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spk05: Greetings and welcome to the CoreSep Therapeutics conference call. At this time all participants are in listen-only mode. The question and answer session will follow the formal presentation. If you'd like to register to ask a question, please press star 1 on your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. If anyone should require operator assistance during the conference, please press star 0 from your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Adibak Mokari, CFO. Thank you. You may now begin.
spk07: Good afternoon, and thank you for joining us. I'm Adibak Mokari, Corsup's Chief Financial Officer. Today, we issued a press release announcing our financial results for the fourth quarter and providing a corporate update. A copy is available at Corsup.com. Our complete financial results will be available when we file our Form 10-K with the SEC. Today's call is being recorded. A replay will be available at the Investors Past Events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subjects to risks and uncertainties, which might cause actual results to differ materially from those such statements express or imply. These forward-looking statements are described in today's press release, and the risks and uncertainties that may affect them are described in the press release and in our annual report on Form 10-K and our quarterly reports on Form 10-Q. Please refer to those documents for additional information. We disclaim any intention or duty to update forward-looking statements. The revenue in the fourth quarter of 2022 was $103.1 million. compared to $98.8 million in the fourth quarter of 2021. We expect our revenue growth to continue and have provided 2023 revenue guidance of $430 to $450 million compared to 2022 revenue of $401.9 million. Net income was $16.6 million in the fourth quarter and $101.4 million for the full year 2022. Our cash and investments at December 31st was $436.6 million, compared to $335.8 million at the end of the prior year. I will now turn the call over to Charlie Robb, our Chief Business Officer, to provide a legal update.
spk04: Charlie? Thanks, Adabak. Since we last spoke, we have successfully terminated two lawsuits. On February 13th, we announced that we had reached an agreement in principle settling all claims in the purported securities class action known as Malucci v. Gorsuch Therapeutics, Inc. This lawsuit was brought by plaintiff's attorneys in March 2019. Since then, our position has not wavered. We said in March 2019 that we were confident in the strength of our legal position. Having spent four years litigating, we are even more confident. I, and I know I speak for my colleagues as well, am proud of Corecept and the way we do business. Allegations such as those asserted in the Malucci lawsuit are repugnant. We had looked forward to our day in court where we could explain publicly the reasons for our pride in what we do and the way we do it. That being said, litigation is a distraction from more important matters. Simply put, Time spent preparing for trial is time not spent developing medications or helping patients. When presented with the chance to put the Malucci distraction behind us for an amount covered by our insurance, we felt compelled to accept. The second terminated case concerns Hikma Pharmaceuticals. In March 2021, we sued Hikma to prevent it from marketing generic core element violation of our patents. As we announced in December, we have settled this case. HITMA may begin selling a generic version of Coraline in the United States beginning October 1st, 2034, more than 11 years from now, or earlier under circumstances customary for settlement agreements of this type. This is the same entry date as our previous settlement with Sun Pharmaceuticals. Finally, there was a development yesterday in our lawsuit against Teva. In March 2018, we sued Teva to prevent it from marketing a generic version of Coraline in violation of our patents. In April 2021, we filed for summary judgment based on Teva's infringement of our 214 patent. Teva is expected to respond by filing its own motion for summary judgment. Summary judgment is a procedure whereby courts decide a case without holding a trial. Yesterday, the court denied both our motion and Teva's motion without prejudice in order for the parties to begin negotiating a schedule for pretrial activities. No trial date has been set. It is important to note that this change in the procedural posture of our action against Teva has not changed our point of view. We remain confident in the strength of our legal position and are very comfortable proceeding to trial if necessary. I now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?
