Company: TVRD
Filing Date: 2025-10-20
Form Type: S-1/A
Source: 0001104659-25-100896
Chunk: 123

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-20
Form: S-1/A
Chunk 123
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 These statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained in this prospectus, the Company cautions you that these statements are based on a combination of facts and factors currently known by the Company and its expectations of the future, about which the Company cannot be certain.

The forward-looking statements in this prospectus include, among other things, statements about:

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the Company’s ability to continue as a going concern;

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the Company’s ability to realize the anticipated benefits of the Merger;

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the impact of any legal proceedings that may be instituted against Cara, Legacy Tvardi, the Company or any of each company’s respective directors or officers related to the Merger Agreement, or the transactions associated with the Merger Agreement;

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substantial uncertainties regarding whether the Merger Agreement and transactions associated with the Merger Agreement will generate value for stockholders;

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the Company’s ability to maintain compliance with Nasdaq listing requirements;

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the expectations surrounding the potential safety, efficacy, and regulatory and clinical progress of the Company’s product candidates, including TTI-101 and TTI-109, and anticipated milestones and timing therefor;

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the Company’s plans to develop and commercialize its product candidates or any potential future product candidates;

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the potential results of preclinical studies and clinical trials and future regulatory and development milestones for the Company’s product candidates or any potential future product candidates;

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the performance of third-party manufacturers, clinical research organizations, and other vendors;

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the size and growth of the potential markets for the Company’s product candidates;

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the rate and degree of market acceptance of any other future approved indications or products;

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the Company’s ability to obtain and maintain additional regulatory approval of its product candidates or any future product candidates, and the labeling under any approval the Company may obtain;

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the Company’s ability to maintain existing and establish additional collaborations for its product candidates or future product candidates;

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the continued service of the Company’s key scientific or management personnel;

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the Company’s ability to establish commercialization and marketing capabilities for any future approved products;

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regulatory developments in the United States and foreign countries;

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the Company’s ability to obtain and maintain coverage and adequate reimbursement from third-party payers and governments for any other future approved indications or products;

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the Company’s planned use of its cash and cash equivalents