8/8/2023

speaker
Operator
Conference Call Operator

Gentlemen, welcome to the ATIA Pharmaceuticals second 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 up for your questions. I would now like to turn the call over to Janae Barnes, Senior Vice President of Investor Relations and Corporate Communications at ATIA Pharmaceuticals. Ms. Barnes, please proceed.

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

Thank you, Operator. Good afternoon, everyone, and welcome to ATEA Pharmaceuticals' second 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 from IPEA are our Chief Executive Officer and Founder, Dr. John Pierre Sommadosi, Chief Development Officer, Dr. Janet Hammond, Dr. Arantja Horga, Chief Medical Officer, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Bavrica. 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 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.

speaker
Dr. John Pierre Sommadosi
Chief Executive Officer and Founder

Thank you, Joné. Good afternoon, everyone, and thank you for joining us. I will begin on slide three. During the first half of the year, we have made considerable progress across our COVID-19 and HCV programs. For COVID-19 program, fast-track designation for the development of Benifazovir was granted by the FDA in the second quarter and reflects the continuing unmet medical need that remains for COVID-19 patients. including multiple data presentation during the first half of the year, support the favorable efficacy, safety, and lack of drug interaction profile of Benifazovir. We believe that Benifazovir has the potential to address the key limitations of current COVID-19 therapies. With the protocol amendment modification that Janet will review today for our Phase III, Sunrise III trial, We have adapted our protocol to reflect the current status of the pandemic while still remaining on track with our upcoming near-term milestones, which include an interim analysis around the end of the year and top-line results from the study anticipated mid-2024. We continue to target an NDA submission by year-end 2024. As part of a multi-pronged approach against COVID-19, we are advancing a discovery program focused on the second-generation protease inhibitor that is highly differentiated and has a clinical profile quite unique and well-suited for combination with benifrost reveal. We are continuing to make progress with this program, and we expect to provide an update around the end of the year. for our HCV program, I'm pleased to report that in June, we began dosing patients in our phase two study, evaluating the combination of venifosavir and rosavir. This was a significant milestone for ATER, and we continue to expect initial results from the leading cohort of approximately 60 patients around the end of the year. Data presented earlier this year at the International Conference on Antiviral Research support the profile of our HCV combination with in vitro data consistent with a highly competitive profile compared to the current standard of care. Importantly, we are well capitalized and in a strong position to execute on our mission with more than $600 million of cash and cash equivalent and Andrea will go over the details with you. I will now turn the call over to Janet for an update on our COVID-19 program.

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