Good morning, everybody. I'm Silviu Itescu. I'm the Chief Executive of Mesoblast. Together with me this morning is Marcelo Santoro our Chief Commercial Officer; and Andrew Chaponnel, our Interim Chief Financial Officer. Today, we're presenting our financial results and operational update for the half year ended December 31, 2024. We could go to Slide 4, please. Mesoblast is the global leader in allogeneic cellular medicines for inflammatory diseases. We have one product already FDA approved, RYONCIL. We have multiple locations globally. We're listed duly on the ASX and NASDAQ. We have more than 1,000 patents and patent applications that support our products. Beyond our first approved product, RYONCIL, we have two other major products in Phase III, and we have a whole pipeline sitting behind these. We have scalable manufacturing that have been FDA inspected, and we have a supply chain capability that allows us to meet the global needs commercially. Next slide, please. Our platform technology is based on a shared mechanism of action across all of our products. Our mesenchymal lineage precursor/stromal cells are highly purified to very high concentrations in final cryopreserved vials. These cells have on their surface a range of receptors for inflammatory cytokines, including interferon gamma, TNF, IL-17, IL-6 and IL-1 and others. And when the cells are placed in regions of severe inflammation where these cytokines play major disease roles, they're able to respond to inflammation with the release of multiple anti-inflammatory factors that act in concert to turn of the damaging inflammation that results in severe diseases and potentially life-threatening outcomes. Next slide, please. This slide provides a snapshot of our clinical product pipeline. Our platform technology based on remestemcel, our first-generation product, trade name is RYONCIL, has now been approved by the FDA for the treatment of children with severe steroid-refractory acute graft versus host disease. I'll be talking a lot more about this product, which today we've announced pricing for that physicians can access. This product is also being developed for adults with steroid-refractory GVHD and will be developed for life cycle extension into inflammatory bowel disease in both children and adults. Our second-generation technology platform is termed rexlemestrocel. These cells are immunoselected using monoclonal antibodies to high purity and potency. And this technology is being developed for inflammatory cardiovascular disease and inflammatory back pain. More about that later. Next slide, please. Now I'd like to turn to Andrew Chaponnel, who's going to be discussing our financial results for the period ended December 31, 2024.

Thanks, Silviu. Turning to Slide 8 for the financial highlights for the year. Our cash balance at December 31, 2024, was USD 38 million with pro forma cash of approximately USD 200 million after the successful completion of a global private placement, which raised USD 161 million. Net operating cash spend was USD 20.7 million for the first half of FY 2025, which was a 22% reduction on the first half of FY 2024. As a result of FDA approval of RYONCIL in December, a $23 million provision against the value of inventory manufactured and expensed in prior periods was reversed and is now recognized as an inventory asset on the balance sheet. Turning to the next slide, you will see our P&L statement. The BLA approval in December resulted in noncash balance sheet adjustments, including the write-up of the value of inventory. Starting with the line items most affected by the non-cash balance sheet adjustments. Let's look at the results of both the revaluation of contingent consideration and the revaluation of the warrant liability. The increase in these line items in the current half year were as a result of FDA approval. Within contingent consideration on FDA approval, the probability of success of pediatric GVHD increased to 100% and resulted in a non-cash remeasurement increasing by $4 million to US$4.3 million for half one FY 2025 compared to $0.3 million for half one FY 2024. Within revaluation of warrant liability, as a result of FDA approval and the consequential share price appreciation, our warrant remeasurement increased by US$16 million to US$12 million for half one FY 2025 compared to a gain of $4.4 million for half one FY 2024. Within manufacturing as a result of the FDA approval the US$23 million provision against the value of inventory manufactured and expensed in prior periods was reversed. And as a result, we are now recognizing US$24 million of inventory on our balance sheet. The increase in expenditure for both our R&D and management and admin was due to non-cash share-based payments primarily for STI in lieu of cash-based payments. As described above, the BLA approval resulted in a number of non-cash balance sheet adjustments which drove the loss after tax of US$47.9 million for the half year. Pleasingly for the same half year period, our total operating cash flows were only US$20.7 million, a reduction of $5.9 million from the comparative half year. Back to you for the call, Silviu.

Thanks, Andrew. We can go to Slide 10. I'd like to talk now about RYONCIL, our launch strategy pricing and other guidance. RYONCIL is the first mesenchymal stromal cell therapy approved by the FDA. Next slide, please. The first FDA-approved off-the-shelf therapy for children aged two months and older including adolescents and teenagers with steroid-refractory acute GVHD, a life-threatening condition with high mortality rates. Next slide. We have the opportunity to address a very critical unmet need in children two months and older. Across the US, approximately 10000 allogeneic bone marrow transplants are performed annually. Acute graft-versus-host disease occurs in about 50% of patients. Approximately half of these fail to respond to steroids. And for those who failed to respond to steroids, mortality is very high and there are significant extended hospital stay costs. We believe that the addressable market in the US is approximately 375 new children per year with life-threatening steroid-refractory acute graft-versus-host disease. Next slide, please. In our Phase 3 trial that underpinned FDA approval, RYONCIL delivered high overall response rates at day 28, which is a measure well established to predict long-term survival in this disease. Overall response rates were 70% at day 28, significantly higher than is achievable with other therapy for this disease. Importantly, 89% of the children enrolled in this trial had the most severe form of the disease, Grade C/D, which involves the gastrointestinal tract and liver in addition to skin. RYONCIL treatment was not discontinued or interrupted in any patient for any laboratory abnormality and the full course was completed without interruption in more than 85% of patients. This is very different from the profile with other therapies used in these children with very severe disease as well as in adults with acute graft-versus-host disease. Next slide please. Now the cost…

Thank you. [Operator Instructions] We have the first question from the line of Edward Tenthoff from Piper Sandler. Please go ahead.

A lot of really exciting success going on here. I wanted to get a sense just with respect to the RYONCIL launch and I appreciate the color on the pricing. How large is the sales force? And because you've sort of had the expanded access program in place, how many centers are already trained on using RYONCIL? So, just trying to get a sense of how quickly this could really be launched in the U.S.? And then I have a quick follow-up question. thank you.

I'll just say that RYONCIL is already the standard of care in children with steroid-refractory acute GVHD. We have been providing it as you mentioned under expanded access. Quite a number -- most physicians and most transplant centers are very familiar with the product and are waiting -- literally waiting for this product to be commercially available so they can use it freely. I'll ask Marcelo Santoro to talk a little bit about his commercial team which is already in place. As I mentioned earlier, 80% of the transplants are performed across 45 sites. And Marcelo maybe you can talk about your strategy to get it across all those sites please?

No, that's great. So, thank you very much Silviu. Thank you for the question. It's a good one. So, I think as Silviu mentioned right so we've built and are continuing to build a world-class sales force with transplant experience. It's a small appropriately sized sales force of nine in total key account managers along with the head of sales force that will be focusing on this 45 key transplant centers. Obviously, we'll treat each transplant center as a key target a key customer for us. That represents 80% of the potential. And onboarding has already started. It actually started before we even hired the sales force. We've been in discussions with a lot of the centers at the moment. So that by the time the product is available at the end of the month, we're ready to roll.

Yes, I would say the other point that's important is we've already had inquiries, inbound inquiries from at least five to 10 -- or at least five to 10 children very sick who are waiting for product as we speak.

That's great. Well, it just shows you how important a product this really is and life-saving product this is. My second question had to do with respect to the chronic lower back pain ongoing trial and again this being another really important product. How far are you guys along in terms of enrollment? And when do you anticipate actually reporting data from that Phase 3 trial? Is your goal to launch that yourselves in the U.S. or seek a partner? Thanks.

Well, I would say that if we're successful this is a huge market opportunity. I mentioned earlier there's about 7 million people in the U.S. same type of number in EU5 to meet the criteria that patients are being enrolled at for this trial. And if successful, a single injectable will be a major immunomodulatory pain management therapeutic. You can imagine that the sales force required for targeting this patient population is substantial. In Europe, we already have a commercial partner in Grünenthal, the largest number one company in the pain space. They have the expertise across the major jurisdictions there both in terms of regulatory and reimbursement. We would presumably enter into a similar partnership in the US rather than invest our own in the distribution. You're going to see a ramp-up of enrollment in short order. We've invested substantially in sites. The number of centers that are coming on board that are onboard now is approximately 15. We expect over the coming four weeks to get up to about 40. And what happens is that as the physicians have more and more experience in terms of screening, evaluating, turning through the backlog of patients it becomes easier and you get that hockey stick takeoff. And so we have something like 20 patients currently in screening and that on a weekly basis that turns into an additional 15 to 20 new patients. So these numbers are rapidly increasing. So we have a target enrollment by -- towards the end of this year. But if we can compress it and bring it faster in then we'll certainly try to do so.

