GRAL

Image source: The Motley Fool. Wednesday, August 5, 2026 at 4:30 p.m. ET Chief Executive Officer - Joshua Ofman Chief Financial Officer - Aaron Freidin Chief Scientific Officer and President, Global Clinical and Medical Affairs - Harpal Kumar Chief Growth Officer - Andrew Partridge Operator: Good day, ladies and gentlemen, and welcome to the GRAIL Second Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin. Unknown Attendee: Thank you, and thank you all for joining us today. On the call are Joshua Ofman, our Chief Executive Officer; Aaron Freidin, Chief Financial Officer; -- sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs; and Andrew Partridge, Chief Growth Officer. I'll remind you that we'll be making forward-looking statements based on current expectations. It's our intent that all statements other than statements of historical fact, including statements regarding our anticipated financial results and commercial activity will be covered by the safe harbor provisions for forward-looking statements under federal securities laws. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and GRAIL assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that GRAIL files with the Securities and Exchange Commission, including the Risk Factors section in GRAIL's most recent annual report on Form 10-K and the quarterly report on Form 10-Q we plan to file for the second quarter of 2026. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit and adjusted EBITDA, which exclude certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of GRAIL's financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is available on our website. With that, we turn to Josh. Joshua Ofman: Thank you. Good afternoon, everybody, and thanks for joining us to review the results of the second quarter 2026 and discuss recent business updates. GRAIL continues to execute across our clinical and commercial priorities. We launched the Galleri test in 2021 after our approximate 6,000 participant interventional PATHFINDER study, which was conducted under an FDA-approved investigational device exemption and read out and demonstrated strong performance and safety in a screening population. For several years, PATHFINDER was the only interventional study that clearly demonstrated the benefits and evaluated the potential harms of deploying an MCED test in the intended use population. Since then, we've read out 2 additional large studies, our 35,000 participant PATHFINDER 2 study in North America and the groundbreaking 140,000 participant NHS-Galleri trial in England, which included 3 annual tests. We recently presented detailed performance, safety and clinical utility results from these studies at the 2026 American Society of Clinical Oncology Annual Meeting, and they are currently under review for publication, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies. These data in the asymptomatic screening population are critical for physicians and patients to understand test performance as case-controlled studies can fail to replicate performance when tests are rolled out in an intended use population. We're extremely proud of the unparalleled performance demonstrated in these studies in the screening population, and we're focused on driving to FDA approval and subsequent Medicare and commercial reimbursement. Galleri test performance is highly differentiated with a false positive rate of less than 0.5%, resulting in at least 3x to 6x fewer false positives than other MCED tests in development. Our technology at GRAIL was designed specifically for population scale MCED screening. Our extensive research published in top-tier journals concluded that methylation holds the highest biological information density, which is why GRAIL's proprietary methylation platform, the largest of its kind, is uniquely capable of delivering high accuracy detection and precise localization. We have published to our knowledge, the largest head-to-head genomic feature comparison study in the entire field. And we showed that combining other approaches considered did not improve performance over our proprietary methylation technology. Adding these other features only introduced additional complexity, cost and biological noise. And the field is increasingly moving to methylation as the technology of choice, further validating our approach. Today in the market with Galleri, we continue to expand access through new and existing partnerships, and we are accelerating our international expansion activities. Related to that, in the second quarter, we completed the previously announced $110 million financing with Samsung. Alongside that closing, we began work with Samsung C&T Corporation on our strategic collaboration. As a reminder, we and Samsung C&T Corporation will work together to commercialize the Galleri test in South Korea with the potential to expand into additional Asian markets, including Japan and Singapore. The $110 million investment in GRAIL represents a long-term investment to support our growth and international goals. We were very pleased to complete this financing, and we look forward to moving forward with Samsung to introduce our MCED technology to patients throughout Asia. In the U.S., we continue to see growing physician adoption of the Galleri test. We sold over 61,000 Galleri tests in the second quarter, a 35% increase in volume year-over-year. Total Galleri screening revenue was $42.6 million, up 24% over the year prior. For the first half of 2026, we saw Galleri test revenue growth of 30% year-over-year to more than $80 million and Galleri test volume growth of 42% to more than 117,000 tests. We announced early in 2026, the planned expansion of our field sales and medical teams based on the positive performance and clinical utility results observed in our PATHFINDER 2 and NHS-Galleri trials. This expansion was substantially complete at the end of the second quarter. New personnel have been onboarded and trained and are now in the field and initial feedback from sales force engagements with physicians since ASCO has been really positive. Last month, we announced a collaboration with Priority Health to enable its employer groups to add the Galleri test to their existing screening coverage. Priority Health is a nationally recognized nonprofit health plan with more than 1.4 million members in Michigan and nearby states. Priority Health launched coverage for Galleri within certain plans in 2025, and our collaboration announced in July marks a promising expansion of this partnership. Moving to our clinical evidence base. We recently shared strong clinical utility, performance and safety results from our NHS-Galleri trial and PATHFINDER 2 studies at the recent ASCO Annual Meeting in May. Although the primary endpoint for the NHS-Galleri trial of a combined reduction of Stage III and IV cancers was not met, we believe the other results of the study demonstrated very strong performance, safety and utility. Across both studies, adding Galleri to standard of care increased the cancer detection rate by 4x to 6.5x. The Galleri test demonstrated very consistent performance with a false positive rate of less than 0.5% and positive predictive values ranging from 50% to 60% Galleri also demonstrated high accuracy in predicting cancer signal of origin, enabling efficient and patient-centered diagnostic evaluations. Today, standard of care screening finds only about 14% of cancers in the U.S. and about 6% of cancers in the U.K. By adding Galleri, we estimate that those figures can increase to 50% or more. And indeed, in PATHFINDER 2, this number was 60%. This represents a substantial improvement that expands detection of clinically meaningful cancers that otherwise lack recommended screening. Across these 2 studies, approximately 40% to 50% of the Galleri detected cancers were found at Stages 1 and 2 and approximately 70% were found at Stages 1 through 3. Remarkably, in the NHS-Galleri study, Galleri detected 366 Stage I and II cancers, many more than the 290 cancers detected at any stage by the entirety of the U.K.'s standard of care screening program in the control arm. This is truly remarkable. The promise of multi-cancer early detection is not just in finding cancer, but in finding it early enough to open the door to curative treatment options for as many people as possible. What is clear across these groundbreaking trials is that the Galleri test detects a large number of asymptomatic cancers in stages 1 through 3, the majority of which have the opportunity for curative intent treatments. Together, these findings underscore the consistency and actionability of the Galleri test results and demonstrate that adding Galleri to standard of care screening has the potential to improve the effectiveness and efficiency of our current national screening program. This is critical for providers, regulators and payers as they evaluate the clinical and economic value of Galleri alongside standard of care screening. These data support the potential of MCED screening at population scale to identify cancers at earlier stages when treatments are more effective and are potentially curative. Turning now to our regulatory process. We submitted our premarket approval application to the FDA in early '26, and we remain in an ongoing iterative review process. We are very confident in the data package that's been submitted. Galleri's performance has been validated and replicated in multiple rigorous intended use population level studies. We have consistently shown that Galleri can detect asymptomatic cancers well over and above the standard of care, and the evidence clearly demonstrates that Galleri can be useful and safe when implemented at scale. Our PMA for Galleri is focused on test performance and safety results from the first approximately 25,000 participants in the PATHFINDER 2 study with 1 year of follow-up and the prevalent screening round for the first year of the NHS-Galleri trial. The submission also includes a bridging analysis to compare performance of the version of Galleri used in these clinical studies to the updated version that has been submitted to the FDA for premarket approval. As Galleri is a first-of-its-kind technology and multi-cancer early detection represents a potential paradigm shift in cancer screening, we do expect the FDA to convene an advisory committee for Galleri in the fall. The FDA will announce specific timing of an advisory committee. Turning now to the evolving market environment. As additional MCED tests have launched, a few things are very critical to mention. Other MCED products have been introduced based only on observational case control data and have yet to evaluate the benefits and harms in an actual screening population. First, that means it is unknown how the purported benefits of these tests shown in case control data will translate, if at all, into performance when deployed into an asymptomatic screening population. And without interventional studies, it's not clear whether the diagnostic pathways and procedures have been developed to support physicians and patients after a positive test. Second, MCED tests with high false positive rates may expose patients to significant risks of radiation exposure and invasive diagnostic tests, which carry potential for complications and increased morbidity. Until these tests have been robustly studied and validated in the intended use screening population, they represent an unknown benefit risk profile and should be considered experimental screening tests at this stage. When we launched Galleri, we deliberately chose to do so only after reporting results from a prospective interventional study under an FDA-approved investigational device exemption in the screening population. We believe that patients deserve and the field demands this level of robust evidence because the true litmus test performance, both benefits and harms is demonstration in interventional clinical studies in the actual intended use population. Now why do I say this? This is because case-control data will not always replicate in interventional studies. For example, after a very strong performance for the CancerSEEK assay was observed in a case-controlled study published in a top-tier journal of science, the DETECT-A study failed to replicate performance and safety in an interventional study. And as you know, this test is currently not available or on the