Q3 2020 Corcept Therapeutics Inc Earnings Call

November 3, 2020

[music].

Good day and welcome to the Corset Therapeutics Conference call today's call is being recorded to signal for questions. Today. Please press star one and at this time I'd like to turn the call over to told me Rob. Please go ahead.

Operator: Good day and welcome to the Corcept Therapeutics conference call. Today's call is being recorded. To signal questions today, please press star 1. And at this time, I'd like to turn the call over to Charlie Robb.

Operator 3: Good day, and welcome to the Corcept Therapeutics conference call. Today's call is being recorded. To signal for questions today, please press star one. At this time, I'd like to turn the call over to Charlie Robb. Please go ahead.

Operator: Good day, and welcome to the Corcept Therapeutics conference call. Today's call is being recorded. To signal for questions today, please press star one. At this time, I'd like to turn the call over to Charlie Robb. Please go ahead.

Operator: Please go ahead. Thank you. Good afternoon, everyone.

Thank you good afternoon, everyone.

Charlie Robb: Thank you. Good afternoon, everyone. I'm Corcept's Chief Financial Officer. Today, we issued a press release announcing our financial results for the Q3 and providing a corporate update. A copy is available at Corcept.com. Complete results will be available when we file our Form 10-K with the SEC. Today's call is being recorded. A replay will be available through 17 November 2020 at 1-888-203-1122 in the United States and 1-719-457-0820 internationally. Passcode will be 680-0706.

[laughter] Chief Financial Officer.

Gary Charles Robb: I'm Corcept's Chief Financial Officer. Today we issue a press release announcing our financial results for the third quarter and providing a corporate update. A copy is available at Corcept.com. Complete results will be available when we file our Form 10-2 with the FTC. Today's call is being recorded. A replay will be available through November 17, 2020, at 1-888-203-1112 in the United States and 1-719-457-0820 internationally; the passcode will be 680-0706.

We issued a press release announcing our financial results.

Right.

A copy is available.

[laughter].

[music].

In Q1, yes, you see they.

Today's call is being recorded replay will be available through November.

2021, 80, they choose there are three 1.12.

Hey.

One 7.9.

Yeah really.

Internationally.

It would be six or seven.

Six.

Hi, good strangers cool [laughter].

Gary Charles Robb: Statements during this call, other than statements of historical fact, are correlative 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 imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs, the availability of PPE treatments, including generic versions of Coraline, the initiation or optimal mitigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Coraline, and risks related to the development of our product candidates The impact of the COVID-19 pandemic on our employees, consultants, and vendors, as well as on physicians, patients, insurers, regulators, and the practice of medicine in general. These and other lists are set forth in our SEC files, which are available on our website and the SEC website.

Charlie Robb: 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 might cause actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs. The availability of competing treatment, including generic versions of Korlym, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance coverage, and reimbursement for Korlym, and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight, and other requirements.

Stuart.

These statements are based on our plans expectations and are subject to risks and uncertainty, which may cause actual results to differ materially no such statements Express.

These risks and uncertainties include.

Right.

[laughter] keyboard goal sprinkled in.

And thereafter.

Hi, Jerry.

Reserves sufficient.

Great.

The Danville.

[laughter] Harrisburg corridor.

She interacts with each.

We're going to do anything crazy.

He covered reimbursement.

Risks related to the development of our product candidates, including the critical need regulatory approval mandates oversight.

Names like Nike and to make our boys, so vendors as well as our vision patients insurance regulators.

Charlie Robb: The impact of the COVID-19 pandemic on our employees, consultants, and vendors, as well as on physicians, patients, insurers, regulators, and the practice of medicine generally. These and other risks are set forth in our SEC filings, which are available at our website and the SEC website. On this call, forward-looking statements include those concerning our revenue guidance, cash flow, and expected growth, our stock repurchase program, and its intended funding sources. The impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers, and patients, and expectations regarding our financial reported performance and clinical development program after the COVID-19 pandemic are further detailed. Physician awareness of hypercortisolism and the selection of Korlym as the optimum medical treatment, the timing, cost, and outcome of litigation, including our lawsuits against Teva Pharmaceutical and Sun Pharmaceutical.

Hey, Josh.

These and other risks.

That's interesting.

Sure available at our website <unk>.

On this call, but what do you think that's including those concerning our revenue guidance cash flow expected.

Gary Charles Robb: On this call, forward-looking statements include those concerning our revenue guidance, cash flow, and expected growth, our stock re-purchase program, and its intended funding sources; the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers, and patients, and expectations regarding our financial performance and clinical development program after the COVID-19 pandemic's broader control. Physician awareness of hypercortisolism and the potential correlation with the outcome of medical treatment. Timing, cost, and outcome of litigation, including our lawsuits against telepharmaceuticals and Sun Pharmaceuticals. Intended challenge to the validity of one of our patents, for the patent trial and appeal court. The scope and effective power of our intellectual property.

Our stock repurchase program and the funding sources impact like it and then it kind of local operations financial reforms clinical development programs physicians payers and patients and expectations regarding our financial report.

In clinical development program after the couldn't make <unk> border control. They should awareness of Piper of course always in the fourth quarter. When is the optimal treatment. So I mean cost now HM no lawsuits again.

Okay.

That was challenged the validity of water.

Charlie Robb: Teva's challenge to the validity of one of our patents before the Patent Trial and Appeal Board, scope and effective power of our intellectual property, the benefits of orphan drug designation, the progress, enrollment, timing, design, and results of our clinical trials, and the clinical and commercial attributes of Korlym, Relacorilant, Miricorilant, and our other selected cortisol modulators. We disclaim any intention or duty to update forward-looking statements. Revenue for the Q3 was $86.3 million, a 6% increase from the Q3 of 2019. Q3 GAAP net income was $21.6 million compared to $26.3 million in the same period last year.

And I think trial.

School bus powered by local property benefit the orphan drug designation apartments enrollment timing right.

Gary Charles Robb: The benefits of working drug designation. The progress, enrollment, timing, design, and results of our clinical trials. And the clinical and commercial attributes of our correlates, extracorrelates, mirror correlates, and our other selected cortisol modules. We disclaim any intention or duty to upset or offend you. Revenue for the third quarter was $86.3 million, a 6% increase from the third quarter of 2019. The third quarter gap in income was $21.6 million compared to $26.3 million in the same period last year.

The trial.

Commercial.

Well actually the core like no.

Other selected.

We disclaim any intention or duty.

Sure.

Revenues for the third quarter was $86.3 million, a 6% increase from the third quarter.

Third quarter GAAP net income was $21.6 million compared to 26.3 <unk> same period last year, excluding non cash expenses related to stock based compensation good utilization for [laughter] doubling the related income tax effects non-GAAP net income for the third quarter was $30 million.

Charlie Robb: Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in Q3 was $30 million compared to $37.8 million in Q3 of 2019. Our cash and investments were $444.2 million as of 30 September, an increase of $34.7 million from 30 June. On consideration of our strong financial position and prospects, our board of directors has approved a program running through 30 September 2021 to repurchase up to $200 million of our common stock. We will determine the timing and size of any repurchases based on market conditions, our stock price, and other factors.

Compared to $37.8 million in the third quarter.

Gary Charles Robb: Including non-cash expenses related to stock-based compensation, consumerization of deferred taxes, Unknown Attendee, Swayampakula Ramakanth, Gary Robb, Joseph Belanoff, Gregory Fraser, and all consideration of our strong financial position and prospects, our Board of Directors has approved a program running from September 30, 2021, to repurchase up to $200 million of our common stock. We will determine the timing and size of any We believe revenue from our cashew syndrome business, together with our cash on hand, will be sufficient to fund our commercial activities in our current and planned clinical development and drug discovery programs, as well as our program to repurchase $200 million of our common stock. [inaudible] In March 2018, we sued Tefla Pharmaceuticals and the Federal District Court to stop it from marketing a generic version of Coraline in violation of our patent.

Our cash and investments were $144.2 million.

Are you seeing there.

$4.7 million.

Oh consideration about start financial position and prospects Board of directors is pretty good program running through September Thirtyth, we plan to repurchase up to $200 million are common stock will determine the timing and size of any repurchases based on market conditions, our stock price and other factors.

Let me briefly Mukherjee syndrome business, you guys are going to catch up.

Charlie Robb: We believe revenue from our Cushing's Syndrome business, together with our cash on hand, will be sufficient to fund our commercial activities and our current and planned clinical development and drug discovery programs, as well as our program to repurchase up to $200 million of our common stock. Now, a brief legal update. In March 2018, we sued Teva Pharmaceutical in Federal District Court to stop it from marketing a generic version of Korlym in violation of our patents. Our lawsuit stayed final FDA approval of Teva's proposed product for 30 months, a period which ended on August 1. Discovery is underway. Originally, trial was set to begin February 2, 2021. Last month, the court vacated that date and ordered the parties to complete trial preparation by March 17, 2021. A new trial date has not been set.

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Hello.

March 2018, we do just pharmaceuticals in Federal District Court stuff like the nerd GERD that korlym in violation of our path.

Our lawsuits.

Do you think that those product for three months period ended on August 1st Discovery is underway originally problems at the beginning February 2021 last month the court vacated.

Parties to complete.

March 17th.

Gary Charles Robb: Our lawsuits stayed final FDA approval of those products for 30 months, a period which ended on August 1st. Discovery is underway. Originally, the trial was set to begin February 2nd, 2021. Last month, the court vacated that date and ordered the parties to complete trial preparations by March 17th, 2021. A new trial date has not been set. It could take place any time after March.

And it's probably not guidance that you can take place anytime after March 17.

Charlie Robb: It could take place any time after 17 March. Teva has also challenged the validity of one of our patents, the '214 patent, in a proceeding known as a post-grant review or PGR before the US Patent Office's Patent Trial and Appeal Board or PTAB. As many of you know, oral argument in this matter was heard on 2 September. We expect the PTAB to produce its decision on or about 19 November. The losing party may appeal to the Federal Circuit Court of Appeals, during which time the patent will remain in force. It is important to note that Teva is barred from challenging the validity of the '214 patent in the district court case using arguments it raised or could have raised in the PGR.

I mean, it's always a challenge them to that whatever the.

Did you get for it.

Proceeding to how did they granted you were P.G.R. before the U.S. and Austin, probably appeal board or.

Many of you know oral argument in this matter was heard on September 2nd.

We expect to do that.

<unk> decision on or about November 18.

The party May appeal to the Federal Circuit Court of Appeals during which time the basket.

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Gary Charles Robb: Kevin has also challenged the validity of one of our patents, the 214 patent, in a proceeding known as a Post-Grant Review, or PGR, before the U.S. Patent Office's Patent Trial and Appeals Board, or PDAC. As many of you know, oral argument in this matter was heard on September 2nd. We expect the PSAB to produce its decision on or about November 19th. The losing party may appeal to the Federal Circuit Court of Appeals, during which time the patent will remain in force. [inaudible] It's important to note that Teva is barred from challenging the validity of the 214 patent in the district court case using arguments it raised or could have raised in the PGR. While Teva's attorneys will undoubtedly try to do so anyway, the rules are intended to prevent Teva from getting a second bite at that outcome. In any event, appeals to the Federal Circuit usually take about 12 to 16 months to resolve.

It's important to note that todays BARDA.

Barred from challenging the validity of that you know.

In the District Court case <unk> arguments raised.

Could have raised guidance.

Well, it's never the journey going down to try to do so anyway.

Charlie Robb: While Teva's attorneys will undoubtedly try to do so anyway, the rules are intended to prevent Teva from getting a second bite at that apple. In any event, appeals to the Federal Court could easily take up 12 to 16 months to resolve. Should an appeal takes place, the soonest we expect definitive resolution of the PGR is Q4 2021. Sun Pharmaceutical is also seeking to market generic Korlym. Our lawsuit against Sun to stay final FDA approval of Sun's proposed product till the earlier of 8 December 2021, that is December eighth of next year, or a decision by the District Court that the patents we have asserted against Sun are invalid, unenforceable, or not infringed. Our dispute with Sun is separate from our litigation against Teva and is following its own timeline.

These are intended to prevent them from getting a second [laughter].

Anything is possible.

You would think about 12 to 16 months to resolve.

So you shouldn't see appeal takes place. It's just me speaking to pending resolution each yard [laughter].

2021.

It was like you don't see even more generic.

Our loss due to give some guidance the final after you do this I'm sorry.

So the early December 2021 that is December next year or do you see somebody district courts at the time.

The guidance on are invalid and sports are not right.

You would assign a separate litigation against its probably its own timeline.

Certainly hearing it's Vacates what set for November of this year that they been vacated new date.

Charlie Robb: A Markman hearing in the Sun case was set for November of this year, but that date has been vacated, and a new date has not been entered. In addition, no trial date has been set. Predicting the timing of any district court litigation is difficult, and the possibility of delays caused by the COVID-19 pandemic compounds the problem. The court has vacated our original trial date with Teva but has not set a new one. Whenever this trial takes place, we'll be ready. We look forward to putting our case before the judge. I will now turn the call over to Dr. Joseph K. Belanoff, our Chief Executive Officer. Joe? Thank you, Charlie.

In addition, no trial date has been set.

He was talking to me District Court litigation difficult absolutely delays caused by the cobot Nike endemic How's the problem.

<unk> became the original trial date.

Not that anyone.

This trial takes place in the USA with sports betting RP gosh I.

I will now turn the call over to John.

Gary Charles Robb: Such an appeal will take place as soon as we expect definitive resolution of the PGR in the fourth quarter of 2021, and Pharmaceutical Inc. All of us use the market generic quorum. Our lawsuit against Sun, and the final FDA approval of Sun for its proposed product shall be earlier on December 8th, 2021, that is, December 8th of next year, for a decision by the district court that the patents we have asserted against Hunter are invalid, unenforceable, or not comprehensive. Our dispute with SIN is separate from our litigation against TEVA, and it's following its own timeline. Martin Leary and his sidekicks had set for November of this year, but that date has been vacated, and a new date is not possible.

Good.

Sure.

Thank you Charlie.

Joseph Belanoff: Thank you, Charlie.The challenge posed by the COVID-19 pandemic underscored just how fortunate Corcept is to have built a stable commercial business profitable enough to fund our increasingly broad and advanced clinical development program. We are currently testing molecules from our portfolio of proprietary selective cortisol modulators in two phase 3 Cushing's syndrome trials, one phase 3, one phase 2, and two phase 1b oncology trial, and two, soon to be 3, phase 2 trials in metabolic disorders. These trials will generate important data next year into 2022, even as additional novel molecules enter development. I know of no other company our size that combines commercial success with such diverse and promising clinical activities. I hardly need to tell you these are difficult times for everyone.

Joe Let me close by.

Joseph K. Belanoff: The challenge posed by the COVID-19 pandemic underscored just how fortunate Corcept is to have built a stable commercial business profitable enough to fund our increasingly broad and advanced clinical development program. We are currently testing molecules from our portfolio of proprietary selective cortisol modulators in two phase 3 Cushing's syndrome trials, one phase 3, one phase 2, and two phase 1b oncology trial, and two, soon to be 3, phase 2 trials in metabolic disorders. These trials will generate important data next year into 2022, even as additional novel molecules enter development. I know of no other company our size that combines commercial success with such diverse and promising clinical activities. I hardly need to tell you these are difficult times for everyone. The COVID-19 pandemic has caused many individuals, including physicians and patients, to protect themselves from infection, most commonly by limiting their exposure to other people.

19.

The school that just don't watch it of course it is.

We'll see what the Workkit business, probably about increasingly broader bands clinical development programs.

We are currently testing molecules like football.

Very selective cortisol modulators cig, two stage revision CPL trials, well it'd be great one face to face to face wouldn't be oncology trial into there seem to be pretty phase two trials and metabolic disorders. These trials will generate important data.

Next year.

Even as additional novel about that.

Yes.

No it's not.

Our size, it's a nice commercial success.

Honestly.

Yes.

Pardon me to tell you that in difficult times for everyone.

They came back to us many individual physicians and patients can protect themselves production was college.

Joseph Belanoff: The COVID-19 pandemic has caused many individuals, including physicians and patients, to protect themselves from infection, most commonly by limiting their exposure to other people. Patients are reluctant to leave their homes even to see their physician. Many medical practices have barred or sharply limited in-person visits by commercial representatives. This reduction in face-to-face interactions makes every aspect of medical care more difficult, especially for a complex serious condition such as Cushing's syndrome. We are doing what we can to help. Our commercial team has devised ways to support physicians by video and teleconference.

Gary Charles Robb: In addition, no trial date has been set. Predicting the timing of any district coordination is difficult, and the possibility of delays caused by the COVID-19 pandemic compounds the problem. The court has vacated our original trial date with PEPA, but has not set a new one.

That's the other people.

Patients are reluctant to leave their phones you see their position.

Joseph K. Belanoff: Patients are reluctant to leave their homes even to see their physician. Many medical practices have barred or sharply limited in-person visits by commercial representatives. This reduction in face-to-face interactions makes every aspect of medical care more difficult, especially for a complex serious condition such as Cushing's syndrome. We are doing what we can to help. Our commercial team has devised ways to support physicians by video and teleconference. Physicians have increased their use of telemedicine and have adapted their in-office procedures to reduce the risk of infection. However, these measures are an imperfect substitute for face-to-face type of care. Diagnosing and treating patients with Cushing's syndrome requires multiple in-person interactions between patients and physicians. Nevertheless, patients who were using Korlym before the pandemic are highly motivated to continue to use it.

No that was just a ballpark.

Many of you in person.

Representatives.

[laughter] face to face interactions. It's every aspect the problem here really difficult, especially for Oh, I'm serious conditions, such as Cushing syndrome.

Joseph K. Belanoff: Whenever this trial takes place, we will be ready. We look forward to putting our case before the judge. I will now turn the call over to Dr. Thank you, Charlie.

You're getting what we got to help our commercial teams to buy wages what positions, but how.

In addition to increased their views and tell them that said that adopted there as well.

Joseph Belanoff: Physicians have increased their use of telemedicine and have adapted their in-office procedures to reduce the risk of infection. However, these measures are an imperfect substitute for face-to-face type of care. Diagnosing and treating patients with Cushing's syndrome requires multiple in-person interactions between patients and physicians. Nevertheless, patients who were using Korlym before the pandemic are highly motivated to continue to use it. Despite the current pandemic-caused obstacles, we continue to enroll new patients and add to our roster of Korlym prescribers, albeit at a muted pace, for one reason.

Office procedures to reduce the risk section.

Joseph K. Belanoff: The challenge posed by the COVID-19 pandemic underscores just how fortunate Corcept is to have built a stable commercial business properly adapted to our increasingly broader advanced clinical development program. They are currently testing models using a portfolio of proprietary selective cortisol modulators in two phase 3 Cushion Syndrome trials, one phase 3, one phase 2, and two phase 1B oncology trials, and two, soon to be three, phase 2 trials in metabolic disorders. These trials will generate important data next year and in 2022, even as additional novel models develop. I know of no other company our size that combines commercial success with such diverse and promising clinical activities. I heartily need to tell you that these are difficult times for everyone.

Uh huh.

Yes.

Yeah.

They are going to treating patients with <unk>.

Pardon me.

Yes.

Less patients who are using quotas.

Hi, Dave.

To continue to use.

Despite the card and debit card obstacles.

Joseph K. Belanoff: Despite the current pandemic-caused obstacles, we continue to enroll new patients and add to our roster of Korlym prescribers, albeit at a muted pace, for one reason. Korlym is an effective treatment that has greatly improved the lives of many patients with Cushing's syndrome, a life-threatening chronic illness. Pandemic-related changes in medical practice and patient behavior modestly reduced our revenues this quarter. The foundation of our business, an effective medication promoted by a dedicated commercial team that puts the interests of patients first, remains rock solid and is poised to support significant growth once conditions improve. As I have said on prior calls, there are many patients who could benefit from Korlym who have not yet received it. Our planned successor to Korlym, Relacorilant, has the potential to benefit many more. The stock repurchase program we announced today reflects our board's confidence in the fundamental strength of our business.

All these patients were roster describes albeit we needed taste or one region.

One of them is an effective treatment that is greatly improved the lives they agencies.

Joseph Belanoff: Korlym is an effective treatment that has greatly improved the lives of many patients with Cushing's syndrome, a life-threatening chronic illness. Pandemic-related changes in medical practice and patient behavior modestly reduced our revenues this quarter. The foundation of our business, an effective medication promoted by a dedicated commercial team that puts the interests of patients first, remains rock solid and is poised to support significant growth once conditions improve. As I have said on prior calls, there are many patients who could benefit from Korlym who have not yet received it. Our planned successor to Korlym, Relacorilant, has the potential to benefit many more. The stock repurchase program we announced today reflects our board's confidence in the fundamental strength of our business.

Life, threatening chronic illness and.

And then related changes in debt.

The patient behavior.

He's already this quarter, but it doesn't change.

[laughter] dedication and notified dedicated commercial team interests.

It's Rob so it supports it.

Once conditions.

As I said on prior calls there are many patients who could benefit from korlym.

Joseph K. Belanoff: The COVID-19 pandemic has caused many individuals, including physicians and patients, to protect themselves from infection, most commonly by limiting their exposure to others. Patients are reluctant to leave their homes, even to see their physicians. Many medical practices have bars or structures and many in-person visits by commercial representatives. This reduction in face-to-face interactions makes every aspect of medical care more difficult, especially for a complex, serious condition such as Cushing's. However, we are doing what we can to help. Our commercial team is devising ways to support physicians through video and teleconferencing. Physicians have increased their use of telemedicine and have adapted their in-office procedures to reduce the risk of infection. However, these measures are being carried out very stealthy.

Not yet received.

Our plans successor to correlate well of course that's.

That said the catch up benefit anymore.

Stock repurchase program, we announced today that supports competence fundamental strength of our business most important use of our cash flow.

Joseph K. Belanoff: The most important use of our cash is to fully fund our commercial operations and our increasingly broad clinical development programs. With those needs met, our stock repurchase program allows us to purchase our stock when we think it is undervalued, like we think it is now. As many of you know, we are evaluating Relacorilant, our planned successor to Korlym, for patients with Cushing's syndrome in two phase 3 trials. Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect by inhibiting cortisol at the glucocorticoid receptor, GR for short. Unlike Korlym, it does not bind to the progesterone receptor, PR, which means it does not cause off-target effects, including termination of pregnancy, endometrial thickening, vaginal bleeding caused by activity of that receptor.

Joseph Belanoff: The most important use of our cash is to fully fund our commercial operations and our increasingly broad clinical development programs. With those needs met, our stock repurchase program allows us to purchase our stock when we think it is undervalued, like we think it is now. As many of you know, we are evaluating Relacorilant, our planned successor to Korlym, for patients with Cushing's syndrome in two phase 3 trials. Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect by inhibiting cortisol at the glucocorticoid receptor, GR for short. Unlike Korlym, it does not bind to the progesterone receptor, PR, which means it does not cause off-target effects, including termination of pregnancy, endometrial thickening, vaginal bleeding caused by activity of that receptor.

Our commercial operations and our increasingly broad clinical development programs.

This means that our stock repurchase program allows to stockholders.

Oh, yes.

Thank you.

As many of you know.

Valuating Korlym uplift successor to quell agent.

In two phase three trials really correlate to selective cortisol modulators.

Cool Jesus.

With all this.

Yeah sure.

Oh.

I'm just sort of books. So she is not caused well that's the termination of pregnancy.

Yes, absolutely so.

Joseph K. Belanoff: Diagnosing and treating patients with Pudding Syndrome requires both of them to report their new actions to see if patients exist. Nonetheless, patients who are using Quoro before the pandemic are highly motivated to continue to use it. Despite the current pandemic-caused obstacles, we continue to enroll new patients and enter a roster of prescribers, albeit at an immediate pace, for one reason or another. Hormone therapy is an effective treatment that has greatly improved the lives of many patients with kidney disease. A Life-Threatening Chronic Illness. Endemic-related changes in medical practice and patient behavior modestly reduced our efforts this quarter.

So.

Hi, different that is a real well it also decide here because I go TV.

Joseph K. Belanoff: By a different mechanism, Relacorilant also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym's pivotal trial. Korlym-induced hypokalemia is a leading cause of Korlym discontinuation. Relacorilant's phase 2 clinical data was clearly positive. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing's syndrome. There were no Relacorilant-induced instances of endometrial thickening, vaginal bleeding, and also no drug-induced hypokalemia. A poster presenting these results can be found at the Investors/Past Events tab of our website. We expect Relacorilant's phase 3 GRACE trial to serve as the basis for our NDA submission in Cushing's syndrome. GRACE continues to enroll patients with any etiology of Cushing's syndrome, although as we have stated before, the pandemic has slowed its pace.

Joseph Belanoff: By a different mechanism, Relacorilant also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym's pivotal trial. Korlym-induced hypokalemia is a leading cause of Korlym discontinuation. Relacorilant's phase 2 clinical data was clearly positive. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing's syndrome. There were no Relacorilant-induced instances of endometrial thickening, vaginal bleeding, and also no drug-induced hypokalemia. A poster presenting these results can be found at the Investors/Past Events tab of our website. We expect Relacorilant's phase 3 GRACE trial to serve as the basis for our NDA submission in Cushing's syndrome. GRACE continues to enroll patients with any etiology of Cushing's syndrome, although as we have stated before, the pandemic has slowed its pace.

[noise] serious side effects experienced by 44%, which is well instead of the trial.

Well I think you said the PB <unk> is a leading cause.

Just a few age.

Well the core launch phase two clinical data was clearly.

Agents experienced meaningful improvements I mentioned this betrayal slowed in a variety of other sites.

There were no real sparling induced in Indonesia, if anything that we're seeing.

Also no drug and you say okay.

Oh, presenting these results can be bad at the investors slide past events.

Website.

We expect Relamorelin space Threed raise trial served as the basis for our NDS, Michigan.

Joseph K. Belanoff: But the foundation of our business, an effective medication promoted by a dedicated commercial team that puts the interests of patients first, remains rock-solid and poised to support significant growth once continued. As I said on prior calls, there are many patients who could benefit from Coelho who have not yet received it. Our plan's success here at the core level has the potential to benefit many more. The solid repurpose program we announced today reflects our board's confidence in the fundamental strength of our business. The most important use of our cash is to fully fund our commercial operations and our increasingly broad clinical development program. If there is a need to raise capital, our stock repurchase program allows us to purchase our stock when we think it is undervalued.

Race continues to enroll patients etiology of Cushing syndrome, although these days.

Yes, yes.

It's definitely a India second quarter Twentytwenty chip.

Joseph K. Belanoff: We expect to submit our NDA in Q2 2022. Last quarter, we dosed the first patient in Relacorilant's second phase 3 trial in patients with Cushing's syndrome, the GRADIENT trial. GRADIENT is specifically studying Relacorilant's effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome often experience a less rapid decline, but ultimately their health outcomes are poor. GRADIENT is the first controlled study in patients with this type of Cushing's syndrome. We expect its findings will contribute to the optimal treatment of these patients. Patient participants in GRADIENT will receive either Relacorilant or placebo for 22 weeks. The primary endpoints are statistically significant improvements in hypertension or glucose metabolism. All of the other common manifestations of Cushing's syndrome will also be measured.

Joseph Belanoff: We expect to submit our NDA in Q2 2022. Last quarter, we dosed the first patient in Relacorilant's second phase 3 trial in patients with Cushing's syndrome, the GRADIENT trial. GRADIENT is specifically studying Relacorilant's effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome often experience a less rapid decline, but ultimately their health outcomes are poor. GRADIENT is the first controlled study in patients with this type of Cushing's syndrome. We expect its findings will contribute to the optimal treatment of these patients. Patient participants in GRADIENT will receive either Relacorilant or placebo for 22 weeks. The primary endpoints are statistically significant improvements in hypertension or glucose metabolism. All of the other common manifestations of Cushing's syndrome will also be measured.

Last quarter, we just first patient Relamorelin second phase three trial for patients with Cushing syndrome.

[laughter] trial really it is just we studied Billboards index. It's just getting syndrome is caused by the drain.

Worked with Asia Asia.

I was just wondering if Cushing syndrome, although we experienced less rabbit Oh Oh.

Definitely their health outcomes are poor.

Ladies boots controlled study patients with Cushing syndrome.

Thanks, its findings will contribute to the optimal treatment these patients.

Joseph K. Belanoff: Thank you. As many of you know, we are evaluating Willow Coraline, our plant successor to Coraline for patients with Gray's Syndrome, in two phases. Relative Correlation to Selective Cortisol Inhibition, Like Coraline, if she is in effect, I can give you a clue as to all the degrees of Coraline Receptor. She and I are, for sure.

Participants ladies or she is irrelevant.

She though like in two weeks.

Yes, like I said.

Just for the midst hypertension.

Oh, we have a college education Cushing syndrome walls.

Well, there's 140 patients at sites in the United States Junior.

Joseph K. Belanoff: Planned enrollment is 140 patients at sites in the United States and Europe. Many of the investigators who are participating in GRACE will also participate in GRADIENT. You can find our poster presentation of GRADIENT's design at the Research and Pipeline/Publications tab of our website. Our oncology program originated in theories postulated by investigators at the University of Chicago more than 10 years ago. It now consists of 4 clinical trials, 2 of which will produce data in H1 of next year. Our program is examining each of the 3 mechanisms by which cortisol modulation may help treat patients with solid tumors. Cortisol suppresses apoptosis, the programmed cell death chemotherapy is intended to induce. There's compelling preclinical and clinical data suggesting that Relacorilant can help chemotherapy reach its full potential by blunting cortisol's anti-apoptotic effect.

Joseph Belanoff: Planned enrollment is 140 patients at sites in the United States and Europe. Many of the investigators who are participating in GRACE will also participate in GRADIENT. You can find our poster presentation of GRADIENT's design at the Research and Pipeline/Publications tab of our website. Our oncology program originated in theories postulated by investigators at the University of Chicago more than 10 years ago. It now consists of 4 clinical trials, 2 of which will produce data in H1 of next year. Our program is examining each of the 3 mechanisms by which cortisol modulation may help treat patients with solid tumors. Cortisol suppresses apoptosis, the programmed cell death chemotherapy is intended to induce. There's compelling preclinical and clinical data suggesting that Relacorilant can help chemotherapy reach its full potential by blunting cortisol's anti-apoptotic effect.

Many of the investigators participating Grace will also participate embraced I know from your presentation gradient inside researching pipeline slide it's just our best.

Joseph K. Belanoff: [inaudible] Unknown Speaker 0, So, genes does not cause off-target effects, including termination of pregnancy, condition of fipionate, natural immunity, and caused by the activity of bacteria. A different mechanism, Relforla, also does not appear to cause hypokalemia, lumbar palsy, and serious side effects experienced by 44% of patients according to the middle tribe. Hormone-induced hyperplasia is a leading cause of

Well I'd tell you program originated in theory cultivated by investigators at the University of Chicago more than 10 years ago.

Now consistent with the trials two of which will produce data from the first half of next year.

The program is examining each of the <unk> that gives us that cortisol modulation may help treat patients with solid tumors.

Joseph K. Belanoff: From phase 1 onwards, clinical data was clearly positive. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs. There were no renal coagulant-induced instances of endometrial thickening, vaginal bleeding, and also no drug-induced hypokalemia.

Well first of all suppresses de Pops is programmed cell death chemotherapy tend to choose.

It was compelling preclinical data.

Suggesting that Relamorelin and hope you know therapy would reach its full potential I've loved being core itself and then Todd.

We are testing this hypothesis in patients with metastatic ovarian cancer metastatic pancreatic cancer.

Joseph K. Belanoff: We are testing this hypothesis in patients with metastatic ovarian cancer and metastatic pancreatic cancer. We initiated these trials following encouraging results in our phase 1/2 trial of Relacorilant combined with nab-paclitaxel, Celgene's drug Abraxane. Tumors in seven of 25 patients with metastatic pancreatic cancer and in five of 11 patients with platinum-resistant ovarian cancer either shrank or stopped growing for 16 weeks or longer. Two patients with metastatic pancreatic cancer exhibited tumor shrinkage for 65 weeks. All patients had experienced disease progression during multiple prior lines of chemotherapy, including treatment with taxane. We presented these results at ASCO in 2019. You can find our poster at the Research and Pipeline/Publication page of our website. In August, we began enrolling patients in RELIANT, an 80-patient open-label phase 3 trial of Relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer.