spk08: Thank you, Charlie. Our Cushing Syndrome business is built on a solid foundation. a life-saving medication promoted by a commercial team that puts the interests of patients first. Leading endocrinologists increasingly believe that there are considerably more patients with Cushing syndrome than was once assumed. Quorum is an excellent treatment for patients with Cushing syndrome, and there are many eligible patients who have yet to receive it. We are extremely optimistic about the growth potential of our Cushing syndrome business and are making substantial investments to improve the screening and treatment of these patients. We are providing... 2023 revenue guidance of $430 million to $450 million. In addition to generating substantial cash in 2022, we significantly advanced the clinical development programs for proprietary selective cortisol modulators, relacoralin, dasucoralin, and miracoralin. We expect to make further progress in the next 12 months with the submission of relacoralin's NDA in Cushing syndrome, an enrollment of our confirmatory phase 3 trial of relacoralin in platinum-resistant ovarian cancer, phase 2 trial of dasacoralin in ALS, and phase 2 trial of miracoralin in NASH. Since inception, our research and development efforts have built upon the hypothesis that cortisol modulation can be a powerful therapeutic mechanism in many serious disorders. Our proprietary compounds modulate cortisol's effects by binding to the glucocorticoid receptor, They do not bind to the progesterone receptor, so don't cause some of chlorolones, our approved products, with serious off-target effects. Interestingly, while our compounds modulate cortisol's activity without modulating progesterone's activity, they are not identical. 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. Others have more global effects. These diverse qualities allow us to study a wide variety of disorders. Currently, we are conducting programs in ovarian, adrenal, and prostate cancer, ALS, NASH, and, of course, Cushing syndrome. We are investigating cortisol modulation's role in other diseases and of additional compounds in clinical and preclinical development. Our Cushing syndrome business has funded all of these activities and will continue to do so. As most of you know, we are evaluating relacoralin for the treatment of hypercortisolism in two phase three trials, GRACE and GRADIENT. Relacoralin is a selective cortisol modulator. Like corallin, it achieves its effects by competing with cortisol at the glucocorticoid receptor. Unlike corallin, it does not bind to the progesterone receptor, PR for short, and so does not cause PR-related side effects, including termination of pregnancy, endometrial thickening, and vaginal bleeding. By a different mechanism, relacoralin also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in coralline's pivotal trial. Coralline-induced hypokalemia is a leading cause of coralline discontinuation. Relacoralin's Phase II efficacy and safety data were compelling. Patients experienced meaningful improvements in hypertension and glucose control, as well as in a variety of other signs and symptoms of Cushing's syndrome. There were no reliquary-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced typokalemia. The trial results were published in Frontiers in Endocrinology in July 2021. We are pleased to announce that we believe that we have enough patients and screening in our GRACE trial to complete enrollment in the coming weeks. We expect GRACE to serve as the basis for our NDA submission in Cushing syndrome, which we plan to submit in the first quarter of 2024. Our second phase 3 trial in hypercortisolism, GRADIENT, is studying relacoralin's 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 their health outcomes are poor. While we do not expect our NDA in Cushing syndrome to depend on data from GRADIENT, we do expect that its findings will improve the care of these patients. Finally, we plan to initiate a randomized, double-blind, placebo-controlled, base-course study with Corla in this quarter. We have named the study Catalyst. Catalyst will examine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and treat the patients determined to have hypercortisolism with Corla. Planned enrollment is 1,000 patients, which we expect to complete by the end of this year. The most prominent diabetologists in the country helped design and are participating in this study. Our oncology program is testing three anti-cancer mechanisms, first postulated by investigators at the University of Chicago and later confirmed by other prominent researchers. One mechanism is increasing apoptosis, the program's cell death that chemotherapy is meant to induce in solid tumors. Cortisol works against the beneficial effect of chemotherapy by suppressing apoptosis. In our successful controlled phase 2 trial in women with platinum-resistant ovarian cancer, the addition of our selective cortisol modulator, relacoralin, enhanced the effect of chemotherapy, likely by blending cortisol's anti-apoptotic effect. Relacoralin provided meaningful benefit to many of the women in our study, While these women's disease had progressed on two or more previous lines of treatment, including previous taxanes, relacorin appeared to resensitize the disease to chemotherapy's beneficial effects in some women. Those who received relacorin intermittently, the day before, the day of, and the day after they received napaclitaxel, exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received napaclitaxel monotherapy. Women in the intermittent reliquaryland group also live longer than those in the comparator arm, with a p-value that approaches statistical significance. Our analysis to date indicates that 29% of the patients who took intermittent reliquaryland were alive two years after study start, versus only 14% who took nap haplotaxel alone. 13% of patients who took intermittent reliquaryland are alive three years after study start, compared to none who took napaclitaxel alone. Perhaps even more important, the women who received relucoralin plus napaclitaxel experienced no additional side effect burden compared to those who received napaclitaxel alone. The results from the study were featured in podium presentations at the 2021 and 2022 European Society for Medical Oncology, ESMO, meetings, and at the 2022 American Society of Clinical Oncology, ASCO, annual meeting. Rosella, our pivotal Phase III trial in platinum-resistant ovarian cancer, is active in enrolling patients. Rosella's design closely tracks our Phase II study with planned enrollment of 360 women, randomized one-to-one to receive either relacorlin plus napaklitaxel or napaklitaxel alone. The primary endpoint will be progression-free survival, with overall survival a key secondary endpoint. We are conducting the study in collaboration with leading clinicians from the Gynecological Oncology Group in the United States and the European Network of Gynecological Oncology Trials Group in Europe. Our goal in Phase 3 is simply to replicate our positive Phase 2 results. Leading gynecological oncologists have told us that, in their view, Relicoralin's potential benefit improves survival without increased side effect burden would constitute an important medical advance, and norelacoralin plus napaclitaxel has the potential to become a new standard of care in women with platinum-resistant ovarian cancer. A second mechanism by which cortisol modulation may prove useful is by blocking an important tumor growth pathway. 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 hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. By mid-year, our collaborators at the University of Chicago plan to begin a randomized placebo-controlled phase 2 trial of relacoralin plus enzalutamide in patients with prostate cancer. these patients have had an initial prostatectomy. A third therapeutic mechanism seeks to treat tumors by enhancing the body's immune response. Cortisol suppresses the immune system, which may blunt the effectiveness of cancer therapies intended to stimulate the immune system. Our hypothesis is that adding a cortisol modulator to immunotherapies, such as checkpoint inhibitors, may enhance the effectiveness of these therapies. We are conducting a phase 1B trial of relaflorid plus PD-1 checkpoint inhibitor, hembrolizumab, 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. Hembrolizumab is rarely effective in treating this form of adrenal cancer. Our trial is evaluating whether relacoralin can treat these patients' Cushing syndrome by reducing excess cortisol and by reversing cortisol-induced immune suppression, allow pembrolizumab to achieve its full cancer-killing effect. The primary endpoint of this study is objective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival. ALS, commonly known as Lou Gehrig's disease, is a devastating illness with an urgent need for better treatment. DASLs, our 198-patient randomized double-blind placebo-controlled phase 2 trial of dazocoralin in patients with ALS, has begun enrolling patients. Dazocoralin is a selective cortisol modulator that has shown great promise in animal models of ALS, improving motor performance and reducing neural inflammation and muscular atrophy. We are conducting this important study in collaboration with TRICALS, the leading ALS academic consortium in Europe. Finally, I'll turn to our program in NASH, a serious liver disorder that afflicts millions of patients in the United States. Mirocorrelant, an oral medication, continues to demonstrate great promise as a treatment for NASH. In our prior NASH study, patients who received miracoralin exhibited large, rapid reductions in liver fat, but also substantial, albeit transient, elevations of the liver enzymes ALT and ASC. The improvement in liver fat in these patients was greater, and it cut much more rapidly than we'd expected, and is rarely seen over any period of treatment. Our Phase 1b dose-finding study has identified a range of doses all substantially lower than our originally tested doses, that appeared to cause substantial reductions in liver fat without causing excessive liver irritation. We expect to share results from this study by mid-year and plan to start a Phase II trial later this year. In conclusion, we are extremely optimistic about the growth potential of our Cushing syndrome business and are making significant investments to improve the screening and treatment of these patients. In the meantime, the business continues to generate substantial profits, even after funding all of our development programs. Our development programs continue to generate evidence validating our long-held belief that cortisol modulation has the potential to treat a wide range of diseases. Reducing cortisol activity is a straightforward and effective way to treat Cushing syndrome. It is also clear that cortisol modulation can offer substantial benefits for many other serious disorders. Ovarian cancer, ALS, and NASH are prime examples, but there will be others. And in addition to relacoralin, dasacoralin, and miracoralin, we have many other cortisol modulators in our portfolio with potentially different and valuable clinical attributes. CORSAP continues to advance across multiple fronts. Thank our dedicated creative employees and loyal investors for making this possible. I'll stop here for questions.
