2 unchanged sentences
(amounts in thousands, except share and per share data)
+Added: September 30,
2025 December 31,
15 unchanged sentences
Total assets $ 2,601,031 $ 2,983,307
−Removed: Liabilities and stockholders’/member’s equity
+Added: Liabilities and stockholders’ equity
Current liabilities:
11 unchanged sentences
Preferred stock, par value of $ 0.001 per share;
−Removed: 50,000,000 shares authorized, no shares issued and outstanding as of June 30, 2025 and December 31, 2024
−Removed: Common stock $ 0.001 par value per share, 1,500,000,000 shares authorized, 36,047,799 shares issued and outstanding as of June 30, 2025, 33,893,409 shares issued and outstanding as of December 31, 2024
+Added: 50,000,000 shares authorized, no shares issued and outstanding as of September 30, 2025 and December 31, 2024
+Added: Common stock $ 0.001 par value per share, 1,500,000,000 shares authorized, 36,160,998 shares issued and outstanding as of September 30, 2025, 33,893,409 shares issued and outstanding as of December 31, 2024
Additional paid-in capital 12,349,976 12,305,250
1 unchanged sentence
Accumulated deficit ( 10,112,505 ) ( 9,803,330 )
−Removed: Total stockholders’/member’s equity 2,314,643 2,503,405
−Removed: Total liabilities and stockholders’/member's equity $ 2,702,551 $ 2,983,307
+Added: Total stockholders' equity 2,239,963 2,503,405
+Added: Total liabilities and stockholders’ equity $ 2,601,031 $ 2,983,307
(1) Includes related party accounts receivable, net of $ 34 and $ 65 , respectively.
7 unchanged sentences
(amounts in thousands, except share and per share data)
−Removed: Three Months Ended Six Months Ended
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: Three Months Ended Nine Months Ended
+Added: September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
Screening revenue (1)
26 unchanged sentences
36,124,256 31,880,054 35,415,266 31,326,117
−Removed: (1) I ncludes related party screening revenue of $ 52 and $ 129 for the three and six months ended June 30, 2025 and $ 108 and $ 237 for the three and six months ended June 30, 2024, respectively.
−Removed: (2) I ncludes related party cost of screening revenue of $ 1,176 and $ 2,687 for the three and six months ended June 30, 2025 and $ 3,457 and $ 6,126 for the three and six months ended June 30, 2024, respectively.
−Removed: (3) Includes related party cost of development services revenue of $ 19 and $ 182 for the three and six months ended June 30, 2025 and $ 71 and $ 116 for the three and six months ended June 30, 2024, respectively.
−Removed: (4) Includes related party research and development expenses of $ 578 and $ 1,974 for the three and six months ended June 30, 2025 and $ 5,310 and $ 10,112 for the three and six months ended June 30, 2024, respectively.
−Removed: (5) Includes related party general and administrative expenses of $ — and $ — for the three and six months ended June 30, 2025 and $ 52 and $ 103 for the three and six months ended June 30, 2024, respectively.
−Removed: See accompanying notes to unaudited condensed consolidated financia l statements.
+Added: (1) I ncludes related party screening revenue of $ 50 and $ 179 for the three and nine months ended September 30, 2025 and $ 129 and $ 366 for the three and nine months ended September 30, 2024, respectively.
+Added: (2) I ncludes related party cost of screening revenue of $ 1,237 and $ 3,924 for the three and nine months ended September 30, 2025 and $ 3,658 and $ 9,784 for the three and nine months ended September 30, 2024, respectively.
+Added: (3) Includes related party cost of development services revenue of $ 78 and $ 260 for the three and nine months ended September 30, 2025 and $ 143 and $ 259 for the three and nine months ended September 30, 2024, respectively.
+Added: (4) Includes related party research and development expenses of $ 973 and $ 2,947 for the three and nine months ended September 30, 2025 and $ 6,588 and $ 16,700 for the three and nine months ended September 30, 2024, respectively.
+Added: (5) Includes related party general and administrative expenses of nil for the three and nine months ended September 30, 2025 and $ 1 and $ 104 for the three and nine months ended September 30, 2024, respectively.
+Added: See accompanying notes to unaudited condensed consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(amounts in thousands)
−Removed: Three Months Ended Six Months Ended
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: Three Months Ended Nine Months Ended
+Added: September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
Net loss $ ( 88,977 ) $ ( 125,688 ) $ ( 309,175 ) $ ( 1,929,939 )
Other comprehensive income (loss):
−Removed: Change in net unrealized gain on marketable securities ( 59 ) — ( 309 ) —
+Added: Change in net unrealized gain (loss) on marketable securities 172 — ( 137 ) —
Foreign currency translation adjustment ( 19 ) 800 1,142 1,120
1 unchanged sentence
See accompanying notes to unaudited condensed consolidated financial statements.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’/ MEMBER’S EQUITY
+Added: CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(amounts in thousands, except share data)
14 unchanged sentences
Balance as of June 30, 2025 36,047,799 $ 36 $ 12,335,832 $ 2,303 $ ( 10,023,528 ) $ 2,314,643
+Added: Net loss — — — — ( 88,977 ) ( 88,977 )
+Added: Stock-based compensation expense — — 14,144 — — 14,144
+Added: Other comprehensive income — — — 153 — 153
+Added: Release of restricted stock units 113,199 — — — — —
+Added: Balance as of September 30, 2025 36,160,998 $ 36 $ 12,349,976 $ 2,456 $ ( 10,112,505 ) $ 2,239,963
See accompanying notes to unaudited condensed consolidated financial statements.
