Corcept Therapeutics Incorporated

session. Good day, and thank you for standing by. Welcome to the Corset Therapeutics Conference Call. At this time, all participants are listening remotely. After speaker's initiation, there will be a question and answer session. For any questions during the session, you'll need to press star 1 on your telephone, who then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 again. Please be advised that today's conference is being recorded. I'd like to hand the conference over to your first speaker today, Latakha Makar, Chief Financial Officer. Please go ahead.

Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the third quarter and providing a corporate update. A copy is available at CoreSet.com. Our complete financial results will be available when we file our 410Q with 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 might cause actual results to be materially different from those such statements express or imply. 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, all of which are publicly available at the SEC's website. 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 2024 was $182.5 million, an increase of 48% compared to the third quarter of last year. We expect our revenue growth to continue and have increased our 2024 revenue guidance to $675 to $700 million. Net income was $47.2 million in the third quarter compared to $31.4 million in the third quarter of the prior year. Our cash and investments at September 30th were $547.6 million compared to $492.5 million at June 30th. We acquired $23.4 million of our common stock in the third quarter pursuant to our stock repurchase program, the net exercise of stock options by CoreSept employees, and the net vesting of restricted stock grants. I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie?

Thanks, Adelbach. 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 Coraline in violation of our patents. In December of last year, the 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 would lose FDA approval of its product and, at least until the expiration of our patents in 2037, would be unable to market the product. 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?

