Good morning. And welcome to the Discovery Labs’ Fourth Quarter and Full Year Business Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. Please note this event is being recorded.

I would now like to turn the conference over to Will Roberts, Vice President of Investor Relations. Please go ahead, sir..

Thanks, Dan, and good morning to everyone joining Discovery Labs call this morning. Today’s call is to discuss our 2014 fourth quarter financial results, as well as recent business updates. Before we begin, I will remind you that today's conference call will contain forward-looking statements.

These statements relate to future events or the company's future financial performance.

Such statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from any future results expressed and/or implied by these statements, especially those inherent in the process of discovering, developing and commercializing our products.

The listener is cautioned to not rely on these forward-looking statements, as actual results could vary materially from those described as a result of a number of factors, including those set forth in our 2014 annual report on Form 10-K and any subsequent SEC filings.

On the call with me this morning and available for Q&A after the call are John Cooper, our Chief Executive Officer; Steve Simonson, our Chief Development Officer; and John Tattory, our Chief Financial Officer. And, with that, I'll turn the call over to John Cooper, our CEO.

John?.

Thank you, Will, and good morning, everybody. Thank you first of all for taking your time out to listen to the call and get up-to-date on Discovery Labs progress. So, first things are, we issued a press release yesterday after the close, we filed our 10-K.

And without a question, when you read the press release, there is a word that’s sticks in there and I think that word ultimately is called transformation. We are -- the theme is, we are adjusting the strategy of our company to a certain degree. Let’s start first, as Will mentioned, it is a financial call. It’s a business update call.

So let’s deal with the financial issues first. We have $45 million of cash on the balance sheet beginning this year and we have experiences that we have so far that we have learned from and that we need to apply, I think, to make good sound prudent business decisions.

Our goal is to allow that capital to be invested in a smart way, so that we can ultimately benefit all stakeholders to the best of our ability with the use of that existing capital and ultimately, that’s what’s happening here, and I want to put some stuff in context first. I want to go back about a year ago.

A year ago this company went through a transformational event and the fact that we had SURFAXIN that we were launching into the NICUs across the United States and we began a clinical trial for AEROSURF.

AEROSURF is viewed by many, whether it be within the medical community or the corporate community or the financial community as a very, very exciting product, one that could ultimately using the word again transform the way children, premature infants, are being addressed with respiratory distress syndrome and we embarked on that journey a year ago with those areas.

A lot of things have taken place since then. A lot of learnings, a lot of things that are exciting, a number of things that are frustrating, but through that process, one thing we know we need to do is learn by it and adjust accordingly.

So with that said, we have a very, very key belief that our surfactant technology and our aerosolization technology, we consider to be in our opinion the best in the world.

What we have done many, many, many years ago, through the saga of SURFAXIN, as well as in other indications is our surfactant has been in a number of patients, our surfactant has been in premature infants, our surfactant has been in babies and infants with acute respiratory failure, our surfactant has been in adults with acute respiratory distress syndrome.

And one thing we see over and over again is that we have a drug that we have confidence in. Number two, what we also see over and over again, and in our belief is that, if only and this goes back years ago, we thought if only we can aerosolize that surfactant and apply it to those patients who would benefit from not having to be incubated.

And so what’s happened in this last year. First with AEROSURF, I recognized, we as management recognize that enrollment has been slow and it is relatively frustrating right now that the data from our Phase 2a program is not on the table as we speak here today. But I will say we are close.

We are coming to the conclusion of this trial and we anticipate having that information available to people shortly and we are excited about what we are seeing. We are very excited about the experience that we have so far. Dr. Simonson will take you through in a minute or two what our learnings are.

But it is those learnings, both with the drug, the ability to know that that drug is finding its way into the lungs of very premature infants with respiratory distress syndrome, our belief that if drug can get to the lungs using our system of a premature infant, one would argue, it can be able, we should be able to do that in other patients with respiratory diseases as well and the arrangement that we have with Battelle and the development of our device technology is moving and progressing very well and the experience that we have with our device technology is very, very important and allowing us to make the moves that we have articulated in our press release and 10-K from yesterday.

So there is a real good sense of excitement and confidence to-date with what we think so far in AEROSURF. Now, with that said, with respect to SURFAXIN we have always believed and we still believe that one day in the future SURFAXIN and our technology KL4 surfactant will be the dominant surfactant in the NICU. Our issue is time. Our issue is resources.

Our issue is muscle. And as you see in the press release, we indicated that we are assessing strategic alternatives regarding SURFAXIN. I know both with AEROSURF and SURFAXIN, we will have a lot of questions later in Q&A. We will get into those things of course.

But the main thing what we expect with SURFAXIN is back to what I said earlier, we need to adjust. So far in -- well, in 2014, our net investment for SURFAXIN was $19 million. Go back to the beginning of the discussion where I mentioned, we start this year with $45 million.

That is becoming very obvious to us is that we need to find and work with a partner who has the ability to bring SURFAXIN into their capabilities with their resources, with expertise in the hospital and really give SURFAXIN the push that it deserves.

We have a very good group of people who understand what SURFAXIN is also about and the way to ultimately make it successful in the hospitals that we currently have SURFAXIN in. And that group of people have done a fine job but we need more of them and we need more resources behind the product.

I do believe that if those resources are invested that in the mid-to-long term, there is an annuity value associated with SURFAXIN from the conversion of hospitals from animal-derived product to KL4 synthetic surfactant. So what we have -- so what we have begun -- I shouldn’t say begun.

We are in actually in advanced stages of discussions with strategic partners. And we are moving in the direction where we want to and our goal is to in the very, very near future, ultimately bring a strategic alliance regarding SURFAXIN to a close and that is our ultimate goal.

That is what we’re looking to accomplish and we anticipate doing that properly. Now with that said, there can never be any assurances. Everybody knows that strategic alliances have their twists and turns and while we have confidence and while I mentioned earlier, we are in advanced stages of those discussions there are no assurances again.

And if for whatever reason, we cannot bring a strategic alliance or collaborative arrangement to a close then the most likely scenario after that would be an adjustment on our side as difficult as it would be given the history and given our belief but as difficult as it would be to cease then the commercialization of SURFAXIN and put our resources behind the theme of aerosolized KL4 surfactant for respiratory diseases with a focus on making AEROSURF the first product out of that pipeline and being a -- with the goal of being very successful with that product.

That’s what we’re shooting for, very excited about that. So just to summarize real quickly before I pass it on to Dr. Simonson, $45 billion in cash, we are very conscious of utilizing that capital and stretching that out as long as possible in order to see milestones and success associated with our primary program which is AEROSURF.

We are adjusting our organization. We are adjusting our strategy around that theme. We believe success with AEROSURF will also allow for capabilities to look at other respiratory disease where synthetic aerosolized surfactant could help babies. We are looking at strategic alternatives right now with SURFAXIN.

Our goal is to have a partner with SURFAXIN with the bustle and resources to ultimately be successful with SURFAXIN. Our goal is to bring that to a close very, very quickly. And again, given the fact that there is going to be no assurances because again nothing is done until it’s done.

If for whatever reason that can happen, we will then adjust to focus on the aerosolized portion of our business and then ultimately cease the commercialization of SURFAXIN. How painful that is with respect to all the efforts we’ve made today? With that said, I’ll be available for Q&A. I’d like to pass the discussion over to Dr.

Simonson to get into more in-depth overview of AEROSURF..

Thanks John and good morning everyone. As you saw from this morning’s press release, based on the recent rates of enrollment into our ongoing phase 2a trial and the projections we’ve recently done, we expect to complete the study late this quarter or early in the second quarter.

However, in the interest of being transparent and also to begin to ship the kind of data we are seeing, we decided to provide more detail than we provided before and then look forward to full data release in the near future. I’ll start with a summary of where we are.

First enrollment has taken longer than we anticipated but we are close to the end of enrollment in our third dose group and understand many of the reasons why this has been slow. And as you will hear momentarily, we are making adjustments to the next phases of the program to have a different enrollment experience going forward.

Second and importantly, the safety and tolerability profile of AEROSURF continues to be similar to the nasal CPAP group. From a program and drug development perspective, that’s where we need to move forward and this trial continues to create a good foundation, upon which we can build the remainder of the program.

From our perspective, we also want to see evidence if the drug is getting into the lung. And thus far, I’m confident that what we’re seeing if the AEROSURF babies to date is consistent with achieving that goal. Based on the progress on these three factors, we are moving the program forward to the next stage.

Let me review some of the design elements of the ongoing study. This is a multicenter escalating dose study evaluating three doses of increasing amounts of aerosolized KL4 surfactant, delivered three nasal CPAP compared to a controlled group of nasal CPAP alone. There are eight active and eight controlled babies per dose group.

