What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-13 compared with 2025-08-13 · 285 added, 220 removed, 404 unchanged (56% of the section changed)

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In these studies, Galleri demonstrated an ability to detect a shared cancer signal across more than 50 types of cancer, accurately predict the specific organ or tissue type where the cancer signal originated, and yield high positive predictive values (“PPV”) and low false positive rates, all from a simple blood draw.

As announced in May 2025 and June 2025, respectively, data from the NHS-Galleri prevalent screening round and initial data from approximately 25,000 PATHFINDER 2 participants demonstrated consistent performance as

compared to PATHFINDER in c ancer signal of origin (“ CSO”) accuracy and specificity, and substantially higher PPV.

As announced in May 2025, data from the prevalent screening round of the NHS-Galleri Trial demonstrated

consistent performance as compared to PATHFINDER in c ancer signal of origin (“ CSO”) accuracy and specificity, and substantially higher PPV.

In October 2025, performance and safety results from the first approximately 25,000 participants of our PATHFINDER 2 study were presented at the European Society of Medical Oncology (“ESMO”) Congress 2025, which showed a PPV of 61.6%, specificity of 99.6% and CSO accuracy of 92%.

In addition, the data demonstrated that adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF grade A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year, and an approximately three-fold increase when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF grade A, B, and C recommendations).

Galleri results can help guide next steps for diagnosis of cancer by healthcare providers in required follow-up diagnostic testing.

The high CSO accuracy demonstrated in our PATHFINDER 2 study led to efficient diagnostic workups.

Diagnostic resolution took a median of 46 days, and only 0.6% of all participants had an invasive procedure (159/25,114).

Invasive procedures were two times more common in participants with cancer than in those without.

We launched Galleri in the United States in mid-2021.

We have sold more than 370,000 commercial tests to-date, including more than 80,000 in the first half of 2025, which have detected some of the most aggressive cancers in early stages including, among others, endometrial, esophageal, gastric, head and neck, liver, pancreatic, and rectal cancers.

We have sold approximately 420,000 commercial Galleri tests through September 30, 2025, including more than 128,000 in the first nine months of 2025, which have detected some of the most aggressive cancers in early stages including, among others, endometrial, esophageal, gastric, head and neck, liver, pancreatic, and rectal cancers.

Since our inception, we have incurred net losses each year.

We incurred net losses of $114.0 million and $1.6 billion for the three months ended June 30, 2025 and June 30, 2024, respectively and $220.2 million and $1.8 billion for the six months ended June 30, 2025 and June 30, 2024, respectively (see “Basis of Presentation” below for a description of applicable fiscal periods).

Adjusted EBITDA was $(78.3) million and $(139.4) million for the three months ended June 30, 2025 and June 30, 2024, respectively and $(177.1) million and $(291.4) million for the six months ended June 30, 2025 and June 30, 2024 , respectively .

We incurred net losses of $89.0 million and $125.7 million for the three months ended September 30, 2025 and September 30, 2024, respectively and $309.2 million and $1.9 billion for the nine months ended September 30, 2025 and September 30, 2024, respectively (see “Basis of Presentation” below for a description of applicable fiscal periods).

Adjusted EBITDA was $(71.7) million and $(108.2) million for the three months ended September 30, 2025 and September 30, 2024, respectively and $(248.8) million and $(399.5) million for the nine months ended September 30, 2025 and September 30, 2024 , respectively .

Adjusted EBITDA is a n on-GAAP financial measure.

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We expect to continue to incur operating losses over at least the next several years as we continue to invest in research and development and commercialization of existing products.

Strategic Collaboration with Samsung and $110 million Equity Investment

In October 2025, we announced a strategic collaboration with Samsung C&T Corporation (“Samsung C&T”), Samsung Electronics Singapore Pte.

(together with Samsung C&T, the “Samsung Investors”) and Samsung Electronics Co., Ltd.

(“Samsung Electronics”).

As part of this strategic collaboration, we and Samsung C&T intend to work as exclusive partners to commercialize Galleri in Korea and, potentially, other key Asian markets, including Japan and Singapore.

In addition, we and Samsung Electronics intend to explore potential additional strategic and operational collaborations, such as supporting longitudinal genomic-lifestyle clinical research and the integration of Samsung Electronics’ health data platform with our technologies and data.

The beginning of any strategic collaboration activities with Samsung C&T or Samsung Electronics is subject to negotiation and execution of final agreements.

In connection with this strategic collaboration, we entered into a stock purchase agreement (the “Samsung Stock Purchase Agreement”), with the Samsung Investors and Samsung Electronics, providing for the issuance and sale by us to the Samsung Investors in a private placement of 1,570,308 shares of our common stock, at a purchase price of $70.05 per share, upon the terms and conditions set forth in the Samsung Stock Purchase Agreement, for aggregate gross proceeds of approximately $110.0 million (the “Samsung Investment”).

The closing of the Samsung Investment is subject to the satisfaction of certain conditions including, but not limited to (i) the satisfaction of certain regulatory approvals or clearances, including with respect to the Committee on Foreign Investment in the United States (“CFIUS”);

(ii) the execution of a business collaboration agreement by the Company and Samsung C&T by January 31, 2026 relating to, among other things, Samsung C&T’s exclusive right to commercialize the Company’s Galleri test, and obligation not to commercialize any other multi-cancer early detection test, in Korea, the funding of such commercialization by Samsung C&T, and a right of first negotiation for commercial rights to Japan and Singapore (iii) the execution of a strategic and operational collaboration agreement, in the form attached to the Stock Purchase Agreement, by the Company and Samsung Electronics by January 31, 2026, and (iv) certain other customary closing conditions.

We are subject to a number of obligations described in the Samsung Stock Purchase Agreement.

“Risk Factors”.

We intend to use the net proceeds from the Samsung Investment to fund our commercial activities and reimbursement efforts, as well as for working capital and other general corporate purposes.

$325 million Private Placement Financing

On October 21, 2025 (the “Closing Date”), we, 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 our common stock, or, for certain investors in lieu of our common stock, an aggregate of 1,998,573 prefunded warrants to purchase shares of our 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) (the “Private Placement”) for aggregate gross proceeds of approximately $325.0 million, before deducting private placement expenses.

We intend to use the net proceeds from the Private Placement to fund our commercial activities and reimbursement efforts, as well as for working capital and other general corporate purposes.

The Pre-Funded Warrants are immediately exercisable until exercised in full, subject to the Beneficial Ownership Limitation (as described below).

The Pre-Funded Warrants include cashless exercise rights.

Under the terms of the Pre-Funded Warrants, a holder will not be entitled to exercise any portion of any such warrant, if, upon giving effect to such exercise, the aggregate number of shares of our common stock beneficially owned by the holder (together with its affiliates, any other persons acting as a group together with the holder or any of the holder’s affiliates) would exceed 4.99% or 9.99%, as applicable (unless an Investor shall have elected otherwise), of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of such warrant, which percentage may be increased at the holder’s election upon 61 days’ notice to the Company, provided that such percentage may in no event exceed 19.99% (the “Beneficial Ownership Limitation”).

In addition, on October 18, 2025, in connection with the Private Placement Purchase Agreement, we entered into a registration rights agreement (the “Registration Rights Agreement”) with all of the Investors.

Pursuant to the Registration Rights Agreement, we agreed to prepare and file a registration statement with the Securities and Exchange Commission (the “SEC”) within 30 days after the Closing Date, for purposes of registering the resale of the shares of our common stock and the shares of our common stock issuable upon exercise of the Pre-Funded Warrants purchased in the Private Placement.

We agreed to use reasonable best efforts to cause such registration statement to be declared effective by the SEC on the earlier of (a) 60 days after the registration statement is filed or (b) 5 business days after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that the registration statement will not be “reviewed” or will not be subject to further review.

Prevalent Screening Round Results from the NHS-Galleri Trial

In May 2025, we completed a review of Galleri test performance results in the intervention arm from the prevalent screening round of the registrational NHS-Galleri Trial.

The prevalent screening round is the first round of blood draws (of the three total blood draw rounds in the trial) with one year of follow up.

Data from the prevalent screening round showed a substantially higher PPV than that observed in the PATHFINDER study and CSO accuracy and specificity that were consistent with that observed in the PATHFINDER study.

In the PATHFINDER study, the results of which were previously published in The Lancet,

Galleri demonstrated a PPV of 43%, CSO accuracy of 88%, and specificity of 99.5%.

There were no serious safety concerns in the prevalent screening round of the NHS-Galleri Trial.

The NHS-Galleri Trial is a fully enrolled prospective randomized controlled clinical utility trial of over 140,000 participants between the ages of 50 and 77 at the time of enrollment, to evaluate the implementation of Galleri alongside the existing NHS standard of care screenings.

