Larimar Therapeutics Inc (LRMR) 2014 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to Zafgen's fourth-quarter full-year 2014 financial results call. please note that this call is being recorded. At this time I would like to turn the call over to Kimberly Ha of FTI Consulting for introductions and opening remarks.

Welcome and thank you for joining us for Zafgen's fourth-quarter and full-year 2014 financial results conference call. Today you will hear from Dr. Tom Hughes, Chief Executive Officer, who will give an overview of the Company's 2014 and recent achievements. Dr. Dennis Kim, Chief Medical Officer, will provide a clinical update; and Patty Allen, Chief Financial Officer, who will discuss Zafgen's financial results.

After the formal remarks management, including Patrick Loustau, President, and Alicia Secor, Chief Commercial Officer, will be available to take your questions.

Before we begin I would like to remind you that the estimates and other forward-looking statements included in this call represent the Company's view as of today, March 19, 2015. Zafgen disclaims any obligation to update these statements to reflect future events or circumstances.

Please refer to today's earnings release as well as Zafgen's filings with the SEC for information concerning factors that could cause actual results to differ materially from those expressed or implied by such statements. Please also note that this call is being simultaneously webcast online. I will now turn the call over to Dr. Tom Hughes. Tom.

Thanks, Kimberly. Good afternoon and welcome to our fourth-quarter and full-year 2014 earnings conference call. 2014 was truly an outstanding year for our Company.

With the successful completion of our IPO in June and our subsequent follow-on offering in late January 2015 we are in a stronger financial position than ever to continue our mission to bring life-changing treatments to patients affected by obesity and complex metabolic disorders and to the physicians who care for them.

In 2014, and in the second half particularly, we made significant progress in the clinical development of our lead product candidate, beloranib, achieving multiple significant clinical milestones across our key indications. In September we initiated our Phase 3 trial of ZAF-311, known also as the bestPWS trial, which stands for beloranib efficacy safety and tolerability in Prader-Willi Syndrome or PWS.

PWS is a rare complex metabolic syndrome characterized by hyperphagia, or insatiable hunger, and obesity resulting at least in part from impaired functioning of the hypothalamus. Our work in this patient population has brought us one important step closer to the first commercial indication.

As a Company we are committed to doing our very best to advance beloranib and to understand its utility as an effective treatment option for patients and families living with this devastating condition.

In December we initiated our Phase 2b trial, ZAF-203, which is evaluating beloranib in patients in the general population with severe obesity complicated by type 2 diabetes. We continue to be very excited by this opportunity as the trial aims to determine the long-term impact of beloranib on body weight and will allow us to assess the compound's potential to impact medically important co-morbid conditions such as type 2 diabetes.

More recently in January we announced positive results from a Phase 2 clinical trial, the ZAF-221 trial, of beloranib in patients affected by hypothalamic injury associated obesity, or HIAO. Similar to PWS, no effective treatment options are available for the management of obesity in HIAO patients.

We presented the promising results of this study at the Endocrine Society annual meeting in San Diego earlier this month and look forward to discussions with regulatory agencies to chart a path forward in this indication.

These three important clinical activities position us well for the coming year as we expect clinical readouts from our Phase 3 bestPWS trial as well as from ZAF-203 in late 2015/early 2016. Our Chief Medical Officer, Dr. Dennis Kim, well discuss all of this as well as the HIAO data from January in greater detail shortly.

Before I discuss additional highlights from the quarter I would like to talk a little bit more about beloranib and our view of the therapeutic potential of the MetAP2 inhibitor class.

Beloranib is a highly potent inhibitor of methionine aminopeptidase 2, or MetAP2, an enzyme that modulates the activity of key cellular processes that control metabolism. MetAP2 inhibitors reduce the production of new fatty acid molecules by the liver and help convert stored fat into useful energy while reducing hunger.

The mechanism of action for beloranib being effective in peripheral tissues of the body is expected to function similarly across the indications we are currently evaluating. These include PWS, HIAO and severe obesity in the general population.

Zafgen leads the field in developing MetAP2 inhibitors having validated the therapeutic impact of the approach in six completed clinical trials including over 200 patients. These trials have shown impressive weight loss, often up to a kilogram per week, with a wide range of improvements and cardio metabolic biomarkers.

The results from these trials have guided us toward attractive market opportunities for beloranib and our second-generation compounds in obesity-related orphan indications, severe obesity in the general population and nonalcoholic fatty liver disease, or NAFLD, and nonalcoholic steatohepatitis, or NASH.

Before I turn the call over to Dennis for a detail clinical update, I'd like to share a few additional highlights from the fourth quarter and some recent activities.

This past Tuesday, March 17, we received notice from the us patent office that one of our key patents has issued. This patent covers the twice weekly dose regimen for beloranib. Uncovering the surprising potency, efficacy and tolerability of the non-daily or twice weekly administration regimen we are using with beloranib was a major [inventive] step in our program and we are delighted to have this patent, which will expire in 2029, issued this week.

This now gives us two issued patents covering our dosing regimen both expiring in 2029. We also had a patent issued last year for a composition of beloranib contributing further to our growing intellectual property estate.

In December Zafgen was added to the NASDAQ Biotechnology Index. This Index is designed to track the performance of a set of securities listed on NASDAQ and we are very pleased to add the list of great companies on that index.

We have continued to establish leadership in the MetAP2 space through a number of presentations and publications. We presented our PWS trial results at the Obesity Week annual conference in November and we are pleased to have our ZAF-201 severe obesity Phase 2a trial manuscript accepted and published recently in Diabetes, Obesity and Metabolism.

As you will hear, we presented our HIAO data at the Endo Society annual meeting this month. We also have had three abstracts from our Phase 2a studies across PWS, HIAO and severe obesity indications accepted at the European Congress of Obesity meeting later this year with the HIAO abstract being accepted for an oral presentation.

We are continuing to build a best-in-class Company and are attracting high-caliber candidates. We now have 24 employees and recently made several key appointments. These include heads of medical affairs, biology, pharmacology and toxicology, drug substance manufacturing, IT and quality. We have also grown our clinical functions to support our clinical trial program.

Now I would like to turn the call over to our Chief Medical Officer, Dr. Dennis Kim, for more details on our clinical development program. Dennis.

Thanks, Tom. As Tom noted earlier, we made significant clinical progress with beloranib in recent months. In December we initiated our Phase 2b trial in patients with severe obesity complicated by type 2 diabetes, or ZAF-203. Thus far we have seen significant interest in terms of patient enrollment and remain optimistic that we will meet our timeline goal of enrolling all 150 patients by the middle of the year.

As a reminder, this trial is a randomized double-blind placebo-controlled study of twice weekly subcutaneous injections of beloranib at doses of 1.2 milligrams or 1.8 milligrams in severely obese adults that aim to demonstrate efficacy and safety over a 6- to 12-month period along with improvements in glycemic control.

The primary efficacy endpoint is change in total body weight from baseline to the end of randomized treatment. Key secondary endpoints include changes in glycemic control, lipid parameters and inflammatory markers. Additional assessments include sense of hunger and quality of life impact for patients. We continue to expect 6-month interim data late in 2015 or early 2016.

Weight reduction is a key therapeutic objective in the clinical management of patients with type 2 diabetes and is perhaps the most challenging aspect. Most available agents drive less weight loss in obese patients with type 2 diabetes relative to patients without diabetes. Clearly more effective agents are needed and we are excited to focus the ZAF-203 trial in this population.

The study will help us better understand how effective MetAP2 inhibition can be in this population and will help inform our next steps, whether we choose to advance beloranib or a second molecule in this severe obesity indication. We will announce when we have completed this trial -- completed enrollment of this trial.

Let's turn our attention to an update on the Phase 3 PWS trial or ZAF-311 also known as bestPWS. As a reminder, this is a double-blind placebo-controlled trial of placebo 1.8 or 2.4 milligrams of beloranib. To make sure we are all on the same page, we also want to remind you that we updated the dual primary efficacy endpoint for this trial earlier this year which are reductions in body weight or hyperphagia-related behaviors.

As you may recall the original dual primary efficacy endpoints were reductions in total fat mass or hyperphagia-related behaviors. The trial is being conducted across 15 sites in the United States and I'm happy to report that all 15 sites are now activated and enrolling patients.

As a reminder, the target enrollment number was increased earlier in the year from 84 to 102 patients to leverage enthusiasm from patient community and to increase the power of the trial for both efficacy and safety readouts should the trial become the basis of an earlier filing. We currently have enrolled over two-thirds of the total patient target for this trial, which is a bit slower than initially anticipated.

