Greetings, and welcome to the Corcept 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 one on your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host, Atabak Mokari, CFO. Thank you. You may now begin.
Good afternoon. Thank you for joining us. I'm Atabak Mokari, Corcept's Chief Financial Officer. Today, we've issued a press release announcing our financial results for the fourth quarter and providing a corporate update. A copy is available at corcept.com. Our completed 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 investors at 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 expressed or implied.
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. Our 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 million-$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 2021. Our cash and investments at December thirty-first 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. Charlie?
Thanks, Atabak. 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 Melucci versus Corcept Therapeutics Incorporated. 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 Corcept and the way we do business. Allegations such as those asserted in the Melucci lawsuit are repugnant.
We had looked forward-- We had looked forward to our day in court when we can explain publicly the reasons for our pride in what we do and the way we do it. 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 Melucci distraction behind us for an amount covered by our insurance, we felt compelled to accept. The second terminated case concerned Sigma Pharmaceuticals. In March 2021, we sued Sigma to prevent it from marketing generic Korlym in violation of our patents. As we announced in December, we have settled this case.
Sigma may begin selling a generic version of Korlym 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 Korlym in violation of our patents. In April 2021, we filed for summary judgment based on Teva's infringement of our '214 patent. Teva, as expected, responded 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 and ordered the parties to begin negotiating a schedule for pre-trial 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'll now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?
Thank you, Charlie. Our Cushing's 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's syndrome than was once assumed. Korlym is an excellent treatment for patients with Cushing's syndrome, and there are many eligible patients who have yet to receive it.
We are extremely optimistic about the growth potential of our Cushing's 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-$450 million. In addition to generating substantial cash in 2022, we significantly advanced the clinical development programs of our proprietary selected cortisol modulators, relacorilant, dazucorilant, and miricorilant. We expect to make further progress in the next 12 months with the submission of relacorilant's NDA in Cushing's syndrome and enrollment of our confirmatory phase III trial of relacorilant in platinum-resistant ovarian cancer, phase II trial of dazucorilant in ALS, and phase II trial of miricorilant 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 or GR. They do not bind to the progesterone receptor, so don't cause some of Korlym's, our approved products, more 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's syndrome. We are investigating cortisol modulation's role in other diseases and have additional compounds in clinical and pre-clinical development. Our Cushing's syndrome business is funding all of these activities and will continue to do so. As most of you know, we are evaluating relacorilant for the treatment of hypercortisolism in two phase III trials, GRACE and GRADIENT. Relacorilant is a selective cortisol modulator. Like Korlym, it achieves its effects by competing with cortisol at the glucocorticoid receptor.
Unlike Korlym, 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, relacorilant also does not appear to cause hypokalemia, low potassium, a serious side effect experienced by 44% of patients in Korlym's pivotal trial. Korlym-induced hypokalemia is a leading cause of Korlym discontinuation. Relacorilant'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 relacorilant-induced instances of endometrial thickening or vaginal bleeding and no drug-induced hypokalemia. 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 in 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's syndrome, which we plan to submit in the first quarter of 2024. Our second phase III trial in hypercortisolism, GRADIENT, is studying relacorilant's effects in patients whose Cushing's syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing's syndrome often experience a less rapid decline, but their health outcomes are poorer.
While we do not expect our NDA in Cushing's 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 phase II study of Korlym 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 Korlym. 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 programmed 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 II trial in women with platinum-resistant ovarian cancer, the addition of our selective cortisol modulator, relacorilant, enhanced the effect of chemotherapy, likely by blunting cortisol's anti-apoptotic effect. Relacorilant 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, relacorilant appeared to resensitize the disease to chemotherapy's beneficial effects in some women.
Those who received relacorilant intermittently, the day before, the day of, and the day after they received nab-paclitaxel, exhibited a statistically significant improvement in progression-free survival and duration of response compared to the group who received nab-paclitaxel monotherapy. Women in the intermittent relacorilant group also lived longer than those in the comparator arm with a P value that approached statistical significance. Our analysis to date indicates that 29% of the patients who took intermittent relacorilant were alive two years after study start, versus only 14% who took nab-paclitaxel alone. 13% of patients who took intermittent relacorilant are alive three years after study from study start, compared to none who took nab-paclitaxel alone.
Perhaps even more important, the women who received relacorilant plus nab-paclitaxel experienced no additional side effect burden compared to those who received nab-paclitaxel 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 achieve either relacorilant plus nab-paclitaxel or nab-paclitaxel 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 Gynecologic Oncology Group in the United States and the European Network for Gynaecological Oncological Trial groups in Europe. Our goal in phase III is simply to replicate our positive phase II results. Leading gynecological oncologists have told us that in their view, relacorilant's potential benefit, improved survival without increased side effect burden, would constitute an important medical advance.
Relacorilant plus nab-paclitaxel has the potential to become a new standard of care in women with platinum-resistant ovarian cancer. A second mechanism by which cortisol modulation can 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 antagonists and 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 collaboration with the University of Chicago plans to begin a randomized placebo-controlled phase II trial of relacorilant plus enzalutamide in patients with prostate cancer before 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 relacorilant plus 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's syndrome, a usually quickly lethal combination. Pembrolizumab is rarely effective in treating this form of adrenal cancer. Our trial is evaluating whether relacorilant can treat the patient's Cushing's 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. DAZALS, our 198-patient randomized double-blind placebo-controlled phase II trial of dazucorilant in patients with ALS, has begun enrolling patients. Dazucorilant 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.
I'll turn to our program in NASH, a serious liver disorder that afflicts millions of patients in the United States. Miricorilant, an oral medication, continues to demonstrate great promise as a treatment for NASH. In our prior NASH study, patients who received miricorilant exhibited large, rapid reductions in liver fat, but also substantial albeit 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'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 appear 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's 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's 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. In addition to relacorilant, dazucorilant, and miricorilant, we have many other cortisol modulators in our portfolio with potentially different and valuable clinical attributes. Corcept Therapeutics continues to advance across multiple fronts.
I thank our dedicated creative employees and loyal investors for making this possible. I'll stop here for questions.
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 one from your telephone keypad and a confirmation tone to indicate your line is in the question queue. You may press star two 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, while we pull for questions. Thank you. Thank you. Our first question is from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.
Hi, guys. This is Raymond in for Matt. Thank you for taking our question today. Congrats on all the progress. I just wanted to ask, perhaps on the ALS program, specifically or kind of what endpoints are you kinda looking for in the study? Is it ALS FRS? Do you have any specific guidance from the FDA if this study could serve as the basis for an NDA filing? Thanks. I have one more question. Thank you.
Yes. Yes, Matt. I wanted to reintroduce you to Bill Guyer, who is our Chief Development Officer. Bill will address that question.
Great. Thank you. appreciate the question. Again, DAZALS is a phase II home instead of randomized double-blind placebo-controlled trial, evaluating the safety and efficacy of dazucorilant in patients with ALS. In this phase II trial, we're gonna look at 198 patients. The primary endpoint is a 24-week endpoint, where we're gonna be evaluating those patients related to placebo. We're gonna 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 dazucorilant in patients with ALS. These are all validated endpoints with the FDA. If we complete this trial, and we see positive results, this could end up with an NDA.
Yeah, cool. Appreciate the color. I guess, maybe just for the NASH program, what would you like to see from the phase 1b that is kind of increasing confidence as you enter the phase II study? Is it possible you would try multiple dosing regimens? Thanks.
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. 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. Hopefully we see ALT improvements. We believe we've identified multiple doses or dosing regimens to move into phase II, where we've seen that progressive fat loss over time and no ALT rises. Yes, our plan is to move to phase II in the fourth quarter of this year.
Okay, appreciate that. Guys, I'll hop back into you.
Our next question is from the line of Dennis Ding with Jefferies. Please choose your questions.
Hi, guys. Thanks for taking my questions. I just have one 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? You know, perhaps what are some of the different assumptions for you know, to get there? 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.
Good. Thank you. Thank you for those questions. I want to again reintroduce you to Sean Maduck, who is the President of Corcept Endocrinology, and Sean is responsible for all of our business in Cushing's syndrome. He'll be glad to answer that question.
Hey, Dennis. Thank you for the question. I think your question was directly in regards to 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. Where we fall within the range is really driven by the number of patients that we add to our base. That's the pushes and the pulls are constant. It's really about patient counts.
Right. As a follow-up, maybe talk about what can you do or what you, what are you guys doing, you know, in terms of initiatives that are ongoing that could drive more patient adds versus, drive less patient adds, appreciating that there's you know, competition out there?
Yeah, no, great question. Look, I'll start by just saying the evidence is clear that there are more hypercortisol 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 gonna be diagnosed and treated. Our job as an organization is just to maximize our physician touchpoints, continue to raise disease awareness, educate on screening, and then educate on the benefits of Korlym. 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 wanna 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's syndrome in their patient population has increased substantially. 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 was just discussed, and that's the CATALYST study, the phase IV Korlym study that we announced on the call today. It's not gonna have an impact in 2023, it's the largest perspective 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. We believe that patients with difficult to control diabetes and is a very rich patient population for hypercortisolism. I believe that this study will provide the definitive prevalence to treatment data needed to encourage increased screening and ultimately treatment for this patient group.
Got it. Thanks. Then on the seasonality question, for Q1 and the re-acceleration towards the back half of the year.
Yeah. We always see a dip in the, in the first quarter, because of insurance reauthorizations and the donut hole, this year is no different than any other. Yeah, I guess that's all I would add there. 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 Korlym, but for all medications, particularly orphan drug medications, is that insurance companies make decisions to get a reauthorization at the beginning of the year. That's obviously our job to see if we can help those get turned around as quickly as possible. You know, 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 Korlym for Cushing's syndrome, they get the medication regardless of whether or not they have insurance.
They continue to get that medication. We never leave the patient off of that medication. Getting them back on a paid insurance that they had before is in some sense, you know, a new rate that occurs every year. The quicker we do that, the more it connects back to first quarter revenues. Once that's in place, we're on our arc for the rest of the year.
Got it. Thank you.
Sure.
The next question is from the line of Greg Fraser with Truist. Please proceed with your question.
Good afternoon, folks. Thanks for taking the question. I got on a little late, I apologize if you've covered this already. 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. I'm curious about it. It seems like it's a study that a lot of it is quite large and, you know, it's unprecedented. It seems like a study that could potentially capture patients that would otherwise be started on Korlym. I know the study will be run by docs that you're not calling on, it sounds like. Could this create a headwind for new starts on Korlym, or am I thinking about that the wrong way?
Hey, Greg, just sort of sorting this out. I wanna give the first part to Bill, who's conducting the study. Bill can answer the questions about protocol and so forth.
Yeah. CATALYST is an example, you know, that I think we are showing our continued investment in our compounds, whether approved or investigational. The CATALYST, as Sean had mentioned, is the largest study of its kind, where we're gonna be testing two really rigorous important points. One is to understand the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes. The second is to understand the efficacy and safety of Korlym in these patients. In that patient population, we're gonna be looking at 1,000 patients, and where we're gonna be simply testing them for hypercortisolism with a simple DST. From there, we're gonna be then evaluating them. For those who are positive, will 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. 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, exclusion criteria of this study. 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 have 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. 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 on this next month in March and complete enrollment of this trial by the end of this year.
The second part of the question, Greg, I have to give you to Sean.
Yeah. Thank you. The question was whether or not this study will impact potentially Korlym patients that would have been on Korlym previously. The answer to that is no. Remember, this is a group of physicians. Not only are they not prescribing Korlym today, they're not even aware that these hypercortisolism patients exist in their practice. They are treating these patients for their diabetes and aren't aware. 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 aren't treating or diagnosing.
Got it. 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 investment that you're making on the commercial side and also on the clinical side with the CATALYST study?
Sure, Greg. It's not a lot. 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. On the SG&A side, you know, Sean discussed the continued investments we're making on the commercial side there. You'll see some increases on both sides there.
Got it. Okay. The last question, I just wanted to ask about the recent of the class action settlement. 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?
Yeah, sure. Just the brief background for those who, you know, haven't followed the story. We've been in this, you know, defending the class action or purported class action lawsuit since 2018, so quite some time. You know, 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. 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. Had the opportunity recently to settle it.
When I said that litigation is a distraction from more important matters, I really hope that everyone will really take that on board. Imagine you had a day where you could spend your time, you know, helping to move a drug, promising drug candidate through, say, the regulatory process or development process, or you could review a giant stack of emails from three years ago. That's really the difference between settling and not settling. We chose to settle when we had an opportunity to do so on advantageous terms. 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 their 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. You know, one never can tell. One thing I can say for sure is that we're very, very confident in our legal position with respect to them. That's what the Melucci 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.
My understanding is that generally speaking, the Department of Justice does pay attention to what happens, as you would imagine, in sort of, they're not loosely related, but sort of parallel civil cases. There's no actual legal connection between the Department of Justice action or inquiry and the Melucci class action, they probably have their eye on it. I don't know what they're thinking because they don't and wouldn't tell me, obviously. 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. I hope that's the impression they take away from it and that that colors their thinking.
Of course, I cannot be sure. That inquiry proceeds, and we'll just have to see how that plays out. We're very comfortable with respect to that inquiry also.
Great. Thanks for taking the questions.
Our next question is from the line of Arthur He with H.C. Wainwright. Please proceed with your question.
Hey, good afternoon, gentlemen. This is Arthur on for RK. Thanks for taking my question. First one is regarding the Cushing's business. Could you give us some color from your perspective there about the in-person clinical interactions, in the second and fourth quarter, and also what is the first quarter this year?
Yeah, no, thanks for the question. The question was, what are the in-person interactions in the fourth quarter of last year into this year? You know, in the past, we've discussed sort of some of the obstacles that we faced because of COVID restrictions. I'll tell you that sort of 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 inaccessible physicians closed their doors to industry during the pandemic, and I believe that some of those will keep restrictions in place permanently.
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. We've seen some success in that.
Awesome. Thanks for the color. Regarding the ovarian cancer study, could you give us more color on the enrollment status? How many sites are active for now?
Bill Guyer here, I'll give you some color around there. Well, I won't give you exact metrics on it 'cause we don't really talk about metrics, but I'll give you more color. You know, momentum has continued, it's tracking to expectations for our ovarian cancer phase III trial. We expect to fully enroll this trial by the end of this year. We believe that because we've got great collaborators like the GOG, which is the Gynecologic Oncology Group here in the United States, and ENGOT, which is the European Network of Gynaecological Oncology Trial Group. Those groups are helping us get enrolled in number of sites that we need, and we've determined we need about 125 sites globally.
Of those sites, we've had an investigator meeting within 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 relacorilant that could be used in combination with nab-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. We're then seeing the same and having the same excitement of relacorilant plus nab-paclitaxel for the women in their practice. We expect very positive things, now and moving forward with this trial.
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 the capital allocation? Thanks.
Yeah. Arthur, thank you. Thank you everyone, for all of your questions. Look, we have a cash-producing business as we have for many, many years. You know, the exciting thing is we have very good things at Corcept in which to invest in. Our clinical programs are advancing. As you know, as they succeed in going to later-stage studies, the programs become more extensive too. Of course, you know, success is a good thing. We're very glad to spend money in that way. We're really always taking a, you know, careful look at what, you know, where our money goes. You know, 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 Corcept. We will proceed in that way. If anything changes, I will let you know, of course. I wanna thank all of you for tuning in this quarter. Hopefully big progress coming in the next three months, and we'll both seeing you at that point in time.
Good rest of the week. Thank you.
This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.