Harvard Apparatus Regenerative Technology Inc.

Harvard Apparatus Regenerative Technology Inc.

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Harvard Apparatus Regenerative Technology Inc.US flagOther OTC
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Q3 FY2016 · Earnings Call TranscriptNovember 11, 2016

APIChatGPT

Operator

Thank you all for joining us this morning for the Biostage Business Update Conference Call and Webcast. Today’s webcast will be accompanied by a slide presentation that can be found under the Investor section of the Company’s website www.biostage.com under Events and Presentations.

At this time, I would like to remind our listeners that remarks made during this call may state management’s intentions, hopes, beliefs, expectations or predictions of the future. These are forward-looking statements that involve risks and uncertainties.

Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the Federal Securities Laws. These forward-looking statements are based on Biostage’s current expectations and actual results could differ materially.

As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Biostage files with the Securities and Exchange Commission.

These documents are available in the Investor section of the Company’s website and on the Securities and Exchange Commission website. We encourage you to review these documents carefully.

Following the Company’s prepared remarks the call will be opened up for question-and-answer session. It is now my pleasure to turn the call over to the Chief Financial Officer of Biostage, Mr.

Tom McNaughton.

Tom McNaughton

Thank you. Good morning everyone and thank you for joining our call.

This is an exciting time for us at Biostage and we are very pleased to be able to share with you some significant momentum. As you know, we reported earlier this morning, our Q3 earnings results and update on our recent operational progress and commentary on our near-term milestones.

We are a preclinical research biotechnology company that is now transitioning becoming a clinical stage company in the next year. As such, we are measuring more against progress towards achieving our strategic milestones and much less on a quarterly P&L.

And we’ll also talk today about the very significant progress we made over the past several months against the 2016 plan specifically in the past quarter. Therefore I’ll first give an overview of our Q3 financial results, and then turn the call over to Jim McGorry, our CEO.

Jim will then walk you through the Company’s recent developments and exciting milestones, which outlined what you could expect from Biostage in the months ahead. He’ll then open the call to take your questions.

Dr. Saverio La Francesca, our Executive Vice President and Chief Medical Officer, who join us for that part of the call.

So let me start. We reported a Q3 2016 net loss of $3.1 million or $0.18 per basic share today, compared with $2.3 million net loss or $0.19 per basic share last year for the third quarter.

The increase was primarily due to greater R&D expense this year, which increased $900,000 to $2.2 million, compared with $1.3 million in Q3 2015. The increase due primarily to greater spending on preclinical studies of approximately $0.5 million outsourced lab services of approximately $100,000 and payroll-related and other expenses totaling about $300,000.

SG&A expense decreased to $100,000 for the quarter to $900,000, compared with $1 million in the prior year. We used cash and operating activities of $2.1 million in Q3 2016, compared with $1.8 million in Q3 2015.

And we ended the third quarter with $6 million of cash on hand. I’ll now turn the call over to Jim.

Jim McGorry

Thank you, Tom. Good morning, I’m really excited to be able to talk to all of you today, but why?

Because this is really an exciting moment to revisit the ongoing meaningful progress at Biostage, I’m sure you picked up on our theme, pivoting towards a clinical stage company. That I would like to use this moment to be able to walk you through that journey how did we get here and where are we going from here.

But let me acknowledge upfront two relevant questions. One, I’m concerned that you moved back the IND and what is the status.

And question two, you did not seem to have the cash to get to the IND or to the Phase 1 clinical. I want to acknowledge to our investors and shareholders that these are valid questions and I will invest and I will like to address these questions both upfront and totally during our presentation.

And I hope at the end of the discussion that I can reassure you that we have a solid plan to be able to move forward and a number of alternatives for financing for our company to bridge to these near-term milestones. All great solutions and breakthroughs start with a problem.

And what is the problem that Biostage addresses. The surgical complication of the esophageal cancer and this is important because there are 15,000 patients in both the United States and Europe that face a surgical procedure for their esophageal cancer.

And the current standard of care is stretching the stomach, stapling the stomach from a bagpipe shape through a tube and expanding that from the stomach cavity into the chest cavity and that problem results in high morbidity and mortality. And in some cases a five-year survival between 15% and 20%.

So simply there needs to be a better way. And so what really is Biostage all about.

Biostage is all about a solution for these underserved patients. Our Cellframe technology is a bioengineered construct which acts as a temporary scaffold for the reconstruction of the esophagus.

And so I would like to take you through that to hope you better understand what we are seeing into regeneration, what our goals are and how we are moving forward in focusing on both the problem and the solution. And to do that, let me take you through the Cellframe technology solution by providing additional color on our clinical study protocol and the different phases of regeneration.

By understanding the regeneration, you will hopefully see what was our initial rationale for filing our IND with the FDA, our current rationale and really importantly to the supporting evidence that we have that exceeds the FDA requirements. Our ultimate goal is clear to be able to translate what we believe is our groundbreaking and breakthrough technology to the clinic of making this available to patients.

So you can see in the three pictures on the slide of segmental esophageal replacement. What I described right now is that tumor that needs to be removed into that day of surgery into day zero.

And instead of all of that stomach pull up our elegant solution is that the placement of our Cellspan esophageal implant, implanted with 30 million mesenchymal stem cells from that patient. We see in 21 days a rapid regeneration a connective vascular tissue that forms over the top of that scaffold.

You can see in the second picture how that forms over the top. And then at 21 days, a nonsurgical procedure that scaffold is removed and what is totally in place is remodeling a biologic response where the integrity of that esophagus has been regenerated.

At 90 days we see that remodeling of an epithelial layer and the mucosal layer at 180 days we really see, we see further remodeling of muscle layers and other areas. I just wanted to also point out picture three that is a scaffold removal.

So at about 21 days that scaffold is pulled out and what is only left is a biologic response. At the end of the day, this is what Biostage has been working on.

Animal studies to be able to show our regeneration. Our idea in focusing on the FDA, we have a clear path of a rationale to file on 90-day data, a 180-day data and data post that those 180 days.

The FDA asked us to be able to have a total clinical plan based on that 180-day data and some animals to go on longer than that. With that right now I also want to point out that we have animals ongoing from the study with Mayo, that are alive and doing well nine months after that original surgery.

And so we are very, very pleased of the progress that we have made and the continuous work that we have. So let me totally focus a little bit more towards the FDA.

I know when you move anything back. It causes concern what’s going on with the company are things not right.

A 13 hour clock that we worry about is everything wrong. But I want to say that we had a very productive conversation with the FDA on the third of October.

The FDA had 14 people on the call. They had engineers and clinical people, people from the device side and people from the biologic side.

But let me highlight who we had on the call. So Dr.

– our Chief Medical Officer, Dr. Saverio La Francesca, who I just want to remind you left one of the most prominent heart practices to be able to go in the industry because he felt that we could move this therapeutic forward right here.

We also had our Chief Scientific Officer, Dr. Harout DerSimonian and Laura Mondano, our Head of Regulatory, who is responsible for Genzyme, Cell Biology and the last three years, Histogenics another very key cell therapy area.

We were also joined by three experts. Dr.

Dennis Wigle, Chief of Thoracic Surgery at Mayo Clinic; and Saverio is there today at the Mayo Clinic with Dr. Wigle doing further animal studies.

It goes to show we are continuing to move these pieces forward. Dr.

Andy Balber at Duke University, an expert on mesenchymal stem cells and Dr. Chuck Cox, Ph.D., M.D.

University of Texas, another expert on mesenchymal stem cells, a pediatric surgeon and someone who has been involved in numerous INDs. So in principle we agreed on a number of key areas that are Phase 1 clinical approach the number of patients, the patient population.

Dr. Wigle took the FDA, educating the FDA through that patient population because that’s key.

We do have a complex in breakthrough area. And I believe the FDA recognized that they recognized that our potential solution is a dramatic change to the way that these patients are treated now.

And they wanted to ensure that all areas were understood. We talked about our total preclinical package and we talked about that where this regeneration was mechanical updates, updates on histology, updates on the characterization of the cells.

And at the end of the day, we have much greater line of sight on the key issues with the FDA that de-risk our overall program. People can rush and put in an IND.

But if the FDA does not like that they will go on immediate clinical trial hold. We believe that the upfront dialogue that we have had now with the FDA gives us a clearer point of view to be able to move forward towards our ultimate goal of getting this product to help patients.

So how are we doing that and what’s next. Our beacon, our goal, our eye on the goal is to be able to bring this therapy into humans.

And that is what we are focusing on translational medicine that is what Mayo Clinic is totally focusing on with us. And that is why this is really an important time.

Those meaningful data, it is developing meaningful data that that will bring a company forward. And so we’re submitting our manuscript with Mayo Clinic by the end of the year on our esophageal regeneration.

Saverio is working with the Mayo Clinic and we’re very excited on that progress. What else is going on and why is 2017 going to be totally proved out to be a transformational year for Biostage.

There’s much going on as we transition towards a critical stage company. What does that really mean it means that we’re building out our quality in regulatory and clinical capabilities of our company and the very good thing is it does not take dramatic dollars to change to be able to do and execute to where we are.

We have all the elements to build right now. And execute as a clinical stage company.

We’re continuing our ongoing studies with our esophageal implant. And we hope to continue to be able to update you on these ongoing studies as data will be available in early 2017 and ongoing through that study.

We’re looking again to file that that our IND into Q3 and commence because we will be working in parallel those human clinical studies into Q4 2017. So how are we going to get there?

And so look I wanted to address the area right up front in terms of financing. You’ve seen our current cash from what Tom went over.

We have $6 million of cash at the end of the quarter. You can see our historical burn.

You can see where we are going forward but I want you to know that we are confident that we’re making substantial progress in our company but we also are making much progress on multiple financing options. Our goal is to propel Biostage forward with a plan that’s in the best interest of our current shareholders and our future shareholders.

And look I know you want more information here. I know that you also know that I’m not at liberty to share with you the details of a number of these confidential conversations.

But let me give you this to you from my point up close and personal. I did not take this assignment as CEO at Biostage to be able to sell this company out short to be able – not to be able to carry forward this, what we believe is groundbreaking technology and bring this into patients.

I believe we have a disruptive technology. I’m learning tremendously from others, advisors and numerous conversations about capital markets and strategically funding this company going forward.

I’m in constant conversation strategically around moving this forward and you have my commitment that we will continue to be able to see the real value of the company and to be able to at the right time make the transaction and look do I worry about that. Am I stressed about bringing the money in and executing?

Course I am, but I also have turned that stress into action and action in our team to find the right time, the right alternatives to move this company forward. So what lies ahead and what lies ahead for 2017.

I hope that you see we better understand the clear problem that we’re addressing, the solution that we have but we also see beyond that how we’re going to move in a speed to market. How quickly we can hopefully move from a Phase 1 pilot to hopefully will be a Phase 2 registration study.

Why? Why?

We’re focusing on life threatening areas in disruptive technologies. And that is not done through a Phase 3 trial because you don’t have a comparator.

So we do have a key speed to market. 2017 emerges as a key transformational year.

We hope to receive our orphan designation any time into early 2017 or possibly before. We will continue to update all of you on our significant scientific data readouts both on our current GLP study and number of studies with GLP also in pediatric atresia, the bronchus with Mayo Clinic and our full platform of our Cellspan implants.

We have good line of sight as I talked about with filing that IND for our esophageal implant into Q3. And we will emerge into the next number of quarters and into the next year as a clinical stage company that’s what we’re building to, that’s what we’re building the capability to and that’s what we have and we’ll continue.

I think the other thing that when you have short of cash, you’re very focused. And we’re very focused on executing.

On our esophageal implant, yes, we’re happy to have other areas within the bronchus and the trachea and pediatric atresia but we are very focused with our cash, very focused on doing what we need to do. So 2017 a very important year, so I would like to reassure you that we have a plan and meaningful plan and a number of alternatives to fund this company going forward.

I thank you very much for this opportunity to address you. Now I’d like to open it up for questions.

