Corcept Therapeutics Incorporated

Thank you for standing by, and welcome to CoreSep Therapeutics' second quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. I would now like to hand the call over to Adhavok Macari, CFO. Please go ahead.

Thank you. Hello, everyone. Good afternoon, and thank you for joining us. Today, we issued a press release announcing our financial results for the second quarter and providing a corporate update. The copy is available at coursef.com. Our complete financial results will be available when we file our Form 10-Q with the SEC. Today's call is being recorded. A replay will be available of the investors' past events to have on our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which might cause actual results to be materially different from those such statements express or imply. The risks and uncertainties that may affect our forward-looking statements are described in our annual report on Form 10-K and our quarterly reports on Form 10-Q, all of which are available at the SEC's website. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements. Our revenue in the second quarter of 2020 was $194.4 million compared to $163.8 million in the prior year period. We have modified our 2025 revenue guidance to $850 to $900 million. Net income was $35.1 million compared to $35.5 million in the second quarter of last year. Our cash and investments on June 30th were $515 million. Balance reflects our acquisition of $115 million of our common stock and the second quarter pursuant to our stock repurchase program, the net exercise of stock options by course of employees, and the net testing of restricted stock grants. I'll turn the call over to Sean Maduke, president of our endocrinology division. Sean?

Thank you, Adelbach. The endocrinology division had an excellent second quarter. For the sixth quarter in a row, we added a record number of new prescribers and new prescriptions, and there are a record number of patients on therapy. We shipped more tablets to patients than ever before, 49% more, in the second quarter last year. Our financial results don't fully reflect this surge in demand. While our quarterly revenue growth was substantial, a $37 million increase over the first quarter, it should have been more. I discussed on the last call the insufficient capacity of our pharmacy vendor. Its capacity has increased in the second quarter, but not as much as we expected, and not enough to keep pace with our growth. Capacity will increase further in the second half of the year. We dispensed another record number of tablets in July, with more increases to follow. We are also bringing online a second pharmacy. You will see the financial impact of this addition in the fourth quarter. Increased pharmacy capacity is important because I'm certain our growth is poised to accelerate. For many years, physicians only screened and treated the most physically obvious cases of hypercortisolism. In the last 15 years, many studies have been published supporting the identification and the treatment across a much broader spectrum of disease. The results of the Catalyst study confirm and build on these findings and will lead to much higher rates of screening and treatment of hypercortisolism. The study unequivocally shows that one in four patients with difficult-to-control diabetes have hypercortisolism, and that treatment with a cortisol modulator dramatically improves many of their signs and symptoms, even when all current medications, including Ozempic and Manjaro, have not. The catalyst results are now published in Diabetes Care, the field's leading journal. This crucial information is now being absorbed by the broader physician community. We have amplified our efforts to educate physicians about hypercortisolism, and we will ramp those activities even further. For example, we've increased the size of our sales force substantially, and we'll continue to grow that team. We currently have 145 clinical specialists, up from 60 at the beginning of 2024, and our plan is to have 175 in place before year-end. In the increasing context of a much better understanding of the prevalence of hypercortisolism, I'm eagerly anticipating Relacorlin's approval. While Corlin is a great medication, Relacorlin is even better. Relacoralin will be a terrific option for both prescribers and patients. I expect that almost all patients who are receiving Coraline will choose to transition to Relacoralin, and our growth will accelerate when it becomes available. I've never been more confident in both our current and future commercial growth, and most important, our potential to help many more patients. I believe that in the next three to five years, Relacoralin will generate $3 to $5 billion in annual revenue in hypercortisolism alone. I'll now turn the call over to Charlie Robb, our Chief Business Officer. Charlie? Charlie?

Thanks, Sean. At last, there is something to report regarding our patent litigation with Teva. Recall that in 2018, we sued Teva to keep it from marketing a generic version of Coraline in violation of our patents. The trial took place in September 2023. In December 2023, the district court ruled against us. We appealed that decision to the Federal Circuit Court of Appeals and completed briefing in May 2024. A few weeks ago, on July 7th, the court heard oral argument in the case, the last step before issuing an opinion. The three-judge panel was led by Chief Judge Kimberly Moore. In 2021, Judge Moore was a member of the panel that rejected Teva's challenge to the validity of one of the patents we asserted at trial and wrote the opinion in our favor. I don't mean to suggest that Judge Moore's favorable decision in 2021 means she is more likely to rule for us now. The issues now are different. Judge Moore's decision in 2021 concerned the validity of our patent. She found it valid. The current argument concerns infringement. Will TAVA infringe our patent? An entirely different question. My point is simply that Judge Moore is not new to this dispute. She understands our particular situation, not just the law in the abstract. For a party that believes, as we do, that the law and the facts are on its side, Judge Moore's patent expertise and depth of knowledge is a good thing. It is impossible to say when the Federal Circuit will issue its decision. Sometime in the next two to three months would be a reasonable guess. If we prevail in this case, Teva will lose FDA approval of its product until the expiration of our patents in 2037. As I've said before, we are eager to resolve this appeal. We strongly believe our position is correct and that the Federal Circuit will agree. I will now turn the call over to Dr. Joe Belanoff, our Chief Executive Officer. Joe?

