Greenwich LifeSciences Announces FDA Approves Use of Commercially Manufactured GP2 in FLAMINGO-01
Rhea-AI Summary
Greenwich LifeSciences (Nasdaq: GLSI) said the FDA approved use of the first commercially manufactured lot of GP2 vials in the Phase III FLAMINGO-01 trial of GLSI-100 to prevent breast cancer recurrence. The company noted three commercial active-ingredient lots made in 2023 (enough for ~200,000 doses), one finished vial lot filled in 2024, and stability programs yielding 3 years of stability data supporting vial expiration. GLSI plans to start using the new vials at 40 US sites in the coming weeks and expects to submit commercial manufacturing data to support a US BLA filing under Fast Track.
Positive
- FDA approved first commercial GP2 vial lot for use in FLAMINGO-01
- Commercial API lots manufactured in 2023 supporting ~200,000 doses
- 3 years of stability data supporting vial expiration dating
- Planned rollout to 40 US sites in the coming weeks
Negative
- GLSI-100 has not received marketing approval; approval pertains to trial material use only
- At least two more finished GP2 lots must be manufactured before BLA submission
- BLA and market exclusivity remain contingent on future regulatory review and approval
News Market Reaction
On the day this news was published, GLSI gained 5.65%, reflecting a notable positive market reaction. Argus tracked a peak move of +32.9% during that session. Argus tracked a trough of -8.4% from its starting point during tracking. Our momentum scanner triggered 30 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $20M to the company's valuation, bringing the market cap to $373M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
GLSI gained 4.74% while peers were mixed: some like ACOG and CHRS were up, others like CLYM and MCRB were down, with no peers in the momentum scanner. This points to a stock-specific reaction to the FDA GP2 manufacturing news.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 29 | Lock-up extension | Positive | +19.8% | Extended insider lock-up and leak-out structure to support FLAMINGO-01. |
| Dec 22 | Trial, strategy update | Positive | +2.7% | DSMB continuity, site expansion, and cash burn/ATM funding update. |
| Dec 15 | Preliminary efficacy data | Positive | -3.9% | Preliminary ~80% recurrence reduction in open-label FLAMINGO-01 arm. |
| Dec 08 | Enrollment milestone | Positive | +7.5% | Completion of 250-patient open-label non-HLA-A*02 arm enrollment. |
| Dec 03 | Global trial update | Positive | +5.1% | Reported >1,000 patients screened across ~140 active FLAMINGO-01 sites. |
Recent GLSI news tied to FLAMINGO-01 and corporate actions has often coincided with positive price reactions, though one efficacy-related update saw a short-term pullback.
Over the past months, Greenwich LifeSciences has focused on advancing the Phase III FLAMINGO-01 trial and strengthening alignment with shareholders. In Dec 2025, the company extended insider lock-ups to September 30, 2026 and reported screening of over 1,000 patients across 140 sites. It completed enrollment of a 250-patient open-label arm and disclosed a preliminary 80% recurrence-rate reduction. The Dec 22 update highlighted an annual cash burn of about $7 million. Today’s FDA approval to use commercially manufactured GP2 in FLAMINGO-01 builds on this clinical and operational groundwork.
Market Pulse Summary
The stock moved +5.7% in the session following this news. A strong positive reaction aligns with a backdrop where GLSI already traded above its 200-day MA and sat well above its 52-week low. The FDA’s approval to use commercially manufactured GP2 in FLAMINGO-01 and progress toward a potential BLA build on prior positive trial milestones. Investors should weigh this against past volatility around clinical updates and the need for continued execution on manufacturing, regulatory submissions, and site activation.
Key Terms
immunotherapy medical
biological license application (bla) regulatory
fast track designation regulatory
market exclusivity regulatory
biologics division regulatory
AI-generated analysis. Not financial advice.
STAFFORD, Texas, Jan. 22, 2026 (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 provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01.
FDA Reviews and Approves Use of 1st GP2 Commercial Lot in FLAMINGO-01
The first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials is now approved for use in FLAMINGO-01 in the US.
CEO Snehal Patel commented, "With our manufacturing investments in 2023 and 2024, and now the FDA's review and approval to use the first commercial lot of finished GP2 vials in FLAMINGO-01, we have taken major steps to further de-risk the filing of a BLA in the US. We plan to start using these new GP2 vials in the coming weeks at all 40 US sites. We have 3 years of stability data to support the GP2 vial expiration date which may translate to the commercial expiration date of GP2 vials."
Preparation for Filing of BLA in the US under Fast Track Designation
In addition to the submission of the Phase III clinical data, submitting commercial manufacturing data for three lots will be critical to the filing of a Biological License Application (BLA) for GLSI-100 in the US and for regulatory filings in other countries. These GP2 vials can be stored in preparation for commercial launch or used in clinical trials. At least two more lots of finished GP2 product will be manufactured so that both clinical and manufacturing data are available for review by the biologics division of the FDA prior to potentially being granted a marketing license with up to 12 years of market exclusivity based on current law.
Mr. Patel further added, "We look forward to submitting the same manufacturing data to regulatory agencies in Europe, the United Kingdom, and Canada. The objective is to manufacture GP2 and to conduct FLAMINGO-01 at the 150 leading clinical sites in the US and Europe in a manner that provides for an efficient transition to product launch and commercial sales if GLSI-100 is approved."
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
- In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately
80% reduction in recurrence rate. - This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to
80% compared to a 20-50% reduction in recurrence rate by other approved products. - The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, 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.
About GLSI-100 Phase IIb Study
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 metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.- The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated 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 are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to 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
FAQ
What did the FDA approve for Greenwich LifeSciences (GLSI) on January 22, 2026?
How many GP2 doses do the 2023 commercial API lots support for GLSI (GLSI)?
When will GLSI begin using the approved GP2 vials in FLAMINGO-01 sites?
Does FDA approval of the GP2 lot mean GLSI-100 is approved for sale?
What manufacturing data does GLSI need before filing a US BLA for GLSI-100 (GLSI)?
What stability data supports the GP2 vial dating for GLSI-100?
