Corcept Therapeutics' (CORT) CEO Joseph Belanoff on Q4 2015 Results - Earnings Call Transcript

| About: Corcept Therapeutics (CORT)

Corcept Therapeutics Incorporated (NASDAQ:CORT)

Q4 2015 Earnings Conference Call

January 28, 2016 5:00 PM ET

Executives

Charlie Robb – Chief Financial Officer

Joseph Belanoff – Chief Executive Officer

Bob Fishman – Chief Medical Officer

Dave Penake – Senior Commercial Officers

Sean Maduck – Senior Commercial Officers

Analysts

Sarah Weber – Piper Jaffray

Roy Buchanan – Janney Montgomery

Christopher James – FBR Inc

Boris Peaker – Cowen

Alan Leon – Senior Analyst

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. Charlie, you may begin.

Charlie Robb

Thank you. Good afternoon. My name is Charles 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 fourth quarter 2015 and full-year preliminary financial results, 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 February 12 at 888-843-7419 from the United States and 630-652-3042 internationally. The passcode is 41568920.

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 preliminary financial results for the fourth quarter of 2015, our anticipated revenues and expenses for 2016 and beyond, the pace of Korlym’s acceptance by physicians and patients, the anticipated contribution of our sales organization.

The cost and timing of preclinical and clinical trials and the results of such trials, the clinical attributes and advancement of our next-generation selective cortisol modulators, the protections afforded by Korlym’s orphan drug designation for Cushing’s syndrome or our other intellectual property rights including our patent concerning the use of glucocorticoid receptor antagonists to treat triple negative breast cancer.

These and other risks are set forth in our SEC filings, which are available at our website, corcept.com, or from the SEC’s website, sec.gov. We disclaim any intention or duty to update any forward-looking statements made during this call.

Now, I’ll review our preliminary financial results. Corcept’s net revenue in the fourth quarter was $15 million, compared to $9 million in the fourth quarter of 2014, a 66% increase. For the full year, revenue was $50.3 million, compared to $26.6 million in 2014, an 89% increase. We expect growth to continue with full-year 2016 revenue of between $76 million and $81 million.

In the fourth quarter, Corcept earned its first GAAP profit. Preliminary GAAP net income for the fourth quarter of 2015 was $0.01 per share, compared to a loss of $0.04 per share in the fourth quarter of 2014. For the full year, the Company’s GAAP net loss was $0.06 per share compared to a GAAP net loss of $0.31 per share in 2014.

It is important to note that our 2015 audit is ongoing and our figures for 2015 are preliminary. Our complete and final financial results will be available when we file our annual report on Form 10-K with the SEC. Our cash balance at year end was $40.4 million, compared to $36.5 million at the end of the third quarter. The $4 million increase in our cash balance is after the payment of $2.8 million in principal and interest under our capped royalty financing arrangements. We expect to make our final payment under that obligation in 2017.

As we have said in past calls based on our current plans, which include fully funding our Cushing’s 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 in both Cushing’s syndrome and solid tumor cancers with our proprietary compound CORT125134, advancing to the clinic at least two more of our next-generation compounds and repaying the balance of our capped royalty financing obligation. We believe revenue from our Cushing’s syndrome business together with our cash on hand will be sufficient to fund our expected activities.

I will now turn the call over to Dr. Belanoff. Joe?

Joseph Belanoff

Thank you, Charlie, and thank you all for joining us. Corcept seeks to help patients by developing and commercializing medications that modulate the effects of cortisol, widely known as the stress hormone. Our research and research by the dozens of academic investigators with whom we collaborate has shown that cortisol modulation has therapeutic potential in many serious illnesses including oncologic disorders such as triple negative breast cancer, ovarian cancer, and castrate resistant prostate cancer, psychiatric indications such as post-traumatic stress disorder and alcohol and cocaine dependence, metabolic diseases such as antipsychotic induced weight gain and non-alcohol fatty liver disease and Cushing’s syndrome which our first medication Korlym has been approved to treat.

Let me briefly recap our recent results. As Charlie mentioned, our Cushing’s syndrome business grew strongly in 2015. Revenue increased 89% to $50.3 million. We expect significant growth in 2016 with revenue reaching between $76 million and $81 million. Our oncology program continues to progress in December at the San Antonio breast Cancer Symposium, we announced preliminary efficacy results of our Phase 1/2 trial of Korlym in combination with the chemotherapy drug eribulin to treat women with triple negative breast cancer, a severe form of the disease with a poor prognosis and no FDA approved treatments.

