5/14/2024

speaker
Operator
Conference Call Operator

Good afternoon, everyone, and welcome to the ATA Pharmaceuticals First Quarter 2024 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 ATA Pharmaceuticals. Ms. Barnes, please proceed.

speaker
Janae Barnes
Senior Vice President, Investor Relations & Corporate Communications

Thank you, and good afternoon, everyone, and welcome to Atea Pharmaceutical's first quarter 2024 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 we'll be reviewing today, by going to the investor section of our website at ir.ateapharma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. John Pierce-Somedosi, Dr. Arantxa Horga, Chief Medical Officer, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, and our Chief Commercial Officer, John Veverica. 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 risk 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 Pierce-Somedosi
Chief Executive Officer and Founder

Thank you, Jolette. Good afternoon, everyone, and thank you for joining us. 2024 is off to a strong start with the tremendous clinical progress we have made across our program for COVID-19 and HCV. can see on slide three. I will begin first with an overview of our Benefits Review Program for the treatment of COVID-19. Trends observed in 2024 provide further evidence that COVID is endemic and is here to stay. Variants continue to evolve, and this winter we experienced a surge of infections caused by the variant GN1. Our strong operational execution led to the rapid and successful enrollment of the only global phase three trial exclusively conducted in high-risk patients ahead of our guidance. We randomized 2,221 patients into the supportive care monotherapy cohort and only 74 patients into the combination therapy cohort with 77% of total patients enrolled in the United States. Strikingly, the clear preference by the investigators to enroll high-risk patients in the monotherapy cohorts highlights the continuing unmet medical need for new oral COVID-19 treatment options for these high-risk patients. We believe that Benefosavir has the potential to address many of the key limitations or current COVID-19 therapies, including safety, durability, and drug-drug interaction. We look forward to potentially delivering benifosavir to millions of patients for whom the current standard of care is not an optimal option. We anticipate top-line results from Sunrise III in the second half of 2024. Turning now to our Phase II program for hepatitis C, Building up the positive 98% SVR4 rate from the lead-in cohort of 60 patients, we look forward to multiple key near-term milestones for this program. We are very excited about the upcoming presentation at EASL next month, which will showcase preclinical and new Phase II efficacy data from this lead-in cohort. We also look forward to reporting complete SVR12 results from this ongoing study during the second half of 2024. In addition, we are preparing for the initiation of a Phase III study, which we anticipate around the end of this year. We are currently finalizing the selection of the fixed-dose combination tablets, which will be used in the Phase III program as well as for commercialization. Benifazovir is the most potent nucleotide inhibitor for hepatitis C treatment, and Rizosvir is a highly potent NS5A inhibitor. We believe that the demonstrated synergistic effect of this combination can substantially improve upon the current standard of care for all patients infected with hepatitis C, including those who are the hardest to treat. and I will review our HCV program in greater detail next. Importantly, we are in a strong financial position to execute our strategy with $541.5 million of cash, cash equivalent, and marketable securities at March 31st, with our runway now anticipated into 2027. This is based on completing patient enrollment for Sunrise III ahead of schedule, and our ongoing financial discipline. Andrea will provide a detailed update on Atea's financial position during today's call. With that, I will now turn the call over to Ransom for an update on our global Phase II HCV program.

Disclaimer

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