GRAIL Reports Second Quarter 2026 Financial Results

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])

CellFiber and Tidewave Bio Enter Collaboration to Evaluate Scalable 3D Manufacturing for Next-Generation Solid Tumor Immunotherapy

On August 5, 2026 CellFiber Co., Ltd. ("CellFiber"), a Tokyo-based biotechnology company built on its proprietary CellFiber cell encapsulation platform, and Tidewave Bio ("Tidewave"), a Los Angeles-based biotechnology company developing a universal, off-the-shelf immunotherapy platform for solid tumors, reported a collaboration to evaluate CellFiber’s closed, automated 3D cell culture platform in support of the scalable manufacturing of Tidewave’s next-generation cell immunotherapy.

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Under the collaboration, the parties have agreed to undertake a joint proof-of-concept evaluation comparing conventional planar (2D) cell culture against CellFiber’s encapsulation (3D) approach for the expansion and differentiation of immune cells relevant to Tidewave’s allogeneic platform. The work, to be conducted at CellFiber’s facility in Tokyo, is designed to generate process performance data that will drive Tidewave’s manufacturing strategy as the program advances, while demonstrating the applicability of the CellFiber platform to off-the-shelf solid tumor immunotherapy manufacturing. Any further activities beyond the proof-of-concept evaluation will be subject to separate written agreement between the parties.

"Tidewave Bio’s mission is to make next-generation cancer immunotherapy accessible to every solid tumor patient, regardless of tumor type, treatment setting, or geography," said Francois Binette, Chief Executive Officer of Tidewave Bio. "Delivering on that mission requires manufacturing approaches that can scale efficiently, reliably, and cost-effectively. We are pleased to partner with CellFiber to evaluate how their innovative encapsulation platform can support our process development strategy as we advance toward the clinic."

"Tidewave Bio is pursuing a genuinely differentiated approach to solid tumor immunotherapy, and we are excited to support their program," said Dr. Kazuchika Furuishi, Representative Director and Chief Executive Officer of CellFiber. "Our CellFiber platform was designed to remove the manufacturing bottlenecks that have historically constrained cell therapy scale-up. This collaboration is an opportunity to demonstrate the value our closed, automated 3D culture system can bring to the next generation of off-the-shelf cell therapies, and to advance our shared vision of making these therapies more widely accessible to patients."

(Press release, Tidewave Bio, AUG 5, 2026, View Source [SID1234669762])

RenovoRx to Highlight TAMP™ Platform at JonesTrading Virtual Key Opinion Leader Webinar on the Evolving Pancreatic Cancer Landscape, August 13th

On August 4, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported it will participate in a JonesTrading webinar with oncology key opinion leaders (KOLs) and Shaun Bagai, Chief Executive Officer of RenovoRx, on August 13, 2026 at 1:30 p.m. ET.

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The webinar, The Evolving Pancreatic Cancer Landscape: The Role of RenovoRx’s TAMP Platform and Emerging Clinical Advances, will be moderated by Justin Walsh, Equity Research Analyst covering the healthcare sector at JonesTrading. He will be joined by Dae Won Kim, MD, Medical Oncologist in Gastrointestinal Oncology at Moffitt Cancer Center, Ravi Shridhar, MD, PhD, Theranostic Program Director in the Department of Radiation Oncology at AdventHealth Cancer Institute, and Mr. Bagai.

Clinical Topics

● The exciting and rapidly evolving pancreatic cancer treatment landscape.

● RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) platform, enabled by the RenovoCath device, and its potential to deliver various existing and new chemotherapies locally rather than systemically.

● The ongoing Phase III TIGeR-PaC clinical trial, which is evaluating intra-arterial gemcitabine delivered via RenovoCath, as a potential treatment for locally advanced pancreatic cancer.

● Clinical experience integrating TAMP chemotherapy delivery via RenovoCath as a commercially available stand-alone medical device product into medical practice.

RenovoRx Commercial and Financial Topics

● Promising commercial launch of RenovoCath as a stand-alone device within its FDA-cleared uses, with growing revenues and a pathway for continued revenue expansion.

