Logo
Log in Sign up


← Back to Stock Analysis

Earnings Transcript for FBIOP - Q3 Fiscal Year 2012

Executives: Dr. Lucy Lu - Chief Financial Officer Dr. Bobby Sandage - President and CEO Noah Beerman - Chief Operating Officer Dr. Karin Hehenberger - Chief Medical Officer Dale Ritter - Chief Accounting Officer
Analysts: Joe Pantginis - Roth Capital Partners Boris Peaker - Oppenheimer Megan Dow - MLV & Company
Operator: Good day, ladies and gentlemen. And welcome to the Coronado Biosciences’ Third Quarter 2012 Results. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at time. (Operator Instructions) As a reminder, today’s conference call is being recorded. I’d now like to turn the conference over to your host, Dr. Lucy Lu, Chief Financial Officer. Please go ahead.
Dr. Lucy Lu: Great. Thank you. Good morning, everyone. Thank you for joining us. This is Lucy Lu, Chief Financial Officer for Coronado Biosciences. Thank you and welcome to our third quarter 2012 financial results conference call. Before we begin, I’d 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 Factor section of our quarterly report on Form 10-Q for the third quarter ended September 30, 2012 and in the company’s other filings with SEC. With that, I’d like to turn the call to Dr. Bobby Sandage, President and CEO, who will begin the presentation. After which I’ll provide you with the summary of the financial results for the company. Bobby?
Dr. Bobby Sandage: Thank you, Lucy. Thank all of you for joining us this morning for Coronado Biosciences earnings call to discuss the financial results for the third quarter 2012 and I’ll also provide an update on the development of our various programs. With me on the call today in addition to Dr. Lucy Lu is Noah Beerman, Coronado’s Chief Operating Officer; Dr. Karin Hehenberger, our Chief Medical Officer; and Dale Ritter, our Chief Accounting Officer. Our lead product TSO or you may know it is Trichuris suis ova, its currently being evaluated in two Phase 2 clinical trials for the treatment of Crohn’s disease. One of these trials which we refer to is TRUST-I is being conducted by us here in United States and other one TRUST-II is being conducted in Europe by our development partner, Dr. Falk Pharma Company. In addition, we are supporting a selected number of investigators conducting studies in other autoimmune diseases. Our other product CNDO-109 is an immunotherapeutic product for the treatment of cancer and our initial focus is on the acute treatment of acute myeloid leukemia or AML. During the third quarter we continued to improve the financial position of the company. In August, we completed a $15 million debt financing deal with Hercules Technology Growth Capital and in few minutes, Lucy will review the terms of that deal and the impact of this additional cash to our balance sheet. In past quarter, we also welcome Dr. Harlan Weisman y to our Board. Dr. Weisman brings over 20 years of experience as a Senior Healthcare Executive and position responsible for the development, regulatory approval and launch of innovative biopharmaceutical medical device and diagnostic products. Dr. Weisman is the former Chief Science and Technology Officer for the J&J Medical Devices and Diagnostics Group, as well as the former Company Group Chairman, Research & Development for Pharmaceuticals at J&J. As you know, its one of the leading companies with products in the field that’s [implant to valve disease]. All right. Now back to the back pipeline. During the third quarter, we continue to advance the development TSO. During second quarter investor call, we told you that we are working on our clinical study sites in IRBs to be in a position to initiate the TRUST-I during the third quarter. In fact, we did initiate that trial in August as promise and enrollment is progressing very nicely. As a reminder, this trial is a double blind, randomized, placebo-controlled study intended to enroll partially 220 Crohn’s patients. We expect to have approximately 65 sites throughout the United States participating in this study and anticipate releasing topline results in the second half of 2013. I also mentioned that we are collaborating with Dr. Falk Pharma Company in the development of TSO for Crohn’s disease. We are very encouraged in April when an independent data monitor committee for that study provided a positive recommendation from an interim analysis conducting on the first 120 patients enrolled in the study. We expect this committee to conduct another analysis following the enrollment of approximately 250 patients, which based on the current projected enrollment rates should occur mid-2013. Data from both of these Phase 2 studies will provide key efficacy and dosing information to support the Phase 3 program for TSO in Crohn’s disease. You may recall that TSO has a unique mechanism reaction, which we believe is immune modulation and not immune suppression, respiratory affording many serious side effects that are known to be part of immune suppression. Because of this, we believe and expect that this mechanism is universal across many autoimmune diseases. So in addition to the ongoing trials in Crohn’s disease, there are many and there are several investigator-initiated clinical trials already ongoing and many more plans in a variety of other autoimmune diseases. Coronado is supporting these investigator-initiated studies with a product supply, in some cases graphs and has been instrumental in prioritizing the study indications, selecting the sites and investigators, assisting in the design of the trials and providing regulatory advice. Because of our effort, I’m happy to report that several of these studies have now been initiated and have started enrolling patients, including for example, an ulcer colitis trial being conducted at NYU, which we announced in August and a trial in adults with autism spectrum disorder being conducted at Montefiore hospital, New York, we just announced earlier this week. In addition, there are two ongoing multiple sclerosis trials and we plan to evaluate TSO in a number of other autoimmune diseases, including sclerosis, rheumatoid arthritis, psoriatic arthritis and Type-1 diabetes, with many of these trials being or scheduled to initiate in early 2013. The first U.S. clinical trial for CNDO-109, our immunotherapeutic product for cancer is on the verge of starting. CNDO-109 is a proprietary tumor cell membrane lysate that activates the body’s own natural killer or NK cells. We now have IND approvals to begin treating patients with AML at several of the clinical sites and plan to start screening patients this month. In August, we announced the granting of the First U.S. Patent for the core Patent Covering CNDO-109. The claims broadly covering activating tumor cell preparations tabled, claiming the NK cells to kill tumor cells, including tumor cells previously resistant to NK cell license for killing. The issuance of this patent is central to our intellectual property portfolio around CNDO-109 and we are very excited to have it in place and we prepared to begin the clinical enrollment of this compound in the treatment of oncology in many of these patient groups. Earlier this year, we also were granted a patent in Australia and we continued to prosecute this or other patents for CNDO-109 throughout the world. Now, I’d like to turn the call back over to Lucy to review the financials for the third quarter.
Dr. Lucy Lu: Great. Thank you, Bobby. During the third quarter, we secured a $15 million loan from Hercules Technology Growth Capital. The loan was fully funded at closing and provides us with additional capital to support our clinical program. The loan carries an interest rate of approximately 9.25% and is due payable in installments over 42 months, including an initial 12 months interest-only period. We ended the quarter with $47.5 million in cash where we believe we will be sufficient to fund our operations into the first quarter of 2014. I’d like to now turn to our P&L. Our net loss in the third quarter ended September 30, 2012 was $5.9 million, compared to the net loss of $3.4 million in the third quarter ended September 30, 2011. This increase is primarily due to the increased in research and development expenses associated with our increased clinical trial activity. R&D expenses were $3.8 million versus $1.8 million for third quarter 2011, primarily related to our TSO program. G&A was $2.1 million this quarter, up from $1.8 million for the 2011 third quarter, primarily due to increased staff and related costs. Our net loss in the nine-month period ended September 30, 2012 was $19 million, compared to a net loss of $29.6 million in the same period ended September 30, 2011, a decrease of $10.7 million or 36%. Included in the 2011 net loss was $20.7 million charge for in-process R&D related to our acquisition of TSO. Excluding this expense, our loss in the nine-month period ended September 30, 2011 was $8.9 million, which consisted almost entirely of R&D and G&A expense. Our net loss in the nine-month period ended September 30, 2012 is $10 million. We’re 112% greater than our loss in nine months period ended September 30, 2011 excluding the in-process R&D expense. R&D increased $7.8 million consistent with the change between the three months period. This increase is primarily due to increase TSO development process, which included a $3.4 million payment to Dr. Falk Pharma. G&A was up $2.2 million primarily due to increase staff and related cost. We used $16.1 million of cash in operations in nine months period ended September 30, 2012, which included a $3.4 million of payments to Dr. Falk Pharma. We express our quarterly loss and quarterly cash burn to increase in the coming quarters as our clinical trials in TSO at CNDO-109 increased patient development. We filed $75 million Shelf Registration Statement in September when we became actually eligible. Included in that is the $30 million asset market issuance to our ATM facility with MLV that we intent to access only opportunistically to supplement our cash position. I will now turn the call back to Dr. Sandage for closing remarks and Q&A session.
Dr. Bobby Sandage: Thank you, Lucy. So the results from the two Phase 2 Crohn’s studies and possibly those in psoriasis and autism should make and could make the second half of 2013 a daily rich time for Coronado. The recent debt deal, we have a stronger balance sheet which will help us to continue to execute on our business plan. We will have cash into the first quarter of 2014 by which time we expect to have topline results from both the phase II studies at TSO in Crohn’s disease. As you can see, ’13 been exciting time for Coronado Biosciences and we sincerely appreciate your support. Look forward to meeting with many of you in New York City during that Piper Jaffray conference in November, with our Oppenheimer Conference in December. Well, I thank you for taking the time this morning to listen to our 2012 third quarter call. Operator, I’ll now like to open it up for questions.
Operator: (Operator Instructions) Our first question comes from Joe Pantginis of Roth Capital Partners. Please go ahead.
Joe Pantginis - Roth Capital Partners: Hi. Good morning. Thanks for taking the question and congratulations on the progress.
Dr. Bobby Sandage: Thanks, Joe.
Joe Pantginis - Roth Capital Partners: Bobby, TRUST-I started in August and you’re expecting data in second half of ‘13 topline data. So that could be considered relatively rapid. You did allude to the call that enrollment is progressing nicely. So just wondering maybe can you provide some, may site feedback or anecdotes regarding physician interest as well as garnering patient interest as well?
Dr. Bobby Sandage: Yeah. It’s still early but we have over half the sites that have drug on site that are screening patients. And it’s actually been in those sites that are up and running. It’s been pretty easy to recruit the patients there. They are looking for alternatives especially with some of the more powerful immunosuppressants. So we’re getting a lot of interest from the sites and the patients because they are looking for alternatives.
Joe Pantginis - Roth Capital Partners: Now that’s very helpful. Thank you. And then just, from a manufacturing standpoint, can you just remind us your ability to manufacture product for these studies as well as any future plans if you look to go into a pivotal studies?
Bobby Sandage: Yeah. We have sufficient supplies to easily give us through the Phase 2 program. And we’re in the process as we speak of scaling up the manufacturing so that we will be way ahead. In fact, we’re going to be ready for Phase 3 probably six months ahead when we would actually start the Phase 3 daily. So, we are right on track and the scalar process will give us through, we believe, the first couple of years of commercialization. So, things right on schedule. We’re planning for success and there should not be any hiccups here at all.
Joe Pantginis - Roth Capital Partners: Okay. Thanks a lot guys.
Dr. Bobby Sandage: Thank you, Joe.
Operator: Our next question comes from Boris Peaker of Oppenheimer. Please go ahead.
Boris Peaker - Oppenheimer: Good morning. Can you hear me?
Dr. Bobby Sandage: Yeah. Hi, Boris. Thank you.
Boris Peaker - Oppenheimer: Thank you for taking my question. So, my first question is what can we expect from the Dr. Falk interim analysis? Specifically, can we increase patient number or make any other adjustments to their study?
Dr. Bobby Sandage: Yeah. The short answer is yeah. The independent data mark still has the same broad mandated, had at the first interim analysis. However as you know we’ve had many discussions about the assumptions that in the modeling that we get. And we believe there is a very good chance the study will stop at the -- if what they saw at the first interim continues, the study could stop at the -- this next interim analysis. But they have the -- still the broad mandate stocking for futility, changing the arms or adding patients to the study that’s all possible. Our assumption is that given the precision that was offered to the companies in their recommendation than it’s a good chance. We will stop with a positive finding.
Boris Peaker - Oppenheimer: Okay. That’s very helpful. Now, on TSO and multiple sclerosis, I think we haven’t talk much about that in a while. I just want to know what can we expect for the buy market data from the HINT-2 study or when specifically can we expect that?
Dr. Bobby Sandage: So, we understand the Dr. Falk has completed enrollment. So he has around 21 patients now total you add in the five and additional 16 approximately. We -- the patients are being treated for 10 months. So, we are expecting data sometime probably the early prog of 2014 from that trial.
Boris Peaker - Oppenheimer: Right. And my last question I think it’s probably more directed to Lucy as you mentioned that in some of the investigator response in trial you guys give grants. I just want to get a sense of how much are we talking about here, let’s say, over the next year in 2013 or whatever reasonable time period you would like to use?
Dr. Bobby Sandage: But I will take that, Boris. These are very nominal grants because most of these sites are getting outside funding. And so if they need to cover some small pieces of the cost of the study we’re offering grants to help on manage the cost of an IRB and the cost of particular tool from measurements that sort of thing. These are nominal cost. The most expensive piece which is easily managed by us is the supply of the TSO.
Boris Peaker - Oppenheimer: Okay. You give like a cap in the period of year. It’s under $1 million or under some…
Dr. Bobby Sandage: Way under a $1 million.
Boris Peaker - Oppenheimer: Okay. Well, thank you very much for taking my questions.
Dr. Bobby Sandage: Sure. Thank you, Boris.
Operator: (Operator Instructions) Our next question comes from Megan Dow of MLV & Company. Please go ahead.
Megan Dow - MLV & Company: Hi, everybody and thanks for taking my questions and congratulations on moving forward.
Dr. Bobby Sandage: Hi, Megan. Thank you.
Megan Dow - MLV & Company: Hello. We are just -- I'm hoping that you have a little bit more CNDO-109, how you are thinking about enrollments and how the screening for these patients is going to be underway. It looks like its pretty restrictive first, how much of these characteristics these patients mean to me and now you’ve talked for some of the physicians at these places fair with their input?
Dr. Bobby Sandage: Yeah. In fact, the 10 sites that we are selected to participate or selected not only for their expertise in this particular area but they have the patients that we want. We do need patients and complete remission reliant within a certain period of time. And so the recruitment is going to be a little bit tricky but preliminary feasibility work with the sides, we think that -- in fact we know from the first few sides that we ready to go. They have patients that they can start screening literally any day now as soon as we are ready to pull the trigger with the sale processing fees and it will happen before the end of this month.
Megan Dow - MLV & Company: Okay.
Dr. Bobby Sandage: But…
Megan Dow - MLV & Company: Great. And do you have any estimates for when those some enrollment would be happening?
Dr. Bobby Sandage: Well, it’s a little tricky to predict that because this is a dose escalation protocol. So you dose the first patient. You have a number of weeks that you have to wait, see how they tolerate it and you get to dose two more and if that’s tolerated and then you can go up, if you don’t then you have to expand it. So, it’s been little bit tricky. We think we’ll have some idea about the tolerability at least through the first couple of cohorts maybe our three cohorts by the middle of next summer. We will see at maybe third quarter. And…
Megan Dow - MLV & Company: Okay. Perfect.
Dr. Bobby Sandage: And so we will see.
Megan Dow - MLV & Company: Great. Thank you.
Dr. Bobby Sandage: You are welcome.
Operator: (Operator Instructions) I'm showing no further questions and I’d like to turn the conference back over to management for any closing remarks.
Dr. Bobby Sandage: Thank you. And just again I want to thank everybody for participating and listening in. If you have any follow-up questions, of course, you can reach out to any of the management team here. We’ll be glad to try and answer any one-on-one. Thank you very much. Thank you, Operator.
Operator: Ladies and gentlemen, this does conclude today’s conference. You may all disconnect. And have a wonderful day.