GRAIL Q2 2025 Earnings Report

GRAIL EPS Results

• Actual EPS: -$3.18
• Consensus EPS: -$3.14
• Beat/Miss: Missed by -$0.04
• One Year Ago EPS: N/A

GRAIL Revenue Results

• Actual Revenue: $35.54 million
• Expected Revenue: $37.57 million
• Beat/Miss: Missed by -$2.02 million
• YoY Revenue Growth: N/A

GRAIL Announcement Details

• Quarter: Q2 2025
• Date: 8/12/2025
• Time: After Market Closes
• Conference Call Date: Tuesday, August 12, 2025
• Conference Call Time: 4:30PM ET

GRAIL (NASDAQ:GRAL) operates as a commercial-stage healthcare company, which engages in the development of a technology for early detection of cancer. It utilizes machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. The company was founded by Jeffrey T. Huber, William H. Rastetter, Mostafa Ronaghi, and Richard D. Klausner on September 11, 2015 and is headquartered in Menlo Park, CA.

GRAIL Q2 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: We observed substantially greater cancer detection and a higher positive predictive value in both the Pathfinder 2 and NHS-Galleri registrational studies, with specificity and signal origin accuracy consistent and no serious safety concerns reported.
• Positive Sentiment: Commercial momentum remains robust, with over 45,000 tests sold in Q2 and more than 370,000 prescriptions since launch, driving US revenues up 21% and repeat testing now over 25% of volume.
• Positive Sentiment: Financial performance improved as Q2 revenue rose to $35.5 million (+11% YoY), net loss narrowed by 93% to $114 million, and full-year cash burn guidance was lowered to ≤ $310 million, extending the cash runway into 2028.
• Negative Sentiment: Deployment of a new industrial scale automated testing platform led to increased turnaround times and higher sample reprocessing costs for a small proportion of samples, with remediation efforts now underway.
• Positive Sentiment: Strategic collaborations expanded access, including adding Rush University System for Health, launching direct prescription via EverlyWell, and integrating Galleri into Quest’s ordering platform, which accounted for 7% of Q2 orders.

Presentation

[Operator]

Good day, ladies and gentlemen, and welcome to the GRAIL Second Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.

[Alex Dobbin, Director at GRAIL]

Thanks, operator, and thanks, everyone, for joining us today. On the call are Bob Ragusa, our Chief Executive Officer Aaron Frieden, our Chief Financial Officer Doctor. Joshua Offin, our President Srirapu Kumar, our president, international business and biopharma and Andy Partridge, our chief commercial officer. We'll be making forward looking statements on this call based on current expectations. It's our intent that all statements other than statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward looking statements contained in Section 27A of the Securities Act of 1933 as amended and Section 21 of the Securities Exchange Act of 1934 as amended.

[Alex Dobbin, Director at GRAIL]

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 SEC, including the risk factor section in Grail's most recent quarterly report on Form 10 Q. This call will also include a discussion of GAAP results and certain non GAAP financial measures, including adjusted gross profit or loss, which are adjusted to exclude certain specified items.

[Alex Dobbin, Director at GRAIL]

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 posted to our website. And with that, we turn to Bob.

[Bob Ragusa, CEO & Board Member at GRAIL]

Thank you. Good afternoon, everyone, and thank you for joining us to review second quarter results. For nearly a decade, GRAIL has made key investments to advance our vision for population scale, multi cancer early detection, and establish a durable advantage in a growing field. The time frame to establish evidence in this space is long, and we are setting the evidence bar high. We started population scale clinical studies years ago and now have several years of follow-up data.

[Bob Ragusa, CEO & Board Member at GRAIL]

Our pivotal implementation and clinical utility studies in the intended use population are beginning to read out, and we are delighted to see results not only confirm earlier studies, but actually improve certain performance measures as we evaluate gallery in larger populations. We plan to submit detailed results from the prespecified analysis of the first 25,000 patients in our registrational pathfinder two study for presentation at the ESMO Congress twenty twenty five in October. As a reminder, we announced positive top line performance and safety results from this dataset in June, namely that we observed substantially greater additional cancer detection and a substantially higher positive predictive value in Pathfinder two compared to the first Pathfinder study. And Josh will describe these results further shortly. We have been working with advocates and stakeholders to deploy an mSAID, and we are finding aggressive cancers in real world commercial setting, many of which are in early stages.

[Bob Ragusa, CEO & Board Member at GRAIL]

Gallery test orders continue to grow at a strong clip with more than 45,000 gallery commercial tests sold in the second quarter. As of June 30, more than 370,000 gallery tests have been prescribed by more than 15,000 health care providers since we launched Gallery commercially in 2021. We continue to drive provider and patient awareness of the MCET opportunity and Gallery's ability to detect cancer earlier when it is more amenable to treatment. GRAIL has established several partnership with health care systems to make Galleri available to patients, and we were very pleased to add Rush University System for Health in July. Rush is one of the largest health systems in The US and the first in the Chicago area market to offer the Galleri test.

[Bob Ragusa, CEO & Board Member at GRAIL]

Additionally, we recently entered into a new collaboration with EverlyWell, a digital health company pioneering in next generation of biomarker intelligence, and Gallery is now available for request directly on Everly Wells' website via prescription. We remain on track for continued commercial growth in 2025. We are also encouraged by increasing Gallery volume via the Quest diagnostic test ordering platform at midyear, which follows gallery integration into the platform earlier in 2025. In late twenty twenty four, we began the use of a new version of gallery for which we are submitting our PMA in commercial channels. This new version incorporates an industrial scale platform with significant automation intended to enable us to scale more efficiently with future demand.

[Bob Ragusa, CEO & Board Member at GRAIL]

As a result of the scale and complexity of the system, there are certain new processes to sort through with a large scale rollout. For example, for a small proportion of samples, we've experienced increased turnaround times with higher reprocessing costs. We are now working to implement the fix to this issue. Before I hand it over to Josh, I'd like to notify the group that we will host our twenty twenty five analyst day in November. Featured speeches will detail key study results and clinical surveillance findings, frame our upcoming longitudinal clinical utility data, and describe firsthand customer experience with Gallery.

[Bob Ragusa, CEO & Board Member at GRAIL]

Event details will be announced at a later date. Josh, please go ahead.

[Joshua Ofman, President at GRAIL]

Thanks, Bob, and hello, everyone. We've spoken in the past about key performance metrics, features, and capabilities for multi cancer early detection tests, which are quite different from those for single cancer screenings. Most critically, any test developer must confirm clinical validation in the intended use population of asymptomatic adults eligible for screening before they introduce those tests into clinical practice. This critical criterion was the reason that Grail did not introduce Gallery into clinical practice until we saw the results from the Pathfinder trial in the screening population. Even tests with strong results in observational case controlled studies may fail to confirm those results in the actual screening population.

[Joshua Ofman, President at GRAIL]

Full clinical validation requires demonstration of compelling performance in the intended use population. It is simply not possible to know the benefits and potential harms of any test before being adequately studied in the intended use population. It is also important to note that any multi cancer test seeking FDA approval will need to demonstrate this as well. So in terms of performance metrics, we've discussed what we consider to be most clinically important for NSAIDs, positive predictive value or PPV, which tells us among positive test results how many cancers are found or how many are actually true positives. And the specificity, critically important, which defines the false positive rate, as well as the cancer detection yield when added to standard of care screening and the ability to localize where in the body a cancer signal is coming from.

[Joshua Ofman, President at GRAIL]

After hundreds of thousands of commercial tests performed, we've now confirmed how essential it is for any MSAID test to report a predicted CSO or cancer signal origin to guide an efficient and effective clinical workup. We believe that any other approach such as relying on whole body imaging with its radiation exposure, cost, and lack of any performance or safety data is simply not practicable. Our first clinical implementation study, Pathfinder, which was presented at ESMO in 2022, showed that Gallery more than doubled the number of cancers identified when added to standard of care screening. About half of the m said detected cancers were at early stage, and about seventy percent of the mSAID detected cancers had no recommended screenings at all. The positive predictive value for Gallery in the study population was forty three percent, which as you recall is an order of magnitude higher than leading single cancer screening tests whose PPVs remain in the single digits.

