CORT (2020 - Q3)

Good day, and welcome to the Corcept Therapeutics Conference Call. Today's call is being recorded. [Operator Instructions] And at this time, I would like to turn the call over to Charlie Robb. Please go ahead. Charlie

Thank you. Good afternoon, everyone. I am Corcept's Chief Financial Officer. Today, we issued a press release announcing our financial results for the third quarter and providing a corporate update. A copy is available at corcept.com. Complete results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available through November 17, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 Internationally, passcode will be 6800706. Statements made 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 differ materially from those such statements expressed or implied. These risks and uncertainties include, but are not limited to, our ability to operate our business and achieve our goals during the COVID-19 pandemic and thereafter, including our ability to generate revenue and cash reserves sufficient to fund our commercial operations and development programs; the availability of competing treatments, including generic versions of Korlym; the initiation or outcome of litigation; our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Korlym; and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight, and other requirements; and the impact of the COVID-19 pandemic on our employees, consultants, and vendors as well as physicians, patients, insurers, regulators, and practice of medicine generally. These and other risks are set forth in our SEC filings, which are available at our website and the SEC's website. On this call, forward-looking statements include those concerning our revenue guidance, cash flow and expected growth; our stock repurchase program and its intended funding process, the impact of the COVID-19 pandemic on our commercial operations, financial performance, clinical development programs, physicians, payers and patients and expectations regarding our financial performance and clinical development program after the COVID-19 pandemic is brought under control; physician awareness of hypercortisolism and the selection of Korlym as the optimum medical treatment; the timing, cost, and outcome of litigation, including our lawsuits against Teva Pharmaceuticals and Sun Pharmaceuticals and Teva's challenge to the validity of one of our patents from the Patent Trial and Appeals Board; the scope and protective power of our intellectual property; the benefits of orphan drug designation; the progress, enrollment, timing, design, and results of our clinical trials; and the clinical and commercial attributes of relacorilant, exicorilant, miricorilant, and our other selective cortisol modulators. We disclaim any intention or duty to update forward-looking statements. Revenue for the third quarter was $86.3 million, a 6% increase in the third quarter of 2019. Third quarter GAAP net income was $21.6 million compared to $26.3 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets together with related income tax effects, non-GAAP net income in the third quarter was $30 million compared to $37.8 million in the third quarter of 2019. Our cash and investments were $444.2 million on September 30, an increase of $34.7 million from June 30. Upon consideration of our strong financial position and prospects, our Board of Directors has approved a program running through September 30, 2021 to repurchase up to $200 million of our common stock. We will determine the timing and size of any repurchases based on market condition, our stock price, and other factors. We believe revenue from our Cushing’s syndrome business, together with our cash on hand, will be sufficient to fund our commercial activities in our current and planned clinical development and drug discovery programs, as well as our program to repurchase $200 million of our common stock. Now, a brief legal update. In March 2018, we sued Teva Pharmaceuticals in Federal District Court to stop it from marketing the generic versions of Korlym in violation of our patents. Our lawsuits stayed final FDA approval of Teva's proposed product for 30 months, a period which ended on August 1. Discovery is underway. Originally, trial is set to begin February 2, 2021. Last month, the Court vacated that date and ordered the parties to complete trial preparations by March 17, 2021. A new trial date has not been set. It could take place any time after March 17. Teva has also challenged the validity of one of our patents, the 214 patents, in a proceeding known as a post-grant review, or PGR, before the U.S. patent office's Patent Trial and Appeal Board, or PTAB. As many of you know, oral argument in matter was heard on September 2. We expect the PTAB to embrace this decision on or around [ph] November 19. The losing party may appeal with the Federal Circuit Court of Appeals, during which time the patent will remain [Technical Difficulty]. It is important to note that Teva is barred from challenging the validity of 214 patent in the District Court case using argument to raise or could have raised in the PGR. While Teva’s attorney will embattle and try to beat some anyway, the rules are intended to prevent Teva from getting its second bite at that apple. In any instance, appeal to the Federal Court usually takes about 12 to 16 months to resolve. If such an appeal takes place, the sooner we expect definitive resolution of the PGR is the fourth quarter of 2021. Sun Pharmaceuticals is also seeking to market generic Korlym. Our lawsuit against Sun has stayed final FDA approval of Sun's proposed product till the early December 8, 2021, that is December 8 of next year for a decision by the District Court if the patents we have asserted against Sun are invalid, unenforceable, or not infringed. Our dispute with Korlym is separate from our litigation against Teva and is following its own timeline. Markman hearing in the Sun case was set for November of this year. The set date has been vacated and a new date has not been suggested. In addition, no trial date has been set. Predicting the timing of any District Court litigation is difficult and the possibility of the waves caused by the COVID-19 pandemic compounds the problem. The Court has vacated our original trial date with Teva but has not set a new one. Whenever this trial takes place on a new date, we look forward to putting our patents [ph] before the judge. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?

Thank you, Charlie. The challenge posed by the COVID-19 pandemic underscores just how fortunate Corcept is to have a stable commercial business profitable enough to fund our increasingly broader advanced clinical development programs. We are currently testing molecules from our portfolio of proprietary, selective cortisol modulators in two Phase 3 Cushing’s syndrome trials; one Phase 3, one Phase 2, and two Phase 1b oncology trials; and two CNGB3 Phase 2 trials in metabolic disorders. These trials will generate important data next year and into 2022 even as additional novel molecules are into development. I know of no other company our size that combines commercial success with such diverse and promising clinical activities. I thought we need to tell you these are difficult times for everyone. The COVID-19 pandemic has caused many individuals, including physicians and patients to protect themselves from infection from [indiscernible] by limiting their exposure to other people. Patients are reluctant to leave their homes even to see their physician. Many medical practitioners have barred [indiscernible] in-person visits by commercial representatives. This reduction in face-to-face interactions make every aspect of medical care more difficult, especially for complex serious conditions such as Cushing’s syndrome. We are doing what we can to help. Our commercial team is providing ways to support physicians by video and teleconference. Physicians have increased their use of telemedicine and have adapted their in-office procedures to reduce the risk of infection. However, these measures are aimed at increasing face-to-face type of care. Diagnosing and treating the patients with Cushing’s syndrome requires more face-to-face interactions between patients and physicians. Nevertheless, patients who were using Korlym before the pandemic are highly motivated to continue to use. Despite the current pandemic obstacles, we continue to enroll new patients and add to our roster of Korlym subscribers, albeit at a medium pace for one reason, for limited and effective treatment that’s greatly improved the lives of many patients with Cushing’s syndrome, a life-threatening chronic illness. Pandemic-related changes in medical practice and patient behavior modestly reduced awareness this quarter, but the foundation of our business and effective medication promoted by a dedicated commercial team that could be an [indiscernible] patient approach have been rock solid and supports to benefit from growth once conditions improve. As I referred to on prior calls, there are many patients who could benefit from Korlym who have not yet received it. Our plan and success of Korlym are co-related and has the potential to benefit many more. Stock repurchase program we announced today reflects our Board’s confidence and fundamental strength of our business. Most important use of our cash is to fully fund our commercial operations and our increasingly broad clinical development programs. Before we [indiscernible] our stock repurchase program allows us to repurchase our stock when we think it’s undervalued, like it has been diminishing [ph] now. As many of you know, we are evaluating relacorilant, our planned successor to Korlym for patients with Cushing’s Syndrome in two Phase 3 trials. Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effect by competing with cortisol, a glucocorticoid receptor, GR for short. Unlike Korlym, it does not bind with progesterone receptor, PR, which means it does not cause off-target effects, including termination of pregnancy, endometrial thickening, vaginal bleeding caused by affinity to that receptor. By a different mechanism, relacorilant also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym's pivotal trial. Korlym-induced hypokalemia is a leading cause of Korlym discontinuation. Korlym’s Phase 2 clinical data was clinically positive. Patients experienced meaningful improvements in hypertension and glucose control as well as a variety of other signs and symptoms of Cushing's syndrome. There were no relacorilant-induced instances of endometrial thickening, vaginal bleeding, and also no drug-induced hypokalemia. Our poster presenting these results can be found at the Investors/Past Events tab of our website. We expect relacorilant's Phase 3 GRACE trial to serve as the basis for our NDA submission in Cushing's syndrome. We continue to enroll patients with any etiology of Cushing's syndrome although slated to begin before the pandemic, and it slowed its pace. We expect to submit our NDA in the second quarter of 2022. Last quarter, we dosed the first patient in relacorilant's second Phase 3 trial for patients with Cushing's syndrome, the GRADIENT trial. GRADIENT is specifically studying relacorilant's effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome, although experienced a less rapid decline, but ultimately their health outcomes are poor. GRADIENT is the first controlled study in patients with this type of Cushing's syndrome. We expect these findings will contribute to the optimal treatment of these patients. Participants in GRADIENT will receive either relacorilant or placebo for 22 weeks. The primary endpoints are statistically significant improvement in hypertension or glucose metabolism. All the other common manifestations in