Babies are getting a single dose and we follow them during their NICU course. We are conducting the study in preterm infants 29 to 34 weeks, gestational age. With diagnosed respiratory distress syndrome, we are receiving nasal CPAP. These babies have been required to have a significant oxygen requirement to be included in the study.

The trial includes 48 babies. Excuse me.

And as a reminder, this trough size has been increased by about a third over the last year to increase the number of control babies, primarily to make the study more robust and to match the controls one-to-one to the AEROSURF babies to better assess safety and tolerability, as well as characterize the controlled groups more completely.

The primary objective of this first trial is an assessment of safety and tolerability for the single dose of aerosolized KL4 surfactant. We can move on to the next trial, as long as the study shows adequate safety and tolerability of AEROSURF, compared to nasal CPAP alone.

And with only a small number of babies yet to enroll, we are confident in that regard. A secondary objective of this study is to obtain psychological evidence that the KL4 surfactant is getting to the lungs of these infants and doing what it needs to do. The third objective is to gain experience with the aerosol device and evaluate its performance.

To assess safety and tolerability, we are looking at those like treatment failures, adverse events, serious adverse events, complications of pre-maturity. Evidence of the drug is getting into the lungs comes from how much oxygen the babies required called FiO2 and how effective the lungs get rid of carbon dioxide.

And our third objective of the device performance has been assessed by internal device controls as well as investigator reports. Regarding our first objective, we’ve had two successful reviews by our Independent Safety Review Committee, after each of the first two dose groups and enrollment is now well underway in the final dose group.

As I mentioned earlier from a safety and tolerability perspective, the AE profile for AEROSURF appears similar to that of controls.

On the third quarter conference call last year, we discussed the rate of air leaks specifically in pneumothoraces inside of the small numerical difference in the number we had seen in babies on AEROSURF, compared to babies on nasal CPAP alone. As an update, we’ve seen additional air leaks since that call but only in the control arm.

So at this point, we see no difference in the rates of air leak between AEROSURF and control babies. And I will remind you again that good, safety and tolerability data, assuming they play out through the last part of the study, it is the central outcome to move on to the next phase of assessment.

Regarding our second objective, I know it’s premature to present data until we finished the study. I want to comment briefly on what we are seeing, as it relates to physiological evidence of delivery of drug into the lungs of these babies.

The FiO2 or fraction of inspired oxygen is one of the ways we assess how well the lung is functioning to oxygen in a blood. The air we breathe has 21% oxygen. Blood oxygen saturations in a protocol and clinically are maintained between 88% and 95%. Babies with healthy lungs can achieve this breathing room air.

Babies with RDS require supplemental oxygen to maintain their blood oxygen levels in the desired range. And the babies in our trial require at least 25% oxygen. The supplemental oxygen can cause unwanted side effects, so care providers try to decrease the amount of supplemental oxygen these babies breathe as quickly as possible.

In AEROSURF babies, we’ve told you in the past that investigators are describing them as pinking up and breathing easier after treatment. We are now seeing that the amount of oxygen these babies require is less as well and this is an important sign of clinical improvement.

RDS babies frequently have increased values of carbon dioxide because the lungs don’t work well. And we are seeing decreases in carbon dioxide values in AEROSURF treated babies, another sign that the lungs are working better to get gases in and out of the blood. In summary, we are indeed seeing the meaningful impact on these important measures.

And we are seeing these impacts happen quickly after treatment begins. Again, we are not finished with the final one yet but thus far, data are encouraging. Regarding our third objective, the device itself is working as expected and the investigators utilizing the device are having a very good experience with it.

When we look at the sum of this data, along with the experiences of our investigators, we’ve made the decision that we are advancing to the next stage. First, we are preparing ourselves to perform a safety study in younger gestational age babies, 26 to 28 weeks. And we are going to start that upon completion of this third dosing group.

And we’ve already begun our startup activities, including additional sites selection and investment in devices and trial infrastructure to prepare for the planned phase 2b study that is plan to include 26 to 32 week gestational age infants, which we expect to conclude in the first half of 2016.

Let’s come back to enrollment, both our experience so far and how we are addressing it in the next phase. The current study is the first study of this new treatment paradigm using our drug device combination to treat RDS. It’s appropriate that inclusion and exclusion criteria are somewhat restricted to select the proper babies for a first study.

