Enanta Pharmaceuticals, Inc.

Good afternoon, and welcome to Enanta Pharmaceuticals Fiscal Second Quarter 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 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 2022 financial results was issued this afternoon and is available on our website. On the call today are 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. With that, I'd now like to turn the call over to Dr. Jay Lulai, President and CEO. Jay?

Jay Lulai Thank you, Jennifer, and good afternoon, everyone. Last quarter was an important one for Ananta during which we made progress in our pipeline and advanced our mission of developing therapeutics for life-threatening viral infections. This progress comes at an important time. as we are soon approaching meaningful inflection points in our pipeline. Today, I'll start by detailing our most advanced programs in respiratory virology, where we continue to build an industry-leading treatment portfolio. Respiratory syncytial virus, or RSV, can result in a severe respiratory infection and is associated with significant morbidity and mortality. The virus can cause serious disease in children, the elderly, and the immune-compromised and there are no targeted treatments or vaccines available. Our robust RSV program includes EDP938, the most advanced N-protein inhibitor in clinical development today, as well as our newest clinical candidate, EDP323, a potent L-protein inhibitor. We're excited by the potential of EDP938, which currently is in three Phase II studies in different patient populations. EDP938 is an oral, potent molecule that has shown robust clinical data in a Phase II challenge study where it was safe and well-tolerated and resulted in a significant decline in viral load and reduced symptoms of infection. Our leadership in RSV is further highlighted by the recent publication of the results of the challenge study in the New England Journal of Medicine. Our most advanced study of EDP938 is RSVP, a Phase IIb trial and otherwise healthy adults with community-acquired RSV infection. The study was designed to confirm in a community-acquired setting the positive results of our Phase IIa challenge study and to further characterize efficacy by measuring symptom alleviation and viral load decline. Enrollment in RSVP is now complete. We are on track to report top-line data from this study later this quarter. Our two other ongoing studies are RSV-PEDS, a Phase II study in pediatric RSV patients, and RSV-TX, a Phase IIb study in adult hematopoietic cell transplant recipients with RSV. Both are expected to recruit into 2023. Moving forward, our broad clinical development pipeline for EDP938 will focus on evaluating its potential in populations with greatest unmet need. namely those who are at high risk for severe disease. This includes children, the elderly, adults with other high-risk conditions, and the immune compromised. To that end, we are also planning to initiate another Phase IIb study in high-risk adults, including the elderly and those who have asthma, COPD, or congestive heart failure. We expect to initiate this study in the fourth quarter of this year. We're excited to add this study to our clinical development program as we believe EDP938 has potential to deliver a potent oral antiviral treatment for all high-risk populations. Indeed, we believe these high-risk patients would benefit the most from antiviral treatment with EDP938. They represent populations in which an even greater benefit is likely to be observed since they have suboptimal RSV immunity, and manifest much greater RSV disease severity and mortality, allowing demonstration of the full potential of EDP938. Adding to our robust RSV portfolio, in February, we introduced EDP323, a novel oral antiviral therapeutic targeting the RSVL protein RNA polymerase. Preclinical data have shown that EDP323 has sub-nanomolar in vitro potency against major subtypes of RSV, RSV-A and RSV-B, and is not expected to have cross-resistance to other classes of inhibitors. Additionally, in preclinical studies, EDP-323 has shown strong oral absorption and good plasma exposure across different species. We believe EDP-323 could serve as a standalone treatment or may be used in combination with other agents, such as EDP938, to potentially broaden the treatment window or addressable RSV patient populations. And we plan to initiate a Phase I study of EDP323 in the second half of this year. Turning to SARS-CoV-2, we're making strong progress with EDP235, our oral inhibitor of the 3CL protease, also referred to as the main protease, or MPRO. EDP-235 is specifically designed to be a once daily oral treatment for COVID-19 without the requirement for ritonavir boosting. Novel variants of SARS-CoV-2 are continuing to emerge, causing new waves of COVID-19 cases globally. This highlights the need for conveniently dosed oral therapeutics, especially given the suboptimal vaccination rates decreased protection against new variants, and waning immunity observed to date with the current boosters. We believe EDP-235 has the potential to be a best-in-class treatment for COVID-19 based on the preclinical data demonstrated to date, which positions it amongst the most potent direct-acting antivirals currently in development for SARS-CoV-2 infection. In March, the FDA granted fast track designation for EDP235, further highlighting the potential for EDP235 and emphasizing the urgent unmet need that exists for COVID-19 treatments. Last month, we presented data on EDP235 in vitro pharmacology and molecular mechanism of action at the annual meeting of the American Society for Biochemistry and Molecular Biology. These preclinical data demonstrated that EDP-235 is a potent inhibitor of SARS-CoV-2 3CL-pro with nanomolar antiviral activity against SARS-CoV-2 variants of concern, including the Delta and Omicron variants. EDP-235 also showed potent antiviral activity against most other pathogenic human coronaviruses, potentially making it a pan-coronavirus therapy. We are on schedule to report preliminary data from our phase one study of EDP235 later this quarter. This first in human single and multiple ascending dose ranging study is evaluating the safety, tolerability, and pharmacokinetics of EDP235 in healthy volunteers after once daily dosing without ritonavir. If supported by phase one results, we plan to advance EDP235 to the next stage of clinical development in the second half of this year. We also continue to pursue our respiratory discovery program in human metapneumovirus, or HMPV, a virus that is similar to RSV and impacts a number of vulnerable populations, including the elderly, adults with underlying pulmonary disease, and those who are immune compromised. We are nearing completion of lead optimization of potent nanomolar HMPV inhibitors and plan to select a clinical candidate in the second half of this year. Moving to hepatitis B, we remain committed to developing a combination regimen as a functional cure for chronic HPV patients. EDP514, our core HPV core inhibitor with fast-track designation, has demonstrated safe and potent antiviral activity in two Phase I studies in different chronic HPV patient populations. those who have high viral load, whom we refer to as viremic patients, and those who are on a treatment with a nucleoside reverse transcriptase inhibitor, whom we refer to as nuke-suppressed patients. These data suggest EDP514 has the potential to be a best-in-class core inhibitor for HPV. We remain focused on evaluating internal and external opportunities for additional components with alternative mechanisms to develop in combination with EDP514, as we believe that a core inhibitor such as EDP514 will ultimately be an important component of a successful combination regimen. Before moving to the financials, I'd like to wrap up by highlighting our near-term milestones. We plan to report data from RSVP this quarter and look forward to initiating a new Phase II RSV study in high-risk adults by year-end. We expect to report preliminary Phase I data for EDP235, our oral antiviral specifically designed for the treatment of COVID-19, later this quarter. If indicated by Phase I results, we plan to advance EDP235 to the next stage of clinical development in the second half of this year. We also look forward to initiating a Phase I study for EDP323, our RSVL inhibitor, as well as nominating a clinical candidate for human metapneumovirus in the second half of this year. With that, I'll turn the call over to Paul to discuss our financials. Paul?