Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 20

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 20
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 should they receive approval, which may vary significantly; |

| ● | the risk/benefit profile, cost and reimbursement policies with respect to its product candidates, if approved; |

| ● | existing and potential future therapeutics that compete with its product candidates; |

| ● | changes in the competitive landscape of the Company’s industry, including consolidation among competitors or partners; |

| ● | general market conditions or extraordinary external events, such as recessions or the effects of health epidemics; |

| ● | the changing and volatile U.S. and global economic and political environments; and |

| ● | future accounting pronouncements or changes in its accounting policies. |

The cumulative effects of these factors could result in large fluctuations and unpredictability in the Company’s quarterly and annual operating results. As a result, comparing the Company’s operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in it failing to meet the expectations of industry or financial analysts or investors for any period. If the Company’s revenue or operating results fall below the expectations of analysts or investors or below any forecasts the Company may provide to the market, or if the forecasts the Company provides to the market are below the expectations of analysts or investors, the price of its common stock could decline substantially. Such a stock price decline could occur even when the Company has met any previously publicly stated guidance it may provide. Risks Related to Research and Development and the Biopharmaceutical Industry The Company’s business is highly dependent on the success of its product candidates, TTI-101 and any other product candidates that it advances into the clinic. All of the Company’s product candidates will require significant additional preclinical and clinical development before the Company may be able to seek regulatory approval for and launch a product commercially. The Company is currently conducting Phase 2 clinical trials of TTI-101 in IPF and HCC, has no products that are approved for commercial sale and may never be able to develop marketable products. The Company is early in its development efforts and has only

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one product candidate, TTI-101, in early clinical development and one product candidate, TTI-109, in preclinical development. If TTI-101, TTI-109 or any of its other product candidates encounter safety or efficacy problems, development delays, regulatory issues or other problems, the Company’s development plans and business would be significantly harmed. Before the Company can generate any revenue from sales of its product candidates, TTI-101, TTI-109 or