Price Target Changed • Aug 11
Price target increased by 9.7% to US$72.38 Up from US$66.00, the current price target is an average from 8 analysts. New target price is approximately in line with last closing price of US$75.48. Stock is up 125% over the past year. The company is forecast to post a net loss per share of US$10.03 next year compared to a net loss per share of US$11.11 last year. Aankondiging • Aug 09
GRAIL Announces FDA Advisory Committee Meeting To Review Premarket Approval Application For The Galleri Multi-Cancer Early Detection Test GRAIL announced that the U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on September 23, 2026 to review the Premarket Approval application for the Galleri multi-cancer early detection blood test. The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings. The Galleri technology is unique in how it is designed to examine the methylome using proprietary technology and artificial intelligence. Extensive data has been generated in multiple studies to evaluate the impact of adding Galleri to standard of care screening with positive results showing evidence of increases in screen detected cancers, a low false positive rate and high signal origin prediction accuracy. Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations. GRAIL submitted its PMA application for Galleri to the FDA on January 29, 2026. The FDA designated Galleri as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants with one year of follow up in the US-based PATHFINDER 2 study as well as data from over 70,000 participants from the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial, the largest and only randomized, controlled trial of an MCED test in an intended use population. The submission is also supported by an analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval. Live-nieuws • Aug 09
FDA Panel to Review GRAIL’s Galleri Multi-Cancer Test Application This September GRAIL said the FDA’s Molecular and Clinical Genetics Panel will meet on 23 September 2026 to review the Premarket Approval application for its Galleri multi-cancer early detection blood test, which has held Breakthrough Device designation since 2018.
The Galleri test is designed to identify cancer-specific methylation patterns before symptoms appear and indicate the likely tissue of origin to guide further diagnostic workups. This advisory committee review is a key regulatory step for one of GRAIL’s flagship products.
GRAIL’s stock recently traded at $69.48, with the share price down 21.8% year to date, putting extra focus on regulatory milestones such as the upcoming FDA panel meeting.
This FDA panel date provides a clear timeline for the next major regulatory risk event, since the committee’s discussion and voting outcomes often frame expectations for any subsequent FDA decision on a device like Galleri. Reported Earnings • Aug 06
Second quarter 2026 earnings: EPS and revenues exceed analyst expectations Second quarter 2026 results: US$2.56 loss per share (improved from US$3.19 loss in 2Q 2025). Revenue: US$44.7m (up 26% from 2Q 2025). Net loss: US$110.2m (loss narrowed 3.3% from 2Q 2025). Revenue exceeded analyst estimates by 5.4%. Earnings per share (EPS) also surpassed analyst estimates by 3.6%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. Aankondiging • Jul 30
GRAIL, Inc. to Report Q2, 2026 Results on Aug 05, 2026 GRAIL, Inc. announced that they will report Q2, 2026 results After-Market on Aug 05, 2026 Live-nieuws • Jul 17
GRAIL Expands Galleri Cancer Test Access With Priority Health Employer Coverage In Michigan GRAIL announced a collaboration with Priority Health to offer its Galleri multi-cancer early detection blood test to Priority Health’s self-insured employer groups, extending prior availability beyond Medicare Advantage plans and making Priority Health the first Michigan health plan to cover Galleri for employer groups.
The expansion into employer health plans widens potential access to Galleri, giving GRAIL another channel to reach commercially insured patients through workplace benefits rather than relying only on Medicare Advantage coverage.
GRAIL’s stock last traded at US$71.96, with the share price up 39.2% over the past 90 days, while the news reflects further commercial traction for its Galleri testing offering.
The key takeaway is that broader employer coverage could support wider use of GRAIL’s test, while also introducing execution risks related to employer uptake, clinical integration, and long-term reimbursement support. Live-nieuws • Jul 01
GRAIL Faces Securities Fraud Suit After Cancer Trial Disclosures Questioned GRAIL, Inc. and certain senior executives are facing a securities fraud class action in the U.S. District Court for the Northern District of California, alleging they misrepresented the design and results of the NHS-Galleri cancer detection trial and its failure to meet the primary endpoint of reducing late-stage cancers, following a stock price decline of more than 50%.
