Q1 2022 Corcept Therapeutics Inc Earnings Call

May 5, 2022

Good day and thank you for standing by welcome to the Carson Therapeutics Conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session.

Operator: David Amsellem, Matthew Kaplan, Good day and thank you for standing by. Welcome to the Corcept Therapeutics conference call. At this time, all participants are in a listen-only mode.

Operator: After the speaker's presentation, there will be a question and answer session. And to ask a question during the session, you will need to press star 1 on your telephone keypad, and please be advised that today's conference is being recorded. Should you require further assistance, you may press star zero.

To ask a question during the session you will need to press star one on your telephone keypad.

And please be advised that today's conference is being recorded.

If you require further assistance press star zero.

Atabak Mokari: And I will now turn the call over to Mr. Atabak Mokari, CFO. Please go ahead. Good afternoon, and thank you for joining us. I'm Atabak Mokari, Corcepts Chief Financial, Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update. Copy is available at corset.com. Our complete financial results will be available when we file our Form 10-2. Today's call is being recorded.

And I will now turn the call over to Mr. Athabasca Macquarie CFO . Please go ahead.

Good afternoon, and thank you for joining us out of whack Mccarthy of course, our Chief Financial Officer.

Atabak Mokari: A replay will be available at the investors past events tab of our, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc. These forward-looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We disclaim any intention or duty to update or... Our revenue in the first quarter was $93.7 million, an increase of 18% compared to the first quarter of last year.

Atabak Mokari: As a reminder, each year, insurance reauthorization and coverage of our portion of the donut hole gap in Medicare Part D coverage reduce our first quarter revenue. We expect our revenue growth to continue and have reiterated our 2022 revenue guidance of $400 to $430 million. Net income was $22.8 million, or $0.20 per share, in the first quarter, and our cash and investments increased $32 million in the first quarter to $368.1 million.

Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update.

Copies are available at <unk> dot com or.

Our complete financial results will be available when we file our form.

10-Q with FCC.

Today's call is being recorded a replay will be available at the investors past events tab of our website.

Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations that are subject to risks and uncertainties, which may cause actual results to differ materially from those such statements expressed herein.

These forward looking statements are described in today's press release, and the risk and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K, and our quarterly reports on Form 10-Q.

Please refer to those documents for additional information.

We disclaim any intention or duty to update forward looking statements.

Our revenue in the first quarter with $93 7 million.

An increase of 18% compared to the first quarter of last year.

As a reminder, each year insurance reauthorization and coverage of our portion of the donut hole gap in Medicare part D coverage reduce our first quarter revenues.

We expect our revenue growth to continue and have reiterated our 2022 revenue guidance of $400 million to $430 million.

Net income was $22 8 million or <unk> per share in the first quarter and our cash and investments increased $32 million in the first quarter to $368 1 billion.

Charlie Robb: March 31, 2020. Thank you. I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide an update on our litigation with generic manufacturers Teva and Hikla Pharmaceuticals. Charlie.

<unk> 31.

I will now turn the call over to Charlie Robb, our Chief business Officer.

An update on our litigation with generic manufacturers and Hikma pharmaceuticals.

Charlotte.

Charlie Robb: Thanks, Atabak. There's little to report this court. As many of you know, Teva is seeking to market a generic version of Cortland in violation of our patent. In March 2018, we sued Teva in federal district court. That litigation is still underway. In the midst of our federal court litigation, Teva launched a parallel challenge to the validity of one of our patents, the 214 patent, in a procedure before the Patent Trial and Appeals Board, or PTAB, known as a post-grant review, or PGR.

Novak.

Lou to report this quarter.

As many of you know Teva is seeking to market and generic version of Korlym in violation of our patents in March 2018, we sued Teva in Federal District Court that litigation is still underway in the midst of a federal Court litigation Teva launched in parallel challenge to the validity of one of our patents the two one for Pat.

Charlie Robb: November of 2020, the PTAB rejected Teva's arguments of holding a 214 patent in its entirety, have appealed this loss to the Federal Circuit Court of Appeals where in December of 2021 it lost again. The matter is closed. Having lost the PGR, TEVA can no longer challenge the 214 patent's validity in our district court case. Teva can only argue that his proposed products would not infringe, position we believe has no legal or factual, A year ago, we filed for summary judgment based on Teva's infringement of the 214 patent, have responded by filing its own summary judgment. Summary judgment is a procedure whereby courts can decide a case without holding a trial.

Charlie Robb: We believe the court has all it needs with respect to the 214 patent to decide the case in our favor, in which case it would be barred from marketing generic correlum until 2037 when the 214 patent expires. Court Rules in Teva's Favor, we will proceed to trial, most probably sometime next year, although it is impossible to say with certainty. There's no timetable for the summary judgment ruling, no trial date, and no schedule for any trial-related activities.

And procedure before the patent trial, and Appeals board or <unk> no.

Phone is a post grant review or PCR.

In November of 2020, the pizza have rejected tenants arguments hold it at $2 four patents in its entirety.

Appealed this loss to the Federal Circuit Court of Appeals, where in December of 2021 has lost again.

<unk> closed having.

Having launched the PDR Teva can no longer challenge the 214 patents validity in our district Court case, however, can only argue that as proposed products do not infringe.

<unk>, we believe has no legal or factual support.

A year ago, we filed for summary judgment based on Teva infringement of the <unk> patent.

Have we responded by filing its own summary judgment motion.

Summary judgment is procedure whereby courts can decide the case without holding a trial.

We believe the court has all it needs with respect to the <unk> patent to decide the case in our favor in which case that would be barred from marketing generic core elements from 2037, when the 214 patent expires.

<unk>, we will proceed to trial, most probably sometime next year, although it is impossible assumes certain there.

There is no timetable for the summary judgment ruling no trial date and those scheduled for any trial related activities.

Charlie Robb: All is quiet, which is, in some respects, unfortunate. This case has gone extremely well for us, and we would like to wrap things up. In March 2021, we sued another antifiler, Pigma Pharmaceuticals. In this case, the court has set a fact discovery deadline of July 1 this year. Nothing is scheduled after that.

All of this client which is in some respects unfortunate.

This case has gone extremely well for us and we would like to wrap things up.

In March 2021, we sued another Anda filer, Hikma pharmaceuticals, and the same federal District Court hearing our case against Teva and <unk>.

This case the court has set in fact discovery deadline of July one this year nothing is scheduled after that.

Charlie Robb: With respect to both Teva and Hikma, we are very confident in the strength of our leadership. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Thank you, Charlie. When we are getting closer to resuming our pre-pandemic way of life, some of the challenges posed by, Even though recent COVID cases have tended to be mild, public health precautions taken by patients, physicians, and our commercial team have made it more challenging for physicians to identify, diagnose, and optimally treat all of their and especially those with complex disorders such as Cushing's.

With respect to both Teva and Hikma, we're very confident in the strength of our legal position.

Charlie Robb: Hopefully these challenges will be completely behind us very soon. Despite residual effects of the pandemic, I want to stress how optimistic we are about the present and future of our Cushing Syndrome. This business is built on a strong foundation and effective life-saving medication promoted by a dedicated commercial team. Patients. Leading endocrinologists increasingly believe that there are substantially more patients with, and was once. For many of these patients, Coraline is an excellent, As pandemic conditions and fears recede, we expect our growth to continue and we are reiterating our 2022 revenue guidance of $400 to $430 million.

I will now turn the call over to Dr. Joseph Belanoff, Our Chief Executive Officer, Joe.

Thank you Charlie.

While we are getting closer to resuming our pre pandemic labor like some of the challenges posed by the pandemic persists.

Given the recent Covid cases, it tended to be mild public health cautions taken by patients physicians and our commercial team has made it more challenging for physicians to identify diagnose and optimally treat all of their patients, especially those with complex disorders, such as Cushings syndrome.

Hopefully these challenges will be completely behind us very soon.

Despite residual effects of the pandemic I want to stress how optimistic we are about the present and future of our Cushing syndrome business.

Business is built on a strong foundation, an effective life saving medication promoted by a dedicated commercial team that puts the interest of patients first.

Leading endocrinologist increasingly believes that there are substantially more patients with Cushings syndrome and was once a suit.

For many of these patients Korlym is an excellent treatment.

As pandemic conditions and fears recede, we expect our growth to continue and we are reiterating our 2022 revenue guidance of 400 to four one.

<unk> hundred $30 million.

Joseph Belanoff: We're also extremely optimistic about our clinical development. We have said for years that cortisol modulation has the potential to help treat many serious diseases. The data generated by our ovarian cancer program provides evidence of cortisol modulation's broad application.

We're also extremely optimistic about our clinical development programs. We have said for years that cortisol modulation has the potential to help treat many serious diseases.

The data generated by our ovarian cancer program provides evidence of cortisol modulations broad application.

Joseph Belanoff: In 2022, we will see important results for many of our other ongoing. These programs are examining the lead candidates from a portfolio of more than 1,000 proprietary cortisol modules. Many of which are attractive candidates.

2022, we will see important results for many of our other ongoing clinical programs.

These programs are examining the lead candidates from our portfolio of more than 1000 proprietary cortisol modulators, many of which are attractive candidates for development.

Joseph Belanoff: Like Corallum, these compounds bind strongly to the glucocorticoid receptor, or GR. Unlikely. They have no affinity for the progesterone receptor and so don't cause some of Quarlen's most serious off-target effects. Beyond sharing the qualities of strong cortisol modulation and not perturbing the progesterone receptor. Preclinical and clinical testing have shown that our molecules behave differently from one another in important ways. Some cross the blood-brain barrier, others do not.

Like Korlym these compounds buying strongly to the glucocorticoid receptor GR.

Unlike korlym they have no affinity for the progesterone receptor and so don't cost seven korlym as much serious off target effects.

Beyond sharing the qualities of strong cortisol modulation and not perturbing, the progesterone receptor preclinical and clinical testing have shown that our molecules behave differently from one another in important ways.

Some cross the blood brain barrier, others do not send performed best in models of solid tumor others are more potent in models of metabolic disease.

Joseph Belanoff: Some perform best in models of solid tumor, others are more potent in models of metabolic. Some appear to be tissue specific, others have more global effects. These diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders, including ovarian, adrenal, and prostate cancer, antipsychotic-induced weight gain, NASH, and of course, Cushing's. We plan to start Phase 2 trial in patients with ALS early next quarter and have additional compounds in Phase 1 and preclinical development. Coraline's commercial success has provided the funds to advance all of these, and will continue to do so.

Im appear to be tissue specific others have more global effects.

His diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders, including ovarian adrenal in prostate cancer anti psychotic induced weight gain and Nash and of course Cushings syndrome.

We plan to start phase II trial in patients with ALS early next quarter and have additional compounds in phase one in preclinical development.

Korlym is commercial success has provided the funds to advance all of these programs and we'll continue to do so.

Our oncology program is testing three ANSI anticancer mechanisms first postulated by investigators at the University of Chicago.

Firm by other prominent researchers.

One mechanism is increasing a pop ptosis.

Programmed cell death chemotherapy as mentioned dues and solid tumors.

Cortisol suppresses the positives, meaning cortisol works against the beneficial effect of chemotherapy.

Joseph Belanoff: In our successful trial in women with advanced ovarian cancer, The addition of our Selective Cortisol Modulator, Reliquarolant, enhanced the effect of chemotherapy, likely by blunting cortisol's anti-apoptotic effect. While these patients' disease had progressed on two or more previous lines of treatment, Relochlorone appeared to resensitize some of these patients to the beneficial effects of chemotherapy. As a reminder, our Phase 2 trial was a controlled, multi-center study of 178 women with platinum-resistant ovarian cancer who were randomized to one of three treatment options.

Our successful trial in women with advanced ovarian cancer.

The addition of our selective cortisol modulator <unk> Portland enhance the effects of chemotherapy likely by blending cortisol anti apoptotic effect.

While these patients disease had progressed on two or more previous lines of treatment rella correlate appear to re sensitize. Some of these patients the beneficial effects of chemotherapy.

As a reminder, our phase II trial was a controlled multicenter study of 178 women with platinum resistant ovarian cancer, who are randomized to one of three treatment arms.

Joseph Belanoff: 60 women received a higher dose of Bromel Coraline on the day before, the day of, and the day after they received NAPPAC Litaxil. We call this the intermittent. 58 women received a lower daily Rilakkuma dose in combination with NatPak Litax. We call this the continuous.

60 women received a higher dose abroad Cortland on the day before the date of the date after they receive Nab Paclitaxel we call. This the intermec.

No.

58 women receive lower daily Rolla Cortland in combination with Nab Paclitaxel.

We call this the continuous.

Joseph Belanoff: And 60 women received NAPAQA tax alone, we call this the comparator. The trial's primary endpoint was Progression-Free Survival, or PFS. The women who participated in our study were very ill, and including those with platinum refraction. All had experienced disease progression despite prior lines of therapy, although one had progressed on prior courses of taxing this therapy. Their median number of prior treatments was three. We presented the results from the study at the September 2021 European Society for Medical Oncology, ESMO, provided an update at our investor event in March.

And 60 women receive Nab Paclitaxel alone we call this the comparator arm.

Primary endpoint was progression free survival or PFS.

The women who participated in our study, we're very ill and including those with platinum refractory disease.

All had experienced disease progression despite prior lines of therapy.

<unk> had progressed on prior courses of Taxane based therapy.

The median number of prior treatments was three.

We presented the results from this study in the September 2021 European Society for medical Oncology, ESMO Congress and provided an update at our Investor event in March.

Joseph Belanoff: As these results clearly showed, Reliquoriline can provide benefits to many of the, Those who received Rellacorlin intermittently exhibited a statistically significant improvement in PFS compared to the group that received NAPAclitaxel monoclonal. Hazard Ratio in this group was 0.66 with a p-value of 0.03. The women in the intermittent arm also experienced a statistically significant improvement in duration of response relative to those in the comparator, with a hazard ratio of 0.36 and a p-value of 0.00. The women in the Intermittent Reliquorla group also lived long.

As these results clearly showed relative orland provide benefits to many of these women.

Those are received rella correlate intermittently exhibited a statistically significant improvement in PFS compared to the group that received Nab Paclitaxel monotherapy.

Hazard ratio in this group was six six with a P value of zero to three eight.

The women in the intermittent arm also experienced a statistically significant improvement in duration of response relative to those in the comparator arm with a hazard ratio of <unk>, three six and a P value of 0.006.

The women in the <unk> group also live longer.

Joseph Belanoff: The hazard ratio for this group was 0.67 with a p-value of 0.061. Their median survival, or OS, for this group was 13.9 months, 1.7 months longer than for the NAP Haclopaxil monotherapy group, which was 12.2 months. Importantly, safety and tolerability data for the women treated with ropes.

<unk> ratio for this group was <unk> seven with a P value of <unk> <unk>.

Their median survival or OIS for this group was $13 nine months, one seven months longer than that Nab, Paclitaxel monotherapy, which was $12 two months.

<unk> safety and Tolerability data for the women treated with <unk> plus Nab Paclitaxel was comparable to those who received Nab paclitaxel alone.

Sure. These results in an oral presentation at the American Society of clinical oncology Pascal annual meeting on June six in Chicago.

Based on these positive results, we and our investigators are excited to conduct a phase III trial.

Joseph Belanoff: Based on these positive results, we and our investigators are excited to conduct a phase three trial. Our Phase 3 trial design is very similar to the design of our Phase 2 trial with some standard modifications. For example, as is typical of late-stage clinical trials, our phase three trial will exclude patients with either primary platinum refractory disease.

