Good morning. Thank you all for joining us today. My name is Henry Jiang. I'm with the banking team here at J.P. Morgan, and it's my pleasure to be introducing the GRAIL team today. Joining me on stage and presenting today will be Bob Ragusa, CEO, and Dr. Josh Ofman, President. Just a quick note, we'll have time for Q&A at the end. And, excuse me, just please wait and we'll get you a microphone if you have any questions. But with that, I'll pass it over to you, Bob.
Thanks, Henry. Appreciate it.
Welcome and thank you for attending this session. I'm Bob Ragusa, Chief Executive Officer at GRAIL. We're pleased to be here to talk today about the company, the progress we've made as a company, and the exciting year ahead. Here are our disclaimers. Today I will share with you a business review, and then Dr. Josh Ofman, who joins me up on stage here, our President, will review Galleri's differentiation and future opportunities. We're immensely proud of the progress we've made as a company. We launched Galleri in 2021, enabling individuals and their physicians to identify cancers before symptoms appear, often at earlier stages. These cancers typically have no recommended screenings. We see ourselves as leaders in an expansive field.
We were the first to launch a multi-cancer early detection test, a brand new testing paradigm for cancer screening, and have been on the market for more than four years. Oops. Excuse me there, so we demonstrated the performance of the test through a number of studies, most recently in a readout of the first 25,000 participants in the PATHFINDER 2 study, where we showed strong performance. We are still the only multi-cancer early detection test that has presented and published data in the intended use population, which we believe is critical to understand the performance of an MCED test. We have completed more than 800,000 Galleri commercial and clinical tests and have sold more than 185 Galleri commercial tests in 2025. Our commercial experience and large clinical data sets put us in the position to continue to lead the space.
We generated between $147 million and $148 million in revenue, comprised primarily of Galleri test sales as well as development services sales to our biopharma partners. This opportunity is about scale, and we have invested in building our laboratory infrastructure to support it. At the end of 2024, we launched our new highly automated test process, which expanded capacity to about a million samples per year and allows for additional expansion with moderate capital expenditure. We are building the business with intention and are making significant progress towards adjusted gross margins in the 50%-60% range at scale. Based on our strong performance, we completed financing in Q4 of 2025 and ended the year in a strong capital position with $904 million of cash on the balance sheet. There are a lot of exciting things coming up for GRAIL.
We shared this fall that we expect to complete our filing of our PMA in the first quarter of 2026. We will present full data sets mid-year 2026 on the 140,000-person NHS-Galleri study and the 35-person PATHFINDER 2 study. From a commercial perspective, we expect to continue to expand Galleri in the United States as well as advance Galleri in international markets. We're at the very beginning of an exciting journey to fundamentally change the way we screen for cancer. In Q4 of 2025, we strengthened our balance sheet by raising approximately $435 million. We raised $325 million in a PIPE investment, and we were able to support additional demand, raising an additional $110 million through our ATM program. We also announced a $110 million equity investment by Samsung, which is expected to close this month.
These transactions provide us with financial flexibility to navigate our growth ramp over the next several years as we pursue critical milestones to support regulatory approval and broad access. We are seeing strong commercial momentum. In 2025, we saw strong Galleri growth volume of 35%, with total commercial test volume for the year of over 185,000 tests. Much of the increase is driven by both breadth and depth of prescribing in 2025. The prescriber base grew approximately 30% over 17,000 prescribers. We also saw continued growth in our repeat test rate, achieving over 30%, which gives us confidence that both physicians and patients are seeing value in the annual testing cadence. In 2025, we began leaning into the price elasticity that we see in the market, and we are finding success in expanding access with our discounting programs.
MCED is a new paradigm for screening, and we're working closely with a number of partners to drive market growth. This includes operational partners to support efficient ordering and test execution, health system partners to educate physicians, engage the community, and deploy testing in appropriate populations. Our digital health partners to enable access to curated memberships provide education and offer MCED testing and distributor partnerships to tap international markets. Over the last year, our operational partners, such as Quest and Athena, have effectively helped us develop an easy button to deploy for physician ordering, making a real impact to both prescribing depth and breadth. Our telemedicine provider, Recuro Health, helps us provide simple access to Galleri through galleri.com and supports workflow for a number of our employer customers. Our health system partners support implementation into screening populations and enabling real-world workups for positive tests and capturing and publishing real-world evidence.
