secwatch.observer — SEC 8-K summary
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Issuer:     Tempest Therapeutics, Inc. (TPST)
CIK:        0001544227
Form:       8-K
Filed at:   2024-11-12T23:59:59+00:00
Accession:  0000950170-24-125444
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tempest reports Q3 net loss $10.6M; gets FDA go-ahead for amezalpat Phase 3 in first-line HCC
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1544227/000095017024125444/0000950170-24-125444-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1544227/000095017024125444/tpst-20241112.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-125444

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer