Q1 2020 Earnings Call

Good day, everyone welcome to the concept Therapeutics conference call todays.

Operator: Good day, everyone. Welcome to the Corcept Therapeutics conference call. Today's conference is being recorded. If you have a question during today's program, you may press star 1. At this time, I'd like to turn things over to Mr. Charlie Robb, Chief Financial Officer. Please go ahead.

The conference is being recorded.

During today's program.

Sorry.

At this time I lets turn things over to Mr., Charlie Robb Chief Financial Officer. Please go ahead.

Good afternoon.

Gary Charles Robb: Good afternoon. Today we issued a press release announcing our financial results for the first quarter and providing a corporate update. A copy is available at Corcept.com. Complete results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available through May 18th at 888-203-1112 in the United States and 719-457-0820 internationally. The passcode will be 282735

Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update copy is available of course up dotcom complete results will be available for our form 10-Q, one the FCC.

Today's call is being recorded.

Do you play will be available through March through May 18th at 8.803111 too in the United States and 70 194 or 570, we choose your own internationally. The pass code will be to wait to seven three fivenine.

Statements. During this call other than statements of historical facts are forward looking statements based on our plans and expectations that are necessarily subject to risks and uncertainties, which might cause actual results to differ materially from those such statements expressed or implied these risks and uncertainties include but are not limited to I believe.

Gary Charles Robb: Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are necessarily 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, generate sufficient revenue and cash reserves to fund our commercial operations and development programs, the availability of competing treatments, including generic versions of Coraline, and the initiation or outcome of litigation. Our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Coralim and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight, and other requirements, and 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 on our website and the SEC's website. Forward-looking statements on this call include those concerning our 2020 revenue guidance, cash flow, and our expected growth. The impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers, and patients

Operator business and achieve our goals grain cobot 19, pandemic and thereafter generate sufficient revenue and cash reserves to fund our commercial operations and development programs the availability of competing treatments, including generic versions of Korlym, the initiation or outcome of litigation.

Our ability to obtain acceptable prices at four 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 another requirements and the impact of the cold 19 pandemic on our employees consultants and vendors as well as onto that.

Additions patients insurers regulators and the practice of medicine generally.

These and other risks are set forth in or FCC filings, which are available at our website in the Fccs web site.

On this call forward looking statements include those concerning our 2020 revenue guidance cash flow and are expecting growth impact of the Golden Monkey and pandemic on our commercial operations financial performance clinical development development programs physicians payers and patients physician awareness of hyper corn is always.

Gary Charles Robb: Physician awareness of hypercortisolism and the selection of Coraline as the optimum medical treatment; The timing, cost, and outcome of litigation, including our lawsuit against Teva Pharmaceuticals and Sun Pharmaceuticals and Teva's challenge to our intellectual property before the patent, trial, and appeals boards. The scope and protective power of our intellectual property, the progress, enrollment, timing, design, and results of our clinical trials, and the clinical and commercial attributes of Relicorrelent, Exacorrelent, Miracorrelent, and our other selective cortisol modules. We disclaim any intention or duty to update this forward-looking statement. Our revenue in the first quarter was $93.2 million, a 44% increase from the first quarter of 2019. We have maintained our 2020 revenue guidance of between $355 and $375 million. First Quarter Gap Net Income was $30.1 million, compared to $18.3 million in the same period last year.

And that's what's your korlym as the optimum medical treatment.

The timing cost an outcome of litigation, including our law suit against Pemble, Teva Pharmaceuticals, and sometimes technicals and Kevin is challenged <unk> actual property before the patent trial, and Appeals board scope and protective power button or for property the progress enrollment.

Design and results of our clinical trials and the clinical and commercial attributes are going to correlate extra correlates mirror correlate and our other selective cortisol modulators.

We disclaim any intent your duty to update forward looking statements.

I will go into first quarter was $93.2 million, a 44% increase from first quarter of 2019, we've maintained our 2020 revenue guidance of between 355 and $375 million.

First quarter GAAP net income was $30.1 billion compared to 18.3 million in same period last year, excluding noncash expenses related to stock based compensation in the utilization or deferred tax assets together with related income tax effects non-GAAP net income in the first quarter was $41.2 million compared to.

Gary Charles 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 the first quarter was $41.2 million, compared to $24.3 million in the first quarter of 2019. Our cash and investments increased $33.7 million in the first quarter to a balance of $349 million at March 31st.

$24.3 million into first quarter of 2019.

Our cash and investments increased $33.7 million in the first quarter, two a balance of $349 million at March 31st.

Gary Charles Robb: Now, a brief legal update. In February, we prevailed in a challenge to the validity of one of our patents, the 348, brought before the Patent Office Trial and Appeals Board, or PTAB, by Neptune Generics, a subsidiary of the litigation finance firm Burford Capital. Neptune had threatened to attack the 348 patent unless we paid Neptune a substantial fee. We refused. As I reported on our last call, we won. PTAB found every claim of the 348 patent to be valid. I'm pleased to report on this call that Neptune did not appeal PTAB's decision. The matter is now closed. Our rights were wrongly attacked, and we defended them.

Now a brief legal uptick.

In February we prevailed in a challenge to the validity of one of our patents the three four.

For the patent office travel Appeals board or P. cab by Neptune Generics a subsidiary of the litigation Finance from Burford capital Neptune had threatened to attack the three for a <unk>, what we paid Neptune a substantial fee we refused.

As reported on our last call. We won the P. Chasetown every claim of the three four patent to be ballot I'm pleased to report on this call that net you did not appeal. The p. caps decision. The matter is now closed our rights were wrong. We attack them you defended the three four patent it will continue to play its part in our law.

Gary Charles Robb: The 348 patent will continue to play its part in our lawsuits against Teva and Sun, its validity bolstered by the PTAB's ruling in our favor. In March 2018, we sued Teva Pharmaceuticals to stop it from marketing a generic version of Coraline that would violate our patent. Our lawsuit stayed final FDA approval of Teva's proposed product until August 1st of this year. As we have been issued additional applicable patents over the past two years, we have asserted them against Teva. Our separate actions have now been consolidated, as we expected, into a single lawsuit, with trial scheduled to begin February 2, 2021. The discovery process is now underway. Kevin is also challenging the validity of one of our patents, the 214 patent, in a proceeding before the PTAP known as a post-grant review. PGR, for short.

Suits against tough insight, it's Bolivia bolstered by the P. tabs ruling in our favor.

In March 2018, we soon trouble pharmaceuticals to stop at some marketing a generic version of Korlym that would violating our patents are lawsuits stayed final FTC approval of type as proposed product until August 1st of this year as we have been issued additional applicable patents over the past two years weve asserted them against.

However, our separate actions have now been consolidated as we expected.

Single losses.

Charles scheduled to begin February 2nd 2021 discovery is now underway.

It is also challenging the validity of one of our patents that you're going for Pat.

In a proceeding before the P. chap known as a post grant review.

You are for sure.

Gary Charles Robb: Oral argument will take place in September, and there will be a decision in November. The losing party in a PGR may appeal to the Federal Circuit Court of Appeals, during which time those portions of the PTAB decision that are under appeal will have no effect.

Oral argument will take place in September there will be decision. This November.

Even party in a P.G. army appealed to the Federal Circuit Court of Appeals during which time those portions of the P. Type decision that are under appeal will have no effect appeals to the federal circuit, usually take about one year to resolve the soonest, we expect if somebody's of resolution of the P.R. is the fourth quarter of 2021.

Gary Charles Robb: Appeals to the Federal Circuit usually take about one year to resolve, so the soonest we expect definitive resolution of the PGR is the fourth quarter of 2021. In addition to Teva, Sun Pharmaceuticals is seeking to market generic coral.

In addition to Teva Sun pharmaceuticals, seeking to market generic Korlym, a patent infringement suit against sign testing you'd have to eat approval of SUNS proposed product until the earlier of December 820, 21, and the decision by the district Court that the patents, we have asserted against Sun arc invalid unenforceable or not infringed.

Gary Charles Robb: Our patent infringement suit against Sun has stayed FDA approval of Sun's proposed product until the earlier of December 8, 2021, and the decision by the district court that the patents we have asserted against Sun are invalid, unenforceable, or not infringed. Despite obvious overlap in subject matter and legal issues, our dispute with SUN is separate from our litigation against TEVA and is following its own timeline. A Markman hearing in the SUN case is set for November of this year, but a trial date has not been set. The impact of the COVID-19 pandemic on the timing of these disputes is impossible to know with certainty. However, PTAB has said it does not expect delays, which is not surprising. The Patent Office conducts much of its work, including PTAB hearings, remotely.

Despite obvious overlapping subject matter and legal issues are dispute with Sun is separate from our litigation against how about this following its own timeline.

<unk> been hearing in the Sun case is set for November of this year a trial date has not been set.

The impact of the Cobot 19 pandemic on the timing of these disputes is impossible to know with certainty that PJM has said it does not expect delays, which is not surprising.

In office conducts much of its work, including P type hearings remotely we expect a receiver ruling in RPG are in mid November as originally scheduled.

Predicting the ultimate timing of our district Court litigation is more difficult the court hearing our tenant and son in law suits as not delayed our February try what type of work November Markman hearing in the Sun case, and we were preparing on the assumption there'll be no delays that being said and pandemic related restrictions e. cheese, all courts will face a backlog.

Gary Charles Robb: We expect to receive a ruling in our PGR in mid-November, as originally scheduled. However,predicting the ultimate timing of our district court litigation is more difficult. The court hearing our Teva and Sun lawsuits has not delayed our February trial with Teva or our November Markman hearing in the Sun case, and we are preparing on the assumption there will be no delay. That being said, when pandemic-related restrictions ease, all courts will face a backlog of matters that take precedence over civil suits such as ours. Criminal cases, for example. I would not be surprised if our litigation timelines are extended. But, of course, that is for the court to decide, and we will be ready whether there are delays or not. We are confident in our intellectual property and look forward to putting our case before a judge. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer.

I'll give matters that take precedence over civil suits, such as ours criminal cases for example.

I would not be surprised if our litigation timelines are extended but of course that is for the court to decide and we will be ready whether there are delays or not we are confident in our intellectual property and look forward to putting our case before judge.

I'll now turn the call over to Dr., Joseph Stalin off our Chief Executive Officer Joe.

Thank you Charlie.

Yes, that's had an excellent commercial quarter.

Obstacles posed by stay at home orders and other measures to protect public health, our clinical specialist medical science liaisons patient advocates operation team operations team and specialty pharmacy made sure patients taking koala got their medication.

<unk>, 19, posters, and especially serious risk to patients with Cushing syndrome.

Excess cortisol activity suppresses the immune system.

Patients with Cushing syndrome, a four to five times more likely to suffer severe infections, putting them at exceptionally high risk for cobot 19.

Joseph K. Belanoff: Thank you, Charlie. Corcepts had an excellent commercial quarter. Despite obstacles posed by stay-at-home orders and other measures to protect public health, our clinical specialists, medical science liaisons, patient advocates, operations team, and specialty pharmacy made sure patients taking Quorum got their medication. COVID-19 poses an especially serious risk to patients with Cushing syndrome. Excess cortisol activity suppresses the immune system, so patients with Cushing syndrome are four to five times more likely to suffer severe infections, putting them at exceptionally high risk for COVID-19. They are also more likely to experience blood clots, another leading cause of morbidity and mortality in patients with COVID-19. Therefore, while it is always important that patients with Cushing's syndrome be diagnosed and optimally treated, it is especially important now. It is hard to predict how the pandemic will affect our commercial business for the rest of the year, but the risks COVID-19 poses to patients with Cushing syndrome are likely to increase demand for Coralib. At the same time, restrictions imposed by state and local governments, hospitals, and individual medical practices make it very difficult to work with physicians in person.

