Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 554

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 554
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 and consultants, stock-based compensation for R&D employees and consultants, and other outside expenses. Cara’s R&D expenses also included expenses related to preclinical activities for Cara’s earlier stage programs in prior periods and may include such expenses in the future.

R&D costs are expensed as incurred. Non-refundable advance payments for goods or services to be received in the future for use in R&D activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Most of Cara’s R&D costs have been external costs, which Cara tracks on a program-by program basis. Cara’s internal R&D costs are primarily compensation expenses for Cara’s full-time R&D employees. Cara does not track internal R&D costs on a program-by-program basis.

R&D activities have been central to Cara’s business model. Based on Cara’s recent announcement that it is discontinuing its NP program, Cara presently expects that its R&D expenses will significantly decrease in the future as it focuses on exploring strategic alternatives to maximize shareholder value. However, it is difficult to determine with certainty the duration and completion costs in connection with the discontinuation of Cara’s studies in NP or future nonclinical and clinical studies of Cara’s current or any future product candidates, should Cara resume the development of any future product candidates, or if, when or to what extent Cara will generate revenues from the commercialization and sale of any of Cara’s product candidates that obtain regulatory approval, should Cara resume the development of any future product candidates. Cara may never succeed in achieving regulatory approval for oral difelikefalin or any future product candidates, should Cara resume the development of oral difelikefalin or any future product candidates.

The duration, costs and timing of clinical trials and development of future product candidates, should Cara resume the development of any future product candidates, will depend on a variety of factors including, but not limited to:

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per patient trial costs;

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the number of patients that participate in the trials;

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the number of sites included in the trials;

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the countries in which the trial is conducted;

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the length of time required to enroll eligible patients;

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the number of doses that patients receive;

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the drop-out or discontinuation rates of patients;

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potential additional safety monitoring or other studies requested by regulatory agencies;

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the duration of patient follow-up; and

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the efficacy and safety profile of the product candidate.

In addition, the probability of success for future product candidates, should Cara resume the development of any future product candidates,