secwatch.observer — SEC 8-K summary
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Issuer:     Bicara Therapeutics Inc. (BCAX)
CIK:        0002023658
Form:       8-K
Filed at:   2025-12-08T23:59:59+00:00
Accession:  0002023658-25-000112
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Bicara reports 57% ORR in Phase 1b expansion; deeper responses at 1500mg dose; dose declaration on track for Q1 2026
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- 750mg ficerafusp alfa + pembrolizumab showed 57% confirmed ORR (17/30) with 10% complete response.
- At 1500mg, median depth of response was 82% vs 63% at 750mg at 24 weeks.
- Deep response rate (≥80% shrinkage) was 64% at 1500mg vs 27% at 750mg.
- Safety profile consistent with known safety; no new tolerability concerns.
- Company on track to declare optimal biologic dose for pivotal FORTIFI-HN01 study in Q1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2023658/000202365825000112/0002023658-25-000112-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2023658/000202365825000112/bcax-20251206.htm
  HTML page:      https://secwatch.observer/filing/0002023658-25-000112

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