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Greenwich LifeSciences, Inc. reports developments as a clinical-stage biopharmaceutical company focused on FLAMINGO-01, a Phase III clinical trial evaluating GLSI-100 as an immunotherapy intended to prevent breast cancer recurrences. GLSI-100 combines the GP2 peptide with GM-CSF and is described by the company as a Fast Track designated program.
Recurring news includes FLAMINGO-01 clinical-site activity, oncology conference abstracts and posters, open-label immune-response and recurrence-rate data, patent-claim updates tied to GP2, at-the-market equity financing activity, and SEC reporting or Nasdaq compliance matters related to periodic filings.
Greenwich LifeSciences (NASDAQ: GLSI) has announced a partnership with GBG (German Breast Group) for its Phase III clinical trial, FLAMINGO-01. The collaboration involves approximately 38 German clinical sites, with most already approved by German authorities and initiating start-up activities in 2024.
GBG, Germany's largest breast cancer research network, includes over 1,000 doctors across 800+ centers, managing 67,000+ study participants and 3,500 new patients annually. The FLAMINGO-01 trial evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences in HER2+ high-risk patients.
The first German patient was randomized and treated in October 2024. This partnership is significant given that Germany reported 75,267 new breast cancer cases in 2022, representing 29% of all cancers in women, with 20,601 deaths that year.
Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, announced the activation of clinical sites in France for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy to prevent breast cancer recurrences. The trial will involve approximately 19 French sites within the Unicancer network, the largest academic breast cancer research network in France. These sites were approved by French authorities in Q1 2024, and 15 sites have already undergone initiation visits and training in 2024, with the remaining 4 sites scheduled for start-up activities in Q1-Q2 of 2025.
Unicancer, which is dedicated to oncology, brings together 18 Cancer Centers (CLCC) and cares for nearly 530,000 patients annually. Unicancer is a leading academic sponsor of clinical trials in oncology in Europe, with 106 active clinical trials in 2020 and nearly 7,600 patients enrolled. Dr. F.C. Bidard, who serves on the FLAMINGO-01 Steering Committee and is the national Principal Investigator for France, highlighted the promise of GLSI-100 in improving outcomes for patients at high risk of relapse.
CEO Snehal Patel commented on the strategic partnership with Unicancer, emphasizing the opportunity to offer FLAMINGO-01 to patients across France efficiently.
Greenwich LifeSciences (NASDAQ: GLSI) has announced a partnership with Gruppo Italiano Mammella (GIM), Italy's largest academic cooperative breast cancer research group, for its Phase III FLAMINGO-01 trial. Nine top GIM institutions, with over 150 participating centers and 500 investigators, will participate in testing GLSI-100, an immunotherapy to prevent breast cancer recurrences. The partnership addresses a significant medical need in Italy, where 58,160 new breast cancer cases were diagnosed in 2022, representing 30% of all female cancers. Patient enrollment has already begun at Italian sites, with Professor Grazia Arpino serving as the Italian National Principal Investigator.
Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company developing GLSI-100 immunotherapy for breast cancer recurrence prevention, has provided an update on its corporate events calendar. The company has participated in multiple scientific meetings, healthcare conferences, and investment events throughout 2024, including the GBG Annual Scientific Meeting, ASCO Annual Meeting, BIO International Convention, and various healthcare investment conferences. Upcoming events include the Jefferies London Healthcare Conference, San Antonio Breast Cancer Symposium, Annual Meeting of Stockholders, and conferences extending into early 2025.
Greenwich LifeSciences (Nasdaq: GLSI) has provided an update on the expansion of its Phase III clinical trial, FLAMINGO-01, into Spain. The company has partnered with GEICAM, Spain's largest academic breast cancer research network, with 38 hospitals agreeing to participate. Approximately 30 out of 38 sites have conducted site initiation visits (SIVs), and 19 sites have been activated. Multiple sites have begun screening patients for HLA type and started treatment. The company has personally visited and trained staff at 26 out of 38 sites.
CEO Snehal Patel noted that the progress in Spain from May through July has approximately doubled the number of sites opened compared to the US. The company plans to expand the clinical trial to up to 150 sites across the US, Spain, Italy, France, Germany, and Poland.
Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, announced it will rejoin the Russell 2000 and Russell 3000 Indexes. This reconstitution will take effect on July 1, 2024. GLSI is focused on its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy for preventing breast cancer recurrences. CEO Snehal Patel noted that the inclusion in the Russell 2000 Index is anticipated to increase institutional ownership, reflecting the company's progress in expanding FLAMINGO-01 into Europe and up to 150 clinical sites globally.
Greenwich LifeSciences (Nasdaq: GLSI) announced a private placement agreement with CEO Snehal Patel. The agreement involves the sale of 174,825 shares at $14.30 per share, totaling approximately $2.5 million. The closing is anticipated around June 18, 2024, subject to customary conditions. The proceeds will be used for clinical development and working capital. No investment banking fees are involved, and Patel has agreed to a one-year lock-up period for the acquired shares. The transaction was conducted under Section 4(a)(2) of the Securities Act of 1933 and Regulation D, meaning the shares are not registered and can only be resold under certain conditions.
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