Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 581

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 581
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 or a suspension or termination of a clinical trial once commenced; |

| ● | conditions imposed by the FDA or comparable foreign regulatory authorities regarding the scope or design of Tvardi’s clinical trials; |

| ● | delays in enrolling subjects in clinical trials, including due to operational challenges or competition with other clinical trials; |

| ● | high drop-out rates or screening failures of subjects from clinical trials; |

| ● | inadequate supply or quality of product candidates or other materials necessary for the conduct of Tvardi’s clinical trials; |

| ● | greater than anticipated clinical trial costs; |

| ● | inability to compete with other therapies; |

| ● | failure to secure or maintain orphan designation in some jurisdictions; |

| ● | unfavorable FDA or other regulatory agency inspection and review of a clinical trial site; |

| ● | failure of Tvardi’s third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all; |

| ● | delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to Tvardi’s technology in particular; or |

| ● | varying interpretations of data by the FDA and other comparable foreign regulatory authorities. |

A change in the outcome of any of these variables with respect to the development of any of Tvardi’s product candidates or potential future product candidates could mean a significant change in the costs and timing associated with the development of that product candidate or potential future product candidate. For example, if the FDA or another regulatory authority were to require Tvardi to conduct clinical trials beyond those that we anticipate would be required for the completion of clinical development of a product candidate or potential future product candidate, or if Tvardi experiences significant delays in its clinical trials due to slower than expected patient enrollment or other reasons, it would be required to expend significant additional financial resources and time on the completion of clinical development. Tvardi may never obtain regulatory approval for any of its product candidates, and, even if Tvardi does, drug commercialization takes several years and millions of dollars in development costs. General and Administrative Expenses General and administrative expenses consist primarily of personnel costs, including salaries, benefits and stock-based compensation, for personnel in Tvardi’s executive, finance, corporate and business development and administrative functions. General and administrative expenses also include outside professional services, such as legal, audit and accounting services, insurance costs and facility-related expenses, which includes direct depreciation costs and allocated expenses for rent and