Greenwich LifeSciences, Inc. - GLSI STOCK NEWS

Greenwich LifeSciences (NASDAQ: GLSI) provided a year-end update on its clinical-stage immunotherapy, GLSI-100, aimed at preventing breast cancer recurrences. The company is expanding the Flamingo-01 Phase III trial, currently involving 20 US clinical sites recruiting patients, with plans to add 60-75 sites in Europe. CEO Snehal Patel expressed optimism from meetings at the 2022 SABCS and announced commercial manufacturing efforts for GP2, aiming to produce approximately 200,000 doses. A new patent application was filed regarding GP2’s use in immune response assays, enhancing the company's intellectual property portfolio.

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) has announced an extension to the lock-up period for shares owned by directors, officers, and pre-IPO investors until December 31, 2023, approximately 39 months post-IPO. The company is focused on developing GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences in patients post-surgery. The ongoing Phase III clinical trial, Flamingo-01, will evaluate the safety and efficacy of GLSI-100 in HER2/neu positive breast cancer patients. The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival.

Greenwich LifeSciences (GLSI) announced the launch of its Phase III clinical trial, Flamingo-01, aimed at evaluating the immunotherapy GLSI-100 for HER2/neu positive breast cancer patients. The trial, which commenced screening and enrollment at multiple sites, follows promising Phase IIb results showing 100% disease-free survival. The Company is entering pre-commercialization activities, including preparing for a BLA submission and initiating large-scale manufacturing. Key milestones include future presentations of trial data and ongoing licensing discussions.

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) has initiated the Flamingo-01 Phase III clinical trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences post-surgery. Clinical site activation is in progress across multiple hospitals, alongside site initiation training for clinical staff. The trial intends to enroll approximately 500 patients, with initial Phase III data expected by year-end. The company maintains a strong cash position, allowing for strategic financial maneuvers. CEO Snehal Patel indicated that results from the trial could validate prior Phase IIb findings, which showed no recurrences in treated patients over 5 years.

Greenwich LifeSciences (NASDAQ: GLSI) announced its well-capitalized status with a cash balance of $19.7 million as of March 31, 2022. The company aims to transition to an investment banking syndicate through a recent ATM sale agreement to use opportunistically. The commencement of the Phase III clinical trial, Flamingo-01, is expected to gradually increase the burn rate. Updates on the trial and ongoing studies will be provided soon, with a focus on immunotherapy GLSI-100 for breast cancer prevention.

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) announced that the FDA has lifted the clinical hold on its Flamingo-01 Phase III clinical trial, allowing the company to proceed. The hold was previously imposed due to manufacturing and pharmacy process issues related to the candidate GP2. Following successful discussions and testing with the FDA, these concerns have been addressed. The trial is now moving forward with site initiation visits underway, and further updates on the trial's progress will be provided.

Greenwich LifeSciences, Inc. (NASDAQ: GLSI) has announced the suspension of its share repurchase program. Previously, the Company repurchased around 520,000 shares for approximately $7.5 million. Following these transactions, GLSI has about 12.8 million shares of common stock outstanding. This decision comes amid considerations that may impact future financial strategies.

Greenwich LifeSciences (GLSI) has announced the resumption of its Stock Repurchase Program, authorized by its board. The program allows the company to buy back shares in the open market or through private transactions, depending on market conditions. With approximately $4.5 million remaining under this program, Greenwich had 12,951,453 shares outstanding as of March 31, 2022. The company is also advancing its clinical trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences.

Greenwich LifeSciences (NASDAQ: GLSI) is progressing towards initiating the FLAMINGO-01 Phase III trial focused on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. FDA reviews are underway related to manufacturing plans that led to a clinical hold. Site contracts with major U.S. oncology networks are finalized, enabling patient enrollment. Upcoming presentations at the ASCO Annual Meeting aim to enhance outreach. The trial, designed to evaluate 500 patients, aims for significant efficacy in preventing breast cancer recurrence.