Company: TVRD
Filing Date: 2025-10-20
Form Type: S-1/A
Source: 0001104659-25-100896
Chunk: 191

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-20
Form: S-1/A
Chunk 191
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 treatment), with a median decrease of 55% in pY-STAT3 levels. Among the three patients who demonstrated a clinical benefit, the median decrease was 79% in pY-STAT3 levels. The biologic effect of TTI-101 monotherapy in patients with advanced diseases, who had previously been treated with a median of over three prior systemic therapies and evaluable for tumor response is outlined in the table below. Overall, 41 patients were evaluable for response, and we observed a disease control rate of 54%, as measured by RECIST v1.1, among all tumor types, including confirmed partial responses in HCC, ovarian and gastric tumor types. Among the 17 patients with HCC, we observed a disease control rate of 53%, as measured by RECIST v1.1.

| ​                             | ​ | ​ | Patients with HCC(N=17) n (%) | ​ | ​ | All Patients withAdvanced Solid Tumors(N=41) n (%) | ​ |
| Confirmed partial response(1) | ​ | ​ |                        3 (18) | ​ | ​ |                                            5 (12)* | ​ |
| Stable disease(2)             | ​ | ​ |                        6 (35) | ​ | ​ |                                            17 (41) | ​ |
| Progressive disease(3)        | ​ | ​ |                        8 (47) | ​ | ​ |                                            19 (46) | ​ |
| Disease Control Rate(4)       | ​ | ​ |                           53% | ​ | ​ |                                                54% | ​ |
| Median Number of Therapies    | ​ | ​ |                             2 | ​ | ​ |                                                3.5 | ​ |

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TABLE OF CONTENTS

Evaluable patients included patients with a follow-up on-study tumor assessment at least 42 days following cycle 1, day 1. *Two non-HCC patients demonstrated a confirmed partial response: one had ovarian cancer, the second had gastric cancer.

(1)

Confirmed partial response (“cPR”), means at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

(2)

Stable disease means neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

(3)

Progressive disease means at least a 20% increase in the sum of diam