Enanta Pharmaceuticals, Inc.

Good afternoon, and welcome to Enanta's Pharmaceuticals Fiscal Fourth Quarter and Year-End 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 prepared remarks. Please be advised that this call is being recorded. I will now turn the conference over to your host, Ms. 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 year-end 2023 financial results was issued this afternoon and is available on our website. Making formal remarks on today's call are Dr. Jay Lulli, President and Chief Executive Officer, and Paul Mellett, our Chief Financial Officer. Dr. Scott Rottinghaus, our Chief Medical Officer, and Dr. Tara Kiefer, our Senior Vice President of New Product Strategy and Development, will be available during the Q&A portion of the call. 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-K and other periodic reports filed with the SEC. Ananta does not undertake any obligation to update any forward-looking statements made during the call. With that, I'd now like to turn the call over to Dr. Jay Lulli, President and CEO. Jay?

Thank you, Jennifer, and good afternoon, everyone. In fiscal 2023, Ananta took important steps leading to meaningful progress in addressing the unmet need for treating serious respiratory viruses and advancing our business objectives. As we look toward the future, we continue to assess opportunities that will leverage our expertise to transform the lives of patients by discovering novel treatments for viral infections and other diseases. 2024 is shaping up to be an important year for us with multiple inflection points expected, including potential growth into new therapeutic areas. Today, I'll provide an overview of our progress during the fourth quarter, beginning with our respiratory syncytial virus or RSV program, and then I will comment on the rest of our pipeline and give a business update. RSV is a severe respiratory infection associated with significant morbidity and mortality that can cause serious disease in infants, children, and other high-risk populations, including the elderly and individuals with congestive heart failure, chronic obstructive pulmonary disease, or asthma. There remains a significant unmet need for RSV treatments, despite the availability of vaccines and prophylactic monoclonal antibodies that reduce the risk of infection for some high-risk populations. Vaccines will inevitably have suboptimal uptake, and as we've seen with other respiratory viruses, even with adoption, breakthrough infections will still occur. Further, while monoclonal antibodies can provide short-term passive immunity for infants, they will only shift the infant's first infection to the next season. We aim to fill this unmet need for an RSV treatment through the advancement of our broad RSV program, which includes EDP938, the only N-protein inhibitor in clinical development, and EDP323, an L-protein inhibitor, both of which have fast-track designation from the FDA. As such, we are evaluating EDP938 and two Phase II studies, RSV-PEDS and RSV-HR, as a potential treatment in high-risk patient populations. RSV-PEDS is a Phase II randomized double-blind placebo-controlled study in approximately 90 hospitalized and non-hospitalized pediatric patients with RSV aged 28 days to 36 months. It's a two-part study. Because this is the first time the drug is being dosed in pediatrics, the objective of the first part of the study is to evaluate the safety and pharmacokinetics of EDP938 and multiple ascending doses in order to select the optimal dose for each age group. The objective of the second part of the study is to evaluate the antiviral activity of EDP938 at the selected optimal dose. It was designed as a small cohort to show a trend toward improved virology metrics for EDP938 compared to placebo and to give confidence to move forward efficiently into registrational studies. Additionally, we will evaluate symptom scores assessed through the treatment duration. RSV-HR is a Phase IIb randomized, double-blind, placebo-controlled study in adults with RSV infection who are at high risk of complications, including the elderly and individuals with congestive heart failure, chronic obstructive pulmonary disease, or asthma. Approximately 180 patients will be treated with 800 milligrams of EDP-938 or placebo for five days and evaluated over a 28-day period thereafter. The primary endpoint of RSV-HR is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the Respiratory Infection Intensity and Impact Questionnaire, or RIIQ, symptom scale. Secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo, as well as pharmacokinetics and safety of EDP938. In this study, we will be looking for an improvement in time-to-symptom resolution, our primary endpoint, as well as effects on other secondary endpoints, such as antiviral activity. Both studies continue to enroll throughout the global footprint, with RSV-PEDS having over 75 sites across 15 countries and RSV-HR over 130 sites across 16 countries. Our goal continues to be completion of enrollment and at least one of these EDP 938 studies with top line data in the third quarter of 2024, assuming we return to a normal pre-pandemic type of RSV season in the northern hemisphere. We are still early in that season, but initial data are consistent with a more normal season. Also advancing our leadership in RSV, today we announced the initiation of our Phase 2A challenge study of EDP323, an L-protein inhibitor in development as a once-daily oral treatment for RSV. In this randomized, double-blind, placebo-controlled study, up to 114 healthy adult subjects will be infected with the RSV-A Memphis 37B virus and then randomized one-to-one-to-one to receive once daily dosing of either 600 milligrams of EDP-323, 200 milligrams of EDP-323 with a loading dose of 600 milligrams on the first day, or placebo for five days. Primary and secondary outcome measures include safety, changes in viral load measurements, and changes in baseline symptoms. We plan to report data from this study in the third quarter of 2024. The advancement of EDP323 is supported by positive phase one results in which EDP323 demonstrated favorable safety, tolerability, and pharmacokinetics in healthy volunteers. We believe either EDP938 or EDP323 would be effective as a monotherapy, but because the mechanism of action of each is different, we also have the opportunity to use them in combination. Preclinically, the combination of EDP-938 and EDP-323 has additive to synergistic activity. A combination approach would allow us to explore potentially broadening the treatment window or providing additional benefit in specific harder-to-treat populations. In hepatitis B, we believe we need an additional mechanism to develop in combination with EDP-514, our potent core inhibitor with FDA fast-track designation. We think a core inhibitor such as EDP514 could ultimately be an important component of a successful combination regimen and potentially help us address the high level of unmet need in chronic HPV. I'd like to take a moment to acknowledge that we have made important adjustments to our business this year to significantly reduce our 2024 spending and extend our cash runway through fiscal 2027, which Paul will cover in a moment. As previously disclosed, we made the decision to stop RSV-TX, our phase two study in adult hematopoietic cell transplant recipients with RSV infection. We felt it prudent to concentrate our efforts and resources on our pediatric and high-risk adult studies, which comprise the largest patient populations with unmet need and represent the faster paths to market. Furthermore, we made the decision to pause our HMPV RSV dual inhibitor program. While the dual inhibitor has shown significant promise preclinically, we do not plan to move a third RSV compound into the clinic as long as our other two more advanced candidates continue to progress. And as we've mentioned before, we intend to conduct all future work in COVID-19 in the context of a collaboration. These changes allow us to reallocate our focus and resources to diversify our portfolio into other disease areas. We believe this path forward best aligns with our long-term goal at Enanta to deliver highly differentiated therapeutics through innovative chemistry and positions us to provide significant value to patients and our shareholders. To that end, we are excited about the expansion of our research efforts into non-virology indications that leverage our core strength in small molecule drug discovery. We look forward to providing more insight into our progress and announcing new therapeutic programs starting in early 2024. With that, I'd like to wrap up by highlighting our near-term milestones. We look forward to reporting results from our Phase IIa challenge study of EDP323 in the third quarter of 2024. And assuming there is a return to a normal pre-pandemic type of RSV season in the northern hemisphere, we expect to complete enrollment in one or both of our Phase II studies of EDP938 and to have data in the third quarter of 2024. Finally, we will announce new non-virology therapeutic programs beginning in early 2024. Now I'll turn the call over to Paul to discuss our financials. Paul? Thank you, Jay.