Safestore Q3 2024 Earnings Call Transcript

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October 30, 2024

There are 10 speakers on the call.

Operator

Good day and thank you for standing by. Welcome to the CorSo Therapeutics Conference Call. At this time, all participants are in a listen only mode. After speaker presentation, there will be a question Please be advised that today's conference is being recorded. I'd like to hand the conference over to your first speaker today, Adhika Makar, Chief Financial Officer.

Operator

Please go ahead.

Speaker 1

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the Q3 and providing a corporate update. A copy is available at corecept.com. Our complete financial results will be available when we file our Form 10 Q with the SEC.

Speaker 1

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 might cause actual results to be materially different 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 ks and our quarterly reports on Form 10 Q, all of which are publicly available at the SEC's website. Please refer to those documents for additional information.

Speaker 1

We disclaim any intention or duty to update forward looking statements. Our revenue in the Q3 of 2024 was $182,500,000 an increase of 48% compared to the Q3 of last year. We expect our revenue growth to continue and have increased our 2024 revenue guidance to $675,000,000 to $700,000,000 Net income was $47,200,000 in the 3rd quarter compared to $31,400,000 in the Q3 of the prior year. Our cash and investments at September 30 were $547,600,000 compared to $492,500,000 at June 30. We acquired $23,400,000 of our common stock in the Q3 pursuant to our stock repurchase program, the net exercise of stock options by Corecept employees and the net vesting of restricted stock grants.

Speaker 1

I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Speaker 2

Thanks, Adebak. I don't have much to report this quarter. As many of you know, in March 2018, we sued Teva Pharmaceuticals to stop it from marketing a generic version of Korlym in violation of our patents. In December of last year,

Speaker 3

the

Speaker 2

trial court ruled against us, appealed that decision to the Federal Circuit Court of Appeals. Briefing in the matter is complete. The documents are available at the government's PACER website and the next step is for the Federal Circuit to schedule oral argument. The court could schedule oral argument as early as January of next year and issue a decision in the next quarter. If we prevail, Teva will lose FDA approval of its product and at least until the expiration of our patents in 2,037 would be unable to market the product.

Speaker 2

As I've said before, we are eager to advance this appeal. We strongly believe that our position is correct and that the Federal Circuit with its deep expertise in patent law will agree. I'll now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Speaker 4

Thank you, Charlie, and thank you everyone for joining us this afternoon. This is a very exciting time at Corcept. Physician awareness and understanding of hypercortisolism is accelerating. The results from our GRACE and GRADIENT Phase 3 studies clear the path for relacorilant's new drug application in Cushing's syndrome, which we will submit by year end. Our Phase 4 CATALYST trial in patients Cushing's syndrome and difficult to treat diabetes will generate data this quarter as will our trials in patients with ovarian cancer and ALS.

Speaker 4

Success in these endeavors will transform the company. We ended the Q3 with another high in both the number of new Korlym prescribers and the number of patients receiving treatment with Korlym. More physicians are now aware that hypercortisolism is much more prevalent than was previously assumed. As a result, they are screening and treating many more patients. When Korlym is prescribed, the expertise and infrastructure we have developed and refined over many years plays a critical role in helping patients and physicians achieve optimum benefit.

Speaker 4

Our Korlym business is thriving. Perhaps even more important, we've recently made substantial progress in the advancement of our proprietary selective cortisol modulator relacorilant. The story is not complicated. Patients in the GRACE and gradient studies experienced meaningful improvements in hypertension, glucose control, weight and body composition as well as other signs and symptoms of Cushing's syndrome. Relacorilant was very well tolerated and do not cause some of the serious adverse events that can be caused by other medications used to treat Cushing's syndrome, in particular, hypokalemia, endometrial hypertrophy, it's related vaginal bleeding, QT prolongation and adrenal insufficiency.

