Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $35.5 million, an increase of $3.5 million or 11% compared to Q2 2024 [22] - Screening revenue was $34.4 million, up 22% compared to the same period in 2024 [24] - Net loss for the quarter was $114 million, an improvement of 93% compared to Q2 2024 [26] - Non-GAAP adjusted gross profit for Q2 2025 was $16.1 million, an increase of $100,000 or 1% compared to Q2 2024 [26] - Cash position at the end of the quarter was $606.1 million, with updated guidance for cash burn in 2025 reduced to no more than $310 million [26] Business Line Data and Key Metrics Changes - More than 45,000 Gallery tests were sold in Q2 2025, with over 370,000 tests prescribed since the commercial launch in 2021 [7][22] - U.S. Gallery revenue was $34.2 million, up 21% compared to Q2 2024, with expectations of 20% to 30% growth for the full year [24][25] - Repeat test volumes have trended higher, with over 25% of Gallery's volume being repeat testing [23] Market Data and Key Metrics Changes - The company has established partnerships with healthcare systems, including Rush University System for Health, to increase availability of the Gallery test [7] - Integration of Gallery into the Quest diagnostic test ordering platform has shown promising growth, with 7% of orders coming through this platform in Q2 [61] Company Strategy and Development Direction - The company is focused on seeking FDA approval for Gallery and pursuing broad reimbursement [28] - Plans to submit detailed results from the Pathfinder two study for presentation at the ESMO Congress in October 2025 [28] - The company aims to achieve major clinical and regulatory milestones, with cash runway extending into 2028 [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for Gallery, both from new and returning patients [28] - The company is encouraged by the performance metrics from the Pathfinder studies, indicating improved cancer detection rates and positive predictive values [14][17] - Management highlighted the importance of clinical validation in the intended use population for the success of multi-cancer early detection tests [12][42] Other Important Information - The company is working to address increased turnaround times and higher reprocessing costs associated with the new version of Gallery [9] - The upcoming Analyst Day in November 2025 will feature key study results and clinical findings [9][28] Q&A Session Summary Question: Can you comment on Q2 free cash burn and dynamics impacting cash burn in the second half of 2025? - Management indicated that cash burn for the first half was about $160 million and expects it to decrease in the second half due to increased revenue and volume [34][35] Question: Do you need full longitudinal clinical utility data for PMA submission? - Management clarified that the FDA focuses on clinical validation rather than clinical utility for approvals [41][42] Question: How is the integration with Quest performing? - Management reported that about 500 healthcare professionals have ordered the Gallery test via Quest, with a 7% order rate through this platform in Q2 [61] Question: What are the expectations for repeat testing rates? - Management expressed satisfaction with the increase in repeat testing rates, which rose to over 25% in Q2 [65]

Summary of GRAIL (GRAL) 2025 Conference Call Company Overview - GRAIL is focused on early cancer detection, aiming to identify cancers when they are most treatable [2][3] - The company has developed the Gallery test, a multi-cancer early detection test designed for population-scale screening [3][4] Core Industry Insights - Current cancer screening methods are limited, primarily testing for single cancers, leading to late-stage cancer diagnoses [3][12] - GRAIL's Gallery test is positioned to address this gap by detecting multiple cancers early, significantly improving survival rates [12][13] Key Financial Highlights - Total revenue for Q1 2025 was $32 million, a 19% increase year-on-year [9] - U.S. Gallery revenue was $29 million, up 22%, aligning with the company's guidance for the year [9] - Cash balance stands at $678 million, providing operational runway into 2028 [10] Commercial Developments - Over 325,000 Gallery tests sold through March 2025, with strong commercial momentum noted [4][22] - Partnerships with Quest Diagnostics and Athena Health have been established to enhance provider access to the Gallery test [5][24] - The U.S. military's TRICARE program has added the Gallery test as a covered benefit for eligible patients [6] Clinical Evidence and Research - GRAIL has conducted over 640,000 Gallery tests across commercial and clinical applications [5] - The Gallery test has shown a positive predictive value (PPV) of 43%, significantly higher than leading single cancer screening tests [16][17] - The test's specificity is reported at 99.5%, with high accuracy in determining the cancer signal's origin [19] Market Opportunity - The total addressable market (TAM) in the U.S. is over 100 million individuals, expanding to 160 million when including the EU and nearly 50 million in Japan [21][22] - The company aims to capture a significant share of the market by providing broad access to multi-cancer early detection [26] Future Outlook - GRAIL is focused on obtaining FDA approval and broad reimbursement for the Gallery test, with significant investments in infrastructure and operations [6][10] - Upcoming milestones include the readout of foundational data from the Pathfinder study and final clinical utility data from the NHS Gallery study expected in mid-2026 [28] Additional Insights - Market research indicates a strong consumer desire for innovative cancer screening options, with a majority of adults wanting early detection [8] - The company is committed to reducing costs per test as it scales operations, which will enhance accessibility [10][26] - GRAIL's long-term vision includes expanding its capabilities to meet the needs of individuals at elevated risk of cancer [26][27]

Financial Data and Key Metrics Changes - First quarter revenue reached $31.8 million, an increase of $5.1 million or 19% compared to the first quarter of 2024 [26] - Screening revenue was $29.1 million, up 24% year-over-year, while development service revenue was $2.7 million [27] - Net loss for the quarter was $106.2 million, an improvement of 51% compared to the same quarter last year [29] - Non-GAAP adjusted gross profit was $14.3 million, a 19% increase from the previous year [29] - Cash position at the end of the quarter was $677.9 million, with a projected cash burn of no more than $320 million for the full year 2025 [29][30] Business Line Data and Key Metrics Changes - The company sold over 37,000 Gallery tests in the first quarter, with repeat test volumes exceeding 20% [27][28] - The rollout of an enhanced version of the Gallery test began in Q4 of the previous year, aimed at improving scalability and reducing costs [9] Market Data and Key Metrics Changes - The company has prescribed over 325,000 Gallery tests since its commercial launch in 2021, with more than 14,000 healthcare providers involved [8] - The integration of Gallery within athenahealth's EHR platform is expected to streamline the ordering process for over 60,000 US providers [9] Company Strategy and Development Direction - The company aims to advance its Gallery test through key clinical and regulatory milestones to unlock broader access [5] - A new educational campaign called "Generation Possible" has been launched to raise public awareness about multi-cancer early detection [10] - The company is focused on maintaining disciplined cost management while pursuing commercial growth in 2025 [5][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for the Gallery test and the progress towards FDA approval and broad reimbursement [31] - The company is on track for continued commercial growth, with expected volume growth from TRICARE coverage and integration with Quest Diagnostics [9][31] - Management highlighted the importance of annual screening with the Gallery test to reduce the risk of late-stage cancer diagnosis [21] Other Important Information - The NHS Gallery trial is the largest randomized controlled trial of any multi-cancer early detection test, with results expected in mid-2026 [14][15] - The company plans to submit data from the NHS Gallery trial and other studies as part of its premarket approval application in the first half of 2026 [25] Q&A Session Summary Question: Can you quantify the short-term variable cost improvements from the new version of Gallery? - Management indicated that margins are expected to improve over the year as the transition to the new version is completed [35] Question: How have Quest and TRICARE approvals played out in Q1? - Management noted early positive ordering trends from Quest providers and ongoing work with TRICARE contractors [36][37] Question: What is the cash burn trajectory for the remainder of the year? - The company reported a cash burn of just under $90 million in Q1, with expectations to remain within the $320 million target for the year [42][43] Question: How does the NHS Gallery data impact future readouts? - Management emphasized that the first round of screening results may differ from subsequent rounds, with final results expected in mid-2026 [50] Question: What is the rationale behind not raising additional funds at this time? - Management believes that achieving key milestones will derisk the business and create value, thus justifying the decision to wait [61][62]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $31.8 million, an increase of $5.1 million or 19% compared to Q1 2024 [26] - Screening revenue was $29.1 million, up 24% year-over-year, while development service revenue was $2.7 million [27] - Net loss for the quarter was $106.2 million, an improvement of 51% compared to Q1 2024 [29] - Non-GAAP adjusted gross profit for Q1 2025 was $14.3 million, an increase of $2.3 million or 19% year-over-year [29] - Cash position at the end of the quarter was $677.9 million, with a projected cash burn of no more than $320 million for the full year 2025 [29][30] Business Line Data and Key Metrics Changes - More than 37,000 Gallery tests were sold in Q1 2025, with repeat test volumes increasing over time, now accounting for over 20% of total volume [26][27] - The company has prescribed over 325,000 Gallery tests since its commercial launch in 2021 [7] Market Data and Key Metrics Changes - The company has launched Gallery commercially in Israel in partnership with OncoTest, with initial test orders being received [9] - The integration of Gallery within athenahealth's EHR platform is expected to streamline the ordering process for over 60,000 US providers [8] Company Strategy and Development Direction - The company aims to advance Gallery through key clinical and regulatory milestones to unlock broad access while managing costs [5] - A new educational campaign called "Generation Possible" has been initiated to raise public awareness of multi-cancer early detection [9] - The company is focused on achieving FDA approval for Gallery and pursuing broad reimbursement [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for Gallery and the progress towards major milestones, including TRICARE coverage and integration with Quest Diagnostics [31] - The company expects to share interim data from the PATHFINDER II study in late 2025 and complete its PMA submission to the FDA in the first half of 2026 [31] Other Important Information - The NHS Gallery trial is the largest randomized controlled trial of any multi-cancer early detection test, with results expected in mid-2026 [12][14] - The company has made significant investments to optimize technology and laboratory infrastructure, including the rollout of an enhanced version of the Gallery test [7] Q&A Session Summary Question: Can you quantify the expected short-term variable cost improvements from the new version of Gallery? - Management indicated that margins are expected to improve over the year as they transition to the new version [35][36] Question: How is the cash burn tracking towards the $320 million target? - The company burned just under $90 million in Q1, with expectations that cash burn will align with the target as margins improve [42][44] Question: What is the rationale behind not raising money to derisk the outlook? - Management believes that achieving major milestones will create value and that they have sufficient cash runway to reach these goals [62][66] Question: How are recent conversations with NHS progressing regarding Gallery commercialization? - Management stated they are in constant dialogue with NHS and that decisions on commercialization will wait for final results from the study [70][72]