Moderna, Inc. (NASDAQ:MRNA) Q4 2022 Earnings Call Transcript

Now we’re not ready yet to guide on how quickly that will be, but we are fully aware of the fact that in fact, if there is a path forward for accelerated approval, the enrollment of that Phase 3 may be gaining, and therefore, we want to have it enrolled as quickly as possible. So at this point, we’ve just received the breakthrough designation, we’re engaging with regulators, and we’re going to try and develop that path forward. But it is theoretically possible that there is an accelerated approval path and that we would need to enroll that Phase 3 study based on recent regulatory guidance, more generally to the industry. And working hard to make sure that we can do that as fast as possible here, while continuing to conduct the additional interim analyses and see the maturity of this data continue to proceed, and hopefully, the strength of the benefit provided by the combination to be further validated.

Operator: Thank you. Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open.

Edward Tenthoff: Great. Thank you very much. And thanks for all the detail on the call today. My question, I had to go back to flu for a minute and just with respect to the follow-on candidates, including I think the one that’s pentavalent hemagglutinin and then fixed hemagglutinin and then also into the neuraminidase, the candidates at that neuraminidase, what should be our expectation both in times of timing for data here? And how do you ultimately see your seasonal flu product offering kind of evolving? Thanks.

Stephen Hoge: Thanks for the question, Ed. So let me start with the most advanced program, obviously, is our 1010 program, which we’ve talked about. And we have done an update to that vaccine that we think will increase the B immunogenicity for those populations for whom that matters, and we expect to advance that in clinical study quite quickly. That, in combination with the efficacy data that we were just talking about with P302, probably is the most important information for guiding our next step on the second-generation products. Our multiple €“ sorry, penta and hexavalent vaccines as well as the 1020, 1030 programs, which include neuraminidase, as you said, are all in various Phase 1 studies. And as we have shown repeatedly hopefully over the last couple of years, we can proceed very quickly in the subsequent Phase 3 in pivotal studies once we select one of those candidates to move forward.

But the really important gating information is understanding how is our first generation product performing in terms of efficacy as a first mRNA flu vaccine. And so we are waiting for that information before proceeding forward. But we do expect that at least one, if not multiple, of these second-generation products would move into subsequent pivotal studies, Phase 3 studies. And in those cases, because we would be looking to demonstrate some form of superiority either against a broader range of influenza strains or better protection against influenza-like illness because we have included additional antigens, we would expect those studies to include both immunogenicity and safety and efficacy end points as we move forward. And so we will make a selection on which ones we might move forward based on the ongoing interim analysis of efficacy from our 1010 program.

We don’t have another way to update at this point on which we will move forward.

Edward Tenthoff: Great. Thank you very much.

Operator: The next question comes from Michael Yee with Jefferies. Your line is open.