Joseph Belanoff: We are testing this hypothesis in patients with metastatic ovarian cancer and metastatic pancreatic cancer. We initiated these trials following encouraging results in our phase 1/2 trial of Relacorilant combined with nab-paclitaxel, Celgene's drug Abraxane. Tumors in seven of 25 patients with metastatic pancreatic cancer and in five of 11 patients with platinum-resistant ovarian cancer either shrank or stopped growing for 16 weeks or longer. Two patients with metastatic pancreatic cancer exhibited tumor shrinkage for 65 weeks. All patients had experienced disease progression during multiple prior lines of chemotherapy, including treatment with taxane. We presented these results at ASCO in 2019. You can find our poster at the Research and Pipeline/Publication page of our website. In August, we began enrolling patients in RELIANT, an 80-patient open-label phase 3 trial of Relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer.

The initiating these trials following encouraging results they've won slashing trial.

Joseph K. Belanoff: A poster presenting these results can be found on the investors slash past events tab of our website. We expect Relic Oralyn's Phase 3 RAGE trial, certainly the basis for our NDA submission, to increase the number of patients. Raiz continues to involve patients with any genealogy appreciation.

By that [laughter].

Celgenes drug Abraxane tumors.

Good morning, 725 agents metastatic pancreatic cancer and by the agency.

Just a theory cancer schrager stockbroker 16 weeks longer.

Joseph K. Belanoff: Although, as we have stated before, the pandemic has slowed the trend. We expect to see you at our NDA in the second quarter. Last quarter, we judged the first patient in Rella, Portland, the second base of the trial. Unknown Speaker.

[music] basis, that's static pancreatic cancer exhibited tumor shrinkage for 65 weeks.

Oh patients experienced disease progression during multiple prior lines of chemotherapy, including <unk> assay.

Joseph K. Belanoff: Radiant is specifically studying Relaforla's effects in patients whose Cushion Syndrome is caused by Adrenal Adenoma or Adrenal Hyperplasia. Patients with this etiology of Pritchett syndrome often experience a less rapid decline, but ultimately, their health outcomes are poor.

He presented these results at school 29 team you can find out those your research and pipelines like allocation page progress.

In August we began enrolling patients in reliance agent label Athree trial really well it lets not have access to patients with metastatic pancreatic cancer.

Joseph K. Belanoff: Waiting for the results of the first controlled study, the patients with psychopressure... The expected findings will contribute to optimal treatment. Participants in gradients will receive either Reliquor lens or placebo for 22 weeks. The primary endpoints are statistically significant improvements in hypertension or glucose levels. All of the other common manifestations of Christian syndrome will also be... Planned Enrollment is 140 patients assigned to the United States per year. Many of the investigators who are participating in GREASE will also participate in GREASE. You can find our poster presentation, Gradient Design, at the Research and Pipeline slash Publications tab on our website.

It's supposed to look like let's now [laughter] upright.

Joseph K. Belanoff: Each patient will receive Relacorilant plus nab-paclitaxel. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival, and duration of response. We expect to conduct an analysis of results in RELIANT first 40 patients in H1 2021. The expected response rate to nab-paclitaxel monotherapy in patients with metastatic pancreatic cancer is 0. We believe sufficiently positive results in RELIANT would support accelerated approval. In July, we completed enrollment in our controlled Phase 2 trial in patients with advanced ovarian cancer. 178 patients were randomized to receive nab-paclitaxel and either continuous dosing of Relacorilant, intermittent dosing of Relacorilant, or a placebo. The primary endpoint is progression-free survival, with secondary endpoints including objective response rate, and duration of response. We expect results from this study in H1 next year.

Joseph Belanoff: Each patient will receive Relacorilant plus nab-paclitaxel. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival, and duration of response. We expect to conduct an analysis of results in RELIANT first 40 patients in H1 2021. The expected response rate to nab-paclitaxel monotherapy in patients with metastatic pancreatic cancer is 0. We believe sufficiently positive results in RELIANT would support accelerated approval. In July, we completed enrollment in our controlled Phase 2 trial in patients with advanced ovarian cancer. 178 patients were randomized to receive nab-paclitaxel and either continuous dosing of Relacorilant, intermittent dosing of Relacorilant, or a placebo. The primary endpoint is progression-free survival, with secondary endpoints including objective response rate, and duration of response. We expect results from this study in H1 next year.

The primary endpoint is objective response rate with secondary endpoints.

Free survival duration of response.

Especially conducted in Dallas as a result their lives first way basis in the first half.

[music].

Instead, good response rates and not at the top so loud there.

Patients with metastatic pancreatic cancer.

Correct, yes.

We believe sufficiently positive results like this what sellers are approved.

In July we completed enrollment in our controlled phase two trial.

Yes, yes.

Yes.

78 patients were randomized to receive Nab paclitaxel and either continuous dosing relamorelin intermittent dosing of real world or placebo.

Joseph K. Belanoff: Our ontology program originated in theories postulated by investigators at the University of Chicago more than 10 years ago. It now consists of four clinical trials, two of which will produce data for the first half of the year. Our program is examining each of the three mechanisms by which cortisol modulation may help treat patients with loneliness. For example, cortisol suppresses apoptosis.

Primary endpoints progression free survival and secondary endpoints, including the objective response rate duration of response, we expect results from this study in the first half of next year.

Well, that's all I have to be used to reduce this information.

Joseph K. Belanoff: Cortisol activation produces inflammation and suppresses the immune system, which is why synthetic cortisols are used to treat autoimmune and inflammatory disorders such as rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis. Unfortunately, by suppressing the immune system, cortisol also diminishes the effectiveness of immunotherapy in treating patients with solid tumors. In September, we initiated an open-label phase 1b trial of Relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab, 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's syndrome, a very bad combination. We believe that cortisol excess may also interact and counteract the intended effect of pembrolizumab, which is rarely effective as monotherapy in these patients.

Joseph Belanoff: Cortisol activation produces inflammation and suppresses the immune system, which is why synthetic cortisols are used to treat autoimmune and inflammatory disorders such as rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis. Unfortunately, by suppressing the immune system, cortisol also diminishes the effectiveness of immunotherapy in treating patients with solid tumors. In September, we initiated an open-label phase 1b trial of Relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab, 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's syndrome, a very bad combination. We believe that cortisol excess may also interact and counteract the intended effect of pembrolizumab, which is rarely effective as monotherapy in these patients.

Just the immune system, which is licensed beds cortisols are used to treat autoimmune and inflammatory disorders, such as voice world right I agree.

In Dallas.

Joseph K. Belanoff: Programs for Young Deaf, Keynote Therapy, and the Q&A. There is compelling pre-clinical and clinical data suggesting that running Horlin can help chemotherapy reach its full potential by blunting cortisol and the apoptotic effect. We are testing this hypothesis in patients with metastatic ovarian cancer and metastatic pancreatic cancer. We initiated these trials following encouraging results in our Phase 1-2 trial of Reliquorolans combined with NAP-Hapapaxil, a cell-changing drug, Abraxas, tumors in 725 patients with metastatic pancreatic cancer and 5 of 11 patients with platelet-resistant ovarian cancer who drank or stopped rolling for Two patients with metastatic pancreatic cancer exhibited human strength for 65 weeks.

<unk>.

Unfortunately, I suppressing the immune system. What was also diminishes the effectiveness of the need of therapy in treating patients with solid tumors.

The Tempur, we initiated an open label phase one b trial.

Well, that's the PD one checkpoint it really works.

Works for Keytruda in patients with advanced renal cancer, whose tumors produce excess cortisol.

These patients suffer if that's adrenal cancer and things.

Very bad competition.

Well, it's all excess made also good for that.

Counteract.

We did that.

Which is rarely the fact that there's not a therapy these patients.

Hi trials evaluating whether it really all it can treat these patients <unk> syndrome by reducing the effects of excess or it's all entities as I reversing course, all of these immune suppressive also allow analysts.

Joseph K. Belanoff: Our trial is evaluating whether relacorilant can treat these patients' Cushing's syndrome by reducing the effects of excess cortisol activity and by reversing cortisol-induced immune suppression, allowing pembrolizumab to achieve its full cancer-killing effect. Our posters at this year's ASCO and AACR meetings present preclinical and clinical biomarker data supporting our hypothesis. You can review them at Research and Pipeline/Publications tab of our website. We plan to enroll 20 patients in this trial at 5 sites in the United States. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival, and duration of response. Investigators at the University of Chicago have shown that cortisol stimulates tumor growth in patients with castration-resistant prostate cancer. That finding was confirmed by researchers at Memorial Sloan Kettering Cancer Center. This work explains why patients treated with a widely prescribed androgen receptor antagonist, enzalutamide, eventually experience renewed tumor growth.

Joseph Belanoff: Our trial is evaluating whether relacorilant can treat these patients' Cushing's syndrome by reducing the effects of excess cortisol activity and by reversing cortisol-induced immune suppression, allowing pembrolizumab to achieve its full cancer-killing effect. Our posters at this year's ASCO and AACR meetings present preclinical and clinical biomarker data supporting our hypothesis. You can review them at Research and Pipeline/Publications tab of our website. We plan to enroll 20 patients in this trial at 5 sites in the United States. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival, and duration of response. Investigators at the University of Chicago have shown that cortisol stimulates tumor growth in patients with castration-resistant prostate cancer.

To achieve its full cancer, killing effect.

I was curious if this years, how silly HCR meetings present, preclinical and clinical biomarker data supporting our hypothesis you guys do that right.

Joseph K. Belanoff: All patients had experienced disease progression during multiple prior lines of chemotherapy, including treatment with taps. We presented these results at AbSchool in 2019, and you can find our poster on the research and pipeline slash publication page on our website. In August, we began enrolling patients in Reliance to aid patients who were labeled phase 3 trial Borrelia Borrelia, plus now Pacopaxil, in patients with metastatic pancreatic cancer. Each patient will receive an L.A.C.C.O.R. line plus an outpack of taxidermy.

Research and I blindside other pages of our website.

We plan to roll plate patients in this trial five sites in the United States. The primary endpoint is objective response rate secondary endpoints, including progression free survival duration of response.

Investigators at the University of Chicago, and showing a cortisol stimulates tumor growth in patients with castration resistant prostate cancer.

Joseph Belanoff: That finding was confirmed by researchers at Memorial Sloan Kettering Cancer Center. This work explains why patients treated with a widely prescribed androgen receptor antagonist, enzalutamide, eventually experience renewed tumor growth. Deprived of androgen stimulation, the tumors often utilize cortisol as a growth pathway. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. We are conducting a phase 1b trial of our selective cortisol modulator, relacorilant, combined with enzalutamide in patients with castration-resistant prostate cancer and expect to identify the dose regimen suitable for advancing to a larger controlled study in Q1 2021. I will conclude with an update of our program in metabolic diseases.

Or by researchers loyal Sloan Kettering Cancer Center.

It's Warren explains why agent widely prescribed androgen receptor antagonist immediate upside eventually experience when they need it.

Joseph K. Belanoff: Primary Endpoints, Objective Response Rate, and Secondary Endpoints, including Progression-Free Survival and Duration of Response. We expect to conduct an analysis of results in Reliance's first week, in the first half. Inspected Response Rates of NAP Aquataxel Monogar in patients with metastatic pancreatic Unknown Speaker, We believe sufficiently positive results can rely on the support of Accelerator. In July, we completed enrollment in our controlled Phase 2 trial. 178 patients were randomized to receive NAPAC or Paxil and either continuous dosing of Relaquarolines, intermittent dosing of Relaquarolines, or placebo. The primary endpoint is progression-free survival, with secondary endpoints including objective response rate and duration of response. We expect results from each study in the first half. Cortisol activation reduces inflammation and suppresses the immune system, which is why synthetic cortisol is used to treat autoimmune and inflammatory disorders such as rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis.

The price.

Joseph K. Belanoff: Deprived of androgen stimulation, the tumors often utilize cortisol as a growth pathway. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. We are conducting a phase 1b trial of our selective cortisol modulator, relacorilant, combined with enzalutamide in patients with castration-resistant prostate cancer and expect to identify the dose regimen suitable for advancing to a larger controlled study in Q1 2021. I will conclude with an update of our program in metabolic diseases. In the United States, 6 million people take antipsychotic medications such as olanzapine, Eli Lilly drug Zyprexa, and risperidone, J&J's Risperdal, to treat illnesses such as schizophrenia, bipolar disorder, and major depression. While these drugs are very effective, they exact a steep price in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances.

Average in stimulation that tumors, often utilize cortisol great pathway.

Hi, this is a pretty good cortisol modulator and deprivation therapy closeness to scale.

We will be the LTV is likely trial, our selective cortisol modulator, korlym Biden and sold it to patients with castration resistant prostate cancer and expect to identify the dose regimen suitable for advance into a larger patrol say first quarter.

I will conclude with an update of our progress.

He says that.

In the United States 6 million people to attend that psychotic medications such as Atlanta.

Joseph Belanoff: In the United States, 6 million people take antipsychotic medications such as olanzapine, Eli Lilly drug Zyprexa, and risperidone, J&J's Risperdal, to treat illnesses such as schizophrenia, bipolar disorder, and major depression. While these drugs are very effective, they exact a steep price in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances. Patients can gain more than 50 pounds, and their life expectancy is decreased on average by 20 years, due in part to excess cardiovascular events such as heart attacks and strokes. We have completed three double-blind, placebo-controlled clinical trials in healthy subjects in which co-administration of a cortisol modulator reduced these dangerous metabolic adverse events. Two of these trials used mifepristone, the active ingredient in Korlym.

Lilly drugs I press up and the Sperry to JJ is <unk> pressprich.

Treat illnesses, such as schizophrenia bipolar disorder and major depression.

Each of US are very adept at the exact ski rights in the form of rapid and sustained weight gain cardiovascular disease and other.

Service fees.

Since patients can gain with 15 pounds and the life expectancy is decreased by 20 years due in part to access cardiovascular, but as far as past drugs.

Joseph K. Belanoff: Patients can gain more than 50 pounds, and their life expectancy is decreased on average by 20 years, due in part to excess cardiovascular events such as heart attacks and strokes. We have completed three double-blind, placebo-controlled clinical trials in healthy subjects in which co-administration of a cortisol modulator reduced these dangerous metabolic adverse events. Two of these trials used mifepristone, the active ingredient in Korlym. Our positive results were published in the journal Advances in Therapy and Obesity in 2009 and 2010. Unfortunately, Korlym, which shares an active ingredient with the abortion pill, cannot be advanced for such a prevalent disorder. Miricorilant, by contrast, is not the abortion pill and can be advanced for this use.

Joseph K. Belanoff: Unfortunately, by suppressing the immune system, cortisol also diminishes the effectiveness of immunotherapy to treat patients with solid tumors. In September, we initiated a global labeled Phase 1b trial of relucorolin plus the PD-1 checkpoint inhibitor hemolympham, Lorxtra, and Keytruda in patients with advanced adrenal cancer whose tumors produce excess cortisone. These patients suffered the effects of adrenal cancer 10,000 times over the course of their life. [inaudible] We believe that foods in excess may also interact. Unknown Speaker, Unknown Attendee, Swayampakula Ramakanth, Gary Robb, Joseph Belanoff, Gregory, Our trial is evaluating whether RiloxMorlaine can treat these patients, by reducing the effects of excess cortisol activity and by reversing cortisol-induced immune suppression also allowing hyperlipidemia smap to achieve its full cancer-killing effect. Our posters at this year' You can review them at the Research and Pipeline slash Publications tab of our website.

Yeah completed.

Glad to see the control.

Myles in healthy subjects in the cold Ministration, cortisol modulator, which is dangerous metabolic adverse effects.

Two of these trials use different Bristow you have to in the call.

Results were published in the journal that's there they tend to be into 2009 2010.

Joseph Belanoff: Our positive results were published in the journal Advances in Therapy and Obesity in 2009 and 2010. Unfortunately, Korlym, which shares an active ingredient with the abortion pill, cannot be advanced for such a prevalent disorder. Miricorilant, by contrast, is not the abortion pill and can be advanced for this use.

Unfortunately core Jared I believe we will wash itself and not be if they had specific prevalent disorder.

Yeah, well I.

Perhaps just love to get worse.

It can be a passport issues.

Last quarter, we completed the trial, which healthy subjects receive philanthropy and he was 600 milligrams of New York wireless.

Joseph K. Belanoff: Last quarter, we completed a trial in which healthy subjects received olanzapine and either 600 milligrams of miricorilant, 900 milligrams of miricorilant, or placebo for 14 days. Study participants who received miricorilant gained significantly less weight than those who received placebo. In addition, they exhibited a smaller increase in triglycerides, and the liver enzymes AST and ALT, markers of liver damage that rise with the onset of olanzapine therapy. We plan to publish the full results of this study next year. We are currently conducting two double-blind, placebo-controlled Phase 2 trials of miricorilant in patients with schizophrenia. The first, GRATITUDE, is evaluating whether miricorilant can reverse recent antipsychotic-induced weight gain. 100 patients will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of miricorilant or placebo for 12 weeks. GRATITUDE is being conducted at approximately 20 centers across the United States.

Joseph Belanoff: Last quarter, we completed a trial in which healthy subjects received olanzapine and either 600 milligrams of miricorilant, 900 milligrams of miricorilant, or placebo for 14 days. Study participants who received miricorilant gained significantly less weight than those who received placebo. In addition, they exhibited a smaller increase in triglycerides, and the liver enzymes AST and ALT, markers of liver damage that rise with the onset of olanzapine therapy. We plan to publish the full results of this study next year. We are currently conducting two double-blind, placebo-controlled Phase 2 trials of miricorilant in patients with schizophrenia. The first, GRATITUDE, is evaluating whether miricorilant can reverse recent antipsychotic-induced weight gain. 100 patients will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of miricorilant or placebo for 12 weeks. GRATITUDE is being conducted at approximately 20 centers across the United States.

No as well.

14 days.

Our dispensers generic world it seems significantly less weight and as Wishy washy, though.

In addition, they exhibited a smaller increase in triglycerides and the liver enzymes GST unhealthy markers of liver damage that guidance so less errors.

We've got plans to publish the older Adult study next year.

We are currently conducting two double blind placebo controlled phase two trials in Europe, where I went to patients. This just right.

The first right.

He is evaluating whether in Europe or in reverse recent site psychotic do speech.

Joseph K. Belanoff: We plan to enroll 20 patients in this trial at five sites in the United States. The primary endpoint is objective response rate, with secondary endpoints including depression-free survival and duration. Investigators at the University of Chicago have shown that cortisol stimulates tumor growth in patients with castration-resistant prostate cancer.

Another thing that's where we see if you consider established as a psychotic medication is 600 milligrams of New York wallet.

Ladies.

She was being conducted at approximately 20 centers across the United States.

During the third quarter, we initiate gratitude to.

Joseph K. Belanoff: During Q3, we initiated GRATITUDE II, a randomized double-blind, placebo-controlled Phase 2 trial of miricorilant to treat long-standing antipsychotic-induced weight gain. 150 patients with schizophrenia will continue to receive their established dose of antipsychotic medication plus either 600 milligrams or 900 milligrams of miricorilant or placebo for 26 weeks. The primary endpoint is reduction in body weight. GRATITUDE II will be conducted at 35 centers in the United States. In animal models, miricorilant also prevents and reverses fatty liver and liver fibrosis, precursors of non-alcoholic steatohepatitis, or NASH, a serious liver disorder that affects millions of patients. Later this month, we plan to start a 120-patient double-blind, placebo-controlled Phase 2 trial of miricorilant to patients with NASH. Corcept's Q3 results were blunted because of pandemic-related public health measures and related changes in physician and patient behavior.

Joseph Belanoff: During Q3, we initiated GRATITUDE II, a randomized double-blind, placebo-controlled Phase 2 trial of miricorilant to treat long-standing antipsychotic-induced weight gain. 150 patients with schizophrenia will continue to receive their established dose of antipsychotic medication plus either 600 milligrams or 900 milligrams of miricorilant or placebo for 26 weeks. The primary endpoint is reduction in body weight. GRATITUDE II will be conducted at 35 centers in the United States. In animal models, miricorilant also prevents and reverses fatty liver and liver fibrosis, precursors of non-alcoholic steatohepatitis, or NASH, a serious liver disorder that affects millions of patients. Later this month, we plan to start a 120-patient double-blind, placebo-controlled Phase 2 trial of miricorilant to patients with NASH. Corcept's Q3 results were blunted because of pandemic-related public health measures and related changes in physician and patient behavior.

Joseph K. Belanoff: Finally, confirmed by researchers at Memorial Sloan Kettering Cancer Center, this org explains why patients treated with a widely prescribed antigen receptor antagonist can be immunized, eventually experiencing relief during birth. The pride of androgen stimulation is that tumors often utilize cortisol as a great pathway.

A randomized double blind placebo controlled phase two trial, we are willing to trade laws now did you have anything to do so.

Well.

It is and schizophrenia or continue to receive their established as I say I think it well.

Yes. It is 600 milligrams or 900 Villa is Europe wireless like this even though for 26 weeks.

Joseph K. Belanoff: Our hypothesis is that adding a cortisone modulator to endocrine deprimation therapy will close this tumor escape. We are conducting a phase 1 trial of our selected cortisol modulator, hexachloroate, combined with antalutamide, in patients with castration-resistant prostate cancer. I expect to identify a dose regimen suitable for advancing to a longer-controlled study in the first quarter. I will conclude with an update on our programming deadlines. In the United States, 6 million people take anti-psychotic medications such as Lanzapine, the E-liability drug Iprexa, and Risperidone, J&J's Risperidone.

The primary endpoint is reduction in body.

Right and you too will be constructed at 35 centers in the United States.

No miles near a floral it also permits and reverse its valuable work and liver fibrosis precursors non alcoholic Seattle, hepatitis or Nash serious liver disorder that affects millions of patients.

Later this month, we plan to start.

20 patient double blind placebo controlled phase two trial of the old world to patients.

[music].

Well that's notable results, let me caution as it relates to public health measures and related changes in physician and patient behavior.

He said our commercial business is remarkably stable and its place to resume its growth what's the pad to exercise. These steps this year with the efforts of our regional pretty bad debt revenue guidance, which we now like to arrange a 355.

Joseph K. Belanoff: That being said, our commercial business is remarkably stable and is poised to resume its growth once the pandemic subsides. We expect to finish the year within the bounds of our original pre-pandemic revenue guidance, which we narrow to a range of $355 to 365 million. Our cash and investments grew by $34.7 million to $442.2 million. We announced a program to repurchase up to $200 million of our common stock. Our clinical program continues to broaden and will produce significant data in 2021 and 2022. Enrollment is underway in two phase 3 trials of relacorilant, our planned successor in Cushing's syndrome. We expect the GRACE trial to provide the basis for our NDA submission in Q2 2022.

Joseph Belanoff: That being said, our commercial business is remarkably stable and is poised to resume its growth once the pandemic subsides. We expect to finish the year within the bounds of our original pre-pandemic revenue guidance, which we narrow to a range of $355 to 365 million. Our cash and investments grew by $34.7 million to $442.2 million. We announced a program to repurchase up to $200 million of our common stock. Our clinical program continues to broaden and will produce significant data in 2021 and 2022. Enrollment is underway in two phase 3 trials of relacorilant, our planned successor in Cushing's syndrome. We expect the GRACE trial to provide the basis for our NDA submission in Q2 2022.

Joseph K. Belanoff: Treating illnesses such as schizophrenia, bipolar disorder, and major depression. Well, these drugs are very effective. They attack steep hills in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances.

Collars.

Our cash and investments.

Very important when $7 to $142.2 million.

Joseph K. Belanoff: Patients can gain up to 50 pounds, and their life expectancy is decreased on average by 20 years, due in part to excess cardiovascular events such as heart attacks and stroke. We have completed 3 double-blind placebo-controlled clinical trials in healthy subjects in which co-administration of a cortisol modulator reduces dangerous metabolic adversities. Two of these trials used nickel-fristone, the active ingredient in coelacanth.

That's the program to repurchase up to $200 million stock.

Stock.

Okay, I think Houston.

It will produce.

2021 2022.

Well, it's underway two phase three trials abril wireless plans et cetera and things.

We expect the greatest trial to provide the basis for our education initiatives second quarter Twentytwenty two.

Our second trial Reagan's, it's evaluating relamorelin in patients with Cushing syndrome to treat a large here.

Joseph K. Belanoff: Our second trial, GRADIENT, is evaluating relacorilant in patients with Cushing's syndrome of adrenal origin. We are confident it will help physicians better understand and treat this less studied etiology of the disease. Data from the first 40 patients in our Phase 3 RELIANT trial of relacorilant with nab-paclitaxel in patients with metastatic pancreatic cancer will be available in H1 next year. Sufficiently positive results from RELIANT will likely qualify relacorilant for accelerated approval. Our controlled Phase 2 trial of relacorilant with nab-paclitaxel in patients with metastatic ovarian cancer will also produce results in H1 2021. Last month, we initiated a 20-patient label Phase 1B trial of relacorilant combined with the PD-1 checkpoint inhibitor, pembrolizumab, to treat patients with advanced adrenal cancer and cortisol excess.

Joseph Belanoff: Our second trial, GRADIENT, is evaluating relacorilant in patients with Cushing's syndrome of adrenal origin. We are confident it will help physicians better understand and treat this less studied etiology of the disease. Data from the first 40 patients in our Phase 3 RELIANT trial of relacorilant with nab-paclitaxel in patients with metastatic pancreatic cancer will be available in H1 next year. Sufficiently positive results from RELIANT will likely qualify relacorilant for accelerated approval. Our controlled Phase 2 trial of relacorilant with nab-paclitaxel in patients with metastatic ovarian cancer will also produce results in H1 2021. Last month, we initiated a 20-patient label Phase 1B trial of relacorilant combined with the PD-1 checkpoint inhibitor, pembrolizumab, to treat patients with advanced adrenal cancer and cortisol excess.

We are confident will help physicians better understand that treats let's say geology.

Yeah, I don't know the first 40 patients to our base to rely on trial will correlate a snap paclitaxel in patients that have got against her will be available in the first half of next year.

Joseph K. Belanoff: Our positive results were published in the journals Advanced Therapy and Obesity in 2009 and 2010. Unfortunately, Corla, who shares an active engagement with the abortion pill, cannot be advanced for such a prevalent disorder. Mirror Coraline, by contrast, does not do abortion and can be enhanced for this. Last quarter, we concluded a trial in which healthy subjects received philanthropine and either 600mg of miracorlin, 900mg of miracorlin, or placebo for 14 days. Many participants who received mirocoagulant gained significantly less weight than those who received placebo. In addition, they exhibited a smaller increase in triglycerides and the liver enzymes AST and ALT, markers of liver damage that may lead to the onset of a lacerative error.

Traditionally positive results for a little while reliance will likely fall five relic world for accelerated approval.

Our controlled phase two trial with all growing but actual patients has varying cancer all of these results the first half.

Yes.

Last month, we initiated a 20 page in open label Phase, one B trial relic Raleigh.

PD, one checkpoint inhibitor and Realising that you treat patients with advanced renal cancer headquarters all excess.

Finally in the first quarter. This year, we expect to select the optimum does it actually correlate to dance.

Joseph K. Belanoff: Finally, in Q1 of next year, we expect to select the optimum dose of relacorilant to advance in combination with enzalutamide in a controlled phase 2 trial of patients with castration-resistant prostate cancer. Our program in metabolic diseases also made significant gains. Enrollment and site activation continue in GRATITUDE, our double-blind, placebo-controlled phase 2 trial of miricorilant to reduce recent antipsychotic-induced weight gain. We have begun enrollment in GRATITUDE II, a double-blind, placebo-controlled phase 2 trial of miricorilant in patients with long-standing antipsychotic-induced weight gain. We expect to start a double-blind, placebo-controlled phase 2 trial of miricorilant in patients with NASH later this month. I'll stop here for questions.

Joseph Belanoff: Finally, in Q1 of next year, we expect to select the optimum dose of relacorilant to advance in combination with enzalutamide in a controlled phase 2 trial of patients with castration-resistant prostate cancer. Our program in metabolic diseases also made significant gains. Enrollment and site activation continue in GRATITUDE, our double-blind, placebo-controlled phase 2 trial of miricorilant to reduce recent antipsychotic-induced weight gain. We have begun enrollment in GRATITUDE II, a double-blind, placebo-controlled phase 2 trial of miricorilant in patients with long-standing antipsychotic-induced weight gain. We expect to start a double-blind, placebo-controlled phase 2 trial of miricorilant in patients with NASH later this month. I'll stop here for questions.

It was really the light control they have issues to trial pitches and castration resistant prostate cancer.

Oh really metabolic diseases alternatives, yes.

Enrolling site activation continuing gratitude, a double blind placebo controlled phase two trial in Europe really to reduce recent capex I got confused.

Joseph K. Belanoff: We don't plan to publish the full results of this study. We are currently conducting two double-blind placebo-controlled Phase II trials here in Portland. [inaudible] is evaluating whether mirrored morality can reverse reasons and psychotics. 100 patients will receive, in addition to their established visits and their psychotic medication, 600 milligrams of NeuroCoronavir as placebo for 12 weeks. Ratitude is being conducted at approximately 20 centers across the United States. During the third quarter, we initiated RATITUDE 2, a randomized, double-blind, placebo-controlled, phase 2 trial of miracoral infections in addition to long-standing antipsychotics. 150 patients with schizophrenia will continue to receive their established dose of antipsychotic medication.

Hey, Buddy it'd be delayed enrollment in gratitude to double blind placebo controlled phase two trial in Europe, or Asia, longstanding I say high teens.

We expect to start a double blind placebo controlled phase two trial near Orla in patients with Nash later this month.

I'll stop here for questions.

Thank you if you would like to ask a question. Please press star one on your telephone keypad, if you're on speaker phone. Please make sure that your mute function is turned off to allow your signal to reach our equipment again that is star one for questions well pause just a moment so that everyone has an opportunity to signal for questions.

Operator 3: Thank you. If you would like to ask a question, please press star one on your telephone keypad. If you're on speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment. Again, that is star one for questions. We'll pause just a moment so that everyone has an opportunity to signal for questions. We will go to our first question from Tazeen Ahmad of Bank of America. At this time, our first question will come from Tazeen Ahmad of Bank of America.

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. If you're on speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment. Again, that is star one for questions. We'll pause just a moment so that everyone has an opportunity to signal for questions. We will go to our first question from Tazeen Ahmad of Bank of America. At this time, our first question will come from Tazeen Ahmad of Bank of America.

And we will go to our first question from at.

At this time.

My first question will come from.

Having a much of bank of America.

Hi, good afternoon, Thanks for taking my question.

Joseph K. Belanoff: Hi. Good afternoon. Thanks for taking my questions. A couple from me. I guess so if you guys end up winning the PGR and let's say also the district court case, and you do, in that event, have no competition for Korlym for several years.

Joseph Belanoff: Hi. Good afternoon. Thanks for taking my questions. A couple from me. I guess so if you guys end up winning the PGR and let's say also the district court case, and you do, in that event, have no competition for Korlym for several years.

[laughter] pardon me so I guess so after you guys ended up winning the PPR and lets say also that district Court case, and you do and out of that have no competition for korlym for several years.

Joseph K. Belanoff: Plus, either 600 milliamps or 900 milliamps of Neuracorreline. The primary endpoint is reduction in volume. Ratatouille 2 will be conducted at 35 centers in New York. In animal models, mirocoagulant also prevents and reverses fatty liver and liver fibrosis, which are precursors of non-alcoholic steatohepatitis, or NAHD.

And you also plan on launching Relamorelin in Cushing.

Tazeen Ahmad: You also plan on launching Relacorilant in Cushing's. How do you think that both of those drugs could coexist? Is there a subset of the population that might be better served with one drug over the other? Or is it your view that over time, sales for Korlym would fade as there's more pickup for Relacorilant?

How do you think that both of those jobs could kinda like that is there a subset of the population that might be better served with one drug over the other or is it your view that over time Phelps acquire level, let's say it adds a theres more pickup gorilla Carla.

Joseph K. Belanoff: Serious liver disorder that affects millions of patients. Later this month, we plan to start a 120-patient, double-blind, placebo-controlled phase 2 trial of Miracle-RLM in patients with, Corcepts work more results with once-in-a-few-causes pandemic-related public health measures and related changes in physician and patient care. That being said, our commercial business is remarkably stable and is poised to resume its growth once the pandemic subsides. We expect to finish the year within the bounds of our original pre-pandemic revenue guidance, which we now have to arrange at $355 million. Are Cash and Investments Ruled by 34?

