Atea Pharmaceuticals, Inc.

Good afternoon, everyone, and welcome to the ITEA Pharmaceuticals 4th 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 Joneigh Barnes, Senior Vice President of Investor Relations and Corporate Communications at ITEA Pharmaceuticals. Ms. Barnes, please proceed.

Good afternoon, everyone, and welcome to Atea Pharmaceutical's fourth quarter and full year 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.ateafarma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. John Pierce Amadosi, Dr. Aran Shahorga, Chief Medical Officer, Chief Development Officer, Dr. Janet Hammonds, Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran, and our Chief Commercial Officer, John Babrita. 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.

Thank you, Jonette. Good afternoon, everyone, and thank you for joining us. I will begin on slide three. Looking back at our substantial progress throughout 2023, I'm proud of the strong operational execution we achieved across our antiviral programs. The 2023 highlights from our COVID-19 program include the ability to leverage global surges to meaningfully advance our Phase III, Sunrise III study. This was made possible by the expansion of the global footprint and the broadening of the eligibility criteria for high-risk patients. So far in 2024, we continue to observe encouraging enrollment trends for Sunrise Threat. Reflecting the continuing unmet medical need, we were granted fast-track designation by the FDA for the evaluation of Benifazovir for COVID-19. We have continued to demonstrate that Benifazovir remained fully active against all variants tested in vitro, including the newest sub-variants related to the O-micron. The profile for Benifazovir is supported by robust clinical data, including favorable efficacy and safety, with no drug-drug interaction. We believe that Benifazovir has the potential to address the key limitations of current COVID-19 oral therapies. For HCV, the 2023 highlights include achieving regulatory approvals of a short eight-week treatment for the global phase two trial of the combination of Benifazivir and Rizazivir for the treatment of HCV. The rapid enrollment of the leading cohort, which has led to exciting SVR results that we will review today. we demonstrated in vitro synergy of the combination of benifazovir and resizivir and the comparing potency profile against major HCV resistance mutations. We are now evaluating several fixed-dose combination tablets in preparation for the Phase III program and subsequent commercialization. And we presented and published preclinical and clinical data in support of this program. We believe Benifazivir in combination with Rizosvir can significantly improve upon the current standard of care by offering a differentiated, short eight weeks, protease inhibitor free treatment, which has been well tolerated and has limited potential for drug-drug interactions. Moving to slide four. ATEA vision is focused on the discovery and development of antiviral drugs for the treatment and cure of serious viral diseases where there is a significant unmet medical need and where we can make a huge difference. As you know, we believe that COVID is here to stay. And the recent winter surge reminds us that new dominant variants like GN1 are striving despite the latest vaccine booster and treatments. The SARS-CoV-2 virus is accumulating mutations with amino acid substitutions faster than any other endemic RNA virus, highlighting the desperate need for a broader and more diversified arsenal of safe, well-tolerated, and easy to prescribe oral antiviral therapeutics. Our team continues to efficiently execute our global phase three trial, and I'm very pleased to announce today that we have achieved another significant clinical milestone and surpassed enrollment of 1,400 patients, triggering our second interim analysis in the supportive care monotherapy cohort. This is an important milestone. allowing for the data review by the independent DSMB for safety and fertility. For Sunrise 3, we anticipate several upcoming events, including the first interim analysis in March, the second interim analysis in the second quarter of 2024, and top line results during the second half of 2024. Benifaz maybe has the potential to address many of the key limitations of curing COVID-19 therapies, including safety, durability, and drug-drug interactions. Our goal is to deliver best-in-class treatment to the millions of patients for whom the current center of care is suboptimal or unsuitable. As part of a multi-pronged approach against COVID-19, We continue to also make progress with our discovery program focused on a highly differentiated second-generation protease inhibitor, and we expect to provide an update mid-year. For our Phase II HCV program, as stated earlier, we share new results with confirmed and 98% SVR4 post-treatment in the leading cohort of our Phase II combination. eight-week study. I will review these results in more detail. Our goal for this program is to substantially enhance the current set of care by offering a short eight-week protease inhibitor-free treatment that is well tolerated with low potential risk for drug-drug interaction for all HCV patients. Importantly, We are in a strong financial position to execute our strategy with $578.1 million of cash and cash equivalents as of December 31st, with a runway anticipated through 2026. Andrea will provide a detailed update on Atea's financial position during today's call. I will now turn the call over to Arentza for an update on our HCV program.