ENTA Enanta Pharmaceuticals Inc.

91.89
+5  (+6%)
Previous Close 86.89
Open 86.04
52 Week Low 40.32
52 Week High 102
Market Cap $1,857,542,567
Shares 20,214,850
Float 15,917,284
Enterprise Value $1,506,315,316
Volume 356,724
Av. Daily Volume 178,993
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Upcoming Catalysts

Drug Stage Catalyst Date
EDP-938 (RSVP)
Respiratory Syncytial Virus (community-acquired)
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
EDP-938 (RSVTx)
Respiratory Syncytial Virus Infections
Phase 2b
Phase 2b
Phase 2b trial has been initiated.
EDP-305 INTREPID
Primary biliary cholangitis (PBC)
Phase 2
Phase 2
Phase 2 top-line data did not meet primary endpoint - May 6, 2020.
EDP-721
Hepatitis B
Phase 1
Phase 1
Development discontinued, noted November 18, 2021.
EDP-297
Non-alcoholic steatohepatitis (NASH)
Phase 1
Phase 1
Phase 1 data showed that is not substantially differentiated from EDP-305, noted October 4, 2021. The company announced a strategic decision to discontinue internal development, noted November 22, 2021.
EDP-305 ARGON-2
Non-alcoholic steatohepatitis (NASH)
Phase 2b
Phase 2b
Phase 2b interim analysis showed 1.0 mg as the optimal dose. The monontherapy has been discontinued and priority is placed on the combinations, noted October 4, 2021.
EDP-514
Hepatitis B - NUC-Suppressed
Phase 1b
Phase 1b
Phase 1b top-line data released May 6, 2021 - safe and well-tolerated.
EDP-514
Hepatitis B virus (HBV) - viremic chronic
Phase 1b
Phase 1b
Phase 1b demonstrated that dosing was safe and well-tolerated through 28 days of treatment, and resulted in mean HBV DNA reductions of 2.9, 3.3, and 3.5 logs at 28 days for the 200 mg, 400 mg, and 800 mg cohorts, respectively, compared to 0.2 log in placebo, noted November 12, 2021.
EDP-235
COVID-19
Phase 1
Phase 1
Phase 1 trial to be initiated early-2022.
GLECAPREVIR / PIBRENTASVIR (G/P)
Hepatitis C virus (HCV)
Approved
Approved
Approval announced August 3, 2017.
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.

Latest News

    • Presented First Preclinical Data for EDP-235, an Oral Protease Inhibitor Specifically Designed for the Treatment of COVID-19; First-in-Human Study Planned for Early 2022
    • Reported Positive Clinical Data from Two Phase 1b Studies of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic and NUC-Suppressed Chronic HBV Patients; Terminated Clinical Development of EDP-721, an Oral HBV RNA Destabilizer
    • Announced Decision to Pursue Combination Approaches with Farnesoid X Receptor (FXR) Agonists for Non-Alcoholic Steatohepatitis (NASH) Through an Out-Licensing Strategy
    • Royalty Revenue for the Quarter was $23.6 Million

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule…

    • Presented First Preclinical Data for EDP-235, an Oral Protease Inhibitor Specifically Designed for the Treatment of COVID-19; First-in-Human Study Planned for Early 2022
    • Reported Positive Clinical Data from Two Phase 1b Studies of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic and NUC-Suppressed Chronic HBV Patients; Terminated Clinical Development of EDP-721, an Oral HBV RNA Destabilizer
    • Announced Decision to Pursue Combination Approaches with Farnesoid X Receptor (FXR) Agonists for Non-Alcoholic Steatohepatitis (NASH) Through an Out-Licensing Strategy
    • Royalty Revenue for the Quarter was $23.6 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 fourth quarter and year ended September 30, 2021.

    "We ended fiscal 2021 achieving multiple milestones including presenting positive Phase 1b data of EDP-514 in two major HBV patient populations," stated Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "We were also excited to present the first preclinical data for EDP-235, our oral protease inhibitor specifically designed to target SARS-CoV-2, and we are making meaningful progress with our Phase 2b RSVP study in RSV. Looking ahead, we expect to make significant advancements across our pipeline and are on schedule to select a new clinical development candidate from our RSV L-inhibitor program by year-end and to report initial data from RSVP in the first half of 2022."

    Fiscal Fourth Quarter and Year Ended September 30, 2021 Financial Results

    Total revenue of $23.6 million for the three months ended September 30, 2021 consisted of royalty revenue derived almost entirely from worldwide net sales of AbbVie's hepatitis C virus (HCV) regimen MAVYRET®/MAVIRET®, which was unchanged from the royalty revenue of $23.6 million for the three months ended September 30, 2020. For the twelve months ended September 30, 2021, total revenue was $97.1 million compared to $122.5 million for the same period in 2020. Royalty revenue for these periods reflect that treated patient volumes remain suppressed compared to pre-COVID levels, as reported by AbbVie.

    Research and development expenses were $48.9 million for the three months ended September 30, 2021, compared to $36.7 million for the three months ended September 30, 2020. For the twelve months ended September 30, 2021, research and development expenses were $174.1 million compared to $136.8 million in 2020. The increases in both periods were due to the timing of clinical trials in the company's virology programs.

    General and administrative expenses totaled $8.4 million for the three months ended September 30, 2021, compared to $6.7 million for the three months ended September 30, 2020. For the twelve months ended September 30, 2021, general and administrative expenses were $32.5 million compared to $27.4 million in 2020. The increase was due to additional headcount and related compensation expense.

    Enanta recorded an income tax benefit of $8.8 million for the three months ended September 30, 2021 compared to an income tax expense of $10.7 million for the same period in 2020. For the twelve months ended September 30, 2021, Enanta recorded an income tax benefit of $28.6 million, compared to income tax expense of $1.1 million for the twelve months ended September 30, 2020. 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. The income tax benefit in the current period was due to the provision of the CARES Act of 2020, which enables the company to carry back its current year tax loss to offset taxable income in prior years. This provision will not apply to periods ending after September 30, 2021.

    Net loss for the three months ended September 30, 2021 was $24.6 million, or a loss of $1.22 per diluted common share, compared to a net loss of $29.3 million, or a loss of $1.46 per diluted common share, for the corresponding period in 2020. For the twelve months ended September 30, 2021, net loss was $79.0 million, or a loss of $3.92 per diluted common share, compared to a net loss of $36.2 million, or loss of $1.81 per diluted common share for corresponding period in 2020.

    Enanta's cash, cash equivalents and marketable securities totaled $352.4 million at September 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.

    Financial Guidance for Fiscal Year 2022

    • Research and Development Expense: $150 million to $170 million
    • General and Administrative Expense: $35 million to $41 million

    Pipeline Programs – Recent Events and Near-Term Milestones

    Virology

    • Respiratory Syncytial Virus (RSV): N-Protein Inhibitor EDP-938
      • Evaluating EDP-938, an N-protein inhibitor, in a broad clinical development program, consisting of three ongoing Phase 2 trials: RSVP, RSVTx and RSVPEDs.
      • Continued to establish additional trial sites worldwide for RSVP, which is designed to study the effect of EDP-938 on community-acquired RSV infection in an adult population. While RSV, like influenza, was significantly suppressed while there were mitigation measures in place to control COVID-19, more recently there has been evidence of increased RSV activity in various regions of the world, including parts of the United States and Europe. Enanta expects that enrollment in the RSVP study will be complete during the Northern Hemisphere winter season, if there is no further significant increase in COVID-19 or mitigation measures in those regions. Assuming this enrollment occurs, the company expects data in the first half of 2022.
      • For RSVTx and RSVPEDs, which were initiated more recently, enrollment is expected to require more than one global RSV season, subject to the uncertainties of the continuing pandemic.
    • COVID-19 (SARS-CoV-2): Protease Inhibitor EDP-235
      • Presented preclinical data during the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)–World Health Organization (WHO) Virtual Conference 2021 demonstrating that oral EDP-235 selectively blocked replication of SARS-CoV-2 in multiple cellular models with nanomolar potency. Further, antiviral activity was maintained against multiple SARS-CoV-2 variants. Good distribution to lung cells was observed with optimized pharmacokinetic properties supporting once-daily, oral dosing without ritonavir boosting. Enanta plans to move EDP-235 into the clinic in early 2022.
    • HBV: Core Inhibitor EDP-514 and HBV RNA Destabilizer EDP-721
      • Announced positive final data from both Phase 1b studies of EDP-514 in viremic and NUC-suppressed chronic HBV patients. These data demonstrated that the 200 mg, 400 mg, and 800 mg doses were safe and well-tolerated through 28 days of treatment and displayed pharmacokinetics supportive of once-daily dosing. In viremic patients, treatment with EDP-514 resulted in mean HBV DNA reductions of 2.9, 3.3, and 3.5 logs at 28 days for the 200 mg, 400 mg, and 800 mg cohorts, respectively, compared to a 0.2 log reduction in the placebo group.
      • Terminated development of EDP-721, an oral HBV RNA destabilizer due to adverse safety signals in a Phase 1 healthy volunteer study.
    • Respiratory Virology Discovery Initiatives: 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
        • On schedule to select a clinical candidate with potent nanomolar activity against both RSV-A and RSV-B by year-end.
      • Human Metapneumovirus (hMPV)
        • Continuing lead optimization on potent nanomolar hMPV inhibitors.

