Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 457

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 457
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 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. 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, after a median of two prior systemic therapies. Tvardi is currently conducting its REVERTLIVER CANCER Phase 1b/2 clinical trial for TTI-101 in HCC both as monotherapy and in combination with pembrolizumab or atezolizumab + bevacizumab and expects to report preliminary topline data in the second half of 2025. Based on results from this Phase 2 clinical trial in HCC, Tvardi intends to further explore TTI-101 for use as monotherapy or in combination with existing SoC. |

| ● | Expand Tvardi’s pipeline into additional indications where STAT3 activation plays a central role in disease pathogenesis. Tvardi intends to continue leveraging its deep expertise in STAT3 biology to develop multiple product candidates for a broad range of fibrosis-driven diseases. In addition to its development of TTI-101, Tvardi is advancing TTI-109 through IND- |

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| enabling studies. Tvardi plans to leverage the data from these preclinical studies to determine the optimal path forward for TTI-109, targeting an IND submission in the first half of 2025. |

| ● | Evaluate and pursue tailored strategies to maximize the impact of Tvardi’s product candidates and benefit to patients. Tvardi retains exclusive worldwide rights to all of its product candidates. It intends to independently develop its product candidates in indications and geographies with clear clinical and regulatory approval pathways where it can commercialize successfully on its own, if approved. Tvardi may also seek to establish strategic partnerships around certain product candidates in disease areas or geographies that are better served by the resources or specific expertise of other biopharm