[Financial Performance](index=1&type=section&id=Financial%20Performance) GRAIL reported **$31.8 million** in total revenue for Q1 2025, a **19% year-over-year increase**, with net loss significantly improving to **$106.2 million** and adjusted EBITDA improving by **35%** Key Financial Metrics | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenue | $31.8 million | $26.7 million | +19% | | Galleri Revenue | $29.1 million | $23.5 million | +24% | | U.S. Galleri Revenue | $28.7 million | - | +22% | | Net Loss | $(106.2) million | $(218.9) million | +51% Improvement | | Adjusted EBITDA | $(98.7) million | $(152.0) million | +35% Improvement | | Gross Loss | $(19.9) million | $(21.9) million | +9% Improvement | - The company's cash, cash equivalents, restricted cash, and short-term marketable securities totaled **$677.9 million** as of March 31, 2025, which is expected to provide a financial runway into 2028[1](index=1&type=chunk)[4](index=4&type=chunk) - Over **37,000** Galleri tests were completed in the first quarter of 2025[3](index=3&type=chunk) [Clinical and Business Updates](index=2&type=section&id=Clinical%20and%20Business%20Updates) GRAIL announced positive top-line results from the NHS-Galleri trial, showing a higher Positive Predictive Value (PPV) than the PATHFINDER study, alongside new partnerships and educational initiatives - Positive top-line results from the NHS-Galleri trial's prevalent screening round showed a substantially higher Positive Predictive Value (PPV) than the PATHFINDER study, with consistent Cancer Signal of Origin (CSO) accuracy (**88%**) and specificity (**99.5%**)[1](index=1&type=chunk)[7](index=7&type=chunk) - Future data releases are planned, with registrational data from the PATHFINDER 2 study expected later in 2025 and final results from the three-year NHS-Galleri trial anticipated in mid-2026[8](index=8&type=chunk) - Recent business developments include: - Presentation of real-world data from **100,000** patients at AACR 2025, confirming Galleri's performance - A partnership with athenahealth to integrate Galleri test ordering into its EHR platform, reaching over **160,000** U.S. providers - Launch of the 'Generation Possible' educational campaign with actress Kate Walsh[9](index=9&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The unaudited condensed consolidated financial statements detail the company's financial position and operational results, showing a decrease in total assets and liabilities, alongside a significant reduction in net loss [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, GRAIL's total assets were **$2.85 billion**, with total liabilities decreasing to **$433.9 million**, and total stockholders' equity at **$2.41 billion** Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Item (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $133,895 | $214,234 | | Total current assets | $727,655 | $819,861 | | Total assets | $2,847,605 | $2,983,307 | | 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=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q1 2025, GRAIL generated **$31.8 million** in total revenue, significantly reducing its loss from operations to **$153.6 million** and improving net loss to **$106.2 million** Condensed Consolidated Statements of Operations (in thousands) | Statement of Operations (in thousands) | 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) | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=4&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) GRAIL provides non-GAAP measures like Adjusted Gross Profit and Adjusted EBITDA to clarify operational performance, with Q1 2025 Adjusted Gross Profit at **$14.3 million** and Adjusted EBITDA at **$(98.7) million** Reconciliation to Adjusted Gross Profit (in thousands) | Reconciliation to Adjusted Gross Profit (in thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Gross loss (GAAP) | $(19,929) | $(21,909) | | Amortization of intangible assets | $33,472 | $33,472 | | Stock-based compensation | $762 | $481 | | **Adjusted Gross Profit (Non-GAAP)** | **$14,305** | **$12,044** | Reconciliation to Adjusted EBITDA (in thousands) | Reconciliation to Adjusted EBITDA (in thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net loss (GAAP) | $(106,213) | $(218,914) | | Adjustments (Interest, Tax, D&A, etc.) | $7,478 | $66,945 | | **Adjusted EBITDA (Non-GAAP)** | **$(98,735)** | **$(151,969)** | [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section contains cautionary language regarding forward-looking statements, highlighting risks that actual results may differ materially from projections, particularly concerning clinical trial outcomes - The press release includes forward-looking statements concerning financial performance, clinical studies, and growth strategies, which are subject to risks and uncertainties[20](index=20&type=chunk) - A key risk highlighted is that final results from ongoing studies, such as the NHS-Galleri trial, may be inconsistent with interim results due to factors like the detection of prevalent late-stage cancers in the first screening round[21](index=21&type=chunk)