Cushing’s syndrome will also be measured. Planned enrollment is 130 patients at sites in the United States and Europe. Many of the investigators who are participating in GRACE will also participate in GRADIENT. You can find our poster presentation of GRADIENT’s design at the Research and Pipeline/Other Patients tab on our website. Our oncology program has originated in theories populated by investigators at University of Chicago more than 10 years ago and now consists of four clinical trials, two of which will produce data in the first half of next year. Our program is examining each of these new mechanisms by which cortisol modulation may help treat patients with solid tumors. Cortisol suppressing apoptosis, the programmed cell death chemotherapy is intended to induce. There are compelling preclinical interim data suggesting that relacorilant can help chemotherapy with its full potential, by reversing cortisol's anti-apoptotic effect. We are testing this hypothesis in patients with metastatic ovarian cancer and metastatic pancreatic cancer. We initiated these trials following encouraging results on our Phase 1/2 trial of relacorilant combined with nab-paclitaxel, Celgene's drug Abraxane. Tumors in seven of 25 patients with metastatic pancreatic cancer and in five of 11 patients with platinum-resistant ovarian cancer either shrink or stop growing for 16 weeks or longer. Two patients with metastatic pancreatic cancer exhibited tumor shrinkage for 65 weeks. All patients had experienced gene progression during multiple prior lines of chemotherapy, including the treatment of metastasis. We presented these results in ASCO in 2019. You can find our poster at Research and Pipeline/Publications page on our website. In order to begin enrolling patients in RELIANT, 80 patients were enrolled in Phase 3 trial of relacorilant plus nab-paclitaxel and patients with metastatic pancreatic cancer. Each patient will receive relacorilant plus nab-paclitaxel with primary endpoint being subjective response rate with secondary endpoints including progression-free survival for the duration of response. We expect to conduct an analysis of results from RELIANT’s first 40 patients in the first half of 2021. The expected response rate of nab-paclitaxel monotherapy and patients with metastatic pancreatic cancer is zero. We believe sufficiently positive results in RELIANT would support accelerated approval. In July, we completed enrollment in our controlled Phase 2 trial in patients with advanced ovarian cancer. 178 patients were randomized to receive nab-paclitaxel, in either continuous dosing of relacorilant, intermittent dosing the relacorilant, or placebo. The primary endpoint is progression-free survival with secondary endpoints, including objective response rate for the duration of response. We expect results of the study in the first half of next year. Cortisol activates and reduces inflammation and suppresses the immune system, which is why synthetic cortisol is used to treat autoimmune and inflammatory disorders such as rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis. Importantly, by suppressing the immune system, cortisol also diminishes the effectiveness of immunotherapy in treating patients with solid tumors. In September, we initiated open-label Phase I-b trial of relacorilant, plus the PD-1 checkpoint inhibitor, pembrolizumab, Merck’s drug, KEYTRUDA in patients with advanced adrenal cancer and tumors produced excess cortisol. These patients with severely affected adrenal cancer can have Cushing’s syndrome, a very bad combination. We believe that cortisol in excess may also interact and counteract the intended effect of pembrolizumab, which is rarely effective as monotherapy in these patients. By trial evaluating the relacorilant, it can treat these patients with Cushing’ syndrome by reducing the effects of excess cortisol activity and by reversing cortisol-induced immune suppression, also allows pembrolizumab to achieve its full cancer-killing effect. Our posters at this year’s ASCO and AACR meetings present preclinical and clinical biomarker data supporting our hypothesis. You can review them at Research and Pipeline/Publications tab of our website. We plan to enroll 20 patients in this trial at five sites in the United States. The primary endpoint is objective response rate with secondary endpoints including progression-free survival for the duration of response. Investigators at the University of Chicago have shown that cortisol stimulates tumor break in patients with castration-resistant prostate cancer. Findings has been confirmed by researchers at Memorial Sloan Kettering Cancer Center. Before we explain why patients treated with widely prescribed androgen receptor antagonist can be [indiscernible], the price of androgen stimulation, and tumors often utilize cortisol as a growing pathway. Our hypothesis is that adding a cortisol modulator in androgen deprivation therapy [indiscernible]. We’re conducting a Phase I-b trial of our selected cortisol modulator exicorilant, combined with enzalutamide in patients with castration-resistant prostate cancer and expect to identify the dose regimens suitable for advancing to wider controlled study in the first quarter of 2021. I’ll conclude with an update of our programs in metabolic diseases. In the United