Earnings release
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PLIANT Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2021 Financial Results May 10 , 2021 - PLN - 74809 Phase 2a PET Imaging Trial Continues to Enroll with Preliminary Data Expected First Half of 2021 - PLN - 74809 Phase 2a 12 - week trials in IPF and PSC Currently on Track to Complete Enrollment by the End of 2021 and First Half of 2022 , Respectively SOUTH SAN FRANCISCO , Calif . , May 10 , 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 first quarter 2021 financial results . " During the first quarter , we continued the strong momentum of advancing our broad and novel clinical and development - stage portfolio , " said Bernard Coulie , M.D. , Ph.D. , President and Chief Executive Officer of Pliant Therapeutics . " With this progress and a financial runway taking us into 2023 , we are well positioned to advance toward our objective of bringing potentially transformative treatments to patients in need . " First Quarter and Recent Highlights • PLN - 74809 Phase 2a positron emission tomography ( PET ) imaging trial preliminary data expected in the first half 2021. This open - label , dose ranging trial is evaluating target receptor occupancy levels of PLN - 74809 in the lungs of IPF patients across multiple single - dose cohorts utilizing a PET tracer of the integrin avß6 . The goal of the trial is to confirm the ability of PLN - 74809 , a dual selective inhibitor of α ³6 / αvß₁ , to penetrate highly fibrotic areas of the lung where a ³6 expression is highest and bind to its target receptor . Additionally , the trial will establish a pharmacokinetic / pharmacodynamic ( PK / PD ) relationship between PLN - 74809 plasma exposure and a ³6 receptor occupancy , allowing us to build a PK / PD model that will inform dose selection in later stage trials . • PLN - 74809 Phase 2a INTEGRIS trial in idiopathic pulmonary fibrosis ( IPF ) continued to build momentum , currently on track to complete enrollment by the end of 2021. The primary endpoints of this 12 - week randomized , dose - ranging , double - blind , placebo - controlled trial are the evaluation of PLN - 74809's safety , tolerability , and pharmacokinetics in IPF patients . The Company will also evaluate exploratory efficacy endpoints including Quantitative Lung Fibrosis , or QLF , imaging as well as pulmonary function tests . • PLN - 74809 Phase 2a INTEGRIS trial in primary sclerosing cholangitis ( PSC ) continued to advance , currently on track to complete enrollment in the first half 2022. The primary endpoints of this 12 - week randomized , dose - ranging , double - blind , placebo - controlled trial are the evaluation of PLN - 74809's safety , tolerability , and pharmacokinetics in PSC patients . The Company will also evaluate exploratory efficacy endpoints including fibrosis biomarkers such as Pro - C3 and ELF , changes in ALP , and liver imaging . • Successful completion of PLN - 1474 Phase 1 trial and transfer of PLN - 1474 to Novartis . The Phase 1 trial of PLN - 1474 was a safety , tolerability , and pharmacokinetics dose - escalating first - in - human trial that enrolled 84 healthy volunteers . PLN - 1474 was rapidly absorbed and well tolerated with no dose - or treatment - limiting toxicities or severe / serious adverse events observed . In preclinical studies , PLN - 1474 was observed to selectively block the avß₁ integrin mediated activation of TGF - B , reducing liver fibrosis in animal models . Following the successful completion of this study , PLN - 1474 has been transferred to Novartis . 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 . First Quarter 2021 Financial Results • Research and development expenses were $ 18.5 million , as compared to $ 13.9 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 $ 6.6 million , as compared to $ 4.0 million for the prior - year quarter . The