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GTx, Inc. (NASDAQ:GTXI)

Q4 2012 Earnings Call

February 21, 2013 9:00 AM ET

Executives

Mitchell Steiner – Vice Chairman and CEO

Marc Hanover – President and COO

Analysts

Eric Schmidt – Cowen & Company

Biren Amin – Jefferies

Ryan Martins – Lazard Capital Markets

Mike King – JMP Securities

Howard Liang – Leerink Swann

Operator

Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2012 GTx Earnings Conference Call. My name is Carissa and I will be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the conference over to your host for today’s call, Dr. Mitchell Steiner, CEO of GTx. Please proceed.

Mitchell Steiner

Thank you, operator. I will be making forward-looking comments during today’s call and I direct you to the press release of our financial results we filed today and the quarterly report on Form 10-Q we filed November 8, 2012 with the SEC where we discuss the risks and uncertainties that affect our business.

I will begin with an update of our clinical programs starting with enobosarm for the prevention and treatment of muscle wasting in patients who have advanced non-small cell lung cancer. As we’ve previously announced last quarter, we have completed enrollment of our two Phase III clinical studies of enobosarm, POWER 1 and POWER 2. We have enrolled into each clinical study approximately 325 subjects, who have either Stage III or Stage IV non-small cell lung cancer in over 80 clinical sites located in the United States, Europe, Russia, and South America.

The objective of these studies is to determine the potential of 3 milligrams of enobosarm versus placebo to prevent and treat muscle wasting in advanced non-small cell lung cancer patients. When given at the same time, they initiate standard first line chemotherapy consisting of a platinum doublet. More specifically, in POWER 1, subjects are receiving a platinum, which is cisplatin or carboplatin plus a taxane, docetaxel or paclitaxel. And in POWER 2, subjects are receiving a platinum plus a non-taxane, gemcitabine, vinorelbine or pemetrexed.

Unlike Megace and other drugs, which are currently used to increase appetite and have detrimental effects on muscle mass in cancer patients with cachexia, with enobosarm, in this indication, clinical benefit is defined as maintaining or improving total lean body mass or muscle assessed by DEXA and improving physical function assessed by the Stair Climb Test at day-84. The co-primary endpoints for each of these studies consist of a responder analysis of clinical benefit. Durability of the drug is being evaluated as a secondary endpoint at five months of treatment in those patients who are determined to have responded at day-84. This is not an appetite drug.

The agent is being evaluated to prevent or treat muscle wasting, a common and devastating cancer-related symptom for which there are no – there are currently no medical treatment. With the last patient being enrolled at the end of December 2012, we expect all subjects to complete the two studies by the end of May 2013. And after taking into account the time required to finalize all patient documentation for both studies at sites in eight countries in order to prepare for data lock, which at this time is still somewhat dynamic.

We currently anticipate that we will receive top-line data from these studies in the third quarter of this year. We intend to share the top-line data for both studies, POWER 1 and POWER 2, at the same time. The top-line data at a minimum will include the co-primary endpoints of lean body mass and physical function and safety, as well as an update on the survival information at that time.

In January of this year, we announced that FDA has designated enobosarm for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer as a Fast Track development program. The IND for enobosarm is in the oncology division, and this action is consistent with my previous points on the seriousness of muscle wasting as a cancer-related symptom.

Fast Track status is a process designed by FDA to facilitate the development and expedite the review of new drug candidates that are intended to treat serious diseases and have the potential to fill an unmet medical need. With a Fast Track designation, there is an increased possibility for a priority review of a new drug application we filed for enobosarm and more opportunity for us to have frequent interactions with FDA both prior to and following the filing of the NDA. The FDA clearly recognizes muscle wasting in these cancer patients as a serious and unmet medical need.

The oncology field is also changing. Clinicians are now finding in their treatment of cancer patients as addressing patient’s symptoms and quality of life can result in better clinical outcomes from the underlying cancer treatment. Over the past several years, we have seen the development of new cytotoxic chemotherapies to treat advanced non-small cell lung cancer. However, these chemotherapy agents have offered little or no survival advantages over standard therapy.

