false
0001799788
0001799788
2024-02-14
2024-02-14
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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) February 14, 2024
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.
On
February 14, 2024, Greenwich LifeSciences, Inc. (the “Company”) issued a press release providing an update on its Phase III
Clinical Trial, Flamingo-01. A copy of the press release is attached hereto as Exhibit 99.1
and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
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:
February 14, 2024 |
By: |
/s/
Snehal Patel |
|
|
Snehal
Patel |
|
|
Chief
Executive Officer |
Exhibit
99.1
Greenwich
LifeSciences Provides Update on Phase III Clinical Trial, Flamingo-01
STAFFORD,
Texas, February 14, 2024 — (Globe Newswire) — 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 provided the following update on the Phase
III clinical trial, Flamingo-01.
Data
Safety Monitoring Board (DSMB)
The
Flamingo-01 DSMB met twice in 2023 and recommended to continue the study as is without modification. No serious adverse events related
to GLSI-100 have been reported to date.
US
Clinical Sites Participating in Flamingo-01
Approximately
30 clinical sites with 87 locations at multiple hospitals and the largest oncology network in the US are currently recruiting patients
and are listed below. While the first site was activated in August 2022, the first patient was screened and treated in December 2022.
Other sites enrolled their first patients in 2023 with additional sites being activated throughout the year. The Company anticipates
adding up to an additional 10 sites in 2024, bringing the total sites in the US to approximately 35-40 sites.
European
Clinical Sites and Networks Participating in Flamingo-01
Pending
European regulatory approval, which is expected in 2024, contracts are in place to add up to an additional 105-120 sites in Europe including
Spain (38), France (21), Germany (32), Italy (9), Poland (6), and potentially additional countries in Europe, bringing the total number
of potential sites in Flamingo-01 to approximately 140-160 sites between the US and Europe. With a peak enrollment estimate of approximately
2 - 4 patients per site per year, 150 active sites in Flamingo-01 could see peak enrollment of up to 300-600 patients per year. The logistics
to supply GP2 and Leukine labeled in each language, to collect patient samples, and to supply all other clinical supplies have been contracted
in Europe and are in the final stages of being implemented.
European
academic networks in each country are planning to participate in Flamingo-01 and are listed below. These networks represent the largest
oncology focused hospitals and centers in Europe, where breast cancer leaders work in a collaborative manner to help advance promising
therapies and they hold annual scientific meetings where Flamingo-01 has been introduced and where the company may present in the future.
GEICAM
is the leading group in breast cancer research in Spain and currently consists of more than 900 experts, who work in more than 200 centers
throughout Spain. Since its establishment in 1995, GEICAM has carried out more than one hundred studies in which more than 66,000 women
and men have participated.
UCGB
or Unicancer is the federation of French comprehensive cancer centers, a major player in cancer research and a network of 20 private,
non-profit healthcare centers specialized in oncology, brought together in a health cooperation group.
GBG
Forschungs GmbH is one of the world’s leading breast cancer research institutes that works together with the academic study group
German Breast Group (GBG). With more than 67,000 study participants and 3,500 new patients per year, GBG is the largest breast cancer
study group in Germany, consisting of more than 1,000 doctors in over 800 centers.
GIM
(Gruppo Italiano Mammella) is a cooperative Italian network for breast cancer research and therapy. GIM brings together over 150 participating
centers and around 500 investigators.
SABCS
Update & Flamingo-01 Steering Committee
At
the 2023 San Antonio Breast Cancer Symposium (SABCS) and 2023 ASCO Annual Meeting, the Company met with the Flamingo-01 Steering Committee
and clinicians from the US and various countries in Europe who are participating or planning to participate in Flamingo-01.
The
Steering Committee is comprised of the following members:
| ● | Dr.
Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive
Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer
Center |
| ● | Dr.
Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University,
Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research
group UCBG (Unicancer) |
| ● | Dr.
William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at
Northwestern University, Chief of Hematology and Oncology in the Department of Medicine,
and Betsy Bramsen Professor of Breast Oncology |
| ● | Dr.
Sara A. Hurvitz – Professor of Medicine, Head of Division of Hematology/Oncology at
University of Washington, Senior Vice President of the Clinical Research Division at the
Fred Hutchinson Cancer Center |
| ● | Dr.
Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant
Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH &
Chair of the German Breast Group (GBG) |
| ● | Dr.
Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón
General University Hospital, Complutense University, Madrid, Chairman of GEICAM |
| ● | Dr.
Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University
Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas |
| ● | Dr.
Hope S. Rugo – Professor of Medicine and Winterhof Family Professor of Breast Oncology
and Director, Breast Oncology and Clinical Trials Education, University of California, San
Francisco, Helen Diller Family Comprehensive Cancer Center |
| ● | Dr.
Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending
Physician, Medical Oncology, Massachusetts General Hospital |
The
Steering Committee discussed unpublished data, including new research the Company conducted in 2023, that suggests that GP2 may bind
to various HLA types and not just HLA-A*02, in addition to discussing the prior data that supports the third arm of the Phase III trial,
where 100 non-HLA-A*02 patients are currently planned to be enrolled. The Steering Committee agreed to expand this third arm to 250 patients.
Given the encouraging data and the Steering Committee’s guidance, the Company will amend the Flamingo-01 protocol to allow up to
250 patients to enroll in the open-label arm of the study.
Dr.
Rimawi, Chair of the Steering Committee, commented, “Among my peers, the level of interest in the Flamingo-01 trial is very high.
The new sites in Europe will make significant contributions to the trial in terms of patient enrollment as well as overall conduct of
the trial. The expansion of the unblinded non-HLA-A*02 arm is also significant as it reflects the interest among patients and investigators
in exploring the activity of GLSI-100 in these patients, which may expand the patient population who could benefit from this exciting
vaccine.”
Dr.
Jaye Thompson, VP Clinical and Regulatory Affairs, commented, “We
welcome the new US and European members to the Steering Committee and are honored to be receiving their continued guidance in the development
of GP2 and oversight of Flamingo-01. The Company spent considerable time in Europe in 2023 planning and organizing in each country. We
have trained the country specific research networks in each country with the assistance of the key opinion leaders of these countries
and worked closely as a group as we applied through a central European regulatory process to allow Flamingo-01 to expand into Europe.
We expect to be able to expand the third arm to 250 patients in a cost-effective manner as 85-100% of the global sites plan to enroll
into the third arm. We have also seen an increase in interest from third parties in India and China, countries with the largest prevalence
of breast cancer, who are interested in further developing GP2 for their patient populations.”
Planned
Interim Analysis
In
the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up
to 250 patients of other HLA types will be treated with GLSI-100 in the third arm.
For
the HLA-A*02 randomized arms, the trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free
survival, 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.
CEO
Snehal Patel commented, “With
the addition of the European sites and approximately 150 total sites, peak enrollment rates could be reached by the end of 2024 allowing
for a refinement in the interim analysis. Currently, enrollment will likely end before the interim analysis is triggered by 14 events.
However, the interim analysis could be modified such that an additional sizing interim analysis is conducted before enrollment ends to
reaffirm the size of the 2 randomized arms. While the hazard ratio of 0.3 assumes that the recurrence rate of the treated arm will be
30% of the recurrence rate in the placebo arm and thus a 70% reduction in recurrence rate, and while the Phase II trial showed even greater
reduction in recurrence rate, we are likely to see recurrences in the treated arm of the Phase III trial and have designed the trial
accordingly. Using the early Phase III trial data to reaffirm the size of the arms of the Phase III trial may be the best information
we could use to reduce risk and improve the chances of success of Flamingo-01.”
Mr.
Patel further added, “While
we may have high expectations for the interim analysis midway through the trial, Roche’s
successful Herceptin and Kadcyla products reduced recurrences by only 50%, while still requiring that all HER2 positive patients be treated.
Thus, we believe a similar clinical outcome for Flamingo-01 could occur and could generate similar returns to stakeholders as did Roche’s
franchise drugs, which at their peak significantly exceeded $5 billion in revenue per year.”
Preparation
for Filing of BLA in the US
In
addition to the submission of the Phase III clinical data, submitting commercial manufacturing data and study reports on the prior clinical
trials will be critical to the filing of a BLA for GLSI-100 and for regulatory filings in other countries.
Commercial
Manufacturing: The first 3 commercial lots of GP2 active ingredient were completed and released
in 2023, representing an important step towards commercialization. The 3 lots in total could be used to prepare approximately 200,000
doses of GP2. In 2024, the first of 3 commercial lots filling GP2 into vials for commercial sale or for clinical use is planned. Data
on these commercial lots will be submitted to the FDA in the US and other regulatory agencies in Europe or elsewhere when a marketing
application is filed seeking approval to sell GP2 in these respective markets.
Phase
II Clinical Trial Study Report: The Company is preparing a comprehensive study report of the Phase II trial for the FDA prior to
the filing of a BLA. This report will include the patients with breast cancer recurrences, the last known date of patients who did not
recur (censoring data), the adverse events, immune responses, and other final study report analyses. This report will serve to complement
the Phase III data and to provide a drug product dossier that can also be submitted to regulatory agencies in other countries for marketing
approval. The use of GM-CSF as an adjuvant in GLSI-100 may also be included in the dossier as GM-CSF is only commercially available in
the US at this time.
Mr.
Patel commented, “We
have experienced significant interest from investors, strategics, analysts, and regulators in the 5 year follow-up data we published
and the 3 and 4 year follow-up data independently published by the clinical investigators. The differences between these publications
can be best explained by the increased maturity of the data as each year progressed. In all 3 publications, no recurrences or a 100%
reduction in recurrence rate, were reported in the sub-population that the Flamingo-01 design has been based on and any differences between
the number of patients in the treated or placebo groups has been shown to be immaterial.”
The
Company did not have responsibility for the conduct of the trial or for the data from the Phase II trial. After the trial had already
started, the Company received the rights to the Phase II trial data pursuant to a license agreement with the Henry Jackson Foundation
(HJF) that entitled the Company to all of the GP2 data from the Phase II trial and all prior trials, but did not provide the Company
with the ability to participate in the Phase II trial as a regulatory clinical sponsor. The lead clinicians and HJF were responsible
for project and site management, medical monitoring, data monitoring of case report forms (CRFs), correspondence with the FDA, and creation,
data entry and management of the database. The Company was provided study updates but was not provided an opportunity to participate
in any of the above activities or to review the publications of the 3 and 4 year follow-up data by the lead clinicians. Thus, the comprehensive
study report will rely on cooperation from HJF and the clinical sites who are responsible for providing the final data accurately to
the Company.
The
Company is currently comparing the final CRFs and database provided by HJF and has noted the following inconsistencies as the comprehensive
study report is being prepared. The lead
clinicians reported in an annual report to the FDA and in their publication of 4 year follow-up data a 6th recurrence in the HER2 positive
control arm of the study. The Company conservatively chose not to report this 6th recurrence since it was not reported in the data provided
by HJF, even though adding this recurrence to the control arm would significantly lower the p-value and improve the evidence of efficacy
of GLSI-100. As a result of detailed due diligence, the Company became aware in Q4 of 2023 of a potential recurrence in the HER2 positive
treated arm. This patient was not reported as a recurrence in the database, on a CRF that should be used for a recurrence, in reports
from the lead clinicians to the FDA, or in the 3 or 4 year follow-up data published by the lead clinicians. Some CRFs report a recurrence,
but the critical CRF that confirms a recurrence was not completed or entered into the database provided by HJF. The Company has since
initiated an effort to confirm with HJF and the clinicians who treated this patient the status of this patient, and if the final CRFs
and database should be modified. It appears that this patient, who had completed treatment with GLSI-100, experienced a local recurrence
that responded well to additional treatment and survived without additional evidence of disease or distant metastasis for the duration
of study follow-up. Any discrepancies noted to date in the review of the censoring date recorded in the database do not materially change
the study results and the median duration of follow-up remains 5 years.
Mr.
Patel added, “While a recurrence
in the control arm would decrease the p-value and still result in a 100% reduction in the recurrence rate, a recurrence in the treated
arm would increase the p-value and would result in an 80% reduction in the recurrence rate. In either case, we believe that the reduction
in recurrence rate is clinically meaningful and substantial compared to the approximately 20-50% reduction in recurrences of all other
approved breast cancer drugs for this patient population. These findings have not materially affected the power of the Phase III study
as the assumptions for that design were selected conservatively.”
