Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 127

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 127
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 months ended March 31, 2025 (as filed as Exhibit 99.6 to our Form 8-K/A, filed with the SEC on May 13, 2025) and concluded that there are conditions present in the aggregate that raise substantial doubt about our ability to continue as a going concern. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources as of March 31, 2025 sooner than we expect. See the subsection titled “— Liquidity and Capital Resources” below for further discussion. We will require additional funding in order to finance operations and complete our ongoing and planned clinical trials. Access to such funding on acceptable terms cannot be assured. We expect that our expense and capital requirements will increase substantially in connection with our ongoing activities and for the foreseeable future, particularly if we, among other things:

| ● | advance TTI-101, TTI-109 and our other product candidates through clinical development and, if successful, later-stage clinical trials; |

| ● | 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