Oncternal Therapeutics Inc (ONCT) 2007 Q2 法說會逐字稿

Good day, ladies and gentlemen. And welcome to the second quarter 2007 GTx earnings conference call. My name is Carol and I will be your coordinator for today.

(OPERATOR INSTRUCTIONS)

I would now like to turn the call over to McDavid Stilwell, Director of Corporate Communications. Please proceed, sir.

Thank you, and good morning. On behalf of GTx, I'd like to welcome you to our second quarter 2007 conference call. We released our results earlier this morning through the news wires. If you do not have a copy of the release and want one, you'll find it on our website at gtxinc.com. We'll have a replay of this call available on our website until August 14, 2007.

With me today are Dr. Mitchell Steiner, Vice-Chairman and Chief Executive Officer; Marc Hanover, President and Chief Operating Officer; Mark Mosteller, Chief Financial Officer; and Dr. Ronald Morton, Jr., Chief Medical Officer.

Following this introduction, Dr. Steiner will highlight second quarter 2007 clinical and corporate developments. Next, Mr. Hanover will briefly detail our financial performance. Dr. Steiner will then make a few closing remarks and 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 statements are subject to the risks and uncertainties we discuss in detail in our reports filed with the Securities and Exchange Commission including in our quarterly report on Form 10-Q filed May 7, 2007. 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. Good morning, and thank you for joining us for our second quarter 2007 conference call. This is an exciting time for GTx. We're approaching the completion of the Phase III ACAPODENE ADT clinical trial and the interim efficacy analysis of the Phase III ACAPODENE high grade PIN clinical trial. Success in either one of these two trials could transform our Company.

We're also pleased with the advancement of our first in class SARM Ostarine. The Phase IIb Ostarine clinical trial for the treatment of cancer cachexia was recently initiated. And a second Phase IIb Ostarine clinical trial for the treatment of muscle wasting associated with chronic kidney disease, or CKD, is on track to commence by year-end.

The Phase III ADT clinical trial is a two-year study, evaluating placebo versus ACAPODENE 80 milligrams for the treatment of multiple serious side effects of androgen deprivation therapy for prostate cancer. The primary endpoint is reduction in morphometric vertebral fractures. The secondary endpoints include changes in other measures of ADT side effects such as BMD, hot flashes, profiles, and gynecomastia.

The last patient will complete the Phase III ACAPODENE ADT clinical trial in late November. Once the final radiographic clinical and laboratory assessments have been completed, GTx will work expeditiously with the independent data management company to scrub and lock down the database that will be used to populate the data tables.

We project that the top line results of the ADT clinical trial will be available during the first quarter of 2008. The Phase III clinical trial evaluating ACAPODENE 20 milligrams for the prevention of prostate cancer in men with high grade PIN is a two-arm study, evaluating placebo versus ACAPODENE 20 milligrams in approximately 1,600 patients.

The primary endpoint of this clinical trial is a reduction in the incidents of prostate cancer. The timing of the interim efficacy analysis is predetermined by the actual number of aggregate prostate cancer events. If this interim analysis meets the pre-specified level of significance, GTx will proceed with filing a new drug application with the FDA.

Based on what we know today, we currently expect to conduct the interim efficacy analysis during the first quarter of 2008. We cannot project, however, whether it will occur before, along with, or after the release of top line results of the ADT clinical trial. We will update our projected timing of the interim efficacy analysis during our third quarter conference call in November.

Earlier this month, an independent Data Safety Monitoring Board conducted a planned semi-annual review of the unblinded data from approximately 3,000 patients participating in the two Phase III ACAPODENE clinical trials, and recommended that the two clinical trials should continue as planned.

The safety data from the two large ACAPODENE clinical trials supplement the already extensive safety database containing more than 355,000 patient years of experience with toremifene citrate 60 milligrams, which is the dose of toremifene that has been approved for the treatment of advanced breast cancer as Fareston.

The favorable safety record from the over 17-year market history for toremifene will be a critical component for the NDA applications for ACAPODENE, which we are making plans to submit in 2008. GTx has also recently conducted market research, which supports ACAPODENE for the treatment of side effects of androgen deprivation therapy and for the prevention of prostate cancer in men who have high grade PIN.

Each market survey polled more than 100 urologists who specialized in prostate cancer. For ADT the urologist survey said that the number one attribute they would desire is the ability to treat multiple side effects of ADT, not just a single side effect of ADT. According to this study, an oral drug like ACAPODENE 80-milligram, which may be able to potentially treat multiple side effects of ADT, not just osteoporosis, appeared to fill this unmet need.

The high grade PIN, the majority of surveyed urologists reasoned that based on their clinical experience, men with high grade PIN on prostate biopsy have a 34% likelihood of developing prostate cancer within three years. And that was three times greater than what was found if you had a normal prostate biopsy.

The majority of respondents also said they would prescribe a drug that demonstrates the ability to prevent prostate cancer in high-risk men who have high grade PIN. The prostate cancer prevention and high grade PIN medical literature continues to expand with several important new contributions within the last six months I'd like to highlight.

Dr. Gary Kelloff and Dr. Caroline Sigman of the NIH/NCI published an article in the July 2007 volume of Nature Reviews Cancer, describing the value of intraepithelial neoplasia as a target in cancer prevention drug development.

In a July 2007 article published in the Journal of Urology, this is interesting; Dr. Ian Thompson and his colleagues reported that high grade PIN was reduced in finasteride treated patients in the prostate cancer prevention trials, and suggested that the drug effects on high grade PIN may explain the reduction in prostate cancer served in the trial.

Dr. Stuart Ellem and Dr. Gail Risbridger of Monash University from Clayton, Victoria, Australia, have published an article in the August 2007 volume Nature Reviews Cancer, reviewing the scientific evidence supporting the role of estrogen to prostate carcinogenesis and the potential of [SERM] like toremifene to prevent prostate cancer by selectively blocking estrogen receptor alpha action in the prostate.

We're also pleased with the progress we're making in the clinical development of Ostarine. Following the demonstration of favorable efficacy and safety data from the proof of concept Phase II Ostarine clinical trial completed earlier this year, and after having conducted multiple meetings with the FDA to gain a better understanding of the regulatory pathways of the potential indications under consideration, we selected cancer cachexia and chronic kidney disease muscle wasting as the best initial indications for the clinical development of Ostarine.

We have recently initiated a Phase IIb Ostarine clinical trial for the treatment of cancer cachexia. Cancer cachexia is a debilitating, progressive muscle wasting condition marked by unintentional weight loss, muscle weakness, anemia, fatigue, and some cases death. More than 50% of cancer patients present with or subsequently develop cachexia.

Cases with advanced cancer who suffer from cachexia may respond poorly to or not able to undergo chemotherapy and radiation therapy. Cancer cachexia is associated with a poor prognosis and can adversely affect a patient's quality of life. There are no drugs approved by the FDA for the treatment of cancer cachexia.

The Phase IIb Ostarine cancer cachexia clinical trial is a randomized double-blind placebo-controlled study in 150 patients with non-small cell lung cancer, colorectal cancer, or non-Hodgkin's lymphoma and is being conducted at approximately 35 clinical sites in the United States and Argentina.

Study participants are being randomized to receive placebo, Ostarine one milligram or Ostarine three milligrams for four months. The primary endpoint of the trials change and total lean body mass or muscle at 16 weeks as measured by depths of body compositions scan. Secondary endpoints include functional performance and safety. GTx anticipates reporting top line results for this trial during the summer of 2008.

The second indication for clinical development of Ostarine is chronic kidney disease muscle wasting. Approximately 8 million Americans are diagnosed with Stage III or IV chronic kidney disease, and more than 500,000 with Stage V chronic kidney disease, also known as end stage renal disease.

Stage III and IV CKD patients experience muscle loss and weakness and consequently are three times the risk of becoming frail as age match controls. Another medical condition, which is highly prevalent among CKD patients, is insulin resistance and diabetes. A large number of patients who have CKD are diabetic and most of the rest are pre-diabetic.

And during the second quarter, GTx announced that an analysis of insulin resistance data from the Phase II Ostarine proof of concept clinical trial showed that Ostarine significantly decreased fasting blood glucose, increased insulin, and reduced insulin resistance.

Although diabetic subjects were excluded from that trial, in a small subset of pre-diabetic patients, the effects of Ostarine on insulin resistance compared favorably to similar data we gathered on several oral hypoglycemic agents currently approved to treat diabetes.

GTx is planning to initiate a Phase IIb clinical trial for chronic kidney disease muscle wasting in the fourth quarter. We believe that the CKD muscle wasting market represents an attractive commercial opportunity and there's an unmet medical need with no FDA approved treatments.

Earlier this quarter, GTx announced the hiring of two key senior executives. Dr. Ronald A. Morton, Jr. joined us Chief Medical Officer. Dr. Morton came from the University of Medicine and Dentistry at New Jersey Robert Wood Johnson Medical School, where he served as Professor of Surgery, Chief of Urology, Director of Urologic Oncology for the Cancer Institute of New Jersey, and Director of the New Jersey Center for Translational Sciences.

Prior to joining Robert Wood Johnson Medical School in 2004, Ron held a faculty appointment at the Baylor College of Medicine in Houston and was Clinical Director of Baylor Adult Urology Program, Chief of Urology at Houston Veterans Administration Medical Center, and the Director of the Baylor Prostate Cancer Center Research Laboratories.

He received his bachelor and medical degrees from the Johns Hopkins University, and completed his urology training and postdoctoral fellowship at the Johns Hopkins Hospital. Dr. Morton will provide outstanding relevant medical leadership for GTx. We also announced that Jeff Hesselberg has joined GTx as Vice President of Regulatory Affairs.

Jeff has over 19 years of experience in the biopharmaceutical industry, including 13 years in regulatory affairs. Most recently, Jeff was Director of Regulatory Affairs for ICOS Corporation, where he worked on the successful development, launch and commercialization of Cialis for the treatment of erectile dysfunction.

Jeff brings strong regulatory expertise and leadership at a critical time for GTx as we prepare for the potential filings of new drug applications for ACAPODENE, and as we advance Ostarine into late stage clinical trials.

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

Good morning. The details of our financial results for the second quarter 2007 are included in this morning's press release and are available on our website. I will focus on the highlights. The net loss for the quarter was $9.2 million, compared with a net loss of $10 million in the second quarter of 2006.

Revenue for the second quarter of 2007 was $1.8 million, compared to $623,000 for the same period last year. Revenue for the second quarter of 2007 included $360,000 of net sales of Fareston and $1.5 million of collaboration revenue from our European partner, Ipsen.

Research and development expenses were $8.6 million, and general and administrative expenses were $3.6 million for the three months ended June 30, 2007, compared with $8.4 million and $2.7 million for the second quarter of 2006. At June 30, GTx had $102 million in cash and cash equivalents. GTx has no debt and no warrants.

We also announced today that we lowered our guidance for our net loss for the full year 2007 to $46 million, from our previously announced guidance of $45 million to $55 million. This change is primarily a result of the timing of the occurrence of research and development activities and the related expenses across our portfolio of product candidates.

As we have mentioned before, our current cash is sufficient to fund operations through the first quarter of 2009. This timeline does not take into account the possibility of receiving milestone payments from our partner, Ipsen, an Asian partnership for ACAPODENE, or a partnership for our SARM [program]. If we receive cash from one or more of these three opportunities, we should be able to extend our cash runway beyond what we currently anticipate.

I will now turn the call back to Mitch.

Thank you, Marc. I would like to briefly highlight the superb efforts of our preclinical research and development team. This program is led by Dr. Jim Dalton, our Vice President of Preclinical R&D. Jim and Dr. Duane Miller, our Director of Medicinal Chemistry, were the first to report on a SARM in 1998.

During our ten-year life as a biotech company, we have established a very strong scientific reputation for our work discovering, developing, and applying novel selected nuclear hormone nonsteroidal small molecules to medical therapy. The fruits of these efforts have resulted in our ACAPODENE and our SARM programs.

Dr. Dalton has built a fantastic team of more than 35 scientists who have come to GTx from top pharmaceutical companies and universities. During the second quarter we introduced two new small molecules for clinical development. The first is GTx-838, another one of our SARMs, which we're developing for sarcopenia.

Sarcopenia is a condition of severe muscle loss that occurs with aging and other chronic diseases that leads to frailty, loss of independence, and death. The patent life on GTx-838 extends until 2027, which is six years longer than Ostarine. We expect to file the IND for GTx-838 by December 2007.

The second molecule is GTx-878. This is a novel ER beta agonist small molecule for benign prostatic hyperplasia and chronic prostatitis. In preclincial models, GTx-878 is anti-prostatic, anti-inflammatory, and also decreases smooth muscle tone. BPH is a large market opportunity. And with this possible triple mechanism, GTx-878 could represent a breakthrough new class of BPH drugs. We expect to file an IND for GTx-878 in 2008.

As we have stated previously there is substantial interest from multiple large pharmaceutical and biotech companies in our SARM program. We continue to evaluate when and whether to partner our SARM program. We will only do so if it is the right partner, and if we are successful in agreeing upon terms that recognize GTx's core competency in this area with a high level of participation and appropriate financial incentives.

With ACAPODENE for the treatment of multiple side effects of ADT, ACAPODENE for the prevention of prostate cancer, Ostarine for the treatment of cancer cachexia, and Ostarine for the treatment of chronic kidney disease muscle wasting, GTx is positioning itself to file multiple NDAs over the next several years.

Operator, we are ready to take questions.

Thank you, sir.

(OPERATOR INSTRUCTIONS)

Your first question comes from the line of Joel Sendek from Lazard Capital. Please proceed.

Hi, thanks a lot. I was hoping that you could give us some update on what the relationship or the dialog has been between you and the FDA recently. And the reason I'm asking is a lot of companies have had issues with their SPAs and the FDA holding up their end of the bargain.

And specifically in the ADT trial, I'm wondering, let's say you don't hit exactly what they want. For example let's say you don't get a 40% reduction in fracture rate, but you get a statistical significant result. Have you contemplated with them at all what that would mean? And maybe if you haven't, if you could just comment a little bit on that. Thanks.

Sure. Thank you, Joel. Let me answer it this way. As you know, we have an SPA for both our programs, for ADT and also for PIN. But to focus primarily on your discussion -- your comments around the discussions we had with the FDA on ADT.

Let's just take a step back, and as you know ADT is endocrine induced bone loss. And the osteoporosis guidelines -- guidance is clearly out there. What we chose to do was to take it one step further. And that is to have a discussion with the FDA specifically about our trial so that we can focus primarily around what is needed under an SPA.

So the SPA is pretty specific. Most of the time in SPAs, the issue is around the endpoint. In our situation the endpoint that we chose was the same endpoint that all osteoporosis trials have been approved on. And that is on morphometric vertebral fractures. So there's not much discussion there.

What you alluded to was the 40% reduction and the statistical significance that was discussed in the SPA. The SPA does not contemplate what happens if we don't hit the SPAs endpoint. And remember, the SPA is just what they lay out and you either hit it or you don't.

If you hit, everybody knows what happens. If you don't, we do have the advantage that there is written guidance out there in this space that we can go back and have a further discussion with the FDA based on precedent. As opposed to my gosh, this is so new no one knows where to go with this and no precedent's been set.

So we're very fortunate and we have the wide range of discussions that we can have with the FDA in the event the SPA is not fulfilled exactly.

Okay, that's very helpful. And then just a follow-up. In the event that you do hit it, in a best-case scenario, how soon can you get the filing in? Or, will you wait for both studies?

Yes. So the question is -- make sure I understand the question. The question is if ADT hits, and then would we wait to file the NDA until we see the PIN data? Is that the question?

Right.

Yes. So they're kind of independent in several ways. One they're independent and they're dependent. Let me tell you where they're independent. They're independent in the sense they go to different divisions of the FDA. So ADT is going to metabolic, and PIN is going to oncology.

The outcomes of these trials are being -- are run independently with different kinds of endpoints, different data management bases, databases. So they're really kind of two independent trials. So they're independent. And when they happen and how they occur is just dependent on for example ADT, last patient out, closing down the database, and getting the data back. And for PIN, hitting the prerequisite number of events, and hitting statistical significance.

Where they're dependent and actually helps us, is there are many modules that the NDA, because it's the same chemical entity, the same API, that we can use in common. So there is an effort at GTx as we speak now to populate those modules because we own the NDA for Fareston. So we're not waiting. We're doing that work now.

