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Stealth BioTherapeutics Corp (NASDAQ:MITO)
Q1 2020 Earnings Call
May 8, 2020, 8:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning and welcome to the Stealth BioTherapeutics Reports First Quarter 2020 Financial Results and Recent Business Highlights Call. My name is Sheryl and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference call is being recorded.

I will now turn the call over to Henry Hess. Sir, you may begin.

Henry Hess -- Chief Legal Counsel

Good morning. I'd like to remind listeners that management will be making forward-looking statements on today's call, including, for example, expected timeline and plans for development of elamipretide and other pipeline programs, and discussion related to the company's financial position and cash runway. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of Stealth BioTherapeutics Stealth's Form 20-F filed with the SEC on April 1, 2020. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so if our views change.

Now I'd like to turn over the call to Reenie McCarthy, CEO. Reenie?

Reenie McCarthy -- Chief Executive Officer

Thank you Henry and thanks to everyone for joining us this morning to review our first quarter 2020 financial results and recent business highlights. Joining me on today's call will be Rob Weiskopf, our Chief Financial Officer. Jim Carr, Chief Clinical Development Officer and Brian Blakey, our Chief Commercial Officer will also be available for Q&A.

Before we move into our clinical updates, I'll take a moment to discuss the COVID-19 pandemic and its impact on our business as well as our broader community as cases in the US, including in Massachusetts where we are based continue to rise. We have implemented business continuity procedures and safety protocols that align with guidance from public health authorities to keep our employees and their families, as well as our patients safe while maintaining the ongoing development of our product candidates and business operations. We have been working remotely full time since mid-March, grappling with the challenges of remote work environment, school shut down ongoing disruption to our sense of security and stability, along with the rest of our country.

Despite these trying circumstances, our deeply dedicated and highly committed team has rallied to successfully conduct our Type C meeting with the FDA for Barth, submit our request for our next Type C meeting, implement FDA guidance to protect patient safety during the current crisis in our ongoing Phase IIb ReCLAIM 2 clinical trial and Dry AMD, submit our intermediate expanded access protocol to facilitate access to therapy from Barth and other patients, continue our efforts with advocacy groups to expand our rare cardiomyopathy franchise and generally progress our business goals.

We are incredibly proud of our team and more broadly of our public health community of healthcare workers, government officials and essential employees who are serving and supporting our communities in ways they can during this extraordinarily difficult and unprecedented time. Moreover, while we have always been dedicated to our mission of improving the lives of patients suffering from diseases of mitochondrial dysfunction, this disease brings a new appreciation for the incredible challenges faced by immuno-compromised individuals and their families in the Barth and other rare disease communities, which we serve.

As we advised on our recent year-end earnings call, we expect COVID-related delays and enrollment of our Phase IIb trial and Dry AMD to push complete enrollments to year-end, due to the suspension of non-essential medical procedures and clinical trial site prioritization orders implemented by public health authorities. Since the trial is more than two-thirds enrolled already and some sites have now recommenced screening, it is possible that we may see an uptick uptick in enrollment sooner than expected, depending on how quickly other sites reopen. However, timing of all of these three openings remains unpredictable.

Our Phase 1 trial of SBT-272 is similarly delayed likely by a quarter. We remain committed to advancing these programs in addition to our ongoing open label Barth trial and we are working with our KOL clinical study sites and contract research organizations to continually monitor additional risks and find solutions to keep these programs on track to the best of our ability. We have sufficient quantities to complete our ongoing clinical studies and do not anticipate delays due to clinical trials due to manufacturing or supply chain related issues.

So we became aware of any further delays or interruptions will provide formal updates as appropriate. Notwithstanding the unprecedented impact of COVID-19, we made tremendous progress last quarter as I'll briefly recap of returning the podium over to Rob to discuss our financial results. We served several important clinical and regulatory updates on our Barth program during the first quarter. From a clinical perspective, we announced positive results from our SPIBA-001 natural history comparative control efficacy study, demonstrating that compared to natural history controlled patients receiving elamipretide for one year improves their six-minute walk test by more than 80 meters as well as improving their strength and their time to complete the five times sit-to-stand task.

We also presented data at the American College of Cardiology, ACC 2020 virtual meeting showcasing the effect of elamipretide therapy during open-label extension on key markers of cardiac function with significant improvement from baseline in the growth of change for left ventricular stroke volume and in left ventricular end diastolic and end systolic volumes as well as trends toward improvement in other echocardiographic parameters. Together, these data suggest that prolonged treatment with elamipretide may lead to cardiac reverse remodeling, strengthening our conviction in the potential of elamipretide to treat the cardiomyopathy symptoms of other rare metabolic diseases including Duchenne and Becker muscular dystrophies and Friedreich's Ataxia.

From a regulatory perspective, we announced a receipt of rare pediatric disease designation from the FDA. This renders us eligible for voucher upon FDA review and approval for priority review of another product candidate, which would obviously be a value to us either to utilize ourselves or to generate non-dilutive funds. We also had a productive meeting with the FDA's Division of rare disease and medical genetics at the end of March, during which the FDA requested additional data and information, including further analysis from our open-label extension trial and additional information on cardiac natural history of the disease. We have requested another type C meeting this summer to discuss this additional data, which we also hope to share at an upcoming scientific conference. We expect to provide further guidance on timeline to potential NDA submission following that meeting.

Based on these promising clinical signals in Barth as well as our prior experience in heart failure, we are actively discussing development plans for elamipretide in Duchenne muscular dystrophy and Friedreich's ataxia. We did submit our Phase 3 protocol for Leber's hereditary optic neuropathy at year-end. But as previously discussed, we do not plan to initiate that program this year given prioritization of other programs from the cash perspective. We also announced the initiation of our Phase 1 safety study for our next generation clinical stage compound SBT-272. Although we are experiencing some delays in dose escalation due to COVID, we are progressing our preclinical models and ALS and multiple system atrophy to inform our selection of our first Phase II patient population.

Also in our neurology pipeline, we're progressing preclinical candidates, SBT-259 and our new SBT-550 series, which targets the therapeutic pathway of cell death implicated in neurodegenerative diseases such as Parkinson's. We see significant promise for our mitochondrial targeted therapies to treat neurodegenerative disorders and we're eager to share additional updates regarding our preclinical initiatives later this year.

With that I will turn the call over to our CFO, Rob Weiskopf to review the financial results for the quarters. Rob?

Rob Weiskopf -- Chief Financial Officer

Thanks, Reenie. And thank you all for joining us today. Before we start, I would also like to acknowledge the phenomenal work of our employees during these unprecedented and challenging times.

Cash and cash equivalents were $31.2 million at March 31, 2020 compared to $50.8 million at December 31, 2019. Additionally, in April we secured $20 million in a private placement transaction with Morningside Venture Investments Limited with this financing as well as the strategic repositioning implemented early this year to refocus the company and reduce costs. We extended our cash runway to fund clinical and business operations into 2021.

R&D expenses were $9.8 million for the three months ended March 31, 2020 compared to $14.3 million for the same period in 2019. The decrease was primarily due to a $1.7 million decrease in employee and consultant costs offset by a net $0.5 million increase attributable to the strategic restructuring, a $1.5 million net increase in clinical costs due to the timing of trials, $1.3 million decrease in contract manufacturing, a $0.3 million decrease in discovery related expenses due to timing of activities and a $0.2 million decrease in regulatory costs.

G&A expenses were $5.2 million for the three months ended March 31, 2020 compared to $4.2 million for the same period in 2019. The increase in administrative expenses was attributable to a $0.8 million increase in professional fees and activities attributable to operating as a public company, a $0.7 million increase in employee and consultant related costs, primarily driven by share-based compensation expense and $0.4 million increase in employee costs attributable to our strategic restructuring. These increases were offset in part by a decrease of $0.9 million in pre-commercial activities, attributable to the strategic repositioning.

Other expense was $0.5 million for the three months ended March 31, 2020 compared to $24.7 million for the same period in 2019. The decrease in other expense is primarily attributed to a non-cash $22.7 million loss on extinguishment of debt associated with the conversion of convertible notes into ordinary shares in connection with our 2019 IPO. A $4 million decrease in interest expense related to the convertible debt is $0.3 million change in fair value of warrant liability. These decreases were offset in part by a $2.7 million change in fair value gain on the derivative liability associated with the convertible debt and a $0.1 million decrease in interest income.

Net loss for the three months ended March 31, 2020 was $15.5 million or $0.04 basic and diluted net loss per share as compared to $43.2 million or $0.20 basic and diluted net loss per share for the same period in 2019. The decreased loss was primarily attributed to the $22.7 million non-cash loss associated with the conversion of convertible notes in connection with our 2019 IPO, decreased operating cost of $3.5 million and a net decrease in other expenses of $1.5 million.

With that, I'll turn the call back to Reenie.

Reenie McCarthy -- Chief Executive Officer

Thank you, Rob. Before we open up for questions, I want to reiterate that the health and safety of our patients, our employees and our community is our top priority. As mentioned earlier, the ongoing pandemic has brought into sharp focus the risks that our immune compromised patients and their families face every single day, which only serve to strengthen our team's commitment to bring safe effective treatments to patients suffering from diseases involving mitochondrial dysfunction. This mission would not be achievable without the hard work of our team and the support of our shareholders. With their continued encouragement, we look forward to a promising albeit a challenging year ahead.

With that I'd like to open the line for questions.

Questions and Answers:

Operator

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Chris Marai. Your line is open.

Christopher Marai -- Christopher Marai -- Analyst

Yeah, hi. Good mornings. This is Chris Marai from Nomura Instinet. Thanks for taking the question, Reenie and congratulations on your progress. I was wondering, just based on a lot of investor interest, we're hearing, if you could perhaps elaborate on your ongoing FDA discussions with respect to Barth path forward and I understand you probably can't share a lot, but just in terms of their request your ability to meet their requests.

And then finally, maybe some scenarios that you see emerging from sort of these discussions. And then finally, I guess, when did you wrap-up and when should we see meeting minutes to give us a path forward here. Thank you very much.

Reenie McCarthy -- Chief Executive Officer

Great. Thanks so much, Chris. So we did have productive meeting with the FDA. This is Rare Disease and Medical Genetics division, which is really, it's a new division that was formed out of inborn errors of metabolism. This was our first face to face, actually ended up being by phone meeting with that division that we've had on the Barth program. So this is really the first time we had the opportunity to sit down and talk about all the data that we've amassed. The division was interested in seeing some additional analysis of the open label extension data including analysis out two week 72 of open-label extension and so that's something that we expect to provide and talk through with the division and hopefully at an upcoming Type C meeting.

The other area of keen interest for the division was a better understanding of the cardiac natural history of the disease. As you recall, we've seen improvements in stroke volume as well as systolic and diastolic volume in these patients, really suggestive of reverse cardiac remodeling. And in order to put those in context from an FDA perspective, I think there is -- believe that based on our conversations is a recognition that those types of echocardiographic parameters would not be subject to any kind of expectation bias, I mean we are talking about open label assessments, but FDA recognizes that those parameters would not be affected by bias. But it is important to really contextualize those in the overall course of the natural history for example with those changes be expected or would they not. So that's data that we were really hoping to be able to gather for the FDA and as it turns out, both through our SPIBA-001 protocol, which is the natural history dataset from John Tompkins, as well as some additional natural history data that we've been able to access.

We do believe we now have natural history data on what happens of cardiac volumes in Barth syndrome as part of the normal course of the disease that should help to throw essentially into relief the unexpected changes that we're seeing in our trial and the meaningfulness of those. So that's all really data that we hope to bring and talk to the FDA about this summer. We've previously talked about scenarios for this Barth program and I think we've talked about a best case, the base case and a worst-case and with the best case being full approval, a base case being accelerated approval under sub-part H, in which case the echo parameters would be quite important that surrogate endpoints potentially predictive of long-term clinical benefit and the worst case already communicated to us by originally in the division of neurology was the potential to look at a randomized withdrawal or collect some additional data. We don't think that randomized withdrawal makes sense given the structural changes that we're seeing in cardiac endpoints. We did not hear the division disagree with that during our meeting. They did ask us, whether there would be any potential to collect additional data from a pediatric trial or even in our ongoing expanded access program.

