Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 167

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 167
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 further develop and commercialize TTI-101, TTI-109 or any other product candidates and, accordingly, may not achieve
its research, development and commercialization goals.

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The Company may acquire additional technology and
complementary businesses in the future. Acquisitions involve many risks, any of which could materially harm its business, including the
diversion of management’s attention from core business concerns, failure to effectively exploit acquired technologies, failure to
successfully integrate the acquired business or realize expected synergies or the loss of key employees from either its business or the
acquired businesses.

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Tvardi currently has no marketing and sales organization and has no experience as a company in commercializing products, and Tvardi may have to invest significant resources to develop these capabilities. If Tvardi is unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell its products, Tvardi may not be able to generate product revenue.

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Tvardi has no internal sales, marketing or distribution
capabilities, nor has it commercialized a product. If any of Tvardi’s product candidates ultimately receives regulatory approval,
Tvardi expects to establish a marketing and sales organization with technical expertise and supporting distribution capabilities to commercialize
each such product in major markets, which will be expensive and time consuming. Tvardi has no prior experience as a company in the marketing,
sale and distribution of pharmaceutical products, and there are significant risks involved in building and managing a sales organization,
including its ability to hire, retain and incentivize qualified individuals, generate sufficient sales leads, provide adequate training
to sales and marketing personnel and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the
development of Tvardi’s internal sales, marketing and distribution capabilities would adversely impact the commercialization of
these products. Tvardi may also choose to collaborate with third parties that have direct sales forces and established distribution systems,
either to augment its own sales force and distribution systems or in lieu of its own sales force and distribution systems. Tvardi may
not be able to enter into collaborations or hire consultants or external service providers to assist Tvardi in sales, marketing and distribution
functions on acceptable financial terms, or at all. In addition, its product revenues and its profitability, if any, may be lower if it
relies on third parties for these functions than if it were to market, sell and distribute any products that it develops itself. Tvardi
likely will have little control over such