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) April 13, 2023
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 ☒
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.
Greenwich LifeSciences, Inc. (the “Company”) is confirming the following in light of the interest in both of its GP2 Phase IIb clinical trial and Phase III clinical trial, Flamingo-01:
The Food and Drug Administration (the “FDA”) reviewed the Company’s Phase IIb clinical data before the commencement of the Flamingo-01 clinical trial. The first US sites were activated in the 3rd Quarter of 2022 and the clinical trial is currently enrolling patients and has been screening and treating patients since the 4th Quarter of 2022. DTH skin tests are being conducted and blood samples are being collected to assess immune response. The Company is planning an expansion of the Flamingo-01 clinical trial into Europe.
The abstract and poster at the upcoming AACR conference, scheduled for the Phase II and Phase III Clinical Trials in Progress poster session on April 17, 2023, is focused only on the design of Flamingo-01 and is intended for discussions with clinicians.
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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: April 13, 2023 | By: | /s/ Snehal Patel |
| Snehal Patel | ||
| Chief Executive Officer | ||
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