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| Statement |
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| We demonstrated in vitro synergy of the combination of bemnifosbuvir and ruzasvir and the compelling potency profile against major HCV resistance mutations |
| In closing, following a year of solid operational execution across our two clinical programs, our clinical momentum sets us up to a transformational milestone-rich 2024 for both our COVID-19 and HCV program |
| Overall, we're seeing strong operational execution for SUNRISE-3 from our clinical team with robust enrollment trends |
| We believe that our product candidates are very differentiated and have the opportunity, if approved, to fill the gap in the current unmet medical needs and become blockbuster products |
| So far in 2024, we continue to observe encouraging enrollment trends for SUNRISE-3 |
| So, you can see that there is a huge opportunity for a best-in-class product, including even with the challenges that we face as Janet -- and Jessica, you recognize in terms of number of low event, but we believe that the way this study has been built will maximize the results for the efficacy and safety of this drug |
| In particular, we've experienced strong enrollment in the U.S |
| We believe that the compelling preclinical and clinical profile of bemnifosbuvir is differentiated with a low risk for drug-drug interactions, a favorable tolerability and a high barrier to resistance, and has the potential to become the treatment of choice for COVID-19 for millions of patients |
| In particular, I'm very proud of the team hard work throughout the year |
| Looking back at our substantial progress throughout 2023, I'm proud of the strong operational execution we achieved across our antiviral programs |
| Our team continues to efficiently execute our global Phase 3 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 |
| We are very excited about the opportunities ahead and are confident in our ability to develop and commercialize innovative products and create meaningful shareholder value |
| The combination of bemnifosbuvir and ruzasvir has the potential to substantially improve upon the current standard of care by offering a short eight-week protease inhibitor-free treatment with less side effects and a low risk for drug-drug interactions |
| The SARS-CoV-2 virus is accumulating mutations with amino acid substitutions faster than any other endemic RNA virus, highlighting the desperate need for broader and more diversified arsenal of safe, well-tolerated and easy-to-prescribe oral antiviral therapeutics |
| We have continued to target initiation of a Phase 3 around the end of the year, and we are extremely encouraged by the SVR4 and safety results in the leading cohort |
| So, I think these are the patient populations, which are probably the ones where there is likely to be the great benefit |
| Atea is a company with less than 80 employees, which is conducting two global studies in disease with multibillion-dollar market opportunities with a high degree of efficiency as well as with significant financial discipline |
| 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 31, with a runway anticipated to 2026 |
| The demand for oral antivirals in 2023 was very robust with a total of approximately 7.7 million scripts written |
| The 2023 highlights from our COVID-19 program include the ability to leverage global surges to meaningfully advance our Phase 3 SUNRISE-3 study |
| So, this is very important for the patients as the market research has indicated, but also when we talk to the KOLs on the field and when they were actually trying to redo our protocol and participate in our clinical trial, all of them were very excited that we could actually develop this best-in-class regimen, bringing the best of both -- attributes of both regimens |
| Supported by our extensive global footprint, we are seeing robust enrollment into SUNRISE-3 and patient enrollment has correlated with the latest winter wave |
| And so, I think being able to see how combination therapy and in particular, a protease inhibitor in combination with bemnifosbuvir is able to provide synergy and potentially reduce severity symptoms and allow patients to improve better |
| And also -- there's also other advantages such as having a no food effect and also to be able to treat with a shorter treatment duration, particularly important because, as Arantxa mentioned earlier in the presentation, what clinicians are finding is that the shorter time to treat is the better |
| The profile for bemnifosbuvir is supported by robust clinical data, including favorable efficacy and safety, with no drug-drug interaction |
| And the recent winter surge remind us that new dominant variants like JN.1 are thriving despite the latest vaccine booster and treatments |
| The rapid enrollment of the leading cohort, which has led to exciting SVR results that we will review today |
| Our goal is to deliver best-in-class treatment to the millions of patients for whom the current standard of care is suboptimal or unsuitable |
| It's like you said, a great unmet need population |
| Statement |
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| Despite current treatment options, HCV continues to be a health crisis in the U.S |
| And of course, hospitalization and death are the worst outcomes |
| COVID-19 continues to be an established pathogen of concern according to the World Health Organization |
| Now, let's not forget that this is patient population that is very difficult, very likely in a trial, you are going to have some deaths |
| And we believe that COVID-19 will remain an ongoing serious endemic issue |
| So, we're somewhat dependent on that, and we're going to have to see |
| despite availability of oral treatment |
| But as you know, the monoclonal antibodies haven't been able to keep pace with the evolution of the virus |
| I think in part, the compliance issues are just part of the nature of doing trials right now in hepatitis C |
| So, I think -- I mean, certainly, I mean, it's one of those things that is under consideration is if we're unable to do that, are there further avenues to pursue in terms of looking for trends |
| Janet Hammond No, I was just going to ask you if you wanted to follow on with Jessica's other question around the scenario where we fail to achieve the primary end point |
| We've seen a very strong winter season, but frequently, I think, at least in the past, we've observed that that's followed by some downward trend in the number of cases until we get towards the hotter summer months and people move indoors again |
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