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]

Core Insights - GRAIL, Inc. reported a 21% year-over-year growth in U.S. Galleri revenue, reaching $34.2 million in Q2 2025, with total revenue increasing by 11% to $35.5 million [2][8] - The company sold over 45,000 Galleri tests in Q2 2025, marking a 29% increase year-over-year [1][2] - GRAIL plans to present detailed results from the PATHFINDER 2 study at the ESMO 2025 conference in October, following promising top-line performance and safety results [1][2] Financial Performance - Total revenue for Q2 2025 was $35.5 million, an increase of $3.6 million or 11% compared to Q2 2024 [2][8] - Galleri revenue specifically grew by 22% year-over-year to $34.4 million [2] - The net loss for the quarter was $114.0 million, which included a $28.0 million impairment related to the Illumina acquisition [2][8] - Adjusted gross profit was $16.1 million, reflecting a slight increase of 1% year-over-year [8][22] - Adjusted EBITDA for the quarter was $(78.3) million, showing an improvement of $61.1 million or 44% compared to the previous year [8][22] Business Highlights - GRAIL's Galleri test is designed for early cancer detection through a simple blood draw, identifying DNA shed by cancer cells [7][9] - The company has entered a collaboration with Everlywell to expand access to the Galleri test, which is now available via prescription on their platform [8] - Rush University System for Health has become the first health system in the Chicago area to offer the Galleri test [8] - Positive results from the PATHFINDER 2 study indicated a significantly higher positive predictive value (PPV) compared to previous studies, with no serious safety concerns reported [8][19] Market Position and Strategy - GRAIL focuses on using next-generation sequencing and machine learning to detect multiple cancer types at earlier stages, aiming to alleviate the global burden of cancer [5][7] - The company is actively driving provider and patient awareness of the multi-cancer early detection (MCED) opportunity [2][8] - GRAIL's cash position as of June 30, 2025, was $606.1 million, providing a solid foundation for ongoing operations and growth initiatives [8][18]

[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]

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]