Connect Biopharma (CNTB) Jefferies Global Healthcare Conference 2025 summary

Strategic focus and management changes

• New, experienced management team refocused efforts on rademikibart, a next-generation IL-4 receptor alpha monoclonal antibody, aiming for a novel acute indication in asthma and COPD.

• Shifted to a U.S.-centric operational model, including new SEC filings and headquarters in San Diego.

• Company maintains global rights outside China, where a partnership with Simcere is advancing parallel development.

• Sufficient cash runway to support current plans through 2027.

Clinical development and data highlights

• Rademikibart demonstrated rapid and significant FEV1 improvement in phase 2 asthma trials, with over 70% of benefit seen within 24 hours.

• Acute use studies in asthma and COPD (CBREST trials) are underway, targeting 160 patients each, with data expected in the first half of next year.

• Product shows differentiated safety profile, with a decline in eosinophils versus increases seen with Dupilumab.

• Market research indicates strong clinician preference for both acute and chronic use if acute efficacy is demonstrated.

Market opportunity and regulatory pathway

• Acute exacerbation in asthma and COPD represents a large, underserved market with over 2 million annual emergency visits in the U.S. alone.

• No biologics are currently approved for acute indications; rademikibart could be first-in-class.

• FDA has agreed to the acute study design; phase 3 readiness for chronic indications is on hold pending acute data.

• Patent exclusivity expected to extend beyond 2040.