Corcept Therapeutics - Earnings Call - Q2 2021

Transcript

Speaker 0

Good day. Thank you for standing by, and welcome to Corcept Therapeutics Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Thank you.

I would now like to hand the conference over to your speaker today, Mr. Atabak Makari. The floor is yours.

Speaker 1

Thank you. Good afternoon, and thank you for joining us. I'm Atabak Makari, Corcept's Chief Financial Officer. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. A copy of it 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 expressed or implied. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-nineteen 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 our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym, 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-nineteen pandemic on our employees, consultants and vendors as well as on our physicians, patients, insurers, regulators and the practice of medicine generally. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's Web 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, antipsychotic 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-nineteen pandemic on our commercial operations, financial performance, clinical development programs physicians, payers and patients and expectations regarding our financial performance and clinical development programs after the COVID-nineteen pandemic is controlled. The timing, cost and outcome of the litigation, including our lawsuits against Teva and Hikma Pharmaceuticals, Teva's appeal of its defeat in the post grant review I brought before the Patent for Allent Appeals Board known as PTAB 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 $91,600,000 compared to $88,600,000 in the 2020 and $79,400,000 in the 2021. Second quarter twenty twenty one GAAP net income was $26,500,000 compared to $28,300,000 in the same period last year. Excluding non cash expenses related stock based compensation and the utilization of deferred tax assets together with related income tax effects, non GAAP net income in the second quarter was $38,200,000 compared to $39,700,000 in the '20. We have reiterated our revenue guidance of $355,000,000 to $385,000,000 which assumes that pandemic related restrictions will continue to ease in the second half of this year.

Our cash and investments totaled $471,600,000 at June 30, an increase of $16,800,000 from March 31. In the second quarter of this year, we repurchased 1,500,000.0 shares of our common stock, 1,400,000.0 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 $30,800,000 Under the current terms of our stock repurchase program, 127,600,000.0 remains 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 a legal update.

Charlie?

Speaker 2

Thanks, Atabak. I'll briefly review our litigation against generic manufacturers, Teva, Ikma and Sun Pharmaceuticals. In March 2018, we sued Teva in Federal District Court to prevent it from marketing a generic version of Korlym in violation of our patents. Originally, trial was set to start in February. Last quarter, the court vacated this date in order for 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 two fourteen patent. The court granted permission, and Teva responded by filing its own summary judgment motion with respect to the same patent. Summary judgment is a procedure whereby courts can decide a case without holding a trial.

We believe the court has all it needs with respect to the two fourteen patent to decide the case in our favor. Having lost its action before the PTAB, can no longer challenge the two fourteen patent's validity in the district court case. Teva can only argue that its product this proposed product would not infringe, a position we believe has no legal or factual support. Briefing in this matter is complete. We await the court's decision.

If the court grants our motion, we will have won the case. Teva would be barred from marketing generic Korlym until 2037 when the 02/14 patent expires. Teva could appeal, of course, although the district court's bar would remain in place until the appeal is resolved, process that usually takes twelve to eighteen months. The court ruled in Teva's favor, we will proceed to trial late this year or sometime next year. There is at present no timetable for the court summary judgment ruling, no trial date and no schedule for any trial related activities.

In parallel with the District Court action, Teva has as expected petitioned the Federal Circuit Court of Appeals to reverse its PTAB loss. Briefing in this matter is also complete. Federal Circuit decision is likely in the 2022. Earlier this year, we received notice of another ANDA filer, Hikma Pharmaceuticals. On March 12, we sued Hikma in the same Federal District Court that is adjudicating our case against Teva.

The court has entered a schedule for the case that sets a fact discovery deadline of 07/01/2022, next year. Finally, Sun Pharmaceuticals is also seeking to market generic Korlym. 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 Korlym beginning 10/01/2034, more than fourteen years from now, or earlier under circumstances customary for settlements of this type.

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

Speaker 3

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 and patients to receive optimal care. Diagnosing and treating patients with a complex disease such as Cushing's 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, clear indications that the country is opening more broadly. It is also heartening that patients recently introduced to Korlym have titrated towards their ideal dose more quickly than occurred in the last year as many physicians are now seeing and testing their patients with pre pandemic frequency. Looking beyond this year, we expect that our Korlym business will continue to grow. Leading endocrinologists increasingly believe that there are many more patients with hyper cortisolism than was once believed. Korlym is an excellent treatment for many of these patients.

The foundation of our business, an effective life saving medication promoted by a dedicated commercial team that puts the interest of patients first remains rock solid. We are also excited by the potential of our clinical development programs, which have recently made important advances. From the beginning, our research and development efforts have built on the hypothesis that cortisol modulation a powerful therapeutic mechanism in many serious disorders. Korlym's commercial success has provided and will continue to provide the funds needed to enlarge our portfolio of proprietary selective cortisol modulators and to develop

Speaker 0

excited the the are about potential made

Speaker 3

receptor and so don't cause some of the Korlym's 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 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, antipsychotic induced weight gain and nonalcoholic steatohepatitis, or NASH, and, of course, Cushing's 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 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 programmed cell death chemotherapy is meant to induce. Cortisol suppresses apoptosis. In our successful trial in women with advanced ovarian cancer, addition of the selective cortisol modulator relacorilant enhanced the effect of chemotherapy by blunting cortisol's anti apoptotic effect. Based on statistically significant and clinically meaningful Phase II results, we are excited to initiate a Phase III pivotal trial in patients with platinum resistant ovarian cancer in the 2022. As a reminder, our Phase II trial is a controlled multicenter study of one hundred and seventy eight women with platinum resistant ovarian cancer who were randomized to one of three treatment arms.

In addition to NaPaquataxil, sixty women received one hundred and fifty milligrams of relacorilant intermittently, meaning they received relacorilant on the day before, the day of, and the day after they received nab paclitaxel. And fifty eight women received a lower daily relacorilant dose of one hundred milligrams per day. Sixty 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 five point six months, 1.8 longer than the nab paclitaxel monotherapy's group, which is three point eight months. Safety and tolerability data for the two groups were comparable. The women who received a lower dose of relacorilant every day also saw their disease progress more slowly. Their median PFS was one point five months longer than the paclitaxel monotherapy 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 one point eight month increase in PFS without an increase in side effects, are clinically meaningful. We are honored that our Phase II 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 the study will be available later this year. A second 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.

Deprivation of androgen stimulation I'm sorry, deprived of androgen stimulation, their tumors switch 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. A third oncologic mechanism recognizes cortisol's ability to reduce inflammation and suppress the immune system. Effects 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 Ib trial of relacorilant plus the PD-one checkpoint inhibitor pembrolizumab, 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 countering the intended effects of pembrolizumab, which is to stimulate system. Our trial is evaluating whether relacorilant can treat these patients' Cushing syndrome by reducing excess cortisol activity and by reversing cortisol induced immune suppression, 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 I'll now turn to our programs in metabolic disease and the recent findings of our proprietary selective cortisol modulator, miricorilant, in patients with NASH, a serious liver disorder. We observed that patients who received miricorilant in our Phase IIa trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of the liver enzymes ALT 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 have powered the trial to detect a 30% reduction after twelve weeks of treatment. The patients in our study exhibited reductions ranging from thirty nine percent to seventy four percent after receiving miricorilant for just a month. It may be that the rapidity of miricorilant's fat reducing effect caused ALT and AST to rise. One way the liver sheds fat is by metabolizing it into fatty acid, which in excessive amounts irritate 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 Ib dose finding trial in patients with presumed NASH will evaluate if there is a dosing regimen of miricorilant that 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, antipsychotic induced weight gain. In The United States, six million people take antipsychotic medications such as olanzapine and risperidone to treat illnesses such as schizophrenia, bipolar disorder and depression. While these drugs are very effective, they exact a 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 ten weeks that they take these medications, and their life expectancy is decreased on average by twenty years due in part to increased cardiovascular events such as heart attacks and strokes.

We are conducting two double blind placebo controlled Phase II 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 a Phase Ib trial in which 96 healthy subjects received olanzapine and either six hundred milligrams of miricorilant, nine hundred milligrams of miricorilant or placebo for fourteen 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 trial is evaluating whether miricorilant can reverse recent antipsychotic induced weight gain. One hundred patients with schizophrenia or bipolar disorder will receive, in addition to their established dose of antipsychotic medication, either six hundred milligrams of miricorilant or placebo for twelve weeks. GRATITUDE is being conducted at 30 centers in The United States. Our GRATITUDE II study is testing miricorilant as a treatment for longstanding antipsychotic induced weight gain.

One hundred and fifty patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either six hundred milligrams or nine hundred milligrams of miricorilant or placebo for twenty six 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-twenty twenty two.

As most of you know, relacorilant is our planned successor to Korlym for the treatment of hypercortisolism. We are evaluating it in two Phase III trials, RACE and GRADIENT. To repeat what I said earlier, relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect 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 forty four percent 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 II efficacy and safety data were 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 '23.

Our second Phase III trial, GRADIENT, is studying relacorilant's effects in patients whose Cushing syndrome is caused by an adrenal adenoma 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 GRADIENT. GRADIENT is the 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 upon data from GRADIENT, we do expect that its findings will help improve the care of these increasingly recognized patients.

Last, a brief update on our intellectual property position for relacorilant in Cushing syndrome. As you are likely aware, we hold a composition of matter patent for relacorilant that is valid to 02/1933. We were recently issued a method of use patent that we expect will be included in the orange book for relacorilant should it receive FDA approval that is valid to 02/1940. Finally, a brief word about CORT January seventy six, which has shown promise in animal models of ALS. We are in discussion with leading clinicians and the FDA regarding our development plans and plan to initiate a Phase II trial by early next year.

Our belief has always been that cortisol modulation can help treat many serious disorders. Korlym for patients with Cushing's syndrome is one very clear example. The promising data in our ovarian cancer and NASH programs provide increasing proof of cortisol modulation's broad worth. 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 anticancer agents in three tumor types. In addition, our metabolic program is conducting important initial trials in NASH and antipsychotic induced weight gain. We also continue to enroll patients in our flagship Phase III trials of corollant and Cushing syndrome, and will advance CORT113-one hundred seventy six to treat patients with ALS by early next year. Meanwhile, additional proprietary early stage compounds advance towards 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 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.

Speaker 0

Your first question comes from the line of Alan Wong from BioWatch News. Your line is now open.

Speaker 4

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.

Speaker 3

Thanks, Alan. Yes, that was Sean.

Speaker 4

So this is a question I guess for anyone. Mentioned Joe, you mentioned about 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?

Speaker 3

Sean, would you like to take that question?

Speaker 5

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

Speaker 4

Yes.

Speaker 5

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

Speaker 4

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

Speaker 5

Yes. I mean, would say you've hit the nail on the head with that right there. I mean, that have had more experience with a compound or more comfortable using it or more comfortable with the cadence of patient visits or that are required to follow-up, have definitely moved to titrate to a higher dose and the most efficacious dose for that patient. Now I think an important point is that it really does vary patient by patient. It's patient dependent.

Is there anything, Joe, you want to add

Speaker 3

to that? Yes. I think, Alan, I think really what you're getting at is 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, they really were getting to patients their ideal dose. The interesting thing, you know, and again, there were strange things in the pandemic in many areas, was that because doctors could not see patients as frequently, it seemed as if they were not on the same cadence of titration. 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 for now many years.

Speaker 4

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

Speaker 6

Well, what if you're referring to like a transit increase of transaminases in patients with NASH that are treated with drugs that reduce liver fat, there is 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's been described by some of the other NASH compounds is an increase of ASC and ALT of like 20%. And we had looked at a much bigger increase. 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 negatively on the way to that.

Speaker 3

I mean, think that's exactly right, Andreas. And I just want to add a little color to that, Alan, which is to say the question is has this phenomenon been observed of simultaneous decrease in liver fat and increase in liver function sets? The answer to that is yes. But Andreas' point is also the second point is also an important one. Never on the scale that we saw, no one has seen the kind of rapid fat decrease in their studies that we did.

And at the same time, the liver elevation in liver function test, which normalized as soon as the drug was withdrawn, no one's ever seen that either. And so, really, to take Andreas' conclusion as it is, what we're really looking to is if we can really harness this extreme activity without irritating the liver, that's really the goal. And that's what the next study we were looking for, the ideal dosing regimen is going to address.

Speaker 4

Thanks for taking my questions. It looks like a pretty interesting next twelve months.

Speaker 3

Yes. Thank you, Alan. Thanks,

Speaker 1

Alan. Your

Speaker 0

next question comes from the line of Matt Kaplan from Baird.

Speaker 7

Hi, good afternoon guys and thanks for taking the questions. Just wanted to first congrats on the strength of the quarter, nice rebound in the revenues Korlym. To dig into your pipeline a little bit, can you I guess first give us an update in terms of the pace of enrollment and how enrollment is going with the relacorilant Phase III GRADE study and Phase III gradient study in Cushing's syndrome?

Speaker 3

Yes. I mean, as I said, Matt, in my remarks, we have not changed the time line at all. It's just as it was before. And the only caveat I would add to that is 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.

Speaker 7

Okay. Okay. That's helpful. And then I guess you're on track to start your Phase III 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?

Speaker 3

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

Speaker 6

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 the dose that or the regimen that we're going to test is the intermittent regimen of, relacorilant with naphaclitaxel. The comparator, we're favoring currently a physician's choice comparator.

So we would give, like a dealer's choice, we would give a physician the choice of a single agent chemotherapy in these platinum resistant or refractory patients. And the primary endpoint, I think our ingoing position 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 we'll obviously eventually, pretty soon, have conversations with the regulators to firm those assumptions up.

Speaker 7

Okay. That's helpful. And then I guess lastly, in terms of the, work you're doing with miricorilant and metabolic diseases specifically, antipsychotic induced weight gain, how are those studies progressing now? And when we expect some readout

Speaker 1

from those?

Speaker 6

Yes. I mean, you've I'm sure you've read what we shared in the press release, right? But we we want to complete enrollment in the GRATITUDE II study by year end and in the initial GRATITUDE study by mid-twenty twenty two.

Speaker 4

We're on track,

Speaker 6

for that. And then obviously, we'll have to flip the cards over and see what we observe in these trials. So we're quite excited about it and, hope that we can demonstrate treatment benefit.

Speaker 3

And Matt, what I'd just add to that is, as you know, the pandemic created different, pressures in different sorts of studies. At the moment, we're actually seeing things progress right along. I just again, I'll 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 I said, we've repeated our time lines.

Speaker 7

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?

Speaker 3

Well, let me address this one because, Matt, as you know, these are my patients. I mean, as a every psychiatrist prescribes these medications, they're very effective for what they're intended to treat, which is psychosis or as adjuncts to antidepressants in major depression or bipolar disorder. So from an advocacy point of view, they're very good. Unfortunately, they have this terrible metabolic Achilles heel, 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 you see with 10% or 15% weight gain 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, again, I sort of look at wear both hats here. As a treater of these patients and someone 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. It's a large market with a lot of suffering. And we'll just have to see. I mean the studies are set up to demonstrate both weight change and I think importantly to metabolic perturbations that come with that.

Mean weight change is good, it but would be much better if you could actually develop something which helped with some of the other problems like things like increase in triglycerides or fasting insulin, things which make people less prone to diabetes. So thanks for giving me the opportunity to expand it some length. This is a mental illness as a whole has a lot of stigma and isn't talked about within it. This is a big, big problem and hoping we can do something about it.

Speaker 7

Thanks, Charlotte.

Speaker 4

Sure. Thanks, Matt.

Speaker 0

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

Speaker 2

Good afternoon, everyone. This is Arthur in for RK. Thank you for taking my question. Most of my questions have been answered. I'm just curious, besides the Shell bike program, has management discussed any other plan to further improve the shareholder value?

Speaker 3

We discuss it continuously. You might not,

Speaker 6

but you know our plan.

Speaker 3

No, look, the most important thing we can do to increase shareholder value is for our programs to succeed and our commercial program to continue on the path that it's at. 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, we'll talk about it.

Speaker 2

Thank you for that and congratulations on the strong quarter.

Speaker 3

Thank And you very 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.

Speaker 0

This concludes today's conference call. Thank you all for participating. You may now disconnect.