Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 467

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 467
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 need for a disease-modifying and well-tolerated oral agent to effectively treat IPF, a chronic, debilitating fibrotic lung disease with median survival time of less than five years from time of diagnosis. Tvardi’s lead product candidate, TTI-101, has demonstrated downregulation of biomarkers of fibrosis across multiple preclinical models, supportive of STAT3 inhibition. In particular, in an established functional model of IPF, Tvardi observed dose-dependent, therapeutic reduction in fibrosis and improved lung function. Additionally, the robust PK, PD and safety data Tvardi has generated in oncology to date has allowed Tvardi to rapidly progress into a Phase 2 clinical trial in IPF. In August 2023, Tvardi dosed the first patient in its 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. Tvardi expects to report unblinded data from this clinical trial in the second half of 2025. Based on results from this Phase 2 clinical trial in IPF, it intends to further explore TTI-101 for use as monotherapy or in addition to SoC, nintedanib.

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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**

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95% of patients with HCC have pY-STAT3 in their tumors, which correlates with a worse prognosis. Tvardi has prioritized HCC for its initial development within oncology and believes its 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), Tvardi’s Phase 1 clinical trial data demonstrated a disease control rate of 53%, as measured by RECIST v1.1