Corcept Therapeutics Inc

NASDAQ:CORT

Earnings Call Transcript 2020-Q3

[Operator]

[00:00:00] Good day and welcome to the Corcept Therapeutics conference call, today's call is being recorded to signal for questions today, please press star one. And at this time, I'd like to turn the call over to Charlie. Rob. Please go ahead.

[Charlie Robb, Chief Financial Officer]

[00:00:14] Thank you. Good afternoon, everyone. I'm chief financial officer. Today, we issued a press release announcing an increase for the first quarter and writing a corporate update copy is available at first dotcom. Complete results will be available for our content team and the FTC, they call it being recorded. A replay will be available November 17th, Twenty twenty at one 888 two zero three one one one two eight and one seven one nine four five seven zero eight two zero. International passcode six eight zero zero seven zero six figures during this call. As a statement of historical fact, our statement, based on our plans and expectations, are subject to risks and uncertainties which may cause actual results to differ materially in such statements. Express or why? These risks and uncertainties include our ability to our ability to operate our business and keep our goal of maintaining pandemic and thereafter including our ability to generate revenue and cash reserves sufficient in our commercial operations, development programs and the availability, of course, in exchange for accommodation or buildings in any crisis or adequate insurance coverage and reimbursement for and risks related to the development of our product. Candidates, including clinical and regulatory approval mandates, oversight and other requirements. And these activities, like the pandemic on our employees, consult with vendors as well as physicians, patients, insurers, regulators in practice, medicine generally. These and other risks are set forth and are asking people to curveball at our Web site and the FTC Web site and this call for the debate statements include those concerning our revenue, cash flow and expected growth.

[00:02:09] Our stock repurchase program and independent sources that the government pandemic, our commercial operations, financial performance and government programs, physicians and patients, and expectations regarding a financial performance, including the government program after the campaign and border control vision, awareness of all from Portland to be affected by the treatment, timing and the lawsuits against San Pharmaceuticals, and then to challenge the validity of one of our past for the patent trial and appeal for the power of our intellectual property. The benefit of our designation progress, enrollment time in line, the results of our clinical trials, and the clinical and commercial activities from Pensacola, Florida, and other selected football players to play in any information or duties for. Ready for the third quarter? Eighty six point three percent increase in the third quarter, 2019, third quarter and at twenty one point six million dollars and twenty six point four percent in the same period last year, excluding non-cash expenses related to stock based compensation and utilization for tax related income tax effects, none that had income. The third quarter was thirty million dollars, compared to thirty seven point eight million dollars in the third quarter. We keep our cash in investment to forty four point two dollars million in the thirty three point seventy one dollars for the consideration of our strong financial position. Prospects of directors a the program running through September 30th twenty twenty one to repurchase up to two hundred million dollars for our common stock. And we've been trying to find any signs of any differences based on market conditions, our stock price and other factors we believe relative to you can grow together with that gasoline will be sufficient to fund that more effectively in our current clinical development and drug discovery programs, as well as our program for two hundred million dollars for our stock down. March to pharmaceuticals in federal district court to stop it. The market has been in violation of our patents, our lawsuits. A final FDA approval of those products for 30 months, a period which ended on August 1st. Discovery is underway. Originally promised to begin January 2nd, Twenty twenty one last month. The court begins at 8:00 a.m. Friday to complete preparations by March seven to twenty point for a new product has not been set to take place any time after March 17th. Kevin is also a challenge to Melissa, one of our dads to important importuning is a post grant review where PGR for the US Patent Office found a few more minutes. You know, oral argument in this matter we heard on September 6th respect the refund decision or that the losing party may appeal to the Federal Circuit Court of Appeals, during which time the remaining.

[00:05:31] It's important to note that tether is barred from challenging the validity of patents in the district court. The arguments raised or could have raised seven attorneys will undoubtedly try to do so anyway, are intended to prevent sound bite at that. Apple is a matter of months to resolve such appeals, explains the resolution guards twenty twenty one. Obama did well in the March quarter policy and signs the point was to improve some size of the tax. So the early twenty twenty one, that is December eight, the next year for the decision by the district court to begin on are invalid, unenforceable or not. Branch. And he was trying to separate from litigation against following his own timeline, Markman hearing the case was set for November this year that they stated in the trial date, predicting the timing of any difficult and the possible delays by the covid-19 endemic compounds the problem. And they deserve no trial date, but has not said. Whenever this trial place is way too important to be for the judge, how not to recall that involves.

[Joseph Belanoff, Chief Executive Officer]

[00:07:02] Thank you, Charlie. Charlie Crist, by the way, to attend the school, which is, of course, a stable commercial business, profitable and increasingly broader and clinical development programs. They're currently testing out my portfolio of proprietary, selected for his own isolators, two to basically for single trials. One in three women face to face with a quality trial continue to be three to two trials and metabolic disorders. These trials generate over the next year twenty twenty even traditional model out of the Gulf. I know the company our size that combines commercial success since the first promising. I need to tell you, it is difficult for everyone, covid-19, and, of course, many individual nations to protect themselves production by limiting their exposure to other people. Patients are reluctant to leave their homes, even as many medical practices have, by putting them in person. This is representative. This reduction in safety based on her actions is every aspect of health care especially hurt by a serious condition such as? We're doing what we can to help our commercial. He has devised ways to support position by video teleconference conditions and in. That's exactly the appeal of this procedure to reduce the risk of infection. However, these measures face to face, diagnosing and treating patients. Nonetheless, patients who are using are highly motivated to continue to use. Despite the current obstacles continue, Andrew Luster describes how he is immediately worried for women in affected areas and greatly improve the lives of Asia-Pac face, a life threatening chronic illness and other related changes in medical practice. Patient behavior must be reduced. It's clear that the foundation of our dedication, promoted by dedicated commercial interests, is rock solid with the support of conditions. Of course, there are many patients who did not get any sleep problems except for the core of the core and the tension of the stock repurchase program. You have to compensate for the fundamental strength of our most important use of our cash to fund our commercial operations and our increasingly frustrated development programs. We need to stop because this program is undervalued. I think it's. As you are evaluating the overall success of the U.S. retrials, who are not aware that this is, after all, run by the generals, who is not caught off guard and says the termination of pregnancy is an issue that will be impossible, believe that.

[00:10:47] A different mechanism for all with this idea, because in the past, serious side effects for one percent of the trial for all these types of EBITDA is a leading waste. From the corn based ethanol that a positive experience, the Border Patrol, as well as in a variety of other states, anticipates there were no more and national reading and also no drug induced approach to presenting these results can be found at the investors assistance of our website. Is of phase three rape trial, certainly between the star and brings good news patients in Central America and this case extensively in the second quarter, Twenty twenty to. Last quarter, the first patient, the second phase of the trial, the greatest trial we know of world's best indigenous Australia syndrome is caused by the patient with the age of experience and the rather than trying to all the way that health outcomes for Brady and the British controlled state, patients with this type of insecticide will contribute to the outcome for its patients. Progressive immigration policy in general employment, fifty or twenty two is the primary endpoint, a statistically significant improvements, hypertension about. All of the other counties in the state prison system was a family of the United States, the investigators were participating in Greece who also participated, embraced by their personal presentation, creating design, research and pipeline conversations to have our website. Foreign policy program originated in series populated by investigators. University of Chicago, what you change your trials to produce data for the first half of next year? Our program is examining the exercise of cortisol modulation that can treat patients with solid tumors. Is going to impact program programs that chemotherapy can be this compelling data suggesting that real can. You therapy is potentially leading cause of death. We are testing this hypothesis. This is a message that we are convinced that. He initiated the trial following the 13 year old case, went to trial for the past 17 Craxi to 25 days of pancreatic cancer and the discovery of cancer in Shrivastav for 16 weeks or longer to pancreatic cancer, tumor shrinkage for sixty five weeks. All patients had experienced disease progression through multiple prior lines of chemotherapy, including the Tassie's, we presented these results as Twenty twenty 19. You can find out from the research and pipeline out of our website. In order for the general population to realize that it was a free trial will not have a factual basis against pancreatic cancer. Basically, she wants to tax the primary endpoint subjectivist on three secondary endpoints, including progression free survival, operational response, instead of the analysis of results. Firstly, patients in the first half Twenty twenty one. Instead, the response rates have the tax on monotherapy in cases patients, Mosaddeq pancreatic cancer is believed to be a positive result. The alliance supports. He's alive. We can be reasonable in our control phase two trial is.

[00:15:34] 278 patients were randomized to receive paclitaxel and either continuous dosing the world was either the primary endpoint, free survival, secondary endpoint, the response rates, duration of response, we expect results reached in the first half of next year. Also, according to the DEA agent, suppresses the immune system, which is why synthetic cortisol are used to treat autoimmune inflammatory disorders such as now sclerosis. Abortion suppressing the news stories also diminishes the effectiveness of therapy, treating patients who solid tumors, the timber we initiated before Labor Day for Laetrile, plus people in separate rooms for a country that patients with advanced degree of cancer tumors produce excess cortisol in patients. Several days after the general cancer, 10 days during that competition is only the cause of excess may also counteract the intended effect, which is rarely effective as monotherapy patients. For trials evaluating the Iroquois treaty, and this means that authorities and by reversing course, all of these suppression also allowed to keep its own cancer at. I'm at this year's ASCO and ACR meetings and preclinical and clinical biomarker data supporting our hypothesis. We do the research and pipeline publications, our website. We can do all 20 patients in this trial, five sites in the United States. The primary endpoint is objective response rate, secondary survival, duration of response. Investigators at the University of Chicago and Shirley corticosteroids to reputations patients, castration resistant prostate cancer.

[00:17:54] Finding that was confirmed by researchers at Sloan Kettering Cancer Center this morning explained why patients treated with widely prescribed receptor antagonists experience. We need to address the crisis and restimulation and tumors often utilize cortisol as a great pathway, Unpartisan added. Cortisol modulators modulator deprivation therapy is risky. It won't be trial in the courtroom later as well and truly to deal castration resistant prostate cancer, test that to identify those responsible for advancing to a larger controlled site where. I will completely be happy about progress made about. In the United States, six million people take medications and to be willing to accept FRAXA, an imperative to treat illnesses such as schizophrenia, disorder and major depression. Police do a very effective the exact right in front of the same kind of vascular disease about stroke patients, patients can begin with breaking down and the life expectancy has decreased by 20 years, due in part to excess cardiovascular events, heart attacks and completely blind from clinical trials in healthy subjects in which country ministration, the causal modulator, reduces dangerous metabolic adverse effects to these trials. Using the phrase the active ingredient in a positive is also published in the journal. And there are these. Unfortunately called We Cannot Be Advanced the same prevalence disorder. The Arab world, by contrast, is much of which can be enhanced for the kids who are going to trial and which is the key to the success of the rest of the Arab world in the last 40 days.

[00:20:14] If this happens, the world is going to wait and see that in addition to a smaller increase in triglycerides, liver enzymes, 60 and 80 of liver damage right now to begin planning to publish the results of the study next year. Currently conducting a double blind controlled phase two trials for the first. It is valued anywhere near or in reverse recent psychotic state, but I don't think basis points to their established psychotic medication to 600 milligrams in four weeks, reduce the approximately 20 centers across the United States. During the first year, we initiated a randomized controlled trial to treat long American patients depression, see their established as a kind of medication, plus six other plans for ninety four point six weeks. The primary price reduction partially due to 30 percent in the United States. Is that a model for when all the province and reverses fatty liver fibrosis precursors on the Nash series disorder affects millions of patients? They did not intend to start Twenty twenty double-blind things to try for a. To results because of antiquated public health measures and related changes of position in patient behavior. That being said, a commercial business is remarkably stable and poised to continue to exercise its seventh year without a regional and guidance that we now agree to free college for cash and investment dollars, which is going to be enough to prevent repurchase of the stock preclinical programs.

[00:22:44] And we use that money once Twenty twenty to. The is under way in three trials of real climate plans in Sanford. He said trial to provide a basis for a who or twenty twenty to. A second trial raising value for patients could create a large deposits, will help patients better understand. That is story patients can be through on trial, but overall, the actual patients that have gotten cancer will be dealt with the first half of next year. Traditionally, positive results from the riot likely qualify for accelerated approval. I've been through these two trials as the results. The first half last month, we initiated the sweeping improvement label based on the trial run by the Keating One, complaining that we treat patients with advanced cancer and the result, access. Finally, in the first quarter of this year, inspectors left the company for what they have in custody, including the right to control the Houston trial and castration resistant prostate. Metabolic disease is also involved in side activities that continue Raditude, I would like to see looking for ways to try to reduce this, which can be done only gratitude to Dobi, either because they do trials very long to start a double life saving control phase two trials or later this. I'll stop here for questions.

[Operator]

[00:24:52] Thank you. If you would like to ask a question, please press star one on your telephone keypad. And if you're on speakerphone, please make sure the tribute function is turned off to allow your signal to reach our equipment. Again, that is star one for questions or at the moment so that everyone has an opportunity to signal for questions. And we will go to our first question from at this time, our first question will come from Kevin. I'm not a Bank of America.

[Unidentified Analyst]

[00:25:27] Hi, good afternoon, thanks for taking my questions for me. So I guess if you guys end up winning the TTR and let's say also the district court case and you do in that event have no competition for calling for several years, and you also plan on launching reliquaries in questioning. How do you think that both of those drugs could coexist? Is there a subset of the population that might be better served with one drug over the other? Or is it your view that over time scales for Clallam would fade as long as there's more pick up for our client?

[Charlie Robb, Chief Financial Officer]

[00:26:11] Green. Thank is Charlie. So I'll answer the first part of the question and just talk about the two drugs, but I just want to say, if we really think this is true of having, you know, a pattern that has only grown to twenty, thirty seven. So it's 17 years of additional protection. So quite a long time to pressure the police. Want to make it clear to folks that we have that kind of legal success, despite that is the one who has a problem after that.\ But as to the law enforcement generally, thanks for the questions. It seems to be completely straightforward. I think that there is a period of medication to if it pans out the way it has so far, including the professor, a related side effects. And now find out. I told you to take it ago in my expectation that at the time there was entirely replaced as the certain choice drug.

[Unidentified Analyst]

[00:27:26] Ok, and do you think that would happen immediately or would that be more of a, you know, a gradual switch over?

[Charlie Robb, Chief Financial Officer]

[00:27:37] That's a little hard to say, but my expectation is that be sooner rather than later.

[Unidentified Analyst]

[00:27:45] Ok, thank you. And then maybe one question, if our man on a pipeline program for Nash, it seems that there are many mechanisms of action are being explored by many different companies. And and I was curious. It's very early, but how do you think your your particular approach could be differentiated either in terms of efficacy and or safety in that population? Thanks.

[Joseph Belanoff, Chief Executive Officer]

[00:28:13] And I have a beer that belongs to the greatest brewer, and I think you'll take your like. Thanks so much for talking with us. We wish we had the very promising of the moment, and the first thing I like to do, some other words are are. And so that's why we're starting out as a first step and the safety profile, which I think is. And just sort of how we got here, we noticed the patients who were treated for that in one measure, not specifically managed, but people who had one thing of other people with irritation over time, the insides of the normal lives, and that that really started us on the path forward to the the testing that described to if that translates to. That's a possibility for that.

[Unidentified Analyst]

[00:29:50] Ok. And do you have a sense of when we would be able to see that up and up over?

[Joseph Belanoff, Chief Executive Officer]

[00:29:57] And the desperately small the conservatives were hoping to start screaming like imminently, basically, and I'm hoping to have greater.

[Unidentified Analyst]

[00:30:14] Ok, great. Thank you for the question.

[Operator]

[00:30:20] And we'll move to a question from Matt Kaplan of London, Follman.

[Matt Kaplan, Ladenburg Thalmann]

[00:30:26] Hi, good afternoon, guys, and thanks for taking the question to ask a few questions with respect to maybe digging into the impact for the covid-19 pandemic and the problems with the case studies and bringing the best case to study as well. What are you seeing there in terms of challenges?

[Joseph Belanoff, Chief Executive Officer]

[00:30:52] It's a little bit a little bit choppy here, instead of you asking the question where I'm going. This is the corn or the ingratiates.

[Charlie Robb, Chief Financial Officer]

[00:31:02] Now, in terms of the ongoing study and reading studies, the impact of covid-19 on those on those programs under the conditions, then it's tough to do that for everybody.

[Joseph Belanoff, Chief Executive Officer]

[00:31:21] We are still working on our common sense in these remarks and are working on filing.

[Charlie Robb, Chief Financial Officer]

[00:31:34] I'm just reminding those who haven't missed that beginning of the pandemic and we really didn't know what was going to extend the timeline to the point where it is right now. Probably not changed since that time.

[Matt Kaplan, Ladenburg Thalmann]

[00:31:55] Ok, that's helpful. And then in terms of I guess maybe a question for Charlie, you kind of portray it kind of a best case scenario of 2037 four. If everything goes in your direction with the litigation, having a son, can you help bracket that and help us understand in terms of maybe a base case scenario, in terms of how things could progress and the other end of that spectrum, when you could potentially see a generic competition, the way things are playing out right now?

[Charlie Robb, Chief Financial Officer]

[00:32:30] Twenty thirty seven days I mentioned is just a bit of a kind of our longest running and one of the best in college now PGR, that is an important decision about in a couple of weeks. So that's that's within twenty, thirty seven months. And as for sort of you, do you have a very around twenty, thirty seven as rapidly as they can. So if they're going to settle into something that they are getting into the engineering company some amount of time further than that, one would have done it. And but that's just sort of the way the average is working here in your area right now. So I really like it. It's not really taking off. I just I do have one in twenty seven at the civilians and military.

[Matt Kaplan, Ladenburg Thalmann]

[00:33:44] Ok, that's helpful, thanks. And then just in terms of a pipeline question, if I may, the Reliant Phase three study, you mentioned that data from the first half of the study, the first quarter patients would be available in the first half of twenty one. I guess. What should we be looking for in terms of with respect to the primary endpoint, objective response rate? Is that is that the data we're going to see in the first half, in the first 40 patients?

[Joseph Belanoff, Chief Executive Officer]

[00:34:16] And in the interim analysis that we're starting from this sort of stuff is basically the first visit to the surface of the planet at that point, my power to make any conclusions. But that is an indication on where we are and whether we're tracking toward success and and how an end to the nation to continue the trial at a fast pace. And so far, at least. Yeah, just in terms of maybe you can help us understand what objective response rate would be deemed as successful. You know, I pancreatic cancer is obviously a very difficult indication. Absolutely, and and I just I believe that the context for this is the trial allegations the 39 or more of pancreatic cancer is really three people and currently the response for most treatments that can be tried in these patients and very much so that any response would probably be given.

[Matt Kaplan, Ladenburg Thalmann]

[00:35:42] Patient demand for accelerated approval rate is a significant part. And, you know, what is it like to be bothered by something that isn't subjective statement?

[Joseph Belanoff, Chief Executive Officer]

[00:35:57] And we feel that if we had a 20 percent response rate, everybody would like a better less than that. But it's better than therapy. Then have to have a careful look at the data and see what comes out.

[Matt Kaplan, Ladenburg Thalmann]

[00:36:17] Ok, OK, thank you very much. That Roxanne Roberts.

[Operator]

[00:36:26] And we'll go to our next question from Robert Rajastan of Jefferies.

[Unidentified Analyst]

[00:36:34] Great, great, thank you. Good afternoon. Thank you for taking my question. Maybe the first one goes into the question in your mind sometimes because we see both up to potential news that our Genesis inhibitor, both of them are dying like a 300 to 400 million people out of oxygen syndrome. And the given colon already tracking this kind of a range. And how would you have followed this to your expectations or your questions and your research?

[Joseph Belanoff, Chief Executive Officer]

[00:37:14] I apologize, but really breaking up, I can probably 60 percent of what we would say to the media, I'm sorry to make you do that, but I want to make sure that we answer the question you want answered. Now we're getting serious and.

[Charlie Robb, Chief Financial Officer]

[00:37:38] Well, we believe that we can hear you. You know. Yes. Now, can you. OK, great.

[Unidentified Analyst]

[00:38:00] So I just try to understand this, so we have to start with the Genesis Mitigator. They are kind of a 300 to 400 million pixels for Christians in Rome and given column already trashing disarranged. And the how do you reconcile this to your expectation for the Christians in franchise for column and the Collinet?

[Joseph Belanoff, Chief Executive Officer]

[00:38:32] This is such an interesting what if happened, that 100 million dollars and what happened back in the. So the difficulty, I would say right now, there's been minimal impact on the industry. That's what went on. A couple of things to those on the call. This is the medication that has a mechanical mechanism of action is very similar to that, a low price environment that that is sometimes used off label to treat. And the important point there is that the three to four percent and not three broader syndrome spectrum related to.

[Unidentified Analyst]

[00:39:29] Ok, thank you. The next question for the ex-con, so we see that you are going to select the person next quarter, the first quarter, first quarter next year. I'm just curious what needs to be done to selected those? And I believe the last quarter you were targeted towards the end of this year. So I just curious what the length of the total selection.

[Joseph Belanoff, Chief Executive Officer]

[00:40:02] We have from starting the next segment of our Phase one trial, which would lead us to a very important part of the trial in terms of preventing taking longer than we were then. We were hoping it was a surprise at the moment and recruiting patients. And as a result of that, we would be able to make a decision out of the white people's reaction to paragraph one, which is to explain trials that you mentioned. And then in collaboration with industry in Chicago, there is an investigator sponsored trials. Similar patient population as prostate cancer patient and by the first quarter, we to have both of these trials to be able to make a decision on what they want to do.

[Unidentified Analyst]

[00:41:18] Ok, that's fair. OK, great. Thank you. That's the other question for the commission.

[Joseph Belanoff, Chief Executive Officer]

[00:41:26] I think you're right.

[Operator]

[00:41:30] And we'll move to the next question from Robocop of H.C. Wainwright.

[Swayampakula Ramakanth, H.C. Wainwright]

[00:41:37] Thank you. And I just want to check and see if you guys can hear my voice clearly, because I've been a very choppy in.

[Joseph Belanoff, Chief Executive Officer]

[00:41:47] Yes, we can hear you.

[Swayampakula Ramakanth, H.C. Wainwright]

[00:41:51] Ok, so just trying to understand the third quarter, know the revenue run and also trying to look to try and understand the guidance that you put out. So based on your guidance. If I take the midpoint, you know, you're expecting approximately about six percent growth from some from the third quarter base. So just trying to trying to understand the confidence for that number. And is there a possibility to do closer to your previous guidance and at the upper end of the previous guidance?

[Charlie Robb, Chief Financial Officer]

[00:42:33] We are day before you start, I didn't get a chance to introduce the shot trying to do things I can commercialize or let him answer that question.

[Joseph Belanoff, Chief Executive Officer]

[00:42:43] Thanks for the question and I'm going to. But first, I want to talk about what happened over the pandemic and then we'll talk a little bit about the recommendations that you saw. So there are two key drivers, or rather the two key components, one, patient retention, and then the second patient acquisition during this term window, as well as patients. But apparently patients have been challenging. And Joe talked about this during the remarks. So there's three key factors that have impacted us over the last six months and the first and vary state by state. But physicians have move to the more of a hybrid model in the telemedicine. They're not seeing patients with the same frequency that they have previously. Pre pandemics or screening diagnosis rates are down, which, of course, impacts the patient's ability to get diagnosis and treatment and then to get to a hospital treatment regimen for one for you, even if patients are able to go to the physicians or to give their lives, they've been very reluctant to do so. These are very, very sick patients. And due to a preexisting conditions, the virus that they haven't been doing and the third pieces to the puzzle, those practices in health systems have been open to some patients. How many have been closed to the pharmaceutical industry, which impacts our ability to educate new potential prescribers. So, as you mentioned, we need to to a technology platforms and we're doing what we can to try new things. To treat physicians with in-person interaction is not feasible. So in terms of Q4, you know, it's time for a patient to be diagnosed. It takes time for the patient to potentially be in parliament, and then it takes time for them to verify the authenticity of the system. So there's a lag on the first few months. And I already mentioned that is definitely a significant slowdown in physician interaction. And Q2, when everything was shut down with the onset of the 90s, not slowing down, impacting Q3. The changes, I think, have somewhat in the third quarter there was an increase in activity and I expect that that will benefit our.

[Swayampakula Ramakanth, H.C. Wainwright]

[00:45:01] Thank you for that. The next question is from the Pontefract pancreatic cancer trial. I understand from your initial comments that you have the data from 400 patients in the first quarter of twenty one. And could you give us an idea of when you could complete the study and the data from the study is positive? Is that enough to file for an approval or do you need to do another study?

[Joseph Belanoff, Chief Executive Officer]

[00:45:39] I think it's funny, I think the first half I'm in fourth quarter 21.

[Swayampakula Ramakanth, H.C. Wainwright]

[00:45:48] After that, but I think it's a tough spot for them to have to give up on that subject. I think that's an interim analysis of what is taking place in the countries that require a little more elevation so that both sides and then obviously depends on the speed of the moment that we would have and what we currently have from the data. And I like to look for the results of the later.

[Joseph Belanoff, Chief Executive Officer]

[00:46:29] To answer your second question, yes, we need the results that say, would the U.S. would accept or so fingers are pending, that this is a very dangerous situation really to help them in the.

[Swayampakula Ramakanth, H.C. Wainwright]

[00:46:54] Ok, thank you, gentlemen. Thanks for being with us.

[Operator]

[00:47:03] And we'll go to only on authoritativeness.

[Unidentified Analyst]

[00:47:07] Hi there, Charlie, Kansas and Sean, appreciate cats on Election Day. I want to ask you if you voted for.

[Joseph Belanoff, Chief Executive Officer]

[00:47:19] Yes, yes, yes.

[Unidentified Analyst]

[00:47:28] Only after, you know, first over something. Over the gratitude child, and we talked about this about I think about six months ago, but which gratitude child has a more difficult involvement proposition among investigators? And if and if so, when you comment. Can you compare that compare the trial and execution of the two gratitude, one versus two. And let me put it up in the second question. If somebody to do that, what, ten point go for gratitude? One, because I remember that healthy, normal trial that you were just looking for a trend run statistical significance. I want to set expectations. You have a low dose of the old formulation and now you got a little bit of a bar because you're dealing with obese patients, so.