spk05: Thank you. At this time, we'll now be conducting the question and answer session. If you'd like to register a question at this time, please press star 1 from your telephone keypad, and the confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys One moment, please, so we poll for questions. Thank you. Thank you, and our first question is from the line of Matt Kaplan with Leidenberg Salmon. Please refuse your question.
spk02: Hi, guys. This is Raymond from Matt. Thanks for taking our question today. Congrats on all the progress. I just wanted to ask, perhaps on the ALS program, specifically, what endpoints are you kind of looking for in the study? Is it ALS, FRS? And do you have any specific guidance from the FDA if this study could serve as the basis for an NDA pilot? Thanks. And I have one more question. Thank you.
spk08: Yes. Yes, Matt. I want to just reintroduce you to Bill Guyer, who is our chief development officer.
spk07: Bill will address that question. Great. Thank you. Appreciate the question. So, again, dazzling design. phase two multi-center randomized double lung placebo controlled trial, evaluating the safety and efficacy of Dazacorlin in patients with ALS. In this phase two trial, we're going to look at 198 patients. The primary endpoint is a 24-week endpoint where we're going to be evaluating those patients related to placebo. And we're going to look at the efficacy and change from baseline for the ALS functional rating scale. And that is a validated FDA endpoint, as well as other primary endpoints of safety to assess the safety and efficacy or the safety of DAS-correlated patients with ALS. These are all validated endpoints with the FDA. And if we complete this trial and we see positive results, this could end up with an NDA.
spk02: Cool. Appreciate that, Colin. And I guess maybe just for the NASH program, what would you like to see from the Phase 1B study to kind of increase your confidence as you enter the Phase 2 study? And is it possible you would try multiple dosing regimens? Thanks.
spk07: Yeah, that is the goal. That's a great question. Since this is an open-label trial, we're evaluating all the various different doses, and our goal has been to find the right dose or dosing regimen where we get a progressive fat loss over time with then no ALT rises, and hopefully we see ALT improvements. We believe we've identified multiple doses or dosing regimens to move into Phase 2. where we've seen that progressive BAT loss over time and no ALT rises. And so, yes, our plan is to move to phase two in the fourth quarter of this year.
spk02: Appreciate that. Thanks. I'll hop back in the queue.
spk05: Our next question is from the line of dentistry. It's Jeffrey's. Please receive your questions.
spk01: Hi, guys. Thanks for taking my questions. I just have one question. around the base business. Maybe talk about the pushes and pulls on 2023 revenue in terms of what can get you towards the high end versus the low end of your guidance. And, you know, perhaps what are some of the different assumptions for you, you know, to get there. And as a follow-up, maybe remind us of the seasonality issue for Q1 and when might we get better visibility towards growth acceleration in 2023. Thank you.
spk08: Good, Dan. Thank you. Thank you for those questions. I want to, again, reintroduce you to Sean Madu, who is the president of the Render Chronology Division. And Sean is responsible for all of our business in Cushing Syndrome. We'll be glad to answer that.
