Release Date: May 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Atea Pharmaceuticals Inc (AVIR, Financial) has successfully completed enrollment for the SUNRISE three global Phase three trial for COVID-19 ahead of schedule, demonstrating strong operational execution.
- The company reported a robust financial position with $541.5 million in cash, cash equivalents, and marketable securities as of March 31, 2024, extending their financial runway into 2027.
- Atea Pharmaceuticals Inc (AVIR) showcased promising clinical progress in their HCV program, with a 98% SVR4 rate from the lead-in cohort of 60 patients, indicating high efficacy of their treatment.
- The company is preparing to initiate a Phase three study for their HCV program by the end of the year, aiming to address unmet medical needs with a potent fixed-dose combination.
- Atea Pharmaceuticals Inc (AVIR) has a strong pipeline with potential blockbuster treatments for both COVID-19 and HCV, which could significantly impact the multi-billion dollar markets for these diseases.
Negative Points
- The increase in research and development expenses for the first quarter of 2024 compared to the same period in 2023, primarily due to higher external spend related to clinical trials.
- The company faces intense competition in the COVID-19 treatment market, with only two approved antiviral products but significant unmet needs due to drug-drug interactions and safety concerns.
- Challenges in the HCV treatment landscape, including the need for shorter treatment durations and fewer contraindications, which could impact the adoption of new therapies.
- Regulatory uncertainties and the need for extensive safety databases for registration, particularly concerning the combination antiviral treatments for HCV.
- Dependence on future government initiatives and removal of access barriers by payers to increase the number of patients treated for HCV in the U.S.
Q & A Highlights
Q: Hi there. It's Billy on for Eric. Thanks for taking our question. I know before you've mentioned about how in any HCV trial you've been enrolling cirrhotic patients. Just wondering, on a percentage basis, how sizable this would be of the 220 patients?
A: (Arantxa Horga, Chief Medical Officer) Yes. Well, you know, it depends on how many we enroll. We have targets in the protocol and our targets would be first of all, at least 10% between 10% and 20%. And it's a target we will, yes.
Q: Great. Thank you. And I was wondering if you would provide any thoughts on Shionogi's recent Phase three update, which they missed on the primary and their intention to meet the FDA also which secondary endpoints in SUNRISE three trial, would you call out as particularly important given the competitive landscape? Thank you very much.
A: (Janet Hammond, Chief Development Officer) Thank you. Yes, so with regard to the Shionogi Phase three trial. I think our inflammation is much the same as yours. I think to some extent, symptom endpoint has been a case which has not been successful for companies developing and trial drugs in this space. And so I think some of the things which are different from that trial than us were really, I think, first and foremost that they selected to go after this as the primary endpoint, I think they were amid pains to point out that they did succeed on a subset of this instance, however, and it's obviously disappointing to see them failing on the on that key primary endpoint. And we have, as I mentioned, an FX in hospitalization because we have strong proof of principle on that from our morning Chegg Study and our population is different from those that we enrolled exclusively high-risk patients. Class of utilization continues to be a problem. And however, I think that and obviously hospitalization hasn't been as common as it was previously should also good. And so I think in regard to secondary endpoints, we have endpoints which are comparable to what others have in terms of looking for reductions in viral load in patients looking also for substantial evidence of viral rebound. And this is something which has been described, I think and both in placebo and increased patients. And we have a commitment to look at that also looking for evidence of emergence of resistance and also looking for hospitalizations and medically attended visits all the way to day 62. I think those are the key end points of Maxygen.
Q: Hi, guys, it's John on for Omar. I would like to start with the expectation is to do two Phase threes internally. So does your current run rate guidance to 27 include two Phase threes for HCV? And then secondly, obviously, you need to have that meeting with the FDA, but do you have a sense of what the time line for the registrational program could be if your assumptions of a trial design are all are all true? And how long do you think these trials would take to run. And then just lastly on the Easel data that was coming up later this month, and we are going to include new data on the lead-in cohort is that going to include long term SVR legacy R 12 for that lead-in cohort or or just a fuller details of SEF?
A: (Jean-Pierre Sommadossi, Chairman of the Board, President, CEO, Founder) And thank you, John. Just to address your second part of the question, we were presenting new Phase two efficacy data. As you know, the embargo for abstracts lifted on May 22nd, and we would be excited to present the data on June fifth, we cannot say more than that, not to break the the embargo on the Easel. Andrea, can you go over into some of the finance or the budget in terms of what we include on to go all the way to 2027. And I would first overall, the regulatory part, Louis, Andre? (Andrea Corcoran, CFO) Yes. Yes, John. So in answer to your question. Our guidance does anticipate that we will have a two phase three trials and they will be completed during that window of time with our existing resources. (Jean-Pierre Sommadossi) And regarding time lines, whether so it completes the end of the Phase two and the agreement with the regulators, obviously first in the US and in Europe. But this would be global trials and we have to do with several regulators. So I think we will have a better view in 2025 and share what we see as the time lines are, John.
Q: Thanks for taking my question. And I know you mentioned you don't want to break the Easel embargo. Can you discuss the kind of what broadly the fixed dose combo HDV looks like I know, Ben, the thoughts there being dosed at five 50 megs once a day and risa is one 81 today is the case, does roughly a combination of what the convert and look like and Dan and I are so yes, and to start that, so look on we would it would be a tablet and we don't want to have a huge tablet, the 1.21 0.3 gram.
A: (Jean-Pierre Sommadossi, Chairman of the Board, President, CEO, Founder) So we believe that tablets will be the or the ideal a formulation once-a-day, obviously. And again, we are we have several formulations. We have excellent data in dogs under several conditions are we have completed already one fixed dose combination. We anticipate to have one or two more actually and the next one will start in the next couple of weeks. So as you can see, we want to maximize our goal is to get very close to 100% drug exposure for both of them. And with us, we are without any food effect, basically, that's our goal, Jim.
Q: Hi, everyone. This is rose on for on a release. A couple of questions on HDD., can you have a sense for how large of a safety database you'll need for registration and thinking about the decompensated cirrhosis patients that was mentioned, can you give us a sense of the percentage of these patients and as they make up like the total HDD population.
A: (Arantxa Horga, Chief Medical Officer) So regarding the safety database for a combination antiviral like this, usually, it's around 5,000 patients at the recommended dose. And length of treatment. And so that's roughly what the Phase three program we have to have plus what we are already involved in on in Phase two. And the second question was the percentage of decompensated patients. I cannot give you the exact percentage in the United States, but it's really less and less and it's really quite feel there is some still in usually Asia, some Asian
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