We are about to begin a Phase 2 trial of our lead next-generation cortisol modulator, CORT125134, to treat patients with one or more types of solid tumor cancer. The first clinical sites in this trial are expected to open by the end of this quarter. We’re also about to begin a Phase 2 study at CORT125134 to treat patients with Cushing syndrome. Our hope is that CORT125134 will share Korlym’s effectiveness without causing the side effects associated with Korlym’s affinity for the progesterone receptor.

As many of you know, we have created a large library of next-generation cortisol modulators. CORT125134 is our lead next-generation compound, but others are progressing towards the clinic. One of them, CORT118335, has shown promise in animal models of fatty liver disease and other metabolic disorders. Another CORT122928 appears to be active in animal models of alcohol withdrawal. I had mentioned a third compound, CORT125281, on past calls.

It is a candidate for treating certain solid tumor cancers such as castration-resistant prostate cancer, ovarian cancer, and triple negative breast cancer. As these compounds undergo pre-clinical testing, we will be looking to the results of our own research and that of our academic collaborators to pick their optimum therapeutic targets. Before I give more detail about our key programs, I want to pause for a moment to note that Corcept recently achieved an important financial result.

In the fourth quarter of 2015, we earned our first GAAP profit. We plan to invest a substantial portion of our increasing revenue, continuing the development of proprietary selective cortisol modulators. While our financial results will vary a bit from quarter-to-quarter, we have become and expect to remain fundamentally self-funding business. Our Cushing's syndrome franchise now supports our entire business even as we expand our development activities and retire our royalty debt, which we expect to distinguish completely in 2017.

I’ll briefly review our key programs and start to answer your questions. As I’ve mentioned our sales of Korlym grew substantially in 2015 and we are expecting significant growth in 2016. But I do not want to focus on our recent results and our near-term forecast that causes to lose sight of the long-term potential of the Cushing’s syndrome market. We added new prescribers and new patients in the fourth quarter of 2015 just as we have in every quarter since Korlym’s launch.

Nonetheless, the vast majority of 10,000 or more patients, who could benefit from Korlym have yet to use the drug. We believe Korlym has many years of growth ahead of it. Korlym is a very effective treatment. This has always been its most important quality both as a medication and as a commercial product. But the mere fact of its efficacy is not sufficient to get Korlym to every patient it could help.

Endocrinologists are particularly busy clinicians and conservative prescribers of new treatments and can take as many as seven visits from a Corcept clinical specialist before an endocrinologist who is not familiar with Korlym write their first prescription. After the prescription is written both patient and physician often require a significant support from Corcept’s patient advocates, clinical specialists and medical science liaisons as they begin treatment and arrive at an appropriate dose. We have learned that there’s predictability to this process, which just helps us to fine tune the support we offer.

We have also learned that it takes time. The clinical specialists we hired in 2015 have been doing the hard work of educating physicians about Korlym and the benefits cortisol modulation can provide their patients. We were just beginning to see their efforts results in new prescriptions. We expect all of our clinical specialists to contribute significantly to our growth this year.

The advancement of our lead next-generation cortisol modulator, CORT125134, to Phase 2 is an important step in the development of our Cushing’s syndrome franchise. For all its power as a treatment for Cushing’s syndrome, Korlym has certain drawbacks, the chief being that it blocks the progesterone receptor and terminates pregnancy. In some non-pregnant women, progesterone receptor blockade also causes endometrial thickening and irregular vaginal bleeding. Non-life-threatening manageable side effects, but ones the patients and their physicians would prefer to avoid.

Data from CORT125134’s Phase 1 trial shows that it appears to share Korlym’s ability to potently reverse the effects of excess cortisol activity, the essential quality in treating Cushing’s syndrome. But unlike Korlym, CORT125134 is not active at the progesterone receptor and should not cause the progesterone blocking side effects that I’ve just described. For some patients, CORT125134 made proved to be even better than Korlym. The trials first clinical sites are expected to open by the end of this quarter.

