Enanta Pharmaceuticals, Inc.

Good afternoon and welcome to an ANTA Pharmaceuticals Fiscal Third Quarter conference call. At this time, all participants are in listen-only mode. There will be a question-and-answer session at the end of the prepared remarks. Please be advised that this call is being recorded. I will now turn the call over to Jennifer Viera, Senior Director, Investor Relations. Please go ahead.

Thank you, Operator, and thanks to everyone for joining us this afternoon. The news release with our financial results for the recent quarter was issued this afternoon and is available on our website. On the call today is Dr. Jay Luly, President and Chief Executive Officer, Paul Mellet, our Chief Financial Officer, and other members of Enanta's senior management team. Before we begin with our formal remarks, I want to remind you that we will be making forward-looking statements, which may include our plans and expectations With respect to our product candidates and financial projections, all of which involve certain assumptions and risks beyond our control that could cause our actual developments and results to differ materially from those statements. A description of these risks is in our most recent Form 10-Q and other periodic reports filed with the SEC. Enanta does not undertake any obligation to update any forward-looking statements made during this call. I'd now like to turn the call over to Dr. Jay Luly, President and CEO. Jay?

Thank you, Jennifer. Good afternoon, everyone. Thank you for joining us today. I'm pleased to report the progress we've made during the quarter across our pipeline, which is focused on our two areas of expertise, virology and liver disease, with programs in respiratory syncytial virus, hepatitis B virus, human metanemovirus, SARS-CoV-2, and non-alcoholic steatohepatitis. On this call, I will discuss clinical and preclinical updates across our pipeline, and Paul will review the financials for the quarter. Before I get into my formal remarks, I want to take a moment to welcome Mark Folletta, whose appointment we announced in June to our board of directors. We're very pleased to have Mark join our team, where he will serve as chair of the audit committee will be a member of the Nominating and Governance Committee. Mark has extensive financial, operating, and governance experience, previously serving as Chief Financial Officer for various biopharma companies, including Amelin Pharmaceuticals. Mark will be instrumental in helping us as we advance our pipeline of innovative treatments for viral infections and liver diseases. Additionally, I want to take a few moments to comment on the resiliency of our team here at Enantix. Despite the backdrop of the ongoing COVID-19 pandemic, the team has been able to stay focused and ensure that our business progresses and that our pipeline continues to mature. We have clinical studies ongoing with three different compounds. We are preparing a fourth compound to move into the clinic this quarter, and we are continuing our work to develop candidates for human metapneumovirus and SARS-CoV-2. To that end, I'll begin with our virology-focused programs, where we are leveraging our antiviral drug discovery expertise to discover and develop multiple product candidates. I'll start with EDP514, our lead core inhibitor and our HPV program that is currently being tested in both viremic HPV patients and nuke-suppressed HPV patients. We are committed to developing a treatment for HPV as it is a disease with a true unmet need. It's estimated that HPV affects more than 250 million people worldwide. In early July, we announced that we initiated our Phase 1B clinical trial in viremic HPV patients. This randomized, double-blind, placebo-controlled Phase 1B study in viremic chronic HPV subjects not currently on therapy is designed to evaluate the safety, tolerability, pharmacokinetics, and any viral activity of orally administered EDP514 over a 28-day period. The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of EDP514 or placebo at our clinical trial sites in Hong Kong and Taiwan, which are both areas with a large unmet need for HPV treatment. As we continue to monitor the impact of COVID-19 in these regions, We expect preliminary data from this trial in the first half of 2021. We've also resumed our ongoing randomized, double-blind, placebo-controlled Phase 1B study in chronic HPV patients treated with nucleoside reverse transcriptase inhibitors, which we refer to as nuke-suppressed patients. This study, which was paused in March due to the COVID-19 pandemic, is part two of our Phase 1A, 1B study. Part 2 is designed to evaluate the safety, colorability, pharmacokinetics, and antiviral activity of orally administered multiple ascending doses of EDP514 over a 28-day period. The study is planned to enroll 24 subjects who will be randomized to receive one of three multiple ascending doses of EDP514 for a placebo. For any further COVID-19 disruptions, we plan to have preliminary data in the second quarter of 2021. As a reminder, we plan to present first in human data from part one of the phase one study in Healthy Volunteers in a poster presentation at EASL's Digital International Liver Congress being held August 27th through the 29th. Let's turn now to EDP938 and our program for respiratory syncytial virus, or RSV. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults at a condition for which there is currently no safe and effective therapy. EDP938 is a potent non-fusion inhibitor of RSV-A and RSV-B, has been shown a significant reduction in viral load and symptom resolution in top-line data from a Phase II human challenge study. We are currently initiating sites in the southern hemisphere for RSVP, our ongoing Phase IIb study of EDP938, and are also keeping our existing North American sites ready for reactivation with the arrival of the fall and winter RSV season as well as adding a number of new sites in Europe. RSVP is a Phase IIb double-blind placebo-controlled study of EDP 938 designed to mill approximately 70 subjects up to the age of 75 years randomized to receive either 800 milligrams of EDP 938 or placebo for five days. The primary objective of the study is to evaluate the effect of EDP 938 on the progression of RSV infection by assessment of clinical symptoms measured over the course of the 14-day study observation period, and any viral efficacy will be evaluated as a key secondary endpoint. Well, it's too early to know what impact COVID-19 will have on RSVP timelines. Assuming full study enrollment in the northern hemisphere this upcoming winter, we would expect to have data in the third quarter of 2021. Meanwhile, we are on track to initiate two additional Phase II studies with EDP938, one in pediatric patients and one in adult transplant patients, by the end of this year, concurrent with the RSVP study. The pediatric trial will be a Phase II randomized, double-blind, placebo-controlled, dose-ranging study of EDP938 to evaluate EDP938 regimens in hospitalized or non-hospitalized infants and children aged 28 days to 24 months who test positive for RSV based on an approved diagnostic assay. The adult transplant study is a phase IIb randomized double-blind placebo-controlled study of EDP938 to evaluate the effect of EDP938 in adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract. Turning to the rest of our virology franchise, we remain focused on developing a candidate for SARS-CoV-2. We are utilizing our core strength and compound optimization in drug development to understand the virus and identify vulnerabilities to exploit intracellular targets using, for example, protease inhibitors and polymerase inhibitors. These are direct-acting antivirals, often referred to as DAAs. As with RSV, we believe these DAAs should be more effective than entry inhibitors in stopping the virus after patients already show symptoms of infection. Chemistry and biology efforts are actively ongoing, and we hope to make important progress throughout the remainder of the year. Moving on to our second emerging program, earlier this year we also introduced a drug discovery program for human metapneumovirus, also known as HMPV. Similar to RSV, HMPD is 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. We continue to perform optimization of our current nanomolar HMPD inhibitor leads and are aggressively working to identify our first clinical candidate for this indication. Shifting gears to our work in non-viral liver disease, Where we currently focus on NASH, we are conducting clinical studies of EDP305, our first FXR agonist. Based on data from Argon1, which will be highlighted in an oral presentation at EASL later this month, we initiated recruitment in Argon2 in July. Argon2 is a Phase IIb randomized, double-blind, placebo-controlled, 72-week study in approximately 340 subjects with biopsy-proven NASH. The primary endpoint of Argon-2 will be improvement of fibrosis without worsening of NASH and or NASH resolution without worsening of fibrosis. We are using EDP-305 doses of 1.5 milligrams and 2 milligrams, which we selected to provide strong target engagement and a balanced profile in terms of efficacy and tolerability. Argonne 2 will include a 12-week interim analysis, which we are targeting for mid-year 2021, to assess that balance and to generate dose information more quickly for potential combinations with other mechanisms in NASH. We are additionally developing EDP297, our follow-on FXR agonist candidate for NASH. We're pleased to be on track to initiate a Phase 1 study of EDP297 later this quarter and expect data in the second quarter of 2021. We're excited about EDP297, given compelling preclinical data that demonstrate its high potency and tissue targeting characteristics compared to other FXR agonists in development. Specifically, EDP297 is targeted to tissues important for efficacy, namely liver and intestine versus plasma and skin. We believe that a highly potent highly selective and tissue-targeted FXR agonists may allow for lower effective doses and an improved tolerability profile. We plan to present two posters on the preclinical profile of EDP297 at Edelpeat at Easel later this month. I'd like to conclude my remarks by emphasizing a few key takeaways. We look forward to moving our HPV trial and viremic patients forward with preliminary data anticipated in the first half of 2021. We also look forward to preliminary results from our Phase 1b trial on HPV patients who are nuked suppressed by the second quarter of the year. We are pleased that the RSVP trial is continuing in the Southern Hemisphere. We are ready to return to sites in North America while adding additional sites in Europe during the coming fall and winter RSV season. We're also eager to begin our two other RSV studies on both pediatric patients and adult transplant patients next quarter. And finally, we're excited about advancing our candidates in MASH, where we were able to initiate the Argonne 2 trial of EDP 305 and are on track to initiate the Phase 1 study of EDP 297 this quarter. I'll stop here and turn the call over to Paul to discuss our financials for the quarter. Paul?