PLRX Pliant Therapeutics Inc.

27.52
-5.47  -17%
Previous Close 32.99
Open 31.27
52 Week Low 19.425
52 Week High 35.63
Market Cap $976,405,555
Shares 35,479,853
Float 34,953,530
Enterprise Value $876,864,350
Volume 229,937
Av. Daily Volume 109,972
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Upcoming Catalysts

Drug Stage Catalyst Date
PLN-1474
Liver fibrosis associated with NASH
Phase 1
Phase 1
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PLN-74809
Idiopathic pulmonary fibrosis
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
PLN-74809
Primary sclerosing cholangitis
Phase 2a
Phase 2a
Phase 2a trial enrolling.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., Nov. 19, 2020 /PRNewswire/ -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced its participation in the Piper Sandler 32nd Annual Healthcare Conference to be held virtually December 1 – 3, 2020.

    Bernard Coulie, M.D., Ph.D., president and chief executive officer of Pliant Therapeutics, will participate in a fireside chat with Tyler M. Van Buren, senior biotechnology analyst at Piper Sandler. The fireside chat will be pre-recorded and available beginning on Monday, November 23, 2020 at 10:00 am ET by visiting the "News & Events" section of the "Investors & Media" page of the Pliant Therapeutics' website at www.pliantrx.com.

    The webcast replay of the fireside chat will be archived for 90 days following the conclusion of the event.

    About Pliant Therapeutics, Inc.

    Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of avß6 and avß1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 for the treatment of IPF and PSC. Pliant's second product candidate, PLN-1474, is a small-molecule selective inhibitor of avß1 for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis, or NASH, which Pliant has partnered with Novartis. PLN-1474 is currently undergoing a Phase 1 trial. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant Therapeutics, visit www.pliantrx.com and follow us on Twitter, LinkedIn, and Facebook.

    Investor Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.

    Media Contact:

    Cambria Fuqua

    Canale Communications

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-to-participate-in-the-piper-sandler-32nd-annual-virtual-healthcare-conference-301176485.html

    SOURCE Pliant Therapeutics, Inc.

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  2. SOUTH SAN FRANCISCO, Calif., Nov. 10, 2020 /PRNewswire/ -- 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 2020 financial results.

    "Reflecting back on the first three quarters of 2020, I'm proud of the progress we've made despite the challenges related to the COVID-19 pandemic," said Bernard Coulie, M.D., Ph.D., Chief Executive Officer and President of Pliant Therapeutics. "We closed a successful IPO, took important steps in advancing our clinical programs across four indications, and further strengthened our leadership team. Looking ahead, with a strong cash position to advance our robust pipeline, we remain deeply committed to bringing novel treatments to people with fibrotic diseases."

    Recent Highlights

    • Enrollment of Phase 2a 12-week trials of PLN-74809 in idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) progressing. After resuming enrollment earlier in the year, Pliant has remained in close coordination with its global trial sites in order to facilitate enrollment in both Phase 2a trials. The Company also continues to open additional trial sites as COVID-19 related restrictions are eased. The hybrid approach to clinical trial participation utilizing home-health solutions to maximize patient safety is expected to aid in trial recruitment.
    • Phase 2a PET imaging trial of PLN-74809 in IPF is enrolling. The Phase 2a PET trial will evaluate safety, tolerability, and target engagement of PLN-74809 in IPF patients. We expect to report preliminary data by the first half of 2021.
    • Completed dosing of an extended Phase 1 dose escalation trial of PLN-74809 in healthy volunteers. PLN-74809 has completed dosing multiple ascending dose cohorts of 120mg and 160mg once daily in an extended dose escalation trial. The pharmacokinetic profile remains in line with previous cohorts, and PLN-74809 remains generally well tolerated with no drug related severe adverse events or serious adverse events reported in either cohort.
    • Phase 2a trial of PLN-74809 treatment of COVID-19 related acute respiratory distress syndrome (ARDS) has been initiated. The Company initiated a Phase 2a trial evaluating safety, tolerability and pharmacokinetics (PK) of PLN-74809, as well as exploratory clinical outcome measures in patients hospitalized with severe and critical COVID-19.
    • Phase 1 trial of PLN-1474 in healthy volunteers is nearing completion. The Phase 1 trial is designed to evaluate safety and tolerability, as well as PK of PLN-1474 in approximately 100 healthy volunteers across a dose range compared to placebo. After resuming enrollment following delays related to COVID-19, the trial remains on track to deliver topline data by the first quarter of 2021. PLN-1474 is partnered with Novartis.