20 unchanged sentences
Balance as of June 30, 2024 31,049,148 $ 31 $ — $ 12,274,286 $ 1,386 $ ( 9,580,576 ) $ 2,695,127
+Added: Net loss — — — — — ( 125,688 ) ( 125,688 )
+Added: Stock-based compensation expense — — — 17,397 — — 17,397
+Added: Other comprehensive income — — — — 800 — 800
+Added: Release of restricted stock units 2,154,596 2 — ( 2 ) — — —
+Added: Balance as of September 30, 2024 33,203,744 $ 33 $ — $ 12,291,681 $ 2,186 $ ( 9,706,264 ) $ 2,587,636
See accompanying notes to unaudited condensed consolidated financial statements.
2 unchanged sentences
(amounts in thousands)
−Removed: Six Months Ended
−Removed: 2025 June 30,
+Added: Nine Months Ended
+Added: September 30,
+Added: 2025 September 30,
Cash flows from operating activities
12 unchanged sentences
Accounts receivable, net (1)
−Removed: ( 902 ) ( 3,811 )
Operating lease right-of-use assets and liabilities, net 761 1,545
4 unchanged sentences
Accrued and other liabilities (5)
−Removed: ( 8,480 ) ( 14,283 )
Net cash used in operating activities ( 235,222 ) ( 483,666 )
48 unchanged sentences
• 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.
−Removed: • 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.
+Added: • Supply and Commercialization Agreement Amendment — amended 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 14 — Related Party Transactions for more information regarding the royalty arrangements with Illumina.
−Removed: 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
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: that the Company (i) consummates a change in control transaction, sells or licenses substantially all of its assets 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).
−Removed: 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.
−Removed: 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.
−Removed: The amount of clawback payments made cannot exceed the amount of the initial disposal funding.
+Added: 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, which was subject to a clawback feature that lapsed on September 24, 2025.
See Note 9 — Legal And Regulatory Proceedings — Contingencies for details.
2 unchanged sentences
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.
−Removed: The Company had $ 130.8 million of cash, cash equivalents and restricted cash and $ 475.3 million of short-term marketable securities as of June 30, 2025.
+Added: The Company had $ 126.9 million of cash and cash equivalents and $ 413.2 million of short-term marketable securities as of September 30, 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 unaudited condensed consolidated financial statements were filed.
3 unchanged sentences
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.
−Removed: 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”).
+Added: Certain a ssets and liabilities were reflected at fair value under the new basis of accounting established at the closing of the Acquisition.
Management considered the need to allocate any historical shared costs incurred by the parent, Illumina, to the accompanying unaudited condensed consolidated financial statements.
2 unchanged sentences
Prior to the Spin-Off, the Company had generated net operating loss carryforwards for federal and state tax purposes, however, 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.
−Removed: 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
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: 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 14 — Related Party Transactions .
These unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S.
−Removed: for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”).
+Added: for interim financial information and pursuant to this Quarterly Report on Form 10-Q (“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.
3 unchanged sentences
The results for the interim periods presented are not necessarily indicative of the results expected for any future period.
−Removed: The following information should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s 2024 Form 10-K.
+Added: The following information should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 2024 Form 10-K.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Significant Accounting Policies
−Removed: During the six months ended June 30, 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 2024 Form 10-K, except as described below.
+Added: During the nine months ended September 30, 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 2024 Form 10-K, except as described below.
+Added: Leases are classified as operating or financing at lease inception and as necessary at modification.
+Added: Leased assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease.
+Added: Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the consolidated balance sheets.
+Added: Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term.
+Added: When readily determinable, the Company uses the rate implicit in the lease to discount lease payments;
+Added: however, when the rate is not readily determinable, the Company uses the incremental borrowing rate based on the information available at the commencement date.
+Added: The incremental borrowing rate is the rate of interest that a company would have to pay to borrow an amount equal to the lease payments on a collateralized basis over a similar term and in a similar economic environment.
+Added: The operating lease ROU asset also includes any initial direct costs, lease payments made prior to lease commencement, and lease incentives received.
+Added: Variable lease payments are expensed as incurred and are not included within the ROU asset and lease liability calculation.
+Added: Variable lease payments primarily include reimbursements of costs incurred by lessors for common area maintenance and utilities.
+Added: For each lease, the determined lease term is based on a noncancellable period, including any rent-free periods provided by the lessor, and may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.
+Added: Lease cost for lease payments is recognized on a straight-line basis over the lease term.
+Added: Certain lease agreements contain lease and non-lease components.
+Added: The Company accounts for non-lease components as part of the lease component to which they relate.
+Added: The Company does not recognize ROU assets and lease liabilities for short-term leases, which have a lease term of twelve months or less and do not include an option to purchase the underlying asset that the Company is reasonably certain to exercise.
Intangible Assets
−Removed: Intangible assets identified in the Acquisition include GRAIL trade names, developed technology, and GRAIL in-process research and development (“IPR&D”) and were measured at fair value as of the closing date of Illumina’s acquisition of GRAIL (“Closing Date”).
+Added: Intangible assets identified in the Acquisition include GRAIL trade names, developed technology, and GRAIL in-process research and development (“IPR&D”) and were measured at fair value as of the Closing Date.
The Company’s trade names, GRAIL and Galler i , have brand recognition in the market related to the services GRAIL provides customers and the research and development activities GRAIL performs.
4 unchanged sentences
IPR&D is considered indefinit e -lived and therefore is not amortized until completed and placed into service, at which point it will begin to be amortized over its estimated useful life or expensed upon abandonment of the associated research and development efforts.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
While IPR&D is not amortize d , it is reviewed for impairment at least annually, or more frequently if events or circumstances indicate a potential for impairment.
5 unchanged sentences
The Company may elect to bypass the qualitative assessment in a period and proceed to perform the quantitative indefinite-lived intangible asset impairment test.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Stock- Based Compensation Expense - 2024 Employee Stock Purchase Plan
7 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: Nine Months Ended
+Added: September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
* 10 % * 10 %
1 unchanged sentence
Customers that accounted for 10% or more of total accounts receivable balance are as follows:
+Added: September 30,
2025 December 31, 2024
1 unchanged sentence
Reclassification
−Removed: Certain amounts relating to related party transactions in the unaudited condensed consolidated statements of operations and statements of cash flows for the respective periods ended June 30, 2024 have been conformed to the current period presentation of related party transactions.
+Added: Certain amounts relating to related party transactions in the unaudited condensed consolidated statements of operations and statements of cash flows for the respective periods ended September 30, 2024 have been conformed to the current period presentation of related party transactions.
Accounting Pronouncements Not Yet Adopted
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In December 2023, the FASB issued ASU No.
3 unchanged sentences
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.
−Removed: The Company is currently evaluating the potential impact of this guidance on its condensed consolidated financial statements and related disclosures.
+Added: The Company is currently compiling the information required for these disclosures and expects to provide the required disclosures in the year ending December 31, 2025.
In November 2024, the FASB issued ASU No.
4 unchanged sentences
The Company is currently evaluating the impact of this guidance on its consolidated financial statements and related disclosures.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: In July 2025, the FASB issued ASU No.
+Added: 2025-05, Financial Instruments—Credit Losses (Topic 326):
+Added: Measurement of Credit Losses for Accounts Receivable and Contract Assets.
+Added: This update provides entities with a practical expedient related to developing reasonable and supportable forecasts as part of estimating expected credit losses, in which entities may elect to assume that current conditions as of the balance sheet date do not change for the remaining life of the asset.
+Added: This guidance is effective for fiscal years beginning after December 15, 2025 and interim reporting periods within those annual reporting periods.
+Added: Early adoption is permitted.
+Added: The Company is currently evaluating the impact of this guidance on its consolidated financial statements and related disclosures.
+Added: In September 2025, the FASB issued ASU No.
+Added: 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):
+Added: Targeted Improvements to the Accounting for Internal-Use Software.
+Added: This update removes all references to software development project stages and requires entities to start capitalizing software costs when both of the following occur:
+Added: (i) management has authorized and committed to funding the software project and (ii) it is probable that the project will be completed and the software will be used to perform the function intended.
+Added: This guidance is effective for fiscal years beginning after December 15, 2027 and interim reporting periods within those annual reporting periods.
+Added: Early adoption is permitted.
+Added: The transition method may be prospective, modified, or retrospective.
+Added: The Company is currently evaluating the impact of this guidance on its consolidated financial statements and related disclosures.
The following table presents the Company’s revenue disaggregated by geographic areas based on the customers’ locations:
−Removed: Three Months Ended Six Months Ended
−Removed: (in thousands) June 30,
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: Three Months Ended Nine Months Ended
+Added: (in thousands) September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
United States
−Removed: $ 34,208 $ 28,163 $ 62,912 $ 51,702
+Added: Screening $ 32,570 $ 25,374 $ 95,482 $ 77,076
Development Services 78 484 332 1,149
−Removed: — 500 255 665
International (1)
+Added: Screening 237 — 837 —
Development Services 3,309 2,794 6,924 9,118
−Removed: 1,165 3,307 3,614 6,324
−Removed: $ 35,544 $ 31,970 $ 67,381 $ 58,691
+Added: Total $ 36,194 $ 28,652 $ 103,575 $ 87,343
(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:
−Removed: Three Months Ended Six Months Ended
−Removed: (in thousands) June 30,
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
−Removed: $ 33,472 $ 28,163 $ 62,253 $ 51,702
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Three Months Ended Nine Months Ended
+Added: (in thousands) September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
+Added: Commercial $ 31,428 $ 25,333 $ 93,681 $ 77,035
Government (1)
1 unchanged sentence
Development Services
−Removed: $ 1,165 $ 3,807 $ 3,869 $ 6,989
−Removed: $ 35,544 $ 31,970 $ 67,381 $ 58,691
+Added: Commercial 3,387 3,278 7,256 10,267
+Added: Total $ 36,194 $ 28,652 $ 103,575 $ 87,343
(1) Government screening revenue primarily consists of revenue earned as part of the Company’s Galleri-Medicare clinical study.
8 unchanged sentences
These estimates and assumptions represent a Level 3 measurement because they include unobservable inputs that are supported by little or no market activity and reflect Company-determined and judgmental factors for these assumptions in measuring fair value.
−Removed: The assumptions in the assessment of an impairment analysis are inherently subjective due to uncertainty and any
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: slight changes in these rates and assumptions could have a significant impact on the concluded value of goodwill.
+Added: The assumptions in the assessment of an impairment analysis are inherently subjective due to uncertainty and any slight changes in these rates and assumptions could have a significant impact on the concluded value of goodwill.
The Company recognized a goodwill impairment of $ 888.9 million as a result of the impairment assessment, primarily due to changes to the forecast of GRAIL’s value and the method for valuing GRAIL .
Intangible Assets
−Removed: Intangible assets identified in the Acquisition include trade names, developed technology, and IPR&D and were measured at fair value as of the closing date of Illumina’s acquisition of the Company ( “Closing Date”) .
+Added: Intangible assets identified in the Acquisition include developed technology, trade names and IPR&D and were measured at fair value as of the closing date of Illumina’s acquisition of the Company ( “Closing Date”) .
