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Greenwich LifeSciences, Inc. (NASDAQ: GLSI) is a clinical-stage biopharmaceutical company dedicated to the development of groundbreaking immunotherapies aimed at preventing breast cancer recurrences. The company's flagship product, GP2, is an immunotherapy designed to stimulate the body's immune system to target and eliminate HER2/neu-expressing cancer cells, particularly in patients who have already undergone surgery for breast cancer.
GP2 leverages the HER2/neu transmembrane peptide to elicit a targeted immune response, providing a promising approach to cancer treatment. Another significant component of their pipeline is the GM-CSF Immunoadjuvant, which has shown potential in enhancing monocyte and neutrophil cytotoxicity against melanoma tumor cells, as well as boosting activity-dependent cellular cytotoxicity against targets coated with anti-ganglioside antibodies.
The company’s ongoing clinical trials are a testament to its commitment to innovation and excellence in cancer treatment. These trials are being conducted in collaboration with a steering committee comprising esteemed members from various medical institutions, ensuring rigorous oversight and adherence to the highest standards of clinical research.
Greenwich LifeSciences places a strong emphasis on advancing cancer immunotherapy to selectively stimulate an individual's immune system to attack cancer cells, thereby inhibiting the spread of the disease. Their work not only focuses on breast cancer but extends to other cancer types, showcasing a broad potential for impact in oncology.
With a robust pipeline, strategic partnerships, and a clear focus on unmet medical needs, Greenwich LifeSciences is poised to be a leader in the biopharmaceutical industry. Investors and stakeholders can stay updated on the latest developments and company performance through regular news updates and reports.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) has announced the closing of its underwritten public offering, yielding gross proceeds of $26.4 million. The funds will be allocated towards manufacturing and clinical trial completions for the GP2 Phase III trial, Biologics Licensing Application submission to the FDA, and development of additional products, including a coronavirus vaccine. An additional 99,000 shares may be purchased by underwriters to increase total proceeds to approximately $30.4 million.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) announced an upsized public offering, expected to raise approximately $26.4 million. The offering includes 660,000 shares priced at $40.00 per share, with a potential increase to $30.4 million if underwriters exercise their option for an additional 99,000 shares. Proceeds will fund clinical trials, completion of manufacturing, and support for a coronavirus vaccine program. The offering is set to close around December 22, 2020.
Greenwich LifeSciences (Nasdaq: GLSI) has announced an option agreement with Westport Bio to in-license a pre-clinical coronavirus vaccine program currently in animal testing. The agreement involves up to $250,000 in research sponsorship, plus additional fees. Westport Bio's vaccine candidates aim to enhance existing DNA/RNA vaccines. CEO Snehal Patel highlighted their aim to achieve greater protection against COVID-19, leveraging previous success with a pneumonic plague vaccine that provided 100% protection. The company remains focused on its GP2 breast cancer immunotherapy while exploring new candidates.
Greenwich LifeSciences announced the publication of a second poster for its GP2 Phase III clinical trial targeting breast cancer recurrence at the San Antonio Breast Cancer Symposium. The trial seeks to replicate previous results showing no recurrences in HER2/neu 3+ patients after treatment with GP2 + GM-CSF. The Phase III trial will include interim analysis for FDA marketing approval and involve 11 injections over three years. CEO Snehal Patel expressed confidence in the collaboration with Baylor College of Medicine to achieve these goals.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) presented a poster on the final efficacy analysis of its GP2 Phase IIb clinical trial at the San Antonio Breast Cancer Symposium. The trial demonstrated a 0% recurrence rate in HER2/neu 3+ patients after 5 years, validating GP2's potential as a treatment. CEO Snehal Patel indicated plans for a Phase III trial, addressing a significant unmet need in breast cancer treatment, with a potential market exceeding $5 billion. The study included 168 patients and indicated that GP2 could also be effective for HER2/neu 1-2+ populations.
Greenwich LifeSciences (Nasdaq: GLSI) has secured a contract for the final formulation and filling of its GP2 immunotherapy, aimed at preventing breast cancer recurrences. The contract will enable the storage and distribution of GP2 to clinical sites, with activities starting in 2021. The company has also leased a facility in Stafford, Texas, to support its manufacturing and research initiatives. CEO Snehal Patel expressed optimism about these developments as crucial steps towards commencing the Phase III clinical trial following promising Phase IIb results, showing no recurrences after a median follow-up of five years.
Greenwich LifeSciences (Nasdaq: GLSI) announced it will present at the Annual LD Micro Main Event virtually on December 14-15, 2020. CEO Snehal Patel will present at 1:20 pm EST on December 15, focusing on GP2, an immunotherapy aimed at preventing breast cancer recurrences post-surgery. Recently published GP2 data and plans for a Phase III clinical trial will be highlighted. For more details, visit the investor section of the Company's website.
Greenwich LifeSciences (Nasdaq: GLSI) announced a second abstract publication at the San Antonio Breast Cancer Symposium (SABCS) regarding the Phase III clinical trial for GP2, an immunotherapy aimed at preventing breast cancer recurrence. The trial seeks FDA conditional marketing approval following an interim analysis. Phase IIb results showed a 0% recurrence rate in HER2/neu 3+ patients post-surgery. The trial will involve 11 injections over three years and targets a potential $5 billion market. CEO Patel emphasized the collaboration with Baylor College of Medicine and the significance of the Phase IIb findings.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) announced the publication of an abstract at the San Antonio Breast Cancer Symposium, highlighting positive results from its Phase IIb clinical trial for GP2 immunotherapy. This therapy demonstrated a 0% recurrence rate in HER2/neu 3+ patients over five years, surpassing the 89.4% rate of placebo patients. A pivotal Phase III trial will follow. With a potential market for GP2 estimated at $5 billion, the therapy aims to address a significant gap for patients unresponsive to current treatments.
Greenwich LifeSciences, Inc. (Nasdaq: GLSI) has been selected to present at the virtual Texas Life Science Forum from November 10-12, 2020. CEO Snehal Patel will present on November 10, from 12:00-12:50 pm EST, discussing the GP2 immunotherapy program aimed at preventing breast cancer recurrences. The event also includes one-on-one meetings and a showcase for investors, emphasizing the company's Phase III clinical trial plans. The Texas Life Science Forum, hosted by Rice Alliance and BioHouston, features over 35 life science companies.
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