Corcept Therapeutics Inc

NASDAQ:CORT

Earnings Call Transcript 2022-Q1

[Operator]

Good day and thank you for standing by. 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 question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions].

And I would now turn the call over to Mr. Atabak Mokari, CFO. Please go ahead.

[Atabak Mokari, Chief Financial Officer]

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 first 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-K 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 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 first quarter was $93.7 million, an increase of 18% compared to the first quarter of last year. As a reminder, each year insurance reauthorisation and covers of our portion of the [Indiscernible] gap and Medicare for our e-coverage reduced our first quarter revenues. We expect our growth to continue and have reiterated our 2022 revenue guidance of $400 million to $430 million.

Net income was $22.8 million or $0.20 per share in the first quarter and our cash and investments increased $32 million in the first quarter to $368.1 million at March 31. 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 Hickma pharmaceuticals. Charlie?

[Charlie Robb, Chief Business Officer]

Thanks Atabak. There's little to report this quarter. As many of you know Teva is seeking to market a generic version of Korlym in violation of our patents. In March 2018, we sued Teva in federal district court, that litigation is still underway. In the midst of our federal court litigation, Teva launched a parallel challenge to the validity of one of our patents, the 214 patent, and procedure before the Patent Trial and Appeals Board or PETA, known as a post-grant review, or PGR.

In November of 2020, the PTAB rejected Teva’s arguments, upholding a 214 patent in its entirety. Teva appealed its loss to the Federal Circuit Court of Appeals, where in December of 2021 it lost again. The matter is closed. Having lost the PGR Teva can no longer challenge the 214 patent validity in our district court case. Teva can only argue that his proposed product would not infringe a position we believe has no legal or factual support.

A year ago, we filed for summary judgment based on Teva’s infringement of the 214 patent. Teva responded by filing its own summary judgment motion. 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 214 patent to decide the case in our favor, in which case Teva would be barred from marketing generic core elements until 2037 when the 214 patent expires. If the court rules in Teva’s favor, we will proceed to trial most probably sometime next year although it is impossible to say with certainty. There's no timetable for the summary judgment ruling no trial date and no schedule for any trial related activities. All this quiet, which is in some respects unfortunate. This case has gone extremely well for us and we would like to wrap things up.

In March 2021, we sued another ANDA filer, Hikma Pharmaceuticals and the same Federal District Court is hearing our case against Teva. In this case, the court has set a fact discovery deadline of July 1 this year. Nothing is scheduled after that. With respect to both Teva and Hikma, we are very confident in the strength of our legal position.

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

[Joseph Belanoff, Chief Executive Officer]

Thank you, Charlie. While we are getting closer to resuming our pre-pandemic way of life, some of the challenges posed by the pandemic persist. Even though recent COVID cases have tended to be mild, public health precautions taken by patients, physicians and our commercial team have made it more challenging for physicians to identify, diagnose, and optimally treat all of their patients, especially those with a complex disorder such as Cushing syndrome. Hopefully these challenges will be completely behind us very soon.

Despite residual effects of the pandemic, I want to stress how optimistic we are about the present and future of our Cushing syndrome business. This business is built on a strong foundation, and effective lifesaving medication promoted by a dedicated commercial team that puts the interests of patients first. Leading endocrinologist increasingly believed that there are substantially more patients with Cushing's Syndrome than was once assumed. For many of these patients Korlym is an excellent treatment.

As pandemic conditions and fears recede, we expect our growth to continue and we are reiterating our 2022 revenue guidance of $400 million to $430 million. We are also extremely optimistic about our clinical development programs. We have said for years the cortisol modulation has the potential to help treat many serious diseases. The data generated by our ovarian cancer program provides evidence of cortisol modulation broad application. In 2022, we will see important results for many of our other on-going clinical programs.

These programs are examining the lead candidates from a portfolio of more than 1000 proprietary cortisol modulators, many of which are attractive candidates for development. Like Korlym these compounds 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 Korlym most serious off target effects. Beyond sharing the qualities of strong cortisol modulation and not determining 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, others have more global effects.

These 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, NASH and, of course Cushing syndrome. We plan to start a Phase II trial in patients with ALS early next quarter and have additional compounds in Phase I and preclinical development. Korlym's commercial success has provided the funds to advance all of these programs and will continue to do so.

Our oncology program is testing three anti-cancer mechanisms, first postulated by investigators at the University of Chicago and confirmed by other prominent researchers. One mechanism is increasing apoptosis, program cell death when chemotherapy is meant to induce in solid tumors. Cortisol suppresses apoptosis, meaning, cortisol works against the beneficial effects of chemotherapy. In our successful trial in women with advanced ovarian cancer, the addition of our selective cortisol modulator relacorilant enhance the effect of chemotherapy likely by blunting cortisol anti-apoptotic effect.

While these patients disease had progressed on two or more previous lines of treatment, relacorilant appears to re-sensitize some of these patients to the beneficial effects of chemotherapy. As a reminder, our Phase II trial was a controlled multicenter study of 178 women with platinum-resistant ovarian cancer who were randomized to one of three treatment arms. 60 women received a higher dose of relacorilant on the day before, the day of and the day after they receive nab paclitaxel, we call this the intermittent arm. 58 women received a lower daily relacorilant dose in combination with nab paclitaxel, we this the continuous arm. And 60 women received nab paclitaxel alone. We call this the comparator arm.

The trial's primary endpoint was progression-free survival or PFS. The women who participated in our study were very ill and including those with platinum-refractory disease, all had experienced disease progression, despite prior lines of therapy. Although one had progressed on prior courses of taxane best therapy their median number of prior treatments was 3.

We presented the results from the study at the September 2021 European Society for Medical Oncology, ESMO, Congress and provided an update in our Investor event in March. As these results clearly showed relacorilant provide benefits to 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. The hazard ratio in this group was 0.66 with a p-value of 0.038. The women in the intermittent arm also experienced the statistically significant improvement in duration of response relative to those in the comparative arm, with a hazard ratio of 0.036 and a p value of 0.006.

The women in the intermittent relacorilant group also lived longer. The hazard ratio for this group was 0.67 with a p-value of 0.066. Their median survival or OS for this group was 13.9 months 1.7 months longer than for the NAB Paclitaxel monotherapy group which was 12.2 months. Importantly, safety and tolerability data for the women treated with relacorilant plus nab paclitaxel, was comparable to those who receive nab paclitaxel alone. We will share these results in an oral presentation at the American Society of Clinical Oncology ASCO annual meeting on June 6 in Chicago. Based on these positive results, we and our investigators are excited to conduct a Phase III trial. Our Phase III trial design is very similar to the design of our Phase II trial with some standard modifications.

For example, as is typical of late stage clinical trials, our Phase III trial will exclude patients with either primary, platinum refractory disease, patients who sadly, never respond at all to the standard platinum drug therapy. And those who have received have already received four or more prior lines of therapy. Excluding such patients from the Phase II trial results produced an even greater differential improvement in progression free survival duration of response and overall survival. Women in the intermittent arm experienced that statistically significant improvement in progression free survival with a hazard ratio of 0.58 a p-value of 0.016 duration of response with the hazard ratio of 0.26 and a p-value of point 0.001 and overall survival with a hazard ratio of 0.52 and a p-value of 0.01 relative to patients who receive now paclitaxel alone.

We have received very positive feedback from leading gynaecologic oncologists regarding the promise of relacorilant as a treatment for women with this desire disease. In their view, relacorilant’s potential benefits, improve survival without increased side effect burden would constitute an important medical advance. They feel that the relacorilant plus nab paclitaxel has the potential to become a new standard-of-care in ovarian cancer.

We have designed and will conduct our Phase III trial with advice from two leading research groups. The gynaecologic oncology group in the United States and the European Network of gynaecological oncology trials group in Europe. Most of our investigators will be drawn from these groups. We and members of the Gynaecologic Oncology Group will meet with the FDA in June to discuss the optimal path forward and we'll initiate our Phase III trial shortly thereafter.

Second mechanism by which cortisol modulation may prove useful is by blocking in important tumor growth pathway. Cortisol stimulation is a major reason why patients with metastatic prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide, eventually experienced resurgent disease. Deprived of 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 recently completed enrollment in our dose finding study of our selective cortisol modulator exicorilant combined with enzalutamide in men with castration-resistant prostate cancer. Investigators at the University of Chicago are conducting a similar study of relacorilant combined with enzalutamide in the same patient population. We expect to select an optimum dose of either relacorilant or exicorilant to take forward this quarter.

Our third mechanism seeks to reduce cortisol suppression of the immune system. Quality of cortisol that likely blunts the effectiveness of immunotherapy. We are conducting an open label Phase 1b trial of relacorilant plus the PD1 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 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 can treat these patients Cushing syndrome by reducing excess cortisol activity and by reversing cortisol induced immune suppression, allowing pembrolizumab to achieve its full cancer-killing effect. We plan to enrol 20 patients at seven sites in the United States. The primary endpoint of this study is objective response rate with secondary endpoints, including progression-free survival, duration of response and overall survival.

I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator, miricorilant, in patients with NASH, a serious liver disorder. Patients who received miricorilant in our Phase II trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of liver enzymes ALT and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and are rarely seen over any period of treatment.

As a reminder, our trial's primary endpoint was a 30% reduction in liver fat after 12 weeks of treatment. In fact, patients exhibited reductions ranging from 38.5% to 73.8% after receiving miricorilant for just a month. It may be that the rapidity of miricorilant fat reducing effect caused the patients ALT and AST to rise. One way the liver shifts fat is by metabolizing it into fatty acid, which in excessive amounts irritates the liver. Interestingly lipids in the blood of these patients did not increase, providing support to the idea that miricorilant cause the excess fat to be metabolized immediately within the liver.

The goal of our Phase 1b dose finding trial in patients with presumed NASH is to identify a dosing regimen that significantly reduces fat without causing excessive liver irritation. We are also evaluating miricorilant as a potential treatment for patients with another serious and widespread disorder, anti-psychotic-induced weight gain. 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 exact a steep price in the form of rapid and sustained weight gain, which leads to cardiovascular and metabolic disease. The average life expectancy of patients in the United States who chronically take antipsychotic medications has decreased by 20 years frequently due 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, both of which I’m pleased to say are now fully enrolled.

These trials seek 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 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 in AST, which typically exhibit sharp transient increases in the start of olanzapine therapy.

A paper describing these results was published in the Journal of Clinical Psychopharmacology. The GRATITUDE trial is evaluating whether miricorilant can reverse recent antipsychotic induced weight gain. Patients with schizophrenia or bipolar disorder will receive in addition to their established dose of antipsychotic 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 antipsychotic induced weight gain. Patients with schizophrenia will receive in addition to their established dose of antipsychotic 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 look forward to the data readouts from these trials in the fourth quarter. If the results are positive, we plan to advance our program to Phase III next year.

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, GRACE and GRADIENT. Like all of our proprietary molecules 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 intravitreal thickening and vaginal bleeding. By a different mechanism relacorilant also does not appear to cause hyperkalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym's pivotal trial.

Korlym induced hyperkalemia is a leading cause of Korlym discontinuation. Relacorilant's Phase II 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 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.

Our GRACE trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome. As a reminder GRACE has a randomized withdrawal trial design, all patients received relacorilant for 22 weeks in an open label phase. Those who need response criteria for improvement in glucose control, hypertension or both are randomized to continue treatment with relacorilant or placebo for 12 weeks.

While the pandemic had a real impact on the execution of this trial, 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 syndrome, which we plan to submit in the second half of 2023. Our second Phase III 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 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 is a first-controlled study to patients with this type of Cushing's syndrome. While we do not expect our NDA in Cushing syndrome to depend on data from GRADIENT, we do expect that its finding will help improve the care of these increasingly recognized patients.

Finally, a brief word about dazucorilant, which has shown promise in animal models of ALS. We have on track to initiate a Phase II trial early next quarter. This study is being shepherded by TRICALS, the leading ALS academic consortium in Europe. We will have more to say as that trial gets underway.

We expect our commercial growth to continue as pandemic conditions recede. Remember, even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities. We believe cortisol modulation can help treat many serious disorders. I believe, for which our development programs are now providing a growing body of evidence. Korlym and relacorilant for patients with Cushing syndrome provide and easy to see example of cortisol modulations benefits.

The data generated by our Ovarian Cancer Program provides a good example of cortisol modulations broad application. 2022 opened with strong overall survival results in our Phase II trial of adjunctive relacorilant in platinum resistant ovarian cancer. The remainder of 2022 will provide results from other important programs and our cortisol modulation portfolio; in particular, NASH and antipsychotic induced weight gain. Both are following up on extensive preclinical and encouraging early clinical results. We are also excited to start a Phase II trial using another of our proprietary compounds dazucorilant to treat patients with ALS. Last, but not least important additional proprietary compounds are advancing towards the clinic.

This is an exciting time at Corcept. I'd like to thank our employees for their tremendous effort and dedication. We recently announced three key additions to our commercial and development leadership teams and are expanding our teams more broadly to support what we believe is an incredibly broad and strong pipeline and a substancial commercial opportunity. I'll stop here for questions.

[Operator]

[Operator Instructions] We have our first question from Matt Kaplan from Ladenburg. Please go ahead.

[Matt Kaplan, Ladenburg]

Hi, congrats on the quarters strong results.

[Joseph Belanoff, Chief Executive Officer]

Thanks, Matt.

[Matt Kaplan, Ladenburg]

Just wanted to focus a little bit on relacorilant and in Cushing's and the GRACE and GRADIENT studies. Given your new guidance, how should we think about how long it should take to the parent NDA to file on the second half of 23? Is that roughly a six month process or something like that?

[Joseph Belanoff, Chief Executive Officer]

We're just doing it to introduce an important voice in the room. I'd like to reintroduce you to Bill Guyer who’s our Chief Development Officer to take that question less. Let me rest my voice for a little bit.

[Bill Guyer, Chief Development Officer]

All right, thank you. Thank you for that question. Since we're planning for an NDA in the second half of 2023, approximately four to six months prior to that we should have completed the study and then allow us to prepare for that NDA.

[Matt Kaplan, Ladenburg]

Okay, okay. That's helpful. And in terms of GRADIENT where how is that progressing and in terms of enrolment?

[Bill Guyer, Chief Development Officer]

GRADIENT that study is enrolling in parallel to that of GRACE. So very similarly.

[Matt Kaplan, Ladenburg]

Okay. So kind of on a parallel path…

[Bill Guyer, Chief Development Officer]

On a parallel path, yes.

[Matt Kaplan, Ladenburg]

Okay, great. And then in terms of the your metabolic program, metabolic disease program is in terms of the Phase II data for both of the both of the studies that are expected in the second half of this year in the fourth quarter. What, what would you need to see to get excited there to move into Phase III and in 23? In terms of antipsychotic weight gain, yes.

[Bill Guyer, Chief Development Officer]

It's great, I mean, there are many patients with antipsychotic induced weight gain. And this is the first time that we've ever done this important experiment. We're going to see a lot of data from both of these trials and learn a lot after we've analyzed the data to determine their implications. As we learned from this data set, we're going to primarily focus, as Joe said earlier on, evaluation of weight changes for miricorilant at different doses versus a placebo, as well as other metabolic factors that we're going to be evaluating the study compared to that placebo. So it's that collection of overall data set of weight changes and metabolic factors that will really help guide us forward on the next steps forward and how to proceed to Phase III next year.

[Matt Kaplan, Ladenburg]

Okay, great. Well thanks for taking the question.

[Operator]

We have our next question from Chris Howerton from Jefferies. Please go ahead.

[Chris Howerton, Jefferies]

Great. Thanks so much for taking the questions. I think maybe I'll start with thinking about the revenue guidance that you provided this year, relative to the first quarter performance, you're going to have to have the best three quarters that you've ever had in order to meet that guidance. I guess, what gives you the confidence that you'll be able to achieve that?

[Bill Guyer, Chief Development Officer]

Yes, no, understand the question. And again, like to reintroduce you to Sean Maduck, who was the President of our Endocrinology Division.

[Sean Maduck, Chief Commercial Officer]

Yes, thanks for the question Chris. And I want to just sort of reiterate what was said in the comments on what Joe had said previously, that, and we are reiterating our guidance and believe we remain on track for that. We'll talk a little bit about just the first quarter in particular, there's a couple of things that occurred in that there's the expected and the unexpected. The expected Atabak mentioned in his opening remarks, I mean, every January, we see challenges in the areas of insurance, three offs and doughnut [ph] hole gap coverage. And we make sure that treatments not interrupted for patients, we provide free drug until that paid coverage resumes. And that leads to more free drug but not fewer patients on medicine.

So I'd say that's the expected piece of it. The unexpected piece that affected us in Q1 was increased COVID concern, so Q4, and then the first half of Q1, the Omicron surge created disruption to our business, some disruption. I would say practices were closed again, like they were earlier in the year, and it was hard for our clinical specialists to get in. And patients were also hesitant to actually go and see their doctors, which is necessary for appropriate screening and testing. And in addition to that, the first time during this COVID window, our team was affected multiple members of our field force, were actually caught the virus and had to be out in the field, which limited their time in unseen positions.

So, I've talked about this in the past, but it takes many interactions with clinical specialists before a physician goes from Korlym [ph] naive to actually prescribing their prescription. And the lag effect of, of both of the Omicron surge in that limited field time had had an impact on our Q1. So all that being said, Omicron came and it went pretty quickly. And things are really starting to return to normal. And we're optimistic that improvement is going to continue through 2022, which is why we feel confident in the next three quarters.

[Bill Guyer, Chief Development Officer]

Yes, and just Chris, because I do want to emphasize and your math is absolutely correct. In order to meet our revenue guidance, we have to have the best quarters that we've ever had. And that is our expectation.

[Chris Howerton, Jefferies]

Okay, that's awesome. Okay, and then, if I may on the ovarian cancer Phase III trial, I could totally have this wrong. But my understanding is that experimental agents in combination need to be studied separately first, and I guess, what are your expectations of how the FDA is going to treat nab paclitaxel, given that it doesn't have a label in ovarian cancer going into that study?

[Bill Guyer, Chief Development Officer]

Thank you for that question. This is Bill Guyer. So when it comes to nab paclitaxel, there is a wealth of research that has gone along with nab paclitaxel, in ovarian cancer. So with that package, I think that helps us since this isn't just the first time we've ever studied it, we're adding to that body of research. The other key piece is those who have done the studies with nab paclitaxel primarily were the gynaecological oncology organization, the GOG. And they are the people who we partnered with to help us with the FDA. And they have a wealth of experience in working with the FDA to shepherd drugs through Phase III, but also to get drugs approved through the FDA. So we feel very confident that what we've designed in our trial will move forward very expeditiously. In addition, we're going to be talking with the FDA this quarter. And so we will seek their guidance on very shortly. But we still plan to initiate the Phase III study this quarter.

[Chris Howerton, Jefferies]

Okay. All right. Well, thanks so much. And then I guess, if I may, if you let me on the last one for the GRACE trial. I think point taken in terms of the COVID impacts on enrollment, but I actually can't remember what the sites where is there any impact of the unfortunate war conflict that we're having on enrollment? Or would there be any impact of loss to follow up potential?

[Bill Guyer, Chief Development Officer]

Yes, it's interesting Chris, because you're the first person to ask that question. And it's a good question, because we actually, I can tell you at the beginning of this study had actually considered having sites in Ukraine, and just, I guess in hindsight luckily did not have that there to sort of add to all the problems that exist in that country. So far, we really haven't seen that as much of an issue. Last week, we were at a very well attended investigator meeting in Europe. And we didn't really hear any feedback about that being a problem at all. So I'm going to say, no it has not. But, of course the future over there is far less certain than we'd like it to be. But no, at this point, no issue and we certainly would talk about it there became an issue.

[Chris Howerton, Jefferies]

Awesome. Okay. All right. Well, thanks for all the answers to my questions, and congratulations on the progress so far.

[Bill Guyer, Chief Development Officer]

You're welcome, Chris. Thank you.

[Operator]

We have our next question from Edward Nash from Canaccord Genuity. Please go ahead.

[Edward Nash, Canaccord Genuity]

Hi. Alright, guys, thanks for taking my question. I hope you guys are doing well. One of the things that have been any update in the New Jersey AG investigation, have they requested anything beyond the original inquiry today?

[Bill Guyer, Chief Development Officer]

I'm going to turn it back over to Charlie Rob.

[Charlie Robb, Chief Business Officer]

So yes. Hi, Ed. So the answer is that the nature of these investigations generally is that they start with initial list of stuff. And there's sort of some fluid back and forth, but really have nothing to announce about that investigation right now. But I think that it'd be more interesting, I can say is that I regret having nothing to announce about the investigation so far. And let me just provide a little bit of context. So you can understand why I'm saying that, which is that, the deal what, for those who don't follow this as closely, what it's referring to is a request for information that we received from the [Indiscernible] back in November of last year. As we announced then, and are doing we said we would cooperate with their inquiry, which we're certainly doing. And our approach is to provide them with the information that they want, as fast as we can and always faster than they're able to absorb. And why is that?

The reason is, we really want to stay ahead of them. We want them to always have information from us to review, because that's where you move things along as expeditiously as possible in their inquiry, although not directly causally linked or in any way, but is it in some way, sort of the culmination of research short seller allegations, -- any of that turned into a class action lawsuit that we're litigating now. And now we have this DOJ inquiry. And the reason I welcome speed and expeditious resolution in that case is these is the DOJ is staffed by public servants who are interested in the truth. And the truth for us is our friend.

And so I want to get our story in front of them as fast as we possibly can. Because I think that is how we will put this all behind us happily and be able to move forward without this distraction. So I wish there was something there will be something to say in the future. But right now, there's really nothing to add.

[Edward Nash, Canaccord Genuity]

That's great. I appreciate that detail. And then just my last question is just regarding relacorilant and antipsychotic induce weight gain. So how do you think about patient characteristics of those with recent versus long standing weight gain? I mean are they -- are there any differences in metabolic parameters between each group? Do you think the patients with long standing would have achieved homeostasis with regard to metabolic parameters after weight gain? And does that impact your thoughts on the potential duration of treatment for the patients versus recent..?

[Charlie Robb, Chief Business Officer]

Yes, very good question. I haven't gotten that one either. But I really, it's an opportunity for me to talk a little bit about it. Patients who take antipsychotic medications, and I can tell you, as someone who prescribes them tend to gain weight very quickly, and it is often very difficult for them to lose it no matter what they do over time, and yet they have to take their antipsychotic medication. As I sort of think about patients with schizophrenia, sort of routinely say, the worst thing a patient with schizophrenia can do is not take their medication. And second worst thing they can do is take their medication, because these medications really do cause serious, serious metabolic problems. And yet, for the purposes, which are very good at reducing psychosis, they're quite effective.

So we're doing the study. I know no one's ever done, sometimes either of these two studies, which is, can you reduce the weight gain caused by antipsychotic medication at all, and insert the news, the early study are people who you can really track to the very beginning when they began their antipsychotic medication, it's within the last six months. Can you actually take away that weight gain, or take a look at the other group of which the numbers in the United States are, are really ample of patients who have taken antipsychotic medication for a long time and have substantial weight gain, but are little, potentially a little less specific to the antipsychotic medication, because they live their life in America and American diet, and so on, and so forth.

So I don't know what the results of these studies are going to be, obviously, I have a hypothesis that our medicine will be beneficial for both of those groups. But as Bill mentioned before, much data that come and it's going to be very, very interesting, both for us, and for the field to see if we can really do something about this problem, whether it's a short term problem or a long term problem. It's a big problem. And I really look forward to seeing that turning over the cards in these blinded studies.

[Edward Nash, Canaccord Genuity]

Great, thanks so much. Really appreciate the color there. Look forward to a strong the next three quarters. Thank you.

[Charlie Robb, Chief Business Officer]

Thanks.

[Operator]

We have our next question from Greg Fraser from Truist Securities. Please go ahead.

[Gregory Fraser, Truist Securities]

Thanks. Good afternoon folks. I'm not sure if I missed this. But on GRACE did you comment on how many patients had been enrolled so far?

[Charlie Robb, Chief Business Officer]

No, I did not comment on the number of patients enrolled so far. We don't typically comment on the number of patients that are totally enrolled. But I will give you some commentary on coming out of the pandemic March was our best enrolled to date of this trial. So we're seeing good progress coming out of the pandemic.

[Joseph Belanoff, Chief Executive Officer]

Yes, that's just not a metric we report, Greg.

[Gregory Fraser, Truist Securities]

Understood. SG&A has been stepped up in the quarter, were there any temporary drivers of the higher spend in Q1? Or is that level sort of a new normal from which she'll grow?

[Joseph Belanoff, Chief Executive Officer]

Atabak?

[Atabak Mokari, Chief Financial Officer]

Sure, Joe. Hi Greg. That's that's pretty, as we talked about, we've expanded our teams and that's, that's a big driver of it. There are some temporary things like legal expenses, but for the most part, I think of that as our go forward.

[Gregory Fraser, Truist Securities]

Got it. Okay. And then you have a number of academic collaborators that are conducting studies of cortisol modulators in different settings like alcohol use disorder, epilepsy? Do you anticipate getting data from any of those studies this year, if you could just lay out what you might learn and when from those activities that will be helpful? Thank you.

[Joseph Belanoff, Chief Executive Officer]

Yes, this is really like a watershed day. I love talking about this stuff. No one ever asked me about it. So you got me started. We have at any given point, including, today about 35 different academic collaborations. Cortisol modulators, about half of the United States that have outside of the United States about half preclinical and half clinical.

And now to answer your question, yes, I do think that some of these studies will produce results this year, but just remember, they're not our studies. They belong to the clinical investigators or the academic investigators who are doing them. I can tell you, just as a broad statement, yes, you will see results from some of those studies this year. I do know where they are, particularly one which we were referring to, which is the relacorilant study in prostate cancer that will be relatively soon. But there are others I am and you mentioned it very very interested in seeing the study results in the alcohol use disorder study which is being done at Scripps. So fingers crossed. I'm as anxious to see those results as you are. And there's a broad range of them. So stay tuned.

[Gregory Fraser, Truist Securities]

Thanks for taking the questions.

[Operator]

We have our next question from Arthur He from H.C. Wainwright. Please go ahead.

[Arthur He, H.C. Wainwright]

Hey, good afternoon gentlemen. This is Arthur He for RK. Most of my question has been answered. I just want to follow up on the NASH study. Could you guys give us an update on the enrollment status for the study? And how many of those levels have been tested so far? And when could we expect to initially clean the data from the study? Thank you.

[Joseph Belanoff, Chief Executive Officer]

Thank you for that question. I really can't comment on the progress on each cohort. All I will tell you is the study is moving forward very well, with great screening and great enrollment activities for all the different cohorts. And since this is an open label trial, we're evaluating data for each patient and each cohort as it progresses. And the plan is to finish this trial and all the cohorts this year.

[Arthur He, H.C. Wainwright]

Awesome. Thank you.

[Joseph Belanoff, Chief Executive Officer]

Thank you, Arthur.

[Operator]

We have our next question from Tazeen Ahmad. Please go ahead. And please state your company.

[Unidentified Analyst]

Hey, this is Leon [ph] Wang on for Tazeen. Just a quick question. In terms of the some of the legal expenses that you mentioned, as an OpEx driver in 1Q. Can you give some more color on that? I mean, is this from IP or NDA? Or is it some other kind of legal expense that you are incurring?

[Joseph Belanoff, Chief Executive Officer]

No it's nothing, it's nothing new. We're at the stage of yes, we're producing information for the DOJ class action lawsuit happens to be kind of in the same calendar phase. So it, you don't have people charging you up by the hour in a room looking through documents and do an email queries and you can really rack up a bill. And that's what's going on here. But once, that sort of a bolus of expense that we just have to work through and, that's that's what you're seeing this quarter. Can't, can't comment on future quarters that much because it's always a little bit unpredictable how these things go, but you're seeing that this quarter for sure.

[Unidentified Analyst]

Okay, got you. So just for this quarter, you're expecting this more bolus of a quarter versus maybe perhaps some future quarters coming up?

[Joseph Belanoff, Chief Executive Officer]

Yes, I mean, we will get through this set of expenses. And that's all I can really say about it with any certainty.

[Unidentified Analyst]

All right, thank you.

[Operator]

We have our next question from Alan Leong from BioWatch News. Please go ahead.

[Alan Leong, BioWatch News]

Hey, thanks for taking my questions. And, Joe, it's good to hear from you again.

[Joseph Belanoff, Chief Executive Officer]

Yes, Alan.

[Alan Leong, BioWatch News]

I asked a couple of different questions. I wanted to get back in OT. I want to ask about the FKBP5 mRNA expression tests for GR receptor activities. Do you still like what you see? And assuming all goes well, do you aim to market the tests with a relacorilant commercial launch?

[Joseph Belanoff, Chief Executive Officer]

Yes, thank you for that question, Alan. Just to I know how closely you follow but just for the rest of the listeners. One of the things that we're really very interested in working on and seeing if we can come up with the more accurate test for cortisol activity that exists at the current time, that there really are no tests for cortisol activity, this time only cortisol level is mentioned. And Alan, again, I just say this for the whole audience. I don't I you may be aware of it. But we have now published the results from surgical and post-surgical study FKBP5 in patients with Cushing's disease, it's now it was peer reviewed, and it's in a very strong journal.

But the most important thing to tell you is we collect that information, the FKBP5 changes and all the studies that we do. And so we think it's very important. We'll see where that shakes out, certainly an experiment. But it would be a terrific experiment because one of the things that any clinician will tell you is that patients can have severe Cushing syndrome with moderate levels of cortisol excess and moderate Cushing syndrome with extraordinarily high levels of cortisol excess, it doesn't really match up so well. Our hope is that this measure will matchup more accurately and be very useful to physicians. Will it be ready at the time that the relacorilant NDA submitted? I doubt it. I think it's going to actually postdate that. But if you want to cross your fingers and assume that the results are good, I'm hoping it won't be too much behind that.

So, it's not going to be if the question was, is it going to be part of what's needed for the NDA for relacorilant and in Cushing syndrome. It is not, it really is its own findings, should it come to pass.

[Alan Leong, BioWatch News]

How was the Phase 1 for CORT125329? Was it -- what you hoped or is it just something that's put the rest for now?

[Joseph Belanoff, Chief Executive Officer]

You know, I can -- appreciate your understanding of all the detail, we're in. Hazel Hunt, who is our really fantastic Medicinal chemist and came up with all of these compounds, has several compounds, both preclinical and in clinical. I can tell you 125329, just you can file it away somewhere is a potent corticoid receptor modulator, where we take it uncertain at this point in time, because, as I commented on before, after we find out that it really is the modulator that we hope it to be, we then begin other biological assays to see where it can be best placed, is it a best in oncology is the best in metabolic diseases. And that's actually taking place right now.

[Alan Leong, BioWatch News]

Thank you. Looking forward to you next quarter.

[Joseph Belanoff, Chief Executive Officer]

Yes. Nice to talk to you again, Alan. I think this concludes all the people who had questions. So thank you very much for the detail. We'll obviously release information as we have it, and we'll talk to you about three months from now.

[Operator]

Ladies and gentlemen, this concludes today's presentation. Thank you for participating. You may now disconnect.