Atea Pharmaceuticals, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Sure. Good morning, Jean-Pierre, founder, Chairman, and CEO.

Hello, everyone. Janet Hammond, I'm Chief Development Officer.

I'm John Vavricka, head of commercial operations.

I am Arantxa Horga, I'm the Chief Medical Officer.

First, I would like to thank Morgan Stanley for the kind invitation. I appreciate the opportunity to give an update today of our programs. As you know, we recently disclosed a successful first phase III trial for our treatment against hepatitis C, with achieving the FDA-agreed primary endpoint on our SVR12. We are, obviously, very excited to have a non-inferiority statistical significance with the current standard of care with EPCLUSA. We believe that we have a best-in-class regimen with a short duration. What's important, obviously, in that phase III, which was performed in North America, predominantly in the U.S., and let's not forget that we were comparing an 8-week treatment against a 12-week treatment for EPCLUSA in non-cirrhotic patients, which represent about 90% of the patients in the U.S. We performed very well from an efficacy and safety standpoint.

We look forward to have our ex-U.S. trial, C-FORWARD, releasing data very early in Q1 next year. We are fully enrolled. Almost all patients actually have achieved now week 12, which is when they have completed the full treatment. This second trial will allow us to support the first trial, but also to expand the robustness of the number of patients with genotype 1c, mostly in Western Europe, genotypes 3, 4, 5, and 6, which are the rare genotype. A label is essential today, as no one is doing genotyping before treatment. We have also a second program where we are very excited with hepatitis C. We are in the process to complete the single ascending dose. We like the PK. We see the drug exposure and the safety so far.

We will complete the multiple ascending dose for the end of the year, and we will be in the proof of concept next year for hepatitis C. Next year will be a very important year because that will be when we anticipate in Q2, very likely June, the filing of our regimen for hepatitis C with the FDA. Again, thank you for allowing us to share those updates. The team, Janet, John, and Arantxa can go in details on the questions.

Arantxa? The C-BEYOND trial, our U.S. trial, we recently have data released from it, and we were very excited to see very robust efficacy with rates in 94%, 95% with only an 8-week regimen as compared to the standard of care, which was a 12-week regimen.

This is with the attributes of what people are expecting today in the hepatitis C landscape. That's a short treatment duration, low probability of drug interactions, no full effect, and we saw a good tolerability profile. That's what people are looking for today. In terms of C-FORWARD, Max, the trial is very well positioned to be a confirmatory trial of what we saw in C-BEYOND. It's a trial that, as JP said, is running ex-U.S. in multiple countries, over 17 countries, and it has a broad global population and also viral genetic diversity with different genotypes, as JP mentioned.

We think that that is going to be a confirmatory trial that is very likely to reproduce the excellent results that we saw in C-BEYOND for two reasons. One is the trial design is closely aligned to C-BEYOND, so basically, they have the same primary endpoint. They have a very aligned statistical analysis plan, the same power assumptions. This makes it very likely to reproduce what we saw in C-BEYOND. Also, the strength of C-FORWARD is that we are going to be seeing the primary endpoint in two populations, like we see in C-BEYOND, in the population, which is the MITT population, so that's everybody that received one dose, and that's the FDA preference, and we met the primary endpoint there.

But also in the per-protocol population, which is the population that is a subset, that is the population that adheres to the regimen and to the protocol, and that was the preference of the EMA. We think that in that way, because we met both in C-BEYOND, we have a lot of confidence that we're going to be seeing the same results in C-FORWARD.