On July 22, 2026 argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, reported its half year 2026 results and provided a second quarter business update.

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"Our strong second quarter performance reflects continued execution of our Vision 2030 strategy and our commitment to accelerate immunology innovation," said Karen Massey, Chief Executive Officer. "During the quarter, we further strengthened our leadership in FcRn with the launch of the expanded label for VYVGART and VYVGART Hytrulo to now include all gMG serotypes, providing physicians with a single treatment option for the broadest adult gMG patient population. With important registrational study readouts in the second half, as well as continued progress with our early-stage pipeline, we are advancing the next wave of innovation, reinforcing our ambition to build a leading multi-asset immunology company."

Vision 2030
argenx continues to advance its ‘Vision 2030’ anchored in the ambition to treat 50,000 patients globally with its medicines, secure 10 labeled indications, and progress five pipeline candidates into registrational development by 2030.

Expanding global VYVGART opportunity and shaping the long-term future of FcRn
VYVGART (IV: efgartigimod alfa-fcab; SC: efgartigimod alfa and hyaluronidase-qvfc) is the first-and-only approved treatment for all serotypes of adult patients living with generalized myasthenia gravis (gMG). It is also approved for chronic inflammatory demyelinating polyneuropathy (CIDP) globally, and primary immune thrombocytopenia (ITP) in Japan. As the leading targeted biologic in MG and CIDP, argenx is progressing multiple label expansions while building the future of FcRn by advancing novel FcRn pipeline candidates and new delivery modalities.

Generated $1.5 billion in global product net sales in the second quarter of 2026, representing 17% quarter-over-quarter growth, and a year-over-year increase of 60% or $0.6 billion
Launched expanded label for VYVGART and VYVGART Hytrulo in the U.S., which now includes all gMG serotypes (anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative)
On track with plans to expand VYVGART into ocular myasthenia gravis (oMG) following positive ADAPT OCULUS results
Topline results from registrational ALKIVIA study (myositis) expected in third quarter of 2026
Topline results from registrational ADVANCE-NEXT study (primary ITP) expected in first half of 2027
Topline results from registrational UNITY study (Sjogren’s disease) expected in second half of 2027
Registrational study in Graves’ disease (GD) ongoing, expanding development into thyroid-driven autoimmunity
VYVGART SC autoinjector positioned to launch in 2027 for all approved indications
Progressing two future FcRn molecules: ARGX-213, designed for monthly dosing, is Phase 3 ready, and ARGX-124 is expected to complete Phase 1 evaluation by end of 2026

Advancing empasiprubart, argenx’s second pipeline-in-a-product opportunity
Empasiprubart (anti-C2) is argenx’s second pipeline-in-a-product opportunity and is being evaluated in registrational studies in multifocal motor neuropathy (MMN) and CIDP, and in a combination study with VYVGART in gMG.

Topline results from registrational EMPASSION study (MMN) expected in fourth quarter of 2026
Topline results from registrational EMVIGORATE and EMNERGIZE studies (CIDP) expected in second half of 2027
Data from Phase 2 VARVARA study (delayed graft function, DGF) support further evaluation of empasiprubart in transplant setting based on signal at 52 weeks
Advancing ADAPT-Forward combination study, evaluating empasiprubart as a potential add-on therapy to efgartigimod in gMG
Delivering next wave of immunology innovation
By the end of 2026, argenx expects to have ten molecules in clinical development across its immunology pipeline, including adimanebart (MuSK agonist), ARGX-121 (anti-IgA), ARGX-109 (anti-IL-6) and additional candidates emerging from the Immunology Innovation Program. Together, these programs support argenx’s goal of building a durable pipeline of differentiated medicines.

