On December 8, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that the Company will participate in the following interviews and conferences (Press release, Greenwich LifeSciences, DEC 8, 2021, View Source [SID1234596596]).
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Today at 5:00 pm, the Company’s management team will be presenting two posters at the 2021 San Antonio Breast Cancer Symposium (SABCS) in person. The Company anticipates making the SABCS Phase IIb poster available on its website by the morning of December 9, exactly one year after the 2020 SABCS poster was published showing that no metastatic breast cancer recurrences were observed over 5 years of follow-up in HER2 positive patients who were fully treated. On December 9 at 2:20 pm ET, Snehal Patel, CEO of Greenwich LifeSciences, will appear as a featured guest in a live interview on TD Ameritrade Network’s The Watch List with host Nicole Petallides to discuss the poster.
A second poster at SABCS will provide further design features of the Phase III clinical trial for discussion with attending clinicians. At this hybrid conference the Company will be meeting with clinicians participating in the Phase III trial and with members of the Data Safety Monitoring Board and the Clinical Advisory/Steering Committee, both of which will provide independent oversight of the Phase III trial and will advise the Company on the conduct of the trial. The Company also hosted a dinner to bring the Phase III clinical team together.
An exclusive interview with CEO Snehal Patel was aired a second time on The RedChip Money Report on Bloomberg TV this past Saturday, December 4. In the interview Mr. Patel discusses the Phase IIb clinical trial results, the next steps for the upcoming FLAMINGO-01 Phase III clinical trial, potential Phase IIb and Phase III clinical data publications in 2022, the impact of joining the Russell 2000, and examples of recent comparable strategic transactions in breast cancer and immunotherapy. To view a replay of the interview, please click here.
During the week of January 10, 2022, Mr. Patel will participate in the following three virtual/hybrid investor conferences:
H.C. Wainwright 2022 BioConnect Conference:
The Company will be participating in the H.C. Wainwright BioConnect Conference with a virtual presentation that will be available on demand.
Biotech Showcase 2022:
The Company will be participating in the Biotech Showcase partnering event with an on-demand presentation available to conference participants and potentially an in-person presentation should conditions permit.
BIO Partnering at JPM:
The Company will be participating in the BIO partnering event at the 2022 JP Morgan Healthcare Conference.
About FLAMINGO-01 and GLSI-100
The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (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.