Q2 2024 GRAIL Inc Earnings Call

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Operator: Welcome to the second quarter 2024 earnings call. At this time, all participants are in listen-only mode.

Operator: I can call to 2024 earnings call. At this time, our participants are in listen-only mode.

Speaker Change: Good day ladies and gentlemen and welcome to the Grail second quarter 2024 earnings call. At this time all participants are in listen-only mode. After the speaker's presentation there'll be a question and answer session. Please be advised this conference call is being recorded. Grail investor relations please begin.

Operator: 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. Thank you.

Operator: After the speaker's presentation, there'll be a question-and-answer session. Please be advised this conference call is being recorded.

Unknown Executive: Grow investor relations, please begin. Thank you. And thank you all for joining us today.

Grail Investor Relations: And thank you all for joining us today. On the call today are Bob Ragusa, our Chief Executive Officer, Aaron Frieden, our Chief Financial Officer, Dr. Joshua Offman, our President, and Zohar Pokhomire, our President of BioPharma Business in Europe. Before we get underway, I'd like to remind everybody that 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 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 28 of the Securities Act of 1933, as amended, and Section 21 of the Securities Exchange Act of 1934, Forward-looking statements are subject to risks and uncertainties. The actual events or results may differ materially from those projected or discussed.

Robert Ragusa: On the call today, Robert Ragusa, our Chief Executive Officer, Aaron Freidin, our Chief Financial Officer, Dr. Joshua Ahmed, our President, and Dr. Harkbokumar, our President, by the Department of Business and Europe. Before we get underway, I'd like to remind everybody that we'll 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 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 28 of the Securities Act of 1933, as amended, and Section 21 of the Securities Exchange Act of 1934, as amended.

Speaker Change: Thank you. And thank you all for joining us today. On the call today are Bob Ragusa, our Chief Executive Officer, Aaron Frieden, our Chief Financial Officer, Dr. Joshua Offman, our President, and Dhruv Harpalkumar, our President, Biopharma Business in Europe.

Grail Investor Relations: All forward-looking statements are based on currently available information, and Grail assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Grail files with the Securities and Exchange Commission, including the Risk Factor section in Grail's most recent quarterly report on Form 10-Q. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss and adjusted EBITDA, which are adjusted to exclude certain specified items.

Speaker Change: Before we get underway, I'd like to remind everybody that we will be making forward-looking statements on this call based on current expectations.

Grail Investor Relations: Our non-GAAP financial measures are intended to supplement your understanding of Grails Financials. Reconciliations of the non-GAAP measures to the most directly comparable GAAP financial measures are available in the press release issued today, which is posted on our website. With that, I'll turn the call over to Bob. Thank you and good afternoon, everyone.

Speaker Change: It is 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 28 of the Securities Act of 1933.

Speaker Change: amended and section 21 of the Securities Exchange Act of 1934 as amended.

Robert Ragusa: Forward-looking statements are subject to risks and uncertainties. Actual events and results may differ materially; most projected or discussed. All forward-looking statements are based upon currently available information, and Growl 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 growl files with the Securities and Exchange Commission, including the risk factor section, and growl most recently quarterly report on Form 10-Q.

Speaker Change: [inaudible]

Speaker Change: 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 GRELL assumes no obligation to update these statements.

Speaker Change: To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that GRAIL files with the Securities and Exchange Commission, including the Risk Factor section in GRAIL's most recently quarterly report on Form 10-Q.

Robert Ragusa: This call will also include a discussion of gap results and certain non-gap financial measures, including adjusted growth profit or loss and adjusted EBITDA, which are adjusted to exclude certain specified items. Our non-gap financial measures are intended to supplement your understanding of growth financials. Reconciliation of the non-GAAP measures to the most directly comparable GAAP financial measures is available in the press release issued today, which is posted to our website.

Speaker Change: This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss and adjusted EBITDA, which are adjusted to exclude certain specified items.

Bob Ragusa: Our non-GAAP financial measures are intended to supplement your understanding of Grails financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website. With that, I'll turn the call over to Bob.

Robert Ragusa: With that, I'll turn the call over to Bob. Thank you and good afternoon, everyone. We are pleased to review our second quarter results with you today. Today's call we will discuss the market opportunity for Gallery, our clinically validated multi-cancer early detection blood tests, our performance in the second quarter, and the progress we continue to make to change the paradigm in early cancer detection. We will also review the corporate restructuring announced today, which extends our existing cash runway into 2028. Grail is focused on detecting cancer early when it can be cured. Curb recommended screening is limited, and most deadly cancers are found too late.

Bob Ragusa: We are pleased to review our second quarter results with you today. On today's call, we will discuss the market opportunity for Gallery, our clinically validated multi-cancer early detection blood tests, our performance in the second quarter, and the progress we continue to make to change the paradigm in early cancer detection. We will also review the corporate restructuring announced today, which extends our existing cash runaway into 2028. Grail is focused on detecting cancer early when it can be cured. Current recommended screening is limited, and most deadly cancers are found too late. Multicancer Early Detection, or MSED, is the solution for effective population screening.

Bob Ragusa: Thank you and good afternoon, everyone.

Bob Ragusa: We are pleased to review our second quarter results with you today. On today's call, we will discuss the market opportunity for gallery, our clinically validated multi-cancer early detection blood tests, our performance in the second quarter, and the progress we continue to make to change the paradigm in early cancer detection.

Bob Ragusa: We will also review the corporate restructuring announced today, which extends our existing cash runway into 2028.

Bob Ragusa: GRAIL is focused on detecting cancer early when it can be cured.

Bob Ragusa: Current recommended screening is limited and most deadly cancers are found too late.

Robert Ragusa: Multi-cancer early detection or M-set is the solution for effective population screening. The market for M-set is rapidly evolving, with over 100 million individuals eligible for the gallery tests in the United States and more than 300 million in global target markets. Grail's robust clinical validation and commercial launch as a laboratory developed test, or LDT, and our significant laboratory capacity and scalability makes us well suited to address one of the most meaningful opportunities in healthcare. Importantly, the gallery test was designed for population-scale screening. We have an expansive clinical evidence program, which is setting the standard in M-set development.

Bob Ragusa: Multi-cancer early detection, or MSED, is the solution for effective population screening. The market for MSED is rapidly evolving with over 100 million individuals eligible for the gallery test in the United States and more than 300 million in global target markets.

Bob Ragusa: The market for MSED is rapidly evolving, with over 100 million individuals eligible for the gallery test in the United States and more than 300 million in global target markets. Grail's robust clinical validation and commercial launch as a Laboratory-Developed Test, or LDT, and our significant laboratory capacity and scalability make us well-suited to address one of the most meaningful opportunities in healthcare. Importantly, the gallery test was designed for population-scale screening.

Braille: Braille's robust clinical validation and commercial launch as a laboratory-developed test, or LDT, and our significant laboratory capacity and scalability makes us well-suited to address one of the most meaningful opportunities in healthcare.

Braille: Importantly, the gallery test was designed for population-scale screening. We have an expansive clinical evidence program which is setting the standard in MSED development.

Bob Ragusa: We have an expansive clinical evidence program that is setting the standard for MSED development. We are breaking new ground, and over a period of years, we have consistently progressed through key milestones for the business. We have progressed our FDA Pre-Market Approval Application, or PMA, Registrational Studies, and a few weeks ago, we announced we had completed the final study visits for 140,000 participants in the NHS Gallery Study and had completed the enrollment in the 35,000-participant Pathfinder II Study. We expect to submit our PMA with the clinical data from these two trials and other supplemental data in the first half of 2026.

Robert Ragusa: We are breaking new ground, and over a period of years, we have consistently progressed through key milestones for the business. We have progressed our FDA pre-market approval application for PMA, registration studies, and a few weeks ago we announced we have completed the final study visits for 140,000 participants in the NHS Gallery study and it completed the enrollment in the 35,000 participants Pathfinder 2 study. We expect to submit our PMA with the clinical data from these two trials and other supplemental data in the first half of 2026. We also announced in July that we have enrolled the first participant in the gallery Medicare study called the REACH Study.

Braille: We are breaking new ground and over a period of years, we have consistently progressed through key milestones for the business.

Braille: We have progressed our FDA premarket approval application, or PMA, registrational studies, and a few weeks ago we announced we have completed the final study visits for 140,000 participants

Braille: in the NHS Gallery Study and have completed the enrollment in the 35,000 Participant Pathfinder II Study. We expect to submit our PMA with the clinical data from these two trials and other supplemental data in the first half of 2026.

Bob Ragusa: We also announced in July that we have enrolled the first participant in the Gallery Medicare study called the REACH study. This real-world evidence study is planned to enroll 50,000 Medicare beneficiaries for three annual tests to generate additional clinical validation and utility data in the Medicare population. Medicare beneficiaries are among the most at risk for cancer due to age and other risk factors, and this population represents an enormous unmet need for early cancer detection.

Braille: We also announced in July that we have enrolled the first participant in the Gallery Medicare study called the REACH study.