Speaker 4

As you recall, our pivotal Phase 3 GRACE trial is the basis for relacorilant NDA. In the trials open label phase, 152 patients with Cushing's syndrome and either hypertension, hyperglycemia or both received relacorilant for 22 weeks. Patients who met pre specified improvements were given the opportunity to enter the trials randomized double blind withdrawal phase in which half of the patients continue to receive relacorilant and half received placebo for 12 weeks. Patients in the open label phase of GRACE exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing's quality of life score and other important clinical measures. In the randomized withdrawal phase of GRACE, which compared patients taking relacorilant to those taking placebo, GRACE met its primary endpoint of maintenance and blood pressure control.

Speaker 4

The odds ratio, which is the study's primary end point was 0.17 with a P value of 0.02. An odds ratio of 0.17 means that patients taking relacorilant were 6 times more likely to maintain blood pressure response compared to those taking placebo. In addition, patients who continue to take relacorilant in the randomized withdrawal phase maintained the broad range of other improvements observed in the open label phase while those who receive placebo experienced the significant worsening of their symptoms. These outcomes would on their own provide powerful evidence for our NDA, but they do not stand on their own. Today we released results from our 2nd Phase 3 trial of relacorilant in Cushing's syndrome Gradient, a 22 week randomized double blind placebo controlled study in 137 patients whose hypercortisolism is caused by an adrenal adenoma or adrenal hyperplasia.

Speaker 4

Patients with this type of Cushing's syndrome often experience a less rapid decline, but their health outcomes are poor and include a significantly higher risk of premature death. Gradient's data will support our NDA by providing further evidence of relacorilant efficacy and safety confirming what we found in GRACE. Patients treated with relacorilant in Gradient exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight and body composition compared to baseline while patients who receive placebo did not. The trials primary endpoint was the improvement in systolic blood pressure compared to placebo with hyperglycemia, weight and body composition as secondary endpoints. Patients with hypertension who received relacorilant had an improvement of 6.6 millimeters of mercury in their systolic blood pressure at 22 weeks compared to baseline with a P value of 0.012.

Speaker 4

Patients who received placebo had an improvement of 2.1 millimeters of mercury in their systolic blood pressure at 22 weeks compared to baseline, a non significant improvement. The difference in the improvement in hypertension and those who receive relacorilant compared to those who receive placebo was not statistically significant. Patients whose hypertension worsened substantially during the study were given rescue hypertension medications. Notably, 5 patients who received placebo required rescue medication while only one patient who received relacorilant required it. Patients with hyperglycemia who received relacorilant experienced clinically meaningful and statistically significant improvements in glucose metabolism compared to those who received placebo.

Speaker 4

With placebo adjusted improvements in fasting glucose of 22 milligrams per deciliter, p value of 0.002 and hemoglobin A1c of 0.3 percent p value of 0.019 at 22 weeks. Patients in Gradient who receive relacorilant also experienced clinically meaningful and statistically significant improvements in body weight compared to those who received placebo with the placebo adjusted weight loss of 3.9 kilograms and a p value of 0.0001 at 22 weeks. An important feature of relacorilant as how well it was tolerated in both GRACE and gradient. In both studies, the most common adverse events were mild to moderate nausea, pain in the extremities and back and fatigue. These symptoms are consistent with the cortisol withdrawal patients with hypercortisolum experience following a rapid reduction in cortisol activity, whether due to surgery that removes an ACTH or cortisol secreting tumor or the start of medical therapy.

Speaker 4

As expected, there were no relacorilant induced instances of hypokalemia, endometrial hypertrophy or its related vaginal bleeding, no cases of adrenal insufficiency and no cases of QT prolongation. All of these adverse events can have serious health consequences and arise in patients taking the medications currently used to treat patients with hypercortisolism. The positive efficacy and safety results now supported by the global improvement seen in patients in the GRADIENT study promise a great advance for patients with Cushing's syndrome. Concurrent with our work on relacorilant's new drug application, we continue to look to further increase physician awareness and understanding of Cushing's syndrome. Our Phase 4 catalyst study of patients with difficult to treat diabetes has produced potent evidence to help advance the field.

Speaker 4

The prevalence results from catalysts were presented in the American Diabetes Association's annual scientific sessions in June. They clearly demonstrated that there are significantly more patients with hypercortisolism than was previously recognized. Of the first 1055 patients enrolled in Catalyst, 1 in 4 were found to have hypercortisolism. This is a far higher prevalence rate than was assumed with large implications for patient care. Hypercortisolism was even more common in patients in the study who in addition to their diabetes had already diagnosed cardiovascular disease, particularly in those who were using 3 or more medications to manage their hypertension.

Speaker 4

More than a third of this group of patients were found to have hypercortisolism. The second portion of the catalyst study is ongoing. In it, patients with hypercortisolism are randomized to receive either Korlym or placebo. The primary endpoint is the reduction in hemoglobin A1c between these groups. We expect results of this portion of the study by the end of the year.

Speaker 4

As you know, we are also studying relacorilant as a treatment for different types of cancer mediated by cortisol activity. In our pivotal ROSELA study, 381 women with platinum resistant ovarian cancer have been randomized on a one to one basis to receive either nab paclitaxel, a medication often prescribed to women with platinum resistant disease or nab paclitaxel plus relacorilant. Our expectation is that relacorilant will resensitize ovarian tumors to the effects of chemotherapy by blunting the anti apoptotic effect of cortisol activity. Rosella's design closely tracks the design of our successful controlled Phase 2 trial. In the Phase 2 trial, women who received relacorilant intermittently, the day before, the day of and the day after they received nab paclitaxel exhibited statistically significant improvement in progression free survival and duration of response compared to the group who received nab paclitaxel monotherapy.

Speaker 4

Women in the relacorilant group also live longer than those in the comparator arm. 29% of the patients who took intermittent relacorilant were alive 2 years after study start versus only 14% who took nab paclitaxel alone. Importantly, the women who received relacorilant plus nab paclitaxel experienced no additional side effect burden compared to those who received nab paclitaxel alone. We expect Rosella to replicate these results. Enrollment in rosela is complete.

Speaker 4

We anticipate having enough progression events to analyze the study's primary endpoint progression free survival by the end of this year. We are conducting Rosella in collaboration with leading clinicians from the Gynecologic Oncology Group or GOG in the United States and the European Network of Gynecological Oncology Trials or NGOT Group in Europe and deeply appreciate their enthusiasm and support. In anticipation of a successful outcome, we have established a standalone oncology division so we can move swiftly after the conclusion of Rosella to bring relacorilant to the women who can benefit from it. Positive results will also prompt us to explore relacorilant as a treatment for earlier stages of ovarian cancer and other solid tumors that express the glucocorticoid receptor. In addition to exploring its potential to resensitize tumors to chemotherapy, we are evaluating cortisol modulation's activity in 2 other mechanisms of action.

Speaker 4

In combination with androgen deprivation therapy and immunotherapy. Cortisol stimulation is thought to be 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 tumor switched to cortisol activity to stimulate growth. Leading academic researchers and clinicians hypothesize that cortisol modulation can block this tumor escape route. Our collaborators at the University of Chicago are currently enrolling a randomized placebo controlled Phase 2 trial of relacorilant plus enzalutamide in patients with early stage prostate cancer before these patients have had an initial prostatectomy.

Speaker 4

Another potential role of cortisol modulation is in combination with immunotherapy. Because cortisol suppresses the immune system, it may blunt the effectiveness of quick cancer therapies intended to stimulate the immune system. Adding a cortisol modulator to immunotherapy such as checkpoint inhibitors may enhance their effectiveness. Following our Phase 1b trial in advanced adrenal cancer, we are evaluating next steps to further understand the role of cortisol modulation in combination with immunotherapies in other tumor types and earlier stages of cancer. Our research team has developed a library of more than 1,000 selective cortisol modulators with distinct pharmacodynamic properties.