States, 6 million people [indiscernible] medications such as olanzapine; Eli Lilly's drug, Zyprexa, and Risperdal -- J&J’s Risperdal for treatment conditions such as schizophrenia, bipolar disorder, and major depression. While these drugs are very effective, they have speed breaks in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic strokes. Each of the patients can gain a weight of 50 pounds and the life expectancy decreased the average by 20 years, due in part to excess cardiovascular events such as heart attacks and strokes. We have completed three double-blind, placebo-controlled clinical trials in healthy subjects in the total administration of cortisol modulator reduces dangerous metabolic adverse effects. Two of these trials [indiscernible]. Our positive results were published in the Journal of Advanced Therapy and Obesity in 2009 and 2010. Unfortunately, Korlym which is [ph] active ingredient in the abortion pill cannot be advanced with such a prevalent disorder. Miricorilant, by contrast, is not the abortion pill and can be advanced for this use. Last quarter, we completed a trial in which healthy subjects received olanzapine with either 600 milligrams of miricorilant or 900 milligrams of miricorilant or placebo for 14 days. Study participants who received miricorilant gained significantly less weight than those who received placebo. In addition, they exhibited a smaller increase in triglycerides and liver enzymes AST and ALT, markers of liver damage that arise at the onset of olanzapine therapy. We have plan to publish the full results of this study next year. We’re currently conducting two double-blind placebo-controlled Phase 2 trials of miricorilant in patients with schizophrenia. The first, GRATITUDE. It is evaluating miricorilant in reversed, recent antipsychotic-induced weight gain. 100 patients will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of miricorilant or placebo for 12 weeks. GRATITUDE is being conducted at approximately 20 centers across the United States. During the third quarter, we initiated GRATITUDE 2, the randomized double-blind placebo-controlled Phase 2 trial of miricorilant to treat lungs and antipsychotic-induced weight gain. 150 patients with schizophrenia will continue to receive their established dose of antipsychotic medication plus either 600 milligrams or 900 milligrams of miricorilant or placebo for 26 weeks. The primary endpoints reduction in body weight. GRATITUDE 2 will be conducted at 35 centers in the United States. In animal model, miricorilant also prevents and reverses fatty liver and liver fibrosis, precursors of non-alcoholic steatohepatitis or NASH, serious liver disorder that affects millions of patients. Later this month, we plan to start a 120-patient, double-blind placebo-controlled Phase 2 trial of miricorilant in patients with NASH. Corcept’s third quarter results, we plan to declare the pandemic-related public health measures and related changes in physician and patient behavior. That being said, our commercial business is remarkably stable and is poised to resume its growth once the pandemic subsides. We expect to finish the year within the balance of our regional pre-pandemic revenue guidance to be now in the range of $355 million to $365 million. Our cash and investments grew by $34.7 million to $442.2 million. We announced a program to repurchase up to $200 million of our common stock. Our clinical program continues to broaden and will produce significant data in 2021 to 2022. Enrollment is underway in two Phase 3 trials of relacorilant, our planned [indiscernible] in Cushing’s syndrome. We expect the GRACE trial to provide basis for NDA submission in second quarter of 2022. Our second trial, GRADIENT, is evaluating relacorilant in patients with Cushing’s syndrome with adrenal enlarged. We’re confident we will help physicians better understand treatments [indiscernible] etiology of issues. Data from the first 40 patients in our Phase 2 RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer will be available in the first half of next year. Sufficiently positive results of RELIANT will likely qualified with relacorilant for accelerated approved. Our controlled, Phase 2 trial of relacorilant, plus nab-paclitaxel in patients with metastatic ovarian cancer will also produce results in the first half of 2021. Last month, we initiated a 20-patient, open-label, Phase I-b trial of relacorilant combined with PD-1 checkpoint inhibitor pembrolizumab to treat patients with advanced adrenal cancer and cortisol excess. Finally, in the first quarter of next year, we expect to select the optimum dose of exicorilant to advance in combination with enzalutamide in controlled Phase 2 trial in patients with castration-resistant prostate cancer. Our program in metabolic diseases also made significant gains. Enrollment and site activation continue with GRATITUDE, our double-blind placebo-controlled Phase 2 trial of miricorilant to reduce recent antipsychotic-induced weight gain. We have been developing enrollment in GRATITUDE 2, a double-blind, placebo-controlled Phase 2 trial miricorilant in patients with long-standing antipsychotic-induced weight gain. We expect to start a double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with NASH later this month. I’ll stop here for questions.

Thank you. [Operator Instructions] At this time, our first question will come from Tazeen Ahmad of Bank of America.

Good afternoon. Thanks for taking my questions. A couple for me. So, I guess if you guys end up winning the PGR, and let's say, also the district court case, and you do in that event have no competition for Korlym for several years. And you also plan on launching relacorilant in Cushing’s. How do you think that both of those drugs could co-exist? Is there a subset of the population that might be better served with one drug over the other? Or is it your view that over time, sales for Korlym would fade off as there's more pickup for relacorilant?

Thank you, Tazeen. This is Charlie. So, I'll answer the first part of the question and just talk about [Technical Difficulty] two drugs. But I just want to say, if we really think, this is true of having a patent that has only grown to relacorilant for 2037. So, it's 17 years of additional protection. So quite a long time, so we could pressure the one. I just want to make it clear to folks that if we have that kind of legal success, we will describe that is the one who has a problem after that. But as to that we’re [indiscernible].

Sure, Charlie. Thanks for the questions, Tazeen. It seems to be completely straightforward that Tazeen, I think that relacorilant is a clearly superior medication to Korlym, if it pans out the way it has so far. I think the main thing is prevention from any side effects and now we have find out drugs with these types of [indiscernible] it’s my expectation that over time relacorilant would entirely replace Korlym as the first-choice drug.

Okay. And can you think that would happen immediately or would that be more of a gradual switch over?

It’s a little hard to say, but my expectation is that it’d be sooner rather than later.

Okay, thank you. And then maybe one question, if I may on pipeline program for NASH, it seems like there are many mechanisms of action that are being explored by many different companies. And I was curious, it's very early. But how do you think your particular approach could be differentiated either in terms of efficacy and/or safety in that population? Thanks.

Tazeen, I’d like to just – I haven’t heard. Our Chief Medical Officer, Andreas Grauer, can you take that question.

Tazeen, thank you so much for the question. [Technical Difficulty]

I think just as I understand, it’s a good sort of [indiscernible]. We want to see the patients’ who are treated with Korlym that we can go and measure, not specifically NASH, but people who had one standard [Technical Difficulty] over a period of time. These enzymes often normalize and once that [indiscernible] on the path which we’re employing to the pre-clinical testing that Andreas was describing, and we’re really was employing to see what that translates [indiscernible].

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

I think we’re just getting started. We’re hoping to start screening and we’re hoping to start screening 2021 timeframe and we’re hoping to have data in 2021.

Okay. Great. Thank you for the questions.

And we’ll move to the next question from Matt Kaplan of Ladenburg Thalmann.

Hi. Good afternoon, guys, and thanks for taking the questions. Just a few questions with respect to maybe digging into the impact of the COVID-19 pandemic, the progress with the GRACE study and GRADIENT the next Phase 3 study as well. What are you seeing there in terms of challenges?

Yes. It’s a little bit choppy. So hoping you are asking the question in parts of our ongoing Korlym or GRACE study.

No, in terms of the ongoing GRACE study and GRADIENT studies, the impact of COVID-19 on those programs?

As far as the COVID pandemic it’s tough dealing with everybody, we are still working on [Technical Difficulty].

I’ll just remind, just for those who had missed it, at the beginning of the pandemic [indiscernible] we didn’t extend the timeline to the point where it is right now, probably we’ve not changed it since that time.

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

Yes. The 2037 data I mentioned is just a date of a kind of our longest running patent and [indiscernible] now PGR, that is as I mentioned have an important decision about in a couple of weeks. So that’s within 2037. And that’s sort of racketing, [Technical Difficulty]. So if they’re going to settle into something that they are getting into the generic company some amount of time for those longest running patents. But that’s just sort of the way the average, so we are feeling good about it right now. So I really bracket is, it’s not really taking off. I just I do have one in that’s 2037 and we’ll have to see if there is anything.

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

In the interim analysis that was running from the first half, we have basically – look at the first look at the [Technical Difficulty] we’re tracking more success and there is obviously given some [indiscernible] fast pace.

Sorry, go ahead please.

Yes. Just in terms of -- maybe you can help us understand what objective response rate would be deemed as successful. I guess pancreatic cancer is obviously a very difficult indication.

Yes, absolutely. And I just I believe little bit of context this is the trial [indiscernible] pancreatic cancer is really very bad to people and currently the response for most treatments that can be tried in these patients if they do it and improving very much. So, at any response would probably being improvement for this patient. And for accelerated approval at the FDA is a significant part. And the one what is it like to be bothered and that something different that isn’t subjective statement. And we feel that if we had a 20% response rate, everybody would like better, and less than that, but it’s better than trans-therapy distributor and we have to have a careful look at the data and see what comes there.

Okay. thank you very much and congrats on the progress.

And we’ll go to our next question from Roger Song of Jefferies.

Great. Great. Thank you. Good afternoon. Thank you for taking my question. Maybe the first one goes into the Cushing's syndrome franchise, because we see both up to potentially new steroidogenesis incubator both of them are guide like a 300 million to 400 million pixels for Cushing’s syndrome and the given colon already tracking this kind of a range. Then how would you kind of reconcile this to your expectations for your Cushing’s syndrome franchise?

I apologize, but really a breaking up and I got 50% of what we would say. Could you see [Technical Difficulty].

Can you hear me now?

Yes. Now, we can hear you.

Okay, great. Sorry. So, I just try to understand this, so we have two new steroidogenesis incubators, they are kind of a guiding 300 million to 400 million pixels for Cushing’s syndrome and given colon already attracting disarranged and how do you reconcile this to your expectation for the Cushing’s syndrome franchise for colon and the potential kind of colon.

Yes, Roger, this is Sean Maduck, Chief Commercial Officer. Just that you were asking [Technical Difficulty]? Is that what you were asking?

Yes, yes.

Yes. So specifically, I would say right now, there’s been minimal impact with the industry. That’s what bringing a couple of things to those on the call. This is the medication that has a mechanism of action is very similar to that, a low-price medication that is sometimes used off label to treat Cushing’s disease. And the important point here, as indicated 4% to be and not be broader Cushing’s syndrome spectrum [indiscernible] syndrome.

Okay, got it. Thank you. Okay, maybe next question for the Exicorilant, so we see that you are going to select the dosing next quarter – the first quarter of next year. I’m just curious what needs to be done to select those? And I believe the last quarter you were guided towards the end of this year. So, I just curious what the length quarter of those introduction?

We have from – we are starting with the next segment of our Phase 1/3 trial, which would lead us through the year to a very certain part of the colon. These kind of the trials in terms of taking longer than we were – trial is up and running and recruiting patients and we hope as a result of that can be able to do our ultimate mind people, the reaction of two parallel trials and one more from this and which is the Exicorilant trial that Sean mentioned and then collaboration with industry in Chicago. there is an investigator sponsored trial in other colon by similar patient population, prostate cancer patient and by the end of the first quarter, we look to get rid of both of these trials to be able to make a decision on what they want to do make over.

Got it, okay. That’s fair. Okay, great. Thank you. That’s all my questions. Thanks for the explanation.

Thanks, Roger.

Thank you, Roger.

And we’ll move to the next question from Swayampakula Ramakanth of H.C. Wainwright.