    COVID-19 Preparedness

    Pliant continues to develop policies and procedures to enable the Company 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. Pliant is working closely with clinical sites to continue site initiation and operation activities in compliance with study protocols while observing government and institutional guidelines.  The Company intends to provide more specific guidance regarding clinical trial progress and the timing of data readouts as the impacts of the pandemic become better understood.

    Third-Quarter 2020 Financial Results

    • Related party revenue was $4.8 million, as compared to none for the prior-year quarter.
    • Research and development expenses were $16.9 million, as compared to $10.8 million for the prior-year quarter. The increase was due primarily to higher costs related to the advancement of several programs and ongoing Phase 1/2 clinical trials.
    • General and administrative expenses were $4.6 million, as compared to $2.6 million for the same period in 2019. The increase was due to higher personnel-related and professional services expenses.
    • Net loss of $16.5 million as compared to a net loss of $13.3 million for the prior-year quarter.
    • As of September 30, 2020, Pliant had cash, cash equivalents and short-term investments of $294.0 million, compared to $312.5 million as of June 30, 2020. Pliant 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. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of avß6 and avß1 integrins that it is developing for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 for the treatment of IPF and PSC. Pliant's second product candidate, PLN-1474, is a small-molecule selective inhibitor of avß1 for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis, or NASH, which Pliant has partnered with Novartis. PLN-1474 is currently undergoing a Phase 1 trial. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant Therapeutics, visit www.pliantrx.com and follow us on Twitter, LinkedIn, and Facebook.

    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 our product candidates, including their development and therapeutic potential, the advancement of our clinical and preclinical pipeline, including the timing, enrollment and results of our clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical trials, clinical supply and plans, our collaboration with Novartis for PLN-1474 and the intended benefits of such collaborations, and our financial position and cash runway. 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 any delays in our ongoing or planned preclinical or clinical trials, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, 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, 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 prospectus dated June 3, 2020 as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, and the Quarterly Report for the second quarter of 2020 filed with the SEC on Form 10-Q on August 11, 2020  which are available on the SEC's website at www.sec.gov. Additional information will be made available in Pliant Therapeutics quarterly report on Form 10-Q for the quarter ended September 30, 2020 forward looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

    Investor Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.

    Media Contact:

    Cambria Fuqua

    Canale Communications

     

    Pliant Therapeutics, Inc.

    Condensed Statements of Operations and Comprehensive Loss

    (Unaudited)

    (In thousands, except number of shares and per share amounts)







    Three Months Ended

    September 30,





    Nine Months Ended

    September 30,







    2020





    2019





    2020





    2019



    Revenue — related party



    $

    4,814





    $





    $

    37,352





    $



    Operating expenses:

































    Research and development





    (16,884)







    (10,779)







    (48,339)







    (35,626)



    General and administrative





    (4,591)







    (2,583)







    (11,642)







    (7,827)



    Total operating expenses





    (21,475)







    (13,362)







    (59,981)







    (43,453)



    Loss from operations





    (16,661)







    (13,362)







    (22,629)







    (43,453)



    Interest income





    72







    148







    392







    701



    Other income (expense), net





    55







    (41)







    (269)







    (48)



    Net loss



    $

    (16,534)





    $

    (13,255)





    $

    (22,506)





    $

    (42,800)



    Accretion to redemption value and cumulative dividends on

       redeemable convertible preferred stock











    (1,375)













    (4,078)



    Net loss attributable to common stockholders



    $

    (16,534)





    $

    (14,630)





    $

    (22,506)





    $

    (46,878)



    Net loss per share, attributable to common stockholders:

































    Basic



    $

    (0.47)





    $

    (8.53)





    $

    (1.36)





    $

    (30.03)



    Diluted



    $

    (0.47)





    $

    (8.53)





    $

    (1.36)





    $

    (30.03)



    Shares used in computing net loss per share attributable

       to common stockholders:

































    Basic





    35,445,504







    1,714,285







    16,592,746







    1,561,242



    Diluted





    35,445,504







    1,714,285







    16,592,746







    1,561,242



    Comprehensive loss:

































    Net loss



    $

    (16,534)





    $

    (13,255)





    $

    (22,506)





    $

    (42,800)



    Net unrealized gain (loss) on short-term investments



    $

    12





    $

    (10)





    $

    (17)





    $

    1



    Total other comprehensive income (loss)





    12







    (10)







    (17)







    1



    Comprehensive loss



    $

    (16,522)





    $

    (13,265)





    $

    (22,523)





    $

    (42,799)



     

    Pliant Therapeutics, Inc.