The following roll-forward indicates the fair values assigned to finite-lived intangible assets from the Acquisition and the resulting amortization:
−Removed: June 30, 2025 December 31, 2024
+Added: September 30, 2025 December 31, 2024
(in thousands) Gross Carrying Amount Accumulated Amortization Net Intangible Assets Gross Carrying Amount Accumulated Amortization Net Intangible Assets
2 unchanged sentences
Total Finite-Lived Intangible Assets $ 2,450,000 $ ( 564,860 ) $ 1,885,140 $ 2,450,000 $ ( 461,110 ) $ 1,988,890
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The following roll-forward indicates the carrying value of the indefinite-lived intangible asset from the Acquisition and the impairment expenses recorded:
1 unchanged sentence
Balance as of January 1, 2024 $ 560,000
+Added: Impairment ( 532,000 )
Balance as of December 31, 2024
−Removed: Balance as of June 30, 2025
+Added: Impairment ( 28,000 )
+Added: Balance as of September 30, 2025
In conjunction with Illumina’s Q2 2024 goodwill impairment assessment, the IPR&D intangible asset of the GRAIL reporting unit was evaluated for potential impairment by Illumina prior to the Spin-Off.
1 unchanged sentence
Estimates and assumptions used in the income approach included projected cash flows and a discount rate.
−Removed: The discount rate selected at the time of the IPR&D intangible impairment assessment was 46.5 %.
+Added: The discount rate selected at the time of the IPR&D intangible impairment assessment prior to the Spin-Off was 46.5 %.
Based on the impairment test performed, Illumina assessed and determined that the carrying value of GRAIL’s IPR&D intangible asset exceeded its estimated fair value.
As a result of push down accounting, the Company recognized an impairment of $ 420.0 million primarily due to changes to revenue projections and the discount rate utilized.
−Removed: Subsequent to the Spin-Off, the Company performed a portfolio review and determined to decrease investment in the development of the IPR&D asset, which impacted the amount and timing of expected future cash flows attributable to IPR&D.
+Added: In Q2 2024, subsequent to the Spin-Off, the Company performed a portfolio review and determined to decrease investment in the development of the IPR&D asset, which impacted the amount and timing of expected future cash flows attributable to IPR&D.
This determination was driven by the impact of the Company’s post-Spin-Off capital structure, constitution of the Company’s Board at the time of the Spin-Off as the key decision maker for the determination, and increased ability to revisit the Company’s business strategy and portfolio as a standalone public company without regulatory oversight.
4 unchanged sentences
As a result, the Company recognized an additional impairment of $ 112.0 million , primarily due to a decrease in projected cash flows.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In Q2 2025, the Company identified a change in market conditions in relation to its IPR&D asset which is in development.
7 unchanged sentences
The assumptions in the assessment of an impairment analysis are inherently subjective due to uncertainty and any slight changes in these rates and assumptions could have a significant impact on the concluded value of the IPR&D intangible asset.
−Removed: The IPR&D intangible asset is not currently subject to amortization.
−Removed: Amortization expense related to finite-lived intangible assets was $ 34.6 million for the three month periods ended June 30, 2025 and 2024 and $ 69.2 million for the six month periods ended June 30, 2025 and 2024.
+Added: Amortization expense related to finite-lived intangible assets was $ 34.6 million for each of the three month periods ended September 30, 2025 and 2024 and $ 103.8 million for each of the nine month periods ended September 30, 2025 and 2024 .
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The estimated future annual amortization of finite-lived intangible assets is shown in the following table.
6 unchanged sentences
The following tables present financial information of certain condensed consolidated balance sheet components:
−Removed: Accounts receivable, net June 30,
+Added: Accounts receivable, net September 30,
2025 December 31,
3 unchanged sentences
Total accounts receivable, net $ 16,282 $ 20,312
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: Accrued liabilities June 30,
+Added: Accrued liabilities September 30,
2025 December 31,
6 unchanged sentences
Total accrued liabilities $ 58,076 $ 57,241
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FAIR VALUE MEASUREMENTS, CASH EQUIVALENTS AND MARKETABLE SECURITIES
−Removed: The following tables represent the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2025 and December 31, 2024:
−Removed: June 30, 2025
+Added: The following tables represent the fair value hierarchy for the Company’s financial assets measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024:
+Added: September 30, 2025
(in thousands) Fair Value
24 unchanged sentences
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:
−Removed: June 30, 2025
+Added: September 30, 2025
(in thousands) Amortized Cost
7 unchanged sentences
$ 538,044 $ 130 $ — $ 538,174
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2024
9 unchanged sentences
All of the Company’s marketable securities had maturities of less than one year.
−Removed: The Company had 7 securities with a fair value of $ 291.7 million in an unrealized loss position as of June 30, 2025 and no securities in unrealized loss position as of December 31, 2024.
−Removed: None of the Company’s marketable securities had been in an unrealized loss position for more than one year as of June 30, 2025 and December 31, 2024.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: The Company had one security with a fair value of $ 18.3 million in an unrealized loss position as of September 30, 2025 and no securities in unrealized loss position as of December 31, 2024.
+Added: None of the Company’s marketable securities had been in an unrealized loss position for more than one year as of September 30, 2025 and December 31, 2024.
The Company evaluates investments that are in an unrealized loss position for impairment as a result of credit loss.
−Removed: It was determined that no credit losses exist as of June 30, 2025 and December 31, 2024 because the change in market value for those securities that were in an unrealized loss position resulted from fluctuating interest rates rather than a deterioration of the credit worthiness of the issuers.
+Added: It was determined that no credit losses exist as of September 30, 2025 because the change in market value for the security that was in an unrealized loss position resulted from fluctuating interest rates rather than a deterioration of the credit worthiness of the issuers.
The Company does not intend to sell the money market funds and short term investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost basis.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: The Company has entered into operating leases for facilities and equipment used for research and development.
