FBIO - NASDAQ

Lucy Lu - CFO Harlan Weisman - Chairman & CEO

Ian Somaiya - Piper Jaffray Andrew Goldsmith - Canaccord Genuity Steve Byrne - Bank of America Merrill Lynch Boris Peaker - Oppenheimer

Good day ladies and gentlemen and welcome to the Coronado Biosciences Second Quarter 2013 Results Conference Call. (Operator Instructions). I would now like to introduce your host for today’s conference call Dr. Lucy Lu, Chief Financial Officer. You may begin.

Great, thank you. Good morning, everybody. This is Lucy Lu, CFO for Coronado Biosciences. Thank you and welcome to our second quarter 2013 financial results conference call. Before we begin I’d like just 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 initiations, enrollment and results; potential future clinical results; the therapeutic and commercial potential of our product candidates and their regulatory pathways; intellectual properties’ position; our manufacturing, supply, and other collaborative arrangements and the sufficient fee 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 Annual Report on Form 10(k) and our Form 10(1) for the quarter ended March 31 and June 30, 2013 and in our other filings with SEC. With that I’d like to turn the call over to Dr. Harlan Weisman, Chairman and CEO of Coronado who will begin the presentation, after which I will provide you with a summary of the financial results for the company. Harlan?

Thank you Lucy and thank you all for joining this morning for Coronado Biosciences earnings call to discuss the second quarter of 2013. With me on the call today in addition to Dr. Lucy Lu is Noah Beerman, our Chief Operating Officer; Dr. Karin Hehenberger, our Executive Vice President of Scientific Affairs, Dr. George Avgerinos, Senior Vice President, Biologics Operations and Dale Ritter, our Chief Accounting Officer. On today’s I call focus primarily on TSO providing an update on the TRUST-I and TRUST-II clinical trials, the important addition to the management team as well as our progress on the manufacturing front. I’ll begin with TRUST-I Coronado’s Phase II clinical trial evaluating TSO in Crohn’s disease in the United States. We recently announced on July 1st, the completion of enrollment for this study. The trial enrolled a total of 250 patients surpassing the target enrollment of 220 which was done to accommodate individuals, stone (ph) the screening process at the time the trial’s target enrollment was achieved. We anticipate announcing results from the TRUST-I clinical trial in the fourth quarter of this year. The primary endpoint for the study is induction of response of 12 weeks with induction of remission being a key secondary endpoint. Full details on the clinical trial can be found on clinicaltrials.gov. We believe the strong interest to participate in the TRUST-I file speaks greatly to physician’s interest in TSO and the hygiene hypothesis and patient's desire for a safer, more effective treatment option than what is currently available today. I will now spend a few minutes on TRUST-II, our partners Dr. Falk Pharma’s Phase II trial evaluating TSO in Crohn’s disease being conducted in Europe. As you may recall this trial has been adaptive design that specifies that interim analysis be conducted by an independent data. Dispersed interim analysis took place in April, 2012 on the first 120 patients. The independent committee noted there were no safety concerns and absorbed a positive efficacy trend. Additionally based on recommendations made by the independent committee Dr. Falk Pharma increased the sample size from 212 to 240 patients and will conduct a subsequent interim analysis at 240 patients. This trial continues to enroll patients and we believe is on track to report results from the second interim analysis in the fourth quarter of this year. The primary end point for this study is induction of remission at week 12 with induction of response at 12 weeks is a key secondary endpoint. The first interim analysis from Falk study was beneficial to Coronado in a few ways. Based on the recommendations made by the Independent Data Monitoring Committee we were able to selected the doses and sample size for the TRUST-I trial that we believe will optimize the probability of absorbing the treatment effect. Also, the interim analysis gave us additional evidence of efficacy and safety in a company sponsored clinical trial, especially validating the earlier conducted investigator initiated studies. In addition to TRUST-I and TRUST-II our clinical trial evaluating TSO in Crohn’s disease we have additional investigators sponsored trials underway. The investigator sponsored trials in autism and psoriasis both have the potential to report data either at the end of this year or in the first quarter of 2013. We also expect that additional investigator sponsored trials will be initiated later this year in ulcerative colitis, Type 1 diabetes, autism psoriatic arthritis and rheumatoid arthritis. We look forward to exploring the potential use of TSO in these indications. Turning now to our CNDO-109 program, we’re currently enrolling patients in a Phase I/II trial in the acute myeloid leukemia. This study is a dose escalation trial of allogeneic natural killer or NK cells activated by CNDO-109 in patients and first complete remission from AML as were deemed high risk for relapse. We have also announced today that Dr. Karin Hehenberger has transitioned to become our Executive Vice President of Scientific Affairs, and this newly created role Karin is leading the company’s strategic efforts in developing novel new indications for the products through internal development and external scientific collaboration and serves as the company’s spokesperson for scientific communications through external groups, including key opinion leaders, scientific meetings, the media and the investment community. Based on our extensive background in diabetes research and business evaluation she is also the lead person for our diabetes development effort. She continues to serve on our Executive Committee and reports to me. After Dr. Bobby Sandage’s departure I have taken on the role as Interim Head of R&D and will serve in that function until we identify an appropriate candidate for the position. Also this past quarter in June we appointed George Avgerinos as Senior Vice President, Biologic Operation to lead Coronado’s global manufacturing and supply chain efforts for both TSO and CNDO-109. Most recently, George was at AbbVie, formerly Abbott Laboratories where he was Vice President, Humira Manufacturing Scientist and external partnerships. In his 23 year career at AbbVie, George had responsibility for many aspects of biologics development and operations including the launch and manufacturer of Humira. George efforts on Humira have been recognized with numerous awards, including the prestigious Abbott's Chairman's award in 2011. I believe George’s extensive experience in biologics will significantly support our efforts in moving TSO and CNDO-109 forward including the development of the company’s manufacturing facility in Woburn, Massachusetts. Our partners Parasite Technologies and Ovamed are currently responsible for production of TSO used for clinical trial supply. The respective national regulatory authorities in Denmark and Germany have inspected their facilities. Both the organizations are implementing enhancements in the facilities and processes to meet production and quality needs for late stage clinical trials and potential future launch. Coronado has finalized the design and is in the process of bid review for the build out of our facility in Woburn, Massachusetts for manufacturing development, late stage material supply and potential launch. You’re preparing a request for a facility review meeting with the FDA and we anticipate completing construction in the first half of next year and starting production thereafter. With that I will now turn the call over to Dr. Lucy Lu who will review our financials for the second quarter of 2013. Lucy?

Thank you Harlan. We will release our financial results for our second quarter in a press release this morning. Our net loss in the second quarter ended June 30, 2013 was $10.7 million compared to a net loss of $6.5 million in the second quarter of 2012. R&D expenses was $7.8 million in the second quarter of 2013 versus $4.5 million in the second quarter of 2012. These quarter-over-quarter increases are primarily due to increased expenses associated with our increased TSO development activity related to our ongoing Phase II TRUST-I study in Crohn’s Disease. G&A expenses were $2.5 million in the second quarter of 2013 versus $1.9 million in the second quarter of 2012. The increase is primarily due to increased infrastructure and personnel costs. At March 30, 2013, Coronado had $67.9 million of cash. In the six months ended June 30, 2013 we sold 4.9 million shares of common stock and received net proceeds of 42.8 million under our ATM facilities. In June 30, we issued an additional 2.2 million shares for net proceeds of approximately $18.4 million under our ATM facility. To-date Coronado has built approximately 7.1 million shares on an ATM facility for net proceeds of approximately $61.2 million. The ATM provides us the opportunity to sell registered shares into the open market from time to time under our shelf registration. We believe that we’re in a good position with respect to cash resources and we expect our current cash to be sufficient to fund our operation for at least the next 12 months based on our current business plan. I will now turn the call back to Dr. Weisman for closing remarks and Q&A session.

Thank you, Lucy. The remainder of 2013 we believe will be a very exciting time for Coronado, it's shareholders the medical community and patients suffering from Crohn’s disease as data from TRUST-I and TRUST-II clinical trials are expected to be reported. We look forward to sharing the top-line results of these studies with you as soon as they become available and further exploring TSO’s potential benefit in the treatment of our autoimmune diseases. With that I would now like to open up the call for questions. Operator?

Our first question comes from Ian Somaiya with Piper Jaffray.

Look forward to the data on the fourth quarter. The first question I had was just related to the TRUST-I trial. I’m sure you can appreciate the historic variability and the placebo responses that are seen in Crohn’s trial. I was just hoping if you can spend maybe just a minute or two the steps you’ve taken to maybe mitigate that variability and it's potential impact on the trial outcome.

You’re right there has been a range of placebo event rates in a variety of clinical trials in Crohn’s disease patients anywhere from around 25% to a well over 40% response rate is at 12 weeks. However in our clinical trial independent of whatever the placebo response rate a trial will detect at least a 15% difference incremental difference between the placebo response rate and the TSO treated response rate whether that placebo rate is 25% or whether it's 50% it is that 15% incremental improvement that’s important for a statistically significant result and therefore we’re confident that the design of the trial allows us to detect both a medically significant as well as statistically significant results.

Is there a trial that you would maybe have us benchmarked? Recently conducted study that that would be serve as a good proxy for how the patients will behave in your trial?

Well during a variety of recent ones including the ones that lead to the Symphony approval in Crohn’s disease as well you know Centrix (ph) trial what’s in that trial was a placebo event rate of about 40% but we would expect placebo event rates in that 25 to 40 range but even let’s say that for uncertain reasons the placebo of that rate was even higher again the trial will be positive with an absolute incremental difference of 15%. So it really is placebo event independent.

That’s great. You know last question was just on the enrollment, I guess you’re over enrollment now. Can you just share with the impact that has had on the specifics of the trial? The powering of the trial?

Sorry, what of the trial?

The specifics of the powering of the study?

You know I haven't really looked at the difference between having 250 versus the original number but it clearly improves the power of the trial. By the way the numbers I have given you are numbers based on an actually absorbed difference. The trial was powered for absorbing a 20% difference at it's original number of 220 but that meant that it could detect differences as low as 15%, with 250 patients that power drops below 20% and I’m not really sure how much lower and therefore the lower limit of detection would drop below 15%, again I’m not exactly sure but if anything I’m giving you conservative numbers when I tell you we can detect at least a 15% difference.

Our next question comes from Salveen Richter with Canaccord.

Good morning this is Andrew Goldsmith on line for Salveen. Thanks for taking the question. I just had a quick question about the timing and I think it's a bit of an update from I think the second half for the first one. So I’m just curious anything changed or is this just kind of (inaudible) something when it's going to read out and then similarly if you’ve a sense of we’re going to see TRUST-I or TRUST-II first? Thanks so much.

It is a refinement on our previous estimates and it's a refinement based on the fact that we completed enrollment in July at the beginning of July and that allowed us to be able to say that we would certainly have the results in the fourth quarter of this year. We anticipate that the TRUST-I results will probably come ahead of the interim analysis from the TRUST-II study and that’s based on our completing enrollment in early July. Again our partners at Falk Pharma are confident that they will be able to provide the results in the fourth quarter of this year.

Our next question comes from Steve Byrne with Bank of America.

I was wondering if you were collecting any data in TRUST-I on biomarkers, the systemic information?

The biomarker of information that we’re collecting in that trial is c-reactive protein. We’re also collecting it's really at the option of patients, a stool marker which is Calprotectin but we would expect CRP to be the major inflammatory marker that we’re using. Probably the best inflammatory marker that we’re using at the beginning to screen the patients though is colonoscopy in which we’re verifying that all enrolled patients have active inflammation as the cause of their symptoms active Crohn’s disease.

And out of these roughly 500 patients that are in the TRUST-I and II studies are you aware of other inflammation or allergy related core morbidities and will you’ve data on any of that?

I’m currently not aware of core morbidities and other autoimmune diseases but we’re collecting past medical history, information as well as events that occur during the trial.

And then Lucy a quick one for you, what’s the current share count or at least what was it at the end of the quarter?

Sure the current share count is $31.9 million.

Our next question comes from Boris Peaker with Oppenheimer.

I just had a question on safety just on the TRUST-I study did you receive any kind of regular updates on safety and if you do anything you can comment regarding that?

I will give you the following comments as it relates to safety, one is that the trial is monitored in an ongoing leg (ph) by an independent medical monitor who is not part of who are not owned, independently reviews any submission of safety reports that would occur in the clinical trial that’s number one and number two, the trial specifies that an independent data monitoring committee would periodically review the course of the trial for safety and they have the meeting along the course of the trial and neither the independent safety medical monitor, the monitor safety for the trial nor the independent data monitoring committee have indicated to us any issues related to safety or tolerability in the trial.

Okay and in terms of Dr. Falk and the TRUST-II I understand that they have a similar committee and if you can just confirm that and also when they do their blinded (ph) analysis and allow the study to continue forward, do you get any kind of update to at least blind basis what the findings were and for your ability to maybe compare to yours and do you not get the kind of information.

So there is an independent data monitoring committee in that trial as well, that is the committee that reviewed the unblinded results for the interim analysis. They did report to the Dr. Falk in turn shared with us the observations and recommendations of that committee after the first interim analysis which I summarized mainly that there was a trend a positive trend towards efficacy and that there were no safety or tolerability issues among the four treatment groups which were placebo, a 250 egg per dose group, a 2500 egg per dose group and a 7500 egg per dose group so they were testing four groups and there were no differences among those groups in terms of safety, they also liked us having independent safety monitor, medical monitor who reviews any reports from that trial. In terms of the interim analysis that’s upcoming we anticipate that the TRUST-I trial having increased it's sample size which was another recommendation of that committee at the first interim analysis, will be able to detect a significant difference in their primary endpoint given the fact that there was a non-significant trends towards efficacy and they about doubled the number of patients since then in the trial which would indicate that you could move a non-significantly trend to a significant result in that endpoint. If that were to occur what would likely happen is the committee would report to doctor Falk Pharma as a result of their interim analysis that statistical significance that have been met and Dr. Falk and certainly there was, been in that group would likely make a decision to stop that trial at that point. We would have the results of the interim analysis at that point but because the trial continues to enroll patient beyond the designated number but final analysis if it were to stop later this year because of the interim would likely occur in sometime in the first quarter because they would have to get all the new data of the patients that have been enrolled from the time of the second in germ analysis to the time of stopping the trial. Hopefully I didn’t confuse you too much but that was, are the details of what Dr. Falk and we would possibly know at the time of their second interim.

That’s very helpful. I’m just curious you mentioned that in the prior analysis it wasn’t routine statistical significance and that’s why they increased the patient size. Do you know how close statistically were they to that threshold?

I think we surmise but we do not know, the committee did not give us any specific numbers or any specific p-value. A non-significant positive trend would usually be interpreted as a p-value between 0.05 and 0.1 if you’re in that range and you take and you’ve that with a 120 patients if you double the sample size you should end with the same trend, those trends should result in a significant p-value but that’s the best I can do on this and again that’s just position of our part. They were not explicit with us or Dr. Falk.

Our next question comes from Chris Marai – Wedbush.

Quick update, you had discussed powering the study and that what power sort of see a 15% incremental improvement over placebo. Is that 15% medically significant improvement in patients and what is generally considered the medically significant benefit there if you could remind us?

Yeah 15% would be considered a very medically significant result. In recent trials of, in Crohn’s disease and in ulcerative colitis or related inflammatory bowel disease some of the pivotal trials have shown a results in as low and as 10% of a difference and these arein pivotal trials, these are much larger trials obviously. And those have led to regulatory approval of those products. So and in informal discussions I had with thought leaders the view is that a difference of 10% or greater would be considered a medically meaningful result from a clinical trial and that’s because of the great variety and diversity of patients and centers in the study and that an actual practice the belief of practitioners is that if they could take patients that are otherwise not responding to available therapy and have that type of incremental difference above standard therapy but that would be a valuable part of their treatment are momentary (ph).

Also just a quick update on how many patients are enrolling in your 24 week extension study there, how is that going?

We haven't really talked about the exact number but what I can tell you is the vast majority of patients who have been offered open label experience have opted to enter the open label phase of the trial which means that two things I think and the patients already been treated with TSO in the trial, we will have 24 weeks outcomes of treatment in those patients which will be valuable in demonstrating both the safety of TSO for declaration and also the maintenance of efficacy in those patients and in the placebo patients who opted fully open label portion we have the opportunity of an internal validation of the original 12 week study by looking at the response rates of those placebo patients we then given the option to be given TSO and look at their response rates in the open label portion. So we’re very much looking forward to the results of that part of the study as well.

Great. Are you expecting to announce that data? Obviously after the TRUST-I and TRUST-II read out but are you guys anticipating on providing an update at the 24 week time point?

Sure. We have meaningful information on that endpoint. We will give again top-line results saving the details for an appropriate medical meeting that will be coming up.

And then one final one if I may, you were talking about first half of 2014 to get production setup, how does that impact setting up a Phase III pivotal trial and what will the timing of the initiation of such a trial look like and have you thought about the design or started discussing design elements with the FDA? Thanks.

First of all in the terms of the Phase III trial of course we need to wait for the results of TRUST-I and TRUST-II to get into the specifics but yes we have been thinking a lot about the design of the Phase III study both within Coronado with Coronado with Dr. Falk, we have a co-development agreement with and we would anticipate a Phase III program that would lead to a registration strategy acceptable both in the United States and in Europe for Crohn’s disease. In terms of discussions with the FDA what we would anticipate is after we have the results of the TRUST-I and TRUST-II trials and we have had an opportunity to fully analyze them and light it up for submission to the FDA that we would have a after Phase II meeting with the FDA to discuss our Phase III program and receive their by-end and our design would be acceptable for obtaining approval for TSO in Crohn’s disease. And sort of the manufacturing George has certainly committed that in no way we will manufacturing be weight limiting to our ability to supply their clinical trials and his plan for that and for bringing up production and he works closely with our partners Ovamed and Parasite Technologies is that we will have adequate material for Phase III, to initiate Phase III and complete Phase II without any trials supply limitations.

Our next question comes from (inaudible).

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And yes I think as we continue to proceed with receiving the TRUST trial results as well as moving into new indications and expanding our manufacturing capabilities, it will be necessary for us to build a solid core group of both executives and staff to fill in the capabilities that we will need that we don’t currently possess. Our philosophy in this regard is to bring in star talent as you’ve noted, to fill those capability gaps that we have that we will need to fill for the ongoing success. But in situations where we’re talking about on activities that can be performed through a contracting we will do that. So you will see us expand head count somewhat to bring in the core expertise that we need to both manage internally as well as manage contract workforce within clinical trials and in manufacturing as well in preclinical studies, but we want to have the agility to adjust and move quickly based on it's circumstances and we feel that rather than building out and being burdened by a lot of capital expense on bricks and mortar as well a large workforce that is better to continue our strategy of utilizing contract research organizations and other contractors that can expand the number on arms and legs if you will to carry out the operations that we need on our strategy. So most of the head count will be adding strategic capabilities to us and we’re continuing to examine those needs and assess potential candidates to bring into the company.

Just a follow-up on that I mean certainly in terms of R&D you bring a lot of (inaudible) task but how important right now is that need vis-a-vis some other additions you might be considering?

Well I’ve a full-time job as CEO so it is important to make sure that we have high quality top-notch executive as well as staff in the R&D arena. We have a base which is absolutely terrific, when I came into the company I was really impressed with the quality of the people residing in Coronado but also recognize this we grew that we needed to supplement the individuals that we already had. R&D is a critical area and bringing in the leadership to oversee the variety of new activities that we will be taking on to dive into new indications as well as Phase III is highly important and really a focus of my attention and I think over the next few months we will be evaluating specifically what type of editions we should be looking in.

All right. Just a question on TSO and Crohn’s disease, so you seem at least in the past in terms of your comments around advancing TSO and Crohn’s disease. You seem to project a certain amount of confidence or at least a sense that things would be able to move forward into Phase III, so just ahead of the announcement of TRUST-I and TRUST-II, can you just give us your sense right now your current estimate of your level of confidence that you will be able to move into Phase III?

I have not wavered in any way in my confidence about TSO and the efficacy in Crohn’s disease as well with other autoimmune diseases that I’ve expressed previously and I remain steadfast in my belief that TRUST-I and TRUST-II trials are extremely well designed Phase II trials that have been that have the ability to demonstrate the safety and efficacy. So nothing has really changed certainly as the moment comes no matter how competent you are, you will always think about that it and second-guess things but I can tell you there is nothing that has changed my opinion in any way or changed my mind about what we expect to see as results from these trials.

Great and then just one last question if I may just regarding the other trials for TSO and the other indication that might begin in the second half of 2013. Do you have a sense of what we might be able to get us a readout of the data in those trials in 2014?

Well I mentioned two of the studies that are underway, one in psoriasis and one in autism. They are both small trials designed as signal detection trials and safety tolerability studies in terms of dosing. When we get the results of this entirely is dependent on enrollment, thus far enrollment has been very good in those studies and again there is that duration of treatment and follow-up these next series (ph) trial that implements on top of enrollment. It is still possible that we could get some top-line results in those two trials this year, but I certainly likely the likely possibility is that we will see results towards the beginning and next year in the first quarter. In terms of other studies that are underway again same caveats in terms of dependency on enrollment. The multiple sclerosis trial being conducted at the University of Wisconsin is still underway, all the patients have been enrolled but they are still in treatment and there is part of long follow-up period but again that should be something towards the early part of 2014 that we might have to see results in. The other trials are such as ulcerative colitis that we will be getting underway in a couple of months, within a couple of months in the fall. That one is a large trial and I would anticipate we will extend beyond 2014 for results. We also will have some trials in Type 1 diabetes that will be getting underway but again those are probably long-duration trials and we’re unlikely to have results in 2014. And we also have an autism study that we will be getting underway in the early fall and in all likelihood again it's a long-term trial. So that’s probably the earliest possible results next results are really psoriasis and autism.

(Operator Instructions). Our next question comes from (inaudible).

Assuming that the ongoing Crohn’s trials meet with the success that you expect and without trying to define what a Phase III might look like, what would you think would be the optimum timeline for initiating a Phase III trial and completing it successfully? I know it's kind of a vague question, but perhaps you can help me with that.

It's entirely dependent on a couple factors, what we need to do as I mentioned earlier is put together a package for a meeting with the FDA and Dr. Falk with the EMA to review the results of Phase II, and to provide them with our proposed Phase III clinical trial in Crohn’s and that will take just the that procedure alone it will take several months to go through. We will also begin the process of identifying study sites, investigator that can participate, again like Phase II this will be a multicenter trial across geographies and all of that going through the approval process at each of the centers getting their institutional review board approvals, contract approvals and so forth is a length event. So we certainly plan to start the trial in 2014 but at this point it's hard to have further precision than that.

Our next question comes from Boris Peaker with Oppenheimer.

I just had a quick question, in your opening remarks you’ve mentioned Ovamed and some other company that I think you have as a contract manufacturer, I didn’t catch the name of that other company. Can you just repeat it?

The other company is Parasite Technologies, it's located in Denmark and it's also known as Para-Tech, full name is Parasite Technologies.

I’m not showing any further questions at this time. I would like to turn the conference back over to our host for closing remarks.

I'd like to thank all the participants who both listened to our formal presentations and asked us questions. We look forward to being able to share the top-line results of our Phase II trials TRUST-I and TRUST-II later on this year and really appreciate the interest that you’ve shown in Coronado Biosciences. Thank you and good morning.