PLRX Pliant Therapeutics Inc.

20.2
-2.95  -13%
Previous Close 23.15
Open 23.13
52 Week Low 18.28
52 Week High 43.92
Market Cap $725,068,072
Shares 35,894,459
Float 21,208,317
Enterprise Value $567,119,725
Volume 301,605
Av. Daily Volume 105,995
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Drug Pipeline

Drug Stage Notes
PLN-74809
Idiopathic pulmonary fibrosis
Phase 2a
Phase 2a
Phase 2a trial to complete enrollment by end of 2021.
PLN-74809
Primary sclerosing cholangitis
Phase 2a
Phase 2a
Phase 2a trial to complete enrollment 1H 2022.
PLN-1474
Liver fibrosis associated with NASH
Phase 1
Phase 1
Phase 1 trial has completed - well tolerated with no dose- or treatment-limiting toxicities or severe/serious adverse events observed.

Latest News

  1. - 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…

    - 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 αvβ6. The goal of the trial is to confirm the ability of PLN-74809, a dual selective inhibitor of αvβ6vβ1, to penetrate highly fibrotic areas of the lung where αvβ6 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 αvβ6 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 αvβ1 integrin-mediated activation of TGF-β, 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 increase was due to higher personnel-related and professional services expenses.
    • Net loss of $22.9 million as compared to a net income of $11.0 million for the prior-year quarter due to a decrease in related party revenue driven by the achievement of a first-patient-first-dose milestone in the first quarter of 2020 for the PLN-1474 Phase 1 trial.
    • As of March 31, 2021, the Company had cash, cash equivalents and short-term investments of $264.1 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. Pliant's lead product candidate, 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. 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 in the lead indications of IPF, PSC. Pliant has also developed PLN-1474, a small-molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to our development partnership. 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 TwitterLinkedInFacebook, and YouTube.

    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 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 risk that we may not realize the intended benefits of our collaboration, 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 Annual Report on Form 10-K filed with the SEC on March 16, 2021, as updated by our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which we are filing with the SEC today, each 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 Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.



    Pliant Therapeutics, Inc.

    Condensed Statements of Operations

    (Unaudited)

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

     Three Months Ended

    March 31,
     2021 2020
    Revenue — related party$2,174  $28,938 
    Operating expenses:   
    Research and development(18,527) (13,919)
    General and administrative(6,566) (4,011)
    Total operating expenses(25,093) (17,930)
    (Loss) income from operations(22,919) 11,008 
    Interest and other income (expense), net63  21 
    Net (loss) income$(22,856) $11,029 
    Less: Undistributed earnings to preferred stockholders  (11,029)
    Net loss attributable to common stockholders$(22,856) $ 
    Net loss per share, attributable to common stockholders:   
    Basic$(0.64) $ 
    Diluted$(0.64) $ 
    Shares used in computing net loss per share attributable to common stockholders:   
    Basic35,645,205  1,897,669 
    Diluted35,645,205  1,897,669 
    Comprehensive income (loss):   
    Net income (loss)$(22,856) $11,029 
    Net unrealized gain (loss) on short-term investments$14  $60 
    Total other comprehensive income14  60 
    Comprehensive income (loss)$(22,842) $11,089 

    Pliant Therapeutics, Inc.

    Condensed Balance Sheets

    (Unaudited)

    (In thousands)

     March 31,

    2021
     December 31,

    2020
    Assets   
    Current assets   
    Cash and cash equivalents$50,819  $50,882 
    Short-term investments213,281  226,012 
    Accounts receivable2,174  9,279 
    Tax credit receivable83  83 
    Prepaid expenses and other current assets4,180  4,498 
    Total current assets270,537  290,754 
    Property and equipment, net4,266  4,321 
    Other non-current assets451  451 
    Total assets$275,254  $295,526 
    Liabilities and Stockholders' Equity   
    Current liabilities   
    Accounts payable$2,886  $2,023 
    Accrued liabilities7,364  9,576 
    Total current liabilities10,250  11,599 
    Other long-term liabilities835  866 
    Total liabilities11,085  12,465 
    Stockholders' equity   
    Common stock3  3 
    Additional paid-in capital404,868  400,918 
    Accumulated deficit(140,684) (117,828)
    Accumulated other comprehensive loss(18) (32)
    Total stockholders' equity264,169  283,061 
    Total liabilities and stockholders' equity$275,254  $295,526 


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  2. SOUTH SAN FRANCISCO, Calif., May 05, 2021 (GLOBE NEWSWIRE) -- 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 participation in the 2021 RBC Capital Markets Global Healthcare Conference to be held virtually from May 18 –19, 2021.

    Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in a virtual fireside chat with RBC's Brian Abrahams, on Tuesday, May 18, 2021 at 4:15 p.m. EDT / 1:15 p.m. PDT and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    The live and archived event can be accessed…

    SOUTH SAN FRANCISCO, Calif., May 05, 2021 (GLOBE NEWSWIRE) -- 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 participation in the 2021 RBC Capital Markets Global Healthcare Conference to be held virtually from May 18 –19, 2021.

    Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in a virtual fireside chat with RBC's Brian Abrahams, on Tuesday, May 18, 2021 at 4:15 p.m. EDT / 1:15 p.m. PDT and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    The live and archived event can be accessed by visiting the "News & Events" section of the "Investors & Media" page of the Pliant Therapeutics' website at www.pliantrx.com. The event will be available for 90 days.

    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 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. 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 in the lead indications of IPF, PSC. Pliant has also developed PLN-1474, a small-molecule selective inhibitor of αvß1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has transferred to Novartis pursuant to our development partnership. 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 TwitterLinkedInFacebook, and YouTube.

    Investor and Media Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.



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  3. SOUTH SAN FRANCISCO, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- 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 participation in the 20th Annual Needham Healthcare Conference to be held virtually from April 12 –15, 2021.

    Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in a fireside chat with Needham and Company's senior biotech analyst, Joseph Stringer, on Tuesday, April 13, 2021 at 12:45 p.m. EDT / 9:45 a.m. PDT and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    The live…

    SOUTH SAN FRANCISCO, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- 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 participation in the 20th Annual Needham Healthcare Conference to be held virtually from April 12 –15, 2021.

    Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in a fireside chat with Needham and Company's senior biotech analyst, Joseph Stringer, on Tuesday, April 13, 2021 at 12:45 p.m. EDT / 9:45 a.m. PDT and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    The live and archived event can be accessed by visiting the "News & Events" section of the "Investors & Media" page of the Pliant Therapeutics' website at www.pliantrx.com. The event will be available for 90 days.

    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. 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 TwitterLinkedInFacebook, and YouTube.

    Investor and Media Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.





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  4. - PLN-74809 Phase 2a PET Imaging Trial Resumed, with Preliminary Data Expected First Half of 2021

    - PLN-74809 Phase 2a 12-week trials in IPF and PSC Gained Momentum in the Fourth Quarter, Currently on Track to Complete Enrollment by the End of 2021 and First Half of 2022, Respectively

    SOUTH SAN FRANCISCO, Calif., March 16, 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 fourth quarter and full year 2020 financial results.

    "We entered 2021 in a strong position resulting from our team's execution throughout the fourth quarter despite the…

    - PLN-74809 Phase 2a PET Imaging Trial Resumed, with Preliminary Data Expected First Half of 2021

    - PLN-74809 Phase 2a 12-week trials in IPF and PSC Gained Momentum in the Fourth Quarter, Currently on Track to Complete Enrollment by the End of 2021 and First Half of 2022, Respectively

    SOUTH SAN FRANCISCO, Calif., March 16, 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 fourth quarter and full year 2020 financial results.

    "We entered 2021 in a strong position resulting from our team's execution throughout the fourth quarter despite the challenges of the evolving backdrop of the COVID-19 pandemic," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "Our focus remains on continuing to actively drive our lead Phase 2a programs in IPF and PSC towards near term data readouts, to advance our earlier-stage oncology and muscular dystrophy portfolio towards the clinic while also leveraging our robust discovery engine to create a broad and differentiated product portfolio focused on delivering novel treatments to areas of unmet medical need."

    Fourth Quarter and Recent Highlights

    • PLN-74809 Phase 2a positron emission tomography (PET) imaging trial resumed, with preliminary data expected in the first half 2021. With the reopening of the trial site in November, we were able to resume the Phase 2a PET trial. This open-label dose ranging trial will evaluate target engagement of PLN-74809 in IPF patients utilizing a PET tracer of the integrin αvβ6. We will assess receptor occupancy levels achieved by PLN-74809, a dual selective inhibitor of αvβ6vβ1, across multiple single-dose cohorts.



    • PLN-74809 Phase 2a INTEGRIS trials in idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) gained momentum in the fourth quarter and are currently on track to complete enrollment by the end of 2021 and the first half of 2022, respectively. These 12-week randomized, dose-ranging, double-blind, placebo-controlled trials will evaluate safety, tolerability, and pharmacokinetics, as well as exploratory efficacy endpoints in patients with IPF and PSC.



    • IND open for development of a PET tracer of the protein integrin αvβ1. Following a December 2020 Investigational New Drug (IND) filing and the recently issued a "Safe to Proceed Letter", Pliant expects to rapidly advance into clinical trials a study of a wholly owned αvβ1 PET tracer to evaluate expression levels of αvβ1 in various fibrotic tissues. This marks the Company's fifth IND.

    • 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 αvβ1 integrin-mediated activation of TGF-β, reducing liver fibrosis in animal models. Following the successful completion of this study, PLN-1474 has been transferred to Novartis.

    Leadership Team

    • The Company appointed Gregory P. Cosgrove, M.D., FCCP as Vice President of Clinical Development to lead the execution of the IPF clinical development program. Dr. Cosgrove brings to Pliant over 20 years of pulmonary and critical care expertise in academic clinical research. Dr. Cosgrove most recently served as Associate Professor at the National Jewish Health in Denver, Colorado, the leading respiratory hospital in the United States and as the Chief Medical Officer of the Pulmonary Fibrosis Foundation, a leading pulmonary fibrosis focused nonprofit organization.
    • The Company appointed Dr. David Pyott to the Company's Board of Directors. Dr. Pyott brings over 30 years of leadership and management experience with expertise in organizational scaling to the Company. Most recently, Dr. Pyott served as Chairman and Chief Executive Officer of Allergan Inc., a role he held for over 17 years.

    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 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 long-term impacts of the pandemic become better understood.

    Fourth Quarter 2020 Financial Results

    • Research and development expenses were $17.9 million, as compared to $11.7 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 $5.6 million, as compared to $3.1 million for the same period in 2019. The increase was due to higher personnel-related and professional services expenses.
    • Net loss of $19.0 million as compared to a net income of $42.2 million for the prior-year quarter due to a decrease in related party revenue.
    • As of December 31, 2020, the Company had cash, cash equivalents and short-term investments of $276.9 million. 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 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. 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 in the lead indications of IPF, PSC. Pliant's second product candidate, PLN-1474, is a small-molecule selective inhibitor of αvß1for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has partnered with Novartis. 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 TwitterLinkedInFacebook, and YouTube.

    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, the Quarterly Report for the second quarter of 2020 filed with the SEC on Form 10-Q on August 11, 2020, and the Quarterly Report for the third quarter of 2020 filed with the SEC on Form 10-Q on November 10, which are available on the SEC's website at www.sec.gov. Additional information will be made available in Pliant Therapeutics Annual Report on Form 10-K for the year ended December 31, 2020 forward looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

    Investor and Media Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.

    Pliant Therapeutics, Inc.

    Condensed Statements of Operations

    (Unaudited)

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

      Three Months Ended December 31,  Year Ended December 31, 
      2020  2019  2020  2019 
    Revenue — related party $4,465  $57,052  $41,817  $57,052 
    Operating expenses:                
    Research and development  (17,854)  (11,727)  (66,193)  (47,353)
    General and administrative  (5,627)  (3,103)  (17,269)  (10,930)
    Total operating expenses  (23,481)  (14,830)  (83,462)  (58,283)
    (Loss) income from operations  (19,016)  42,222   (41,645)  (1,231)
    Interest income  86   115   478   816 
    Other expense, net  (97)  (168)  (366)  (216)
    Net (loss) income $(19,027) $42,169  $(41,533) $(631)
    Accretion to redemption value and dividends on redeemable convertible preferred stock     (2,147)     (6,225)
    Less: Undistributed earnings to preferred shareholders     (13,789)      
    Net (loss) income attributable to common stockholders $(19,027) $26,233  $(41,533) $(6,856)
    Net (loss) income per share, attributable to common stockholders:                
    Basic $(0.54) $15.82  $(1.95) $(4.22)
    Diluted $(0.54) $1.50  $(1.95) $(4.22)
    Shares used in computing net (loss) income per share attributable to common stockholders:                
    Basic  35,495,414   1,658,559   21,344,236   1,623,358 
    Diluted  35,495,414   17,527,829   21,344,236   1,623,358 
                     





    Pliant Therapeutics, Inc.

    Condensed Balance Sheets

    (Unaudited)

    (In thousands)

      December 31,

    2020
      December 31,

    2019
     
    Assets        
    Current assets        
    Cash and cash equivalents $50,882  $85,807 
    Short-term investments  226,012   16,966 
    Accounts receivable  9,279   7,052 
    Tax credit receivable  83   333 
    Prepaid expenses and other current assets  4,498   1,742 
    Total current assets  290,754   111,900 
    Property and equipment, net  4,321   4,079 
    Other non-current assets  451   3,085 
    Total assets $295,526  $119,064 
    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)        
    Current liabilities        
    Accounts payable $2,023  $1,250 
    Accrued liabilities  9,576   6,922 
    Total current liabilities  11,599   8,172 
    Other long-term liabilities  866   912 
       Total liabilities  12,465   9,084 
    Series A redeemable convertible preferred stock     62,468 
    Series B redeemable convertible preferred stock     75,860 
    Series C redeemable convertible preferred stock     47,947 
    Stockholders' equity (deficit)        
    Preferred stock      
    Common stock  3   1 
    Additional paid-in capital  400,918    
    Accumulated deficit  (117,828)  (76,295)
    Accumulated other comprehensive loss  (32)  (1)
       Total stockholders' equity (deficit)  283,061   (76,295)
    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) $295,526  $119,064 
             

     



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  5. SOUTH SAN FRANCISCO, Calif., March 16, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced the successful completion of a Phase 1 trial of PLN-1474, an oral, small-molecule selective inhibitor of the integrin αvβ1 in development for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Following the successful completion of this study, PLN-1474 has been transferred to Novartis.

    The Phase 1 trial of PLN-1474 was a safety, tolerability, and pharmacokinetics dose-escalating first-in-human study that enrolled 84 healthy volunteers. PLN-1474 was rapidly absorbed and…

    SOUTH SAN FRANCISCO, Calif., March 16, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, today announced the successful completion of a Phase 1 trial of PLN-1474, an oral, small-molecule selective inhibitor of the integrin αvβ1 in development for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis. Following the successful completion of this study, PLN-1474 has been transferred to Novartis.

    The Phase 1 trial of PLN-1474 was a safety, tolerability, and pharmacokinetics dose-escalating first-in-human study 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 αvβ1 integrin-mediated activation of TGF-β, reducing liver fibrosis in animal models.

    "Our team's successful Phase 1 development of PLN-1474 places this novel therapeutic in a strong position as we transfer it to Novartis," said Éric Lefebvre, M.D., Chief Medical Officer of Pliant Therapeutics. "With these first-in-human study results in healthy volunteers showing that PLN-1474 was readily absorbed and generally well tolerated, we look forward to the program's next steps under Novartis."

    Pursuant to the October 2019 Collaboration and License Agreement between the two companies, following Pliant's completion of Phase 1, the PLN-1474 Investigational New Drug (IND) Application has been transferred to Novartis who will be responsible for all future development, manufacturing, and commercialization activities.

    About the Collaboration and License Agreement

    In October 2019, Pliant and Novartis entered into a Collaboration and License Agreement for the development and commercialization of PLN-1474 and up to three integrin research targets. Pliant received a $50 million upfront fee for a worldwide exclusive license on PLN-1474 as well as $30 million in equity investment commitments from Novartis. Pliant is expected to receive reimbursement for research and development activities under the collaboration. Pliant is eligible to receive milestone payments of up to $416 million on achievement of development, regulatory and commercialization milestones, as well as tiered royalties ranging from mid-single digit to low double-digit percentages.

    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 and our collaboration with Novartis for PLN-1474 and the potential and intended benefits of such collaboration. 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 our dependence on Novartis for future development of PLN-1474, 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 third quarter of 2020 filed with the SEC on Form 10-Q on November 10, 2020 which are available on the SEC's website at www.sec.gov.

    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 αvβ6 and αvβ1 integrins that is in development for the treatment of idiopathic pulmonary fibrosis, or IPF, primary sclerosing cholangitis, or PSC, and COVID-19 related ARDS. 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 clinical stage product candidate, PLN-1474, is a small-molecule selective inhibitor of αvβ1 for the treatment of nonalcoholic steatohepatitis, or NASH with liver fibrosis, which Pliant has partnered with Novartis. 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 TwitterLinkedIn, Facebook, and YouTube.

    Investor and Media Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.



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