Crescent Biopharma (CBIO) Stifel 2025 Healthcare Conference summary

Company vision and strategy

• Aims to build a leading biotech and oncology company with a dual strategy: next-gen IO backbone (CR-001) and best-in-class ADC combinations.

• CR-001 is a PD-1/VEGF bispecific designed to replicate ivonescimab’s pharmacology, with improved stability and subcutaneous delivery.

• Aggressive ADC development, with CR-002 entering clinic mid-next year and additional assets in the pipeline.

• Well-capitalized with $133 million in cash, supporting operations through 2027 and key clinical readouts.

• Focused on leveraging existing phase III data to accelerate development and de-risk clinical programs.

Clinical development plans and milestones

• CR-001 to enter clinic in the next few months, aiming for proof-of-concept data by late 2026 or early 2027.

• First-in-human trial will be global (ex-China), with robust dose escalation and optimization to maximize probability of success.

• Indication prioritization targets thoracic, GI, and reproductive cancers, with flexibility to expand based on data.

• ADC program avoids novel biology risk initially, focusing on optimizing known targets for best-in-class combinations.

• Combination strategies will explore both internal and external ADCs with CR-001 across multiple indications.

Data, differentiation, and competitive landscape

• SITC data demonstrated CR-001’s in vitro and in vivo pharmacology matches ivonescimab, with improved stability.

• Preclinical and NHP PK data support functional similarity, aiming to replicate ivonescimab’s clinical profile.

• Learning from prior PD-1/PD-L1 development strategies, focusing on robust study design, global execution, and regulatory alignment.

• Avoiding pitfalls of China-first studies by starting globally, aiming for seamless execution and regulatory efficiency.

• Monitoring competitor moves in lung and colorectal cancer, viewing recent developments as validation of their approach.