Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 148

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 148
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 time to time; |

| ● | the cost of manufacturing its product candidates, which may vary depending on the difficulty of manufacturing, quantity of production and the terms of its agreements with manufacturers; |

| ● | Tvardi’s ability to attract, hire and retain qualified personnel; |

| ● | expenditures that Tvardi will or may incur to develop additional product candidates; |

| ● | the level of demand for its product candidates 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 Tvardi’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 Tvardi’s quarterly and annual operating results. As a result, comparing Tvardi’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 Tvardi’s revenue or operating results fall below the expectations of analysts or investors or below any forecasts Tvardi may provide to the market, or if the forecasts Tvardi provides to the market are below the expectations of analysts or investors, the

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price of its common stock could decline substantially. Such a stock price decline could occur even when Tvardi has met any previously publicly stated guidance it may provide. Risks Related to Research and Development and the Biopharmaceutical Industry Tvardi’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 Tvardi’s product candidates will require significant additional preclinical and clinical development before Tvardi may be able to seek regulatory approval for and launch a product commercially. Tvardi 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. Tvardi is early in its development