If these new therapies cannot make meaningful improvements in survival for non-small cell lung cancer patients when treating their tumor, we believe enobosarm by treating the host, the patient, can at least improve their quality of life, such as physical function, while they fight their cancer and potentially better equip them to tolerate the chemotherapy treatments for longer periods of time and delay their need for specialized nursing services and hospice care.

The American Society of Clinical Oncology, or ASCO, recently published a provisional clinical opinion regarding the need to integrate palliative care early into standard oncology care in patients with non-small cell lung cancer. Early palliative care for the treatment of lung cancer patients is recognized as a critical component of effective cancer comprehensive care. Patient issues and concerns such as quality of life, muscle wasting resulting in a decline in physical function, fatigue, loss of independence, and increased healthcare services utilization are important aspects in the care of patients undergoing cancer treatment.

GTx has designed its POWER 1 and POWER 2 Phase III clinical studies to assess many of the same outcomes suggested by ASCO as key endpoints in these studies, including quality of life, healthcare resource utilization, ability to receive planned chemotherapy, dose intensity, and overall survival.

We believe the treatment of muscle wasting in non-small cell lung cancer patients is an attractive market for enobosarm. Approximately 1.6 million people worldwide will be diagnosed of lung cancer this year, and the five-year survival rate for this diagnosis remains only approximately 15%, notwithstanding the introduction of many new cancer treatments. About 85% of all lung cancers of the non-small cell lung cancer type making this disease a leading cause of death for both men and women.

Our market research suggests that our peak US sales from enobosarm should be approximately $700 million – $750 million. And of course, this estimate does not take into account sales outside the United States and the potential for enobosarm to address muscle wasting in other disease states or to treat other indications. We’re already planning additional clinical studies for enobosarm to address indications where we believe there is a good opportunity to benefit patients and to expand the drug candidate’s commercial potential.

Now, to update you on Capesaris, also known as GTx-758, our other late-stage clinical program, where we are conducting fifth Phase II clinical study of Capesaris, an oral selective estrogen receptor alpha agonist developed by GTx scientists for the treatment of advanced prostate cancer. We believe Capesaris can offer unique treatment option for men with advanced prostate cancer by reducing free or the unbound testosterone levels lower than can be typically achieved by LHRH agents or surgical castration.

Capesaris accomplishes this by causing the liver to increase production of a protein called sex hormone binding globulin, or SHBG, which binds very tightly to the unbound or free testosterone circulating in the blood and further reduces the levels of serum-free testosterone in the castrate environment.

Treatment of prostate cancer with androgen deprivation therapy, or ADT, improves prostate cancer symptoms, but patients eventually develop castration-resistant prostate cancer as their cancer adapts and uses the available free testosterone in the blood to grow.

Dr. Evan Yu, Associate Professor of Medicine at the Fred Hutchinson Cancer Research Center in Seattle, Washington, presented last week four related abstracts at the 2013 ASCO Genitourinary Cancers Symposium in Orlando, Florida.

In two Phase II clinical studies in men with advanced prostate cancer, patients receiving either the 1,000-milligram or 2,000-milligram daily doses of GTx-758 demonstrated significant reductions in their serum-free testosterone levels with related increases in SHBG and reductions in their levels of serum PSA. One of the trials, 705, compared the effects of the 1,000 milligrams and 2,000 milligram doses of GTx-758 in newly-diagnosed advanced prostate cancer patients with a cohort of patients receiving leuprolide, an established primary androgen deprivation treatment.

The primary endpoint of the trial was the proportion of men who achieved medical castration by day-60. Though in hormone-naïve advanced prostate cancer patients in this study the lesser reductions in serum total testosterone observed in men receiving GTx-758 dosed by 28 days, there were larger decreases in serum-free testosterone observed in these same men as compared to leuprolide.

Reductions in serum PSA at 28 days appears to be more strongly associated with the observed changes in free testosterone rather than total testosterone with PSA reductions of 84%, 73% and 56% from baseline for subjects treated with 1,000 milligram and 2,000 milligram doses of GTx-758 and leuprolide, respectively.

In men treated with GTx-758, SHBG levels increased approximately 400% and were associated with decreases in serum-free testosterone and serum PSA. We have a presentation, stuff that you reviewed the data from our Phase II studies on the effects of GTx-758 and leuprolide, on the estrogen deficiency side effects with GTx-758 compared to leuprolide patients, had fewer hot flashes, had improvement in bone markers, and had less insulin resistance even in the background of having a lower free testosterone level.

In the current Phase II clinical trial 712, to evaluate the safety and effectiveness of lower doses of GTx-758 to treat men with metastatic castration-resistant prostate cancer, 75 men with metastatic castration-resistant prostate cancer are being randomized into one of three cohorts to receive a 125 milligram, a 250 milligram or a 500 milligram daily dose of GTx-758. Each arm will have 25 patients and the enrollment will be conducted sequentially with the 125 milligram cohort currently accruing patients.

Enrollment to the next higher dose of GTx-758 will commence at an acceptable incidence of VTEs is observed among randomized patients for 30 days following enrollment of the last patient in the previous cohort. The primary endpoint will be to lower serum PSA by greater than 50% – greater or equal to 50% by day-90, and other key endpoints include free and total testosterone, SHBG levels, and progression-free survival in these study subjects.

In addition, the study will evaluate the ability of GTx-758 to treat certain estrogen deficiency side effects associated with medical castration such as hot flashes, bone loss and insulin resistance. Enrollment for the study is progressing. We continue to add sites to the study, including sites outside the United States, and we anticipate we will have data from this open-label study sometime in this summer.

We believe the lower doses now being studied will be effective in substantially raising SHBG and thereby lowering free testosterone while minimizing concerns associated with VTEs seen in our studies of Capesaris at higher doses. This proves to be true, and GTx will assess the potential treatment options available to Capesaris, including using the drug product as a first secondary hormonal therapy or as a primary therapy used in combination with ADT in the treatment of advanced hormone-naïve prostate cancer.

This morning, we also released our financial results for the fourth quarter and full year of 2012. While I will not review the financial results in detail, let me point out that we reported $56.1 million in cash at the end of the year and we have no debt or warrants outstanding.

Marc Hanover and I will be happy to answer any questions you may have about our financial results during the Q&A.

Operator, we are now ready for our first question.

Question-and-Answer Session

Operator

(Operator Instructions) And your first question comes from the line of Eric Schmidt of Cowen & Company. Please proceed.

Eric Schmidt – Cowen & Company

Good morning, guys. Thanks for taking my questions. First on enobosarm, Mitch, you’ve mentioned or reiterated the primary endpoint of the studies are three months, but it sounds like, if I’ve followed you correctly, that you’re only going to unlock the data after the five months secondary endpoint. Is that the intention? And why wouldn’t you unlock the database just after the three-month primary endpoint?

Mitchell Steiner

Okay. So, to make sure I understand the question, so the question is the primary endpoint is going to be a day before three months and you’re going to continue to follow the patients for another two months to have five months on study. And the question you’re asking as well, if all the patients are done with the primary endpoint at month – day before, then why not just look at the data a day before? Is that the question?

Eric Schmidt – Cowen & Company

That’s right. Correct.

Mitchell Steiner

Okay. Well, the answer is, we’ve had a lot of discussions about this. So the FDA also takes very, very seriously a key secondary endpoint, which is durability. And so the concern would be that if you unlock the data at day-84 and present that data without – and the patients that are still on the study find out that we have positive results, then how is that going to affect the day-147 or the five-month data? And the protocol that we have written clearly says that the protocol is not over until the conduction – the conduct of the study is not over until the patients have crossed day-147. So it’s just – we’re just following the protocol. So it’s not really one reason or not. So that’s the reason why we have to wait for the last patient to come out in May.

Eric Schmidt – Cowen & Company

Okay. So, do you think you kind of need to see the durability as effective at five months? Do you need the five-month data to be positive as well as the three-month in order to file the drug?

Mitchell Steiner

Well, as you know – the answer is it doesn’t have to be positive, and I’ll tell you – let me say it different way. Because of the fact it’s a five-month endpoint and because of the fact that we’re not powered to show a positive effect at five months from the standpoint of durability, it’s purely descriptive. The FDA sees it as a key secondary endpoint. And so it’s not like you have to have “statistical significance”, but the FDA is interested in seeing what happens to those patients that respond at day-84. Do they continue to respond at month-five? So that’s really what it is as opposed to, oh, my gosh, now you got another endpoint you have to hit.

Eric Schmidt – Cowen & Company

Okay.

Mitchell Steiner

It’s descriptive in nature.

Eric Schmidt – Cowen & Company

So you might want to see a trend in other words?

Mitchell Steiner

That’s right, or at least – yes, or at least understand what the durability is. It’s not necessarily –

Eric Schmidt – Cowen & Company

Okay. And I think this is the first time you’ve given your peak US market expectation of $750 million. Could you talk about the details behind that assumption, maybe any kind of a pricing range that you’re thinking about and whether that peak projection assumes that you have disease modifying profile or impact on overall survival?

Mitchell Steiner

Yes. So let me see if I can summarize it. What we did is we hired an outside independent group to do the market research for us because one of the big issues we wanted to make sure that we understood – we wanted to make sure that we understood what the market would be, because folks like yourself and others have been saying, well, there are a lot of alternatives, we just don’t know what the marketplace is going to – you know, there’re other alternatives, will GTx be able to get their price? Will people use the drug? And quite frankly, we have a fiduciary responsibility to make sure that we understand what the market is, especially now that we’re in Phase III.

So we spent the money, got an independent market research both in US quantitative – qualitative in US, qualitative ex-US, and quantitative in US, which means they do even more extensive interviews with payers, with oncologists, with primary care physicians, and the – and what we ask them to do, Eric, is not to address the issue of overall survival, because most of our key opinion leaders are saying, if we can’t hit overall survival with our chemotoxic agents, how are we going to expect to see an improvement in survival with our agent that’s treating the host.

Now, they all believe we should see a trend, but that’s not the issue. The issue is when you’re trying to pick your target product profile, which is an agent that will improve physical function and maintain lean body mass in these patients that are being hit with first line chemotherapy, and the safety being a safe drug, which I can say at this point now everything points in the direction that there’s no surprises that we know of.

So, therefore, that was the product – target product profile that was put to the oncologists. The oncologists get it. There’s a big move now to treat muscle wasting and – at least have something to treat muscle wasting. If you talk to the typical oncologists, they will tell you that Megace will increase appetite but actually be a detriment to muscle. And so this is not a substitute or an alternative for a drug like this. And they were hoping that EPO would do this with fatigue by increasing red blood cells, but that’s not – I mean, this seems to be more related to the lack of muscle.

So when we did our market research, first thing we found out was that if this drug was available, most medical oncologists would use this drug. And on a scale of seven, the rating that we got was like 5.8 to 6.2. So it’s a highly rated drug that would be used, especially within NCCN guidelines, which would make sense it would be since this is a first-in-class compound.

Then the next question would be, well, remember now, all we’re going to do is maintain lean body mass and improve physical function and what would that be worth. And so, after going through the pricing of other cancer-related symptom-type drugs like Zometa, Xgeva, Neulasta, and things that you give the host, i.e., the patient, to make them feel stronger. The price range – lower end of the elasticity – in other words, I’m not going to go to the high-end because high-end is always great. The lower end was they felt that we could get $1,500 a month for the patient. And if you did $1,500 a month, plus on average, patients will be on drug for five months, and you take the number of lung cancer patients in the United States, which they independently confirmed was in the range of 170,000 patients a year, we end up with a peak of about $750 million in US alone. Payers did say they would pay for this with minimal pre-authorization and would be considered a – I believe market was at Tier 3. And then the other thing we know is that the payers also recognize that it could potentially be used in other cancer ties. Of course, we would never promote for that, but there is willingness to reimburse for that.

And we would do Phase IVs and make sure we – Phase IVs and additional Phase IIIs to make sure that we have the data there for – to expand our label in cancer. And that was – so we were very pleased with the quantitative and the qualitative data that we were able to go back to our board and tell them that in the US only, we would have $750 million in sales. They reviewed that. And again, that’s US-only only in non-small cell lung cancer. It doesn’t take into account ex-US or as we expand into other indications.

Eric Schmidt – Cowen & Company

Great. Those are very helpful details. One last question moving over to Capesaris –

Mitchell Steiner

Sure.

Eric Schmidt – Cowen & Company

Could you disclose the acceptable incidence of VTEs in the first 25 patient cohorts that would allow you to move on to the next cohort?

Mitchell Steiner

There’s really two – there’s two answers to that. The first one is, what do we think should be an acceptable VTE rate to go forward with the program, for getting going to the next cohort? And the answer is, we’re going to look for something less than 5%. But the stopping rules are more lenient than that. But if we want to go into early prostate cancer, which means hormone-naïve prostate cancer, we’ll be the first hormonal – secondary hormonal therapy, for example, in non-metastatic castrate resistant prostate cancer patients. Then we really – regardless – I mean, regardless of the stopping rules, we really need to see a VTE rate less than 5%.

Eric Schmidt – Cowen & Company

Okay. And the stopping rule is then how high?

Mitchell Steiner

It’s – it’s higher than that, but it’s – it doesn’t matter because we’re not going to go – we’re not going to move forward if we don’t have a product.

Eric Schmidt – Cowen & Company

Okay. So you would – even if you had a, I don’t know, 6% rate of VTEs, you would move forward?

Mitchell Steiner

Yes. I don’t – the number is higher than that, but we still wouldn’t move forward.

Eric Schmidt – Cowen & Company

Okay. Thank you.

Mitchell Steiner

Thank you.

Operator

And your next question comes from the line of Biren Amin of Jefferies. Please proceed.

Biren Amin – Jefferies

Yes, hi. Thanks for taking my questions. I wanted to ask you, Mitch, on the POWER 1, POWER 2 studies. I know you mentioned that you’re going to provide an update on overall survival when the study reads out. And since the overall program has, I think, about 450 events that you’ve built into the program, what are the number of OS events that you expect when the study does read out in Q3?

Mitchell Steiner

Okay. So, just to be clear, overall survival is a key secondary safety endpoint and we have agreement with FDA that we will pool the data from both the POWER 1 and POWER 2 studies in order to make an assessment. The assessment is, as I said, descriptive. And although we have – will provide in our SAP, statistical analyses in the event that survival trend is strong enough that we can hit statistical significance.

With that said, at the time we pull the trigger and look at our top-line data, we will not be at 450 events, as you mentioned. We’ll be somewhere in between, and consequently, what we will do is we will tell you the number of deaths in POWER 1 and we’ll tell you that number of deaths in POWER 2 so that at least you’ll have an understanding of what the deaths look like. And when I say deaths, it’s deaths in the treated, deaths in the placebo.

Right now, we’re tracking appropriately to see the number of deaths of 450 pretty darn close to the time that we filed the NDA. And also, as you know, we’ve given an additional 120 days for a safety update after we filed the NDA. So, at the time of the top-line data, and I’m just guessing at this point, we should be well beyond half the deaths at that point – half the expected deaths.

Biren Amin – Jefferies

And as part of your analysis, what do you expect on OS, is there any assumptions that you would – as far as how the OS would perform in the placebo group versus an active arm?

Mitchell Steiner

Well, the good news is we can go back – you mean, like a point estimate kind of thing?

Biren Amin – Jefferies

Right.

Mitchell Steiner

So, we can go back and look at the actual – it’s very interesting. We went back and looked at the actual overall survival rates in patients on first line chemotherapy. For all of the different chemotherapies that we’ve given, we can go back to the label and actually find the point estimates for these patients.

And the point estimates for these patients almost in every single one of these chemotherapy agents are about 0.8. so you have an 80% probability of survival certainly at the four to five-month time point. And so it gives you sort of a stake in the ground in terms of, you know, you don’t want your survival to be worse than chemo alone. But it also tells you that we come in better than that that that’s what chemo alone can do.

Biren Amin – Jefferies

Great. Thanks for taking my questions.

Mitchell Steiner

Sure.

Operator

And your next question comes from the line of David Nierengarten of Wedbush Securities. Please proceed.

Mitchell Steiner

David?

Operator

David, your line is open. You may proceed. Your next question will come from the line of Ryan Martins of Lazard Capital Markets. Please proceed.

Ryan Martins – Lazard Capital Markets

Hi, thanks. Mitch, I was wondering if you could maybe speak about how the activity of enobosarm could vary if at all when combined with the different non-taxanes in one of the Phase IIs.

Mitchell Steiner

Okay. So the question is, are there any potential drug-drug interactions with enobosarm, with taxanes or non-taxanes, quite frankly, even with the platinum? Is that the question?

Ryan Martins – Lazard Capital Markets

Yes, actually more on the lines of how the activity of enobosarm could vary depending on what the non-taxane is that’s used.

Mitchell Steiner

Yes. So our belief is it should not vary. We do not think we’ll have in effect on any of the chemotherapies that enobosarm is metabolized by glucuronidation. And so consequently, it’s – and the body has a huge capacity for glucuronidation. So we’re not expecting, whether it’s a taxane or a non-taxane or platinum, that we will have any appreciable drug-drug interactions of – we’re not concerned about that.

Ryan Martins – Lazard Capital Markets

Okay. And just to confirm, we will see the durability data at five months when you have your top-line press release?

Mitchell Steiner

No. I think what we’re going to be presenting is – at least at this point. That’s why if you’ve heard my prepared comments, I said at minimum because that’s what everybody wants to know. What will they see in their top line? And so at minimum, we’re going to do the primary – co-primary endpoints, the safety update or safety at top-line and then the deaths at that time, survival at that time, and of course, we’ll update the survival. And we just haven’t made a determination on durability. But just talking out loud, if we have it, there’s no reason why we can’t share it.

Ryan Martins – Lazard Capital Markets

Another one around the DSMB, (inaudible) meeting again before you get the top-line? Will we just get some update on the safety at that point too?

Mitchell Steiner

Yes. So the DSMB meets again in April. And so at that point after the DSMB meets, we’ll make a comment as to the outcome of that meeting.

Ryan Martins – Lazard Capital Markets

Perfect. And just on Capesaris finally, are we going to have data from all three cohorts when you report it in summer – in the summer or is it going to be a couple cohorts at that point?

Mitchell Steiner

It’s a good question. Since we’re doing dose escalation pretty much, it’ll be – we’ll give you data as we have it, and hopefully it’d be conclusive enough that you can understand where we’re going in the next steps. And so I’d rather leave it open because it’s open label and we’re assessing each one not only for safety but for – also for efficacy. And so if you’ve seen the efficacy that you need at lower doses, we made – we may elect not to go higher. And so it’s not like you have to fill the trial, get every cohort filled. That’s why it’s open label. So we’ll make some decisions along the way. We’re hoping by summer, we could make a decision.

Ryan Martins – Lazard Capital Markets

Okay. And have you said where you are in enrollment currently?

Marc Hanover

If – whether we said enrollment –

Mitchell Steiner

No, no, not really. I mean, we just feel like – not really. I mean, all we want to do is make sure by summer, we can make a conclusion.

Ryan Martins – Lazard Capital Markets

Okay. Thanks.

Operator

And your next question comes from the line of Mike King of JMP Securities. Please proceed.

Mike King – JMP Securities

Good morning, gentlemen. Thanks for taking my call. I had a question on enobosarm and a question on Capesaris. Just first on enobosarm, Mitch, I don’t know if you’d be willing to tell us, but I’m just wondering, can you speak to sort of proportionately the sites and their geographic location? In other words, you’re expecting 10%, 20% to be in the US, less or more, and how that’s playing out right now?

Mitchell Steiner

Yes. So the study is done and we have – we have – the majority of the sites are outside the US, as expected with clinical trials these days. What was more important to us than the actual location was making sure that we didn’t introduce geographic variability because of, like, for example, if we did – if we had sites in China and sites in India and sites in strange places where we did not have experience.

What we did is we took a different approach. Our Phase IIb was done in South America and US, and most of the patients have European descent and extraction. And so we focused primarily in making sure that we fill the trial with similar patients that we did in the Phase IIb, because if you do that, then you don’t get into the confounding problems of, like, for example, in India where patients may show up very, very late in a disease and consequently you’re dealing with a very advanced stage as opposed to what you see in US, Europe or in South America or Russia for that matter.

So that was more important to us and making sure that we balance the homogeneity, if you will, of the patients and their type of standard of care they would get and try to minimize that. We can always go into special populations later.

Mike King – JMP Securities

Okay. Yes, I’m just I think really more concerned with things like protocol adherence and (inaudible) enrollment.

Mitchell Steiner

Sorry, we – yes. No, we have – I will tell you that from a GCP standpoint, we’ve done our audits, it looks good. And on top of that, we have not had to – we have stuck very, very hard on our protocol. So, once the study is started, there were basically no additional amendments. I mean, I’m proud of that that we didn’t – sometimes studies have amendment after amendment. We did not. And then I personally visited sites all through Europe, almost all of them quite frankly in Europe, almost all of them in South America, certainly all of them in the US, and these are top sites.

Mike King – JMP Securities

Okay, great. Appreciate that. You’re working on your million mile club.

Mitchell Steiner

It’s actually more than that, but I’m embarrassed to say it, but yes.

Mike King – JMP Securities

Yes. And then on Capesaris, do you have the unblinded PSA and SHBG levels? And I don’t know if there’s any hints or suggestions that you might be able to provide us with that. The trends are what you expected as far as the overall data set is concerned.

Mitchell Steiner

Yes. So the question you’re asking is, are we getting any early indications that the doses that we’re testing is showing some activity?

Mike King – JMP Securities

Yes.

Mitchell Steiner

And I – and if you want a more complete review on that, we did mention that we had an – and you were on the call I believe. We had an analyst day – or an analyst hour at GU ASCO. And if you go to our website and look under GTx Analyst Day, you’ll be able to get more complete information not only on the study but also based on what three key opinion leaders think about our drug and how it fits in the field and some data by, for example, Dr. Evan Yu.

But for purposes of this call, yes, we are seeing very small numbers, but nonetheless when you’re dealing with blood levels, small numbers are pretty tight. And we are seeing substantial increases in SHBG reductions and three key reductions in PSA. But it’s still too early to say much more than that. So I’m excited because one of the concerns that was raised is that, yes, you can lower the dose by tenfold from your lowest other dose and twenty-fold –

Mike King – JMP Securities

Right.

Mitchell Steiner

– from the dose you did in 707, and we’re going to feel comfortable that you’re going to hit your safety but you’re not going to have your efficacy. Well, I’m comfortable now that we’re fine and we just have to prove it out.

Mike King – JMP Securities

Okay. I’ll get back in queue. Thank you.

Mitchell Steiner

Sure thing. Thank you.

Operator

And your next question comes from the line of Howard Liang of Leerink Swann. Please proceed.

Howard Liang – Leerink Swann

Yes, hi. Thanks very much. Just on the – for your enobosarm Phase III study, do you have an understanding of what FDA is looking for in overall survival data? Does it have to show a positive trend or does it have to – just not to show a inferior signal?

Mitchell Steiner

Yes. So it’s the inferior signal. So the FDA – the FDA’s made a -it’s funny because we had three face-to-face meetings with FDA and one of the – in the second meeting or maybe – yes, this is the first meeting actually, they said that the overall survival would be a key secondary endpoint – key secondary safety endpoint. So we didn’t know what that meant. So we went back and had a full statistical evaluation plan, and the FDA reviewed it and said, no, no, no, you don’t understand. You’re not going to have the power to show that kind of stuff. He said, all we care about is that the trend doesn’t go negative and it can be purely descriptive. So that’s all the FDA is looking for.

Howard Liang – Leerink Swann

Okay, great. Then just regarding the tests, the functional test for example, when are they performed? Are they performed periodically or only at three months or five months?

Mitchell Steiner

They’re being performed at – they’re being performed at baseline, day-42, day-84, day-147.

Howard Liang – Leerink Swann

Okay, great. Thank you very much.

Mitchell Steiner

Thank you.

Operator

And you have a follow-up question from the line of Mike King of JMP Securities. Please proceed.

Mike King – JMP Securities

Well, that was quick. I just wanted to ask the – a question about the requirement or the interest in durability for enobosarm, and I just – I guess I’m a little bit baffled by it because why would – why would that be important after drug cessation? It just seems like if you’re treating the patient with chemotherapy that could induce sarcopenia that you would keep the patient on the drug, you wouldn’t – there’s no incentive to take the drug away. So what’s the thought process there?

Mitchell Steiner

Yes. The thought process here is almost like the pulmonary artery hypertension drugs in which the FDAs, all they’re asking is, can we make some statement about what happens to a patient if they stay on drug. So the durability is, if you take the patients that responded at day-84, month-three, and now you go back and look at five months, how many of those patients continue to have the same durability? Not (inaudible) the same durability is, they have to show a 10% improvement in physical function and they have to maintain the lean body mass. It’s descriptive. It’s not statistical. So this is more in terms of just understanding what you could tell the patient. It’s not – this is not the primary endpoint.

Mike King – JMP Securities

No, I understand. I’m just – I’m going to – it seems like a – it’s a thought experiment, but it doesn’t seem like it’s got –

Mitchell Steiner

No, no. To me –

Mike King – JMP Securities

– the clinical relevance.

Mitchell Steiner

Right. That’s fair, because the clinical relevance is that you’re going to start the patient on the drug right when they start chemotherapy, right when they’re going to have the onslaught of the toxicity related to the drug and the toxicity related to the tumor. And since prevention and treatment, it’s not only treating the patients already in trouble but to prevent patients from getting into trouble. And those, by definition, are two different populations and they will be assessed with this.

And so – the way we look at it is that we’re going to get good information about what happens in patients that take our drug the entire time, not just the ones that respond to day – at day-84, because you could argue that if you have a patient at day-84 that didn’t respond as well as they need you to hit the responder’s analysis definition, but if they stay on the drug up to five months and now they start responding, well, that’s good information too.

Mike King – JMP Securities

I see. Okay. Great, Mitch. Thanks.

Mitchell Steiner

Thank you.

Operator

At this time, I’d like to turn the call back over to Dr. Steiner for closing remarks.

Mitchell Steiner

I would like to thank everybody for joining us on today’s call and I’d like to thank you all for your interest in GTx. I look forward to updating you on the progress of our studies in the future. Thank you.

Operator

Thank you very much. This concludes today’s conference. Thank you for your participation. You may now disconnect. Have a wonderful day.

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