[Joshua Ofman, President at GRAIL]

Gallery specificity was ninety nine point five percent, and its cancer signal of origin accuracy was eighty eight percent. We have subsequently undertaken Pathfinder two, similarly designed as a prospective multicenter interventional study of Gallery added to standard of care screening designed to assess the performance and safety of Gallery in an even larger and more representative intended use population. As Bob said, we observed a number of very promising results in the prespecified analysis of the first 25,000 participants enrolled with twelve months follow-up and shared top line results in June. First, adding Gallery to standard of care screening in Pathfinder two demonstrated substantially greater additional cancer detection than that observed in the first Pathfinder study. That is substantially greater than the more than doubling of the overall number of cancers detected when added to standard of care in the first Pathfinder study.

[Joshua Ofman, President at GRAIL]

Second, data showed a substantially higher positive predictive value than that observed in the first Pathfinder study, which was forty three percent. Third, specificity and CSO accuracy were consistent with that observed in the first PATHFINDER study. And finally, there were no serious safety concerns reported in PATHFINDER two. We're enormously pleased with the top line results from both of our registrational studies, PATHFINDER two and the NHS gallery randomized clinical trial. You will recall in May that we completed a review of gallery test performance results in the intervention arm from the prevalence screening round of the registrational NHS gallery trial.

[Joshua Ofman, President at GRAIL]

Data from the prevalence screening round showed a substantially higher positive predictive value than that observed in the first PATHFINDER study. Specificity and CSO accuracy were consistent with that observed in the first PATHFINDER study. And again, there were no serious safety concerns observed in Pathfinder two, also consistent with the first Pathfinder study. These top line findings from NHS gallery and Pathfinder two confirm and extend what we already know about our multi cancer early detection technology. The technology has been validated through many robust studies, including intended use populations and through hundreds of thousands of commercial and clinical study test results showing very consistent results.

[Joshua Ofman, President at GRAIL]

Data presented at the ASCO annual meeting twenty twenty five in May included a five year follow-up analysis of the circulating cell free genome ATLAS study, which demonstrated Gallery's preferential detection of aggressive and clinically meaningful cancers. These findings were consistent with earlier analyses assessing the prognostic importance of Gallery's cell free DNA based methylation approach. Between case controlled studies and prospective implementation studies in the intended use population, we have not seen deterioration in the key performance metrics. Many of you will know this is not always the case. Case control performance often doesn't carry over into the real world, But we saw no deterioration in specificity, positive predictive value, or cancer detection yield.

[Joshua Ofman, President at GRAIL]

And now we're moving into readouts of much larger registrational studies in the intended use groups, as well as analyses performed by large health systems who have actual clinical experience with Gallery. And we're seeing a body of results with substantially improved PPV figures and substantially higher cancer detection numbers, while other key figures like specificity and CSO accuracy remain consistent. Earlier in GRAIL's development phase of our ENSET technology, we deployed a very rigorous, unbiased, and comprehensive discovery approach to identify the effective genomic features for early cancer screening. Out of those approaches evaluated, methylation patterns exhibited the strongest performance for both sensitive and specific cancer signal detection and accurate prediction of the cancer signal origin. Adding on other analytes or DNA features did not improve the performance.

[Joshua Ofman, President at GRAIL]

What we are seeing today from our growing dataset strengthens our conviction in our targeted methylation approach, which is focused on highly informative and low noise methylation regions known to be informative for cancer. Through hundreds of thousands of samples run-in both clinical studies and commercially, we're seeing very strong positive predictive values and cancer detection rates and a highly accurate cancer signal of origin prediction, all of which critically is achieved at a very low false positive rate of point five percent, which befits population scale testing. Remember, if another test developer is operating at a lower specificity, a difference in specificity of 99.5% to ninety eight point five percent is actually a three times higher false positive rate. That's really important to remember. We reported top line results from PATHFINDER two in order to preserve detailed results for a major medical meeting, And we hope to present the full data set at ESMO in October.

[Joshua Ofman, President at GRAIL]

We look forward to discussing detailed results from PATHFINDER two with you potentially very soon. I'll now hand off to Aaron for a review of the financials.

[Aaron Freidin, CFO at GRAIL]

Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the second quarter. Overall, second quarter results were strong. Revenue for the quarter was $35,500,000 up $3,500,000 or 11% as compared to the 2024. Total revenue for the quarter is comprised of $34,400,000 of screening revenue and $1,100,000 of development services revenue.

[Aaron Freidin, CFO at GRAIL]

Development service revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development. We see continued demand for our Gallery test and sold more than 45,000 tests in the second quarter. We have historically observed seasonal fluctuations over the course of the year, in particular, relatively high volume in the second and fourth quarters and lower in the first and third, and we would expect these seasonal trends to continue. Repeat test volumes have trended higher over time, including year to date. Today, more than 25% of Galleries' volume is repeat testing.

[Aaron Freidin, CFO at GRAIL]

Spending revenue of $34,400,000 in the second quarter was up 22 as compared with the 2024. U. S. Gallery revenue was $34,200,000 up 21% compared to the second quarter last year. The second quarter has been a strong quarter for U.

[Aaron Freidin, CFO at GRAIL]

S. Gallery revenue historically. We are on track relative to our full year guidance of U. S. Gallery revenue growth between 20% to 30%.

[Aaron Freidin, CFO at GRAIL]

As stated last quarter, we do not expect major impacts from tariffs on our current business as our laboratory is located in The U. S. And a significant majority of our suppliers are located in The And manufacture in The U. S. Cost of screening revenue, exclusive of amortization of intangible assets as a percent of revenue, decreased in the 2025 compared to the same period in 2024, primarily due to a six percent decrease in ASP and additional sample reprocessing costs, partially offset by the reduction in variable costs of gallery testing performed on our automated platform.

[Aaron Freidin, CFO at GRAIL]

Net loss for the quarter was $114,000,000 an improvement of 93% as compared to the 2024. Net loss in the second quarter includes impairment of Illumina acquisition related intangible assets of $28,000,000 and stock based compensation of $14,200,000 While we focus on advancing Gallery, we remain committed to our ongoing work with pharma partners, and we have confidence in the potential application of our technology. Non GAAP adjusted gross profit for the 2025 was $16,100,000, an increase of $100,000 or 1% as compared with the 2024. We ended the quarter with a cash position of $606,100,000 In January, we guided that we expect cash burn for the full year 2025 to be no more than $320,000,000 And we are updating the guidance to cash burn of no more than $310,000,000 for the full year of 2025, which represents a decrease of more than 40% to 2024. Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones. I'll turn it back to Bob for concluding remarks.

[Bob Ragusa, CEO & Board Member at GRAIL]

Thank you, Aaron. To close, we are highly encouraged by the demand we are seeing today both for new patients and for returning patients who are repeat testing. Our strategic priorities are seeking FDA approval of Gallery and pursuing broad reimbursement. We are advancing Gallery today toward near term key clinical and regulatory catalyst to achieve broad access while maintaining our disciplined cost management. We plan to submit for presentation at ESMO in October detailed performance and safety results from the first 25,000 participants enrolled in the Pathfinder two study.

[Bob Ragusa, CEO & Board Member at GRAIL]

This is a registrational dataset that will go to the FDA. Soon into 2026, our key milestones are the completion of our modular PMA submission to the FDA in the first half and full clinical utility results from our 140,000 participant NHS Gallery study, which we expect to read out midyear. This longitudinal data set will be reviewed by the NHS to determine Gallery's potential deployment within The UK population. As I mentioned earlier, we look forward to seeing many of you at our twenty twenty five Analyst Day in November. With that, we'll turn the call over to q and a. Operator, please go ahead.

[Operator]

Thank you. At this time, if you would like to ask a question, please click on the raise hand button, which can be found on the black bar at the bottom of your screen. You may remove yourself from the queue at any time by lowering your hand. When it is your turn, you will hear your name called and receive a prompt to unmute. Our first question will come from Kyle Mixon with Canaccord Genuity. Your line is open. Please ask your question.

[Alex Vukasin, VP Healthcare Equity Research Analyst at Canaccord Genuity - Global Capital Markets]

Hi. This is Alex on for Kyle Mixon. Thanks for taking my questions. Let me just take a step back here. So the first quarter cash burn came a bit higher than we expected.

[Alex Vukasin, VP Healthcare Equity Research Analyst at Canaccord Genuity - Global Capital Markets]

That's partially due the bonuses that you have payout in the prior year period in one q, but that's obviously not our paid in future quarters. You modestly improved the burn target for 2025. Can you just comment on two q free cash burn? And then just given how integral the burn is to your story, can you elaborate on any other other dynamics that could impact cash burn into in second half twenty five? Would that be additional r and d, increases the headcount, or any other one offs? Thanks.

[Bob Ragusa, CEO & Board Member at GRAIL]

Yeah. Aaron, you want Aaron, you wanna take that one?

[Aaron Freidin, CFO at GRAIL]

Yeah. Happy to. Yeah. Thanks for the question. So I think we've first six months, it was about a $160,000,000 of burn, you know, and and it is important for us to, again, as Bob said, manage the business, you know, as as efficiently as possible.

[Aaron Freidin, CFO at GRAIL]

We we do see that coming down in the next couple quarters as you can, you know, get into the $310,000,000 no more than guide that we just updated, you know, really driven by, you know you know, increased, you know, volumes in the in the back half of the year, increased revenue. And, also, you know, we we'll be working on working through some of the getting more volume on our our our new automated platform.

[Bob Ragusa, CEO & Board Member at GRAIL]

Yeah. I'd like maybe just add a little color to that too. You know, one of the things when we did the restructuring, we wanted to make sure that we gave ourselves a lot of flexibility in the go forward state and, you know, recognizing that, you know, MCED being a new field, we, you know, undoubtedly face a number number of new new and interesting challenges. So, you know, that flexibility is a key element. And I think, you know, by doing the restructuring, getting us cash into 2028 has has provided that.

[Bob Ragusa, CEO & Board Member at GRAIL]

And I think, you know, being able to guide down a little to three ten shows, you know, we're you know, we we think we're on track to be able to to hit that more aggressive number.

[Alex Vukasin, VP Healthcare Equity Research Analyst at Canaccord Genuity - Global Capital Markets]

Got it. Thank you for the color.

[Operator]

Our next question will come from Subbu Nabi with Guggenheim. Your line is open. Please ask your question.

[Subbu Nambi, MD - Senior Analyst at Guggenheim Securities]

Hey, guys. Thank you for taking my question. Just to clarify, do you not need full longitudinal clinical utility data that is mid twenty twenty six for PMA submission? One. And then when you say significantly higher PPV in pathfinder two, I had a basic question.

[Subbu Nambi, MD - Senior Analyst at Guggenheim Securities]

Are you normalizing for cancer prevalence in both these studies? Just because shouldn't cancer prevalence impact PPV?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yeah. Maybe yes. I'll start off. Thanks for the questions. So, you know, on the clinical utility question, question, so, you know, the FDA, if you go back to their their advisory board meeting, they're really gonna be looking at, you know, benefits benefits harms view of the world.

[Bob Ragusa, CEO & Board Member at GRAIL]

And so they they are not gonna be looking looking at clinical utility and typically don't for for the approvals. That gets more much more into the payer discussion. You know? So the payers would more typically look at that, but that and that's what the NHS gallery data will provide. Josh, do you maybe wanna take the PPV question on Pathfinder two?