To keep up the pace of recruitment we are working closely with the Prader-Willi Syndrome Association and the Foundation for Prader-Willi Research patient advocacy groups to raise awareness and we have anticipated in -- participated in multiple webcasts to inform prospective patients and their families about the trial. We very much appreciate their efforts and continued support.

We're also lowering the BMI requirement for enrollment to 27 from 30 kilograms per meter squared as we are aware of patients who have slightly lower BMIs that still have hyperphagia-related behavior and are still overweight and would otherwise be excellent candidates for the trial. This is consistent with input we received from US and EU regulatory agencies.

We have also opened access for Canadian patients to participate in the trial. We've had a lot of interest from Canadian families and we are happy to be able to open the study to these families into the US study sites.

With regards to patient retention in the study, we are pleased to have had significantly fewer early dropouts from the study than was modeled in our [prior] calculation. This speaks to the commitment that our participating families have for the study and the excellent trial conduct by our contributing clinical study sites.

In summary, although it is taking a bit longer than we expected to enroll the full cohort of 102 patients, we believe the trial will be very robust with this greater number of patients, especially when coupled with a higher patient retention rate. We now believe that we will be reporting results from the ZAF-311 trial by Q2 2016, likely by early Q2. We will provide an update on our progress at the time we complete enrollment of the trial which we expect in the coming months.

Recently the Data Safety Monitoring Board, or DSMB, reviewed the unblinded data set and recommended that it is appropriate to move forward with a 2.4 milligram dose to treat all patients in the open label extension of the trial. This is important because the DSMB has confirmed that the 2.4 milligram dose thus far has demonstrated unacceptable safety and tolerability profile.

With respect to our second pivotal trial, ZAF-312, we are on track to initiate the trial for PWS in Europe in mid-2015. This trial is designed to enroll approximately [650] patients with PWS and, like ZAF-311, has dual primary efficacy endpoints of reduction in body weight or hyperphagia-related behaviors.

We now expect to test just the 2.4 milligram dose in this trial at least in part based upon the decision from our DSMB in the ZAF-311 trial as just mentioned. The trial is expected to be conducted at 25 sites across Europe. We have a lot of enthusiasm from the KOL community and investigators in Europe and are looking forward to initiating the study. We will also plan on announcing its initiation when it occurs.

Changing gears to hypothalamic injury associated obesity, or HIAO, in January we announced positive results from ZAF-221 on randomized double-blind placebo-controlled Phase 2 proof of concept study of beloranib in 14 adults with HIAO. This trial evaluated the efficacy, safety and tolerability of 1.8 milligrams of beloranib administered as twice weekly subcutaneous injections for four weeks followed by an optional four-week open label extension.

The trial enrolled 14 patients with a mean age of 31.9 years, body mass index of 42.9 kilograms per meter squared and body weight of 126.4 kilograms. All patients had radiographic evidence of hypothalamic damage with documentation of subsequent rapid and significant body weight gain. Patients were not counseled to adhere to any diet or exercise regimen as part of the trial.

Results from this study showed that after four weeks of treatment patients randomized to beloranib lost an average of 3.4 kilograms of body weight versus 0.25 kilograms placebo, which reached a significant level of P equals 0.01.

Results from the open label extension suggested no apparent waning of effect a beloranib with longer treatment with total body weight loss of 6.2 kilograms for patients who received drug for the 8-week period.

Furthermore, known markers of beloranib response, including major cardiovascular risk factors such as plasma LDL cholesterol, triglyceride and C-reactive protein, were also improved with beloranib treatment.

In this Phase 2 study there were no early discontinuations due to adverse events, severe or serious adverse events in patients receiving beloranib. In addition, no clinically significant abnormal laboratory measures, vital signs or electrocardiograph cardiography or ETG findings were observed.

The most common adverse events occurring in more than one patient treated with beloranib were dizziness, headache and nasopharyngitis. These were generally mild and transient in nature. The results of this proof of concept study are important as they show that beloranib has a unique mechanism of action which mediates weight loss through means independent from a fully functional hypothalamus.

Importantly, weight loss in patients with HIAO was similar in magnitude to weight loss we have seen in conventionally obese patients in our prior studies. This supports are emerging view that MetAP2 inhibition has the potential to provide robust efficacy in a broad range of patients regardless of the etiology of their obesity.

We have a very busy 12 months ahead of us and we look forward to keeping you apprised of our clinical progress over the coming year. With that I will turn the call over to Patty who will take you through our financial results for 2014.

Thanks, Dennis, and good afternoon, everyone. As Tom mentioned at the top of the call, this has been an important quarter and a significant year for us, both in terms of progress with our beloranib clinical program and our overall growth as a recently public Company. Today I will focus on full-year 2014 results, but the details for the fourth-quarter results are included in our press release.

To date we have not yet generated any revenue. For the year ended 2014 we reported a net loss of $36.5 million or $3.00 per share compared to a $14 million net loss or $19.53 per share for the year ended December 31, 2013. The weighted shares outstanding used to compute net loss per share were 12.2 million shares for the year ended 2014 compared to 729,000 shares in the year ended 2013 which was prior to our IPO in late June 2014.

Our operating losses were primarily driven by research and development costs associated with our beloranib development program as well as beloranib-related milestone payments and general and administrative expenses, including costs associated with being a publicly traded company.

We had 22.9 million shares outstanding as of December 31, 2014 and we issued 3.9 million shares at the end of January related to our follow-on offering.

Moving to research and development expenses, for the year ended December 31, 2014 R&D expenses increased $17.8 million to $27.4 million compared to $9.6 million for the year ended December 31, 2013. The increase was primarily due to costs of $13.9 million associated with the advancement of the Company's beloranib program, $1.3 million associated with ZGN-839 and other early stage development programs consisting of our second-generation MetAP2 inhibitors.

A significant part of the increase in R&D expenses for beloranib in 2014 were incurred in Q3 of 2014 and related to milestone payments, primarily the CKD Pharma of $7 million due to the achievement of milestones related to the initiation of a first Phase 3 clinical trial in beloranib, which the Company initiated in September 2014. The milestones to CKD were paid 50% in cash and 50% in Zafgen stock in the fourth quarter of 2014.

As we look forward to 2015 for R&D expenses we expect to see a significant increase in expenses as we will have three clinical trials running, the ZAF-311 bestPWS Phase 3 trial, the ZAF-203 Phase 2b trial in severe obesity in the general population and the zap 312 Phase 3 trial in Europe for PWS.

We will also be building our ZGN-839 program in NASH to an IND in mid-2015 and bringing forth multiple backup molecules to beloranib during 2015. We will also continue to significantly grow our team in R&D where we will nearly triple the size of the team as we build out our regulatory, quality, clinical, project management and supply chain groups, among others, for Zafgen.

Moving on to general and administrative expenses, as we expected and previously communicated, G&A expenses for the year ended December 31, 2014 increased and were $8.1 million compared to $4.2 million in the year ended 2013 primarily due to increased personnel-related costs of $1.9 million for positions added to support our growth as a publicly traded company. We also saw increased public company costs, professional fees, travel and other related costs of approximately $2 million period over period.

As we look forward to 2015 for G&A expenses we expect to see a significant and continued increase in G&A expenses as we will be growing our team in G&A as well and we will be a public company for the full year in 2015. We will also be starting to grow our commercial organization and begin market research and market access work in anticipation of success with the bestPWS clinical trial.

With respect to our cash position, as of December 31, 2014, we had cash and cash equivalents and marketable securities totaling $115.5 million. We completed our follow-on public offering on January 28, 2015, which raised net proceeds of approximately $130 million, based on the public offering price of $35 per share and after deducting underwriting discounts and commissions.

Therefore our pro forma cash balance including the January offering as of December 31, 2014, was approximately $245 million. We expect that this cash position will be sufficient to fund our current operations for at least the next 18 months. We expect that our cash balance at the end of 2015 will be greater than $145 million.

With that I will turn the call back to the operator for questions. Jonathan?

(Operator Instructions). Joseph Schwartz, Leerink Partners.

Congratulations on the progress. I was wondering if you could just talk a little bit more about some of the reasons for the slower enrollment in the bestPWS study. I guess it is a little bit surprising given we've sensed a lot of demand already for the drug in the community.

Dennis?

Yes. So, I would say that probably the most significant reason for the slight delay is the amount of time it took to activate all the study sites. These are all -- all 15 study sites are academic study sites and having IRB approval at local IRBs -- ethics committee that is, and then having contracts through the contract offices at all 15 sites took longer than anticipated.

And I also wanted to remind you that we are enrolling patients, as was recommended to us by the regulatory agencies, to enroll patients with moderate to high level of hyperphagia. And so, being able to document that and to select from these patients also took a little bit longer than we had anticipated.

Okay. That is helpful. And then did your screen failure rate differ from what you expected once you got the IRB approvals up and running?

