Q2 2025 Corcept Therapeutics Inc Earnings Call
Okay.
Thank you for standing by and welcome to core Sept Therapeutics second quarter 'twenty twenty-five earnings conference call. At this time, all participants are in a listen only mode.
After the speaker presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone to remove yourself from the queue. You May press Star one one again.
I would now like to hand, the call over to out about Macquarie CFO. Please go ahead.
Yeah.
Thank you Hello, everyone. Good afternoon, and thank you for joining US today, we issued a press release announcing our financial results for the second quarter and providing a corporate update copies available of course that dot com, our complete financial results will be available when we file our Form 10-Q with the SEC.
Today's call is being recorded a replay will be available at the investors past it at <unk> website.
Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations that are subject to risks and uncertainties, which may cause actual results to be materially different from those such statements expressed or implied.
The risks and uncertainties that may affect our forward looking statements are described in our annual report on Form 10-K, and our quarterly reports on Form 10-Q, all of which are available at the Sec's website.
If you refer to those documents for additional information.
We disclaim any intention or duty to update forward looking statements.
Our revenue in the second quarter of 2020.
Right.
$163 $8 million in the prior year period.
We have modified our 2025 revenue guidance to $850 million to $900 million.
Net income was $35 1 million compared to $35 $5 million in the second quarter of last year.
Our cash and investments at June 30 were $515 million balance reflects our acquisition of $115 million of our common stock in the second quarter pursuant to our stock repurchase program and that exercise of stock options by of course, our employees and the last vesting of restricted stock grants.
Now I'll turn the call over to Sean <unk> President of our Endocrinology Division, Sean. Thank you what about the.
Allergy Division had an excellent second quarter for the sixth quarter in a row, we added a record number of new prescribers and new prescriptions and there are a record number of patients on therapy, we shipped more tablets to patients than ever before 49% more than the second quarter last year.
Our financial results don't fully reflect the surge in demand.
Quarterly revenue growth, a substantial a $37 million increase over the first quarter.
Should have been more I discussed on the last call the insufficient capacity of our pharmacy van <unk>.
This capacity has increased in the second quarter, but not as much as we expected and not enough to keep pace with our growth capacity will increase further in the second half of the year. We dispense another record number of tablets in July with more increases to follow.
We're also bringing online a second pharmacy, you will see the financial impact of this edition in the fourth quarter.
Increased pharmacy capacity is important because I'm certain our growth is poised to accelerate.
For many years physicians only screen contributed the most physically obvious cases of hyper cortisol.
In the last 15 years. Many studies have been published supporting the identification and treatment across a much broader spectrum of diseases.
There is also the catalyst study confirm and built on these findings and will lead to much higher rates of screening and treatment of hyper cortisol.
The study unequivocally shows that one in four patients with difficult to control diabetes, a hyper cortisol.
Treatment with a cortisol modulator dramatically improves many of their signs and symptoms, even when all current medications, including <unk> and <unk> have not.
Catalysts results are now published in diabetes care the fields, leading journal.
This crucial information is now being absorbed by the broader physician community. We have amplified our efforts to educate physicians about hyper cortisol or something and we will ramp those activities. Even further for example, we've increased the size of our sales force substantially and will continue to grow that team.
We currently have 145 clinical specialists up from 60 at the beginning of 2024 and our plan is to have 175 in place before year end.
And the increase in context of a much better understanding of the prevalence of hyper cortisol I'm eagerly anticipating <unk> approval.
Korlym is a great medication Rolla Portland is even better.
It'll be a terrific option for both prescribers and patients I expect that almost all patients who are receiving korlym will choose to transition to rolla, korlym and our growth will accelerate when it becomes available.
I've never been more confident in both our current and future commercial growth and most important our potential to help many more patients I believe that in the next three to five years roller korlym will generate $3 billion to $5 billion in annual revenue.
Cortisol is them alone.
I'll now turn the call over to Charlie Robb, our Chief business Officer, Charlie Thanks, Sean.
