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. Reported Earnings • Aug 07
Second quarter 2026 earnings released: US$2.56 loss per share (vs US$3.19 loss in 2Q 2025) 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 is forecast to grow 25% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. 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 Board Change • Jun 26
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 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 • 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. Board Change • May 28
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. Board Change • May 11
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 30
GRAIL, Inc., Annual General Meeting, Jun 18, 2026 GRAIL, Inc., Annual General Meeting, Jun 18, 2026. 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 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. Recent Insider Transactions • Mar 12
CEO & Director recently sold €353k worth of stock On the 9th of March, Robert Ragusa sold around 8k shares on-market at roughly €41.82 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 €6.4m. Reported Earnings • Feb 20
Full year 2025 earnings released: US$11.11 loss per share (vs US$63.54 loss in FY 2024) 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 is forecast to grow 24% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. 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 €3.3m worth of stock On the 3rd of December, Robert Ragusa sold around 40k shares on-market at roughly €81.65 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 €4.3m. Robert has been a net seller over the last 12 months, reducing personal holdings by €6.8m. 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 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 20
CEO & Director recently sold €429k worth of stock On the 15th of October, Robert Ragusa sold around 7k shares on-market at roughly €59.21 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 €4.3m. Robert has been a net seller over the last 12 months, reducing personal holdings by €3.5m. 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 • Oct 10
President recently sold €4.3m worth of stock On the 6th of October, Joshua Ofman sold around 81k shares on-market at roughly €53.37 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 €6.0m. 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 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. Reported Earnings • May 15
First quarter 2025 earnings released 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 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 Europe. 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. Board Change • Mar 31
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 1 independent director. 6 non-independent directors. Independent Director Sarah Krevans was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Reported Earnings • Feb 21
Full year 2024 earnings released 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 is forecast to grow 14% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in Europe. 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. Aankondiging • Nov 19
GRAIL Announces First Patient Tested With Blood-Based Assay in Global Phase 3 Adjuvant Lung Cancer Study GRAIL, Inc. announced that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC. The study is sponsored by AstraZeneca in collaboration with Daiichi Sankyo. The study, which is being conducted under an FDA-approved Investigational Device Exemption application, held by GRAIL, leverages GRAIL's targeted methylation platform to detect ctDNA. With GRAIL's blood-only approach, tissue analysis and bespoke panel development are not required, enabling simple integration into pharmaceutical clinical trial workflows. In TROPION-Lung12, patients will be screened with the GRAIL assay prior to surgery to inform eligibility for post-surgery randomization to an adjuvant treatment regimen (NCT06564844). Assay performance was previously reportedin the Journal of Thoracic Oncologyand presented at the 2023 North America Conference on Lung Cancer. In 2022, GRAIL announced a broad strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic (CDx) assays for use with AstraZeneca's therapies. GRAIL is committed to leveraging its blood-based methylation testing for patient care by developing fit-for-purpose diagnostics to enable precision oncology strategies with biopharma partners. Reported Earnings • Nov 13
Third quarter 2024 earnings released Third quarter 2024 results: US$3.94 loss per share. Net loss: US$125.7m (flat on 3Q 2023). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in Europe. Aankondiging • Oct 30
GRAIL, Inc. to Report Q3, 2024 Results on Nov 12, 2024 GRAIL, Inc. announced that they will report Q3, 2024 results After-Market on Nov 12, 2024 Aankondiging • Oct 25
GRAIL, Inc. Presents Initial Results from REFLECTION Real-World Evidence Study of Galleri® Multi-Cancer Early Detection (MCED) Test at the Early Detection of Cancer Conference GRAIL, Inc. announced early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri multi-cancer early detection (MCED) test in routine clinical settings. The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC). Overall, the cancer signal detection rate in this veteran cohort was 1.30% (37/2854 participants; 95% CI: 0.94% - 1.78%), which is consistent with other populations that have received the MCED test (0.88%1 and 0.95%2). Among the 37 participants with a Cancer Signal Detected (CSD) at the time of analysis, 28 completed 180 days of follow-up, and of these, 12 cancer diagnoses were confirmed. More than half of the cases were identified at early stages (I-III) and the most common cancer signal of origin prediction was lung cancer (7). A positive predictive value (PPV), meaning that the test accurately detects a signal for cancer in someone that has cancer, was 42.9%, which is consistent with PPVs from previous Galleri testing datasets. Additional cancers could be diagnosed during the remainder of the one-year follow-up period. The REFLECTION study (NCT05205967) is a multi-center, prospective, non-interventional, cohort study designed to understand the real-world experience of Galleri in clinical settings. This initial analysis included data from seven VA sites with 180 days of post-test follow-up. A total of 2,924 veterans were enrolled in the study at the time of the analysis and 2,854 are analyzable in these initial study data. Within the veteran cohort with data, 70% of participants had been exposed to one or more toxic environmental or occupational hazards during their service, including open burn pits/airborne hazards, Gulf War-related exposures, Agent Orange, radiation and others. The study included recruitment of veterans aged =22 years. The mean age of the cohort was 60 years old and the cohort was 79% male. Aankondiging • Oct 24
GRAIL, Inc. Announces the Appointment of Sarah Krevans to Its Board of Directors GRAIL, Inc. announced the appointment of Sarah Krevans to its Board of Directors, effective immediately. Ms. Krevans will also serve as a member of the Board’s Audit Committee, Compensation Committee, and Nominating and Governance Committee. Following the appointment of Ms. Krevans, the Board will be composed of five directors, four of whom are independent. Ms. Krevans served as president and CEO of Sutter Health from 2016 to 2022. She was responsible for Sutter Health’s integrated network of 14,000 clinicians, 24 hospitals, outpatient services, research facilities, and home health and hospice care. Under her leadership, Ms. Krevans advanced clinical programs, innovation, and digital health to make healthcare more accessible for patients. Previously, Ms. Krevans served as chief operating officer, and regional executive officer and president of the Sutter Health Sacramento Sierra Region. She also held executive roles at Kaiser Permanente and served as deputy director of Maine’s Bureau of Medical Services and acting director of Medicaid, health planning and licensure programs. Ms. Krevans’ experience as a board member includes serving on many not-for-profit boards and as Chair of the California Association of Hospitals. She currently serves on the board of the Acacium Group and is the incoming Chair of CaringBridge. Ms. Krevans earned master’s degrees in business administration and in public health from the University of California, Berkeley, and a bachelor’s degree from Boston University. Ms. Krevans will serve as a Class II director, for a term expiring at the annual meeting of stockholders to be held in 2026 or until her earlier death, resignation or removal. Recent Insider Transactions • Oct 20
CEO & Director recently sold €1.6m worth of stock On the 15th of October, Robert Ragusa sold around 123k shares on-market at roughly €12.86 per share. This transaction amounted to 51% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Robert's only on-market trade for the last 12 months. Aankondiging • Sep 03
European Court of Justice Rules in Favor of Illumina, Inc. in Relation to Relation to the European Commission's Acquisition of GRAIL Illumina, Inc. announced that it welcomes the European Court of Justice's (ECJ's) judgment ruling that the European Commission did not have jurisdiction over Illumina's acquisition of GRAIL. Judgment confirms Illumina's longstanding view that the European Commission exceeded its authority by asserting jurisdiction over this merger. The basis for the 432 million euro fine has now been removed and will no longer be payable. Following Illumina's spin-off of GRAIL in June 2024, GRAIL is now an independent public company. Illumina maintains a minority share of 14.5% in GRAIL, and Illumina will continue to support the company with its sequencing technology and suite of services. In the US, the FTC Commissioners dismissed the case against Illumina and GRAIL on August 15, 2024, following the successful spinoff of GRAIL, thus ending the U.S proceedings. Aankondiging • Aug 30
GRAIL, Inc. Announces Results of Galleri Multi-Cancer Early Detection Blood Test in Prostate Cancer Published in JCO Precision Oncology GRAIL, Inc. announced that detailed findings of the performance of its Galleri multi-cancer early detection (MCED) test in prostate cancer were published in JCO Precision Oncology. The data support the clinical performance of the Galleri test to preferentially screen for aggressive, clinically significant prostate cancer as compared to slow-growing (indolent) cases in the Circulating Cell-free Genome Atlas (CCGA) and PATHFINDER studies. The published data is from an analysis of 420 prostate cancer patients identified in the independent clinical validation portion (substudy 3) of the multi-center, case-control observational study Circulating Cell-freeGenome Atlas (CCGA) study and 18 cases from the prospective intended-use PATHFINDER study. The data were previously presented at the American Association for Cancer Research (AACR) Annual Meeting in March 2024. Results from this analysis showed that of the prostate cancers that were detected by the MCED test, most were clinically significant (93% were intermediate or high grade and 67% were stage III or IV). For detected prostate cancers, the cancer signal of origin (CSO) prediction accuracy was > 90%. Detectability for stage I and II cancers were 4.2% across both studies combined, which is expected with low shedding prostate cancer tumor fraction and is consistent with cfDNA literature in prostate cancer. Test sensitivity of prostate cancer for all stages was 11.2% in substudy CCGA-3. Notably, the MCED test detected no low-grade cancers, 1.9% of intermediate-grade cancers, and only 4.2% of stage I and II cancers across both studies combined. Of the detected cases, 93% were Gleason grade groups 3-5. This analysis demonstrates the MCED test preferentially detects high-grade, clinically significant prostate cancer. This is important because an MCED test, when used in addition to standard-of-care screening, should not exacerbate overdiagnosis of indolent cancers. These findings also suggest that individuals with a cancer signal detected and a prostate CSO prediction should undergo a prompt diagnostic evaluation to determine the presence of aggressive disease for which treatment is generally indicated. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri 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 requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. false-positive prostate cancer is expected to detect cancer signals, and the cancer signal is located. Recent Insider Transactions • Aug 23
President recently sold €1.1m worth of stock On the 21st of August, Joshua Ofman sold around 74k shares on-market at roughly €14.60 per share. This transaction amounted to 51% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Joshua's only on-market trade for the last 12 months. Aankondiging • Aug 14
GRAIL, Inc. Reports Impairment Charges for the Second Quarter Ended June 30, 2024 GRAIL, Inc. reported impairment charges for the second quarter ended June 30, 2024. For the quarter, the company reported goodwill and intangible impairment of $1,420,936,000. Reported Earnings • Aug 14
Second quarter 2024 earnings released Second quarter 2024 results: US$51.06 loss per share. Net loss: US$1.59b (flat on 2Q 2023). Aankondiging • Aug 01
GRAIL, Inc. to Report Q2, 2024 Results on Aug 13, 2024 GRAIL, Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 13, 2024 Aankondiging • Jul 15
GRAIL, Inc. Provides an Update on the PATHFINDER 2 and NHS-Galleri Registrational Clinical Trials Evaluating the Galleri® Multi-Cancer Early Detection (MCED) Test GRAIL, Inc. provided an update on the PATHFINDER 2 and NHS-Galleri registrational clinical trials evaluating the Galleri® multi-cancer early detection (MCED) test. GRAIL has completed the PATHFINDER 2 study's planned enrollment of more than 35,000 participants who are eligible for guideline-recommended cancer screening at more than 30 healthcare institutions in North America. In addition, GRAIL has completed the third and final round of study visits for the NHS-Galleri trial, which enrolled more than 140,000 participants. The PATHFINDER 2 and NHS-Galleri studies will significantly expand the company's existing clinical validation and performance evidence for the Galleri test. By supplementing robust clinical evidence program with more than 35,000 participants in the U.S. for PATHFINDER 2 and over 140,000 participants in England for NHS-Galleri, the company will continue generation of additional performance, safety, and clinical utility data," said Bob Ragusa, Chief Executive Officer at GRAIL. "Both studies were designed to enroll a diverse participant population, representative of socio-economic, ethnicity, gender and age differences, and the company is proud of the diversity of the study populations. The data from these studies, as well as supplemental data from other clinical studies, will support premarket approval application submission for Galleri to the FDA, which is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. The company looks forward to seeing results from the first 25,000 individuals enrolled in the PATHFINDER 2 study in the second half of 2025 and final results from the NHS-Galleri trial in 2026. 
