Thank you for standing by, and welcome to the Mesoblast Limited Operational Highlights and Financial Results for the period ended March 31, 2022 conference call. All participants are in a listen-only mode. There will be a presentation followed by a question and answer session. If you wish to ask a question, you will need to press the star key followed by the number one on your telephone keypad. I would now like to hand the conference over to Dr. Silviu Itescu, Chief Executive. Please go ahead.
Thank you very much. Good morning and good afternoon to everybody, Mesoblast's operational highlights and financial results for the period ending March 31, 2022. If we can go straight to slide number 4. Mesoblast has a platform technology with a well-characterized mechanism of action. Mesenchymal precursor or stromal cells respond to and are activated by multiple inflammatory cytokines through surface receptors that are well-defined, and which ultimately result in an orchestration of an anti-inflammatory cascade that controls the inciting stimulus in the first instance. Consequently, this mechanism of action applies to target the diseases of severe inflammation that are highlighted in our late stage portfolio of clinical assets.
If we go to the next slide 5, this summarizes the late stage clinical pipeline derived from our remestemcel stem cell platform technology in red and rexlemestrocel stromal cell platform technology in blue. Products derived from the remestemcel stem cell platform are in phase III for acute graft-versus-host disease in steroid refractory patients, acute respiratory distress syndrome, initially targeting COVID-19, and in earlier stage development for inflammatory bowel disease in patients with biologic refractory Crohn's and ulcerative colitis. Products derived from our rexlemestrocel stromal cell platform technology are being developed for disease or inflammation locally, chronic low back pain, and chronic heart failure. Now I'd like to introduce our Interim Chief Financial Officer, Andrew Chaponnel, who will take you through the financial results for the period ended March 31, 2022. Andrew?
Thanks, Silviu. Now turning to slide seven. Revenues in the quarter increased by 5% on the comparative quarter to $2 million and by 46% for the nine-month period to $8 million. Net cash usage reported for operating activities in the quarter was reduced by 40% or $10.3 million, down to $15.5 million compared with $25.8 million in the comparative quarter last year. For the quarter, net cash usage reported for operating activities when excluding inventory was reduced by 50%, down to $11.2 million from $22.2 million in the comparative quarter last year. For the nine-month period ended March 31, net cash usage reported for operating activities was reduced by 36% or $31.2 million and by 40% when excluding inventory.
Cash on hand at the end of the quarter was $76 million, and we also have up to an additional $40 million available to be drawn down from existing financing facilities subject to certain milestones. Turning to slide 8, you can see that our reported quarterly net operating cash burn has been significantly reduced over the last 5 quarters. Turning to slide 9, we can see the P&L result for the 3-month period. Within R&D expenditure, we saw a 34% reduction of $4.2 million as we reduced spend on clinical trial activities. We continue our steady investment in manufacturing, including production of remestemcel-L inventory to support the potential launch of GvHD. To date, we have manufactured $29.7 million worth of remestemcel-L inventory in anticipation of launch.
This pre-launch inventory will be recognized on the balance sheet if we receive FDA approval. Now I'll hand the call back to Silviu for the remainder of the presentation.
Thank you, Andrew. For the operational highlights, I'm joined by our Chief Medical Officer, Dr. Eric Rose. Let's focus on remestemcel-L for acute graft-versus-host disease. Slide 11. Acute graft-versus-host disease is a serious and often fatal complication of an allogeneic bone marrow transplant. It results from T-cells in the allogeneic donor graft attacking the gut, the liver, and other organs, the skin, as foreign. The end result is a cytokine storm that results in destruction of these major organs and frequently death. Next slide. Treatment options after steroids have failed are very limited in patients. In fact, no drugs are approved for children under the age of 12. In Japan, Mesoblast licensee, JCR Pharmaceuticals, has already received the only product approval for steroid-refractory GvHD globally in both children and adults. The burden of illness is significant.
50% of patients who receive an allogeneic bone marrow transplant will have acute graft-versus-host disease, and about 50% of these patients will be steroid refractory. In the steroid refractory population, mortality rates can be as high as 90% in the highest risk patient population. The market opportunity is substantial, with over 30,000 allogeneic transplants being performed globally and about 20% of these are pediatric. Can we go to slide 13? Data that has been accumulated for remestemcel-L in children with steroid-refractory GvHD is summarized on this slide, with efficacy and safety outcomes across a total of 309 children from three separate studies. As first-line therapy, remestemcel-L was used in a randomized controlled phase III trial of 260 patients, which included 27 children.
As you can see in yellow, in that particular study, remestemcel-L resulted in 28-day overall response of 64% and day 100 survival of 79%, compared with 38% response and 54% survival in the placebo-treated group. Subsequently, in a 241-patient study under an expanded access program, 80% of whom had grade C and D disease and had failed institutional standard of care, again, overall response with remestemcel-L was similar at 65%, and day 100 survival was 66%. Finally, when used as first-line therapy in an open-label phase III trial in 54 children with steroid-refractory GvHD, 89% of them had grade C/D disease. Again, remestemcel-L performed similarly with a 69% day 28 response and a 74% day 100 survival.
When compared against a control group contemporaneously treated with best available care, the so-called MAGIC cohort on the left of this table, you can see a significant benefit in terms of both day 28 response and day 100 survival. Can we go to the next slide 14? The MAGIC Algorithm Probability Biomarker score, or MAP score, with a threshold above 0.29 is a validated biomarker of disease severity. In fact, it's been shown to be a more predictive biomarker for mortality and non-response to treatment than a clinical criteria such as grading by Glucksberg or IBMTR grading.
You can see on this slide that patients with a MAP score above 0.29 in light blue across three different cohorts demonstrate substantially worse survival through 12 months than do patients with low MAP scores. In fact, survival levels of the order of somewhere between 10%-30%. Can we go to slide 15? In an investigator-initiated study at Mount Sinai, where investigators compared response and survival outcomes between children in the remestemcel phase III trial, GVHD-001, and MAGIC cohort children who were matched by biomarker severity using the MAP scores. As you can see here on the left is a significantly greater day 28 response amongst remestemcel children who had a MAP score above 0.29.
On the right, a significantly greater day 100 survival in remestemcel-treated children with a MAP score above 0.29 than best available therapy in the MAGIC cohorts. Both of those responses and survival were significant. 67% versus 10% for response and 64% versus 10% for survival. If we go to the next slide 16, this is a Kaplan-Meier analysis of overall survival through six months between remestemcel-treated children with high MAP scores in blue and best available therapy in children with high MAP scores in red. As you can see here, a very significant difference in overall survival through six months in children with greatest disease severity treated with remestemcel. Slide 17. Where are we with respect to our plan for BLA resubmission?
We believe that the proposed potency assay, which measures remestemcel-L's in vitro anti-inflammatory and immunomodulatory activity, helps establish a clear understanding of the product's mechanism of action in steroid-refractory GvHD and demonstrates the clinical relevance to the in vivo effect of the product in the 54-patient overall phase III trial in children with steroid-refractory GvHD. In fact, the strongest correlation between our potency assay and survival is seen in those very patients who have the highest mortality risk, as measured by both clinical severity or by high biomarker levels of inflammation, as I've just shown you, the MAP score. Additionally, we have now generated substantial new data from the expanded access program, EAP-275, in 241 children, which confirm the ability of the in vitro potency assay to measure product activity relevant to survival.
Our GMP contractor is now well-resourced, allowing final testing of product inventory for the BLA resubmission. Additionally, we've just completed last week, in preparation for the expected FDA review, a successful mock pre-approval inspection of the GMP manufacturing facility and our process, and this mock inspection comprised both on-site and virtual inspections by external auditors. Mesoblast will provide these new data to the FDA and address all CMC outstanding items as required for the planned BLA resubmission in the coming quarter. If the resubmission is accepted, CBER will consider the adequacy of the clinical data in the context of these CMC-related issues. Now let's move to remestemcel-L for acute respiratory distress syndrome, or ARDS, due to COVID-19. Slide 19. ARDS is caused by so-called cytokine storm in the lungs of patients infected with respiratory pathogens such as COVID-19 or influenza.
It's notable that new variants of COVID-19 continue to be emerging globally with higher than previous infection rates. Therefore, ARDS remains a major cause of mortality for COVID-19 patients who continue to be immunocompromised or are unvaccinated or have comorbidities, as well as, of course, ARDS continues to be a cause of mortality in patients with seasonal influenza and other pathogens. Remestemcel-L has the potential to tame the cytokine storm in ARDS and may offer a life-saving treatment for high-risk patients. We therefore intend to move forward with a pivotal trial for EUA with reference to the GVHD BLA product potency assay in place prior to trial commencement. Let me summarize some of the data that's been generated to date that supports our focus on the younger patient population.
Notably, those patients under the age of 65 continue to represent more than 50% of hospitalized patients from COVID-19. In our phase III trial, this is slide 20. In our phase III trial, which was halted after 222 patients. In a pre-specified analysis in patients by age, those under the age of 65, which accounted for the majority of patients, 123, in those patients, remestemcel-L significantly reduced mortality relative to controls with a hazard ratio of 0.53, as you can see here on the left-hand side, over 60 days of follow-up. The secondary endpoints of improvement in respiratory function, among other key secondary endpoints, showed trends that correlated with the improvement in survival at every time point tested on the right. If we go to the next slide, please, 21.
These mortality benefits and improvement in respiratory function were particularly evident in the exploratory subset of patients who were on dexamethasone. You can see on the left-hand side, in this 73-patient subset, the hazard ratio is 0.23, which is highly significant, indicating synergy between the two therapeutic agents. As you can see on the right, that synergy is evident also in the key secondary endpoints of respiratory function. Finally, if we go to slide 22, this synergistic effect on mortality, which is evident early on in the first 30-60 days, remains constant through 12 months of follow-up. In other words, those patients who are able to be kept alive early on ventilators and are able to be extubated subsequently do well over a 12-month period. Let's go to slide 23.
What is the regulatory pathway to potential EUA for COVID-19? The FDA has advised Mesoblast that one additional clinical study, if statistically positive, could provide a data set in conjunction with the data that has been completed in the 220-patient study, which might together be sufficient to support an EUA, Emergency Use Authorization. FDA provided guidance that the COVID ARDS file and future submissions for this indication may cross-reference manufacturing and potency assay information in the BLA for steroid-refractory GVHD.
We are working together with investigators from a clinical trial network, a major clinical trial network across the US that focuses on acute lung injury at over 40 sites across the US affiliated with Vanderbilt University to design and implement a pivotal trial for remestemcel-L to reduce mortality in the highest-risk patients with ARDS and as shown in combination with dexamethasone, the current standard of care in COVID patients. Let's move on to the third major indication for remestemcel-L, inflammatory bowel disease. Slide 25. Steroid biological refractory inflammatory bowel disease continues to be a substantial unmet need. In fact, more than 30% of patients who are on anti-TNF agents as first line are unresponsive and on an annual basis, more than 10% who initially responded will lose their response.
There is a continued growth and need for alternative treatments in the biologic-refractory patient population. In particular, what's needed is an agent that induces early remission in these patients with severe colitis in particular, where the alternative to the medical approach, unfortunately surgical, is surgical, which is highly unacceptable, particularly in young patients. If we go to slide 26, the company is working together with lead investigators at the Cleveland Clinic in an investigator-initiated study evaluating, in a randomized, controlled manner, a single endoscopic delivery of remestemcel-L into areas of inflammation due to ulcerative colitis or Crohn's colitis versus control injection. The study randomizes in a 2-to-1 fashion patients to receive a single intervention of the remestemcel-L or placebo.
Data from the initial cohort were recently published in the Journal of Crohn's and Colitis. The key results of the interim analysis, slide 27, the first 12 patients were as follows: All those with ulcerative colitis treated with remestemcel-L improved both clinically and by endoscopy scores within two weeks, and all achieved clinical endoscopic remission by six weeks. All Crohn's colitis patients treated with remestemcel-L showed remissions or responses by three months, as defined by endoscopy score, and by clinical score. In addition, remestemcel-L treatment resulted in a reduction of fecal calprotectin, a validated biomarker of disease activity, which was significant and indicative of remission. Whereas in controls with either ulcerative colitis or Crohn's colitis over a three-month period, endoscopy scores increased, fecal calprotectin levels increased, and clinical responses were not improved.
We expect that over the next few months, our lead investigators at the Cleveland Clinic will have more data to report as patients are recruited. Now let's move to our second platform technology, rexlemestrocel. The lead indication for this product is chronic inflammatory back pain due to degenerative disc disease. The potential paradigm here is outlined in slide 29. The burden of illness remains substantial, inflammatory back pain causes severe disability and inflicts substantial direct and indirect costs on the healthcare system. There are minimal treatment options for patients with inflammatory chronic low back pain after they've failed conservative therapy. Indeed, 50% of opioid prescriptions are for patients with chronic low back pain in the U.S., which is a major problem for, obviously, patients and for healthcare providers.
