Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 144

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 144
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 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. |

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 profitable would decrease the value of the company and could impair its ability to raise capital, maintain research and development efforts, expand its business or continue its operations. Tvardi’s financial condition raises substantial doubt as to its ability to continue as a going concern. As of September 30, 2024, Tvardi had approximately $9.4 million in cash and cash equivalents and an accumulated deficit of $79.5 million, and Tvardi has incurred and expects to continue to incur significant costs in developing its product candidates. In light of certain factors, including that Tvardi has suffered recurring losses from operations and has an accumulated deficit of $79.5 million, there is substantial doubt as to its ability to continue as a going concern. To date, Tvardi has not generated product revenues from its activities and has incurred substantial operating losses. Tvardi expects that it will continue to generate substantial operating losses for the foreseeable future until it completes development and approval of its