Greenwich LifeSciences, Inc 8-K, filed Dec 15, 2020
Greenwich LifeSciences, Inc. (GLSI)
About this 8-K
Greenwich LifeSciences, Inc filed this 8-K on December 15, 2020.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) December 15, 2020
Greenwich LifeSciences, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39555 | 20-5473709 | ||
| (State
or other jurisdiction of incorporation) |
(Commission File Number) |
(I.
R. S. Employer Identification No.) |
3992 Bluebonnet Dr, Building 14
Stafford, TX 77477
(Address of principal executive offices, including ZIP code)
(832) 819-3232
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common stock, $0.001 par value | GLSI | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 8.01 Other Events.
On December 15, 2020, Greenwich LifeSciences, Inc. (the “Company”) announced that it has entered into an option agreement with Westport Bio, exercisable at the sole discretion of the Company, to in-license a pre-clinical coronavirus vaccine program that is currently at the stage of pre-clinical animal testing. A copy of the press release is attached hereto as Exhibit 99.1and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release dated December 15, 2020 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Greenwich LifeSciences, Inc. | ||
| Date: December 15, 2020 | By: | /s/ Snehal Patel |
Snehal Patel Chief Executive Officer | ||
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Exhibit 99.1
| December 15, 2020 |  |
Greenwich LifeSciences Announces Option Agreement for Pre-clinical Coronavirus Vaccine Candidates
STAFFORD, Texas—(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 announced that it has entered into an option agreement with Westport Bio, exercisable at the sole discretion of the Company, to in-license a pre-clinical coronavirus vaccine program that is currently at the stage of pre-clinical animal testing. In exchange for the option, the Company has agreed to sponsor research in an aggregate amount of up to $250,000 plus additional license and assignment fees. Westport Bio’s coronavirus vaccine program includes up to 7 vaccine candidates which are designed to complement or improve upon the DNA/RNA based coronavirus vaccines that are in advanced Phase III clinical trials or that have recently been approved by the FDA for emergency use.
Westport Bio’s previous collaboration with an academic team led to a pre-clinically developed vaccine that showed 100% protection against a lethal challenge dose of pneumonic plague in non-human primate and rodent animal models. The collaboration has been expanded to include a coronavirus vaccine program using similar technology. The coronavirus vaccine technology makes use of multiple antigens that would complement strategies that rely solely on the spike protein as the principal antigen. The spike protein of SARS-CoV-2 plays a key role in the receptor recognition and cell membrane fusion process, but there are also other antigens that may be potential targets. In combination, these antigens may offer greater protection and longer duration of protection.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “While we are focused on the upcoming GP2 Phase III breast cancer clinical trial, and are also exploring how to expand the use of GP2 in additional indications through supplemental clinical trials, we have decided to explore the addition of new immunotherapy product candidates to our pipeline at both the pre-clinical and clinical stages of development. The objective of the coronavirus vaccine program is to leverage the development team’s experience in achieving 100% protection against lethal levels of pneumonic plague infection to increase the percent protection and duration of protection of coronavirus vaccines under development. It is not clear how long one will be protected by the current Covid-19 vaccines and none that have been developed to date offer 100% protection. We are hopeful that our approach, which showed 100% protection against pneumonic plague, may lead to greater and longer lasting protection compared to existing Covid-19 vaccines under development.”
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About Westport Bio
Westport Bio is a Texas LLC focused on multi-antigen vaccine technology. The founder of Westport Bio is Snehal Patel, CEO of Greenwich LifeSciences.
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: www.greenwichlifesciences.com
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. 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 Securities and Exchange Commission. 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: [Link to Original Source]
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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