Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals' Fourth Quarter and Full Year 2022 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. [Operator Instructions] Please be advised that today’s conference is being recorded. I’d now like to turn the call over to Jonae 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' fourth quarter and full year 2022 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 Investors section of our website at ir.ataepharma.com. With me today from Atea are Chief Executive Officer and Founder; Dr. Jean-Pierre Sommadossi; Chief Development Officer; Dr. Janet Hammond; Chief Medical Officer, Dr. Arantxa Horga, Financial Officer and Executive Vice President of Legal, Andrea Corcoran; and our Chief Commercial Officer, John Vavricka. They will all be available for the Q&A portion of today's call. Before we begin the call, outlined on slide 2, I would like to remind you that today's discussion will contain forward-looking statements that involve risks 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.

Good afternoon, everyone. And thank you for joining us, as you will see on slide 3. this year, we are poised to continue the meaningful progress made across our advanced clinical development programs following strong execution in 2022. Clinical efficacy results from the MORNINGSKY trial informed now of Phase 3 SUNRISE-3 trial of Bemnifosbuvir for the treatment of COVID-19, which was initiated in the first quarter of 2022. We anticipate an interim analysis from the SUNRISE-3 trial in the second half of this year, followed by completion of enrollment by year end. We also made meaningful progress, advancing our preclinical second generation protease inhibitor program, and we anticipate filing an IND for clinical candidates around the end of the year. With our HCV program, we completed preclinical and manufacturing work needed for the initiation of a Phase 2 combination trial of Bemnifosbuvir and Ruzasvir in the second quarter. With our Dengue program, we conduct the two proof-of-concept studies for AT-752 and the results will be shared with you today. Let's now move to COVID-19. Turning to slide 5, Bemnifosbuvir is on all nucleotides pro drug, the target viral RNA polymerase, a highly conserved enzyme critical to viral replication and transcription. We believe that Bemnifosbuvir profile addresses the key limitations of current therapies. It has low risk of drug-drug interactions, and maybe co-administered with commonly prescribed drugs for high risk COVID-19 patients, a key limitation of Paxlovid. Scientific presentation demonstrating Bemnifosbuvir lack of drug-drug interactions were presented last week at the Conference on Retroviruses and Opportunistic Infections, also called CROI. The US COVID-19 Public Health Emergency is set to expire on May 11. And the market dynamics with COVID continue to show. Based on the [inaudible] there are very limited treatment tools available, which essentially only packs lobbied for our patients…

Thank you, Sommadossi. As Jonae mentioned in her introductory remarks earlier today, we issued a press release containing our financial results for the fourth quarter and full year 2022. Those statements of operations and balance sheet can be found on slides 22 and 23. Our balance sheet remains strong with cash, cash equivalents and marketable securities of $646.7 million at December 31, ‘22, compared to $764.4 million at December 31, ‘21. R&D expenses were $27.5 million and $81.9 million for the fourth quarter and full year 2022 respectively, compared to $57.8 million and $167.2 million for the corresponding period in 2021. The decrease in R&D expense was primarily due to the elimination of the cost share arrangement with Roche. In addition, in Q4, ‘21, we recorded a $25 million expense due to the upfront payment related to our in license of Ruzasvir from Merck. G&A expenses remained relatively consistent at $12.4 million and $48.7 million for the fourth quarter and full year 2022 compared to $13.2 million and $45.8 million for the corresponding period in 2021. Interest income and other was $5.6 million and $11.2 million for the fourth quarter and full year 2022 compared to less than $0.1 million and $0.2 million for the same period in 2021. The increase was primarily the result of investing in higher yields marketable securities, and higher interest rates. For 2023, our R&D spend will be driven principally by spending on clinical trials, including primarily our SUNRISE-3 Phase 3 clinical trials for COVID-19 and our hepatitis C Phase 2 study at the combination of Bemnifosbuvir and Ruzasvir. In enclosing, due to the de-prioritization of our program for dengue, we are extending our cash guidance into 2026. I'll now turn the call back over to Sommadossi for closing remarks.

Thank you, Andrea. In closing on slide 25, we have a busy year ahead of us as we continue to advance our antiviral programs to fight serious viral diseases, especially for patients with limited treatment options. Importantly, we are well capitalized to fund our program through key inflection points and beyond to the finish line with an extended cash runway now until 2026 due to de- privatization of our Dengue program. With that, operator, we will now open the call up to your questions.

[Operator Instructions] Our first question comes from Matthew Harrison of Morgan Stanley.

Hi, this is Deep for Matthew. Thanks for taking my question. So I want to ask would you consider to license out your Dengue program since you deprioritize this one? Thanks.

I'm sorry, can you repeat the question?

Oh, sure. Would you consider to license out your dengue program?

Well, look, as you know, there is some nonprofit agency and government agency and other sub parties as well that have the potential to be interested in the collaboration partnership. We are not giving our guidance on and one if this could happen, but certainly we are interested in discussing with third parties

Our next question comes from Tim Lugo of William Blair.

Hi, this is John on for Tim. Thanks so much for taking our questions. So maybe two from us. So I'm wondering if you could maybe just give us some color commentary on your confidence in enrollment of the SUNRISE study? I mean, obviously, we're seeing a lot more apathy towards COVID and we are seeing less reporting that's going on. Seeming to show that seems like trends are going in our favor. But it's sometimes it's a little hard to tell with the lower reporting. So you could just tell us something about what you're seeing coming through, especially in the higher risk populations.

Yes, Janet?

Thank you, John. Yes, enrollment is continuing in SUNRISE. And we're making good progress, we filed a clinical trial in all targeted countries for regulatory approval. And we are continuing to see enrollment, but we're not going to provide specific numbers at this point. And but we will continue to report as the year goes through.

Maybe just one more from us. So I'm seeing some articles now coming out that viral rebound is more common than we initially might have thought, regardless of treatment with an antiviral, such as Paxlovid. Wondering if you maybe have any updated thoughts about this, or the time course is just too short? Is this maybe fixed with a combination? And maybe how you're thinking about this longer term?

Janet, you want to address the question?

Yes, thank you. Yes. We've been watching the reports also with some interest and there seems to be a variety of theories, I think so really, you'd have to call in as to what the cause for viral rebound, maybe. And it's something that we're certainly watching in our study, we're going to be collecting biological samples, and also continuing to watch patients for symptoms of rebound, as well as just plain viral rebound as we conducted a study. And so we hope to get some further clarity and information on that. But I think the jury's probably still out as to exactly what happens here. Whether it's very specific, whether it's dependent on viral load and a much higher viral load, and perhaps needing longer times to care. It's still something I don't think we fully understand. But thank you for the question.

If I may just add, it sounds like you have some post hoc analysis on some trial. There was rebound, highly depended on the age of the patients. And so we hope that the with our high risk patient population, actually, mostly in the elderly, we're going to really evaluate, as Janet indicated, those potential rebounds and the impact of the combination.

This question comes from Roanna Ruiz of SVB Securities.

Great. Thanks, and afternoon, everyone. Appreciate you walking us through the Dengue results. So I'll start there. I was curious if you could clarify which factors seem to contribute the most to the unavailable results for DEFEND-2 sourcing different things like it may possibly trial execution, maybe there were some placebo arm trends that were difficult to interpret. And were you able to garner anything about the possible the potency of 752 in this trial.

I'm going to let the Arantxa but in terms of potency as I have indicated, I'm going to let Arantxa that, let's not forget that fever is the major clinical sign of dengue. So Arantxa why don't you address the question, please?

Yes, thank you. Thank you for the question. So -- might contributed through the viral [inaudible] unavailable. I think the main reason is that the patients tend to come later in the course of the disease. And as you can see in the slide a lot of them particularly in the placebo have already either low or undetectable viral by the time, they come to you and they come to you later. It's not unusual. We mandate 40 hours fever criteria but patients sometimes have a hard time identifying really when the fever started exactly. And so they probably came later, presented later by the time we were able to enroll them. Another factor is that the test that we use for enrollment NS1 antigen is an antigen test. And as you seen with COVID antigen tests are not often very sensitive. They're not as sensitive as PCR but sites don't have PCRs available. So we will need to develop better more sensitive diagnostic tests if we want to advance programs like this. So those are contributing factors. And with regards to the efficacy question, I think what we have seen in this data is a resolution of fever that is factoring more rapidly active and as you know fever is being clinical sign for dengue. In fact, it's called dengue fever. And so we think that the resolution, faster resolution of fever, even considering such a small data set, is quite interesting and promising a signal in this trial.

Got it. Thanks for clarifying. And another question on the COVID program. So could you remind us, what do you want to see in the SUNRISE-3 interim to encourage you to move forward and if we fast forward and get positive final results, do you still think EUA is on the table with the FDA?

Janet?

So we're planning to do an interim analysis when we achieve enrollment of 60% of the patient population in the study. And as you know, the primary endpoint is proportion of patients who require hospitalization. So we're looking to see something to suggest that we're going to an overall hospitalization rate in the patient population of ideally 4% to 6% is what we're anticipating. And we still think that actually in the patient population that we're going after in the study, that this is not an unreasonable number. And there have actually been some recent articles coming out, I think, in support of that. So that's where we plan to be there.

This question comes from the line of Umer Raffat of Evercore ISI.

Hi. This is Jessica Hui on for Umar. Just one question. We're trying to reconcile the SUNRISE-3 study design with that of a competitor oral COVID antiviral especially in light of the announcement last month that the COVID public health emergency will end in May. Specifically, the FDA took issue with a placebo controlled study in the US. So I just want to confirm that in the SUNRISE-3, the randomized monotherapy population will still include US patients. And you don't expect the FDA to want you to change your trial design?

The short answer is no. But Janet wanted to expand on my answer.

Sure. Yes, the answer is no. The FDA has endorsed and reviewed our Phase 3clinical trial. And I think, as we described, patients are being randomized to drug or placebo on top of what is the available standard of care for the patient where they are. And actually, I think, as Jean Sommadossi mentioned in his remarks, there actually are significant number of people, and actually, particularly unfortunately, in the most vulnerable patient population, people who are unable to take Paxlovid because of drug interactions. And so for patients such as these, our drug is administered on standard of care, which would not include a direct acting antiviral. We do allow patients to have access to direct acting antivirals monoclonal antibodies if those were to be considered to be effective. And patients are allowed to be vaccinated also. But many patients, we believe, will actually not be taking anything other than our drug or placebo because of these circumstances.

We have another question from Roanna Ruiz of SVB Securities.

Hey, thanks for taking that extra question. I just want to circle back about the possibility of an EUA for Bemnifosbuvir. Do you have any updated thoughts on that?

Janet?

I'm so sorry. I realized as soon as I finished that I hadn't gone to your question completely. Yes. So we believe that an emergency use authorization is still possible. I think it's at the discretion of the Health and Human Services to allow four EUAs even with the passing or the lapsing of the pandemic health emergency. So we believe it will be data driven and depending on what we see as to whether such a thing might be possible. But we believe it is still possible, should we have good results, even at the interim analysis.

Thank you. That concludes our Q&A segment. I'll now turn it back over to Atea Pharmaceuticals team for any closing remarks.

Again, thank you all for joining us today.

And thank you for your participation in today's conference. This does conclude the program. You may now disconnect.