Mr. Patel appeared as a featured guest for the second time in a live interview on the TD Ameritrade Network The Watch List with host Nicole Petallides. A webcast of the interview is available here.

In the interview, Patel explained how the new results from the Phase IIb clinical trial could lead to a new treatment that complements GP2 peptide therapy and allows doctors to detect recurrences of metastatic breast cancer earlier. Data from the recently published Phase IIb clinical trial show that 22.8% of 145 patients exhibited an immune response to GP2 prior to any treatment with GP2. Generally, no response to GP2 is expected before treatment with GP2. However, an immune response was observed in these patients before any treatment with GP2, suggesting that their cancer was already recurrent. Data suggests that patients with an immune response to GP2 before treatment relapsed twice as quickly and about 7 to 11 months earlier than those without an immune response before treatment. The number of recurrences was low in the phase IIb clinical trial, so these observations will be further confirmed in the larger phase III trial, and data will be available as early as 2022.

Dr. Patel continued to discuss how, in the Phase III clinical trial, T cells will be fully characterized and identified at the DNA level to better understand the initial immune response to GP2. GP2 immunotherapy trains T cells to attack metastatic breast cancer. By identifying the specific GP2 T cells that attack cancer, the most effective T cells could be developed as drug candidates and delivered directly to patients as a treatment using CAR-T cell technology. Thus, the Company could use this new patentable T cell technology for both diagnosis and treatment, extending the Company’s pipeline beyond GP2 and further benefiting patients.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the GP2 + GM-CSF combination will be called GLSI-100. The phase III trial consists of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A * 02 patients and 1 open arm of up to 100 patients for all other types of HLA. An interim analysis was designed to detect a risk ratio of 0.3 in the IDFS, where 28 events will be required. An interim analysis of superiority and futility will be conducted when at least half of these events, 14, have occurred. This sample size provides 80% power if the annual event rate in subjects treated with placebo is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the trial link and identifier will be published shortly. For future updates on FLAMINGO-01, please visit the Company’s Clinical Trials tab at https://greenwichlifesciences.com/clinical-trials/.

About Breast Cancer and HER2 / new Positivity

One in eight American women will develop invasive breast cancer in her lifetime, with an estimated 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2 / new (human epidermal growth factor receptor 2) is a cell surface receptor protein that is expressed in a variety of common cancers, including 75% of breast cancers at low (1+), intermediate (2+) and high (3+ or over-expressing).

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrence in patients with previous surgery. GP2 is a 9 amino acid transmembrane peptide of HER2 / new protein. In a randomized, single-blind, placebo-controlled, multicenter (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrence was observed in the HER2 / new Adjuvant 3+ setting after 5 years of median follow-up, if the patient received the 6 primary intradermal injections during the first 6 months ( p = 0.0338 ). Of the 138 patients who have been treated with GLSI-100 to date in 4 clinical trials, the treatment has been well tolerated and no serious adverse events have been observed related to immunotherapy. Greenwich LifeSciences plans to begin a Phase III clinical trial using a treatment regimen similar to that of 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 the immune response of GP2 immunotherapy

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

Disclaimer regarding forward-looking statements

The statements contained in this press release contain “forward-looking statements” which 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”, “might”, “estimate”, “expect”, “have l ‘intention’, ‘search,’ ‘may’, ‘might’, ” ” ” ” ” ” ” ” ‘terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc. current expectations and are subject to inherent uncertainties, risks and difficult-to-predict assumptions, including statements regarding the intended use of the net proceeds from the public offering; therefore, actual results may differ materially from those expressed or implied by such forward-looking statements. In addition, certain forward-looking statements are based on assumptions about future events which may not prove These and other risks and uncertainties are more fully described in the section entitled “Risk Factors” of the relative final prospectus. to the public offering filed with the SEC. The forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. assumes no obligation to update such information, except as required by applicable law.

Email: [email protected] Investor contact and public relations for Greenwich LifeSciences

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

KEYWORD: TEXAS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH CLINICAL TRIALS ONCOLOGY

SOURCE: Greenwich LifeSciences, Inc.

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PUB: 12/15/2021 6:00 a.m. / DISC: 12/15/2021 6:01 a.m.