On August 5, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its Phase II clinical study evaluating Opamtistomig (LBL-024), a proprietary PD-L1/4-1BB bispecific antibody, in combination with bevacizumab for the treatment of first-line hepatocellular carcinoma (HCC) has successfully completed the safety run-in phase assessment following expert review and has advanced into the expansion phase. The study is led by Professor Zhou Jian, President of Zhongshan Hospital, Fudan University, and Academician of the Chinese Academy of Sciences.

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Preliminary clinical data demonstrated that Opamtistomig in combination with bevacizumab has shown encouraging anti-tumor activity and a favorable safety profile in patients with HCC, supporting further clinical evaluation in the expansion phase.

HCC represents a significant global health burden and is the fourth most common malignant tumor and the second leading cause of cancer-related mortality in China, with approximately 368,000 new cases and 317,000 deaths recorded annually. Due to its often insidious onset, fewer than 30% of patients are eligible for potentially curative treatment at diagnosis, making systemic anti-tumor therapies essential for patients with intermediate-to-advanced disease.

Currently, PD-1/PD-L1 inhibitors in combination with bevacizumab have become one of the first-line standard treatments for advanced HCC both in China and globally; however, median overall survival is only approximately 19 to 20 months, median progression-free survival is less than 7 months, and the objective response rate does not exceed 30%. These limitations highlight the urgent need for more effective and durable treatment strategies.

Opamtistomig has demonstrated promising efficacy signals and broad therapeutic potential across multiple tumor types, including extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and biliary tract cancer (BTC). Powered by the proprietary X-body platform, which enables tumor-localized activation of 4-1BB signaling, Opamtistomig has maintained a favorable safety profile across nearly 800 treated patients, further supporting its potential as a next-generation IO 2.0 pan-tumor immunotherapy platform. The encouraging clinical findings in HCC further strengthen the clinical validation of Opamtistomig’s differentiated mechanism and therapeutic potential.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "Advancing this Phase II study of Opamtistomig in first-line HCC into expansion phase is an important milestone in validating its potential as a pan-tumor immunotherapy. While PD-1/PD-L1-based combination therapies have become the standard of care for first-line HCC, significant unmet medical needs remain. The encouraging efficacy signals observed with Opamtistomig in combination with bevacizumab provide further confidence in its potential to improve treatment outcomes for patients with HCC. We will continue to accelerate clinical development and global registration efforts to bring this innovative therapy to patients worldwide as quickly as possible."

About HCC
According to data published by the World Health Organization ("WHO"), the global annual number of new HCC cases reached 865,000 in 2022, ranking sixth among malignant tumors, with 758,000 deaths, ranking third among malignant tumors. HCC is particularly prevalent in China, where it is the fourth most common malignant tumor and the second leading cause of cancer-related deaths. Although China’s population accounts for only 18.4% of the global population, the country accounts for 368,000 new HCC cases and 317,000 deaths annually, representing 42.5% and 41.8% of the global totals, respectively.

HCC is the predominant type of primary liver cancer, accounting for approximately 85% to 90% of cases. It has an insidious onset and is highly aggressive, with most patients diagnosed at an intermediate to advanced stage and a correspondingly poor prognosis. The five-year survival rate is 15% to 19% in North America, compared with only 12.1% in China, posing a serious threat to the health and lives of the Chinese population and making the reduction of the HCC disease burden a major public health issue requiring urgent attention in China.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, AUG 5, 2026, View Source [SID1234669755])

On August 5, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"Silevertinib continued to demonstrate robust clinical activity and durable responses in frontline patients with non-classical EGFR-mutant NSCLC, as presented at ASCO (Free ASCO Whitepaper) in May," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are particularly encouraged that no patients developed de novo brain metastases and that the CNS ORR was 86% in patients with baseline brain metastases. Approximately 80% of all patients with non-classical EGFR mutations progress in the brain, and approximately 40% of patients with non-classical EGFR-mutant NSCLC present with brain metastases at diagnosis, underscoring silevertinib’s potential to address this significant unmet medical need. We look forward to engaging with the FDA and providing an update on the pivotal development path for silevertinib in frontline NSCLC in the fourth quarter."

