other material
confidence high
sentiment negative
materiality 0.85
Galera receives FDA CRL for avasopasem, cuts workforce 70%, Q2 net loss $20.7M
Galera Therapeutics, Inc.
- FDA issued Complete Response Letter for avasopasem NDA; additional clinical trial required for resubmission.
- Company reduced workforce by ~70% to extend cash runway into Q2 2024.
- Q2 net loss $(20.7)M, $(0.48) per share; R&D $7.6M, G&A $9.2M.
- Cash, equivalents and investments $38.8M as of June 30, 2023.
- Orphan drug designation for rucosopasem in pancreatic cancer; GRECO trials enrollment ongoing.