Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 529

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 529
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entech), lenvatinib (Lenvima, marketed by Eisai R&D Management Co., Ltd.), durvalumab in combination with tremelimumab (Imfinzi and Imjudo, respectively, marketed by AstraZeneca), regorafenib (Stivarga, marketed by Bayer HealthCare Pharmaceuticals), ramucirumab (Cyramza, marketed by Eli Lilly and Company), cabozantinib (Cabometyx, marketed by Exelixis Inc.), pembrolizumab (Keytruda, marketed by Merck & Co., Inc.), and nivolumab in combination with ipilimumab (Opdivo and Yervoy, marketed by Bristol-Myers Squibb Company). Companies currently developing product candidates in HCC include, but are not limited to, AstraZeneca, Beigene, Bristol Myers Squibb, Elevar Therapeutics, Eli Lilly, Immune-Onc, Iterion Therapeutics, Omega Therapeutics and Tempest Therapeutics. Based on Tvardi’s review of published research, the current SoC in second-line patients with HCC is estimated to have an ORR of ≤ 5%.

The availability of reimbursement from government and other third-party payors will also significantly affect the pricing and competitiveness of Tvardi’s product candidates, if approved for marketing. Tvardi’s competitors also may obtain FDA or other regulatory approval for their products more rapidly than it does, which could result in its competitors establishing a strong market position before Tvardi is able to enter the market.

#### Employees and Human Capital Resources
As of September 30, 2024, Tvardi had 12 full-time employees, 10 of whom are involved in research and development activities. Five of Tvardi’s employees hold Ph.D. or M.D. degrees. None of its employees are subject to a collective bargaining agreement. Tvardi considers its relationship with its employees to be good.

Tvardi recognizes that its continued ability to attract, retain and motivate exceptional employees is vital to ensuring its long-term competitive advantage. Tvardi’s employees are critical to its long-term success and are essential to helping Tvardi meet its goals. Among other things, it supports and incentivizes its employees in the following ways:

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Talent development, compensation and retention: Tvardi’s human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating its existing and additional employees. The principal purposes of