Q1 2025 GRAIL Inc Earnings Call

May 13, 2025

<unk> there will be a question and answer session.

Unknown Executive: After the speaker's presentation, there will be a question and answer session.

Speaker Change: Please be advised that this conference call is being recorded Grail Investor Relations. Please begin.

Yeah.

Unknown Executive: Please be advised that this conference call is being recorded.

Unknown Executive: Grail Investor Relations, please begin. Thanks, Operator. And thanks, everyone, for joining us today.

Bob Grills: Thanks, operator, and thanks, everyone for joining us today on today's call are Bob producer Grills, Chief Executive Officer, Darren Freedom, Chief Financial Officer, Dr. Joshua Hoffman President <unk>.

Unknown Executive: On today's call are Bob Ragusa, Grail's Chief Executive Officer, Aaron Freidin, Chief Financial Officer, Dr. Joshua Ofman, President, Sir Harpal Kumar, President, International Business and Biopharma, and Andy Partridge, 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.

Kumar: Sure Helpful Kumar, President International business, and Biopharma, and Andy Partridge, Chief Commercial officer.

Kumar: We will be making forward looking statements on this call based on current expectations. It is our intent that all statements other than statements of historical fact made during todays 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 27, a of the Securities Act of 933 as amended.

Kumar: And section 21 of the Securities Exchange Act of 1934 as amended.

Kumar: 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 <unk> assumes no obligation to update these statements.

Unknown Executive: 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 documents that Grail files with the SEC, including the Risk Factor section in Grail's most recent quarterly report on Form 10-Q.

Kumar: 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 factors section in <unk>. Most recent quarterly report on Form 10-Q.

Kumar: 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.

Unknown Executive: This call will also include a discussion of gap results and certain non-gap financial measures, including adjusted gross profit or loss, which are adjusted to exclude certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of Grail's financial needs. Reconciliations of Non-Gap Measures to Most Directly Comparable Gap Financial Measures are available in the press release issued today, which is posted to our website.

Kumar: Our non-GAAP financial measures are intended to supplement your understanding of Grilles financials <unk>.

Kumar: Reconciliations of 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.

Operator: Good day, ladies and gentlemen, and welcome to the Grail First Quarter 2025 Earnings Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session.

Speaker Change: Good day, ladies and gentlemen, and welcome to the Grail First Quarter 2025 earnings call. At this time, all participants are in listen-only mode.

Bob Ragusa: And with that, we turn to Bob. Thank you.

Bob Grills: Thank you good afternoon, everyone and thank you for joining us to review first quarter results.

Bob Ragusa: Good afternoon, everyone, and thank you for joining us to review first quarter results. We're making progress toward our vision of population scale, multi-cancer early detection, and our main focus on developing the market.

Bob Grills: We're making progress toward our vision of population scale multi cancer early detection and remain focused on developing the market.

Speaker Change: After the speaker's presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. Grail Investor Relations, please begin.

Operator: Please be advised that this conference call is being recorded. Grail Investor Relations, please begin.

Bob Grills: We plan to continue advancing gallery through several key clinical and regulatory milestones that will help unlock broad access while maintaining our disciplined cost management.

Bob Ragusa: We plan to continue advancing Gallery through several key clinical and regulatory milestones that will help unlock broad access while maintaining our discipline cost management.

Aaron Freidin: Thanks, Operator. And thanks, everyone, for joining us today.

Speaker Change: Thanks operator and thanks everyone for joining us today. On today's caller, Bob Ragusa, Grail's Chief Executive Officer, Aaron Freidin, Chief Financial Officer, Dr. Joshua Ofman, President.

Aaron Freidin: On today's call are Bob Ragusa, Grail's Chief Executive Officer, Aaron Freidin, Chief Financial Officer, Dr. Joshua Ofman, President, Sir Harpal Kumar, President, International Business and BioPharma, and Andy Partridge, 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.

Bob Grills: We are very pleased this afternoon to share positive topline results from the prevalent round of screening in the 140000 participants NHS Gallery trial.

Bob Ragusa: We are very pleased this afternoon to share positive top-line results from the prevalent round of screening in the 140,000-participant NHS Gallery trial.

Speaker Change: Sir Huffle Kumar, President, International Business and Bound Forber, and Andy Partridge, Chief Commercial Officer.

Bob Grills: NHS Gallery is one of our two Registrational studies and as Harpo will describe shortly these results continued to demonstrate strong gallery performance in detecting multiple types of cancers with very low false positive rates.

Harpal Kumar: NHS Gallery is one of our two registrational studies, and as Harpal will describe shortly, these results continue to demonstrate strong gallery performance in detecting multiple types of cancers with very low false positive rates.

Speaker Change: We'll be making forward-looking statements on this call based on current expectations.

Speaker Change: 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 in commercial activity.

Speaker Change: I'll take a moment to review key achievements in the first quarter before turning it over to Harp Hall.

Speaker Change: We'll be covered by the safe harbor provisions for four looking statements contained in Section 27A of the Securities Act in 1933 as amended in Section 21 of the Securities Exchange Act of 1934 as amended.

Bob Ragusa: I'll take a moment to review key achievements in the first quarter before turning it over to Harpal, then Josh will provide a medical and scientific update, and Aaron will cover the financial. We are building on our unique position as the first mover in the multi-cancer early detection field with the only commercially available, clinically validated, and said test that has shown the ability to detect many types of cancer. Grail has sold more than 37,000 gallery tests in the first quarter, and as of March 31st, more than 325,000 gallery tests have been prescribed by more than 14,000 health care providers since we launched gallery commercially in 2021.

Speaker Change: And then Josh will provide a medical and scientific update and Aaron who will cover the financials.

Speaker Change: We are building on our unique position as the first mover in the multi cancer early detection field with the only commercially available clinically validated <unk> test that has shown the ability to detect many types of cancer <unk> hundred 37000 Gallery tests in the first quarter and as of March 31 more than 300.

Aaron Freidin: 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.

Speaker Change: To better understand the risks and uncertainties that could cause actual results to differ, we refer you to documents that GRAIL files with the SEC, including the risk factor section in GRAIL's most recent quarterly report on Form 10-Q.

Speaker Change: 25000 gallery tests have been prescribed by more than 14000 health care providers since we launched gallery commercially in 2021.

Speaker Change: We continue to derive provider and patient awareness of the <unk> opportunity and galleries ability to detect cancer early when it is more amenable to treatment and importantly, we are generating real world evidence.

Aaron Freidin: This call will also include a discussion of gap results and certain non-gap financial measures, including adjusted gross profit or loss, which are adjusted to exclude certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of Grail's financial. Reconciliations of Non-Gap Measures to Most Directly Comparable Gap Financial Measures are available in the press release issued today, which is posted to our website.

Bob Ragusa: We continue to drive provider and patient awareness of the MSAID opportunity and Galleries' ability to detect cancer early when it is more amenable to treatment. And importantly, we are generating real-world evidence. as our leading health systems and physician practices who have offered MSED as early gallery adopters. We are proud of the demonstrated impact gallery is having on patients lives today, and I'm excited about our technology potential to affect how and when we find cancer on broad scale. We've made significant investments over time to optimize our technology and laboratory infrastructure. And we began the rollout of an enhanced version of the gallery test in the fourth quarter of last year.

Speaker Change: Our non-GAAP financial measures are intended to supplement your understanding of Grail's financials.

Speaker Change: As our leading health systems and physician practices, who have offered and said as early gallery adopters.

Speaker Change: Reconciliation of the Non-Gat Measures to most directly comparable Gat Financial Measures are available in the press release issue today which is posted to our website and with that we turn to Bob.

Speaker Change: We're proud of the demonstrated impact gallery is having on patients' lives today and I am excited about our technology has potential to affect how and when we find cancer on broad scale.

Bob Ragusa: And with that, we turn to Bob. Thank you. Good afternoon, everyone, and thank you for joining us to review first quarter results. We're making progress toward our vision of population scale, multi-cancer early detection, and our main focus on developing the market. We plan to continue advancing Gallery through several key clinical and regulatory milestones that will help unlock broad access while maintaining our discipline cost management. We are very pleased this afternoon to share positive top-line results from the prevalent round of screening in the 140,000-participant NHS Gallery trial. NHS Gallery is one of our two registrational studies, and as Harpo will describe shortly, these results continue to demonstrate strong gallery performance in detecting multiple types of cancers with very low false positive rates.

Bob Ragusa: Thank you. Good afternoon, everyone, and thank you for joining us to review first quarter results.

Speaker Change: We have made significant investments over time to optimize our technology and laboratory infrastructure and.

Bob Ragusa: We're making progress toward a vision of population scale, multi-cancer early detection, and remain focused on developing the market.

Speaker Change: And we began the rollout of an enhanced version of the gallery tests in the fourth quarter of last year.

Bob Ragusa: We plan to continue advancing gallery through several key clinical and regulatory milestones that will help unlock broad access while maintaining our disciplined cost management.

Speaker Change: The workflow integrates a significant level of automation among other efficiencies to help support volume at scale and help achieve reductions in costs over time.

Bob Ragusa: The workflow integrates a significant level of automation, among other efficiencies, to help support volume at scale and help achieve reductions in costs over time.

Bob Ragusa: We are very pleased this afternoon to share positive top-line results from the prevalent round of screening in the 140,000-participant NHS Gallery trial.

Speaker Change: Among the recent business highlights, we announced yesterday, a new partnership with the Vienna Health intended to further streamline the gallery test ordering process.

Bob Ragusa: Among the recent business highlights, we announced yesterday a new partnership with the Athena Health intended to further streamline the gallery test ordering process. Gallery's integration within Athena Health's EHR platform, Athena Coordinated Core, can provide a more seamless ordering process for over 160,000 U.S. providers. Additionally, gallery test results will be returned directly in the EHR.

Bob Ragusa: NHS Gallery is one of our two registrational studies, and as Harpo will describe shortly, these results continue to demonstrate strong gallery performance in detecting multiple types of cancers with very low false positive rates.

Galleries integration within the Athena Health EHR platform, all senior coordinator core can provide a more seamless ordering process for over 160000 U S providers.

Bob Ragusa: I'll take a moment to review key achievements in the first quarter before turning it over to Harpal, then Josh will provide a medical and scientific update and Aaron will cover the financial. We are building on our unique position as a first mover in the multi-cancer early detection field with the only commercially available, clinically validated, and said test that has shown the ability to detect many types of cancer. Grail has sold more than 37,000 gallery tests in the first quarter, and as of March 31st, more than 325,000 gallery tests have been prescribed by more than 14,000 health care providers since we launched gallery commercially in 2021.

Speaker Change: Additionally Gallery test results will be returned directly in the EHR.

Speaker Change: I'll take a moment to review key achievements in the first quarter before turning it over to Harpal. Then, Josh will provide a medical and scientific update and Aaron will cover the financials.

Speaker Change: We remain on track for continued commercial growth in $2025 with expected volume growth from Tricare coverage and galleries integration with quest diagnostics ordering system.

Bob Ragusa: We remain on track for continued commercial growth in 2025, with expected volume growth from TRICARE coverage and galleries integration with the Quest Diagnostics ordering system.

Speaker Change: We are building on our unique position as the first mover in the multi-cancer early detection field, with the only commercially available clinically-valivated MCED test that has shown the ability to detect many types of cancer.

Speaker Change: Additionally, we have commercially launched in Israel in partnership with <unk>, which has a strong record in genomic test distribution.

Bob Ragusa: Additionally, we have commercially launched in Israel in partnership with Oncotest, which has a strong record in genomic test distribution. We are pleased to see the initial test orders within that region.

Speaker Change: We are pleased to see the initial test orders within that region.

Speaker Change: Grail us hold more than 37,000 gallery tests in the first quarter and as of March 31st more than 325,000 gallery tests have been prescribed by more than 14,000 healthcare providers since relaunched gallery commercially in 2021.

Speaker Change: Finally, we have initiated a new educational campaign called generation possible John.

Bob Ragusa: Finally, we are initiating a new educational campaign called Generation Possible. Generation Possible's goal is to build public awareness of multi-cancer early detection, and we have partnered with Kate Walsh as a spokesperson to help further the message. The campaign underscores at the patient level the importance of taking control over your health with the option to screen for many of the deadliest cancers before symptoms appear.

Speaker Change: Generation possible goal is to build public awareness of multi cancer early detection and we partnered with Kate Walsh as the spokesperson to help further the message the.

Bob Ragusa: We continue to drive provider and patient awareness of the MSAID opportunity and Galleries' ability to detect cancer early when it is more amenable to treatment. And importantly, we are generating real-world evidence. as our leading health systems and physician practices who have offered MSED as early gallery adopters. We are proud of the demonstrated impact gallery is having on patients lives today, and I'm excited about our technology potential to affect how and when we find cancer on broad scale. We have made significant investments over time to optimize our technology and laboratory infrastructure. And we began the rollout of an enhanced version of the gallery test in the fourth quarter of last year.

