Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 555

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 555
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4. For the three months ended September 30, 2023, Cara recorded commercial supply revenue of $1.3 million, with associated COGS of $1.6 million. For the nine months ended September 30, 2024 and 2023, Cara recorded commercial supply revenue of $0.6 million and $5.8 million, respectively, with associated COGS of $0.6 million for the 2024 period and $5.6 million for the 2023 period. Cara expects its COGS to be reflective of future KORSUVA injection sales.

#### Research and Development
Cara’s R&D expenses relate primarily to the development of oral difelikefalin. R&D expenses consist of expenses incurred in performing R&D activities, including compensation and benefits for full-time R&D

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employees, clinical trial and related clinical manufacturing expenses, third-party formulation expenses or milestone payments, fees paid to CROs and other vendors 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