Crescent Biopharma (CBIO) Morgan Stanley 23rd Annual Global Healthcare Conference summary

Company background and strategy

• Recently entered public markets via reverse merger in June 2024, with a leadership team experienced in immuno-oncology and ADC development.

• Pursuing a dual strategy: next-generation immuno-oncology bi-specifics (CR-001) and antibody-drug conjugates (ADC, CR-002 and CR-003).

• Aims to be a leader in a $100 billion market, focusing on first-in-class opportunities outside lung and fast-following in major markets like lung.

• Well-capitalized with $153 million in cash, providing runway through 2027 and supporting robust clinical development.

• Building an integrated portfolio to address multiple solid tumor indications with both monotherapy and combination approaches.

Pipeline development and clinical plans

• CR-001, a novel bi-specific antibody, is designed for improved stability and potential subcutaneous dosing, with first patient dosing planned for Q1 2026.

• Phase one study will focus on thoracic, GI, and gynecologic cancers, generating data on dose finding, safety, and efficacy by late 2026 to early 2027.

• CR-002, the first ADC asset, is expected to enter the clinic mid-2026, with a focus on validated targets and topoisomerase payloads.

• Clinical operations emphasize global reach, with a focus on both Western and Asian patient populations to address regulatory and efficacy questions.

• Lessons from recent competitor data and study designs are being incorporated to de-risk and accelerate development.

Industry landscape and data monitoring

• Recent data from ibinastinab and other PD-1/VEGF bi-specifics validate the drug class, showing consistent benefit across Asian and non-Asian populations.

• Monitoring key datasets from Harmony, KISA Bio, BioNTech, and Merck Lenovo, with particular focus on efficacy and safety in lung and other solid tumors.

• Emphasizes the importance of robust statistical design and global regulatory alignment for future trials.

• Actively tracking evolving data in small cell, non-small cell lung cancer, and other tumor types to inform strategy.

• Sees opportunity for differentiation by leveraging both bi-specific and ADC assets in combination regimens.