Larimar Therapeutics Inc (LRMR) 2015 Q2 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to Zafgen's second quarter 2015 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 second quarter 2015 financial results conference call. As noted on slide 2, today you will hear from Dr. Tom Hughes, Chief Executive Officer, who will give an overview of the Company's second quarter and recent achievements; Dr. Dennis Kim, Chief Medical Officer, who will provide a clinical update; and Patty Allen, Chief Financial Officer, who will discuss Zafgen's second quarter financial results. The slides provided for this call can be accessed at www.Zafgen.com. After their formal remarks, management, including Patrick Loustau, President, and Alicia Secor, Chief Commercial Officer, will be available to take your questions.

Before we begin, on slide 3 is a reminder that the estimates and other forward-looking statements included in this call represent the company's view as of today, August 11, 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 second quarter 2015 earnings conference call. We've had another productive quarter in which we continue to execute on our mission to bring life-changing treatment to patients and families affected by obesity and complex metabolic disorders. As you can see on slide 5, which is an overview of our programs, we are continuing to advance our pipeline of MetAP2 inhibitors.

On the call today, Dennis will give you an update on our clinical progress, including our work in our most advanced indication, which is Prader-Willi Syndrome, or PWS. I'm pleased to say that with patient enrollment completed and the fact that we are continuing to see a lower-than-expected dropout rate in ZAF-311, our first Phase III trial, we are looking forward to reporting top-line data in early Q1 of 2016. The work we continue to do in this patient population brings us even closer to our first commercial indication, which represents an important milestone in our Company's history.

We now have positive proof of concept in two rare disease indications, PWS and hypothalamic injury-associated obesity, or HIAO. In the coming months we'll be initiating ZAF-312, our second pivotal trial in PWS, a study focused primarily in Europe. We are also working to solidify our regulatory path and next steps in HIAO. Our Phase IIB trial, ZAF-203, which is evaluating beloranib in patients in the general population with severe obesity complicated by type II diabetes, is enrolling well. Dennis will give you an update on that in a moment.

Along with leaders of the medical community treating patients with obesity, we continue to be very excited by this opportunity, as the ZAF-203 trial aims to determine the long-term impact of beloranib treatment on body weight, and will allow us to assess beloranib's potential to impact medically important comorbid conditions, such as Type 2 diabetes. Patients with Type 2 diabetes generally respond poorly to weight loss agents and glycemic control is more challenging to manage in the setting of obesity. This combination of obesity and Type 2 diabetes affects an alarming number of patients, for whom better treatments are desperately needed.

Physicians are challenged to manage care of these patients, who are at greatly increased risk of developing complications that are both life limiting and very expensive to treat. We believe that the profile of our MetAP2 inhibitors may be uniquely suited to treatment of this challenging patient segment, and we're eager to see what the ZAF-203 trial brings with longer-term beloranib treatment over 6 at 12 months period.

Regarding our NASH, or nonalcoholic steatohepatitis compound, ZGN-839, I want to provide an update on the IND we discussed during last quarter's call. As we wait for final results from our panel of animal studies, we now expect the IND for ZGN-839 to be filed slightly later than initially expected. Our current expectation is that we will file in the fourth quarter of this year, 2015, instead of by September as we had previously stated. ZGN-839, discovered at Zafgen, is an intriguing molecule, being a very potent and selective MetAP2 inhibitor that targets the liver. We anticipate seeing strong effects of this compound on liver fat content, liver inflammation, and additional end points including improved glycemic control in patients impacted by both NASH and Type 2 diabetes.

Similar to obesity in Type 2 diabetes, physicians who treat NASH have told us that patients with NASH and concomitant Type 2 diabetes are more likely to exhibit rapid progression of their liver disease and are seemingly less responsive to available agents. We are very excited by the prospect of advancing ZGN-839 into clinical testing and are working to develop a thoughtful and highly informative clinical approach to this compound. We look forward to updating you as we move to the clinic.

Looking at slide 6, we continue to grow our Company and our presence in the Boston area. We have hired an additional 15 employees since last quarter, bringing our total to 40, and continue to attract experienced and high-caliber candidates. One of our recent hires, Dr. Kevin Malobisky, our Head of Global Regulatory Affairs, brings us impressive knowledge of drug registration in the area of metabolic diseases, and has worked closely with both the metabolism and endocrinology and gastrointestinal divisions at FDA over the course of his career. Kevin is working with our team to further broaden our international -- internal regulatory capabilities and already has had substantial impact on our planning and interactions with various regulatory agencies.

