Q2 2024 Corcept Therapeutics Inc Earnings Call

Operator: Hello, thank you for standing by.

Operator: Hello, thank you for standing by. Welcome to Corcept 3rd Produce Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. So, ask the question. During this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.

Speaker Change: Hello, thank you for standing by. Welcome to Corcept Therapeutics conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session.

Operator: Welcome to the Corcept Therapeutics conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. I would now like to turn the call over to Atabak Mokari. You may begin.

Speaker Change: To ask a question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again.

Atabak Mokari: I will now like to turn the call over to Atabak Mokoro; you may begin.

Speaker Change: I would now like to turn the call over to Atabak Mokari. You may begin.

Atabak Mokari: Hello everyone, good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. The copy is available at Corcept.com. Our complete financial results will be available when we file our Form 10-Q with SEC. Today's call is being recorded. Every play will be available to investors' past events tab of our website.

Atabak Mokari: Hello, everyone. Good afternoon, and thank you for joining us.

Atabak Mokari: Hello everyone. Good afternoon and thank you for joining us. Today we issued a press release announcing our financial results for the second quarter and providing a corporate update.

Atabak Mokari: Today we issued a press release announcing our financial results for the second quarter and providing a corporate update. A copy is available at Corcept.com. Our complete financial results will be available when we file our Form 10-2 with the SEC. This call is being recorded.

Speaker Change: A copy is available at Corcept.com. Our complete financial results will be available when we file our Form 10-2 with the SEC.

Atabak Mokari: A replay will be available on 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 might cause actual results to be materially different from those such statements express or imply. 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.

Speaker Change: Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website.

Atabak Mokari: Statements during this call, other than statements of historical facts, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different 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-Q and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We display any intention or duty to update forward-looking statements.

Atabak Mokari: We disclaim any intention or duty to update forward-looking statements. Our revenue in the second quarter of 2024 was $163.8 million, an increase of 39% compared to the second quarter of the prior year. We expect our revenue growth to continue and have increased our 2024 revenue guidance to $640 to $670 million. Net income was $35.5 million in the second quarter compared to $27.5 million in the second quarter of the prior year. Our cash and investments at June 30th stood at $492.5 million. I will now turn the call over to Charlie Robb, our Chief Business Officer.

Speaker Change: Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different from those such statements express or imply.

Speaker Change: 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 .

Speaker Change: Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements.

Atabak Mokari: Our revenue in the second quarter of 2024 was $163.8 million, an increase of 39% compared to the second quarter of the prior year. We expect our revenue growth to continue and have increased our 2024 revenue guidance to $640 to $670 million. That income was $35.5 million in the second quarter compared to $27.5 million in the second quarter of the prior year. Our cash and investment at June 30th was $492.5 million.

Speaker Change: Our revenue in the second quarter of 2024 was $163.8 million, an increase of 39% compared to the second quarter of the prior year. We expect our revenue growth to continue and have increased our 2024 revenue guidance to $640 to $670 million.

Speaker Change: Net income was $35.5 million in the second quarter compared to $27.5 million in the second quarter of the prior year.

Atabak Mokari: I will now turn the call over to Charlie Robb, our Chief Business Officer.

Speaker Change: Our cash and investments at June 30th was $492.5 million.

Charlie Robb: Charlie? Thanks, Hadabak. I don't have much to report this quarter.

Gary Charles Robb: I will now turn the call over to Charlie Robb, our Chief Business Officer. Charlie? Thanks, Atabak. I don't have much to report this quarter.

Gary Charles Robb: I don't have much to report this quarter. As many of you know, in March 2018, we sued Teva to stop it from marketing a generic version of Coralim in violation of our patents. In December last year, the trial court ruled against us, and we appealed that decision to the Federal Circuit Court of Appeal. Briefing in the matter is complete. The documents are available on the government's PACER website, if anyone would like to review

Charlie Robb: As many of you know, in March 2018, we sued Teva to stop it from marketing a generic version of Correlament in violation of our patents. In December last year, the trial court ruled against us. We've appealed that decision to the Federal Circuit Court of Appeals. Briefing in the matter is complete. The documents are available at the government's pace or website. Anyone would like to review them. And the next step is for the Federal Circuit to schedule oral argument. The timing of oral argument and the issuance of an opinion are entirely up to the Federal Circuit and can't be known with certainty.

Gary Charles Robb: The next step is for the Federal Circuit to schedule oral arguments. Timing of oral argument and issuance of an opinion are entirely up to the Federal Circuit and can't be known with certainty. As I said before, a reasonable expectation would be for oral arguments to take place in the fourth quarter, perhaps late in the third quarter of this year, with a decision issuing in the first quarter of 2025, possibly very late in the fourth quarter of 2025.

Speaker Change: As many of you know, in March 2018, we sued Teva to stop it from marketing a generic version of Coralim in violation of our patents. In December last year, the trial court ruled against us. We've appealed that decision to the Federal Circuit Court of Appeals.

Speaker Change: Briefing in the matter is complete. The documents are available at the government's PACER website, if anyone would like to review them. And the next step is for the Federal Circuit to schedule oral argument. The timing of oral argument and issuance of an opinion are entirely up to the Federal Circuit and can't be known with certainty.

Charlie Robb: As I said before, a reasonable expectation would be for oral arguments to take place in the fourth quarter, perhaps late in the third quarter of this year, with the decision issuing in the first quarter of 2025, possibly very late in the fourth quarter of 2024. If we prevail, Teva would lose FDA approval if its product and after moving from the market, at least until the expiration of our patents in 2037. As I've said before, we're eager to advance this appeal. You strongly believe that our position is correct; the Federal Circuit, for its deep expertise in patent law, will agree.

Speaker Change: As I said before, a reasonable expectation would be for oral arguments to take place in the fourth quarter, perhaps late in the third quarter of this year, with a decision issuing in the first quarter of 2025, possibly very late in the fourth quarter of 2024.

Gary Charles Robb: If we prevail, Teva would lose FDA approval of its product and have to remove it from the market, at least until the expiration of our patents in 2037. As I've said before, we're eager to advance this appeal. Swayampakula Ramakanth, Atabak Mokari, Sean Maduck, William Guyer, Alan Leong, Corcept Therapeutics Inc. I'll now turn the call over to Joe Belanoff, our Chief Executive Officer. Thank you.

Speaker Change: If we prevail, Teva would lose FDA approval of its product and have to remove it from the market, at least until the expiration of our patents in 2037.

Speaker Change: As I've said before, we're eager to advance this appeal.

Speaker Change: We strongly believe that our position is correct, and the Federal Circuit, with its deep expertise in patent law, will agree.

Joe Belanoff: I'll now turn the call over to Joe Bellinoff, our Chief Executive Officer.

Joe Belanoff: Joe? Thank you, Charlie, and thank you everyone for joining us this afternoon. This has been an extremely active period at Corcept. Our commercial business continues to be very strong, and we are making progress in all of our clinical development programs. Our technology division was driven by another record number of new Coralem prescribers and by a record number of patients receiving Coralem. As physicians become increasingly aware that hypercorazalism is much more prevalent than previously assumed, they are screening and treating more patients. When Coralem is prescribed, we use the expertise and infrastructure that we have developed and refined over many years to support physicians and patients.

Joseph K. Belanoff: Thank you, Charlie. And thank you, everyone, for joining us this afternoon.

Speaker Change: I'll now turn the call over to Joe Belanoff, our Chief Executive Officer. Joe?

Joseph K. Belanoff: Thank you, Charlie. And thank you, everyone, for joining us this afternoon. This has been an extremely active period at Corcept. Our commercial business continues to be very strong, and we are making progress in all of our clinical development programs.

Joseph K. Belanoff: This has been an extremely active period at Corcept. Our commercial business continues to be very strong, and we are making progress in all of our clinical development programs. The past quarter marks several significant milestones for our endocrinology division. I will take a few minutes to elaborate on each area of progress. Individually, they are of great importance, and collectively even more so.

Speaker Change: The past quarter marks several significant milestones for our endocrinology division. I will take a few minutes to elaborate on each area of progress. Individually, they are of great importance and collectively even more so.

Joseph K. Belanoff: The commercial growth in our endocrinology division was driven by another record number of new quorum prescribers and by a record number of patients receiving quorum. As physicians become increasingly aware that hypercortisolism is much more prevalent than previously assumed, they are screening and treating more patients. On Coralim as Prescribed, we use the expertise and infrastructure that we have developed and refined over many years to support physicians and patients.

Speaker Change: The commercial growth in our endocrinology division was driven by another record number of new quorum prescribers and by a record number of patients receiving quorum.

Speaker Change: As physicians become increasingly aware that hypercortisolism is much more prevalent than previously assumed, they are screening and treating more patients.

Speaker Change: When Corallum is prescribed, we use the expertise and infrastructure that we have developed and refined over many years to support physicians and patients.

Joe Belanoff: We have known for some time that there were more patients who would benefit from screening for Cushing syndrome and ultimately from treatment and was commonly recognized. The findings from the prevalence portion of the Catalyst study make it clear that there are many more patients with hypercorazalism than was previously recognized. Catalyst is the largest and most rigorous clinical study ever conducted to examine the prevalence of hypercorazalism in patients with difficulty control type 2 diabetes. Of the first 1555 patients enrolled in the Catalyst study, one in four were found to have hypercorazalism. This is a far higher prevalence rate than was assumed, with large implications for patient care.

