1. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in two virtual investor conferences being webcast in September:

    • H.C. Wainwright 23rd Annual Global Investment Conference: One-on-One Meetings on September 13, 2021, with a Corporate Presentation available to view beginning September 13, 2021
    • Baird 2021 Virtual Global Healthcare Conference: One-on-One Meetings and a Fireside Chat at 12:15 p.m. ET on September 14, 2021

    A live webcast of each event will be accessible by visiting the "Events and Presentations" section on the "Investors…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in two virtual investor conferences being webcast in September:

    • H.C. Wainwright 23rd Annual Global Investment Conference: One-on-One Meetings on September 13, 2021, with a Corporate Presentation available to view beginning September 13, 2021
    • Baird 2021 Virtual Global Healthcare Conference: One-on-One Meetings and a Fireside Chat at 12:15 p.m. ET on September 14, 2021

    A live webcast of each event will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. Replays of the webcasts will be available following the presentations and will be archived for at least 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV), non-alcoholic steatohepatitis (NASH) and SARS-CoV-2 (COVID-19). Enanta is also conducting research in human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  2. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the election of Yujiro S. Hata, to its Board of Directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210823005010/en/

    Yujiro S. Hata, Board of Directors, Enanta Pharmaceuticals (Photo: Business Wire)

    Yujiro S. Hata, Board of Directors, Enanta Pharmaceuticals (Photo: Business Wire)

    "We are thrilled to welcome Yujiro Hata to our Board of Directors," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "His depth of expertise in business and corporate development, as well as his experience as a senior executive and an independent director of several…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the election of Yujiro S. Hata, to its Board of Directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210823005010/en/

    Yujiro S. Hata, Board of Directors, Enanta Pharmaceuticals (Photo: Business Wire)

    Yujiro S. Hata, Board of Directors, Enanta Pharmaceuticals (Photo: Business Wire)

    "We are thrilled to welcome Yujiro Hata to our Board of Directors," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "His depth of expertise in business and corporate development, as well as his experience as a senior executive and an independent director of several public and private biotechnology companies, will bring complementary depth to our Board. Yujiro's insights will be particularly valuable as we continue to explore combination therapies to advance our clinical pipeline in key therapeutic areas."

    "I am delighted to join Enanta as a member of its Board of Directors. Enanta's proven, chemistry-driven approach to creating best-in-class small molecule drugs has allowed the company to develop a strong, differentiated portfolio of product candidates across virology and liver disease areas," commented Mr. Hata. "I look forward to working with the team, especially in the upcoming year, when the combination of clinical data readouts in respiratory syncytial virus, hepatitis B virus, SARS-CoV-2 and non-alcoholic steatohepatitis has the potential to be truly transformative."

    Mr. Hata has more than 20 years of experience building companies that have developed innovative therapies. He currently serves as the Founder and CEO of IDEAYA Biosciences, an oncology-focused precision medicine company, which he founded in 2015. Under his leadership, IDEAYA formed a global partnership with GlaxoSmithKline to develop programs in synthetic lethality, an emerging field in oncology. From 2015 to 2018, Mr. Hata served as an Executive-in-Residence at 5AM Ventures. From 2014 to August 2015, he was Chief Operating Officer at Flexus Biosciences where he helped lead the company through its acquisition by Bristol-Myers Squibb in April 2015, and then he served as Chief Operating Officer at RAPT Therapeutics (formerly FLX Bio). Before then, Mr. Hata held roles of increasing responsibility, most recently as Vice President, Corporate Development and Strategy, at Onyx Pharmaceuticals, when the company achieved approvals of KYPROLIS® and STIVARGA®, leading to its acquisition by Amgen in October 2013. Previously Mr. Hata held business development roles at Enanta and at ImClone Systems, now a subsidiary of Eli Lilly and Company.

    Mr. Hata serves on the Boards of Directors of Xencor and Expansion Therapeutics and is a Board Member of the Moores Cancer Center at the University of California, San Diego. He obtained his M.B.A. from the University of Pennsylvania, his B.A. in Chemistry from Colorado College, and participated in undergraduate studies in Chemistry and Biology at Oxford University.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV), non-alcoholic steatohepatitis (NASH) and SARS-CoV-2 (COVID-19). Enanta is also conducting research in human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  3. - Initial Data Expected in the First Half of 2022 -

    Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer being developed for use in an all-oral combination regimen for chronic HBV patients.

    "We are pleased to advance our HBV program by dosing the first subject in our Phase 1 clinical study of EDP-721, an orally administered HBV RNA destabilizer that has the potential to reduce S antigen. As we believe that achieving a functional cure for HBV will involve a combination approach, this…

    - Initial Data Expected in the First Half of 2022 -

    Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer being developed for use in an all-oral combination regimen for chronic HBV patients.

    "We are pleased to advance our HBV program by dosing the first subject in our Phase 1 clinical study of EDP-721, an orally administered HBV RNA destabilizer that has the potential to reduce S antigen. As we believe that achieving a functional cure for HBV will involve a combination approach, this milestone brings us closer to our vision of developing an all-oral regimen for HBV," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "The current standard of care for chronic HBV involves nucleoside reverse transcriptase inhibitors, or NUCs, which can suppress HBV replication. In addition, EDP-514, our potent core inhibitor inhibits several stages of HBV replication, from uncoating and nuclear import of the virus, to capsid assembly and recycling. Now, with EDP-721, we have an oral compound that has demonstrated preclinically the ability to destabilize HBV RNAs, leading to a reduction in viral proteins, including S antigen, which we believe is essential for the treatment of HBV. With this triple combination of a NUC, EDP-514, and EDP-721, we see the potential for an all-oral functional cure and look forward to progressing this study."

    This two-part Phase 1a/b study will initially evaluate the safety, tolerability, and pharmacokinetics of EDP-721 in single and multiple ascending oral doses in healthy volunteers. The second part, in chronic HBV patients, will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of multiple ascending oral doses of EDP-721 with or without a NUC, and then in combination with EDP-514. Data from the first part of the study are expected in the first half of 2022.

    In a recent poster presentation at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2021, EDP-721 was shown to be a selective inhibitor of the non-canonical poly(A) polymerases, PAPD5 and PAPD7, which are host factors critical to the post-transcriptional stabilization of HBV RNA. Inhibition of PAPD5/7 results in potent and pangenotypic reduction in HBsAg production with minimal effects on the host transcriptome in uninfected primary human hepatocytes. Oral administration of EDP-721 demonstrated HBsAg reductions of up to 3 log10 IU/mL following 14 days of once-daily dosing in the AAV-HBV mouse model. EDP-721 was also shown to exhibit synergistic antiviral activity in vitro when combined with nucleos(t)ide reverse transcriptase inhibitors or the HBV core inhibitor EDP-514.

    About Hepatitis B Virus

    Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The virus is most commonly transmitted from mother to child during birth and delivery, as well as through contact with blood or other body fluids.1 It is estimated that over 290 million people worldwide have chronic HBV infection.2 Current approaches to treatment include interferon therapy and/or nucleos(t)ide reverse transcriptase inhibitors. Treatment with interferon offers poor cure rates and is accompanied by serious side effects.3 Nucleos(t)ide reverse transcriptase inhibitors can be very effective at suppressing the virus but rarely result in full eradication of the virus from the liver.4

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV), non-alcoholic steatohepatitis (NASH), and SARS-CoV-2 (COVID-19). Enanta is also conducting research in human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of EDP-721 for HBV. Statements that are not historical facts, are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta's research and development pipeline, such as HBV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HBV; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended June 30, 2021 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    _____________________________

    1.https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

    2.https://pubmed.ncbi.nlm.nih.gov/29599078/

    3.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5401664/

    4.https://pubmed.ncbi.nlm.nih.gov/30342034/

    View Full Article Hide Full Article
    • Nominates EDP-235, an Oral Protease Inhibitor Specifically Designed to Treat COVID-19, with a Phase 1 Study Planned for Early 2022
    • On Track to Dose First Subject in a Phase 1 Study of EDP-721, an Oral, Hepatitis B Virus (HBV) RNA Destabilizer
    • Recently Reported Positive Preliminary Data from a Phase 1b Study of EDP-514 in Viremic Chronic HBV Patients Supportive of Once Daily Dosing and Demonstrating a Mean Reduction of 3.3 Logs in HBV DNA
    • Royalty Revenue for the Quarter was $21.6 Million

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal third quarter ended June 30, 2021…

    • Nominates EDP-235, an Oral Protease Inhibitor Specifically Designed to Treat COVID-19, with a Phase 1 Study Planned for Early 2022
    • On Track to Dose First Subject in a Phase 1 Study of EDP-721, an Oral, Hepatitis B Virus (HBV) RNA Destabilizer
    • Recently Reported Positive Preliminary Data from a Phase 1b Study of EDP-514 in Viremic Chronic HBV Patients Supportive of Once Daily Dosing and Demonstrating a Mean Reduction of 3.3 Logs in HBV DNA
    • Royalty Revenue for the Quarter was $21.6 Million

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal third quarter ended June 30, 2021.

    "This was an important quarter for Enanta, and I am proud of the work we have accomplished and the significant milestones we have achieved to advance our clinical portfolio in key therapeutic areas," stated Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "We are excited today to nominate EDP-235, our novel, potent, oral protease inhibitor specifically designed to target SARS-CoV-2. As the COVID-19 pandemic continues to have a significant impact globally, we are committed to leveraging our expertise in virology to progress this program and initiate a Phase 1 clinical study in early 2022. We are also pleased to be on track to dose our first subject this month in the Phase 1 study of EDP-721, our oral HBV RNA destabilizer, which we believe will be an important component of an all-oral, functional cure for chronic HBV. This progress follows recent positive data from two Phase 1b studies of our core inhibitor EDP-514, one in chronic HBV patients already being treated with a nucleoside reverse transcriptase inhibitor and the other in viremic patients not currently on treatment. Looking toward the second half of the year, we are excited to continue our progress and advance several clinical candidates in our pipeline."

    Fiscal Third Quarter Ended June 30, 2021 Financial Results

    Total revenue of $21.6 million for the three months ended June 30, 2021 consisted of royalty revenue derived primarily from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®. This compared to total revenue of $18.7 million for the three months ended June 30, 2020, which also consisted of royalty revenue. AbbVie has stated that net sales of MAVYRET/MAVIRET in the three months ended June 30, 2021 increased compared to 2020, although a residual impact from the pandemic continues.

    Research and development expenses increased to $47.0 million for the three months ended June 30, 2021, compared to $34.7 million for the three months ended June 30, 2020. The increase was due to the timing of the company's clinical trials year over year.

    General and administrative expenses totaled $8.5 million for the three months ended June 30, 2021, compared to $6.8 million for the three months ended June 30, 2020. The increase was due to an increase in headcount and related compensation expense.

    Enanta recorded an income tax benefit of $9.4 million for the three months ended June 30, 2021 compared to an income tax benefit of $7.1 million for the same period in 2020. These income tax benefits were due to the provision of the CARES Act of 2020, which enables the company through fiscal 2021 to carry back its projected current year tax loss to offset taxable income in prior years.

    Net loss for the three months ended June 30, 2021 was $24.0 million, or a loss of $1.19 per diluted common share, compared to net loss of $14.3 million, or a loss of $0.71 per diluted common share, for the corresponding period in 2020.

    Enanta's cash, cash equivalents and marketable securities totaled $372.5 million at June 30, 2021. Enanta expects that its current cash, cash equivalents and short-term and long-term marketable securities, as well as its continuing royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of its existing business and development programs for at least the next two years.

    Pipeline Program -- Recent Events and Near-Term Milestones

    Virology

    • HBV: Core Inhibitor EDP-514 and HBV RNA Destabilizer EDP-721
      • On track to dose the first subject this month in a Phase 1 clinical study of EDP-721, an oral, potent and selective HBV RNA destabilizer being developed for use in combination with other mechanisms, with the goal of developing an all-oral regimen to achieve a functional cure. Data are expected in the first half of 2022.
      • Announced positive data from a Phase 1b study of EDP-514 in viremic chronic HBV patients, which demonstrated that the 200 mg and 400 mg doses were safe and well-tolerated through 28 days of treatment, displayed pharmacokinetics supportive of once-daily dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3 logs, respectively.
      • Presented the discovery and preclinical characterization of EDP-721 in a poster at the International Liver CongressTM, sponsored by the European Association for the Study of the Liver (EASL).
    • COVID-19 (SARS-CoV-2): Protease Inhibitor EDP-235
      • Nominated EDP-235, the company's lead oral protease inhibitor specifically designed for the treatment of COVID-19 and is on track to initiate a Phase 1 study in early 2022.
    • Respiratory Syncytial Virus (RSV): N-Protein Inhibitor EDP-938
      • While RSV, like influenza, did not emerge during the usual late-fall and winter RSV season in the Northern Hemisphere in 2020-2021, the Centers for Disease Control and Prevention recently issued a health advisory to notify clinicians and caregivers about increased interseasonal RSV activity across parts of the Southern United States. As RSV re-emerges, Enanta is continuing to establish additional trial sites in North America, Europe, the Asia-Pacific region, and the Southern Hemisphere.
      • Given the recent re-emergence of RSV is not following any normal seasonal pattern, it is very difficult to predict how significant or sustained the new incidence of RSV will be moving forward. Enanta is hopeful that enrollment in the RSVP study will be complete during the Northern Hemisphere winter season if there are no renewed social distancing interventions. Assuming this enrollment occurs, the company would expect data in first half of 2022.
      • For RSVTx and RSVPEDs, which were initiated more recently, Enanta is monitoring the trends and will update as appropriate.
    • Respiratory Virology Discovery Initiatives – Having recently nominated EDP-235 as a clinical development candidate, Enanta's goal in the second half of 2021 is to identify one more clinical development candidate among the two discovery initiatives below:
      • RSV L-Protein Inhibitor
        • Continuing to optimize leads with potent nanomolar activity against both RSV-A and RSV-B.
      • Human Metapneumovirus (hMPV)
        • Continuing lead optimization on potent nanomolar hMPV inhibitors.

    Non-Alcoholic Steatohepatitis

    • Farnesoid X Receptor (FXR) Agonist EDP-305
      • ARGON-2, a Phase 2b study of EDP-305, is on track for a planned 12-week internal interim analysis on a subset of patients in the third quarter of 2021 to inform next steps.
    • EDP-297, a Highly Potent and Targeted FXR Agonist
      • Data are expected from the Phase 1 study of EDP-297 in the third quarter of 2021.

    Corporate

    • Announced the planned retirement of Nathalie Adda, M.D., Senior Vice President and Chief Medical Officer, in February 2022, with a period of consulting thereafter.

    Upcoming Events and Presentations

    • H.C. Wainwright 23rd Annual Global Investment Conference (September 13-14, 2021)
    • Baird 2021 Global Healthcare Conference (September 14-15, 2021)
    • Enanta plans to issue its fiscal fourth quarter and year-end financial results press release, and hold a conference call regarding those results, on November 22, 2021.

    Conference Call and Webcast Information

    Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on August 5, 2021, through 11:59 p.m. ET on August 9, 2021 by dialing 855-859-2056 from the U.S. or 404-537-3406 for international callers. The passcode for both the live call and the replay is 5637368. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV), non-alcoholic steatohepatitis (NASH) and SARS-CoV-2 (COVID-19). Enanta is also conducting research in human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's research and development programs in RSV, HBV, NASH, SARS-CoV-2 and hMPV, as well as future royalty revenue from sales of AbbVie's MAVYRET/MAVIRET regimen for HCV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the dependence of Enanta's revenues in the short-term upon the continued success of AbbVie's sales of its MAVYRET/MAVIRET HCV regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, NASH, HBV, hMPV and SARS-CoV-2; treatment rates, competitive pricing, and reimbursement rate actions affecting MAVYRET/MAVIRET compared to competitive HCV products on the market; any continuing impact of COVID-19 on AbbVie's MAVYRET/MAVIRET sales; the discovery and development risks of Enanta's research and development programs in RSV, NASH, HBV, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; the realizability of our deferred tax assets; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2021, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    UNAUDITED
    (in thousands, except per share amounts)
             
      Three Months Ended   Nine Months Ended
      June 30,   June 30,
     

    2021

     

    2020

     

    2021

     

    2020

             
    Revenue  

    $

    21,624

     

     

    $

    18,653

     

     

    $

    73,499

     

     

    $

    98,842

     

    Operating expenses        
    Research and development  

     

    46,994

     

     

     

    34,682

     

     

     

    125,165

     

     

     

    100,070

     

    General and administrative  

     

    8,477

     

     

     

    6,823

     

     

     

    24,180

     

     

     

    20,628

     

    Total operating expenses  

     

    55,471

     

     

     

    41,505

     

     

     

    149,345

     

     

     

    120,698

     

    Loss from operations  

     

    (33,847

    )

     

     

    (22,852

    )

     

     

    (75,846

    )

     

     

    (21,856

    )

    Other income, net  

     

    439

     

     

     

    1,445

     

     

     

    1,661

     

     

     

    5,471

     

    Loss before income taxes  

     

    (33,408

    )

     

     

    (21,407

    )

     

     

    (74,185

    )

     

     

    (16,385

    )

    Income tax benefit  

     

    9,384

     

     

     

    7,142

     

     

     

    19,788

     

     

     

    9,558

     

    Net loss  

    $

    (24,024

    )

     

    $

    (14,265

    )

     

    $

    (54,397

    )

     

    $

    (6,827

    )

    Net loss per share        
    Basic  

    $

    (1.19

    )

     

    $

    (0.71

    )

     

    $

    (2.70

    )

     

    $

    (0.34

    )

    Diluted  

    $

    (1.19

    )

     

    $

    (0.71

    )

     

    $

    (2.70

    )

     

    $

    (0.34

    )

    Weighted average common shares outstanding        
    Basic  

     

    20,201

     

     

     

    20,020

     

     

     

    20,155

     

     

     

    19,897

     

    Diluted  

     

    20,201

     

     

     

    20,020

     

     

     

    20,155

     

     

     

    19,897

     

    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    UNAUDITED
    (in thousands)
         
      June 30,   September 30,
     

    2021

     

    2020

    Assets    
    Current assets    
    Cash and cash equivalents  

    $

    4,601

     

    $

    87,131

    Short-term marketable securities  

     

    252,223

     

     

    299,518

    Accounts receivable  

     

    21,624

     

     

    23,492

    Prepaid expenses and other current assets  

     

    12,137

     

     

    13,655

    Income tax receivable  

     

    30,570

     

     

    13,041

    Total current assets  

     

    321,155

     

     

    436,837

    Long-term marketable securities  

     

    115,706

     

     

    32,634

    Property and equipment, net  

     

    6,613

     

     

    8,596

    Deferred tax assets  

     

    345

     

     

    345

    Operating lease, right-of-use assets  

     

    5,917

     

     

    7,020

    Restricted cash  

     

    608

     

     

    608

    Other long-term assets  

     

    92

     

     

    92

    Total assets  

    $

    450,436

     

    $

    486,132

    Liabilities and Stockholders' Equity    
    Current liabilities    
    Accounts payable  

    $

    5,895

     

    $

    5,737

    Accrued expenses and other current liabilities  

     

    17,695

     

     

    14,159

    Operating lease liabilities  

     

    5,034

     

     

    4,261

    Total current liabilities  

     

    28,624

     

     

    24,157

    Operating lease liabilities, net of current portion  

     

    1,637

     

     

    3,838

    Series 1 nonconvertible preferred stock  

     

    1,479

     

     

    1,479

    Other long-term liabilities  

     

    846

     

     

    1,078

    Total liabilities  

     

    32,586

     

     

    30,552

    Total stockholders' equity  

     

    417,850

     

     

    455,580

    Total liabilities and stockholders' equity  

    $

    450,436

     

    $

    486,132

     

    View Full Article Hide Full Article
  4. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the nomination of EDP-235, its lead oral protease inhibitor specifically designed for the treatment of COVID-19. Enanta plans to advance EDP-235 into the clinic early next year.

    "The nomination of EDP-235 represents an important milestone for Enanta and highlights the strength of our experience in developing small molecule drugs for the treatment of viral infections at this critical time in the global fight against COVID-19," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "As the virus continues to rapidly mutate, there…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the nomination of EDP-235, its lead oral protease inhibitor specifically designed for the treatment of COVID-19. Enanta plans to advance EDP-235 into the clinic early next year.

    "The nomination of EDP-235 represents an important milestone for Enanta and highlights the strength of our experience in developing small molecule drugs for the treatment of viral infections at this critical time in the global fight against COVID-19," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "As the virus continues to rapidly mutate, there remains a need for an oral, direct-acting antiviral that potently inhibits viral replication. While vaccines and antibody therapeutics in development today target the viral spike protein, EDP-235 has been specifically designed to target conserved regions in the active site of a viral enzyme essential for SARS-CoV-2 replication, so we do not expect mutations in the spike protein to affect the activity of our candidate. We are encouraged by the promising preclinical data generated to date, which has demonstrated potent and selective inhibition of SARS-CoV-2, and we look forward to progressing EDP-235 into the clinic."

    EDP-235 potently and selectively inhibits SARS-CoV-2 replication in multiple cellular models, including primary human airway epithelial cells, with an EC90 of 33nM. EDP-235 retained activity against protease enzymes from currently circulating SARS-CoV-2 variants. Additionally, EDP-235 has a clean preclinical safety profile and has demonstrated a high barrier to resistance. Importantly, EDP-235 has excellent lung distribution in rats and demonstrates properties supportive of once daily oral dosing, in contrast to other protease inhibitors currently in development. Furthermore, EDP-235 has shown activity against other coronaviruses, providing the opportunity to potentially treat other infections that may emerge in the future.

    Enanta will apply for Fast Track designation and expects to initiate a Phase 1 single and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of EDP-235 in approximately 75 healthy volunteers in early 2022.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV), non-alcoholic steatohepatitis (NASH) and SARS-CoV-2 (COVID-19). Enanta is also conducting research in human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of EDP-235 for SARS-CoV-2. Statements that are not historical facts, are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the risks of early stage development efforts in the disease areas in Enanta's research and development pipeline, such as COVID-19; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for COVID-19; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2021 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    View Full Article Hide Full Article
  5. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal third quarter ended June 30, 2021 after the U.S. markets close on August 5, 2021. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal third quarter ended June 30, 2021 after the U.S. markets close on August 5, 2021. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on August 5, 2021, through 11:59 p.m. ET on August 9, 2021 by dialing 855-859-2056 from the U.S. or 404-537-3406 for international callers. The passcode for both the live call and the replay is 5637368. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  6. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Nathalie Adda, M.D., Senior Vice President and Chief Medical Officer, will retire from Enanta in February 2022 and continue to serve as a consultant to the company thereafter. Enanta is commencing a search to identify Dr. Adda's successor.

    "On behalf of the entire Enanta team and our Board of Directors, I thank Nathalie for her dedication to the company," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "During her tenure since joining us in 2015, Nathalie has been responsible for building and overseeing Enanta's Clinical…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Nathalie Adda, M.D., Senior Vice President and Chief Medical Officer, will retire from Enanta in February 2022 and continue to serve as a consultant to the company thereafter. Enanta is commencing a search to identify Dr. Adda's successor.

    "On behalf of the entire Enanta team and our Board of Directors, I thank Nathalie for her dedication to the company," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "During her tenure since joining us in 2015, Nathalie has been responsible for building and overseeing Enanta's Clinical and Regulatory Department. Nathalie's significant contributions have supported the growth of our robust pipeline of four clinical candidates across respiratory syncytial virus, hepatitis B virus and non-alcoholic steatohepatitis. Under her expertise and direction, Enanta has progressed candidates for these indications into the clinic and is advancing a fifth into a Phase 1 study soon. We wish Nathalie the very best in her retirement and are grateful that we will continue to benefit from her deep knowledge through her consulting role."

    "Working with the entire Enanta team to advance our vision of becoming a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases has been a privilege and deeply rewarding, and I am grateful for the opportunity to have built and led the Clinical and Regulatory team to achieve several important milestones to further our vision," said Nathalie Adda, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. "I believe Enanta is well-positioned to progress not only these clinical programs, but also its entire pipeline, to bring meaningful new treatments to patients."

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of Enanta's clinical pipeline. Statements that are not historical facts, are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage clinical development in the disease areas in Enanta's research and development pipeline; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2021 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    View Full Article Hide Full Article
  7. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported new preclinical data for EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer being developed for use in an all-oral combination regimen for HBV. The data demonstrate potent, selective and pangenotypic inhibition of HBV surface antigen (HBsAg), with up to a 3-log drop in the AAV-HBV mouse model. The research on EDP-721 was presented in a poster titled Discovery and Characterization of EDP-721, a Novel Hepatitis B Virus RNA Destabilizer, during the EASL International Liver Congress™ 2021.

    "The data presented today strongly support the continued development…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported new preclinical data for EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer being developed for use in an all-oral combination regimen for HBV. The data demonstrate potent, selective and pangenotypic inhibition of HBV surface antigen (HBsAg), with up to a 3-log drop in the AAV-HBV mouse model. The research on EDP-721 was presented in a poster titled Discovery and Characterization of EDP-721, a Novel Hepatitis B Virus RNA Destabilizer, during the EASL International Liver Congress™ 2021.

    "The data presented today strongly support the continued development of EDP-721 for use in an all-oral regimen to provide a functional cure for HBV," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "While existing therapies for chronic HBV are moderately effective at suppressing HBV DNA, high levels of HBsAg present a key barrier to enduring viral clearance. These new preclinical data demonstrate that EDP-721 significantly reduced HBsAg production up to 3 logs and exhibited additive to synergistic activity with antivirals that target different mechanisms. We look forward to initiating a Phase 1 trial evaluating EDP-721 in mid-2021 and subsequently studying the compound in combination with other mechanisms, including our core inhibitor, EDP-514, and nucleoside reverse transcriptase inhibitors."

    EDP-721 was shown to be a selective inhibitor of the non-canonical poly(A) polymerases, PAPD5 and PAPD7, host factors critical to the post-transcriptional stabilization of HBV RNA. Inhibition of PAPD5/7 results in potent and pangenotypic reduction in HBsAg production with minimal effects on the host transcriptome in uninfected primary human hepatocytes. Oral administration of EDP-721 demonstrated HBsAg reductions of up to 3 logs following 14 days of once-daily dosing in the AAV-HBV mouse model. EDP-721 was also shown to exhibit synergistic antiviral activity in vitro when combined with nucleos(t)ide reverse transcriptase inhibitors or the HBV core inhibitor EDP-514.

    Enanta expects to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety and tolerability of EDP-721 in healthy volunteers in mid-2021.

    About Hepatitis B Virus

    Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The virus is most commonly transmitted from mother to child during birth and delivery, as well as through contact with blood or other body fluids. It is estimated that over 290 million people worldwide have chronic HBV infection.1 Current approaches to treatment include interferon therapy and/or nucleos(t)ide reverse transcriptase inhibitors. Treatment with interferon offers poor cure rates and is accompanied by serious side effects.2 Nucleos(t)ide reverse transcriptase inhibitors can be very effective at suppressing the virus but rarely result in full eradication of the virus from the liver.3

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of EDP-721 for HBV. Statements that are not historical facts, are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta's research and development pipeline, such as HBV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HBV; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2021 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    _____________________________

    1https://pubmed.ncbi.nlm.nih.gov/29599078/

    2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5401664/

    3https://pubmed.ncbi.nlm.nih.gov/30342034/

    View Full Article Hide Full Article
  8. Positive 28-Day Data from First Two EDP-514 Dose Cohorts: 200 mg and 400 mg

    EDP-514 was Safe and Well-Tolerated with Pharmacokinetics Supportive of Once-Daily, Oral Dosing

    Patients Dosed with 400 mg EDP-514 Showed a Mean Reduction of 3.3 Logs in HBV DNA

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced positive data from the first two dose cohorts of its Phase 1b study of EDP-514 in viremic chronic HBV patients who were not being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, Enanta's novel class II oral HBV core inhibitor, was safe and well-tolerated through…

    Positive 28-Day Data from First Two EDP-514 Dose Cohorts: 200 mg and 400 mg

    EDP-514 was Safe and Well-Tolerated with Pharmacokinetics Supportive of Once-Daily, Oral Dosing

    Patients Dosed with 400 mg EDP-514 Showed a Mean Reduction of 3.3 Logs in HBV DNA

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced positive data from the first two dose cohorts of its Phase 1b study of EDP-514 in viremic chronic HBV patients who were not being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, Enanta's novel class II oral HBV core inhibitor, was safe and well-tolerated through 28 days of treatment, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3 logs at 28 days for the 200 mg and 400 mg cohorts, respectively.

    "We are extremely pleased with these promising clinical results for EDP-514, which are comparable to the best antiviral effects reported for any core inhibitor to date and also extend the compound's excellent safety and tolerability profile," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "In particular, we are encouraged by the rapid and robust declines in HBV DNA, which position EDP-514 to be a key component of a combination regimen for HBV. We believe EDP-514, in combination with a NUC and other mechanisms, could provide a foundation for an all-oral treatment approach to achieve functional cures in patients with chronic HBV infection. We look forward to progressing EDP-514 in combination with our oral HBV RNA destabilizer, EDP-721, a compound that has demonstrated significant reductions in HBsAg preclinically and which we expect to advance into the clinic mid-year. Ultimately, our all-oral, triple combination approach could provide potent suppression of multiple key steps in HBV replication, including HBV DNA, HBV RNA and HBsAg, to achieve our goal of developing a functional cure for HBV patients."

    The randomized, double-blind, placebo-controlled Phase 1b study is evaluating the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in viremic patients with chronic HBV infection, either HBeAg-positive or HBeAg-negative, and without cirrhosis. Patients were randomized to receive 200 mg (n=6), 400 mg (n=6), or 800 mg (n=6) of EDP-514 or placebo (n=6) daily for 28 days with an 8-week follow-up period. The 800 mg cohort is ongoing and final study results will be presented at a future scientific conference.

    Of the sixteen patients randomized in the first two dose cohorts (6 active and 2 placebo per cohort), majorities were male (56%), Asian (100%) and HBeAg-negative (94%), with a mean age of 45 years, mean baseline HBV DNA of 4.87 logs IU/mL, and mean baseline HBV RNA of 3.45 logs IU/mL. Overall, six patients reported treatment emergent adverse events (TEAEs) and all were mild except for 4 moderate events (2 in placebo and 2 in the 200 mg cohort) both of which were considered unlikely related to drug. No grade 3 TEAEs or serious adverse events, grade 3/4 clinical laboratory abnormalities, ALT/AST elevations or clinically relevant electrocardiogram (ECG) or vital sign changes were observed in the EDP-514 groups. EDP-514 exposure increased linearly with dose, with concentrations up to approximately 20-fold the protein-adjusted EC50 (9-fold for 200 mg, 20-fold for 400 mg).

    At Day 28, mean reductions in HBV DNA were 2.9, 3.3, and 0.2 logs IU/mL in the 200 mg, 400 mg and placebo groups, respectively, with a maximum reduction of 4.2 logs vs. 0.5 log in placebo. HBV DNA was below the lower level of quantitation (LLOQ) in 4 patients treated with EDP-514 compared to none in the placebo group. Mean HBV RNA reductions of 2.9, 2.4 and 0.3 logs IU/mL were observed in the 200 mg, 400 mg and placebo groups, respectively, with a maximum reduction of 4.8 logs vs. 1.9 logs in placebo. HBV RNA was undetectable at Day 28 in 8 patients treated with EDP-514 vs. none in placebo. As expected, no clinically significant changes in levels of HBsAg, HBeAg, or HBcrAg were observed.

    About EDP-514

    EDP-514 is Enanta's lead HBV core inhibitor candidate. Core inhibitors, also known as capsid assembly modulators or core protein allosteric modulators, are a novel class of HBV replication inhibitors that have been shown to act at multiple steps in the HBV lifecycle. Preclinical data demonstrate that EDP-514 is a potent inhibitor of HBV replication and prevents the de novo formation of new HBV cccDNA in primary human hepatocytes when given early during HBV infection. In vitro data also show that EDP-514 is pan-genotypic, and that combinations of EDP-514 with a NUC, the current anti-viral therapy for HBV, or with a class I core inhibitor, result in additive to synergistic antiviral effects. ln vivo models of EDP-514 demonstrate excellent efficacy with a greater than 4-log viral load reduction in HBV-infected PXB mice.

    About Hepatitis B Virus

    Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The virus is most commonly transmitted from mother to child during birth and delivery, as well as through contact with blood or other body fluids. It is estimated that over 290 million people worldwide have chronic HBV infection.1 Current approaches to treatment include interferon therapy and/or NUCs. Treatment with interferon offers poor cure rates and is accompanied by serious side effects.2 NUCs can be very effective at suppressing the virus but rarely result in full eradication of the virus from the liver.3

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of EDP-514 for HBV. Statements that are not historical facts, are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the risks of early stage development efforts in the disease areas in Enanta's research and development pipeline, such as HBV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HBV; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2021 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    1https://pubmed.ncbi.nlm.nih.gov/29599078/

    2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5401664/

    3https://pubmed.ncbi.nlm.nih.gov/30342034/

    View Full Article Hide Full Article
  9. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in two virtual investor conferences being webcast in June:

    • The JMP Securities Life Sciences Conference: Fireside Chat at 10:30 a.m. ET on June 17, 2021
    • Raymond James Human Health Innovation Conference: Presentation at 10:40 a.m. ET on June 21, 2021

    A live webcast of each event will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. Replays of the webcasts will be available following the presentations…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in two virtual investor conferences being webcast in June:

    • The JMP Securities Life Sciences Conference: Fireside Chat at 10:30 a.m. ET on June 17, 2021
    • Raymond James Human Health Innovation Conference: Presentation at 10:40 a.m. ET on June 21, 2021

    A live webcast of each event will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. Replays of the webcasts will be available following the presentations and will be archived for at least 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  10. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the company will have a poster presentation showcasing preclinical data for EDP-721, a novel, potent and selective oral HBV RNA destabilizer being developed for use in an all-oral functional cure of hepatitis B virus, at the upcoming European Association for the Study of the Liver's (EASL) International Liver Congress 2021, being held virtually June 23-26, 2021.

    Details of the poster presentation are as follows:
    Date/Time: June 23, 2021, 08:00 CET
    Poster 942: Discovery and characterization of EDP-721, a novel hepatitis B virus RNA destabilizer
    Session Name…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the company will have a poster presentation showcasing preclinical data for EDP-721, a novel, potent and selective oral HBV RNA destabilizer being developed for use in an all-oral functional cure of hepatitis B virus, at the upcoming European Association for the Study of the Liver's (EASL) International Liver Congress 2021, being held virtually June 23-26, 2021.

    Details of the poster presentation are as follows:

    Date/Time: June 23, 2021, 08:00 CET

    Poster 942: Discovery and characterization of EDP-721, a novel hepatitis B virus RNA destabilizer

    Session Name: Viral Hepatitis B/D: Therapy

    Presenter: Michael Vaine, Ph.D., United States

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  11. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the RBC Capital Markets Global Healthcare Conference on May 18, 2021 at 1:20 p.m. ET.

    A webcast of the event will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the event and will be archived for approximately 90 days.

    About Enanta
    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the RBC Capital Markets Global Healthcare Conference on May 18, 2021 at 1:20 p.m. ET.

    A webcast of the event will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the event and will be archived for approximately 90 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
    • Reported Positive Data from a Phase 1b Study of EDP-514 in NUC-Suppressed Chronic Hepatitis B Virus (HBV) Patients Supporting Once Daily Dosing and Combination Approach
    • On Track to Report Preliminary Data from a Phase 1b Study of EDP-514 in Viremic Chronic HBV Patients in Q2 2021 and to Initiate a Phase 1 Study of EDP-721 in Mid-2021
    • IND-Enabling Studies of a Lead Oral Protease Inhibitor Specifically Designed for SARS-CoV-2 Expected to Begin in Q2 2021
    • Initiated RSVPEDs, a Phase 2 Study of EDP-938 in Pediatric Patients with Respiratory Syncytial Virus (RSV) Infection
    • Royalty Revenue for the Quarter was $20 Million
    • Cash and Marketable Securities Totaled $400 Million at March 31, 2021

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a…

    • Reported Positive Data from a Phase 1b Study of EDP-514 in NUC-Suppressed Chronic Hepatitis B Virus (HBV) Patients Supporting Once Daily Dosing and Combination Approach
    • On Track to Report Preliminary Data from a Phase 1b Study of EDP-514 in Viremic Chronic HBV Patients in Q2 2021 and to Initiate a Phase 1 Study of EDP-721 in Mid-2021
    • IND-Enabling Studies of a Lead Oral Protease Inhibitor Specifically Designed for SARS-CoV-2 Expected to Begin in Q2 2021
    • Initiated RSVPEDs, a Phase 2 Study of EDP-938 in Pediatric Patients with Respiratory Syncytial Virus (RSV) Infection
    • Royalty Revenue for the Quarter was $20 Million
    • Cash and Marketable Securities Totaled $400 Million at March 31, 2021

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal second quarter ended March 31, 2021.