On the pediatric side quite frankly we've explained through the vision that wouldn't be possible, the age group that would be of interest there. There are less than 15 patients in the United States that would be eligible to participate in the trial and and obviously very challenging to enroll pediatric trials even when there are many more patients are not available. So all of that really brings us toward better educating the FDA about the cardiac natural disease and we have now collected the data. So we feel that we're in a good place to do that.

Christopher Marai -- Christopher Marai -- Analyst

Okay. And then just to maybe elaborate to -- you have moved your potential submission in your interactions with FDA to new division and so is there some level of the inborn areas of metabolism division sort of getting up to speed relative to your prior interaction maybe just maybe impacting the cadence of those interactions.

And then secondarily, I think you mentioned just clarify that cardiac natural history as well that is well established in terms of these Barth patients and [Indecipherable] declines or is expected to decline over-time and there is really no expectation for sort of improved net oral stabilization [Indecipherable]. Thank you.

Reenie McCarthy -- Chief Executive Officer

Sure. And so I'll take the questions in order. And I'm going to ask Jim to weigh in on the last part of that. So in term of our interactions in the cadence of the interactions with the division, this has been a little bit of a roller coaster, but actually we do think that we've got a very good dynamic with the current staff but the general rare disease and medical genetics. So we started in the division of neurology last spring, we moved to inborn errors and we had a written response meeting with them over the fall. Inborn Errors has really been rechristened rare disease in medical genetics division. So some of the folks who are interacting with in written interactions over the fall are now in the newly christened rare disease and Medical Genetics division including the Assistant Director somebody who we've not only interacted with in our prior correspondence, we've interacted with her around our expanded access program and we've actually met with her at the PM at the mitochondrial disease workshop at the FDA-sponsored last fall.

So we definitely think that the cadence and the interaction and the responsiveness is all there with the FDA. In fact the FDA was encouraging us to come back and have further dialog with you know really acknowledge the benefit the patients seem to be deriving from the therapy and just really encouraged us to continue this dialog and further meetings, which is again why we submitted the types C request for another meeting.

In terms of the cardiac natural history that actually is not that well established in Barth and what is established in Barth is the fact that 90% of patients have cardiomyopathy and it is by far the leading cause of death in that disease. And as you know, really there is nobody that there's maybe one or two patients that have ever survived into their 50s. So this is a life limiting disease, but the why of it isn't super well established and particularly when you focus on cardiac volume.

And so with that, maybe I'll ask Jim to comment a little bit on what we've seen versus what we are now covering from these natural history cohorts that we've been able to access. Jim?

Jim Carr -- Chief Clinical Development Officer

Sure. Really happy to comment about this. So Chris, as I think you know we've observed improvements in stroke volume. So during each contraction there is relatively more blood being expelled during a stroke and what we've observed in natural history is that this is an unexpected findings, so that is not expected to increase naturally. So based on our observations in two different databases as Reenie mentioned there's database from Johns Hopkins, which was part of our 001 protocol. But we have accessed additional data external data that allows us to benchmark our data. So again, the improvement in heart function that we are observing is not expected naturally.

The why of that or why is that important. So in the setting of heart failure due to reduced ejection fraction, for example, ejection fraction is followed very closely and it's a marker of clinical decline. So, yeah, that raises and tenants about whether or not there is decompensation earnings, stroke volume is simply part of the ejection fraction equation. Yeah, ejection fraction is to client divided by diastolic volume. So we're seeing a measure of cardiac performance, but I think can be associated with the ejection fraction. So what we're seeing is an improvement of cardiac performance, which is not expected naturally and we think that is important because we think that that can relate to essentially longevity of the patient and if we're maintaining cardiac performance if that makes sense.

Christopher Marai -- Christopher Marai -- Analyst

Okay. It does. And if I may just ask with respect to the [Indecipherable], do you have some clear ideas about the mechanism directly impacting the heart or is this potentially that patients have more energy and they have a higher level of physical activity in that higher level of activity may be have a positive benefit on their cardiac function or is that sort of, it's not possible. Thank you.

Reenie McCarthy -- Chief Executive Officer

Jim?

Jim Carr -- Chief Clinical Development Officer

Sure. So I think it's the last part of isolated, Chris, I think it's the opposite. We're actually observing an increase in correlation with cardiac performance and functional capacity. So I think it's actually and this is recognized in the setting of hypertrophic cardiomyopathy that particularly during exercise that improvement in diastolic volume for example is important. So I think what is contributing to the improvement in some of the functional findings that we're seeing is an improvement in cardiac performance and it's, again, we're seeing increasingly apparent trend on that finding that is stroke claims is more strongly correlating that week 72 with the performance of six-minute walk test, for example.

And I'm sorry I missed out on the

Reenie McCarthy -- Chief Executive Officer

Mechanistically.

Christopher Marai -- Christopher Marai -- Analyst

That's right, yes.

Jim Carr -- Chief Clinical Development Officer

So mechanistically no doubt, the Energetics may be improving relaxation which I think would be detected in the volumes and diastolic volume for example. But I think long term what we've seen is that these -- the impact on the heart of the favorable impact seems to have some time dependencies of the about of the outcome. So it's been observed in the heart failure, reducing oxidative stress and have long-term benefits. So perhaps, it's the reduction in reactive actions species that are playing a role just the fact that there is some metabolic homeostasis for the curves, which is why we think the heart type in the first place. It's better able to support to feed the heart glucose which is adaptive change so perhaps it's just restoring some of the metabolic balance. So of course some of this is speculative. But based on what we know about the mechanism, it is somewhat intuitive that a longer duration of treatment would confer more benefits and that's in keeping with essentially a reduction oxidative stress.

Christopher Marai -- Christopher Marai -- Analyst

Great, thank you.

Reenie McCarthy -- Chief Executive Officer

Thanks, Chris.

Operator

Our next question comes from Yasmeen Rahimi with ROTH Capital. Please go ahead.

Paul O'Brian -- ROTH Capital Partners -- Analyst

Hi team Paul on for Yasmeen. Congrats on the progress and hope you are safe and sound during these challenging times. We've two questions this morning. First, with the progress made in the US, can you walk us through the path forward for elamipretide in part in the EU and share with us any progress so far?

And second, can you just walk us through your framework for evaluating elamipretide in muscular dystrophies such as Duchenne and Becker's and how that cardiomyopathy benefit could translate. Thanks again for taking the questions.

Reenie McCarthy -- Chief Executive Officer

Sure, absolutely. So I'll ask Brian to speak a little bit further to our thoughts on the EU and we do think that Barth being an ultra-rare disease and there are patients suffering from that in the EU, that would be a market that we would certainly explore. Our topline thoughts are really to turn to the EU after we have US approval.

Brian, anything to add there.

Brian Blakey -- Chief Business Officer

No, I think the way we're looking at both an EAP expanded access program, something that we could maybe get reimbursement from, but also looking at the potential for partnerships as well and we're exploring that now.

Reenie McCarthy -- Chief Executive Officer

Yeah. And then in terms of our evaluation in Duchenne and Becker's muscular dystrophy, there have been some -- there have been some examples preclinically certainly in explanted tissue heart tissue from Becker patients where we see an improvement in mitochondrial function with elamipretide, but more broadly what we're doing there is meeting extensively with advocacy groups as well as convening an Advisory Board of top key opinion leaders in the cardiac space and in those disease areas specifically and we're convening that over the next couple of months. Jim's been working extensively on that. To really neat and threshold potential protocol design, we would expect to go into the FDA with that design.

