---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-003026"
form_type: "8-K"
ticker: "BCYC"
cik: "0001761612"
company_name: "BICYCLE THERAPEUTICS PLC"
filed_at: "2025-01-13T23:59:59+00:00"
generated_at: "2026-05-28T03:41:11.509179+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Bicycle Therapeutics reports 65% ORR in Ph1 combo zelenectide plus pembro in 1L mUC; outlines 2025 milestones

## Summary
- Updated Phase 1 Duravelo-1 data: 65% ORR (13/20 evaluable) in 1L cisplatin-ineligible mUC; 50% confirmed ORR.
- Median duration of response not yet mature; 12 patients remain on treatment at data cut-off (Jan 3, 2025).
- No Grade 4/5 TRAEs of clinical interest; no patients withdrew due to zelenectide TRAEs; low-grade peripheral neuropathy, skin/eye events.
- Cash and equivalents $890.9M as of Sept 30, 2024; financial runway into 2H 2027.
- 2025 milestones: Phase 2/3 Duravelo-2 dose selection data in 2H; initiate Phase 1 trials in NECTIN4-amplified breast, lung, and multi-tumor cancers.

## SEC filing metadata
- accession: 0001104659-25-003026
- form_type: 8-K
- ticker: BCYC
- cik: 0001761612
- company_name: BICYCLE THERAPEUTICS PLC
- filed_at: 2025-01-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1761612/000110465925003026/0001104659-25-003026-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1761612/000110465925003026/tm253122d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-003026
- JSON: https://secwatch.observer/filing/0001104659-25-003026.json
- Plain text: https://secwatch.observer/filing/0001104659-25-003026.txt

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