    "This quarter was marked by meaningful progress, particularly as we further our efforts to develop an all-oral regimen for chronic HBV patients," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "We are especially pleased with the safety, tolerability, pharmacokinetic, and HBV RNA data we announced today from our Phase 1b study in NUC-suppressed patients, which reinforces our belief in EDP-514's potential to serve as the foundation of an oral combination treatment approach to achieve a functional cure in patients with HBV. We also remain on track for other key milestones in our HBV program later this quarter, including reporting preliminary data from our Phase 1b trial of EDP-514 in viremic chronic HBV patients and initiating a Phase 1 study of EDP-721, our novel HBV RNA destabilizer. Looking to the rest of our pipeline, we are excited to soon initiate IND-enabling studies of a lead oral protease inhibitor specifically designed to target SARS-CoV-2, with a goal of beginning a Phase 1 study in early 2022. Each milestone we achieve brings us closer to our vision of being a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases."

    Fiscal Second Quarter Ended March 31, 2021 Financial Results

    Total revenue for the three months ended March 31, 2021 was $20.1 million and consisted of royalty revenue derived primarily from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir), which continued to be adversely impacted by the pandemic. For the three months ended March 31, 2020, total revenue from royalties on AbbVie's net sales of HCV regimens was $27.6 million.

    Research and development expenses totaled $41.5 million for the three months ended March 31, 2021, compared to $32.6 million for the three months ended March 31, 2020. The increase in research and development expenses was primarily due to the timing of the company's clinical trials year over year.

    General and administrative expenses totaled $8.3 million for the three months ended March 31, 2021, compared to $6.9 million for the three months ended March 31, 2020. The increase in general and administrative expenses was due to increased headcount and compensation expense.

    Enanta recorded an income tax benefit of $7.1 million for the three months ended March 31, 2021, compared to an income tax benefit of $3.9 million for the same period of 2020. The income tax benefit during the three months ended March 31, 2021 was due to the provision of the CARES Act of 2020, which enables the Company to carry back its projected current year tax loss to offset taxable income in prior years.

    Net loss for the three months ended March 31, 2021 was $22.0 million, or a loss of $1.09 per diluted common share, compared to a net loss of $6.0 million, or a loss of $0.30 per diluted common share, for the corresponding period in 2020.

    Enanta's cash, cash equivalents and short-term and long-term marketable securities totaled $400.4 million at March 31, 2021. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its continuing royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.

    Pipeline Programs and Near-Term Milestones

    Virology

    • HBV: Core Inhibitor EDP-514 and RNA Destabilizer EDP-721
      • Positive preliminary data announced today from the Phase 1b study of EDP-514 in NUC-suppressed chronic HBV patients. The 200 mg and 400 mg doses were safe and well-tolerated, with pharmacokinetics supportive of once daily dosing. The 800 mg cohort is ongoing and final study results will be presented at a future scientific conference.
      • Preliminary data expected from the ongoing Phase 1b study of EDP-514 in viremic chronic HBV patients in the second quarter of 2021.
      • On track to initiate a Phase 1 clinical study of EDP-721 in mid-2021. EDP-721 is an oral, potent and selective HBV RNA destabilizer being developed for use in combination with other mechanisms, with the goal of achieving an all-oral functional cure.
      • Presenting the discovery and preclinical characterization of EDP-721 in a poster at the International Liver CongressTM, sponsored by the European Association for the Study of the Liver (EASL), in June.
    • RSV: N-Protein Inhibitor EDP-938
      • Due to ongoing COVID-19 mitigation measures, RSV, like influenza, did not emerge during the usual late-fall and winter RSV season in the Northern Hemisphere in 2020-2021. Enanta continues its preparedness efforts to establish trial sites in North America, Europe, the Asia-Pacific region, and the Southern Hemisphere.
        • Continuing extensive efforts to double the number of clinical sites globally for RSVP, a Phase 2b randomized, double-blind, placebo-controlled study in 70 adult outpatients with community-acquired RSV infection.
        • Initiated RSVPEDs, a Phase 2 randomized, double-blind, placebo-controlled study in 90 pediatric RSV patients, in March 2021.
        • Continuing to activate sites for RSVTx, a Phase 2b randomized, double-blind, placebo-controlled study in 200 adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection.
    • Respiratory Virology Discovery Initiatives – In 2021, Enanta expects to identify two clinical development candidates among its three discovery initiatives below:
      • COVID-19
        • IND-enabling studies of a lead oral protease inhibitor specifically designed for SARS-CoV-2 are expected to begin later this quarter, with the goal to have a candidate in a Phase 1 study in early 2022.
      • RSV L-Protein Inhibitor
        • Optimization of leads with potent nanomolar activity against both RSV-A and RSV-B is ongoing, with potential for use alone or in combination with agents targeting other RSV mechanisms, such as EDP-938, to possibly broaden the addressable treatment window or patient population.
      • Human Metapneumovirus (hMPV)
        • Lead optimization on potent nanomolar hMPV inhibitors is currently ongoing.

    NASH

    • Farnesoid X Receptor (FXR) Agonist EDP-305
      • Continuing recruitment and dosing in ARGON-2 Phase 2b study of EDP-305, with a blinded 12-week internal interim analysis on a subset of patients to inform next steps, is expected in the third quarter of 2021, rather than in mid-year.
    • EDP-297, a Highly Potent and Targeted FXR Agonist
      • Continuing recruitment and dosing in a Phase 1 study of EDP-297, with data expected in mid-2021.

    Upcoming Events and Presentations

    • RBC Capital Markets Global Healthcare Conference (May 18-19, 2021)
    • JMP Securities 2021 Life Sciences Conference (June 16-17, 2021)
    • Raymond James Human Health Innovation Conference (June 21-23, 2021)
    • The International Liver Congress™ 2021 sponsored by EASL (June 23-26, 2021)
    • Enanta plans to issue its fiscal third quarter financial results press release, and hold a conference call regarding those results, on August 5, 2021.

    Conference Call and Webcast Information

    Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on May 6, 2021, through 11:59 p.m. ET on May 10, 2021 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for international callers. The passcode for both the live call and the replay is 4283865. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentation" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and emerging coronaviruses, including SARS-CoV-2.

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta and now marketed by AbbVie as part of its leading treatment for chronic HCV infection, is sold under the brand names MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical programs in RSV, NASH and HBV, as well as discovery initiatives in SARS-CoV-2, RSV and hMPV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, HBV, HCV, COVID-19 and NASH; the discovery and development risks of Enanta's programs in RSV, HBV, NASH, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended December 31, 2020, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    UNAUDITED
    (in thousands, except per share amounts)
     
    Three Months Ended Six Months Ended
    March 31, March 31,

    2021

    2020

    2021

    2020

     
    Revenue

    $

    20,132

     

    $

    27,619

     

    $

    51,875

     

    $

    80,189

    Operating expenses
    Research and development

     

    41,506

     

     

    32,610

     

     

    78,171

     

     

    65,388

    General and administrative

     

    8,326

     

     

    6,884

     

     

    15,703

     

     

    13,805

    Total operating expenses

     

    49,832

     

     

    39,494

     

     

    93,874

     

     

    79,193

    Income (loss) from operations

     

    (29,700

    )

     

    (11,875

    )

     

    (41,999

    )

     

    996

    Other income, net

     

    545

     

     

    1,950

     

     

    1,222

     

     

    4,026

    Income (loss) before income taxes

     

    (29,155

    )

     

    (9,925

    )

     

    (40,777

    )

     

    5,022

    Income tax benefit

     

    7,110

     

     

    3,920

     

     

    10,404

     

     

    2,416

    Net income (loss)

    $

    (22,045

    )

    $

    (6,005

    )

    $

    (30,373

    )

    $

    7,438

    Net income (loss) per share
    Basic

    $

    (1.09

    )

    $

    (0.30

    )

    $

    (1.51

    )

    $

    0.37

    Diluted

    $

    (1.09

    )

    $

    (0.30

    )

    $

    (1.51

    )

    $

    0.36

    Weighted average common shares outstanding
    Basic

     

    20,171

     

     

    19,922

     

     

    20,131

     

     

    19,836

    Diluted

     

    20,171

     

     

    19,922

     

     

    20,131

     

     

    20,692

    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    UNAUDITED
    (in thousands)
     
    March 31, September 30,

    2021

    2020

    Assets
    Current assets
    Cash and cash equivalents

    $

    77,126

    $

    87,131

    Short-term marketable securities

     

    298,821

     

    299,518

    Accounts receivable

     

    20,132

     

    23,492

    Prepaid expenses and other current assets

     

    32,140

     

    26,696

    Total current assets

     

    428,219

     

    436,837

    Long-term marketable securities

     

    24,493

     

    32,634

    Property and equipment, net

     

    7,038

     

    8,596

    Deferred tax assets

     

    345

     

    345

    Operating lease, right-of-use assets

     

    6,972

     

    7,020

    Restricted cash

     

    608

     

    608

    Other long-term assets

     

    92

     

    92

    Total assets

    $

    467,767

    $

    486,132

    Liabilities and Stockholders' Equity
    Current liabilities
    Accounts payable

    $

    5,699

    $

    5,737

    Accrued expenses and other current liabilities

     

    15,744

     

    14,159

    Operating lease liabilities

     

    5,175

     

    4,261

    Total current liabilities

     

    26,618

     

    24,157

    Operating lease liabilities, net of current portion

     

    2,644

     

    3,838

    Series 1 nonconvertible preferred stock

     

    1,479

     

    1,479

    Other long-term liabilities

     

    994

     

    1,078

    Total liabilities

     

    31,735

     

    30,552

    Total stockholders' equity

     

    436,032

     

    455,580

    Total liabilities and stockholders' equity

    $

    467,767

    $

    486,132

     

    View Full Article Hide Full Article
  12. Positive Data from First Two Dose Cohorts: 200 mg and 400 mg of EDP-514

    EDP-514 was Safe and Well-Tolerated with Pharmacokinetics Supportive of Once Daily Dosing

    Patients Dosed with EDP-514 for 28 Days Showed a Mean Reduction in HBV RNA of 1 Log

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced positive data from the first two dose cohorts of Part 2 of its Phase 1b study of EDP-514 in chronic hepatitis B virus (HBV) patients already being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, the Company's novel class II oral HBV core inhibitor, was safe and well-tolerated…

    Positive Data from First Two Dose Cohorts: 200 mg and 400 mg of EDP-514

    EDP-514 was Safe and Well-Tolerated with Pharmacokinetics Supportive of Once Daily Dosing

    Patients Dosed with EDP-514 for 28 Days Showed a Mean Reduction in HBV RNA of 1 Log

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced positive data from the first two dose cohorts of Part 2 of its Phase 1b study of EDP-514 in chronic hepatitis B virus (HBV) patients already being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, the Company's novel class II oral HBV core inhibitor, was safe and well-tolerated, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in a mean reduction in HBV RNA of 1 log.

    "These positive clinical trial results from the 200 mg and 400 mg cohorts are very encouraging and support the continued advancement of EDP-514 as a potential treatment for HBV," said Nathalie Adda, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. "We are particularly encouraged by the emerging safety and tolerability profile of EDP-514 in combination with NUC treatment, which could provide a foundation for a combination therapy approach to achieve functional cures in patients with chronic HBV infection. We look forward to progressing our clinical program for EDP-514 and completing the 800 mg cohort, as well as reporting data on our ongoing Phase 1b study in viremic patients later this quarter, which will provide key information about the impact of EDP-514 on HBV DNA levels.

    The randomized, double-blind, placebo-controlled Phase 1b study is Part 2 of a Phase 1a/1b study assessing the safety, tolerability, PK and antiviral activity of three doses of EDP-514 in 24 NUC-suppressed chronic HBV patients who were either HBeAg-positive or HBeAg-negative. Patients were randomized to receive 200 mg (n=6), 400 mg (n=6), 800 mg (n=6) of EDP-514 or placebo (n=6) daily for 28 days. The 800 mg cohort is ongoing and final study results will be presented at a future scientific conference.

    In the 16 patients randomized in the first two dose cohorts, the majority of patients were HBeAg-negative and treated with tenofovir. EDP-514 was safe and well-tolerated and pharmacokinetics were supportive of once daily dosing, consistent with what was observed in Part 1 in healthy subjects. EDP-514 exposure increased linearly with dose, achieving trough concentrations up to 18-fold the protein-adjusted EC50. No liver enzyme elevations or other laboratory abnormalities were reported and no grade 3 or serious adverse events (AEs) occurred during the treatment period and the 4-week follow-up. Six of 12 patients given EDP-514 had at least one grade 1 or 2 AE during treatment. One patient dosed with 200 mg of EDP-514 had upper abdominal pain, a grade 2 AE, that led to study drug discontinuation.

    A mean reduction in HBV RNA of 1 log was observed in patients dosed with EDP-514 compared to 0.3 log in the placebo group after 28 days of treatment, which is similar to reported results for other HBV core inhibitors. A maximum reduction of 2.3 log (HBeAg-negative) and 2.8 log (HBeAg-positive) was observed in patients receiving EDP-514 as compared with a maximum 1.2 log reduction in those receiving placebo. As expected, the HBV DNA assessment did not show any change from baseline as these patients already had suppressed HBV DNA levels from NUC therapy. Additionally, no virologic failure or breakthrough was observed and as expected there were no changes in HBsAg, HBeAg, or HBcrAg levels.

    In Part 1 of the Phase 1a/1b study, EDP-514 was studied in healthy subjects who received single or multiple doses for up to 14 days. EDP-514 was well tolerated and demonstrated a favorable safety profile. Treatment-emergent AEs were infrequent and mild in intensity. No patients discontinued EDP-514 due to an AE. Additionally, the pharmacokinetic profile was supportive of once-daily dosing.

    About EDP-514

    EDP-514 is Enanta's lead HBV core inhibitor candidate. Core inhibitors, also known as capsid assembly modulators or core protein allosteric modulators, are a novel class of HBV replication inhibitors that have been shown to act at multiple steps in the HBV lifecycle. Preclinical data demonstrate that EDP-514 is a potent inhibitor of HBV replication and prevents the de novo formation of new HBV cccDNA in primary human hepatocytes when given early during HBV infection. In vitro data also show that EDP-514 is pan-genotypic, and that combinations of EDP-514 with a NUC, the current anti-viral therapy for HBV, or with a class I core inhibitor, result in additive to synergistic antiviral effects. ln vivo models of EDP-514 demonstrate excellent efficacy with greater than 4-log viral load reduction in HBV-infected PXB mice.

    About Hepatitis B Virus

    Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The virus is most commonly transmitted from mother to child during birth and delivery, as well as through contact with blood or other body fluids. It is estimated that over 290 million people worldwide have chronic HBV infection.1 Current approaches to treatment include interferon therapy and/or NUCs. Treatment with interferon offers poor cure rates and is accompanied by serious side effects.2 NUCs can be very effective at suppressing the virus but rarely result in full eradication of the virus from the liver.3

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of EDP-514 for hepatitis B virus (HBV). Statements that are not historical facts, are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta's research and development pipeline, such as HBV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HBV; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2020 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    1https://pubmed.ncbi.nlm.nih.gov/29599078/

    2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5401664/

    3https://pubmed.ncbi.nlm.nih.gov/30342034/

    View Full Article Hide Full Article
  13. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating and developing small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal second quarter ended March 31, 2021, after the U.S. markets close on May 6, 2021. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on the company's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating and developing small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal second quarter ended March 31, 2021, after the U.S. markets close on May 6, 2021. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on the company's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on May 6, 2021, through 11:59 p.m. ET on May 10, 2021 by dialing 855-859-2056 from the U.S. or 404-537-3406 for international callers. The passcode for both the live call and the replay is 4283865. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentation" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

     

    View Full Article Hide Full Article
  14. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will present at three upcoming virtual investor conferences:

    • H.C. Wainwright & Co. Global Life Sciences Conference: Corporate presentation available for on-demand viewing on Tuesday, March 9, 2021
    • 33rd Annual Roth Conference: Panel presentation "Therapies and Vaccines in the Fight Against COVID-19" on Monday, March 15, 2021 at 3:00 p.m. ET and corporate presentation available for on-demand viewing on Tuesday, March 9, 2021
    • Oppenheimer & Co. 31st Annual Healthcare Conference: Corporate presentation

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will present at three upcoming virtual investor conferences:

    • H.C. Wainwright & Co. Global Life Sciences Conference: Corporate presentation available for on-demand viewing on Tuesday, March 9, 2021
    • 33rd Annual Roth Conference: Panel presentation "Therapies and Vaccines in the Fight Against COVID-19" on Monday, March 15, 2021 at 3:00 p.m. ET and corporate presentation available for on-demand viewing on Tuesday, March 9, 2021
    • Oppenheimer & Co. 31st Annual Healthcare Conference: Corporate presentation on Tuesday, March 16, 2021 at 8:00 a.m. ET

    Webcasts of each event will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of each webcast will be available following the presentations and will be archived for approximately 90 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  15. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will present at the SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 8:40 am ET.

    A live webcast of the presentation will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 90 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will present at the SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 8:40 am ET.

    A live webcast of the presentation will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 90 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
    • Broadened Hepatitis B Virus (HBV) Program with EDP-721, a New Oral HBV RNA Destabilizer, as a Potential Component of a Functional HBV Cure Regimen; Plan to Initiate Phase 1 Study Mid-2021
    • Initiated RSVTx, a Phase 2b Study of EDP-938 in Adult Hematopoietic Cell Transplant Recipients with Acute Respiratory Syncytial Virus (RSV) Infection
    • Expanded RSV Program with a Discovery Initiative for Novel RSV L-Protein Inhibitors
    • Royalty Revenue for the Quarter was $31.7 Million
    • Cash and Marketable Securities Totaled $404.7 Million at December 31, 2020

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results…

    • Broadened Hepatitis B Virus (HBV) Program with EDP-721, a New Oral HBV RNA Destabilizer, as a Potential Component of a Functional HBV Cure Regimen; Plan to Initiate Phase 1 Study Mid-2021
    • Initiated RSVTx, a Phase 2b Study of EDP-938 in Adult Hematopoietic Cell Transplant Recipients with Acute Respiratory Syncytial Virus (RSV) Infection
    • Expanded RSV Program with a Discovery Initiative for Novel RSV L-Protein Inhibitors
    • Royalty Revenue for the Quarter was $31.7 Million
    • Cash and Marketable Securities Totaled $404.7 Million at December 31, 2020

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal first quarter ended December 31, 2020.

    "Our first fiscal quarter of 2021 was an especially active time, as we advanced and expanded our wholly-owned pipeline. In HBV, not only did we advance our two ongoing Phase 1b trials of EDP-514, but we also broadened our program with the introduction of EDP-721, a novel HBV RNA destabilizer. We believe that an all-oral regimen of EDP-514, EDP-721 and a nucleos(t)ide reverse transcriptase inhibitor has the potential to lead to a functional cure. We anticipate having preliminary data in our two existing HBV trials in the second quarter of 2021, with a Phase 1 study of EDP-721 on track to initiate mid-year," stated Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals.

    "We also made meaningful progress on our RSV franchise, initiating an RSV L-protein inhibitor discovery effort centered on potent nanomolar leads active against both RSV-A and RSV-B. Further, we initiated the Phase 2b RSVTx study evaluating EDP-938 in adult hematopoietic cell transplant recipients with RSV, and remain on track to initiate the Phase 2 RSVPEDs study of EDP-938 in pediatric patients with RSV this quarter. Meanwhile, we are in the process of expanding clinical sites for RSVP in Europe and Asia Pacific, so that we are ready when RSV re-emerges. Additionally, we are making significant progress in our discovery efforts in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19), with the goal of identifying two clinical candidates this year from among our hMPV, COVID-19 and RSV discovery programs. Importantly, our strategy for COVID-19 involves targeting mechanisms that should be effective against emerging spike protein variants," continued Dr. Luly.

    "Finally, our non-alcoholic steatohepatitis (NASH) program is progressing with the ARGON-2 trial of EDP-305 and the Phase 1 study of EDP-297 ongoing, and we look forward to having valuable insights around mid-year to inform next steps for our NASH program. Looking ahead, we believe the upcoming year will be important for Enanta, as we progress through numerous milestones across our entire pipeline."

    Fiscal First Quarter Ended December 31, 2020 Financial Results

    Total revenue for the three months ended December 31, 2020 was $31.7 million and consisted entirely of royalty revenue from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimens. For the three months ended December 31, 2019, total royalty revenue was $52.6 million on AbbVie's higher HCV sales. As reported by AbbVie, continued lower HCV product sales were due primarily to lower treated patient volumes during the COVID-19 pandemic.

    Research and development expenses totaled $36.7 million for the three months ended December 31, 2020, compared to $32.8 million for the three months ended December 31, 2019. The increase was primarily due to the timing of the company's clinical trials year over year.

    General and administrative expenses totaled $7.4 million for the three months ended December 31, 2020, compared to $6.9 million for the three months ended December 31, 2019. This increase was primarily due to increased headcount and compensation expense.

    Enanta recorded an income tax benefit of $3.3 million for the three months ended December 31, 2020 compared to income tax expense of $1.5 million for the same period in 2019. Enanta recorded an income tax benefit during the three months ended December 31, 2020 due to the provision of the CARES Act of 2020, which enables the Company to carry back its projected current year tax loss to offset taxable income in prior years.

    Net loss for the three months ended December 31, 2020 was $8.3 million, or a loss of $0.41 per diluted common share, compared to net income of $13.4 million, or $0.65 per diluted common share, for the corresponding period in 2019.

    Enanta's cash, cash equivalents and short-term and long-term marketable securities totaled $404.7 million at December 31, 2020. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its continuing royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.

    Pipeline Programs and Near-Term Milestones

    Virology

    • RSV: N-Protein Inhibitor EDP-938

    - RSVP, a Phase 2b randomized, double-blind, placebo-controlled study in 70 adult outpatients with community-acquired RSV infection, is ongoing, but to date the 2021 RSV season in the Northern Hemisphere has not yet begun due to COVID-19 mitigation measures. Enanta has made extensive efforts to more than double its clinical sites globally, including sites across Europe and Asia-Pacific, to be ready when RSV re-emerges.

    - Initiated RSVTx, a Phase 2b randomized, double-blind, placebo-controlled study in 200 adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection.

    - On schedule to initiate RSVPEDs, a Phase 2 randomized, double-blind, placebo-controlled study in 90 hospitalized and non-hospitalized pediatric RSV patients in the first quarter of calendar 2021.

    • HBV: Core Inhibitor EDP-514 and RNA Destabilizer EDP-721

    - Introduced EDP-721, a potent and selective HBV RNA destabilizer, for use alone or in combination with other mechanisms, such as EDP-514, with the goal of achieving an all-oral functional cure. Enanta expects to initiate a Phase 1 clinical study of EDP-721 in mid-2021.

    - Phase 1b study of EDP-514 in viremic HBV patients is ongoing, with preliminary data expected in the second quarter of calendar 2021.

    - Phase 1b study of EDP-514 in NUC-suppressed HBV patients is ongoing, with preliminary data expected in the second quarter of calendar 2021.

    • Respiratory Virology Discovery Programs – In 2021, Enanta expects to identify clinical development candidates for two of its three programs below:

    - RSV L-Protein Inhibitor

    °   Recently announced an RSV L-inhibitor discovery initiative with potent nanomolar leads active against both RSV-A and RSV-B, for potential use alone or in combination with agents targeting other RSV mechanisms, such as EDP-938.

    - COVID-19

    °   Urgently performing lead optimization on direct-acting antiviral leads targeting mechanisms that should be effective against emerging spike protein variants.

    - hMPV

    °   Continue performing lead optimization on current nanomolar hMPV inhibitor leads.

    NASH

    • Farnesoid X Receptor (FXR) Agonist EDP-305

    - Continue recruitment and dosing in ARGON-2 Phase 2b study of EDP-305, with a blinded 12-week interim analysis on a subset of patients, for Enanta's internal use, expected in mid-2021.

    • FXR Agonist EDP-297

    - Continue recruitment and dosing in a Phase 1 study of EDP-297, with data expected in mid-2021.

    Corporate

    • Announced the appointment of several key new hires, including

    - Tara Kieffer, Ph.D., Senior Vice President, New Product Strategy and Development;

    - Brendan Luu, Senior Vice President, Business Development; and

    - John DeVincenzo, M.D., Vice President, Translational Virology.

    Upcoming Events and Presentations

    • SVB Leerink Global Healthcare Conference (February 23-26, 2021, Virtual)
    • Enanta Annual Shareholder Meeting (March 2, 2021, Virtual)
    • H.C. Wainwright Global Life Sciences Conference (March 9-10, 2021, Virtual)
    • ROTH Capital Partners Annual Conference (March 15-17, 2021, Virtual)
    • Oppenheimer & Co. Annual Healthcare Conference (March 16-17, 2021, Virtual)
    • Enanta Fiscal Second Quarter 2021 Financial Results Webcast and Conference Call (May 6, 2021)

    Conference Call and Webcast Information

    Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on February 8, 2021, through 11:59 p.m. ET on February 12, 2021 by dialing 855-859-2056 from the U.S. or 404-537-3406 for international callers. The passcode for both the live call and the replay is 2854627. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical programs in RSV, HBV and NASH, as well as its discovery programs in SARS-CoV-2 and hMPV and prospects for future royalty revenue from sales of AbbVie's MAVYRET®/MAVIRET® regimen for HCV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, HBV, NASH, SARS-CoV-2 and hMPV; the discovery and development risks of Enanta's programs in RSV, HBV, NASH, SARS-CoV-2 and hMPV; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; the dependence of Enanta's revenues in the short-term upon AbbVie's sales of its MAVYRET/MAVIRET HCV regimen; any continuing impact of the COVID-19 pandemic on Enanta's royalty revenues, business operations and clinical trials; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year ended September 30, 2020, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

     
    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    UNAUDITED
    (in thousands, except per share amounts)
     
     
    Three Months Ended
    December 31,

     

    2020

     

     

    2019

     

     
    Revenue

    $

    31,743

     

    $

    52,570

     

    Operating expenses
    Research and development

     

    36,665

     

     

    32,778

     

    General and administrative

     

    7,377

     

     

    6,921

     

    Total operating expenses

     

    44,042

     

     

    39,699

     

    Income (loss) from operations

     

    (12,299

    )

     

    12,871

     

    Other income, net

     

    677

     

     

    2,076

     

    Income (loss) before income taxes

     

    (11,622

    )

     

    14,947

     

    Income tax (expense) benefit

     

    3,294

     

     

    (1,504

    )

    Net income (loss)

    $

    (8,328

    )

    $

    13,443

     

    Net income (loss) per share
    Basic

    $

    (0.41

    )

    $

    0.68

     

    Diluted

    $

    (0.41

    )

    $

    0.65

     

    Weighted average common shares outstanding
    Basic

     

    20,093

     

     

    19,751

     

    Diluted

     

    20,093

     

     

    20,773

     

     
    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    UNAUDITED
    (in thousands)
     

    December 31,

    September 30,

    2020

    2020

    Assets
    Current assets
    Cash and cash equivalents

    $

    55,095

    $

    87,131

    Short-term marketable securities

     

    331,101

     

    299,518

    Accounts receivable

     

    31,743

     

    23,492

    Prepaid expenses and other current assets

     

    28,003

     

    26,696

    Total current assets

     

    445,942

     

    436,837

    Long-term marketable securities

     

    18,462

     

    32,634

    Property and equipment, net

     

    7,788

     

    8,596

    Deferred tax assets

     

    345

     

    345

    Operating lease, right-of-use assets

     

    7,775

     

    7,020

    Restricted cash

     

    608

     

    608

    Other long-term assets

     

    92

     

    92

    Total assets

    $

    481,012

    $

    486,132

    Liabilities and Stockholders' Equity
    Current liabilities
    Accounts payable

    $

    6,305

    $

    5,737

    Accrued expenses and other current liabilities

     

    11,542

     

    14,159

    Operating lease liabilities

     

    5,197

     

    4,261

    Total current liabilities

     

    23,044

     

    24,157

    Operating lease liabilities, net of current portion

     

    3,520

     

    3,838

    Series 1 nonconvertible preferred stock

     

    1,479

     

    1,479

    Other long-term liabilities

     

    974

     

    1,078

    Total liabilities

     

    29,017

     

    30,552

    Total stockholders' equity

     

    451,995

     

    455,580

    Total liabilities and stockholders' equity

    $

    481,012

    $

    486,132

     

     

    View Full Article Hide Full Article
  16. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal first quarter ended December 31, 2020 after the U.S. markets close on February 8, 2021. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal first quarter ended December 31, 2020 after the U.S. markets close on February 8, 2021. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on February 8, 2021, through 11:59 p.m. ET on February 12, 2021 by dialing 855-859-2056 from the U.S. or 404-537-3406 for international callers. The passcode for both the live call and the replay is 2854627. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  17. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of Brendan Luu as Senior Vice President, Business Development and member of the company's senior management team. Mr. Luu brings more than 20 years of diversified business development and sales and marketing experience in the pharmaceutical and technology fields to Enanta, spanning a broad range of therapeutic areas, asset stages and deal structures.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210126005236/en/

    Brendan Luu, Senior Vice President, Business Development, Enanta Pharmaceuticals (Photo: Business Wire)

    Brendan Luu, Senior Vice President, Business Development, Enanta Pharmaceuticals…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of Brendan Luu as Senior Vice President, Business Development and member of the company's senior management team. Mr. Luu brings more than 20 years of diversified business development and sales and marketing experience in the pharmaceutical and technology fields to Enanta, spanning a broad range of therapeutic areas, asset stages and deal structures.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210126005236/en/

    Brendan Luu, Senior Vice President, Business Development, Enanta Pharmaceuticals (Photo: Business Wire)

    Brendan Luu, Senior Vice President, Business Development, Enanta Pharmaceuticals (Photo: Business Wire)

    "It is an ideal time to welcome Brendan to the Enanta team, particularly as we prepare for a catalyst-rich year, including data readouts, in our wholly owned pipeline of virology and liver disease treatment candidates," said Jay R. Luly, Ph.D., President and Chief Executive Officer. "In the coming year and continuing through the advancement of our clinical and preclinical programs, Brendan's insights and experience leading business development growth strategies will be tremendous assets to Enanta."

    "Enanta is an established leader in the discovery and development of virology and liver disease treatments. The company's product candidates for respiratory syncytial virus, hepatitis B virus and non-alcoholic steatohepatitis have transformative potential for the treatment of patients in these significant disease populations, and Enanta's discovery efforts in human metapneumovirus and SARS-CoV-2 are equally promising," said Brendan Luu. "I am eager to collaborate with the company's seasoned leadership team to continue their proven legacy of success and bring meaningful treatments to patients in need."

    Mr. Luu joins Enanta following 17 years at Merck KGaA, where he held roles of increasing responsibility. Most recently, he was Vice President and Global Head of Oncology Business Development, responsible for setting the franchise business development strategy and was accountable for its execution, including the completion of several major transactions across all stages of drug development in line with the company's R&D goals. Prior to assuming the role in 2018, Mr. Luu was Senior Director and Global Head of Business Development, Strategic Initiatives, where he led the strategy and partnering efforts to secure external financing for Merck KGaA's late-stage pipeline. Before that, Mr. Luu was Director, Global Licensing and Business Development, Neurology and Immunology, where he led in/out licensing transactions for preclinical and clinical-stage assets to support R&D in neurodegenerative diseases. Previously, he was an Associate Director of Regional Business Development, General Medicines responsible for growing the product portfolio in the Asia-Pacific region. Earlier in his career, he held various roles in the chemicals industry with BASF Corporation and in telecommunications with Tyco International, working in engineering, sales and marketing.

    Mr. Luu graduated magna cum laude from Drexel University with a B.S. in Chemical Engineering and Biology. He also holds an M.B.A. from the New York University Stern School of Business.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical development programs. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the discovery and development risks of Enanta's programs in RSV, NASH, HBV, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on Enanta's business operations and clinical trials; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year ended September 30, 2020, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    View Full Article Hide Full Article
    • Announces New Oral HBV RNA Destabilizer, EDP-721, as an Additional Component Toward Functional HBV Cure; Expects to Initiate Phase 1 Study Mid-2021
    • Expands RSV Program with Introduction of Discovery Initiative for RSV L-Inhibitors
    • Initiated RSVTx, a Phase 2b Study of EDP-938 in Adult Hematopoietic Cell Transplant Recipients with Acute RSV Infection
    • Strong Cash Balance of $419 Million at September 30, 2020 Supports Expanding Research and Development Programs

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., Enanta's President and Chief Executive Officer, will provide an update…

    • Announces New Oral HBV RNA Destabilizer, EDP-721, as an Additional Component Toward Functional HBV Cure; Expects to Initiate Phase 1 Study Mid-2021
    • Expands RSV Program with Introduction of Discovery Initiative for RSV L-Inhibitors
    • Initiated RSVTx, a Phase 2b Study of EDP-938 in Adult Hematopoietic Cell Transplant Recipients with Acute RSV Infection
    • Strong Cash Balance of $419 Million at September 30, 2020 Supports Expanding Research and Development Programs

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., Enanta's President and Chief Executive Officer, will provide an update across its pipeline programs in virology and non-alcoholic steatohepatitis (NASH), including its newest candidate, EDP-721, a novel oral hepatitis B virus (HBV) RNA destabilizer and the expansion of its respiratory syncytial virus (RSV) platform with a new RSV-L inhibitor program, as well as provide an update on its plans for 2021 during Enanta's presentation at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021 at 8:20 a.m. ET.

    "Throughout 2020, Enanta made meaningful progress with the initiation of five clinical trials across our pipeline. We look forward to building on this momentum in 2021, starting with the introduction today of our newest HBV clinical candidate, EDP-721, a novel RNA destabilizer with the potential to reduce the production of multiple HBV proteins, which we believe could be a key component in achieving a functional cure in this indication," stated Jay R. Luly, President and Chief Executive Officer of Enanta Pharmaceuticals. "Robust pre-clinical data has demonstrated that EDP-721 has the potential to reduce HBsAg production with HBV pan-genomic activity and exhibits additive to synergistic activity with approved nucleoside therapies and with Enanta's HBV core inhibitor, EDP-514. These data give us the confidence to progress EDP-721 into a Phase 1 clinical study by mid-2021, bringing us one step closer to developing an all-oral, triple regimen that could be a functional cure for patients living with chronic HBV."

    "We are also excited about the expansion of our RSV program, highlighted by our new discovery of potent RSV L-inhibitors. We look forward to continuing our progress throughout 2021 with multiple milestones expected across our pipeline, including the initiation of our Phase 2 study of EDP-938 in pediatric patients with RSV this quarter, preliminary data from two Phase 1b studies of EDP-514 in HBV in the second quarter, and results from our Phase 1 study of EDP-297 in development for the treatment of NASH, also in the second quarter. Furthermore, we expect to have preliminary information from an initial interim analysis of our Phase 2b NASH study of EDP-305 around mid-year, which we will use to help with further internal assessment of our NASH program," continued Dr. Luly. "Overall, 2021 is shaping up to be an exciting, catalyst-heavy year for Enanta, and we believe we are well-positioned to extend our track record of success heading into the new year."

    During the presentation, Dr. Luly will discuss Enanta's pipeline program updates and expectations for 2021.