Speaker Change: We continue to derive provider and patient awareness of the MFED opportunity and gallery's ability to detect cancer early when it is more amenable to treatment. And importantly, we are generating real-world evidence.

The campaign underscores at the patient level the importance of taking control over your health with the option to screen for many of the deadliest cancers before symptoms appear.

Speaker Change: As our leading health systems and physician practices who have offered and said as early gallery adopters

Speaker Change: More information about generation possible is available at gen possible dot com.

Bob Ragusa: More information about Generation Possible is available at GenPossible.com.

Speaker Change: We are proud of the demonstrated impact gallery is having on patient's lives today and I'm excited about our technology potential to affect how and when we find cancer on broad scale.

Speaker Change: And with that I'll turn it over to her wallet.

Harpal Kumar: And with that, I'll turn it over to Harpal. Thank you, Bob.

Speaker Change: Thank you Bob.

Speaker Change: I am pleased to share high level Gallery test performance results from the intervention.

Harpal Kumar: I'm pleased to share high level gallery test performance results from the intervention arm of the prevalent screening round of our 140,000 participant three year NHS gallery registrational trial. The prevalent screening round was the first round of blood draws with one year of follow-up. We were pleased to see a substantially higher PPV than the 43% observed in the Pathfinder study. We also saw specificity and cancer signal of origin, or CSO, consistent with our Pathfinder study, which was an interventional return of results study evaluating the performance of gallery. As a reminder, Gallery demonstrated specificity of 99.5% and a CSO accuracy of 88% in Pathfinder.

Speaker Change: We have made significant investments over time to optimize our technology and laboratory infrastructure, and we began the rollout of an enhanced version of the gallery tests in the fourth quarter of last year.

Speaker Change: The prevalent screening round of our 140000 participants three year NHS Gallery Registrational trial.

Bob Ragusa: The workflow integrates a significant level of automation among other efficiencies to help support volume at scale and help achieve reductions in costs over time. Among the recent business highlights, we announced yesterday a new partnership with AthenaHealth intended to further streamline the gallery test ordering process. Gallery's integration within Athena Health's EHR platform, Athena Coordinated Core, can provide a more seamless ordering process for over 160,000 U.S. providers. Additionally, gallery test results will be returned directly in the EHR. We remain on track for continued commercial growth in 2025, with expected volume growth from TRICARE coverage and galleries integration with the Quest Diagnostics ordering system.

Speaker Change: The prevalent screening round was the first round of blood draws with one year of follow up.

Speaker Change: The workflow integrates a significant level of automation among other efficiencies to help support the volume at scale and help achieve reductions in costs over time.

Speaker Change: We were pleased to see a substantially higher PPV than the than the 43% observed in the Pathfinder study.

Speaker Change: Among the recent business highlights, we announced yesterday a new partnership with the Athena Health intended to further streamline the gallery test ordering process.

Speaker Change: We also saw specificity and CASM signal of origin or CSO consistent with our Pathfinder study.

Speaker Change: Which was an interventional return of results study evaluating the performance of gallery.

Speaker Change: Galler's inspiration within Athena Health's EHR platform, Athena Coordinator Corps, can provide a more seamless ordering process for over 160,000 U.S. providers.

Speaker Change: As a reminder, gallery demonstrated specificity of 99, 5% and a CSO accuracy of 88% and Pathfinder.

Speaker Change: Additionally, gallery test results will be returned directly in the EHR.

Speaker Change: There were no serious safety concerns and the NHS gallery prevalent screening round also consistent with our Pathfinder study.

Speaker Change: We remain on track for continued commercial growth in 2025 with expected volume growth from trite care coverage and galleries integration with the plus diagnostics ordering system. Additionally, we have commercially launched an Israel in partnership with Enkla Test, which has a strong record in genomic test distribution.

Harpal Kumar: There were no serious safety concerns in the NHS Gallery Prevalence Screening Round, also consistent with the Pathfinder Study.

As Bob mentioned, the topline results from the prevalent screening round of the NHS Gallery trial are very encouraging.

Harpal Kumar: As Bob mentioned, the top line results from the prevalent screening round of the NHS Gallery trial are very encouraging. Results of all three years of the trial are expected in mid-2026. These longitudinal results will be the first clinical utility results of their kind in the MSed field. The NHS Gallery trial was designed as three annual blood draws plus 12 months of follow-up in order to evaluate Gallery's ability to diagnose cancer at an earlier stage relative to standard of care. Cancer screening trials designed to show clinical utility are commonly conducted over three or more years using an annual screening interval.

Speaker Change: The results of all the three years of the trial are expected in mid 2026.

Speaker Change: We are pleased to see the initial test orders within that region.

Bob Ragusa: Finally, we are initiated a new educational campaign called Generation Possible. Generation Possible's goal is to build public awareness of multi-cancer early detection, and we have partnered with Kate Walsh as a spokesperson to help further the message. The campaign underscores at the patient level the importance of taking control over your health with the option to screen for many of the deadliest cancers before symptoms appear. More information about Generation Possible is available at GenPossible.com.

Speaker Change: These long acute interim results will be the first clinical utility results of their kind in the <unk> field.

Speaker Change: Generation Possible's goal is to build public awareness of multi-cancer early detection and we have partnered with Kate Walsh as a spokesperson to help further the message.

Speaker Change: The NHS Gallery trial was designed as three annual blood draws plus 12 months of follow up in order to evaluate galleries ability to diagnose cancer at an earliest stage relative to standard of care.

Harbaugh: The campaign underscores at the patient level the importance of taking control over your health with the option to screen for many of the deadliest cancers before symptoms appear. More information about Generation Possible is available at www.genpossible.com And with that, I'll turn it over to Herbalit.

Speaker Change: Cancer screening trials designed to show clinical utility.

Speaker Change: Commonly conducted over three or more years, using an annual screening interval.

Harpal Kumar: And with that, I'll turn it over to Harbala. Thank you, Bob. I'm pleased to share high level gallery test performance results from the intervention arm of the prevalent screening round of our 140,000 participant three year NHS gallery registrational trial. The prevalent screening round was the first round of blood draws with one year of follow-up. We were pleased to see a substantially higher PPV than the 43% observed in the Pathfinder study. We also saw specificity and cancer signal of origin, or CSO, consistent with our Pathfinder study, which was an interventional return of results study evaluating the performance of gallery.

Speaker Change: Because if screening is only conducted once the results can be influenced by the fact that the first screening round detects many prevalent late stage asymptomatic cancers that have not yet been diagnosed.

Harpal Kumar: Because if screening is only conducted once, results can be influenced by the fact that the first screening round detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed. This and other factors are likely to cause final results of the three-year trial to differ from a review of the first round results.

Thank you Bob.

Harbaugh: I'm pleased to share high-level gallery test performance results from the intervention arm of the prevalent screening round of our 140,000 participants three-year NHS gallery

Speaker Change: And other factors are likely to cause final results of the three year trial to differ from our review of the first round results.

Harbaugh: The prevalent screening round was the first round of blood draws with one year of follow-up.

Speaker Change: NHS Gallery is the largest and only randomized control trial of any set test.

Harbaugh: We were pleased to see a substantially higher PPV than the 43% observed in the Pathfinder study.

Harpal Kumar: NHS Gallery is the largest and only randomised control trial of any MFED test. And the results thus far demonstrate strong gallery performance. Together with England's NHS, we expect to publish detailed data from the ongoing NHS Gallery trial, including the primary end point of an absolute reduction in the number of stage 3 and 4 cancer diagnoses, as well as a number of test performance secondary end points, including episode sensitivity in mid-2026.

Speaker Change: And the results thus far demonstrates strong gallery performance.

Harbaugh: We also saw specificity and cancer signal of origin, or CSO, consistent with our pathfinder study, which was an interventional return of result study evaluating the performance of gallery.

Speaker Change: Together with England, NHS, we expect to publish detailed data from the ongoing NHS Gallery trial, including the primary endpoint of an absolute reduction in the number of stage three and four cancer diagnoses as.

Harpal Kumar: As a reminder, Gallery demonstrated specificity of 99.5% and a CSO accuracy of 88% in Pathfinder. There were no serious safety concerns in the NHS Gallery Prevalence Screening Round, also consistent with the Pathfinder Study. As Bob mentioned, the top line results from the prevalent screening round of the NHS Gallery trial are very encouraging.

Harbaugh: As a reminder, Gallery demonstrated specificity of 99.5% and a CSO accuracy of 88% in Pathfinder.

Speaker Change: As well as a number of test performance secondary endpoints, including episodes sensitivity in made to 2026.

Josh: And with that I'll now hand over to Josh.

Joshua Ofman: And with that, I'll now hand over to Josh. Thanks, Harpal, and hello, everybody.

Josh: Thanks, Paul and Hello, everybody.

Bob Grill: Grill, we have implemented one of the largest clinical evidence programs in the handset space with more than 385000 participants overall.

Bob Ragusa: As Bob mentioned, the top line results from the prevalent screening round of the NHS Gallery trial are very encouraging.

Joshua Ofman: At Grail, we have implemented one of the largest clinical evidence programs in the MSED space, with more than 385,000 participants overall. More than 21,000 participants were included in the studies to support the development and launch of Gallery, and over 170,000 individuals are included in our registrational studies, which support our PMA submission to the FDA.

Harpal Kumar: Results of all three years of the trial are expected in mid-2026. These longitudinal results will be the first clinical utility results of their kind in the MSed field. The NHS Gallery trial was designed as three annual blood draws plus 12 months of follow-up in order to evaluate Gallery's ability to diagnose cancer at an earlier stage relative to standard of care. Cancer screening trials designed to show clinical utility are commonly conducted over three or more years using an annual screening interval. Because if screening is only conducted once, results can be influenced by the fact that the first screening round detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed.

Bob Ragusa: Results of all for three years of the trial are expected in mid-2026.

Speaker Change: More than 21000 participants were included in the studies to support the development and launch of Gallery.

Bob Ragusa: These longitudinal results will be the first clinical utility results of their kind in the Amset field

Speaker Change: And over 170000 individuals are included in our Registrational studies, which support our PMA submission to the FDA.

Bob Ragusa: The NHS Gallery trial was designed as three annual blood draws plus 12 months of follow-up in order to evaluate gallery's ability to diagnose cancer at an earlier stage relative

Speaker Change: Now, let's be clear gallery is working in the real world.

Joshua Ofman: Now, let's be clear. Gallery is working in the real world. We are detecting clinically meaningful cancers and early stage cancers in asymptomatic adults. Our signal detection rate in commercial use is very much in line with what we expected based on our prior clinical study. The majority of the early stage cancers gallery has found are in cancer types where a recommended screening test does not even exist. thereby allowing patients an opportunity to access more effective and even curative treatment.

We arent detecting clinically meaningful cancers and early stage cancers in asymptomatic adults.

Speaker Change: Our signal detection rate in commercial use is very much in line with what we expected based on our prior clinical studies.

Speaker Change: The majority of the early stage cancers gallery is found or in cancer types, where a recommended screening test does not even exist.

Bob Ragusa: Because if screening is only conducted once, results can be influenced by the fact that the first screening round detects many prevalent, late stage asymptomatic cancers that have not yet been diagnosed.

Speaker Change: Thereby allowing patients an opportunity to access more effective and even curative treatments.

Harpal Kumar: This and other factors are likely to cause final results of the three year trial to differ from a review of the first round results. NHS Gallery is the largest and only randomised control trial of any MSED test. And the results thus far demonstrate strong gallery performance. Together with England's NHS, we expect to publish detailed data from the ongoing NHS Gallery trial, including the primary end point of an absolute reduction in the number of stage 3 and 4 cancer diagnoses, as well as a number of test performance secondary end points, including episode sensitivity in mid-2026.

Speaker Change: Now we've described over time, the key performance metrics features and capabilities for multi cancer early detection tests, which importantly are quite different from those for single cancer screenings.

Bob Ragusa: This and other factors are likely to cause final results of the three year trial to differ from a review of the first round results.

Joshua Ofman: Now, we've described over time the key performance metrics, features, and capabilities for multi-cancer early detection tests, which importantly, are quite different from those for single cancer screening. Positive Predictive Value, or PPV, is a key metric which discerns among positive test results, how many are true positive. Specificity, critically important, defines the false positive rate. A very low false positive rate helps reduce unnecessary workups and their associated costs and contributes to driving a high positive predictive value. Our demonstrated specificity at 99.5% equates to a false positive rate of 0.5%. So just to remind you, a 1% reduction in specificity to 98.5% would triple the false positive rate.

Bob Ragusa: NHS Gallery is the largest and only randomized control trial of any MCD test.

Speaker Change: Positive predictive value or PPV as a key metric, which discerns among positive test results. How many are true positives.

and the results thus far demonstrate strong gallery performance.

Bob Ragusa: Together with England to NHS, we expect to publish detailed data from the ongoing NHS gallery trial, including the primary end point of an absolute reduction in the number of stage 3 and 4 cancer diagnoses.

Speaker Change: Specificity critically important defines the false positive rate or very low false positive rate helps reduce unnecessary work ups and their associated costs and contribute to driving a high positive predictive value.

Bob Ragusa: as well as a number of test performance secondary endpoints, including episode sensitivity in

Speaker Change: Our demonstrated specificity at 99, 5%.

Joshua Ofman: And with that, I'll now hand over to Josh. Thanks, Harpal, and hello, everybody. At Grail, we have implemented one of the largest clinical evidence programs in the MSED space, with more than 385,000 participants overall. More than 21,000 participants were included in the studies to support the development and launch of Gallery, and over 170,000 individuals are included in our registrational studies, which support our PMA submission to the FDA.

Speaker Change: Equates to a false positive rate of 0.5%.

And with that, I'll now hand over to Josh.

Thanks, Harpal, and hello, everybody.

Speaker Change: So just to remind you a 1% reduction in specificity to 98, 5% with triple the false positive rate.

Josh: At Grail, we have implemented one of the largest clinical evidence programs in the MCED space with more than 385,000 participants overall.

Speaker Change: That is a <unk>, 5% false positive rate would then become a one 5% false positive rate three times higher.

Joshua Ofman: That is a 0.5% false positive rate would then become a 1.5% false positive rate, three times higher. So applying this to a real world population of a million people tested, instead of there being only 5,000 false positives, there would now be 15,000. Such a reduced specificity would be expected also to result in a positive predictive value about half of what we see at a specificity of 99.5% holding all other metrics.

Speaker Change: So applying this to a real world population of a million people tested instead of there being only 5000 and false positives there would now be 15000.

Joshua Ofman: Now let's be clear. Gallery is working in the real world. We are detecting clinically meaningful cancers and early stage cancers in asymptomatic adults. Our signal detection rate in commercial use is very much in line with what we expected based on our prior clinical study. The majority of the early stage cancers Gallery has found are in cancer types where a recommended screening test does not even exist. thereby allowing patients an opportunity to access more effective and even curative treatment.

Josh: Now, let's be clear, Gallery is working in the real world. We are detecting clinically meaningful cancers and early stage cancers in asymptomatic adults.

Speaker Change: Such a reduced specificity would be expected also to result in a positive predictive value about half of what we see and the specificity of 99, 5% holding all other metrics constant.

Josh: Our signal detection rate in commercial use is very much in line with what we expected based on our prior clinical studies.

Speaker Change: Finally, one of the most important features of a multi cancer early detection test is the ability to localize that cancer center in.

Joshua Ofman: Finally, one of the most important features of a multi-cancer early detection test is the ability to localize that cancer signal. In multi-cancer early detection, CSO capability, or our cancer signal of origin prediction, is the key to guiding physicians to an appropriate and efficient workup to diagnosis. We consistently hear from physicians in the field that this is a critical component of any multi-cancer screening. Even an FDA advisory committee on multi-cancer detection in November 23 similarly emphasized the importance of a cancer signal of origin feature in any multi-cancer detection. Our teams have continued to present evidence demonstrating Gallery's performance at renowned medical conferences.

Josh: The majority of the early stage cancers gallery has found are in cancer types where a recommended screening test does not even exist, thereby allowing patients an opportunity to access more effective and even curative treatments.

Speaker Change: Multi cancer early detection.

Speaker Change: So capability for our cancer signal of origin prediction is the key to guiding physicians to an appropriate and efficient work up to diagnosis.

Joshua Ofman: Now, we've described over time the key performance metrics, features, and capabilities for multi-cancer early detection tests, which importantly, are quite different from those for single cancer screening. Positive Predictive Value or PPV is a key metric. which discerns among positive test results, how many are true positive. Specificity, critically important, defines the false positive rate. A very low false positive rate helps reduce unnecessary workups and their associated costs and contributes to driving a high positive predictive value. Our demonstrated specificity at 99.5% equates to a false positive rate of 0.5%. So just to remind you, a 1% reduction in specificity to 98.5% would triple the false positive rate.

Josh: Now we've described over time the key performance metrics, features and capabilities for multi-cancer early detection tests, which importantly are quite different from those for single-cancer

Speaker Change: We consistently hear from physicians in the field that this is a critical component of any multi cancer screening tests even.

Speaker Change: Even an FDA Advisory committee on multi cancer detection and November 'twenty three similarly emphasize the importance of a cancer single of origin feature in any multi cancer detection test.

Positive predictive value, or PPV, is a key metric.

Josh: which discerns among positive test results how many are true positives.

Speaker Change: Our teams have continued to present evidence demonstrating calories performance at renowned medical conferences.

Josh: Specificity, critically important, defines the false positive rate. A very low false positive rate helps reduce unnecessary workups and their associated costs and contributes to driving a high positive predictive value.

Speaker Change: In April at the ACR meeting, we shared a real world data set on galleries test performance and implementation and over 100000 individuals.

Joshua Ofman: In April at the AACR meeting, we shared a real world data set on gallery's test performance and implementation in over 100,000 individuals. Gallery indeed identified cancers across this large intended-use population, including early-stage cancers and cancers without recommended screening. Generally, the test performance in this real world setting remain consistent with what we've consistently observed in our prior clinical trials. Among other data, we also presented AACR in analysis highlighting the importance of annual screening with an MSED. Model data of post test probabilities of cancers for individuals receiving NSAID tests show that individuals receiving a negative NSAID And they have a reduced risk of late stage cancer diagnosis for one year after the blood drop.

Josh: Our demonstrated specificity at 99.5%, equates to a false positive rate of 0.5%.

Speaker Change: Gallery, indeed identified cancers across this large intended use population, including early stage cancers and cancers without recommended screening.

Josh: So, just to remind you, a 1% reduction in specificity to 98.5% would triple the false positive rate.

Speaker Change: Generally the test performance in this real world setting remain consistent with what we've consistently observed in our prior clinical studies.

Joshua Ofman: That is, a 0.5% false positive rate would then become a 1.5% false positive rate, three times higher. So applying this to a real world population of a million people tested, instead of there being only 5,000 false positives, there would now be 15,000. Such a reduced specificity would be expected also to result in a positive predictive value about half of what we see at a specificity of 99.5% holding all other metrics.

Josh: That is, a .5% false positive rate would then become a 1.5% false positive rate three times higher.

Speaker Change: Among other data we also presented at ACR and analysis, highlighting the importance of annual screening with an M said test <unk>.

Josh: So applying this to a real world population of a million people tested, instead of there being only 5,000 false positives, there would now be 15,000

Speaker Change: Our model data of post test probabilities of cancers for individuals receiving instead test showed that individuals receiving a negative NSAID test.

Speaker Change: And they have a reduced risk of late stage cancer diagnosis for one year. After the blood draw and then this risk increases as the screening interval extends beyond one year.

Joshua Ofman: And then this risk increases as the screening interval extends beyond one year.

Speaker Change: This study really supports the need for annual testing.

Josh: Finally, one of the most important features of a multi-cancer early detection test is the ability to localize that cancer signal.

Speaker Change: Finally, I'd like to highlight the U S health systems are now publishing their own experiences with gallery performance and implementation.

Josh: In multi-cancer early detection, CSO capability or our cancer single-of-origin prediction is the key to guiding physicians to an appropriate and efficient workup to diagnosis.

Speaker Change: Our paper authored by the Mayo Clinic and published recently in March in the journal of primary care and community Health showed the gallery effectively detected cancers, and an asymptomatic population within their health care system and had a 73% positive predictive value in other words, 73%.

Joshua Ofman: A paper authored by the Mayo Clinic and published recently in March in the Journal of Primary Care and Community Health showed that gallery effectively detected cancers in an asymptomatic population within their healthcare system. and had a 73% positive predictive value. In other words, 73% of those with a positive gallery test yielded a confirmed new cancer diagnosis.

Josh: We consistently hear from physicians in the field that this is a critical component of any multi-cancer screening test.

Josh: Even an FDA advisory committee on multi-cancer detection in November 23 similarly emphasize the importance of a cancer signal of origin feature in any multi-cancer detection test.

Speaker Change: <unk> of those with a positive gallery test yielded a confirmed new cancer diagnosis.

Speaker Change: Now the sampling this male clinic analysis was relatively small and had some different patient demographics compared to our prior trials.

Joshua Ofman: Our teams have continued to present evidence demonstrating Gallery's performance at renowned medical conferences. In April at the AACR meeting, we shared a real world data set on gallery's test performance and implementation in over 100,000 individuals. Gallery indeed identified cancers across this large intended use population, including early stage cancers and cancers without recommended screening. Generally, the test performance in this real world setting remain consistent with what we've consistently observed in our prior clinical trials.

Joshua Ofman: Now the sample in this Mayo Clinic analysis was relatively small and had some different patient demographics compared to our prior trial. Importantly, this paper included the Mayo Clinic standardized approach to pursue a diagnostic workup following a positive cancer signal and our signal of origin prediction. The outline steps are informed by a multidisciplinary expert council convened by the Mayo Clinic. Then they reviewed our cancer signal of origin prediction and other data from our first Pathfinder trial. These recommendations continue to be updated, and they've really served as a centralized resource for the Mayo Clinic physicians.

Josh: Our teams have continued to present evidence demonstrating gallery's performance at renowned medical conferences.

Speaker Change: Accordingly. This paper included the Mayo clinic standardized approach to pursue a diagnostic workup following a positive cancer signal and our single origin prediction.

Josh: In April , at the AACR meeting, we shared a real-world data set on galleries, tests, performance and implementation in over 100,000 individuals.

Speaker Change: The outline steps are informed by a multi disciplinary expert council convened by the Mayo Clinic, then they reviewed our canceled symbol of origin prediction and other data from our first Pathfinder trial. These recommendations continue to be updated and they've really served as a centralized resource for the Mayo clinic.

Josh: Gallery indeed identified cancers across this large, intended use population, including early-stage cancers and cancers without recommended screening.

Josh: Generally, the test performance in this real world setting remain consistent with what we've consistently observed in our prior clinical studies.

Speaker Change: <unk>.

Joshua Ofman: Among other data, we also presented AACR in analysis highlighting the importance of annual screening with an MSED. Model data of post-test probabilities of cancers for individuals receiving MCED tests show that individuals receiving a negative MCED test and they have a reduced risk of late-stage cancer diagnosis for one year after the blood drop. And then this risk increases as the screening interval extends beyond one year.

Speaker Change: Now additional health systems, and clinicians who are beginning to publish their experience with gallery up.

Joshua Ofman: Now additional health systems and clinicians are beginning to publish their experience with gallery.

Speaker Change: Coming <unk> 2025 presentations of note include the implementation and evaluation of multi cancer early detection testing at the Dana Farber Cancer Institute a retrospective.

Josh: Model data of post-test probabilities of cancers for individuals receiving inset tests, Sharban individuals receiving a negative m-set test,

Speaker Change: Active analysis of clinical outcomes in diagnostic pathways and an independent analysis by Alabama cancer care titled a clinical review of a novel blood test use in rural Alabama for multi cancer detection analyzing methylation patterns that cell free DNA and.

Josh: And they have a reduced risk of late stage cancer diagnosis for one year after the blood drop. And then this risk increases as the screening interval extends beyond one year.

Joshua Ofman: and an independent analysis by Alabama Cancer Care titled A Clinical Review of a Novel Blood Test Use in Rural Alabama for Multicancer Detection, Analyzing Methylation Patterns of Cell-Free DNA and Future Strategies.

Joshua Ofman: This study really supports the need for annual Finally, I'd like to highlight that U.S. health systems are now publishing their own experiences with gallery performance and implementation. A paper authored by the Mayo Clinic and published recently in March in the Journal of Primary Care and Community Health showed the gallery effectively detected cancers in an asymptomatic population within their healthcare system. and had a 73% positive predictive value. In other words, 73% of those with a positive gallery test yielded a confirmed new cancer diagnosis.

This study really supports the need for annual testing.

Speaker Change: Future strategies.

Josh: Finally, I'd like to highlight that U.S. health systems are now publishing their own experiences with gallery performance and implementation.

Speaker Change: Now looking forward, we anticipate performance data from the first 25000 participants in our other Registrational study Pathfinder two later this year.

Joshua Ofman: Now, looking forward, we anticipate performance data from the first 25,000 participants in our other registrational study, Pathfinder 2, later this year.

Josh: A paper authored by the Mayo Clinic and published recently in March in the Journal of Primary Care and Community Health showed the gallery effectively detected cancers in an asymptomatic population within their health care system.

We also plan to conduct a bridging study between diversion of gallery used in our Registrational trials, NHS calorie and Pathfinder too to the updated version that we plan to submit to the FDA for pre market approval, we plan to submit data from the prevalent screening round of NHS Gallery trial.

Joshua Ofman: We also plan to conduct a bridging study between the version of gallery used in our registrational trials, NHS Gallery and Pathfinder 2, to the updated version that we plan to submit to the FDA for premarket approval. We plan to submit data from the prevalent screening round of the NHS Gallery.

Josh: and had a 73% positive predictive value. In other words, 73% of those with a positive gallery test yielded a confirmed new cancer diagnosis.

Joshua Ofman: Now the sample in this Mayo Clinic analysis was relatively small and had some different patient demographics compared to our prior trial. Importantly, this paper included the Mayo Clinic standardized approach to pursue a diagnostic workup following a positive cancer signal and our signal of origin prediction. The outlined steps are informed by a multidisciplinary expert council convened by the Mayo Clinic. Then they reviewed our cancer signal of origin prediction and other data from our first Pathfinder trial. These recommendations continue to be updated, and they've really served as a centralized resource for the Mayo Clinic physicians.

Speaker Change: The first 25000 participants in the Pathfinder two study and the bridging study as part of our pre market approval application in the first half of 'twenty six.

Speaker Change: Now, the sample in this Mayo Clinic analysis was relatively small and had some different patient demographics compared to our prior trials.

Aaron Freidin: The first 25,000 participants in the Pathfinder 2 study and the bridging study as part of our pre-market approval application in the first half of 20 I'll now hand it over to Aaron for a review of our findings. Thanks, Josh, and good afternoon, everyone.

Speaker Change: Importantly, this paper included the Mayo Clinic's standardized approach to pursue a diagnostic workup following the positive cancer signal and our signal of origin prediction.

Speaker Change: I'll now hand, it over to Erin for a review of our financials.

Erin: Thanks, Josh and good afternoon, everyone I'm pleased to present, our results for the first quarter.

Aaron Freidin: I'm pleased to present our results for the first quarter. First quarter results were strong with revenue of $31.8 million up $5.1 million or 19% as compared to the first quarter of 2024. Total revenue for the quarter is comprised of $29.1 million of screening revenue and $2.7 million of development service revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development. We see continued demand for our gallery test. It sold more than 37,000 tests in the first quarter, a period we have observed historically to be softer relative to the fourth quarter.

Erin: First quarter results were strong with revenue of $31 8 million up $5 1 million or 19% as compared to the first quarter of 2024.

Speaker Change: The outline steps are informed by a multidisciplinary expert council convened by the Mayo Clinic. Then they reviewed our chancellor's signal of origin prediction and other data from our first pathfinder trial.

Erin: Total revenue for the quarter is comprised of $29 $1 million of screening revenue and $2 $7 million of development service revenue development.

Speaker Change: These recommendations continue to be updated and they've really served as a centralized resource for the Mayo Clinic Physicians.

Erin: Development services revenue include services, we provide to biopharmaceutical and clinical customers, including support of clinical studies pilot testing research and therapy development.

Joshua Ofman: Now additional health systems and clinicians are beginning to publish their experience with gallery.

Speaker Change: Now, additional health systems and clinicians are beginning to publish their experience with gallery.

Joshua Ofman: Upcoming ASCO 2025 presentations of note include the implementation and evaluation of multi-cancer early detection testing at the Dana-Farber Cancer Institute. A Retrospective Analysis of Clinical Outcomes and Diagnostic Pathways. and an independent analysis by Alabama Cancer Care titled A Clinical Review of a Novel Blood Test Use in Rural Alabama for Multicancer Detection, Analyzing Methylation Patterns of Cell-Free DNA and Future Strategies.

Erin: We see continued demand for our gallery test that sold more than 37000 tests in the first quarter a period, we have observed historically to be softer relative to the fourth quarter.

Speaker Change: Upcoming ASCO 2025 presentations of note include the implementation and evaluation of multi-cancer early detection testing at the Dana-Farber Cancer Institute.

Erin: Repeat test volumes have moved higher over time, including in early 2025.

Aaron Freidin: Repeat test volumes have moved higher over time, including in early 2025. More than 20% of gallery volume today is repeat test. Grading revenue of $29.1 million in the first quarter was up 24% as compared with the first quarter of 2024. U.S. gallery revenue was $28.7 million, up 22% compared to the first quarter last year, and we were on track relative to full year guidance we shared in January of U.S. gallery revenue growth of 20 to 30%. We do not expect major impacts from tariffs on our current business as our laboratory is located in the U.S.

A retrospective analysis of clinical outcomes and diagnostic pathways.

Erin: More than 20% of gallery volume today is repeat testing.

Speaker Change: and an independent analysis by Alabama Cancer Care titled a clinical review of a novel blood test used in rural Alabama for multi-cancer detection, analyzing methylation patterns of cell-free DNA and future strategies.

Erin: Screening revenue of $29 $1 million in the first quarter was up 24% as compared with the first quarter of 2024.

Erin: U S Gallery revenue was $28 7 million up 22% compared to the first quarter last year and we're on track relative to full year guidance. We shared in January of U S Gallery revenue growth of 20% to 30%, we do not expect major impacts from tariffs on our current business as our laboratory is located in the U S.

Joshua Ofman: Now, looking forward, we anticipate performance data from the first 25,000 participants in our other registrational study, Pathfinder 2, later this year. We also plan to conduct a bridging study between the version of gallery used in our registrational trials, NHS Gallery and Pathfinder 2, to the updated version that we plan to submit to the FDA for premarket approval. We plan to submit data from the prevalent screening round of the NHS Gallery. The first 25,000 participants in the Pathfinder 2 study and the bridging study as part of our pre-market approval application in the first half of 2020.

Speaker Change: Now, looking forward, we anticipate performance data from the first 25,000 participants in our other Registration Study Pathfinder 2 later this year.

Erin: And a significant majority of our suppliers are located in and manufactured in the U S.

Speaker Change: We also plan to conduct a bridging study between the version of gallery used in our registrational trials.

Aaron Freidin: and a significant majority of our suppliers are located in and manufactured in the U.S.

Erin: Net loss for the quarter was $106 2 million, an improvement of 51% as compared to the first quarter of 2024.

Speaker Change: NHS Gallery in Pathfinder 2 to the updated version that we plan to submit to the FDA for pre-market approval. We plan to submit data from the prevalent screening route of the NHS Gallery trial.

Aaron Freidin: Net loss for the quarter was $106.2 million, an improvement of 51% as compared to the first quarter of 2024. and included amortization of intangible assets of $34.6 million and stock-based compensation of $16.2 million. Non-GAAP adjusted gross profit for the first quarter of 2025 was $14.3 million, an increase of $2.3 million or 19% as compared to the first quarter of 2025. We ended the quarter with a cash position of $677.9 million. In January, we guided that we expect cash burn for the full year 2025 to be no more than $320 million. This represents a decrease of more than 40% compared to 2024.

Erin: And included amortization of intangible assets of $34 $6 million and stock based compensation of $16 2 million.

Speaker Change: The first 25,000 participants in the Pathfinder II study and the Bridging Study as part of our pre-market approval application in the first half of 2016.

Erin: non-GAAP adjusted gross profit for the first quarter of 2025 was $14 3 million, an increase of $2 3 million or 19% as competitor to the first quarter of 2024.

Aaron Freidin: I'll now hand it over to Aaron for a review of our financial Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the first quarter. First quarter results were strong with revenue of $31.8 million, up $5.1 million, or 19% as compared to the first quarter of 2024. Total revenue for the quarter is comprised of $29.1 million of screening revenue and $2.7 million of development service revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development. We see continued demand for our gallery test.

Speaker Change: I'll now hand it over to Aaron for review of our financials.

Aaron Freidin: Thanks, Josh, and good afternoon, everyone, and please present our results for the first quarter.

Erin: We ended the quarter with a cash position of $677 9 million.

Aaron Freidin: First quarter results were strong with revenue of 31.8 million dollars up 5.1 million dollars or 19% as compared to the 1st quarter of 2024.

Erin: In January we guided that we expect cash burn for the full year 2025 to be no more than $320 million.

Erin: This represents a decrease of more than 40% compared to 2024 our.

Aaron Freidin: Total revenue for the quarter is comprised of $29.1 million of screening revenue and $2.7 million of development service revenue

Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones.

Aaron Freidin: Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones.

Aaron Freidin: Development Services revenue includes services we provide to biopharmaceutical and clinical customers including support of clinical studies, pilot testing, research and therapy development.

Bob: I'll turn it back to Bob for concluding remarks.

Bob Ragusa: I'll turn it back to Bob for concluding remarks. Thank you, Aaron. To close, we remain encouraged by the demand we are seeing today while we advance towards major milestones, seeking FDA approval of gallery and pursuing broad reimbursement. We are very pleased to have taken additional strides in early 2025, including executing on the transition to the enhanced, more scalable version of Gallery, achieving TRICARE coverage, and enabling easier access to Gallery ordering through Quest Diagnostics and Athena Health. Looking ahead, we expect to share interim data from Pathfinder 2 study in late 2025. That data set will include the first 25,000 of the 35,000 participants enrolled.

Bob: Thank you Erin to close we remain encouraged by the demand we are seeing today, while we advance towards major milestones seeking FDA approval of gallery and pursuing broad reimbursement.

Aaron Freidin: We see continued demand for our gallery test. It sold more than 37,000 tests in the first quarter. A period we have observed historically to be softer relative to the fourth quarter.

Aaron Freidin: It sold more than 37,000 tests in the first quarter, a period we have observed historically to be softer relative to the fourth quarter. Repeat test volumes have moved higher over time, including in early 2025. More than 20 percent of gallery volume today is repeat test. Grading revenue of $29.1 million in the first quarter was up 24% as compared with the first quarter of 2024.

Bob: We are very pleased to have taken additional strides in early 2025, including executing on the transition to the enhanced more scalable version of gallery, achieving tri care coverage and enabling easier access to gallery ordering through quest diagnostics and Athena health.

Aaron Freidin: Repeat test volumes have moved higher over time, including in early 2025. More than 20% of gallery volume today is repeat testing.

Aaron Freidin: Screening revenue of $29.1 million in the first quarter was up 24% as compared with the first quarter of 2024.

Bob: Looking ahead, we expect to share interim data from Pathfinder II study in late 2025 that dataset will include the first 25000 about 35000 participants enrolled.

Aaron Freidin: U.S. gallery revenue was $28.7 million, up 22% compared to the first quarter last year, and we were on track relative to full year guidance. We shared in January of U.S. gallery revenue growth of 20 to 30%. We do not expect major impacts from tariffs on our current business as our laboratory is located in the U.S. and a significant majority of our suppliers are located in and manufactured in the U.S. Net loss for the quarter was $106.2 million, an improvement of 51% as compared to the first quarter of 2024. and included amortization of intangible assets of $34.6 million and stock-based compensation of $16.2 million.

Aaron Freidin: U.S. Gallery Revenue was $28.7 million, about 22% compared to the first quarter last year, and we were on track relative to full year guidance. We shared in January of U.S. Gallery revenue growth of 20 to 30%.

Bob: In 2026 key milestones include the completion of our modular PMA submission to the FDA in the first half and final results from our 140000 participant NHS calories study.

Bob Ragusa: In 2026, key milestones include the completion of our modular PMA submission to the FDA in the first half and final results from our 140,000 participant NHS gallery study.

Aaron Freidin: We do not expect major impacts from terrorists on our current business as our laboratory is located in the U.S. And a significant majority of our suppliers are located in and manufactured in the U.S.

Bob: With that we'll turn the call over to Q&A operator. Please go ahead.

Unknown Executive: With that, we'll turn the call over to Q&A. Operator, please go ahead. Thank you.

Speaker Change: 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.

Aaron Freidin: Net loss for the quarter was $106.2 million in improvement of 51% as compared to the first quarter of 2024.

Unknown Executive: 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. As a reminder, we are allowing analysts one question and one related follow up today. We will wait one moment to allow the queue to form.

Aaron Freidin: and included amortization of intangible assets of $34.6 million and stock-based compensation of $16.2 million.

Speaker Change: When it is your turn Youll hear your name called and receive a pumps terminate as a reminder, we are allowing analysts one question and one related follow up today.

Aaron Freidin: Non-GAAP adjusted gross profit for the first quarter of 2025 was $14.3 million, an increase of $2.3 million or 19% as compared to the first quarter of 2025. We ended the quarter with a cash position of $677.9 million. In January, we guided that we expect cash burn for the full year 2025 to be no more than $320 million. This represents a decrease of more than 40% compared to 2024. Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones.

Aaron Freidin: Non-GAAP adjusted gross profit for the first quarter of 2025 was $14.3 million, an increase of $2.3 million or 19% as compared to the first quarter of 2024.

Speaker Change: Wait one moments to allow the <unk> to form.

Speaker Change: Our first question will come from <unk> with Guggenheim Partners. Please limit your audio and ask your question.

Sugu Nambi: Our first question will come from Sugu Nambi with Guggenheim Partners. Please unmute your audio and ask your question. Hey guys, thank you for taking my question.

Aaron Freidin: We ended the quarter with a cash position of $677.9 million.

Speaker Change: Hey, guys. Thank you for taking my question.

Speaker Change: My first question is back in December the new version of <unk> was starting to be offered with expected short term variable cost improvement can you quantify what those were in the quarter and what should we expect sequentially for the year.

Aaron Freidin: My first question is back in December, the new version of gallery was starting to be offered with expected short term variable cost improvement. Can you quantify what those were in the quarter and what should we expect sequentially for the year? Yeah, thanks for the question. Yeah, so as you said, we did launch at the end of last year. You know, this year, for the first quarter, we were on that new version. And we'd expect to see margins continue to improve over the rest of the year as we increase scale, and just work through the launch transition that we're that we're going through this.

Aaron Freidin: In January , we guided that we expect cashburn for the full year 2025 to be no more than 320 million dollars.

Aaron Freidin: This represents a decrease of more than 40% compared to 2024.

Aaron Freidin: Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones.

Aaron: Aaron you want to.

Aaron: Yes, thanks for the question.

Bob Ragusa: I'll turn it back to Bob for concluding remarks.

Speaker Change: Yes. So as you said, we did launch at the end of last year.

I'll turn it back to Bob for concluding remarks.

Bob Ragusa: Thank you, Aaron. To close, we remain encouraged by the demand we are seeing today while we advance towards major milestones, seeking FDA approval of gallery and pursuing broad reimbursement. We are very pleased to have taken additional strides in early 2025, including executing on the transition to the enhanced, more scalable version of Gallery, achieving TRICARE coverage, and enabling easier access to Gallery ordering through Quest Diagnostics and Athena Health. Looking ahead, we expect to share interim data from Pathfinder 2 study in late 2025. That data set will include the first 25,000 of the 35,000 participants enrolled.

Aaron: Year.

Aaron: For the first quarter.

Aaron: That new version.

Aaron: And we would expect to see margins continue to increase over the rest of the year as we increased scale.

Aaron: And just work through the large transition.

Bob Ragusa: We are very pleased to have taken additional strides in early 2025, including executing on the transition to the enhanced, more scalable version of Gallery, achieving TRICARE coverage and enabling easier access to Gallery ordering through Quest Diagnostics and Athena Health.

We're going through this quarter.

Aaron: As you said youll see those variable Cogs improvements coming over time as we as we move everything over to that new version completely.

Aaron Freidin: You'll as you said, you'll see those variable cogs improvements come over time as we as we move everything over to that the new version completely.

Speaker Change: Got it and then when setting guidance you said you considered quest for instead legislation and try caterpillar.

Aaron Freidin: Got it. And then when setting guidance, you said you considered Quest and said legislation and TRICARE approval. How have those played out to your expectations in one queue? And then is there any upside from here more than what you expected? Yeah, so, you know, early days on both, both Quest as well as TriCare. So we, you know, we are seeing improved ordering from, you know, from Quest providers, they're going through the Quest portal. So that's, that's very encouraging. But again, early days on that. And on TriCare, we're working through the contracting process. So we're, you know, we're in coverage with TriCare, but working through the, you know, the coverage process process with the various contractors there.

Bob Ragusa: Looking ahead, we expect to share interim data from Pathfinder 2 study in late 2025. That data set will include the first 25,000 of the 35,000 participants enrolled.

Speaker Change: Those played out to your expectations in <unk> and then is there any upside from here.

Bob Ragusa: In 2026, key milestones include the completion of our modular PMA submission to the FDA in the first half and final results from our 140,000 participant NHS gallery study.

Speaker Change: More than what you expected.

Bob Ragusa: In 2026, key milestones include the completion of our modular PMA submission to the FDA in the first half and final results from our 140,000 participant NHS gallery study.

Speaker Change: Yes, So you know early.

Speaker Change: Early days on both <unk> as well as Tri care.

Speaker Change: So we.

Operator: With that, we'll turn the call over to Q&A. Operator, please go ahead. 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. As a reminder, we are allowing analysts one question and one related follow up today. We will wait one moment to allow the queue to form.

Speaker Change: We are seeing improved ordering from from plus providers are going through the quest portal.

Bob Ragusa: But that will turn the call over to Q&A. Operator, please go ahead.

Speaker Change: 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.

Speaker Change: So thats very encouraging but again early days on that.

Speaker Change: <unk>, we're working through the contracting process.

Speaker Change: <unk> coverage with Tri care, but working through the the.

Speaker Change: When it is your turn, you will hear your name called and receive a prompt to unmute. As a reminder, we are allowing analysts one question and one related follow-up today. We will wait one moment to allow the queue to form.

Speaker Change: Coverage cross process with the various contractors there.

Speaker Change: So more to come on that later in the year.

Sugu Nambi: So more to come on that later in the year. All right, thank you guys.

Speaker Change: Alright, Thank you guys.

Subbu Nambi: Our first question will come from Subbu Nambi with Guggenheim Partners. Please unmute your audio and ask your question. Hey guys, thank you for taking my question. My first question is back in December, the new version of gallery was starting to be offered with expected short term variable cost improvement. Can you quantify what those were in the quarter and what should we expect sequentially for the year? Yeah, thanks for the question. Yeah, so as you said, we did launch at the end of last year. You know, this year, for the first quarter, we were on that new version.

Speaker Change: Our next question will come from Pedro Savant with Morgan Stanley. Please go ahead.

Speaker Change: Our first question will come from Subunambi with Guggenheim Partners. Please

Tejas Savant: Our next question will come from Tejas Savant with Morgan Stanley. Please go ahead. Hey guys, can you hear me okay? Yeah, yes. Perfect.

Pedro Savant: Hey, guys can you hear me okay.

Subbu Nambi: Hey guys, thank you for taking my question. My first question is back in December, the new version of gallery was starting to be offered with expected short term variable cost improvement. Can you quantify what those were in the quarter and what should we expect sequentially for the year?

Speaker Change: Yes, yes perfect.

Speaker Change: Maybe just one on on the cash burn in the quarter.

Tejas Savant: Um, so maybe just one on on the cash burn in the quarter. I guess, can you help us just think about, you know, the burn trajectory over the course of the next, you know, between now and year end, how you're tracking towards that sort of 320 million or less in burn target that you guys had. And then second, on sort of a related note, you've got a couple of, you know, other NSAID launches coming up here, including one from, you know, an established brand and single cancer screening, so how are you thinking about your OPEX levels, which you've done a good job sort of controlling, so as to keep the burn down?

Speaker Change: I guess can you help us just think about the burn trajectory over the course of the next bill.

Speaker Change: Now in year, and how youre tracking towards that sort of $320 million or less inborn target that you guys had.

Aaron, you want to...

Take that one.

Subbu Nambi: Yes, thanks for the question. Yeah, so as you said, we did launch at the end of last year, you know, this year, for the first quarter, we were on that new version. And we'd expect to see margins continue to improve over the rest of the year as we increase scale, and just work through the launch transition.

Speaker Change: And then second on sort of a related note you have got a couple of.

Speaker Change: Other NSAID launches coming up here, including one from an established brand and single cancer screening. So how are you thinking about your opex levels, which you've done a good job sort of controlling so as to keep the burn down do.

Aaron Freidin: And we'd expect to see margins continue to improve over the rest of the year as we increase scale, and just work through the launch transition that we're that we're going through this You'll as you said, you'll see those variable cogs improvements come over time as we as we move everything over to that the new version completely. Got it.

Robert Ragusa, Joshua Ofman, Unknown Executive

You need to sort of think about re accelerating at a little bit at some of those other offerings make it to market here.

Tejas Savant: Do you need to sort of, you know, think about re-accelerating it a little bit as some of those other offerings make it to market here?

Speaker Change: Yeah.

Aaron: Okay, maybe Aaron you want to take the cash burn won't first Josh.

Aaron Freidin: And then when setting guidance, you said you considered Quest and said legislation and TRICARE approval. How have those played out to your expectations in one Q&A? And then is there any upside from here more than what you expected? Yeah, so, you know, early days on both, both Quest as well as TriCare. So we, you know, we are seeing improved ordering from, you know, from Quest providers that are going through the Quest portal. So that's, that's very encouraging. But again, early days on that. And on TriCare, we're working through the contracting process. So we're, you know, we're in coverage with TriCare, but working through the, you know, the coverage process, process with the various contractors there.

Speaker Change: Got it. And then when setting guidance, you said you considered Quest and said legislation and TRICARE approval. How have those played out to your expectations in one Q&A? And then is there any upside from here more than what you expected?

Aaron Freidin: Maybe Aaron, you want to take the cash burn one first?

Speaker Change: Yes on the cash burn.

Aaron Freidin: Yeah, Tejas. Yeah, on the cash burn. So Q1, I think we burned just under $90 million.

Speaker Change: Q1, I think we burned just under 90 million first quarters period that we pay out our annual bonus from the prior year.

Aaron Freidin: The first quarter is the period that we pay out our annual bonus from the prior year, which is something, of course, it's not going to repeat in the future quarters. Then also, as we talked about margins, just the last question, as we grow more and as margins improve, you know, the cash burn will be in the $320 million range that we Got it. Yeah, go ahead. OpEx and competitors, you know, so it's good actually to see, you know, others investing in multi-cancer early detection as we've, I think we've noted on this call where we've been doing all the heavy lifting in terms of really educating the field of developing the market.

Speaker Change: Which is something of course, its not going to repeat in the future quarters.

Speaker Change: And then also as as we've talked about margins just the last question.

Speaker Change: Yeah, so, you know, early days on, you know, both, both quests as well as, uh, try care.

Speaker Change: As we grow more and as margins improve the cash burn will approach it will be in the $340 million range that we gave.

Speaker Change: So we, you know, we are seeing improved ordering from, you know, from Quest providers that are going through the Quest portal. So that's, that's very encouraging. But again, early days on that. And on Tricare, we're working through the contracting process. So we're

Speaker Change: Got it.

Speaker Change: Yeah go ahead.

Opex and competitors. So it's good actually to see others investing in multi cancer early detection as we've I think we've noted on this call what we've been doing all the heavy lifting in terms of.

Speaker Change: We're in coverage with TRICARE, but working through the coverage process with the various contractors there, so more to come on that later in the year.

Speaker Change: Really educating the field of developing the market.

Aaron Freidin: So more to come on that later in the year.

Speaker Change: We've made unprecedented investments, though to set a very high bar for the field.

Aaron Freidin: You know, we've made unprecedented investments, though, to set a very high bar for the field and, you know, demonstrated really strong specifications based on that. And so, you know, we'll have to take a look and see, you know. You know, from the analysis, what actually transpires in terms of the actual competitive, you know, approaches to see if that's going to have any OPEX, any OPEX impacts on us. So, right now, I would say, it's not clear that we have OPEX impacts from those launches, but, you know, something we'll monitor over the next couple of days.

Subbu Nambi: All right, thank you guys.

Robert, thank you guys.

Tejas Savant: Our next question will come from Tejas Savant with Morgan Stanley. Please go ahead. Hey guys, can you hear me okay? Yeah, yes. Perfect.

Demonstrating really strong specification is based on that.

Speaker Change: Our next question will come from Tejas Savant with Morgan Stanley . Please go ahead.

Speaker Change: And so we'll have to take a look and see.

Speaker Change: From the analysis, what actually transpires in terms of the actual competitive.

Hey guys, can you hear me okay?

Aaron Freidin: Um, so maybe just one on on the cash burn in the quarter. I guess, can you help us just think about, you know, the board trajectory over the course of the next, you know, between now and year end, how you're tracking towards that sort of 320 million or less in board and target that you guys had. And then second, on sort of a related note, you've got a couple of, you know, other MSET launches coming up here, including one from, you know, an established brand and single cancer screening. So how are you thinking about your OPEX levels, which you've done a good job sort of controlling, so as to keep the burn down?

Yeah, yes.

Speaker Change: Approaches to see if thats going to have any opex opex impacts on us. So right now I would say, it's not clear that we have opex impacts from those launches, but something we will monitor over the next couple of quarters.

Perfect.

Speaker Change: So maybe just one on on the cash burn in the quarter. I guess, can you help us just think about, you know, the burn trajectory over the course of the next, you know, between now and year end, how you're tracking towards that sort of 320 million or less in burn target that you guys had. And then second, on sort of a related note, you've got a couple of, you know, other NSAID launches coming up here, including one from, you know, an established brand and single cancer screening. So how are you thinking?

