Crescent Biopharma (CBIO) investor relations material

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).

• Focused on building a portfolio of first-in-class and fast-follower opportunities, especially outside of lung cancer.

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

• Aims to become a leading biotech oncology company, targeting significant market redistribution in the sector.

Pipeline development and clinical plans

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

• Initial clinical focus areas include thoracic, gastrointestinal, and gynecological cancers, with a robust phase one study planned.

• Key data readouts targeted for late 2026 to early 2027, covering dose finding, safety, PK, and early efficacy in both monotherapy and combination settings.

• ADC pipeline leverages validated targets and topoisomerase payloads, aiming for synergy with CR-001 and broad application across solid tumors.

• Plans to advance CR-002 into the clinic by mid-2026, with flexibility to pursue both internal and external ADC combinations.

Industry data and competitive landscape

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

• Monitoring key datasets from Harmony, BioNTech, and Merck Lenovo molecules, which are most relevant to their strategy.

• Lessons from competitor studies inform clinical design, especially regarding statistical assumptions and regulatory requirements.

• U.S. clinical sites are eager to participate, as most prior studies have focused on Asian populations.

• The company is positioned as a leader in bringing bi-specifics to Western populations, with a global clinical footprint planned.