GRAIL is pleased to report continued progress on our mission to detect cancer early when it can be cured. Galleri adoption continues to grow, with more than 125,000 commercial tests returned as of September 30, 2023. We continue to grow our commercial reach with a number of new partnerships, including a multi-state collaboration with HCA Healthcare. In addition, we have expanded a number of partnerships including a Point32Health expansion to offer Galleri to eligible members in employer-sponsored plans within the Mass General Brigham-affiliated provider network. 

Revenue in the third quarter of 2023, comprising Galleri test sales and biopharmaceutical business revenue, was $20.7 million.

Through collaborative commercial and research partnerships, we are building our clinical and real-world evidence base, furthering our innovative research, and working towards improving health equity. In August, we announced a research collaboration with Whitman-Walker Institute focused on community outreach strategies with groups historically underrepresented in clinical research and care. Along with our partners, we are committed to generating high quality evidence and have enrolled more than 300,000 individuals in our clinical research program. We recently published final results from the PATHFINDER study of GRAIL’s multi-cancer early detection (MCED) blood test in The Lancet. 

Recent Business Highlights

• In October, we published final results from the seminal PATHFINDER study of GRAIL’s MCED test in The Lancet. PATHFINDER results demonstrated that GRAIL’s MCED test identified many cancer types that do not currently have recommended screening tests; more than doubled the cancers detected in the population when added to standard of care screening; by predicting the location of the cancer signal, enabled a targeted and efficient cancer diagnostic evaluation, as directed by the CSO prediction; and supported diagnostic resolution for the majority of participants in less than three months.

• In October, GRAIL and HCA Healthcare, one of the nation’s leading healthcare providers, announced a strategic partnership introducing Galleri to eligible patients at select HCA Healthcare physician practices. As part of the initiative, Sarah Cannon, the Cancer Institute of HCA Healthcare, will leverage its nurse navigation program to support patients and providers through the diagnostic journey following a positive Galleri test result. HCA Healthcare is also participating across multiple sites in GRAIL’s ongoing interventional PATHFINDER 2 study. 

• In September, GRAIL and Point32Health announced an expansion to our existing pilot program for the Galleri test. The expansion enables Galleri access to the commercial health plan’s eligible members in employer-sponsored plans within the Mass General Brigham-affiliated provider network. As part of the program, Mass General Cancer Center’s Early Detection and Diagnostics Clinic is assessing eligible participants for cancer risk and offers the test for eligible members at no cost. 

• GRAIL continues to pursue partnerships to build awareness and improve equitable access to early cancer detection across communities. In August, we and Whitman-Walker Institute, a Federally Qualified Health Center and leader in LGBTQ health and policy, as well as the global non-profit Cancer Support Community, announced a research collaboration to evaluate established community outreach strategies. Outreach will be focused on groups that have been historically underrepresented in clinical research and care.

• In September, GRAIL was named to Fortune’s 2023 Change the World list. The annual Change the World list features companies addressing society’s biggest challenges – those who have had a positive social impact through activities within their core business. Companies are assessed on factors including measurable social impact, business results and innovation. GRAIL was recognized for its work to transform care across the cancer continuum and change the trajectory of cancer mortality. 

The European Commission’s Restorative Measures Decision

In October, the European Commission (EC) announced its adoption of the Restorative Measures decision, which requires GRAIL’s divestment from Illumina. The European Commission’s decision recognizes GRAIL’s role as a driving force behind multi-cancer early detection, and as mentioned in the European Commission’s press release, the European Commission is committed to ensuring that any divestment scenario supports GRAIL’s ongoing viability and competitiveness. 

As noted in Illumina’s press release, Illumina is committed to resolving all issues regarding GRAIL in a timely manner, with the objective of achieving the maximum value for shareholders and the best outcome for GRAIL. Illumina will have twelve months to divest GRAIL, with the potential for a three-month extension. In the instance of a capital markets transaction, Illumina must capitalize GRAIL at the time of the transaction with two-and-a-half years of funding based on GRAIL’s long-range plan. In the interim, we will continue to be held separate from Illumina with committed funding for GRAIL’s business. 

GRAIL remains focused on delivering high-quality Galleri test results to patients and support for their ordering physicians, advancing our commercial and research partnerships, building our clinical and real-world evidence base, and furthering our innovative research. We have continued to make significant progress as an organization while held separate from Illumina since 2021. Under GRAIL’s management team, we have:

• Deployed a multi-channel commercial strategy to drive Galleri adoption pre-reimbursement
• Established more than 100 commercial partnerships with health systems, employers, life insurance organizations and other stakeholders across the healthcare ecosystem in the U.S.
• Published the PATHFINDER and SYMPLIFY multi-cancer early detection studies in The Lancet and Lancet Oncology, respectively, and a comprehensive DNA methylation atlas in Nature
• Entered the third year of the 140,000+ participant NHS-Galleri trial. Subject to the interim results of the NHS-Galleri trial, the NHS may commence the commercial implementation of the test to an additional one million patients in England over two years
• Made progress in enrolling PATHFINDER 2 in the US 
• Continued to pursue our PMA application for Galleri with the U.S. FDA 
• Grown our biopharmaceutical precision oncology business, generating revenues from multiple partners and launching our Research Use Only solution 
• Received several high-profile national accolades, including recognition by Time and The Atlantic as a top breakthrough of 2022 and being named to the Fortune Change the World list in 2023