+Added: Operating leases have remaining lease terms which range from approximately 1 to 8 years, and often include one or more options to renew.
+Added: These renewal terms can extend the lease term from 5 to 15 years and are included in the lease term when it is reasonably certain that the option will be exercised.
+Added: The exercise of lease renewal and termination options are at the sole discretion of the Company.
+Added: The Company also has variable lease payments that are primarily comprised of common area maintenance and utility charges.
+Added: The Company’s weighted average remaining lease term was approximately 7.0 years and 7.3 years as of September 30, 2025 and December 31, 2024, respectively.
+Added: The Company’s weighted average discount rate for operating leases was 2.6 % and 2.5 % as of September 30, 2025, and December 31, 2024, respectively.
+Added: The components of lease costs are as follows:
+Added: Three Months Ended Nine Months Ended
+Added: (in thousands) September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
+Added: Operating lease costs $ 4,427 $ 4,563 $ 13,338 $ 14,436
+Added: Variable lease costs 1,003 1,124 3,058 3,618
+Added: Total lease costs $ 5,430 $ 5,687 $ 16,396 $ 18,054
+Added: Future undiscounted lease payments under operating leases as of September 30, 2025 were as follows:
+Added: (in thousands) Amount
+Added: Remainder of 2025
+Added: 2030 and thereafter
+Added: Total undiscounted lease payments
+Added: Imputed interest
+Added: Tenant improvement allowance*
+Added: Total operating lease liabilities
+Added: * Tenant improvement allowance is estimated to be received as follows:
+Added: approximately $ 0.4 million in the next twelve months and $ 9.3 million thereafter.
+Added: Excluded from the lease obligation table above is a commercial lease agreement (the “Lease”) entered into by and between the Company and Sunnyvale Office Acquisition, LLC, as of September 11, 2025, pursuant to which the Company agreed to lease an aggregate of approximately 75,556 rentable square feet for a new corporate headquarters in Sunnyvale, California, which will be recognized as an operating lease upon the lease commencement date.
+Added: The actual timing of lease commencement for accounting purposes, as well as the Company’s obligation to begin making payments and recognizing rental and other expenses, is dependent upon when the space is made available to the Company and the Company obtains control of the underlying asset.
+Added: The Company’s current estimate of the total estimated aggregate base rent payments, excluding the renewal option and option to expand into additional space, for this leased office space are approximately $ 62.1 million.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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:
−Removed: Three Months Ended Six Months Ended
−Removed: (in thousands) June 30,
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: Three Months Ended Nine Months Ended
+Added: (in thousands) September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
Cost of screening revenue (exclusive of amortization of intangible assets) $ 271 $ 400 $ 1,433 $ 1,321
11 unchanged sentences
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.
−Removed: As of June 30, 2025, approximately 382,005 shares remained available for future grants under the 2024 Plan.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: As of September 30, 2025, approximately 481,705 shares remained available for future grants under the 2024 Plan.
2024 Inducement Award Plan
14 unchanged sentences
Forfeited ( 518 ) $ 21.85
−Removed: Outstanding at June 30, 2025 5,289 $ 24.53
−Removed: Cash-Based Equity Awards and 2024 Transition Incentive Award
−Removed: In connection with the Spin-Off in June 2024, outstanding cash-based equity incentive award (the “Cash-Based Equity Awards”) and certain Cash-Based Equity Awards granted to GRAIL employees, including executives, for retention purposes in the second quarter of 2024 (the “2024 Transition Incentive Awards”) were converted into Company restricted stock units in accordance with the Employee Matters Agreement by dividing the aggregate award value by the volume-weighted average share price over the first four trading days following the Spin-Off.
+Added: Outstanding at September 30, 2025 5,107 $ 24.56
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: Cash-Based Equity Awards and 2024 Transition Incentive Awards
+Added: In connection with the Spin-Off in June 2024, outstanding cash-based equity incentive awards (the “Cash-Based Equity Awards”) and certain Cash-Based Equity Awards granted to GRAIL employees, including executives, for retention purposes in the second quarter of 2024 (the “2024 Transition Incentive Awards”), were converted into Company restricted stock units in accordance with the Employee Matters Agreement by dividing the aggregate award value by the volume-weighted average share price over the first four trading days following the Spin-Off.
As a result of the modification, the Cash-Based Equity Awards and 2024 Transition Awards, which were liability-classified awards prior to the Spin-Off, were reclassified as equity-classified awards.
The Cash-Based Equity Awards and the 2024 Transition Incentive Awards in the amount of $ 50.3 million and $ 4.4 million, respectively, were reclassified to Additional Paid-In Capital and converted into 4.0 million and 2.5 million RSUs, respectively.
−Removed: See Note 7 - Stock-based compensation in the Company’s Annual Report on Form 10-K (filed on March 5, 2025) for the year ended December 31, 2024 for further details.
+Added: See Note 7 - Stock-based compensation in the 2024 Form 10-K for the year ended December 31, 2024 for further details.
2024 Employee Stock Purchase Plan
1 unchanged sentence
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.
−Removed: As of June 30, 2025, 752,955 shares were available for issuance under the ESPP.
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: As of September 30, 2025, 752,955 shares were available for issuance under the ESPP.
Under the ESPP as currently implemented, eligible employees are offered shares through a six-month offering period commencing in May and November of each year.
Employees who participate in the ESPP may elect to have up to 15 % of their eligible compensation withheld to purchase shares of the Company’s common stock.
−Removed: The purchase price of the Company’s common stock will be equal to 85 % of the lower of the fair market value of the Company’s common stock on the beginning of each offering period or the fair market value of the Company’s common stock on the end of the six-month offering period.