Robert Ragusa: This real-world evidence study is planned to enroll 50,000 Medicare beneficiaries for three annual tests to generate additional clinical validation and utility data in the Medicare population. Medicare beneficiaries are among the most at risk for cancer due to age and other risk factors, and this population represents an enormous unmet need for early cancer detection. This study is intended to help support a Medicare coverage analysis following FDA approval. We remain pleased with the man for gallery that we're seeing in the pre-reinversive environment through June 30th of this year, and more than 215,000 commercial gallery tests have been prescribed by more than 11,000 healthcare providers.

Braille: This real-world evidence study is planned to enroll 50,000 Medicare beneficiaries for 3 annual tests to generate additional clinical validation and utility data in the Medicare population.

After the speakers presentation, there'll be a question and answer session.

Braille: Medicare beneficiaries are among the most at risk for cancer due to age and other risk factors and this population represents an enormous unmet need for early cancer detection.

Unknown Executive: Please be advised this conference call is being recorded. Grow investor relations, please begin. Thank you. And thank you all for joining us today.

Bob Ragusa: This study is intended to help support a Medicare coverage analysis following FDA approval. We remain pleased with the Manford Gallery that we're seeing in the pre-reimbursement environment. Through June 30th of this year, more than 215,000 commercial gallery tests have been prescribed by more than 11,000 health care providers. Rail is an established market leader in the field, and we are proud of the impact the gallery is having on patients' lives. Following a portfolio review, we are reprioritizing our resources on our core MSED priorities and reducing overall spend as we progress towards completion of our registrational studies and our FDA EMA submissions.

Braille: This study is intended to help support a Medicare coverage analysis following FDA approval.

Unknown Executive: On the call today, Robert Ragusa, our Chief Executive Officer, Aaron Freidin, our Chief Financial Officer, Dr. Joshua Ahmed, our President, and Dr. Harkbokumar, our President, by the Department of Business and Europe. Before we get underway, I'd like to remind everybody that we'll 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 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 28 of the Securities Act of 1933 as amended, and section 21 of the Securities Exchange Act of 1934 as amended.

Speaker Change: We remain pleased with the demand for gallery that we're seeing in the pre-reimbursement environment. Through June 30th of this year, more than 215,000 commercial gallery tests have been prescribed by more than 11,000 healthcare providers.

Robert Ragusa: Rail is an established market leader in the field, and we are proud of the impact a gallery is having on patient slides. Following a portfolio review, we are reprioritizing our resources on our core MCED priorities and reducing overall spend as we progress towards completion of our registration studies and our FDA EMA submission. We believe these actions will extend our anticipated cash runway from the second half of 2026 into 2028 and provide for greater flexibility. It is important to note that we do not expect that the reductions in spend and headcount will impact our PMA submission timing or NHS gallery or the Pathfinder 2 resorts.

Speaker Change: Braille is an established market leader in the field and we are proud of the impact the gallery is having on patients lives.

Speaker Change: Following a portfolio review, we are reprioritizing our resources on our core MSED priorities and reduce overall spend as we progress towards completion of our registrational studies and our FDA EMA submission.

Bob Ragusa: We believe these actions will extend our anticipated cash runway from the second half of 2026 into 2028 and provide for greater flexibility. It is important to note that we do not expect that the reductions in spend and head count will impact our PMA submission timing or the NHS gallery for the Pathfinder to read out.

Speaker Change: We believe these actions will extend our anticipated cash runway from the second half of 2026 into 2028 and provide for greater flexibility.

Unknown Executive: Forward-looking statements are subject to risks and uncertainties. Actual events and results may differ materially, most projected or discussed. All forward-looking statements are based upon currently available information, and growl 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 growl files with the Securities and Exchange Commission, including the risk factor section, and growl most recently quarterly report on form 10Q.

Speaker Change: It is important to note that we do not expect that the reductions in spend and headcount will impact our PMA submission timing or NHS gallery or the Pathfinder 2 readouts.

Robert Ragusa: As a result of focusing our resources on achieving broad gallery reimbursement in the U.S. and UK, we are reducing existing headcount and plan 2024 hires by approximately 30%. On our commercial team, we've been working to understand which investments provide the greatest return and have identified measurable impact from our most successful strategies. As a result, we are streamlining our commercial sales force and medical service teams and focusing our field-based activities on the most productive current customers and high-priority opportunities. We are maintaining sales force coverage for the majority of our current gallery volume and active subscribers. As part of this approach, we are also streamlining investments in our enterprise business, which includes our employer and life insurance businesses.

Bob Ragusa: As a result of focusing our resources on achieving broad gallery reimbursement in the U.S. and U.K., we are reducing the existing headcount and planned 2024 hires by approximately 30 percent. On the commercial team, we've been working to understand which investments provide the greatest return and have identified measurable impact from our most successful strategies. As a result, we are streamlining our commercial sales force and medical affairs teams and focusing our field-based activities on the most productive current customers and high-priority opportunities.

Speaker Change: As a result of focusing our resources on achieving broad gallery reimbursement in the U.S. and UK, we are reducing the existing headcount and planned 2024 hires by approximately 30 percent.

Unknown Executive: This call will also include a discussion of gap results and certain non-gap financial measures, including adjusted growth profit or loss and adjusted EBITDA, which are adjusted to exclude certain specified items. Our non-gap financial measures are intended to supplement your understanding of growth financials.

Speaker Change: On our commercial team, we've been working to understand which investments provide the greatest return and have identified measurable impact from our most successful strategies.

Speaker Change: As a result, we are streamlining our commercial sales force and medical affairs teams and focusing our field-based activities on the most productive current customers and high priority opportunities.

Reconciliation of the non-gap measures to most directly comparable gap financial measures are available in the press release issue today, which is posted to our website.

Bob Ragusa: We are maintaining salesforce coverage for the majority of our current gallery volume and active prescribers. As part of this approach, we are also streamlining investments in our enterprise business, which includes our employer and life insurance businesses. Reductions in the commercial organization include management layers and commercial roles without sales responsibility. In addition to reductions in commercial, we are making reductions in medical affairs teams involved with U.S. gallery provider engagement. We are substantially decreasing investment in R&D related to our diagnostic aid for cancer and our minimum residual disease program.

Robert Ragusa: With that, I'll turn the call over to Bob. Thank you and good afternoon, everyone. We are pleased to review our second quarter results with you today.

Speaker Change: We are maintaining sales force coverage for the majority of our current gallery volume and active prescribers.

Speaker Change: As part of this approach, we are also streamlining investments in our enterprise business, which includes our employer and life insurance businesses.

Robert Ragusa: Today's call we will discuss the market opportunity for gallery, our clinically validated multi-cancer early detection blood tests, our performance in the second quarter, and the progress we continue to make to change the paradigm in early cancer detection. We will also review the corporate restructuring announced today, which extends our existing cash runaway into 2028. Grail is focused on detecting cancer early when it can be cured. Curb recommended screening is limited and most deadly cancers are found too late.

Robert Ragusa: Reductions in the commercial organization include management layers and commercial roles without sales responsibilities. In addition to reductions in commercial, we are making reductions in medical service teams involved with U.S. Gallery provider engagement. We are substantially decreasing investment in R&D related to our diagnostic aid for cancer and our minimum residual disease programs. In addition, we are making reductions in GNA to reflect the focus on our MCED opportunity. We will continue to invest in our biopharmaceutical partnerships and are committed to working with our partners to leverage Grail's proprietary methylation technology in precision ontology applications.

Speaker Change: Reductions in the commercial organization include management layers and commercial roles without sales responsibilities. In addition to reductions in commercial, we are making reductions in medical affairs teams involved with US gallery provider engagement.

Speaker Change: We are substantially decreasing investment in related to our diagnostic aid for cancer and our minimum residual disease programs.

Bob Ragusa: In addition, we are making reductions in GNA to reflect the focus on our MSET opportunity. We will continue to invest in our biopharmaceutical partnerships and are committed to working with our partners to leverage Grail's proprietary methylation technology in precision oncology applications. This restructuring and resulting staff reductions are difficult, and we are immensely grateful to our employees who have worked hard to enable Grail's success to date and helped transition MSED from an idea into a reality.

Speaker Change: In addition, we are making reductions in GNA to reflect the focus on our MSET opportunity. We will continue to invest in our biopharmaceutical partnerships and are committed to working with our partners to leverage GRAIL's proprietary methylation technology in precision oncology applications.

Robert Ragusa: Multi-cancer early detection or M-set is the solution for effective population screening. The market for M-set is rapidly evolving with over 100 million individuals eligible for the gallery tests in the United States and more than 300 million in global target markets. Grail's robust clinical validation and commercial launch as a laboratory developed test, or LDT, and our significant laboratory capacity and scalability makes us well suited to address one of the most meaningful opportunities in healthcare.

Robert Ragusa: This restructure and result in staff reductions are difficult, and we are immensely grateful to our employees who have worked hard to enable Grail's success to date and help transition MCED from an idea into our reality.

Speaker Change: This restructure and result in staff reductions are difficult and we are immensely grateful to our employees who've worked hard to enable Grail success to date and help transition MSED from an idea into a reality. We wish all of our impacted employees well.

Aaron Freidin: We wish all of our impacted employees well. To discuss our second quarter financial results, I'll hand it over to Grail's Chief Financial Officer, Aaron Freidin. Thanks, Bob, and good afternoon, everyone. Please present our results for the second quarter. Second quarter results were strong in the revenue of $32 million, up $9.6 million or 43% as compared to Q2 of 2023. Total revenue for the first half of the year was 58.7 million, an increase of 40% as compared to the same period in 2023. Total revenue for the quarter is comprised of 28.2 million of screening revenue and 3.8 million of development service revenue.

Bob Ragusa: We wish all of our impacted employees well. To discuss our second quarter financial results, I'll hand it over to Grail's Chief Financial Officer, Aaron Frieden. Thanks, Bob, and good afternoon, everyone, and please present our results for the second quarter. Second quarter results were strong, with revenue of $32 million, up $9.6 million or 43% as compared to Q2 of 2023. Total revenue for the first half of the year was $58.7 million, an increase of 40% as compared to the same period in 2023. Total revenue for the quarter was comprised of $28.2 million of screening revenue and $3.8 million of development service revenue.

Aaron Frieden: 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 and sold approximately 35,200 tests in the second quarter. Screening revenue of $28.2 million in the second quarter was up 41% as compared with the second quarter of 2023. Screening revenue for the first half of 2024 was $51.7 million, an increase of 45% as compared with the same period last year. The net loss for the quarter was $1.59 billion, an increase of 721% as compared to Q2 of 2023.

Speaker Change: To discuss our second quarter financial results, I'll hand it over to Grail's Chief Financial Officer, Aaron Frieden.

Robert Ragusa: Importantly, the gallery test was designed for population scale screening. We have an expansive clinical evidence program which is setting the standard in M-set development. We are breaking new ground and over a period of years we have consistently progressed through key milestones for the business. We have progressed our FDA pre-market approval application for PMA, registration studies and a few weeks ago we announced we have completed the final study visits for 140,000 participants in the NHS gallery study and it completed the enrollment in the 35,000 participants Pathfinder 2 study.

Aaron Frieden: The increase was driven by a goodwill and intangible impairment of $1.42 billion in addition to an increase in general and administrative expenses related to legal and professional services associated with the divestiture, and higher employee compensation expenses due to an increased headcount and employee long-term incentives. We additionally report non-GAAP financial measures to enhance investors' understanding of our business. These measures include adjusted gross profit or loss and adjusted EBITDA and exclude accounting impacts related to Illumina's acquisition of Grail.

Aaron Frieden: Thanks, Bob and good afternoon. Everyone I'm pleased to present our results for the 2nd quarter.

Aaron Frieden: Second quarter results were strong with revenue of $32M, up $9.6M or 43% as compared to Q2 of 2023. Total revenue for the first half of the year was $58.7M, an increase of 40% as compared to the same period in 2023.

Aaron Frieden: Total revenue for the quarter is comprised of 28.2Million of screening revenue and 3.8Million of development service revenue.

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. We see continued demand for our gallery test and sold approximately 35,200 tests in the second quarter. Screening revenue of 28.2 million in the second quarter was up 41%, as compared with the second quarter of 2023. Screening revenue for the first half of 2024 was 51.7 million, an increase of 45% as compared with the same period last year.

Aaron Frieden: Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies.

Robert Ragusa: We expect to submit our PMA with the clinical data from these two trials and other supplemental data in the first half of 2026. We also announced in July that we have enrolled the first participant in the gallery Medicare study called the REACH study. This real-world evidence study is planned to enroll 50,000 Medicare beneficiaries for three annual tests to generate additional clinical validation and utility data in the Medicare population. Medicare beneficiaries are among the most at risk for cancer due to age and other risk factors and this population represents an enormous unmet need for early cancer detection.

Aaron Frieden: pilot testing, research, and therapy development.

Aaron Frieden: We see continued demand for our gallery test and sold approximately 35,200 tests in the second quarter.

Aaron Frieden: Screening revenue of $28.2 million in the second quarter was up 41% as compared with the second quarter of 2023.

Aaron Frieden: Screening revenue for the 1st half of 2024 was 51.7M, an increase of 45% as compared with the same period last year. Net loss for the quarter was 1.59B, an increase of 721% as compared to Q2 of 2023.

Aaron Freidin: Net loss for the quarter was $1.59 billion, an increase of 721% as compared to Q2 of 2023. The increase was driven by a goodwill and intangible impairment of 1.42 billion, in addition to an increase in general and administrative expenses related to legal and professional services associated with the same period. Screening revenue of 28.2 million in the second quarter of 2023 was a goodwill and intangible impairment of 1.42 billion in the second quarter of 2023. We additionally report non-GAAP financial measures to enhance investors' understanding of our business. These measures include adjusted growth profit or loss and adjusted EBITDA and exclude accounting impacts related to the aluminum acquisition of Grail.

Robert Ragusa: This study is intended to help support a Medicare coverage analysis following FDA approval. We remain pleased with the man for gallery that we're seeing in the pre-reinversive environment through June 30th of this year and more than 215,000 commercial gallery tests have been prescribed by more than 11,000 healthcare providers. Rail is an established market leader in the field and we are proud of the impact a gallery is having on patient slides.

Aaron Frieden: The increase was driven by a goodwill and intangible impairment of 1.42 billion, in addition to an increase in general and administrative expenses related to legal and professional services associated with the divestiture.

Aaron Frieden: and higher employee compensation expenses due to an increased headcount and employee long-term incentive awards.

Aaron Frieden: We additionally report non-GAAP financial measures to enhance investors' understanding of our business.

Robert Ragusa: Following a portfolio review, we are reprioritizing our resources on our core MCED priorities and reduce overall spend as we progress towards completion of our registration studies and our FDA EMA submission. We believe these actions will extend our anticipated cash runway from the second half of 2026 into 2028 and provide for greater flexibility. It is important to note that we do not expect that the reductions in spend and headcount will impact our PMA submission timing or NHS gallery or the Pathfinder 2 resorts.

Aaron Frieden: These measures include adjusted gross profit or loss and adjusted EBITDA.

Aaron Frieden: and exclude accounting impacts related to Illumina's acquisition of Grail. We encourage investors to carefully consider results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations. Available in our second quarter earnings press release.

Aaron Freidin: We encourage investors to carefully consider results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations available in our second quarter earnings press release. Non-GAAP adjusted growth profit for the second quarter of 2024 was $16 million, an increase of $6.4 million, or 66%, as compared with Q2 of 2023. Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased gallery volume. Adjusted EBITDA for the second quarter of 2024 was a negative $139.4 million, representing an increased loss of $2.8 million, or 2%, as compared to Q2 of 2023.

Aaron Frieden: We encourage investors to carefully consider results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations, available in our second quarter earnings press release. Non-GAAP-adjusted gross profit for the second quarter of 2024 was $16 million, an increase of $6.4 million, or 66%, as compared with Q2 2023. Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased gallery volume. Adjusted EBITDA for the second quarter of 2024 was negative $139.4 million, representing an increased loss of $2.8 million or 2% as compared to Q2 of 2023. The decrease in adjusted EBITDA was driven by higher operating expenses, including one-time transaction expenses partially offset by revenue growth over the prior year period.

Aaron Frieden: Non-GAAP adjusted gross profit for the 2nd quarter of 2024 was $16M, an increase of $6.4M or 66% as compared with Q2 of 2023.

Aaron Frieden: Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased gallery volume.

Robert Ragusa: As a result of focusing our resources on achieving broad gallery reimbursement in the U.S, and UK, we are reducing existing headcount and plan 2024 hires by approximately 30%. On our commercial team, we've been working to understand which investments provide the greatest return and have identified measurable impact from our most successful strategies. As a result, we are streamlining our commercial sales force and medical service teams and focusing our field-based activities on the most productive current customers and high priority opportunities.

Aaron Frieden: Adjusted EBITDA for the second quarter of 2024 was negative 139.4 million dollars. Representing an increased loss of 2.8Million dollars or 2% as compared to Q2 of 2023.

Aaron Freidin: The decrease in the Justin Ibita was driven by higher operating expenses, including one-time transaction expenses, partially offset by revenue growth over the prior year period.

Aaron Frieden: The decrease in adjusted EBITDA was driven by higher operating expenses, including one-time transaction expenses, partially offset by revenue growth over the prior year period.

Aaron Freidin: We have an ending cash position of $958.8 million as of June 30, 2024. We recognize the importance of preserving cash runway as we progress gallery through the FDA approval process and work toward broad reimbursement, and at today, take in some difficult steps to ensure the financial health and flexibility of the company. We expect these cost reductions to enable a significant reduction in burn in 2025 and beyond and extend our existing cash runway into 2028. In 2024, we expect $27 million in savings and net of anticipated severance benefit costs. Turning to guidance, with the expense reductions announced today, we expect our previous estimate of $250 million in cash burn, and the second half of 2024 will come down to approximately $220 million.

Aaron Frieden: We have an ending cash position of $958.8 million as of June 30, 2024. We recognize the importance of preserving cash runway as we progress gallery through the FDA approval process and work toward broad reimbursement, and have today taken some difficult steps to ensure the financial health and flexibility of the company. We expect these cost reductions to enable a significant reduction in burn in 2025 and beyond and extend our existing cash runway into 2028. In 2024, we expect $27 million in savings net of anticipated severance benefit costs.

