Enanta Pharmaceuticals, Inc.

Good afternoon and welcome to the Ananta Pharmaceuticals Fiscal First 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 first quarter 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 the NANTA'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. Anantha 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. Anantha had a very productive fiscal first quarter of 2022, as we made significant progress in our RSV and COVID-19 programs. building a strong foundation for important inflection points to come this year. Today, I'll update you on our clinical development programs for respiratory syncytial virus, SARS-CoV-2, and hepatitis B virus, all of which have the goal of providing safe and effective oral antiviral treatments for viral diseases infecting broad patient populations. I will additionally comment on our ongoing discovery efforts and progress in human metapneumovirus. Ananta has a successful and proven history of discovering and developing antiviral treatments, as demonstrated by Glicaprovir, the HCV protease inhibitor component, and Maverick, a leading treatment for chronic hepatitis C virus. We have expanded and leveraged this long and deep experience in virology to discover small molecule therapeutics for multiple viruses, recently expanding our respiratory virology pipeline by developing a coronavirus protease inhibitor for SARS-CoV-2 and an L inhibitor for RSV. The pandemic has made it clear that viruses can cause serious disease, which makes our work especially significant. With that backdrop, today I will start by detailing progress in our respiratory virology programs, where we continue to build an industry-leading treatment portfolio. Our most advanced RSV program is our in-protein inhibitor, EDP938, which has fast-track designation and is currently in three Phase II studies in multiple patient populations. Additionally, we continue our leadership in RSV with the announcement of a clinical candidate in our RSV-L inhibitor program, EDP323. As a reminder, RSV is a severe respiratory infection associated with significant morbidity and mortality. The virus can cause serious disease in children, the elderly, and the immune compromised, and there are no treatments or vaccines available for the virus, which was first characterized in 1956. We were excited by the potential of EDP938, which is a potent inhibitor of the RSVN protein that has shown robust clinical data in a Phase IIa challenge study, where it was not only safe and well tolerated, but also demonstrated significant effects on viral load and reduced symptoms of infection. In this human challenge study of EDP938, we met the primary endpoint of viral load reduction and also a key secondary endpoint of total symptom score. In order to confirm our findings outside of a challenge study setting, we conducted the RSVP study to evaluate EDP938 in an adult outpatient population infected with community-acquired RSV, and to provide us additional information on symptom alleviation and viral load decline. Following a period of decreased RSV transmission due to social distancing measures, late last year there was an uptick in RSV activity in various regions of the world, including parts of the United States and Europe, which allowed us to complete enrollment beyond our initial target of 70 patients. We are on track to report top-line data from RSVP next quarter. Our broad clinical development program includes two key Phase II studies of EDP938, evaluating its safety and efficacy in young children and hematopoietic cell transplant recipients with RSV infections. Our clinical trial named RSVP is a Phase II study in pediatric RSV patients, and the trial RSV-TX is a Phase IIb study in adult hematopoietic cell transplant recipients with RSV. Data from these two studies will confirm the doses to be used in subsequent pivotal studies in these populations. These studies, which were initiated after RSVP, are expected to extend at least into 2023. We are monitoring RSV globally and will be providing further updates as the incidence rates evolve. This quarter, we are pleased to announce that we broadened our footprint in RSV by introducing ADP323, a potent RSV-L inhibitor. ADP323 targets the RSV-L protein, which is a viral polymerase that contains multiple enzyme activities required for RSV replication. Preclinical data demonstrate nanomolar potency across the major RSV subtypes, RSV-A and RSV-B, and good absorption and plasma exposure across multiple different species. We envision EDP-323 as a standalone treatment or for use in combination with other agents such as EDP-938 to potentially broaden the treatment window or expand the addressable RSV patient population. We expect to initiate a phase one study of EDP-323 in the second half of this year. I'm proud of the work we have done thus far in RSV, and I'm excited by the potential of our broad development program, allowing us to extend our leadership in the development of treatment for respiratory viruses. Turning to SARS-CoV-2, we're also excited by the promise of EDP-235, our oral coronavirus 3CL protease inhibitor, also known as a main protease inhibitor, specifically designed for the treatment of COVID-19. EDP-235 is on track to begin dosing subjects this month. This first-in-human, single and multiple ascending dose ranging study will determine the safety, tolerability, and pharmacokinetics of EDP-235 in healthy participants. In preclinical studies, EDP-235 demonstrated highly potent antiviral activity against SARS-CoV-2 and pharmacokinetic properties supporting a once-daily oral dosing regimen without the need for a boosting agent, such as ritonavir, all which indicate the potential of EDP-235 as a best-in-class compound. Specifically, EDP-235 potently blocks the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells with an EC90 of 33 nanomoles. Importantly, ADP235 has shown potent antiviral activity in vitro across a range of currently circulating SARS-CoV-2 variants, including Omicron and Delta, giving it pangenotypic potential. Furthermore, ADP235 has potent activity against other human coronaviruses, enabling the potential for a pan-coronavirus treatment including possibly coronaviruses that may infect human populations in the future. EDP-235 has also shown excellent exposure after oral administration without ritonavir abusing and favorable distribution into key target tissues, including lung and preclinical models. This positions EDP-235 among the most potent direct-acting antivirals currently in development for SARS-CoV-2 infection, with the potential for convenient once-daily dosing. With our phase one study starting this month, assuming supportive data, we would advance ADP235 to the next stage of clinical development in the second half of 2022. We also continue to pursue our respiratory virus discovery program in human metapneumovirus, or HMPV, a virus that was first identified 20 years ago and now circulates worldwide with nearly universal infection by age five. Like with RSV, there are a number of vulnerable populations, including children, 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 our vision of developing a combination regimen to deliver a functional cure for chronic HPV patients. EDP514, our HPV core inhibitor with fast-track designation, has been evaluated in two Phase 1B studies in different chronic HPV patient populations. Those who have a 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 suppress patients. Last year, we presented data demonstrating that EDP514 has clear clinical evidence of a good safety profile alone and in combination with a nuke and displays significant antiviral activity over 28 days with a pharmacokinetic profile consistently supportive of once daily dosing orally putting EDP514 among the best core inhibitors currently in development. We remain focused on evaluating internal and external opportunities for additional compounds 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 reiterating our upcoming milestones. We expect multiple catalysts, including the start of dosing in our phase one study of our oral 3CL protease inhibitor, EDP-235, this month. If supported by phase one results, we plan to advance EDP-235 to the next stage of clinical development for the treatment of COVID in the second half of this year. We plan to report top line data from the RSVP study of EDP938 next quarter. Finally, we look forward to initiating a phase one study for EDP323, our RSVL inhibitor, and nominating a human metapneumovirus clinical candidate in the second half of this year. With that, I'll stop here and turn the call over to Paul to discuss the financials. Paul?