Speaker 4

Some are more potent and modulating cortisol activity across many tissue types, some are tissue specific. Some are very potent in oncologic models, some less so. Some cross the blood brain barrier, some don't. One of the compounds our scientists have created that is highly effective at getting into the brain is dasucorilant. We have advanced dasucorilant into clinical studies based on compelling data showing improved motor performance and reduced neuroinflammation and muscular atrophy in a commonly used mouse model of ALS.

Speaker 4

Our randomized double blind placebo controlled Phase 2 DASLs trial is ongoing at clinical sites in Europe, the United States and Canada. 249 patients with ALS have been randomized on a double blind basis to receive either 150 milligrams of dasicorilant, 300 milligrams of dasicorilant or placebo for 24 weeks. The primary endpoint is performance on the revised ALS functional rating scale score, a validated measure of the impact ALS has on patients. We expect to receive data by the end of the year. MASH, metabolic dysfunction associated steatohepatitis is a serious liver disorder that afflicts millions of patients in the United States.

Speaker 4

Cortisol modulation may serve as an effective treatment for MASH because cortisol activity has been implicated in both the initial development and progression of the disease. Our Phase 1b dose finding study of miricorilant found the patients who receive 100 milligrams orally just twice a week for 12 weeks experienced a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis and key metabolic and lipid measures such as insulin resistance, serum triglycerides and LDL. Importantly, miricorilant was also very well tolerated with none of the GI side effects which commonly arise in patients being treated for MASH. Our randomized double blind placebo controlled Phase 2b MONARCH study aims to expand on these encouraging results. MONARCH is enrolling 2 cohorts.

Speaker 4

In the first, 120 patients with biopsy confirmed MASH are randomized 2:one to receive either 100 milligrams of miricorilant twice weekly or placebo for 48 weeks. The primary endpoint for this cohort is reduction in liver fat with biopsy confirmed MASH resolution and fibrosis improvement key secondary endpoints. The 2nd cohort has a planned enrollment of 75 patients with presumed MASH. Patients in this cohort will be randomized 2:one to receive either 100 milligrams miricorilant twice weekly for 6 weeks followed by 200 milligrams of miricorilant twice weekly for 18 weeks or placebo for the whole 24 weeks. In this cohort, the primary endpoint is also reduction in liver fat.

Speaker 4

This is an incredibly exciting time at Corcept. Our commercial business is strong. The GRACE and GRADIENT trial results demonstrate that we developed a distinct superior treatment for patients with Cushing's syndrome. The prevalence results from our CATCH trial make it clear that there are far more patients with Cushing's syndrome than was previously assumed. By the end of this year, we expect to receive treatment data from our CATALYST study in patients with Cushing's syndrome as well as results from our pivotal ROSELA study in ovarian cancer and our DASL study in ALS.

Speaker 4

Positive results in these studies will be transformative for the company and more important lead to great benefit for the patients we serve. Every employee at Corcept understands the importance of the work we do. We are driven to support as quickly and effectively as we can patients with Cushing's syndrome and the other disorders where cortisol modulation can make a difference. Operator, let's proceed now to questions.

Operator

Thank you. At this time, we'll conduct a question and answer session. Our first question comes from the line of David Amsellem of Piper Sandler. Your line is now open.

Speaker 5

Thanks. So just have a couple on the gradient data. First, I guess I'm trying to better understand how to think about this. So you have on the blood pressure endpoint, you released active drug versus placebo, that difference was not statistically significant. I understand the differences versus baseline.

Speaker 5

But I guess my question here is, how should one interpret that, number 1, just given the absence of separation specifically versus placebo, not baseline? And then number 2, what gives you confidence that you will be able to not only file, but be able to get approval here with the Gradient data in hand given that backdrop? And then I guess the last part of the question is that is Gradient needed for approval? Has your communication with the FDA changed regarding the role of Gradient in the NDA? Thanks.

Speaker 4

Yes. Thank you, David. I think I understood all of those questions. And first, I'd just like to pass you over to Bill Geyer. Bill is our Chief Development Officer.