Phase 2 study of adimanebart in spinal muscular atrophy (SMA) ongoing; registrational study in congenital myasthenic syndromes (CMS) expected to begin in 2026
Phase 2 study of ARGX-121 in IgA nephropathy (IgAN) expected to start in 2026
First-in-human Phase 1 study of TSP-101 (Fn14 inhibitor) is ongoing
ARGX-118 (Galectin-10 inhibitor) and ARGX-125 (first-in-class bispecific antibody against an undisclosed target) are on track to enter Phase 1 studies in 2026
SECOND QUARTER 2026 FINANCIAL RESULTS
argenx SE
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS

Three Months Ended Six Months Ended
30 June, 30 June,
(in millions of $ except per share data) 2026 2025 2026 2025
Product net sales $ 1,516 $ 949 $ 2,813 $ 1,739
Other operating income 26 19 41 36
Total operating income $ 1,542 $ 967 $ 2,854 $ 1,775

Cost of sales $ (145) $ (111) $ (266) $ (192)
Research and development expenses* (486) (330) (929) (642)
Selling, general and administrative expenses (417) (325) (772) (601)
Total operating expenses $ (1,048) $ (766) $ (1,967) $ (1,435)

Operating profit $ 494 $ 201 $ 887 $ 340

Financial income $ 48 $ 38 $ 92 $ 76
Financial expense (1) (1) (2) (2)
Exchange (losses)/gains (8) 49 (19) 76

Profit for the period before taxes $ 532 $ 287 $ 958 $ 489
Income tax expense $ (59) $ (42) $ (119) $ (74)
Profit for the period $ 472 $ 245 $ 838 $ 415
Profit for the period attributable to:
Owners of the parent $ 472 $ 245 $ 838 $ 415
Weighted average number of shares used for basic profit per share 62,312,606 61,084,250 62,185,445 61,034,202
Basic profit per share (in $) 7.58 4.02 13.47 6.80
Weighted average number of shares used for diluted profit per share 64,524,979 65,639,446 64,409,488 65,653,007
Diluted profit per share (in $) 7.32 3.74 13.00 6.32
*Comparative figures have been aligned with the presentation adopted in the current period, reflecting the combination of research and development expenses and loss from investment in a joint venture.

DETAILS OF THE FINANCIAL RESULTS

Total operating income for the three and six months ended June 30, 2026, was $1.5 billion and $2.9 billion, respectively, compared to $1.0 billion and $1.8 billion, respectively, for the same periods in 2025, and mainly consists of:

Product net sales of VYVGART for the three and six months ended June 30, 2026, were $1.5 billion and $2.8 billion, respectively, compared to $0.9 billion and $1.7 billion, respectively, for the same periods in 2025.

Other operating income for the three and six months ended June 30, 2026, was $26 million and $41 million, respectively, compared to $19 million and $36 million, respectively, for the same periods in 2025. The other operating income for the three and six months ended June 30, 2026 and 2025, primarily relates to research and development tax incentives and payroll tax rebates.

Total operating expenses for the three and six months ended June 30, 2026 were $1.0 billion and $2.0 billion, respectively, compared to $0.8 billion and $1.4 billion, respectively, for the same periods in 2025, and mainly consist of:

Cost of sales for the three and six months ended June 30, 2026, was $145 million and $266 million, respectively, compared to $111 million and $192 million for the same periods in 2025, respectively. The cost of sales was related to the sale of VYVGART.
Research and development expenses for the three and six months ended June 30, 2026, were $0.5 billion and $0.9 billion, respectively, compared to $0.3 billion and $0.6 billion, respectively, for the same periods in 2025. The research and development expenses mainly relate to advancing efgartigimod, empasiprubart, and adimanebart across multiple registrational studies, plus early-stage pipeline and preclinical programs.
Selling, general and administrative expenses for the three and six months ended June 30, 2026, were $0.4 billion and $0.8 billion, respectively, compared to $0.3 billion and $0.6 billion, respectively, for the same periods in 2025. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the global commercialization of the VYVGART franchise, and personnel expenses.

Financial income for the three and six months ended June 30, 2026, was $48 million and $92 million, respectively, compared to $38 million and $76 million, respectively, for the same periods in 2025.

Income tax for the three and six months ended June 30, 2026 and 2025 is detailed below:

Three Months Ended Six Months Ended
30 June, 30 June,
(in millions of $) 2026 2025 2026 2025
Current tax expense $ (128) $ (41) $ (230) $ (70)
Deferred tax benefit/(expense) 68 (1) 110 (4)
Income tax expense $ (59) $ (42) $ (119) $ (74)
Profit for the three and six-month periods ended June 30, 2026, was $0.5 billion and $0.8 billion, respectively, compared to a profit of $0.2 billion and a loss of $0.4 billion, respectively, for the same periods in 2025. The basic profit per share was $7.58 for the three months ended June 30, 2026, compared to a basic profit per share of $4.02 for the same period in 2025. The basic profit per share was $13.47 for the six months ended June 30, 2026, compared to a basic loss per share of $6.80 for the same period in 2025.

Cash flow from operating activities for the six months ended June 30, 2026 was $0.7 billion compared to a cash flow used in operating activities for the same period in 2025 of $0.4 billion.

Cash, cash equivalents and current financial assets1 consisted of $3.6 billion in cash, cash equivalents and $1.6 billion in current financial assets which totaled $5.2 billion as of June 30, 2026, compared to $3.5 billion in cash and cash equivalents and $0.9 billion in current financial assets which totaled $4.4 billion as of December 31, 2025.

EXPECTED FINANCIAL CALENDAR

October 22, 2026: Third Quarter 2026 Financial Results and Business Update
February 25, 2027: Full-year 2026 Financial Results and Fourth Quarter 2026 Business Update
CONFERENCE CALL DETAILS
The half-year 2026 financial results and second quarter business update will be discussed during a conference call and webcast presentation today at 2:30 PM CET/8:30 AM ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors.

Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below:

Belgium 32 2290 4635
France 33 172 001717
Netherlands 31 20 795 2683
United Kingdom 44 203 393 1560
Japan 81 3 4520 9761
Switzerland 41 43 210 51 68

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

A replay of the webcast will be available on the argenx website.

About VYVGART
VYVGART (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.

(Press release, argenx, JUL 22, 2026, View Source [SID1234669371])

On July 22, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that the first patient has been dosed in the TARGET-D 202 Phase 2 registration-directed trial evaluating VS-7375, an investigational oral KRAS G12D (ON/OFF) inhibitor, in patients with previously treated KRAS G12D-mutated advanced non-small cell lung cancer (NSCLC). The initiation of TARGET-D 202 marks the second registration-directed Phase 2 clinical trial now underway for VS-7375, following first-patient dosing in the TARGET-D 201 metastatic pancreatic cancer study announced last month.

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"Despite advances in RAS-targeted therapies, there are no FDA-approved therapies specifically designed to target KRAS G12D-mutated tumors. Among the many challenges facing patients with KRAS G12D-mutated lung cancer, they continue to experience some of the poorest outcomes with progression-free survival of approximately 11 months – shorter than those with other common KRAS mutations," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology. "We’re making significant progress with the TARGET-D clinical trial programs, and once the first patient is dosed in the TARGET-D 203 Phase 2 study for advanced metastatic colorectal cancer, we will have registration-directed trials underway across the three most common KRAS G12D-driven tumor types. We believe we are well positioned to advance the broad clinical development of VS-7375 across multiple tumor types to selectively target KRAS G12D to maximize efficacy, allow for tolerable combinations, and avoid toxicities problematic with non-specific pan-RAS inhibitors."

TARGET-D 202 (NCT07659782) is a global, open-label, Phase 2 registration-directed trial evaluating VS-7375 monotherapy at the recommended Phase 2 dose (RP2D) of 900 mg daily (QD) in patients with unresectable locally advanced or metastatic KRAS G12D-mutated NSCLC whose disease has progressed following prior treatment with platinum-based chemotherapy and an anti-PD-(1) therapy. The trial is designed to evaluate the efficacy and safety of VS-7375 and support a potential registration strategy in this patient population. A cohort in the study will also evaluate VS-7375 in non-small cell lung cancer patients with asymptomatic untreated brain metastases.

In June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic ductal carcinoma (mPDAC), metastatic colorectal cancer (mCRC), NSCLC, and other solid tumor cancers. In a recent update, the Company shared that VS-7375 demonstrated encouraging anti-tumor activity across multiple KRAS G12D-driven tumor types, including mPDAC, mCRC, and advanced NSCLC, with evidence of dose-dependent activity, favorable PK supporting target exposure, and a favorable and manageable safety and tolerability profile. Patient follow-up continues to mature across monotherapy and combination cohorts, and the Company expects to share an update in the second half of 2026.

