Corcept Therapeutics Incorporated
Q1 2016 Earnings Call Transcript

Published: 4 May 2016

[Operator:]

Welcome to the Corcept Therapeutics Conference Call. My name is Anna and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. I will now turn the call over to Charlie Robb. Please go ahead.

[Charlie Robb:]

Thank you. Good afternoon. My name is Charlie Robb, Corcept’s Chief Financial Officer. Joining me today is Dr. Joseph Belanoff, our Chief Executive Officer. Thank you all for participating in the call. Earlier today we issued a news release giving our first quarter 2016 financial results, a reaffirmation of our 2016 revenue guidance and the corporate update. To get a copy of this release, go to corcept.com and click on the Investors tab. Complete financial results will be available when we file our Form 10-K with the SEC. Today’s call is being recorded. A replay will be available through May 17, 2016 at 1888-843-7419 from the United States and 1630-652-3042 internationally. The passcode is 42398569. Before we begin, I want to remind you that any statements during this call other than statements of historical fact are forward-looking statements subject to known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements include statements regarding our anticipated revenues and expenses for 2016 and beyond, the pace of Korlym’s acceptance by physicians and patients, the anticipated contributions of our sales organization. The cost and timing of preclinical and clinical trials whether conducted by us or by our academic collaborators, and the results of such trials, the clinical attributes and advancement of our next-generation selective cortisol modulators, including CORT118335, 125281, 122928, and 125134 the protections afforded by Korlym’s orphan drug designation for Cushing syndrome or our other intellectual property rights including our patents concerning the use of cortisol modulators to treat triple negative breast cancer and castration-resistant prostate cancer. These and other risks are set forth in our SEC filings, which are available at our Web site, corcept.com, or from the SEC’s Web site, sec.gov. We disclaim any intention or duty to update any forward-looking statement made during this call. Now, I’ll review our first quarter financial results. Corcept’s net revenue in the first quarter of 2016 was $16.1 million compared to $10.1 million in the first quarter of 2015 a 59% increase. We expect our growth to continue and reiterate our 2016 revenue guidance of between $76 million and $81 million. In the first quarter Corcept recorded a GAAP net loss of $19,000 compared to a net loss of $4.8 million or $0.05 per share in the first quarter of last year. Our cash balance at quarter end increased to $40.7 million up from $40.4 million at December 31st. Our increase in cash is after payment of $3 million in principal and interest under our capped royalty financing arrangement. We expect to make our final payment under that obligation in 2017. As we have said in past calls, we believe revenue from our Cushing syndrome business together with our cash on hand will be sufficient to fund our planned activities, which include fully funding our Cushing syndrome franchise, completing our Phase 1/2 study of Korlym for the treatment of triple negative breast cancer and if that study produces positive results conducting a Phase 3 study, conducting Phase 2 studies of our proprietary selective cortisol modulator CORT125134 in both Cushing syndrome and solid tumor cancer cancers, advancing to the clinic at least two more of our next-generation cortisol modulators, and repaying the balance of our capped royalty financing obligation. I will now turn the call over to Dr. Belanoff. Joe?

[Joseph Belanoff:]

