Greenwich LifeSciences is developing GLSI-100, an immunotherapy meant to keep HER2-positive breast cancer from returning after treatment; it is not approved.
Greenwich's case rests on GLSI-100, the HER2-derived peptide GP2 given with GM-CSF to prevent recurrence in HER2-positive breast cancer. Its Phase III trial, Flamingo-01, enrolls patients with residual disease or a high-risk complete response after trastuzumab-based treatment and is expanding into Europe toward up to 150 sites. No results date has been given. Cash was $8.9 million at June 30, and Greenwich states substantial doubt about continuing.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: Flamingo-01 enrolls and reports
Does Greenwich report Flamingo-01 enrollment progress or an interim analysis date?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
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Greenwich runs a Phase III breast cancer trial with $8.9 million of cash
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Competitive landscape
vs. direct competitors
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.