Good evening, everyone. My name is Ted Tenthoff. I'm a senior biotech analyst at Piper Sandler, and before I begin, I am required to point out certain disclosures regarding the relationship between Piper and our next presenting company, Mesoblast, which are our products at the back of the room and also the registration desk. So congratulations. Mesoblast is successfully launching Ryoncil to treat steroid-refractory pediatric acute graft-versus-host disease. This has been a long path to get here, and the launch is going really fantastically well. The company plans to conduct a single-arm study, confirmatory study in adults. You're also preparing to file potentially a BLA for Revascor in heart failure patients with a left ventricular assist device, and also conducting a confirmatory study in heart failure and Phase Iii trial of rexlemestrocel-L for chronic lower back pain. So no shortages of work to be doing. Here today is my good friend, Dr. Silviu Itescu, CEO of Mesoblast. Always, always good to see you. Thanks for having us today. So we could kind of start in a lot of different places, but I think I'm just going to say you deserve the gold medal for persistence in biotechnology. Ryoncil is off to a strong launch in pediatric acute aGVHD. Net sales were $30 million in the first two quarters. I think you guys just guided at the annual general meeting that this quarter could be greater than $30 million again. So we're really seeing a nice spike. What's accounting for the success rate? How large is this pediatric market? Yeah. Well, you know, we got approval in December last year. And we had a couple of hiccups along the way. And so we really had to. We started from a standing start. We were watching our investment, and we started. We built a commercial team. We hired a strong, strong leadership team inside the company. And really, the first quarter was all about getting sites on board, getting coverage from commercial payers, getting coverage from CMS, et cetera. And that laid the foundation for how the launch has gone this year. And I guess we put a lot of things right. We learned from predecessors, and we learned from how to price this appropriately. Remember, this looks like a product that's a curative product for a disease that's otherwise potentially fatal. And so I think we got the pricing and reimbursement right to date. 260 million lives covered by the commercial insurance that cover us. We had Medicaid CMS coverage federally early on, efficiently, and by July 1, mandated coverage by all the state Medicaids. In October, we just got a J-code. I think all of those things together, as we've put them in place, have put us in good stead. The trickiest part early on was the bureaucracy at the institutional level and the uncertainties whether the institutions would get reimbursed, et cetera, which took some time. I would say all of that is behind us. What's most interesting now is that centers that have treated one patient, two patients, are now having had good experiences, have seen how the patients have done, have seen how reimbursement is occurring, and now repeat customers. We're seeing that all over the country, actually. We're seeing adoption that is going really well. I would say at this point, you know, we've maybe reached 10% of our market. I think if we can get to 30% in a 12-month period, it would be a tremendous outcome. Look, I think so far things are going really well. Yeah, I agree. And at the heart of this is really this unmet medical need for these children who are just literally peeling out of their skins and dying. You know, they already have cancer, and now they get graft-versus-host disease. It's a devastating complication that had, you know, before our cells were approved, had a mortality rate of 70%-90%. And I think, you know, Phase Iii trial demonstrated that we could get, you know, we reduced that to about 20% early mortality. And those children who went into remission in that first 28-day period pretty much were alive five years later. In other words, almost a curative outcome. And I, you know, I think the growth here is not just in the 300-375 new cases that are done per year with steroid-refractory disease, but the fact that physicians are being re-educated in terms of thinking that when a child has steroid-refractory disease, the first thing they should be thinking is use Ryoncil. Ryoncil is the only approved product for children under 12. And it makes a difference. The earlier you start using it, the more likely it is that a child goes into remission and survives. What we're educating physicians is not to think about the old drugs they used to use that are off-label that they're comfortable with, but as soon as they can identify a child not responding to steroids, don't lose time. Jump on it and use Ryoncil. And it can be. It's approved and it's paid for. Right. Now, the bigger opportunity here, the bigger market from a patient number are adults with acute graft-versus-host disease. Tell us about your plans to run Phase Iii trial and sort of where the FDA is for requirements for that label expansion. The real unmet need in adults and a market that is three times bigger than the pediatric market is in adults who've steroid-refractory disease and have got Grade C-D disease, severe disease. It's about 50% of the adult market. There is a drug that's approved, ruxolitinib. ruxolitinib is approved in first line after steroids and is used routinely in all adults. However, in Grade C-D disease, severe disease, it doesn't work very well. And while the responder rate with ruxolitinib is about 80% in Grade II, it's of the order of 45%-50% Grade III, IV disease. That's where the unmet need is. Now, under expanded access, under compassionate use, a lot of physicians have been referring patients who failed ruxolitinib to us. And we've been using our cell therapy as third line in