Recent 8-K filings for GLSI
Highest-materiality recent filing
FDA removes clinical hold on Greenwich LifeSciences' Flamingo-01 Phase III trial
- FDA formally removed the clinical hold on July 11, 2022, allowing the Flamingo-01 Phase III trial to proceed.
- Clinical hold was related to manufacturing and pharmacy process issues; company has addressed them with additional testing commitments.
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Greenwich LifeSciences raises ~$2.5M in private placement with CEO at $14.30/share
CEO Snehal Patel purchased 174,825 shares at $14.30 (June 12 closing price) for ~$2.5M gross proceeds.
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Greenwich LifeSciences expands Phase III Flamingo-01 arm to 250 patients; European sites pending
DSMB recommended continue as is; no serious adverse events related to GLSI-100 reported to date.
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FDA removes clinical hold on Greenwich LifeSciences' Flamingo-01 Phase III trial
FDA formally removed the clinical hold on July 11, 2022, allowing the Flamingo-01 Phase III trial to proceed.
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Greenwich LifeSciences enters $100M ATM equity offering agreement with Jefferies
Entered Open Market Sale Agreement with Jefferies LLC for at-the-market offering of common stock up to $100M.
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FDA placed clinical hold on Flamingo-01 trial for GLSI-100 (GP2) in HER2/neu positive patients, citing manufacturing issues.
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22.8% of 145 patients had positive baseline DTH response to GP2; 24.2% recurrence rate over 5 years (median 99 days).
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Combined analysis of 5-year Phase IIb data shows no recurrences in HER2/neu 3+ patients receiving 6 primary injections (p=0.0338).
Materiality & sentiment trend
Max materiality 0.80 · Median 0.47 · Most common event other_material