Q3 2022 Corcept Therapeutics Inc Earnings Call
Good day and thank you for standing by welcome to the course up Therapeutics Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during that Sir.
<unk> really depressed stellar one one on your telephone and you then hear an automated message advising that your hand is raised please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today <unk> C. F. L. Please go ahead.
Good afternoon, and thank you for joining us I'm out of whack Mccarty of course, that's the chief financial options.
Today, we issued a press release announcing our financial results for the third quarter and providing a corporate update.
Copies available at <unk> Dot Com, a complete financial results will be available when we file a Form 10-Q with S. D C.
Today's call is being recorded.
They will be available in the investors past events tab of our website.
Statements during this call other than statements of historical facts.
Looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to differ materially from those such statements express or implied.
These forward looking statements are described in today's press release.
Risks and uncertainties that may affect them are described as a press release.
In our annual report on Form 10-K quarterly reports on Form 10-Q.
Refer to those documents for additional information.
Disclaim any intention for duty to update forward looking statements.
Our revenue in the third quarter of 2022 was $101.7 million compared to $96.1 million in the third quarter of last year.
Net income was $34.6 million for 30 cents per common chairs in the third quarter compared to $35 million for 24 cents per comfy chair in the same period last year.
Catherine investments September 30th is $401.2 million, an increase of $19 million in the court.
We expect our revenue growth to continue and have tightened our 2022 revenue guidance to $400 million to $410 million.
I will now turn the call over to Charlie Robb R. Cheap business officer to provide an update on our litigation with generic manufacturers, Heather and Hikma pharmaceuticals.
Really.
I have little to report.
In March 2018.
Federal districts work to prevent it from marketing a generic version of Harlem in violation of our pets.
That lawsuit is still underway.
Although there has been no activity for more than a year.
Second quarter of 2021, we filed for some reason judgment based on having some infringement of our 2014, Pat Travers expected responded by balance awesome Rebecca.
Sorry judgment as a procedure whereby courts decided a case without a trial.
Court is not responding to these motions.
Remember the temperature orange the validity of the two.
One four patent it as the basis of our survey.
The patent office and lost which means it cannot charge that you want for <unk>.
District Court.
As a result is only defense to our summary judgment motions that is proposed product would not infringe.
Physician, we believe has no support.
According to size, depending summary, judgment motions and our faith that won't be barge marketing generic korlym until 2037.
For patent expires.
<unk>, we will proceed to trial most likely sometime next year, there's no timetable for the summary judgment motion.
No trial date, no schedule for any trial related activities.
March 2021 <unk>.
Pharmaceuticals discovery in that case is scheduled to conclude in April 2023, no trial basement.
With respect to both.
<unk>.
Now turn the call over to Doctor just spelling of our Chief Executive Officer.
Thank you Charlie.
Ah Christian syndrome business built on a solid foundation.
Setting medication promoted by a commercial team that puts the interests of patients burst.
Diagnosing and treating patients with a complex disease. So just pushing syndrome requires frequent and paid in person contact.
Revenue in the third floor was affected by fewer than expected in purchase interactions as many physician practices have not returned to pre pandemic patterns of activity.
To reflect this near term challenge, we are tightening of 2022 revenue guidance 404 extra $10 million.
Extremely optimistic about depression, and the future of our questions syndrome business quarrelled as an excellent treatment for patients with <unk> syndrome, leading endocrinologist increasingly believe they are considerably more patience for fishing syndrome and was one soon.
We are making substantial investments to improve the screening and treatment. These.
These patients and we have confidence decent initiatives will contribute to our results gonna come in quarters.
We are also very encouraged by the potential of our clinical development programs are clinical trials continue to advance generate data supporting cortisol modulations broad therapeutic potential.
Very excited about our most recently.
Studies Rosella.
Our confirmatory phase three trial and phone number just no ear ache cancer and death.
A phase two trial and L. S. We also looking forward to important readouts from our two phase two trials any anti psychotic weight gain by the end of this year.
A portfolio of more than a thousand proprietary molecules together with funds provided by our commercial success will allow us to further broaden our therapeutic areas of interest.
All of our compounds modulate cool resolved sex I binding glucocorticoid receptors or G or did you not find you the progesterone receptor so don't call Center.
Are approved products must series off target effects.
Interesting well all of our compound modulate for assault activity without modulating progesterones activity.
Not identical.
Some cross the blood brain barrier, others do not perform best in models of solid tumors, others or more potanin models metabolic disease, some appear to be tissue specific others have more global effects.
These diverse qualities allow us to study a wide variety of disorders.
Currently we are conducting programs and ovarian adrenal and prostate cancer.
L S anti psychotic induced weight gain Nash and of course Cushing syndrome.
We are also investigating cortisone modulation swollen and other diseases and an additional compounds clinical in preclinical development.
Cushing syndrome business is splendid all of these activities and will continue to do so.
Oncology 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 of chemotherapy is meant to induce solid tumors.
Cortisol works against the beneficial effects of chemotherapy I suppressing a pop toast.
And are successful controlled phase two trial.
Resistant ovarian cancer. The addition of are selected cortisone modulator rella cortland enhance the effect of chemotherapy likely by blood cortisol anti apoptotic effects.
<unk> breathed provided meaningful benefit too many of the women in our study.
While these women's disease progressed on two or more previous lines of treatment, including previous taxis.
Coralline appear to reset to tie some of them chemotherapy beneficial effects.
Those who received <unk> intermittently the day before the day of and the day after they receive paclitaxel exhibited a statistically significant improvement in progression free survival and duration of response compared to the group will receive paclitaxel amount of therapy.
The study was not power to show it to you mentioned overall survival or less compared to nap Paclitaxel monotherapy women in the intermittent <unk> also live longer than those thinking terror groups with a P value that approached statistical significance.
Mind, you that to date no approved therapies have demonstrated an overall survival benefit to patients with platinum resistant ovarian cancer.
In addition, the women who received <unk> snap paclitaxel experienced no additional side effects burden compared to do as you receive paclitaxel.
The results from this study room featured multiple podium presentation at the 2021 of 2022 European Society for medical oncology is Mel meetings, and it's a 2022 American Society clinical oncology <unk> annual meeting.
Rosella are pivotal phase three trial.
And ovarian cancer is active in enrolling patients.
Ellis design closely tracks a phase two study what plan enrollment of 360 women Randomised, one to one to receive either <unk> paclitaxel or nap Paclitaxel alone.
The primary unpolite will be progression free survival with overall survival of cheese secondary endpoint. We're conducting this study in collaboration with leading clinicians from the gynecologic oncology group in the United States and the European Network, a gynecological oncology trials group in Europe .
Are all in phase three simply to replicate are positive phase two results bleeding.
Bleeding gynecological oncologist told us that in their view relic or less potential benefit improve survival without increased side of at Burton would constitute an important medical advance and then <unk> paclitaxel has the potential to become a new standard of care and women with that number just ovarian cancer.
Second mechanism by which cortisone modulation may prove useful is by blocking an important tumor growth pathway.
Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist <unk> eventually experienced researchers disease deprived of the androgen stimulation tumor switched your quarters all activity to stimulate growth.
Our hypothesis at adding a cortisone modulator to androgen deprivation therapy, we close this tumor escape route next.
Next year in collaboration with the University of Chicago, you will be getting a randomized placebo controlled phase two trial umbrella or one plus <unk> in patients with prostate cancer early in their course of treatment before they have had their process.
Is there a mechanism of cortisol modulation seeks to treat tumors by enhancing the body's immune response cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapy intended to stimulate the immune system.
A hypothesis is that adding a cortisone modulator to immunotherapies. So just check point inhibitors may increase the effectiveness of those therapies.
We're conducting a phase one V trial umbrella Aurulent plus C. P. D. One checkpoint inhibitor capitalism, ma'am merck's drug keytruda in patients with advanced adrenal cancer, whose tumors produce excess cortisol.
These patients.
Suffer the effects of adrenal cancer, and Cushing syndrome, usually quickly lethal combination.
Timbral. This Amanda alone is rarely effective in treating this form of adrenal cancer.
<unk> trial is evaluating with a <unk> can treat these patients Cushing syndrome, I, reducing access code is all activity and Ah reversing cortisol induced immune suppression.
Allow kimbrell this map to achieve its full cancer, killing effect.
The primary appointed to study is subjective response rate secondary endpoints, including progression free survival duration of response and overall survive.
Well now I'll provide an update on our <unk> program.
<unk>, commonly known as Lou Gehrig's disease is a devastating illness with an urgent need for better treatment.
We are excited that we have initiated dazzles 198 patients randomized double blind placebo controlled phase two trial <unk> in patients with a L. S.
As a corollary to select a cortisone modulator. It crosses the blood brain barrier and has shown great promise in animal models L. S.
Proving motor performance, and reducing inflammation and muscular atrophy.
We're conducting this important study in collaboration with try cows bleeding a L. S academic consortium in Europe .
Next I'll charge more programs and metabolic disease, which will produce important data suit.
We're conducting two double blind placebo controlled phase two trials mirror correlate gratitude and gratitude to impatience with anti psychotic induced weight gain.
A serious and widespread disorder.
And I did state 6 million people take anti psychotic medications, such as Olanzapine in risperidone to treat illnesses, including schizophrenia bipolar disorder and depression.
He shrugs Barry affected the often cause rapid and sustained weight gain as well as cardiovascular and metabolic disease burden on patients as severe.
Average life expectancy agents in the United States, you take anti psychotic medication chronically, let's decreased by 20 years.
The side effects also just wait many patients from adhering to their treatment regimen.
The gratitude trial seek to build on the positive data from our studied Miracle Bartlett and healthy subjects 2020, we completed a trial in which 96 healthy subjects, receiving olanzapine 8600 Miracle milligrams of <unk> 900 milligrams.
Or a placebo for 14 days.
Perfect you receive americorps alinsky significantly less weight than those who received placebo. They also exhibited a smaller increase and triglycerides in in the liver enzymes L. T. N E S T, which typically exhibit sharp transient increases at the start Olanzapine therapy.
Paper, describing these results was published last year in the journal of clinical Psychopharmacology.
Gratitude is evaluating whether miracle orlin can reverse recent anti psychotic induced weight gain and gratitude to is evaluating reversals long standing anti psychotic weight gain.
The primary endpoint in both studies is production body weight I also want to stress the importance of general improvement to the patient's metabolic health as an indication of the patient's condition be treated more fully.
For example, improvements and lipid glucose control and markers liver hell would be highly desirable outcomes.
These studies will produce important data in many areas and we look forward to the results by the end of this year.
We were coralline is also our Kennedy treatment for patients with Nash serious liver disease that afflicts millions of patients in the United States.
Prior Nash study patients who received <unk> exhibited large rapid reductions delivered that but also substantial I'll be a transient elevations and liver enzymes D. N E. S T E.
The improvement he'll never fat in these patients was greater than occurred much more rapidly than we had expected and is rarely seen over any period of treatment.
Patience exhibited reductions in liver fat ranging from 38.5% to 73.8% after receiving your equivalent for just one month.
To put this in perspective recall that the trials primary and plan was a 30% reduction that after 12 weeks.
It may be that the rapidity of mirror correlates that reducing it that caused the patients L. T. N E. S. T arise one way the liver shifts bad is by metabolize against fatty acids, which in excessive amount yorkie deliver.
<unk> in the blood of these patients did not increase providing support the idea that you're calling cause excess fat to be metabolized immediately within the liver.
The goal of our phase one vetoes finding studying patients with Nash is to identify dosing regimen captures the unprecedented repeatedly and magnitude live or back reduction without causing excessive literary irritation.
Rolling of this trial has been robust and we plan to share its results in first half 2023.
Finally, as most of you know we are evaluating <unk> plan successor to call in for the treatment of hyper cortisol isn't into phase three trials Grace and greed.
<unk> is a selective cortisol modulator like call them and cheese in the back by competing with cortisol <unk> receptor.
Unlike orla does not find you the progesterone receptor PR sure and so it does not cause P. R related side effects, including termination of pregnancy, endometrial ticketing and vaginal bleeding.
By a different mechanism rather call. It also does not appear to cause hypokalemia low potassium serious side.
Experienced by 44 per cent of patients in Orleans pivotal trial.
<unk> is a leading cause korlym discontinuation.
Well look Orleans phase two efficacy and safety data withdraw.
<unk> experienced meaningful improvements in hypertension glucose control as well as in a variety of other signs and symptoms <unk> syndrome.
No <unk> induced instances of endometrial take any vaginal bleeding and no drug induced hypokalemia.
Trial results were published in frontiersman endocrinology last year.
Racist enrolling patients with a theology of pushing syndrome and is randomize withdrawal trial design. All patients initially received <unk> for 22 weeks and open label part of the study there.
There was a meat response criteria a randomized to continue treatment rella cortland or placebo for 12 weeks.
We had our investigators are eager to take race to the finish line, we expect grace to serve as the basis for NDA submission Cushing syndrome, which we expect Smith and the second half of 2023.
Our second phase three trial gradient studying relic or a list of facts in patients who just Cushing syndrome is caused by an adrenal adenoma or adrenal hyperplasia.
Patients with this ideology pushing syndrome, often experience a less rapid decline, but their health outcomes are poor.
<unk> is the first controlled study in patients with this type of Cushing syndrome.
While we do not expect R. N D a and cushy syndrome to depend upon data radiant, we do expect that its findings will help improve the care of those increasingly recognized patients.
<unk> a randomized placebo controlled study is a plan enrollment of 130 patients.
Sure a commercial business continues to generate substantial profits even after funding all of our development programs. We are extremely optimistic rescue feature of our Cushing syndrome business.
Significant investments to improve the screening and treatment of patients with <unk> <unk>.
We are confident that these initiatives will contribute to our results in the comic orders and expect a revenue to continue.
Our development programs continue to generate evidence validating our long held beliefs that cortisol modulation has the potential to treat a wide range of diseases.
Producing cordozar activity straightforward and effective way to treat pushing syndrome. It is.
Clear that excess cortisol activity, that's other very serious disorders cortisone modulation can provide substantial benefits.
Berrien cancer is a prime example that there will be others.
Just open most multinational trial and <unk> and we will have important data from our anti psychotic waking studies later this year at the net from our National program in the first half of next year.
A whole academics deal and the use of cortisone modulation.
The hall and other addictions is opening in.
In addition, and in addition to relic Cortland Mirror Cortland and <unk>, we have many other cortisol modulators in our portfolio with potentially very different clinical atrophies.
Of course, it steadily advancing across multiple fronts. Thank.
<unk> are dedicated creative employees and our loyal investors for making this possible.
I'll stop here for questions.
Thank you at this time or 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 then wait for your name to be announced please stand by <unk> <unk> Sir.
Mmm.
Yeah first call comes in the line is at Nash.
With.
Your line is open.
Hi, it's actually Edward <unk> Court, Thanks for taking my call and I really appreciate the overall pipeline overview.
Just wanted to touch on a on a point Joe that you brought up the beginning of your of your comments just talk about the the limited interactions are still occurring uhm at the Doctor's office, there and I just wanted to kind of understand it.
Better understand that because we're we're clearly not in the in the peak of Covid anymore, now and things are relatively gotten back to normal but it seems that a lot of the doctor's offices. If they are still doing virtual it's because of their choice or pace of choices. So I just wanted to understand just kind of what is going to be the pushed too.
To to kind of get things back toward they need to be patient.
Patients really having a hard time getting appointments with with the endocrinologist to to.
Either for follow up or or is it the lab issue or just I'm just trying to understand that there's a lot of moving parts, but.
Kind of what is kind of the the.
The the overall stop gap that truly causing the problem here on on growth of Korlym.
Yeah.
<unk> I think we really do understand your question and I just wanted to re introduce you to <unk>.
<unk>.
Intrapreneur allergy division and one's all of our commercial activities I think you can really.
Give you a detailed answer to that question yeah. Thanks for the question again is just David interactions really the amount returned for us to pre pandemic levels.
Right now we're not sure if they ever will.
The company spent a lotta time.
Educating them on disease, and a physician's aren't aware or that's awesome, they're not aware that it can be a source of officials comorbidities. They don't look for a screen for it. So we work hard and will continue to work hard to find new ways to operate perceived to be this this new normal for you to innovate and I'm confident that we'll continue to find that new incredible.
To reach our target audience.
Part of your question was around although or not maybe in the iron the pandemic some practices and <unk> help groups.
Maybe you weren't always up to seem clinical specialist in the past I would say somewhat taken advantage of of the change of the situation now and what is your daughter's too far suitable reps, which is a shame because a lot of newest the newest information in science actually blood advice.
Yeah, and what I, what I'm really just like to answer the question just just really give you the <unk>.
All around it is that I agree with you you know when I'm out now it seems as if that many things are back to pre pandemic normal although not entirely and I think.
Physician myself I can tell you that there are many doctors use practices have changed in character <unk> to some degree now our major effort in terms of sales really always relied on particularly at the very beginning before a physician had prescribed many in person sessions as personal as educated with Dr dedicated over pier.
We have time before they began screening, but I think the reality is that while many practices in some ways. It returned to normal I think that other practices may not ever return to what was it like pre pandemic, that's really on us to figure out ways to make sure that education process continues in this new way and I'm really I'm very confident that we have we have reached.
Specific ideas of how to do that but we're now accepting that this is how the world is gonna be billing forward and we're gonna operate from that perspective.
Great. Thanks, so much.
Okay. Thank you one moment for our next question.
Which cancer in the line of.
Dennis Gang at Jefferies. Your line is now open.
Hey, guys. Thanks for taking the question two questions for me if I may number one.
You can look at the business for a big picture perspective, maybe talk about your commitment and importantly.
Importantly, visibility and continuing to achieve a double digit growth <unk> profile as we look towards 2023 and afterwards and.
Then number two maybe come in on the L. T I caught it can do weight gain.
<unk> some data by your and remind us what with all of you showed on per cent weight loss and the level of a ticket for you hope the fee for a phase two study.
And maybe to follow up on that what opportunities to see outside of a R. W. G and Nash and I'd be curious to get your gun the broader applicability and much larger market.
<unk> two two super in areas questioning so let let let's go you know one at a time the first question I'd like to.
Waits too hyper cortisol as I'm in or commercialization effort I'd like to give you back to Sean Yeah. Thank you for the question and I want to remind everybody about the.
Significant growth potential that existence, Margaret I mean, there is now a substantial amount of independent and a bit of research that suggested hypercritical wisdom is.
Essentially farmer prevalent previously fought stolen.
Stolen or disease, but cause there'll be 30 to 40000 patients, yes, and we're focused on a marking up old password. So despite all these current challenges that we just went through and we're confident in our path to Saint <unk>, but I thought I'd, maybe take a minute to tell you a little bit about what a couple of those two strategies are we we talked about how access has been so one.
A R. T focus areas is to increase physician interactions in order to do that by increasing the size of our customer customer facing team and the support groups around that and working to improve the productivity.
The second big focus area for us, it's really around interesting screening of recall right by raising awareness and specialties that we believe have a rich patient populations. So I'm gonna give you a couple of examples for example, number one primatologist see a large number of treatment resistant diabetics, yeah. They do not routinely screen percussion Cassandra even though.
Literature states that anywhere from eight to 10 per cent of this population may have underlying our proposals.
Another example, radiologist frequently discover a drill nodules drink routine abdominal yeah. It's over those patients are often not refer to an entrepreneur I'll just work, even though radiology guidelines that they should be so not all specialties are aware of hypercard was all of them and because of this many patients go undiagnosed and we're very focused on I'll change that we're gonna use <unk>.
Getting channels as Joe mentioned to get the message out to these customers through <unk> and digital means not all these patients will be crawling candidates, but somewhere else and it's really the sum it up all of our strategies and tactics are focused on increasing physician interactions raising hypercard has autism awareness increasing patient screening.
Most importantly, improving care for <unk>.
Right and then and then it's your second question has to do with our anti psychotic induced weight gain program and I'm Gonna turn it over in a second to a bill Guy or who is Archie development officer and responsible for all of the drugs to develop including anti psychotic. This weekend, but just one small point uhm it but I think it's an important one you mentioned that will Bobby.
Just just a factual point is obvious for the prevention of anti psychotic and <unk> in fact, olanzapine induce weight gain but not for not for weight loss I think that's an important distinction. So I'll turn you over now to bill and she can give you an answer to up your variety of questions and thank you very much.
<unk> regarding our anasarca reduce weight gain focus it's from the gratitude and gratitude two studies and yes, we will have data by the end of this year and we expect and evaluate both of those studies individually, but also collectively pulling the data does this make sure we fully understand all the data from these trials because we really think that we've got a <unk>.
Holistic review of all of the data and I enjoyed stated earlier, we want to make sure that we analyze the data not just on the primary purpose of weight gain but also all of the other metabolic factors and.
In addition, importantly psychiatric measures and so that's gonna be our focus is to make sure that we fully understand all of that data because we believe let me produce the results and we communicate those results we want to make sure that we're clear or we understand and therefore, you understand the benefits <unk> can bring to these patients.
Okay see I think tennis you also ask a question about the larger issue wait.
Wait maybe weight loss in general and I just wanted to make sure all the listeners know that we we have no programs weight loss as a entity is really is about the specifics of <unk> patients who have gained weight by taking anti psychotic medications medications like lands have been a risk per dollar seroquel mask, where we're aiming right now it's a very different pro.
Graham to consider for weight loss in general.
Next question. Please yes. Thank you. Our next question comes from the line of <unk>.
<unk> <unk> your line is now open.
Greg Fisher Your line is now open.
Sorry. Thank you thanks for taking the questions and good afternoon.
Alright.
Quick follow up on mere Portland, It sounds like it will be when you made the announcement you'll be providing.
A lot of quantitative.
Results from this study to help investors assess uhm, yeah, I'll kind of is that.
If the right way to think about it.
Yeah, <unk> <unk> as you know or the first studies, we built with <unk> in anti psychotic induced weight gain reversing anti psychotic do sweeping and we think they're gonna provide a very rich data set which will indicate our best path forward.
Got it okay <unk>.
<unk> and the guidance and the growth in 2022, and what's with the growth is driven by new patients versus price or higher average dose or changes in gross net or any other factors.
Hit a return your <unk> for the for that answer so just to clarify. The question is the forward looking through the end of this year <unk> is driven by a new patient and more tablets out the door to those measures.
And enter your question about dose <unk> rarely changes it's been the same same average Joes for Mister Smith.
Okay, I'm, sorry, if I missed this I I got on late but did you comment on the competitive environment are you seeing any embarrassed from <unk> from the more mature products I'm curious if you had a company's maybe you're seeing that accompanies do anything differently than they have in the past maybe at the end of that.
Mmm no no grade you didn't miss it but we understand the question and Sean will answer yeah, very similar to what however spot in the past on this one we we haven't seen another back.
Honestly the more companies are out there talking about our proposal reasons awareness I just mentioned is lacking in certain areas and ultimately it auspicious.
Okay and then.
Hi, Grace hesitation enrollment been hitting your targets.
Yeah.
Oh, we don't typically talk about enrollment, but we talk about is our focus on to make it a N D. A and the team is focused on completing that N D. Eight in the second half of next year and I'm very confident team is working hard to meet that target of submitting that N D. A and we've taken as I think I've sat on previous calls and all hands on deck approach and that continues where where cross functionally.
Working with investigators as well as working internally not only to involve the study, but awesome to start actively in writing and completing the NDA today and we are actively working on the NDA getting rapidly working with the F. D. A.
We've completed.
Investigating meetings U as in Europe , Uhm this year and we made many one on one visits to our key investigators and it's clear after meeting with those investigators and talking about the trial that they have an unwavering support and excitement around relic Cortlandt and Grace study and are committed to completing this trial.
He said when you expect to enroll the last patient.
We expect to submit an N D a by the.
Second half of 2023, that's our focus.
Yeah understood. Okay. Thanks for taking the questions.
Thank you.
One moment for our next question.
Which comes from the line of Alan <unk> Biological your line is now open.
Alright, this is Alan <unk>.
Alright.
Yeah I have.
<unk>.
You're fine Great question, what let me ask her how prevalent is nash or fatty liver a month.
<unk> <unk> <unk> <unk> <unk> <unk> and the current.
Quatre can lose weight gain trial.
Yeah you're.
Your question was a little hard to hear I'm Gonna repeat it and then I'll answer the question I thought I heard we'll go from there I I think you were asking is what is it known or do we know the prevalence Nash in patients who have who.
Who had chronic psychiatric illnesses and are treated with anti psychotic medications. If that's that question again, we don't know the prevalence I don't think anybody knows the prevalence I don't think it's been account did it that way, but it's not zebra.
<unk> without a doubt these are patients who have overweight and they have often medications have had it been overweight for a real period of time and those certainly those two characteristics are certainly Carrie.
Correlated with the development of fatty liver disease and Nash. So I can't answer your your question quantitatively or qualitatively, it's certainly something which exists.
Yeah, the same questions for <unk>.
What do you know about.
Metabolic syndrome.
Especially when I look at the literature.
N F M, you're all muscular facing the theater experience.
<unk>. This regulations so does it get your commentary on that.
Well you know it's good that thank you for giving me the opportunity to talk about that uhm, it's really been known for quite a while probably 20 years that patients with a L. S have hydrocortisone exhibit hyper cortisol.
Never really been knowing what to do about that if that wasn't that leading to their disease, but but you know it's sort of the key element for us was a very strong academic.
Academic researcher to treated an animal model that Bob.
It was <unk> state of animal model for a L. S and found the treating them with a cortisol modulator really led to Paul pathological clinical improvements now how they relate to you know I'm not sure. If the question was about whether those patients have metabolic services I know that lash and some says issue.
<unk> so profound that you don't see a lot of reporting of other symptoms. So I've I've never actually heard that question posed before and I'm not sure I've ever seen any literature on it.
Last question do you have the MRI Nash Substudy would it.
Also be it was a tech byproduct composition structure because in the past.
M R. I detected only cost changes, but I wanted to make sure I haven't missed anything.
Very recent improvements in there my eyes.
Yeah for that question I'm Gonna give you back to Bill <unk> really.
Is a uhm Nash expert in.
He didn't feel for many years go ahead, yeah. Thank you for that question. So for the sub study I mean, our focus mainly is around that never fat reduction and the reason for that is it's been seen in most literature that when you get at least a 30 per cent dropping the bat reduction that corresponds to getting improvement in <unk>.
Then the face won't be studied we're not looking at fibrosis at this time, but there are other noninvasive markers that I'm gonna be using in analyzing have those biomarkers to look at improvements in liver fibrosis taken who will then take those learnings and apply them as we move forward to a phase two study and use those same parameters Android.
Liver biopsies as well, but yes, we will be gathering biomarkers to look at my router is to see if we're seeing improvements there as well.
Thank you looking forward to the next month.
Yeah. Thanks. Thanks, Thank you Allen and thank you to everybody who listened in look you're really looking forward to our next communication and hope you have a good rest of the week. Thank you very much.
Okay. Thank you for your participation in today's conference. This does conclude the program and you may now disconnect.
The conference will begin shortly to raise your hand doing <unk> you can dial star one one.
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