GRAIL, Inc. 10-K

Item 9A. Controls and Procedures Limitation on Effectiveness of Controls and Procedures In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. 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 judgment in evaluating the benefits of possible controls and procedures relative to their costs. Evaluation of Disclosure Controls and Procedures Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of the end of the period covered by this Annual Report on Form 10‑K, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a‑15(e) and 15d‑15(e) under the Exchange Act). Based on that evaluation, our principal executive officer and principal financial officer concluded that, as of December 31, 2024 , our disclosure controls and procedures were effective at the reasonable assurance level. Management’s Annual Report on Internal Control over Financial Reporting This Annual Report on Form 10-K does not include a report of management’s assessment regarding our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) or an attestation report of our independent registered accounting firm due to a transition period established by rules of the SEC for newly public companies. Additionally, our independent registered accounting firm will not be required to opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 until we are no longer an “emerging growth company” as defined in the JOBS Act. C hanges in Internal Control over Financial Reporting Following the Spin-Off, new corporate and governance functions, such as finance, tax, information technology, human resources, treasury and legal, have been implemented to meet all regulatory requirements for a standalone public company. Apart from the foregoing changes, there were no changes in our internal controls over financial reporting the period for the fourth quarter of December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting. Item 9B. Other (a) Disclosure in lieu of reporting on a Current Report on Form 8-K. None. (b) Insider Trading Arrangements and Policies. During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted , modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement”, as each term is defined in Item 408(a) of Regulation S-K. 131 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections Not applicable . 132 PART III Item 10. Directors, Executive Officers and Corporate Governance Information about our Directors The following table presents information concerning our board of directors. Name Age Position(s) William (Bill) Chase 57 Director Sarah Krevans 66 Director Steve Mizell 65 Director Robert Ragusa 65 Chief Executive Officer and Director Gregory (Greg) Summe 68 Director and Chairperson of the Board The following are brief biographies describing the backgrounds of our directors. William (Bill) Chase has served as a member of our Board since June 2024. Mr. Chase most recently served for 7 years in roles as Executive Vice President, Finance and Administration and Executive Vice President and Chief Financial Officer at AbbVie Inc. (“AbbVie”) from October 2018 until July 2019, where he oversaw all financial, investor, and IT activities and played a critical role in the development of the company’s strategy and licensing and acquisition actions. Prior to AbbVie, Mr. Chase served nearly 25 years in positions of increasing responsibility at Abbott Laboratories, including roles as Corporate Vice President, Licensing & Acquisitions, Corporate Vice President and Treasurer, and Controller, Abbott International. He currently serves as a director and as chair of the audit committee on the boards of each of Intellia Therapeutics, Inc., a publicly-traded biotechnology company, since April 2023, and Parexel International, a privately-held biopharmaceutical services company, since November 2021. Mr. Chase holds a B.S. from the University of Illinois and an M.B.A. from the University of Chicago Booth School of Business. We believe that Mr. Chase is qualified to serve as a member of our board of directors because of his extensive experience in the biotechnology and pharmaceutical industry and his extensive financial and accounting experience. Sarah Krevans has served as a member of our Board since October 21, 2024. Ms. Krevans is the former President and CEO of Sutter Health, a Northern California based not-for-profit, where she served as CEO from 2016 until 2022. She was responsible for Sutter Health’s integrated network of 14,000 clinicians, 24 hospitals, outpatient services, research facilities, and home health and hospice care. Previously, Ms. Krevans served as chief operating officer and president of the Sutter Health Sacramento Sierra Region. She also held executive roles at Kaiser Permanente and served as deputy director of Maine’s Bureau of Medical Services and acting director of Medicaid, health planning and licensure programs. Ms. Krevans has served as a Board Member for The Acacium Group since 2021 and is the Chair for CaringBridge, where she has served as a director since 2022. She has also served on Boards of many not-for-profit organizations and served as Chair of the California Hospital Association in 2022 and as a director from 2016 until 2022. Ms. Krevans earned master’s degrees in business administration and in public health from the University of California, Berkeley, and a bachelor’s degree from Boston University. We believe that Ms. Krevans is qualified to serve as a member of our board of directors because of her experience in U.S. healthcare delivery systems and her extensive industry and leadership experience. Steve Mizell has served as a member of our Board since June 2024. Mr. Mizell is the former Executive Vice President and Chief Human Resources Officer at Merck & Co., Inc., where was employed from October 2018 until his retirement on July 1, 2024. He was responsible for talent acquisition and development, employee health and wellness, total rewards, and human capital management for over 68,000 employees across the world. Mr. Mizell previously served as Executive Vice President & Chief Human Resources Officer at Monsanto Company from 2004 until 2018, where he created an industry-leading workplace for more than 20,000 employees globally. Before that, Mr. Mizell served as Senior Vice President and Chief Corporate Resources Officer for AdvancePCS Inc. and previous to that held several key human resources management roles at companies across the energy, defense, manufacturing, communications and technology sectors. He currently serves on the boards of Allegion Plc., a publicly-traded security products company, since February 2020, and Group 1 Automotive, Inc., a publicly-traded 133 automotive retailer since March 2021, and has earned a Directorship Certification ® from the National Association of Corporate Directors. Mr. Mizell holds a B.S. from Georgia Institute of Technology and an M.S. from Carnegie Mellon University. We believe that Mr. Mizell is qualified to serve as a member of our board of directors because of his extensive experience in risk management, human capital management and leadership. Gregory (Greg) Summe has served as Chair of our Board since June 2024. Mr. Summe is the Founder of investment fund Glen Capital Partners LLC and has served as the Managing Partner since June 2014. Mr. Summe previously served as Managing Director and Vice Chairman of Global Buyout at The Carlyle Group from October 2009 until June 2014. Prior to The Carlyle Group, Mr. Summe served for over a decade as Chairman, CEO, and President of PerkinElmer, Inc., a leading diagnostics and life sciences company. He also served as a Senior Advisor at Goldman Sachs Capital Partners and was the President of AlliedSignal, Inc.’s Automotive, Jet Engine, and General Avionics businesses. Previously, he was the General Manager of General Electric Commercial Motors and a Partner at McKinsey and Company. He currently serves on the boards of NXP Semiconductors N.V., a publicly-traded semiconductor company, since December 2015, State Street Corporation, a publicly-traded financial services company, since 2001, Avantor, Inc., a publicly-traded Life Sciences company, since May 2020, Wheels Up, a publicly traded private aviation company since September 2024 and is a Senior Advisor at Star Mountain Capital, LLC. Mr. Summe previously served on the board of Virgin Orbit Holdings, Inc., a publicly-traded space launch services company, from January 2022 until August 2023, and on the boards of NextGen Acquisition Corp I & II from July 2020 until December 2021. Mr. Summe holds a B.S. from the University of Kentucky, an M.S. from the University of Cincinnati, and an M.B.A. from the Wharton School of the University of Pennsylvania. We believe that Mr. Summe is qualified to serve as a member of our board of directors because of his extensive corporate leadership, industry, and finance experience. The biography of Robert Ragusa is set forth under the section below “—Information about our Executive Officers.” Information about our Executive Officers. The following table presents information concerning our executive officers. Name Age Position(s) Robert Ragusa 65 Chief Executive Officer and Director Aaron Freidin 46 Chief Financial Officer Josh Ofman 60 President The following are brief biographies describing the backgrounds of our executive officers. Robert Ragusa has served as our Chief Executive Officer since October 2021 and as a member of our Board since June 2024. Mr. Ragusa was previously Chief Operations Officer for Illumina from December 2013 until October 2021, where he was responsible for the company’s operations serving clinical and research customers. Prior to joining Illumina, Mr. Ragusa was Executive Vice President of Engineering and Global Operations at Accuray Incorporated from April 2010 until December 2013, a radiation oncology company, where he and his team were responsible for the development, manufacturing and distribution of innovative precision treatment solutions. Mr. Ragusa also previously served as Senior Vice President of Global Operations for Applied Biosystems from 1997 until 2005. Mr. Ragusa currently serves on the Board of Directors for Twist Bioscience Corporation, a publicly-held synthetic biology company, since December 2016. Mr. Ragusa holds