Mesoblast Ltd (MESO) 2023 Q4 法說會逐字稿

Hello, and welcome to the Mesoblast financial results for the period ended June 30, 2023. An announcement and presentation have been lodged with the ASX and are also available on the Home and Investor pages at www.mesoblast.com. (Operator Instructions) 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 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 hand the call over to Dr. Silviu Itescu, Chief Executive of Mesoblast. Please go ahead.

Thank you, operator. Good afternoon, and good morning -- to our financial results and operational update for the year ended June 30. On the call with me today are our Chief Medical Officer, Dr. Eric Rose; our Interim Chief Financial Officer, Andrew Chaponnel; and one of our Board members, Dr. Philip Krause.

Today, we'll be talking about our regulatory interactions with the FDA. We will talk about our operational streamlining and our upcoming milestones as we progress our major Phase 3 programs and talk about our cost reduction strategies that we have implemented to ensure that we have significant cost containment and protection of our cash reserves.

We can now go to the slide deck, Slide 4, please. This slide is a snapshot of our late-stage clinical pipeline that is based on 2 cellular platforms based on stromal cells, remestemcel and rexlemestrocel. Remestemcel is being developed for both pediatric and adult graft versus host disease and other follow-on indications, including inflammatory bowel disease. I'll be talking about our pediatric GVHD regulatory filing and upcoming Type A meeting with the FDA shortly.

The program is also expanding into the much larger market, adult GVHD, which is 5x larger than the pediatric indication. Rexlemestrocel is being developed for chronic inflammatory lower back pain and inflammatory heart failure, and in both of those indications, has completed the first 2 pivotal Phase 3 programs. We'll be talking about those towards the end of the presentation.

Next slide, please. The investment highlights for the company. As I mentioned, we're developing products based on our novel allogeneic technology platforms that allows us to, through controlling manufacturing, develop scalable mesenchymal stromal cell products without the need for donor matching or immunosuppression that focus on the core mechanism of action around reduction of significant inflammatory diseases. The lead indication for remestemcel, our first-generation platform, is pediatric and adult steroid-refractory acute graft versus host disease.

We have developed substantial data that has been presented to the FDA. We will -- let me talk about those in a couple of minutes, but we do have a very important Type A meeting with the FDA mid-September -- scheduled for mid-September now to discuss our strategy for product approval.

For chronic low back pain, rexlemestrocel has completed a first Phase 3 trial. It has been granted regenerative medicine advanced therapy designation by the FDA. And we have alignment with the FDA on the primary endpoint of 12 months of pain reduction in a pivotal second Phase 3 trial, which is currently ongoing and underway.

We expect to have first patient recruitment in the next quarter. The program inflammatory heart disease, rexlemestrocel, also has completed the first Phase 3 trial in patients with reduced ejection fraction, has also completed a trial in patients with end-stage heart failure with an LVAD. In that indication, again, the FDA has granted the product RMAT designation, and we will seek to be meeting with the FDA to talk about extending the RMAT designation to patients prior to an LVAD.

Finally, the finances over the past 12 months. We've continued to have stable revenues from our royalties in Japan for TEMCELL from our partner in Japan. We have cash on hand of $71.3 million as of the end of the financial year, and we will have a lot more detail about cost containment strategies that have been implemented and have been put in place in order to preserve cash further.

Next slide, please, Slide 5 -- Slide 6. This slide summarizes the regulatory status for remestemcel in pediatric patients with GVHD and the upcoming Type A FDA meetings, which is now scheduled for mid-September. During the 6-month BLA review, we made substantial progress towards bringing this cutting-edge product to market with having completed a comprehensive FDA inspection of our manufacturing process and the facility where our cells are being manufactured. In August, unfortunately, the FDA provided a complete response to our BLA resubmission for the treatment of pediatric GVHD. The basis for this was a requirement that Mesoblast demonstrate that the product used in the Phase 3 trial, which was completed several years ago, is similar -- closely similar to the product that's intended now for commercial release as measured by a standardized potency assay.

We believe that we can link the product that was made in the Phase 3 trial to the current commercial release product through additional work using potency data. The FDA indicates that an additional trial would be needed to establish this link if the company is not able to do so via the additional potency assay work that is currently expected to be initiated.

The Type A meeting with the FDA is scheduled to be held in mid-September, and we will be laying out these exact strategies. We proposed providing FDA with additional potency assay data to provide the link between Phase 3 product and the current commercial inventory. We also proposed providing FDA with new clinical trial data in adults, which could also support pediatric indication.

Next slide. What are the new clinical data that we proposed generating? In line with our overall commercial strategy to progress to the adult indication, which is approximately 5-fold larger than the pediatric indication, we intend to conduct a targeted controlled study in adults with very high mortality risk. Survival in adults with steroid refractory GVHD, who failed at least 1 additional agent such as ruxolitinib remains as low as 20% to 30% by 100 days. In contrast, a 100-day survival has been shown to be 63% after remestemcel treatment is used under an expanded access in 71 patients aged 12 and older with steroid-refractory GVHD who failed to respond to at least 1 additional agent such as ruxolitinib.

We are in discussions with world-leading investigators at the Blood and Marrow Clinical Trials Network, the BM CTN, which is a prime body across the U.S., responsible for 80% of all U.S. bone marrow transplants. The discussion with this group is that they will conduct the new clinical trial. As a result, the costs of this targeted study are expected to be covered fully by the planned spending reductions that we will outline below in the financial section.

We can go now to Slide #8, which is our financial results section. Andrew, if you could take on the next few slides, please.

Thanks, Silviu. Please turn to the financial highlights for the year on Slide 9. Revenue from royalties were USD 7.5 million for the year. On a constant currency basis, royalties on sales of TEMCELL in Japan by our licensees were $8.1 million compared with $8.7 million for the prior year.

Net cash usage for operating activities for the year were $63.3 million. This represented a 37% reduction on FY 2021 and a 4% reduction on FY 2022. At June 30, 2023, cash on hand was USD 71.3 million, with up to an additional $40 million from our existing financing facilities subject to both certain milestones and the extension of availability.

Turning to Slide 10, please. There, you'll see we are reporting a reduction in expenditure and an improved loss before tax for the year ended June 2023. Our revenue of $7.5 million is predominantly from royalties on sales of TEMCELL in Japan. Our R&D expenditure was reduced by 17% from the prior year. Our R&D spend in the year was primarily to support the remestemcel-L, BLA resubmission and preparations for pivotal studies for rexlemestrocel. Our manufacturing expenditure reduced by 10% from the prior year and our finance costs for the year ended June 2023 include $15 million of non-cash accrued interest and borrowing costs.

Now turning to Slide 11. I'll take you through the cost containment plan for the next 12 months. Important to note that our net operating cash usage in FY 2023 was a 37% reduction compared with 2021 and 4% reduction compared with 2022. But we are targeting a further 23% reduction of approximately $15 million in our projected FY 2024 annual net operating cash spend through reduced spend across research, sales and marketing, commercial inventory and payroll. This targeted reduction will be partially offset as we invest in our Phase 3 programs for steroid refractory acute GVHD and CLBP.

We are targeting a 40% annual reduction in payroll by February 2024. This reduction is coming from reductions in base salaries, short-term incentive payments and contractor fees in the coming year. Our CEO and CMO have deferred their entire FY 2023 short-term incentives and have voluntarily reduced their base salaries for FY 2024 by 30% to preserve cash. Instead, they will receive long-term non-cash incentives to further align with shareholders. Any grants of equity based LTIs will be the shareholder approval.

FY 2023 short-term incentives have been entirely deferred for all employees. Management are eligible to receive LTIs in lieu of a 30% reduction in salary. And non-executive directors have voluntarily deferred 100% of the cash payment of their director fees and agreed to receive 50% of their fees in LTIs. Again, any grants of equity based LTIs will be subject to shareholder approval.

And for the coming year, we are shifting from quarterly to half yearly reporting of financial statements. The next financial statements we will report will be for the half year ended December 31, 2023. We will continue to report our quarterly cash burn by our Appendix 4C and include a report on operational activities. This process is in line with the requirements for ASX-listed entities.

Now, I'll hand the call back to Silviu for the remainder of the presentation.

Thanks, Andrew. If we go to Slide 13, please. This is a mechanistic slide, which I've addressed many times in the past. But I think just to summarize for those who don't know the disease, the devastating complication of a bone marrow transplant is acute graft versus host disease. It's mediated by the graft immune system attacking the gut and the liver, in particular, as well as the skin of the recipient and the immune cells create a cytokine storm that results in organ destruction and ultimately, death. What we aim to do with our mesenchymal stromal cell product is to target the precise mechanisms of the immune [disactivation] and turn off the immune cells and turn off the destructive cytokines.

Next slide, please, Slide 14. This slide addresses the market size and the opportunity for the company. There are more than 30,000 allogeneic bone marrow transplants performed globally and about 10,000 of those are performed annually in the United States. Whilst approximately 1,500 are in children, the remainder in adults, indicating that the adult GVHD market is about 5x the size of the pediatric market.

In Japan, we already have a product that is generating revenues for us. It's the only product that has been approved in Japan through our licensee, JCR Pharma. In the U.S., no products are approved for a graft -- steroid-refractory graft host disease in children. In adults, the only product that is approved is ruxolitinib.

Next slide, please, Slide 15. This slide is a summary of the short-term survival results across 3 distinct trials in pediatric GVHD with children having been treated for any stem cell. In each of these trials, you see short-term survival outcomes that are significantly higher than those survival outcomes at 3 and 6 months that have been reported in matched contemporaneous or historical control cohorts. These results have been extensively provided to the FDA as part of our BLA resubmissions.

Next slide, please. Slide 16 now shows the long-term survival outcomes of the children in our pivotal Phase 3 trial through to at least 4 years. And you can see that whilst 1 year survival was 63%, by 2, 3 and 4 years, survivals of the order of 50% and remain stable thereafter. In contrast, you see the results of 5 published contemporaneous studies in children and adults where survival at 1 and 2 years is abysmally low and substantially different from what we've seen in our Phase 3 trial. And there were no reports of survival outcomes in these high-risk patient populations beyond 2 years. These results also were provided to the FDA.

Next slide, please, Slide 17. We are now focusing in addition to the pediatric population on adults with steroid refractory GVHD. As I mentioned earlier, this is a much larger market opportunity. And the only drug that is approved in this patient population is ruxolitinib after steroid failure. However, 45% of ruxolitinib treated patients continue to be non-responders. And survival of these patients is 20% to 30% by 100 days, an abysmal outcome.

In contrast, across 71 patients under expanded access that have been treated with ruxolitinib patients who are 12 and older who are considered adolescent or adults and have failed to respond to at least 1 additional agent such as ruxolitinib, we have seen a 63% survival, a terrific outcome. And this is very similar to the type of survival that we see in similar high-risk pediatric patients.

As a result of these very promising data, we are in late-stage discussions with the Blood and Bone Marrow Clinical Trials Network across the U.S., body responsible for 80% of all U.S. bone marrow transplants to have them conduct the new clinical trial, which will target patients who have failed steroids in at least 1 additional agent such as ruxolitinib with a primary endpoint designed to either reduce -- to improve early day 28 responses or to demonstrate a survival benefit at 100 days. Importantly, the costs of this targeted study are expected to be entirely covered by the planned spending reductions as outlined earlier in the financial section.

Move to the next few slides, which focus on the opportunities with rexlemestrocel, our second-generation stromal cell allogeneic product.

Slide #19, please. The market opportunity for inflammatory low back pain is huge, both in the U.S. and in the dominant European markets. Over 7 million patients in each of these jurisdictions are estimated to suffer from chronic low back pain due to degenerative disc disease, which is an inflammatory condition.

And despite non-steroidal anti-inflammatory drugs or opioids, none of -- there are no other treatments that have an impact on either the disease symptoms or disease progression in this large patient population. In fact, 50% of opioid prescriptions in the United States are precisely for this indication and this represents a real major cause of the opioid epidemic that continues to be a major source of the healthcare -- poor healthcare outcomes.

Slide 20 provides a summary of where our program is at. We have regulatory alignment with the FDA on the appropriate pivotal Phase 3 study to confirm the results on the first Phase 3 trial, which showed a significant reduction in pain at 12 and 24 months follow-up. The Phase 3 protocol for this pivotal trial design has been agreed to with the FDA, had 12 months reduction in pain compared with placebo. Secondary endpoints are functional improvement and reduction in opioid usage. Product manufacturing has been completed for the trial and potency assays are in place for product release. The program has RMAT designation from the FDA, and the pivotal trial start-up activities have commenced and recruitment is expected to begin next quarter.

Let me just give you a snapshot of the data that underpin this pivotal trial and the regulatory interactions with the agency that resulted in the RMAT and the agreement on the pivotal trial and its endpoint. Slide 21, please. The results from the first trial showed that a single injection of rexlemestrocel delivered together with hyaluronic acid as a carrier into the lumbar disc resulted in significant reduction in pain compared with saline control at 12 to 24 and in fact 36 months across all subjects in the 404 patient study.

That pain reduction was seen in the subset of patients in addition who use opioids at baseline, and equals 168. So a very large subset, but the precise subset that is at gross risk of opioid overuse and addiction. Among patients on opioids at baseline despite instructions to maintain existing therapies throughout the trial by 3 years, 28% who'd received the cell product were not taking an opioid compared with just 8% of saline treated controls.

If you can go to Slide 22, please. This slide is a summary of the effect on pain through 36 months from a single intradiscal lumbar injection of our cells. And as you can see, the green line on this slide represents the mean change in pain at every time point after a saline placebo injection. In fact, the small reduction in pain that you see with saline approximates that is typically seen with opioid drugs so that even a saline rehydration of the disc has a small beneficial effect.

In contrast, if you look at the red line, the reduction in pain that's observed with a single injection of our cells together with the hyaluronic acid carrier gives a substantial reduction in pain that is maximal at 12 months and is durable for 36 months.

And that difference between the red and the green line is really the difference that we expect to see in the pivotal Phase 3 trial design in patients with -- who are within a 5-year period post initiation of pain. In other words, that early 5-year period when inflammation continues to be at its peak, the disease is still very much active and at a time point when we can have an impact, not on just pain but also in the natural history of the disease before the disc is ultimately destroyed by the inflammatory process.

Let's move to the last indication that I want to focus on, and that is our inflammatory heart failure program also with rexlemestrocel. Slide 24, please. This slide is a snapshot of the current program summary. The significant need is evident. Inflammatory low ejection fraction heart failure continues to be a very big unmet need with mortality that approaches 50% at 5 years.

The data that we've generated across 2 large programs is particularly promising, particularly in the DREAM heart failure Phase 3 trial, which was recently published in the premier journal in cardiovascular field, Journal of the American College of Cardiology, which demonstrated an improvement in ejection fraction at 12 months, preceding a long-term reduction in major adverse cardiovascular events defined by more cardiac mortality, heart attacks or strokes.

Potentially, the LVEF is an early surrogate endpoint for a reduction in these major adverse event outcomes. We believe that we have a good handle on the mechanism of action by which the cells impact both improvement in ejection fraction and improvement in MACE outcomes, and that's by reducing the active inflammatory process.

We expect to have a meeting with the agency that talks about both the data across the large 500-patient study, DREAM heart failure as well as the data that was previously generated under -- in LVAD patients for which the RMAT is already available. And the objective of the study is to show that similar mechanisms exist in the continuum of these 2 indications to allow us to have a larger RMAT umbrella that covers not just the LVAD patients but those patients with advanced disease prior to having an LVAD in place.

And Slide 25 really summarizes -- and I won't go into a lot of detail, but summarizing the continuum of this disease and where we think that our mesenchymal stromal cell product can have significant benefit, both in advanced heart failure as well as obviously those patients who are end stage and have an LVAD in place. This is the basis of the long-term program that we will be talking to with the agency and are also talking to with potential strategic partners.

Finally, Slide 26 provides just a pictorial snapshot on the right of some of the data that came out of the DREAM heart failure study. This shows just what an impact a single intramyocardial injection of our cells had on major adverse cardiac events in patients with inflammation. And as you can see here, almost an 80% reduction over a 5-year period in heart attacks and strokes, the major cardiac events that are affected in these patient population.

I think on that note, I might stop and open it up for questions. Thank you very much.

(Operator Instructions) Your first question comes from Louise Chen with Cantor.

So I wanted to ask you a few things. Firstly, will you give a public update after your FDA Type 2 meeting? And secondly, what's the expiration date on the inventory that you have on remestemcel that was ready to go? And then lastly, do you have any sense of what the cost and timing of your adult study will be?

Sure. So yes, we will be providing a detailed update post the Type A meeting to the market. Secondly, our inventory does not currently have an issue with expiration because as long as it's tested, we're able to demonstrate a shelf life that can be extended. I think our shelf life at the moment is up to at least 4 years, but it can be extended, providing the tests continue to be performed.