[Joshua Ofman, President at GRAIL]

Sure. So, you know, again, on the on the FDA, they're gonna be focused on clinical validation rather than clinical validity utility, excuse me, clinical validation, not clinical utility, and they will and they've said that in their in their own advisory board, as Bob said. On the PPV, you know, right now, we are not normalizing that for the standard population. We're reporting it out within each study's population. As we mentioned earlier, these are much broader, more diverse, and more representative populations than has been studied previously.

[Joshua Ofman, President at GRAIL]

And so we're expecting that, you know, there will be a more diverse cancer risk in that population and cancer incidents, which may be driving the higher PPV. And so we will ultimately normalize all of this for cancer incidents and the cancer case mix, which is the distribution of cancers within each population, which is enormously important for performance reporting. We will ultimately do that, but today, we're just reporting them within the study population themselves.

[Subbu Nambi, MD - Senior Analyst at Guggenheim Securities]

Thank you so much for clarifying that. And then one follow-up. Non sequitur, based on other prior integrations with more concierge type testing platforms like Function and Superpower, how long is the typical growth ramp, and do you expect EarlyWell to drive similar volumes?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yeah. So we, you know, we have seen, you know, good consistent performance out of, you know, groups like Function and, you know, been very good partners. We we anticipate that Nevely will will add, you know, add an important dimension to the channel with, you know, a whole another outlet given their subscriber base. Maybe, Andy, do you wanna Andy Parkster, c c CCO, you wanna add some color to that?

[Andy Partridge, Chief Commercial Officer at GRAIL]

Yeah. Absolutely. So, yeah, we're definitely anticipating these telemedicine longevity based platforms like Function Health, like EverlyWell to really give us a tailwind in terms of growth. Going forward, when we look at EverlyWell, they've had millions of customers order through their platform, and Eveliwell in terms of the Eveli three sixty launch that they announced, offering Gallery as an add on, and they've emailed hundreds of thousands of their customers about the Gallery multi cancer early detection test. So we're excited to partner with groups like Function Health, like EverlyWell, as they really amplify our education around Gallery and multi cancer early detection.

[Subbu Nambi, MD - Senior Analyst at Guggenheim Securities]

Perfect. Thank you, guys.

[Operator]

Our next question will come from Yuko Oku with Morgan Stanley. Your line is open. Please ask your question. Yuko Oku with Morgan Stanley, your line is open. Please ask your question.

[Yuko Oku, Equity Research Associate at Morgan Stanley]

Hello. Thank you for taking my questions. With time timelines for PMA submission approaching, could you elaborate on customer support infrastructure in place to help integrate MSAID testing in cancer care today? And then outside of sales reps, what are areas you tend intend to bolster as you get closer to the timing of anticipated FDA approval?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yeah. So the timeline, you know, timeline for our PMA submission is 2026. You know, we're anticipating, you know, beyond that for FDA approval, about a one year process since we believe since this is the first MCED that will go through the FDA, we believe it'll be about a one year process due to having an advisory board. So that puts you out into, you know, kinda mid, you know, first half first half twenty twenty seven. And, you know, with that, we've been consistently ramping our customer support, you know, both size as well as capability in line with, you know, in line with the growth of the business.

[Bob Ragusa, CEO & Board Member at GRAIL]

So, you know, we would, you know, we would assume that we would continue to do that. We're obviously looking for efficiencies in the way we deliver that customer support going through that process. In terms of other elements, you know, we at that point, we'll be looking at, you know, from a you know, certainly from a sales and marketing perspective, how much effort we're gonna be putting in as well. And, also, looking at, you know, from a cost perspective, you know, we expect some step downs in cost in other areas of the business as we get through those important milestones. Andy, anything you wanna add on the customer support side?

[Andy Partridge, Chief Commercial Officer at GRAIL]

Yeah. I think you covered it, Bob. We're we're really looking at what are those opportunities to expand our customer facing teams. We're gonna do that to capture those growth opportunities. We're also gonna continue to keep an eye on expenses as you outlined, Bob, as we really wanna drive to kind of a commercial breakeven, kind of going forward. So

[Yuko Oku, Equity Research Associate at Morgan Stanley]

Great. Thank you for that color. And if I could squeeze one more in, if I may. Could you elaborate on the statistical powering of the NHS gallery study? What difference is the trial power to detect on the primary endpoint of reduction in the incidence of late stage cancers versus the control arm? And what result will be viewed as meaningful benefit?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yeah. Harpal, you maybe wanna take that one?

[Harpal Kumar, President - International Business & BioPharma at GRAIL]

Yeah. Sure. So, I mean, the the the stout the study is powered to show a significant reduction in late stage cancer. So we the primary endpoint is is is a reduction in stage three and four cancers, and we look first at the 12 cancers that represent about two thirds of all cancer mortality, and then we go on to look at all cancers from there. So, you know, we will be looking at that late stage reduction.

[Harpal Kumar, President - International Business & BioPharma at GRAIL]

We don't have a specific reduction in mind, but it's but the size of the study was set to be able to deliver a statistically significant result in terms of that reduction. So we will see, you know, we will see what that reduction ends up being. We're interested, obviously, both in reduction of stage three and four cancers, but also stage four cancers because, you know, ultimately, people primarily die of stage four cancers. So if we can see significant reductions in those late stage cancers, we believe this will provide substantial benefit to the population.

[Operator]

Our next question will come from Doug Schenkel with Wolfe Research. Your line is open. Please ask your question.

[Colleen Babington, Equity Research Associate at Wolfe Research LLC]

Hi. This is Colleen on for Doug. Thanks for taking our question. As the NHS data reads out next year, we think that could serve as a strong evidence package for other international opportunities with single payer systems. How are your conversations with territories across the globe looking to deploy Gallery?

[Colleen Babington, Equity Research Associate at Wolfe Research LLC]

Also, if international volume grows sufficiently, will you have to do a tech transfer to international labs?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yes. No. That's a great question. So, you know, we get a tremendous amount of inbound interest, as you can imagine, from from around the globe. And with that, we've had, you know, numerous conversations.

[Bob Ragusa, CEO & Board Member at GRAIL]

You know, we also believe, as you rightly point out, that in middle of next year from, you know, from an efficiency standpoint, effectiveness standpoint, the middle of next year when we read out the NHS gallery study, we think that's gonna be a great calling card to really have, you know, significant discussions with a lot of countries around the globe, both due to just the sheer size of the study, but also the rigor and reputation of studies done on the NHS. I think that reputational advantage will go a long way as we have those conversations. Now, Harpaul, anything you wanna add with that?

[Harpal Kumar, President - International Business & BioPharma at GRAIL]

I think you've largely covered it, Bob. I mean, as as you said, you know, this is a very large study conducted extremely well in a in a health system that is very well respected around the world. So we fully expect that the results from this study will be and are being observed by countries right across the world. We're getting, as Bob said, a lot of inbound interest from, you know, pretty much every country around the world, and we we expect that the results, you know, middle of next year will provide us with the data to really turn those conversations into meaningful opportunities as we look forward. And as you alluded to, should give us a a substantial growth opportunity as we look forward.

[Colleen Babington, Equity Research Associate at Wolfe Research LLC]

Thank you.

[Operator]

Our last question will come from David Westenberg with Piper Sandler. Your line is open. Please ask your question. David Westenberg with Piper Sandler, your line is open. Please ask your question.

[Operator]

I'm not sure if David is having audio issues. Can you hear us, David?

[Jon Petersen, MD & Head - US REIT Team at Jefferies]

Hi. This is John on for Dave. Can you hear me?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yes. Hi.

