Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 84

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 84
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| ● | Tvardi’s ability to complete IND application-enabling studies and successfully submit INDs or comparable applications to allow it to initiate clinical trials for current or any future product candidates; |

| ● | whether Tvardi is required by the FDA or similar foreign regulatory authorities to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of its product candidates or any future product candidates; |

| ● | Tvardi’s ability to demonstrate to the satisfaction of the FDA or similar foreign regulatory authorities the safety, potency, purity and acceptable risk-to-benefit profile of its product candidates or any future product candidates; |

| ● | the prevalence, duration and severity of potential side effects or other safety issues experienced with its product candidates or future product candidates; |

| ● | the timely receipt of necessary marketing approvals from the FDA or similar foreign regulatory authorities; |

| ● | the willingness of physicians, operators of clinics and patients to utilize or adopt any of Tvardi’s product candidates or future product candidates as potential cancer treatments; |

| ● | Tvardi’s ability and the ability of third parties with whom it contracts to manufacture adequate clinical and commercial supplies of its product candidates or any future product candidates, remain in good standing with regulatory authorities and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices (cGMPs); |

| ● | Tvardi’s ability to successfully develop a commercial strategy and thereafter commercialize its product candidates or any future product candidates in the United States and internationally, if licensed for marketing, reimbursement, sale and distribution in such countries and territories, whether alone or in collaboration with others; and |

| ● | Tvardi’s ability to establish and enforce intellectual property rights in and to its product candidates or any future product candidates. |

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To become and remain profitable, Tvardi must develop
and eventually commercialize products with significant market potential. This will require it to be successful in a range of challenging
activities, including completing preclinical studies and clinical trials, obtaining marketing approval for product candidates, manufacturing,
marketing and selling products for which it may obtain marketing approval and satisfying any post-marketing requirements. Tvardi may never
succeed in any or all of these activities and, even if it does, it may never generate revenue that is significant enough to achieve profitability.
If Tvardi does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. Tvardi’s
failure to become and remain