The primary endpoint of the NHS-Galleri Trial is to evaluate Galleri’s ability to move forward the stage of cancer diagnosis relative to standard of care.

An analysis of data from the NHS-Galleri Trial will be conducted sequentially across three pre-specified cancer groupings.

First, we will assess whether such data demonstrates a statistically significant reduction in stage III and IV cancer in a pre-specified group of 12 cancer types that together represent approximately two-thirds of cancer deaths in the UK and US.

If a statistically significant reduction is found, the primary objective of the NHS-Galleri Trial will be met.

A subsequent analysis will assess whether the data demonstrates a significant reduction in all routinely staged cancer types other than prostate cancer.

If the second evaluation also shows a significant reduction, then all stageable cancers, including prostate, will be analyzed.

This stepwise approach concentrates first on cancers where there are the greatest unmet needs and where earlier detection could have the greatest potential impact on outcomes.

Secondary endpoints include collecting outcomes reported by participants with a cancer signal detected test over several time points, including an assessment of participants’ anxiety, satisfaction with Galleri, and attitudes regarding standard of care screening.

The NHS-Galleri Trial is designed to provide for three blood draws over a two-year period, with the first draw taken at enrollment, plus 12 months additional follow up after the last blood draw.

Cancer screening trials designed to show clinical utility are commonly conducted over three years with an annual screening interval, because data can be influenced by the fact that the first screening round detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed.

This and other factors are likely to cause final results of the three year trial to differ from a review of the first round results.

Although the NHS-Galleri Trial is not designed or statistically powered to detect a reduction in cancer-specific mortality, we believe the trial will provide relevant insights, including through modeled benchmarking against NHS cancer patients and a novel “nested mortality” analysis that focuses on where screening would confer benefit—among test-positive individuals—by retrospectively testing stored samples from control participants who are later diagnosed with cancer.

In addition, observed cancer-specific mortality will be reported at three and six years after the final screen.

We plan to submit data from the prevalent screening round of the NHS-Galleri trial, the first 25,000 participants in the PATHFINDER 2 study, and a bridging analysis (comparing and measuring concordance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri Trial with the updated version of the Galleri test that we plan to submit to the FDA for premarket approval) as part of our PMA in the first quarter of 2026.

Final clinical utility results from all three years of the trial are expected in mid-2026.

Results from the PATHFINDER 2 Registrational Study

PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in a population of individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.

PATHFINDER 2 was initiated in 2021 and includes 35,878 adults in the United States and Canada aged 50 years and older with no clinical suspicion of cancer.

In June 2025, we announced positive top-line performance and safety results from a pre-specified analysis of the first 25,578 participants in the registrational study.

Data from the analyzable performance cohort of 23,161 participants with 12 months of follow-up demonstrated that adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF grade A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year, and an approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations).

Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options.

Approximately 0.9% of participants received a cancer signal detected result.

Additionally, among participants who received a cancer signal detected from Galleri and had a confirmed new cancer diagnosis (true positive), more than half (53.5%) of the new cancers detected were stage I or II and more than two-thirds (69.3%) were stage I, II or III.

Data demonstrated a PPV of 61.6%, specificity of 99.6%, resulting in a false positive rate of 0.4%, and CSO accuracy of 92%.

The high CSO accuracy led to efficient diagnostic workups, with a median time to diagnostic resolution of 46 days following test results, and only 0.6% of all participants had an invasive procedure, with invasive procedures two times more common in participants with cancer than in those without.

Data also demonstrated episode sensitivity, or the ability to detect cancer that could be confirmed within 12 months after the blood draw, was 73.7% for the 12 cancer types that together represent approximately two-thirds of cancer deaths and 40.4% for all cancer types.

No serious, study-related adverse events were reported during the diagnostic workup.

We plan to submit the data from the first approximately 25,000 participants in the PATHFINDER 2 study, the prevalent screening round of the NHS-Galleri Trial, and a bridging analysis (comparing and measuring concordance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri Trial with the updated version of the Galleri test that we plan to submit to the FDA for premarket approval) as part of our PMA in the first quarter of 2026.

In 2021, we published modeling data in Cancer Epidemiology, Biomarkers & Prevention (Cancer Epidemiol Biomarkers Prev.

30:460-8) that estimated the potential impact of MCED testing on mortality reduction based on test performance in our CCGA-2 study and using 2006 to 2015 data from the Surveillance, Epidemiology, and End Results Program of the U.S.

National Cancer Institute (“SEER”) for ages 50-79.

In applying the results from our PATHFINDER 2 and CCGA-3 studies to this modeling data, we estimate that in a population of approximately 107 million individuals between the ages of 50-79 in the United States, adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) could result in the detection of an additional approximately 480,000 cancer cases.

The updated model shows that the use of Galleri together with standard of care screenings could lead to the detection of three times as many cancer cases overall as compared to standard of care screenings alone, with only approximately 4.6% more incremental false positives.

We estimate that identification of many more cancer cases with a limited number of additional false positives would reduce the cost to diagnose one cancer by approximately 65%.

Results from SYMPLIFY Extended Registry Data

In October 2025, we and the University of Oxford announced that positive long-term results from an extended registry follow-up of the SYMPLIFY study were presented at the Early Detection of Cancer Conference (“EDCC”).

SYMPLIFY is a prospective multi-center observational study and represents the first large-scale evaluation of an MCED test in symptomatic patients who were referred from the primary care setting due to clinical suspicion of cancer.

This patient population represents a distinct patient population from the asymptomatic screening population assessed in the PATHFINDER and PATHFINDER 2 studies and the NHS-Galleri Trial.

This study was initiated in July 2021 and completed enrollment in November 2021.

The study enrolled 6,238 patients, aged 18 years and older, in England and Wales who were referred for urgent imaging, endoscopy or other diagnostic modalities to investigate symptoms suspicious for possible cancer.

Of the total enrolled patients, there were 5,461 evaluable patients who achieved diagnostic resolution.

The Company’s test was performed in batches, blinded to clinical outcome, and the test’s cancer signal detected and cancer signal origin prediction results were compared with the diagnosis obtained by standard of care pathways to assess test performance.

The primary analysis of the SYMPLIFY study, previously published in The Lancet Oncology, supported the feasibility of using the Galleri test to assist clinicians with decisions regarding referral from primary care.

In that analysis, which followed participants until diagnostic resolution or up to nine months, Galleri demonstrated a PPV of 75.5% and CSO accuracy of 84.8%.

Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales.

The updated analysis presented at EDCC showed that 35.4% (28 of 79) of participants initially believed to have a false positive Galleri result were later diagnosed with cancer during the 24 month follow up period.

This reduction in false positives to 51 from 79 resulted in an increase of PPV in this symptomatic population to 84.2% from 75.5%, and 27 of these 28 participants had a correct CSO prediction.

These updated results demonstrate the importance of continued follow-up after a cancer signal is detected.

Real World Evidence Results

In April 2025, we presented results from more than 100,000 patients at the American Association for Cancer Research Annual Meeting collected in a real-world setting from over 9,000 healthcare providers across the U.S.

who ordered Galleri tests and had results returned to their patients.

Clinical cancer outcomes were voluntarily provided by ordering providers to GRAIL.

In this population, 1,011 patients received a positive Galleri test result.

Of those, 459 patients had follow up information reported to us by their provider.

411 of those patients had a completed diagnostic workup, 259 of whom had received their Galleri test for asymptomatic screening.

Test performance in these 259 patients was consistent with that observed in our prior clinical studies for asymptomatic screening, with a PPV of the Galleri test of 49% and CSO accuracy of 87%.

Because of differences in sample size, age distributions, the limitations of collecting data in a real-world setting through voluntary reporting, the importance of work ups and other factors, these results are not directly comparable to the results of our clinical studies, such as our PATHFINDER or PATHFINDER 2 studies or the prevalent screening round or full trial results of our NHS-Galleri Trial.

Separation from Illumina

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On June 21, 2024, in connection with the Spin-Off, we received a cash contribution of $932.3 million from Illumina.

In connection with the Spin-Off, we incurred $21.9 million of legal and professional fees in the six month period ended June 30, 2024 related to the 2021 acquisition of GRAIL by Illumina, and corresponding antitrust litigation, including compliance with the hold separate arrangements imposed by the European Commission, and divestiture of GRAIL from Illumina through the Spin-Off.

In connection with the Spin-Off, we incurred $22.2 million of legal and professional fees in the nine month period ended September 30, 2024 related to the 2021 acquisition of GRAIL by Illumina, and corresponding antitrust litigation, including compliance with the hold separate arrangements imposed by the European Commission, and divestiture of GRAIL from Illumina through the Spin-Off.

See “Non-GAAP Financial Measures — Adjusted EBITDA” for further details.

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Restructuring Plan

overall spend as we progress towards completion of registrational studies and premarket approval application (“PMA”) submission to the U.S.

On Augu st 9, 2024, following a portfolio review, our Board of Directors (the “Board”) approved a restructuring plan (“Restructuring Plan”) designed to reprioritize our resources to focus on our core MCED business and reduce overall spend as we progress towards completion of registrational studies and premarket approval application (“PMA”) submission to the U.S.

Food and Drug Administration (“FDA”) for Galleri.

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The Restructuring Plan was substantially completed in the fourth quarter of 2024, and we incurred $18.3 million of total charges through the fourth quarter of 2024, consisting primarily of employee severance, benefits, payroll taxes, and other associated costs .

For the three and six months ended June 30, 2025 , we incurred an immaterial amount of restructuring charges.

Prevalent Screening Round Results from the NHS-Galleri Trial

In May 2025, we completed a review of Galleri test performance results in the intervention arm from the prevalent screening round of the registrational NHS-Galleri trial.

The prevalent screening round is the first round of blood draws (of the three total blood draw rounds in the trial) with one year of follow up.

Data from the prevalent screening round showed a substantially higher PPV than that observed in the PATHFINDER study, which was previously published in The Lancet .

CSO accuracy and specificity were consistent with that observed in the PATHFINDER study.

In PATHFINDER, Galleri demonstrated a PPV of 43%, CSO accuracy of 88%, and specificity of 99.5%.

There were no serious safety concerns in the NHS-Galleri prevalent screening round.

The NHS-Galleri trial is a clinical utility trial of over 140,000 participants to evaluate the implementation of Galleri alongside the existing NHS standard of care screenings.

The NHS-Galleri trial was designed as three annual blood draws, plus 12 months follow up, in order to evaluate Galleri’s ability to move forward the stage of cancer diagnosis relative to standard of care (primary endpoint).

This and other factors are likely to cause final results of the three year trial to differ from a review of the first round results.

We plan to submit data from the prevalent screening round of the NHS-Galleri trial, the first 25,000 participants in the PATHFINDER 2 study, and a bridging study (comparing the version of Galleri used in the NHS-Galleri and the PATHFINDER 2 trials to the updated version that we plan to submit to the FDA for premarket approval) as part of our PMA in the first half of 2026.

Final clinical utility results from all three years of the trial are expected in mid-2026.

Top-Line Results from the PATHFINDER 2 Registrational Study

In June 2025, we announced positive top-line performance and safety results from a pre-specified analysis of the first 25,578 participants in the registrational PATHFINDER 2 study.

PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer.

In the previously published PATHFINDER study, adding Galleri to standard of care cancer screening more than doubled the overall number of cancers detected by screening.

Data from evaluable PATHFINDER 2 participants with 12 months of follow-up showed that adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in the original PATHFINDER study.

In addition, Galleri’s PPV was substantially higher than the 43% observed in the PATHFINDER study, with consistent specificity and CSO accuracy.

There were no serious safety concerns reported in PATHFINDER 2.

PATHFINDER 2 study results will be submitted to the FDA as part of the Galleri PMA, along with a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study to the updated version that GRAIL plans to submit to the FDA for premarket approval.

Detailed results from the pre-specified analysis of the first 25,000 patients in the registrational PATHFINDER 2 study will be submitted for presentation at the European Society for Medical Oncologists Congress 2025.

Real World Evidence Results

who ordered Galleri tests and had results returned to their patients.

Clinical cancer outcomes were voluntarily provided by ordering providers to GRAIL.

In this population, 1,011 patients received a positive Galleri test result.

Of those, 459 patients had follow up information reported to us by their provider.

411 of those patients had a completed diagnostic workup, 259 of whom had received their Galleri test for asymptomatic screening.

Test performance in these 259 patients was consistent with that observed in our prior clinical studies for asymptomatic screening, with a PPV of the Galleri test of 49% and CSO accuracy of 87%.

Because of differences in sample size, age distributions, the limitations of collecting data in a real-world setting through voluntary reporting, the importance of work ups and other factors, these results are not directly comparable to the results of our clinical studies, such as our PATHFINDER or PATHFINDER 2 trials or the prevalent screening round or full trial results of our NHS-Galleri trial.

For the three and nine months ended September 30, 2025 , we incurred an immaterial amount of restructuring charges.

Basis of Presentation

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While GRAIL was a subsidiary of Illumina, GRAIL’s fiscal year was the 52 or 53 weeks ending the Sunday closest to December 31, with quarters of 13 or 14 weeks ending the Sunday closest to March 31, June 30, September 30, and December 31.

The three months ended June 30, 2025 and June 30, 2024, respectively, were both 13 weeks.

The three months ended September 30, 2025 and September 30, 2024, respectively, were both 13 weeks.

Upon the closing of the Spin-Off, GRAIL adopted a fiscal year end of December 31.

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We plan to pursue FDA approval to help support broad access for Galleri in the United States.

We plan to complete a PMA submission with the FDA in the first half of 2026.

The timing of this submission is subject to various risks and other factors, including the completion of clinical studies and our ongoing discussions with the FDA.

We plan to complete a PMA submission with the FDA in the first quarter of 2026.

The timing of this submission is subject to various risks and other factors, including the finalization of our clinical evidence package, including our bridging analyses, and our ongoing discussions with the FDA.

Obtaining PMA approval can take several years from the time an application is submitted, if at all.

it is difficult to predict what information we will need to submit to obtain approval of a PMA from the FDA for a proposed intended use or at all.

Moreover, the FDA requirements that will govern MCED tests, as well as the breadth and nature of data we must provide the FDA to support the proposed intended use, may be subject to change, and as such it is difficult to predict what information we will need to submit to obtain approval of a PMA from the FDA for a proposed intended use or at all.

Moreover, the regulatory requirements surrounding the pathway to PMA for LDTs may be subject to change, including through a recent court decision that has successfully challenged the FDA’s authority to implement medical device requirements with respect to LDTs.

We continue to interact with the FDA regarding the data we must provide the FDA to support our PMA submission for the proposed intended use.

We believe that FDA approval, if obtained, could unlock large commercial payors in the United States and we are supporting proposed legislation in the United States to enable coverage of FDA-approved MCED tests by Medicare.

We believe that FDA approval, if obtained, could unlock coverage from large commercial payors in the United States and we are supporting proposed legislation in the United States to enable coverage of FDA-approved MCED tests by Medicare.

If we obtain FDA approval, we expect to pursue inclusion of Galleri in the USPSTF’s guideline recommendation, although such inclusion is not certain even with FDA approval.

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We believe the decision will include considerations such as NHS budget, political priorities, cost-effectiveness and implementation constraints in addition to an evaluation of the final results.

We believe our work with the NHS and data generated from our NHS-Galleri Trial, if favorable, could help facilitate adoption in other single-payor systems around the world and support evidence of clinical utility worldwide.

We believe our work with the NHS and data

generated from our NHS-Galleri Trial, if favorable, could help facilitate adoption in other single-payor systems around the world and support evidence of clinical utility worldwide.

• International expansion .

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We have expanded our research internationally into the United Kingdom through our partnership with NHS England in the NHS-Galleri Trial, and we expect to launch Galleri in the United Kingdom, subject to the results of our NHS-Galleri Trial.

We continue to evaluate international expansion opportunities and we have begun expansion in select additional geographies through distributors.

We continue to evaluate international expansion opportunities and we have begun expansion in select additional geographies through distributors, including most recently through our proposed strategic collaboration with Samsung C&T in Korea.

We expect to continue selectively engaging with international opportunities over time.

• Continued development of the market for MCED testing .

• Continued development of, and competition within, the market for MCED testing .

Multi-cancer early detection is a relatively novel technology and the market for MCED tests is evolving.

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We make significant efforts to educate these key stakeholders regarding the benefits of MCED and the clinical and economic value of our products, which we believe will continue to drive awareness of MCED and expand the commercial opportunity for our products.

Additionally, new MCED products have launched co mmercially in the second half of 2025.

We believe that the addition of new market entrants will help develop the market for MCED testing.

However, these competitors will also be targeting similar markets as us and may present clinical or other information, such as test performance information, that differs from our own presentation of similar information.

Our ability to differentiate Galleri from other MCED products and any such presented data will be a key factor in our success.

We believe we are differentiated by our extensive and robust datasets generated from our clinical studies, our rigorous and objective approach to test development and research, our multidisciplinary capabilities leveraging the power of next-generation sequencing and advanced and trained machine learning algorithms and data science, our robust intellectual property portfolio, and our investment in our facilities and operational workflows.

