Connect Biopharma (CNTB) H.C. Wainwright 28th Annual Global Investment Conference summary

Key study results and clinical insights

• Seabreeze asthma study demonstrated rapid, statistically significant improvement in lung function at day seven, even on top of aggressive background therapy.

• Despite a 66% reduction in treatment failure, statistical significance was missed due to a lower-than-expected event rate in the placebo group.

• The study validated previous findings of rapid FEV1 improvement and reduction in exacerbation rates, supporting progression to phase III.

• Acute endpoint selection remains challenging, with FEV1 favored over treatment failure due to low event rates in the first week post-exacerbation.

• IV dosing showed strong early response, potentially enabling even faster onset of benefit for acute indications.

Regulatory and development strategy

• Plans are in place to meet with the FDA late this year, aiming to initiate phase III trials early next year.

• The FDA has acknowledged the unmet need and engaged positively, though it has not provided explicit guidance for acute asthma indications.

• FEV1 is expected to be an acceptable primary endpoint for approval, based on precedent and agency interest in rapid onset of effect.

• Acute studies are prioritized due to unique drug attributes, with chronic studies to follow after regulatory discussions.

Market opportunity and health economics

• Recent U.S. claims data indicate a larger-than-expected addressable market, with 1.6 million high T2 asthma patients visiting the ED for acute exacerbations in 2025.

• Hospital readmission rates for these patients are 17%-20% within 30 days, representing significant economic burden.

• A drug achieving a 66% reduction in treatment failure could generate substantial cost savings for hospitals.

• COPD presents an even greater opportunity for modeling cost savings due to higher event rates and more hospitalizations.