Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 58

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 58
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    604 | ​ |        |    206 |   |    34.1 | % |
| Total research and development expenses              | ​ | $                  | 3,603 | ​ | $    | 4,795 | ​ | $      | -1,192 |   |    -24.9 | % | ​ | $                 | 12,520 | ​ | $    | 15,047 | ​ | $      | -2,527 |   |   -16.8 | % |

​

Research and development
expenses were $3.6 million for the three months ended September 30, 2025, compared to $4.8 million for the three months
ended September 30, 2024. The decrease of $1.2 million was primarily driven by costs associated with Tvardi’s product candidate
TTI-101, including decreases of $1.4 million, $1.0 million and $0.7 million related to Tvardi’s HCC, IPF and metastatic breast cancer
(mBC) trials, respectively. The decrease in Tvardi’s HCC trial was primarily attributable to the changes in patient enrollments
and estimated study costs. The decrease in Tvardi’s IPF trial was attributable to the trial being completed in the second quarter
of 2025, with no additional expenses expected to be incurred until the fourth quarter of 2025. The decrease in Tvardi’s mBC trial
was due to the discontinuation of the trial in January 2024.

The increase of $2.0 million related to Tvardi’s
product candidate TTI-109 was primarily driven by the healthy volunteer study, which began in the third quarter of 2025, as well as related
CMC costs.

Research and development expenses were $12.5 million
for the nine months ended September 30, 2025, compared to $15.0 million for the nine months ended September 30, 2024.
The decrease of $2.5 million was primarily driven by costs associated with Tvardi’s product candidate TTI-101, including decreases
of $3.0 million and $3.0 million related to Tvardi’s HCC and mBC trials, respectively. The decrease in Tvardi’s HCC trial
was attributable to the changes in patient enrollments and estimated study costs, while the decrease in Tvardi’s mBC trial was due