2/28/2022

speaker
Conference Operator
Call Moderator

Ladies and gentlemen, please stand by. Your ATSAIA Pharmaceuticals fourth quarter and full year 2021 financials result conference call will begin momentarily. Thank you. Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals 4th Quarter and Full Year 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. I would now like to turn the call over to Ms. Janae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Atea Pharmaceuticals. Please proceed.

speaker
Janae Barnes
Senior Vice President of Investor Relations and Corporate Communications

Thank you, and good afternoon, everyone, and welcome to Atea Pharmaceuticals' fourth quarter and full year 2021 financial results conference call. This afternoon, we issued a press release which outlines the topics 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.ateafarma.com. With me today from Atea are Chief Executive Officer and Founder, Dr. John-Pierre Sampiosi, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, Don Bevrica. They will all be available for the Q&A portion of today's call. Before we begin the call, as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. 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 John Pierre.

speaker
Dr. John-Pierre Sampiosi
Chief Executive Officer and Founder

Thank you, Joné. Good afternoon, everyone, and thank you for joining us today. I will begin on slide three. From the beginning, our goal has been to discover breakthrough drugs against severe RNA viral diseases. Today, with the evolving nature of COVID-19, it is clear that combination of direct acting antiviral will be needed to address this very challenging bowel disease. What have we learned in the past year? We are dealing with a bowel disease which is rapidly evolving from variant to variant within three to six months with major pandemic searches, such as what we have seen with Delta last summer and now with Omicron. We are also starting to see the significant public health and economic impact of long COVID which will continue to have long-term effect on individuals and society as well. This virus, which is constantly and rapidly mutating, is now evading vaccine and most of the monoclonal antibodies. And it's clear that we urgently need several oral therapeutics with different mechanism of actions to deal with challenging virus. while the protease inhibitor class has recently shown good efficacy against COVID-19. Historically, we have learned that this class of drugs has a low barrier to resistance with rapid development of resistance strains, especially in the immunosuppressed individuals, where we can see viral replication will continue for weeks and even months. Nucleotide drugs have been the backbone of successful oral combination regimens against many severe RNA viral diseases to mitigate this resistant issue and also to enhance efficacy. We believe that our nucleotide benifosbuvir, or AT527, has the potential to be a preferred nuke of choice for a combination regimen with a protease inhibitor for the treatment of COVID-19. Our team has experience in leading development efforts in several combination therapies for RNA viruses over the years, and we believe that we can deliver, again, a long-term solution with a combination of benifosavir and the protease inhibitor for the treatment of COVID-19 now. Turning to HCV, the recent in-licensing of ruzasvir combined with Benefos Revir will accelerate the timeline of our HCV program and may result in the best-in-class pangenotypic hepatitis C combination regimen. There is still a need for improved HCV treatment with shorter treatment duration, better convenience, and to eliminate revival in patients with advanced liver disease. As John will discuss later in the call, the hepatitis C market is large, and the global HCV market in 2021 approached $4 billion, with the U.S. still representing about 50% of the market. We are also advancing our third clinical program, AT752, a nucleotide analog generated from our Purine platform. Dengue fever is the most prevalent mosquito-borne viral disease with a large global disease burden and lack of antiviral treatments. We have successfully completed the Phase I study late last year, and 8752 will now progress to a Phase II clinical trial conducting in dengue-endemic countries, as well as a challenge study conducted in the U.S., Let's now review our strategy for COVID-19. Moving to slide five, our vision for Benifozivir is to be a nuke of choice, as I've said, for the combination treatment with a protease inhibitor for COVID-19. Benifozivir targets the viral RNA polymerase which, as you may know, is a highly conserved enzyme, critical to the viral replication and the transcription of this virus. Uniquely, Benifos-BV has a mechanism of action, or MOA, with dual targets. It is both a chain terminator without introducing any mutation or new mutation in the viral genome, especially in the spike protein, as has been shown with molnupiravir. It is also inhibiting the NIREN function, which is also a functional function of the RNA polymerase, and which is also critical to the viral replication. Thus, we believe that this MOA provides the potential to create a high barrier to resistance, as well as provide antiviral activity across any variants of concern. And details relating to this MOA were recently published in the peer-reviewed journal Nature Communication. So based on this unique MOA, we can anticipate that Benifosvibir will maintain its activity as this virus continues to evolve. In all clinical studies to date, Benifosvibir was shown to be generally safe and well-tolerated Of note, it is non-methogenic, with no reproductive toxicity, and is non-theratogenic. And it is the safety profile which believes that makes benifosbuvir uniquely well-suited, not only for combination treatment regimen in COVID-19, but also for HCV, which we'll review during this presentation. I will now end the call over to Janet.

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