1. - Single dose administration of PLN-74809 achieved αvβ6 target engagement up to 98% in the lungs of IPF patients

    - All doses achieved target engagement above the threshold for predicted anti-fibrotic activity, with an observed dose-response relationship

    - PLN-74809 reached highly fibrotic regions of the lung and was bound to αvβ6 in IPF patients

    - Data provide insight into potential anti-fibrotic activity of PLN-74809 at the doses being evaluated in the ongoing Phase 2a INTEGRIS-IPF trial

    - Company to host conference call and webcast today at 8:00 a.m. ET

    SOUTH SAN FRANCISCO, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (NASDAQ:PLRX), a clinical stage biotechnology company focused on discovering and developing novel…

    - Single dose administration of PLN-74809 achieved αvβ6 target engagement up to 98% in the lungs of IPF patients

    - All doses achieved target engagement above the threshold for predicted anti-fibrotic activity, with an observed dose-response relationship



    - PLN-74809 reached highly fibrotic regions of the lung and was bound to αvβ6 in IPF patients



    - Data provide insight into potential anti-fibrotic activity of PLN-74809 at the doses being evaluated in the ongoing Phase 2a INTEGRIS-IPF trial

    - Company to host conference call and webcast today at 8:00 a.m. ET

    SOUTH SAN FRANCISCO, Calif., Sept. 07, 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 positive interim results from a Phase 2a positron emission tomography (PET) imaging-based clinical trial of PLN-74809, an oral small molecule dual selective inhibitor of αvβ6vβ1, in patients with idiopathic pulmonary fibrosis (IPF). Across four dose levels, all patients achieved greater than 50% target engagement after a single dose of PLN-74809. Target engagement of 50% was previously established in a Phase 1b trial as the threshold for predicted clinical anti-fibrotic effect. In addition, there was a dose- and plasma concentration-dependent response with the two highest doses approaching target saturation.

    "We believe the high target engagement levels seen after the administration of just a single dose illustrate the potential of PLN-74809 to show a potent anti-fibrotic effect in our longer-term clinical trials," said Éric Lefebvre, M.D., Chief Medical Officer of Pliant Therapeutics. "Furthermore, these data represent a significant step forward in our understanding of the potential anti-fibrotic activity of PLN-74809 and support the selected doses in our ongoing 12-week Phase 2a INTEGRIS-IPF trial."

    The ongoing Phase 2a open-label PET imaging clinical trial is designed to evaluate αvβ6 target engagement levels achieved by PLN-74809 when administered across single-doses of 60 mg, 120 mg, 240 mg or 320 mg in IPF patients. The trial is also evaluating safety, tolerability and pharmacokinetics. Patients undergo a PET scan prior to dosing and at four hours post-dose to evaluate target αvβ6 specific engagement. Images are analyzed for regions of high fibrotic activity, which are then evaluated for target engagement. Following completion of a standard washout period, patients may consent to receive a second dose of PLN-74809 at a different dose level followed by a second post-dose PET scan.

    As fibrosis is a chronic disease, proof-of-efficacy in human trials is expensive and takes years to complete. Pliant utilizes pharmacodynamic biomarkers and advanced imaging techniques, including PET, to evaluate target engagement by our product candidates over relatively short time periods and de-risk Pliant's programs by designing clinical trials that allow the Company to show proof-of-mechanism in advance of clinical efficacy data.



    Interim Phase 2a PET Clinical Trial Results

    Four IPF patients were administered six single doses of PLN-74809 across 60 mg, 120 mg, 240 mg or 320 mg, generating a total of six post-dose scans.

    PLN-74809 Demonstrated Lung Penetration, with Greater than 50% Target Engagement Achieved in the Lungs of All IPF Patients Across All Dose Cohorts

    • Up to 98% target engagement of PLN-74809 achieved
    • Greater than 50% target engagement of PLN-74809 achieved across all doses

    Dose and Plasma Concentration Response Established

    • PLN-74809 achieved a dose response across all single-doses from 60 mg to 320 mg
    • Suggests target engagement levels along the entire exposure curve of PLN-74809
    • Supports potential anti-fibrotic activity of PLN-74809 at the doses being evaluated in the ongoing Phase 2a INTEGRIS-IPF trial

    PLN-74809 Well-Tolerated Across All Doses

    • No serious adverse events reported

    Conference Call and Webcast



    Pliant will host a conference call and webcast today at 8:00 a.m. ET to discuss this update. The webcast will be available in the Events & Presentations section of Pliant's website. This update can also be accessed by dialing (833) 519-1340 (United States and Canada) or (914) 800-3902 (international) and providing the passcode 6186023. An archived reply of the webcast will be available on Pliant's website for 90 days following the event.

    About Pliant Therapeutics, Inc.

    Pliant is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrotic and related diseases. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of αvß6 and αvß1 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 for Phase 2a trials of PLN-74809 in the lead indications of IPF and 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 its development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant, 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 the pharmacodynamics and therapeutic potential of PLN-74809, our plans for the future development of PLN-74809, the potential of our Phase 2a PET trial to predict future clinical outcomes and the potential for the preliminary results of this trial to predict future results. 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 ongoing nature of our Phase 2a PET trial and the possibility that the preliminary data will not be predictive of full data from this trial, the possibility that results from this trial will not be predictive of future clinical outcomes, 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 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 June 30, 2021, 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.

    ir@pliantrx.com





    Primary Logo

    View Full Article Hide Full Article
  2. SOUTH SAN FRANCISCO, Calif., Sept. 03, 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 that the Company plans to issue a pre-market press release and conduct a conference call and webcast on Tuesday, September 7, 2021, to discuss interim clinical data from an ongoing Phase 2a positron emission tomography (PET) imaging trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF).

    The Company will host a conference call and webcast at 8:00 a.m. ET on Tuesday, September 7th to discuss this update. The link to the webcast of the conference call will be posted in the Events

    SOUTH SAN FRANCISCO, Calif., Sept. 03, 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 that the Company plans to issue a pre-market press release and conduct a conference call and webcast on Tuesday, September 7, 2021, to discuss interim clinical data from an ongoing Phase 2a positron emission tomography (PET) imaging trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF).

    The Company will host a conference call and webcast at 8:00 a.m. ET on Tuesday, September 7th to discuss this update. The link to the webcast of the conference call will be posted in the Events & Presentations section of the Company's website. The conference call may also be accessed by dialing (833) 519-1340 (domestic) or (914) 800-3902 (international) five minutes prior to the start of the call and providing the passcode 6186023. An archived replay will be accessible for 90 days following the event.

    About Pliant Therapeutics, Inc.

    Pliant is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrotic and related diseases. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of αvß6 and αvß1 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 for Phase 2a trials of PLN-74809 in the lead indications of IPF and 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 its development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant, 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.

    ir@pliantrx.com 

     



    Primary Logo

    View Full Article Hide Full Article
  3. SOUTH SAN FRANCISCO, Calif., Sept. 02, 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 participation in the following investor conferences:

    • Citi 16th Annual BioPharma Virtual Conference – Pliant's senior management team will participate in one-on-one meetings with members of the investment community September 8 - 9, 2021
    • Cantor 2021 Virtual Global Healthcare Conference – Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will present on Wednesday, September 29, 2021, at 2:40 p.m. ET / 11:40 a.m. PT and, along with members of Pliant's senior management team…

    SOUTH SAN FRANCISCO, Calif., Sept. 02, 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 participation in the following investor conferences:

    • Citi 16th Annual BioPharma Virtual Conference – Pliant's senior management team will participate in one-on-one meetings with members of the investment community September 8 - 9, 2021
    • Cantor 2021 Virtual Global Healthcare Conference – Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will present on Wednesday, September 29, 2021, at 2:40 p.m. ET / 11:40 a.m. PT and, along with members of Pliant's senior management team, will participate in one-on-one meetings with members of the investment community

    The webcast replay of the Cantor conference presentation will be archived for 90 days following the conclusion of the event.

    About Pliant Therapeutics, Inc.

    Pliant 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 and 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 its development partnership. In addition to clinical stage programs, Pliant currently has two preclinical programs targeting oncology and muscular dystrophies. For additional information about Pliant, 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.

    ir@pliantrx.com

     



    Primary Logo

    View Full Article Hide Full Article
  4. - SAD cohorts up to 640 mg and MAD cohorts up to 320 mg completed in extended Phase 1a trial of PLN-74809
    in healthy volunteers with no safety concerns identified

    - 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

    - Analysis of PLN-74809 Phase 2a PET images underway, including a 320 mg cohort,
    with preliminary data anticipated upon analysis completion

    SOUTH SAN FRANCISCO, Calif., Aug. 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 second…

    - SAD cohorts up to 640 mg and MAD cohorts up to 320 mg completed in extended Phase 1a trial of PLN-74809

    in healthy volunteers with no safety concerns identified

    - 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

    - Analysis of PLN-74809 Phase 2a PET images underway, including a 320 mg cohort,

    with preliminary data anticipated upon analysis completion

    SOUTH SAN FRANCISCO, Calif., Aug. 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 second quarter 2021 financial results.

    "Driven by our progress throughout the second quarter, enrollment continues to be on track for our Phase 2a trials of PLN-74809 in IPF and PSC with strong advancement in our development stage oncology and DMD programs," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "PLN-74809 continues to demonstrate a favorable safety profile as additional dose cohorts from the single and multiple ascending dose Phase 1a trial show PLN-74809 to be generally well tolerated at all dose levels tested, with a predictable pharmacokinetic profile similar to previous dose cohorts."

    Second Quarter and Recent Highlights

    • Single ascending dose (SAD) cohorts up to 640mg and multiple ascending dose (MAD) cohorts up to 320mg completed in extended Phase 1a dose escalation trial of PLN-74809 in healthy volunteers. PLN-74809 has completed dosing of additional SAD cohorts of up to 640 mg and MAD cohorts of up to 320 mg once daily dose in an extended dose escalation trial. The pharmacokinetic profile remains generally dose proportional with PLN-74809 continuing to be generally well tolerated, with no severe adverse events or serious adverse events reported.



    • Enrollment on track for PLN-74809 Phase 2a trial in idiopathic pulmonary fibrosis (IPF). INTEGRIS-IPF is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 in IPF patients. This trial is evaluating exploratory endpoints including quantitative lung fibrosis score, or QLF, imaging as well as pulmonary function tests. Enrollment is currently on track to be completed by the end of 2021.



    • Enrollment on track for PLN-74809 Phase 2a trial in primary sclerosing cholangitis (PSC). INTEGRIS-PSC is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 in PSC patients. The trial is evaluating exploratory endpoints including fibrosis biomarkers such as Pro-C3 and ELF, changes in ALP, and liver imaging. Enrollment is currently on track to be completed in the first half of 2022.



    • Image analysis from PLN-74809 Phase 2a positron emission tomography (PET) trial underway, including addition of a 320 mg cohort, with preliminary data anticipated upon completion of the analysis. This open-label, dose ranging trial is evaluating target receptor occupancy levels of PLN-74809 in the lungs of IPF patients across ascending single-dose cohorts, utilizing a PET tracer of the integrin αvβ6. The Company recently amended the protocol to increase the maximum dose to 320 mg. In the second quarter, the first patients were dosed in this cohort.



    • Preclinical stage integrin-based programs continue to progress. The Company's early-stage programs targeting oncology and muscular dystrophies continue to advance toward the clinic. The oncology program is focused on increasing tumor checkpoint sensitivity through small molecule inhibition of αvβ8. The muscular dystrophy program is focused on improving muscle function through activation of an integrin compensatory mechanism with a monoclonal antibody.



    • Resources redeployed in support of ongoing PLN-74809 Phase 2a trials in IPF and PSC. Despite the rise of recently identified COVID-19 variants, the broad availability of vaccines, as well as the increased and successful measures taken over the past nine months to contain the virus have resulted in a dramatic decrease in the number of severe and critical COVID-19 patients with acute respiratory distress syndrome (ARDS). Given the declining number of addressable patients, the Company has discontinued enrollment in the PLN-74809 Phase 2a COVID-19-related ARDS trial allowing for resources to be directed toward our lead indications.

    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.  

    Second Quarter 2021 Financial Results

    • Research and development expenses were $19.2 million, as compared to $17.5 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 $5.5 million, as compared to $3.0 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
    • Net loss of $22.8 million as compared to $17.0 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 June 30, 2021, the Company had cash, cash equivalents and short-term investments of $244.0 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. 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 Twitter, LinkedIn, Facebook 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 the anticipated progress of our clinical trials and timing of enrollment and data disclosures, the potential future impact of the COVID-19 pandemic and expectations regarding how far into the future our cash on hand will fund our operating and capital requirements. 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 Annual Report on Form 10-K filed with the SEC on March 16, 2021, as updated by our Quarterly Report on Form 10-Q filed with the SEC on May 10, 2021 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 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.

    IR@pliantrx.com



    Pliant Therapeutics, Inc.

    Condensed Statements of Operations

    (Unaudited)

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

     Three Months Ended

    June 30,
     2021 2020
    Revenue — related party$1,789   $3,600  
    Operating expenses:   
    Research and development(19,218)  (17,536) 
    General and administrative(5,475)  (3,040) 
    Total operating expenses(24,693)  (20,576) 
    Loss from operations(22,904)  (16,976) 
    Interest and other income (expense), net73   (25) 
    Net income loss$(22,831)  $(17,001) 
    Less: Undistributed earnings to preferred shareholders     
    Net loss attributable to common stockholders$(22,831)  $(17,001) 
    Net loss per share, attributable to common stockholders:   
    Basic$(0.64)  $(1.39) 
    Diluted$(0.64)  $(1.39) 
    Shares used in computing net loss per share attributable to common stockholders:   
    Basic35,746,922   12,253,943  
    Diluted35,746,922   12,253,943  
    Comprehensive income loss:   
    Net loss$(22,831)  $(17,001) 
    Net unrealized loss on short-term investments$(12)  $(89) 
    Total other comprehensive loss(12)  (89) 
    Comprehensive loss$(22,843)  $(17,090) 
              

    Pliant Therapeutics, Inc.

    Condensed Balance Sheets

    (Unaudited)

    (In thousands)

     June 30,

    2021
     December 31,

    2020
    Assets   
    Current assets   
    Cash and cash equivalents$35,193   $50,882  
    Short-term investments208,788   226,012  
    Accounts receivable1,830   9,279  
    Tax credit receivable83   83  
    Prepaid expenses and other current assets4,825   4,498  
    Total current assets250,719   290,754  
    Property and equipment, net4,367   4,321  
    Other non-current assets630   451  
    Total assets$255,716   $295,526  
    Liabilities and Stockholders' Equity   
    Current liabilities   
    Accounts payable$2,764   $2,023  
    Accrued liabilities8,168   9,576  
    Total current liabilities10,932   11,599  
    Other long-term liabilities804   866  
    Total liabilities11,736   12,465  
    Stockholders' equity   
    Common stock3   3  
    Additional paid-in capital407,522   400,918  
    Accumulated deficit(163,515)  (117,828) 
    Accumulated other comprehensive loss(30)  (32) 
    Total stockholders' equity243,980   283,061  
    Total liabilities and stockholders' equity$255,716   $295,526  
        


    Primary Logo

    View Full Article Hide Full Article
  5. SOUTH SAN FRANCISCO, Calif., Aug. 03, 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 BTIG Virtual Biotechnology Conference to be held August 9 – 10, 2021.

    Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in a fireside chat on Tuesday, August 10, 2021, at 3:30 p.m. EST / 12:30 p.m. PST and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    About Pliant Therapeutics, Inc.

    Pliant Therapeutics is a clinical stage biopharmaceutical…

    SOUTH SAN FRANCISCO, Calif., Aug. 03, 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 BTIG Virtual Biotechnology Conference to be held August 9 – 10, 2021.

    Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in a fireside chat on Tuesday, August 10, 2021, at 3:30 p.m. EST / 12:30 p.m. PST and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    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.

    ir@pliantrx.com

     



    Primary Logo

    View Full Article Hide Full Article
  6. - 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.

    ir@pliantrx.com



    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 


    Primary Logo

    View Full Article Hide Full Article
  7. 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.

    ir@pliantrx.com



    Primary Logo

    View Full Article Hide Full Article
  8. 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.

    ir@pliantrx.com





    Primary Logo

    View Full Article Hide Full Article
  9. - 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.

    ir@pliantrx.com

    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 
             

     



    Primary Logo

    View Full Article Hide Full Article
  10. 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.

    ir@pliantrx.com



    Primary Logo

    View Full Article Hide Full Article
  11. SOUTH SAN FRANCISCO, Calif., Feb. 18, 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 that management will be participating in the following virtual investor events in March:

    • Cowen 41st Annual Health Care Conference – March 1-4, 2021. Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in the Respiratory/Infections Panel discussion on March 1, 2021 at 10:30 a.m. ET/ 7:30 a.m. PT and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    The Cowen Respiratory/Infections…

    SOUTH SAN FRANCISCO, Calif., Feb. 18, 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 that management will be participating in the following virtual investor events in March:

    • Cowen 41st Annual Health Care Conference – March 1-4, 2021. Bernard Coulie, M.D., Ph.D., Pliant's President and Chief Executive Officer, will participate in the Respiratory/Infections Panel discussion on March 1, 2021 at 10:30 a.m. ET/ 7:30 a.m. PT and, along with members of Pliant's senior management team, will conduct one-on-one meetings with members of the investment community.

    The Cowen Respiratory/Infections Panel will stream live and have a replay available on Cowen's Conference Site.

    • Citi's 2021 Winter West Coast Biotech Virtual Bus Tour - March 16-17, 2021. Pliant senior management will be meeting with investors on March 17, 2021.

    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 TwitterLinkedIn, Facebook, and YouTube.

    Investor and Media Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.

    ir@pliantrx.com



    Primary Logo

    View Full Article Hide Full Article
  12. SOUTH SAN FRANCISCO, Calif., Jan. 12, 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 appointment of Dr. David Pyott, former Chairman and Chief Executive Officer of Allergan, to Pliant's Board of Directors.  

    "David is an accomplished international pharmaceutical executive whose extensive experience in building companies will be invaluable at this stage of Pliant's development," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "It is my great pleasure to welcome David to the Board and look forward to his insights as we advance and expand our…

    SOUTH SAN FRANCISCO, Calif., Jan. 12, 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 appointment of Dr. David Pyott, former Chairman and Chief Executive Officer of Allergan, to Pliant's Board of Directors.  

    "David is an accomplished international pharmaceutical executive whose extensive experience in building companies will be invaluable at this stage of Pliant's development," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant. "It is my great pleasure to welcome David to the Board and look forward to his insights as we advance and expand our clinical stage portfolio."

    Dr. Pyott joins the Pliant Board of Directors with more than 30 years of executive leadership and management experience within the global pharmaceutical industry. Dr. Pyott most recently served as Chairman and Chief Executive Offer of Allergan, where, over his 17-year tenure in this role, he transformed the company from a small eye care business with $1 billion in annual sales into a global specialty pharmaceutical and medical device company with 2014 annual sales of over $7 billion. Prior to Allergan, Dr. Pyott held the role of Head of the Novartis Nutrition Division and served as a member of the Executive Committee of Switzerland-based Novartis AG.

    "I am excited to be joining the Pliant board and supporting an accomplished group of board members and a strong leadership team to help guide the company's mission of delivering innovative and potential transformative treatments to patients," said Dr. Pyott. "I believe Pliant's novel approach has the potential to address the need for new treatments for fibrotic diseases."

    In addition to Pliant, Dr. Pyott currently serves as a member of the Board of Directors of Alnylam Pharmaceuticals and BioMarin Pharmaceutical, as Chairman of Bioniz Therapeutics, Inc., a private biotechnology company, and is a member of the Supervisory Board of Royal Philips in the Netherlands, a public diversified health technology company. Dr. Pyott serves as Deputy Chairman of the Governing Board of the London Business School, President of the Ophthalmology Foundation, President of the Advisory Board of the American Academy of Ophthalmology and is also a Trustee of the California Institute of Technology.

    Dr. Pyott holds a Diploma in International and European Law from the Europa Institute at the University of Amsterdam, an Honorary Degree in Medicine and a Master of Arts degree from the University of Edinburgh, and a Master of Business Administration degree from the London Business School.

    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 TwitterLinkedIn, and Facebook.

    Investor Contact:

    Christopher Keenan

    Vice President, Investor Relations and Corporate Communications

    Pliant Therapeutics, Inc.

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria.fuqua@canalecomm.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/95826a4d-80dc-482a-aab1-c8684bfa48e5



    Primary Logo

    View Full Article Hide Full Article
  13. SOUTH SAN FRANCISCO, Calif., Jan. 04, 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 appointment of Gregory P. Cosgrove, M.D., FCCP, as Pliant's Vice President of Clinical Development. Dr. Cosgrove brings over 20 years of pulmonary and critical care expertise in academic clinical research to Pliant and in this role, will lead the strategic execution of the company's Idiopathic Pulmonary Fibrosis (IPF) clinical development program with its lead compound PLN-74809. PLN-74809 is a dual selective inhibitor of αvβ6/αvβ1, in clinical development for the treatment of IPF, primary sclerosing…

    SOUTH SAN FRANCISCO, Calif., Jan. 04, 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 appointment of Gregory P. Cosgrove, M.D., FCCP, as Pliant's Vice President of Clinical Development. Dr. Cosgrove brings over 20 years of pulmonary and critical care expertise in academic clinical research to Pliant and in this role, will lead the strategic execution of the company's Idiopathic Pulmonary Fibrosis (IPF) clinical development program with its lead compound PLN-74809. PLN-74809 is a dual selective inhibitor of αvβ6/αvβ1, in clinical development for the treatment of IPF, primary sclerosing cholangitis (PSC), and COVID-19-associated acute respiratory distress syndrome (ARDS).