Aaron Frieden: We have an ending cash position of $958.8 million as of June 30th, 2024.

Robert Ragusa: We are maintaining sales force coverage for the majority of our current gallery volume and active subscribers. As part of this approach, we are also streamlining investments in our enterprise business, which includes our employer and life insurance businesses. Reductions in the commercial organization include management layers and commercial roles without sales responsibilities. In addition to reductions in commercial, we are making reductions in medical service teams involved with U.S, gallery provider engagement. We are substantially decreasing investment in R&D related to our diagnostic aid for cancer and our minimum residual disease programs.

Speaker Change: We recognize the importance of preserving cash runway as we progress gallery through the FDA approval process and work toward broad reimbursement and have today taken some difficult steps to ensure the financial health and flexibility of the company.

Speaker Change: We expect these cost reductions to enable a significant reduction in burn in 2025 and beyond, and extend our existing cash runway into 2028. In 2024, we expect 27M dollars in savings, net of anticipated severance benefit costs.

Robert Ragusa: In addition, we are making reductions in GNA to reflect the focus on our MCED opportunity. We will continue to invest in our biopharmaceutical partnerships and are committed to working with our partners to leverage Grail's proprietary methylation technology in precision ontology applications.

Aaron Frieden: Turning to guidance, with the expense reductions announced today, we expect our previous estimate of $250 million in cash burn in the second half of 2024 to come down to approximately $220 million. We expect burn in 2025 to come down significantly compared to 2024, with full-year burn in 2025 expected to be approximately $325 million. We expect that our 2024 US gallery revenue will be in line with our guidance in May of 30 to 50% growth over 2023.

Speaker Change: Turning to guidance, with the expense reductions announced today, we expect our previous estimate of $250 million in cash burn in the second half of 2024 will come down to approximately $220 million.

Aaron Freidin: We expect burn in 2025 to come down significantly compared to 2024, with full year burn of 2025 expected to be approximately $325 million. We expect that our 2024 U.S. Gallery revenue will be in line with our guidance in May of 30% to 50% growth over 2023; however, with our reductions announced today, we plan for gallery revenue to grow more moderately in 2025 and subsequent years until we receive broad reimbursement.

Speaker Change: We expect burn in 2025 to come down significantly compared to 2024, with full year burn of 2025 expected to be approximately $325 million.

Robert Ragusa: This restructure and result in staff reductions are difficult, and we are immensely grateful to our employees who have worked hard to enable Grail's success to date and helps transition MCED from an idea into our reality.

Speaker Change: We expect that our 2024 U.S. gallery revenue will be in line with our guidance in May of 30 to 50 percent growth over 2023. However, with the reductions announced today, we plan for gallery revenue to grow more moderately in 2025 and subsequent years until we receive broad reimbursement.

Aaron Frieden: However, with the reductions announced today, we plan for Gallaudet revenue to grow more moderately in 2025 and subsequent years until we receive broad reimbursement. I'll turn it back to Bob to speak to our strategic priorities. Bob, go ahead.

Aaron Freidin: We wish all of our impacted employees well to discuss our second quarter financial results I'll hand it over to Grail's Chief Financial Officer Aaron Freidin. Thanks, Bob, and good afternoon, everyone, and please present our results for the second quarter. Second quarter results were strong in the revenue of $32 million, up $9.6 million or 43% as compared to Q2 of 2023. Total revenue for the first half of the year was 58.7 million, an increase of 40% as compared to the same period in 2023.

Robert Ragusa: I will turn it back to Bob to speak to our strategic priorities.

Robert Ragusa: Bob, go ahead. Thank you, Aaron. We are a mission-driven company, and we are focused on improving cancer care and enabling broad use of gallery. Real-world use of gallery has detected many of the most aggressive cancers in early stages, including pancreatic, head and neck, a soft material, liver, and stomach cancers. For the majority of these cancer types, there are no other screening options available. We are passionate about our mission and energized by the powerful stories we have heard from patients who have benefited from Gallery and from physicians and health systems that are successfully implementing Gallery into their practice.

Speaker Change: I'll turn it back to Bob to speak to our strategic priorities. Bob, go ahead.

Bob Ragusa: Thank you, Aaron. We are a mission-driven company, and we are focused on improving cancer care and enabling broad use of galleries. Real-world use of Gallery has detected many of the most aggressive cancers in their early stages, including pancreatic, head and neck, esophageal, liver, and stomach cancers. For the majority of these cancer types, there are no other screening options available.

Bob Ragusa: Thank you, Aaron.

Bob Ragusa: We are a mission-driven company, and we are focused on improving cancer care and enabling broad use of Gallery. Real-world use of Gallery has detected many of the most aggressive cancers in early stages, including pancreatic, head and neck, esophageal, liver, and stomach cancers.

Speaker Change: For the majority of these cancer types, there are no other screening options available. We are passionate about our mission and energized by the powerful stories we have heard from patients who have benefited from GALORE and from physicians and health systems that are successfully implementing GALORE into their practice.

Aaron Freidin: Total revenue for the quarter is comprised of 28.2 million of screening revenue and 3.8 million of development service revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customer, including support of clinical studies, pilot testing research, and therapy development. We see continued demand for our gallery test and sold approximately 35,200 tests in the second quarter. Screening revenue of 28.2 million in the second quarter was up 41%, as compared with the second quarter of 2023. Screening revenue for the first half of 2024 was 51.7 million, an increase of 45% as compared with the same period last year.

Bob Ragusa: We are passionate about our mission and energized by the powerful stories we have heard from patients who have benefited from gallery and from physicians and health systems that are successfully implementing gallery into their practice. We are looking forward to continuing to progress our mission, and we are committed to operating with discipline and being prudent with our spend. This year, we expect to continue enrollment in the Gallery, Medicare, or REACH study, drive access to Gallery, and advance our commercial and research partnership. We will continue to release data at scientific and medical meetings, including at ESMO in September. We also anticipate results from the first 25,000 participants in the Pathfinder II study in the second half of 2025.

Robert Ragusa: We are looking forward to continuing our to progress our mission, and we are committed to operating with discipline and being prudent with our spend. This year, we expect to continue enrollment in the gallery Medicare or REIT study, drive access to gallery and advance our commercial and research partnerships. We will continue to release data at scientific and medical meetings, including at EZMO in September. We also anticipate results from the first 25,000 participants in the Pathfinder II study in the second half of 2025. Looking beyond, we are tightly focused on our strategic goals, seeking FDA approval of Gallery and pursuing broad reimbursement for Gallery.

Speaker Change: We are looking forward to continuing to progress our mission, and we are committed to operating with discipline and being prudent with our spend.

Speaker Change: This year, we expect to continue enrollment in the Gallery, Medicare, or REACH study, drive access to Gallery, and advance our commercial and research partnerships.

Speaker Change: We will continue to release data at scientific and medical meetings, including at ESMO in September. We also anticipate results from the first 25,000 participants in the Pathfinder 2 study in the second half of 2025.

Aaron Freidin: Net loss for the quarter was $1.59 billion, an increase of 721% as compared to Q2 of 2023. The increase was driven by a goodwill and intangible impairment of 1.42 billion in addition to an increase in general and administrative expenses related to legal and professional services associated with the same period. Screening revenue of 28.2 million in the second quarter of 2023 was a goodwill and intangible impairment of 1.42 billion in the second quarter of 2023.

Operator: Looking beyond, we are tightly focused on our strategic goals, seeking FDA approval of GALOREA and pursuing broad reimbursement for GALOREA. 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.

Speaker Change: Looking beyond, we are tightly focused on our strategic goals, seeking FDA approval of gallery and pursuing broad reimbursement for gallery. With that, we'll turn the call over to Q&A. Operator, please go ahead.

Operator: With that, we'll turn the call over to Q&A.

Operator: Operator, please go ahead. Thank you.

Operator: 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. You may unmute your audio and ask your question. As a reminder, we are allowing and list one question and one related follow-up today. We will wait one moment to allow the queue to fall. 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: We additionally report non-gap financial measures to enhance investors understanding of our business. These measures include adjusted growth profit or loss and adjusted EBITDA and exclude accounting impacts related to aluminum acquisition of Grail. We encourage investors to carefully consider results under gap in conjunction with our supplemental non-gap information and the reconciliation between these presentations available in our second quarter earnings press release. Non-gap adjusted growth profit for the second quarter of 2024 was $16 million, an increase of $6.4 million or 66% as compared with Q2 of 2023.

Operator: When it is your turn, you will hear your name called; you may unmute your audio and ask your question. As a reminder, we are allowing at least one question and one related follow-up today. We will wait one moment to allow the queue to form.

Speaker Change: When it is your turn, you will hear your name called, you may unmute your audio and ask your question. As a reminder, we are allowing analysts one question and one related follow-up today.

Speaker Change: We will wait one moment to allow the cue to form.