Thank you, Charlie. And thank you everyone for joining us this afternoon. After many important years building this point, the next era at Corecept is about to arrive. As we have always known, cortisol enters all organs of the body and modulating its effects has the potential to be useful in many diseases. We now have two new drug applications, NDAs, in progress in hypercortisolism and platinum resistant ovarian cancer. The results of the studies leading to these NDAs were published in major medical journals in the second quarter. We have also generated promising results in our ALS and liver disease programs. In short, we have established a new medical platform useful to many patients suffering from serious disorders. The results of our CATALYST trial, the largest and most rigorous trial ever conducted to assess the prevalence and treatment of hypercortisolism in patients with difficult to control type 2 diabetes, will transform medicine. The prevalence phase of CATALYST demonstrated that one in four of these refractory patients has hypercortisolism, a far higher rate than was previously assumed. In April, these results were published in Diabetes Care, a leading peer-reviewed journal of the American Diabetes Association. Patients who enrolled in the treatment phase of Catalyst had uncontrolled diabetes despite receiving multiple glucose-lowering therapies, including the most potent GLP-1 agonists. Even so, in only 24 weeks, patients treated with coralline experienced a 1.47% reduction in hemoglobin A1c compared to just 0.15% for those receiving placebo. The p-value of this result was less than .001. In addition, patients saw significant improvements in a range of additional endpoints, including reductions in body weight and waist circumference. Notably, patients and catalysts experienced these improvements even as they decreased or entirely discontinued their other glucose-lowering medications. The results were presented last month during a keynote session at the American Diabetes Association's 85th Scientific Sessions with a simultaneous publication in Diabetes Care. Catalyst findings will substantially accelerate the screening and treatment of hypercortisolism. Leading diabetologists are advocating for their quick integration into treatment guidelines. Concurrent with the rapidly increasing physician awareness of hypercortisolism, Relacoralin is approaching approval. Its PDUPA date in hypercortisolism is December 30th. Relacoralin's NDA is supported by our pivotal Phase III GRACE trial, as well as our gradient, long-term extension, and Phase II trials. In these studies, patients treated with relacoralin experience clinically meaningful improvements across all of the signs and symptoms of hypercortisolism. including hypertension, hyperglycemia, weight, lean muscle mass, waist circumference, cognition, Cushing's quality of life score, and other important clinical measures. These benefits were observed consistently and durably with improvements emerging early and continuing or deepening over time. Equally noteworthy are relicoral and safety characteristics. Relicoral has been well-tolerated in all of its studies, Importantly, no instances of drug-induced hypokalemia, endometrial hypertrophy, vaginal bleeding, adrenal insufficiency, or QT prolongation have been observed. These adverse events can have serious health consequences and are associated with one or more of the currently available therapies. We expect that relachoralin's efficacy and safety will make it a new standard of care for hyperchorizalism. As awareness of the disease and its ability to be treated grows, Many more patients with hypercortisone will be identified, and CoreSept is well positioned to help them. As Sean said earlier, we are confident that our Cushing Syndrome business will continue to grow for years. Since the founding of CoreSept, our research and development has been built on the hypothesis that cortisol modulation can be a powerful therapeutic mechanism in many serious disorders. The success of our pivotal ROSELLA trial and platinum-resistant ovarian cancer provides clear evidence that cortisol receptor antagonism has substantial potential in oncology. In Rosella, 381 women with platinum-resistant ovarian cancer were randomized one-to-one to receive either napaclitaxel, the most potent chemotherapy currently available for these patients, or napaclitaxel plus relacoralant. In these patients, the efficacy of napaclitaxel and chemotherapy in general, had diminished markedly. Our expectation was that relucoralin would blunt the anti-apoptotic effect of cortisol activity, thereby resensitizing ovarian tumors to the effect of napaclitaxel. This expectation was resoundingly confirmed. The ROSERO trial met its primary endpoint of improved progression-free survival. Patients treated with relucoralin plus napaclitaxel experienced a 30% reduction in their risk of disease progression compared to patients treated with nabpaclitaxel alone, the hazard ratio of 0.7 and a p-value of 0.008. At 12 months, 25% of patients in the relacoralin arm remained progression-free, almost twice as many as in the control arm. In the interim evaluation of overall survival, patients treated with relacoralin plus nabpaclitaxel had a median overall survival of 16 months compared to 11.5 months for those receiving nabpaclitaxel alone. The hazard ratio was 0.69 with a p-value of 0.01. These results were obtained without the need for a biomarker diagnostic test, a prerequisite of many currently available treatments, and were even observed in patients with particularly poor prognoses, such as patients who had received multiple lines of prior therapy and patients who had progressed well on standard of care therapy. Relacoralin plus napaclitaxel was well tolerated. The adverse events observed were consistent with the known safety profile of napaclitaxel. Because patients in the relacoralin plus napaclitaxel arm fared better than those in the napaclitaxel monotherapy arm, they had an approximately 30% longer duration of napaclitaxel therapy. When adjusted for treatment duration, the safety profile of roacorolin plus napaclitaxel was very similar to that of napaclitaxel alone. The results of the Rosella study were presented last month in an oral weight-breaker session at the American Society of Clinical Oncology's annual meeting and simultaneously published in The Lancet, the general medical journal with the world's highest impact factor. Physicians have responded with great enthusiasm to these results. Improving progression-free survival and overall survival without an added safety burden positions Relacoralin to become the new standard of care