    "Greg's extensive scientific and clinical expertise in the area of pulmonary fibrosis, as well as his strong relationships within the research, clinical investigator, and patient communities, will be instrumental as we further implement the development strategy of our novel IPF program," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "I look forward to working with Greg and utilizing his broad experiences to enhance our clinical development efforts and support the progress of PLN-74809."

    Dr. Cosgrove most recently served as the Chief Medical Officer of the Pulmonary Fibrosis Foundation, a leading nonprofit organization dedicated to assisting patients and identifying effective treatments and a cure for those living with pulmonary fibrosis. Concurrently, Dr. Cosgrove also held the roles of Associate Professor within the pulmonology divisions of the University of Colorado-Denver and National Jewish Health Departments of Medicine. Dr. Cosgrove has served as principal or sub investigator in more than 15 clinical trials evaluating IPF drug candidates, authored or contributed to over 70 publications and books in pulmonology research, and served as a reviewer for numerous scientific peer-reviewed journals.

    Dr. Cosgrove commented, "As a physician, researcher and advocate, I believe patients are a cornerstone to changing the landscape in pulmonary fibrosis. I am excited to join a team that shares my commitment to the patient and to advancing treatments for IPF and other fibrotic diseases."

    Dr. Cosgrove received his B.S., magna cum laude, from James Madison University with highest honors in chemistry and his M.D. from the Hahnemann University School of Medicine in Philadelphia. Dr. Cosgrove completed his residency in internal medicine and post-doctoral fellowships at the University of Colorado Health Sciences Center Denver and the National Jewish Medical and Research Center Denver, respectively.

    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.

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria.fuqua@canalecomm.com

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d92466b0-df39-4775-b95e-17fc5f8190ad.



    Primary Logo

    View Full Article Hide Full Article
  14. 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.

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria.fuqua@canalecomm.com

    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.

    View Full Article Hide Full Article
  15. 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.

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria.fuqua@canalecomm.com

     

    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.

    View Full Article Hide Full Article
  16. 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:ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria.fuqua@canalecomm.com

     

    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.

    View Full Article Hide Full Article
  17. 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:

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    (619) 849-5390

    cambria.fuqua@canalecomm.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-appoints-mike-ouimette-as-general-counsel-301145406.html

    SOURCE Pliant Therapeutics, Inc.

    View Full Article Hide Full Article
  18. 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:

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria@canalecomm.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-presents-data-at-american-thoracic-society-2020-virtual-sessions-301137180.html

    SOURCE Pliant Therapeutics, Inc.

    View Full Article Hide Full Article
  19. SOUTH SAN FRANCISCO, Calif., Sept. 4, 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 that management will be participating in the following investor conferences in September 2020:

    • Citi's 15th Annual BioPharma Conference on September 8-11, 2020. Pliant's Scott Turner, Ph.D., will be on a panel discussing COVID-19 therapeutics on Wednesday, September 9 at 9:50 a.m. EDT.
    • Cantor Fitzgerald's Virtual Global Healthcare Conference on September 15-17, 2020.

    Company presentations and webcast replays will be available directly on the conference event platform or the Pliant Therapeutics Investors page: https://ir.pliantrx.com/events-and-presentations.

    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:

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria@canalecomm.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-to-participate-in-upcoming-virtual-investor-conferences-301124274.html

    SOURCE Pliant Therapeutics, Inc.

    View Full Article Hide Full Article
  20. SAN FRANCISCO, Aug. 27, 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 that the company will be presenting data at The Digital International Liver Congress™ (ILC) 2020. Pliant is evaluating PLN-74809 in fibrotic diseases with high unmet medical need, including idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC).

    "Our research, to date, has generated encouraging evidence supporting the rationale for directly targeting the TGF-β activation pathway via integrin inhibition in fibrotic diseases," said Éric Lefebvre, M.D., chief medical officer of Pliant Therapeutics. "We believe this novel approach could potentially provide meaningful antifibrotic benefits in patients with chronic liver diseases including PSC and NASH."

    Details for both the oral presentation and poster at The Digital ILC 2020 are as follows:

    Oral Presentation Title: PLN-74809, a clinical stage, dual αvβ6 αvβ1 integrin inhibitor, reduces fibrosis in a preclinical model of biliary fibrosis and precision cut liver slices from primary sclerosing cholangitis and primary biliary cholangitis patients (AS-144)

    Date & Time: Thursday, August 27, 2020, 12:15 p.m.12:30 p.m. CEST

    Session: Liver Fibrosis

    Poster Title: Reduction in types I and III collagen gene expression by an αvβ1 integrin inhibitor correlates with a decrease in PRO-C1 and PRO-C3 levels in precision-cut liver tissue slices

    from cirrhotic nonalcoholic steatohepatitis patients (FRI-237)

    Date & Time:  Friday, August 28, 2020, 9:30 a.m. - 19:30 p.m. CEST

    Session: Fibrosis

    Both presentations will be available to registered participants via the ILC 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:

    ir@pliantrx.com  

    Media Contact:

    Cambria Fuqua

    Canale Communications

    (619) 849-5390

    cambria@canalecomm.com  

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-presents-data-at-the-digital-international-liver-congress-2020-301119349.html

    SOURCE Pliant Therapeutics, Inc.