a B.S. in electrical engineering and an M.B.A. from the University of Connecticut as well as an M.S. in biomedical and electrical engineering from Carnegie Mellon University. Aaron Freidin has served as our Chief Financial Officer since November 2021 and previously served in various roles at GRAIL since 2016, including Senior Vice President of Finance from January 2021 until November 2021, Vice President of Finance from June 2018 until January 2021, and Corporate Controller from August 2016 until June 2018. Mr. Freidin previously served as VP, Corporate Controller at Counsyl, where he led the Accounting, Reporting, Facilities and Procurement functions. Before this, Mr. Freidin led the SEC Reporting and Revenue functions at Cepheid, and managed multinational and cross-functional client service teams at PricewaterhouseCoopers LLP. Mr. Freidin has over 24 years of finance and accounting experience. Mr. Freidin is 134 a Certified Public Accountant (Inactive) and holds a B.A. in business management from the University of California, Santa Cruz. Josh Ofman , M.D., MSHS, has served as our President since June 2021 and previously served as our Chief Medical Officer from November 2021 until June 2022, as our Chief Medical Officer and Head of External Affairs from June 2020 until August 2021, and as Chief of Corporate Strategy and External Affairs from June 2019 until January 2020. Mr. Ofman has served on the Board of Directors of Cell BT, Inc., a privately-held immunotherapy company focused on the discovery and development of innovative cancer therapeutics, since July 2019. Previously, Mr. Ofman spent more than 15 years at Amgen, where he most recently held the role of Senior Vice President, Global Value, Access and Policy. Prior to that, Mr. Ofman was a faculty member in the Department of Medicine and Health Services Research at University of California, Los Angeles (“UCLA”) School of Medicine, Cedars-Sinai Medical Center, as well as Senior Vice President of Zynx Health Inc. Mr. Ofman holds a B.A. in history and philosophy of science from the University of California, Berkeley, an M.D. from the University of California, Irvine, School of Medicine, and an MSHS from the UCLA School of Public Health. Code of Ethics The Company has adopted a Code of Business Conduct and Ethics that is intended to serve as a code of ethics for purposes of Item 406 of Regulation S-K. Its Code of Business Conduct and Ethics is posted on its website https://investors.grail.com/ and the Company intends to disclose on its website any amendments to, or waivers from, such code to the extent required to be disclosed pursuant to SEC or Nasdaq rules. The remaining information required by this Item will be included in the Company’s definitive proxy statement to be filed with the SEC within 120 days after December 31, 2024, in connection with the solicitation of proxies for the Company’s 2025 Annual Meeting of Shareholders (the “2025 Proxy Statement”), and is incorporated herein by reference. Item 11. Executive Compensation The information required by this Item will be included in the 2025 Proxy Statement, and is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required by this Item will be included in the 2025 Proxy Statement, and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence The information required by this Item will be included in the 2025 Proxy Statement, and is incorporated herein by reference. Item 14. Principal Accountant Fees and Services The information required by this Item will be included in the 2025 Proxy Statement, and is incorporated herein by reference. 135 PART IV Item 15. Exhibits, Financial Statement Schedules (a) Documents filed as part of this report (1) Financial Statements: Consolidated Financial Statements of GRAIL, Inc. are included in Part II, Item 8 of this Annual Report. (2) Financial Statement Schedules : Financial statement schedules are omitted as the required information is either inapplicable or the information is presented in our Consolidated Financial Statements or notes thereto. (3) Exhibits The exhibits listed in the Exhibit Index in (b) below are filed or incorporated by reference as part of this Annual Report. a. Exhibit Index The following documents are filed as exhibits hereto: Exhibit Number Exhibit Description Incorporated by Reference Filed / Furnished Herewith Form File No. Exhibit Filing Date 2.1 Separation and Distribution Agreement, dated June 21, 2024, by and among Illumina, Inc. and GRAIL, Inc. 8-K 001-42045 2.1 6/24/24 3.1 Certificate of Incorporation of GRAIL, Inc., dated June 21, 2024 8-K 001-42045 4.1 6/24/24 3.2 Amended and Restated Bylaws of GRAIL, Inc., Dated June 21, 2024 8-K 001-42045 4.2 6/24/24 3.3 Certificate of Conversion 8-K 001-42045 3.3 6/24/24 4.1 Description of Securities * 10.1 Tax Matters Agreement between GRAIL, LLC and Illumina, Inc. 8-K 001-42045 10.1 6/24/24 10.2 Employee Matters Agreement between GRAIL, LLC and Illumina, Inc. 8-K 001-42045 10.2 6/24/24 10.3 Stockholder and Registration Rights Agreement between GRAIL, LLC and Illumina, Inc. 8-K 001-42045 10.3 6/24/24 10.4 Agreement and Plan of Merger, dated as of September 20, 2020, among Illumina, Inc., SDG Ops, Inc., SDG Ops, LLC and GRAIL, Inc. 10-12B 001-42045 10.4 5/6/24 10.5 Amendment to the Agreement and Plan of Merger, dated as of September 20, 2020, among Illumina, Inc., SDG Ops, Inc., SDG Ops, LLC and GRAIL, Inc., dated as of February 4, 2021 10-12B 001-42045 10.5 5/6/24 10.6† Amended and Restated Supply and Commercialization Agreement, dated as of February 28, 2017, by and between Illumina, Inc. and GRAIL, Inc., as amended on September 27, 2017, August 18, 2021 and on May 18, 2023 10-12B 001-42045 10.6 5/6/24 10.7† Fourth Amendment to the Amended and Restated Supply and Commercialization Agreement by and between Illumina, Inc. and GRAIL, LLC 8-K 001-42045 10.4 6/24/24 10.8# GRAIL, Inc. 2024 Incentive Award Plan 8-K 001-42045 10.1 7/2/24 136 10.9# Form Restricted Stock Unit Agreement 10-12B/A 001-42045 10.9 5/29/24 10.10# Form of Stock Option Agreement 10-12B/A 001-42045 10.1 5/29/24 10.11# Form of Indemnification Agreement between GRAIL, LLC and each of its directors and executive officers 10-12B/A 001-42045 10.11 5/29/24 10.12# GRAIL, Inc. 2024 Employee Stock Purchase Plan 8-K 001-42045 10.2 7/2/24 10.13# Form of Cash-Based Equity Appreciation Award Agreement 10-12B/A 001-42045 10.13 5/29/24 10.14# Employment Offer Letter, between GRAIL, LLC and Robert Ragusa, dated October 14, 2021 10-12B/A 001-42045 10.14 5/29/24 10.15# Letter Agreement, between GRAIL, Inc. and Aaron Freidin, dated July 5, 2018 10-12B/A 001-42045 10.15 5/29/24 10.16# Employment Offer Letter, between GRAIL, Inc. and Josh Ofman, dated May 13, 2019 10-12B/A 001-42045 10.16 5/29/24 10.17† License Agreement by and between The Chinese University of Hong Kong and Cirina Limited (No. TC1510005), dated as of April 7, 2016, as amended May 29, 2017 10-12B/A 001-42045 10.17 5/29/24 10.18† License Agreement by and between The Chinese University of Hong Kong and Cirina Limited (No. TC1510006), dated as of April 7, 2016, as amended May 29, 2017 10-12B/A 001-42045 10.18 5/29/24 10.19† License Agreement by and between The Chinese University of Hong Kong and Cirina Limited (No. TC1711655), dated as of May 29, 2017 10-12B/A 001-42045 10.19 5/29/24 10.20† License Agreement by and between The Chinese University of Hong Kong and Cirina Limited (No. TC1711656), dated as of May 29, 2017 10-12B/A 001-42045 10.2 5/29/24 10.21† License Agreement by and between The Chinese University of Hong Kong and Cirina Limited (No. TC1711657), dated as of May 29, 2017 10-12B/A 001-42045 10.21 5/29/24 10.22 Lease by and between MENLO PREHC I, LLC, MENLO PREPI I, LLC, TPI Investors 9, LLC and GRAIL, Inc., dated as of May 5, 2016 10-12B/A 001-42045 10.22 5/29/24 10.23 First Amendment to Lease among MENLO PREHC I, LLC, MENLO PREPI I, LLC, TPI Investors 9, LLC and GRAIL, Inc., dated as of June 8, 2017 10-12B/A 001-42045 10.23 5/29/24 10.24 Lease Agreement by and between PP Office Owner 1, L.P. and GRAIL, Inc., dated as of June 4, 2020 10-12B/A 001-42045 10.24 5/29/24 10.25# GRAIL, Inc. Non-Employee Director Compensation Program 8-K 001-42045 10.3 7/2/24 19.1 Insider Trading Policy * 21.1 List of subsidiaries of GRAIL, Inc. 10-12B/A 001-42045 21.1 5/6/24 23.1 Consent of Independent Registere d Public Accounting Firm * 31.1 Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. * 31.2 Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. * 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. ** 137 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. ** 97.1 Policy for Recovery of Erroneously Awarded Compensation * 101.INS Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. * 101.SCH Inline XBRL Taxonomy Extension Schema Document * 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document * 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document * 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document * 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document * 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) * * Filed herewith. ** Furnished herewith. # Indicates a management or compensatory plan. † Pursuant to Item 601(b)(10) of Regulation S-K, portions of this exhibit have been omitted as the registrant has determined that the omitted information is (i) not material and (ii) the type of information that the registrant customarily and actually treats as private or confidential. 138 Item 16. Form 10-K Summary None. 139 SIGNATURE 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. GRAIL, Inc. Dated: March 5, 2025 By: /s/ Robert Ragusa Name: Robert Ragusa Title: Chief Executive Officer (Principal Executive Officer) 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 Name Title Date /s/ Robert Ragusa Chief Executive Officer and Director (Principal Executive Officer) March 5, 2025 Robert Ragusa /s/ Aaron Freidin Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) March 5, 2025 Aaron Freidin /s/ William Chase Director March 5, 2025 William Chase /s/ Steven Mizell Director March 5, 2025 Steven Mizell /s/ Sarah Krevans Director March 5, 2025 Sarah Krevans /s/ Gregory Summe Director and Chairperson of the Board March 5, 2025 Gregory Summe 140