Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 127

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 127
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 | discover and develop additional product candidates; |

| ● | advance our preclinical development programs into clinical development; |

| ● | experience delays or interruptions to preclinical studies, clinical trials, receipt of services from our third-party service providers on whom we rely, or our supply chain; |

| ● | seek and maintain regulatory approvals for any product candidates that successfully complete clinical trials; |

| ● | commercialize TTI-101, TTI-109, our other product candidates and any future product candidates, if approved; |

| ● | hire additional clinical development, quality control, scientific and management personnel; |

| ● | expand our operational, financial and management systems and increase personnel, including personnel to support our clinical development and manufacturing efforts and operations as a public company; |

| ● | establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which we may obtain marketing approval and intend to commercialize on our own or jointly with third parties; |

| ● | maintain, expand and protect our intellectual property portfolio; |

| ● | invest in or in-license other technologies or product candidates; |

| ● | continue to build out our organization to engage in such activities; and |

| ● | incur additional legal, accounting, investor relations and other general and administrative expenses associated with operating as a public company. |

Given our stage of development, to date we have not had any products approved for sale and have not generated any revenue. We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which may not be for several years, if ever. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses

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or similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants or other restrictions limiting our ability