Additional
Clinical Trials Under Consideration
The
following trials are under consideration, pending additional funding and resources:
| ● | Phase
IIb trial to add an additional 5 years of follow-up to the prior Phase IIb trial: If
possible, extending the follow-up period of the prior Phase IIb trial to up to 10 years may
increase the understanding of the length of protection offered by GP2 and the need for additional
boosters after the current booster regimen ends. This data may also shed some insight on
how to optimize vaccination, how to vaccinate the 3 million survivors in the U.S. who are
many years removed from adjuvant treatment, and how to vaccinate long term metastatic breast
cancer survivors. Such a trial extension would require a new follow-up protocol and the cooperation
of clinicians and patients who participated in the prior Phase II trial. |
| ● | Phase
II/III trial of all low risk HER2 positive patients not eligible for Flamingo-01: If
possible, the Company could leverage the current trial
infrastructure in the US and Europe to potentially treat all HER2 positive patients and not
just those who are high-risk, which is the current design of Flamingo-01. Some patients in
the prior Phase II trial were low-risk, which suggests that GP2 may also work in the low-risk
population. This trial would be large and lengthy due to fewer recurrence events, but starting
it now would be cost effective given the 150 sites which would have access to these patients.
|
Mr.
Patel further commented, “If
successful, vaccinating HER2 positive patients who are long term survivors or are at low risk for recurrence could more than double the
patient population being pursued in Flamingo-01. Low HER2 breast cancer patients and HER2 positive patients in other cancers also remain
possible patient populations to pursue in the future, especially in combination with checkpoint inhibitors and Herceptin antibody drug
conjugates.”
New
Intellectual Property
In
the first quarter of 2023, a new patent application was filed with regards to the use of GLSI-100 to reverse a suppressed immune state
and to activate an immune response against HER2 positive cancer cells if they reappear. Plans are in place to potentially file additional
patent applications with regards to GP2 manufacturing, pharmacy, or injection processes. The Company is developing an assay that may
be applicable to the manufacturing of GP2 and is exploring alternative formulations to minimize the reconstitution process in the pharmacy,
both of which may provide additional patent opportunities.
2023
Corporate Events
The
Company’s
events in 2023 are listed below and on the events calendar (view here), and for the first time included 3 invitations to present
at scientific and clinical conferences, a recognition of the promising GP2 clinical data and the potential of Flamingo-01: Think Tank
(a collaborative conference with research and clinical experts in breast cancer), Hawaii Breast (featuring the majority of US KOLs),
and the 16th International Symposium on Translational Research in Oncology (featuring European scientific and clinical academia).
| ● | Dec
15, 2023 – 2023 Annual Meeting of Stockholders |
| ● | Dec
5 - 9, 2023 – 2023 San Antonio Breast Cancer Symposium (SABCS) |
| ● | Nov
6 - 8, 2023 – BIO-Europe Fall 2023 |
| ● | Oct
20 - 22, 2023 – European Society for Medical Oncology (ESMO) Congress 2023 |
| ● | Oct
7, 2023 – 2023 Komen Houston Race for the Cure |
| ● | Sep
27 - 29, 2023 – 16th International
Symposium on Translational Research in Oncology |
| ● | Sep
11 - 13, 2023 – H.C. Wainwright 24th Annual Global Investment Conference |
| ● | Aug
16 - 19, 2023 – Hawaii Breast 2023 |
| ● | Jun
5 - 8, 2023 – BIO 2023 International Convention |
| ● | Jun
2 - 6, 2023 – 2023 American Society of Clinical Oncology (ASCO) Annual Meeting |
| ● | May
11 - 13, 2023 – European Society for Medical Oncology (ESMO) Breast Cancer 2023 |
| ● | Apr
15 - 19, 2023 – American Association for Cancer Research (AACR) Annual Meeting 2023 |
| ● | Feb
6 - 9, 2023 – 2023 BIO CEO & Investor Conference |
| ● | Jan
9 - 13, 2023 – Breast Cancer Think Tank Conference |
List
of US Clinical Sites Participating in Flamingo-01 Phase III Clinical Trial
Patients
who are interested in participating in the Flamingo-01 Phase III clinical trial can learn more about the study at www.clinicaltrials.gov/study/NCT05232916.
