Corcept Therapeutics Incorporated (CORT) Q2 2021 Earnings Call Transcript

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Corcept Therapeutics Incorporated (CORT -1.48%)
Q2 2021 Earnings Call
Jul 29, 2021, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, thank you for standing by and welcome to the Corcept Therapeutics Conference Call. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question-and-answer session. [Operator Instructions]

I'd now like to hand the conference over to your speaker today Mr. Atabak Mokari. The floor is yours.

Atabak Mokari -- Chief Financial Officer

Thank you. Good afternoon and thank you for joining us. I'm Atabak Mokari, Corcept's Chief Financial Officer. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. The copy is available at corcept.com. Our complete financial results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available on the Investors past events tab of our website.

Statements during this call other than statements of historical fact are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include but are not limited to our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs.

The availability of competing treatments including generic versions of Korlym, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, and the risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversights and other requirements, and the impact of the COVID 19 pandemic on our employees, consultants and vendors as well as on physicians, patients, insurers, regulators and the practice of medicine general. These and other risks are set forth in our SEC filings which are available at our website and the SEC's website.

On this call forward-looking statements include those concerning the safety, efficacy and other clinical and commercial attributes of relacorilant, exicorilant, miricorilant, CORT113176, and our other selective cortisol modulators for the treatment of patients with solid tumors, liver disease, hypercortisolism, anti-psychotic-induced weight gain, amyotrophic lateral sclerosis or ALS, and other disorders; the progress, enrollment, timing, design, and results of our clinical trials; our revenue guidance, cash flow and expected growth; our stock repurchase program and its intended funding sources; the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers and patients and expectations regarding our financial performance in clinical development program after the COVID-19 pandemic is controlled; the timing, costs, and outcome of litigation, including our lawsuits against Teva, and Hikma Pharmaceuticals have us appeal of its defeat in the post-grant review brought before the Patent Trial and Appeals Board known as PATB, and our settlement of litigation with Sun Pharmaceuticals as well as the scope and protective power of our intellectual property and the benefits of orphan drug designation. We disclaim any intention or duty to update forward-looking statements.

Our revenue in the second quarter was $91.6 million, compared to $88.6 million in the second quarter of 2020 and $79.4 million in the first quarter of 2021. Second quarter 2021 GAAP net income was $26.5 million, compared to $28.3 million in the same period last year.

Excluding non-cash expenses related to stock-based compensation and utilization of deferred tax assets, together with related income tax effects, non GAAP net income in the second quarter was $38.2 million, compared to $39.7 million in the second quarter of 2020. We have reiterated our revenue guidance of $355 million to $385 million, which assumes the pandemic related restrictions will continue to ease in the second half of this year. Our cash and investments totaled $471.6 million at June 30, an increase of $16.8 million from March 31. In the second quarter of this year, we repurchased 1.5 million shares of our common stock, 1.4 million shares pursuant to our stock repurchase program, and about 150,000 shares in connection with the net exercise of employee stock options. The total cost of these repurchases was $30.8 million. Under the current terms of our stock repurchase program, $127.6 million remain available for the repurchase of shares. We will determine the timing and size of future repurchases if any based on market conditions, our stock price and other factors.

And now, Charlie Robb, our Chief Business Officer will provide the legal update. Charlie?

Charlie Robb -- Chief Business Officer

Thanks, Atabak. I'll briefly review our litigation against generic manufacturers Teva, Hikma and Sun Pharmaceuticals. In March 2018, we sued Teva in Federal District Court to prevent it from marketing a generic version of Portland in violation of our patents. Originally trial was set to start in February of this year. Last quarter, the court vacated this date in order for the parties to be ready for trial in March. That trial ready date was also vacated. A new trial date has not been set.

In April, we asked the court's permission to file for summary judgment based on Teva's alleged infringement of our 214 pack. The court granted permission and Teva responded by filing some summary judgment motion with respect to the same patent.

Summary judgment is a procedure whereby courts can decide the case without holding a trial. We believe that believe the court has all it needs with respect to the Q1 core patents and decide the case in our favor. Having lots of action before the PTAB, so we can no longer challenge the 214 patents validity in the district court case. So we can only argue that this proposed product will not infringe, position we believe has no legal or factual support.

We've been in this matters complete. We await the court's decision. The court grants our motion, we will have won the case. Teva would be barred from marketing generic core elements, so 2037 and a 214 patent expires target appeal of course, although the district courts bar would remain in place until the appeal is resolved, process that usually takes 12 to 18 months.

The court rules in Teva's favor, we will proceed to trial late this year sometime next year. There is a private no timetable for the court semi judgment, no trial date, and no schedule for any trial related activities. In parallel with a district court action, Teva has an expected petition the Federal Circuit Court of Appeals to reverse its PTAB loss. Briefing in this matter is also complete. Federal Circuit's Decision is likely in the first or second quarter of 2022.

Earlier this year, we received notice of another hand defiler, Hikma Pharmaceuticals. On March 12, we do take Hikma in the same Federal District Court that is the adjudicating our case against Teva. The court has entered the schedule for the case that sets a fact discovery deadline of July 1, 2022 next year.

Finally, Sun Pharmaceutical is also seeking to market generic court. In June 2019, we sued Sun to prevent it from doing so. As we announced a few weeks ago, we have settled this case. The settlement agreement allows Sun to begin selling a generic version of coral and beginning October 1, 2030 for more than 14 years from now or earlier, under circumstances are customary for settlements of this type.

I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Joseph Belanoff -- Chief Executive Officer

Thank you, Charlie. We are pleased with our commercial results in the second quarter. Pandemic related restrictions made it very difficult for our business to grow because those restrictions made it hard for physicians to provide patients to receive optimal care. Diagnosing and treating patients with a complex disease such as Cushing syndrome, requires frequent in person contact. For much of the pandemic. This level of contact was for many patients and physicians impossible. We are encouraged that in the second quarter, particularly at the end of the quarter, our commercial activity increased notably throughout the country with indication, countries opening more broadly, it is also heartening to patients recently introduced to Korlym, accrued toward their ideal dose more quickly than occurred in the last year, as many physicians are now seeing and testing their patients for the pre pandemic frequency.

Looking beyond this year, we expect that our Korlym business will continue to grow. Leading endocrinologist increasingly believe that there are many more patients with hypercortisolism than was once believed. Korlym is an excellent treatment for many of these patients. The foundation of our business and effective life saving medication, promoted by a dedicated commercial team that puts the interests of patients first remains rock solid.

We're also excited by the potential of our clinical development program, which have recently made important advances. From the beginning our research and development efforts have built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders. Korlym's commercial success is provided and will continue to provide the funds needed to enlarge our portfolio of proprietary selected cortisol modulators and to develop the most promising, many of these selected cortisol modulators are attractive candidates for development. Like Korlym, they bind strongly to the glucocorticoid receptor or GR, unlike Korlym, they have no affinity for the progesterone receptor and so don't cause some of the Korlym most serious off target effects.

Beyond sharing the qualities of strong cortisol modulation and not perturbing the progesterone receptor, preclinical and clinical testing have shown that our molecules behave differently from one another in important ways. Some cross the blood brain barrier, others do not. Some perform best in models of solid tumors others are more potent in models of metabolic disease. Some appear to be tissue specific, while others have more systemic effects. Their diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders, including ovarian, adrenal and prostate cancer, anti-psychotic induced weight gain and nonalcoholic steatohepatitis or NASH and of course Cushing syndrome.

We are now planning a Phase II trial in patients with ALS another devastating disease with no particularly effective treatment options and we have additional compounds in Phase I and the latter stages of preclinical development. Our oncology program is testing three mechanisms; first postulated by investigators at the University of Chicago and confirmed by other prominent researchers. One mechanism is increasing apoptosis. Apoptosis is the program to cell death, chemotherapy is meant to induce. Cortisol suppresses apoptosis and are successful trial in women with advanced ovarian cancer addition of the selected cortisol modulator or Korlym enhance the effect of chemotherapy by blending cortisol antipsychotics effect. Based on statistically significant and clinically meaningful Phase II result we are excited to initiate a Phase III pivotal trial in patients with Platinum resistant ovarian cancer in the first quarter of 2022.

