Core Viewpoint - GRAIL, Inc. is focused on early cancer detection to improve treatment outcomes and will present at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025 [1]. Company Overview - GRAIL is a healthcare company dedicated to detecting cancer early when it is most treatable [3]. - The company utilizes next-generation sequencing, large-scale clinical studies, and advanced machine learning to identify multiple cancer types at earlier stages [3]. - GRAIL's platform supports various aspects of cancer care, including multi-cancer early detection, risk stratification, minimal residual disease detection, biomarker subtyping, and monitoring treatment and recurrence [3]. - The company is headquartered in Menlo Park, California, with additional locations in Washington, D.C., North Carolina, and the United Kingdom [3].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-42045 ___________________________________ ...

Group 1 - Grail updates its 2025 cash burn guidance to $310 million, primarily due to increased adoption of its Galleri testing product and expansion of partnerships [1] - The company reports a 93% year-over-year improvement in net loss, attributed to the growth in testing orders [1]

Summary of GRAIL (GRAL) FY Conference Call - August 13, 2025 Company Overview - GRAIL is a company focused on early cancer detection through its multi-cancer early detection (MCED) test, known as the Gallery test [2][3]. Key Financial Highlights - In Q2, GRAIL reported strong demand for its Gallery tests, with U.S. Gallery revenue growing over 20% to $34 million [3][4]. - The number of tests performed increased to 45,000, representing a 29% growth [4]. - The company reiterated its guidance for U.S. Gallery commercial growth of 20% to 30% [4]. - Cash burn was reduced from $320 million to $310 million due to effective restructuring efforts [5]. Product Development and Studies - GRAIL is preparing to present detailed data from its Pathfinder two study at the ESMO conference in October [5]. - The company reported improved positive predictive value (PPV) and cancer detection rates compared to previous studies [6]. - Both Pathfinder two and NHS Gallery studies are expected to provide data for filing a premarket approval (PMA) [7]. Testing and Market Dynamics - The average selling price (ASP) per test was approximately $8,800, slightly lower due to increased repeat testing rates, which rose to 25% from 20% [9][10]. - The cost of goods sold (COGS) per test decreased due to the rollout of the Gallery 2.0, which aimed to automate and optimize the testing process [11][12]. - GRAIL's focus remains on the Gallery test, with limited expansion in biopharma revenue streams due to restructuring [16][17]. Competitive Landscape - GRAIL acknowledges the competitive environment but views it positively, as it raises awareness and support for MCED tests [38][39]. - The company is preparing for the launch of a competitor's MCED test but believes its own test has a significantly lower false positive rate and better cancer signal of origin [37][38]. Regulatory and Legislative Outlook - GRAIL is optimistic about the passage of the Nancy Sue bill, which aims to improve Medicare coverage for cancer screening [49][50]. - The company is actively lobbying for this legislation, which has garnered bipartisan support [50]. - GRAIL anticipates that FDA approval and inclusion in USPSTF guidelines will be critical for broader adoption and reimbursement [53][54]. Future Milestones - Key upcoming milestones include the readout of Pathfinder two and NHS Gallery data, expected in mid-next year [26][27]. - GRAIL is confident in its funding, stating it is funded into 2028, which allows it to focus on upcoming milestones without immediate capital raising needs [65]. Conclusion - GRAIL is currently detecting significant numbers of asymptomatic cancers, emphasizing the real-time impact of its testing capabilities [67][68]. - The company remains focused on its core Gallery test while navigating the competitive landscape and preparing for regulatory approvals.

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $35.5 million, an increase of $3.5 million or 11% compared to Q2 2024 [22] - Screening revenue was $34.4 million, up 22% compared to the same period in 2024 [24] - Net loss for the quarter was $114 million, an improvement of 93% compared to Q2 2024 [26] - Non-GAAP adjusted gross profit for Q2 2025 was $16.1 million, an increase of $100,000 or 1% compared to Q2 2024 [26] - Cash position at the end of the quarter was $606.1 million, with updated guidance for cash burn in 2025 reduced to no more than $310 million [26] Business Line Data and Key Metrics Changes - More than 45,000 Gallery tests were sold in Q2 2025, with over 370,000 tests prescribed since the commercial launch in 2021 [7][22] - U.S. Gallery revenue was $34.2 million, up 21% compared to Q2 2024, with expectations of 20% to 30% growth for the full year [24][25] - Repeat test volumes have trended higher, with over 25% of Gallery's volume being repeat testing [23] Market Data and Key Metrics Changes - The company has established partnerships with healthcare systems, including Rush University System for Health, to increase availability of the Gallery test [7] - Integration of Gallery into the Quest diagnostic test ordering platform has shown promising growth, with 7% of orders coming through this platform in Q2 [61] Company Strategy and Development Direction - The company is focused on seeking FDA approval for Gallery and pursuing broad reimbursement [28] - Plans to submit detailed results from the Pathfinder two study for presentation at the ESMO Congress in October 2025 [28] - The company aims to achieve major clinical and regulatory milestones, with cash runway extending into 2028 [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for Gallery, both from new and returning patients [28] - The company is encouraged by the performance metrics from the Pathfinder studies, indicating improved cancer detection rates and positive predictive values [14][17] - Management highlighted the importance of clinical validation in the intended use population for the success of multi-cancer early detection tests [12][42] Other Important Information - The company is working to address increased turnaround times and higher reprocessing costs associated with the new version of Gallery [9] - The upcoming Analyst Day in November 2025 will feature key study results and clinical findings [9][28] Q&A Session Summary Question: Can you comment on Q2 free cash burn and dynamics impacting cash burn in the second half of 2025? - Management indicated that cash burn for the first half was about $160 million and expects it to decrease in the second half due to increased revenue and volume [34][35] Question: Do you need full longitudinal clinical utility data for PMA submission? - Management clarified that the FDA focuses on clinical validation rather than clinical utility for approvals [41][42] Question: How is the integration with Quest performing? - Management reported that about 500 healthcare professionals have ordered the Gallery test via Quest, with a 7% order rate through this platform in Q2 [61] Question: What are the expectations for repeat testing rates? - Management expressed satisfaction with the increase in repeat testing rates, which rose to over 25% in Q2 [65]

Q2 U.S. Galleri Revenue Grew 21% Year-Over-Year to $34.2 Million Q2 Galleri Tests Sold Grew 29% Year-Over-Year to More Than 45,000 Detailed Results From First 25,000 Enrolled in PATHFINDER 2 to be Submitted for Presentation at ESMO 2025 in October MENLO PARK, Calif., Aug. 12, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the second quarter 2025. Total revenue in the second ...

[Q2 2025 Financial and Business Highlights](index=1&type=section&id=I.%20Executive%20Summary%20%26%20Q2%202025%20Performance) GRAIL reported strong Q2 2025 financial improvements with increased revenue and a significantly reduced net loss, alongside key operational advancements in Galleri test adoption and positive clinical study results [Q2 2025 Financial Performance](index=1&type=section&id=I.A.%20Q2%202025%20Financial%20Performance) GRAIL reported an 11% year-over-year increase in total revenue to $35.5 million for Q2 2025, with U.S. Galleri revenue growing 21% to $34.2 million. The net loss significantly improved by 93% to $114.0 million, largely due to lower impairment charges compared to the prior year | Metric | Q2 2025 (Millions) | YoY Change | | :-------------------------------- | :------------------ | :--------- | | Total Revenue | $35.5 | +11% | | Galleri Revenue | $34.4 | +22% | | U.S. Galleri Revenue | $34.2 | +21% | | Net Loss | $(114.0) | +93% (Improvement) | | Gross Loss | $(17.8) | +1% (Improvement) | | Non-GAAP Adjusted Gross Profit | $16.1 | +1% (Increase) | | Non-GAAP Adjusted EBITDA | $(78.3) | +44% (Improvement) | - Cash, cash equivalents, restricted cash, and short-term marketable securities totaled **$606.1 million** as of June 30, 2025[3](index=3&type=chunk) [Q2 2025 Operational Highlights](index=1&type=section&id=I.B.