Q1 2023 Corcept Therapeutics Incorporated Earnings Call
Good day and thank you for standing by welcome to that of course up Therapeutics Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you'll need a press star one one on your telephone.
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<unk> <unk> <unk>.
Mccorry. Please go ahead.
Hello, everyone and thank you for joining us I'm out of <unk> of course, I've Chief Financial Officer.
Today, we issued a press release announcing our financial results for the first quarter and providing a corporate uptake.
Copies available of course up dot com or.
A complete financial results will be available when we file a Form 10-Q F C C.
Today's call is being recorded.
It will be available at the investors past events tab of our website.
Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations that are subject to risks and uncertainties with 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, and the risks and uncertainty that may affect them are described in the press release and in our annual report on Form 10-K, and our quarterly reports on Form 10-Q.
Please refer to those documents for additional information.
We disclaim any intention our duty to update forward looking statements.
Our revenue in the first quarter of 2023 was $105.7 million, an increase of approximately 13% compared to the first quarter of last year.
With about half of that growth being due to an increase in the number of patients receiving carlin.
To reflect that grows.
We are raising our 20th twenty-three revenue guidance to arrange a $435 million to $455 million up from $430 million to $450 million.
Net income was $15.9 million or 14 cents per share in the first quarter compared to $22.8 million or 20 cents per share in the same period last year.
Due primarily to higher operating expenses as our development programs advanced and we increased investment in our Cushing syndrome business.
Or cash in investments.
31st with $465 million compared to $437 million Ah December 31.
In April we purchased 6.6 million shares of course have common stock for $145 million.
I will now turn the call over to Charlie Rob, Our Chief business officer to provide illegal empty Charlie.
Thanks and back.
In March 2018, we do cover in Federal District Court to prevent it from marketing a generic version of Cortland in violation of our patents.
Last quarter, the court orders the parties to negotiate a schedule for pre trial activities.
<unk> now set to begin September 27th of this year keep.
Keep in mind that Java can no longer challenge the validity of one of the patents we are serving against it that you want for Patton, which was reaffirmed by the patent trial and Appeals board following or preceding initiated by Tyva known as post Grant review.
Having lost at the patent office turban must concede the 214 patents validity at trial Tevis only remaining defenses that is proposed product, we're not infringe or pattern <unk>.
Physician, we believe has no legal or factual support keep in mind also that the 214 pattern is just one of four that we have asserted against Deborah.
Having a restarted these facts it is customary to say we are confident in the strength of our legal position that is certainly true. So I would say we are confident in the strength of our legal position.
The problem is that this sort of stock phrase does not capture the depth of our conviction. So.
So let me put it another way my colleagues and I are glad a trial date has been set we look forward to our day in court, we have never sought to delay or prolong this litigation because of the law and the facts are on our side. We are absolutely confident we will win.
I will now turn the call over to Doctor Joseph Belanoff, Our Chief Executive Officer. So.
Thank you Charlie.
Are Christians syndrome business is built on a solid foundation of life saving medication promoted by a commercial teams that puts the interests of patients first.
Giving endocrinologist increasingly believe that there are considerably more patients with Cushing syndrome. There was once assumed.
Laurel them as an excellent treatment for patients with Cushing syndrome, and there are many eligible patients who have yet to receive it we are making substantial investments to improve the screening and treatment of these patients most notably a recently initiated catalysts study and are extremely optimistic about the growth potential of our Cushing syndrome business and.
In the first quarter, we saw an increase in the number of patients receiving Carla and then the number of physicians prescribing. The medication, we are raising our 2023 revenue guidance range $135 million to $455 million.
We are also very encouraged by the progress of our clinical development programs since inception, our research and development efforts have built on the hypothesis that cortisone modulation can be a powerful therapeutic mechanism in many serious disorders.
Our proprietary compounds modulate cortisol setbacks, but a binding through the Coca Cola to glide receptor G. R. The receptor, which is activated when cortisol levels are high.
