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spk02: Good day, thank you for standing by, and welcome to CORE-CEP Therapeutics Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star 0. Thank you. I would now like to hand the conference over to your speaker today, Mr. Adubak Makkari. The floor is yours.
spk07: Thank you. Good afternoon, and thank you for joining us. I'm Adubak Makkari, Corsup'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 of it is available at Corsup.com. Our complete financial results will be available when we file our Form 10-Q with 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 might cause actual results to differ materially from those such statements express or imply. 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, and 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 Coraline, the initiation or outcome of litigation, our ability to obtain acceptable prices or adequate insurance coverage and reimbursement for Coraline, and risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversights, and other requirements, and the impact of the COVID-19 pandemic on our employees, consultants, and vendors, well as on our physicians, patients, insurers, regulators, and the 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 the safety, efficacy, and other clinical and commercial attributes of relacoralin, exacoralin, miracoralin, cort113176, and our other selective cortisol modulators for the treatment of patients with solid tumors, liver disease, hypercortisolism, antipsychotic-induced weight gain, amyotrophic lateral sclerosis or ALS, and other disorders. The progress, enrollment, timing, design, and results of our clinical trials, 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 programs after the COVID-19 pandemic is controlled. The timing, cost, and outcome of the litigation, including our lawsuits against Teva and Hikma Pharmaceuticals, Teva's appeal of its defeat in the post-grant review I brought before the Patent, Trial, and Appeals Board, known as PTAT, and our settlement of litigation with Sun Pharmaceuticals, as well as the scope and protective power of our intellectual property and the benefits of orphan drug designation. We disclaim any intention or duty to update forward-looking statements. Our revenue in the second quarter was $91.6 million compared to $88.6 million in the second quarter of 2020 and $79.4 million in the first quarter of 2021. Second quarter 2021 cap net income was $26.5 million compared to $28.3 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 second quarter was $38.2 million compared to $39.7 million in the second quarter of 2020. We have reiterated our revenue guidance of $355 to $385 million, which assumes that pandemic-related restrictions will continue to ease in the second half of this year. Our cash and investments totaled $471.6 million at June 30th, an increase of $16.8 million from March 31st. In the second quarter of this year, we repurchased 1.5 million shares of our common stock, 1.4 million shares pursuant to our stock repurchase program, and about 150,000 shares in connection with the net exercise of employee stock options. The total cost of these repurchases was $30.8 million. Under the current terms of our stock repurchase program, $127.6 million remains available for the repurchase of shares. We will determine the timing and size of future repurchases our stock price, and other factors. And now, Charlie Robb, our Chief Business Officer, will provide a legal update. Charlie?
spk01: Thanks, Out-of-Act. I'll briefly review our litigation against generic manufacturers Teva, Hikma, and Sun Pharmaceuticals. In March 2018, we sued Teva and Federal District Court to prevent it from marketing a generic version of Corlum in violation of our patents. Originally, trial was set to start in February of this year. Last quarter, the court vacated this date in order for the parties to be ready for trial in March. That trial-ready date was also vacated. A new trial date has not been set. In April, we asked the court's permission to file for summary judgment based on Teva's alleged infringement of our 214 patent. The court granted permission, and Teva responded by filing its own summary judgment motion with respect to the same patent. Summary judgment is a procedure whereby courts can decide a case without holding a trial. We believe the court has all it needs with respect to the 214 patent to decide the case in our favor. Having lost its action before the PTAB, Teva can no longer challenge the 214 patent's validity in the district court case. Teva can only argue that its proposed product would not infringe, a position we believe has no legal or factual support. Briefing in this matter is complete. We await the court's decision. If the court grants our motion, we will have won the case. Teva would be barred from marketing generic corlum until 2037 when the 214 patent expires. Teva could appeal, of course, although the district court's bar would remain in place until the appeal is resolved, a process that usually takes 12 to 18 months. If the court rules in Teva's favor, we will proceed to trial late this year or sometime next year. There is at present no timetable for the court's summary judgment ruling, no trial date, and no schedule for any trial-related activities. In parallel with the district court action, TEVA has, as expected, petitioned the Federal Circuit Court of Appeals to reverse its PTAB loss. Briefing in this matter is also complete. A Federal Circuit decision is likely in the first or second quarter of 2022. Earlier this year, we received notice of another antifiler, HICMA Pharmaceuticals. On March 12th, we sued HICMA in the same federal district court that is adjudicating our case against TEVA. The court has entered a schedule for the case that sets a fact discovery deadline of July 1, 2022, next year. Finally, Sun Pharmaceuticals is also seeking to market generic coralline. In June 2019, we sued Sun to prevent it from doing so. As we announced a few weeks ago, we have settled this case. The settlement agreement allows Sun to begin selling a generic version of coralline beginning October 1, 2034, more than 14 years from now, or earlier. under circumstances customary for settlements of this type. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?
spk03: Thank you, Charlie. We are pleased with our commercial results in the second quarter. Pandemic-related restrictions made it very difficult for our business to grow because those restrictions made it hard for physicians to provide and patients to receive optimal care. Diagnosing and treating patients with a complex disease such as Cushing syndrome requires frequent in-person contact. For much of the pandemic, this level of contact was, for many patients and physicians, impossible. We are encouraged that in the second quarter, particularly at the end of the quarter, our commercial activity increased notably throughout the country, clear indications that the country is opening more broadly. It is also heartening that patients recently introduced to have titrated towards their ideal dose more quickly than occurred in the last year, as many physicians are now seeing and testing their patients with pre-pandemic frequency. Looking beyond this year, we expect that our corallum business will continue to grow. Leading endocrinologists increasingly believe that there are many more patients with hypercorazolism than was once believed. Corallum is an excellent treatment for many of these patients. The foundation of our business, an effective, life-saving medication, promoted by a dedicated commercial team that puts the interests of patients first, remains rock solid. We are also excited by the potential of our clinical development programs, which have recently made important advances. From the beginning, our research and development efforts have built on the hypothesis that cortisol modulation is a powerful therapeutic mechanism in many serious disorders. Coralim's commercial success has provided and will continue to provide the funds needed to enlarge our portfolio of proprietary selective cortisol modulators and to develop the most promising. Many of these selective cortisol modulators are attractive candidates for development. Like Coralim, they bind strongly to the glucocorticoid receptor, or GR. Unlike Coralim, they have no affinity for the progesterone receptor and so don't cause some of Coralim's most serious off-target effects. Beyond sharing the qualities of strong cortisol modulation and not perturbing the progesterone receptor, preclinical and clinical testing have shown that our molecules behave differently from one another in important ways. Some cross the blood-brain barrier, others do not. Some perform best in models of solid tumors, others are more potent in models of metabolic disease. Some appear to be tissue-specific, while others have more systemic effects. Their diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders, including ovarian, adrenal, and prostate cancer, antipsychotic-induced weight gain, and non-alcoholic steatohepatitis, or NASH, and, of course, Cushing syndrome. We are now planning a Phase II trial in patients with ALS, another devastating disease with no particularly effective treatment options. And we have additional compounds in Phase I and the latter stages of preclinical development. Our oncology program is testing three mechanisms, first postulated by investigators at the University of Chicago and confirmed by other prominent researchers. One mechanism is increasing apoptosis. Apoptosis is the programmed cell death chemotherapy is meant to induce. Cortisol suppresses apoptosis. In our successful trial in women with advanced ovarian cancer, addition of the selective cortisol modulator, relacoralant, enhance the effect of chemotherapy by blunting cortisol's anti-apoptotic effect. Based on statistically significant and clinically meaningful Phase II results, we are excited to initiate a Phase III pivotal trial in patients with platinum-resistant ovarian cancer in the first quarter of 2022. As a reminder, our Phase II trial is a controlled, multicenter study of 178 women with platinum-resistant ovarian cancer who are randomized to one of three treatment arms, In addition to nabpaclitaxel, 60 women received 150 milligrams of relacoralin intermittently, meaning they received relacoralin on the day before, the day of, and the day after they received nabpaclitaxel. And 58 women received a lower daily relacoralin dose of 100 milligrams per day. 60 women received nabpaclitaxel alone. The trial's primary endpoint was progression-free survival, or PFS. The women who participated in our study were very ill. All had experienced disease progression despite prior lines of therapy. The median number of prior treatments was three. It is clear that relacoralin benefited many of these women. Those who received relacoralin intermittently exhibited a statistically significant improvement in PFS compared to the group that received napaclitaxel monotherapy. Their hazard ratio was 0.66 with a p-value of 0.038. Their median PFS was 5.6 months, 1.8 months longer than the napaclitaxel monotherapies group, which was 3.8 months. Safety and tolerability data for the two groups were comparable. The women who received a lower dose of relucorolin every day also saw their disease progress more slowly. Their median PFS was 1.5 months longer than the napaclitaxel monotherapy group. Their hazard ratio was 0.83, although this result was not statistically significant. We believe, and more importantly, our investigators believe, that these results, a 1.8-month increase in PFS without an increase in side effects, are clinically meaningful. We are honored that our Phase II trial results have been accepted for a proper paper oral presentation at the European Society for Medical Oncology, ESMO meeting, in September in Paris. Finally, we anticipate that overall survival results from this study will be available later this year. later this year. A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. Cortisol stimulation is a major reason patients treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease. Deprived of androgen stimulation, their tumors switch to cortisol activity to stimulate growth. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. We are conducting a dose-finding study of our selective cortisol modulator, exocoralin, combined with enzalutamide in men with castration-resistant prostate cancer and expect to produce clarifying data next quarter. A third oncologic mechanism recognizes cortisol's ability to reduce inflammation and suppress the immune system. effects that are often beneficial in healthy people, but in patients with solid tumors diminish the effectiveness of immunotherapy. We are conducting an open-label Phase 1b trial of relacoralin plus the PD-1 checkpoint inhibitor pembrolizumab, Merck's drug Keytruda, in patients with advanced adrenal cancer whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and Cushing syndrome, a usually quickly lethal combination. Pembrolizumab is rarely effective as monotherapy in these patients. We believe that these patients' cortisol excess may be countering the intended effects of pembrolizumab, which is to stimulate the immune system. Our trial is evaluating whether relacoralin can treat these patients' Cushing syndrome by reducing excess cortisol activity and by reversing cortisol-induced immune suppression, allow pembrolizumab to achieve its full cancer-killing effect. We plan to enroll 20 patients at five sites in the United States. The primary endpoint is objective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival. I'll now turn to our programs in metabolic disease and the recent findings of our proprietary selective cortisol modulator, Miracorrelant, in patients with NASH, a serious liver disorder. We observed that patients who received miracoralin in our Phase IIa trial exhibited large, rapid reductions in liver fat, but also substantial transient elevations of the liver enzymes ALT and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected. Reductions in liver fat of the magnitude that we observed in our study are rarely seen over any period of As a reminder, we had powered the trial to detect a 30% reduction after 12 weeks of treatment. The patients in our study exhibited reductions ranging from 39% to 74% after receiving miracoralin for just a month. It may be that the rapidity of miracoralin's fat-reducing effect caused ALT and AST to rise. One way the liver sheds fat is by metabolizing it into fatty acids, which Excessive amounts irritate the liver. Interestingly, levels of serum lipids in these patients did not increase with treatment, providing further support for the metabolism hypothesis. Our upcoming Phase 1b dose-finding trial in patients with presumed NASH will evaluate if there is a dosing regimen of miracoralin that can produce such significant reductions in liver fat without causing liver irritation. We're also evaluating miracorrelant as a potential treatment for patients with another serious and widespread disorder, antipsychotic-induced weight gain. In the United States, 6 million people take antipsychotic medications such as olanzapine and risperidone to treat illnesses such as schizophrenia, bipolar disorder, and depression. While these drugs are very effective, they exact a steep price in the form of rapid and sustained weight gain, cardiovascular disease, and other metabolic disturbances. Patients can gain a pound per week in the first 10 weeks that they take these medications, and their life expectancy is decreased on average by 20 years due in part to increased cardiovascular events, such as heart attacks and strokes. We are conducting two double-blind placebo-controlled Phase II trials of miracoralin in patients with this disorder, GRATITUDE and GRATITUDE II. These trials seek to build on the positive data from our study of miracoralin in healthy subjects. Last year, we completed a phase 1B trial in which 96 healthy subjects received olanzapine and either 600 milligrams of miracoralin, 900 milligrams of miracoralin, or placebo for 14 days. Subjects who received miracoralin gained significantly less weight than those who received placebo. They also exhibited a smaller increase in triglycerides and in ALT and AST. The paper describing these results will be published in the Journal of Clinical Psychopharmacology this quarter. The GRATITUDE trial is evaluating whether miracoralin can reverse recent antipsychotic-induced weight gain. 100 patients with schizophrenia or bipolar disorder will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of miracoralin or placebo for 12 weeks. GRATITUDE is being conducted in 30 centers in the United States. Our GRATITUDE 2 study is testing miracoralin as a treatment for longstanding antipsychotic induced weight gain. 150 patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams or 900 milligrams of miracoralin or placebo for 26 weeks. GRATITUDE 2 is being conducted at 35 centers in the United States. The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be examined. We expect to complete enrollment in Gratitude II by the end of this year and in Gratitude in mid-2022. As most of you know, relacoralin is our planned successor to Coralim for the treatment of hypercorazolism. We are evaluating it in two Phase III trials, Race and Gradient. To repeat what I said earlier, relacoralin is a selective cortisol modulator. Like coralin, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike coralin, it does not bind to the progesterone receptor, PR for short. It is not the abortion pill, and it does not cause other PR-related side effects, including endometrial thickening and vaginal bleeding. By a different mechanism, relacoralin also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in CORALIM's pivotal trial. CORALIM-induced hypokalemia is a leading cause of CORALIM discontinuation. Our GRACE trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome at sites in the United States, Canada, Europe, and Israel. Relacoralin's Phase II efficacy and safety data were strong. The trial results were recently published in Frontiers in Endocrinology. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing syndrome. There were no relacoralin-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced hypokalemia. We and our investigators are eager to take grace to the finish line. We expect GRACE to serve as the basis for our NDA submission in Cushing syndrome, which we remain on track to submit in the second quarter of 2023. Our second phase three trial, Gradient, is studying relic correlants effects in patients whose Cushing syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but ultimately their health outcomes are poor. Gradient has a planned enrollment of 130 patients and is being conducted at many of the sites participating in GRACE. Gradient is the first controlled study dedicated to patients with this type of Cushing syndrome. While we do not expect our NDA in Cushing syndrome to depend upon data from Gradient, we do expect that its findings will help improve the care of these increasingly recognized patients. Last, a brief update on our intellectual property position for reliquaryland in Cushing syndrome. As you are likely aware, we hold a composition of matter patent for reliquary that is valid to 2033. We were recently issued a method of use patent that we expect will be included in the Orange Book for reliquary should it receive FDA approval that is valid to 2040. Finally, a brief word about Court 113-176, which has shown promise in animal models of ALS. We are in discussion with leading clinicians and the FDA regarding our development plans and plan to initiate a Phase II trial by early next year. Our belief has always been that cortisol modulation can help treat many serious disorders. Correlation for patients with Cushing syndrome is one very clear example. Promising data in our ovarian cancer and NASH programs provide increasing proof of cortisol modulations, broad worth. While the pandemic dampened our commercial results for more than a year, we are confident that our business will resume its growth as conditions continue to improve. It is already growing. Even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities. Currently, our oncology program is evaluating two of our proprietary cortisol modulators in combination with three different anti-cancer agents in three tumor types. In addition, our metabolic program is conducting important initial trials in NASH and antipsychotic-induced weight gain. We also continue to enroll patients in our flagship phase three trials of Borrel, Corlin, and Cushing syndromes. and will advance court 113176 to treat patients with ALS by early next year. Meanwhile, additional proprietary early stage compounds advance towards the clinic. The breadth of our program reflects the power of our fundamental scientific hypothesis. Cortisol modulation is a potent therapeutic modality. We have proven that in patients with Cushing syndrome. We are now adding to the body of evidence improves its worth for patients with other serious disorders. I'll stop here for questions.
spk02: As a reminder, to ask a question, you will need to press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. Your first question comes from the line of Alan Long from BioWatch News. Your line is now open.
spk05: My question is, congratulations on the quarter, but I want to send kudos, especially to Sean, for executing on the sales plan in a business environment that was under transition. So I don't know if he's there, but congratulations.
spk04: Thanks, Alan. And that was Sean.
spk05: So congratulations. This is a question, I guess, for anyone. You mentioned, Joe, you mentioned about titrating coralline quickly. Are the physicians more willing to venture into a stronger dose than, say, even a couple years ago or a little more?
spk04: Joe, would you like to take that question? Yeah, so just the question is, are physicians now more readily open to titrating to a higher dose? Was that the question?
spk05: Yes.
spk04: And then are you asking that specifically to how it may be different than during the pandemic?
spk05: Well, could be, but more really as the physician community, I would expect having more experience or reading more literature or talking to their mate about their experience with Coraline may feel a little bit less reluctant to raise the dose to an optimal level.
spk04: Yeah. I mean, I would say you've hit the nail on the head with that right there. I mean, physicians that have had more experience with a compound are more comfortable using it, are more comfortable with the cadence of patient visits that are required to follow up, have definitely moved to titrate to a higher dose and the most efficacious dose for that patient. Now, I think an important point is that it really does vary patient by patient. It's patients Is there anything, Joe, you want to add to that?
spk03: I think, Alan, I think really what you're getting at is is the behavior different than it was several years ago? And the answer to that is right now it really isn't at all. I think that's actually a real positive. It's a very interesting point, which is that we're now seeing physicians titrate their patients' doses at the same cadence that we saw pre-pandemic, not more than that. Because at that point in time, they really were getting to patients their ideal dose. The interesting thing, you know, and again, there were strange things in the pandemic in many areas, was that because doctors could not see patients as frequently, it seemed as if they were not on the same cadence of titration. And so it's just heartening to see that they've returned to pre-pandemic behavior at this point. But overall, our average dose per patient is very similar for now many years.
spk05: I have one more question. It could be to Joe or to Andreas. Regarding the recent NASH results, you had a rapid liver fat reduction and inflammatory markers going up. Did you see any notable similar phenomenon with other NASH drugs, either in preclinical or or in human trials done in the literature?
spk06: Well, if you're referring to like a transient increase of transaminases in patients with NASH that are treated with drugs to reduce liver fat, there are reports in the literature that it is a known phenomenon. It's just a The scale was different when we looked at those, both the scale of the liver fat reduction and the scale of the transaminase elevation. What's been described by some of the other NASH compounds is an increase of AST and ALT of like 20%. And we had looked at a much bigger increase. But that's why we're going forward and trying to find our sweet spot where we achieve a good reduction in liver fat without affecting the liver negatively on the way to that.
spk03: I mean, I think that's exactly right, Andreas. And I just want to add a little color to that, Alan, which is to say, you know, the question is, has this phenomenon been observed of simultaneous decrease in liver fat and increase in liver function sets? The answer to that is yes. But Andreas' point is also, the second point is also an important one. Never on the scale that we saw, no one has seen the kind of rapid fat decrease in their studies. And at the same time, the liver elevation and liver function test, which normalized as soon as the drug was withdrawn, no one's ever seen that either. And so really, to take Andreas' conclusion as it is, what we're really looking to do is if we can really harness this extreme activity without irritating the liver, that's really the goal. And that's what the next study we were looking for, the ideal dosing regimen, is going to address.
spk05: Thank you for taking my questions. It looks like a pretty interesting next 12 months. Yeah.
spk03: Thank you, Alan. Thank you.
spk02: Your next question comes from the line of Matt Kaplan from Barry Tenman.
spk10: Hi. Good afternoon, guys, and thanks for taking the questions. Just wanted to, you know, first congrats on the strength of the quarter, a nice rebound in the revenues for Coraline. Let's dig into your pipeline a little bit. Can you, I guess, first give us an update in terms the pace of enrollment and how enrollment is going with the Reliquant Phase 3 grade study and Phase 3 gradient study in Cushing's syndrome?
spk03: Yeah. I mean, as I said, Matt, in my remarks, we have not changed the timeline at all. It's just as it was before. You know, and the only caveat I would add to that is You know, we're in an uncertain time in the world. We see no need at the moment to make any alterations. Things certainly are better than they were a year ago, but we'll just have to see what happens. So I just would refer you to that. The timelines are unchanged. Okay.
spk10: Okay. That's helpful. And then I guess you're on track to start your – phase three study in ovarian cancer in the first quarter of next year. Can you give us a little color in terms of what that study will look like in terms of design and endpoints and stuff like that?
spk03: Yes, let me just turn that question over to Andreas.
spk06: So we are finalizing some of those questions, and obviously many of them are important. I think there are a few things that are clear. One is the dose or the regimen that we're going to test is the intermittent regimen. The comparator, we're favoring currently a physician's choice comparator. So we would give, like a dealer's choice, we would give a physician the choice of a single agent chemotherapy in these platinum resistance or refractory patients. And the primary endpoint, I think our ongoing position is overall survival is going to be required as a primary endpoint for approval. But we're having a lot of conversations with high-level opinion leaders, and we'll obviously eventually pretty soon have conversations with the regulators to affirm those assumptions. Okay.
spk10: That's helpful. And then I guess lastly in terms of the work you're doing, with myrcorrelant and metabolic diseases, specifically antipsychotic-induced weight gain. How are those studies progressing now, and when could we expect some readout from those?
spk06: Yeah, I mean, I'm sure you've read what we shared in the press release, right? But we want to complete enrollment in the GRATITUDE 2 study by year end, initial gratitude study by mid-2022. We're on track for that, and then obviously we'll have to flip the cards over and see what we observe in these trials. So we're quite excited about it and hope that we can demonstrate a treatment benefit.
spk03: And Matt, what I'd just add to that is, as you know, the pandemic created different pressures in different sorts of studies. At the moment, we're actually seeing things, you know, progress right along. I just, again, I'll just add what I said before. You know, it's an uncertain world. But at this moment in time, we really are fine with what we're seeing. And as I said, we've repeated our timelines.
spk10: And just a follow-up on that in terms of your work your sense in terms of moving, what you need to see from an impact point of view on the weight gain and the unmet need, I guess, in this patient population, and where Murocorrelant could play a role there.
spk03: Well, let me address this one because, Matt, as you know, these are my patients. I mean, every psychiatrist prescribes these medications. They're very effective for what they're intended to treat, which is psychosis or as adjuncts to antidepressants in major depression or bipolar disorder. So from an advocacy point of view, they're very good. Unfortunately, they have this terrible metabolic Achilles heel, which is that they really perturb that system. They cause weight gain, and even though I didn't mention it in my remarks, that's actually a problem for treatment adherence. People don't like how they look. They don't like how they feel. And if they are disciplined enough to stay on the medications, ultimately, they develop a lot of the diseases you see with 10% or 15% weight gain or sometimes more than that. There's no doubt among physicians who treat these patients that there's a great need for something to do with this problem. And so, you know, again, I sort of look at where both hats here. As a treater of these patients and someone developing medications for them, I really believe that if you could come up with something which would help those issues, it would be very, very meaningful. It's a large market with a lot of suffering. And we'll just have to see. I mean, the studies are set up to demonstrate both weight change and, I think, importantly, to metabolic perturbations that come with that. I mean, weight change is good, but it would be much better if you could actually develop something which helped with some of the other problems, like things like increase in triglycerides or fasting insulin, things which make people less prone to diabetes. Thanks for giving me the opportunity to expand it some length. This is a mental illness as a whole, has a lot of stigma and isn't talked about. Within it, this is a big, big problem, and hopefully we can do something about it.
spk09: Thanks, John. That's helpful to put into context. Thanks for taking questions. Sure. Thanks.
spk02: Your last question comes from the line of Arthur He from HC Wainwright. Your line is now open.
spk08: Good afternoon, everyone. This is Arthur for RK. Thank you for taking my question. Most of my questions have been answered. So I'm just curious, besides the Shell Bike program, has management discussed any other plan to further improve the shareholder value
spk03: Oh, we discuss it continuously, but you know our plan. No, look, the most important thing we can do to increase shareholder value is for our programs to succeed and our commercial program to continue on the path that it's at. Other ancillary things we really do review, our board is very conscious of things like that. We feel that our stock is at an inexpensive price right now. As you know, we're committing our own funds to it, and we will continue to do that. But, no, beyond that, when we have something more specific, Arthur, we'll talk about it.
spk08: Thank you. Thank you for that, and congratulations on the strong quarter. Thank you very much.
spk03: And I want to just thank everyone else for listening in. I'm sure it's a hot summer afternoon wherever you are, so stay cool and healthy, and we'll talk to you next quarter.
spk02: This concludes today's conference call. Thank you all for participating. You may now disconnect.
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