    Non-Alcoholic Steatohepatitis (NASH)

    • Announced a strategic decision to discontinue internal development of FXR agonists EDP-305 and EDP-297, to prioritize combination approaches for NASH through out-licensing.

    Corporate

    • Announced the election of Yujiro S. Hata to Enanta's Board of Directors.

    Upcoming Events and Presentations

    • Evercore HealthCONx, November 30 – December 2, 2021
    • Piper Sandler 33rd Annual Healthcare Conference, November 30 – December 2, 2021
    • 40th Annual JP Morgan Healthcare Conference, January 10 – 13, 2022
    • Enanta plans to issue its fiscal 2022 first quarter results press release, and hold a conference call regarding those results, on February 8, 2022.

    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 844-467-7101 in the U.S. or 270-215-9353 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on November 22, 2021, through 11:59 p.m. ET on November 29, 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 1973737. 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 currently in development for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) 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 part of AbbVie's leading treatment for chronic HCV infection that it sells in numerous countries 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, 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, HBV, SARS-CoV-2 and hMPV; 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, HBV, SARS-CoV-2 and hMPV; 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 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.

    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,

    2021

     

    2020

     

    2021

     

    2020

     
    Revenue

    $

    23,575

     

    $

    23,631

     

    $

    97,074

     

    $

    122,473

     

    Operating expenses
    Research and development

     

    48,946

     

     

    36,686

     

     

    174,111

     

     

    136,756

     

    General and administrative

     

    8,356

     

     

    6,728

     

     

    32,536

     

     

    27,356

     

    Total operating expenses

     

    57,302

     

     

    43,414

     

     

    206,647

     

     

    164,112

     

    Loss from operations

     

    (33,727

    )

     

    (19,783

    )

     

    (109,573

    )

     

    (41,639

    )

    Other income, net

     

    333

     

     

    1,149

     

     

    1,994

     

     

    6,620

     

    Loss before income taxes

     

    (33,394

    )

     

    (18,634

    )

     

    (107,579

    )

     

    (35,019

    )

    Income tax (expense) benefit

     

    8,795

     

     

    (10,707

    )

     

    28,583

     

     

    (1,149

    )

    Net loss

    $

    (24,599

    )

    $

    (29,341

    )

    $

    (78,996

    )

    $

    (36,168

    )

    Net loss per share
    Basic

    $

    (1.22

    )

    $

    (1.46

    )

    $

    (3.92

    )

    $

    (1.81

    )

    Diluted

    $

    (1.22

    )

    $

    (1.46

    )

    $

    (3.92

    )

    $

    (1.81

    )

    Weighted average common shares outstanding
    Basic

     

    20,221

     

     

    20,074

     

     

    20,171

     

     

    19,940

     

    Diluted

     

    20,221

     

     

    20,074

     

     

    20,171

     

     

    19,940

     

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

    September 30,

     

    September 30,

    2021

     

    2020

    Assets
    Current assets
    Cash and cash equivalents

    $

    57,206

    $

    87,131

    Short-term marketable securities

     

    186,796

     

    299,518

    Accounts receivable

     

    23,576

     

    23,492

    Prepaid expenses and other current assets

     

    14,188

     

    13,655

    Income tax receivable

     

    37,255

     

    13,041

    Total current assets

     

    319,021

     

    436,837

    Long-term marketable securities

     

    108,416

     

    32,634

    Property and equipment, net

     

    5,943

     

    8,596

    Deferred tax assets

     

     

    345

    Operating lease, right-of-use assets

     

    4,711

     

    7,020

    Restricted cash

     

    608

     

    608

    Other long-term assets

     

    92

     

    92

    Total assets

    $

    438,791

    $

    486,132

    Liabilities and Stockholders' Equity
    Current liabilities
    Accounts payable

    $

    9,540

    $

    5,737

    Accrued expenses and other current liabilities

     

    22,429

     