Each clinical trial site location is listed on the website under “Contacts
and Locations” with a new feature showing each site on a map. Patients should contact
a participating clinical trial site near them or Flamingo-01@GreenwichLifeSciences.com for screening. The current listing of US
sites from the clinicaltrials.gov website with email contact information for some sites
is shown below and will be continually updated during the trial. Additional sites are planned to be opened at large hospitals in Boston,
Philadelphia, and Baltimore/Washington DC.
Arizona
Arizona
Oncology Associates, PC - HOPE
Tucson,
Arizona, United States, 85745
Contact:
Stacey Kimbell, R.N. Stacey.Kimbell@usoncology.com
Principal
Investigator: Aisha Ahmed, MD
California
Comprehensive
Blood and Cancer Center
Bakersfield,
California, United States, 93309
Principal
Investigator: Ravindranath Patel, MD
Providence
Medical Foundation
Fullerton,
California, United States, 92835
Contact:
Rebeca Sanchez 714-446-5177 rebeca.sanchez2@providence.org
Contact:
Linda Gozar linda.gozar@stjoe.org
Principal
Investigator: Monica Lee, MD
University
of Southern California
Los
Angeles, California, United States, 90033
Contact:
Kimberly Arieli Kimberly.Arieli@med.usc.edu
Principal
Investigator: Danielle Sterrenberg, MD
University
of California, Los Angeles
Los
Angeles, California, United States, 90404
Contact:
Monica Rocha MPRocha@mednet.UCLA.edu
Principal
Investigator: Aashini Master
Stanford
Women’s Cancer Center
Palo
Alto, California, United States, 74304
Contact:
Sasha Madan madan2@stanford.edu
Principal
Investigator: Fauzia Riaz, MD
University
of California, San Francisco Helen Diller Family Cancer Center
San
Francisco, California, United States, 94158
Principal
Investigator: Hope Rugo, MD
Torrance
Memorial Physicians Network
Torrance,
California, United States, 90505
Contact:
Jessica Yoshinaga jyoshinaga@mednet.ucla.edu
Principal
Investigator: David Chan, MD
PIH
Hospital - Whittier
Whittier,
California, United States, 90602
Contact:
Kristine Bradbury Kristine.Bradbury@pihhealth.org
Principal
Investigator: Lisa Wang, MD
Colorado
Rocky
Mountain Cancer Centers
Denver,
Colorado, United States, 80220
Contact:
Jennifer Hege Jennifer.Hege@USOncology.com
Principal
Investigator: Mabel Mardones, MD
Connecticut
Yale
University
New
Haven, Connecticut, United States, 06511
Principal
Investigator: Michael DiGiovanna, MD
Florida
University
of Miami
Coral
Gables, Florida, United States, 33146
Contact:
Maria Ferrer-Guerra mtf89@med.miami.edu
Principal
Investigator: Mauricio Escobar, MD
Orlando
Health Cancer Institute
Orlando,
Florida, United States, 32806
Contact:
Melinda Porter Janice.Porter@orlandohealth.com
Principal
Investigator: Nikita Shah, MD
Moffitt
Cancer Center
Tampa,
Florida, United States, 33612
Contact:
Julian Guerrero Julian.Guerrero@Moffitt.org
Principal
Investigator: Aixa Soyano, MD
Illinois
Northwestern
University
Chicago,
Illinois, United States, 60611
Contact:
clinicaltrials@northwestern.edu
Principal
Investigator: William Gradishar, MD
Maryland
Maryland
Oncology Hematology (USOR)
Annapolis,
Maryland, United States, 21401
Contact:
Gloria Seho-Ahiable Gloria.Seho-Ahiable@USOncology.com
Principal
Investigator: Jeanine Werner, MD
Missouri
Washington
University Siteman Cancer Center
Saint
Louis, Missouri, United States, 63110
Principal
Investigator: Faisal Fa’ak, MD
Nebraska
Nebraska
Cancer Specialists (USOR)
Omaha,
Nebraska, United States, 68114
Contact:
Heather Cordes hcordes@nebraskacancer.com
Principal
Investigator: Mary Wells, MD
University
of Nebraska Medical Center
Omaha,
Nebraska, United States, 68198
Principal
Investigator: Jairam Krishnamurthy, MD
Nevada
Comprehensive
Cancer Centers of Nevada
Henderson,
Nevada, United States, 89052
Contact:
Lindsay Kondo lindsay.kondo@usoncology.com
Principal
Investigator: Stephani Christensen, MD
New
York
New
York Oncology
Clifton
Park, New York, United States, 12065
Contact:
Josephine Faruol josephine.faruol@usoncology.com
Principal
Investigator: Karen Tedesco, MD
Columbia
University
New
York, New York, United States, 10032
Contact:
cancerclinicaltrials@CUMC.Columbia.edu
Principal
Investigator: Julia McGuinness, MD
Stony
Brook University
Stony
Brook, New York, United States, 11794
Contact:
Pushpa Talanki Pushpa.talanki@stonybrookmedicine.edu
Contact:
Jules Cohen jules.cohen@stonybrookmedicine.edu
Principal
Investigator: Jules Cohen, MD
Ohio
Oncology
Hematology Care Clinical Trials
Cincinnati,
Ohio, United States, 45211
Contact:
Douglas Hart Douglas.Hart@usoncology.com
Principal
Investigator: Patrick Ward, MD
Oregon
Compass
Oncology (USOR)
Tigard,
Oregon, United States, 97223
Contact:
Jennifer Thompson Jennifer.Thompson@usoncology.com
Principal
Investigator: Jay Andersen, MD
Pennsylvania
Redeemer
Health
Meadowbrook,
Pennsylvania, United States, 19046
Contact:
Nadine Varney 215-544-5832 nvarney@holyredeemer.com
Principal
Investigator: Pallav Mehta, MD
Texas
Texas
Oncology - Austin
Austin,
Texas, United States, 78745
Contact:
Sara Manning Sara.Manning@usoncology.com
Principal
Investigator: Debra A Patt, MD
Texas
Oncology - Dallas (USOR)
Dallas,
Texas, United States, 75246
Contact:
Christine Terraciano Christine.Terraciano@usoncology.com
Principal
Investigator: Cynthia Osborne, MD
Texas
Oncology - Dallas Presbyterian Hospital
Dallas,
Texas, United States, 75231
Contact:
Nancy Jones nancy.jones@usoncology.com
Principal
Investigator: Kristi McIntyre, MD
The
University of Texas Southwestern Medical Center
Dallas,
Texas, United States, 75390
Principal
Investigator: Nisha Unni, MD
Baylor
College of Medicine
Houston,
Texas, United States, 77057
Contact:
Rebecca Hildebrandt Rebecca.Hildebrandt@BCM.edu
Principal
Investigator: Mothaffar Rimawi, MD
Texas
Oncology San Antonio (USOR)
San
Antonio, Texas, United States, 78240
Contact:
Shannon Syring Shannon.Syring@usoncology.com
Principal
Investigator: Emmalind Aponte, MD
Texas
Oncology - Gulf Coast
Sugar
Land, Texas, United States, 77479
Contact:
Melissa Howell Melissa.Howell@usoncology.com
Principal
Investigator: Jorge Darcourt, MD
Texas
Oncology - Tyler (USOR)
Tyler,
Texas, United States, 75702
Contact:
Shelly Maxfield Shelly.Maxfield@USOncology.com
Principal
Investigator: Nanna Sulai, MD
Utah
University
of Utah Huntsman Cancer Institute
Salt
Lake City, Utah, United States, 84112
Principal
Investigator: Mei Wei, MD
Virginia
Virginia
Cancer Specialists
Fairfax,
Virginia, United States, 22031
Contact:
Carrie Friedman Carrie.Friedman@USOncology.com
Principal
Investigator: Shruti Tiwari, MD
About
Flamingo-01 and GLSI-100
Flamingo-01
(NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy
of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual
disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab
based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical
sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally.
In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and
up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio
of 0.3 in invasive breast cancer-free survival, 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.
For
more information on Flamingo-01, please visit the Company’s website here and clinicaltrials.gov here.
Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts
and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation
interest can be emailed to: flamingo-01@greenwichlifesciences.com
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, a
cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low
(1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, Flamingo-01.