And so and I'll ask Jim to comment on and expand on this, but one of the things that we think is really important and what we see in the Barth data and particularly to the extent where we're seeing potential surrogate endpoint such as stroke volume is really laying the foundation for broader cardiomyopathy franchise to get some alignment with the agency around the potential for this endpoint to service surrogates which we then think could also be informative as we expand out into these essentially larger populations, Duchenne and Becker.

Jim, anything I miss there?

Jim Carr -- Chief Clinical Development Officer

No. I think you captured it eloquently Reenie.

Reenie McCarthy -- Chief Executive Officer

Great, thanks. Thanks, Paul.

Paul O'Brian -- ROTH Capital Partners -- Analyst

Thanks again.

Operator

Thank you. Our next question comes from Matthew Luchini with BMO Capital. Please go ahead.

Noss -- BMO Capital -- Analyst

Hi Reenie, this is Noss [Phonetic] on for Matt. Thanks for taking the questions. I have a question on dry AMD. It seems like the timeline for enrollment has now being pushed to year-end 2020. Can you just walk us through your assumptions around the COVID-19 impact. What are you seeing that is pushing the timeline now into year-end 2020. What needs to happen to fully complete enrollment by year-end 2020 and perhaps get data out in, is it fair to assume you're on '21. Thank you.

Reenie McCarthy -- Chief Executive Officer

Sure. Thanks Noss for the question. So year-end 2020 is really our best guess. As you can imagine the patients that we are enrolling in our dry age-related macular degeneration trial are [Indecipherable] patients. This is obviously an at-risk population in the current pandemic and many of the ophthalmic practices has really limited their staff to essentially essential business and the screening new patients doesn't fall within that category and it was considered to be just too risky to take on that activity over the past several months. Now, we are over two-thirds enrolled in that trial, which gives us some advantage and we are seeing several of our sites have actually started screening again over the past few weeks. So we are seeing activity resume there.

I think what's driving our assumption of year-end is some conservative assumptions that these practices may reopen slowly that some of the academic centers Duke obviously with the state of our Phase 1 clinical trial for example, but we do have other academic centers that we're also working with an addition to retinal specialists. And so we're assuming that some of those academic centers and institutions may also be opening more fully as they prioritize their internal resources toward pandemic management.

But with that said, we have throughout the country and even if price are turning on kind of regionally in different pockets, we think that we're well balanced there and we think that the private practices will be up in screening and then going into the summer. And that's really what's driving our year-end. This is a one-year clinical trial, so one is we are fully enrolled a little bit ahead of year-end, I guess, we would have data in 2021, but we obviously need a month or two to close out the trial and get the data once we've announced complete enrollment. So I think that's something it's hard to give precise guidance on. And so we have our last patient enrolled. But it's something we'll continue to watch closely and I do expect we will be in a position to give more refined guidance on this next quarter, once we see how reopening emerges across the country.

Noss -- BMO Capital -- Analyst

That's very helpful. Thank you. And in terms of the new speaking to SBT-259, can you give us some color on what kind of preclinical data we are expected to see.

Reenie McCarthy -- Chief Executive Officer

Sure. For SBT-272, you'll remember that we had done some logic in star one model of ALS where we saw improvement in survival improvement in neuro filament light chain, which is a biomarker of external health as well as improved function. And so we're actually looking at SBT-272 in the second model ALS, which is the TDP 43 model. And so we are hoping to have data out in that model around the end of this year and we're also looking at the compound in a model of multiple system atrophy. So it's really, it's a prudent neuropathy, it's the part concerning unlike prudent neuropathy model. And so that data hopefully will also have out around year-end.

SBT-259 we're looking at it for peripheral neuropathy, so we're looking at it in a model of Charcot-Marie-Tooth for exploring other peripheral pain models there and then our 550 series, we're really to lead optimization, but also very excited about the potential about series which is mechanistically quite differentiated from elamipretide.

Noss -- BMO Capital -- Analyst

Sounds good. Thank you very much for your questions, I mean answers.

Reenie McCarthy -- Chief Executive Officer

Thank you for your questions.

Operator

Our next question comes from Yi Chen with H.C. Wain. Please go ahead.