The complaint also claims GRAIL did not disclose concerns that the trial duration might be too short to show the intended endpoint, and investors who believe they were harmed have until August 4, 2026, to seek to join the lawsuit.
GRAIL’s stock last traded at US$68.27, with the share price down 23.2% year to date, which illustrates how legal and disclosure risks can feed directly into valuation pressure and raise the bar for investor confidence in clinical data. Aankondiging • Jun 26
GRAIL, Inc. announced that it has received $110.000075 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd., Samsung C&T Corporation On June 25, 2026, GRAIL, Inc. closed the transaction. Live-nieuws • Jun 22
Grail Faces Class Action Over NHS-Galleri Trial Disclosures and Data Concerns Multiple law firms have launched a securities class action against GRAIL, alleging the company made false and misleading statements about its NHS-Galleri cancer detection trial between May 13, 2025 and February 19, 2026, including claims it concealed adverse internal data and misrepresented the trial’s design and timeframe.
The lawsuit follows disclosures that the NHS-Galleri trial did not meet its primary endpoint of reducing late-stage (Stage III–IV) cancers, after which GRAIL’s stock reportedly fell about 50% in one session, creating substantial claimed losses for shareholders in the defined class period.
GRAIL shares most recently traded at $63.74, with the stock down 28.3% year to date, indicating a period of pressure as the company faces both clinical questions and securities litigation risk.
This type of suit can be lengthy and costly, and it adds an extra layer of uncertainty on top of trial outcomes that are central to GRAIL’s business model. Live-nieuws • Jun 10
Grail Faces Investor Lawsuits Over Alleged Misleading Cancer Trial Disclosures Multiple law firms have filed securities class action lawsuits against Grail, Inc. on behalf of investors who bought GRAL between May 13, 2025 and February 19, 2026.
The suits allege Grail made false and misleading statements about the effectiveness and primary endpoint results of its NHS-Galleri cancer screening trial.
Investors are being encouraged to seek compensation and to consider moving for lead plaintiff status, with an August 4, 2026 deadline to participate.
The key issue is whether Grail’s disclosures around the NHS-Galleri trial results were sufficiently accurate and complete, which now sits at the center of this litigation.
Investors considering GRAL or already holding it may want to track legal updates and company communications closely, since class action outcomes can affect legal costs, management focus and market perception. Reported Earnings • May 06
First quarter 2026 earnings: EPS and revenues exceed analyst expectations First quarter 2026 results: US$2.29 loss per share (improved from US$3.10 loss in 1Q 2025). Revenue: US$40.8m (up 28% from 1Q 2025). Net loss: US$93.2m (loss narrowed 12% from 1Q 2025). Revenue exceeded analyst estimates by 4.2%. Earnings per share (EPS) also surpassed analyst estimates by 17%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Aankondiging • Apr 30
GRAIL, Inc., Annual General Meeting, Jun 18, 2026 GRAIL, Inc., Annual General Meeting, Jun 18, 2026. Board Change • Apr 29
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. Independent Director Bill Chase is the most experienced director on the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Apr 23
GRAIL, Inc. to Report Q1, 2026 Results on May 05, 2026 GRAIL, Inc. announced that they will report Q1, 2026 results After-Market on May 05, 2026 Recent Insider Transactions • Apr 17
CEO & Director recently sold US$6.2m worth of stock On the 8th of April, Robert Ragusa sold around 124k shares on-market at roughly US$49.92 per share. This transaction amounted to 29% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$15m. Recent Insider Transactions Derivative • Apr 08
CEO & Director notifies of intention to sell stock Robert Ragusa intends to sell 133k shares in the next 90 days after lodging an Intent To Sell Form on the 6th of April. If the sale is conducted around the recent share price of US$51.74, it would amount to US$6.9m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2025, Robert's direct individual holding has increased from 205.85k shares to 218.25k. Company insiders have collectively sold US$23m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Apr 08