There is no doubt that this has been an important part of our recruitment situation. We are currently studying 29 to 34 weeks gestational age babies with RDS, and we’ve had an oxygen requirement for these babies and some marker-up severity of RDS.

Many babies in this age are less surfactant deficient than younger babies and they don’t have that oxygen requirement. So these babies frequently don’t qualify for our study.

Furthermore, we are finding that many of the babies in this age remains either move to improvement and no longer needs supplemental oxygen, or to declare themselves as having significant RDS and need intervention. And therefore, many of these babies do not qualify for our study.

We are trying to enroll babies in between these extremes and it has been a challenge. They were finally reaching the end of enrollment in this study. We anticipate that the burden of these first study requirements will decrease as the program moves forward.

To that end, an important question is what will be different in the 2b that gives us confidence that we can hit our timeline. Here are some of the considerations. First, we have a better estimate of the number of sites that we will need based on our clinical trial experience to-date. We plan to have approximately 30 sites in the U.S.

for the 2b study and half of those were already be up and running in other parts of our program. So startup times will be greatly diminished. Second, we have modeled recruitment using the rate we are seeing in the current trial, and this is a very conservative estimate for all the reasons I discussed earlier.

In addition, the 2b study will be including the younger babies 26 to 28 weeks gestational age. So the allowable age range will be expanded significantly increasing the potential pool of babies for the study. Furthermore, the younger babies will be more likely to meet inclusion criteria. Third, the 2b study will include sites outside the U.S.

This will provide access to some very large birth incentives with clinical research experience. Fourth, some of the inclusion criteria appropriately required in the first study maybe modified in ways to facilitate enrollment. And finally, and maybe most obvious, the data from the 2a program remains as compelling as what we are seeing now.

This data will generate enrollment excitement in and of themselves. We are looking forward to completing the last very few patients in the current study and reporting the data in the coming weeks. With that, I will turn the call over to John Tattory for a quick financial update..

Thanks, Steve. And good morning, everyone. I am going to provide you with a brief overview of our fourth quarter financial results and I will be happy to provide additional details during Q&A if needed.

During the fourth quarter of 2014, we recognized $1 million in grant revenue for continued developments of our pipeline of aerosolized KL4 surfactant opportunities. We received $700,000 under a $1 million SBIR Grant from the NIH to support the development of aerosolized KL4 surfactant as a medical countermeasure and radiation-induced lung injury.

Over the next two years we maybe awarded up to an additional $2 million as part of this grant. We also received $300,000 under a $1.9 million Fast Track SBIR Grant from the NIH to support the ongoing AEROSURF Phase 2a clinical trial.

Additionally, for the fourth quarter of 2014, we recognized $136,000 in revenue for sales of SURFAXIN, compared to $106,000 recognized in the third quarter of 2014. Our operating expenses for the fourth quarter were $12.4 million. And the components of these expenses are as follows.

Approximately $4.5 million were expenditures to support manufacturing, quality, medical affairs and commercial efforts to support SURFAXIN. Under the strategic alternatives currently being considered regarding SURFAXIN, we expect these expenses could be greatly reduced if not completely eliminated.

We also continue to fund our AEROSURF development program through key investments in internal R&D operations to support clinical trials and device development activities, cost to conduct our ongoing Phase 2a study and cost to manufacture capillary aerosol generator devices and preparation of the Phase 2b trial, cost related to our collaboration arrangement with Battelle to develop a Phase 3/commercial capillary aerosol generator, and finally cost to execute the NIH funded study and the utilization of aerosolized KL4 surfactant and radiation-induced lung injury.

Overall for the quarter ended December 31, 2014, we reported an operating loss of $11.2 million compared to $10.3 million for the comparable period in 2013. Regarding our cash position, net cash outflows before financing activities for the fourth quarter were $10.2 million. As John mentioned, we ended 2014 with $44.7 million.

And as a result of the strategic alternatives currently under consideration, we are now forecasting net existing cash is sufficient to fund our operations through the first quarter of 2016.

As a reminder, we currently have $30 million outstanding under a secured loan facility with Deerfield with repayment due in three equal annual installments of $10 million beginning in February of 2017. The 2017 and 2018 installments maybe deferred if we achieve certain financial milestones.

I will now turn the call back over to John Cooper for closing comments..

Thank you, everyone. I think the thing we should do right now is go right to Q&A. I know people have a number of questions. And again, our theme is we need to adjust. As you can hear through what Dr. Simonson said, we have a lot of confidence in the way our technology is moving forward.