That’s really helpful. I know lot of my friends are interested in product like that. So, keep up the good work. Thanks for answering the question.

Thank you.

Thank you. We have the next question from the line of Michael Okunewitch from Maxim Group. Please go ahead.

Hey guys, thank you so much for taking my questions today, and congratulations on all the exciting progress.

Thank you.

I guess just to kick things off quickly looking at the math with a WACC price of $194,000 per injection, eight injections that's about $1.5 million per quarter of treatment. Am I getting that right? And then just what feedback have you gotten from payers on this pricing level?

Well, again, let me start by saying that based on health economic models, which reflect the net positive benefits of treatment with RYONCIL of between $3.2 million to $4.1 million, we have set the price per infusion at $194,000. The recommended dose for a child with steroid-refractory GVHD is twice weekly infusions of two million cells per kilogram for four weeks. So really the price that we've set per infusion is based on the economic value of the treatment and the product is available this quarter for physicians to order. The question around how physicians see the product here is entirely based on the clinical efficacy and on the results delivered to date and on the long-term survival benefits given the high mortality rate of this disease and the absence of any other treatment other than RYONCIL for children under 12. So I think everybody is pretty keen to get hold of the product. But Marcelo you might want to chime in. You were at Tandem. You led our clinical commercial interactions with all the payers and with the various clinicians.

So let's address both, right? So thank you Silviu. So first of all Tandem, we saw Tandem as our scientific launch. We had multiple activities during the convention. I think we could see the enthusiasm for the products and the level of questions asked in terms of availability when people can actually start prescribing the product. For us it was very, very encouraging. And the feedback that we received from most centers was also very well -- very important for us, right? So Tandem was a successful scientific launch. Now in terms of engagement with payers, obviously, we've been engaging with all payers for quite some time now. I think there is an appreciation for the low number of kids that is affected by this condition. So it's 375 kids. And also like this as Silviu mentioned this price is fair when you consider the benefit that RYONCIL provides to these kids. So, overall, I think the discussions have been very positive. I think there's an appreciation for the burden of the disease and there is also an appreciation for the long-term survival that RYONCIL offers these patients. So we are very optimistic and we're looking forward to next steps.

All right. Thank you for that additional color. And then just one more for me. I wanted to see, if you had any thoughts regarding December's FDA draft guidance on accelerated approvals, in particular how that could pertain to the Class IV heart failure program. Is there an expectation that you'll need to start up the Class II/III confirmatory, ahead of that filing? And then, just what are your thoughts on timing and next steps to get that confirmatory study going?

Yes. I think, this is the key -- the right key question, and we expect to be meeting with the FDA in the coming month or so or two months or so, time frame to clarify exactly that. We've put into the so-called briefing poster to be reviewed by FDA, the clinical trial design and the components of a confirmatory study that we would want to do post-accelerated approval. And so, the details of that are really what we want to discuss with the FDA. We would expect that given the severity of the patients, with advanced and end-stage heart failure and the mortality benefits that we've shown, that the FDA would want us to put the product on market, as soon as possible. And the arrangements or the discussions, with the FDA around the start-up and the agreement on the confirmatory trial design itself, I think would be a gating event. I'll come back to the Street, as soon as we have more clarity on that.

All right. Thank you very much once again for taking my questions today.

Thank you. There are no further questions, at this time. I'll now hand back to Dr. Itescu for closing comments.

Great. Look, I want to thank everybody on the line, who's listened to our presentation today. We couldn't be more excited, about how rapidly we're delivering this product to the children, who need it. There's a lot of work that is going on behind the scenes, at every level in the company from commercial, to manufacturing, to regulatory and the amount of effort that's going into doing this right and doing it in a way that we will save lives. And we're going to work with our partners the physicians, the institutions and the families, to make sure that we deliver a top-quality product that is going to save a lot of lives. Today, was a summary of the activities in the last six months, and I think you're going to hear a lot more from us in short order, as we move forward to start putting out our product and making it available in the marketplace to physicians and health care providers. Thank you, all.