for patients with platinum-resistant ovarian cancer. We submitted Relacoralin's NDA in platinum-resistant ovarian cancer earlier this month and will submit a marketing authorization application in Europe soon. In anticipation of a successful regulatory outcome, we have made substantial progress in establishing a dedicated oncology division. We are prepared to move swiftly to bring relucoralin plus napaclitaxel to the women who can benefit from it once it is approved. Rosella established relucoralin's therapeutic value in a highly challenging stage of ovarian cancer. These results support relucoralin's potentially broader utility. including in earlier stages of ovarian cancer and in other solid tumors. The first step in advancing this strategy is with our BELLA trial, which is enrolling briskly and will test whether combining relacorlin plus nab paclitaxel with devacizumab offers an additional effective option for patients with platinum-resistant ovarian cancer. We will soon begin additional studies. In addition to exploring cortisol receptor antagonism's potential to resensitize tumors to chemotherapy, we are evaluating its use in combination with androgen deprivation therapy in prostate cancer. Cortisol stimulation is a major reason why patients with prostate cancer 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 collaborators at the University of Chicago are currently enrolling a randomized placebo-controlled phase two trial of relacoralin plus enzalutamide in patients with early stage prostate cancer to determine if cortisol receptor antagonism can block this tumor escape route. Another possible role of cortisol receptor antagonism is in combination with immunotherapy. Because cortisol suppresses the immune system, it may blunt the effectiveness of cancer therapies intended to stimulate an immune response. Adding a cortisol receptor antagonist to immunotherapies, such as checkpoint inhibitors, may enhance their effectiveness. Following our Phase 1b trial in advanced adrenal cancer, we are deciding how best to investigate the utility of our compounds in combination with immunotherapies in other tumor types and earlier stages of cancer. Our proprietary compound, Dazocoralin, is an excellent candidate for the treatment of neurologic disorders. While our DASELS trial, a 249-patient randomized double-blind placebo-controlled phase two trial of Dazocoralin in patients with ALS, did not meet its primary endpoint of improvement in the ALS functional rating scale, the data did suggest a powerful benefit, prevention of early death. One year after entering DASLs, patients who received 300 milligrams of Dazacorilone daily exhibited an 84% reduction in death, the risk of death, compared to patients who only received placebo. The p-value for this finding was .0009. The benefit emerged in the first 24 weeks of the study during which time five patients randomized to placebo had died compared to no deaths in the group that received 300 milligrams of diazochloroquine. An important point to know about this survival benefit is that it emerges from the start of treatment when patients still retain considerable function and quality of life. The common understanding of ALS is that it progresses by degrading motor function until patients are completely paralyzed with death following. While this is true in some cases, many more patients die long before then from conditions such as pneumonia that they would have survived had it not been for their ALS. It is these early deaths that patients receiving dasichloroquine experience less frequently. We presented these notable findings last month at the European Network to Cure ALS annual meeting. We are engaged with regulatory authorities to determine the fastest path for advancing dasa-correlant. MASH, metabolic dysfunction associated with the auto-hepatitis, is a serious liver disorder that afflicts millions of patients in the United States and globally. Cortisol activity plays a role in both the initial development and progression of the disease, and cortisol modulation may serve as a treatment. One of the proprietary molecules, miracorrelant, has very potent activity in the liver. Our Phase 1b study showed that miracloralin rapidly reduced liver fat and improved other markers of liver health, fibrosis, and metabolism. Miracloralin was also very well tolerated without the GI side effects commonly seen in patients being treated for MASH. Our randomized, double-blind, placebo-controlled Phase 2b MONARCH study aims to expand on our encouraging Phase 1b results. Monarch has two cohorts. The first cohort of patients has biopsy confirmed MASH. The second cohort consists of patients with presumed MASH. Enrollment in Monarch will be completed in the next few weeks and results will be available late next year. As I said earlier, this is the dawn of a new era at Corecept. Let me reiterate our important developments. The CATALYST trial, the largest and most rigorous of its kind, proves that there are far more patients with hypercortisolism than was previously believed, and that cortisol modulation is very beneficial for these patients. With results from both phases of CATALYST now published, leading physicians are recognizing the significance of the findings and joining us in raising awareness. We are certain that this will lead to many more patients being screened, identified, and properly treated. While Chloralum's effectiveness in treating hypercortisolism is well established, Relichloralum is a substantial advance. Its strong efficacy and safety positions it to become a new standard of care. We expect its approval on hypercortisolism by the end of this year and are eager to make it available immediately thereafter. The ROSELLA trial validated cortisol receptors antagonism's utility in oncology. Relichloroquine delivered clear clinical benefit with no added side effect safety burden in patients with platinum-resistant ovarian cancer treated with napaklitaxel. We expect relichloroquine's improvement in oncology next year. We are working to unlock its potential in earlier stages of cancer, other tumor types, and in combination with other anti-cancer agents. In addition, we are actively exploring the potential of cortisol modulation to treat a broad range of additional severe diseases, including neurologic and hepatic diseases. We continue to discover and develop proprietary selective cortisol modulators with likely very distinctive clinical attributes and are advancing the most promising to the clinic. Cortisol modulation's vast potential to help many patients is just beginning to unfold. It is a very exciting time at Corset. Operator, let's proceed to questions.

Thank you. As a reminder, to ask a question, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of David Amselem of Piper Sandler. Please go ahead, David.

Thanks. So I have a few Coraline-specific questions. First, I actually want to ask you about the authorized generic. What portion of your business came from the authorized generic during the quarter relative to 1Q? And can you talk about the pricing headwind in percentage terms year over year? So that's number one. Number two is just with the supply chain issues and fulfillment issues, can you talk about the disconnect between prescriptions that are actually written and prescriptions that are actually filled? In other words, what portion of prescriptions that were actually written were pulled through to actual filled prescriptions, and did that gap narrow down? in the second quarter. In other words, were the fulfillment issues, for lack of a better term, less bad in 2Q versus 1Q. So I'll stop there.

All right.

Well, thank you, David.

I think we understand exactly what you're asking. And I just want to pass you over to Sean Maduk. Sean, as you know, is the president of our endocrinology division, and these are things that are on his plate every day.

David, thanks for the questions. I'm going to touch on the AG question first. So if you recall on the last call, we had stated that just over 50% of our business had transitioned over to the AG. Over the course of the second quarter, we're now at about two-thirds of our business. So we've seen sort of that transition slow. We expect, you know, over the next six months, maybe a little bit more movement, but we have seen some stabilization. So, you know, a percentage point here or there, but I think we'll settle at the end of the year around two-thirds of our business. In terms of the pricing question you asked, when we launched our AG in June of last year, we launched it at a 12% discount to Corlum's list price. But you know that's a starting point with payers, right? Payers negotiate. And so it varies by payer contract. But when you look on average across all of our contracts, it's about a 30% discount to Corlum's list price.

Thank you, Sean.

Okay, so now in terms of your question, before I talk about the supply chain specifics, I do want to spend a couple of minutes talking about the health of our business, and then I'll talk specifically about the pharmacy. So we had an excellent quarter. I mean, we grew our volume by 49% year over year, and it could have been more, and I'll talk about that in a minute when I talk about the pharmacy. So why is our business growing, and why is it so strong? Well, the first point is the market is expanding. There has been a significant amount of data over the last couple of years, most notably Catalyst, and Joe referenced this in his comments, but it has made a real splash. Physicians are way more interested today than they were a couple of years ago. It's expanding the conversation. We're getting in front of them. A real-life example of this, we monitor this, of course. A real-life example is at the Endo Conference about three weeks ago here in San Francisco, the Endo Society Conference, we had a presentation on the Catalyst data in a room that had seats for about 225 people. 500 people attended that session. There were more people standing than sitting. And that would have been absolutely unheard of two years ago. And here we are today. That's driving, again, more conversation, more outreach with CoreSept, and we're working hard to make sure that information is disseminated broadly so that physicians are actively looking for these patients, which is exactly what they're doing. There's more screening going on, and more patients are being diagnosed. And because of that, our colon prescriptions have increased significantly, over the last few months. And that's just going to continue. We expect we're just really at the start of that. And to put that in perspective, I mean, we now have days that we get more Coraline new patient prescriptions than we used to get in a month. And again, it's just the start of that. We're just at the start of Catalyst. We think that's going to accelerate through the rest of the year and really lay a very strong foundation for Coraline, which, of course, we're very excited for, which is going to come at the beginning of next year. So in terms of your specific question around the pharmacy, I mean, in short, the pharmacy just did not meet our expectations. They improved in Q2. They got closer to where we were, but not all the way. And, you know, the best way that I think I can explain this is to use a bit of an analogy. And bear with me for a second. I'm going to talk about cars for a second here. But assume that, you know, a few months ago, Optime was operating in a car that was driving about 60 miles per hour. Corsac was in a car that was driving 70 miles per hour. And we needed them to catch up, not just catch up, but sustain their speed to support our business. They improved. They got closer to where we were. But that's the operative word. Where we were is not where we are today. This is not a static business. Our business continues to grow and to accelerate. And we're now driving at 80, 85 miles per hour. So you asked specifically, you know, is the gap narrowed? I mean, there's been such a flood of volume, you know, it's continued to create a problem. And when you Look, to quantify that, that probably had about a $15 million impact on our second quarter results. So heading into the second half of the year, you know, where are we? Well, we saw improvement. We expect that we're going to continue to see improvement in the third quarter, and we expect that we're going to continue to see even more improvement with our current pharmacy vendors through the end of the year. But as we said in our opening statements, we're also onboarding a second pharmacy, which we're very excited about, that will support our business both today and in the future with Reliquorlin, and we expect them to start contributing in the fourth quarter.

