GRAIL Reports First Quarter 2025 Financial Results

PR Newswire

MENLO PARK, Calif., May 13, 2025

Q1 U.S. Galleri Revenue Grew 22% Year-Over-Year to $28.7 Million

GRAIL Announces Positive Top-Line Results From the Prevalent Screening Round of the NHS-Galleri Trial

Cash Position of $677.9 Million Provides Runway Into 2028

MENLO PARK, Calif., May 13, 2025 /PRNewswire/ -- 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.

 
 
(1) See "Non-GAAP Disclosure" and the associated reconciliations for important 
information about our use of non-GAAP measures. 
 

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. 
              
 
 
   -- 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 
      GenPosssible.com, including Walsh's personal connection to cancer, 
      details about MCED testing and access to important resources. 

Conference Call and Webcast

A webcast and conference call will be held today, May 13, 2025, at 1:30 p.m. PT / 4:30 p.m. ET. Individuals interested in listening to the conference call may access it on the investor relations section of GRAIL's website at investors.grail.com.

A replay of the webcast will be available on GRAIL's website for 30 days.

About GRAIL

GRAIL, Inc. is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL's common stock is listed under the ticker symbol "GRAL" on the Nasdaq Stock Exchange.

For more information, visit grail.com.

About Galleri$(R)$

The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, to help screen for some of the deadliest cancers that do not have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen $(PSA)$ test, or cervical cancer screening. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.

For more information, visit galleri.com.

* Sensitivity in CCGA study participants with -- Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II, 85.7% stage III, 95.9% stage IV). Esophagus cancer 85.0% overall (12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV). Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1% stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5% overall (100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).

Laboratory/Test Information

GRAIL's clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 $(CLIA)$ and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL's clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

Non-GAAP Disclosure

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