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spk05: and welcome to the Corset Therapeutics conference call. Today's call is being recorded. To signal for questions today, please press star 1. And at this time, I'd like to turn the call over to Charlie Robb. Please go ahead.
spk08: Thank you. Good afternoon, everyone. I'm Corset's Chief Financial Officer. Today, we issued a press release announcing our financial results for the third quarter and providing a corporate update. The copy is available at corset.com. Complete results will be available when we file our Form 10-Q in the SEC. Today's call is being recorded. A replay will be available November 17, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 International. Passcode will be 680-0706. Statements during this call, other than statements of historical fact, are core legitimacy 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 express or imply. These risks and uncertainties include and 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 CCD Frequencies, including generic versions of Corlum, the initiation or actual utilization, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Corlum, and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight, and other requirements. And the impact of the COVID-19 pandemic on our employees, consultants, and vendors, as well as on physicians, patients, insurers, regulators, and the practice of medicine generally. These and other risks are set forth in our FTC files, which are available at our website and the FTC's website. On this call, four of the key statements include those concerning our revenue guidance, cash flow and expected growth, our stock repurchase program, and its intended funding sources. 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 brought our control, physician awareness of hypercortisolism and the collection of coralline with the outcome of medical treatment, the timing, cost, and outcome of litigation, including our lawsuits against Teva Pharmaceuticals and Sun Pharmaceuticals, and some of the challenges of the validity of one of our patents, which was a patent trial in a field board, scope and protective power of our intellectual property, The benefits of work and drug designation, the progress in enrollment timing, design, and results of our clinical trials, and the clinical and commercial attributes of our coralline, hexacoralline, neurocoralline, and our other selected cortisol modulators. We disclaim any intention or duty to update or update. Revenue for the third quarter was $86.3 million, a 6% increase from the third quarter of 2019. Third quarter gap 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 utilization of deferred tax assets, together with related income tax effects, non-gap 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 in the 30th an increase of $34.7 million from June 3. All in consideration of our strong financial position and prospects, our Board of Directors has approved a program running from 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 conditions, our stock price, and other factors. We believe revenue from our Christian 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, we will update.
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spk08: In March 2018, we sued Temple Pharmaceuticals and Federal District Court to stop it from marketing a generic version of Coraline in violation of our patents. Our lawsuit stayed final FDA approval of Temple's proposed product for 30 months, a period which ended on August 1st. Discovery is underway. Originally, trial was set to begin February 2nd, 2021. Last month, the court vacated that date and ordered parties to complete trial preparations by March 17th, 2021. A new trial date has not been set. It could take place any time after March 17th. Kevin has also challenged the validity of one of our patents, the 214 patent, in a proceeding known as a Post-Grant Review, or PGR, before the U.S. Patent Office's Patent Trial and Appeals Board, or PDAB. As many of you know, oral argument in this matter was heard on September 2nd. We expect the PDAB to produce its decision on or about November 19th. The losing party may appeal to the Federal Circuit Court of Appeal. during which time the patent will remain in use. It's important to note that Teva is barred from challenging the validity of the 214 patent, and the district court case using arguments it raised or could have raised in the PGR. While Teva's attorney will undoubtedly try to do so anyway, the rules are intended to prevent Teva from getting a second bite at that apple. In any event, it is to the federal court that we will take about 12 to 16 months to resolve. Such an appeal takes place as soon as we expect definitive resolution of PGR in the fourth quarter of 2021. Home Pharmaceuticals is also seeking to market generic coral. Our lawsuit against Sun to see final FDA approval of Sun's proposed product, so the earlier December 8th, 2021, that is December 8th of next year, or a decision by the district court that the patents we have asserted against Sun are invalid, unenforceable, or not to French. Our dispute with Dunn is separate from our litigation against Teva, and it's following its own timeline. The Markman hearing and the Sun case were set for November of this year. The set