But the fact that these molecules are the same will provide efficiencies, not only in costs but also in time as we go forward and file the NDA. So really I don't think GTx will be in any position to make a decision to not look at data just because you've got data in hand. You want to see the other one.

So the timing of the data will -- and the top line data that we will announce will be determined by the individual trial, not how the trials relate to each other.

And assuming one of them comes in positive and you can move forward, or at least one of them comes in positive and you can move forward with the filing, and you get the data in the first quarter. Do you think with the new expertise on hand that you hired that you can get a filing in by the middle of next year? Or, is too early to tell?

We started the process almost a year ago. And we're trying to bring in the right people and the right outside groups to help us. So we feel that at least on the timeline that if either one of those are positive then an NDA will go in in 2008.

And then shortly right after that, we'll be putting in the second NDA. So if PIN comes first, then that one will go first. And if ADT comes first, that will go first. And -- but we'll be basically kind of working on both of them because again, like I mentioned before, there's some modules that are in common.

Okay, thanks a lot.

Your next question comes from the line of Meg Malloy with Goldman Sachs. Please proceed.

Thanks very much. I guess a couple of questions, if I might. The first is how -- I realize it's event driven, but what would you say the probability is at this point, given what you know that the data from PIN, the first interim analysis does occur in Q1 '08? And the flip side, what could push it out further? If you could just kind give us a little bit more of why you're confident there.

And then secondly could you elaborate, Mitch, a little bit more in terms of how you're thinking about partnerships? Do you think it's pretty high likelihood that you would wait for the summer data expected next year on Ostarine before you would do a partnership? And if not, what would cause you to do it earlier? Thanks.

Great. Thank you, Meg. Your first question is how confident are we in the projection that we'll see the interim analysis for PIN in first quarter '08? What's wonderful about this study is the fact that we can project out based -- let's say it a different way. The more data that we have in terms of patients that have developed prostate cancer, the better we're going to be of projecting when we're going to hit the pre-specified number of events.

That's why, for example, in November I'm going to be able to tell you even better what's going to happen in terms of timing. I will tell you that what appears now looks pretty good. That we're looking at a first quarter event for PIN. In fact, the things that would -- push it out would be if you don't have enough events. But we're not seeing that. So I think that the first quarter of '08 is going to be a realistic projection for PIN.

The question really is, is it at the beginning of the first quarter, the end of the first quarter, is it the middle of the first quarter? We'll know more about that in November. As for the partnership, we really want to make sure that we get as much shareholder value for the SARM program as possible. The interest that we're getting in the SARM program is predicated in part on the success that we had in our Phase II proof of concept.

And the Phase II proof of concept that was done in 120 patients in both males and females has provided a tremendous amount of clinical data that large pharmaceutical companies and biotech companies can make a decision. So I don't really think that we have to wait to the end of a Phase IIb to get the same enthusiasm that we're seeing right now.

With that said, we are seeing terms that are equivalent to a Phase III deal. And we are really -- because of the options that we have out there with so many pharmaceutical companies looking at this as potential partnership, it's giving us really an ability to be a little choosy. We want to choose -- and be choosy in a sense it's got to be the right partner, and we've got to have a strong participation.

And the financial terms have to be such that it really drives home shareholder value. And so at this point now, I'm feeling pretty good that we're heading in that direction. With that said, I do not think that we're going to have to wait for the Phase IIb data next year to see a partnership if the partnership makes sense.

Your next question comes from the line of Eric Schmidt with Cowen & Co. Please proceed.

Good morning. My question is on the interim Phase III data from the PIN study. Mitch, could you just outline for us under what circumstances investors would learn of the interim results? And under also what circumstances we would hear essentially nothing come Q1 '08?

Okay. So make sure I understand the question, Eric. So are you suggesting that GTx may do an interim and not see what they want to see and not mention it to the Street?

Well I assume you're going to tell us that the interim has taken place and that the study either proceeds or concludes.

Right.

So I guess I was asking for the stopping criteria more for the study.

Okay, so there's really no stopping criteria. So in other words, one result wouldn't be that GTx does an interim efficacy analysis. And the DSMB stops trial. Okay, that's won't happen, because it is a three-year study.

What could happen is just as you suggest in that is we do the interim analysis, we'll announce as soon as we have clarity on the interim analysis [what's] being told to us by the Data Safety Monitoring Board. And the Data Safety Monitoring Board comes back and says continue the trial as planned, then we will announce that.

The other way -- the other thing that we could announce is that GTx hits pre-specified levels, statistical significance. This is the reduction that we saw, and then in which case GTx will move quickly to file the NDA. So that's -- those are the scenarios.

Just those two.

Just those two. I don't think a scenario would be GTx stops trial.

Okay, and then --

Let me tell you why. Because the only reason you would stop the trial would be for safety reasons, and -- or you're not seeing the number of events that you want to see going forward. The events thing is off the table. We're seeing the number of events. So the only thing is safety. And we review this every six months.

And we just recently reviewed it. And toremifene 20 milligrams continues to perform very nicely from a safety standpoint. So that -- and I think the trial has been going on for about a year now. So I think that would be very unlikely that would be an issue.

Great. So maybe just to probe a little bit further. We know what the statistical criteria for this study are in terms of a positive result at the end of the study. Are there different statistical criteria, or maybe you could tell us, what the statistical criteria are for an interim halt after two years of data?

Right. So the total output for the trial is basically 0.01. And the FDA really didn't give us any room on that. As you know, the FDA under PDUFA requires two trials at 0.05 or one single trial at 0.01. If we do an interim analysis you have spend some alpha, but you also have to pre-specify what is the level of significance you need to hit in order to say that you hit an efficacy for moving forward.

In our situation, we needed to hit a P value of 0.001. We have an 89% power to hit that. And that means that at the end of the study we will have left 0.009, so 0.009. And -- which means that your level of significance will be roughly nine times more lenient if you don't hit in your interim.

So the real question becomes if you hit in your interim do you get to look at it again, or do you just ride it out to the end of the study? I think GTx is inclined at this point that if we don't hit at the interim to not do a second look until the end of the study when you have all the data. But at this point now, as I said, we have a 30% reduction, 89% power, we're going to hit at P value of 0.001.

At the interim you're saying?

At the interim.

Okay, so it's as simple as that. We'll hear something at the interim if the P value is less than 0.001.

That's right, so if the P value is equal or less than 0.001 you will hear about that.

Great. Thanks a lot.

Thank you, Eric.

(OPERATOR INSTRUCTIONS)

Your next question comes from the line of Howard Liang with Leerink Swann. Please proceed.

Thanks very much. So, Mitch, for the Ostarine Phase IIb trial included I guess either three or four tumor types, non-small cell lung, colorectal, and non-Hodgkin's. Can you talk about the why these tumor types were chosen?

Also what stage are these patients, whether they're metastatic or premetastatic? And what stratification is there in the trial?

Yes, I'd be happy to. So the first question has to do with cancer cachexia trial. One is the tumor type. Next question is basically what stage. And I'll tell you a little bit more about that.

So here's the concept. The concept was that we wanted to as much as possible recreate what we did successfully in our Phase II proof of concept clinical trial in which we included patients that if who were men they were greater than 60 years of age. And if they were women they were postmenopausal, which turns out on average is about the same age as the men, that were greater than 60 years of age.

So the next step is to pick a tumor type that the patient will have a life expectancy that we could see an increase in lean body mass and performance, and that the disease doesn't progress so quickly that the drug, you're not going to see efficacy with your drug.

Initially as you recall, Howard, we said that we were going to do a non-small cell lung cancer trial only as the only tumor type. But as you noticed, we've expanded it to colorectal cancer and non-Hodgkin's lymphoma.

The reason we did that, is after we did our site selection and after we looked at the number of potential patients, and after we looked at the timelines that we have set for GTx, which is to get enrollment done, to have data by summer of 2008. It became clear that a single tumor type wasn't going to be enough, especially given the amount of competition out there for clinical trials in non-small cell lung cancer.

So we went back and looked at colorectal cancer, which is about the same size as lung cancer, slightly -- the third leader. And then we looked at non-Hodgkin's lymphoma. It was a nice way to bolster the potential number of patients that we could select. So that's why we added the other tumor types; just to secure our ability to meet enrollment and to have data as we have stated.

The stage of the tumor type is just like we did in non-small cell lung cancer. And that is it's very early stage. We don't want to get patients that have had significant metastatic disease and significant weight loss, so that you're now dealing with a very sick patient population with numerous comorbidities that are independent of the weight loss.

So our thought was focus on patients who are newly diagnosed, with minimal comorbidities, with ECOG scores of zero and one. And really can be able to have the life expectancy that we can show the benefit of our drug.

Are patients being stratified by tumor type? And also, is CLL still one of the tumor types?

Yes. Make sure I understand the question. First question, are we going to stratify the data by tumor type? The answer is yes. We're going to do both. We're going to look at it in aggregate. And we're going to stratify it by tumor type. And the randomization is being done so that we can make sure that we have equal balance in terms of the tumor types per arm. The second question has to do with -- what was the second question? I'm sorry.

CLL.

Yes, the CLL. CLL, as you know a chronic lymphocytic leukemia can be put into one of two buckets. You can put -- in the leukemia bucket. It can be put in the lymphoma bucket. We decided to put it into the non-Hodgkin's lymphoma bucket. So CLL counts.

Okay, great. And is -- I want to ask you a question about preclinical SARM 838. How is it different from Ostarine?

838 is different from Ostarine in that it probably has a little bit more selectivity in prostate. But it's pretty similar to Ostarine otherwise. One of the reasons we picked it is because Ostarine has performed so well that to have a second molecule that we could potentially use in other indications and keep Ostarine moving would be great.

The other reason we picked 838 is the fact that the patent life is about six times longer. Excuse me, six years longer -- six years longer. And that doesn't take into account the five years that you would get half for development and half for review. And so what it allows us to do, for example, is we've decided to take 838 into sarcopenia.

As you know, sarcopenia would be larger trials that require longer time. At least we learned from Ostarine what we need to do to position 838 and to move it into a much larger indication, and perhaps keep Ostarine for the more premium indications.

So that's completely up in the air based on data. So if a year from now we look at 838 data and we look at Ostarine data, and anything suggests one should be one way and one should be the other way, we have that luxury to make that decision. So we felt that we should have human data on at least SARMs going forward to help us best choose which indications to put them in.

Are these two compounds in the same chemical class?

They're not the same chemical class. They're different chemical series.

Okay. If I could ask one more question on the timeline for ADT trial. It seems like that more recently you dropped the possibility to having data in the fourth quarter. Is that just -- is there any -- is that a real change or is that you're being more conservative in your estimate?

You're talking about ADT?

Yes, ADT.

Yes, so fourth quarter -- what we know now is that the last patient's out November 20. It's not that we're being conservative we're being realistic that you've got to -- that's just the beginning.

Now what happens is all the stuff in the back room. And that is they've got to make sure that they answer all the questions that are outstanding. They've got to clean up the database. They've got to populate the tables. And that's the independent CROs.

So when we go to them and we tell them look last patient is out November 20, when can you get us the tables? There's no way they physically can get us the tables in December. So it's got to be somewhere in first quarter.

Great. Thanks very much.

Thank you, Howard.

Your next question, sir, is a follow-up question from the line of Meg Malloy. Please proceed, ma'am.

Thanks very much. Just a quick housekeeping item for Marc, and that is can you break out the ESO expense and how it's allocated to SG&A and R&D, please?

Sure. On the -- you're referring to the FASB 123R, Meg?

Yes, exactly.

Our year-to-date -- through the year-to-date second quarter our amount charged to R&D was $426,000. And the amount charged to G&A was $524,000. On a quarterly basis, on the second quarter we had $193,000 charged to R&D and $250,000 charged to G&A.

On a per share basis, on a quarterly basis, the amount of R&D per share was 0.006. The amount on G&A per share was 0.007. Combining the two you get 0.013. On a year-to-date, the R&D per share was 0.012. And the amount on G&A per share was 0.015. If you combine them, it's 0.027.

Thank you. That's more detail than I was expecting. And the guidance that you're giving this year includes option expense. Is that correct?

That's correct.

Thank you.

Thank you, Meg.

There are no additional questions in queue. I would now like to turn the call back over to Dr. Steiner for 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.

Thank you for joining in today's conference. You may now disconnect and good day.