Thirdly, the question was the cost. We're projecting a relatively small targeted study in adults. The reason we're working with the bone marrow CTN network across the U.S. is that they have an established infrastructure in place.

And those are -- the relationship with them allows the CTN to conduct the trial in a manner that results in a very inexpensive clinical trial fraction of what a trial would normally cost with a commercial CRL. That's precisely why we are working with the CTN. They are developing the protocol together with us and are very excited to get this trial started.

In the patient population, frankly, that has no alternatives. The patient population is -- patients who failed a second -- have failed steroids and at least 1 other agent, which today is the only approved agent across the U.S. is ruxolitinib. There's about 45% of patients who were treated with ruxolitinib failed.

And those patients have nothing else that's approved or that works and the mortality rates survival in those patients is abysmally low at 20% to 30%. That's exactly the patient population where we have been treating with -- under expanded access. And we're seeing a 63% short-term survival benefit. That's the reason that the bone marrow CTN network is very excited to conduct this trial.

And from our point of view, we'll be providing product that we've already made. And the additional costs are relatively -- are very low relative to what a normal large study would cost and certainly will be picked up by the cost reductions that we've just outlined in terms of reduction in research and payroll and the like. So I hope that answers your questions.

Your next question comes from Edward Tenthoff with Piper Sandler.

Appreciate the update. Just digging a little bit more on that in the last (technical difficulty). How large do you think the adult trial might be? And will the 23% cost reduction be offset by the adult trial so the cost would be the same, or will the actual cost reduction just be a little bit less than the 23% that you mentioned?

The size of this trial is relatively small. And again, until we have full agreement with the agency. I need to be a little bit circumspect. But we're looking at per arm, something like 60 to 70 patients, something like that per arm. And the overall cost, given that we're working with the CTN, is going to be in the mid-single digits, that sort of thing.

So we're talking about relatively inexpensive trial costs. And so when you say how much will this offset our 23% cost reduction over the next 6 months? Very little will offset [the] good reduction. Yes. That led to sort of being fairly circumspect, but obviously, the detail of this will be -- I'll be able to talk to you in more detail after the Type A meeting.

So we kind of add that mid-single digit millions for the Phase 3 back on top of the 23% cost reduction when it begins. And then…

But remember, that's annualized and we're talking about the next 6 months in terms of costs. Yes.

Absolutely. And then a quick question just with respect to chronic lower back pain. I know you mentioned that you will start this trial next quarter, which is fiscal first quarter. How much will this cost? And how do you anticipate paying for this? Is that in the budget?

Again, the costs over the first 6 months are already in the budget. And again, this is a relatively inexpensive trial. It's a little bit more than the -- it's more expensive than a network-based study, but it's already well covered by our existing budget. Yes.

And then just 1 for Andrew, if I may. How long do you anticipate the cash flow (technical difficulty)?

The cost containment strategies that have been enacted will allow us to have sufficient cash through to the end of first calendar quarter at least next year. And our strategy to bring in more cash is 3 parallel strategies that we're currently acting and working through strategic partnerships in a number of areas. Remestemcel and rexlemestrocel, those strategic partnerships are active and ongoing in a number of areas.

Secondly, monetization of royalties, both real royalty monetization as well as synthetic royalty monetization. Those activities are active and ongoing. And thirdly, there's always the accessibility to capital markets.

The next question comes from Sami Corwin with William Blair.

I guess I was curious with the adult trial, if you thought about what the control arm might be? And then with regard to the chronic lower back pain trial, I just wanted to confirm that the FDA is okay with you proceeding with saline as the control arm?

Yes. Maybe I'll take the second question first. The FDA is perfectly happy with saline as a control arm. Absolutely. Yes. With respect to the GVHD program, one of the main reasons to be working with the CTN network is that they also have access to investigators that have large contemporaneous controlled patient populations that we can access and use potentially as control arms to our treated arms. Whether that will be the basis of the exact trial or whether we need to consider a randomization strategy is something that will continue to be discussed with the agency.

But we have various current strategies for what the appropriate control would be. Remembering that there are no approved drugs for the control patients and the controls whether they're randomized or contemporaneous will be on -- will be receiving best available therapy, which are unapproved drugs that target inflammatory pathways. And that today when used result in a 20% to 30% survival rate on with it.

