Greenwich LifeSciences Announces Positive Immune Response Data from FLAMINGO-01 Phase III Clinical Trial
FLAMINGO-01 Immune Response Data Summary
The Company has analyzed the preliminary immune response data from FLAMINGO-01. Immune response data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types (non- HLA-A*02), show that GLSI-100 is creating an immune response over time as the frequency of patients exhibiting an injection site reaction or GP2 Delayed-Type Hypersensitivity (DTH) skin test reaction as measured by induration or erythema is increasing with increased vaccinations.
The number of patients experiencing an immune response increased over time from baseline through the 4th to 6th month vaccinations in both HLA-A*02 and non-HLA-A*02 arms.
In addition, a baseline immune response to GP2 is being observed before any treatment with GP2 in both HLA-A*02 and non-HLA-A*02 arms. This result suggests that GP2 is a natural antigen, that may have been part of an immune response in the patient during prior trastuzumab or other treatments.
These two general immune response findings, immune response at baseline and increasing immune response over time, were also observed in the Phase IIb clinical trial for HLA-A*02 only patients. These results confirm that the HLA prevalence, safety, and immune response in FLAMINGO-01 patients is trending as expected in both HLA arms.
The Company recently filed patent claims for non-HLA-A*02 patients which may be solely owned by the Company separate from any prior license. These claims are also supported by binding prediction algorithms and in vitro binding experiments conducted by the Company. This represents an invention that was originated by the Company which could double the number of patients eligible for GP2 treatment to approximately 88,000 new patients per year in the US and Europe. The market potential using the drug prices per year of Kadcyla or Enhertu could be in the range of $8-10 billion per year.
As mentioned in a prior press release, the non-HLA-A02 types that are most commonly being enrolled in FLAMINGO-01 include HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label immune response data is based on the patients enrolled to date in FLAMINGO-01 and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results and the results at the end of the study may differ.
CEO Snehal Patel commented, "We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a second pivotal and blinded Phase III trial. If successful, the Company could pursue approval for both HLA-A*02 and non-HLA-A*02 patients in similar time frames using independent or combined analysis of the two patient groups with the potential to double the market for GP2 to up to $10 billion in revenue per year."
Mr. Patel added, "The Company may choose to expand its immune response analysis of GP2 specific T cells by sequencing the DNA of the T cells at baseline and after treatment with GP2. The T cell sequences can be compared to the immune response increases over time. Expansion into GP2 specific CAR-T cells could potentially become another platform technology to complement GP2 peptide treatment for non-responding higher risk patients. Blood samples have been collected at multiple timepoints for future T cell and immune response analysis."
Previously Published Phase IIb Immune Response Data
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up compared to 20-50% reduction in recurrence rate by other approved products
Peak immune response at 6 months
No reported serious adverse events attributable to treatment
Well-tolerated safety profile
Full immunization was received in the Primary Immunization Series (PIS), which included the first 6 GLSI-100 injections over the first 6 months. The PIS elicited a potent immune response as measured by local skin tests and immunological assays. Further, booster injections given every 6 months prolonged the immune response, thereby providing longer-term protection. In the Phase IIb and three Phase I clinical trials, where 146 patients were treated, the GP2 immunotherapy was well tolerated, and there were no reported serious adverse events related to GLSI-100.
The Phase IIb immune response data in HLA-A*02 only patients was published at AACR in 2021 with the following findings:
GP2 immunotherapy generated GP2-specific immune responses leading to promising clinical benefit, thus supporting GP2's mechanism of action.
Immune responses to GP2 were measured over time using a CD8 T cell dimer binding assay (Dimer Binding Assay) and GP2 DTH skin tests. GP2 immunity peaked at 6 months in HER2 3+ patients after they completed their first 6 immunizations, as measured by the Dimer Binding Assay. The data also shows that for the 2.5 years that the immune response was measured, the immunity was sustained and remained above baseline, resulting in a reduction in metastatic breast cancer recurrences.
Broad based immune response suggests that GP2 immunotherapy and Herceptin based products may also have the potential to treat low HER2 and other HER2 1-3+ expressing cancers in combination with trastuzumab or trastuzumab antibody drug conjugates.
