Good day. And welcome to the Corcept Therapeutics Conference Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Atabak Mokari, CFO. Please go ahead.

Hello, everyone. Good afternoon and thank you for joining us. I'm Atabak Mokari, Corcept's Chief Financial Officer. 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-Q with the SEC. Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties which may cause actual results to differ materially from those such statements expressed or implied. These forward-looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements. Our revenue in the second quarter of 2023 was $117.7 million, an increase of 14% compared to the second quarter of last year. To reflect that growth, we are raising our 2023 revenue guidance again to a range of $455 million to $470 million, up from $435 million to $455 million. Net income was $27.5 million, or $0.25 per share in the second quarter compared to $27.4 million, or $0.24 per share in the same period last year. Our cash and investments of $363.3 million at June 30th reflects the purchase of 6.6 million Corcept shares for $145.4 million during the quarter. I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update.

Thanks Atabak. In March 2018, we sued Teva Pharmaceuticals in Federal District Court to prevent it from marketing a generic version of Korlym in violation of our patents. Trial is set to begin next month on the 27th of September. As a reminder, Teva cannot dispute the validity of the two patents we are asserting against it. We assert the '215 patent and the '800 patent, which concern the safe coadministration of Korlym with a commonly prescribed class of drugs known as strong CYP3A inhibitors; issues determinative of these patents' validity were decided in our favor until the loss of the post-grant review challenge initiated by Teva. Teva’s only defense with respect to these two patents is that its proposed products would not infringe, a position we believe has no legal or factual support. The '214 patents are two of the four patents we are asserting against Teva. As I said last quarter, and in all of the calls we've held since this litigation began, we are supremely confident in the strength of our case. We are happy that our trial date is approaching. We look forward to our day in court. Why? Because the law and the facts are on our side. I’ll now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer.

Thank you, Charlie. The strong results of our commercial business in the second quarter reflect the early return on our substantial investment to stimulate physicians to better recognize and treat hypercortisolism. In the second quarter, we saw a continued increase in the number of patients receiving Korlym and in the number of physicians prescribing the medication. The business translation of more patients benefiting from Korlym treatment is a new record high in our quarterly revenue, and we expect our growth to continue. Korlym is an excellent treatment for patients with Cushing’s syndrome, and there are many eligible patients who have yet to receive it. Leading endocrinologists increasingly believe that there are considerably more patients with Cushing's Syndrome than was once assumed. Results of our ongoing CATALYST study will likely provide further evidence to bolster this belief and equally likely persuade physicians to begin identifying and providing effective treatment for a large group of patients with hypercortisolism whose disease currently goes undiagnosed. We are confident in the growth potential of our Cushing's Syndrome business and are raising our 2023 revenue guidance range again, this time to $455 million to $470 million. We're also very excited by the potential of our clinical development programs. Since inception, our research and development efforts have built on the hypothesis that cortisol modulation can be a powerful therapeutic mechanism in many serious disorders. Our proprietary compounds modulate cortisol effects by binding to the glucocorticoid receptor, or GR. The receptor is activated when cortisol levels are high. They do not bind to the progesterone receptor, and do not cause some of Korlym’s serious off-target effects. Interestingly, while our compounds modulate cortisol activity without modulating progesterone activity, they are not identical. Some cross the blood-brain barrier; others do not. Some perform best in models of solid tumors, while others are more potent in models of metabolic disease. Some appear to be tissue-specific, while others have more global effects. These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs with three of our proprietary selected cortisol modulators: relacorilant, dazucorilant, and miricorilant in ovarian, adrenal, and prostate cancer, ALS, NASH, and, of course, Cushing’s syndrome. We have additional compounds in clinical and preclinical development. In the next 12 months, we expect data from our GRACE, GRADIENT, and CATALYST studies, submission of an NDA for relacorilant in Cushing’s syndrome, completion of enrollment for our ROSELLA and DAZALS studies, and initiation of a Phase 2b trial for relacorilant in patients with NASH. This is a very exciting time for Corcept. We are evaluating relacorilant for the treatment of hypercortisolism in two Phase 3 trials: GRACE and GRADIENT. Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike Korlym, it does not bind to the progesterone receptor (PR for short) and so does not cause PR-related side effects, including termination of pregnancy, endometrial thickening, and vaginal bleeding. Through different mechanisms, relacorilant also does not cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym’s pivotal trial. Korlym-induced hypokalemia is a leading cause of Korlym discontinuation. Relacorilant’s Phase 2 efficacy and safety data were compelling. Patients experience meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing's Syndrome. There were no relacorilant-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced hypokalemia. The trial results were published in Frontiers in Endocrinology in July 2021. With enrollment in GRACE complete, we are focused on finishing the trial and preparing our NDA, which we plan to submit in the second quarter of 2024. Relacorilant has tremendous promise as a treatment for patients with all etiologies of endogenous Cushing's syndrome, and we are eager to make it available. Our second Phase 3 trial in hypercortisolism, GRADIENT, is studying relacorilant's effects on patients whose Cushing’s syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's Syndrome often experience less rapid decline, but their health outcomes are poor, including a higher risk of premature death. While we do not expect our NDA in Cushing's Syndrome to depend on data from GRADIENT, we do expect the study to produce valuable data about an etiology of Cushing's syndrome that affects many patients whose hypercortisolism frequently goes undiagnosed and untreated. I'm pleased to announce that our CATALYST study is progressing ahead of schedule. CATALYST is a 1,000-patient Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes. Patients diagnosed with hypercortisolism in the CATALYST study will choose to enter a randomized, double-blind, placebo-controlled study of Korlym. Many independent studies conducted over the last 15 years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologists in the United States helped us design and are participating in CATALYST, which will be the largest study of its kind. We have received very positive feedback from leading endocrinologists regarding this study and expect to complete enrollment in the fourth quarter, ahead of our previous estimate. Our oncology program is testing three anti-cancer mechanisms first postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis, the programmed cell death that chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effects of chemotherapy by suppressing apoptosis. In our successful Phase 2 trial in women with platinum-resistant ovarian cancer, the addition of our selective cortisol modulator relacorilant enhanced the effect of chemotherapy, likely by blunting cortisol’s anti-apoptotic effect. Relacorilant provided meaningful benefits to many of the women in our study. While these women’s diseases had progressed onto more previous lines of treatment, including previous taxanes, relacorilant appeared to re-sensitize the disease to chemotherapy's beneficial effects in some women. Those who received relacorilant intermittently the day before, on the day of, and the day after they received nab-paclitaxel exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received nab-paclitaxel monotherapy. Women in the intermittent relacorilant group also lived longer than those in the comparator arm, with a p-value approaching statistical significance. Our analysis to date indicates that 29% of the patients who took intermittent relacorilant were alive two years after study start versus only 14% who took nab-paclitaxel alone. Just as importantly, the women who received relacorilant plus nab-paclitaxel experienced no additional side effect burden compared to those who received nab-paclitaxel alone. The results from this study were recently published in the prestigious Journal of Clinical Oncology. Results have also been featured in podium presentations at the 2021 and 2022 European Society for Medical Oncology (ESMO) meeting and at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. ROSELLA, our confirmatory pivotal Phase 3 trial in platinum-resistant ovarian cancer, is enrolling patients. ROSELLA is designed closely to track a Phase 2 study and its goal is simply to replicate positive Phase 2 results in a larger group. We plan to enroll 360 women randomized 1:1 to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The primary endpoint is progression-free survival, with overall survival as a key secondary endpoint. We are conducting this study in collaboration with leading clinicians from the Gynecological Oncology Group in the United States and the European Network of Gynecological Oncology Trials Group in Europe. We are on track to complete enrollment by the end of the year. Leading gynecological oncologists have told us that, in their view, relacorilant’s potential benefit, improved progression-free and overall survival without increased side effect burden would constitute an important medical advance and that relacorilant plus nab-paclitaxel has the potential to become a new standard of care in women with platinum-resistant ovarian cancer. The second mechanism by which cortisol modulation improves usefulness is by blocking an important tumor growth pathway. Cortisol stimulation is 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 tumor switches to cortisol activity to stimulate growth. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. Our collaborators at the University of Chicago plan to begin a randomized placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer before these patients have had an initial prostatectomy this quarter. The third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune system, which 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 the effectiveness of these therapies. We are conducting a Phase 1b trial of relacorilant plus the PD1 checkpoint inhibitor pembrolizumab in patients with advanced adrenal cancer; these tumors produce excess cortisol, and pembrolizumab is rarely effective as monotherapy in treating this form of adrenal cancer. ALS, commonly known as Lou Gehrig's Disease, is a devastating illness with an urgent need for better treatment. DAZALS, our 198 patient randomized double-blind placebo-controlled Phase 2 trial of dazucorilant in patients with ALS, is briskly enrolling patients. Dazucorilant is a selective cortisol modulator that has shown great promise in animal models of ALS, improving motor performance and reducing neural inflammation and muscular atrophy. We are conducting this important study in collaboration with TRICALS, a leading ALS academic consortium in Europe. We recently added clinical trials right in the United States and are on track to complete enrollment in DAZALS by early next year. Finally, I'll turn to our program in NASH, a serious liver disorder that afflicts millions of patients in the United States. Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. In our prior NASH studies, patients who received 600 milligrams or 900 milligrams of miricorilant daily exhibited large rapid reductions in liver fat, but also substantial, albeit transient elevations of the liver enzymes, ALP and AST. The improvements in liver fat in these patients were greater and occurred much more rapidly than we had expected and are rarely seen over any period of treatment. Our ongoing Phase 1b dose-timing study, which evaluated a range of doses and dosing schedules of miricorilant, found that patients who received just 100 milligrams of miricorilant orally twice a week for 12 weeks experienced an approximately 30% reduction in liver fat and showed improvements in liver enzymes and markers of liver disease. These patients also experienced improvements in key metabolic to lipid measures, such as HOMA IR, serum triglycerides, and LDL. Importantly, miricorilant was very well tolerated. We plan to submit these results for presentation at a scientific conference and will initiate a Phase 2b trial in the fourth quarter. In conclusion, we are extremely optimistic about the future of Corcept. Our Cushing’s Syndrome business has tremendous growth potential and generates substantial profits, even as we invest in R&D advancing development programs. We are again raising our revenue guidance for this year and anticipate growth for years to come. Our CATALYST study holds great promise as the data generated will help physicians to improve the screening and treatment of patients with difficult-to-control diabetes caused by hypercortisolism, a population whose Cushing Syndrome frequently goes undiagnosed. For these patients, hypercortisolism is their disease, and diabetes is a symptom of their hypercortisolism. Our development programs are generating increasing evidence that validates our long-held belief that cortisol modulation has the potential to treat a wide range of diseases. Reducing cortisol activity is a straightforward and effective way to treat Cushing's Syndrome and can offer substantial benefits to patients with other serious disorders. Ovarian cancer, ALS, and NASH are current examples, but there will be others. In addition to relacorilant, dazucorilant, and miricorilant, we have many other proprietary selective cortisol modulators in our portfolio with potentially very different clinical attributes. In the next 12 months, we will see data from our GRACE, GRADIENT, and CATALYST studies in Cushing’s Syndrome. We will submit the relacorilant NDA in Cushing’s Syndrome, and we'll complete enrollment in large controlled studies of platinum-resistant ovarian cancer and ALS. We will also begin a Phase IIb study in patients with NASH. As I said, this is an exciting time for Corcept. I thank our dedicated, creative employees and loyal investors for making that possible. I'll stop here for questions.

