Company: CNTB
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001835268-25-000035
Chunk: 82

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-05-15
Form: 10-Q
Item: Part II, Item 2
Chunk 82
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 to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Overview

Connect Biopharma, headquartered in San Diego, California, is a clinical-stage biopharmaceutical company focused on advancing rademikibart, a potentially best-in-class next generation IL-4Rα antibody, to transform acute and chronic care in asthma and COPD.

Significant Developments

The following is a summary of significant developments affecting our business that occurred since the filing of our 2024 Annual Report. For additional information or for a more comprehensive discussion of our product candidate, rademikibart, see our 2024 Annual Report.

In March 2025, we announced the publication of positive data from our global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma in the American Journal of Respiratory and Critical Care Medicine. These data highlight rademikibart’s potential as a novel biologic treatment option for patients with asthma and Type 2 inflammation, demonstrating rapid onset of action, sustained improvement in forced expiratory volume in one second and clinically important reductions in annual exacerbation rates.

In April 2025, we announced positive feedback from our Type C meeting with the U.S. Food and Drug Administration (the “FDA”), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation. We obtained the FDA’s alignment on the design of our two parallel Phase 2 trials evaluating rademikibart in patients experiencing an acute exacerbation of asthma or COPD. This treatment setting is of particular interest because available Standard of Care (“SoC”) therapy in the acute setting shows insufficient long-term treatment effect on symptoms and lung function, with frequent exacerbations leading to re-visits by patients to the acute care setting for respiratory critical care treatment. Preventing and delaying recurrent exacerbations in the first 28 days following an exacerbation is a significant unmet medical need and a crucial therapeutic goal in asthma and COPD. Despite current guideline recommendations, treatment with systemic corticosteroids and antibiotics is not wholly adequate.

In May 2025, we announced enrollment of the first patient in our rademikibart Phase 2 clinical trial in patients experiencing an acute exacerbation of asthma or COPD. The Phase 2 acute asthma trial, Seabreeze STAT ASTHMA, and the acute COPD trial, Seabreeze STAT COPD,