UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1525 O'Brien Drive x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXC ...

GRAIL (GRAL) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Good day, ladies and gentlemen, and welcome to the GRAIL First Quarter twenty twenty five Earnings Call. At this time, all participants are in 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. Speaker1 Thanks, operator, and thanks, everyone, for joining us today. On today's call are Bob Bergu ...

NEWS RELEASE Exhibit 99.1 GRAIL Reports First Quarter 2025 Financial Results Q1 U.S. Galleri Revenue Grew 22% Year-Over-Year to $28.7 Million GRAIL Announces Positive Top-Line Results From the Prevalent Screening Round of the NHS-Galleri Trial Cash Position of $677.9 Million Provides Runway Into 2028 MENLO PARK, Calif. — May 13, 2025 — 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 first qua ...

Q1 U.S. Galleri Revenue Grew 22% Year-Over-Year to $28.7 MillionGRAIL Announces Positive Top-Line Results From the Prevalent Screening Round of the NHS-Galleri TrialCash Position of $677.9 Million Provides Runway Into 2028MENLO PARK, Calif., May 13, 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 first quarter 2025.Total revenue in the first quarter was $31.8 million, rep ...

MENLO PARK, Calif., May 12, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced a new partnership with athenahealth, a leading provider of network-enabled software and services for healthcare practices and systems nationwide. This collaboration will integrate ordering of GRAIL's Galleri® multi-cancer early detection (MCED) test into athenaCoordinator Core, a service designed to help streamline laboratory order tr ...

MENLO PARK, Calif., April 29, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, announced today that it will issue financial results for the first quarter 2025 following the close of market on Tuesday, May 13, 2025. Following the release, company management will host a webcast and conference call at 1:30 p.m. PT / 4:30 p.m. ET to discuss results and business progress.First Quarter 2025 Webcast and Conference Call DetailsA link ...

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].