As a reminder, our Phase II trial is a controlled multicenter study of 178 women with Platinum resistant ovarian cancer who are randomized to one of three treatment arms. In addition to nab-paclitaxel, 60 women received 150 milligrams of relacorilant intermittently, meaning they received relacorilant on the day before, the day and the day after they receive nab-paclitaxel. And 58 women received a lower daily relacorilant dose of 100 milligrams per day, 60 women received nab-paclitaxel alone. The trial's primary endpoint was progression-free survival or PFS.

The women who participated in our study were very ill. All had experienced disease progression despite prior lines of therapy. The median number of prior treatments was three. It is clear that relacorilant benefited many of these women. Those who received relacorilant intermittently exhibited a statistically significant improvement in PFS compared to the group that received nab-paclitaxel monotherapy. Their hazard ratio was 0.66 with a p-value of 0.038. Their median PFS was 5.6 months, 1.8 months longer than the nab-paclitaxel monotherapies group, which is 3.8 months.

Safety and tolerability data for the two groups were comparable. The woman who received a lower dose of relacorilant everyday also saw their disease progressed more slowly. Their median PFS was 1.5 months longer than nab-paclitaxel model therapy group. Their hazard ratio was 0.83 although this result was not statistically significant. We believe and more importantly, our investigators believe that these results a 1.8 month increase in PFS without any increase in side effects are clinically meaningful. We are honored that our Phase 2 trial results have been accepted for a proper paper oral presentation at the European Society for Medical Oncology ESMO meeting in September in Paris. Finally, we anticipate that overall survival results from this study will be available later this year.

A second is a mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason patients treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease. Deprived of androgen stimulation, to private androgen stimulation their tumors switched to cortisol activity to stimulate growth. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. We are conducting a dose-finding study of our selective cortisol modulator exicorilant combined with enzalutamide in men with castration-resistant prostate cancer and expect to produce clarifying data next quarter.

Our third oncologic mechanism recognizes cortisol ability to reduce inflammation and suppress the immune system that's that are often beneficial in healthy people. But in patients with solid tumors diminish the effectiveness of immunotherapy. We are conducting an open label Phase 1b trial of relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab makes Merck's drug, Keytruda in patients with advanced adrenal cancer whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and Cushing's syndrome, a usually quickly lethal combination. Pembrolizumab is rarely effective as monotherapy in these patients. We believe that these patients cortisol excess may be counteracting the intended effects of pembrolizumab which is to stimulate the immune system.

Our trial is evaluating with the relacorilant and treat these patients' Cushing's syndrome by reducing excess cortisol activity and by reversing cortisol-induced immune suppression, also allow pembrolizumab to achieve its full cancer-killing effect. We plan to enroll 20 patients at five sites in the United States. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival, duration of response and overall survival.

I will now turn to our program in metabolic diseases and the recent findings with our proprietary selective cortisol modulator, miricorilant in patients with NASH, a serious liver disorder.

We asserted that patients who receive miricorilant in our Phase 2a trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of the liver enzymes, ALP and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected. Reductions in liver fat of the magnitude that we observed in our study are rarely seen over any period of treatment.

As a reminder, we had powered the trial can detect a 30% reduction after 12 weeks of treatment. The patients in our study exhibited reductions ranging from 39% to 74% after receiving miricorilant for just a month. It may be that the rapidity of miricorilant's fat reducing effect caused ALP and AST to rise. One way the liver shifts back is by metabolizing it into fatty acid, which in excessive amounts irritates the liver.

Interestingly, levels of serum lipids in these patients did not increase with treatment, providing further support for the metabolism hypothesis. Our upcoming Phase 1b dose finding trial in patients with presumed NASH will evaluate if they're introducing regime of miricorilant and can produce such significant reductions in liver fat without causing liver irritation.

