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 ___________________________________ ...

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.

GRAIL (GRAL) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0Good day, ladies and gentlemen, and welcome to the GRAIL Second Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.Speaker1Thanks, operator, and thanks, everyone, for joining us today. On the call are Bob Ragusa ...

NEWS RELEASE Exhibit 99.1 GRAIL Reports Second Quarter 2025 Financial Results 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. — August 12, 2025 — GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financia ...

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]

Summary of GRAIL (GRAL) 2025 Conference Call Company Overview - GRAIL is focused on early cancer detection, aiming to identify cancers when they are most treatable [2][3] - The company has developed the Gallery test, a multi-cancer early detection test designed for population-scale screening [3][4] Core Industry Insights - Current cancer screening methods are limited, primarily testing for single cancers, leading to late-stage cancer diagnoses [3][12] - GRAIL's Gallery test is positioned to address this gap by detecting multiple cancers early, significantly improving survival rates [12][13] Key Financial Highlights - Total revenue for Q1 2025 was $32 million, a 19% increase year-on-year [9] - U.S. Gallery revenue was $29 million, up 22%, aligning with the company's guidance for the year [9] - Cash balance stands at $678 million, providing operational runway into 2028 [10] Commercial Developments - Over 325,000 Gallery tests sold through March 2025, with strong commercial momentum noted [4][22] - Partnerships with Quest Diagnostics and Athena Health have been established to enhance provider access to the Gallery test [5][24] - The U.S. military's TRICARE program has added the Gallery test as a covered benefit for eligible patients [6] Clinical Evidence and Research - GRAIL has conducted over 640,000 Gallery tests across commercial and clinical applications [5] - The Gallery test has shown a positive predictive value (PPV) of 43%, significantly higher than leading single cancer screening tests [16][17] - The test's specificity is reported at 99.5%, with high accuracy in determining the cancer signal's origin [19] Market Opportunity - The total addressable market (TAM) in the U.S. is over 100 million individuals, expanding to 160 million when including the EU and nearly 50 million in Japan [21][22] - The company aims to capture a significant share of the market by providing broad access to multi-cancer early detection [26] Future Outlook - GRAIL is focused on obtaining FDA approval and broad reimbursement for the Gallery test, with significant investments in infrastructure and operations [6][10] - Upcoming milestones include the readout of foundational data from the Pathfinder study and final clinical utility data from the NHS Gallery study expected in mid-2026 [28] Additional Insights - Market research indicates a strong consumer desire for innovative cancer screening options, with a majority of adults wanting early detection [8] - The company is committed to reducing costs per test as it scales operations, which will enhance accessibility [10][26] - GRAIL's long-term vision includes expanding its capabilities to meet the needs of individuals at elevated risk of cancer [26][27]

Core Viewpoint - GRAIL, Inc. is focused on early cancer detection to improve treatment outcomes and will present at the Jefferies Global Healthcare Conference 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, and treatment monitoring [3] - The company is headquartered in Menlo Park, California, with additional locations in Washington, D.C., North Carolina, and the United Kingdom [3]

