Enanta Pharmaceuticals, Inc.

Good afternoon and welcome to Enanta Pharmaceutical's first 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 conference over to Jennifer Vieira, Investor Relations. Please go ahead.

Thank you, Operator, and thank you to everyone for joining us this afternoon. The news released with our fiscal first quarter financial results was issued this afternoon and is available on our website. On the call today is Dr. Jay Lulai, 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 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. Ananta 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 Lulli, President and CEO. Jay?

Jay Lulli, President and CEO, Thank you, Jennifer, and good afternoon, everyone. Our fiscal first quarter was an exciting and productive time for Enanta as we continue to advance our robust, wholly-owned pipeline. We currently have six ongoing clinical trials, two in respiratory syncytial virus, two in hepatitis B, and two in non-alcoholic steatohepatitis, as well as three respiratory virus discovery initiatives, including a recently announced RSV-L inhibitor to complement our HMPV and COVID-19 programs. We also recently introduced a new selective oral HPV RNA destabilizer that is advancing toward the clinic mid-year. I'd like to take a moment and acknowledge the commitment and dedication of our employees who continue to go above and beyond, contributing to the significant pipeline progress we have made across our business. We continue to build out our team with talented individuals and just this quarter made three significant new hires who will contribute to the company's growth. We look forward to the contributions over the coming months as we approach several significant milestones. In December, Dr. Tara Kiefer joined us from Vertex as Senior Vice President of New Product Strategy and Development. Tara brings over 20 years of scientific expertise in infectious diseases and product development. In January, we announced Dr. John DiVincenzo, one of the most highly regarded investigators in respiratory syncytial virus, will be joining the ANANTA team. For the past 30 years, John has played a significant role in many of the major RSV clinical trials. Most recently, we were pleased to announce Brendan Liu as our Senior Vice President of Business Development, a role to which he brings 20 plus years of diversified business development and sales and marketing experience in the pharmaceutical and technology industries, most recently at Merck KGAA. Turning to our pipeline, I'm excited to review the progress of the past quarter in more detail and share our plans for multiple catalysts throughout 2021. I'll start with RSV, where we are advancing a robust clinical development program consisting of two ongoing studies and one planned study of EDP938, the only RSV inhibitor in clinical development today. RSV is a severe respiratory infection associated with significant morbidity and mortality in infants, the elderly, and immune-compromised adults, in a condition for which there is currently no safe and effective therapy. Globally, there are an estimated 33 million cases of RSV annually in children less than five years of age, with about 3 million hospitalized and and approximately 118,000 dying each year from complications associated with the infection. The first of our ongoing studies is RSVP, a Phase IIb double-blind placebo-controlled study of EDP938 designed to enroll approximately 70 subjects who are randomized to receive either EDP938 or placebo for five days. Currently, the RSV season in the Northern Hemisphere has not begun, due to the continuing COVID-19 mitigation measures. We believe that when these measures subside, RSV will reemerge, and recent modeling is even predicting large future outbreaks of respiratory viruses, especially influenza and RSV. In fact, this has already occurred in New South Wales, Australia's most populated state, where a recent government surveillance report showed a steep increase in RSV rates that experts believe was due to relaxed social distancing measures. Further, the RSV rates were even higher than the usual average peak in the last five years, despite being delayed by several months. And this peak occurred in Australia's summer season when these cases are usually low. Also, the scarcity of RSV cases during the pandemic is breaking the chain of immunity in children who normally get repeated exposures of RSV and build resistance in the first few years of life. This has allowed for a larger vulnerable patient population, which experts believe may result in higher than average levels of RSV when the virus reemerges. That said, we believe RSV will reemerge and our strategy is to be ready across the globe with clinical trial sites ready to go when the hotspots emerge. For example, we are setting up trial operations for RSVP, not only in North America, but also in Europe, the Pan-Asia Territory, and the Southern Hemisphere, aiming to more than double the number of sites globally. We'll provide updated guidance on RSVP timelines as RSV becomes prevalent again. Turning to our other RSV clinical trials, in December we initiated RSV-TX, a global multicenter Phase IIb randomized double-blind placebo-controlled study evaluating the efficacy and safety of EDP938, in adult hematopoietic cell transplant recipients with acute RSV infection of the upper respiratory tract. The study is designed to enroll approximately 200 adult subjects with the primary objective of evaluating the effect of EDP938 on development of lower respiratory tract complications in these transplant patients who will receive EDP938 or placebo for 21 days and then be followed for 28 days. We're also currently planning to initiate our third RSV phase two study, RSV-Peds, later this quarter. This is a global multi-center phase two, double-blind, placebo-controlled, dose-ranging study of EDP938 in children aged 28 days to 24 months. It is designed to enroll approximately 90 hospitalized or non-hospitalized infants and children with RSV. The study will have two parts. In part one, The primary objective is to evaluate the safety and pharmacokinetics VDP938 in multiple ascending doses in four age cohorts, oldest to youngest, while