    14,159

    Operating lease liabilities

     

    4,203

     

    4,261

    Total current liabilities

     

    36,172

     

    24,157

    Operating lease liabilities, net of current portion

     

    1,126

     

    3,838

    Series 1 nonconvertible preferred stock

     

    1,506

     

    1,479

    Other long-term liabilities

     

    558

     

    1,078

    Total liabilities

     

    39,362

     

    30,552

    Total stockholders' equity

     

    399,429

     

    455,580

    Total liabilities and stockholders' equity

    $

    438,791

    $

    486,132

     

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  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 in December:

    • Evercore ISI 4th Annual HealthCONx Conference, December 1, 2021 with a fireside chat at 10:30 a.m. ET.
    • Piper Sandler 33rd Annual Healthcare Conference, December 2, 2021. Company pre-recorded fireside chat will become available to registered conference attendees on Monday, November 29, 2021 at 10:00 a.m. ET.

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

    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 in December:

    • Evercore ISI 4th Annual HealthCONx Conference, December 1, 2021 with a fireside chat at 10:30 a.m. ET.
    • Piper Sandler 33rd Annual Healthcare Conference, December 2, 2021. Company pre-recorded fireside chat will become available to registered conference attendees on Monday, November 29, 2021 at 10:00 a.m. ET.

    A webcast of the 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 14 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), hepatitis B virus (HBV) 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. Discontinuing Clinical Development of EDP-721, an Oral HBV RNA Destabilizer

    Continuing to Focus on Development of EDP-514 in Combination Regimens as a Functional Cure for HBV

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced it is discontinuing development of EDP-721, an oral HBV RNA destabilizer, based on emerging safety observations in the single ascending dose part of a Phase 1 study in healthy volunteers.

    "Despite the clean preclinical safety profile demonstrated in comprehensive toxicology studies, safety signals were seen in healthy subjects after administration of EDP-721. Patient safety is our top priority…

    Discontinuing Clinical Development of EDP-721, an Oral HBV RNA Destabilizer

    Continuing to Focus on Development of EDP-514 in Combination Regimens as a Functional Cure for HBV

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced it is discontinuing development of EDP-721, an oral HBV RNA destabilizer, based on emerging safety observations in the single ascending dose part of a Phase 1 study in healthy volunteers.

    "Despite the clean preclinical safety profile demonstrated in comprehensive toxicology studies, safety signals were seen in healthy subjects after administration of EDP-721. Patient safety is our top priority, and we have therefore decided to discontinue further development of this compound," said Jay R. Luly Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "We are committed to developing a functional cure for chronic hepatitis B patients, and remain confident in EDP-514, our HBV core inhibitor, which has demonstrated safe and robust antiviral activity in Phase 1b studies of viremic and NUC-suppressed patients with chronic HBV infection. We believe core inhibitors will be an important component of a successful combination regimen, and we will look to advance our HBV program with additional mechanisms from internal discovery efforts, external opportunities, or both. Importantly, we are grateful to our Principal Investigator and his study team, and the participants in the Phase 1 study for their commitment to HBV research, and to our team for all their efforts in supporting the development and clinical evaluation of EDP-721."

    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 currently in development for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) 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 part of AbbVie's leading treatment for chronic HCV infection that it sells in numerous countries 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 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/

     

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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 that it plans to report its financial results for its fiscal fourth quarter and year-ended September 30, 2021 after the U.S. market closes on November 22, 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 844-467-7101 in the U.S. or 270-215-9353 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, 2021 after the U.S. market closes on November 22, 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 844-467-7101 in the U.S. or 270-215-9353 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on November 22, 2021, through 11:59 p.m. ET on November 29, 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 1973737. 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 currently in development for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) 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.

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  4. EDP-514 is Safe and Well-Tolerated up to 800 mg

    Robust Antiviral Activity Demonstrated in Chronic Hepatitis B Virus Patients at All Doses

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced final Phase 1b data for EDP-514, a novel pangenotypic class II hepatitis B virus (HBV) core inhibitor, in conjunction with two posters presented at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD).

    "We are excited to present final data for EDP-514 from our Phase 1b studies in viremic and NUC-suppressed chronic HBV patients, giving us continued confidence in EDP-514 as a potential…

    EDP-514 is Safe and Well-Tolerated up to 800 mg

    Robust Antiviral Activity Demonstrated in Chronic Hepatitis B Virus Patients at All Doses

    Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced final Phase 1b data for EDP-514, a novel pangenotypic class II hepatitis B virus (HBV) core inhibitor, in conjunction with two posters presented at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD).

