Crescent Biopharma (CBIO) investor relations material

Strategic vision and pipeline overview

• Focused on becoming a leading oncology biotech through a dual strategy: developing CR-001 as a backbone IO therapy and advancing ADC combinations for synergistic effects.

• Four to five clinical studies across three programs (CR-001, CR-002, CR-003) are set to start by 2026, with major data readouts beginning in Q1 2027.

• CR-001 entered the clinic in February, with monotherapy and combination data expected in 2027; CR-002 and CR-003 will also generate key data in 2027.

• The current financial runway extends into 2028, covering all planned milestones and data generation.

• Strong partnership with Kelun-Biotech enables rapid data generation and access to a robust ADC pipeline.

Clinical development and differentiation

• CR-001 aims to be a next-generation backbone therapy, targeting over 40 labeled indications and a $100 billion+ market opportunity.

• Differentiation is achieved through proprietary engineering for higher stability and concentration, enabling lifecycle management and subcutaneous administration.

• The ASCEND phase I/II trial is designed to optimize dosing, assess safety/efficacy, and inform registration-enabling trials across multiple indications.

• Data from global and China studies will guide indication selection based on probability of success, speed to market, and portfolio fit.

• Focus areas include GI, thoracic, and reproductive cancers, leveraging the matrix portfolio.

Competitive landscape and scientific rationale

• Landmark data from competitors (e.g., HARMONi-6, ivonescimab) validate the bispecific approach, showing significant PFS and OS benefits and strong safety profiles.

• CR-001 is designed to match or exceed these benchmarks, with improved stability and global trial design.

• Bispecifics offer advantages over separate PD-1 and VEGF therapies, including efficacy in populations where monotherapies failed and improved safety in squamous NSCLC.

• The global market remains wide open, with no bispecific approvals outside China, presenting significant opportunity.

• Lessons from competitor trials inform study design and stratification to maximize success.