Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2021 with Webcast and Conference Call Today at 4:30 p.m. ET
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today reported financial results for its fiscal second quarter ended March 31, 2021.
“This quarter was marked by meaningful progress, particularly as we further our efforts to develop an all-oral regimen for chronic HBV patients,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “We are especially pleased with the safety, tolerability, pharmacokinetic, and HBV RNA data we announced today from our Phase 1b study in NUC-suppressed patients, which reinforces our belief in EDP-514’s potential to serve as the foundation of an oral combination treatment approach to achieve a functional cure in patients with HBV. We also remain on track for other key milestones in our HBV program later this quarter, including reporting preliminary data from our Phase 1b trial of EDP-514 in viremic chronic HBV patients and initiating a Phase 1 study of EDP-721, our novel HBV RNA destabilizer. Looking to the rest of our pipeline, we are excited to soon initiate IND-enabling studies of a lead oral protease inhibitor specifically designed to target SARS-CoV-2, with a goal of beginning a Phase 1 study in early 2022. Each milestone we achieve brings us closer to our vision of being a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases.”
Fiscal Second Quarter Ended March 31, 2021 Financial Results
Total revenue for the three months ended March 31, 2021 was
Research and development expenses totaled
General and administrative expenses totaled
Enanta recorded an income tax benefit of
Net loss for the three months ended March 31, 2021 was
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled
Pipeline Programs and Near-Term Milestones
Virology
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HBV: Core Inhibitor EDP-514 and RNA Destabilizer EDP-721
- Positive preliminary data announced today from the Phase 1b study of EDP-514 in NUC-suppressed chronic HBV patients. The 200 mg and 400 mg doses were safe and well-tolerated, with pharmacokinetics supportive of once daily dosing. The 800 mg cohort is ongoing and final study results will be presented at a future scientific conference.
- Preliminary data expected from the ongoing Phase 1b study of EDP-514 in viremic chronic HBV patients in the second quarter of 2021.
- On track to initiate a Phase 1 clinical study of EDP-721 in mid-2021. EDP-721 is an oral, potent and selective HBV RNA destabilizer being developed for use in combination with other mechanisms, with the goal of achieving an all-oral functional cure.
- Presenting the discovery and preclinical characterization of EDP-721 in a poster at the International Liver CongressTM, sponsored by the European Association for the Study of the Liver (EASL), in June.
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RSV: N-Protein Inhibitor EDP-938
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Due to ongoing COVID-19 mitigation measures, RSV, like influenza, did not emerge during the usual late-fall and winter RSV season in the Northern Hemisphere in 2020-2021. Enanta continues its preparedness efforts to establish trial sites in North America, Europe, the Asia-Pacific region, and the Southern Hemisphere.
- Continuing extensive efforts to double the number of clinical sites globally for RSVP, a Phase 2b randomized, double-blind, placebo-controlled study in 70 adult outpatients with community-acquired RSV infection.
- Initiated RSVPEDs, a Phase 2 randomized, double-blind, placebo-controlled study in 90 pediatric RSV patients, in March 2021.
- Continuing to activate sites for RSVTx, a Phase 2b randomized, double-blind, placebo-controlled study in 200 adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection.
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Due to ongoing COVID-19 mitigation measures, RSV, like influenza, did not emerge during the usual late-fall and winter RSV season in the Northern Hemisphere in 2020-2021. Enanta continues its preparedness efforts to establish trial sites in North America, Europe, the Asia-Pacific region, and the Southern Hemisphere.
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Respiratory Virology Discovery Initiatives – In 2021, Enanta expects to identify two clinical development candidates among its three discovery initiatives below:
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COVID-19
- IND-enabling studies of a lead oral protease inhibitor specifically designed for SARS-CoV-2 are expected to begin later this quarter, with the goal to have a candidate in a Phase 1 study in early 2022.
