Good morning, good afternoon to Mesoblast’s Financial Results and Operational Update for the Half Year ended December 31, 2023. With me on this call are our Chief Medical Officer, Dr. Eric Rose; Interim Chief Financial Officer, Andrew Chaponnel and one about Mesoblast Board members. Dr. Philip Krauss. If we could go to slide 4 please. Snapshot of the investment highlights Mesoblast. And on this slide, we're developing a novel allogeneic cell therapy technology platform to enable treatment without the need for donor matching or immunosuppression. The lead indications program, two platforms, Remestemcel and Rexlemestrocel. Remestemcel is being developed for both pediatric and adult steroid-refractory acute graft versus host disease. The pediatric indication, we've completed a single-arm pivotal Phase 3 trial which met -- successfully met its primary endpoint. Long-term survival data shows durability of survival benefit for more than four years. New data from a second potency assay has been provided to the FDA and we have an upcoming meeting scheduled during March. For adult steroid-refractory acute GVHD. We are collaborating with the bone marrow – blood and bone marrow transplant clinical trials network body responsible for approximately 80% of all US transplants to conduct a pivotal trial in adults with this condition, patients who have failed second-line therapies and have no approved therapeutics. This potential market is five times larger than for pediatrics. Rexlemestrocel our second generation immuno-selected product being developed for heart disease and for inflammatory back pain. In the field of inflammatory heart failure was low ejection fraction was completed the Phase 3 trial. We have an FDA designated regenerative medicine advanced therapeutics designation for the product in the treatment of the most severe end-stage patients. It's the ejection fraction -- low ejection fraction heart failure and with ventricular assist device. And under the RMAT we had…

Yes, thanks Silviu. Please turn to the financial highlights for the half year on Slide 15. As at December 31 2023, cash reserves were $77.6 million after completion of an institutional placement and entitlement offer of AUD60.3 million in the period. During the period, we also delivered on our planned cost containment strategies, which reduced our cash burn for operating activities. In the three-month period ended December 2023, our cash burn for operating activities was $12.3 million, which is a 25% reduction on the comparative three-month period in FY 2023. In the six-month period ended December 2023, the cash burn was reduced but 14% on the comparative six-month period in FY 2022. We are also pleased to report the 21% reduction in our loss after tax of $32.5 million. Turning to Slide 16, you'll see we are reporting a reduction in all our key categories of expenditure and improved loss after-tax for the half year ended December 2023. Our revenue of $3.4 million is predominantly from royalties on sales of TEMCELL in Japan and our manufacturing expenditure reduced by $6 million or 47% for the six months ended December 2023. The cost being incurred in the current period for manufacturing related to generating new potency and characterization data through our remestemcel-L product for children with acute graft versus host disease. This data has been submitted ahead of our upcoming meeting with the FDA next month. Our finance costs include $6.9 million of non-cash expenditure for the six months ended December 2023. I'll now hand the call back to Silviu for the presentation. Thanks Silviu.

Thank you, Andrew. Let's continue with our operational update. Slide 19 please. Steroid refractory acute graft versus host disease is a devastating complication of a bone marrow transplant. More than 30,000 allogeneic bone marrow transplants performed globally per year, of which approximately 10,000 are performed in the U.S. 1,500 of these 10,000 are in children. And for children, there are no approved therapies at all. For adults, adolescents and adults over the age of 12, ruxolitinib is the only approved therapy. And 45% of those who receive ruxolitinib are non-responders. For the non-responders, there are no approved therapies. If we go to Slide 20 please. This slide summarizes the three studies that have been provided to the FDA on the outcomes for remestemcel in children with steroid refractory acute GVHD. And in these three studies, you'll note that day 100 survival ranged from 66% in the most severe conditions under an expanded access to 74% and 79% in both the randomized controlled study and in the open-label study, 001, with a grade C/D disease accounted for 89%. In contrast, in each of these last two studies, control arms, either a randomized control arm or an external control arm matched patients demonstrated substantially lower survival outcomes of 54% and 57%, respectively. Go to the next slide, this graphically shows a comparison of survival on the right-hand side in our Phase 3 trial 001 where, at six months, we see 69% survival. And by two years, 51% survival of children where, as I mentioned earlier, almost 90% have the worst form of disease grade C/D disease. In contrast, on the left-hand side, we see two-year survival outcomes in 128 children with steroid-refractory GVHD treated at major center across the U.S., and you see a dismal 35% survival at two years in this…

Thank you. [Operator Instructions] Your first question comes from Louise Chen with Cantor Fitzgerald. Please go ahead.

Hi. Congratulations on all the progress, and thanks for taking my questions. So, I wanted to ask you on the pricing for the pediatric opportunity for remestemcel. I think last time I spoke with you what the pricing was but frankly better than I had anticipated. So just curious what you're thinking there? And then I also wanted to ask you about cash runway. I know you gave a cash balance, how you think about the push and pulls? And then lastly, just OpEx for the remainder of the year up, is this first half of the year? A good proxy for that, or is there something else happening in the second half that we should consider? Thank you.

Thanks, Louise. So with respect to pricing, as you can imagine, we're not able to disclose publicly, what we expect to charge for the product for pediatric graft-versus-host disease. But are you know, I would point you in the direction of the CAR T-cell therapies as precedents for similar patient populations. And you want to look at the totality of the disease in terms of morbidity and mortality and the durability of the effect. We've demonstrated at least five years of survival outcomes. And I think when you and some of the gene therapies that I'm providing that kind of curative outcomes charge some pretty remarkable prices. I would say that we would see that the pricing for this product is somewhere between the khaki products and the maturity of gene therapy product. With respect to the burn rate and I think runway, we've indicated that in the last quarter, our financial spend and our burn was reduced 25% relative to the comparative period. And I think we're very comfortable that we're going to maintain that kind of quarterly burn perhaps even tighten our belts further beyond that. So on that and that's how that allows us to complete both the adult GVHD program that we are planning to do with the BMTCT and group, as well as the pivotal back pain trial. So, the current spend anticipates those programs being funded internally. We on that basis we think we've got to about at least 12 months of cash. We expect and are currently in discussions with strategic partners for some of these indications where we -- if we enter into strategic partnerships particularly in the US market, we would expect that cash flow, cash balance would be substantially altered. I would extend our runway well beyond that. Does that address your question Louise?

Yes, it does. Thank you, very much.

That brings us to the end of today's call. I'll now hand back to Dr. Itescu for closing remarks.

We hope that we've given a good update on our operational activities which have been substantial at least over the past quarter. We will continue to update the market as we deliver on the on the near term and midterm catalysts as we've laid them out. And thank you very much for participating.