We're also evaluating miricorilant as a potential treatment for patients with another serious and widespread disorder, anti-psychotic induced waking. In the United States, 6 million people take anti-psychotic medications such as olanzapine and risperidone to treat illnesses such as schizophrenia, bipolar disorder, and depression. While these drugs are very effective, they exact steep price in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances.

Patients can gain a pound per week in the first 10 weeks that they take these medications and their life expectancy is decreased on average by 20 years, due in part to increased cardiovascular events, such as heart attacks and strokes.

We're conducting two double-blind placebo-controlled Phase 2 trials of miricorilant in patients with this disorder, GRATITUDE and GRATITUDE II. These trials seek to build on the positive data from our study of miricorilant in healthy subjects.

Last year we completed Phase 1b trial in which 96 healthy subjects received olanzapine and either 600 milligrams of miricorilant, 900 milligrams of miricorilant, or placebo for 14 days. Subjects who received miricorilant gained significantly less weight than those who received placebo. They also exhibited a smaller increase in triglycerides and in ALT and AST. A paper describing these results will be published in the Journal of Clinical Psychopharmacology this quarter.

The GRATITUDE trials evaluating whether miricorilant can reverse recent anti-psychotic induced weight gain. 100 patients with schizophrenia or bipolar disorder will receive in addition to their established dose of anti-psychotic medication, either 600 milligrams of miricorilant or placebo for 12 weeks. GRATITUDE is being conducted at 30 centers in the United States.

Our GRATITUDE II study is testing miricorilant as a treatment for long standing anti-psychotic induced weight gain. 150 patients with schizophrenia will receive in addition to their established dose of anti-psychotic medication, either 600 milligrams or 900 milligrams of miricorilant or placebo for 26 weeks. GRATITUDE II is being conducted at 35 centers in the United States.

The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be examined. We expect to complete enrollment in GRATITUDE II by the end of this year and in GRATITUDE in mid-2022.

As most of you know, relacorilant is our planned successor to Korlym for the treatment of hypercortisolism. We are evaluating in two Phase 3 GRACE and GRADIENT.

To repeat what I said earlier, relacorilant is a selective cortisol modulator, like Korlym, it achieves its effects by competing with cortisol at the glucocorticoid receptor. Unlike Korlym, it does not bind to the progesterone receptor, PR for short. It is not the abortion pill and it does not cause other PR-related side effects, including endometrial thickening and vaginal bleeding. By a different mechanism, relacorilant also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym's pivotal trial.

Korlym-induced hypokalemia is a leading cause of Korlym discontinuation. Our GRACE trial has a planned enrollment of 130 patients with any etiology of Cushing's syndrome at sites in the United States, Canada, Europe and Israel.

Relacorilant's Phase 2 efficacy and safety data was strong. The trial results were recently published in frontiers in endocrinology. Patients experienced meaningful improvements in hypertension and glucose control as well as in a variety of other signs and symptoms of Cushing's syndrome. There were no relacorilant induced instances of endometrial thickening or vaginal bleeding and no drug-induced hypokalemia. We and our investigators are eager to take GRACE to the finish line. We expect GRACE to serve as the basis for our NDA submission in Cushing's syndrome which we remain on track to submit in the second quarter of 2023.

Our second Phase 3 trial GRADIENT, studying relacorilant's effects in patients whose Cushing's syndrome is caused by an adrenal adenomas or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome often experience a less rapid decline, but ultimately their health outcomes are poor. GRADIENT has a planned enrollment of 130 patients and is being conducted at many of the sites participating in GRACE. GRADIENT has a first controlled study, dedicated to patients with this type of Cushing's syndrome. While we do not expect our NDA in Cushing's syndrome to depend on data from GRADIENT, we do expect that its findings will help improve the care of these increasingly recognize patients.

Last, a brief update on our intellectual property position for relacorilant in Cushing syndrome. As you are likely aware, we hold the composition of matter patent for relacorilant that is valid to 2033. We were recently issued a method of use patents that we expect will be included in the orange book for relacorilant and should have received FDA approval, that is valid up to 2040.