Thank you. And I just want to check and see if you guys can hear my voice clearly, because I’ve been having a very choppy evening.

Yes, we can hear you.

Yes, we can.

Okay. So, just trying to understand the third quarter, the revenue run and also trying to understand the guidance that you put out. So, based on your guidance; if I take the midpoint, you’re expecting approximately about 6% growth from the third quarter base. So, just trying to understand the confidence for that number and is there a possibility to do closer to your previous guidance and at the upper end of the previous guidance?

Before you start, I didn’t get a chance to introduce Sean. Sean Maduck is our Chief Commercial Officer and let him answer that question.

Yes. Thanks for the question. I’m going to answer in three parts. First, I want to talk about what happened over the pandemic and then we’ll talk a little bit about the expectations for Q4. So, there are two key drivers for our revenue, the two key components, one is patient retention, and then the second is unique patient acquisition. during this COVID window is doing well, our inpatients, but apparently, new patients have been challenging. And Joe talked about this during his remarks. So, there’s three key factors that have impacted us over the last six months and the first – it varies state by state, but physicians have moved to more of a hybrid model of in-person in telemedicine and they’re not seeing patients with the same frequency that they have previously in pre-pandemic. So, screening the diagnosis rates are down, which, of course, impacts the patient’s ability to get diagnosed and then get treated and then to get to an optimal treatment regimen, that’s point one. Point two; even if patients are able to go to the physicians or to give their labs, they’ve been very reluctant to do so. Those are very, very sick patients. And due to the preexisting conditions until the virus that they haven’t been doing. and the third piece is, the whole practices in health systems have been open to some patients and many have been closed to the pharmaceutical industry, which impacts our clinical ability to educate new potential prescribers. So, as Joe mentioned, we needed a technology platform and we're doing what we can to try new things, to reach physicians when in-person interaction is not feasible. So, in terms of Q4, it takes time for a patient to be diagnosed. It takes time for a patient to potentially to be fully on for Korlym, and then it takes time for them to verify the authenticate and reopen its business impact. So, there's a lag on that first few months. And we already mentioned that is definitely a significant slowdown in physician interaction in Q2, when everything was shutdown with the onset of COVID-19, and that slowdown impacted Q3. Now, the changes I think have somewhat in the third quarter, there are revenue in activity and a nice factor that will benefit our Q4.

Okay. Thank you for that. The next question is on the pancreatic cancer trial. I understand from your initial comments that you have the data from first 40 patients in the fourth quarter of 2021. Could you give us an idea of when we could complete the study? And the data from the study is positive? Is that enough to file for an approval or do you need to do another study?

I think you said first trial.

I meant first quarter of 2021.

And after that, and I think you said first half of 2021 for excluding that we have to be on that study. And again, that's an interim analysis of 40 patients currently that the current trial requires listing more 80 patients so with [indiscernible] syndrome, obviously it depends on the speed of enrolment that we would have and what we currently have from the data, [indiscernible] overall trial nine to 12 months later.

And then to answer your second question, yes, we need the sufficient results in that study will be the one that we would set for in the NDA. So, cross the fingers, so obviously results pending, that this is a very [indiscernible] to help them. In the end it’s pretty [indiscernible] to see if got the acceptable results.

Okay. Thank you, gentlemen. Thanks for taking the questions.

And we’ll go to Alan Leong of BioWatch News.

Hi Jo. Hi, Charlie. Good evening to Andreas and Sean. I appreciate that it’s on Election Day. So, I won’t ask you if you voted and who for?

Yes. Yes.

Let me ask you, first over something, over the GRATITUDE trial, and you briefly talked about this, I think, about six months ago, but which GRATITUDE trial has a more difficult enrollment proposition among investigators? And if so, when you comment can you compare the trial enrollment execution of the two of GRATITUDE I versus GRATITUDE II? And let me put it – slip in a second question. It's so hard to do that. What is the endpoint goal for GRATITUDE I because I remember the healthy normal trials that you were just looking for a trend rather than statistical significance. I want to set expectations. You have a low dose with the old formulation, and now you've got a little bit of a bar because you're dealing with obese patients. So, yes.

