Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 42

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 42
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 “— Liquidity and Capital Resources” below for further discussion.

Tvardi will require additional funding in order
to finance operations and complete its ongoing and planned clinical trials. Access to such funding on acceptable terms cannot be assured.

Tvardi expects that its expense and capital requirements
will increase substantially in connection with its ongoing activities and for the foreseeable future, particularly if Tvardi, among other
things:

| ● | advances TTI-101, TTI-109 and its other product candidates through clinical development and, if successful, later-stage clinical trials; |

| ● | discovers and develops additional product candidates; |

| ● | advances its preclinical development programs into clinical development; |

| ● | experiences delays or interruptions to preclinical studies, clinical trials, receipt of services from its third-party service providers on whom it relies, or its supply chain; |

| ● | seeks and maintains regulatory approvals for any product candidates that successfully complete clinical trials; |

| ● | commercializes TTI-101, TTI-109, its other product candidates and any future product candidates, if approved; |

| ● | hires additional clinical development, quality control, scientific and management personnel; |

| ● | expands its operational, financial and management systems and increase personnel, including personnel to support its clinical development and manufacturing efforts and operations as a public company; |

| ● | establishes a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which Tvardi may obtain marketing approval and intend to commercialize on its own or jointly with third parties; |

| ● | maintains, expands and protects its intellectual property portfolio; |

| ● | invests in or in-licenses other technologies or product candidates; |

| ● | continues to build out its organization to engage in such activities; and |

| ● | incurs additional legal, accounting, investor relations and other general and administrative expenses associated with operating as a public company. |

Given Tvardi’s stage of development, to date
it has not had any products approved for sale and has not generated any revenue. Tvardi does not expect to generate any revenues from
product sales unless and until it successfully completes development and obtains regulatory approval for one or more of its product candidates,
which may not be for several years, if ever. If Tvardi obtains regulatory approval for any of its product candidates, it expects
to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until
such time, if ever, that T