#USA #Menlo Park #GRAIL #cancer detection #Galleri

GRAIL Reports Third Quarter 2025 Financial Results

GRAIL, Inc., a trailblazer in early cancer detection, recently shared its third-quarter financial results for 2025, revealing a notable 26% increase in total revenue year-over-year, culminating in $36.2 million. Among this revenue, the Galleri test, a multi-cancer early detection test, achieved a remarkable $32.6 million in the U.S., marking a 28% growth compared to the previous year. The number of Galleri tests sold also saw a significant uptick, growing by 39% to exceed 45,000 tests.

Bob Ragusa, GRAIL’s CEO, expressed enthusiasm about the increasing adoption of the Galleri test, which is supported by the company’s efforts to raise awareness among healthcare providers and patients. The promising results emerging from clinical studies, including the PATHFINDER 2 trial, further bolster GRAIL’s position in the diagnostic landscape.

Looking beyond the U.S., GRAIL has forged a strategic collaboration with Samsung to introduce the Galleri test in key Asian markets, including Korea, Japan, and Singapore, aiming to expand its international footprint. Furthermore, Galleri's commercial introduction in Canada represents another step forward in GRAIL’s global strategy.

However, it was not all smooth sailing, as GRAIL reported a net loss of $89 million for the quarter, albeit a reduction from the previous year’s losses. This improvement reflects ongoing operational efficiencies and cost management despite expanding operational ambitions.

In tandem with its financial achievements, GRAIL revealed that its cash position remains robust, amassing over $850 million including funds obtained from a recent private placement of equity. This financial stability is projected to support the company's endeavors well into 2030.

Key highlights from the third quarter include:

• - Positive data from the PATHFINDER 2 and SYMPLIFY studies, reaffirming the Galleri test's efficacy in detecting various cancer types at early stages.
• - Increased advocacy for integrating Galleri into recommended cancer screenings, which has previously resulted in a significant rise in cancer detections, tripling the rate when combined with standard care.
• - Over half of the new cancers detected by Galleri were at stage 1 or 2, providing an opportunity for more effective treatments.
• - Galleri boasts an impressive specificity of 99.6%, translating to a low false positive rate of 0.4%, reinforcing its reliability as a screening tool.

In addition, a noteworthy partnership with Medcan will enhance the accessibility of Galleri tests at health clinics, further facilitating proactive health management offerings.

As GRAIL forges ahead, the anticipated Premarket Approval (PMA) submission for the Galleri test to the FDA is expected in Q1 2026, indicating a pivotal step towards regulatory endorsement and broader acceptance in cancer screening protocols. GRAIL continues to pioneer advancements in early cancer detection, positioning itself as a leader in the healthcare industry aiming to reduce the global burden of cancer.

In the exciting landscape of healthcare innovation, GRAIL’s persistent efforts signify a dedicated commitment to revolutionizing cancer detection and facilitating better patient outcomes. As the company makes strides in both operational growth and geographical expansion, it remains firmly focused on its mission to detect cancer early when it is most treatable and curable.

As GRAIL prepares for its Analyst Day 2025, taking place soon, stakeholders and potential investors will undoubtedly look forward to gleaning insights into its future growth strategies and next steps in its evolution within the healthcare space.