HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), Tubulin inhibitors, ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesDigestive System Disorders+ [4]

Active Indication

Breast CancerEarly Stage Breast CarcinomaMetastatic breast cancer+ [11]

Inactive Indication

Advanced breast cancerAdvanced HER2-Positive Breast CarcinomaAdvanced Malignant Solid Neoplasm+ [16]

Originator Organization

Genentech, Inc.

Active Organization

Hoffmann-La Roche Ltd.DSM Pharmaceuticals, Inc.

Genentech, Inc.

+ [7]

Inactive Organization

Roche Pharma AG

Roche China Holding Ltd.

License Organization

ImmunoGen, Inc.

China Resources Pharmaceutical Commercial Group Co., Ltd.

Roche Holding AG

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (22 Feb 2013),

HER2 Positive Breast Cancer

RegulationBreakthrough Therapy (United States), Fast Track (United States), Priority Review (Australia), Priority Review (China)

Structure/Sequence

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Sequence Code 18481L

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Sequence Code 44772H

Source: *****

162

Clinical Trials associated with ADO-Trastuzumab Emtansine

NCT07578116

/ Not yet recruitingPhase 3IIT

Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

NCT07610616

/ RecruitingNot ApplicableIIT

Study on the Mechanism of ADC Drug Evaluation Based on Immune Co-culture of Lung Cancer Organoids

A case-control study was conducted to evaluate the efficacy and mechanism of action of antibody-drug conjugates (ADCs) in lung cancer, utilizing patient-derived organoid (PDO)-immune co-cultures. Focusing on HER2-positive and TROP2-positive non-small cell lung cancer (NSCLC) cases, ADC candidates were screened for in vitro activity based on organoid-immune interaction models.
Key assessments included:
Tumor killing efficiency, assessed by dose-response relationships; Drug internalization (cellular uptake), as a measure of penetration into cancer cells; Antibody-dependent cellular cytotoxicity (ADCC) and bystander effect, with negative control targets employed to delineate specificity; Single-cell RNA sequencing, to profile transcriptional alterations at single-cell resolution.
Data demonstrated distinct ADC responses correlating with target expression and immune microenvironment features. The integrated approach provided cell-based evidence of ADC potency and revealed mechanistic insights-including immune-mediated cytotoxicity pathways and intracellular trafficking-supporting the rational design of clinical trials. These findings established a foundation for precision immunotherapy strategies and offered a mechanistic rationale for patient selection in HER2/TROP2-positive lung cancer.

Start Date28 Dec 2025

Sponsor / Collaborator

Guangzhou Institute of Respiratory Disease

ChiCTR2500112127

/ RecruitingPhase 2IIT

A Multicenter, Single-Arm Exploratory Clinical Study on the Efficacy and Safety of Herombopag Olamine Tablets in Patients with Breast Cancer Experiencing Thrombocytopenia Induced by T-DM1

Start Date09 Oct 2025

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

[+1]

100 Clinical Results associated with ADO-Trastuzumab Emtansine

100 Translational Medicine associated with ADO-Trastuzumab Emtansine

100 Patents (Medical) associated with ADO-Trastuzumab Emtansine

1,533

Literatures (Medical) associated with ADO-Trastuzumab Emtansine

01 Sep 2026·JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Integrated metabolomics of tumor and plasma reveals local and systemic metabolic responses to T-DM1 therapy

Article

Author: Ye, Hui ; Sang, Hua ; Wang, Guangji ; He, Xiangyu ; Shao, Chang

Comprehensive mapping of drug-induced metabolic alterations is crucial for understanding the mechanisms of targeted therapies. Antibody-drug conjugates (ADCs) such as trastuzumab emtansine (T-DM1) have revolutionized targeted cancer therapy by combining antibody specificity with cytotoxic potency. However, the metabolic reprogramming underlying their therapeutic action and systemic effects remains poorly understood. Here, we applied high-performance liquid chromatography-mass spectrometry (HPLC-MS)-based metabolomics to profile tumor and plasma metabolic alterations in a human epidermal growth factor receptor 2-positive (HER2⁺) xenograft model at 4- and 7-days following T-DM1 treatment, corresponding to the period of pronounced antitumor activity. A total of 32 significantly altered metabolites were identified in tumor tissues, mapping to pathways including tricarboxylic acid (TCA) cycle, pyrimidine metabolism and lipid metabolism, reflecting disruption in energy production and macromolecular biosynthesis. In plasma, 12 significantly altered metabolites were identified, predominantly affecting histidine, glutamine, taurine, tryptophan, and tyrosine metabolism. Integrated analysis further revealed two compartment-specific metabolites-hippuric acid and uric acid-showing opposite trends, with elevated levels in tumors and reduced levels in plasma. These bidirectional changes indicate a metabolic coupling between tumor and circulation, driven by differential utilization and excretion processes during T-DM1 response. Collectively, our findings demonstrate that T-DM1 elicits coordinated local and systemic metabolic reprogramming, providing mechanistic insights into its antitumor activity and the metabolic coupling between tumor and circulation.

