Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 600

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 600
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 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 it 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, its other product candidates and any future product candidates, if approved;

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

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

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establishes a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which Tvardi may obtain marketing approval and intend to commercialize on its own or jointly with third parties;

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maintains, expands and protects its intellectual property portfolio;

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invests in or in-licenses other technologies or product candidates;

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continues to build out its organization to engage in such activities; and

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

Given Tvardi’s stage of development, to date it has not had any products approved for sale and has not generated any revenue. Tvardi does not expect to generate any revenues from product sales unless and until it successfully completes development and obtains regulatory approval for one or more of its product candidates, which may not be for several years, if ever. If Tvardi obtains regulatory approval for any of its product candidates, it expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that Tvardi can generate substantial product revenue, it expects to finance its cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. However, Tvardi may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. If Tvardi does raise additional capital through public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences