Good day and thank you for standing-by, Welcome to the Corcept Therapeutics Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Atabak Mokari, CFO. Please go-ahead.

Atabak Mokari - CFO

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 third quarter and providing a corporate update. A 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 at 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 may cause actual results to differ materially from those such statements expressed or implied. These forward-looking statements are described in today's press release and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements.

Our revenue in the third quarter of 2022 was $101.7 million, compared to $96.1 million in the third -quarter of last year. Net income was $34.6 million or $0.30 per common share in the third quarter compared to 30 $0.5 million or $0.24 per common share in the same-period last year. Our, cash and investments at September 30th was $401.2 million, an increase of $19 million in the quarter. We expect our revenue growth to continue and have tightened our 2022 revenue guidance to $400 million to $410 million.

I will now turn the call over to Charlie Robb our, Chief Business Officer to, provide an update on our litigation with generic manufacturers. Teva and Hikma Pharmaceuticals, Charlie?

Charlie Robb - Corcept Therapeutics Incorporated - Analyst

Thanks. Atabak. I have little to report. In March 2018 we sued Teva in Federal District Court to prevent it from marketing, engineering version of Korlym in violation of our patents. That lawsuit is still underway. Although there has been no activity for more than a year. In the second-quarter of 2021, we filed for summary judgment based on Teva's infringement of our 1,014 patent. Teva, as expected, responded by filing its own summary judgment. Summary judgment is a procedure whereby courts decide a case without holding a trial. The court has not responded to these motions.

Remember that Teva challenged the validity of the 214 patent that is the basis of our summary judgment motion at the Patent Office and lost, which means they cannot challenge the 214 patent's validity in District Court. As a result, it's only defense to our summary judgment motions that its proposed product would not infringe. A position we believe has no support. The court decides pending summary judgment motions in our favor that would be barred from marketing generic Korlym until 2037 when the 204 patent expires. Court rules in Teva's favor we will proceed to trial, most likely sometime next year. There is no timetable for the summary judgment motion ruling, no trial date and no schedule for any trial related activities.

In March 2021 we sued another file, Hikma Pharmaceuticals. Discovery in that case is scheduled to conclude in April 2023, no trial date has been set. With respect to both Teva and Hikma, we are confident and the strength of our legal position.

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

Joseph Belanoff - CEO

Thank you, Charlie. Our Cushing's syndrome business built on a solid foundation lifesaving medication promoted by a commercial team that puts the interest of patients first. Diagnosing and treating patients with complex disease such as Cushing's syndrome requires frequent in-person contact with 0:15:12. Our revenue in the third -quarter was affected by fewer than expected in interactions as many physician practices have not returned to pre-pandemic patterns of activity. To reflect this near-term challenge we are tightening our 2022 revenue guidance to $400 million to $410 million. We remain extremely optimistic about the present in the future of our Cushing's syndrome business. Korlym is an excellent treatment for patients with Cushing's syndrome and leading endocrinologists increasingly believe they are considerably more patients with Cushing's syndrome than was once assumed.

We are making substantial investments to improve the screening and treatment up these patients and we are confident these initiatives will contribute to our results in the coming quarters.

We're also very encouraged by the potential of our clinical development programs. Our clinical trials continue to advance generate data supporting cortisol modulation's broad therapeutic potential. We are very excited about our most recently initiated initiated studies ROSELLA, our confirmatory Phase-3 trial in platinum-resistant ovarian cancer and DAZALS our Phase 2 trial in ALS. We are looking two important readouts from our two Phase 2 trials and antipsychotic induced weight gain by the end of this year.

Our portfolio of more than 1,000 proprietary molecules together with funds provided by our commercial success will allow us to further broaden our therapeutic areas of interest. All of our compounds modulate cortisol specs by binding to the glucocorticoid receptor or GR. They do not bind to the progesterone receptor, and so don't cause some of Korlym approved products serious off-target effects. Interestingly, while all of our compounds modulating cortisols activity without modulating progesterone activity, they are not identical. 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, others have more global effects. These diverse qualities allowed us to study a wide variety of disorders.

Currently we are conducting programs in ovarian, adrenal and prostate cancer, ALS, antipsychotic induced weight gain, NASH and of course, Cushing's syndrome. We are also investigating cortisol modulation's role in other diseases and have additional compounds in clinical and preclinical development. Our Cushing's syndrome business has funded all of these activities and we'll continue to do so.

Our oncology program is testing three anti-cancer mechanisms first postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis. The program cell death the chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy. I suppressing apoptosis. And our successful Controlled Phase-2 trial in women with platinum-resistant ovarian cancer the addition of our selective cortisol modulator relacorilant enhance the effect of chemotherapy likely by blunting cortisol's anti-apoptic effect.

Relacorilant provide a meaningful benefit to many of the women in our study. While these women's disease had progressed on two or more previous lines of treatment, including previous taxanes, relacorilant appear to re-sensitize some of them chemotherapy;s beneficial effects. Those who received relacorilant intermittently the day before the day of and the day-after they received Nab-Paclitaxel exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received Nab-Paclitaxel monotherapy.

While our study was not powered to show in overall survival or OS compared to Nab-Paclitaxel monotherapy, women in the intermittent relacorilant group also live longer than those the comparator group with a p-value that approached statistical significance. I remind you that to date no approved therapies have demonstrated an overall survival benefit in-patients with platinum-resistant ovarian cancer.

In addition the women who received relacorilant plus Nab-Paclitaxel experienced no additional side-effect burden compared to do you received Nab-Paclitaxel alone. The results from this study would be multiple podium presentations at the, 2021 and 2022 European Society for Medical Oncology ESMO meetings and at the 2022 American Society of Clinical Oncology, ASCO Annual Meeting. ROSELLA our pivotal Phase 3 trial in platinum-resistant ovarian cancer is active and enrolling ROSELLA's design closely tracks our Phase 2 study with planned enrollment of 360 women randomized one-to-one to receive either relacorilant plus Nab-Paclitaxel or Nab-Paclitaxel alone.

The primary endpoint will be progression-free survival with overall survival the key secondary endpoint. We are conducting this study in collaboration with leading clinicians from the Gynecologic Oncology Group in the United States and the European Network of Gynecological oncology Trials Group in Europe. Our goal in Phase 3 is simply to replicate our positive Phase 2 results. Leading gynecological oncologist have told us that in their view, relacorilant's potential benefit survival without increased side-effect burden would constitute an important medical advance and then relacorilant plus Nab-Paclitaxel has the potential to become a new standard-of-care in women with platinum-resistant ovarian cancer.

The second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist Enzalutamide, eventually experience resurgent disease deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth. Our hypothesis that adding a cortisol modulator to androgen deprivation therapy close this tumor escape route. Next year in collaboration with the University of Chicago we will begin a, randomized, placebo-controlled Phase 2 trial of relacorilant plus Enzalutamide in-patients with prostate cancer early in their course of treatment before they have had their process detect.

The third mechanism of cortisol modulation seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune system, which may be lumpy effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immuno therapies such as Checkpoint inhibitors may increase the effectiveness of those therapies. We are conducting a Phase 1b trial of relacorilant plus the PD-1 Checkpoint inhibitor pembrolizumab and 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 alone is rarely effective in treating this form of adrenal cancer. Our trial is evaluating whether relacorilant can treat these patients Cushing's syndrome by reducing excess cortisol activity and by reversing cortisol induced immune suppression allow pembrolizumab to achieve its full cancer killing effect. The primary endpoint of the study is objective response rate with secondary endpoints, including progression-free survival, duration of response and overall survival.