GRAIL, Inc. Announces Integration of Galleri Test into Epic Electronic Health Record Platform GRAIL, Inc. announced a collaboration with Epic to bring the Galleri multi-cancer early detection test into one of the nation's most widely used electronic health record platforms, supporting broader adoption across health systems in the United States. Epic is a leading EHR platform used by many of the largest and most advanced health systems. Integration through Epic Aura will allow interested health systems and their healthcare providers to order the Galleri test directly at the point of care, receive results, and manage patient follow-up seamlessly within their existing native EHR and within their existing clinical workflows. Through this integration, clinicians using Epic can access the Galleri test within their native EHR environment, helping to eliminate administrative burden, reduce manual processes, and improve the overall provider and patient experience. Implementation planning began in the first quarter of 2026, including initial integrations and early adopter programs. GRAIL will work closely with Epic and AWS, the preferred cloud provider for GRAIL, along with any interested health systems, community healthcare providers, and retail health clinics to support workflow alignment, training and deployment success. Broad availability is expected by the end of 2026. The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer. The Galleri test increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and lung cancers, and has the lowest false positive rate of any MCED test on the market. The Galleri test doubles the number of cancers detected when added to standard of care cancer screening, and has the lowest false positive rate of any MCED test. When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older. Price Target Changed • Mar 29
Price target decreased by 18% to US$72.40 Down from US$88.00, the current price target is an average from 5 analysts. New target price is 49% above last closing price of US$48.49. Stock is up 80% over the past year. The company is forecast to post a net loss per share of US$11.02 next year compared to a net loss per share of US$11.11 last year. Recent Insider Transactions • Mar 11
CEO & Director recently sold US$409k worth of stock On the 9th of March, Robert Ragusa sold around 8k shares on-market at roughly US$48.48 per share. This transaction amounted to 1.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$7.4m. Recent Insider Transactions Derivative • Mar 03
CEO & Director notifies of intention to sell stock Robert Ragusa intends to sell 41k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of March. If the sale is conducted around the recent share price of US$53.23, it would amount to US$2.2m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since March 2025, Robert's direct individual holding has increased from 127.65k shares to 173.43k. Company insiders have collectively sold US$20m more than they bought, via options and on-market transactions in the last 12 months. Price Target Changed • Feb 22
Price target decreased by 13% to US$101 Down from US$115, the current price target is an average from 4 analysts. New target price is 100% above last closing price of US$50.21. Stock is up 23% over the past year. The company is forecast to post a net loss per share of US$10.95 next year compared to a net loss per share of US$11.11 last year. New Risk • Feb 21
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings are forecast to decline by an average of 3.7% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$539m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Significant insider selling over the past 3 months (US$7.6m sold). Reported Earnings • Feb 20
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: US$11.11 loss per share (improved from US$63.54 loss in FY 2024). Revenue: US$147.2m (up 17% from FY 2024). Net loss: US$408.4m (loss narrowed 80% from FY 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 2.6%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Aankondiging • Feb 20
GRAIL, Inc. Announces NHS Galleri Trial Demonstrates A Substantial Reduction in Stage IV Cancer Diagnoses, Increased Stage I and II Detection of Deadly Cancers, and Four-Fold Higher Cancer Detection Rate GRAIL, Inc. announced topline results from the landmark, randomized, controlled NHS-Galleri trial, which evaluated annual multi-cancer screening with the Galleri test in England's National Health Service (NHS) over three years in 142,000 demographically representative participants aged 50 to 77. The clinical performance of Galleri has been rigorously established in several studies, and the NHS-Galleri trial was designed to demonstrate population-level impact through the reduction of late stage cancer diagnoses and increased cancer detection rate within the NHS to inform a decision about a national screening program in England. For the US market, the Galleri premarket approval application pending review by the FDA also includes metrics from the NHS-Galleri trial that are focused on test performance, clinical validation, and the clinical benefit of detection at Stages I through III, including reduction in Stage IV cancer diagnoses. Key trial results include: The primary endpoint of statistically significant Stage III-IV reduction was not observed. However, there was a favorable trend toward fewer Stage III-IV cancers in a pre-specified group of 12 deadly cancers in the intervention arm after the prevalent screening round. Adding Galleri to standard of care screening resulted in a substantial and clinically meaningful reduction in Stage IV diagnoses compared with standard of care alone across the pre-specified group of 12 deadly cancers. Stage IV diagnoses in these cancers decreased with each year of sequential screening, with