Thank you, Sean. Next question, please.

Our next question comes from the line of June Lee of Truist Securities. Please go ahead, June.

Hi, Jim. Thanks for the update and for taking our questions. Regarding the $3 billion to $5 billion in peak sales opportunity for your hypercortisolism franchise that mentioned on the call, how much of that is coming from Corlin? And given the pending approval of Rella Corlin, how important is it to you that you win on the ongoing appeals process with PEPA?

And I have a follow-up. I'll be glad to take that question. I want to reiterate a few of the points we've made. already, but they're important, which is that relacoralin is a better medication than coralline. Coralline works extremely well, but relacoralin has very, very tangible advantages, and we think that relacoralin ultimately will entirely replace coralline. There's also another point, which is that we think that we have penetrated a very small percentage of the overall potential market. There are many more patients with hyperchlorosolism to be treated than have ever been treated. So our longer-term estimates, you know, the one you referenced, 3 to 5 billion, certainly takes into account relative coralline. It really has, in some sense, very little impact from coralline at that point. But maybe just another important point to make, which we don't often say out loud, is we don't think 3 to 5 million are peak sales. I mean, 3 to 5 million is what we think we can do in 3 to 5 years. But we think that this market is substantially larger than that, and we will have a substantial piece of that substantial market.

Thank you for the clarification. The other part of this question was around the patent. Please repeat the other part of the question.

The other part of this question was, does winning the patent case impact the $3 to $5 billion?

Winning the patent case does not impact the $3 to $5 billion. What impacts the $5 billion is because that's a coral patent case. We think that, of course, maybe everyone in our situation, we think we have a very good reason to win the patent case. But in some sense, that's looking through the rearview mirror. This is really about the advancement of Relic Coraline and its future growth.

Understood. Thank you so much. A quick follow-up. When will the second pharmacy come online? And at what point would you consider activating more distributors? Because Isn't that sort of the plan for Relaforland, which, you know, you think and we think will have a broader, you know, adoption?

Yeah, I'm going to pass you back to Sean for that answer.

Yeah, so thanks for the question. So the onboarding of that pharmacy is in process and we expect them to contribute sort of value and have an impact in the fourth quarter. You know, we, to your second question and comment, we had always planned to expand this network for for Relic Coraline. And it really was the surge of demand that we saw with Coraline that caused us to sort of pull that back a quarter. And that's why we're accelerating this. But to your question about will we expand further, it's something that we're looking into. I mean, we're being very thoughtful as we set up our current structure with the addition of the second pharmacy so that we have the ability to add to that should we see fit. So something we're always looking at and we will do that if we see fit into the future.

Thank you. Thank you. Next question, please.

Thank you. Our next question comes from the line of Swayampakula Ramakant of HCW. Please go ahead.

