Greenwich LifeSciences Provides Update Regarding Form 10-K Filing
Rhea-AI Summary
Greenwich LifeSciences (Nasdaq: GLSI) said its Form 10-K for fiscal 2025 remains under audit; auditors expect to complete audits before the end of May and file alongside the Form 10-Q for period ending March 31, 2026. Final adjustments focus on accounts payable tied to its global Phase III trial. The company reported an unaudited cash balance of ~$10.5 million as of March 31, 2026, subject to change after the Q1 financial review.
Positive
- Auditors expect completion of 2025 audit before end of May
- 10.5M unaudited cash balance reported as of March 31, 2026
Negative
- Form 10-K filing delayed pending final audit adjustments
- Accounts payable increased due to large global Phase III trial and elevated Europe enrollment
Key Figures
Market Reality Check
Peers on Argus
GLSI fell 5.26% while close peers showed mixed moves: THTX up 0.89%, ACOG down 2.36%, CHRS down 0.29%, CLYM down 3.52%, MCRB down 1.40%. Only one peer (ACTU, down 3.13%) appeared in the momentum scan, supporting a stock‑specific reaction.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 23 | ASCO abstract news | Positive | -5.1% | ASCO 2026 abstract acceptance with preliminary FLAMINGO‑01 immune-response data. |
| Apr 22 | Listing compliance | Negative | -5.1% | Nasdaq notice for late Form 10‑K filing and noncompliance with listing rule. |
| Apr 20 | Clinical data update | Positive | -11.6% | AACR 2026 Phase III open‑label immune-response data from FLAMINGO‑01 trial. |
| Apr 14 | Financing update | Positive | -5.3% | ATM program proceeds exceeding Q1 2026 cash burn and cash reaching about $10.5M. |
| Apr 07 | Patent expansion | Positive | +2.2% | Patent claims that could double GP2 market and extend protection to 2045. |
Recent history shows repeated negative price reactions, including sell-offs after positive clinical, patent, and financing updates, while clearly negative compliance news also drew declines.
Over the past month, GLSI has issued multiple updates tied to its Phase III FLAMINGO‑01 program and capital strategy. Clinical immune‑response data at AACR on April 20, 2026 and a patent update suggesting GP2 market potential could reach 88,000 patients/year were followed by share price declines. A Q1 2026 financing update highlighting an approximate cash balance of $10.5 million and a Nasdaq notice about late 10‑K filing also drew negative reactions. Today’s 10‑K audit delay update fits into this sequence of regulatory and trial-related disclosures.
Market Pulse Summary
This announcement updates the status of GLSI’s delayed Form 10‑K, noting auditors are still reconciling accounts payable linked to the large FLAMINGO‑01 Phase III trial and faster‑than‑expected European enrollment. The company reiterates an unaudited cash balance of about $10.5 million as of March 31, 2026, subject to Q1 review. In context of recent clinical, patent, and financing updates, investors may watch for completed audited figures, trial cost trends, and future SEC filings to clarify execution risk.
Key Terms
form 10-k regulatory
form 10-q regulatory
phase iii medical
immunotherapy medical
accounts payable financial
AI-generated analysis. Not financial advice.
STAFFORD, Texas, April 30, 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 an update on its Form 10-K filing for the fiscal year ending December 31, 2025.
The Form 10-K for the fiscal year ending December 31, 2025 is still being audited by the auditors who are both trying to reach agreement on the final figures. They have indicated that they expect to complete their audits before the end of May in conjunction with the filing of Form 10-Q for the period ending March 31, 2026.
The final adjustments are focused on accounts payable, which are related to the large global Phase III clinical trial underway and the unexpectedly large increase in screening and patient enrollment in Europe in 2024 and 2025.
As previously announced, the Company's ending cash balance as of March 31, 2026 is approximately
About FLAMINGO-01 Open Label Phase III Data
More than 1,300 patients have been screened with a current screen rate of approximately 800 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 70
-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.
- The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster can be downloaded here.
- The frequency of DTH reactions increased by approximately 4x (
290% ) in the total open-label non-HLA-A*02 population, increasing from5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001). - As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from
100% to700% . - Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
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
