About Us | ScientistPLRX Pliant Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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PLN-74809
Idiopathic pulmonary fibrosis
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Phase 2a
Phase 2a
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Phase 2a trial to complete enrollment by end of 2021.
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PLN-74809
Primary sclerosing cholangitis
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Phase 2a
Phase 2a
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Phase 2a trial to complete enrollment 1H 2022.
|
|
PLN-1474
Liver fibrosis associated with NASH
|
Phase 1
Phase 1
|
Phase 1 trial has completed - well tolerated with no dose- or treatment-limiting toxicities or severe/serious adverse events observed.
|
Latest News
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- 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 αvβ6/αvβ1, 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 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 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.
[email protected]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), net 63 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: Basic 35,645,205 1,897,669 Diluted 35,645,205 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 income 14 60 Comprehensive income (loss) $ (22,842 ) $ 11,089 Pliant Therapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(In thousands)March 31,
2021December 31,
2020Assets Current assets Cash and cash equivalents $ 50,819 $ 50,882 Short-term investments 213,281 226,012 Accounts receivable 2,174 9,279 Tax credit receivable 83 83 Prepaid expenses and other current assets 4,180 4,498 Total current assets 270,537 290,754 Property and equipment, net 4,266 4,321 Other non-current assets 451 451 Total assets $ 275,254 $ 295,526 Liabilities and Stockholders' Equity Current liabilities Accounts payable $ 2,886 $ 2,023 Accrued liabilities 7,364 9,576 Total current liabilities 10,250 11,599 Other long-term liabilities 835 866 Total liabilities 11,085 12,465 Stockholders' equity Common stock 3 3 Additional paid-in capital 404,868 400,918 Accumulated deficit (140,684 ) (117,828 ) Accumulated other comprehensive loss (18 ) (32 ) Total stockholders' equity 264,169 283,061 Total liabilities and stockholders' equity $ 275,254 $ 295,526 
- 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 αvβ6/αvβ1, 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.
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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 Twitter, LinkedIn, Facebook, and YouTube.
Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
[email protected] -
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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 Twitter, LinkedIn, Facebook, and YouTube.Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
[email protected] -
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- 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 αvβ6/αvβ1, 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 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 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.
[email protected]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,
2020December 31,
2019Assets 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 - 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 αvβ6/αvβ1, across multiple single-dose cohorts.
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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 Twitter, LinkedIn, Facebook, and YouTube.Investor and Media Contact:
Christopher Keenan
Vice President, Investor Relations and Corporate Communications
Pliant Therapeutics, Inc.
[email protected]