GRAIL remains focused on our mission to detect cancer early, when it can be cured.

Revenue for the first quarter of 2023, comprised of Galleri test sales and biopharmaceutical partnerships revenue, was $26.7 million. 

We continue to see uptake for Galleri in health systems, clinics and the employer and life insurance channels across the U.S. We surpassed 10,000 Galleri prescribers in early 2024, and we have completed more than 180,000 commercial Galleri tests cumulatively as of the end of March. With forward leaning payors and employers across a multitude of sectors, commercial engagements remains strong. 

Our registrational clinical studies are progressing. The NHS-Galleri study is anticipated to complete its third and final round of planned blood draws in July, and we have enrolled more than 30,000 participants in our PATHFINDER 2 study. Study results for NHS-Galleri are anticipated in 2026. Interim results from PATHFINDER 2 are expected in 2025 when we have a full year follow-up on the first 25,000 patients. Together, these studies are anticipated to include approximately 175,000 participants and support our PMA submission to the FDA. 

Additionally, the Galleri-Medicare study (REACH) will enroll 50,000 Medicare beneficiaries for three annual tests, evaluating the performance and clinical impact of Galleri compared to a matched synthetic control. This study is an important addition to our body of clinical and real-world evidence for multi-cancer early detection.

We continue to pursue potential applications for our technology in precision oncology settings and recently announced a novel risk-classification assay to be included in a lung cancer study in collaboration with AstraZeneca. Data evaluating our methylation technology’s capability in molecular subtyping were recently presented at the American Association for Cancer Research (AACR) Annual Meeting 2024. 

Recent Business Highlights

• In January, we and BeniComp, a health benefit manager, announced a new partnership to offer Galleri for employee health screening. Within the partnership, Galleri is available to eligible patients through BeniComp Select members.

• In February, we and Curative Insurance Company announced a partnership by which the Galleri test is available to insurance plan members. The Galleri test is part of the expansive list of benefit offerings available for $0 copay and $0 deductible on Curative’s health insurance plan.

• In March, we announced that a novel risk-classification test to inform risk prediction is being used in an AstraZeneca lung cancer study in Japan. The assay was developed by GRAIL using GRAIL’s proprietary methylation platform and has been validated for recurrence risk classification in newly diagnosed Stage I lung non small cell adenocarcinoma. Investigating the effectiveness of the GRAIL assay in this use case is part of a broad strategic collaboration with AstraZeneca announced in 2022 to develop and commercialize companion diagnostic assays for use with AstraZeneca’s therapies.

• In April, we presented new data highlighting the use of GRAIL’s targeted methylation platform in both early cancer detection and precision oncology applications at AACR 2024. In the MCED setting, we presented new findings in three oral presentations. 

• The first real-world evaluation of repeat Galleri testing: Data supporting the use of annual testing to potentially improve early detection of multiple cancer types, including those without United States Preventive Services Task Force (USPSTF) recommended screening
• Four-year overall survival analysis: Follow up data supporting the preferential detection of aggressive cancers with a methylation-based cfDNA platform like Galleri
• Prostate cancer sub-analysis: Data demonstrating the power of Galleri to preferentially detect high grade, clinically significant prostate cancer over indolent cases

In the precision oncology setting, we shared data illustrating the potential adaptability of our methylation platform in identifying cancer histological and molecular subtypes through blood samples.