Operator

Thank you. Ladies and gentlemen, we will now be conducting a question-and-answer session.

[Operator Instructions] Our first question comes from the line of Laura Engel with Stonegate. Please proceed with your question.

Laura Engel

Good morning, thank you for taking my question or questions. The extension that the current trials and then the proposed Phase 1 study design, what else will you learn or what – how can that further de-risk given the results and I guess the observation longer term than you excited?

Tom McNaughton

Thank you, Laura. The extension is to be able to have a comprehensive clinical – preclinical plan for the FDA.

To be able to have the full characterization of the mesenchymal stem cells and to be able to have different time points on the fate of the cells, the potency of those cells and the mechanical properties that we see in this regeneration. We believe that this de-risks us because we’ve had substantive dialogues of agreeing of what these stages are.

And I think we know the feedback from the FDA of what they were looking for. So we believe these areas, de-risk us going forward.

And also in other areas towards the Phase 1 this would give us better insight into that regeneration. The mechanism of action and to be able to better define what that mechanism is what we are seeing.

And so we can replicate this data across. So we believe that all the data continues to be able to build.

In the 30 large animals that we have done to-date, we have seen very consistent regeneration of how it happens, when it happens and we continue to look to improve that so that’s why we believe this de-risk our opportunity.

Laura Engel

Okay, and then on the – this is the design of the Phase 1 kind of progresses, can you give us or what can you tell us on this current estimates for maybe the size of that study and estimated ballpark cost perhaps?

Tom McNaughton

Yes, thank you very much. The Phase 1 study that we’re looking at is focused on a segmental esophageal reception to better understand the safety and feasibility of that Cellspan implant.

So it’s a safety study into Phase 1 that was submitted for six patients. And so we’re very pleased with you can see a very focused patient population for a early stage patient that has a T2 lesion, an early lesion that has not metastasized.

The current standard of care for that patient right now is you have to then take out that lesion, but now what. Now they have to go from just taking out that tumor to that giant complex surgery that I’ve described earlier.

And so our Phase 1 study on those six patients is to show the safety and feasibility for that segmental esophageal reception. And if we can do that and show that into humans that will hopefully translate into humans from the robust animal studies that we have now, we believe that will very favorably position us for a Phase 2 open-label registration study.

Laura Engel

Okay. And then, as far as the 2017 plans for the bronchus days, how similar might this be in design to what you’ve already learned from esophageal?

Tom McNaughton

Thanks. One could describe what we’re doing ourselves on a scaffold, right.

Laura Engel

Right.

Tom McNaughton

And so that what – that it is. And so in that way it’s similar.

I will comment that into our pediatric atresia, it is – we can make our tech in pediatric atresia almost is identical to ours esophageal implant. That is – it is a removable scaffold, a temporary scaffold to have that bioengineered construct and we are exploring in number of other areas.

The bronchus nail [ph] continues to be able to be very, very bullish on the bronchus, mainly due to the size of that market. There are 40,000 additional cases, new incidents of bronchial central lung cancer here.

It is a very big number. We are exploring a – our continued retrievable scaffold and we are also experimenting with a resolvable scaffold into that area.

But I just want to underscore my main point. It is great to be able to have this platform, but we are absolutely focused on our esophageal IND because that will provide the foundation for all of these other things along the way.

Laura Engel

Perfect. Okay.

Well, very helpful, I appreciate the responses and I will hop back in the queue.

Operator

Thank you. Our next question comes from the line of [indiscernible].

Please proceed with your question.

Unidentified Analyst

Good morning and thank you for giving me an opportunity to ask a few questions. I was just wondering if you might be able to verify, it sounds to me like the large animal study is going to be at least 12 months long for the data that you’ll provide to the FDA in the IND application.

And I was also wondering, it also sounds like you’re doing at least some biopsy samples. And are you seeing at some point in time already a stabilization of the cell populations at various times after the implantation?

Jim McGorry

Thank you. Let me first comment.

The discussion with the agency is a full comprehensive pre-clinical package. Our focus is at 180 days and then a follow-up on selective animal path.

