Bicycle Therapeutics (BCYC) investor relations material

Platform and pipeline overview

• Developing a novel synthetic peptide modality (Bicycle molecules) capable of delivering diverse payloads to any target, based on Nobel Prize-winning science and protected by a strong IP portfolio.

• Focused on oncology with multiple clinical molecules, including zelenectide pevedotin for metastatic urothelial cancer (mUC) and a radiopharmaceuticals pipeline targeting MT1-MMP and EphA2.

• Strategic partnerships with major pharma and academic institutions extend platform use into radiopharmaceuticals and neurology.

• Cash and cash equivalents of $648.3M as of September 30, 2025, with expected runway into 2028.

Zelenectide pevedotin clinical progress

• Zelenectide targets Nectin-4, showing superior selectivity, robust activity in multiple tumor models, and reduced skin/eye toxicity.

• In Ph1/2 Duravelo-1, zelenectide demonstrated a 45% ORR in 2L+ EV-naïve mUC and a differentiated safety profile.

• Combination with pembrolizumab in 1L cisplatin-ineligible mUC showed a 50% ORR and 90% disease control rate, with all grade 3 TRAEs reversible and no grade 4/5 events.

• NECTIN4 gene amplification identified as a predictive biomarker, with amplified patients in TNBC and NSCLC showing notably higher ORR and DCR.

• FDA Fast Track designations in mUC, TNBC, and NSCLC; pivotal Ph2/3 trials and regulatory discussions on expedited approval pathways are ongoing.

Radiopharmaceuticals and next-generation pipeline

• Building a robust radioconjugate pipeline with sustainable isotope access and partnerships with Novartis, Bayer, and leading isotope suppliers.

• MT1-MMP and EphA2 identified as novel, first-in-class targets; early human imaging validates MT1-MMP as a promising theranostic target.

• BRC molecules show selective tumor uptake, ideal PK, and minimal systemic exposure across multiple tumor models.

• Additional MT1-MMP and EphA2 human imaging data expected in 2025–2026.