earnings
confidence high
sentiment positive
materiality 0.75
Tempest reports Q3 net loss $10.6M; gets FDA go-ahead for amezalpat Phase 3 in first-line HCC
Tempest Therapeutics, Inc.
2024-Q3 EPS reported
-$1.19
- Net loss of $10.6M ($0.41/sh) in Q3 2024 vs $6.8M ($0.48) in Q3 2023; cash $22.1M, then raised $19.9M net via ATM.
- FDA issued 'Study May Proceed' letter for pivotal Phase 3 trial of amezalpat + atezolizumab + bevacizumab in first-line HCC.
- Announced agreement with Roche to supply atezolizumab globally for the Phase 3 trial; Tempest retains all rights to amezalpat.
- Positive end-of-Phase 2 FDA meeting: agreement on Phase 3 design, dose, statistical plan with early efficacy analysis.
- Expanded leadership: Troy M. Wagner as VP Quality Assurance and Sheldon Mullins as VP Regulatory Affairs.