FBIO - NASDAQ

Harlan Weisman – Chief Executive Officer Lucy Lu – Executive Vice President & Chief Financial Officer Noah Beerman – Executive Vice President & Chief Operating Officer Karin Hehenberger – Executive Vice President & Chief Medical Officer Dale Ritter – Senior Vice President, Finance & Chief Accounting Officer

Matthew – Piper Jaffray Salveen Richter – Canaccord Genuity [Fasin Ahmed] – Bank of America Megan Dow – MLV & Co. Christopher Marai – Wedbush Securities Jay Silverman – BioInvest

Good day, ladies and gentlemen, and welcome to the Coronado Biosciences Q1 2013 Results Conference Call. (Operator instructions.) As a reminder, today’s conference is being recorded. 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 Q1 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, their enrollment and results; potential future clinical trials; the therapeutic and commercial potential of our product candidates and their regulatory pathways; intellectual properties’ position; our manufacturing, supply, and other collaborative agreements; 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 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’d like to turn the call over to Dr. Harlan Weisman, Chairman and CEO of Coronado Biosciences 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 us this morning for Coronado Bioscience’s earnings call to discuss Q1 2013. With me on the call today, in addition to Dr. Lucy Lu is Noah Beerman, our Chief Operating Officer; Dr. Karin Hehenberger, our Chief Medical Officer; and Dale Ritter, our Chief Accounting Officer. During Q1 2013 Coronado remained focused on driving our clinical programs forward. On April 9th we held an analyst and investor event in New York City with leading clinicians in the field of inflammatory bowel disease, autism, psoriasis, and Type I Diabetes who reviewed TSO’s potential to treat diseases marked by immune disregulation. On today’s call I’d like to highlight some of the key takeaways from the analyst and investor event and provide a quick update on our clinical trials underway for TSO and CNDO-109. Dr. Lucy Lu will then review our Q1 2013 financials and the recent sale of common stock through our at-the-market sales facilities. Following our prepared remarks we’ll be happy to address any questions you have. As many of you know, the interest from the medical community to study TSO in a number of autoimmune diseases beyond the company’s sponsored trials in Crohn’s Disease has been really impressive. We’ve received and continue to receive requests and proposals for clinical trials from leading clinicians and researchers around the world. We take these requests very seriously and review each of them in detail. In many cases, the requests come with funding already identified from leading research organizations, significantly extending the number of new indications we can explore outside of inflammatory bowel disease – indications that were presented by leading experts at our recent Analyst’s Day, including psoriasis, autism, Type I Diabetes as well as multiple sclerosis. After obtaining the results of these studies we’ll consider pursuing larger, company-sponsored trials that could support regulatory approval. To date, five investigator-sponsored trials are underway and additional studies are planned to start in the second half of 2013 across seven different indications. In order to provide additional clarity on some of the indications being studied, we held an investor event on April 9th with a panel of TSO investigators who discussed the rationale for TSO in their field of expertise. Throughout the event, a few common themes were addressed by all of the physicians, which I’d like to highlight. First, for the indications reviewed there’s a large medical need. In the case of Type I Diabetes and autism there are few options to choose from. For inflammatory bowel disease and psoriasis there are a number of approved immunosuppressive therapies available but they don’t work for all patients, they can lose their effectiveness over time, and they’ve been associated with serious, sometimes fatal adverse events. To that point, the second theme relates to safety. For the indications being studied there is a need for safer agents to treat patients. To date, TSO has demonstrated a good safety profile. This has been one of the driving factors that has led physicians and researchers to get involved with the product. The third theme relates to the hygiene hypothesis. The hygiene hypothesis proposes that autoimmune diseases are increasing in prevalence in developed countries because well-intended efforts to improve hygiene have adversely disturbed the regulation of immune responses, resulting in inappropriate immune attacks on the body’s own tissues. Specifically, our bodies can be thought of as ecosystems that can be damaged by a reduction in the number and variety of organisms including bacteria and parasites that populate the intestinal tract, disrupting the mutually beneficial relationship between the host and these organisms. This environmental disturbance has resulted in the loss of the immune regulatory processes that normally prevent inappropriate inflammatory responses and the consequence is the rise of autoimmune diseases and immunologic disorders. We believe that TSO restores the immune regulation that was lost when the (inaudible) were eliminated from the human intestinal environment. To the best of my knowledge, TSO is one of the few products being evaluated under an FDA-regulated process that addresses the disturbance of the intestinal ecosystem, which is a common thread among immune disregulated diseases. It is this concept coupled with TSO’s unique mechanism of action that leads us to believe that it has the potential to show a treatment effect across a number of autoimmune diseases. In addition to these common themes, the panelists also provided details on the clinical trials underway, evaluating TSO in inflammatory bowel disease, Type 1 Diabetes, autism, and psoriasis. If you were unable to attend the event I encourage you to listen to the archived webcast which can be found on the “News and Media” section of our website. Moving to an update on our clinical trials, as you’ll recall there are currently two company-sponsored Phase II clinical trials underway evaluating TSO for the treatment of Crohn’s Disease: TRUST-I being conducted in the US by Coronado, and TRUST-II being conducted in Europe by our development partner Dr. Falk Pharma. The TRUST-I trial continues to enroll patients across the US. Enrollment is progressing as planned and we remain on target to announce top line results from this trial in the second half of 2013. TRUST-II also continues to enroll patients and is on track to also report results in the second half of this year. Additional investigator-sponsored trials in ulcerative colitis, autism, psoriasis, and multiple sclerosis are all underway. We potentially will have data in autism and psoriasis around the end of this year. For CNDO-109 a Phase I/II trial in acute myeloid leukemia has initiated. This study is a dose escalation trial of allogeneic natural killer or (NK) cells activated by CNDO-109 in patients in first complete remission from AML who are deemed high risk for relapse. In addition we announced yesterday that Dr. Thomas Shaible has joined the company as Project Leader for Inflammatory Bowel Disease or IBD. We’re excited that Dr. Shaible will lead Coronado’s R&D efforts in advancing TSO in IBD. I’ve known Thom for over 20 years and believe that his expertise in IBD and other autoimmune diseases will be greatly beneficial to Coronado as we progress TSO forward. Dr. Shaible led the teams that developed and gained approval for the use of Remicade for treating Crohn’s Disease in 1998 and rheumatoid arthritis in 1999 for which he received the Johnson Medal, the highest award for research innovation at Johnson & Johnson. In addition, Dr. Shaibel’s group designed and conducted SONIC trial in Crohn’s Disease, a major clinical trial published in The New England Journal of Medicine, demonstrating the superiority of Remicade versus a conventional immunomodulator – azathioprine – in reducing signs and symptoms of disease. I’ll now turn the call over to Dr. Lucy Lu who will review our financials for Q1 2013. Lucy?

Thank you, Harlan. We released our financial results for Q1 2013 in a press release this morning. Our net loss in Q1 ended March 31, 2013, was $8.9 million compared to the net loss of $6.6 million in Q1 2012. R&D expenses were $6.0 million in Q1 2013 versus $4.6 million in Q1 2012. The 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 Q1 2013 versus $2.0 million in Q1 2012. The increase is primarily due to increased infrastructure and personnel costs. At March 31, 2013, Coronado had $44.1 million of cash. In 2013 through May 7th we have sold approximately 3.4 million shares of common stock under our at-the-market sales facilities, or ATM, for net proceeds of approximately $29.9 million. Included in that was 1.8 million shares that we sold since March 31st for net proceeds of $18.1 million. The ATM provides us the opportunity to sell registered shares into the open market from time to time under our S-3 shelf registration. We believe that we’re in a healthy cash position with respect to cash resources. Our current cash can fund our operations for at least the next 12 months. I will now turn the call back to Dr. Weisman for closing remarks and the Q&A session.

Thanks, Lucy. Looking ahead to the remainder of 2013, the anticipated results from TRUST-I and TRUST-II and possibly the results from two of the investigator-sponsored studies in psoriasis and autism – these will provide us with a large amount of data on TSO. We look forward to sharing these data with the financial, medical, and scientific communities. And with that I’d now like to open the call up for questions. Operator?

Thank you.

Thank you, Chris.

Right. I was just recently asked that question and I was trying to find out an answer that would be appropriate. I am personally not aware of that being a direct mechanism of TSO. On the other hand, we know that TSO affects pathways of immune regulation and that it is possible – probably through an indirect effect – that an impact would be seen. But I am not myself aware of any experimental evidence that that’s the case but I could be wrong on that, Jay. I guess first of all I’d ask any of my colleagues if they’re aware of a definitive answer to your question, and if not we’ll try to find out. We’ll ask some experts and find out but I’m not aware of that. Any one of my colleagues from Coronado have more information than I do for Jay?

Harlan, this is Karin. No, we do not but that is one of the reasons why we are going forward with our trial where we will be analyzing details such as those.

You’re welcome.

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

Well, I again just want to thank everybody who participated on the call today, the people who asked us questions, those of you who listened in. And we look forward to bringing you further updates as the year goes on and certainly all of us are looking forward to being able to talk about the top line results from the Crohn’s clinical trials, TRUST-I and TRUST-II. Thank you very much and good morning, bye-bye.