Thank you, Charlie, and thank you, everyone, for joining us this afternoon. This is a very exciting time at CORSET. Physician awareness and understanding of hypercortisolism is accelerating. The results from our GRACE and GRADIENT Phase III studies clear the path for relacorlin's new drug application in Cushing syndrome, which we will submit by year-end. Our Phase 4 Catalyst Trial in patients with Cushing Syndrome and difficult-to-treat diabetes will generate data this quarter, as will our trials in patients with ovarian cancer and ALS. Success in these endeavors will transform the company. We ended the third quarter with another high in both the number of new corallum prescribers and the number of patients receiving treatment with corallums. 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 Coralim 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. Our Coralim business is thriving. Perhaps even more important, we've recently made substantial progress in the advancement of our proprietary selective cortisol modulator, Reliquarolent. The story is not complicated. Patients in the GRACE and GRADIENT studies experience meaningful improvements in hypertension, glucose control, weight and body composition, as well as other signs and symptoms of Cushing syndrome. Reliquaryland 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 syndrome. In particular, hypokalemia, endometrial hypertrophy, its related vaginal bleeding, QT prolongation, and adrenal insufficiency. As you recall, our pivotal Phase III GRACE trial is the basis for Reliquaryland's NDA. In the trial's open-label phase, 152 patients with Cushing syndrome and either hypertension, hyperglycemia, or both received reliquarylant for 22 weeks. Patients who met pre-specified improvements were given the opportunity to enter the trial's randomized double-blind withdrawal phase, in which half of the patients continued to receive reliquarylant 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, cushioned quality of life score, and other important clinical measures. In the randomized withdrawal phase of GRACE, which compared patients taking relacoralant to those taking placebo, GRACE met its primary endpoint of maintenance of blood pressure control. The odds ratio, which is the study's primary endpoint, was 0.17, with a p-value of 0.02. An odds ratio of 0.17 means that patients taking reliquarylant were six times more likely to maintain blood pressure response compared to those taking FEBO. In addition, patients who continued to take reliquarylant in the randomized withdrawal phase maintained the broad range of other improvements observed in the open-label phase while those who received placebo experienced a 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 second Phase III trial of relic-coagulant in Cushing 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. Patients with this type of Cushing syndrome often experience a less rapid decline, but their health outcomes are poor and include a significantly higher risk of premature death. Gradients data will support our NDA by providing further evidence of relic prevalence efficacy and safety, confirming what we found in GRACE. Patients treated with reliquaryland and gradient exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, and body composition compared to baseline, while patients who received placebo did not. The trial's 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 relacoralant 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. 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 in those who received relacoralant hypertension in those who received relacoralant compared to those who received placebo was not statistically significant. Patients whose hypertension worsened substantially during the study were given rescue hypertension medications. Notably, five patients who received placebo required rescue medication, while only one patient who received relacoralant required it. Patients with hyperglycemia who received relacoralant experienced clinically meaningful and statistically significant improvements in glucose metabolism compared to those who received placebo. With placebo-adjusted improvements in fasting glucose of 22 milligrams per deciliter, p-value of 0.002, and hemoglobin A1c of 0.3%, p-value of 0.019 at 22 weeks. Patients in gradient who received relacoralin 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 Brella-correlant is 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 hypercortisol 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. As expected, there were no reliquaryland-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 syndrome. Concurrent with our work on relacorlin's new drug application, we continue to look to further increase physician awareness and understanding of Cushing syndrome. Our phase four catalyst study of patients with difficult-to-treat diabetes has produced potent evidence to help advance the field. The prevalence results from Catalyst 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 1,055 patients enrolled in Catalyst, one in four 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 three or more medications to manage their hypertension. 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 quaralim 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. As you know, we are also studying relacoralin as a treatment for different types of cancer mediated by cortisol activity. In our pivotal Rosella study, 381 women with platinum-resistant ovarian cancer have been randomized on a one-to-one basis to receive either nabpaclitaxel, a medication often prescribed to women with platinum-resistant disease, or nabpaclitaxel plus relacoralin. Our expectation is that relacoralin 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 II trial. In the Phase II trial, women who received reliquaryl intermittently, the day before, the day of, and the day after they received napaclitaxel, exhibited statistically significant improvement in progression-free survival and duration of response compared to the group who received napaclitaxel monotherapy. Women in the relacoralin group also live longer than those in the comparator arm. 29% of the patients who took intermittent relacoralin were alive two years after study start versus only 14% who took napaclitaxel alone. Importantly, the women who received relacoralin plus napaclitaxel experienced no additional side effect burden compared to those who received napaclitaxel alone. We expect Rosella to replicate these results. Enrollment in Rosella is complete. 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 Reliquorin to the women who can benefit from it. Positive results will also prompt us to explore reliquaryland 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 modulations activity in two other mechanisms of action. 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 tumors switch 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 two trial of relacoralin plus enzalutamide in patients with early stage prostate cancer. Before these patients have had an initial prostatectomy. Another potential role of cortisol modulation is in combination with immunotherapy. Because cortisol suppresses the immune system, it may blunt the effectiveness of 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. 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 dasuquerulant. We have advanced DASL-Correlant 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. Our randomized double-blind placebo-controlled Phase II 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 dasa-correlant, 300 milligrams of dasa-correlant, or placebo for 24 weeks. The primary endpoint is performance on the revised ALS functional ratings 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. 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 miracoralant found that 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, miracorrelant was also very well tolerated with none of the GI side effects which commonly arise in patients being treated for MASH. A randomized, double-blind, placebo-controlled Phase IIb MONARCH study aims to expand on these encouraging results. Monarch is enrolling two cohorts. In the first, 120 patients with biopsy-confirmed MASH are randomized two to one to receive either 100 milligrams of miracluralin 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 second cohort has a planned enrollment of 75 patients with presumed MASH Patients in this cohort will be randomized two to one to receive either 100 milligrams of miracoralin twice weekly for six weeks, followed by 200 milligrams of miracoralin twice weekly for 18 weeks, or placebo for the whole 24 weeks. In this cohort, the primary endpoint is also a reduction in liver fat. This is an incredibly exciting time at Corsept. Our commercial business is strong. The GRACE and GRADIENT trial results demonstrate that we've developed a distinct, superior treatment for patients with Cushing syndrome. The prevalence results from our CATALYST trial make it clear that there are far more patients with Cushing 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 syndrome, as well as results from our pivotal Rosella study in ovarian cancer and our DASL study in ALS. 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 CORSAP understands the importance of the work we do. We are driven to support, as quickly and as effectively as we can, patients with Cushing syndrome and the other disorders where cortisol modulation can make a difference. Operator, let's proceed now to questions.

Thank you. At this time, we'll conduct a question and answer session. As a reminder to ask a question, you'll need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from a line of David Anselm of Piper Sandler. Your line is now open.

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 release active drugs versus placebo. That difference was not statistically significant, I understand. the differences versus baseline. But I guess my question here is, you know, how should one interpret that? Number one, just given the absence of separation specifically versus placebo, not baseline. And then number two, 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.

Yeah, thank you, David. I think I understood all those questions. And first, I'd just like to pass you over to Bill Guy. Bill's our Chief Development Officer. You've heard him on previous calls, and I think he can answer your data questions very specifically.

I think I can. Thank you, Dave, for that question. I can hopefully address all your questions I've asked. So, you know, 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 four studies, our phase two study, and three phase three studies, GRACE as our pivotal study, GRADIENT as the supportive study, and another phase three study we don't talk about as much, but I will today, is study 452, which is our long-term extension study. Altogether, this gives us the largest NDA package for Cushing 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 GRADIENT 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 two of those examples. 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 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 two 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, AUC glucose, and hemoglobin A1C, as Joe had mentioned. But also when we look at patients with even higher hemoglobin A1Cs 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 reliquarolin 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 relacorlin. As well, as Joe 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 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 II, and it's consistent with the known safety profile of relacorlin, 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 relacorlin from any other product, especially that of corallum. 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. 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 three study, study four, five, two, of why I feel confident with a positive NDA moving forward. This study is a study that takes patients that come from our phase two trial and roll over, or also come from GRACE-ing gradient and roll into this trial. And so we will see patients who have remained on relacorlin, and some have been on this for over seven years, and we will be able to see data from this trial, people who were randomized placebo who now switch over to relacorlin, 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'm 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 six, and it continues out and continues to improve out two years. 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 relacorlin. That will happen in the coming weeks.

Thank you, Bill. Next question, please.

Our next question, constant line of Matt Kaplan of Levenberg. Your line is now open.

Hey, guys. Can you hear me?

Yeah. Please speak up, Matt, a little bit. It's a little fuzzy. We'll try to.

OK. So yeah, thanks for taking 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 Coraline 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 identify patients with Cushing's?

Yes, Matt. Thanks very much for the question. I understand that. And I think Sean Madduke, the president of our endocrinology division, is best prepared to answer that question. Go ahead, Sean.

Hi, Matt. Thanks for the question. And yeah, 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 to take some time to see the full effects. So our expectation is that and 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. One, Joe mentioned it in his early comments, and that's that hypercortisolism is more prevalent than once thought. and it's no longer considered an ultra-rare disease. There's been multiple studies in the last couple years that have highlighted this fact. Catalyst enforced it with the one in four number, and even the most recent FDA guidance in 2023 highlighted that the number's 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. But again, we're just at the beginning of that shift, and we're confident that over time, this 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 in the long term. I mean, coralline is a great product, but relicoralline 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 benefits. It doesn't have the off-target progesterone effects that we see with Coralum. 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 billion business in the next five years.

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

Our next question is, consult line from Ron Markoff of HC Wainwright. Your line is now open.

Hi, RK. Thank you. This is RK from HC Wainwright. A quick question on the Rosella study. 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?

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 24-week study with a double blind period and you break the 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, you know, that lack of specificity and when a result will read out from an oncology study is just par for the course for oncology studies. But Bill, please go ahead.

Yeah, so I'll add a little bit more color, but I completely agree with that. So, You know, when you look at relicorlin plus napaclitaxel, 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's driving the PFS and OS benefit that we saw in phase two. So if you model that out, where we saw the greatest benefit in the phase two trial is women who were living longer, especially two times the amount of women who were living longer at year two for reliquaryland plus NatPak versus NatPak alone. Now, we're replicating that in a study that is two to three times larger, 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 reliquaryland plus NatPak Cotaxil. 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 you know, cross that endpoint by the end of the year and analyze that data as soon as we can to then talk about it publicly and present it at a conference next year.

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

Thank you. Thanks for the call. Okay.

Sure. Next question, please.

Our next question comes from a line of Chun Li. The line is now open.

Hi, June. 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?

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.

Hi, June. The answer is yes. And, you know, I think, you know, one thing I'm sure you understand, but maybe not all of our listeners do, is that, you know, this isn't some, you know, a dark art where we have to guess what's on the FDA's mind. I mean, there's published guidance, as well as, you know, 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's safety and efficacy. And, you know, Bill gave you really the strong clinical view, but I just wanted to underscore, you know, 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, reliquarolin in more patients with Cushing 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 two to grace to our extension study and now to gradient. Patients who received relacoralin got better across the entire range of Cushing syndrome signs and symptoms. It's really as simple as that. It's that easy an argument to present to the FDA.

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

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.

One more, please. Did the hyperglycemia endpoints separate from the placebo? I just wanted to clarify if that was the case.

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

Yes, they were all statistically significantly different, favoring relachoralin 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 overt diabetes.

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

Okay. Thank you, June. Well, thank you, everybody, for tuning in. I'll just repeat, this is, for all those who followed us for a long time, there's been no more exciting time at CORE-SEP. 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. 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.

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