On July 28, 2022 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, reported the following (Press release, Greenwich LifeSciences, JUL 28, 2022, View Source [SID1234617075]):
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We believe that the Company is well capitalized with cash balance reported on the Company’s Form 10-Q for the period ending March 31, 2022 of $19.7 million
Current burn rate has been low due to virtual corporate structure and outsourcing strategy
Commencement of Phase III clinical trial, Flamingo-01, is expected to increase burn rate gradually over time as more sites are activated, patient treatment begins, and commercial manufacturing commences
Recent "at the market" (ATM) sale agreement (see description below) entered into on July 12, 2022 with one of the leading biotech investment banks is a flexible financing vehicle designed to be used over time at share prices and quantities of shares at our sole discretion
We intend to use the ATM facility opportunistically in the future and do not presently intend to use the full amount of the ATM facility
We believe that strategic use of the ATM facility could begin our transition to an investment banking syndicate and to fundamental biotech institutional investors to complement the current retail investor base
An update on the Flamingo-01 trial is expected to be provided shortly
An update on the transition from the published Phase IIb data to future publications of open label Phase III data is expected to be provided shortly
About At the Market Sales Agreement
As disclosed in the Prospectus Supplement dated July 12, 2022, an ATM offering may be made from time to time through the investment bank by selling Company stock at the best available market price over time without a price discount and without warrants or additional dilutive financial structure. The number of shares that are sold will fluctuate based on the market price and demand for the Company’s common stock, and any additional conditions set by the Company. It is not possible at this stage to predict the number of shares that will be sold or the gross proceeds to be raised in connection with those sales. There can be no assurance that the Company will sell any shares under or fully utilize this source of financing.
More specifically, each time the Company wishes to issue and sell shares of the Company’s common stock under the sales agreement, the Company will notify the investment bank of the number of shares to be issued, the dates on which such sales are anticipated to be made, any limitation on the number of shares to be sold in any one day and any minimum price below which sales may not be made. The investment bank will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such shares up to the amount specified on such terms on the open market or in block trades.
The Company currently intends to use the net proceeds from this offering for general corporate purposes, which may include, but are not limited to, funding the clinical development and manufacturing and other expenses for GP2, research and development, general and administrative expenses, license or technology acquisitions, and working capital and capital expenditures. The Company may also use a portion of the remaining net proceeds, if any, to acquire or invest in complementary businesses, products and technologies, although there are no current commitments or agreements with respect to any acquisitions as of the date hereof.
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 will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. 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 100 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. The trial is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source
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.