Thank you. Hi. A couple of quick questions. Yes. So, you know, you have initiated the catalyst study, you know, a couple of years ago. So you were, even before you were kind of confident that the data was going to come from Catalyst because you were always aware that the patients are not being identified as much as they should be. Where I'm leading to with that question is what steps were missed in not having a second pharmacy on board earlier in time because you knew that there was going to be an upsurge of of this demand from the market, especially once the data comes out. And the other question is, the expectation that the second pharmacy is going to come on board in the fourth quarter, why are we still pulling down the guidance? Does that mean there is something else that we are not understanding?

Okay, let me see if I can order those questions. I think I'll try the first question, and I'll give Sean the second question. First question is, why didn't we get it a second time sooner? And, you know, I'll be honest, hindsight 2020, good question. And I think that part of it was that sort of a combination of things. The build from the catalyst information has gone much more rapidly than we thought. And frankly, we thought that our original pharmacy would be able to keep up and, you know, live and learn. The demand has been even greater than we thought it was, and our current pharmacy wasn't able to stay with it. So, Sean, the second question?

Yeah, so the second question was, given the second pharmacy coming on and adding value in the fourth quarter, why change? So, look, we take all factors into account when we look at our range. And One of the challenges is, as I mentioned earlier, the impact of the patient delays, and that's what's happening here. It's taking longer for patients to start medication. It was a $15 million impact in the second quarter, but that doesn't just go away. I mean, that sort of flows through the model. It takes longer to start patients. It takes longer to titrate up. And when you do sort of the math throughout the course of the year, it has the potential to be a larger impact than that 15. So that was the main driver.

Thank you, Sean.

Next question, please. Yeah, thanks for the clarification. On the Bella study, what's the timeline for that? And also, in terms of evaluating relic correlant in other solid tumors, is that basically the prostate cancer that you're talking about, or is there any additional solid tumors that you'll be looking at?

Thank you very much for asking that, R.K., and that gives me an opportunity to reintroduce you to Bill Geyer, who is our Chief Development Officer. This is all his domain, and I'll let him get started.

Great. Thanks, R.K., for that question. So for the BELLA trial, enrollment has gone better than expected. I mean, our Phase 2 and a Phase 3 study is using reliquilin plus napaxifaxil enrolled also very quickly. This is going even faster than that, and so we will have this study enrolled by the end of this year. and therefore we'll see results about a year after that. And when it comes to other solid tumors, I'll comment on there. Yeah, prostate cancer is one of those, but we're thinking much bigger than that because our vision for L-Coordination is to establish its role as an agent capable of synergizing with many other agents to enhance efficacy with no added toxicity in many different tumor types. Now, on the near term, we're going to study and move forward in looking at... moving up in the treatment paradigm in ovarian cancer. And we'll be expanding across gynecological oncology spaces like endometrial cancer and cervical cancer. And when we look at other solid tumors, I'll give you more details in the coming weeks by the end of this year, but we're going to be also looking at other selective glucocorticoid receptor antagonists in combination with other agents like immunotherapy. Finalizing our oncology development plans is ongoing. We've got a great plan, and we will give you the details very soon.

Thank you. The last question from me, Joe, is on the conversation with the FDA on the ALS front. Did you already have that conversation with the FDA And if not, what's the strategy there? Do you think as soon as you get them to agree for another study, would you be doing another study or would you want to utilize whatever data you have to file?

I think we heard and understand your question. And I'm going to pass you back to Charlie Robb. Charlie is our chief business officer, and he oversees all of our regulatory interactions.

Hi, RK. So we've not yet had the meeting, and we said in the last call that we were going to contact the regulators immediately, which we did. So we have a meeting scheduled later in August to discuss the path forward. And one of the options is certainly an approval based on the data we have now. That would be an unusual thing no one should count on, but we're putting that forward as a very serious possibility and a subject of conversation with the regulators. The other, of course, would be the optimum design of a confirmatory trial, which we would expect to conduct in any event, whatever the use of the Phase II data we have now turns out to be. So when we have that meeting and settle on our plans, we will let folks know about it. But that's sort of the state of play right now.

Thank you. Thank you, Charlie. Good luck and talk to you guys soon.

Yes, thank you. Thanks for the questions. Next, please.

Thank you. Our next question comes from the line of Edward Nash of Canaccord Genuity. Please go ahead, Edward.

Hi, good afternoon. This is Xinwei Ong for Edward. Thanks for taking our questions. My questions are focused on the RELA for platinum-resistant ovarian cancers side of things. So the first part of my question is maybe could you help us understand Rella positioning in the current treatment paradigm? Because, you know, you mentioned that it is the expectation that Rella can help treat earlier stages of ovarian cancer. So does this also include patients that are not platinum resistant?

Yes. You know, I think I caught most of your question. And if we've missed anything, ask us and clarify. But I wanted to introduce everyone to Roberto Riera, who is president of our oncology division, and he is all over this material. So please, Roberto, start, and if we've missed something, let us know.

Thank you for the question. So let me just start by saying that since we have presented our data at the hospital, we have had the opportunity to speak with a wide range of key opinion leaders in the field. We have also ran a comprehensive market research, getting input from a large number of treating physicians across all major U.S. regions. And the feedback on the Rosella results has been very, very encouraging to us. It speaks really to the strength of the data we have. So we are very confident about our path to market leadership, specifically in platinum-resistant ovarian cancer, and we believe Relacore Lending has the potential to deliver over a billion dollars in long-term revenues. Now, specifically to your question about positioning, The Rosella trial data supports ralcoriline as a flexible option that can be used in multiple lines of therapy, both before and after biomarker-specific agents like yellow hair, for example, which was very much corroborated by the market research I alluded to before.

Okay. Yeah, thanks. That's very helpful. So I guess... Since you already mentioned maybe squeezing in a follow-up over here, in your discussion with physicians, are you finding that they will tend to use Ravacoridans in earlier stage patients or rather to, you know, preserve or sort of preserve the drug for late stage patients because of its safety profile, which is positive and, you know, for late stage patients, usually there's not that many options out there.

Please, Roberto.

Yeah, so our data, as you know, looks into patients with multiple lines of therapy early and late. So it supports flexible utilization, as I mentioned before. But as we speak to physicians about this, it's not just the efficacy. They actually look into the safety as a very strong attribute of this regimen. and the oral as well, it's also something that really appeals to them. So we see significant utilization in earlier lines of platinum-resistant ovarian cancer and potential for utilization even earlier as the data evolves.

And I would just like to add to that one point that Bill alluded to. I think that our trial in platinum-resistant ovarian cancer, Rosella, enrolled twice as fast as any other study which has ever been completed. in that disease, and I think that the current study, the Bella study, you know, we really have to keep up. I mean, the enrollment is really so brisk there. And I think it speaks to the ease of use of this drug in combination. So, you know, look, we've done our research, and we're only speculating until we actually get to the market, but it seems as if physicians kind of all along the spectrum of disease severity are interested.

Okay, great. And very last part of my question is regarding RELA, you know, with the potential of being used in combination with other therapies like immunotherapy, as you mentioned before, or ABCs in the future, any specific concerns overlapping toxicities over here?

I'm going to give you to Bill Geyer.

Yeah, thank you for that question. No, there are absolutely no concerns of overlapping toxicities. We look to see, again, to be the agent of choice in combination with any immunotherapy or chemotherapy, and we will do that in many future studies to come to prove that.

And there really is no mechanistic reason to think that there would be that problem. It looks like we're out of questions. Thank you very much for everybody who has called in. We look forward to really what's next. It is, you know, I really do view this personally. It's an exceptionally exciting time. We really have an opportunity to help many, many people, and you'll be a part of it. So thank you very much, and we'll talk to you next quarter.

This concludes today's conference call. Thank you for participating. You may now disconnect.