Our digital health partners support access to large, self-pay populations who are focused on wellness and preventive healthcare. They also support connections with health systems to link patients and providers for any follow-up for positive tests. Our international distributors enable us to access patient populations outside the United States. Our distributor partners leverage their own local infrastructure and expertise to bring Galleri to their populations in a capital-efficient manner. So far, we've launched partnerships in Israel, Canada, and announced a partnership with Samsung in South Korea. We have a strong financial profile. We're focused on growing revenue and controlling spend. Revenue for full year 2025 is expected to be between $147 million and $148 million, approximately 17%-18% growth over 2024. We guided U.S. Galleri revenue to be up 20%-30% from 2024's revenue of $108.6 million. We expect full year 2025 U.S.
Galleri revenue will come in between $136 million and $137 million, a 25%-26% increase over 2024. For full year 2025, cash burn was approximately $274 million as compared to 2024 cash burn of $579 million. We achieved this reduction through significant reorganization we undertook in the second half of 2024, where we effectively cut burn substantially while we continued to invest in market development and work towards broad reimbursement and broad access. Turning to 2026 guidance, we expect our total Galleri revenue to grow at 22%-32% in 2026. We expect full year cash burn to be less than $300 million. Today's cash balance provides runway into 2030, and we are well positioned as we head into major milestones, including the readout of our registrational studies and a filing of our PMA. I'll now pass it over to Josh, who will review our differentiation and opportunity with Galleri.
Josh.
All right. Thank you. Really happy to be here today to join you and really talk through this amazing opportunity that sits right before us. As you know, cancer is the leading killer among adults over the age of 50 in the United States, soon to be the number one killer worldwide. And why is that? You've all been touched by cancer. We've all had losses to cancer, and it's because we're finding most cancers too late. Today, of the hundreds of deadly cancers that we know exist, we screen for five single cancers. And these tests detect only 14% of all the incident cancers that are out there. Yet 70%-80% of all the cancer deaths are from the cancers we're not looking for at all, that have no recommended screening.
GRAIL is dedicated to solving that problem, to identify cancers earlier when they can be treated more effectively and potentially cured. We simply have to move away from the model of looking at four or five individual cancers and also begin to look at an individual for whatever cancer you may develop. Because guess what? We don't get to choose the cancer that we get. Adding Galleri to single cancer screenings has the potential to fundamentally transform and improve the performance of our overall national screening program. Based on our study results, by adding Galleri to standard-of-care single cancer screening, we may be able to identify up to 60% of cancers through screening. That's a vast improvement over the 14% that we see today. Oh, thank you. Here are some of those statistics.
We envision a future where MCED testing is broadly available, provides an enormous public health impact, and will be delivered with a very strong economic value proposition to society and to payers. Galleri is setting the bar in multi-cancer early detection. We have the highest positive predictive value at 62%. We have the lowest false positive rate at 0.4%. We have very accurate prediction of where in the body the cancer signal is coming from, what we call the cancer signal origin or CSO, which enables efficient, targeted workups to get to diagnosis rapidly. When we launched, we had evidence that Galleri detected over 50 different types of cancer, which is remarkable. With our much larger clinical and commercial experience now, we've documented well over 100.
Critically, Galleri is the only MCED test that has published validation data in the intended use screening population, something I view as a prerequisite to be able to launch a commercial product and is conducting the largest evidence program ever undertaken for an MCED. We have developed three major pillars for our leadership in this whole space. The first is technology. We developed Galleri specifically to be a screening tool for cancer. In our discovery work, we looked at multiple genomic features, multiple technologies. We compared them head-to-head and in combination. We selected methylation-based technology based on its superior performance in the ability to not only detect cancer, but also predict where in the body that cancer comes from or a cancer signal origin. Now, the Galleri test works by identifying a cancer signal in abnormally methylated DNA fragments circulating in blood.
This is a signal that is identified by machine learning pattern recognition. It is a signal that is shared by many or most cancers. And importantly, it's a signal that is almost never seen in people without cancer. Because the test is based on circulating tumor DNA, it preferentially detects cancers that shed a lot of DNA into the blood. These are aggressive and invasive cancers, limiting the concerns related to the overdiagnosis of indolent forms of cancer that people are more likely to die with than to die from. And the vast data sets that we've accumulated through large-scale studies and our commercial experience provide a data flywheel effect for us that enables test improvements over time. Now, we've also focused on delivery.
As Bob mentioned, we invested in a state-of-the-art, highly automated CAP/CLIA lab in Research Triangle Park, North Carolina, with one million test capacity per year today and the ability to improve that substantially and expand it over time. We also have substantial fixed cost leverage, which will enable us to continue with price reductions over time. Now, we're pursuing FDA approval with our breakthrough device designation, and we have developed an evidence package to support our PMA that includes two large registrational trials. We've conducted extensive clinical validation in screening populations across numerous studies that have demonstrated consistent results, study after study after study. We've now been in the market for over four years. We've sold more than 475,000 commercial tests. Our experience and our engagement with the clinical community around MCEDs is simply unparalleled.