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 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 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/ 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 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 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 and follow the Company's Twitter at 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, 2023 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 ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.comSign in to access your portfolio
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Plumbing businesses often experience fluctuations tied to weather, regional housing cycles, and municipal projects. During high-demand months, cash flow is strong. In slower periods, however, the same companies may face difficulty covering payroll and overhead. No credit check business loans provide a buffer that allows them to bridge those gaps without sacrificing staff or service quality. There is also growing interest from contractors who want to expand into specialized niches. For example, plumbing businesses branching into green technology installation, water efficiency systems, or large-scale commercial contracts require upfront capital to invest in equipment and staff training. Traditional lenders may hesitate to approve loans for such ventures, viewing them as untested. With ROK's approach, these contractors gain access to the capital needed to explore new revenue streams at the pace the market demands. Some contractors are motivated by speed alone. They may not face major credit challenges but cannot afford the long approval processes banks impose. In competitive bidding environments, access to fast funding often determines who secures a project. These businesses gravitate toward ROK Financial's programs because approvals and disbursements align with real-world timelines. It is important to note that interest is not confined to plumbing contractors exclusively. Reports on best contractor loans for companies facing credit hurdles and HVAC business loans expanding nationwide show how the same financing model is resonating across multiple trades. The plumbing sector, as one of the most essential services, benefits from the credibility of a program already tested across similar industries. Ultimately, the contractors gravitating toward these programs share a common theme: they want financing solutions that reflect their actual work capacity, not outdated credit systems. Whether they are seasoned professionals with credit setbacks, ambitious newcomers without lending history, or growth-minded entrepreneurs breaking into new markets, the demand for accessible financing unites them. Contractors evaluating these opportunities can review ROK Financial's plumbing loan programs here while comparing them to broader national coverage such as best no credit check financing programs expanding in 2025. Market Category Reflections – Why the Plumbing Contractor Loan Niche Is Expanding in 2025 The rise of plumbing contractor business loans reflects a broader transformation taking place in the small business lending landscape. In 2025, the market for alternative financing has moved from the margins into the mainstream. What once seemed like a niche solution for businesses with limited options is now one of the fastest-growing categories in financial services. Plumbing contractors sit at the center of this shift, representing the intersection of high community demand and restricted access to capital. Several macroeconomic forces are driving this expansion. Inflation continues to place pressure on contractors, pushing up the price of pipes, fittings, and essential equipment. At the same time, supply chain delays and rising labor costs create unpredictable expenses. Contractors need financing that adapts quickly to these realities. Traditional banks, however, remain tied to legacy approval models that move too slowly. This mismatch has created fertile ground for companies like ROK Financial to step in with responsive solutions. Technology is also reshaping expectations. Contractors today are far more comfortable with digital-first platforms than in past decades. From bidding on jobs to managing payroll, most business processes now operate online. It follows naturally that financing should as well. Platforms offering fast applications, clear terms, and rapid funding are positioned to thrive in this environment. For plumbing contractors, the ability to secure financing in days instead of weeks or months has become a deciding factor in selecting providers. Another reason this niche is expanding is the ripple effect from related industries. Reports on roofing contractor loans accelerating before storm season and HVAC financing options broadening in 2025 illustrate how demand spans multiple trades. As each sector embraces alternative financing, awareness grows among contractors across the board. Plumbing, as a core service in both residential and commercial projects, benefits directly from this spillover effect. Cultural factors also play a role. Younger generations of contractors are less tied to the idea of walking into a bank branch for financing. They are digital natives who expect to access funding through platforms that mirror the speed and convenience of their daily lives. This mindset aligns with the rise of no credit check programs that prioritize real-time business performance over rigid credit models. The result is a growing acceptance that alternative financing is not a last resort but a smart business decision. From a market perspective, this acceptance represents a turning point. What was once considered 'alternative' financing is becoming a standard part of contractor operations. As plumbing businesses use loans to purchase vehicles, invest in new technology, and expand service areas, the visibility of these programs grows. The more contractors see peers successfully funding growth through platforms like ROK Financial, the more the category solidifies its legitimacy. This expansion has also drawn attention from analysts tracking keyword and search data. Interest in terms like 'best plumbing contractor business loans,' 'bad credit contractor financing,' and 'no credit check business funding' continues to rise on Google Trends. Each month, more contractors search for these solutions, reflecting the ongoing growth of the niche. The surge in organic demand is reinforcing the financial viability of providers operating in this space. For plumbing professionals evaluating the market, this context is essential. By understanding that they are part of a larger national trend, contractors can move forward with greater confidence in pursuing no credit check loans. The shift toward alternative financing is not temporary — it represents a structural change in how small businesses fund operations. Contractors interested in learning more can review the official ROK Financial plumbing contractor loan programs or explore national reporting on no credit check financing demand rising across 2025. Public Debate – Supporters, Skeptics, and the Signals Behind the Buzz As demand for plumbing contractor business loans accelerates in 2025, public debate surrounding these programs has intensified. Supporters highlight the opportunities unlocked by fast, flexible financing, while skeptics question sustainability and long-term costs. This back-and-forth has become a defining feature of online conversations, industry commentary, and financial analysis, reflecting how central these loans have become to small business survival and growth. Supporters of alternative financing programs emphasize empowerment. For contractors who struggled with limited options in the past, the ability to secure no credit check loans feels like a necessary evolution. Many business owners describe gaining access to working capital as the turning point that allowed them to expand service fleets, cover payroll during lean months, or accept larger commercial contracts. Their stories often frame these loans as a lifeline that levels the playing field against competitors with stronger credit backgrounds. These positive accounts are reinforced by broader media coverage. Articles on contractor loan programs for businesses with credit challenges and reports on bad credit business loans surging nationwide provide validation that these financing solutions are not isolated experiments but part of a national trend. For many plumbing contractors, seeing their industry reflected in national coverage adds legitimacy and confidence to their decision to pursue financing through providers like ROK Financial. Skeptics, on the other hand, raise important questions. Online discussions often include warnings about interest rates, repayment terms, and the possibility of contractors becoming overly reliant on loans. Some argue that while the immediate benefits are clear, the long-term costs could put pressure on businesses if not managed carefully. Others worry about whether lenders can maintain flexibility if economic conditions worsen, or if increased demand will lead to stricter requirements over time. These skeptical perspectives do not dismiss the value of financing outright but highlight the need for transparency and education. Contractors who enter agreements without fully understanding repayment structures may face challenges later. This is why providers like ROK Financial emphasize upfront clarity, flexible terms, and straightforward documentation. By addressing these concerns directly, lenders aim to differentiate themselves from less transparent competitors. A third group in the debate is more neutral, observing the trend as a natural reflection of broader market forces. Analysts point out that small business lending has historically gone through cycles of tightening and loosening credit. In their view, the rise of alternative financing is not surprising given current conditions of inflation, high demand for trade services, and risk aversion from traditional banks. These observers frame the debate less in terms of good or bad, and more as a sign of where the lending market is headed in the long term. The conversation also highlights important signals behind the buzz. Contractors' willingness to discuss their financing experiences publicly shows a shift in attitudes. Financing is no longer a private subject but part of an open dialogue about running a competitive business. The frequency of keywords like 'best plumbing contractor loans' and 'no credit check financing' in online searches is a measurable indicator that demand is both broad and growing. For contractors considering their options, the debate itself is useful. Hearing both supportive and skeptical voices helps business owners make more informed decisions. Supporters highlight the growth opportunities, skeptics emphasize the need for caution, and neutral observers provide context about the larger market. Together, these perspectives form a complete picture that reflects the complexity of small business financing in 2025. Contractors ready to evaluate their options can review the official ROK Financial plumbing loan programs here and compare their features against broader industry coverage such as best no credit check financing programs expanding this year. About ROK Financial ROK Financial has built its reputation as a leading small business financing partner by focusing on accessibility, transparency, and long-term growth support. Founded with the mission of helping entrepreneurs overcome barriers in the traditional lending system, the company has consistently expanded its offerings to meet the evolving needs of contractors, service providers, and independent business owners across the United States. At its core, ROK emphasizes an education-first approach. Instead of presenting loans as one-size-fits-all products, the platform guides business owners through different financing options, explaining repayment structures, eligibility factors, and the potential impact on day-to-day operations. This emphasis on clarity is a key reason many contractors continue returning for new rounds of funding as their businesses scale. The company has also positioned itself as a trusted partner for industries often excluded from mainstream financing. Beyond plumbing, ROK has expanded into specialized programs for HVAC, roofing, cannabis, and other sectors where traditional banks remain hesitant. Coverage such as best HVAC business loans for contractors with bad credit and cannabis financing programs launched in 2025 reflects how the same commitment to flexibility applies across multiple markets. Plumbing contractors, in particular, benefit from this experience because ROK's frameworks are tested and proven in other complex industries. Another defining value is speed. In today's economy, waiting weeks or months for financing approval can mean losing critical contracts. ROK has invested in digital systems that shorten timelines without sacrificing due diligence. For contractors, this speed translates into the ability to act decisively — purchasing materials, hiring staff, or responding to emergencies without delay. Equally important is the company's focus on building sustainable relationships. ROK does not position itself as a short-term fix but as an ongoing partner in business growth. Contractors who start with small working capital loans often return for larger financing as their companies expand. This continuity builds trust and aligns with ROK's long-term vision of supporting businesses throughout their full growth cycle. Community impact is another central theme. By improving access to financing, ROK strengthens the contractors who maintain essential services for local economies. When plumbers have the resources to take on projects, communities benefit from faster repairs, improved infrastructure, and greater economic stability. This ripple effect underscores why inclusive financing models matter at both the business and societal levels. Today, ROK Financial stands as a recognized leader in alternative financing. Its expansion into plumbing contractor loans reflects not only a response to rising demand but also a continuation of its mission to support entrepreneurs in industries overlooked by traditional lenders. Contractors and business owners interested in exploring options can visit the official ROK Financial plumbing loan program page for details and review broader market reporting on contractor loans designed for credit-challenged businesses. Contact Final Disclaimer This press release is for informational purposes only. The content herein does not constitute financial, legal, or medical advice. Best Plumbing Contractor Business Loans is not intended to diagnose, treat, predict, or guarantee any result or outcome. Individual experiences may vary, and outcomes are not assured. Some links in this release may be promotional in nature and may lead to third-party websites. The publisher or author may receive compensation through affiliate commissions if a purchase is made through these links. This compensation does not affect the price you pay and helps support continued research and content publication. All statements made about product features, platform strategies, or financing programs reflect publicly available information, user discussions, or historical trends, and are not endorsed or validated by regulatory bodies. Please perform your own research before making financial, technological, or purchasing decisions. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. 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