Oncternal Therapeutics Inc (ONCT) 2005 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2005 and Yearend GTx Incorporated Earnings Conference Call. My name is Reika, and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will conduct a question-and-answer session towards the end of this conference.

[OPERATOR INSTRUCTIONS]

I would now like to turn the call over to Mr. McDavid Stilwell, Manager of Corporate Communications for GTx. Please proceed, sir.

Thank you, and good morning. On behalf of GTx, I'd like to welcome you to our fourth quarter and yearend 2005 conference call. We released our results earlier this morning through the newswires. If you do not have a copy of the release and want one, you will find it on our website at gtxinc.com. We will have a replay of this call available on our website until March 2nd, 2006.

With me today are Dr. Mitchell Steiner, the Vice Chairman and Chief Executive Officer; Marc Hanover, President and Chief Operating Officer; and Mark Mosteller, Chief Financial Officer. Following this introduction, Dr. Steiner will highlight fourth quarter clinical and corporate development. Next, Mr. Hanover will briefly detail our financial performance for the fourth quarter and full year. Dr. Steiner will then discuss our plans for 2006 and make a few closing remarks. We'll then open the call for questions.

Before we begin, I will remind you that information discussed on this call may include forward-looking statements, and such statement are subject to the risks and uncertainties we discussed in detail in our reports filed with the Securities and Exchange Commission, including in our perspective supplement filed October 12th, 2005 pursuant to rule 424B5. We expressly disclaim any obligation to release publicly any updates to forward-looking statements made during this call.

Now, I'll turn the call over to Dr. Steiner.

Thank you, McDavid. In 2005 we made important strides in setting our Company on the course toward commercialization. We completed enrollment in the pivotal Phase III ADT trial of ACAPODENE, and have shown in the recent planned interim analysis that ACAPODENE 80 milligram builds bone in men on ADT. We are on the verge of completing enrollment of our pivotal Phase III ACAPODENE trial for the prevention of prostate cancer in high risk men. And from our pipeline, we have selected and progressed the first-in-class selective androgen receptor modulator, ostarine, on an expeditious clinical development path.

I would like to briefly highlight 2005's important advances by product candidate. For ACAPODENE 80 milligrams, we completed enrollment of nearly 1,400 men in our pivotal Phase III clinical trial for our cancer supportive care drug to treat the multiple side effects of androgen deprivation therapy in men with advanced prostate cancer. In December, in the interim efficacy analysis of bone mineral density in the first 200 patients to complete one year of treatment, ACAPODENE demonstrated efficacy in treating osteoporosis.

The positive changes of the treated group compared to the placebo group were highly, statistically significant. A positive difference of 2.3 percentage points in the lumbar spine with a P value less than 0.001; a positive difference of 2 percentage points in the hip with a P value equal to 0.001; and a positive difference of 1.5 percentage point in the femoral neck with a P value equal to 0.009.

These results increased our confidence that ACAPODENE should deliver the intended 40% fracture reduction at two years, the trial's primary endpoint. Our interim analysis is the largest prospective study to-date using a SARM for osteoporosis in men with -- on androgen deprivation therapy. Final results from the trial are expected in the second half of 2007.

Urologists and medical oncologists who treat men with advanced prostate cancer are becoming increasingly aware of the serious side effect of androgen deprivation therapy. Much of the heavy lifting to educate physicians on this indication is coming from potential competitors. Amgen is looking at this patient population as one of the many indications for that those are going to have. Novartis' drug, Zometa, of this phosphonate has indicated as a second line treatment for bone met and men on ADT. And Novartis has been educating doctors on the risk of bone complications in this patient group.

We believe that ACAPODENE will emerge as an effective therapy for men on ADT even in a competitive setting. In fact, ACAPODENE has a combination of advantages that the potential competitors do not have. It will be available in a once daily oral formulation. Toremifene Citrate, its active ingredient has a well-established safety record as an FDA-approved treatment for advanced breast cancer. Additionally, only ACAPODENE is being investigated as a potential therapy not only for preventing osteoporosis and fractures, but also for treating most of the other side effects caused by androgen deprivation therapy.

These patients experience hot flashes, gynecomastia, which is the painful swelling in the breasts and adverse lipid changes that can result in cardiovascular complications. We believe that ACAPODENE is able to demonstrate efficacy treating osteoporosis and fractures as well as the other serious side effects of androgen deprivation therapy. It will be well-positioned to be the market leader competing against these other agents, since they only address bone complications.

ACAPODENE 20 milligrams in our pivotal Phase 3 clinical trials for the prevention of prostate cancer in high risk men, we started enrollment in the first quarter of 2005 and had made quick strides towards obtaining our total enrollment goal of 1,260 men by the end of this quarter.

We received our Special Protocol Assessment in the FDA in September, giving us regulatory clarity for this new unmet indication. The FDA specified the size, design and timeline for the trial. It also allowed us for an interim efficacy analysis, the timing of which is driven by the rate of prostate cancer deflection. We believe the required numbers event should occur by the first quarter of 2008. And if the interim analyses demonstrate efficacy, we will be able to file the new drug application.

Here, again, neurologists are becoming better educated in their understanding of high grade PIN as more prospective studies show that men with this condition are indeed at risk for developing prostate cancer. We're doing -- neurologists were doing a better job detecting co-existing cancer with more neural biopsies taken via needles. We're of course taking biopsy. Patients who only have high grade PIN are at risks for progressing to new cancers. Data from multiple studies published or presented through 2005 confirm that men with high grade PIN have a 45% chance of developing prostate cancer within three years of diagnosis and an 80% chance within five to seven years.

Last year, our abstract on our Phase 2b clinical trial was peer-reviewed and selected for Best of ASCO. This abstract summarized the results of our Phase IIb clinical trial in 514 men where ACAPODENE reduced prostate cancer by 48% in men with high grade PIN completed the trials. In non-invasive diagnostic test, we've potentially increased the patient pool on the 1.1 million men in United States were diagnosed with high grade PIN to prostate biopsy. By allowing us to identify high grade PIN in the estimated 14 million men in the United States are knowingly are with this condition.

In 2005, we entered into a collaboration with MacroArray Technologies, to develop a noninvasive diagnostic test for high-grade PIN. In fact, early results of this urine based PIN test that was developed by MacroArray in collaboration with GTx, where we presented at the American Association of Cancer Research's 2006 Annual Meeting in April. Last month, we formed another collaboration with Gen-Probe, for a private program test, to test the ability of one of their research stage diagnostic urine test to detect high-grade PIN.

For ostarine, our pervious clinical development program and our lead SARM, we have completed two Phase I clinical trails. In total a 126 men had now been exposed to ostarine with no drug related serious adverse events. And [inaudible] trail 71 men both healthy young and elderly males, completed 14 days of escalated doses. The measurement of drug activity included changes in fat and lean body mass compartments using DEXA Scans. Ostarine has demonstrated selective anabolic activity without stimulating the prostate or skin. To our knowledge ostarine has now advance [far] through clinical trials than any other SARM under development.

Our plan had been to initiate a Phase II clinical trial of ostarine, for the treatment of severe burns and associated wasting, while we have FDA clearance to initiate this study. Yesterday, the FDA -- the FDA proposed changes to our burn very trial protocol that would extend the length of this study beyond what we originally planned. We chose the burn indication, because it potentially offered the fastest path to commercialization and would provide proof of concept data this summer.

While planning for the burn study, our team was also designing an ostarine study that would provide more comprehensive proof of concept data in elderly men and postmenopausal women, to assess ostarine selected anabolic activity on muscle and bone. This clinical trail will give us a broader array of relevant data to support multiple indication including frailty, osteoporosis and muscle wasting in end stage renal disease patients, and in treatment of severe burns and associated wasting.

GTx has decided it would rather conduct this proof of concept Phase II trial in approximately 120 elderly men and postmenopausal women, given the new timeline proposed by the FDA. The study will evaluate the effects of ostarine on muscle and bone over three months period, and allow GTx to report data in the late summer of 2006. Thus we will achieve our goal of having proof of concept data this summer, and maintain our first-in-class position in this exciting new drug class. On Andarine, our second SARM, with our partner Johnson & Johnson, we're planning a Phase II trails at the end of the year.

Now, I'd like to turn the call over to Marc Hanover.

Good morning. The details of our financial results for the fourth quarter and the full year 2005 are included in this morning's press release and are available on our website. So I will touch on the highlights. At December 31, 2005, the Company had cash and cash equivalent of $74.1 million. The net loss for the quarter was $7.8 million or $0.26 per share. For the full year the net loss was $36.8 million or $1.42 per share. Revenue for the quarter was 646,000 including 312,000 on sales of FARESTON with collaboration income from Ortho Biotech on Andarine providing the balance. Full year revenues were $3.8 million, including $2.4 million in FARESTON sales and $1.4 million in collaboration income from Ortho Biotech.

As for our 2006 guidance, we expect a net loss of between 37 and $47 million. We have no long-term debts, no [warrants]. Based on current spending projections, we believe our cash levels will last through the first half of '07. We are pursuing multiple partnerships to extend our cash runway beyond 2007, to the point that we can see pivotal Phase III data from the ADT trial, to PIN trial, and potentially and ostarine trail.

I will now turn the call back to Mitch.

Thanks, Marc. Looking ahead, 2006 will be an exciting year for GTx. GTx is best known as the PIN Company. And we suspect most of our value is tied to this indication. We're extremely optimistic and excited about being on the leading edge, by developing a medical therapy to treat patients that have a pre-malignant lesions of prostate called high grade PIN.

But GTx is much more then just a PIN Company. We've expanded our ACAPODENE franchise by developing the 80 milligram dose for cancer supportive care with the treatment of multiple side effects, androgen deprivation therapy. The bone mineral density interim analysis helped to grade awareness as for the value of this indication.

As we stated earlier, we believe that as a drug with all those in formulation, and with the potential to treat multiple side effects of ADT, and with a long safety record as an FDA approved breast cancer drug, ACAPODENE is a well positioned to be an effective competitor in prostate cancer supportive care. In regard to our SARM program, I am personally committed to insuring that in 2006, the commercial value of SARMs will become better understood. And we believe that this proof of concept trial will achieve that growth.

Thank you for being on the call. And operator, we are not ready to take questions.

[OPERATOR INSTRUCTIONS]

And your first question comes from the line of Joe Sendek with Lazard Capital.

Hi. Thanks a lot. I have a question on ostarine, specifically the change in the -- do the FDA suggested a change in the length of the burn study, and then you decide just to expand it or the couple of it with the other study am I understanding that correct?

Yes. Right. The answer is that the reason -- just to remind everybody, the reason we picked burns is because we wanted to have a expeditious route to market. And at the same time, we knew that burns would give us limited information for example, only in males, high risk patient, you're looking only at muscle wasting, but it's a good indication because you'll get it to market quicker in a sort of, orphan drug status type indication.

On the other hand, we were actively also pursuing a way that we can get proof of concept data in a broader patient base for example, males and females, muscles and what's happening to bone, what's happening to fat, and that is -- that proof of concept trial also took a period of time that we knew would be sort of summer time.

So when we found out that the burn trail and the proof of concept trial for elderly men and postmenopausal women would basically [fall] out about the same time, it made more sense to us to focus our resources and getting as much information as we can about our drug, because that is the information that can determined what is the possible indications and multiple indications including burns that we can go into.

I mean, we can make -- we may even leap frog, some of the measurements that we would have to take in burn patients by just having a broader study in both males and females. So we think that from a Company's standpoint, it puts us in a good position and when we realize that the timing was not going to be altered, and we're still going to get the data -- Phase II data in the summer, we said look, I think everybody is going to feel better, and understand our drug better, if we had males, females muscle and bones information.

And so the Company made the decision after talking with the FDA yesterday, that even though we got FDA clearance to push forward, we should really focus on this proof of concept trail in elderly. And then, may or may not do the burn stuff depending on how things go with the other trails. And we've left the door open, but I think it strategically makes a lot more sense, in term of getting the comprehensive data that we will need to better understand the commercial value of SARMs sooner rather than later.

