Company: TVRD
Filing Date: 2025-02-14
Form Type: S-4/A
Source: 0001104659-25-013053
Chunk: 143

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: S-4/A
Chunk 143
---
 idiopathic pulmonary fibrosis (IPF), and hepatocellular carcinoma (HCC). Tvardi has no products approved for commercial sale and has not generated any revenue to date. Tvardi has incurred significant net losses since its inception and has financed operations principally through equity and debt financing. Tvardi continues to incur significant research and development and other expenses related to its ongoing operations. Tvardi’s net loss was $16.7 million and $13.0 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, it had an accumulated deficit of $79.5 million. Tvardi has devoted substantially all of its resources and efforts to research and development, and expects that it will be at several years, if ever, before Tvardi has a commercialized product candidate and generates revenue from sales. Even if Tvardi receives marketing approval for and commercializes one or more of its product candidates, Tvardi expects that it will continue to incur substantial research and development and other expenses in order to further develop and, if approved, market additional potential product candidates.

Tvardi expects to continue to incur significant losses for the foreseeable future, and anticipates that its expenses will increase substantially if, and as, it:

<div align='center'>78</div>

TABLE OF CONTENTS

•

advances TTI-101, TTI-109 and its other product candidates through clinical development, and, if successful, later-stage clinical trials;

•

discovers and develops additional product candidates;

•

advances its preclinical development programs into clinical development;

•

experiences delays or interruptions to preclinical studies, clinical trials, receipt of services from its third-party service providers on whom Tvardi relies or its supply chain;

•

seeks and maintains regulatory approvals for any product candidates that successfully complete clinical trials;

•

commercializes TTI-101, TTI-109, any other product candidates and any future product candidates, if approved;

•

increases the amount of research and development activities to identify and develop product candidates;

•

hires additional clinical development, quality control, scientific and management personnel;

•

expands its operational, financial and management systems and increases personnel, including personnel to support its clinical development and manufacturing efforts and operations as a public company;

•

establishes a sales, marketing, medical affairs and distribution infrastructure to commercialize any products for which it may obtain marketing approval and intends to commercialize on its own or jointly with third parties;