Our phase III trial design is very similar to the design of our phase II trial with some standard modifications. For example, as is typical of late stage clinical trials, a phase II trial will exclude patients with either primary.

Got them refractory disease patients, who sadly never respond at all to the standard platinum drug therapy, and those who've received already received four or more prior lines of therapy.

Joseph Belanoff: Patients who sadly never respond at all to the standard platform, and those who've received, have already received four or more prior lines of therapy. Excluding such patients from the Phase 2 trial results produced an even greater differential improvement in progression-free survival, duration of response, and overall survival. Women in the intermittent arm experienced a statistically significant improvement in progression-free survival with a hazard ratio of .58 and a p-value of .016.

Excluding such patients from the phase II trial results produced an even greater differential improvement in progression free survival duration of response and overall survival.

Women in the intermittent arm experienced a statistically significant improvement in progression free survival with a hazard ratio of <unk> five eight and a P value of 016 <unk>.

Joseph Belanoff: Duration of response with a hazard ratio of 0.26 and a p-value of 0.001 and overall survival with a hazard ratio of 0.52 and a p-value of 0.01 relative to patients who receive NAPAQLITAX alone. We have received very positive feedback from leading gynecologic oncologists regarding the promise of Relacorlin as a treatment for women with this desired disease. In their view, Relacorlin's potential benefits improve survival without increased side effects, constitute an important medical advance.

Duration of response with a hazard ratio of <unk>, six and a P value of 0.001, and overall survival with a hazard ratio of <unk> five two and a P value of <unk> relative to patients who receive Nab paclitaxel alone.

We have received very positive feedback from leading gynecologic oncologists regarding the promised umbrella korlym as a treatment for women with this desire disease.

Our view <unk> as a potential benefit improved survival without increased side effect burden will constitute an important medical advance.

Joseph Belanoff: They feel that the Relacoral and PlusNav Paclitaxel has the potential to become a new standard of care in the area. We have designed and will conduct our phase three trial with advice from two leading researchers. The Gynecologic Oncology Group in the United States and the European Network of Gynecological Oncology Trials Group in Europe.

They feel that the real Cortland, plus Nab Paclitaxel has the potential to become a new standard of care in ovarian cancer.

We have designed and we will conduct our phase III trial with advice from two leading research grid.

Logic oncology group in the United States and the European Network of Gynecological oncology trials group in Europe , most of our investigators will be drawn from these groups we.

Joseph Belanoff: Most of our investigators will be drawn from, We and members of the Gynecologic Oncology Group will meet with the FDA in June to discuss the optimal path forward, and we'll initiate our Phase III trial shortly thereafter. Second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth path. Cortisol stimulation is a major reason why patients with metastatic prostate cancer treated with the widely prescribed androgen receptor antagonist, enzalutamide, eventually experience resurgent disease.

And members of the Gynecologic oncology group will meet with the FDA in June to discuss the optimal path forward and we will initiate our phase III trial shortly thereafter.

Second mechanism by which cortisol modulation may prove useful just by blocking an important tumor growth pathway.

Cortisol stimulation is a major reason why patients with metastatic prostate cancer treated with a widely prescribed androgen receptor antagonist and <unk> eventually experienced resurgent disease deprived of androgen stimulation their tumor switched to cortisol activities to stimulate growth.

Joseph Belanoff: Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape. We recently completed enrollment in our dose-finding study of our Selective Cortisol Modulator, combined with enzalutamide in men with castrate-resistant prostate cancer. Investigators at the University of Chicago are conducting a similar study of urella correlants combined with enzalutamide in the same patient population.

Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route.

We recently completed enrollment in our dose finding study of our selective cortisol modulator extra cortland combined and solidified in men with castrate resistant prostate cancer.

Investigators at the University of Chicago are conducting a similar study umbrella Portland, combined with and solidified in the same patient population we.

We expect to select an optimum dose of either <unk> or <unk> to take forward this quarter.

Joseph Belanoff: We expect to select an optimum dose of either relacorrelant or hexacorrelant to take forward. The third mechanism seeks to reduce cortisol suppression of the immune system. Quality of cortisol that likely blunts the effectiveness of immunotherapy. We are conducting an open-label, phase 1b trial, abrela-correlant, plus the PD-1 checkpoint inhibitor, pembrolizumab, Merck's drug, Keytruda, in patients with advanced adrenal cancer whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and could, A Usual Quickly Lethal Combination, Pembrolizumab is rarely effective as monotherapy in these patients.

Joseph Belanoff: We believe that these patients' cortisol excess may be countering the intended effects of Pembrolizumab, which is to stimulate. Our trial is evaluating whether Rella Chloraline can treat these patients' Cushing's Syndrome by reducing excess cortisol activity and, by reversing cortisol-induced immune suppression, allow Pembrolizumab to achieve its full cancer-killing effect. We plan to enroll 20 patients at seven sites in the United States.

Joseph Belanoff: The primary endpoint of this study is objective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival. I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator, Miracle, and patients with NASH, serious liver disorder. Patients who received MiraCorrelant in our Phase 2 trial exhibited large rapid reductions in liver, but also substantial transient elevations of the liver enzymes ALT. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected, and are rarely seen over any period of treatment.

Barry endpoints, including progression free survival duration of response and overall survival.

I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator mirror correlate in patients with Nash serious liver disorder.

Patients, who received mirror cortland in our phase II trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of liver enzymes ALC ASD.

The improvement in liver fat in these patients was greater than occurred much more rapidly than we had expected and are rarely seen over any period of treatment.

Joseph Belanoff: As a reminder, our trial's primary endpoint was a 30% reduction in liver fat after 12 weeks. In fact, patients exhibited reductions ranging from 38.5% to 73.8% after receiving Miracloraline for just a month. It may be that the rapidity of miracoral and SPAT-reducing effect caused the patient's ALT and AST to rise. One way the liver sheds fat is by metabolizing it into fatty acids, and excessive amounts, irritate.

As a reminder, our trial's primary endpoint was a 30% reduction in liver fat. After 12 weeks of treatment in fac patients exhibited reductions ranging from 38, 5% to 73, 8% after receiving <unk> correlate for just a month.

And maybe that the rapidity amira <unk> fat, reducing effect caused the patient's ALC and Asps rise one way the liver ships fat despite metabolizing into fatty acids, which is in excess of amounts irritate deliver.

Joseph Belanoff: Interestingly, lipids in the blood of these patients did not increase. Providing support for the idea that mirror polaroids cause their excess fat to be metabolized immediately within the. The goal of our Phase 1b dose-finding trial of patients with presumed NASH is to identify a dosing regimen. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, We're also evaluating miracoralin as a potential treatment for patients with another serious and widespread Antibiotic Antipsychotic Induced Weight Gain, In the United States, 6 million people take antipsychotic medications, such as lansipine and risperidone. Treat Illnesses Including Schizophrenia, Bipolar Disorder, and Depression. While these drugs are very effective, the exact steep price in the form of rapid and sustained weight gain, which leads to cardiovascular and metabolic disease.

Interestingly lipids in the blood of these patients did not increase providing support for the idea that mirror Portland caused their excess fat to be metabolized immediately within the liver.

All of our phase <unk> dose finding trial in patients with presume Nash is to identify a dosing regimen that significantly reduces fat without causing excess of.

Liver irritation.

We're also evaluating <unk> as a potential treatment for patients with another serious and widespread disorder anti psychotic anti psychotic induced weight gain.

States 6 million people take anti psychotic medications, such as Olanzapine and risperidone to treat illnesses, including schizophrenia bipolar disorder and depression.

These drugs are very effective the exact steep price in the form of rapid and sustained weight gain which leads to cardiovascular and metabolic disease.

Joseph Belanoff: The average life expectancy of patients in the United States who chronically take antipsychotic medication, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc such as heart attacks and strokes. We are conducting two double-blind placebo-controlled phase 2 trials of miraclorelant in patients with this disorder. Gratitude, and Gratitude 2, both of which I'm pleased to say are now fully enrolled. These trials seek to build on the positive data from our study of mirror correlates in healthy substances. 2020, we completed a trial in which 96 healthy subjects received a LAMP, and either 600 milligrams of Miracorland, 900 milligrams of Miracorland. We'll see you both for 14 days.

Average life expectancy of patients in the United States, who chronically take anti psychotic medication is decreased by 20 years frequently due to increased cardiovascular events, such as heart attacks and strokes.

Joseph Belanoff: Subjects who received miracorelin gained significantly less weight than those who received placebo. They also exhibited a smaller increase in triglycerides and an ALT and an AST, which typically exhibit sharp transient increases at the start of the lansipine therapy. Paper describing these results was published in the Journal of Clinical Psychopharmacology. The Gratitude Trial is evaluating whether Miracoralline can reverse recent antipsychotics. Patients with schizophrenia or bipolar disorder receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of marijuana or placebo for 12 weeks.

We are conducting two double blind placebo controlled phase II trials of <unk> in patients with this disorder.

Gratitude and gratitude to.

Both of which I'm pleased to say are now fully enrolled.

These trials seek to build on the positive data from our study of Mirror Orleans in healthy subjects. In 2020, we completed a trial in which 96 healthy subjects received olanzapine and either 600 milligrams of mirror Orland 900 milligrams.

Or placebo for 14 days.

Subjects, who received mirrored correlate gained significantly less weight and those who received placebo.

They also exhibited a smaller increase in triglycerides and in <unk>, and ASD, which typically exhibit sharp transient increases in the startup of Olanzapine therapy.

A paper describing these results was published in the journal of clinical Psychopharmacology.

The gratitude trial is evaluating the Mira <unk> can reverse recent antipsychotic induced weight gain.

With schizophrenia or bipolar disorder received in addition to their established dose of anti psychotic medication, either 600 milligrams of <unk> or placebo for 12 weeks.

Joseph Belanoff: Gratitude is being conducted at 30 centers in the United States. Our Gratitude II study is testing miracloraline as a treatment for long-standing antipsychotic, Patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams or 900 milligrams of miracloraline or placebo for 26 years. Gratitude, too, is being conducted at 35 centers in the United States. The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be, We look forward to the data readouts from these trials in the fourth quarter.

<unk> is being conducted at 30 centers in the United States.

Gratitude two study is testing mirror korlym as a treatment for long standing antipsychotic induced weight gain patient.

Patients with schizophrenia will receive in addition to their established dose of anti psychotic medication.

600 milligrams or 900 milligrams, amira korlym or placebo for 26 weeks.

<unk> two is being conducted at 35% interest in the United States. The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be examined.

We look forward to the data Readouts from these trials in the fourth quarter. If the results are positive we plan to advance our program to phase III next year.

Joseph Belanoff: If the results are positive, we plan to advance our program to phase three next year. As most of you know, roaquarelant is our planned successor to Quorola for the treatment of hypercortisol. We are evaluating two phase three trials, Grace and Grady. Like all of our proprietary molecules, relacorrelant is a selective cortisol module. Like Chorla, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike coral, does not bind to the progesterone receptor, PR for short. It is not the abortion pill and it does not cause other PR-related side effects, including endometrial thickening and vaginal bleeding.

As most of you know <unk> is our planned successor to Korlym for the treatment of hyper cortisol rhythm.

We are evaluating two phase III trials Grace and gradient.

Like all of our proprietary molecules <unk> is selective cortisol modulators like korlym. It achieves its effect by competing with cortisol at the glucocorticoid receptor.

Unlike korlym it does not bind to the progesterone receptor PR for short it is not the abortion pill and does not cause other PR related side effects, including endometrial thickening and vaginal bleeding.

Joseph Belanoff: By a different mechanism, Relochorlin also does not appear to cause hypokalemia, low potassium. Serious side effect experienced by 44% of patients in Quirrell's pivotal trial. Coraline induced hypokalemia is a leading cause of coraline discontinuation.

By a different mechanism rella Korlym also does not appear to cause hypokalemia low potassium.

Serious side effects experienced by 44% of patients can korlym as a pivotal trial.

Korlym induced hypokalemia is a leading cause of korlym discontinuation.

Relative Orleans phase II efficacy and safety data were strong.

Joseph Belanoff: Relevue Ireland's Phase II efficacy and safety data were strong. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing's syndrome. There were no roentgen-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced hypokalemia.

Patients experienced meaningful improvements in hypertension, and glucose control as well as in a variety of other signs and symptoms of Cushing syndrome.

There were no rella correlate induced instances of endometrial thickening or vaginal bleeding and no drug induced hypokalemia.

Joseph Belanoff: The trial results were published in Frontiers in Endocrinology. Our GRACE trial has a planned enrollment of 130 patients with any etiology of Kutch, As a reminder, Grace has a randomized withdrawal trial. All patients receive Reliquor Lint for 22 weeks in an open label.

Trial results were published in frontier is in endocrinology.

Grace trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome.

As a reminder, grace is a randomized withdrawal trial design all patients receive <unk> for 22 weeks in an open label phase those who meet response criteria for improvement in glucose control hypertension or bull are randomized to continue treatment with <unk> or placebo for 12 weeks.

Joseph Belanoff: Those who meet response criteria for improvement in glucose control, hypertension, or both are randomized to continue treatment with relacorrelant or placebo for 12 weeks. While the pandemic had a real impact on the execution of this trial, we and our investigators are eager to take race to the finish. We expect GRACE to serve as the basis for our NDA submission in Cushing, which we now expect to submit in the second half of 2020.

While the pandemic had a real impact on the execution of this trial, we and our investigators are eager to take rates to the finish line, we expect grades to serve as the basis for our NDA submission in Cushing syndrome, which we now expect to submit in the second half of 2023.

Joseph Belanoff: Our second phase three trial, Gradient, is studying relacorrelance effects in patients whose Cushing syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but ultimately their health outcomes are poor.

Our second phase III trial gradient studying rella correlates effects in patients, whose cushings syndrome is caused by an adrenal adenoma or adrenal hyperplasia.

Patients with this etiology of Cushing syndrome, often experienced a less rapid decline, but ultimately their health outcomes are poor.

Joseph Belanoff: Gradient has a planned enrollment of 130 patients and is being conducted at many of the sites participating in GRADE. Gradient is the first controlled study in patients with this type of cushing. While we do not expect our NDA and Cushing Syndrome to depend on data from gradient, we do expect that its findings will help improve the care of these increasingly recognized, Finally, a brief word about data, which has shown great promise in animal models of ALS.

Gradient has a planned enrollment of 130 patients and is being conducted at many of the sites participating in grace.

Gradient is the first controlled study in patients with this type of Cushing syndrome.

While we do not expect our NDA Cushing syndrome could depend on data from gradient. We do expect that its findings will help improve the care of these increasingly recognized patients.

Finally, a brief word about data to correlate which has shown great promise in animal models of ALS.

Yes, we are.

Joseph Belanoff: We are on track to initiate a Phase 2 trial early next quarter. This study is being shepherded by TRICALS, the leading ALS academic consortium in Europe. We will have more to say as that trial gets underway. We expect our commercial growth to continue as pandemic conditions recede. Remember, even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.

We're on track to initiate a phase II trial early next quarter. This.

This study is being shepherded by try counts the leading AOS academic consortium in Europe , we will have more to say as that trial gets underway.

We expect our commercial growth to continue as pandemic conditions received remember.

Remember even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.

Joseph Belanoff: We believe cortisol modulation can help treat many serious disorders. I believe for which our development programs are now providing a growing body of, Corallum and Relacorallant for patients with Cushing syndrome provide an easy-to-see example of cortisol modulation's benefits. The data generated by our ovarian cancer program provides a good example of cortisol modulation's broad application.

We believe cortisol modulation can help treat many serious disorders.

I believe for which our development programs are now providing a growing body of evidence.

Korlym and <unk> for patients with Cushings syndrome provide an easy to see example of cortisol modulations benefit.

The data generated by our ovarian cancer program provides a good example of cortisol modulations broad application.

Joseph Belanoff: 2022 opened with strong overall survival results in our phase two trial of adjunct abrilla coraline and platinum-resistant ovarian cancer. The remainder of 2022 will provide results from other important, Cortisol Modulation Portfolio. In particular, NASH and antipsychotic-induced weight, Both are following up on extensive preclinical and encouraging early clinical.

2020 to open with strong overall survival results in our phase II trial of adjunctive <unk> correlate in platinum resistant ovarian cancer the.

The remainder of 2022 will provide results from other important programs and our cortisol modulation portfolio.

In particular, Nash and anti psychotic induced weight gain.

Both are following up on extensive preclinical and encouraging early clinical results. We're also excited to start a phase II trial using another of our proprietary com compounds dazzle korlym to treat patients with ALS.

Joseph Belanoff: We are also excited to start a Phase II trial using another of our proprietary, compounds, dazzling, to treat patients with ALS. Last but not least important, additional proprietary compounds are advancing. This is an exciting time.

Last but not least important additional proprietary compounds are advancing towards the clinic.

This is an exciting time of course yet.

I'd like to thank our employees for their tremendous effort and dedication.

We recently announced three key additions to our commercial and development leadership teams and are expanding our teams more broadly to support what we believe is incredibly broad and strong pipeline and a substantial commercial opportunity.

I'll stop here for questions.

Thank you presenters.

Operator: Thank you, presenters. At this time, for the participants, you may press star one on your telephone keypad, and if you would like to withdraw your question, you may press the pound key. Please pause for just a moment to compile the Q&A roster. We have our first question from Matt Kaplan from Leidenberg, please go ahead. I congrats on the quarter and strong results. Thank you, Matt.

It's time for the participants you May press star one on your telephone keypad and if we would like to withdraw. Your question you May press the pound key.

Hello.

A moment to compile the Q&A roster.

Okay.

We have our first question from Matt Kaplan from Ladenburg. Please go ahead.

Hi, congrats on the quarter strong results.

Okay, just wanted to focus a little bit.

Operator: I just wanted to focus a little bit on rel-equivalent in Cushing's and the grace and gradient studies. Given your new guidance, how should we think about how long it should take to prepare an NDA to file in the second half of 23? Is that roughly a six-month process or something like that?

Well equivalent in Cushing and okay great.

Got it.

Given your given your new guidance, how should we think about.

How long it should take to prepare an NDA.

To file in the second half of two.

23.

Is that is that roughly a six month process or something like that.

William Guyer: Well, just to introduce an important voice in the room, I'd like to reintroduce you to Bill Guyers, who's our Chief Development Officer, to take that question. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc, Okay, okay, that's helpful. And, and in terms of gradient, where, how is that progressing? And in terms of enrollment? Graded study is enrolling in parallel to that of GRACE, so very similar. Okay, so kind of on a parallel path on a parallel path.

Well just to introduce an important voice in the room I'd like to reintroduce you to Bill Guy or two that Chief development officer to take that question. Let me, let me rest of my voice for a little bit alright. Thank you. Thank you for that question since we're planning for an NDA in the second half of 2023, approximately four to six months.

Prior to that we should have completed the study and then allow us to prepare for that NDA.

Okay. Okay. That's helpful and in terms of gradient, where how is that progressing.

In terms of enrollment.

Great Aunt <unk> study is enrolling in parallel to that great. So very similarly.

Okay, so kind of on a.

On a parallel path on a parallel path yes.

Okay Alright.

And then in terms of.

The metabolic.

Our metabolic program.

Metabolic disease.

Program.

Okay.

In terms of the phase two data for both of the.

Both of the studies that are expected in the second half of this year in the fourth quarter.

What what would you need to see to get excited there too.

To move into phase III in.

'twenty three.

It comes from anti psychotic weekend anthrax.

Unknown Executive: Yeah. Great. And, And then in terms of the metabolic program, metabolic disease program, is in terms of the phase two data for both of the, both of the studies that are expected in the second half of this year in the fourth quarter. What would you need to see to get excited there to move into phase three in 2023? Unknown Attendee, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, We're going to see a lot of data from both of these trials and learn a lot after we've analyzed the data to determine their implication.

There are many patients with anti psychotic induced weight gain and this is the first time that we've ever done this important experiment.

I see a lot of data from both of these trials and you learn a lot and we've analyzed the data to determine their implications as we learned from this data set we're going to primarily focus as Joe said earlier on.

Unknown Executive: You know, as we learn from this data set, we're going to primarily focus, as Joe said earlier, on evaluation of weight changes for mirror correlant at different doses versus that of placebo, as well as other metabolic factors that we're going to be evaluating in the study compared to, So it's that collection of overall data set of weight changes and metabolic factors, will really help guide us forward on the next steps forward of how to proceed to phase three. Okay, great.

Valuation of weight changes for Mira cortlandt at different doses versus placebo as well as other metabolic factors that we're going to be evaluated in this study compared to that.

So with that collection of overall data set of weight changes in metabolic factors that will really help guide us forward on the next steps forward to kind of proceed to phase III next year.

Okay, great. Thanks.

Unknown Executive: Well, thanks for taking the question. We have our next question from Chris Howerton from Jeffries, please go ahead. Great. Thanks so much for taking the questions. I think maybe I'll start with thinking about the revenue guidance that you provided this year. Relative to the first quarter performance, you're going to have to have the best three quarters that you've ever had in order to meet those guidance.

Thanks for taking my questions.

Thanks.

We have our next question from Chris Howerton from Jefferies. Please go ahead.

Great. Thanks, so much for taking the questions.

<unk>.

I think maybe I'll start with thinking about the revenue guidance that you provided this year realm.

Relative to the first quarter performance Youre going to have to have the best three quarters that you've ever had in order to meet the guidance. So I guess, what gives you the confidence that youll be able to achieve that.

Yes no.

I understand the question and again like to reintroduce you to Shama, Duke who is the president of our Endocrinology Division, yes. Thanks for the question.

Sean Maduck: And I want to just sort of reiterate what was said in the comments and what Joe had said previously that, and we are reiterating our guidance. I believe we remain on track for that. We'll talk a little bit about just the first quarter in particular.

I wanted to just sort of reiterate what was said in the comments on what Joe had said previously.

And we are reiterating our guidance and believe.

Sean Maduck: There's a couple of things that occurred in that. There's the expected and then the onyx— Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, More free drug, but not fewer patients. So I'd say that's the expected piece of it.

Remain on track for that we'll talk a little bit about just the first quarter in particular.

Couple of things that occurred and that there is the expected and unexpected.

We expected out of Ark mentioned in his opening remarks, I mean every January we see challenges in the areas of interest.

Okay have coverage and.

We make sure the treatment is not interrupted for patients we provide free drug until that paid coverage resumes and that leads to.

More free drug, but not pure patients on medicine. So I'd say, that's we expect that piece of it the unexpected piece that affected us in Q1.

Sean Maduck: The unexpected piece that affected us in Q1 was, was increased COVID's concern. So in Q4 and then the first half of Q1, the Omicron surge created disruption to our business, some disruption. I would say practices were closed again, like they were earlier in the year and it was hard for our clinical specialists to get in and patients were also hesitant to actually go and see their doctors, which is necessary for appropriate screening.

<unk> was increased cohorts concerns. So Q4, and then the first half of Q1, the omicron surge created disruption to our business. Some disruption I would say practices were closed again like they were.

Earlier in the year and it was hard for our clinical specialists to get in and patients were also hesitant to actually go and see their doctors, which is necessary for appropriate screening and testing.

Sean Maduck: And in addition to that, the first time during this COVID window, our team was affected, multiple members of our field force were actually actually caught the virus and had to be out of the field, which which limited their time, https://www.swayampakula.com, So, you know, all that being said, Omicron came and it went pretty quickly and things are really starting to return to normal and we're optimistic that improvement is going to continue, why we feel confident in the next. And just Chris, you know, because I do want to emphasize and your math is absolutely correct. In order to meet our revenue guidance, we have to have the best course that we've ever had.

In addition to that the first time during this COVID-19 window. Our teams effective multiple members of our field force, we're actually actually top of Iris and has to be out of the field, which limited their time.

Concerning position so.

I've talked about this in the past, but it takes many interactions with clinical specialists before a physician goes from korlym naive to actually prescribing there.

And the lag effect of both okay.

The omicron surge and that limited field time have had an impact on our on our Q1. So all that being said army ground team and it went pretty quickly and things are really starting to return to normal and we're optimistic that improvement is going to continue through 2022, which is why we feel confident in the next few quarters, yes, and just Chris.

Because I do want to emphasize and your math is absolutely correct in order to meet our revenue guidance, we have to have the best quarters that we've ever had and that is our expectation.

Okay, that's awesome.

Bill Guyer: And that is our, Okay, I mean, that's awesome. Okay, and then, if I may, on the ovarian cancer phase three trial, I could totally have this wrong, but my understanding is that experimental agents in combination need to be studied separately first. And I guess, what are your expectations of how the FDA is going to treat, you know, NABPAC or Taxol, given that it doesn't have a label in ovarian cancer going into that study? Thank you for that question. This is Bill Guyer.

Okay, and then if I may on the ovarian cancer phase III trial I could totally have this wrong, but my understanding is that it.

Sparing mental agents in combination needs to be studied separately first.

Yes.

What are your expectations of how the FDA is going to trade.

Nab Paclitaxel given that it doesn't have a label in ovarian cancer going into that study.

Okay. Thank you for that question this is Doug.

Bill Guyer: So, when it comes to NatPak Litaxil, there is a wealth of research that has gone along with NatPak Litaxil in ovarian cancer. With that package, I think that helps us since this isn't just the first time we've ever studied it, we're adding to that body. The other key piece is those who have done the studies with NAPAQUA-Taxel primarily were the gynecological oncology organization, the GOG, and they are the people who we partnered with to help us with the efforts, and they have a wealth of experience in working with the FDA to shepherd drugs through phase three but also to get drugs approved through the FDA. We feel very confident that what we've designed in our trial will move forward very expeditiously.

So when it comes to Nab Paclitaxel. There is a wealth of research that is Scott along with Nab Paclitaxel in ovarian cancer. So with that package I think that helps us since this isn't just the first time, we've ever studied it we're adding to that body of research. The other key pieces those who have done the studies with Nab Paclitaxel <unk>.

Merrily were the gynecological oncology organization the Geo Chi.

And they are the people, who we partner with to help us with the FDA and they have a wealth of experience in working with the FDA to shepherd drugs through phase III, but also to get drugs approved through the FDA. So we feel very confident that what we've designed in our trial.

We'll move forward very expeditiously and addition, and we're going to be talking with the FDA This quarter and so we will seek their guidance I'm very shortly but.

But we still plan to initiate a phase III study this quarter.

Okay.

Bill Guyer: Well, thanks so much. And then I guess, if I may, if you'll let me on the last one for the GRACE trial, I think point taken in terms of the COVID impacts on enrollment, but I actually can't remember what the sites were. Is there any impact of the unfortunate war conflict that we're having on enrollment? Or would there be any impact of loss to follow up potentially? Yeah, you know, it's interesting, because you're the first person to ask that question. And it's a good question, you know, because we actually, I can tell you, at the beginning of the study had actually considered, having sites in Ukraine. Luckily, did not happen.

Alright, well, thanks, so much and then I guess.

If I may if you let me on the last one for the Grace trial.

I think point taken in terms of the COVID-19 impacts in enrollment, but I actually can't remember what the sites where is there any impact of the unfortunate where conflict that we're having on the enrollment or.

Would there be any impact of lost to follow up potential.

Yes.

It's interesting because you're the first person to ask that question.

It's a good question because we actually I can tell you at the beginning of the study can actually considered.

Having sites in Ukraine, and just I guess in hindsight.

Luckily did not have that there.

Add to all the problems that exist in that country. So far we really haven't seen that as much of an issue last week we were at.

Bill Guyer: Unknown Speaker, So far, we really haven't seen that as much of an issue. Last week, we were at, A very well attended investigator meeting in Europe, and we didn't really hear any feedback about that being a problem at all. So I'm going to say no, it has not. But, you know, of course, the future over there is far less certain than we'd like it to be. But no, at this point, no issue. And we certainly would talk, Awesome.

A very well attended investigator meeting in Europe , and we didn't really hear any feedback about that being a problem at all so im going to say no. It has not but of course the future over there.

As far less certain than we'd like it to be but no at this point no issue and we.

We certainly would talk about it and here they are became an issue.

Awesome, Okay, alright, well thanks for all the answers to my questions and congratulations on the progress so far.

Bill Guyer: Okay. All right. Well, thanks for all the answers to my questions and congratulations on the progress so far. You're welcome, Chris.

You're welcome Chris Thank you.

We have our next question from Edward Nash from Canaccord Genuity. Please.

Operator: Thank you. We have our next question from Edward Nash from Canaccord Dignity. Please go ahead. Hi.

Please go ahead hi.

Hi, guys. Thanks for taking my question I Hope you guys are doing well.

Operator: Hi, guys. Thanks for taking my question. I hope you guys are doing well. One of the states has been in the updates in the New Jersey AG investigation, have they requested anything beyond the original inquiry to date? I'm going to turn you back over to Charlie.

One other thing I'd say, it's been any updates in the New Jersey AG investigation have they requested anything beyond the original inquiry to date.

Im going to turn you back over to Charlie Robb.

Charlie Robb: Unknown Speaker, Unknown Attendee, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc. Let me just provide a little bit of context so you can understand why I'm saying that. Which is that, you know, for those who don't follow this, What Ed's referring to is a request for information that we received from the DOJ, a subpoena back in November of last year. As we announced then in our doing, we said we would cooperate with their inquiry, which we're certainly doing, and our approach is to provide them with the information that they want as fast as we can, and always faster than they're able to. And why is that?

Okay. So.

Ed.

So the answer is that.

The nature of these investigations generally is that they start with.

Initial of stuff in there.

Fluid back and forth, but really have nothing to announce about that an investigation right now.

But I think the.

More interesting I can say is that I regret having nothing to announce about the investigation, so far and let me just provide a little bit of context.

Understand why I'm, saying that we just that.

For those who don't follow this as closely.

<unk> to us.

A request for information that we received from the SEC.

Doj.

Back in November of last year, as we announced then and are doing we said, we would cooperate with their inquiry, which we're certainly doing it.

Our approach is to provide them with the information that they want as fast as we can and always faster than they're able to absorb.

And why is that.

Charlie Robb: The reason is we really want to stay ahead of them. We want them to always have information from us to review because that's the way you move things along as experts. Unknown Attendee, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, These, the DOJ is staffed by public servants who are interested in the truth, and the truth for us is our friend.

The reason is we really want to stay ahead of them. We always have information from us to review because that's when you move things along as expeditiously as possible.

Inquiry, although not directly causally linked in any way, but is it in some way to sort of the culmination.

Short seller allegations that turned into a class action lawsuit that were really good now.

And now we have this Doj inquiry and the reason I welcome speed.

<unk> resolution in that cases these.

This is the Doj is staffed by public servants, who are interested in the truth.

And the truth for US is our friend and so I wanted to get our story in front of them as fast as we possibly can.

Charlie Robb: And so I want to get our story in front of them as fast as we possibly can, because I think that is how we will put this all behind us happily and be able to move forward without this distraction. So I wish there was something to say. There will be something to say in the future, but right now there's. That's great. No, I appreciate that detail.

Because I think that is how we will put this all behind us happily and be able to move forward without distraction. So I wish there was something.

There will be something to say in the future, but right now there's really nothing to add.

That's great and I appreciate I appreciate that detail and then just my last question is just regarding your correlate.

Charlie Robb: And then just my last question is just regarding your correlant in antipsychotic-induced weight gain. So how do you think about patient characteristics of those with recent versus longstanding weight gain? I mean, are they are there any differences in metabolic parameters between each group?

How they can do weight gain so how do you think about patient characteristics of those with recent versus long standing weight gain.

Are there any differences in metabolic parameters between each group do you think the patient.

With long standing.

Have achieved homeostasis with regard to metabolic parameters after weight gain and does that impact your thoughts on on the potential duration of treatment for the patients versus recent haywood.

Yes.

Very good question.

I haven't gotten that one either but.

Charlie Robb: I've gotten that one either, but really it's an opportunity for me to talk a little bit about it. Patients who take anti-psychotic medications, and I can tell you... Describes them, tend to gain weight very quickly, and it's often very difficult to- matter what.

Really it's an opportunity for me to talk a little bit about it.

Patients, who take antipsychotic medications and I can tell you with someone who prescribes them.

And to gain weight very quickly and it is often very difficult for them to lose it no matter what they do over time and yet they have to take their anti psychotic medication.

Charlie Robb: Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, The best thing that schizophrenia can do is not take their medication. And the second worst thing they can do is take their medication, because these medications really do cause serious, serious metabolic problems. And yet for the purpose, very good at.

As I sort of think about patients with schizophrenia.

Ruefully say the worst thing a patient with.

Schizophrenia can do is not take their medication.

Second worst thing they can do is take their medications.

Because these medications really do cause serious serious metabolic problems and yet for the purposes. It's a very good at.

Charlie Robb: Producing psychosis, they're quite effective. So we're doing the study. You know, no one's ever done in some sense, either of these two studies, which is, can you reduce the weight gain caused? Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc or take a look at the other group of which the numbers in the United States, you know, are really ample of patients who have taken antipsychotic medication for a long time and have substantial weight gain, you know, but are but are little Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, So I don't know what the results of these studies are gonna be.

Reducing psychosis they are quite effective.

So we're doing the study no one's.

As ever done some sense either of these two studies, which is can you reduce the.

Gain caused by antipsychotic medications at all and sort of the new <unk>. The early study of people, who you can really track to the very beginning when they began their anti psychotic medication. It's within the last six months can you actually takeaway that weight gain or take a look at the other group of which the numbers in the United States.

We are really ample of patients who have taken anti psychotic medication for a long time and have substantial weight gain but are but are a little.

Potentially a little less specific to the anti psychotic medications because they've.

Their life in America American died and so on and so forth.

I don't know.

With the results of these studies are going to be obviously I have a hypothesis that our medicine will be beneficial for both of those groups, but as bill mentioned before much data.

Charlie Robb: Obviously, I have a hypothesis that our medicine will be beneficial for both of those groups. But as Bill mentioned before, much data to come, and it's gonna be very, very interesting both for us and for the field to see if we can really do something about this problem, whether it's a short-term problem or a long-term problem, it's a big problem. And I really look forward to seeing the, turning over the cards in these blinded studies. Great, thanks so much. Really appreciate the color there.

And it's going to be very very interesting both for us and for the field to see if we can really do something about this problem, whether it's a short term problem or a long term problem. It's a big problem and I really look forward to seeing that turning over the cards. These blinded studies.

Great. Thanks, so much really appreciate the color there.

Charlie Robb: Look forward to a strong next three quarters. Thank you. Thanks.

Forward to a strong three quarters. Thank you.

Thanks.

Yes.

We have our next question from Greg <unk> from <unk> Securities. Please go ahead.

Operator: We have our next question from Greg Frazier from Truist Securities. Please go ahead. Thanks.

Hey, Thanks, good afternoon folks I am not sure if I missed this but on Grace did you comment on how many patients have been enrolled so far.

Operator: Good afternoon, folks. I'm not sure if I missed this, but on Grace, did you comment on how many patients have been enrolled so far? No, I did not comment on the number of patients enrolled so far. You know, we don't typically comment on the number of patients that are totally enrolled, but I will give you some commentary on coming out of the pandemic. March was our best enrolled to date of this trial. Seeing good progress coming out of the pandemic. That's just not a metric we report. Yep, understood. SG&A's been stepped up in the quarter. Were there any temporary drivers of the higher spend in Q1?

No I did not comment on the number of patients enrolled so far.

We don't typically comment on the number of patients that are totally enrolled but I will give you some commentary on coming out of the pandemic March was our best enrolled to date of this trial. So we're seeing good progress coming out of the pandemic.

Just not a metric we report Greg.

Okay understood.

SG&A spend stepped up in the quarter were there any temporary drivers of the higher spend in Q1 or is that level sort of a new normal from which you'll grow.

Unknown Executive: Or is that level sort of a new normal from which they'll grow? Sure. Hey, Greg.

Auto book.

Hey, Greg.

Yes.

Unknown Executive: That's, That's pretty, you know, as we talked about, we've expanded our teams, and that's, that's a big driver of it. There are some temporary things like legal, For the most part, I think of that as our goal. Got it.

That's pretty.

We talked about we've expanded our teams and that's that's a big driver of it there are some temporary things like legal expenses, but for the most part I think of that as our portfolio.

Got it okay.

Joseph Belanoff: Okay. And then you have a number of academic collaborators that are conducting studies of cortisol modulators in different settings, like alcohol use disorder, epilepsy. Do you anticipate getting data from any of those studies this year? If you could just lay out what you might learn and when from those activities, that would be helpful.

And then you have.

A number of academic collaborators that are conducting studies of cortisol modulators in different settings like alcohol use disorder epilepsy.

Do you anticipate getting data from many of those studies. This year. If you could just lay out what you might learn and learn from those activities that would be helpful. Thank you. Yes. This is really like a watershed day I love talking about this stuff no one ever asked me about itself.

Joseph Belanoff: Thank you. Yeah, this is really like a watershed day. I love talking about this stuff. No one ever asks me about it, so you got me started.

Got me started we have at any given point, including today about 35 different academic collaborations.

Joseph Belanoff: We have at any given point, including today, about 35 different academic collaborations, about half in the United States, half outside of the United States, about half preclinical. And that, to answer your question, yes, I do think that some of these studies.., here, but just remember, they're not our studies. They belong to the clinical investigators of the academic investigators who are doing them. I can tell you, just as a broad statement, yes, you will see results from some of those studies this year. I do know where they are, particularly one which we were referring to. Relo Coraline Study and Process.

Cortisol modulators about half in the United States that have outside of the United States about half preclinical and clinical and now to answer. Your question, Yes, I do think that some of these studies will produce results. This year, but just remember they're not our studies they belong to the clinical investigators and the academic investigator.

We're doing them I can tell you just as a broad statement, yes, you will see results from some of the studies this year I do know where they are.

Particularly.

One, which would be referring to which railroad korlym study in prostate cancer.

Joseph Belanoff: I am, and you mentioned it, very, very interested in seeing the study results in the alcohol use disorder study which is being done at Scripps. So fingers crossed. I'm as anxious to see those results as you are and there's a broad range of them. So stay tuned. Thanks for taking the questions. We have our next question from Arthur from HC Wainwright. Please go ahead. Hey, good afternoon, gentlemen. This is Arthur in for RK.

It will be relatively soon but there are others I am and you mentioned it very very interested in seeing the study results in the alcohol use disorder study, which is being done at Scripps.

So fingers crossed on this <unk>.

He is anxious to see those results as you are and there's a broad range of them so stay tuned.

Thanks for taking the questions.

We have our next question from Arthur.

From H C. Wainwright. Please go ahead.

Hey, good afternoon gentlemen.

So we're in for RK.

Operator: Most of my questions have been answered. I just want to follow up on the MASH study. Could you guys give us an update on the enrollment status for this study and how many of those levels have been tested so far, and when could we expect to initially clean the data from the study? Thank you. Well, thank you for that question.

Most of my question has been answered.

I just want to follow up on the the match study could you guys give us an update on the enrollment status for this study.

How many dose levels have been passed so far.

And when could we expect the initial clinical data from this study. Thank you.

Unknown Executive: I really can't comment on the progress on each cohort. All I will tell you is the study is moving forward very well, with great screening and great enrollment activities for all of the different cohorts. And since this is an open label trial, we're evaluating data for each patient in each cohort as it progresses, and the plan is to finish this trial and all the co... Awesome.

Thank you for that question I really can't comment on the progress on each cohort all I will tell you is the strategy is moving forward very well with great screening and great enrollment activities for all of the different cohorts and since this is an open label trial, we are evaluating data for each patient in each cohort as it progresses.

And the plan is to finish this trial and all of the cohorts this year.

Awesome. Thank you.

Thank you Arthur.

We have our next question from <unk> <unk>. Please go ahead and please state your company name.

Unknown Executive: Thank you. Thank you. We have our next question from Taizeen Hamad, please go ahead and please state your company name. Hey, this is Leon Wang on for Tuzin.

Hey, this is Leon Wang on for <unk>, just a quick question.

Operator: Just a quick question. In terms of the some of the legal expenses that you mentioned as an OpEx driver in OneQ, can you get some more color on that? I mean, is this from IP or NDA? Or is this some other kind of legal expense that you are incurring?

In terms of the.

Some of the legal expenses that you mentioned that Opex driver. Once you can you give us some more color on that I mean is this.

From IP or Anda or is there some other kind of legal expense that you are incurring.

No it's nothing it's nothing new.

Unknown Executive: No, it's nothing. It's nothing new. You know, we're at the stage of, you know, we're producing information for the DOJ, class action lawsuit happens to be kind of the same. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, You know, that's what you're seeing this quarter.

The stage, we're producing information from the Doj class action lawsuit happens to be kind of in the same calendar phase.

So.

Yeah.

You didn't have people charging by the hour in a room looking through documents and doing email queries and you can really rack up a bill and Thats whats going on here, but once.

That's sort of a bolus of expense that we just have to work through them.

That's what you're seeing this quarter can't can't comment on future quarters that much because it's always a little bit unpredictable. How these things go but youre seeing that this quarter for sure.

Unknown Executive: Can't, you know, can't comment on future quarters that much because it's always a little bit unpredictable how these things go, but you're seeing that this quarter for sure. Okay, gotcha. So just for this quarter, you're expecting this, more bolus of a quarter versus maybe perhaps some future quarters coming up. Yeah, I mean, we will get through this set of expenses and that's all I can really say about it with any certainty. All right, thank you.

Okay Gotcha. So just for this quarter you are expecting this.

More bullish over quarter versus maybe perhaps some future quarters coming up.

Yes.

We will get through this set of expenses and Thats, all I can really say about it with any certainty.

Alright, thank you.

Yes.

Sure.

We have our next question from Alex Yao from My Watch New Please go ahead.

Operator: We have our next question from Alan Young from Biowatchnew, please go ahead. Hey, thanks for taking my questions. And Joe, it's good to hear from you again. Yeah. Hi, Alan. I'll ask a couple of different questions. I wanted to bring back Anody.

Hey, Thanks for taking my question then Joe it's good to hear from you again.

Yes Alan.

Hi.

A couple of different questions I wanted to bring back annuity.

Asked about the FTB two five mrna expression tests for GR receptor activity.

Operator: I want to ask about the FKB-P5 mRNA expression test for GI receptor activity. You feel like what you see and assuming all goes well, do you aim to market the test with a Reliquorlant commercial launch? Yeah, thank you for that question, Alan, just to, I know how closely you follow, but just for the rest. One of the things that we're really very interested in working on is seeing if we can come up with a more accurate test for cortisol activity than exists at the current time. In fact, there really are no... Cortisol Activity at this time, only cortisol level is measured. And Alan, I again, I just say this for the whole audience.

We still like what you see in assuming all goes well.

Came to market the test with a relic cortlandt commercial launch.

Yeah. Thank you for that question Alan.

Just two.

Know how closely you follow up just for the rest of the listeners.

The things that we're really very interested in working on the scene you can come up with the more accurate test of cortisol activity and exist at the current time back there really are no test for cortisol activity at this time only cortisol level as mentioned.

Joseph Belanoff: I don't I, you may be aware of it, but we have now published the results from, Surgical and Post-Surgical Study of FKBP5 in Patients with Cushing's, Now, you know. Unknown Attendee, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William, And so we think it's very important. We'll see where that shakes out.

Again, I would just say this for the whole audience.

You may be aware of it but we have now published the results from <unk>.

Surgical and post surgical study of <unk> in.

In patients with Cushings disease now.

Peer reviewed.

Strong journal.

But the most important thing to tell you is we collect that information the <unk> changes and all of the studies that we do.

And so we think it's very important we will see where that shakes out certainly an experiment.

Joseph Belanoff: Certainly an experiment, but it would be a terrific experiment because one of the things that any clinician will tell you is that patients can have severe Cushing syndrome with moderate levels of cortisol, and Moderate Cushing Syndrome with extraordinarily high levels, doesn't really match up. So, Our hope is that this measure will match up more accurately and be very useful to physicians. Will it be ready at the time that the ReliCorrel and NDA is submitted? I doubt it.

But it would be a terrific experiment because one of the things that any clinician, who will tell you is that patients can have severe cushing syndrome with moderate levels of cortisol excess and moderate Cushing syndrome with extraordinarily high levels of cortisol excess doesn't really match up so well.

Our hope is that this measure will match up more accurately it's very useful to physicians will be ready at the time that the <unk>.

Coral an NDA submitted I doubt it I think it is going to actually who state that but.

Joseph Belanoff: I think it's going to actually postdate that, but, you know, if you want to cross your fingers and assume that the results are good, I'm hoping it won't be too much behind that. So, you know, it's not going to be, if the question was, is it going to be part of what's needed for the NDA for ReliCorrel and Cushing Syndrome, it is not. It really is its own finding should it come to pass. How long is the phase length for CORT 125329?

If you want to crush fingers and assume that the results are good im hoping it won't be too much behind that so.

It's not going to be if the question was just going to be part of what's needed for the NDA for <unk> in Cushing syndrome. It is not it really isn't smooth finding should come to pass.

How does the phase one.

<unk> five three to nine.

Joseph Belanoff: Was it what you hoped, or is it just something that's put to rest for now? You know, Alan, I appreciate your understanding of all the detail we're in. Hazel Hunt, who is our really fantastic medicinal chemist and came up with all of these compounds, you know, has several compounds, you know, both preclinical and inclinical. I can tell you 1, 2, 5, 3, 2, 9, just you can file it away somewhere, is a potent glucocorticoid receptor modulator, where we take it uncertain at this point in time because, you know, as I've commented on before, after we find out that it really is the modulator. We then begin other biological assays to see where it can be best placed. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Thank you.

As you hoped or is it just something thats put to rest for now.

No.

Our 10 year.

Appreciate your understanding of all the detail or in <unk>.

Hunt, who is our really fantastic medicinal chemist and came up with all of these compounds has several compounds both preclinical and clinical.

I can tell you once you bought <unk>.

Deloitte away somewhere is a potent glucocorticoid receptor modulator, where we take it uncertain at this point in time, because as I commented on before.

After we find out that it really is the modulator that we hope it to be we then begin other biological assays to see where it can be best place in the past.

Apologies best in.

Metabolic diseases, and that's actually taking place right now.

Yeah.

Thank you looking forward to next quarter.

Yes, nice to talk to you again Alan.

I think this concludes all the people who had questions. So thank you very much.

For a detailed will obviously release information as we have it and we'll talk to you about three months from now.

Okay.

Ladies and gentlemen. This concludes today's presentation. Thank you for participating you may now disconnect.

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Thank you.

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Sure.

Okay.

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Good day and thank you for standing by welcome to the Carson Therapeutics Conference call.

Joseph Belanoff: Looking forward to your next quarter. Yeah, nice to talk to you again, Alan. I think this concludes all the people who had questions, so thank you very much for all the detail. We'll obviously release information as we have it, and we'll talk to you about three months from now. Ladies and gentlemen, this concludes today's presentation. Thank you for participating, you may now disconnect. Good day and thank you for standing by. Welcome to the Corcept Therapeutics conference call. At this time, all participants are in a listen-only mode.

At this time all participants are in a listen only mode.

Operator: After the speaker's presentation, there will be a question and answer session. And to ask a question during the session, you will need to press star 1 on your telephone keypad. And please be advised that today's conference is being recorded. Should you require further assistance, you may press star 0.

Turning to speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone keypad and please be advised that today's conference is being recorded. So you require further assistance in the press Star Zero and I will now turn the call over to Mr added back Macquarie CFO . Please.

Atabak Mokari: And I will now turn the call over to Mr. Atabak Mokari, CFO. Please go ahead. Good afternoon, and thank you for joining us. I'm Atabak Mokari, Corset's Chief Financial Officer. Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update. Copy is available at corset.com.

Go ahead.

Good afternoon, and thank you for joining US a lot of Mike Mccarthy of course, as Chief Financial Officer.

Today, we issued a press release announcing our financial results for the first quarter, providing a corporate update.

He is available at <unk> Dot com.

Atabak Mokari: Our complete financial results will be available when we file our Form 10-2. Today's call being recorded. A replay will be available at the investors past events tab of our, Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risk and uncertainty, which may cause actual results to differ materially from those such statements expressed or implied. These forward-looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q.

<unk> financial results will be available when we file our Form 10-Q with ITG.

Today's call is being recorded a replay will be available at the investors past events tab of our website.

Atabak Mokari: Please refer to those documents for additional information, to disclaim any intention or duty to update boards or committees. Our revenue in the first quarter was $93.7 million, an increase of 18% compared to the first quarter of last year.

Statements. During this call other than statements of historical fact are forward looking statements based on our plans and expectations and as such.

Like the rest of uncertainty, which may cause actual results to differ materially from those such statements expressed herein.

These forward looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K, and our quarterly reports on Form 10-Q.

Please refer to those documents for additional information.

Disclaims any intention or duty to update forward looking statements.

Our revenue in the first quarter with $93 7 million.

An increase of 18% compared to the first quarter of last year.

Atabak Mokari: As a reminder, each year, insurance reauthorization and coverage of our portion of the dome and hole gap in Medicare Part D coverage reduce our first quarter revenue. We expect our revenue growth to continue and have reiterated our 2022 revenue guidance of $400 to $430 million. Net income was $22.8 million, or $0.20 per share, in the first quarter, and our cash and investments increased $32 million in the first quarter to $368.1 million.

As a reminder, each year insurance reauthorization.

Coverage of our portion of the Donut hole gap and take care of part D coverage reduced our first quarter revenues.

We expect our revenue growth to continue and have reiterated our 2022 revenue guidance of $400 million to $430 million.

Net income was $22 8 million or <unk> 20 per share in the first quarter and our cash and investments increased $32 million in the first quarter to $368 1 billion.

Charlie Robb: March 30th, I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide an update on our litigation with generic manufacturers Teva and Hikla Pharmaceuticals. Charlie. Thanks, Atabak. There's little to report this quarter. As many of you know, Teva is seeking to market a generic version of Coraline in violation of our patent. In March 2018, we sued Teva in federal district court. That litigation is still underway. In the midst of our federal court litigation, Teva launched a parallel challenge to the validity of one of our patents, the 214 patent, in a procedure before the Patent Trial and Appeals Board, or PTAB, known as a post-grant review, or PGR.

Its 31.

I will now turn the call over to Charlie Robb, our Chief business officer to provide an update on our litigation with generic manufacturers and Hikma pharmaceuticals.

Charlie Robb: November of 2020, the PTAB rejected Teva's arguments of holding a 214 patent in its entirety, to have appealed this loss to the Federal Circuit Court of Appeals, where in December of 2021, it lost again. The matter is closed. Having lost the PGR, TEFCA can no longer challenge the 214 patent's validity in our district court case. Teva can only argue that his proposed products would not infringe, position we believe has no legal or factual, A year ago, we filed for summary judgment based on Teva's infringement of the 214 patent, have responded by filing its own summary judgment. Summary judgment is a procedure whereby courts can decide a case without holding a trial.

Sure.

Thanks, Dan Novak, there's little to report this quarter.

Charlie Robb: We believe the court has all it needs with respect to the 214 patent to decide the case in our favor, in which case it would be barred from marketing generic correlum until 2037 when the 214 patent expires. , and Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc, and Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc. All is quiet, which is, in some respects, unfortunate.

As many of you know Teva and <unk> in the market and generic version of Korlym in violation of our patents in March 2018, we sued Teva in Federal District Court that litigation is still underway.

The midst of our Federal Court litigation Teva launched a parallel challenge to the validity of one of our past the two one for Pat and procedure before the patent trial and Appeals board or <unk> known as a post grant review or PBR.

In November of 2020, the pits have rejected terms arguments falling into one four patents in its entirety.

Appeal this loss to the Federal Circuit Court of Appeals, where in December of 2021 has lost again Matt.

A matter is closed.

Having lost the PG or Kevin can no longer challenge the 214 patents validity in our district Court case, however, can only argue that as proposed product would not infringe.

We believe has no legal or factual support.

A year ago, we filed for summary judgment based on Kevin's infringement of <unk> patent.

And we responded by filing an sone summary judgment motion.

Murray judgment as procedure, whereby courts can decide the case without holding a trial.

We believe the court has all it needs with respect to the <unk> patents and decided the case in our favor.

Which case that would be barred from marketing generic core elements on 27, when the <unk> patent expires.

The court ruled in <unk> favor. We will proceed to trial most probably some time next year, although it is impossible to say certainly there's no timetable for the summary judgment ruling no trial date and no scheduled for any trial related activities. All this quiet, which is in some respects unfortunate.

This case has gone extremely well for us and we would like to wrap things up.

Charlie Robb: This case has gone extremely well for us, and we would like to wrap things up. In March 2021, we sued another antifiler, Hickman Pharmaceuticals. In this case, the court has set a fact discovery deadline of July 1 this year. Nothing is scheduled after that.

2021, we sued another anda filer, taking pharmaceuticals, and the same federal District Court. This hearing our case against Teva in this case. The court has set the fact discovery deadline of July one this year nothing is schedule after that.

Charlie Robb: With respect to both Teva and Hikma, we are very confident in the strengths of our league. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Thank you, Charlie. While we are getting closer to resuming our pre-pandemic way of life, some of the challenges posed by the pandemic have been the lack of access to health care. Even though recent COVID cases have tended to be mild, public health precautions taken by patients, physicians and our commercial team have made it more challenging for physicians to identify, diagnose and optimally treat all of their, and especially those with complex disorders such as Cushing's.

With respect to both Teva and Hikma, we're very confident in the strength of our legal position.

Charlie Robb: Hopefully these challenges will be completely behind us very soon. Despite residual effects of the pandemic, I want to stress how optimistic we are about the present and future of our Cushing Syndrome. This business is built on a strong foundation and effective life-saving medication promoted by a dedicated commercial team. Patients. Leading endocrinologists increasingly believe that there are substantially more patients with, And what's wrong with you? For many of these patients, Coraline is an excellent, As pandemic conditions and fears recede, we expect our growth to continue and we are reiterating our 2022 revenue guidance of $400 to $430 million.

I will now turn the call over to Dr. Joseph Belanoff, Our Chief Executive Officer, Joe <unk>.

Thank you Charlie.

While we are getting closer to resuming our pre pandemic lay up of late some of the challenges posed by the pandemic persists.

Even though recent COVID-19 cases, it tended to be mild public health cautions taken by patients.

<unk> and our commercial team has made it more challenging for physicians to identify diagnose and optimally treat all of their patients, especially those with complex disorders, such as Cushings syndrome.

Hopefully these challenges will be completely behind us very soon.

Despite residual effects of the pandemic I want to stress how optimistic we are about the present and future of our Cushing syndrome business.

Business is built on a strong foundation and effective lifesaving medication promoted by a dedicated commercial team with the interest of patients first.

Leading endocrinologist increasingly believes that there are substantially more patients with Cushings syndrome and was once assumed.

For many of these patients Korlym is an excellent treatment.

As pandemic conditions and fears recede, we expect our growth to continue and we are reiterating our 2022 revenue guidance of $400 million to $430 million.

We are also extremely optimistic about our clinical development programs. We have said for years that cortisol modulation has the potential to help treat many serious diseases.

The data generated by our ovarian cancer program provides evidence of cortisol modulations broad application.

2022, we will see important results for many of our other ongoing clinical programs.

These programs are examining the lead candidates from our portfolio of more than 1000 proprietary cortisol modulators, many of which are attractive candidates for developed.

Joseph Belanoff: Like Corallum, these compounds bind strongly to the glucocorticoid receptor, or GR. Unlikely. They have no affinity for the progesterone receptor, and so don't cause some of Corleum's most serious off-target effects. Beyond sharing the qualities of strong cortisol modulation and not perturbing the progesterone receptor, Preclinical and clinical testing have shown that our molecules behave differently from one another in important ways. Some cross the blood-brain barrier, others do not.

Like Korlym these compounds buying strongly to the glucocorticoid receptor GR.

Unlike korlym they have no affinity for the progesterone receptor and so don't cost seventh korlym as much serious off target effects.

So cross the blood brain barrier, others do not perform best in models of solid tumor others are more potent in models of metabolic disease.

Im appear to be tissue specific others have more global effects.

Joseph Belanoff: Some perform best in models of solid tumor, others are more potent in models of metabolic. Some appear to be tissue specific, others have more global effects. These diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders, including Ovarian, Adrenal, and Prostate Cancer, Antipsychotic Induced Weight Gain, NASH, and of course, Cushing's. We plan to start Phase 2 trial in patients with ALS early next quarter and have additional compounds in Phase 1 and preclinical development. Coraline's commercial success has provided the funds to advance all of these, and will continue to do so.

We plan to start phase II trial in patients with ALS early next quarter and have additional compounds in phase one in preclinical development.

<unk> commercial success has provided the funds to advance all of these programs and we'll continue to do so.

Our oncology program is testing three ANSI anticancer mechanisms first postulated by investigators at the University of Chicago and confirmed by other prominent researchers.

Joseph Belanoff: Our oncology program is testing three anti-cancer mechanisms first postulated by investigators at the University of Chicago and confirmed by other prominent, One mechanism is increasing apoptosis. Programs held that the chemotherapy is meant to induce insolid, Cortisol suppresses, Meaning cortisol works against the beneficial effect of chemotherapy. In our successful trial in women with advanced ovarian cancer, The addition of our Selective Cortisol Modulator, Reliquarolate, enhanced the effect of chemo, likely by blunting cortisol's anti-apoptotic effect.

One mechanism is increasing a pop ptosis programmed cell death that chemotherapy has mentioned solid tumors.

Cortisol suppresses epoch tests, meaning cortisol works against the beneficial effects of chemotherapy.

And our successful trial in women with advanced ovarian cancer the.

The addition of our selective cortisol modulator relic wireless enhance the effects of chemotherapy.

Likely by blending cortisol anti apoptotic effect.

Joseph Belanoff: While these patients' disease had progressed on two or more previous lines of treatment, Relochlorone appeared to resensitize some of these patients to the beneficial effects of chemotherapy. As a reminder, our Phase 2 trial was a controlled, multi-center study of 178 women with platinum-resistant ovarian cancer who were randomized to one of three treatment options. 60 women received a higher dose of Borrelia coralens on the day before, the day of, and the day after they received NAPPAC-Litaxil. 58 women received a lower daily Rilakkuma lint dose in combination with NatPak Litax. We call this the continuity.

While these patients disease had progressed on two or more previous lines of treatment rella coralline appear to re sensitize. Some of these patients the beneficial effects of chemotherapy.

As a reminder, our phase II trial was a controlled multicenter study of 178 women with platinum resistant ovarian cancer, who are randomized to one of three treatment arms.

<unk> women received a higher dose abroad Cortland on the day before the day and the day after they receive Nab Paclitaxel we call. This the intermittent.

58 women received lower daily Marella Cortland in combination with Nab Paclitaxel.

We call this the continuous.

Joseph Belanoff: And 60 women received NAP haplotaxil alone, we call this the comparator. The trial's primary endpoint was Progression-Free Survival, or PFS. The women who participated in our study were very ill, and including those with platinum refraction. All had experienced disease progression despite prior lines of therapy. All but one had progressed on prior courses of taxing this therapy. Their median number of prior treatments was three.

And 60 women receive Nab Paclitaxel alone we call this the comparator arm.

The trial's primary endpoint was progression free survival or PFS.

The women who participated in our study, we're very ill and including those with platinum refractory disease, all had experienced disease progression. Despite prior lines of therapy.

One had progressed on prior courses of Taxane based therapy.

Median number of prior treatments was three.

Joseph Belanoff: We presented the results from the study at the September 2021 European Society for Medical Oncology, ESMO, provided an update at our investor event in March. As these results clearly showed, Reliquorolin provides benefits to many of, Those who received Rellacorlin intermittently exhibited a statistically significant improvement in PFS compared to the group that received NAP-Paquitaxel monoclonal. Hazard Ratio in this group was 0.66 with a p-value of 0.05. The women in the intermittent arm also experienced a statistically significant improvement in duration of response relative to those in the comparator, with a hazard ratio of 0.36 and a p-value of 0.00. The women in the Intermittent Reliquorla group also lived long.

We presented the results from this study in the September 2021 European Society for medical Oncology, ESMO Congress and provided an update at our Investor event in March.

As these results clearly showed relatively orland provide benefits to many of these women.

Those are received rella correlate intermittently exhibited a statistically significant improvement in PFS compared to the group that received Nab Paclitaxel monotherapy.

Hazard ratio in this group was 26 six with a P value of <unk> three eight but.

Women in the intermittent arm also experienced a statistically significant improvement in duration of response relative to those in the comparator arm with a hazard ratio of <unk>, three six and a P value of 0.006.

The women in the <unk> group also live longer.

Joseph Belanoff: The hazard ratio for this group was 0.67 with a p-value of 0.065. Their median survival, or OS, for this group was 13.9 months, 1.7 months longer than for the NAP-Haclopaxil monotherapy group, which was 12.2 months. Importantly, safety and tolerability data for the women treated with ropes.

<unk> ratio for this group was <unk> seven with a P value of <unk> <unk>.

Their median survival OS for this group was $13 nine months, one seven months longer than that Nab, Paclitaxel monotherapy, which was $12 two months.

Shortly safety and Tolerability data for the women treated with <unk> plus Nab Paclitaxel was comparable to those who received Nab paclitaxel alone.

Joseph Belanoff: NAPAQLITAXEL was comparable to those who received NAPAQLITAXEL alone. We will share these results in an oral presentation at the American Society of Clinical Oncology Pasadena. Annual Meeting on June 6th in Chicago. Based on these positive results, we and our investigators are excited to conduct a phase three trial. Our Phase 3 trial design is very similar to the design of our Phase 2 trial with some standard modifications. For example, as is typical of late stage clinical trials, our phase three trial will exclude patients with either primary platinum refractory disease, patients who sadly never respond at all to the standard platform, and those who have received, have already received four or more prior lines of therapy.

We will share these results in an oral presentation at the American Society of clinical oncology Pascal.

Youll meeting on June six in Chicago.

Based on these positive results, we and our investigators are excited to conduct a phase III trial.

Phase III trial design is very similar to the design of our phase II trial with some standard modifications. For example, as is typical of late stage clinical trials, a phase II trial will exclude patients with either primary platinum refractory disease patients, who sadly never respond at all to the staff.

Platinum drug therapy, and those who've received more already received four or more prior lines of therapy.

Joseph Belanoff: Excluding such patients from the Phase 2 trial results produced an even greater differential improvement in progression-free survival, duration of response, and overall survival. Women in the intermittent arm experienced a statistically significant improvement in progression-free survival with a hazard ratio of 0.58 and a p-value of 0.016. Duration of response with a hazard ratio of 0.26 and a p-value of 0.001.

Excluding such patients from the phase two trial results produced an even greater differential improvement in progression free survival duration of response and overall survival.

Women in the intermittent experienced a statistically significant improvement in progression free survival.

Hazard ratio of <unk>, five eight and a P value 0.06.

Duration of response with a hazard ratio of <unk>, six and a P value of 0.001, and overall survival with a hazard ratio of <unk>, two and a P value of points Youre alon relative to patients who receive Nab paclitaxel.

Joseph Belanoff: And overall survival with a hazard ratio of 0.52 and a p-value of 0.01 relative to patients who received NAPAQLITAX alone. We have received very positive feedback from leading gynecologic oncologists regarding the promise of relacorlin as a treatment for women with this desired disease. In their view, relacorlin's potential benefits improve survival without increased side effects, constitute an important medical event. They feel that the RelaCoral and PlusNav Paclitaxel has the potential to become a new standard of care in the area. We have designed and will conduct our phase three trial with advice from two leading researchers. The Gynecologic Oncology Group in the United States and the European Network of Gynecological Oncology Trials Group in Europe.

We have received very positive feedback from leading gynecologic oncologists regarding the promise umbrella korlym as a treatment for women with this desire disease.

Our view <unk> as a potential benefit improved survival without increased side effect burden will constitute an important medical advance.

They feel that <unk>, plus Nab paclitaxel has the potential to become a new standard of care and ovarian cancers.

We have designed and we will conduct our phase III trial with advice from two leading research group the gynecologic oncology group in the United States and the European Network of Gynecological oncology trials group in Europe , most of our investigators will be drawn from these groups we.

And members of the Gynecologic oncology group will meet with the FDA in June to discuss the optimal path forward and we will initiate our phase III trial shortly thereafter.

Second mechanisms by which cortisol modulation may prove useful is by blocking an important tumor growth pathway.

Joseph Belanoff: Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape. We recently completed enrollment in our dose-finding study of our Selective Cortisol Modulator X. Combined with enzalutamide and minimum castrate resistant prostate. Investigators at the University of Chicago are conducting a similar study of urella chloraline combined with enzalutamide in the same patient population.

Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route.

We recently completed enrollment in our dose finding study of our selective cortisol modulator <unk> combined with and solidified in men with castrate resistant prostate cancer.

Investigators at the University of Chicago are conducting a similar study relevant wireless combined with and solidified in the same patient population.

Joseph Belanoff: We expect to select an optimum dose to be the rela-correlant or exa-correlant to take forward the, The third mechanism seeks to reduce cortisol suppression of the immune system. Quality of cortisol that likely blunts the effectiveness of immunotherapy. We are conducting an open-label phase 1b trial, abrella correlant, plus the PD-1 checkpoint inhibitor, pembrolizumab, Merck's drug, Keytruda, in patients with advanced adrenal cancer whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and could, A Usual Quickly Lethal Combination, Pembrolizumab is rarely effective as monotherapy in these patients.

We expect to select an optimum dose of either <unk> or <unk> to take forward this quarter.

A third mechanism seeks to reduce cortisol suppression of the immune system.

Quality of cortisol likely once the effectiveness of immunotherapy.

We are conducting an open label phase one b trial umbrella Cortland, plus a PD one checkpoint inhibitor <unk> merck's drug keytruda in patients with advanced adrenal cancer, whose tumors produce excess cortisol.

These patients suffered the effects of adrenal cancer and Cushings syndrome, a usual quickly lethal combination.

Kimberly listen that is rarely effective as monotherapy in these patients. We believe that these patients cortisol excess maybe countering the intended effects September Elizabeth App, which is to stimulate the immune system.

Joseph Belanoff: We believe that these patients' cortisol excess may be countering the intended effects of Pembrolizumab, which is to stimulate. Our trial is evaluating whether Rella Chloraline can treat these patients' Cushing syndrome by reducing excess cortisol activity and, by reversing cortisol-induced immune suppression, allow Pembrolizumab to achieve its full cancer-killing effect.

Our trial is evaluating with the relic orland and treat these patients cushings syndrome by reducing excess cortisol activity and by reversing cortisol induced immune suppression allow <unk> to achieve its full cancer, killing effects.

Joseph Belanoff: We plan to enroll 20 patients at 7 sites in the United States. The primary endpoint of this study is objective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival. I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator, Miracle, and patients with NASH, serious liver disorder. Patients who received MiraCorrelent in our Phase 2 trial exhibited large rapid reductions in liver, but also substantial transient elevations of the liver enzymes ALT.

We plan to enroll 20 patients at seven sites in the United States. The primary endpoint of this study is objective response rate with secondary endpoints, including progression free survival duration of response and overall survival.

I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator mirror correlate to patients with Nash serious liver disorder.

Patients, who received mirror Cortland and our phase II trial exhibited large rapid reductions in liver fat, but also substantial transient elevations of liver enzymes ALC ASD.

Joseph Belanoff: The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected, and are rarely seen over any period of treatment. As a reminder, our trial's primary endpoint was a 30% reduction in liver fat after 12 weeks. In fact, patients exhibited reductions ranging from 38.5% to 73.8% after receiving Miracloraline for just a month. It may be that the rapidity of Miracoral and SPAT reducing effect caused the patient's ALT and AST to rise. One way the liver sheds fat is by metabolizing it into fatty acids, and excessive amounts irritate.

The improvement in liver fat in these patients was greater and a much more rapidly than we had expected and are rarely seen over any period of treatment as.

As a reminder, our trial's primary endpoint was at 30% reduction in liver fat. After 12 weeks of treatment in fac patients exhibited reductions ranging from 38, 5% to 73, 8% after receiving mirror correlate for just a month.

And maybe that the rapidity amira correlates bat, reducing effect caused the patients ALC and Asps rise one way the labor shifts that despite metabolized into fatty acids, which is in excess of amounts irritate the liver.

David Amsellem: David Amsellem, David Amsellem, David Amsellem, Interestingly, lipids in the blood of these patients did not increase. Providing support for the idea that mirapolrolant caused their excess fat to be metabolized immediately within the, The goal of our Phase 1b dose-finding trial of patients with presumed NASH is to identify a dosing regimen. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, We're also evaluating miracoralline as a potential treatment for patients with another serious and widespread, Antibiotic, Antipsychotic Induced Weight Gain.

Interestingly lipids in the blood of these patients did not increase providing support for the idea that Europe , Poland caused their excess fat to be metabolized immediately within the liver.

All of our phase <unk> dose finding trial in patients with presumed Nash is to identify a dosing regimen that significantly reduces back without causing excess.

Liberty irritation.

We're also evaluating their korlym as a potential treatment for patients with another serious and widespread disorder anti psychotic anti psychotic induced weight gain.

David Amsellem: In the United States, 6 million people take antipsychotic medications such as lansipine and risperidone. Treat Illnesses Including Schizophrenia, Bipolar Disorder, and Depression. While these drugs are very effective, they exact steep price in the form of rapid and sustained weight gain, which leads to cardiovascular and metabolic disease.

States 6 million people take anti psychotic medications, such as Olanzapine and risperidone to treat illnesses, including schizophrenia bipolar disorder and depression.

While these drugs are very effective the exact steep price in the form of rapid and sustained weight gain which leads to cardiovascular and metabolic disease.

Joseph Belanoff: The average life expectancy of patients in the United States who chronically take antipsychotic medication, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc, Such as heart attacks and strokes. We are conducting two double-blind placebo-controlled phase 2 trials of miracloraline in patients with this disorder. Gratitude and Gratitude 2, both of which I'm pleased to say are now fully enrolled. These trials seek to build on the positive data from our study of mirror-correlant in healthy subjects. 2020, we completed a trial in which 96 healthy subjects received a, and either 600 milligrams of Miracorland, 900 milligrams of Miracorland. We'll see you both in 14 days.

The average life expectancy of patients in the United States, who chronically take anti psychotic medication is decreased by 20 years frequently due to increased cardiovascular events, such as heart attacks and strokes.

We are conducting two double blind placebo controlled phase II trials of <unk> in patients with this disorder.

Gratitude and gratitude to.

Both of which I'm pleased to say are now fully enrolled.

These trials seek to build on the positive data from our study of <unk> in healthy subjects. In 2020, we completed a trial in which 96 healthy subjects received olanzapine and either 600 milligrams of mirror Orland 900 milligrams.

Or placebo for 14 days.

Joseph Belanoff: Subjects who received miracorrelant gained significantly less weight than those who received placebo. They also exhibited a smaller increase in triglycerides and an ALT and an AST, which typically exhibit sharp transient increases at the start of a lansipine therapy. Paper describing these results was published in the Journal of Clinical Psychopharmacology, The GRATITUDE trial is evaluating whether miraclorelin can reverse recent antipsychotics. Patients with schizophrenia or bipolar disorder receive, in addition to their established dose of anti-psychotic medication, either 600 milligrams of marijuana or placebo for 12 weeks.

Subjects, who received mirrored correlate gained significantly less weight and those who received placebo.

We also exhibited a smaller increase in triglycerides and in ALC and <unk>.

Asti, which typically exhibit sharp transient increases at the start of Olanzapine therapy.

A paper describing these results was published in the journal of clinical Psychopharmacology.

The gratitude trial is evaluating <unk> can reverse recent antipsychotic induced weight gain.

<unk> with schizophrenia or bipolar disorder received in addition to their established dose of anti psychotic medication, either 600 milligrams of <unk> or placebo for 12 weeks.

Joseph Belanoff: Gratitude is being conducted at 30 centers in the United States. Our Gratitude II study is testing miracloraline as a treatment for long-standing antipsychotic, Patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams or 900 milligrams of miracorrelant or placebo for 26, Gratitude II is being conducted at 35 centers in the United States. The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be, We look forward to the data readouts from these trials in the fourth quarter.

Our attitude is being conducted at 30 centers in the United States.

Our gratitude two study is testing mirror korlym as a treatment for long standing antipsychotic induced weight gain patient.

Patients with schizophrenia will receive in addition to their established dose of anti psychotic medication.

600 milligrams or 900 milligrams of <unk> or placebo for 26 weeks.

We look forward to the data Readouts from these trials in the fourth quarter. If the results are positive we plan to advance our program to phase III next year.

Joseph Belanoff: If the results are positive, we plan to advance our program to phase three next week. As most of you know, roaquarelant is our planned successor to Quorola for the treatment of hypercortis, We are evaluating two Phase 3 trials, GRACE and GRADIENT. Like all of our proprietary molecules, Relocorrelant is a selective cortisol module. Like Chorla, it achieves its effect by competing with cortisol and the glucocorticoid receptor. Unlike, does not bind to the progesterone receptor, PR for short. It is not the abortion pill, and it does not cause other PR-related side effects, including endometrial thickening and vaginal bleeding.

As most of you know <unk> is our planned successor to Korlym for the treatment of hyper cortisol.

We are evaluating two phase III trials Grace and gradient.

Like all of our proprietary molecules relative orland is selective cortisol modulators like korlym. It achieves its effect by competing with cortisol at the glucocorticoid receptor.

Unlike korlym it does not bind to the progesterone receptor PR for short it is not the abortion pill and it does not cause other PR related side effects, including endometrial thickening and vaginal bleeding.

By a different mechanism relative orland also does not appear to cause hypokalemia low potassium.

Serious side effects experienced by 44% of patients can korlym as a pivotal trial.

Korlym induced hypokalemia is a leading cause of korlym discontinuation.

Relative Orleans phase II efficacy and safety data were strong.

Joseph Belanoff: Relic Orleans Phase 2 efficacy and safety data were strong. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing's syndrome. There were no reliquorrelent-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced hypokalemia.

Patients experienced meaningful improvements in hypertension, and glucose control as well as in a variety of other signs and symptoms of Cushing syndrome.

There were no relevant induced instances of endometrial thickening or vaginal bleeding and no drug induced hypokalemia.

Joseph Belanoff: The trial results were published in Frontiers in Endocrinology. Our GRACE trial has a planned enrollment of 130 patients with any etiology of cushioning. As a reminder, Grace has a randomized withdrawal trial. All patients receive Reliquor Lint for 22 weeks in an open label.

Trial results were published in frontiers in endocrinology.

Grace trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome.

As a reminder, grace is a randomized withdrawal trial design all patients receive <unk> for 22 weeks in an open label phase those who meet response criteria for improvement in glucose control hypertension or bulk are randomized to continue treatment with <unk> or placebo for 12 weeks.

While the pandemic had a real impact on the execution of this trial, we and our investigators are eager to take rates to the finish line, we expect grades to serve as the basis for our NDA submission in Cushings syndrome, which we now expect to submit in the second half of 2023.

Our second phase III trial gradient studying relative Orleans effects in patients, whose cushings syndrome is caused by an adrenal adenomas or adrenal hyperplasia.

Patients with this etiology of Cushing syndrome, often experience a less rapid decline, but ultimately their health outcomes are poor.

Joseph Belanoff: Gradient has a planned enrollment of 130 patients and is being conducted at many of the sites participating in GRADE. Gradient is the first controlled study in patients with this type of crushing, While we do not expect our NDA and Cushing syndrome to depend on data from grade We do expect that its findings will help improve the care of these increasingly recognized, Finally, a brief word about data, which has shown great promise in animal models of ALS.

Gradient has a planned enrollment of 130 patients and is being conducted at many of the sites participating in grace.

Gradient is the first controlled study in patients with this type of Cushing syndrome.

While we do not expect our NDA Cushing syndrome and on data from gradient. We do expect that its findings will help improve the care of these increasingly recognize patients.

Finally, a brief word about data to correlate which has shown great promise in animal models of ALS.

Yes.

Joseph Belanoff: We are on track to initiate a Phase 2 trial early next quarter. This study is being shepherded by TRITALS, the leading ALS academic consortium in Europe. We will have more to say as that trial gets underway. We expect our commercial growth to continue as pandemic conditions recede. Remember, even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.

We're on track to initiate a phase two trial early next quarter. This.

This study is being shepherded by try counts the leading AOS academic consortium in Europe , we will have more to say as that trial gets underway.

We expect our commercial growth to continue as pandemic conditions received.

Remember even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities.

