Zelenectide pevedotin (BT8009) - (Duravelo-1)

January 12, 2026: Bicycle Therapeutics plc (NASDAQ: BCYC) provided a 2025 pipeline update and outlined 2026 catalyst milestones across its Nectin-4, EphA2, and radioconjugate programs.

Nectin-4 pipeline (zelenectide pevedotin/BT8009; BT7480)

• Metastatic urothelial cancer (mUC): Company expects dose selection from the Phase 2/3 Duravelo-2 pivotal trial and an update on the potential approval pathway for zelenectide pevedotin in 1Q 2026 following meetings with multiple regulatory agencies. Dose selection data from Duravelo-2 (zelenectide pevedotin + pembrolizumab) is planned for presentation at a scientific conference in 1H 2026.
• Duravelo-1 (mUC): Additional Phase 1 combination data with pembrolizumab in first-line cisplatin-ineligible mUC, and longer-term follow-up monotherapy data in late-line mUC, are planned for 1H 2026 conference presentation.
• Breast cancer: Initial data from the Phase 1/2 Duravelo-3 trial in NECTIN4-amplified breast cancer is expected in 2H 2026. The Phase 1/2 Duravelo-4 trial in NECTIN4-amplified NSCLC was initiated in 2025.
• BT7480: Phase 1 combination data with nivolumab is planned for 1H 2026 conference presentation.

EphA2 pipeline (BT5528; EphA2 imaging)

• BT5528: Phase 1 combination data with nivolumab in mUC and an update on future clinical development plans are expected in 1H 2026.
• Imaging: Additional EphA2 human imaging data is planned for 1H 2026.

Radiopharmaceutical supply chain

• Reported collaborations with the UK Nuclear Decommissioning Authority, UK National Nuclear Laboratory, and SpectronRx to support an end-to-end supply chain for 212Pb, alongside existing 177Lu and 68Ga supply chains.