spk09: Hey, Dennis. Thank you for the question. I think your question was directly in regards to sort of the range. Our range is driven by the number of patients that we add to our active patient base. Our pricing is known, and our average dose and patient retention rates have been stable for many years. So where we fall within the range is really driven by the number of patients that we add to our base. And the pushes and the pulls are constant. It's really about patient
spk01: Right, but as a follow-up, maybe talk about what can you do or what are you guys doing, you know, in terms of initiatives that are ongoing that could drive more patient ads versus drive less patient ads, appreciating that there's, you know, competition out there.
spk09: Yeah, no, great question. So, look, I'll start by just saying the evidence is clear that there are more hypercortisone patients out there than we once thought. Physicians, as they become more educated about screening and about treatment options, that are available to them, more patients are going to be diagnosed and treated. And our job as an organization is to maximize our position touchpoints, continue to raise disease awareness, educate on screening, and then educate on the benefits of Coraline. And the evolving market and our execution will really drive that growth into 2023 and beyond. You know, in terms of initiatives, obviously we have many going on, but there's a couple I want to touch on that I think are very important for the organization. The first is the growth of our sales force. Last year, we had 45 clinical specialists. We currently have 55 going to 60 in the next couple of months. Physician awareness of the potential for Cushing syndrome in their patient population has increased substantially. And we think that that disease awareness and our streamlined training efforts will make our clinical specialists more productive and for our newest clinical specialists more productive more rapidly. In terms of the second initiative, which is more long-term, is what study that we announced on the call today. It's not going to have an impact in 2023, but it's the largest prospective study that's ever been done in this patient population. As Joe stated, the investigators are a very prominent group of diabetologists, and they are representative of a group of physicians that we have not historically called on. So we believe that patients with difficult-to-control diabetes is a very rich patient population for hypercortisolism, and I believe that this study will provide the definitive prevalence and treatment data needed to encourage increased screening and ultimately treatment for this patient group.
spk01: Got it. Thanks. And then on the seasonality question for Q1 and the growth reacceleration towards the back half of the year,
spk09: Yeah, so we always see a hit in the first quarter because of insurance reauthorizations and the donut hole. This year has been no different than any other. But, yeah, I guess that's all I would add there.
spk08: I don't know if there's anything else, Joe, you'd like to add? You know, Dennis, I really do understand what you're asking about. Yeah, as Sean said, one of the issues, not just for Corlin, medications is that insurance companies make decisions to get a reauthorization at the beginning of the year. And it's obviously our job to see if we can help those get turned around as quickly as possible. One of the things I'll just point out is that it's been our philosophy from the beginning of the company that any time a patient gets a prescription for Crohn's or Cushing's syndrome, they get the medication regardless of whether or not they have insurance. but getting them back on paid insurance as they have before is, in some sense, a maneuver that occurs every year. And the quicker we do that, the more it adds back to first-point revenues. And then once that's in place, we're on our arc for the rest of the year. Got it. Thank you.
spk01: Sure.
spk05: Our next question is from the line of Greg Fraser with Truist. Please proceed with your question. Good afternoon, folks.
spk06: Thanks for taking the questions. I got on a little late, so I apologize if you covered this already, but I was hoping you could comment on the protocol for the catalyst study and talk about the enrollment criteria, the types of patients that'll be enrolled. And I'm curious about it. It seems like it's a study that, well, obviously it's quite large and it's unprecedented. It seems like a study that could potentially capture patients that would otherwise be started on Coraline. I know the study will be run by docs that you're not calling on, it sounds like. But could this create a headwind for new starts on corallum, or am I thinking about that the wrong way?
spk08: Hey, Greg, just sort of sorting this out, I want to give the first part to Bill, whose group is conducting the study. So Bill can answer the questions about protocol and so forth.
spk07: Yeah, so Catalyst is an example that I think we are showing our continued investment in our compounds, whether approved or investigational, and And the catalyst, as Sean had mentioned, is the largest study of its kind, where we're going to be testing two really rigorous, important points. One is to understand the prevalence of hypercorporealism in patients with difficult-to-control type 2 diabetes. And the second is to understand the efficacy and safety of corlemin in these patients. And in that patient population, we're going to be looking at 1,000 patients, and we're going to be simply testing them for hypercorporealism with a simple DST. And from there, we're going to be then evaluating them. And for those who are positive, we'll then be selected to and have a choice to go into the second part of the study, which is that treatment part of the study. As Sean had also previously mentioned, we're working with the top diabetologists. And while this is a large study, these diabetologists have thousands of patients in their practice and have already identified many of them who could meet the inclusion and exclusion criteria of this study. And when you look at that inclusion and exclusion criteria, I'll give you a few points there. It's for adult patients who are age 18 to 80, those who are difficult to control diabetes, and that's defined simply by having a hemoglobin A1C of greater than 7.5, but less than 11.5, and are taking multiple antihyperglycemic drugs. plus many other things, but that's the simple design of the trial of how to get in. We believe by working with these top diabetologists that we've designed a trial that's easy to enroll and we're on track to start the trial next month in March and complete enrollment of this trial by the end of this year.
spk09: Second part of the question, Greg, I'm happy to give you to Sean. Yeah, thank you. And the question was whether or not this study will impact, you know, potentially, coralline patients that would have been on coralline previously? The answer to that is no. Remember, this is a group of physicians. Not only are they not prescribing coralline today, they're not even aware that these hypercortisols in patients exist in their practice. They are treating these patients for their diabetes and aren't aware. So again, I'll go back to what I said a moment ago, is that That's the hope of this study is that that will provide definitive prevalence in treatment data that will help, I'll say, sway and motivate this group of physicians who currently are in treating or diagnosed.
spk06: That's very helpful. Thank you. Can you help with how to think about the growth for SG&A and R&D this year, given the investments that you're making on the commercial side and also on the clinical side with the catalyst studies?
spk07: Sure. Craig, it's Adelbach. I'll take that one. We have, as you know, we've historically been profitable and plan to remain profitable. Our R&D expenses will increase as we invest in our development programs and our investment programs advance. And on the SG&A side, you know, Sean discussed the continued investments we're making on the commercial side there. So you'll see some increases on both sides there.
spk06: Got it. Okay. My last question, I just wanted to ask about the recent, you recently had the class action settlement. I'm curious about what you think that might mean, if anything, for the other civil cases that are pending. and also for the DOJ investigation. Thank you. Charlie?
spk04: Yeah, sure. So just the brief background for those who haven't followed the story. You know, we've been in this, you know, defendant in a class action or purported class action lawsuit since 2018, so quite some time. And, you know, we, over time as we, you know, prepared for trial someday in the distant future. You know, we started off confident in our position and confident in the way we were doing business, and we really only got more so as things developed and as we, you know, got all of our ducks in a row and really reviewed all of the possible evidence. We just felt better and better, but had the opportunity recently to settle it, because when I said that Litigation is a distraction for more important matters. I really hope that everyone will really take that on board. And imagine you had a day where you could spend your time helping to move a promising drug candidate through, say, the regulatory process or the development process, or you could review a giant stack of emails from three years ago. And that's really the difference between settling and not settling. So we chose to settle when we had an opportunity to do so on advantageous terms. Now, what you're referring to are there are a handful of sort of associated civil cases brought by plaintiffs, law firms, sort of around the country. They think of these as sort of like the pilot fish that attach themselves to sharks as they move through the ocean and try to survive off the food that escapes from the shark's mouth. That's what these lawsuits are like. And there are a handful of them. We will dispose of those one way or the other shortly following this is my expectation, but one never can tell. But one thing I can say for sure is that we're very, very confident in our legal position with respect to them. So that's what the Malucci securities class action portends for those ancillary cases. I think with respect to the Department of Justice, of course, I have no idea what the attorneys at the Department of Justice are thinking. However, my understanding is that, generally speaking, the Department of Justice does pay attention to what happens, as you would imagine, in sort of, not loosely related, but sort of parallel civil cases. There's no actual legal connection between the Department of Justice action, our inquiry, and the Maluji class action, but they probably have their eye on it. And I don't know what they're thinking because they don't and wouldn't tell me, obviously. But I hope what they see is what we see, which is a settlement on very advantageous terms for the company, which reflects the sort of the confidence that we have in the way we do business. So I hope that's the impression they take away from it and that that colors their thinking. But of course, I cannot be sure. And that inquiry proceeds, and we'll just have to see how that plays out. We are very comfortable with respect to that inquiry also.
spk06: Great. Thanks for taking the questions.
spk05: Our next question is from the line of Arthur Heath with H.E. Wainwright. Please proceed with your question.
spk03: Hey, good afternoon, gentlemen. This is Arthur for Arcade. Thanks for taking my question. So first one is regarding the cushion business. Could you give us some color from your perspective there about the in-person clinical interactions in the first quarter and also what you see in the first quarter this year?
spk09: Yeah, no, thanks for the question. The question was, what are the in-person interactions in the fourth quarter of last year and into this year? And in the past, we've discussed some of the obstacles that we face because of COVID restrictions. And I'll tell you that through the fourth quarter and today, our in-person interactions are at about 80 to 90% of pre-COVID levels. And we expect that to be our new baseline. Some previously accessible physicians closed their doors to industry during the pandemic. And I believe that Some of those will keep restrictions in place permanently. So we're utilizing alternative means as a company to get in front of these physicians, whether it be virtual meetings, digital marketing, and educational programs to try to make up some of that gap, and we've seen some success in that.
spk03: Awesome. Thanks for the color. And so regarding the ovarian cancer study, could you give us more color on enrollment status and the So far, how many sites are active for now?
spk07: I'll give you some color around there. Well, I won't give you exact metrics. We don't really talk about metrics, but I'll give you more color. You know, momentum has continued, and it's tracking to expectations for our ovarian cancer phase three trial. We expect to fully enroll this trial by the end of this year. And we believe that because we've got great collaborators like the GOG, which is the gynecological oncology group here in the United States, and NGOT, which is the European Network of Gynecological Oncology Trial Group. Those groups are helping us get enrolled in a number of sites that we need, and we've determined we need about 125 sites globally. And of those sites, we've had an investigator meeting in the United States, and it was probably the most positive investigator meeting we've ever had, where we talked about all of the data, and the investigators in the U.S. came away with the excitement and the benefit that they saw for reliquary that can be used in combination with that paclitaxel. Next week, we're having an investigator meeting in Europe with all of the top investigators. I think there's about 50 investigators attending that investigator meeting, and we expect to see the same result of them seeing the same and having the same excitement of reliquarylet plus nabpaclitaxel for the women in their practice. So we expect very positive things now and moving forward with this trial.
spk03: Thanks so much for the color. My last question is, again, regarding your capital allocation strategy with decent amount of cash. Do you guys have any idea on their capital allocation? Thanks.
spk08: Yeah, Arthur, thank you, and thank you to everyone for all of your questions. Look, we have a cash-producing business, as we have for many, many years. And so, you know, the exciting thing is we have very good things at Corecept in which to invest in. Our clinical programs are advancing, and as you know, as they succeed and go into later stage studies, the programs become more expensive. glad to spend money in that way. And so we're really always taking a careful look at where our money goes. It's not a secret. We get solicited all the time from earnest investment bankers who have things that they would like us to invest in. We, of course, take a careful look at that. But at this point, we really believe that the best thing for us to invest in is the business that we're doing in Corset. And so we will proceed in that way. If anything changes, I will let you know if And so I want to thank all of you for tuning in this quarter. Hopefully big progress in the next three months and look forward to seeing you at that point in time. So good rest of the week. Thank you. This will conclude today's conference.
spk05: You may disconnect your lines this time. Thank you for your participation.
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