+Added: The purchase price of the Company’s common stock will be equal to 85 % of the lower of the fair market value of the Company’s common stock at the beginning of each offering period or the fair market value of the Company’s common stock at the end of the six-month offering period.
The Company’s first offering period began in May 2025 with the first purchase date expected to take place in November 2025.
−Removed: No shares were offered under the ESPP during the three- and six-month periods ended June 30, 2024.
−Removed: No shares were issued under the ESPP during the three- and six-month periods ended June 30, 2025 or the three- and six-month periods ended June 30, 2024.
+Added: No shares were offered under the ESPP during the three and nine month periods ended September 30, 2024.
+Added: No shares were issued under the ESPP during the three and nine month periods ended September 30, 2025 or the three and nine month periods ended September 30, 2024.
The fair value of employee stock purchase rights under the ESPP have been estimated with the following assumptions using the Black-Scholes-Merton option-pricing model:
−Removed: Three and Six Months Ended
−Removed: June 30, 2025
+Added: Three and Nine Months Ended
+Added: September 30, 2025
Weighted-average assumptions:
5 unchanged sentences
The expected term represents the term from the first day of the offering period to the purchase date.
−Removed: The risk-free interest rate assumption was based upon observed interest rates on Treasury bills appropriate for the expected term.
+Added: The risk-free interest rate assumption was based upon observed interest rates of Treasury bills appropriate for the expected term.
The expected stock price volatility assumption was estimated using the average of the Company’s historical volatility and average volatility of the Company’s peer companies.
1 unchanged sentence
Expected dividend yield was 0 % as the Company has not paid and does not anticipate paying dividends on its common stock.
−Removed: As of June 30, 2025, unrecognized compensation costs related to the ESPP was $ 1.9 million and is expected to be recognized over a weighted average period of 0.4 years.
−Removed: Performance-Based Award
−Removed: During the quarter ended June 30, 2025, the Company granted performance-based restricted stock unit (“PSU”) awards under the 2024 Plan with vesting conditions tied to achievement of Company-specific performance and continued service.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: As of September 30, 2025, unrecognized compensation costs related to the ESPP was $ 0.6 million and is expected to be recognized over a weighted average period of 0.1 years.
+Added: Performance-Based Awards
+Added: During the nine months ended September 30, 2025, the Company granted performance-based restricted stock unit (“PSU”) awards under the 2024 Plan with vesting conditions tied to achievement of Company-specific performance and continued service.
One-third of the PSUs subject to the awards vest upon the achievement of a Company-specific performance condition and the remaining two-thirds of the PSUs subject to the awards vest in substantially equal installments upon each of the first and second anniversaries of the initial vesting date, in each case, subject to the holder’s continued service with the Company through the applicable vesting date.
−Removed: The PSU awards have an aggregate potential value of up to $ 1.0 million and expire, to the extent unvested, in May 2035.
−Removed: As of June 30, 2025, it was not probable that the performance conditions associated with the PSU awards will be achieved and, therefore, no stock-based compensation expense has been recognized in the unaudited condensed consolidated financial statements.
+Added: The PSU awards had an aggregate grant date fair value of $ 1.0 million and expire, to the extent unvested, in May 2035.
+Added: As of September 30, 2025, it was not probable that the performance conditions associated with the PSU awards will be achieved and, therefore, no stock-based compensation expense has been recognized in the unaudited condensed consolidated financial statements.
The Company also has one performance-based award outstanding for a former employee for which vesting is based on future revenues.
−Removed: The award has an aggregate potential value of up to $ 78.0 million and expires, to the extent unvested, in August 2030.
+Added: The award has an aggregate potential value of up to $ 78.0 million and expires, to the extent unvested, on August 27, 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.
1 unchanged sentence
If and to the extent that the liability becomes due and payable prior to 12:01 a.m.
−Removed: Eastern Time December 24, 2026 (the “Disposal Funding
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
−Removed: As of June 30, 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 unaudited condensed consolidated financial statements.
+Added: 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.
+Added: As of September 30, 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 unaudited condensed consolidated financial statements.
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.
−Removed: SEC Inquiry Letter
−Removed: GRAIL may also be a party or otherwise involved in new litigation proceedings regarding the Acquisition.
−Removed: 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, its products and the acquisition, and related to the conduct and compensation of certain members of Illumina and GRAIL management, among other things.
−Removed: GRAIL has cooperated with the SEC in this investigation.
−Removed: On May 9, 2025, the Company confirmed with the SEC that the SEC has closed its investigation into this matter.
Federal Securities Class Actions
19 unchanged sentences
On November 12, 2024, the Company moved to dismiss Lead Plaintiffs’ second amended complaint for failure to state a claim under Sections 10(b) and 20(a) of the Exchange Act.
−Removed: Lead Plaintiffs filed their opposition to the motion to dismiss on December 20, 2024, and the Company filed its reply in support of its motion to dismiss on February 3, 2025.
−Removed: The motion to dismiss is currently pending before the federal district court.
+Added: Lead Plaintiffs
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
+Added: filed their opposition to the motion to dismiss on December 20, 2024, and the Company filed its reply in support of its motion to dismiss on February 3, 2025.
+Added: On September 26, 2025, the court granted the motion to dismiss for failure to state a claim with leave to amend, and ordered the plaintiffs to file an amended complaint, if any, by October 27, 2025.
+Added: On October 27, 2025, the Lead Plaintiffs filed their third amended complaint.
The Company denies the allegations in the complaints and intends to vigorously defend the litigation.
4 unchanged sentences
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.
−Removed: There can be no assurance that existing or future legal proceedings arising in the
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
+Added: 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.
4 unchanged sentences
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.
−Removed: As of June 30, 2025, the Company is unable to estimate a range of possible loss in excess of the amounts accrued .