Recent Developments & Upcoming Milestones:
•On May 30, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, data were presented from the Phase 2 trial of silevertinib dosed at 200 mg once daily (QD) in 43 frontline NSCLC patients harboring a broad spectrum of EGFR non-classical mutations, including compound and P-Loop and C-Helix Compressing (PACC) mutations. As of an April 11, 2026 data cutoff date, results were as follows:
◦Objective Response Rate (ORR by RECIST 1.1), CNS ORR (ORR by RANO-BM), and Disease Control Rate (DCR) were 60%, 86% and 91%, respectively
◦Variant allele frequency reduction observed in all evaluable patients across 25 unique EGFR non-classical mutations, including PACC
◦Median duration of response had not been reached (95% CI: 7.0, NE)
◦Preliminary median progression-free survival of 15.2 months (95% CI: 10.8, NE)
◦No patients developed de novo brain metastases
◦23 of 43 patients (53%) remained on therapy, with the longest at 23.5 months
◦No new safety signals were observed. The rate of treatment-related adverse events greater than or equal to Grade 3 was reduced to 28% following dose reduction, and patients maintained or deepened clinical responses after dose reduction.
◦Safety, pharmacokinetics, pharmacodynamics and efficacy data support a 150 mg QD dose for pivotal development

•The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026.
•The Company is seeking U.S. Food and Drug Administration (FDA) feedback on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC, and expects to provide an update in the fourth quarter of 2026.
•The Phase 2 trial of silevertinib in combination with temozolomide in newly diagnosed EGFRvIII+ glioblastoma (GBM) is enrolling patients in the safety lead-in portion of the study. The Company remains on track to initiate the randomized portion of the study in the fourth quarter of 2026.
Financial Highlights
•Cash Position: Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $8.0 million for the second quarter of 2026 compared to net cash used in operations of $9.2 million for the second quarter of 2025.
•Research and Development Expenses: Research and development (R&D) expenses were $7.4 million for the second quarter of 2026, compared to $9.3 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 trial for silevertinib in NSCLC, partially offset by increased spend related to the start-up activities for the Phase 2 trial for silevertinib in GBM.
•General and Administrative Expenses: General and administrative (G&A) expenses were $4.7 million for the second quarter of 2026, compared to $4.1 million for the same period in 2025. The increase in G&A expenses was primarily due to an increase in IP-related costs.
•Net Loss: Net loss for the second quarter of 2026 was $9.9 million, as compared to a net loss of $10.6 million for the same period in 2025.
Financial Guidance
•Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
About Silevertinib
Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib.
In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

(Press release, Black Diamond Therapeutics, AUG 5, 2026, View Source [SID1234669719])

On August 5, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for Bria-PROS+ and issued a Study May Proceed letter, clearing the way for clinical evaluation of Bria-PROS+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for prostate cancer.

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"We are pleased to announce FDA clearance of the IND for Bria-PROS+, our next-generation personalized immunotherapy for prostate cancer," stated Dr. William V. Williams, BriaCell’s President & CEO. "Bria-PROS+ is designed to activate multiple components of the immune system, which we believe has the potential to support meaningful therapeutic benefit with a favorable safety profile. We look forward to advancing Bria-PROS+ into the clinic as we work to develop new treatment options for patients with advanced prostate cancer."

In August 2025, BriaCell was awarded a $2 million non-dilutive grant from the US National Cancer Institute to support the manufacturing and planned clinical evaluation of Bria-PROS+.

As reported in BriaCell’s preclinical poster presentation, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Bria-PROS+ demonstrated activation of both adaptive and innate immune responses including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with prostate cancer.

BriaCell’s Bria-PROS+ builds on the Company’s oncology platform with its Bria-IMT program, currently in its Phase 3 pivotal trial for metastatic breast cancer, its Bria-OTS breast cancer clinical program, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and its Bria-BRES+ program, which recently received FDA clearance to initiate clinical evaluation of its enhanced, personalized, off-the-shelf cellular immunotherapy for breast cancer. Bria-PROS+, Bria-OTS and Bria-BRES+ programs are personalized immunotherapies, based on HLA matching between patients and the respective immunotherapy cell lines.

(Press release, BriaCell Therapeutics, AUG 5, 2026, View Source [SID1234669756])

On August 5, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter ended June 27, 2026.

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Key Highlights
•Reports second-quarter revenue of $1.00 billion, GAAP loss per share of $(0.03), and non-GAAP earnings per share of $3.02.
•Organic revenue growth of 0.1% reached the highest level since the third quarter of 2023.
•Non-GAAP operating margin increased 420 basis points on a sequential basis to 20.5%, while the GAAP operating margin was essentially flat on a sequential basis at 11.9%.
•Increases 2026 guidance for revenue and non-GAAP earnings per share.
•Organic revenue guidance increasing by 150 basis points and non-GAAP earnings per share guidance increasing by $0.25 at midpoint.
•Guidance increases primarily driven by improving demand trends in the DSA segment and better-than-expected performance in the Manufacturing segment.
•Repurchased $100 million of common stock in the second quarter at an average price of $174 per share to enhance shareholder value.
•To refine and further strengthen its portfolio, the Company completed the divestitures of certain European Discovery Services sites as well as the CDMO and Cell Solutions businesses in May 2026.
•To further deepen its client relationships, the Company has joined Eli Lilly’s TuneLab AI/ML platform by providing non-clinical testing expertise to optimize drug discovery and advance R&D modernization efforts. Additionally, it has collaborated with Arovella Therapeutics to provide in vitro Next Generation Sequencing (NGS) services, which was added through the PathoQuest acquisition. This collaboration will accelerate progress towards Arovella’s alternative cancer treatment approaches.
•To advance its modernization efforts, Charles River introduced an enhanced digital pathology solution to drive efforts to further digitize and automate the Company. This AI-enabled, end-to-end workflow will deliver improved study turnaround times and increased pathologist efficiency.

Second-Quarter Results
Revenue was $1.00 billion, a decrease of 2.7% from $1.03 billion in the second quarter of 2025. On an organic basis, revenue increased 0.1%, driven by revenue growth in the Manufacturing Solutions (Manufacturing) and Discovery and Safety Assessment (DSA) segments, offset by a decline in the Research Models and Services (RMS) segment. Organic revenue growth excludes the effect of acquisitions, divestitures, and foreign currency translation.
In the second quarter of 2026, the GAAP operating margin was 11.9%, compared to 9.7% in the second quarter of 2025. The increase in the GAAP operating margin was primarily driven by the CDMO business, including lower accelerated amortization expense related to certain client relationships. The GAAP net loss available to common shareholders for the second quarter of 2026 was $(1.5) million, or $(0.03) per diluted share, compared to GAAP net income of $52.3 million, or $1.06 per diluted share for the same period in 2025. The decrease was principally due to a loss related to the CDMO and Cell Solutions divestiture totaling $63.7 million, or $1.40 per share.
On a non-GAAP basis, the second-quarter operating margin decreased to 20.5% from 22.1% in the second quarter of 2025, primarily as a result of higher study-related direct costs in the DSA segment and higher unallocated corporate costs. Non-GAAP net income was $146.2 million for the second quarter of 2026, a decrease of 5.0% from $154.0 million for the same period in 2025. Second-quarter diluted earnings per share on a non-GAAP basis were $3.02, a decrease of 3.2% from $3.12 per share in the second quarter of 2025. The non-GAAP net income and earnings per share decreases were driven primarily by the lower operating margin. The earnings per share decrease was partially offset by investment gains associated with the Company’s deferred compensation plan, which totaled a net benefit of $0.19 per share in the second quarter.

Birgit Girshick, Chief Executive Officer, said, "We made excellent progress in the second quarter on the execution of our Pathway to Purpose strategy. We are actively evaluating opportunities to modernize the Company and drive greater efficiency, to strengthen our leading drug development portfolio centered on regulated testing, and to further enhance our growth profile. We are focused on continuing to move forward on achieving our strategic initiatives and financial goals, which will strengthen our foundation and underpin our future success."

"We were encouraged that the demand environment continued to strengthen in the second quarter, particularly for our DSA segment, as evidenced by the fact that we recorded the highest net book-to-bill in nearly four years. This improvement was broad based across our global biopharmaceutical and small and mid-sized biotechnology clients, and it is our goal to continue to capture additional share of our clients’ R&D spending by providing client-centric solutions and by leveraging our global scale and deep scientific expertise. As a result of our collective efforts, we delivered on our second-quarter financial targets – exceeding our prior outlook – and are raising our revenue and non-GAAP earnings per share guidance for the year," Ms. Girshick concluded.

Second-Quarter Segment Results
Research Models and Services (RMS)
Revenue for the RMS segment was $209.5 million in the second quarter of 2026, a decrease of 1.8% from $213.3 million in the second quarter of 2025. Organic revenue decreased by 1.4%, due primarily to lower revenue for small research models in North America, as well as for research model services. The decline was partially offset by higher revenue for small research models in China.
In the second quarter of 2026, the RMS segment’s GAAP operating margin increased to 17.3% from 16.8% in the second quarter of 2025, primarily due to lower amortization of intangible assets related to the sale of the Cell Solutions business. On a non-GAAP basis, the operating margin decreased to 24.5% from 25.3%. The non-GAAP operating margin decrease was primarily driven by the impact of lower sales volume and an unfavorable geographic revenue mix.

Discovery and Safety Assessment (DSA)
Revenue for the DSA segment was $606.5 million in the second quarter of 2026, a decrease of 1.9% from $618.0 million in the second quarter of 2025. Organic revenue increased by 0.2%, driven primarily by higher study volume for regulated safety assessment services.
In the second quarter of 2026, the DSA segment’s GAAP operating margin increased to 20.5% from 19.9% in the second quarter of 2025. The increase was primarily driven by lower amortization of intangible assets related to the divestiture of certain European Discovery Services sites and lower third-party legal costs related to a non-human primate (NHP) supply matter. On a non-GAAP basis, the operating margin decreased to 25.6% from 27.4% in the second quarter of 2025. The non-GAAP operating margin decrease was primarily driven by higher study-related direct costs.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $188.1 million in the second quarter of 2026, a decrease of 6.3% from $200.8 million in the second quarter of 2025, primarily driven by the CDMO divestiture. Organic revenue increased 1.3%, driven primarily by higher revenue in the Microbial Solutions business.
The Manufacturing segment’s GAAP operating margin was 34.9%, compared to 6.0% in the second quarter of 2025. On a non-GAAP basis, the operating margin increased to 37.8% from 32.8% in the second quarter of 2025. The GAAP and non-GAAP increases were driven primarily by the CDMO business, including the benefit from the divestiture.
Stock Repurchase Update
The Company repurchased 1.7 million shares for a total of $300.0 million during the year-to-date period ended June 27, 2026, including 0.6 million shares for a total of $100.0 million in the second quarter of 2026. As of June 27, 2026, the Company had $700.0 million remaining under its $1.0 billion stock repurchase authorization that was approved by the Board of Directors on October 29, 2025.
2026 Guidance Update
The Company is increasing its 2026 revenue and non-GAAP earnings per share guidance, which was last updated on May 7, 2026. This increase primarily reflects the expected operational outperformance for the year, including in the second quarter, due primarily to improving demand trends in the DSA segment and better-than-expected performance in the Manufacturing segment. For the year, the Company expects the second-quarter investment gains associated with the deferred compensation plan will be largely offset by a higher tax rate, resulting in a negligible net impact to non-GAAP earnings per share.
On a GAAP basis, the Company is reducing its earnings per share guidance due primarily to the net loss related to the divestitures.
The Company’s 2026 guidance for revenue and earnings per share is as follows:
2026 GUIDANCE CURRENT PRIOR
Revenue growth/(decrease), reported (3.5)% – (2.5)%
(5.5)% – (4.0)%
Less: Contribution from acquisitions 0.0% – (0.5)%
0.0% – (0.5)%
Add: Impact from divestitures
~4.5%
~5.0%
Less: Favorable impact of foreign exchange (0.5)% – (1.0)%
(0.5)% – (1.0)%
Revenue growth/(decrease), organic (1)
0.0% – 1.0% (1.5)% – (0.5)%
GAAP EPS estimate $3.05 – $3.35
$5.35 – $5.85
Acquisition-related amortization (2) ~$2.30
~$2.30
Acquisition- and divestiture-related costs (3) ~$4.75
~$2.30
Costs associated with restructuring and efficiency initiatives (4) ~$1.20
~$0.85
Other, net (5) ($0.17)
NM
Non-GAAP EPS estimate $11.15 – $11.45 $10.80 – $11.30

Footnotes to Guidance Table:
(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions, divestitures (including the CDMO and Cell Solutions businesses, as well as certain European Discovery Services sites), as well as foreign currency translation.
(2) These adjustments primarily include amortization related to intangible assets, as well as the purchase accounting step-up on inventory and certain long-term biological assets.
(3) These adjustments include costs related to the evaluation and integration of acquisitions and divestitures, as well as a net loss on divestitures and other transaction-related tax adjustments.
(4) These adjustments primarily include site consolidation (including site transition costs), severance, impairment, third-party consulting and professional services, and other costs related to the Company’s restructuring actions and efficiency initiatives. These adjustments also include gains and/or losses on the sale of certain assets and real estate.
(5) These adjustments primarily include: (i) certain venture capital and other strategic investment losses/(gains), net. This item only includes recognized gains or losses on certain investments. The Company does not forecast the future performance of these investments; and (ii) reductions to a previous $27 million inventory charge associated with an NHP supply matter. As a result of the resolution of the U.S. government investigations during fiscal year 2025, certain NHPs were subsequently utilized.

Webcast
Charles River has scheduled a live webcast on Wednesday, August 5, 2026, at 9:00 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

(Press release, Charles River Laboratories, AUG 5, 2026, View Source [SID1234669720])

On August 5, 2026 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the second quarter of 2026 and recent business highlights.