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.
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 entitled “Risk Factors” in
Greenwich LifeSciences’ Annual Report on Form 10-K for the year ended December 31, 2022 and
other periodic reports 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.
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)
Email:
dave@redchip.com
v3.24.0.1
Cover
|
Feb. 14, 2024 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Feb. 14, 2024
|
Entity File Number |
001-39555
|
Entity Registrant Name |
Greenwich
LifeSciences, Inc.
|
Entity Central Index Key |
0001799788
|
Entity Tax Identification Number |
20-5473709
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
3992
Bluebonnet Dr
|
Entity Address, Address Line Two |
Building 14
|
Entity Address, City or Town |
Stafford
|
Entity Address, State or Province |
TX
|
Entity Address, Postal Zip Code |
77477
|
City Area Code |
(832)
|
Local Phone Number |
819-3232
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common
stock, $0.001 par value
|
Trading Symbol |
GLSI
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
true
|
Elected Not To Use the Extended Transition Period |
false
|
X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
+ Details
Name: |
dei_AmendmentFlag |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
+ Details
Name: |
dei_DocumentPeriodEndDate |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:dateItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
+ Details
Name: |
dei_DocumentType |
Namespace Prefix: |
dei_ |
Data Type: |
dei:submissionTypeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
+ References
+ Details
Name: |
dei_EntityAddressAddressLine1 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionAddress Line 2 such as Street or Suite number
+ References
+ Details
Name: |
dei_EntityAddressAddressLine2 |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- Definition
+ References
+ Details
Name: |
dei_EntityAddressCityOrTown |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCode for the postal or zip code
+ References
+ Details
Name: |
dei_EntityAddressPostalZipCode |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the state or province.
+ References
+ Details
Name: |
dei_EntityAddressStateOrProvince |
Namespace Prefix: |
dei_ |
Data Type: |
dei:stateOrProvinceItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityCentralIndexKey |
Namespace Prefix: |
dei_ |
Data Type: |
dei:centralIndexKeyItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionIndicate if registrant meets the emerging growth company criteria.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityEmergingGrowthCompany |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
+ Details
Name: |
dei_EntityFileNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:fileNumberItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
+ References
+ Details
Name: |
dei_EntityIncorporationStateCountryCode |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarStateCountryItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityRegistrantName |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b-2
+ Details
Name: |
dei_EntityTaxIdentificationNumber |
Namespace Prefix: |
dei_ |
Data Type: |
dei:employerIdItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionLocal phone number for entity.
+ References
+ Details
Name: |
dei_LocalPhoneNumber |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:normalizedStringItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 13e -Subsection 4c
+ Details
Name: |
dei_PreCommencementIssuerTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 14d -Subsection 2b
+ Details
Name: |
dei_PreCommencementTenderOffer |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTitle of a 12(b) registered security.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection b
+ Details
Name: |
dei_Security12bTitle |
Namespace Prefix: |
dei_ |
Data Type: |
dei:securityTitleItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionName of the Exchange on which a security is registered.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Number 240 -Section 12 -Subsection d1-1
+ Details
Name: |
dei_SecurityExchangeName |
Namespace Prefix: |
dei_ |
Data Type: |
dei:edgarExchangeCodeItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Exchange Act -Section 14a -Number 240 -Subsection 12
+ Details
Name: |
dei_SolicitingMaterial |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
+ References
+ Details
Name: |
dei_TradingSymbol |
Namespace Prefix: |
dei_ |
Data Type: |
dei:tradingSymbolItemType |
Balance Type: |
na |
Period Type: |
duration |
|
X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/presentationRef -Publisher SEC -Name Securities Act -Number 230 -Section 425
+ Details
Name: |
dei_WrittenCommunications |
Namespace Prefix: |
dei_ |
Data Type: |
xbrli:booleanItemType |
Balance Type: |
na |
Period Type: |
duration |
|
Greenwich LifeSciences (NASDAQ:GLSI)
Historical Stock Chart
From Apr 2024 to May 2024
Greenwich LifeSciences (NASDAQ:GLSI)
Historical Stock Chart
From May 2023 to May 2024