Do not find you the progesterone receptor incident caused some of <unk> are approved products most serious off target effects.
Interestingly, while our compounds modulate cortisol activity without modulating progesterones activity, they're not identical some cross the blood brain barrier others do not some perform best in models of solid tumors, others or more potent metabolic disease, some appear to be tissue specific others have more globe.
Little effects.
These diverse qualities allow us to study a wide variety of disorders. Currently we are conducting programs with three other proprietary selected cortisol modulators railroad correlate desert correlate in Miracle, Maryland.
Darien adrenal in prostate cancer L. 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 our Grace gradient and Nash Phase one of these studies submission of the N D. A for relic correlate in Cushing syndrome completion of enrollment of our catalyst Rosella and dazzle studies and initiation of a phase two be trial of Miracle, Ireland in patients with Nash.
This is very exciting time for core set.
We are evaluating relic laurel and in the treatment of hyper <unk> into phase three trials Grace and gradient railroad.
<unk>, it's a selective cortisol modulator light cortland it achieves its effect by competing with cortisol at the glucocorticoid receptor.
Unlike coral him he does not bind to the progesterone receptor P. R for short and so does not cause P. R related side effects, including termination of pregnancy, endometrial thickening and vaginal bleeding by a different mechanism relic correlate also does not cause hypokalemia low potassium serious side effects experienced by.
44% of patients and Portland's pivotal trial.
Korlym induced hypokalemia is a leading cause we're just gonna be duration.
<unk> Orleans phase two efficacy and safety data were compelling patients experienced meaningful improvements in hypertension, and glucose control as well as in a variety of other signs and symptoms of Cushing syndrome.
There were no rella, Florida induced instances of endometrial thickening vaginal bleeding and no drug induced hypokalemia. The trial results were published in front tears in endocrinology in July 2021.
We are pleased to share that we have identified all the patience necessary to complete our grease trial.
We plan to complete enrollment in the coming weeks grateful serve as the basis for NDA submission in Cushing syndrome, which we plan to submit in the first half of 2024.
Our second phase three trial and hydro <unk> gradient studying rella correlates effects in patients, whose Cushing syndrome is caused by an adrenal adenomas or adrenal hyperplasia.
Patients with this ideology Cushing syndrome, often experience a less rapid decline, but their health outcomes are poor, including a higher risk of death.
Well, we do not expect our NDA in Cushing syndrome to depend on data from gradient. We do expect that its findings will improve the care of these patients.
We're also excited that are recently initiated catalysts study just now enrolling patients.
List is a thousand patient phase for trial examining the prevalence of hyper core resolve isn't in patients with difficult to control type two diabetes.
Patients diagnosed with hyper cortisol lesson may enter a randomized double blind placebo controlled study of <unk>.
Many independent studies conducted over the last 15 years I've found that the prevalence of hyper cortisol isn't in patients with type two diabetes is substantially higher than in the general population if.
The most prominent diabetologist in the United States helped us design and are participating in catalyst, which will be the largest study of its kind data from catalyst will enable physicians get better identify identify and care for these patients we expect to complete enrollment by the end of this year.
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 the program cell death that chemotherapy is meant to induce in solid tumors.
Of course, all works against the beneficial effects of chemotherapy by suppressing a pop doses.
And are successful control phase two trial and women with platinum resistant ovarian cancer. The addition of are selected cortisol modulator relic cortland enhance the effect of chemotherapy likely by planting cortisol anti apoptotic effect.
Relic or a link provided meaningful benefit to many of the women in our study while these women's disease had progressed on two or more previous lines of treatment, including previous taxis railcar relic or what appeared to re sensitize the disease to chemotherapy is beneficial effects and some women.
Those who received relic or on intermittently the day before the day of and the day. After they received <unk> exhibited statistically significant improvement progression free survival and duration of response compared to the group who received nap paclitaxel mono therapy <unk>.
We weren't in the intermittent <unk> group also live longer than those in the comparator arm with a P value that approached statistical significance.
29% of the patients who took intermittent <unk>. We're alive two years after their study start versus only 14% who took nab paclitaxel alone.
Perhaps even more important the women who received <unk> plus now paclitaxel experienced no additional side effects burden compared to those who received now paclitaxel alone.
The results from the study of been submitted for peer review publication and were featured in podium presentations at the 2021 and 20 twenty-two European Society for medical oncology is Mel meetings, and the 2022 American Society of clinical oncology ESCO annual meeting.
Rosella are pivotal phase three trial and recurrent platinum resistant ovarian cancer is enrolling patients rosella design closely tracks. Our phase two study planned enrollment is 360 women randomize, one to one to receiving the relic or one plus nap paclitaxel or nap paclitaxel alone the <unk>.
Primary end point is progression free survival with overall survival of key secondary endpoint. We are conducting a study in collaboration with leading 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 in rosella by the.
End of this year.
Our goal in phase three is simply to replicate are positive phase two results, leading gynecological oncologists have told us that in their view road corals potential benefit improved progression free an overall survival without increased side effect burden, we constitute an important medical advance and the railroad.
Aurulent plus nap Paclitaxel has the potential to become a new standard of care and women with platinum resistant ovarian cancer.
A second mechanism by which cortisol modulation may prove useful as my 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 and salute them I'd eventually experienced research and disease <unk>.
Deprived of Angela androgen stimulation their tumor switch to cortisol activity to stimulate growth.
R. I potthast is is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route by.
By mid year of collaborators at the University of Chicago plan to begin a randomized placebo controlled phase two trial umbrella coralline, plus and Hulu to mind in patients with prostate cancer before these patients have had an initial prostatectomy.
A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapies intended to stimulate the immune system.
[noise] hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance the effectiveness of those therapies. We are conducting a phase one be trial umbrella correlate plus the P. D. One checkpoint inhibitor pepper iliza map in patients with advanced adrenal cancer, which tumors produce excess <unk>.
<unk> <unk>.
<unk> is rarely effective as mono therapy and 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.
<unk> are 198 patient randomized double blind placebo controlled phase two trials desert correlate in patients with Alice as briskly enrolling patients.
Correlate as a select a cortisol modulator that has shown great promised in animal models of a L S improving motor performance and reducing neural inflammation and must muscular atrophy.
We're conducting this important study in collaboration with try cows, the leading a L. S. Academic consortium in Europe , we are attract 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 Miracle Aurulent, an oral medication continues to demonstrate great promises of treatment for Nash and our prior Nash study patients who received mirror cortland exhibited large rapid reductions.
In liver fat.
But also substantial I'll be a transient elevations of the liver enzymes L. T N E S T.
The improvement in liver fat in these patients was greater than occurred much more rapidly than we had expected and is rarely seen over any period of treatment.
Our phase one be dose finding study, which is completed enrollment has identified a range of doses all substantially lower than originally tested doses that appear to cause large reductions in liver fat without causing excessive liver irritation, we expect to share results from the study by mid year and plan to start a phase two trial.
And the fourth quarter of this year.
In conclusion, we are extremely optimistic about the growth potential of our Cushing syndrome business, which continues to generate substantial profits even as our development programs advance we have raised our revenue expectations for this year and expect growth for years to come.
Our newest study catalyst represents a significant investment to improve the screening and treatment of patients who is difficult to control diabetes is caused by hyper <unk>, a population, whose cushing syndrome too frequently goes on diagnosed.
Our development programs are generating increasing evidence that validates our long held belief that cortisol modulation has the potential to treat a wide range of diseases, reducing cortisol activity is a straightforward and effective way to treat Cushing syndrome, and can offer substantial benefits to patients with other serious disorders.