Speaker Change: Got it fair enough.

Speaker Change: And then a couple of quick clean ups on the data side guys. So the intervention arm from the NHS Gallery.

Tejas Savant: Got it. Fair enough.

Tejas Savant: And then a couple of quick cleanups on the data side, guys. So, you know, the intervention arm from the NHS Gallery, that data that you just shared, how should we be thinking about the read across from that your, you know, next year's final NHS Gallery readout, like particularly in terms of that higher PPV you highlighted? And can you put a finer point on when in the second half of the year we can expect Pathfinder 2 data? Yeah, so, you know, on the second question, you know, we're looking to mid next year to have the readout on the full three year study.

Speaker Change: Data that you just shared how should we be thinking about the read across from that your next year. Its final NHS gallery readout like particularly in terms of that higher PPV you highlighted and can you put a finer point on when in the second half of the year, we can expect.

Speaker Change: Speaking about your OPEX levels, which you've done a good job sort of controlling, so as to keep the borne down, do you need to sort of think about reactivating it a little bit as some of those other offerings make it the market here?

Bob Ragusa: Do you need to sort of, you know, think about reaccelerating it a little bit, as some of those other offerings, make make it to market here?

Speaker Change: Finally, two data.

Speaker Change: Yeah. So on.

Speaker Change: And the second question.

Tejas Savant: Maybe Aaron, you want to take the cash burn one first? Yeah, Tejas. Yeah, on the cash burden. So Q1, I think we burned just under $90 million. First quarter's the period that we pay out our annual bonus from the prior year, which is something, of course, it's not going to repeat in the in the future quarters. But also, as we talked about margins, just the last question, as we grow more and as margins improve, you know, the cash burn will be in the $320 million range that we gave. Got it. Yeah, go ahead. OpEx and competitors, you know, so it's good actually to see, you know, others investing in multi-cancer early detection as we've, I think we've noted on this call where we've been doing all the heavy lifting in terms of really educating the field of developing the market.

Speaker Change: Looking to next year to have the readout.

Maybe Aaron, you want to take the cash part first?

Bob: The full three year study, but also have harp all on the call today are Bob maybe answering the first part of that question.

Speaker Change: Yeah, on the cash burden. So Q1, I think we burned just under $90 million. The first quarter is the period that we pay out our annual bonus from the prior year.

Harpal Kumar: We also have Harpal on the call today. So Harpal may be answering the first part of that question. Yeah, sure. Thank you for the question. So look, it's important just to reiterate that the results we've shared today are from the first screening round only. And as we've tried to describe, it's really important that the first round of a screening program, what you typically see is that you are finding a lot of prevalent cancers in the population that have not yet been diagnosed. They are asymptomatic, but they can often be very late stage. And so as we go through to the second and third rounds, and those, you know, those prevalent cancers in the population have already been diagnosed, you know, we would expect to see some differences in the second and third round, as indeed, has other screening programs in the past.

Bob: Yeah sure. Thank you for the question so look.

Speaker Change: It's important just to reiterate that the results. We've shared today are from the first screening round only and as we've as we've tried to describe it is really important.

Speaker Change: which is something, of course, it's not going to repeat in the future quarters. Then also as we talked about margins, just the last question, as we grow more and as margins improve, the cash burn will be in the $320 million range that we gave.

Speaker Change: First round of a screening program. What you typically see is that you are finding a lot of prevalent cancers in the population than that have not yet been not yet been diagnosed.

Got it. Yeah, go ahead. No, don't be be.

Speaker Change: It's topics and competitors, you know, so it's good actually to see, you know, others investing in multi-cancer relief detection as we, I think we've noted on a call where we've been doing all the heavy lifting in terms of.

Speaker Change: They are asymptomatic, but they can often be very late stage and so as we go through to the second and third rounds.

Speaker Change: And those those prevalent cancers in the population have already been diagnosed.

Really educating the field, developing the market.

Joshua Ofman: You know, we've made unprecedented investments, though, to set a very high bar for the field and, you know, demonstrated really strong specifications based on that. And so, you know, we'll have to take a look and see, you know. Unknown Speaker from the announcements, what actually transpires in terms of actual competitive, you know, approaches to see if that's going to have any OpEx impacts on us. So right now, I would say it's not clear that we have OpEx impacts from those launches, but, you know, something we'll monitor over the next couple of days. Got it. Fair enough.

Speaker Change: You know, we've made unprecedented investments though to set a very high bar for the field and you know demonstrate to really strong specifications based on that. And so, you know, we'll have to take a look and see you.

Speaker Change: We would expect to see.

Speaker Change: Some some different season and in the second and third round as indeed has other screening programs and in the past, but we're not we're not we're not.

In a position today to be able to predict what those results will be but we will have those results in mid 'twenty six.

Tejas Savant: But we're not, you know, able to predict what those results will be. But we will have those results in mid-26. Fair enough. Thanks, guys. Appreciate it.

Speaker Change: You know, from the analysis, what actually transpires in terms of the actual competitive, you know, approaches to see if that's going to have any op-x, any op-x impacts on us. So right now, I would say it's not clear that we have op-x impacts from those launches, but, you know, something will monitor over the next couple of quarters.

Speaker Change: Fair enough. Thanks, guys I appreciate it.

Our next question will come from Doug Schenkel with Wolfe Research. Please go ahead.

Doug Schenkel: Our next question will come from Doug Schenkel with Wolf Research. Please go ahead. Hey, good afternoon, everybody. Thank you for taking my questions.

Speaker Change: Hey, good afternoon, everybody. Thank you for taking my questions I wanted to talk about two things the Bmj publication, and then I want to talk about your cash management strategy, which.

Tejas Savant: And then a couple of quick cleanups on the data side, guys.

Got it. Fair enough.

Harpal Kumar: So, you know, the intervention arm from the NHS Gallery, that data that you just shared, how should we be thinking about the read across from that your, you know, next year's final NHS Gallery readout, like particularly in terms of that higher PPV you highlighted?

Speaker Change: And then a couple of quick cleanups on the data side, guys. So, you know, the intervention arm from the NHS gallery, that data that you just shared.

Doug Schenkel: I want to talk about two things, the BMJ publication, and then I want to talk about your cash management strategy, which is obviously top of mind for a lot of us. So, starting on the BMJ publication, as you talked about in your prepared remarks, you demonstrated that annual MCED screening shows a higher projected impact on stage shift and mortality reduction relative to biennial testing. Keeping that in mind, and then also the fact that you've indicated that based on draft MCED legislation that you would assume that ASPs would land in the 500 to 550 level, my questions are, do you believe that the ASP would be unaffected by testing interval, meaning if there's more frequent testing, does the ASP need to come down?

Speaker Change: Is obviously top of mind for a lot of us.

Speaker Change: How should we be thinking about the read across from that your you know next year's final NHS gallery readout like particularly in terms of that higher PPV you highlighted and can you put a finer point on when in the second half of the year we can expect Pathfinder 2 data?

Speaker Change: Starting on the Bmj publication.

Harpal Kumar: And can you put a finer point on when in the second half of the year we can expect Pathfinder 2 data? Yeah, so, you know, on the second question, you know, we're looking to mid next year to have the read out on the full three year study.

Speaker Change: As we've talked about in your prepared remarks, you've demonstrated that annual mcd screening shows a higher projected impact on stage shift and mortality reduction relative to biennial testing so.

Speaker Change: Keeping that in mind.

Speaker Change: Yeah, so, you know, on the second question, you know, we're looking to mid next year to have the readout on the full three year study. Those are part Paul on the call today. So our Paul may be answering the first part of that question.

Speaker Change: Then also the fact that you've indicated that based on draft Mcd legislation that you would assume that Asps would land in the 500 to $5 50 level. My questions are do you believe that.

Harpal Kumar: Most of Harpaul on the call today. So Harpaul may be answering the first part of that question. Yeah, sure. Thank you for the question. So look, it's important just to reiterate that the results we've shared today are from the first screening round only. And as we've tried to describe, it's really important that the first round of a screening program, what you typically see is that you are finding a lot of prevalent cancers in the population that have not yet been diagnosed. They are asymptomatic, but they can often be very late stage. And so as we go through to the second and third rounds, and those, you know, those prevalent cancers in the population have already been diagnosed, you know, we would expect to see some differences in the second and third round, as indeed, has other screening programs in the past.

Speaker Change: Yeah, sure. Thank you for the question. So look, it's important just to reiterate that the results we've shared today are from the first screening round only and as we've as we've tried to describe, it's really important that, you know, the first round of a screening program, what you typically see is that you are. Thank you very much.

Speaker Change: The ASP would be unaffected by testing interval, meaning if theres more frequent testing does the ASP you need to come down and then the second part of the question is when you think about the cost of the system. If there was broad adoption of gallery at that pricing level.

Doug Schenkel: And then the second part of the question is, when you think about the cost to the system, if there was broad adoption of gallery at that pricing level, How, and then you think about, by extension, how much it would cost to find a single cancer. If we think about the cost for cancer detected, including subsequent workups, and even a small number of false positives, would there be any concern in that scenario about the health economics, especially, again, for an annual test?

Speaker Change: How you think about by extension how much it would cost to find a single cancer. If we think about the cost per cancer detected, including subsequent work ups and.

Speaker Change: Finding a lot of prevalent cancers in the population that have not yet been not yet been diagnosed.

Speaker Change: They are asymptomatic, but they can often be very late stage.

Speaker Change: And even a small number of false positives would there be any concern in that scenario about the health economics, especially again for an annual test.

Speaker Change: And so as we go through to the second and third rounds and those prevalent cancers in the population have already been diagnosed, we would expect to see some differences in the second and third round as indeed has other screening programs in the past.

Speaker Change: Yes, Josh do you want to take that one sure sure. So I think as you noted we have a lot of data now to suggest that based on cancer biology.

Joshua Ofman: Josh, do you want to take that one? Sure. So I think as you noted, we have a lot of data now to suggest that based on cancer biology, gallery should be administered on an annual basis. If we want to find early stage asymptomatic cancer based on the rates with which cancers are progressing, given everything we know on the biology of circulating DNA now. So we think that's the right way to go. And all of our pricing strategies and everything we've projected about ASP are based on annual testing. So it's, you know, really too early to speculate on what would happen if we tested more frequently than that.

Speaker Change: Gallery should be administered on an annual basis, if we want to find early stage.

Harpal Kumar: But we're not, you know, able to predict what those results will be. But we will have those results in mid-26. Fair enough.

Speaker Change: But we're not, you know, we're not, we're not in a position today to be able to predict what those results will be. But we will have those results in mid 26.

Speaker Change: Symptomatic cancer based on the rate with which cancers are progressing given everything we know.

Tejas Savant: Thanks, guys. Appreciate it.

Fair enough, thanks guys, appreciate it.

Doug Schenkel: Our next question will come from Doug Schenkel with Wolf Research. Please go ahead. Hey, good afternoon, everybody. Thank you for taking my questions.

Speaker Change: On the biology of circulating DNA now.

Speaker Change: Our next question will come from Doug Schenkel with Wolf Research. Please go ahead.

Speaker Change: So we think that's the right way to go in all of our pricing strategies and everything we've projected about asps are based on annual testing.

Doug Schenkel: Hey, good afternoon, everybody. Thank you for taking my questions. I want to talk about two things, the BMJ publication, and then I want to talk about your cash management strategy, which is obviously top of mind for a lot of us.

Doug Schenkel: I want to talk about two things, the BMJ publication, and then I want to talk about your cash management strategy, which, you know, is obviously top of mind for a lot of us. So, starting on the BMJ publication, you know, as you talked about in your prepared remarks, you demonstrated that annual MCED screening shows a higher projected impact on stage shift and mortality reduction relative to biannual testing. So, keeping that in mind, and then also the fact that you've indicated that based on draft MCED legislation that you would assume that ASPs would land in the 500 to 550 level.

Speaker Change: So it's.

Speaker Change: Really too early to speculate on what would happen if we tested more frequently than that.

Speaker Change: From a health economic perspective.

Joshua Ofman: From the health economic perspective, Doug, it's a great question. We know that with annual testing, even at population scale, At the prices that are in the market today, let alone the lower ASPs that you're commenting on, this is a highly cost-effective intervention. And compared to what we're spending today to diagnose a cancer, given everything that's going on with the false positive rates of current single cancer screening, that the cost to diagnose a cancer with an MSED added to standard of care screening come down substantially. And the numbers needed to screen are much lower than what we've seen traditionally with some of the single cancer screening tests.

Speaker Change: It's a great question, we know that with annual testing, even if population scale.

