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])

On July 22, 2026 GSK plc (LSE/NYSE: GSK) reported the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.1 The approval comes ahead of the original target action date of 18 September 2026 and follows the FDA’s Breakthrough Therapy and Orphan Drug Designations.2

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Jideytro, part of the portfolio from the recently completed acquisition of Nuvalent, Inc.3, was developed to address key efficacy and/or tolerability challenges of treating ROS1-postive NSCLC. Its next-generation design aims to combine high target-selectivity, broad coverage of ROS1 resistance mutations and blood-brain barrier penetration to address disease in the brain. Approximately 50,000 people worldwide are diagnosed each year with ROS1-positive NSCLC, often non-smokers in their 40s and 50s who could stay on treatment for several years.4,5

Tony Wood, Chief Scientific Officer, GSK, said: "The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer. Today’s approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care."

The approval of Jideytro is based on results from the global single-arm ARROS-1 phase I/II clinical trial in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor. The study demonstrated meaningful and durable responses, including in patients with brain metastases and ROS1 resistance mutations. In the overall population (n=117), the objective response rate (ORR) was 44% (95% confidence interval [CI]: 34-53%). Duration of response (DOR) rates at six and 12 months were 82% and 69%, respectively.1

The most common (≥15%) adverse reactions in the pooled safety population (n=446) included: oedema, peripheral neuropathy, constipation, fatigue and dyspnoea.1

Alexander Drilon, MD, ARROS-1 trial investigator and Chief of the Early Development Service at Memorial Sloan Kettering Cancer Center, said: "Despite advances in treatment, resistance mutations, disease progression in the brain and treatment-related adverse events continue to create challenges for patients. The responses observed in ARROS-1, including in heavily pre-treated patients, represent meaningful progress for people living with this disease."

Janet Freeman-Daily, Co-Founder and President of The ROS1ders, said: "For patients, the goal is not just more time, but quality time to live life as normally as possible while on treatment. The ROS1-positive community is deeply invested in advancing care with treatments that are effective and tolerable. Today’s approval gives patients and their doctors an important new option and represents meaningful progress for our community."

Jideytro is GSK’s first approved medicine in lung cancer. The company is advancing additional medicines from the recent Nuvalent acquisition, including neladalkib (NVL-655) for patients with ALK-altered NSCLC, which is currently under FDA review with a target decision date of 27 November 2026, and NVL-330, an investigational treatment for HER2-altered NSCLC. GSK is also advancing risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate in late-stage development with recently reported positive Phase III data6 in relapsed small-cell lung cancer from licensor Hansoh Pharma Inc.

About Jideytro
Jideytro is a kinase inhibitor that is FDA approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.

Jideytro was designed as a ROS1 selective inhibitor with broad coverage of ROS1 resistance mutations, activity against disease that has spread to the brain, durable treatment responses and a tolerable profile. Together, these features aim to help patients maintain disease control for longer while reducing the treatment challenges that can emerge over time.

The US Prescribing Information will be available here7.

About the ARROS-1 trial
ARROS-1 (NCT05118789) is a global phase I/II trial evaluating zidesamtinib in patients with advanced ROS1 positive NSCLC and other ROS1-positive solid tumours.8 The FDA approval is based on results from 117 patients with ROS1-positive NSCLC previously treated with a ROS1 inhibitor.1

Zidesamtinib continues to be studied in ARROS-1, including in first-line treatment for patients who have not previously received a ROS1 inhibitor.

About NSCLC
NSCLC is the most common form of lung cancer and is often characterised by specific genetic alterations, such as those in ALK, ROS1, or HER2. It can often metastasise (i.e. spread) to the central nervous system. It primarily affects working-age individuals. Current treatments may have efficacy and/or tolerability limitations that leave unmet need for patients.

