Greenwich LifeSciences to Participate in Multiple Interviews and Conferences

Rhea-AI Summary

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) announces participation in interviews and conferences centered around their immunotherapy, GLSI-100, aimed at preventing breast cancer recurrences. At the 2021 San Antonio Breast Cancer Symposium, management will present two posters. A key focus is the Phase IIb trial results indicating no recurrences over 5 years for treated HER2 positive patients. Upcoming virtual conferences include H.C. Wainwright BioConnect Conference and Biotech Showcase. The FLAMINGO-01 Phase III trial aims to enroll approximately 600 patients.

STAFFORD, Texas--(BUSINESS WIRE)-- 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, today announced that the Company will participate in the following interviews and conferences.

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 https://greenwichlifesciences.com/clinical-trials/.

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.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GLSI-100 to date over 4 clinical trials, treatment was well tolerated and no serious adverse events were observed related to the immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS.

About GP2 Immunotherapy Immune Response

As previously reported, GP2 immunotherapy generated GP2-specific immune responses, leading to no metastatic breast cancer recurrence in the HER2/neu 3+ population in the Phase IIb clinical trial, thus supporting GP2’s mechanism of action. Statistically significant peak immunity was reached after 6 months of GP2 treatment, as measured in both the Dimer Binding Assay and the DTH skin test. HER2/neu 3+ population immune response was similar to the HER2/neu 1-2+ population immune response, suggesting the potential to treat the HER2/neu 1-2+ population (including triple negative breast cancer) with GP2 immunotherapy in combination with trastuzumab (Herceptin) based products and other clinically active agents. The broad based immune response suggests the potential for GP2 to treat other HER2/neu 1-3+ expressing cancers. For more information on GP2 immune response and clinical data, please visit the Company’s clinical trial tab at https://greenwichlifesciences.com/clinical-trials/.

Forward-Looking Statement Disclaimer

Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211208005036/en/

Company Contact

Snehal Patel

Investor Relations

Office: (832) 819-3232

Email: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences

Dave Gentry

RedChip Companies Inc.

Office: 1-800-RED CHIP (733 2447)

Cell: (407) 491-4498

Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

FAQ

What is Greenwich LifeSciences' upcoming clinical trial FLAMINGO-01 about?

FLAMINGO-01 is a Phase III clinical trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences in HLA-A*02 and other patients.

When will Greenwich LifeSciences present at the San Antonio Breast Cancer Symposium?

Management will present two posters at the San Antonio Breast Cancer Symposium today at 5:00 pm.

How did the Phase IIb trial results influence the development of GLSI-100?

The Phase IIb trial showed no metastatic breast cancer recurrences in HER2 positive patients over five years, supporting the advancement of GLSI-100.

When will the results of the Phase IIb trial be shared?

The results will be made available on the company's website by the morning of December 9, one year after the previous SABCS poster.

What key conferences will Greenwich LifeSciences participate in during January 2022?

Greenwich LifeSciences will participate in the H.C. Wainwright BioConnect Conference, Biotech Showcase, and BIO Partnering at JPM.