Original from: GRAIL
GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the first quarter 2025.
Total revenue in the first quarter was $31.8 million, representing 19% growth year over year, and Galleri revenue was $29.1 million, representing 24% growth year over year. U.S. Galleri revenue was $28.7 million, representing 22% growth year over year. Net loss for the quarter was $106.2 million, which includes amortization of Illumina acquisition-related intangible items of $34.6 million. Gross loss was $19.9 million. Adjusted gross profit was $14.3 million, and adjusted EBITDA was $(98.7) million.1
“We are pleased with the continued U.S. commercial growth of Galleri, with more than 37,000 Galleri tests completed in the first quarter of 2025, as well as recent steps to streamline the test ordering process and increase test access,” said Bob Ragusa, Chief Executive Officer at GRAIL. “We remain focused on developing the market for population scale multi-cancer early detection, advancing Galleri to unlock broad access, and cost efficiency.”
For the three months ended March 31, 2025, as compared to the three months ended March 31, 2024, GRAIL reported:
· Revenue: Total revenue, comprised of screening and development services revenue, was $31.8 million, an increase of $5.1 million or 19%.
· Net loss: Net loss was $106.2 million, an improvement of $112.7 million or 51%.
· Gross loss: Gross loss was $19.9 million, an improvement of $2.0 million or 9%.
· Adjusted gross profit1: Adjusted gross profit was $14.3 million, an increase of $2.3 million or 19%.
· Adjusted EBITDA1: Adjusted EBITDA was $(98.7) million, an improvement of $53.2 million or 35%.
Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled $677.9 million as of March 31, 2025.
NHS-Galleri Trial Update
GRAIL recently completed a review of Galleri test performance results in the intervention arm from the prevalent screening round of the registrational NHS-Galleri trial. The prevalent screening round is the first round of blood draws (of the three total blood draw rounds in the trial) with one year of follow up.
Data from the prevalent screening round showed a substantially higher positive predictive value (PPV) than that observed in the PATHFINDER study, which was previously published in The Lancet. Cancer signal of origin (CSO) accuracy and specificity were consistent with that observed in the PATHFINDER study. In PATHFINDER, Galleri demonstrated a PPV of 43%, CSO accuracy of 88%, and specificity of 99.5%. There were no serious safety concerns in the NHS-Galleri prevalent screening round, also consistent with the PATHFINDER study.
“We are very pleased with these initial results from the NHS-Galleri trial, which is the largest randomized controlled trial of any MCED test,” added Ragusa. “We plan to share registrational data from the PATHFINDER 2 study later this year and final results from the NHS-Galleri trial in mid-2026.”
The NHS-Galleri trial was designed with three consecutive years of screening in order to achieve the primary endpoint, which is the absolute reduction in the number of late stage (stages 3 and 4) cancer diagnoses. Final clinical utility results from all three years of the trial are expected in mid-2026. GRAIL plans to submit data from the prevalent screening round of the NHS-Galleri trial as part of our premarket approval application in the first half of 2026.
Additional recent business highlights include:
· Data presented at American Association for Cancer Research (AACR) 2025 in April include:
- Real-world data in 100,000 patients demonstrating the Galleri test’s ability to simultaneously screen for multiple cancers, as well as its high accuracy of cancer signal of origin prediction to support efficient diagnostic evaluation. Test performance in this real world analysis was consistent with that observed in prior clinical studies.
- A modeling analysis highlighting that individuals receiving a negative MCED test have a reduced risk of cancer diagnosis for one year post-blood draw. The risk increases as the screening interval extends beyond one year, highlighting the importance of an annual MCED screening. (https://assets.grail.com/wp-content/uploads/2025/04/7132.Westgate.AACR-2025-Post-Test-Analysis_Poster_FINAL.pdf)
· Partnership with athenahealth to integrate ordering of the Galleri test into AthenaCoordinator Core, a leading cloud-based electronic health record (EHR) platform, helping to streamline the test ordering process and delivery of test results for more than 160,000 U.S. providers, and increase patient access.
· Partnership with award-winning actress Kate Walsh to launch Generation Possible, an educational initiative to raise awareness of MCED testing. More information about Generation Possible is available at GenPossible.com, including Walsh’s personal connection to cancer, details about MCED testing and access to important resources.
China Association of In-vitro Diagnostics
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