And last there is something to report regarding our patent litigation with Teva recall that in 2018, we sued Teva to keep it from marketing a generic version of Korlym in violation of our patents traffic place in September 2023, and December 2023, The district Court ruled against US we appeal that decision to the federal circuit.
Court of Appeals and completed briefing in May 2020 for a few weeks ago on July seven the court heard oral arguments in the case the last step before issuing an opinion.
The three judge panel was led by Chief Judge Kimberly more in 2021 judge more was a member of the panel that rejected tevis challenge to the validity of one of the patents, we asserted at trial and royalty opinion in our favour.
I don't mean to suggest the judge Morris favorable decision in 2021 mean, she is more likely to rule for US now the issues now are different.
<unk> decision in 2021 concern the validity of our patents she found valid.
<unk> argument concerns infringement will cover infringe our patents and entirely different question.
My point is simply that judge more is not new to this dispute she understands our particular situation not just the war and the abstract for a party that believes as we do with the law and the facts are on its side <unk> patent expertise and depth of knowledge is a good thing.
It is impossible to say when the federal circuit will issue its decision sometime in the next two to three months would be a reasonable guess if we prevail in this case turbine will lose FDA approval of its product until the expiration of our patents and 2037.
As I've said before we are eager to resolve this appeal we strongly believe our position is correct and that the federal circuit will agree.
I will now turn the call over to Dr. Joe Belanoff, Our Chief Executive Officer, Joe.
Thank you Charlie and thank you everyone for joining us this afternoon.
After many important years building. This point next year at <unk> is about to arrive as.
As we have always known cortisol enters all organs in Dubai and modulating its effects has the potential to be useful in many diseases. We now have two new drug applications NDA is in progress and hyper cortisol.
Platinum resistant ovarian cancer the.
The results of the studies, leading to this NDA is were published in major medical journals in the second quarter. We have also generated promising results in our AOS in liver disease programs ensure we have established a new medical platform, we sold many patients suffering from serious disorders.
The results of our catalyst trial, the largest and most rigorous trial ever conducted to assess the prevalence of treatment of hyper cortisol lithium in patients with difficult to control type two diabetes will transform medicine.
The prevalent space of catalysts demonstrated that one in four of these refractory patients is high for cortisol lesser.
Far higher rate than was previously assumed.
In April these results were published in diabetes care, a leading peer review journal of the American Diabetes Association.
Patients who enrolled in the treatment phase of catalyst had uncontrolled diabetes, despite receiving multiple glucose lowering therapies, including the most potent <unk> one agonists.
Even so in only 24 weeks patients treated with Korlym experienced a 1.47% reduction in hemoglobin <unk> C compared to just 0.15% for those receiving placebo.
The P value of this result was less than a point zero zero.
In addition, patient saw significant improvements in a range of additional endpoints, including reductions in body weight and waist circumference, notably patients in catalyst experienced these improvements even as they decrease were entirely discontinued their other glucose lowering medications.
The results were presented last month during the keynote session at the American Diabetes Association is 80 bps scientific sessions with a simultaneous publication in diabetes care.
Catalysts findings were substantially accelerate the screening and treatment of hyper cortisol, Elisa, leading diabetologist or advocating for their quick integration into treatment guidelines.
Concurrent with the rapidly increasing physician awareness of hyper cortisol Ism ROE Korlym is approaching approval. It's paducah date in hydro cortisol as December 30.
Rella correlates NDA is supported by our pivotal phase III Grace trial as well as our gradient long term extension and phase III trials in these studies patients treated with <unk> experienced clinically meaningful improvements across all of the signs and symptoms of hyper cortisol lesser including hypertension hyperglycemia.
EMEA weight lean muscle mass Waster conference cognition Cushing is quality of life score and other important clinical measures. These benefits were observed consistently and durably with improvements emerging early and continuing or deepening over time.
Equally noteworthy <unk> safety characteristics Gorilla corridor has been well tolerated in all of its studies importantly, no instances of drug induced hypokalemia endometrial hypertrophy vaginal bleeding adrenal insufficiency or Qt prolongation have been observed.
These adverse events can have serious health consequences, and our associated or one or more of the currently available therapies.
We expect that <unk> efficacy and safety will make it a new standard of care for hyper cortisol with them as.
As awareness of the disease and its ability to be treated grows many more patients with hydro <unk> will be identified and of course that is well positioned to help them.
As Sean said earlier, we are confident that our Cushings syndrome business, we will continue to grow for years.
Since the founding of course at our research and development has been built on the ipod hypothesis that cortisol modulation can be a powerful therapeutic mechanism in many serious disorders.
Success of our pivotal rosella trial in platinum resistant ovarian cancer provides clear evidence that cortisol receptor antagonism has substantial potential in oncology.
In Brazil up 381 women with platinum resistant ovarian cancer were randomized one to one to receive either Nab paclitaxel. The most potent chemotherapy currently available for these patients where Nab paclitaxel plus rattler correlate.
In these patients the efficacy of Nab Paclitaxel and chemotherapy in general at diminished markedly.
Our expectation was that relic correlate with blood the anti apoptotic effect of cortisol activity.
Thereby resets enticing ovarian tumors to the effect of Nab Paclitaxel.
This expectation was resoundingly confirmed.
Brazil trial met its primary endpoint of improved progression free survival patients treated with <unk>, plus Nab paclitaxel experienced a 30% reduction in their risk of disease progression compared to patients treated with Nab paclitaxel alone the hazard ratio of <unk>, seven and a P value of 0.00.
<unk> eight.
At 12 months, 25% of patients in the realm of Cortland arm remained progression free almost twice as many as in the control arm.
In the interim evaluation of overall survival patients treated with <unk> plus Nab Paclitaxel had a median overall survival of 16 months compared to 11 five months for those receiving Nab Paclitaxel alone.
Hazard ratio was <unk> six nine with a P value of 0.1.
These results were obtained without the need for a biomarker diagnostic test.
Prerequisite of many currently available treatments and we're even observed in patients with particularly poor prognosis such as patients who had received multiple lines of prior therapy and patients who have progressed, while on standard of care therapy.
Railroad Korlym, plus Nab Paclitaxel was well tolerated the adverse events observed were consistent with the known safety profile at Nab Paclitaxel because patients in the realm of Korlym plus Nab Paclitaxel arm, they are better than those of the Nab paclitaxel monotherapy or they had an approximately 30% longer duration.
Of Nab Paclitaxel therapy, when adjusted for treatment duration, the safety profile umbrella Korlym plus Nab Paclitaxel was very similar to that of Nab Paclitaxel alone.
The results of the <unk> study were presented last month in an oral late breaker session at the American Society of clinical oncology annual meeting and simultaneously published in the lancet the general Medical journal with the world's highest impact factor.
Physicians have responded with great enthusiasm to these results improving progression free survival and overall survival without an added safety burden positions <unk> to become the new standard of care for patients with platinum resistant ovarian cancer.
We submitted relic Orleans NDA in platinum resistant ovarian cancer earlier, this month and will submit a marketing authorization application in Europe Sir.
In anticipation of a successful regulatory outcome, we have made substantial progress in establishing a dedicated oncology division.
We are prepared to move swiftly to bring <unk>, plus Nab paclitaxel to the women who can benefit from it once it is approved.
Brazil established relic correlates therapeutic value in a highly challenging stage of ovarian cancer.
These results support relic Orleans potentially broader utility.
<unk> in earlier stages of ovarian cancer and in other solid tumors. The first step in advancing this strategy is with our Bella trial, which is enrolling briskly and will test, whether combining rella korlym plus Nab paclitaxel with Bevacizumab offers an additional effective option for patients with platinum resistant ovarian cancer.
We will soon begin additional studies in.
In addition to explore a cortisol receptor antagonism has potential to reset amortize tumors to chemotherapy. We are evaluating its use in combination with androgen deprivation therapy in prostate cancer.