Finally, a brief word about CORT113176 which has shown promising animal models of ALS. We're discussing with leading clinicians in the FDA regarding our development plans, and plan to initiate a Phase 2 trial by early next year. Our belief has always been the cortisol modulation can help treat many serious disorders. Korlym for patients with Cushing's syndrome is one very clear example. Promising data in our ovarian cancer and NASH programs provide increasing proof cortisol modulation's broad work.

While the pandemic dampened our commercial results for more than a year, we are confident that our business will resume its growth as conditions continue to improve. It is already growing. Even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.

Currently, our oncology program is evaluating two of our proprietary cortisol modulators in combination with three different anti-cancer agents in three tumor types. In addition, our metabolic program is conducting important initial trials and NASH and antipsychotic induced weight gain.

We also continue to enroll patients in our flagship Phase 3 trials of relacorilant in Cushing syndrome and will advance CORT113176 to treat patients with ALS by early next year. Meanwhile, additional proprietary early stage compounds advance toward the clinic.

The breadth of our program reflects the power of our fundamental scientific hypothesis. Cortisol modulation is a potent therapeutic modality. We have proven that in patients with Cushing's syndrome. We are now adding to the body of evidence that proves its worth for patients with other serious disorders.

I'll stop here for questions.

Questions and Answers:

Operator

[Operator Instructions] Your first question comes from the line of Alan Leong from BioWatch News. Your line is now open.

Alan Leong -- BioWatch News -- Analyst

-- my questions and congratulations on the quarter. But I want to send kudos especially to Sean for executing on the sales plan in a business environment that was under transition. So I don't know if he's there, but congratulations.

Sean Maduck -- Chief Commercial Officer

Thanks, Alan. Yes, this is Sean.

Alan Leong -- BioWatch News -- Analyst

This is a question, I guess, for anyone, you mentioned -- Joe, you mentioned about titrate -- titrating Korlym quickly. Are the physicians more willing to venture into a stronger dose than say, even a couple of years ago, or a little more?

Atabak Mokari -- Chief Financial Officer

Joe, you what to take that question.

Joseph Belanoff -- Chief Executive Officer

Yes. So just -- the question is, are physicians now more readily open to titration -- to titrating to a higher dose? Was that the question?

Alan Leong -- BioWatch News -- Analyst

Yes.

Joseph Belanoff -- Chief Executive Officer

And are you asking that specifically to, how it may be different than during the pandemic?

Alan Leong -- BioWatch News -- Analyst

Well, could be, but more really -- really, as the physician community, I would expect, having more experience or reading more literature and talking to their mates about their experience of Korlym may feel a little bit less reluctant to raise the dose to an optimal level.

Andreas Grauer -- Chief Medical Officer

Yes. I mean, I would say that you hit the nail on the head of that right there. I mean, physicians that have had more experienced with a compound are more comfortable using it, are more comfortable with the cadence of patient visits that are required to follow up, have definitely moved to titrate to higher dose and the most efficacious dose for that patient. Now, an important point is that, it really does vary patient by patient. This is patient dependent. Is there anything Joe, you want to add to that.

Joseph Belanoff -- Chief Executive Officer

Yes. I would. I think, Alan -- I think, really what you're getting at is, is the behavior different than it was several years ago. And the answer to that is right now, it really isn't at all. I think that's actually a real positive. It's a very interesting point, which is that we're now seeing patients titrate -- I'm sorry, physicians titrate their patients' doses at the same cadence that we saw pre-pandemic, not more than that, because at that point in time, you really were getting the patients their ideal dose.

The interesting thing -- and again, there were strange things in the pandemic in many areas, was that, because doctors could not see patients as frequently, seemed as if they were not on the same cadence of hydration. And so it's just heartening to see that they've returned to pre-pandemic behavior at this point. But overall, our average dose per patient is very similar to for now many years.

