GRAIL, Inc.

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 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 today are Bob Ragusa, our Chief Executive Officer, Aaron Frieden, our Chief Financial Officer, Dr. Joshua Offman, our President, and Sir Harpo Kumar, 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 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 Securities and Exchange Commission, including the Risk Factor section in Grail's most recently quarterly report on Form 10Q. 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 Braille'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. 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. 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 runway 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. 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. 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. 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. 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 have completed the final study visits for 140,000 participants in the NHS Gallery study and have completed the enrollment in the 35,000 participant 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. 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 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. Roehl is an established market leader in the field, and we are proud of the impact that gallery is having on patients' lives. Following a portfolio review, we are reprioritizing our resources on our core NSAID priorities and reduce overall spend as we progress towards completion of our registrational 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 readouts. As a result of focusing our resources on achieving broad gallery reimbursement in the U.S. and U.K., we are reducing existing headcount and planned 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 affairs 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 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 responsibilities. 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 programs. In addition, we are making reductions in G&A to reflect the focus on our MSED opportunity. We will continue to invest in our biopharmaceutical partnerships and are committed to working with our partners to leverage Braille's proprietary methylation technology in precision oncology applications. This restructure and result in staff reductions are difficult, and we are immensely grateful to our employees who've worked hard to enable Braille's success to date and helped transition MSED from an idea into a reality. We wish all of our impacted employees well. To discuss our second quarter financial results, I'll hand it over to Braille's Chief Financial Officer, Aaron Frieden.