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"We are executing a focused strategy to build a leading hematology company, which starts with bringing RYTELO to more eligible patients impacted by LR-MDS in the U.S. Our team delivered a third consecutive quarter of RYTELO demand growth, and in the first half of 2026, grew net revenue by 24% while decreasing total operating expenses by 4% compared to the same period last year," said Harout Semerjian, President and Chief Executive Officer of Geron. "With an estimated 8,000 second-line LR-MDS patients in the U.S., we see a meaningful opportunity to continue growing demand for RYTELO in 2026 and beyond. We also have the opportunity to create additional long-term value by expanding access to RYTELO in other geographies, advancing our Phase 3 IMpactMF trial in relapsed/refractory myelofibrosis and pursuing strategic innovation to develop and commercialize new therapies for people living with blood cancers."

Recent Business Highlights

Reported RYTELO net product revenue of $57.5 million in the second quarter of 2026.
Grew RYTELO demand by 5% in the second quarter 2026, compared to the first quarter 2026.
Increased ordering accounts by roughly 8% in the second quarter 2026 to approximately 1,575.
Presented the first real-world evidence study of RYTELO in patients with lower-risk myelodysplastic syndromes (LR-MDS) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. The retrospective portion of the investigator-sponsored study, conducted at the Moffitt Cancer Center, reported safety and clinical efficacy of imetelstat in advanced, heavily transfusion-dependent patients with LR-MDS, including patients with extensive prior therapies and after luspatercept failure. The efficacy, safety and tolerability observed were generally consistent with findings from the Phase 3 IMerge trial in a broader patient population.1
Presented two abstracts studying imetelstat in relapsed/refractory myelofibrosis at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including an updated overall survival analysis from the Phase 2 IMbark trial compared with real-world data.
Broadened the leadership team with the appointment of Chinmaya Rath as Chief Business Officer.

Second Quarter 2026 Financial Results

Cash and Marketable Securities

As of June 30, 2026, Geron had approximately $326.9 million in cash, cash equivalents, restricted cash and marketable securities, compared to $341.0 million as of March 31, 2026, which provides the Company with cash for the foreseeable future.

Net Loss

For the three months ended June 30, 2026, the Company reported a net loss of $16.7 million, or $0.02 per share, compared to $16.4 million, or $0.02 per share, for the three months ended June 30, 2025. The increase in net loss is directly attributable to non-cash inventory-related expenses, which were partially offset by an increase in RYTELO net product revenue for the quarter.

Revenues

Total product revenue, net for the three months ended June 30, 2026, was $57.5 million, compared to $49.0 million for the three months ended June 30, 2025.

Costs and Operating Expenses

Total costs and operating expenses for the three months ended June 30, 2026, were $70.0 million, compared to $61.5 million for the three months ended June 30, 2025. The increase is primarily due to non-cash inventory-related expenses.

Cost of goods sold was approximately $9.2 million for the three months ended June 30, 2026, compared to $1.2 million for the three months ended June 30, 2025, which consisted of costs to manufacture and distribute RYTELO. The increase is primarily due to non-cash inventory-related expenses.

Research and development expenses for the three months ended June 30, 2026, were $22.0 million, compared to $21.7 million for the same period in 2025. The increase in research and development expenses was a result of investments in manufacturing and was partially offset by lower headcount costs from the workforce reduction in December 2025.

Selling, general and administrative expenses for the three months ended June 30, 2026, were $38.9 million, compared to $38.6 million for the same period in 2025. We continue to invest in our RYTELO commercialization strategy while managing lower general and administrative expenses primarily due to a decrease in personnel expense as a result of the workforce reduction in December 2025.

2026 Financial Guidance

For fiscal year 2026, the Company expects RYTELO net product revenue to be in the range of $220 million to $240 million. Geron also expects total operating expenses to be between $230 million and $240 million. Total operating expenses include non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, inventory write-offs, depreciation and amortization.

Based on current operating plans and assumptions, the Company believes that its existing cash, cash equivalents, restricted cash and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.

Conference Call

Geron will host a conference call at 8:00 a.m. ET on Wednesday, August 5, 2026, to discuss business updates and second quarter 2026 financial results.

A live webcast of the conference call will be available on the "Investors & Media" page of the Company’s website at www.geron.com. A replay of the webcast will be archived and available on the Company’s website.

1. Data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress: Komrokji RS, et al. "Real-world Outcomes of Imetelstat: Interrogating Safety, Efficacy and Predictors of Response in Heavily Pretreated Lower-Risk MDS Patients." Poster PF670. June 11-14, 2026, Stockholm, Sweden.

About RYTELO (imetelstat)
RYTELO (imetelstat) is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with lower-risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.

In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.

Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at View Source

(Press release, Geron, AUG 5, 2026, View Source [SID1234669742])