Speaker 4

You've heard him on previous calls and I think he can answer your data question very specifically.

Speaker 6

Yes, I think I can thank you Dave for that question. I can hopefully address all your questions that you've asked. So the most important thing to remember when you look at the gradient data is that as you had pointed out, we're very confident with submitting an NDA based upon the gradient data, but it's not just the gradient data. Our NDA will include a total of 4 studies. Our Phase 2 study and 3 Phase 3 studies, GRACE as our pivotal study, GRADEANT as a supportive study and another Phase 3 study we don't talk about as much, but I will today, the Study 452, which is our long term extension study.

Speaker 6

Altogether, this gives us the largest NDA package for Cushing's syndrome and we have hundreds of patients. So going to the FDA with this large of a package, no other company has done that thus far. Now Gradient from its inception was always designed to be supportive of GRACE and GRACE was always going to be our pivotal study and that's our agreement with the FDA. And we met our primary endpoint for GRACE. Now as we look at the GRACE trial, let me and even the GRACE trial or all of our trials together, let me remind you that Cushing's is a syndrome with many signs and symptoms, probably 20 or more signs and symptoms and hypertension and hyperglycemia are just 2 of those examples.

Speaker 6

When you look at the results from Gradient, it supports a successful path to an NDA because we see clinically significant improvements in all signs and symptoms of Cushing's syndrome, including improvements in blood pressure, blood glucose, weight, just to name a few. Now when it comes to blood pressure in all of our studies, we see an immediate drop in blood pressure that starts at week 2 and continues out through week 22. In addition to that as part of the syndrome, we see significant improvements in hyperglycemia endpoints for fasting blood glucose, AOC glucose and hemoglobin A1C as Joe had mentioned. But also when we look at patients with even higher hemoglobin A1c and have overt diabetes, we see an even greater response to all of those. And also when we look at all of the data, I'll tell you that relacorilant produces a clinically significant and statistically significant improvement in insulin resistance because we see improvements in AUC insulin and HOMA IR as well as when we look at other factors like coagulation factors, we see statistical improvements in coagulation factors all favoring relacorilant.

Speaker 6

As well, as Jod mentioned, we saw significant improvements in body weight and body compositions when we do DEXA scans, patients are losing fat from the visceral area, which is the bad fat in the belly area, which is what we wanted to see. So altogether, this speaks to the broad improvement of Cushing's syndrome from the GRADIENT study. In addition to that, when you look at the safety profile, it confirms what we saw in GRACE as well as Phase 2 and it's consistent with the known safety profile of relacorilant and no new safety signals were seen in the GRADIENT trial. And I've got to reiterate because this is really important because it helps differentiate relacorilant from any other product, especially that of Korlym. We see no reported cases of endometrial hypertrophy with or without vaginal bleeding, no cases of adrenal insufficiency, no evidence of drug induced hypokalemia and no QT interval prolongations.

Speaker 6

All of this is supportive of and similar to that of what we saw in GRACE. Now let me also come back to the other Phase 3 study that I mentioned in the Study 452 of why I feel confident with a positive NDA moving forward. This study is a study that takes patients that come from our Phase 2 trial and rollover or also come from grace and gradient and roll into this trial. And so we will see patients who have remained on relacorilant and some have been on this for over 7 years and we will be able to see data from this trial, people who were randomized placebo who now switch over to relacorilant and we'll be able to evaluate their progression as well. Now that the gradient study is unblinded, we can evaluate and look at this data and I will tell you that I highly supportive of what we've seen in all of our studies because hypertension response shows clinically significant and statistically significant improvements in both systolic and diastolic blood pressure at month 6 and it continues to improve out 2 years.

Speaker 6

So when you look at the totality of evidence that we see from all of these studies, we believe we have a successful path to a positive NDA for relacorilant that will happen in the coming weeks.

Speaker 4

Thank you, Bill. Next question please.

Operator

Our next question comes from the line of Matt Kaplan of Ladenburg. Your line is now open.

Speaker 7

Hey, guys. Can you hear me?

Speaker 4

Yes. Please speak up, Matt, a little bit. It's a little fuzzy. Yes.

Speaker 7

We'll try it out. Okay.

Operator

So yes, thanks for taking

Speaker 7

the question and thanks for clearing up the question on Gradient. That was very helpful already. And then just with respect to the results you're seeing for Korlym during the quarter, can you talk a little bit about if you're seeing an impact of the catalyst results, the initial results showing the prevalence in terms of additional screenings that are going on to ID identify patients with

Speaker 4

Cushing's? Yes, Matt. Thanks very much for the question. I understand that. And I think, Sean Madduk, the President of our endocrinology division is best prepared to answer that question.

Speaker 4

Go ahead, Sean.

Speaker 8

Hi, Matt. Thanks for the question. And yes, I mean the short answer is yes, we are starting to see some impact from Catalyst in those results. I will say though that it takes some time for those results to roll into guidelines and sort of practices and it's going

Speaker 6

to take some time to see

Speaker 8

the full effect. So our expectation is that we will see the full effect later into 2025 and beyond. What I wanted to touch on though is that we have seen tremendous volume growth in 2024 and obviously that catalyst was part of it, but I wanted to touch on specifically why. We're really just getting started and at the front of the curve of that growth. 1, Joe mentioned in his early comments and that's that hypercortisolism is once or is more prevalent than once thought.

Speaker 8

And it's no longer considered an ultra rare disease. There's been multiple studies in the last couple of years that have highlighted this fact catalyst enforced it with the 1 in 4 number and even the most recent FDA guidance into the 2023 highlighted that the number is bigger. So there's far more prevalence. Because of that prevalence, we're seeing more and more screening across multiple different physician groups. They're looking for these patients, they're finding them and the paradigm is shifting.

Speaker 8

But again, we're just at the beginning of that shift and we're confident that over time the screening is going to become a routine behavior. So with the increased recognition that this is more prevalent and the increased screening, we expect volume growth to be substantial in the near term and into the long term. I mean Korlym is a great product, but relacorilant is going to be even better. It shows efficacy across multiple and all signs and symptoms of Cushing's syndrome as Bill just walked through and Joe walked through in his comments and has significant safety benefit. It doesn't have the off target progesterone effects that we see with Korlym.

Speaker 8

It does not cause hypokalemia, it does not cause adrenal insufficiency and it does not cause QT prolongation, which really separates it from all the other products in the market. So because of this fact and because of where we see this growth going, we believe we're on a track to be a $3,000,000,000 business in the next 5 years.

Speaker 4

Thank you, Sean. And thank you. Next question, please.

Operator

Our next question comes from the line of Soumita Ramakanth of H. C. Wainwright. Your line is now open.

Speaker 4

Hi, RK.

Speaker 9

Thank you. This is RK from H. C. Wainwright. A quick question on the Rosella study.

Speaker 9

So in the prepared remarks, Joe, you were stating that you expect that you will have all the events that you need for analysis by the end of the year. So my question is, would you have enough time to even do the analysis and release the data? Or do you think you will just get to the point of having enough events by the end of the year?

Speaker 4

I'm going to pass you back to Bill for a second, but let me just answer your question generally. As opposed to other studies where for instance you have a 20 week, 24 week study with a double blind period and you break blind and you have the results, oncology studies are a little bit less determined because you're waiting for a number of events to occur and you do your best calculation and of course we have done that. Now I'll give you back to Bill to give you kind of specifics, but understand that lack of specificity in the and when a result will read out from oncology study is just par for the course for oncology studies. But Bill, please go ahead.

