Bicycle Therapeutics (BCYC) Goldman Sachs 45th Annual Global Healthcare Conference summary

Platform overview and differentiation

• Utilizes a small, synthetic constrained peptide platform based on Nobel Prize-winning science, enabling delivery to targets inaccessible to larger molecules.

• Platform allows for fine-tuning by disease and indication, supporting applications in toxin conjugates, immuno-oncology, and radionuclide therapies.

• Demonstrates a differentiated safety profile, with clinical data in hundreds of patients showing improved tolerability and potential to address undruggable targets.

• Lead asset BT8009 targets Nectin-4 and is in global phase II/III trials, with additional assets BT5528 (EphA2) and BT7480 (Nectin IO, CD137) in development.

• Multiple catalysts and milestones are expected in the second half of the year across the pipeline.

Recent clinical data and ASCO highlights

• ASCO data highlighted enhanced safety and precision of Bicycles, with PK profiles showing short systemic half-life but prolonged tumor exposure.

• BT8009 and BT5528 demonstrated similar PK profiles, indicating platform stability across targets.

• Clinical data for BT8009 showed a 38% response rate and 11.1 months duration of response, potentially exceeding competitor benchmarks.

• Safety profile for BT8009 showed no grade 3 toxicities in key adverse events among 113 patients, with lower incidence of all-grade events compared to competitors.

• Median dose intensity for BT8009 is about 90%, higher than competitors, supporting longer treatment duration.

Duravelo-2 trial design and regulatory strategy

• Duravelo-2 is a phase II/III global trial with 300 sites, studying two doses in first-line and second-line settings, using avelumab and chemo as comparators.

• Primary accelerated endpoint is overall response rate; secondary endpoints include PFS and OS.

• Trial design aligned with FDA guidance and Project FrontRunner, aiming for robust evidence without shortcuts.

• Trial began in Q1 2024, with evolving standards of care considered in design and comparator selection.