date has been vacated, and a new date has not been considered. In addition, no trial date has been set. Predicting the timing of any district court litigation is difficult, and the possibility of delays 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, we will be ready. We look forward to putting our case before the judge. I will now turn the call over to Dr. Bruce Bellenau, our Chief Executive Officer. Charlie? Thank you, Charlie. The challenge posed by the COVID-19 pandemic underscores just how fortunate Corset is to have built a stable commercial business, profitable enough to fund an increasingly broad and advanced clinical development program. There are currently testing models used in our portfolio of proprietary selective cortisol modulators in two Phase III Cushion Syndrome trials, one Phase III, one Phase II, and two Phase IB oncology trials, and two, soon to be three, Phase II trials in metabolic disorders. These trials will generate important data next year and in 2022, even as additional novel models get into development. I know of no other company our size that combines commercial success with such diverse and promising clinical activities. I hardly need to tell you that these are difficult times for everyone. The COVID-19 pandemic has caused many individuals, including physicians and patients, to protect themselves from infection, most commonly by limiting their exposure to other people. Patients are reluctant to leave their homes, even to see their physician. Many medical practices have barred roughly limited in-person visits by commercial representatives. This reduction in face-to-face interactions makes every aspect of medical care more difficult, especially for accounts of serious conditions such as Cushing's syndrome. We are doing what we can to help. Our commercial team is divided into 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 being more receptive to the face-to-face type of care. Diagnosing and treating patients with cooking syndrome requires more preventative work and more actions to treat patients and physicians. Nonetheless, patients who are using Corolla before the pandemic are highly motivated to continue to use it. Despite the current pandemic-caused obstacles, we're continuing to enroll new patients and add to our roster of Corolla prescribers, albeit at a needed pace, for one reason. Coraline is an effective treatment that has greatly improved the lives of many patients with Cushing Syndrome, a life-threatening chronic illness. Pandemic-related changes in medical practice and patient behavior modestly reduced our revenues this quarter, but the foundation of our business, an effective medication promoted by a dedicated commercial team that puts the interests of patients first, remains rock solid and fluid to support significant growth once conditions As I said on prior calls, there are many patients who could benefit from Coraline who have not yet received it. Our planned successor to Coraline, Rella Coraline, has the potential to benefit many more. The stock repurchase program we announced today reflects our board's confidence in the fundamental strength of our business. The most important use of our cash is to fully fund our commercial operations and our increasingly broad clinical development program. With those needs met, our stock repurchase program allows us to purchase our stock when we think it is undervalued, like we think it is now. As many of you know, we are evaluating Rela Coraline, our plant's accessory to Coraline, for patients with Fishing Syndrome, in two Phase III trials. Rela Coraline is a selective cortisol modulator. Rela Coraline can achieve this effect by contributing with cortisol to the group of cortisol receptors, DR for short. Oline Chlorine does not bind to the progesterone receptor, GEL, which means it does not cause off-target deaths, including termination of pregnancy, endometrial fizzling, natural bleeding caused by activity of downed cell. By a different mechanism, REL Chlorine also does not appear to cause hypokinemia, low potassium, a serious side effect experienced by 44% of patients in Chlorine's clinical trial. Chlorine-induced hypokalemia is a leading cause of chlorine discontinuation. Relic-chlorine's Phase II clinical data was clearly positive. Agents experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs of symptoms of pressure syndrome. There were no relic-chlorine-induced instances of industrial thickening, vaginal bleeding, and also no drug-induced hypokalemia. Our pleasure in presenting these results can be found at the Investors slash Past Events tab of our website. We expect Relacorlin's Phase III RAGE trial to serve as the basis for our NDA submission from Cushing's Syndrome. RAGE continues to enroll patients with any etiology of Cushing's Syndrome, although it was being stated before the pandemic has slowed its pace. We expect to submit our NDA in the second quarter of Last quarter, we did the first patient in Relafrolin's second base 3 trial of patients with Cushing syndrome, the Gradient trial. Gradient is specifically studying Relafrolin's effects in patients whose Cushing syndrome is caused by adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but ultimately their health outcomes are poor. Gradient is the first controlled study in patients with this type of Cushing syndrome. The expected findings will contribute to the optimal treatment of these patients. Participants in gradient will receive either relucoralin or placebo for 22 weeks. The primary endpoints are statistically significant improvements to hypertension or glucose metabolism. All of the other common manifestations of Christian 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 GRACIES. You can find our poster presentation GRACIES Design at the Research and Pipeline slash Publications tab on our website. Our oncology program originated in theories postulated by investigators at the University of Chicago more than 10 years ago. It now consists of four clinical trials, two of which will produce data for the first half of next year. Our program is examining each of the three mechanisms by which cortisol modulation may help treat patients with solid tumors. Cortisol suppresses apoptosis, a program so that chemotherapy is intended to induce. There is compelling preclinical and clinical data suggesting that reliquary can help chemotherapy reach its full potential by blunting cortisol and the apoptotic effect. We are testing this hypothesis in patients with metastatic ovarian cancer and metastatic pancreatic cancer. We initiated these trials following encouraging results in our Phase 1-2 trial of reliquorolin combined with MAP-Hapipaxil, a cell genie drug, a braxane. Tumors in 7 to 25 patients with metastatic pancreatic cancer and in 5 of 11 patients with platinum-resistant ovarian cancer either shrank or stopped growing for 16 weeks or longer. Two patients with metastatic pancreatic cancer exhibited tumor shrinkage for 65 weeks. All patients had experienced disease progression during multiple prior lines of chemotherapy, including treatment with taxis. We presented these results at ASCO in 2019. You can find our poster at the Research and Pipeline slash Public Patient page on our website. In August, we began enrolling patients in Reliance, Each patient will be labeled Phase III trial relucoriline plus NAP-haclitaxel in patients with metastatic pancreatic cancer. Each patient will receive relucoriline plus NAP-haclitaxel. The primary endpoint is objective response rate, and secondary endpoints including progression-free survival and duration of response. We expect to conduct an analysis of results in Reliance's first 40 patients in the first half of 2020. The expected response rate to MAP-Aquataxel monotherapy in patients with metastatic pancreatic cancer is zero. We believe it's a visually positive result and reliant to support accelerated approval. In July, we completed enrollment in our controlled phase two trial in patients with cancer severity cancer. 178 patients were randomized to receive nabpaclopaxil and either continuous dosing of reliquaryland, intermittent dosing of reliquaryland, or placebo. The primary endpoint is progression-free survival, and secondary endpoints including objective response rate and duration of response. We expect results from the study in the first half of next year. Cortisol activation reduces inflammation and suppresses the immune system. which is why synthetic cortisols are used to treat autoimmune and inflammatory disorders such as rheumatoid arthritis, time-throwing valve disease, and multiple sclerosis. Unfortunately, by suppressing the immune system, cortisol also diminishes the effectiveness of immunotherapy in treating patients with solid tumors. In September, we initiated an open-label, Phase 1 retrial of Relicoralin Plus, the PD-1 checkpoint inhibitor, Pembrolizumab, works for Keytruda in patients with advanced adrenal cancer whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and Cushing's syndrome, a very bad combination. We believe that cortisol excess may also interact and counteract the intended effect of Pembrolizumab, which is rarely effective as monotherapy Our trial is evaluating whether relafloralin can treat these patients' Christian syndrome by reducing the effects of excess cortisol activity and by reversing cortisol-induced immune suppression, also allowing hyperlipidemia 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 researchandpipeline.com. 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 and duration of response. Investigators at the University of Chicago have shown that cortisol stimulates tumor growth in patients with castration-resistant prostate cancer. a finding that was confirmed by researchers at Memorial Sloan Kettering Cancer Center. This org explains why patients treated with a widely prescribed androgen receptor antagonist and thalidomide eventually experienced reduced tumor growth. Deprived of androgen stimulation, the tumors often utilized cortisol as a growth pathway. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape We are conducting a phase 1b trial of our selected cortisol modulator, Epsichloroquine, combined with enzaluminide in patients with castration-resistant prostate cancer and expect to identify the dose range suitable for advancing to a larger control study in the first quarter of 2021. I will conclude with an update of our program in metabolic diseases. In the United States, 6 million people take antipsychotic medications such as Lanzapine, the liability drug Zyprexa, and Risperidone, J&J's Risperdal, treat illnesses such as schizophrenia, bipolar disorder, and major depression. While these drugs are very effective, the exact steep price can form a rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances. Patients can gain within 50 pounds, and the life expectancy is decreased on average by 20 years, due in part to excess cardiovascular event such as heart attacks and strokes. We have completed three double-blind placebo-controlled clinical trials in healthy subjects in which co-administration of a cortisol modulator reduced these dangerous metabolic adverse effects. Two of these trials used nifepristone, the acting ingredient in Quorla. Our positive results were published in the journals Advanced Therapy and Obesity, 2009 and 2010. Unfortunately, Quorla, which shares its active ingredient with the abortion pill, cannot be advanced for such a prevalent disorder. Miracorlin, by contrast, is not the abortion pill and can be advanced for this use. Last quarter, we considered a trial in which healthy subjects received olanzapine and either 600 milligrams of Miracorlin, 900 milligrams of Miracorlin, or placebo for 14 days. Study participants who received Miracorlin gained significantly less weight than those who received placebo. In addition, they exhibited a smaller increase in triglycerides and the liver enzymes AST and ALT, markers of liver damage that rise to the onset or last with therapy. We can't plan to publish the full results of this study next year. We are currently conducting two double-blind placebo-controlled phase two trials of Neurochloralyn to patients with schizophrenia. The first, Gratitude, is evaluating whether Neurochloralyn can reverse research 100 patients were received, in addition to their established dose of antipsychotic medication, and 600 milligrams of neurochloroquine for placebo for 12 weeks. Gratitudes being conducted are approximately 20 centers across the United States. During the third quarter, we initiated Gratitude II, a randomized double-blind placebo-controlled Phase II trial of neurochloroquine to treat long-standing antipsychotic abuse. 150 patients with schizophrenia will continue to receive their established dose of antipsychotic medication plus either 600 milligrams or 900 milligrams of miracoralin for a placebo for 26 weeks. The primary endpoint is reduction in body weight. Gratitude 2 will be conducted at 35 centers in the United States. In animal models, miracoralin also prevents and reverses fatty liver and liver fibrosis. precursors of non-alcoholic steatohepatitis, or NASH, a serious liver disorder that affects millions of patients. Later this month, we plan to start a 120-patient, double-blind, placebo-controlled Phase II trial of neurochloroquine to patients with NASH. Four steps for the results would one be because of 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 bounds of our original pre-pandemic revenue guidance, which we now have to arrange at $355 to $365 million. Our cash and investments move by $34.7 million to $442.2 million. We announced a preliminary purchase of $200 million of our common stock. Our clinical program continues to broaden and will produce significant data to 2021 and 2022. Enrollment is underway in two phase three trials of relic correlates, our plans, et cetera, in Cushing syndrome. We expect the GRACE trial to provide basis for NDA submissions in the second quarter of 2022. Our second trial, GRADIANCE, is evaluating relic correlates in patients with Cushing syndrome of adrenal large. We are confident it will help physicians better understand and treat this less-studied physiology of the disease. Data from the first 40 patients in our phase 3 reliant trial for relic oralin for SNAP-Aquitaxel in patients with metastatic pancreatic cancer will be available in the first half of next year. Sufficiently positive results from the reliant will likely qualify relic oralin for accelerated approval. Our controlled Phase 2 trial of relacoralin plus napadlipaxil in patients with metastatic ovarian cancer will also produce results in the first half of 2021. Last month, we initiated the 20-page in-field label Phase 1B trial of relacoralin combined with a PD-1 checkpoint inhibitor and relizumab 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 hexachloroquine to advance in combination with enzalutamide in controlled phase II trial patients with castration-resistant prostate cancer. Our program in metabolic disease is also based in metabolic disease. Enrollment in site activation and continued gratitude are double-blind placebo-controlled phase II trial of merachloroquine to reduce recent antipsychotic reduced risk. And we have begun enrollment in gratitude II double-blind placebo-controlled Phase II trial of Miracoron for patients with long-standing antipsychotics. We expect to start a double-blind placebo-controlled Phase II trial of Miracoron for patients with NASH later this month.
spk01: I'll stop here for questions.
spk05: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. And if you're on speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment. Again, that is star one for questions. We'll pause just a moment so that everyone has an opportunity to signal for questions. And we will go to our first question from, at this time, our first question will come from Hazeen Ahmad of Bank of America.
spk04: Hi. Good afternoon. Thanks for taking my questions. A couple for me. So I guess, Joe, if you guys end up winning the PTR and let's say also the district court case and you do in that event have no competition for Coraline for several years and you also plan on launching Relacoraline in Cushing, how do you think that both of those drugs could coexist? Is there a subset of the population that might be that are served with one drug over the other? Or is it your view that over time sales for Coraline would fade as there's more pickup for Coraline?
spk08: Hey, Suzanne. Thanks. This is Charlie. So I'll answer the first part of the question. We may want to just talk about the relative use of the two drugs. But I just want to say, if we win the district court case, it's true, we'll have a, you know, Patent that has protected koalas and kept koalas through 2037. So it's 17 years of additional protection. So quite a long time, which makes your question a very pertinent one. But I just wanted to make it clear to folks that if you have that kind of legal success you've described, that is the money you have with koalas after that. But as to the role of those koalas and koalas, Dave, you want to address that? Sure, Charlie. Thanks for the question, Satine. Just to be completely straightforward about it, I think that Relaforam is a purely superior medication to Quora. I think it pans out the way it has so far. I think removing its progesterone-related side effects, and now as we find out, a drug-abuse type of bulimia. It's my expectation that over time, Relaforam will entirely replace Quora as the first choice drug.
spk04: Okay. And do you think that would happen immediately, or would that be more of a gradual switch over?
spk08: Yeah, I could do a large save, of course. But my expectation is that it would be sooner rather than later.
spk04: OK, thank you. And then maybe one question, if I may, on a pipeline program for NASH. It seems that 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.
spk08: I'd like to just, because I have him here, our Chief Medical Officer, Andreas Grauer, and I think he'll take your questions. Again, thanks so much for the question. It's a great one, and we should be at the end of it already. We've seen very promising data in this particular disease model and this kind of a model.
spk07: The first thing I want to say is the mechanism is totally different from how the other drugs that are in development are addressing SMASH.
spk08: That's why we're doing these concepts right now as a first step. And the JT profile will obviously also in the future work great. I think just as I said, just sort of how we got here. You know, we've noticed with patients who were treated with Corolla, that in at least one measure, not specifically NASH, but people who had long-standing elevations in their implants with an irritation over a period of time, their enzymes often normalized. And that's what really started us on the path with their Corolla to the preclinical testing that Andreas has described. We're really looking forward to see if that translates to gene effects. So we'll talk to you in the future about it.
spk04: Okay. And do you have a sense of when we would be able to see data from that program?
spk08: We're just getting started. We're hoping to start screening, like, imminently, basically. And we're hoping to have data in about 18 months.
spk06: Okay. Great. Thank you for the question. And we'll move to a question from Matt Kaplan of Ladinburg-Fallman.
spk08: Hi. Good afternoon, guys, and thanks for taking the question. Just a few questions with respect to maybe digging into the impact of the COVID-19 pandemic, the progress with the GRACE studies and the gradient study as well. What are you seeing there in terms of challenges? Matt, it's a little bit choppy to hear you, so were you asking the question in part to an ongoing business requirement or the GRADE study? No, in terms of the ongoing GRADE study and gradient studies, the impact of COVID-19 on those programs. Andreas, please. Well, I mean, the COVID pandemic is tough to deal with for everybody.
spk07: We are still working on meeting our in his remarks and are working on filing on futures.
spk08: I just remind you, just for those of you who haven't heard, that at the beginning of the pandemic, and we really didn't notice what was in fact going on at that point too, we did extend the timeline to the point where it is right now, but we have not changed it since that point in time. Okay. That's helpful. Thanks. And then in terms of, I guess, maybe a question for Charlie, you kind of portrayed kind of a best case scenario of 2037 for if everything goes in your direction with the litigation with Kevin's son. Can you help bracket that and help us understand in terms of maybe a base case scenario in terms of how things could progress in the other end of that spectrum when you could potentially see a generic competition the way things are playing out right now? Well, the 2037 date I mentioned is just the date of kind of our longest running patent and the one also that's being challenged now for PGR that we will, as I mentioned, have an important decision about in a couple of weeks. So that's what the 2037 date runs to. And as for sort of bracketing, I think that's really kind of hard to do. we have a patent that runs through 2037. There's no bracketing effect, that's just the date. Typically, these cases settle if they are going to settle, and I'm talking about last year, by giving the generic company some amount of time, both years and that long in front of the patent. But that's just sort of the way the averages work. It doesn't necessarily mean the same amount of time here. We're feeling very good about our piece right now. We'll see what happens. But really, a bracket is not really an anchor offer. I do have one end of it that's 2037, and we'll have to see if there's any other data there. Okay. Okay. That's helpful. Thanks. And then just in terms of a pipeline question, if I may, the Reliance 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 21. 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? The in-ring analysis that we're planning from this first half is basically give us a first look at the front end. At that point, not power to make any definitive conclusions, but it is a limitation on where we are and whether we're tracking towards success. And it will obviously give us a how it will work for you. It was an encouragement to continue the trial lab at the end of the first phase. And we'll just add, sorry, go ahead, please. Yeah, just in terms of maybe you can help us understand what objective response rate would be deemed as successful. You know, I guess pancreatic cancer is, you know, obviously a very difficult indication. Yeah, absolutely. And I just want to add a little bit of context, right? This is a trial in patients with 39 or more
spk07: of pancreatic cancer. So they're really very, very cheap people. And currently, the response for most treatments that can be tried in these patients is zero. So any response would probably be improving for these patients.
spk08: The bar for accelerated approval at the FDA is a significant bar. In their own words, they like to be loud about the results, and that's obviously somewhat of a subjective statement. I mean, we feel if we had a 20% response rate, everybody would be loud by that. And it is less than that, but it still better than what current therapies deliver, then we'll have to have a careful look at the data and see what comes out.
spk01: Okay. Thank you very much and congrats on the progress.
spk06: And we'll go to our next question from Roger Song of Jefferies. Great. Great. Thank you. Good afternoon.
spk08: Thank you for taking my question. Maybe the first one goes into the Cushing syndrome franchise. We see both of two potential new stereogenesis inhibitor. Both of them die like 300 to 400 million peak cells for Cushing syndrome. And given Colin already tracking this kind of a range, and how would you kind of reconcile this to your expectations for your questions in your franchise? I apologize, but really if you were breaking up and I caught probably 50% of what you were saying, could you please repeat it?
spk01: I'm sorry to make you do that, but I want to make sure that we answer the questions you want answered. Now we're getting 0% of what you're seeing in here.
spk06: We can't hear you.
spk01: Can you hear me now? Yes. Yeah, now we can. Okay, great. Sorry.
spk08: I just tried to understand this. So we have two new steroid genesis inhibitor. They are guiding 300 to 400 million peak sales for Christian syndrome. And given Colin already tracking this range, and how do you reconcile this to your expectation for the Christian syndrome franchise for Colin and the potential . Yeah, yep. Yeah, so specifically I would say right now there's been minimal impact with the approval of Hysteriza. I just want to point out a couple of quick things for those on the call. Hysteriza is a medication that has a mechanism of action that's very similar to a low-price medication, Vitarapone, that is sometimes used off-label to treat such disease. The other important point here is that Hysteriza is indicated for Christian syndrome spectrum or all the ideologies of the syndrome. Okay, got it. Thank you. Okay, maybe next question for the ex-correlant. So we see that you're going to select the dosing next quarter, the first quarter next year. I'm just curious what needs to be done to select the dose. And I believe the last quarter you guided it towards the end of this year. So I'm just curious what delays for the dosing selection. We started the next segment of our phase 1 slash 2 trial, which will lead us to a dose for hexacorbin. We started the trial in the times of COVID.
spk07: It's taken a little longer than we were hoping it would. But the trial's up and running and recruiting patients. And we hope as a result of that, we will be able to make a decision.
spk08: I also want to remind people that we actually have two parallel trials ongoing. One that we're running ourselves, which is the XFR1 trial that you just mentioned. And then in collaboration with the University of Chicago, there is an investigator-sponsored trial we've had a call on.
spk07: very similar patient population of prostate cancer patients. And by the end of first quarter, we hope to have results for both of those trials to be able to make a decision on what we want to move forward.
spk06: Got it. OK, that's fair. OK, great. Thank you. That's all my questions. Sorry for the connection.
spk01: Thank you, Rod. Thank you, Rod.
spk05: And we'll move to our next question from Ramakant of HC Wainwright.
spk08: Thank you. I just want to check and see if you guys can hear my voice clearly because I've been having a very choppy evening.
spk02: Yes, we can hear you. Okay.
spk08: So just trying to understand the third quarter, you know, 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 a 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 your previous guidance. Before you start, I think we have a chance to introduce Sean, Sean DeDuke, Chief Commercial Officer, and let him answer that question. Yeah, thanks for the question. I'm going to answer it in two parts. I first want to talk about what's happened over the pandemic and then talk a little bit about expectations for Q4. There are two key drivers to our revenue, two key components. One is patient retention and then the second is new patient acquisition. During this COVID window we've done well retaining patients, but acquiring new patients has been challenging and Joe talked about this during the opening remarks. So there's three key factors I think that have impacted us over the last six months and the first It varies state by state, but physicians have moved to a more of a hybrid model of in person and telemedicine appointments and they're not seeing patients with the same frequency that they have previously in pre-pandemic. So screening and diagnosis rates are down, which of course impacts the patient's ability to get diagnosed, to then get treated, and then to get to an optimal treatment regimen. So that's point one. Point two, even if patients are able to go see their physicians or to go get labs, they've been very reluctant to do so. These are very, very sick patients, and due to pre-existing conditions and the virus, they haven't been born. And the third piece is that although practices and health systems have been open to seeing patients, many have been closed to the pharmaceutical industry, which impacts our clinical flexibility to educate new potential prescribers. So as Joe mentioned, we've moved to virtual technology platforms and we're doing what we can and trying new things to reach physicians when in person interaction is not feasible. So in terms of Q4, you know, it takes time for a patient to be diagnosed. It takes time for a patient to potentially be full on correlates and then it takes time for them to get to an optimal growth where we ultimately see a business impact. So there's a lag on that a few months. And I already mentioned there was definitely a significant slowdown of physician interaction in Q2 when everything sort of shut down with the onset of COVID-19. And that slowdown impacted Q3. Now, the changes, I think, have opened up somewhat in the third quarter. There was an increase in activity, and I expect that that will benefit
spk06: Thank you for that.
spk08: 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 first quarter of 21. Could you give us an idea of when you could complete this study and the data from this study is positive, is that enough to file for an approval or do you need to do another study? I think you said first half.
spk06: I meant for quarter 21.
spk08: Yeah, but I think we said first half of 2021 for when we will have the data on that study. And again, there's some interim analysis of 40 patients who currently have the current trial design. It requires additional aviation, so it would be a doubling of that size, and then obviously it depends on the speed of enrollment that we would have.
spk07: But what we currently think is that we should have the data and for the overall trial about nine to 12 months later.
spk08: In answer to your second question, R.K., yes, we think that with sufficient results, that study would be the one the FDA would accept for an NDA. So, cross our fingers, it's obviously result-dependent, but this is, you know, very ill-gifted patients. There's really not much else to help them. And the FDA is pretty interested, but it's on us to see if our drug produces the acceptable results.
spk01: Okay. Thank you, gentlemen. Thanks for taking the questions.
spk06: And we'll go to El and Leon of Firewatch News. Hi, Joe.
spk08: Hi, Charlie and Dede, Andrew, and Sean. I appreciate that it's on election day, so I want to ask you if you voted and who for. Yes.
spk02: Yes. Yes.
spk08: Let me ask you, actually, you know, I'll first go over something, over the gratitude trials. And you briefly talked about this about, 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 that, compare the trial enrollment execution of the two, gratitude one versus gratitude two? And let me put it, slip in a second question. Sorry to do that. What's the endpoint goal for gratitude one? Because I remember the healthy normal trial 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. Yeah, thank you for the question. So first of all, the Gratitude 1 trial is involving patients with recent weight gain versus the Gratitude 2 trial, which has been involving patients with long-term weight gain. And the recent weight gain in those ways is somewhat harder to document, and so that trial is more difficult to involve.
spk07: We started it earlier, so we think we will probably get the results of both trials at the same time, around Q2 2022.
spk08: And the trial is powered to detect a 5% rate. 5% reduction in weight. And again, what I was able to do earlier is tell them, but if you compare it to the healthy volunteer trials, you have to keep in mind that healthy volunteers, these were two-week trials.
