Company: CNTB
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001835268-25-000014
Chunk: 240

Company: Connect Biopharma Holdings Ltd
Filing Date: 2025-03-31
Form: 10-K
Item: Item 7
Chunk 240
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, to transform care in asthma and chronic obstructive pulmonary disease.

In June 2024, we announced new U.S.-based leadership with the appointment of Barry D. Quart, Pharm.D., as Chief Executive Officer and Director, and David Szekeres, as President. In addition, Kleanthis G. Xanthopoulos, Ph.D. assumed the role of Chairman of the Board. This change in leadership was the first step in transforming Connect into a U.S.-centric company and significantly reducing our footprint in China.

We continued to make progress by (i) assembling an experienced U.S. management team with deep expertise in drug development and regulatory execution, including having collectively received FDA marketing approval for 16 therapeutic products, and with deep expertise in business development, corporate strategy, finance and operations; (ii) developing a rapid clinical development program for rademikibart, which is expected to be initiated in the first half of 2025; (iii) relocating our corporate headquarters to San Diego, California; (iv) transferring the initial manufacturing process of rademikibart to a U.S. CMO; and (v) taking additional steps to become more U.S.-centric, including the voluntary election to become a domestic filer with the SEC, beginning with this Annual Report on Form 10-K.

Critical Accounting Estimates

A summary of the significant accounting policies is provided in Note 2 to our Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K.

The discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. 

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The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. We evaluate our estimates on an ongoing basis, including those related to revenue recognition, accrued research and development expenses, and share-based compensation. We base our estimates on historical experience and on assumptions that we believe to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Management considers an accounting estimate to be critical if: it requires a significant level of estimation uncertainty, and changes in the estimate are reasonably likely to have a material effect on our financial condition or