STAFFORD, Texas — September 30, 2025 — Leads & Copy — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) has announced the expansion of its Phase III clinical trial, FLAMINGO-01, to Portugal. The trial evaluates GLSI-100, an immunotherapy to prevent breast cancer recurrences.
European regulators have formally approved the company’s application, adding Portugal to the list of approved countries in FLAMINGO-01, which includes Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US. In 2022, 9,065 new cases of breast cancer were diagnosed in Portugal, representing about 30% of all cancers in women. Breast cancer is the leading cause of cancer deaths in women in Portugal, with 2,211 deaths in 2022.
Luís António Marques da Costa, MD, PhD, will serve as the national principal investigator in Portugal for FLAMINGO-01. Dr. Costa is an Associate Professor of Medicine, Oncology & Oncobiology, FML-UL, Lisbon, Portugal, and Head of the Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine. He has also served as Director of the Oncology Department at Hospital de Santa Maria in Lisbon since 2005.
CEO Snehal Patel expressed enthusiasm for collaborating with Dr. Costa and his colleagues, noting that they recently visited Lisbon to begin start-up activities and meet investigators to develop a strategy for Portugal. The company is activating sites in Lisbon and reviewing additional sites in central and northern Portugal.
FLAMINGO-01 (NCT05232916) is designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients with residual disease or high-risk pathologic complete response at surgery who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment. The trial is led by Baylor College of Medicine and includes US and European clinical sites.
For more information on FLAMINGO-01, visit the company’s website and clinicaltrials.gov. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 protein is expressed in a variety of common cancers, including in 75% of breast cancers.
Greenwich LifeSciences is focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01.
Contact:
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
Investor & Public Relations Contact:
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com
Source: Greenwich LifeSciences, Inc.