Pyle Nixon: Our first question is from Pyle Nixon at Canacol. Please unmute yourself and begin with your question. Hey guys, thanks for the questions and thanks for the miss update, Paul. I guess there hasn't been a multi-cancer detection test like this scaled in the past, and now you're getting cash burned down to levels of other precision college companies. What gives you confidence that this level of investment is enough to commercial service products?

Operator: Thank you. Our first question is from... Kyle Nixon at Canaccord. Please unmute yourself and begin with your question. Hey guys, thanks for the questions. And thanks for doing this update, Paul. So I guess, um, you know, there hasn't been a multi-cancer detection test like this scaled in the past.

Speaker Change: Thank you. Our first question is from...

Speaker Change: Kyle Nixon at Canaccord. Please unmute yourself and begin with your question.

Kyle Nixon: Hey guys, thanks for the questions, and thanks for doing this update, Paul. So I guess, you know, there hasn't been a multi-cancer detection test like this scaled in the past, and now here you're kind of getting cash burned down to levels of like, you know, other precision oncology companies.

Aaron Freidin: Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased gallery volume. Adjusted EBITDA for the second quarter of 2024 was a negative $139.4 million, representing an increased loss of $2.8 million or 2% as compared to Q2 of 2023. The decrease in the Justin Ibita was driven by higher operating expenses, including one time transaction expenses, partially offset by revenue growth over the prior year period. We have an ending cash position of $958.8 million as of June 30, 2024.

Speaker Change: What gives you confidence that this level of investment is enough to commercialize this type of product?

Robert Ragusa: Pyle, thanks for the question. We've looked really carefully at our portfolio and recognized that by focusing on end-setting and getting to the key inflection points, particularly FDA approval of our PMA and then on the path to broad reimbursement, is really critical for us. That's what a lot of the changes were driven by. We've done a very careful review of what it takes to get there. We're quite comfortable that we have the resources aligned to be able to go down that pathway successfully. In that area around M-set, we actually made relatively few changes. We're staying consistent on our timeline.

Bob Ragusa: And now here, you're kind of burning cash to levels of like, you know, other precision oncology companies. What gives you confidence that this level of investment is enough to, you know, commercialize this type of product? Gail, thanks for the question. You know, we've looked really carefully at our portfolio and, you know, recognize that, particularly, FDA approval of our PMA and then, you know, on the path to broad reimbursement are really critical for us. And so that's what a lot of the changes were driven by.

Paul: Thanks for the question. We've looked really carefully at our portfolio.

Speaker Change: you know, recognize that, you know, by focusing on MCEP and getting to the key inflection points, particularly, you know, FDA.

Speaker Change: FDA approval of our PMA.

Speaker Change: And then, you know, on the path to broad reimbursement is really critical for us. And so that's what a lot of the changes were driven by. We've, you know, we've...

Bob Ragusa: We've, you know, we did a very careful review of what it takes to get there, and so we're quite comfortable that we have the resources aligned to be able to go down that pathway successfully. We, you know, in that area around MSED, actually made relatively few changes.

Aaron Freidin: We recognize the importance of preserving cash runway as we progress gallery through the FDA approval process and work toward broad reimbursement, and at today, take in some difficult steps to ensure the financial health and flexibility of the company. We expect these cost reductions to enable a significant reduction in burn in 2025 and beyond and extend our existing cash runway into 2028. In 2024, we expect $27 million in savings and net of anticipated severance benefit costs.

Speaker Change: Did a very careful review of what it takes to get there. And so we're quite comfortable that

Speaker Change: We have the resources aligned to be able to go down that pathway successfully.

Speaker Change: We, you know, in that area around em said, we actually made relatively few changes. We, you know, we're staying consistent on our timeline. We're saying, because it's on the effort that we're applying.

Bob Ragusa: We, you know, we're staying consistent on our timeline. We're staying consistent on the effort that we're applying that we're applying to that area. It's really in other areas around DAC, MSED, and some of the commercial elements that we've, you know, that we pulled back from. So, you know, we're all those helpful. Yeah, so we're comfortable. Thanks again, sorry for cutting you off.

Pyle Nixon: We're saying this is on the effort that we're applying to that area. It's really in other areas around DAC, M-set, and some of the commercial elements that we pulled back from. We're talking about those helpful. Thanks again. Sorry for coming you off.

Speaker Change: we're applying to that to that area. It's really in other areas around DAC, MSED, and some of the commercial elements that we've you know that we pulled back from.

Aaron Freidin: Turning to guidance, with the expense reductions announced today, we expect our previous estimate of $250 million in cash burn, and the second half of 2024 will come down to approximately $220 million. We expect burn in 2025 to come down significantly compared to 2024, with full year burn of 2025 expected to be approximately $325 million. We expect that our 2024 U.S, gallery revenue will be in line with our guidance in May of 30% to 50% growth over 2023, however, with our reductions announced today, we plan for gallery revenue to grow more moderately in 2025 and subsequent years until we receive broad reimbursement.

Speaker Change: So, you know, we're all those helpful. Yeah. So we're comfortable.

Robert Ragusa: Just related follow up. How will these cost products be phased in? I understand you're kind of implementing this now, I guess, but it's kind of mid-year, so I'm just curious about this and how it faces into the burn targets for next year. When will MRD and DAC investments come back and how important are those still for the companies like long-long term growth profile? The actions will occur immediately. We're taking MRD and DAC. We believe we have great opportunities in both of those. We think our methylation technology is very well suited to those. On the precision oncology side, we're continuing to support our biopharma partners in that.

Kyle Nixon: Just a related follow-up question, how will these cost reductions be phased in? I understand you're kind of implementing this now, I guess, but it's kind of mid-year. So just curious about this and how it phases into the burn targets for next year. And then when will MRD and DAC investments come back? And how important are those still for the company's long, long-term growth profile?

Speaker Change: You know, thanks again, sorry for cutting you off.

Speaker Change: Just a related follow-up, how will these and when will these cost reductions be phased in? I understand you're kind of implementing this now, I guess, but it's kind of mid-year, so just curious about this and how it phases into the burn targets for next year. And then when will MRD and DAC investments come back, and how important are those still for the company's long, long-term growth profile?

Bob Ragusa: Yeah, so the actions will occur immediately. So we're taking action right now to generate the cost savings that we're outlining. In terms of MRD and DAC, we believe we have great opportunities in both of those. We think our methylation technology is very well suited to both.

Speaker Change: Yeah, so the actions will occur immediately. So we're taking action right now to generate the cost savings that we're outlining.

Robert Ragusa: I will turn it back to Bob to speak to our strategic priorities. Bob, go ahead. Thank you, Aaron.

Robert Ragusa: We are a mission-driven company and we are focused on improving cancer care and enabling broad use of gallery. Real-world use of gallery has detected many of the most aggressive cancers in early stages, including pancreatic, head and neck, a soft material, liver and stomach cancers. For the majority of these cancer types, there are no other screening options available. We are passionate about our mission and energized by the powerful stories we have heard from patients who have benefited from gallery and from physicians and health systems that are successfully implementing gallery into their practice.

Speaker Change: In terms of MRD and DAC, we believe we have great opportunities in both of those. We think our methylation technology is very well-suited to those. And on the

Bob Ragusa: And on the precision oncology side, we're continuing to support our biopharma partners in that. So that work will continue. The pure DAC and MRD work, though, we're pausing future developments in those areas. And we haven't set a timeline for reinvesting in those areas at this point, again, because the focus is really to drive MSED through the key inflection points. Got it. Okay. I can hop back in the queue.

Speaker Change: Precision Oncology's side, we're continuing supporting our biopharma partners in that. So that work will continue. The PureDAC and MRD work though, we're pausing future developments in those areas.

Robert Ragusa: That work will continue on the pure DAC and MRD work; though, we're causing future developments in those areas. We haven't set a timeline for reinvesting in those areas at this point. Again, because the focus is really to drive and set through the key inflection point.

Speaker Change: And, you know, we haven't set a timeline for, you know, kind of reinvesting in those areas at this point, again, because the focus is really to drive MSED through the key inflection points.

Robert Ragusa: We are looking forward to continuing our to progress our mission and we are committed to operating with discipline and being prudent with our spend. This year, we expect to continue enrollment in the gallery Medicare or REIT study, drive access to gallery and advance our commercial and research partnerships. We will continue to release data at scientific and medical meetings, including at EZMO in September. We also anticipate results from the first 25,000 participants in the Pathfinder II study in the second half of 2025. Looking beyond, we are tightly focused on our strategic goals, seeking FDA approval of gallery and pursuing broad reimbursement for gallery.

Speaker Change: Got it. Okay. I can hop back in the queue. Thanks for inviting me.

Tejas Savant: The next question is from Tejas Savant at Morgan Stanley. Please unmute yourself and begin with your question. Hey guys, can you hear me okay? Yeah, yeah. Okay, perfect. All right, so a quick follow-up there on Kyle's question.

Operator: Thanks for watching. The next question is from Tejas Savant at Morgan Stanley. Please unmute yourself and begin with your question. Hey guys, can you hear me okay?

Speaker Change: The next question is from Tejas Savant at Morgan Stanley. Please unmute yourself and begin with your question.

Speaker Change: Please unmute yourself and begin with your question.

Operator: Yeah. Yeah. Okay, perfect. All right.

Tejas Savant: So a quick follow-up on Kyle's question. Aaron, could you just give us a better sense for where the largest cost savings will come from? You know, I know you highlighted all the areas in the call, but just in terms of the magnitude of the contributions from each area, some color there would be great. Yeah, I can give you some sense, and maybe Eric can jump in with a little more color.

Tejas Savant: Hey, guys, can you hear me? Okay. Yeah. Yeah.

Speaker Change: Okay, perfect

Speaker Change: All right, so.

Aaron Freidin: Aaron, could you just give us a better sense for the where the largest cost saves will come from? You know, I know you highlighted all the areas in the call, but just in terms of the magnitude of the contributions from each area, some color there would be great. Yeah, I can give you some sense, and then maybe Aaron can jump over a little more color. You know, so as we mentioned, there's $27 million we see a benefit in 2024, and overall we expect to get 2025 down to a cash burn of $325 million. You know, that's going to come from about a 30% reduction in both existing as well as planned requisition for 2024, but you know, existing headcount and planned wrecks.

Tejas Savant: A quick follow-up there on Kyle's question, Aaron, could you just give us a better sense for where the largest cost saves will come from? You know, I know you highlighted all the areas in the call, but just in terms of the magnitude of the contributions from each area, some color there would be great.

Unknown Executive: 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, you may unmute your audio and ask your question. As a reminder, we are allowing and list one question and one related follow-up today. We will wait one moment to allow the queue to fall. Thank you.

Aaron Frieden: You know, as we mentioned, there's $27 million we see in benefits in 2024, and overall, we expect to get 2025 down to a cash burn of $325 million. You know, that's going to come from about a 30% reduction in both existing as well as planned requisitions for 2024, but, you know, existing headcount and planned recs. Importantly, we're rolling off some of the major moves we've already done in terms of, you know, the NHS gallery study. We announced in July that we had finished our third year of study visits.

Aaron Frieden: Yeah, I can give you some sense and then maybe Erin can jump in with a little more color.

Erin: You know so as we mentioned there's 27 million dollars we see a benefit in 2024.

Erin: And overall, we expect to get 2025 down to a cash burn of $325 million. That's going to come from about a 30% reduction in both existing as well as planned requisitions for 2024, but existing headcount and planned RECs.

Robert Ragusa: You know, importantly, we're rolling off some of the major moves we've already done in terms of, you know, the NHS gallery study we announced in July that had finished our third year of study visits. And so we're doing the follow-up now on that. Similarly with Pathfinder 2, we completed enrollment of 35,000 people in Pathfinder 2, and so we're in the follow-up stage of that. We're finishing up an updated version of our gallery assay, which is really going to drive lower, lower ongoing COGS at scale. Some of the activities we're centralizing are Cleo Lab that's currently in Menlo Park and research trying to into Research Triangle Park where we have a significant facility there already at RTP.

Robert Ragusa: Our first question is from Pyle Nixon at Canacol, please unmute yourself and begin with your question. Hey guys, thanks for the questions and thanks for the miss update Paul. I guess there hasn't been a multi-cancer detection test like this scaled in the past and now you're getting cash burned down to levels of other precision college companies. What gives you confidence that this level of investment is enough to commercial service products? Pyle, thanks for the question.

Erin: You know importantly we're rolling off some of the major moves. We've already done in terms of

Speaker Change: You know, the NHS gallery study, we announced in July that that had finished our third year of study visits, and so we're doing the follow-up now on that. Similarly, with Pathfinder 2, we completed enrollment of 35,000 people in Pathfinder 2, and so we're in the follow-up stage of that.

Aaron Frieden: And so we're doing the follow up now on that. Similarly, with Pathfinder 2, we completed enrollment of 35,000 people in Pathfinder 2, and so we're in the follow up stage of that. We're finishing up an updated version of our gallery assay, which is really going to drive lower ongoing COGS at scale. Some of the activities, we're centralizing our CLIA lab that's currently in Menlo Park and Research Triangle Park into Research Triangle Park, where we have a significant facility there already at RTP.

Speaker Change: We're finishing up an updated version of our gallery assay, which is really going to drive lower ongoing COGS at scale.

Speaker Change: Some of the activities, we're centralizing our CLIA lab that's currently in Menlo Park and into Research Triangle Park where we have a significant facility there already at RTP.

Robert Ragusa: We've looked really carefully at our portfolio and recognized that by focusing on end-setting and getting to the key inflection points, particularly FDA approval of our PMA and then on the path to broad reimbursement is really critical for us. That's what a lot of the changes were driven by. We've did a very careful review of what it takes to get there. We're quite comfortable that we have the resources aligned to be able to go down that pathway successfully.

Robert Ragusa: And then the reductions in R&D are primarily focused on our DAC and MRD programs where, again, we think we have, you know, excellent technology that has a lot of application, but we're going to pause those for the moment in order to, you know, conserve resources down the commercial side where we've, you know, spent a lot of time over the last three years really understanding where we can be the most effective and efficient in our commercial efforts. And so we're going to use those learnings and really focus on, I'm really the most productive areas of commercial to be able to continue to drive sales. As Aaron mentioned, you know, probably had a more moderated pace because we think in a free reimbursement market, you know, this is more of an investment phase and getting ready for, you know, for that broad reimbursement element.

Aaron Frieden: And then the reductions in R&D are primarily focused on our DAC and MRD programs, where again we think we have excellent technology that has a lot of application, but we're going to pause those for the moment in order to conserve resources. Now on the commercial side, where we've spent a lot of time over the last three years really understanding where we can be the most effective and efficient in our commercial efforts. And so we're gonna use those learnings and really focus on the most productive areas of commercial to be able to continue to drive sales.

Speaker Change: And then the reductions in R&D are primarily focused on our DAC and MRD programs, where again we think we have, you know, excellent technology that has a lot of application, but we're going to pause those for the moment in order to, you know, just conserve resources.

Speaker Change: Now the commercial side where we've you know We spent a lot of time over the last three years really understanding where we can be the most effective and efficient

Speaker Change: in our commercial efforts.

Speaker Change: And so we're going to use those learnings and really focus on really the most productive areas of commercial to be able to continue to drive sales. As Aaron mentioned, probably at a more moderated pace.

Aaron Frieden: As Erin mentioned, probably at a more moderated pace because we think in a pre-reimbursement market, this is more of an investment phase and getting ready for that broad reimbursement element. And then, similarly, we're gonna look at G&A reductions that will be really in line with the other deductions across the organization to be just well balanced with that. Got it. That's helpful. Yeah, sorry. Go ahead. No, I think we're good.

Robert Ragusa: In that area around M-set, we actually made relatively few changes. We're staying consistent on our timeline. We're saying this is on the effort that we're applying to that area. It's really in other areas around DAC, M-set and some of the commercial elements that we pulled back from. We're talking about those helpful. Thanks again. Sorry for coming you off. Just related follow up. How will these cost products be phased in? I understand you're kind of implementing this now, I guess, but it's kind of mid-year, so I just curious about this and how it faces into the burn targets for next year.

Aaron Frieden: Because we think in a pre-reimbursement market, you know, this is more of an investment phase and getting ready for, you know, for that broad reimbursement element.

Aaron Freidin: And then similarly, we're going to look at GNA reductions that will be really in line with the other reductions across the organization to be just well, well balanced with that. Got it.

Aaron Frieden: And then, similarly, we're going to look at GNA reductions that will be really in line with the other reductions across the organization to be just well-balanced with that.

Aaron Freidin: Aaron, sorry, go ahead. No, I think we're good. Okay, all right, great.

Aaron Frieden: Got it. That's helpful. Yeah, Aaron. Sorry. Go ahead. Aaron, are you good? No, I think we're good.

Tejas Savant: Okay, all right, great. My second question was really around sort of just a progress update on the Gallery 2.0 launch and what drives your confidence that, you know, that's going to be a narrower panel so that it'll be non-inferior to the current version. Could you talk a little bit about when we could see the bridging study commence and then read out how big that trial needs to be since, ultimately, that's the PMA version that goes into FDA, and the NHS and Pathfinder trials are on the older version. So any color around that would be great.

Tejas Savant: My second question was really around sort of just a progress update on the Gallery 2.0 launch. And what drives your confidence that, you know, that's going to be a narrower panel so that that'll be non-inferior to the current version? Could you talk a little bit about when we could see the bridging study comments and then read out how big does that trial need to be? Since ultimately, that's the PMA version that goes into FDA, and the NHS and Pathfinder Trials are on the older versions. So any color around that would be great. Thank you. Yeah, no great question.

Speaker Change: Okay, all right, great. My second question was really around sort of just a progress update on the Gallery 2.0 launch and what drives your confidence that, you know, that's gonna be a narrower panel so that that'll be non-inferior to the current version. Could you talk a little bit about when we could see the bridging study commence and then read out how big does that trial need to be? Since ultimately that's the PMA version that goes into FDA and the NHS and Pathfinder trials are on the older version. So any color around that would be great. Thank you.