Cortisol stimulation is a major reason why patients with prostate cancer treated with the widely prescribed androgen receptor antagonist and <unk> eventually experienced resurgent disease.
Deprived of androgen stimulation their tumor switched a cortisol activity to stimulate growth.
Our collaborators at the University of Chicago are currently enrolling a randomized placebo controlled phase II trial of Birla Korlym plus <unk> in patients with early stage prostate cancer to determine a cortisol receptor antagonism can block this tumor escape route.
Another possible role of cortisol receptor antagonism is in combination with immunotherapy.
Because cortisol suppresses the immune system it may be lumpy effectiveness of cancer therapies intended to stimulate an immune response, adding.
Adding a cortisol receptor antagonist to immunotherapies, such as checkpoint inhibitors may enhance their effectiveness.
Following our phase one b trial in advanced adrenal cancer, we are deciding how best to investigate the utility of our compounds in combination with immunotherapies in other tumor types in earlier stages of cancer.
Our proprietary compounds gas at Cortland is an excellent candidate for the treatment of neurologic disorders.
While our dazzle. This trial of 249 patient randomized double blind placebo controlled phase II trial of <unk> in patients with ALS.
Did not meet its primary endpoint of improvement in the ALS functional rating scale.
The data did suggest a powerful benefit prevention of early death.
One year after entering Dazzles patients, who received 300 milligrams of <unk> daily exhibited an 84% reduction in debt the risk of death compared to patients who only received placebo.
The P value for this finding was coined 0009.
The benefit emerged in the first 24 weeks of the study during which time five week five patients randomized to placebo had died compared to no deaths in the paint in the group that received 300 milligrams of data to correlate.
An important point to know about the survival benefit is that an emergence from the start of treatment when patients still retain considerable function and quality of life.
The common understanding of a L. S is that it progresses by degrading motor function until patients are completely paralyzed with desktop all the way.
While this is true in some cases, many more patients die long before then from conditions such as pneumonia that they would have survived had it not been for their AOS.
It is these early data that patients receiving dasa cortland experienced less frequently.
We presented these notable findings last month at the European network to cure ALS annual meeting we are engaged with regulatory authorities to German the fastest path for advancing gas at Cortland.
Nash metabolic dysfunction associated Seattle, hepatitis is a serious liver disorder that afflicts millions of patients in the United States and globally.
Cortisol activity plays a role in both the initial development and progression of the disease and cortisol modulation may serve as a treatment.
Proprietary molecules Miracle Airlines has very potent activity in the liver.
Our phase <unk> study showed that miracle or rapidly reduced liver fat and improve other markers of liver health fibrosis and metabolism Mirror Cortlandt was also very well tolerated without the Gi side effects, commonly seen in patients being treated for mash.
Our randomized double blind placebo controlled phase <unk> monarch study aims to expand on our encouraging phase <unk> results monarch has two cohorts. The first cohort of patients has biopsy confirmed mash. The second cohort consists of patients with presumed mash enrolled.
Enrolment in monarch will be completed in the next few weeks and results will be available late next year.
As I said earlier this is the dawn of a new era at <unk>, Let me reiterate our important developments.
The catalyst trial, the largest and most rigorous of its kind proves that there are far more patients with hyper cordless cortisol lesson that was previously believed and that cortisol modulation is very beneficial for these patients with results from both phases of catalyst now published leading.
Physicians are recognizing the significance of the findings and joining us in raising awareness. We are certain that this will lead to many more patients being screened identified and properly treated.
While core homes effectiveness intriguing treating hyper cortisol as well establish <unk> as a substantial advance its strong efficacy and safety positions it to become a new standard of care. We expect its approval on hyper cortisol listen by the end of this year and are eager to make it available.
Immediately thereafter.
The Brazil of trials validated cortisol receptors antagonisms utility in oncology.
<unk> delivered a clear clinical benefit with no added side side effects safety burden in patients with platinum resistant ovarian cancer treated with Nab paclitaxel.
We expect rella correlates improvable in oncology next year.