    View Full Article Hide Full Article
  21. SOUTH SAN FRANCISCO, Calif., Aug. 11, 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 provided a corporate update and reported second-quarter 2020 financial results.

    "2020 has been a productive year as we've made progress on multiple fronts, including the initiation of a 12-week Phase 2a clinical trial evaluating PLN-74809 in patients with idiopathic pulmonary fibrosis, as well as dosing initial cohorts in our first-in-human trial of our Novartis partnered program, PLN-1474, for the potential treatment of liver fibrosis," said Bernard Coulie, M.D., Ph.D., chief executive officer and president of Pliant Therapeutics. "Bolstered by a strong cash position from our Series C financing in February and our IPO in June, we continue to advance our robust pipeline. We're now focused on executing our Phase 2a program for PLN-74809 and look forward to sharing further updates on all of our programs."

    Recent Highlights

    • Completed an initial public offering (IPO) and concurrent private placement with Novartis. The IPO priced at $16.00 per share, generating gross proceeds of $165.6 million including shares sold to the underwriters pursuant to the full exercise of their overallotment option before deducting underwriting discounts, commissions and other offering expenses payable by Pliant. The company also received $10.0 million in additional proceeds from a concurrent private placement with Novartis Institutes for BioMedical Research, Inc. at the public offering price of $16.00 per share. The Company's common stock commenced trading on the Nasdaq Global Select Market under the ticker symbol "PLRX" on June 3rd, 2020.
    • Phase 2a 12-week trials of PLN-74809 in idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) have resumed enrollment. Through close coordination with over 100 global trial sites, Pliant has continued to conduct site initiation activities throughout the COVID-19 pandemic. The Company is offering a hybrid approach to clinical trial participation with home-health solutions designed to minimize the requirements for visits to healthcare facilities, as well as a campaign to raise awareness of the IPF and PSC programs across patient communities and patient advocacy groups. Phase 2a clinical trial sites are currently enrolling patients in both the IPF and PSC trials.
    • Opened Investigational New Drug (IND) Application for PLN-74809 for treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19. Pliant submitted the COVID-19 ARDS IND in June and the FDA has since issued a "safe to proceed" letter. The Company plans to initiate a Phase 2 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 in the second half of 2020. This represents the fourth IND that Pliant has successfully opened since operations began in 2016.
    • Completed dosing of initial cohorts of a Phase 1 trial of PLN-1474. 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. The Phase 1 trial site has experienced delays due to COVID-19; however, it is now open and expected to continue dosing the remaining cohorts with topline data expected in the first quarter of 2021, subject to further impact of the COVID-19 pandemic. PLN-1474 is partnered with Novartis.

    COVID-19 Preparedness

    Pliant has worked proactively to establish policies and procedures to enable the Company to operate safely and productively during the pandemic. The Company has experienced delays in clinical trial operations which will impact the expected timing of data readouts, but is working closely with clinical sites to continue site initiation activities in compliance with study protocols while observing government and institutional guidelines. The clinical site conducting Pliant's Phase 2a PET trial of PLN-74809 in IPF remains closed to clinical research, but expects to resume trial activities in the third quarter. Pliant has made significant progress in opening trial sites for its Phase 2a 12-week IPF and PSC trials by offering a hybrid approach to clinical trial participation with home-health solutions designed to minimize the requirements for visits to healthcare facilities, as well as a campaign to raise awareness of the IPF and PSC programs across patient communities and patient advocacy groups. The Company intends to provide more specific guidance regarding clinical trial progress and the timing of data readouts as the impacts of the pandemic are better understood.

    Second-Quarter 2020 Financial Results

    • Related party revenue was $3.6 million as compared to nil for the prior-year period.
    • Research and development expenses were $17.5 million, as compared to $13.1 million for the prior-year period. The increase was primarily related to higher external research and development expenses associated with the advancement of several programs and ongoing Phase 2 clinical trials.
    • General and administrative expenses were $3.0 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 $17.0 million as compared to a net loss of $15.5 million for the prior-year period.
    • As of June 30, 2020, Pliant had cash, cash equivalents and short-term investments of $312.5 million, compared to $102.8 million as of December 31, 2019. 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.

    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, which is 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 June 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:

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    cambria@canalecomm.com

    Pliant Therapeutics, Inc.

    Condensed Statements of Operations and Comprehensive Loss

    (Unaudited)

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







    Three Months Ended

    June 30,





    Six Months Ended

    June 30,







    2020





    2019





    2020





    2019



    Revenue — related party



    $

    3,600





    $





    $

    32,538





    $



    Operating expenses:

































    Research and development





    (17,536)







    (13,098)







    (31,455)







    (24,847)



    General and administrative





    (3,040)







    (2,643)







    (7,051)







    (5,244)



    Total operating expenses





    (20,576)







    (15,741)







    (38,506)







    (30,091)



    Loss from operations





    (16,976)







    (15,741)







    (5,968)







    (30,091)



    Interest income





    111







    240







    320







    553



    Other expense, net





    (136)







    (21)







    (324)







    (7)



    Net loss



    $

    (17,001)





    $

    (15,522)





    $

    (5,972)





