Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 95

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 95
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/day, 800 mg/day and placebo arms of
the clinical trial.

​

Separately, early safety data from the combination
arms (TTI-101 + pembrolizumab or TTI-101 + atezolizumab + bevacizumab) of the Phase 1b/2 clinical trial in HCC revealed a higher-than-expected
incidence of pulmonary-related treatment-emergent adverse events, which are known side effects of treatment with standard of care. Based
upon this information, and after consultations with thought leaders and investigators, the protocol was modified to explore lower dosages
and intermittent schedules of TTI-101 in combination with pembrolizumab or atezolizumab + bevacizumab.

​

Clinical trials of Tvardi’s product candidates
must be conducted in carefully defined subsets of patients who have agreed to enter into clinical trials. Consequently, it is possible
that Tvardi’s clinical trials, or those of any potential future collaborator, may indicate an apparent positive effect of a product
candidate that is greater than the actual positive effect, if any, or alternatively fail to identify undesirable side effects. If one
or more of Tvardi’s product candidates receives marketing approval and Tvardi, or others, discover that it is less effective than
previously believed or causes undesirable side effects that were not previously identified, including during any long-term follow-up observation
period recommended or required for patients who receive treatment using Tvardi’s products, a number of potentially significant negative
consequences could result, including:

​

| ● | regulatory authorities may withdraw approvals of such product, seize the product or seek an injunction against its manufacture or distribution; |

| ● | Tvardi, or any future collaborators, may be required to recall the product, change the way such product is administered to patients or conduct additional clinical trials; |

| ● | additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product; |

| ● | regulatory authorities may require additional warnings on the label, such as a “black box” warning or a contraindication, or impose distribution or use restrictions; |

| ● | Tvardi, or any future collaborators, may be required to create a Risk Evaluation and Mitigation Strategy (REMS), which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use; |

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