GRAIL, Inc. (GRAL) Earnings Call Transcript & Summary
September 9, 2025
Earnings Call Speaker Segments
Yuko Oku
AnalystsHi, everyone. I'm Yuko Oku, and I'm on the life science tools and diagnostics team at Morgan Stanley. Before we kick it off for important disclosures, please see Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales rep. With that, it's my pleasure to host GRAIL today. And from the company, we have CEO, Bob Ragusa; and CFO, Aaron Freidin. Thank you.
Yuko Oku
AnalystsOkay. To start, could you provide a quick overview of GRAIL's mission for folks that are not as familiar with the story? And what are you focused on over the next 12 months?
Robert Ragusa
ExecutivesSure. And first of all, thank you for -- thank you, Yuko, for having us as well as the Morgan Stanley team. GRAIL's mission is to detect cancer early when it can be cured. And 70% of the cancers that are out there are not [ going to look for ]. So standard of care screening looks for about 30% of the cancers that are the -- cancers that cause 30% of the death. Galleri is really looking at -- looking for those other 70% of the cancers. And so for example, in the PATHFINDER study, when we added Galleri to standard of care screening, we found we more than doubled the number of cancers found. We did a very high positive predictive value of 43%, very low false positive rate of 0.5%. And we also provided a cancer signal of origin with a high accuracy of around 90%. And so right from the beginning, Galleri has been designed as a population scale screening test. And part of the reason for that is we recognize the numbers here are enormous. So if you look at the TAM in the U.S., there's about 100 million individuals who are screening eligible for a multi-cancer early detection test. If you go to the U.K., where we're running the NHS Galleri study, there's another 19 million. Across the EU, there's another 160 million. And even, for example, in Japan, there's almost 50 million. So really large numbers. So a lot of -- all the things we've done for this are really geared towards population scale screening. And so what we're looking forward to the next 12 months. So we've just read out over the summer, our NHS Galleri study, where we found substantially higher positive predictive value than PATHFINDER. So PATHFINDER s already at 43%. In our PATHFINDER-2 study, we gave the top line results, again, substantially higher positive predictive value and higher cancer detection rate. And in both studies, the specificity or false positive rate was consistent as well as the cancer signal of origin accuracy was very consistent and no adverse events in those studies. So we're really looking forward to it. We submitted and are hopeful we'll be able to present at ESMO in October with our PATHFINDER-2 full data readout. And then in the middle of next year, the full readout on the NHS Galleri study. So again, PATHFINDER-2 was 35,000 people and NHS Galleri 140,000 people. So large studies. And then the other big thing next year is we're looking in the first half of 2026 to submit our final module for our PMA to the FDA.
Yuko Oku
AnalystsGreat. A lot to dig in there. So maybe starting off with the competitive landscape. You're first to market in the multi-cancer screening space. Could you elaborate on the competitive landscape today and how you see Galleri positioned? And sort of related to that, one of your competitors launched an MCD at a lower list price versus Galleri. Does that pressure your ASP at all?
Robert Ragusa
ExecutivesYes. So a couple of things there. So first of all, kind of our first-mover advantage. We look again, the test was designed and built for population scale. So we believe from a performance standpoint, we're in really good shape. We also have the largest clinical study. So we studied nearly 400,000 people across all our studies. And then in the more recent studies, PATHFINDER 6,600 people, PATHFINDER-2 35,000 and NHS Galleri 140,000. So really large studies. So we have a lot of data in interventional studies prospectively in the intended use population. And then the third piece from a competitive standpoint is just our commercial experience. So we've been out there for more than 4 years. We understand what works and doesn't work. We understand how to integrate it into a clinical practice, what are the important elements. And so some of the things to think about there is the low false positive rate, the high positive predictive value. So high positive predictive value gets you to very actionable results. So when providers see a positive on Galleri, they know that there's something that you really have to go look at, as opposed to some of the other screens, which are low single-digit positive predictive values. So that's an important aspect. And then the other thing is just the cancer signal of origin to have a cancer signal of origin is really a differentiator. It's what helps guide an efficient diagnostic workup for it. Then you mentioned ASP pressure and new entries in the market. So if you look at the tests coming out, one in particular with Cancerguard, we feel really comfortable about our -- again, it's the suite of metrics that make it for a population scale screen. So the fact that we have high sensitivity and good cancer detection rate. So again, doubling the number of cancers found compared to standard of care, the very low false positive rate, the high positive predictive value and the cancer signal of origin capability. And so when you look at just the specifications and compare one to another, if you take 97.4% published specificity for the other tests and you look at 99.5% of Galleri, on the surface it doesn't seem like that big a difference. When you dig into the details, that's a more than 5x degradation in false positive rate as you go from 99.5% to 97.4%. And again, since we were designed for population scale, we're looking at big numbers. So if you look at 1 million people, that means with the Galleri test, you're looking at 5,000 false positives. With the other tests, you're looking at more than 25,000 false positives. And then if you couple in the cancer signal of origin guides, the directed workup. So you have an efficient workup on the Galleri side. On the other side, there is no cancer signal of origin. So you have more than 25,000 with a non-guided workup. So we feel good about the competitive landscape. And we think our performance, coupled with our -- all the studies. So we're the -- Galleri is the only NSAID with demonstrated performance in individuals being screened for cancer in the intended use population. So coupling performance in our studies, we feel really good about our competitive position and our ability to be priced to where we are.
Yuko Oku
AnalystsGreat. So you mentioned a lot of the pros of being a first-mover advantage. But one of the cons you can say is that you have to pave your way for reimbursement, right? So when you were thinking about potentially developing multi-cancer tests versus a single cancer test and then taking a multi-cancer approach after that, like what are the criteria? Or what are you thinking around that?
Robert Ragusa
ExecutivesYes. So again, we've looked at through GRAIL's history, looked at kind of all combinations to get in there. And we really focused on multi-cancer because that's ultimately is where the need was. Again, if you look at -- you have -- it's always meant to be a complement to standard of care screening and standard of care does a good job of looking at the 30% of the -- cancers that cause 30% of the deaths. So really comprehensively look at the other 70%, we found it impractical to go cancer by cancer because there are so many cancers that make up that huge long tail. And the reality is in the early discoveries, we found a shared cancer signal across those. And so that really points us towards the NSAID. There have been some forays to try to use a single cancer test to get reimbursed for a multi-cancer test. And we think that raises a lot of questions. We're hearing at this conference, we heard in the previous conference to some of the questions around that strategy. So not for me to go into detail on that. That's another company's strategy, but we'll be looking to see what happens there. But I think when you're evaluating any -- whether it's single cancer, multi-cancer, you really have to look at the data, how much data is there in the intended use population. And again, here's where we've spent a lot of effort across really large studies to really understand how the test performs in intended use. And we've been really pleased that our case control data translated into PATHFINDER very well, and it's also translated into very large NHS Galleri studies and PATHFINDER-2 of 35,000, 140,000 people. It's unusual for the performance to actually get better in those studies. A lot of times, you see when it goes from case control to the intended use population that degrades. We've been very happy with the fact that it's at least replicated in the latter 2 cases gotten better.
Yuko Oku
AnalystsOkay. Great. Well, let's dig into those results. You recently announced the top line results for PATHFINDER-2, which demonstrated substantially higher PPD and cancer detection than PATHFINDER. So ahead of the detailed results at ESMO. Could you provide a high-level overview of the trial design and key aims of the trial? Given this is one of the key data that will be part of your PMA submission in first half '26, what are the regulators focused on in the study?
Aaron Freidin
ExecutivesYuko, as you said, the study was designed and is part of our registrational clinical package to go to the FDA. PATHFINDER-2 is designed as a safety and performance study in the U.S., it's 35,000 folks in the total, one time point, one test and then followed for a year. That period expired. We're now going to present that data next -- at ESMO, and we're excited about that. We enrolled that study to be very -- to look like the intended use population, right, to specific -- the right demographics, the right ethnic mix, socioeconomic mix and so on. And I think that's why you're actually seeing the performance in PPV, as we said, improve. It looks more like the intended use population. And so we'll be submitting that as we said at ESMO. We'll -- as we said earlier, the PPV is substantially greater. Specificity is in line with what we had previously said in PATHFINDER, so the cancer signal origin. The other really important part is that we've improved the number of cancers found when compared to the standard of care, when compared to PATHFINDER. So PATHFINDER was more than 2x. We're now -- we're greater than that, which is really important as you think about cancer yield. And so we think the FDA -- what we know what the FDA is going to look at is benefits and harms. They look at the performance. As they've looked at our performance in our prior studies, they were done under IDE. So the FDA has been on this journey with us since 2019 when we were in breakthrough with them. And we're excited to get this data in their hands.
Yuko Oku
AnalystsWhat are some of the reasons that PATHFINDER-2 may have shown a higher cancer detection rate in PPD than the prior PATHFINDER trial? Are there any key differences between trial design or population enrolled in the study?
Robert Ragusa
ExecutivesYes. that's exactly where it's at. And PATHFINDER-1 was enrolled. It was enrolled during the pandemic, and it was a highly screened population. There's very well known that certain populations like to get screened more than others. With PATHFINDER-2, we really took the time to make sure that we weren't focused on a highly screened population that we're looking at what the world looks like, who's not getting screened that should, but still asymptomatic, no symptoms for cancer and so on. So that test performance, I think, is really more representative of what the world actually looks like when it comes to cancer versus what folks who enroll in these studies can sometimes look like.
Yuko Oku
AnalystsOkay. Given that physicians should have had more time to gain clinical experience with Galleri versus when the original PATHFINDER study was run, is there a potential for a diagnostic resolution to be shorter than the 57 days for those with positive signal, 162 days median diagnostic resolution for false positive results seen in the prior study? And then will we see these metrics with the detailed results at ESMO?
Robert Ragusa
ExecutivesYes. So it is one of the endpoints that we presented at ESMO. And again, if you recall, that follow-up was all done during the pandemic. So we'll see what it looks like when it comes out and we present it. We do these qualitative releases, not because we don't want to get the data out there, but if we put the data out there, we're not going to be able to go present it at one of these large conferences, which we think is really important. It's a great -- it's where you want to present this type of data. So we'll see it all then.
Yuko Oku
AnalystsOkay. All right. Looking forward to it. All right. So I want to jump into NHS Galleri. You shared top line results from NHS Galleri trial as well, which also showed substantially higher PPV in the first round of blood draws than observed in PATHFINDER, though PPV may decline in the subsequent blood draws. Similar to the question on PATHFINDER-2, are there any key differences in the population enrolled in NHS Galleri, or is -- or its design that may have driven PPV higher than in the PATHFINDER?
Robert Ragusa
ExecutivesYes, it's a good question. So in NHS Galleri, similar to PATHFINDER-2, we went to extraordinary lengths to make sure that we had a population that was representative of the U.K. So we looked across ethnicity to make sure we had the match ethnicity mix as well as socioeconomic scale. So in the U.K., they actually have scales for in quadrants. And so we made sure those all match. So we're very comfortable that the population is very representative, likely one of the things that changed the incidents that would have impacted the PPV. Anytime you have that culling effect in the first round, you could have an impact on PPV as you go into future rounds. That's definitely a possibility. But the important element within the NHS Galleri that sets us aside is an interventional longitudinal 3-year study with a year of follow-up. So it's actually looking for clinical utility. So we're looking for stage shifts, so reduction in late-stage cancers in the intervention arm compared to the control arm. So look at Stage 3 and 4 reduction versus the control arm as well as the Stage 4 reduction versus the control arm. So we should be able to get a measure of clinical utility out of that. And that will all come out in the middle of next year.
Yuko Oku
AnalystsGreat. And I know you said previously that regulators aren't focused on the clinical utility aspect of NHS Galleri, but it is important for payer conversation and physician buy-in, right? So outside of NHS Galleri, what other clinical utility studies are underway that you believe are important from a reimbursement perspective?
Robert Ragusa
ExecutivesSure. So the REACH study in the U.S. in the Medicare population. So this is 50,000 people, again, over 3 years, similar to the NHS. It will be compared against a synthetic comparator arm. So -- but the intervention arm is 50,000 people. So that will generate, again, the clinical utility data in the U.S. Medicare population that should be able to be used for payer discussions. So we're looking forward to that data as well in the future.
Yuko Oku
AnalystsGreat. And do you have an estimated time line for when that would complete?
Robert Ragusa
ExecutivesThat one -- so we'll probably be through a lot of the milestones before that study is actually completed. So we'll probably look at using partial data out of that for actual payer discussions.
Yuko Oku
AnalystsGreat. Okay. So one of the things that KOLs are concerned about with NSAIDs in general is the potential that it would lead to lower adherence to existing screening products. Have there been any studies conducted to date to address that concern?
Robert Ragusa
ExecutivesYes. So it's kind of again from the beginning realm when we recognize you want to have a population scale screened, and we recognize the goodness that are in standard of care screen. So we've never really been targeting to try to replace those, that's really been as a complement to those. And so in PATHFINDER, one of the things we measured is the people who are participating in it and got a Galleri screen, what was their likelihood of continuing on with their standard of care screening. And we're happy to see that the standard of care screening continued on quite well with that group. And so in PATHFINDER-2, that's also one of the readout elements we'll look at is what's been the inherent standard of care screening with people taking Galleri.
Yuko Oku
AnalystsGreat. And then the repeat order rate has been steadily increasing with 25% reorder rate in 2Q despite being ahead of any meaningful reimbursement. What are key drivers of the uptick in reorder rate in your view?
Aaron Freidin
ExecutivesYes. So we're really happy with the reorder rate being where it is at 25% for a non-reimbursed non-guideline test. People are really seeing the value on an annual basis of taking the test. And so the improvement in that is, I think, through more physician interaction, more physician understanding how to follow up on guidelines, doing more work, as Bob has said, in our studies we've shown, a PPV of over 40% is something that you need to follow up on as a clinician. When you compare it to mammography, which is around 5%. People who get -- I'm sure you've had mammograms and they say, you have a positive but don't worry about it, you're going to go get a follow-up. That's not what physicians tell people who have positive Galleri tests. So I think the more data we have, the more FDA approval we have, the more clinical utility have, I just see that number continuing to grow. But we're very happy with where it's at for it being an out-of-pocket test.
Yuko Oku
AnalystsAnother potential driver of volume for you is the 7% of orders coming in 2Q from the Quest platform. What's driving that growth? And how much volume do you think you will eventually see coming from the platform? And how could the platform also help you with further improving the repeat ordering rate?
Aaron Freidin
ExecutivesYes. The Quest partnership has been really, really great for us, and we're excited about it. We're still early days as far as some of the longer-term impact of it. But what we do know is where physicians have onboarded the Quest, we've seen those physicians ordering more tests. There's this theme I'm sure you guys are all aware of that barriers to getting testing, whether it's in any sort of health care, when you remove those barriers, make things easier for somebody to get a blood draw or order a test generally shows an improvement in the number of people ordering the test are compliant. So we're excited about where that's at. We're also now starting to see new physicians come on to the platform that are using Quest, but we're still in the early days of some of those integrations, but we're excited with what we've seen so far.
Yuko Oku
AnalystsDoes it also have additional features on the platform that sometimes it has alerts for ordering again when you're due for a next test. Is that some of the features that are available on that?
Aaron Freidin
ExecutivesSo we've seen those in some of the integrations that we've done with different EMRs. I don't know if Quest specifically has that or not. But we've seen different health systems where they have a flag for you should offer Galleri to this person or it's their turn to take it again. It helps the physician remember that they should offer it or ask.
Yuko Oku
AnalystsOkay. I know one of the things that is required for the PMA filing also is the bridging studies. So could you talk a little bit about the bridging studies that will be needed to support PMA approval, Galleri 2.0?
Aaron Freidin
ExecutivesSure. So we've talked about our new version of the test. The studies were run on the previous version. And so in the discussions with the FDA, we know we'll have to show a bridge between older version and the current version of the test that we're running. And so that's being integrated into the PMA process. So in the first half submission next year, we'll have that bridging information in there.
Yuko Oku
AnalystsHow large is the study required to be for bridging?
Aaron Freidin
ExecutivesYes. So that we're still working out with them. It will be substantial, but it will also be samples that we already have as opposed to going and getting new samples from the studies.
Yuko Oku
AnalystsGreat. So legislation is working its way through Congress and if passed grants the ability for CMS to cover Galleri test upon FDA approval. Can you provide an update on where that bill is in review and the next steps? And then also, could you provide an example of other screening paradigms that might have undergone the same process in establishing Medicare reimbursement?
Aaron Freidin
ExecutivesSure. Maybe starting with the second one, first. The colorectal screening, so quite a while back, colorectal screening law was passed to be able to enable CMS to be able to reimburse for that. And one of the key things you see in that field is just the level of innovation that's occurred in the ensuing decade after that to be able to really drive innovation in that field. And so that's part of the hope of the NSAID bill as well is not only -- it's not a GRAIL test, it's an NSAID legislation. And so really driving innovation and providing more certainty about reimbursement at the end of the game so that people can invest in innovation. But at the end of last year, we had -- it was in the package that was ultimately shot down by the 1,600 going to 160-page bill. But -- in that process, it came out of the House Ways and Means Committee at 38 to 0, so a unanimous vote in favor of it. As we look at it going again this year, we have more than half of the House, more than half of the Senate, and nearly 2/3, not only as supporters, but as cosponsors. So it's the third most cosponsored bill in Congress, and it's the #1 most cosponsored bill in health care. It also has about 700 advocacy groups that are pushing for its passage. And so we think it's positioned as well as it can be and now it's really looking for the right funding vehicle. So we're hopeful that it will occur this year, but obviously, a lot of it's outside of any of our control.
Yuko Oku
AnalystsShould the efforts to establish CMS statute fail to pass, you have another shot on goal. You can work through the USPSTF pathway following FDA approval to establish reimbursement. So how quickly following FDA approval could USPSTF review Galleri? And how do the recent headlines around potential dismissal of all members of USPSTF effect time lines?
Aaron Freidin
ExecutivesYes. So since USPSTF is a really important pathway for us, we obviously are pretty cognizant of change -- potential changes there. I don't think we have any more insight than what's been in the media in terms of what's actually going to happen there. But upon FDA approval, we would go pretty immediately to USPSTF to give the data and really show the impact on kind of the battle of cancer that a test like Galleri could provide and hopefully secure a strong recommendation of USPSTF.
Yuko Oku
AnalystsSince there isn't an established time line for USPSTF review for an NSAID in particular, when a new emerging technology comes to market, like how long does it typically take? Or do you have any prior examples of how we can think about those time lines?
Aaron Freidin
ExecutivesYes, I'm not sure we have any clear time line on that. NSAID is, as you say, a novel space. But the flip side of that is when you look at the impact that NSAIDs had and by the time they take it up, if you look at the level of impact in terms of Galleri test will be out there, the number of cancers we will have detected, the fact that it's FDA approved, we'll have all the studies behind us really showing both the benefit/harm ratio as well as the clinical utility benefit. So we think that will put a fair amount of pressure on being speedy in the process, just given the goodness and the impact on cancer it could have.
Yuko Oku
AnalystsOkay. There have also been some noise from KOL community that methylation-based early detection tests have limited ability to detect early-stage cancers. Remind us of the demonstrated Stage 1 sensitivity for Galleri. And is that sensitivity sufficient to justify benefit versus cost and risk in your view, why or why not?
Robert Ragusa
ExecutivesYes, happy to talk. So we've talked about PATHFINDER-2 or PATHFINDER. In PATHFINDER, we more than doubled the number of cancers found by the standard of care and more than half of those that we found were early-stage cancers, Stage I and II cancers. That's an intended use population study, not case controlled. We have case controlled data from CCGA that shows Stage 2 sensitivity of 70%, which are all cancers you can treat with curative intent. So I think we've got data that shows that we can find these early-stage cancers. And I think it's really important to focus on the fact that you don't know what cancers you're screening for, right? We're screening for cancer in your body. We're not going after a single cancer and then another cancer and so on. And you don't know what that incidence is, you don't know when you're going to find. So if you're -- so just looking at sensitivity by cancer by cancer, does that actually make sense? Or should you be looking at how many cancers are you finding with this test that currently aren't being found. And we're finding more than double the number of cancers found in PATHFINDER, and we've improved that ratio in PATHFINDER-2. And we've shown that those cancers are early stages. So I think we've got data that shows that we're finding early-stage cancers that you can treat with curative intent.
Yuko Oku
AnalystsOkay. Given the very large potential opportunity for Galleri, pricing could come under scrutiny or should it be ruled out broadly. What is -- what price point are you comfortable with where you can still achieve an attractive margin profile?
Aaron Freidin
ExecutivesYes. We built the version of the test that's on the market now and the PMA version to be a population scale test, as Bob has said, we built that with it -- will it have a low COGS and a fair margin at a lower price point than we're at today. If you think about the NSAID legislation that would peg the reimbursement for NSAID at $508 a test. We're comfortable with being in the 50% to 60% margin range at those prices. And with the platform we have today, we're currently able to run about -- the system is capable of running about 1 million tests a year. We're running at a fraction of that. So we've got significant fixed cost leverage to grow into. And we could -- if a bunch of demand showed up tomorrow, we'd be ready to handle it. So we expect the price to come down, and we're prepared for that.
Yuko Oku
AnalystsOkay. And through first half '25, more than 370,000 commercial Galleri tests have been ordered by more than 15,000 health care providers. Despite Galleri being essentially ahead of any reimbursement, you're guiding to 20% to 30% year-over-year screening revenue growth this year. What are the key drivers that will swing revenues to the high end versus the low end?
Aaron Freidin
ExecutivesYes. This year, we said we've guided 20% to 30%. Last year, we grew -- revenue grew in the Galleri for about 21%. Volume grew at just under 30%. And what we're seeing...
Robert Ragusa
ExecutivesLast quarter.
Aaron Freidin
ExecutivesThis past quarter. The -- what we're seeing drive that are a couple of different things. The telemedicine health wellness platforms are becoming more popular. We've got self-insured employers that we sell through, and that base is building. And also our PCPs through things like Quest and Athena Health are ordering more tests. We've got a TRICARE program, and we'll see how that goes. It's still too early to really say what that will contribute. And then there are some headwinds. We've got our first responders like firefighters and so on, they take the test, but that's usually connected to grant NIH-type money, we know what's happening in that world. But overall, we're confident that we're going to be in that 20% to 30% range for the year.
Yuko Oku
AnalystsGreat. And then where are you seeing the greatest volume growth to date in terms of channel, health care networks, self-insured employers, life insurance, self-pay.
Aaron Freidin
ExecutivesYes. I'd say it's the depth of our ordering base, our PCPs, again, through things like Quest and so on, getting it into their protocol because you've got to remember that the cancer incidence is about 1%. So if a physician orders 99 tests, they might not find a cancer. If they order 150, they might not find a cancer. But when they're finding them, then they're seeing that it works. They're seeing how it changes their patient's life and so on. We've got different programs put together to connect physicians who have lots of experience with new ones, and that's been successful as well. And I think I've already mentioned the wellness platforms as function health grows, we expect to grow.
Yuko Oku
AnalystsGreat. And outside Galleri, how should we think about development services business?
