Coronado Biosciences' CEO Discusses Q4 2012 Results - Earnings Call Transcript

| About: Fortress Biotech, (FBIO)

Coronado Biosciences, Inc. (CNDO) Q4 2012 Earnings Call March 14, 2013 8:30 AM ET

Executives

Lucy Lu - EVP & CFO

Harlan Weisman - Chairman & CEO

Analysts

Ian Somaiya - Piper Jaffray

Joe Pantginis - Roth Capital Partners

Megan McCloskey Dow - MLV & Co.

Christopher Marai - Wedbush Securities

Operator

Good day, ladies and gentlemen, and welcome to the Coronado Biosciences’ Fourth Quarter and Year-End 2012 Results Conference Call. At this time, all participants are in a listen-only mode and later we will conduct a question-and-answer session, and instructions will follow at that time. (Operator Instructions) And as a reminder, this conference is being recorded.

I would now like to turn the call over to your host today, Lucy Lu, Chief Financial Officer.

Lucy Lu

Great. Thank you, operator. Good morning, everyone. This is Lucy Lu, CFO for Coronado Biosciences. Thank you and welcome to our fourth quarter and year-end 2012 financial results conference call.

Before we begin, I would like to remind everyone, that various remarks that we make on this call will contain forward-looking statements, including those regarding the timing of clinical trial initiation, enrollment and results, potential future clinical trials, the therapeutic and commercial potential of our product candidates and their regulatory pathway, intellectual property position, our manufacturing, supply and other collaborative arrangements and the sufficiency of our cash resources.

Forward-looking statements involve risks and uncertainties that could cause our actual results to differ significantly from those projected. Additional information concerning these risks and uncertainties is contained in the Risk Factors section of our quarterly report on Form 10-Q for the third quarter ended September 30, 2012 and our annual report on Form 10-K for the year ended December 31, 2012 and in the company’s other filings with the SEC.

With that, I would like to turn the call over to Dr. Harlan Weisman, Chairman and CEO of Coronado who will begin the presentation after which I’ll provide you with the summary of our financial results for the company. Harlan?

Harlan Weisman

Thank you, Lucy and thank all of you for joining us this morning for Coronado Biosciences’ earnings call to discuss the fourth quarter and year-end financial results for 2012. With me on the call today in addition to Dr. Lucy Lu is Dr. Bobby Sandage, Coronado’s President; Noah Beerman, our Chief Operating Officer and Dale Ritter, our Chief Accounting Officer.

Before I provide an update on the development of our various programs I would like to take a few moments to introduce myself to those of you who I have not yet had the opportunity to meet. As you may know I joined Coronado in August of 2012 as a member of the Board of Directors and in January 2013 accepted the position of Chairman and CEO. Before this I spent over 20 years at Centocor and Johnson & Johnson where I participated and led the development and regulatory approval and launch of novel biologics such as REMICADE which are used for the treatment of autoimmune diseases including Crohn’s disease, ulcerative colitis, psoriasis and rheumatoid and psoriatic arthritis.

Based on my due diligence, before accepting the position with Coronado and my experience in this space, I am convinced that Coronado is at the forefront of addressing the mystery of autoimmune diseases and dramatically changing our concept on how to modulate and correct the inappropriate immune responses that characterize these conditions. This change in paradigm can transform the model of care of these patients from treatment with potentially harmful immunosuppressive drugs and biologics to the use of TSO a natural product which seeks to reestablish tolerance and the regulatory balance of the immune system.

Moving on to our products and development, during the second half of 2012 and the first quarter of 2013, both of Coronado’s clinical programs, TSO and CNDO-109 made significant progress. Five clinical trials were initiated. Four for TSO and one for CNDO-109 and the company signed a clinical trial agreement with the National Institutes of Health and manufacturing agreement with our partner, OvaMed, and a research collaboration agreement with the Freie Universität of Berlin.

Starting with TSO; as you recall, there were currently two company sponsored Phase 2 clinical trials underway evaluating TSO for the treatment of Crohn’s disease and TRUST-I, being conducted in the U.S. by Coronado and TRUST-II being conducted in Europe by our development partner, Dr. Falk Pharma.

In the TRUST-1 study, 220 Crohn’s disease patients are randomized to receive TSO 7500 Ova or a matching placebo every other week for 12 weeks. The primary endpoint of this study is the proportion of patients who achieved a response, which is defined by at least 100 point drop in the Crohn’s Disease Activity Index or CDAI. The TRUST-I trial is now enrolling patients at approximately 80 sites across the US. Enrollment is progressing as planned and we remain on target to announce topline results from this trial in the second half of 2013.