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RSV L-Protein Inhibitor
- Optimization of leads with potent nanomolar activity against both RSV-A and RSV-B is ongoing, with potential for use alone or in combination with agents targeting other RSV mechanisms, such as EDP-938, to possibly broaden the addressable treatment window or patient population.
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Human Metapneumovirus (hMPV)
- Lead optimization on potent nanomolar hMPV inhibitors is currently ongoing.
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COVID-19
NASH
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Farnesoid X Receptor (FXR) Agonist EDP-305
- Continuing recruitment and dosing in ARGON-2 Phase 2b study of EDP-305, with a blinded 12-week internal interim analysis on a subset of patients to inform next steps, is expected in the third quarter of 2021, rather than in mid-year.
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EDP-297, a Highly Potent and Targeted FXR Agonist
- Continuing recruitment and dosing in a Phase 1 study of EDP-297, with data expected in mid-2021.
Upcoming Events and Presentations
- RBC Capital Markets Global Healthcare Conference (May 18-19, 2021)
- JMP Securities 2021 Life Sciences Conference (June 16-17, 2021)
- Raymond James Human Health Innovation Conference (June 21-23, 2021)
- The International Liver Congress™ 2021 sponsored by EASL (June 23-26, 2021)
- Enanta plans to issue its fiscal third quarter financial results press release, and hold a conference call regarding those results, on August 5, 2021.
Conference Call and Webcast Information
Enanta will host a conference call and webcast today at 4:30 p.m. ET. To participate in the live conference call, please dial (855) 840-0595 in the U.S. or (518) 444-4814 for international callers. A replay of the conference call will be available starting at approximately 7:30 p.m. ET on May 6, 2021, through 11:59 p.m. ET on May 10, 2021 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for international callers. The passcode for both the live call and the replay is 4283865. A live audio webcast of the call and replay can be accessed by visiting the “Events and Presentation” section on the “Investors” page of Enanta’s website at www.enanta.com.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections and liver diseases. Enanta’s research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV). Enanta is also conducting research in human metapneumovirus (hMPV) and emerging coronaviruses, including SARS-CoV-2.
Enanta’s research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie. Glecaprevir, a protease inhibitor discovered by Enanta and now marketed by AbbVie as part of its leading treatment for chronic HCV infection, is sold under the brand names MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements with respect to the prospects for advancement of Enanta’s clinical programs in RSV, NASH and HBV, as well as discovery initiatives in SARS-CoV-2, RSV and hMPV. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV, HBV, HCV, COVID-19 and NASH; the discovery and development risks of Enanta’s programs in RSV, HBV, NASH, hMPV and SARS-CoV-2; the competitive impact of development, regulatory and marketing efforts of others in those disease areas; Enanta’s lack of clinical development experience; Enanta’s need to attract and retain senior management and key research and development personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s most recent Form 10-Q for the quarter ended December 31, 2020, and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.
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Enanta Pharmaceuticals, Inc.
NASDAQ:ENTAENTA RankingsENTA Latest NewsENTA Stock Data
254.79M
13.34M
6.1%
100.26%
12.97%
Pharmaceutical Preparation Manufacturing
Manufacturing
United States of America
WATERTOWN
About ENTAenanta pharmaceuticals is a research and development-focused biotechnology company that uses its robust chemistry-driven approach and drug discovery capabilities to create small molecule drugs for viral infections and liver diseases. enanta is discovering, and in some cases developing, novel inhibitors designed for use against the hepatitis c virus (hcv). these inhibitors include members of the direct acting antiviral (daa) inhibitor classes – protease (partnered with abbvie), ns5a, and nucleotide polymerase – as well as a host-targeted antiviral (hta) inhibitor class targeted against cyclophilin. enanta’s lead protease inhibitor, paritaprevir, is part of abbvie’s recently approved hcv treatment regimen. in addition, enanta has a preclinical program in non-alcoholic steatohepatitis, or nash, which is a condition that results in liver inflammation and damage caused by a buildup of fat in the liver. enanta pharmaceuticals is a public company with offices in watertown, ma.
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