Now, when GRAIL was founded, we were focused on this big idea: how could we transform the entire paradigm about how we detect cancer, but there was also a focus on establishing a very high evidence bar for the field. After all, this is population-level screening, and we are in a very exciting time for data readouts. In October, we presented data from the first 25,000 participants in what is the largest U.S. MCED study, PATHFINDER 2 , at ESMO. Now, we demonstrated that when you add Galleri to U.S. USPSTF A and B-rated cancer screenings, it yielded a more than seven-fold, let me repeat that, seven-fold increase in the cancer detection rate in the population. When you add prostate cancer to those U.S. USPSTF screenings, we detected more than three-fold the number of cancers with the addition of Galleri.
Now, remarkably, more than half of the Galleri-detected cancers were found in early stages one and two. These cancers are localized when treatments are more effective and even curable. Nearly three-quarters of the cancers detected by Galleri have no recommended screening tests at all. The positive predictive value, one of the key clinical metrics, was nearly 62%. Now, remember, that's an order of magnitude higher than anything that is typically seen in single cancer screening tests, meaning positive test results are very trustworthy and highly actionable. The episode sensitivity for 12 deadly cancers that account for about two-thirds of deaths was almost 75%. Galleri's high signal-of-origin prediction accuracy helped physicians guide an efficient diagnostic workup. Importantly, there were no serious study-related adverse events. These data from PATHFINDER 2, along with the prevalence round of the NHS-Galleri trial, will be submitted to the FDA in Q1.
We have two additional study readouts coming out in 2026, including the full data set from the NHS-Galleri RCT and the complete 35,000-participant Pathfinder II study. These large data sets are completely unique in the field. They provide GRAIL with the deepest insights about early cancer detection, and they can help us improve our test over time. Taken together, this all demonstrates GRAIL's groundbreaking leadership of this emerging field. But we also know that to really achieve our aspiration of population-scale screening, we need to demonstrate clinical utility. And we're evaluating this in multiple trials. First, we saw a really important clinical utility measure in the Pathfinder II study that could have a major public health benefit. And I've mentioned this to you already: the ability to increase the cancer detection rate in the population through screening by seven-fold when Galleri was added to standard-of-care single cancer screening.
That's an important clinical utility measure. In the NHS-Galleri trial and in the Medicare REACH study, we are also assessing, as a clinical utility measure, the absolute reduction in the incidence of late-stage cancer. It's an incredibly exciting time for commercial growth at GRAIL. There's an enormous unmet need for cancer screening. There's a large addressable population, and we have best-in-class performance with Galleri. We're detecting cancers every single day. Our data readouts are generating palpable excitement with customers, generating physician and consumer confidence, and creating a lot of momentum for GRAIL. There are some strong near-term accelerants. We're continuing to expand the awareness of MCEDs. We have established significant differentiation. We are increasing our provider, patient, and employer conviction with Galleri, with the high-quality data readouts and the vast evidence program that we've undertaken. We anticipate an FDA approval.
If that's achieved, that will drive even greater clinical conviction and market adoption. We see continued integration into health systems. In fact, there are a number of high-profile health systems, like Mayo Clinic and Dana-Farber, that have recently published their own experience with Galleri and shown positive predictive values of 70%-80%. Those have been presented at major medical conferences. These systems are also incorporating Galleri into their workflows, and many of them are offering Galleri to their own employees, signaling their conviction in Galleri. Additionally, implementation of Galleri ordering and result delivery in electronic medical records, or EMRs, has a very positive impact on growth. It's not surprising when you make it easier for physicians to order. The breadth and depth of prescribing simply increases. Finally, as many of you are aware, there's a massive migration right now towards a more consumer-empowered healthcare market.
This is helping build a growing self-pay market. This is fueled in part by the growth of HSAs tied to high-deductible health plans and FSAs tied to employer offerings, which allow individuals to select preventive healthcare services and pay for them through those means, such as Galleri. GRAIL continues to make meaningful progress towards broad coverage and reimbursement, which is our aspiration for population-scale screening. We first set out to develop a world-leading evidence base to support a paradigm shift in cancer screening, operational capacity to support population-scale testing. Achieving FDA approval will serve as a major trigger for evidence-based coverage decisions with U.S. commercial payers, could enable Medicare coverage, and additionally support expansion in select regulated international markets. We've built out our lab infrastructure to enable substantial capacity. As discussed, we are progressing our clinical utility and cost-effectiveness evidence base to support coverage decisions among U.S.
