Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 30

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 30
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 resoliciting stockholder approval ” beginning on page 31 of this proxy statement/prospectus and “ Risk Factors — The Merger may not be completed on the terms or timeline currently contemplated, or at all .” beginning on page 27of this proxy statement/prospectus.

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TABLE OF CONTENTS

#### Tvardi Therapeutics, Inc.
3 Sugar Creek Center Blvd., Suite 525 
 Sugar Land, Texas 77478 
 (713) 489-8654

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. Tvardi is leveraging its deep understanding of the transcription factor, STAT3, to develop a pipeline of oral small molecules with a differentiated mechanism of action to directly inhibit STAT3, a highly validated, yet historically undruggable target. Tvardi’s lead product candidate, TTI-101, is in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), and hepatocellular carcinoma (HCC). Tvardi expects to report unblinded data from the Phase 2 IPF clinical trial in the second half of 2025 and anticipates preliminary topline data from the Phase 1b/2 HCC clinical trial in the second half of 2025. Its second product candidate, TTI-109, is structurally related to, yet chemically distinct from, TTI-101 and is designed to enhance the ability to target STAT3. Tvardi expects to submit an investigational new drug (IND), application for TTI-109 in the first half of 2025.

Tvardi’s approach is rooted in the expertise around STAT3’s functional composition and its critical role in disease pathogenesis, as well as other essential biological functions. Tvardi’s co-founder, David J. Tweardy, M.D., was one of the first to identify that STAT3, when activated by phosphorylation on tyrosine (Y) residue 705, referred to herein as pY-STAT3, acts as a central catalyst across critical fibrotic signaling pathways and is key to the cellular processes associated with fibrosis-driven diseases. Persistent pY-STAT3 drives the development and progression of the pathogenic cascade of fibrosis. By targeting pY-STAT3, Tvardi’s approach is designed to simultaneously modulate each of the