Release Details

HOUSTON, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi” or the “Company”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, today announced that it will host a KOL webinar on Wednesday, August 19, 2026 at 11:00 AM ET featuring Randy Longman, MD, PhD (Weill Cornell Medicine), who will join Tvardi management to discuss the current treatment landscape in ulcerative colitis (UC) and the persistent unmet needs that remain despite recent clinical advances and currently approved therapies.

The event will feature new data from Tvardi and a review of the Phase 1 healthy volunteer results supporting the potential of TTI-109 in UC. The discussion will explore the scientific rationale for targeting STAT3, a convergent node implicated in multiple pathways that contribute to the pathogenesis and persistence of UC. Tvardi management will also discuss the planned clinical development strategy for TTI-109.

Dr. Longman will provide his perspective on the clinical relevance of the findings and how a STAT3 inhibitor could ultimately fit within the UC treatment paradigm.

A live question and answer session will follow the formal presentations.

To register for the webinar, please click here. The live webinar and subsequent replay will also be available on the “Events and Presentations” page under the “Investors” section of the Tvardi website (www.tvarditherapeutics.com).

About Randy Longman, MD, PhD
Randy Longman, MD, PhD, is Director of the Jill Roberts Center for Inflammatory Bowel Disease and an Associate Professor of Medicine at Weill Cornell Medicine, where he also leads research within the Jill Roberts Institute for Research in IBD. He is a gastroenterologist and mucosal immunologist whose research focuses on the microbial and immune mechanisms driving inflammatory bowel disease, including ulcerative colitis and Crohn's disease. Dr. Longman received his undergraduate degree from Yale University, his MD from Weill Cornell Medical College, his PhD in immunology from The Rockefeller University, and completed his clinical training in internal medicine and gastroenterology at Columbia University Medical Center. Dr. Longman has received research funding from many foundations including the NIH, Rainin Foundation, and the Crohn’s and Colitis Foundation. In recognition of his research, he has received the Irma T. Hirschl Career Scientist Award and was recently elected to the American Society for Clinical Investigation. He is currently an associate editor at Journal for Crohn’s and Colitis and a member of the National Scientific Advisory Committee for the Crohn’s and Colitis Foundation.

Planned UC Clinical Trial

Tvardi plans to initiate a study of TTI-109 in patients with moderate-to-severe UC in 2027, subject to clearance of Investigational New Drug (IND) application and additional funding. The primary endpoint will be safety, and the secondary endpoint will be clinical remission at 12 weeks. Exploratory pharmacodynamic endpoints will include serum/tissue biomarkers and analysis of single nucleotide polymorphisms (SNPs).

About Tvardi Therapeutics

Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases with significant unmet need. STAT3 is a central mediator across critical signaling pathways that drive uncontrolled proliferation, survival and immune dysregulation. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The Company has completed a Phase 1 healthy volunteer study of TTI-109 and plans to initiate a clinical trial of TTI-109 in its initial indication, ulcerative colitis, pending IND clearance and the availability of additional funding. The company is also conducting a Phase 1b/2 clinical trial of TTI-101 in hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter).

Contacts:

For Tvardi:
Tvardi Investor Relations
ir@tvardi.com

PJ Kelleher
LifeSci Advisors
617-430-7579
pkelleher@lifesciadvisors.com

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, including TTI-109 in dermatologic and GI therapeutic areas and of the Company’s STAT3 inhibitors, including as compared to single-pathway biologics; the potential benefits of TTI-109 as compared to TTI-101, including improved delivery and tolerability; its ongoing and planned clinical trials, including its ongoing Phase 1b/2 clinical trial of TTI-101 in hepatocellular carcinoma and its planned future trials of TTI-109; the results from the Phase 1 trial of TTI-109 validating the Company’s prodrug strategy and supporting its continued development pathway; the Company’s plans to develop TTI-109 in UC, subject to clearance of an IND application and receipt of additional funding; 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 or safety or other complications related to its product candidates; the ability to obtain IND clearance for TTI-109 in UC on the timelines expected or at all; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; 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 estimated patient populations and total addressable markets for the indications in which Tvardi seeks to develop its product candidates; Tvardi’s anticipated cash runway; 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 Annual Report on Form 10-K for the year ended December 31, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. The 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.