Robert Ragusa: When will MRD and DAC investments come back and how important are those still for the companies like long-long term growth profile? The actions will occur immediately. We're taking MRD and DAC. We believe we have great opportunities in both of those. We think our methylation technology is very well suited to those. On the precision oncology side, we're continuing supporting our biopharmal partners in that. That work will continue on the pure DAC and MRD work, though, we're causing future developments in those areas. We haven't set a timeline for reinvesting in those areas at this point. Again, because the focus is really to drive and set through the key inflection point.

Tejas Savant: Thank you. Yeah, no, great question. So we've clearly been doing a lot of work on our PMA and on the PMA version of the test. Another number of great elements, one is scalability.

Robert Ragusa: You know, so we've clearly been doing a lot of work on our PMA and on the PMA version of the test. Another number of great elements. One is, you know, the scalability. We recognize that, you know, gallery is really geared for population scale testing. And so we wanted to make sure both the cost structure as well as a scalability. We're set for population scale, so spend a lot of time and effort getting that piece in place.

Speaker Change: Yeah, no, great question. So we've clearly been doing a lot of work on our PMA and on the PMA version of the test.

Bob Ragusa: We recognize that Gallery is really geared for population scale testing, and so we wanted to make sure both the cost structure as well as the scalability were set up for population scale. So we spent a lot of time and effort getting that piece in place.

Speaker Change: Another number of great elements. One is, you know, the scalability. We recognize that, you know, gallery is really geared for population scale testing. And so we wanted to make sure both the cost structure as well as the scalability were set for population scale. So.

Joshua Offman: And then, maybe Josh, if you want to talk about the timeline and progression of the studies. Sure, I think one of the benefits of being in the market has been the ability to collect a lot of real-world data, which has really helped us train for the new version of the assay and gives us a lot of confidence in our ability to produce a scalable version of our assay, as Bob said, with comparable performance to our existing assay with a smaller panel, as described on our Capital Markets Day. So I think that we have great confidence right now that we're gonna be able to get that next version solidified and out.

Dr. Joshua Ahmed: And then maybe Josh, if you want to talk about the timeline and progression of the studies. Sure, I think, you know, one of the benefits of being in the market has been the ability to collect a lot of real world data, which has really helped us train for the new version of the assay and gives us a lot of confidence in our ability to produce a scalable version of our assays. As Bob said, with comparable performance to our existing assay with a smaller panel, as has been described on our Capital Markets Day. So I think that we have great confidence right now that we're going to be able to get that next version, you know, solidified and out as it relates to the FDA and bridging studies.

Josh: spent a lot of time and effort getting that piece in place, and then maybe, Josh, if you want to talk about the timeline and progression of the studies. Sure, I think, you know, one of the benefits of being in the market has been the ability to collect a lot of real-world data, which has really helped us

Robert Ragusa: The next question is from Tejas Savant at Morgan Stanley. Please unmute yourself and begin with your question. Hey guys, can you hear me okay? Yeah, yeah. Okay, perfect. All right, so a quick follow up there on Kyle's question. Aaron, could you just give us a better sense for the where the largest cost saves will come from? You know, I know you highlighted all the areas in the call, but just in terms of the magnitude of the contributions from each area, some color there would be great.

Josh: train.

Josh: for the new version of the assay and gives us a lot of confidence in our ability to produce a scalable version of our assay, as Bob said, with comparable performance to our existing assay with a smaller panel, as has been described on our Capital Markets Day.

Josh: So I think that we have great confidence right now that we're going to be able to get that next version, you know, solidified and out.

Joshua Offman: As it relates to the FDA and bridging studies, those are ongoing discussions with the FDA under our breakthrough designation. We're obviously working through our clinical validation plan with the FDA. And we believe we're gonna be able to complete our filing in the first half of 26 with data from our registrational studies, including bridging to the new version. Got it. That's helpful. Thanks, guys. I appreciate it. And our final question is from Sung Jin Nam at Scotia Bank. Please unmute yourself and begin with your question.

Tejas Savant: Those are ongoing discussions with the FDA under our breakthrough designation. We've obviously been working through our clinical validation plan with the FDA, and we're, you know, we believe we're going to be able to complete our filing in the first half of '26 with data from our federal registration studies, including, including bridging to the new version. Got it. That's helpful. Thanks, guys. Appreciate it.

Speaker Change: as it relates to the FDA and bridging studies.

Speaker Change: Those are ongoing discussions with the FDA under our breakthrough designation.

Speaker Change: We're obviously working through our clinical validation plan with the FDA, and we believe we're going to be able to complete our filing in the first half of 26 with data from our registrational studies, including bridging to the new version.

Robert Ragusa: Yeah, I can give you some sense and then maybe Aaron can jump over a little more color. You know, so as we mentioned, there's $27 million we see a benefit in 2024 and overall we expect to get 2025 down to a cash burn of $325 million. You know, that's going to come from about a 30% reduction in both existing as well as planned requisition for 2024, but you know, existing headcount and planned wrecks.

Speaker Change: Got it. That's helpful. Thanks guys. Appreciate it.

Song Janam: And our final question is from Song Janam at Scotia Bank.

Speaker Change: And our final question is from Sun Janam at Scotia Bank. Please unmute yourself and begin with your question.

Song Janam: Please unmute yourself and begin with a question. Hi, thanks for taking my questions. Just a couple of clarification questions for me. For the REACH study, looks like the primary endpoint is reduction in stage four.

Operator: Hi, thanks for taking my questions; just a couple of clarification questions for me about the Reach study, it looks like the primary endpoint is reduction in stage four cancers, and, Just to clarify, would that be sufficient for Medicare to cover the assay following FDA clearance? And also, could you define or, you know, could you maybe give us a sense of how you define a true positive test? Would that be a positive test that's confirmed within one year of the test implementation? Josh, do you want to take those?

Speaker Change: [inaudible]

Sun Janam: Hi, thanks for taking my questions. Just a couple of clarification questions for me. For the REACH study, it looks like the primary endpoint is reduction in stage 4 cancers and

Robert Ragusa: You know, importantly, we're rolling off some of the major moves we've already done in terms of, you know, the NHS gallery study we announced in July that that had finished our third year of study visits. And so we're doing the follow up now on that. Similarly with Pathfinder 2, we completed enrollment of 35,000 people in Pathfinder 2 and so we're in the follow up stage of that. We're finishing up an updated version of our gallery assay, which is really going to drive lower, lower ongoing cogs at scale.

Dr. Joshua Ahmed: Cancer, cancers and just to clarify, would that be sufficient for Medicare to cover the assay following FDA clearance? And also, could you define or, you know, could you maybe give us a sense of how you define a true positive test, would that be a positive test that's confirmed within one year of the test implementation. Josh, do you want to take those? Sure. Good question. So, you know, the REACH study, as you said, is a real-world evidence study of 50,000 Medicare beneficiaries tested for three consecutive years and a synthetic control that will be deriving from EMRs of health systems. The primary endpoint, as you said, is an absolute reduction in lead stage cancer.

Speaker Change: Just to clarify, would that be sufficient for Medicare to cover the assay following FDA clearance? And also, could you define or, you know, could you maybe

Speaker Change: Give us a sense of how you define a a true positive test. Would that be a positive test? That's confirmed within one year of the test implementation

Robert Ragusa: Some of the activities we're centralizing are Cleo Lab that's currently in Menlo Park and research trying to into research triangle park where we have a significant facility there already at RTP. And then the reductions in R&D are primarily focused on our DAC and MRD programs where, again, we think we have, you know, excellent technology that has a lot of application, but we're going to pause those for the moment in order to, you know, conserve resources down the commercial side where we've, you know, we've spent a lot of time where the last three years really understanding where we can be the most effective and efficient in our commercial efforts.

Joshua Offman: Sure. That's a good question. So, you know, the REACH study, as you said, is a real-world evidence study of 50,000 Medicare beneficiaries tested for three consecutive years and a synthetic control that will be derived from EMRs of health systems. The primary endpoint, as you said, is an absolute reduction in late-stage cancer. This is a post-approval study with the FDA, so it will really be used to supplement the data that we've submitted as part of our PMA. So there's no, you know, kind of registrational endpoint.

Speaker Change: Josh, you want to take those? Sure. Good question. So, you know, the REACH study, as you said, is a real-world evidence study.

Josh: 50,000 Medicare beneficiaries tested for three consecutive years.

Speaker Change: and a synthetic control that will be deriving from EMRs of health systems.

Speaker Change: The primary endpoint, as you said, is an absolute reduction in late-stage.

Dr. Joshua Ahmed: This is a post-approval study with the FDA. So it will really be used to supplement the data that we've submitted as part of our PMA. So there's no, you know, kind of registrational endpoint. As it relates to Medicare coverage, you know, first Medicare has to have the authority to provide coverage for gallery, and there's obviously ongoing effort by stakeholders in Washington DC to ensure that legislation is passed to make that happen. And if that happens upon FDA approval, CMS will then undertake a national coverage analysis. And these data both will have a great deal of performance data in the Medicare beneficiaries.

Speaker Change: cancer. This is a post-approval study.

Speaker Change: with the FDA, so it will really be used to supplement.

Speaker Change: the data that we've submitted as part of our PMA. So, there's no, you know, kind of registrational endpoint.

