Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 82

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 82
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 in the future it may never receive such regulatory approval for oral difelikefalin or any future product candidates.

Should Cara resume development of its product candidate or any future product candidates, the success of such product candidates will depend on many factors, including but not limited to:

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successful enrollment in, and completion of, clinical trials, as well as completion of preclinical studies;

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favorable efficacy and acceptable safety data from Cara’s clinical trials and other studies;

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receipt of additional regulatory approvals;

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managing Cara’s reliance on sole-source third parties such as its third-party vendors, suppliers, and manufacturers;

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the performance by CROs or other third parties and consultants Cara may retain of their duties to Cara in a manner that complies with its protocols and applicable laws and that protects the integrity of the resulting data;

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obtaining and maintaining patent, trade secret and other intellectual property protection and regulatory exclusivity;

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ensuring Cara does not infringe, misappropriate or otherwise violate the valid patent, trade secret or other intellectual property rights of third parties;

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successfully launching, either alone or with a commercial partner, any product candidate for which regulatory approval is received;

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obtaining and maintaining favorable reimbursement from third-party payers and governments for products and product candidates;

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competition with other products;

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post-marketing commitments, if any, to regulatory agencies following regulatory approval of any product candidate;

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continued acceptable safety profile following regulatory approval; and

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manufacturing or obtaining sufficient supplies of Cara’s products and any product candidate that may be necessary for use in clinical trials for evaluation of any product candidate and commercialization of any approved product.

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If Cara does not achieve and maintain one or more of these factors in a timely manner or at all, Cara could experience significant delays in its ability to, or be unable to obtain regulatory approvals for, and/or to successfully commercialize any products or product candidates, should Cara resume development of its product candidate or any future product candidate, which would materially harm Cara’s business and Cara may not be able to generate sufficient revenues and cash flows to continue its operations.

Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Should Cara resume development of its product candidate or any potential future product candidate, such product candidate may not achieve favorable results in clinical trials or preclinical studies or receive regulatory approval on a timely