They are also more likely to experience blood clots, another leading cause of morbidity and mortality in patients with Kogut 19.

While it's always important the patients at Cushing syndrome be diagnosed and optimally treated it is especially important now.

It's hard to predict how the pandemic will affect our commercial business for the rest of the year.

The risks cobot 19 poses to patients with Cushing syndrome are likely to increased demand for Carlo.

At the same time restrictions imposed by state and local governments hospitals and individual medical practices make it very difficult to work with physicians in person.

Some of the imaging centers and laboratories position to use when diagnosing patients with Cushing syndrome, and tight trading through an optimum dose of coil are closed many patients are hesitant to lead their homes, you're going to visit the doctor. These factors are likely to reduce the rate, which new patients are introduced a korlym and make it more difficult.

Positions to monitor patients following dose titration.

However, as physicians and patients adaptable world in which cobot 19 years endemic as they are beginning to do the impact of these factors may diminish.

Joseph K. Belanoff: Some of the imaging centers and laboratories physicians use when diagnosing patients with Cushing syndrome and titrating to an optimum dose of Corleum are closed. Many patients are hesitant to leave their homes, even to visit the doctor. These factors are likely to reduce the rate at which new patients are introduced to Quorleum and make it more difficult for physicians to monitor patients following dose titration. However, as physicians and patients adapt to a world in which COVID-19 is endemic, as they are beginning to do, the impact of these factors may diminish. We reaffirm our 2020 revenue guidance of $355 to $375 million based on our strong first quarter results and our best estimate of how the factors that determine our revenue, pandemic-related and otherwise, will evolve over the coming months. As many of you know, we are conducting a Phase III trial of Relucoralant, our planned successor to Coralim, as a treatment for patients with CLI. The trial is known as great.

We reaffirm our 2020 revenue guidance of $355 million to $375 million based in our strong first quarter results at our best estimate how to factors that determine our revenue pandemic related an otherwise will evolve over the coming months.

As many of you know we're conducting a phase three trial umbrella clar led a plant successor to call them as a treatment for patients with Cushing syndrome.

Trials known as Grace.

Our goal for Grace just to confirm the positive efficacy and safety findings umbrella <unk> Lynch phase two trial in which patients exhibit meaningful improvements in glucose control and hypertension to Cushing syndrome, and most pernicious manifestations as well as an important secondary endpoints without instances korlyms significant off target.

Tax.

A poster presentation umbrella korlyms phase two results can be found at the investors slashed past events tab of our website.

We believe relative to our let will constitute a major medical and commercial advance walls phase two it efficacy data are comparable to korlyms at the same time points in Korlyms pivotal trial relic <unk> promises to offer significant safety benefits.

Joseph K. Belanoff: Our goal for GRACE is to confirm the positive efficacy and safety findings of Reliquorlin's Phase II trial, in which patients exhibited meaningful improvements in glucose control and hypertension, two of Cushing syndrome's most pernicious manifestations, as well as an important secondary endpoint, without instances of Quorlin's significant off-target effect. Our poster presentation of Rella-Corla Phase II results can be found at the Investor We believe Rella-Coagulant will constitute a major medical and commercial advance.

Clubs affinity for the glucocorticoid receptor G.R. for short makes it a highly effective treatment for patients with Cushing syndrome.

Fortunately Korlym is not selected for the G.R. It also bunch that progesterone receptor, which causes endometrial thickening and badgeville bleeding in many women regardless of age and requires korlyms label to carry a black box warning. The most serious medication warning required by the FDA for termination of pregnancy.

Quite different mechanism core little causes HEICO caveat little potassium a manageable, but potentially serious side effects that was experienced by 44% patients in korlyms pivotal trial, and it's a leading cause of discontinuation of patients taking the medication.

Joseph K. Belanoff: While its Phase II efficacy data are comparable to Quorulum's at the same time points in Quorulum's Pivotal Trial, Rola Quorulum promises to offer significant safety benefits. Quorum's affinity for the glucocorticoid receptor, GR, for short, makes it a highly effective treatment for patients with Cushing's syndrome. Unfortunately, Corleum is not selective for the GR.

Unlike well well acquire like it's just selected GR modulators no affinity for the for gestural receptor. It does not cause endometrial thickening or fashionable eating it is not the abortion pill.

Joseph K. Belanoff: It also binds to the progesterone receptor, which causes endometrial thickening and vaginal bleeding in many women, regardless of age, and requires Corleum's label to carry a black box warning, the most serious medication warning required by the FDA for termination of pregnancy. By a different mechanism, Corleum causes hypokalemia, or low potassium, a manageable but potentially serious side effect that was experienced by 44% of patients in Corleum's pivotal trial, and it's a leading cause of discontinuation in patients taking the medication. Unlike Quorulum, Rola-Quorulum is a selective GR modulator with no affinity for the progesterone receptor. It does not cause endometrial thickening or vaginal bleeding.

In addition, we saw no instances a drug induced tyco kyrenia relamorelin space will enter phase two studies. These are side effects physicians and patients would strongly prefer to avoid.

The cobot 19 pandemic, a slow the pace of enrollment in Grace and laid the opening of the last few of our plants 65 clinical trial sites.

As public health restrictions East, we expect our remaining sites to open and full enrollment to resume this fall we now plan to submit our and be a into second quarter Twentytwenty too.

This quarter, we will start phase three study abroad correlate in patients, whose Cushing syndrome is caused by an adrenal adenomas large renal hyperplasia.

The study is called gradient G.R.A.D.E.N. cheap.

It will be the first randomized double blind placebo controlled trial in patients with this etiology of Cushing syndrome.

Joseph K. Belanoff: It is not the abortion pill. In addition, we saw no instances of drug-induced hypokalemia with Reliquarol in Phase I or Phase II studies. These are side effects physicians and patients would strongly prefer to avoid. The COVID-19 pandemic has slowed the pace of enrollment in GRACE and delayed the opening of the last few of our Plan 65 clinical trial sites. As public health restrictions ease, we expect our remaining sites to open and full enrollment to resume this fall. We now plan to submit our National Action Plan in the second quarter of 2022.

Gradient has a plan enrollment at 130 patients 60 sites in the United States in Europe.

Recipients will receive either relic core lintel placebo for six months, but the primary endpoints being improvements in glucose metabolism and hypertension.

Many of the investigators for Grace will also participate and gradient.

Well again as part of our investment in development umbrella korlym to treat patients with hyper cores I'll listen it is not required park umbrella for lunch and da.

Goal is simply to helping foreign and approved the treatment of patients with this type of Cushing syndrome.

Joseph K. Belanoff: This quarter, we will start a Phase III study of Brella-Covalent in patients whose Cushing syndrome is caused by an adrenal adenoma or adrenal hyperplasia. The study is called Gradient, G-R-A-D-I-E-N-T. It will be the first randomized, double-blind, placebo-controlled trial in patients with this etiology of Cushing's. Gradient has planned enrollment of 130 patients at 60 sites in the United States and Europe. Participants will receive either Relaquarelent or placebo for six months, with the primary endpoints being improvements in glucose metabolism and hypertension. Many of the investigators for Grace will also participate in Grady.

Our postal person presentation of gradients design is available at the research and pipeline Slash publications tab of our website. An abstract is also available on the people may supplemental issue of the journal Endocrine Society.

I'll now turn to oncology program, which is examining three potential mechanisms by which cortisol modulation may benefit patients.

Cortisol activity suppresses pop ptosis programmed cell death chemotherapy is meant to cause tumors that express the G. R.

We are cats testing, whether adding our selective cortisol modulator reliv closer to chemotherapy blood cortisols anti apoptotic effect, thereby allowing chemotherapy to achieve its full cancer, killing potential.

Our goal is to confirmed the striking data we presented at ASCO last year, where are you ported results from our open label trial umbrella Dcor like plus Nab Paclitaxel celgenes chemotherapy drugs abraxane.

Joseph K. Belanoff: Green is part of our investment in the development of Brella Chloraline to treat patients with hyperchorizalism. It is not a required part of Brella Chloraline's NDA. Our goal is simply to help inform and improve the treatment of patients with this type of Cushing's syndrome. Our post-presentation of Gradients Design is available at the Research and Pipeline slash Publications tab of our website.

And our study seven at 25 patients with metastatic pancreatic cancer and fiber 11 patients with advanced ovarian cancer and she durable disease control, meaning their tumors, either shrank or see scrolling for 16 weeks for longer.

Joseph K. Belanoff: An abstract is also available in the April-May Supplemental Issue of the Journal of the Endocrine Society. I will now turn to our oncology program, which is examining three potential mechanisms by which cortisol modulation may benefit patients. Cortisol activity suppresses apoptosis, the programmed cell death chemotherapy is meant to cause, and tumors that express the GR. We are testing whether adding our selected cortisol modulator, Relochorlin, to chemotherapy will blunt cortisol's anti-apoptotic effect, thereby allowing chemotherapy to achieve its full cancer-killing potential. Our goal is to confirm the striking data we presented at ASCO last year, where we reported results from our open-label trial of Relacorlin plus Napaclitaxel, a cell genes chemotherapy drug called Abraxas. In our study, 7 of 25 patients with metastatic pancreatic cancer and 5 of 11 patients with advanced ovarian cancer achieved durable disease control, meaning their tumors either shrank or ceased growing for 16 weeks or longer. The duration of benefit in some patients was ike. For example, two patients with metastatic pancreatic cancer exhibited tumor shrinkage for more than 50 weeks.

The duration of benefiting some patients was eye catching.

Two patients with metastatic pancreatic cancer exuberant exhibited tumor shrinkage for more than 50 weeks.

One patient with ovarian cancer exhibited tumor shrinkage for 65 weeks.

The tumors in all obese patients have progressed during multiple lines of prior therapy, including therapy with Taxanes a poster presentation of these results is available at the Investor slashed past events tab of our website.

Last year, we began a controlled phase two trial umbrella core like plus Nab paclitaxel in patients with metastatic ovarian cancer with a plan enrollment of 180 patients at 25 sites in the United States and Europe.

The primary endpoint is progression free survival secondary endpoints, including overall survival and duration of benefit.

Hi challenges arising from the Cobot 19 pandemic, we continue to expect results of this study during the first half of next year.

This quarter, we will start a phase three trial umbrella core Leds in combination with Nab paclitaxel in patients with metastatic pancreatic cancer.

He's with a dire prognosis.

This trial will be called reliant Ari.

Anti.

Well I will be an open label trial, which 80 patients receive relamorelin plus Nab paclitaxel with the primary endpoint being the objective response rate.

Yes by RECIST criteria.

Plant to perform an interim analysis of data from the first 40 patients. We believe sufficiently positive results could support accelerated approval well I. It will be conducted at 30 sites in the United States.

Joseph K. Belanoff: One patient with ovarian cancer exhibited tumor shrinkage for 65 weeks. The tumors in all of these patients progressed during multiple lines of prior therapy, including therapy with taxidermy. Our poster presentation of these results is available on the investors slash past events tab of our website. Last year, we began a controlled Phase II trial of Relocorrelant plus Napaclitaxel in patients with metastatic ovarian cancer with a planned enrollment of 180 patients at 25 sites in the United States and Europe. The primary endpoint is progression-free survival, with secondary endpoints including overall survival and duration of benefit. Despite challenges arising from the COVID-19 pandemic, we continue to expect results from this study during the first half of next year. This quarter, we will start a Phase III trial of Reliquarolent in combination with napaclitaxel in patients with metastatic pancreatic cancer, a disease with a dire prognosis.

Cortisol modulation may also benefit patients like bolstering their immune response.

Cortisol is the Bodys natural Immunosuppressants. This effect is often beneficial it helps to prevent for example, auto immune disorders, such as rheumatoid arthritis.

In patients with cancer, However, cortisol activity suppresses the ability of the immune system to recognize and destroy tumor cells.

It also blends to cancer, killing attributes of Immunotherapeutic agents, such as checkpoint inhibitors.

Next quarter, we are starting an open label phase one be trial umbrella Carlin plus the PD, one checkpoint inhibitor Pembrolizumab merck's drug Keytruda 20 patients with metastatic or Unresectable adrenocortical cancer.

Because they're tumors produce cortisol. These patients also have Cushing syndrome, which cortisol modulation can treat.

Joseph K. Belanoff: This trial will be called Reliant, R-E-L-I-A-N-T. Reliant will be an open-label trial in which 80 patients receive Relacorlin plus NAP Paclitaxel with the primary endpoint being the objective response rate. Assessed by the RESIST Criterion, We plan to perform an interim analysis on data from the first 40 patients. We believe sufficiently positive results could support accelerated approval. Reliant will be conducted at 30 sites in the United States.

Our trial will examine whether were reliv Carla can in addition to treating Cushing syndrome in these patients specifically help immunotherapy achieve its maximum effect.

Reducing the immunosuppressive effects of excess cortisol activity.

Finally, cortisol modulation may benefit patients with castration resistant prostate cancer.

Androgen stimulates the growth of prostate tumors, which is why androgen receptor antagonists and with medications such as Enzalutamide side Pfizer's aggregate Sandy our standard therapy.

Joseph K. Belanoff: Cortisol modulation may also benefit patients by bolstering their immune response. Portisol is the body's natural immunosuppressant, and this effect is often beneficial.

More recently researchers at the University of Chicago, and Sloan Kettering have shown that when colonies of prostate cancer cells are exposed to institute of my greatest stimulated by cortisol activity at the G. R.

Joseph K. Belanoff: It helps to prevent, for example, autoimmune disorders such as rheumatoid arthritis. In patients with cancer, however, cortisol activity suppresses the ability of the immune system to recognize and destroy tumor cells. It also blunts the cancer-killing attributes of immunotherapeutic agents such as checkpoint inhibitors. Next quarter, we are starting an open-label Phase 1b trial of Relacorlin plus the PD-1 checkpoint inhibitor Pembrolizumab, Merck's drug Keytruda, in 20 patients with metastatic or unresectable adrenal cortical cancer. Because their tumors produce cortisol, these patients also have Cushing syndrome, which cortisol modulation can treat. Our trial will examine whether relucoriline can, in addition to treating Cushing syndrome in these patients, specifically help immunotherapy achieve its maximum effect by reducing the immunosuppressive effects of excess cortisol activity. Finally, cortisol modulation may benefit patients with castration-resistant prostate cancer. Androgen stimulates the growth of prostate tumors, which is why androgen receptor antagonism with medications such as enzalutamide, Pfizer's drug Xtandi, are standard therapies.

Our hypothesis is that a regimen, combining a cortisol modulator within androgen receptor antagonists block this tumor skate route.

Our selective cortisol modulator exa cartilage is putting in animal models of castration resistant prostate cancer.

By the end of this year, we expect to select the optimum dose of extra core Leds in combination with Enzalutamide side to bring forward in a controlled phase two trial.

In addition, a dose finding trial umbrella correlate plus enzalutamide side is being conducted by investigators at the University of Chicago.

I will conclude with an update of our program in metabolic disorders.

As many of you know we are developing our selective cortisol modulator miracle our lunch for the treatment of antipsychotic induced weight gain and non alcoholic Seattle hepatitis or Nash.

Millions of patients rely on medications, such as a lance appealing to treat diseases, such as schizophrenia and bipolar disorder.

Fortunately these drugs plus serious met about balk abnormalities, including rapid gate weight gain and Olympic disorders, and nearly everyone who takes them.

Patients are forced to make a terrible bargain create one dangerous disease, but at the cost of acquiring another.

Heart disease, and stroke not suicide, a leading causes of death in patients taking anti psychotic medications.

Joseph K. Belanoff: More recently, researchers at the University of Chicago in Sloan-Kettering have shown that when colonies of prosper cancer cells are exposed to enzalutamide, growth is stimulated by cortisol activity at the GR. Our hypothesis is that a regimen combining a cortisol modulator with an androgen receptor antagonist will block this tumor escape route. Our selective cortisol modulator, hexachloroate, is potent in animal models of castration-resistant prostate cancer. By the end of this year, we expect to select the optimum dose of hexachloroalant in combination with enzalutamide to bring forward in a controlled Phase II trial. In addition, a dose-finding trial of rolocorrelant plus enzalutamide is being conducted by investigators at the University of Chicago. I will conclude with an update of our program in metabolic disorders.

We can docket to double blind placebo controlled trials in healthy subjects, which made the kristen reduced weight gain caused by taking a lance appeal or respect for them.

Our results were published in the journals advances in therapy and obesity.

Unfortunately, we could not advancement for pursuing further for this indication because we took listings quality has the board of fashion disqualify it as a treatment for common disorders.

The other coral and can be advance because sort of selective cortisol modulator with no affinity for PR. It is not the abortion pill and if oppose it could be widely distributed.

Our core and one is more effective and get the Chris down in animal models of anti psychotic induced weight gain.

No I completed double blind placebo controlled phase one be study in healthy human subjects as demonstrated that New York Orland is active in reducing anti psychotic induced weight gain in humans.

And the first part of our phase one be trial 66 healthy subjects received elanzapine any their 600 milligrams of never correlate or placebo for 14 days.

Joseph K. Belanoff: As many of you know, we are developing our Selective Cortisol Modulator, Miracorlant, for the treatment of antipsychotic-induced weight gain and non-alcoholic steatohepatitis, or NAS. Millions of patients rely on medications such as olanzapine to treat diseases such as schizophrenia and bipolar disorder. Unfortunately, these drugs cause serious metabolic abnormalities, including rapid weight gain and lipid disorders, and nearly everyone who takes them. Patients are forced to make a terrible bargain, treat one dangerous disease but at the cost of acquiring another. Heart disease and stroke, not suicide, are the leading causes of death in patients taking antipsychotic medication.

Participants, who received nearly equivalent getting less weight than those who received well see though in addition, liver enzymes markers of liver damage increase the lesson patients who received mirror correlate suggesting that mirror coil. It has protective effects in the liver.

The second part of our trial 30 healthy subjects received landscaping any the mirror corlanor at 900 milligrams or placebo for 14 days the results confirm or findings from the first part of the study patients receiving near a coil and getting less weight, a lower triglycerides and had less sharply elevated liver enzymes and subject to receipt, let's see.

Though.

No side effects other those commonly seen with Elanzapine, we're seeing with either dose of New York World Stock, We plan to investigate considerably higher levels, a miracle neural equivalent exposures in future studies.

Joseph K. Belanoff: We conducted two double-blind placebo-controlled trials in healthy subjects in which mithopristone reduced weight gain caused by taking olanzapine or risperidone. Our results were published in the journals Advances in Therapy and Obesity. Unfortunately, we could not advance Mifepristine further for this indication because its quality as an abortifacient disqualifies it as a treatment for common disorders. Miracorlin can be advanced because it is a selective cortisol modulator with no affinity for the PR. It is not an abortion pill and, if approved, could be widely distributed.

The full results of our phase one be study will be published later this year.

Our double blind placebo controlled phase two trial of New York wireless called gratitude to reverse recent anti psychotic induced weight gain is in progress.

In this study 100 patients with schizophrenia, we'll continue to receive their established as an anti psychotic medication and either 600 milligrams of New York warlike or placebo for 12 weeks gratitude will be conducted an approximately 20 centers across the United States, while the cobot 19 pandemic us effectively suspended new enrollment.

In this trial, we're confident enrollment will resume as public health restrictions he's.

Joseph K. Belanoff: Maracoron is more effective than nifepristone in animal models of antipsychotic-induced weight gain. And now, our completed double-blind placebo-controlled Phase 1b study in healthy human subjects has demonstrated that miracorlin is active in reducing antipsychotic-induced weight gain in humans. In the first part of our Phase 1b trial, 66 healthy subjects received lansipine and either 600mg of niracoraline or placebo for 14 days. Participants who receive miracloralin gain less weight than those who receive placebo. In addition, liver enzymes, markers of liver damage, increase less in patients who receive miracloralin, suggesting that miracloralin has protective effects in the liver. In the second part of our trial, 30 healthy subjects received lansipine and either miracorlin at 900mg or placebo for 14 days. The results confirm our findings from the first part of the study. Patients receiving miriquerulin gained less weight, had lower triglycerides, and had less sharply elevated liver enzymes than subjects who received placebo. No side effects, other than those commonly seen with olanzapine, were seen with either dose of Miraquil.

There's been no delay in our plans to start by year end, a placebo controlled double blind phase two trial in patients with longstanding anti psychotic induced weight gain.

In this trial, we plan to test the formulation of Miracle are left that we believe will be achieved significantly higher exposures mirror correlate it will be reaching the gratitude trial, which again is examining the reversal of recent anti psychotic induced weight gain.

Finally in the first quarter of next year, we plan to start a double blind placebo controlled phase two trial, a miracle Ireland in patients with Nash serious liver disorder that affects millions of patients.

In animal models nearer Carla prevention reverses, both fatty liver liver fibrosis, which are precursors of Nash.

We also intend to test our new more potent formulation of mirror Korlym in this study.

In conclusion of course that had an outstanding with first quarter revenue and profits.

We increased our balance of cash in investments to $349 million, we have no debt.

Colgate 19th pandemic has slowed enrollment and site activation in Grace I pivotal phase three trial relic correlate to treat patients with Cushing syndrome.

We now plan to file or India, and the second quarter of Twentytwenty too.

Two quarters later than we had originally planned.

We now expect to start gradient, our phase three trial for all coil and patients with the Greenhill Cushing syndrome this quarter.

Joseph K. Belanoff: In fact, we plan to investigate considerably higher levels of neurocorrelant exposures in future studies. The full results of our Phase 1B study will be published later this year. Our double-blind, placebo-controlled Phase 2 trial of Miraclorelant, called Gratitude, to reverse recent antipsychotic-induced weight gain is in progress. In the study, 100 patients with schizophrenia will continue to receive their established dose of antipsychotic medication and either 600 milligrams of Miraclorelant or placebo for 12 weeks. Gratitude will be conducted in approximately 20 centers across the United States. While the COVID-19 pandemic has effectively suspended new enrollment in this trial, we are confident that enrollment will resume. Public Health Restrictions

We expect to we continue to expect results of our controlled phase two trial umbrella Carlin plus Nab paclitaxel to treat patients with metastatic ovarian cancer in the first half of next year.

This quarter, we plan to startup phase three trial called reliance umbrella, Carla plus Nab paclitaxel in patients with metastatic pancreatic cancer.

The leap sufficiently positive results in reliant will support accelerated approval.

Next quarter, we plan to start an open label phase one be study.

Relic world when combined with PD, one check inhibitor pembro lists a bad to treat patients with metastatic or unresectable renal cancer.

Finally by the end of this year, we expect to select suitable bird advancement of exit wireless in combination with enzalutamide to treat patients with castration resistant prostate cancer.

The second part of our phase one be trials mirror coral and to reduce weight gain caused by Lance gain has confirmed our earlier positive results.

Joseph K. Belanoff: There has been no delay in our plans to start, by year-end, a placebo-controlled, double-blind Phase II trial in patients with long-standing antipsychotic-induced weight gain. In this trial, we plan to test a formulation of miraclorelant that we believe will achieve significantly higher exposures of miraclorelant than will be reached in the GRATITUDE trial, which again is examining the reversal of recent anti Finally, in the first quarter of next year, we plan to start a double-blind, placebo-controlled Phase II trial of miroquailant in patients with NAS, a serious liver disorder that afflicts millions of patients. In animal models, niracloralin prevents and reverses both fatty liver and liver fibrosis, which are precursors of NASH. We also intend to test our new, more potent formulation, mirror-correlant, in this study. In conclusion, Corcept had an outstanding first quarter revenue and profit. We increased our balance of cash and investments to $349 million. We have no debt.

Double blind placebo controlled phase two trial Miracle wireless to reduce recent anti psychotic induced weight gain is open we expect enrollment to resume as public health restrictions loosen.

We plan to start a phase two trial Americorp, Ireland in patients with longstanding anti psychotic induced weight gain by year end as originally planned using it and improve formulation mirror correlate.

We now plan to startup phase two trial Miracle Gro Miro Korlym in patients with Nash in the first quarter of next year I'll stop here for questions.

Thank you at this time, if you do have a question. Please send off by pressing star one I can that well be someone for questions. We'll hear first today from Charles Duncan with Cantor Fitzgerald.

Hi, guys.

Hopefully you can hear being congratulations on a very good corridor and the reason I P uptake.

We'll go.

Thank you Charles.

Okay could you couldn't hear me I'm, not saying [laughter].

[noise] had a couple of questions from on the Korlym side, and then and then the pipeline you had a ton of things going on in the pipeline and I'm interested to explore that first before I do let me ask you a question on the commercial side with regard to the revenue.

Joseph K. Belanoff: The COVID-19 pandemic has slowed enrollment and site activation in GRACE, our pivotal phase three trial of relacorlin to treat patients with Cushing syndrome. We now plan to file our NDA in the second quarter of 2022, two quarters later than we had originally planned. We now expect to start Gradient, our Phase 3 trial of thrella coil in patients with Adrenal Cushing Syndrome this quarter. We also continue to expect results of our controlled phase two trial of roacloraline plus napaclitaxel to treat patients with metastatic ovarian cancer in the first half of next year. This quarter, we plan to start a phase 3 trial called Reliant of Revocorrelant plus Nabpaclipaxil in patients with metastatic pancreatic cancer. We believe sufficiently positive results and Reliant will support accelerated approval.

Growth that you saw could you help us understand better the contribution of demand.

Versus say pricing <unk> dose Uh huh.

Corridor.

Sure H. as this is Charlie I I'll answer that question. So just a little background for folks traditionally or historically every every first quarter, we face a headwind our revenue faces a headwind due to a couple of factors primarily the annual reauthorization price.

So that's that insurers put their patients through which results in patients receiving it be certain being essentially the reinsurance being suspended we work through those issues and providing a threed free drug in the meantime, and then get them back on paid drug, but our revenue takes a hit in the first quarter every year as well.

Joseph K. Belanoff: Next quarter, we plan to start an open-label, Phase 1b study of Rilocoralin combined with the PD-1 check inhibitor Pembrolizumab to treat patients with metastatic or unresectable adrenal cancer. Finally, by the end of this year, we expect to select a dose suitable for advancement of hexaquareline in combination with indolutamide to treat patients with castration-resistant prostate cancer. The second part of our Phase 1b trial of Miracloraline to reduce weight gain caused by lansipine has confirmed our earlier positive results. A double-blind, placebo-controlled Phase 2 trial of Miraquarelid to reduce recent antipsychotic-induced weight gain is open. We expect enrollment to resume as public health restrictions loosen. We plan to start a Phase II trial of Miracoraline in patients with long-standing antipsychotic-induced weight gain by year-end, as originally planned, using an improved formulation of Miracoraline. We now plan to start our Phase II trial of miracloralant in patients with NASH in the first quarter of next year. I'll stop here for questions.

Deal with that administrative hurdle also.

I'm in the first quarter.

Virtually all of our Medicare patients go through the Medicare Donut hole, which is a which we are obligated to cover about three quarters of that cost. So that is a nother deduction to our revenue and so as a result sort of absent a price increase our first quarter is typically flat or even down a little bit in terms of.

So so with that as sort of background I can tell you. We took a 5% revenue increase at the start of the year that I think had the effect of.

The most part kind of counterbalancing that that headwind. Okay. So that was the effect of a change in price now the rest of the growth I think roughly speaking think of it. It's about there were sort of two factors at play one.

Is that [noise].

Insurance companies allowed patients some insurance companies allowed patients to rebuild their prescription just a few days earlier than normal the thinking was in case there are logistical deferred difficulties posed by the pandemic and they federal express can't deliver on time.

Operator: Thank you. At this time, if you do have a question, please signal us by pressing star 1. Again, that will be star 1 for questions.

One patients to run out of medicine, So a very small minority of our patients received refills a few days earlier than they normally would actually that's about half of the growth that you saw in the quarter roughly the other half a was due to improved.

Charles Duncan: We'll hear first today from Charles Duncan with Cantor Fitzgerald. Hi, guys. Let's see, hopefully you can hear me. Congratulations on a very good quarter and the recent IP update, Charlie and Joe. Thank you, Charles.

Patient adherence patients just took their medicine more regularly than they normally do and I described that's certainly a pandemic conditions, but I think that's sort of medical fact that perhaps Joe would you like to elaborate on at all yeah, I think that and that's I think everybody knows including myself patients don't always take.

Charles Duncan: Charles. Yeah.

Unknown Speaker: Okay, good. You can hear me.

Charles Duncan: Let's see. I have a couple of questions on the Coralim side and then the pipeline. You've got a ton of things going on in the pipeline, and I'm interested to explore that. But first, before I do, let me ask you a question on the commercial side. With regard to the revenue growth that you saw, could you help us understand better the contribution of demand versus, say, pricing and or dose in the quarter?

They're medicine everyday even when they're supposed to and there are some medications that they take you know sometimes only half the time jobs. So it's not what their doctors and 10, that's not really true it called them patients do take them medicine pretty much on schedule, but still days our missed we saw very little of that in this quarter because.

Gary Charles Robb: Sure. Hey Chas, this is Charlie.

Gary Charles Robb: I'll answer that question. So, just a little background for folks. Traditionally, and historically, every first quarter, we face a headwind. Our revenue faces a headwind due to a couple of factors. Primarily, the annual reauthorization process that insurers put their patients through, which results in patients receiving, essentially, their insurance being suspended. We work through those issues and provide them with free drugs in the meantime, and then get them back on paid drugs. But our revenue takes a hit in the first quarter every year as we deal with that administrative hurdle. In the first quarter, virtually all of our Medicare patients go through the Medicare donut hole, of which we are obligated to cover about three-quarters of that cost. So that is another deduction to our revenue. And so, as a result, sort of absent a price increase, our first quarter is typically flat or even down a little bit in terms of revenue.

Cause I think that patients with Cushing syndrome.

Understand their doctors, helping them understand if they are particularly high risk for inception, and frankly, the fear of the contracting cobot 19, I think attitude that adherence percentage now for us as a company. Obviously, we think that that's a very important benefit for patients and we hope to really maintain that idea that this.

Medication that is best taking every single day that is prescribed as we go forward.

Okay. That's helpful Charlie Joe.

And given those dynamics could you provide to any granularity on say new patient you know you mean diagnoses new new scripts.

In the quarter 'cause it Charlie mentioned adherents so what about.

Any additional patients.

Well you know that basically starting in March virtually every medical practice in the country shut downs visits from medical site personal visits by medical science liaisons for clinical specialists and I thought our commercial team really did a terrific job and instantly adopting the idea that there were.

Gary Charles Robb: So with that as sort of background, I can tell you we took a 5% revenue increase at, For the most part, you know, kind of counterbalancing that, that headwind. Douglas Goldstein, CFP®, is the director of Profile Investment Services and the host, So insurance companies allowed patients, some insurance companies allowed patients to refill their prescription just a few days earlier than normal. I think the thinking was in case there are logistical difficulties posed by the pandemic and the Federal Express can't deliver on time, they didn't want patients to run out of medicine. So a very small minority of our patients received refills a few days earlier than they normally would. So that's about half of the growth that you saw in the quarter. Roughly the other half was due to improved patient adherence. Patients just took their medicine more regularly than they normally do and I'd describe that to certain pandemic conditions. But I think that's sort of a medical fact that perhaps, Joe, would you like to elaborate on at all? Yeah.

Doctors, who were still interested in being reach but needed to be read reached remotely we were still even able to conduct a.

You know various events, where doctors could gain more information remotely and it really interesting thing I think is that there are so you know mainly a small minority doctors, who I think because of their own practices, and perhaps and real personalities actually seem to favor. This remote contact as opposed to the standard inpatient caught that now on balance of course.

That's not the case I think that its difficult for patients to get to the Doctor right now diagnosing Cushing syndrome involves a lot of testing.

Joseph K. Belanoff: As I think everybody knows, including myself, patients don't always take their medicine every day, even when they're supposed to, and there are some medications that they take sometimes only half the time, which obviously is not what their doctors intend. That's not really true with coelom. Patients do take their medicine pretty much on schedule, but still, days are missed. We saw very little of that in this quarter because I think that patients with Cushing Syndrome understand, and their doctors help them understand, that they are particularly at risk for infections, and frankly, the fear of contracting COVID-19, I think, added to that adherence percentage. Now, for us as a company, obviously, we think that that's a very important benefit for patients, and we hope to really maintain that idea that this is a medication that is best taken every single day that it's prescribed as we go forward.

Everyone knows all those sort of things that in the world that being said, we did see new enrollments.

In the quarter I'm not as many as we expect to see any restriction absent time, but Ah, but we did see new enrollments and we and we continue to see new enrollments and as I said, what we're really trying to do this at this point in time as learn all the things that this forced experiment forces you know really get forces to learn and incorporate than as we go forward.

[noise] things loosen up.

Okay. That's helpful. Joe and then if I could move on to the.

Pipeline questions that I had particularly with regard to look Korlym and Grace timing I think you provided pretty good explanation on on the of the I'm kinda intent of coated 19 on that but could you provide us more information with regard to that number.

Gary Charles Robb: Okay, that's helpful, Charlie and Joe. And given those dynamics, could you provide any granularity on, say, a new patient, you know, new diagnoses, new scripts in the quarter? Because Charlie mentioned adherence. So what about any additional patients?

Patient center roles are actual numbers sites up and running and any other work needed for the N.D.A. in terms of say long term tax or manufacturing process C.

Joseph K. Belanoff: Well, as you know, basically, starting in March, virtually every medical practice in the country shut down visits for medical science, personal visits by medical science liaisons or clinical specialists. And I thought our commercial team really did a terrific job of instantly adopting the idea that there were some doctors who were still interested in being reached but needed to be reached remotely. We were still even able to conduct, you know, various events where doctors could gain more information remotely. And a really interesting thing, I think, is that there is, you know, admittedly a small minority of doctors who, I think, because of their own practices and perhaps their own personalities actually seem to favor this remote contact as opposed to the standard inpatient contact. Now, on balance, of course, that's not the case. I think that it's difficult for patients to get to the doctor right now because diagnosing Cushing Syndrome involves a lot of testing. Everyone knows all those sort of things that are in the world.

You know my optimization.

Yes, no I think I understand the question and let me just provide you more details.

One although the the addition of patients changes to the study basically you know slowed to a trickle or close to zero at some point I think it's important for everyone understand that the patients who were on trial continues to be seen by their physicians and so have march their way through <unk>.

