer

(Principal Financial and Accounting Officer)

(Principal Accounting and Financial Officer)

February 27, 2025

4 unchanged sentences

COHEN Director February 27, 2025

/s/ GRACE COLÓN Director February 28, 2024

/s/ CHRISTINE M.

7 unchanged sentences

Peter Maag, Ph.D.

/s/ BRYAN RIGGSBEE

Director February 27, 2025

Bryan Riggsbee

/s/ ARTHUR TORRES Director February 27, 2025

3 unchanged sentences

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