---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-006664"
form_type: "8-K"
ticker: "GLSI"
cik: "0001799788"
company_name: "Greenwich LifeSciences, Inc."
filed_at: "2024-02-14T23:59:59+00:00"
generated_at: "2026-06-06T02:32:44.541471+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Greenwich LifeSciences expands Phase III Flamingo-01 arm to 250 patients; European sites pending

## Summary
- DSMB recommended continue as is; no serious adverse events related to GLSI-100 reported to date.
- Non-HLA-A*02 open-label arm expanded from 100 to 250 patients per Steering Committee guidance.
- European regulatory approval expected 2024; contracts for 105-120 sites in Spain, France, Germany, Italy, Poland.
- First 3 commercial lots of GP2 completed in 2023; enough for ~200,000 doses; commercial vial filling planned 2024.
- Phase II data review found potential recurrence in treated arm (Q4 2023); company states no material effect on study power.

## SEC filing metadata
- accession: 0001493152-24-006664
- form_type: 8-K
- ticker: GLSI
- cik: 0001799788
- company_name: Greenwich LifeSciences, Inc.
- filed_at: 2024-02-14T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1799788/000149315224006664/0001493152-24-006664-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1799788/000149315224006664/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-006664
- JSON: https://secwatch.observer/filing/0001493152-24-006664.json
- Plain text: https://secwatch.observer/filing/0001493152-24-006664.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.