Joseph K. Belanoff: We have known for some time that there are more patients who would benefit from screening for Cushing syndrome and ultimately from treatment than was commonly recognized. The findings from the prevalence portion of the Catalyst Study make it clear that there are many more patients with hypercorazolism than was previously recognized. Catalyst is the largest and most rigorous clinical study ever conducted to examine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. Of the first 1,055 patients enrolled in the Catalyst study, one in four were found to have hypercortisolism. This is a far higher prevalence rate than was assumed, with major implications for patient care.

Speaker Change: We have known for some time that there were more patients who would benefit from screening for Cushing syndrome, and ultimately from treatment, than was commonly recognized. The findings from the prevalence portion of the CATALYST study make it clear that there are many more patients with hypercorazolism than was previously recognized.

Speaker Change: Catalyst is the largest and most rigorous clinical study ever conducted to examine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes.

Speaker Change: Of the first 1,055 patients enrolled in the Catalyst Study, one in four were found to have hypercortisolism. This is a far higher prevalence rate than was assumed, with large implications for patient care.

Joseph K. Belanoff: Hypercortisolism was even more common in patients in this study with already recognized cardiovascular disease, particularly in those who needed three or more medications to manage their hypertension. In fact, more than a third of this group of patients had hypercortisolism. The Catalyst study was led by the top diabetologist in the United States, and the results from the prevalence portion of the study were presented at the American Diabetes Association's annual scientific sessions in Orlando last month. Much has subsequently been written about this presentation.

Joe Belanoff: Hypercorazalism was even more common in patients in this study with already recognized cardiovascular disease, particularly in those who need three or more medications to manage their hypertension. More than a third of this group of patients had hypercorazalism. The Catalyst study was led by the top diabetologist in the United States, and the results from the prevalence portion of the study were presented at the American Diabetes Association's annual scientific sessions in Orlando last month. Much has subsequently been written about this presentation. The second portion of the Catalyst study is ongoing. In this part of the study, patients are randomized to receive either a choralum or placebo.

Speaker Change: Hypercortisolism was even more common in patients in this study with already recognized cardiovascular disease, particularly in those who needed three or more medications to manage their hypertension. More than a third of this group of patients had hypercortisolism.

Speaker Change: The Catalyst Study was led by the top diabetologist in the United States, and the results from the prevalence portion of the study were presented at the American Diabetes Association's Annual Scientific Sessions in Orlando last month. Much has subsequently been written about this presentation.

Joseph K. Belanoff: The second portion of the Catalyst Study is ongoing. In this part of the study, patients are randomized to receive either Corallum or placebo. Study results will be available at the end of this year. Meanwhile, as the awareness of Cushing syndrome increases, we are simultaneously working to advance our proprietary Selective Cortisol Modulator, Relacoralin. Reliquorollant has unique characteristics, and our confidence in its efficacy and safety profile has increased with the results of the GRACE study. As you recall, GRACE has two parts.

Speaker Change: The second portion of the Catalyst Study is ongoing. In this part of the study, patients are randomized to receive either a corallum or placebo. The study results will be available at the end of this year.

Joe Belanoff: The study results will be available at the end of this year.

Joe Belanoff: As the awareness of Cushing syndrome increases, we are simultaneously working to advance our proprietary selective cortisol modulator, Relicoralant. Relicoralant has unique characteristics, and our confidence in its efficacy and safety profile has increased with the results of the great study. As you recall, race has two parts. In the open label phase, 152 patients with Cushing syndrome and either hypertension, hyperglycemia, or bold, received Relicoralant for 22 weeks. Patients who met pre-specified improvements were given the opportunity to enter the trials, randomized, double-blind, with a worked-or-all phase, in which half of the patients continued to receive Relicoralant and half received 3-0 for 12 weeks.

Speaker Change: As the awareness of Cushing Syndrome increases, we are simultaneously working to advance our proprietary selective cortisol modulator, Relacorrelant.

Speaker Change: Relic Orland has unique characteristics and our confidence in its efficacy and safety profile has increased with the results of the GRACE study.

Joseph K. Belanoff: In the open-label phase, 152 patients with Cushing syndrome and either hypertension, hyperglycemia, or both received breloquoralin for 22 weeks. Patients who met pre-specified improvements were given the opportunity to enter the trial's randomized double blind withdrawal phase, in which half of the patients continue to receive reluquorulent and half receive EVO for 12 months. Patients in the open-label phase of GRACE exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing's quality of life score, and other measures of clinical importance.

Speaker Change: As you recall, GRACE has two parts. In the open label phase, 152 patients with Cushing syndrome and either hypertension, hyperglycemia, or both received varelocloralin for 22 weeks.

Joseph K. Belanoff: 63% of the patients with hypertension met the study's response criteria. Patients who enter the randomized withdrawal phase of GRACE experience mean systolic and diastolic blood pressure improvements of 12.6 and 8.3 millimeters of mercury as measured by 24 hour ambulatory blood pressure monitoring. The p value for their change from baseline was less than 0.0001. Additionally, 50% of the patients with hyperglycemia met the study's response criteria. The hyperglycemic group consisted of patients with diabetes and those with impaired glucose tolerance or prediabetes.

Speaker Change: Patients who met pre-specified improvements were given the opportunity to enter the trial's randomized double-blind withdrawal phase, in which half of the patients continued to receive Rella-Correlant and half received Devo for 12 weeks.

Joe Belanoff: Patients in the open label phase of race exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, cushions quality of life score, and other measures clinical import. 63% of the patients with hypertension met the study's response criteria. Patients who enter the randomized withdrawal phase of grace experience mean systolic and diastolic blood pressure improvements of 12.6 and 8.3 millimeters of mercury as measured by 24-hour ambulatory blood pressure monitoring. The p-value on their change from baseline was less than 0.001. 50% of the patients with hyperglycemia met the study's response criteria.

Speaker Change: Patients in the open-label phase of GRACE exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing's quality of life score, and other measures of clinical importance.

Speaker Change: 63% of the patients with hypertension met the study's response criteria.

Speaker Change: Patients who enter the randomized withdrawal phase of GRACE experience mean systolic and diastolic blood pressure improvements of 12.6 and 8.3 millimeters of mercury as measured by 24-hour ambulatory blood pressure monitoring.

Speaker Change: The p-value on their change from baseline was less than .0001.

Joe Belanoff: The hyperglycemic group consists of patients with diabetes and those with impaired glucose tolerance or pre-diabetes. For the patients who enter the randomized withdrawal phase, a reduction in mean hemoglobin A1c, a 0.7% p-value less than 0.001, and a reduction in mean fasting glucose of 25.2 milligrams per deciliter, p-value of 0.006 was achieved. In the randomized withdrawal phase, which compared patients taking relicorlant to those taking placebo, GRACE met its primary endpoint of maintenance of blood pressure control. The odds ratio, which is the primary endpoint in the statistical analysis plan in place with the FDA, was 0.17 with a p-value of 0.02.

Speaker Change: Fifty percent of the patients with hyperglycemia met the study's response criteria. The hyperglycemic group consisted of patients with diabetes and those with impaired glucose tolerance or prediabetes.

Joseph K. Belanoff: For the patients who entered the randomized withdrawal phase, a reduction in mean hemoglobin A1c of 0.7%, p-value less than 0.0001, and a reduction in mean fasting glucose of 25.2 milligrams per deciliter, p-value of 0.006 were achieved. In the randomized withdrawal phase, which compared patients taking Relacorlin to those taking placebo, GRACE met its primary endpoint of maintenance of blood pressure The odds ratio, which is the primary endpoint in the statistical analysis plan in place with the FDA, was 0.17, with a p-value of 0.02.

Speaker Change: For the patients who entered the randomized withdrawal phase, a reduction in mean hemoglobin A1c, a 0.7 percent, p-value less than 0.0001, and a reduction in mean fasting glucose of 25.2 milligrams per deciliter, p-value of 0.006, was achieved.

Speaker Change: In the randomized withdrawal phase, which compared patients taking relacorlin to those taking placebo, GRACE met its primary endpoint of maintenance of blood pressure control.

Speaker Change: The odds ratio, which is the primary endpoint in the statistical analysis plan in place with the FDA, was 0.17 with a p-value of 0.02.

Joe Belanoff: Patients taking relicorlant were six times more likely to maintain their blood pressure response compared to those taking placebo. In addition, patients who continue to take relicorlant in the randomized withdrawal phase maintain the broad range of improvements observed in the open label phase, while those who receive placebo experienced a significant worsening of their symptoms. In both phases of grace, relicorlant was well tolerated, consistent with its known safety profile. Due to its unique mechanism of action, there were no relicorlant-induced instances of hypokalemia. In addition, there were no cases of drug-induced endometrial hypertrophy, no cases of adrenal insufficiency, and no cases of QT interval prolongation, which was independently confirmed.

Joseph K. Belanoff: Patients taking relaquorrelant were six times more likely to maintain their blood pressure response compared to those taking placebo. In addition, patients who continue to take relucorolant in the randomized withdrawal phase maintained the broad range of improvements observed in the open label phase, while those who received placebo experienced a significant worsening of their symptoms. In both phases of GRACE, Relaquarelant was well tolerated, consistent with its known safety profile. Due to its unique mechanism of action, there were no Relaquarelant-induced instances of hypokalemia.

Speaker Change: Patients taking relaquorrelant were six times more likely to maintain their blood pressure response compared to those taking placebo.

Speaker Change: In addition, patients who continue to take relocorrelant in the randomized withdrawal phase maintain the broad range of improvements observed in the open-label phase, while those who receive placebo experience a significant worsening of their symptoms.

Speaker Change: In both phases of GRACE, roloquorrelent was well-tolerated, consistent with its known safety profile.

Joseph K. Belanoff: In addition, there were no cases of drug-induced endometrial hypertrophy, no cases of adrenal insufficiency, and no cases of QT prolongation, which was independently confirmed. In June, we presented results from GRACE at the Endocrine Society Annual Meeting in Boston and the Heart and Diabetes Conference in Philadelphia. Grace's clearly positive results are a welcome development for patients with Cushing syndrome and constitute a significant step forward toward our new drug application for relacorrelant, which we plan to submit in the fourth quarter.

Speaker Change: Due to its unique mechanism of action, there were no reliquorrelent-induced instances of hypokalemia. In addition, there were no cases of drug-induced endometrial hypertrophy, no cases of adrenal insufficiency, and no cases of QT prolongation, which was independently confirmed.

Joe Belanoff: In June, we presented results from grace at the Endocrine Society Annual Meeting in Boston and the Heart and Diabetes Conference in Philadelphia. Grace's clearly positive results are a welcome development for patients with Cushing syndrome and constitute a significant step forward towards our new drug application for relicorlant, which we plan to submit in the fourth quarter.

Speaker Change: In June , we presented results from GRACE at the Endocrine Society Annual Meeting in Boston and the Heart and Diabetes Conference in Philadelphia.

Speaker Change: Grace's clearly positive results are a welcome development for patients with Cushing syndrome and constitute a significant step forward towards our new drug application for Rellocorrelant, which we plan to submit in the fourth quarter.

Joe Belanoff: Grace is not our only Phase 3 trial of relicorlant in patients with hypercortisolism. Gradient is a randomized double-blind placebo-controlled study in 137 patients whose hypercortisolism is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of cushion syndrome often experience a less rapid decline, but their health outcomes rapport include a significantly higher risk of premature death. We expect Radiant to produce valuable data about the treatment of an etiology of cushion syndrome that affects many patients. Enrollment is complete, and we expect data in the fourth quarter of this year.

Joseph K. Belanoff: Grace is not our only phase three trial of relachloralant in patients with hypercortisolism. Gradient is a randomized, double-blind, placebo-controlled study in 137 patients whose hypercortisolism is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but their health outcomes are poor and include a significantly higher risk of premature death. We expect RADIAN to produce valuable data about the treatment of an etiology of Cushing's syndrome that affects many patients. Enrollment is complete, and we expect data in the fourth quarter of this year.

Speaker Change: Grace is not our only Phase III trial of Rella Chloralent in patients with hypercortisolism.

Speaker Change: Gradient is a randomized, double-blind, placebo-controlled study in 137 patients whose hypercortisolism is caused by an adrenal adenoma or adrenal hyperplasia.

Speaker Change: Patients with this etiology of Cushing syndrome often experience a less rapid decline, but their health outcomes are poor and include a significantly higher risk of premature death.

Speaker Change: We expect RADIANT to produce valuable data about the treatment of an etiology of Cushing syndrome that affects many patients. Enrollment is complete and we expect data in the fourth quarter of this year.

Joe Belanoff: As you know, we are also studying Relicorlant as a treatment for different types of cancer mediated by cortisol activity. Our most advanced oncology program is in platinum-resistant ovarian cancer. We completed an enrollment of 381 women in our Pivotal Rosella study and expect to have enough events to analyze the primary endpoint of the study, progression-free survival by year end. Blue and white platinum resistant ovarian cancer are an urgent need of new treatment options. The goal of using relicoralint in this context is to resensitize ovarian tumors to the effects of chemotherapy by blunting the anti-apoptotic effect of the patient's excessive cortisol activity.

Joseph K. Belanoff: As you know, we are also studying relucorolant as a treatment for different types of cancer mediated by cortisol activity. Our most advanced oncology program is in platinum-resistant ovarian cancer. We completed enrollment of 381 women in our Pivotal Rosella study and expect to have enough events to analyze the primary endpoint of the study, progression-free survival, by year-end. Women with platinum-resistant ovarian cancer are in urgent need of new treatment options.

Speaker Change: As you know, we are also studying relucorolant as a treatment for different types of cancer mediated by cortisol activity.

Speaker Change: Our most advanced oncology program is in platinum-resistant ovarian cancer.

Speaker Change: We completed enrollment of 381 women in our Pivotal Rosella Study and expect to have enough events to analyze the primary endpoint of the study, progression-free survival, by year-end.

Joseph K. Belanoff: The goal of using relucorolant in this context is to resensitize ovarian tumors to the effects of chemotherapy by blunting the anti-apoptotic effect of the patient's excessive cortisol activity. Our goal for Rosella is to replicate our successful 178 patient-controlled phase two trial, which showed that women who received Reliquorrelent Intermittent, the day before, the day of, and the day after they received napaclitaxel exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received napaclitaxel monotherapy.

Speaker Change: Women with platinum-resistant ovarian cancer are in urgent need of new treatment options. The goal of using Relucorolant in this context is to resensitize ovarian tumors to the effects of chemotherapy by blunting the anti-apoptotic effect of the patient's excessive cortisol activity.

Joe Belanoff: Our goal for Rosella is to replicate our successful 178 patient controlled phase 2 trial, which are the women who received relicoralint intermittently, the day before, the day of, and the day after they received napakula taxil, exhibited a statistically significant improvement in progression free survival and duration of response compared to the group who received napakula taxil monotherapy. Women in the relicoralint group also live longer than those in the comparator arm. 29% of the patients who took intermittent relicoralint were alive two years after study start versus only 14% who took napakula taxil alone. Importantly, the women who received relicoralint plus napakula taxil experienced no additional side effect burden compared to those who received napakula taxil alone.

Speaker Change: Our goal for Rosella is to replicate our successful 178 patient controlled phase 2 trial which showed that women who received Reliquorulent intermittently

Speaker Change: The day before, the day of, and the day after they received NAPACLITAXEL exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received NAPACLITAXEL monotherapy.

Joseph K. Belanoff: Women in the Relochloralant group also lived longer than those in the comparator arm. 29% of the patients who took intermittent Relochloralant were alive two years after study start versus only 14% who took napaclitaxel alone. Importantly, the women who received Relic Oralint plus Napaq Litaxil experienced no additional side effect burden compared to those who received Napaq Litaxil alone.

Speaker Change: Women in the Relachloralant group also lived longer than those in the comparator arm. 29% of the patients who took intermittent Relachloralant were alive two years after study start, versus only 14% who took napaclitaxel alone.

Speaker Change: Importantly, the women who received Reliquoriland plus Napaqlitaxel experienced no additional side effect burden compared to those who received Napaqlitaxel alone.

Joe Belanoff: The results from the study were published in the Journal of Clinical Oncology in June 2023, within an accompanying editorial, and presented at multiple US and European medical conferences. The design of Rosella closely tracks our previous Phase 2 trial. Women are randomized to one to one to receive either relicoralint plus napakula taxil or napakula taxil alone. The primary endpoint of Rosella is progression-free survival, with overall survival a key secondary endpoint. We are conducting the study in collaboration with leading clinicians from the Gynecological Oncology Group or GOG in the United States and the European Network of Gynecological Oncology Trials or INGOT grouped in Europe and deeply appreciate their enthusiasm and support.

Joseph K. Belanoff: Results from the study were published in the Journal of Clinical Oncology in June 2023 with an accompanying editorial and presented at multiple U.S. and European medical conferences. The design of Rosella closely tracks our previous phase two trial. Women are randomized to one-to-one to receive either Relacoralin plus Napaclitaxel or Napaclitaxel alone.

Speaker Change: Results from the study were published in the Journal of Clinical Oncology in June 2023 with an accompanying editorial and presented at multiple U.S. and European medical conferences.

Speaker Change: The design of Rosella closely tracks our previous Phase II trial. Women were randomized one-to-one to receive either Relacoralin plus Napaclitaxel or Napaclitaxel alone. The primary endpoint of Rosella is progression-free survival, with overall survival a key secondary endpoint.

Joseph K. Belanoff: The primary endpoint of Rosella is progression-free survival, with overall survival a key secondary endpoint. We are conducting the study in collaboration with leading clinicians from the Gynecological Oncology Group, or GOG, in the United States and the European Network of Gynecological Oncology Trials, or NGOT, group in Europe, and deeply appreciate their enthusiasm and support. In anticipation of a successful outcome, Roberto Vieira has joined us as President of our Oncology Division, and we have begun to make a number of other critical hires to ensure that we can move as quickly as possible following the conclusion of Rosella to bring Relochlorone to the women who can benefit from it.

Speaker Change: We are conducting the study in collaboration with leading clinicians from the Gynecological Oncology Group or GOG in the United States and the European Network of Gynecological Oncology Trials or NGOT group in Europe and deeply appreciate their enthusiasm and support.

Joe Belanoff: In anticipation of a successful outcome, Roberto Villera has joined us as president of our oncology division, and we've begun to make a number of other critical hires to ensure that we can move as quickly as possible following the conclusion of Rosella to bring relicoralint to the women who can benefit from it.

