Enanta Pharmaceuticals, Inc.

Good afternoon and welcome to Enanta Pharmaceuticals Fiscal Second Quarter 2021 Financial Results Conference Call. At this time, all participants are in a 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 would now like to turn the call over to Jennifer Vieira, Investor Relations. Please go ahead.

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

Jay Lulli Thank you, Jennifer, and good afternoon, everyone. Our fiscal second quarter marks another productive quarter for the company. as we continue to work towards several upcoming catalysts across our pipeline in the remainder of the year. We currently have three active clinical programs across our portfolio in virology and liver diseases, in which we are conducting seven clinical trials. Starting with hepatitis B, we are excited to report preliminary data from one of the two ongoing Phase 1B studies of our core inhibitor, EDP514, which I will discuss in more detail shortly. Our HPV program also includes EDP721, our oral HPV RNA destabilizer, which is set to enter the clinic in the middle of this year. Additionally, we have three ongoing studies investigating EDP938 for respiratory syncytial virus, or RSV, and two ongoing clinical studies for two candidates to treat non-alcoholic steatohepatitis, or NASH. Further, we continue to progress our viral respiratory discovery initiatives to identify an L inhibitor for RSV and an inhibitor for human metapneumovirus, or HMPV. Finally, we are particularly enthusiastic about the prospects for an oral protease inhibitor specifically designed to target SARS-CoV-2. With that, I'd like to turn to our robust pipeline, beginning with our HPV program, where we are pleased to be able to report today positive data from the first two dose cohorts of part two of our ongoing phase 1B study of EDP514 in chronic HPV patients treated with a nucleoside reverse transcriptase inhibitor, who we refer to as NUC-suppressed. The data announced today provide critical support for our approach to developing an all oral functional cure for patients with chronic HPV. Based on preliminary results of the phase 1B study, EDP514 was safe and well tolerated and nuke suppressed patients for up to 28 days. And the pharmacokinetic profile of once daily dosing consistent with what was observed in part one in healthy subjects. Going a bit deeper into the data, a total of 16 patients, the majority of whom were e-antigen negative, were randomized to receive 200 milligrams of EDP-514, 400 milligrams of EDP-514, or placebo, for four weeks. There were no grade three or serious adverse events, and the majority of the treatment emergent adverse events were mild. One patient in the 200-milligram arm had a grade II adverse event that led to study drug discontinuation. There were no liver enzyme elevations or other laboratory abnormalities. EDP514 exposure increased linearly with trough concentrations up to 18% of the protein-adjusted ET50, supporting once-daily dosing. As expected, the HPV DNA assessment did not show any change from baseline because these patients already had suppressed DNA levels from their new therapy. Additionally, no virologic failure or breakthrough was observed. Exploratory viral endpoints were also evaluated in this study, and a mean reduction of one log in HPV RNA was observed in patients receiving ADP514 compared to 0.3 log reduction in placebo consistent with data reported for other core inhibitors after four weeks of treatment. Further, maximum reductions of 2.3 logs in the e-antigen negative group and 2.8 logs in the e-antigen positive group were observed in patients receiving EDP514 versus a 1.2 log maximum reduction in the placebo group. The study is ongoing, and we will obtain data on the highest dose group, 800 milligrams, and report final results at a future scientific conference. Later this quarter, we are also expecting preliminary results from our Phase 1B study of chronic HPV-infected patients with high viral load who are not currently on treatment, whom we refer to as viremic patients. Then the NUXA PRESS study, preliminary data in viremic patients will include safety, tolerability, and pharmacokinetics, And importantly, the viremic study will give the first indication of EDP514's effects on viral kinetics when used as a single agent over a 28-day period. In addition, we're developing EDP721, our newest HPV compound, for use in combination with other mechanisms such as nukes and or EDP514 with a goal of creating an all-oral functional cure for chronic HPV infections. Nukes are the current standard of care for HPV patients and suppress HPV DNA. Core inhibitors, such as VDP514, also suppress HPV DNA. In addition, affect several other stages of HPV replication, including uncoating and nuclear import of the virus, capsid assembly, and recycling. However, high levels of HPVS antigen remain a challenge to achieving a functional cure. EDP721 is an oral agent that destabilizes HPV viral RNAs, potentially leading to a reduction in HPV S antigen, as well as other viral proteins in patients. We are encouraged by compelling data showing a three-log reduction in S antigen levels with EDP721 in a mouse model, which demonstrated equal or superior efficacy to SI RNA-based agents and antisense oligo-based agents tested in the same model. We look forward to presenting data on the discovery and characteristics of BDP721 in a poster presentation at this year's International Literate Congress sponsored by EASL in June. And we are eager to start our phase one trial of BDP721 in mid-year with initial results expected in the first half of 2022. Moving to RSV, EDP938, our lead product candidate and the only inhibitor in clinical development today, is currently being evaluated in three ongoing studies. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults, and a condition for which there is currently no safe and effective therapy. Leveraging our expertise in virology, we designed EDP938 to uniquely target the end protein and block the replication machinery of the virus rather than blocking viral entry. As we've mentioned previously, RSV, like flu, did not emerge during the usual late fall and winter RSV season in the northern hemisphere in the past year due to the continuing COVID-19 mitigation measures. However, once social distancing measures subside, likely that RSV will reemerge, as has already been observed in the recent spike of pediatric cases in Australia. With this in mind, we continue our preparedness efforts to ensure we are ready when RSV reemerges globally, including establishing trial sites in North America, Europe, the Asia-Pacific region, and the Southern Hemisphere. These efforts will be Key to recruitment in our clinical trial program, which includes RSVP, our phase 2B study evaluating EDP938 in adults with community-acquired infection. RSVTX, a phase 2 study evaluating EDP938 in adult hematopoietic cell transplant recipients with acute RSV infection and symptoms of upper respiratory tract infection. and RSV-PEDS, a Phase II randomized double-blind placebo-controlled dose-ranging study of EDP938 in pediatric RSV patients. The primary objective of the first part of RSV-PEDS, which we initiated in March, is to evaluate the safety and pharmacokinetics of EDP938 in multiple ascending doses While the primary objective of the second part of the study will be to evaluate the antiviral activity of EDP938. Once RSV becomes prevalent again, we will provide updated guidance for these ongoing clinical studies. Beyond EDP938, our lead optimization efforts in our RSV-L protein inhibitor and human metapneumovirus inhibitor discovery initiatives continue to progress. RSVL inhibitors are another drug class that block replication and can potentially be used alone or in combination with other agents, such as CDP938, to possibly broaden the addressable treatment window or patient population. For HMPV, we are making progress with lead optimization of potent molecules, and our most advanced discovery initiative for respiratory viruses is SARS-CoV-2, where our current efforts to develop an oral, direct-acting antiviral are focused on protease inhibitors and polymerase inhibitors. Building on our virology expertise and success in hepatitis C, we are designing compounds that prevent replication of the virus in human cells versus blocking viral entry, and we expect our approach will be effective against emerging spike protein variants. We plan to initiate IND-enabling studies with our lead oral protease inhibitor later this quarter, and if all progresses positively, we could have a candidate in phase one clinical study in early 2022. I'll end my pipeline review with a summary of our work in NASH, a liver disease with a significant unmet medical need, where we are conducting clinical studies of FXR agonists, EDP305 and EDP297. Recruitment and dosing in Argon-2, our Phase 2b study of EDP305, approximately 340 patients with biopsy-preven NASH with fibrosis, is ongoing. Due to the impact and resurgence of COVID-19 rates in Europe and in South America on some of our global clinical sites, our internal interim analysis based on 12 weeks of treatment on a subset of patients will now be in the third calendar quarter of 2021 rather than in mid-year. Recruitment and dosing are also ongoing in our phase one first human study on our follow-on FXR candidate, EDP297, and we expect to report data from that study in mid-year to build upon compelling preclinical data suggesting differentiated high-potency and tissue-targeting characteristics compared to other FXR agonists and developments. In aggregate, we anticipate that EDP297 data and the EDP305 internal interim analysis will enable us to determine next steps, such as potential combination approaches for our NASH program. Before moving to the financials, I'd like to reiterate our upcoming milestones. In HPB, we expect preliminary results of the Phase 1b study of EDP514 and viremic HPV patients later this quarter, and we look toward the initiation of a clinical trial for SARS-CoV-2-1, our oral HPV RNA destabilizer, in mid-year. For COVID-19, we expect to begin IMD-enabling studies later this quarter for our lead oral protease inhibitor fully designed to target SARS-CoV-2. For NASH, we look forward to reporting preliminary data from the Phase I study of our FXR agonist, EDP297, in the mid-year, followed by an interim analysis of Argon-2 and determination of next steps for this program. Finally, we are excited by the early prospects coming out of our respiratory virology discovery initiatives and are eager to identify two clinical development candidates out of our COVID-19 RSV, and human metapneumovirus programs by year end. With that, I'll stop here and turn the call over to Paul to discuss our financials for the quarter. Paul?