Ovarian cancer L. S and Nash are current examples, but there will be others.
In addition to <unk> and Miracle Island, we have many other proprietary selective cortisol modulators in our portfolio and potentially very different clinical attributes.
In the next 12 months, we will see data from our development programs in Cushing syndrome, and liver disease will submit Ralph Aurulent NDA in Cushing syndrome, and will complete enrollment in large controlled studies of recurrent platinum resistant ovarian cancer <unk>.
S and diabetes caused by hyper cortisol Ism, we will also begin a phase two be trial in patients with Nash.
As I said it is an exciting time for <unk> I think are dedicated creative employees and loyal investors for making that possible.
I'll stop here for questions.
Thank you.
I need to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again, one moment, while we compile the Q&A roster.
Our first question comes in a line of Matt Caplan with Ladenburg. Your line is open. Please go ahead.
Hi, congrats on that results with a quarter can.
Can you give us.
A little bit more insight into into into the great study and and how enrollment has has evolved here and what your thoughts are you said in the coming weeks you expect it to complete can you give us a little bit more detail. What you are the best.
Sure a matinee and good to speak with you, let me reintroduce everyone to build guy or Who's our Chief development Officer and runs all of our clinical programs spill great. Thanks for that question I mean first and foremost we're excited and focused on finishing the great study as our each and every one of our investigators around the world because they see the benefit the roller correlate can bring.
[noise] to their patients not only from the phase two trial, but from what they're saying currently in the phase three trial.
In the past few months, we've seen unprecedented a number of patients coming into the clinic and being screened for this trial more than we've ever seen previously and therefore based on that all of the patients to complete the study have been identified and we're working them through the process to enter them into the study and we plan to complete enrollment in the coming weeks and what you need.
To understand is for this trial for the Grace trial, you know Cushing syndrome is a very complicated disease require multiple criteria to confirm that they qualify for this particular study and the screening process takes on average or about six weeks and sometimes that can be longer but we believe we do have all the patience needed to enroll this trial.
And that's that's very helpful. Thank you and then just just staying here.
The catalyst studying you're you're studying and a thousand patients.
Can you give us a sense of what you believe currently the prevalence is hypocotyl, it's always on in in in this type two diabetes diabetes patient population.
That could've been good questions from Yeah, Yeah, right right right question I mean, when you look at multiple.
Independent European studies to be specific because that's where most of the research has been done that have been conducted over the last two decades, you know they found that the private prevalence of hyper cortisol ism in patients with type two diabetes is substantially higher and arranges an estimate between 17 and 33% with patients that fit this type of profile that we're looking at in the catalog.
Study and therefore, it's clear to us that there are more patience with Hypercriticism. However, there are no U S or American studies like this and this will be the first U S study and it will be the largest prospective study ever done.
Okay, alright, well thank you.
<unk> just in case for the honest I just Wanna remind you of one thing it's not 70 to 33 per cent of those patients with diabetes. It's 17 to 33 per cent of patients who have difficult differently or factory diabetes, who can try on many different medications. So I understand it's a it's a large number of of a substantial subset but.
Not the type of patients with diabetes.
Okay.
No.
Alright, Uhm I'll hop back into the queue now okay.
Thank you and one moment for our next question.
And our next question comes from the line at David and Slim with Piper standing by your line is open. Please go ahead.
Hey, Thanks, So just add a couple first can you talk through margin expansion.
Over the long term I'm, particularly interested in how we should think about the benefit of the salesforce expansion and how we should ultimately think about operating margin expansion over over time and I guess, there's a court.
Just philosophically you've given all the pipeline activity.
Okay.
R&D span uhm longer term and and I guess more specifically should we think of that sort of at a steady today figure percentage of sales Burger how do you think about that.
Not there.
Oh, Okay. Thank you, David and I would try to sort that out as as as best we can so first again for the group. Let me reintroduce you too Sean the Duke was the president of our Endocrinology Division and Sean several of those questions really fall under your domain. So please go ahead, yeah, David Thanks for the question I'm, So I'll touch on.
Salesforce specific question of growth.
I'm going to take everybody back to the beginning when we launched Carla we started with a very small salesforce then as we.
The rest of the time, we've added to go on that team, so where where are we now we're really focused on continuing to develop and strengthen the payment we have and add to it in and we will complete our expansion to 60 clinical specialist in the coming months.
Our our newest clinical specialist that have joined last year are starting to contribute we expect that contribution to to continue to increase on the second half of this year and you know the rationale of why why are we continuing to expand it's it's the understanding and recognition of hypercard as always and continues to evolve and grow on the market.
More and more physicians are being educated and and are aware and and right. Now are the best ways for us to get in front of them is obviously with our field support so right now we're planning to get the 60 in the coming months and we will continue to assess that team over time and determined.
Yeah, and and David <unk>, Let me address the other question you asked about research and development spending our philosophy has always been we're gonna support successful results to move drugs through the development pathway to approval.
There's always some ebb and flow I mean, Wednesdays are in earlier stages. They are less expensive to run as they get to phase three they become more extensive to run, but we really think that we have the ability and will support anywhere where the data indicates that a drugs useful to patients and substantial way and we can.
Get approval and so you know I I think they are spending on research and development will be substantial over a long period of time, but only you know.
Simpsons to the benefit of making the business more profitable and serving more patients. So I'll I'll give you like a an example, which we haven't talked about today, we're doing the study in platinum resistant ovarian cancer, we feel the raw obviously all funded for that that's to the end and we feel very confident about that how.
However, we believe that that study is successful there are obvious places where real coral and it can also be used then oncology and we will fund those studies as well so even as in the future you know fingers crossed we are earning money from plattner resistant ovarian cancer business, we will be supporting other studies been in la.
Charger footprint in oncology so.
I guess the simplest way that I can answer that question is that our spending in research and development is not likely to decline is likely to increase as our business increases in our drugs are successful.
Okay. That's helpful. If I may need to sneak in a follow up visit.
Beyond this initial this this expansion.
That you're going to be right size in terms of the commercial infrastructure do you envision additional commercial infrastructure expansion overtime.
Yeah, I'm going to throw you back to Sean for that Yeah. No. Thanks for the question at this moment in time, we believe that will be right sized with that infrastructure, but as I said on your previous question. It's something that we look at very closely and if we feel like there's an opportunity to to how to grow that team, we will assess at that time and do something.
Thank you.
Thank you David.
And one moment for our next question.
And our next question is gonna come from the line at Edward Nash with Canaccord. Your line is open. Please go ahead.
Hi, Thanks for taking my question I wanted to ask about the a less trial. It's your your conduct at trial was trike house in Europe , and just wanted to understand kind of what the the next step would be specifically as as it relates to the U S.
Yeah, Great question, Yeah. We've designed this trial as a phase two trial to be majority run in the European Nations and the reason for that is we've got 25 sites in Europe that are going to be active in enrolling in enrolling extremely well ma'am I think Joe It stated that earlier that day.
Very brisk when we look at the United States, We're actively working with the F. D. A to get R. M. I N D open to allow us to initiate the study here in the United States.
Yeah, we only planned to have five citing that each state for this trial.
Got it and then just switching over to Nash your submit your gonna look to get into a phase two be trial. So I assume this you're going to go straight into a this'll be a biopsy driven trial.
<unk>, Yeah that is correct I mean, we believe in our phase one B study that we've accomplished dark all to find dowson dosing ranges that allow us to reduce liver fat overtime at a steady pace without seeing any uhm rises in a L. T and that allows us to then feel confident to go forward into.
Phase two be trial, which will be a biopsy driven trial correct.
Great. Thank you very much.
Thank you.
Thank you and one moment for our next question.
Our next question comes from the line at least with S. D. B Securities. Your line is open. Please go ahead.
Great. Thanks for taking the question. So I'll start with one on coralline I was curious what recent trends are you seeing among prescribed Where's that gives you confidence in your new guidance for 2023, and along those lines any new strategies in your field forces using to help educate and drive more prescribing there too.
Yeah, I hadn't realized nice to meet you thanks for being on the call I'm Gonna pass you again back over to shock.
First question I think in terms of trends. There's just an increased understanding of our proposal is I'm in a realisation for these physicians that these patients may.
[noise] exist in their practice, so there's more screening going through more screening more patients are being found and that's something that we've seen sort of universally across the country, which is drove through the Q1 results. We have more patience on coral them than we've ever had as a company and obviously factored in to the new guidance range.
So in terms of the second part of the question is tactics for the field I think I'll I must speak about a couple of big initiatives that we're working on organizationally, one relates to the field and whatnot, but they are both very important both for today and I think for the future of the business I already mentioned on touched.
Touched on the growth of the Salesforce again, that's on track and we're really spending a lotta time working to strengthen our team and we are definitely seeing results from that effort. We know that these patients are out there and I finished all physicians have not been educated yet recognize that that through that education their awareness of the potential.
With locations and their practices inquiry. So we think that that this increase in disease awareness or streamline training efforts, we'll make our clinical specialist more productive in in for a new newest clinical specialist obviously more productive more rapidly. So we're seeing benefit on that side effects. The other is just catalyst I wanted to touch on on again, Joe mentioned it in your.
Putting notes and Bill just spoke to it and again that's the face for study that we initiated in Q1, but you have to understand that a great deal of the data in this patient population already exists bill touched on it but many smaller retrospective studies have shown that patients with difficult to manage diabetes or a different disproportionally higher prevalence of underlying.
Course, I prepared is all of them and as we said catalyst is the largest prospective study ever done it.
This group of patients and I believe that this is that it will be the definitive study for this patient population, it's gonna provide physicians with the prevalence in treatment data needed to encourage increase screening obviously that will lead to diagnosis and then treatment.
Go over the last few months I have actually been in the field talking to physicians and this is one of the things that we've talked about it and I can tell you that they are very interested in this study and its findings disease awareness is evolving.
Ross The board and the time is right for this study and all the other initiatives that we have underway and ultimately all these initiatives are going to improve patient care, which we're very excited.
And really the bottom line from all of this is that we are confident.
What our outlook for the remainder of the year and.
Really look forward to seeing.
The growth of challenges talking about over an extended period of time.
Yeah. It makes sense Super helpful and one more from me I was curious if you could remind us what is the bar for efficacy that you're looking for both in the Grace ingredient trials and any other details that you hope to tease out from the date of results.
Yeah, Let me give you back to bill.
So for the Grace try let me remind you would say a randomized study, but yet there's the initial part to that study. There's an open label piece to it where we're evaluating patients who were on Ralph correlate in for those who meet the criteria of response for hypertension and diabetes, then get into the randomized withdrawal piece of that trial and we're we're looking at.
Results there is that loss of control as we randomize them to either stay on <unk> or be randomized placebo. So that's the end point. We're looking for is the portion of patients who lose control versus that who maintain control and that's for Grace and then for the gradient trial.
At the outset, it as a randomized placebo controlled trial and so in those patients with high for quarters at least some we're looking at the comparison umbrella cortlandt versus that of placebo and similar but yet slightly different we're looking at the response to the hyper glycemia and points as well as the hypertension and points and so we're looking for statistical significant <unk>.
Changes there in either one and hopefully both of those endpoint.
Oh.
Got it great. Thank you.
You're welcome.
Thank you and one moment for our next question.
Our next question comes from the lineup, Greg Frasier, which released your line is open. Please go ahead.
Thank you and good afternoon books.
I'm, calling sales growth.
