Greenwich LifeSciences Announces Plan to Build Out Internal Clinical Operations Team
Rhea-AI Summary
Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, announced plans to build its internal clinical trial management team for the Phase III FLAMINGO-01 trial of GLSI-100, an immunotherapy for breast cancer recurrence prevention.
The company aims to reduce dependency on Clinical Research Organizations (CROs) by hiring dedicated internal staff, which is expected to lower costs and increase efficiency in managing clinical trial operations. This strategic shift will enable Greenwich to handle multiple trials simultaneously, including potential expansion of HLA-A*02 patient trials and development of other in-licensed drug candidates.
Positive
- None.
Negative
- Current dependence on more expensive CRO staffing
- Transition period and recruitment challenges in building internal team
Insights
Greenwich's shift to internal clinical operations may reduce costs and expand capabilities, a strategic operational improvement with moderate financial benefits.
Greenwich LifeSciences' decision to transition from external CROs to an internal clinical operations team represents a notable operational pivot for managing their Phase III FLAMINGO-01 trial. This strategy targets two critical metrics: cost reduction and operational efficiency. By bringing clinical trial management in-house, the company is addressing the typically high expenses associated with outsourcing to CROs, which can consume
The move has multiple strategic advantages beyond simple cost savings. First, it gives Greenwich greater control over trial quality and data integrity at a critical phase in their development pipeline. Second, it positions them to potentially run parallel trials simultaneously – whether expanding the current FLAMINGO-01 study or developing new indications for GLSI-100. This capability would typically require significant additional CRO expenditures.
Most importantly, the reduced burn rate provides increased financial flexibility, extending their cash runway without additional financing. For a clinical-stage biotech without revenue, optimizing capital efficiency is paramount. While this operational change doesn't directly impact the scientific prospects of their immunotherapy candidate, it does strengthen their organizational infrastructure and potentially allows for pipeline expansion beyond their current breast cancer recurrence prevention focus.
STAFFORD, Texas, Aug. 19, 2025 (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 its plan to build out its internal clinical trial management and operations team.
The Company has begun to hire its own staff to manage and operate FLAMINGO-01, while reducing its dependence on more expensive staffing from Clinical Research Organizations (CROs). The strategy to bring in key clinical functions inside the Company is expected to reduce costs over the remaining duration of the clinical trial and to increase efficiency and quality as the clinical trial continues to increase the number of enrolling sites and the number of approved participating countries.
VP Jaye Thompson commented, "Although our experience with an external CRO has been successful, the ability to reduce our costs and improve our efficiency by bringing in dedicated staff and contractors is quite appealing. Greenwich will continue to utilize select vendors to optimize our efficiency. I am thrilled with the quality of the staff that we have been able to identify and secure to help us efficiently manage the FLAMINGO-01 study."
By selecting high caliber personnel, the Company is seeking to develop the capability to conduct multiple trials simultaneously, whether it is an increase in the number of HLA-A*02 patients, the creation of pivotal treated and placebo arms for those patients who are not HLA-A*02, the pursuit of other populations and trials for GLSI-100, or the potential to develop other in-licensed drug candidates. As this buildout continues, and as the burn rate is simultaneously reduced, the Company believes it will have more options to respond to the needs of FLAMINGO-01 or to add additional pipeline indications or product lines.
CEO Snehal Patel commented, "We believe our new strategy of retaining our own clinical staff will reduce our baseline burn rate, while improving the quality of the data collected and the management and monitoring of each site in FLAMINGO-01. This internal staff is also helping us to manage our European clinical operations. In addition, if we add another GLSI-100 indication or in-license a new drug candidate, our internal clinical team built to manage a Phase III trial can more cost effectively assimilate additional studies."
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 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 and European clinical sites from university-based hospitals and academic and cooperative networks with plans 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
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 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in
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 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in
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 the most recent Form 10-K for the year ended December 31, 2024, 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
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