Thank you, Charlie, and thank you all for joining us. Before I talk about our recent results and key development programs I want to set our first quarter accomplishments in context by briefly discussing Concept’s business model which is different from that of most other biotech companies. First the scope of the therapeutic platform we are developing, cortisol modulation, is exceptionally broad. Our research together with the work of our academic collaborators around the world has shown that cortisol also known as the stress hormone plays a role in many serious illnesses. Pre-clinical and clinical studies using mifepristone the active ingredient in our approved product Korlym and proprietary selective cortisol modulators have generated promising data in a wide range of disorders. Most prominent of these is Cushing syndrome which Korlym treats and for which we are advancing our lead selective cortisol modulator CORT125134 to Phase 2 this quarter. Studies of Cortisol modulation as a potential therapy have also yielded positive results in oncologic diseases such as triple negative breast cancer, ovarian cancer, and castration-resistant prostate cancer, metabolic disorders, such as antipsychotic induced weight gain and non-alcohol fatty liver disease and psychiatric indications such as post-traumatic stress disorder and alcohol and cocaine dependence. The second and perhaps most uncommon feature of Concept’s business model among biotech companies at least is that our revenue pays our plan development program. To be sure our top priority right now is not increasing our cash reserves, our bottom-line will fluctuate from quarter-to-quarter as we use our increasing revenues to broad and advance our cortisol modulation platform. Nonetheless we’ve built a fundamentally sound business that has grown significantly since Korlym’s launch and will we believe grow much more. Finally, an important feature of Corcept’s business model is that we’re able to rely on the work of our academic collaborators to identify target indications efficiently and in many cases to product the preliminary pre-clinical and clinical data we need to develop medications. This distributed approach to research and development has important advantages from the perspective of Corcept it is very efficient. In return for providing our independent investigators of mifepristone or samples of our preparatory molecules we receive access to data generated by their creative and insightful research that informs our development decisions. We initiated our own oncology program for example, because pre-clinical and clinical work by researchers at the University of Chicago had generated compelling evidence and virtually no cash cost to us, that cortisol modulation can be used to treat certain solid tumor cancers. Now that I pointed out some of the less common and valuable attributes of Corcept’s business a therapeutic platform and portfolio of compounds with the potential to produce treatments for a wide range of diseases, a self funding operating model and a development program that benefits from the expertise and findings of academic researchers around the world, let me summarize our most recent results. As Charlie mentioned, revenue from our Cushing syndrome business grew 59% in the first quarter, compared to the first quarter of 2015. We expect growth to continue and have reiterated our full year 2016 revenue guidance of between $76 million and $81 million. During the first quarter our cash balance increased slightly, even after payment of $3 million in principal under our capped royalty financing arrangement. In an important step towards securing our Cushing syndrome franchise, our lead selected cortisol modulator CORT125134 will enter Phase 2 to treat patients with Cushing syndrome by the end of this quarter. Our expectation based on substantial pre-clinical and clinical data, is that CORT125134 will share Korlym’s effectiveness while having a significant advantage of not causing the side effects associated with Korlym’s infinity for the progesterone receptor, such as irregular vaginal bleeding. Our oncology program continues to progress, our Phase 1/2 trial of mifepristone in combination with eribulin will generate results by mid-year. We’ve broadened our oncology program significantly by starting a Phase 1/2 trial of CORT125134 in combination with nab-paclitaxel which is the generic name Celgene's drug, Abraxane to treat patients with solid tumor cancers. Lead candidates from our proprietary portfolio of selected cortisol modulators, continue to progress towards the clinic. CORT118335 has shown promise in animal models of fatty liver disease and other metabolic disorders. We expect it to enter Phase 1 by this time next year. CORT122928 is effective in animal models of Cushing syndrome and alcohol withdrawal. CORT125281 is a candidate for treating ovarian cancer, triple negative breast cancer and castration-resistant prostate cancer. These compounds are also moving towards Phase 1 next year. As they progress we’re conducting our own research and monitoring the work of our academic collaborators to identify therapeutic targets. I’ll briefly review our key programs and stop to answer your questions. As most of you know our first product Korlym’s has been approved for the treatment of endogenous Cushing syndrome an orphan disease that affects about 20,000 patients in the United States. Cushing syndrome is the archetypal disease of cortisol excess, it is caused by a tumor that produces either cortisol or ACTH a hormone that produces that causes the body to produce cortisol, because there are cortisol receptors in nearly every human tissue type, patients with Cushing syndrome become sick in many ways, left untreated the disease can be deadly, approximately half of patients with Cushing syndrome are cured by a surgery, the other half approximately 10,000 patients in the United States are candidates for treatment with Korlym. In the first quarter of 2016, we added new patients and new prescribers as we’ve done every quarter since launch. Physicians who had already prescribed Korlym introduced new patients to the medication. Our clinical specialist and medical science liaisons continue to refine the way they speak to endocrinologist about Korlym as a treatment for Cushing syndrome. Our patient advocates and specialty pharmacy personnel continue to improve the support they provide patients. These tightly coordinated activities contributed to our first quarter revenue growth. Just as important, these activities continues to solidify our position in the Cushing syndrome market, their highest emphasis is on increasing our knowledge of the disease and making sure the patients are supported in every point of their treatment. We expect significant growth in our Cushing syndrome business over the coming years, many of the 10,000 or so patients, who could benefit from Korlym are yet to use it. We are constantly refining our skills to ensure that every patient who can be helped by Korlym will get a chance to try it. We have said before, most recently in a press release issued last week and you can find it on the Investors tab of our Web site that we plan to solidify our position in the Cushing syndrome market by advancing next-generation cortisol modulator CORT125134 to Phase 2 later this quarter. Let me provide a bit of background as to why we think this compound is so promising. Although Korlym is in excellent treatment for patients with Cushing syndrome it has some drawbacks the chief being that it blocks the progesterone receptor and in some women causes endometrial thickening and irregular vaginal bleeding. Non-life threatening manageable side effects but ones the patients and physicians would prefer to avoid. CORT 125134 is a potent infinity for the cortisol receptor also known as the glucocorticoid receptor or GR for short but does act at the progesterone receptor and so it will not cause the side effects I’ve just described. Further, data from the compound’s Phase 1 trial show that it appears to share Korlym’s ability to potently reverse the effects of excess cortisol activity, the essential quality in treating Cushing syndrome. Because it appears so far to share Korlym’s efficacy but without its propensity to cause endometrial thickening or irregular vaginal bleeding, we believe that for some patients CORT125134 will prove to be superior to Korlym. Our Phase 2 trial will be open label and enroll 30 patients. We look forward to seeing the data it produces. Before I discuss the particulars of our oncology program, let me briefly explain why we believe cortisol modulation can be used to treat certain types of cancer. In some cancers such as triple negative breast and ovarian cancer, activity at the cortisol receptor promotes tumor growth. To simplify, after binding to GR, cortisol stimulates genes that retard cellular apoptosis. Modulating cortisol’s activity with a competitive GR antagonist such as Korlym CORT125134 one of our other next generation compounds should help combat the disease by increasing the tumor apoptosis triggered by chemotherapy. There is another more systemic mechanism. Cortisol suppresses the body’s immune response. This has the benefit of reducing the frequency of auto-immune diseases but also reduces the immune system’s ability to fight certain cancers. The realization that the patient’s own immune system can be enlisted to treat the disease has fueled the current interest in checkpoint inhibitors, including PD-1 inhibitors. What has been less widely appreciated is that cortisol modulations’ ability to bolster the immune system may also be a powerful therapeutic tool, especially when combined with another anti-cancer agent, such as a chemotherapeutic agent or PD-1 inhibitor. In cancers such as melanoma that are particularly susceptible to the body’s immune response cortisol modulation may even proven to be useful without a companion agent. Our oncology program is based on the insights I’ve just described which are originated with our academic collaborators and have been validated by our own studies in animal models of