---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-045198"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2026-04-20T23:59:59+00:00"
generated_at: "2026-05-15T05:20:57.669573+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics: nuzefatide 40% ORR in EphA2+ mUC; Phase 2 PDAC trial dosed

## Summary
- Nuzefatide + nivolumab in 14 mUC patients: 40% ORR in EphA2+ tumors; 100% ORR (3/3) in MMAE-naïve EphA2+ tumors.
- Preferred monotherapy dose identified as 8mg/m2 Q2W; first patient dosed in Phase 2 trial for 2L+ pancreatic ductal adenocarcinoma.
- Human imaging data with EphA2 BIA detected PDAC metastases in 15/18 patients; validates EphA2 as a novel target.
- No Grade ≥3 TRAEs of clinical interest with combination; differentiated safety profile vs other EphA2-targeted agents.

## SEC filing metadata
- accession: 0001104659-26-045198
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2026-04-20T23:59:59+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/1761612/000110465926045198/0001104659-26-045198-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465926045198/tm2612166d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-045198
- JSON: https://secwatch.observer/filing/0001104659-26-045198.json
- Plain text: https://secwatch.observer/filing/0001104659-26-045198.txt

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