Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 13

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 13
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2 clinical trials for idiopathic pulmonary fibrosis (“IPF”), and hepatocellular carcinoma (“HCC”). The Company has no products approved for commercial sale and has not generated any revenue to date. The Company has incurred significant net losses since its inception and has financed operations principally through equity and debt financing. The Company continues to incur significant research and development and other expenses related to its ongoing operations. Legacy Tvardi’s net loss was $9.6 million

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and $4.2 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, it had an accumulated deficit of $101.8 million. The Company has devoted substantially all of its resources and efforts to research and development, and expects that it will be several years, if ever, before the Company has a commercialized product candidate and generates revenue from sales. Even if the Company receives marketing approval for and commercializes one or more of its product candidates, the Company expects that it will continue to incur substantial research and development and other expenses in order to further develop and, if approved, market additional potential product candidates. The Company expects to continue to incur significant losses for the foreseeable future, and anticipates that its expenses will increase substantially if, and as, it:

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

| ● | discovers and develops additional product candidates; |

| ● | advances its preclinical development programs into clinical development; |

| ● | experiences delays or interruptions to preclinical studies, clinical trials, receipt of services from its third-party service providers on whom the Company relies or its supply chain; |

| ● | seeks and maintains regulatory approvals for any product candidates that successfully complete clinical trials; |

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

| ● | increases the amount of research and development activities to identify and develop product candidates; |

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

| ● | expands its operational, financial and management systems and increases personnel, including personnel to support its clinical development and manufacturing efforts and operations as a public company; |

| ● | establishes a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which it may obtain marketing approval and intends to commercialize on its own or jointly