    $

    (29,545)



    Accretion to redemption value and cumulative dividends on

       redeemable convertible preferred stock











    (1,359)













    (2,703)



    Net loss attributable to common stockholders



    $

    (17,001)





    $

    (16,881)





    $

    (5,972)





    $

    (32,248)



    Net loss per share, attributable to common stockholders:

































    Basic



    $

    (1.39)





    $

    (10.82)





    $

    (0.85)





    $

    (21.70)



    Diluted



    $

    (1.39)





    $

    (10.82)





    $

    (0.85)





    $

    (21.70)



    Shares used in computing net loss per share attributable

       to common stockholders:

































    Basic





    12,253,943







    1,559,942







    7,062,780







    1,486,109



    Diluted





    12,253,943







    1,559,942







    7,062,780







    1,486,109



    Comprehensive loss:

































    Net loss



    $

    (17,001)





    $

    (15,522)





    $

    (5,972)





    $

    (29,545)



    Net unrealized (loss) gain on short-term investments



    $

    (89)





    $

    8





    $

    (29)





    $

    11



    Total other comprehensive (loss) income





    (89)







    8







    (29)







    11



    Comprehensive loss



    $

    (17,090)





    $

    (15,514)





    $

    (6,001)





    $

    (29,534)



     

    Pliant Therapeutics, Inc.

    Condensed Balance Sheets

    (Unaudited)

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







    June 30,

    2020





    December 31,

    2019



    Assets

















    Current assets

















    Cash and cash equivalents



    $

    178,461





    $

    85,807



    Short-term investments





    134,007







    16,966



    Accounts receivable





    3,599







    7,052



    Tax credit receivable





    83







    333



    Prepaid expenses and other current assets





    8,173







    1,742



    Total current assets





    324,323







    111,900



    Property and equipment, net





    4,029







    4,079



    Other non-current assets





    451







    3,085



    Total assets



    $

    328,803





    $

    119,064



    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)

















    Current liabilities

















    Accounts payable



    $

    2,483





    $

    1,250



    Accrued liabilities (Note 5)





    9,553







    6,922



    Total current liabilities





    12,036







    8,172



    Other long-term liabilities (Note 5)





    951







    912



    Total liabilities





    12,987







    9,084



    Commitments and Contingencies (Note 13)

















    Preferred stock, $0.0001 par value; 10,000,000 shares and 0 shares authorized at June 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding at June 30, 2020 and December 31, 2019;













    Series A redeemable convertible preferred stock, $0.0001 par value; 0 and 56,000,000 shares authorized at June 30, 2020 and December 31, 2019, respectively; 0 and 56,000,000 shares issued and outstanding, at June 30, 2020 and December 31, 2019, respectively; aggregate liquidation preference of $0 and $62,468 at June 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 June 30, 2020 and December 31, 2019, respectively; 0 shares and 49,501,221 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively; aggregate liquidation preference of $0 and $75,860 at June 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 June 30, 2020 and December 31, 2019, respectively; 0 shares and 26,360,745 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively; aggregate liquidation preference of $0 and $47,947 at June 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 June 30, 2020 and December 31, 2019; and 35,427,199 and 1,846,024 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively;





    3







    1



    Additional paid-in capital





    398,110









    Accumulated deficit





    (82,267)







    (76,295)



    Accumulated other comprehensive loss





    (30)







    (1)



    Total stockholders' equity (deficit)





    315,816







    (76,295)



    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)



    $

    328,803





    $

    119,064



     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-provides-corporate-update-and-announces-second-quarter-2020-financial-results-301110312.html

    SOURCE Pliant Therapeutics, Inc.

    View Full Article Hide Full Article
  22. Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, followed by Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) on Friday. Other companies mentioned – Emmaus Life Sciences (OTCQB:EMMA)

    DENVER, Colo. – June 8, 2020 – The biotech IPO calendar kicked off last week when Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, after pricing its initial public offering at $16 per share. All trading action, during the 3 sessions, has taken place between $21 and $26. The clinical stage biopharmaceutical company sold 9 million shares, 50% more than initial plan to issue just 6 million shares, to raise $144 million.

    The week ended with Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) (AMT…

    Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, followed by Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) on Friday. Other companies mentioned – Emmaus Life Sciences (OTCQB:EMMA)

    DENVER, Colo. – June 8, 2020 – The biotech IPO calendar kicked off last week when Pliant Therapeutics (NASDAQ:PLRX) began trading Wednesday, after pricing its initial public offering at $16 per share. All trading action, during the 3 sessions, has taken place between $21 and $26. The clinical stage biopharmaceutical company sold 9 million shares, 50% more than initial plan to issue just 6 million shares, to raise $144 million.

    The week ended with Legend Biotech (NASDAQ:LEGN) and Applied Molecular Transport (NASDAQ:AMTI) (AMT) exceeding their initial pricing expectations.

    Legend Biotech priced its initial public offering, of 18,425,000 American depositary shares (ADSs), each representing two ordinary shares, at $23.00 per ADS, for total gross proceeds of approximately $424 million. The global clinical-stage biopharmaceutical company, which is engaged in the discovery and development of novel cell therapies for oncology and other indications, traded between $35-40 on Friday and granted the underwriters a 30-day option to purchase up to an additional 2,763,750 ADSs at the public offering price, less underwriting discounts and commissions.