Through the study.

Very interesting decision mean, primarily at academic centers, which are which I think you know what those their best compromise was that patients who were already receiving medicine in the study should continue to receive the medications and study, but they didn't really but everything else that was going on I want to add new patients to their case load at that point in time now we have.

Never actually giving specific numbers that we have but I think that you can add than you know up to understand sort of where we weren't take them to take your best estimate where it's going to end up Oh, we really do you feel confident at this point that it's when they can you give me just centrally at two quarter delayed really encompasses everything we need to get done but to your.

Joseph K. Belanoff: That being said, we did see new enrollments in the quarter. Not as many as we expect to see in a restriction-free time, but we did see new enrollments, and we continue to see new enrollments. And as I said, what we're really trying to do at this point in time is learn all the things that this forced experiment forces us to learn and incorporate.

Specific questions, yes, the long term toxicology continued at pace, that's not an issue that will actually be done on what was the standard timeline before a manufacturing issues are and fan and solutions moved along with their same pace. So really the limiting variable wasn't study.

Joseph K. Belanoff: Okay, that's helpful, Joe. And then I could move on to the pipeline questions that I had, particularly with regard to relacorlin and grace timing. I think you provided a pretty good explanation of the kind of impact of COVID-19 on that. But can you provide us more information with regard to the number of patients that are enrolled or the actual number of sites up and running and any other work needed for the NDA in terms of, say, long-term COPS or manufacturing processes?

Was already going to be the final efficacy and safety results and it's still going to be case.

That's helpful. Last question and then I'll hop back in the queue is relative to a you know your your broader platform you've got a lot of candidates in keeping the clinic or soon to be and I get some kind of wondering you've done it because medicinal chemistry for.

Joseph K. Belanoff: Yeah, no, I think I understand the question, and let me just provide a few more details. One, although the addition of patients to the study basically, you know, slowed to a trickle or close to zero at some points, I think it's important for everyone to understand that the patients who were on trial continued to be seen by their physicians and so made their way through the study. It was a very interesting decision, you know, primarily at academic centers, which I think was their best compromise was that patients who were already receiving medicine in the study should continue to receive the medicine in the study, but they didn't really, with everything else that was going on, want to add new patients to their caseload at that point in time.

Glucocorticoid receptor modulator game for awhile.

And when you consider the breadth of those efforts relative to other approaches each seed, perhaps even recently or in the past such as those by a recent IPO could you compare and contrast, your efforts versus others that have come along.

Oh, Yeah broadly I can't I mean, we thought for very long period of time and it was basically my my research career and down like like my career course or for the last 20 years that the cortisol modulation platform is an extremely important medical platform on many diseases are affected by.

Joseph K. Belanoff: Now, we have never actually given specific numbers that we have, but I think that you can add them up to understand sort of where we were, take your best estimate and where it's going to end up, and we really do feel confident at this point that the date that we've now given, which is essentially a two-quarter delay, really encompasses everything we need to get done. But to your specific question, yes, the long-term toxicology continued at pace. That's not an issue. That will actually be done on what was the standard timeline before. The underlying issues and solutions moved along at the same pace, so really, the limiting variable for this study was already going to be the final efficacy and safety results and is still going to be.

Cortisol activity.

And we really have follow the research to the places where we think they can be best served by treatments and we'll continue to do that we still have interesting programs that are even earlier in the pipeline because cortisol goes everywhere in the body and cortisol modulation really affects many many different diseases.

Chasses somebody who really as follows our research for very long time, you knew that one of the really limiting variables was the only drug which is available for cortisol modulation was missed the personnel, which by the activity has different receptor. The progesterone receptor had all of its really notoriety as the abortion pill for various.

Joseph K. Belanoff: That's helpful. The last question, and then I'll hop back in the queue, is relative to your broader platform; you've got a lot of candidates in the clinic or soon will. And I guess I'm kind of wondering, you've been at this medicinal chemistry for glucocorticoid receptor modulators game for a while. And when you consider the breadth of those efforts relative to other approaches you've seen, perhaps even recently or in the past, such as those by a recent IPO, could you compare and contrast your efforts versus others that have come along?

A long period of time.

Coil and it's an excellent drug for Cushing syndrome, but it is not as selected driving gifts to other receptors. Besides the.

Couric, one receptor it affects other hormones activity besides cortisol and also affects progesterone and to a lesser degree androgen words.

A modest androgen receptor antagonist on additional chemistry goal and many had tried it before we'd do it was to come up with a selective cortisol modulation girl drug, which did not touched the progesterone receptor and it was really or a real medicinal chemistry, she's not often.

On these calls because she's in England, our lead chemist head of research as a skilled to.

Joseph K. Belanoff: Yeah, broadly, I can. I mean, we thought for a very long period of time, and it was basically my research career and now my career at Corsair for the last 20 years, that the cortisol modulation platform was an extremely important medical platform. Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Cortisol goes everywhere in the body, and cortisol modulation really affects many, many different diseases. Now, Chad, as somebody who really has followed our research for a very long time, you knew that one of the really limiting variables was the only drug which was available for cortisol Quorum is an excellent drug for Cushing's syndrome, but it is not a popular drug.

Additional canvas by background need Hazel Hunt and she really put together the original ideas as to how you can create a compound which was a cortisol modulator, but did not get to me that progesterone receptor and ultimately was very very successful in doing that and arc and our compounds are really on a.

Profoundly selected for cortisol activity, you don't touched progesterone receptor at all I think that's really a Chris you know a critical difference between that and all the other compounds, which are out in the world at this point being developed he's going into our new other modulators or the modulators arent quite as selective as ours.

It gets in more than one receptor and I think that one of the really important I'll just I don't want to get to esoteric with us, but basically a selective cortisol modulator, which is a whirring structure steroids I think it's very difficult to come but it really took a novel structure, one with which would fit.

Joseph K. Belanoff: It gets to other receptors besides. Unknown Speaker, Unknown Attendee, Unknown Attendee, Unknown Attendee, Unknown Attendee, Our medicinal chemistry goal, and many had tried it before we did, was to come up with a selective cortisol-modulating drug, a drug which did not touch the progesterone receptor. And it was really a real medicinal chemistry feat. She's not often on these calls because she's in England.

The glucocorticoid receptor and not the progesterone receptor that really got us to selectivity, so I'll sort of leave it at that but I think that isn't major difference between our compounds and others.

That's very helpful shelf, taking all the question congrats on a good color.

Good good to talk to each S.

Well hear next from Casino <unk> with Bank of America.

Joseph K. Belanoff: Our lead chemist and head of research is a skilled doctor, a medicinal cannabis by background, named Hazel Hunt, and she really put together the original ideas as to how you could create a compound that was a cortisol modulator but did not get to the progesterone receptor. And ultimately, she was very, very successful in doing that, and our compounds are really profoundly selective for cortisol activity. They don't touch the progesterone receptor at all, and I think that's really a critical difference between that and all the other compounds which are out in the world at this point being developed; either there are no other modulators, or the modulators aren't quite as selective as ours; they really get to more than one receptor. And I think that one of the really important things, I don't want to get too esoteric with this, but basically a selective cortisol modulator, which is a four-ring structure, a steroid, is very difficult to come by. It really took a novel structure, one that would fit the glucocorticoid receptor and not the progesterone receptor, that really got us to selectivity. So I'll sort of leave it at that, but I think that is a major difference between our compounds and others.

Hello, Thanks for taking my question I think I'd hear me.

Oh, Yeah, we can't disease right.

Okay perfect lifestyle.

My follow up on the Warner and isolation for having a very strong number.

[laughter] talk about anytime soon.

I'm asking on it because based on a number that use.

Thank you it seems like the rest of the here it shouldn't be too difficult for you. So I haven't seen on your guidance.

Right. So just because it wasn't little hard to hear you to the I'm going to just repeat your question and make sure I got it right, which was what are we seeing in in April.

And what is that for you know sort of portend for that for the rest of the year given the results. We had in the first quarter and I guess I'd say that.

We'd given our we reaffirmed our guidance for the year and that's and we didn't know we don't give you don't give quarterly guidance or any kind of interim guidance, unless we think that needs to change and all I can say is that we looked at all of the you know the drivers of our revenue all the variables that we always look at we.

Adjusted them, a as we thought appropriate for the conditions, we saw and expect to see for the rest of the year and landed right back in the same plates and our revenue guidance that we gave originally so we reaffirmed it and that's really all the detail I can give you Joe do you want to add any.

Joseph K. Belanoff: It's very helpful. Thanks, Joe, for taking all the questions. Congratulations on a good call.

Joseph K. Belanoff: It's good to talk to you, Chas.

Tazeem Ahmad: We'll hear next from Tazeem Ahmad with Bank of America. Hello, thanks for taking my questions. Can you guys hear me?

Any detailed look I'll say, something which is obvious but work, stating, it's very tough to predict where things are going to be the rest of the year for anybody we really took our best crack at it we were very pleased to see how things went into first quarter. We don't know what things currently in place will you know <unk>.

Tazeem Ahmad: Yeah, we can, Suzeen. Hi.

Tazeem Ahmad: Okay, perfect. Hi Kelly. I do need to follow up on the quarter, and congratulations on having a very strong number. Specifically, can you talk about any trends that you've seen in April? And I'm asking only because, based on the number that you showed for 1Q, it seems like for the rest of the year, it shouldn't be too difficult for you to have a lead on your guidance.

With that and results will be or frankly, new things, which may come up as the year goes along so we really did our best to come down where we thought it was and and you've heard it I'm really don't have anything more to at at this point yeah.

Gary Charles Robb: Right, so just because it was a little hard to hear you because I'm going to just repeat your question and make sure I got it right, which was, you know, what are we seeing in April? And what is that for, you know, sort of portend for the rest of the year, given the results we had in the first quarter? And I guess I would say that Unknown Attendee, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, Gregory Fraser, Atabak Mokari, Swayampakula Ramakanth, Atabak Mokari,

So I guess based on what your thoughts for one key in which one of those things could token can get arrested here too. So you did a good dollars explaining that being fairly good that's about talking about.

So again, I think creep to offset some of the impact that you see every first quarter and that if I remember correctly from your earlier question and about half the remaining growth might have come from a small minority of patients.

They're script renewed a little bit early in anticipation of maybe not being able to to be as.

Gary Charles Robb: It's very tough to predict where things are going to be.

Gary Charles Robb: Unknown Attendee, Swayampakula Ramakanth, Gary Robb, Joseph Belanoff, Gregory Fraser

A quarter Golden they can't get around it easily would you see that for example, as something that will continue the rest for the year.

Gary Charles Robb: So I guess based on what you saw for 1Q, which one of those things could still continue the rest of the year? So you did a good job of explaining, I think Charlie did this, about talking about the 5% price increase to offset some of the impact that you see every first quarter. And that, if I remember correctly from the earlier question, about half of the remaining growth might have come from a small minority of patients getting their scripts renewed a little bit early in anticipation of maybe not being able to be as portable, meaning they can't get around as easily. Would you see that, for example, as something that would continue for the rest of the year?

Yeah, well, what we've seen this is again I'll just repeat it. So you get some you know for example, the insurance companies, allowing patients to refill their prescriptions a few days earlier do we see that continuing.

I think this that's something that we have seen continued so far but you know again, we insurance companies don't tell us their plans and so we kind of took our best stab at how we thought it would be able to the rest of year, but you know our crystal ball in that regard is really know better than anyone else's.

And that's yeah, I, just can't speak with any more certainty than that.