However, certain new market entrants may have greater financial resources, quicker reimbursement timelines, larger sales forces, more successful marketing campaigns, more experience in screening or international commercialization, lower prices or other advantages.

Our ability to succeed will depend on our market success.

“Risk Factors”.

• Demand for our products and customer mix .

A key factor to our future success is and will be our ability to increase demand for, and sales of, Galleri from new and existing customers.

Our commercial strategy is focused on innovative value-oriented partnerships and targets primary care physicians, health systems, employers, payors, and life insurance providers.

Our commercial strategy is focused on innovative value-oriented partnerships and targets primary care physicians, digital health platforms, health systems, employers, payors, and life insurance providers.

As Galleri is not currently broadly reimbursed, our ability to drive demand from these customers is directly linked to our ability to demonstrate the clinical and economic value of our test through clinical validation and real-world experience.

As of June 30, 2025, we have entered into commercial partnerships, including with leading healthcare systems, employers, payors, and life insurance providers, and have established a network of over 15,000 prescribers across the United States in a pre-reimbursement setting.

As of September 30, 2025, we have entered into commercial partnerships, including with leading digital health platforms, healthcare systems, employers, payors, and life insurance providers, and have established a network of over 16,000 prescribers across the United States in a pre-reimbursement setting.

We believe this commercial network represents a significant opportunity to drive further demand for Galleri.

The mix of customers from which we generate revenue from period to period has an impact on our revenue and gross margin.

Galleri test pricing is generally based on our list price or, for certain customers, such as larger, higher-volume customers, negotiated contractual rates.

For certain customers, we also offer rebates or discounts.

Galleri test pricing is generally based on our list price, with discounts across channels that vary based on the size and type of account that is offering the test.

F or certain customers, we also offer rebates or discounts.

Revenue generated from customers with negotiated contractual rates, or with rebates or discounts, is generally lower margin as compared to revenue generated based on list pricing.

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In addition, we have entered into a number of biopharmaceutical research partnerships for our research-use-only (“RUO”) offering under our precision oncology portfolio.

Large customers, such as healthcare systems, employers, and biopharmaceutical partners, generally

begin using our products by initiating pilots involving a limited number of tests.

Large customers, such as healthcare systems, employers, and biopharmaceutical partners, generally begin using our products by initiating pilots involving a limited number of tests.

We believe that our ability to convert these initial pilots into long-term customer relationships has the potential to drive substantial long-term revenue.

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We expect our research and development expenses to decrease over the next three years as, in conjunction with our portfolio review, we determined to decrease investment in product programs beyond Galleri.

Additionally, some of our large clinical trials are moving into the data follow-up phase and the development of our automated platform is expected to substantially conclude in 2025.

We will continue to prioritize key objectives for Galleri, including completion of our registrational studies and submission of our PMA application.

Additionally, some of our large clinical trials are moving into the data follow-up phase, an updated commercial version of our Galleri test incorporating an automated platform was deployed in 2024 and we expect that we have substantially completed development of the Galleri test version that we will submit with our PMA.

We will continue to prioritize key objectives for Galleri, including finalization of our clinical evidence package and submission of our PMA application.

• Leverage our operational infrastructure .

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As demand for our products increases, we expect to further leverage the scale efficiencies of our infrastructure and platform technology, which we believe will positively impact margins over time.

In late 2024, we began use of a new version of Galleri, for which we are submitting our PMA, in commercial channels that incorporates an industrial scale platform with significant automation and is intended to enable us to scale more efficiently with future demand.

In late 2024, we began using an updated commercial version of Galleri in commercial channels.

This version incorporates an industrial scale platform with significant automation and is intended to enable us to scale more efficiently with future demand.

In connection with implementation of this new version of Galleri, we have experienced and may continue to experience increased turnaround times, re-processing costs and sample failures.

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While each of these areas presents significant opportunities for us, they also pose significant risks and challenges that we must address.

See the “Risk Factors” section of our 2024 Form 10-K (filed on March 5, 2025) and the “Risk Factors” section of this Form 10-Q, alongside other information set forth in this Form 10-Q and in other documents that we file with the SEC, for more information.

See the “Risk Factors” section of our 2024 Form 10-K and Item 1A.

“Risk Factors” of this Form 10-Q, alongside other information set forth in this Form 10-Q and in other documents that we file with the SEC, for more information.

Seasonal fluctuations and underlying business trends have also affected, and are likely to continue to affect, our business.

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Galleri is not currently broadly reimbursed.

The test price is based on the negotiated contractual rate with our contracted customers, otherwise our standard list price applies.

Galleri test pricing is generally based on our list price, with discounts across channels that vary based on the size and type of account that is offering the test.

F or certain customers, we also offer rebates or discounts.

We identify each sale of our test to our customer as a single performance obligation;

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We expense both internal and external research and developm ent costs in the periods in which they are incurred.

Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities are deferred and recognized as expense in the period in which the related goods are delivered or services are performed.

Nonrefundable advance payments for goods and services that will be used or rendered in future research and development activities are deferred and recognized as expenses in the period in which the related goods are delivered or services are performed.

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The cost of identifiable intangible assets with finite lives, such as trade names, are amortized on a straight-line basis over the assets’ respective estimated useful lives of 9 years.

We expect our sales and marketing expense s to decrease in the near term as a result of the implementation of the Restructuring Plan, and then to remain flat-to-increasing and continue to decrease as a percentage of revenue over the next three years and long term.

We expect our sales and marketing expense s to remain flat-to-increasing and continue to decrease as a percentage of revenue over the next three years and long term.

General and Administrative

G&A expenses consist of personnel expenses, including salaries, benefits and stock-based compensation expense, for executive, finance and accounting, legal, human resources, business development, corporate communications, medical affairs and management information systems personnel.

G&A expenses consist of personnel expenses, including salaries, benefits and stock-based compensation expenses, for executive, finance and accounting, legal, human resources, business development, corporate communications, medical affairs and management information systems personnel.

Also included are professional fees, legal costs, including patent and trademark-related expenses and educational activities.

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W e have incurred and will incur additional expenses as a result of operating as a public company, including expenses related to compliance with the rules and regulations of the SEC, director and officer insurance premiums, investor relations activities, and other expenses related to administrative and professional services.

We expect our G&A expenses to decrease in the near term following implementation of the Restructuring Plan in the third and fourth quarter 2024, and then to remain flat-to-increasing and continue to decrease as a percentage of revenue over the next three years and long term.

We expect our G&A expenses to remain flat-to-increasing and continue to decrease as a percentage of revenue over the next three years and long term.

Goodwill and Intangible Assets Impairments

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We evaluate intangible assets for impairment annually or more frequently if an event occurs or circumstances change in the interim that would more likely than not reduce the fair value of the asset below its carrying amount.

See Note 2 — Summary of Significant Accounting Policies — Goodwill and Intangible Assets to our Consolidated Financial Statements filed with our 2024 Form 10-K.

See Note 4 — Goodwill and Intangible Assets included in this Form 10-Q.

Interest Income

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Including the provision for income taxes in our standalone financials is more representative of our financial position as a standalone company.

As such, the income tax provisions and related deferred tax assets and liabilities reflected in our financial statements for the period ending June 30, 2024 has been estimated as if we were a separate taxpayer.

As such, the income tax provisions and related deferred tax assets and liabilities reflected in our financial statements for the periods prior to the Spin-Off have been estimated as if we were a separate taxpayer.

Under this method, various tax attributes, such as net operating losses and tax credits, are also presented on a separate return basis.

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Beginning in 2024 after the Spin-off, as a standalone entity, GRAIL will file tax returns on its own behalf and its deferred taxes and actual income tax rate may differ from those in historical periods.

During 2025 the Company is no longer a subsidiary of Illumina and computes its tax provision in accordance with ASC 740 and has computed the income tax provision, including the current and deferred taxes under Grail, Inc., as a publicly traded company.

As of the Spin-off, the Company is no longer a subsidiary of Illumina and computes its tax provision in accordance with ASC 740 and has computed the income tax provision, including the current and deferred taxes under Grail, Inc., as a publicly traded company.

Results of Operations

Comparisons of the Three and Six Months Ended June 30, 2025 and June 30, 2024

The following table summarizes our results of operations for the three and six months ended June 30, 2025 and June 30, 2024.