01 Aug 2026·BREAST

Tucatinib in patients with HER2-positive advanced/metastatic breast cancer: A systematic literature review of real-world evidence

Review

Author: Blahna, Matthew T ; Harbeck, Nadia ; Müller, Volkmar ; Anders, Carey ; Gligorov, Joseph ; Simon, Sofia ; Zanucco, Emanuele ; Duhoux, Francois P ; LeVasseur, Nathalie ; Criscitiello, Carmen ; Neuberger, Edward ; Bartsch, Rupert ; Lambertini, Matteo ; Foukakis, Theodoros ; Frenel, Jean-Sebastien ; Kaufman, Peter A ; Penault-Llorca, Frédérique ; Okines, Alicia ; Rosé, Christian ; Cameron, David A ; Sanchez-Bayona, Rodrigo ; Curigliano, Giuseppe ; Ciruelos, Eva M

BACKGROUND:

Recent years have seen rapid advances in human epidermal growth factor receptor 2 (HER2)-directed therapies for breast cancer. The shifting therapeutic landscape has presented patients and clinicians with a plethora of effective treatment options, but optimal treatment sequencing can be challenging. Tucatinib is a HER2-selective tyrosine kinase inhibitor that, when given in combination with trastuzumab and capecitabine, has demonstrated survival benefits for patients with HER2-positive (HER2+) metastatic breast cancer (MBC) pretreated with trastuzumab, pertuzumab, and trastuzumab-emtansine. Real-world data, which can supplement knowledge gained from clinical trials, has begun to emerge for tucatinib, but a comprehensive review of these studies has yet to be conducted.

METHODS:

A systematic literature review was conducted to identify studies published between January 2020 and January 2025 that evaluated the effectiveness and safety of tucatinib in routine clinical practice. Studies were eligible for inclusion if they utilized real-world data, involved patients with HER2+ MBC treated with tucatinib in any line of metastatic therapy, and assessed tucatinib's effectiveness, health-related quality of life (QoL), patient-reported outcomes (PROs), or safety.

RESULTS:

Of 468 unique references identified, 12 publications met the inclusion criteria, 3 of which were manuscripts and 9 of which were congress abstracts. Included studies were heterogeneous in sample size, the lines of therapy assessed, and outcomes reported. Tucatinib-based treatment outcomes in the post-trastuzumab deruxtecan (T-DXd) setting and for patients with brain metastases were also reported. Despite variability among studies, outcomes were broadly consistent with clinical trial findings.

CONCLUSION:

Overall, the available real-world evidence supports the clinical effectiveness of tucatinib-based therapies in HER2+ MBC, including heavily pretreated populations, patients with prior exposure to T-DXd, and those with brain metastases. However, gaps remain in the real-world data regarding the safety profile of tucatinib and its impact on health-related quality of life in routine clinical practice.

15 Jul 2026·BIOCONJUGATE CHEMISTRY

Rapid and Efficient Antibody–Drug Conjugate Design Using Mechanistic Bottom-Up Modeling from In Vitro to Human

Article

Author: Sweeney-Lasch, Stanley ; Kolmar, Harald ; Kahl, Jan-Philip ; Hecht, Stefan ; Lindroos, Tatu ; Stein, Judith ; Anderl, Jan ; Kaempffe, Anna ; Krug, Michael

Antibody-drug conjugates (ADCs) are complex molecules, and many fail clinically despite promising preclinical data. Here, a modular, bottom-up modeling strategy employing mechanistic PK-PD models was developed to translate ADC efficacy and toxicity from bench to bedside and to guide ADC design. The models handle various antigens, payloads, and ADCs, validated using six ADCs (Enhertu, Kadcyla, Trodelvy, RC48, RN927C, and Datroway). Using determined cellular distribution of payloads/ADCs, payload killing parameters, and systemic parameters (assay volume, cell doubling time), ADC in vitro potency was predicted with 94.64% accuracy within a 2-fold range. Incorporating ADC and payload pharmacokinetic parameters enables prediction of in vivo efficacy comparable to cell line- and patient-derived xenograft data from the literature. Scaling parameters from mouse to human (PK, tumor volume, and tumor doubling time) led to the reproduction of clinical efficacy trends. Beyond efficacy, the approach predicts key hematologic toxicities such as neutropenia and thrombocytopenia, demonstrated for Kadcyla and Enhertu. Application to the clinically failed RN927C demonstrated how our modeling approach could have flagged issues and enabled suggestions for design modifications to widen the therapeutic window and prevent the clinical failure. In conclusion, our presented modeling strategy delivers accurate efficacy and toxicity translation from in vitro to humans utilizing easily accessible parameters as the foundation and deepens understanding of ADCs and their individual components, thereby supporting ADC design and candidate and patient selection and accelerating ADC development.