Before I discuss the particulars of our oncology program, I’d like to explain why we believe cortisol modulation whether using Korlym, CORT125134, or another of our next generation compounds may proved to be useful in treating certain types of cancers. In some cancers such as triple negative breast cancer, cortisol activity at the tumors glucocorticoid receptor, GR for short, promotes tumor growth. To simplify, after bind to the tumor’s GR, cortisol stimulates genes, which retards cellular apoptosis. Modulating cortisol activities with the GR antagonist such as Korlym of one – one of our next-generation compounds should increase tumor apoptosis.

There was also another more systemic mechanism at work. Cortisol suppresses the body’s immune response. This is often beneficial as it lessens the frequency of autoimmune diseases. However, it is now clear that activating not suppressing the body’s immune system is beneficial in fighting certain cancers. When a patient undergoes chemotherapy that is designed to promote apoptosis in tumor cells, cortisol’s immunosuppressive anti-apoptotic effect is counterproductive.

Modulating cortisol should help cancer patients own immune system combat their disease. Our research has shown that a large range of tumor types express GR and potential targets for cortisol modulation therapy among them triple negative breast cancer, ovarian, prostate, and pancreatic cancer as well as melanoma. As many of you know we are conducting our own oncologic clinical trials and closely monitoring the work of our academic collaborators.

In December at the San Antonio Breast Cancer Symposium, we presented preliminary 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 drug Halaven. Enrollment in this portion of the trial is ongoing and will eventually total 20 women each of whom will receive 300 milligrams of Korlym every day and 1.1 milligram per meter square of Halaven on the 21 day cycle.

Patients with triple negative breast cancer have tumors but do not express the three receptors: estrogen, progesterone and the HER-2, to which medications like tamoxifen or Herceptin bind, which means that these medications cannot treat their disease. The great majority of triple negative breast cancer tumors do, however, express GR, the receptor to which cortisol binds.

40,000 women in the United States are diagnosed with this disease every year. There was no FDA approved treatment and patients with metastatic disease have a dire course. In December, we presented preliminary efficacy data for 13 patients. These results were encouraging and we look forward to completing the trial. By the end of the first quarter, we plan to open the first clinical sites in a Phase 1/2 trial, CORT125134 in combination with chemotherapy to treat solid tumor cancers.

The trials design will be similar to our current Phase 1/2 trial with an initial dose-finding portion followed by an expansion cohort in one or more cancers, testing the efficacy of the recommended dose. Another of our compounds CORT125281 is a candidate treatment for a number of cancers including castration-resistant prostate cancer, triple negative breast cancer, and ovarian cancer and is now being tested in pre-IND toxicology studies.

I want to close with a brief discussion of Corcept’s portfolio of more than 300 next-generation compounds. We and our academic collaborators have explored the possible use of these novel molecules in a wide range of indications besides Cushing’s syndrome and oncology, including non-alcoholic fatty liver disease, anti-psychotic-induced weight gain, alcohol and cocaine dependence, ALS, and Alzheimer’s disease.

An important fact is that these compounds are all cortisol modulators and none are selective – none are active at the progesterone receptor, but they behave differently from one another in important respects, some appear to be tissue specific for instance. This variability should allow us to develop different compounds for different indications. For instance, CORT118335 appears particularly active in fatty liver disease and illness suffered by millions of Americans, but not as active as CORT125134 in Cushing’s syndrome, a disease with widely disseminated symptoms.

2016 should be a year of substantial advancement for our next-generation cortisol modulators. We’re about to start two Phase 2 trials with CORT125134, CORT125281, CORT118335, and CORT122928 are all in pre-IND testing. We hope to have them in human testing early next year.

To sum up, our Cushing’s syndrome business grew 89% last year and we expect significant growth in 2016 and beyond. We earned our first GAAP profit in the fourth quarter and are confident that our cash flow together with our cash reserves will be sufficient to fund our planned activities including repayment of our royalty obligation without having to raise additional funds.

Our lead next-generation compound CORT125134 will enter Phase 2 study for the treatment of patients with Cushing’s syndrome at the end of this quarter. Preliminary preclinical and clinical data suggest that this compound may offer patients the benefits of cortisol modulation as Korlym does, but without the side effects associated with Korlym’s activity at the progesterone receptor. Our oncology program also continues to advance.

Preliminary efficacy results in our Phase 1/2 trial of Korlym to treat triple negative breast cancer show promise. We look forward to sharing additional results at the ASCO conference in June. CORT125134 will begin its own Phase 1/2 trial for patients with solid tumor cancers by the end of this quarter. Our next-generation compounds continue their development and we hope to advance one or more events in the clinic by this time next year.

