Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 577

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 577
---
 29,443 | ​ | ​ | ​ | ​        | ​ | (1)%  | ​ | ​ | ​ | ​    | ​ | 29,637 | ​ | ​ | ​ | ​        | ​ | (23)% | ​ | ​ |
| Total R&D expense                                 | ​ | ​ | ​                           | $ | 108,510 | ​ | ​ | ​ | ​        | ​ | 18%   | ​ | ​ | ​ | ​    | $ | 91,879 | ​ | ​ | ​ | ​        | ​ | 11%   | ​ | ​ |

For the year ended December 31, 2023 compared to the year ended December 31, 2022, the $18.8 million increase in direct clinical trial costs was primarily due to the increases in clinical trial spend related to our three late-stage oral difelikefalin programs in 2023. These increases were partially offset by decreases related to the Phase 2 efficacy trial for chronic pruritus associated with NP, costs associated with supportive Phase 1 oral studies, and other general costs associated with our oral programs. In December 2023, we announced that we discontinued the atopic dermatitis program due to clinical trial results and in January 2024, we announced the discontinuation of the advanced chronic kidney disease program to focus on NP only. The decrease in stock compensation expense is primarily related to lower grant date fair values for new option grants during the year ended December 31, 2023, and lower stock compensation expense related to time-based restricted stock units that vested in February 2023. Other R&D operating expenses for the year ended December 31, 2023 included $1.7 million related to the agreement with Patheon for forecasted manufacturing commitments that are no longer needed due to the reduced demand expectations of KORSUVA in the United States, as well as increased payroll-related costs as compared to the prior period. Other R&D operating expenses for the year ended December 31, 2022 included the recognition of the $5.0 million milestone payment due to Enteris. The following table summarizes our R&D expenses by product candidate for the years ended December 31, 2023 and 2022:

| ​                                                                 
 ​                                                                 | ​ 
 ​ | ​ 
 ​ | Year Ended December 31,     
 2023                        |   |         |   |   |   |          | ​ | ​ | 2022 |