Company: CNTB
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001835268-25-000014
Chunk: 104

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 104
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 of applicable regulatory authorities;

•receipt of marketing approvals from applicable regulatory authorities, including of NDAs or BLAs from the FDA or of similar regulatory filings from the NMPA or comparable foreign regulatory authorities, and maintaining such approvals;

•making arrangements with our third-party manufacturers for, or establishing, commercial manufacturing capabilities;

•establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;

•establishment, maintenance, enforcement and defense of patent, trade secret and other intellectual property and proprietary protection or regulatory exclusivity for our Product Candidates;

•maintaining an acceptable safety, tolerability and efficacy profile of our products following approval, if any;

•acceptance of our products, if and when approved, by patients, the medical community and third-party payors; 

•manufacturing our Product Candidates at an acceptable cost; and

•maintaining and growing an organization of people who can develop our products and technology.

The success of our business, including our ability to finance our business and generate any revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of our Product Candidates, which may never occur. We may not succeed in demonstrating the safety or efficacy for all Product Candidates in clinical trials or in obtaining marketing approval thereafter. If we are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our Product Candidates, we may not be able to generate sufficient revenue to continue our business.

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Our approach to the discovery and development of Product Candidates based on potent T cell modulation activity is unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our Product Candidates or render our approach obsolete.

The success of our business depends primarily upon our ability to identify, develop and commercialize products based on the rapid identification of molecules with potent T cell modulation activity, which is a novel and unproven approach. Our drug screening approach is designed to enable us to identify and develop Product Candidates targeting multiple allergic and autoimmune diseases.

While we believe our preclinical, Phase 1 and/or Phase 2 results for rademikibart were supportive of further clinical development, we have not yet succeeded and may never succeed in demonstrating the safety and efficacy of rademikibart or any other Product Candidates in a manner sufficient to obtain marketing approval. We currently do not have any other Product Candidates in clinical development.

Our approach to