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Stealth BioTherapeutics Corp (NASDAQ:MITO)
Q4 2019 Earnings Call
Apr 1, 2020, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Greetings and welcome to the Stealth BioTherapeutics Fiscal Year 2019 Financial Results and Recent Business Highlights Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mr. Henry Hess, Chief Legal Counsel for Stealth BioTherapeutics. Thank you. 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, expectations for discussions and possible opportunities with potential partners and collaborators, and discussions related to the company's financial position. 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's Form 20-F filed with the SEC on April 4, 2019. 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, Stealth's CEO. Reenie?

Reenie McCarthy -- Chief Executive Officer

Thank you, Henry, and thank you to everyone who has joined us this morning to review our full year financial results and recent corporate progress. With me today is Rob Weiskopf, our CFO; as well as Jim Carr, our Chief Clinical Development Officer; and Brian Blakey, our Chief Commercial Officer, in addition to Henry; and all of us will be available for question-and-answers.

I want to premise today's call by saying we're all working virtually, as I assume you are all as well. I hope everyone is faring well during these challenging times. Obviously, very challenging for some of the patient populations that we service as well.

We are off to a strong start in 2020 with a clear focus on advancing Elamipretide toward potential approval on Barth syndrome, an ultra-rare genetic condition characterized by cardiac abnormalities, often leading to heart failure, muscle weakness, recurrent infections, delayed growth and reduced life expectancy as a result of mitochondrial dysfunction.

We presented very strong data from our ongoing open label extension study early in the first quarter of last year at the American Society of Human Genetics 2019 Annual Meeting. That data demonstrated that treatment with Elamipretide resulted in a significant increase in average cardiac stroke volume. And more recently, we announced additional cardiac data at the American College of Cardiology 2020 Virtual Meeting, demonstrating significant improvements in left ventricular end-diastolic and end-systolic volumes, as well as trends in other cardiac parameters.

We also recently announced results from our SPIBA-001 natural history comparative control efficacy study in Barth patients, demonstrating a greater than 80 meter improvement in the primary endpoint of six-minute walk test at one year, compared to natural history controls with a p-value of 0.0005, as well as significant improvements in secondary endpoints of muscle strength by the time to stand, and a multi-domain Responder Index.

In early March, we announced that the FDA had granted us rare pediatric disease designation for Barth, for which we may be entitled to a rare pediatric voucher, should we receive approval in conjunction with an expedited review.

More recently, we met with the FDA to discuss the natural history comparative control efficacy study and the TAZPOWER open label extension, cardiac surrogate endpoint and functional endpoint data. Our meeting was productive and informative relative to our regulatory path forward, and we look forward to providing further details once we've received the meeting minutes.

We are actively exploring pipeline expansion opportunities in other rare metabolic cardiomyopathies. These include Duchenne and Becker's muscular dystrophies, Friedreich's ataxia, all of which entail heart failure as the leading cause of premature death. We've met with leading advocacy groups and we plan to convene a Cardiology Advisory Board to assess endpoints and trial design. We hope to meet with FDA to discuss this initiative toward the end of this year.

Moving onto our ophthalmic pipeline, we continue to enroll patients for our Phase 2b clinical trial, which is ReCLAIM-2b, which is evaluating the effect of Elamipretide in patients with dry AMD with geographic atrophy. We have Fast Track status on that program from the FDA.

The primary endpoint of the trial is agreed with the FDA as low luminance visual acuity, which is low light or night vision, particularly compromised in patients with geographic atrophy. We're also evaluating secondary endpoints, including other visual function endpoint. The rate of progression of GA by optical coherence tomography and fundus autofluorescence, as well as visual function and quality of life questionnaires.

Since our AMD trial is primarily being conducted in elderly patient population, we are experiencing some enrolment delay as a result of the COVID-19 pandemic. We are currently over 2/3 enrolled and we had anticipated completing enrolment during the first half of this year. In light of the impact of physical distancing restrictions on clinics and patients, to be conservative, we're adjusting our estimate of enrollment completion for the second half of this year. We will continue to monitor the situation closely, and we will make any necessary updates, should this change in a meaningful way.

We submitted our Phase 3 protocol for Elamipretide in Leber's hereditary optic neuropathy at the end of 2019. And we look forward to receiving comments from the FDA on that protocol. Consistent with prior guidance, we do not intend to initiate this protocol until 2021, due to financing constraints.

In January, we advanced our next generation product candidate, SBT-272, which has improved CNS penetration and is being evaluated for the treatment of ALS and rare neurodegenerative diseases into a Phase 1 trial to evaluate safety and tolerability, pharmacokinetics and appropriate dose range. The Phase 1 trial is a double-blind placebo controlled single ascending dose study, enrolling up to 40 healthy subjects across multiple cohorts. SBT-272 is being administered orally in this study.

We still expect multiple preclinical data readouts this year for SBT-272 and ALS, as well as multiple system atrophy, and for our third product candidate, SBT-259 in Charcot-Marie-Tooth. We are also progressing a novel series of small molecule compounds targeting the ferroptosis pathway of cell death, which is implicated in many neurodegenerative diseases, including Friedreich's ataxia and Parkinson's.

We are proud of our team for rallying, following our fourth quarter setback with MMPOWER 3 in primary mitochondrial myopathy falling short of its primary endpoints. We are extremely confident. In the promise of our current pipeline and our ongoing programs, we expect to catalyst rich year for the company. We look forward to keeping investors apprised of our virtual progress and we hope that it won't be quite such a virtual earnings call going into next quarter, although obviously that's an evolving situation.

And with that, I'd like to turn the call over to our CFO, Rob Weiskopf, to review the financial results for the year. Rob?

Rob Weiskopf -- Chief Financial Officer

Thanks, Reenie, and thank you all for joining us today. In 2019, we recognized $21.1 million in revenue associated with the Alexion arrangement entered into in October 2019. The revenue represents the portion of the non-refundable upfront payments that were recognized in full upon delivery of the top line data for our PMM trial. Alexion has since terminated the arrangement, and as such, no additional revenue will be recognized.

Research and development expenses were $44.6 million for the year ended December 31, 2019, down from $53.1 million for the year ended December 31, 2018. This decrease was primarily from a net decrease of $8.5 million in clinical trial costs due to the timing of the trials that ended in 2018, a $2.8 million decrease in contract manufacturing and $0.9 million decrease in discovery related expenses due to the timing of activities. These decreases were offset in part by increases of $3.6 million in employee and consultant related expenses, driven by the continued build-out of clinical medical affairs and regulatory functions, and $0.1 million in other costs.

General and administrative expenses were $22.3 million for the year ended December 31, 2019, compared to $22.2 million for the year ended December 31, 2018. The increase was primarily attributable to a net $2.3 million increase in pre-commercial activities, including building market disease awareness of primary mitochondrial myopathy, and $1.8 million increase in professional services for activities attributable to operating as a public company, an increase of $3.2 million in employee-related costs, offset by a decrease of $6.7 million in costs associated with the 2018 financing efforts and a decrease in legal IP fees of $0.5 million.

Other expenses totaled $25.9 million for the year ended December 31, 2019, compared to $21.4 million for the year ended December 31, 2018. The increase in other expenses is primarily attributable to a $22.7 million loss on extinguishment of debt recorded with respect to the convertible debt conversion into ordinary shares in conjunction with the company's 2019 initial public offering, and $0.7 million change period-over-period in the fair value adjustments of the warrant liability. These increases were offset by a $3.4 million change in period-over-period fair value adjustments of the derivative liability associated with convertible debt, a decrease in interest expense mostly related to the convertible debt of $14.7 million and an increase in interest income of $0.8 million.

We ended the year with cash and cash equivalents of $50.8 million at December 31, 2019, which compares to $10.9 million at December 31, 2018.

With that, I will turn the call back to Reenie.

Operator

One moment, please. We're experiencing a technical difficulty. Now, we're connecting Reenie.