I hate to being a thanks. This is Charlie so I'll answer the first part of the question that you are just talking about the the.

Charlie Robb: Hey, Tazeen. Thanks. This is Charlie. I'll answer the first part of the question, and then maybe I'll just talk about the relative use to grow. I just want to say if we win the district court case, it's true, we'll have a patent that has protected Korlym and would protect Korlym through 2037. It's seventeen years of additional protection. It'd be quite a long time, which makes your question a very pertinent one. I just want to make it clear to folks that if we have that kind of legal success you described, that is the one we would have with Korlym after that.

The mill to you too.

But I just want to say if we if we you read the district, it's true of highway Oh.

And then as a.

Why don't we get quality through 23 to seven so yes, it's 70 years this year.

Protection, so quite a long time to meet your pressure, but a little bit, but just wondering your thoughts there.

You have that kind of what kind of lead. The success you cite that is why we have formed after that but it's still good loan growth going forward, because we want to sure Charlie Thanks for the questions and see how it just to be completely straight forward guidance, you see I think that relative to what is a.

Joseph K. Belanoff: The Bulletproof Executive 2013, We announced a program to re-purchase up to $200 million of our common stock. Our clinical program continues to thrive and will produce significant data in 2021-2022. The role is underway in two Phase III trials for alcoholics, our plant successors, and cushions. We expect the GRACE trial to provide the basis for our NDA submissions in the second quarter. Our second trial, Gradient, is evaluating relative correlations with Cushing's syndrome of adrenal heart.

Joseph K. Belanoff: As to the role of Relacorilant and Korlym, Joe, you wanna address that? Sure, Charlie. Thanks for the question, Tazeen. Just to be completely straightforward about it, Tazeen, I think that Relacorilant is a clearly superior medication to Korlym if it pans out the way it has so far. I think removing its progesterone-related side effects and now as we find out, drug-induced type of mania, it's my expectation that over time, Relacorilant will entirely replace Korlym as the first choice drug.

Joseph Belanoff: Sure, Charlie. Thanks for the question, Tazeen. Just to be completely straightforward about it, Tazeen, I think that Relacorilant is a clearly superior medication to Korlym if it pans out the way it has so far. I think removing its progesterone-related side effects and now as we find out, drug-induced type of mania, it's my expectation that over time, Relacorilant will entirely replace Korlym as the first choice drug.

At least superior medication or is it pans out of the way. It has so far things are moving is a professor and related side effects to know lined out ability. These type of media, it's my expectation that over time.

Well the entirely replace flow as Gordon choice trough.

Okay, and do you think that would happen immediately or would that be.

Tazeen Ahmad: Okay. Do you think that would happen immediately or would that be more of a, you know, a gradual switchover?

More of a you know Brad.

Joseph K. Belanoff: We are confident we'll help physicians better understand and treat this life-saving genealogy. Data from the first 40 patients in our phase 2 Reliant Trial for L-ChloroLift or SNAP Aquanax in patients with MEDSAG pancreatic cancer will be available in the first half of December. Traditionally positive results from a reliant but likely qualified relic for accelerated improvement. Our controlled Phase 2 trial, Relagorilin plus Napaxil, patients with metastatic ovarian cancer, all of it. Last month, we initiated a 20-page improvement label, a Phase 1b trial, a relic roll-in designed with a PD-1 checkpoint inhibitor and realism mask to treat patients with advanced adrenal cancer and cortisol patients. Finally, in the first quarter of next year, we expect to select the often-invasive hexachlorolytes to advance in combination with indolizumide in controlled Phase II trials for patients with castration-resistant prostate cancer.

Perhaps a while whatsoever.

Yeah, it's a little hard to say, yes.

Joseph K. Belanoff: Yeah, it's a little hard to say, you know, at this point, but my expectation is that it would be sooner rather than later.

Joseph Belanoff: Yeah, it's a little hard to say, you know, at this point, but my expectation is that it would be sooner rather than later.

So my expectation is that even sooner rather than later.

Okay. Thank you and then maybe one question if I may on on a pipeline program for Nash.

Tazeen Ahmad: Okay. Thank you. Maybe one question, if I may, on a pipeline program for NASH. It seems that there are many mechanisms of action that are being explored by many different companies. I was curious, it's very early, but how do you think your particular approach could be differentiated either in terms of efficacy and/or safety, in that population? Thanks.

But there are many mechanisms of action that being explored by many different companies and and I was curious it's very early but how do you think is more your particular approach could be differentiated either in terms of assets. He and are taking part in that population. Thanks.

Yeah, I'd like to just because I I was here.

Joseph K. Belanoff: Yeah. I'd like to just, since I have him here, our Chief Medical Officer, Andreas Grauer, and, I think he'll take your question, Tazeen.

Joseph Belanoff: Yeah. I'd like to just, since I have him here, our Chief Medical Officer, Andreas Grauer, and, I think he'll take your question, Tazeen.

Our Chief Medical Officer, Andreas Growler, and Ah I think they'll take your like Jesus.

Yeah.

Good thanks, so much for the question.

Andreas Grauer: Yeah. Again, thanks so much for the question. It's a great one, and we should be at the onset already. We've seen very promising data in this particular disease model and preclinical model. The first thing I wanna say is the mechanism is totally different from how the other drugs that are in development are addressing NASH. Whether it'll be clear in efficacy, I think that we will see in efficacy data. That's why we're doing a proof of concept study now as a first step. The safety profile will obviously also inform the transition. Our hopes are high that this will work great.

Right.

Yeah Yeah.

I see very Boston.

<unk>.

Personally I wouldn't say, it's really different so.

Oh.

Oh, sorry.

I see.

Operator: A program in metabolic disease is also... Enrolling in Trig Activation Continuum Gratitude, a double-blind placebo-controlled Phase 2 trial near a correlate to reduce recent anti-psychotic symptoms. And we have begun enrolling in Gratitude 2, the double-blind, placebo-controlled, phase 2 trial, Miracle-R, for patients with long-stay. We expect to start a double-blind, single-control, phase 2 trial at New York Orlin for patients with NASH later this year. I'll stop here for questions. If you would like to ask a question, please press star 1 on your telephone keypad. And if you're on speakerphone, please make sure that your mute function is turned off to allow your signal to return.

So.

Oh.

See you.

Mm Hmm.

That's why we're.

Concept study power.

Perfect.

And the safety profile.

Yes.

Right.

Okay.

Hi, good morning.

Yeah.

With that it's just I'd just add that you just sort of how we got here.

Joseph K. Belanoff: I'd like to just add to just sort of how we got here. You know, we noticed with patients who were treated with Korlym that in at least one measure, not specifically NASH, but people who had long-standing elevation in liver enzymes due to liver irritation over a period of time, their enzymes often normalized. That's what really started us on the path with Relacorilant to the preclinical testing that Andreas has described. We're really looking forward to see if that translates to human effects. We'll talk to you in the future about it.

Joseph Belanoff: I'd like to just add to just sort of how we got here. You know, we noticed with patients who were treated with Korlym that in at least one measure, not specifically NASH, but people who had long-standing elevation in liver enzymes due to liver irritation over a period of time, their enzymes often normalized. That's what really started us on the path with Relacorilant to the preclinical testing that Andreas has described. We're really looking forward to see if that translates to human effects. We'll talk to you in the future about it.

We mourn his with agency to treat it as a world that is at least one that has not yet done specifically for people who had longstanding elevate.

The European over a period of time and the insight is often more lives and that's it really started to us on a path for drilling to the things that we're testing that Andreas has described we're really looking forward to see if that translates to do and that's so we thought it would be for that.

Okay, Okay, and do you have a sense of when we would be able to see data from that program.

Tazeen Ahmad: I see. Okay. Do you have a sense of when we would be able to see data from that program?

Operator: Again, that is star number one for questions. I'm going to pause just a moment so that everyone has an opportunity to signal for questions. And we will go to our first question from, At this time, our first question will come from Tazeem. Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept, Hi, good afternoon. Thanks for taking my questions. A couple for me.

I'm going to ask for it and I guess, north and we're getting we're just getting started.

Joseph K. Belanoff: The next program, Andreas?

Joseph Belanoff: The next program, Andreas?

Andreas Grauer: Yeah. Well, we're just getting started. We're hoping to start screening, like, imminently, basically. We're hoping to have data in about 18 months.

We're.

Let me start screaming like eminently basically.

And would I be too have data.

Hmm.

Okay, great. Thank you for the question.

Tazeen Ahmad: Okay, great. Thank you for the questions.

And so.

So question from Matt Kaplan of Ladenburg Thalmann.

Operator 3: We'll move next to a question from Matthew Kaplan of Ladenburg Thalmann.

Operator: We'll move next to a question from Matthew Kaplan of Ladenburg Thalmann.

Hi.

Good afternoon, guys and thanks for taking the question I'm just that's the Oh Gee, that's your questions with respect to maybe digging into the impact or the code that they too are for pandemic.

Matthew Kaplan: Hi. Good afternoon, guys, and thanks for taking the questions. Just a few questions with respect to maybe digging into the impact of the COVID-19 pandemic, the progress with the GRACE studies and the GRADIENT, so that's phase 3 study as well. What are you seeing there in terms of challenges?

Matt Kaplan: Hi. Good afternoon, guys, and thanks for taking the questions. Just a few questions with respect to maybe digging into the impact of the COVID-19 pandemic, the progress with the GRACE studies and the GRADIENT, so that's phase 3 study as well. What are you seeing there in terms of challenges?

Swayampakula Ramakanth: So I guess, Joe, if you guys end up winning the PTR, and let's say also the district court case, and you do, in that event, have no competition for Coraline for several years, and you also plan on launching Relacoraline in Cushing's, how do you think that both of those drugs could coexist? Is there a subset of the population that might be better served with one drug over the other? Or is it your view that, over time, sales for Coraline would fade as there's more pickup for Relacoraline? This is Charlie.

The progress with it there.

Great.

Studies and bring it Ah that's a safety study as well.

What are you seeing there in terms of challenges.

No, it's a little bit I was a little bit choppy here. He says well you asking the question in part of our ongoing business, the quell or someplace else.

Joseph K. Belanoff: Matt, it's a little bit choppy to hear you. Are you asking the question in regard to our ongoing business with Korlym or with the GRACE study?

Joseph Belanoff: Matt, it's a little bit choppy to hear you. Are you asking the question in regard to our ongoing business with Korlym or with the GRACE study?

No in terms of the the ongoing Gray study and Radiant studies impact of Oh, well the 19 on on those on those programs.

Matthew Kaplan: No. In terms of the ongoing GRACE study and GRADIENT studies, the impact of COVID-19 on those programs.

Matt Kaplan: No. In terms of the ongoing GRACE study and GRADIENT studies, the impact of COVID-19 on those programs.

Gary Charles Robb: So I'll answer the first part of the question. But I just want to say, if we win the district court case, it's true, we'll have a, you know, a, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Gregory Fraser, Edward Nash, Aaron, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc. [in I think removing its progesterone-related side effects, and now we find out drug-induced hypothermia, it's my expectation that, over time, Relacorlin will entirely replace Corlin as the first drug. Okay, and do you think that would happen immediately? Or would that be more of a, you know, a gradual switch over?

Oh, great HM.

Joseph K. Belanoff: Andreas, please.

Joseph Belanoff: Andreas, please.

Oh boy.

Andreas Grauer: Sure. Well, I mean, the COVID-19 pandemic is tough to deal with for everybody. We are still working on meeting our commitment, which I laid out in his remarks, and are working on filing by the future.

So I think it's tough to dividends for everybody.

We are still working.

Okay.

For a time when the children.

HM.

So in.

His remarks and ER.

Finally, I'm finding future.

Yeah, I would just remind you because they see the lab said at the beginning of the.

Joseph K. Belanoff: You know, I just remind you, just for those of you who haven't, is that at the beginning of the pandemic, and we really began to notice what was in fact going on at that point too, we did extend the timeline to the point where it is right now, but we have not changed it since that point.

Joseph Belanoff: You know, I just remind you, just for those of you who haven't, is that at the beginning of the pandemic, and we really began to notice what was in fact going on at that point too, we did extend the timeline to the point where it is right now, but we have not changed it since that point.

Pandemic and we really didn't know what was going on at that point and extended the timeline to the point, where it is right now, but we have not changed since that point in time.

Okay. That's helpful. Thanks, and then in terms of I guess, maybe a question for Charlie you kind of.

Matthew Kaplan: Okay. That's helpful. Thanks. In terms of, I guess, maybe a question for Charlie, you kind of portrayed kind of a best case scenario of 2037 for if everything goes in your direction with the litigation with Teva and Sun. Can you help bracket that and help us understand in terms of maybe a base case scenario in terms of how things could progress and the other end of that spectrum when you could potentially see a generic competition, the way things are playing out right now?

Matt Kaplan: Okay. That's helpful. Thanks. In terms of, I guess, maybe a question for Charlie, you kind of portrayed kind of a best case scenario of 2037 for if everything goes in your direction with the litigation with Teva and Sun. Can you help bracket that and help us understand in terms of maybe a base case scenario in terms of how things could progress and the other end of that spectrum when you could potentially see a generic competition, the way things are playing out right now?

Portrayed kind of a best case scenario of a 2037 for if everything goes in your direction with the litigation with having Sun can you help bracket that and and help us understand in terms of maybe a base case scenario in terms of how things could congrats on the other end of that that spectrum.

Gary Charles Robb: Yeah, it's a little hard to say, of course, but my expectation is that we'll be sooner rather than later. Okay, thank you. And then, maybe one question, if I may, on a pipeline program for NASH. It seems that there are many mechanisms of action that are being explored by many different companies.

When you could potentially see a generic competition the way things are playing out right now.

Well the 2037 date I mentioned is just the base.

Charlie Robb: Well, the 2037 date I mentioned is just the date of kind of our longest running patent and the one also that's being challenged now, the PGR that we will, as I mentioned, you know, have an important decision about in a couple of weeks in the patent office. That's where the 2037 date runs to. As for you know, sort of bracketing it, I think that's really kind of hard to do. We have a patent, and if we prevail, we have a patent that runs through 2037. There's no bracketing of that. That's just the date. Typically these cases settle if they are going to settle, and you know, probably can be settled sooner.

I kind of our longest running and we went all so that's been a challenge now the PDR that we will.

As I mentioned.

Important decision about in a couple of weeks.

Swayampakula Ramakanth: And I was curious, it's very early, but how do you think your particular approach could be differentiated either in terms of efficacy or safety in that population? Thank you. And I'd like to just, because I have him here, our Chief Medical Officer, Andres Grauer, and I think he'll take your questions. Again, thanks so much for the question. It's a great one, and we wish we had the answer already

So that's that's what important 37 days, a legacy and as for sort.

Sort of bracketing.

Do you have a path.

Yeah, we have 20.

Very excited as rapidly.

Yes, they should be so if they are going to settle.

I mean that soon.

And given that you know the.

Charlie Robb: By giving the generic company some amount of time, you know, earlier than that longest running patent. That's, you know, just sort of the way the averages work. It doesn't necessarily mean the same thing's gonna happen here. We're feeling very good about our case right now. We'll see what happens. Really, the bracket is not really anything I can offer. I just, I do have one end of it, that's 2037, and we'll have to see if there's any other dates there.

The engineering company, some amount of time or was there anything that longest running and the.

Andres Grauer: We've seen very promising data in this particular disease model and this clinical model. The first thing I want to say is the mechanism is totally different from how the other drugs that are in development are. [inaudible] Unknown Speaker, Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William. That's why we're doing a concept study now as a first step.

That's just sort of the day the averages work, but that's certainly seems to me your.

Yeah, if I have it right now wins, but really.

So back it is it's not really that can offer I just I do have one is a bit that's 2037 and we'll have to see if there's any other big.

Okay. Okay. That's helpful. Thanks, and then just in terms of a pipeline question.

Matthew Kaplan: Okay. That's helpful. Thanks. Just in terms of a pipeline question, if I may. The RELIANT Phase 3 study, you mentioned that data from the first half of the study, the first 40 patients, would be available in H1 2021. I guess what should we be looking for in terms of with respect to the primary endpoint objective response rate? Is that the data we're going to see in the first half in the first 40 patients?