    Pipeline Programs Update and Review

    Virology

    Hepatitis B Virus

    • EDP-721, Enanta's newest clinical candidate, is a potent and selective HBV RNA destabilizer, which has demonstrated a robust reduction of viral transcripts in preclinical models, leading to reduced production of multiple HBV proteins, including HBV surface antigen (HBsAg) and e-antigen (HBeAg). By targeting HBV RNA, EDP-721 is expected to reduce HBsAg derived from both integrated and covalently-closed circular DNA (cccDNA). Since high levels of HBsAg are known to suppress innate and adaptive immune responses, which are believed to occur through multiple mechanisms, a sustained reduction of HBsAg is regarded as a key component of a functional cure for HBV. Enanta plans to develop EDP-721 for use alone or in combination with other mechanisms, such as EDP-514, with the ultimate goal of achieving a functional cure. Enanta expects to initiate a Phase 1 clinical study of EDP-721 in mid-2021.
    • EDP-514, Enanta's core inhibitor with Fast Track Designation from the FDA, is being developed in two Phase 1b studies for the treatment of HBV across different patient populations: subjects on treatment with a nucleos(t)ide reverse transcriptase inhibitor (NUC-suppressed patients), and chronic HBV subjects with high viral loads who are not currently on therapy (viremic patients). Preliminary data is expected for both trials in the second quarter of 2021.

    Respiratory Syncytial Virus

    • EDP-938, Enanta's N-protein inhibitor with Fast Track Designation from the FDA, is being evaluated in a broad clinical development program, consisting of three trials.
      • In December, Enanta initiated RSVTx, a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection. The company plans to enroll, within 72 hours of symptom onset, approximately 200 adult subjects 18 to 75 years of age, who will receive EDP-938 or placebo for 21 days. The primary endpoint is the incidence of lower respiratory tract complications within 28 days of enrollment, while secondary endpoints include change from baseline in RSV RNA viral load, safety and pharmacokinetics.
      • RSVP, a Phase 2b randomized, double-blind, placebo-controlled study in 70 adult outpatients with community-acquired RSV infection, is ongoing, but to date the 2021 RSV season in the Northern Hemisphere has not yet begun due to COVID-19 mitigation measures. Enanta has made extensive efforts to expand its clinical sites beyond North America, including sites across the EU and Asia-Pacific, to be ready when RSV infection arrives. The company will provide further guidance on trial completion once RSV becomes prevalent again.
      • RSVPEDs, a Phase 2 randomized, double-blind, placebo-controlled study in hospitalized and non-hospitalized pediatric RSV patients age 28 days to 24 months, is expected to initiate in early 2021.

    Virology Discovery ProgramsIn 2021, Enanta anticipates identifying development candidates for two of its three virology discovery programs listed below:

    Respiratory Syncytial Virus

    • The RSV L-protein is a viral RNA-dependent RNA polymerase that contains multiple enzyme activities required for RSV replication. Today, Enanta announced the expansion of its RSV program with the introduction of an RSV L-inhibitor discovery initiative that includes potent nanomolar leads active against both RSV-A and RSV-B. An RSV-L-inhibitor is not expected to have cross-resistance to other classes of inhibitors, and therefore can potentially be used alone or in combination with agents targeting other RSV mechanisms, such as EDP-938.

    Human Metapneumovirus (hMPV)

    • Enanta is developing nanomolar inhibitors of human metapneumovirus, a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma.

    SARS-CoV-2

    • Enanta is working to discover direct-acting antiviral drug candidates for patients infected with the novel coronavirus, SARS-CoV-2, using a combination of drug target screening and drug design. The company is focused on polymerase and protease inhibitors and is currently optimizing potent lead molecules.

    Non-Alcoholic Steatohepatitis

    • EDP-305, Enanta's lead farnesoid X receptor (FXR) agonist with Fast Track Designation from the FDA, is currently being evaluated in ARGON-2, a Phase 2b randomized, double-blind, placebo-controlled 72-week study of approximately 340 patients with biopsy-confirmed NASH with fibrosis, using doses of 1.5 mg and 2.0 mg. A 12-week interim analysis on a subset of patients for the company's internal assessment is planned for mid-year 2021.
    • EDP-297, Enanta's highly potent and targeted follow-on FXR agonist also being developed for the treatment of NASH with fibrosis, is currently being evaluated in an ongoing Phase 1 randomized, double-blind, placebo-controlled, first-in-human clinical trial. Enanta expects to report safety, tolerability and pharmacokinetics data in the second quarter of 2021.
    • Enanta plans to use the results of the Phase 1 study of EDP-297 and the 12-week interim analysis in ARGON-2 to prioritize both FXR agonist compounds and seek opportunities for development of one or both of them in combination with other mechanisms for NASH with fibrosis.

    Webcast Information

    Enanta's presentation will take place on January 12, 2021 at 8:20 a.m. ET. A live webcast of the presentation, as well as the question and answer breakout session that follows the presentation, will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcasts will be available following the presentation and will be archived for approximately 60 days.

    ABOUT ENANTA PHARMACEUTICALS, INC.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical programs in RSV, HBV and NASH, as well as its discovery programs in SARS-CoV-2 and hMPV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, HBV, NASH, SARS-CoV-2 and hMPV; the discovery and development risks of Enanta's programs in RSV, HBV, NASH, SARS-CoV-2 and hMPV; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on business operations and clinical trials; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year ended September 30, 2020, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    View Full Article Hide Full Article
  18. Brings More Than 30 Years of Clinical Research and Academic Expertise in Respiratory Syncytial Virus

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of John P. DeVincenzo, M.D. as Vice President of Translational Virology. In this role, Dr. DeVincenzo will provide leadership and direction for Enanta's pipeline of respiratory antiviral clinical development programs and be responsible for the strategic development and tactical implementation of the clinical studies for these programs. Dr. DeVincenzo brings more than 30 years of clinical research and academic experience to Enanta, predominantly…

    Brings More Than 30 Years of Clinical Research and Academic Expertise in Respiratory Syncytial Virus

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of John P. DeVincenzo, M.D. as Vice President of Translational Virology. In this role, Dr. DeVincenzo will provide leadership and direction for Enanta's pipeline of respiratory antiviral clinical development programs and be responsible for the strategic development and tactical implementation of the clinical studies for these programs. Dr. DeVincenzo brings more than 30 years of clinical research and academic experience to Enanta, predominantly focused on the pathogenesis of respiratory syncytial virus (RSV) in children and the development of therapeutic and prevention strategies for RSV and other respiratory viral diseases.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210105005335/en/

    John P. DeVincenzo, M.D. (Photo: Business Wire)

    John P. DeVincenzo, M.D. (Photo: Business Wire)

    "John is a strong addition to Enanta as he has played a significant role in nearly every RSV therapeutic advancement in the past several decades and has worked with multiple RSV antiviral and vaccine candidates from proof-of-concept to clinical trials," said Nathalie Adda, M.D., Senior Vice President and Chief Medical Officer at Enanta. "John's appointment to this newly-created role reflects our commitment to advancing our RSV program and developing treatments for other respiratory infections, such as COVID-19 and human metapneumovirus. His specialized experience in the development of RSV therapeutics will prove to be invaluable, and we are thrilled to welcome him to Enanta."

    "Enanta is at the forefront of developing the leading RSV antiviral program and I am eager to leverage my years of expertise to help bring lifesaving therapeutics to patients in need," stated Dr. DeVincenzo. "I am excited by the potential of EDP-938, a differentiated N-protein inhibitor that targets the virus' replication machinery and has demonstrated positive Phase 2a results in a human challenge study. With a robust clinical program underway, including three ongoing or planned trials, I am eager to work with the Enanta team to advance the RSV clinical program."

    Dr. DeVincenzo joins Enanta from Le Bonheur Children's Hospital in Memphis, Tennessee, where he was a practicing pediatric Infectious Diseases Specialist and Medical Director of Le Bonheur's Molecular Diagnostic and Virology Laboratories and Professor of Pediatrics and Professor of Microbiology, Immunology, and Biochemistry at the University of Tennessee College of Medicine. Throughout his career, Dr. DeVincenzo has conducted numerous clinical and translational trials refining the pathogenesis of RSV and defining the role of prevention and therapeutic applications of monoclonal antibodies targeting RSV in infants and the immune-suppressed. He and his colleagues demonstrated the first evidence that treating an established RSV infection in humans can lower the viral load and result in reduced disease.

    Dr. DeVincenzo has received numerous honors including induction into the Alpha Omega Alpha National Medical Honor Society (2009) and the Hero Healthcare Award for innovation (2008). He and his lab were recognized with an Interscience Conference on Antimicrobial Agents and Chemotherapy Program Award from the American Society for Microbiology for best research in the area of Therapy and Prevention of Microbial Pathogens for an abstract entitled "Development of a Human Experimental Infection Model of Respiratory Syncytial Virus." He was also named as a Porter Endowed Visiting Faculty Member at Massachusetts General Hospital, Department of Pediatrics, as well as The Mildred and Dr. Morris Michael Endowed Visiting Professor and Visiting Faculty Member at the National Children's Hospital.

    Dr. DeVincenzo has a B.S. in Biology from Stanford University and received his M.D. from Vanderbilt University School of Medicine. He completed his residency in Pediatrics at University of California, Los Angeles and a fellowship in Pediatric Infectious Disease at Boston Children's Hospital. Dr. DeVincenzo is the author of over 250 original published abstracts and papers on the pathogenesis of RSV in children.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical development programs in RSV and other respiratory infections. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the discovery and development risks of Enanta's programs in RSV, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on Enanta's business operations and clinical trials; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year ended September 30, 2020, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    View Full Article Hide Full Article
  19. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will make a formal presentation at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 8:20 a.m. Eastern Time. The presentation will include an update on Enanta's research and development programs and plans for 2021. A separate question and answer session will follow the presentation and will be webcast.

    A live audio webcast will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will make a formal presentation at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 8:20 a.m. Eastern Time. The presentation will include an update on Enanta's research and development programs and plans for 2021. A separate question and answer session will follow the presentation and will be webcast.

    A live audio webcast will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in SARS-CoV-2 (COVID-19) and human metapneumovirus (hMPV).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  20. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of Tara L. Kieffer, Ph.D. as Senior Vice President, New Product Strategy and Development. Dr. Kieffer brings over 20 years of virologic research and pharmaceutical industry experience to Enanta, with proven expertise in drug discovery and development, program management and business development, including having played significant roles in developing and launching medicines for infectious and rare diseases.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201208005288/en/

    Tara L. Kieffer, Ph.D. (Photo: Business Wire)

    Tara L. Kieffer…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of Tara L. Kieffer, Ph.D. as Senior Vice President, New Product Strategy and Development. Dr. Kieffer brings over 20 years of virologic research and pharmaceutical industry experience to Enanta, with proven expertise in drug discovery and development, program management and business development, including having played significant roles in developing and launching medicines for infectious and rare diseases.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201208005288/en/

    Tara L. Kieffer, Ph.D. (Photo: Business Wire)

    Tara L. Kieffer, Ph.D. (Photo: Business Wire)

    "Tara is joining Enanta at a pivotal time as the company is advancing its wholly owned pipeline of virology and liver disease treatments," stated Jay R. Luly, Ph.D., President and Chief Executive Officer. "In 2021 and beyond, we anticipate having multiple data readouts across our pipeline and are eager to leverage Tara's scientific expertise in infectious diseases, combined with her experience in business and product development, to maximize the opportunities. We welcome her to the company, and to the senior management team, where we look forward to her contributions to advance our programs."

    "I am truly impressed with Enanta's commitment to becoming a leader in creating small molecule drugs for the treatment of viral and liver diseases by building on years of antiviral drug discovery and development expertise and prior successes helping to discover two marketed products for the treatment of chronic Hepatitis C infection," stated Dr. Kieffer. "Enanta has a robust and growing internal portfolio and I am excited to collaborate with the experienced team to accelerate the company's growth to bring meaningful new treatments to patients."

    Dr. Kieffer joins Enanta from Vertex Pharmaceuticals where she held roles of increasing responsibility. Most recently, she was Vice President, External Innovation, Business Development where she was responsible for assessing the external innovation landscape and leading projects aimed at identifying in-licensing and acquisition opportunities. Prior to that, she was Vice President, Integrated Program Management where she oversaw Vertex's internal development pipeline and marketed products. Previously, she was Senior Director, Chief of Staff to the Chief Medical Officer, supporting strategy and operations across Global Medicines Development and Affairs. Earlier in her career, Dr. Kieffer was Director, Clinical Biomarkers within the Translational and Medical Sciences Department. Prior to that role, she was Head of Clinical Virology, where she built and led a team responsible for laboratory and clinical research studies to understand the development of antiviral drug resistance to Hepatitis C and influenza viruses.

    Before joining Vertex, Dr. Kieffer was at Johns Hopkins University School of Medicine in the Department of Molecular Biology and Genetics, where her research studies focused on ongoing replication in patients with well-suppressed Human Immunodeficiency Virus infection.

    Dr. Kieffer graduated summa cum laude from Colgate University with a B.A. in Molecular Biology. She holds a Ph.D. in Immunology from Johns Hopkins University School of Medicine. She is co-author on more than 50 publications and an inventor on multiple patents involving treatments for Hepatitis C.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical development programs. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the discovery and development risks of Enanta's programs in RSV, NASH, HBV, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on Enanta's business operations and clinical trials; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-K for the fiscal year ended September 30, 2020, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    View Full Article Hide Full Article
  21. Webcast and Conference Call Today at 4:30 p.m. ET

    • On track to initiate a Phase 2b study in adult transplant patients with respiratory syncytial virus by year-end and a Phase 2 study in pediatric patients with respiratory syncytial virus in early 2021
    • Readouts from two clinical trials in hepatitis B virus program expected in the second quarter of 2021
    • Initiated Phase 1 study of EDP-297, a highly potent and targeted follow-on farnesoid X receptor agonist for the treatment of non-alcoholic steatohepatitis; initial clinical data expected in the second quarter of 2021
    • Royalty revenue for the quarter was $23.6 million
    • Cash and marketable securities totaled approximately $419 million at September 30, 2020

    Enanta Pharmaceuticals, Inc…

    Webcast and Conference Call Today at 4:30 p.m. ET

    • On track to initiate a Phase 2b study in adult transplant patients with respiratory syncytial virus by year-end and a Phase 2 study in pediatric patients with respiratory syncytial virus in early 2021
    • Readouts from two clinical trials in hepatitis B virus program expected in the second quarter of 2021
    • Initiated Phase 1 study of EDP-297, a highly potent and targeted follow-on farnesoid X receptor agonist for the treatment of non-alcoholic steatohepatitis; initial clinical data expected in the second quarter of 2021
    • Royalty revenue for the quarter was $23.6 million
    • Cash and marketable securities totaled approximately $419 million at September 30, 2020

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal fourth quarter and year ended September 30, 2020.

    "2020 was marked by significant progress for Enanta. We initiated four clinical trials between our hepatitis B and non-alcoholic steatohepatitis programs, and we announced two new discovery programs for respiratory viruses – SARS-CoV-2 and human metapneumovirus. Additionally, we remain on schedule to initiate our adult transplant Phase 2b study in RSV by year-end 2020, which will be followed shortly thereafter with the initiation of our pediatric Phase 2 study in RSV in early 2021," commented Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta. "I am grateful to the entire Enanta team for rising to the challenges presented by the COVID-19 pandemic and advancing our existing pipeline. Our commitment has laid the groundwork for a strong 2021, with multiple catalysts anticipated next year, including clinical data in our lead disease areas. If positive, these data will strengthen Enanta as a leader in the discovery and development of small molecule drugs for viral infections and liver diseases, and position us well to progress further our wholly-owned pipeline of clinical and preclinical programs to bring meaningful new treatments to patients."

    FISCAL FOURTH QUARTER AND YEAR ENDED SEPTEMBER 30, 2020 FINANCIAL RESULTS

    Total revenue of $23.6 million for the three months ended September 30, 2020 consisted of royalty revenue derived primarily from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir). Total revenue for the three months ended September 30, 2019, was $51.3 million. For the twelve months ended September 30, 2020, total revenue was $122.5 million compared to $205.2 million for the same period in 2019. The decrease in royalty revenue quarter over quarter was driven by lower HCV product sales as treated patient volumes have remained below pre-COVID levels, as reported by AbbVie.

    Research and development expenses were $36.7 million for the three months ended September 30, 2020, compared to $38.7 million for the three months ended September 30, 2019. For the twelve months ended September 30, 2020, research and development costs were $136.8 million compared to $142.2 million in 2019. The decrease in research and development expenses was primarily due to the timing of the company's clinical studies year over year and COVID-19-related delays in two clinical studies that are now ongoing.

    General and administrative expenses totaled $6.7 million for the three months ended September 30, 2020, compared to $6.2 million for the three months ended September 30, 2019. For the twelve months ended September 30, 2020, general and administrative costs were $27.4 million compared to $26.2 million in 2019.

    Enanta recorded income tax expense of $10.7 million for the three months ended September 30, 2020, despite a net operating loss, compared to an income tax benefit of $0.5 million for the same period in 2019. For the twelve months ended September 30, 2020, Enanta recorded income tax expense of $1.1 million, compared to an income tax benefit of $0.8 million for the twelve months ended September 30, 2019. The income tax expense in 2020 was due to a tax valuation allowance charge of $18.3 million recorded against the company's deferred tax assets in the three months ended September 30, 2020. This is a non-cash charge based on an assessment that it is more likely than not that Enanta's deferred tax assets will not be fully realized. The tax valuation allowance charge, which is recorded in income tax expense, was partially offset by a federal net operating loss carryback under the CARES Act, research and development credits generated during the year, and a release of an uncertain tax position reserve related to the close of a Massachusetts Department of Revenue Audit. In 2019, the company's income tax benefit was the result of a federal tax benefit on foreign derived royalty income and tax deductions from employee stock-award-related activity during 2019.

    Net loss for the three months ended September 30, 2020 was $29.3 million, or a loss of $1.46 per diluted common share, compared to net income of $9.2 million, or $0.44 per diluted common share, for the corresponding period in 2019. For the twelve months ended September 30, 2020, net loss was $36.2 million, or a loss of $1.81 per diluted common share, compared to net income of $46.4 million, or $2.21 per diluted common share for the twelve months ended September 30, 2019. The decrease in net income in both 2020 periods was due to a decrease in HCV royalties earned under the AbbVie agreement and a non-cash tax valuation allowance charge of $18.3 million recorded in the three months ended September 30, 2020.

    Enanta's cash, cash equivalents and marketable securities totaled approximately $419 million at September 30, 2020. This compares to a total of approximately $400 million at September 30, 2019. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its continuing royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.