market. Beyond study rigor, Galleri test characteristics stand apart in the field. Based on data from observational studies that are case controlled, experimental MCED tests are operating at a 3x to 5x higher false positive rate. They detect a smaller number of cancer types and some have no ability to predict a cancer signal origin, which we believe is necessary for safety and performance of any MCED test. In a field where hope and hype can easily collide, GRAIL is defined by rigorous science and validated by the most extensive evidence base. We believe we chose the right biological signature of cancer after unbiased comparisons. We have built the most advanced proprietary technology to interpret that signal, and we have proved its performance in the real world on an unprecedented scale. I'll now hand off to Aaron for a review of our second quarter financials. Aaron Freidin: Thanks, Josh, and good afternoon, everyone. Second quarter results were strong with revenue of $44.7 million, up $9.1 million or 26% as compared to the second quarter of 2025. Total revenue for the second quarter consisted of $42.6 million of screening revenue and $2 million of development services revenue. Screening revenue was up 24% as compared with the second quarter of 2025, with test volumes of more than 61,000, an increase of 35% over the second quarter of 2025. Net loss for the quarter was $110.2 million, a decrease of 3% as compared to the second quarter of 2025. Non-GAAP adjusted gross profit for the second quarter was $21.6 million, an increase of $5.4 million or 34% as compared with the second quarter of 2025. Primary drivers of the increased gross margin were improved fixed cost leverage from higher volumes and a decrease in sample reprocessing costs, partially offset by a decrease in ASP. Adjusted EBITDA for the second quarter was negative $90.3 million, an increase in adjusted EBITDA loss of $11.9 million or 15% as compared to the second quarter of 2025. We ended the second quarter with a cash position of $861.6 million, which includes $110 million strategic investment by Samsung, which closed in June. Our cash balance today provides us with financial flexibility as we advance key priorities, including securing regulatory approval and reimbursement for Galleri in the United States. Back to you, Josh. Joshua Ofman: Thank you, Aaron. We're really pleased with the continued growth for Galleri and the progress we're making towards FDA approval and broad-based access, and we anticipate continued progress over the next year. With ASCO behind us, our expanded field teams are now fully equipped to educate clinicians about our groundbreaking trial results and continue market development. And initial feedback from the field has been really positive. We look forward to potential FDA approval of Galleri. Expanding distributor partnerships internationally, progressing R&D on Gallery improvements and cost of goods reduction and publication of the NHS-Galleri and PATHFINDER 2 studies as well as additional analyses from our extensive clinical program. Operator, we can now go to Q&A. Operator: [Operator Instructions] Our first question will come from Subbu Nambi with Guggenheim. Subhalaxmi Nambi: As you anticipate an FDA AdCom in the fall, where do you think the FDA will focus on? Like what type of questions? And how are you preparing for those questions? Joshua Ofman: So we are obviously getting ready and preparing internally. We don't know the nature of any of that information at this time, but we should -- obviously, we'll be informed about that as the time approaches. We're waiting to hear something from the FDA as it relates to timing. Subhalaxmi Nambi: Okay. That's helpful. And then given all the leadership changes at the FDA and the delays we have seen recently when it comes to finding the right panelists for AdComs, is there a risk this meeting pushes into next year at all? I know it's an unfair question. Joshua Ofman: Well, it's fine. We don't know the answer to that question. We know that the division that we're working with has been fairly stable at the FDA, which has been very, very positive and productive. And we continue our iterative review with them. But I couldn't really comment on their ability to find experts. Subhalaxmi Nambi: Okay. Can I squeeze one more? Would you expect CMS to wait for an FDA approval before better defining the NCD criteria for an MCED test? Joshua Ofman: Again, it's a good question. I'd be speculating if I try to answer it. We do know that CMS' coverage authority is only for FDA-approved products. So our assumption has been that they would only undertake a national coverage analysis upon an FDA approval. Whether they're going to set specific coverage criteria is unknown. Operator: Our next question will come from Kyle Mikson with Canaccord Genuity. Kyle Mikson: Yes, following up on Subbu's questions about FDA. So maybe, Josh, like it wasn't clear to me what the specific communication with the FDA was for you to now anticipate the meeting AdCom in the fall. So if you could talk about that, that would be helpful. And then additionally, in the past, you've talked about like an early '27 sort of approval time line. Let's say this is like mid-fall or something. How would that affect your new time line for FDA approval? Joshua Ofman: No. We have long stated publicly that we would anticipate that a groundbreaking technology like an MCED test like Galleri that is really changing the potential cancer screening paradigm would get an advisory panel. And we continue to believe that. There's no specific information that's been made public yet from the FDA about that, but we certainly are anticipating that an AdCom would occur. The timing of it has not been made public yet. So that's still to come. And our current anticipation for potential approval as it relates to timing remains unchanged. We would expect it to occur in the first part of 2027. Kyle Mikson: Perfect. And then on competition, you called that out, that's interesting. It doesn't seem like there's been a volume impact, but how is that impacting your pricing? It looks like ASP in the quarter was $700 or something around there. And then kind of on that note, I think USPSTF is meeting later this month. Could they possibly talk about MCED at that meeting? Or how do you think that progresses given it's more noise in the marketplace than some of these other entrants recently? Joshua Ofman: Yes, it's a fair question. Let me take your second question, and then I'll have Andy address your first. As it relates to U.S. PSTF, I think there's just a lot that's unknown right now about the USPSTF. It's unknown what its composition is going to be, what its focus will be. And I think without -- before there's an FDA-approved product on the market, it's, in my mind, less likely that they're going to take MCEDs up irrespective of the amount of noise that's in the market or not. But there's just a lot of unknown about the USPSTF and its mandate at this time. Your first question, which was about the impact of competition on our pricing, I'm going to let Andy discuss that. Andrew Partridge: Yes. I think the -- first of all, the ASP decrease in second quarter '26 was the result of expansion of digital health volume and also lower employer pricing, which was planned. That reduced employer pricing has come along with the benefit of strengthened partnerships with those employers such as specific marketing commitments and blood draw events. In terms of competition, there's definitely been some active competition that we've seen that has been stepped up, as I'm sure you've also seen. It has been causing some customer confusion in the market, given, as Josh outlined earlier, these what we would call experimental MCEDs do not have data in the screening population. So many of their performance characteristics are unknown to those prescribing physicians. They also have higher false positive rates. So what we're seeing with physicians that have experimented with some of these MCEDs is quite a bit of confusion due to these higher false positive rates and unclear performance characteristics. That's something that our sales team are following up with those customers to reinforce Galleri's extensive clinical program that we've conducted and the clinical results that we've presented and published. And as Josh said, the initial reactions from these conversations where we followed up with our customers with the data that was presented at ASCO for both PATHFINDER 2 and NHS-Galleri has been very promising and very favorably received. Joshua Ofman: That's great, Andy. I would just add one other thing. The noise that's been interjected into the market, we expect that our anticipation is that we will have an FDA approval, and that will create a bifurcation in the market and clear up a lot of that noise. We expect the market really to evolve one side with Galleri as a well-validated and potentially FDA-approved MCED and then the other side of the market with the other MCEDs that are still, quite frankly, in development with unknown risk-benefit profiles in the intended use population. And so they'd be considered very experimental. So we see that bifurcation coming, and we look forward to executing upon it. Operator: Our next question will come from Bradley Bowers with Mizuho. Bradley Bowers: Maybe just wanted to click on the sales force expansion, obviously, a pull forward of some of the costs. Just wanted to hear about why the timing is right. Seemingly the first part of 2027 timeline seems coincident with expected productivity ramp. But also just wanted to hear about if you knew about the AdCom scenario from the FDA kind of when you allocated the size and if this is kind of the max sales force used up? Joshua Ofman: Yes, we pulled forward the sales force expansion really on the back of the NHS-Galleri and PATHFINDER 2 data that we announced earlier in the year. given how excited we were with both sets of that data. That sales force expansion is essentially complete now. Those sales members are now in the field. We expect to see the true benefit of that additional sales force horsepower as we go through the rest of the year. And the other reason that we did this is to have those new salespeople in territory, all trained so that they can truly meet the moment of FDA approval, as Josh outlined, as this is going to be a landmark event for GRAIL, really establishing Galleri as the gold standard MCED. Bradley Bowers: Got it. And just real quick, would you give a number just because of competitors we do know a lot of them. And then just actually totally switching gears. On the panel, do you think this would make it may be easier or harder for the incremental MCED test, asking just because the government initiative right now seems to be just trying to ease the pathway towards getting MCED tests, adding more to the market. But obviously, the panel would be kind of differentiated. So I wanted to hear if you think it would be kind of a competitive advantage, kind of an extra barrier to entry or if it might have the adverse effect of making it easier for other MCEDs down the line? Joshua Ofman: Just to clarify, when you say a panel, do you mean an advisory committee panel? Bradley Bowers: Sorry, I apologize. Yes, this fall, the meeting this fall. Joshua Ofman: Yes. No, an AdCom, look, the reason we expect an AdCom is because typically, when the FDA reviews a kind of groundbreaking pioneering type of technology, particularly one that could have this kind of impact on public health that is really paradigm changing. They typically hold an AdCom because they want to get advice from other experts. The AdCom will be completely about Galleri. It will not be about the field of MCEDs. It won't be about other MCEDs. It will be just about our data package that we submitted to the FDA. So we don't really view it as a competitive advantage or disadvantage. We view it as part of the FDA approval process for a groundbreaking technology like Galleri. I mean to your further question, I don't think that, that has necessarily any bearing on whether there will be AdComs for future MCEDs. And I don't see any MCEDs right now even on the horizon and doing registrational trials or anything like that. So it's really hard to say. Andrew Partridge: Yes. And I think just building on Josh's point, what the AdCom and the FDA approval is going to do is establish that approval bar for future MCEDs. And that's why we're excited for this panel and for the anticipated FDA approval that it is going to set that bar for future MCEDs coming forward. Operator: Our next question will come from Dan Brennan from TD Cowen. Daniel Brennan: Maybe just one more on the panel since it's obviously the topic to Josh -- so Josh, you sounded pretty definitive that there will be a panel. The FDA will alert us when -- kind of when the time is right. Can you just share any color like -- so does that mean like an outright decision popping up one day is off the table? Like just what's the level of the discussions that you have with FDA under these types of processes? And just anything you could share on that front would be helpful. Joshua Ofman: Yes. There's not a lot we can share until the FDA decides to make a public pronouncement one way or the other. But from the very outset, we have been anticipating an AdCom. We've stated that numerous times. we don't see any reason why that wouldn't be the case. And so really, it's just our own internal preparation at this point until the FDA decides to make a public pronouncement. But we're prepared for one. We continue to prepare. We feel very confident about the evidence package that we've submitted to the FDA. We've been in a very productive, iterative review process and going through all the relevant steps of inspections and other things that you would expect going into a PMA. So things are progressing well, and we look forward to hearing more from the FDA. Daniel Brennan: Great. Is there anything you can share about the back and forth like in terms of -- obviously, you can't get into specifics, but I'm sure there's a certain cadence of questions and responses, but I'm not sure how you might categorize those if there's anything you could share on that front? Joshua Ofman: Not really. I mean it's pretty typical. There have been a series of questions. We've responded. There's been a series of inspections. We've performed through those. And so it's just a very standard process, not much I can really share. Daniel Brennan: Okay. How about the marketing since ASCO? I know that you guys were kind of held back a bit from being out in the field since the NHS-Galleri headline was out, but you wanted to wait until you presented the full data set at ASCO. Now that, that was out, can you just share any color about how -- like what the plan has been in the last 6 weeks or so or 8 weeks, excuse me, -- what have you guys done? How many customers have you hit? What's been the response? Anything on that front to kind of provide color on? Joshua Ofman: Yes. We trained all of the sales force the week after the ASCO meeting. So we plan to do that. We also trained all of our new sales force that we brought on board in terms of the sales force expansion. And our sales teams have been out there talking to customers, both health care providers and to employer customers. The reaction has been very favorable from customers as we've explained to them, both the PATHFINDER 2 data and the NHS-Galleri data, really establishing that Galleri is the only MCED proven to reduce Stage 4 diagnoses and physicians have reacted very favorably to that. And really, this has been the promise of Galleri all along to increase early-stage detection and reduce late-stage detection, enabling more patients to receive curative intent therapy. So everything very promising up until this point. Aaron Freidin: Yes, I was in the field recently as well, speaking with clinicians and practicing providers. And when they hear the results of the study, like we found Galleri found more early Stage I and II cancers in the NHS trial than the entire number of cancers found by the U.K.'s national screening program is pretty remarkable. And I think it has quite an impact -- we also found that there was a dramatic increase in the Stage 1 and 2 screen detected cancers in the Galleri arm compared to the control arm in NHS-Galleri. And then, of course, there was a 6.5-fold increase in the overall cancer detection rate in PATHFINDER 2 when added to standard of care. And so when you talk to doctors about those kinds of numbers, you get a very positive reaction. And Andy's point is I want to underscore it. The whole purpose of screening for cancer is to give individuals an opportunity to find cancer in stages that have curative intent opportunities. And in PATHFINDER 2, for example, the vast majority of Galleri detected cancers received curative intent treatment. Daniel Brennan: Great. And maybe just I'll sneak 2 more in. Publication, just latest thoughts there, timing, when we might expect the data to be in a leading journal? Harpal Kumar: Yes, Harp here. So we have submitted publications both on PARFNDER-2 and NHS-Galleri. Those have been in active review at top-tier journals, and those review processes are going well, and they're going quickly. And so we are hopeful of publication in the near future. Daniel Brennan: Great. And then maybe -- so assuming FDA approval comes at some point this fall or early next year, obviously, Medicare will have to follow the decision there. But in the interim, what type of impact will FDA approval do you think have upon either did some payers adopt then? Will maybe self-insured plans look to do anything, volumes? Just what's the meaning of FDA approval, do you think on the business, say, like in that 12-month period between that decision and when the Medicare decision comes? Andrew Partridge: Yes. So FDA approval is really the gate that a lot of payers have been waiting for to really dig into Galleri and serious conversations. So we're looking forward to that. Also, many employers have told us that they're waiting for FDA approval as well. So that's going to put a wind at our backs with both employers and with payers going forward. And then, of course, health care providers. Josh and I have talked about the confusion that's being caused by experimental MCEDs promoting their unproven tests. FDA approval is going to give providers the confidence that Galleri is the gold standard MCED. So we feel that's also going to give our sales teams a lot of confidence going forward in terms of their sales efforts to provider clinics. Operator: Our next question will come from David Westenberg from Piper Sandler. Karan Patel: It's Karan Patel on for David Westenberg. And I'll maybe shift gears here. If you could speak to the Illumina royalty resuming sometime in Q4, how can we think about margins for Q4 and then specifically for full year '27? Joshua Ofman: Yes, Karan. So that royalty will kick in towards the end of Q4. So I wouldn't -- it's not going to have an impact on Q4 in any meaningful way. And we've been disclosing what that royalty would be every quarter. So far in our -- in the financials, so you can see what that would have been if we had been paying it. We disclosed in the financials, it's 7% to 9%, 7% royalty, I believe. And you can do your modeling to see what the impact would be based off of the volumes that you're expecting in the ASPs. So minimal for 4Q. Operator: Our next question will come from Kallum Titchmarsh from Morgan Stanley. Kallum Titchmarsh: Sorry again to move back to the AdCom. I was just reading through the transcript from the Q4 call back in February. And the message did seem to be that you were prepping for an AdCom, but one likely wasn't necessary. So I'm still just trying to unpackage what perhaps has changed maybe from the questions that you've had from the FDA to the tone that you've given today. And I realize you can't perhaps go into too many of the specifics, but just some guidance would be helpful. Aaron Freidin: There's nothing that's changed in our minds or in our point of view about the FDA AdCom. I'm not sure what you're reading into prior comments. We've been very consistent saying that we are expecting that there will be an AdCom, and we still expect that, and we're fully prepared for that. In fact, we look forward to the opportunity to really discuss this data package, which is unprecedented in performance and scale with the AdCom. Kallum Titchmarsh: Okay. Fair enough. And then some pretty sizable financing completed with Samsung in the quarter. Can you maybe just speak to the level of engagement there and how we should be thinking about the regulatory and commercial time lines in South Korea, Japan and Singapore? Aaron Freidin: Yes, it's Aaron again. Yes, so we closed that in for the end of the quarter, and we're just kicking off those discussions now around distribution in the near term and then any sort of longer-term strategic engagement. As you recall, we were under CFIUS review during that period, and we weren't engaging with each other as such. So we'll be able to provide more color on that as we move through the year. Operator: Our last question will come from Robert Bamberger with Baird. Unknown Analyst: This is [ Josh ] on for Rob. I guess, first, another solid quarter for Galleri here. What was the primary growth driver in the quarter? Was this more on new physician adds or improving order rates among existing physicians? Joshua Ofman: Self-pay remains the majority of Galleri's volume, accounting for about 70% of sales. We see that most of the volumes coming from brick-and-mortar physicians, and we added, again, about 1,000 new ordering providers in Q2. Depth of prescribing continues to increase over time. Electronic order integrations with Quest and Athena are also both bringing on new prescribers themselves and helping increase the depth of prescribing as well, given we don't just want to have the best performing tests and the gold standard MCED. We also want to have the easiest test for prescribers to prescribe to their patients. We also continue to see very strong growth in our digital health business from both new and existing digital health partners. We've seen continued expansion in employers that are offering the test and also expansion in some new digital health partners. And also, as we announced expansion in our payer partnerships with Priority Health now joining a number of other ASO payers who have decided to offer the Galleri test to their employer base of customers. Unknown Analyst: Great. And I was just wondering, too, with the NHS, how have discussions here gone around expanded Galleri studies or future collaborations? Do you have any concerns around the ongoing NHS reform? How is that impacting Galleri and diagnostic aid for cancer conversations? Joshua Ofman: Yes. So look, the there's no getting around the fact that the fundamental changes in the sort of organizational structure and governance for NHS services in the U.K. is causing some hiatus in decision-making and what those future structures will look like, and there's still an enormous amount of uncertainty around that and quite a lot of organizational upheaval that's flowing from that. What I will say is that as we have talked to the leading clinicians in the NHS and indeed clinicians more generally in the U.K. the overwhelming reaction is one of positivity about the results. Really, as Andy has described for the U.S., we're seeing a great deal of enthusiasm around the Stage 4 reduction and some of the other metrics that we've talked about, but particularly the Stage 4 reduction and the opportunity that promises to really transform cancer outcomes. So look, as we get through this, as I say, this organizational upheaval with the NHS, I would anticipate those conversations will translate into defining hopefully a meaningful way forward. Operator: Thank you. There are no further questions at this time. Ladies and gentlemen, this concludes the call. You may now disconnect. 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This article first appeared on GuruFocus. Total Revenue: $44.7 million, up 26% year over year. Screening Revenue: $42.6 million, up 24% year over year. Development Services Revenue: $2 million. Test Volume: Over 61,000 Galleri tests sold, a 35% increase year over year. First Half 2026 Screening Revenue: Over $80 million, up 30% year over year. First Half 2026 Test Volume: Over 117,000 tests, up 42% year over year. Net Loss: $110.2 million, a 3% decrease compared to the second quarter of 2025. Non-GAAP Adjusted Gross Profit: $21.6 million, an increase of 34% year over year. Non-GAAP Adjusted EBITDA: Negative $90.3 million, a 15% increase in loss year over year. Cash Position: $861.6 million at the end of the quarter, including the $110 million Samsung investment. Warning! GuruFocus has detected 2 Warning Sign with GRAL. Is GRAL fairly valued? Test your thesis with our free DCF calculator. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. GRAIL Inc (NASDAQ:GRAL) reported strong Q2 2026 results with total revenue of $44.7 million, up 26% year-over-year, driven by a 35% increase in Galleri test volumes to over 61,000 tests. The company's clinical evidence base is unmatched, with data from the 140,000-participant NHS Galleri trial and 35,000-participant Pathfinder 2 study demonstrating a false positive rate of less than 0.5% and a 4 to 6.5 times increase in cancer detection when added to standard of care. GRAIL Inc (NASDAQ:GRAL) completed a $110 million strategic investment from Samsung, which will support international expansion into Asian markets including South Korea, Japan, and Singapore. The company's expanded field sales and medical teams are now fully onboarded and trained, with initial feedback from physicians since the ASCO conference being very positive. GRAIL Inc (NASDAQ:GRAL) ended Q2 2026 with a strong cash position of $861.6 million, providing financial flexibility to advance key priorities including FDA approval and reimbursement. The company announced a new collaboration with Priority Health to expand employer group coverage for the Galleri test, building on existing payer partnerships. The primary endpoint of the NHS Galleri triala combined reduction of stage III and IV cancerswas not met, which could raise questions about the test's ultimate clinical utility. GRAIL Inc (NASDAQ:GRAL) expects the FDA to convene an advisory committee in the fall, adding uncertainty to the approval timeline, which is currently anticipated for early 2027. The company faces increasing competition from other multi-cancer early detection (MCED) tests that are launching based on case-control data, causing confusion in the market and potentially impacting pricing. Average selling price (ASP) decreased in Q2 2026 due to planned lower employer pricing and expansion of digital health volume, which could pressure future revenue growth. Adjusted EBITDA loss widened by 15% year-over-year to negative $90.3 million, reflecting increased investment in sales force expansion and other growth initiatives. The Illumina royalty obligation will resume in Q4 2026, which will negatively impact gross margins and profitability going forward. Q: As you anticipate an FDA outcome in the fall, where do you think the FDA will focus on, and how are you preparing for those questions? A: Josh Offman, CEO, stated that GRAIL is preparing internally but does not yet know the specific nature of the FDA's questions. He noted that the division they are working with at the FDA has been stable and productive, and they are waiting for the FDA to announce the timing of the advisory committee meeting, which they expect to occur in the fall. Q: Can you share any color on the FDA communication that led you to anticipate an advisory committee meeting in the fall, and how would a mid-fall meeting affect your timeline for FDA approval? A: Josh Offman, CEO, clarified that GRAIL has long anticipated an advisory committee for a groundbreaking technology like Galleri, but the FDA has not yet made a public announcement on timing. He reaffirmed that the company's expectation for potential approval remains unchanged, with approval anticipated in the first part of 2027. Q: How is competition impacting your pricing, and could the USPSTF discuss MCED at its upcoming meeting? A: Andy Partridge, Chief Growth Officer, explained that the ASP decrease in Q2 2026 was due to planned expansion of digital health volume and lower employer pricing, which came with strengthened partnerships. He noted that competition has caused customer confusion due to higher false positive rates and unclear performance characteristics of other MCED tests, but GRAIL's sales team is reinforcing Galleri's extensive clinical data. Josh Offman, CEO, added that it is unlikely the USPSTF will take up MCED before an FDA-approved product is on the market. Q: Why was the timing right for the Salesforce expansion, and is this the max sales force you expect? A: Andy Partridge, Chief Growth Officer, stated that the Salesforce expansion was pulled forward based on the positive NHS Galleri and Pathfinder 2 data announced earlier in the year. The expansion is now complete, and the new salespeople are in the field, trained and ready to capitalize on the anticipated FDA approval, which will be a landmark event establishing Galleri as the gold standard MCED. Q: Do you think the advisory committee will make it easier or harder for incremental MCED tests to gain approval? A: Josh Offman, CEO, explained that the advisory committee will focus solely on GRAIL's data package for Galleri, not the broader MCED field. He noted that the adcom is part of the FDA approval process for a groundbreaking technology and does not view it as a competitive advantage or disadvantage. Andy Partridge, Chief Growth Officer, added that the adcom and FDA approval will establish the approval bar for future MCED tests. Q: Can you share any details on the back-and-forth with the FDA during the review process? A: Josh Offman, CEO, stated that the process has been typical, involving a series of questions and responses, as well as inspections. He noted that the review process is progressing well and that GRAIL is confident in the evidence package submitted, but he could not share specific details of the interactions. Q: What has been the marketing plan since ASCO, and how have customers responded? A: Andy Partridge, Chief Growth Officer, said that GRAIL trained its entire sales force the week after ASCO and has been actively engaging with healthcare providers and employer customers. The reaction has been very favorable, with physicians responding positively to the data showing Galleri is the only MCED proven to reduce stage 4 diagnoses. Josh Offman, CEO, added that the dramatic increase in early-stage cancer detection and the 6.5-fold increase in overall cancer detection rate in Pathfinder 2 have had a significant impact on clinicians. Q: When might the Pathfinder 2 and NHS Galleri data be published in a leading journal? A: Sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs, stated that both publications have been submitted to top-tier journals and are in active review. The review processes are going well and quickly, and GRAIL is hopeful of publication in the near future. Q: What impact will FDA approval have on the business in the 12-month period between the decision and a potential Medicare decision? A: Andy Partridge, Chief Growth Officer, explained that FDA approval is the gate that many payers and employers have been waiting for to engage in serious conversations about Galleri. The approval will give providers confidence that Galleri is the gold standard MCED, and it will also boost the confidence of GRAIL's sales teams in their efforts to provider clinics. Q: How should we think about margins for Q4 and full year 2027 given the Illumina royalty resuming in Q4? A: Aaron Freidin, CFO, stated that the royalty will kick in toward the end of Q4 and will not have a meaningful impact on Q4. He noted that GRAIL has been disclosing the royalty amount (7% of revenue) in its financials, allowing analysts to model the impact based on expected volumes and ASPs. Q: What was the primary growth driver in the quarter, and how are discussions with the NHS progressing? A: Andy Partridge, Chief Growth Officer, noted that self-pay remains the majority of Galleri volume (about 70% of sales), with most volume coming from brick-and-mortar physicians. GRAIL added about 1,000 new ordering providers in Q2, and electronic health record integrations with Quest and Athena are helping increase prescribing depth. Sir Harpal Kumar, Chief Scientific Officer, added that while NHS organizational changes are causing some hiatus in decision-making, leading clinicians in the UK have reacted positively to the results, particularly the stage 4 reduction, and GRAIL anticipates translating those conversations into a meaningful way forward. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the 35% year-over-year volume growth to increased physician adoption and the expansion of digital health and employer partnerships. The company emphasized that Galleri is the only MCED test validated by large-scale interventional studies, contrasting it with competitors who rely on observational case-control data. Performance in the NHS-Galleri and PATHFINDER 2 trials demonstrated a 4x to 6.5x increase in cancer detection rates when added to standard of care, with a false positive rate of less than 0.5%. Strategic positioning is focused on a 'bifurcation' of the market, where FDA approval will distinguish Galleri as a validated clinical tool versus 'experimental' tests with unknown risk-benefit profiles. The $110 million Samsung investment is framed as a long-term strategic anchor to facilitate commercial entry into South Korea, Japan, and Singapore. Operational focus has shifted to field sales force expansion, which was substantially completed in Q2 to prepare for the anticipated regulatory and commercial inflection points. Management noted that while the NHS-Galleri trial did not meet its primary endpoint of combined Stage III and IV reduction, the significant reduction in Stage IV diagnoses alone remains a powerful clinical utility signal. GRAIL maintains its expectation for potential FDA approval in the first half of 2027, following an anticipated advisory committee meeting in the fall of 2026. The company assumes that CMS national coverage analysis will only commence following formal FDA approval, as Medicare coverage authority is tied to approved products. Future margin profiles will be impacted by a 7% to 9% royalty to Illumina starting in late Q4 2026, though the immediate impact on 2026 results is expected to be minimal. Management anticipates that FDA approval will serve as a critical catalyst for private payers and self-insured employers who have been waiting for regulatory clearance to finalize coverage. Strategic collaboration with Samsung C&T is expected to move into active distribution planning for Asian markets following the recent closing of the financing and completion of regulatory reviews. The $110 million strategic investment from Samsung closed in June, bringing the total cash position to $861.6 million to fund regulatory and reimbursement priorities. Average Selling Price (ASP) experienced a planned decrease due to the expansion of digital health volumes and lower pricing offered to employer groups in exchange for marketing commitments. Management flagged ongoing organizational upheaval and governance changes within the U.K. NHS as a source of uncertainty for future decision-making timelines regarding national rollouts. The company highlighted the risk of 'biological noise' and higher false positive rates in competing methylation-plus-multi-omic tests, which they claim adds cost without improving performance. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expects the AdCom to focus exclusively on Galleri's specific data package rather than the broader MCED field. While the exact date is pending FDA announcement, GRAIL is preparing for a fall meeting and does not currently see a risk to the early 2027 approval timeline. Management acknowledged 'active competition' has caused some customer confusion regarding performance characteristics and false positive rates. They believe FDA approval will clear this 'noise' by establishing a high regulatory bar that current experimental competitors have not yet met. The sales force expansion was pulled forward to capitalize on the positive ASCO data presentations and ensure the team is fully trained before the 2027 approval. Initial feedback from the expanded team's engagements with physicians and employers has been 'very promising' following the release of the NHS-Galleri and PATHFINDER 2 results. Chief Scientific Officer Harpal Kumar confirmed that publications for both PATHFINDER 2 and NHS-Galleri are currently under active, fast-track review at top-tier journals. Management expects these publications to be released in the 'near future,' providing further academic validation for the test's performance.

Interested in GRAIL, Inc.? Here are five stocks we like better. Revenue and Galleri volumes grew strongly: Second-quarter revenue increased 26% year over year to $44.7 million, while Galleri test volume rose 35% to more than 61,000. Adjusted gross profit climbed 34% to $21.6 million, although adjusted EBITDA losses widened to $90.3 million. FDA review remains the key catalyst: GRAIL said its Galleri premarket approval application remains under iterative FDA review, with an advisory committee potentially meeting this fall and a decision still expected in early 2027. Approval could accelerate payer and employer discussions and differentiate Galleri from less clinically validated competitors. Expansion is advancing with substantial liquidity: GRAIL ended the quarter with $861.6 million in cash, including a $110 million Samsung strategic investment that supports U.S. regulatory efforts and potential distribution in South Korea and other Asian markets. The company also expanded its sales force, added about 1,000 ordering providers and launched a Priority Health employer-coverage collaboration. Small-Cap Standouts: These 3 Stocks Rose Over 300% in 2025 GRAIL (NASDAQ:GRAL) reported second-quarter revenue growth driven by higher Galleri test volumes, while outlining continued efforts to secure FDA approval, expand its commercial organization and build international distribution partnerships. Revenue totaled $44.7 million in the second quarter, up 26% from the prior-year period, Chief Financial Officer Aaron Freidin said. Screening revenue contributed $42.6 million, an increase of 24%, while development services revenue was $2 million. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Why GRAIL Stock Could Be Biotech’s Next Big Breakout The company sold more than 61,000 Galleri tests during the quarter, representing a 35% year-over-year increase in volume. For the first half of 2026, Galleri screening revenue exceeded $80 million, up 30% from a year earlier, while test volume surpassed 117,000 tests, a 42% increase. GRAIL reported a net loss of $110.2 million for the second quarter, a 3% decrease from the second quarter of 2025. Adjusted gross profit rose 34% to $21.6 million, which Freidin attributed primarily to greater fixed-cost leverage from higher volume and lower sample reprocessing costs. Those gains were partly offset by a lower average selling price. → 3 Drone Stocks That Should Soar After the Summer Slump 3 Medical Technology Stocks Outperforming in 2025 Adjusted EBITDA was negative $90.3 million, compared with a loss of $78.4 million a year earlier. The company ended the quarter with $861.6 million in cash, including a $110 million strategic investment from Samsung that closed in June. Freidin said the Samsung investment provides financial flexibility as GRAIL pursues regulatory approval and reimbursement for Galleri in the U.S. The company has begun work with Samsung C&T Corporation on a collaboration to commercialize Galleri in South Korea, with potential expansion into Japan, Singapore and other Asian markets. Freidin said discussions on distribution and longer-term strategic engagement were just beginning following the completion of a CFIUS review. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Chief Executive Officer Josh Ofman said GRAIL submitted its premarket approval application for Galleri to the FDA in early 2026 and remains in an “ongoing iterative review process.” The company expects the FDA to convene an advisory committee in the fall, although the agency has not announced timing. Ofman said GRAIL’s expected timing for a potential approval remains unchanged, with the company anticipating a decision in the first part of 2027. He said the company has responded to a series of FDA questions and completed inspections as part of what he characterized as a standard PMA review process. The PMA submission is based on performance and safety findings from approximately 25,000 PATHFINDER 2 participants with one year of follow-up, along with data from the first-year prevalent screening round of the NHS-Galleri trial. It also includes a bridging analysis comparing the Galleri version used in clinical studies with the version submitted for FDA approval. Ofman said the company believes an FDA approval could prompt more substantive discussions with payers and employers. Chief Growth Officer Andy Partridge said payers and employers have indicated that they are awaiting FDA approval before engaging more seriously on Galleri coverage and adoption. GRAIL presented data from its PATHFINDER 2 and NHS-Galleri studies at the American Society of Clinical Oncology annual meeting in May. Ofman said that, across both studies, adding Galleri to standard-of-care screening increased cancer detection rates by four to 6.5 times. He said the test showed a false-positive rate below 0.5% and positive predictive values ranging from 50% to 60%. The company acknowledged that the NHS-Galleri trial did not meet its primary endpoint of reducing the combined incidence of stage III and stage IV cancers. However, Ofman said GRAIL believes other study findings demonstrated performance, safety and clinical utility. He said approximately 40% to 50% of cancers detected by Galleri across the two studies were stage I or II, while roughly 70% were stage I through III. GRAIL has submitted publications on both studies to top-tier journals, according to Chief Scientific Officer Harpal Kumar, who said the papers remain under active review and that the company is hopeful for publication in the near future. The company substantially completed a planned expansion of its field sales and medical teams by the end of the second quarter. Partridge said the added personnel were trained after ASCO and are now engaging physicians and employer customers with the clinical data. He said management expects to see the fuller benefit of the expanded sales organization over the remainder of the year. Partridge said self-pay purchases represented about 70% of Galleri sales, with most volume coming from brick-and-mortar physicians. GRAIL added roughly 1,000 ordering providers during the quarter. Electronic ordering integrations with Quest Diagnostics and athenahealth are also supporting new prescriber adoption and deeper utilization, he said. Partridge said the second-quarter decline in average selling price reflected expansion in digital-health volume and planned lower pricing for employers. In exchange for lower employer pricing, GRAIL has sought commitments such as marketing support and blood-draw events, he said. The company also announced a collaboration with Priority Health that enables employer groups to add Galleri to existing screening coverage. Priority Health has more than 1.4 million members in Michigan and nearby states and had launched Galleri coverage in certain plans during 2025, according to GRAIL. Management addressed growing competition in the multi-cancer early detection market, arguing that competing tests have generally been supported by observational or case-control data rather than interventional studies in asymptomatic screening populations. Ofman said GRAIL expects a potential FDA approval to distinguish Galleri from tests that have not yet established their risk-benefit profile in intended-use populations. GRAIL also said an Illumina royalty is expected to resume toward the end of the fourth quarter. Freidin said it would not have a meaningful effect on fourth-quarter results and referred investors to the company’s financial disclosures for details on the royalty. GRAIL, Inc (NASDAQ: GRAL) is a biotechnology company dedicated to the early detection of cancer through a multi-cancer blood test. Leveraging advances in next-generation sequencing, cell-free DNA (cfDNA) analysis and machine learning, GRAIL has developed the Galleri™ test, which aims to identify more than 50 types of cancer at their earliest stages. The company's platform analyzes methylation patterns in circulating tumor DNA to pinpoint tumor presence and tissue of origin, enabling physicians to pursue timely diagnostic follow-up. Founded in 2016 as a spin-out from Illumina, GRAIL established its headquarters in Menlo Park, California, with additional research and operations centers in the United Kingdom. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "GRAIL Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Q2 Galleri® Test Volume Increased 35% to More Than 61,000 Year-Over-Year, and Galleri Revenue Grew 24% to $42.6 Million Galleri Test Volume and Revenue are up 42% and 30% Year-Over-Year, Respectively, for the First Half of the Year NHS-Galleri and PATHFINDER 2 Study Results Presented at 2026 ASCO Annual Meeting Demonstrated Consistent Strong Performance and Clinical Utility for Galleri Completed $110 Million Equity Financing With Samsung MENLO PARK, Calif., Aug. 5, 2026 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the second quarter of 2026. Total revenue in the second quarter grew 26% year-over-year to $44.7 million, and Galleri test revenue for the quarter grew 24% year-over-year to $42.6 million. Galleri test volume for the quarter grew 35% year-over-year to more than 61,000. Galleri test revenue in the first half of 2026 grew 30% year-over-year to $82.5 million. Galleri test volume in the first half of 2026 grew 42% year-over-year to more than 117,000. Net loss for the second quarter was $110.2 million. Gross loss was $12.6 million. Non-GAAP adjusted gross profit was $21.6 million, and non-GAAP adjusted EBITDA was $(90.3) million.1 "GRAIL continues to execute across our clinical and commercial priorities. We presented detailed performance, safety, and clinical utility results from the NHS-Galleri and PATHFINDER 2 studies at the 2026 American Society of Clinical Oncology Annual Meeting, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies in the screening population. We also expanded access through new and existing partnerships," said Josh Ofman, Chief Executive Officer at GRAIL. "Following our PMA submission earlier this year, we anticipate an FDA advisory committee in the fall." For the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, GRAIL reported: Revenue: Total revenue, comprised of screening and development services revenue, was $44.7 million, an increase of $9.1 million or 26%. Net loss: Net loss was $110.2 million, an improvement of $3.7 million or 3%. Gross loss: Gross loss was $12.6 million, an improvement of $5.2 million or 29%. Adjusted gross profit1: Adjusted gross profit was $21.6 million, an increase of $5.4 million or 34%. Adjusted EBITDA1: Adjusted EBITDA was $(90.3) million, an increase in adjusted EBITDA loss of $11.9 million or 15%. Cash position: Cash, cash equivalents, and short-term marketable securities totaled $861.6 million as of June 30, 2026. Recent business highlights include: Presented detailed results from the two largest multi-cancer early detection (MCED) studies completed to date, NHS-Galleri and PATHFINDER 2, at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in May. Completed the expansion of our field sales and medical teams to continue to drive commercial momentum for the Galleri test. Announced a collaboration with Priority Health to make the Galleri test available to its self-insured employer groups, making it the first Michigan health plan to enable employer groups to add Galleri to their existing cancer screening coverage. The health plan serves more than 1.4 million members across Michigan and beyond and previously launched coverage for Galleri in its Thrive and Thrive Plus Medicare Advantage plans in 2025. In June, GRAIL completed a previously announced $110 million equity financing with Samsung C&T Corporation and Samsung Electronics Co., Ltd. through the purchase of GRAIL common stock. GRAIL and Samsung C&T intend to collaborate to commercialize the Galleri test in South Korea, with the potential to expand into additional Asian markets, including Japan and Singapore, subject to regulatory approvals and other conditions. GRAIL anticipates the U.S. Food and Drug Administration (FDA) will hold an advisory committee in the fall to review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection blood test. The PMA submission is focused on test performance and safety results from 25,000 consented participants in the U.S.-based PATHFINDER 2 study with one year of follow-up and from the prevalent screening round (first year) of the 140,000-participant NHS-Galleri trial, the largest, and only, randomized, controlled intended use trial of any MCED test. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in clinical trials to the updated version that has been submitted to the FDA for pre-market approval. Conference Call and WebcastA webcast and conference call will be held today, August 5, 2026, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL's website at investors.grail.com. A replay of the webcast will be available on GRAIL's website for 30 days. About GRAILGRAIL, Inc. is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL's common stock is listed under the ticker symbol "GRAL" on the Nasdaq Stock Exchange. For more information, visit grail.com. About Galleri® The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others. The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. 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 (PSA) 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. For more information, visit galleri.com. Laboratory/Test InformationGRAIL's 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 U.S. Food and Drug Administration. GRAIL's clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes. Non-GAAP DisclosureIn addition to our financial results provided throughout this press release that are determined in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release also includes financial measures that are not calculated in accordance with GAAP. Our non-GAAP financial disclosure includes Adjusted Gross Profit and Adjusted EBITDA. We encourage investors to carefully consider our results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations. Adjusted Gross Profit is a key performance measure that our management uses to assess our operational performance, as it represents the results of revenues and direct costs, which are key components of our operations. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it reflects the gross profitability of our operations, and excludes the costs associated with our sales and marketing, product development, general and administrative activities and the impact of our financing methods and income taxes.We calculate Adjusted Gross Profit as gross profit (loss) (as defined below) adjusted to exclude amortization of intangible assets and stock-based compensation allocated to cost of revenue. Adjusted Gross Profit should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other GAAP measures of income (loss) or profitability. Gross profit (loss) (as defined below) is the most directly comparable financial measure calculated in accordance with GAAP. Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it provides a comparable overview of our operations across historical periods. In addition, we believe that providing Adjusted EBITDA, together with a reconciliation of net loss to Adjusted EBITDA, helps investors make comparisons between our company and other companies that may have different capital structures, different tax rates, different operational and ownership histories, and/or different forms of employee compensation.Adjusted EBITDA is used by our management team as an additional measure of our performance for purposes of business decision-making, including managing expenditures. Period-to-period comparisons of Adjusted EBITDA help our management identify additional trends in our financial results that may not be shown solely by period-to-period comparisons of net income (loss) or income (loss) from operations. Our management recognizes that Adjusted EBITDA has inherent limitations because of the excluded items, and may not be directly comparable to similarly titled metrics used by other companies.The Company defines Adjusted EBITDA as net loss adjusted for amortization of intangible assets, stock-based compensation, depreciation, intangible and other assets impairment, benefit from income taxes, interest income and restructuring expenses. These adjustments include non-cash items, significant non-recurring charges and/or other non-operating expenses that we do not believe are indicative of ongoing or future business operations.Adjusted EBITDA should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other U.S. GAAP measures of income (loss). Additionally, it is not intended to be a measure of free cash flow for management's discretionary use, as it does not consider certain cash requirements such as interest and tax payments. Further, our definition of Adjusted EBITDA may differ from similarly titled measures used by other companies and therefore may not be comparable among companies. Net loss is the most directly comparable financial measure calculated in accordance with GAAP. Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in tabular form following the Condensed Consolidated Balance Sheets and Condensed Consolidated Statements of Operations. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of our future financial performance, future tests or products, patient awareness of our products, technology, clinical studies, planned presentations at upcoming conferences, safety results, regulatory compliance and timing of regulatory reviews, potential market opportunity, anticipated growth strategies, strategic collaborations and planned expansion into Asian markets, restructuring costs, sufficiency of cash on hand to finance our business, cost savings, budgets and strategies, planned integration with EHR systems, and growth and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the sections entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025 and in the Quarterly Report on Form 10-Q that we plan to file for the period ended June 30, 2026. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make. Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events. View original content to download multimedia:https://www.prnewswire.com/news-releases/grail-reports-second-quarter-2026-financial-results-302844143.html

Jazz Pharmaceuticals (JAZZ) came out with quarterly earnings of $5.71 per share, missing the Zacks Consensus Estimate of $6.04 per share. This compares to a loss of $8.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -5.46%. A quarter ago, it was expected that this drugmaker would post earnings of $4.67 per share when it actually produced earnings of $6.34, delivering a surprise of +35.76%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Jazz, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $1.21 billion for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 9.33%. This compares to year-ago revenues of $1.05 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Jazz shares have added about 48.7% since the beginning of the year versus the S&P 500's gain of 9.4%. While Jazz has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Jazz was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $6.29 on $1.15 billion in revenues for the coming quarter and $25.56 on $4.49 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Grail (GRAL), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 5. This company is expected to post quarterly loss of $2.91 per share in its upcoming report, which represents a year-over-year change of +8.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Grail's revenues are expected to be $42.65 million, up 20% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report GRAIL, Inc. (GRAL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The Galleri Multi-Cancer Early Detection (MCED) Test Increased Cancer Detection 6.5 Fold When Added to Recommended Screenings for Breast, Colorectal, Cervical and Lung Cancer 71% of the New Cancers Detected by the Galleri Test Were in Stages I-III MENLO PARK, Calif., May 31, 2026 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that positive performance and safety results from the analysis of the full 35,878 cohort of its registrational PATHFINDER 2 study are being presented during an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting[1]. The PATHFINDER 2 study evaluated the safety and performance of the Galleri® multi-cancer early detection (MCED) test when used alongside standard-of-care cancer screenings in the U.S. and Canada. The prospective PATHFINDER 2 study is the largest interventional study of an MCED in North America to date and includes 35,878 participants in a broad, intended-use population of adults aged 50 and older with no clinical suspicion of cancer. "Cancer outcomes depend not only on better treatments, but on finding cancer before it advances and spreads. Earlier detection can open the door to more treatment options at any stage and increase the chance for cure," said Josh Ofman, MD, MSHS, President and CEO-Elect at GRAIL. "These PATHFINDER 2 results add to the growing body of clinical evidence in a large, representative intended-use population showing that the Galleri test can meaningfully increase cancer detection beyond recommended screening with strong performance and a highly favorable safety profile. Along with the NHS-Galleri trial results, these findings reinforce the clinical benefit of Galleri and its potential to transform early cancer detection at population scale." Galleri Increases the Number of Cancers Detected and Can Detect Them Early While effective screening improves early cancer detection, in the U.S., only 14% of all cancers are detected by guideline-recommended screening tests[2]. In PATHFINDER 2, 60% of diagnosed cancers were screen-detected (264/440). Adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a 6.5 fold increase in the number of cancers found by screening. Galleri detected nearly three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations). More than half (53.0%) of the new cancers detected by Galleri were stage I or II, and 71.3% of these have no USPSTF A and B recommended screening. More than two-thirds (70.9%) of the new cancers detected by Galleri were detected at stages I-III, when treatment with curative intent is more often possible. "PATHFINDER 2 provides important additional data on the performance and safety of MCED testing," said Karthik Giridhar, M.D., assistant professor of oncology at Mayo Clinic and a principal investigator on the PATHFINDER 2 study. "MCED tests are not a replacement for existing screening, but they have the potential to complement current approaches by helping detect cancer signals across multiple cancer types, including some for which routine screening is not currently available." Robust Performance Metrics Consistent with Previous Studies The Galleri test detected a cancer signal in 287 participants, and of those, cancer was diagnosed in 173 participants. The likelihood of receiving a cancer diagnosis following a positive test result (positive predictive value or PPV) was 60.3%, consistent with previously reported initial results of PATHFINDER 2 and higher than the first PATHFINDER study. 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 evaluated in the study. Galleri demonstrated strong performance, with 69.8% episode sensitivity for the 12 cancers responsible for two-thirds of cancer deaths in the U.S. For all cancers, episode sensitivity was 39.3%. Specificity was 99.6%, translating to a false positive rate of less than 0.4%. "The up to 6.5 fold improvement in screen-detected cancers with Galleri in PATHFINDER 2 study, coupled with the greater than 20% reduction in Stage 4 cancers observed in the NHS-Galleri trial, is really exciting data that help support Galleri's performance in a diverse and representative population," said Nima Nabavizadeh, MD, Associate Professor of Radiation Medicine at Oregon Health & Science University. "As an oncologist, I have seen too many patients diagnosed only after their cancer has spread, when treatment decisions become more difficult. By helping find more cancers earlier, when more treatment options may be available, there is great potential for multi-cancer early detection to transform cancer screening." Galleri Pinpoints Cancer Signal Origin Allowing Efficient Diagnostic Workups A key benefit of the Galleri test is its ability to predict where in the body the cancer signal is coming from. The PATHFINDER 2 study demonstrated that the test correctly identified the Cancer Signal Origin (CSO) 91.3% of the time, leading to efficient diagnostic workups. Diagnostic resolution took a median of 48 days, and only 0.6% of all safety-analyzable participants had an invasive procedure (213/35,335) following a positive MCED test result. A total of 90.5% of invasive procedures were nonsurgical. Screening with the Galleri test had a favorable safety profile, with a low false-positive rate and a low rate of invasive procedures. There were five study-related adverse events reported during diagnostic evaluation, only in those with cancer diagnosis. Anxiety temporarily increased for participants with a positive MCED test and subsequent cancer diagnosis, and returned to baseline by 12 months, as has been observed for other screening tests. One serious adverse event related to the diagnostic work-up was identified after the data lock. Follow-up is ongoing; this and any other findings after data lock will be reported in full in the next interim analysis. About PATHFINDER 2 (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 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 Galleri MCED test across various measures, including PPV, negative predictive value (NPV), episode 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. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes over several time points, including an assessment of participants' anxiety and satisfaction with the MCED test. About GRAILGRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, Calif. with locations in Washington, D.C., North Carolina, and the United Kingdom. For more information, visit grail.com. About Galleri®The Galleri® multi-cancer early detection (MCED) test screens for more than 50 cancer types, including many deadly cancers that currently lack screening options, such as pancreatic, ovarian and liver/bile duct cancers[3]. The Galleri test is the only MCED test clinically proven through a randomized controlled trial to increase earlier cancer detection (Stage I-III) and reduce Stage IV diagnoses - enabling more patients to have curative treatment[4]. When added to standard-of-care screening, the Galleri test reduced Stage IV diagnosis by more than 20% after the first year of screening across all stageable cancers4,*. The Galleri test increased cancer detection by screening four times versus standard of care screening alone4. The Galleri test has the lowest false positive rate among MCED tests** and the ability to predict the Cancer Signal of Origin with greater than 90% accuracy, helping guide efficient diagnostic evaluation1,4,[5]. The Galleri test is backed by a robust evidence program, with more than 380,000 participants across multiple studies, including the NHS-Galleri trial, the first and only randomized controlled trial for an MCED test. The Galleri test has delivered consistent performance across these studies. 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 (PSA) 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. For more information, visit galleri.com. *A statistically significant reduction was not observed in combined stage III–IV diagnoses across three screening rounds for the 12 deadly cancers. **Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance. Important Galleri Safety InformationThe Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. 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 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 (a cancer signal detected when cancer is not present) and false negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. Laboratory/Test InformationThe 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 GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes. GRAIL Forward Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include statements related to the potential benefits, uses and impacts of the Galleri test, extrapolation of trends in the results, comparability of the results to a real world setting, benefits of population screening with Galleri, the applicability of the PATHFINDER 2 results to the commercial or FDA versions of the Galleri test, and plans to submit the results for publication, among others. These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2025. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make. Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results, financial condition and success in our business strategies and operations may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events. [1] Giridhar K, et al. Safety and Performance Results From PATHFINDER 2 (PF2), a Registrational Study of a Multi-Cancer Early Detection (MCED) Test in an Intended-Use Population [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29-June 2 [2] NORC at the University of Chicago. Percent of cancers detected by screening in the U.S. https://cancerdetection.norc.org/ (2022). [3] Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806 [4] Swanton C. NHS-Galleri: Primary Results From a Randomised Controlled Trial to Assess the Clinical Utility of a Multi-Cancer Early Detection (MCED) Test in Population Screening [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29-June 2. [5] GRAIL, Inc. False positive rate. [Data on file: GR-2025-0256] View original content to download multimedia:https://www.prnewswire.com/news-releases/grail-presents-pathfinder-2-results-of-more-than-35-000-participants-showing-the-galleri-test-substantially-increased-cancer-detection-with-robust-performance-and-favorable-safety-at-2026-asco-annual-meeting-302786352.html

No Reduction Observed in Combined Primary Endpoint of Stage III/IV Cancers in Aggregate; However, Decreases Observed Beyond the Prevalent Screening Round Annual Galleri® Blood Test Reduced Stage IV Diagnoses of 12 Prespecified Cancers by 22% and 26% in the Second and Third Screening Rounds, Respectively Galleri Increased Cancer Detection Rate by Four-Fold When Added to Standard of Care Screening and Reduced Cancer Diagnosis Through Emergency Presentation by 25% Annual Testing With Galleri Increased Stage I-II Cancer Diagnoses by 16% When Added to Standard of Care GRAIL to Host Analyst Call From 2026 ASCO Annual Meeting MENLO PARK, Calif., May 30, 2026 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced detailed clinical utility, performance and safety results from its landmark NHS-Galleri trial in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting1. The NHS-Galleri trial is the first and only randomized, controlled trial of a multi-cancer early detection (MCED) test and evaluated annual screening with the Galleri ® test in England's National Health Service (NHS) over three years in 142,250 demographically representative participants aged 50 to 77 at enrollment. GRAIL collaborated with NHS England on the objectives of this study, based on NHS priorities to reduce Stage III and IV cancers. "The goal of multi-cancer early detection is to find more cancers earlier, when they are more treatable and potentially curable, so that patients have the chance of living longer and more productive lives," said Josh Ofman, MD, MSHS, President and CEO-Elect at GRAIL. "The NHS-Galleri trial provides a wealth of data that support the use of the Galleri test to reduce the burden of metastatic Stage IV cancer and increase the number of cancers found earlier through screening at population scale. Importantly, Galleri found more Stage I and II cancers than all cancers found through NHS' existing single cancer screenings combined. By the third round of screening in this trial, Stage IV cancer diagnoses fell by more than a quarter, when treatment with curative intent may be possible." Finding Cancers EarlierThe NHS-Galleri trial evaluated a combined primary endpoint of Stage III and IV diagnoses in a pre-specified group of 12 deadly cancers2 when the Galleri test was added to standard of care screening in England (breast, bowel, cervical and high risk lung cancers) versus standard of care screening alone; however, there was no statistically significant difference within a 1-year follow up window after the last appointment. Follow-up will continue, with further results published as available. Sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs at GRAIL, explained the reasons behind the Stage III and IV result: "We saw a substantial decrease in Stage IV cancers, but this was outweighed by an overall increase in the number of Stage III cancers, particularly in the prevalent screening round. We believe the Stage III increase was driven in part by a number of Stage IV cancers being shifted to earlier stages, including at Stage III, and the fact that many more cancers overall were found earlier through screening in the intervention arm, while the equivalent cancers may not yet have been diagnosed in the control arm. We would expect to see more of these as yet undiagnosed late stage cancers being found in the control arm with longer follow up. In addition, the trial has revealed just how much undiagnosed and uninvestigated Stage III cancer is already prevalent in the population before any screening commences. Finding these cancers earlier means we can start treating those patients with the urgency needed and, in many cases, with the opportunity of curative intent." One of the aims of screening is to reduce the incidence of metastatic late stage cancer. In the Galleri arm, Stage IV cancer diagnoses decreased with each year of sequential screening, with a 9% reduction in the first ("prevalent") screening round, a 22% reduction in the second round, and a 26% reduction in the third round in the pre-specified group of 12 cancers. The prevalent round detects undiagnosed cancers already present in the population at the time of initial screening, while subsequent "incident" rounds detect cancers that develop or progress between screening rounds and become detectable. Thus, the incident rounds most closely approximate the likely steady-state impact of an annual screening program. Overall, in this pre-specified secondary endpoint, a 14% reduction in Stage IV cancers was observed. These results were nominally statistically significant. Similar reductions of 20% or more were observed in the second and third screening rounds for all stageable cancers. "As a lung cancer doctor, I see the clinical importance of diagnosing cancer at an earlier stage, when treatment is more likely to be curative," said Professor Charles Swanton, thoracic medical oncologist at University College London Hospital, and one of the NHS-Galleri trial's chief investigators. "The NHS-Galleri trial tested whether adding the Galleri blood test to NHS screening could reduce the combined number of cancers diagnosed at Stage III or IV over three years. The primary endpoint was not met. However, a pre-specified secondary endpoint did show a greater than 20% reduction in Stage IV cancers, with the effect strengthening by the third year of screening. The Stage IV reduction is clinically meaningful because for many cancers there is a real gulf in outlook between a Stage IV diagnosis and one caught earlier. The hope is that for more patients the conversation can be about treating cancer with curative intent rather than managing it palliatively." Within the overall trend of Stage IV reduction, in an exploratory analysis, meaningful reductions in Stage IV diagnoses were observed in cancer types where 5-year survival is substantially higher when diagnosed at Stage III versus IV. For example, Stage IV diagnoses were reduced by 57.1% in esophageal cancer and 34.4% in colorectal cancer in the incident rounds. The five-year survival rates in England are significantly higher in Stage III than Stage IV for each of these cancers: 24.7% vs 6.2% for esophageal cancer, 64.2% vs 11.0% for colorectal cancer. "For most cancer patients, there is a real difference between being diagnosed and being treated with a possibility of a cure versus being diagnosed at Stage IV and only being offered treatment that could manage symptoms and side effects or potentially prolong life for months or a few years. This is why it is critical to detect cancer at earlier stages, especially before distant metastases. Patients live longer when they are diagnosed before their cancer spreads to other parts of the body," said Sally Werner, RN, BSN, MSHA, Chief Executive Officer at Cancer Support Community, a global nonprofit advocacy organization. "The Galleri study results show promise and bring hope to people concerned about cancer that it might be detected earlier, improving patient outcomes and allowing more patients treatment options that offer potential cures. The fact that this screening is available with a simple blood test that could be done at any healthcare visit could make this a game changer in increased screening and earlier diagnosis, which could reduce a large portion of the persistent cancer disparities we see." Relative Incidence Rate of Combined Stage III/IV Cancers Decreased After the First Round of Screening in the Pre-Specified Group of 12 Cancers; Relative Incidence Rate of Stage IV Cancers Decreased Each Screening Round. Along with the decrease in Stage IV cancer incidence, Stage I and II cancers diagnosed increased by 16% for the 12 prespecified cancer types after three rounds of screening, including large increases in many types typically diagnosed late, such as ovarian, esophageal, pancreatic and liver cancers. Nigel, 70, from the North East of England, took part in the NHS-Galleri trial and was diagnosed with Stage I head and neck cancer after receiving a cancer signal detected Galleri test result. "The fact that the cancer was Stage I meant it had likely been caught much earlier than would have otherwise been the case," Nigel said. "The surgery was less invasive, so that aided my recovery. And the horror stories I was presented with about the number of days in hospital and having to learn to drink and eat again - luckily none of that happened in my case." Finding More Cancers With Robust Performance and Favorable SafetyThe addition of the Galleri test to standard-of-care cancer screenings led to a four-fold increase in screen-detected cancers and a 21% decrease in the number of clinically detected cancers after symptomatic presentation. Further, the addition of MCED screening was associated with cancers diagnosed after emergency presentation decreasing by 25%. Eric Sue, M.D., a primary care physician of internal medicine at the Sue Medical Group in Los Angeles, noted: "There is a distinct difference between the objectives of a therapeutic drug trial and those of a cancer screening trial, where the totality of the data must be carefully considered. In the NHS-Galleri trial, the observed greater than 20% reduction in stage IV cancer diagnoses and the four-fold increase in cancer detection compared with standard screening alone are both highly compelling findings. Shifting cancers away from metastatic presentation toward earlier-stage detection—while identifying substantially more cancers overall—creates more opportunities to intervene when curative treatment may still be possible and, most importantly, where the opportunity to reduce cancer mortality may be greatest." 