PLRX Pliant Therapeutics Inc

Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today announced the presentation of clinical data at The Liver Meeting® 2024 of the American Association for the Study of Liver Diseases (AASLD) being held in San Diego, California.

Bexotegrast, an oral inhibitor of αvβ6 and αvβ1 integrins, was shown to improve markers and symptoms of cholestasis and stabilized markers of liver fibrosis in participants with primary sclerosing cholangitis: Week 24 results from the Phase 2 INTEGRIS-PSC trial

In an oral late breaker presentation, Kris Kowdley, M.D., Director, Liver Institute Northwest and Professor of Medicine, Elson S. Floyd College of Medicine at Washington State University, reviewed the positive data from the INTEGRIS-PSC trial that demonstrated bexotegrast was well tolerated across all doses tested and displayed antifibrotic and anti-cholestatic activity across multiple measures in patients with primary sclerosing cholangitis (PSC). Improvements included improvements in liver stiffness, Enhanced Liver Fibrosis (ELF) scores, as well as liver biochemistry and magnetic resonance imaging (MRI).

Identification of novel inflammatory serum and urinary protein biomarkers for PSC

In a poster presentation, Johanna Schaub, Ph.D., Principal Scientist II, Translational Sciences at Pliant Therapeutics, presented a study that combined two unique proteomic screening approaches to identify novel diagnostic biomarkers in patients with PSC. Results showed the discovery of dozens of putative serum and urine biomarker candidates along with previously described biomarkers, validating this approach. In addition, this approach yielded proteins previously proposed to predict progression in primary biliary cholangitis and cirrhosis, suggesting a role in predicting progression in PSC.

The posters presented at AASLD will be made available on the Publications page of the Pliant website, www.PliantRx.com, at the time of presentation.

About Pliant Therapeutics, Inc.Pliant Therapeutics is a late-stage biopharmaceutical company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant has initiated BEACON-IPF, an adaptive Phase 2b/3 trial of bexotegrast in IPF. Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. In addition, Pliant has received regulatory clearance for the conduct of a Phase 1 study of PLN-101325, a monoclonal antibody agonist of integrin α7β1 targeting muscular dystrophies.

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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. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those regarding the safety, tolerability, pharmacodynamics and therapeutic potential of bexotegrast; our plans for the future development of bexotegrast; and bexotegrast’s potential to become a treatment for PSC. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Pliant Therapeutics could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those related to the development and commercialization of our product candidates, including the impact of current regulatory, macroeconomic and marketplace conditions, our reliance on third parties for critical aspects of our development operations, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, including the availability of additional term loans under our loan facility, and our ability to obtain and maintain intellectual property protection for our product candidates. These and additional risks are discussed in the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Quarterly Report on Form 10-Q for the period ended September 30, 2024, which is available on the SEC's website at www.sec.gov. Unless otherwise noted, Pliant is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Investor and Media Contact:

Christopher KeenanVice President, Investor Relations and Corporate CommunicationsPliant Therapeutics, Inc.ir@pliantrx.com