● Increasing the number of active commercial cancer center customers and their utilization of TAMP and RenovoCath to drive revenue and reduce the Company’s cash burn.

Webinar Details:

Title: The Evolving Pancreatic Cancer Landscape: The Role of RenovoRx’s TAMP Platform and Emerging Clinical Advances

Date: Thursday, August 13, 2026

Time: 1:30 p.m. ET

Speakers: Dae Won Kim, MD, Moffitt Cancer Center,
Ravi Shridhar, MD, PhD, AdventHealth Cancer Institute, and
Shaun Bagai, Chief Executive Officer, RenovoRx

Moderator: Justin Walsh, Equity Research Analyst, Healthcare, JonesTrading

Webcast: View Source

For interested individuals unable to join the webinar, a replay of the webcast will be available at View Source.

(Press release, Renovorx, AUG 4, 2026, View Source [SID1234669666])

Nuvectis Pharma Reports Second Quarter 2026 Financial Results and Business Highlights

On August 4, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, reported its financial results for the second quarter of 2026 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "The past several weeks mark a defining chapter for Nuvectis with the in-licensing of our new lead drug candidate, ciprocopan (NXP100), a Complement Factor B Inhibitor for once-daily oral administration, and the expansion of our oncology pipeline with the in-licensing of NXP200, an oral, brain-penetrant, paradox-breaker BRAF inhibitor. Approximately two weeks ago, ciprocopan received its first marketing approval in China for the treatment of patients with paroxysmal nocturnal hemoglobinuria ("PNH") not previously treated with complement inhibitors. This approval marks the first global approval of a once-daily, oral Complement Factor B inhibitor, bringing about a meaningful new treatment option for patients with PNH in China, and also highlights ciprocopan’s compelling clinical profile and provides further validation of its therapeutic potential as a treatment for a variety of complement-mediated diseases. We congratulate our partner Haisco on this significant achievement and are excited about the opportunity to follow suit in the United States and in the other licensed territories."

Mr. Bentsur concluded, "As expected following an in-licensing transaction that involves a late-stage asset with a multi-billion-dollar market potential, our main focus now is to advance ciprocopan toward a marketing application in the United States and other key territories, with NXP200 and NXP900 driving potential longer-term upside in the oncology segment. The successful $115M follow-on offering recently completed provides the resources necessary to advance our broad development strategy for NXP100 in PNH and other complement-mediated diseases and execute the next stage of development across our oncology portfolio."

Recent Developments

Completed public offering in July 2026 for gross proceeds of $115 million, which includes the exercise of the underwriters’ overallotment. Transaction was anchored by leading healthcare investors and extends our cash runway into 1H 2029.
Ciprocopan (NXP100)
In July 2026, our partner Haisco announced marketing approval of ciprocopan in China for the treatment of patients with PNH previously untreated with complement inhibitors. The marketing application in China for the treatment of PNH patients previously treated with anti C5 therapy is under review.
U.S. regulatory efforts underway; a pre-investigation new drug ("IND") meeting with the Food and Drug Administration ("FDA") followed by IND submission expected in 4Q2026.
NXP200
Phase 1b in China in patients with BRAF-mutated solid tumors is ongoing.
Oral presentation of additional clinical data generated by Haisco will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference (Madrid, Spain, October 23–27, 2026).
U.S. regulatory efforts underway; IND submission expected in 4Q2026.
NXP900
With the shift in corporate focus towards the development of ciprocopan, the NXP900 clinical development will now continue with the promising, higher potential impact, combination opportunities:
Non-small cell lung cancer (NSCLC): the clinical trial evaluating the combination of NXP900 plus osimertinib (Tagrisso) in patients with NSCLC EGFR+ who initially responded to, and later progressed on, osimertinib, is ongoing, and we expect to provide an update by the end of this year. The initiation of the combination study of NXP900 with lorlatinib (Lorbrena) in patients with NSCLC ALK+ who initially responded to, and later progressed on, an ALK inhibitor, is expected in 3Q2026.
Pancreatic cancer: Based on in-bound interest from two leading medical centers in the U.S., an investigator-sponsored trial (IST) is planned to evaluate the combination of NXP900 plus daraxonrasib in patients with pancreatic cancer at these centers. Study initiation is contingent on FDA approval and availability of daraxonrasib.