We are working to unlock its potential in earlier stages of cancer other tumor types and in combination with other anti cancer agents.
In addition, we are actively exploring the potential of cortisol modulation to treat a broad range of additional severe diseases, including neurologic and hepatic diseases.
We continue to discover and develop proprietary selective cortisol modulators with likely very distinctive clinical attributes and are advancing the most promising to the clinic.
Cortisol modulations vast potential to help many patients is just beginning to unfold. It is a very exciting time at course shift.
Operator, let's proceed to questions.
Thank you.
As a reminder to ask a question you will need to press star one one on your telephone to remove yourself from the queue. You May press Star one again, please standby, while we compile the Q&A roster.
Our first question.
Come from the line of David M Film Piper Sandler. Please go ahead David.
Okay.
Thanks, So I have a few korlym specific questions.
First actually wanted to ask you about the authorized generic what portion of your business came from the authorized generic during the quarter relative to <unk> and can you talk about the pricing headwind in <unk>.
<unk> terms year over year.
So that's number one number two is just with the supply chain issues and fulfillment issues can you talk about the disconnect between prescriptions are actually written and prescriptions that are actually filled in other words, what portion of prescriptions are actually.
Written were pulled through to actually to actual filled prescriptions and did that.
Did that gap narrow.
In the second quarter in other words, where the fulfillment issues.
For lack of a better term less bad into Q.
Purses.
<unk>, so I'll stop there.
Alright, well, thanks, David I think I think we understand exactly what you're asking and I just wanted to pass you over to Sean The Duke Sean as you know is the president of our Endocrinology Division and these are things that it does translate everyday hi.
Hi, David Thanks for the questions I'm going to touch on the AG question first so if you recall on the last call. We had stated that just over 50% of our business head.
<unk> transitioned over to the AG.
Over the course of the second quarter. We're now at about two thirds of our business. So we've seen sort of that transition slow we expect over the next six months, maybe a little bit more movement, but we have seen some stabilization so percentage point here or there, but I think we will settle at the end of the year around two thirds of our business in terms of the pricing question, you asked them and when we.
Launched our AG in June of last year, we launched it at a 12% discount to.
Korlym is list price, but you know thats, a starting point with payers rate payers negotiate and so it varies by payer contract, but when you look on average across all of our contracts.
It's about a 30% discount to Korlym plus price.
Thank you Sean So now in terms of your question before I talk about the supply chain specifics I do want to spend a couple of minutes talking about the health of our business and then I'll talk specifically about the pharmacy. So we had an excellent quarter I mean, we grew our volume by 49% year over year and it could have been more on it.
I'll talk about that in a minute when I talk about the pharmacy. So why why is our business growing and why why is it so strong well first point is the market is expanding.
There has been a significant amount of data over the last couple of years, most notably catalyst and Joe referenced this in his comments, but it has made a real splash physicians are way more interested today than they were a couple of years ago. Its expanding the conversation we're getting in front of them.
In a real life example of this we monitor this of course, a real life example is at the Endo conference about three weeks ago here in San Francisco, The Endo Society Conference. We had a presentation on the catalyst data in a room that had seat for about 225 people 500 people attended.
And there are more people standing that setting and that would have been absolutely unheard of two years ago.
And here we are today, that's driving again more conversation more outreach with <unk> and we're working hard to make sure that information is disseminated broadly so that physicians are actively looking for these patients which is exactly what theyre doing there is more screening going on and.
And more patients are being diagnosed and because of that our korlym prescriptions have increased significantly.
Over over the last few months and that's just going to continue we expect.
We're just really at the start of that and to put that in perspective, I mean, we now have days that we get more korlym, new patient prescriptions than we used to get in a month.
And again, it's just the start of that we're just at the start of catalyst, we think that's going to accelerate through the rest of the year and really lay a very strong foundation for gorilla Korlym, which of course, we're very excited for which is going to come at the beginning of next year.
So in terms of your specific question around around the pharmacy I mean in short the pharmacy, just did not meet our expectations. They improved in Q2, they got closer to where we were but not all the way and the best way that I think I can explain this is to use a bit of an analogy and bear with me for a second I'm going to talk about cars for a second here.
But but assume that a few months ago Optime was operating in a car that was driving about 60 miles per hour of course that was in a car that was driving 70 miles per hour and we needed them to catch up not just catch up but sustain.
Their speed to support our business as they improve they got closer to where we work, but that's the operative word where we were is not where we are today. This is not a static business. Our business continues to grow into accelerated and we're now driving at 80 85 miles per hour. So you asked specifically you know has the gap narrowed I mean theres been such a flood of vol.
<unk> has continued to create a problem and when you look to quantify that that probably had about a $15 million impact on our second quarter results.
So heading into the second half of the year, you know where are we well we saw we saw improvement we expect that we're going to continue to see improvement in the third quarter and we expect that we're going to continue to see even more improvement with our current pharmacy vendors or through the end of the year, but as we said in our in our opening statements were also Onboarding, a second pharmacy, which we're very excited about that will support our business both today and into the future.
With <unk> and we expect them to start contributing in the fourth quarter.
Thank you <unk> next question please.
Our next question.
Come from the line.
Joon Lee of <unk> Securities. Please go ahead Jim.
Hey, Joe.
Thanks for taking our questions regarding the $3 billion to $5 billion in peak sales opportunity for <unk>.
Your hyper corticotropin franchise.
I mentioned on the call how much of that is coming from Carlin and given the pending approval of Rolla Korlym how important is it to you.
The on the ongoing appeals process with Teva.
And I have a follow up.
I'll be glad to take that question.
I want to reiterate.
A few of the points, we've made already but they are important which is that <unk> is a better medication that correlate korlym works extremely well, but relative while it had very very tangible advantages and we think that.
Oil and ultimately will entirely replace korlym.
It's also another point, which is that we think that we have penetrated a very small percentage of the overall potential market. There are many more patients with hyper for ourselves to be treated than I've ever been treated so our longer term estimates.
You referenced $3 to 5 billion certainly takes into account our ROIC correlate really hasnt some sense very little impact.
One of them at that point, but maybe it's just another important point to make which.
Don't often say out loud, if we don't think $3 million to $5 million of peak sales.
I mean, three to 5 million is what we think we can do with three to five years, but we think that this market is substantially larger than that and we will have and we will have a substantial piece of that substantial mark.
Okay. Thank you for the clarification either part of the question was around the patent please repeat the other part of the question. Another part of his question on Wednesdays winning the patent case impact of $3 billion to $5 billion.
When you add case does not impact the $3 billion to $5 billion, but impacts the five is because because thats a correlate patent case.
We think that.
Of course, maybe everyone. Our situation. We think we have a very good reason to win the patent case, but in some sense.
So looking through the rearview mirror. This is really about the advancement of rella correlate and its future growth.
Understood. Thank you so much.
Follow up when will the second pharmacy come online and at what point would you consider activating more distributors because isn't that sort of a plan for Robert Bartlett, which.
And we think both have a broader.
Adoption.
Yes, I'm going to pass it back to Sean for that answer yes. So thanks for the question. So the onboarding of that pharmacy is in process and we expect them to two.
Contribute sort of value and have an impact in the fourth quarter.
To your second question and comment we had always planned to expand this network for for <unk> and it really was the surge of demand that we saw with korlym that caused us to sort of pull that back a quarter and that's why we're accelerating this but to your question about will we expand further it's something that we're looking into I mean, we're being very thoughtful as we.
Set up our current structure with the addition of the second pharmacy. So that we have the ability to to add to that should we see see fit so something we're always looking at and we will we will do that if we see fit into.
Into the future.
Thank you. Thank you.
Next question please.
Thank you.
Our next question.
Comes from the line of.
Will you offer cooler raw Mccann.
CW. Please go ahead.
Okay. Thank you hi.
A couple of quick questions.
Yes so.
<unk>.
You have initiated the cabinets Judy.
