Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 81

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 81
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holders may not be able to resell their shares of common stock for a profit, if at all. |

| ● | Future sales of shares by existing stockholders could cause Tvardi’s stock price to decline. |

| ● | If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about Tvardi, its business or its market, its stock price and trading volume could decline. |

Risks Related to Tvardi’s Financial Position and Need for Additional Capital

Tvardi has incurred significant net losses since inception, and Tvardi expects to continue to incur significant net losses for the foreseeable future.

Development of biopharmaceutical product candidates
is a highly speculative undertaking and involves a substantial degree of risk. Tvardi is still in the early stages of development of its
product candidates and its lead product candidate, TTI-101, is only in a Phase 2 clinical trial for hepatocellular carcinoma (HCC). Tvardi
reported preliminary data from its Phase 2 clinical trial of TTI-101 in IPF in October 2025 and concluded that the study did not meet
its goals. Tvardi is conducting additional analyses to further understand these results and inform next steps. Tvardi has no products
approved for commercial sale and has not generated any revenue to date. Tvardi has incurred significant net losses since its inception
and has financed operations principally through equity and debt financing. Tvardi continues to incur significant research and development
and other expenses related to its ongoing operations. Tvardi’s net losses were $5.5 million and $10.9 million for the three and
nine months ended September 30, 2025, respectively. As of September 30, 2025, Tvardi had an accumulated deficit of $103.2 million. Tvardi
has devoted substantially all of its resources and efforts to research and development, and expects that it will be several years, if
ever, before Tvardi has a commercialized product candidate and generates revenue from sales. Even if Tvardi receives marketing approval
for and commercializes one or more of its product candidates, Tvardi expects that it will continue to incur substantial research and development
and other expenses in order to further develop and, if approved, market additional potential product candidates.

Tvardi expects to continue to incur significant
losses for the foreseeable future, and anticipates that its expenses will increase substantially if, and as, it: