On August 5, 2026 AbCellera (Nasdaq: ABCL) reported financial results for the second quarter of 2026. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"Last quarter we completed enrollment for the Phase 2 study of ABCL635, and we expect to announce top-line data very soon," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "Since our last business update we signed two new collaborations, one with Jazz and one with Vertex, that leverage our T-cell engager platform to advance programs into the clinic and are adding over $100 million in upfront cash to our balance sheet."

Q2 2026 Business Summary and Program Updates

ABCL635 top-line data readout from the Phase 2 trial expected in August 2026.
ABCL386 and ABCL688 are progressing through IND-enabling activities.
Announced collaboration with Jazz Pharmaceuticals plc to discover and develop next-generation T-cell engagers (TCEs) for multiple gastrointestinal cancers and other solid tumors. AbCellera is receiving $84 million in total upfront payments, with $56 million for the first two research programs and $28 million for a third program, which will initiate within 12 months. AbCellera is eligible to receive up to $792 million per program in option fees and development, regulatory, and commercial sales milestone payments along with tiered royalties on net sales ranging from mid-single digits to low double digits.
Completed dosing for the Phase 1 study of ABCL575, with top-line data readout expected in Q4 2026.
Announced the appointments of Dr. Victor Sandor and Dr. Lynn Seely as independent directors to AbCellera’s board of directors.
Generated a net loss of $55.4 million, compared to a net loss of $34.7 million in Q2 2025.
Ended the quarter with over $565 million in total cash balances and marketable securities, providing over $675 million in total available liquidity to execute on AbCellera’s strategy.
Subsequent Event

On July 29, 2026 announced a collaboration with Vertex Pharmaceuticals Incorporated to research, develop, manufacture, and commercialize multispecific TCEs for autoimmune diseases and other conditions. AbCellera will receive $28 million in total upfront payments and is eligible to receive preclinical, development, regulatory, and commercial milestone payments, along with tiered royalties on net sales.
Discussion of Q2 2026 Financial Results

Revenue – Total revenue was $4.1 million, compared to $17.1 million in Q2 2025.
Research & Development (R&D) Expenses – R&D expenses were $46.0 million, compared to $39.2 million in Q2 2025.
Sales, General, & Administrative (SG&A) Expenses – SG&A expenses were $13.9 million, compared to $22.0 million in Q2 2025.
Net Loss – Net loss of $55.4 million, or $(0.18) per share on a basic and diluted basis, compared to net loss of $34.7 million, or $(0.12) per share on a basic and diluted basis, in Q2 2025.
Available Liquidity – over $565 million in total cash balances and marketable securities, and $110 million in available non-dilutive government funding, bringing total available liquidity to over $675 million to execute on AbCellera’s strategy.
Business Metrics

At the end of Q2 2026, partners led 35 programs that AbCellera believes to be progressing and where AbCellera holds a downstream stake (down from 44 on December 31, 2025). In total, AbCellera held downstream stakes in 12 molecules in the clinic understood to be progressing on June 30, 2026.

Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

(Press release, AbCellera, AUG 5, 2026, View Source [SID1234669750])

On August 5, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a corporate update and announced financial results for the second quarter ended June 30, 2026.

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"This is a pivotal time for the CHD community, when availability of new therapies could improve awareness, testing and access to care. At EASL, experts emphasized that achieving durable suppression of hepatitis delta virus to undetectable levels is a key predictor of improved clinical outcomes for people with CHD. Our Week 96 SOLSTICE results demonstrate the potential of our dual-acting elebsiran and tobevibart combination regimen to rapidly achieve undetectable virus in most patients and raise the bar for treatment of this devastating condition," said Marianne De Backer, Chief Executive Officer of Vir Biotechnology. "Beyond CHD, we remain focused on rapid execution of our joint clinical program with Astellas in prostate cancer and have initiated monotherapy and combination therapy dose-expansion cohorts in our VIR-5500 Phase 1 study that will help inform pivotal trial design."

Pipeline Programs

Chronic Hepatitis Delta (CHD)

The Company completed enrollment in the Phase 3 ECLIPSE 2 trial, and the entire ECLIPSE registrational program is now fully enrolled. ECLIPSE 2 evaluates the efficacy and safety of switching from bulevirtide to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy and is intended support medication transitions as appropriate. These data, along with data from ECLIPSE 1 and 3, will be part of a comprehensive global filing package.
Topline data from the Phase 3 ECLIPSE 1 trial are expected in the fourth quarter of 2026.
Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027.
The Company presented complete Week 96 Phase 2 SOLSTICE data at the European Association for the Study of the Liver (EASL) Congress in May 2026.
In the intent-to-treat (ITT) analysis, the data showed 88% (28/32) of participants treated with the combination of elebsiran and tobevibart achieved undetectable hepatitis delta virus RNA (HDV RNA Target Not Detected, TND) compared to 53% (17/32) of participants on antibody monotherapy.
In the last observation carried forward analysis, the data showed the combination regimen achieved HDV RNA TND in 97% (31/32) of participants.
The combination regimen continues to be generally well tolerated. Treatment-emergent adverse events were generally mild to moderate and transient, and there were no treatment-related serious adverse events or discontinuations.
Solid Tumors

VIR-5500

The Company closed its global strategic collaboration with Astellas to advance PSMA-targeted, PRO-XTEN dual-masked T-cell engager (TCE) VIR-5500 for the treatment of prostate cancer. The companies have built a strong operational infrastructure for collaboration and rapidly worked together on Phase 1 trial design to advance the dose-expansion cohorts.
The Company initiated additional Phase 1 dose-expansion cohorts evaluating VIR-5500 at Q3W 800/2000/3500 µg/kg step-up dosing. The first patients were dosed in three monotherapy cohorts evaluating VIR-5500 in taxane naïve metastatic castration-resistant prostate cancer (mCRPC), radioligand therapy naïve mCRPC and radioligand therapy exposed mCRPC, and one combination cohort evaluating VIR-5500 in combination with enzalutamide in early-line mCRPC.
The Company anticipates initiating two additional Phase 1 dose-expansion cohorts, including VIR-5500 in combination with docetaxel in early-line mCRPC and VIR-5500 in combination with darolutamide in metastatic hormone-sensitive prostate cancer.
The Company anticipates initiating pivotal Phase 3 trials in 2027.
VIR-5818

The Company expects to report updated dose-escalation data from its Phase 1 trial evaluating VIR-5818, a HER2-targeted PRO-XTEN dual-masked TCE, as a monotherapy and in combination with pembrolizumab, in the second half of 2026. The dose-escalation parts of the Phase 1 trial have a basket design, enrolling across multiple tumor types.
VIR-5525

The Phase 1 trial of VIR-5525, an EGFR-targeted PRO-XTEN dual-masked TCE, as a monotherapy and in combination with pembrolizumab continues enrollment as expected.
Preclinical Pipeline Candidates

The Company is currently progressing a number of PRO-XTEN masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors.
Corporate Update

The Company appointed Timothy Coughlin, CPA to its Board of Directors and as Chair of the Audit Committee.
Second Quarter 2026 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2026, the Company had approximately $1.01 billion in cash, cash equivalents and investments, representing an increase of approximately $198.5 million during the second quarter of 2026. During the second quarter of 2026, the Company received a $240.0 million upfront payment and a $75 million equity investment payment from Astellas and made a $48.0 million pass-through payment to Sanofi.

Revenues: Total revenues for the second quarter of 2026 were $238.9 million, primarily reflecting license and collaboration revenue recognized in connection with the $240.0 million upfront payment received from Astellas in the quarter.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $135.3 million, which included $5.5 million of non-cash stock-based compensation expense, compared to $97.5 million for the same period in 2025, which included $6.9 million of non-cash stock-based compensation expense. The increase was primarily driven by a $48.0 million milestone payment to Sanofi triggered by the closing of our agreement with Astellas, as well as higher CHD contract manufacturing costs associated with process performance qualification batches in preparation for commercialization.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2026 were $30.2 million, which included $6.9 million of non-cash stock-based compensation expense, compared to $22.3 million for the same period in 2025, which included $5.5 million of non-cash stock-based compensation expense. The increase was primarily due to one-time advisory and legal fees in connection with the closing of our Astellas agreement.