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. Over three screening rounds, 1,801 participants (0.91%) had a positive MCED test result and 937 were diagnosed with cancer, for a cancer detection rate of 0.48%. PPV was 52.0% overall and 58.0% in the first screening round. Specificity was 99.55%, resulting in a low false positive rate of 0.45%. CSO accuracy was 92.5%. Episode sensitivity – the ability to detect cancers that were diagnosed within 12 months after each Galleri screening blood draw - was 54.7% for the 12 prespecified cancer types and 30.7% across all cancer types. "Our current recommended screening tests only find around 14% of newly diagnosed cancers each year in the US and around 6% in England. In finding four times as many cancers compared to the standard screening programs combined, we are identifying many more asymptomatic patients with undiagnosed disease months or even years earlier than currently possible," said Kumar. "Galleri represents a potential transformational shift in cancer detection, moving us to a more comprehensive proactive approach. As treatment options continue to advance, screening frameworks must evolve in parallel. Multi-cancer early detection provides an opportunity to reshape screening around an evolving goal: detecting more cancers when there is an opportunity for cure." There were no serious related adverse events reported in the trial, reaffirming the safety profile of the test. The results of the NHS-Galleri trial will be submitted for publication in a peer-reviewed medical journal. "We are deeply grateful to the more than 142,000 participants who took part in this study, as well as to the NHS, The Cancer Prevention Trials Unit at Queen Mary University of London, Cancer Alliances, investigators, and clinical teams whose dedication made this landmark trial possible," said Professor Richard Neal, Professor of Primary Care at University of Exeter, General Practitioner, St. Leonard's Practice, and one of the NHS-Galleri trial's chief investigators. GRAIL to Host Analyst Call From 2026 ASCO Annual Meeting GRAIL will host an analyst call to discuss clinical study results presented at ASCO tomorrow, Sunday, May 31, 2026, beginning at 4 p.m. PT/6 p.m. CT. A link to the live webcast and recorded replay will be available at the investor relations section of GRAIL's website at investors.grail.com. Please register for the live event at https://grail-asco-2026-analyst-call.open-exchange.net/. About the NHS-Galleri Trial (NCT05611632; ISRCTN91431511)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. The trial recruited more than 140,000 asymptomatic participants, aged 50 to 77, and was conducted in partnership with the NHS in England. Participants provided three blood samples over two years, about 12 months apart. The primary objective of the NHS-Galleri trial was to show a reduction in late-stage (III-IV) cancers in people who received the Galleri test compared with those who did not. This was measured in three clinically important groups of cancers, focusing first in a pre-specified group of 12 cancer types that together represent approximately two-thirds of cancer deaths in England and the United States. Secondary objectives include reduction in stage IV cancer; performance of the Galleri test, including positive predictive value and false positive rate; increase in overall cancer detection rate; safety; and healthcare resource utilization. About GRAILGRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, Calif. with locations in Washington, D.C., North Carolina, and London. For more information, visit grail.com. About Galleri®The Galleri® multi-cancer early detection (MCED) test screens for more than 50 cancer types, including many deadly cancers that currently lack screening options, such as pancreatic, ovarian and liver/bile duct cancers3. The Galleri test is the only MCED test clinically proven through a randomized controlled trial to increase earlier cancer detection (Stage I-III) and reduce Stage IV diagnoses - enabling more patients to have curative treatment4. When added to standard-of-care screening, the Galleri test reduced Stage IV diagnosis by more than 20% after the first year of screening across all stageable cancers4,*. The Galleri test increased cancer detection by screening four times versus standard of care screening alone4. The Galleri test has the lowest false positive rate among MCED tests** and the ability to predict the Cancer Signal of Origin with greater than 90% accuracy, helping guide efficient diagnostic evaluation5,*. The Galleri test is backed by a robust clinical evidence program, with more than 380,000 participants across multiple studies, including the NHS-Galleri trial, the first and only randomized controlled trial for an MCED test. The Galleri test has delivered consistent performance across these studies. 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 (PSA) 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. For more information, visit galleri.com. **A statistically significant reduction was not observed in combined stage III–IV diagnoses across three screening rounds for the 12 deadly cancers. **Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance. Important Galleri Safety InformationThe Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. 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 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 (a cancer signal detected when cancer is not present) and false negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. Laboratory/Test InformationThe 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 GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes. GRAIL Forward Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include statements related to the potential benefits, uses and impacts of the Galleri test, plans for future follow up of the trial and expectations of future data or results we may see from such follow up, extrapolation of trends in the results, comparability of the results to a real world setting, including the similarity of the incidence rounds to steady state screening, the potential survival benefits of Galleri screening, benefits of population screening with Galleri, the applicability of the NHS-Galleri results to the commercial or FDA versions of the Galleri test, and plans to submit the results for publication, among others. These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2025. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make. Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results, financial condition and success in our business strategies and operations may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events. 1 Swanton C. NHS-Galleri: Primary Results From a Randomised Controlled Trial to Assess the Clinical Utility of a Multi-Cancer Early Detection (MCED) Test in Population Screening [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29-June 2.2 The 12 cancer types include anus, bladder, colorectal, esophagus, head and neck, liver/bile duct, lung, lymphoma, myeloma/plasma cell neoplasm, ovary, pancreas, stomach.3 Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.8064 Swanton C. NHS-Galleri: Primary Results From a Randomised Controlled Trial to Assess the Clinical Utility of a Multi-Cancer Early Detection (MCED) Test in Population Screening [presentation]. American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29-June 2.5 GRAIL, Inc. False positive rate. [Data on file: GR-2025-0256] View original content to download multimedia:https://www.prnewswire.com/news-releases/grail-reports-full-results-from-nhs-galleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnoses-at-2026-asco-annual-meeting-302786216.html

Never miss an important update on your stock portfolio and cut through the noise. Over 7 million investors trust Simply Wall St to stay informed where it matters for FREE. GRAIL’s modelled fair value sits at US$67.71, with recent research showing a wide range of price target moves, from cuts to around US$60 to fresh initiations with triple digit targets. These shifts align with the split in views after the NHS Galleri readout and ongoing questions around reimbursement, set against a very large estimated multi cancer early detection market of about US$70b. As you read on, you will see how these moving targets contribute to the evolving analyst story around the stock and what to watch next. Stay updated as the Fair Value for GRAIL shifts by adding it to your watchlist or portfolio. Alternatively, explore our Community to discover new perspectives on GRAIL. Baird, Canaccord, and TD Cowen have all referenced the estimated US$70b multi cancer early detection market. They see this as a key support for GRAIL’s long term opportunity even after near term volatility. Baird’s Outperform rating and earlier US$113 target, along with Canaccord’s Buy rating and prior US$105 target, indicate confidence that the Galleri test and upcoming milestones could support value over time despite recent headline pressure. Morgan Stanley cut its target to US$60 from US$110, citing the recent Q4 report, the NHS Galleri topline readout, and higher uncertainty around broad reimbursement. Taken together, these factors temper enthusiasm around the current valuation. Baird, Guggenheim, and other firms have reduced price targets after the NHS study missed its primary endpoint, highlighting execution risk around clinical outcomes and the timing and breadth of potential adoption. Do your thoughts align with the Bull or Bear Analysts? Perhaps you think there's more to the story. Head to the Simply Wall St Community to discover more perspectives! We've flagged 5 risks for GRAIL. See which could impact your investment. GRAIL reported topline results from the randomized NHS Galleri trial in 142,000 participants. The primary endpoint of reducing Stage III to IV cancers was not met, while pre specified analyses showed fewer Stage IV diagnoses and more Stage I to II detections in 12 deadly cancers, plus fewer emergency presentations. The company announced a collaboration with Epic to integrate the Galleri test into Epic's EHR platform via Epic Aura, with implementation planning set for early 2026 and broad availability targeted by the end of 2026. GRAIL entered a collaboration with Junction so healthcare organizations can order Galleri across digital health platforms, using Junction's diagnostic infrastructure and embedded physician network. Superpower and GRAIL agreed to offer the Galleri test to Superpower members nationwide, integrating it into a preventive health platform alongside a large biomarker panel, AI supported insights, and care teams. Fair value remains at US$67.71, with no change in the modelled output. Assumed revenue growth moves from 24.97% to 25.81% in the projections. Assumed net profit margin adjusts from 14.82% to 13.23% over the forecast period. The future P/E multiple shifts from 97.92x to 101.27x on projected earnings. The discount rate moves from 7.19% to 7.15% in the updated model. Narratives connect a company's clinical, commercial, and financial story to a forward looking model and fair value. They update when new trial data, partnerships, or guidance change the risk and reward balance. Head over to the Simply Wall St Community and follow the Narrative on GRAIL to stay up to date on: How clinical data for Galleri and large scale studies such as the NHS trial feed into expectations for regulatory progress and payer reimbursement. What expanding commercial adoption, repeat testing behavior, and platform collaborations mean for potential revenue growth and operating leverage. Key execution risks, including high ongoing losses and cash burn, margin pressure from pricing and automation issues, and competition in multi cancer early detection. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include GRAL. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]