Company: CNTB
Filing Date: 2025-04-01
Form Type: 8-K
Source: 0001835268-25-000019
Chunk: 1

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-04-01
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

Based on advice from the FDA at the Type C Meeting, the Company plans to begin enrolling patients in parallel Phase 2 trials of rademikibart in patients with moderate-to-severe asthma or chronic obstructive pulmonary disease (“ COPD”) experiencing an acute exacerbation during the second quarter of 2025.

The two parallel Phase 2 randomized, double-blind, placebo-controlled trials are expected to each enroll approximately 160 patients and include patients with uncontrolled, moderate-to-severe asthma or COPD with eosinophils ≥300 cells/µ L who are experiencing an acute exacerbation. The trials are designed to evaluate the benefits of a single 600 mg subcutaneous dose of rademikibart in patients over 28 days following an acute exacerbation. The Company expects to report data from both rademikibart Phase 2 trials in the first half of 2026.

Forward-Looking Statements

This disclosure, including the press release furnished herewith as Exhibit 99.1, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Current Report on Form 8-K. Forward-looking statements contained herein include, but are not limited to, statements regarding the Company’s strategy and plans, the potential clinical effects, benefits, safety and efficacy of rademikibart, the timing, nature and significance of enrollment and data from the Company’s trials evaluating rademikibart, the timing of any further releases of data or of any presentations or investor conference calls, the Company’s plans and expectations for its asthma and COPD program, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by the Company’s competitors; changes in expected or existing competition; delays in or disruptions to the Company’s business or clinical trials