Net Income (Loss): Net income for the second quarter of 2026 was $80.1 million, or $0.48 per share, basic and $0.47 per share, diluted, compared to a net loss of $111.0 million, or $0.80 per share, basic and diluted for the same period in 2025. The change from net loss to net income was primarily driven by $238.9 million in license and collaboration revenue recognized this quarter from the $240.0 million Astellas upfront payment.

2026 Financial Guidance

Based on our current operating plans, including the net effects of the Astellas global collaboration, the Company expects its cash, cash equivalents and investments to fund operations into the second half of 2028.

Conference Call

Vir Biotechnology will host its second quarter 2026 financial results conference call at 4:30 p.m. ET / 1:30 p.m. PT today. A live webcast will be available at View Source and will be archived for 30 days.

About the ECLIPSE Registrational Program

ECLIPSE is a registrational program to evaluate the safety and efficacy of elebsiran in combination with tobevibart in patients with chronic hepatitis delta (CHD). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of elebsiran in combination with tobevibart compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating the efficacy and safety of switching to elebsiran and tobevibart in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination elebsiran and tobevibart compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets.

About Elebsiran and Tobevibart

Elebsiran and tobevibart are investigational agents being evaluated as a novel combination regimen administered monthly as two separate sequential subcutaneous injections for the treatment of chronic hepatitis delta (CHD). The combination is designed to disrupt the hepatitis delta virus (HDV) life cycle at multiple points by addressing both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication.

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg.

Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting HBsAg. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend technology to extend half-life.

About Chronic Hepatitis Delta (CHD)

CHD is the most severe form of chronic viral hepatitis1 and was recently classified as carcinogenic by the International Agency for Research on Cancer.2 People living with the disease rapidly progress to cirrhosis, liver failure3 and liver-related death.1 Because ongoing hepatitis delta virus (HDV) replication drives disease progression, achieving undetectable virus, as defined by HDV RNA TND (target not detected), is considered an important virologic marker associated with improved clinical outcomes in CHD.4 Individuals with CHD who have detectable HDV RNA are at a higher risk of experiencing any liver-related event, including developing compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and mortality, compared to patients with undetectable HDV RNA.4 There are currently limited approved treatments in the U.S. and globally.

About VIR-5500, VIR-5818 and VIR-5525

VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN masking technology and target PSMA, HER2 and EGFR, respectively.

T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal PRO-XTEN masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent dosing regimens for patients and clinicians.

About Advanced Prostate Cancer

Prostate cancer remains a significant global health burden, representing the second leading cause of cancer-related mortality in men behind lung cancer.5 While diagnostic and therapeutic advances like androgen-directed therapy can improve outcomes in earlier settings, most patients ultimately relapse and develop metastatic hormone sensitive prostate cancer (mHSPC).6 mHSPC is characterized by its responsiveness to intensified hormonal interventions designed to reduce androgen levels or block their action. The majority of these patients eventually progress to metastatic castration-resistant prostate cancer (mCRPC).7 This stage is associated with poor clinical outcomes, including limited durability of existing therapies, with a 5-year survival rate of approximately 30%.8 There is a critical need for safer, more effective and precisely targeted therapies capable of improving long term disease control and quality of life across the prostate cancer continuum.

(Press release, Vir Biotechnology, AUG 5, 2026, View Source [SID1234669749])

On August 5, 2026 SystImmune, Inc., a clinical-stage biotechnology company and subsidiary of Biokin, reported that the first patient has been dosed in BrenDeLL-Lung01 (NCT07625644), a global Phase 3 registrational trial evaluating BL-M14D1 in combination with atezolizumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).

