Hello and welcome to the Mesoblast Financial Results for the Full Year ended June 30, 2024. An announcement and presentation have been lodged with the ASX and are 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 call 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 filings with the SEC, which could cause actual results to differ materially from those and 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 date. The company specifically disclaims any obligations to update such statements. With that, I would like to turn the call over to Dr. Silviu Itescu, Chief Executive of Mesoblast. Please go ahead.

Thank you, operator, and I'm very pleased to welcome everybody to the financial results and operational update for the year ended June 30, 2024. With me on this call are our Andrew Chaponnel, Chief Financial Officer; and one of our members of the Board, Dr. Philip Krause, formerly Deputy Director of the vaccines division of FDA's CBER. I'm very pleased to report that in the past six months, Mesoblast has made tremendous progress and we've built great momentum in our relationships with the FDA on each of our three lead products. We are now in a strong position to have our first potential product approved by the FDA and planning for a go-to-market strategy for our first commercial launch. We could go now to the slide deck, please. Starting with slide four. We're a global leader in allogeneic cellular medicines for inflammatory diseases and have established a leading position with intellectual capital with over 1,000 patents granted or filed across all the major jurisdictions. Slide five. Our platform technology demonstrates a shared mechanism of action across all of our products. The mesenchymal precursor and stromal cells that we are working with respond to and are activated by multiple inflammatory cytokines through surface receptors, resulting in orchestration of an anti-inflammatory cascade, all of which is central to the mechanism by which these cells turn off damaging inflammation in each of the diseases that we are aiming to get products approved for. Next slide please, slide six. US pattern exclusivity for these cells term compositions of matter and method of treatment patterns have been granted for RYONCIL as well as for our other stromal cell products out to at least 2037 and beyond in certain indications. Methods of treatment and manufacturing go out to as far as 2043, and they include mesenchymal…

Thank you Silviu. Please turn to the financial highlights for the year on slide 10. At June 30, our cash balance was US$63.3 million with an additional US$10 million from an existing facility on FDA approval of RYONCIL. We are pleased to report reductions in our net operating cash usage. There's a 23% reduction of $14.8 million for FY 2024 compared to FY '23 and our full year net operating cash usage was $48.5 million for FY 2024 compared to $63.3 million FY '23. And we recorded a 37% reduction of $6.1 million for Q4 in FY '24 compared to the prior comparative quarter. So our Q4 spend was down to $10.2 million compared to $16.3 million in the prior comparative quarter. These impressive reductions in cash usage were predominantly driven by reduced manufacturing activities and lowered payroll, which I'll explain in more detail on the next slide. We will continue our focus on prudent cash management for all operating activities as we undertake targeted commercial rollout and supply chain activities for remestemcel-L. Now turning to slide 11. We can report that we achieved the headcount and payroll cost containment targets we set for FY 2024, and I confirm that these initiatives will continue in FY 2025 as we continue our focus on cost control. Our 23% reduction in net operating cash burn in FY '24 was largely in part due to the successful execution of our payroll reduction strategy. The table below outlines the initiatives in more detail. So firstly, our CEO and CMO voluntarily reduced their base salaries by 30% in FY '24 and this reduction is also in place for FY 2025. They will receive non-cash LTIs in place of the base salary reductions. And additionally, management have also participated in that voluntary base salary reduction program…

Thanks Andrew. If we can go now to slide number 14. This is a snapshot of the clinical development programs for RYONCIL steroid refractory acute GVHD for children and adults. Slide 15. GVHD is a potentially fatal complication of an allogeneic bone marrow transplant. It's essentially a cytokine storm by the T-cells in the donor graft that attacked the gut, the liver and the skin of the recipient, seeing those tissues as foreign and the cytokines that are produced result in tissue destruction and ultimately death of the patient. Slide 16. The potential unmet need exists in 30,000 patients who undergo allogeneic bone marrow transplants globally, of whom about 20% are pediatric. In the US alone, about 10,000 patients undergo allogeneic bone marrow transplants. There continues to be a growing unmet need given that about 50% of patients will develop graft-versus-host disease. Next slide, slide 17. This slide updates on where we are with potential FDA approval of RYONCIL for pediatric patients with steroid refractory GVHD. We resubmitted our BLA for approval of RYONCIL on July 8 of this year, addressing the remaining CMC items in the August '23 complete response letter. FDA during this year had informed Mesoblast that the available clinical data from our Phase 3 study appears sufficient to support resubmission of the BLA. Hence, the BLA contains only items relating to the CMC that are that are new and responsive to the CRL. The FDA accepted the BLA resubmission within two weeks, considering it to be a complete response. We are in ongoing interactions and dialogue with the FDA in relation to the active BLA review. We anticipate a decision prior to or on the FDA's PDUFA goal date of January 7. Our strategy is to first gain pediatric approval for RYONCIL followed by label extension…

Thank you. [Operator Instructions] And today's first question comes from Louise Chen with Cantor. Please go ahead.

