Mesoblast Limited (NASDAQ:MESO) Q1 2023 Earnings Call Transcript

Edward Tenthoff : And how long that will take weeks or something like that pretty short term.

Dr. Silviu Itescu: Very short term.

Edward Tenthoff: Okay. Excellent. Just with respect to launching the lower back pain study. What are plans to advance that into Phase III? And kind of, I guess, similar question for heart failure. Is the goal still to partner heart failure and develop quite a lower back pain on your own? Or what’s the kind of latest on that.

Dr. Silviu Itescu: So I’ll take — I’ll give the question on heart failure, and then I’ll have — I’ll ask Eric Rose to talk about the back pain program. So with respect to the heart failure, you’re quite correct. As soon as we’ve had our meetings with the FDA and pathways clarified. We intend to work with partners to complete the commercialization of the heart failure program. Eric, do you want to talk about our plans for confirmatory Phase III trial in back pain?

Edward Tenthoff : Silviu. Sorry to interrupt, Eric, sorry to interrupt before you start on lower back pain. But Silviu, have the FDA meetings regarding FRAP in scheduled phase.

Dr. Silviu Itescu: We’re waiting for specific dates.

Edward Tenthoff: Got you. And Eric? Yes, go ahead, sorry.

Dr. Eric Rose: With regard to back pain, our expectation is to do two trials, which we will begin — we hope in the second quarter, the third quarter of ’23. We’re finalizing that trial design with pain as the primary endpoint at a year. As a secondary, we’ll be using a scale and quality of life, but it will not be a co-primary. It will be secondary endpoint. We believe that we will show a quality of life benefit using this scale as well. It’s a scale which we have familiarity with, and we expect to finalize the design with the agency in the next few weeks, actually. So the final trial design will be submitted to them in accordance with the discussion that we had on what it should be in the past. But again, with that, we expect to start that trial in the second quarter of 2023.

Dr. Silviu Itescu: I might — Ted, I might add. So the U.S. trial will start rapidly. A second trial is likely to be a European-focused study so that we can get potentially in front of both FDA and EMA concurrently.

Operator: And with that, that brings us to the end of today’s call. I’d now like to turn the floor back over to Dr. Itescu for closing remarks.

Dr. Silviu Itescu: Great. Again, thank you to everybody for joining us this morning. We’re extremely excited by the long-term survival data, which really are unparalleled, and we’ll have a lot more to say at our upcoming AGM. Thank you very much.