Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 69

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 69
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 significant estimates in regard
to the timing and accounting for these expenses. Tvardi estimates costs of research and development activities conducted by service providers,
which include costs to properly initiate and manage ongoing preclinical studies and clinical trials. The diverse nature of services being
provided under contracts with Tvardi’s CROs, CDMOs and other arrangements, the different compensation arrangements that exist for
each type of service and the lack of timely information related to certain pre-clinical and clinical activities complicates the estimation
of accruals for services rendered by the CROs, CDMOs and other vendors in connection with preclinical studies and clinical trials.

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Examples of estimated accrued research and development
expenses include:

| ● | expenses incurred under agreements with third parties, including Tvardi’s CROs that conducts research, preclinical studies and clinical trials on its behalf; |

| ● | expenses incurred under agreements with third parties, including its CDMOs, that develop and manufacture its product candidate for use in Tvardi’s preclinical studies and clinical trials; and |

| ● | other providers and vendors in connection with research and development activities. |

Tvardi bases its expenses related to preclinical
studies and clinical trials on its estimates of the services received and efforts expended pursuant to quotes and contracts with its CROs,
CDMOs and other third-party vendors that conduct research, preclinical studies and clinical trials on its behalf. The financial terms
of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances
in which payments made to Tvardi’s vendors will exceed the level of services provided and result in a prepayment of the expense.

Payments under some of these contracts depend on
factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing fees, Tvardi estimates
the time period over which services will be performed, the enrollment of patients and the level of effort to be expended in each period.
If the actual timing of the performance of services or the level of effort varies from Tvardi’s estimate, or if Tvardi receives
any change orders from its third-party providers, it adjusts the accrual or amount of prepaid expense accordingly. Although Tvardi does
not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services
performed relative to the actual status and