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Bicycle Therapeutics (BCYC) investor relations material

Bicycle Therapeutics Jefferies London Healthcare Conference 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Jefferies London Healthcare Conference 2025 summary18 Nov, 2025

Technology platform and pipeline

  • Bicyclic peptides offer high affinity and selectivity, enabling targeted delivery of various payloads, especially toxin and radio conjugates.

  • Lead asset zelenectide pevedotin targets Nectin-4 and is in pivotal phase 2/3 trials for bladder cancer, with additional studies in other tumor types.

  • BT5528 targets EphA2, a historically challenging antigen, and has shown a favorable safety profile in over 160 patients.

  • Radio conjugate programs leverage isotope-agnostic approaches and a broad target bank, aiming for rapid tumor penetration and short systemic half-life.

  • The platform's versatility allows for payloads including small molecules, cells, and imaging agents, supporting next-generation drug development.

Clinical data and differentiation

  • Zelenectide pevedotin has shown comparable efficacy to Padcev in phase 1, with improved safety, notably reduced neuropathy and skin toxicity.

  • Market research indicates strong physician preference for zelenectide plus pembrolizumab if safety improvements are confirmed.

  • Nectin-4 amplification identified in 20-30% of bladder, breast, and lung cancers; selecting for this biomarker increases response rates to 40-60%.

  • BT5528 has not shown the coagulopathy seen with other EphA2-targeting ADCs, and imaging data confirm target engagement in pancreatic cancer.

  • Significant updates for BT5528 are expected at a medical conference in the first half of 2026.

Regulatory and development strategy

  • The pivotal Duravelo-2 study for zelenectide pevedotin is a seamless phase 2/3 design, with dose optimization and global regulatory alignment.

  • Timeline for phase 2 data readout shifted from Q4 2025 to Q1 2026 to ensure feedback from FDA, EMA, and MHRA.

  • Accelerated approval will be sought based on ORR, with confirmatory data for full approval; top-line data will be released only if efficacy and safety meet internal benchmarks.

  • Data presentations are planned for medical meetings to provide comprehensive and mature datasets.

  • Studies in Nectin-4 amplified tumors are actively enrolling, with assay development and regulatory clearance completed.

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Q4 202524 Feb, 2026
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Frequently asked questions

Bicycle Therapeutics plc is a clinical-stage biopharmaceutical company focused on developing a novel class of medicines known as Bicycle molecules. These molecules are fully synthetic short peptides constrained by small molecule scaffolds, forming two loops that stabilize their structure. This design allows them to bind to targets with high affinity and selectivity, making them promising candidates for drug development, particularly in areas where existing therapeutics are lacking. Bicycle Therapeutics is headquartered in Cambridge, UK, with significant operations in Cambridge, Massachusetts. Its shares are listed on NASDAQ.

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