Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 585

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 585
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from quarter to quarter and year to year, depending on the timing of Cara’s clinical trials, should Cara resume the development of any future product candidates, and the future sales of KORSUVA.

Cara anticipates that its expenses will be focused on:

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the discontinuation of Cara’s clinical program for oral difelikefalin for chronic pruritus associated with NP; and

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the exploration of strategic alternatives to maximize shareholder value.

Should Cara resume the development of any future product candidate, the successful development of any future product candidate is highly uncertain. As such, at this time, Cara cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the development of any future product candidate, should Cara resume the development of future product candidates. Cara is also unable to predict when, if ever, Cara will generate any further material net cash inflows from difelikefalin or any other future product candidate. This is due to the numerous risks and uncertainties associated with developing medicines, including the uncertainty of:

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successful enrollment in, and completion of clinical trials, should Cara resume the development of any future product candidates;

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receipt of marketing approvals from applicable regulatory authorities, should Cara resume the development of any future product candidates;

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establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers, should Cara resume the development of any future product candidates;

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obtaining and maintaining patent and trade secret protection and regulatory exclusivity for difelikefalin or any future product candidate;

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launching commercial sales of the products, if and when approved, whether alone or in collaboration with others, should Cara resume the development of any future product candidates;

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achieving meaningful penetration in the markets which Cara seeks to serve, should Cara resume the development of any future product candidates; and

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obtaining adequate coverage or reimbursement by third parties, such as commercial payers and government healthcare programs, including Medicare and Medicaid, should Cara resume the development of any future product candidates.

A change in the outcome of any of these variables with respect to the development of oral difelikefalin or any of Cara’s future product candidates, should Cara resume the development of oral difelikefalin or any future product candidates, would significantly change the costs and timing associated with the development of that product candidate. Further, the timing of any of the above may be impacted by global economic conditions and significant global events, should Cara resume the development of oral difelikefalin or any future product candidate, introducing additional