Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy
Rhea-AI Summary
Greenwich LifeSciences (Nasdaq: GLSI) updated investors on cash burn and financing for its Phase III FLAMINGO-01 trial of GLSI-100. The company said ATM sales in 2025 exceeded its 2025 cash burn of approximately $9.5M, leaving ~$6M at 12/31/2025. Through the first three weeks of January 2026 the ATM raised ~$7M, bringing cash to ~$12.5M as of 1/23/2026. Figures are preliminary and unaudited. Management said 2026–2027 burn rates are expected to rise and ongoing ATM use may reduce need for a large near-term financing, but no assurance exists.
Positive
- ATM proceeds raised ~ $7M in early January 2026
- Cash balance increased to approximately $12.5M as of 1/23/2026
- 2025 ATM proceeds exceeded the 2025 cash burn of $9.5M
- Lean structure and cost savings reduced near-term cash needs
Negative
- Cash figures are preliminary and unaudited
- Projected burn rates expected to increase in 2026 and 2027
- Continued ATM use may be dilutive to shareholders
- No assurance a large near-term financing can be avoided
News Market Reaction
On the day this news was published, GLSI gained 9.62%, reflecting a notable positive market reaction. Argus tracked a peak move of +17.5% during that session. Argus tracked a trough of -2.6% from its starting point during tracking. Our momentum scanner triggered 45 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $41M to the company's valuation, bringing the market cap to $472M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
GLSI rose 20.22% while peers showed mixed moves: CHRS +12.87%, MCRB +4.2%, THTX and ACOG modestly positive, CLYM -4.02%. The pattern points to stock-specific strength rather than a broad sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 22 | FDA manufacturing approval | Positive | +5.7% | FDA cleared use of first commercial GP2 vials in FLAMINGO‑01. |
| Dec 29 | Insider lock-up extension | Positive | +19.8% | Extended director and officer lock-up through September 30, 2026. |
| Dec 22 | Trial and strategy update | Positive | +2.7% | DSMB supported continuation; broad site enrollment and ATM funding update. |
| Dec 15 | Preliminary efficacy data | Positive | -3.9% | Open-label arm showed ~80% recurrence-rate reduction in 250 patients. |
| Dec 08 | Enrollment completion | Positive | +7.5% | Completed enrollment of 250-patient non-HLA-A*02 open-label arm. |
Positive trial and corporate news have often been followed by positive price reactions, with occasional divergences even on strong clinical data.
Over recent months, GLSI has reported several FLAMINGO‑01 milestones, including completion of enrollment in the 250‑patient open‑label arm, an approximately 80% recurrence‑rate reduction signal, and FDA approval to use commercially manufactured GP2 vials at 40 US sites. Corporate actions such as extending insider lock‑ups to September 30, 2026 and detailing cash burn and ATM usage have coincided with multiple double‑digit percentage moves. Today’s cash‑burn and financing update continues this pattern of pairing trial progress with capital planning disclosures.
Market Pulse Summary
The stock moved +9.6% in the session following this news. A strong positive reaction aligns with GLSI’s pattern of responding to financing clarity and trial progress. The company reported that ATM proceeds exceeded its $9.5 million 2025 burn rate and lifted cash to about $12.5 million. With shares up 20.22% and already trading above the $11.62 200-day MA, investors have previously seen sharp swings; reliance on equity funding and past volatility could still introduce reversal risk.
Key Terms
atm financing vehicle financial
fast track regulatory
immunotherapy medical
debt/royalty financing financial
AI-generated analysis. Not financial advice.
STAFFORD, Texas, Jan. 27, 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 Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on its cash burn rate and financing strategy.
The Company's ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for 2025 exceeded the Company's 2025 cash burn rate of approximately
CEO Snehal Patel commented, "Our financing strategy in January 2026 has been quite impressive so far without daily or constant use of the ATM. The current cash balance of
Mr. Patel further added, "While our cash burn rates in 2026 and 2027 are projected to increase, the expected ongoing use of the ATM to sustain or grow the current cash balance may reduce the likelihood of the Company doing a large near term financing in 2026 or 2027, though there can be no assurance of this. Since the follow-on offering in 2020, we primarily utilized the ATM with initially Jefferies and more recently H.C. Wainwright to fund the Company. Continued use of the ATM may provide a bridge to non-dilutive funding, such as strategic/licensing partnerships or debt/royalty financing vehicles, that would further fund FLAMINGO-01 and potential commercial launch activities."
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
How much cash did GLSI report as of January 23, 2026?
What was Greenwich LifeSciences' 2025 cash burn rate (GLSI)?
How much did GLSI raise through its ATM in early January 2026?
Are GLSI's reported cash figures final and audited?
Will GLSI need a large financing in 2026 or 2027 (GLSI)?
