Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 98

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 98
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 as long-term toxicology studies or impose other requirements before permitting it to initiate a clinical trial. |

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Tvardi’s product development costs will increase
if it experiences additional delays in clinical testing or in obtaining marketing approvals. Tvardi does not know whether any of its clinical
trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. If Tvardi does not achieve product
development goals in the timeframes it announces and expects, the approval and commercialization of its product candidates may be delayed
or prevented entirely. Significant clinical trial delays also could shorten any periods during which it may have the exclusive right to
commercialize product candidates and may allow competitors to bring products to market before Tvardi does, potentially impairing its ability
to successfully commercialize product candidates and harming its business and results of operations. Any delays in Tvardi’s clinical
development programs may harm its business, financial condition and results of operations significantly

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Interim, blinded and preliminary data from Tvardi’s clinical trials that it announces or publishes from time to time may change as more patient data become available or as additional analyses are conducted and as the data are subject to audit and verification procedures that could result in material changes in the final data.

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From time to time, Tvardi may publish interim, blinded
or preliminary data from clinical trials. Interim data from clinical trials that it may complete are subject to the risk that one or more
of the clinical outcomes may materially change as patient enrollment continues and more or longer-term patient data become available.
For example, Tvardi previously reported the preliminary, blinded safety data review of 45 patients in its Phase 2 clinical trial in patients
suffering from IPF, which represented a small sample size relative to Tvardi’s enrollment for the overall clinical trial. The purpose
of this blinded data review was to enable an assessment of the overall management and conduct of the clinical trial, without unblinding
any individual patient data. Tvardi reported preliminary data from this trial 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. Preliminary data also remain
subject to audit and verification procedures that may result in the final data being materially different from the preliminary data previously
published. As a result, interim and preliminary blinded data should be viewed with caution until the final data are available, as initial
clinical trial