Good morning, good afternoon to the operational highlights and financial results for the quarter ended September 30, 2022, as well as our upcoming Annual General Meeting. Apologies for the slight delay due to technical difficulties; beyond our control. Joining me here today is Dr. Eric Rose, our Chief Medical Officer; and Andrew Chaponnel, our Interim Chief Financial Officer. If we could go to the first slide. If we go to Slide No. 4, please. Survival outcomes have not improved over the past 2 decades, for children or adults with the most severe forms of steroid-refractory acute graft-versus-host disease. In particular, the lack of any approved treatment for children under 12 means that there's an urgent need for a therapy that improves the dismal survival outcomes in children. In light of the unmet need, remestemcel-L has been granted fast track designation and BLA priority review from the FDA. A major milestone in the company's complete response to the FDA was our submission at the end of the last quarter of substantial new information on clinical and potency assay items to the IND file for remestemcel in the treatment of children with steroid-refractory acute GVHD as has been guided by the FDA. Mesoblast has optimized the potency assay that was in place at the time of the Phase III trial and which demonstrates a relationship between the products activity in vitro and its effect on survival in the Phase III trial. Additionally, Mesoblast has now generated data from the expanded access program, EAP 275 in 241 children, which confirmed the ability of the in vitro potency assay to measure product activity relevant to survival outcomes. Next slide, please. Today, Mesoblast provided new results from a 4-year observational survival study performed by the Center for International Blood and Marrow Transplant Research, CIBMTR, on…

Thanks, Silviu. Now turning to Slide 8. We have the financial highlights for the quarter. As at September 30, 2022, cash on hand was $85 million, up to an additional $40 million may be drawn from existing financing facilities subject to certain milestones with current discussions to extend the period for the drawdown option. Net cash usage for operating activities in the quarter was $14.3 million. This represented a 22% reduction of $3.9 million on the comparative quarter in FY 2022, and a 47% reduction of $12.5 million on the comparative quarter in FY 2021. Revenue from royalty on sales of TEMCELL in Japan for the quarter were $1.4 million and $1.8 million on a constant currency basis. For the 12-month period ended September 30, 2022, royalties were $7.7 million, and on a constant currency basis $9 million, which was a 9% increase on the comparative period. Turning to the next slide, which is Slide 9, please. We can see the P&L results for the 3 months ended September 30. Within revenue, the majority of the change was due to one-off licensing milestone in the prior period and the impact of currency movements. There is a reduction in expenditure for R&D, manufacturing and management administration, totaling a decrease of 23% or $5.2 million for the period ended September 30, 2022, on the comparative quarter. During the quarter, we continued prelaunch manufacturing activities and product testing for remestemcel to support the potential commercial launch. On FDA approval, remestemcel inventory will be recognized on the balance sheet, currently valued at $28 million. Within finance costs, we include actual cash interest paid of $1.2 million for the quarter ended September 30, 2021, and also quarter ended 2022. The increase in our reported finance costs was primarily due to the recognition of a noncash gain on the revaluation of our borrowings in the comparative year. And turning to the last finance slide, Slide 10. This slide highlights our reduction in burden, which has reduced 33% or $30 million on a rolling 12-month basis. Now I'd like to turn the call back to Silviu.

Thank you, Andrew. If we can now go to Slide 12, which is our pipeline slide. And I'll focus on the updates to our product candidate remestemcel for acute graft versus host disease in children. This continues -- if we go to Slide 13, please. This continues to be a significant unmet need with high mortality in children under 12, there are no approved therapies. The disease burden remains very high, and mortality can be as high as 90% with significant extended hospital stay costs. Slide 14, please. Slide 14 summarizes the data that has been generated over a number of years with remestemcel on improvement in early survival in children with steroid-refractory graft-versus-host disease. The data highlighted on this slide come from 4 distinct studies, 27 children who are randomized in a controlled Phase III trial of 260 patients mostly adults with steroid-refractory graft-versus-host disease. A second study of in a Phase III trial of 54 children, open-label, 89% of whom had grade C/D disease who were compared with 30 propensity controlled children in the magic cohort. An expanded access protocol, overall survival of which has been analyzed in 241 children where remestemcel was used as salvage therapy after failure of steroids and other biologic agents. And finally, a subset of that study and expanded access protocol around a controlled study against propensity controlled children in the CIBMTR database. As you can see, in each of these studies, short-term survival of day 100 was high in all of the remestemcel-treated cohorts, including just the Grade D patients in the expanded access protocol. And you can see that in the matched controls, propensity matched controls, as outlined, the short-term survival was substantially less than with the remestemcel. If we go to the next slide, please, Slide 15. This slide now…

[Operator Instructions] Our first question today comes from Louise Chen from Cantor.

This is Carvey on for Louise on Cantor. Congrats on the progress. First, on remestemcel-L commercial front, can you comment how quickly you could launch the product after approval in acute GVHD? And when do you expect a potential approval? What are the remaining steps to get there? I have a follow-up question after this.

Sure. Thank you. So of course, we have a priority review designation for the product. We are working towards a complete response the FDA that addresses their issues around the clinical survival data, potency assays and relationship between potency and survival. And all of those data have been provided in a submission to the IND to the FDA about 6 weeks ago, and these new survival data will fall now the cornerstone of the rest of the documentation to the FDA. We would expect that somewhere between the statutory requirement is to complete the review between 2 to 6 months. And we are building out our commercial capabilities putting in place with the team that will lead the interactions with the payers and with the key opinion leaders at the end users to the hospital, and we should be in a position [indiscernible] if we get approval to launch the product immediately after approval.

Got it. Awesome. Our second question is on your heart failure opportunity. What is the pathway to approval look like in this opportunity?

We expect to be meeting with the agency over the next couple of months. And the data before them is the totality of data in patients in Class II, III heart failure from the DREAM trial, as well as in patients with end-stage heart failure that previously generated in patients with LVADs. What we're seeing is a continuum of improvement in systolic function in patients with inflammation, whether they're last 2, 3 or 4 disease. So I think that's the basis of the discussion. We already have an RMAT in place that focuses on the LVAD population. So we will be having a discussion around it. The continuum of the data set, not just in the LVAD population, but in the broader class [indiscernible] patients with high CRP.

[Operator Instructions] Our next question comes from Edward Tenthoff from Piper Sandler.

Great. Thank you very much. So Silviu I'll not split hairs, but I really want to just understand the exact process under the new survival data that you included in the IND, does that constitute the response to the CRL? And does this 2- to 6-month clock kind of start ticking from October 3. And then I have a follow-up there.

No. The survival data we've just provided today has just become available to us. So today's announcement is the new data that has been generated by CIBMTR completely independently. That has not yet been provided to the FDA and will now be filed with the FDA. So the clock is not [indiscernible] until these data are in the hands of the FDA.

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

Very short term.

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.

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?

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.

We're waiting for specific dates.

Got you. And Eric? Yes, go ahead, sorry.

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.

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.

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.

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.