different tumor types. In the press release we issued last week we provided data showing mifepristone and CORT125134’s efficacy in mouse models of triple negative breast cancer, prostate cancer and colon cancer. At mid-year we expect to have efficacy results from our Phase 1/2 trial of Korlym in combination with the drug eribulin to treat metastatic triple negative breast cancer. As a reminder, eribulin is the generic name for Eisai’s drug Halaven. By way of background, patients with triple negative breast cancer have tumors that do not express the three receptors estrogen, progesterone and HER-2 to which medications like tamoxifen or Herceptin bind, which means that those medications cannot treat the disease. The great majority of triple negative breast cancer tumors do, however, express GR. 40,000 women in the United States are diagnosed with this disease every year. There is no FDA approved treatment and patients with metastatic disease have a diet course. Our open label trials enrolling 20 women with GR positive metastatic triple negative breast cancer, each of whom will receive 300 milligrams of Korlym everyday and 1.1 milligram per meter square of Halaven on a 21 day cycle. The preliminary efficacy data we presented at the San Antonio Breast Cancer Symposium in December 2015 were promising. We will need to complete this study before deciding the next appropriate steps. In the first quarter, we opened the first site in our open label Phase 1/2 trial of CORT125134 in combination with nab-paclitaxel to treat solid tumor cancers. The trial’s design is similar to that of our trials of mifepristone plus eribulin to treat triple negative breast cancer. The first Phase will determine the maximum tolerated dose in patients with any solid tumor cancer susceptible to treatment with nab-paclitaxel. Once a maximum tolerated dose is identified we plan to open 20 patient expansion cohorts to test the combinations’ efficacy in one or more of the solid tumor cancer studied in the dose finding Phase. Possible target indications include triple negative breast cancer, castration-resistant prostate cancer, ovarian cancer, pancreatic cancer, and sarcoma. We may also study CORT125134 in combination with different companion therapeutic agents including PD-1 inhibitors. I will close with a brief discussion of Corcept’s portfolio of preclinical programs. As many of you know, we continue to advance leading candidates from our proprietary portfolio of more than 300 selective cortisol modulators. These compounds all bind to GR and none are active at the progesterone receptor but and this is important they behave somewhat differently from one another some appear to be tissue specific for instance others are not. This variability should allow us to develop compounds that target specific indications. For instance, in animal models, CORT118335 appears particularly potent in fatty liver disease an illness suffered by millions of Americans but is not as active as CORT125134 in animal models of Cushing syndrome. The differentiated quality of these compounds will allow us to develop medications for relatively common disorders without undermining our more focused product offerings. The preclinical development of our next generation Cortisol modulators continues to advance. CORT125134 is obviously the farthest along, but CORT125281, CORT118335 and CORT122928 continue to progress. We hope to have them in human testing early next year. As our preclinical work progresses, we will look to our own research and studies of our academic collaborators to identify therapeutic targets. To sum up, revenue from our Cushing syndrome business reached $16.1 million in the first quarter, a 59% increase from the same period last year. We reiterate our 2016 revenue guidance of $76 million to $81 million. We continue to believe that our cash flow together with our cash on hand will fully fund the planned development of our cortisol modulation platform which shows increasing promise in providing treatments for a wide variety of serious illnesses. Our lead next generation compound CORT125134 will enter Phase 2 for the treatment of patients with Cushing syndrome at the end of this quarter. Preliminary pre-clinical and clinical data suggests that this compound may offer patients Korlym's benefits but without the side effects associated with Korlym's affinity for the progesterone receptor. Our oncology program also made important strives. The preliminary efficacy data from our Phase 1/2 trial of Korlym to treat triple negative breast cancer that we reported last December was encouraging and we expect to complete the trial by midyear. CORT125134 began its own Phase 1/2 trial in combination with nab-paclitaxel for patients with solid tumor cancers. The trial’s flexible design will allow us to investigate other companion agents and tumor types should we chose. Finally promising next-generation compounds continue their pre-clinical development, we hope to advance several of them to the clinic by this time next year. I’ll stop here and answer any questions.

[Operator:]

We will now begin the question-and-answer session. [Operator Instructions] And we have a question from Charles Duncan from Piper Jaffray. Please go ahead.

[Charles Duncan:]

So my first question really is on the ASCO Meeting coming up, it sounds like I mean you've been making progress on triple negative breast cancer with mifepristone and I'm just kind of wondering why you didn't have that data for ASCO, is it pushing out impart due to patient enrollment and then also how many patients do you anticipate being able to include in that data in midyear?

[Joseph Belanoff:]

Okay, so it's a couple of questions. Charles we actually will have a -- in fact we've already submitted our abstract for it and it will be presented at ASCO and we will present an up to the moment evaluation of where we are at that point, but the study is still ongoing. And it is not complete, we don't anticipate it'll be complete, because patients are still active in it, at the time of ASCO and of course we'll produce the results as it will finally complete. But as you know our idea really as this is an open label study and this is a major meeting so we thought that as we did with the San Antonio Breast Cancer Meeting that we would present exactly where we stood at the time of the ASCO Meeting and we will do so, although as I said I think the study will continue to go beyond that point in time.

[Charles Duncan:]

Okay. So, you're not really targeting, but you're targeting midyear but in addition there'll be information at ASCO?

[Joseph Belanoff:]

That’s right mid-year is our best estimate but we actually will give up to the date -- up to the moment information at ASCO as to exactly where we stand at that point.

[Charles Duncan:]

May be that is done to evaporate syndromes that response et cetera, right?

[Joseph Belanoff:]

That’s correct, Cushing free survival response rate so on and so forth. We will characterize the patients as broadly as we can just as we did at the San Antonio Breast Cancer Meeting to give you the most update we can at that point.

[Charles Duncan:]

And then moving onto 134 in terms of oncology, I'm wondering what kind of patients you'd like to have in that study, do they all need to be expressers of glucocorticoid receptor, will you be testing for that or will you just be kind of taking all comers and then testing for that?

[Joseph Belanoff:]

Well Charles I am actually going to take the opportunity to take a breath and introduce you to Bob Fishman, I think you might have met at the last call, Bob is our Chief Medical Officer and he can answer that question for us.

[Bob Fishman:]

As you know the study will have two parts, the first is dose finding and then we will advance to a variety of dose expansion cohorts, the dose finding phase of the study will enroll all comers with solid tumors for whom the investigator has decided that nab-paclitaxel is an appropriate treatment, we will be of course assaying for GR positivity but that will not be a requirement for their entry in beginning, in the entry -- excuse me at the time of entry into the study. Similarly for the dose expansion, cohorts we will, it's typical that the results of the GR assay become available some time after enrollment that was one of the lessons learned from the mifepristone eribulin trial so we will gather those data but again at the time of entry patients who are suitable candidates will be allowed to enroll into the selected dose expansion cohorts which are to be determined at this time.

[Joseph Belanoff:]

Hi Charles, let me just elaborate just a little bit on that and a very interesting thing that we've learnt last summer was we did a large tumor bank screening I think the first one which had ever been done certainly by far the largest for GR positivity in a variety of tumors and we actually found several interesting thing, one of which we’ve already talked about, which is that triple negative breast cancer although in a literature really talked about sort of being 25% to 50% GR positive, it is really a proven to be much closer to 100%, certainly above 75% and that’s really proven to be the case in the current study we’re running. Now what’s interesting about that is I think that there are tumors that are in fact very GR positive and some tumors which are not so GR positive, but we’re really still gathering that information and I think that really will be part of what we’re thinking about as we go to the expansion cohorts, whether or not we really do have to select along those lines or whether or not it's a particular tumor where one would expect most of the patients to be GR positive and therefore be in some sense automatically eligible for treatment with the GR antagonist.

[Charles Duncan:]

I was wondering if this could be potentially companion diagnostic in the future, but it seems like you’re still defining what GR positivity means and how it correlates with potential response in these patients?

[Joseph Belanoff:]

And whether or not in fact the prescreening tool is actually the most efficient way to go, but yes it is something that we think about all the time.

[Charles Duncan:]

And then my last question and then I’ll hop back in the queue it is more operational onto Korlym revenues had a good year-on-year growth. I am wondering about the quarterly or sequential growth? I know that this is a little bit of a mathematical issue, or denominator issue. But I am wondering about the growth rate, if you will, and if that’s a function of something that happened perhaps last year that was made it very high versus this? And what are you planning to do to continue to drive Korlym revenue and growth?

[Joseph Belanoff:]

Charles I am just going to point you to Charlie who is going to answer the question.

[Charlie Robb:]

We had a challenge in the first quarter of this year that’s the same as a challenge. We really had in all of the first quarters we’ve operated in since launch, which is that as you know insurance companies tend to put their patients, especially their patients, orphan drug patients through a reauthorization process at the start of every year. And for a lot of patients this is really bad news because they’re denied access to medicine while they straighten out their insurance, going to go through the reauthorization process. We don’t do that to patients we continue to provide them with medicine and a system as we can as they work through the reauthorization, which we do with great success typically. But what that does mean for us is that in the first quarter typically we have patients shift from commercial to free drug for a time before coming back. So, we do the right thing by the patients to make sure they get their medicine. This is a challenge that we anticipate every year and it's something that we took into account when we generated our revenue guidance, which is why we are now for the year -- which is why we’re comfortable reiterating it now. We put in place programs this year to shorten that time of the reauthorization, some of them worked, many of them didn’t and we already are working on our ideas for next year. So that’s just a headwind that we run into every first quarter.

[Operator:]

Our next question comes from Christopher James from FBR Capital Markets. Please go ahead.

[Christopher James:]

I guess, yes my first question is on the existing Cushing’s business. Maybe either one of you guys can speak to the incremental effects of the salesforce expansion that you’re seeing and maybe do you see an opportunity to potentially further expand the sales team?

[Joseph Belanoff:]

And let me introduce the whole audience to Sean Maduck who is our Senior Vice President of Commercial and runs the whole Cushing syndrome franchise.

[Sean Maduck:]

Chris thanks for the question and maybe just stepping back just to remind everyone on sort of the growth of last year. We made a decision early in the year to increase the size of the salesforce pretty substantially by about eight clinical specialists up to 25. And a good part of the early part of last year was training up those individuals and getting them into the field and one thing we’ve touched on previously is that it takes up to five to seven touches to actually move a naïve physician to being a productive physician. And I can tell you that that expanded field force as well as our existing clinical specialists have been productive. We’ve seen an increase in productivity both in Q4 as well as in Q1 and dispersed enrollment activity from across the country. And one other thing that I think is important to remind everyone of in terms of our model is that, when patients first come on board it's a chronic condition and it takes a while for these patients to dose to their most efficacious dose. So they come in at 300 milligrams and it does take some time to get to the optimal dose which then drives from a value standpoint revenue in the organization. So there is anywhere for three to six month lag on that increased activity to actually sort of appear in terms of output from a model standpoint. So to your second part of your question is in terms of expansion, I mean we are always looking at opportunities to increase the size of the field where appropriate. We will not add bodies to just add bodies, but where we feel we can hire the right talent in a territory where you can have incremental gain on the organization we will do that. So, since we know we last talked we actually have increased the size of the field by a couple of clinical specialists and we're now at 27 plus our four regional managers and we also have eight MSLs and one MSL head, so we continue to again look for the opportunistic both territory and an individual to bring into the organization to grow when appropriate.

[Joseph Belanoff:]

Hi Chris, I'm just going to, just because I think it's important, I want to make sure the whole audience gets it, I just want to reiterate a couple of things that Sean said, one is that as we talked about before we think it takes -- we've now done it for multiple years, really about six months to train people up to the point where they are really productive and that for us was about the first of the year. The new group of reps were very productive in the first quarter but then again as Sean really points out we can see their productivity but it doesn't show up in a financial way as much as it's going to show up as the year goes along just because of this being a chronic illness in the way the medication is dosed, so again, as we expected -- that was how we hoped it would go and we hope fingers crossed that it continues in that way as the rest of the year progresses.

[Christopher James:]

And then on CORT125134, can you discuss maybe what you're seeing or how you are thinking about this pharmacologically -- really sort of what drives the decision to combine it with Abraxane on that nab-paclitaxel versus eribulin with mifepristone just what is the sort of rationale there?