Finally, before we get into the details of this quarter, I wanted to highlight a recent discussion within the oncology community that I believe helps underscore the importance of our work in obesity and the clinical advancements we are pursuing with beloranib. As you can see on slide 7, the Journal of Clinical Oncology -- which, as many of you know is the Journal of the American Society of Clinical Oncology, or ASCO -- published a position paper in October of last year highlighting a continuing increase in evidence linking obesity to cancer risk and outcomes. This publication and ASCO's intention to address obesity took center stage during this year's ASCO meeting in May.

Obesity is a major unrecognized risk factor for cancer and is rapidly moving to overtake tobacco as the leading preventable cause of cancer. According to ASCO, obesity has been associated with worsened prognosis after cancer diagnosis, can negatively affect the delivery of therapy, contributes to the morbidity of cancer treatment, and can raise the risk of second malignancies and comorbidities as well. Several mechanisms have been suggested as explanations for the link between obesity and increased risk of certain cancers. For example, adipose tissue can produce excess amounts of estrogen, which has been associated with the risk of breast, endometrial, and other cancers.

People with obesity also have hyperinsulinemia due to insulin resistance. And insulin, a growth factor, may promote development of tumors, which has also been associated with increased cancer risk -- so insulin has also been associated with increased cancer risk. Fat cells also produce adipokines, which can stimulate or inhibit cell growth and may be linked to tumor cell aggressiveness. Despite the increased evidence linking obesity and cancer, few states ensure coverage of recommended treatments for adult and pediatric obesity through Medicaid or private insurance. And only a minority of state Medicaid programs seem to cover all recommended obesity treatment modalities for adults.

ASCO is urging the Centers for Medicare and Medicaid Services, or CMS, to add obesity to the list of chronic diseases eligible for the proposed complex chronic care management services payments. It also is encouraging the Department of Health and Human Services, or HHS, to clearly define access to obesity treatment services in the new state healthcare exchange plan. At the very least, ASCO is urging HHS to consider obesity as a serious medical condition, worthy of protection under Department regulations regarding pre-existing conditions or discriminatory benefit design.

If you recall, in 2013, the American Medical Association declared obesity a disease, which caused a significant amount of controversy. The AMA is a respected physician association but they alone cannot change how we think and talk about obesity and we welcome ASCO's engagement in this dialogue. There is a paucity of effort being directed to the discovery and development of new therapies for obesity, and funding for research into the physiologic and molecular basis of obesity is very limited. That's why our mission at Zafgen is more urgent than ever to bring life-changing treatments to patients and families affected by obesity and complex metabolic disorders.

And now I'd like to turn the call over to our Chief Medical Officer, Dr. Dennis Kim, for a detailed update on our clinical development program. Dennis?

Thanks, Tom. As Tom said, we have had a quarter of encouraging clinical progress for our beloranib program. Moving on to slide 9, on our last call we announced that we had met our planned enrollment target of 102 patients for our US Phase III trial of beloranib in Prader-Willi Syndrome, also known as ZAF-311 or bestPWS. We are very pleased that since then we have enrolled a total of 108 patients across 15 sites, which exceeds our normal target. We are very excited about the enthusiasm we've seen in the patient community for this trial and we see this upsized trial as an opportunity to increase the power of the study for both efficacy and safety readouts, as a basis of a potential early regulatory filing.

As a reminder, bestPWS is a six-month trial consisting of randomized, double-blind, placebo-controlled, twice-weekly subcutaneous injections of 1.8 milligrams or 2.4 milligrams of beloranib or placebo in 108 patients with PWS. The primary efficacy endpoint for this trial -- endpoints for this trial are hyperphagia-related behaviors and body weight. Secondary endpoints include changes in total fat mass, body fat mass, lipid profile, C-reactive protein, or CRP, which is a marker of systemic inflammation, and quality of life.

As Tom mentioned earlier, we are happy to note that we continue to see lower than expected drop out rates in this study, which speaks to the commitment we've seen from participating families and the overwhelming support we have received from the PWS community and the advocacy groups, and apparent tolerability of both doses of beloranib. With completed enrollment and high patient retention rate, we remain on track to report top-line data from this study in early Q1 2016.

