Company: CNTB
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001835268-25-000014
Chunk: 90

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 90
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 additional information is acquired;

•the costs and timing of manufacturing for our Product Candidates, including commercial manufacturing if any Product Candidate is approved;

•the costs, timing and outcome of regulatory review of our Product Candidates;

•the costs of obtaining, maintaining, enforcing and defending our patents and other intellectual property and proprietary rights and resolving disputes related to third parties’ intellectual property and proprietary rights;

•our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal controls over financial reporting;

•the costs associated with hiring additional personnel and consultants as our clinical activities increase;

•the timing and amount of the royalty or other payments we must make to our licensors and other third parties;

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•the costs and timing of establishing or securing sales and marketing capabilities if any Product Candidate is approved or in anticipation of approval;

•our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;

•the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and

•costs associated with any Product Candidates, products or technologies that we may in-license or acquire.

Conducting clinical trials and preclinical studies is a time consuming, expensive and uncertain process that takes years to complete, and we might never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, our Product Candidates, if approved, might not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if at all.

Accordingly, we might need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing might not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, limit, reduce or terminate our product development, or future commercialization efforts or grant third-parties rights to develop and market Product Candidates that we would otherwise have the potential to develop and market ourselves. Our ability to grow and support our business and to respond to market challenges could be significantly limited in these circumstances, which could have a material adverse effect on our business, financial condition and results of operations.

Additionally, we maintain most of our cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions exceed insured limits. Market conditions can impact the viability of these institutions. For