Thank you all for standing by. Hello and welcome to the Mesoblast Financial Results for the period ended March 31, 2023. An announcement and presentation have been lodged with the ASX and will also be available on the home and investor pages at www.mesoblast.com. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference is being recorded. Before we begin, let me remind you that during today’s conference call, the company will be making forward-looking statements that represent the company’s intentions, expectations or beliefs concerning future events. These forward-looking statements are qualified by important factors set forth in today’s announcement and the company’s filing with the SEC, which could cause actual results to differ materially from those in such forward-looking statements. In addition, any forward-looking statements represent the company’s views only as of the date of this webcast and should not be relied upon as representing the company’s views of any subsequent dates. The company specifically disclaims any obligations to update such statements. With that, I would now like to turn the call over to Dr. Silviu Itescu, Chief Executive Officer of Mesoblast. Please go ahead.

Thank you, operator. Good afternoon, good morning to everybody on the call to our operational highlights and financial results for the quarter ended March 31, 2023. If we could, go to Slide 4 please. On the call with me today is our Chief Medical Officer, Dr. Eric Rose; and our Interim Chief Financial Officer, Andrew Chaponnel. Slide 4 shows a snapshot of the investment highlights. We have a novel allogeneic cell therapy platform with two lead candidates both being platforms for multiple products and indications. Remestemcel-L, rexlemestrocel-L, each have got their own specific indications and I’ll be talking in detail in this presentation on both of those platforms. Financially, we have substantial cash on hand and there’ll be a detailed presentation by Andrew Chaponnel on our finances for the quarter. Next slide please, Slide 5. This slide is a summary of our late-stage clinical pipeline based on our mesenchymal stromal cell platforms. As you can see, remestemcel-L for pediatric steroid refractory GVHD graft-versus-host disease is the most advanced, and it’s currently before the FDA with the review of the BLA with a PDUFA goal date of August 2, 2023. The manufacturing inspection has been conducted and I’ll talk more about that shortly. Remestemcel-L is also being developed for adult steroid refractory graft-versus-host disease, acute respiratory distress syndrome, and inflammatory bowel disease. Rexlemestrocel-L second generation stromal cell platform is being developed for chronic inflammatory low back pain, discogenic low back pain and rexlemestrocel-L is also being developed for inflammatory heart failure. And for both these indications, the FDA has granted Regenerative Medicine Advanced Therapy designations. We can now go to the next slide and I’ll hand over to Andrew to talk about our financial results, please.

Thanks, Silviu. If you could, please turn to the financial highlights for the third quarter of FY 2023 on Slide 7. For the quarter, revenue from royalties on the sales of TEMCELL in Japan by our licensee were $1.8 million. On a constant currency basis, royalties grew 4% in the quarter to $2 million. For the 12-months we recognized revenue of $7.6 million from royalties on product sales. Net cash usage for operating activities in the third quarter was $16.2 million; this represented a 4% increase on the third quarter of FY 2022, and a 34% reduction of $8.3 million on the third quarter of FY 2021. In April, we successfully completed global private placement of $40.0 million through existing major U.S., UK, and Australian shareholders. As of March 31, 2023, cash-on-hand was $48.8 million. We have a pro-forma cash of $88.8 million after adjusting for proceeds of $40 million raised in the April private placement. We also have up to an additional $40 million available to be drawn down from existing financing facilities subject to achieving certain milestones. Turning to Slide 8, you’ll see we are reporting an improved loss before tax for the quarter. Revenue is predominately from royalties on sales of TEMCELL in Japan and despite an increase in underlying sales volume of 4% in the third quarter of FY 2023 compared to the third quarter of FY 2022, reported revenue decreased slightly given that Japanese yen has depreciated against the U.S. dollar. Our R&D expenditure was reduced by 14% for the quarter. Our R&D spend in the quarter was primarily to support the remestemcel-L BLA re-submission and preparation for pivotal studies of rexlemestrocel-L. We continued our investment in manufacturing activities to support the potential launch of remestemcel-L for the treatment of steroid refractory acute GVHD. On FDA approval, $31 million of remestemcel-L relaunch inventory will be recognized on the balance sheet. Finance costs for the quarter includes $3.8 million of non-cash expenditure comprising accruing interest and borrowing costs. Now, hand the call back to Silviu for the end of the presentation.