Our first question comes from Matt Kaplan with Ladenburg.

Hi. Good afternoon. And thank you for taking the question. And congrats on the strong quarter. Can you give us some sense in terms of what drove the revenues in the second quarter and your confidence in increasing your guidance for this year as well?

Sure, Matt. I'm just going to reintroduce to the group, Sean Maduck, who is the President of our endocrinology division and runs our Cushing's syndrome business.

Hi, Matt, thanks for the question, and I'll just start by saying we're very pleased with the results. Your question was what drove it. It was driven by improved access and improved field execution. We're starting to see some early returns from our investments. Many of our investments have been on expanding the field and working to get our field more productive and efficient. So through that process this quarter, we've added both new patients and new prescribers, and we have more patients taking Korlym than ever before. Disease awareness continues to increase. And really, we're more confident than ever about the potential size of the Cushing’s Syndrome market. For the remainder of the year, our belief is just a fraction of hypercortisolism patients have been identified and treated. And over the coming months and quarters, there are going to be many more.

Got it. That's helpful. And just looking at your pipeline with GRACE completing enrollment and GRADIENT to complete in the near term. Can you help us set expectations in terms of what we're to expect for GRACE and GRADIENT as they read out perhaps next year?

Yes. Let me introduce you again to Bill Guyer, who runs all of our development here, Chief Development Officer. Bill, comment.

Great. Thank you, Matt, for that question. So as we have now completed enrollment for the GRACE trial, the investigators and we are very excited because of that. And now we're in the plans of submitting that NDA. And we've been working on that NDA since last year. And as we collaboratively work with the FDA, we're going to be developing and submitting all of our studies. The NDA will include many different studies. It will include the full Phase 2 data from a safety and efficacy perspective, the GRACE study from a safety and efficacy perspective, the GRADIENT trial from an integrated safety perspective, as well as our long-term extension study, which has been ongoing for over five years, where we have patients on relacorilant doing well for over five years. We're also going to include many other new recently presented and published data that we're excited to include in the NDA. One of those being we just completed a thorough QT study, where we evaluated the Heart QT interval and looked at relacorilant and saw no effects on the QT interval. That would make this the only drug in Cushing’s Syndrome that does not affect QT interval. So that's exciting news as we have completed that study. We've also seen published preclinical research citing how relacorilant can uniquely shrink tumors in tissue cultures. Those tumors have also shown two published case reports highlighting similar clinical benefits of relacorilant in patients. This is a differentiating factor because mifepristone was also used in those preclinical studies and saw no change in pituitary tumors. Finally, we presented new data from our Phase 2 trial looking at coagulopathy parameters, which was important because Cushing's Syndrome patients are at high risk for developing hypercoagulopathy events. Relacorilant showed no effects on those coagulopathy parameters and would be the only drug in the Cushing syndrome space to have no effect on hypercoagulopathy patterns. All of this data makes me confident in the benefit relacorilant can bring to patients and confident as we proceed towards our NDA in the coming year.

Great. And just a quick follow-up on that. Where are you with the manufacturing, and is manufacturing at all a rate-limiting step?

Manufacturing is not a rate-limiting step, Matt. And we'll certainly be ready to have a commercial supply when and if our NDA is approved.

I have one final question before I rejoin the queue. The CATALYST study is progressing ahead of schedule. Do you have an idea of what percentage of the patients you are screening for hypercortisolism are among those difficult-to-treat type 2 diabetes patients, based on the study's design?

Yes, Matt. I understand the question. I'm going to hand you back to Bill.

So CATALYST is building on a tremendous amount of research already generated with multiple different studies. I can cite all the studies and send you all the references. Many of those studies are in hundreds of patients. And in those independent studies over the past 15 to 20 years, we found that hypercortisolism is higher than the normal general population. I would guesstimate it to be around 10% to 20% for those patients who have difficult-to-control diabetes. And with CATALYST, this would be the landmark study because it is the largest study of its kind, evaluating 1,000 patients with type 2 diabetes who are difficult to control. We are doing a simple test of just on the DST. All of our investigators are part of this and are highly motivated, which is why screening is ahead of schedule. Thus far in the CATALYST study, even though it's early, I would say that the results so far are mirroring what we've seen in prior published studies.

Our next question comes from the line of Edward with Canaccord.

Hi, thanks for taking the call. Yes, congrats guys on such a strong quarter, really great. I have to ask you, and I guess this goes in the same vein of it being a really strong quarter and just the additional impact in the sales efforts really kind of is what you attribute that to. But I see that the European Society of Endocrinology has updated their practice guidelines on the treatment of adrenal adenoma, and I just wanted to find out what the implications are there? I think it's been a while since we've been updated. So just want to understand what the implications could be there for usage of Korlym.

Good, Edward. Thank you for the question, and I'm going to direct it to Sean again.

Yes. Ed, thanks for the question. Just adding on Bill just spoke; there's been mounting evidence over time that this illness is more prevalent. The European guidelines that were just updated are just another example of the evolution of the mindset around hypercortisol. Endocrinologists recognize that hypercortisolism is more prevalent than one thought. These guidelines encourage physicians to look harder for the disease, which is great. The guidelines also highlight the use of the relatively simple dexamethasone suppression test, or the DST, as a testing standard, which is going to support increased screening. So these guidelines will influence and increase both screening and diagnosis of hypercortisolism patients.

Our next question comes from the line of David Amsellem with Piper Sandler.

Thanks. I have a few questions. First, I wanted to ask about miricorilant and NASH. I know you will present data at medical meetings, but regarding the Phase IIb trial, could you discuss its design? Will liver biopsies be included in the trial? Are you considering this more as a Phase 2/3 trial, or should we expect that a full Phase 3 program will follow this Phase IIb? My second question is about the strategic direction for miricorilant. Are you planning to seek a partnership in the future, or do you intend to retain it for commercialization? How does it align with your overall business strategy, especially considering the other cortisol modulators you are evaluating that have not been disclosed?

Yes. Thanks, David. I understand your two questions. Bill, would you first describe the Phase IIb miricorilant study, and then I'll discuss the business possibilities.

Absolutely. Thank you for that question. So as we progress towards our Phase IIb program, let me back up a little bit. One, we just completed a great advisory board at the EASL conference, which is the European conference for the study of liver disease. We met with the top hepatologists in the world who have done research for every molecule in the NASH space for the past decades, and I've known them for many decades as well. As we reviewed all the Phase 2a data from our original study and all the Phase 2b and Phase 1b data, they were really impressed by that. They helped guide us in designing our Phase 2b trial. So that was really encouraging as we move forward. Our Phase IIb trial right now is a BC confirmed NASH study in patients with NASH. This study will be a double-blind, placebo-controlled trial, evaluating 150 patients randomized to miricorilant 100 milligrams twice weekly or placebo for 48 weeks. This is intended to be a Phase IIb study, and based upon those results, we will progress and design a Phase 3 trial.

And David, the second question is an interesting one. For a variety of reasons, particularly for those who have followed Corcept for a long time, and as you know, most of the things we have worked on starting with Cushing's syndrome have been orphan diseases, niche markets with a very obvious clinical need, but to a relatively small group of patients. NASH is, of course, a different story. The number of people in the United States with fatty liver disease is very large, and a sizable percentage of them have NASH and progress to worse conditions. So it's a big market. I don't know if 'primary care market' is the right way to describe it, but there's certainly a market with many, many patients in it. Now, is this something that we can do on our own as we have with the other diseases we've looked at, or is this a disease space where we will need to partner? I don't really know the answer to that at this time. What I will tell you is that we are not in need of anyone else's money to support the development plan. So if we decide that commercialization is better with a partner, we will go in that direction. I think we're in the lucky space because of our profitable business that we can take this as far as we want. Should we partner, we'll be in a place where it's clearly advantageous for us to do so. I’ll end with a simple answer: that decision has not yet been made.

Okay. That's helpful. If I might sneak in an additional question. Just on CATALYST. As you get learnings from the study and particularly the answers that you're looking for, which indicate that Cushing's syndrome and hypercortisolism is more prevalent and raising awareness among diabetologists. Do you think about calling on a sizable group of diabetologists in your rollout, and broader commercialization of relacorilant? In other words, is this going to be a bigger, splashier, and more expensive wider launch into a broader group of physicians?

Sean?

Yes. Thank you for the question. Look, we're in the process of really working through that now to understand what the most effective way will be for us to launch relacorilant. We recognize that these patients are more than just in endocrinology practices. Diabetologists, in general, are endocrinologists, but there are also cardiologists and primary care physicians throughout the country. We are working on scalable ways to get this message to those physicians so they can be educated on it.

I appreciate the question, David, particularly because we have been thinking about that. I think at some point, maybe a decade ago, we thought that the patients with Cushing's syndrome were likely to be treated by a very, very small number of endocrinologists. We do not think that is true anymore. We believe they are distributed to a much larger group, and making sure that these patients get optimal treatment is really our ethos.

Our next question comes from the line of Roanna Ruiz with Leerink.

Hi. Good afternoon, everyone. So I have a couple of follow-ups on your revenue guidance for a second. I was curious, what are some of the pushes and pulls that could get Korlym revenues closer to the higher end or the lower end of this range in your view?

Sean, please take that.

Yes. Thank you for the question. Our guidance is pretty simple; it is driven by the number of patients on the medicine. We have more patients taking Korlym than ever before, and we expect that there will be more in the future. We have a number of initiatives underway, and we expect them to impact the second half of the year. The more patients that are prescribed Korlym, the higher the end of the range will be. If it’s fewer, it will be on the lower end.

Got it. Okay. I wanted to ask a bit about your field force. I know you've reached a target of 60%. Are you thinking of possibly expanding that later this year or maybe into next year? And what type of launch metrics are you looking forward to help you make that kind of decision?

Sean, please.

Yes, it's a great question. I'll start by saying we're always evaluating the effectiveness of the team and looking to see what is the appropriate size. Stepping back in time a little bit, we felt it was important for us to maintain the stability of that team through the pandemic. However, over the last year, we've taken a hard look, and that’s where we've made changes. We've strengthened and streamlined our training program to make our current clinical specialists more productive, as well as our new clinical specialists more productive more quickly. We are currently in the mid-50s, and we are continuing to add clinical specialists throughout the country. Right now, our target is 60%, but we’re unlikely to stop there. If we continue to find top talent, we will add them to the team. We’re continuing to evaluate what the future looks like and will determine if we need to go beyond that.

Our next question comes from the line of Joon Lee with Truist.

Hi. Congrats on a strong quarter. I’m particularly intrigued by your Phase IV CATALYST study of Korlym in difficult-to-treat diabetics. How are you making the determination of hypercortisolism and advancing them to the randomized portion of the trial? And how deployable is that screening for hypercortisolism by generalists and endocrinologists who treat diabetics? Lastly, what is the endpoint in the randomized portion? And is the result there sufficient to get a labeled indication for diabetes? I have a follow-up.

Yes. Joon, first, welcome back. Nice to hear from you. Bill is the best person to answer all of that information. So I'm going to turn it over to him.

So when we look at CATALYST, we designed it specifically again and collaboratively with the top diabetologists and endocrinologists. We aimed to make this as simple and easy as possible. We have deployed a simple test of one DST, the dexamethasone suppression test, and are looking for patients with a DST greater than one. Those are the patients who are then positive and qualify for screening to enroll in the randomized, placebo-controlled trial of Korlym. In that trial, the primary endpoint is to look at the difference between glucose control in Korlym and that of placebo. Regarding the question of whether it will change the label of Korlym, it's already consistent with the label of Korlym because, if you look at the Korlym indication, it is indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes.

I just want to clarify this: all of these patients' disease is hypercortisolism, and diabetes or glucose intolerance is secondary to their hypercortisol. That's what is causing their hypercortisolism. In some cases, there's no difference, except for a degree of illness between these patients, and some of them can be quite ill. That distinction is important. These medicines, whether Korlym or relacorilant, are not for diabetes in general; they are specifically for the treatment of hypercortisolism, where diabetes appears as a prominent manifestation.

To answer your question about whether we would repeat a study for relacorilant, I see no reason to repeat this study. I see CATALYST as a landmark study that would easily apply to relacorilant. I’ll remind you, we are looking for an indication for hypertension and diabetes, not just diabetes.

Our next question comes from the line of Swayampakula Ramakanth with HC Wainwright.

This is RK from HC Wainwright. Most of my questions have been answered, but I have a quick question on clinical data expectations for the rest of this year.

I'm sorry. I didn't quite understand your question, RK. I apologize.

I'm just trying to understand what sort of clinical data we could expect in the next year, from here to the end of the year.

Yes, I understand your question now. Bill, could you please respond to that?

As I look at all the studies that are ongoing, the one study that we plan to submit to a conference in the fourth quarter of this year would be the NASH Phase Ib data. We plan to present that data hopefully at that conference. The CATALYST study will be close; we're ahead of schedule. I would estimate it's probably first quarter of next year, but we could see results from those screening and prevalence studies later this year in December.

I just want to underscore that. I think what you can count on is the Phase Ib results in NASH; we will have that, but everything else falls into the next year, off in the early part of next year, but in 2024.

Our next question comes from the line of Alan Leong with Bio Watch.

Hey, everyone. Glad to be here and congratulations on the ongoing work.

Well, Alan, wonderful to hear from you. What might we help you with today?

Well, a few questions, and thank you for your generosity. Can you talk about the dynamics of safety and efficacy telegraphed in regard to miricorilant?

I'm going to repeat this question. The question was what have we learned about the dynamics of miricorilant in terms of efficacy and safety? Bill, could you talk to that?

Three pieces there. We've reviewed the Phase IIa data, again, using 600 to 900 milligrams. We saw those dramatic liver fat reductions in a month, corresponding with rises in liver enzymes. That allowed us to then explore various lower doses and different dosing regimens in Phase Ib. As we studied various dosing regimens, we determined the rapidity of liver fat reductions. When we reviewed all of the data with our top advisers just about a month ago, we determined that rapid reduction in liver fat is tied to that rise in increasing free fatty acids, which then causes mitochondrial dysfunction, leading to that liver enzyme irritation and elevation. That’s key because we also saw that if we can slow that down, and we saw that with the 100-milligram twice-a-week dose, we saw a steady decline up to 12 weeks and a 30% reduction in liver fat with no rises in ALT or AST. We actually saw decreases in those liver enzymes. That's what we've learned. We've done many analyses looking at the slope of decline; the percentage of decline matches up that it is tied to the rapidity of liver fat reduction. We believe we've solved that problem, which is why we're advancing to Phase IIb.

The next set of questions are the following three programs. Which do you think has the greatest gap in understanding from your audiences that you could delve into, and see that there is a bit of a need for additional education? Feel free to split the investor community versus the life science specialists, such as ovarian cancer versus ALS.

I just want to repeat your question. The question was, of our programs, which do we think is least recognized by the investor community? If that's a distillation of your question, I understand. One thing that’s surprising to people until they really dig into the science—and as you know, I'm sort of a recovering academic, so I'm really all about the science—is how broad a platform cortisol modulation is. Cortisol impacts every tissue in the body, and it really has the potential to affect many disease states. It's somewhat obvious why a drug like Korlym or relacorilant would be effective in Cushing's syndrome. However, it is initially a little less clear why it might be effective in a neurologic disease like ALS or a variety of cancers. I think the interesting point for us is that individual investors seem to appreciate parts of the story individually. However, I hope to see over time that people can connect all of those things because they are indeed interconnected. Every four years, we conduct a conference with all of our collaborators. We have many academic collaborations at any given time—35 to 40 of them—so they're all over the world, in pre-clinical and clinical arenas. When we bring these people together, many times they are unaware of the other work that people are doing, even though they are all working in cortisol modulation. It's our mission to ensure people fully appreciate this entire platform, and I hope that, over time, even investors, when they have the time, can fully appreciate the global potential of these programs.

The future is bright for both of us.

Okay, Alan. And I think with that, we're out of questions. So I look forward to talking to everybody three months from now and hope you enjoy the rest of your summer. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.