Q3 2024 Corcept Therapeutics Inc Earnings Call

and the name of the world.

Good day and thank you for spending by. Welcome to the course of their beautiful conference hall. At this time, all participants are listening only more.

[inaudible]

For ask a question during this session, we need to press star one more to the phone within here on our main message by the end of the race. To withdraw your questions, please press star one more again. Please be advised that today's conference is through the call date. Alright, the conference will be your first speaker today. I'd like to come a car and chief on your drafts for please go ahead.

Hello everyone, good afternoon and thank you for joining us. Today we issue the press release announcing our financial results for the third quarter and providing a corporate update. The copies available at courseeth.com. Our complete financial results will be available when we file our 410 Q with SEC.

Today's calls being reported. 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 risk and uncertainties, which might cause actual results to be materially different from those such statements expressed or imply.

These forward-looking statements are described in today's press release and the written uncertainties of effect them are described in the press release and are in your report on Form 10K and are quarterly reports on Form 10K, all of which are probably available at the SEC's website.

Police refer to those documents for additional information. We display them any intention or duty to update forward looking statements.

Speaker Change: A revenue in the third quarter of 2024 was $182.5 million and increased a 48% compared to the third quarter of last year. We expect our revenue growth to continue and have increased our 20-24 revenue guidance to $675-$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 $447.6 million compared to $492.5 million at June 30th.

Speaker Change: We acquired $23.4 million of our common stock in the third quarter pursuant to our stock rebirths program, the net exercise of stock options by course up to employees and the net thing of restricted stock grants.

I will now turn the call over to Charlie Robb, our chief business officer Charlie. Thanks, madamak.

I don't have much to report to this quarter. As many of you know, in March 2018 we sued Teva for our musuticals to stop it from marketing a generic version of Coralum and violation of our patents. In December of last year, the Frog Court ruled against us.

the Peel that decision to the Federal Circuit Court of Appeals.

Briefing in the matter is complete the documents reveal with the government's piece or website and the next step is for the Federal Circuit's Federal Order argument.

The Court could schedule our oral argument as early as January of next year, and issue a decision in the next quarter.

If we prevail, Teval 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 the federal circuit with its deep expertise and patent law will agree. On 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 Courset. Physician Awareness and Understanding of Hypercoursalism is accelerating. The results from our Grace and Gradient Phase 3 studies clear the path for fellow coral launch new drug application in Courset Syndrome, which we will submit by year end.

Our Phase 4 catalyst trial in patients with cushion syndrome and difficult to treat diabetes will generate data this quarter as will our trials and patients with a variant cancer and ALS.

Success and these endeavors will transform the company.

We ended the third quarter with another high in both a number of new Quarlem prescribers and a number of patients receiving treatment with Quarlem.

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 Coral on this 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 Coralum business is thriving. Perhaps even more important, we recently made substantial progress in the advancement of our proprietary selective cortisol modulator, RELICOR, or LUNTS.

The story is not complicated. Patients in the grace and gradients studies experience meaningful improvements in hypertension, glucose control, weight and body composition, as well as other science and symptoms of cushion syndrome.

Speaker Change: Relocorlant 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, hypocholemia andometrial hypertrophy, it's related vaginal bleeding.

QT Prolongation and Drinal Insufficiency.

As you recall, our pivotal phase three grace trial is the basis for relicorolant NDA. In the trials open label phase, 150 two patients with cushing syndrome and either hypertension, hyperglycemia, or both, receive relicorolant 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 relic oralent and half received placebo for 12 weeks.

Patients in the open label phase in grace exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waste or conference, cognition, cushioned quality of life score, and other important clinical measures.

And in the randomized withdrawal phase of grace, which compared patients taking relicorolent 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 relative to 6 times more likely to maintain blood pressure response compared to those taking fibo.

In addition, patients who continue to take relic oral ent and the randomized withdrawal phase maintained the broad range of other improvements observed in the open label phase while those who receive placebo experience 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 second phase 3 trial of Brawel Aquarland and Cooching Syndrome, gradient.

22-week randomized double-blind placebo-controlled study in 137 patients whose hyperchorus 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.

Speaker Change: Greetings, Dad. We'll support our NDA by providing further evidence of relative, relative, oral and efficacy and safety, confirming what we found in grace.

Patients treated with relic oral and gradient, exhibited clinically-meaning fall and statistically significant improvements in hypertension, hyperglycemia, weight and body composition compared to baseline, while patients who received placebo did not.

The trials primary endpoint was the improvement in systolic blood pressure compared to placebo with hyperglysemia, weight and body composition as secondary endpoints.

Speaker Change: Patients with hypertension who received relic oral ant had an improvement of 6.6 mm of mercury in their systolic blood pressure at 22 weeks compared to baseline with the p-value of 0.012.

Patients who receive placebo had an improvement of 2.1 millimeters of mercury in their systolephaloporescer at 22 weeks compared to baseline, a non-significant improvement.

Speaker Change: The difference in the improvement in hypertension in those who receive oral ant compared to those who receive placebo was not statistically significant.

Patients use hypertension worsens substantially during the study, were given rescue hypertension medications. Notably, five patients who receive placebo required rescue medication, while only one patient who receive relic oral and required it.

Patients with Hyperglisemia, who received Relicorolant, experienced clinically-meaning full and statistically significant improvements in glucose metabolism compared to those who received placebo.

Speaker Change: With placebo adjusted improvements in fasting glucose of 22 milligrams per desolator, p-value of 0.002 and he beglub an A1C of 0.3% p-value of 0.019 at 22 weeks.

Patients and Gradient who receive Belacoralid, also experience clinically meaningful and statistically significant improvements in body weight.

2.2% compared to those who receive placebo. With the placebo adjusted weight loss, a 3.9 kilograms and a p-value of 0.001 at 22 weeks.

An important feature of Belanoff, Coral and, as how well it was tolerated in both grace and gradients.

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 hyperchlorosolum experience, following a rapid reduction in cortisol activity, whether due to surgery that removes an ACT-ach or cortisol screening tumor or the start of medical therapy.

As expected, there were no relevant and juiced instances of hypokalemia, andometriol hypertrophy or it's 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 hypercoursolism.

The Positive Efficacy and Safety Result remains.

Now supported by the Global Improvement Senior Patients in the Gradients Study, Promise a Great Advance for Patients with Cushing Syndrome.

Concurrent with our work on relic oral and new drug application, we continue to look to further increase position awareness and understanding of cushing syndrome.

Our Phase 4 catalyst study, a patient's with difficult to treat diabetes, has produced potent evidence to help advance the field.

Speaker Change: 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 hypercordersalism and was previously recognized.

of the first 1,55 patients enrolled in catalysts. One in four were found to have hypercortezolism.

Speaker Change: This is a far higher prevalence rate than was assumed with large implications for patient care.

Hiperchorus-Ollism 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 magnetic patients to manage their hypertension.

More than a third of this group of patients were found to have hypercoresolism.

Speaker Change: The second portion of the Catalyst study is ongoing. In it, patients with hypercours autism are randomized to receive either quarrel and 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 relic oral and as a treatment for different types of cancer mediated by cortisol activity.

In our pivotal Rosetta study, 381 women with Platinum Resistant Ovarian Cancer have been randomized on a one-to-one basis to receive either napaclataxle, a medication off and prescribed to women with Platinum Resistant Disease, or napaclataxle plus relic oralite.

Our expectation is that Relicorollin will resensitize ovarian tumors to the effects of chemotherapy by blunting the 8-ante apoptotic effect of cortisol activity.

Resellus Design closely tracks the design of our successful control phase 2 trial.

Speaker Change: in the Phase 2 trial, women who received relevant intermittently.

Speaker Change: 4, The Day of and the Day after they receive Nat Pakletaxil, Exhibited Statistically Significant Improvement in Progression Free Survival and Duration of Response, Compare to the Group who receive Nat Pakletaxil Monotherapy.

Women in the Rell Coral Inc. also live longer than those in the comparator arm.

Speaker Change: 29% of the patients who took intermittent relic oral and were alive two years after study start, versus only 14% who took napaclactaxial alone.

In importantly, the women who received Relicoral and plus Natpakletaxial experience no additional side effect burden compared to those who received Natpakletaxial alone.

We expect results to replicate these results.

In Roman and Rosela 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 Rosela in collaboration with leading clinicians from the gynecologic oncology group or geog in the United States and the European Network of gynecological oncology trials or end-got 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 Rosela to bring relevant coherence to the women who can benefit from it.

Speaker Change: Positive results will also prompt us to explore Relicoirland as a treatment for earlier stages of a very encounter and other solid tumors that express the glucocorticoid receptor.

Speaker Change: In addition to exploring its potential to resensitize tumors to chemotherapy, we are evaluating cortisol modulation's activity in two other mechanisms of action.

in Covenation with Andrew Jin, Deforestation Therapy, and Immunotherapy.

Speaker Change: Quarasal stimulation is thought to be a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist in dilutamide, eventually experience research and disease.

The Pride of Andrews and Stimulation, their tumours which the 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 ofbrella Coralent, plus in salute of mine, in patients with early stage prostate cancer. Before these patients had had an initial prostatectomy.

Speaker Change: Another potential role of cortisol modulation is in combination with immunotherapy. Because cortisol suppresses the immune system, it may blunt the effect of this of a cancer therapies intended to stimulate the immune system.

According to a major later to immunotherapy such as checkpoint inhibitors, may enhance their effectiveness.

Following our phase 1B trial and advanced adrenal cancer, we are evaluating next steps to further understand the role of cortisol modulation in combination with the immunotherapies in other tumor types and earlier stages of cancer.

Our research team has developed a library of more than a thousand selective cortisol modulators with distinct pharmacodynamic properties.

Speaker Change: Some are more potent and modulating cortisol activity across many tissue types, some are tissue specific.

Speaker Change: Summer very potent 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 dazz who quarrel at.

We have advanced NASA Coralant into clinical studies based on compelling data showing improved motor performance and reduced neural inflammation and muscular atrophy in a commonly used mouse model of ALS.

A randomized double blind placebo controlled phase two dazzles 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 gas equivalent, 300 milligrams of gas equivalent, or placebo for 24 weeks.

The primary endpoint is performance on the revised ALS functional ratings scale score and validated measure of the impact ALS has on patients. We expect to receive data by the end of the year.

Speaker Change: Mash, metabolic dysfunction associated stiato hepatitis is a serious liver disorder that afflits millions of patients in the United States.

Chorus-alm modulation may serve as an effective treatment for mash because Chorus-alm activity has been implicated in both the initial development and progression of the disease.

Our Phase 1B dose finding study of Miracore Island found the patients who received 100 milligrams orally just twice a week for 12 weeks, experiencing the 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis and key metabolic and lipid measures.

Speaker Change: Such as insulin resistance, serum triglycerides and LDL.

In importantly, Merrill Coralant was also very well tolerated with none of the GI side effects which commonly arise in patients being treated for mesh.

A randomized double-blind placebo controlled Phase 2B monarch study aims to expand on these encouraging results.

Speaker Change: Monokers and Rolling 2 cohorts. In the first, 120 patients with biopsy confirmed mash, a randomized 2-1 to receive either 100 milligrams of miracle-alent twice weekly or placebo for 48 weeks.

Speaker Change: The primary endpoint for this cohort is reduction in liver fat, but by obscene firm, mass resolution and fibrosis improvement, key secondary endpoints.

The second cohort has a planned enrollment of 75 patients with presumed mesh.

Speaker Change: Patience in this cohort will be randomized 2-1 to receive either 100 milligrams, Miracle Island twice weekly for six weeks, followed by 200 milligrams, Miracle Island twice weekly for 18 weeks.

Warpal Seaboe for the whole 24 weeks. In this cohort, the primary endpoint is also a reduction in liver fat.

This is an incredibly exciting time, a course set. Our commercial business is strong. The grace and gradient trial results demonstrate that we developed a distinct superior treatment for patients with cushion syndrome.

The prevalence results from our catalyst trial make it clear that there are far more patients with cushion syndrome than was previously assumed.

By the end of this year, we expect to receive treatment data from our catalyst study in patients with cushion syndrome, as well as results from our pivotal Rosalis study in a varying cancer and our dazzle study in ALS.

Positive results in these studies will be transformative for the company and more importantly, lead to great benefit for the patients we serve.

Every employee at Khorsep understands the importance of the work we do. We are driven to support as quickly and effectively as we can, patients with pushing syndrome and the other disorders where Khorsep's all modulation can make a difference.

Speaker Change: Operator, let's proceed now to questions.

Speaker Change: Freedbone.

Thank you at this time, we'll conduct the question and suggestions. As a reminder to ask a question, you'll need to press star 1 on a telephone and wait for you name to be announced. To withdraw your question, please press star 1 when again. Please stand by while we can talk about the Q&A roster.

Our first question comes from a line of David Anselam, a pepper standard, your line is not open.

Thanks, so just have a couple on the grading and data first. I guess I'm trying to better understand.

How to think about this so you have

I'm the blood pressure endpoint.

and the University of New York, you have the active drone service in placebo. That different was not statistically significant. I understand the different services baseline. But I guess my question here is how...

should one interpret that number one, just given the absence of separation, specific and 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 that and hand given that backdrop. And then I get the last part of the question is that is gradient.

We did a full approval, has your communication with the FHA, in supporting the world's greatest in the NBA.

Speaker Change: Thanks. Yeah, thank you, David. I think I understood all those questions and first I just like to pass you over to Bill Guy or Bill's Archie Pedeltman, Office for you, you've heard him on previous calls and I think he can answer your data question very specifically.

and I think I can thank you Dave for that question. I can hopefully address all your questions best.

So, you know, the most important thing to remember when you look at the gradient data is that as you 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 in other Phase Three studies, we don't talk about as much, but I will today, the Study 4-5-2, which is our long-term extension study.

All together, this gives us the largest NDA package for Cushing Syndrome, and we have hundreds of patients. So, going to the FDA with this large-for-package, no-ever company is 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 end even the gray strouler, all of our trials together, let me remind you that cushions is a syndrome. With many signs and symptoms, probably 20 or more signs and symptoms, and some high-potentional hyperglycemia are just two of those examples.

Speaker Change: When you look at the results from gradient, it supports the 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 an aim of you.

Speaker Change: Now when it comes to blood pressure and 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 hyperglacimia and points for fasting blood glucose, ac glucose and heat-agulment amency as Joe had mentioned. But also when we look at patients with either higher hemoglobin A1Cs and have overt diabetes, we see it even great response to all of those.

Speaker Change: And also when we look at all of the data, I'll tell you that Relicorlin produces a clinically significant, and statistically significant improvement in insulin resistance because we see improvements in AUC insulin and homoIR.

As well as when we look at other factors like coagulation factors, we see statistical improvements and coagulation factors all favoring in Rellacorlan.

And as well as Joe mentioned, we saw significant improvements in body weight and body compositions when we do dexascans, pastoral losing fat from the visceral area, which is the bad fat in the belly area, which is what we wanted to see.

So all together, this speak to the broad improvement of cushion 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 Rela Corlan, and known new safety signals were seen.

and the Greating Trial.

and I've got to reiterate because this is really important because it helps differentiate relevant from any other product, especially that of corollum. We see no reported cases of endometrial hypertrophy, with or without vaginal bleeding, no cases of adrenal insufficiency, no evidence of drug induced hypocholemia and no QT interval prolongations.

All of this is supportive of and some of that of what we saw in grace.

Now let me also come back to the other phase 3 study, the 245-2 of why I feel confident with the 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 and gradient and roll into this trial. And so we will see patients who have remained on relicorlant 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 relicorlin and will be able to evaluate their progression.

Speaker Change: 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 high potential response shows clinically significant and statistically significant improvements in both systolic and diastolic blood pressure at month six and it 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 relicorlin that will happen in the coming weeks.

Speaker Change: Thanks, thank you, Bel.

Next question please.

Next question, Councilor Lime of Matt Kaplan.

Speaker Change: is not open.

Speaker Change: That's what I'm hearing.

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

I'll try it out, okay.

Matt: So, yeah, thanks for taking question and thanks for clearing up the question on Greedy and that was very helpful already.

Results showing the prevalence in terms of additional screenings that are going on for to ID, identify patients with cushions.

Speaker Change: Yes, Matt, thanks very much for the question. I understand that and I think Sean Meduk, the president of our endocrinology division, is best prepared to answer that question. Go ahead, Sean. I'm Matt. Thanks for the question. And yeah, I mean, the short answer is yes, we are starting to see some impact from cattle that's been those results. I will say though that it takes some time.

For you know those results to roll into guidelines and to start practices and it's going to take some time to see the full effect. So our expectation is that we will see the full effect later into 2025 and beyond.

But 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.

Speaker Change: Now specifically why.

I'm really just getting started and at the front of the curb or that growth. Juan Joe mentioned in his early comments and that's that hypercrotosolism is more prevalent in one thought.

Speaker Change: and it's no longer considered an ultra-rare disease. There's been multiple studies in the last couple years, but if highlighted this fact, catalysts enforced it with the one in four number, and even the most recent FDA guidance in 2023 highlighted that the numbers bigger. So there's far more prevalence.

Matt: 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.

Matt: the Green 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, Coralum is a great product.

But Rolikarlan is going to be even better. It shows efficacy across multiple and all signs and symptoms of a fucishing syndrome as Bill just walked through and Joe walked through in his comments and has significance safety benefit.

Matt: [inaudible]

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 comes our line of some ramaqas of 18 hand right your line is not open.

Speaker Change: Hey, okay. Thank you. This is okay from Pennsylvania and we're a quick question on the Rosalda study.

So in the prepared remarks, I'm Joe, you're 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 20 week, 24 weeks study with a double blind period and you break the blind and you have the results.

Speaker Change: On college studies are a little less determined because you're waiting for a number of events to occur and you do your best calculation. Of course, we have done that. I'll give you back the ability to give you kind of specifics but understand that lack of specificity and when a result will read out for non-college study is just...

is a part of the course for oncology studies. But feel 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 Rallicorlant plus an apaclataxyl, a key thing that differentiates it, probably from any other...

Drug or Combination in Platinum Resistinal Varian Cancer is that we see a differential effect on duration of response.

Speaker Change: and that duration of response is what you're driving the PFS and OS benefit that we saw in phase two.

Matt: So if you model that out.

where we saw the greatest benefit in...

The Phase 2 trial is women who were living longer, especially two times the amount of women who were living longer, at year 2 for a relevant plus and a pack versus a pack alone.

Matt: Now we're replicating that in a study that is 2-3 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 Ralecrolant plus an attack of Axel. 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 year and an analyze that data as soon as we can to then talk about it publicly and presented it to the conference next year.

We will release that information. As soon as our analysis are done on Marquee, 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.

Speaker Change: Thank you.

for the call. Okay, sure. Next question, please.

Our next question comes a line of tune lead.

The line is now open.

Hey, okay, that's what taking our questions. Your characterization of gradient is since we had the supportive study while Grace is the pivotal. Is that due shared by the FDA?

Speaker Change: Yes, and I'd like to pass you over to Charlie Robb who handles all of our regulatory affairs, and I think it really provides some very useful color to you.

Hi, Jen. The answer is yes. And, you know, I think, you know, one thing I know, 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. There's published guidance.

and as well as any conversation to 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.

and Bill gave you really the strong clinical view. But I just wanted to underscore from the perspective of the person I have to go in with the team and present the arguments of the FDA, just what a good position we're in. We've studied as Bill pointed out, Relye Corlain, and more patients with Cushing Center, and then any other company with approved treatments out there. We have a tremendous amount of data.

Speaker Change: and our findings have been remarkably consistent from phase two to grace to our extension study and now to gradient.

Patients who receive Relicoral and got better across the entire range of cushing syndrome's signs and symptoms. It's really as simple as that. It's that easy and argument to present to the FDA.

and the Wemons of last interaction with the FDA and have already have a pre-NDM meeting with the FDA since like you're shining to submit the FDA within weeks. So it was curious if the authority had that conversation with the comment.

Well so you don't 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 R&DA in.

and I would want one more please. The hyperglacemia and point separate from the placebo, just one of the terrifying fabulous photos.

The answer is yes, I'm a bill. I'll just repeat the question.

Matt: Patients who were treated with relicoral and hyperglycemi endpoints separate from those who were treated with placebo. Yes, they were all statistically significantly different favoring relicoral and for all hyperglycemi 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.

and I'm looking forward to the full day of that 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 filed this for a long time. There's been no more exciting time of course that this is one thing so 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.

Speaker Change: Thank you for your participation in today's conference. This concludes the program you will not disconnect.