    AMT expects to raise $154 million, less the underwriting discounts and commissions, for the 11 million Class A shares offered on Friday. The clinical-stage biopharmaceutical company traded between $26 and $17.15, after pricing of its common stock at $14.00 per share. Additionally, AMT granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of common stock at the initial public offering price, less fees.

    Emmaus Life Sciences (OTCQB:EMMA) (ELS), a leader in sickle cell anemia disease treatment, which didn’t IPO last week, continues to build on its recent operational updates, closed Friday’s session at $ 1.60 on just over 10,000 shares.

    ELS switched from a contract sales organization to its own direct sales force, which started on January 1, 2020, and continues to build its internal sales and marketing capabilities. In the first quarter of 2020, Emmaus increased sales by 10% over the preceding quarter and 39% over the same quarter of the prior year.

    Connect with 24/7 Market News on social media

    https://twitter.com/247MarketNewsHQ

    https://www.facebook.com/247MarketNewsHQ/

    About 24/7 Market News

    As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information.  24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community.

    DISCLAIMER:

    24/7 Market News (24/7MN) is a third party publisher and news dissemination service provider that produces regular sponsored and non-sponsored reports, articles, stock market blogs, and newsletters covering equities listed on the NYSE, NASDAQ and micro-cap exchanges. 24/7MN holds no investment licenses and is NOT a financial advisory firm, investment adviser, analyst, or broker-dealer and does not undertake any activities that would require such registration. 24/7MN’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities.

    Materials in this release are informational and should never be considered research. You must do your own due diligence by reading all available public information. This release is a corporate public statement, and believed to be reliable. The principle and editor of 24/7 currently owns no shares of the aforementioned companies, but has the right to buy and sell at any time of his choosing which could be viewed as a conflict of interest. 24/7 makes no representations and warranties to the completeness of materials provided and are subject to change without notice. 24/7 is not responsible for any gains or losses which result from our opinions or coverage expressed in our emails or our site and readers are cautioned that investing has risks and you may lose all or a portion of your money.

    For further information on 24/7 Market News, please go to www.247marketnews.com 

    Cautionary Statement Regarding Forward Looking Information

    Statements in this press release about the Company’s future and expectations other than historical facts are “forward-looking statements.” These statements are made on the basis of management’s current views and assumptions. As a result, there can be no assurance that management’s expectations will necessarily come to pass. These forward-looking statements generally can be identified by phrases such as “believes,” “plans,” “expects,” “anticipates,” “foresees,” “estimated,” “hopes,” “if,” “develops,” “researching,” “research,” “pilot,” “potential,” “could” or other words or phrases of similar import. Forward looking statements include descriptions of the Company’s business strategy, outlook, objectives, plans, intentions and goals. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security.

    CONTACT:

    24/7 Market News

    Editor@247marketnews.com

    Media Contact
    Company Name: 24/7 Market News
    Contact Person: Editor
    Email: Send Email
    Phone: 720.989.9923
    Country: United States
    Website: https://www.247marketnews.com/

     

    Press Release Distributed by ABNewswire.com

    To view the original version on ABNewswire visit: 24/7 Market News – Keep an eye on last week's Biotech IPOs

    View Full Article Hide Full Article
  23. SOUTH SAN FRANCISCO, Calif., June 5, 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 the closing of its initial public offering of 10,350,000 shares of common stock, which includes the exercise in full by the underwriters of their 30-day option to purchase up to an additional 1,350,000 shares of common stock, at a public offering price of $16.00 per share. The aggregate gross proceeds to Pliant from the initial public offering were approximately $165.6 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares of common stock were offered…

    SOUTH SAN FRANCISCO, Calif., June 5, 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 the closing of its initial public offering of 10,350,000 shares of common stock, which includes the exercise in full by the underwriters of their 30-day option to purchase up to an additional 1,350,000 shares of common stock, at a public offering price of $16.00 per share. The aggregate gross proceeds to Pliant from the initial public offering were approximately $165.6 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares of common stock were offered by Pliant. The shares began trading on The Nasdaq Global Select Market on June 3, 2020, under the ticker symbol "PLRX."

    Citigroup, Cowen and Piper Sandler acted as joint book-running managers for the initial public offering. Needham & Company acted as lead manager for the offering. 

    A registration statement on Form S-1 relating to shares of common stock sold in the initial public offering has been filed with the Securities and Exchange Commission and became effective on June 2, 2020. The initial public offering was made only by means of a final prospectus, copies of which may be obtained, when available, from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, by telephone at (800) 747-3924, or by e-mail at prospectus@psc.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Pliant Therapeutics

    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 two Phase 2a trials of PLN-74809 for the treatment of IPF and plans to initiate a Phase 2a trial in PSC in the second half of 2020.  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

    This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements.

    Any forward-looking statements in this press release are based on Pliant's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, completion of the proposed public offering on the anticipated terms, or at all, market conditions and the satisfaction of customary closing conditions related to the initial public offering and the concurrent private placement. These and other risks concerning Pliant's programs and operations are described in additional detail in its final prospectus for the initial public offering, which is on file with the SEC. Pliant explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

    Investor Contact:

    Keith Cummings, Chief Financial Officer

    Pliant Therapeutics

    ir@pliantrx.com

    Media Contact:

    Cambria Fuqua

    Canale Communications

    (619) 849-5390

    cambria@canalecomm.com

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/pliant-therapeutics-announces-closing-of-initial-public-offering-and-full-exercise-of-option-to-purchase-additional-shares-301071484.html

    SOURCE Pliant Therapeutics, Inc.

    View Full Article Hide Full Article