Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 16

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 16
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 substantial additional funding in order to maintain its continuing operations. If the Company is unable to raise capital when needed or on acceptable terms, it may be forced to delay, reduce or eliminate one or more of its research and drug development programs or future commercialization efforts.

9

As of June 30, 2025, Legacy Tvardi had cash and cash equivalents and short-term investments of approximately $20.6 million and $20.3 million, respectively, and the Company will require additional capital in order to complete clinical development of any of its current programs. The Company’s monthly spending levels will vary based on new and ongoing development and corporate activities. Because the length of time and activities associated with development of its product candidates is highly uncertain, the Company is unable to estimate the actual funds it will require for development, marketing and commercialization activities. The Company’s future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

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

| ● | the clinical development plans the Company establishes for its product candidates; |

| ● | the timelines of its 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 its product candidates at clinical and, if approved, commercial scales; |

| ● | the number and characteristics of product candidates that the Company develops; |

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

| ● | whether the Company 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 patent claims and other intellectual property rights, including patent infringement actions brought by third parties against the Company 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 the Company may receive regulatory approval in regions where it chooses to commercialize its products on its