About Non-Small Cell Lung Cancer

Lung cancer remains the leading cause of cancer-related death worldwide, with non-small cell lung cancer (NSCLC) accounting for approximately 80–85% of all lung cancer diagnoses. Approximately 10,000 patients with NSCLC harbor a KRAS G12D mutation in the U.S. annually. Compared with other KRAS mutation variants, metastatic KRAS G12D NSCLC is associated with the shortest progression-free survival and has been linked to immune suppression and resistance to anti-PD-(L)1 therapies. KRAS G12D is the most common KRAS mutation among never-smokers, while also occurring in many patients with a history of smoking. Additionally, brain metastases remain a significant clinical challenge in metastatic NSCLC, affecting approximately 10–20% of patients at diagnosis and up to 40% during the course of disease. Despite these challenges and the significant unmet medical need, there are currently no approved therapies specifically targeting KRAS G12D-mutated NSCLC.

About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. When the KRAS gene is mutated, it can promote cancer development and growth. Patients with KRAS G12D-mutant tumors often have poorer outcomes, underscoring the need for therapies designed specifically to inhibit this mutation potently and for a long duration. The KRAS G12D mutation occurs most commonly in pancreatic (40%), colorectal (15%), endometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & TARGET-D Clinical Program

VS-7375 is a potential best-in-class, potent, and selective investigational oral KRAS G12D dual ON/OFF inhibitor. It is designed to uniquely bind to both the active (ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit KRAS G12D signaling and tumor growth more completely than compounds that block KRAS G12D only in the OFF state or only in the ON state.

In June 2025, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic ductal carcinoma (mPDAC), metastatic colorectal cancer (mCRC), advanced non-small cell lung cancer (NSCLC), and other solid tumors. Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed, open-label clinical trials: TARGET-D 201 (NCT07644559) in second-line advanced or metastatic PDAC, TARGET-D 202 (NCT07659782) in second/third-line advanced or metastatic NSCLC, and TARGET-D 203 (NCT07659795) in metastatic CRC. In June 2026, the company announced the first patient was dosed in the TARGET-D 201 trial.

In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic pancreatic ductal carcinoma who have received at least one prior line of standard systemic therapy. In June 2026, the FDA also granted FTD to VS-7375 for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially.

In December 2023, Verastem selected VS-7375 as its lead program from its collaboration with GenFleet Therapeutics, which aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. In January 2025, Verastem exercised its license for VS-7375. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375 as GFH375 in China.

(Press release, Verastem, JUL 22, 2026, View Source [SID1234669370])

On July 22, 2026 Tikva Allocell reported the successful closing of an $8 million Series A financing round, led by Kantharos Capital. The capital will accelerate the development of Tikva’s novel off-the-shelf, engineered allogeneic T-cell platform designed to tackle persistent challenges in solid tumor oncology.

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The funding will primarily support the completion of IND-enabling studies and regulatory filings for Tikva’s lead candidate, TAVST01, as the company prepares to enter clinical development in both Singapore and the United States.

Overcoming the Solid Tumor Barrier
While allogeneic (donor-derived) cell therapies hold immense promise for scalable cancer treatment, host immune rejection often clears (allorejection) these cells before they can deliver sustained therapeutic benefit.

Tikva’s platform solves this challenge through a multi-pronged approach:

EBV-Specific T-Cell Backbone: Built on donor Epstein-Barr virus (EBV)-specific T cells—cells the human immune system naturally recognizes and tolerates long-term—minimizing Graft-versus-Host Disease (GvHD) risk without requiring heavy gene editing.
SerpinB9(CAS) "Armor": Engineered with an optimized variant of SerpinB9 (a inhibitor of granzyme B and caspases). This enhancement shields the cells from host cell rejection and activation-induced cell death (AICD), enabling long-term persistence in the tumor microenvironment.

Our lead candidate, TAVST01, targets B7-H3—an antigen widely overexpressed across multiple high-need solid tumors, including including lung, breast, prostate, pancreatic, and pediatric cancers.

(Press release, Tikva Allocell, JUL 22, 2026, View Source [SID1234669369])

On July 22, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on overcoming cancer drug resistance, reported a strategic collaboration with Bayer to evaluate Kairos Pharma’s lead antibody ENV-105 (carotuximab), a first-in-class CD105/BMP signaling inhibitor, in combination with Bayer’s XOFIGO (radium-223 dichloride) in metastatic castration-resistant prostate cancer (mCRPC) involving bone.