    FINANCIAL GUIDANCE FOR FISCAL YEAR 2021

    • Research and Development Expense: $145 million to $165 million
    • General and Administrative Expense: $27 million to $33 million

    PIPELINE PROGRAMS AND BUSINESS REVIEW

    Virology

    Respiratory Syncytial Virus (RSV)

    Enanta is evaluating EDP-938, its N-protein inhibitor, in a broad clinical development program, consisting of three planned or ongoing trials: RSVP, RSVTx and RSVPEDs. Together, these studies are designed to evaluate the effect of EDP-938 in a range of pediatric and adult patient populations:

    • RSVP, an ongoing Phase 2b study in adult outpatients with community-acquired RSV infection, is anticipated to readout data in 3Q 2021, subject to the impact of the ongoing COVID-19 pandemic on levels of community RSV infection and activities at trial sites.
    • RSVTx, a Phase 2b study in adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract, is expected to initiate in 4Q 2020.
    • RSVPEDs, a Phase 2 study in hospitalized and non-hospitalized pediatric patients with RSV, is expected to initiate in early 2021.

    Human Metapneumovirus (hMPV)

    In January, Enanta announced a new program to develop nanomolar inhibitors of hMPV, a pathogen that causes upper and lower respiratory tract infections in young children and the elderly, as well as in immunocompromised patients or those with COPD or asthma. Enanta's goal is to finalize a clinical candidate in 2021.

    SARS-CoV-2 (COVID-19)

    In March, Enanta initiated a program to discover direct-acting antiviral drug candidates, with a focus on polymerase and protease inhibitors, for the treatment of patients infected with the novel coronavirus COVID-19, also known as SARS-CoV-2. Enanta's goal is to finalize a clinical candidate in 2021.

    Hepatitis B Virus (HBV)

    EDP-514, Enanta's novel class II core inhibitor with Fast Track Designation from the FDA, is being developed in two Phase 1b studies for the treatment of HBV across different patient populations: subjects treated with a nucleos(t)ide reverse transcriptase inhibitor (NUC-suppressed patients), and chronic HBV subjects with high viral loads and not currently on therapy (viremic patients):

    • In February, Enanta announced positive results from Part 1 of a Phase 1a/1b clinical study, informing the company's decision to initiate a Phase 1b study in NUC-suppressed patients in March. The Phase 1b study is currently ongoing with preliminary data expected in 2Q 2021.
    • Subsequently, in July, Enanta initiated a randomized, double-blind, placebo-controlled Phase 1b study in viremic chronic HBV subjects not currently on therapy, with preliminary data expected in 2Q 2021.

    Non-Alcoholic Steatohepatitis (NASH)

    EDP-305, Enanta's lead farnesoid X receptor (FXR) agonist, is currently being evaluated for the treatment of NASH with fibrosis:

    • In May, Enanta announced that it was no longer pursuing an indication for EDP-305 in primary biliary cholangitis and would remain focused on NASH for this compound.
    • In August, Enanta began enrollment for ARGON-2, its Phase 2b randomized, double-blind, placebo-controlled 72-week study of EDP-305 in approximately 340 patients with biopsy-confirmed NASH with fibrosis, using doses of 1.5 mg and 2.0 mg.

    EDP-297, Enanta's highly potent and targeted follow-on FXR agonist is currently being developed for the treatment of NASH with fibrosis:

    • A Phase 1 randomized, double-blind, placebo-controlled, first-in-human clinical trial of EDP-297 is ongoing. Enanta expects to report safety, tolerability and pharmacokinetics data in 2Q 2021.

    Around mid-year Enanta expects that the EDP-297 data, together with an interim analysis at 12 weeks of treatment on a subset of patients in ARGON-2, will enhance Enanta's ability to prioritize its FXR agonist compounds and seek opportunities for development of one or both of them in combinations with other mechanisms for NASH with fibrosis.

    UPCOMING EVENTS AND PRESENTATIONS

    • Piper Sandler 32nd Annual Virtual Healthcare Conference, November 30 - December 3, 2020
    • Evercore ISI 3rd Annual Virtual HealthCONx Conference, December 1 - 3, 2020
    • 39th Annual JP Morgan Virtual Healthcare Conference, January 11 - 14, 2021
    • Enanta plans to issue its fiscal first quarter 2021 financial results press release, and hold a conference call regarding those results, on February 8, 2021.

    CONFERENCE CALL AND WEBCAST INFORMATION

    Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on November 23, 2020, through 11:59 p.m. ET on November 25, 2020 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for international callers. The passcode for both the live call and the replay is 5436807. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    ABOUT ENANTA PHARMACEUTICALS, INC.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical programs in RSV, NASH and HBV, as well as Enanta's projections of its expenses in fiscal 2021, and its prospects for future royalty revenue from sales of AbbVie's MAVYRET®/MAVIRET® regimen for HCV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the dependence of Enanta's revenues in the short-term upon the continued success of AbbVie's sales of its MAVYRET/MAVIRET HCV regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, NASH, HBV, hMPV and SARS-CoV-2; treatment rates, competitive pricing, and reimbursement rate actions affecting MAVYRET/MAVIRET compared to competitive HCV products on the market; the discovery and development risks of Enanta's programs in RSV, NASH, HBV, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; any continuing impact of the COVID-19 pandemic on Enanta's HCV royalties, business operations and clinical trials; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended June 30, 2020, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    Tables to Follow

     
    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    UNAUDITED
    (in thousands, except per share amounts)
     
    Three Months Ended Twelve Months Ended
    September 30, September 30,

     

    2020

     

    2019

     

    2020

     

    2019

     
    Revenue

    $

    23,631

     

    $

    51,313

    $

    122,473

     

    $

    205,197

    Operating expenses
    Research and development

     

    36,686

     

     

    38,719

     

    136,756

     

     

    142,213

    General and administrative

     

    6,728

     

     

    6,163

     

    27,356

     

     

    26,246

    Total operating expenses

     

    43,414

     

     

    44,882

     

    164,112

     

     

    168,459

    Income (loss) from operations

     

    (19,783

    )

     

    6,431

     

    (41,639

    )

     

    36,738

    Other income, net

     

    1,149

     

     

    2,274

     

    6,620

     

     

    8,819

    Income (loss) before income taxes

     

    (18,634

    )

     

    8,705

     

    (35,019

    )

     

    45,557

    Income tax (expense) benefit

     

    (10,707

    )

     

    486

     

    (1,149

    )

     

    826

    Net income (loss)

    $

    (29,341

    )

    $

    9,191

    $

    (36,168

    )

    $

    46,383

    Net income (loss) per share
    Basic

    $

    (1.46

    )

    $

    0.47

    $

    (1.81

    )

    $

    2.37

    Diluted

    $

    (1.46

    )

    $

    0.44

    $

    (1.81

    )

    $

    2.21

    Weighted average common shares outstanding
    Basic

     

    20,074

     

     

    19,686

     

    19,940

     

     

    19,584

    Diluted

     

    20,074

     

     

    20,876

     

    19,940

     

     

    20,968

     
    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    UNAUDITED
    (in thousands)
     

    September 30,

    September 30,

    2020

    2019

    Assets
    Current assets
    Cash and cash equivalents

    $

    87,131

    $

    51,230

    Short-term marketable securities

     

    299,518

     

    284,006

    Accounts receivable

     

    23,492

     

    51,313

    Prepaid expenses and other current assets

     

    26,696

     

    15,299

    Total current assets

     

    436,837

     

    401,848

    Long-term marketable securities

     

    32,634

     

    65,013

    Property and equipment, net

     

    8,596

     

    10,927

    Deferred tax assets

     

    345

     

    11,341

    Operating lease, right-of-use assets

     

    7,020

     

    -

    Restricted cash

     

    608

     

    608

    Other long-term assets

     

    92

     

    92

    Total assets

    $

    486,132

    $

    489,829

    Liabilities and Stockholders' Equity
    Current liabilities
    Accounts payable

    $

    5,737

    $

    6,689

    Accrued expenses and other current liabilities

     

    14,159

     

    15,920

    Operating lease liabilities

     

    4,261

     

    -

    Total current liabilities

     

    24,157

     

    22,609

    Operating lease liabilities, net of current portion

     

    3,838

     

    -

    Series 1 nonconvertible preferred stock

     

    1,479

     

    1,628

    Other long-term liabilities

     

    1,078

     

    3,100

    Total liabilities

     

    30,552

     

    27,337

    Total stockholders' equity

     

    455,580

     

    462,492

    Total liabilities and stockholders' equity

    $

    486,132

    $

    489,829

     

    View Full Article Hide Full Article
  22. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in two upcoming conferences:

    • Evercore ISI 3rd Annual Virtual HealthCONx Conference, Fireside Chat at 9:15 a.m. ET on December 1, 2020
    • Piper Sandler 32nd Annual Virtual Healthcare Conference, One-on-One Meetings on December 2, 2020, with a Fireside Chat available to view beginning November 25

    To view each event, visit the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. Replays of each event will be archived for at least 30 days…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in two upcoming conferences:

    • Evercore ISI 3rd Annual Virtual HealthCONx Conference, Fireside Chat at 9:15 a.m. ET on December 1, 2020
    • Piper Sandler 32nd Annual Virtual Healthcare Conference, One-on-One Meetings on December 2, 2020, with a Fireside Chat available to view beginning November 25

    To view each event, visit the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. Replays of each event will be archived for at least 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  23. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal fourth quarter and year ended September 30, 2020 after the U.S. markets close on November 23, 2020. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information
    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal fourth quarter and year ended September 30, 2020 after the U.S. markets close on November 23, 2020. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 8:00 p.m. ET on November 23, 2020, through 11:59 p.m. ET on November 28, 2020 by dialing 855-859-2056 from the U.S. or 404-537-3406 for international callers. The passcode for both the live call and the replay is 5436807. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  24. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 4th Annual H.C. Wainwright Virtual NASH Investor Conference on October 5, 2020 at 2:00 pm ET.

    A live webcast of the fireside chat will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for at least 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 4th Annual H.C. Wainwright Virtual NASH Investor Conference on October 5, 2020 at 2:00 pm ET.

    A live webcast of the fireside chat will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for at least 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  25. -- Initial clinical data including safety, tolerability and pharmacokinetics expected in 2Q 2021 –

    Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subjects in its Phase 1 clinical trial of EDP-297, a highly potent and targeted follow-on farnesoid X receptor (FXR) agonist, being developed for the treatment of non-alcoholic steatohepatitis (NASH).

    "We are excited to advance our efforts in NASH and progress EDP-297, our follow-on FXR agonist, into clinical development," commented Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "In preclinical studies…

    -- Initial clinical data including safety, tolerability and pharmacokinetics expected in 2Q 2021 –

    Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subjects in its Phase 1 clinical trial of EDP-297, a highly potent and targeted follow-on farnesoid X receptor (FXR) agonist, being developed for the treatment of non-alcoholic steatohepatitis (NASH).

    "We are excited to advance our efforts in NASH and progress EDP-297, our follow-on FXR agonist, into clinical development," commented Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "In preclinical studies, EDP-297 demonstrated a compelling product profile, with a potency greater than that published on any FXR agonist in clinical development and high target-tissue distribution in the liver and intestine. Based on these data, we believe we may be able to effectively dose EDP-297 at lower doses and with reduced drug levels in non-targeted tissues, potentially improving tolerability by reducing pruritis. We look forward to reporting clinical data in the second quarter of 2021."

    The Phase 1, randomized, double-blind, placebo-controlled, first-in-human study is designed to assess the safety, tolerability, and pharmacokinetics, including the effect of food intake, of orally administered EDP-297 in approximately 74 healthy adult subjects. Two phases are planned: a single ascending dose phase enrolling six cohorts, including a two-part food effect cohort, and a multiple ascending dose phase enrolling three cohorts.

    In two recent poster presentations at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020, treatment with EDP-297 demonstrated significantly reduced fibrosis progression and improved liver function in a rat model of NASH. Additionally, in 3D NASH microtissues, EDP-297 modulated multiple pathways associated with the pathogenesis of NASH, including decreased expression of genes encoding multiple lipogenic and inflammatory proteins, and significantly reduced expression of inflammatory and fibrotic genes and normalized circulating markers of liver injury.

    About NASH and FXR

    NASH is a serious form of non-alcoholic fatty liver disease (NAFLD) which is common in the United States and around the world and is closely associated with diabetes and obesity. Characterized by an excessive build-up of fat in the liver causing stress and damage to liver cells, NASH can lead to inflammation and fibrosis, causing permanent damage, including cirrhosis and impaired liver function, as well as cancer and eventually death. NASH is the leading cause of liver transplants in the United States and Europe and currently has no FDA-approved treatment.1 A farnesoid X receptor is a main regulator of bile acid levels in the liver and small intestine. It responds to bile acids by regulating gene transcription of key enzymes and transporters, many of which play important roles in lipid metabolism, insulin resistance, inflammation and fibrosis.

    About EDP-297, a FXR Agonist

    EDP-297 is a potent FXR agonist and Enanta's follow-on FXR agonist candidate being developed for the treatment of NASH. EDP-297 represents a class of FXR agonists that has been designed to take advantage of increased binding interactions with the receptor. Preclinical findings of EDP-297 demonstrate potent anti-fibrotic, anti-inflammatory and hepatoprotective effects. EDP-297 has demonstrated preclinical potency greater than that published on any FXR agonist in clinical development today. Further, in preclinical models EDP-297 has been shown to be targeted to tissues important for efficacy, namely liver and intestine, versus plasma and skin.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of EDP-297 for NASH. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta's research and development pipeline, such as NASH; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for NASH; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended June 30, 2020 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    1 https://www.worldhepatitisalliance.org/latest-news/infohep/3548835/nash-fastest-growing-reason-liver-transplant-united-states

    View Full Article Hide Full Article
  26. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in three upcoming virtual conferences in September:

    • Baird 2020 Global Healthcare Conference, Fireside Chat at 9:40 a.m. ET on September 10, 2020
    • H.C. Wainwright 22nd Annual Global Investment Conference, Presentation at 1:00 p.m. ET on September 15, 2020
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, Presentation at 3:20 p.m. ET on September 22, 2020

    A live webcast of each of the above presentations will be accessible by visiting the "Events and Presentations" section…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in three upcoming virtual conferences in September:

    • Baird 2020 Global Healthcare Conference, Fireside Chat at 9:40 a.m. ET on September 10, 2020
    • H.C. Wainwright 22nd Annual Global Investment Conference, Presentation at 1:00 p.m. ET on September 15, 2020
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, Presentation at 3:20 p.m. ET on September 22, 2020

    A live webcast of each of the above presentations will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. Replays of the webcasts will be available following the presentations and will be archived for at least 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
    • New Pharmacokinetic and Safety Results from Phase 1a Study of HBV Core Inhibitor EDP-514, Highlighting Good Safety and Tolerability, and Pharmacokinetics Suitable for Once Daily Dosing
    • Phase 2a ARGON-1 Study for FXR Agonist EDP-305 Targeting NASH, Showing Significant Alanine Transaminase and Liver Fat Content Reduction
    • Preclinical Findings for Follow-on FXR Agonist EDP-297 Targeting NASH, Demonstrating Potent Anti-Fibrotic, Anti-Inflammatory and Hepatoprotective Effects

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that data from Enanta's wholly-owned development programs for non-alcoholic steatohepatitis…

    • New Pharmacokinetic and Safety Results from Phase 1a Study of HBV Core Inhibitor EDP-514, Highlighting Good Safety and Tolerability, and Pharmacokinetics Suitable for Once Daily Dosing
    • Phase 2a ARGON-1 Study for FXR Agonist EDP-305 Targeting NASH, Showing Significant Alanine Transaminase and Liver Fat Content Reduction
    • Preclinical Findings for Follow-on FXR Agonist EDP-297 Targeting NASH, Demonstrating Potent Anti-Fibrotic, Anti-Inflammatory and Hepatoprotective Effects

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that data from Enanta's wholly-owned development programs for non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV) will be presented at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

    Data presented include results from the Phase 1a clinical trial of EDP-514, Enanta's core inhibitor for HBV. Additionally, Enanta's NASH program will be discussed in an oral presentation detailing the Phase 2a ARGON-1 study of EDP-305, Enanta's lead Farnesoid X receptor (FXR) agonist, and two posters highlighting preclinical data on EDP-297, Enanta's follow-on FXR agonist.

    "We are pleased to share scientific data across multiple candidates in our pipeline, supporting our chemistry-driven approach to developing innovative treatments for viral infections and liver diseases," stated Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "The positive results from our first-in-human Phase 1a study of EDP-514, demonstrating a strong safety, tolerability and pharmacokinetic profile, gave us the confidence to advance our HBV program into two ongoing Phase 1b clinical studies in HBV patients. Additionally, the data presented for our NASH candidates further demonstrate the potential of both FXR agonists. EDP-305 shows statistically significant improvements in liver biochemistry and hepatic steatosis, and our follow-on NASH candidate EDP-297 demonstrates a potent anti-fibrotic effect."

    August 28, 2020, 12:15 PM - 12:30 PM CEST

    ASO78: "EDP-305, a Non-Bile Acid Farnesoid X Receptor (FXR) Agonist, Showed Statistically Significant Improvements in Liver Biochemistry and Hepatic Steatosis in the Phase 2a ARGON-1 Study," Vlad Ratziu, M.D., Ph.D., France

    This oral presentation highlights the final results at week 12 of the randomized, double-blind, placebo-controlled Phase 2a ARGON-1 trial. The study's primary endpoint was achieved with a statistically significant alanine transaminase (ALT) reduction of 28 U/L in the EDP-305 2.5mg arm versus 15 U/L in the placebo arm at week 12 (p=0.049). There was a statistically significant reduction in liver fat content with EDP-305 at the 2.5mg dose as measured by MRI-PDFF (p<0.001). EDP-305 also exhibited strong target engagement as shown by reductions in C4 and increases in FGF-19 and alkaline phosphatase (ALP). A robust gamma-glutamyl transferase (GGT) reduction was also observed. Overall, EDP-305 was generally safe, with the majority of treatment-emergent adverse events (TEAEs) being mild to moderate. In this study, mild to moderate pruritis was more frequent with the 2.5mg dose and there was a higher frequency of treatment discontinuation compared to the 1mg dose or placebo. Treatment with EDP-305 was associated with a modest effect on lipids as demonstrated by a minimal absolute change of 6 mg/dL, 5 mg/dL, and -4 mg/dL, with the 2.5mg dose, 1mg dose and placebo, respectively. These data warrant further development of EDP-305 in a NASH proven liver-biopsy patient population.