I’ll stop here and answer any questions.

Question-and-Answer Session

Operator

[Operator Instructions] And we have a question from Charles Duncan from Piper Jaffray. Please go ahead.

Sarah Weber

Hi, this is Sarah Weber on for Charles. Well, congrats on a strong quarter. My first question is [indiscernible] anything strategic about the site selection for the Cushing’s trial of 134 and could you see that trial helping to raise awareness of the mechanism in Cushing’s?

Joseph Belanoff

Yes, Sarah, nice to hear from you and thank you for the question. I just want to repeat it. The question was site selection for the CORT125134 Cushing’s syndrome study. And that’s a very important question because I think that it’s really worth knowing that well we will have some sites in the United States, including for example the NIH, we will also have multiple sites in Europe for this to this particular trial. And I think that that will really help awareness of the therapeutic modality of GR modulation or Cushing’s syndrome in that group. As you know mifepristone Korlym is approved in the United States and we hope to have CORT125134 approved in worldwide setting. So, yes, in fact site selection is very consequential and thank you for letting me address it.

Sarah Weber

Great.

Operator

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

Roy Buchanan

Hi, guys. Thanks for taking the questions. I had a question about a potential label for 125134 in Cushing’s. Would you expect that to look similar to the Korlym label or different?

Joseph Belanoff

I like just – but my colleagues sitting around the table and I’d like to now introduce you to Bob Fishman, who is our Chief Medical Officer. Bob would you like to handle that question?

Bob Fishman

Yes, sure, and thanks very much for the question. Yes, it is our hope that we will have a broader label. As you know Cushing’s syndrome has a variety of manifestations. And so, we will be looking in the trial at a variety of clinical parameters as before we’ll focus on glucose control, blood pressure control. But, yes, we hope by virtue of that evidence base to have a broader label. And perhaps most importantly because of the lack of effect on the progesterone receptor, we would expect to label without the current black-box warning.

Joseph Belanoff

Yes. And in short, Roy, we’re putting together a series of trials, which we think will allow for the broadest possible label for 125134 in Cushing’s syndrome and really hope to have it available to any patients, who could potentially use it.

Roy Buchanan

Okay, great. Is it – these compounds have any impact on cortisol synthesis or are you looking for compounds that might have an impact on that?

Joseph Belanoff

No, our real mechanism of action that we’re looking for is competitive antagonist at the glucocorticoid receptor, not cortisol synthesis inhibition.

Roy Buchanan

Okay, all right, great. And then I had a question about the IST, the Phase 1/2 of Korlym plus Xtandi. I know it’s not your study, but do you guys have any idea when we might see data from that?

Joseph Belanoff

Well, you’re right. You’ve raised kind of the key issue. It is an academic study being done at the University of Chicago and that sort of arms length that we don’t have this space, full insight into the timetable. But we noticed that study is really progressing and fingers-crossed we actually will see data within the next 12 months from that study.

Roy Buchanan

Okay, great. And one last question, I’ll jump back in the queue. I had a question about the heterogeneity of GR expression in certain tumor types. So, when you say 75% expression level, is that 75% of cells in pretty much all the tumors or is it 75% of tumors with a high level of expression?

Joseph Belanoff

The standard that we’ve used and it really started with I think really closely looking at what was done with Herceptin was that tumors that have a greater than 10% expression of the GR receptor within them. And so, there is variation that runs from 10% all the way to 100%. And I could tell you looking at our own tumor samples they tend to be on the high side, but that’s been the cutoff for our data, so greater than 10% expression within the tumor.

Roy Buchanan

Okay, great.

Operator

Our next question is from Christopher James from FBR Inc. Please go ahead.

Christopher James

Hi, good afternoon guys and thanks for taking my questions. And let me congratulate you on an excellent quarter and generating your first GAAP profitable quarter.

Joseph Belanoff

Thanks, Chris.

Christopher James

I guess – yes, thanks, Joe. So just starting I guess on Cushing’s maybe could you provide a little bit of commentary around what you’re seeing with respect to the average dose of Korlym. And do you see any room for upside in the daily dose currently being used?

Joseph Belanoff

I would like to – Chris, thank you for the question. I’d like to introduce our two Senior Commercial Officers, Sean Maduck is here and Dave Penake. Sean just for those of you who may need him in the future is really responsible sort of broadly for patient acquisition and Dave Penake is around patient retention. And Dave, do you like to handle this question?

Dave Penake

Yes, thank you, thank you Joe. Well, Christopher thanks for the question. I think to start with one thing we have talked about it in the past is that our average dose commercially was lower than what we have seen in the seismic study. And one of the things that we’ve taken into account to try and manage that and improve that is we’ve implemented what we call retention programs here.

What we’re really trying to do is follow every patient, help every patient, help make sure that the patient and the physician are having the right discussions, where they can find the optimal benefit of the drug. What that’s led to is patients who are on longer, patients – more of our enrolled patients become chronic. And when they do so, it’s because they’re getting a very effective dose and or very effective treatment. And a lot of that has to dose.

So we’ve continued to see rising dose over the last couple of quarters. We expect that to continue, we do not know where it tapers off. But we think somewhere in the range where the seismic study landed would be appropriate.

Sean Maduck

And the other thing I’d like to add to that Chris just to Dave’s point, which I think was well expressed, is that, yes, it was a little frustrating because we felt like patients early on were being under dosed and weren’t really getting the maximum effect that they might get from the drug. That has been less and less of an issue with Dave’s retention programs and we are now seeing doses that we’re in the range of the seismic study. And we think that that’s going to continue over time and those two things are really sort of inexorably tied together. Good retention is because of good dosing and good dosing causes good retention.

Christopher James

Got it. And remind me what the dose 750 mg?

Sean Maduck

It was 750 – yes, and just it was the whole lot, the mean dose was about 750, the medium dose was about 900.

Christopher James

Got it, okay. And then just moving to the competitive landscape, one question we’re getting in particular from investors. Is on a competitive drug COR-003 levo, I think you’re familiar with it levo ketoconazole. We are aware that ketoconazole had some issues with LFTs. I guess, may be in broad strokes, maybe give your thoughts on a similar agent and do you think it would have a different profile?

Joseph Belanoff

Well I mean the first thing I’d really like to say is, I think it’s terrific for these patients that people are doing research in this area. I mean this was a really an underserved group for many, many years. And there wasn’t much to offer them at all. And I’m glad that perhaps we’ve been the ones who really sparked interest in treating this group. So that that itself is a good thing. You are correct this really is a completely different mechanism of action. The drug that you’re describing is of cortisol synthesis inhibitor. So it basically lowers the level of cortisol generally.

It’s a very different mechanism than Korlym of any of our follow-on compounds, which modulate activity at the end point – at the receptor. And I guess the – maybe an analogy to drop them is basically that cortisol synthesis inhibitor sort of lowers the water in the pool in a very leveling way, whereas a cortisol receptor antagonist allows for the normal diurnal variation to take place. And really in some sense causes a different qualitative result, I think in the group of patients.

But I’m very anxious to see everyone else’s data as it comes out. I think that we’re – we think mechanistically we have something which is really very special and I think one of the things that’s exciting about this call is that CORT125134 once before having now passed through Phase 1, and entering Phase 2 as an opportunity to really show the same mechanism. And potentially actually take away one of the side effects of Korlym that has kept probably certain patients from using it.

Christopher James

Great. Thanks for the color on that. And then my last question with respect to the pipeline, I think you mentioned data at ASCO. Do you expect to present PFS data by mid-year and or will this be objective response data only? And then maybe sort of comment on your view of the necessary bar on PFS in metastatic triple-negative breast from your, I guess understanding of historical data.

Joseph Belanoff

So Chris, the first and most important thing I can tell you is that we’ll present all the data we candid ASCO. So it’s our expectation that this study is going to be over about mid-year and I don’t know exactly when that’s going to be, but if it’s not at ASCO it will be soon after and we’ll present all that we can.

Now you’re hitting on something which is very important and glad to inform, excuse me, the whole group, which is that the feedback we’ve received from the regulatory agencies is that progression free survival is the end point they would want to see for pivotal study for approval. And we of course are keeping track of that as we’re going along. And as you know in the ASCO poster, while patients were still active it was something that we would measure.

We don’t know exactly what the bar for improvement in progression free survival is going to be. Unfortunately, for this disease progression free survival is slight and it’s really, it’s very unfortunate very is a dire illness and frankly we feel like every month the progression free survival is really a month very close to overall survival, because for many of these patients unfortunately the next place after our trial is hospice care.

So I don’t know exactly where that’s going to be. I would actually make sure everyone understands that in the end we’re going to have to do a trial, which measures standard therapy plus our medicine versus standard therapy that’s really going to be the acid test of whether we’re filling an improvement. We feel optimistic about moving to a trial like that but we really have to analyze all our results that we’re currently going to see before we make the decisions that exactly what’s going to happen after that.

Operator

Our next question is from Boris Peaker from Cowen. Please go ahead.

Boris Peaker

Good evening and I want to add my congratulations to the excellent results.

Joseph Belanoff

Thank you, Boris. And it’s good to hear from you.

Boris Peaker

So, I just want to follow-up more on Chris’s question in terms of breast cancer study. So…

Joseph Belanoff

Yes.

Boris Peaker

Particularly where these patients selected for GR receptors and was there any kind of correlation of response, correlation with any response in GR receptor expression?

Joseph Belanoff

So, I just want to – I know you have some of the background, but I just want to give it for the whole group. In the original University of Chicago study, they took patients who had tumors with GR-positive and some whose were not. And the responders in their small study, clearly showed that the GR-positive patients were the responders, they had longer progression-free survival and greater objective response and so forth. In our current study, I can tell you that all of our patients are in fact GR-positive.

Boris Peaker

Got you. And is there a correlation, I mean if there are different levels of GR expression that that you could look at correlation to efficacy or is it just kind of binary yes or no?

Joseph Belanoff

We’re starting with the binary criteria of greater than 10% of the tumors have to be GR-positive, but you’re asking an oppression question, that data we will look at as we get results from the study. I don’t have the results for it yet. I can tell you that in the University of Chicago study, there was a patient for instance, who was less than 10%, who was non-responder, and the greatest responders were across the board. They did not necessarily have the highest degree of GR density.

Boris Peaker

Got you. And when looking at the solid tumors that you plan to pursue with your second generation also, I guess.

Joseph Belanoff

Yes.

Boris Peaker

Are you also going to be screening for GR receptors as enrollment criteria, there is just going to be kind of – at the end of going forward?

Joseph Belanoff

Initially, I think in the dose-finding question we will take all covers, but observe what the GR status is. I think, it going forward it’s highly likely that we will use GR positivity as a criteria, but keep in mind one thing, which is really interesting and we’ve now published is that, there wasn’t much of the scientific literature about GR positivity in triple negative breast cancer before we really began to examine the disease. And in the literature, it was estimated that maybe 25% to 30% of the tumors were in fact GR-positive. We’ve now done by far the largest tumor event screening, and the GR positivity rate is much higher than that. Certainly about 80% and I can tell you in our clinical trials so far, I think it’s 100%.

So this is, for triple negative breast cancer at least, it looks as if it sort of matches up. For other cancers I do think that you GR positivity is going to be an entry criteria.

Boris Peaker

And in general, in these cancer patients, is cortisol level consistent with a healthy patient or do they have aberration in cortisol level as well?

Joseph Belanoff

There is a nice literature around this, and the answer is they tend to be higher and they tend to use their diurnal rhythm and if they lose their diurnal rhythm, their outcome is worse.

Boris Peaker

Got you. Okay. Well, thank you very much for the details and we look forward to the additional…

Joseph Belanoff

Yes. And glad to speak with you Boris. Please keep us in mind with any other questions.

Boris Peaker

Sure.

Operator

Our next question is from Alan Leon from Senior Analyst. Please go ahead.

Alan Leon

Thank you very much. Good to hear from you guys.

Joseph Belanoff

Hi, Alan.

Alan Leon

I have two sets of questions. But there was an earlier question asked about the prostate cancer trials the University of Chicago. I wonder if you could do the same, except but, if you have any commentary on the breast and ovarian cancer trial as well, as there is a non- University of Chicago trial with lung cancer as I understand it. Comment on what are the milestones, but also the importance of these trials, clinical program?

Bob Fishman

Yes. So let me just sort that out for all the listeners. I think really a unique thing about Corcept is that really from the beginning we thought the academic collaborations were very, very important part of our plan. Sort of Joseph said at the beginning, we really had a lot more ideas than money. But we really wanted to keep our research going and so we extensively collaborated over a period of the year I said at any given point in time, we probably have 30 different academic collaborations going on in the United States and abroad.

And it really stands a very nice, how to use a sport analogy form system for the kind of programs we want to eventually bring in-house. Now at University of Chicago, now to your question, there are more than one oncology study going on with the mifepristone with Korlym. One is in castration-resistant prostate cancer, another one is in triple-negative breast cancer and ovarian cancer and in some – in similar places they’ve enrolled a fair number of patients at this point, they’re not complete.

But I guess the progress report every week and progress is being made. So I can’t give you a specific read-out data at this point, but I can tell you these are passionate investigators who’ve actually originated the science and I know that they’re interested in putting out the results as soon as they feel like they have gel. The last point you made was about non-small cell lung cancer, yes in the last, if I guess, a month. A trial has opened with that disease, at a site in Philadelphia it’s an interesting trial, because this investigators actually using the drug as monotherapy, it’s published on this before and we’ll see what is results are. But I know at least the first patient has entered that study.

Alan Leon

I have a philosophical question seriously; even Charlie, just trying to [indiscernible] and you have this wonderful IP that applies on number of different indications. And if I look at 2016, I know in 2017, a lot of playing cards get turned over. So I wonder if you can provide a kind of commentary or some color on – on one hand, they’re living within their needs, on the other hand even within camps you have a number of directions you can afford to have.

Joseph Belanoff

Yes, and I think you raise an interesting question, which is we have – we’re very pleased that Sean and Dave run a great commercial business. It really at this point is funding everything that we do. And we’re budgeted for all the things that we described, it is possible that a significant positive result would want – could cause us to or want to expand what we’re currently doing. And that would be a nice moment to have to deal with. We’ll just have to – as you said, a lot of cards gets turned over in the next 12 months to 18 months, we’ll have to see where we are we’re feeling more and more confident that the scientific underpinnings for this area are growing and are strong. I don’t know where they’re going emerge as positive and net results for us to take forward. But we have many possibilities.

Alan Leon

Well, thanks. I look forward to seeing you soon.

Joseph Belanoff

Good Alan, thank you.

Operator

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

Roy Buchanan

Hi guys, just a couple of quick follow-up. I have a question on future combo studies if you had any plans with Abraxane or checkpoint inhibitors if you comment on that.

Joseph Belanoff

Bob, would you like to handle that question?

Bob Fishman

Sure. First on the topic of checkpoint inhibitors, for sure that’s an area of great interest to us and we can tell you that it’s an active research program. And in fact our research colleagues have completed the original study of tolerability in animals. And so now we move on to actual studies of the tumor, so that’s an exciting update. In terms of Abraxane, yes, we are considering other possibilities, we noted as a – I’m sure you have the approval just today in liposarcoma. We had been thinking about sarcoma. So, yes, we don’t have the final list, but are considering additional tumors as possibilities for investigation.

Joseph Belanoff

Yes. And just let me elaborate one thing. Roy, of course checkpoint inhibitors had been for good reason in the press a great deal. Checkpoint inhibitors are a form of immunomodulation and promising, very nice results. GR antagonist is sort of a core immunomodulation, it’s your natural immune system, I think. And you know there’s scientific reason to think that in combination this could be an effective strategy. Now the data will tell us what the data is going to tell us, but I just want to amplify what Bob said, this is something we’ve thought about for a while. The first animal study is now complete. And we’re hoping by the next time we have a conference call, we’ll have early animal data to share with you.

Roy Buchanan

Great, okay, thanks. And then I had a question about, could you guys were completing a ketoconazole interaction study, has that done? And is there any reason…

Joseph Belanoff

It is done. Yes.

Roy Buchanan

Okay. Is there any reason physicians couldn’t combine Korlym with ketoconazole and are you getting any – are they doing that?

Joseph Belanoff

The answer to that question is there really is no reason to combine the two treatments and its important kind of medical explanation. There’s really no amount of cortisol activity, which can’t be modulated by Korlym and I can tell you the dose is very great deal. There are people with more modest Cushing’s syndrome, no Cushing’s syndrome is good, who require a lower dose; and people with more severe Cushing’s syndrome, which require a much higher dose. And all of those forms of the disease can be modulated with Korlym. So there really is no additive value of using the drug like ketoconazole with Korlym. And the answer to your second question is no. No, we are not seeing people use them together.

Roy Buchanan

Okay, great. Thank you, guys.

Joseph Belanoff

Okay. Well, thank you very much everybody and really 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.

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