237

News (Medical) associated with ADO-Trastuzumab Emtansine

23 Jul 2026

·www.biospace.com

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Group sales were +6% at constant exchange rates (CER) 1 , -2% when reported in CHF and +8% in USD 2 , in the first six months, driven by high demand for innovative medicines and diagnostics. Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers. Diagnostics Division sales were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. Core operating profit was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue; IFRS operating profit was -6% in CHF due to the appreciation of the Swiss franc. Core earnings per share were +9% at CER (-2% in CHF); IFRS diluted earnings per share were -8% in CHF due to the appreciation of the Swiss franc. Highlights: US Priority Reviews for giredestrant in an early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer as well as Gazyva/Gazyvaro in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys US acceptance of a supplemental Biologics License Application for the Lunsumio and Polivy combination for blood cancer and Gazyva/Gazyvaro for systemic lupus erythematosus Positive phase III data on divarasib in lung cancer; presentation of promising data on fenebrutinib in multiple sclerosis (phase III), Gazyva/Gazyvaro in three autoimmune diseases (phase III) and enicepatide (CT-388) and petrelintide in obesity (phase II) Launch of Axelios 1 , a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale EU CE mark for two blood tests: Elecsys pTau217 to detect Alzheimer’s pathology and Elecsys IGRA TB to identify latent tuberculosis infection US approval for Ventana PTEN (SP218) RxDx Assay , the first companion diagnostic to assess the levels of a key protein in prostate cancer Global collaboration agreement with Nurix Therapeutics for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement to acquire PathAI to transform AI-driven diagnostics Outlook for 2026 confirmed. Outlook for 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–June 2026 2025 At CER 1 In CHF In USD Group sales 30,364 30,944 6 -2 8 Pharmaceuticals Division 23,629 23,985 6 -1 8 Diagnostics Division 6,735 6,959 3 -3 6 Core operating profit 11,856 12,010 10 -1 Core EPS – diluted (CHF) 10.85 11.08 9 -2 IFRS operating profit 9,671 10,330 6 -6 Roche CEO Thomas Schinecker : “Our strong momentum continued in the first half of the year, driven by a 6% sales increase at constant exchange rates and significant positive pipeline development. We reported positive phase III data for divarasib , reinforcing its potential as a best-in-class therapy in advanced lung cancer. Our regulatory momentum accelerated significantly as the US FDA granted five Priority Reviews: giredestrant in early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer and Gazyva/Gazyvaro in two autoimmune kidney diseases. In Diagnostics, we reached major milestones with the launch of our transformative, highly cost-effective Axelios 1 sequencing solution, alongside EU CE mark for key diagnostic tests, including the Elecsys pTau217 blood test for Alzheimer’s pathology and the Elecsys IGRA TB blood test, which delivers automated, scalable latent tuberculosis screening to laboratories worldwide. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.” Group results In the first six months of 2026, Roche sales were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue. Core earnings per share were +9% at CER (-2% in CHF). IFRS operating profit was -6% in CHF to CHF 9.7 billion. IFRS diluted earnings per share were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc. Sales in the Pharmaceuticals Division were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth. The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 11.0 billion, an increase of 12% at CER, or 4% in CHF, compared to the first six months of 2025. Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) were CHF 2.6 billion, a decrease of 8% at CER, or 15% in CHF, compared to the first six months of 2025. In the United States , sales were +6% at CER, -3% when reported in CHF, due to continued growth of Xolair, Hemlibra, Polivy (blood cancer) and Tecentriq. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer) as well as the impact of biosimilar erosion on Actemra/RoActemra (rheumatoid arthritis). Sales in Europe were +1% at CER, or -1% when reported in CHF, as demand for Ocrevus, Evrysdi (spinal muscular atrophy) and Phesgo more than offset the impact of lower sales of Actemra/RoActemra due to biosimilar competition and Perjeta because of the conversion of patients to Phesgo. In Japan , sales were +11% at CER, -5% when reported in CHF, mainly due to product supply to third parties, as well as the uptake of Elevidys (Duchenne muscular dystrophy) and continued growth of Lunsumio (blood cancer), Vabysmo and Hemlibra. Sales in the International region were +10% at CER, or +4% when reported in CHF, led by Phesgo, Vabysmo, Hemlibra, Ocrevus and Polivy. In China, sales were -9% at CER, or -12% when reported in CHF, due to the base effect of a severe flu season in 2025 on Xofluza sales. The Diagnostics Division’s sales were +3% at CER, -3% when reported in CHF, to CHF 6.7 billion, driven by growth in demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. This growth more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, -1% when reported in CHF, driven by higher sales of immunodiagnostic products, the clinical chemistry portfolio and molecular solutions. In North America , sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas. Sales in Asia-Pacific were -5% at CER, or -12% when reported in CHF, mainly due to the healthcare pricing reforms in China, partially offset by growth in demand for clinical chemistry and immunodiagnostic products across the rest of the region. In Latin America , sales were +10% at CER, or +5% when reported in CHF. Pharmaceuticals: key developments Compound Milestone Regulatory Gazyva/Gazyvaro Several autoimmune diseases FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN) The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome. pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years. More information: Media Release , 15 July 2026 Enspryng Thyroid eye disease FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED. Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED. TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated. More information: Media Release , 30 June 2026 Lunsumio and Polivy Blood cancer FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL) Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death. People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies. If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment. More information: Media release , 18 June 2026 Tecentriq Colon cancer FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone. Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options. If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery. More information: Media Release , 11 June 2026 Giredestrant Breast cancer FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years. Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III). The FDA has set a Prescription Drug User Fee Act date of 30 November 2026. More information: Media Release , 2 June 2026 Phase III, pivotal and other key read-outs Divarasib Lung cancer Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population. More information: Media Release , 2 July 2026 Fenebrutinib Multiple sclerosis Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS) Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS. Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide. Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS). More information: Media Release , 22 April 2026 Other Alzheimer’s integrated portfolio presentation Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease. New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care. More information: Media Release , 7 July 2026 Nurix Therapeutics collaboration Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies. Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis). Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors. More information: Media Release , 8 June 2026 Obesity portfolio data presentation Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity. Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity. A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option. More information: Media Release , 1 June 2026 Oncology portfolio data presentation Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages. Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease. Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers. More information: Media Release , 19 May 2026 Ophthalmology portfolio data presentation Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden. Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions. More information: Media Release , 30 April 2026 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Pharmaceuticals Division 23,629 23,985 100.0 100.0 6 -1 United States 12,229 12,670 51.8 52.8 6 -3 Europe 4,520 4,566 19.1 19.0 1 -1 Japan 1,360 1,425 5.8 5.9 11 -5 International 5,520 5,324 23.3 22.3 10 4 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus Multiple sclerosis 3,470 7 2,300 2 758 10 - - 412 30 Hemlibra Haemophilia A 2,492 11 1,313 9 502 4 171 9 506 26 Vabysmo Eye diseases (nAMD, DME, RVO) 2,059 8 1,333 1 386 5 75 26 265 65 Tecentriq Cancer immunotherapy 1,704 6 815 9 410 -3 146 -2 333 17 Xolair 3 Chronic hives, food allergies 1,673 27 1,673 27 - - - - - - Perjeta 3 Breast cancer 1,389 -7 551 -11 238 -14 24 -23 576 0 Phesgo Breast cancer 1,318 18 318 0 425 9 88 15 487 47 Actemra/RoActemra 3 RA, COVID-19 1,074 -9 515 -9 238 -21 140 8 181 -3 Evrysdi Spinal muscular atrophy 968 17 323 15 335 17 39 -1 271 25 Kadcyla 3 Breast cancer 916 -6 310 -14 248 -4 39 2 319 3 Polivy Blood cancer 808 20 381 28 128 -18 98 16 201 47 Alecensa Lung cancer 795 6 261 4 126 -4 93 8 315 13 MabThera/Rituxan 3 Blood cancer, RA 609 5 402 14 62 -9 6 -11 139 -10 Activase/TNKase 3 Cardiac diseases 555 11 531 11 - - - - 24 12 Gazyva/Gazyvaro 3 Blood cancer, lupus nephritis 489 7 240 4 117 -1 17 14 115 21 Herceptin 3 Breast and gastric cancer 462 -12 94 -14 136 -7 2 -36 230 -14 Avastin 3 Various cancer types 414 -15 125 -12 35 37 36 -44 218 -13 Pulmozyme 3 Cystic fibrosis 204 -8 145 -5 29 -11 - 26 30 -18 Columvi Blood cancer 196 70 91 28 53 116 - - 52 173 Enspryng Acute inflammation of brain, spinal cord and optic nerves 195 22 50 20 23 20 79 18 43 37 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone cobas HDV test Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available. More information: Media Release , 14 July 2026 Elecsys IGRA TB test Roche receives CE mark for blood test to identify tuberculosis infection The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions. The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient. More information: Media Release , 9 July 2026 Axelios 1 sequencing platform Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications. Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours. The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future. More information: Media Release , 29 June 2026 Ventana PTEN (SP218) RxDx Assay Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments. The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes. More information: Media Release , 12 June 2026 Liver Disease Panel Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management. The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis. With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer. More information: Media Release , 27 May 2026 Elecsys pTau217 test Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217) Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world. More information: Media Release , 12 May 2026 PathAI agreement Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency. Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools. These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients. More information: Media Release , 7 May 2026 Diagnostics sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Diagnostics Division 6,735 6,959 100.0 100.0 3 -3 Customer areas Core Lab 3,756 3,839 55.8 55.2 4 -2 Molecular Lab 1,196 1,250 17.7 18.0 3 -4 Near Patient Care 909 1,018 13.5 14.6 -5 -11 Pathology Lab 874 852 13.0 12.2 11 3 Regions Europe, Middle East, Africa 2,466 2,485 36.6 35.7 3 -1 North America 2,211 2,235 32.8 32.1 8 -1 Asia-Pacific 1,522 1,729 22.6 24.9 -5 -12 Latin America 536 510 8.0 7.3 10 5 More information on Roche’s performance in the first six months of 2026: Half-Year 2026 Presentation Half-Year 2026 Presentation with appendix Half-Year 2026 Finance Report Appendix with tables About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025. [2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies. [3] Products launched before 2015. Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Irène Stephan Phone: +41 79 377 83 75 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media & Investor Release Roche HY 2026 EN Communications appendix tables_HY_Results_13072026

Clinical ResultPhase 2Phase 3Drug Approval

20 Jul 2026

·www.biospace.com

Greenwich LifeSciences Provides Clinical Updates on FLAMINGO-01

STAFFORD, Texas, July 20, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following clinical updates on FLAMINGO-01. FLAMINGO-01 Data Safety Monitoring Board (DSMB) The FLAMINGO-01 DSMB met in May 2026 and recommended the study continue as is without modification. FLAMINGO-01 Steering Committee Clinical Strategy ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); On December 22, 2025, the company announced the following objectives: "The Steering Committee also met at SABCS 2025 and discussed the clinical strategy, endorsing the planned modifications to FLAMINGO-01. The planned modifications subject to regulatory approval include: increasing the size of the study, which would increase the power of the study thus decreasing the risk by designing the study to assume more recurrences even though fewer recurrences may be anticipated and observed, doubling or quadrupling the enrollment rate, which will increase the patient years in the study more rapidly thus proportionately increase the event rate, which may shorten the time to reach an interim analysis or milestone, continuing to enroll past the interim analyses so that the current momentum at the clinical sites continues, using the interim analysis to potentially resize the study or to change the subsequent interim analysis, to change the number of events triggering an analysis, or to change the timing of the study based on recommendations by an independent committee, and using a recently manufactured GP2 commercial drug product lot in FLAMINGO-01" CEO Snehal Patel commented, "We are pleased to announce that following review by FDA and EMA regulatory authorities that these objectives have been met and that FLAMINGO-01 now has the hallmarks of a large pharma Phase III clinical trial. The study is now designed and sized to improve the probability of success, to attract the interest of sophisticated investors and pharma companies, and to maximize the chances that the Company could BLA after interim analysis 1, after interim analysis 2, or after the end of the study." Mr. Patel further added, "The transition is now underway globally at all sites. We have provided below in this press release the details of the study design reviewed by both the US and EU agencies, and currently subject to review by the UK and Canada, and will be updating the Company website and presentation, and videos accordingly. These agencies may provide additional recommendations or requirements at any time and we remain flexible to accommodate their advice as needed." The Company plans to now leverage the increased enrollment rate resulting from the combination of all HLA types together with the following: 1) the very high interest from patients and clinicians which has led to almost 200 clinical trial sites in the US and Europe, 2) the clinical operational capability in place 3) the currently trending low event rate, and 4) the efficient cost structure and burn rate that the Company has successfully funded through small capital raises. Enrollment Rate into the Blinded Arm As previously disclosed, all European and US Sites will combine all new patients independent of HLA type in the randomized arms of FLAMINGO-01. Non-HLA-A*02 patients who represent about 55% of the population and were on waiting lists for up to a year are now eligible for enrollment, which could provide for the rapid enrollment of up to 300 patients. This protocol amendment will more than double the enrollment rate increasing it by 122% or resulting in a 2.22x faster enrollment rate (55%/45% = 122%), which proportionately increases the event rate. This more than doubling of the event rate, provides an opportunity to derisk the study and provide multiple pathways to filing a BLA in the US with much higher probabilities of success at each opportunity for analysis. Leveraging the High Interest from Patients and Clinicians The Company has achieved a major milestone by screening over 1,500 patients in Flamingo-01, continuing its screening rate of approximately 150-200 patients per quarter or the equivalent of 600-800 patients per year in approximately 170-180 sites. The 11 participating countries include: US, Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and Austria. The Company is planning to add the following additional European countries due to interest from principal investigators and patients: Norway, Denmark, and Sweden in addition to the UK and Canada. Rationale to Keep Enrollment Open Until Interim Analyses In the double-blinded arms of the Phase III trial, the originally designed 500 HLA-A*02 patients were likely to be filled before the interim analysis and thus the clinical sites would have had to stop enrolling. If the interim analysis suggested that more patients should be enrolled, restarting enrollment would have been very difficult. A 2.22x increase in the enrollment rate without any other modifications would have accelerated the stopping of enrollment, but the probability of a successful data analysis at the interim analysis and the filing of BLA would not be increased. It isn't in the study's best interest to wait for more events without the option to continue enrolling to increase the event rate. It is optimal to keep enrolling while collecting events because even patients in the study for only a short time are at risk of recurrence and can add information to analyses. Capital Raising Strategy Has Kept up with Modestly Increasing Burn Rate The cash burn will be manageable as in the past due to the efficiently run and internalized clinical operations. The manufacturing of GP2 vials for the Phase III clinical trial has been completed with sufficient vials to treat all patients. Most of the start-up costs for the clinical sites have been paid. Many patients have entered the booster phase with 2 vaccinations per year with lower costs thus offsetting the higher costs for patients entering the study, when 6 vaccinations in the first 6 months during the primary immunization series are required. The Company's annual burn rate was approximately $7 million in 2024 and 2023 and $10 million in 2025. The income statements for these periods have been reported as much higher losses, but the cash flow used for operations is much lower due to the non-cash stock and options expenses added to the income statements. For the second quarter of 2026, the burn rate is expected to be approximately $2 million versus a $4.7 million burn rate in the first quarter of 2026, leading to a Q2 2026 cash balance of approximately $8.9 million as of June 30, 2026 and an expected burn rate of $2-4 million per quarter going forward. The above preliminary financial figures are unaudited and are subject to change following completion of the Company's financial review for Q2 2026. This capital raising strategy may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities. Improved Trial Design Allows for Substantial Reduction in Risk In the double-blinded arms of the Phase III trial, the trial has been designed to detect a hazard ratio (HR) of 0.55 in invasive breast cancer-free survival, where 28 events will be required for the 1 st interim analysis, 56 events will be required for the 2 nd interim analysis, and 133 events will be required to end the study. Interim analyses for superiority and futility will be conducted and, if successful, could lead to the filing of a BLA in the US at those times. The number of patients enrolled in the study will depend on the event rate and thus enrollment may continue for as long as necessary up to a maximum of 2,000 patients. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater and the HR is 0.55. In addition, the number of events may be adapted by the DSMB based on interim analyses. By doubling the number of events to trigger an interim and increasing the HR, which is offset by the more than doubling event rate due to the higher enrollment rate, and may or may not alter time lines, the probability of a positive study outcome can be increased substantially. An increase of the HR puts FLAMINGO-01 more in line with other prominent large pharma breast cancer Phase III clinical trials such as Katherine for Kadcyla and Destiny Breast-05 for Enhertu. The HR is equal to one minus the percent reduction in events caused by the treatment arm. For example, an HR = 0.3 would suggest a 70% reduction in events and an HR = 0.75 would suggest a 25% reduction in events by the treatment arm. The Katherine study which compared Kadcyla to Herceptin breast cancer treatment in the adjuvant setting after surgery in the residual disease population assumed a design HR = 0.75 but realized a lower study result HR at the first interim of 0.5, which led to a sufficiently low p value and strong enough statistical significance to warrant approval for Kadcyla in the adjuvant setting following submission of interim data to the FDA. Approximately 1,486 patients were enrolled, 256 events were observed at the interim analysis, and 385 events were observed at the final analysis. The Destiny Breast-05 study which compared Enhertu to Kadcyla breast cancer treatment in the adjuvant setting after surgery, in a higher risk residual disease population than Katherine, assumed a design HR = 0.675 but realized a lower study result HR at the first interim of 0.5, which led to a sufficiently low p value and strong enough statistical significance to warrant approval for Enhertu in the adjuvant setting following submission of interim data to the FDA. Approximately 1,635 patients were enrolled and 153 events were observed at the interim analysis. GLSI-100 by contrast has shown a study result HR = 0.2 in the Phase IIb clinical trial for HLA-A*02 patients. In the 250 patient non-HLA-A*02 open label arm of FLAMINGO-01, which is now fully enrolled and where all patients received GLSI-100, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate or a HR = 0.2-0.3 when calculated by various methods. This data is early and will continue to mature over time. This low event rate is supported by immune response data that was recently published at AACR and ASCO conferences in 2026. The section below, "About FLAMINGO-01 Open Label Phase III Data", summarizes these results and provides links to the posters at the conferences. By increasing the original FLAMINGO-01 trial design HR = 0.3 to a design HR = 0.55 and by doubling the events required to trigger the first interim analysis from 14 to 28 events, the probability of success or power at the first interim analysis, if a lower study result HR = 0.3 is realized, increases from less than 20% to more than 85%. This increase in power at the first interim, when the study result HR is lower than the design HR, is possible due to the combination of both HLA types, while the more than double event rate at 2.22x offsets the doubling of the events required to trigger this first interim analysis. Effectively increasing the probability of filing a BLA at the first interim analysis from 20% to 85% justifies the study design changes. Additional benefits of the new design include: The first interim results may affect or alter the design of the second interim. Endpoints can be analyzed by individual HLA types as well as one combined group of all HLA types and given that each patient has 2 HLA-A alleles, one from each parent, there are multiple analyses that can be conducted. Doubling the market for GLSI-100 to potentially $10 billion in revenue per year by accelerating the clinical development of the non-HLA-A*02 population. Capital raise requirements are still modest, based on the Company's disciplined operations and low burn rate. About FLAMINGO-01 Open Label Phase III Data More than 1,500 patients have been screened at a screen rate of approximately 600-800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection. In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate. The non-HLA-A*02 arm is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products. The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety pro non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study. The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO Meeting 2026 injection site reaction (ISR) poster can be seen and downloaded at the bottom of the Phase III clinical trial tab on the Company's website here . As shown in both posters the frequency of DTH and ISR reactions increased statistically significantly over time. As reported in Table 1 of each poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline. Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated. Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ. About GLSI-100 Phase IIb Study In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb posters and results can be summarized as follows and can be seen here : 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 170-180 sites globally. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here . Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to:  flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/ neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime. In the US and Europe, there are approximately 700,000 new breast cancer patients per year and 9.5 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at and follow the Company's Twitter at . Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company Contact Snehal Patel Investor Relations Office: (832) 819-3232 Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com

Phase 2Clinical ResultPhase 3

29 Jun 2026

·www.biospace.com

VivoSim Presents Data Showing Superiority to Competition in NAM Liver Tox Prediction at European Toxicology Meeting

VivoSim Demonstrates Leadership in Field through AI-enabled NAMkind™ Liver and Intestine with High Accuracy Results, Including for Antibody Drug Conjugates (ADCs) SAN DIEGO, June 29, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAMs) for preclinical safety, today announced that data demonstrating the power of its advanced 3D human tissue models will be featured in two presentations at the European Society of Toxicology’s annual conference. The presentations collectively showcase the best-in-industry predictive power of VivoSim's proprietary AI-enabled NAMkind™ Liver and NAMkind™ GI platforms. In liver toxicology testing, across a set of compounds where animal models and traditional methods provide 50-65% sensitivity, VivoSim’s models provided >90% sensitivity at detecting true positives for liver toxicity. Whereas current methodologies including animal in vivo testing can result in >10% false positives (wrongly predicted to have liver tox when they do not, causing rejection of a viable drug candidate), VivoSim’s liver toxicology methods result in fewer than 5% false positives. These powerful results help VivoSim clients avoid expensive mistakes in drug development, at a time when the industry is undergoing a shift in preclinical safety evaluation. "With a heavy push from the US FDA, the pharmaceutical industry is moving away from traditional animal testing toward high-fidelity, human-relevant alternatives," said Keith Murphy, VivoSim Executive Chairman. "As our newest data show, using AI-informed models in highly accurate tissues, we detect the problems that pharma typically misses. When a pharma has a miss, the cost to them is many lost years and $50M - $200M, so strategic-thinking pharma executives are taking notice of the availability of better tools." The United States Food and Drug Administration (FDA) is actively encouraging human-relevant NAMs in place of animal studies, a push that is resulting in greater pharma demand for new technologies. After presenting its April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies, the FDA recently reported that it is meeting its goals for stimulating pharma uptake of these new models. VivoSim’s novel models offer perhaps the most predictive tool to make FDA’s vision a reality. VivoSim’s superior results are achieved by a combination of the best biological model with the most representative primary human cell types, leveraging multiple endpoints as readouts for best prediction, and training AI prediction models with multiple endpoints that provide a rich data set, yielding high prediction accuracy. In addition to testing traditional oral pill small molecules, VivoSim is establishing competitive advantages across new biotech modalities such as antibodies, siRNA, and gene therapies. Adding to the data supporting its industry leadership in small molecules as outlined above, the company has done extensive testing of Antibody Drug Conjugates (ADCs), one of oncology’s fastest-growing modalities, with comparable accuracy results in terms of predicting the clinical profiles of ADCs for liver toxicity and diarrhea. Globally, hundreds of ADC candidates are now in active clinical development against over 50 molecular targets — 41 of them already in Phase III — and the pipeline remains overwhelmingly oncology-focused, led by HER2- and TROP2-directed programs in breast and lung cancer. Therapies still fail in human trials, most often on safety or efficacy. VivoSim’s mission is to close gaps in the ability to predict outcomes before a drug enters expensive clinical trials. “These results show our human-relevant models let developers move from detecting liabilities to predicting risk,” said Amar Sethi, MD, PhD, Chief Scientific Officer of VivoSim. “Whether we are unraveling the cause of TKI-induced diarrhea or guiding the design of safer, more effective ADC linker-payload combinations, our multi-endpoint profiling gives teams the translational signatures they need to retire toxic liabilities long before a single patient is dosed.” Overall, the findings show that the Company’s human-relevant models can predict liver and gastrointestinal toxicity — for both traditional small molecules and complex antibody-drug conjugates (ADCs) — with accuracy that tracks real clinical outcomes. The data are being presented at The 23rd International Congress of the European Society of Toxicology In Vitro (ESTIV 2026) in Maastricht, the Netherlands, which takes place from June 29 to July 2, 2026. Key highlights of the presented data demonstrating VivoSim’s ability to achieve definitive translational signatures across complex organ systems: High-Accuracy Liver Profiling: Benchmarked against a clinical small-molecule dataset of 92 compounds, the NAMkind™ Liver spheroid model achieved a predictive accuracy of 91%, with 90% sensitivity, 95% specificity, and 99% precision under repeat-dose conditions. The multi-endpoint profiling suite effectively minimized false negatives and successfully resolved intra-class toxicities, such as within thiazolidinediones (TZDs). Mechanistic GI Insights: Using the multicellular human intestinal barrier model (NAMkind™ GI), VivoSim successfully integrated multiple endpoints including barrier function to resolve distinct mechanistic classes of tyrosine kinase inhibitor (TKI)-induced diarrhea. Deconvolution of ADC Toxicity: Critically, both platforms demonstrated a unique capacity to evaluate advanced modalities by differentiating ADC risk based on structural properties. The GI model established that Trastuzumab-deruxtecan-mediated injury is exposure-dependent and payload-driven through detailed histological tracking. Meanwhile, the Liver model successfully differentiated hepatic risk based on linker stability and payload permeability when comparing Trastuzumab Emtansine and Trastuzumab Deruxtecan. About VivoSim Labs VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) announcement on April 10, 2025 to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit Forward-Looking Statements Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding NAMKind™, including target turnaround time and its potential to help users de-risk their pipelines, avoid costly downstream failures, reduce rework, prioritize the right assets, move faster, save millions and reduce risk; VivoSim’s commercial presence across Asia-Pacific; the evaluation and acceptance of scientifically robust NAM-based evidence; the Company’s ability to capture growing demand in the in vitro toxicology testing market; demand for human-relevant toxicology; the market opportunity and market size of gastrointestinal in vitro models and toxicology services; and the Company’s scaling capacity to support expanding global demand and development needs. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 11, 2026. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. Contact(s): Investor Relations info@vivosim.ai VivoSim Labs, Inc.

Phase 3Clinical ResultADC

100 Deals associated with ADO-Trastuzumab Emtansine

External Link

KEGG	Wiki	ATC	Drug Bank
-	ADO-Trastuzumab Emtansine	L01XC14	DB05773

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Breast Cancer	China	Roche Pharma (Schweiz) AG	21 Jan 2020
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	15 Nov 2013
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	15 Nov 2013
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	15 Nov 2013
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	European Union	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	Iceland	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	Liechtenstein	Roche Registration GmbH	15 Nov 2013
Metastatic breast cancer	Norway	Roche Registration GmbH	15 Nov 2013
HER2 Positive Breast Cancer	United States	Genentech, Inc.	22 Feb 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	Phase 3	United States	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	China	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Japan	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Argentina	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Belgium	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Brazil	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Canada	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Czechia	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	Finland	Hoffmann-La Roche, Inc.	03 Sep 2012
Gastroesophageal junction adenocarcinoma	Phase 3	France	Hoffmann-La Roche, Inc.	03 Sep 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2-positive	187	T-DM1	gxrkwibwlq(ddvzzpesgn) = jlwqphovns iiqfydrceh (xjhahxhgeu, 95 - 100)	Positive	29 May 2026
ESMO_BC2026	Not Applicable	HER2 Positive Breast Cancer HER2-positive	270	Biosimilar T-DM1 (Overall)	trogymaufs(oamwnekbkx) = dtebuafsix rixxqrpair (loqysudksk ) View more	Positive	07 May 2026
ESMO_BC2026	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2-positive	187	T-DM1	bfqygxmthc(zwhmaoupey) = mzybfavhmy lccrpqkcyu (ywsqwkpkrz, 95 - 100)	Positive	07 May 2026
NCT02568839 (PREDIX HER2, ESMO_BC2026)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	164	docetaxel+trastuzumab+pertuzumab (DHP)	xpjaqsugrx(pjodelxnky) = tjmzwxohtx oacmupahqp (ybddjhzivu )	Positive	07 May 2026
NCT02568839 (PREDIX HER2, ESMO_BC2026)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	164	docetaxel+trastuzumab+pertuzumab (HER2-enriched (HER2-E))	xpjaqsugrx(pjodelxnky) = gwiwxhznto oacmupahqp (ybddjhzivu )	Positive	07 May 2026
NCT03587740 (CTgov)	Phase 2	HER2 Positive Breast Cancer	111	T-DM1	uzswrahcmz = ecngpsvrox soelyspiuu (ycnmzonmga, saynzuutml - emupfaautd) View more	-	29 Apr 2026
ESMO_TAT2026	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	101	T-DM1 Biosimilar Ujvira (metastatic)	fvnnaeekzu(gummrbmaod) = infrequent cdpwxtllzh (fhezjbloqw ) View more	Positive	16 Mar 2026
SABCS2025	Not Applicable	Metastatic breast cancer HER2-positive	22	T-DM1	ykxqjjruif(eoevakyqas) = associated with shorter OS (HR: 3.05), PFS (HR:4.30), and TTP (HR: 5.30) gznuebridn (nfouxlnbbp )	Negative	12 Dec 2025
JPRN-jRCT2031210436 (ESMO2025)	Phase 2	Extramammary Paget Disease HER2-positive	14	T-DM1 3.6 mg/kg	brbjthsgbd(wqfbefqccf) = sfpihasfxd vszewkfktu (vxrxleejnj, 57.2 - 98.2)	Positive	17 Oct 2025
NCT04744831 \| NCT03418558 \| NCT03384940 (RHEA, ESMO_GI2025) Manual	Phase 2	HER2 Positive Colorectal Cancer HER2 Positive	26	TDM-1 or trastuzumab-deruxtecan or trastuzumab/lapatinib or trastuzumab/pertuzumab or pertuzumab/TDM-1	kjvhprskcx(nljdznyyul) = qzgjcieisa inhqsypbhq (krueyqbyrt ) View more	Positive	03 Jul 2025
ASCO2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast	421	Concurrent ADCs with RT (C-ADC)	vpcvpjjzfz(grljfgltve) = C-ADC is associated with a significantly higher risk of SRN ncrjyvnopa (qxmkurprja ) View more	Negative	30 May 2025
ASCO2025	Not Applicable		421	Non-concurrent ADCs with RT (NC-ADC)		Negative	30 May 2025

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