    August 28, 2020, 09:30 AM - 19:30 PM CEST

    FRI109: "EDP-297, a Novel and Potent FXR Agonist, Exhibits Robust Anti-Fibrotic Effects with Significant Liver Function Improvement in a Rat Model of Non-Alcoholic Steatohepatitis," Mozhdeh Sojoodi, Ph.D., United States

    Data in this poster demonstrate that treatment with EDP-297 significantly reduced fibrosis progression and improved liver function measured by key biomarkers in a rat model that closely resembles the human disease progression of NASH. Rats were randomized to receive either vehicle control (0.5% methylcellulose), 0.1 mg/kg EDP-297, or 0.3 mg/kg EDP-297 by once-daily oral gavage at the first signs of fibrosis (5 weeks, n=8 per group). EDP-297 demonstrated a highly statistically significant improvement in liver function as measured by a 78.9% reduction (p<0.001) in ALT, a 73.5% reduction (p<0.001) in aspartate aminotransferase (AST) and a 75.7% reduction (p<0.001) in total bilirubin. These results suggest that EDP-297 may have a potent anti-fibrotic effect in NASH patients, including those with late-stage F3/4 fibrosis.

    August 29, 2020, 09:30 AM - 19:30 PM CEST

    SAT042: "A Novel FXR Agonist EDP-297 Exerts Anti-Inflammatory and Hepatoprotective Effects in Human Liver 3D Microtissues and Rodent NASH and Liver Injury Models," Mary Chau, Ph.D., United States

    Data in this poster highlight the pharmacologic activity of EDP-297 as evaluated in multiple in vitro assays and further characterized in a human liver 3D microtissue system and in rodent models of NASH and liver injury. In 3D NASH microtissues, EDP-297 modulated multiple pathways associated with the pathogenesis of NASH. Specifically, decreased expression of genes encoding multiple lipogenic and inflammatory proteins was observed. EDP-297 treated rats with bile duct ligation showed significantly reduced expression of inflammatory and fibrotic genes and normalized circulating markers of liver injury, including ALT (76% reduction, p<0.001), AST (83% reduction, p<0.001) and GGT (76% reduction, p<0.001). Histological analysis confirmed the hepatoprotective effects of EDP-297 with reduced immune cell infiltration and necrosis. EDP-297 was shown to be hepatoprotective in a diet-induced obese NASH model in mice.

    August 29, 2020, 09:30 AM - 19:30 PM CEST

    SAT440: "EDP-514, a Novel Pangenotypic Class II Hepatitis B Virus Core Inhibitor: Final Results of a Phase 1 Study in Healthy Adult Subjects," Kajal Larson, Ph.D., United States

    Data in this poster present the safety and pharmacokinetic results of single ascending doses and multiple ascending doses of EDP-514 in a first-in-human, Phase 1 study. EDP-514 was rapidly absorbed and its exposure increased with escalating single and multiple dosing of 600 mg and 400 mg, respectively. EDP-514 was generally safe and well-tolerated over a broad range of single and multiple doses for up to 14 days, with all TEAEs being of mild severity. There were no severe or serious TEAEs and no discontinuations due to adverse events. Further, there were no significant individual lab data findings or pattern of lab abnormalities. EDP-514 exhibited pharmacokinetics suitable for once daily oral dosing. Following multiple dosing with EDP-514 when administered with and without a standard meal, the geometric mean plasma concentration at 24 hours (C24) was several fold higher than the in vitro serum protein adjusted EC50 (paEC50) of 71 ng/mL under fasted conditions (5.8- to 9.3-fold) and fed conditions (standard meal, 22.1-fold), suggesting that EDP-514 can be administered without regard to meals.

    EDP-514 is currently being studied in two ongoing Phase 1b clinical studies, in viremic HBV patients, and in HBV patients treated with a nucleos(t)ide reverse transcriptase inhibitor (NUC-suppressed patients). Enanta anticipates reporting preliminary safety and virologic data from the viremic study in the first half of 2021, and preliminary data in NUC-suppressed patients in the second quarter of 2021.

    The full scientific program for The Digital International Liver Congress 2020, as well as the abstracts, can be found at https://ilc-congress.eu/programme-digital-ilc-2020/.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further developments with respect to EDP-305 and EDP-297 for NASH and EDP-514 for HBV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta's research and development pipeline, such as NASH and HBV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for NASH and HBV; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended June 30, 2020 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    View Full Article Hide Full Article
  27. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that clinical data from Enanta's wholly-owned development programs for non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV) have been accepted for presentations at the European Association for the Study of the Liver (EASL) Digital International Liver Congress 2020 being held August 27-29, 2020.

    Clinical data will include an oral presentation of the Phase 2a ARGON-1 study of EDP-305, Enanta's Farnesoid X receptor (FXR) agonist for the treatment of NASH, as well as a poster on new Phase 1 data of EDP-514, Enanta's core inhibitor for HBV. Preclinical…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that clinical data from Enanta's wholly-owned development programs for non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV) have been accepted for presentations at the European Association for the Study of the Liver (EASL) Digital International Liver Congress 2020 being held August 27-29, 2020.

    Clinical data will include an oral presentation of the Phase 2a ARGON-1 study of EDP-305, Enanta's Farnesoid X receptor (FXR) agonist for the treatment of NASH, as well as a poster on new Phase 1 data of EDP-514, Enanta's core inhibitor for HBV. Preclinical data on EDP-297, Enanta's follow-on FXR agonist for NASH, will also be highlighted in two poster presentations.

    The full scientific program for The Digital International Liver Congress 2020, as well as the abstracts, can be found at https://ilc-congress.eu/programme-digital-ilc-2020/. Further details will be available at the time of these presentations.

    Oral Presentation:

    August 28, 2020, 12:15 - 12:30 CEST

    AS078: "EDP-305, A Non-Bile Acid Farnesoid X Receptor (FXR) Agonist, Showed Statistically Significant Improvements in Liver Biochemistry and Hepatic Steatosis in the Phase 2a ARGON-1 Study"

    Location: Channel 3

    Presenter: Vlad Ratziu, M.D., Ph.D., France

    Poster Presentations:

    August 28, 2020, 09:30 - 19:30 CEST

    FRI109: "EDP-297, A Novel and Potent FXR Agonist, Exhibits Robust Anti-Fibrotic Effects with Significant Liver Function Improvement in a Rat Model of Non-Alcoholic Steatohepatitis"

    Presenter: Mozhdeh Sojoodi, Ph.D., United States

    August 29, 2020, 09:30 - 19:30 CEST

    SAT042: "A Novel FXR Agonist EDP-297 Exerts Anti-Inflammatory and Hepatoprotective Effects in Human Liver 3D Microtissues and in Rodent Models of Liver Injury and NASH"

    Presenter: Mary Chau, Ph.D., United States

    August 29, 2020, 09:30 - 19:30 CEST

    SAT440: "EDP-514, a Novel Pangenotypic Class II Hepatitis B Virus Core Inhibitor: Final Results of a Phase 1 Study in Healthy Adult Subjects"

    Presenter: Kajal Larson, Ph.D., United States

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
    • Initiated Phase 1b Study of EDP-514 in Viremic HBV Patients and Resumed Phase 1b Study of EDP-514 in NUC-Suppressed HBV Patients; Preliminary Data Expected in 1H 2021 and 2Q 2021, Respectively
    • Plans to Initiate Two Phase 2 Studies of EDP-938 in Pediatric and Adult Transplant Patients with RSV in 4Q 2020
    • Initiated ARGON-2 Phase 2b Study of EDP-305 in Patients with NASH, On Track to Initiate Phase 1 Study of EDP-297 for NASH in 3Q 2020
    • Royalty Revenue for the Quarter was $18.7 Million
    • Cash and Marketable Securities Totaled $435.4 Million at June 30, 2020

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported…

    • Initiated Phase 1b Study of EDP-514 in Viremic HBV Patients and Resumed Phase 1b Study of EDP-514 in NUC-Suppressed HBV Patients; Preliminary Data Expected in 1H 2021 and 2Q 2021, Respectively
    • Plans to Initiate Two Phase 2 Studies of EDP-938 in Pediatric and Adult Transplant Patients with RSV in 4Q 2020
    • Initiated ARGON-2 Phase 2b Study of EDP-305 in Patients with NASH, On Track to Initiate Phase 1 Study of EDP-297 for NASH in 3Q 2020
    • Royalty Revenue for the Quarter was $18.7 Million
    • Cash and Marketable Securities Totaled $435.4 Million at June 30, 2020

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal third quarter ended June 30, 2020.

    "During the past quarter, Enanta made progress in our clinical development programs, laying the groundwork for several catalyst-rich quarters to come. Our virology programs, developed from years of antiviral drug discovery expertise, continue to advance with the initiation of our Phase 1b clinical trial in viremic HBV patients and the resumption of our Phase 1b study in HBV patients currently treated with nucleos(t)ide reverse transcriptase inhibitors, which was previously paused due to the COVID-19 pandemic," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "In addition, our Phase 2b RSVP trial in RSV is ongoing, and we are on schedule to initiate two additional studies for the condition, one in pediatric patients and a second in adult transplant patients, by year end. Finally, we are also excited about advancing our candidates in NASH this quarter, starting with the initiation of the ARGON-2 trial of EDP-305, our potent FXR agonist candidate, and the planned initiation later this quarter of the Phase 1 study of EDP-297, our highly potent and targeted follow-on FXR agonist."

    Fiscal Third Quarter Ended June 30, 2020 Financial Results

    Total revenue of $18.7 million for the three months ended June 30, 2020 consisted of royalty revenue derived primarily from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®. For the three months ended June 30, 2019, total revenue was $44.4 million, which consisted of royalty revenue earned on AbbVie's global net sales of its HCV regimens. AbbVie has stated that the decrease in royalty revenue in the three months ended June 30, 2020 was mainly driven by declining treated patient volumes due to the COVID-19 pandemic.

    Research and development expenses increased slightly to $34.7 million for the three months ended June 30, 2020, compared to $34.5 million for the three months ended June 30, 2019.

    General and administrative expenses totaled $6.8 million for the three months ended June 30, 2020, compared to $6.2 million for the three months ended June 30, 2019. The slight increase was due to an increase in compensation expense.

    Enanta recorded an income tax benefit of $7.1 million for the three months ended June 30, 2020 compared to an income tax benefit of $0.9 million for the same period in 2019. The income tax benefit in 2020 was driven by the company's net loss for the period, federal research and development tax credits, and a federal net operating loss carry back.

    Net loss for the three months ended June 30, 2020 was $14.3 million, or a loss of $0.71 per diluted common share, compared to net income of $7.0 million, or $0.33 per diluted common share, for the corresponding period in 2019.

    Enanta's cash, cash equivalents and marketable securities totaled $435.4 million at June 30, 2020. This compares to a total of $400.2 million at September 30, 2019, its fiscal year end. Enanta expects that its current cash, cash equivalents and short-term and long-term marketable securities, as well as its continuing royalty revenue, will continue to be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.

    Pipeline Programs and Near-term Milestones

    • Virology
      • Respiratory Syncytial Virus (RSV): N-Protein Inhibitor EDP-938
        • Phase 2b RSVP trial is ongoing at sites in the Southern Hemisphere and will expand to trial sites in Europe and North America for the fall and winter RSV season, with the goal of reporting data in 3Q 2021
        • Initiate Phase 2 dose-ranging study in pediatric patients with RSV in 4Q 2020
        • Initiate Phase 2 study in adult transplant patients with RSV in 4Q 2020
      • Hepatitis B (HBV): Core Inhibitor EDP-514
        • Initiated Phase 1b study in viremic HBV patients, with preliminary data expected in 1H 2021
        • Resumed Phase 1b study in NUC-suppressed HBV patients, with preliminary data expected in 2Q 2021
      • Human Metapneumovirus (hMPV)
        • Perform optimization of Enanta's current nanomolar hMPV inhibitor leads
      • SARS-CoV-2 (COVID-19)
        • Continue to advance efforts for discovery of direct-acting antiviral compounds for SARS-CoV-2
    • Non-Alcoholic Steatohepatitis (NASH)
      • Farnesoid X Receptor (FXR) Agonist EDP-305
        • Recruitment and dosing in ARGON-2 Phase 2b study of EDP-305 in NASH ongoing
      • FXR Agonist EDP-297
        • Initiate Phase 1 study of EDP-297 in 3Q 2020, with data expected in 2Q 2021
      • Advance efforts for discovery of non-FXR compounds for NASH
    • Corporate
      • Announced the appointment of Mark G. Foletta to Enanta's Board of Directors where he will serve as the Chair of the Audit Committee as well as a member of the Nominating and Corporate Governance Committee

    Upcoming Events and Presentations

    • August 10, 2020 – BTIG Virtual Biotechnology Conference 2020
    • September 9-10, 2020 – Baird 2020 Global Healthcare Conference
    • September 21-23, 2020 – Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    • Enanta plans to issue its fiscal fourth quarter financial results press release, and hold a conference call regarding those results, on November 23, 2020.

    Conference Call and Webcast Information

    Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on August 4, 2020, through 11:59 p.m. ET on August 6, 2020 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for international callers. The passcode for both the live call and the replay is 7561838. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical programs in RSV, NASH and HBV, as well as the prospects for advancing research in hMPV and SARS-CoV-2 and future royalty revenue to Enanta from sales of AbbVie's MAVYRET/MAVIRET regimen for HCV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the dependence of Enanta's revenues in the short-term upon the continued success of AbbVie's sales of its MAVYRET/MAVIRET HCV regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, NASH, HBV, hMPV and SARS-CoV-2; treatment rates, competitive pricing, and reimbursement rate actions affecting MAVYRET/MAVIRET compared to competitive HCV products on the market; the impact COVID-19 could have on number of patient treatments which could impact MAVYRET/MAVIRET sales; the discovery and development risks of Enanta's programs in RSV, NASH and HBV; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; the realizability of our deferred tax assets; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2020, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

     

    ENANTA PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    UNAUDITED

    (in thousands, except per share amounts)

               

    Three Months Ended

     

    Nine Months Ended

    June 30,

     

    June 30,

          

    2020

     

    2019

     

    2020

     

    2019

                        
    Revenue    

     $

         18,653

     

     

     $

         44,367

     

     $

         98,842

     

     

     $

       153,884

    Operating expenses            
    Research and development

     

             34,682

     

     

     

             34,461

     

     

          100,070

     

     

     

          103,494

    General and administrative

     

               6,823

     

     

     

               6,151

     

     

             20,628

     

     

     

             20,083

    Total operating expenses

     

             41,505

     

     

     

             40,612

     

     

          120,698

     

     

     

          123,577

    Income (loss) from operations

     

           (22,852

    )

     

     

               3,755

     

     

           (21,856

    )

     

     

             30,307

    Other income, net

     

               1,445

     

     

     

               2,415

     

     

               5,471

     

     

     

               6,545

    Income (loss) before income taxes

     

           (21,407

    )

     

     

               6,170

     

     

           (16,385

    )

     

     

             36,852

    Income tax benefit

     

               7,142

     

     

     

                  866

     

     

               9,558

     

     

     

                  340

    Net income (loss)

     $

        (14,265

    )

     

     $

            7,036

     

     $

          (6,827

    )

     

     $

         37,192

               
               
    Net income (loss) per share            
    Basic

     $

            (0.71

    )

     

     $

              0.36

     $

            (0.34

    )

     

     $

              1.90

    Diluted

     $

            (0.71

    )

     

     $

              0.33

     $

            (0.34

    )

     

     $

              1.77

    Weighted average common shares outstanding            
    Basic

     

             20,020

     

     

     

             19,673

     

             19,897

     

     

     

             19,549

    Diluted

     

             20,020

     

     

     

             21,105

     

             19,897

     

     

     

             20,999

     

    ENANTA PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    UNAUDITED

    (in thousands)

           
     

    June 30,

     

    September 30,

         

    2020

     

    2019

    Assets          
    Current assets         
    Cash and cash equivalents  

     $

                       99,855

     

     $

                           51,230

    Short-term marketable securities  

     

                        270,145

     

     

                            284,006

    Accounts receivable  

     

                          18,653

     

     

                              51,313

    Prepaid expenses and other current assets  

     

                          24,728

     

     

                              15,299

    Total current assets  

     

    413,381

     

     

    401,848

    Long-term marketable securities  

     

                          65,404

     

     

                              65,013

    Property and equipment, net  

     

                            9,285

     

     

                              10,927

    Deferred tax assets  

     

                          15,289

     

     

                              11,341

    Operating lease, right-of-use assets  

     

                            7,645

     

     

                                       —

    Restricted cash  

     

                                608

     

     

                                    608

    Other long-term assets  

     

                                  92

     

     

                                      92

    Total assets  

    $

                      511,704

     

    $

                          489,829

    Liabilities and Stockholders' Equity        
    Current liabilities        
    Accounts payable  

     $

                         6,074

     

     $

                             6,689

    Accrued expenses and other current liabilities  

     

                          13,576

     

     

                              15,920

    Operating lease liabilities  

     

                            4,264

     

     

                                       —

    Total current liabilities  

     

                          23,914

     

     

                              22,609

    Operating lease liabilities, net of current portion  

     

                            4,547

     

     

                                       —

    Series 1 nonconvertible preferred stock  

     

                            1,628

     

     

                                1,628

    Other long-term liabilities  

     

                            1,058

     

     

                                3,100

    Total liabilities  

     

                          31,147

     

     

                              27,337

    Total stockholders' equity  

     

                        480,557

     

     

                            462,492

    Total liabilities and stockholders' equity  

    $

                      511,704

     

    $

                          489,829

           

     

    View Full Article Hide Full Article
  28. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2020 on August 10, 2020 at 1:00 p.m. ET.

    A live webcast will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference 2020 on August 10, 2020 at 1:00 p.m. ET.

    A live webcast will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  29. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal third quarter ended June 30, 2020 after the U.S. markets close on August 4, 2020. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information
    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it plans to report its financial results for its fiscal third quarter ended June 30, 2020 after the U.S. markets close on August 4, 2020. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta's business, including its research and development pipeline.

    Conference Call and Webcast Information

    To participate in the live conference call, please dial 855-840-0595 in the U.S. or 518-444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on August 4, 2020, through 11:59 p.m. ET on August 6, 2020 by dialing 855-859-2056 from the U.S. or 404-537-3406 for international callers. The passcode for both the live call and the replay is 7561838. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
    • Initiated Phase 1b Study Evaluating EDP-514 in Viremic HBV Patients; Preliminary Data Anticipated in 1H 2021
    • Resumed Phase 1b Study Assessing Safety and Antiviral Activity of EDP-514 in NUC-Suppressed HBV Patients; Topline Results Anticipated in 2Q 2021

    Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced advancements in its hepatitis B virus (HBV) program evaluating EDP-514 across different patient populations. Enanta initiated, as planned, a Phase 1b clinical trial in viremic HBV patients, and resumed its ongoing Phase 1b study in HBV patients treated with a nucleos(t)ide reverse transcriptase inhibitor (NUC-suppressed…

    • Initiated Phase 1b Study Evaluating EDP-514 in Viremic HBV Patients; Preliminary Data Anticipated in 1H 2021
    • Resumed Phase 1b Study Assessing Safety and Antiviral Activity of EDP-514 in NUC-Suppressed HBV Patients; Topline Results Anticipated in 2Q 2021

    Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced advancements in its hepatitis B virus (HBV) program evaluating EDP-514 across different patient populations. Enanta initiated, as planned, a Phase 1b clinical trial in viremic HBV patients, and resumed its ongoing Phase 1b study in HBV patients treated with a nucleos(t)ide reverse transcriptase inhibitor (NUC-suppressed patients), which was previously paused due to the COVID-19 pandemic. EDP-514 is a novel class II HBV core inhibitor that has Fast Track Designation from the FDA.

    "HBV is a potentially life-threatening liver infection, affecting over 250 million people worldwide for which there is no functional cure. We are pleased to continue to advance our HBV program with two clinical studies evaluating EDP-514 in chronic HBV patients – one in viremic patients not currently on therapy and the second in patients with HBV infection that is NUC-suppressed," said Jay R. Luly, President and Chief Executive Officer of Enanta Pharmaceuticals. "EDP-514, a novel core inhibitor of HBV replication, leverages our strength in compound optimization and targeted rational design, enabling potent anti-HBV activity at multiple steps in the HBV lifecycle. We are excited to further investigate EDP-514 in viremic HBV patients, and look forward to reporting preliminary safety and virologic data in the first half of 2021, while also completing our study in NUC-suppressed patients with topline data expected in the second quarter of 2021. As we look toward these catalysts, we are continuing to monitor any impact of the COVID-19 pandemic on our clinical progress."

    The randomized, double-blind, placebo-controlled Phase 1b study in viremic chronic HBV subjects not currently on therapy is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of orally administered EDP-514 over a 28-day period. The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of EDP-514 or placebo.

    The randomized, double-blind, placebo-controlled Phase 1b study in NUC-suppressed subjects with chronic HBV infection is Part 2 of a Phase 1a/1b study. Part 2 of the study is designed to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of orally administered EDP-514 over a 28-day period. The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of EDP-514 or placebo.

    In Part 1 of the Phase 1a/1b study, EDP-514 was studied in healthy subjects who received single or multiple doses for up to 14 days. EDP-514 was well tolerated with a favorable safety profile. Treatment-emergent adverse events were infrequent and mild in intensity. No patients discontinued EDP-514 due to an adverse event. Additionally, the pharmacokinetic profile was supportive of once-daily dosing. Enanta plans on presenting additional data from Part 1 of the Phase 1a/1b study in healthy volunteers in a poster presentation at the European Association for the Study of the Liver's (EASL) Digital International Liver Congress, August 27-29, 2020.

    About EDP-514

    EDP-514, a novel class II hepatitis B virus (HBV) core inhibitor, is Enanta's lead core inhibitor candidate. Core inhibitors, also known as capsid assembly modulators or core protein allosteric modulators, are a novel class of HBV replication inhibitors that have been shown to act at multiple steps in the HBV lifecycle. Preclinical data demonstrate that EDP-514 is a potent inhibitor of HBV replication and prevents the denovo formation of new cccDNA in primary human hepatocytes when given early during HBV infection. In vitro data also show that EDP-514 is pan-genotypic, and that combinations of EDP-514 with a nucleos(t)ide reverse-transcriptase inhibitor (NRTI), the current anti-viral therapy for HBV, or with a class I core inhibitor, result in additive to synergistic antiviral effects. ln vivo models of EDP-514 demonstrate excellent efficacy with >4-log viral load reduction in HBV-infected PXB mice.

    About Hepatitis B Virus

    Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease. The virus is most commonly transmitted from mother to child during birth and delivery, as well as through contact with blood or other body fluids. It is estimated that over 250 million people have chronic HBV infection. According to the World Health Organization, there are approximately 887,000 deaths from HBV infection per year mostly from cirrhosis and hepatocellular carcinoma or primary liver cancer. As of 2016, of the people living with HBV infection, only 27 million were aware of their infection, and only 4.5 million of those received treatment.1

    Current approaches to treatment include interferon therapy and/or inhibitors of HBV reverse transcriptase. Treatment with interferon offers poor cure rates and is accompanied by serious side effects. Reverse transcriptase inhibitors can be very effective at suppressing the virus but rarely result in full eradication of the virus from the liver.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH), hepatitis B virus (HBV), human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    Forward Looking Statements Disclaimer

    This press release contains forward-looking statements, including statements with respect to the prospects for further development of EDP-514 for hepatitis B virus (HBV). Statements that are not historical facts, are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta's research and development pipeline, such as HBV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HBV; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended March 31, 2020 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    ___________________________

    1https://www.who.int/news-room/fact-sheets/detail/hepatitis-b

    View Full Article Hide Full Article
  30. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of Mark G. Foletta to its Board of Directors. Mr. Foletta will also serve as the Chair of the Audit Committee and will be a member of the Nominating and Corporate Governance Committee. The appointment of Mr. Foletta increases the number of Enanta Directors to seven.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200629005071/en/

    Enanta Pharmaceuticals Announces the Appointment of Mark G. Foletta to its Board of Directors (Photo: Business Wire)

    Enanta Pharmaceuticals Announces the Appointment of Mark G. Foletta to its Board of Directors (Photo: Business Wire)

    "We are pleased to welcome Mark to our Board…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the appointment of Mark G. Foletta to its Board of Directors. Mr. Foletta will also serve as the Chair of the Audit Committee and will be a member of the Nominating and Corporate Governance Committee. The appointment of Mr. Foletta increases the number of Enanta Directors to seven.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200629005071/en/

    Enanta Pharmaceuticals Announces the Appointment of Mark G. Foletta to its Board of Directors (Photo: Business Wire)

    Enanta Pharmaceuticals Announces the Appointment of Mark G. Foletta to its Board of Directors (Photo: Business Wire)

    "We are pleased to welcome Mark to our Board during an important time in Enanta's growth," commented Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "Mark's extensive financial, operational and governance leadership will be invaluable as we continue to develop our broad pipeline of small molecule drugs for viral infections and liver diseases."

    "Enanta is well-positioned for enduring success in advancing its virology and liver disease treatments," said Mr. Foletta. "I look forward to collaborating with the leadership team and members of the Board to further Enanta's mission and bring these critical therapies to patients in need."

    Mr. Foletta brings to Enanta more than 25 years of experience in financial, operational and governance leadership roles in the pharmaceutical and biotechnology industry. Most recently, he was Executive Vice President and Chief Financial Officer of Tocagen, a clinical-stage biopharmaceutical company focused on advancing a cancer-selective gene therapy platform, prior to its merger with Forte Biosciences. Prior to Tocagen, Mr. Foletta was Chief Financial Officer of Biocept, Inc. and served as Senior Vice President, Finance and Chief Financial Officer of Amylin Pharmaceuticals, Inc., where he helped drive the evolution of the company from a research and development organization to a fully integrated biopharmaceutical company. Mr. Foletta has held other management positions including Senior Vice President, Chief Financial Officer and Corporate Secretary of Intermark, Inc. and Triton Group Ltd. Earlier in his career he worked at Ernst & Young, LLP.

    Mr. Foletta currently serves as the Lead Independent Director of DexCom, Inc. and is Chairman of the Audit Committee of AMN Healthcare Services, Inc. He has previously served on the Boards of Directors and as Audit Committee Chair of Regulus Therapeutics, Inc., Ambit Biosciences, Inc. and Anadys Pharmaceuticals, Inc. Mr. Foletta received a B.A. in Business Economics from the University of California, Santa Barbara and is a member of the Corporate Directors Forum.

    About Enanta

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH), hepatitis B virus (HBV), human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  31. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will present at the Raymond James Human Health Innovation Conference on June 18, 2020 at 10:20 a.m. ET.

    A live webcast will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.

    About Enanta

    Enanta Pharmaceuticals is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will present at the Raymond James Human Health Innovation Conference on June 18, 2020 at 10:20 a.m. ET.

    A live webcast will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.

    About Enanta

    Enanta Pharmaceuticals is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts are currently focused on the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH), hepatitis B virus (HBV), human metapneumovirus (hMPV) and SARS-CoV-2 (COVID-19).

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection, under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
  32. Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on May 19, 2020 at 9:45 a.m. ET.

    A live webcast of the fireside chat will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.

    About Enanta

    Enanta Pharmaceuticals is using its robust, chemistry-driven…

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, will participate in a fireside chat at the 2020 RBC Capital Markets Global Healthcare Virtual Conference on May 19, 2020 at 9:45 a.m. ET.

    A live webcast of the fireside chat will be accessible by visiting the "Events and Presentations" section on the "Investors" page of Enanta's website at www.enanta.com. A replay of the webcast will be available following the presentation and will be archived for approximately 30 days.

    About Enanta

    Enanta Pharmaceuticals is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts are currently focused on the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH), hepatitis B virus (HBV), human metapneumovirus (hMPV) and SARS-CoV-2.

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta, is sold by AbbVie in numerous countries as part of its leading treatment for chronic HCV infection. This leading HCV regimen is sold under the tradenames MAVYRET™ (U.S.) and MAVIRET™ (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    View Full Article Hide Full Article
    • On Track to Initiate Phase 1b Study of EDP-514 in Viremic Hepatitis B Patients in 2Q 2020 and Phase 1 Study of EDP-297 in 3Q 2020
    • Royalty Revenue for the Quarter was $27.6 Million
    • Cash and Marketable Securities Totaled $435.4 Million at March 31, 2020

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal second quarter ended March 31, 2020.

    "Enanta is fortunate to have advanced several of its programs in the recent quarter and it continues to have a strong balance sheet and ongoing royalty funding to support its business plans going forward," said Jay R. Luly, President and…

    • On Track to Initiate Phase 1b Study of EDP-514 in Viremic Hepatitis B Patients in 2Q 2020 and Phase 1 Study of EDP-297 in 3Q 2020
    • Royalty Revenue for the Quarter was $27.6 Million
    • Cash and Marketable Securities Totaled $435.4 Million at March 31, 2020

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal second quarter ended March 31, 2020.

    "Enanta is fortunate to have advanced several of its programs in the recent quarter and it continues to have a strong balance sheet and ongoing royalty funding to support its business plans going forward," said Jay R. Luly, President and Chief Executive Officer of Enanta Pharmaceuticals. "The current pandemic has underscored our commitment as a company to bring forth novel anti-viral therapies for respiratory viruses and liver infections, and we remain highly dedicated to the clinical advancement of our innovative small molecule pipeline. We are on schedule to initiate our Phase 1b study of EDP-514 in viremic hepatitis B patients this quarter, and we also expect to initiate a first-in-human study of our follow-on Farnesoid X receptor agonist, EDP-297, next quarter. Additionally, we have plans for two additional studies of EDP-938 for respiratory syncytial virus to start by year-end, one in pediatric patients and one in adult transplant patients. With these catalysts in mind, we continue to monitor any impact of COVID-19 on all of our clinical studies."

    Fiscal Second Quarter Ended March 31, 2020 Financial Results

    Total revenue for the three months ended March 31, 2020 was $27.6 million and consisted of royalty revenue derived primarily from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET® (glecaprevir/pibrentasvir). For the three months ended March 31, 2019, total revenue was $39.6 million, which consisted of royalty revenue earned on AbbVie's global net sales of its HCV regimens. AbbVie has reported that the decrease in its first quarter 2020 HCV sales was due to lower patient volumes in select international markets where patients are treated in hospitals affected by COVID-19, as well as increased competition affecting pricing and market share within the U.S. Managed Medicaid segment.

    Research and development expenses totaled $32.6 million for the three months ended March 31, 2020, compared to $34.2 million for the three months ended March 31, 2019. The decrease in research and development expenses was primarily due to a decrease in clinical trial expense due to timing of Phase 2 studies in non-alcoholic steatohepatitis (NASH)/primary biliary cholangitis (PBC) conducted in the prior year.

    General and administrative expenses totaled $6.9 million for the three months ended March 31, 2020, compared to $6.8 million for the three months ended March 31, 2019.

    Enanta recorded an income tax benefit of $3.9 million for the three months ended March 31, 2020 compared to an income tax benefit of $3.2 million for the same period of 2019. The income tax benefit for the three months ended March 31, 2020 was due to a pre-tax loss and increased research and development tax credits. In the prior year, Enanta recorded an income tax benefit despite reporting pre-tax income due to tax deductions from employee stock award-related activity during the quarter.

    Net loss for the three months ended March 31, 2020 was $6.0 million, or a loss of $0.30 per diluted common share, compared to net income of $4.1 million, or $0.20 per diluted common share, for the corresponding period in 2019.

    Enanta's cash, cash equivalents and short-term and long-term marketable securities totaled $435.4 million at March 31, 2020. This compares to a total of $400.3 million at September 30, 2019. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its continuing royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.

    Pipeline Programs and Near-term Milestones

    • Respiratory Syncytial Virus (RSV): N-Protein Inhibitor EDP-938, Human Metapneumovirus (hMPV) and SARS-CoV-2
      • Continue with plans to broaden the RSVP study into the Southern Hemisphere, and to expand to trials sites in Europe and North America in the fall and winter RSV season, with the goal of having data in the third quarter of 2021
      • Plan to initiate Phase 2 dose ranging study in pediatric patients with RSV in 4Q 2020
      • Plan to initiate Phase 2 study in adult transplant patients with RSV in 4Q 2020
      • Perform optimization of Enanta's current nanomolar hMPV inhibitor leads
      • Advance efforts for discovery of direct-acting antiviral compounds for SARS-CoV-2
    • Hepatitis B (HBV): Core Inhibitor EDP-514
      • Initiate Phase 1b study in viremic HBV patients in 2Q 2020
      • Resume recruitment in Phase 1b study in nuc-suppressed HBV patients, currently paused
    • Non-Alcoholic Steatohepatitis (NASH): Farnesoid X Receptor (FXR) Agonists EDP-305 and EDP-297
      • Resume recruitment and dosing in ARGON-2 Phase 2b study of EDP-305 in NASH, currently paused
      • Plan to initiate Phase 1 study of EDP-297 (follow-on FXR for NASH) in 3Q 2020
      • Advance efforts for discovery of non-FXR compounds for NASH
    • Hepatitis C (HCV) Collaboration with AbbVie
      • AbbVie announced that the European Commission approved a change to the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic HCV patients with genotype (GT) 3 infection. The decision makes MAVIRET the only pan-genotypic (GTs 1-6) 8-week treatment option for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis.

    Upcoming Events and Presentations

    • May 19, 2020 – RBC Capital Markets Global Healthcare Conference, Virtual
    • June 18, 2020 – Raymond James Healthcare Conference, Virtual
    • Enanta plans to issue its fiscal third quarter financial results press release, and hold a conference call regarding those results, on August 4, 2020.

    Conference Call and Webcast Information

    Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on May 6, 2020, through 11:59 p.m. ET on May 8, 2020 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for international callers. The passcode for both the live call and the replay is 4261269. A live audio webcast of the call and replay can be accessed by visiting the "Events and Presentation" section on the "Investors" page of Enanta's website at www.enanta.com.

    About Enanta Pharmaceuticals, Inc.

    Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta's research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and emerging coronaviruses, including SARS-CoV-2.

    Enanta's research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta and now marketed by AbbVie as part of its leading treatment for chronic HCV infection, is sold under the brand names MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

    FORWARD LOOKING STATEMENTS

    This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta's clinical programs in RSV, NASH and HBV, as well as discovery programs in hMPV and SARS-CoV-2, and prospects for future royalty revenue from sales of AbbVie's MAVYRET®/MAVIRET® HCV regimen. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta's revenues in the short-term are dependent upon the level of AbbVie's sales of its MAVYRET®/MAVIRET® HCV regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, NASH, and HBV; competitive pricing, market acceptance and reimbursement rate actions affecting MAVYRET®/MAVIRET® compared to competitive HCV products on the market; the discovery and development risks of Enanta's programs in RSV, NASH, HBV, hMPV, SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; Enanta's lack of clinical development experience; Enanta's need to attract and retain senior management and key research and development personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Form 10-Q for the quarter ended December 31, 2019, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    UNAUDITED
    (in thousands, except per share amounts)
     
     
    Three Months Ended Six Months Ended
    March 31, March 31,

    2020

    2019

    2020

    2019

     
    Revenue

    $ 27,619

    $ 39,631

    $ 80,189

    $ 109,517

    Operating expenses
    Research and development

    32,610

    34,155

    65,388

    69,033

    General and administrative

    6,884

    6,780

    13,805

    13,932

    Total operating expenses

    39,494

    40,935

    79,193

    82,965

    Income (loss) from operations

    (11,875)

    (1,304)

    996

    26,552

    Other income, net

    1,950

    2,245

    4,026

    4,130

    Income (loss) before income taxes

    (9,925)

    941

    5,022

    30,682

    Income tax (expense) benefit

    3,920

    3,204

    2,416

    (526)

    Net income (loss)

    $ (6,005)

    $ 4,145

    $ 7,438

    $ 30,156

     
     
    Net income (loss) per share
    Basic

    $ (0.30)

    $ 0.21

    $ 0.37

    $ 1.55

    Diluted

    $ (0.30)

    $ 0.20

    $ 0.36

    $ 1.44

    Weighted average common shares outstanding
    Basic

    19,922

    19,549

    19,836

    19,487

    Diluted

    19,922

    21,084

    20,692

    20,946

    ENANTA PHARMACEUTICALS, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    UNAUDITED
    (in thousands)
                 
            March 31,   September 30,
           

    2020

     

    2019