I'll now provide an update on our ALS program. ALS commonly known as Lou Gehrig's disease is a devastating illness with the urgent need for better treatment. We are excited that we have initiated DAZALS a 198 patient randomized double-blind placebo-controlled Phase 2 trial with Dazucorilant in patients with ALS. Dazucorilant is a selective cortisol modulator that crosses the blood-brain barrier and showing great promise in animal models of ALS, improving motor performance and reducing neuroinflammation and muscular atrophy. We are conducting this important study in collaboration with TRICALS, a leading ALS academic consortium in Europe.

Next I'll turn to our program's metabolic disease which will produce important data suite. We are conducting two double-blind placebo-controlled Phase 2 trials of miricorilant GRATITUDE and GRATITUDE 2 in-patients with antipsychotic induced weight gain, serious and widespread disorder. In the United States, 6 million people take antipsychotic medications, such as olanzapine and Risperidone to treat illnesses, including Schizophrenia, bipolar disorder and depression. While these drugs are very effective they often cause rapid and sustained weight gain as well as cardiovascular and metabolic disease. The burden on patients is severe. The average life expectancy in patients in the United States you take antipsychotic medication chronically decreased by 20 years. These side effects also dissuade many patients from adhering through their treatment regimen.

The GRATITUDE trial seem to build-on the positive data from our study of miricorilant in healthy subjects. In 2020 we completed a trial in which 96 healthy subjects received olanzapine either 600 milligrams of miricorilant, 900 milligrams miricorilant in 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 the liver enzymes ALT and AST, which typically exhibit sharp transient increases at the start of olanzapine therapy. Paper describing these results was published last year in the Journal of Clinical Psychopharmacology.

GRATITUDE is evaluating whether miricorilant can reverse recent antipsychotic induced weight gain and GRATITUDE 2 is evaluating the reversal of long-standing antipsychotic induced weight gain. While the primary endpoint in both studies is reduction in body weight. I also want to stress the importance of general improvement to the patients metabolic health as, an indication of the patient's condition be treated more fully. For example improvements in lipids glucose control and markers of liver health would be highly desirable outcomes. These studies will these important data in many areas and we look-forward to the results by the end of this year.

Miricorilant is also our candidate treatment for patients with NASH a serious liver disease that afflicts millions of patients in the United States. In our prior NASH study, patients who received miricorilant exhibited large rapid reductions in liver fat but also substantial albeit transient elevations of the liver enzymes in AST and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and is rarely seen over any period of treatment. Patients exhibited reductions in liver fat ranging from 38.5% to 73.8% after receiving miricorilant for just one month. To put this in perspective, recall that the trial's primary endpoint was a 30% reduction in liver fat after 12 weeks. It may be that the rapidity of miricorilant's fat reducing effect caused the patient's ALP and AST to rise one way the liver sheds bad is by metabolizing against fatty acids which in excessive amounts irritate liver. Lipids in the blood of these patients did not increase, providing support the idea that miricorilant costs are excess fat to be metabolized immediately within the liver.

The goal of our Phase 1b dose-finding study in-patients with NASH is to identify a dosing regimen the captures the unprecedented repidity and magnitude of liver fat reduction without causing excessive liver irritation. Enrollment in this trial has been robust and we plan to share its results in first-half 2023.

Finally as most of you know we are evaluating relacorilant our planned successor to Korlym for the treatment of hypercortisolism in two Phase3 trials GRACE and GRADIENT. Relacorilant is 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 and so it does not cause PR related side-effects including termination of pregnancy endometrial thickening and vaginal bleeding. By a different mechanism relacorilant also does not appear to cause hyperkalemia low potassium serious side-effects experienced by 44% of patients in Korlym's pivotal trial.

Korlym induced hyperkalemia, it's a leading cause of Korlym discontinuation. Relacorilant Phase 2 efficacy and safety data were strong. 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 hyperkalemia. The trial results were published in Frontiers in Endocrinology last year.

Recent enrolling patients with any etiology of Cushing's syndrome has a randomized withdrawal trial design. All patients initially received relacorilant for 22 weeks in an open-label part of the study. Those who meet response criteria randomized to continue treatment relacorilant or placebo for 12 weeks. We and our investigators are eager to take race to the finish line. We expect GRACE to serve as the basis for our NDA submission in Cushing's syndrome, which we expect to submit in the second-half of 2023.

Our second Phase 3 trial GRADIENT is studying relacorilant impacts 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 their health outcomes are poor.

GRADIENT is the first controlled study in-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 caregivers increasingly recognized patients. GRADIENT, a randomized, placebo-controlled study has a planned enrollment of 130 patients.

To sum up, our commercial business continues to generate substantial profits, even after funding all of our development programs. We are extremely optimistic about the rest of future of our Cushing's syndrome business and are making significant investments to improve the screening and treatment of patients with Cushing's syndrome. We are confident that these initiatives will contribute to our results in the coming quarters and expect our revenue growth to continue. Our development programs continue to generate evidence validating our long-held belief that cortisol modulation has the potential to treat a wide range of diseases. Reducing cortisol activity is straightforward and effective way to treat Cushing's syndrome. It is now clear that excess cortisol activity that's other very serious disorders cortisol modulation can provide substantial benefits.

Ovarian cancer is a prime example but there will be others. Just opened multinational trial in ALS as no promise, we will have important data from our antipsychotic induced weight gain studies later this year and from our NASH program in the first-half of next year. While school, academic fields who use cortisol modulation and alcohol and other addictions is open. And in addition to relacorilant, miricorilant and Dazucorilant. We have many other cortisol modulators in our portfolio with potentially very different clinical attributes.

Corcept is steadily advancing across multiple fronts. Thank to our dedicated creative employees and our loyal investors for making this possible. I'll stop here for questions.

Question & Answers

Questions and Answers:

[

Operator

Thank you. [Operator Instructions] Our first-call comes from the line of Ed Nash of Jefferies. Your line is open.

Edward Nash - Canaccord Genuity - Analyst

Hi, it's actually Canaccord. thanks for taking my call. And really appreciate the overall pipeline overview. I just wanted to maybe touch on a point. Joe that you brought up the beginning of your of your comments just talking about the limited interaction there are still occurring. I mean the doctor's offices there. And I just wanted to kind of understand. I guess, better understand that because we're clearly not in the peak of COVID anymore now and things of relatively gotten back to normal. It seems that a lot of the doctors offices that they are still doing virtual, it's because of their choice or patients' choices. So I just wanted to understand just, kind of what is going to be the push to to kind of get things back to where they need to be our patients fully having a hard time getting appointments with the endocrinologist to either for follow-up or is it a lab issue or - just - I'm just trying to understand there's a lot of moving parts, but jind of - what is kind of the. The overall stopgap that's really causing the problem here on growth of Korlym.

Joseph Belanoff - CEO

Yeah. Ed, I think we really do understand your question. And I just want to re-introduce you to, Sean, he was the President of our Endocrinology division and runs all of our commercial activities. I think you could really give you a detailed answer to that question.

Sean Maduck - President of Endocrinology

Yeah thanks for the question. And again as Joe stated interactions, really not returns for us to pre-pandemic levels and right now we're, not sure if of a well. As a company who spent a, lot of time, educating on disease and physicians are aware of our proposal. They're not aware that it could be a source of efficiency comorbidities they don't look quarter screen for it. So we worked hard and we'll continue to work hard-to-find new ways to operate be perceived to be this new normal and involve innovate and, I'm confident that we'll continue to find new and creative ways to reach our target audience.

And part of your question was around although we're not maybe in the height of the pandemic some practices and health groups that, maybe weren't always. Up to seeing clinical specialists in the past. I would say, if somebody taken advantage of the change in of the situation now and closing their doors to pharmaceutical reps which is a shame, because a lot of the newest information in science is actually liver-based.

Joseph Belanoff - CEO

Yeah. What I'm really just like to answer the question just to really give you the kind of full around it is that I agree with you.When I'm out now it seems as if that many things are back to pre-pandemic normal, although not entirely. And. I think as a physician myself, I can tell you that there are many doctors who practices have changed in character to some degree. Now our major effort in terms of sales, really always relied on particularly at the very beginning physicians had prescribed many in-person sessions as person was educated with doc was educated over a period of time were they began screening.

I think the reality is that while many practices in some ways it return to normal, I think that other practices may not ever return to what was it like pre-pandemic. It's really on us to figure out ways to, make sure that education process continues in this new way. And I'm really very confident that we have very specific ideas of how we do that. But we're now accepting that this is how the world is going to be going-forward and we're going to operate from that perspective.

Edward Nash - Canaccord Genuity - Analyst

Great. Thanks so much.

Operator

Thank you. One moment for our next question, which comes from the line of. Dennis Ding of Jefferies. Your line is now open.

Dennis Ding - Jefferies - Analyst

Hey guys thanks for taking the question. Two questions from me if I may, number-one. If you look at the business picture perspective maybe, talk about your commitment and importantly, visibility and continuing to achieve a double-digit growth profile as we look towards 2023 and afterwards. And then number two maybe comment on the antipsychotic induced weight gain, trial is going to have some data by year end. Remind us what level evolved showed on percent weight-loss and the level of efficacy you hope to for a Phase 2 study. And maybe to follow-up on that, what opportunities do you see outside of AIWG and NASH. And, I'd be curious to get your view on the broader applicability in much larger markets.

Charlie Robb - Corcept Therapeutics Incorporated - Analyst

I guess 2Q, differnt areas of questioning. So let's go one at a time. The first question I'd like to as it relates to hypercortisolism and our commercialization efforts, I'd like to give it back to Sean.

Sean Maduck - President of Endocrinology

Yeah, thank you for the question. And I want to remind everybody about the significant growth potential that exists in this market. I mean there is now a substantial amount of independent research that suggest that hypercortisolism is essentially far more prevalent than previously thought. Accelerated disease but could there be 30,000 to 40,000 patients yes, And we're focused on unlocking that full potential. So despite these current challenges that we just went through we're confident in our path to sustained growth. But I thought I'd maybe take a minute to tell you a, little bit of a a couple of those key strategies are. We talked about how access has been challenge. So one of our key focus areas is to increase physician interactions and we're going do that by increasing the size of our customer-facing team and the support groups around that and working to improve the productivity of that thing.

The second big focus area for us is really around increasing screening and referral rates, by raising awareness and specialties that we believe have a rich patient populations. So I'm going to give you a couple examples. I mean for example one, gynocologists see a large number of treatment-resistant diabetics. Yet they do not routinely screen for Cushing's syndrome. Even though literature states about anywhere from 8% to, 10% of this population may have underlying anti-cortisol.

And another example radiologists frequently discover adrenal modules routine abdominal scans. However those patients are often referred to an endocrinologist for workout. Even though radiology guidelines that they should be.So not all specialties are aware of hypercortisolism and because of this many patients go undiagnosed. And we're, very focused on change that. We're going to use various marketing channels as Joe mentioned to get the message out to these customers through in-person print and digital means not all these patients will be Korlym candidates but at some will.

And really. I think to sum it up all of our strategies and tactics are focused on increasing physician interactions raising hypercortisolism awareness increasing patient screening and most importantly improving care for cortisol patients.

Joseph Belanoff - CEO

All right. And then as your second question has to do with our antipsychotic induced weight gain program. And I'm going to turn it over in a second to Bill Guyer, who is our Chief Development Officer and responsible for all the drugs in development for the antipsychotic induced weight gain. But just one small point, but. I think it's important one. You mentioned will 0:40:11 and. Just a factual point as is 0:40:11 these for the prevention of antipsychotic in fact olanzapine-induced weight gain, that's not for not for weight-loss. I think that's an important distinction.

So I'll turn you over now to Bill and he can give you an answer to what your variety questions.

Bill Guyer - Chief Development Officer

Thank you very much. So regarding our antipsychotic induced weight gain, focus it's from the GRATITUDE and GRATITUDE 2 studies. And yes we will have data by the end of this year. And we expect to evaluate both of those studies individually, but also collectively pulling the data just make sure we fully understand all the data from these trials, because we really think that we've got to take a holistic review of all of the data. And as Joe had stated earlier we want to, make sure that we analyze the data not just on the primary focus of weight gain, but also all of the other metabolic factors and in addition importantly psychiatric measures. And so that's going to be our focus is to, make sure that we fully understand all of that data, because we believe we produce the results and we communicate those results. We want to, make sure that we're clear what we understand and, therefore you understand the benefits of miricorilant can bring to these patients.

Joseph Belanoff - CEO

I think, Dennis, you also asked the question about the larger issue of the weight, maybe weight lost in general. And I just want to make sure all the listeners to know that we have no programs in weight-loss as a entity. It's really is about the specifics of patients who have gain weight by taking antipsychotic medications medications like olanzapine, Risperdal and Seroquel, that's where we're aiming right now. It's a very different program to considerable for weight-loss in general.

Charlie Robb - Corcept Therapeutics Incorporated - Analyst

Next question please?

Operator

Yes, thank you. Our next question comes from the line of. Greg Fraser of Truist. Your line is now open.

Greg Fraser - Truist Securities - Analyst

Sorry, thank you. Thanks for taking the questions and good afternoon. Quick follow-up on miricorilant. It sounds like will be when you make the announcement, you'll be providing them a lot of quantitative. Results from this study to help investors assess. Yeah kind of is that - is tat right way to, think about it.

Joseph Belanoff - CEO

Yes. I mean these days as you know are the first studies we know with miricorilant in antipsychotic induced weight gain or reversing antipsychotic induced weight gain. And we think they're going to provide a very rich dataset which will indicate our best path forward.

Greg Fraser - Truist Securities - Analyst

Got it, okay. For Korlym and the guidance and the growth that assumed in 2020. How much of the growth is driven by new patients versus price or higher average dose or changes in gross-to-net or any other factors.

Joseph Belanoff - CEO

I'm going to return you to Sean, would you [Indecipherable]

Sean Maduck - President of Endocrinology

So just to clarify the question is the forward-looking through the end of this year, that growth is driven by new patients and more tablets out-the-door to those patients.

Joseph Belanoff - CEO

And to, your question about dose. Our dose rarely changes it's been the same same average just for many years.

Greg Fraser - Truist Securities - Analyst

Got it. Okay. I'm sorry if I missed this, I got on late, but did you comment on the competitive environment, are you seeing any impact from RECORLEV or from the more mature products? I'm curious if the other companies maybe, you're seeing that the company is, doing things differently than they have in the past that maybe having an impact.

Joseph Belanoff - CEO

No, Greg, you didn't miss it but we understand the question and Sean will answer.

Sean Maduck - President of Endocrinology

Yeah, very similarly, how I responded in the past on this one. We haven't seen an impact. And we're pleased - honestly that more companies that are out there talking about hypercortisolism proposals and the reasons awareness which I just mentioned is lacking in certain areas and ultimately help patients.

Greg Fraser - Truist Securities - Analyst

Okay and then. On GRACE, has patient enrollment in hitting your targets?

Joseph Belanoff - CEO

Bill.

Bill Guyer - Chief Development Officer

No, we don't typically talk about enrollment. What we talk about is our focus on to make it NDA. And the team is focused on completing that NDA in the second-half of next year. And I'm very confident that the team is working hard to meet that target of submitting that NDA. We've taken - as I think I've said on previous calls, an all hands-on deck approach and that continues we're cross functionally working with investigators as well as working internally, not only to involve the study but also to start actively writing and completing the NDA today. Aand we are actively working on the NDA getting we're actively working with the FDA. We've completed investigator meeting in the U.s. and Europe and this year and we made many one-on-one visits to our key investigators. And it's clear after meeting with those investigators and talking about the trial that they have an unwavering support and excitement around relacorilant and GRACE study and are committed to completing this trial.

Greg Fraser - Truist Securities - Analyst

Have you said, when you expect to enroll the patients?

Bill Guyer - Chief Development Officer

We expect to submit an NDA by the second-half of 2023, that's our focus.

Greg Fraser - Truist Securities - Analyst

Understood. Okay thanks for taking the questions.

Operator

Thank you. One moment for our next question, which comes from the line of Alan Leong of BioWatch News. Your line is now open.

Alan Leong - BioWatch News - Analyst

This is Alan. Yeah hi, you find great questions. Let me ask how prevalent is NASH or fatty liver among chronic schizophrenics scheme? Is there any collected important further in the current antipsychotic induced weight gain trial?

Bill Guyer - Chief Development Officer

Yeah. your question was a little hard to hear I'm going to repeat it and, then I'll answer the question, I thought. I heard, we'll go from there. I think you were asking is well is it know or do we know the prevalence of NASH in-patients who have chronic psychiatric illnesses and are treated with antipsychotic medications. Is that question? We don't know who prevalence. I don't think anybody knows the prevalence. I think it's accounted in that way but it's not zero. Without a doubt these are patients who have, overweight and they have in many cases have been overweight from a real period of time. And those certainly. those two characteristics are certainly correlated with the development of fatty liver disease and NASH. So, I can't answer your question quantitatively, but qualitatively it's certainly something which exists.

Alan Leong - BioWatch News - Analyst

Yeah the same questions for ALS patients. What do you know about metabolic syndrome in ALS patients? Firstly, when. I look at the literature, seems like the CNS and neuromuscular patients think experience cortisol dysregulation. So love to get your commentary on that.

Joseph Belanoff - CEO

Good, thank you for giving me the opportunity to talk about that. It's really been known for quite a while probably 20 years that patients with ALS have hypercortisolism exhibit hypercortisolism never really been no what to do about that. If, that wasn't that leading to their disease but sort the key element for us was a, very strong academic research to treated in animal model that evolve - it was certainly the standard animal model for ALS and found treating them with cortisol modulator really led both pathological and clinical improvements.

Now how they relate to - I'm not sure if the question was about whether those patients have metabolic disturbances. I knew that less in some sense the issue of ALS so profound that you don't see a lot of reporting of other symptoms. So I never actually heard that question posed before and, I'm not sure I've ever seen any literature on it.

Alan Leong - BioWatch News - Analyst

Last question. You have the MRI NASH sub-study. Would it also be able to detect fibrotic composition structure. Because in the past MRI detect only cost changes, but. I want to make sure. I haven't missed anything and with very recent improvements in the MRIs.

Joseph Belanoff - CEO

Yeah so that question, I'm going to give you back to Bill who really is a NASH expert and has been in this field for many years. Go-ahead, Bill.

Bill Guyer - Chief Development Officer

Yeah, thank you for that question. So for the sub-study, I mean our focus mainly is around liver fat reduction. And the reason for that is it's been seen in most literature that when you get at least a 30% drop-in liver fat reduction, that corresponds to getting improvement in fibrosis. Now within the Phase 1b study we're not looking at fibrosis at this time, but there were other non-invasive markers that we're going to be using and analyzing those biomarkers to look at improvements in liver fibrosis. We will then take those learnings and apply them as we move forward into a Phase 2 study and use those same parameters and or use liver biopsies as well.But yes we will be gathering biomarkers to look at liver fibrosis to see if we're seeing improvements there as well.

Alan Leong - BioWatch News - Analyst

Thank you. Looking-forward to the next month.

Atabak Mokari - CFO

Yeah thank you Alan. And thank you to everybody who listened in. Look, really looking-forward to our next communication and hope you have a good rest of the week. Thank you very much.

Operator

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