Cancer Detection and Positive Predictive Value Substantially Higher Than the Previously Published PATHFINDER StudyMENLO PARK, Calif., June 18, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL's registrational PATHFINDER 2 study. PATHFINDER 2 was initiated in 2021 to evaluate the safety and ...

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]

MENLO PARK, Calif., May 21, 2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that company management will present at the Jefferies Global Healthcare Conference 2025 in New York on Tuesday, June 4 at 11:40 a.m. ET. Live and replay webcasts may be accessed in the investor relations section of GRAIL's website at investors.grail.com. The webcast will be archived and available for reply for at least 30 days after t ...

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 Company Participants None - ExecutiveBob Ragusa - CEO & Board MemberHarpal Kumar - President Biopharma Business & EuropeJoshua Ofman - PresidentAaron Freidin - Chief Financial OfficerSubbu Nambi - Managing DirectorDoug Schenkel - Managing Director Conference Call Participants Tejas Savant - Executive Director & Senior Healthcare Equity AnalystKyle Mikson - Managing Director & Senior Research Analyst Operator Good day, ladies and gentlemen, and welc ...

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 ...