Page 1

PLIANT Pliant Therapeutics Provides Corporate Update and Reports Third Quarter 2021 Financial Results November 9 , 2021 SOUTH SAN FRANCISCO , Calif . , Nov. 09 , 2021 ( GLOBE NEWSWIRE ) -- Pliant Therapeutics , Inc. ( Nasdaq : PLRX ) ( " the Company " ) , a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis , today provided a corporate update and reported third quarter 2021 financial results . " The third quarter was productive for the company , highlighted by the interim data readout from our PET trial which exceeded our expectations , showing a dose response and achieving near target saturation of PLN - 74809 at the higher doses , " said Bernard Coulie , M.D. , Ph.D. , President and Chief Executive Officer of Pliant Therapeutics . " In addition to the positive data readout , our Phase 2a INTEGRIS - IPF and INTEGRIS - PSC programs are making great progress in enrollment , and , with the additional Phase 1b BAL doses , we continue to methodically de - risk the current and future clinical development of PLN - 74809 . ” Third Quarter and Recent Highlights Positive interim results from Phase 2a PET imaging clinical trial show avß6 target engagement up to 98 % in the lungs of patients with idiopathic pulmonary fibrosis ( IPF ) . The ongoing Phase 2a open - label PET imaging clinical trial is evaluating avß6 target engagement levels achieved by PLN - 74809 across single - doses of 60 , 120 , 240 or 320 mg in up to 12 IPF patients . Interim results showed a dose response and a greater than 50 % target engagement across all doses and established a model of the dose and plasma concentration response . Furthermore , these data support potential anti - fibrotic activity of PLN - 74809 at the doses being evaluated in the ongoing Phase 2a INTEGRIS - IPF trial . PLN - 74809 Phase 2a trial in idiopathic pulmonary fibrosis ( IPF ) enrollment on track with topline data anticipated by mid - 2022 . INTEGRIS - IPF is a 12 - week rando ized , dose - ranging , double - blind , placebo - controlled trial evaluating the safety , tolerability and pharmacokinetics of PLN - 74809 at doses of 40 , 80 or 160 mg in IPF patients . Exploratory endpoints include quantitative lung fibrosis ( QLF ) imaging , pulmonary function tests as well as biomarkers . Enrollment is currently on track to be completed by the end of 2021 with topline data anticipated by mid - 2022 . Data anticipated in the first quarter of 2022 from additional doses in the PLN - 74809 Phase 1b proof - of - mechanism study evaluating inhibition of TGF - ß signaling in the lungs of healthy volunteers . In a previously reported Phase 1b proof - of - mechanism study , 40 mg once - daily dosing of PLN - 74809 inhibited activation of TGF - B , a key driver of fibrosis . Based on additional safety and pharmacokinetic data from the Phase 1a study , Pliant initiated an extension of the Phase 1b study . This study extension evaluates inhibition of TGF - B signaling at doses above 40 mg of PLN - 74809 . These data , coupled with the recently reported positive interim Phase 2a PET target engagement data , will provide important information about the relationship between PLN - 74809 plasma exposure , target engagement , TGF - ß signaling inhibition and potential antifibrotic activity across the dose range currently being tested in the INTEGRIS - IPF trial . Data from this Phase 1b study is anticipated in the first quarter of 2022 . PLN - 74809 Phase 2a trial in primary sclerosing cholangitis ( PSC ) enrollment on track . INTEGRIS - PSC is a 12 - week randomized , dose - ranging , double - blind , placebo - controlled trial evaluating the safety , tolerability , and pharmacokinetics PLN - 74809 at doses of 40 , 80 or 160 mg in PSC patients . Exploratory endpoints include fibrosis biomarkers such as Pro - C3 and ELF , changes in ALP and liver imaging . Enrollment is currently anticipated to be completed by mid - 2022 . Muscular Dystrophy and Oncology programs advancing towards IND . Early - stage integrin targeting programs focused on developing novel therapies in oncology and muscular dystrophies continue to advance towards IND . The muscular dystrophy program utilizes an antibody to improve muscle function through activation of an integrin compensatory mechanism . The oncology program focuses on increasing tumor sensitivity to checkpoint inhibitors through small molecule inhibition of avßg . COVID - 19 Preparedness The Company continues to develop and maintain policies and procedures to enable us to operate safely and productively during the COVID - 19 pandemic . The Company has experienced delays in clinical trial operations which have impacted and may further impact the expected timing of data readouts . The Company continues to work closely with clinical sites to continue site initiation and operation activities in compliance with study protocols while observing government and institutional guidelines . Third Quarter 2021 Financial Results • Research and development expenses were $ 21.1 million , as compared to $ 16.9 million for the prior - year quarter . The increase was due primarily to employee related expenses and higher costs related to the advancement of several programs and ongoing Phase 1/2 clinical trials . • General and administrative expenses were $ 7.7 million , as compared to $ 4.6 million for the prior - year quarter . The increase was due to higher personnel - related and professional services expenses . • Net loss of $ 27.0 million as compared to $ 16.5 million for the prior - year quarter due an overall increase in expense associated with our research and development programs as well as personnel - related costs . • As of September 30 , 2021 , the Company had cash , cash equivalents and short - term investments of $ 221.0 million . The Company believes it has sufficient funds to meet its operating and capital requirements into 2023 . About Pliant Therapeutics , Inc. Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis .