Q2 2023 Corcept Therapeutics Incorporated Earnings Call
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Now like to hand, the conference over to your speaker today, I debacle Corey C. F. L. Please go ahead.
Hello, everyone.
Afternoon, and thank you.
<unk> Chief financial loss.
Today, we issued a press release announcing our financial results for the second quarter.
Providing a corporate update.
Copies available at <unk> Dot com.
Financial results will be available when we file a Form 10-Q with S.
Today's call is being recorded.
Replay will be available at the investors ask the best half of our website.
Statements during this call other than statements of historical facts.
Forward looking statements.
Based on our plan for an expectation that our subjects to risks and uncertainties, which might cause actual results to differ materially from those payments express or implied.
These forward looking statements are described in today's press release, and the risks and uncertainties may affect them are described in the press release.
Annual reports and 10-K.
Hey.
Quarterly report on Form 10-Q.
Please refer to those documents for additional information.
We disclaim any attention our duty to update forward looking statements.
Ah revenue in the second quarter of 2023 was $117.7 billion.
An increase of 14% compared to the second quarter of last year.
To reflect that wrote we are raising our 2023 revenue guidance began to arrange a $455 million to $470 million.
Up from 435 to 455.
Net income was 27 and a half million dollars or 25 cents per share in the second quarter compared to $27.4 million or 24 cents per share in the same period last year.
Our cash and investments of $363.3 million at June 30th.
Flex the purchase of 6.6 million of course up chairs for $145.4 million during the court.
I will now turn the call over to Charlie Rob, Our Chief business officer to provide illegal.
Charlie.
Right.
In March 2018.
You too have a pharmaceuticals in Federal District Court medical marketing, a generic version of Portland in violation of our pets <unk>.
Trial is supposed to begin next month on the 27th of September .
As a reminder, that I do not dispute the validity two patents you're certain against it.
Four patties and the 800, Patton, which concern the Safeco administration of four of them the commonly prescribed class of drugs known as strong sabriya inhibitors issues.
Issues determinative of these patents validity were decided in our favour whichever lost the Postscript review challenge initiate it.
So it was the only defense with respect to these two patents that is proposed products would not infringe. The physician, we believe has no legal or factual support.
Two one for any other patents are two of the four patents we are asserting against.
As I said last quarter and then all of the calls we've held since this litigation began.
Our supreme confidence and strength of our case.
Happy that our trial date is approaching you'll look forward to our date of course why.
And the facts are on our side.
Naturally call over to Dr. Joseph spell it out or Chief Executive Officer.
Thank you Charlie.
Strong results of our commercial business in the second quarter reflect the early return on our substantial investment to stimulate physician.
Better recognize to treat hyper cortisol or something.
Second quarter, we saw a continued increase in the number of patients receiving Carla and a number of physicians prescribing the medication.
Business translation more panic patients benefiting from coral treatment as a new record high in our quarterly revenue.
We expect our growth to continue.
That's an excellent treatment for patients with Cushing syndrome, and there are many eligible patients who have yet to receive it leaving.
Leaving endocrinologist increasingly believed with your considerably more patience with pushing syndrome and was once assumed.
The results of our ongoing catalyst study likely provide further evidence to bolster disbelief and equally likely lead physicians to begin to identify and provide effective treatment or a large group of patients with hypercriticism, whose disease currently goes and diagnose.
We are confident in the growth potential of our Cushing syndrome business and Ah raising our 20 twenty-three revenue guidance range to get this.
This time to $455 million to $470 million.
We're also very excited by the potential of our clinical development programs since inception, our research and development efforts and built on the hypothesis.
Modulation can be a powerful therapeutic mechanism and many serious disorders.
Brian Terry compounds modulate <unk> bye bye.
<unk> glared receptor or G. R. The receptor, which is activated when cortisol levels are high.
Do not buy into the progesterone receptor and don't cost of a car loans are approved products serious off target effects.
Interestingly, while our compound.
Compounds modulate cortisone activity without modulating progesterones activity they are not identical.
Some cross the blood brain barrier, others do not separate for best and models of solid tumors, others or more potent and models of metabolic disease.
The tissue specific others have more global effects.
He used to burst qualities allow us to study a wide variety of disorders.
Currently we are conducting programs with three of our proprietary select a cortisol modulators <unk> and Miracle Bartlett and.
An ovarian adrenal and prostate cancer.
S Nash and of course Cushing syndrome, we have additional compounds in clinical in preclinical development.
In the next 12 months, we expect data from her Grace gradient, a catalyst studies submission of an NDA perrella correlate in Cushing syndrome <unk>.
Completion of enrollment of our rosella and dazzle studies and initiation of phase two be trial Cortland impatience with Nash.
This is a very exciting time for core set.
Where the Hell are you waiting <unk> for the treatment of hyper quarters awesome and two phase three trials Grace ingredient.
<unk> electric co dissolve modulator like Carla she uses it back by competing with cortisol glucocorticoid receptor.
Unlike Harlem it does not buy into the progesterone receptor P. R for sure. So design cause P. R related side effects, including termination of pregnancy, endometrial thickening and vaginal bleeding.
Different mechanism rella call. It also does not cause hypokalemia low potassium.
<unk> side effect experienced by 44% of patients and twirls pivotal trial.
<unk> is a leading cause discontinuation.
Coralline space to efficacy and safety data work compelling <unk>.
Patients experience meaningful improvements hypertension, and glucose control as well as in a variety of other signs and symptoms of Cushing syndrome.
There were no wrong correlate induced instances of endometrial thickening or vaginal bleeding and no drug induced hypokalemia.
The trial results were published in front tears in endocrinology in July 2021.
With enrollment and Grace complete we are focused on finishing the trial and appearing R. N D a which we plan to submit the second quarter of 2024.
<unk> has tremendous promise as a treatment for patients with all etiologies of endogenous Cushing syndrome, and we are eager to make it available.
A second phase three trial in Hypercard has all this gradient.
Studying relic or a lunch or faxed in patients, whose cushing syndrome is caused by any trina adenomas or adrenal hyperplasia.
Patients with this ideology Cushing syndrome, often experiencing less rapid decline, but their health outcomes up for including a higher risk of premature death.
We do not expect R. N D. A in Cushing syndrome depend on data from premium would you expect the state to produce valuable data about an ideology pushing syndrome affects many patients whose hypochlorous less frequently goes undiagnosed add and treated.
I'm pleased to announce that our cat on this study is progressing ahead of schedule.
<unk> is a 1000 patient as for trial examining the prevalence of hyper cordozar lives in patients with difficult to control type two diabetes.
Patients diagnosed with hyper <unk> catalyst study, we choose to enter a randomized double blind placebo controlled study of Carla.
Many independent studies conducted over the last 15 years have found that the prevalence in hypercard is always in patients with type two diabetes.
Actually higher than in general population.
The most prominent diabetologist, the United States help us design and are participating in catalyst, which would be the largest study of its time. We have received very positive feedback from bleeding endocrinologist regarding this study and expect to complete enrollment in the fourth quarter a bit ahead of our previous estimates.
Our apology program is testing three anti cancer mechanisms first postulated by investigators at the University of Chicago and later confirmed by other prominent researchers.
One mechanism is increasing a pop ptosis programmed cell death chemotherapy meant to induce in solid tumors.
What does it all works against the beneficial effects of chemotherapy Ah suppressing a pap test.
Are successful control phase two trial and women in the platinum resistant ovarian cancer. The addition of our selective cortisol modulator relic Portland enhance the effect of chemotherapy likely by glancing cortisol anti apoptotic effect.
<unk> provided meaningful benefit too many of the women in our study well.
Well these women's disease progressed on to our previous lines of treatment, including previous taxis.
On that appear to resent the types of the disease to chemotherapy is beneficial effects some women those.
Those who received <unk> car on intermittently.
Maybe for the day of and the day. After they received not Paclitaxel exhibit a statistically significant improvement progression free survival and duration of response compared to the group who received not paclitaxel mono therapy.
Women in the intermittent rella Coralline group also live longer than does she need to compare with a P value as it approached statistical significance.
I was just your date indicates the 29% of the patients who took intermittent umbrella Portland, where like two years after study star versus only 14% Paclitaxel alone.
Just as important the women, who received <unk> paclitaxel experienced no additional side effects burden compared to those you received not paclitaxel alone.
The results from this study were recently published in the prestigious journal of clinical oncology.
