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5/8/2023
Good afternoon, ladies and gentlemen. Welcome to the ATEA Pharmaceuticals First Quarter 2023 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call for your questions. I would now like to turn the call over to Joneigh Barnes, Senior Vice President of Investor Relations and Corporate Communications at ATEA Pharmaceuticals. Ms. Barnes, please proceed.
Thank you, Operator. Good afternoon, everyone, and welcome to Atea Pharmaceuticals' first quarter 2023 financial results and business update conference call. Earlier today, 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.ateapharma.com. With me today from Atea are Chief Executive Officer and Founder, Dr. Jean-Pierre Samadosi, Chief Development Officer, Dr. Janet Hammond, Chief Medical Officer, Dr. Arantja Horka, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Beverica. They will all be available for the Q&A portion of today's call. Before we begin the call, and as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risk 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 Jean-Pierre.
Thank you, Jolene. Good afternoon, everyone, and thank you for joining us. As you will see on slide three, we have had a busy start of the year with progress across our COVID-19 and HCV program. I will begin with a few highlights from our COVID-19 program. First, we remain laser focused on the execution on our global Sunrise 3 study, where I am pleased to report that as of today, we have a broad geographic footprint with regulatory approvals in over 50% of the targeted countries. Just last month, we were excited to receive from the US FDA a fast-track designation for Benifazivir for treatment of COVID-19, which has the potential to expedite the development of Benifazivir. We presented multiple data sets at scientific meetings, including CROI, ICRAR, and ECMID, each of which highlighted Benifazivir clinical efficacy and favorable safety profile, including a compelling drug interaction profile. Finally, We continue to make progress advancing our second generation protease inhibitor. Turning to HCV, we remain on target for the first patient to be dosed in our phase two combination trial this quarter, and we continue to expect initial results from our first cohort of 60 patients by year end. Data recently presented at ICAR support our combination profile and new individual results indicate a highly compelling antiviral profile compared to the current standard of care. Moving to slide four, as I mentioned, we had a large presence at the major antiviral medical meetings during the first quarter. Some of the key highlights of our COVID program include the full results in the Morning Sky trial, representing showing a 71% reduction in risk of hospitalization, with benifazovir as compared to placebo in the morning sky trial with a subset showing 82% reduction in risk in patients over 40 years old. Low risk of drug-drug interaction with commonly prescribed medicine for COVID-19 and HCV, which we believe is a key feature of the drug. Slide five outlines the data presented at medical meetings beyond our COVID-19 program. At IFAR, we presented HCV combination data showing that benifosavir and rizosvir are potent in vitro synergistic antiviral activity and in vivo preclinical safety without adverse interactions. In addition, we presented data at ECMAT 2023 on the AT752 for dengue. Well, as you know, we deprioritized our dengue program and the development of AT752 in February 2023, we are exploring opportunistic ways to continue to move this program forward. Moving now to slide six. AD511, the freebase of benifosbuvir, has been shown to be a potent inhibitor of SARS-CoV-2 in vitro. New results demonstrated that AD511 also has potent antiviral activity against the SARS-CoV-2 or micron subvariant XBB. This is consistent with the previously demonstrated in vitro protein antiviral activity against other variants of concern and of interest, including alpha, beta, gamma, epsilon, delta, and various omicron subvariants, BA1, BA2, BA4, and BA5, and now the XBB. I will now turn the call over to Janet.
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