GRAIL, Inc.

Good day, ladies and gentlemen, and welcome to the Grail Second Quarter 2025 Earnings Call. At this time, all participants are in a listen-only mode. 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.

Thanks, Operator, and thanks, everyone, for joining us today. On the call are Bob Ragusa, our Chief Executive Officer, Aaron Frieden, our Chief Financial Officer, Dr. Joshua Offen, our President, Sir Harpal Kumar, our President, International Business and Biopharma, and Andy Partridge, our Chief Commercial Officer. We'll be making forward-looking statements on this call based on current expectations. It's our intent that all statements, other than the statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 as amended and Section 21 of the Securities Exchange Act of 1934 as amended. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and GRAIL assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that GRAIL follows with the SEC, including the risk factor section in GRAIL's most recent quarterly report on Form 10-Q. This call will also include a discussion of GAAP results in certain non-GAAP financial measures, including adjusted gross profit or loss, which are adjusted to exclude certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of gross financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website.

And with that, we turn to Bob. Thank you. Good afternoon, everyone. And thank you for joining us to review second quarter results. For nearly a decade, Grail has made key investments to advance our vision for population scale, multi-cancer early detection, and establish a durable advantage in a growing field. The timeframe to establish evidence in this space is long, and we are setting the evidence bar high. We started population scale clinical studies years ago, and now house several years of follow-up data. Our pivotal implementation and clinical utility studies in the intended use population are beginning to read out, and we are delighted to see results not only confirm earlier studies, but actually improve certain performance measures as we evaluate gallery in larger populations. We plan to submit detailed results from the pre-specified analysis of the first 25,000 patients in our Registrational Pathfinder 2 study for presentation at the ESMO Congress 2025 in October. As a reminder, we announced positive top-line performance and safety results from this dataset in June. namely that we observed substantially greater additional cancer detection and a substantially higher positive predictive value in Pathfinder 2 compared to the first Pathfinder study. And Josh will describe these results further shortly. We've been working with advocates and stakeholders to deploy MSED, and we are finding aggressive cancers in real-world commercial setting, many of which are in early stages. Gallery test orders continue to grow at a strong clip with more than 45,000 gallery commercial tests sold in the second quarter. As of June 30th, more than 370,000 gallery tests have been prescribed by more than 15,000 healthcare providers since we launched gallery commercially in 2021. We continue to drive provider and patient awareness of the MSED opportunity and gallery's ability to detect cancer earlier when it is more amenable to treatment. Grail has established several partnerships with healthcare systems to make Gallery available to patients, and we were very pleased to add Rush University System for Health in July. Rush is one of the largest health systems in the U.S. and the first in the Chicago area market to offer the Gallery test. Additionally, we recently entered into a new collaboration with Everly Well, a digital health company pioneering in next generation of biomarker intelligence, and Gallery is now available for request directly on Everly Well's website via prescription. We remain on track for continued commercial growth in 2025, We are also encouraged by increasing gallery volume via the Quest diagnostic test ordering platform at mid-year, which follows gallery integration into the platform earlier in 2025. In late 2024, we began the use of a new version of gallery for which we were submitting our PMA in commercial channels. This new version incorporates an industrial scale platform with significant automation intended to enable us to scale more efficiently with future demand. As a result of the scale and complexity of the system, there are certain new processes to sort through with a large-scale rollout. For example, for a small proportion of samples, we've experienced increased turnaround times with higher reprocessing costs. We are now working to implement the fix to this issue. Before I hand it over to Josh, I'd like to notify the group that we will host our 2025 Analyst Day in November. Feature speeches will detail key study results and clinical surveillance findings. Frame our upcoming longitudinal clinical utility data and describe firsthand customer experience with Gallery. Event details will be announced at a later date. Josh, please go ahead.