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BL-M14D1 is an investigational DLL3-targeted antibody-drug conjugate (ADC) built on SystImmune’s proprietary brengitecan platform and is being developed globally for the treatment of small cell lung cancer and other neuroendocrine malignancies.

"The initiation of our global Phase 3 program marks an important milestone for BL-M14D1 and reflects our commitment to bringing innovative treatment options to patients with small cell lung cancer," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "Despite recent advances, outcomes for patients with extensive-stage small cell lung cancer remain poor, and there continues to be a significant need for more effective therapies. We believe BL-M14D1 has the potential to improve outcomes for these patients, and we are excited to begin evaluating the program in a registrational setting."

The Phase 3 study follows encouraging clinical activity observed in the ongoing Phase 1 BL-M14D1-101 trial recently presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These results demonstrated promising anti-tumor activity and a manageable safety profile in heavily pre-treated patients with small cell lung cancer and other neuroendocrine carcinomas, supporting advancement of the program into late-stage development.

About the BrenDeLL-Lung01 Phase 3 Clinical Trial
BrenDeLL-Lung01 (NCT07625644) is a global, multi-center, randomized Phase 3 trial evaluating BL-M14D1 in combination with atezolizumab versus standard-of-care platinum and etoposide induction followed by atezolizumab maintenance, with or without lurbinectedin, in patients with previously untreated extensive-stage small cell lung cancer. The study intends to enroll approximately 580 patients and the primary endpoint for this study is progression-free survival as assessed by blinded independent central review (BICR).

About BL-M14D1
SystImmune is advancing a portfolio of next-generation antibody-drug conjugates (ADCs) built on its proprietary brengitecan platform, which utilizes a potent topoisomerase I inhibitor payload designed for targeted delivery to tumor cells. The clinical progress of izalontamab brengitecan (iza-bren) provides initial validation of this platform’s potential to deliver meaningful anti-tumor activity across multiple cancer types.

BL-M14D1 targets DLL3, which is highly expressed in small-cell lung cancer and neuroendocrine tumors, facilitating selective delivery of the brengitecan payload to DLL3-positive tumor cells.

(Press release, SystImmune, AUG 5, 2026, View Source [SID1234669748])

On August 5, 2026 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, was the first to demonstrate the isolation and analysis of >99% pure circulating tumor-derived DNA (ctDNA), reported the publication of the first peer-reviewed paper describing the technology in detail – entitled "Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: Measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy1".

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Most current liquid biopsy methods involve deep sequencing of plasma DNA and bioinformatic analysis of the data produced to identify the presence of cancer in a patient. The biggest problem facing all liquid biopsy methods worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not cancer cells. Volition’s new technology employs an entirely novel approach to liquid biopsy that has overcome this hurdle and produced >99% pure cancer associated plasma DNA sequence sets for liquid biopsy.

Mr. Gael Forterre, Chief Licensing Officer, Volition added:

"We are delighted that the paper detailing this breakthrough technology has been peer reviewed and published.

"We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development of this technology, "Capture-Seq", and indeed are in the process of undertaking technical evaluations with potential licensors.

"We believe the potential use cases for Capture-Seq represent a significant commercial opportunity with a Total Addressable Market on an annualized basis of approximately $23 billion2 for the human Multi-Cancer Early Detection (MCED) use, and over $13 Billion2 for Minimum Residual Disease (MRD)."

Dr Jake Micallef, Chief Scientific Officer, Volition commented:

"Distinguishing cancer derived plasma DNA from healthy DNA when the two are mixed is problematic as they are chemically similar. As the cancer DNA may make up 1% or less of the total DNA, it is extremely problematic.

"Our manuscript describes a new liquid biopsy chemistry for isolating CTCF-DNA from plasma. Our work on CTCF-bound DNA has revealed what we believe to be an unprecedented new discovery; that there is almost no CTCF-bound DNA in healthy plasma and almost all CTCF-bound DNA in the blood of a cancer patient is derived from cancer cells – i.e. it is virtually pure circulating tumor-derived DNA.

"Removal of background normal cell free DNA from the blood to reveal this level of tumor derived DNA has been a long term goal of liquid biopsy. I believe this is a world-first and could, in my opinion, represent the biggest scientific breakthrough in cancer testing and monitoring in recent years.

"In this published paper we report a new, two-step method for preparing pure circulating tumor DNA data sets for cancer patients:

physical enrichment of the sample; and
bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set.
"This new method produced >99% pure ctDNA sequencing data sets for blood samples from cancer patients and, whilst we capture a subset of the ctDNA (i.e. not all the ctDNA in a sample), it is virtually pure cancer DNA.

"These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers. Capture-Seq shows potential for both a multi-cancer early detection (MCED) approach, either alone or in combination with other tests, and the detection of Minimal Residual Disease (MRD).

"We are fast-tracking the development of Capture-Seq conducting further studies, including competing conditions and larger sample sets and working with oncology Key Opinion Leaders.

"Volition is, I believe, the first liquid biopsy company to focus on circulating cell free nucleoproteins and we have filed a number of new patents to protect this technology."

Dr Andrew Retter, Medical Consultant, Volition commented:

"From a clinical perspective, the proof of concept and early blinded validation results reported in this paper are extremely encouraging. In two independent cohorts we reported no false positives and detected 49/49 cancers in the first cohort (including 23 early stage I/II and 21 controls) and validated it in a second blinded cohort with 13/14 later stage cancers detected with 10 additional controls.

"We have also subsequently reported data from a blinded validation cohort of 81 subjects (colorectal and lung cancer patients = 59, healthy controls = 22) and are extremely encouraged by the results; the early-stage cancer detection of 95% of stage I and II cancers is particularly noteworthy.

"For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq could contribute to Multi-Cancer Early Detection (MCED) fulfilling a significant unmet clinical need.

"We also believe that Capture-Seq has the potential to play a role in cancer management, including but not limited to, Minimal Residual Disease detection and treatment monitoring, either alone or potentially in combination with other technologies too."

Pamart, D., et al. Direct analysis of transcription factor protected cfDNA in plasma by ChIP-seq: measurement of altered CTCF binding in cancer is a novel biomarker for liquid biopsy. Clin Epigenet (2026). View Source
Data on File : Volition TAM Model

(Press release, VolitionRX, AUG 5, 2026, View Source [SID1234669747])

On August 5, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported business and financial results for the second quarter of 2026.

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Total revenue in the second quarter grew 26% year-over-year to $44.7 million, and Galleri test revenue for the quarter grew 24% year-over-year to $42.6 million. Galleri test volume for the quarter grew 35% year-over-year to more than 61,000. Galleri test revenue in the first half of 2026 grew 30% year-over-year to $82.5 million. Galleri test volume in the first half of 2026 grew 42% year-over-year to more than 117,000. Net loss for the second quarter was $110.2 million. Gross loss was $12.6 million. Non-GAAP adjusted gross profit was $21.6 million, and non-GAAP adjusted EBITDA was $(90.3) million.1

"GRAIL continues to execute across our clinical and commercial priorities. We presented detailed performance, safety, and clinical utility results from the NHS-Galleri and PATHFINDER 2 studies at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies in the screening population. We also expanded access through new and existing partnerships," said Josh Ofman, Chief Executive Officer at GRAIL. "Following our PMA submission earlier this year, we anticipate an FDA advisory committee in the fall."

For the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, GRAIL reported:

Revenue: Total revenue, comprised of screening and development services revenue, was $44.7 million, an increase of $9.1 million or 26%.
Net loss: Net loss was $110.2 million, an improvement of $3.7 million or 3%.
Gross loss: Gross loss was $12.6 million, an improvement of $5.2 million or 29%.
Adjusted gross profit1: Adjusted gross profit was $21.6 million, an increase of $5.4 million or 34%.
Adjusted EBITDA1: Adjusted EBITDA was $(90.3) million, an increase in adjusted EBITDA loss of $11.9 million or 15%.
_______________________________
1 See "Non-GAAP Disclosure" and the associated reconciliations for important information about our use of non-GAAP measures.

Cash position: Cash, cash equivalents, and short-term marketable securities totaled $861.6 million as of June 30, 2026.

Recent business highlights include:

Presented detailed results from the two largest multi-cancer early detection (MCED) studies completed to date, NHS-Galleri and PATHFINDER 2, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May.

Clinical utility results from the NHS-Galleri trial showed:
While Galleri did not result in a significant decrease in combined Stage III and IV cancers, it did show reduced Stage IV diagnoses of 12 prespecified aggressive cancers by 22% and 26% in the second and third screening rounds, respectively, demonstrating a substantial reduction in late-stage cancer diagnoses. A Stage IV reduction was also observed across all cancers.
Adding Galleri to standard-of-care screening increased cancer detection fourfold.
The addition of Galleri resulted in a 128% increase in the number of Stage I and II screen detected cancers.
Galleri detected 366 Stage I and II cancers, more than the 290 cancers of any stage detected through the entirety of the U.K.’s standard-of-care cancer screening program in the control arm.
Of the 937 cancers detected by Galleri, approximately 70% were Stage I through III, approximately 40% were Stage I and II, and approximately 20% were Stage I.
Further, the addition of Galleri was associated with a 25% reduction in cancers diagnosed after emergency presentation.
Overall, these data support the potential of MCED screening at population scale to identify cancers before symptoms appear — when they can be treated more easily and are potentially curable.
Findings from PATHFINDER 2 showed:
Adding Galleri to recommended screenings, enabled approximately 60% of cancers to be identified by screening. This represents a 6.5x increase in number of cancers detected as compared with USPSTF A & B recommended screenings (breast, cervical, colorectal, and lung) and a 3x increase in number of cancers detected as compared with USPSTF A, B & C ratings (breast, cervical, colorectal, lung and prostate).
53% of newly detected cancers were identified in Stage I and II and more than two-thirds were identified at Stages I through III. Nearly half were cancers without recommended screening options.
The test accurately identified the Cancer Signal Origin (CSO) more than 90% of the time, enabling efficient diagnostic workups.
Overall, the results demonstrated substantially increased cancer detection with robust performance and a favorable safety profile.

Completed the expansion of our field sales and medical teams to continue to drive commercial momentum for the Galleri test.

Announced a collaboration with Priority Health to make the Galleri test available to its self-insured employer groups, making it the first Michigan health plan to enable employer groups to add Galleri to their existing cancer screening coverage. The health plan serves more than 1.4 million members across Michigan and beyond and previously launched coverage for Galleri in its Thrive and Thrive Plus Medicare Advantage plans in 2025.

In June, GRAIL completed a previously announced $110 million equity financing with Samsung C&T Corporation and Samsung Electronics Co., Ltd. through the purchase of GRAIL common stock. GRAIL and Samsung C&T intend to collaborate to commercialize the Galleri test in South Korea, with the potential to expand into additional Asian markets, including Japan and Singapore, subject to regulatory approvals and other conditions.

GRAIL anticipates the U.S. Food and Drug Administration (FDA) will hold an advisory committee in the fall to review the Premarket Approval (PMA) application for the Galleri multi-cancer early detection blood test. The PMA submission is focused on test performance and safety results from 25,000 consented participants in the U.S.-based PATHFINDER 2 study with one year of follow-up and from the prevalent screening round (first year) of the 140,000-participant NHS-Galleri trial, the largest, and only, randomized, controlled intended use trial of any MCED test. The submission is also supported by a bridging analysis to compare performance of the version of Galleri used in clinical trials to the updated version that has been submitted to the FDA for pre-market approval.
Conference Call and Webcast
A webcast and conference call will be held today, August 5, 2026, 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.

(Press release, Grail, AUG 5, 2026, View Source [SID1234669746])