Three Months Ended Six Months Ended

(in thousands) June 30,

2025 June 30,

2024 June 30,

2025 June 30,

Comparisons of the Three and Nine Months Ended September 30, 2025 and September 30, 2024

The following table summarizes our results of operations for the periods indicated:

Three Months Ended Nine Months Ended

(in thousands) September 30,

2025 September 30,

2024 September 30,

2025 September 30,

Screening revenue $ 32,807 $ 25,374 $ 96,319 $ 77,076

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Net loss $ (88,977) $ (125,688) $ (309,175) $ (1,929,939)

Comparison of the Three Months Ended June 30, 2025 and June 30, 2024

Comparison of the Three Months Ended September 30, 2025 and September 30, 2024

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

(in thousands) September 30,

2025 September 30,

Screening revenue

$ 32,807 $ 25,374 $ 7,433 29 %

Development services revenue

1,165 3,807 (2,642) (69 %)

Total revenue 35,544 31,970 3,574 11 %

Screening Revenue

The increase in screening revenue of $6.2 million was primarily attributable to a 29% increase in Galleri sales volume, offset by a 6% decrease in ASP.

The Galleri sales volume increased in the second quarter of 2025 as a result of the continued ramp in our commercial activity, expansion of our network of ordering providers, additional commercial partnerships and new promotional campaigns.

Development Services Revenue

The decrease in development services revenue of $2.6 million was primarily due to a decrease of $1.2 million in revenue from pilots with biopharmaceutical partners, a decrease of $0.7 million in revenue earned from research services, and a decrease of $0.5 million in other services revenue.

The increase in screening revenue of $7.4 million was primarily attributable to a 39% increase in Galleri sales volume, partially offset by a 7% decrease in ASP.

The Galleri sales volume increased in the third quarter of 2025 as a result of the continued ramp in our commercial activity, expansion of our network of ordering providers, additional commercial partnerships and new promotional campaigns.

Cost of Screening Revenue (Exclusive of Amortization of Intangible Assets)

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

(in thousands) September 30,

2025 September 30,

Cost of screening revenue (exclusive of amortization of intangible assets)

$ 15,910 $ 15,970 $ (60) — %

The increase in cost of screening revenue (exclusive of amortization of intangible assets) of $3.6 million was primarily attributable to an increase in test volume.

Cost of screening revenue (exclusive of amortization of intangible assets) as a percent of revenue decreased in the second quarter of 2025 compared to the same period in 2024 primarily due to the reduction in variable costs of Galleri testing performed on our automated platform;

however, this decrease was offset by the 6% decrease in ASP and additional sample reprocessing costs.

The cost of screening revenue (excluding amortization of intangible assets) remained flat, primarily due to an increase in test volume offset by lower variable cost per sample of Galleri testing performed on our automated platform and a clinical validation activity, which resulted in higher fixed costs being allocated to operating expenses.

Cost of screening revenue (exclusive of amortization of intangible assets) as a percent of screening revenue decreased 14%, mainly due to lower costs of Galleri testing performed on our automated platform, partially offset by the 7% decrease in ASP and higher sample reprocessing costs.

Research and Development

Research and development expenses for the three months ended June 30, 2025 and June 30, 2024 were as follows:

Research and development expenses for the three months ended September 30, 2025 and September 30, 2024 were as follows:

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

(in thousands) September 30,

2025 September 30,

Compensation expenses $ 24,437 $ 43,317 $ (18,880) (44 %)

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Total research and development $ 48,647 $ 78,231 $ (29,584) (38 %)

The decrease in research and development expenses by $47.6 million was primarily attributable to decreases in compensation expenses, clinical study expenses, and laboratory supplies and research collaboration expenses.

The decrease of $20.8 million in compensation expenses was primarily related to a decrease of $13.2 million in salaries and wages, a decrease of $5.9 million in stock-based compensation, and a decrease of $1.7 million in variable compensation expense primarily due to the reduction in workforce related to the Restructuring Plan.

The decrease in clinical studies of $10.1 million was primarily due to a decrease of $11.0 million primarily related to completion of enrollment in our PATHFINDER 2 study and completion of final study visits in our NHS-Galleri Trial, partially offset by an increase of $0.9 million due to enrollment in our REACH/Galleri-Medicare study.

The decrease in laboratory supplies and research collaboration expenses of $7.4 million was primarily driven by the completion of the development and validation of our automated platform at the end of 2024 as well as the completion of enrollment in our PATHFINDER 2 study and completion of final study visits in our NHS-Galleri Trial.

The decrease of $5.4 million in allocated expenses was primarily attributable to lower software, IT, and facilities expenses being allocated to the research and development function.

The decrease of $3.8 million in other expenses was primarily driven by a decrease in professional services and in the use of contractors and temporary labor due to cost optimization efforts.

The decrease in research and development expenses of $29.6 million was primarily attributable to decreases in compensation expenses, laboratory supplies and research collaboration expenses, allocated expenses, and other expenses.

The decrease of $18.9 million in compensation expenses was primarily related to a decrease of $8.8 million in severance and benefits, a decrease of $8.7 million in salaries and wages, and a decrease of $2.5 million in stock-based compensation primarily due to the reduction in workforce related to the Restructuring Plan, partially offset by an increase of $1.1 million in variable compensation expense primarily due to the one-time benefit recorded in the prior period related to the Restructuring Plan.

The decrease in laboratory supplies and research collaboration expenses of $5.3 million was primarily driven by the substantial completion of the development and validation of our automated platform at the end of 2024 as well as the completion of enrollment in our PATHFINDER 2 study and completion of final study visits in our NHS-Galleri Trial.

The decrease of $2.9 million in allocated expenses was primarily attributable to ongoing cost reduction efforts, which resulted in lower software, IT, and facilities expenses being allocated to the research and development function.

The decrease of $2.2 million in other expenses was primarily driven by a $0.8 million decrease in the use of contractors and temporary labor, a decrease of $0.7 million in cloud computing, and a decrease of $0.6 million in professional services due to cost optimization efforts.

Sales and Marketing

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

(in thousands) September 30,

2025 September 30,

Sales and marketing $ 25,503 $ 35,625 $ (10,122) (28 %)

The decrease in sales and marketing expenses of $12.5 million was primarily attributable to a decrease of $9.3 million in compensation expenses primarily related to a decrease in salaries and wages of $6.8 million and a decrease in stock-based compensation of $2.1 million primarily due to the reduction in workforce related to the Restructuring Plan.

The decrease in sales and marketing expenses of $10.1 million was primarily attributable to a decrease of $7.6 million in compensation expenses primarily related to a decrease in severance and benefits of $4.8 million and a decrease in salaries and wages of $3.2 million primarily due to the reduction in workforce related to the Restructuring Plan, partially offset by an increase of $0.4 million primarily related to variable compensation expense due to the one-time benefit recorded in the prior period related to the Restructuring Plan.

Third-party marketing professional services expenses decreased by $2.2 million due to cost optimization efforts.

1 unchanged sentence

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

(in thousands) September 30,

2025 September 30,

General and administrative

$ 37,408 $ 47,418 $ (10,010) (21 %)

The decrease in general and administrative expenses of $29.3 million was primarily attributable to a decrease of $19.1 million in legal and professional services expenses due to no longer incurring legal and professional service fees related to compliance with the European Commission hold separate order and transaction costs related to our Spin-Off, which completed on June 24, 2024.

Compensation expenses decreased by $7.5 million primarily related to a decrease of $3.7 million in stock-based compensation, a decrease in salaries and wages of $3.0 million, and a decrease of $0.8 million in variable compensation primarily due to the reduction in workforce related to the Restructuring Plan.

The decrease in general and administrative expenses of $10.0 million was primarily attributable to a decrease of $6.7 million in compensation expenses primarily related to a decrease of $5.6 million in severance and benefits and a decrease of $1.5 million in salaries and wages due to the reduction in workforce related to the Restructuring Plan, partially offset by an increase of $0.9 million in variable compensation due to the one-time benefit recorded in the prior period related to the Restructuring Plan.

Legal and professional services expenses decreased by $2.5 million primarily due to lower outside counsel and litigation related spend and consulting fees.

Costs associated with the use of contractors and temporary labor decreased by $2.2 million due to cost optimization efforts.

Goodwill and Intangible Assets Impairment

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

Goodwill and intangible impairment

$ 28,000 $ 1,420,936 $ (1,392,936) (98 %)

In the second quarter of 2025, we identified a change in market conditions in relation to our IPR&D asset which is in development, which represented a potential impairment indicator.

An impairment assessment was performed which resulted in an impairment charge of $28 million primarily due to a decrease in projected cash flows and a higher discount rate.

As a result of a goodwill impairment assessment performed by Illumina in the second quarter of 2024, a goodwill impairment charge of $888.9 million was recorded, which represents the amount by which the net carrying value of GRAIL exceeded the fair value of GRAIL at the time the quantitative test was performed, primarily due to changes to the forecast of GRAIL’s value and the method for valuing GRAIL .

In conjunction with the goodwill impairment assessment, an impairment assessment for our IPR&D intangible assets was performed by Illumina which resulted in an impairment charge of $420.0 million primarily due to changes to revenue projections and the discount rate utilized .