Aaron Freidin
ExecutivesYes, development services business is great, it represents our biopharma partnerships with folks like AZ, where we're working with them on their trials and their drug designs and so on. It's not a revenue line that we guide because it's quite lumpy and out of our control at times. But it is important work that we're doing with those partners. But I would expect it to be pretty -- our investment in that is pretty static, and I would expect the revenues to be pretty static.
Yuko Oku
AnalystsGreat. And then you also talked about doing more with less after the August 2024 restructuring. What efficiencies have you identified or learned? And what changes, if any, are expected in '26?
Aaron Freidin
ExecutivesYes. So in '25 -- '24, we effected that restructuring. And in '25, we've been working through our PMA module submission. And we've found that we've been able to stick to our time lines, targeting '26 for the final submission with 40% fewer resources. So the organization and our people, we've got some core values here, solve problems together, embrace change and so on. Our teams are doing a really great job of coming together to really change cancer outcomes for patients in the world. So from an execution standpoint, we're doing what we thought we would. And then financially, those I would expect in '25, when we're submitting the PMA submission. We've got -- as Bob said, we've got concordance bridging studies, clinical validation, analytical validation and so on. Those things will not repeat in 2026. So there'll be some R&D dollars that will free up. And then it will really be thinking about how we spend sales and marketing dollars. We've really been focusing on growing revenue efficiently. We're not chasing every gallery sale across the United States. We're really focusing on where we've seen success. And so if we're seeing more success there, we'll invest more dollars. But we really want those dollars to be capital efficient.
Yuko Oku
AnalystsGreat. With your Investor Day set for November, could you give us a little preview of what we might hear there?
Robert Ragusa
ExecutivesYes. So we're -- we scheduled an Investor Day for November 13. We're going to run that at our RTP site, Research Triangle Park site. That's where our main laboratory is, and so people will be able to see that. And throughout the day, we'll be able to talk about our studies that we've already done as well as the top line readouts. We'll also be able to, at that point, on PATHFINDER-2 go into more of the detail of the actual readout and for NHS Galleri, be able to frame up how the data -- how we're going to look at the data and so people get a better understanding of that. And then importantly, we'll be able to have investors hear directly from people who are current Galleri users, so they can hear firsthand experiences of Galleri users. So we think it will be a great day for people to get a much better feel of just the kind of size and scale of our operation as well as the clinical studies coming out and firsthand experience.
Yuko Oku
AnalystsGreat. And then just in the last couple of minutes here, I want to wrap up with a bigger picture question. What about GRAIL's story do you feel is underappreciated by investors?
Robert Ragusa
ExecutivesYes. So I think -- I'm not sure about underappreciated, but if we look -- if we kind of just look to the future, one of the big things we have coming out is what we've already done in terms of GRAIL being the only NSAID with demonstrated capability in the intended-to-us population of people being screened for cancer. We have -- mid next year, we have the readout on clinical utility. So it will be great to see out of the NHS Galleri study, the clinical utility. We'll be in process of FDA approval. So we submit in the first half of next year. We expect about a 1-year process for that to get the FDA approval. And then that really starts to unlock broader reimbursement, especially if it gets coupled with the NSAID bill. So we think those elements give a lot of great inflections. Even earlier on, we have the PATHFINDER-2 readout, which we'll have hopefully next month at ESMO. So a lot of good things there. And then I think maybe the underappreciated thing not through by investors, but in general is in all these things, we typically talk about the future, what's going to happen. And if you just look at what's happening now today, literally every week, every day, we're detecting cancer in asymptomatic people. So it's not a future thing. In the future, we'll detect a way more. But right now, we're detecting a substantial number of people every week. And it's changing patients' lives. It's changing the way providers practice medicine in cancer, and they're seeing things that they've never seen before. I mean, we've had physicians who are older than I am that have see of early-stage pancreatic cancer that say, I've never seen one of those. And so that change in patients' lives today is really impactful. I think that piece might be underappreciated.
Yuko Oku
AnalystsWell, that was great. Thank you so much. Well, thank you.
Aaron Freidin
ExecutivesThank you.
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Programmatic access to GRAIL, Inc. earnings transcripts and 32,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.