Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 163

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 163
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 fibrosis and improved lung function. Additionally, the robust PK, PD and safety data we have generated in oncology to date has allowed us to rapidly progress into a Phase 2 clinical trial in IPF. In August 2023, we dosed the first patient in our ongoing 12-week REVERT IPF Phase 2 clinical trial for the treatment of patients suffering from IPF. Preliminary blinded data from the two dose levels of TTI-101 and placebo in 38 patients (randomized 1:1:1) to date indicated approximately 50% of participants reporting FVC values near or above baseline. The natural course of disease for patients suffering from IPF, regardless of SoC therapies, is a decline in lung function. We expect to report unblinded data from this clinical trial in the fourth quarter of 2025. Based on results from this Phase 2 clinical trial in IPF, we intend to further explore TTI-101 for use as monotherapy or in addition to SoC, nintedanib. |

| ● | Progress TTI-101 through pivotal development for the treatment of fibrosis-driven cancers, with initial development in HCC. As in IPF, STAT3 serves an integral role in the cellular processes that drive aberrant proliferation, survival, ECM deposition and immune suppression in HCC. Greater than 95% of patients with HCC have pY-STAT3 in their tumors, which correlates with a worse prognosis. We have prioritized HCC for our initial development within oncology and believe our results to date support TTI-101’s differentiated mechanism of action to deliver therapeutic benefit as monotherapy and in combination with existing approved agents, if approved. Amongst patients with HCC (n=17), our Phase 1 clinical trial data demonstrated a disease control rate of 53%, as measured by RECIST v1.1, after a median of two prior systemic therapies. We are currently conducting our REVERT LIVER CANCER Phase 1b/2 clinical trial for TTI-101 in HCC both as monotherapy and in combination with pembrolizumab or atezolizumab + bevacizumab and expect to report preliminary topline data in the first half of 2026. Based on results from this Phase 2 clinical trial in HCC, we intend to further explore TTI-101 for use as monotherapy or in combination with existing SoC. |

| ● | Expand our pipeline into additional indications where