GRAIL to Announce Fourth Quarter and Full Year 2025 Financial Results [Accessibility Statement] Skip NavigationMENLO PARK, Calif., Feb. 16, 2026 /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 fourth quarter and full year 2025 following the close of market on Thursday, Feb. 19, 2026. Following the release, company management will host a webcast and conference call at 2: ...

Core Viewpoint - The Super Bowl advertisement by Hims & Hers has raised concerns regarding the reliability and ethical implications of its newly launched cancer-detection test, which aims to detect over 50 types of cancer before symptoms appear [1][2]. Product Overview - The cancer-detection test, developed by Grail Inc., is designed to identify hard-to-detect cancers such as pancreatic and ovarian, which currently lack routine screening options [2]. - The advertisement suggests that the test democratizes access to healthcare, providing the same opportunities for cancer detection to all individuals, regardless of their socioeconomic status [2]. Reliability Concerns - Critics have questioned the test's reliability, noting that Grail Inc. recommends follow-up medical testing to confirm any cancer diagnosis [3]. - Interim results indicate that the test detects approximately 40% of cancers, meaning it misses more than half of cases even when cancer is present [3]. Expert Opinions - Eric Topol from Scripps Research acknowledged that the test could be beneficial for individuals at high risk of cancer but cautioned that widespread use might lead to financial waste and misleading results [4]. Pricing and Accessibility - Hims & Hers plans to offer the test to subscribers of its $350 lab service at a price of $700, which is about a 25% discount from the manufacturer's list price [4]. Regulatory Status - Grail has sought approval from the FDA under the most stringent regulatory pathway for medical devices and diagnostics [5]. Financial Performance - Hims & Hers reported disappointing Q3 earnings, with an EPS of 6 cents, missing estimates, while revenue reached $598.97 million, exceeding expectations [6]. - The company has guided fourth-quarter revenue below consensus and adjusted its 2025 revenue outlook to align with analyst forecasts [6]. Market Performance - Hims & Hers is ranked in the 87th percentile for growth and the 7th percentile for value, indicating mixed performance [7]. - Over the past year, the stock has declined by 48.58%, closing at $23.02 after a 1.96% drop on the last trading day [7].

Core Insights - GRAIL, Inc. has submitted the final module of its premarket approval application to the FDA for the Galleri multi-cancer early detection test, which has received Breakthrough Device designation since 2018, indicating its potential to enhance early cancer detection [2][5] - The PMA submission is based on data from the PATHFINDER 2 study and the NHS-Galleri trial, which collectively involved over 25,000 participants, aiming to improve cancer detection rates, especially for high-mortality cancers that lack routine screening options [3][7][11] Company Developments - The Galleri test is positioned to significantly impact public health by improving early cancer detection rates, particularly for cancers diagnosed at advanced stages [3][5] - GRAIL's stock has seen a substantial increase of 195.1% over the past six months, outperforming the industry and S&P 500 [4] - The company currently has a market capitalization of $3.94 billion [6] Clinical Studies and Data - The NHS-Galleri trial enrolled over 140,000 asymptomatic individuals aged 50-77, focusing on reducing stage III-IV cancer diagnoses and assessing the test's performance across multiple cancer types [8] - The PATHFINDER 2 study aims to evaluate the safety and performance of the Galleri test in 35,000 participants, with primary endpoints related to diagnostic procedures following a cancer signal detected result [9][10] Market Prospects - The cancer diagnostics market is projected to grow from $170 billion in 2025 at a CAGR of 8.6% through 2034, driven by increasing cancer patient numbers and the benefits of early diagnosis [12][14] - GRAIL's collaboration with Samsung to commercialize the Galleri test in Asian markets, supported by a $110 million equity investment, enhances its international expansion strategy [17]

Core Insights - GRAIL, Inc. has submitted the final module of the Premarket Approval (PMA) application for its Galleri multi-cancer early detection (MCED) test to the FDA, marking a significant milestone in early cancer detection [1][2] - The Galleri test has been designated as a Breakthrough Device by the FDA since 2018, highlighting its potential to improve cancer screening outcomes [1][2] Company Overview - GRAIL is focused on early cancer detection using next-generation sequencing and advanced machine learning technologies, aiming to alleviate the global burden of cancer [5] - The company is headquartered in Menlo Park, California, with additional locations in Washington, D.C., North Carolina, and the United Kingdom [5] Clinical Studies - The PMA submission is based on data from the PATHFINDER 2 study, which involved 25,490 participants, and the NHS-Galleri trial, the largest randomized controlled trial of any MCED test [2][3] - The NHS-Galleri trial recruited over 140,000 asymptomatic participants aged 50 to 77, aiming to demonstrate a reduction in late-stage cancers among those who received the Galleri test [3] - The PATHFINDER 2 study evaluates the safety and performance of the Galleri test in approximately 35,000 individuals eligible for cancer screening, focusing on diagnostic evaluations and performance metrics [4] Test Performance and Objectives - The primary objective of the NHS-Galleri trial is to show a reduction in late-stage (III-IV) cancers, particularly in a pre-specified group of 12 cancer types that account for about two-thirds of cancer deaths in England and the U.S. [3] - Secondary objectives include assessing the performance of the Galleri test in terms of positive predictive value, false positive rate, cancer detection rate, and healthcare resource utilization [3][4]