(Press release, GlaxoSmithKline, JUL 22, 2026, View Source [SID1234669365])

On July 22, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported that it will host a webcast on Wednesday, July 22 at 8:30 a.m. ET to discuss positive updated clinical data in the TakeAim Lymphoma study, its ongoing registrational study in Primary CNS Lymphoma (PCNSL), and provide updated guidance on year-end data in the TakeAim CLL study, its ongoing Phase 2 study in Chronic Lymphocytic Leukemia (CLL).

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Participants may join the live audio webcast here or by dialing (800)-836-8184 from the United States or (646)-357-8785 from other locations or from the investor section of the Curis website. A replay of the conference call will be available at www.curis.com.

Take Aim Lymphoma

The PCNSL update includes data for 7 BTK-naïve patients and 39 BTKi-experienced patients:

(as of July 1, 2026)

(as of May 1, 2025)

Evaluable

All

Previous Data

Patients*

Patients

All Patients

BTKi-naïve

100% ORR

86% ORR

71% ORR

(5 of 5)

(6 of 7)

(5 of 7)

BTKi-experienced

33% ORR

26% ORR

27% ORR

(10 of 30)

(10 of 39)

(7 of 26)

* excludes patients who did not complete

at least 1 cycle (~1 month) of treatment

TakeAim CLL

On June 26, 2026, Curis announced that eleven clinical sites had opened for enrollment in the TakeAim CLL study and on July 6, 2026, announced that it has consented the first six patients in that study. Today, the Company announced that the number of patients consented has increased to 10, with the first five expected to be dosed by the end of July. The company is also increasing its guidance for year-end CLL data from 5 patients to 5-10 patients in December 2026.

"We are very encouraged by the updated data from the PCNSL study and by the support of clinicians and regulators for this novel treatment for patients with PCNSL. We are especially excited by the results in the BTKi-experienced patients for whom there are no approved therapies, where emavusertib has shown it can reverse disease progression in patients currently progressing on a BTK inhibitor and enable them to achieve objective responses," said James Dentzer, Chief Executive Officer of Curis. "We are also encouraged by the strong interest among clinical sites and key opinion leaders in our TakeAim CLL study that has enabled us to exceed expectations for site activation and enrollment."

About PCNSL and CLL

In PCNSL and CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim Lymphoma and TakeAim CLL Studies is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTKi blocks the BCR pathway; emavusertib blocks the TLR pathway.

BTKi is an established standard of care in Relapsed/Refractory (R/R) PCNSL. For BTKi-naïve patients, response rates can be 40%-70% and are typically partial responses. For those patients who progress on BTKi, outcomes are generally poor, with many patients proceeding directly to hospice or best supportive care. Initial clinical data have shown that adding emavusertib to a BTKi regimen, directly after a patient progresses on BTKi monotherapy, can enable patients to reverse their disease progression and achieve an objective response.

BTKi is also standard of care in CLL, where outcomes are more favorable than in PCNSL. In the registrational study for the BTKi zanubrutinib in CLL, 93% of patients were able to achieve an objective response, though only 7% achieved complete response2. More recent clinical studies have shown that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (MRD).

About the TakeAim Lymphoma Study

The TakeAim Lymphoma Study is a three-part study of emavusertib in combination with ibrutinib in patients with PCNSL (CA-4948-101, NCT03328078). Part A, the dose escalation part of the study, is complete. Part B is an ongoing single-arm study in BTKi-experienced patients. Part C is an ongoing randomized study in BTKi-naïve patients.

In 2025, Curis announced that it completed meetings with the U.S. Food and Drug Administration (FDA) and European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA) to review initial clinical data from the Phase 1/2 single-arm study in PCNSL and received guidance that this ongoing study could support an application for accelerated approval in Relapsed/Refractory (R/R) PCNSL.

About the TakeAim CLL Study

The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), with measurable residual disease (MRD+) as determined by the clonoSEQ assay and actively taking zanubrutinib for at least 12 months. Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL study by the end of July, with initial data in 5-10 patients expected in December 2026.

(Press release, Curis, JUL 22, 2026, View Source [SID1234669364])

On July 22, 2026 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), an AI company using three complementary capabilities to turn complex biomedical data into actionable insights, reported that the Company’s management team will participate in the BTIG Virtual Biotechnology Conference being held on July 28-29, 2026.

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BTIG’s virtual event will host established and emerging healthcare company management teams for one-on-one investor meetings and thematic panel discussions with industry leaders.

Management will be participating in one-on-one investor meetings on Wednesday, July 29th. Investors interested in scheduling a meeting with the BullFrog AI management team should contact their BTIG representative.

(Press release, Bullfrog AI, JUL 22, 2026, View Source [SID1234669363])

On July 22, 2026 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported comprehensive preclinical and clinical data on VB10.NEO, its individualized neoantigen therapy (INT), at the Neoantigen Summit in Amsterdam, reinforcing the program as a differentiated platform ready for strategic partnership.

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VB10.NEO is a wholly owned, DNA-based INT built on Nykode’s proprietary antigen presenting cell (APC)-targeting technology and NeoSELECTTM, an AI-driven neoantigen selection engine.

The preclinical data demonstrates the strength of Nykode’s differentiated APC-targeting, DNA-based vaccine platform, which shows a strong immunogenicity advantage over non-APC-targeted vaccines. New data showcases further enhanced immune responses with co-administration of molecular adjuvants. VB10.NEO generated robust CD4+ and CD8+ T cell responses across multiple tumor models, demonstrated stronger immune responses than peptide vaccines, durable tumor protection, and improved anti-tumor activity in combination with anti-CTLA4 or anti-PD-L1 antibody checkpoint inhibitors.

Nykode is dedicated to leverage AI and machine learning to optimize vaccine design, with new data demonstrating improved antigen secretion and selection of complex antigen designs.

"VB10.NEO is a highly differentiated individualized neoantigen therapy, combining broad, durable immune responses with scalable manufacturing. Together with our new data pointing to further optimized immune responses and further reduced manufacturing timelines, we have strengthened our confidence around VB10.NEO’s potential." said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics.

Nykode has established a clinically validated end-to-end manufacturing process for VB10.NEO, achieving 100% manufacturing success across two clinical trials. Recent improvements have meaningfully reduced manufacturing time, with a current process of under six weeks from biopsy to release. This positions Nykode as one of the fastest and most robust INT developers on the market. Future establishment of an in-house process will create a scalable, time- and cost-competitive supply chain where Nykode’s simpler plasmid DNA manufacturing process will have an inherent cost-of-goods and needle to needle time advantage over alternative technologies such as mRNA-LNP.

NeoSELECTTM, Nykode’s proprietary AI-powered neoantigen selection algorithm, demonstrated a significant correlation between highly ranked neoantigens and immunogenicity in patients. The platform was recently strengthened by a new U.S. patent extending protection through 2039.

Across two clinical trials in advanced solid tumors, VB10.NEO was safe and well tolerated, with no serious vaccine-related adverse events. Vaccine-specific immune responses were observed in 88-100% of patients, including de novo T cell responses in 85% of patients, and remained durable for more than one year after the final dose.

A new post-hoc analysis indicates that patients with a higher number of vaccine-induced immune responses showed a trend toward improved overall survival, while patients with baseline immune response to a higher number of the selected neoantigens had a significant correlation with improved overall survival, indicating that Nykode’s vaccines target clinically meaningful neoantigens. Importantly, in patients with baseline immune response to a lower number of neoantigens, a higher number of de novo vaccine-induced immune responses was significantly correlated with an overall survival benefit, indicating the potential of VB10.NEO to target relevant neoantigens and provide clinical benefit to cancer patients with an insufficient immune response to these neoantigens.

Nykode is actively exploring partnerships to advance VB10.NEO across a broad range of tumor types.

The poster will be available after the session at the Company’s Webpage:
View Source

(Press release, Nykode Therapeutics, JUL 22, 2026, View Source [SID1234669362])