Subsequent to the Spin-Off in the second quarter of 2024, in conjunction with a portfolio review, we determined to reduce investment in the development of the IPR&D asset, which impacted the amount and timing of expected future cash flows attributable to IPR&D which we concluded was a possible indicator of impairment

and another IPR&D impairment test was performed.

The impairment assessment resulted in an additional impairment charge of $112.0 million primarily due to a decrease in projected cash flows .

Other general and administrative costs increased by $1.4 million primarily due to increases in allocated expenses primarily due to changes in headcount resulting from the reduction in workforce related to the Restructuring Plan.

Interest Income

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

(in thousands) September 30,

2025 September 30,

Interest income $ 6,107 $ 11,661 $ (5,554) (48 %)

The increase in interest income of $4.0 million was primarily driven by an increase in interest earned on our money market funds and short-term marketable securities primarily due to an increase in the balance on hand as a result of the disposal funding provided by Illumina in connection with the Spin-Off.

The decrease in interest income of $5.6 million was primarily driven by a decrease in interest earned on our money market funds and short-term marketable securities primarily due to decreases in the average balance on hand and a decrease in interest yield.

Other Income (Expense)

Three Months Ended Change

(in thousands) September 30,

2025 September 30,

Other income (expense), net

$ 466 $ (561) $ 1,027 (183 %)

The increase in other income of $1.0 million was primarily a result of the fluctuation of foreign currency exchange rates.

Benefit from Income Taxes

Three Months Ended Change

(in thousands) June 30,

2025 June 30,

(in thousands) September 30,

2025 September 30,

Benefit from income taxes

$ 29,741 $ 46,719 $ (16,978) (36 %)

The decrease in benefit from income taxes of $14.3 million was primarily driven by the increase in effective tax rate for the three months ended June 30, 2025 when compared to the effective tax rate for the three months ended June 30, 2024.

The increase in effective tax rate for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 primarily relates to the Company’s 2024 valuation allowance impacts against pre-tax losses prior to the Spin-off.

Comparison of the Six Months Ended June 30, 2025 and June 30, 2024

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

The decrease in benefit from income taxes of $17.0 million was primarily driven by the decrease in the loss before income taxes for the three months ended September 30, 2025 when compared to the loss before income taxes for the three months ended September 30, 2024.

Comparison of the Nine Months Ended September 30, 2025 and September 30, 2024

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Screening revenue

4 unchanged sentences

Screening Revenue

The increase in screening revenue of $11.8 million was primarily attributable to a 30% increase in Galleri sales volume, offset by a 5% decrease in ASP.

The Galleri sales volume increased in the first six months of 2025 as a result of the continued ramp in our commercial activity and partnerships, expansion of our network of ordering providers, and new promotional campaigns.

The increase in screening revenue of $19.2 million was primarily attributable to a 33% increase in Galleri sales volume, partially offset by a 6% decrease in ASP.

The Galleri sales volume increased in the first nine months of 2025 as a result of the continued ramp in our commercial activity and partnerships, expansion of our network of ordering providers, and new promotional campaigns.

Development Services Revenue

The decrease in development services revenue of $3.1 million was primarily due to a decrease of $1.5 million in revenue from pilots with biopharmaceutical partners, a decrease of $0.6 million in revenue earned from research services, a decrease of $0.5 million in clinical development revenue, and a decrease of $0.5 million in other services revenue.

The decrease in development services revenue of $3.0 million was primarily due to a decrease of $1.9

million in revenue from pilots with biopharmaceutical partners, a decrease of $0.5 million in revenue earned from research services, and a decrease of $0.5 million in other services revenue.

Cost of Screening Revenue (Exclusive of Amortization of Intangible Assets)

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Cost of screening revenue (exclusive of amortization of intangible assets)

$ 52,379 $ 45,481 $ 6,898 15 %

The increase in cost of screening revenue (exclusive of amortization of intangible assets) of $7.0 million was primarily attributable to an increase in test volume.

Cost of screening revenue (exclusive of amortization of intangible assets) as a percent of revenue decreased in 2025 primarily due to the reduction in variable costs of Galleri testing performed on our automated platform;

however, this decrease was offset by the 5% decrease in ASP and increased sample re-processing costs.

The increase in cost of screening revenue (exclusive of amortization of intangible assets) of $6.9 million was primarily due to an increase in test volume.

Cost of screening revenue (exclusive of amortization of intangible assets) as a percent of screening revenue decreased 5% mainly due to the reduction in variable costs of Galleri testing performed on our automated platform, partially offset by a 6% decrease in ASP and higher sample reprocessing costs.

Cost of Development Services Revenue

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Cost of development services revenue

$ 2,216 $ 3,499 $ (1,283) (37 %)

The decrease in cost of development services revenue of $1.3 million was primarily attributable to a decrease in other services revenue and development services projects completed during the periods.

Research and Development

Research and development expenses for the six months ended June 30, 2025 and June 30, 2024 were as follows:

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Research and development expenses for the nine months ended September 30, 2025 and September 30, 2024 were as follows:

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Compensation expenses $ 78,125 $ 138,398 $ (60,273) (44 %)

6 unchanged sentences

$ 148,898 $ 274,052 $ (125,154) (46 %)

The decrease in research and development expenses by $95.6 million was primarily attributable to decreases in compensation expenses, laboratory supplies and research collaboration expenses, and clinical study expenses.

The decrease of $41.4 million in compensation expenses was primarily related to a decrease of $26.1 million in salaries and wages, a decrease of $13.3 million in stock-based compensation, and a decrease of $2.7 million in variable compensation expense primarily due to the reduction in workforce related to the Restructuring Plan, partially offset by an increase of $0.7 million in severance and benefits.

The decrease in laboratory supplies and research collaboration expenses of $20.3 million was primarily driven by the completion of the development and validation of our automated platform at the end of 2024 as well as the completion of enrollment in our PATHFINDER 2 study and completion of final study visits in our NHS-Galleri Trial.

The decrease in clinical studies of $19.0 million was primarily due to a decrease of $21.0 million primarily related to completion of enrollment in our PATHFINDER 2 study and completion of final study visits in our NHS-Galleri Trial, partially offset by an increase of $2.0 million due to enrollment in our REACH/Galleri-Medicare study.

The decrease of $9.0 million in allocated expenses was primarily attributable to lower software, IT, and facilities expenses being allocated to the research and development function.

The decrease in research and development expenses of $125.2 million was primarily attributable to decreases in compensation expenses, laboratory supplies and research collaboration expenses, clinical study expenses, allocated expenses, and other expenses.

The decrease of $60.3 million in compensation expenses was primarily related to a decrease of $34.8 million in salaries and wages, a decrease of $15.8 million in stock-based compensation, a decrease of $8.0 million in severance and benefits, and a decrease of $1.7 million in variable compensation expense primarily due to the reduction in workforce related to the Restructuring Plan.

The decrease in clinical studies of $19.3 million was primarily attributable to a decrease of $22.3 million primarily related to completion of enrollment in our PATHFINDER 2 study and completion of final study visits in our NHS-Galleri Trial, partially offset by an increase of $3.0 million due to enrollment in our REACH/Galleri-Medicare study.

The decrease of $10.2 million in allocated expenses was primarily attributable to ongoing cost reduction efforts, which resulted in lower software, IT, and facilities expenses being allocated to the research and development function, as well as reduced headcount.

The decrease in laboratory supplies and research collaboration expenses of $27.2 million was primarily driven by the substantial completion of the development and validation of our automated platform at the end of 2024 as well as the completion of enrollment in our PATHFINDER 2 study and completion of final study visits in our NHS-Galleri Trial.

The decrease of $7.4 million in other expenses was primarily driven by a decrease of $3.0 million in the use of contractors and temporary labor, a decrease of $2.2 million in professional services, and a decrease of $1.6 million in cloud computing expenses due to cost optimization efforts.

Sales and Marketing

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Sales and marketing $ 89,021 $ 123,433 (34,412) (28) %

The decrease in sales and marketing expenses of $24.3 million was primarily attributable to a decrease of $18.9 million in compensation expenses primarily related to a decrease in salaries and wages of $14.0 million and a decrease in stock-based compensation of $4.6 million primarily due to the reduction in workforce related to the Restructuring Plan.

The decrease in sales and marketing expenses of $34.4 million was primarily attributable to a decrease of $26.5 million in compensation expenses primarily related to a decrease in salaries and wages of $17.2 million, a decrease in severance and benefits of $4.8 million, and a decrease in stock-based compensation of $4.5 million primarily due to the reduction in workforce related to the Restructuring Plan.

Third-party marketing professional services expenses decreased by $6.5 million due to cost optimization efforts.