I would say no, but we've -- this is the first time that a Phase 3 trial for Prader-Willi Syndrome patients has ever been run in the United States. The only exception is the growth hormone trial that has been run in the past, which was an open label study and uncontrolled. So that is a little bit of an apples-to-oranges comparison.

So there was really no good way of anticipating what the screening failure rates would be or what the enrollment rate would be. The only thing we had to compare it to was our Phase 2 study that we ran at University of Florida Gainesville with Dr. [Jennifer Miller].

And in that we obviously enrolled the study pretty quickly because it was just one site and we only needed 17 patients. So there was really not a lot to compare it to to try to model what the screen failure rate would be.

Okay, that makes sense. And then congratulations on the recent positive data in HIAO. I was wondering if you could help us understand a little bit more about the difference between drive to eat and hyperphagia now that you have got positive data in a few different or a couple different orphan obesity settings. It seems like there is a different profile for the drug and also perhaps the patients themselves.

Yes, that is a great question. It is a subtlety we saw in this HIAO trial that we didn't anticipate. Just to clarify, patients with HIAO don't have the same type and level of hyperphagia that patients with PWS have.

So patients with HIAO, although they in general consume more calories than they need and their metabolic rate is low, and this all leads to severe obesity. They in general -- of course there are exceptions -- but in general they do not manifest pathologic hyperphagia such as going through trash to get food or eating nonfood items. That is fairly specific for PWS patients.

So we didn't measure -- we didn't use the same hyperphagia questionnaire that we are using for the PWS trials. What we did use was an eight question visual analog scale questionnaire that asks about patient's sense of hunger and patient's sense of prospective food intake among other things.

Whereas we have seen convincing reduction in sense of hunger and sense of prospective food intake in prior trials that we have run with conventional obese patients. In this study, and in the HIAO study, with a caveat being that it is a small trial over short duration, especially for a subjective measure such as sense of hunger that's self-reported.

We did see a different pattern read out in that there wasn't a big -- a significant change in sense of hunger, but there was still a significant reduction in sense of prospective intake -- food intake. And what that suggested to us is that perhaps these two senses may be controlled by different centers in the brain.

Such that patients without a fully intact or functional hypothalamus may not be able to sense their level of hunger as acutely or as sensitively as patients with an intact hypothalamus. And we are excited about this phenomenon because I think it's teaching us as and the field something new about where food intake is controlled versus where the hunger sense exists in our central nervous system.

Okay, great, fascinating. Thanks for taking my questions.

Simos Simeonidis, RBC Capital Markets.

I just want to clarify what I heard I think Tom or Dennis say about the 312 European trial. Did you say that you are only going to test the 2.4 mg dose? And if I heard correctly, could you elaborate a little more on that rationale?

Dennis?

Yes, you heard correctly and this is a recent update for us. And it is mostly as a result of our Data Safety Monitoring Board from the US Phase 3 trial adjudicating that 2.4 milligrams was appropriate to take forward as the only dose for the open label extension part of that study.

As you know, we are testing 1.8 milligrams and 2.4 milligrams in that study. And what that tells us and confirms is that 2.4 milligrams has an acceptable safety and tolerability profile. And the main reason -- additional reason why we are taking 2.4 milligrams just into the European study is to really increase the power of that study by just using one comparator versus placebo.

Since we feel comfortable that 2.4 is being well-tolerated and appears safe so far, we would rather err on the side of increasing the power and ensuring high probability of technical success in that study.

So, the size for the -- or the end for this trial is going to remain the same, it is you're going to have two instead of three arms?

That is exactly right.

Okay. And was this something that was in the protocol along your planning to wait to see the DSMB guidance from the US trial? And if that was going to be positive you were planning to make this change or this is a recent development?

This is something that we have been thinking about all along, but without supportable data it is a decision we couldn't have made until now. And so with recent DSMB adjudication we decided to -- we decided that we have enough information to make that change for the European study.

Great. So the DSMB comment that you got, was there anything in there in terms of the efficacy of the drug or the 1.8 dose in particular or no?

No, I mean the -- we are -- first of all, we are [low] to give any more details about the discussions that occurred at DSMB. I think suffice it to say at this point that 2.4 milligrams is looked upon favorably by DSMB and that is why we are taking that forward.

Okay. A final question is in the 311 trial to speed up recruitment you mentioned that you are going to lower the entrance requirement I believe from 30 to 27 in terms of BMI. I know the drug has not been tested in that many patients in the two positive trials you had in PWS and HIAO, [you've even] grouped them together, the 31 patients.

But is there enough data or enough evidence in your mind to think that in that patient group or if you take a patient group that is less -- that has a lower BMI, 27 to 30, for example you are not risking in any way being able to show the efficacy you have shown in the past?

Yes. Our prior analysis of the results that we've seen in other trials suggest that patients even between BMI of 27 to 30 should respond similarly because there is no waning of weight loss effect across different BMI categories.

But let me just emphasize that these are going to be just a handful of patients with that BMI range between 27 and 30 that will be coming into the study to buttress enrollment. And that this isn't likely to meaningfully change the baseline body weight at -- on an average basis in the study.

So, we don't anticipate that this is going to change things very much. It will hopefully just help us reach a normal target a little bit quicker.

Okay, great, thank you very much for taking the questions.

Jason Butler, JMP Securities.

Just had a follow-up about the HIAO population and how you are thinking about the hunger end points now. And specifically how you are thinking about using the data you collected from the proof of concept trial and translating that into endpoints for a pivotal study?

Maybe I will take a quick stab at that, this is Tom, Tom Hughes. So I think with respect to the endpoints for HIAO, to maybe answer the back end of your question, we need to have this conversation with the regulatory agencies.

What we do know from our conversations with physicians who are treating this patient population is that weight is really the signature issue that affects these patients, it is what prevents them from having a reasonable life. And we know that they are intractable with regard to their weight gain and they don't respond to other agents so there is a very, very high level of unmet need.

So our anticipation is that the HIAO trials will focus on body weight and body weight reduction and that that may be the key to success there. I'll just remind you we saw perhaps one of the cleanest impacts on body weight that I think anyone has ever seen with a weight loss agent in such a small study with the 221 trial. And so we feel very good about the results that we got there and the likelihood that they will be repeatable in Phase 3.

Now the question around hunger and how it relates to these patients, I think Dennis answer that to a certain extent. But our view is that we need to understand more in the longer-term about how these different brain regions work. And so the HIAO patient is really providing us really what is the first window into the potential for other brain regions really to be sensitive to pharmacologic treatment?

And this is something that we are really very excited about pursuing. And I would say that we have had just an overwhelming response from our opinion leaders or our scientific advisors with regard to the potential scientific impact of these findings. So we are really excited about it. I am not sure if I answered your question, but that's that.

No, that is helpful, thanks for taking the question.

(Operator Instructions). Phil Nadeau, Cowen and Company.

Hi, this is Jeff on for Phil. A question on the EU trial for PWS. So there have you identified most of the patients or enough patients for the trial?

Yes, we have engaged many of the key opinion leaders and investigators in Europe across several countries. And we are modeling a number of sites we need and the number of patients we need to recruit per site per month to come up with our plan for enrolling 150 patients in time.

And so, that work is ongoing, it is almost complete. And that's the main reason why are still guiding to initiating the study by the middle of the year and completing enrollment as planned.

Thank you, that's helpful. And one follow up question on the general obesity. So I think before you discuss you have a go or no go decision by looking at the interim data year end, so what are the factors and what are you looking for in determining that?

I think obviously the extent and the rate of weight loss out to six months will be an important factor along with the safety/tolerability signals that we see. We are studying 1.2 and 1.8 milligrams of beloranib in that study and then of course glycemic parameters will be important.

If we are able to confirm in the study as we anticipate, that the drug is able to deliver unprecedented weight loss and glycemic improvement in terms of pharmacotherapy, I think these will be important factors for us deciding whether to go forward with a severe obesity indication.

Now the main question there will be -- at that point the main question may become do we do that with beloranib versus another compound in our pipeline. So that is another decision to be made at that point.

Thank you, that is very helpful.

Thank you. This does conclude the question-and-answer session of today's program. I would like to hand the program back to Dr. Hughes for closing remarks.

Great. Well, I'd like to thank everyone for joining our fourth-quarter and full-year 2014 conference call. As I said earlier, this has been a truly exceptional year for us and we are really very excited about our future and looking forward.

As we move through the rest of 2015 into 2016 we look forward to sharing new data with all of you from our beloranib clinical trials. And we remain committed to significantly improving the health and well-being of patients affected by obesity and related complex metabolic disorders and look forward to updating you on our further progress on our next call and throughout the year. Enjoy the rest of your day. Thank you.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.