Second Quarter 2026 Financial Results

Cash, and cash equivalents were $22.2 million as of June 30, 2026, compared to $31.6 million as of December 31, 2025. In July, the Company raised $115 million in gross proceeds in a follow-on offering anchored by leading healthcare investors.

The Company’s net loss was $7.0 million for the three months ended June 30, 2026, compared to $6.3 million for the three months ended June 30, 2025, an increase in net loss of $0.7 million. Non-cash stock-based compensation was $1.7 million for the three months ended June 30, 2026, compared to $1.7 million for the three months ended June 30, 2025.

Research and development expenses were $4.7 million for the three months ended June 30, 2026, compared to $3.6 million for the three months ended June 30, 2025, an increase of $1.1 million. The increase was primarily driven by a $0.4 million increase in manufacturing costs, a $0.4 million increase in clinical trial expenses, and a $0.3 million increase in employee compensation and benefits.

General and administrative expenses were $2.5 million for the three months ended June 30, 2026, compared to $3.0 million for the three months ended June 30, 2025, a decrease of $0.5 million. The decrease was primarily driven by a $0.5 million decline in professional and consulting services related to public company expenses.

Finance income was $0.2 million for the three months ended June 30, 2026, and $0.3 million for the three months ended June 30, 2025.

(Press release, Nuvectis Pharma, AUG 4, 2026, View Source [SID1234669683])

Akari Therapeutics Releases CEO Corner Highlighting Strategic WhiteHawk Collaboration and the Expanding Opportunity for Dual-Payload ADC Innovation

On August 4, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported a new CEO Corner segment featuring President and Chief Executive Officer Abizer Gaslightwala discussing the Company’s recently announced strategic research collaboration with WhiteHawk Therapeutics and why the Company believes scientifically driven collaborations will play an increasingly important role in advancing the next generation of ADC innovation.

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In the segment, Mr. Gaslightwala discusses how the ADC landscape continues to evolve beyond the development of individual payload technologies toward collaborative strategies designed to combine complementary mechanisms of action. He explains why Akari believes bringing together differentiated scientific approaches has the potential to accelerate innovation, generate meaningful translational insights and expand future therapeutic opportunities beyond what may be achieved through a single technology alone.

At the center of the discussion is Akari’s recently announced strategic research collaboration with WhiteHawk Therapeutics, which combines Akari’s proprietary PH1 spliceosome-modulating payload with WhiteHawk’s differentiated TOP1 inhibitor ADC platform to evaluate a novel dual-payload strategy. Mr. Gaslightwala explains why the Company believes evaluating two potentially best-in-class payload technologies together represents an innovative scientific approach with the potential to broaden therapeutic activity while further demonstrating the versatility and broad applicability of Akari’s PH1 platform.

Beyond the collaboration itself, the CEO Corner explores the growing pharmaceutical industry interest in differentiated payload technologies capable of addressing important unmet needs across oncology. Mr. Gaslightwala discusses how strategic collaborations can provide additional opportunities to expand scientific validation of novel payload platforms while creating new pathways for innovation through partnerships with organizations that share a common vision for advancing ADC science.

Looking ahead, Mr. Gaslightwala outlines Akari’s continued focus on advancing AKTX-101, the Company’s lead TROP2-targeting ADC, toward planned Phase 1 clinical evaluation while continuing to expand the scientific foundation supporting its proprietary PH1 spliceosome-modulating payload platform. He emphasizes that the Company’s internal development programs and strategic collaborations represent complementary components of a broader strategy to establish PH1 as a differentiated payload platform with the potential to support multiple future therapeutic applications.

(Press release, Akari Therapeutics, AUG 4, 2026, View Source [SID1234669652])