A couple of years ago, you were even before.
And are you kind of confidence.
So again the data I was going to come from catalyst you can see where all this out there.
The patients are not being identified as much as it should be.
Having.
That I'm, leading to that question is.
What kind of.
What steps mist and not having a second pharmacy onboard earlier in time, because you knew that there was going to end up surge of demand.
Demand.
From the market.
Once the data comes out.
And the other question is.
On the.
The expectation that the second pharmacy is going to come on board in the fourth quarter.
Why are we still pulling down.
The guidance does that mean, there is something else that we are not understanding.
Okay, Let me see if I can order those questions I think I'll try the first question.
I'll keep Sean D. The second question first question is why didn't we get it for a second.
Behind sooner and.
I'll be honest hindsight 2020.
Good question and I think that part of it was that.
Sort of a combination of things the build from the catalyst information has gotten much more rapidly than we thought.
And frankly, we thought that our original pharmacy would be able to keep up and.
Live and learn the demand has been even greater than we thought it was and our current pharmacy wasn't able to stay with it.
Sure on the second question, Yes. So the second question was given the second pharmacy coming on.
And I think value in the fourth quarter of <unk>.
Change so look we take all factors into account when we when we look at our range and one of the challenges is.
As I mentioned earlier, the impact of the patient delays and that's what's happening here and it's taking longer for patients who are Medicaid medication.
It was a $15 million impact in the second quarter, but that doesn't just go away I mean that sort of flows flows through the model. It takes longer to start patients it takes longer to titrate up and when you do sort of the math throughout the course of the year. It has the potential to be a larger impact than that 50%. So that was the main driver yes.
Thank you Sean.
Thank you so much clarity.
Thanks, a lot sure Rockies.
On the.
On the balance study.
What's the timeline for that.
And also in terms of your.
Graduating uralic cortland in other solid tumors.
Is that basically the prostate cancer that you're talking about.
There are no.
Solid tumors that you would be looking at.
Well. Thank you very much for asking that are quick and that gives me an opportunity to reintroduce you to build guy here, who is our chief development Officer. This is all his domain and let them get started alright. Thanks RK for that question. So for the pellet trial.
Yes.
Enrollment has gone better than expected I mean, our phase II and our phase III studies, using Korlym plus Nab Paclitaxel enrolled also very quickly. This is growing even faster than that and so we will have this study enrolled by the end of this year and therefore, we will see results.
About a year after that.
And when it comes to.
Other solid tumors, you know I'll comment on there yet prostate cancer is one of those but we're thinking much bigger than that because our vision for al correlates to establish its role as an agent capable of synergizes with many other agents to enhance efficacy with no added toxicity in many different tumor types now on the near term.
Going to study and move forward and looking at that.
Moving up in the treatment paradigm in ovarian cancer, and we will be expanding in cros gynecological oncology spaces, like endometrial cancer and cervical cancer and when we look at other solid tumors I'll give you more details in the coming in the coming weeks by the end of this year, but we're going to be also looking at other selective group of course.
Card receptor antagonist in combination with other agents like immunotherapy. So finalizing our oncology development plans is ongoing we've got a great plan and.
And we will give you the details very soon.
Thank you and the last question from me Joe.
Yes on the.
Condensation.
On R&D.
Right.
Did you already have that conversation with the FDA.
If not.
What's the strategy there do you think.
Soon as you get.
You get get get them.
No agreed for the study would you be doing that in a city or would you want to utilize whatever data you have to file.
Yes.
We heard and understand your question.
Pass it back to Charlie Robb currently as our Chief business Officer, and he oversees all of our regulatory interactions.
Okay. So.
We have not yet had the meeting we said in the last call that we were going to contact the regulators.
Immediately, which we did and so we have a meeting scheduled later in August to discuss the path forward.
And one of the options is certainly.
An approval based on the data we have now.
That would be an unusual thing that one should count on but thats. What we are putting that forward is a very serious possibility in a subject of conversation with regulators.
The other of course would be the.
