GRAIL Reports Second Quarter 2025 Financial Results

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 second quarter 2025.

Total revenue in the second quarter grew 11% year-over-year to $35.5 million, and Galleri revenue grew 22% year-over-year to $34.4 million. U.S. Galleri revenue was $34.2 million, representing 21% growth year-over-year. Net loss for the quarter was $114.0 million, which includes impairment of Illumina acquisition-related intangible assets of $28.0 million. Gross loss was $17.8 million. Non-GAAP adjusted gross profit was $16.1 million and non-GAAP adjusted EBITDA was $(78.3) million.1

“We are pleased with Galleri’s growing uptake in the U.S., with more than 45,000 Galleri tests sold in the second quarter, as we continue to drive provider and patient awareness of the MCED opportunity and Galleri’s ability to detect cancer earlier, when it is more amenable to treatment,” said Bob Ragusa, Chief Executive Officer at GRAIL. “Our registrational trials in large, intended use populations in the U.S. and U.K. are beginning to read out, and following very promising top-line performance and safety results from the PATHFINDER 2 study in the U.S., we plan to submit detailed results for presentation at the European Society for Medical Oncology Congress 2025 in October.”

For the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, GRAIL reported:

· Revenue: Total revenue, comprised of screening and development services revenue, was $35.5 million, an increase of $3.6 million or 11%.

· Net loss: Net loss was $114.0 million, an improvement of $1.5 billion or 93%. Net loss in the second quarter includes impairment of Illumina acquisition-related intangible assets of $28.0 million. In the second quarter of 2024, net loss included Illumina acquisition-related goodwill and intangible impairments of $1.42 billion.

· Gross loss: Gross loss was $17.8 million, an improvement of $0.1 million or 1%.

· Adjusted gross profit1: Adjusted gross profit was $16.1 million, an increase of $0.1 million or 1%.

· Adjusted EBITDA1: Adjusted EBITDA was $(78.3) million, an improvement of $61.1 million or 44%.

Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled $606.1 million as of June 30, 2025.

See “Non-GAAP Disclosure” and the associated reconciliations for important information about our use of non-GAAP measures.

Recent business highlights include:

· Positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in the registrational PATHFINDER 2 study were announced in June: 

 - Adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than that observed in the first PATHFINDER study. The first PATHFINDER study showed a more than doubling of the overall number of cancers detected when added to standard of care.

 - Positive predictive value (PPV) was substantially higher than the 43% PPV observed in the first PATHFINDER study.

 - Specificity and cancer signal origin (CSO) accuracy were consistent with the 99.5% and 88%, respectively, observed in the first PATHFINDER study. There were no serious safety concerns reported in PATHFINDER 2.

 - These data follow positive top-line results from the prevalent screening round of the registrational NHS-Galleri trial, which showed a substantially higher PPV than that observed in the PATHFINDER study. CSO accuracy and specificity were consistent with those observed in the PATHFINDER study. 

· Entered a new collaboration with Everlywell, a digital health company pioneering the next generation of biomarker intelligence, to expand access to the Galleri test. Galleri is now available for request directly on everlywell.com via prescription.

· In July, Rush University System for Health, one of the largest health systems in the U.S., announced it is the first health system in the Chicago-area market to offer the Galleri test.

· Data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in May included a 5-year follow up analysis of the Circulating Cell-free Genome Atlas (CCGA) study, which demonstrated Galleri’s preferential detection of aggressive, clinically meaningful cancers. (https://assets.grail.com/wp-content/uploads/2025/05/Swanton.ASCO-2025.CCGA-5-Year-Outcomes.Oral-Presentation_FINAL-1.pdf.) Findings are consistent with earlier analyses assessing the prognostic significance of Galleri’s cfDNA-based methylation approach.

Source: GRAIL Reports Second Quarter 2025 Financial Results