Bicycle Therapeutics (BCYC) Morgan Stanley 23rd Annual Global Healthcare Conference summary

Board and leadership updates

• Two new board members with extensive oncology experience were appointed, enhancing expertise in drug development and commercialization.

• Recent board additions aim to build a world-class oncology-focused leadership team.

Zelanectide pevedotin clinical progress and differentiation

• Zelanectide pevedotin targets Nectin-4 and demonstrates efficacy comparable to Padcef, with a more favorable safety profile, notably less severe neuropathy and skin toxicity.

• Phase 1 data show a 45% response rate and longer duration of response (11 months) in second-line urothelial cancer, with lower rates of severe adverse events.

• In first-line combination studies, efficacy remains high even in sicker patient populations, with consistent safety advantages.

• Market research indicates 84% of surveyed oncologists would recommend zelanectide pevedotin over Padcef due to its safety and tolerability.

Pivotal trial design and regulatory milestones

• The Duravelo-2 pivotal study includes both first- and second-line metastatic urothelial cancer cohorts, with dose optimization and interim analyses planned.

• A meeting with the FDA is scheduled for Q4 to finalize dose selection and discuss accelerated approval pathways.

• A qualitative update on dose selection and trial progress will be released after the FDA meeting, with detailed data reserved for a future medical meeting.