[Part I - Financial Information](index=4&type=section&id=Part%20I%20-%20Financial%20Information) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the quarter ended March 31, 2025, including detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2025, shows total assets of **$2.85 billion**, a decrease from **$2.98 billion** at December 31, 2024, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $133,895 | $214,234 | | Short-term marketable securities | $540,688 | $549,236 | | Total current assets | $727,655 | $819,861 | | Intangible assets, net | $1,982,306 | $2,016,890 | | **Total assets** | **$2,847,605** | **$2,983,307** | | **Liabilities & Equity** | | | | Total current liabilities | $74,977 | $76,925 | | **Total liabilities** | **$433,937** | **$479,902** | | **Total stockholders' equity** | **$2,413,668** | **$2,503,405** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Total revenue increased to **$31.8 million** in Q1 2025, while net loss significantly narrowed to **$106.2 million** due to reduced operating expenses Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total revenue | $31,837 | $26,721 | | Total costs and operating expenses | $185,444 | $254,143 | | Loss from operations | $(153,607) | $(227,422) | | Net loss | $(106,213) | $(218,914) | | Net loss per share — Basic and Diluted | $(3.10) | $(7.05) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved to **$95.0 million** in Q1 2025, with **$14.6 million** provided by investing activities Condensed Consolidated Statements of Cash Flow Highlights (in thousands) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(95,012) | $(207,286) | | Net cash provided by (used in) investing activities | $14,611 | $(2,548) | | Net cash provided by financing activities | $— | $312,000 | | Net (decrease) increase in cash | $(80,339) | $102,129 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section details the company's spin-off from Illumina, accounting policies, legal proceedings, and the impact of the 2024 restructuring plan - GRAIL separated from Illumina on June 24, 2024, becoming an independent public entity. Illumina retained a **14.5%** ownership stake post-spin-off, which has since reduced to **12.8%** as of March 31, 2025[33](index=33&type=chunk)[86](index=86&type=chunk) - The company believes its existing cash, cash equivalents, and short-term marketable securities are sufficient to meet its needs for at least the next 12 months[38](index=38&type=chunk) - An SEC inquiry related to Illumina's acquisition of GRAIL was closed on May 9, 2025[63](index=63&type=chunk) - The 2024 Restructuring Plan, designed to focus on the core MCED business, was substantially completed in Q4 2024, with total charges of **$18.3 million**. As of March 31, 2025, there was no remaining restructuring liability[72](index=72&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 financial performance, highlighting increased Galleri test volume, reduced operating expenses from restructuring, and liquidity - The company sold over **37,000** Galleri tests in Q1 2025, contributing to a total of over **325,000** commercial tests sold to date[95](index=95&type=chunk)[96](index=96&type=chunk) - A restructuring plan approved in August 2024 to focus on the core MCED business involved a headcount reduction of approximately **30%** and was substantially completed in Q4 2024[101](index=101&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) Q1 2025 vs Q1 2024 Operating Expense Changes (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $53,625 | $101,625 | $(48,000) | (47%) | | Sales and marketing | $34,979 | $46,819 | $(11,840) | (25%) | | General and administrative | $45,074 | $57,069 | $(11,995) | (21%) | Reconciliation of Net Loss to Adjusted EBITDA (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss | $(106,213) | $(218,914) | | Adjustments | $6,478 | $66,945 | | **Adjusted EBITDA** | **$(98,735)** | **$(151,969)** | - As of March 31, 2025, the company had **$137.2 million** in cash, cash equivalents, and restricted cash, and **$540.7 million** in short-term marketable securities. Management believes this is sufficient to fund operations for at least the next 12 months but anticipates needing to raise additional financing in the future[158](index=158&type=chunk)[159](index=159&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure is primarily from interest rate changes and foreign currency fluctuations, with no material impact expected - The company is exposed to interest rate risk on its cash, cash equivalents, and restricted cash of **$137.2 million** and short-term marketable securities of **$540.7 million** as of March 31, 2025[173](index=173&type=chunk) - Foreign currency risk is present due to transactions denominated in currencies other than the U.S. dollar, primarily the British pound[175](index=175&type=chunk) - A hypothetical **10%** relative change in interest rates or foreign exchange rates would not have had a material impact on the company's financial statements[174](index=174&type=chunk)[175](index=175&type=chunk) [Controls and Procedures](index=41&type=section&id=Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with no material changes to internal control over financial reporting - Based on an evaluation as of the end of the reporting period, the principal executive officer and principal financial officer concluded that disclosure controls and procedures were effective[177](index=177&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[178](index=178&type=chunk) [Part II - Other Information](index=42&type=section&id=Part%20II%20-%20Other%20Information) [Legal Proceedings](index=42&type=section&id=Legal%20Proceedings) This section details legal matters, including the closure of an SEC inquiry and ongoing securities class action lawsuits - For details on legal proceedings, the report refers to Note 7 of the condensed consolidated financial statements[179](index=179&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) Key risks include product performance, clinical trial outcomes, regulatory uncertainty for LDTs, and international operational challenges - A primary risk is that products may not perform as expected, and clinical study results may not support commercial use, regulatory approval, or reimbursement[182](index=182&type=chunk) - A U.S. District Court vacated the FDA's LDT Final Rule on March 31, 2025, creating significant uncertainty around the future regulation of LDTs like Galleri. If the rule is ultimately implemented, compliance would be costly and time-consuming[184](index=184&type=chunk)[202](index=202&type=chunk) - Preliminary or interim data from clinical trials, such as the NHS-Galleri trial, are subject to change and may differ materially from final results, which could harm business prospects[188](index=188&type=chunk)[190](index=190&type=chunk) - The company faces risks from international operations, including tariffs, trade restrictions, and varying political and regulatory environments, which could adversely impact results[193](index=193&type=chunk)[195](index=195&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported during the quarter - None[209](index=209&type=chunk) [Defaults Upon Senior Securities](index=49&type=section&id=Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported during the quarter - None[210](index=210&type=chunk) [Mine Safety Disclosures](index=49&type=section&id=Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[211](index=211&type=chunk) [Other Information](index=49&type=section&id=Other%20Information) Directors and officers adopted Rule 10b5-1 trading plans for future common stock sales during the quarter - On March 13, 2025, CFO Aaron Freidin, President Joshua Ofman, and Director Sarah Krevans each entered into a Rule 10b5-1 trading arrangement for the sale of common stock[213](index=213&type=chunk)[214](index=214&type=chunk)[215](index=215&type=chunk) [Exhibits](index=50&type=section&id=Exhibits) This section lists exhibits filed, including key agreements and required certifications - A list of exhibits filed with the report is provided, including key agreements and required certifications[218](index=218&type=chunk)

Financial Data and Key Metrics Changes - First quarter revenue reached $31.8 million, an increase of $5.1 million or 19% compared to the first quarter of 2024 [26] - Screening revenue was $29.1 million, up 24% year-over-year, while development service revenue was $2.7 million [27] - Net loss for the quarter was $106.2 million, an improvement of 51% compared to the same quarter last year [29] - Non-GAAP adjusted gross profit was $14.3 million, a 19% increase from the previous year [29] - Cash position at the end of the quarter was $677.9 million, with a projected cash burn of no more than $320 million for the full year 2025 [29][30] Business Line Data and Key Metrics Changes - The company sold over 37,000 Gallery tests in the first quarter, with repeat test volumes exceeding 20% [27][28] - The rollout of an enhanced version of the Gallery test began in Q4 of the previous year, aimed at improving scalability and reducing costs [9] Market Data and Key Metrics Changes - The company has prescribed over 325,000 Gallery tests since its commercial launch in 2021, with more than 14,000 healthcare providers involved [8] - The integration of Gallery within athenahealth's EHR platform is expected to streamline the ordering process for over 60,000 US providers [9] Company Strategy and Development Direction - The company aims to advance its Gallery test through key clinical and regulatory milestones to unlock broader access [5] - A new educational campaign called "Generation Possible" has been launched to raise public awareness about multi-cancer early detection [10] - The company is focused on maintaining disciplined cost management while pursuing commercial growth in 2025 [5][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for the Gallery test and the progress towards FDA approval and broad reimbursement [31] - The company is on track for continued commercial growth, with expected volume growth from TRICARE coverage and integration with Quest Diagnostics [9][31] - Management highlighted the importance of annual screening with the Gallery test to reduce the risk of late-stage cancer diagnosis [21] Other Important Information - The NHS Gallery trial is the largest randomized controlled trial of any multi-cancer early detection test, with results expected in mid-2026 [14][15] - The company plans to submit data from the NHS Gallery trial and other studies as part of its premarket approval application in the first half of 2026 [25] Q&A Session Summary Question: Can you quantify the short-term variable cost improvements from the new version of Gallery? - Management indicated that margins are expected to improve over the year as the transition to the new version is completed [35] Question: How have Quest and TRICARE approvals played out in Q1? - Management noted early positive ordering trends from Quest providers and ongoing work with TRICARE contractors [36][37] Question: What is the cash burn trajectory for the remainder of the year? - The company reported a cash burn of just under $90 million in Q1, with expectations to remain within the $320 million target for the year [42][43] Question: How does the NHS Gallery data impact future readouts? - Management emphasized that the first round of screening results may differ from subsequent rounds, with final results expected in mid-2026 [50] Question: What is the rationale behind not raising additional funds at this time? - Management believes that achieving key milestones will derisk the business and create value, thus justifying the decision to wait [61][62]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $31.8 million, an increase of $5.1 million or 19% compared to Q1 2024 [26] - Screening revenue was $29.1 million, up 24% year-over-year, while development service revenue was $2.7 million [27] - Net loss for the quarter was $106.2 million, an improvement of 51% compared to Q1 2024 [29] - Non-GAAP adjusted gross profit for Q1 2025 was $14.3 million, an increase of $2.3 million or 19% year-over-year [29] - Cash position at the end of the quarter was $677.9 million, with a projected cash burn of no more than $320 million for the full year 2025 [29][30] Business Line Data and Key Metrics Changes - More than 37,000 Gallery tests were sold in Q1 2025, with repeat test volumes increasing over time, now accounting for over 20% of total volume [26][27] - The company has prescribed over 325,000 Gallery tests since its commercial launch in 2021 [7] Market Data and Key Metrics Changes - The company has launched Gallery commercially in Israel in partnership with OncoTest, with initial test orders being received [9] - The integration of Gallery within athenahealth's EHR platform is expected to streamline the ordering process for over 60,000 US providers [8] Company Strategy and Development Direction - The company aims to advance Gallery through key clinical and regulatory milestones to unlock broad access while managing costs [5] - A new educational campaign called "Generation Possible" has been initiated to raise public awareness of multi-cancer early detection [9] - The company is focused on achieving FDA approval for Gallery and pursuing broad reimbursement [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for Gallery and the progress towards major milestones, including TRICARE coverage and integration with Quest Diagnostics [31] - The company expects to share interim data from the PATHFINDER II study in late 2025 and complete its PMA submission to the FDA in the first half of 2026 [31] Other Important Information - The NHS Gallery trial is the largest randomized controlled trial of any multi-cancer early detection test, with results expected in mid-2026 [12][14] - The company has made significant investments to optimize technology and laboratory infrastructure, including the rollout of an enhanced version of the Gallery test [7] Q&A Session Summary Question: Can you quantify the expected short-term variable cost improvements from the new version of Gallery? - Management indicated that margins are expected to improve over the year as they transition to the new version [35][36] Question: How is the cash burn tracking towards the $320 million target? - The company burned just under $90 million in Q1, with expectations that cash burn will align with the target as margins improve [42][44] Question: What is the rationale behind not raising money to derisk the outlook? - Management believes that achieving major milestones will create value and that they have sufficient cash runway to reach these goals [62][66] Question: How are recent conversations with NHS progressing regarding Gallery commercialization? - Management stated they are in constant dialogue with NHS and that decisions on commercialization will wait for final results from the study [70][72]