Company: TVRD
Filing Date: 2025-10-20
Form Type: S-1/A
Source: 0001104659-25-100896
Chunk: 185

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-20
Form: S-1/A
Chunk 185
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 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. Preliminary Summary of Change from Baseline in FVC (mL) at 12 Weeks While on Treatment

| ​                | ​ | ​ |       Placebo | ​ | ​ | TTI-101 – 400mg | ​ | ​ | TTI-101 – 800mg | ​ |
| n                | ​ | ​ |            24 | ​ | ​ |               8 | ​ | ​ |              13 | ​ |
| Mean in mL (SD2) | ​ | ​ | -22.2 (126.0) | ​ | ​ |   -61.1 (190.7) | ​ | ​ |  -102.8 (238.3) | ​ |

REVERT IPF Phase 2 Clinical Trial of TTI-101 Evaluating Safety, PK, Biomarkers and Preliminary Efficacy including FVC in Patients suffering from IPF

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TABLE OF CONTENTS

The dosing regimen of this clinical trial was informed by our learnings from our concurrently enrolling Phase 1b/2 clinical trial in HCC, where we explored escalating dosages of TTI-101 up to 1200 mg/day and determined 800 mg/day as the recommended monotherapy Phase 2 dose (“RP2D”). Based upon the HCC RP2D determination as well as other early data, we requested that the Safety Monitoring Committee of the Phase 2 clinical trial in IPF convene to consider discontinuation of enrollment to 1200 mg/day arm. In July 2024, an independent safety monitoring committee (“SMC”), after reviewing unblinded data, agreed with our recommendation to discontinue enrollment to the 1200 mg/day arm. In addition, the SMC conducted an unblinded risk-benefit analysis of the remaining arms of the clinical trial, and recommended that we continue enrolling to the 400 mg/day, 800 mg/day and placebo arms of the clinical trial.

Blinded, Preliminary Interim Data from Phase 2 Clinical Trial

On September 30, 2024, the SMC completed a follow-up unblinded assessment of AEs, discontinuations, and pulmonary function test data and noted that it did