---
schema_version: "secwatch.filing_event.v1"
accession: "0002023658-25-000112"
form_type: "8-K"
ticker: "BCAX"
cik: "0002023658"
company_name: "Bicara Therapeutics Inc."
filed_at: "2025-12-08T23:59:59+00:00"
generated_at: "2026-05-16T14:07:26.501986+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Bicara reports 57% ORR in Phase 1b expansion; deeper responses at 1500mg dose; dose declaration on track for Q1 2026

## Summary
- 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.

## SEC filing metadata
- accession: 0002023658-25-000112
- form_type: 8-K
- ticker: BCAX
- cik: 0002023658
- company_name: Bicara Therapeutics Inc.
- filed_at: 2025-12-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2023658/000202365825000112/0002023658-25-000112-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2023658/000202365825000112/bcax-20251206.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0002023658-25-000112
- JSON: https://secwatch.observer/filing/0002023658-25-000112.json
- Plain text: https://secwatch.observer/filing/0002023658-25-000112.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.