Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 617

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 617
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 including the effects of health epidemics, or other geopolitical and macroeconomic conditions; • the cost and capital commitments required for manufacturing its product candidates at clinical and if, approved, commercial scales; • the number and characteristics of product candidates that Tvardi develops; • the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities; • whether Tvardi is able to enter into future collaboration agreements and the terms of any such agreements; • the ability to achieve and timing of achieving a favorable pricing and reimbursement decision by the pricing authorities in the markets of interest; • the cost of filing, prosecuting, defending and enforcing its patent claims and other intellectual property rights, including patent infringement actions brought by third parties against Tvardi or its product candidates; • the effect of competing technological and market developments; • the cost and timing of completion of commercial-scale outsourced manufacturing activities; and • the cost of establishing sales, marketing and distribution capabilities for any product candidates for which Tvardi may receive regulatory approval in regions where it chooses to commercialize its products on its own. A change in the outcome of any of these or other variables with respect to the development of any of Tvardi’s current and future product candidates could significantly change the costs and timing associated with the development of that product candidate. See the section titled “Risk Factors” for additional risks associated with Tvardi’s substantial capital requirements. Cash Flows The following table summarizes Tvardi’s cash flows for the periods indicated (in thousands):

| ​                                                   
 ​                                                   | ​ 
 ​ | ​ 
 ​ | Nine Months EndedSeptember 30, 
 2024                           |   |         |   | ​ | ​ | 2023 |   |         |   | ​ 
 ​ | ​ 
 ​ | Year Ended December 31, 
 2023                    |   |         |   | ​ | ​ | 2022 |   |         |   | ​ 
 ​ |
|:----------------------------------------------------|:--|:--|:-------------------------------|:--|--------:|:--|:--|:--|:-----|:--|--------:|:--|:--|:--|:------------------------|:--|--------:|:--|:--|:--|:-----|:--|--------:|:--|:--|
| Net cash used in operating activities               | ​ | ​ | ​                              | $ | -13,472 | ​ | ​ | ​ | ​