Joseph Belanoff: We believe cortisol modulation can help treat many serious disorders. I believe for which our development programs are now providing a growing body of, Coraline and Relacoraline for patients with Cushing syndrome provide an easy-to-see example of cortisol modulation's benefits. The data generated by our ovarian cancer program provides a good example of cortisol modulation's broad application.

We believe cortisol modulation can help treat many serious disorders.

I believe for which our development programs are now providing a growing body of evidence.

Korlym and <unk> for patients with Cushings syndrome provide an easy to see example of cortisol modulations benefits.

The data generated by our ovarian cancer program provides a good example of cortisol modulations broad application.

Joseph Belanoff: 2022 opened with strong overall survival results in our phase two trial of adjunct urilla coral and platinum-resistant ovarian cancer. The remainder of 2022 will provide results from other important, Cortisol Modulation Portfolio. In particular, NASH and antipsychotic-induced weight, Both are following up on extensive preclinical and encouraging early clinic.

2022 opened with strong overall survival results in our phase II trial of adjunctive <unk> correlate in platinum resistant ovarian cancer the.

The remainder of 2022 will provide results from other important programs and our cortisol modulation portfolio.

In particular, Nash and anti psychotic induced weight gain.

Both are following up on extensive preclinical and encouraging early clinical results we.

Joseph Belanoff: We're also excited to start a phase two trial using another of our proprietary, compounds, dazzling. We treat patients with ALS. Last but not least important, additional proprietary compounds are advancing. This is an exciting time.

We are also excited to start a phase II trial using another of our proprietary compounds dazzle korlym to treat patients with ALS.

Last but not least important additional proprietary compounds are advancing towards the clinic.

This is an exciting time of course yet.

Joseph Belanoff: I'd like to thank our employees for their tremendous effort and dedication. We recently announced three key additions to our commercial and development leadership, and are expanding our teams more broadly to support what we believe is an incredibly broad and strong pipeline and a substantial commercial opportunity. I'll stop here for, Thank you, presenters. At this time, for the participants, you may press star one on your telephone keypad, and if you would like to withdraw your question, you may press the pound key.

To thank our employees for their tremendous effort and dedication we recently.

We announced three key additions to our commercial and development leadership teams and are expanding our teams more broadly to support what we believe is incredibly broad and strong pipeline and a substantial commercial opportunity.

Stop here for questions.

Thank you presenters at this time for to participate you May press star one on your telephone keypad.

And if you would like to withdraw your question you May press the pound key.

Operator: Please pause for just a moment to compile the Q&A roster. We have our first question from Matt Kaplan from Leidenberg, please go ahead. I congrats on the quarter and strong results. I just wanted to focus a little bit on Reliquoil and Cushing's and the grace and gradient studies. Given your new guidance, how should we think about how long it should take to prepare an NDA to file in the second half of 23? Is that roughly a six-month process or something like that?

Can you quantify or give us a moment to compile the Q&A roster.

Okay.

We have our first question from Matt Kaplan from Ladenburg. Please go ahead.

Hi, congrats on the quarter strong results on that.

Just wanted to focus a little bit.

Well equivalent and.

Cushing and Grace and greatest studies.

Given your given your new guidance, how should we think about.

How long it should take to the parent NDA.

To file in the second half of two.

'twenty three.

Is that is that roughly a six month process or something like that.

William Guyer: Well, just to introduce an important voice in the room, I'd like to reintroduce you to Bill Guyers, who's our Chief Development Officer, to take that question. Since we are planning for an NDA in the second half of 2023, approximately four to six months prior to that we should have completed the study and then allow us to prepare for that, Okay, okay, that's helpful. And, and in terms of gradient, where, how is that progressing? And in terms of enrollment? Graded study is enrolling in parallel to that of GRACE, so very similar. Okay, so kind of on a parallel path on a parallel path.

We're just doing it to introduce.

An important voice in the room I'd like to reintroduce you to Bill Guy or two that Chief development officer to take that question Les but in the rest of my voice for a little bit alright. Thank you. Thank you for that question since we're planning for an NDA in the second half of 2023, approximately four to six months prior to that we should have completed the study and.

Then allow us to prepare for that NDA.

Okay. Okay, that's helpful and in terms of gradient.

How is that progressing.

In terms of enrollment.

Great Aunt <unk> study is enrolling in parallel to that of great. So very similarly.

Okay, so kind of.

On a parallel path unparalleled yes.

Okay great.

And.

And then in terms of.

Unknown Executive: Yes. Great. And, And then in terms of the metabolic program, metabolic disease program, is in terms of the phase two data for both of the, both of the studies that are expected in the second half of this year in the fourth quarter. What would you need to see to get excited there to move into phase three in 23?

The metabolic.

Metabolic program at.

At about this.

Program.

Yes.

In terms of the phase II data for both of the.

Both of the studies that are expected in the second half of this year in the fourth quarter.

What what would you need to see to get excited there too.

To move into phase III.

And 'twenty three.

Unknown Executive: Unknown Attendee, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, We're going to see a lot of data from both of these trials and learn a lot after we've analyzed the data to determine their implication. You know, as we learn from this data set, we're going to primarily focus, as Joe said earlier, on evaluation of weight changes for mirror correlant at different doses versus that of placebo, as well as other metabolic factors that we're going to be evaluating in this study compared to, So it's that collection of overall data set of weight changes and metabolic factors, will really help guide us forward on the next steps forward of how to proceed to phase three.

Okay anti psychotic weekend anti Scott.

It's a great I mean, there are many patients with anti psychotic induced weight gain and this is the first time that we've ever done this important experiment.

We're going to see a lot of data from both of these trials and you learn a lot and we've analyzed the data and determine their implications.

As we learned from this data set we're going to primarily focus as Joe said earlier on.

Evaluation of weight changes for mirror Korlym.

<unk> doses versus placebo as well as other metabolic factors that we're going to be evaluated in this study compared to that.

So with that collection of overall data set of weight changes in metabolic factors that will really help guide us forward on the next steps forward of how to proceed to phase III next year.

Okay great.

Unknown Executive: Okay, great. Well, thanks for taking the question. We have our next question from Chris Howerton from Jeffreys, please go ahead. Great. Thanks so much for taking the questions. I think maybe I'll start with thinking about the revenue guidance that you provided this year. Relative to the first quarter performance, you're going to have to have the best three quarters that you've ever had in order to meet those guidance.

Thanks for taking my question.

Yes.

We have our next question from Chris Howerton from Jefferies. Please go ahead.

Great. Thanks, so much for taking the question.

I think maybe I'll start with thinking about the revenue guidance that you provided this year.

Yes no.

Sean Maduck: So I guess, what gives you the confidence that you'll be able to achieve that? Yeah, no, I understand the question. And again, like to reintroduce you to Sean Maduck, who was the president of our endocrinology. Yeah, thanks for the question. And I want to just sort of reiterate what was said in the comments and what Joe had said previously that and we are reiterating our guidance. We'll talk a little bit about just the first quarter in particular.

I understand the question and again like to reintroduce you to Shama, Duke who was the president of our Endocrinology Division.

Yes, thanks for the question.

I wanted to just sort of reiterate what was said in the comments on what Joe had said previously and we.

Our reiterating our guidance.

Felipe.

We remain on track for that we'll talk a little bit about just the first quarter in particular.

Sean Maduck: There's a couple of things that occurred in that. There's the expected and the onyx- Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, More free drug, but not fewer patients. So I'd say that's the expected piece of it.

A couple of things that occurred and that there is the expected and unexpected.

The expected out of Ark mentioned in his opening remarks every January we see challenges in the areas of insurance coverage.

Coverage and.

And we make sure the treatment is not interrupted for patients we provide free drug until that paid coverage resumes and that leads to.

More free drug, but not pure patients on medicine. So I'd say, that's we expect that piece of it the unexpected piece that affected us in Q1.

Sean Maduck: The unexpected piece that affected us in Q1 was increased COVID's concern. So in Q4 and then the first half of Q1, the Omicron surge created disruption to our business, some disruption. I would say practices were closed again like they were earlier in the year and it was hard for our clinical specialists to get in and patients were also hesitant to actually go and see their doctors, which is necessary for appropriate screening.

<unk> was increased cobot is concerned so Q4 and then the first half of Q1, the omicron surge created disruption to our business. Some disruption I would say practices were closed again like they were.

Sean Maduck: And in addition to that, the first time during this COVID window, our team was affected, multiple members of our field force were actually actually caught the virus and had to be out of the field, which which limited their time. I've talked about this in the past, but it takes many interactions with a clinical specialist before a physician goes from core limb naïve to actually prescribing their first prescription. And the lag effect of both the Omicron surge and the limited field time had an impact on, So, you know, all that being said, Omicron came and it went pretty quickly and things are really starting to return to normal and we're optimistic that improvement is going to continue, why we feel confident in the next. And just Chris, you know, because I do want to emphasize and your math is absolutely correct. In order to meet our revenue guidance, we have to have the best course that we've ever had.

Concerning position so.

I've talked about this in the past, but it takes many interactions with a clinical specialist before a physician goes from korlym naive to actually prescribing there.

And the lag effect of both of.

Because I do want to emphasize your math is.

Absolutely correct in order to meet our revenue guidance, we have to have the best quarters that we've ever had and that is our expectation.

Okay, Alright, that's awesome.

Bill Guyer: And that is our, Okay, I mean, that's awesome. Okay, and then, if I may, on the ovarian cancer phase three trial, I could totally have this wrong, but my understanding is that experimental agents in combination need to be studied separately first. And I guess, what are your expectations of how the FDA is going to treat, you know, NADPAC or Taxol, given that it doesn't have a label in ovarian cancer going into that study? Thank you for that question. This is Bill Guyer.

Okay, and then if I may on the ovarian cancer phase III trial.

Could totally have this wrong, but my understanding is that experimental agents in combination needs to be studied separately first and I guess what are your expectations of how the FDA is going to treat.

Paclitaxel given that it doesn't have a label in ovarian cancer going into that study.

Yes.

Bill Guyer: So when it comes to napaclitaxel, there is a wealth of research that has gone along with napaclitaxel in ovarian cancer. With that package, I think that helps us since this isn't just the first time we've ever studied it, we're adding to that body. The other key piece is those who have done the studies with NAPAQUA-Taxel primarily were the gynecological oncology organization, the GOG.

Okay. Thank you for that question. This is Doug are so when it comes to Nab Paclitaxel. There is a wealth of research that is Scott along with Nab Paclitaxel in ovarian cancer. So with that package I think that helps us since this isn't just the first time, we've ever studied it we're adding to that body of research.

Other key pieces, those who have done the studies with Nab Paclitaxel, primarily were the gynecological oncology organization, the Geo cheap and they are the people, who we partner with to help us with the FDA and they have a wealth of experience in working with the FDA to shepherd drugs through phase III, but also to get drugs approved through.

Bill Guyer: And they are the people who we partnered with to help us with the efforts. And they have a wealth of experience in working with the FDA to shepherd drugs through phase three, but also to get drugs approved through the FDA. We feel very confident that what we've designed in our trial will move forward very expeditiously.

The FDA, so we feel very confident that what we've designed in our trial.

We'll move forward very expeditiously. In addition, we're going to be talking with the FDA This quarter and so we will seek their guidance I'm very shortly.

Bill Guyer: In addition, we're going to be talking with the FDA this quarter, and so we will seek their guidance very shortly. But we still plan to initiate the phase three study. Okay, all right. Well, thanks so much. And then I guess, if I may, if you'll let me on the last one for the GRACE trial, I think point taken in terms of the COVID impacts on enrollment, but I actually can't remember what the sites were. Is there any impact of the the unfortunate war conflict that we're having on enrollment? Or would there be any impact of loss to follow up potential?

But we still plan to initiate the phase III study this quarter.

Okay, alright, well, thanks, so much and then I guess.

If I may if you let me on the last one for the Grace trial.

I think point taken in terms of the COVID-19 impacts in enrollment but.

I actually can't remember what the sites where is there any impact of the unfortunate where conflict that we're having on the enrollment or.

Would there be any impact of lost to follow up potential.

Bill Guyer: Yeah, you know, it's interesting because you're the first person to ask that question. And it's a good question, you know, because we actually I can tell you at the beginning of the study had actually considered, having sites in Ukraine. Luckily, did not happen, at all.

Yes.

It's interesting because you're the first person to ask that question.

Good question, because we actually I can tell you at the beginning of the study had actually considered.

Having sites in Ukraine, and just I guess in hindsight.

Right.

Luckily did not have that they're sort of at the all the problems that exist in that country.

Bill Guyer: So far, we really haven't seen that as much of an issue. Last week, we were at, A very well attended investigator meeting in Europe, and we didn't really hear any feedback about that being a problem at all. So I'm going to say no, it has not. But, you know, of course, the future over there is far less certain than we'd like it to be. But no, at this point, no issue. And we certainly would talk, Awesome.

So far we really haven't seen that as much of an issue last week we were at.

Very well attended investigator meeting in Europe , and we didn't really hear any feedback about that being a problem at all so I'm going to say no. It has not but of course the feud.

Future over there is far less certain than we'd like it to be but no at this point no issue.

We certainly would talk about it.

<unk> became an issue.

Awesome, Okay, alright, well thanks for all the answers to my questions and congratulations on the progress so far.

Bill Guyer: Okay. All right. Well, thanks for all the answers to my questions and congratulations on the progress so far. You're welcome, Chris.

You're welcome Chris Thank you.

We have our next question from Edward Nash from Canaccord Genuity. Please.

Operator: Thank you. We have our next question from Edward Nash from Canaccord Dignity. Please go ahead. Hi. Hi, guys.

Please go ahead hi.

Hi, guys. Thanks for taking my question and I Hope you guys are doing well.

Operator: Thanks for taking my question. I hope you guys are doing well. One of the states, there's been any updates in the New Jersey AG investigation. Have they requested anything beyond the original inquiry to date? I'm going to turn you back over to Charlie.

What are the thing I'd say, it's been any updates in the New Jersey AG investigation have they requested anything beyond the original inquiry to date.

I'm going to turn you back over to Charlie Robb.

Charlie Robb: So the answer is that the nature of these investigations generally is that they start with initialist stuff and there's sort of some fluid back and forth. But I really have nothing to announce about that investigation right now. But I think that maybe the more interesting thing I can say is that I regret having... Let me just provide a little bit of context so you can understand why I'm saying that.

Okay, So, yes, hi, Ed.

So the answer is that.

The nature of these investigations generally is that they start with.

Initial of stuff in there.

Fluid back and forth, but really have nothing to announce about that an investigation right now.

But I think the.

More interesting I can say is that I regret having nothing to announce about the investigation, so far and let me just provide a little bit of context.

Understand why I'm, saying that which is that the.

But for those who don't follow this as closely what is referring to is.

Charlie Robb: What Ed's referring to is a request for information that we received from the DOJ, a subpoena back in November of last year. As we announced then in our doing, we said we would cooperate with their inquiry, which we're certainly doing, and our approach is to provide them with the information that they want as fast as we can, and always faster than they're able to avoid. And why is that? The reason is we really want to stay ahead of them.

A request for information that we received from the FCC.

Doj subpoena.

Peanut back in November of last year, as we announced then and are doing we said, we would cooperate with their inquiry, which we're certainly doing and our approach is to provide them with the information that they want as fast as we can and always faster than they're able to absorb.

And why is that.

The reason is we really want to stay ahead of them. We always have information from us to review, because that's where you move things along as expeditiously as possible.

Charlie Robb: We want them to always have information from us to review because that's the way you move things along as experts. As, These, the DOJ is staffed by public servants who are interested in the truth, and the truth for us is our friend.