Core Insights - GRAIL, Inc. reported a total revenue of $31.8 million for Q1 2025, reflecting a 19% year-over-year growth, with U.S. Galleri revenue specifically at $28.7 million, marking a 22% increase [2][8] - The company achieved a net loss of $106.2 million for the quarter, which is an improvement of 51% compared to the previous year [2][8] - GRAIL's cash position stands at $677.9 million as of March 31, 2025, providing a financial runway into 2028 [3] Revenue and Financial Performance - Total revenue for the first quarter was $31.8 million, up from $26.7 million in the same period last year, indicating a growth of $5.1 million or 19% [2][8] - Galleri revenue reached $29.1 million, which is a 24% increase year-over-year [2] - Adjusted gross profit was reported at $14.3 million, an increase of 19% from the previous year [8] - Adjusted EBITDA for the quarter was $(98.7) million, showing an improvement of 35% compared to the prior year [8] Galleri Test and Clinical Trials - GRAIL completed a review of Galleri test performance in the NHS-Galleri trial, showing a higher positive predictive value (PPV) than previous studies [5][6] - The NHS-Galleri trial is the largest randomized controlled trial of any multi-cancer early detection (MCED) test, with final results expected in mid-2026 [7] - The trial aims to reduce late-stage cancer diagnoses through three consecutive years of screening [7] Business Developments and Partnerships - GRAIL has partnered with athenahealth to integrate Galleri test ordering into their electronic health record platform, enhancing test access for over 160,000 U.S. providers [14] - The company launched an educational initiative called Generation Possible, featuring actress Kate Walsh to raise awareness about MCED testing [14] Market Position and Future Outlook - GRAIL focuses on early cancer detection using next-generation sequencing and machine learning, aiming to alleviate the global burden of cancer [11] - The company plans to share registrational data from the PATHFINDER 2 study later this year, further advancing its market position in cancer detection [7]

Core Insights - GRAIL, Inc. has announced a partnership with athenahealth to integrate its Galleri multi-cancer early detection test into athenahealth's EHR solution, athenaOne, enhancing the ordering process for clinicians [1][2][3] Company Overview - GRAIL is focused on early cancer detection using advanced technologies such as next-generation sequencing and machine learning, aiming to alleviate the global burden of cancer [4] - The Galleri test identifies DNA shed by cancer cells through a simple blood draw, allowing for the detection of multiple deadly cancers before symptoms appear [6] Partnership Details - The integration with athenaCoordinator Core will enable over 160,000 U.S. clinicians to order the Galleri test directly within their EHR, streamlining the process and reducing administrative burdens [2][3] - The Galleri test results will be automatically available in the patient chart, further simplifying the workflow for healthcare providers [2] Test Specifications - The Galleri test is recommended for adults aged 50 or older with an elevated risk for cancer and should be used alongside standard cancer screenings [6][9] - The test can indicate the origin of cancer, providing healthcare providers with valuable information for further investigation [6] Sensitivity Data - The sensitivity of the Galleri test varies by cancer type, with pancreas cancer showing 83.7% sensitivity overall, and liver/bile duct cancer at 93.5% [8]

Core Insights - GRAIL, Inc. will release its financial results for the first quarter of 2025 on May 13, 2025, after market close [1] - A webcast and conference call will be held on the same day at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results and business progress [1] Company Overview - GRAIL is a healthcare company focused on early cancer detection, utilizing next-generation sequencing, clinical studies, and machine learning [4] - The company aims to alleviate the global burden of cancer by identifying multiple cancer types at earlier stages [4] - GRAIL's platform supports various aspects of cancer care, including 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]

Real-World Data in 100,000 Patients Further Support the Galleri® Test's Ability to Simultaneously Screen for Multiple Cancers, as Well as its Accuracy of Cancer Signal of Origin Prediction to Support More Efficient Diagnostic Evaluations Data From GRAIL's ctDNA-based Targeted Methylation Assay Highlight Potential to Identify Robust Signals of Promoter Methylation MENLO PARK, Calif., April 22, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when i ...

Group 1 - GRAIL, Inc. has made significant progress in establishing its Galleri test as a viable alternative for cancer screening since its spin-off from Illumina, Inc. in June 2024 [1] - The Galleri test is capable of screening for over 50 types of cancer, indicating its broad applicability in early detection [1]

Core Insights - GRAIL, Inc. is positioned to gain significantly if the proposed MCED (multi-cancer early detection) bill is enacted into law, highlighting the importance of this legislation for the company [1]. Company Overview - GRAIL, Inc. is recognized as a leader in the MCED testing market, indicating its strong position within the biopharma industry [1]. Industry Context - The introduction of the MCED bill is seen as a much-needed development, suggesting a growing recognition of the importance of early cancer detection technologies [1].

Financial Performance - The company incurred a net loss of $2.0 billion for fiscal year 2024, $1.5 billion for fiscal year 2023, and $5.4 billion for fiscal year 2022, with an accumulated deficit of $9.8 billion as of December 31, 2024[229]. - Future net losses will depend on the level of expenditures and the ability to generate additional revenue, with fluctuations expected from quarter to quarter[231]. - As of December 31, 2024, the company had $214.2 million in cash and cash equivalents and $549.2 million in short-term marketable securities, expected to fund operations for at least the next 12 months[277]. - The company may need to raise additional funds sooner than anticipated due to potential increases in spending and unforeseen circumstances[277]. - The ability to generate future revenue growth depends heavily on successful commercialization and market acceptance of products[267]. Research and Development - Significant investments have been made in research and development, particularly for the Galleri multi-cancer early detection test and precision oncology portfolio, with ongoing clinical studies to evaluate and improve these products[230]. - The company is continuing research and development of its proprietary methylation platform to develop enhanced versions of Galleri[273]. - The clinical study process is lengthy and expensive, with potential delays impacting the ability to launch products and seek regulatory approvals[239]. - The company faces potential delays in clinical studies due to various factors, including participant enrollment and regulatory approvals, which could increase costs and affect product development timelines[248]. - The company’s precision oncology offering relies heavily on collaborations with leading biopharmaceutical companies, and any delays or issues in these collaborations could impact the company's progress[246]. Regulatory Environment - The company plans to submit a premarket approval application (PMA) for an updated version of Galleri, which was launched in December 2024, and has received breakthrough device designation from the FDA[236]. - Regulatory requirements may necessitate additional clinical data, potentially delaying product approvals and impacting business operations[237]. - The FDA's new regulation on laboratory developed tests (LDTs) may impose significant obligations and costs, potentially harming the business if compliance is not achieved[350]. - The FDA finalized the LDT Final Rule on May 6, 2024, which phases out the enforcement discretion policy over four years, requiring LDTs to comply with standard medical device regulations[353]. - The company is subject to increased regulatory scrutiny, which may lead to higher costs and delays in product launches[368]. Market Adoption and Reimbursement - Galleri sales accounted for a substantial majority of the company's revenue since its launch in mid-2021, and this trend is expected to continue for the foreseeable future[249]. - The company is highly dependent on the adoption of Galleri as a widely used multi-cancer early detection (MCED) test, with growth strategy execution reliant on factors such as test order fulfillment and reimbursement coverage[249]. - The company has established private reimbursement for Galleri from several third-party payors in the U.S., but broader coverage from government healthcare programs like Medicare is still lacking[250]. - Medicare traditionally does not cover screening tests performed without signs or symptoms unless explicitly authorized, which poses a challenge for Galleri's reimbursement[252]. - The company is working with stakeholders to advance legislation for broader Medicare coverage of early cancer screening tests, but the process may take years and is subject to political dynamics[252]. Operational Risks - The company faces significant reputational and liability risks if its products result in patient harm or fail to perform as expected[282]. - The company is dependent on third parties for various operational services, and any disruption could adversely impact business operations[291]. - The company relies on Illumina as the sole supplier for next-generation sequencers and associated reagents, which poses risks if there are disruptions in supply[284]. - The company must ensure that third-party products used in its FDA submissions have the necessary clearances, which could delay product launches[287]. - The company’s laboratory in Durham, North Carolina, is critical for processing Galleri tests and any disruption could materially affect operations and revenue[289]. Human Resources - The company must attract and retain qualified personnel and maintain sales and marketing infrastructure to support product purchases and international expansion[233]. - As of December 31, 2024, the company had approximately 1,000 employees, following a reduction in headcount due to the Restructuring Plan[314]. - The company may face challenges in recruiting and retaining adequate sales and marketing personnel, which could inhibit product commercialization efforts[315]. - The company is highly dependent on key personnel, and the loss of any executive or key employee could delay product commercialization and harm business operations[321]. - The company faces intense competition for skilled personnel in its operational regions, which may limit its ability to hire and retain qualified employees[322]. Cybersecurity and Data Privacy - The company’s cybersecurity measures may be inadequate, exposing it to potential data breaches and regulatory liabilities[333]. - The company has made reductions in resources dedicated to information technology and cybersecurity, which may compromise the quality of its cybersecurity efforts[334]. - Cybersecurity incidents could lead to substantial liabilities, regulatory penalties, and reputational harm, impacting the company's financial condition and growth prospects[340]. - Compliance with evolving data privacy regulations, including HIPAA, is critical, as failure to comply could result in significant liability and reputational harm[380]. - The cost of compliance with data protection laws is expected to increase, potentially impacting the company's financial condition and operations[382]. Legal and Compliance Issues - The company is subject to ongoing litigation related to its acquisition by Illumina, which could adversely affect its financial condition and stock price[346]. - The FDA requires reporting of adverse medical events, and failure to comply could result in sanctions that harm the company's reputation and financial condition[415]. - The FDA and foreign regulatory bodies can mandate recalls of products due to material deficiencies, which could negatively affect sales and reputation[416]. - Companies must maintain records of recalls and corrections, and failure to do so could lead to enforcement actions by the FDA[418]. - Misuse or off-label use of products may result in product liability suits and regulatory investigations, impacting the company's reputation and financial health[422].