Robert Ragusa: And so we're going to use those learnings and really focus on, I'm really the most productive areas of commercial to be able to continue to drive sales, as Aaron mentioned, you know, probably had a more moderated pace because we think in a free reimbursement market, you know, this is more of an investment phase and getting ready for, you know, for that broad reimbursement element. And then similarly, we're going to look at GNA reductions that will be really in line with the other reductions across the organization to be just well, well balanced with that. Got it. Aaron, sorry, go ahead. No, I think we're good. Okay, all right, great.

Joshua Offman: As it relates to Medicare coverage, you know, first, Medicare has to have the authority to provide coverage for GALORE, and there's obviously an ongoing effort by stakeholders in Washington, D.C., to ensure that legislation is passed to make that happen, and if that happens, upon FDA approval, CMS will then undertake a national coverage analysis, and these data both will have a great deal of performance data on Medicare beneficiaries, it will have safety data on Medicare And so we believe that will be really compelling and sufficient for CMS to make that determination about coverage.

Speaker Change: As it relates to Medicare coverage.

Speaker Change: You know, first, Medicare has to have the authority.

Speaker Change: to provide coverage for gallery and there's obviously ongoing effort by stakeholders in Washington, D.C.

Speaker Change: to ensure that legislation is passed to make that happen.

Speaker Change: And if that happens, upon FDA approval, CMS will then undertake a national coverage analysis. And these data both will have...

Dr. Joshua Ahmed: It will have safety data in the Medicare beneficiaries, and it will have clinical utility data in the Medicare population. And so we believe that will be really compelling and sufficient for CMS to make that determination about coverage.

Speaker Change: a great deal of performance data in the Medicare beneficiaries, it will have safety data in the Medicare beneficiaries, and it will have clinical utility data in the Medicare population. So we believe that will be really compelling and sufficient for CMS to make that determination about coverage.

Robert Ragusa: My second question was really around sort of just a progress update on the Gallery 2.0 launch. And what drives your confidence that, you know, that's going to be a narrower panel so that that'll be non-inferior to the current version? Could you talk a little bit about when we could see the bridging study comments and then read out how big does that trial need to be? Since ultimately, that's the PMA version that goes into FDA and the NHS and Pathfinder Trials are on the older versions.

Song Janam: Got it. That's helpful.

Joshua Offman: Got it. That's helpful. And then just on the portfolio rationalization, the MRD, you know, I think that rationale makes sense. But for the DAC, are the existing studies not that much leverageable for this particular assay, given you're looking for symptomatic patients? And then related to that, could symptomatic patients still order the test, the ordering gallery, with a prescription, obviously, from you guys? Obviously, they might have to, you know, pay out of pocket, but would that still be a possibility?

Dr. Joshua Ahmed: And then just on the portfolio rationalization, the MRD, you know, I think that rationale may sense, but for the DAC, are the existing studies not that much leverageable for this particular aspect given you're looking for symptom adaptations. And then related to that, could symptom adaptations, could they still order the test order gallery with a prescription obviously from you guys? Obviously, might have to pay out of pocket, but would that still be a possibility? Yeah, so we, you know, as you call, we published the simplified data and we presented that it was published in the last set.

Speaker Change: Got it. That's helpful. And then just on the portfolio rationalization, the MRD, you know, I think that rationale makes sense. But for the DAC, are the existing studies not that much leverageable for this particular assay, given you're looking for symptomatic patients? And then,

Robert Ragusa: So any color around that would be great. Thank you. Yeah, no great question. You know, so we've clearly been doing a lot of work on our, on our PMA and on the PMA version of the test. Another number of great elements. One is, you know, the scalability we recognize that, you know, gallery is really geared for population scale testing. And so we wanted to make sure both the cost structure as well as a scalability.

Speaker Change: Related to that, could symptomatic patients, could they still order the test, the order gallery with the prescription, obviously from you guys, obviously might have to pay out of pocket, but would that still be a possibility?

Bob Ragusa: Yeah, so we, you know, as you recall, we published the Simplify data, and we presented that, it was published in the Lancet, and really great results that show the power of a DAC-type product, and really strong positive predictive value and negative predictive value. So we feel very, very good about the technology, you know, and right now, we're really just looking at the level of investment required to bring that, you know, as a broad-scale product out onto the market. And so when we looked at the portfolio, again, you know, we chose to pause the DAC part of the portfolio, really in favor of pushing forward with MSED as the major focus.

Speaker Change: Yeah, so we, you know, as you recall, we published the simplified data and we presented that it was published in the Lancet and, you know, really great results and shows the power of a DAC type product.

Dr. Joshua Ahmed: And you know, really great results and shows the power of a DAC, DAC type product. And you know, with really strong both positive predictive value and negative predictive value. So we feel very, very good about the technology. You know, and right now it's really just looking at the level of investment required to bring that, you know, as a broad scale product out to the market.

Robert Ragusa: We're set for population scale, so spend a lot of time and effort getting that piece in place. And then maybe Josh, if you want to talk about the timeline and progression of the studies. Sure, I think, you know, one of the benefits of being in the market has been the ability to collect a lot of real world data, which has really helped us train for the new version of the assay and gives us a lot of confidence and our ability to produce a scalable version of our assays.

Speaker Change: And, you know, with really strong, both positive predictive value and negative predictive value. So we feel very, very good about.

Speaker Change: The technology, you know, and right now it's really just looking at the level of investment required to bring that, you know, as a broad scale product out onto the market.

Song Janam: And so when we looked at the portfolio, again, you know, we chose to pause the DAC, the DAC part of the portfolio; you'll really in favor of pushing forward with them said as the major focus. Great. Thank you.

Speaker Change: And so when we looked at the portfolio, again, we chose to pause the DAC, the DAC part of the portfolio, really in favor of pushing forward with MSED as the major focus.

Robert Ragusa: As Bob said, with comparable performance to our existing assay with a smaller panel, as has been described on our capital markets day. So I think that we have great confidence right now that we're going to be able to to get that next version, you know, solidified and out as it relates to the FDA and bridging studies. Those are ongoing discussions with the the FDA under our breakthrough designation. We've obviously working through our clinical validation plan with the FDA and we're, you know, we believe we're going to be able to complete our filing in the first half of 26 with data from our federal registration studies, including, including bridging to the new version. Got it. That's helpful. Thanks guys. Appreciate it.

Operator: Great, thank you. Thank you. There are no further questions at this time. I will now turn the call back to Grail to close the remarks. I want to thank everyone for joining today's call.

Speaker Change: Great, thank you.

Operator: There are no further questions at this time.

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

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

Graille: I want to thank everyone for joining today's call.

Unknown Executive: And our final question is from Song Janam at Scotia Bank. Please unmute yourself and begin with a question. Hi, thanks for taking my questions. Just a couple of clarification questions for me. For the reach study looks like the primary endpoint is reduction in stage four.

Joshua Ahmed: Cancer, cancers and just to clarify, would that would that be sufficient for Medicare to cover the assay following FDA clearance and also could you define or, you know, could you maybe give us a sense of how you define a true positive test, would that be a positive test that's confirmed within one year of the test implementation. Josh, you want to take those? Sure. Good question. So, you know, the reach study, as you said, is a real world evidence study of 50,000 Medicare beneficiaries tested for three consecutive years and a synthetic control that will be deriving from EMRs of health systems.

Joshua Ahmed: The primary endpoint, as you said, is an absolute reduction in lead stage cancer. This is a post approval study with the FDA. So it will really be used to supplement the data that we've submitted as part of our PMA. So there's no, you know, kind of registrational endpoint. As it relates to Medicare coverage, you know, first Medicare has to have the authority to provide coverage for gallery and there's obviously ongoing effort by stakeholders in Washington DC to ensure that legislation is passed to make that happen.

Joshua Ahmed: And if that happens upon FDA approval, CMS will then undertake a national coverage analysis. And these data both will have a great deal of performance data in the Medicare beneficiaries. It will have safety data in the Medicare beneficiaries and it will have clinical utility data in the Medicare population. And so we believe that will be really compelling and sufficient for CMS to make that determination about coverage. Got it. That's helpful.

Joshua Ahmed: And then just on the portfolio rationalization, the MRD, you know, I think that rationale may sense, but for the for the DAC, are the existing studies not that much leverageable for this particular aspect given you're looking for symptom adaptations. And then related to that could symptom adaptations, could they still order the test order gallery with a prescription obviously from you guys obviously might have to pay out a pocket, but would that still be a possibility?

Joshua Ahmed: Yeah, so we, you know, as you call, we published the simplified data and we presented that it was published in the last set. And you know, really great results and shows the power of a DAC, DAC type product. And you know, with really strong both positive predictive value and negative predictive value. So we feel very, very good about the technology, you know, and right now it's really just looking at the level of investment required to bring that, you know, as a broad scale product out to the market.

Joshua Ahmed: And so when we looked at the portfolio, again, you know, we chose to pause the DAC, the DAC part of the portfolio, you'll really in favor of pushing forward with them said as the as the major focus. Great. Thank you. There are no further questions at this time.

Unknown Executive: I will now turn the call back to Grail for closing remarks.

Unknown Executive: I want to thank everyone for joining today's call.