    Condensed Balance Sheets

    (Unaudited)

    (In thousands, except number of shares and per share amounts)  







    September 30,

    2020





    December 31,

    2019



    Assets

















    Current assets

















    Cash and cash equivalents



    $

    55,224





    $

    85,807



    Short-term investments





    238,776







    16,966



    Accounts receivable





    7,131







    7,052



    Tax credit receivable





    83







    333



    Prepaid expenses and other current assets





    6,515







    1,742



    Total current assets





    307,729







    111,900



    Property and equipment, net





    4,144







    4,079



    Other non-current assets





    451







    3,085



    Total assets



    $

    312,324





    $

    119,064



    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity

    (Deficit)

















    Current liabilities

















    Accounts payable



    $

    3,140





    $

    1,250



    Accrued liabilities (Note 5)





    7,886







    6,922



    Total current liabilities





    11,026







    8,172



    Other long-term liabilities (Note 5)





    952







    912



    Total liabilities





    11,978







    9,084



    Commitments and Contingencies (Note 13)

















    Preferred stock, $0.0001 par value; 10,000,000 shares and 0 shares

       authorized at September 30, 2020 and December 31, 2019, respectively;

       0 shares issued and outstanding at September 30, 2020

       and December 31, 2019;













    Series A redeemable convertible preferred stock, $0.0001 par value;

       0 and 56,000,000 shares authorized at September 30, 2020

       and December 31, 2019, respectively; 0 and 56,000,000 shares

       issued and outstanding, at September 30, 2020 and December 31, 2019,

       respectively; aggregate liquidation preference of $0 and

       $62,468 at September 30, 2020 and December 31, 2019, respectively;











    62,468



    Series B redeemable convertible preferred stock, $0.0001 par value;

       0 shares and 49,501,221 shares authorized at September 30, 2020 and

       December 31, 2019, respectively; 0 shares and 49,501,221 shares

       issued and outstanding at September 30, 2020 and December 31, 2019,

       respectively; aggregate liquidation preference of $0 and $75,860

       at September 30, 2020 and December 31, 2019, respectively;











    75,860



    Series C redeemable convertible preferred stock, $0.0001 par value;

       0 shares and 44,000,000 shares authorized at September 30, 2020 and

       December 31, 2019, respectively; 0 shares and 26,360,745 shares

       issued and outstanding at September 30, 2020 and December 31, 2019,

       respectively; aggregate liquidation preference of $0 and $47,947

       at September 30, 2020 and December 31, 2019,  respectively;











    47,947



    Stockholders' equity (deficit)

















    Common stock, $0.0001 par value; 300,000,000 and 181,000,000 shares authorized

       at September 30, 2020 and December 31, 2019; and 35,465,715 and 1,846,024 shares

       issued and outstanding at September 30, 2020 and December 31, 2019, respectively;





    3







    1



    Additional paid-in capital





    399,162









    Accumulated deficit





    (98,801)







    (76,295)



    Accumulated other comprehensive loss





    (18)







    (1)



    Total stockholders' equity (deficit)





    300,346







    (76,295)



    Total liabilities, redeemable convertible preferred stock and stockholders' equity

    (deficit)



    $

    312,324





    $

    119,064



     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-provides-corporate-update-and-reports-third-quarter-2020-financial-results-301170058.html

    SOURCE Pliant Therapeutics, Inc.

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  3. SOUTH SAN FRANCISCO, Calif., Nov. 9, 2020 /PRNewswire/ -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced a poster presentation at The Liver Meeting® 2020 hosted by the American Association for the Study of Liver Diseases (AASLD) to be held virtually November 13 – 16, 2020.

    Details for the poster presentation at The Liver Meeting are as follows:

    Poster Title: Profiling Fibrosis Regression in a Rat Model of Non-Alcoholic Steatohepatitis (Abstract #0321)

    Session: Basic Fibrosis Research and Stellate Cell Biology

    Time/Date: Friday, November 13, 2020: 6:00 AM11:55 PM EDT

    The presentation is available to registered participants via the AASLD 2020 website. The poster will be available on the Pliant Therapeutics website, under the "Our Science" section, at www.pliantrx.com on November 13.

    About Pliant Therapeutics, Inc.

    Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of avß6 and avß1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 for the treatment of IPF and PSC. Pliant's second product candidate, PLN-1474, is a small-molecule selective inhibitor of avß1 for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis, or NASH, which Pliant has partnered with Novartis. PLN-1474 is currently undergoing a Phase 1 trial. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant Therapeutics, visit www.pliantrx.com and follow us on Twitter, LinkedIn, and Facebook.

    Investor Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.

    mailto:

    Media Contact:

    Cambria Fuqua

    Canale Communications

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-to-present-data-at-the-liver-meeting-2020-301168419.html

    SOURCE Pliant Therapeutics, Inc.

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  4. SOUTH SAN FRANCISCO, Calif., Oct. 5, 2020 /PRNewswire/ -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced the appointment of Mike Ouimette as general counsel and corporate secretary of the company.

    "Mike is an accomplished biotech executive who brings deep legal and regulatory experience, as well as deal making expertise to Pliant," said Bernard Coulie, M.D., Ph.D., president and CEO of Pliant Therapeutics. "He shares our team's passion to advance our lead programs into the clinic and transform the lives of people living with fibrotic diseases."

    Mr. Ouimette brings more than 20 years of legal experience to the company, most recently serving as vice president and assistant secretary of Portola Pharmaceuticals, Inc. prior to the acquisition of Portola by Alexion Pharmaceuticals, Inc. Mr. Ouimette  also served as senior corporate counsel and assistant secretary of Onyx Pharmaceuticals Inc., prior to the acquisition of Onyx by Amgen Inc. Prior to Onyx, Mr. Ouimette was a partner in the San Francisco office of the international law firm of Pillsbury Winthrop Shaw Pittman LLP, where his practice focused on mergers and acquisitions, capital formation, and other public company and regulatory matters. Mr. Ouimette received his J.D. from UCLA School of Law, and A.B. from University of California, Davis.

    About Pliant Therapeutics, Inc.

    Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of avß6 and avß1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 for the treatment of IPF and PSC.  Pliant's second product candidate, PLN-1474, is a small-molecule selective inhibitor of avß1 for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis, or NASH, which Pliant has partnered with Novartis. PLN-1474 is currently undergoing a Phase 1 trial. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies.

    Investor Contact:

    Media Contact:

    Cambria Fuqua

    Canale Communications

    (619) 849-5390

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    SOURCE Pliant Therapeutics, Inc.

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  5. SOUTH SAN FRANCISCO, Calif., Sept. 24, 2020 /PRNewswire/ -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, today announced its data presentation at the American Thoracic Society (ATS) 2020 Virtual Sessions.  Pliant is evaluating PLN-74809 in fibrotic diseases with high unmet medical need, including idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC).

    Presentation: PLN-74809, A Dual αVβ6/αVβ1, Oral, Selective Integrin Inhibitor, Is Well Tolerated and Reduces Lung TGF-β Activity in Healthy Volunteers

    The presentation will be available through November 10, 2020 to registered participants via the ATS 2020 website.

    About Pliant Therapeutics, Inc.

    Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of avß6 and avß1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC. Pliant is currently recruiting Phase 2a trials of PLN-74809 for the treatment of IPF and PSC.  Pliant's second product candidate, PLN-1474, is a small-molecule selective inhibitor of avß1 for the treatment of liver fibrosis associated with nonalcoholic steatohepatitis, or NASH, which Pliant has partnered with Novartis. PLN-1474 is currently undergoing a Phase 1 trial. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies.

    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. These statements, which include those regarding our research and potential antifibrotic benefits, are subject to risks and uncertainties identified under the heading "Risk Factors" included in our quarterly report on Form 10-Q for the quarter ended June 30, 2020 and in future filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect our current views with respect to future events, and we do not undertake and specifically disclaim any obligation to update any forward-looking statements.

    Investor Contact:

    Media Contact:

    Cambria Fuqua

    Canale Communications

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    SOURCE Pliant Therapeutics, Inc.

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