This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk13: Good day and thank you for standing by. Welcome to the Course of Therapeutics conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. And to ask a question during the session, you will need to press star 1 on your telephone keypad. And please be advised that today's conference is being recorded. Should you require further assistance, you may press star 0. And I will now turn the call over to Mr. Atabak Mukari, CFO. Please go ahead.
spk03: Good afternoon, and thank you for joining us. I'm Adivac Mukari, Corset's Chief Financial Officer. Today, we issued a press release announcing our financial results for the first quarter and providing a corporate update. The copy is available at corset.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 at the Investors Past Events tab of our website. Statements during this call, other than statements of historical fact, are forward-looking statements based on our plans and expectations that are subject to risks and uncertainties, which may 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 states. Our revenue in the first quarter was $93.7 million, an increase of 18% compared to the first quarter of last year. As a reminder, each year, insurance reauthorization and coverage of our portion of the donor whole gap and Medicare Part D coverage reduce our first quarter revenues. We expect our revenue growth to continue and have reiterated our 2022 revenue guidance of $400 to $430 million. Net income was $22.8 million or 20 cents per share in the first quarter, and our cash and investments increased $32 million in the first quarter to $368.1 million at March 31st. I will now turn the call over to Charlie Robb, our Chief Business Officer, provide an update on our litigation with generic manufacturers Teva and Hicklund Pharmaceuticals. Charlie?
spk04: Thanks, Adivac. There's little to report this quarter. As many of you know, Teva is seeking to market a generic version of Coraline in violation of our patents. In March 2018, we sued Teva in federal district court. That litigation is still underway. In the midst of our federal court litigation, TEVA launched a parallel challenge to the validity of one of our patents, the 214 patent, in a procedure before the Patent Trial and Appeals Board, or PTAB, known as a Post-Grant Review, or PGR. In November of 2020, the PTAB rejected TEVA's arguments, upholding the 214 patent in its entirety. TEVA appealed its loss to the Federal Circuit Court of Appeals, where, in December of 2021, it lost again. The matter is closed. Having lost the PGR, TEVA can no longer challenge the 214 patent's validity in our district court case. TEVA can only argue that its proposed product would not infringe a position we believe has no legal or factual support. A year ago, we filed for summary judgment based on TEVA's infringement of the 214 patent. TEVA responded by filing its own summary judgment motion. Summary judgment is a procedure whereby courts can decide a case without holding a trial. We believe the court has all it needs with respect to the 214 patent to decide the case in our favor, in which case Teva would be barred from marketing generic corulum until 2037 when the 214 patent expires. If the court rules in Teva's favor, we will proceed to trial, most probably sometime next year, although it is impossible to say with certainty. There's no timetable for the summary judgment ruling, no trial date, and no schedule for any trial-related activities. All is quiet. which is in some respects unfortunate. This case has gone extremely well for us, and we would like to wrap things up. In March 2021, we sued another antifiler, Hikma Pharmaceuticals, in the same federal district court that is hearing our case against Teva. In this case, the court has set a fact discovery deadline of July 1 this year. Nothing is scheduled after that. With respect to both Teva and Hikma, we are very confident in the strength of our legal position. I will now turn the call over to Dr. Joseph Belanoff, our Chief Executive Officer. Joe?
spk11: Thank you, Charlie. While we are getting closer to resuming our pre-pandemic way of life, some of the challenges posed by the pandemic persist. Even though recent COVID cases have tended to be mild, public health precautions taken by patients, physicians, and our commercial team have made it more challenging for physicians to identify, diagnose, and optimally treat all of their patients. and especially those with a complex disorder such as Cushing syndrome. Hopefully, these challenges will be completely behind us very soon. Despite residual effects of the pandemic, I want to stress how optimistic we are about the present and future of our Cushing syndrome business. This business is built on a strong foundation, an effective, life-saving medication promoted by a dedicated commercial team that puts the interests of patients first. Leading endocrinologists increasingly believe that there are substantially more patients with Cushing syndrome than was once assumed. For many of these patients, Coraline is an excellent treatment. As pandemic conditions and fears recede, we expect our growth to continue, and we are reiterating our 2022 revenue guidance of $400 to $430 million. We are also extremely optimistic about our clinical development. We have said for years that cortisol modulation has the potential to help treat many serious diseases. The data generated by our ovarian cancer program provides evidence of cortisol modulation's broad application. In 2022, we will see important results for many of our other ongoing clinical programs. These programs are examining the lead candidates from our portfolio of more than 1,000 proprietary cortisol modulators. many of which are attractive candidates for development. Like corallum, these compounds bind strongly to the glucocorticoid receptor or GR. Unlike corallum, they have no affinity for the progesterone receptor and so don't cause some of corallum's most serious off-target effects. Beyond sharing the qualities of strong cortisol modulation and not perturbing the progesterone receptor, Preclinical and clinical testing have shown that our molecules behave differently from one another in important ways. Some cross the blood-brain barrier. Others do not. Some perform best in models of solid tumor. Others are more potent in models of metabolic disease. Some appear to be tissue-specific. Others have more global effects. These diverse qualities have allowed us to initiate clinical trials in a wide variety of disorders. including ovarian, adrenal, and prostate cancer, antipsychotic-induced weight gain, NASH, and, of course, Cushing syndrome. We plan to start a Phase II trial in patients with ALS early next quarter and have additional compounds in Phase I and preclinical development. Corlum's commercial success has provided the funds to advance all of these programs and will continue to do so. Our oncology program is testing three anti-cancer mechanisms, first postulated by investigators at the University of Chicago and confirmed by other prominent researchers. One mechanism is increasing apoptosis, the program cell death that chemotherapy is meant to induce in solid tumors. Cortisol suppresses apoptosis, meaning cortisol works against the beneficial effect of chemotherapy. In our successful trial in women with advanced ovarian cancer, the addition of our selective cortisol modulator reliquarolent enhanced the effect of chemotherapy, likely by blunting cortisol's anti-apoptotic effect. While these patients' disease had progressed on two or more previous lines of treatment, reliquarolent appeared to resensitize some of these patients to the beneficial effects of chemotherapy. As a reminder, our Phase II trial was a controlled, multicenter study of 178 women with platinum-resistant ovarian cancer who were randomized to one of three treatment arms. Sixty women received a higher dose of relacoralin on the day before, the day of, and the day after they received napaclitaxel. We call this the intermittent arm. Fifty-eight women received a lower daily relacoralin dose in combination with napaclitaxel. We call this the continuous arm. And 60 women received nabpaclitaxel alone. We call this the comparator arm. The trial's primary endpoint was progression-free survival, or PFS. The women who participated in our study were very ill, and including those with platinum refractory disease. All had experienced disease progression despite prior lines of therapy. All but one had progressed on prior courses of taxane-based therapies. Their median number of prior treatments was three. We presented the results from the study at the September 2021 European Society for Medical Oncology ESMO Congress and provided an update at our investor event in March. As these results clearly showed, relacoralin provide benefits to many of these women. Those who received relacoralin intermittently exhibited a statistically significant improvement in PFS compared to the group that received napaclitaxel monotherapy. The hazard ratio in this group was 0.66 with a p-value of 0.038. The women in the intermittent arm also experienced a statistically significant improvement in duration of response relative to those in the comparator arm with a hazard ratio of 0.36 and a p-value of 0.006. The women in the intermittent relacoralin group also lived longer. The hazard ratio for this group was 0.67 with a p-value of 0.066. Their median survival, or OS, for this group was 13.9 months, 1.7 months longer than for the napaclitaxel monotherapy group, which was 12.2 months. Importantly, safety and tolerability data for the women treated with relacoralin plus napaclitaxel was comparable to those who received napaclitaxel alone. We will share these results in an oral presentation at the American Society of Clinical Oncology, ASCO, annual meeting on June 6th in Chicago. Based on these positive results, we and our investigators are excited to conduct a phase three trial. Our phase three trial design is very similar to the design of our phase two trial with some standard modifications. For example, as is typical of late stage clinical trials, our phase three trial will exclude patients with either primary platinum refractory disease, patients who sadly never respond at all to the standard platinum drug therapy, and those who have already received four or more prior lines of therapy. Excluding such patients from the phase two trial results produced an even greater differential improvement in progression-free survival, duration of response, and overall survival. Women in the intermittent arm Experienced a statistically significant improvement in progression-free survival with a hazard ratio of 0.58 and a p-value of 0.016. Duration of response with a hazard ratio of 0.26 and a p-value of 0.001. And overall survival with a hazard ratio of 0.52 and a p-value of 0.01 relative to patients who received napaclitaxel alone. We have received very positive feedback from leading gynecologic oncologists regarding the promise of relacoralin as a treatment for women with this desired disease. In their view, relacoralin's potential benefit, improved survival without increased side effect burden, would constitute an important medical advance. They feel that the relacoralin plus nabpaclitaxel has the potential to become a new standard of care in ovarian cancer. We have designed and will conduct our Phase III trial with advice from two leading research groups, the Gynecologic Oncology Group in the United States and the European Network of Gynecological Oncology Trials Group in Europe. Most of our investigators will be drawn from these groups. We and members of the Gynecologic Oncology Group will meet with the FDA in June to discuss the optimal path forward and will initiate our Phase III trial shortly thereafter. 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 metastatic prostate cancer treated with the widely prescribed androgen receptor antagonist enzalutamide eventually experience resurgent disease. Deprived of androgen stimulation, their tumors switch to cortisol activities to stimulate growth. Our hypothesis is that adding a cortisol modulator to androgen deprivation therapy will close this tumor escape route. We recently completed enrollment in our dose-binding study of our selected cortisol modulator hexacorrelant combined with enzalutamide in men with castrate-resistant prostate cancer. Investigators at the University of Chicago are conducting a similar study of relacorrelant combined with enzalutamide in the same patient population. We expect to select an optimum dose of either relacorrelant or hexacorrelant to take forward this quarter. A third mechanism seeks to reduce cortisol suppression of the immune system, a quality of cortisol that likely blunts the effectiveness of immunotherapy. We are conducting an open-label Phase 1B trial of brelicoralin plus the PD-1 checkpoint inhibitor pembrolizumab, Merck's drug Keytruda, in patients with advanced adrenal cancer whose tumors produce excess cortisol. These patients suffer the effects of adrenal cancer and Cushing syndrome, a usual quickly lethal combination. Pembrolizumab is rarely effective as monotherapy in these patients. We believe that these patients' cortisol excess may be countering the intended effects of pembrolizumab, which is to stimulate the immune system. Our trial is evaluating whether reliquorolin can treat these patients' Cushing syndrome by reducing excess cortisol activity, and by reversing cortisol-induced immune suppression, allow pembrolizumab to achieve its full cancer-killing effects. We plan to enroll 20 patients at seven sites in the United States. The primary endpoint of this study is objective response rate, with secondary endpoints including progression-free survival, duration of response, and overall survival. I'll now turn to our programs in metabolic disease and the recent findings of our selective cortisol modulator, Miracorrelant. in patients with NASH, a serious liver disorder. Patients who received miracoralin in our Phase II trial exhibited large, rapid reductions in liver fat, but also substantial transient elevations of the liver enzymes ALT and AST. The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected and are rarely seen over any period of treatment. As a reminder, our trial's primary endpoint was a 30% reduction in liver fat after 12 weeks of treatment. In fact, patients exhibited reductions ranging from 38.5% to 73.8% after receiving miracoralin for just a month. It may be that the rapidity of miracoralin's fat-reducing effect caused the patient's ALT and AST to rise. One way the liver sheds fat is by metabolizing it into fatty acids. which in excessive amounts irritate the liver. Interestingly, lipids in the blood of these patients did not increase, providing support for the idea that meroprolent caused their excess fat to be metabolized immediately within the liver. The goal of our Phase 1b dose-finding trial in patients with presumed NASH is to identify a dosing regimen that significantly reduces fat without causing excessive liver irritation. We're also evaluating miracoralin as a potential treatment for patients with another serious and widespread disorder, antipsychotic-induced weight gain. In the United States, 6 million people take antipsychotic medications, such as olanzapine and risperidone, to treat illnesses including schizophrenia, bipolar disorder, and depression. While these drugs are very effective, they exact a steep price in the form of rapid and sustained weight gain, leads to cardiovascular and metabolic disease. The average life expectancy of patients in the United States who chronically take antipsychotic medication is decreased by 20 years, frequently due to increased cardiovascular effects, such as heart attacks and strokes. We are conducting two double-blind placebo-controlled Phase II trials of miracluralin in patients with this disorder, gratitude and gratitude II. both of which I'm pleased to say are now fully enrolled. These trials seek to build on the positive data from our study of miracoralin in healthy subjects. In 2020, we completed a trial in which 96 healthy subjects received olanzapine and either 600 milligrams of miracoralin, 900 milligrams of miracoralin, or placebo for 14 days. Subjects who received miracoralin gained significantly less weight than those who received placebo. They also exhibited a smaller increase in triglycerides and in ALT and in AST, which typically exhibit sharp transient increases at the start of olanzapine therapy. A paper describing these results was published in the Journal of Clinical Psychopharmacology. The GRATITUDE trial is evaluating whether miracoralin can reverse recent Patients with schizophrenia or bipolar disorder receive, in addition to their established dose of antipsychotic medication, either 600 milligrams of miracoralin or placebo for 12 weeks. Gratitude is being conducted at 30 centers in the United States. Our Gratitude II study is testing miracoralin as a treatment for longstanding antipsychotic-induced weight gain. Patients with schizophrenia will receive, in addition to their established dose of antipsychotic medication, either 600 milligrams or 900 milligrams of miracoralin or placebo for 26 weeks. Gratitude II is being conducted at 35 centers in the United States. The primary endpoint in both studies is reduction in body weight. Other important measures of metabolic activity will also be examined. We look forward to the data readouts from these trials in the fourth quarter. If the results are positive, we plan to advance our program to phase three next year. As most of you know, relacoralin is our planned successor to coralum for the treatment of hypercortisolism. We are evaluating it in two phase three trials, GRACE and GRADIENT. Like all of our proprietary molecules, relacoralin is a selective cortisol modulator. Like coralline, it achieves its effect by competing with cortisol at the glucocorticoid receptor. Unlike coralline, it does not bind to the progesterone receptor, PR for short. It is not the abortion pill, and it does not cause other PR-related side effects, including endometrial thickening and vaginal bleeding. By a different mechanism, relacoralline also does not appear to cause hypokalemia, low potassium. a serious side effect experienced by 44% of patients in Coraline's pivotal trial. Coraline-induced hypokalemia is a leading cause of Coraline discontinuation. Relacoraline's Phase II efficacy and safety data were strong. 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 relacoralin-induced instances of endometrial thickening or vaginal bleeding, and no drug-induced hypokalemia. The trial results were published in Frontiers in Endocrinology. Our GRACE trial has a planned enrollment of 130 patients with any etiology of Cushing syndrome. As a reminder, GRACE has a randomized withdrawal trial design. All patients receive relacoralin for 22 weeks in an open-label phase. Those who meet response criteria for improvement in glucose control, hypertension, or both are randomized to continue treatment with relacoralin or placebo for 12 weeks. While the pandemic had a real impact on the execution of this trial, we and our investigators are eager to take Grace to the finish line. We expect Grace to serve as the basis for our NDA submission in Cushing syndrome, which we now expect to submit in the second half of 2023. Our second phase three trial, Gradient, is studying relic-correlant effects in patients whose Cushing syndrome is caused by an adrenal adenoma or adrenal hyperplasia. Patients with this etiology of Cushing syndrome often experience a less rapid decline, but ultimately their health outcomes are poor. Gradient has a planned enrollment of 130 patients and is being conducted at many of the sites participating in GRACE. Gradient is the first controlled study in patients with this type of Cushing syndrome. While we do not expect our NDA in Cushing syndrome to depend on data from gradient, we do expect that its findings will help improve the care of these increasingly recognized patients. Finally, a brief word about data to correlate, which has shown great promise in animal models of ALS. We are on track to initiate a phase two trial early next quarter. This study is being shepherded by TRICALS, the leading ALS academic consortium in Europe. We will have more to say as that trial gets underway. We expect our commercial growth to continue as pandemic conditions recede. Remember, even in the most challenging periods of the pandemic, our commercial business generated more than enough cash to fund our advancing development activities. We believe cortisol modulation can help treat many serious disorders. I believe for which our development programs are now providing a growing body of evidence. Coraline and relacoraline for patients with Cushing syndrome provide an easy-to-see example of cortisol modulation's benefit. The data generated by our ovarian cancer program provides a good example of cortisol modulation's broad application. 2022 opened with strong overall survival results in our Phase II trial of adjunctive rilocoralin in platinum-resistant ovarian cancer. The remainder of 2022 will provide results from other important programs in our cortisol modulation portfolio, in particular, NASH and antipsychotic-induced weight gain. Both are following up on extensive preclinical and encouraging early clinical results. We are also excited to start a phase two trial using another of our proprietary compounds, dazocoralin, to treat patients with ALS. Last, but not least important, additional proprietary compounds are advancing towards the clinic. This is an exciting time at Corset. I'd like to thank our employees for their tremendous effort and dedication. We recently announced three key additions to our commercial and development leadership and are expanding our teams more broadly to support what we believe is an incredibly broad and strong pipeline and a substantial commercial opportunity. I'll stop here for questions.
spk13: Thank you, presenters. At this time, for the participants, you may press star 1 on your telephone keypad. And if you would like to withdraw your question, you may press the pound key. We will pause for just a moment to compile the Q&A roster. We have our first question from Matt Kaplan from Leidenberg. Please go ahead.
spk07: Hi. Congrats on the quarter. Strong results. Thanks, Matt. I just wanted to focus a little bit on reliquarolent and Cushing's and the GRACE and gradient studies. Given your new guidance, how should we think about how long it should take to prepare an NDA to file in the second half of of 23, is that roughly a six-month process or something like that?
spk11: Well, just to introduce an important voice in the room, I'd like to reintroduce you to Bill Geyers, who's our Chief Development Officer, to take that question. Let me rest my voice for a little bit.
spk02: Go ahead, Bill. Thank you for that question. Since we're planning for an NDA in the second half of 2023, Approximately four to six months prior to that, we should have completed the study and then allow us to prepare for that NDA.
spk07: Okay. Okay. That's helpful. And in terms of gradient, how is that progressing in terms of enrollment?
spk02: Gradient study is enrolling in parallel to that of grace, so very similarly.
spk07: Okay. So kind of on a parallel path.
spk02: On a parallel path, yes.
spk07: And, um, and then in, in terms of, uh, the, uh, your, your metabolic program, uh, metabolic disease, um, program, uh, is, is, is, um, in terms of the phase two data for both of the, uh, both of the studies that are expected in the second half of this year and the fourth quarter, um, what, what, what would you need to see to, to get excited there to, uh, to move into phase three in 23. In terms of antipsychotic weight gain.
spk02: Antipsychotic weight gain, yeah. There are many patients with antipsychotic-induced weight gain, and this is the first time that we've ever done this important experiment. We're gonna see a lot of data from both of these trials and learn a lot after we've analyzed the data to determine their implications. As we learn from this data set, we're gonna primarily focus, as Joe said earlier, on evaluation of weight changes for miracorrelant at the different doses versus that of placebo, as well as other metabolic factors that we're going to be evaluating in the study compared to that of placebo. And so it's that collection of overall data set of weight changes and metabolic factors that will really help guide us forward on the next steps forward of how to proceed to phase three next year.
spk07: Okay, great. Well, thanks for taking the questions.
spk13: We have our next question from Chris Howerton from Jefferies. Please go ahead.
spk09: Great. Thanks so much for taking the questions. I think maybe I'll start with thinking about the revenue guidance that you provided this year. Relative to the first quarter performance, you're going to have to have the best three quarters that you've ever had in order to meet those guidance. what gives you the confidence that you'll be able to achieve that?
spk11: Yeah, no, I understand the question. And, again, I'd like to reintroduce you to Sean Maduke, who is the president of our endocrinology division.
spk01: Yeah, thanks for the question, Chris. And I want to just sort of reiterate what was said in the comments and what Joe had said previously, that we are reiterating our guidance and believe we remain on track for that. the first quarter in particular. There's a couple of things that occurred in that. There's the expected and then the unexpected. The expected, Ottobock mentioned in his opening remarks, I mean, every January we see challenges in the areas of insurance three-offs and donut hole gap coverage. And we make sure that treatment's not interrupted for patients. We provide free drug until that paid coverage resumes. And that leads to more free drug, but not fewer patients on medicine. So I'd say that's the expected piece of it. The unexpected piece that affected us in Q1 was was increased COVID concerns. So in Q4 and then the first half of Q1, the Omicron surge created disruption to our business, some disruption. I would say practices were closed again like they were earlier in the year, and it was hard for our clinical specialists to get in, and patients were also hesitant to actually go and see their doctors, which is necessary for appropriate screening and testing. And in addition to that, the first time during this COVID window, our team was affected. Multiple members of our field force actually caught the virus and had to be out of the field, which limited their time in seeing physicians. So I've talked about this in the past, but it takes many interactions with a clinical specialist before a physician goes from prescribing their first prescription. And the lag effect of both the Omicron surge and the limited field time had an impact on our Q1. So, you know, all that being said, Omicron came and it went pretty quickly, and things are really starting to return to normal, and we're optimistic that improvement is going to continue through 2022, which is why we feel confident in the next three quarters.
spk11: Yeah, and just, Chris, you know, because I do want to emphasize, and your math is absolutely correct. In order to meet our revenue guidance, we have to have the best cores that we've ever had, and that is our expectation.
spk09: Okay. I mean, that's awesome. Okay. And then if I may, on the ovarian cancer phase three trial, I could totally have this wrong, but my understanding is that experimental agents in combination need to be studied separately first. And I guess... What are your expectations of how the FDA is going to treat nabpaclitaxel, given that it doesn't have a label in ovarian cancer going into that study?
spk02: Thank you for that question. This is Bill Geyer. So when it comes to nabpaclitaxel, there is a wealth of research that has gone along with nabpaclitaxel in ovarian cancer. So with that package, I think that helps us, since this isn't just the first time we've ever studied it, we're adding to that body of The other key piece is those who have done the studies with napaklitaxel primarily were the gynecological oncology organization, the GOG. And they are the people who we partnered with to help us with the FDA. And they have a wealth of experience in working with the FDA to shepherd drugs through phase three, but also to get drugs approved through the FDA. So we feel very confident that what we've designed in our trial will move forward very expeditiously. In addition, And we're going to be talking with the FDA this quarter. And so we will seek their guidance, some very shortly. But we still plan to initiate the phase three study this quarter.
spk09: Okay. All right. Well, thanks so much. And then I guess, if I may, if you'll let me on the last one for the GRACE trial, I think point taken in terms of the COVID impacts on enrollment, but I actually can't remember what the sites were. Is there any impact of the unfortunate war conflict that we're having on enrollment, or would there be any impact of loss to follow-up potential?
spk11: Yeah, you know, it's interesting, Chris. You're the first person to ask that question, and it's a good question, you know, because we actually, I can tell you at the beginning of the study, had actually considered having sites in Ukraine and just, you know, I guess in hindsight. Luckily, did not have that there to sort of add to all the problems that exist in that country. So far, we really haven't seen that as much of an issue. Last week, we were at a very well-attended investigator meeting in Europe, and we didn't really hear any feedback about that being a problem at all. So I'm going to say no, it has not. But, you know, of course, the future over there is far less certain than we'd like it to be. But no, at this point, no issue, and we certainly would talk about it if there became an issue.
spk09: Awesome. Okay. All right. Well, thanks for all the answers to my questions, and congratulations on the progress so far.
spk11: You're welcome, Chris. Thank you.
spk13: We have our next question from Edward Nash from Canaccord Genuity. Please go ahead.
spk08: Hi. Hi. Hi, guys. Thanks for taking my question. I hope you guys are doing well. What are the states that have been in the updates in the New Jersey AG investigation? Have they requested anything beyond the original inquiry to date? I'm going to turn you back over to Charlie Robb.
spk04: Okay. Hi, Ed. So the answer is that the nature of these investigations generally is that they start with initial list of stuff, and there's sort of some fluid back and forth, but I really have nothing to announce about that investigation right now. But I think that maybe the more interesting thing I can say is that I regret having nothing to announce about the investigation so far. Let me just provide a little bit of context so you can understand why I'm saying that, which is that for those who don't follow this as closely, what Ed's referring to is a a request for information that we received from the DOJ, a subpoena back in November of last year. As we announced then in our doing, we said we would cooperate with their inquiry, which we're certainly doing, and our approach is to provide them with the information that they want as fast as we can and always faster than they're able to absorb. And why is that? The reason is we really want to stay ahead of them. We want them to always have information from us to review because that's the way you move things along as expeditiously as possible. I mean, their inquiry, although, you know, not directly causally linked in any way, but is in some ways sort of the culmination of these sort of short-seller allegations that turned into a class action lawsuit that we're litigating now. And now we have this DOJ inquiry. And the reason I welcome speed and expeditious resolution in that case is the DOJ is staffed by public servants who are interested in the truth. And the truth for us is our friend. And so I want to get our story in front of them as fast as we possibly can because I think that is how we will put this all behind us happily and be able to move forward without this distraction. So I wish there was something to say. There will be something to say in the future, but right now there's really nothing to add.
spk08: That's great. No, I appreciate that detail. And then just my last question is just regarding miracorrelant and antipsychotic-induced weight gain. So how do you think about patient characteristics of those with recent versus longstanding weight gain? I mean, are there any differences in metabolic parameters between each group? Do you think the patient's With longstanding, AWIG have achieved homeostasis with regard to metabolic parameters after weight gain, and does that impact your thoughts on the potential duration of treatment for the patients versus recent AWIG?
spk11: Yeah, it's a very good question. I haven't gotten that one either, but really it's an opportunity for me to talk a little bit about it. Patients who take antipsychotic medications, and I can tell you as someone who prescribes them, tend to gain weight very quickly, and it is often very difficult for them to lose it no matter what they do over time. And yet they have to take their antipsychotic medication. You know, as I sort of think about patients with schizophrenia, you know, sort of ruthlessly say the worst thing a patient with schizophrenia can do is not take their medication and And the second worst thing they can do is take their medication because these medications really do cause serious, serious metabolic problems. And yet for the purposes, which are very good at reducing psychosis, they're quite effective. So we're doing the study. You know, I know no one's ever done in some sense either of these two studies, which is can you reduce the weight gain caused by antipsychotic medication at all? And sort of the early study are people who you can really track to the very beginning when they began their antipsychotic medication. It's within the last six months. Can you actually take away that weight gain? Or take a look at the other group of which the numbers in the United States are really ample of patients who have taken antipsychotic medication for a long time, and have substantial weight gain, but are potentially a little less specific to the antipsychotic medication because they've lived their life in America, an American diet, and so on and so forth. So I don't know what the results of these studies are going to be. Obviously, I have a hypothesis that our medicine will be beneficial for both of those groups. But as Bill mentioned before, much data come. And it's going to be very, very interesting both for us and for the field to see if we can really do something about this problem, whether it's a short-term problem or a long-term problem. It's a big problem. And I really look forward to seeing the, you know, turning over the cards in these blinded studies.
spk08: Great. Thanks so much. Really appreciate the color there. Look forward to a strong next three quarters. Thank you. Thank you.
spk13: We have our next question from Greg Frazier from Truist Securities. Please go ahead.
spk12: Hey, thanks. Good afternoon, folks. I'm not sure if I missed this, but on grades, did you comment on how many patients have been enrolled so far?
spk02: No, I did not comment on the number of patients enrolled so far. You know, we don't typically comment on the number of patients that are totally enrolled, but I will give you some commentary on them. Coming out of the pandemic, March was our best enrolled to date of this trial. So we're seeing good progress coming out of the pandemic.
spk11: Yeah, that's just not a metric we report, Greg.
spk12: Yep, understood. SG&A spend stepped up in the quarter. Were there any temporary drivers of the higher spend in Q1, or is that level sort of a new normal from which they'll grow?
spk03: Adelbach? Sure. Hey, Greg. As we talked about, we've expanded our teams, and that's a big driver of it. There are some temporary things like legal expenses, but for the most part, I think of that as our go-forward expense.
spk12: Got it. Okay. And then you have a number of academic collaborators that are conducting studies of cortisol modulators in different settings, like alcohol use disorder, epilepsy. Do you anticipate getting data from any of those studies this year? If you could just lay out what you might learn and when from those activities, that would be helpful. Thank you.
spk11: Yeah, this is really like a watershed day. I love talking about this stuff. No one ever asked me about it, so you got me started. We have, at any given point, including today, about 35 different academic collaborations of people who are using cortisol modulators. about half in the United States, half outside of the United States, about half preclinical and half clinical. And now to answer your question, yes, I do think that some of these studies will produce results this year. But just remember, they're not our studies. They belong to the clinical investigators or the academic investigators who are doing them. I can tell you just as a broad statement, yes, you will see results from some of those studies this year. I do know where they are, particularly one which referring to, which is the Relacor-1 study in prostate cancer. You know, that will be relatively soon. But there are others. I am, and you mentioned it, very, very interested in seeing the study results in the alcohol use disorder study, which is being done at Scripps. So fingers crossed. I'm as anxious to see those results as you are, and there's a broad range of them. So stay tuned.
spk12: Thanks for taking the questions.
spk13: We have our next question from Arthur from HC Wainwright. Please go ahead.
spk05: Hey, gentlemen. This is Arthur in for RK. Most of my questions have been answered. I just want to follow up on the mesh study. Could you guys give us an update on the enrollment status for this study, and how many of those levels have been tested so far, and when could we expect the initial clinical data from the study? Thank you.
spk02: Well, thank you for that question. I really can't comment on the progress on each cohort. All I will tell you is the strategy is moving forward very well with great screening and great enrollment activities for all of the different cohorts. Since this is an open-label trial, we're evaluating data for each patient and each cohort as it progresses. And the plan is to finish this trial and all the cohorts this year.
spk05: Awesome. Thank you.
spk11: Thank you, Arthur.
spk13: We have our next question from Taizin Hamad. Please go ahead and please state your company name.
spk10: Hey, this is Leon Wang for Tuzin. Just a quick question. In terms of some of the legal expenses that you mentioned as an OpEx driver in OneQ, can you get some more color on that? I mean, is this from IP or ANDA, or is this some other kind of legal expense that you are incurring?
spk04: No, it's nothing new. You know, we're at the stage of, you know, we're producing information for the DOJ. Class action lawsuit happens to be kind of in the same calendar phase. So, you know, you get enough people charging you by the hour in a room looking through documents and doing email queries, and you can really rack up a bill. And that's what's going on here. But once, you know, that's sort of a bolus of expense that we just have to work through and You know, that's what you're seeing this quarter. Can't, you know, can't comment on future quarters that much because, you know, it's always a little bit unpredictable how these things go. But you're seeing that this quarter for sure.
spk10: Okay, gotcha. So just for this quarter, you're expecting this more bolus of a quarter versus maybe perhaps some future quarters coming up.
spk04: Yeah, I mean, we will get through this set of expenses, and that's all I can really say about it with any certainty.
spk10: All right, thank you.
spk13: We have our next question from Alan Leong from Bayou Watch New. Please go ahead.
spk06: Hey, thanks for taking my questions, and Joe, it's good to hear from you again.
spk12: Yeah, hi, Alan.
spk06: I ask a couple of different questions. I wanted to bring back an OD. I want to ask about the FKBP5 mRNA expression test for GI receptor activities. Do you still like what you see? And assuming all goes well, do you aim to market the test with a reliquaryland commercial launch?
spk11: Yeah. Thank you for that question, Alan. Just to I know how closely you follow, but just for the rest of the listeners, one of the things that we're really very interested in working on is seeing if we can come up with a more accurate test for cortisol activity than exists at the current time. In fact, there really are no tests for cortisol activity at this time. Only cortisol level is mentioned. And Alan, again, I just say this for the whole audience. You may be aware of it, but we have now published the results from surgical and post-surgical study of FKBP5 in patients with Cushing's disease. Now, you know, it was peer-reviewed in a very strong journal. But the most important thing to tell you is we collect that information, the FKBP5 changes, in all the studies that we do. And so we think it's very important. We'll see where that shakes out. Certainly an experiment, but it would be a terrific experiment because one of the things that any clinician will tell you is that Patients can have severe Cushing syndrome with moderate levels of cortisol excess and moderate Cushing syndrome with extraordinarily high levels of cortisol excess. It doesn't really match up so well. Our hope is that this measure will match up more accurately and be very useful to physicians. Will it be ready at the time that the reliquaryland NDA is submitted? I doubt it. I think it's going to actually post-date that. But, you know, if you want to cross your fingers and assume that the results are good, I'm hoping it won't be too much behind that. So, you know, it's not going to be, if the question was, is it going to be part of what's needed for the NDA for reliquaryland and Cushing syndrome, it is not. It really is its own finding should it come to pass.
spk06: How has the phase went for quart 1, 2, 5, 3, 2, 9? Was it what you hoped, or is it just something that's put to rest for now?
spk11: You know, Alan, again, I appreciate your understanding of all the detail we're in. Hazel Hunt, who is our really fantastic medicinal chemist and came up with all of these compounds, you know, has several compounds, you know, both preclinical and in clinical, I can tell you 1, 2, 5, 3, 2, 9, just you can file it away somewhere, is a potent glucocorticoid receptor modulator. Where we take it, uncertain at this point in time because, you know, as I commented on before, after we find out that it really is the modulator that we hope it to be, we then begin other biological assays to see where it can be best placed. Is it best in oncology? Is it best in metabolic diseases, and that's actually taking place right now.
spk06: Thank you. Looking forward to your next quarter.
spk11: Yeah, nice to talk to you again, Alan. I think this concludes all the people who had questions, so thank you very much for all the detail. We'll obviously release information as we have it, and we'll talk to you about three months from now.
spk13: Ladies and gentlemen, this concludes today's presentation. Thank you for participating. You may now disconnect.
Disclaimer