Tvardi Therapeutics Announces Presentation at the American Thoracic Society 2025 Annual Conference

Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ:TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced that an abstract will be presented at the American Thoracic Society 2025 Annual Conference, which is being held May 16-21 in San Francisco.

The abstract highlights the role of STAT3 as a master regulator of idiopathic pulmonary fibrosis (IPF). In preclinical studies, TTI-101, Tvardi's STAT3 inhibitor, suppressed fibrotic markers which are not addressed with currently approved therapies (nintedanib and pirfenidone).

Using single-cell RNA sequencing on lung samples from untreated IPF patients and those treated with current approved therapies, McKenna et al. mapped the transcriptional landscape across 40 pulmonary cell types. They found ~60% of IPF-associated dysregulated genes are not addressed by either approved drug, which they termed the "IPF therapeutic gap." They further identified STAT3 as a dominant regulatory transcription factor both in untreated IPF samples and in the "IPF therapeutic gap."

In addition, ex vivo analysis of human lung slices treated with TTI-101, nintedanib or pirfenidone resulted in greater repression of genes within alveolar fibroblast (key effector cells in fibrosis) with TTI-101 vs current approved therapies. Notably, TTI-101 downregulated genes involved in extracellular matrix production, including collagen genes, which were largely unaffected by nintedanib or pirfenidone.

Details of the presentation are as follows:

Tvardi team members will also be hosting a booth:

For additional information, or to register for the conference: https://ats2025.d365.events/

About Tvardi Therapeutics

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. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter).

Cautionary Statement Regarding Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi's product candidates; its ongoing clinical trials; and other statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them.

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi's product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi's ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi's clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi's product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi's plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi's product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi's ability to attract, hire, and retain skilled executive officers and employees; Tvardi's ability to protect its intellectual property and proprietary technologies; Tvardi's reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi's filings with the Securities and Exchange Commission, including the "Risk Factors" section of the Registration Statement on Form S-4, as amended (File No. 333-283900) initially filed with the Securities and Exchange Commission (the "SEC") on December 18, 2024 and declared effective by the SEC on February 14, 2025, and Tvardi's other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The combined company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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For Tvardi:

Tvardi Investor Relations

[email protected]

PJ Kelleher

LifeSci Advisors

617-430-7579

[email protected]