GRAIL Reports Third 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 third quarter of 2025.

Total revenue in the third quarter grew 26% year-over-year to $36.2 million, and Galleri revenue grew 29% year-over-year to $32.8 million. U.S. Galleri revenue was $32.6 million, representing 28% growth year-over-year. Net loss for the quarter was $89.0 million. Gross loss was $13.7 million. Non-GAAP adjusted gross profit was $20.0 million, and non-GAAP adjusted EBITDA was $(71.7) million.1

“We remain very pleased by Galleri’s commercial uptake with 39% growth in Galleri test volume in the third quarter. Our teams continue to build awareness of Galleri among providers and patients, and recent data from our registrational PATHFINDER 2 study adds to the evidence base,” said Bob Ragusa, Chief Executive Officer at GRAIL. “We have also made key recent strides in opportunities beyond the U.S., led by our strategic collaboration with Samsung to bring Galleri to key Asian markets, as well as Galleri’s commercial introduction in Canada. Looking ahead, we anticipate completing our PMA submission for Galleri to the FDA in the first quarter of 2026.”

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

· Revenue: Total revenue, comprised of screening and development services revenue, was $36.2 million, an increase of $7.5 million or 26%.

· Net loss: Net loss was $89.0 million, an improvement of $36.7 million or 29%.

· Gross loss: Gross loss was $13.7 million, an improvement of $8.5 million or 38%.

· Adjusted gross profit1: Adjusted gross profit was $20.0 million, an increase of $8.2 million or 69%.

· Adjusted EBITDA1: Adjusted EBITDA was $(71.7) million, an improvement of $36.5 million or 34%.

· Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled $547.1 million as of September 30, 2025.

Recent business highlights include:

· Positive results from PATHFINDER 2 and SYMPLIFY studies add to the evidence base for the effectiveness of multi-cancer early detection.

· Positive detailed performance and safety results from the pre-specified analysis of the first approximately 25,000 participants in the registrational PATHFINDER 2 study were presented at the European Society of Medical Oncology (“ESMO”) Congress 2025 in October:

 - Adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year

 - Galleri detected approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations)

 - Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options

 - More than half of the new cancers detected by Galleri were stage 1 or 2 and more than two-thirds were detected at stages 1-3

 - Galleri positive predictive value (“PPV”), or the likelihood of receiving a cancer diagnosis following a positive test result, was 61.6%

 - Specificity was 99.6%, translating to a false positive rate of 0.4%

 - Cancer signal of origin accuracy was 92%, leading to efficient diagnostic workups

 - Diagnostic resolution took a median of 46 days, and only 0.6% of all participants had an invasive procedure and invasive procedures were two times more common in participants with cancer than in those without

 - No serious, study-related adverse events were reported

· Positive long-term results from an extended registry follow-up of the SYMPLIFY study with the University of Oxford were presented at the Early Detection of Cancer Conference (“EDCC”) in October. A previous primary analysis, published in The Lancet Oncology, followed participants until diagnostic resolution or up to nine months and demonstrated Galleri’s PPV was 75.5%. Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales.

 - The updated analysis presented at EDCC showed that approximately one-third of participants initially believed to have a false positive result were later diagnosed with cancer during the subsequent follow up period

 - This reduction in false positives resulted in an increase of Galleri’s PPV in this symptomatic population to 84.2%

· Announced a collaboration with Medcan, a global leader in proactive health and wellness services, to provide access to the Galleri test at Medcan’s clinics. Additionally, Manulife Canada announced it now offers access to Galleri, in partnership with Medcan, to eligible life insurance customers through its innovative Manulife Vitality program.

· Announced a strategic collaboration with Samsung in October to bring the Galleri test to key Asian markets. Subject to execution of definitive agreements, the parties will work as exclusive partners to commercialize Galleri in Korea, and possibly other key Asian markets, including Japan and Singapore. In addition, the parties intend to explore potential additional strategic and operational collaborations. Samsung has also agreed to make an equity investment of $110 million in GRAIL, subject to closing conditions.

· Completed a private placement of equity in October resulting in gross proceeds of approximately $325 million, before deducting placement agents’ fees and other expenses. Including proceeds from this transaction, GRAIL’s cash position of more than $850 million provides runway into 2030.

Source: GRAIL Reports Third Quarter 2025 Financial Results