the objective in part two is to assess the antiviral effects against RSV. In each part, subjects will be dosed for five days and then followed for 23 days. Beyond these three trials, we are excited about the expansion of our RSV program with the introduction of RSV-L protein inhibitor discovery initiative that includes potent animal or leads against both RSV-A and RSV-B. Similar to 938, we are focusing on replication inhibitors as this non-fusion approach directly targets viral replication as opposed to viral entry. RSV-L inhibitors are not expected to have cross resistance to other classes of inhibitors and therefore can potentially be used alone or in combination with agents targeting different RSV mechanisms, such as EDP938, to possibly broaden the treatment window or the eligible patient population. Our respiratory virology discovery efforts are also urgently focused on developing targeted antiviral therapeutics for SARS-CoV-2. Recently, several new variants of the original virus have been identified, initially emerging in the UK, South Africa, and Brazil, which may have some impact on the activity of current monoclonal antibodies and vaccines. These variants have mutations in the spike protein that potentially allow the virus to spread more readily or evade the immune system. Our antiviral discovery program targets conserved regions and enzymes essential for viral replication, So mutations in the spike protein are not expected to affect the activity of our inhibitors. We expect the emerging variants to retain full sensitivity to our inhibitors and are currently in the process of confirming this preclinically. Among our respiratory virology discovery programs, which include RSVL protein, SARS-CoV-2, and human metapneumovirus, we have nanomolar inhibitors undergoing lead optimization in each And our plan is to nominate clinical candidates in two of these three programs in 2021. Let's move on to our Hepatitis B program, where we are evaluating EDP514, our lead core inhibitor, in chronic HPV patients treated with a nucleoside reverse transcriptase inhibitor, referred to as nuke-suppressed patients, as well as in chronic HPV-infected patients with high viral loads not currently on treatment. which we refer to as viremic patients. Each trial is a randomized double-blind placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, antiviral activity of one of three orally administered multiple ascending doses of EDP514 compared to placebo over a 28-day period in up to 24 randomized patients. We plan to have preliminary data from both trials next quarter. Last month, we were excited to announce the expansion of our HPV program to include our newest clinical candidate, EDP721, a potent and selective oral HPV RNA destabilizer. It has the potential to reduce production of multiple HPV proteins, which we believe could be a key component in achieving a functional cure for chronic HPV. We recognize this may take a multi-drug approach involving mechanisms to stop viral replication, and inhibits surface antigen, also referred to as S antigen. Nukes are the current standard of care, and they are reasonably effective at suppressing HPV replication. EDP-514, our core inhibitor, affects several stages of HPV replication, from uncoating and nuclear import of the virus to capsid assembly and recycling. And our new oral agent, EDP-721, that can destabilize HPV RNAs, leads to a reduction in viral proteins, including S antigen. Last month, we shared compelling data demonstrating a three-log reduction in S antigen levels with EDP721 and a mouse model which demonstrated equal or superior efficacy to siRNA-based and antisense oligo-based agents tested in the same model. With EDP721 now in our portfolio, we see the opportunity for an all-oral functional cure, and we look forward to initiating a Phase I clinical study of this exciting new candidate by mid-year. Moving on to our work in non-alcoholic steatohepatitis, or NASH, our first FXR agonist, EDP305, is in an ongoing Argon-2 Phase IIb randomized double-blind placebo-controlled 72-week study in approximately 340 subjects with biopsy-proven NASH with fibrosis. The primary endpoint of Argon-2 is improvement of fibrosis without worsening of NASH and or NASH resolution without worsening of fibrosis. While good target engagement and tolerability were observed with the 1 milligram dose in Argon-1, with Argon-2, we are exploring doses of 1.5 and 2.0 milligrams to determine what additional dose or doses may also favorably balance target engagement with tolerability. In mid-2021, we will have an internal interim analysis of 12 weeks of treatment in a subset of patients, at which point we expect to have more information to determine what dose or doses we move forward for potential combinations through partnering. We are also developing EDP297, our oral follow on FXRA units for NASH with potentially best in class potency and tissue targeted effects. It's currently being studied in a phase one randomized double-blind placebo controlled first in human trial designed to assess the safety, tolerability and pharmacokinetics in approximately 74 healthy adult subjects. We look forward to reporting clinical data in mid 2021. So in mid-2021, we expect to have important insights for both EDP 305 and EDP 297. We'll be positioned to prioritize these assets and define the optimal go-forward strategy. I'd like to conclude my remarks by emphasizing a key few points. It's been an especially active time for Inanta as we continue to progress and expand our wholly-owned pipeline. Over 2021, we look forward to several catalysts, including the initiation of a Phase I clinical study of ADP721, our HPV RNA destabilizer, by mid-2021, and preliminary data for both Phase I studies of ADP514 in HPV patients in the second quarter of 2021. Further, when looking toward our respiratory virology discovery efforts, we anticipate nominating two new clinical candidates this year among our HMPV, SARS-CoV-2, and RSV programs. Finally, in NASH, with the Argonne 2 trial of EDP305 and the Phase 1 study of EDP297, we look forward to having valuable insights mid-year to inform next steps. I'll stop here and turn the call over to Paul to discuss our financials for the quarter.