spk07: This is a three-month trial. So the extent of the effect will obviously be affected by the duration of treatment.
spk08: That's exactly right. The only thing I'd add to that, Alan, is just to your point, We were really looking in the phase one trial in Healthy Volunteers to see if the medication was active. It was a very active animal, and the CapriStone had shown significantly significant results also in the Healthy Volunteers study, similar character, two weeks of treatment. And we were just really very pleasantly surprised to see that we got significantly significant results with Miracor as well. Now all that said, Andreas has described to you a study that's really different. It's in patients. It's about weight reduction as opposed to prevention of weight gain. So we're optimistic because we think this drug is really very close to what we think that it is. But these are the first two studies that we're willing to actually test that hypothesis in patients on weight reduction.
spk06: Yeah, the two trials are really quite a contrast for a number of reasons.
spk08: Let me ask you about the adrenal cancer trial. And it's really, this is really a thousand-foot view question. You know, I was pleasantly surprised you're going to Europe, United States, and Israel to trial global. How does that dovetail with how you envision your eventual cushioning program of expansion?
spk01: Alan, I'm not really sure I follow your question.
spk08: But I think, I have, but you actually, if you wouldn't mind, you actually give me an opportunity to present an important point that you may remember because you've followed Corset for a long time, but others may not, which is that cholera is accrued for all forms of Christian syndrome, including patients with adrenal cancer. Now, what we've noted in patients with adrenal cancer is that are really very meaningful in improving their Cushing syndrome. But as far as we can tell, it really did not do anything in particular. It did better or worse than their cancer, although their quality of life actually clearly improved. The studies that we're doing with Willow Whirl and Grace and Green are actually exclude patients with adrenal cancer. And so we're not testing that glue there. And we think that for the same reason, the reason we've got here is we think we can really offer clinical benefit in Cushing's syndrome for patients who have adrenal cancer. The really interesting thing about it is, what I talked about in my opening remarks, is whether it first stems from an observation. And the observation was immunotherapy, which is fantastic in lots of other cancers, does not seem to really work at all in patients who have adrenal And so we're hoping to see, in addition to the benefit we think we can provide in Cushing syndrome, which is really a meaningful benefit, can we also provide benefit in terms of tumor reduction and improvement in their oncologic situation? We're very excited to try. Our investigators are very excited to try that. And, you know, it seemed like a very logical place for us to start because we thought we could at least know we could provide a benefit of some kind to these patients. Where that leads, I don't know, but we're very excited to see if this first combination of immunotherapy and GR antagonism, GR modulation, actually leads to. And one last question. I'd have to ask this. You had CORT 113176 in Phase I, and the trial From what I understand, it's completed. How was it, and do you intend to take it forward at this point, and where, if at all, will the results be presented? All right. Of course, Alan, as a guy who knows more about CORSEP than some of the great people with CORSEP, thank you for bringing up court 113.176. It was still a very early stage compound. just in phase one at this point in time, but since we are really a lot of, we're covering academics here, and we collaborate with a lot of active academics, I'd also point out that from 113176 and animal models related to nervous system diseases, like ALS, Alzheimer's disease, and alcoholic use disorder, show very positive results, all of which are found in public, in peer review journals, and so forth. So this is a very interesting contrast for us. We're particularly interested in its effect in ALS, because not only did we see in the animal model a prevention of the decline of the disease, we actually saw a significantly significant improvement. This was a study done by one of our collaborators at the University of Buenos Aires Argentina. Now, on the club side, ALS is a terrible disease. Even the approved treatments don't do much, and it would be wonderful to be able to provide, you know, and improve and produce particularly therapeutic for this group of patients. On the other side is, sadly, the trail to ALS is riddled with many, many medications that do not work. So it's a hard call as to what to do. Now, you're a little bit ahead of us. We're just at the end of phase one. We have a little stuff to go here. But probably by the next time we speak, we'll be able to give an answer to that question.
spk06: Thank you. I appreciate it.
spk01: All right.
spk08: It looks like we have used your hour, hopefully in a productive way. Thank you very much for all tuning in. And we will talk to you in a quarter.
spk01: Thanks very much. Bye-bye.
spk05: Again, that does conclude the call. We would like to thank everyone for your participation.
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