Core Insights - Grail's stock has seen a significant increase of over 13% due to growing optimism about its future prospects, particularly for 2026, following a positive presentation at the JPMorgan Healthcare Conference [1] Financial Performance - Grail's Galleri MCED test has been commercially available for four years, generating sales with projected total revenue for 2025 estimated between $147 million and $148 million, primarily driven by Galleri, which is expected to contribute $136 million to $137 million [2] - For 2026, management anticipates Galleri revenue growth of 22% to 32%, while cash burn is expected to decrease to $274 million in 2025 from $579 million in 2024, supported by a cash position of $904 million [3] Regulatory Developments - A key driver of excitement for Grail is its planned premarket approval (PMA) submission to the FDA in the first quarter of 2026, which could enhance medical and insurance coverage for the Galleri test, as well as improve marketing and physician adoption [4] - The PMA submission will be supported by data from the Pathfinder 2 trial in the U.S. and a large-scale trial in the U.K. involving 140,000 participants, which may facilitate U.K. adoption of the test [5]

Core Insights - The article emphasizes the importance of understanding market dynamics and the potential impact of macroeconomic factors on investment strategies [2] Group 1: Market Analysis - The current market environment is characterized by volatility, influenced by geopolitical tensions and economic indicators [2] - Analysts suggest that investors should remain cautious and consider diversifying their portfolios to mitigate risks associated with market fluctuations [2] Group 2: Company Performance - Recent earnings reports indicate a mixed performance across various sectors, with some companies exceeding expectations while others fall short [2] - Specific companies have shown resilience in adapting to changing market conditions, highlighting the importance of strategic management [2]

Company Overview - GRAIL has made significant progress since launching Galleri in 2021, which allows individuals and their physicians to detect cancers before symptoms appear, often at earlier stages [3] - Galleri is recognized as the first multi-cancer early detection test, establishing a new paradigm in cancer screening [3] Product Performance - The performance of Galleri has been validated through various studies, including a recent analysis involving the first 25,000 participants [3]

Summary of GRAIL's Conference Call Company Overview - **Company**: GRAIL - **Product**: Galleri, a multi-cancer early detection test launched in 2021 - **Industry**: Cancer screening and diagnostics Key Points and Arguments Business Progress and Financials - GRAIL has completed over 800,000 Galleri tests and sold more than 185,000 tests in 2025, indicating strong commercial momentum [4][7] - Revenue for 2025 is projected to be between $147 million and $148 million, representing a growth of approximately 17%-18% over 2024 [9] - The company ended 2025 with $904 million in cash, providing a strong capital position for future growth [5] - Cash burn for 2025 was approximately $274 million, significantly reduced from $579 million in 2024 due to organizational restructuring [10] Market Expansion and Partnerships - GRAIL plans to expand Galleri in the U.S. and international markets, with partnerships established in Israel, Canada, and South Korea [9][24] - The prescriber base grew by approximately 30% in 2025, reaching over 17,000 prescribers, indicating increased adoption among healthcare providers [7] - The company is working with operational partners like Quest and Athena to streamline test ordering and execution [8] Clinical Validation and Performance - Galleri is the only multi-cancer early detection test with published validation data in the intended use population, demonstrating a positive predictive value of 62% and a false positive rate of 0.4% [14][20] - The PATHFINDER 2 study showed a seven-fold increase in cancer detection rates when Galleri was added to standard screenings, with over half of detected cancers found at early stages [19][20] - The test is designed to detect over 100 types of cancer, significantly more than the 14% detection rate of current single cancer screenings [12][15] Future Outlook and Regulatory Plans - GRAIL expects to file for PMA (Pre-Market Approval) in Q1 2026 and present full data sets from major studies in mid-2026 [6][21] - The company anticipates total Galleri revenue growth of 22%-32% in 2026, with cash burn expected to be less than $300 million [10] Strategic Vision - GRAIL aims to transform cancer screening by moving away from individual cancer tests to a comprehensive approach that detects multiple cancers simultaneously [12][13] - The company emphasizes the importance of clinical utility and aims to demonstrate the reduction of late-stage cancer incidence through its testing [22][24] Additional Important Insights - GRAIL's automated lab infrastructure allows for a testing capacity of one million samples per year, with plans for further expansion [18] - The company is focused on achieving FDA approval, which is expected to enhance market adoption and reimbursement opportunities [24] - GRAIL's strategy includes leveraging consumer empowerment trends in healthcare, which may increase self-pay market growth for preventive services like Galleri [24] This summary encapsulates the key points discussed during the conference call, highlighting GRAIL's business progress, market strategies, clinical validation, and future outlook in the cancer screening industry.

Corporate Update - GRAIL, Inc. plans to present a corporate update and preliminary financial information for the quarter and year ended December 31, 2025 at the 2026 J.P. Morgan Healthcare Conference[4] - The presentation will include results of operations and financial condition, which are expected to be detailed in Exhibit 99.1[6] Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[3]

44th Annual J.P. Morgan Healthcare Conference January 12, 2026 Bob Ragusa, Chief Executive Officer Josh Ofman, President 1 This presentation contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking stat ...