TRUST-II, the European study is also well underway. This study is a double blind placebo controlled dose ranging study comparing high, medium and low dose TSO to placebo. We were very encouraged in April, 2012, when an independent data monitoring committee for the study reported that there were no safety issues among the first 120 patients enrolled and based on a positive efficacy trend, recommended that the next analysis be performed after a total of only 240 patients enrolled, which based on the current projected enrolment rates should provide topline results to be reported in the second half of this year.

While Crohn’s disease is our lead indication for TSO and the TRUST-I study is our focus, several investigator initiative studies are exploring TSO’s potential and other indications. We recently announced the sort of investigators sponsored trials studying the effectiveness of TSO in three different autoimmune diseases.

Dr. Michael Poles and P'ng Loke at the New York University School of Medicine initiated an 18 patient trial in ulcerative colitis. Dr. Eric Hollander, at the Albert Einstein College of Medicine initiated a 10 patient trial in adults with autism. And Dr. Mark Lebwohl at the Icahn School of Medicine at Mount Sinai initiated an open-label multi-center 20 patient trial in Psoriasis. We also announced the finding of a clinical trial agreement with the National Institute of Allergy and Infectious Diseases or NIAID, which is one of the institutes of the National Institutes of Health to evaluate TSO for the treatment of ulcerative colitis in a 120 patient multi-center Phase 2 clinical trial that will be conducted by the NIAID funded autoimmunity centers of excellence. Dr. Stephen Hanauer, at the University of Chicago, is the principal investigator of the study, which is anticipated to enrol the first patient in the first half of 2013. In addition to these diseases, investigator sponsored studies are also underway or planned for multiple sclerosis, pediatric autism, Type 1 diabetes, psoriatic arthritis and rheumatoid arthritis.

To summarize; when the combined the investigator sponsored studies and our two large Phase 2 trials in Crohn’s disease, TSO will be studied in over 10 clinical trials across eight potential disease indications during 2013. We believe this speaks to the wide ranging interest from the medical community to explore the [high gene, high parenthesis] and examine TSO’s potential to regulate the immune system.

To that point, we recently announced the funding of sponsored research agreement and a joint ownership and inclusive license agreement with the Freie Universität of Berlin for the identification and evaluation of secretory proteins from Trichuris suis. The evaluation will be done in various preclinical in vitro and animal models to further describe the mechanism of action for TSO, and they also result in the identification of novel targets and immune modulatory agents as potential therapeutic candidates further the treatment of autoimmune diseases. Dr. Susanne Hartmann, Professor and Head of the Institute Of Immunology and Infection Immunology at the Freie Universität of Berlin is leading this effort.

In December we acquired the TSO manufacturing rights from OvaMed for North American, South America and Japan which are Coronado’s licensed territories. This acquisition is an integral piece of our strategy for TSO as it enables us to further control the development and commercialization of the product. The agreement is not only cost effective, but also reduces product risk by ultimately having two qualified suppliers. As part of this transaction, we also entered into a lease agreement to establish our own manufacturing facility in Woburn, Massachusetts. We plan to build up this facility in 2013 to be in a position to have Phase 3 clinical supplies manufactured in this US facility.

Moving to CNDO-109, we initiated a Phase 1, 2 trials in acute myeloid leukemia in late November. The study is a dose escalation of allogeneic natural killer or NK cells activated by CNDO-109 in patients in first complete remission from AML and who are deemed high risk for relapse.

This patient population is attractive to us due to the fact that over 70% of AML patients who achieve a first complete remission will relapse and thus remains a significant critical medical need. As a reminder, CNDO-109 has already been evaluated in a small Phase 1 investigator initiated trial. The study demonstrated that a number of patients experienced a longer complete remission after receiving CNDO-109 activated NK cells than their previous complete remission.

That summarizes our recent events. I will now turn the call over to Dr. Lucy Lu who will review our financials for the fourth quarter and year end 2012. Lucy?

Lucy Lu

Thank you, Harlan. We released our financial results for the fourth quarter of 2012 and the year ended December 31, 2012 in the press release this morning. Our net loss in the fourth quarter ended December 31, 2012 with $8.7 million compared to the net loss of $6.7 million in the fourth quarter of 2011.

The increase is primarily due to a charge for [each office] R&D expense of $1 million in connection with our acquisition of manufacturing rights to TSO from Ovamed for our territory and increased research and development expenses associated with our increased TSO clinical trial activity.

For the year ended December 31, 2012; Coronado reported a net loss of $27.6 million compared to a net loss of $36.4 million for 2011. R&D expenses were $17.5 million in 2012 versus $8.6 million in 2011. The increase is primarily due to our ongoing Phase 2 TRUST-I study in Crohn's disease.

G&A expenses were $8.7 million in 2012 versus $5.8 million in 2011. The increase is primarily due to increased infrastructure and personnel costs also in 2011 we had a $20.7 million in process R&D charge for our acquisition of TSO, whereas in 2012, we had only $1 million of in process R&D charge for the acquisition of TSO manufacturing rights.

At December 31, 2012; Coronado had $40.2 million of cash. During the first quarter of 2013, the company filled an aggregate of approximately 1.4 million shares of common stock under our after market issuance facility for net proceeds of approximately $10.5 million.

The ATM provides us an opportunity to sell registered shares into the open market from time-to-time under our S-3 shelf registration. We believe that our current cash position is sufficient to fund our projected operating requirements through the first quarter of 2014 based upon our current operating plans.

We expect that our burn rate will be between $8 million and $9 million for the quarter in 2013. I will now turn the call back to Dr. Weisman for closing remarks and Q&A session.

Harlan Weisman

Thank you, Lucy. Looking ahead in 2013, we expect to continue our progress in the clinic and we will have several opportunities to continue building Coronado’s presence in the medical and biotech communities. On April 09, 2013; we will be holding an Analyst Day in New York to provide an update on the hygiene hypothesis and TSO.

Leading scientists, key opinion leaders and physicians involved with the clinical development of TSO will make presentation on the drugs potential to treatment inflammatory bowel diseases such as Crohn's disease and ulcerative colitis as well as Autism, psoriasis and Type-1 diabetes.

We hope you will be able to join us. Please contact Dr. Lucy Lu for additional information. In closing, the anticipated results from Trust-1 and Trust-2 and possibly the results from two of the investigator sponsored studies in psoriasis and Autism will make the second half of 2013 a very exciting time for Coronado and its shareholders.

I look forward to meeting with many of you at various analyst, investors and scientific conferences throughout the year. I want to thank you for taking the time this morning to listen to our 2012 fourth quarter and year end call.

Operator, I would now like to open it up for questions.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from the line of Ian Somaiya with Piper Jaffray. Your line is open.

Ian Somaiya - Piper Jaffray

I had a few questions. Maybe if we can start off with a question for you, Harlan, I know you spoken about the level of diligence you’ve conducted on Coronado. I think you just help us to know what in the diligence really drove you to this decision to join the company and ultimately sort of spearheaded in its efforts?

Harlan Weisman

Good morning Ian and thanks for the question. There are several factors, one of them was really just understanding the science behind the hygiene hypothesis, the role of (inaudible) and specifically the accumulated in vitro pre-clinical animal and importantly human studies that really were coming together to show not only the scientific possibility of the hygiene hypothesis and the important royalty or so, but also beginning to accumulate the evidence that TSO will be an important part of the management operations with autoimmune diseases and really offering a change in perspective from the way we look at autoimmune diseases specifically but also many other diseases in which information plays a role.

And that is rather than looking at diseases which we treat with powerful drug and biologics to suppress immunity, it's restoring the health of people by restoring components that had always been there with us and which we involve with such as (inaudible) and other parasites.

So that was very powerful and then there was accumulated evidence and very importantly and always the case with any company when you are thinking about how it's going to go is the quality of the people. I knew some of the people already who are directly employed by Coronado and they have really some of the (inaudible) in my opinion but also the collective group of internationally recognized thought leaders KOLs, researchers who were knocking on the door of Coronado anxious to collaborative work with them, all of that together painted a picture which I thought based on my experience in doing due diligence in a lot of companies, painted a picture of a very unique opportunity and I really excited to know be a part of it.

Ian Somaiya - Piper Jaffray

Okay,

Harlan Weisman

You mentioned you have some other questions.

Ian Somaiya - Piper Jaffray

Yeah, I know I did but just to the follow-up on to that, if we think about the half a dozen or so clinical trails are ongoing and before you mentioned that you’ll get plenty of data before the end of the year, and how should we think about the potential from trail to the other, something it's obvious in the Crohn’s studies and to Crohn’s trails but just as you think about the Crohn’s trails data reading out potentially first, what implication do you think they have on the other indication which you are pursuing?

Harlan Weisman

First of all, as you indicated the Phase 2 trails will certainly validate TSO as an important therapeutic but in addition, it will be a very significant validation of the hygiene hypothesis and the important role of TSO, on the in autoimmune diseases and in my opinion it will not only be a significant derisking of TSO for inflammatory valve diseases but for all autoimmune diseases, we have really in my opinion extraordinary implications for the potential of TSO across the board.

Ian Somaiya - Piper Jaffray

Okay and just one last one, is there a path or is it possible for you to pursue breakthrough designation for this target and obviously we see this as a breakthrough opportunity sort of bear fruits in the next round of clinical trials, but is there a formal process that you can pursue with the FDA to get that designation.

Harlan Weisman

Yeah, we really believe there is that possibility and one of the things that is occupying the time of the management team in addition to making sure that we are executing against the clinical trials is really strategically focusing on which of the many opportunities we have offers and opportunity to accelerate to the marketplace, and so we are looking across the board at these indications and seeing whether its Crohn's disease and we will undoubtedly and I'm confident for TSO Crohn’s disease that maybe one of the other indications that may offer a quicker path following that accelerated breakthrough approval process that the FDA has recently announced and has implemented.

Operator

Our next question comes from the line of Joe Pantginis, Roth Capital Partners.

Joe Pantginis - Roth Capital Partners

A few questions as well, Harlan you talked about and thank you for sharing your thoughts about the reason for joining the company and the overall profile. A lot of times when CEO started the company they will undertake obviously levels of strategic review. At least at face value it looks like its pretty much status quo on all the studies and what's going on at Coronado. I was just wondering if you can share any views on what might have been tweaked or how you sort of decided to keep everything relatively status quo.

Harlan Weisman

Well as you mentioned I really viewed my first 90 days and I'm still in the middle of it. So, really learned as quickly as I could about the company, about the strategy, about all the programs that were underway, and importantly learned about all the people and get to know everyone even more than I had as a Board member.

I don't think that there's anything broken and therefore nothing needing fixing. But we are transitioning the company from a startup phase to a biotech company now that is about to complete Phase 2 in its first indication moving to Phase 3. We are about to undertake manufacturing and the ability to manufacture GMP quality certified product that could be used both for Phase 3 and commercialization and we have a number of other opportunities in front of us, and this increases the complexity of what we are doing and I would say my main focus and the focus of the management team is really to look at where the greatest opportunities are and to make sure that we focus our energy, focus our people, focus our money in those few things.

It’s a wonderful thing to have multiple opportunities, but it also presents a great challenge and you can't do it all at once. If you do everything at once, you are not doing any of them well. So I think that's going to be the main focus as saying, where are the greatest one, two or three things out of the many choices we have to go after.

Joe Pantginis - Roth Capital Partners

And then with regard to your about the financial resource that you have, its actually good segue for my next question. [IFPs] obviously are very low cost for the company, I guess I just wanted to ask about the ulcerative colitis study with the NIAID about how much of the cost of that study Coronado is putting.

Harlan Weisman

Really, our only significant cost in that study is the supply of TSO. Otherwise the cost are just are collaborative efforts in working with the [Travels] group and the NIH on things like study design and conduct of a study in any way that we can be helpful to ensure the success of the trial. But it really is just a drug supply issue and that’s something that is not a very substantial burden on the company.

Joe Pantginis - Roth Capital Partners

And then just two quick follow ups, I guess, I think it's very exciting, the initiatives you are starting with the Berlin group regarding mechanism of action. When do you think we might see those programs bearing some data fruit?

Harlan Weisman

Well, I think Professor [Hoffman] already has some work going underway and in science and research you just never know the answer to that, and I’d hate to hazard I guess. I would like to say as quickly as we can, we like to see this research bear fruit. But I am also humbled by the fact that science isn’t easy, research some of these doesn’t go smoothly and you discontinue the effort. So I really can’t give you any definitive answer there, but other than to say that we are optimistic about it and would hope that we would see something as soon as we could.

Joe Pantginis - Roth Capital Partners

Sure, sure. And then just lastly, I know this is a very broad based question but I am asking you based on your prior experiences before joining Coronado. So when you look at Crohn’s disease for example, how do you sort of view TSO fitting in the competitive landscape right now in Crohn’s?

Harlan Weisman

Well, what we've seen so far is that TSO seems to achieve the same efficacy in the same territory as the anti-TNF. The main distinguishing qualities of TSO are one, it's administered orally and easily, it's a table spoon of clear odourless, virtually tasteless like with every, it's look like water, every two weeks. So it's very easy to administer. No injections, no needles, so that’s one.

But number two, and I think very importantly is the safety profile that we have seen and which we expected was extraordinarily benign. We have not seen any toxicity of any significance with TSO, it does not suppress the immune system, it allows the immune system to be regulated itself to a more stable state, and therefore we believe achieving the high degree of efficacy of anti-TNF with an easy mode of administration and convenience and most importantly a terrific safety profile will really be differentiating factors that give competitive advantage to TSO.

Operator

Our next question comes from the line of Megan Dow with MLV & Company. Your line is open.

Megan McCloskey Dow - MLV & Co.

I got a couple of as well; you guys are just getting pummelled with questions today. You are ready? I have got a couple of questions starting up with a manufacturing, the agreement of bringing manufacturing and how is this obviously something why all the (inaudible) are positive. I was wondering if you could walk us through exactly what is the manufacturing process that Coronado is going to be setting up and can you talk a bit about the quality control that might be able to protect the natural products legally as well?

Harlan Weisman

Well in many ways the manufacturing of TSO is a pretty simple process, it’s a natural process. We harvest the eggs as they are excreted from the pigs and that’s done by a manufacturing partner that’s called parasite technologies, so ParaTech which is located in Denmark, and they filter clean, sterilized prepare what then becomes our active pharmaceutical ingredients or our unformulated [both] product which is deliver to the manufacturing partner today which is Ovamed, and Ovamed pretty much their process is to go through a fill and finish process including additional sterilization, anti viral elevation test which ensures there is no contamination and then going to a stone finish.

So its pretty straight forward in that way, but it is a biologic and it is under the stringent biologic GMP processes goes in US and then in Europe, and that requires a lot of measures related to quality that you mention and also to demonstration of a consistent process that repeatedly, consistently produces the same product in the vials every time.

Well, on paper that is straight forward and there is nothing really complex. From an engineering standpoint the execution of it is often challenging for a company. So we are putting a tremendous amount of effort in this, we are working very closely with our partners Ovamed, Parasite Technologies, Dr. Falk Pharma and we have also assembled leading experts in biologics manufacturing biologics quality control to consult with us to ensure that we meet all the standard of high quality GMP biologics manufacturing. The other important aspect for us and why our agreement and our collaboration with Ovamed and Parasite Technologies and Dr. Falk is so important is that what comes out of our plants and what comes out of the Ovamed plants have to be identical.

They have to be not only consistent but they have to be the same and we need to be able to certify our plant and by the European authorities as well as the FDA and they need to do the same thing at Ovamed and that requires a lot of coordination and collaboration and a lot of planning but we have all of that underway and I'm very optimistic that we will be able to do this smoothly and get to a well defined consistent manufacturing process as we proceed.

Megan McCloskey Dow - MLV & Co.

And so just so I understand you are going to continue using the Dutch Parasite Technology company to get the…

Harlan Weisman

Yeah, Megan that's right, it’s Danish, it’s in Denmark and it’s a brand new plant. It was a plant that just opened up. The second plant that just opened up was recently inspected and approved by the Danish government which is very stringent and is recognized by the European authority.

So we will continue to work with them. There is certainly the possibility that in the future Parasite Technologies would consider opening another plant that might be more geographically contiguous with ours but that's in the future.

Right now they have an extraordinarily rigorous process and there's no need to change that and there's no great limitation by in terms of the natural production of the product in the (inaudible) which are produced. They are quite capable of producing any amounts of commercial product that we will need.

Megan McCloskey Dow - MLV & Co.

Okay fantastic so that's actually kind of leads into my next question which is on the your intellectual property on the products since you mentioned the natural products and these pigs are potentially to be farmed anywhere I suppose, what kind of steps are you taking to ensure your intellectual property rights?

Harlan Weisman

So you are right. It is a natural product and the composition of matter because its natural you don't speak of that as you would with a synthetic product. So the real intellectual property surrounds the use of the product for the indications for autoimmunity and there are very broad patents originally issued to the University of Iowa licensed to Ovamed and then sublicensed to us that protect the products usage in autoimmune diseases but they are very broad patents in the sense that they cover not only TSO but the use of any hermetic organism in these autoimmune diseases in addition to those additional University of Iowa patents. We continue to file patents as we gain further scientific understanding of the product and its intended uses.

Operator

(Operator Instructions) Our next question comes from the line of Christopher Marai with Wedbush Securities. Your line is open.

Christopher Marai - Wedbush Securities

My first question is regarding enrollment of TRUST-1 and TRUST-2. I was wondering how that’s progressing and if you had any data points around that? And then second, TRUST-2, inclusion criteria doesn’t include the CDAI score but it’s based entirely upon endoscopy, yet the endpoint is primarily based upon the CDAI or so, I was wondering how important those two observations are and if you had any data around that? And then lastly, in terms of ramping up the US manufacturing, what’s the cost around getting that set up? Thanks.

Harlan Weisman

Thanks, Chris and good morning. In terms of the enrollment in the two trials, TRUST-1 and TRUST-2, they are both enrolling briskly and in fact, earlier, just even two months ago, we were just starting to see the ramp up of the trial.

We were uncertain whether that was a [trenzy] and phenomena and whether we continue and everything that we are seeing indicates that the trials are enrolling at a really nice rate, at a rate that at least meeting expectations if not exceeding expectations and we're quite confident that enrollment will complete with plenty of time to finish the follow up with the patients, obtain the data, lock the database, analyze it and present a top line results in the second half of this year.

In terms of exactly where we are that’s something that we're not discussing. So I am going to be a little clear there, but only to state that we are overwhelmingly positive about where we are and confident in our ability to complete the trials, to have those top-line results in the second half. I think you said, TRUST-II, but TRUST-I is the trial of the US trial in which the CDAI has been used both as the prior for the determination of the primary end point, which is a clinical response and that’s a CDAI drop of at least a 100 points and also for the major secondary end point of remission, which is a drop in CDAI below 150.

The reason for these of the CDAI that that is not only the traditional, but it is the standard that has been used for the approval of all products that are been approved for Crohn’s disease beginning with Remicade, I guess now 15 years ago. And as you mentioned, we are using endoscopy as an entry criteria and the reason for that is that in all trials there is an attempt to assess, whether the patient is in an active inflammatory state.

Traditionally that’s been used by measuring non-specific inflammatory markers such C-reactive protein or CRP. The problem with CRP is although it’s a sensitive marker of inflammation it's not a specific marker of information and therefore there can be other causes. The reason we are using endoscopic findings is that we are verifying that there is in the intestinal track active Crohn’s disease, active inflammatory process, consistent with Crohn’s disease going on. So that is ensuring in a way that to the best of my knowledge has not been done before in drug approval trails, that the patients were enrolling actually have Crohn’s disease that is highly active.

Now why not just CDAI? And the reason CDAI is a great measurement of how our patients doing with their Crohn’s disease and often the CDAI growth is a reflection of the active Crohn’s disease in the inflammatory process of the Crohn’s disease. But it could also be do other things, it measures non-specific symptoms such as abdominal pain, diarrhea and there can be other causes of that. In Crohn’s patients for example severe abdominal pain and distress can be caused by a narrowing in the intestinal track due to scarring, which are called [sunosis] which are due to Crohn’s disease but are non-inflammatory.

So we wanted to really make sure that we were addressing inflammatory Crohn’s disease and that’s the reason for using it. In terms of the correlation, they don't correlate well always and because of this fact that there are other things, other than active Crohn’s disease, I can give you an alleviated CDAI.

Christopher Marai - Wedbush Securities

And then in terms of just the US manufacturing question and ramping that up. I was wondering if you could give us any color on the cost of that potentially.

Harlan Weisman

Yeah, because the capital costs which are by and large the cost of manufacturing other than any headcount additions we need which are also non-substantial is not a lot of money. It’s mostly time and effort, and we are really talking about low single digit millions, not tens of millions of dollars of investment to get us to a point where we can have a facility that is up and running and providing us with GMP high quality material for a Phase 3 trial.

Operator

At this time I'm showing no other questions, so I would like to turn it back to Dr. Harlan Weisman for any closing statements.

Harlan Weisman

Just in closing, I wanted to thank everyone on the call for joining us this morning, and also for the questions that were asked of us and I look forward to meeting with all of you in the future at beginning perhaps with our Analyst Day coming up in April, as well as other opportunities at investor and scientific conferences throughout the year. Good morning and thank you very much. Bye-bye.

Operator

Ladies and gentlemen this does concludes your conference. You all may disconnect and have a good day.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!