Company: TVRD
Filing Date: 2025-10-20
Form Type: S-1/A
Source: 0001104659-25-100896
Chunk: 12

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-20
Form: S-1/A
Chunk 12
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2 clinical trial of TTI-101 in idiopathic pulmonary fibrosis (“IPF”) in October 2025 and concluded that the study did not meet its goals. The Company is conducting additional analyses to further understand these results and inform next steps. 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

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through equity and debt financing. The Company continues to incur significant research and development and other expenses related to its ongoing operations. The Company’s net income was $4.2 million and its net loss was $5.4 million for the three and six months ended June 30, 2025, respectively. Legacy Tvardi’s net loss was $7.0 million and $11.2 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, it had an accumulated deficit of $97.6 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.

Although the Company generated net income for the three months ended June 30, 2025 as a result of the net changes in the fair value of its Convertible Notes, 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:

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

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discovers and develops additional product candidates;

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advances its preclinical development programs into clinical development;

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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;

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

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

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increases the amount of research