---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-26-001766"
form_type: "8-K"
ticker: "BCAX"
cik: "0002023658"
company_name: "Bicara Therapeutics Inc."
filed_at: "2026-01-12T23:59:59+00:00"
generated_at: "2026-05-16T10:58:25.406434+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Bicara selects 1500 mg ficerafusp alfa dose for Phase 3 pivotal HNSCC study

## Summary
- Selected 1500 mg QW ficerafusp alfa plus pembrolizumab as optimal dose for Phase 3 FORTIFI-HN01 in 1L HPV-negative R/M HNSCC.
- Expects substantial enrollment by end-2026 to enable interim analysis mid-2027 for potential accelerated filing.
- Plans to present Phase 1b expansion data in 1L HNSCC (Q1 2026) and long-term follow-up (Q2 2026).
- Will explore ficerafusp alfa in other solid tumors; Phase 1b mCRC data expected H2 2026.
- Planning critical commercial hires in 2026, including Chief Commercial Officer, to prepare for launch.

## SEC filing metadata
- accession: 0001628280-26-001766
- form_type: 8-K
- ticker: BCAX
- cik: 0002023658
- company_name: Bicara Therapeutics Inc.
- filed_at: 2026-01-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2023658/000162828026001766/0001628280-26-001766-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2023658/000162828026001766/bcax-20260112.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-26-001766
- JSON: https://secwatch.observer/filing/0001628280-26-001766.json
- Plain text: https://secwatch.observer/filing/0001628280-26-001766.txt

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