I've also been featured in podium presentations at the 2021 and 2022 European Society for medical oncology <unk> meeting and at the 2022 American Society of clinical oncology ESCO annual meeting.
Brazil, a confirmatory pivotal pivotal phase three trial and a root platinum resistant ovarian cancer is enrolling patients.
Zealous design closely tracks a phase two study and its goal is simply to replicate a positive phase two results in a larger group.
Enrollment is 360 women randomize, one to one to receiving your <unk> paclitaxel or nap appetite alone.
Primary endpoint is progression free survival with overall survival of key secondary endpoint. We are conducting a study in collaboration with meat and clinicians from the gynecological oncology group in the United States and the European Network, a gynecological oncology trials group in Europe .
We are on track to complete enrollment by the end of the year.
Leading gynecological oncologist told us that in their view <unk> potential benefit.
Prove progression free and overall survival without increased side effects burden constitute an important medical advance and <unk> plus nap paclitaxel has the potential to become a new standard of care and living with platinum resistance ovarian cancer.
Second mechanism by which cortisol modulation may prove useful cause my blocking an important tumor growth pathway.
Cortisol stimulation is a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist <unk> eventually experienced resurgence disease deprived of andreassen stimulation the tumor switch to cortisol activated to stimulate growth.
Our hypothesis is that adding a cortisol modulator androgen deprivation therapy.
Who's this tumor escape route.
Our collaborators at the University of Chicago plan to begin a randomized placebo controlled his two trial umbrella coralline essentially denied in patients with prostate cancer before the space to pattern initial prostatectomy this quarter.
Third of therapeutic mechanism seeks to treat tumors by enhancing the body's immune response.
Hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of these therapies. We are conducting a phase one be trial umbrella Berlin plus the P. D. One checkpoint inhibitor pimpernel isn't that in patients with advanced Greenall cancer Disturbers produce excess cortisol.
<unk> is rarely effective as monotherapy treating this form of adrenal cancer.
L S, commonly known as Lou Gehrig's disease is a devastating illness with an urgent need for better treatment dazzles.
198 patients randomized double blind placebo controlled phase two trial of tacit quarreling patients with L. S as briskly enrolling patients.
<unk> is a selective cortisone modulator did it show great promise in animal models of <unk>, improving voted performance and reducing neurula inflammation and muscular atrophy.
We are conducting this important study in collaboration with try cows bleeding a less academic consortium in Europe .
Recently added clinical trial sites in the United States and are on track to complete enrollment and dazzled by early next year.
Finally, I'll turn to our program in Nash serious liver disorder that afflicts millions of patients in the United States.
Mira Cortland and oral medication continues to stamina straight great promise as a treatment for Nash.
Prior Nash patience.
Patients received 600 milligrams per 900 milligrams of <unk> daily exhibited large rapid reductions in liver fat, but also substantial I'll be a transient elevations in the liver enzymes L. P N a S T.
Improvements in liver fat in these patients was greater than a card much more rapidly than he had expected and is rarely seen over any period of treatment.
Our ongoing phase one be dose finding study, which evaluated arrange a dosage and dosing schedules near Cortland founded patients who received just 100 milligrams a miracle aurulent orally twice a week for 12 weeks experienced in approximately 30 per cent reduction in liver fat and showed improvements.
Liver enzymes and markers of liver disease. These patients also have experienced improvements key metabolic unlimited niches such as home I R. Serum triglycerides in L. D. L. Importantly, miracle, that's very well tolerated we plan to submit these results for presentation at a scientific conference and will initiate.
A phase two be trial and the fourth quarter.
In conclusion, we are extremely optimistic about the future of course at <unk>.
Cushing syndrome business has tremendous growth potential and generate substantial profits even as we invest in alright dancing development programs. We are again, raising a revenue guidance for this year and anticipate growth for years to come.
A catalyst study holds great promise as the data generated will help physicians to improve the screening and treatment of patients.
Difficult to control diabetes is caused by hydrocortisone that sir.
Population is Christian syndrome frequently goes on diagnosed for these patients hydrocortisone is their disease and diabetes is a symptom of their hyper cortisol or something.
Our development programs are generating increasing evidence that validates our long held belief resolve modulation has the potential to treat you wide range of diseases.
Producing cortisol activity is straightforward and effective way to treat pushing syndrome and can offer substantial benefits to patients other serious disorders.
Aryan cancer L. S and Nash are current examples, but there will be others.
In addition to <unk>, we have many other proprietary selected <unk> and our portfolio with potentially very different clinical atrophy.
In the next 12 months, we will see data from her Grace Radiant and catalyst studies in Cushing syndrome.
<unk> N D. A in Cushing syndrome, and will complete enrollment in large controlled studies of platinum resistant ovarian cancer in a L. S will also begin a phase two D study in patients with Nash as.
As I said.
This is an exciting time for core set.
Thank our dedicated creative employees and layla investors for making that possible.
Stop your questions.
Thank you at this time it will conduct a question and answer session. As a reminder to ask a question you'll need to press star one one on your telephone and wait for your needs to be announced to withdraw your question.
One one again.
One moment, while we compiled a kidney roster.
Our first question comes from the line of Mac Caplin with <unk> Carolinas open.
Hi, good afternoon, and thank you for taking the question and the rats on a on a strong quarter uhm. Thanks ma'am.
Can you give us some sense in terms of.
What drove the revenues in the second quarter, and and and your confidence in and and increasing your guidance for this for this year as well.
Sure Ma'am I'm, just gonna interim reintroduced to the group of <unk>, who is the president of our Endocrinology Division in front of our Christian syndrome business.
Thanks for the question I'll I'll just start by saying, we're we're very pleased with the results. Your question was what drove it it was driven by improved access to unapproved feel of execution.
And we're starting to see some early returns from our investments many of our investments I've been on expanding the field and I'm working to get our field more productive and efficient. So I'll try that process. This order <unk> added both new patients and prescribers and we have more patients taking harlem than ever before does either warehouse continues to increase.
Really were more confident than ever about the potential size of the crushing supermarket for.
For the remainder of the year I mean at this point in our belief is just a fraction of hypercard of all locations have been identified and treated and over the coming months of quarters, there's gonna be many more.
Okay. That's that's helpful.
And just just looking at your pipeline with Grace and <unk> Grace completing enrollment and <unk> to complete in the near term.
Can you help us set expectations in terms of what <unk>, what to expect for Uhm Grace ingredient as I as I read out perhaps mixer.
Yes, let me introduce you again to feel guy or let's all of our develop your strategic development.
<unk> great. Thank you Matt for that question. So as we have now completed enrollment for the Grace trial. The investigators and we are very excited because of that and now we're in the plans of submitting that India and we've actually been working on that and da since last year and as we would collect collaboratively work with the F D. A.
We're gonna be working on developing and submitting all of our study showed that India.
<unk> many different thing I needed to include the full phase two data from a safety and efficacy perspective. The branch study from a safety and efficacy perspective, the grading trial from a integrated safety perspective, as well as our long term extension study, which has been ongoing for over five years, and we have patience umbrella cortland for doing well in for five years.
And then we're also gonna include many other new recently presented and published data with that I think we're gonna be excited to to include in the N. B a one of those big we just completed a thorough Q T study.
Reevaluated heart Q T interval and looked at <unk> and it sure no effects on the Q T at our home and that would make this the only drug and cushy syndrome that does not affect the cutie oedipal. So that's exciting news as we have completed that study. We've also seen published preclinical research, citing how Roman calling him uniquely shrink to we Terry tumors.
And tissue cultures and with those tumors. We've also seen him to publish case reports highlighting some other clinical benefit around the apartment and patience.
This is a differentiating factor because we have a Christian was also use the nose preclinical studies and saw no change and two theory tumors and then finally, we just presented them new data from our phase two trial looking at quack, Allopathy parameters, which was important because cushing syndrome patients or high risk for developing hypercritical apathy events.
<unk> Cortland showed no effects on those patterns.
Patterns and that would be again, the only drug and a cushy syndrome space to have no effect on hypercard gallazzi patterns all of the state. It makes me confident in the benefit around the corner of a can bring to patients and confident as we proceed.
A N D a and the next coming year.
Alright, and just just a quick follow up on that where are you with the the manufacturing manufacturing it all <unk>.
<unk> manufacturing it is not a rhythm extent Matt at.
Glue will certainly be ready to have commercial supply.
<unk> <unk> <unk>.
Alright, and one last question for me in the house on the back of the <unk>. The catalyst study will they had.
I had a plant do you have a sense in terms of based on the design of the study what percentage of patients that you're screaming have type of cough <unk> cough and in this business difficult to treat <unk> diabetes patients.
Yeah, Yes, ma'am <unk> I understand the question I'm Gonna hand, you back to Bill.
So catalyst is building on a tremendous amount of research already generated you with multiple different studies and I can cite all the studies and send you all the references many other studies run hundreds of patients and and in those independent studies over the past 15 to 20 years. We found that type of criticism is higher than the abnormal general population and I would guess.
Tomatoes to be around when you look at the average for those studies is about 10% to 20% for those patients who have gift to control diabetes and with catalyst. This would be then that landmark study because it is the largest study bitcoin evaluating a thousand patients to evaluate those with type two diabetes, who are difficult to control them. We're doing a simple task of just one <unk>.
T.
All of our investigators are part of this are highly motivated by this and that's why screening as to how to schedule and thus far and the catalyst study, even though it's early I would say that the results. So far are mirroring what we've seen in past published studies.
Alright, great. Thanks, So they had to call it yes.
Thank you Matt.
One moment for our next question.
Our next question comes from the lineup with.
Canaccord Your line is open.
Hi, Thanks for taking the call and yes, congrats guys on such a strong quarter really really great.
And you have to to to ask you and I guess, a skillful same vein a bit of it being a really strong quarter and and just the the additional and putting the sales effort truly kind of it does what should be tripped that too, but I see that the European society of into chronology has updated their practice guidelines on the treatment.
Adrenal into dilemma consent, it sent to the logos and I just wanted to find out what the what what the implications are there I think it's been awhile since you've you've been updated so just wanna kind of better understand what the implications could be there for for you sorta call them.
<unk>. Thank you for the question I'm Gonna directed to Sean again, Yeah. Yeah. Thanks for the the question I'm just adding on villages just spoke with their study. After study. After study has been mounting evidence overtime that this this illnesses is more prevalent and these European guidelines number just updated or just.
Another example of the evolution of the mindset are on it.
And they're gonna I'll, just recognize that I have your phone is all of them is more prevalent in one spot and what these guidelines do is encourage physicians to look harder for the disease, which is which is great. The guidelines also highlight the use of the relatively simple dexamethasone suppression test or D. S. T. A fantastic standard, which is gonna support and pre screening. So these guidelines will.
Influence and increase screaming and diagnosis my proposal.
Great. Thank you.
Thank you Edward one moment and the next question.
Our next question comes from the line of David insulin with Piper Sandler Your line is open.
Thanks, So just have a few first I wanted to ask a couple on mirror Cortland, and Nash and I know you're gonna have.
Got it in a medical meeting, but just thinking about the face to be can you just talk about the contours of the design of that trial is it.
Assuming we're gonna have liver biopsy as in this trial and is this is this something where you're thinking about is more of a phase two slash three and or is this something where we should think about it is.
You're still going to have to do a full phase three program beyond the stays to be that's number one number two is do you think about <unk> strategically.
Is this something that you're gonna look to partner down. The road is this something that you're going to look to Keith and commercialize and where does it fit in the the the broader business, particularly given the comments of that other cortisone modulators that you're looking at that you haven't disclosed thanks.
Yeah. That's it thanks, David and then two two questions I think I understand so what would your first described these to be you're calling studying and then I'll I'll I'll I'll describe I'll discuss the possibilities absolutely hey, Thanks, you for that question. So as we progress towards our phase two B program, let me back up a.
A little bit one we just completed a great advisor board at the E Commerce Witches European conference for studying liver disease, and we met with the top Herpetologist in the World who have done research for every molecule in the Nash page for the past decade, and I've known them for many decades as well and as we reviewed all the phase two a data for.
Our original study and all the phase two B R. A phase one b data they were really impressed with that and they help guide us in designing our phase two be trial and so that was really encouraging as we move forward. So that phase to be trout right. Now is our study as a biopsy confirmed nasty in patients with Nash. This study will be.
Double blind placebo controlled trial evaluating 150 patients randomized to.
<unk> 100 milligrams twice weekly for placebo for for you. Because this is intended to be a phase to be studying based upon those results. We will then progress and design a phase three trial.
And yeah. There's a second question is an interesting one and I just for a variety of reasons, particularly for those who are of course yep for a long time I mean as you know most of the things started with pushing syndrome doesn't work done had been orphan diseases niche markets, you know very obvious clinical need but two of <unk>.
Simply small group of patients Nash is of course, a different story.
The the number of people in the United States is Patty liver disease is very large S.
Besides what percentage of them have Nash progressive two worse things than that so it's a big market I don't know what the sort of the older term primary care market is the right way to describe it but there's certainly a market with many many patients Kenneth now that's a good question and whether we thought about a lot is is something that we can do what.
Around as we have with the other diseases, we've looked at or it's just it's just C space, where we need to partner I don't really know the answer to that at this point in time, but what I will tell you is that we are not in need of anyone else money to support the development plan. So if we decide to commercialization is better with a partner will go in that direction.
But I think we're really into lucky space because of our profitable business in our longterm profitable business. So we can take this is ours, we want and should we partner will be at a place where it's clearly advantageous for us to do so and you know I'll end it with a simple answer that decision has not yet.
Okay. That's that's helpful. If I might sneak in an additional question just on on catalyst.
As you get learning from from the study and and you.
Particularly the the answers that that you're looking for which is the Cushing syndrome and hypercard is all of them is more.
More prevalent in raising awareness among diabetologist do you think about calling on a sizeable group of Diabetologist in your roll out and and broader commercialization of <unk>. In other words is this going to be a you know.
A bigger splash, you're more expensive wider launch into a wider group of physicians. Thanks.
Sean Yeah no. Thank you for the question. Okay look we're in the process of.
Really working through that now to understand what the most effective way will be for us to watch road Carlin. We do recognize that these patients are in more than just enter all your practices by Patrologist in general are endocrinologists, but prescribed apologise showing up as a primary care offices sore throat throughout the country. So we are right now are are.
Working on trying to figure out scalable ways that we can get this message two two physicians so that they can be <unk>.
<unk> <unk> <unk>, <unk>, <unk>, but but just I appreciate the question Ah, David, particularly because we have been thinking about that.
I think at some point you know, maybe a decade or cause we thought that the patients.
Patients with pushing syndrome are likely to be treated by really a very very small number of endocrinologist. We do not think that is true anymore. We think it's their distributor to <unk> electric larger group and making sure that these patients get the optimum treatment is really that's <unk>. That's what we really want to get too so how it translates to <unk>.
Nickel matter.
Absolutely on our mind.
Alright.
Thanks, a lot.
Well, thank you did.
One moment sorry next question.
Our next question comes from the line that <unk> with the Bank. Your line is open.
Hi afternoon, everyone. So a couple from me maybe on taking on a question about your revenue guidance for a second I was curious what are some of the pushes and pulls that could get korlym revenues closer to the higher end or the lower end of this range and <unk>.
Sean I. Please take that yeah. Thank you for the question our guidance is pretty simple was driven by the number of patients on medicine, we have more patience taken problem than ever before and were you expected probably more in the future. We have a number of initiatives under way and we're expecting them to come back the second half of the year. So more patients that are prescribed call on the iron the end of the range of it will be.
At that service over pure it'll it'll be on the war.
It's really it's really as simple as.
There are other factors. Besides the number of patients that are really very appreciable.
Got it okay and wanted to ask a bit about your field force sign up <unk> you've reached the target of 60 are you thinking of possibly expanding that later this year or maybe into next year and what type of lunch metrics are you looking for to help you make that kind of decision.
Sean Please yeah. That's a great question I'll start by saying, we're always evaluating the effectiveness of a team and I'm looking to see what is the appropriate size that makes stepping back in time, a little bits of through the pandemic. We felt that it was very important for us to maintain the stability of that team, but over the last year. We've taken a very hard look at and that's where we've made changes.
Strengthening streamlined our training program with the goal of making our current clinical specialist more productive and our <unk> clinical specialist more productive more quickly and we've also I'm glad you just alluded to you added talk talk to the team. So in terms of the the current size of the team or actually currently in the mid fifties and we're continuing to add clinical specialist throughout the country.
Right now our target is 60, but we're unlikely to stop there. If we can continue to find top talent, we will be adding it to the team and as we continue to evaluate what the future looks like will determine if you need to go beyond that.
Got it thanks.
Thank you Rhonda.
One moment for our next question.
Our next question comes from the line of Jeremy with tourists to your line is open.
Alright, I've congrats on a strong quarter of text will take care of our questions.
Uhm I'm, particularly intrigued by your face for catalyst steady of Korlym is difficult to treat diabetics uhm, how are you, making a determination of hyper cortisone and advancing got into the randomized portion of the trial and how deployable is that screening for headquarters and by generalist kind of Chronologist, who treat diabetics and lastly.
What is the point in the randomized portion and is a part of resolved there sufficient to get a label able to vacation for diabetics I'd have a follow up.
Yeah, we'll put you first welcome or welcome back nice to hear from you and I think that Bill is best that's got his arms around I think all of that information, So I'm gonna turn it over to him. So.
So thanks for the questions. So when we look at catalyst, we designed it specifically again and and collaboratively with top Diabetologist sent to print off just to make this as simple and easy as possible and it's now a line with the guidelines as we spoke about earlier, we've just uhm deployed a simple test <unk> suppression test and looking for those pecs.
Since we're the D. S T credit at the 1.8 those are the patients were then positive then can qualify and be screened for are enrolled into the random <unk> placebo controlled trial of Korlym.
In that trial. The primary endpoint is just to look at the difference between glucose control between Korlym and that off the female and that will be our primary endpoint and related to will it change the label with Korlym Uhm.
It's already consistent with a label with corner because when you look at the Korlym indication quantum is indicated to control hyperglycemia secondary to hydrocarbons Elizabeth in adult patients with endogenous pushing center, who have type two diabetes.
Excellent thank you and.
I think that's just another small question, which was is that is the text message depression test something that doctors unusual practice can undertake the answer's, yes, not a heartening.
Great. Thank you.
So if if if catalyst positive, which would need to run a child <unk> difficult to treat diabetics to get the similar use commercially at.
You know, it's not either way actually you know with with dosing take different.
Or some aspect of the drug pick different between you know the Christmas patience and diabetics to maybe get different pricing given the different.
Yeah.
I just wanted to make sure to clarify this all of these patients disease is hyper cortisol and diabetes. Your glucose intolerance is secondary to their hyper Chris all so it is what is causing their I prefer solids, so and sometimes there's no difference except for degree of <unk>.
This between these patients and some of them actually can be quite <unk>. So I just wanted to make that distinction. This is not diabetes in general these medicines, whether it's <unk> or not for diabetes in general it for the treatment of hyper Coors all of them were diabetes appears as a prominent manifestation of my prefer solids.
And then to answer a question about what do we need to use round. The Carlin I see no reason to repeat this study I see this catalyst as a landmark study that would easily apply to <unk> and I'll remind you rollick korlym, we're looking for an indication of full indication for hypertension and diabetes nauseous diabetes.
Alright, looking forward to a progress data.
Thank you too.
One moment for our next question.
Our next question comes from the line <unk> Kenneth.
H C rain right to your line is open.
Thank you this is okay from Pennsylvania.
Good afternoon, Joe I'm Outta back high RK.
Okay.
Most of my questions have been answered that that I have a quick question on clinical data expectations for the rest of the rest of this year.
[noise], Oh, I'm, sorry, I didn't quite understand your question RK apologize Sir so so I'm just trying to understand what sort of clinical data could we expect this here.
You know from here to the end of the year.
Yeah, I'm going to turn you, though I know I understand your question Bill would you. Please answer that so as I look at all of the studies that are ongoing the one study that I can see that we are planning to submit to a conference in the fourth quarter of this year would be the Nash phase one D data and so that is our plan up to present that data hopefully at that conference catalyst there'll be close.
We're ahead of schedule I would say, it's probably first quarter of next year, but I could we could see results from the screening and prevalence study later this year in December .
Yeah, I'm just I'm just gonna underscore that I think what you can count on is the phase one be resolved Nash, we will have that but everything else falls into the next year off in the early part of next year, but in 2024.
Thank you.
Oh.
One moment, Sir next question.
Alright next question comes from the line of Alan <unk>. Your line is open.
<unk> congratulations on the <unk>.
Well it sounds like a wonderful.
<unk>, what do I do to help you with today.
Wow <unk>.
What's it called the calls about the dynamics of <unk>.
<unk> <unk> <unk> <unk> <unk>.
Okay.
Level of over for Ya.
Yeah.
A I I I apologize, it's a poor connection if somebody.
How did you put your balance question.
Okay.
I couldn't hear how may suck on I really apologize sound really just put in here.
Oh, sorry about that yeah.
<unk> yeah.
Yeah, but that's <unk>.
Yes.
Okay, what can you tell us.
<unk>, what can you tell us about what you've learned about the dynamics of call it what safety and efficacy of Elizabeth.
Okay, I'm gonna repeat the question.
<unk>.
<unk>. The question was what are we learned about the dynamics Miracle moment in terms of ethics and safety <unk> could you. Please talk to that key pieces. There you know we we've we've reviewed the phase two way data again, using 609 hundred milligrams, where we saw those dramatic fat redact liver fat reductions in a month corresponding with rises in never enzymes.
And that's what allowed us to then explore various lower doses and different dosing regimen, some face <unk> and as we have studied various different dose regimens, we really have to terminate Kennedy of fat reductions and we we confirm that one were reviewed all the data with our top advisors just about a month ago.
And we have determined that that labour fat <unk> rapid.
Reduction in liver fat is tied to that rise and increasing free fatty acids, which then causes <unk> dysfunction, which then in turn caused that never enzyme irritation in elevation and that's key because what we also size as it's a liberal trying to metabolize all those free fatty acids. It actually can metabolized.
Because we're not seeing any dumping a fat into the into the bloodstream. So weird because in our study we're seeing lowering effects on triglyceride.
L D. L. M. P. L D L. But importantly, we also saw that if we can slow that down and we saw that with the 100 milligrams twice a week dose that when we slow that down we see a steady decline up to 12 weeks and we saw that 30 per cent reduction in liver fat with no fries and out to your <expletive> T. We.
Actually start decreases my grandsons since so that's really what we've learned and we've done many analysis looking at the slip of decline percentage of decline. It all matches up that it really is tied to the <unk>. They prefer that reduction and we believe we've solve that problem, which is why we're going to phase two V.
Oh really.
Next set of questions.
<unk>.
Three program, which has.
Have the greatest zapping understanding from your audiences that'd be kind of go there and go.
Wow, we have a little chasm in education do feel free to <unk> versus the lifestyle specialist.
<unk> <unk> <unk>.
Yeah, No I've always wanted to repeat your question as I understand it which is you know all of our programs, which do we sort of least recognized by the investor community and yes. If that's really a distillation of your question, Yeah, I I I I I get it because I think one of the things that's surprising I think the people until they.
Really dig into the science and as you know you know sort.
Sort of a recovering academic so I'm really all about the side [laughter], how broad a platform cortisol modulation is cortisol goes into every tissue body. So it really has the potential to affect many disease states S. Some sense obvious why drug like <unk> or <unk> would be a.
Active in Cushing syndrome, I think it's initially a little less obvious why it might be effective in a neurologic disease like L S or disease like.
Cancer, you know variety of cancers, but I think that the interesting thing for US is that there are individual investors who seem to appreciate kind of individually parts of the story, but I think that there are few and I think this is gonna change over time really understand global application of course.
Modulation to the whole platform. So I don't think it's a question of any individual program, particularly being unrecognized I think that it's just that some people recognized <unk> ma'am. Some people recognize another program and I'm really hoping to see over time is that people can actually connect all those things because they really are connected and it'll give you just one.
<unk> personal example appointment has been you know every four years, we conduct a conference all of our collaborators. Since you know we have many academic collaborations at any given point 35 or 40 of them.
<unk> and they're all over the world in preclinical and clinical and we bring those people together since you said one time you know.
Many times they are unaware of do other work with people who are doing even though they are all working and cortisol modulation.
Our mission to make sure that people really understand this entire platform and I hope that as I said, even investors going nowhere are busy people really take the time to appreciate the global potential of these programs.
Well, thank you very much.
<unk> <unk> for both of Us.
Okay. Thank you very much Alan and I think with that we're we're out of questions. So look forward to talking to everybody three months from now and hope you enjoy the rest of your summer.
Thank you for your participation in today's conference. This does conclude the program you may now disconnect.
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