Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 40

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 40
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Tvardi is a clinical-stage biopharmaceutical company
focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant
unmet need. Based upon Tvardi’s founder’s seminal work and deep understanding of the transcription factor STAT3, Tvardi has
designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise,
Tvardi is developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing. Tvardi’s
lead product candidate, TTI-101, is currently in Phase 2 clinical development in hepatocellular carcinoma (HCC). Tvardi expects to report
preliminary topline data from its Phase 1b/2 HCC clinical trial in the first half of 2026. Tvardi’s second product candidate, TTI-109,
is also an oral, small molecule STAT3 inhibitor that is structurally related to, yet chemically distinct from, TTI-101 and is designed
to enhance Tvardi’s ability to target STAT3. Tvardi submitted an Investigational New Drug (IND) application for TTI-109 in June
2025. After U.S. Food and Drug Administration (FDA) acceptance of the IND, Tvardi has initiated a Phase 1 trial of TTI-109 in healthy
volunteers to evaluate safety, tolerability, and pharmacokinetics, as well as bioequivalence to TTI-101. The study is ongoing and Tvardi
expects to report out topline data from this trial in the first half of 2026. In October 2025, Tvardi reported preliminary data from its
Phase 2 clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF) and concluded that the study did not meet its goals. Tvardi is
conducting additional analyses to further understand these results and inform next steps.

Since commencing operations in 2017, Tvardi has
devoted substantially all of its efforts and financial resources to developing its product candidates, organizing and staffing its company,
business planning, raising capital, establishing its intellectual property portfolio and performing research and development of its product
candidates, signaling and biology, medicinal chemistry and clinical insights to discover and develop novel therapies for the treatment
of fibrosis-driven diseases. Through the date of this filing, Tvardi has historically financed its