those cases. In that setting, we've changed the outcome pretty dramatically from a 25% survival, dismal 25% survival in three months, to about a 70% survival at three months. We talked to our collaborators, the Bone Marrow Transplant Clinical Trial Network across the US. It's an NIH-funded network about what a pivotal trial in this disease would look like. We went to the FDA. The FDA said, look, rather than a trial in third line after they've already failed ruxolitinib, what you should really do is a trial in second line because that's where the need is. That's what we've come down to, to a randomized controlled trial, not a single line, but randomized controlled, these Grade C and D patients and combining our cells on top of ruxolitinib, comparing the outcome against ruxolitinib alone. That study is actively starting up with the Bone Marrow CTN group. The clinical protocol is now locked in. We've asked the FDA to sign off on that protocol. And we'll begin enrollment across about 80 sites across the U.S. But what's important is that this provides the opportunity for Ryoncil to be available as really first line after steroids as part of the regimen as soon as a patient is identified as being severe disease. That's the growth opportunity for this drug. How quickly do you think you could run Phase Iii? when do you think you might get the label expansion? Look, we're looking at potentially a 12-month enrollment period, and beyond that, we'll be at 28-day primary endpoint, so we're looking at 2027 filing and potential label extension. Yeah, very exciting. And again, an opportunity to build on the success that you're having with Ryoncil and kids. What about overseas? Are there markets to treat overseas? I know there's all this confusion now with pricing. And if you price it lower overseas, you can't. You know, what's the thinking? Look, in parallel, we'll be filing for regulatory approval in Europe using the FDA, the FDA documentation to file for EMA approval. But you know, we've got so much on our plate in the US. To be honest with you, the unmet needs beyond GVHD for this drug, you know, GVHD is inflammatory bowel disease at its max. So if we can induce remission in inflammatory GVHD with bowel disease, surely we can have an impact on inflammatory colitis. And we've previously had both pilot studies as well as randomized controlled studies where the cells have been injected locally and intravenously, showing strong evidence of early remission in inflammatory colitis. And that's a big area of unmet need, particularly in those patients who failed one or two biologics, continue to have an unmet need in terms of need for early remission and avoidance of the terrible outcomes like colectomy. That for us is a big area of focus. The other areas are rare inflammatory diseases in children. Again, the fact that we've got such a safe product with hundreds of children's worth of safety data makes us a unique approach. And you know, there are a number of very bad inflammatory diseases of neurodegeneration, of muscle disease, et cetera, where inflammation continues to be a big problem and where our cells, especially given their potency and their safety, would find a real special area of focus. It's such a cool opportunity. And again, you solved the hardest part of the equation, which is the safety side. You know it's working. So would you do these studies as ISTs or investigator-sponsored trials, or would these be company trials that you would do? It's interesting because we're hearing from the FDA leadership, for example. There's a whole focus on streamlining clinical programs. They want to see randomized controlled data when it's possible, but innovation, right? And innovation means working with physicians, investigator-initiated studies. Physicians are coming to us with proposals. So providing that the trials are done in a legitimate way with oversight, et cetera, et cetera, they don't have to be corporate-sponsored, right? And I think we want to leverage those opportunities. And we're looking at those very closely right now. I want to make sure we save time for the other things. Just when it comes to manufacturing, how are you guys making Ryoncil? It's made from human donors, U.S.-based donors. The product is initially manufactured in the U.S. The core product is all U.S.-made. Some of the expansion part is made outside of the U.S. and then brought back in. As we move forward, I think most of the expansion will also be done in the U.S. Our focus is U.S. manufacturing as we grow, especially as we look for new opportunities and new indications. Cool. So switching gears to Revascor, tell us about the mechanism in cardiovascular disease and sort of your regulatory plans here. You know, both Ryoncil and Revascor, the second-generation product, have a very common shared mechanism of action. They actually activate resident cells that are anti-inflammatory in each of our major organs. And they turn off the bad players, the pro-inflammatory macrophages that cause a lot of tissue destruction. That's common to our cells. And they're sort of the master regulators of anti-inflammation, if you like. And so we look at what diseases potentially are driven by inflammation where existing small molecules or monoclonals, for example, don't work. And that's how it's led us to certain indications that we've targeted. They don't have to be. Our cells don't have to be intravenously delivered. They can also be locally delivered. So especially Revascor, our second-generation product, very potent product. It's being used through local delivery in both the intervertebral disc and in the left ventricle into the myocardium in tissues that have active inflammation. And we can measure inflammatory response through a whole bunch of biomarkers, simple tests in the peripheral blood. And that also goes through some pulmonary indications that