Let's turn to ZAF-312 on slide 10, our Phase III clinical trial for PWS and our second pivotal trial. This trial is designed to enroll approximately 150 patients with PWS, primarily in Europe, which we plan to complement with sites from Canada and the US as well. We expect to have 40 to 45 sites across 8 to 10 countries participating in this trial. The trial will also have co-primary endpoints of reduction in body weight and hyperphagia-related behaviors. And it is expected to test just the 2.4 milligram dose, partly based on the safety and efficacy evaluation by the DSMB from ZAF-311. The two-part 4 milligram dose will be initiated after four weeks of 1.8 milligrams twice weekly in an attempt to optimize tolerability.

As we have worked to initiate ZAF-312 in Europe, we concluded that there are many benefits to be gained from adding sites in the US and Canada. First, we are using ZAF-312's study to bridge results obtained in the US trial for the sake of the EU review. Given that ZAF-311 has a six-month readout, whereas ZAF-312 has a 12-month readout, having a small number of US patients will help strengthen the fidelity of the bridge between the studies. Secondly, we have had tremendous demand and interest from the US and Canada-based patient groups to have more opportunities for patients to participate in beloranib clinical trials. Lastly, by opening additional sites in the US and Canada, we will ensure access to a larger number of patients, enhancing our ability to complete the trial more rapidly. We will communicate our progress for this trial in the coming months.

Let's discuss ZAF-203, which is on slide 11. ZAF-203 is our Phase IIb trial of beloranib in patients with severe obesity who also have Type 2 diabetes. We are very excited to be running this study, in which we aim to show significant and continued weight loss and an impact on glycemic control in this difficult to treat patient population. ZAF-203 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, that aims to demonstrate efficacy and safety over a 12-month period, with an interim six-month analysis. Patients were randomized to receive 1.8 milligram dose will receive four weeks of 1.2 milligrams of beloranib at the start to help mitigate any potential sleep disturbances or other tolerability side effects.

We continue to see significant patient interest in this trial and have enrolled greater than 95% of the patients. We have seen a very encouraging retention rate in ZAF-203 and expect to complete patient enrollment of all 150 patients later this month. The primary efficacy endpoints of ZAF-203 is change in total body weight from baseline to the end of randomized treatment. Chief 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 six-month interim data and a subset of 95 patients late in 2015 or very early 2016.

Slide 12 shows the baseline characteristics of this robust subset, which reflect a patient population that is poorly controlled, at high risk of developing serious medical complication, and has been found to respond poorly to all other anti-obesity agents. The subgroup consists of 54% women and 46% men, with an average age of 54 years. Their mean BMI at baseline is 38.4 kilograms per meter squared. Average body weight is 111 kilograms. Mean baseline A1C is 8.4% and their mean fasting glucose level is 194 milligrams per deciliter. We look forward to seeing if beloranib treatment can drive weight loss and improvements in glycemic control comparable to bariatric surgery in this difficult to treat patient population.

This has been a very productive quarter in terms of our clinical program and we're looking forward to even more progress in the second half of 2015. With that I'll turn the call over to Patty Allen, our CFO, who will take you through our financial results for the quarter.

Thanks, Dennis, and good afternoon, everyone. As both Tom and Dennis mentioned, we've had a busy and productive second quarter and are now gearing up for the second half of the year. Today I'll focus on our second quarter results, which are highlighted on slide 14. For the second quarter of 2015, we reported a net loss of $17.8 million, or $0.66 per share, compared to a $6.4 million net loss, or $2.96 per share, for the three months ended June 30, 2014. The weighted shares outstanding used to compute net loss per share were 27 million shares for the three months ended 2015 compared to 2.2 million shares in the second quarter ended 2014. Just as a reminder, we completed our IPO in late June 2014.

Our operating losses were primarily driven by research and development costs associated with our beloranib development program, and general and administrative expenses including costs associated with being a publicly-traded company and increased professional fees, primarily commercial readiness activities related to PWS. We had 27.1 million shares outstanding as of June 30, 2015. Moving to research and development expenses, for the three months ended June 30, 2015, R&D expenses increased to $12.5 million compared to $4.7 million for the three months ended June 30, 2014. This significant increase was primarily due to costs of $3.9 million associated with the advancement of the Company's beloranib program, primarily clinical costs related to the ZAF-311 bestPWS Phase III trial, ZAF-203 Phase IIb trial in severe obesity and Type 2 diabetes, and start up costs for the ZAF-312 Phase III trial for PWS. There was also an increase of $1.9 million associated with our ZGN-839 program for NASH and our second-generation MetAP2 inhibitors.

