GRAIL, Inc.

Good day, ladies and gentlemen, and welcome to the Grail Third Quarter 2024 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.

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

Good afternoon, everyone, and thank you for joining us to review results for the third quarter. We remain pleased with the demand for Gallery that we are seeing in the pre-reimbursement environment. Through September 30th of this year, more than 250,000 commercial Gallery tests have been prescribed by more than 12,000 healthcare providers since launch. Grail is an established market leader in the field, and we are proud of the demonstrated impact that Gallery is having on patients' lives. Gallery was designed for population scale and Grail continues to optimize our technology and laboratory infrastructure to enable future growth. At the end of this year, we will launch the next version of the Gallery test. With the new assay, we've integrated a significant level of automation among other efficiencies to support volume at scale and enable reductions in cost over time. Additionally, our large laboratory facility of approximately 200,000 square feet in Research Triangle Park, North Carolina, enables us to scale laboratory capacity substantially for multiple years of growth. We continue to present evidence demonstrating Gallery's performance at renowned medical conferences and publish the results in leading peer-reviewed publications. In September, JCO Precision Oncology published a sub-analysis from our CCGA and Pathfinder studies in prostate cancer. For prostate cancer in general, over-diagnosis of insulin cancers is a particular concern. The analysis demonstrated that when gallery-detected prostate cancer, most were high-grade and clinically significant and usually indicative of aggressive disease where additional diagnostic evaluation is necessary. These data, previously shared at AACR in March, build on earlier findings regarding galleries' preferential detection of aggressive, deadly cancers. This is important because any screening paradigm, when designed for population scale, in addition to standard of care of screening, should not exasperate overdiagnosis of indolent cancers. In October, Guerrero presented early results from the Reflection Real-World Evidence Study of Gallery at the Early Detection of Cancer Conference. In this study, a diverse population of approximately 2,800 veterans from the U.S. Department of Veterans Affairs sites with toxic exposure but with no symptoms suggestive of cancer were evaluated. Initial results show that among study participants, the veteran cohort had a cancer signal detection rate of 1.3% and a positive predictive value of 42.9%. More than half of the cases were identified at early stage of 1 to 3. To discuss our second quarter financial results, I'll turn it over to GRAIL's Chief Financial Officer, Aaron Frieden.