Roberto Vieira: In anticipation of a successful outcome, Roberto Vieira has joined us as President of our Oncology Division and we have begun to make a number of other critical hires to ensure that we can move as quickly as possible following the conclusion of Rosella to bring Relochlorone to the women who can benefit from it.

Joe Belanoff: We are also evaluating relicoralint as a treatment for prostate cancer and adrenal cancer by exploring two different mechanisms of action. Leading academic researchers and clinicians hypothesized that cortisol modulation may block an important tumor growth pathway in prostate cancer. Cortisol stimulation is thought to be a major reason why patients with prostate cancer treated with a widely prescribed antigen receptor antagonist and Zalutamide eventually experience resurgent disease. Deprived of antigen stimulation, their tumors switched to cortisol activity to stimulate growth. Adding a cortisol modulator to antigen deporation therapy could close this tumor escape route. Our collaborators at the University of Chicago are currently enrolling a randomized placebo-controlled phase 2 trial of relicoralint plus zalutamide in patients with prostate cancer.

Joseph K. Belanoff: We are also evaluating relaquorrelant as a treatment for prostate cancer and adrenal cancer by exploring two different mechanisms of action. Leading academic researchers and clinicians hypothesize that cortisol modulation may block an important tumor growth pathway in prostate cancer. Cortisol stimulation is thought to be a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist, enzalutamide, eventually experience resurgent disease. Deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth.

Roberto Vieira: We are also evaluating relacoralant as a treatment for prostate cancer and adrenal cancer by exploring two different mechanisms of action. Leading academic researchers and clinicians hypothesize that cortisol modulation may block an important tumor growth pathway in prostate cancer.

Roberto Vieira: Cortisol stimulation is thought to be a major reason why patients with prostate cancer treated with a widely prescribed androgen receptor antagonist, enzalutamide, eventually experience resurgent disease.

Roberto Vieira: Deprived of androgen stimulation, their tumors switched to cortisol activity to stimulate growth.

Joseph K. Belanoff: Adding a cortisol modulator to androgen deprivation therapy could close this tumor escape. Our collaborators at the University of Chicago are currently enrolling a randomized placebo-controlled phase 2 trial of brolocoralline plus enzalutamide in patients with prostate cancer before these patients have had an initial prostatectomy. In adrenal cancer, patients' tumors produce excess cortisol in about 50% of cases. Unfortunately, patients with this form of adrenal cancer virtually never respond to immunotherapy. Sadly, adrenal cancer usually progresses rapidly and is almost always a deadly disease.

Roberto Vieira: Adding a cortisol modulator to androgen deprivation therapy could close this tumor escape route.

Speaker Change: Our collaborators at the University of Chicago are currently enrolling a randomized placebo-controlled phase 2 trial of brolylchloroen plus Enzalutamide in patients with prostate cancer before these patients have had an initial prostatectomy.

Joe Belanoff: Before these patients have had an initial prostatectomy. In adrenal cancer, patients' tumors produce excess cortisol in about 50% of cases. Unfortunately, patients with this form of adrenal cancer virtually never respond to immunotherapy. Sadly, adrenal cancer usually progresses rapidly and is almost always a deadly disease. The COAS cortisol suppresses the immune system and may blunt the effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies, such as checkpoint inhibitors, may enhance their effectiveness. We use the improvement in these patients' cushion syndrome and the quality of life.

Speaker Change: In adrenal cancer, patients' tumors produce excess cortisol in about 50% of cases.

Speaker Change: Unfortunately, patients with this form of adrenal cancer virtually never respond to immunotherapy.

Speaker Change: Sadly, adrenal cancer usually progresses rapidly and is almost always a deadly disease.

Joseph K. Belanoff: Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies such as checkpoint inhibitors may enhance their effectiveness. We enrolled 14 patients with advanced adrenal cancer with tumors that produce excess cortisol in a phase 1B trial of relacorrelant plus the PD-1 checkpoint inhibitor pembrolizumab. As hoped for, treatment with relacorrelant produced an improvement in these patients' Cushing syndrome and their quality of life. However, it did not result in an observed change in tumor progression in this end-stage group.

Speaker Change: Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate the immune system.

Speaker Change: Our hypothesis is that adding a cortisol modulator to immunotherapies, such as checkpoint inhibitors, may enhance their effectiveness.

Speaker Change: We enrolled 14 patients with advanced adrenal cancer with tumors that produce excess cortisol in a Phase 1b trial of Brella Correlant plus the PD-1 checkpoint inhibitor Pembrolizumab.

Speaker Change: As hoped for, treatment with Relachloralan produced an improvement in these patients' Cushing syndrome and their quality of life. However, it did not result in an observed change in tumor progression in this end-stage group.

Joe Belanoff: However, it did not result in an observed change in tumor progression in this end-stage group.

Joe Belanoff: We are evaluating next steps to further understand the role of cortisol modulation in combination with immunotherapies and this and other types of cancer. Our research team has developed a library of more than 1,000 selective cortisol modulators with distinct pharmacodynamic properties. Some are more potent at modulating cortisol activity across many tissue types; some are tissue specific; some are very potent in oncologic models, some less so; some get into the brain, some don't. One of the compounds discovered by our scientists that is highly effective at getting into the brain is Dazook Orland. We have advanced Dazook Orland into clinical studies based on compelling data that showed improved motor performance and reduced neural inflammation and muscular atrophy in a commonly used mouse model of ALS.

Joseph K. Belanoff: We are evaluating next steps to further understand the role of cortisol modulation in combination with immunotherapies and this and other types of camps. Our research team has developed a library of more than 1,000 selective cortisol modulators with distinct pharmacodynamic properties. Some are more potent at modulating cortisol activity across many tissue types, while some are tissue specific. Some are very potent in oncologic models, some less so. Some get into the brain, some don't.

Speaker Change: We are evaluating next steps to further understand the role of cortisol modulation in combination with immunotherapies and this and other types of cancer.

Speaker Change: Our research team has developed a library of more than 1,000 selective cortisol modulators with distinct pharmacodynamic properties.

Speaker Change: Some are more potent at modulating cortisol activity across many tissue types, some are tissue specific. Some are very potent in oncologic models, some less so. Some get into the brain, some don't.

Joseph K. Belanoff: One of the compounds discovered by our scientists that is highly effective at getting into the brain is Daziquirulent. We've advanced Daziquirulent into clinical studies based on compelling data that showed improved motor performance and reduced neural inflammation and muscular atrophy in a commonly used mouse model of ALS. A randomized, double-blind, placebo-controlled Phase 2 DASLs trial, a DASA correlant, is fully enrolled and ongoing at clinical sites in Europe, the United States, and Canada. 249 patients with ALS have been randomized to receive Daziquirulent or placebo for 24 weeks. The primary endpoint utilizes the ALS Functional Rating Scale, and we expect data by year end.

Speaker Change: One of the compounds discovered by our scientists that is highly effective at getting into the brain is Dazuforlet.

Speaker Change: We've advanced DASIC Correlant into clinical studies based on compelling data that showed improved motor performance and reduced neural inflammation and muscular atrophy in a commonly used mouse model of ALS.

Joe Belanoff: Our randomized double-blind placebo control phase two Dazzles trial of Dazook Orland is fully enrolled in ongoing clinical sites in Europe, the United States, and Canada. 249 patients with ALS have been randomized to receive Dazook Orland or placebo for 24 weeks. The primary endpoint utilizes the ALS Functional Rating Scale. We expect data by year end.

Speaker Change: A randomized, double-blind, placebo-controlled Phase 2 DASLs trial of DASA-correlant is fully enrolled and ongoing at clinical sites in Europe , the United States, and Canada.

Speaker Change: 249 patients with ALS have been randomized to receive dazacorrelant or placebo for 24 weeks. The primary endpoint utilizes the ALS functional rating scale. We expect data by year-end.

Joe Belanoff: Finally, I'll turn to our program in MASH, which stands for Metabolic Dysfunction Associated Steato Hepatitis. MASH is a serious liver disease that affects millions of patients in the United States. Cortisol modulation may serve as an effective treatment for MASH because cortisol activity has been inculcated in both the initial development and progression of this disease. Our phase 1B Dose Finding Study of Miracoralland found that patients who received 100 milligrams orally twice a week for 12 weeks experience a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis, and key metabolic and lipid measures, such as Homa IAR, serum triglycerides, and LDL.

Joseph K. Belanoff: Finally, I'll turn to our program in MASH, which stands for Metabolic Dysfunction Associated Steatohepatitis. MASH is a serious liver disease that affects millions of patients in the United States. Cortisol modulation may serve as an effective treatment for MASH because cortisol activity has been implicated in both the initial development and progression of this disease. Our phase 1b dose finding study of miracorrelant found that patients who received 100 milligrams orally twice a week for 12 weeks experienced a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis, and key metabolic and lipid measures such as Importantly, mirror-correlant was also very well tolerated with no apparent GI side effects.

Speaker Change: Finally, I'll turn to our program in MASH, which stands for Metabolic Dysfunction Associated Steatohepatitis.

Speaker Change: MASH is a serious liver disease that affects millions of patients in the United States.

Speaker Change: Cortisol modulation may serve as an effective treatment for MASH because cortisol activity has been implicated in both the initial development and progression of this disease.

Speaker Change: Our phase 1b dose finding study of miracorrelant found that patients who received 100 milligrams orally twice a week for 12 weeks

Speaker Change: Experienced a 30% reduction in liver fat and improvements in liver enzymes, markers of fibrosis, and key metabolic and lipid measures such as HOMA-IR, serum triglycerides, and LDL.

Joe Belanoff: Importantly, Miracoralland was also very well tolerated, with no apparent GI side effects. We hope to expand on these encouraging results with our randomized double-blind placebo-controlled phase 2B Monarch Study. We are enrolling two cohorts in this study. The first cohort has a planned enrollment of 120 patients with biopsy confirmed MASH, randomized 2 to 1 to receive either 100 milligrams of Miracoralland twice weekly or placebo for 48 weeks. The primary endpoint for this cohort of the Monarch Study is reduction in liver fat, with MASH resolution and fibrosis improvement as key secondary endpoints. The second cohort has a planned enrollment of 75 patients with presumed MASH based on non-invested diagnostic tests.

Speaker Change: Importantly, mirror-correlant was also very well tolerated with no apparent GI side effects.

Joseph K. Belanoff: We hope to expand on these encouraging results with our randomized double-blind placebo-controlled Phase 2b MONARCH study. We are enrolling two cohorts in this study. The first cohort has a planned enrollment of 120 patients with biopsy-confirmed MASH, randomized two to one to receive either 100 milligrams of miracoralline twice weekly or placebo for 48 weeks. The primary endpoint for this cohort of the Monarch Study is reduction of liver fat with mass resolution and fibrosis improvement as key secondary endpoints.

Speaker Change: We hope to expand on these encouraging results with our randomized, double-blind, placebo-controlled Phase 2b Monarch Study.

Joseph K. Belanoff: The second cohort has a planned enrollment of 75 patients with presumed match based on non-invasive diagnostic tests. Patients in this cohort will be randomized two to one to receive either 100 milligrams of Miracorlin twice weekly for six weeks, followed by 200 milligrams of Miracorlin twice weekly for 18 weeks or placebo for 24 weeks. In this cohort, the primary endpoint is also reduction in liver fat.

Speaker Change: We are enrolling two cohorts in this study. The first cohort has a planned enrollment of 120 patients with biopsy-confirmed MASH, randomized 2-to-1 to receive either 100 mg of miracoralline twice weekly or placebo for 48 weeks.

Speaker Change: The primary endpoint for this cohort of the Monarch Study is reduction in liver fat with mass resolution and fibrosis improvement as key secondary endpoints.

Speaker Change: The second cohort has a planned enrollment of 75 patients with presumed match based on non-investive diagnostic tests.

Joe Belanoff: Patients in this cohort will be randomized two to one to receive either a hundred milligrams miracle or a miracle, and twice a liquid for six weeks, followed by two hundred milligrams of miracle, and twice a liquid for eighteen weeks, or placebo for twenty-four weeks. In this cohort, the primary endpoint is also a reduction in liver fat.

Speaker Change: Patients in this cohort will be randomized two-to-one to receive either 100 milligrams of miracorlin twice weekly for six weeks, followed by 200 milligrams of miracorlin twice weekly for 18 weeks, or placebo for 24 weeks.

Joe Belanoff: This is an extremely exciting time at Corcept. We are rapidly approaching transformational milestones for the company and, more important for patients in need. Our commercial business is strong and growing. The prevalence results from our catalyst trial make it clear that there are far more patients with Cushing syndrome than was previously assumed. The Grace Trial Demet results demonstrate that we developed a clearly superior treatment for patients with Cushing syndrome. By the end of this year, we expect data from our gradient and catalyst studies in Cushing syndrome, our pivotal Rosella study and ovarian cancer, and our Dazzle study in ALS.

Joseph K. Belanoff: This is an extremely exciting time at Corcept. We are rapidly approaching transformational milestones for the company and, more importantly, for patients in need. Our commercial business is strong and growing.

Speaker Change: In this cohort, the primary endpoint is also reduction in liver fat.

Speaker Change: This is an extremely exciting time at Corset. We are rapidly approaching transformational milestones for the company and, more important, for patients in need.

Joseph K. Belanoff: The prevalence results from our Catalyst trial make it clear that there are far more patients with Cushing syndrome than was previously assumed. The GRACE trial results demonstrate that we've developed a clearly superior treatment for patients with Cushing's syndrome. By the end of this year, we expect data from our gradient and catalyst studies in Cushing's syndrome, our pivotal Rosella study in ovarian cancer, and our DASL study in ALS. Every employee at Corcept and the partners and collaborators with whom we work understands the significance of the work we do.

Speaker Change: Our commercial business is strong and growing. The prevalence results from our Catalyst trial make it clear that there are far more patients with Cushing syndrome than was previously assumed.

Speaker Change: The GRACE trial results demonstrate that we've developed a clearly superior treatment for patients with Cushing's syndrome. By the end of this year, we expect data from our gradient and catalyst studies in Cushing's syndrome, our pivotal Rosella study in ovarian cancer, and our DASL study in ALS.

Joe Belanoff: Every employee at Corcept and the partners and collaborators with whom we work understands the significance of the work we do. Collectively, we are driven and guided by a sense of urgency to support patients with Cushing syndrome and all of the other disorders where cortisol modulation can make a difference.

Speaker Change: Every employee at Corcept and the partners and collaborators with whom we work understands the significance of the work we do.

Joseph K. Belanoff: Collectively, we are driven and guided by a sense of urgency to support patients with Cushing syndrome and all of the other disorders where cortisol modulation can make a difference. Operator, let's proceed now to questions. Thank you.

Speaker Change: Collectively, we are driven and guided by a sense of urgency to support patients with Cushing syndrome and all of the other disorders where cortisol modulation can make a difference.

Operator: Operator, let's proceed now to questions. Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 1-1 on your telephone and then wait to hear your name announced.

Operator: Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 1-1 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Matt Kaplan with Lattinburg. Your line is open.

Speaker Change: Operator, let's proceed now to questions.

Speaker Change: Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 1-1 on your telephone and then wait to hear your name announced.

Operator: To withdraw your question, please press start 1-1 again. Please stand by while we compile the Q&A roster.

Speaker Change: To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster.

Matthew Kaplan: Our first question comes from the line of Matt Katner with Latin Bird. Your line is open. Hey guys, thanks for taking the questions and congrats on the strong, coily results.

Speaker Change: Our first question comes from the line of Matt Kaplan with Lattenberg. Your line is open.

Matthew Lee Kaplan: Hey guys, thanks for taking the questions and congrats on the strong quarterly results. Joe, you mentioned in your prepared remarks that screening you've seen an increase in screening treatment in terms of the use of Coraline. I guess, where are we in terms of the awareness of the prevalence of hypercortisolism in the endo community now and in terms of the increase in screening?

Matthew Lee Kaplan: Hey guys, thanks for taking the questions and congrats on the strong quarterly results.

Matthew Kaplan: You mentioned in your prepared marks that the screening, you've seen an increase in screen in treatment in terms of use of Coralyn. I guess where are we in terms of the awareness of the prevalence of hyper cortisolism and the endocommunity now and in terms of the increase in screening?

Matthew Lee Kaplan: Joe, you mentioned and you prepared marks that.

Matthew Lee Kaplan: The screening, you've seen an increase in screening treatment in terms of use of chlorine. I guess, where are we in terms of the awareness of the prevalence of hypercortisolism?

Joseph K. Belanoff: Thank you, Matt, and good to hear from you. I really think we're just at the beginning of that. I think that the results that you're seeing in the second quarter really are not a function of the results that were released in the Catalyst Study in late June, but in July, we certainly have seen a pickup in interest. I think that's going to continue through the year, and I think ultimately, the treatment portion of the Catalyst Study will also be very meaningful. But the short answer to your question is, I think we're really just at the beginning of that.

Speaker Change: and the Endo community now and in terms of the increase in screening.

Joe Belanoff: Thank you, Matt, and good to hear from you. I really think we're just at the beginning of that. I think that the results that you're seeing in the second quarter really are not a function of what the results were released in the catalyst study in late June, but in July we certainly have started seeing it pick up an interest. I think that's going to continue through the year, and I think ultimately the treatment portion of the catalyst study will also be very meaningful. But the short answer to your question is I think we're really just at the beginning of that expansion.

Joseph K. Belanoff: Thank you, Matt. And good to hear from you. I really think we're just at the beginning of that. I think that the results that you're seeing in the second quarter really are not a function of what the results

Joseph K. Belanoff: who were released in the Catalyst Study in late June , but in July we certainly have started seeing a pickup in interest. I think that's going to continue through the year, and I think ultimately the treatment portion of the Catalyst Study will also be very meaningful. But the short answer to your question is, I think we're really just at the beginning of that expansion.

Matthew Kaplan: Okay, that's helpful.

Joseph K. Belanoff: And then, just staying on Quorum for a moment, what are you seeing in terms of generic quorum in the marketplace now?

Matthew Kaplan: And then just stay on Coralyn for a moment. What are you seeing in terms of generic Coralyn in the marketplace now?

Speaker Change: Okay, that's helpful. And then, and then just stay on Quorum for a moment. What are you seeing in terms of generic Quorum in the marketplace now?

Sean Maduck: Okay, I'm going to pass you over just to reintroduce you to Sean Medouc, who is the president of our endocrinology division. Hey Matt, thank you for the question. I guess that all answered two ways.

Joseph K. Belanoff: I'm going to pass you over just to reintroduce you to Sean Maduck, who is the president of our endocrinology department. Hey, Matt, thank you for the question.

Sean Madduke: I'm going to pass you over just to reintroduce you to Sean Maduck, who is the president of our endocrinology division.

Sean Maduck: Hey Matt, thank you for the question. I guess I'll answer it two ways. The first question is, what are you seeing in the marketplace? You know, the Teva product has been available in the channel for many months, so it's out there, but it has had very little impact on our business.

Sean Maduck: The first question is, what are you seeing in the marketplace? The Teva product has been available in the channel for many months, so it's out there, but it has very little impact.

Sean Maduck: Hey Matt, thank you for the question. I guess I'll answer it two ways. The first question is, what are you seeing in the marketplace? You know, the Teva product has been available in the channel for many months, so it's out there, but it has had very little impact on our business.

Matthew Lee Kaplan: And just one more question, maybe before I jump back in the queue, I guess, following the presentation of the Grace Open Label and Randomized Withdrawal results at recent conferences, what's been the feedback you've been getting from the Endo community so far?

Matthew Kaplan: and just one more question maybe before I jump back on the queue. I guess following the presentation of the Grace Open Label and Random Us, which were all results at the recent conferences, what's been the feedback you've been getting from the end of community so far?

Speaker Change: Okay, okay. And just one more question before I jump back in the queue. I guess following the presentation of the GRACE Open Label and Randomized Withdrawal results at the recent conferences,

Speaker Change: What's been the feedback you've been getting from the endo community so far?

William Guyer: I'd like to introduce you; we introduce you to Bill Gyer, who was our Chief Development Officer. Bill. Great, thank you for that question. Well, the reception from investigators and clinicians has been outstanding, to be honest. They were excited about all of the Relicorland results because we have a positive study, so we had our primary endpoint. But beyond that, we've seen that Relicorland hit almost every secondary and exploratory endpoint because we see a broad improvement across the broad range of signs and symptoms of Cushing syndrome. And these positive results give clinicians insight into what they should expect in their patients.

William Guyer: Again, I'd like to introduce you, reintroduce you to Bill Guyer, who is our Chief Development Officer. Bill. All right, great.

William Guyer: Again, I'd like to introduce you, reintroduce you to Bill Guyer, who is our Chief Development Officer. Bill? All right, great. Thank you for that question. Well, the reception from investigators and clinicians has been outstanding, to be honest.

William Guyer: Well, the reception from investigators and clinicians has been outstanding, to be honest. They were excited about all of the Reliquorrelent results because we had a positive study. So we hit our primary endpoint.

William Guyer: All right, great. Thank you for that question.

William Guyer: But beyond that, we've seen that Reliquorrelent has hit almost every secondary and exploratory endpoint because we see a broad improvement across the broad range of signs and symptoms of Cushing's syndrome. And these positive results give clinicians insight into what they should expect from their patients. Another key piece is, you know, that promise of what we had hoped to improve the safety profile, and they take away that due to Relic Horlant's unique mechanism of action, robust and broad efficacy was seen without Relic Horlant-induced AEs, like hypokalemia, vaginal bleeding, endometrial thickening, no adrenal insufficiency, and no QT prolongation. So, when you put that package all together, the clinicians were very pleased to see that what we promised within Relic Horlant was unique in its selectivity has borne out to show that in the GRACE study.

Gary Charles Robb: Unknown Executive, Gary Robb

Speaker Change: of Signs and Symptoms of Cushing's Syndrome, and these positive results give clinicians insight into what they should expect in their patients.

William Guyer: Another key piece is that promise of what we had hoped to improve on the safety profile, and they take away that due to relicorland's unique mechanism of action, the robust and broad efficacy was seen without relicorland induced aease like hypochylemia, vaginal bleeding with endometriol thickening, no adrenal insufficiency, and no qt prolongation. So when you put that package all together, the clinicians were very pleased to see that what we promised within Relicorland being unique and its selectivity has worn out to show that in the Gracious study.

Speaker Change: Another key piece is, you know, that promise of what we had hoped to improve on the SAGER profile, and they take away that due to Reliquorlin's unique mechanism of action, the robust and broad efficacy was seen without Reliquorlin-induced AEs like hypokalemia, vaginal bleeding with endometrial thickening, no adrenal insufficiency, and no QT prolongation.

Speaker Change: So when you put that package all together, the clinicians were very pleased to see that what we promised within Reliquorlin being unique in its selectivity has borne out to show that in the GRACE study.

Matthew Kaplan: Very helpful.

William Guyer: Very helpful. And I guess just one more question, Bill, while I have you is, I guess, as we look forward to the DAZLS results, what would be a clinically meaningful change in the ALS-FRS as we look forward to that?

Matthew Kaplan: And I guess maybe just one more bill while I have you is I guess as we look forward to the dazzle results, what would be a clinically meaningful change in the ALSFRS as we look to that. Yeah, so in talking with ALS experts, we feel that the functional rating scale, the ALS functional rating scale, we are powered to see a 2.4 point difference in the functional rating scale.

Speaker Change: Very helpful. And I guess maybe just one more, Bill, while I have you is, I guess, as we look forward to the DAZLS results, what would be a clinically meaningful change in the ALS-FRS as we look to that?

William Guyer: Yeah, so in talking with ALS experts, we feel that the functional rating scale, the ALS functional rating scale, we are powered to see a 2.4 point difference in the functional rating scale. And we believe that that is, and so do investigators and clinicians, that's a clinically meaningful change on the ALS functional rating scale. So we're powered to detect that difference, and it will be clinically meaningful.

Bill: Yeah, so in talking with...

Bill: ALS experts, we feel that the functional rating scale, the ALS functional rating scale, we are powered to see a 2.4 point difference in the functional rating scale, and we believe that that is, and so do investigators and clinicians, that's a clinically meaningful change in the ALS functional rating scale.

Matthew Kaplan: And we believe that that is in subtle investigators and clinicians; that's a clinically meaningful change in the ALS Functional Rating Scale. So we're empowered to detect that difference, and it will be a clinically significant difference.

Bill: So we're empowered to detect that difference and it will be a clinically significant difference.

Matthew Kaplan: Okay, thanks. Thanks. Thank you.

Matthew Lee Kaplan: All right. Thanks. Thanks again, guys.

Matthew Kaplan: Thank you, man. Thanks.

Operator: Thank you, Matt. Thanks, man. Please stand by.

Gary Charles Robb: Unknown Executive, Gary Robb

Operator: Will you stand by for our next question? Our next question comes from the line of David Amsellem. With Piper Sander, your line is open.

Operator: Will you stand by for our next question?

Speaker Change: All right, thanks. Thanks again guys.

Speaker Change: Thank you, Matt. Thanks, Matt.

David Amsellem: Our next question comes from the line of David Amselam with pipe of sand, or your line is open. Hey, thanks. So just had a few.

Speaker Change: Will you stand by for our next question?

Speaker Change: Our next question comes from the line of David Amsellem.

David A. Amsellem: Hey, thanks. I just had a few. First, regarding the CoreLim AG, can you talk about your thought process for bringing an AG into the marketplace, and how that plays into your thinking regarding the potential for one or two more generic entrants, in other words, Sun or Hikma? Just wanted to get your thought process there on the AG. That's number one. And then secondly, in terms of the new prescribers, are these coming from squarely in the endocrinology community or maybe adjacent to the endocrinology community, in other words, diabetologists?

Speaker Change: With Piper Sandler, your line is open.

David Amsellem: First, regarding the core limb AG, can you talk about your thought process for bringing an AG into the marketplace and how does that play into your thinking regarding the potential for one or two more generic entrance? In other words, son or Hickman just wanted to get your thought process there on the AG. That's number one.

David A. Amsellem: Hey, thanks, so just had a few. First...

David A. Amsellem: Regarding the core limb AG, can you talk about your thought process for

David A. Amsellem: bringing NAG into the marketplace and how does that play into your thinking regarding the potential for

David A. Amsellem: One or two more generic entrants. In other words, Sun or Hikma. Just wanted to get your your thought process there on the AG. That's number one.

David Amsellem: And then secondly, in terms of the new prescribers, are these coming from squarely in the end of chronology community or maybe adjacent to the end of chronology community, in other words, diabetes? Or maybe a better way of asking is, are you getting a lot of traction among diabetes, who historically have not prescribed the drug and have not screened for Cushions? So that's number two.

David A. Amsellem: And then secondly,

Speaker Change: In terms of the new prescribers, are these...

David A. Amsellem: Coming from.

David A. Amsellem: Squarely in the endocrinology community or maybe adjacent to the endocrinology community, in other words, diabetologists.

David A. Amsellem: Or maybe a better way of asking is, are you getting a lot of traction among diabetologists who historically have not prescribed the drug and have not screened for Cushing's? So that's number two. And then lastly, as you think about the evolution of this space, with prevalence being wider than what the community had thought it to be, how does that play into how you're thinking about the pricing of Relacorrelant? I know it might be early to ask that, but I think it's a fair question, just given that the prevalence of this space and our understanding of it are evolving.

Speaker Change: Or maybe a better way of asking is, are you getting a lot of traction among diabetologists who historically have not prescribed the drug and have not screened for Cushing's?

David Amsellem: And then lastly, as you think about the evolution of this space with a prevalence being wider than what the community had thought it to be, how does that play into how you're thinking about the pricing of relic or lint? I know it might be early to ask that, but I think it's a fair question just given that the prevalence of this space and our understanding of it is evolving. Thank you.

Speaker Change: Lastly, as you think about the evolution of this space,

Speaker Change: with a prevalence being wider.

Speaker Change: Than what the community had thought it to be, how does that play into how you're thinking about the pricing?

Rella Correlent: of Rella Correlent. I know it might be early to ask that, but I think it's a fair question just given that the prevalence of this space and our understanding of it is evolving. Thank you.

David Amsellem: Thank you, David. Thanks for those questions.

Joseph K. Belanoff: Thank you, David. And thanks for those questions. I think all of them really fall right into Sean Maduck's house.

Sean Maduck: I think all of them really fall right in Sean the Duke House, so I'm going to pass it over to him. Yeah, thanks, David. So I'm going to try to break these down. That's a lot of questions together. So I may have to check then, but I think I covered it.

Sean Maduck: Thank you, David, and thanks for those questions. I think all of them really fall right in Sean Maduck's house, so I'm going to pass it over to him. Yeah, thanks, David. So I'm going to try to break these down. That's a lot of questions together, so I may have to check them, but I think I covered it. So your first question was around the AG and sort of what drove our thinking around that. And the reality is that over time, given the availability of a generic in the market, that payers may mandate that their patients receive a generic drug. Right.

Sean Maduck: So I'm going to pass it over to him. Yeah, thanks, David. So I'm going to try to break these down. That's a lot of questions together, so I may have to check in. But I think I've covered it.

Sean Maduck: So your first question was around the AG and sort of what drove our thinking around that. And the reality is that over time, given the availability of a generic in the market, that payers may mandate that their patients receive a generic. Drove and making the AG available allows us, of course, to ensure that these patients and their prescribed physicians have continuity care and are still able to access the robust patient support services and physician support services that we provide.

Sean Maduck: So the first question was around the AG and sort of what drove our thinking around that. And the reality is that, over time, given the availability of a generic in the market, payers may mandate that their patients receive a generic drug. And making the AG available allows us, you know, Corcept to ensure that these patients and their prescribing physicians have continuity of care and are still able to access the robust patient support services and physician support services that we provide.

Sean Maduck: And making the AG available allows us, you know, Corcept to ensure that these patients and their prescribed physicians have continuity care and are still able to access the robust patient support services and physician support services that we provide.

Sean Maduck: The second part of your question then was, how does, I believe you have, how does this influence what might happen with other potential generics entering the market. I can't speak to what their specific plans are, but I will remind everybody that Teva announced their launch on January 19th, and by statute, any additional filer, any second filer, can enter six months after the first filer have launched, provided that they have the FDA approval. And the earliest possible date was July 19th, and that date has passed. And as far as we know, no, no, neither son nor Hickma has that the approved.

Sean Maduck: The second part of your question then was, how does, I believe you asked, this influence what might happen with other potential generics entering the market? I can't speak to what their specific plans are, but I will remind everybody that Teva announced their launch on January 19th. And by statute, any additional filer, any second filer, can enter six months after the first filer has launched, provided that they have FDA approval. And the earliest possible date was July 19th, and that date has passed. And as far as we know, neither Sun nor Hikma has the FDA approval.

Sean Maduck: The second part of your question, then, was how does...

Speaker Change: I believe you asked, how does this influence what might happen with other potential generics entering the market?

Speaker Change: You know, speak to what their specific plans are, but I will remind everybody that Teva announced their launch on January 19th.

Speaker Change: And by statute, any additional filer, any second filer, can enter six months after the first filer had launched, provided that they have the FDA approval. And the earliest possible date was July 19th, and that date has passed.

Speaker Change: And as far as we know, neither SAHN nor HICMA has FDA approved.

Sean Maduck: All right. So the third third part of the question was around new prescribers. And I guess how widely distributed are those across specialties. And I can tell you that. You know, we've continued to promote probably to endocrinologists and to other patients that we believe could be seeing patients with hypercortisolism within their practices. So we educate through our field force and through other initiatives. And we've seen new prescribers emerge in the diabetology space, the endocrinology space, as well as others.

Sean Maduck: Alright, so the third part of the question was around new prescribers, and I guess how widely distributed are they across specialties. And I can tell you that, you know, we've continued to promote broadly to endocrinologists and to other patients that we believe could be seeing patients with hypercortisolism within their practices. So we educate through our field force and through other initiatives. And we've seen new prescribers emerge in the diabetology space, the endocrinology space, as well as And then the last question was specifically about pricing. Can you please? Maybe restate what the specific question was around pricing.

Speaker Change: All right, so the third part of the question was around new prescribers, and I guess how widely distributed are those across specialties, and I can tell you that

Speaker Change: We've continued to promote broadly to endocrinologists and to other patients that we believe.

Speaker Change: Could be seeing patients with hypercortisolism within their practices. So we educate through our field force and through other initiatives, and we've seen new prescribers emerge in the diabetology space, the endocrinology space, as well as others.

David Amsellem: And then the last question was specifically about pricing.

Sean Maduck: Can you please maybe restate what the specific question was around pricing? Yes, sure. And I pause as I know is a mouthful of the in terms of the pricing just with this space, having a wider prevalent. How does that impact how you're thinking about pricing of relic orland. I guess what I'm trying to ask is pricing of Relic Orland going to be somewhat below what you're seeing what the AG for Corollum is priced at or the brand that's the most direct way I could ask it. That's a great question. Thank you. So right now we expect that pricing would be roughly in line with Corollum and there are real arguments.

Speaker Change: And then the last question was specifically about pricing. Can you please?

David A. Amsellem: Yeah, sure, and I apologize. I know it was a mouthful.

Speaker Change: Maybe restate what the specific question was around pricing. Yeah, sure. And I apologize. I know it was a mouthful. So in terms of the pricing, just in with this space,

David A. Amsellem: So, in terms of the pricing, just with this space, having a wider prevalence, how does that impact how you're thinking about pricing for Relic Oralint? I guess what I'm trying to ask is, is the price of Relic Oralint going to be somewhat below what you're seeing, what the AG for Coraline is priced at or the brand? That's the most direct way I could ask. That's a great question. Thank you.

Speaker Change: having a wider prevalence, how does that impact

Speaker Change: How are you thinking about pricing of Relic Oralint? I guess what I'm trying to ask is, is pricing of Relic Oralint going to be somewhat below what you're seeing, what the AG for Coraline is priced at or the brand? That's the most direct way I could ask it.

Speaker Change: That's a great question. Thank you. So right now we expect that pricing will be roughly in line with Forlump.

Sean Maduck: However, the relic Orland could be priced at a premium to Corollum given its favorable efficacy and safety profile.

Speaker Change: And there are real arguments, however, that roller coralline could be priced at a premium to coralline given its

Sean Maduck: Now, perhaps to your question around the expansion of the population, we recognize that Corlym and the future Rola-Corlym are high-priced drugs that are priced for, right now, a smaller patient population. We know that each market has a price threshold, though, and that a market with 2,000 patients is obviously different than one with 20,000 or 200,000. The hypercortisol market is definitely still growing, and when we know where we're at, our price will accurately reflect that market, and that's our social contract. That's something that we firmly believe in. Thank you, David.

David Amsellem: Now the question around the expansion of the population. I mean, we recognize that corollum and when the future relic Orland are high price drugs that's priced for right now, a smaller patient population. We know that each market has a price threshold, though, and then a market with 2,000 patients is obviously different than one with 20,000 or 200,000. The hypercortisolism market is definitely still growing. And when we know where we're at, our price will accurately reflect that market. And that's that's our social contract. That's something that that be friendly. Thank you, David. Thank you.

Gary Charles Robb: Unknown Executive, Gary Robb

Gary Charles Robb: We know that each market has a price threshold though and that a market with 2,000 patients is obviously different than one with 20,000 or 200,000.

Gary Charles Robb: The hypercortisol market is definitely still growing, and when we know where we're at, our price will accurately reflect that market. And that's our social contract. That's something that we firmly believe.

Operator: Thank you. Thanks, Steve. Please stand by for our next question. Our next question comes from the line of RK with HC Wainwright. Your line is open.

Operator: Please stand by for our next question.

David A. Amsellem: Thank you, David.

David A. Amsellem: Thank you.

David A. Amsellem: Thank you. Thank you.

R.K.: Our next question comes from the line of R.K. with H.C. Wayne Wright. Your line is open. Thank you. Thanks for taking my question. Sure.

Speaker Change: Please stand by for our next question.

RK: Thank you. Thanks for taking my question. So just on the quarterly revenue growth, I'm just trying to understand. You know, you said that some of the uptake that we could think about coming from ENDO was actually happening in July. So, going from where we are now, how should we think about the mix? And also, what are you taking into account when you are changing your guidance or you're upping your guidance from where it was at the end of the first quarter? Yeah, thank you for the questions.

Speaker Change: Our next question comes from the line of R.K. with H.C. Wainwright. Your line is open.

R.K.: So just on the quarterly revenue growth, I'm just trying to understand. You said that some of the uptake that you could think about coming from Endo, it was actually happening in July. So going from where we are now, and how should we think about the mix and also what are you taking into account when you're changing your guidance or you're not being your guidance from the end of first quarter. Yeah, thank you for the question.

R.K.: Thank you. Thanks for taking my question. Sure. So just on the quarterly revenue growth, I'm just trying to understand.

Speaker Change: Unknown Speaker Okay.

Speaker Change: You know, you said that some of the uptake that you that you we could think about coming from indoor. It was actually happening in July .

Speaker Change: So, going from where we are now,

Speaker Change: How should we think about the mix and also what are you taking into account when you are changing your guidance or you're upping your guidance from where it was at the end of first quarter?

Sean Maduck: Yeah, thank you for the question. This is Sean again.

Sean Maduck: This is Sean again. I think your question is related to sort of catalyst in diabetes. The reality is there's been very little to no impact from catalyst in our year-to-date results, and we have included modest benefit in our updated guidance.

Sean: Thank you for the question. This is Sean again. I think your question is related to catalysts and diabetologists. The reality is that there has been very little to no impact from catalysts in our year-to-day results, and we have included modest benefit in our updated guides.

Sean Maduck: That said, I do think that the results presented in ADA that Jo had highlighted are going to be increasingly meaningful over time, and that we could see more patients in the second half of the year than was initially expected.

Sean Maduck: And I think your question is related to catalysts and diabetologists. The reality is, there's been very little to no impact from catalysts on our year-to-day results. And we've included modest benefits in our updated guide. That said, I do think that the results presented at ADA that Joe highlighted are going to be increasingly meaningful over time and that we could see more patients in the second half of the year than initially expected.

Sean: That said, I do think that the results presented at the ADA that Joe had highlighted are going to be increasingly meaningful over time, and that we could see more patients in the second half of the year than was initially expected. When the results of the treatment arm of the study are available at the end of the year, I think a very meaningful change could take place.

Sean Maduck: When the results of the treatment arm of the study are available at the end of the year, I think a very meaningful change could take place. So we have all; we've taken all those factors into account. We take many factors into account. We look at our range, and the range that we've stated is our best.

Sean Maduck: When the results of the treatment arm of the study are available at the end of the year, I think a very meaningful change could take place. So we've taken all those factors into account. We take many factors into account when we look at our range, and the range that we've stated is our best. Thanks, Arkay.

Speaker Change: So, we have all, we've taken all those factors into account. We take many factors into account when we look at our range, and the range that we've stated is our best thinking.

R.K.: Thanks, okay.

Operator: Thank you. Please stand by for our next question.

Operator: Please stand by for our next question. Our next question comes from the line of June Lee with Truist. Your line is open.

Arcade: Thanks, Arcade.

Speaker Change: Thank you.

Speaker Change: Please stand by for our next question.

June Lee: Our next question comes from the line of June Lee, which yours, Yelana, is open. Hey, congrats on the strong quarter, and thanks for taking our questions. We have two questions. First is, what's the reason for the delay in Relocortland NDA submission for Q? And what's the rate-limiting step for that submission?

Speaker Change: Our next question comes from the line of June Lee with Truist. Your line is open.

Joon So Lee: Hey, congratulations on a strong quarter and thanks for taking our questions. We have two questions. First, what's the reason for the delay in Rella-Cortland's NDA submission to 4Q? And what's the rate-limiting step for that submission? And then the second question is regarding the phase four catalyst trial: how important is the outcome of part two in expanding the TAM? Specifically, you know, regardless of the outcome of part two in managing glucose levels, would the patient still need to be treated for hypercholesterolemia? Thank you.

June Lee: Hey, congrats on the strong quarter and thanks for taking our questions. We have two questions. First is, what's the reason for the delay in Rella Cortland NDA submission to 4Q?

June Lee: And then the second question is, regarding the phase 4 catalyst trial, how important is the outcome of the part 2 in expanding the TAM, specifically, you know, regardless of the outcome of part 2 in managing glucose levels, would the patients still need to be treated for hypercordalism? Thank you.

Speaker Change: And what's the rating rate limiting step for that submission? And then the second question is.

Speaker Change: Regarding the Phase 4 Catalyst Trial, how important is the outcome of Part 2 in expanding the TAM? Specifically, regardless of the outcome of Part 2 in managing glucose,

Joe Belanoff: I'll answer just this. The second question first, if you would mind, June, the answer is that we think that it's very meaningful, that we think that the problem with these patients, no, just to sort of back up, the average hemoglobin A1C in patients who entered the catalyst study was 8.8. And these are treatment patients who are treated by, you know, really in my estimation, but many others, the best diabetistologist in the country, using the best medications, including many who are taking GLP1s and so forth. These patients clearly have another problem. And in a quarter of them, it's hypercordalism.

Joseph K. Belanoff: I'll answer just this second question first, if you don't mind, June. The answer is that we think that it's very meaningful that we think that the problem with these patients is, just to sort of back up, the average hemoglobin A1c in patients who entered the Catalyst Study was 8.8. And these are patients who were treated by, really, in my estimation, but many others, the best diabetologists in the country using the best medications, including many who were taking GLP-1s and so forth. But these patients clearly have another problem. And in a quarter of them, it's hypercorazole. I mean, that clearly is an issue for them.

Speaker Change: I'll answer just this second question first, if you wouldn't mind June . The answer is that we think that it's very meaningful, that we think that the problem with these patients, just to sort of back up.

June Lee: The average hemoglobin A1c in patients who entered the CataList study was 8.8.

Speaker Change: And these are patients who are treated by, you know, really in my estimation, but many others, the best diabetologists in the country, using the best medications, including many who are taking GLP-1s and so forth.

Speaker Change: These patients clearly have another problem, and in a quarter of them, it's hypercorazole. I mean, that clearly is an issue for them.

Joe Belanoff: I mean, that clearly is an issue for them.

Joe Belanoff: Now, I think the treatment study is very meaningful. I think the question, you know, we have, you know, really high hopes and expectations that it's going to do, the medicine is going to do exactly what we think it's going to do. But I really do think that showing that these patients exist, which has really already shaken the heads of these diabetologists. And showing there's really something you can do about it, I think it's going to be very, very meaningful.

Joseph K. Belanoff: Now, I think the treatment study is very meaningful. I think the question, you know, when we have really high hopes and expectations, medicine is gonna do exactly what we think it's gonna do. But I really do think that showing that these patients exist, which has really already shaken the heads of these diabetologists, and showing there's really something you can do about it, I think it's gonna be very, very meaningful. I'm going to pass, just so Charlie can speak. Charlie Robb, who's our head of regulatory and chief business officer, will answer your, Yeah, hi, June. Um, yes.

Speaker Change: Now, I think the treatment study is very meaningful.

Speaker Change: I think the question, you know, when we have, you know, really high hopes and expectations, it's going to do, the medicine is going to do exactly what we think it's going to do. But I really do think that showing that these patients exist, which has really already shaken the heads of these diabetologists, and showing there's really something you can do about it, I think it's going to be very, very meaningful.

Charlie Robb: I'm going to pass, so Charlie can speak here, Charlie Robb, who has had a regulatory and chief business officer, who will answer your first question. Yeah, hi, Jane. Yes, in the course of, you know, we're just back against just a back of a little bit, any company including ours that's preparing to submit an MBAs and regular conversation with the FDA, a lot of information has exchanged, things are discussed. And after that back and forth, we decided that to include data from our gradient trial, which is to remind everyone it's fully enrolled and we'll have that date in the fourth quarter, but we decided to include that in the NDA submission and that date will be available in the fourth quarter, so that's when we'll be able to submit the NDA.

Gary Charles Robb: I'm going to pass just so Charlie can speak here. Charlie Robb who's our Head of Regulatory and Chief Business Officer will answer your first question.

Gary Charles Robb: Yeah, hi, June. Um, yes, during the course of, you know, we'll just back up a little bit. Any company, including ours, that's preparing to submit an NDA and regular conversation with the FDA, a lot of information is exchanged. And it was after that, back and forth, we decided to include data from our gradient trial, which is to remind everyone that everyone is fully enrolled, and we'll have that data in the fourth quarter. But we decided to include that in the NDA submission. And that data will be available in the fourth quarter, so that's when we'll be able to submit the NDA.

Gary Charles Robb: In the course of, just to back up a little bit, any company, including ours, that's preparing to submit an NDA, is in regular conversation with the FDA, a lot of information is exchanged.

Gary Charles Robb: Things are discussed.

Gary Charles Robb: And it was after that, back and forth, that we decided that...

Gary Charles Robb: to include data from our gradient trial.

Gary Charles Robb: which is to remind everyone is fully enrolled, and we'll have that data in the fourth quarter. But we decided to include that in the NDA submission, and that data will be available in the fourth quarter, so that's when we'll be able to submit the NDA. That's all there is to it.

Charlie Robb: That's all there is to it.

Joe Belanoff: All right, thank you. Thank you, Joon. All right, well listen, it's a late summer afternoon for everyone.

Gary Charles Robb: Thank you, June. All right. Well, listen, it's a late summer afternoon for everyone. Thank you for dialing in, and we will speak to you in a quarter.

Operator: Thank you for dialing in, and we will speak to you in a quarter.

Speaker Change: All right. Thank you.

Speaker Change: Thank you, June . All right, well listen, it's a late summer afternoon for everyone. Thank you for dialing in and we will speak to you in a quarter.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Goodbye.

Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker Change: Goodbye!