Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 147

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 147
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 of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

| ● | the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our potential future product candidates; |

| ● | the clinical development plans we establish for our product candidates; |

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| ● | the timelines of our clinical trials and the overall costs to conduct and complete the clinical trials, including any increased costs due to disruptions caused by marketplace conditions, including the effects of health epidemics, or other geopolitical and macroeconomic conditions; |

| ● | the cost and capital commitments required for manufacturing our product candidates at clinical and if, approved, commercial scales; |

| ● | the number and characteristics of product candidates that we develop; |

| ● | the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities; |

| ● | whether we are 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 our patent claims and other intellectual property rights, including patent infringement actions brought by third parties against us or our 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 we may receive regulatory approval in regions where we choose to commercialize our products on our own. |

A change in the outcome of any of these or other variables with respect to the development of any of our 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” in this prospectus for additional risks associated with our substantial capital requirements. Cash Flows The following table summarizes our cash flows for the periods indicated (in thousands):

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 Six Months Ended 
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 2025             |        ​ 
 June 30, | ​ | ​    
 2024 |      ​ | ​ 
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 2024 |                       ​ 
 Year Ended December 31, | ​ | ​    
 2023 |       ​ |
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