Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 52

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 52
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 months ended September 30, 2025 and 2024. No royalty fees have been incurred to date.

Components of Operating Results

Revenue

Legacy Tvardi has not generated any revenue since
its inception and Tvardi does not expect to generate any revenue from the sale of products in the near future, if at all. If Tvardi’s
development efforts for TTI-101, TTI-109 or additional product candidates that it may develop in the future are successful and result
in marketing approval, or if Tvardi enters into collaboration or license agreements with third parties, it may generate revenue in the
future from a combination of product sales or payments from such collaboration or license agreements.

Operating Expenses

Legacy Tvardi’s operating expenses since inception
have consisted primarily of research and development expenses and general and administrative costs.

Research and Development Expenses

Tvardi’s research and development expenses
consist primarily of direct and indirect costs incurred in performing clinical and preclinical development activities.

Direct costs include:

| ● | expenses incurred under agreements with consultants and third-party contract research organizations (CROs) that conduct research and development activities on Tvardi’s behalf; |

| ● | costs related to production of preclinical and clinical materials, including fees paid to contract manufacturers; and |

| ● | costs associated with license agreements. |

Indirect costs include:

| ● | personnel costs, which includes salaries, benefits, stock-based compensation expense and travel expenses, for personnel engaged in research and development functions; |

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Table of Contents

| ● | facilities, amortization and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and |

| ● | costs related to compliance with quality and regulatory requirements. |

Pursuant to U.S. GAAP and Tvardi’s internal
policies, including its clinical trial accrual policy, Tvardi expenses all research and development costs in the periods in which they
are incurred, including the costs of treatment center start-up activities, patient enrollment, and study reporting. Costs for certain
other research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using
information and data provided to Tvardi by its vendors and third-party service providers. Payments for these activities are based on the
terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in Tvardi’s unaudited
condensed consolidated