[Joseph Belanoff:]

Yes, I think I can really answer your question more generally which is that -- at this point in time we think that GR antagonism can enhance any treatment that is -- that has a tumor that is potentially sensitive to cortisol regardless of what the background therapy is. And we're really at sort of the discovery point as to what the best companion therapy might be. As you know with mifepristone there has actually been a study which was done with nab-paclitaxel, we're now doing one with eribulin, there's another one going on with the combination of gemcitabine and carboplatin and there's no a; priority guesses to which the best of those are going to be. We think that this for GR positive tumors, there is an enhancement of chemotherapy no matter what the chemotherapy is. Now it happens that nab-paclitaxel is sort of a broadly applicable chemotherapy, so it's a good first companion agent for 125134, but I just want to make sure everyone understands that this is the first potential combination that we might use, there might be others involved and in some sense you have to start somewhere and this was really a very reasonable place to start. I mean one of the things that we put out in our press release of the last week which I just thought was intriguing it was the very first animal study that we've done but it was an interesting one to do was that we looked at a PD-1 inhibitor in an animal model of colon cancer in combination with CORT125134 and it clearly in a highly statistically significant way enhanced its effect. So, I just think for the audience generally I think you have to understand that I think this is a very interesting modality of treatment and we're really learning ourselves where it can be best be applied, there's really in some sense no more to it than that.

[Christopher James:]

And then finally can you maybe address some of the -- you have a lot going on with the investigator-sponsored trials, I think the post traumatic stress disorder study is pretty interesting maybe can you discuss maybe the rationale and when could we potentially see some data there?

[Joseph Belanoff:]

Yes, I'll try to do it briefly, because I don't want to take the rest of the afternoon for what's really an interesting topic for me. And maybe more interesting for me than almost anybody, but in some sense I think everyone understands that by its very nature post traumatic stress disorder is related to cortisol stress -- I mean we talk about Lehman’s term from stresses actually, the physiologic expression of too much cortisol activity and we really think that potentially by modulating that we might be able to not only treat post traumatic stress disorder but prevent post traumatic stress disorder and maybe really the primary reason is that memories which form under high stress states are very-very different in memories which form under normal stress states and there are potential treatments which can take advantage of that by reducing cortisol activity as patients are actually brought through on a psychotherapeutic level to deal with the trauma that they faced. Now the Bronx VA ran a pilot study with mifepristone I guess about four years ago, small study but with big effect size quite positive results. And VA is now paying for a much larger study which is ongoing, again arms length from core septal that we provide medication to try to utilize cortisol antagonism as a treatment in post traumatic stress disorder and as I always point out to people the timeline is not as tightly under our control as when we do our own study, but it is progressing, we know that it is, and we think that results in it -- well certainly those cards should be turned over in the next 12 to 18 months. And I think there really is a lot of good preclinical and actually human data that would point us in the direction that this might be an effective therapy. So, yes that is one of the investigator studies which has a particular interest to me it's got a relatively near term readout and good science behind it.

[Operator:]

And our next question is from Roy Buchanan from Janney Montgomery. Please go ahead.

[Roy Buchanan:]

I guess just on the same lines as the last question. Can you update us on the alcohol dependence studies, what’s going on there?

[Joseph Belanoff:]