The market opportunity is huge with over 7 million patients across the US estimated to suffer from this degenerative condition, which is really an inflammatory condition. Similar patient populations are seen also in 5 major European geographies. Slide 30 shows the algorithm of the patient treatment journey. As I've said, after conservative treatments, which include non-steroidal anti-inflammatory drugs and a variety of other agents such as anticonvulsant therapy, the only alternative is opioid analgesics. Beyond that, interventional approaches such as spinal cord stimulation and intrathecal pumps. Ultimately, surgery is the last resort for these patients. There's a real need and an opportunity for our therapy, rexlemestrocel-L, to target moderate to severe discogenic back pain ahead of opioid analgesics and, of course, way ahead of interventional therapies.
Now, slide 31 goes to the mechanism by which inflammation results in severe inflammatory back pain. In the middle of the disc, stresses result in inflammation, cytokine release, ingrowth of nerves, and ultimately, both chronic pain and longer-term destruction and replacement of the damaged disc. That's what we're targeting with a single injection of rexlemestrocel-L. Slide 32 highlights some of the proposed mechanisms of action by which rexlemestrocel-L does two things. It appears to have a direct analgesic effect, and secondly, it directly reduces the inflammatory process that is the stimulus for severe pain. Now, the phase III outcomes in slide 33 are summarized here.
Overall, a single treatment of MPCs, a single injection of rexlemestrocel-L at 6 million cells plus hyaluronic acid as a carrier, resulted in significant and durable reductions in chronic low back pain through 36 months across the entire study. Greatest pain reduction was observed in those patients in a pre-specified analysis who had pain for less than the median duration of 68 months. Significantly greater pain reduction was seen in a pre-specified patient subset on opioids at baseline at all time points compared with saline controls. We're going to show you some of the data. On slide 34 is the overall analysis of change in pain across the 404-patient study.
As you can see here in red, patients who received a single injection of rexlemestrocel-L together with hyaluronic acid carrier demonstrated the greatest pain reduction, significantly greater than green, saline-treated patients in green at 12 months and at 24 months. If we move to slide 35, this is the analysis pre-specified in patients who had pain duration below the median for the entire study, which was 68 months. As you can see, the treatment effect is even greater, substantially greater, here relative to the placebo patients in green. We see very significant reductions in pain at every time point measured in those who received a single injection of rexlemestrocel-L plus the hyaluronic acid carrier.
The cells alone without carrier are indicated in blue, and they represent a reduction in pain midway between those who received the c-cells plus carrier versus the saline controls. Now, intriguingly on slide 36, despite the fact that patients and their physicians were told not to change medications during the entirety of the trial, by 36 months, 27% of patients who received a single injection of cells plus hyaluronic acid were able to fully come off opioids, and these are patients who had been on opioids at baseline, compared with only 7% in green of patients who'd received the saline injection. These results are highly encouraging and suggest that this treatment may result in an opioid-sparing outcome. What are the next steps for rexlemestrocel-L in chronic low back pain? Slide 37.
We met with the FDA Office of Tissues and Advanced Therapies several months ago, and they agreed with Mesoblast's proposal for using mean pain reduction at 12 months as the primary endpoint of the pivotal trial with mean functional improvement and reduction in opioid use as appropriate secondary endpoints. A key objective is to demonstrate durable reduction in pain and position rexlemestrocel-L as a potential opioid-sparing agent. The planned upcoming US trial will include sites also in the EU to support submissions to both FDA and EMA in support of our strategic partnership in Europe. Our discussions are active and ongoing right now with key investigators and our external advisors on the final protocol design before it goes to the FDA for review. Let's move on to slide 38. rexlemestrocel-L for the other major indication, which is chronic inflammatory heart failure in patients with reduced ejection fraction.
The mechanism of action here in slide 39 is complex. Progressive heart failure is a disease of inflammation caused by or associated with inflammatory immune cells, macrophages that secrete inflammatory cytokines. Our cells, as I've mentioned earlier, have receptors for these cytokines, and when placed in that inflammatory environment, are activated by the cytokines to release various factors that simultaneously turn off the inciting inflammatory stimulus and also induce a new blood vessel capillary formation that is critical for improving oxygenation and functional contractility in the myocytes in the heart. We believe that these are the mechanisms by which rexlemestrocel-L potentially improves clinical outcomes in these very sick patients.