%20Q2%202025%20Operational%20Highlights) GRAIL achieved significant operational milestones in Q2 2025, including a 29% year-over-year increase in Galleri tests sold to over 45,000. Positive top-line results from the PATHFINDER 2 study were announced, showing substantially greater additional cancer detection and higher positive predictive value compared to the first PATHFINDER study. The company also expanded access to Galleri through a new collaboration with Everlywell and adoption by Rush University System for Health - Galleri tests sold grew **29% year-over-year** to more than **45,000** in Q2 2025[1](index=1&type=chunk)[2](index=2&type=chunk) - Positive top-line performance and safety results from the PATHFINDER 2 study (first 25,578 participants) were announced in June, demonstrating substantially greater additional cancer detection and a higher positive predictive value (PPV) than the first PATHFINDER study. Specificity and cancer signal origin (CSO) accuracy were consistent with previous findings (**99.5%** and **88%**, respectively), with no serious safety concerns[2](index=2&type=chunk)[8](index=8&type=chunk) - Detailed results from the first 25,000 enrolled in PATHFINDER 2 are planned for submission for presentation at ESMO 2025 in October[1](index=1&type=chunk)[2](index=2&type=chunk) - Entered a new collaboration with Everlywell to expand access to the Galleri test, making it available for request directly on everlywell.com via prescription[8](index=8&type=chunk) - Rush University System for Health became the first health system in the Chicago-area market to offer the Galleri test in July[8](index=8&type=chunk) - Data presented at ASCO Annual Meeting in May included a 5-year follow-up analysis of the Circulating Cell-free Genome Atlas (CCGA) study, showing Galleri's preferential detection of aggressive, clinically meaningful cancers[8](index=8&type=chunk) [Company and Product Information](index=2&type=section&id=II.%20Company%20and%20Product%20Information) This section details GRAIL's mission in early cancer detection, the functionality and intended use of its Galleri multi-cancer early detection test, and its laboratory's regulatory certifications [About GRAIL](index=2&type=section&id=II.A.%20About%20GRAIL) GRAIL is a healthcare company dedicated to early cancer detection, leveraging next-generation sequencing, large-scale clinical studies, and advanced machine learning to identify multiple cancer types at earlier, more treatable stages - GRAIL's mission is to detect cancer early when it can be cured[1](index=1&type=chunk)[6](index=6&type=chunk) - The company uses next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation[6](index=6&type=chunk) - GRAIL's targeted methylation-based platform supports multi-cancer early detection, risk stratification, minimal residual disease detection, biomarker subtyping, and treatment/recurrence monitoring[6](index=6&type=chunk) [About Galleri® Test](index=3&type=section&id=II.B.%20About%20Galleri%C2%AE%20Test) The Galleri multi-cancer early detection test is a proactive blood-based screening tool that identifies DNA shed by cancer cells, helping to detect cancers that currently lack recommended screenings. It is intended for adults aged 50 or older with an elevated risk for cancer and should be used in conjunction with standard screenings - The Galleri test is a multi-cancer early detection test that uses a simple blood draw to identify DNA shed by cancer cells[9](index=9&type=chunk) - It helps screen for deadly cancers without recommended screenings, such as pancreatic, esophageal, ovarian, and liver cancers[9](index=9&type=chunk) - The test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older, and should be used in addition to recommended cancer screenings[9](index=9&type=chunk) [Laboratory and Regulatory Information](index=3&type=section&id=II.C.%20Laboratory%20and%20Regulatory%20Information) GRAIL's clinical laboratory is certified under CLIA and accredited by the College of American Pathologists. While the Galleri test was developed by GRAIL for clinical purposes, it has not received clearance or approval from the U.S. Food and Drug Administration - GRAIL's clinical laboratory is certified under CLIA (Clinical Laboratory Improvement Amendments of 1988) and accredited by the College of American Pathologists[11](index=11&type=chunk) - The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration[11](index=11&type=chunk) - The Galleri test is intended for clinical purposes and is regulated under CLIA for high-complexity testing[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=III.%20Financial%20Statements) This section provides GRAIL's condensed consolidated balance sheets and statements of operations, highlighting asset and liability changes and detailed revenue and expense figures for Q2 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=III.A.%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, GRAIL reported total assets of **$2.70 billion**, a decrease from **$2.98 billion** at December 31, 2024. This change was primarily driven by a reduction in cash and cash equivalents and short-term marketable securities | Asset/Liability/Equity (Thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | **Assets:** | | | | Cash and cash equivalents | $127,427 | $214,234 | | Short-term marketable securities | $475,327 | $549,236 | | Total current assets | $651,844 | $819,861 | | Intangible assets, net | $1,919,723 | $2,016,890 | | Total assets | $2,702,551 | $2,983,307 | | **Liabilities:** | | | | Total current liabilities | $70,639 | $76,925 | | Total liabilities | $387,908 | $479,902 | | **Stockholders'/Member's Equity:** | | | | Accumulated deficit | $(10,023,528) | $(9,803,330) | | Total stockholders'/member's equity | $2,314,643 | $2,503,405 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=III.B.%20Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, GRAIL's total revenue increased to **$35.5 million** from **$32.0 million** in the prior year. The net loss significantly narrowed to **$114.0 million**, a substantial improvement from **$1.59 billion** in Q2 2024, primarily due to a much lower goodwill and intangible assets impairment charge | Metric (Thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Screening revenue | $34,379 | $28,163 | $63,512 | $51,702 | | Development services revenue | $1,165 | $3,807 | $3,869 | $6,989 | | Total revenue | $35,544 | $31,970 | $67,381 | $58,691 | | Cost of screening revenue | $19,346 | $15,789 | $36,469 | $29,511 | | Cost of development services revenue | $501 | $621 | $1,672 | $2,057 | | Cost of revenue — amortization of intangible assets | $33,472 | $33,472 | $66,944 | $66,944 | | Research and development | $46,626 | $94,196 | $100,251 | $195,821 | | Sales and marketing | $28,539 | $40,989 | $63,518 | $87,808 | | General and administrative | $37,914 | $67,258 | $82,988 | $124,327 | | Goodwill and intangible assets impairment | $28,000 | $1,420,936 | $28,000 | $1,420,936 | | Total costs and operating expenses | $194,398 | $1,673,261 | $379,842 | $1,927,404 | | Loss from operations | $(158,854) | $(1,641,291) | $(312,461) | $(1,868,713) | | Net loss | $(113,985) | $(1,585,337) | $(220,198) | $(1,804,251) | | Net loss per share — Basic and Diluted | $(3.18) | $(51.06) | $(6.28) | $(58.11) | [Non-GAAP Financial Measures Reconciliation](index=3&type=section&id=IV.%20Non-GAAP%20Financial%20Measures%20Reconciliation) This section explains GRAIL's use of non-GAAP financial measures, Adjusted Gross Profit and Adjusted EBITDA, and provides detailed reconciliations to their most directly comparable GAAP measures [Non-GAAP Disclosure](index=3&type=section&id=IV.A.%20Non-GAAP%20Disclosure) GRAIL uses non-GAAP financial measures, Adjusted Gross Profit (Loss) and Adjusted EBITDA, to provide investors with a clearer view of its operational and financial performance by excluding certain non-recurring or non-cash items, such as amortization of intangible assets and acquisition-related costs - Adjusted Gross Profit (Loss) is used to assess operational performance, reflecting gross profitability by excluding amortization of intangible assets and stock-based compensation allocated to cost of revenue[12](index=12&type=chunk) - Adjusted EBITDA is used to assess financial performance and for internal planning, providing a comparable overview across historical periods by excluding interest, taxes, depreciation, impairment, acquisition-related legal fees, restructuring charges, and stock-based compensation[12](index=12&type=chunk)[13](index=13&type=chunk) [Adjusted Gross Profit Reconciliation](index=8&type=section&id=IV.B.%20Adjusted%20Gross%20Profit%20Reconciliation) For Q2 2025, Adjusted Gross Profit was **$16.1 million**, a slight increase from **$16.0 million** in Q2 2024. This was calculated by adjusting the GAAP gross loss of **$(17.8) million** by adding back amortization of intangible assets and stock-based compensation | Metric (Thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Gross loss | $(17,775) | $(17,912) | $(37,704) | $(39,821) | | Amortization of intangible assets | $33,472 | $33,472 | $66,944 | $66,944 | | Stock-based compensation | $417 | $463 | $1,179 | $944 | | Adjusted Gross Profit | $16,114 | $16,023 | $30,419 | $28,067 | [Adjusted EBITDA Reconciliation](index=9&type=section&id=IV.C.%20Adjusted%20EBITDA%20Reconciliation) GRAIL's Adjusted EBITDA for Q2 2025 was **$(78.3) million**, a significant improvement from **$(139.4) million** in Q2 2024. This improvement is largely attributed to the substantial reduction in goodwill and intangible impairment charges compared to the prior year | Metric (Thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(113,985) | $(1,585,337) | $(220,198) | $(1,804,251) | | Interest income | $(6,809) | $(2,805) | $(14,588) | $(5,706) | | Benefit from income tax expense | $(38,871) | $(53,144) | $(79,070) | $(58,709) | | Amortization of intangible assets | $34,583 | $34,583 | $69,167 | $69,167 | | Depreciation | $4,592 | $4,805 | $9,287 | $10,218 | | Goodwill and intangible impairment | $28,000 | $1,420,936 | $28,000 | $1,420,936 | | Illumina/GRAIL merger & divestiture legal and professional services costs | — | $15,624 | — | $21,932 | | Stock-based compensation | $14,168 | $25,947 | $30,379 | $55,053 | | Restructuring | — | — | $(34) | — | | Adjusted EBITDA | $(78,322) | $(139,391) | $(177,057) | $(291,360) | [Additional Information](index=2&type=section&id=V.