a greater than 20% reduction in the second and third rounds. Similar reductions were observed across all cancers. Annual screening with the Galleri test plus standard of care screening resulted in a four-fold improvement in the overall cancer detection rate compared to standard of care screening alone in England for breast, colorectal, cervical and high risk lung cancer. Substantial increase in the absolute number of Stage I-II cancers in the 12 pre-specified deadly cancer types that are typically found in late stages were observed in the intervention arm. Screening with the Galleri test resulted in a substantial reduction in the number of cancers detected clinically through emergency presentation, which are associated with significantly higher mortality and healthcare costs. The Galleri test's performance – positive predictive value (PPV), specificity and Cancer Signal of Origin (CSO) accuracy – was consistent with the range previously reported from GRAIL's North American studies. Importantly, no serious safety concerns were reported in participants who received the Galleri test in the NHS-Galleri trial. Additional analyses are underway to better understand these rich data, and detailed results will be submitted for presentation at the ASCO 2026 Annual Meeting. Of note, there was a higher than anticipated incidence of Stage III cancers in the NHS-Galleri trial. In both the US and the NHS data, the time to diagnostic resolution appears to improve over time as physicians gain experience with the Galleri test and diagnostic workup. The number and distribution of cancer stages across screening rounds suggests the potential for a stronger effect with longer follow up as data matures, and GRAIL plans to extend the trial's follow up period by 6-12 months. Aankondiging • Feb 16
GRAIL, Inc. to Report Q4, 2025 Results on Feb 19, 2026 GRAIL, Inc. announced that they will report Q4, 2025 results After-Market on Feb 19, 2026 Aankondiging • Jan 30
GRAIL, Inc. Submits FDA Premarket Approval Application for the Galleri®? Multi-Cancer Early Detection Test GRAIL, Inc. announced the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri®? multi-cancer early detection (MCED) test. The FDA designated the test as a Breakthrough Device in 2018. The PMA submission is focused on the test performance and safety results from 25,490 consented participants in the US-based PATHFINDER 2 study with one year of follow up and from the prevalent screening round (first year) of the NHS-Galleri trial, the largest, and only, randomized, controlled trial of any MCED test in an intended use population. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated PMA version that has been submitted to the FDA for premarket approval. About the NHS-Galleri trial (NCT05611632) The NHS-Galleri trial is the first and only prospective, randomized, controlled trial to assess the clinical utility and performance of a multi-cancer early detection test for population screening when added to standard care. PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of the Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and performance of theGalleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Aankondiging • Jan 15
GRAIL, Inc. Provides Earnings Guidance for the Full Year 2025 GRAIL, Inc. provided earnings guidance for the full year 2025. Revenue is expected to be between $147 million and $148 million, approximately 17% to 18% growth over 2024. Recent Insider Transactions • Dec 07
CEO & Director recently sold US$3.8m worth of stock On the 3rd of December, Robert Ragusa sold around 40k shares on-market at roughly US$95.24 per share. This transaction amounted to 19% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$5.1m. Robert has been a net seller over the last 12 months, reducing personal holdings by US$7.8m. Recent Insider Transactions Derivative • Dec 04
Chief Financial Officer notifies of intention to sell stock Aaron Freidin intends to sell 25k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of December. If the sale is conducted around the recent share price of US$99.15, it would amount to US$2.5m. Since March 2025, Aaron's direct individual holding has increased from 45.05k shares to 78.95k. Company insiders have collectively sold US$13m more than they bought, via options and on-market transactions in the last 12 months. New Risk • Nov 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 3.8% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$538m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Significant insider selling over the past 3 months (US$5.7m sold). Aankondiging • Nov 14
GRAIL, Inc. has filed a Follow-on Equity Offering in the amount of $300 million. GRAIL, Inc. has filed a Follow-on Equity Offering in the amount of $300 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Reported Earnings • Nov 14
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third quarter 2025 results: US$2.46 loss per share (improved from US$3.94 loss in 3Q 2024). Revenue: US$36.2m (up 26% from 3Q 2024). Net loss: US$89.0m (loss narrowed 29% from 3Q 2024). Revenue exceeded analyst estimates by 2.2%. Earnings per share (EPS) also surpassed analyst estimates by 29%. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Aankondiging • Nov 08
GRAIL, Inc. announced that it has received $324.999987 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd., Samsung C&T Corporation On November 7, 2025, GRAIL, Inc closed the transaction. The transaction included participation from 17 investors. Aankondiging • Oct 30
GRAIL, Inc. to Report Q3, 2025 Results on Nov 12, 2025 GRAIL, Inc. announced that they will report Q3, 2025 results After-Market on Nov 12, 2025 Aankondiging • Oct 21
Grail, Inc. and University of Oxford to Present Long-Term Data from the Symplify Study Evaluating the Galleri®? Multi-Cancer Early Detection Test in Symptomatic Individuals At the Early Detection of Cancer Conference GRAIL, Inc. and the University of Oxford announced that positive long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon. SYMPLIFY, a prospective observational study, is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented with symptoms to primary care and were referred for diagnostic follow-up for suspicion of cancer. In SYMPLIFY, the Galleri®? test was used to assess blood samples from more than 6,000 participants with symptoms of cancer who followed standard diagnostic pathways. However, as a non-interventional study, the results of the tests were unknown to physicians and did not inform the approach to diagnosis. No MCED results were returned to participants or their clinicians during the study. Previous SYMPLIFY results showed potential of MCED testing in people with symptoms suggestive of cancer Most people diagnosed with cancer visit primary care with symptoms before diagnosis1. The fact that, in all but one of the additional patients diagnosed with cancer, a Galleri CSO prediction correctly identified the cancer type, including in many cases where the symptoms were non-specific, further reinforces the value of the Galleri test's CSO capability. Recent Insider Transactions • Oct 18
CEO & Director recently sold US$499k worth of stock On the 15th of October, Robert Ragusa sold around 7k shares on-market at roughly US$68.88 per share. This transaction amounted to 3.3% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$5.1m. Robert has been a net seller over the last 12 months, reducing personal holdings by US$4.0m. Aankondiging • Oct 18
GRAIL, Inc. Announces Positive Performance and Safety Results from its Registrational Pathfind 2 Study GRAIL, Inc. announced that positive performance and safety results from its registrational PATHFINDER 2 study are being presented at the European Society for Medical Oncology (ESMO) Congress 20251. The largest interventional study of an MCED test in the United States to date, the prospective PATHFINDER 2 study includes 35,878 enrolled participants across the United States and Canada in a broad, intended-use population of adults aged 50 and older with no clinical pinpoint of cancer. Results were presented from a pre-specified analysis of the first 25,578 participants with at least 12 months of follow-up as of Dec. 31, 2024. The likelihood of receiving a cancer diagnosis following a positive test result (positive predictive value) was 61.6%, substantially higher than in the previous PATHFINDER study of Galleri. Since PATHFINDER 2 is a prospective clinical trial where the cancer status of participants is unknown at the outset, episode sensitivity - the ability to detect cancer that could be confirmed within 12 months after the blood draw - is a performance measure of the study. Data from this study will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premium approval (PMA) application, along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA a bridging analysis to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The primary objectives of the study are 1) to evaluate the safety and performance of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the GalleriMCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal detected does not rule out cancer. A test result of Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirmatory diagnostic evaluation by medically establish procedures (e.g., Imaging) to confirm cancer. The Galleri test was developed -- and its performance characteristics were determined -- by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about GRAIL, Inc. (the "Company"), include the benefits and use of the Galleri test, the potential of the Galleri MCED tests, expectations regarding the final results of the PATHFINDER 2 Study, upcoming events and presentations, the timeline and results of a bridging analysis to the FDA, the applicability of the Galleri test, and the applicability of the Galler test, and the timeline for completion of the PMO and the timeline for completion of The PMO and the first phase of the study. Aankondiging • Oct 17
GRAIL, Inc. announced that it expects to receive $110.000075 million in funding from Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd and Samsung C&T Corporation GRAIL, Inc. entered into a stock purchase agreement for issuance of 1,570,308 common shares at a price of $70.05 per share for gross proceeds of $110,000,075.4 on October 16, 2025. The transaction included participation from new investors Samsung Electronics Co., Ltd., Samsung Electronics Singapore Pte. Ltd. and Samsung C&T Corporation. The Private Placement is exempt from the registration requirements of the Securities Act, pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) and/or Rule 506 of Regulation D under the Securities Act and in reliance on similar exemptions under applicable state laws. The transaction closing is subject to regulatory approvals. Recent Insider Transactions Derivative • Oct 16
President notifies of intention to sell stock Joshua Ofman intends to sell 15k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of October. If the sale is conducted around the recent share price of US$69.29, it would amount to US$1.0m. Since March 2025, Joshua's direct individual holding has increased from 76.44k shares to 166.72k. Company insiders have collectively sold US$12m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Oct 10
President recently sold US$5.1m worth of stock On the 6th of October, Joshua Ofman sold around 81k shares on-market at roughly US$62.50 per share. This transaction amounted to 33% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Joshua has been a net seller over the last 12 months, reducing personal holdings by US$6.9m. Recent Insider Transactions Derivative • Oct 03
President notifies of intention to sell stock Joshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 2nd of October. If the sale is conducted around the recent share price of US$62.06, it would amount to US$601k. Since December 2024, Joshua's direct individual holding has increased from 72.25k shares to 104.99k. Company insiders have collectively sold US$9.0m more than they bought, via options and on-market transactions in the last 12 months. New Risk • Sep 29
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$501m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (16% increase in shares outstanding). Reported Earnings • Aug 13
Second quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2025 results: US$3.19 loss per share (improved from US$51.06 loss in 2Q 2024). Revenue: US$35.5m (up 11% from 2Q 2024). Net loss: US$114.0m (loss narrowed 93% from 2Q 2024). Revenue missed analyst estimates by 3.7%. Earnings per share (EPS) exceeded analyst estimates by 13%. Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Aankondiging • Aug 13
GRAIL, Inc. Reports Impairment Charges for the Second Quarter Ended June 30, 2025 GRAIL, Inc. reported impairment charges for the second quarter ended June 30, 2025. For the quarter, the company reported goodwill and intangible impairment of $28,000,000 against $1,420,936,000 a year ago. Aankondiging • Jul 30
GRAIL, Inc. to Report Q2, 2025 Results on Aug 12, 2025 GRAIL, Inc. announced that they will report Q2, 2025 results After-Market on Aug 12, 2025 Recent Insider Transactions Derivative • Jul 16
Chief Financial Officer notifies of intention to sell stock Aaron Freidin intends to sell 8k shares in the next 90 days after lodging an Intent To Sell Form on the 15th of July. If the sale is conducted around the recent share price of US$40.18, it would amount to US$321k. Since September 2024, Aaron's direct individual holding has increased from 15.01k shares to 83.87k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Jul 01
President notifies of intention to sell stock Joshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 30th of June. If the sale is conducted around the recent share price of US$48.39, it would amount to US$469k. Since September 2024, Joshua's direct individual holding has increased from 72.25k shares to 110.81k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Jun 18
GRAIL, Inc. Announces Positive Top-Line Results from The Galleri PATHFINDER 2 Registrational Study GRAIL, Inc. 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 performance of the Galleri®? multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer. PATHFINDER 2 study results will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA), along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026. Detailed results from the PATHFINDER 2 Study (NCT05155605). PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and effectiveness of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED tests across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Use of the test is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs, and symptoms. A test result of No Cancer Signal detected does not rule out cancer. A test result of Cancer Signal detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirmatory diagnostic evaluation by medically establish procedures (e.g., Imaging) to confirmatory diagnostic evaluation of cancer, including due to the cancer being located in a different part of the body. false negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed -- and its performance characteristics were determined -- by GRAIL. The Galleri test has not been cleared or approved by the Food and Drug Administration. The Galleri test was regulated under CLIA to perform high-complexity testing. Recent Insider Transactions Derivative • Jun 13
President notifies of intention to sell stock Joshua Ofman intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 12th of June. If the sale is conducted around the recent share price of US$43.87, it would amount to US$425k. Since June 2024, Joshua's direct individual holding has increased from 7.93k shares to 120.50k. Company insiders have collectively sold US$10m more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • May 14
First quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2025 results: US$3.10 loss per share. Revenue: US$31.8m (up 19% from 1Q 2024). Net loss: US$106.2m (loss narrowed 52% from 1Q 2024). Revenue missed analyst estimates by 9.6%. Earnings per share (EPS) exceeded analyst estimates by 22%. Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Recent Insider Transactions • May 08
CEO & Director recently sold US$3.2m worth of stock On the 2nd of May, Robert Ragusa sold around 94k shares on-market at roughly US$33.93 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$5.2m. Recent Insider Transactions Derivative • May 01
CEO & Director notifies of intention to sell stock Robert Ragusa intends to sell 96k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of May. If the sale is conducted around the recent share price of US$36.81, it would amount to US$3.5m. For the year to December 2022, Robert's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2024, Robert's direct individual holding has increased from 857.00 shares to 127.65k. Company insiders have collectively sold US$4.1m more than they bought, via options and on-market transactions in the last 12 months. Aankondiging • Apr 30
GRAIL, Inc. to Report Q1, 2025 Results on May 13, 2025 GRAIL, Inc. announced that they will report Q1, 2025 results After-Market on May 13, 2025 Aankondiging • Apr 17
GRAIL, Inc., Annual General Meeting, May 29, 2025 GRAIL, Inc., Annual General Meeting, May 29, 2025. Recent Insider Transactions • Mar 16
CEO & Director recently sold US$238k worth of stock On the 7th of March, Robert Ragusa sold around 8k shares on-market at roughly US$31.21 per share. This transaction amounted to 6.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Robert has been a net seller over the last 12 months, reducing personal holdings by US$2.0m. Reported Earnings • Feb 21
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: US$63.54 loss per share. Revenue: US$125.6m (up 35% from FY 2023). Net loss: US$2.03b (loss widened 38% from FY 2023). Revenue exceeded analyst estimates by 2.7%. Earnings per share (EPS) also surpassed analyst estimates by 4.7%. Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. New Risk • Feb 13
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (19% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$608m net loss in 3 years). Significant insider selling over the past 3 months (US$427k sold). Aankondiging • Feb 13
GRAIL, Inc. to Report Q4, 2024 Results on Feb 20, 2025 GRAIL, Inc. announced that they will report Q4, 2024 results After-Market on Feb 20, 2025 Aankondiging • Jan 14
GRAIL, Inc. Announces Patient-Based Outcomes (PRO) Assessing Patient Prospective from the Pathfinder Study GRAIL, Inc. announced that patient-reported outcomes (PRO) assessing patient perspectives from the PATHFINDER study were published in Lancet Oncology. The PATHFINDER study included secondary and exploratory outcomes with the objective of assessing PRO and perceptions of multi-cancer early detection (MCED) testing. PRO assessment was conducted for eligible PATHFINDER study participants with either a cancer signal detected (CSD) or no cancer signal detected (NCSD) over a 12-month follow-up period. In the PATHFINDER study, general anxiety, distress and uncertainty after results disclosure, health-related quality of life, satisfaction with the Galleri® test, and intent towards guideline-recommended screening and repeat MCED testing were assessed. Three instruments used to assess PRO included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty and positive experience at MCED test result disclosure, PRO Measurement Information System (PROMIS) Anxiety short-form for anxiety symptoms, the Short Form 12-Item Health Survey (SF-12v2) for health-related quality of Life, and a satisfaction questionnaire. Overall the study demonstrated minimal patient distress associated with MCED testing. Most participants with a NCSD result responded that they were "relieved about my test result." The negative patient-reported impacts associated with a CSD test result were small and returned to baseline within 12 months. High overall satisfaction with the MCED test was reported across participant groups regardless of signal detection status and eventual diagnosis. Most participants reported they were " likely"/"very likely" to adhere to future guideline recommended screening tests as recommended by their healthcare provider. New Risk • Dec 18
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$572m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Significant insider selling over the past 3 months (US$2.2m sold). 
