Connect Biopharma (CNTB) Oppenheimer 36th Annual Healthcare Life Sciences Conference summary

Strategic focus and clinical development

• Lead asset Rademikibart targets IL-4Rα and is positioned as a next-generation antibody for asthma and COPD, with completed studies in atopic dermatitis and chronic asthma.

• Licensed to a partner in China, where Phase III atopic dermatitis is complete and a chronic asthma study is ongoing.

• Two ongoing studies target acute exacerbations of asthma and COPD, aiming to address a large, underserved global market.

• Rademikibart’s unique binding profile offers rapid onset and improved efficacy compared to existing biologics, with significant FEV1 improvements observed within 24 hours.

• IV administration is being explored to further accelerate onset, with initial safety and PK data expected soon.

Market opportunity and differentiation

• Acute exacerbations represent a major unmet need, with millions of ER visits annually and no approved biologics for acute treatment.

• Rademikibart shows a differentiated mechanism, reducing eosinophil levels and enhancing beta-agonist response, unlike dupilumab.

• Market research indicates 40-45% preference share for acute use among patients not on biologics, with 75% of clinicians likely to continue chronic use after acute administration.

• Acute indication is expected to drive chronic market adoption, with no direct competition due to label restrictions on other biologics.

• Peak sales for acute and chronic indications are forecasted at up to $5 billion globally, excluding additional indications.

Regulatory and commercial outlook

• Acute studies are designed for rapid readout, with endpoints focused on FEV1 and treatment failure within two weeks.

• Phase III for acute indications could be completed within a year, with two studies anticipated due to the novel nature of the indication.

• Chronic indication may require only modest bridging studies, leveraging global and China Phase III data.

• Cash runway extends into 2027, with significant milestones and royalties expected from China partnership.

• Anticipated catalysts include IV pharmacology data, Phase II acute results midyear, and potential atopic dermatitis approval in China by Q3.