Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 108

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 108
---
 Tvardi’s competitors
also may obtain FDA or other regulatory approval for their products more rapidly than Tvardi may obtain approval for its product candidates,
which could result in Tvardi’s competitors establishing a strong market position before Tvardi is able to enter the market. Additionally,
products or technologies developed by Tvardi’s competitors may render its potential product candidates uneconomical or obsolete,
and Tvardi may not be successful in marketing any product candidates it may develop against competitors. The availability of competitive
products could limit the demand, and the price Tvardi is able to charge, for any products that it may develop and commercialize.

​

Compliance with governmental regulations regarding the treatment of animals used in research could increase Tvardi’s operating costs, which would adversely affect the commercialization of its products.

​

The Animal Welfare Act (AWA), is the federal law
that covers the treatment of certain animals used in research. Currently, the AWA imposes a wide variety of specific regulations that
govern the humane handling, care, treatment and transportation of certain animals by producers and users of research animals, most notably
relating to personnel, facilities, sanitation, cage size and feeding, watering and shipping conditions. Third parties with whom Tvardi
contracts are subject to registration, inspections and reporting requirements under the AWA. Furthermore, some states have their own regulations,
including general anti-cruelty legislation, which establish certain standards in handling animals. Comparable rules, regulations and/or
obligations exist in many foreign jurisdictions. If Tvardi or its contractors fail to comply with regulations concerning the treatment
of animals used in research, Tvardi may be subject to fines and penalties and adverse publicity, and its operations could be adversely
affected.

​

If product liability lawsuits are brought against Tvardi, it may incur substantial financial or other liabilities and may be required to limit commercialization of its product candidates.

​

Tvardi faces an inherent risk of product liability
as a result of testing TTI-101, TTI-109 and any of its other product candidates in clinical trials and will face an even greater risk
if it commercializes any products. For example, Tvardi may be sued if its product candidates cause, or are perceived to cause, injury
or are found to be otherwise unsuitable during clinical trials, manufacturing, marketing or sale. Any such product liability claims may
include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product