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

Stephen Hoge: Thank you for those questions. So, on 4157, I think I will just reiterate our prior guidance, I don’t want to expand it, to say that we are trying to move into those pivotal studies, they are Phase 3 confirmatory studies for melanoma and non-small cell lung cancer, both adjuvant settings, this year. And we €“ you can look at the history of Merck and their ability to execute those studies, enroll quite quickly and now working together with us, we hope to be able to at least do that well. And we will look to enroll those at least as quickly as other confirmatory Phase 3 studies and similar populations have been run generally. But I don’t think we are going to provide more specific guidance on enrollment time horizon except to say we want to go as fast as possible.

I will also clarify, too that from an accelerated approval perspective, if that pathway were to become available based on the current Phase 2 data, which again is subject to future conversations with regulators, that we would want to have started those confirmatory studies. We wouldn’t have needed to complete enrollment, but definitely, we want to be demonstrating that we are moving forward in those confirmatory studies as quickly as possible. And so we have double impetus. We are moving fast in enrolling them in the near-term. Now, in the rare disease space, programs moving out of pre-clinical and clinical. The first I would say is we do have a clinical program for MMA, which you referenced, but that MMA program is another place where we expect to see additional data following on, hopefully, the continued strong performance of the propionic acidemia PA program.

And then in the pre-clinical development space, we have programs against OTC and PKU, so Phenylketonuria and a urea cycle disorder OTC, and those are both programs that we would hope to move into clinical testing in short order. We haven’t specifically guided on the timing of that yet.

Joseph Stringer: Many thanks for taking our questions.

Operator: Ladies and gentlemen, this does conclude the question-and-answer portion of today’s call. I would like to turn the call back over to Stephane for any closing remarks.

Stephane Bancel: Thank you very much everybody for joining us and for the many thoughtful questions. We look forward to hosting you for Vaccine Day on April 11. It will be live in Boston, for those of you who can join us, and also of course virtual. Have a great day. Thank you.

Operator: Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day.