Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 134

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 134
---
 include:

| ● | expenses incurred under agreements with consultants and third-party contract research organizations (“CROs”) that conduct research and development activities on our behalf; |

| ● | costs related to production of preclinical and clinical materials, including fees paid to contract manufacturers; and |

| ● | costs associated with license agreements. |

Indirect costs include:

| ● | personnel costs, which includes salaries, benefits, stock-based compensation expense and travel expenses, for personnel engaged in research and development functions; |

| ● | facilities, amortization and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and |

| ● | costs related to compliance with quality and regulatory requirements. |

Pursuant to U.S. GAAP and our internal policies, including our clinical trial accrual policy, we expense all research and development costs in the periods in which they are incurred, including the costs of treatment center start-up activities, patient enrollment, and study reporting. Costs for certain other research and development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors and third-party service providers. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our audited financial statements and unaudited condensed consolidated financial statements as prepaid or accrued research and development expenses. The majority of our clinical spending in the three and six months ended June 30, 2025 and 2024 and in the years ended December 31, 2024 and 2023 was on TTI-101, for which certain direct research and development costs are tracked by clinical trial. Spending for the development of TTI-109 primarily began in 2023. All costs incurred for TTI-109 for the three and six months ended June 30, 2025 and 2024 are related to chemistry, manufacturing and control (“CMC”) costs as well as pre-clinical costs. Costs incurred for TTI-109 for the years ended December 31, 2024 and 2023 are related to CMC and pre-clinical costs. We expect our research and development expenses to increase substantially for the foreseeable future as we continue to invest in the development of TTI-101 and TTI-109, support our ongoing preclinical programs and discover any new product candidates, as well as increase our headcount. In particular, clinical development, as opposed to pre