Inquiry, although not indirectly causally linked in any way, but is it in some way sort of the culmination.

Short seller allegations class that turned into a class action lawsuit that were litigated now.

And now we have this Doj inquiry and the reason I welcome speed and expeditious resolution in that cases these.

This is the Doj is staffed by public servants, who are interested in the truth.

And the truth for US is our friend and so I wanted to get our story in front of them as fast as we possibly can.

Charlie Robb: And so I want to get our story in front of them as fast as we possibly can, because I think that is how we will put this all behind us happily and be able to move forward without this distraction. So, I wish there was something to say. There will be something to say in the future, but right now there's. That's great. No, I appreciate that detail.

Because I think that is how we will put this all behind us happily and be able to move forward without distraction. So I wish there was something that there.

There will be something as say in the future, but right now there's really nothing to add.

That's great and I appreciate I appreciate that detail and then just my last question is just regarding your correlate.

Charlie Robb: And then just my last question is just regarding your correlant in antipsychotic induced weight gain. So how do you think about patient characteristics of those with recent versus longstanding weight gain? I mean, are they are there any differences in metabolic parameters between each group?

How they can do weight gain so how do you think about patient characteristics of those with recent versus long standing weight gain.

Are there any differences in metabolic parameters between each group do you think the patient.

Charlie Robb: Do you think the patients with longstanding AWIG have achieved homeostasis with regard to metabolic parameters after weight gain? And does that impact your thoughts on on the potential duration of treatment for the patients versus recent AWIG? Yeah, it's a very good question. I've gotten that one either, but really it's an opportunity for me to talk a little bit about it. Patients who take antipsychotic medications, and I can tell you, Describes them, tend to gain weight very quickly, and it is often very difficult to get to the matter what, at www.swayampakula.com.

With long standing.

Have achieved homeostasis with regard to metabolic parameters after weight gain and does that impact your thoughts on on the potential duration of treatment for the patient versus recent haywood.

Yes.

Very good question.

I haven't gotten that one either but.

Really it's an opportunity for me to talk a little bit about it.

Patients, who take anti psychotic medications and I can tell you with someone who prescribes them tend to gain weight very quickly and it is often very difficult for them to lose it.

What they do over time and yet they have to take their antipsychotic medication.

As I sort of think about patients with schizophrenia.

Ruefully say the worst thing a patient with <unk>.

Charlie Robb: What schizophrenia can do is not take their medication. And the second worst thing they can do is take their medication, because these medications really do cause serious, serious metabolic problems. And yet for the purpose, very good at.

Schizophrenia can do is not take their medication.

Second worst thing they can do is take their medication.

These medications really do cause serious serious metabolic problems and yet for the purposes are very good at.

Charlie Robb: Producing psychosis, they're quite effective. So we're doing the study, you know, I know no one's ever done in some sense either of these two studies, which is, can you reduce the weight gain cost? Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc or take a look at the other group of which the numbers in the United States, you know, are really ample of patients who have taken antipsychotic medication for a long time and have substantial weight gain, you know, but are but are little Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, So I don't know what the results of these studies are gonna be.

Reducing psychosis they are quite effective.

So we're doing the study no one's.

Never done since is either of these two studies, which is can you reduce the.

Gain caused by anti psychotic medication at all and sort of the new the early study of people, who you can really track to the very beginning when they began their anti psychotic medications within the last six months can you actually takeaway that weight gain or take a look at the other group of which the numbers in the United States.

We are really ample of patients who have taken anti psychotic medication for a long time and have substantial weight gain but but are a little.

Potentially a little less specific to the anti psychotic medications because they are there.

Life in America American died and so on and so forth. So.

I don't know.

With the results of these studies are going to be obviously I have a hypothesis that our medicine will be beneficial for both of those groups, but as bill mentioned before much data that come and it's going to be very very interesting both for us and for the field to see if we can really do something about this problem, whether it's a short term problem or a long term.

Problem, it's a big problem and I really look forward to seeing that.

Turning over to cards. These blinded studies.

Great. Thanks, so much really appreciate the color there and look forward to a strong the next three quarters. Thank you.

Thanks.

Yes.

We have our next question from Greg <unk> from <unk> Securities. Please go ahead.

Charlie Robb: Look forward to a strong next three quarters. Thank you. Thanks. We have our next question from Greg Frazier from Truist Securities. Please go ahead. Hey, thanks. Good afternoon, folks.

Hey, Thanks, good afternoon folks I am not sure if I missed this but on.

Operator: I'm not sure if I missed this, but on Grace, did you comment on how many patients have been enrolled so far? No, I did not comment on the number of patients enrolled so far. You know, we don't typically comment on the number of patients that are totally enrolled, but I will give you some commentary on coming out of the pandemic. March was our best enrolled to date of this trial. Seeing good progress coming out of the pandemic.

Great did you comment on how many patients have been enrolled so far.

No I did not comment on the number of patients enrolled so far.

We don't typically comment on the number of patients that are totally enrolled but I will give you some commentary on them coming out of the pandemic March was our best enrolled to date of this trial. So we're seeing good progress coming out of the pandemic.

Operator: That's just not a metric we report. Unknown Speaker, SG&A's been stepped up in the quarter, were there any temporary drivers of the higher spend in Q1 or is that level sort of a new normal from which they'll grow?

That's just not a metric we report Greg.

Okay understood.

SG&A spend stepped up in the quarter or was there any temporary drivers at the higher spend in Q1 or is that level sort of a new normal for them, which still grow.

Alibaba.

Unknown Executive: Sure. Hey, Greg. That's, That's pretty, you know, as we talked about, we've expanded our teams and that's, that's a big driver of it. There are some temporary things like legal, For the most part, I think of that as our goal.

Hey, Greg.

Yes.

That's pretty.

We talked about we've expanded our teams and that's that's a big driver of it there are some temporary things like legal expenses, but for the most part I think of that as our portfolio.

Got it okay.

Joseph Belanoff: Got it. Okay. And then you have a number of academic collaborators that are conducting studies of cortisol modulators in different settings, like alcohol use disorder, epilepsy. Do you anticipate getting data from any of those studies this year? If you could just lay out what you might learn and when from those activities, that would be helpful.

And then you have a number of academic collaborators that are conducting studies that cortisol modulators in different settings like alcohol use disorder epilepsy do you anticipate getting data from many of those studies. This year. If you could just lay out what you might learn and learn from those activities that would be helpful. Thank you. Yes. This is really like a watershed day.

Joseph Belanoff: Thank you. Yeah, this is really like a watershed day. I love talking about this stuff. No one ever asks me about it, so you got me started. We have at any given point, including today, about 35 different academic collaborations, about half in the United States, half outside of the United States, about half preclinical, And now, to answer your question, yes, I do think that some of these studies...

I Love talking about this stuff no one ever asked me about itself.

Got me started.

We have at any given point, including today about 35 different academic collaborations.

Cortisol modulators that happen in the United States that have outside of the United States about half preclinical and clinical and Thats to answer your question.

Yes, I do think that some of these studies will produce results this year, but just remember they're not our studies they belong to the clinical investigators and the academic investigators who are doing them I can tell you just as a broad statement. Yes, you will see results from some of the studies this year I do know where they are.

Joseph Belanoff: Unknown Attendee, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Madock, William Guyer, Corcept Therapists Inc. Relo Coraline Study and Process. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William Guyer, Corcept Therapeutics Inc. Thanks for taking the questions. We have our next question from Arthur from HC Wainwright. Please go ahead. Hey, good afternoon, gentlemen. This is Arthur in for RK.

Particularly.

One, which would be preferring to which <unk> study in prostate cancer.

It will be relatively soon but there are others I am and you mentioned it very very interested in seeing the study results in the alcohol use disorder study, which is being done at Scripps.

So fingers crossed ominous as.

Is anxious to see those results as you are and there's a broad range of them so stay tuned.

Thanks for taking the questions.

We have our next question from Arthur.

H C. Wainwright. Please go ahead.

Hey, good afternoon gentlemen.

Third in for RK.

Unknown Executive: Most of my questions have been answered. I just want to follow up on the MASH study. Could you guys give us an update on the enrollment status for this study and how many of those levels have been tested so far, and when could we expect to initially clean the data from the study? Thank you. Well, thank you for that question.

Most of my question has been answered.

I just wanted to follow up on the match study could you guys give us an update on the enrollment status for this study and how many dose level has been passed so far.

And when could we expect the initial clinical data from this study. Thank you.

And the plan is to finish this trial and all of the cohorts this year.

Awesome. Thank you.

Thank you Arthur.

We have our next question from <unk>. Please go ahead and please state your company name.

Operator: Thank you. Thank you. We have our next question from Taizeen Hamad, please go ahead and please state your company name. Hey, this is Leon Wang on for Tazine.

Hey, this is Leon Wang on for <unk>, just a quick question.

Unknown Executive: Just a quick question. In terms of the some of the legal expenses that you mentioned as an OpEx driver in 1Q, can you get some more color on that? I mean, is this from IP or NDA? Or is there some other kind of legal expense that you are incurring?

In terms of.

Some of the legal expenses that you mentioned that Opex driver. Once you can you give some more color on that I mean is this.

From IP or Anda or is there some other kind of legal expense that you are incurring.

No it's nothing it's nothing new.

Unknown Executive: No, it's nothing. It's nothing new. You know, we're at the stage of you know, we're producing information for the DOJ, class action lawsuit happens to be kind of the same. Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, That's what you're seeing this quarter.

We're at the stage again, we're producing information from the Doj class action lawsuit happens to be kind of the same.

Calendar phase.

No.

Yeah.

Getting enough people charging by the hour in a room looking through documents and doing email queries and you can really rack up a bill and Thats whats going on here, but once.

That's sort of a bolus of expense that we just have to work through them.

Unknown Executive: Can't comment on future quarters that much because it's always a little bit unpredictable how these things go, but you're seeing that this quarter for sure. Okay, gotcha. So just for this quarter, you're expecting this, more bolus of a quarter versus maybe perhaps some future quarters coming up. Yeah, I mean, we will get through this set of expenses.

Okay Gotcha. So just for this quarter you are expecting this.

More bullish over quarter versus maybe perhaps some future quarters coming up.

Yes, I mean, we.

We will get through this set of expenses and Thats, all I can really say with any certainty.

Alright, thank you.

We have our next question from Alan <unk> from My Watch New Please go ahead.

Unknown Executive: And that's all I can really say about it with with any certainty. All right, thank you. We have our next question from Alan Yeung from Biowatchnew, please go ahead. Hey, thanks for taking my questions. And Joe, it's good to hear from you again. Yeah. Hi, Alan. I ask a couple of different questions. I wanted to bring back an OD.

Hey, Thanks for taking my question then Joe.

It's good to hear from you again.

Yes Alan.

I'll ask a couple of different questions I wanted to piggy back annuity.

Joseph Belanoff: I want to ask about the FKB-P5 mRNA expression test for GR receptor activity. You still like what you see and assuming all goes well, do you aim to market the test with a Reliquor lamp commercial launch? Yeah, thank you for that question, Alan, just to, I know how closely you follow, but just for the rest. One of the things that we're really very interested in working on is seeing if we can come up with a more accurate test for cortisol activity than exists at the current time.

You asked about the FTB peak.

Five mrna expression tests for GR receptor activity.

Still like what you see in assuming all goes well.

And to market the test with a relative <unk> commercial launch.

Yes.

For that question Alan.

I know how closely you follow that just for the rest of the listeners one of the things that we're really very interested in working on a scene you can come up with.

A more accurate test of cortisol activity and exist at the current time that there really are no tests for cortisol activity at this time only cortisol level as mentioned and again I just say this for the whole audience.

Joseph Belanoff: In fact, there really are no... Activity at this time. Only cortisol level is made. And Alan, I again, I just say this for the whole audience. I don't, I, you may be aware of it, but we have now published the results from, Surgical and Post-Surgical Study of FKBP5 in Patients with Cushing's Now, you know, Unknown Attendee, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Sean Maduck, William, And so we think it's very important.

I don't I.

You may be aware of it but we have now published the results from <unk>.

Surgical and post surgical study <unk> five.

In patients with Cushings disease now.

<unk> reviewed.

Strong journal.

But the most important thing to tell you is we collect that information <unk> changes and all the studies that we do.

And so we think it's very important we will see where that shakes out certainly an experiment but.

Joseph Belanoff: We'll see where that shakes out. Certainly an experiment, but it would be a terrific experiment because one of the things that any clinician will tell you is that patients can have severe Cushing syndrome with moderate levels of cortisol, and Moderate Cushing Syndrome with Extraordinarily High Levels, doesn't really match up so, Our hope is that this measure will match up more actively, very, very useful positions.

Our hope is that this measure will match up more accurately very useful to physicians will it be ready at the time that the rail coral an NDA submitted I doubt. It I think it is going to actually state that but.

Joseph Belanoff: Will it be ready at the time that the RELLA, Correlent, NDA is submitted? I doubt it. I think it's going to actually postdate that.

Joseph Belanoff: But, you know, if you want to cross your fingers and as soon as the results are good, I'm hoping it won't be too much behind that. So, you know, it's not going to be, if the question was, is it going to be part of what's needed for the NDA or RELLA, Correlent and Cushing Syndrome? It is not. It really is its own finding should it come to pass. How long did the phase last for Court 125-329?

If you want to cross fingers and assume that the results are good I'm, hoping it won't be too much behind that so it.

It's not going to be.

If the question was is it going to be part of what's needed for the NDA for <unk> in Cushing syndrome. It is not it really is it smooth finding should come to pass.

How does the phase one.

<unk> five three to nine.

Joseph Belanoff: Was it what you hoped, or is it just something that's put to rest for now? You know, Alan, again, appreciate your understanding of all the detail we're in. Hazel Hunt, who is our really fantastic medicinal chemist and came up with all of these compounds, you know, has several compounds, you know, both preclinical and inclinical. I can tell you 1, 2, 5, 3, 2, 9, just you can file it away somewhere, is a potent glucocorticoid receptor modulator, where we take it, uncertain at this point in time because, you know, as I commented on before, after we find out that it really is the modulator. We then begin other biological assays to see where it can be best placed.

What's you hoped or is it just something thats put the rest for now.

Our 10 year <unk>.

State your understanding of all the detail we are in.

Hunt, who is our really fantastic medicinal chemists and came up with all of these compounds.

Several compounds, both preclinical and clinical.

I can tell you once you've bought three to nine.

Violet away somewhere is a potent critical receptor modulator, where we take it uncertain at this point in time, because as I commented on before.

After we find out that it really is the modulator that we hope it to be.

We then began other biological assays to see where it can be best places at a pace.

Joseph Belanoff: Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Swayampakula Ramakanth, Joon Lee, Atabak Mokari, Thank you. Looking forward to your next quarter. Yeah, nice to talk to you again, Alan. I think this concludes all the people who had questions, so thank you very much for all the detail. We'll obviously release information as we have it, and we'll talk to you about three months from now. Ladies and Gentlemen, this concludes today's presentation. Thank you for participating. You may now disconnect.

Apologies invest in <unk>.

Metabolic diseases, and that's actually taking place right now.

Yes.

Thank you looking forward to next quarter.

Yes, nice to talk to you again Alan.

I think this concludes all the people who had questions. So thank you very much.

For a detailed will obviously release information as we have it and we'll talk to you about three months from now.

Yeah.

Ladies and gentlemen. This concludes today's presentation. Thank you for participating you may now disconnect.

Q1 2022 Corcept Therapeutics Inc Earnings Call

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