Other expenses decreased by $1.4 million primarily driven by decreases in the use of contractors and temporary labor as well as reductions in allocated expenses due to cost optimization efforts.

General and Administrative

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

General and administrative

$ 120,396 $ 171,745 $ (51,349) (30 %)

The decrease in general and administrative expenses of $41.3 million was primarily attributable to a decrease of $21.7 million in legal and professional services expenses due to no longer incurring legal and professional service fees related to compliance with the European Commission hold separate order and transaction costs related to our Spin-Off, which completed on June 24, 2024.

Compensation expenses decreased by $16.6 million primarily related to a decrease in salaries and wages of $8.2 million and a decrease of $7.0 million in stock-based compensation primarily due to the reduction in workforce related to the Restructuring Plan.

Other general and administrative costs decreased by $3.0 million primarily driven by decreases in the use of contractors and temporary labor due to cost optimization efforts.

The decrease in general and administrative expenses of $51.3 million was primarily attributable to decreases in legal and professional services expenses and compensation related expenses.

Legal and professional services expenses decreased by $24.1 million primarily due to no longer incurring legal and professional service fees related to compliance with the European Commission hold separate order and transaction costs related to our Spin-Off, completed on June 24, 2024.

Compensation expenses decreased by $23.4 million primarily related to a decrease in salaries and wages of $9.7 million, a decrease in stock-based compensation of $7.6 million, and a decrease in severance and benefits of $6.1 million primarily due to the reduction in workforce related to the Restructuring Plan.

Costs associated with the use of contractors and temporary labor decreased by $5.8 million due to cost optimization efforts.

Other general and administrative costs increased by $2.0 million primarily due to increases in allocated expenses primarily driven by changes in headcount resulting from the reduction in workforce related to the Restructuring Plan.

Goodwill and Intangible Impairment

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Goodwill and intangible impairment

$ 28,000 $ 1,420,936 $ (1,392,936) (98 %)

In the second quarter of 2025, we identified a change in market conditions in relation to our IPR&D asset which is in development, which represented a potential impairment indicator.

An impairment assessment was performed which resulted in an impairment charge of $28 million primarily due to a decrease in projected cash flows and a higher discount rate.

The impairment assessment resulted in an additional impairment charge of $112.0 million primarily due to a decrease in projected cash flows .

Goodwill and intangible impairment decreased $1.4 billion due to a goodwill impairment charge of $888.9 million resulting from the difference between the carrying value of our reporting unit and its fair value and an IPR&D impairment charge of $532 million resulting from the difference between the Company’s IPR&D carrying value and its estimated fair value, recognized during the second quarter of 2024, partially offset by an IPR&D impairment charge of $28 million resulting from the difference between the Company’s IPR&D carrying value and its estimated fair value recognized during the third quarter of 2025.

Interest Income

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Interest income

$ 20,695 $ 17,367 $ 3,328 19 %

The increase in interest income of $8.9 million was primarily driven by an increase in interest earned on our money market funds and short-term marketable securities primarily due to an increase in the balance on hand as a result of the disposal funding provided by Illumina in connection with the Spin-Off.

Other Income (Expense)

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Other income (expense), net

$ (1,395) $ 47 $ (1,442) (3068 %)

The decrease in other income of $1.4 million was primarily a result the fluctuation of foreign currency exchange rates.

The increase in interest income of $3.3 million was primarily driven by an increase in interest earned on our money market funds and short-term marketable securities primarily due to an increase in the average balance on hand.

Benefit from Income Taxes

Six Months Ended Change

(in thousands) June 30,

2025 June 30,

Nine Months Ended Change

(in thousands) September 30,

2025 September 30,

Benefit from income taxes

$ 108,811 $ 105,428 $ 3,383 3 %

The increase in benefit from income taxes of $20.4 million was primarily driven by the increase in effective tax rate for the six months ended June 30, 2025 when compared to the effective tax rate for the six months ended June 30, 2024.

The increase in effective tax rate 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.

The increase in benefit from income taxes of $3.4 million was primarily driven by the increase in effective tax rate for the nine months ended September 30, 2025 when compared to the effective tax rate for the nine months ended September 30, 2024.

The increase in effective tax rate 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.

Non-GAAP Financial Measures

In addition to our results provided throughout this Form 10-Q that are determined in accordance with GAAP, this Form 10-Q also includes the following non-GAAP financial measures for the three and six months ended June 30, 2025 and June 30, 2024, which information should be read in conjunction with our unaudited Condensed Consolidated Financial Statements and the related notes included elsewhere in this Form 10-Q:

In addition to our results provided throughout this Form 10-Q that are determined in accordance with GAAP, this Form 10-Q also includes the following non-GAAP financial measures for the three and nine months ended September 30, 2025 and September 30, 2024, which information should be read in conjunction with our unaudited Condensed Consolidated Financial Statements and the related notes included elsewhere in this Form 10-Q:

Adjusted Gross Profit/(Loss)

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The following table presents a reconciliation of gross loss, the most directly comparable financial measure calculated in accordance with GAAP, to Adjusted Gross Profit.

Three Months Ended Six Months Ended

(in thousands) June 30,

2025 June 30,

2024 June 30,

2025 June 30,

Three Months Ended Nine Months Ended

(in thousands) September 30,

2025 September 30,

2024 September 30,

2025 September 30,

Gross loss (1)

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GAAP, to Adjusted EBITDA on a consolidated basis.

Three Months Ended Six Months Ended

(in thousands) June 30,

2025 June 30,

2024 June 30,

2025 June 30,

Three Months Ended Nine Months Ended

(in thousands) September 30,

2025 September 30,

2024 September 30,

2025 September 30,

Net loss $ (88,977) $ (125,688) $ (309,175) $ (1,929,939)

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Restructuring (5)

— 19,007 (34) 19,007

Adjusted EBITDA $ (71,704) $ (108,156) $ (248,761) $ (399,516)

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On June 21, 2024, in connection with the Spin-Off we received a cash contribution of $932.3 million from Illumina.

As of June 30, 2025, our cash, cash equivalents and restricted cash totaled $130.8 million and our short-term marketable securities totaled $475.3 million.

As of September 30, 2025, our cash and cash equivalents totaled $126.9 million and our short-term marketable securities totaled $413.2 million.

On October 16, 2025, the Company entered into the Samsung Stock Purchase Agreement relating to the Samsung Investment, with expected aggregate gross proceeds of approximately $110.0 million.

We intend to use the net proceeds from the Samsung Investment to fund our commercial activities and reimbursement efforts, as well as for working capital and other general corporate purposes.

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.

We are subject to a number of obligations described in the Samsung Stock Purchase Agreement.

“Risk Factors”.

On October 21, 2025, we completed the Private Placement for aggregate gross proceeds of approximately $325.0 million, before deducting private placement expenses.

We intend to use the net proceeds from the Private Placement to fund our commercial activities and reimbursement efforts, as well as for working capital and other general corporate purposes.

Future Funding Requirements

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We expect to continue to incur operating losses over at least the next several years as we continue to invest in research and development and seek to achieve broad reimbursement of our current commercialized products.

We believe that our existing cash, cash equivalents and short-term marketable securities will be sufficient to meet our working capital and capital expenditure needs for at least the next 12 months, as of the date of this Form 10-Q.

However, we anticipate that we will need to raise additional financing in the future to fund our

Our future capital requirements will depend on many factors, including the timing and extent of spending to support commercialization, market acceptance of our products prior to broad reimbursement, the timing of broad reimbursement, and launch of pipeline products.

We believe that our existing cash, cash equivalents and short-term marketable securities will be sufficient to meet our working capital and capital expenditure needs into 2030, as of the date of this Form 10-Q.

However, we anticipate that we will need to raise additional financing in the future to fund our operations.

Our future capital requirements will depend on many factors, including the timing and extent of spending to support commercialization and pipeline product development, market acceptance of our products prior to broad reimbursement, and the timing of broad reimbursement.

We are subject to typical risks associated with an early-stage commercial company and are developing the market for multi-cancer early detection.

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The following table summarizes our cash flows for the periods presented:

Six Months Ended

(in thousands) June 30,

2025 June 30,

Nine Months Ended

(in thousands) September 30,

2025 September 30,

Net cash used in operating activities $ (235,222) $ (483,666)

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First quarter operating cash requirements are generally higher due to payment in the first quarter of our annual bonuses accrued during the prior year.

During the six months ended June 30, 2025 and June 30, 2024, cash paid for annual bonuses accrued during the prior year was $24.2 million and $25.9 million, respectively.

During the nine months ended September 30, 2025 and September 30,

2024, cash paid for annual bonuses accrued during the prior year was $24.2 million and $25.9 million, respectively.

Net Cash Used in Operating Activities

During the six months ended June 30, 2025, net cash used in operating activities consisted of a net loss of $220.2 million offset by non-cash charges of $47.5 million and cash provided by changes in our operating assets and liabilities of $0.8 million.

During the nine months ended September 30, 2025, net cash used in operating activities consisted of a net loss of $309.2 million offset by non-cash charges of $66.4 million and cash provided by changes in our operating assets and liabilities of $7.5 million.

The non-cash adjustments primarily consisted of depreciation and amortization of $117.4 million, stock-based compensation expense of $44.5 million, and intangible impairment expense of $28.0 million, which was partially offset by a non-cash benefit of $108.8 million relating to deferred taxes and amortization of discount on marketable securities of $16.6 million.

Changes in operating assets and liabilities was predominantly driven by a decrease in prepaids and other current assets of $4.8 million, a decrease in accounts receivable of $3.6 million, an increase in accounts payable of $1.4 million and a decrease in net operating lease assets and liabilities of $0.4 million, partially offset by a decrease in accrued and other liabilities of $8.5 million and an increase in supplies of $0.9 million.

During the six months ended June 30, 2024, net cash used in operating activities consisted of a net loss of $1.8 billion, $53.8 million cash payments for equity awards, and cash used by changes in our operating assets and liabilities of $18.8 million, partially offset by non-cash charges of $1.5 billion.

The non-cash adjustments primarily consisted of goodwill and intangible impairment expense of $1.4 billion, depreciation and amortization of $79.4 million and stock-based compensation expense of $55.1 million, which was partially offset by a non-cash

benefit of $57.9 million relating to deferred taxes.

Changes in operating assets and liabilities was predominantly driven by a decrease in accrued and other liabilities of $14.3 million, an increase in supplies of $3.8 million, a decrease in accounts payable of $3.3 million, and an increase in prepaids and other current assets of $2.5 million, partially offset by a decrease in accounts receivable of $3.5 million, and a decrease in net operating lease assets and liabilities of $1.6 million.

Changes in operating assets and liabilities was predominantly driven by a decrease in accounts receivable of $3.5 million, a decrease in prepaids and other current assets of $3.3 million, an increase in accrued and other liabilities of $0.9 million, a decrease in net operating lease assets and liabilities of $0.8 million, and a decrease in supplies of $0.5 million, partially offset by a decrease in accounts payable of $1.4 million.

During the nine months ended September 30, 2024, net cash used in operating activities consisted of a net loss of $1.9 billion, $53.8 million cash payments for equity awards, and cash used by changes in our operating assets and liabilities of $7.9 million, partially offset by non-cash charges of $1.5 billion.

The non-cash adjustments primarily consisted of goodwill and intangible impairment expense of $1.4 billion, depreciation and amortization of $118.6 million and stock-based compensation expense of $72.5 million, which was partially offset by a non-cash benefit of $105.0 million relating to deferred taxes.

Changes in operating assets and liabilities was predominantly driven by a decrease in accounts payable of $12.2 million, an increase in prepaids and other current assets of $1.3 million, partially offset by an increase in accrued and other liabilities of $1.8 million, a decrease in accounts receivable of $1.7 million, a decrease in net operating lease assets and liabilities of $1.5 million, and a decrease in supplies of $0.5 million.

Net Cash Provided by (Used in) Investing Activities

During the six months ended June 30, 2025, net cash provided by investing activities primarily consisted of proceeds from maturities of marketable securities of $587.9 million, partially offset by purchases of marketable securities of $502.5 million and $0.4 million for capital expenditures primarily related to purchases of machinery and equipment for use in our laboratories.

During the six months ended June 30, 2024, net cash used in investing activities primarily consisted of $3.9 million for capital expenditures primarily related to purchases of machinery and equipment for use in our laboratories.

During the nine months ended September 30, 2025, net cash provided by investing activities primarily consisted of proceeds from maturities of marketable securities of $894.4 million, partially offset by purchases of marketable securities of $741.9 million and $0.8 million for capital expenditures primarily related to purchases of machinery and equipment for use in our laboratories.

During the nine months ended September 30, 2024, net cash used in investing activities primarily consisted of $4.9 million for capital expenditures primarily related to purchases of machinery and equipment for use in our laboratories.

Net Cash Provided by Financing Activities

During the six months ended June 30, 2025, there was no cash provided by or used in financing activities.

During the six months ended June 30, 2024, net cash provided by financing activities primarily consisted of $1.2 billion in funding received from Illumina.

During the nine months ended September 30, 2025, there was no cash provided by or used in financing activities.

During the nine months ended September 30, 2024, net cash provided by financing activities primarily consisted of $1.2 billion in funding received from Illumina.

Material Cash Requirements

There have been no material changes to our material cash requirements from those disclosed in our 2024 Form 10-K.

Refer to Notes 8 and 9 to our Consolidated Financial Statements for a discussion of our operating lease obligations and purchase commitments, respectively.

With the exception of future cash requirements associated with our Sunnyvale, California lease, there have been no material changes to our material cash requirements from those disclosed in our 2024 Form 10-K.

The 11-year lease term for our Sunnyvale, California lease will commence on October 1, 2026.

We expect the lease commencement date for accounting purposes to be in the first half of 2026.

See Note 7 — Leases for more information regarding this lease.

The aggregate expected additional future payments under the Sunnyvale, California lease are $62.1 million, of which $0.5 million is payable within one year.

Refer to Notes 8 and 9 to our Consolidated Financial Statements of our 2024 Form 10-K for a discussion of our operating lease obligations and purchase commitments, respectively.

Critical Accounting Policies and Estimates

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Actual results may differ from these estimates under different assumptions or conditions.

During the six months ended June 30, 2025, there were no material changes to our critical accounting policies and estimates from those disclosed within the consolidated financial statements for the year ended December 31, 2024 included in our 2024 Form 10-K (filed on March 5, 2025), except as described below.

During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies and estimates from those disclosed within the consolidated financial statements for the year ended December 31, 2024 included in our 2024 Form 10-K, except as described below.

Stock- Based Compensation Expense - 2024 Employee Stock Purchase Plan

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The expected term represents the term from the first day of the offering period to the purchase date.

The expected dividend yield is determined to be 0% given that we have never declared or paid cash dividends on our common

stock and do not anticipate paying such cash dividends.

The expected dividend yield is determined to be 0% given that we have never declared or paid cash dividends on our common stock and do not anticipate paying such cash dividends.

The risk-free interest rate is based upon U.S.

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The estimates and assumptions used in our assessment represent a Level 3 measurement because they are supported by little or no market activity and reflect our own assumptions in measuring fair value.

For the indefinite-lived intangible assets impairment analysis performed during the quarter, the discount rate estimate was derived from the American Institute of Certified Public Accountants (“AICPA”) Accounting and Valuation Guide.

For the indefinite-lived intangible assets impairment analysis performed during the second quarter of 2025, the discount rate estimate was derived from the American Institute of Certified Public Accountants (“AICPA”) Accounting and Valuation Guide.

The assumptions used are inherently subject to uncertainty and we note that small changes in these assumptions could have a significant impact on the concluded value.

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We will remain an emerging growth company (“EGC”) until the earliest to occur of the following:

(i) the last day of the fiscal year in which our total annual gross revenues first meet or exceed at least $1.235 billion (as adjusted for inflation), (ii) the date on which we have, during the prior three-year period, issued more than $1.0 billion in non-convertible debt, (iii) the last day of the fiscal year in which we (a) have an aggregate worldwide market value of common stock held by non-affiliates of $700 million or more (measured at the end of each fiscal year) as of the last business day of our most recently completed second fiscal quarter and (b) have been a reporting company under the Exchange Act for at least one year (and have filed at least one annual report under the Exchange Act), or (iv) the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act.

As of June 30, 2025, the market value of our common stock that is held by non-affiliates exceeded $700.0 million;

therefore, as of December 31, 2025, we expect that we will cease to be an EGC.

(i) the last day of the fiscal year in which our total annual gross revenues first meet or exceed at least $1.235 billion (as adjusted for inflation), (ii) the date on which we have, during the prior three-year period, issued more than $1.0 billion in non-convertible debt, (iii) the last day of the fiscal year in which we (a) have an aggregate worldwide market value of common stock held by non-affiliates of $700 million or more (measured at the end of each fiscal year) as of the last business day of our most recently completed second fiscal quarter and (b) have been a reporting company under the Exchange Act for at least one year (and have filed at least one annual report under the Exchange Act and are not smaller reporting company), or (iv) the last day of the fiscal year following the fifth anniversary of the date of the first sale of our common stock pursuant to an effective registration statement under the Securities Act.

Recent Accounting Pronouncements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis