2/26/2026

speaker
Operator
Conference Operator

Hello and welcome to the Mesoblast financial results for the half year ended December 31st, 2025. An announcement and presentation have been lodged for 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 in such forward-looking statements. In addition, any forward-looking statements represent the company's views only at 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 Paul Hughes.

speaker
Paul Hughes
Head of Corporate Finance and Investor Relations

Thank you. Welcome, everyone, to the Municipal House Financial Results Call, the period ending 31 December 2025. My name is Paul Hughes. I'm Head of Corporate Finance and Investor Relations. In the room with me today is our CEO, Silvio Tescu, our CFO, Jim O'Brien, and our CCO, Marcelo Santoro. We have a presentation to run through highlighting the financial results and the operations for the period, and then we'll have some time for questions at the end. So now I'll hand over to Silvio to begin.

speaker
Silvio Tescu
Chief Executive Officer

Okay, Paul. We can go to slide four, please. highlights the corporate priorities for 2026. We intend to continue to show strong growth in Rionsell sales driven by market adoption. We will build a strong cash flow with judicious use of funds for operations and an optimal capital structure. Cultural transition is critical so that we can move to an efficient commercial organisation. We will expand Rionsell label indications and obtain approval, seek to obtain approval for REC7's show cell products, our second-generation platform. Our manufacturing focus will seek to increase diversification, capacity, and cost efficiency for our platforms, and we will continue to focus on appropriate commercial partnering backed by demonstrable value drivers, including FDA approval, strong revenues, and advanced clinical programs. Next slide, please. This year was marked by a very successful product launch. We initially received FDA approval for Ryonsol in December 2024. Ryonsol is the first and only FDA-approved allogeneic mesenchymal stromal cell product. The product was launched in April of 2025 with revenues growing quarter on quarter. There is significant unmet need for continued update and increasing market adoption. And our net revenue from Ryonsol was $49 million in the first half of FY26. Next slide, please.

speaker
Paul Hughes
Head of Corporate Finance and Investor Relations

Thanks, Judy. Jim, we'll take you through the financial slides. Thanks, Jim.

speaker
Jim O'Brien
Chief Financial Officer

Thank you, Paul. Hi, everybody. I'd like to now review our first half fiscal 2026 operating results. And I should mention figures are in U.S. dollars. Total revenues for the period were $51.3 million driven by the successful launch of Ransom. Our net product revenues, as Silvio mentioned, were $49 million, and we had a gross margin of a strong 93%. Our R&D expenses for the period were $46.1 million compared to what we reported last year of $5.1 million. Now, last year's numbers were a bit skewed because we had a $23 million reversal of the inventory provision once we got approval of our onslaught. Without that adjustment, the prior year number would have been about 18.1 million. So, I'm sorry, we would have grown about 18.1 million over the prior year. And again, the spending in the period really related to our adult GVHD trials, back pain, and also our LVAC program, as well as getting ready for the BLA and some manufacturing work. Our sales and general administrative expenses were 28.5 million. compared to 18 million the prior year. And that increase really related to the sales and marketing effort that Marcella and the sales team did in terms of driving sales growth. The loss during the period this year was 40.2 million compared to 48 million in the prior year period. Again, as I mentioned a few moments ago, that prior year loss was impacted by the $23 million worth of reversal on inventory. And, you know, but for not those items, you know, we were down a year up about, we were down on a net loss about $30 million year over year. Just in terms of our operating spend and our cash flows, for the first fiscal quarter, first fiscal half of the year, excuse me, we were at $30.3 million. As we look to the second half of the year, we expect our operating cash flow uses to decline when compared to the first half of fiscal 26, based upon our projected cash receipts from revenues, as well as maintaining disciplined cost control measures and efficiencies in the operation. Then on the next slide, Just to point out our profitability and the growth pipeline from . As I mentioned, we had strong revenues for the period. Gross margin excluding amortization expense would have been about 44.2 million. Our direct selling costs were 7.7 million. And again, we have strong operating performance that allows us to invest in our R&D programs. and our lifecycle extensions, we do have a very robust pipeline. And we continue to invest in our manufacturing footprint as well as building inventory where needed and getting our second generation products to market. On page nine, next slide please, we had 130 million worth of cash at the end of December of this year. which you can also note that the reduction in our net spend over the year, as I said, will decline over the second half of this year. On December 30th of 2025, we entered into a $125 million non-dilutive credit line facility, the first tranche of which is $75 million was drawn at closing and enabled MesaVast to repay for its prior senior secured loan. We also partially repaid the subordinated royalty facility, which will continue to be reduced from ongoing revenue and will be fully repaid by the middle of 2026. The second tranche of $50 million is available to be drawn on our option through June of 2026. The new facility is a lower cost of capital for the company, freed up its major assets to provide flexibility for strategic partnerships and commercialization. In addition, the new facility can be repaid at any time without incurring early prepayment or make-all fees. It does not include any exit fees. It does not cover any of these last assets, which is a very strong point for the reason why we did this. This is terrific for the company. We have no restrictions on doing additional unsecured debt, or any licensing activities. We're very pleased with this line of credit and believe it will strengthen our balance sheet to support an exciting growth period for needs of less. On the next slide, looking ahead to the second half of 2026, we anticipate full-year buy-on-sell net revenues to range between $110 million and $120 million on a full-year basis. With that, I'll turn the call back to Silvio for additional comments.

speaker
Silvio Tescu
Chief Executive Officer

Thanks, Jim. If we can go to slide 12, I'd like to bring Marcelo Santora, Chief Commercial Officer.

speaker
Marcelo Santoro
Chief Commercial Officer

Thank you very much, Silvio. Next slide, please. So, good afternoon, good morning, everyone. We are extremely pleased with the performance of the launch today, and I couldn't be prouder of the work, the commitment, and the passion that our colleagues at Nistroblast demonstrates every single day towards these children. We have treated numerous patients since we launched, and we also is having a transformational impact in the treatment of these children according to this feedback we received from treatment centers and treatment teams. In fact, we're on track to achieve 20% market share by the end of year one in the market. The commercial performance today has been exceptional. This holds true not only against our initial expectations, but also when benchmarked against other successful rare disease launches. We have been later focused on building the infrastructure needed to ensure ReAnswer reaches its full potential. I am very happy to report that we have on board 49 treatment centers to date. In addition, ReAnswer is now listed on the formulary of 30 of those centers. a number that continues to grow steadily as more P&T committees review and approve its use. Formulary inclusion is critical, as you know, as it streamlines the adoption and use of Rheonsil when it's selected for a patient. Having this many formulary approvals in less than one year demonstrates the outstanding value of this product and the tireless commitment of the team to build the appropriate infrastructure for Spanish utilization. In addition, nursing hospitals have opted to use Optum Frontier, our specialty pharmacy partner, virtually eliminating their financial responsibilities with the product. On the payer side, we have also made exceptional progress. Riancio is now covered by insurance plans representing over 280 million lives across both commercial and government payers. Medicaid coverage is in place in all states, and our specific J codes for Riancio J3402 went into effect on October 1st, allowing for more efficient billing and reimbursement for both sides of care and payers, along with CMS published rates. Commercial payer support has also been very strong. All major payers, including Aetna, Cigna, United Healthcare, Anthem, Humana, and Prime Therapeutics covering all Blue Cross plans have issued favorable coverage policies for re-ops. Notably, these policies do not require step therapy, which simplifies patient access significantly. All of this has occurred within the first six months post-launch. Next slide, please. From a strategic approach standpoint, the RE-ONSO team is 100% focused on three key strategic pillars. The first is to proactively identify and prioritize appropriate patients who may benefit from RE-ONSO therapy. The second, to reinforce our superior patient outcomes in first-line treatment right after steroids. And the third is to empower caregivers to remain as we are also for their children. We have been working with several advocacy groups and will soon launch a comprehensive campaign dedicated to supporting both caregivers and patients. With that, let me turn back to Paul.

speaker
Paul Hughes
Head of Corporate Finance and Investor Relations

Thanks, Marcelo. I'll hand over to Silvio who's going to take us through the rest of the deck before we open it up to Q&A. Thank you.

speaker
Silvio Tescu
Chief Executive Officer

Thank you. We can move to slide 14. This slide summarizes our plans for label expansion of Rheonsil into adults. A pivotal study of Rheonsil as part of second-line treatment regimen in adults with severe cerebrofractory graftless host disease is underway with our partners at the NIH-funded bone marrow transplant clinical trials network. The basis for this trial is that 50% of adults who have severe GVHD fail existing second-line treatment, including predominantly ruxinib. These patients who fail have a 25% abysmal survival at 100 days. We have previously used Rionzol under expanded access in patients aged 12 and older, in many adults as well, 18 and older, who failed Rust Eliminate or other second-line agents, the use of that product in this patient population was associated with 76% survival at day 100, a remarkable result. As a result of these results, the final protocol design for the registration study in adults has been locked down and has been worked through with the FDA recently in a meeting with the FDA agency. We expect that following central institutional review board approval coming up in March, site initiation and patient enrollment will commence. Next slide, please. Further extension strategy for ONSIL is focused on various opportunities in pediatric and adult inflammatory diseases. The team is currently evaluating multiple indications to unlock value. including in the inflammatory bowel, neurodegenerative, and respiratory conditions. Our portfolio will be prioritized to maximize shareholder return by utilizing either internal investment strategies versus external partnership initiatives. Next slide. Slide 16. Now I'll be updating you on our second-generation platform, Rexlin EstroCell, currently being developed for discogenic chronic load back pain and chronic ischemic heart failure. Slide 17, our phase three chronic low back pain program. A first 404 patient randomized control phase three trial has already completed, and that included about 40% of patients who are opioid dependent. We met with the FDA recently and received positive feedback on potential filing of a BLA based on in achieving a clinically meaningful reduction in pain intensity at 12 months between the treatment arm and placebo arm. The robust results in opioid reduction from at least one adequate and well-controlled trial could be included, according to our meeting with the agency, as part of product labeling, which is a very, very, very important outcome. We, in fact, do already have an RMAT, regenerative medicine advanced therapy designation, or RETs let me show itself as a potential opioid-sparing therapy in chronic lower back pain. Next slide. The confirmatory phase three trial is recruiting currently 300 patients across 40 sites in the U.S. with a primary endpoint, 12-month reduction in pain. As I've mentioned, on multiple occasions, FDA has confirmed that that is an approvable endpoint. The enrollment of these 300 patients is expected to be completed in March or April. Data readout and VLA filing are expected in calendar year 2027. We have, at the same time, undergoing commercial manufacturing in order to leverage our existing capacity and cost efficiencies. I'll reinforce that there are many patients who are suffering from this terrible disease. Over 7 million patients across each of the US and EU5 due to general disease, patients who are otherwise run out of options other than a surgeon. This is a large unmet need for a potential blockbuster opportunity. Next slide, slide 19. Now I'd like to update you on Revascor, our product based on our platform that is being developed for chronic heart failure with reduced ejection fraction and persistent inflammation in either patients with class 2-3 heart failure or very end-stage heart failure patients who are being kept alive with a ventricular assist device in the left ventricle. We've got a slide 20. Elevating implantation improves overall survival in these end-stage patients, and that's well established. However, the underlying causes of heart failure in these patients, notably inflammation, persists. And while the left ventricle is improving the left side, the elevator is improving the left side of the heart, the right ventricular pump function remains vulnerable and continues to deteriorate. Therefore, progressive right heart failure continues to occur in up to 30% of patients and is the primary cause of multi-organ failure and death in this group of patients, mortality occurring within the first 12 months. In addition, life-threatening major mucosal bleeding due to progressive right heart failure and portal hypertension occurring in about 30% of patients, and is the major morbidity in this group, the main cause of recurrent hospitalization. Next slide. Now, we've performed two randomized controlled studies in this patient population. The more recent study was called LVAD Study 2, and that randomized 159 patients in a two-to-one randomization to provide primary evidence of Revascor's efficacy in reducing major bleeding events. A second study, LVAD study 1, an earlier study, is a supportive study for LVAD 2, randomized 30 patients in a two-to-one fashion, and provided supportive evidence also of Revascor's efficacy in reducing major bleeding events. Intramyocardial injections in both of these studies of either Revascor or Controlled were performed at the time of LVAD implantation. Importantly, both trials, both randomized controlled trials, showed that Revastor reduced cumulative incidence of major bleeding events, life-threatening GI bleeding, the trial's primary efficacy's insane at the end point, and related hospitalizations through six months. Both were significant. And then the next slide, slide 22. This provides you with some new data that we have not previously presented. This slide demonstrates the total number of major bleeding events resulting in hospitalizations over six months on the left-hand side and over 12 months compared to controls in the entire study LVAD2. As you can see, both on the left-hand side and panel B on the right-hand side, Revascal reduced major bleeding events and hospitalizations by about five-fold, a very significant reduction throughout a 12-month period compared to control treatment. Next slide, please. Now, moreover, particularly in the ischemic group of patients, what you can see is that on the left-hand side, in controls, In red, the ischemic controls had approximately a three- to four-fold increase in hospitalizations due to right heart failure. The non-ischemics had a very low incidence and risk of heart failure hospitalization. In contrast, on the right-hand side, by 12 months, you can see that the MPC treatments reduced the right heart failure hospitalization events in ischemic patients back to background levels, the same levels as are seen in non-ischemic controls. And again, those reductions of hospitalization from right heart failure were significant. Next slide, please. This slide focuses on the risk of death from right heart failure in controls on the left and in revascular treated patients on the right. As you can see in panel A on the left, amongst patient controls who had at least one hospitalization from right heart failure, the presence of, sorry, amongst controls, the presence of right heart failure hospitalization, at least one right heart failure hospitalization in red, was associated with a mortality risk and a hazard ratio of seven, or more than seven, compared to patients who did not have right heart failure. So in controls, particularly early, within the first four months after elevated implantation, the presence of a right heart failure hospitalization was a very strong predictor of death. In contrast, what you can see on the right-hand side, amongst revascular treatment patients, the risk of death, particularly in that early period, four-month period, is almost completely abolished. And you can see that the overall survival over a 12-month period in revascular-treated patients was the same irrespective of whether they'd had a right heart failure hospitalization or not. So what this means is that tremor and revascular not only reduces the incidence of hospitalization rates but protects these patients against death from right heart failure. Can you go to the next slide, please? So the summary of these new data, data that I haven't shown you here but we have also observed, is that The revascular reduces inflammatory cytokines and through inflammation reduction protects the at-risk right ventricle in these patients, the same right ventricle that continues to fail despite the fact that there's an L-gate in the left ventricle. The strengthened right ventricle reduces inflammation rates in the intensive care unit due to right heart failure and improves survival. The strengthened right ventricle decreases the risk of portal hypertension and therefore decreases GI bleeding events. This leads us to be very careful about how Revascor, beyond its potential use in patients with left heart failure problems, also has the potential to be used to improve right heart failure function in patients not only with ischemic heart disease, but other causes of right heart failure, including primary pulmonary hypertension and chronic lung diseases. Next slide, please. Slide 26. So let me give you an update on our CHF program, particularly our plans to file for approval. With these new data and our existing orphan drug designation for treating this group of high-risk patients with high mortality, as well as FDA's stated preference for randomized controlled trials, Nasoblast is moving from filing for an accelerated approval to filing for a full approval. Unlike an accelerated approval, Full approval does not require a confirmatory study. Aligned with FDA on items required for filing the BLA regarding CMC potency assays for product release and commercial manufacturing, we now have these activities well and truly underway, and we expect to file our BLA for full approval for this indication in the next quarter. Let me summarize our highlights and our upcoming milestones. We're also the first and only FDA-approved MSD product. It delivers net revenues of $49 million in the first half of FY26. As you heard, 49 centers have been onboarded. 64 centers account for 94% of the entire pediatric bone marrow transplant population, so we're well underway to achieve that in record time. We're initiating label expansion to adults, acute GVHD, a market that is three times larger than the pediatric market. We are currently prioritizing our portfolio, which includes the potential to go into the inflammatory bowel disease, neurodegenerative diseases, and respiratory conditions, and we will update the market as we focus on certain areas in priority over others. Our second generation of the Rexlin Estrocell is enrolling the second trial in back pain with full enrollment expected to complete by the end of March or end of April. BLA filing next quarter is in line for full approval for patients with right heart failure and end-stage heart failure with LVADs. And we're actively optimising manufacturing logistics to support commercialisation both of the Rexlim-Istrocell pipeline and obviously to have further inventory for the projected growth in Ransom sales. With $130 million in cash on hand as of December 31 and the new credit line that you heard about, which still has the potential for $50 million available to draw down, we're in a very strong financial position. And as you heard earlier, we are projecting a four-year fiscal 2026 where our net revenue to range between US$110 million and US$120 million. And I think I'll stop there and hopefully there are some questions that we can all address. Thank you.

