Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 220

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 220
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 imposed on imports from countries where Tvardi’s suppliers operate;

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greater challenges and increased costs with enforcing and periodically auditing or reviewing Tvardi’s suppliers’ and manufacturers’ compliance with cGMPs or status acceptable to the FDA, EMA or comparable foreign regulatory authorities;

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reduced protection for intellectual property rights, including trademark protection, in some countries;

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disruptions in operations due to global, regional or local public health crises or other emergencies or natural disasters;

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disruptions or delays in shipments; and

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changes in local economic conditions in countries where Tvardi’s manufacturers or suppliers are located.

These and other factors beyond Tvardi’s control could interrupt Tvardi’s suppliers’ production, influence the ability of Tvardi’s suppliers to export its clinical supplies cost-effectively or at all, and inhibit Tvardi’s suppliers’ ability to procure certain materials, any of which could harm its business, financial condition, results of operations and prospects.

Tvardi’s suppliers and any future collaborators may need assurances that its financial resources and stability on a stand-alone basis are sufficient to satisfy their requirements for doing or continuing to do business with Tvardi.

Tvardi’s suppliers and any future collaborators may need assurances that its financial resources and stability on a stand-alone basis are sufficient to satisfy their requirements for doing or continuing to do business with Tvardi. If these parties are not satisfied with its financial resources and stability, it could have a material adverse effect on Tvardi’s ability to develop its drug candidates, enter into licenses or other agreements and on its business, financial condition or results of operations.

### Risks Related to Managing Tvardi’s Business and Operations
Tvardi may encounter difficulties in managing its growth, which could adversely affect its operations.

As of September 30, 2024, Tvardi had 12 full-time employees. As Tvardi’s clinical development and commercialization plans and strategies develop, it will need to expand its managerial, clinical, regulatory, sales, marketing, financial, development, manufacturing and legal capabilities or contract with third parties to provide these capabilities for Tvardi. As Tvardi’s operations expand, Tvardi expects that it will need to manage additional relationships with various strategic collaborators, suppliers and other third parties. Tvardi’s future growth would impose significant added responsibilities on members of management, including:

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identifying, recruiting, integrating, retaining and motivating additional employees;

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managing Tvardi’s development and commercialization efforts effectively, including the