We also had an increase in personnel related costs of $1.6 million, as we have increased our headcount over the past number of quarters, as Tom mentioned earlier. As we look forward to the second half of 2015 for R&D expenses, we expect to see a significant ramp up in R&D, as we will have all three clinical trials running that I just mentioned. We will also be moving our ZGN-839 program in NASH to an IND and bringing forth multiple second-generation molecules to beloranib during 2015. We continue to significantly grow our team in R&D, where we will nearly double the size of the team by the end of the year, as we continue to build out our regulatory, quality, clinical, CMC, program management, and supply chain groups, among others, for Zafgen.

Moving on to general and administrative expenses, for the three months ended June 30, 2015, G&A expenses were $5.1 million compared to $1.3 million in the three months ending June 30, 2014, primarily due to increased personnel related costs of $1.5 million for positions added to support our growth as a publicly-traded company and as we prepare for commercialization of PWS. We also saw increased travel and professional consulting fees of approximately $2.3 million period over period. As we look forward to the remainder of 2015 for G&A expenses, we expect to see a ramp up in G&A, as we will be growing our team and we will be a public company for the full year in 2015. We have started to grow our commercial organization with three hires this year and are preparing for commercial readiness for the PWS program.

With respect to our cash position, as of June 30, 2015, we had cash, cash equivalents and marketable securities totaling $220.1 million. We expect that this cash position will be sufficient to fund our operations for at least the next 18 months. We continue to 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 all the progress. I was wondering, you mentioned lower dropout rates in the bestPWS study than you expected. Was there anything else to explain how you ended up over-enrolling bestPWS in a shorter amount of time than you expected? Was there any deviations in things like screen failure rate or a larger number of sites than you initially expected?

This is Dennis Kim. It was mostly logistics that drove that overall number of 108 patients. And we had previously also mentioned that after bringing on a couple of sites that are high enrollers at the tail end of the recruitment process, they really caught up and allowed us to enroll all the patients in an earlier than expected projected timeline. We ended up enrolling 108 versus 102, not as a result of protocol deviations or differing screen failure rates, but mostly as a result of patients being in the queue for screening and we did not want to turn them away. So we erred on the side of including those patients, as long as we didn't meaningfully delay the recruitment completion.

Okay. And then somewhat related, I was wondering how you are feeling about site training for the Phase III bestPWS study, and maybe if you could compare that to what you saw in the Phase II.

Yes, it's a pretty different study, a Phase III versus Phase II, mostly because Phase II was a single-site study in a specialized, dedicated PWS group home, whereas this is done -- conducted mostly out in the real world. And it's a 15 study site center. Having said that, we did take a lot of care making to -- ensuring proper training of each of the study site personnel, as well as administering study drug and some of the important study procedures, like body weight measurements, administration of hyperphagia questionnaire, as well as DEXA scans that's going to measure total fat mass and total lean mass.

As an example, we have a vendor that is -- that trains every single technician that the DEXA scan machine will be utilized in each of the study sites. And we make sure that they can do one sample DEXA scan run and have to qualify before we can activate their site as a DEXA scan site. So we take a lot of care in making sure that systemically and systematically these sites are trained consistently across the board.

Okay. Then maybe one more before I turn it over to others. Can you give us an update on the HIAO development? Have you had an opportunity to meet with the FDA and nail down the design for Phase III HIAO development? How might that differ from PWS? If at all.

Sure. This is Tom Hughes. So, there are three I would say ongoing work streams that we're carrying out for HIAO, to get going on that. One is essentially establishing orphan designation. The second is working with KOLs in the space to really understand what would be the drivers, the key levers that we would wish to have in the Phase III program, so that when we speak with FDA that we will have those things locked down. In other words, what are the key features of the data set that we really want to generate. And then lastly is the FDA and EMA dialogue itself.

So I think all we are saying at this point is that those are all in stream and that we'll update you as soon as we have something that's meaningful. And I guess you asked also about the size and timing of those trials. I think that all will stem from those conversations and we'll let you know that we are looking at this as a very important work stream for us in the coming months. And we are eager to be able to give you a little bit more color on all that when the time is right.

Great. Thanks for taking my questions.

Phil Nadeau, Cowen and Company.

First, on the bestPWS Phase III trial, do you have a sense of how compliant the participants are with the bodyweight measures and hyperphagia questionnaires? Is that information that you get similar to the dropout rate? Or is that something that has to await the database cleaning and lock?

Yes, that's something we look at on a regular basis. We constantly audit each of the study sites and the paperwork that they generate to make sure compliance rate is high on an ongoing basis. And what I can say without sharing exact numbers is that it's meeting our expectation as to what type of compliance we would want to see in a pivotal trial.

Okay, great. And on the dropout rate, you said it's lower than your expectations is. Can you give us a sense of what those expectations were and perhaps where it's trending?

Yes, understanding this is a moving target, because as patients continue to go through the trial they can always discontinue at any time. We had built-in 18% dropout rate as part of the power calculation assumption. So, roughly speaking, with 102 patients or now 108 patients, that would translate to about 20 patient dropout assumption. And again, without sharing exact numbers, because things are going to change, we are well south of that.

Got it, okay. On 839, can you maybe talk a little bit more about why the IND is in Q4? Is it simply the [ML stage] are taking a little bit longer to complete? Or is there any additional work that you need to do that you hadn't anticipated?

It is largely just what you mentioned. So we -- the rate limiting step for this is getting the histology back from one of our longer studies. We built a recovery period into that study that is basically what's taking the extra time. Histology is also taking a little bit more time than we had expected. You are probably aware of this, but there's a lot of demand on contract organizations these days and so there's pressure on getting things done at a lot of these sites. Beyond that, everything is on track and I think we are looking at a good outlook for getting things done in time. We are actively writing everything right now, so it should be just a matter of weeks really is what we're talking about here.

Okay. And just one last question on the European pivotal trial. Why is the endpoint on that one 12 months compared to the six-month endpoint in the US?

Sorry, just to clarify, you are asking why the endpoint is at 12 months versus six months?

Yes.

Yes, what's the rationale for the difference in duration?

Yes. It was based on a couple things. It was based on feedback from key opinion leaders that patients in Europe may be more amenable to having a 12-month follow-up in a blinded setting. But more importantly, it was driven by our regulatory interactions with the FDA, who stated that they would like to see 12 months of control data. And as you know, with ZAF-311, we will produce 12 months of exposure, drug exposure data, but it will be six months of controlled and a six additional months of uncontrolled setting. So we just wanted to make sure that we are delivering on what the FDA has told us they wanted to see.

So do you now anticipate needing the EU study to file in the US? Or is it still possible to file just on the US trial?

Well, our base case is that both studies will be needed to conduct the filing or be ready for filing. It really will come down at the end of the day to the merits of the 311 data package. If it's sufficiently compelling in our view and if we can reach some reasonable handshake with the agencies around that, then we will proceed with a filing on 311. But that remains to be determined.

Great. Thanks for taking my questions and congratulations again on all the progress.

Simos Simeonidis, RBC Capital Markets.

On the ZAF-203 trial, have you found that implementing the titration of the first month of 1.2 and then going to the 1.8 has helped with the sleep disturbance issue?

I think -- we can -- all I can speak to, because the study is still blinded and we are not able to discern who is on drug versus placebo -- all we can speak to is the number of overall adverse event rates we're seeing. Again, not knowing who is on placebo and drug, and also the dropout rates due to adverse events. And comparatively -- again, going back to ZAF-201 trial where we didn't institute a dose titration scheme and also we had utilized a little bit higher dose in that study -- so it's a little bit apples to oranges comparison. But I think, based on what we know about the drug and what we would've expected, I think so far the signs are positive that it is working out as we would hope to see.

Okay. And I assume there have been interim safety looks in the study up to this point.

Yes, we looked at -- we look at safety data on an ongoing basis. Again, that's in a blinded setting, without knowing who is on drug and who is not. We do also have DSMB or safety review committee meetings that meet on a regular basis, and they look at the data in an unblinded setting. We don't as a practice share the results of those. I think the detailed results of those meetings, but suffice it to say that the study is continuing as initially planned. And there's been no alterations made as a result of any safety issues.

Okay. great. That's very helpful. And then my next question was on the 95 patient subset, again on the same study. Is there something special about this group? Or is this the first 95 patients that were enrolled, and you're just describing their characteristics. You've isolated them because they are the first 95 patients in the study? Can you talk about that group?

Yes, it is what you said. It's the first 95 patients that were enrolled, and that allows us to deliver on the six-month interim analysis at the end of this year or very early next year. Our projection is that this demographic or baseline characteristic profile we provided during the call today is going to be very similar to the overall baseline characteristics for the entire 150-patient cohort. We don't expect that to change very much. There is nothing special about these 95 patients that we are doing a subset analysis on, with the exception that they were the first ones to come into the study.

Okay, great. And final question, where are you with second-generation beloranib?

This is Tom. So that -- the second gen program is actually coming along really well. We are essentially at the point now where we have -- without getting too much into detail, we have a number of candidates that we are moving forward. You may recall from our earlier conversations that we are really looking to find compounds that provide two improvements, if you will -- improvements of note, anyway -- over beloranib, one being an improved cost of goods, an easier synthetic process. And the second being a broadening of the therapeutic index or a widening of the therapeutic index with respect to embryo fetal development affects, or teratogenicity.

And so, we have compounds that look like that, that have I would say very impressive pharmacologic profiles, and those compounds are being moved along. And we'll give an update as we get a little bit closer to IND for those.

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

(Operator Instructions). Jason Butler, JMP Securities.

I'll add my congrats on the progress. Just in terms of the European or PWS trial, can you talk about whether there is, in your mind, any threshold or limit of patients that you want to have from the US and Canada? I.e., is there a number that European regulators want you to have enrolled in Europe?

In other words, are we trying to fill some sort of quota for Europe? Is that basically the question? Or was there another --? Yes, okay.

Exactly.

Yes, our plan has been to enroll 150 patients in Europe. Patients in Europe, obviously there are cultural issues that we have to get across in terms of language that we use for hyperphagia-related behavior, as well as perhaps some food handling differences in the homes. But it's really the -- as long as we enrolled the vast majority of patients in Europe and complement that with a handful of patients in US and Canada, it's to -- there's no real quota to meet per se, but really primarily to be able to bridge the two studies in more of a head-to-head fashion in terms of patients in North America versus European patients. Instead of trying to do it across studies in 311 versus 312, as well as to maximize our chances of finishing the study in time with more patient access and more countries and more investigators.

Okay, great. Thanks, Dennis. And then just a question on 839, acknowledging that the Phase I study next year is primarily PK and safety, will we get any data or will you look at any markers in that trial that could speak to biologic activity that's relevant to NASH?

This is Tom. We're not yet describing the trial design, but if there's one thing that we know about MetAP2 inhibitors is that they provide an incredibly rich source of biomarkers; clinical biomarkers that we find to be very relevant, both to the disease state but also to drug action. And so we'll be collecting, let's say, quite a bit of information both from our single ascending dose and the multiple ascending dose components of that early set of trials. So, the -- yes, the answer is yes, tons of biomarkers and things that we know and appreciate as being very, very representative of MetAP2 inhibitor action.

Okay, great. Thanks for taking the questions.

Christopher James, FBR Capital Markets.

Let me add my congrats on the progress this quarter, and thanks for taking my questions. Most of which have been answered. I just have one question on 203. Remind me, will you be capturing any metrics on behavior-related changes? And do you really expect to see any effect on eating behavior related to mechanism in these patients?

I think the most relevant behavior markers that we'll be tracking will be really the drug's impact on sense of hunger and prospective food intake. We'll be asking other questions, but those are two specific markers of eating behavior we have been able to discern from prior trials. And we'd like to document that it still is ongoing at six months and one year follow-up. That will really be mostly around eating behavior. We'll also be tracking quality-of-life impact as it relates to body weight. So that's the only other part. Did I answer your question?

That's helpful. That answers my question and thanks again, guys.

(Operator Instructions). This does conclude the question-and-answer session of today's program. I'd like to hand the program back to management for any further remarks.

Okay. Well, I'd like to thank everyone again for joining our second quarter 2015 conference call. It's been a very productive and busy quarter for us and we have a data rich 4 to 5 months ahead of us, for sure. We have a number of exciting milestones for our development programs and we look forward to sharing new data from our beloranib clinical trials, most notably ZAF-311 and ZAF-203. 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. So, enjoy the rest of your day. Thank you for your attention and goodbye.

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