Reenie McCarthy -- Chief Executive Officer

Thanks, guys. That was a hiccup on my end. Tried to unmute myself and I hung up instead. So, before we open up for questions, I want to reiterate again how pleased we are with the progress we've made this quarter, how excited we are with the progress we're making with our pipeline of mitochondrial targeted therapeutics.

There is a rich history of mitochondrial dysfunction contributing to cardiac ophthalmic and neurological diseases, an extensive preclinical data demonstrating the promise of Elamipretide and our other pipeline compounds in these areas. We're confident that we're poised to execute on that promise. I'm happy to open up the line for any questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Good morning, Reenie and team. Thank you for taking our questions. And congratulations on recent progress with the agency. I wanted to ask you about that recent meeting. And it makes sense to me that you would wait for full minutes to be able to provide some guidance going forward. But you characterize it as productive and informative. And I guess we've talked in the past about a couple of scenarios going forward with regard to Elamipretide in Barth. And I'm wondering if you can provide any additional granularity on what you anticipate to be the most likely scenario if we think 12 months out from now?

Reenie McCarthy -- Chief Executive Officer

So, it was a very productive and collaborative meeting with the FDA, Charles, and I appreciate you for asking the question. We had a number of FDA participants, very senior participants actually in attendance. You may or may not be aware, but the Division of Gastroenterology and Inborn Errors has now reorganized into essentially a rare disease division. So, the head of that division, the Director and Deputy Director were both on the phone, as well as the Office Director. And the FDA -- just have to give a shoutout to the FDA. This is obviously a very challenging time for the FDA, and they have a lot going on. They got us comments in advance, something like 10:30 PM on Thursday night ahead of the meeting.

And so, part of the conversation that we had with the FDA is centered really on the existing data set that we have from our existing trial and request to provide some additional analyses. I think we've mentioned in the past that we had presented data to the FDA out to week 36 of open-label extension. We have data out to week 72 of open label extension. So, the FDA recognized the severity of Barth syndrome, at least recognized the challenges that it would entail to do another trial in Barth syndrome. And so, really did ask us to provide some additional analyses of the data out to week 72, which we previously announced that data and it remains consistent.

And so, we're continuing to engage with the FDA on that front, really on the basis of the existing dataset. So, still hopeful about filing an NDA in the coming months on Barth syndrome from that perspective.

Charles Duncan -- Cantor Fitzgerald -- Analyst

That's helpful, Reenie. Do you have a pre-NDA meeting planned or are you -- are they waiting really to kind of green light, that next step, should it occur after they see this additional information?

Reenie McCarthy -- Chief Executive Officer

Well, so we were waiting for this meeting prior to submitting a pre-NDA meeting request. And so, that means the pre-NDA meeting is not yet scheduled.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. Okay. And then as you imagine, perhaps broader utility of Elamipretide into other neuro developmental disorders such as DMD and Friedreich's; I think you'd mentioned the Cardiology Advisory Board, when do you anticipate holding that and when can we get some visibility on, call it, the outcome and thoughts in terms of going to the agency later this year?

Reenie McCarthy -- Chief Executive Officer

That's a great question. And Jim is on the phone. We are trying to work through the virtual scheduling of that add. Jim, we're targeting sometime this quarter?

Jim Carr -- Chief Clinical Development Officer

Yes, this quarter --

Reenie McCarthy -- Chief Executive Officer

Go ahead Jim.

Jim Carr -- Chief Clinical Development Officer

No. No, I was just going to say we have the attendee list, and it's just as Reenie mentioned, it's just working through the logistical challenges that exist that we're hoping for this quarter.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yes. I understand that, Jim. Jim, Reenie, is the key question for then Advisory Board, whether or not cardiovascular is a challenge for these patients, or can it be measured within a reasonable period of time? What is really the thing you'd like to learn in talking to them?

Reenie McCarthy -- Chief Executive Officer

I'll let you take that, Jim.

Jim Carr -- Chief Clinical Development Officer

Yes, of course. So, our impression, our view is that the observations from Barth are applicable to other rare disease cardiomyopathies. And Friedreich's ataxia and Duchenne muscular dystrophy are certainly at the top of the list. So, we want to get consensus that those findings are applicable to those patient populations. We feel that they are, but there is a lot of granularity involved.

So, for example, when does one introduce Elamipretide in the setting of DMD, for example, just knowing the progression of the cardiomyopathy that ensues for most patients? What is the most meaningful time to introduce it? What would the endpoints be etc.? So, again, just gaining more granularity about how we would actually pursue those endeavors.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay, that's helpful. Last question for Rob or -- yes, Rob. I guess I'm on the West Coast, so maybe the espresso hasn't kicked in yet. But I -- so, I may have missed this, but did you talk about a guidance for going forward in terms of cash spend this year?

Rob Weiskopf -- Chief Financial Officer

No, not at this point.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay. And is there a key lever that you're waiting for to come up with that?

Rob Weiskopf -- Chief Financial Officer

Well, I think that if we look at our cash and equivalents of $50.8 million at December 31. And in conjunction with the reduction in operating expenses through the corporate reorganization that we did, our fund should be sufficient to fund operations through multiple inflection points, including the Barth NDA filing in the second half of 2020, as well as enrollment completion of dry AMD study.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Okay, that's all I need. Thanks for taking my questions.

Rob Weiskopf -- Chief Financial Officer

Sure.

Operator

Thank you. Our next question comes from the line of Christopher Marai with Nomura Instinet. Please proceed with your question.

Christopher Marai -- Nomura Instinet -- Analyst

Hey, good morning, and thank you for taking my questions. Congrats on the progress. I was wondering if first, we can touch upon some of the potential data that you may be seeing for your next generation assets? You started the first in-human trials of 272 in healthy subjects. And I was wondering the type of data you might expect to see from that study and how we might be able to compare that to Elamipretide to understand the molecules characteristics and potential flexibility going forward?

Reenie McCarthy -- Chief Executive Officer

Jim, do you want to take that question?

Jim Carr -- Chief Clinical Development Officer

Sure. So, Chris, the ongoing Phase 1 study with 272, for example, is a traditional Phase 1 first in-human single extending dose design trial. So, the primary objective of those kinds of trials is, of course, safety. The PK is also a component of that. So, the trial is ongoing. Again, so we expect to get an impression about safety and impression of PK.

Reenie McCarthy -- Chief Executive Officer

And then, I think hopefully then, sort of, triaging that with what we're seeing in preclinical models that we're running at the same time.

Christopher Marai -- Nomura Instinet -- Analyst

Okay. Yes, I guess I was curious if you might have any other target engagement type data, anything else in that study just to be able to benchmark it versus Elamipretide or other bioavailability data that could be potentially helpful, suggests that the molecule behaves differently from Elamipretide in the ways that you were hoping. So, is it my understanding that that won't be there, it's just sort of safety PK-PD?

Reenie McCarthy -- Chief Executive Officer

Safety PK-PD at this point in time. Sort of moving forward we might look to essentially get sort of CNS penetration, but not in this first study.

Christopher Marai -- Nomura Instinet -- Analyst

Okay, great. And then secondarily, I understand you expect feedback from the FDA; how should we think about the potential in Europe for Elamipretide in Barth? Obviously, it's a relatively small population, so Europe might be something addressable also by Stealth. Could you maybe walk us through your plans to address that opportunity? And then lastly, with respect to the FDA, you need to present, I guess, additional data analysis out to week 72. So, beyond getting the meeting minutes, what might be the gating factor, the timeline that it takes to get that analysis to the FDA? Thank you.

Reenie McCarthy -- Chief Executive Officer

Okay. So, I'm going to ask Brian to speak to Europe and Barth. I'll answer your second question first, and then hand it over to Brian. In terms of timelines for additional data to the FDA, we do have the week 72 analyses. We would have to -- so, we have them internally. This is an open label extension. So, provision of those to the FDA is -- would be a fairly rapid undertaking for us. We would want to update our CSR with formal outputs, which requires the data cut and a little bit more of external lifting. So, that timeline could take a little bit longer, but frankly would still fall within the original timeline for data cuts to support our NDA, to do those formal output.

So, the provision of top line information to the FDA can happen quite rapidly from that perspective. So, we are expecting to be able to turnaround the analyses that they've requested and get those back into them shortly.

So, Brian, do you want to talk about Europe and Barth?

Brian Blakey -- Chief Business Officer

I will do. Good morning, Chris. Hope you have a good morning. So, we have done some preliminary work in Europe. I'm talking to some of the -- with the larger countries in the Big-5-- Germany, France, U.K. --about reimbursement for Barth. As you would expect, it is an easier road for reimbursement for Barth because it's such a small population and because of the devastation of the disease. So right now, we are evaluating -- we're working ourselves at being able to go ahead and promote it into Europe versus -- we're in very early discussions with some strategic to kind of do an analysis of which is better for us to do it, or to be able to hand it off.

So, I think we'll be evaluating that over the next couple of quarters to see where we land and then move forward with that decision.

Christopher Marai -- Nomura Instinet -- Analyst

Okay, great. And then in Europe, just with respect to promoting the product, is it possible to leverage other potential compassionate access use pathways there to get the drug to patients without going through the formal approval process? I know some companies have previously done that without -- and at least processes enabled them to market the drug without a formal approval --

Brian Blakey -- Chief Business Officer

Yes. Yes --

Christopher Marai -- Nomura Instinet -- Analyst

And actually, commercialize it. So, is that how the company looks to bring the drug to patients in the Europe region going forward?

Brian Blakey -- Chief Business Officer

I think, Chris, that's one of the options we're definitely evaluating, is through the compassionate use or expanded access programs to be able to get patients access to the drug and then convert them over and also start the reimbursement process. So, one of the areas that we are evaluating along with the strategic and then just a general promotion, what that would cost us to be able to do that.

Christopher Marai -- Nomura Instinet -- Analyst

Okay, great. Thank you.

Reenie McCarthy -- Chief Executive Officer

Thanks, Chris.

Operator

Thank you. Our next question comes from the line of Matthew Luchini with BMO. Please proceed with your question.

Matthew Luchini -- BMO Capital Markets -- Analyst

Hi. Good morning, everyone. Thank you for taking the questions. So, I guess, first, it sounds like what you're saying is the Company is -- I wanted to come back to the question of cash. It sounds like what you're saying is the Company is funded until the end of the year, essentially even with expense reductions in place. And so, just want to maybe have you guys talk little bit about how you're thinking about options to address cash needs beyond that point? I mean, you highlighted the pediatric voucher. Maybe talk a little about what else you're considering, if it's business development of some sort? And then, I guess more broadly, how we should be thinking about, I guess, the relative prioritization of some of the different projects that are going on, BARRX versus dry AMD versus certain of these early programs? Especially, given, say, with the delay in AMD data now being pushed presumably to no earlier than, let's say, mid-'21 at the earliest. So, just help us think through how you guys are thinking about the company's evolution as we move from the end of the year as you've got these sort of important data points to keeping things moving as we move into '21? Thank you.

Reenie McCarthy -- Chief Executive Officer

Yes, thanks for the questions, Matt. So, in terms of how we're thinking about addressing cash needs going forward, that's obviously something that's dynamic and ongoing. We look at all options and explore all options. We do think that the potential of the pediatric voucher in Barth is material for us, could potentially fund us through Barth launch and potentially some additional indications, expansion opportunities. So, that is fairly material, but we would be expecting to see that potentially coming -- earliest would probably be Q1 of next year.

So, in terms of other opportunities, business development, discussions remain ongoing. There is certainly some interest particularly in the ophthalmic programs on the BD side. In terms of prioritization of projects, I think that Barth really does remain our priority focused, but it's primarily regulatory spend at this point, right? So, open-label extension remains ongoing. But from a resource allocation perspective, those are mostly regulatory efforts that we're doing the lifting on right now and in the related clinical support.

