Mesoblast (NASDAQ:MESO) released full-year financial results and hosted an earnings call on Wednesday. Read the complete transcript below.
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View the webcast at https://webcast.openbriefing.com/msb-fyr-2026/
Summary
Mesoblast Limited reported net revenues of $115 million for FY2026, driven by the successful launch of Ryoncil, a first-in-class therapy for mesenchymal stromal cells.
The company is focusing on Ryoncil's label expansion beyond GVHD, targeting pediatric and adult markets, and expects continued double-digit revenue growth.
Mesoblast maintains a strong IP portfolio with over 1,100 patents, supporting a moat for its allogeneic cellular therapies and plans for future product expansions.
The company's second-generation platform, rexlemestrocel, targets major indications like chronic low back pain and heart failure, with potential markets exceeding $20 billion.
Financially, Mesoblast reduced its net loss by 44% to $57.5 million, with a strong balance sheet of $103 million in cash and reduced cash burn in the second half of FY2026.
Management highlighted strategic initiatives, including the ongoing Phase 3 trials for new indications and preparations for potential BLA filings in the coming years.
Full Transcript
OPERATOR
Hello and welcome to the Mesoblast financial results for the full year ended June 30, 2026. An announcement and presentation have been lodged with the ASX and are also available on the home and investor pages at www.mesoblast.com. At this time all participants are in 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 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 as of any subsequent date. The Company specifically disclaims any obligations to update such statements.
With that, I would now like to turn the call over to Dr. Silvio Otescu, Chief Executive of Mesoblast. Please go ahead.
Silvio Otescu, Chief Executive Officer
Thank you, operator. Good morning, good afternoon, and thank you all for joining us on Mesoblast's financial results and operational update for the period ended June 30, 2026. With me are our Chief Financial Officer, Jim O'Brien, Chief Commercial Officer, Marcelo Santoro, and our Head of the Orthopedic Musculoskeletal Program, Roger Brown. We could go to slide number two, please. Mesoblast is a leader in allogeneic cellular therapies. Ryoncil, our lead product for mesenchymal stromal cells, is the only FDA-approved product of its type, a first-in-class therapy, and has undergone a successful first-year launch with net revenues of $115 million for fiscal year 2026, first full year post launch. This is a highly profitable single product on a standalone basis, and the proceeds from revenues generated from this product are being reinvested in our Phase 3 programs and in our manufacturing for potential blockbuster opportunities. We've built a mature commercial capability with an infrastructure that supports product launch, growth, and beyond. Ryoncil label expansion beyond GVHD and other areas.
We've built a specialized sales team focused on hospitals, transplant centers, and specialists, and we've built a robust Phase 3 pipeline with multiple blockbuster opportunities including chronic low back pain that I'll be talking quite a bit on today, and inflammatory heart failure. Ryoncil label expansion beyond GVHD is focused on pediatric adults and children, rare inflammatory conditions such as Duchenne. Next slide, please. Our market leadership position is underpinned by our so-called moat.
We have a global IP portfolio of more than 1,100 patents and patent applications which provide commercial protection beyond 2044. Our dominant IP protects our cells, our manufacturing capabilities, and our multiple indications and commercial opportunities. We have a first-mover advantage in that Ryoncil is the first and only mesenchymal stromal cell product approved by the FDA. We're leveraging FDA guidance on how approved products such as Ryoncil can be expanded to obtain additional label or new indications.
We've completed multiple large US-based randomized clinical trials which continue to provide evidence of efficacy of our platform technologies. We are the leader in complex manufacturing with strong IP protection, significant know-how and advantages, and demonstrable FDA alignment, scale-up capability, and ability to leverage across our product pipelines. And finally, we're investing further in our next-generation technology to maintain our leadership position and enhance our tissue-homing characteristics and have new products that leverage our existing development to date.
Next slide, please. This slide is a snapshot of our worldwide leadership in allogeneic mesenchymal stromal cell using a portfolio that leverages two major platforms: rexlemestrocel platform in green and our remestemcel platform in blue. As you can see here, the remestemcel platform, branded Ryoncil, is obviously now in the market for children with this life-threatening disease called acute graft-versus-host disease, but it's also being expanded in adults in markets that are at least three times bigger than the pediatric market.
The total addressable market for the GVHD opportunity in children and adults is in excess of $1 billion. Remestemcel, or Ryoncil, is also being developed for other rare inflammatory conditions where the underlying mechanism of action can be leveraged beyond GVHD. One of these indications is Duchenne's. Duchenne is a very large unmet need in children as young as two to three years old, and these unfortunate children continue to develop inflammation of their muscles and muscle destruction and end organ damage involving the heart and lungs.
On the basis of preclinical data, plus leveraging the approval of Ryoncil and its mechanism of action, the FDA cleared an IND to commence a Phase 3 trial for potential registration of the product in this very large opportunity. The second-generation platform, rexlemestrocel, is based on using monoclonal antibodies to isolate an even more potent platform technology of stromal cells that are highly purified and demonstrated significant outcomes across multiple major indications.
This platform has been focused on local delivery in the heart, in inflammatory heart disease, and in the orthopedic applications, particularly intervertebral disc disease where a single injection into the disc space has resulted in substantial and durable long-term reduction in pain. The total addressable markets for rexlemestrocel just in cardiac disease and in back pain in aggregate exceed $20 billion. Huge blockbuster opportunities. Next slide, please.
Fiscal year 2026 proved to be a successful transition from the R&D company that Mesoblast was to a commercial company with delivery of major milestones. In our first full commercial year, we were successful in demonstrating a US launch of Ryoncil with fourth quarter net revenue of $36 million and annual revenue in first year in FY2026 of $115 million. Our gross profit on total sales excluding amortization expenses was $110 million. The major milestones that were achieved during the fiscal year were registration trial label extension of Ryoncil to adults with steroid-refractory acute graft-versus-host disease that has commenced and is currently enrolling across more than 40 sites in the United States; a successful IND submission with clearance by the FDA of our Phase 3 trial for pediatric Duchenne's; a completion of 350 patients treated in the pivotal randomized controlled Phase 3 trial for the blockbuster indication of chronic low back pain. This trial seeks to replicate an earlier trial which achieved more than 12 months reduction in pain from a single injection. The total patient numbers, importantly, in this trial increased from 300 patients to 350 patients as a result of strong demand from the trial investigators to have their patients enrolled in this innovative program for patients who otherwise have no alternatives. Now let's move to our financial update, which will be presented by our Chief Financial Officer, Jim O'Brien.
Jim O'Brien, Chief Financial Officer
Thank you, Silvio, and good day, everybody. On slide 8, our income statement for the year ended June 2026 as compared to June of 2025. Important to note here, as Silvio pointed out, we had $115 million of net revenue for the year. Very exciting year for us that we expect to build on in the future. We continue to invest in our R&D programs. Product development costs for the year were $17.3 million, and our continued R&D investment in our Phase 3 programs were roughly $21.2 million.
We did support the revenue growth of Ryoncil with the increased investment in sales and marketing expenses, roughly about $18 million. We're a very strong commercial team now built around the launch, and we continue to penetrate the market and grow market share. Importantly, we reduced our net loss after taxes this year by 44% to $57.5 million. Next slide, please. Our balance sheet remains very strong. We ended the fiscal year in June with $103 million.
For the year, net cash usage was $43.8 million. And importantly, in the second half of the fiscal year, our cash burn was $13.4 million compared to $50 million in the same period a year ago. We are working towards profitability. We have a very strong cash flow forecast, plus we're controlling costs on all areas across the businesses, and we're deploying funds where our operations are most needed to support operations and to continue to grow the company.
Our operating plan includes spending money on our Phase 3 programs, building out our manufacturing capabilities, supporting BLA filings, and having the appropriate inventory levels to support patient demand. Earlier this year, as we've reported, we entered into a credit line facility of $125 million, replacing a long-term debt that carries an 8% interest rate. There is no amortization of the principal for five years. Our balance sheet is very strong to support our upcoming fiscal year in terms of being able to deploy capital where we need to.
Next slide, please. And with that, I'd like to turn it over to Silvio again to take you through acute graft-versus-host disease programs and address the accomplishments that we've reached so far this year.
Silvio Otescu, Chief Executive Officer
Thanks, Jim. This next slide summarizes the key accomplishments so far for Ryoncil's commercialization in acute GVHD in children, importantly in green. The real-world experience continues to show the difference we're making in these children and their outcomes, with 84% survival early in the disease process with treatment of Ryoncil in children who otherwise would have a very high mortality. As I mentioned earlier, the net revenue exceeded $125 million since launch of last year.
We've now got more than 50 centers onboarded. And importantly, insurance coverage shows that more than 98% of U.S. lives across the country are now covered. Medicaid cover federally was in place early, mandatory in every state, and we were very pleased having received the J-code in October 2025, which continued to contribute to the growth in revenues. Finally, our focus in the next 12 months will be to expand product adoption in the adult market, and I'll talk about that in the next couple of slides.
Next slide please. So this is a snapshot of strategic approach to continued growth based on identifying and prioritizing those appropriate patients using various tools at our disposal, reinforcing the superior outcomes. Particularly, the earlier the product is used, the better the outcome in these very sick children. We will continue to access reimbursement pull-through and empower caregivers to demand that Ryoncil be used in their children as soon as the disease is diagnosed.
Next slide please. Now, the adult form of this disease is a huge opportunity for Ryoncil growth. There are more than 2,000 adults annually in the U.S. with steroid-refractory graft-versus-host disease and, of these, approximately 50% have grade 3-4 disease, which is associated with high mortality. Ruxolitinib is the only drug that's approved in the U.S. as second line for adults with acute GVHD. However, only about 42% of patients with the severe form of the disease, grade 3-4, actually achieve a response at day 28 to ruxolitinib, and these patients who don't respond have a very, very dismal survival, as low as 20% to 30% by day 100.
So there is a very large unmet need in adults who are currently being treated with ruxolitinib–refractory acute graft-versus-host disease. In these adults, mortality remains very high. Importantly, those are the very adults who have been enrolled under expanded IND under compassionate care by Mesoblast for treatment with Ryoncil. And unlike other therapies, which result in, as I said, survival of only 20% to 30%, we're seeing a 76% survival at day 100 in these patients with terrible outcomes.
Next slide please. This is a slide that provides a snapshot of, on the left-hand side, survival in patients who have failed ruxolitinib as second line and who are then being treated with other agents as third line. And on the right-hand side, patients who have failed ruxolitinib and other second-line agents have then been offered Ryoncil under our compassionate care program. What you can see here is on the left-hand side, the day 100 survival, where the dotted line is, is a dismal 20% to 30%, roughly 25% in this particular report.
Whereas on the right-hand side, patients who otherwise meet the exact same criteria have a 76% survival—adolescents and adults—when they've been treated for four to eight weeks with a regimen of Ryoncil. Therefore, we believe that this is a treatment that should be offered to these patients—a potential adult market of more than 600 patients annually with grade 3 to 4 disease, refractory to ruxolitinib or any other agents. Next slide please. But even more proximal than that is the entire second-line market in adults with acute graft-versus-host disease. As mentioned earlier, there are more than 2,000 adults annually who develop grade 3-4 disease as part of their disease process after a bone marrow transplant. This is a market that's three times bigger than the pediatric market. And this is a market that we have currently addressed through a randomized controlled trial of 180 patients actively enrolling across the U.S. These patients in this trial are being randomized one-to-one to ruxolitinib alone versus ruxolitinib plus Ryoncil. We are hoping to see a significant benefit in terms of a day 28 response and further benefit in overall survival. And if we're successful in this trial, Ryoncil would become part of the second-line treatment regimen in these high-risk patients with grade 3-4 disease. This trial is expected to take a total of 18 months to complete, but it will have an interim analysis when approximately 57% of patients are enrolled, or close to 100 patients.
And we expect that interim analysis to be performed in the fourth quarter of 2027. If successful, that would allow us to move forward with a BLA filing for a label extension. Next slide. Now let me move on to what we think is our largest and most exciting near-term blockbuster opportunity. That's our second-generation pipeline: rexlemestrocel for chronic low back pain. The unmet need is substantial. Of the 35 million patients across the U.S. who suffer from chronic low back pain, about 60% of the cause is degenerative—this disease, which is an inflammatory condition.
And of these, about 7 million fit into our criteria of moderate to severe disease within the first five years of diagnosis, refractory to all medical therapies, including opioids. The addressable market here is at least US$10 billion. Major milestones to commercial launch are a phase 3 trial that has completed treatment—all 350 patients have completed treatment. This phase 3 trial seeks to confirm an earlier phase 3 trial which showed pain reduction at 12 months.
This is an FDA approval endpoint as supported by various meetings and documents with the FDA. The trial readout is going to be in second half of calendar year ’27, followed by a BLA filing with potential approval in calendar year ’28. Next slide. This is a diagram that shows what the cause of this severe degenerative disease, back pain, is all about. On the left-hand side you see what a healthy intervertebral disc looks like. On the right-hand side, you see what a degenerative intervertebral disc looks like.
In the middle of that area in red, right in the middle of the intervertebral disc, is inflammation. That's where your immune cells come in to try to restore this integrity. But in the process of trying to repair, they release a cytokine storm—and many of you are familiar with that term from the COVID period—a cytokine storm that inadvertently destroys healthy parts of the disc. You lose disc height, and you have severe pain as your outcome. That's what we seek to address with a single injection of our cells right in the middle of that inflamed disc.
Next slide, please. What is the patient treatment journey in this disease? Well, after conservative treatments that include nonsteroidal anti-inflammatory drugs, there's very little after patients have failed for three months or more to conservative approaches. Many physicians still prescribe opioids. And unfortunately, opioids are very weak agents that reduce pain. They lead to continued requirement for progressively increasing dosing, there's addiction behavior that is associated with it, and unfortunately, accidental overdosing.
Beyond opioids, there really isn't anything else that can address the severe, unremitting chronic pain. And so many patients then move on to interventional approaches that are really surgically based, and that includes epidural injections that are guided by radiography, but also radiofrequency ablation, spinal cord stimulation, and intrathecal pumps. Beyond that, we are left with severe invasive surgery. So there is a large unmet market that we're targeting to treat moderate to severe chronic low back pain that is totally unaddressed at this point in time.
Next slide please. In the earlier phase 3 trial, this snapshot is taken from 202 patients who received a single injection, in blue, of rexlemestrocel, or, in red, rexlemestrocel combined with a carrier. What we see is that significant pain reduction was seen as early as six months, maximal by 12 months, and durable through at least 36 months, and in comparison to a saline injection in green, which shows very little effect. But just to put this into context, a very mild reduction in pain from a saline injection is about equivalent to what you would expect to see with opioids.
So this is a dramatic reduction in pain that is long-lasting from a single injection. And these are the data that we are aiming to replicate in the 350-patient pivotal trial that has just completed treatment. Next slide, please. Now, who are the physicians that administer this product? Today, the dominant caregiver that provides treatment to these patients are the pain specialists in multidisciplinary clinics, where a patient either goes directly or where the patient is referred from his primary care physician.
Next slide. When we've done a formal average commercial to various types of physicians, what you see in this middle panel that's circled, amongst the pain specialists—who are the experts in this space—85% of them, on reviewing the data from the earlier trial I just showed you, are more likely, on that basis of those results, to recommend rexlemestrocel for chronic low back pain than anything else if these results were to be replicated in a commercial product.
Next slide, please. Let me move on to our other blockbuster indication, which is chronic heart failure, also from a single injection with rexlemestrocel. We're targeting the sickest end-stage patients because that's where the biggest unmet need is today as we move forward in the broader indications. Despite an artificial heart, a left ventricular assist device, that is currently implanted in the left ventricle of these patients—who otherwise would have a 50% death rate in the first 12 months—the right side of the heart continues to be unprotected, continues to have inflammation, and continues to fail.
Right heart failure is the number one cause of death in these end-stage patients, despite the fact that they're being kept alive with an artificial heart in the left side of the heart. Next slide, please. And in registry data that cover more than 6,000 patients—this is very recent data in 2021 and continues to in 2026 be supported by registry data—the number one cause of both death and hospitalizations is right heart failure. You can see as many as 28% get right heart failure in these large registry studies.
And when you get right heart failure, you have backup of blood in your liver and your gut, and you have terrible bleeding. And so they die of multiple complications, including severe bleeding from the gastrointestinal tract. Next slide, please. Now, a randomized controlled trial was performed in conjunction with the investigators across the U.S. who perform these surgical procedures. And in that study, at both six and 12 months, a single injection of rexlemestrocel reduced by fivefold or more the incidence of major life-threatening gastrointestinal bleeding.
And this was due to strengthening of the right side of the heart and reduction in right-sided heart failure. Next slide, please. In addition to reducing bleeding, which was the principal efficacy endpoint in that trial, as you can see here in the top panel, we also reduced hospitalizations from right heart failure by about fourfold at 12 months in all patients, and particularly in those patients at highest risk, which were ischemic patients. And most importantly, as you can see in the panel below, survival was improved from a 30% mortality rate in these high-risk patients to about 9%, and this was significant.
Next slide. So our strategy is to file for full approval of Revascor in this high-risk patient population at risk of right heart failure and severe life-threatening bleeding. And if we're successful to gain FDA approval, then this approval can be extended into the much larger patient segment with class 2 and 3 heart failure, where there's approximately at least a million patients in the U.S. alone. Next slide. So in summary, the presentation today has told you what we've done, what we intend to do, and how we're going to do it in the next 12 months.
Ryoncil is commercial today, and we seek to have multiple label extensions for this product in order to strongly grow our revenue base. We seek to increase penetration of pediatric market, maximize early use, and position the product as both a third line and a second line treatment for adults with steroid-refractory graft-versus-host disease—markets that are more than three times bigger than the current pediatric market. Our focus beyond that is on additional inflammatory diseases, both in pediatric patients and in adult patients.
And the first that we're targeting is Duchenne's, which is a pediatric disease that's progressive without any cures today that begins as early as three to four years of age. In addition, we're pursuing strategic partnering opportunities for inflammatory conditions in both children and adults with various appropriate strategic partners. For our second-generation pipeline platform, rexlemestrocel, we've taken the program right to the end and retained full value in the U.S. market with a blockbuster indication of chronic low back pain. A pivotal phase 3 trial of 350 patients has completed treatment, and we are following these patients through 12 months, with the trial to complete mid-2027 calendar year. And then, if a positive readout, positions us for a BLA filing for blockbuster indication. A chronic heart failure program—we seek to complete our BLA filing with the FDA with the expectation that, if approved, that can be expanded into the much larger class 2-3 heart failure indication, which will be an opportunity for a strategic alliance.
On that note, I think I'll stop, and we would be delighted to take questions. Thank you.
OPERATOR
Thank you. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star two. If you're on a speakerphone, please pick up the handset to ask your question. Your first question comes from Edward Tenthoff with Piper Sandler.
Edward Tenthoff, Analyst at Piper Sandler
Great, thank you very much. And it's really exciting to see all the progress you guys are making. I have a question. I mean great growth from Ryoncil in the current label. Would you hazard a guess to what kind of growth we should be expecting over the next fiscal year? How far do you think we are in terms of penetration of the kids with steroid-refractory GVHD? And I guess my second question really came down to with so many different sort of pediatric inflammatory diseases and with the backdrop that DMD has been tough, you know there is some competition there.
Why did DMD come to the top of the list in terms of secondary indications for childhood inflammation? Thanks a ton guys.
Silvio Otescu, Chief Executive Officer
Sure. These are all great questions, Ted, thank you. I think with respect to guidance, I think we've only just completed our first year. The next 12 months will be, you know, we will assess it in due course. I know that Jim is very keen to review progress and by midyear we'll have a better sense of continued growth. But we certainly expect to see double-digit growth in the coming 12-month period. I think your question pertained also to our potential areas of growth in new inflammatory conditions.
Why Duchenne's is a great question. Duchenne is a complete unmet need. To your point, there are various people looking at how to use cell therapy in Duchenne's patients. Most of those people are looking at later-stage disease, 10 years and older, at a point in time when the children are already non-ambulatory. At that point we believe the disease is very late. That's not where we think we can make maximal difference in benefit. Maximal benefit we think should be obtained in children as early as age three or four, well before the age of nine, for example, when there is maximal inflammation by both T cells and macrophages in the muscles, in skeletal muscles and early on, even in the cardiac muscle. The mechanism of action of our cells with graft-versus-host disease lends itself extremely well to targeting the T-cell process that is going on in the skeletal muscle of these young children. If we can turn off that disease early, there won't be any need for products later on. Today there are a number of gene therapy approaches that aim to improve or bring back some of the normal dystrophin protein.
None of those are going to be curative and all of those will continue to be accompanied by severe T-cell–mediated inflammation of the skeletal muscles. So we think that we have a unique product built on the mechanism of action in GVHD. And we've demonstrated this in preclinical studies that is both likely to have a major impact early on in the disease and be additive to the gene therapies that are out there.
Edward Tenthoff, Analyst at Piper Sandler
That's very helpful. Thank you, Silvio.
Silvio Otescu, Chief Executive Officer
Thank you.
OPERATOR
Your next question comes from Olivia Saunders with Cantor. Hi.
Olivia Saunders, Analyst at Cantor
Thank you for the question. What can you guys tell us at this stage just around how enrollment is going in the adult GVHD study and for that interim analysis later next year. Is that alone enough for a potential sBLA filing or is there anything else the FDA has actually asked for as part of that adult submission? And then also just wanted to ask about powering for that trial design, if you guys have disclosed that and how you ultimately decided on a treatment effect on top of Jakafi, just in terms of effect size, really just trying to get a better sense for your overall confidence level around enrolling the right patients that will produce a high enough response rate to hit your stats goal.
Silvio Otescu, Chief Executive Officer
Yeah, these are great questions. Let me see if I can take those one at a time. The basis for starting this trial, and this trial has been recruited across more than 40 sites in the US, and it's performed in collaboration, in partnership with the Bone Marrow Transplant Clinical Trials Network, BMT CTN, which is a network of 80% of all the top bone marrow transplant centers across the US. So it's been validated by this group, which is an NIH-funded organization, which tells you where the unmet need is because they're driving this indication.
The unmet need is in patients with grade 3-4 disease who are currently being treated by the only approved drug, ruxolitinib. In that group of patients, which is about 50% of the adult GVHD market, ruxolitinib does not perform very well, has not demonstrated a survival benefit, with overall response rates in the 50% range. And so there is a big unmet need because these patients, if 50% of patients fail ruxolitinib, I showed you earlier, these patients have nothing else beyond that with a 25% survival at day 100.
Once they've failed ruxolitinib, that's where the big unmet need is. We're addressing this market in two different ways. I showed you data where Ryoncil, once ruxolitinib fails, can rescue these patients and get a 76% survival outcome. That's great. But it's a sequence that we and the physicians believe should be addressed even earlier. And so the trial design here is a trial in that group of patients, grade 3-4 disease, randomized 1 to 1 to ruxolitinib only, where we expect a 50% failure rate, versus ruxolitinib plus Ryoncil, where based on a single-center pilot study, we would expect to see an overall treatment benefit of at least 75% day-28 response. And so that's how the trial has been powered, with a powering approximately 85 to 90%. Your question was then—actually, I'm sorry, I believe the expectation is that it'll be about from 50% to about 70% overall response rate. Our interim analysis on 57 of patients is based on the assumption that we might do better than that actually and achieve a responder rate north of 75%. If we're successful and do achieve that, then 100 patients will be sufficient to declare success.
And so both of those, the full powering of 180 patients and the interim analysis to declare early success, have been vetted with the FDA. And both of those, if we overachieved at the early interim or if we achieved the expected outcome at the full study, both of those would support an sBLA filing.
Olivia Saunders, Analyst at Cantor
Okay, great. Thank you. And have you actually, are you able to disclose the percent or the number of patients that you've enrolled at this point? You're still feeling good about the interim?
Silvio Otescu, Chief Executive Officer
Patients have been enrolled, treated. We expect the sort of hockey stick effect as we enroll more by the end of this year. And then we expect to have a substantial number on a monthly accrual basis from January onwards, such that we will have achieved 100 patients roughly by the fourth quarter of next year. We're on track to do that.
Olivia Saunders, Analyst at Cantor
Great, thank you. Silvio,
OPERATOR
Your next question comes from Madeline Williams with Canaccord.
Madeline Williams, Analyst at Canaccord
Thanks for taking my question. Just as it relates to, just off the back of the expansion into the adult population, you know, you have mentioned that you've treated adults and adolescents and there's obviously been some good data that's come out as it relates to that. I mean, what have the conversations been with the FDA about your capacity to treat the latest-stage patients at an earlier time point and how feasible that might be.