Thanks, Andrew. Slide 10, please. This slide summarizes the mechanistic process that this acute graft versus host disease, a fatal complication of an allogeneic bone marrow transplant, essentially following chemotherapy, there is extensive tissue damage in the patient who subsequently receives an unrelated donor bone marrow transplant. The transplant then attacks the body through defined pathways that are driven by T cells. T cells are activated, they’re the orchestrator of multiple cytokines produced by other cell types resulting in a cytokine storm, which is destructive for the gut, the liver, the skin, and other organs. And in those patients who have the most severe organ disease, mortality approaches 90%. If we could go to Slide 11, please. So the market opportunity for Mesoblast is large, more than 30,000 allogeneic bone marrow transplants are performed globally. Of these, about 20% of pediatric, we are targeting the most severe cases, we initially targeting pediatric GVHD and intent to target the more severe adult cases as well. Next slide, please. Slide 12 summarizes the survival data across three different studies involving more than 300 children treated with remestemcel-L. These studies were designed to demonstrate whether remestemcel-L provided an early survival benefit. Three studies outlined here include a randomized controlled subset of 27 children within an earlier study called Protocol 280. The second study was a pivotal Phase 3 trial called Study 001, and the third study was an expanded access protocol of 241 children who received remestemcel-L having failed other available therapies. What you can see here is that in each of the three studies there is a substantial early survival benefit from 66% in the sickest children were remestemcel-L was used as salvage therapy to 79% in the randomized controlled subgroup study. And the comparators for each of these outcomes showed substantially…

Thank you. Your first question comes from Edward Tenthoff from Piper Sandler. Please go ahead.

Great. Thank you guys, and thanks for the detail on the presentation. So my friend Mike, was wondering what still has to be done for the ahead of the NDA? Are there any remaining pieces that need to be filed or any interactions with the FDA or at this point, are we really just waiting for this to do today? Thanks.

Well, having completed the manufacturing inspection which was the biggest item still outstanding, we continue to interact with FDA on a variety of questions that backwards and forwards in regard to the review. But other than that, really the major item that remains outstanding is a discussion around the specifics of the label. And that’s really – that still remains ahead of us and we’re very excited as we proceed towards the PDUFA date.

Absolutely. Well, excited for upcoming approval. And then when it comes to lower back pain, what are the steps in order to initiate that base rate? Is that such an exciting opportunity today?

So we have alignment with the FDA on the protocol itself. We’ve already manufactured the product for the trial. We will be having a discussion with the FDA under the RMAT designation to ensure that we have our approach aligned in terms of manufacturing potency and the like. Those we will be proceeding in parallel with commencement of the study. We expect to initiate enrollment across about 40 sites in the U.S. in the third quarter, calendar quarter. So we’re on track to get things going.

Awesome. Great news. Thanks, Silviu.

Thank you.

Thank you. Your next question comes from Louise Chen from Cantor. Please go ahead.

Hello, everyone. This is Carvey on for Louise Chen from Cantor. Thank you for taking our questions. First, your PDUFA date is fast approaching. If approved, how quickly can you commercialize the product? And secondly, how are you thinking about OpEx for the rest of 2023 and 2024 fiscal years? Thank you.

We have the commercial team that is currently in place and building. It will not need a very large footprint. We expect to have about 15 or so sales force in place at the time of launch. The launch is going to be a targeted launch initially focusing on the highest volume transplant centers, but we should be ready to launch as soon as we’re approved. We have already got inventory in place. The discussions are ongoing now with payers. Reimbursement will take some time, of course. But we should be in a position to initiate launch as soon as we’re approved, although the pace of the launch is going to be staged. In terms of CapEx, I think you asked or OpEx rather. We don’t see in the short-term changes in quarterly spend. Other than as we have product approved, we will be seeking – we will be looking towards label extension, particularly in adult GVHD as the first cab off the rank. And so how we fund that program is really a flexible possibility. We have access to additional capital throughout financial structures that are currently in place through debt. We have – are in discussions with various strategic financial partners around royalty based structures, et cetera. But in general, I think our plan at the moment is to maintain the current OpEx spent on a quarterly basis.

Got it. Thank you. Looking forward to the PDUFA date. Congrats on progress. Thank you.

Thank you. Your next question comes from Sami Corwin from William Blair. Please go ahead.

Hi there. Thanks for taking my questions. Hi, thanks for taking my questions. I was curious if there are any other possible alternatives in terms of the outcome for the EIR other than the FDA, just kind of giving you guys a thumbs up. And then with regards to the study in steroid-refractory aGVHD in adults, how exactly could that trial differ from study 001 and study 280 in terms of design and potential endpoints? Thank you.

Okay, thank you. So the first question was about the expected EIR in the next couple of weeks on the manufacturing inspection. Look, we – it’s hard to anticipate what the observations and the final determinations of the FDA on manufacturing inspection. But I will say that a 483 Form can only be provided at the end of the inspection when the FDA and the facility, and the company are face-to-face. And the 483 Form was not provided, so that cannot be provided later. So we’re very pleased by that. In other words there are no – there are no official outcomes that would’ve been required for improvements under 483 Form. There may be other small issues that that come up in the EIR that’s the final document, but the kind of major concerns that that are in 483 will not be there. With respect to an adult program, I might just ask Eric, Eric, would you like to comment on how you see an adult program going forward?

