Atea Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceutical second quarter 2022 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. In order to ask a question, you'll need to press star 1 1 on your telephone, and you'll then hear an automated message advising that your hand is raised. Please note that today's conference is being recorded. I would now like to turn the call over to Janae Barnes, Senior Vice President of Investor Relations and Corporate Communications at Attea Pharmaceuticals. Please proceed.

Good afternoon, everyone, and welcome to Attea Pharmaceuticals' second quarter 2022 financial results conference call. Earlier today, we issued a press release that 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 irateafarma.com and go to the events and presentation section. With me today from Atea are Chief Executive Officer and Founder, Dr. John Pierre Semedosi, Chief Development Officer, Dr. Janet Hammond, Chief Financial Officer and Executive Vice President of Legal, Andrea Corker, 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 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 from what is discussed on today's call. With that, I'll now turn the call over to Jean-Pierre.

Thank you, Julie. Good afternoon, everyone, and thank you for joining us today. I would like to start with our many thoughts of your program, where there is much to report, as you can see summarized on slide three. It is now evident that, as detailed on slide four, COVID-19 will likely remain a global health concern for a very long time. We see new variants and sub-variants emerging in shorter time intervals, and the rate of infection is increasing. The changing characteristics have caused the existing antibody treatment to fail and have reduced the efficacy of vaccine-induced immunity, creating the need for frequent and early engineered booster to combat the emerging variants. Pandemic surges can be life-threatening, to those at high risk over 65 years old, particularly those with risk factors causing increased hospitalization and death. Right now, BA.5 accounts for the vast majority of infections. It's highly infectious, and new variants are expected to fuel a surge of this fall. New oral antivirals with improved profiles are urgently needed. due to the limitations of the current antiviral treatment options. These limitations include the issue of relapse, which was experienced by both President Biden and Tony Fauci, among others, after taking Paxlovid. Relapse can lead to a rebound of symptom as well as transmission of infection to others. Other limitations include drug-drug interactions with many commonly prescribed life-saving drugs. These drugs are frequently used among those that are the most vulnerable to COVID-19, limiting the ability for Paxlovid to be prescribed and raising treatment dilemma for patients and prescribers. With very fast review, we have the potential to address many of these limitations, and we are working diligently to deliver improvements over the current standard of care. Moving to slide five, We recently had an end-of-phase two meeting with the FDA and met with the European Medicines Agency Emerging Task Force to review the Benefos Reveal data package today, including the Morning Sky results. Let me remind you that in the Morning Sky study, which we reported in May, the risk of hospitalization was 71% lower in the Benefos Reveal 550 mg BID arm versus placebo with a p-value equal to 0.047, unadjusted and exploratory. Obviously, we are very encouraged with this outcome, and the results were consistent in both standard and high-risk patients as well. We are now in the process of finalizing the design of a global late-stage clinical trial for the treatment of mild to moderate COVID-19. The trial will evaluate many parts of you, 750 milligrams, those twice daily for five days in high-risk patients, including those who are immunocompromised, regardless of vaccination status. The primary endpoint will be hospitalization and death. Operational planning is currently underway for this global trial. and we expect to initiate this study in the fourth quarter of this year. Turning to slide six, we are confident that very fast review will remain fully active against future variants. This is based on the consistent potent antiviral activity that we continue to generate as new variants of concerns emerge and are tested. Our most recent data set confirms antiviral activity against omicron surveillance similar to the potency demonstrated with alpha, beta, gamma, epsilon, and delta. This data reinforce our understanding of venifos will be a potent inhibition of the two functional domains of the highly conserved viral RNA polymerase. Let me remind you that details related to the molecular mechanism were published in natural communications earlier this year. Moving to slide seven, based on the evolving nature of COVID-19 variants and unmet medical needs, we are pursuing a multi-pronged approach which places us at the forefront of developing a combination regimen to fill the treatment gaps of COVID-19. In the future, we see a role for benifosovir as monotherapy, as well as in combination regimens. Right now, as previously noted, there are treatment gaps with first-generation protease inhibitors, including drug-drug interactions and relapse homo-odosens. Also, we can anticipate resistance to emerge with broad use, prolonged treatment, and retreatment when protease-administered when protease inhibitors are administered as monotherapy. With very positively attractive profile, we believe that he has the potential to become the cornerstone therapeutic for both monotherapy and incombination therapy. This is our rationale for pursuing in parallel to our late-stage monotherapy trial a second-generation protease inhibitor with an improved profile to be used in combination with venifosbuvir in specific patient population. On slide eight, as part of this approach, our target profile for second-generation protease inhibitors is a highly potent drug that has a good safety profile with limited drug-drug interaction and does not require ritronavir or any other booster. And I'm pleased to report today that we have made significant progress with our internal program. Indeed, in a short time period, we have achieved two essential properties with potency at nanomolar and sub-nanomolar levels and good metabolic stability, leading to highly promising compounds. We are now working to combine this potency and metabolic stability in the clinical candidate, which we hope to select later this year. Moving to slide nine, the antiviral effect of benifazovir, in combination with the protease inhibitor Paxlovid, was examined in vitro in an HCAR229E cell good model. And the results indicate an additive antiviral effect. So not only we are encouraged by this data, but also this data supports potential benefit of a combination of benifrogravir with a protease inhibitor for the treatment of COVID-19. I will turn the call over to Janet for a review of our dengue fever and hepatitis C programs. Janet?