And then just 1 more, if I may. I know you mentioned that in the extended access protocol and adults you've seen enhanced survival compared to patients treated with standard of care. But I -- if I recall correctly, the adults treated in Study 280 didn't achieve their primary endpoint. So I guess if you could kind of contrast the 2 studies, and what gives you increased confidence that heading into this adult study that it will achieve statistical significance?

That's a very, very good question. Study 280, which was performed about 10 years ago, was performed by Osiris using the product called Prochymal. That product was the first generation mesenchymal stem cell product manufactured using a different process. When Mesoblast acquired the product from Osiris, we made some manufacturing modifications, substantial modifications and the product with its improved manufacturing is called RYONCIL.

The RYONCIL product has demonstrated superior efficacy to the old Prochymal product in a range of pediatric studies. And now that we have data with RYONCIL in adults who failed steroids plus a second line, including ruxolitinib, the type of survival that we're seeing with RYONCIL, 63%, is very, very different than the old Prochymal achieved in trial 280.

So the potency of the product is a measure of its efficacy. And that potency is measured using the potency assays that are now in place and that have in part being shown to the FDA, although there's additional potency assay work that we're now undergoing that we intend to show further to the FDA. But those potency assays confirm the greater potency of RYONCIL and we believe are the basis for the explanation that [survival] benefits are greater with RYONCIL in both pediatric and adult populations than with the old Prochymal products.

The next question comes from John Hester with Bell Potter.

I want to refer back to your prepared comments there Silviu discussed about the -- your intention to provide additional data on potency to the FDA. It sounded to me like you're leaving the door open there with respect of the recent decision. I believe you said that you're hoping to show additional data to prove the potency of the current product relative to what was used -- the product that was used in the pediatric, say, from several years ago. Can you just confirm that, if I understood that correctly? And what exactly do you mean by those comments? And what do you hope to prove?

Well, that's exactly right. The primary reason for the CRL was that the FDA remains wanting to be convinced that the product in our current inventory that is to be used for commercial launch is substantially the same as the product that we used in the Phase 3 trial. And our potency assay needs to be substantially the same potency assay as was used in the Phase 3 trial in order to demonstrate that the 2 products are the same. And we have those data that are currently being developed. Some are in place, some still need to be added. We expect that in the next few months, we will complete those data. And that is part of the discussion with the upcoming Type A meeting. Perhaps Phil Krause could add some color to my comments.

Sure. I'll make a quick point here, and that is that the CRL had although, of course, the disappointment of being a CRL, but had 2 positive indicators in it as well, or 2 significant positive indicators. One, of course, was the favorable results of the inspection. But the other important thing to take note of is that the CRL did not question the efficacy of the product as was demonstrated in GVHD001 as had been the case in the previous CRL.

But the CRL did continue to question -- raise questions about the potency assay and specifically, the characterization and standardization of the product that went into GVHD001 and then, the ability then to make future product that was similar to that which went into GVHD001.

And so this leaves open the real possibility that by using exactly the same assays that were used to characterize the products going into GVHD001 for new commercial product, that it would be possible to show that the new commercial product is similar enough to that, which was shown to be effective in GVHD001.

Now the CRL then went on to say that if that can't be accomplished, in other words, this demonstration, then the only way forward would then be another clinical trial in either adults or pediatrics, which would then allow this connection between potency assay and clinical outcomes to be made and thus allow future product to be related to product that was shown to be effective in a clinical trial. So maybe I'll stop there, but I could take a follow-up if there is one.

Maybe just 1 follow-up, Mr. Krause, if I may. What were the -- what are the fundamental changes between the product that was used in the 001 trial and the product you were now attempting to have registered?

Yes. No, I can address that. There were no changes. The same exact manufacturing process and the same product went into the Phase 3 trial as is currently in inventory and intended for release. And that's really what the inspection of the process and the plant ultimately concluded. So there are no changes to the product. What we need to ensure is that we have a potency assay in place that was used precisely in that Phase 3 that continues to demonstrate the same attributes of the existing inventory.

Phil, would you add anything to that?

I would not. I think that's exactly right. The manufacturing assay has not changed.

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

Great. Thank you, everybody, for joining us today. We hope that we've been clear in providing details around our interactions with the FDA, our upcoming Type A meeting, our focus on finance and cost reductions, managing our cash runway and laying out the upcoming milestones on some of our most important products and where the value proposition is for our shareholders. Thank you very much.

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