Enanta Pharmaceuticals, Inc.

Good afternoon and welcome to Enantez Pharmaceuticals Fiscal Fourth Quarter and Full Year Ended September 30th, 2022 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'll now like to hand 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 fourth quarter and full year 2022 financial results was issued this afternoon and is available on our website. On the call today are 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 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?

Thank you, Jennifer, and good afternoon, everyone. At Enanta, we are leveraging our expertise in medicinal chemistry, virology, and preclinical sciences to discover new compounds that can be developed into groundbreaking medicines. Our fiscal fourth quarter, as well as 2022 overall, was a year of progress toward this effort. With multiple ongoing and planned clinical studies across our pipeline, we are poised to execute on our vision to transform the lives of patients with curative therapies, building on our prior success in hepatitis C. Today, I'll start by detailing our recent advances in the development of EDP-235, our once daily orally dosed inhibitor of coronavirus 3CL protease, which is in clinical development for the treatment of COVID-19. I will then comment on our RSV and human metapneumovirus pipeline progress since our last call, as well as our work in hepatitis B. Starting with COVID-19, we are pleased with the recent advancement of EDP-235 into the next stage of clinical development with the initiation of SPRINT, a Phase II clinical trial in COVID-19 patients. This randomized double-blind placebo-controlled study will enroll approximately 200 non-hospitalized symptomatic patients with mild to moderate COVID-19 who are not at increased risk for developing severe disease. Patients will receive 200 milligrams or 400 milligrams of EDP-235 or placebo orally once daily with food for five days and will be followed for 28 days thereafter. Patients will be eligible to participate if they have had symptoms for not more than five days and have not received a SARS-CoV-2 vaccine or been infected with SARS-CoV-2 within 90 days of enrollment. Primary objective of the study is safety and tolerability, and key secondary objectives include pharmacokinetics and multiple virologic measures to guide our dose selection for subsequent trials. In other studies of protease inhibitors, the viral load decline has been similar between high and standard risk populations. Thus, we believe enrolling from a larger pool of standard risk patients will be a more efficient way to collect this information. We are aiming to report results from SPRINT in the first half of 2023. As previously reported, data from the Phase 1 study of EDP-235 demonstrated it was generally safe and well-tolerated up to 400 milligrams for seven days with strong exposure multiples over the EC90, which is a measure of potency. Specifically, it is a concentration of the drug that results in 90 percent inhibition of viral replication in vitro. Adverse events were generally mild and infrequent. Two hundred milligrams of EDP-235 taken once daily resulted in mean trough plasma levels at steady state that were threefold and sevenfold over the plasma protein-adjusted EC90 for the Alpha variant and Omicron variant, respectively. while 400 milligrams resulted in levels that were six-fold and 13-fold over the plasma protein-adjusted EC90 for the respective variants. Importantly, these target exposure multiples were achieved without the need for ritonavir boosting and its associated drug-drug interactions. Based on preclinical studies, EDP235 is projected to have four times higher drug levels in lung tissue compared to plasma, which would be expected to drive up to a 28-fold multiple for the Omicron variant at even the 200 milligram human dose. As COVID-19 persists and new variants arise that can circumvent immunity from vaccination, previous infection, or monoclonal antibody treatments, we are committed to developing EDP-235 as a convenient and easily prescribed antiviral which continues to show strong activity against all COVID-19 variants tested to date. Beyond COVID-19, we are also encouraged by the progress we have made in our Respiratory Syncytial Virus, or RSV program. RSV is a virus that represents a significant unmet need as it can result in a severe respiratory infection and is associated with significant morbidity and mortality in children, the elderly, and other high-risk populations. While RSV was mitigated for some time due to social distancing measures during the pandemic, RSV infections are now on the rise in the U.S., and the need for a treatment remains high, as there are no targeted therapeutics currently available. We are pursuing a robust RSV program, which includes EDP938, the most advanced N-protein inhibitor in clinical development today, as well as EDP323, a novel oral therapeutic targeting the RSVL protein RNA polymerase. We're currently evaluating EDP938 in high-risk populations, including pediatric patients, adult hematopoietic cell transplant recipients, and other high-risk adults, all of which have a significant unmet need. Last month, we initiated RSVHR, a Phase IIb study in adults with acute RSV infection who are at high risk of complications, including those over 65 years of age and or those with congestive heart failure, COPD, or asthma. The study is a randomized, double-blind, placebo-controlled, multicenter global study designed to evaluate the effect of EDP938 compared with placebo on the progression of RSV infection. Approximately 180 patients will be treated with 800 milligrams of EDP-938 or placebo for five days and then evaluated over the next 28 days. The primary endpoint for the study is time to resolution of RSV lower respiratory tract disease symptoms through day 33. Our other studies of EDP-938, namely RSV-PEDS, a phase two study in pediatric RSV patients, and RSV-TX, a Phase IIb study in adult hematopoietic cell transplant recipients with RSV, are ongoing. We believe EDP938 has the potential to deliver a potent oral antiviral treatment for all populations at high risk from RSV infection. We'll continue to monitor the RSV trends during this northern hemisphere season to enable us to better evaluate timing for data. This quarter, we also began dosing in our phase one randomized double-blind placebo-controlled study of EDP323 in healthy adult subjects. The study will evaluate the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP323, our novel oral therapeutic targeting the RSVL protein RNA polymerase. EDP323 is supported by promising preclinical data presented this quarter at the 12th International RSV Symposium, which showed that EDP323 inhibited polymerase activity in vitro and also inhibited the virus-induced cytopathic effect of both RSV-A and RSV-B strains. In a rodent RSV infection model, treatment with EDP323 was associated with improved lung histopathology and dose-dependent reductions in pro-inflammatory cytokines. We believe EDP-323 could serve as a standalone treatment or may be used in combination with other agents such as EDP-938, potentially broadening the treatment window or addressable patient populations for RSV. Moving on to our respiratory discovery program in human metapneumovirus, or HMPV, which is a virus that is similar to RSV and impact several vulnerable populations, including the elderly, adults with underlying pulmonary disease, and those who are immune compromised. This quarter, we presented preclinical data at the 12th Annual RSV Symposium, highlighting advancements in HMPV detection, quantification, and growth methods for the generation of an improved toolkit for the in vitro characterization of multiple HMPV strains. Our goal is to select a development candidate for HMPV next year. Turning to hepatitis B, our goal remains to develop a functional cure for chronic HPV patients. We continue to evaluate internal and external opportunities for additional candidates to develop in combination with EDP514, as we believe the ultimate cure for this infection will involve combination therapy. Our commitment is based on the continued high unmet need for this disease which is a global public health threat and the world's most common serious liver infection, making it the primary cause of liver cancer, also known as hepatocellular carcinoma, or HCC, the second leading cause of cancer deaths in the world. We believe that a core inhibitor such as EDP514 could ultimately be an integral component of a successful combination regimen. Finally, I'd like to wrap up by highlighting our near-term clinical milestones for the first half of next year. We look to progress SPRINT as quickly as we can through Phase 2 and to report data in the first half of 2023. Further, we expect to have data from our Phase 1 study of EDP323, our RSVL inhibitor, also in the first half of 2023. With that, I'll turn the call over to Paul to discuss their financials.