Speaker 5

Yes. So I'll add a

Speaker 6

little bit more color, but I completely agree with that. So when you look at relacorilant plus natpaclitaxel, a key thing that differentiates it probably from any other drug or combination in a platinum resistant ovarian cancer is that we see a differential effect on duration of response. And that duration of response is what you driving the PFS and OS benefit that we saw in Phase 2. So if you model that out, where we saw the greatest benefit in the Phase 2 trial is women who were living longer, especially 2 times the amount of women who were living longer at year 2 for relacorilant plus an APAC versus an APAC alone. Now we're replicating that in a study that is 2 to 3 times larger.

Speaker 6

And so it does just come down to the number of women that are progressing. Now we hope the longer this goes, this shows that women are living even longer on relacorilant plus nab paclitaxel. But once we cross that number of events, my team and I are prepared to analyze that data and announce it as soon as possible. And we're on track to see that across that endpoint by the end of the year and then analyze that data as soon as we can to then talk about it publicly and present it at a conference next year.

Speaker 4

Right. But we will release that information as soon as our analyses are done, Arcade. It's obviously very important event. You'll hear about it. We just can't tell you what day it's going to be yet.

Operator

Thank you. Thanks for the color. Okay.

Speaker 4

Sure. Next question, please.

Operator

Our next question comes from the line of Joon Lee. Your line is now open.

Speaker 4

Hi, Joon.

Speaker 3

Hey, thanks for taking our questions. Your characterization of gradient seems to be as a supportive study, while GRACE is the pivotal. Is that view shared by the FDA?

Speaker 4

Yes. And I'd like to pass you over to Charlie Robb, who handles all of our regulatory affairs. And I think can really provide some very useful color to you.

Speaker 2

Yes. Hi, Jun. The answer is yes. And I think one thing I'm sure you understand, but maybe not all of our listeners do is that this isn't some dark art where we have to guess what's on the FDA's mind. I mean, there's published guidance as well as any conversations a sponsor may have where the FDA has made it clear that a single well controlled study which we have in the form of our GRACE and the data from GRACE along with confirmatory evidence is sufficient to demonstrate a drug safety and efficacy.

Speaker 2

And Bill gave you really the strong clinical view, but I just want to underscore from the perspective of the person who has to go in with the team and present the arguments to the FDA, just what a good position we're in. I mean we've studied as Bill pointed out relacorilant in more patients with Cushing's syndrome than any other company with approved treatments out there. So we have a tremendous amount of data and our findings have been remarkably consistent from Phase 2 to GRACE to our extension study and now to Gradient. Patients who receive relacorilant got better across the entire range of Cushing's syndrome signs and symptoms. It's really as simple as that.

Speaker 2

It's that easy an argument to prevent to present to the FDA.

Speaker 3

Got it. And when was the last interaction with the FDA? And have you already have a pre NDA meeting with the FDA? It seems like you're trying to submit the NDA within weeks. So just curious if you've already had that conversation with the FDA?

Speaker 2

Well, so I mean, you'll appreciate, we don't comment on the particulars or interactions with the FDA. But I mean, I can say that we've talked to the FDA plenty about this program, about all of our programs and I foresee absolutely no impediments to getting our NDA in.

Speaker 3

Got it. And one more please. Did the hyperglycemia endpoint separate from the placebo? I just wanted to clarify if that was the case.

Speaker 4

The answer is yes. But Bill, let me just repeat the question that June said. Did the patients who were treated with relacorilant on hyperglycemia endpoints separate from those who were treated with placebo?

Speaker 6

Yes. They were all statistically significantly different favoring relacorilant for all hyperglycemia endpoints and those endpoints got better even as we got higher A1C. So we hit it for all patients and we hit it also for patients who were sicker with over diabetes.

Speaker 3

All right. Looking forward to the full data next year. Thank you.

Speaker 4

Okay. Thank you, June. Well, thank you everybody for tuning in. I'll just repeat, this is for all those who filed us for a long time, there's been no more exciting time at Corcept. This is when things are really starting to happen and we really have an opportunity to help a much larger group of patients than we previously helped.

Speaker 4

So we're really very, very excited about this and look forward to sharing the next results for you and talking to you next quarter. Thank you.

Operator

This concludes the question and answer session. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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