Silvio Otescu, Chief Executive Officer
Yeah, as you can imagine, those discussions are very active. What I would say is that there's a new leadership at the FDA and we're very pleased with the new leadership, both at the level of the most senior leadership of the FDA, as well as at the CBER level, as well as the cell and gene therapy level. And there's been evident flexibility shown by the new leadership in other areas of cell and gene therapy. And we're in discussions and we will have meetings this quarter with the agency to discuss some of these new potential areas of label extensions.
Madeline Williams, Analyst at Canaccord
Thanks for that. And just as it relates to the timeline associated with DMD, you sort of touched on it, but do you sort of have any sort of clear plans to initiate the pivotal trial in that space in the next 12 months?
Silvio Otescu, Chief Executive Officer
We certainly do, absolutely. We at the moment are in discussions with a group of clinicians across the US to put in place what the appropriate sites need to be, and in discussions also with the stakeholders of the parents and children to ensure that we have the right groups that can recruit most rapidly and most efficiently. And as soon as all that's in place, this study is ready to begin.
Madeline Williams, Analyst at Canaccord
And just finally from me, I'll jump back in the queue—just for the next 12 months and sort of growing Ryoncil in the pediatric business. I mean, do you foresee that there'll need to be additional spend in that sort of core business to continue growing the revenue?
Jim O'Brien, Chief Financial Officer
Hey, Madeline, it's Jim O'Brien. Let me try to address that. I think we've got a good, clear line of sight in our spending on our important Phase 3 programs over the next 12 months. The capital allocation that we have and the plan to do so is crystal clear to us, and execution is of utmost importance in terms of achieving our milestones as we laid out today, as well as controlling costs and reducing our cash burn. So our—our plan for the new fiscal year is to be able to fund the programs that we've outlined today in a very judicious way.
Madeline Williams, Analyst at Canaccord
Great, thank you.
OPERATOR
Once again, if you wish to ask a question, please press star one on your telephone and wait for your name to be announced. Your next question comes from John Hester with Bell Potter.
John Hester, Analyst at Bell Potter
Good morning. Question for Jim. Jim, just looking at balance sheets, you've got cash of 103 million, net debt of about 15 million, and your cash burn in the second half, you said reduced to about 13 million. What is your expectation of the need to raise additional capital at this time?
Jim O'Brien, Chief Financial Officer
Well, I think we want to keep all of our options open. With that being said, my expectation is that our cash burn in fiscal 27 will be less than it is in fiscal 26, given the growth of the Ryoncil franchise and the market growth that we expect, cash receipts that we expect. Our budgets are very clear in terms of where we're allocating capital. So we'll keep our options open. But at this time our balance sheet is very supportive of us. Recall that our debt is all long term.
It's got a five-year balloon on it. So when I look at the cash balance that we have, our strong working capital, the company's balance sheet can support the growth that we've spoken about today. We'll always look to continue to invest in growth opportunities and be supportive of that from a financial standpoint and perhaps
John Hester, Analyst at Bell Potter
Just a follow-up. At what quarter do you expect to go cash flow positive from operations?
Jim O'Brien, Chief Financial Officer
Yeah, I'd rather steer away from that question at this point. It's early in our fiscal year and, as you know, when you talk about spending on R&D programs and enrollment, we're doing a number of projects around manufacturing processes. We are the leader in this space. Quarter-by-quarter fluctuations can happen, but we have a clear line of sight in terms of what our priorities are. And Silvio and I are guiding the company towards profitability for the next fiscal year and beyond.
So quarter by quarter, I think it's a little tough to pin me down on that. But I would expect to see in our future filings this year certainly a lower cash burn than we experienced in 2026.
John Hester, Analyst at Bell Potter
Okay, thanks.
OPERATOR
That brings us to the end of today's call. I'll now hand back to Silvio Otescu for closing remarks.
Silvio Otescu, Chief Executive Officer
Thank you everybody for joining us today and for the very insightful questions. We hope we've given you a very clear trajectory of the company. We've had a terrific year the last 12 months. We think the next 12 months are going to be even more exciting on multiple areas including growth of our revenue stream for RYONCIL and most excitedly about our back pain blockbuster opportunity. So we look forward to speaking with you all in the short term. Thank you everybody.
OPERATOR
That does conclude our conference for today. Thank you for participating. You may now disconnect. Goodbye.
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