Okay. And then, just to put some bookends around the timing here, when will that study start? And then, assuming that the proof of concept data is -- either if your liking, when would a pivotal study start for ostarine?

To kind of, walk you through timing, we expect the trail to start early second quarter. We expect the data to be available in this late summer. We expect to have meetings with the FDA in the fall. And it is our goal, if the indications are appropriate, it is our goals to be in a Phase III pivotal trail by the end of fourth quarter this year, that's pretty much what we've been saying all along with burns. So the only difference now, is we have more potential indications to pick with having better proof of concept data, it's not better, but more comprehensive proof of concept data.

Great. Okay. Thanks a lot.

Thank you, Joe.

And your next question comes from line of Meg Malloy of Goldman Sachs.

Hi. Good morning. I want to follow-up on Joe's question. I'm a little confused as to why, I presume that the FDA had, kind of, looked at the data with burn patients in mind, and it's not clear to me how you can, kind of, switch patients without more discussion with the FDA?

Hi, Meg. Thank you for your question. As you know the FDA has different divisions, and each division pretty much acts independently. We have not closed any doors. So we can still do this trail. We've all along been trying to ask a question, how can we get to proof of concept data soon. And so really this is strategic move to get a greater breadth of data in a broader array of patients. We think it will actually allow us to go back to burn patients. And I'll give you an example.

No. I can understand the desire, because a consumer understands it from the endpoints and who you might ultimately want to treat. And we, kind of, look at burn as maybe to more expedited task, but what I'm confused about is why you would be able to go ahead and start in a different population, then, was originally considered from a regulatory standpoint?

From a regulatory standpoint, we have -- we can start. We have never been told we can't start. So it's not issue what group you're starting. You can -- you know, sometimes you can have multiple Phase IIs going with different divisions. They are independent of each other. So what we are doing is we are saying okay, we can start on this indication, but we're rather starting this other indication that we're thinking about, because it's a research -- resource focusing exercise on how to get as much information about the drug.

So Meg, we haven't closed the door on burns, and all we are doing now, we are saying now is okay, if the timing is such that in one hand I can get data in males, high-risk males or I can get data in males and females and learn about muscle and bone whereas the other one knowing more about muscle and the timing is the same. So let's go with the one, with more bang for our buck, and learn more about our drug. All that does, Meg is leave the door wide open for us to start the burn study anytime, whether we start while we're doing this other the study or we can wait. The main purpose of today's call is to let everybody know that we want to focus our resources on getting more information.

Okay. Thanks. Just what division is reviewing us?

The division that reviewed this is dermatology for burns.

Right. So don't you have to have discussions with -- I don't know, would be the independent division or who would oversee that the--?

What's typically happens is that they'll have consultations with different groups, whether it's ocular, liver or this or that, I'm not saying that's what we had, but typically what happens is that they will bring in whoever they need to to asses, whatever aspect if the drug designed or safety design they are interested in. So the answer is there is a lot -- there is cross talk, but it is in the dermatology division.

Okay. Thanks.

Sure.

And your next question comes from line of Matthew Jacobson of Black Diamond Research.

Hi. Thanks for taking my question. A little more on ostarine, I guess, wondering what exactly sort of is the indication, I mean are you just dosing elderly to get more data or as -- I mean I guess with men you can call it andropause and women osteoporosis. So, is the idea that you really not looking at a specific indication here, and trying get more general information and then could you proceed potentially with multiple, pivotal Phase III trials --?

Absolutely, Matt you hit the nail on the head. And that is that, with a trial of this design it doesn't preclude burns. If anything puts you in great position to continue on these burns, because now instead of doing burns in just males, you can do burns in males and females. So you just doubled the number of potential patients you can put on this trial.

So the concept here is go for the indication of let's say frailty, because you know andropause in men and aging postmenopausal women that would be frailty. And so you do a frailty study, do multiple doses, because it also turn out that hormone in general have -- male to female, have a different sensitivity. So your doses in males may not be same as you doses the female. Females have very sensitive testosterone, men can take testosterone till the cows come home.

So we need to understand this going forward, and the frailty population itself is a $8 billion to $12 billion market. So our thinking is, let's go ahead and do an -- let's go ahead do a Phase II proof of concept study in a potential indication that can give us enough information, for example, you can branch off into postmenopausal osteoporosis [because] your going to get your bone data.

Remember ostarine has the potential not only to be anabolic on bone, but antiresorptive on bone, but also is anabolic on muscle. So this could be a triple whammy where you're protecting bones by building it and keeping it from breaking down, but at the same time you're building muscle which keeps you away from getting fractures.

So we -- so the thinking behind this, Matthew, is at the end of this trial in the summer - that when we're sitting with this data in the summer, we're going to have data in men and women. We're going to have muscle data. We're going to have bone data, so we're going to measure DEXA. We're going to have safety data. So we're going to have -- that's going to be 90-day safety data.

So at that point we can branch into a whole multitude of different indications, anything from indications that GTx can take itself like, for example, burns or end stage renal disease or some of these other [cachexia], or we can start some of these are the indications, for example, like osteoporosis, recognizing down the road that we're going to need to get a partner because those tend to be more extensive trials.

But the difference is we have options. We -- our goal is to understand the commercial value where we can take ostarine. And whereas burns was really exciting, it will be more exciting to open up all the potential avenues that this drug can go into, and let's understand it this year.

And so, Mitch, can you tell us a little bit, I guess, exactly what kind of endpoints you're going to be looking at and what sort of data you'll actually have --

Sure.

...[look forward] to make these decisions?

Sure. So the data is going to be in 120 elderly half men, half women who will be placebo controlled, there will be multiple doses. And the reason we're doing multiple doses, so we can understand a wide range of the drugs effect. We will be measuring body composition by DEXA, which means we're going to see what happens to a lean body weight; i.e., muscle, what happens to fat, because you know with testosterone like agents, fat goes down. So you want to look at lean body weight going up, fat going down, we will measure bone activity -- bone through DEXA, so we'll be able to tell BMD.

Yes.

We will also measure all the hormonal changes that would take place while giving you drugs so you understand -- better understanding of safety.

Sure.

You will also be able to measure bone turnover markers, insulin, all these other things that are related to metabolic syndrome. So that will be measured as well. So at the end of it all, the primary endpoint would be lean body weight -- or the other thing we're measuring is also muscle function and performance. So these are all the things you want to know. Just because muscle goes out, does that mean the performance goes up? You make a women heavier with muscle, is she able to lift those groceries across the kitchen?

Sure.

Okay. So you need to make sure that the increase in lean body weight corresponds to an increase in function. So we're getting that data across the spectrum. The other things you want to know, are for example, anabolic agents, in general, are known to have an effect on cholesterol. So we want to understand what is the effect on cholesterol? We want to understand, what is the appropriate dose in male and what is the appropriate dose in female? So a lot of --you can tell there is a lot of the information that can come out of this study.

Okay. Great. Thanks a lot, Mitch.

Sure.

And your next question comes from the line of [Lehman Brosseau] of SG Cowen.

Hi. Good morning. Thanks for taking my question. Now you're looking at a patient population for the ostarine Phase II, just want to know if you could share with us what sort of baseline characteristics you might be looking forward to [inaudible]?

Okay. So the baseline characteristics of the Phase II study are going to be postmenopausal women. These are women that -- they've been demonstrated to be postmenopausal from a hormonal standpoint. And the second group will be elderly men, and I believe that numbers -- I always hesitate because when I tell somebody what we think elderly is, they get offended. But 60 years of age and older is what's being defined as elderly men. And that's your entry criteria. And it's done by cohorts so this way, you know, it'll be randomized by cohort and compared to placebo. And so the baseline characteristic is going to be more characteristic of an aging sort of frail population.

Okay. Great. And should we expect then subset analysis for different breakdowns of the patients, for example, those with them osteoporosis versus those who have end stage renal disease?

Yes. I mean, this is going to be really cool because it only can do subset analysis -- I mean, first of all the Phase II it allows you a lot more flexibility on the ways you can ask your question. So in addition to, remember the reason you a Phase II is to help you understand, what is the appropriate baseline characteristic you should do in a Phase III to confirm what you found in Phase II. And so that is kind of how we've been approaching this all along.

Great. It's very helpful. Thanks, very much.

And if I can make one more comment. And that is, now you can imagine with this kind of Phase II data, is that you can make decisions about going into other wasting syndrome as well as whether you want to go into female osteoporosis or male osteoporosis or frailty. In another words, all of a sudden now, we just moved the ability to decide, which indications to go into by basically leapfrogging and you can leap frog with a study like this. And not preclude moving forward towards commercialization rapidly, because we haven't -- not continued to entertain burns or other indication that more [would be] more acute.

[OPERATOR INSTRUCTIONS]

And your next question comes from the line of Aaron Reames of Stanford Group Company.

Hello. And thank you for taking my call. I just had a kind of along the same lines and some different questions. What's specifically were the exact changes of the FDA, the dermatology division was looking for or I guess, in another words what were they uncomfortable with as far as that they have seems today and moving into just the burn indications?

First of all thank you for the question. Then if I may say on the issue they were comfortable with it, it's an issue of in a Phase II study in high-risk patients in the ICU. How long do you monitor these patients? So the long we monitor the patients, the long your trials going to be, and so that was the issue. And you know, for us what we wanted to do is to come in and monitor for certain period of time and to follow for a certain period of time.

And where we deferred was they wanted us to file the patients a little bit longer. I think they are absolutely right, it certainly makes sense, it should be done. But what it did do, is it just made the trial longer. So if it makes the trial longer, then it became a business decision, strategic business decision, so okay, if it's going to take same amount of time, then let's go ahead and move to this other trials that we were in plan and get proof of concept in a broader group patients. So that's really the issue.

Aaron Reames Okay. In the proof of concept trial that you're going to be running now, do you feel that it's going to be -- you're looking at a lot of different factors, do you believe it's large enough to find appropriate correlation that will provide you with the basis for designing or well controlled Phase III trial in lets say, osteoporosis or andropause?

We believe so. I mean, you're dealing with a 120 patients, and you are looking at very, very hard endpoints. And for example, anytime you deal with any kind of DEXA endpoint, that's pretty darn [hard]. They are so hard that for example, the osteoporosis trials, you're looking at 2% difference as being meaningful.

So the answer is the primary endpoint is body composition. So we're looking at lean body weight; we're are looking at fat, and were looking at bones. Those are pretty hard endpoints, and then, we started looking at the chemistry like insulin, cholesterol, hormonal changes those are pretty hard endpoints too.

And so we do believe that this will be in the -- on the surface this can continue on as a Phase III frailty trials. On the other -- for the other potentials, my gosh you're showing a BMD changes in women, then, this could be the basis of Phase IIb or with the partner a Phase III [fracture] study. So it puts you in a great position to do two things, one to continue on your own with indications that we can handle, and or, you can leverage the data, and use that to help attract the partners that will be more interested in these much larger indications that, quite frankly, at this point we don't have the resources to do.

Okay. Will you -- from the results of this proof of concept study, will you potentially go into -- I guess a Phase II trial in burn patients at that point in time to still get specific data, or would you believe that you would have a enough data to move in to a Phase III setting? How does it change your perspective in that regard, or you just, kind of, throwing out the idea of looking at burn patients as a specific indication in a label?

No. No, I think, it's -- I think the answer is that we believe that the results in this trial, the proof of concept trial in elderly men and women will give us, I'll say it a different way, will allow us to broaden our approach in burns. So that instead of doing just male burn patients, you can do male and female. You'll have the better understanding what a dose differential will be because males are more -- less sensitive than females.

So we're not throwing out the idea of doing burns at all. What we are saying to ourselves is that it probably makes sense to allow us to move quicker in burns if we have more data about the compounds. So our thought is, well, let's get the more data about the compound, and then, based on that take a pause, look at a data in summer time, and then make a decision of where the indication or indications that we want to move forward.

Okay.

So the beauty of it is that you're going to have a whole host of data, that in some cases will let you Aaron and move forward to -- for example indications that are broader, and in some cases you can move in to the more premium indications, that are going to be sure that we can take forward ourselves all the way to the NDA in market. So that if we kick off a Phase III program, it still puts us in a position to potentially have a data, and file and NDA in the same timeframe, that burns initially would have allowed us to do.

Okay. And then, just the last question, I was wondering if you could provide just a little bit more detail, on the status of some of the diagnostic tests for high-grade PIN, particularly, focusing on, I guess, the progress that MacroArray is making --?

Yes. Yes, what, I can't tell you because the abstract, of course, is confidential until it's public in spring. But I can't tell you that MacroArray technology, which is one of the five companies that we're -- that we have collaborations with. The way we collaborated with these companies is we provide them samples from our Phase IIb studies. And we're providing them samples from our Phase III study for PIN. And what MacroArray has done and a beautiful job, is they have identified a protein that is unique to PIN appears not to be found in prostate cancer or benign in tissue.

As you know prostate -- PIN and prostate cancer really different in sense that PIN hasn't invaded yet, for some reason it hasn't invaded yet. So it's one cell layer away from being invasive carcinoma. So the only way these cells can [slough off] and be detected, it is go down the duct and, end up in urethra, and if it's in the urethra then it get washed up the urine. So this company has a urine-based test that is looking at these cells in the urine, it's not post-prostate massage, it's literally first [inaudible]. And then they -- this protein is evidently, the sensitivity the specificity in this small cohort is showing that they're able to detect PIN.

Interestingly, they are at point a now where they've already created polyclonal antibodies. So it's like an [inaudible] base test. And these are the data we'll see in the [spring]. We are very, very excited about that and continue to support MacroArray. In the mean time some of these other diagnostic companies are basically taking their - tat least two of them were taken their prostate cancer tests, which are complicated prostate cancer tests and trying to see whether or not a different fingerprint occurs when they look at the protein profile in PIN for example. But the one was most promising to us is MacroArray Technology.

Okay. Thank you for the questions.

Sure thing.

And your next question is a follow-up from the line of Meg Malloy of Goldman Sachs.

Meg?

I am sorry. Thank you for the follow-up. Mitch could you remind us what dose you studied with ostarine in the Phase I, and to the extent you can elaborate on dosing that you would expect to study? And then overtime do you think this is a product that you would switch to the endocrine division or how do you see the -- ?

Yes.

Just from an FDA perspective. How --

Sure, sure.

How do you see the progression?

Sure. Appreciate that. First of all the doses that will -- first of all this drug is very potent drug and in the Phase I setting we tested as high as 30 milligrams. And in the Phase II setting, we are going to be testing as low as 0.1 milligrams a day to as high as 3 milligrams a day. And so this way gives you the range.

In terms of the FDA, again it depends on the indication, so if we go into -- it's interesting the FDA in this regard, if we go into an indication like, let's say frailty, osteoporosis, you would go to metabolic. If we go into now for example you're Andarine into cancer cachexia you would go to oncology. If you want to treat burn patients you would go into -- if you want to treat burn patients you would go to dermatology. If we decide to go after acute -- excuse me -- end stage renal disease we would be in nephrology.

So they all going be different, no question that we are going to have cross talk between division, but you're earmarked into specific divisions based on what is the indication going after. So we would imagine that the divisions that we will have to most view with are going to be oncology, metabolic and dermatology.

Just to be clear, why are you comfortable that you will be able to start this study in the second quarter, does is not entail additional review by the FDA at the metabolic division?

I see what your saying. The reason we're clear is because we did our Phase I studies in [Belfast] - I think it's Belfast I don't know. So we are doing our Phase II study, which is already previously planned in elderlies in Hamburg and also in Belfast. So it's under a [CTX]. And in the United States, we would get in -- we would have to get an IND with metabolic. Having said that, metabolic has reviewed as a consultant the data from -- for the burn trial, and has already weighed in and we had FDA clearance to push forward. It's just became a timing thing.

Okay. Thanks. That's very helpful.

Sure.

Ladies and gentlemen, this concludes your question-and-answer session for today. I would like to turn the call over to Dr. Steiner for any closing remarks.

Thank you, Operator. We would like to thank you all for your interest in GTx, and we look forward to providing you with updates on our future progress. Thank you again for joining us on today's call.

Ladies and gentlemen, thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Have a great day.