Can you hear me?

Yes, we can.

Good. We have had 10th interest in our product on the part of adults oncologists that face the same problem as the pediatric oncologist. Whether or not it will – what type of trial we’re discussing with members of the CIBMTR now there is a clinical trials group that is supported by the NIH that we’re in discussion with about doing a trial on adults that presumably will extension the label to that age group as well, but the design of such a trial is still outstanding.

Yes. And I think we have flexibility in thinking about the degree of severity in the adults whether we use a randomized control design or whether we use a propensity matched control design. I think all of those are on the table, and they will form part of our ongoing discussions with the FDA.

Great. And then just one more if I can. Considering you plan on running two Phase 3 trials and potentially launching the aGVHD product. Do you think you have enough cash on hand to accomplish all near-term milestones? Thank you.

Yes. As I said earlier, there are multiple alternative ways by which we may fund these various trials. And they include collaborations as Eric just mentioned with academic groups like the – like NIH or registries like CIBMTR, for example, and that that would have a substantial impact on our resource allocation. Secondly, there are financial groups that – that we are in discussions with who are interested in potentially royalty based structures that would again, defer our spend requirements. And thirdly, we have access to up to an additional $40 million in pre-arranged debt structures with our existing facilities that become available post FDA approval, should we want to access them.

Great. Thank you and congrats on the progress.

Thank you.

Thank you. Your next question comes from John Hester from Bell Potter. Please go ahead.

Yes. Good morning, Silviu. Just want to take you back to Slide 21 on the right hand side of that chart, which talks about the Grade D banded access program a 100 survival rate and in the Ryoncil line that suggested that the survival rate there was 72%, and that’s in Grade D patients, who are the sickest of the sick. So just confirm for me, is that Ryoncil product, that’s – that was the product that was used, in your clinical trial, correct. So what is…

That is correct.

Yes. So what’s the difference between that survival rate, 72% and the low 53%? I think it was, or 51% in the data on Page 18.

Yes. That 50 – yes, I’m sorry. On Slide 18…

Survival.

Yes, that’s 51% at two years. The data that we’re talking about here in on Slide 21 is 72% at three months, the 100.

Okay.

That’s right. So it’s early survival data in the EAP, which only followed up children through 100 days. And then the longer term survival of our Phase 3 trial is now out to four years. Even a 51% two-year survival rate is substantially greater than the survival in the mid-20s to mid-30s with best available therapy, which includes ruxolitinib in other studies.

And is there any confusion now as to the level of potency that the product that’s been manufactured in recent years will deliver? Because this analysis indicates there was a significant difference between the earlier Prochymal product and the – products…

That’s precisely the point. That’s exactly the point. The clarification has come through the analysis that demonstrates that improvement in manufacturing, changes in manufacturing, which were implemented in, at a particular point in time in the development history of the product, delineates a more potent product currently in use in our studies from the less potent product that was called Prochymal that failed in other earlier studies. And so we believe that the, the reason that we’re seeing greater clinical outcomes with our newly improved product is because of its greater potency as measured by our validated potency assay. And that is very encouraging both in terms of the pediatric data and the data that we expect to generate in adults.

So to what extent has that – new data on the potency been available in over the last two years since the complete response letter? Or has that always been available?

No, these are data that are newly generated as part of the BLA resubmission in alignment with optimization of the potency assay. But the assay itself has been in place and was in place when products were being used in both the EAP and the Phase 3 trial. And so what this provides us now is an understanding of how changes in manufacturing have resulted in a more potent product, which correlates with better survival.

Okay. And just finally during the inspection of the plant in Singapore, was the inspectors able to see product being manufactured at that time? Assume that they were.

Yes. The reason for the inspection is that four inspectors were on site and observing the entire manufacturing process from beginning to end over a 10-day period, every detail of the manufacturing process was observed and inspected.

Excellent. That’s all for me. Thank you.

Thank you.

Thank you. As there are no further questions at this time that brings us to an end of today’s call. I’ll now hand back to Dr. Itescu for any closing remarks.

Great. Thank you everybody for joining us today. We’re very excited about how the process is evolving on the BLA resubmission and our interactions, very collaborative interactions with the FDA. And we look forward to the upcoming PDUFA decision date. As we build out our plans for hopefully a successful outcome and a post-approval launch. Thank you everybody.

That does conclude our conference for today. Thank you for participating. You may now disconnect.