Now, remembering that heart failure is a disease that has a mortality over 5 years that approaches 50% and has as an outcome that is as bad in terms of survival as many cancers. If we go to slide 40, the overall result using a composite endpoint of cardiovascular death, non-fatal MI or non-fatal stroke, the so-called three-point composite MACE, which was a post hoc endpoint comprising of pre-specified endpoints within the trial, demonstrated quite a striking reduction of 33% in those who received a single injection of rexlemestrocel-L relative to controls over a median period of 3 years of follow-up. Many patients were followed for as long as 5 years from a single injection and showed durable effects.
most importantly, if we look at slide 41, these effects were most pronounced in patients with ischemic or diabetic vascular disease. These patients account for over 70% of our phase III trial and are the major risk factor for poor outcomes, poor vascular outcomes in heart failure patients. As you can see here on the left-hand panel, 3-point MACE in ischemic or diabetic patients who account for 385 patients was reduced by about 37% with a single injection of rexlemestrocel-L. On the right-hand side, in those patients who had evidence of inflammation as measured by simple blood test CRP, the reduction in 3-point MACE in diabetics or ischemics improved, increased to 54%.
This is an extremely high reduction in ischemic MACE on top of maximal standard of care. It identifies inflammation as a biomarker that can be used to select for patients and enrich for patients who are most likely to respond to this therapy. Slide 42 summarizes the treatment effects of a single injection of rexlemestrocel-L, dark blue at the bottom of this table, as I've just shown you, overall in patients at high risk for adverse events, ischemics or diabetics, and overall in the patients with evidence of inflammation as measured by CRP, and compare that to the various studies that have looked at similar patient populations with risk reductions, not anywhere near the numbers that I've just shown you here, but of the order of anywhere between 6%-13%.
The 3-point MACE that we're talking about here is an acceptable endpoint for approval, has been used by the FDA to result in approvals of GLP-1 agonists for diabetic patient groups. Again, I must emphasize that in the study that we just completed, this reduction in MACE outcomes was on top of existing drugs that are used in this, in these high-risk patient populations. Where are we with this program? If we go to slide 43. Over a mean follow-up of 30 months, as I mentioned, a single injection of Revascor resulted in a significantly reduced composite of cardiovascular death or heart attack or stroke across the entire patient population, 537 patients. It was maximal in those with vascular disease, and it was even more enhanced in patients with evidence of systemic inflammation.
We've had several interactions with the FDA and have provided the full data set to the FDA and expect to receive guidance shortly on a potential approval pathway following the FDA's detailed review of the outcomes that I've just highlighted. I think on that note, I'll stop. Thank you very much for listening to us, and I think we're ready to take some questions.
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 are on a speakerphone, please pick up the handset to ask your question. Your first question comes from Louise Chen with Cantor. Please go ahead.
Hi. Congratulations on all the progress this quarter, and thanks for taking my questions here. First question I have for you is on the ARDS opportunity, are you looking for a path forward outside of COVID or is COVID your main priority right now for that opportunity? Secondly, on remestemcel-L, can you comment on how soon you could launch your product after an approval for acute graft-versus-host disease, and when do you expect a potential approval? Thank you.
Thank you, Louise. Those are great questions. Let's take the ARDS question first. It's quite clear that nobody really knows what the next 3-6 months are gonna hold across the U.S., with these new variants, highly infectious variants, mutations continue, and I think it's clear that even though severe disease has been reduced substantially by vaccines, large numbers of patients continue to be hospitalized and continue to be in ICU. Over 50% of patients are younger patients under the age of 65. We are clearly focused on addressing and confirming the data that we've seen in ongoing COVID-19 patients.
Having said that, there's obviously a continued unmet need for other pathogens, including influenza, which obviously is seasonal, but on an ongoing basis continues to represent a major problem with ARDS and high mortality, as well as pneumonias, bacterial pneumonias. We're in discussions with the most prominent network of physicians across the U.S. that focus on acute lung injury. We're working together to construct an appropriate pivotal trial design that first and foremost will target the younger ARDS population with COVID-19, but also will focus on other pathogens like influenza. We'll have a lot more to say about that in due course.
We think that we have an immunomodulatory treatment approach that is important not just for COVID, but beyond, well beyond COVID to other pathogens. The second question I think you asked was, are we prepared for a commercial launch? When do we think we will get approval for remestemcel-L for GVHD, and how are we approaching the commercial launch process? We're working on the assumption that after filing, there will be a period of somewhere between 2-6 months to gain approval. We're working under a priority review that exists today. We're working towards a Q1 launch next year.
To that end, our commercial leadership has put in place a commercial team, a strategic focus on pricing and reimbursement and outreach to the appropriate reimbursement folks that understands the data and the strength of the data. The commercial team is already in place. The footprint across the U.S., particularly for pediatric GvHD, is relatively small. 50% of transplants are done in you know around 12 transplant centers. We're able to address the patient population where they're relatively small, the targeted sales team. I think the intention is to build that out over the next year and with out.
Much is being learned from the insights gained from our partner in Japan, who over a three-year period since the product was launched, has penetrated about 30% of the addressable market in both children and adults. We will of course in a stepwise fashion expand from pediatric to adult with a view to a confirmatory study in adults, in high-risk adults to support the evidence of efficacy that we're seeing in children.
Thank you very much.
Thank you. Once again, if you wish to ask a question, please press star one. Your next question comes from John Hester with Bell Potter. Please go ahead.
Good morning, Silviu. Silviu, following up on that last question and your comment in relation to Japan. 30% market penetration after a few years, where is that sort of headed, and what do you think have been the barriers to sort of more full adoption in Japan?
I think the principal lessons from Japan have been the safety of the product and the rapid adoption and acceptance by physicians who are otherwise very conservative. The Japanese market is extremely conservative in general, but have adopted the product because of its evident activity in patients who are high risk and who don't respond to conventional therapies after they've failed steroids. I think that's become more and more evident in a real-world experience, and that I think has helped the rapid uptake of the product. I think pricing and reimbursement in Japan is obviously done in a very different way to the way it's done in the U.S. It's a bottom-up approach based on manufacturing, innovation, et cetera.
In the U.S., for a product that achieves the kind of survival benefits that I've outlined, in the highest-risk patient population where alternatives don't exist, then has its own value proposition. I think, you know, you need to look at the U.S. market in a very different way, where comparables might be CAR T therapies, for example, in similar patient populations. I think other than reimbursement, which is quite different, I think the adoption by the physician population, in Japan and the U.S. is quite similar. I think there's a lot to be learned there.
What does all that mean for U.S. adoption rates when once launched?
Well, for children, for example, assuming we get approval that there is no other therapy. We would expect that this product would be used in the majority of children relatively rapidly. You know, with the label that we're seeking is patients with grade B to D disease with severe clinical manifestations, which is the majority of children with steroid-refractory GvHD. We intend to initiate a confirmatory study in adults in similar high-risk populations. There, you know, the growth in the adult segment would depend, of course, on a positive confirmatory study. Should we be successful in adults with similar degrees of severity as in, as we've shown to be the case in children, we would probably bifurcate and target 50% of the adult market.
Those patients with the high-risk disease with very high mortality rates we would expect to be the preferred treatment for that patient population.
Okay. Perhaps just a question for Dr. Rose, who is on the call. Yeah, Dr. Rose, just a couple of comments perhaps in relation to the progress or the progression of the BLA resubmission and sort of what are you seeing there, and what level of involvement has Philip Krause had with that documentation as well?
Could you state the end of that question again?
Just any participation by-
John, maybe I could reframe the question to Eric. Eric, I think your experience with interactions with the FDA are key to our BLA filing and the recent appointment of Phil Krause to the board and his experience inside the Biologics Group. Maybe you could comment on how we are building our dossier and how you know you would lead the interactions and how you see Phil's input.
I think ultimately approval will be based on a totality of the evidence. As shown at the panel, the clinical data are quite convincing. The potency assay that we originally proposed had problems, and we've reverted to a new potency assay that speaks to the mechanism of action of the cells as an anti-T cell entity. We've also been able to demonstrate a clinical correlation between the potency assay and outcomes when measured by disease severity, measured by stage or by MAP score. We've overcome some supply chain issues that have been required to finish the potency assay for the inventory that we've already built for the commercial product that we're in the process now of validating.
Those three things, clinical effectiveness, potency assay and reagents to actually do the potency assay on our existing inventory, we think will carry the day. As a totality of the evidence, particularly for a patient group that's this sick and that has this high a mortality and this high a morbidity, we feel confident in the product.
Silviu, that's gonna be done this quarter I gather so.
Correct.
Presumably that will be a big day, the resubmission.
It's key that we do this right.
Yeah.
You can see that the pieces are coming in place, and it's critical that we do it right thoroughly and get it approved.
Okay. Thank you.
Thank you. There are no further questions at this time. I'll hand back to Dr. Itescu for closing remarks.
Terrific. Thank you everybody for joining us. It's been a very strong quarter for us. We're focusing very much on our BLA resubmission, which is critical for the company, and it's on the horizon and imminent. While at the same time maintaining a very strong control of our spend and our cash burn, and making sure that we continue to reduce our spend and be very judicious in how we execute our operational focus. Thank you, everybody.
That does conclude our conference for today. Thank you for participating. You may now disconnect.