GRAIL Reports First Quarter 2025 Financial Results
Di rilievo, GRAIL ha annunciato risultati positivi a livello di top-line dal round di screening prevalente dello studio NHS-Galleri, mostrando un valore predittivo positivo superiore rispetto allo studio PATHFINDER, mantenendo al contempo un'accuratezza e specificità costanti nell'individuazione dell'origine del segnale tumorale. L'azienda prevede di presentare i dati per l'approvazione pre-mercato nella prima metà del 2026.
Tra le partnership chiave si annoverano l'integrazione con la piattaforma EHR di athenahealth e una nuova iniziativa educativa con l'attrice Kate Walsh chiamata Generation Possible.
Destaca que GRAIL anunció resultados positivos en la línea superior del ciclo de cribado prevalente del ensayo NHS-Galleri, mostrando un valor predictivo positivo mayor que el estudio PATHFINDER, manteniendo una precisión y especificidad constantes en la identificación del origen de la señal del cáncer. La compañía planea presentar los datos para la aprobación previa al mercado en la primera mitad de 2026.
Las asociaciones clave incluyen la integración con la plataforma EHR de athenahealth y una nueva iniciativa educativa con la actriz Kate Walsh llamada Generation Possible.
특히 GRAIL은 NHS-Galleri 시험의 선별 검사 라운드에서 긍정적인 주요 결과를 발표했으며, PATHFINDER 연구보다 높은 양성 예측값을 보여주면서 암 신호 기원 정확도와 특이도를 일관되게 유지했습니다. 회사는 2026년 상반기에 시판 전 승인 데이터를 제출할 계획입니다.
주요 파트너십으로는 athenahealth의 EHR 플랫폼 통합과 배우 케이트 월시와 함께하는 새로운 교육 이니셔티브인 Generation Possible이 포함됩니다.
Notamment, GRAIL a annoncé des résultats positifs de premier plan issus du cycle de dépistage prévalent de l'essai NHS-Galleri, montrant une valeur prédictive positive supérieure à celle de l'étude PATHFINDER, tout en conservant une précision et une spécificité constantes dans l'identification de l'origine du signal cancéreux. La société prévoit de soumettre les données pour une approbation pré-commerciale au premier semestre 2026.
Les partenariats clés incluent l'intégration avec la plateforme EHR d'athenahealth et une nouvelle initiative éducative avec l'actrice Kate Walsh intitulée Generation Possible.
Bemerkenswert ist, dass GRAIL positive Topline-Ergebnisse aus der Prävalenzscreening-Runde der NHS-Galleri-Studie bekannt gab, die einen höheren positiven prädiktiven Wert als die PATHFINDER-Studie aufweist und gleichzeitig eine konsistente Genauigkeit und Spezifität bei der Bestimmung des Krebsursprungs beibehält. Das Unternehmen plant, die Daten in der ersten Hälfte des Jahres 2026 zur Zulassung vor Markteinführung einzureichen.
Wichtige Partnerschaften umfassen die Integration mit der EHR-Plattform von athenahealth sowie eine neue Bildungsinitiative mit der Schauspielerin Kate Walsh namens Generation Possible.
- Revenue growth of 19% YoY to $31.8M, with U.S. Galleri revenue up 22% to $28.7M
- Strong cash position of $677.9M providing runway into 2028
- 51% improvement in net loss YoY
- Positive NHS-Galleri trial results showing higher positive predictive value than PATHFINDER study
- Strategic partnership with athenahealth expanding access to 160,000+ U.S. providers
- Continued net loss of $106.2M in Q1
- Gross loss of $19.9M despite revenue growth
- Final NHS-Galleri trial results not expected until mid-2026
- FDA approval still pending with premarket approval submission planned for H1 2026
Insights
GRAIL shows promising Q1 growth with Galleri test while reporting positive NHS trial results, maintaining strong cash position through 2028.
GRAIL's first quarter results demonstrate steady commercial traction for their Galleri multi-cancer early detection (MCED) test, with
The NHS-Galleri trial represents a crucial validation step as it's the largest randomized controlled trial of any MCED test. This initial data will likely form part of GRAIL's premarket approval application planned for first half of 2026, with final results expected mid-2026. The trial's primary endpoint - absolute reduction in late-stage (stages 3 and 4) cancer diagnoses - will be assessed after three consecutive years of screening.
Additional real-world data presented at AACR 2025 further validates the Galleri test's performance in 100,000 patients, with results consistent with prior clinical studies. Another important finding suggests that annual MCED screening is optimal, as cancer risk increases when the screening interval extends beyond one year.
GRAIL's partnerships with athenahealth to integrate test ordering into electronic health records and with actress Kate Walsh for awareness campaigns demonstrate strategic efforts to increase test accessibility and market penetration. Despite
GRAIL shows Q1 revenue growth and improved losses while maintaining strong cash position, despite continued profitability challenges.
GRAIL delivered solid revenue performance in Q1 2025 with total revenue of
On the profitability front, GRAIL is making progress but still facing challenges. The company reported a net loss of
GRAIL's financial position remains solid with
The company's strategic partnerships with athenahealth to integrate test ordering into EHR systems should help streamline operations and potentially accelerate adoption. While GRAIL continues to face substantial losses, the year-over-year improvement in financial metrics and strong cash position provide a foundation for continued development of their innovative cancer detection technology.
Q1
GRAIL Announces Positive Top-Line Results From the Prevalent Screening Round of the NHS-Galleri Trial
Cash Position of
Total revenue in the first quarter was
"We are pleased with the continued
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 $5.1 million 19% . - Net loss: Net loss was
$106.2 million $112.7 million 51% . - Gross loss: Gross loss was
$19.9 million $2.0 million 9% . - Adjusted gross profit1: Adjusted gross profit was
$14.3 million $2.3 million 19% . - Adjusted EBITDA1: Adjusted EBITDA was
$(98.7) million $53.2 million 35% .
Cash position: Cash, cash equivalents, restricted cash and short-term marketable securities totaled
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
"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
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. (https://assets.grail.com/wp-content/uploads/2025/04/7202.Matrana.AACR-2025-RWE-100K_Poster_Final.pdf)
- 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 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
For more information, visit grail.com.
About Galleri®
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:
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
Non-GAAP Disclosure
In addition to our financial results, this press release also includes financial measures that are not calculated in accordance with
- Adjusted Gross Profit (Loss) is a key performance measure that our management uses to assess our operational performance, as it represents the results of revenues and direct costs, which are key components of our operations. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it reflects the gross profitability of our operations, and excludes the indirect costs associated with our sales and marketing, product development, general and administrative activities, and depreciation and amortization, and the impact of our financing methods and income taxes.
We calculate Adjusted Gross Profit (Loss) as gross profit (loss) (as defined below) adjusted to exclude amortization of intangible assets and stock-based compensation allocated to cost of revenue. Adjusted Gross Profit (Loss) should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and other GAAP measures of income (loss) or profitability. The following table presents a reconciliation of gross loss, the most directly comparable financial measure calculated in accordance with GAAP, to Adjusted Gross Profit. - Adjusted EBITDA is a key performance measure that our management uses to assess our financial performance and is also used for internal planning and forecasting purposes. We believe that this non-GAAP financial measure is useful to investors and other interested parties in analyzing our financial performance because it provides a comparable overview of our operations across historical periods. In addition, we believe that providing Adjusted EBITDA, together with a reconciliation of net income (loss) to Adjusted EBITDA, helps investors make comparisons between our company and other companies that may have different capital structures, different tax rates, different operational and ownership histories, and/or different forms of employee compensation.
Adjusted EBITDA is used by our management team as an additional measure of our performance for purposes of business decision-making, including managing expenditures. Period-to-period comparisons of Adjusted EBITDA help our management identify additional trends in our financial results that may not be shown solely by period-to-period comparisons of net income (loss) or income (loss) from operations. Our management recognizes that Adjusted EBITDA has inherent limitations because of the excluded items, and may not be directly comparable to similarly titled metrics used by other companies.
Adjusted EBITDA should be viewed as a measure of operating performance that is a supplement to, and not a substitute for, operating income or loss from operations, net earnings or loss and otherU.S. GAAP measures of income (loss). Additionally, it is not intended to be a measure of free cash flow for management's discretionary use, as it does not consider certain cash requirements such as interest and tax payments. Further, our definition of Adjusted EBITDA may differ from similarly titled measures used by other companies and therefore may not be comparable among companies. The following table presents a reconciliation of net loss, the most directly comparable financial measure calculated in accordance withU.S. GAAP, to Adjusted EBITDA on a consolidated basis.
Full reconciliation of these non-GAAP measures to the most comparable GAAP measures is set forth in tabular form below.
Forward-Looking Statements
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of our future financial performance, future tests or products, technology, clinical studies, regulatory compliance, potential market opportunity, anticipated growth strategies, restructuring costs, sufficiency of cash on hand to finance our business, cost savings, budgets and strategies, restructuring and stock-based compensation costs, impact of the restructuring on our operations and growth and anticipated trends in our business.
These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the sections entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2025 and our Quarterly Report on Form 10-Q for the period ended March 31, 2025. For example, results from our ongoing or future studies, including the final results from our NHS-Galleri trial may be inconsistent with certain results obtained from our completed studies or from interim results initially reported on those studies, including the results reported from the prevalent screening round or our NHS-Galleri Trial. The NHS-Galleri trial was designed as three annual blood draws, plus 12 months follow up, in order to evaluate Galleri's ability to move forward the stage of cancer diagnosis relative to standard of care (primary endpoint). Cancer screening trials designed to show clinical utility, like the NHS-Galleri trial, are commonly conducted over three years with an annual screening interval, because results can be influenced by the fact that the first screening round detects many prevalent late-stage asymptomatic cancers that have not yet been diagnosed. This and other factors could cause final results of the three year trial to differ from a review of the first round results. Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make. Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
GRAIL | |||
Condensed Consolidated Balance Sheets | |||
(Unaudited) | |||
(in thousands, except for per share data) | |||
March 31, | December 31, | ||
Assets | |||
Current assets: | |||
Cash and cash equivalents | $ 133,895 | $ 214,234 | |
Short-term marketable securities | 540,688 | 549,236 | |
Accounts receivables, net | 19,309 | 20,312 | |
Supplies | 18,716 | 18,632 | |
Prepaid expenses and other current assets | 15,047 | 17,447 | |
Total current assets | 727,655 | 819,861 | |
Property and equipment, net | 64,615 | 69,061 | |
Operating lease right-of-use assets | 62,328 | 66,373 | |
Restricted cash | 3,349 | 3,349 | |
Intangible assets, net | 1,982,306 | 2,016,890 | |
Other non-current assets | 7,352 | 7,773 | |
Total assets | $ 2,847,605 | $ 2,983,307 | |
Liabilities and stockholders'/member's equity | |||
Current liabilities: | |||
Accounts payable | $ 5,769 | $ 4,844 | |
Accrued liabilities | 53,724 | 57,241 | |
Operating lease liabilities, current portion | 12,973 | 13,260 | |
Other current liabilities | 2,511 | 1,580 | |
Total current liabilities | 74,977 | 76,925 | |
Operating lease liabilities, net of current portion | 51,344 | 54,881 | |
Deferred tax liability, net | 305,192 | 345,860 | |
Other non-current liabilities | 2,424 | 2,236 | |
Total liabilities | 433,937 | 479,902 | |
Preferred stock, par value of | — | — | |
Common stock | 35 | 34 | |
Additional paid-in capital | 12,321,510 | 12,305,250 | |
Accumulated other comprehensive income | 1,666 | 1,451 | |
Accumulated deficit | (9,909,543) | (9,803,330) | |
Total stockholders'/member's equity | 2,413,668 | 2,503,405 | |
Total liabilities and stockholders'/member's equity | 2,847,605 | 2,983,307 | |
GRAIL | |||
Condensed Consolidated Statements of Operations | |||
(Unaudited) | |||
(amounts in thousands, except share and per share data) | |||
Three Months Ended | |||
March 31, | March 31, | ||
Revenue: | |||
Screening revenue | $ 29,133 | $ 23,539 | |
Development services revenue | 2,704 | 3,182 | |
Total revenue | 31,837 | 26,721 | |
Costs and operating expenses: | |||
Cost of screening revenue (exclusive of amortization of intangible assets) | 17,123 | 13,722 | |
Cost of development services revenue | 1,171 | 1,436 | |
Cost of revenue — amortization of intangible assets | 33,472 | 33,472 | |
Research and development | 53,625 | 101,625 | |
Sales and marketing | 34,979 | 46,819 | |
General and administrative | 45,074 | 57,069 | |
Total costs and operating expenses | 185,444 | 254,143 | |
Loss from operations | (153,607) | (227,422) | |
Other income (expense): | |||
Interest income | 7,779 | 2,901 | |
Other income (expense), net | (584) | 42 | |
Total other income, net | 7,195 | 2,943 | |
Loss before income taxes | (146,412) | (224,479) | |
Benefit from income taxes | 40,199 | 5,565 | |
Net loss | $ (106,213) | $ (218,914) | |
Net loss per share — Basic and Diluted | $ (3.10) | $ (7.05) | |
Weighted-average shares of common stock used in computing net loss per | 34,308,435 | 31,049,148 | |
GRAIL | |||
Reconciliation of GAAP to Non-GAAP Financial Measures | |||
(Unaudited) | |||
(amounts in thousands) | |||
Three Months Ended | |||
March 31, | March 31, | ||
Gross loss (1) | $ (19,929) | $ (21,909) | |
Amortization of intangible assets | 33,472 | 33,472 | |
Stock-based compensation | 762 | 481 | |
Adjusted Gross Profit | $ 14,305 | $ 12,044 | |
(1) | Gross profit (loss) is calculated as total revenue less cost of revenue (exclusive of amortization of intangible assets), cost of revenue—related parties, and cost of revenue—amortization of intangible assets. | ||||
GRAIL | |||
Reconciliation of GAAP to Non-GAAP Financial Measures | |||
(Unaudited) | |||
(amounts in thousands) | |||
Three Months Ended | |||
March 31, | March 31, | ||
Net loss | $ (106,213) | $ (218,914) | |
Adjusted to exclude the following: | |||
Interest income | (7,779) | (2,901) | |
Benefit from income tax expense | (40,199) | (5,565) | |
Amortization of intangible assets (1) | 34,584 | 34,584 | |
Depreciation | 4,695 | 5,413 | |
Illumina/GRAIL merger & divestiture legal and professional services costs(2) | — | 6,308 | |
Stock-based compensation (3) | 16,211 | 29,106 | |
Restructuring(4) | (34) | — | |
Adjusted EBITDA | $ (98,735) | $ (151,969) | |
(1) | Represents amortization of intangible assets, including developed technology and trade names. | ||||
(2) | Represents legal and professional services costs associated with the Acquisition and corresponding antitrust litigation, including compliance with the hold separate arrangements imposed by the European Commission, and legal and professional services costs associated with the divestiture. | ||||
(3) | Represents all stock-based compensation recognized on our standalone financial statements for the periods presented. | ||||
(4) | Represents employee severance, benefits, payroll taxes, and other costs associated with the Restructuring Plan. | ||||
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SOURCE GRAIL, Inc.
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