Latest news with #MCED
Yahoo
8 hours ago
- Business
- Yahoo
Harbinger Health Showcases Multi-Cancer Early Detection Performance in High-Risk Populations at ASCO 2025
Reflex blood-based multi-cancer early detection (MCED) test demonstrated clinically meaningful per-cancer Positive Predictive Value (PPV) and early-stage sensitivity for multiple cancers with elevated incidence and mortality in a high-risk population Data to be presented at ASCO's Clinical Science Symposium on the future of cancer detection CAMBRIDGE, Mass., May 31, 2025 (GLOBE NEWSWIRE) -- Harbinger Health, a biotechnology company pioneering the detection of early cancer, today announced clinical data demonstrating the performance of its blood-based MCED test across multiple high-incidence, high-mortality cancers, including those disproportionately affecting individuals with obesity, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Results highlight the potential of Harbinger's ctDNA-methylation-based assay and reflex testing paradigm to address gaps in population-level early cancer detection, particularly for cancers without established screening programs, and in high-risk patient populations with limited clinical guidelines. 'The results from our study demonstrate the robust early-stage performance of our test across multiple cancer types. While the obesity-associated subset demonstrates our ability to target high-risk groups, the broader results underscore the platform's potential across a wide range of deadly cancers that lack mechanisms for effective, large-scale early detection via routine screening,' said Hutan Ashrafian, M.D., Ph.D., M.B.A., Chief Medical Officer of Harbinger Health. 'The analysis that we are presenting at ASCO validates the alignment between our test performance and disease burden and reflects our commitment to designing a test for those who need it most, when it matters most.' Harbinger's test uses specific proprietary methylation patterns of cell-free ctDNA in blood to detect the presence of cancer. The company has developed a platform that combines unique insights into the biology of cancer's origin with artificial intelligence and analytical and methodological innovations to create novel diagnostic and screening products in multiple clinical settings and cancer indications. Harbinger's reflex test system uses a two-step approach. The primary methylome profiling test is optimized for high sensitivity to rule out disease. This is followed by a confirmatory reflex test with an expanded methylation panel designed to improve PPV, rule in the presence of cancer, and identify tissue of origin (TOO). Harbinger conducted the Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study (NCT05435066) with Sarah Cannon Research Institute to validate and further develop Harbinger's platform. The multi-center, case-controlled study enrolled approximately 8,095 subjects from 126 sites across the U.S. and included two groups: a cancer group of treatment-naïve patients with confirmed diagnoses across 20+ solid and hematologic tumor types, and a non-cancer (control) group of individuals without suspected cancer at enrollment. All participants provided a single blood sample, and controls were followed for one year to confirm their cancer-free status. Dax Kurbegov, M.D., Senior Vice President at HCA Healthcare Sarah Cannon Cancer Network, will present the findings from the obesity cohort of the CORE-HH study at a Clinical Science Symposium entitled 'The Future of Cancer Detection is Coming' from 8:00-9:30 a.m. CDT on Saturday, May 31, 2025, in Hall D1 of the McCormick Place Chicago Convention Center. Key highlights from the presentation include: The test cohort, consisting of 762 individuals with obesity, was assembled from the CORE-HH study and had a mean age of 57.1 ± 13.4 years and were 63.3% female, 22.4% Black or African American, and 67.8% White. The distribution of cancer types evaluated in this study was breast, uterine, lung, lymphoid-line, prostate, colorectal, pancreas, upper GI (includes esophageal, esophagogastric junction, and gastric), head and neck, liver, biliary tract, and others. Cancer types grouped under 'Others' were not used to train the TOO model due to low sample counts. These include ovarian, renal, anal, neuroendocrine, cervical, melanoma, bladder, myeloid, soft tissue, sarcoma, among others. At 98.3% specificity, the reflex test achieved conventional sensitivities of 25.8% for early-stage (I-II) cancer and 80.3% for late-stage (III-IV) cancer. At 98.3% specificity, the reflex test achieved a conventional sensitivity of 50.9% for cancers without a screening program in the U.S. general population. Cancers with screening programs in the U.S. general population that were excluded are breast, colorectal, lung, prostate, and cervix. Overall intrinsic accuracy - the proportion of correct TOO readouts among cases with a corresponding readout category - was 36%. TOO-specific performance as measured by PPV for the following cancers was hepatobiliary (15%), upper GI (22%), colorectal (33%), and lung cancer (25%). In a modeled 100,000-person cohort, the test identified 51 of 86 pancreaticobiliary cancers, including 8 of 31 at early-stage. Dr. Kurbegov commented: 'These data introduce for the first time a metric for intrinsic accuracy to measure a test's ability to correctly identify both a cancer signal and its tissue of origin. This is a more stringent and clinically relevant result as compared to conventional sensitivity, which has been the current industry standard and does not provide information on the location of cancer within an individual. Measuring per-cancer PPV, combined with the reflex test design, are novel aspects of Harbinger's approach that may support stratified diagnostic and follow-up strategies that could help physicians tailor downstream evaluation and management according to the likely tissue of origin and associated benefit-risk considerations. These advances solve some of the most confounding challenges we currently face in our ability to make the most of blood-based tools for early cancer detection. Given these technological advances and study results, I am optimistic that the future of cancer detection is bright and close at hand.' Obesity is estimated to contribute to ~84,000 new cancer cases in the U.S. annually1,2, and the incidence of obesity-related cancers has increased substantially over the past two decades3. Thirteen obesity-associated cancers represent ~40% of cancer diagnoses in the U.S.4, and most of these cancers, such as pancreatic, liver, and endometrial, do not have screening programs available. About Harbinger Health Harbinger Health is leading a transformation in early cancer detection, introducing fundamentally new approaches to screening, diagnosis, and management. The company combines advances in artificial intelligence with proprietary insights into the biology of the beginnings of cancer to identify cancer before it is visible or symptomatic with the aim of developing a low-cost, multi-cancer blood test. Harbinger envisions a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies. Harbinger was founded by Flagship Pioneering after three years of foundational research in its Labs unit and launched in 2020. Learn more about Harbinger by visiting or following us on LinkedIn. Media Contactpress@ ______________________________________ American Association for Cancer Research. Cancer Progress Report 2024 Ligibel JA, Alfano CM, Courneya KS, et al. American Society of Clinical Oncology position statement on obesity and cancer. J Clin Oncol. 2014 Shiels MS, Haque AT, González AB et al. Trends in Cancer Incidence and Mortality Rates in Early-Onset and Older-Onset Age Groups in the United States, 2010–2019. Cancer Discovery. 2025 National Cancer Institute. Obesity and Cancer Fact Sheet. Updated 2022Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
3 days ago
- Health
- Cision Canada
Geneseeq's Breakthrough Cancer Detection Blood Test Published in Nature Medicine
Large-Scale Study Confirms CanScan ® Test Accurately Detects Early-Stage Cancers From a Simple Blood Draw TORONTO, May 28, 2025 /CNW/ - Geneseeq is proud to announce the publication of results from its large-scale multi-cancer early detection (MCED) study in Nature Medicine, one of the world's leading peer-reviewed medical journals. The publication presents findings from the DECIPHE-Omnia Study (Detecting Early Cancer by Inspecting ctDNA Features), a landmark effort evaluating CanScan ®, Geneseeq's advanced blood-based test for early cancer detection. Innovation Behind CanScan ® CanScan ® is a non-invasive blood test powered by AI-driven whole-genome sequencing. It analyzes subtle cancer-specific changes in circulating cell-free DNA (cfDNA) using Geneseeq's proprietary MERCURY TM Technology. By integrating fragmentomics, genomic, and epigenomic features, the test identifies whether a cancer signal is present and accurately predicts the tissue of origin (TOO). In 2023, CanScan ® received Breakthrough Device Designation from the U.S. FDA. A New Way to Catch Cancer Early Unlike traditional cancer screening tools that are limited to one type of cancer and often involve invasive procedures, CanScan ® offers a convenient, comprehensive solution: a single blood test that screens for more than a dozen cancers at once. In the study: CanScan ® detected early-stage cancers with high accuracy Identified cases missed by routine physical exams Produced a low false-positive rate, helping reduce unnecessary follow-ups "This study brings us closer to making routine multi-cancer screening a reality," said Dr. Yang Shao, CEO of Geneseeq. "Our vision is a future where a simple blood test can help save lives through earlier diagnosis." The Landmark DECIPHER-Omnia Study The DECIPHER-Omnia Study is a multi-phase clinical research program involving more than 8,000 participants to date across three stages: Test development and training using samples from cancer patients and healthy donors Independent clinical validation in a separate cohort A large-scale ongoing screening study in asymptomatic individuals aged 45–75 (the JINLING cohort) The newly published Nature Medicine paper presents interim findings from over 3,700 participants in the JINLING cohort. Key Interim Results: Specificity: 98.1% Sensitivity: 53.5% across all detected cancers; 62.1% for targeted cancer types Early-stage detection: 93% of confirmed cases were Stage 0, I, or II Positive Predictive Value (PPV): 25% — 10 times higher than standard screening (2.2%) Low false positives: Reduced unnecessary follow-up procedures Detection of missed cancers: CanScan ® identified 53.3% of cancers overlooked by standard screening Looking Ahead The JINLING cohort study has now successfully completed enrollment of its target 15,000 participants and is currently in the follow-up and data analysis phase. The complete dataset, along with ongoing monitoring, is expected to provide deeper insights into the real-world utility of CanScan ® for population-level cancer screening. Geneseeq Technology Inc. is a research-driven global leader in precision oncology, pioneering next-generation sequencing (NGS) technologies to transform cancer detection, diagnosis, and treatment. Its portfolio includes comprehensive genomic profiling for all tumor types, cancer-specific panels, minimal residual disease (MRD) monitoring, and multi-cancer early detection (MCED) solutions. Geneseeq has achieved several key regulatory milestones, including CE-IVD certification for its solid tumor and hematologic cancer panels, CE mark and FDA Breakthrough Device Designation for its MCED test, CanScan ®, and NMPA approval for two NGS-based IVD kits in lung cancer, including tumor mutational burden (TMB) detection. With headquarters in Canada and China, Geneseeq operates CAP- and CLIA-certified laboratories and partners with hospitals, research institutions, and pharmaceutical companies worldwide to advance precision medicine.
Business Wire
22-05-2025
- Health
- Business Wire
Exact Sciences Highlights Innovations in Early Cancer Detection and Precision Oncology at ASCO 2025
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced it will present ten abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30–June 3, 2025, in Chicago, Ill. Presentations include new data on the Oncodetect™ molecular residual disease (MRD) test, multi-cancer early detection (MCED) testing, the Oncotype DX Breast Recurrence Score® test, and the Cologuard® test that underscore Exact Sciences' expanding portfolio and commitment to advancing care through scientific excellence. 'The data Exact Sciences will present at ASCO 2025 reflect the scientific rigor and clinical significance of our expanding portfolio and pipeline,' said Dr. Rick Baehner, MD, chief medical officer, Precision Oncology at Exact Sciences. 'From MRD to MCED to CRC screening, we are advancing evidence-based innovations that help empower providers and deliver crucial answers to patients. Every study, partnership, and data point move us closer to a future where cancer is detected earlier and treated with greater precision.' Real-world evidence supporting the Cologuard test continues to grow, with ongoing research into repeat screening. New data from prominent experts and research groups reinforce the Oncotype DX® test as a trusted, evidence-backed tool, further affirming its role as the standard of care for predicting chemotherapy benefit for breast cancer patients. Building on more than a decade of experience with Cologuard and 20 years of leadership with the Oncotype DX test, Exact Sciences continues to advance the future of precision oncology and multi-cancer screening. New Data and Continuous Evidence Generation Underscore the Oncodetect Test's Power to Detect Cancer Recurrence. Data from the Beta-CORRECT study further strengthens the clinical foundation of the Oncodetect test, confirming its role in helping guide treatment decisions and surveillance strategies for patients with stage II–IV colorectal cancer1. Expanding on this evidence to multiple solid tumor types, Exact Sciences and Flatiron Health continue enrollment in a multi-year, prospective study evaluating how MRD testing can improve cancer monitoring and treatment decisions in community care settings. New Data Support Promise of MCED as Exact Sciences Prepares for LDT Launch. A modeling study found annual MCED testing could reduce late-stage cancer incidence by more than 40% and mortality by up to 18% in high-risk groups2. Additionally, the Falcon registry, a large, prospective real-world study of Exact Sciences' MCED test, will track 25,000 participants against a 50,000-person standard-care cohort to assess adoption, outcomes, and patient experience. These findings come as Exact Sciences prepares to launch Cancerguard™ EX, its MCED lab-developed test (LDT), in the second half of the year, marking a significant step in expanding access to earlier cancer detection. Exact Sciences abstracts at ASCO include: Precision Oncology The Association of Circulating Tumor DNA (ctDNA) with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT Study Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3590 Molecular Residual Disease (MRD) in Solid Tumors Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: TPS3186 Enhancing Recurrence Detection in Stage III Colorectal Cancer Patients Through Molecular Residual Disease Test-guided Surveillance: A Modeling Study Abstract number: e15600 Patient outcomes in WSG-ADAPT according to NATALEE and MonarchE risk criteria Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 601 Screening Adherence to repeat screening for colorectal cancer using the multi-target stool DNA test: Real-world analysis of patients from Federally Qualified Health Centers Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3630 A decade of progress: Trends in 5-year survival across 17 cancer types Abstract number: e23262 The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: 10542 Falcon – Exact Sciences' multi-cancer early detection (MCED) real-world evidence (RWE) registry Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: TPS11189 Evaluation of plasma methylated DNA markers for detection HPV-positive oropharyngeal squamous cell carcinoma: a case control study Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 6057 Feasibility of vaginal tampons versus vaginal swabs in the collection of vaginal fluid for endometrial cancer testing Abstract number: e17617 References Hashimoto et al. The association of ctDNA with recurrence in patients with stage II-IV colorectal cancer: The β-CORRECT study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. Chhatwal, J., Xiao, J., ElHabr, A., Tyson, C., Cao, X., Raoof, S., Fendrick, A. M., Ozbay, A. B., Limburg, P., Beer, T. M., Deshmukh, A., & Briggs, A. (2025). The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype DX® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. NOTE: Oncotype DX Breast Recurrence Score and Oncodetect are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Cancerguard are trademarks of Exact Sciences. Forward-Looking Statement This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding the performance characteristics and health care benefits of the Cologuard, Oncotype DX Breast Recurrence Score, Oncodetect, and Cancerguard EX tests in a commercial setting, as well as statements regarding the development and commercialization of Exact Sciences' pipeline tests. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Yahoo
14-05-2025
- Business
- Yahoo
Q1 2025 Grail Inc Earnings Call
Harpal Kumar; President Biopharma & Europe; Grail Inc Joshua Ofman; President; Grail Inc Aaron Freidin; Chief Financial Officer; Grail Inc Robert Ragusa; Chief Executive Officer; Grail Inc Subbu Nambi; Analyst; Guggenheim Partners Tejas Savant; Analyst; Morgan Stanley Doug Schenkel; Analyst; Wolfe Research Kyle Mikson; Analyst; Canaccord Genuity Harpal Kumar (technical difficulty)-- performance of Galleri. As a reminder, Galleri demonstrated specificity of 99.5% and a CSO accuracy of 88% in Pathfinder. There were no serious safety concerns in the NHS Galleri prevalent screening round. As Bob mentioned, the top line results from the prevalent screening round of the NHS Galleri trial are very of all the three years of the trial are expected in mid 2026. These longitudinal results will be the first clinical utility results of their kind in the MCED field. The NHS Galleri trial was designed as three annual blood draws plus 12 months of follow-up in order to evaluate Galleri's ability to diagnose cancer at an earlier stage relative to standard of care. Cancer screening trials designed to show clinical utility are commonly conducted over three or more years using an annual screening if screening is only conducted once, results can be influenced by the fact that the first screening round detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed. This and other factors are likely to cause final results of the three-year trial to differ from a review of the first round results. NHS Galleri is the largest and only randomized control trial of any MCED test, and the results thus far demonstrate strong Galleri with England's NHS, we expect to publish detailed data from the ongoing NHS Galleri trial, including the primary endpoint of an absolute reduction in the number of stage three and four cancer diagnoses as well as a number of test performance secondary endpoints, including episode sensitivity in mid with that, I'll now hand over to Josh. Joshua Ofman At GRAIL, we have implemented one of the largest clinical evidence programs in the MCED space, with more than 385,000 participants than 21,000 participants were included in the studies to support the development and launch of Galleri, and over 170,000 individuals are included in our registrational studies which support our PMA submission to the let's be clear, Galleri is working in the real world. We are detecting clinically meaningful cancers and early-stage cancers in asymptomatic adults. Our signal detection rate in commercial use is very much in line with what we expected based on our prior clinical studies. The majority of the early-stage cancers Galleri has found are in cancer types where a recommended screening test does not even exist, thereby allowing patients an opportunity to access more effective and even curative we've described over time the key performance metrics, features and capabilities for multi-cancer early detection tests, which importantly are quite different from those for single cancer screenings. Positive predictive value or PPV is a key metric which discerns among positive test results how many are true critically important, defines the false positive rate. A very low false positive rate helps reduce unnecessary workups and their associated costs and contributes to driving a high positive predictive value. Our demonstrated specificity at 99.5% equates to a false positive rate of 0.5%. So just to remind you, a 1% reduction in specificity to 98.5%, that is a 0.5% false positive rate, would then become a 1.5% false positive rate three times applying this to a real-world population of a million people tested, instead of there being only 5,000 false positives, there would now be 15,000. Such a reduced specificity would be expected also to result in a positive predictive value, about half of what we see at a specificity of 99.5% holding all other metrics one of the most important features of a multi-cancer early detection test is the ability to localize that cancer signal. In multi-cancer early detection, CSO capability or a cancer signal of origin prediction, is the key to guiding physicians to an appropriate and efficient workup to diagnosis. We consistently hear from physicians in the field that this is a critical component of any multi-cancer screening an FDA advisory committee on multi-cancer detection in November '23 similarly emphasized the importance of a cancer signal of origin feature in any multi-cancer detection teams have continued to present evidence demonstrating Galleri's performance at renowned medical conferences. In April, at the AACR meeting, we shared a real world data set on Galleri's test performance and implementation in over 100,000 individuals. Galleri indeed identified cancers across this large intended use population, including early-stage cancers, and cancers without recommended the test performance in this real-world setting remained consistent with what we've consistently observed in our prior clinical studies. Among other data we also presented at AACR in analysis highlighting the importance of annual screening with an MCED test, model data of post-test probabilities of cancers for individuals receiving MCED tests showed that individuals receiving a negative MCED test, and they have a reduced risk of late-stage cancer diagnosis for one year after the blood draw. And then this risk increases as the screening interval extends beyond one year. This study really supports the need for annual I'd like to highlight that US health systems are now publishing their own experiences with Galleri performance and implementation. A paper authored by the Mayo Clinic and published recently in March in the Journal of Primary Care and Community Health showed that Galleri effectively detected cancers in an asymptomatic population within their healthcare system and had a 73% positive predictive value. In other words, 73% of those with a positive Galleri test yielded a confirmed new cancer the sample in this Mayo Clinic analysis was relatively small and had some different patient demographics compared to our prior trials. Importantly, this paper included the Mayo Clinic's standardized approach to pursue a diagnostic workup following a positive cancer signal and our signal of origin outline steps are informed by a multidisciplinary expert counsel convened by the Mayo Clinic. Then they reviewed our cancel signal of origin prediction and other data from our first Pathfinder trial. These recommendations continue to be updated, and they've really served as a centralized resource for the Mayo Clinic additional health systems and clinicians are beginning to publish their experience with Galleri. Upcoming ASCO 2025 presentations of note include the implementation and evaluation of multi-cancer early detection testing at the Dana-Farber Cancer Institute, a retrospective analysis of clinical outcomes and diagnostic pathways. And an independent analysis by Alabama Cancer Care, titled A Clinical Review of a Novel Blood Test Use in Rural Alabama for Multi-cancer Detection Analyzing methylation patterns of Cell-free DNA and Future looking forward, we anticipate performance data from the first 25,000 participants in our other registrational study, Pathfinder 2, later this year. We also plan to conduct a bridging study between the version of Galleri used in our registrational trials, NHS Galleri and Pathfinder 2, to the updated version that we plan to submit to the FDA for pre-market approval. We plan to submit data from the prevalent screening round of the NHS Galleri trial. The first 25,000 participants in the Pathfinder II study and the bridging study as part of our pre-market approval application in the first half of '26.I'll now hand it over to Aaron for a review of our financials. Aaron Freidin Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the first quarter. First quarter results were strong, with revenue of $31.8 million up $5.1 million or 19% as compared to the first quarter of revenue for the quarter is comprised of $29.1 million of screening revenue and $2.7 million of development service revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy see continued demand for our Galleri test, and sold more than 37,000 tests in the first quarter, a period we have observed historically to be softer relative to the fourth quarter. Repeat test volumes have moved higher over time, including in early 2025. More than 20% of Galleri volume today is repeat testing. Screening revenue of $29.1 million in the first quarter was up 24% as compared with the first quarter of Galleri revenue was $28.7 million up 22% compared to the first quarter full year guidance we shared in January of US Galleri revenue growth of 20% to 30%. We do not expect major impacts from tariffs on our current business as our laboratory is located in the US and a significant majority of our suppliers are located in and manufactured in the loss for the quarter was $106.2 million an improvement of 51% as compared to the first quarter of 2024. And included amortization of intangible assets of $34.6 million and stock-based compensation of $16.2 adjusted gross profit for the first quarter of 2025 was $14.3 million, an increase of $2.3 million or 19% as compared to the first quarter of 2024. We ended the quarter with a cash position of $677.9 million. In January, we guided that we expect cash burn for the full-year 2025 to be no more than $320 million. This represents a decrease of more than 40% compared to 2024. Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones. Robert Ragusa Thank you, Aaron. To close, we remain encouraged by the demand we are seeing today while we advance towards major milestones, seeking FDA approval of Galleri and pursuing broad are very pleased to have taken additional strides in early 2025, including executing on the transition to the enhanced, more scalable version of Galleri, achieving Tricare coverage, and enabling easier access to Galleri ordering through Quest Diagnostics and Athena ahead, we expect to share interim data from Pathfinder to study in late 2025, that the data set will include the first 25,000 of the 35,000 participants enrolled. In 2026, key milestones include the completion of our modular PMA submission to the FDA in the first half and final results from our 140,000 participant NHS Galleri that will turn the call over to Q&A operator, please go ahead. Operator (Operator Instructions)Subbu Nambi, Guggenheim Partners. Subbu Nambi Hey, guys. Thank you for taking my question. My first question is back in December, the new version of Galleri was starting to be offered with expected short term variable cost improvement. Can you quantify what those were in the quarter and what should be -- Aaron Freidin Yeah, so as you said, we did launch at the end of last year. This year, the first quarter we're on that new version, and we'd expect to see margins continue to improve over the rest of the year as we increase scale and just work through the launch transition that we're going through this quarter. As you said, you'll see those variable COGS and improvements come over time as we move everything over to that, the new version completely. Subbu Nambi Got it. And then, when setting guidance, you said you considered Quest and said legislation and Tricare approval. How have those played out to your expectations in 1Q and then is there any upside from here more than what you expected? Robert Ragusa Yeah, so, early days on both Quests as well as Tricare, so we are seeing improved ordering from Quest providers that are going through the Quest portal. So that's very encouraging, but again, early days on that and Tricare, we're working through the contracting process. So we're we're in coverage with Tricare, but working through the coverage process process with the various contractors there. So more to come on that later in the year. Subbu Nambi Got it. Thank you, guys. Operator Tejas Savant, Morgan Stanley. Tejas Savant So maybe, just one on the cash born in the quarter, I guess, can you help us just think about the burn trajectory over the course of the next, between now and your end, how you're tracking towards that sort of $320 million or less than born target that you guys had?And then second, on sort of a related note, you we've got a couple of, other MCED launches coming up here, including one from, an established brand in single cancer screening. So how are you thinking about your OpEx levels, which you've done a good job sort of controlling, so as to keep the burn down? You need to sort of, think about re-accelerating it a little bit as as some of those other offerings. Aaron Freidin Yeah, on the cash burn, so I think we burn just under $90 million first quarters, the period that we pay out our annual bonus from the prior year, which is something of course not going to repeat in the future quarters. And also as we talked about margins, just the last question, as we grow more and as margins improve, the cash burden will be in the $320 million range that we gave. Robert Ragusa OpEx and competitors, so it's good actually to see, others investing in multi cancer early detection. As we, I think we've noted on this call where we've been doing all the heavy lifting in terms of really educating the field of developing the market. We've made unprecedented investments though to set a very high bar for the field and demonstrated a really strong specifications based on that. And so we'll have to take a look and see, from the announcements, what actually transpires in terms of actual competitive approaches to see if that's going to have any OpEx impacts on us. So right now, I would say it's not clear that we have OpEx impacts from those launches, but something we'll monitor over the next couple quarters. Tejas Savant Got it, fair enough. And then a couple of quick cleanups on the data side, guys. So the intervention arm, from the NHS Galleri, that data that you just shared, how should we be thinking about the read across from that your, next year's final NHS Galleri readout, like, particularly in terms of that higher PPV you highlighted? And can you put a finer point on, when in the second half of the year we can expect Pathfinder 2 data? Robert Ragusa Yeah, so on the second question, really looking to mid mid next year to have the readout on the full three-year study. We also have Harpal on the call today, so Harpal may be answering the first part of that question. Harpal Kumar Yeah, sure, thank you for the question. So look, it's important just to reiterate that the results we've shared today are from the first screening round only. And as we've tried to describe, it's really important that the first round of a screening program, what you typically see is that you are finding a lot of prevalent cancers in the population that have not yet been are asymptomatic, but they can often be very late stage. And so as we go through to the second and third rounds, and those prevalent cancers in the population have already been diagnosed, we would expect to see some differences in the second and third round as indeed has other screening programs in the past. But we're not in a position today to be able to predict what those results will be, but we will have those results in mid '26. Operator Doug Schenkel, Wolfe Research. Doug Schenkel Hey, good afternoon, everybody. Thank you for taking my questions. I want to talk about two things, the BMJ publication, and then I want to talk about your cash management strategy, which, is obviously top of mind for a lot of starting on the BMJ publication. As you talked about in your prepared remarks, you demonstrated that annual MCED screening shows a higher projected impact on stage shift and mortality reduction relative to biennial testing. So keeping that in mind and then also the fact that you've indicated that based on draft MCED legislation that you would assume that ASPs would land in the 500 to 550 level, my questions are, do you believe that the ASP would be unaffected by testing interval, meaning if there's more frequent testing, does the ASP need to come down?And then the second part of the question is, when you think about the cost to the system, if there was broad adoption of Galleri at that pricing level, how -- and then you think about by extension how much it would cost to find a single cancer. If we think about the cost for cancer detected, including subsequent workups and even a small number of false positives, would there be any concern in that scenario about the health economics, especially again for an annual test? Robert Ragusa Josh, you want to take that one? Joshua Ofman Sure. So I think as you noted, we have a lot of data to suggest that based on cancer biology, Galleri should be administered on an annual basis, if we want to find early-stage asymptomatic cancer based on the rates with which cancers are progressing, given everything we know, on the biology of circulating DNA we think that's the right way to go, and all of our pricing strategies and everything we've projected about ASP are based on annual testing. So it's really too early to speculate on what would happen if we tested more frequently than that. From the health economic perspective, Doug, it's a great question. We know that with annual testing, even if populations scale, at the prices that are in the market today, let alone the lower ASPs that you're commenting on, this is a highly cost-effective compared to what we're spending today to diagnose a cancer, given everything that's going on with the false positive rates of current single cancer screening, that the cost to diagnose a cancer with an MCED added to standard of care screening comes down substantially. And the numbers needed to screen are much lower than what we've seen traditionally with some of the single cancer screening tests. So even today, the health economic data are very compelling from an efficiency and cost-effectiveness perspective to payers by screening the population for any disease, but it's high value investment. Doug Schenkel Okay, thank you for that. Good food for thought. So the second topic is on cash management. And just keeping in mind your stock, at least last I checked is up, about 140% year-to-date. There are obviously questions about your ability to fund operations through the period where you would plausibly get FDA approval and CMS reimbursement, and again, acknowledging you guys are doing a good job moving towards, trying to extend the runway as long as are still concerns you can get there, especially given where we are with the MCED bill and, the path to FDA reimbursement and the approval and CMS reimbursement. So in a best case, recognizing those developments are several years away and also recognizing the NHS Galleri readout, which is pretty critical, doesn't read out until next year. And at that point, your cash position's going to be below half of what it is today, things start to get a little bit what was the calculus given all of these facts at the board level behind not raising money to de-risk the outlook? It seems like that would have been allow you to maybe play offense a little more aggressively, and to make the NH NHS read out like next year less binary. So simply put, what's the thinking here? What's the rationale to not take some steps? What are we missing? Robert Ragusa Doug, it's a good question. It's something we've obviously thought about. As we've said in, previous discussions, we think that getting through some of these milestones derisks the business and creates value for us. And so, in the calculus, we're looking at, getting through some of these major milestones and knowing that we have the cash runway to get through those was kind of the deciding factor towards waiting until things play out a little obviously, the stock as you mentioned, the stock is up a bit. That actually pushes more in the favor of being able to do something. But we still feel we have, substantial cash runway and we have relatively near-term milestones that will be value creating. Aaron, anything? Aaron Freidin I will just add, I mean, we're less than a year out from our spin as well. We've got just about $700 million on our balance sheet. So Doug, I think it's something that we're going to continue to look at and work about work on and think about with our board. So it's on our minds, but we're in a good position now in our view. Operator Kyle Mikson, Canaccord. Kyle Mikson Thanks guys for the questions. Just on NHS first, just given the data here and the partnership and the study, keep progressing, how are the recent conversations with NHS going and do you, what do you expect they're going to do, I guess, with Galleri commercialization in the country of following the full readout in 2026?And then secondly, for maybe Harpal, on the PPV for the subset here that you provided, is that like a modeled number or is that like a concrete metric? I just want to kind of understand. If it's like how the number should be used and it's like how much materially higher it is compared to like Pathfinder, for example? Thanks. Harpal Kumar Thanks, Kyle. So let me quickly take the second question first. So when we say the PPV was substantially higher in the first round, that's a concrete number. We're not sharing what that number is, but we can say it's substantially higher than the 43% that we saw in Pathfinder. So it's not a model respect to the conversations with the NHS, I mean, just to say that we're in constant dialogue with the NHS and with the National Screening Committee in the UK and with the government in the UK. They are clear that they want to wait to see final results from all three rounds of the study before they will make a decision as to if and when to roll out a screening program in the UK or in England particularly. So I can't give you anything more concrete than that at this point other than to say we're in constant dialogue. Robert Ragusa They are maybe go through a little bit of the why not reveal the numbers right now. Harpal Kumar Yeah, sure. So I mean it's important to reiterate that the NHS Galleri trial was designed as a three-year screening study. In other words, we do three rounds of screening, and that's very common in screening trials and in and in studies of screening because for the reasons that I stated earlier on the call. If you only look at one round of screening, then what you'll typically find in that first round is a lot of prevalent asymptomatic cancers in the population, which can often be late stage but haven't yet been going to a second and third round, you start to see what the impact of a, if you like, a more established or steady state screening program might be. And so it's really important that we safeguard those upcoming readouts and the integrity of the trial as a whole. It's also really important that we safeguard the interests of the participants taking part in the so for all of those reasons, we're not sharing more detailed information at this stage. But we are now getting closer to having the final results middle of next year, and we look forward to sharing all of those both with all of you, but also with the NHS at that time. Kyle Mikson Great, that was super helpful. And on the topic of repeat testing, it sounds like that me remains stable. I think I heard 20%, continues. So when you think about repeat testing, what's an acceptable number at this point, do you like 20%? How do you improve the stickiness and that recurring kind of revenue stream? And then how does movement in that number affect your modeling of like ASP and customer acquisition cost over the medium term? Robert Ragusa Yeah, so first of all, we're very pleased with about 20%, given that we're generally not a reimbursed test. We think it compares very favorably to to reimbursed tests. The 20% mark, we expect to continue to be able to grow that, but we need a little more time on there are belts to figure out exactly where that's going to go. From a -- clearly, from a customer acquisition cost that certainly helps the model being able to have that repeat base, at that significant level, so that is something we are factoring in into our modeling. Operator Thank you. There are no further questions at this time. I will now turn the call back to GRAIL for closing remarks. Robert Ragusa So thank you everyone for joining today's call. Operator Ladies and gentlemen, this concludes the call. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
GRAIL Inc (GRAL) Q1 2025 Earnings Call Highlights: Strong Revenue Growth and Strategic Advances
Revenue: $31.8 million, up 19% compared to Q1 2024. Screening Revenue: $29.1 million, up 24% compared to Q1 2024. Development Service Revenue: $2.7 million. US Galleri Revenue: $28.7 million, up 22% compared to Q1 2024. Net Loss: $106.2 million, an improvement of 51% compared to Q1 2024. Non-GAAP Adjusted Gross Profit: $14.3 million, up 19% compared to Q1 2024. Cash Position: $677.9 million at the end of the quarter. Galleri Tests Sold: More than 37,000 tests in Q1 2025. Repeat Testing: More than 20% of Galleri volume is repeat testing. Warning! GuruFocus has detected 4 Warning Signs with GRAL. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. GRAIL Inc (NASDAQ:GRAL) reported a strong first quarter with revenue of $31.8 million, marking a 19% increase compared to the first quarter of 2024. The Galleri test demonstrated a specificity of 99.5%, equating to a low false positive rate of 0.5%, which is crucial for reducing unnecessary workups and costs. The NHS Galleri trial, the largest randomized control trial of any MCED test, showed encouraging top-line results from its first screening round. GRAIL Inc (NASDAQ:GRAL) has a substantial cash position of $677.9 million, with a cash runway extending into 2028, allowing them to achieve major planned clinical and regulatory milestones. The company has achieved Tricare coverage and has made Galleri more accessible through partnerships with Quest Diagnostics and Athena Health. GRAIL Inc (NASDAQ:GRAL) reported a net loss of $106.2 million for the quarter, despite an improvement of 51% compared to the first quarter of 2024. The company is facing competition from other upcoming MCED launches, which could impact their operational expenses and market position. There are concerns about the health economics of the Galleri test, particularly regarding the cost-effectiveness of annual testing at the current ASP levels. The NHS Galleri trial results are not expected until mid-2026, which delays potential commercialization decisions in the UK. Despite a strong cash position, there are concerns about the company's ability to fund operations through the period leading up to FDA approval and CMS reimbursement. Q: Can you quantify the short-term variable cost improvements from the new version of Galleri launched in December? A: Aaron Freidin, CFO: We launched the new version at the end of last year, and in the first quarter, we expect margins to improve as we increase scale and transition fully to the new version. Variable cost improvements will become more apparent over time. Q: How have Quest and Tricare approvals impacted your expectations for the first quarter, and is there potential upside? A: Robert Ragusa, CEO: It's early days for both Quest and Tricare. We are seeing improved ordering from Quest providers, which is encouraging. For Tricare, we are working through the contracting process, and more updates will come later in the year. Q: Can you discuss the cash burn trajectory and how you're managing OpEx with upcoming MCED launches from competitors? A: Aaron Freidin, CFO: We burned just under $90 million in the first quarter, which included annual bonus payouts. As margins improve, we expect to stay within our $320 million cash burn target. Robert Ragusa, CEO: We are monitoring competitor launches but currently do not anticipate significant OpEx impacts. Q: How should we interpret the NHS Galleri trial results shared today, and when can we expect Pathfinder 2 data? A: Robert Ragusa, CEO: We expect the full three-year study results mid-next year. Harpal Kumar, President Biopharma & Europe: The first round results show prevalent cancers, often late-stage. We expect differences in subsequent rounds, with final results in mid-2026. Q: Regarding the BMJ publication, how does annual MCED screening impact health economics, and is ASP affected by testing frequency? A: Joshua Ofman, President: Annual testing is based on cancer biology and is cost-effective. Current pricing strategies assume annual testing. Health economics are favorable, with lower costs to diagnose cancer compared to single cancer screenings. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