Alan Leong -- BioWatch News -- Analyst

I have one more question. It could be to Joe, and to Andreas. Regarding, the recent NASH results you had a rapid liver fat reduction, and a little bit of inflammatory markers going up? Did you really -- did you see any notable similar phenomenon or with other NASH drugs either in preclinical or in human trials done in the literature?

Andreas Grauer -- Chief Medical Officer

Well, if you're referring to like a transit increase of contaminates as in patients with NASH that are treated with drugs to reduce liver fat. Calories reports, and there are reports in the literature that. It is a known phenomenon. It's just the scale was different when we look at those, both the scale of the liver fat reduction and the scale of the transaminase elevation, what you often -- what been described with some of the other NASH compounds is an increase of ASG and ALS like 20%. And we have looked at a much bigger increase. But, but that's why we're going forward and trying to find our sweet spot where we achieve a good reduction in liver fat without affecting the liver, liver negatively on the way to do that.

Joseph Belanoff -- Chief Executive Officer

I mean, I think that's exactly right, Andreas, and I just want to add little color to that Alan, which is to say, you know, the question is has had this phenomenon been observed a simultaneous decrease in liver fat and increase in liver functions and the answer to that is yes. But, Andreas point is also an a second points also an important one. Never on scale, that we saw no one has seen the kind of rapid fat decrease in their studies. And, and at the same time, the liver elevation and liver function test, which normalized as soon as the drug was withdrawn. No one's ever seen that either. And so, really take Andres, conclusion as it is, what we're really looking through is that we can really harness this extreme activity without irritating the liver. That's really the goal. And that's what the next study, who were looking for the ideal dosing regimen is going to address.

Alan Leong -- BioWatch News -- Analyst

Thanks for taking my question. It looks like a pretty interesting next 12 months.

Joseph Belanoff -- Chief Executive Officer

Thank you, Alan.

Andreas Grauer -- Chief Medical Officer

Thanks, Alan.

Operator

Your next question comes from the line of Matt Kaplan from Ladenburg Thalmann.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Hi, good afternoon guys and that's for taking the questions. Just wanted to know, first, congrats on the strength of the quarter. Nice -- nice rebound and the revenues Korlym. So dig into your pipeline a little bit. Can you I guess first, give us a an update in terms of the pace of enrollment and how enrollment is going with the relevant Phase 3 gradient study in Phase 3 gradient study in Cushing's syndrome?

Joseph Belanoff -- Chief Executive Officer

Yes. I mean, as I said, Matt, in my remarks, we have not changed the timeline at all. It's just as it was before, and the only caveat I would add to that is, it's-we're in an uncertain time in the world. We see no need at the moment to make any alterations. Things certainly are better than they were a year ago. But we'll just have to see what happens. So I just would refer you to that the timelines are unchanged.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay. Okay. That's helpful. And then I guess you're on track to the start your Phase 3 study in ovarian cancer in the first quarter of next year. Can you give us a little color in terms of what that study will look like in terms of design and endpoints and stuff like that?

Joseph Belanoff -- Chief Executive Officer

Yes. Let me just turn that question over to Andreas.

Andreas Grauer -- Chief Medical Officer

So we are finalizing some of those questions. And obviously, many of them are important. And I think there are a few things that are clear. One is to those that are the regimen that we're going to test is the intermittent regimen of relacorilant plus nab-paclitaxel.

The comparator, we're favoring currently a physician's choice comparator, so we would give, like a dealer's choice, we would give physician the choice of a single, a single agent chemotherapy in these platinum resistant or refractory patients. And the primary endpoint I think are even going vision is overall survival is going to be required as a primary endpoint for approval. But we're having a lot of conversations with high level opinion leaders and will obviously eventually pretty soon have conversations with the regulators to form those assumptions.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Okay, that's helpful. And then I guess, lastly, in terms of the work you're doing with your miricorilant, and metabolic diseases, specifically anti-psychotic-induced weight gain, how are those studies progressing now? And when can we -- when can we expect them to meet out the most?

Andreas Grauer -- Chief Medical Officer

Yes, I mean, you've sure you've read what we shared in the press release, right. But we still want to complete enrollment in the GRATITUDE II study by year-end and mutual GRATITUDE study by mid-2022. We're on track for that. And, obviously, we'll have to flip the cards over and see what we see what we observe in these trials. So we're quite excited about it and hope that we can demonstrate the treatment benefit.

Joseph Belanoff -- Chief Executive Officer

And then what I just add to that is, as you know, the pandemic create different pressures in different sorts of studies. At the moment, we're actually seeing things you know, progress quite a lot. I just, again, I just add what I said before, it's an uncertain world, but at this moment in time, we really are fine with what we're seeing and as we said, we've repeated our timeline.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

And just a follow-up on that in terms of your sense in terms of moving what you need to see from an impact point of view on the weight gain and the unmet need, I guess, in this patient population. And where miricorilant could play a role there?

Joseph Belanoff -- Chief Executive Officer

Well, let me address this one. Because, you know, Matt as you know, these are my patients. I mean, as a psychiatrist -- every psychiatrist prescribed these medications. They're very effective for what they're intended to treat, which is psychosis, we're as adjuncts to handling depressants in major depression or bipolar disorder. So from an advocacy point of view, they're, they're very good. Unfortunately, they have this terrible metabolic [indecipherable] which is that they really perturb that system, they cause weight gain and even though I didn't mention it in my remarks, that's actually a problem for treatment adherence, people don't like how they look, they don't like how they feel. And if they are disciplined enough to stay on the medications, ultimately, they develop a lot of the diseases we see with 10% or 15% weighting or sometimes more than that. So there's no doubt among physicians who treat these patients that there's a great need for something to do with this problem.

And so, we -- again, I sort of look at -- both halves here, as a trader of these patients, some in developing medications for them, I really believe that if you could come up with something which would help those issues, it would be very, very meaningful and a large market with a lot of suffering. And we'll just have to see, I mean, studies are set up to demonstrate for a week change. And I think, importantly, to metabolic perturbations that come with that in which change is good. But it would be much better if you could actually develop something which helps with some of the other problems, like things like increasing triglycerides or fasting insulin things which make people less prone to diabetes.

So thanks for giving me an opportunity to expand in some ways. This is a mental illness as a whole, has a lot of stigma and is talked about within it. This is a big, big problem and we can do something about it.

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Thanks Charlie. That's helpful, put into context. Thanks for taking questions.

Charlie Robb -- Chief Business Officer

Sure.

Operator

Your last question comes from the line of Arthur He from H.C. Wainwright. Your line is now open.

Arthur He -- H.C. Wainwright -- Analyst

Good afternoon, everyone. This is Arthur He for RK [Phonetic]. Thank you for taking my question. Most of my question being answered. So I'm just curious, beside the share buy program has the management discussed any other plan to further improve the shareholder value?

Atabak Mokari -- Chief Financial Officer

We discuss it continuously in our plan. No, and look the most important thing we can do to increase shareholder value is for our program to succeed in our commercial program to continue on the path that is there. Other ancillary things we really do review our board is very conscious of things like that. We feel that our stock is at an inexpensive price right now, as you know, we're committing our own funds to it and we will continue to do that. But beyond that, when we have something more specific, Arthur will talk about it.

Arthur He -- H.C. Wainwright -- Analyst

Thank you. Thank you for that and congratulations on the strong quarter.

Atabak Mokari -- Chief Financial Officer

Thank you very much. And I want to just thank everyone else for listening in. I'm sure it's a hot summer afternoon, wherever you are. So stay cool and healthy and we'll talk to you next quarter.

Operator

[Operator Closing Remarks]

Duration: 39 minutes

Call participants:

Atabak Mokari -- Chief Financial Officer

Charlie Robb -- Chief Business Officer

Joseph Belanoff -- Chief Executive Officer

Sean Maduck -- Chief Commercial Officer

Andreas Grauer -- Chief Medical Officer

Alan Leong -- BioWatch News -- Analyst

Matt Kaplan -- Ladenburg Thalmann -- Analyst

Arthur He -- H.C. Wainwright -- Analyst

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