ENTA Enanta Pharmaceuticals Inc.

46.72
-1.62  -3%
Previous Close 48.34
Open 47.94
52 Week Low 38.4
52 Week High 59.63
Market Cap $938,088,170
Shares 20,078,942
Float 16,410,704
Enterprise Value $559,538,170
Volume 114,485
Av. Daily Volume 165,418
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Upcoming Catalysts

Drug Stage Catalyst Date
EDP-514
Hepatitis B virus (HBV) - viremic chronic
Phase 1b
Phase 1b
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EDP-297
Non-alcoholic steatohepatitis (NASH)
Phase 1
Phase 1
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EDP-514
Hepatitis B - NUC-Suppressed
Phase 1b
Phase 1b
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EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
EDP-938 (RSVP)
Respiratory Syncytial Virus (community-acquired)
Phase 2b
Phase 2b
Phase 2b trial ongoing. Data delayed due to RSV season not beginning in the Northern Hemisphere due to COVID-19 mitigation measures.
EDP-305 INTREPID
Primary biliary cholangitis (PBC)
Phase 2
Phase 2
Phase 2 top-line data did not meet primary endpoint - May 6, 2020.
VIEKIRA PAK - once-daily, fixed-dose formulation through Abbvie
HCV - genotype
Approved
Approved
Approved July 25, 2017.
VIEKIRA PAK
HCV - genotype 1
Approved
Approved
Approved December 19, 2014.
Glecaprevir/Pibrentasvir (G/P)
Hepatitis C virus (HCV)
Approved
Approved
Approval announced August 3, 2017.

Latest News

    • 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.

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  1. 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.

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  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 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.

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  3. 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.

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  4. 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

     

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