Gary Charles Robb: Well, what we've seen, this is, again, I'll just repeat it, so you get to, you know, for example, the insurance companies allowing patients to refill their prescriptions a few days earlier. Do we see that continuing? I think that's something that we have seen continued so far, but, you know, again, the insurance companies don't tell us their plans, and so we kind of took our best stab at how we thought it would behave over the rest of the year, but, you know, our crystal ball in that regard is really no better than anyone else's, and that's, you know, I just can't speak with any more certainty than that.

And since you know just sat on the second point that it's really.

That's a good thing for patients to take their medicine every day, and we're really working hard to get that message out there, particularly in this time, where they are a greater risk exactly what it's going to mean you know as time goes along I don't know, but its a very important medical thing and we hope that it continues.

Okay Fair enough and then my last one for me I could squeeze and then it's how are you thinking about the deltaport increase that you've been planning that could be a thing is that could have impact starting in the second happening here.

Yeah.

Well.

Joseph K. Belanoff: And to add to the second point, it's really important for patients to take their medicine every day, and we're really working hard to get that message out there, particularly in this time when they are at greater risk. Exactly what it's going to mean as time goes along, I don't know, but it's a very important medical thing, and we hope that it continues.

Yes.

Thanks, because it seems like a distant time before thinking about that yes, we've we've actually filled out ourselves for US you know to some degree a unfortunately some of them to come on freshly as this began and well using this time to for them to go to even a graduate school because we always teacher.

Gary Charles Robb: 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.

Our our clinical specialists a lot and this has really been an opportunity for them to have you done more in depth training and we've really done that which I I give our training staff a lot of credit for the how its going you know they will they'll come on line has things loosen up overtime, and we're hoping they're going to make a substantial contribution but time will tell.

Yeah.

Okay. Thank you Macquarie talk about quality.

Joseph K. Belanoff: That But yes, we've actually filled out our sales force to some degree. Unfortunately, some of them had come on fresh as this began, and we're using this time for them to go to graduate school. Because we always teach our clinical specialists a lot, and this has really been an opportunity for them to have even more in-depth training, and we've really done that, which I give our training staff a lot of credit for. They will now come online as things loosen up over time, and we're hoping they're going to make a substantial contribution, but time will tell.

Oh no problems all right good area.

And from Ladenburg Thalmann, What's your next from Matt Kaplan.

Hey, guys Congrats nice quarter.

Just I guess question for Charlie just wanted to dig in a little bit.

To <unk> legal standpoint.

Thanks.

Next we update.

Thanks.

Parts could we see this year with respect that have a dispute Israel. The situation, where you just just wait for the the trial to occur next February or what what what should the let's use along this year.

Tazeem Ahmad: Okay, thank you. I'm sorry about the bad quality.

Yeah. So I think with respect to our you know sort of dispute with seven so both the district court a lawsuit and the the patent office up post Grant review proceeding that we have underway I think that there's really.

Tazeem Ahmad: No, no problem. All right.

Matthew Lee Kaplan: And from Ladenburg-Solomon, we'll hear next from Matt Kaplan. Hey guys, congrats on a nice quarter.

Matthew Lee Kaplan: Just, I guess, question for Charlie, just wanted to dig in a little bit to, from a legal standpoint, thanks for the update. What events or what moving parts could we see this year with respect to the Teva dispute? Is it a situation where we just wait for the trial to occur next February, or what should go on this year?

The the things to look for frankly are the ruling from the P. tab in November on the post Grant review I mean, you will be used exchanging some legal briefs with Teva, which I think will be a matter of public record of the patent office and then you can just go to the public records and let them up as their fee.

Gary Charles Robb: Yeah, so with respect to our sort of disputes with TEVA, so both the district court lawsuit and the Patent Office post-grant review proceeding that we have underway, I think that there's really only one thing to look forward to, frankly, is the ruling from the PTAB in November on the post-grant review. I mean, we will be exchanging some legal briefs with TEVA, which I think will be a matter of public record at the Patent Office, but I think you can just go to the public records and look them up as they're filed. And then, you know, after that, we'll have our hearing, and then they will issue a decision. So I think, really, the November decision from the Patent Office and really nothing of sort of public note until the trial with TEVA in February.

While.

And then after that we'll have our hearing and then they will issue a decision. So I think really the November decision from the patent office and really are not nothing of sort of public notes into the trial with Teva in February.

Okay. Okay.

That's helpful. Thanks, there actually yet.

And I guess, a quick question comes down in terms of pipeline and help you have to think about.

Studies that you now plan to.

To start haven't gone starting in college expects you got specifically in pancreatic cancer when should we expect potential that results from that study as you get them the right this quarter, but basically.

Joseph K. Belanoff: Okay, okay, that's helpful, thanks for the detail. And I guess a question for Joe in terms of pipeline and helping us think about the studies that you have a plan to start, have ongoing plans to start in the oncology space. I guess specifically in pancreatic cancer, when should we expect potential results from that study as you get underway this quarter, phase three?

You know with the caviar that.

We never really know what the pace of studies are gonna be and are going to be till we'd been getting them.

I think that you actually and this is really the true forward looking statements to take it in that context and no more than that because we haven't even begun. This study I think that we will be at a point, where we will have results on the first half of the study about a year after it begins.

Joseph K. Belanoff: With the caveat that we never really know what the pace of studies is going to be until we begin them. You know, I think that you actually, and this is really a true forward-looking statement, so take it in that context, no more than that because we haven't even begun the study. I think that we will be at a point where we'll have results for the first half of the study about a year after it begins.

Okay very good and then in terms of Additionally, we've still got what's going on in oncology setting or I guess metastatic ovarian cancer study and ER and also the combination with PD ones in there.

Isn't that when when when do you think we should start to maybe you didn't want some time lines in there and when you exclude.

Joseph K. Belanoff: Okay, very good. And then, in terms of additional use of glucagon in the oncology setting, I guess the metastatic ovarian cancer study and also the combination with the PD, one in there kind of goes a nab. When do you think we should start to, maybe more on some timelines from there, when do you think we should see the results from those two studies?

So those those two studies.

I I heard the second what about the adrenal cancer study with Pembro wasn't that and what was the other study you asked me about not metastatic ovarian cancer study I guess that Oh, okay. Okay.

Eric.

Yeah. So let me let me just give a little bit of editorial comment. It's actually been interesting you know I think we said it in the press release, but not you know well all studies were affected by all being affected by this pandemic.

Joseph K. Belanoff: I heard the second one about the adrenal cancer study with Pembroke, was it not? And what was the other study you were asking about, Matt? A metastatic ovarian cancer study, I guess that's what it was. Oh, okay, okay.

They're not 100% being affected the same I think the oncology studies you know all diseases are bad, but you know oncology is some sense the tip of the iceberg, a bad and a lot of this patients have to end up going into hospital, regardless of where their care. So although the the piece of enrollment for instance, neo varying study very.

Joseph K. Belanoff: Metastatic ovarian cancer... So, let me just give a little bit of editorial comment. It's actually been interesting.

Cancer study has diminished it has not gone to zero and we still expect that we will have results in the same time table that we thought we would on previously which as you know for example next year.

Joseph K. Belanoff: I think we said it in a press release, but while all studies were affected by, are being affected by this pandemic, they're not 100% being affected the same way. I think the oncology studies are bad, but oncology is, in some sense, the tip of the iceberg of bad, and a lot of those patients have to end up going to the hospital regardless for their care. So although the pace of enrollment, for instance, in the ovarian cancer study has diminished, it has not gone to zero, and we still expect that we will have results on the same timetable that we thought we would previously, which is... As for the adrenal cancer study, we're very excited to get that started.

As for the adrenal cancer study very excited to get that started renal cancer, which we haven't talked much about is really a rare cancer.

Incidence rate is very low although it's very severe cancer. So well understood. We're really excited to get going in that because those patients already get treated with close to where their Cushing syndrome, we're really and as a second do do unfortunately poorly on.

There are currently so there's really good reason why a GR modulators cortisol modulator might have on the potential for success with these patients that I can tell you in animal models. It looks pretty good. So again it seems that study get started with the same caviar very forward looking statements studies and that storage yet I think there's 20 pace.

Joseph K. Belanoff: Adrenal cancer, which we haven't talked much about, is really a rare cancer since its rate is very low, although it's a very severe cancer and somewhat well understood. We're really excited to get going on that because those patients already get treated with Corleum for their Cushing syndrome. We're really, and second, due, unfortunately, poorly to immunotherapy currently. So there's really a good reason why a GR modulator, a cortisol modulator, might have the potential for success with these patients, and I can tell you, in animal models, it looks pretty good. So again, as soon as that study gets started with the same caveat, very forward-looking statement, study's not started yet, I think those 20 patients will produce results.

Vince will produce results in about a year.

Yeah. Thanks for taking my question.

And because no good to talk to you Matt.

Well hear next from Chris how are kind of with Jefferies.

Great. Thanks, so much for taking the questions in law for my congratulations on the successful quarters will.

Thank you.

Sure. Okay. So I guess maybe.

For the Cisco and off a trial if you could help us think about the operating expenses moving forward through the rest of the you know there's obviously some ideas that maybe starting but unclear to me specifically, what the trends or trajectory, we should expect scooter as GMI with maybe a dip.

Matthew Lee Kaplan: Thanks a lot for taking the questions. Unknown Speaker Yeah, no good.

And operating style with respect to give detail korlym.

Chris Howerton: Yeah, no good to talk to you, Matt. We'll hear next from Chris Howerton with Jeffrey.

Sure I think the.

Where are you to think about also starting with X gene a I mean the.

Chris Howerton: Hey, great. Thanks so much for taking the questions, and I will offer my congratulations on a successful quarter as well.

We have not had.

Had too late late anyone off because of the pandemic weve been able to yeah administer the business pretty smoothly, even at a distance, which it's not too surprising since you know living in the Bay area I know, there's a working from home and so forth is a pretty well established track. So we've been able to run the business.

Gary Charles Robb: Thank you, Chris. Sure. Okay, so I guess, maybe to start off, Charlie, if you could help us think about the operating expenses moving forward for the rest of the year. There's obviously some R&D that may be starting, but unclear to me specifically what the trends or trajectory we should expect for SG&A with maybe a different operating style with respect to detail and correlates.

Smoothly and and just historically, if you look back at our SGN, a it tends to be pretty flat over the course of the year. So well, yes, there will be some less spending on travel and entertainment as the you know is that into a pandemic restrictions east I wouldn't think that's gonna be particular.

Gary Charles Robb: Uh, sure. Um, I think the, uh, Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc. Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept, Unknown Attendee, Swayampakula Ramakanth, Gregory Fraser, Edward Nash, Unknown Attendee, Swayampakula Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept, While it is true that a slower pace of site activation and slower patient enrollment will reduce our R&D expenses, again, or spread study costs out over a longer period of time, again I think the cost of actually enrolling and caring for a patient in a study is just a part of the overall expense, so while it will reduce our spending a little bit, I mean R&D includes very significant expenditures on manufacturing work, CMC work, preclinical research that's just continuing, and so again while I think, you know, obviously the pressure will be downward, again I don't expect a material diminution in our R&D costs due to the pandemic either.

The material.

Difference and I I wouldn't spend too much time, we'll try to guesstimate what that reduction will be x. I don't think it's kind of living matter on the R&D side.

While it is true that a a slower pace of site activation and slower patient enrollment will reduce our R&D expenses again or spread study costs out over you know a longer period of time again, I think the cost of actually you know enrolling in caring for a patient and the studies.

Just a part of the overall expense and so while it does reduce our spending a little bit I mean R&D includes very significant expenditures on manufacturing work CMC work preclinical research that just continuing so again, we'll I think you know obviously the pressure will be downward.

And I don't expect a material diminishing in R&D costs due to the pins anemic either.

Okay.

Joseph K. Belanoff: Okay, okay. That's fair. All right. And then, you know, obviously, there's increased interest with respect to oncology platforms and GI antagonisms. So within your specific pipeline, maybe, Joe, you could describe for us the important differences between reliquorolant and exiquorolant and what kind of ideal settings might be for one or both of those.

So and then maybe I think obviously, there's a increase interest with respect to the oncology clinical ends in.

Yeah, Ryan Gilligan isn't so within your specific pipeline.

Maybe Joe you could describe for us the do important differences between rather korlyms and that's equivalent and what kind of the ideal settings might be on one or both of those.

Oh, that's it that that's an interesting question I'm. So thanks for letting me dressing to do that I really want to give you some context, which I don't think I really had a chance to provide in the past, which is just to be blunt about it a decade ago. When we were thinking about creating selective you know.

Joseph K. Belanoff: That's an interesting question. Thanks for letting me address it. To do that, I really want to give you some context, which I don't think I've really had a chance to provide in the past, which is, just to be blunt about it, a decade ago when we were thinking about creating selective, course, all modulators. Really, it was just, you know, in fact, the program was entitled, you know, Nicopristone without progesterone antagonism, because that's really all We wanted to have something that wasn't the abortion pill because of the medical side effects of progesterone antagonism, both in terminating pregnancy and all the other medical side effects. And many people had actually tried at that point to do it, and it was not an easy thing to do, but as I said before, Dr. Hunt actually was able to figure that out, and we were really on our way.

Cortisol modulators really it was just a you know we effect for the program was entitled the.

With a personnel without progesterone antagonism because that's really all we were going for we wanted to have something with wasn't the abortion pill, because you know the medical side effects of other progesterone antagonism, a bull and terminating pregnancy and all the other medical side effects and many people it actually tried at that point to deal.

And it wasn't not an easy thing to do but as I said mentioned before you know Dr. Han actually was able to figure that out and we were really on our way, but what was interesting about it was that she ultimately created for different series of compounds.

Joseph K. Belanoff: But what was interesting about it was that she ultimately created four different series of compounds, all of which were cortisol modulators, none of which touched progesterone. A really, very deep library. But, you know, initially, it was one compound we were looking for. The really interesting thing that happened was that when we started testing these compounds preclinically, all of them modulated cortisol, none of them touched the progesterone receptor, but they weren't identical. Some were better at preventing weight gain, some were better at creating insulin sensitivity, some got into the brain, some didn't get into the brain, and some were more potent in oncologic models than others, and some of them were more pot And so what really ended up happening, you know, because of that, and I think we understand another whole lecture we'll talk about offline if you're interested, but the bottom line was, I think we really understand the science of tissue selectivity that we didn't understand before, but the bottom line was that instead of creating just a single follow-on compound, it created four or five different compounds that might be specific for different disorders. While all of them might have We think it's even more potent than relachloroan, but we're also testing relachloroan through the investigator study that we've described.

All of which were cortisol modulators, none of which project touch progesterone, a really very deep libraries, but you know initially it was one compound we were looking for the really interesting thing that happened was that when we start testing. These compounds preclinically all of them modulating cortisol none of them touched.

The progesterone receptor, but they weren't identical some we're better at preventing weight gain some are better at creating insulin sensitivity. Some got into the brings some didn't get into the brain and some are more potent in oncologic models than others and some of them and more specific potent in specific oncologic models.

And so what are really ended up with happening you know because of that and I think we understand it's another whole lecture off we'll talk about offline if you're interested but the bottom line was because I think we really understand the science of the tissue selectivity that we didn't understand before but the bottom line was that instead of creating just a single follow on comp town.

Created four or five different compounds, which might be specific for different disorders, while all of that might have affects some of them had much more potent affects and as you know extra coil and in particular it happens to be great <unk> in the prostate cancer model Preclinically, we thought even more potent in rela coil and we're also testing will occur.

Following the investigator sites that we've described.

Got it okay. That's very helpful. Thank you Joe.

Joseph K. Belanoff: Okay, that's very helpful. Thank you, Joe. And I, you know, one, I hope this is a problem that you have to deal with. But, you know, when we think about Reliquorland in its mature stage, theoretically, could be applied to both Cushing syndrome and oncology. So strategically, how do you think about pricing and commercialization between those two settings?

And I you know.

And I hope this is a problem that you have to do and said you know what when we think about rather corn and in its mature stage theoretically could be applied to both.

Cushing syndrome, as well as oncology said strategically how do you think about pricing and commercialization between those two settings.

Joseph K. Belanoff: Well, I think that that's actually an easier one to bridge because I think that the cancers that we are talking about are really still orphan or small number cancers, not so different from the population that we see in Cushing syndrome. So again, without any kind of, again, sort of specific study of them, I don't think there's really a lot of price difference between those two.

Well I think that that's actually an easier one to bridge because I think that on the cancers that we are talking about are really still orphan or small number cancers, not so different than the population that we see in Cushing syndrome. So again without any kind of again sort of specific study of them I don't think there's really.

A lot of pricing difference between those two yeah that would be very different if we were introducing relative coral and for some mass market disease, where primary care pricing would be would be would sort of ruled the day. What's interesting is that near record Ireland. The drug with it we are developing for anti psychotic induced weight gain.

Joseph K. Belanoff: And that would be very different if we were introducing relucorolant because some mass market would sort of rule the day. What's interesting is that Miracoralant, the drug that we are developing for antipsychotic-induced weight gain and NASH, happens to be a very liver-specific drug. It's a very organ-specific drug and not a particularly good drug for Cushing syndrome. There are other things like, you probably heard the term CIRMs, estrogen modulators, which are very tissue-specific. Miracoralant is one as well, but it is not particularly effective in Cushing syndrome. It really is aimed at primary care disorders at a. Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc.

And and Nash happens to be a very liver specific drug is a very organ specific drug and not be particularly good drug for Cushing syndrome. There are other things like on that you've probably heard the term serms estrogen modulators, which are very specific you're a korlym is one.

As well it is not particularly affected in Cushing syndrome. It really is aimed at primary care disorders that a.

That's a standard primary care pricing, so not an issue for relic Orlando and mirror Korlym is different.

Chris Howerton: Okay. Okay. Well, that's very clear. Okay. Well, thank you. Thanks so much for taking the questions.

Okay, Okay, Oh, well, that's very cool, okay, well. Thank you and that's an interesting question Oh, Yeah, no good to talk to you Chris.

Unknown Speaker: Unknown Speaker...

Unknown Speaker: I will talk to you first. Yep.

Swayampakula Ramakanth: Yep, thank you. We'll move next to Swayampakula Ramakanth with H.C. Wainwright.

Yeah. Thanks.

Well go next to swim for cooler Ramakanth with H.C. Wainwright.

Oh RK side.

Swayampakula Ramakanth: Hello RK

Joseph K. Belanoff: Hi, how are you? Thank you for taking the time to answer my questions. Most of my questions on the commercial front of your story have already been asked, so I just want to explore a few of these studies with you. For example, On the gradient, which is a study in patients suffering from adrenal adenoma, which ends up causing Cushing's disease. So how big is this population and if the study that you're planning progresses as you expected to, what would be the timeline for the data and also for filing? Because this probably is going to come after-GRACE.

Hi, how are you.

Thank you for taking my questions.

Most of my questions on the commercial from Buffalo story.

So I just want to explore fuel studies.

With you.

And on the gradient.

This is a study.

In patients suffering from I do know I didn't know him a HM.

The agenda.

Causing.

Things disease, so, yes, how big this population and.

Yes, the study that youre signing progresses.

As.

As you expect it to what would be the the timeline for the data and so forth filing.

Because this problem is going to come towards degrees.

Yeah. So again, let me just give a little background.

Joseph K. Belanoff: Yeah, so again, let me just give a little background on this. It's been well understood for, you know, I guess as long as Cushing syndrome has been understood, that adrenal tumors can produce enough cortisol to really be symptomatic. What's been very interesting over the last 25 years is that with the advances in imaging, there have been more patients discovered who have had adrenal tumors that were producing cortisol but not at a high enough level to produce really florid symptoms but still to produce real symptoms that caused morbidity, symptoms related to glucose intolerance and hypertension and so forth. That's really become much better understood in the last 10 years. Now what's interesting about that is many of these patients never really got treated for their hypercortisolism. They were treated with seven different medications for seven different parts of their disease, but never with a really unifying diagnosis, and it's really been only in the last decade that that's true. An interest in really getting that right is important. Now, a couple of interesting things.

For for this it's well it's been well understood for you know I guess as long as Cushing syndrome has been understood that adrenal tumors can produce enough cortisol to really be symptomatic, what's been very interesting over the last 25 years is that with the advances in imaging they've been more patients discovered.

Who have had adrenal tumors that we're producing cortisol, but not at the high high enough level to produce really worth symptoms, but still to pursue to produce real symptoms that were caused morbidity symptoms relate it to glucose intolerance and hypertension and so forth that's really become much better understood.

Stood in the last 10 years now what's interesting about that as many of these patients never really got treated for their hyper cortisol isn't it gets treated seven different medications for seven different parts of their disease, but never with really the unifying diagnosis and it's really been only in the last decade, that's true.

Interest really getting that rises important now couple interesting things. These patients as a group tend to not have severe cases of Cushing syndrome, but they have real cases of Cushing syndrome and interesting thing from from Pharma study perspective is that this is a group of patients who can be study in a double blind fashion.

Joseph K. Belanoff: These patients, as a group, tend to not have severe cases of Cushing syndrome, but they have real cases of Cushing syndrome. An interesting thing from a study perspective is that this is a group of patients who can be studied in a double-blind fashion since many of them, at the current time, are not being treated for their hypercortisolism with an anti-cortisol agent at all. From an ethical point of view, they can be randomized to a cortisol-modulating treatment like ours, like Lelacoralin or placebo, and do the sort of standard, true double-blind study. But it's very difficult to do with people who have more profound Cushing syndrome because giving somebody a placebo is, frankly, unethical, and people are resistant to it because a placebo simply just doesn't work in that disease state Okay, now to your specific question. Yeah, it's still an orphan group. I mean, we don't know exactly how many people actually have Cushing syndrome caused by adrenal tumors.

And since many of them at the current time are not being treated for their hyper corals awesome with an anti cortisol agent at all but couldn't so so from an ethical point of years. They can be randomized to cortisol modulating treatment like ours like lower core Ireland or placebo and do the sort of standard true double blind study that's very good.

Tickled to do with people, who have more more profound cushing syndrome, because they're giving somebody a placebo frankly it is on ethical and people are was our resistant to it. This will see though you know simply just doesn't work in that disease state. Okay. Now to your specific question, yet still an orphan group I mean, we don't know exactly how many people acts.

Finally have Cushing syndrome caused by adrenal tumors, but and so the number really is unknown and we will find that out as you know basically over time, but it's not an insignificant group of people and it certainly could be as many people as currently are diagnosed with pituitary Cushing syndrome.

Joseph K. Belanoff: but

Joseph K. Belanoff: So the number really is unknown, and we will find that out basically over time, but it's not an insignificant group of people, and it certainly could be as many people as currently are diagnosed with Pituitary Cushing Syndrome.

Joseph K. Belanoff: Very much. Thanks.

Okay.

Okay regarding again, the gratitude study, which is the lawn and.

Joseph K. Belanoff: And regarding the gratitude study, which is the one about treating weight gain due to antipsychotic use. Yes. How similar is that study to phase 1B in terms of the study design, and if there are any differences, you know, what sort of differences are there?