AMD, we are evaluating the data in AMD, looking to really understand the impact of the recruitment slowdown. I think we're going to have better insight into that coming out of next quarter, because we'll hopefully understand the full scope of it. We did have the potential to do interim analysis of the AMD data. If you recall, in Phase 1, we saw statistically significant improvements from baseline and visual function at six-months, for example. So, potential there to do a data cut earlier at six or nine-months in versus 12. So, those are all things that we have under consideration as we look going forward.

The preclinical work, we think it's important and is not taking significant resources. It's a lot cheaper to do mouse studies than it is to do human studies. So, we do think it's important to keep moving our pipeline forward. And again, there is some partnering entity interest around that as well.

Matthew Luchini -- BMO Capital Markets -- Analyst

Okay, thank you. And I guess maybe in the context of the Barth NDA, can you just remind us, are there any remaining either talks work that needs to be done or other preclinical activities? Basically, what I'm thinking about is anything where there is animal work that requires regular human interaction, such that that is challenge in terms of people even being able to get into the lab today?

Reenie McCarthy -- Chief Executive Officer

No.

Matthew Luchini -- BMO Capital Markets -- Analyst

Is there anything like that for Barth?

Reenie McCarthy -- Chief Executive Officer

No, there is not. In fact, DNP, so we've had a long regulatory history with Barth, as you may recall. When we met with DNP, last spring, on the Barth program, they had signed off on our preclinical package -- non-clinical package --

Matthew Luchini -- BMO Capital Markets -- Analyst

Okay, great. Thank you for taking my questions.

Reenie McCarthy -- Chief Executive Officer

Yes.

Operator

Thank you. Our next question comes from the line of Yi Chen with H.C. Wainwright. Please proceed with your question.

Yi Chen -- H.C. Wainwright & Co., LLC -- Analyst

Thank you for taking my question. Given the current situation, the coronavirus, when do you think the pre-NDA meeting is likely to occur and how soon can the company submit the NDA for Barth syndrome after the meeting?

Reenie McCarthy -- Chief Executive Officer

Thanks, Yi Chen. So, I think we're going to have to -- that question probably depends on more on FDA than on us. But based on the interaction we've just had-- well, it was a little awkward to do by phone with the FDA --the FDA was extremely responsive, as I mentioned, kind of staying up until 10:30 at night to get us comments well ahead of this meeting on Thursday, which is well ahead from FDA perspective. And then, holding the virtual meeting, which was very productive with a lot of FDA members in attendance.

So, it seems from our limited viewpoint of the world, the FDA is doing everything they can to keep business moving. They reiterated several times on our call that they are keenly aware that patients are waiting, that is a severe devastating disease, and that we got a true sense of partnership and collaboration from the FDA.

So, with that, I think possible to have a pre-NDA meeting in the second quarter. Again, I can't speak for FDA. But we still think that's a possibility which would still keep us on-track for NDA submission in the second half of this year, which was our original timeline.

Yi Chen -- H.C. Wainwright & Co., LLC -- Analyst

Okay. Second question, could you verify that the Phase 3 protocol for LHON has already been finalized with FDA inputs, and it's just that you are now starting the trial until 2021?

Reenie McCarthy -- Chief Executive Officer

You know, we submitted that protocol in December to the FDA and we have not received feedback from the FDA on it yet. So, we would like to receive that feedback. We did align with FDA on what endpoints we could look at in that protocol when we met with them last spring, so we do feel that we have high level of alignment with the FDA on endpoints. But we certainly welcome their feedback on other aspects of trial design. And this time, before we initiate the trial, we think will enable us the time to get that feedback. It's always better to have it going into the trial.

Yi Chen -- H.C. Wainwright & Co., LLC -- Analyst

Got it. Lastly, could you update us on the topical ocular formulation of Elamipretide? Is it already being developed?

Reenie McCarthy -- Chief Executive Officer

So, we have used the topical ophthalmic formulation in the LHON Phase 2 study that we did. That was with eye drops. Our plan for Phase 3 was to move to sub-q, because we think there's higher concentrations in the retina. And what we are looking at doing, and we are -- this work is currently in progress, is developing an IVT formulation of Elamipretide.

Yi Chen -- H.C. Wainwright & Co., LLC -- Analyst

So, this ocular formulation is the same formulation that's going to be used in the future dry AMD trials after Phase 2b?

Reenie McCarthy -- Chief Executive Officer

After Phase 2b, we are exploring the potential of using an IVT formulation for AMD.

Yi Chen -- H.C. Wainwright & Co., LLC -- Analyst

Okay, got it. Thank you.

Reenie McCarthy -- Chief Executive Officer

Yes.

Operator

Thank you. [Operator Instructions] Our next question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.

Maury Raycroft -- Jefferies Group LLC -- Analyst

Hi, everyone. Good morning and thanks for taking my questions. I just had a few quick clarification questions. First one is for 272. For the initial Phase 1 clinical data, is that still expected 2Q? And I was just wondering if that Phase 1 with clinical sites is posted online anywhere?

Reenie McCarthy -- Chief Executive Officer

So, that is being conducted in the U.K. And so, I do not believe it is posted online anywhere. And in terms of timing of that data, I don't think Jim is on the line any longer, because he had another call at 9:00. So, we may face some short -- some small delays, because of COVID, sort of in the subsequent cohorts of that, so I would say Q2 into Q3. It doesn't impact any of our timelines in terms of what we were thinking about initiating other studies, because the preclinical data that we need to support those won't be until end of the year.

Maury Raycroft -- Jefferies Group LLC -- Analyst

All right, OK. Okay. And then for the mid-year guidance for Elamipretide, will that be guidance specifically based on the minutes or will it be based on the FDA's feedback on the requested 72-week analysis too? And do you view this more as an update over the summer or could it be a fall update?

Reenie McCarthy -- Chief Executive Officer

I would hope to be providing an update over the summer. And I think-- to answer your question --we're kind of, we've literally just met with the FDA yesterday. So, I think we need a little bit more time as a team to kind of give guidance in terms of when we'll be submitting our next meeting request and just how we expect that back and forth to go. And we'll also have to see -- again, FDA is constrained, although, very impressively responding to us to-date. So, we'll have to see how that plays out over the next few weeks, but we would hope to provide an update both on sort of minutes and hopefully subsequent interactions, and we would hope that to be early summer timeframe.

Maury Raycroft -- Jefferies Group LLC -- Analyst

Okay. So, it could include some feedback on the 72-week analysis as well?

Reenie McCarthy -- Chief Executive Officer

Yes, it could.

Maury Raycroft -- Jefferies Group LLC -- Analyst

It just depends on the FDA, OK. Okay.

Reenie McCarthy -- Chief Executive Officer

Yes, I just don't want to speak for them, because this -- these are kind of unprecedented times. So, I can't really rely on typical timelines from their perspective. But everything we've seen, suggests that they are very responsive to us and very collaborative. And so, we are optimistic that we'll be business as usual from that perspective, that's certainly what they've demonstrated thus far.

Maury Raycroft -- Jefferies Group LLC -- Analyst

Okay. Thank you for taking my questions.

Reenie McCarthy -- Chief Executive Officer

Yes. Thanks, Maury.

Operator

Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Ms. McCarthy for any final comments.

Reenie McCarthy -- Chief Executive Officer

So, appreciate everybody for hopping on the phone today, appreciate the questions, and hope everyone is doing well in these challenging times. Stay safe out there. And we are, again, very optimistic about the milestones that we have coming forward. The team is continuing to make progress and we remain confident that we can deliver on our goals for this year. Thanks for your time.

Operator

[Operator Closing Remarks]

Duration: 37 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

Charles Duncan -- Cantor Fitzgerald -- Analyst

Christopher Marai -- Nomura Instinet -- Analyst

Matthew Luchini -- BMO Capital Markets -- Analyst

Yi Chen -- H.C. Wainwright & Co., LLC -- Analyst

Maury Raycroft -- Jefferies Group LLC -- Analyst

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