Yes. Thank you for the question. So, first of all, the GRATITUDE I trial, we are enrolling patients with recent weight gain versus GRATITUDE II trial, which have been already I mentioned longtime making – we recently came in with somewhat harder to document and then so that trial is something very difficult to enroll. We started earlier than we think we would probably get the results of both trials about the same time on Q2 2022. And that trial is powered to detect a 5% reduction in weight. And then again, more uninterruptedly on this program, if you compare it to the healthy volunteer trials, keep in mind that healthy volunteers anyway chose these trials. So, the extent of infection is really affected by the duration of treatment of that.

Andreas, the one thing I’ll add to that Alan is – just to your point, it could be really looking into Phase 1 trial with healthy volunteered to see if the medication was actually very active in animals, and in the first had shown physically significant results also healthy volunteer study get similar character to these treatments. So, we are really very pleasantly surprised to see that we get specifically to benefit [indiscernible] as well. Now all that said, Andreas described this study is really different. Send patients to weight reduction as opposed to prevention of weight gain. So, we're optimistic because we take this drug is really very [Technical Difficulty] actually test that hypothesis in patients on weight reduction.

We have two trials that are really quite a contrast for a number of reasons. Let me ask you about the adrenal cancer trial. And it's really – this is a really thousand-foot view question. I was pleasantly surprised to go into Europe, United States and Israel and trials global. How does that dovetail with how you envision your eventual Cushing’s program of expansion?

Alan, I am not really sure I follow your questions. I think – but you actually on the given one, you are actually giving me an opportunity to present an important point that you may remember which you thought contact for a long time, but others may not. It is that quality improve with all nuance of Cushing's syndrome, including patients with adrenal cancer. Now what we noted in patients with adrenal cancer is that it really is very meaningful in improving their Cushing's syndrome. But as far as we could tell, really did not do anything in particular, neither better nor worse than the cancer over the quality of life actually really improved. The studies that we're dealing with [indiscernible] we are actually excluding patients with adrenal cancer. And so, we're not something that we lose there, and we faced that with the same reason, the reason we’ve got here is we think you can really offer clinical benefit in Cushing's syndrome for patients who had adrenal cancer. The really interesting thing about it is, that I talk about in my opening remarks is whether – person from an observation, the observation was given therapy, which is fantastic in lots of other cancers, did not seem to really work at all Cushing's syndrome or adrenal cancers [indiscernible] think about half of patients, who have adrenal tumors. And so, we are going to see in addition to benefit we think we can provide in Cushing's syndrome, which is really meaningful benefit. Can we also provide benefit in terms of tumor reduction and oncologic situation? We were exciting trial investigators are very excited to try that. And it seems like a very logical place for us to start because we thought it would at least be early to provide a benefit of some kind to these patients. Where we’ll need that? I don't know, but we’re very excited to see an excellent combination of immunotherapy and [indiscernible] modulation.

And one last question, I have to ask this. You have CORT113176 in Phase 1 and the trial of my understand is completed, how was that – do you finally take it forward at this point or – where if at all will the results be presented?

All right. So, first on, Alan, that the guy who knows more about those up than some of the great people, of course, I think it's very important steps. It is still a very early-stage compound, it's just in Phase 1 at this point in time. But we are really – a lot of that were covering academics here and we collaborate with active academics that I also point out animal models related to neuro systems diseases like ALS, Alzheimer's disease and alcohol use disorder showed very positive result, overall positive [indiscernible] and so forth. So, this is a very interesting compound for us, particularly interested in its effect in the last – it’s not only did we see in an animal model, and the prevention is the chronic disease, we actually saw [Technical Difficulty]. Now on the cost side, ALS is a terrible disease, tumor improved treatment is too much, and it would be wonderful to be able to provide treatment for these particular patients – therapeutics for these patients. And the other side is sadly the trail in ALS approved [Technical Difficulty]. So, it's hard to see what to do. Now, you're a little bit ahead of us with adjusted [Technical Difficulty] and probably the time that the next time we'll be able to give an answer to that question.

Thank you. I appreciate it.

All right. It looks like we had fun, hopefully in a productive way. Thank you very much for all filling in, and we will talk to you on fourth quarter. Thanks very much. Bye-bye.

This does conclude the call; we would like to thank everyone for your participation. You may now disconnect.