Greenwich LifeSciences Extends Lock-up of Directors and Officers to June 30, 2025
Greenwich LifeSciences, Inc. extends lock-up period for shares owned by directors, officers, and pre-IPO investors until June 30, 2025, restricting sale of common stock. The move aims to maintain stability and confidence in the company during the Phase III clinical trial of GLSI-100, an immunotherapy for breast cancer recurrences.
The extension of the lock-up period for Greenwich LifeSciences' insiders is a strategic decision that may signal confidence in the company's future prospects. Lock-up periods are standard practice following an IPO, preventing the market from being flooded with shares and potentially driving down the stock price. Extending the lock-up indicates that insiders believe the stock's value may appreciate and are willing to wait for potentially higher returns. Investors often view such extensions as a positive sign, as it suggests that those with intimate knowledge of the company foresee a favorable outcome from the ongoing Phase III clinical trial, FLAMINGO-01.
However, this also means that the liquidity of the stock may remain low, which could lead to higher volatility in the stock price. Investors should consider how this reduced liquidity might affect their ability to trade the stock. Additionally, if the trial results do not meet expectations, the extended lock-up could backfire, leading to a sharp decline in stock value when the lock-up finally expires.
The focus of Greenwich LifeSciences on its Phase III clinical trial, FLAMINGO-01, is critical as it evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. The success of this trial could have significant implications for the company's valuation and its potential market share in the oncology sector. Immunotherapy represents a growing field in cancer treatment, offering the promise of more targeted and less invasive options compared to traditional therapies.
Should GLSI-100 prove effective, it could lead to a paradigm shift in breast cancer treatment protocols and offer substantial revenue streams for Greenwich LifeSciences. It is important for stakeholders to monitor the progress of this trial closely, as positive data could lead to FDA approval and commercialization, while any setbacks could pose risks to the company's financial health and stock performance.
Greenwich LifeSciences' decision to extend the lock-up period can also be interpreted within the broader context of investor sentiment and market dynamics. Extended lock-ups are not common and this move could differentiate the company from its peers. The biopharmaceutical sector is highly competitive, with investors closely monitoring indicators of confidence and potential for long-term growth.
Market research indicates that companies with unique and promising therapies in late-stage clinical trials can attract significant investor interest. The extension of the lock-up period may thus be a calculated move to align the potential release of positive trial results with an increased ability for insiders to capitalize on the company's growth. It is essential for investors to consider how this strategic move aligns with broader market trends and the competitive landscape of the biopharmaceutical industry.
03/13/2024 - 06:00 AM
STAFFORD, Texas, March 13, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company's directors, officers, and existing pre-IPO investors to June 30, 2025 which is approximately 57 months from date of the Company's IPO. During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.
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 here 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 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 info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciences dave@redchip.com
What is the ticker symbol for Greenwich LifeSciences, Inc.?
The ticker symbol for Greenwich LifeSciences, Inc. is GLSI.
What is the focus of Greenwich LifeSciences, Inc.'s Phase III clinical trial FLAMINGO-01?
The focus of the Phase III clinical trial FLAMINGO-01 by Greenwich LifeSciences, Inc. is on evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
Why did Greenwich LifeSciences, Inc. extend the lock-up period for shares owned by directors, officers, and pre-IPO investors?
Greenwich LifeSciences, Inc. extended the lock-up period to June 30, 2025, to restrict the sale of common stock by current officers, directors, and certain shareholders, aiming to maintain stability and confidence in the company during its Phase III clinical trial.