Commercial payers and enable engagement with international single payer systems. We've made amazing progress over the last nine years, and we're looking forward to 2026 as a very exciting year. And these are the critical milestones. We're going to be completing our modular PMA submission in Q1. We'll be presenting our full data from the NHS randomized clinical trial in the middle of 2026 with a top-line announcement in advance. We're going to be presenting the full PATHFINDER 2 results of 35,000 participants in the middle of 2026. So it's going to be a very exciting year. I want to thank you all for joining us today, and we're happy to take some questions.
You mentioned that. I think they're going to—are you going to bring a microphone? Yeah. There are people online can hear.
You mentioned the price elasticity. So obviously, I've done the GRAIL test.
My wife's done it. It's $900. We paid it. We're not too happy about it. What's the thinking in that in terms of pricing and in terms of scaling up to get population scale?
Yeah, it's a good question. So we're in the early innings right now. So as we mentioned, we know there's price elasticity in the market. We've tested some of that in the various channels, and we do different volume discounting. Over the long term, though, like in the MCED space, we know the pricing is down towards $500. What we've really geared the business towards is that scale. We know that winning in this space is in the millions of tests. And so high-volume testing, which means we need to get our COGS down.
And so part of the automated system that I talked about and Josh talked about was really to drive the scalability and the COGS structure so that we see at the MCED bill pricing to be able to get to that 50%-60% margin at scale. So long term, we'll probably be driving towards that and also making sure our COGS structure is such that we can be in that range.
Good morning. Is there a pharma strategy? You have obviously produced a massive amount of data. Is there a pharma strategy for either an R&D or clinical development using this testing and clinical trials or anything like that? Yeah.
So right now, we do have biopharma partners who are using our tests for various things, both the data that we've generated as well as our test results, primarily in clinical studies, as a filter for who comes into the clinical study. So that's already happening. Thanks.
Good morning. Thanks for your presentation. Can you give examples of what specific cancers you're testing for?
Yeah. So most of the common cancers that you think of, lung, liver, gallbladder, pancreatic, those are all. So we're not looking for a specific cancer in the test. We're looking for a shared cancer signal. And so we expect to continue to find more cancers. As Josh mentioned, in the early days, we had seen 50 cancers. We've now seen over 100 different types of cancer. And we'll continue to see different types of cancer.
Hi. More on the NPV side, the negative predictive value.
Is there any progress or design where you could show and become substituting regular cancer screening in the future?
I'm sorry, PPV or?
NPV, negative predictive value.
Yeah. Joshua?
Yeah. So is your question talk more about the NPV? Yeah. Yeah. And could we replace single cancer screening? So it's really important two things. One, what Bob just said. Galleri was not designed to look for any particular cancer. We're not setting out to find these 12 or those 20 or those five. We are looking for this shared signal that is shared by many cancers. And that's very confusing for people about when we come to a mammogram looking for breast cancer or a colonoscopy looking for colon cancer. Our negative predictive value is about 99%. Okay? So none of these screening tests have perfect, we're going to miss cancers.
You saw that even our sensitivity for the group of cancers that account for two-thirds of deaths was about 75%. The negative predictive value is about 99%, which stacks up pretty well with many of the single cancer screenings. None of them are perfect. Galleri was designed to be a complement to the existing single cancer screenings, which have sensitivity that's very high for those single cancers, but they have very high false positive rates and very low positive predictive values. We will not replace colonoscopy. Colonoscopy finds precancerous polyps. They find precancer. We will not replace mammography, nor should we. We are a complement to those existing single cancer screening tests.
Anyone else? Oh, we got someone.
Just a follow-up question to the precancer signals. I think Natera just reported on improving their value in finding polyps and other precancer signals.
Would you b e also expanding Galleri to be able to look for other signals other than DNA cancer?
Yeah, go for it. I mean, you're asking a very interesting question. So what have we learned about blood-based cancer detection? Typically, it's very difficult to find precancerous lesions. There's questions about whether the blood-based colorectal cancer screening tests are even detecting adenomas, for example. What we do know is that in the heme space, the blood compartment, we have a very strong signal, and we do identify premalignant hematologic conditions. But it's highly unlikely that a blood-based test looking at ctDNA is going to be able to detect premalignant cancers from solid tumors or premalignancy in solid tumors. That's highly unlikely. And I think the question is still out about whether the blood-based colorectal cancer tests are actually detecting adenoma beyond what their false positive rate is. All right.
Thank you, everyone. Appreciate your attention.