%20Additional%20Information) This section provides details on GRAIL's Q2 2025 conference call, important disclaimers regarding forward-looking statements, and contact information for corporate communications and investor relations [Conference Call and Webcast](index=2&type=section&id=V.A.%20Conference%20Call%20and%20Webcast) GRAIL hosted a conference call and webcast on August 12, 2025, to discuss its Q2 2025 financial results, with a replay available on its investor relations website for 30 days - A webcast and conference call were held on August 12, 2025, at 1:30 p.m. PT / 4:30 p.m. ET[4](index=4&type=chunk) - Access to the conference call and webcast replay is available on the investor relations section of GRAIL's website (investors.grail.com)[4](index=4&type=chunk)[5](index=5&type=chunk) [Forward-Looking Statements](index=5&type=section&id=V.B.%20Forward-Looking%20Statements) The press release contains forward-looking statements subject to various risks, uncertainties, and assumptions, including future financial performance, product development, and regulatory compliance. Readers are cautioned that actual results may differ materially, and GRAIL undertakes no obligation to update these statements - Statements are forward-looking and subject to risks, uncertainties, and assumptions, including future financial performance, tests, patient awareness, clinical studies, and regulatory compliance[15](index=15&type=chunk) - Important factors could cause actual results to differ materially and adversely from those expressed, as discussed in the 'Risk Factors' sections of the Annual Report on Form 10-K and Quarterly Report on Form 10-Q[16](index=16&type=chunk) - GRAIL undertakes no obligation to update any forward-looking statements after the date of the press release, except as required by law[17](index=17&type=chunk) [GRAIL Contacts](index=5&type=section&id=V.C.%20GRAIL%20Contacts) Contact information for GRAIL's corporate communications and investor relations teams is provided for inquiries - Corporate Communications contacts are Kristen Davis and Trish Rowland (pr@grail.com)[18](index=18&type=chunk) - Investor Relations contacts are Alex Dobbin and Alexis Tosti (ir@grail.com)[18](index=18&type=chunk)

Company Overview - GRAIL, Inc. is a healthcare company focused on early cancer detection when it can be cured [3] - The company utilizes next-generation sequencing, population-scale clinical studies, and advanced machine learning to identify multiple cancer types at earlier stages [3] - GRAIL's platform supports various aspects of cancer care, including multi-cancer early detection, risk stratification, and treatment monitoring [3] Upcoming Event - GRAIL management will present at the Canaccord Genuity 45th Annual Growth Conference in Boston on August 13 at 8:30 a.m. ET [1] - Live and replay webcasts of the presentation will be available on GRAIL's investor relations website for at least 30 days [2]

Core Insights - GRAIL, Inc. is set to release its financial results for the second quarter of 2025 on August 12, 2025, after market close [1] - Following the financial results announcement, GRAIL management will conduct a webcast and conference call to discuss the results and business progress [1] Company Overview - GRAIL is a healthcare company focused on early cancer detection, aiming to alleviate the global burden of cancer through advanced technologies [4] - The company utilizes next-generation sequencing, population-scale clinical studies, and machine learning to identify multiple cancer types at earlier stages [4] - GRAIL's platform supports various aspects of cancer care, including multi-cancer early detection, risk stratification, and treatment monitoring [4] - The company is headquartered in Menlo Park, California, with additional locations in Washington, D.C., North Carolina, and the United Kingdom [4]

Core Insights - GRAIL, Inc. announced positive top-line performance and safety results from the PATHFINDER 2 study, which involved 25,578 participants and aimed to evaluate the Galleri multi-cancer early detection test [1][5] Group 1: Study Results - The PATHFINDER 2 study demonstrated that adding Galleri to standard cancer screening significantly increased cancer detection rates compared to the previous PATHFINDER study [2] - In the PATHFINDER study, Galleri had a positive predictive value (PPV) of 43%, specificity of 99.5%, and cancer signal origin (CSO) accuracy of 88%. The PATHFINDER 2 study showed a substantially higher PPV while maintaining consistent CSO accuracy and specificity [3] Group 2: Safety and Regulatory Aspects - No serious safety concerns were reported in the PATHFINDER 2 study, indicating a favorable safety profile for the Galleri test [4] - GRAIL plans to submit the PATHFINDER 2 study results to the U.S. FDA as part of the Galleri premarket approval application, which is currently in process under a Breakthrough Device Designation [5][6] Group 3: Future Directions - Detailed results from the PATHFINDER 2 study are expected to be presented at a leading international oncology meeting later this year [6] - The study aims to evaluate the Galleri test's performance across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy [7]