Hi. Good evening, everyone. This is Karby [ph] on for Louise from Cantor. Thank you for taking your questions. First, can you discuss any potential partnerships or collaboration that could accelerate your commercialization effort? And second, how are you planning on tackling reimbursement challenges, assuming you get approval for RYONCIL? Thank you so much.

Thank you. Well, so RYONCIL for pediatric and adult GVHD, we have a go-to-market strategy on our own, because we've already put a lot of effort into doing so. The patient population is relatively targeted and the transplant centers that perform these transplants are relatively small in number. So highly manageable commercialization process. We are in discussions with payers, and we have a very good sense of what the reimbursement is likely to be in this space, based on two important considerations. One is that the recent approvals of CAR T therapies, particularly in children with leukemia, we represent a similar population as the children we're targeting with GVHD, provides at least a level of basis for comparison. Secondly, we have five-year outcomes which we've talked to and have provided to the FDA last year. Five-year outcomes from our Phase 3 trial demonstrating a 50% overall survival for between four to five years, meaning that at least 50% of the children are cured of this disease. And that puts the treatment paradigm into the realm of genetic diseases, where again, intense therapy at the front end provides a substantial number of patients with curative outcomes. And so, when one thinks of reimbursement, given the orphan size of the population and given the precedence in both CAR T therapies and gene therapy, we think that the reimbursement is going to fall somewhere between those parameters. The second question I think you asked me was on partnering. And so, it really depends on which products we talk about. For our back pain product, we already have a commercialization partner in Europe, that's Grunenthal, which is Europe's number one pharmaceutical company in the pain space. The relationship with Grunenthal is robust. On successful completion of this Phase 3 trial, they will take on the responsibility of market access, pricing and distribution, and then we will be eligible for a variety of milestone payments. In the US, we will be seeking a similar relationship with a commercialization partner, leveraging the existing sales, marketing, distribution channels, rather than seeking to build those ourselves. And similarly with cardiovascular disease, we have now a pathway to potential approval, both on a first pediatric indication and secondly, the end stage heart disease indication. Those are fully manageable by us as a company, given the small patient populations. I think, in parallel, as we move the product through the FDA for potential approval in either of those two populations, we will be engaging with, and are engaging with currently potential commercialization partners who will take on the -- again, the potential commercial channels for the adult patients with class two to class four heart failure.

Awesome. Thank you so much and congrats on the progress.

Thank you.

Thank you. [Operator Instructions] Our next question today comes from Edward Tenthoff with Piper Sandler. Please go ahead.

Great. Thank you very much and congrats on all the update. I'm looking forward to the review for RYONCIL in acute GVHD. I'm wondering, when should we expect an update with respect to REVASCOR and kind of the regulatory filing plans. And how long do you think the Phase 3 for the spinal product will take? Thank you.

Sure. Let me take the spinal product question first. The Phase 3 now is up and running. You know how enrollment works, where you first of all recruit. A lot of the centers contract them, they start to screen their patients, et cetera, and you have a hockey stick kind of enrolment period. And so, we're in that early phase right now and we expect that it will ramp up over the coming three months or so. Our projection is that it'll take about 12 months to fully enroll, and then the primary endpoint is a 12-month outcome in terms of pain reduction. So, we will be updating the market as that program continues to move forward.

I'm sorry, Silviu. How many months to enroll? I apologize.

About 12 months.

Yep. Thanks.

With respect to the regulatory interactions on REVASCOR in cardiac disease, we have two potential early pathways to approvals. One is for the pediatric congenital heart disease and the other is for end stage patients on LVADs. The immediate plan for discussion with the agency in the second half of the year is going to be on the pediatric indication because we have a pediatric rare disease voucher designation. And it is important if you know that the first approval is the one that is linked to a pediatric voucher. So that is the fact that we need clarity with the FDA whether the randomized controlled trial that has already completed and that was the basis of the voucher designation can support a filing for approval process. After that discussion, we will be then also meeting with the agency, given the support they've given us, to an accelerated approval for the adults based on the totality of the LVAD study and the prior DREAM study. We will be meeting with them to understand exactly what clinical data needs to go into a filing for that patient population. The confirmatory study that will be required as part of any accelerated approval will be a confirmatory study of the DREAM population in ischemic heart failure, patients with class three, four heart failure. So that's a trial that is being designed as we speak and will be obviously presented to the FDA when we meet on a pre-BLA basis.

Excellent. Thank you.

Thank you. And this concludes our question-and-answer session. I'd like to turn the conference back over to Dr. Itescu for closing remarks. End of Q&A:

Great. Well, I'm very excited about the progress we've made in the last six months, and we look forward to maintaining the momentum and to updating the market in short order on FDA interactions and the potential approval of RYONSIL for our 1st commercial launch. Thank you everybody.

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