Yes, I’d be glad to Roy and thank you for asking about it. I think as many of you know, there is -- who follow the Company more closely, there really is very interesting scientific program, which is now in later years proceeded to a clinical program on the use of cortisol modulation to help with addictions, and you’ve asked specifically about the alcohol addiction, I’ll point to that. Basically, and again I’ll tell the story very briefly. You probably all heard some form of the joke, it's easy to but it's not funny. But it's easy to quit alcohol I’ve done it 100 times, that’s the problem. The problem is that it's actually very stressful for people who are -- used alcohol on a chronic basis to stop drinking. And one of the things that where an intervention really could might be most effective is actually at the beginning as people begin to come off alcohol and see if they can really get them to stay off. And I think that the issue really is that the stress that they feel when they stop drinking is actually very supportive of the cravings they feel to restart drinking. And if it can be modulated in that early period, and essentially in the first few weeks before that, you might really do a much better job of getting people who really do want to quit drinking to be able to quit drinking. And again I’d point you to the academic papers, this started as an animal based model and then ultimately was in a double blind human study which was done at Scripps and is now in a much larger study also being led by Scripps. I know it is enrolled well, it's again not a joke but there are plenty of people who want to quit drinking and we also expect that that data although again I have to always give the same caveat not under our control but that data will actually turnover results in the next 12 to 18 months too.

[Roy Buchanan:]

And then just circling back on the 125134, in oncology you guys had the press release with some interesting data in the mouse data graph last week what looks like there was at least a trend of efficacy superior to mifepristone and PD-1 inhibition for 125134. Do you guys have any ideas about a possible mechanism why that might be the case?

[Joseph Belanoff:]

Well you know I have to just answer that more broadly. It's a subtle and interesting question. One of the things that we -- and again I’ll take you back again for context. For those who follow the Company for a long time our initial goal was really to see if we could just create mifepristone without progesterone antagonism for all the reasons we talked about many-many times and really come up with a single follow on drug. But when we started to actually do empirical testing on it we found out that these compounds were not identical although they all shared the property of cortisol modulation with no activity at progesterone. And it really turned out I think again on empirical basis as we started testing them, some were more potent to creating insulin sensitivity, some were more potent to creating weight loss, some got into the brain some didn’t get into the brain. And then as we began to test them in our oncologic models some were more potent in mifepristone and some were less potent in mifepristone. And it turns out that 125134 for reasons we don’t entirely understand but really are exploring with our academic investigators as well as our own work, it's pretty consistent. Mifepristone is a good companion agent in the preclinical model so far 125134 has been even stronger. And we’ll just have to see whether that actually translates to the human effect in the study that Bob and his group are currently running.

[Roy Buchanan:]

And then I had a question to follow up also on the, from the prior study of Abraxane plus mifepristone in breast cancer. I think investigators made some comments about metabolic interactions and influencing the dosing, is that not going to be the case with 125134 is it metabolized through different pathway and are you not as worried about potential dosing interactions? Thanks.

[Joseph Belanoff:]

Well, it's actually drug-drug interaction is often something you look at in these early studies. And there is potential for drug-drug interactions with CORT125134. We don’t know exactly how it's going to interact and it's part of what we look at in this form of the study, so, to be determined.

[Roy Buchanan:]

And then I had one last question and then get out of the line. But just wondering about partnering interest I assume you’re probably getting inbound interest on the compound. Are you guys aggressively looking for partnering of any of the compounds? You guys have a pretty large library or are partners kind of waiting for to see you guys get through a certain phase of development? Thanks.

[Joseph Belanoff:]

Well, I think that you’re certainly right in a very important regard is that we have a very interesting portfolio of pipeline compounds and maximizing their utility to patients is really our goal. And what can get us there in the most efficient way is what we want to do. I will tell you at this point in time kind of two facts. One, we have the money to advance them in the way that we would like to at this point in time. And I think that’s a very nice position to be in. The other is that we’re really as I tried to point out through this call still really characterizing them. There is still information as to where they will work best that is unknown and I think that they increase in value as we actually do that research and that’s going to happen again as we talked about in the timeframe that I discussed the really again in the next 12 to 18 months we’ll have a lot more information about where these medications are potentially most useful and can have broader conversations on topics at that point. But we have the money to do the information gathering. We think that the information gathering adds value and that’s what we’re doing.

[Joseph Belanoff:]

Okay. All right, well thank you very much for all those who participated in this quarter's call and look forward to talking to you next quarter.

[Operator:]

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.