GRAIL, Inc. 10-Q

Item 1. Financial Statements GRAIL, Inc. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (amounts in thousands, except share and per share data) March 31, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 133,895 $ 214,234 Short-term marketable securities 540,688 549,236 Accounts receivable, net (1) 19,309 20,312 Supplies (2) 18,716 18,632 Prepaid expenses and other current assets (3) 15,047 17,447 Total current assets 727,655 819,861 Property and equipment, net (4) 64,615 69,061 Operating lease right-of-use assets 62,328 66,373 Restricted cash 3,349 3,349 Intangible assets, net 1,982,306 2,016,890 Other non-current assets 7,352 7,773 Total assets $ 2,847,605 $ 2,983,307 Liabilities and stockholders’/member’s equity Current liabilities: Accounts payable (5) $ 5,769 $ 4,844 Accrued liabilities (6) 53,724 57,241 Operating lease liabilities, current portion 12,973 13,260 Other current liabilities 2,511 1,580 Total current liabilities 74,977 76,925 Operating lease liabilities, net of current portion 51,344 54,881 Deferred tax liability, net 305,192 345,860 Other non-current liabilities 2,424 2,236 Total liabilities 433,937 479,902 Preferred stock, par value of $ 0.001 per share; 50,000,000 shares authorized, no shares issued and outstanding as of March 31, 2025 and December 31, 2024 — — Common stock $ 0.001 par value per share, 1,500,000,000 shares authorized, 35,296,858 shares issued and outstanding as of March 31, 2025, 33,893,409 shares issued and outstanding as of December 31, 2024 35 34 Additional paid-in capital 12,321,510 12,305,250 Accumulated other comprehensive income 1,666 1,451 Accumulated deficit ( 9,909,543 ) ( 9,803,330 ) Total stockholders’/member’s equity 2,413,668 2,503,405 Total liabilities and stockholders’/member's equity $ 2,847,605 $ 2,983,307 (1) Includes related party accounts receivable, net of $ 59 and $ 65 , respectively. (2) Includes related party supplies of $ 742 and $ 3,130 , respectively. (3) Includes related party prepaid expenses and other current assets of $ 70 and $ 77 , respectively. (4) Includes related party property and equipment, net of $ 1,978 and $ 2,227 , respectively. (5) Includes related party accounts payable of $ 5 and $ — , respectively. (6) Includes related party accrued liabilities of $ 75 and $ 104 , respectively. See accompanying notes to condensed consolidated financial statements. 2 Table of Contents GRAIL, Inc. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (amounts in thousands, except share and per share data) Three Months Ended March 31, 2025 March 31, 2024 Revenue: Screening revenue (1) $ 29,133 $ 23,539 Development services revenue 2,704 3,182 Total revenue 31,837 26,721 Costs and operating expenses: Cost of screening revenue (exclusive of amortization of intangible assets) (2) 17,123 13,722 Cost of development services revenue (3) 1,171 1,436 Cost of revenue — amortization of intangible assets 33,472 33,472 Research and development (4) 53,625 101,625 Sales and marketing 34,979 46,819 General and administrative (5) 45,074 57,069 Total costs and operating expenses 185,444 254,143 Loss from operations ( 153,607 ) ( 227,422 ) Other income: Interest income 7,779 2,901 Other income (expense), net ( 584 ) 42 Total other income, net 7,195 2,943 Loss before income taxes ( 146,412 ) ( 224,479 ) Benefit from income taxes 40,199 5,565 Net loss $ ( 106,213 ) $ ( 218,914 ) Net loss per share — Basic and Diluted $ ( 3.10 ) $ ( 7.05 ) Weighted-average shares of common stock used in computing net loss per share: 34,308,435 31,049,148 (1) I ncludes related party screening revenue of $ 77 and $ 129 , respectively. (2 ) I ncludes related party cost of screening revenue of $ 1,511 and $ 2,669 , respectively. (3) Includes related party cost of development services revenue of $ 163 and $ 45 , respectively. (4) Includes related party research and development expenses of $ 1,396 and $ 4,802 , respectively. (5) Includes related party general and administrative expenses of $ — and $ 51 , respectively. See accompanying notes to condensed consolidated financial statements. 3 Table of Contents GRAIL, Inc. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (unaudited) (amounts in thousands) Three Months Ended March 31, 2025 March 31, 2024 Net loss $ ( 106,213 ) $ ( 218,914 ) Other comprehensive income (loss): Change in net unrealized gain on marketable securities ( 250 ) — Foreign currency translation adjustment 465 ( 52 ) Comprehensive loss $ ( 105,998 ) $ ( 218,966 ) See accompanying notes to condensed consolidated financial statements. 4 Table of Contents GRAIL, Inc. CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’/ MEMBER’S EQUITY (unaudited) (amounts in thousands, except share data) Common Stock Shares Amount Additional Paid in Capital Accumulated Other Comprehensive Income Accumulated Deficit Total Stockholders’ Equity Balance as of December 31, 2024 33,893,409 $ 34 $ 12,305,250 $ 1,451 $ ( 9,803,330 ) $ 2,503,405 Net loss — — — — ( 106,213 ) ( 106,213 ) Stock-based compensation expense — — 16,261 — — 16,261 Other comprehensive income — — — 215 — 215 Release of restricted stock units 1,403,449 1 ( 1 ) — — — Balance as of March 31, 2025 35,296,858 $ 35 $ 12,321,510 $ 1,666 $ ( 9,909,543 ) $ 2,413,668 See accompanying notes to condensed consolidated financial statements. Member’s Equity Accumulated Other Comprehensive Income (Loss) Accumulated Deficit Total Member's Equity Balance as of December 31, 2023 $ 11,421,446 $ 1,066 $ ( 7,776,325 ) $ 3,646,187 Net loss — — ( 218,914 ) ( 218,914 ) Stock-based compensation expense 170 — — 170 Other comprehensive loss — ( 52 ) — ( 52 ) Contribution from member, net 312,000 — — 312,000 Balance as of March 31, 2024 $ 11,733,616 $ 1,014 $ ( 7,995,239 ) $ 3,739,391 See accompanying notes to condensed consolidated financial statements. 5 Table of Contents GRAIL, Inc. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (unaudited) (amounts in thousands) Three Months Ended March 31, 2025 March 31, 2024 Cash flows from operating activities Net loss $ ( 106,213 ) $ ( 218,914 ) Adjustments to reconcile net loss to net cash used by operating activities: Amortization of intangibles assets 34,584 34,584 Depreciation 4,695 5,413 Stock-based compensation expense 16,211 29,106 Cash payment for equity awards — ( 42,913 ) Deferred income taxes ( 40,199 ) ( 4,805 ) Amortization of discount on marketable securities ( 6,375 ) — Bad debt expense 273 — Other 484 53 Changes in operating assets and liabilities: Accounts receivable, net (1) 730 1,914 Supplies (2) ( 34 ) 117 Operating lease right-of-use assets and liabilities, net 221 559 Prepaid expenses and other assets (3) 2,821 ( 3,576 ) Accounts payable (4) 895 ( 7,709 ) Accrued and other liabilities (5) ( 3,105 ) ( 1,115 ) Net cash used in operating activities ( 95,012 ) ( 207,286 ) Cash flows from investing activities Purchases of property and equipment ( 62 ) ( 2,548 ) Purchases of marketable securities ( 220,527 ) — Proceeds from maturities of marketable securities 235,200 — Net cash provided by (used in) investing activities 14,611 ( 2,548 ) Cash flows from financing activities Cash funding received from Illumina — 312,000 Net cash provided by financing activities — 312,000 Effect of exchange rate changes on cash, cash equivalents, and restricted cash 62 ( 37 ) Net (decrease) increase in cash, cash equivalents, and restricted cash ( 80,339 ) 102,129 Cash, cash equivalents and restricted cash — beginning of period 217,583 101,512 Cash, cash equivalents and restricted cash — end of period $ 137,244 $ 203,641 Represented by: Cash and cash equivalents $ 133,895 $ 199,723 Restricted cash 3,349 3,918 Total $ 137,244 $ 203,641 Supplemental cash flow information: Property and equipment included in accounts payable and accrued liabilities ( 268 ) ( 593 ) Operating cash flows paid for operating leases, net ( 4,377 ) ( 5,004 ) (1) Includes changes in related party accounts receivable of $ 6 and $ 24 , respectively. (2) Includes changes in related party supplies of $ 2,388 and $( 115 ), respectively. (3) Includes changes in related party prepaid and other current assets of $ 7 and $ — , respectively. (4) Includes changes in related party accounts payable of $ 5 and $ 2,121 , respectively. (5) Includes changes in related party accrued liabilities of $( 29 ) and $ 243 , respectively. See accompanying notes to condensed consolidated financial statements. 6 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) NOTE 1. ORGANIZATION AND DESCRIPTION OF BUSINESS GRAIL, Inc. (“GRAIL” or the “Company”), headquartered in Menlo Park, Californi a , is an innovative commercial-stage healthcare company focused on saving lives and shifting the paradigm of early cancer detection. The Company’s Galleri blood test is a commercially available screening test for early detection of multiple types of cancer. GRAIL’s common stock is listed under the ticker symbol “GRAL” on the Nasdaq Stock Exchange. GRAIL was previously acquired by Illumina, Inc. (”Illumina”) in August 2021, at which point it became a 100 % owned subsidiary of Illumina, and held separate as a part of binding hold separate commitments implemented pursuant to orders issued by the European Commission. GRAIL separated from Illumina on June 24, 2024, as described below. GRAIL was a limited liability company (“LLC”) from August 19, 2021 to June 21, 2024 when it was converted into a corporation (the “Conversion”) in anticipation of such separation. Separation from Illumina On June 24, 2024, (the “Distribution Date”), Illumina completed the previously announced spin-off of GRAIL (the “Spin-Off”). The Spin-Off was completed through a distribution of 85.5 % of the Company’s outstanding common stock to the holders of record of Illumina’s common stock as of the close of business on June 13, 2024 (the “Distribution”), which resulted in the distribution of 31.0 million shares of common stock. As a result of the Distribution, the Company became an independent public entity. Illumina’s ownership of GRAIL reduced to 4,502,126 shares of common stock representing 14.5 % ownership of the Company after the Spin-Off. Unless the context otherwise requires, references to the “Company” or “GRAIL”, refer to (i) GRAIL, LLC prior to the Conversion and (ii) GRAIL, Inc. and its subsidiaries following the Conversion. In co nnection with the Spin-Off, the Company entered into or adopted agreements that provide a framework for the relationship between the Company and Illumina, including, but not limited to the following: • Separation and Distribution Agreement — governed the terms and conditions of the Spin-Off and sets forth aspects of the Company’s and Illumina’s relationship following the Spin-Off. See Note 7 — Legal And Regulatory Proceedings for more information regarding the contingencies related to this agreement. • Tax Matters Agreement — governs the respective rights, responsibilities and obligations of Illumina and the Company after the Spin-Off with respect to all tax matters and includes restrictions to preserve the tax-free status of the Distribution. See Note 10 — Taxes for more information regarding income taxes and Note 7 — Legal And Regulatory Proceedings regarding the contingencies related to this agreement. • Employee Matters Agreement — addressed employment, compensation, and benefits matters, including the allocation and treatment of assets and liabilities relating to employees and compensation and benefits plan s and programs in which GRAIL employees participate, as well as the treatment of cash-based incentive awards in connection with the Spin-Off. • Stockholder and Registration Rights Agreement — governs the respective rights, responsibilities and obligations of Illumina and the Company after the Spin-Off with respect to Illumina’s continuing ownership of GRAIL common stock. • Supply and Commercialization Agreement Amendment — amends the Company’s supply and commercialization agreement with Illumina, which governs the ongoing supply and commercial relationship, including licensing, royalty payments and intellectual property between GRAIL and Illumina. See Note 12 — Related Party Transactions for more information regarding the royalty arrangements with Illumina. Illumina provided the Company with disposal funding (the “Disposal Funding”) in the amount of $ 932.3 million in accordance with the Separation and Distribution Agreement, subject to a clawback feature in the event that the Company (i) consummates a change in control transaction, sells or licenses substantially all of its assets 7 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) or adopts a plan of liquidation (collectively, a “GRAIL Change of Control”), or (ii) (1) pays any dividend on, or makes any other distribution in respect of, any shares of its capital stock or other equity or voting interests (other than a stock dividend or a stock split), or otherwise consummates a return of capital from the Company to any of its equity holders or (2) redeems, purchases or otherwise acquires any of its outstanding shares of capital stock or other equity or voting interests (other than the acquisition of any shares in order to effectuate a “net settlement” transaction for the purposes of satisfying tax withholding obligations arising in connection with the grant, vesting, exercise and/or settlement of any outstanding incentive equity awards of GRAIL held by its current or former employees), in each case, prior to September 24, 2025 (the 15 -month anniversary of the Distribution Date). If the Company consummates a transaction described in the foregoing clause (i), the Company must return to Illumina a cash amount decreasing over time calculated by reference to the number of months which have elapsed since the Distribution Date at the time of the public announcement of the event giving rise to the change of control. If the Company consummates a transaction described in the foregoing clause (ii), the Company must return to Illumina a cash amount equal to the payments made by the Company in connection with such transaction. The amount of clawback payments made cannot exceed the amount of the initial disposal funding. See Note 7 — Legal And Regulatory Proceedings — Contingencies for details. Our Ability to Continue as a Going Concern The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The realization of assets and the satisfaction of liabilities in the normal course of business are dependent on, among other things, the Company’s ability to manage its net loss and to become profitable and operate profitably, to manage the Company’s negative cash flows from operations and to generate positive cash flows from operations, and the Company’s ability to obtain financing to support working capital requirements. The Company had $ 137.2 million of cash, cash equivalents and restricted cash and $ 540.7 million of short-term marketable securities as of March 31, 2025. The Company believes that its existing cash , cash equivalents and short-term marketable securities will be sufficient to meet its working capital and capital expenditure needs for at least the next 12 months, as of the date these condensed consolidated financial statements were filed. NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Principles of Consolidation The accompanying unaudited condensed consolidated financial statements represent the historical operations of the standalone GRAIL legal entity and include purchase accounting adjustments and certain tax adjustments as if the Company filed a separate income tax return and was not included in Illumina’s consolidated return for the period of time the Company was owned by Illumina. All revenues and costs as well as assets and liabilities directly associated with the business activity of the Company are included in the unaudited condensed consolidated financial statements. Certain a ssets and liabilities were reflected at fair value under the new basis of accounting established at the closing of Illumina’s acquisition of the Company in August 2021 (“the Acquisition”). Management considered the need to allocate any historical shared costs incurred by the parent, Illumina, to the accompanying condensed consolidated financial statements. As previously discussed, the European Commission adopted an order requiring Illumina and GRAIL to be held and operated as distinct and separate entities. As no integration ever occurred, management concluded that no material allocations were required. As of March 31, 2024 , the Company had generated net operating loss carryforwards for federal and state tax purposes of $ 4.1 billion and $ 2.6 billion , respectively. As a single member LLC disregarded for tax purposes, these tax attributes are the sole property of Illumina and remained the assets of Illumina following the Spin-off in accordance with the Internal Revenue Code. However, amounts recognized by the Company are not necessarily representative of the amounts that would have been reflected in the financial statements had the Company operated independently of the parent. Related party transactions with Illumina are discussed further in Note 12 — Related Party Transactions . 8 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) These condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. These unaudited condensed consolidated financial statements, reflect all normal recurring adjustments that are necessary to present the results fairly, and include the accounts of the Company and its wholly owned subsidiaries for the interim periods presented. All intercompany balances have been eliminated in consolidation. Significant Accounting Policies During the three months ended March 31, 2025, there were no material changes to the Company’s significant accounting policies disclosed in Note 2 — Summary of Significant Accounting Policies , within the consolidated financial statements for the year ended December 31, 2024 included in its Annual Report on Form 10-K (filed on March 5, 2025). Concentration Risk Significant customers are those that represent more than ten percent of total revenue or accounts receivable, net balances for the periods and as of each condensed consolidated balance sheet date presented, respectively. Revenue from a major customer that amounts to 10% or more of total revenue is as follows: Three Months Ended March 31, 2025 March 31, 2024 Customer A * 10 % *less than 10% Customers that accounted for 10% or more of total accounts receivable balance are as follows: As of March 31, 2025 As of December 31, 2024 Customer A 16 % 32 % Customer B 12 % * *less than 10% Reclassification Certain amounts relating to related party transactions in the condensed consolidated statements of operations and statements of cash flows for the three-month period ended March 31, 2024 have been conformed to the current period presentation of related party transactions. Accounting Pronouncements Not Yet Adopted In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update improves income tax disclosure requirements, primarily through enhanced transparency and decision usefulness of disclosures. This guidance is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted, and can be applied on either a prospective or retroactive basis. The Company is currently evaluating the potential impact of this guidance on its condensed consolidated financial statements and related disclosures. 9 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures. This update intends to improve financial reporting by requiring disclosure of additional information about specific expense categories. This guidance is effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and the guidance is to be applied prospectively and may be applied retrospectively. The Company is currently evaluating the impact of this guidance on our consolidated financial statements and related disclosures. NOTE 3. REVENUE The following table presents the Company’s revenue disaggregated by geographic areas based on the customers’ locations: Three Months Ended (in thousands) March 31, 2025 March 31, 2024 United States Screening $ 28,704 $ 23,539 Development Services 255 165 International (1) Screening 429 — Development Services 2,449 3,017 Total $ 31,837 $ 26,721 _________ (1) International region includes revenue earned from customers located outside of the United States. The following table presents the Company’s revenue disaggregated by revenue source: Three Months Ended (in thousands) March 31, 2025 March 31, 2024 Screening Commercial $ 28,781 $ 23,539 Government (1) $ 352 $ — Development Services Commercial $ 2,704 $ 3,182 Total $ 31,837 $ 26,721 _________ (1) Government screening revenue primarily consists of revenue earned as part of our Galleri-Medicare clinical study. NOTE 4. BALANCE SHEET COMPONENTS The following tables present financial information of certain condensed consolidated balance sheet components: Accounts receivable, net March 31, 2025 December 31, 2024 (in thousands) Trade accounts receivable, gross $ 23,529 $ 24,099 Allowance for credit losses ( 4,220 ) ( 3,787 ) Total accounts receivable, net $ 19,309 $ 20,312 10 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) Accrued liabilities March 31, 2025 December 31, 2024 (in thousands) Accrued compensation expenses $ 20,522 $ 34,530 Accrued clinical studies and research and development expenses 15,361 13,026 Accrued legal and professional service expenses 9,200 2,966 Accrued other expenses 8,641 6,719 Total accrued liabilities $ 53,724 $ 57,241 NOTE 5. FAIR VALUE MEASUREMENTS, CASH EQUIVALENTS AND MARKETABLE SECURITIES The following tables represent the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2025 and December 31, 2024: March 31, 2025 (in thousands) Fair Value Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 131,915 $ 131,915 $ — $ — Total cash equivalents 131,915 131,915 — — U.S. government treasury bills 540,688 540,688 — — Total short-term marketable securities 540,688 540,688 — — Total $ 672,603 $ 672,603 $ — $ — December 31, 2024 (in thousands) Fair Value Level 1 Level 2 Level 3 Financial Assets: Money market funds $ 94,697 $ 94,697 $ — $ — U.S. government treasury bills 117,442 117,442 — — Total cash equivalents 212,139 212,139 — — U.S. government treasury bills 549,236 549,236 — — Total short-term marketable securities 549,236 549,236 — — Total $ 761,375 $ 761,375 $ — $ — The following tables summarize the Company’s cash equivalents and marketable securities’ amortized costs, gross unrealized gains, gross unrealized losses and estimated fair values by significant investment category: March 31, 2025 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Money market funds $ 131,915 $ — $ — $ 131,915 U.S. government treasury bills 540,672 16 — 540,688 Total $ 672,587 $ 16 $ — $ 672,603 11 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) December 31, 2024 (in thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Money market funds $ 94,697 $ — $ — $ 94,697 U.S. government treasury bills 666,412 266 — 666,678 Total $ 761,109 $ 266 $ — $ 761,375 All of the Company’s marketable securities had maturities of less than one year. There were no marketable securities in an unrealized loss position as of March 31, 2025 and December 31, 2024 and none of the Company’s marketable securities had been in an unrealized loss position for more than one year as of March 31, 2025 and December 31, 2024. The Company evaluates investments that are in an unrealized loss position for impairment as a result of credit loss. It was determined that no credit losses exist as of March 31, 2025 and December 31, 2024 because no securities were in an unrealized loss position. NOTE 6. STOCK-BASED COMPENSATION Stock-based compensation expense, which includes expense for both equity and liability-classified awards, reported in the condensed consolidated statements of operations, was as follows: Three Months Ended (in thousands) March 31, 2025 March 31, 2024 Cost of screening revenue (exclusive of amortization of intangible assets) $ 745 $ 470 Cost of development services revenue 17 11 Research and development 4,043 11,443 Sales and marketing 3,045 5,463 General and administrative 8,361 11,719 Stock-based compensation expense, before taxes 16,211 29,106 Related income tax benefits ( 4,394 ) ( 7,068 ) Stock-based compensation expense, net of taxes $ 11,817 $ 22,038 2024 Incentive Award Plan The GRAIL, Inc. 2024 Incentive Award Plan (the “2024 Plan”) was adopted by GRAIL and approved by Illumina, in its capacity as GRAIL’s sole stockholder, in May 2024. The 2024 Plan authorizes the issuance of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalents, performance-based awards, and other stock or cash based awards. The maximum number of shares authorized for issuance under the 2024 Plan increased by 1,694,670 shares to 10,351,487 shares on January 1, 2025 pursuant to the annual automatic evergreen increase provision of the 2024 Plan. As of March 31, 2025, approximately 291,756 shares remained available for future grants under the 2024 Plan. 2024 Inducement Award Plan The GRAIL, Inc. 2024 Inducement Award Plan (the “2024 Inducement Plan”) was adopted by GRAIL’s board of directors on August 9, 2024. The 2024 Inducement Plan is used exclusively for the grant of equity awards to prospective employees who (i) were not previously employees of GRAIL, or (ii) are returning to GRAIL following a bona fide period of non-employment, in any case, in connection with and as an inducement material to such prospective employee’s entering into employment with GRAIL pursuant to Nasdaq Listing Rule 5635(c)(4). This plan authorizes the issuance of stock options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalents, performance-based awards, and other stock or cash based awards. The 2024 Inducement Plan does not have a specified limit on the number of shares authorized for issuance. 12 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) A summary of the Company’s restricted stock unit activity, issued under the 2024 Plan and 2024 Inducement Plan, is as follows: Restricted Stock Units Weighted-Average Grant-Date Fair Value Per Share (Units in thousands) Outstanding at January 1, 2025 5,523 $ 14.22 Awarded 2,139 $ 40.00 Released ( 1,403 ) $ 15.37 Forfeited ( 197 ) $ 17.23 Outstanding at March 31, 2025 6,062 $ 22.69 2024 Employee Stock Purchase Program The GRAIL, Inc. 2024 Employee Stock Purchase Plan (the “ESPP”) was adopted by GRAIL and approved by Illumina’s Board of Directors, in its capacity as GRAIL’s sole stockholder, in May 2024. The maximum number of shares authorized for issuance under the ESPP increased by 338,934 shares to 752,955 shares on January 1, 2025 pursuant to the annual automatic evergreen increase provision of the ESPP. As of March 31, 2025, no shares had been granted under the ESPP plan. Performance-Based Award The Company has one performance-based award outstanding for a former employee for which vesting is based on future revenues. The award has an aggregate potential value of up to $ 78.0 million and expires, to the extent unvested, in August 2030. One-fourth of the total potential value of the award vests immediately upon the achievement of cumulative net revenues in any period of four consecutive fiscal quarters of $ 500.0 million, $ 750.0 million, $ 1.5 billion, and $ 2.0 billion. The Company assesses the probability of achieving the performance conditions associated with the award on a quarterly basis at each reporting period. If and to the extent that the liability becomes due and payable prior to 12:01 a.m. Eastern Time December 24, 2026 (the “Disposal Funding Period”) and paid by GRAIL, in cash, during the Disposal Funding Period, Illumina shall reimburse GRAIL all or such portion of the liability paid by GRAIL in accordance of the terms of the Separation and Distribution Agreement. As of March 31, 2025, it was not probable that the performance conditions associated with the award will be achieved and, therefore, no stock-based compensation expense, or corresponding loss recovery asset or liability, has been recognized in the condensed consolidated financial statements. NOTE 7. LEGAL AND REGULATORY PROCEEDINGS The Company is subject to various claims, complaints, regulatory proceedings, and legal actions that arise from time to time in the ordinary course of business. SEC Inquiry Letter We may also be a party or otherwise involved in new litigation proceedings regarding the Acquisition. For example, in July 2023, Illumina was informed that the staff of the SEC was conducting an investigation relating to Illumina and was requesting documents and communications primarily related to Illumina’s acquisition of GRAIL and certain statements and disclosures concerning GRAIL, our products and the acquisition, and related to the conduct and compensation of certain members of Illumina and GRAIL management, among other things. GRAIL has cooperated with the SEC in this investigation. On May 9, 2025, the Company confirmed with the SEC that the SEC has closed its investigation into this matter. Federal Securities Class Actions 13 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) On November 11, 2023, the first of three securities class action complaints was filed against Illumina and certain of its current and former executive officers in the United States District Court for the Southern District of California. The first-filed case is captioned Kangas v. Illumina, Inc. et al., the second-filed case is captioned Roy v. Illumina, Inc. et al., and the third-filed case is captioned Louisiana Sheriffs’ Pension & Relief Fund v. Illumina, Inc. et al. (collectively, the “Actions”). The complaints generally allege, among other things, that defendants made materially false and misleading statements and omitted material facts relating to Illumina’s acquisition of Grail. The complaints seek unspecified damages, interest, fees, and costs. On January 9, 2024, four movants filed motions to consolidate the Actions and to appoint a lead plaintiff (“Lead Plaintiff Motions”). On April 11, 2024, the Court issued an order consolidating the Actions into a single action (captioned in re Illumina, Inc. Securities Litigation No. 23-cv-2082-LL-MMP), and appointed Universal-Investment-Gesellschaft mbH, UI BVK Kapitalverwaltungsgesellschaft mbH, and ACATIS Investment Kapitalverwaltungsgesellschaft mbH as lead plaintiffs. (the “Lead Plaintiffs”). On June 21, 2024, the Lead Plaintiffs filed a consolidated amended complaint. The amended complaint alleges that GRAIL, in addition to Illumina, and certain of their respective current and former directors and others violated sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b-5 in connection with Illumina's acquisition of GRAIL and disclosures concerning the same. GRAIL has an indemnification obligation for certain current and former directors and officers involved in the matter pursuant to indemnification agreements entered into by these individuals and GRAIL. On September 13, 2024 the plaintiffs further amended the complaint. The Company denies the allegations in the complaints and intends to vigorously defend the litigation. In light of the fact that the lawsuits are in an early stage, the Company cannot predict the ultimate outcome of the suits. Other Legal Matters Legal matters include various claims, complaints, and legal actions that arise from time to time. In addition to direct involvement in legal matters, the Company has entered into indemnification agreements with each of its current and former directors, executive officers, and certain other officers, and has certain indemnification obligations under the Company’s charter and bylaws to these individuals, that provide these directors and officers with indemnification rights that may give rise to liability for the Company even if the Company is not directly named. The Company has indemnification obligations in respect of the Actions and with respect to other legal matters that may arise, or have arisen, from time to time. There can be no assurance that existing or future legal proceedings arising in the ordinary course of business or otherwise will not have a material adverse effect on the Company’s business, financial position, results of operations, or cash flows. The company is involved in various lawsuits and claims arising in the ordinary course of business, including actions with respect to employment matters. In connection with these matters, the Company assesses, on a regular basis, the probability and range of possible loss based on the developments in these matters. A liability is recorded in the condensed consolidated financial statements if it is believed to be probable that a loss has been incurred and the amount of the loss can be reasonably estimated. Since litigation is inherently unpredictable and unfavorable resolutions could occur, assessing contingencies is highly subjective and requires judgments about future events. The Company regularly reviews outstanding legal matters to determine the adequacy of the liabilities accrued and related disclosures. The Company may change its estimates if its assessment of the various factors changes and the amount of ultimate loss may differ from estimates, resulting in a material effect on the Company’s business, financial condition, results of operations, and/or cash flows. As of March 31, 2025, there were no pending litigation with any probable losses that can be reasonably estimated . Contingencies Contingencies primarily correspond to claims arising in the ordinary course of business. If necessary, these contingencies will be accrued, to the extent believed to be reasonably estimable to resolve the matter. The accrued contingency amounts are included in other current liabilities. Should the Company not be able to secure the terms it expects, these estimates may change and will be recognized in the period in which they are identified. In connection with the Spin-Off, Illumina provided the Company with disposal funding in the amount of $ 932.3 million in accordance with the Separation and Distribution Agreement, subject to a clawback feature. The clawback is triggered if, prior to September 24, 2025 (the 15 -month anniversary of the Distribution Date), the 14 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) Company (i) consummates a change in control of the Company or (ii) (1) pays any dividend on, or makes any other distribution in respect of, any shares of its capital stock or other equity or voting interests (other than a stock dividend or a stock split), or otherwise consummates a return of capital from GRAIL to any of its equity holders or (2) redeems, purchases or otherwise acquires any of its outstanding shares of capital stock or other equity or voting interests (other than the acquisition of any shares in order to effectuate a “net settlement” transaction for the purposes of satisfying tax withholding obligations arising in connection with the grant, vesting, exercise and/or settlement of any outstanding incentive equity awards of GRAIL held by its current or former employees). If the Company consummates a transaction described in the foregoing clause (i), the Company must return to Illumina a cash amount decreasing over time calculated by reference to the number of months which have elapsed since the Distribution Date at the time of the public announcement of the event giving rise to the change of control. If the Company consummates a transaction described in the foregoing clause (ii), the Company must return to Illumina a cash amount equal to the payments made by the Company in connection with such transaction. The amount of clawback payments made cannot exceed the amount of the initial disposal funding. As of March 31, 2025 , no contingency liability was recorded as the contingent loss is not probable. On June 21, 2024, in connection with the Spin-Off, Illumina and the Company also entered into the Tax Matters Agreement to govern the respective rights, responsibilities and obligations of Illumina and the Company after the Spin-Off with respect to all tax matters and will include restrictions to preserve the tax-free status of the Distribution. The Tax Matters Agreement included a number of restrictions on the Company to preserve the intended tax treatment of the Spin-Off. Breach of any covenant or representation contained in the Tax Matters Agreement will result in liability to specific separation taxes. As of March 31, 2025 , as it was not probable that the Company will breach the agreement, no contingent liability was recorded in connection with the Tax Matters Agreement. NOTE 8. RESTRUCTURING On August 9 , 2024, following a portfolio review, the Company’s Board of Directors approved a restructuring plan (“Restructuring Plan”) designed to re-prioritize the Company’s resources to focus on its core MCED business and reduce overall spend as the Company progresses towards completion of registrational studies and premarket approval application (“PMA”) submission . The Restructuring Plan was substantially completed in the fourth quarter of 2024, and the Company incurred $ 18.3 million of total restructuring charges from August 9, 2024 through December 31, 2024, consisting primarily of employee severance, benefits, payroll taxes, asset impairments and other associated costs. The following table presents the total restructuring charges by function for the period indicated: Three Months Ended March 31, 2025 (in thousands) Severance and related benefit costs Other Costs Total Research and development $ ( 47 ) $ 111 $ 64 Sales and marketing ( 83 ) — ( 83 ) General and administrative ( 31 ) 16 ( 15 ) Total $ ( 161 ) $ 127 $ ( 34 ) As of March 31, 2025, the Company had no remaining restructuring liability. The following table summarizes the restructuring-related liabilities: (in thousands) Severance and related benefit costs Other Costs Total Amount recorded in accrued liabilities as of December 31, 2024 $ 806 $ 222 $ 1,028 Restructuring charges ( 161 ) 127 ( 34 ) Cash payments made ( 645 ) ( 349 ) ( 994 ) Amount recorded in accrued liabilities as of March 31, 2025 $ — $ — $ — 15 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) NOTE 9. NET LOSS PER SHARE Prior to the completion of the Spin-Off from Illumina, the Company had no common shares issued and outstanding. In connection with the Spin-Off, on June 24, 2024, there were 31.0 million shares of GRAIL common stock distributed to Illumina stockholders. This share amount is utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off. For the three months ended March 31, 2024, these shares are treated as issued and outstanding for purposes of calculating historical earnings per share. The following table presents the calculation of the Company’s basic and diluted net loss per share attributable to common stockholders: Three Months Ended (in thousands, except share and per share data) March 31, 2025 March 31, 2024 Numerator Net loss $ ( 106,213 ) $ ( 218,914 ) Denominator Weighted average shares of common stock—basic and diluted 34,308,435 31,049,148 Net loss per share attributable to common stockholders Basic $ ( 3.10 ) $ ( 7.05 ) Diluted $ ( 3.10 ) $ ( 7.05 ) Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share, as the inclusion of all potential shares of common stock outstanding would have been anti-dilutive. The following common stock equivalents were excluded from the calculation of diluted net loss per share for the periods presented as they had an anti-dilutive effect: Three Months Ended March 31, 2025 March 31, 2024 Unvested restricted stock units 6,053,715 — Shares subject to options to purchase common stock 104,315 104,315 Total 6,158,030 104,315 NOTE 10. TAXES For interim financial statement purposes, U.S. GAAP provision (benefit) for taxes related to ordinary income is determined by applying an estimated annual effective income tax rate against a company’s ordinary income, subject to certain limitations on the benefit of losses. Provision (benefit) for taxes related to items not characterized as ordinary income is recognized as a discrete item when incurred. The estimation of the Company’s income tax provision requires the use of management forecasts and other estimates, application of statutory income tax rates, and an evaluation of valuation allowances. The Company’s estimated annual effective income tax rate may be revised, if necessary, in each interim period. The worldwide effective income tax rates for the three months ended March 31, 2025 and March 31, 2024 were 27.41 % and 2.50 %, respectively. The increase for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 primarily relates to the Company’s 2024 valuation allowance impacts against pre-tax losses prior to the Spin-off. The effective tax rate was higher than the 21% U.S. federal statutory rate for the three months ended March 31, 2025, primarily due to state taxes, offset by discrete tax benefits from stock-based compensation. 16 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. This evaluation is based on factors including, but not limited to, changes in facts or circumstances, changes in tax law, effectively settled issues under audit, and new audit activity. Interest and penalties related to unrecognized tax benefits are included within income tax expense. For the three months ended March 31, 2025, the Company recorded income tax expense related to its Federal and California R&D Credits of $ 0.2 million and $ 0.1 million, respectively. The Company files income tax returns in the U.S. federal jurisdiction and various states. As of the date of this filing, the Company is not currently under examination by income tax authorities in federal, state, or other jurisdictions. All tax returns will remain open for examination by the federal and state authorities for three and four years, respectively, from the date of utilization of any net operating loss or credits. As discussed in Note 1 — Organization And Description Of Business and Note 2 — Summary Of Significant Accounting Policies — Basis of Presentation , prior to the Spin-Off, for tax purposes, the Company operated as a subsidiary of Illumina and not as a separately regarded taxable entity. Accordingly, the effective worldwide income tax rate for the three months ended March 31, 2024 was calculated using the separate return method as if the Company filed income tax returns on both a standalone basis and on a carve-out basis. NOTE 11. SEGMENT INFORMATION The Company operates and manages its business as one reportable operating segment which provides multi-cancer early detection testing and services. The Company's chief operating decision maker (“CODM”) is the chief executive officer. The chief operating decision maker reviews financial information on an aggregate basis for the purposes of evaluating financial performance and allocating resources based on net income (loss), adjusted gross margin and adjusted EBITDA. Net income (loss) is the measure of segment profit most consistent with U.S. GAAP that is regularly reviewed by the CODM to allocate resources and assess performance. The CODM does not evaluate operating segment performance using asset information. The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s single reporting segment. A reconciliation to the consolidated net loss for the three months ended March 31, 2025 and March 31, 2024 is included in the table below: 17 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) Three Months Ended (in thousands) March 31, 2025 March 31, 2024 Revenue: Screening revenue $ 29,133 $ 23,539 Development services revenue 2,704 3,182 Total revenue 31,837 26,721 Costs and operating expenses: Cost of screening revenue (exclusive of amortization of intangible assets) (1) 17,123 13,722 Cost of development services revenue (1) 1,171 1,436 Compensation 63,517 89,621 Depreciation and intangible assets amortization expense 39,279 39,996 Stock-based compensation 15,450 28,625 Professional services 9,195 15,484 Cloud computing and information technology 7,390 8,374 Clinical studies 5,922 14,905 Laboratory supplies and research collaborations 4,529 17,411 Facilities 2,520 4,752 Other segment expenses (2) 19,348 19,817 Total costs and operating expenses 185,444 254,143 Loss from Operations ( 153,607 ) ( 227,422 ) Other income (expense): Interest income 7,779 2,901 Other income (expense), net ( 584 ) 42 Benefit from income taxes 40,199 5,565 Net Loss $ ( 106,213 ) $ ( 218,914 ) (1) Cost of screening revenue (exclusive of amortization of intangible assets) and cost of development services revenue include stock-based compensation expense. See Note 6 — Stock-Based Compensation for further details. (2) Other segment expenses primarily includes costs related to contractors and temporary labor, marketing expenses, legal expenses, and bad debt expense NOTE 12. RELATED PARTY TRANSACTIONS Illumina Purchases and Sales The Company was a subsidiary of Illumina, Inc. between August 19, 2021 to June 23, 2024. Subsequent to the Spin-Off, Illumina retained a 14.5 % stake in the Company. As of March 31, 2025, Illumina held 4,502,126 shares of common stock representing a 12.8 % stake in the Company. Illumina is both a customer of the Company and a major supplier of the Company’s reagents and capital equipment. Goods and services transactions with Illumina are invoiced and paid when due. 18 Table of Contents GRAIL, Inc. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) Goods and services transactions with Illumina have been reflected in the condensed consolidated financial statements as follows: (in thousands) March 31, 2025 December 31, 2024 Accounts receivable $ 59 $ 65 Supplies 742 3,130 Prepaid expenses and other current assets 70 77 Property and equipment, net 1,978 2,227 Accounts payable 5 — Accrued liabilities 75 104 Three Months Ended (in thousands) March 31, 2025 March 31, 2024 Screening revenue $ 77 $ 129 Cost of screening revenue 1,511 2,669 Cost of development services revenue 163 45 Operating expenses—Research and development 1,396 4,802 Operating expenses—General and administrative — 51 In June 2024, the Company entered into an amendment to its Supply and Commercialization Agreement with Illumina. Under the terms of the amended agreement, regardless of whether its products incorporate any Illumina technology, the Company has agreed to pay to Illumina a high single-digit royalty, subject to certain reductions, in perpetuity on net sales generated by its products or revenues otherwise generated or received by the Company, subject to certain exceptions, in the field of oncology. Per the terms of the Separation and Distribution Agreement with Illumina, the royalty arrangement is suspended until the earlier of December 24, 2026 or any earlier change of control of the Company, at which time a high-single digit royalty payments will be payable. Contributions from Member, Net The following related party transactions between the Company and Illumina have been included in these condensed consolidated financial statements. As there was no intercompany loan agreement between Illumina and GRAIL and because these transactions had no history of being settled and were not settled per the terms of the Separation and Distribution Agreement, the total net effect of these transactions are reflected in the condensed consolidated statements of cash flows as cash provided by financing activities and in the condensed consolidated balance sheets as contribution from member, net, in member’s equity. The following table presents the components of the net transfers to and from Illumina prior to the Spin-Off: Three Months Ended (in thousands) March 31, 2024 Cash funding received from Illumina $ 312,000 Total contribution from member, net $ 312,000 19