Marcus -- H.C. Wainwright -- Analyst

Hi, this is Marcus [Phonetic] on behalf of Yi Chen. Congratulations on the progress. Thanks for taking my questions. Just a couple of clarifying question in terms of the timeline for the Barth syndrome discussions with the FDA. Could be NDA submission the second half of 2020 be delayed by COVID-19 and to clarify, are there any Barth syndrome patients receiving elamipretide and if so if is a data update from this. Thanks.

Reenie McCarthy -- Chief Executive Officer

Great, thanks for your questions Marcus. So in terms of our NDA submission timelines assuming we have a productive meeting this summer, we would still expect to be able to submit our NDA this year. So we don't expect delays in that associated with COVID-19 and in terms of Barth patients on drug, yes, there are eight patients who remain in the Barth open-label extension. We also have Barth patients in our expanded access program and so we are continuing to collect data certainly with respect to the open-label extension patients. The week 72 data from open-label extension is something FDA has asked us to brief them on at our meeting this summer and some of that data we've actually already released in scientific presentations and prior presentations.

In addition to the week-72 data, we do have some patients who have completed week-96. COVID-19 there will delay some visit. So we wouldn't at this point we're not sort of sure when we'll have that complete week-96 data for example. But as the open label goes on, we continue to take data cuts and we're obviously continuing to update the FDA. We are seeing continued improvements as Jim mentioned at all of the later data points.

Marcus -- H.C. Wainwright -- Analyst

Thanks very much and congrats again.

Reenie McCarthy -- Chief Executive Officer

Thank you.

Operator

Our next question comes from Maury Raycroft with Jefferies. Please go ahead.

Kevin Sheridan -- Jefferies -- Analyst

Hi, this is Kevin Sheridan for Maury. I just wanted to expand on the preclinical data for SBT-272 that you talked about before in terms of ALS and MSA. Are there any plans to do studies in non-human primates for this preclinical data. And then in terms of strategic partnerships and possibilities with this program, what are you thinking in terms of that. Thank you.

Reenie McCarthy -- Chief Executive Officer

Sure. Great question. Thank you. At this point, we have not made plans to do studies in non-human primates. We're doing early, and well-established models in the diseases of interest, but it's something that we could certainly consider depending on the data that comes out of those studies.

And then beyond in terms of sorry -- your second question was partnering opportunities. There is and there has been some interest in 272 differentiates from elamipretide in a couple of different ways. It more potent than elamipretide and we see higher concentrations through the blood-brain barrier so better concentrations in the CMS better concentrations potentially with that also in other membrane protected compartments such as the retina. And so with that, there has been some interest in some early conversations around partnering.

Brian, anything to add there?

Brian Blakey -- Chief Business Officer

No, that is exactly right. So we are very early kind of discussions are interest, but we'll wait for more data.

Reenie McCarthy -- Chief Executive Officer

Exactly. And for us, we do think that neurodegenerative diseases are a bit of a frontier for mitochondrial targeted therapeutics, many of the neurodegenerative diseases have known mitochondrial components and so we are excited to explore that more robustly with this class of compounds as well as with 550 class.

Kevin Sheridan -- Jefferies -- Analyst

Great, thanks and congrats.

Reenie McCarthy -- Chief Executive Officer

Thank you.

Operator

[Operator Instructions] And at this time we have no further audio questions.

Reenie McCarthy -- Chief Executive Officer

Great. Thank you for joining us today. Stay safe.

Operator

[Operator Closing Remarks]

Duration: 39 minutes

Call participants:

Henry Hess -- Chief Legal Counsel

Reenie McCarthy -- Chief Executive Officer

Rob Weiskopf -- Chief Financial Officer

Jim Carr -- Chief Clinical Development Officer

Brian Blakey -- Chief Business Officer

Christopher Marai -- Christopher Marai -- Analyst

Paul O'Brian -- ROTH Capital Partners -- Analyst

Noss -- BMO Capital -- Analyst

Marcus -- H.C. Wainwright -- Analyst

Kevin Sheridan -- Jefferies -- Analyst

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