Atea Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen. Welcome to Atea Pharmaceuticals' second quarter 2021 financial results conference call. At this time, all participants are in listen-only mode. Following the formal remarks, we will open up for your questions. I would now like to turn the call over to Jonay Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Please proceed.

Thank you, Operator. Good afternoon, everyone, and welcome to Attea Pharmaceutical's second quarter 2021 financial results conference call. This afternoon, we issued a press release which outlines the topics that we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the investor section of our website at ir.atteafarma.com. With me today from Attea are founder, chairman, and chief executive officer, Dr. John Pierre Somadosi, Chief Development Officer, Dr. Jim Hammond, Chief Financial Officer, Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Vavrica. They will all be available for the Q&A portion of today's call. On the call today, we have a lot of important content to review. John here will provide an overview on the current COVID-19 environment and AT527's potential to address these key challenges. Janet will review our clinical progress and results. for AT527 for the treatment of COVID and discuss AT752 for the treatment of dengue fever. John will then provide an overview of the U.S. commercial opportunities for AT527. Andrea will provide a financial update. And John Pierre will provide closing remarks. Before we begin the call, I would like to remind you that today's discussion will contain forward-looking statements that involve risk and securities. These risks and uncertainties are outlined in today's press release. and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jean-Pierre.

Jean-Pierre Jean- Thank you, Isamay. Good afternoon, everyone, and thank you for joining us today. I will begin on slide three of the presentation. Since Atea founding, we have remained steadfast in our mission to discover and develop antiviral drugs for the treatment, cure, and prophylaxis of severe viral diseases where there is a significant unmet medical need or where we can make a meaningful impact for patients. Early last year, our antiviral platform put us at the forefront in the fight against COVID-19. And we believe a multi-pronged approach, including therapeutics and vaccine, will be essential solutions in this pandemic which is now becoming endemic. It has become abundantly clear that most countries and regions like Southeast Asia, South America, and India, where we are seeing a devastating impact from COVID of low vaccination rates, which have become a source for variants and create new challenges for treatment and prevention. It is projected that the Delta variant currently accounts for 93% of all new cases in the United States, and we are now back to 100,000 new infections per day. Obviously, this is of particular concern given recent publications demonstrating lower efficacy rates for vaccines against the new strain. For example, the Delta variant has also been reported to be highly contagious, almost as contagious as chickenpox, and it has a more rapid replication than earlier strains. And for this, we are seeing a significant number of breakthrough cases in vaccinated, fully vaccinated patients, accounting for as much as 15% in all hospitalized patients, and even 15% of the new cases now are in children, which further expand the infected population. In addition to the Delta variant, the Lambda variant, first identified in Peru and now spreading in South America, is highly infectious as well. And particularly concerning, and I'm sure that in six months or so, we will probably talk about another dominant variant in the U.S. and other countries. Turning to slide four, given this evolving dynamics, mentioned that oral therapeutics in particular will be essential in stemming the tide of this pandemic. We believe that 85 to seven, our early administered Direct acting antiviral agent derived from our purine nucleotide project platform is uniquely positioned to help meet this challenge and become a solution. As I'm sure by now you know, 8527 targets viral RNA polymerase, which is a highly conserved enzyme critical to viral replication and transcription. And this dual mechanism affecting both functional domains of this RNA polymerase, inhibiting both NIRAND and the LDRP. We believe that we provide a high barrier to resistance along with broad antiviral coverage for different variants of SARS-CoV-2. To date, the predominant mutation actually in this RNA polymerase is the P323L. And please note a baseline, you know, hospitalized phase two trials, 98% of the patient had this mutation. And we believe that all responded to 85 to seven treatment. Essentially we can say today that there is the original war viruses is basically gone. And we believe that This bodes very well for antiviral activity against the variants as well, and we are currently validating this hypothesis. As reported in recent press releases, a significant amount of compelling clinical data has been reported for our drugs, demonstrating antiviral efficacy in our Phase II study in hospitalized patients. And today, Janet will review the Phase II interim results as well as new data from a bronchial alveolar lavage study demonstrating that 85 to 7 we believe is the first investigation of DAA being developed for COVID-19 and showing that target drug levels effectively reach the lung which as you know is the primary site of SARS-CoV-2 infection. I want to emphasize that this is the lower respiratory tract in contrast where we are measuring The RNA, as Janet will show you and share with you the data, we are talking about upper respiratory tract. So that's why we've used this data. It's very important for our development program as they provide further confidence, not only for the treatment, but also for our planned prophylaxis studies for COVID-19. As we continue to advance multiple global clinical studies in parallel with our partner Roche, we are one step closer to achieving our goal of providing an easily administered or direct acting and derailing the fight against this global pandemic. And now I would like to turn the call to Janet for a full review of this data. Janet?