[Joseph Belanoff, Chief Executive Officer]

[00:48:30] Thank you for the question. So first of all, we you want to wait and see attitude to travel from one side and they can make it somewhat arbitrary to document that trial is so difficult to avoid the start of the year. So we think we will probably get the results both at the same time. Q2 Twenty twenty. And that trial is how to protect a five percent. Five percent reduction rate. And then again, uninterruptedly, if you compare it to the housing crisis, you have to keep in mind that wasn't going to. So the extent of the fact that this information.

[Charlie Robb, Chief Financial Officer]

[00:49:36] And a party that is really going to do really well in the phase one inside in Phase one trial to see if the medication was actually a very active animal and the person had shown the results also of a study, similar character to really very pleasantly surprised to see that we got well. And all that said fundraises described. You say it's very different from patients about weight reduction, prevention and weight gain. So we're optimistic because we keep destroying it is that it is the first two studies that actually test that hypothesis in patients reproduction.

[Unidentified Analyst]

[00:50:33] There are trials are really, really quite a contrast for a number of reasons. We ask about the cancer trial, and it's really this is really a thousand dollar question, you know, I was pleasantly surprised at going to Europe, not the United States and Israel and Transglobal. How does that dovetail with how you envision your eventual Crescenta program of expansion?

[Joseph Belanoff, Chief Executive Officer]

[00:51:03] I agree with you about your question. I think I have actually I think it will actually give me an opportunity to present a point that you made a long time to understand that this is a quality free for all your patients, including patients with cancer, that will enable agency to treat a cancer. Is that it really very meaningful and treating their cooking Cipro, but as far as we can tell, really did not do anything in particular that better than the worst of their cancer, although the quality of life actually to improve the state that we're dealing with real world rates and. Three and actually excluding patients with cancer, and so we're not something that we see the same reason. The reason we got here, which is you can really offer clinical benefit, encouraging signs for patients that have a terminal cancer. The really interesting thing about it is I talk about in my opening remarks is whether it's person from an observation observation was given therapy, which is fantastic. And lots of other cancers did not seem to really work at all. The answer is for the patients tumors. And so we are going to see, in addition to anything we think we can provide, including some really meaningful benefit. Can we also provide benefit in terms of a reduction in a situation where there is a trial? Investigators are very excited to try to try that. And it seems like a very logical place for us to start because we thought was would benefit from going to these patients that I don't know, but were very excited to see an excellent combination therapy and to modulation.

[Unidentified Analyst]

[00:53:15] And one last question I have to ask, if you had caught one one three one seven six in phase one and the child of my understand is completed how I was and how do you intend to take it forward at this point or and where where, if at all, will be present?

[Joseph Belanoff, Chief Executive Officer]

[00:53:38] Barry Allen is a guy who knows more about that than some of the great people. Of course, I think it's very important to that.Steps is still a very early age compound. It's just in baseball at this point in time. But we are really a lot of recovering academics here and we collaborate a active academics. I also point out and all the health related to the system is less Alzheimer's disease and alcohol use disorder, a very positive result of this problem. So this is a very interesting concept for us to be interested in its effect in the last decade. Not only did we see an animal, not to mention a decline, we actually saw previous studies and whatever collaborated questions that are highly publicized, unless it's a terrible disease to improve treatment and too much and would be wonderful to be able to provide treatment for these particular therapies to patients. And the other side is sadly the trail to and that's where we need medications did not work. So it's hard to see what to do. Now, you're a little bit ahead of us with just a little go here and probably the time that the next time we'll be able to give an answer to that question.

[Unidentified Analyst]

[00:55:22] Thank you. I appreciate it.

[Joseph Belanoff, Chief Executive Officer]

[00:55:27] But looks like we to be here for our hopefully, hopefully in a productive way. Thank you very much. We're on Tuesday and we will talk to you on Twitter. Thanks very much.

[Operator]

[00:55:41] And again, that does conclude the call. We would like to thank everyone for your participation. You may now disconnect.