are also pro-inflammatory. So we identify patients based on blood testing for evidence of inflammation. And then we deliver the cells different concentrations, different dosages to that site. In the myocardium, it's well known that inflammatory macrophages drive the process. And particularly in patients with ischemic heart disease, they're full of inflammation. We measure the inflammatory biomarkers in the peripheral blood. In that group of patients, in a first 500-patient trial, randomized controlled, in the ischemic inflamed patients, we reduced the major complications of heart attack, strokes, and death by anywhere from 60%-80% on top of maximal standard of care from a single injection through three years. That's in patients Grade II, III disease, severe disease patients. In the most severe patients, these are patients who are end-stage disease being kept alive by an artificial heart, ischemic heart failure on a VAD, ventricular assist device. That group of patients continues to have bad outcomes even when they have their VAD put in. They have GI bleeding. They have a lot of inflammation, ultimately a high mortality even as early as 12 months. In that group of patients in a randomized controlled study in ischemic patients, we improved the strength of the left ventricle. The left ventricle machine could be turned off and they could tolerate it. And that improvement in strength of the left ventricle resulted in survival improvement through 12 months. And that improvement in survival is the basis of why we think we have an opportunity for an early approval in this indication with obviously a confirmatory trial in the larger group of patients, those with Class II, III heart failure. We have alignment with the FDA on what a confirmatory trial will look like. And that primary endpoint of 3-point MACE, which we've previously achieved, would be the confirmatory endpoint. When do you anticipate filing for the left ventricular assist device patients? Look, sometime in the first quarter. The timing is dependent on having manufacturing ready to go, having commercial manufacturing scalable and in a position to be part of the BLA filing. The second indication of this product, though, is as exciting, if not more exciting, than cardiovascular disease, and that's inflammatory pain. In a Phase Iii trial in inflammatory back pain caused by inflammation with severe pain, a single injection into the disc resulted in substantial reduction in pain at 12 months. 50% of the patients had no pain by 12 months, which is effectively remission, and these patients continue to have improvement in pain through at least three years, and that's the basis of a second trial that is now active and ongoing that will complete enrollment in the first quarter and then with a 12-month readout again on reduction in pain. That's a pathway to a traditional approval. Huge opportunity if the readout is positive, but in addition to that, what we've seen in that first 400-patient trial is that in the 40% of patients who are dependent on opioids, not only did a single injection reduce their pain for the duration of three years, but the pain reduction predicted and was associated with substantial elimination of opioids, so that by three years, three times as many patients who had received a shot of our cells actually came off opioids compared to controls. We have a meeting next week with the FDA to discuss in particular the opioid avoidance data, given the recent guidance the FDA put out that they're looking to support innovators who are developing non-opioid drugs for chronic pain, and we have a lot of data beyond just back pain. We also have data where the same product injected into the knee joint, for example, at the time of an ACL repair, resulted in over two years of pain reduction, functional recovery, and radiographic evidence of cartilage protection. So there's a common theme that this is decreasing inflammation resulting in durable pain relief. And in the current opioid crisis, that's a very important product to be developed in the setting of opioid avoidance. Silviu, you've done a great job helping financing a company. Now you're generating sales in a commercial organization. Where's the current cash and debt levels? How far does that take you? We had about $146 million end of last quarter. You know, we're talking about this quarter having north of $30 million in revenues. We've done a good job in managing our cost base. You know, people have asked me the whole time, are we going to be break even by the middle of next year? Could very well be. I think, you know, the point here is to manage our cash flows in a very careful way whilst ensuring that our growth is supported by our cash position. I think, you know, we've got lots of options. The question is, you know, how quickly do we grow and how quickly do we manage our cash? Silviu, last question for you. You've partnered with Grünenthal in Europe for chronic lower back pain. I think all the rest of this is still completely wholly owned. Do partnerships make sense for some of these indications? I think the whole thing here is to accelerate development and unlock value as quickly as possible in a parallel timeframe. The approved product, Ryoncil, has applications well beyond GVHD. We've mentioned inflammatory bowel. We've mentioned pulmonary. We haven't mentioned neurodegeneration. But inflammatory brain disease, including Alzheimer's, is a whole other growth area. You can imagine that we're in discussions with a number of potential partners that have interests across the board that would be real partners, alliances. Alliances where we can really both contribute co-development, co-promotion, co-investment. And that's where I think the future for Mesoblast is. Go after the big game. Exactly. Silviu, always a pleasure, my friend. Thank you. Thank you, everybody. Thanks for having me.