Core Insights - GRAIL, Inc. has launched an educational initiative called Generation Possible in partnership with actress Kate Walsh to promote awareness of multi-cancer early detection (MCED) testing, emphasizing the importance of early cancer detection for better treatment outcomes [1][2][3] Company Overview - GRAIL, Inc. is focused on early cancer detection using next-generation sequencing and advanced technologies to identify multiple cancer types at earlier stages, aiming to alleviate the global burden of cancer [4] Industry Context - Cancer remains a significant public health issue, with 46% of Americans aged 50-75 expressing concern about a cancer diagnosis. Despite the availability of recommended screenings for only five types of cancer, approximately 70% of cancer deaths are attributed to cancers without recommended screening tests [2][3] - Early diagnosis significantly improves survival rates, with a five-year survival rate being four times higher when cancer is detected early compared to late diagnosis [2][3] Initiative Details - Generation Possible aims to educate the public about the benefits of MCED testing, which is particularly relevant for individuals aged 50 and older who are at elevated risk for cancer. The initiative includes resources such as quizzes to assess the appropriateness of MCED testing and discussion guides for patients to communicate with their physicians [3][4]

Core Viewpoint - GRAIL, Inc. is focused on early cancer detection to improve treatment outcomes and will present at the TD Cowen 45th Annual Health Care Conference on March 4, 2025 [1] Company Overview - GRAIL is a healthcare company dedicated to detecting cancer early when it is more likely to be cured [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]