Treating they can do the under psychotic is yes, how similar to that study to the phase one.

So the study design.

And.

Any differences and what sort of differences Oh.

Joseph K. Belanoff: Unknown Speaker Yeah. I understand the question and thanks for the opportunity to clarify this. So the phase one study, remember, is in normal healthy subjects. So these are people who are just volunteers, and they are given lansipine for two weeks with either placebo or miracloralant. And so they're not patients really at all.

Yeah.

I understand the question and thanks for the opportunity to clarify this so the phase one study remember you, saying normal healthy subjects. So these are people who are just volunteers.

And they are given a lance appealing for two weeks with either placebo or with mirror Cortland and so they're not patients really at all it's a phase one study and what we're really what we're really trying to find out is whether the medication mirror corlanor was active in reducing the effects that you quickly see with.

Joseph K. Belanoff: It's a phase one study, and what we're really trying to find out is whether the medication miracloralant is active in reducing the effects that you quickly see with miracloralant even in healthy patients. So in that sense, it's a phase one study where an important pharmacodynamic effect can be assessed. And we've told you in that kind of study, marijuana will look good, similar to what we saw with mifepristone many years ago. And the phase two studies are really quite different. They're inpatient.

There are a core Ireland, even in healthy people.

So it's in that sense, if phase one study, where an important <unk> pharmacodynamic effect can be assessed and we told you in that kind of study mirror coral of good you know similar to what we had seen with.

If a person on many years ago that the phase two studies are really quite different there in patients and there are the ones that we described the gratitude study in patients who have gained weight recently you know within the last six months as an outlier thing.

Joseph K. Belanoff: And there are, the one that we described, the Gratitude Study, is in patients who have gained weight recently, you know, within the last six months. It's an outlier thing, from taking one of these anti-psychotic medications. And the study is about reducing that. And those patients stay on their antipsychotic medication, having gained weight, then they're randomized to either miracloriline or placebo, and the study result is a reduction in weight, as well as looking at all the other metabolic variables which have already gone awry because of the use of the antipsychotic medication. So really, what we learned in the Phase I study was, and that's a big deal, this is a medication that is Now comes the real test of whether it works in patients who are actually being affected by the drug.

Taking one of these anti psychotic medication and this study is about reducing that weight and those patients stay on their anti psychotic medication, having game away then the randomized to eat a mirror coil and or placebo and the study result is a reduction in weight as well as looking at all the other met or metabolic variables.

Which have already gone awry because of the use of the anti psychotic medication. So really what we've learned in the phase. One study was that's a big deal. This is a medication which is active in an important mechanism now comes the real test of whether it works and patients who are actually being affected by the the disease.

I'm just a follow up on this in this study you have an endpoint.

Joseph K. Belanoff: And just to follow up on this, in this study, you have an end point, which is, at the end of 12 weeks, what is the, um, the, um... What is the weight gain that is not, I mean, where they really don't get the weight gain, which, from the standpoint of 12 weeks, is that good enough? Because these patients generally, you know, at www.swayampakula.com.

As.

End of 12 weeks, but what is the.

What is the weekend, but that's not I mean.

I really don't get delayed game.

I'm going to slow leap.

But or is that good enough because these patients.

Lilly you know.

Uh huh.

Well again, depending on.

How long does that those and sometimes some of decision to still try trading that those.

The busy boxes and things so I'm not I understand.

Since its but since those are the patient group in this study.

Joseph K. Belanoff: Those are the patient group in this study, on stable antipsychotics, so their dose is now binititrate. But their weight gain is recent, so they started on the medication in a relatively recent period of time so that the weight gain that they've seen can be assessed not just by staying home during the pandemic virus, during the coronavirus, but specifically due to the medication. And that's what we're really trying to suss out, whether that weight gain, which we think is a direct effect of the antipsychotic medication, can be reduced with our drug.

On stable anti psychotics of their doses now been titrated.

But there are waking his recent so they started on the medication in a relatively recent period of time, so that the weekend that they've seen can can be assess not by you know just staying home during the pandemic virus you know there in the Corona virus, but specifically due to the medication and that's what we're really trying to assess out whether that week.

In which we think it's a direct effect of the anti psychotic medication can be reduced with our drug.

Swayampakula Ramakanth: Okay. Thank you very much, Joe. Thanks. Oh, nice to talk to you.

Okay. Thank you I'm a joke things.

Nice to talk to your market.

Swayampakula Ramakanth: Oh, nice to talk to you, R.K.

And from Stifel. What's your next from Adam Walsh.

Swayampakula Ramakanth: And from Stiefel, we'll hear next from Adam Walsh. Hi, thanks for taking my questions. This is Adam, and I'm for Adam.

Hi, I'm stuck book between my question Vicki adamant harmful Adam.

Adam Walsh: One quick one. Hi, you know, two more. Hi. You know, two more studies. Have you seen any plug plug interactions between reticorin and abrexin in your clinic?

One quick.

You know two more.

Oh, you know tumor studies have usone drug drug interaction between throughout according to in terms of Brexit formed all clinical studies have to date.

Joseph K. Belanoff: Yes, there is a drug-drug interaction. When you use Reliquor, you need to use less Abraxane to get to the same plasma level of Abraxane, and that's due to the CYP3A4 interaction.

Yes, yes, there is a drug drug interaction when you when you use.

When you use rail acquired when you need to use less abraxane to get to the same plasma level of abraxane.

And I just due to the Sip three a four interaction.

To put this EDI I'd be a potential problem for the combo therapy.

Joseph K. Belanoff: Could this EI be a potential problem for the combination therapy of these two drugs?

Two drugs.

Joseph K. Belanoff: Well, I'm not sure what in the sense you mean a problem. I mean, people have to use less Braxane. So I guess whoever's making Braxane is going to make a little less money from it. But in terms of its actual medical effect, no, I think that that commonly you have to look at drug-drug interactions. And I think that that's really a portion of it. But as I said, no, we really had no issue, I think, with the investigators in the study having to account for that effect.

Well I'm not sure what what since you mean, a problem I mean people you have to use a less abraxane. So I guess whoever is making abraxane is going to make a little less money from it but in terms of its actual medical effect no. I think that that are commonly you have to look at drug drug interactions and I think that that's really a a portion of it but as I said.

At no we really had no issue I think with the investigators in the study having to account for that effect.

Alright, thank you.

Adam Walsh: All right. Thank you. And we'll move on to Alan Leong with Biowatch.

[noise] animal moved to Alan we all with Biowatch news.

Alan Leong: Hi Joe. Hi Charlie. [inaudible]

Hi, Joe how Charlie.

Hello out on border.

Alan Leong: Thank you. Hey, I want to ask... Thank you.

Yeah. Thank you I want to ask 'em, you're a little more color on but they recently your core they wouldn't be trial, but the hurdle. That's a hard okay, yes milligrams to create a significantly or consistently increased blood levels in the patients and so did you go through a blood levels of kind of pattern or.

Joseph K. Belanoff: Do you have a little more color on the recent NeuroCorona Phase 1b trial at the higher dose? At the higher dose of 900 milligrams, did it create significantly or consistently increased blood levels in the patient? And if so, did you see any dose or blood level-dependent patterns? Or is this kind of hard to tell because there was only a small incremental increase in the blood level?

Just kind of hard to tell because there was only a small incremental.

Level.

Joseph K. Belanoff: Yeah, well, what I think, you know, I really wanted to hold this because I think this is going to be a nice publication when it comes out. You know, I think the main thing to really glean from this is, yes, we did see some increase in plasma levels, and we were, you know, pleased to see that the same effect that we'd seen at 600 milligrams also was true at 900 milligrams. The other important effect, and I don't want this to get lost here, Alan, is that, you know, just as a prescribing doctor, you know, I mean, I guess it's just, you know, sort of life as a doctor, I've never given a medication that has no side effects. You know, if you get a dose high enough where you're really getting maximum efficacy, you begin to experience some side effects.

Yes, well, what I think it.

I really wanted to hold its because I think this is going to be a nice publication when it comes out.

You know what I think the me thing to really glean from is yes, we did see some increase in plasma level and we were you know pleased to see that the same effect that we've seen at 600 milligrams also was true with 900 milligrams. The other important effect I don't want this to get lost your Alan is that you know.

Just a prescribing dr. yeah, I mean, I guess, it's just you know sort of like us Dr. I've never given a medication that hasn't no side effects. You know what do you get a dose high enough, where you're really getting Max I mean, EPCI begin to create some side effects and we haven't seen really no side effects at this at this plasma level of near.

Joseph K. Belanoff: And we haven't seen really any side effects at this plasma level of miracloralin. So my sense of it is that we are not yet at that level where we actually are getting maximum effect. What was really nice to see in this particular space of the study with miracloralin was the same activity, which, you know, you can never take for granted, really appeared just as well the second time around.

Carl and so my sense of it is that we are not not yet at that level, where we actually are getting maximum affects what was really nice to see in this particular stays at the study with near coil. It was the same activity, which you know you can never take for granted a really appeared it just as well the second time.

In around.

Joseph K. Belanoff: I just wanted to follow up on the adenoma question and answer. You know, colon and Cushing syndrome. Are you seeing some prescriptions go to primary care now, especially as less severe patients are being treated? And if so, do you envisage the adenoma subindication elucidating primary care prescriptions? Could you provide any thoughts about that?

Just wanted to follow up on their abnormal question and answer your call him at Cushing syndrome are you seeing some prescriptions go to primary care.

Especially with lots of your patience I'd be treated and it's true do you envision that I didn't know nothing.

Every indication.

The primary care script could you provide any thoughts about that.

Joseph K. Belanoff: Yeah, you know, we mostly do not see them, and in fact, almost all of our prescribers are endocrinologists. The only real exception to that is there are some areas of the country where primary care physicians in more remote areas are sort of the only game in town, and they act as psychiatrists, endocrinologists, and so forth to treat everyone who goes along. No, you know, the broader answer to your question is no, we think this is a disease which really is best treated by endocrinologists. They understand kind of all the ins and outs of cortisol going everywhere, and we expect that that's going to continue to be the case as we go forward.

Yeah, you know, we mostly do not see pay you know in fact, almost all of our our prescribers are endocrinologists. The only real exception to that if there were some areas of the country were and where primary care physicians and more remote areas are sort of deal again in town and they act as psychiatrists endocrinologist and so.

What the tree everywhere, who goes a long no you know the broader answer to your question is now we think this is a disease with really is best treated by endocrinologist. They understand kind of all the ins and outs cortisol goes everywhere and we expect that that's going to continue to be the case as we go forward.

Alan Leong: Well, thanks. And let me just add that that was a knockout quarter, well executed to help to set up your year. So great work.

Well. Thanks, I wanted me to that but that will go knockout quarter. A you know work secure that helped set up so that work.

Joseph K. Belanoff: Thanks Alan, and for everyone who doesn't know Alan, he's calling from the epicenter of a viral contagion, and I'm glad that you're well.

Well enough that thanks, Alan in it for everyone. It doesn't knowhow and he's calling from the epicenter of a a viral contagion and I'm glad to hear well.

No.

Operator: Okay, bye-bye. Listen, I think that that clears the question queue, so thank you to everybody. Please stay healthy, and we look forward to talking to you next quarter. And that does conclude today's conference. Again, thank you all for joining us.

Yeah.

Okay, Bye-bye listen I think that clears our question Q. So thank you to everybody. Please stay healthy and we look forward to talking to the next quarter.

And that does conclude today's conference again, thank you all for joining us.

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Operator: And that does conclude today's conference. Again, thank you all for joining us. Thank you for watching! Thank you for watching!

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