speaker
Paul Hughes
Head of Corporate Finance and Investor Relations

Operator, if you could please open the lines for questions. Thank you.

speaker
Operator
Conference Operator

Thank you. If you wish to ask a question, please press star 1 on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star 2. If you are using a speakerphone, please pick up the handset to ask your question. Your first question comes from Edward Penthoff with Piper Sandler. This is Piper Sandler.

speaker
Edward Penthoff
Analyst, Piper Sandler

Great. Thank you very much, and congrats on all the great progress across the board. Could you just repeat the guidance you broke up a little bit for, 20 for this coming year?

speaker
Jim O'Brien
Chief Financial Officer

Yes. Yes. What we're projecting for the full fiscal year are net revenues ranging from 110 to 120 million, again, on a full year fiscal basis, 2026, ending June 2026. That's great.

speaker
Edward Penthoff
Analyst, Piper Sandler

Excellent. I'll get back in the queue.

speaker
Operator
Conference Operator

Your next question comes from Olivia Breyer with Cantor Fitzgerald.

speaker
Olivia Breyer
Analyst, Cantor Fitzgerald

Hi, guys. Thank you for the questions. I have a few, if you don't mind. Maybe just first on Rionsel in PEDS. You all mentioned potentially hitting 20% penetration of that pediatric population. I think it was by the end of your fiscal year, if I heard that correctly. So can you maybe just run through what those assumptions include to get to that 20%? And how high of penetration do you think you can realistically reach in this specifically PEDS population over time? And then I've got a couple more on your pipeline programs.

speaker
Marcelo Santoro
Chief Commercial Officer

Yeah, so thank you. So let me start with the second one and then go to the first, right? So the second one, we assume a 40% peak share. And you have to understand, we believe it should be 100%. This is a product that should be used by everyone. But let's be responsible and realistic. A 40% share is reasonable, right? So if you assume a range of patients, and obviously that's dynamic of 375 patients, that's what the 20% is based on. It's 20% until the end of our fiscal year. That's what we aim on achieving at that point.

speaker
Olivia Breyer
Analyst, Cantor Fitzgerald

And is that specifically for the fourth quarter of your fiscal year? Like if I'm kind of doing the math? Yes. Okay. Okay. That's helpful. Thank you. And then for your VASC or BLA next quarter, how is the FDA viewing the ischemic versus non-ischemic phenotypes? And have they given any input onto or around potential labeling language around the ischemic etiology or inflammation biomarkers?

speaker
Silvio Tescu
Chief Executive Officer

Well, so I think it's important to note that in the 159 patient trial, we achieved the principal endpoints of, in overall, in the full patient population without having to go to any subgroups in terms of the cumulative incidence of major bleeding events over the six months. Also, we achieved a significant reduction in hospitalizations from major bleeding events across the entire patient population without having to go to surgery. So our position is that we will be seeking a label for the entire patient population, especially given that the confirmatory study, LVAD1, also achieved the same endpoint across all patients. There's no question that the patients at greatest risk are those with ischemic etiology, and those patients have a higher level of inflammation. They have a higher risk for bleeding, right heart failure, and death. And interestingly, we saw the very same sort of thing in the larger trial in class 2-3 heart failure, where, again, we saw patients with ischemic heart disease, as an etiology, had high levels of inflammation, greater risk for 3-4 and MACE, and greater treatment benefits. So we will be providing the FDA with the totality of the data that confirms the support of trials, demonstration that are at greater risk, and treatment with our cells is even more effective in that subgroup, but we've achieved the endpoint around the pre-specified bleeding endpoint and hospitalization endpoint across the entire population. So that remains to be negotiated.

speaker
Olivia Breyer
Analyst, Cantor Fitzgerald

That's helpful. Understood. And then last question is just on the chronic back pain. Can you just clarify what data you're submitting to the FDA? Is it just a new analysis of the pre-existing data? And is your ongoing phase three not actually going to be part of that submission package? Maybe just some clarity around, you know, that update, because I do think that is a new disclosure.

speaker
Silvio Tescu
Chief Executive Officer

No, no, no. I didn't mean to say that we wouldn't be submitting the data from the new trial. The new trial, the second trial, which completes enrollment, by over the next month to six weeks in the plan to complete enrollment. That trial becomes the primary data set, and the previous trial becomes a supportive data set. That's certainly our intention. We have spoken with the FDA about looking at the subgroup of patients who are opioid dependent, and that's a discussion that is ongoing with the agency. But with respect to the primary endpoint in all comers, Of pain reduction, we will be using the two trials to present full data sets.

speaker
Olivia Breyer
Analyst, Cantor Fitzgerald

Okay. But that additional Phase 3 readout is coming in 2027, correct? So you're kicking off the filing before actually having that data?

speaker
Silvio Tescu
Chief Executive Officer

No. The objective is to complete that trial, get the readout, and move to a filing with Okay, okay, understood.

speaker
Operator
Conference Operator

Thank you. Your next question comes from Madeline Williams with Canacoid.

speaker
Madeline Williams
Analyst, Canacoid

Hi, team. Thanks for taking my question. Just in regards to coming back to the pediatric rayon tool and just the FY26 guidance, Can you speak a little bit to sort of, you know, how you're seeing repeat utilization amongst centers or just how that kind of shakes out over the remaining portion of the year and sort of just trying to dig into more?

speaker
Marcelo Santoro
Chief Commercial Officer

Yeah. No. I'd be happy to do that. Yeah. Yeah. So we see the continuous growth in the centers, continuous adoption, not only by more centers but also repeated use by the current centers we already have, which shows that they are finding utility in the products and repeating the treatment in all the children, right? So that's one component. The second component, we're also seeing very big, very large centers coming on board, which will substantially increase our confidence in this guidance. And, you know, it's a reality that's happening every day.

speaker
Silvio Tescu
Chief Executive Officer

And I would add to that that I think, you know, a major additional component is going forward is continued physician education. You know, we've shown both in our previous phase three trials and in the real-world data that the earlier this product is used, the greater the survival. And it's unquestionable. And so a lot of the effort by the team will be to educate physicians. You know, physicians have their own practice habits. And they all believe that their particular way of doing things is standard. Nothing is standard in this disease, especially given that only Rioncel is approved by FDA for treatment for rheumatism. So I think a major focus and an area of growth is to educate the majority to use the product as early as possible after steroids.