I believe you made an assumption that it was a year, I think that’s both accurate and inaccurate. The time of our study is 180 days with selective follow-up post stent removal.

I put those different time points on that earlier slide to be able to come back to a level of persuasion around that. The other point is I just want to dry out is we do have animals that are alive and doing well, out nine months, nine months right now and that’s the piece that we’re just continuing to do.

Some can ask the question, how does this technology work five years out? We don’t have the answer to that right now.

So you have to do a clinical study to better understand exactly what we’re doing. I think the other question was about biopsy.

And if you don’t mind, could you ask that again, I’m not exactly sure of that.

Unidentified Analyst

I was just wondering if you see a sort of a stabilization of the types of cells and the value – the volume of cells within biopsy samples over a period of time and whether that – you see that occurring at, say, three months or six months or something later than that even, because it would seem to me that if you do so the stabilization of the cell populations within a certain period of time. And they remain such thereafter for a reasonable period of time then that would seem to indicate that you have established a very stable product actually in place.

Jim McGorry

Yes, thank you for clarifying that. I’ll turn it on over to Saverio who can comment a little bit further, but what I’m trying to be able to show those different time points, we will be doing cell fate studies.

We are doing further studies of what are those exactly cells in the characterization; what different proteins and cytokines are up and down regulated to the definition of mesenchymal stem cell. What I’ve commented earlier is, it is amazing.

We’ve seen continuous regeneration that follows the same form. At day 21, the connective and vascular tissue – we are characterizing those cells.

Saverio was further using OCT, optical coherence tomography. I feel very impressed because I just learned to say that last week, a very near infrared technology to be able to have not a biopsy but the animal alive in going down with the scope and being able to show cell type along the way.

So we are doing a number of things that show the stability of the cells, the stability of the regenerated, reconstructed esophagus of what that is. Now let me just please turn it on over to Saverio for any further comments.

Saverio?

Saverio La Francesca

Thank you, Jim. So I think Jim already answered the question.

As we are going to follow on the cell fate and that is the fate of the cells that we see this scaffold with. Surely we are clear and I understand the question, the cells that we see this scaffold with are not cells, they are going to differentiate in the layers of the esophagus.

So when we are talking about stabilization into that population, maybe we want to make clear that we don’t expect for those cells to differentiate in any layers. That’s all what we know right now about adipose-derived mesenchymal stem cells.

So they can probably, partially be part of the new tissue [Audio Dip] see this scaffold with are simply glittering the healing response of the body. And having frequent response from the cell, niche that is present in the native of esophagus.

And therefore the layers that we are seeing in the regenerative tissues are – if you were already stable as in they come from the original stem cell niche and they differentiate in the relevant layers. So one more time, our cells we don’t expect for them to differentiate particularly and therefore we don’t expect to see any stabilization.

Unidentified Analyst

Interesting. Okay, thank you.

And then I was just wondering if you might be able to give us an a little bit of an insight into the types of end points if you will that you’ll be monitoring in the patients in the Phase 1 clinical trial.

Jim McGorry

Thanks. The key points are safety and feasibility into the Phase 1.

We have some endpoints that will go over those different time points at time of stent removal and at different periods, but it’s safety and feasibility. We’d be doing in further areas to be able to highlight the functionality also.

Unidentified Analyst

Right, I appreciate that. But I was wondering if you might be able to tell us, are you going to – is it even feasible to do a biopsy at a point or two to evaluate or use your OCTs viewing system to assess the status of the cells.

And also to – if you are going to do something like measure cytokines as well, I just wondered.

Jim McGorry

Yes, thanks very much. I will turn it over to Saverio.

We have a number of areas to be able to better understand that mechanism of action to better measure that cytokine response at different time points. I believe that the biopsy – and we talked about the biopsy a lot, but we believe that also by taking a biopsy you are affecting the regenerated area and actually influencing that along the way.

That is why we chose a less invasive area within OCT. Saverio, your comments towards additional visibility during that Phase 1 study.

Saverio La Francesca

Sure, thank you. First of all, as Jim said, we are accessing safety.

So maybe if I can for a moment to rewind here; so as Jim said at the very beginning, the current standard of therapy is having in your chest or a piece of your column in your chest. So you have a very much passive clung to it that doesn’t belong in the chest and also have different anatomy and different size of virtue esophagus is.

So what we are trying to do here at Biostage is to have an alternative conduit. It allows for the passage of food without having to do what I just described.

And without having hopefully the complications that having your stomach or your column in the chest, you have the possibility of the course, and that’s what is our animal model is giving us. We have no incidence or licks, no incidence or infection.

And the animals are now in their eight months or nine months, they are not in a cage, they are on a normal bedding, and they had gained weight. So they had to return if you go to a normal life.

And this is also an animal model where obviously being a quadruplet, the esophagus is horizontal as opposed to being vertical, so gravity is also not helping. That is what the most important thing.

So we will be following the animal with like Jim said, optical coherence tomography as we have been doing and that has been showing that with time we see our differentiation in the relevant layers of esophagus. But for the time being we need to make clear that we’re looking for a safe alternative conduit, that is not the stomach or in the column and it allows for the safe passage of food.

Unidentified Analyst

Very good, thank you so much.

Saverio La Francesca

Thank you.

Operator

Thank you. Our next question comes from the line of Jason Kolbert with Maxim Group.

Please proceed with your question.

Jason Kolbert

Hey guys, I’m a little bit confused by some of the questions that you’ve been asked, and Saverio, thank you for the explanation. We should all understand, right.

These are mesenchymal cells with exerted trophic effect. They don’t differentiate.

And the trophic effect itself is essentially accelerates the healing process versus the scoring process on the graph. So the entire line of questions, don’t make sense to me.

I’m sorry, I just don’t get it, but I do understand your answers. What I want to focus in on, as you mentioned the fact that a potency assay is going to be required by the FDA before you can go into the clinic and MAN.

And my question is you’ve already been in MAN with the gen-one graph. So I’m not sure I understand why the FDA would be pushing you for a potency assay.

And what where the release characteristics of such an assay look like? That can be a very tricky thing.

And you did mention a little bit about the fact that you’re going to have one-year safety follow-up on the animals. Did I understand Jim you to say that since you have some animals out the nine months that those same animals can be used to satisfy the one-year requirement, where I’m trying to drill towards which is what I think the other analysts are trying to drill toward is when do you think you’re actually going to implant the first graph in MAN in U.S.

under an FDA protocol? Thanks.

Jim McGorry

Great comment, Jason, and thanks very much. What we – I mean if you – yourself and do you know kind of a key expert in regenerative medicine, it’s sometimes a complicated piece.

We found ourselves trying to educate a number of people even after the FDA around the paracrine effect, the cell signaling effect, the healing fact of the body healing itself which is the basis of our product. And so that’s exactly right.

We are better understanding that mechanism. We’re seeing that in a way.

But the other amazing thing that we’re seeing into our technology is as you know for 20 years or 30 years, tissue engineering and regenerative medicine was vascularity, angiogenesis and incorporated into the scaffold. And for us now with having a removable scaffold and only a biologic response to be able to make that alternative conduit is really a sort of unique piece that we have.

We work with the agency to bridge from that data originally on our gen-one product, where we had a pre-IND in January 2014. And so we are bridged from that.

The FDA recognizes now our combination therapy, our biologic, and particularly at biologic by having a temporary scaffold. And so with that we’re continuing and that’s why we had two of the key mesenchymal stem cell expert Dr.

Balber and Dr. Cox to be able to help us with that key potency assay and those release criteria.

And so as you know that’s big pieces from the agency. The agency has not said that we need to have this out, Jason for a year as year post.

We are trying to be able to work with them to be able to say, okay, what is the appropriate period post 180 days that you’ll see the stabilized regeneration and nose to noses from this area. And we’re continuing to be able to work.

Sometimes we see that as 120 days and we have seen that. And we will use as in our basis of filing those different animals that we have out at eight months and nine months as proof points into that larger area.

Your question and two other analysts to be able to say, when will we see this technology back in demand. We believe that transformative moment will be Q4 2017.