And when you think about the markets that that technology could be applied to, when you think about the size of those markets, when you think about the fact that with success in development, those medical opportunities would be first-in-class with a lot of capabilities to create medical and economic value, and given what we are doing as well with our capital, I think with the moves that we’re making make all the sense in the world for what we need to do.

And last but not least, SURFAXIN is a wonderful product. It saves lives. And we are working hard to keep that product alive and to make sure that it apply itself in the hands of a team that can bring the commercial and medical push to making that successful. That’s our goal. With that said, send it over to Q&A please..

[Operator Instructions] And our first question comes from John Henry of ROTH Capital. Please go ahead..

Hi. Good morning. It’s Scott..

Hi, Scott..

Not sure where to start, a lot of questions. But I guess, I’ll get started with the $45 million in capital you have currently.

Are there any covenants on that? I mean, given you have the debt, I mean can you spend all $45 million of that? And how long would you expect that to last?.

Scott, we’re forecasting right now based on the alternatives that we’re considering with SURFAXIN that that would last us through the first quarter of 2016. And there are no covenants under the Deerfield arrangement regarding that..

Okay. Thank you. And that’s helpful. And either shifting to the SURFAXIN I guess out-licensing or whatever you want to call it.

If you did a deal, would you expect getting upfront payment on that or would it be more likely to be some sort of earn-out royalty structure?.

Hey, Scott. It’s John. I would rather not get into what we think those terms could be. I mean, we’re going to try to maximize everything as possible. That’s what we will try to do, maximize as much as possible. So should we find ourselves with success in that arrangement, then of course we’ll be announcing that and talking about it.

But we want to ultimately maximize the capabilities and the value of that product..

Okay. And when I think about the income statement pulling that out, I know you used this $4.5 million a couple times. But it would seem to me like you could save even more than that because if I look at my model, you’ve got about $5 million in for sales reps and then you get the medical liaisons.

What do you think would be the all-in expenses per year that you could pull out of the model by selling that product?.

Scott, it’s John Tattory. The numbers we’ve given you are all-in. So the $4.5 million for the fourth quarter included manufacturing, quality, supply chain, medical affairs, commercial, all-in, as well as the $19 million we had indicated for the full year of 2014..

Okay.

So you’re talking about pulling $4.5 million per quarter out of the model?.

Yes..

Okay. All right. That makes sense. Thanks for that clarification. And then I guess on AEROSURF, I mean it sounds like this 2a, it’s pretty much an open label trial. So, I mean, I’m not sure exactly how far you are into it, but you’re almost far enough into it that would you consider that a successful trial, –[indiscernible] it’s open label.

You’ve seen it. You’re far enough along to make your assumptions.

Is that a fair statement?.

It is an open label trial and that does allow us to see some of the data that’s generated as the trial progresses. And it’s – the trial is not over but what we’re seeing is very encouraging and points to a successful outcome..

Okay. And I guess the final question.

Any opportunities to partner AEROSURF over the next 12 months, perhaps outside the U.S., have you thought about that or anything that we would see as validation of the success of that program?.

Well, have we thought about it? The answer is, yes. We have relationships with a number of companies that have interest in AEROSURF. The question will always be, when will somebody want to partner? When will somebody want to take on the program? Some people have a risk appetite that is less. Some people have a risk appetite that is more.

Some people may want to wait until Phase 2b data is available and some people depending upon the Phase 2a experience may have an interest in AEROSURF from post Phase 2a. I can’t sit here and say whether something is going to happen within the next 12 months.

The only thing I can say is, it’s our job to be active on the business development front, know those companies that have an interest in this field and articulate our story, articulate our capabilities, make sure that they are as educated as possible, so that one day should that happen, people are already including us.

So we are active and it’s part of our assignment..

Okay. Thanks. And I had just one last question with regards to SURFAXIN in the launch process. Were there ever any opportunities to discount that product to try to get faster uptake into the hospitals? I’m just curious how that went..

Yeah. There are opportunities. But I think you want to be very careful in that market, because it’s not like AEROSURF that would be assuming success and given the competitive position where should it become the first in the market you have an ability to establish the economic value.

The animal derived products have discounted themselves year after year after year after year, to a product that saves the life of a child. So what we’ve done is competitively priced the product so that price does not ultimately get in the way..

Yeah. I think that makes sense. Well, thank you very much for taking the questions..

Thank you, Scott..

Our next question comes from Tom Shrader of Stifel. Please go ahead..

Good morning..

Good morning, Tom..

[Indiscernible] we’ve talked for a long time about SURFAXIN paving the way for AEROSURF, and then that’s a compelling argument.

Does it make sense to try to license -- to out license only one product or do you think, what are your thoughts there, you’ve kind of unlinked what we talked about for a long time?.

The answer is for us at this time, we do think it makes sense to do it in that way. We think that given our confidence in our abilities, we believe to advance AEROSURF, there’s more value for AEROSURF. And so the question is at what point in time do you ultimately find a partner and link the two.

And hopefully one day there’s an opportunity that they can be linked. But first step -- the first step will be SURFAXIN along with the possibility of the next generation of SURFAXIN which will be the lyophilized dose, SURFAXIN LS. That’s our thinking.

We are starting with one and with respect to AEROSURF generate what we would believe to be the proper value for it..

I don’t know if you’ll comment, but have you ever been in late stage negotiations to out license SURFAXIN over the years early on?.

Many, many moons ago, back in 2004, 2005, we had opportunities, but -- well ultimately what we did was we made a decision to commercialize it ourselves. So that’s the endeavor we went on up until the decision that we are making now..

Okay. And then the last question is a little complicated. So in the big AEROSURF trial for the current AEROSURF, why are there so many controlled patients.

I mean isn’t it just nasal CPAP for different amounts of time, not sure why you need a controlled group each time and going into that, has there -- because it’s the same dose for just longer time as you dose, is the timing in the third leg just getting too long, is that’s why it’s hard to enroll?.

The short answer is no, but the reason that we increased the controlled group is in a safety and tolerability study, you’ve got to compare -- you’ve got to have a robust reference group to compare to.

And one of the things that we’ve mentioned in the past is that in these older babies 29 weeks to 34 weeks, who have an oxygen requirement, there isn’t a lot of information on this population out in the literature and kind of what our program is doing is kind of raising a trail to describe the characteristics of those babies.

And in that setting, it always serves you well to have a very solid controlled group upon which you can make comparisons and so that you don’t get misleading impressions of your data because you just haven’t studied enough babies.

And you are right that the aerosol generator that we have, we are dosing it in three groups where the amount of surfactant that we give to these babies is dependent on the amount of time that they are being exposed.

But we are not seeing anything in the trial that says that at the third dose group that we are administering it for too long, in fact, quite the contrary..

And is there any attempt by the Battelle to increase the same dose per time that part of what they are working on?.

We are working very closely with the Battelle to try to optimize many of the features of our aerosol delivery technology and that includes being able to administer over various dosing regimens either changing how much we give over time or as well as making the device as efficient as possible..

Okay, okay. Thanks a lot..

Our next question comes from Michael Tung of Turner Investments. Please go ahead..

Hey, guys. Good morning.

I was just wondering is there any -- was there any other sort of indicators, sort of maybe time to when the babies need to get on a ventilator that you guys sort of saw with regard to the control group versus the AEROSURF group because one would think that if the drug is getting the lungs, the time until they actually need to be put on a ventilator would be would be increased I would think?.

You are exactly right. Again, this is a single-dose study. And one of the parameters that we are looking at is the -- what happen to these babies over there course and the time in those babies who have acquired intubation, the time to intubation or rescue therapy has been prolonged as we’ve grown up on the dose groups in our trial..

Okay.

So when we get the final data of this all, it will be laid out, there’ll be numbers and you have to put some numbers around this?.

Yeah..

Yes, we will..

Yeah, we will..

Got it. Okay. And then just to reiterate, I think, as I went through the K last night, it sounded like you guys would have data -- I think you said early. I just don’t have it in front of me.

So early would imply before mid quarter, so say the first half of the second quarter just because it has been delayed three times, I mean just to be fair?.

That’s a fair question, a fair statement and the answer is that’s what we believe, that’s correct. We indicated early second quarter..

Okay. Great. We will stay tuned to the data. Thanks a lot..

Thank you, Michael..

This concludes our question-and-answer session. I would like to turn the conference back over to John Cooper for any closing remarks..

Thank you very much. It’s been a 45 minute conference and I know everybody is busy. So, I wanted to say thank you so much for your attention to the details. And call us at any point in time, if you want to follow-up with us about any topic and I wish everybody a good day. Thank you..

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect..