Greenwich LifeSciences Provides Updates on Recent and Upcoming Developments
September 09 2021 - 6:00AM
Business Wire
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), 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, today provides
updates on recent and upcoming developments.
As of the close of markets on September 8, 2021, Greenwich
LifeSciences has the highest listed share price return of all 307
biotech IPOs tracked since February 2019 based on the Company’s
share price increase of approximately 763% from its IPO offering
price (Source: BioPharmCatalyst with data from IPOScoop).
CEO Snehal Patel commented, “We look forward to celebrating the
upcoming first year anniversary of our IPO. In addition, we are
pleased that H. C. Wainwright initiated analyst coverage of the
Company on September 1, 2021 with a price target of $78 per share,
consistent with the $75 price target from our first covering
analyst. Another important milestone is our addition to the Russell
2000, which placed more of our public float in the hands of
long-term investors.”
“The analyst coverage, participation in investor conferences,
and addition to the Russell 2000 will continue to support our
outreach to institutional investors and our transition to
investment banking partners that focus on M&A, licensing, and
long-term biotech institutional investors. We want to thank Aegis
Capital and their investors for their support during our first year
as a public company and for their continued support as we expand
our investment banking team and investor base.”
Mr. Patel added, “We are grateful to our loyal shareholders and
breast cancer patients who continue to reach out to us offering
encouragement and support. In the near future, the Company plans to
announce updates on the manufacturing of GP2 and initiation of the
upcoming Phase III clinical trial, as well as the publication of
additional data from the Phase IIb clinical trial.”
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 GP2 to date over 4 clinical
trials, GP2 treatment was well tolerated and no serious adverse
events were observed related to GP2 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210909005421/en/
Company Contact Snehal Patel Investor Relations (832)
819-3232 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 dave@redchip.com
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