The design of a confirmatory trial, which we would expect to conduct in any event.
Whatever the use of the phase II data, we have now turns out to be so when we.
Have that meeting and our.
So on our plans, we will let folks know about it but that's sort of the state of play right now.
Thank you thank you Charlie.
Sure.
Good luck and talk to you guys.
Yes, thanks, thanks for the questions.
Yes. Please. Thank you. Our next question comes from the line of Edward Nash with Canaccord Genuity. Please go ahead Edward.
Hi, good afternoon.
Oh for Edward Thanks for taking our questions.
My questions are Jorge my questions are focused on the floor.
Resistant ovarian cancers.
So the first part of my question maybe.
Could you help us understand is well positioned.
The current treatment paradigm.
Because you know you mentioned that.
It is the expectation that rollout can help treat the earlier stages of ovarian cancer. So does that also includes patients that are platinum resistant.
Yes, I think I caught most of your question.
And if we missed anything efficacy.
Verify but I'd like to introduce everyone to Roberto <unk>, who is our president of our oncology Division and he he is all over this material. So pleased that Roberta start and if we've missed something.
Let us know.
Thank.
Thank you. Thank you for the question. So let me just start by saying that since we have presented our data at <unk>. We have had the opportunity to speak with a wide range of key opinion leaders in the field.
We have also ran a comprehensive market research getting input from a larger number of treating physicians across all major U S regions and the feedback on the roads or the result has been very very encouraging to us. It is speaks really to the strength of the data. We have so we are very confident about our path to market leadership.
Typically in platinum resistant ovarian cancer, and we believe <unk> has the potential to deliver over $1 billion in long term revenues.
Now specifically to your question about positioning there was other trial data supports Rockwell Linda is a flexible option that can be used in multiple lines of therapy before.
Before and after biomarker specific agents like yellow here for example, which was very much corroborated by the market research I alluded to before.
Okay. Yeah. Thanks, that's very helpful.
So I guess do you think you already mentioned, maybe squeeze in a follow up over here.
A discussion with physicians.
Being that they will tend to use rail Macquarie.
The earlier stage patients or rather to preserve or sort of preserve it rod for late stage patients because of it.
Safety profile with you.
Positive.
These patients usually theres not that many options out there.
Please Roberto yes, so oh in theater as you know look since you.
Patients with multiple lines of therapy early than late.
It supports flexible utilization as I mentioned before but as we speak to physicians about this.
Not just the efficacy they actually looking to that safety is a very strong attribute of this regimen and the oral as well. It's also something that really appeals to them. So we see significant utilization in earlier lines of platinum resistant ovarian cancer and potential for utilization even earlier.
Data evolve.
And I would just like to add to the one point that bill alluded to.
I think that our trial in platinum resistant ovarian cancer Brasil enrolled twice as fast as any other study, which as every bank completed in that disease and I think that.
The current study the Dallas study, we really have to keep up I mean, the enrollment is really still risk there and I think it speaks to the ease of use of this drug.
So.
Yes.
We're we've done our research and we're only speculate until we actually get to the market, but it seems as if physicians kind of all along the spectrum of disease severity are interested.
Okay.
Okay great.
Very last part of my question is regarding.
Regarding rollout.
With the potential of <unk> in combination with other therapies like immunotherapy as you mentioned before or ADC in the future any specific concerns overlapping.
Hudson city's over here.
I'm going to give you to bill Gaia.
Yeah. Thank you for that question no. There are absolutely no concerns of overlapping toxicities.
We look to see again to be the agent of choice in combination with any immunotherapy of chemotherapy and we will do that in many future studies to come to prove that.
And there really is no mechanistic reason to think that beyond that.
That problem.
So it looks like we're out of questions. Thank you very much for.
Everybody who has.
Has called in we look forward to really what's next is.
I really do view this personally it's an exceptionally exciting time, we really have an opportunity to help many many people and you'll be a part of it. So thank you very much and we'll talk to you next quarter.
Okay.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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Okay.
Okay.