[Jon Petersen, MD & Head - US REIT Team at Jefferies]

This is John on for Dave. Can you, can you hear me?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yes. We can.

[Jon Petersen, MD & Head - US REIT Team at Jefferies]

Great. Thank you. So just first off, Quest integrated gallery into their ordering system earlier this year. It's still early days, but could you just give any color on what you're seeing in terms of orders coming through the Quest platform at this point? And, any thoughts on what's driving it?

[Bob Ragusa, CEO & Board Member at GRAIL]

Yeah. So maybe, answer in reverse. You know? So part of integrating with Quest is we've what we found is every time you remove friction from the system, we see an uplift in uplift in sales. And so, you know, we believe that Quest with their know, you and the Quest integration will be able to give that significance, you know, kind of friction reduction in the system.

[Bob Ragusa, CEO & Board Member at GRAIL]

What we've seen so far year to date is about 500 health health care professionals have ordered the gallery test via the Quest system. And in q two, we saw about 7% of the orders actually came through the Quest platform. And so we're we're pretty excited about, you know, the, you know, the uptake on Quest being, you know, relatively quick. And, you know, as we try to onboard more more practitioners, you know, some of them can just go in immediately in order to gallery tests on their Quest integration, while others need to specifically enable the gallery tests. You know, know, that enablement typically takes a few weeks to occur, and so we do anticipate that we'll continue to grow grow that channel.

[Bob Ragusa, CEO & Board Member at GRAIL]

And then another, you know, nice part about it is what we're finding is the Quest the Quest providers, people going through that system tend to, you know, be higher prescribers. And so, you know, we look at the ordering depth by prescriber, and they send tend to be some of the higher ones. So we're seeing that get enabled, definitely drives increased volumes.

[Jon Petersen, MD & Head - US REIT Team at Jefferies]

Great. Thank you. And, just a little more broadly, could you give any color on, how do you interpret the repeat test rate for Gallery? Are you pleased with it? Do you have a a target, in mind?

[Jon Petersen, MD & Head - US REIT Team at Jefferies]

And, just any general thoughts on the directional trend for repeat testing.

[Bob Ragusa, CEO & Board Member at GRAIL]

Sure. So, you know, first, we're we're pretty pleased with repeat testing. You know, last quarter, we were at, you know, over 20%. This quarter, we went to 25. We've seen a continuous step up in repeat testing, which I think is really a testament to the both the product as well as the medium.

[Bob Ragusa, CEO & Board Member at GRAIL]

You know, we think, you know, a blood blood based test has you know, is gonna have, you know, a better adoption capability than some of the other, you know, medias. And, you know, we also think the fact, you know, that it compares very favorably to other tests given that it's not a you know, a nonreimbursed test generally to have, you know, repeat test rates above twenty five percent at this stage of the game is is something we're pretty happy with, and it's also something we're looking to, you know, continue to do efforts to make sure we continue to drive that higher.

[Jon Petersen, MD & Head - US REIT Team at Jefferies]

Great. Thank you.

[Operator]

Thank you. There are no further questions at this time. I will now turn the call back to Grail for closing remarks.

[Bob Ragusa, CEO & Board Member at GRAIL]

I just wanna thank everybody for the questions, and I look forward to talking to at the next call.

[Operator]

Ladies and gentlemen, this concludes the call. You may now disconnect.

Participants

Executives

• Alex Dobbin, Director
• Bob Ragusa, CEO & Board Member
• Joshua Ofman, President
• Aaron Freidin, CFO
• Andy Partridge, Chief Commercial Officer
• Harpal Kumar, President - International Business & BioPharma

Analysts

• Alex Vukasin, VP Healthcare Equity Research Analyst at Canaccord Genuity - Global Capital Markets
• Subbu Nambi, MD - Senior Analyst at Guggenheim Securities
• Yuko Oku, Equity Research Associate at Morgan Stanley
• Colleen Babington, Equity Research Associate at Wolfe Research LLC
• Jon Petersen, MD & Head - US REIT Team at Jefferies