Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 45

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 45
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uable patients with at
least one baseline and on-treatment FVC measurement was placebo (n=29), 400mg (n=23), and 800mg (n=27). The numbers, however, declined
by the 12-week timepoint to placebo (n=24), 400mg (n=8), or 800mg (n=13). The preliminary analysis was performed on actual FVC values;
values were not modeled or imputed.

​

Preliminary analysis of exploratory efficacy showed
no statistically significant differences between placebo and treatment arms; though, the study was not powered to evaluate exploratory
endpoints. Overall, from baseline to

<div align='center'>27</div>

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last visit on treatment, the proportion of patients who demonstrated
FVC improvement from baseline was 41% for the placebo, and 39% and 44% for the 400mg and 800mg arms, respectively.

​

FVC change from baseline overlapped between treatment
arms, with large variability within each cohort. Notably, the placebo-treated patients’ FVC decline was lower than expected compared
to historical controls.

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<div align='center'>Preliminary Summary of Change from Baseline in FVC (mL) at 12 Weeks While on Treatment</div>

| ​                               |       Placebo | TTI-101 – 400mg | TTI-101 – 800mg | ​ |
| n                               |            24 |               8 |              13 | ​ |
| Mean in mL (standard deviation) | -22.2 (126.0) |   -61.1 (190.7) |  -102.8 (238.3) | ​ |

​

We believe the IPF patient population is less tolerant
to gastrointestinal treatment emergent adverse events (TEAEs) than the oncology patient population. We previously reported gastrointestinal
TEAEs from our TTI-101 trials in oncology. As of August 2024, we observed similar incidence and grade in both the Phase 1 oncology study
and the ongoing Phase 2 HCC study with diarrhea being the most commonly reported TEAE, mostly grade 1 or 2.

The incidence of discontinuations due to gastrointestinal
events was unexpectedly higher in the IPF study than previously observed in the oncology studies with TTI-101, at similar doses. The overall
discontinuation rate in the IPF