Matt Kaplan: Okay. That's helpful. Thanks. Just in terms of a pipeline question, if I may. The RELIANT Phase 3 study, you mentioned that data from the first half of the study, the first 40 patients, would be available in H1 2021. I guess what should we be looking for in terms of with respect to the primary endpoint objective response rate? Is that the data we're going to see in the first half in the first 40 patients?

Swayampakula Ramakanth: And just, I'd like to just add, just sort of how we got here. You know, we noticed with patients who were treated with Corla that in at least one measure, not specifically Nash, but people who had long-spanning elevations a few times due to irritation over a period of time, their enzymes often normalized, and that's what really started us on the path with Neuroenthrolin to the preclinical testing that Andreas We're really looking forward to seeing if that translates to human effects and so forth in the future. Okay, and do you have a sense of when we will be able to see Gada on that program? I'm going to ask you for a brief address.

I find that.

The rely a phase three study you mentioned that data from the first half of the study. The first 40 patients would be available in the first half of 21 I guess what.

What should we be looking for in terms of with respect to the pilot and quiet objective response rate is that is that the data we're going to see a in the first half and the first 40 patients.

Oh, yes.

The interim analysis planning process for its tough.

Andreas Grauer: The interim analysis that we're planning from this H1 will basically give us a first look at the primary endpoint. It's at that point not powered to make any definitive conclusions, but it will give us an indication on where we are and whether we're tracking towards success. It will obviously give us encouragement to continue the trial at a fast pace.

Good luck.

So.

No.

Why that at that point, our power to make it easy.

Andres Grauer: Yeah, we're just getting started. Um, we, we're, um, I'm hoping to start screening imminently, basically, and I'm hoping to have data in about 18 months. Okay, great. Thank you for the question. We will move next to a question from Matt Kaplan of Latin America. Hi, good afternoon, guys.

I mean is that really gauge and on where we are and where you were tracking towards success and then Andrew do you give us any Hollywood.

Isn't there or anything that you can see the trial.

Thanks.

And then just.

Joseph K. Belanoff: Bill, let me just add. I'm sorry. Go ahead, guys, please. I'm back.

HM.

Joseph Belanoff: Bill, let me just add. I'm sorry. Go ahead, guys, please. I'm back.

Sorry go ahead please.

Yeah, just in terms of.

Matthew Kaplan: Yeah. Just in terms of, maybe you can help us understand what objective response rate would be deemed as successful. You know, I guess pancreatic cancer is, you know, obviously a very difficult indication.

Matt Kaplan: Yeah. Just in terms of, maybe you can help us understand what objective response rate would be deemed as successful. You know, I guess pancreatic cancer is, you know, obviously a very difficult indication.

Maybe you can help us understand what objective response rate.

Could be a game dads successful you know I guess pancreatic cancer as you know obviously very difficult indication.

Matthew Lee Kaplan: Thanks for taking the questions. Um, just a few questions with respect to maybe digging into the impact of the COVID-19 pandemic on the progress with the GRACE studies and the Gradient, I guess, GRACE study as well. What are you seeing there in terms of challenges? Matt, it's a little bit choppy to hear you, so were you asking the question in regards to our ongoing business with Coraline, or did you embrace that? No, in terms of the ongoing GRACE study and gradient studies, and the impact of COVID-19 on those on this program. Andreas, please?

HM.

Andreas Grauer: Yeah. To me. Absolutely. I just wanna add a little bit of context, right? This is a trial in patients with third line or more pancreatic cancer. So they're really very, very sick people. Currently the response for most treatments that can be tried in these patients is they zero, you know, nothing works. Any response will probably be an improvement for these patients. The bar for accelerated approval at the FDA is a significant bar. I mean, in their own words, they like to be wowed by the results, and that's obviously somewhat of a subjective statement. I mean, we feel if we had a 20% response rate, everybody would be wowed by that.

Absolutely and then and I just want to add any sort of context right.

Hi Island Nations.

Her life or more.

Great answers.

Great very sick people and currently they response to.

Treatment that can be tried in patients.

Yes.

And so.

So [laughter] any response.

Mm Hmm space.

The market for accelerated approval yesterday.

It's Kevin Farr.

No I'd say, they like to be Bob.

Yes, and that's obviously what are the subject of statement I.

I mean, we feel we had a 20% tariff response rates everybody.

And then it's less than that.

Andreas Grauer: I mean, if it is less than that, but it's sort of better than what current therapies deliver, then we'll have to have a careful look at the data and see what comes out.

That's better.

Andres Grauer: Sure. Well, I mean, the COVID pandemic is tough to deal with for everybody. We are still working on moving our timeline, which was laid out in his remarks, and we are working on filing it by the future. You know, it just reminds me, just for those of you who haven't heard this, that at the beginning of the pandemic, we really began to notice what was, in fact, going on at that time. We didn't extend the timeline to the priorities right now, but we have not changed it since that point. Okay, that's helpful. And then in terms of, I guess, maybe a question for Charlie, you kind of portrayed a best case scenario of 2037 for if everything goes in your direction with the litigation with Tevlin Sun. Can you help us understand in terms of maybe a base case scenario in terms of how things could progress on the other end of that spectrum when you could potentially see a generic competition the way things are playing out right now?

There are pieces of work that I'm not trying to pick up on the things that made up and stuff and.

Yeah.

Okay.

Thank you very much and I can go up in the province.

Matthew Kaplan: Okay. Thank you very much. Congrats on the progress.

Matt Kaplan: Okay. Thank you very much. Congrats on the progress.

Operator 3: We'll go to our next question from Roger Song of Jefferies.

And well go through our next question from Robert.

Operator: We'll go to our next question from Roger Song of Jefferies.

Rather style of Jefferies.

Great [laughter].

Great. Thank you good afternoon. Thank you for taking my question.

Roger Song: Great. Thank you. Good afternoon. Thank you for taking my question. Maybe the first one goes into the Cushing's syndrome franchise. Do we see both of two potential new steroidogenesis inhibitors? Both of them are priced like a $300 to 400 million peak sales for Cushing's syndrome. Given Korlym already tracking this kind of a range, how would you kind of reconcile this to your expectations for your Cushing's syndrome franchise?

Maybe the first one goes in Q, the Cushing syndrome franchise.

So we see a close up to potentially new steadily generics is inhibitor therapy.

Most of them are a guy like kind of 300 to 400 million peak sales of of course anything dramatically and again.

Colin already tracking this kind of a range and how would.

Would you have a good solid bids to your expectation for your question because they'll try to charge.

No I I apologize, but really if you were breaking up at night because probably.

Joseph K. Belanoff: Roger, I apologize, but really you were breaking up, and I, we caught probably 50% of what you were saying. Could you please repeat it? I'm sorry to make you do that, but I don't, I wanna make sure that we answer the question you want answered. Now we're getting 0% of what you're saying.

Joseph Belanoff: Roger, I apologize, but really you were breaking up, and I, we caught probably 50% of what you were saying. Could you please repeat it? I'm sorry to make you do that, but I don't, I wanna make sure that we answer the question you want answered. Now we're getting 0% of what you're saying.

What you are saying could you. Please if you could I haven't started they can do that but I don't want to make sure that we answer the question do you want to answer.

Gary Charles Robb: Well, the 2037 date I mentioned is just the date of kind of our longest running patent and the one also that's being challenged now at the PGR that we built. As I mentioned, you'll have an important decision about in a couple of weeks, in fact, in the Patent Office. So that's what the 2037 date runs to. And as for, you know, sort of bracketing...

Now, we're getting euros anyway.

Operator 2: Roger, can you repeat since we can't hear you?

Operator: Roger, can you repeat since we can't hear you?

Right.

We can't hear you.

Joseph K. Belanoff: Maybe Roger can repeat it to you guys, and then we can move to the next question. Yeah.

Joseph Belanoff: Maybe Roger can repeat it to you guys, and then we can move to the next question. Yeah.

Right the Bagger Dave's and is.

Yes.

Kick in you know.

Roger Song: Can you hear me now?

Yes, Yeah, now we can better yet.

Joseph K. Belanoff: Yes. Yeah, now we can. How about yeah.

Joseph Belanoff: Yes. Yeah, now we can. How about yeah.

Okay, Great all right so.

Roger Song: Okay, great. All right. I just try to understand this. We have two new steroidogenesis inhibitors. They are kind of guiding $300 to 400 million peak sales for Cushing's syndrome. Given Korlym already tracking this range, how do you reconcile this to your expectation for the Cushing's syndrome franchise for Korlym and the potential kind of vertical event?

I just try to understand this so we have two new stairway to Memphis Kibodeaux, there I'm kind of a guidance. So you have that you are finding them keep sales for Cushing syndrome and to give him a call them already traction this year olds and the how do you as it consolidates.

Operator: Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Unknown Speaker, Unknown Attendee, Swayampakula Ramakanth, Gary Robb, Joseph Belanoff, Gregory Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Okay. Okay. That

Through our expectation for the Cushings franchise, while four column and the potential comes out of one of them.

Matthew Lee Kaplan: And then just in terms of a pipeline question, if I may, the Reliant Phase 3 study, you mentioned that data from the first half of the study, the first 40 patients, would be available in the first half of 21. I guess, what should we be looking for with respect to the primary endpoint objective response rate? Is that the data we're going to see in the first half and the first 40 patients? The interim analysis that we're planning from this... basically, giving us a first look. And finally, at that point, not powered to make any definitive conclusions, but it is that there is communication on where we are and where we're tracking towards success. And it will obviously give us a highway.

Rather than just.

Sean Maduck: Roger, this is Sean Maduck, the Chief Commercial Officer. Just to clarify, I think you're asking if Theriva is projecting a $400 million market, what is the impact into our business? Is that what you're asking?

Sure.

Are you asking wachovia.

If you leave it like that.

$180 Arvind, what if you can back into our business.

Okay.

Yep Yep.

Roger Song: Yeah. Yep.

Yeah. So it opens specifically I would say right now there's there's been minimal impact.

Sean Maduck: Specifically, I would say right now there's been minimal impact with the approval of Isturisa. I just want to point out a couple of quick things to those on the call. Isturisa is a medication that has a mechanism of action that's very similar to a low price medication, ketoconazole, that is sometimes used off-label to treat Cushing's disease. The other important point here is that Isturisa is indicated for Cushing's disease and not the broader Cushing's syndrome spectrum or all etiologies of Cushing's syndrome.

The approval of mysteries, though that's what went on a couple of things so those on the call.

To read it.

Medication that hasn't mechanism mechanism of action is very similar to that.

Great Medicaid that's higher than the third is sometimes used off label to treat the <unk>.

When when when you're is that degree, but as is indicated workers in the <unk> and not be broader cushings syndrome spectrum are already alters the pigeons.

<unk>.

Okay got it thank you.

Roger Song: Okay. Got it. Thank you. Maybe next question for relacorilant. We see that you're going to select the dosing next quarter, Q1 next year. Just curious, what needs to be done to select the dose, and I believe last quarter you guided towards this, the end of this year. I'm just curious, what delays for the dosing selection?

Okay. Maybe next question left for the X. Carlin, So we see that youre going to select the dose yet next call to another <unk> said first quarter next year.

Andres Grauer: It is an encouragement to continue the trial lab at NAE. Unknown Speaker, Unknown Speaker, Sorry, go on, go ahead, please. Yeah, just in terms of maybe you can help us understand what objective response rate would be deemed as successful. You know, I guess pancreatic cancer is, you know, obviously a very difficult indication.

But just curious what needs to be done to selected those and Ah I believe last quarter you guided towards the.

The end of this year. So I just curious about what the late for the dosing selection.

Andres Grauer: Unknown Speaker 0, Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc. Unknown Speaker So, any response would probably be an improvement for these patients. Water for Accelerated Approval with NCXA is a significant bar, and in their own words, they like to be volatile.

Oh really.

We have we started the next segment.

Andreas Grauer: We have started the next segment of our phase 1/2 trial, which will hopefully lead us to a dose for Relacorilant. We started that before trial, and the times of COVID has taken a little longer than we were hoping it would. The trials have been running and recruiting patients, and we hope as a result of that, we will be able to make that decision. I also want to remind people that we actually have two parallel trials ongoing. One that we're running ourselves, which is the Relacorilant trial that you just mentioned. In collaboration with the University of Chicago, there is an investigator-sponsored trial with

Our phase one.

Trial.

Which limited.

They need us to the to a series of Fracs Korlym.

HM.

Starting up a new trial.

The type of credit has taken longer than the weather they were hoping it would.

Operator: [inaudible] Thank you very much and congratulations on the project. And we'll go to our next question from Robert Rogersong of Jeff. Great. Great. Thank you. Good afternoon.

Putting patients and as a result of that.

We'll be able to make that decision Oh my God.

Yeah, and we actually had to.

Robert Rogersong: Thank you for taking my question. Maybe the first one will go into the Caution Syndrome franchise. Though we see both of these potential new steroid geneticist inhibitors, both of them are guys like a 300 to 400 million peak cells for Caution Syndrome. And given Colin is already tracking this kind of range, how would you kind of reconcile this to your expectations for your Caution Syndrome franchise? Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Gregory Fraser, Edward Nash, Leon Wang, Arthur He, Unknown Executive, Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc. Now we're getting 0% of what you' Unknown Speaker, I can't hear you.

Oh well.

And once again.

Sounds good.

Reaches the sparling trials.

But it's usually you mentioned and then and collaboration between what's your Chicago.

There was an investigator sponsored trials another call.

Roger Song: Got it. Okay. That's fair. Okay, great. Thank you. That's all my questions. Sorry for the connection.

Lisa It's you population of prostate cancer patients.

And if I know, it's probably at least 200, though those trials to be able to make a decision on <unk>.

What we want to be over.

Got it.

Okay. That's fair Okay, great. Thank you that's all they're all my question.

The the connection.

Right right.

Joseph K. Belanoff: Thank you, Roger.

Joseph Belanoff: Thank you, Roger.

And well move to our next question from Mark Ramakanth of H.C. Wainwright.

Operator 3: We'll move to our next question from Ramakanth of H.C. Wainwright.

Operator: We'll move to our next question from Ramakanth of H.C. Wainwright.

I'm good I, just want to check and see if you guys can get my wife's clearly because I've been having a very choppy even.

Swayampakula Ramakanth: Thank you. I just want to check, see if you guys can hear my voice clearly, because I've been having a very choppy evening.

Ramakanth Swayampakula: Thank you. I just want to check, see if you guys can hear my voice clearly, because I've been having a very choppy evening.

Operator: [inaudible] Um, can you hear me now? Yes. Yeah, now we can. Okay, great. Sorry.

Yes, we can hear you.

Joseph K. Belanoff: Yes, we can hear you.

Joseph Belanoff: Yes, we can hear you.

Yeah.

[laughter], Okay. So just trying to understand the full corridor.

Swayampakula Ramakanth: Okay.

Ramakanth Swayampakula: Okay.

Joseph K. Belanoff: Yeah, we can.

Joseph K. Belanoff: Okay. Just trying to understand Q3, you know, the revenue run and also trying to understand the guidance that you put out. Based on your guidance, if I take the midpoint, you know, you're expecting approximately about 6% growth from a Q3 base. Just trying to understand the confidence for that number and, is there a possibility, you know, to do closer to your previous guidance and at the upper end of your previous guidance?

Joseph Belanoff: Yeah, we can.

Ramakanth Swayampakula: Okay. Just trying to understand Q3, you know, the revenue run and also trying to understand the guidance that you put out. Based on your guidance, if I take the midpoint, you know, you're expecting approximately about 6% growth from a Q3 base. Just trying to understand the confidence for that number and, is there a possibility, you know, to do closer to your previous guidance and at the upper end of your previous guidance?

You know the revenue run and also I'm trying to look to try and understand.

Robert Rogersong: So, I just tried to understand this. So we have two new steroidal genesis inhibitors. They are kind of guiding 300 to 400 million tick cells for Cushing's syndrome. And given Colin is already tracking this range, and how do you reconcile this to your expectation for the Cushing's syndrome franchise for Colin and the potential kind of rare colonists? Roger, this is Sean Maduck.

The guidance that you have put out so based on your guidance.

Ah if I take the midpoint now you're expecting up approximately 6% growth.

From some some are somewhat third quarter basis. So I'm, just trying to trying to understand the confidence for that number on.

Sean Maduck: Interacting with one entity at a time. Interleague is what they're after now. I think it's a $400 million market. What if we can integrate it into our business?

Is that a possibility there now to do closed out they are or previous guidance and at the upper end of your previous guidance.

Sean Maduck: Is that what you're asking? Yeah, yep. Yeah, so specifically, I would say right now that there's been minimal impact with the approval of Histiriza. I just want to point out a couple of quick things to those on the call. Histiriza is a medication that has a mechanism of action that's very similar to a low-priced medication, Tyrofim, that is sometimes used off-label to treat Christian's disease.

They are they before you start I didnt get a chance they always liked to introduce a shot and try to do things like commercial officer, and let him answer that question.

Sean Maduck: Hey, Ram, before you start, I didn't get a chance to. I always like to introduce Sean Maduck, who's our Chief Commercial Officer, and let him answer that question. Yeah, thanks for the question, and I'm gonna answer it in two parts. I first wanna talk about sort of what's happened over the pandemic and then talk a little bit about sort of expectations for Q4. There are two key drivers to our revenue, two key components. One is patient retention and then the second is new patient acquisition. During this COVID window, we've done well on retaining patients, but acquiring new patients has been challenging. Joe talked about this during the opening remarks. There's three key factors I think that have impacted us over the last six months.

Joseph Belanoff: Hey, Ram, before you start, I didn't get a chance to. I always like to introduce Sean Maduck, who's our Chief Commercial Officer, and let him answer that question.

Yeah. Thanks for the question and then I'm going to answer into Bert I first want to talk about sort of what's happened over the pandemic them and.

Sean Maduck: Yeah, thanks for the question, and I'm gonna answer it in two parts. I first wanna talk about sort of what's happened over the pandemic and then talk a little bit about sort of expectations for Q4. There are two key drivers to our revenue, two key components. One is patient retention and then the second is new patient acquisition. During this COVID window, we've done well on retaining patients, but acquiring new patients has been challenging. Joe talked about this during the opening remarks. There's three key factors I think that have impacted us over the last six months.

Talk a little bit about sort of expectations for Q4. So there are two key drivers or rather the two components. One is the speech and retention and then the second is new patient acquisition.

Sean Maduck: The other important point here is that Histiriza is indicated for Christian's disease and not the broader Ching's syndrome spectrum or all etiologies of Christian's syndrome. Okay, got it. Thank you. Okay, maybe next question for the ex-quarterland. So we see that you're going to select the dose next quarter, the first quarter next year. And I'm just curious, what needs to be done to select the dose

During this call that window is unwell 13 patients, but acquiring new patients has been challenging and Joe talked about this during the opening remarks.

There's really three key factors I think that their practice for the last six months of the burst it varies state by state, but position to move to a more of a hybrid model personally. So another thing that's been the Nazis Asian tip, it seems pretty good too.

Joseph K. Belanoff: And I believe in the last quarter you guided it towards the end of this year. So I'm just curious, what delays were there in the dosing selection? We have restarted the next segment of our phase one slash two trial, which will lead us to a device for hexachorlin. We started our doctor trial at a time when COVID has taken longer than we were hoping it would. The trial's up and running, and we're recruiting patients, and we hope as a result of that we will be able to make the decision. I also want to remind people that we actually have two, and one that we're running ourselves, which is the Exabarlin trial that you just mentioned.

Sean Maduck: The first, it varies state by state, but physicians have moved to a more of a hybrid model of in-person and telemedicine appointments, and they're not seeing patients at the same frequency that they have previously, in pre-pandemic. Screening and diagnosis rates are down, which of course impacts the patient's ability to get diagnosed, to then get treated, and then to get to an optimal treatment regimen. That's point one. Point two, even if patients are able to go see their physicians or to go get labs, they've been very sick patients, and due to preexisting conditions and fear of the virus, they haven't been going.

Previously I agree pandemic still screening and diagnosis rates are down but of course it back for patients ability to do that I noted to then get treated and then to get to them up in their treatment regimens. The full one point do even if patients are able to go through their positions were to go get louder they've been very reluctant to do so there's a very very sick.

Patients do the pre existing conditions I'm going to go the virus they haven't been doing and the third piece is there's a bit although practices and health systems have been open to see patients. How many have been close to the pharmaceutical industry, which impacts our ability to to educate new potential prescribers. So as Joe mentioned we.

Sean Maduck: The third piece is that although practices and health systems have been open to seeing patients, many have been closed to the pharmaceutical industry, which impacts our clinical affairs force's ability to educate new potential prescribers. As Joe mentioned, we've moved to virtual technology platforms and we're doing what we can and trying new things to reach physicians when in-person interaction is not feasible. In terms of Q4, you know, it takes time for a patient to be diagnosed. It takes time for a patient to potentially be put on Korlym, and then it takes time for them to get to an optimal dose where we ultimately see a business impact. There's a lag on that that's a few months.

Joseph K. Belanoff: And then, in collaboration with the University of Chicago, there has been an investigative response to the trial of Ramakanth for a similar patient option. By the end of the first quarter, we hope to have results of both of those trials to be able to make a decision on what we want to move forward.

Moving to our technology platforms, and the doing what we can and try new things to to reach positions with two person interaction is not feasible.

Robert Rogersong: Okay, that's fair. Okay, great. Thank you. That's all my questions.

Operator: Sorry about the connection. Thank you. Thank you. And we'll move to our next question from... Swayampakula Ramakanth of H.C. Wainwright. Thank you. I just want to check and see if you guys can hear my voice clearly because I've been having a very choppy evening. Yes, we can hear you.

Well in terms of Q4.

It's time for a vision to be diagnosed if it's time for a patient to potentially be put on Korlym and then it takes time for them to get to an optimal dose that we ultimately see a business and so there's there's a lag on that topic.

Swayampakula Ramakanth: So, just trying to understand the third quarter, the revenue run, and also trying to understand the guidance that you put out. So, based on your guidance, if I take the midpoint, you're expecting approximately 6% growth from a third-quarter base. So just trying to understand the confidence level for that number, and is there a possibility to do closer to your previous guidance and at the upper end of your previous guidance? Before you start, I'll give you a chance to introduce Sean Maduck, our Chief Commercial Officer, and let him answer that question. Yeah, thanks for the question. And I'm going to answer it in two parts. I first want to talk about sort of what's happened with the pandemic and then talk a little bit about sort of expectations for Q4. So there are two key drivers of our revenue, two key components.

A few months. So there's already mentioned there was definitely a significant slowdown of physician interaction in Q2, I whenever things are shut down with the onset of appeal the Nike than not.

Sean Maduck: I already mentioned there was definitely a significant slowdown of physician interaction in Q2, when everything sort of shut down with the onset of COVID-19. That slowdown impacted Q3. Now, the change is that things have opened up somewhat in Q3. There was an increase in activity, and I expect that will benefit our Q4.

In fact in Q3.

The changes that things have picked up somewhat in the third quarter. There wasn't a resurgence in activity and I expect that that will benefit or before.

Thank you. Thank you for that and then the next question is younger than Dipankar pancreatic cancer trial.

Swayampakula Ramakanth: Thank you for that. The next question is on the pancreatic cancer trial. I understand from your initial comments that, you know, you have the data from the first 40 patients in Q1 2021. Could you give us an idea of when you could complete this study, and the data from this study is positive, is that enough to file for an approval, or do you need to do another study?

Ramakanth Swayampakula: Thank you for that. The next question is on the pancreatic cancer trial. I understand from your initial comments that, you know, you have the data from the first 40 patients in Q1 2021. Could you give us an idea of when you could complete this study, and the data from this study is positive, is that enough to file for an approval, or do you need to do another study?

Oh I understand from your commitment initial comments that somebody has the data from towards 40 patients in the fourth quarter of Sunday lunch.

Good.

Oh, you give us an idea of then you could complete that study and the data from.

The study is positive.

Got enough two five part on that for a while or do you need to do another study.

Sean Maduck: One is patient retention, and then the second is new patient acquisition. During this COVID window, we've done well with retaining patients, but acquiring new patients has been challenging, and Joe talked about this during his opening remarks.

[noise] [laughter].

Andreas Grauer: I think we said H1, right?

I think you said first half.

Andreas Grauer: I think we said H1, right?

I'm not quite up 91.

Swayampakula Ramakanth: I meant Q1 2021.

Ramakanth Swayampakula: I meant Q1 2021.

Yeah, but I think we said first topic trend one but for all the individual.

Andreas Grauer: I think we said H1 2021, so for when we will have the data on that study. Again, it's an interim analysis of 40 patients currently. The current trial design requires up to 80 patients, so it would be a doubling of that size. It obviously depends on the speed of enrollment that we would have. What we currently think is that we should have some data in about, like, for the overall trial about 9 to 12 months later.

On that study I think that that's an interim analysis.

20 patients currently.

Sean Maduck: So there are three key factors, I think, that have impacted us over the last six months. And the first, it varies state by state, but physicians have moved to more of a hybrid model of in-person and telemedicine appointments, and they're not seeing patients at the same frequency that they did previously in pre-pandemic. So screening and diagnosis rates are down, which, of course, impacts the patient's ability to get diagnosed, to then get treated, and then to get to an optimal treatment regimen. So that's point one.

Uh huh.

Ah requirements.

Requirements are more anyway, so it would be a doubling the size.

Yes, it depends on the leases that enrollment.

But.

Our current thinking is that true.

Sure.

The data and.

Like for the for the overall.

Uh huh.

Nice are troubling later.

It is easy to other second question RK, Yes, we think that with sufficient results that study would be.

Joseph K. Belanoff: As an answer to your second question, RK, yes, we think that with sufficient results, that study would be the one the FDA would accept for an NDA. Cross our fingers. It's obviously result dependent, but this is a very ill group of patients with really not much else to help them. The FDA's pretty interested, but it's on us to see if our drug produces the acceptable results.

Joseph Belanoff: As an answer to your second question, RK, yes, we think that with sufficient results, that study would be the one the FDA would accept for an NDA. Cross our fingers. It's obviously result dependent, but this is a very ill group of patients with really not much else to help them. The FDA's pretty interested, but it's on us to see if our drug produces the acceptable results.

When the FDA would sell for in India, So plus our fingers. It's obviously result in there but.

You know Gary illegally the patients is really not much else to help them.

Sean Maduck: Point two, even if patients are able to go see their physicians or go get labs, they're very reluctant to do so. These are very, very sick patients, and due to pre-existing conditions, if you hear the virus, they haven't been born. And the third piece is that although practices and health systems have been open to seeing patients, many have been closed to the pharmaceutical industry, which impacts our clinical process ability to educate new potential prescribers. So, as Joe mentioned, we've moved to virtual technology platforms, and we're doing what we can and trying new things to reach physicians when in-person interaction is not feasible. So in terms of Q4, you know, it takes time for a patient to be diagnosed, it takes time for a patient to potentially be put on Coralim, and then it takes time for them to get to an optimal dose, so we ultimately see a business impact. So there's lag time for a few months, and I already mentioned there was definitely a significant slowdown of physician interaction in Q2, when everything sort of shut down with the onset of Now, the change is that things have opened up somewhat in the third quarter.

It's pretty interesting.

See if I go to <unk>.

So.

Okay. Thank you gentlemen, thanks for taking my questions.

Swayampakula Ramakanth: Okay. Thank you, gentlemen. Thanks for taking my questions.

Ramakanth Swayampakula: Okay. Thank you, gentlemen. Thanks for taking my questions.

No.

And we'll go to Alan <unk> fire watchman.

Operator 3: We'll go to Alan Leong of Firewire News.

Operator: We'll go to Alan Leong of Firewire News.

Hi, Joe had Charlie and I have a baby care Andreassen Sean.

Alan Leong: Hi, Joe. Hi, Charlie, and good evening to you, Andreas and Sean. I appreciate that it's on election day, so I won't ask you if you voted and who for.

Oh I appreciate that saw election day, so I won't ask you have you voted for.

[laughter] yeah.

Andreas Grauer: Yes. Yes. Yes, we did.

Joseph Belanoff: Yes.

Charlie Robb: Yes.

Andreas Grauer: Yes, we did. [crosstalk]

[laughter].

Alan Leong: Let me ask you, actually, you know, I'll first go over something over the GRATITUDE trials. You briefly talked about this about, I think about six months ago, but which GRATITUDE trial has a more difficult enrollment proposition among investigators? If so, when you comment, can you compare the trial enrollment execution of the two, GRATITUDE versus GRATITUDE II? Let me slip in a second question. I'm sorry to do that. What's the endpoint goal for GRATITUDE? Because I remember the healthy normal trial that you were just looking for a trend rather than statistical significance. I wanna set expectations.

Well, let me ask you access you know first go over something.

Well with the gratitude trials.

And you briefly talked about that's about I think about six months ago, but which gratitude trial has a more difficult in enrollment proposition among investigators and if and if.

So when you can that can you compare that compare the trial enrollment execution of the two gratitude one versus gratitude to them. What do you put a slip in the second question, it's hard to do that or what the city.

I'm sorry.

I'd point goal for gratitude, one because I remember the healthy normal trial that you were just looking for a trend rather than the statistical significance I want to set expectations do you have a low dealt with their work old formulation and I know you've got a little bit of a bar because you're dealing with Ah Ah Ah obese patients.

Alan Leong: You have a low dose with the old formulation, and obese patients. Yep.

Sean Maduck: There was an increase in activity, and I expect that that will benefit our patients. Thank you for that. The next question is about the pancreatic cancer trial. I understand from your initial comments that you will have data from the first 40 patients in the first quarter of 2021. Could you give us an idea of when you could complete this study? If the data from this study is positive, is that enough to file for approval, or do you need to do another study? Well, thank you. I think we've got the first half done. I'm in the first quarter, 21. Yeah, but I think we said the first half of 21.

Oh.

Yep.

Yeah. Thank you for the questions. So first of all three who then has to offer.

Andreas Grauer: Yeah. Thank you for the question. First of all, the GRATITUDE trial is enrolling patients with recent weight gain, versus the GRATITUDE II trial, which is enrolling patients with long-standing weight gain. The recent weight gain is usually somewhat harder to document. That trial is sometimes more difficult to enroll. We started it earlier, so we think we will probably get the results for both trials at about the same time, around Q2 2022. The trial is powered to detect a 5% reduction in weight. Again, we're obviously relatively early in this program, but if you compare it to the healthy volunteer trials, you have to keep in mind that the healthy volunteers, these were two-week trials.

HM.

And when they make and he would since June two trial.

And then.

Once I'm thinking.

And the reason they came in they are somewhat hard to truly two documents and so that is something that.

The difficult kind of wrong.

Certainly the early years, we would probably have to report we filed at the same time from Q2.

I am too.

HM.

Hi evidence college.

5%.

That's right and reduction in late.

And then again, what did you learn from the others of them but.

Swayampakula Ramakanth: And again, anyone else? Unknown Speaker, Unknown Speaker, Unknown Speaker. And in answer to your second question, R.K., yes, we think that with sufficient results, that study will be the one the FDA would accept for an NDA. So, cross our fingers. It's obviously result-dependent, but this is a, you know, very ill-advised patient, really not much else. Speakers, Unknown Attendee, Swayampakula Ramakanth, Aaron Leong, Gregory Fraser, Unknown Attendee, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc. Okay. Thank you, gentlemen. Thanks for taking the question. And we'll go to Leon if I... Hi Joe.

Parents balance sheet drives.

Okay opportunities.

<unk> trials.

Andreas Grauer: This is a three-month trial. The extent of effect will obviously be impacted by the duration of treatment as well.

Ah so.

Same doesn't affect him.

Well, obviously be tech duration.

Exactly.

Joseph K. Belanoff: I mean, that's exactly right. The only thing I'd add to that, Alan, is just to your point, we were really looking in the phase 1 trial in healthy volunteers to see if the medication was really very active in animals. Indacaterol study, you know, had shown statistically significant results, also in the healthy volunteer study of, I guess, similar character, 2 weeks of treatment. We were really very pleasantly surprised to see that we got statistically significant results, Liraglutide as well. Now all that said, Andreas has described to you a study that's really different. It's in patients, it's about weight reduction as opposed to prevention of weight gain. We're optimistic because we think this drug is really very potent and at least we think that it is.

Joseph Belanoff: I mean, that's exactly right. The only thing I'd add to that, Alan, is just to your point, we were really looking in the phase 1 trial in healthy volunteers to see if the medication was really very active in animals. Indacaterol study, you know, had shown statistically significant results, also in the healthy volunteer study of, I guess, similar character, 2 weeks of treatment. We were really very pleasantly surprised to see that we got statistically significant results, Liraglutide as well. Now all that said, Andreas has described to you a study that's really different. It's in patients, it's about weight reduction as opposed to prevention of weight gain.

After that I'll is just really voice Uh huh.

We're really looking at a phase one im sorry, yes.

Phase one trial Dol, if you see the Medicaid or was that it was very active animals and get the president had show it.

It was a good results also healthy volunteer study similar character to two weeks of treatment.

Hmm like very pleasantly surprised to see them together.

It was also the.

Well now all that said Ah Andres described you say, that's really different seeing patients it's about weight reduction.

Alan Leong: Hi Charlie and Dede to Andreas and Sean. I appreciate that it's on election day, so I won't ask you if you voted and for whom. Yes, he helped me. Let me, let me ask you something. Actually, you know, I'll first go over something, the gratitude trials. And you briefly talked about this, I think about six months ago, but which gratitude trial has a more difficult enrollment proposition among investigators? And if so, when you comment, can you compare the trial enrollment execution of the two, Gratitude I versus Gratitude II? And let me slip in a second question before I do that.

They have weighed eight so we're optimistic because we think its drugs really great.

Joseph Belanoff: We're optimistic because we think this drug is really very potent and at least we think that it is. These are the first two studies that we've run to actually test that hypothesis in patients on weight reduction.

It is but it is these are the first to say what I.

Joseph K. Belanoff: these are the first two studies that we've run to actually test that hypothesis in patients on weight reduction.

Actually test.

<unk> in patients with production.

Yeah. The two trials are really really quite a contrast for a number of reasons.

Alan Leong: Yeah. The two trials are really, really quite a contrast for a number of reasons. Let me ask you about the adrenal cancer trial, and this is really a thousand-foot view question. You know, I was pleasantly surprised you're going to Europe, North America, United States, and Israel. The trial is global. How does that dovetail with how you envision your eventual Cushing's program of expansion?

Well you know your buckets renal cancer.

Trial, and that's really what's isn't really a thousand what's your question.

Yeah, I was pleasantly surprised going to Europe, north a United States in Israel, the trough global how does that dovetail with how you envision your bench or Cushing with a program of expansion.

Joseph K. Belanoff: Endpoint goal for gratitude one because I remember the healthy normal child that you were just looking for a trend rather than statistical significance. I want to set expectations. You have a low dose with the old old formulation, And now you've got a little bit of a bar because you're dealing with obese patients. Yeah, thank you for the question. So, first of all, the Gratitude I trial is enrolling patients with recent weight gain versus the Gratitude II trial, which is enrolling patients with long-term weight gain. Recent weight gain is somewhat harder to document, so that trial is more difficult to enroll. However, we started it earlier, so we think we will probably get the results of both trials at about the same time, around Q2 2022. Unknown Speaker And the trial is powered, Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, Gregory Fraser, So the extent of the fact that... Unknown Speaker 0, I mean, that's exactly right.

Oh Im not really sure I follow your question.

Joseph K. Belanoff: Alan, I'm not really sure I follow your question.

Joseph Belanoff: Alan, I'm not really sure I follow your question.

[music].

Alan Leong: Mm-hmm.

But I think.

Joseph K. Belanoff: I think I have. You actually, if you wouldn't mind, you actually give me an opportunity to present an important point that you may remember 'cause you followed Corcept for a long time, but others may not, which is that Korlym is approved for all forms of Cushing's syndrome, including patients with adrenal cancer. Now, what we noted in patients with adrenal cancer is that it really was very meaningful in improving their Cushing's syndrome. As far as we can tell, it really did not do anything in particular, neither better nor worse than their cancer, although their quality of life actually clearly improved. The studies that we're doing with Relacorilant, GRACE and GRADIENT, are actually excluding patients with adrenal cancer. We're not testing that group there.

I I help.

Joseph Belanoff: I think I have. You actually, if you wouldn't mind, you actually give me an opportunity to present an important point that you may remember 'cause you followed Corcept for a long time, but others may not, which is that Korlym is approved for all forms of Cushing's syndrome, including patients with adrenal cancer. Now, what we noted in patients with adrenal cancer is that it really was very meaningful in improving their Cushing's syndrome. As far as we can tell, it really did not do anything in particular, neither better nor worse than their cancer, although their quality of life actually clearly improved. The studies that we're doing with Relacorilant, GRACE and GRADIENT, are actually excluding patients with adrenal cancer. We're not testing that group there.

But you actually I think it really like.

Yeah, I can give me an opportunity is at what point that you made it never did she bought of course it for a long time, others may not which is the qualities of crude but all four sub cushing syndrome, including patients with renal cancer now.

Now that we know the agency to treat the answer is that it really is very meaningful for you there Cushing syndrome, but as far as we can tell it really did not do anything in particular, either better or worse than their cancer over the quality of life actually silly.

Feed studies that were getting it well growing grades and.

They are actually excludes daves.

Between cancer, and so we're not suggesting that we do there and but we think that for the same reasons have recently gotten here as we think we can really offer clinical benefit in cushings syndrome patients or that adrenal cancer. The really interesting thing about it is what I talked about in my opening remarks is weather and it is.

Joseph K. Belanoff: We think that for the same reason, the reason we got here is we think we can really offer clinical benefit in Cushing's syndrome for patients who have adrenal cancer. The really interesting thing about it is, what I talked about in my opening remarks, you know, of course stems from an observation. The observation was immunotherapy, which is fantastic in lots of other cancers, does not seem to really work at all in patients who have adrenal cancer, whose tumors are producing cortisol, and that's about half the patients who have adrenal tumors. What we really were hoping to see is in addition to the benefit we think we can provide in Cushing's syndrome, which is really a meaningful benefit, can we also provide benefit in terms of tumor reduction and improvement in their oncologic situation? We're very excited to try.

Joseph Belanoff: We think that for the same reason, the reason we got here is we think we can really offer clinical benefit in Cushing's syndrome for patients who have adrenal cancer. The really interesting thing about it is, what I talked about in my opening remarks, you know, of course stems from an observation. The observation was immunotherapy, which is fantastic in lots of other cancers, does not seem to really work at all in patients who have adrenal cancer, whose tumors are producing cortisol, and that's about half the patients who have adrenal tumors. What we really were hoping to see is in addition to the benefit we think we can provide in Cushing's syndrome, which is really a meaningful benefit, can we also provide benefit in terms of tumor reduction and improvement in their oncologic situation? We're very excited to try.

Joseph K. Belanoff: The only thing I'd add to that, Alan, is just to your point: we were really looking in the Phase 1, I'm sorry, in the Phase 1 trial in Healthy Volunteers, the gene for the medication was active, really very active in animals, and Mr. Princeton, you know, had shown statistically significant results also in the Healthy Volunteers study, you know, similar character to what we saw. And we were really very pleasantly surprised to see that we got particularly significant results in the unicorn one as well. Now all that said, Andreas has described a new study that's really different. It's in patients; it's about weight reduction as opposed to prevention of weight gain. So we're optimistic because we think this drug is really very potent in the ways we think that it is. But these are the first two studies that we've run to actually test that hypothesis in patients with weight gain. Yeah, the two children are really quite a contrast for a number. Let me ask you about the adrenal cancer. This is really a 1,000-foot view question.

Stems from an observation observation was immunotherapy, which is fantastic and lots of other cancers does not seem to really work at all.

Well the answer is temperature for these four that's all about.

Page two.

And so.

Good to see it in addition to the benefit we think we can provide Cushing syndrome, which is really a meaningful benefit can we also provide better returns to a reduction in the food into logic situation where.

We're excited to try our investigators are very excited to try to try that and.

Joseph K. Belanoff: Our investigators are very excited to try that. You know, it seems like a very logical place for us to start because we thought we could at least know we can provide a benefit of some kind to these patients. Where that leads, I don't know, but we're very excited to really see what this first combination of immunotherapy and GR antagonist and GR modulation actually leads to.

Joseph Belanoff: Our investigators are very excited to try that. You know, it seems like a very logical place for us to start because we thought we could at least know we can provide a benefit of some kind to these patients. Where that leads, I don't know, but we're very excited to really see what this first combination of immunotherapy and GR antagonist and GR modulation actually leads to.

It seems like a very logical place for us to start, but we thought that at least know we can provide a benefit of certain kinds of these patients where they I mean I don't know that we're very excited to see his first combination therapy and GR antagonist GR modulation.

Yes.

And one last question I'd have to ask if you had that Cort one month, one start with six in phase one and the trial up from what I understand is completed how how was that and how do you tell your tickets forward at this point or and a world where if at all.

Alan Leong: One last question. I have to ask this. You had CORT113176 in phase 1, and the trial, from what I understand, is completed. How was it, and how do you intend to take it forward at this point or, where, if at all, will results be presented?

Alan Leong: I was pleasantly surprised to go to Europe, the United States, and Israel. Charles Global, how does that dovetail with how you envision your eventual cushioning program of expansion? Alan, I'm not really sure I follow your question. Thank you so much, Mr. Vice-President.

Oh, well result, the present it.

[laughter] divorce.

Joseph K. Belanoff: All right. First, Alan, as the guy who knows more about Corcept than, sometimes I worry, the people at Corcept, thank you for bringing up CORT113176. This is still a very early-stage compound. It's just in phase I at this point in time. You know, since we do a lot of work, you know, we're covering academics here, and we collaborate with a lot of active academics. You know, I'd also point out that CORT113176 in animal models related to nervous system diseases like ALS, Alzheimer's disease, and alcohol use disorder show very positive results, all of which is now in public, peer-reviewed journals, and so forth. This is a very interesting compound for us.

Joseph Belanoff: All right. First, Alan, as the guy who knows more about Corcept than, sometimes I worry, the people at Corcept, thank you for bringing up CORT113176. This is still a very early-stage compound. It's just in phase I at this point in time. You know, since we do a lot of work, you know, we're covering academics here, and we collaborate with a lot of active academics. You know, I'd also point out that CORT113176 in animal models related to nervous system diseases like ALS, Alzheimer's disease, and alcohol use disorder show very positive results, all of which is now in public, peer-reviewed journals, and so forth. This is a very interesting compound for us.

Alan I'm at the Guy who knows more about what has been a great people that of course that thank you for being on one wasn't we then said six but its still very early stage compound. It's just that in phase one at this point in time, but you know we are really a lot of recovering.

Joseph K. Belanoff: I have a little... but you actually give me an opportunity to present an important point that you may remember because you've followed Corcept for a long time, but others may not, which is that Coral is approved for all forms of therapy, including patients with adrenal cancer. Now, what we noted in patients with adrenal cancer is that it really was very meaningful in improving their Cushing syndrome, but as far as we could tell, it really did not do anything in particular to make it better or worse than their cancer, although their quality of life actually clearly improved. The studies that we're doing with Well World, Grace, and, We are actually excluding patients with adrenal insufficiency, And so we're not testing that group there.

Recovering academics here and we collaborate a lot of active academics you I also point out, but more likely upside exists in animal models related to notice you said geez is like eight less alzheimers disease and alcohol use disorder show very positive results.

The public computers to drugs and so so this is a very interesting for us, we're particularly interested and its effect is less because not only did we see any animal model a prevention at the client would see you actually saw statistically.

Joseph K. Belanoff: We're particularly interested in its effect in ALS, because not only did we see in the animal model a prevention of the decline of the disease, we actually saw statistically significant improvement. This was a study done by one of our collaborators at the University of Buenos Aires in Argentina. Now, on the plus side, ALS is a terrible disease. Even the approved treatments don't do much, and it'd be wonderful to be able to provide you know, an improvement for these particular patients, a therapeutic for this group of patients. On the other side is sadly, the trial to ALS approval is littered with many, many medications that did not work. It's a hard call as to what to do. Now, you're a little bit ahead of us. We're just at the end of phase 1.

Joseph Belanoff: We're particularly interested in its effect in ALS, because not only did we see in the animal model a prevention of the decline of the disease, we actually saw statistically significant improvement. This was a study done by one of our collaborators at the University of Buenos Aires in Argentina. Now, on the plus side, ALS is a terrible disease. Even the approved treatments don't do much, and it'd be wonderful to be able to provide you know, an improvement for these particular patients, a therapeutic for this group of patients. On the other side is sadly, the trial to ALS approval is littered with many, many medications that did not work. It's a hard call as to what to do. Now, you're a little bit ahead of us. We're just at the end of phase 1.

Joseph K. Belanoff: And we think that for the same reason, the reason we got here is that we think you can really offer clinical benefit in Cushing's syndrome for patients that have adrenal cancer. The really interesting thing about it is, what I talked about in my opening remarks, whether it's the first steps from an observation. And the observation was that immunotherapy, which is fantastic in lots of other cancers, does not seem to really work at all in patients with adrenal cancer, whose tumors are producing cortisol, and that's about half.

The improved state by one of our collaborator University flats artisan, Argentina now on the bus side Payless is a terrible disease, even they approved treatment. So it'd be much it'd be wonderful to be able to provide.

It's pretty.

Are these purchases based therapies.

Patients on the other side is sadly the trail to aid us approval.

You need the medications that did not work so it's a hard call we'd love to do now you're a little bit.

Joseph K. Belanoff: [inaudible] a benefit of some kind to these patients. We're not new, I don't know, but we're very excited to see this first combination of immunotherapy and GR antagonism, GR modulation. And one last question. I have to ask this. We had court 113176 in phase one, and the trial, from what I understand, is completed. How was it?

Yes, we're just at the end of Phase one and then it's up to go here, but probably the time that they let say speed.

Joseph K. Belanoff: We have a little stuff to go here. Probably by the time, by the next time we speak, we'll be able to give an answer to that question.

Joseph Belanoff: We have a little stuff to go here. Probably by the time, by the next time we speak, we'll be able to give an answer to that question.

You can answer that question.

Thank you I appreciate it.

Alan Leong: Thank you. I appreciate it.

All right, it's like email hobbies your yeah, hopefully hopefully in a productive way. Thank you very much for all to the yen and we will talk to you all in the quarter. Thanks very much.

Joseph K. Belanoff: All right. It looks like we have used your hour, hopefully in a productive way. Thank you very much for all tuning in, and we will talk to you in a quarter. Thanks very much. Bye-bye.

Joseph Belanoff: All right. It looks like we have used your hour, hopefully in a productive way. Thank you very much for all tuning in, and we will talk to you in a quarter. Thanks very much. Bye-bye.

Okay and that does conclude the call we'd like to thank everyone for your participation you may now disconnect.

Operator 3: Again, that does conclude the call. We would like to thank everyone for your participation. You may now disconnect.

Operator: Again, that does conclude the call. We would like to thank everyone for your participation. You may now disconnect.

Joseph K. Belanoff: Do you intend to take it forward at this point? And where, if at all, will the results be presented? So first, Alan, as a guy who knows more about Corcept than some of the great people at Corcept, thank you for bringing up Corp 113176. This is still a very early stage compound. It's just in phase one at this point in time, but we are really a lot of, you know, we're covering academics here, and we collaborate with a lot of active academics. I'd also point out that Corp 113176 and animal models related to nervous system diseases, like ALS, Alzheimer's disease, and alcohol use disorder, show very positive results, all of which have been published in peer-reviewed journals and so forth.

Joseph K. Belanoff: Good-

[laughter].

[noise] HM.

[noise].

[noise] App.

Joseph K. Belanoff: So this is a very interesting compound for us. We're particularly interested in its effect on ALS because not only did we see in the animal model a prevention of the client disease, but we actually saw a significantly significant improvement. This was studied by one of our collaborators at the University of Los Angeles and our team. Now, on the plus side, ALS is a terrible disease; even the improved treatments don't do much, and it would be wonderful to be able to provide, you know, an improvement for this particular group of patients, a therapy for this group of patients. On the other side, sadly, the trail to ALS approval is limited to many, many medications that do not work.

[noise] and.

Uh huh.

Yeah.

And [noise].

And.

[music].

Joseph K. Belanoff: So it's a hard call as to what to do. Now, you're a little bit ahead of us. We're just at the end of phase one. We have some stuff to go, but probably, by the next time we see you, I'll go to yellow.

Oh.

[music].

And.

[music].

And.

Operator: Thank you. I appreciate it. Alright, it looks like we have reached our hour, hopefully in a productive way. Thank you very much for all tuning in, and we will talk to you in a quarter. Thanks very much. Bye-bye. And again, that does conclude the call. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... [inaudible] Copyright Australian Broadcasting Corporation

[noise].

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