    "We are excited to present final data for EDP-514 from our Phase 1b studies in viremic and NUC-suppressed chronic HBV patients, giving us continued confidence in EDP-514 as a potential treatment for HBV," said Jay R. Luly, PhD, President and Chief Executive Officer of Enanta Pharmaceuticals. "At 800 mg, EDP-514 continues to demonstrate that it is safe and well-tolerated up to 28 days when dosed alone or in combination with NUC, as shown in the NUC-suppressed patients. Importantly, EDP-514 has robust antiviral activity across all dose groups, as best illustrated in the viremic patients where up to a 3.5 log decline in HBV DNA was observed. These data are supportive of a once-daily oral dosing regimen that could provide a foundation for a combination therapy approach to achieve functional cures for chronic HBV patients."

    822: "EDP-514, a Novel Pangenotypic Class II Hepatitis B Virus Core Inhibitor: Results of a 28-day Phase 1b Study in NUC-Suppressed CHB Patients"

    Jordan J. Feld, MD, MPH, Toronto Centre for Liver Disease, University Health Network, Toronto, Canada

    The poster highlights data from Part 2 of a Phase 1a/1b randomized, double-blind, placebo-controlled study assessing the safety, tolerability, pharmacokinetics 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.

    Overall, EDP-514 was generally safe and well-tolerated at 200 mg, 400 mg, and 800 mg doses for 28 days. EDP-514 was rapidly absorbed and its exposure increased with increasing multiple doses. EDP-514 exhibited pharmacokinetics suitable for once daily oral dosing, with Ctrough concentrations reaching up to ~20-fold above the protein-adjusted EC50. At Day 28, mean HBV RNA changes of -0.81, -1.12, 0.10, and -0.19 logs were observed in the 200 mg, 400 mg, 800 mg and placebo groups, respectively. EDP-514 led to a maximum HBV RNA reduction of 2.3 log in HBeAg-negative and 2.8 log in HBeAg-positive subjects in EDP-514 arms compared to 1.2 log in the placebo arm. In the EDP-514 800 mg arm, five of six subjects had either non-detectable or very low levels of HBV RNA at baseline; consequently, the effect of EDP-514 on HBV RNA could not be assessed in these subjects. As expected in this NUC-suppressed patient population, there were no discernible changes in HBV DNA, HBeAg, HBcrAg, and HBsAg, and no instances of virologic failure were reported.

    823: "EDP-514, a Novel Pangenotypic Class II Hepatitis B Virus Core Inhibitor Demonstrates Significant HBV DNA and HBV RNA Reductions in a Phase 1b Study in Viremic, Chronic Hepatitis B Infected Patients"

    Man Fung Yuen, MBBS, MD, PhD, DSc, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Hong Kong.

    Data in this poster details results from a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety, pharmacokinetics and antiviral activity of three doses of EDP-514 in viremic chronic HBV patients, 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.

    Results demonstrated that EDP-514 was 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, 3.3, and 3.5 logs at 28 days for the 200 mg, 400 mg, and 800 mg cohorts, respectively, compared to 0.2 log in placebo. HBV RNA was undetectable at Day 28 in 11 patients in the three EDP-514 cohorts as compared to none in placebo. Mean HBV RNA reductions were 2.9, 2.4, and 2.0 logs for the 200 mg, 400 mg, and 800 mg cohorts, respectively, compared to 0.02 log in placebo.

    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 covalently-closed circular DNA (cccDNA) in primary human hepatocytes when given early during HBV infection. In vitro data also show that EDP-514 is pangenotypic, and that combinations of EDP-514 with a nucleoside reverse transcriptase inhibitor (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 currently in development for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) 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-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 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. Polaris Observatory Collaborators. "Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study." The Lancet. Gastroenterology & Hepatology vol. 3,6 (2018): 383-403. doi:10.1016/S2468-1253(18)30056-6

    2. Woo, Aaron Shu Jeng et al. "Alpha-interferon treatment in hepatitis B." Annals of Translational Medicine vol. 5,7 (2017): 159. doi:10.21037/atm.2017.03.69

    3. Yeo, Yee Hui et al. "Factors Associated with Rates of HBsAg Seroclearance in Adults with Chronic HBV Infection: A Systematic Review and Meta-analysis." Gastroenterology vol. 156,3 (2019): 635-646.e9. doi:10.1053/j.gastro.2018.10.027

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