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 Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported positive data from all thirty evaluable patients in the Phase 2b trial of RAD101 in participants with suspected recurrence of brain metastases after radiotherapy. RAD101 is Radiopharm’s novel imaging small molecule targeting fatty acid synthase (FASN) radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The data from these findings will be used to support the initiation of a pivotal multi-center, global Phase 3 imaging trial.

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The analysis of the imaging data for all assessed lesions showed 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101. Images confirm metabolic activity in PET compared to equivocal MRI findings.

Additionally, 14 patients with evaluable six-month follow-up and/or biopsy data show preliminary 86% sensitivity, representing a strong positive trend (a secondary objective). Sensitivity measures an imaging test’s ability to correctly identify patients with disease.

"The entirety of this dataset captures the strength and potential of RAD101 to address a difficult diagnostic challenge in neuro-oncology," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Achieving the primary endpoint provides strong validation of our approach and supports the advancement of RAD101 into an intended registrational Phase 3 program. We look forward to continuing our discussions with the U.S. FDA as we finalize the study design and work toward bringing a more precise diagnostic tool to patients and clinicians. With this positive data in hand, we have a strong foundation from which to launch our pivotal trial."

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the tumors outside of the central nervous system. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1

RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 pivotal trial in the U.S.

About the Phase 2b Clinical Trial of RAD101

The U.S. multicenter, open-label, single arm Phase 2b clinical trial is assessing the diagnostic
performance of 18F-RAD101 in 30 evaluable individuals with suspected recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 PET-positive lesions and those equivocal lesions seen in conventional imaging (MRI with gadolinium) in participants with known brain metastases and suspected relapse after stereotactic radiosurgery (SRS). Secondary endpoints are sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation-associated changes in previously SRS-treated brain metastases.

About RAD101

RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, JUL 22, 2026, View Source [SID1234669382])

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 Healx, an AI-powered, clinical-stage biotech company dedicated to rare diseases, reported that the first patient has been dosed in its Phase 1/2 dose-escalation and dose-confirmation clinical trial to evaluate the safety and efficacy of HLX-4310, an investigational oral combination of a class I selective HDAC inhibitor and an mTOR inhibitor, in adolescents and adults with relapsed, refractory sarcoma, with a focus on osteosarcoma.

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Osteosarcoma is a rare, aggressive bone cancer that most often affects children, adolescents, and young adults. Patients who develop metastatic disease face particularly poor outcomes, with a five-year survival rate of less than 30% ¹. The past 40 years have brought little improvement in survival outcomes for patients with osteosarcoma, underscoring a critical need for new approaches designed to reduce relapse risk and improve long-term outcomes.

HLX-4310 represents the first clinical proof point for Healx’s broader rare oncology strategy focused on preventing metastatic recurrence, which is responsible for the vast majority of cancer-related deaths. Healx is leveraging its AI-driven discovery capabilities together with rapid iterative laboratory testing and translational validation to advance this initial therapeutic combination and generate new drug combinations designed to explore a new approach to preventing metastatic recurrence in rare oncology settings.

The trial is being advanced in collaboration with the National Pediatric Cancer Foundation’s (NPCF) flagship research program, the Sunshine Project.

Addressing an Unmet Need in Rare Oncology

"Metastatic osteosarcoma is so difficult to treat because patients can undergo intensive therapy, reach remission, and still relapse within months or within several years," said David Warshawsky, Ph.D., Global Head of Metastatic Prevention at Healx. "We believe that HLX-4310 provides a novel and differentiated approach focused on the unique biology hypothesized to drive cancer recurrence, and we are delighted to see it advance into trials."

"I’m excited to see this study begin dosing patients and to evaluate a strategy that is explicitly focused on preventing metastatic recurrence," said Amy Armstrong, M.D., Principal Investigator for the Phase 1/2 HLX-4310 trial. "This trial will evaluate the safety and tolerability of HLX-4310 and assess efficacy, including its potential to reduce cancer recurrence risk."

Partnership with NPCF’s Sunshine Project

"We are proud to support the advancement of HLX-4310 through the Sunshine Project," said David Frazer, President of the National Pediatric Cancer Foundation. "Our consortium brings together leading pediatric cancer centers to accelerate promising science into clinical studies. This trial reflects the shared commitment of the Sunshine Project and Healx to drive progress for children and young adults facing high-risk cancers like osteosarcoma."

About HLX-4310
HLX-4310 is a combination approach built around the concept of preventing metastatic recurrence rather than focusing only on overt tumors. The scientific hypothesis behind this novel strategy is based on targeting biological programs that enable micro-metastatic tumors to survive and persist at distant sites and later re-emerge as deadly metastatic disease.

HLX-4310 combines two agents with complementary activity profiles:

An investigational class I selective histone deacetylase (HDAC) inhibitor being evaluated for its epigenetic modulation of gene expression programs involved in tumor cell survival and in tumor-immune interactions; and
An mTOR inhibitor, which targets a central pathway involved in cell growth, metabolism, and stress responses.

(Press release, Healx, JUL 22, 2026, View Source [SID1234669383])

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])