+Added: As of September 30, 2025, the Company is unable to estimate a range of possible loss in excess of the amounts accrued .
Contingencies
3 unchanged sentences
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.
−Removed: 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.
−Removed: The clawback is triggered if, prior to September 24, 2025 (the 15 -month anniversary of the Distribution Date), the 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).
−Removed: 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.
−Removed: 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.
−Removed: The amount of clawback payments made cannot exceed the amount of the initial disposal funding.
−Removed: As of June 30, 2025 , no contingency liability was recorded as the contingent loss is not probable.
+Added: 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, which was subject to a clawback feature that lapsed on September 24, 2025.
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.
1 unchanged sentence
Breach of any covenant or representation contained in the Tax Matters Agreement will result in liability to specific separation taxes.
−Removed: As of June 30, 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.
+Added: As of September 30, 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.
+Added: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 multi-cancer early detection (“MCED”) business and reduce overall spend as the Company progresses towards completion of registrational studies and premarket approval application (“PMA”) submission .
−Removed: The Restructuring Plan was
−Removed: NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: 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.
+Added: 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:
−Removed: Three Months Ended June 30, 2025 Six Months Ended June 30, 2025
+Added: Three Months Ended September 30, 2025 Nine Months Ended September 30, 2025
(in thousands) Severance and related benefit costs Other Costs Total Severance and related benefit costs Other Costs Total
6 unchanged sentences
$ — $ — $ — $ ( 161 ) $ 127 $ ( 34 )
−Removed: As of June 30, 2025, the Company had no remaining restructuring liability.
+Added: As of September 30, 2025, the Company had no remaining restructuring liability.
The following table summarizes the restructuring-related liabilities:
3 unchanged sentences
Cash payments made ( 645 ) ( 349 ) ( 994 )
−Removed: Amount recorded in accrued liabilities as of June 30, 2025 $ — $ — $ —
+Added: Amount recorded in accrued liabilities as of September 30, 2025 $ — $ — $ —
NET LOSS PER SHARE
2 unchanged sentences
This share amount is utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off.
−Removed: For the three and six months ended June 30, 2024, 31.0 million 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 to common stockholders:
−Removed: Three Months Ended Six Months Ended
−Removed: (in thousands, except share and per share data) June 30,
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: Three Months Ended Nine Months Ended
+Added: (in thousands, except share and per share data) September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
Net loss $ ( 88,977 ) $ ( 125,688 ) $ ( 309,175 ) $ ( 1,929,939 )
7 unchanged sentences
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:
−Removed: Three and Six Months Ended
−Removed: 2025 June 30,
+Added: Three and Nine Months Ended
+Added: September 30,
+Added: 2025 September 30,
Unvested restricted stock units 5,077,509 4,146,221
7 unchanged sentences
The Company’s estimated annual effective income tax rate may be revised, if necessary, in each interim period.
−Removed: The worldwide effective income tax rate for the six months ended June 30, 2025 and June 30, 2024 was 26.40 % and 3.37 %, respectively.
−Removed: The increase for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 primarily relates to the Company’s 2024 valuation allowance impacts against pre-tax losses prior to the Spin-off.
+Added: The worldwide effective income tax rate for the nine months ended September 30, 2025 and September 30, 2024 was 26.03 % and 5.45 %, respectively.
+Added: The increase for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 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.
−Removed: federal statutory rate for the six months ended June 30, 2025, primarily due to state taxes, offset by discrete tax benefits from stock-based compensation.
−Removed: The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and
−Removed: resolving uncertain tax positions.
−Removed: This evaluation is based on factors including, but not limited to, changes in facts
−Removed: or circumstances, changes in tax law, effectively settled issues under audit, and new audit activity.
−Removed: penalties related to unrecognized tax benefits are included within income tax expense.
−Removed: For the three months ended June 30, 2025, the Company recorded income tax expense related to its Federal and California research and development credits of $ 0.2 million and $ 0.1 million, respectively.
+Added: federal statutory rate for the nine months ended September 30, 2025, primarily due to state taxes, offset by discrete tax benefits from stock-based compensation.
+Added: The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions.
+Added: 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.
+Added: Interest and penalties related to unrecognized tax benefits are included within income tax expense.
+Added: For the three months ended September 30, 2025, the Company recorded income tax expense related to its Federal and California research and development credits of $ 0.5 million and $ 0.3 million, respectively.
The Company files income tax returns in the U.S.
federal jurisdiction and various states.
−Removed: As of the date of
−Removed: this filing, the Company is not currently under examination by income tax authorities in federal, state, or other
−Removed: jurisdictions.
−Removed: All tax returns will remain open for examination by the federal and state authorities for three and four
−Removed: years, respectively, from the date of utilization of any net operating loss or credits.
+Added: As of the date of this filing, the Company is not currently under examination by income tax authorities in federal, state, or other jurisdictions.
+Added: 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 , prior to the Spin-Off, for tax purposes, the Company operated as a subsidiary of Illumina and not as a separately regarded taxable entity.
9 unchanged sentences
The following table is representative of the significant expense categories regularly provided to the CODM when managing the Company’s single reporting segment.
−Removed: A reconciliation to the consolidated net loss for the three and six months ended June 30, 2025 and June 30, 2024 is included in the table below:
−Removed: Three Months Ended Six Months Ended
−Removed: (in thousands) June 30,
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: A reconciliation to the consolidated net loss for the three and nine months ended September 30, 2025 and September 30, 2024 is included in the table below:
+Added: Three Months Ended Nine Months Ended
+Added: (in thousands) September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
Screening revenue $ 32,807 $ 25,374 $ 96,319 $ 77,076
17 unchanged sentences
Goodwill and intangible assets impairment — — 28,000 1,420,936
−Removed: 28,000 1,420,936 28,000 1,420,936
Total costs and operating expenses 161,485 212,159 541,327 2,139,563
−Removed: 194,398 1,673,261 379,842 1,927,404
Loss from Operations ( 125,291 ) ( 183,507 ) ( 437,752 ) ( 2,052,220 )
−Removed: ( 158,854 ) ( 1,641,291 ) ( 312,461 ) ( 1,868,713 )
Other income (expense):
1 unchanged sentence
Other income (expense), net 466 ( 561 ) ( 929 ) ( 514 )
−Removed: ( 811 ) 5 ( 1,395 ) 47
Benefit from income taxes 29,741 46,719 108,811 105,428
2 unchanged sentences
See Note 8 — Stock-Based Compensation for further details.
+Added: (2) Cost of screening revenue (exclusive of amortization of intangible assets) and cost of development services revenue include $ 1.3 million and $ 4.9 million of depreciation expense for the three and nine months ended September 30, 2025 and $ 0.6 million and $ 3.8 million for the three and nine months ended September 30, 2024.
(3) Other segment expenses primarily includes costs related to contractors and temporary labor, marketing expenses, legal expenses, and credit loss expense .
5 unchanged sentences
Subsequent to the Spin-Off, Illumina retained a 14.5 % stake in the Company.
−Removed: As of June 30, 2025, Illumina held 4,502,126 shares of common stock representing a 12.5 % stake in the Company.
+Added: As of September 30, 2025, Illumina held 4,502,126 shares of common stock representing a 12.5 % stake in the Company.
Illumina is both a customer of the Company and a major supplier of the Company’s reagents and capital equipment.
1 unchanged sentence
Goods and services transactions with Illumina have been reflected in the unaudited condensed consolidated financial statements as follows:
−Removed: (in thousands) June 30,
+Added: (in thousands) September 30,
2025 December 31,
5 unchanged sentences
Three Months Ended
−Removed: Six Months Ended
−Removed: (in thousands) June 30,
−Removed: 2025 June 30,
−Removed: 2024 June 30,
−Removed: 2025 June 30,
+Added: Nine Months Ended
+Added: (in thousands) September 30,
+Added: 2025 September 30,
+Added: 2024 September 30,
+Added: 2025 September 30,
Screening revenue
15 unchanged sentences
The following table presents the components of the net transfers to and from Illumina prior to the Spin-Off:
−Removed: Six Months Ended
−Removed: (in thousands) June 30,
+Added: Nine Months Ended
+Added: (in thousands) September 30,
Cash funding received from Illumina $ 1,244,300
1 unchanged sentence
SUBSEQUENT EVENTS
−Removed: On July 4, 2025, the president signed into law the H.R.1, One Big Beautiful Bill Act (“the Act”).
−Removed: Among other things, the Act allows for the immediate expensing of domestic research and development expenditures, permanent 100% bonus depreciation on fixed assets placed in service after January 19, 2025, alters the calculation of the 163(j) limitation on the deductibility of interest expense, modifies the limitation on deductions for charitable contributions and expands the application of 162(m) limitations on the deductibility of executive compensation.
−Removed: These provisions are not expected to have a material impact on the company’s financial statements, however the Company will monitor the potential impact as additional guidance is available.
+Added: On October 16, 2025, the Company entered into a stock purchase agreement (the “Samsung Stock Purchase Agreement”), by and among the Company, Samsung C&T Corporation (“Samsung C&T”), Samsung Electronics Singapore Pte.
+Added: (together with Samsung C&T, the “Samsung Investors”) and Samsung Electronics Co., Ltd.
+Added: (“Samsung Electronics”), providing for the issuance and sale by the Company to the Samsung Investors in a private placement of an aggregate of 1,570,308 shares of GRAIL’s common stock, at a purchase price of $ 70.05 per share, upon the terms and conditions set forth in the Samsung Stock Purchase Agreement, including closing conditions, for aggregate gross proceeds of approximately $ 110.0 million (the “Samsung Investment”).
+Added: The closing of the Samsung Investment is subject to the satisfaction of certain conditions including, but not limited to, obtaining regulatory approvals and the execution of strategic collaboration agreements by January 31, 2026.
+Added: “Risk Factors” for more details.
+Added: The Company intends to use the net proceeds from the Samsung Investment to fund its commercial activities and reimbursement efforts, as well as for working capital and other general corporate purposes.
+Added: The Company is subject to a number of obligations described in the Samsung Stock Purchase Agreement.
+Added: The Samsung Stock Purchase Agreement contains customary representations, warranties and agreements by the Company, indemnification obligations of the Company and the Samsung Investors for liabilities under the Securities Act of 1933, as amended (the “Securities Act”), and other obligations of the parties.
+Added: On October 21, 2025, the Company, pursuant to a securities purchase agreement (the “Private Placement Purchase Agreement”) with the purchasers named therein, (each an “Investor”), completed the sale and issuance in a private placement of an aggregate of 2,640,970 shares of GRAIL’s common stock, or, for certain investors in lieu of GRAIL’s common stock, an aggregate 1,998,573 prefunded warrants to purchase shares of GRAIL’s common stock, with an exercise price of $ 0.001 per share (the “Pre-Funded Warrants”), at a price of $ 70.05 per share (or per Pre-Funded Warrants in lieu thereof, less the nominal exercise price of $ 0.001 per share) for aggregate gross proceeds of approximately $ 325.0 million, before deducting private placement expenses.
+Added: The Company intends to use the net proceeds from the Private Placement to fund its commercial activities and reimbursement efforts, as well as for working capital and other general corporate purposes.
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.