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Kairos Pharma’s current programs with ENV-105 include a Phase 1 trial in EGFR-driven non-small cell lung cancer and a Phase 2 trial for castrate resistant prostate cancer. Last year, Kairos announced positive interim efficacy data from the Phase 2 trial showcasing median progression-free survival was more than 13 months, a significant improvement from standard of care. These data were presented at the 2025 ESMO (Free ESMO Whitepaper) Congress in Berlin. XOFIGO is the first and only FDA-approved alpha-emitting radiopharmaceutical for mCRPC with symptomatic bone metastases and is currently advancing through additional combination studies, including the Phase III PEACE-3 trial, which demonstrated a 24% reduction in mortality risk when combined with enzalutamide (HR 0.76; p=0.009).

"Drug resistance remains one of the greatest challenges in advanced prostate cancer, and XOFIGO, like many standard-of-care therapies, can lose efficacy over time," said John Yu, M.D., Chief Executive Officer of Kairos Pharma. "ENV-105 has already demonstrated the ability to re-sensitize tumors to existing treatments with a strong safety profile, and this collaboration with Bayer represents a major milestone in our mission to deliver more durable and more effective treatment regimens for patients with metastatic prostate cancer."

Previous published work has demonstrated the efficacy of ENV-105 in radiation sensitization in prostate cancer preclinical models. CD105 is upregulated in response to standard androgen receptor inhibition and in responses to ionizing radiation, driving pro-survival BMP-SMAD signaling pathways underlying therapy resistance. Targeting CD105 with ENV-105 re-sensitizes resistant tumors and may extend the duration and depth of response to XOFIGO’s targeted alpha therapy.

Neil Bhowmick, Ph.D., Chief Scientific Officer and Principal Investigator stated, "CD105’s role as a central resistance mechanism validated now across multiple drug classes makes this collaboration scientifically compelling and clinically timely, given XOFIGO’s recent Phase III momentum."

(Press release, Kairos Pharma, JUL 22, 2026, View Source [SID1234669367])

On July 22, 2026 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, reported the regulatory approval to expand FLAMINGO-01 into the United Kingdom.

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The Company’s application to expand FLAMINGO-01 into the UK has been formally approved by UK regulators, thus adding potentially 5-10 geographically distributed UK sites to the approximately 170-180 approved sites in the US and Europe.

The Company is collaborating with The Royal Marsden, a leading cancer research institute. Working with The Royal Marsden, we have been in discussions with many academic sites located in the following cities: London (multiple sites), Cambridge, Edinburgh, Oxford, Manchester, Southhampton, Cardiff, and potentially other cities. With regulatory approval, these start-up discussions will now move forward. The principal investigator at Royal Marsden, who will be serving as the UK national principal investigator, also plans to join the Steering Committee.

CEO Snehal Patel commented, "We are very excited to be adding these UK sites from prominent research institutions. The initial introduction was driven by patient interest in the UK. Our hard work with The Royal Marsden in submitting our regulatory application has now paid off with our regulatory approval. The UK population of 70 million is one of the largest populations in Europe and we look forward to offering participation in FLAMINGO-01 to these patients."

The Royal Marsden opened in 1851 as the world’s first hospital dedicated to cancer diagnosis, treatment, research and education. Today it operates as a specialist cancer centre. Together with its principal academic partner, The Institute of Cancer Research, London, The Royal Marsden is designated as the UK’s only National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) dedicated solely to cancer. The Royal Marsden and The Institute of Cancer Research (ICR) are recognised as one of the top four comprehensive cancer centres in the world for the impact of their research, influencing cancer treatment and care for all cancer patients. As a centre of excellence, they pioneer the very latest in cancer treatments and technologies, as well as leading the way in innovative cancer diagnosis and education.

Based on 2019 and 2021-2022 data from Cancer Research UK, there are approximately 59,400 new breast cancer cases in the UK every year. Breast cancer is the most common cancer in females, which is 30% of all new female cancer cases.

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 profile of 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 (Free AACR Whitepaper) Meeting 2026 delayed-type-hypersensitivity (DTH) poster and the ASCO (Free ASCO Whitepaper) 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: [email protected]

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.

(Press release, Greenwich LifeSciences, JUL 22, 2026, View Source [SID1234669366])