speaker
Marcelo Santoro
Chief Commercial Officer

Do you agree with that? For sure. And I would add one more, right? So as a father, You know, if unfortunately my child has something like this horrible disease, I would like to know the soft genes of it. So it's our obligation to empower them, to empower the caregivers, make sure that they understand that this product is available, and it's the only FDA-approved product, so that they can talk to their treatment teams and ask for this as a special therapeutic option for their children.

speaker
Madeline Williams
Analyst, Canacoid

Thank you. That's helpful. And just maybe one more from me, just in regards to Revascor and the full approval, filing for full approval rather than accelerated. I'm just interested, you know, you've obviously discussed the additional data, but I'm assuming there's sort of been some sort of constructive discussions with the FDA. And just sort of, you know, if you could provide more color about what your confidence is in receiving that full approval.

speaker
Silvio Tescu
Chief Executive Officer

Well, we've had multiple discussions with the agency. We We understand what they wanted to see and the data that I've highlighted to you today, particularly as it relates to mortality, is the number one area of focus. And the recent guidance by the agency to focus on randomized controlled trials rather than single-arm trials where major endpoints are being targeted like mortality give us a sort of perspective, particularly in an orphan disease indication where a single trial should be viewed as sufficient or approved.

speaker
Madeline Williams
Analyst, Canacoid

Got it. Thank you.

speaker
Operator
Conference Operator

Once again, if you wish to ask a question, please press star 1 on your telephone and wait for your name to be announced. Your next question comes from Michael Okonomich with Maxim Group.

speaker
Michael Okonomich
Analyst, Maxim Group

Hey, guys. Thank you so much for taking my questions today. Congrats on all the progress. I guess just to kick things off, there's obviously been a lot of changes at the FDA since you first launched the phase three in chronic lower back pain. So, I wanted to see if you've received confirmation from the current FDA administration that the 12-month pain-only endpoint is sufficient for approval.

speaker
Silvio Tescu
Chief Executive Officer

Yes, we have, absolutely. That's exactly why we had the meeting recently to gain confirmation from the current administration that that endpoint is an approvable endpoint, and that's exactly what we received. Moreover, the recent guidance from the FDA that a single well-conducted randomized controlled trial is sufficient for approvals in various indications also gives us great confidence that if we achieve that endpoint, this is an approvable trial, an approval endpoint.

speaker
Michael Okonomich
Analyst, Maxim Group

Thank you. And then just one more for me, and I'll hop back into the queue. I wanted to ask, when it comes to the upcoming filing in the class for heart failure programs, are there any outstanding items that FDA has requested that you need to finalize before you can submit that next quarter?

speaker
Silvio Tescu
Chief Executive Officer

Well, commercial manufacturing is always a very important component of this, and that is something that we are, you know, heavily engaged in. The product, Rexon-Extractor anti-spatial trials, was all made at Longa in the same facility where Rionso was made, which was approved for Rionso. And we believe that the vast majority of the manufacturing process is quite similar to the Rhinosil process. I think that will be an advantage in our farming, but that remains – we need to get some more confirmation from the agency. Nonetheless, we expect that the long history of manufactured product for back pain trials, cardiac trials will hold us in good stead.

speaker
Michael Okonomich
Analyst, Maxim Group

All right. That's great to hear. Lots to look forward to up ahead. Thank you so much for taking my questions today.

speaker
Operator
Conference Operator

That brings us to the end of today's call. I'll hand back to Paul Hughes.

speaker
Paul Hughes
Head of Corporate Finance and Investor Relations

Thank you. As you heard today, we're in a strong position with a number of significant milestones in this current second half of the period. We look forward to keeping you updated on the progress and the achievements. I'd like to thank everyone for their interest in moving by and participation in the call today. Thank you and have a great day.

speaker
Operator
Conference Operator

That does conclude our conference for today. Thank you for participating.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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