Doug Schenkel: So starting on the BMJ publication, you know, as you talked about in your prepared remarks, you demonstrated that annual MCED screening shows a higher projected impact on stage shift and mortality reduction relative to biennial testing. So.

Speaker Change: At the prices that are in the market today led.

Speaker Change: Let alone the lower Asp's that youre, commenting on this is a highly cost effective intervention and compared to what we're spending today to diagnose a cancer.

Doug Schenkel: Keeping that in mind, and then also the fact that you've indicated that based on draft MCED legislation that you would assume that ASPs would land in the 500 to 550 level. My questions are, do you believe that

Speaker Change: Given everything that's going on with the false positive rates of current single cancer screening that the cost to diagnose cancer with an NSAID added to standard of care screening come down substantially.

Joshua Ofman: My questions are, do you believe that the ASP would be unaffected by testing interval? Meaning, if there's more frequent testing, does the ASP need to come down? And then the second part of the question is, when you think about the cost to the system, if there was broad adoption of gallery at that pricing level, How, and then you think about by extension, how much it would cost to find, you know, a single cancer. If we think about the cost for cancer detected, including subsequent workups, and, you know, even a small number of false positives, would there be any concern in that scenario about the health economics, especially again for an annual test?

Doug Schenkel: the ASP would be unaffected by testing interval, meaning if there's more frequent testing, does the ASP need to come down? And then the second part of the question is, when you think about the cost to the system, if there was broad adoption of gallery at that pricing level,

Speaker Change: And the numbers needed to screen are much lower than what we've seen traditionally with some of the single cancer screening test so even today the health economic.

Joshua Ofman: So, even today, the health economic data are very compelling from an efficiency and cost-effectiveness perspective. There obviously is a budgetary impact to payers by screening the population for any disease, but it's high-value investment. Okay, thank you for that. Good, good food for thought.

Speaker Change: Data are very compelling from an efficiency and cost effectiveness perspective, there obviously is a budgetary impact.

Doug Schenkel: And then you think about, by extension, how much it would cost to find a single cancer. If we think about the cost for cancer detected, including subsequent workups.

Speaker Change: To payors by screening the population for any disease.

Speaker Change: But it's high value investment.

Speaker Change: And, you know, even a small number of false positives. Would there be any concern in that scenario about the health economics, especially again for an annual test.

Speaker Change: Okay. Thank you for that.

Speaker Change: Good food for thought.

Speaker Change: So the second topic is on cash management and.

Joshua Ofman: Josh, do you want to take that one? Sure. So I think as you noted, we have a lot of data now to suggest that based on cancer biology, gallery should be administered on an annual basis. If we want to find early stage asymptomatic cancer based on the rates with which cancers are progressing, given everything we know on the biology of circulating DNA now. So we think that's the right way to go and all of our pricing strategies and everything we've projected about ASP are based on annual testing.

Doug Schenkel: So, the second topic is on cash management. And, you know, just keeping in mind your stock, at least last I checked is up, you know, about 140% year to date. There are obviously questions about your ability to fund operations through the period where you would plausibly get FDA approval and CMS reimbursement. And again, acknowledging you guys are doing a good job, you know, moving towards. You know, trying to extend the runway as long as possible. There are still concerns you can get there, you know, especially given where we are with the MCED bill and, you know, the path to FDA reimbursement and the approval and CMS reimbursement.

Speaker Change: Yeah, Josh, you want to take that one? Sure, sure. So I think, as you noted, you know, we have a lot of data now to suggest that based on cancer biology,

Speaker Change: Just keeping in mind your stock at least last I checked is up about 140% year to date.

Speaker Change: There are obviously questions about your ability to fund operations through the period, where you would plausibly get FDA approval and CMS reimbursement and again acknowledging you guys are doing.

Speaker Change: Gallery should be administered on an annual basis if we want to find early stage asymptomatic cancer based on the rates with which cancers are progressing given everything we know on the biology of circulating DNA now.

Speaker Change: Good job moving towards.

Speaker Change: Trying to extend the runway as long as possible. There are still concerns you can get there, especially given where we are with the mcd Bill and.

Speaker Change: So we think that's the right way to go. And all of our pricing strategies and everything we've projected about ASP are based on annual testing.

Speaker Change: <unk> path to FDA reimbursement and the power of our approval and CMS reimbursement so.

Joshua Ofman: So it's, you know, really too early to speculate on what would happen if we tested more frequently than that. From the health economic perspective, Doug, it's a great question. We know that with annual testing, even at population scale, At the prices that are in the market today, let alone the lower ASPs that you're commenting on, this is a highly cost-effective intervention. And compared to what we're spending today to diagnose a cancer, given everything that's going on with the false positive rates of current single cancer screening, that the cost to diagnose a cancer with an MSED added to standard of care screening come down substantially.

Speaker Change: So it's, it's, you know, really too early to speculate on what would happen if we tested more frequently than that.

Speaker Change: The best case, recognizing those developments are several years away and also recognizing the NHI NHS Gallery readout, which is pretty critical doesn't read out until next year and at that point your cash position is going to be below half of what it is today.

Doug Schenkel: So, in a best case, recognizing those developments are several years away and also recognizing the NHS gallery readout, which is pretty critical doesn't read out until next year. And at that point, your cash position is going to be below half of what it is today. You know, things start to get a little bit tight.

Speaker Change: From the health economic perspective, Doug, it's a great question. We know that with annual testing, even at population scale,

Speaker Change: At the prices that are in the market today, let alone the lower ASPs that you're commenting on, this is a highly cost-effective intervention.

Speaker Change: You know things start to get a little bit tight so what what was the calculus given all of these facts at the board level behind not raising money to derisk. The outlook. It seems like that would have been a very prudent move to allow you to maybe play offense, a little more aggressively and to make.

Aaron Freidin: So, what was the calculus given all of these facts at the board level behind not raising money to de-risk the outlook? It seems like that would have been a very prudent move to allow you to, you know, maybe play offense a little more aggressively and to make the NHS readout like next year less binary. So, you know, simply put, what's the thinking here? What's the rationale to not take some steps? What are we missing? Yeah, it's a good question. You know, something we've obviously thought about, you know, we, you know, as we've said, in previous discussions, we think that getting through some of these milestones, de-risks the business, and creates value for us.

Speaker Change: And compared to what we're spending today to diagnose a cancer, given everything that's going on with the false positive rates of current single cancer screening, that the cost to diagnose a cancer with an MSED added to standard of care screening comes down substantially.

Speaker Change: NHI NHS readout next year less binary so simply put what what's the thinking here what's the rationale.

Joshua Ofman: And the numbers needed to screen are much lower than what we've seen traditionally with some of the single cancer screening tests. So even today the health economic data are very compelling from an efficiency and cost-effectiveness perspective. There obviously is a budgetary impact to payers by screening the population for any disease, but it's high value investment.

Speaker Change: And the numbers needed to screen are much lower than what we've seen traditionally with some of the single cancer screening tests.

Not take some steps what are we missing.

Doug: Yeah, Doug it's a good question.

Speaker Change: So even today, the health economic data are very compelling from an efficiency and cost effectiveness perspective. There obviously is a budgetary impact to payers by screening the population for any disease, but it's high value investment.

Speaker Change: And we've obviously thought about.

Speaker Change: As we've said in previous discussions we think that getting through some of these milestones derisked the business.

Speaker Change: And creates value for us and so on.

Speaker Change: The calculus, we were look.

Aaron Freidin: And so, you know, in the calculus, we were looking at, you know, getting through some of these major milestones, and knowing that we have the cash runway to get through those was kind of the deciding factor towards, you know, waiting until things play out a little bit, you know, obviously, the stock, as you mentioned, stocks up a bit, that obviously pushes more in the favor of being able to do something, but we still feel we have, you know, substantial cash runway, and we have, you know, relatively near term milestones that will be value created.

Doug Schenkel: Okay, thank you for that. Good, good food for thought.

Speaker Change: He at getting through some of these major milestones and knowing that we have the cash runway to get through those.

Aaron Freidin: So, the second topic is on cash management. And, you know, just keeping in mind your stock, at least last I checked is up, you know, about 140% year to date. There are obviously questions about your ability to fund operations through the period where you would plausibly get FDA approval and CMS reimbursement. And again, acknowledging you guys are doing a good job, you know, moving towards, you know, trying to extend the runway as long as possible. There are still concerns you can get there, you know, especially given where we are with the MCED bill and, you know, the path to FDA reimbursement and the approval and CMS reimbursement.

Speaker Change: Was kind of the deciding factor towards waiting until things play out a little bit obviously the stock is you met your stock's up a bit.

Speaker Change: So the second topic is on cash management. And, you know, just keeping in mind your stock, at least last I checked is up, you know, about 140% year to date.

Speaker Change: That obviously pushes more in favor of being able to do something but we.

Speaker Change: We still feel we have substantial cash runway.

Speaker Change: There are obviously questions about your ability to fund operations through the period where you would plausibly get FDA approval and CMS reimbursement. And again, acknowledging you guys are doing.

Speaker Change: Relatively near term milestones that will be value creating.

Erin: Erin anything okay.

Erin: I mean, I would just add I mean.

Aaron Freidin: Aaron, anything? Yeah, I mean, I would just add, I mean, we're less than a year out from our spin as well. We've got just about $700 million on our balance sheet. So you know, Doug, I think it's something that we're, you know, we're going to continue to look at and work about work on and think about with our board. So it's on our minds. But we're in a good position now in our view. Okay, thanks guys.

a good job, you know, moving towards.

Speaker Change: We're less than a year out from our spend as well we've got just about $700 million on our balance sheet.

Speaker Change: You know, trying to extend the runway as long as possible. There are still concerns you can get there, you know, especially given where we are with the MCED bill and, you know,

Erin: So.

Erin: Doug I think it's something that we're going to continue to look at and talk about think about with our board.

Speaker Change: The path to FDA reimbursement and the path our approval and CMS reimbursement. So, in a best case, recognizing those developments are several years away.

Aaron Freidin: So, in a best case, recognizing those developments are several years away, and also recognizing the NHS gallery readout, which is pretty critical, doesn't read out until next year. And at that point, your cash position is going to be, you know, below half of what it is today. You know, things start to get a little bit tight. So, what was the calculus given all of these facts at the board level behind not raising money to de-risk the outlook? It seems like that would have been a very prudent move to allow you to, you know, maybe play offense a little more aggressively and to make the NHS readout like next year less binary.

Speaker Change: So it is it's on our minds, but were in a good position.

Erin: And our view.

Bob Grill: Okay. Thanks, Scott.

Speaker Change: and also recognizing the NHS gallery readout, which is pretty critical, doesn't read out until next year.

Speaker Change: Our final question will come from Carl Mixon with Canaccord. Please go ahead.

Kyle Mixson: Our final question will come from Kyle Mixon with Canaccord. Please go ahead. Thanks, guys, for the questions.

Carl Mixon: Thanks, guys for the questions just on NHS first just given the data here in the partnership and the study.

Speaker Change: And at that point, your cash position is going to be, you know, below half of what it is today.

Kyle Mixson: Just on NHS first, just given the data here and the partnership and the study, you know, keep progressing, how are the recent conversations with NHS going? And do you, you know, what do you think they're going to do, I guess, with calorie commercialization in the country or following the full readout in 2026?

Speaker Change: You know, things start to get a little bit tight. So what was the calculus given all of these facts?

Speaker Change: Progressing.

Speaker Change: How are the recent conversations with NHS going and do you would you.

Speaker Change: You said theyre going to do I guess with <unk> commercialization in the country are following the full readout in <unk>.

at the board level behind not raising money.

Speaker Change: to de-risk the outlook. It seems like that would have been a very prudent move.

Speaker Change: And then secondly for maybe how Paul talk on the PPD for the subset here that you provided is that like a model number or is that like a concrete et cetera.

Harpal Kumar: And then secondly, for maybe Harpal, on the PPP for the subset here that you provided, is that like a modeled number or is that like a concrete metric? I just want to kind of understand if it's like how the number should be used and how much earlier higher it is compared to a Pathfinder, for example. Yeah, sure. Thanks, Bob. So let me quickly take the second question first. So when we say the PPV was substantially higher in the first round, that's a concrete number. We're not sharing what that number is. But we can say it's substantially higher than the 43% that we saw in Pathfinder.

Speaker Change: to allow you to maybe play offense a little more aggressively and to make the NHS readout next year less binary. So simply put, what's the thinking here? What's the rationale to not take some steps? What are we missing?

Speaker Change: I kind of understand if it's a kind of number should we use.

Aaron Freidin: So, you know, simply put, what's the thinking here? What's the rationale to not take some steps? What are we missing?

Speaker Change: How materially higher it is compared to other Capex for example, thanks.

Speaker Change: Yes.

Speaker Change: Yes sure. Thanks, Bob So let me quickly take the second question first.

Bob Ragusa: Yeah, it's a good question. You know, something we've obviously thought about, you know, we, you know, as we've said, in previous discussions, we think that getting through some of these milestones de-risks the business and creates value for us. And so, you know, in the calculus, we were looking at, you know, getting through some of these major milestones, and knowing that we have the cash runway to get through those was kind of the deciding factor towards, you know, waiting until things play out a little bit, you know, obviously, the stock, as you mentioned, stocks up a bit, that obviously pushes more in favor of being able to do something.

Speaker Change: Yeah, it's a good question. You know, something we've obviously thought about, you know, we, you know, as we've said, in previous discussions, we think that getting through some of these milestones, the risks of business can create value for us. And so, you know, in the calculus, we were looking at, you know, getting through some of these major milestones and knowing that we have to cash runway to get through those.

Speaker Change: So when we say the PPV with substantially higher in the first round.

Speaker Change: That's a concrete number.

Speaker Change: We're not sharing what that number is.

Speaker Change: But we we can say, it's substantially higher than the 43% that we saw in Pathfinder. So it's not a model number.

Harpal Kumar: So it's not a model number. With respect to the conversations with the NHS, I mean, just to say that we're in constant dialogue with the NHS and with the National Screening Committee in the UK and with the government in the UK. They are clear that they want to wait to see final results from all three rounds of the study before they will make a decision as to if and when to roll out a screening programme in the UK or in England particularly. So I can't give you anything more concrete than that at this point other than to say we're in constant dialogue.

Speaker Change: With respect to the conversations with the NHS.

Speaker Change: I mean, just to say that we are in constant dialogue with the NHS and with the National screening Committee in the U K and with the government in the U K.

Speaker Change: was kind of the deciding factor towards, you know, waiting until things play out a little bit. You know, obviously, the stock, as you mentioned, stocks up a bit, that actually pushes more in favor of being able to do something, but we still feel we have

Speaker Change: They are clear that they want to wait to see.

Bob Ragusa: But we still feel we have, you know, substantial cash runway, and we have, you know, relatively near term milestones that will be value creating. Aaron, anything that I would add, I mean, we're less than a year out from our spin as well. We've got just about $700 million on our balance sheet. So you know, Doug, I think it's something that we're, you know, we're going to continue to look at and work about work on and think about with our board. So it is it's on our minds, but we're in a good position now in our Okay, thanks guys.

Speaker Change: Final results from all three rounds of the study.

Speaker Change: substantial cash runway and we have relatively near-term milestones that we'll be value creating.

Speaker Change: Before they will make a decision as to.

Speaker Change: If and when to rollout a screening program in the U K or in England, particularly so.

Aaron Aysing

Speaker Change: I would just add, I mean, we're less than a year out from our spin as well. We've got just about $700 million on our balance sheet.

So I can't give you anything more concrete than that at this point other than to say we are in constant dialogue.

Speaker Change: So, you know, Doug, I think it's something that we're, you know, we're going to continue to look at and work about work on and think about with our board. So it is it's on our minds, but we're in a good position now in our view.

Speaker Change: Paul maybe go through a little bit of why not reveal the numbers right now.

Harpal Kumar: Hey Harpal, maybe go through a little bit of the why not reveal the numbers right now. Yeah, sure. So I mean, it's important to reiterate that the NHS Gallery trial was designed as a three year screening study. In other words, we do three rounds of screening. And that's very common in screening trials and in studies of screening, because for the reasons that I stated earlier on the call, if you only look at one round of screening, then what you'll typically find in that first round is a lot of prevalent asymptomatic cancers in the population, which can often be late stage, but haven't yet been diagnosed.

Paul: Yes sure.

Paul: Important to just reiterate that the NHS Gallery trial.

Paul: Was designed as a three year screening study in other words, we do three rounds of screening and Thats very common in screening trials and studies of screening because for the reasons that I stated earlier on the call if.

Okay. Thanks, guys.

Kyle Mixon: Our final question will come from Kyle Mixon with Canaccord. Please go ahead. Thanks, guys, for the questions.

Speaker Change: Our final question will come from Kyle Mixon with Canaccord. Please go ahead.

Kyle Mixon: Just on NHS First, just given the data here and the partnership and the study, you know, keep progressing, how are the recent conversations with NHS going? And do you, you know, what do you think they're going to do, I guess, with gallery commercialization in the country or following the full readout in 2026?

Speaker Change: Thanks guys for the questions. Just on NHS first, just given the data here and the partnership and the study, you know, keep progressing. How are the recent conversations with NHS going? And do you, you know, what do you think they're going to do, I guess, with calorie commercialization in the country or following the full readout in 2026? And then secondly, for maybe Harpal, on the PPP for the subset here that you provided, is that like a modeled number or is that like a concrete metric? I just want to kind of understand.

Paul: If you only look one round of screening than what you'll typically find in that first round. There is a lot of prevalent asymptomatic cancers in the population, which can often be late stage, but haven't yet been diagnosed by going to our second and third round you start to see what the impact to obey if you like a more established in a steady state screening program.

Harpal Kumar: By going to a second and third round, you start to see what the impact of a, if you like, a more established or steady state screening program might be. And so it's really important that we safeguard those upcoming readouts and the integrity of the trial as a whole. It's also really important that we safeguard the interests of the participants taking part in the trial. And so for all of those reasons, we're not sharing more detailed information at this stage, but we are now getting closer to having the final results middle of next year. And we look forward to sharing all of those, both with all of you, but also with the NHS at that time.

Paul: And so it's really important that we safeguard.

Speaker Change: If it's like how the number should be used and how much earlier higher it is compared to a Pathfinder, for example. Thanks.

Paul: Those.

Paul: Upcoming Readouts and the integrity of the trial as a whole. It's also really important that we safeguard the interest of our participants taking part in the trial and so for all those reasons, we're not sharing more detailed information at this stage.

Harpal Kumar: So let me quickly take the second question first. So so when we say the PPV was substantially higher in the first round, that's a concrete number. We're not sharing what that number is. But we we you know, we can say it's substantially higher than the 43% that we saw in Pathfinder. So it's not a model number.

Speaker Change: Yeah, sure. Thanks, Bob. So let me quickly take the second question first. So when we say the PPV was substantially higher in the first round, that's a concrete number. We're not sharing what that number is, but we can say it's substantially higher than the 43% that we saw in Pathfinder. So it's not a model number.

Paul: But we all know getting closer to having the final results middle of next year, and we look forward to sharing all of those both with all of you, but I will say with the NHS at that time.

Harpal Kumar: With respect to the conversations with the NHS. I mean, just to say that we're in constant dialogue with the NHS and with the National Screening Committee in the UK and with the government in the UK. They are clear that they want to wait to see final results from all three rounds of the study before they will make a decision as to if and when to roll out a screening programme in the UK or in England particularly. So, so I can't give you anything more concrete than that at this point, other than to say we're in constant dialogue.

Speaker Change: With respect to the conversations with the NHS, I mean, just to say that we're in constant dialogue with the NHS and with the National Screening Committee in the UK and with the government in the UK. They are clear that they want to wait to see final results from all three rounds of the study before they will make a decision as to if and when to roll out a screening program in the UK.

Speaker Change: Great that was super helpful and on the topic of repeat testing it sounds like that metric remained stable I think I heard 20%.

Speaker Change: Continues so when you think about repeat testing, what's an acceptable number at this point do you like 20% how do you improve the stickiness in that recurring revenue stream and then how does movement in that number affect your modeling the bulk ASP and customer acquisition costs over the medium term.

Speaker Change: Yes. So first of all we're very pleased with above 20% given that we're generally not a reimbursed tests, we think that compares very favorably to reimburse test.

Andy Partridge: Yeah, so first of all, we're very pleased with above 20%. You know, given that we're generally not a reimbursed test, we think that compares very favorably to to reimburse tests in the market. So, you know, the 20% mark, we expect to continue to be able to grow that. But, you know, we need a little more time under our belts to figure out exactly where that's going to go. From a, you know, clearly from a customer acquisition cost, that certainly helps the model being able to have that repeat base at that significant level. So, that is something we are factoring in into our modeling.

Speaker Change: Okay. All right. All right. All right. Bye bye. Bye bye. Bye. Bye. All right. Bye. Well, I've got to go. We've got to go. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Bye. Okay, so you. Let's get back to the problem. Okay. All right.

Aaron Freidin: Aaron, I'll maybe go through a little bit of the why not reveal the numbers right now. Yeah, sure. So I mean, it's important to reiterate that the NHS gallery trial was designed as a three year screening study. In other words, we do three rounds of screening. And that's very common in screening trials and in studies of screening, because for the reasons that I stated earlier on the call, if you only look at one round of screening, you'll typically find in that first round is a lot of prevalent asymptomatic cancers in the population, which can often be late stage but haven't yet been diagnosed.

Speaker Change: Hey, I'll maybe go through a little bit of the why not reveal the numbers right now.

Speaker Change: In the market.

Speaker Change: So.

Speaker Change: The 20% Mark we expect to continue to be able to grow that.

Speaker Change: We need a little more time on their belts to figure out exactly where that's going to go from.

Speaker Change: From a.

Speaker Change: screening study. In other words, we do three rounds of screening. And that's very common in screening trials and in studies of screening because

Speaker Change: Clearly from a customer acquisition cost that's really helps the model being able to have that repeat base.

Speaker Change: Significant level so.

Speaker Change: So that is something we are factoring in into our modeling.

Speaker Change: For the reasons that I stated earlier on the call, if you only look at one round of screening, then what you'll typically find in that first round is a lot of prevalent asymptomatic cancers in the population, which can often be late stage but haven't yet been diagnosed.

Speaker Change: Great, Thanks, Rob and E&E.

Andy Partridge: Great. Thanks for having me, Andy. Thank you.

Speaker Change: Okay.

Speaker Change: Thank you there are no further questions at this time I will now turn the call back to ground for closing remarks.

Harpal Kumar: By going to a second and third round, you start to see what the impact of a, if you like a more established or steady state screening program might be. And so it's really important that we safeguard those upcoming readouts and the integrity of the trial as a whole. It's also really important that we safeguard the interests of the participants taking part in the trial. And so for all of those reasons, we're not sharing more detailed information at this stage.

Unknown Executive: There are no further questions at this time.

Speaker Change: By going to a second and third round, you start to see what the impact of a, if you like, a more established or steady state screening program might be.

Unknown Executive: I will now turn the call back to Grail for closing remarks. So thank you everyone for joining today's call.

Speaker Change: So thank you everyone for joining today's call.

Speaker Change: Ladies and gentlemen, this concludes the call you may now disconnect.

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

Speaker Change: And so for all of those reasons, we're not sharing more detailed information at this stage. But we are now getting closer to having the final results middle of next year. And we look forward to sharing all of those, both with all of you, but also with the NHS at that time.

Kyle Mixon: But we are now getting closer to having the final results middle of next year. And we look forward to sharing all of those, both with all of you, but also with the NHS at that time. Great, that was super helpful.

Kyle Mixon: And on the topic of repeat testing, it sounds like that metric remains stable. I think I heard 20% continues. So, you know, when you think about repeat testing, what's an acceptable number at this point? You know, do you like 20%? How do you improve the stickiness and that recurring kind of revenue stream? And then how does movement in that number affect your modeling of like ASP and customer acquisition cost over the medium term? Yeah, so first of all, we're very pleased with above 20%. You know, given that we're generally not a reimbursed test, we think that compares very favorably to to reimburse tests in the market.

Great, that was super helpful.

Speaker Change: And on the topic of repeat testing, it sounds like that metric remains stable. I think I heard 20% continues. So, you know, when you think about repeat testing, what's an acceptable number at this point? You know, do you like 20%? How do you improve the stickiness and that recurring kind of revenue stream? And then how does movement in that number affect your modeling of ASP and customer acquisition cost over the medium term? Unknown Speaker

Speaker Change: Yeah, so first of all, we're very pleased with above 20%. You know, given that we're generally not a reimbursed test, we think that compares very favorably to to reimburse tests in the market.

Andy Partridge: So, you know, the 20% mark, we expect to continue to be able to grow that. But, you know, we need a little more time when there are belts to figure out exactly where that's going to go. From a, you know, clearly from a customer acquisition cost, that certainly helps the model being able to have that repeat base at that significant level. So, that is something we are factoring in into our modeling.

Speaker Change: You know, clearly from a customer acquisition class that that certainly helps the model being able to have that repeat base at that significant level. So that is something where we are factoring in into our modeling.

Andy Partridge: Great, thanks for having me, Andy. Thank you.

Thanks for having me, Andy.

Operator: There are no further questions at this time.

Bob Ragusa: I will now turn the call back to Grail for closing remarks. So thank you everyone for joining today's call.

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

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

Q1 2025 GRAIL Inc Earnings Call

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