Greenwich LifeSciences to Present at 2022 BIO CEO & Investor Conference

Rhea-AI Summary

Greenwich LifeSciences, Inc. (Nasdaq: GLSI) announced that CEO Snehal Patel will present at the 2022 BIO CEO & Investor Conference on February 14, 2022. The conference, from February 14-17, focuses on biotech networking and investment opportunities. Greenwich is developing GLSI-100, an immunotherapy to prevent breast cancer recurrences, currently in the FLAMINGO-01 Phase III clinical trial targeting HER2-positive patients. The trial aims to assess effectiveness based on interim analyses of patient outcomes.

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 Snehal Patel, CEO of Greenwich LifeSciences, will present in-person at 2:30 pm ET on February 14, 2022 at the 2022 BIO CEO & Investor Conference and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

BIO CEO & Investor Conference

The 2022 BIO CEO & Investor Conference will be held from February 14-17, 2022. For more than 20 years, the BIO CEO & Investor Conference has fueled biotech industry networking with premier investor and banking communities, focused on established and emerging publicly traded and select private biotech companies. In addition, there will be four days of in-person and virtual meetings with institutional investors, industry analysts, and senior business development executives seeking potential investments and deal partners. For more information please visit: https://www.bio.org/events/bio-ceo-investor-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. 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 any 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/20220131005952/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 the significance of the BIO CEO & Investor Conference for GLSI?

The BIO CEO & Investor Conference is vital for GLSI as it provides a platform for CEO Snehal Patel to discuss the company’s developments, especially the GLSI-100 immunotherapy.

When will Greenwich LifeSciences present at the BIO conference?

Greenwich LifeSciences will present at the BIO CEO & Investor Conference on February 14, 2022, at 2:30 pm ET.

What is GLSI-100 and its purpose?

GLSI-100 is an immunotherapy developed by Greenwich LifeSciences to prevent breast cancer recurrences in patients who have undergone surgery.

What is the FLAMINGO-01 trial about?

The FLAMINGO-01 trial is a Phase III study assessing GLSI-100’s effectiveness in preventing breast cancer recurrences among HER2-positive patients.

What are the expected outcomes from the FLAMINGO-01 trial?

The trial aims to detect a hazard ratio of 0.3 in invasive disease-free survival with interim analyses conducted at specific event thresholds.