Jason Kolbert

Perfect. Thank you so much for the follow-up.

Jim McGorry

Thank you.

Operator

Thank you. Our next question comes from the line of Brian Brennan with National Securities.

Please proceed with your question.

Brian Brennan

Yes, good morning. Thanks for taking my questions.

A lot has been covered here. I just wanted to circle back to the bronchial and maybe even a little bit on pediatric atresia.

Am I correct to assume that, pause me, those IND has been pushed out a little bit. I know we’re focusing on the esophageal.

But can you maybe give me a little color on what were you filing on the IND on the bronchial and as well as I noticed the pediatric atresia got pushed into 2018.

Jim McGorry

So, thanks Brian. As you know cash is king for us right now too and we need the fact of the matter we’re very focused to be able to advance our esophageal implant.

We really believe that with the approval and the filing and the movement in demand the value of this company is going to be transformative from where it is right now. And so with that that is really our focus.

We do get a lot of interest into both the bronchus and pediatric and esophageal, particularly in this pediatric area because there’s not a lot for these kids. I think Saverio is doing a bronchus case today and stepped out of one at Mayo Clinic.

And so we did move which I had into 2017 originally, we did move the pediatric piece, the pediatric IND and esophageal atresia back into 2018. We will probably move the bronchus piece back, but we’re going over that cash position where we stand in better understanding that.

But please note Brian we continue to be very focused, seen it as a platform, but also focusing on first things first.

Brian Brennan

Excellent. Regarding the Connecticut Children’s and you guys are doing some work with them, pre-clinical stuff.

Will we able to see maybe some data – sometime in 2017 with regard to kind of how that collaboration is moving along?

Jim McGorry

Saverio, thank you very much. Saverio – he has been in constant contact with Dr.

Christine. I think, Saverio, would you like to comment around Connecticut Children’s?

Saverio La Francesca

Thank you, Jim. The answer is yes.

Some of the animals had been going on in 2016 and we have more animals that we are planning to do. So we are also developing a specific model size-wise to be and reflect a real close lesions of esophageal atresia as you know there is no large animal model for esophageal atresia.

So we are actually using very small animals a lot more time. The model is always ultimately big that reflect weight-wise what will be almost a new born.

So I doubt that it would be certainly a developed one to talk in 2017 and needless to say we move I don’t have a date but that’s what we do. And that’s why we have the collaboration Jim alluded to.

This collaboration are fundamental because they allow us to not only if you will have the brainstorming with the scientist, but they give us the main power that we don’t have. So we can conduct those experiments without being losing focus on our current product which is the esophageal for adults.

Brian Brennan

Excellent. And just a follow-up on that.

I know there has been some talk positively on compassionate use study. I know it’s sort of out of your hands but can we – can you guys comment a little bit on maybe the progress there if there’s anything further details with that.

Jim McGorry

Thanks. I think Brian that we are just seeing ongoing.

The more meaningful data we produce the more continued interest that we have. Saverio and I will be in front of the Society of Thoracic Surgery in the 2017, the American Academy of Thoracic Surgery meeting both in January and in May.

And with that, I know the interest that pops up from – at Boston Children’s, at the great MD Anderson, at Mayo, at UT, at Cincinnati Children. There’s a lot of people that are watching our data and trying to find that area.

So we will continue as we build our IND package, the opportunities for our compassionate use are open. However our focus is to get the clinical into that and if that right patient at that right time in that right area we will evaluate that, but that is driven by a hospital interest and not us as a company interest.

Brian Brennan

Understood. Okay, great.

Thank you.

Operator

Thank you. There are no further questions at this time.

I’d like to turn the floor back to management for closing comments.

Jim McGorry

So thank you very much. Great questions and I hope that you feel that we have line of sight on the issues.

We’re addressing the issues up front. We’re making material progress.

We thank you. We’ll keep you informed of that progress going forward.

We believe that we will get our financing. We will do that at the right time.

We’ll continue to develop this meaningful data and keep you informed as we go forward. Thank you very much.

Operator

This concludes today’s teleconference. You may disconnect your lines at this time.

Thank you for your participation.