Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 34

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 34
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ure by the FDA. Although the Company received Fast Track designation for TTI-101, it may not experience a faster development process, review or licensure compared to conventional FDA procedures or pathways, and receiving a Fast Track designation does not provide assurance of ultimate FDA licensure. In addition, the FDA may withdraw any Fast Track designation granted to the Company if it believes that the designation is no longer supported by data from the Company’s clinical development program. The FDA may also withdraw any Fast Track designation at any time.

Even if a product candidate the Company develops receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Even if TTI-101, TTI-109 or any other product candidate the Company develops receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, such as Medicare and Medicaid programs and managed care organizations, and others in the medical community. In addition, the availability of coverage by third-party payors may be affected by existing and future healthcare reform measures designed to reduce the cost of health care. If the product candidates the Company develops do not achieve an adequate level of acceptance, the Company may not generate significant product revenues and the Company may not become profitable.

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The degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including:

| ● | efficacy and potential advantages compared to alternative treatments; |

| ● | the ability to offer the Company’s products, if approved, for sale at competitive prices; |

| ● | convenience and ease of administration compared to alternative treatments; |

| ● | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |

| ● | the recommendations with respect to the Company’s product candidates in guidelines published by various scientific organizations applicable to the Company and its product candidates; |

| ● | the strength of marketing and distribution support; |

| ● | the ability to obtain sufficient third-party coverage and adequate reimbursement; and |

| ● | the prevalence and severity of any side effects. |

If government and other third-party payors do not provide coverage and adequate reimbursement levels for any products the Company commercializes, market acceptance and commercial success would be reduced. The Company faces substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than the Company. The development and commercialization of