Quite a bit with a quarter I know they start for Ya seen some pressure on that failed in the first quarter due to insurance research, but let me see what other drugs. He bucked that trend this quarter, what went better than expected any color on that would be helpful.
Yeah. Thanks. So the you know every year in the first quarter as you just mentioned, we expect a decline in pay tablets due to the impact of the donut hole in insurance Reauthorizations sure. However that seasonal impact was muted somewhat by the increase in our patient based on our growing business.
What what volume growth in the order.
Okay, you're you're over here with around six per cent volume right.
Thank you and then on SG&A.
Spend with us.
Significantly quarter over quarter, you've mentioned spending more behind the cushions business over there.
Any one time items in the quarter, how should we think about SG&A spend over the next couple of quarters.
Yeah.
No not not really any meaningful one time expenses I mean, I think the only a small portion is related to expenses related to the tender offer which was sort of in the million dollar range, but I I'd say, if you look through the rest of the year operating expenses.
Well approximate what we saw in the first quarter.
Got it okay.
And then on the pet in case you engage in settlement discussions with Heather are are you still open to exploring settlement you clearly confident in your position, but I'm wondering if a settlement that would bring certainty and also reduce the legal spend is still a possibility. Thank you.
I just wanted to remind everyone has a charlie robbed who's going to answer this question.
Well, yeah settlements always possible in every in every case and you know where a rational businesspeople. So in that sense, yes settlements possible, but I I really think our focus and everyone's focus and expectation really should be on on our going to court and beating Tyva. That's our plan and I think that is it.
But you know that that is the the expectation we're working towards.
Thank you.
Mmm.
Thank you and one moment for our next question.
Our next question comes from the line of Alright, then he was H C. Wainwright. Your line is open. Please go ahead.
Hey, good afternoon, everyone. The the author <unk>. Thanks for taking my question and congrats on the first quarter it progressed.
Most of my question is being asked I had a two quick while on the <unk> study one is for the ovarian cancer study could you remind us for the inclusion exclusion criteria Oh is there any specific cut out for the <unk>.
I ended up pumping inhibitor usage for the patient.
Yeah, Let me give you back to Bill Guy. So thank you for that question. So yeah, we're looking at inclusion exclusion criteria.
Women with platinum resistant ovarian cancer, who were previously taken one to three lines of therapy with one of those lines being prior bevacizumab.
There is no restriction to park inhibitor requirements in this trial.
So that hopefully answers your question.
Yeah. It is it is thank thanks for that and so regarding the Nash study email for the phase two study upcoming.
Training because I noticed you mentioned the multiple dosing regimen it could be could working in the are you planning to take multiple does tomorrow and regimen into the study.
Oh that is our intention.
We will be working with the top Nash specialist in Herpetologist through this process to help advise us on how to best move forward into phase two b, but yes, our intention is to take multiple doses compared to placebo interface to be trial.
Arthur just uhm, let me add add to the.
When you're starting at the beginning of first trials and you and in some sense. You know you don't know exactly what you are again as he noticed things from animals don't always translate exactly.
As it turned out a mere coralline, although it was.
Very potent and animals than we expected some drop off into humans was equally or more potent in humans and as a consequence, the dosage that bill's been testing and his face wouldn't be study really are substantially lower doses that we thought initially we're going to be required and frankly, there's more than one other than it looks promising.
So we're really in the process of designing that face to be study right. It.
<unk> study right now we know we're going forward, but exactly what it's going to <unk>.
Encompass in terms of dose groups is being determined and you'll know that in the next three months or so.
Awesome. Thank you. Thank you for taking my question and congrats.
Okay.
Thank you very much thanks for everybody for listening in hope everyone has a good next three months and we look forward to catching you up at that point in time.
Good afternoon.
This concludes today's conference call. Thank you for participating you may now disconnect.
Mmm.
[music], Okay [music].
Mhm.