Study Result

Dec 30, 2019

Good morning, ladies and gentlemen, and welcome to Axsome Therapeutics Conference Call. Currently, all participants are in listen only mode. We will be facilitating a question and answer session towards the end of today's call and instructions will follow at that time. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mr. Mark Jacobson, Senior Vice President of Operations at Axsome Therapeutics. Please go ahead. Thank you, operator. Good morning, everyone, and thank you for joining us on today's conference call to discuss the positive top line results from the MOMENTUM Phase 3 trial of AXS-seven in migraine patients with a history of inadequate response to prior acute treatment. A press release announcing that AXIS-seven achieved the co primary endpoints in the trial crossed the wire a short time ago and is available on our website at axon.com. During today's call, we will be making certain forward looking statements. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our investigational agents, our clinical and non clinical plans our plans to present or report additional data the anticipated conduct and the source of future clinical trials regulatory plans, future research and development and possible intended use of cash and investment. These forward looking statements are based on current information, assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements. Joining me on the call today from Axle's management team are Doctor. Herriot Tabuteau, Chief Executive Officer Doctor. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs Mr. Nick Pizzi, Chief Financial Officer and Mr. Dave Merrick, Chief Commercial Officer. Ariel will start by providing an overview of today's announcement before turning the call over to Cedric, who will review in greater detail the top line results of the MOMENTUM clinical trial. Following Cedric's presentation, we will open the line for Q and A. And following the Q and A, Herriot will provide some concluding remarks. I shall now turn the call over to Herriot. Thank you, Mark. Good morning, everyone, and thank you for joining us today on the call. We are extremely pleased to announce that AXS-seven, Axsome's novel oral multi mechanistic investigational medicine for the acute treatment of migraine met the 2 regulatory co primary endpoints and significantly improved migraine pain and most bothersome symptom as compared to placebo in the MOMENTUM Phase 3 trial. AXS-seven also met the key secondary endpoint demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom for migraine pain. These positive results are especially notable because the study was conducted in a population with difficult to treat migraine and incorporated active comparator, rizatriptan, which is considered to be the fastest acting oral triptan and one of the most efficacious oral medications currently available for the acute treatment of migraine. The MOMENTUM trial enrolled only patients with a history of inadequate response to prior acute migraine treatments. And the patients in this trial exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes. The positive results of the MOMENTUM trial, therefore, have potentially important implications for patient care. Positive results of the MOMENTUM trial are also significant for Axsome as they support the filing of an NDA for AXS-seven in the acute treatment of migraine. We now anticipate filing 2 NDAs in 2020, one for AXS-seven and one for AXS-five in the treatment of MDD. Momentum, which was conducted pursuant to an FDA special protocol assessment, randomized patients to treatment with AXS-seven, rizatriptan, mosaic meloxicam or placebo. AXS-seven met the 2 regulatory co primary endpoints by demonstrating with high statistical significance 2 hours after dosing a greater percentage of patients as compared to placebo achieving pain freedom with a p value of less than 0.001, and absence of most bothersome symptom with a p value of 0.002. Superiority of AXS-seven to its rizatriptan and Mosaic meloxicam components was established and specified in the XPA by demonstrating a greater percentage of AXS-seven patients achieving sustained pain freedom from 2 to 24 hours after dosing compared to rizatriptan with a p value of 0.038 and mesate meloxicam with a p value of 0.001. AXS-seven provided substantially greater and more sustained pain relief compared to rizatriptan over 24 48 hours after dosing, which was highly statistically significant with p values of 0.006.003. This efficacy benefit translated to functional improvement as well as a significant reduction in the use of rescue medication with AXS-seven compared to rizatriptan with a P value of less than 0.001. AXS-seven demonstrated superior outcomes to rizatriptan on multiple other secondary endpoints and was safe and well tolerated in this trial. The seriousness of migraine is underappreciated. The World Health Organization classifies severe migraine attacks as among the most disabling illnesses comparable to dementia, quadriplegia and active psychosis. Migraine damage is family life, social life and employment. A significant percentage of patients experience inadequate response to current treatments. Suboptimal treatment has serious consequences as large scale studies show that in addition to debilitating pain, it can lead to increased progression from episodic to chronic migraine. There is an urgent need for new treatments that provide improved efficacy for the serious neurological disease. AXS-seven is a novel, oral, rapidly absorbed, multi mechanistic, investigational medicine for the acute treatment of migraine consisting of mosaic meloxicam and rizatriptan. AXS-seven is thought to act by inhibiting CGRP release, reversing CGRP mediated vasodilation and inhibiting neuroinflammation, pain signal transmission and central sensitization. Axon's MOSAIC technology significantly increases the speed of absorption of the meloxicam component after oral administration, while maintaining a long plasma half life. AXS-seven is covered by 21 issued U. S. And international patents providing Protection Act of 2,036, and Axon maintains worldwide rights. I would now like to turn the call over to Cedric, who will review the MOMENTUM top line results in greater detail. Thank you, Herriot. The MOMENTUM or maximizing outcomes in treating acute migraine study was a Phase 3 randomized, double blind, multicenter, active and placebo controlled trial to assess the efficacy and safety of AXS-seven in the acute treatment of moderate and severe migraine in adults. The study was conducted pursuant to an FDA special protocol assessment. Only migraine patients with a history of inadequate response to prior acute migraine treatments as assessed by the Migraine Treatment Optimization Questionnaire or MTAC4 were enrolled. A total of 1594 subjects were randomized in a 2:2:2:2:1 ratio to receive a single dose of AXS-seven, Mosaic meloxicam, rizatriptan or placebo following a qualifying migraine. The co primary endpoints of the study were pain freedom at 2 hours and freedom from the patient's most bothersome migraine associated symptom, nausea, photophobia or phonophobia at 2 hours for AXS-seven as compared to placebo. The key secondary endpoints to establish component contribution was sustained pain freedom from 2 to 24 hours after dosing for AXS-seven as compared to rizatriptan and MOSAIC meloxicam. Shown here are the key inclusion criteria. In addition to a history of inadequate response to prior acute migraine treatments, eligible patients were required to have an average of 2 to 8 moderate or severe migraine attacks per month. The characteristics of the patients enrolled reflect the population with very difficult to treat migraine as shown on this slide. The mean mTOG4 score was 3.6 out of a maximum of 8, reflecting patients who are characterized as poor responders to prior acute migraine treatments. In addition to a history of inadequate response, enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes, including cutaneous allodynia or pain from a normally non painful stimulus, which was seen in 75% of patients, severe migraine pain intensity, which was seen in 41% of patients obesity seen in 44% and morning migraine seen in 37%. As noted here, a greater percentage of patients in the AXS-seven group had cutaneous allodynia and severe migraine pain as compared to the rizotriptan arm. There were no meaningful differences in other baseline demographics or clinical characteristics across the treatment groups. Importantly, approximately 40% of patients described prior triptan use. Now to the efficacy results. On the first co primary endpoint of pain freedom at 2 hours, a statistically significantly greater proportion of patients treated with AXS-seven were pain free as compared to placebo, 19.9% versus 6.7%, respectively, for a placebo adjusted difference of 13.2% with a p value of less than 0.001. On the second co primary endpoint of freedom from the patient's most bothersome migraine associated symptom, photophobia, phonophobia or nausea, a statistically significantly greater proportion of patients treated with AXS-seven were free of their most bothersome symptom at 2 hours as compared to placebo, 36.9% versus 24.4%, respectively, for a placebo adjusted difference of 12.5% with a p value of 0.002. On the key secondary endpoint of sustained pain freedom from 2 to 24 hours evaluated in order to establish component contribution, a statistically significantly greater proportion of patients treated with AXS-seven had sustained pain freedom as compared to rizatriptan and Mosaic meloxicam, 16.1% for AXS-seven versus 11.2% for rizatriptan with a p value of 0.038 versus 8.8% with Mosaic meloxicam with a p value of 0.001. AXS-seven was also statistically significant versus placebo on this measure with a p value of less than 0.001. AXS-seven provided substantial and rapid relief of migraine pain as shown on this slide. The percentage of patients achieving pain relief with AXS-seven was numerically greater than with rizatriptan at every time point measured starting at 15 minutes and statistically significant by 60 minutes. This performance over rizatriptan is significant since rizatriptan is widely recognized as the fastest acting and one of the most effective oral triptans. This slide shows the pain freedom rates over time starting 2 hours after dosing. AXS-seven resulted in a consistently greater proportion of patients experiencing pain freedom compared to all comparators with the benefit provided by AXS-seven increasing over time. One of the key goals of acute migraine treatment is not only to rapidly relieve pain, but also to provide durable pain relief that is sustained over time. As is shown here, AXS-seven provided substantially greater and more sustained migraine pain relief compared to rizatriptan, Mosaic meloxicam and placebo. The percentage of patients experiencing sustained pain relief from 2 to 24 hours after dosing was 53.3 percent for AXS-seven versus 43.9% for rizatriptan with a p value of 0.006 and versus 33.5% for placebo with a p value of less than 0.001. Importantly, 80% of the AXS-seven subjects who had achieved pain freedom at hour 2 maintained it through hour 24. The benefit of AXS-seven sustained pain freedom and sustained pain relief is even greater over 48 hours. For example, the proportion of patients experiencing sustained pain freedom with AXS-seven over 48 hours is nearly twice that with rizatriptan in this population with difficult to treat migraine. The efficacy benefits of AXS-seven translated into significantly less use of rescue medication with AXS-seven as compared to rizatriptan. Subjects treated with rizatriptan were almost twice as likely to need rescue percent of AXS-seven treated patients requiring the use of rescue medication versus 35% of rizatriptan patients with a p value of less than 0.00144% of placebo patients also with a p value of less than 0.001. Overall, greater benefits of AXS-seven as compared to rizatriptan were observed on multiple efficacy endpoints in this population with difficult to treat migraine as shown on this slide. In addition to the statistically significant superiority of AXS-seven compared to rizatriptan on 2 to 24 hours sustained freedom and pain relief and on 2 to 48 hour sustained pain freedom and pain relief. AXS-seven was also statistically significantly superior to rizatriptan on the patient global impression of change score with a p value of 0.022, headache pain relief at 1 hour with a p value of 0.04 and return to normal functioning at 24 hours with a p value of 0.027. AXS-seven was safe and well tolerated in this study. The most commonly reported adverse events with AXS-seven were nausea, dizziness and somnolence, none of which occurred at a rate greater than placebo or greater than 3%. There was one serious adverse event of miscarriage that occurred in the AXS-seven arm, which was deemed non treatment related. In summary, in the MOMENTUM study, treatment with AXS-seven resulted in rapid, sustained, substantial and statistically significant efficacy as compared to placebo and rizatriptan in the acute treatment of migraine in patients with a history of inadequate response to prior treatments. The efficacy benefits of AXS-seven translated into significantly less use of rescue medication with AXS-seven as compared to rizatriptan and placebo. Finally, AXS-seven was safe and well tolerated in the study. We would like to thank all the patients who volunteered to participate in the MOMENTUM study. Their participation has allowed us to generate comparative data for AXS-seven against a well established standard of care acute migraine treatment as we strive to bring a new multi mechanistic therapeutic approach to patients who are disabled by migraine attacks and have been underserved by current therapies. We would also like to thank our principal investigators and all the clinical site staff who collaborated with Axsome in the execution of this important study. With that, I would like to hand the call back over to Herriot. Thank you, Cedric. I would like to hand it back to the operator to open the line for questions. Your first question comes from Charles Duncan with Cantor Fitzgerald. Hey, good morning, Herriot and team. Congrats on very nice results in this MOMENTUM study. I have a couple of questions for you. Cedric, you did a great job kind of answering how you established that patients had inadequate response or history thereof. But I guess I'm wondering how did you establish that the patient was experiencing sufficiently moderate or severe migraine to warrant treatment? Thanks, Charles. Yes, so that basically was worked into the electronic device where the patient would respond in their electronic diary. So once the migraine came on and at such time as it reached moderate or severe intensity, that was then the information that they would input into the iconic device, which is part of the course for these kinds of studies, once they put in that it was of moderate to severe intensity, it would trigger it would identify the migraine as a qualifying migraine. And at that point, they would be eligible to continue through the time points, inputting their information as to severity and so forth related to their illness experience. So the device would allow them to continue what is their migraine was identified as moderate or severe. Okay. And then just 2 other clinical questions and I'll hop back in the queue. One is on the ongoing INTERCEPT study in which you're evaluating earlier treatment of migraine, would you anticipate maybe some differences in terms of patient heterogeneity or even perhaps a decrease in the primary endpoint, I guess differences due to greater impact on less severe symptom presentation by placebo? Or would you anticipate actually the reverse to see a greater divergence between the curves? Well, I think it's very important data to generate because what is really characteristic and unique because it hasn't been done before with the MOMENTUM trial has been to look at patients with difficult to treat migraine. So what we wanted to do by designing the INTERCEPT study was to generate data which more reflected real world practice where patients were advised to take treatment on the immediate onset of their migraine pain and to look at those response rates and of course, it's placebo controlled. So it remains to be seen what the data show, but we think that the data generated rather than being in the more difficult to treat population will reflect all comers, migraine pain, earliest onset you treat it and then you see how this treatment will compare to placebo. Got it. And the last question is regarding the long term safety study that's ongoing. Can you help us I know that it's really a different study, but in terms of the patients who went through the MOMENTUM study, what percentage of patients are enrolling in the long term safety study? And just remind us in terms of the requirements for multiple dosing, what would you anticipate in terms of the dosing frequency kind of hurdles in that study? Well, of course, Charles, the difference is that this will be chronic episodic chronic administration of the drug. We patients are eligible to roll over from Momentum. So quantifying percentages or anything like that is premature to say that, but they're eligible to roll over into the extension study. And then thereafter, they will treat their migraines as they occur. And of course, we capture a lot of different data here, but the most important thing is to demonstrate that out to 1 year, patients are tolerating the drug. Okay. Very good. Thank you for taking the questions. Congrats on the results. Your next question comes from Joon Lee with SunTrust. Hi. Thanks for taking my question and congrats on the positive data. I also have a question on FINOCEP study. Is it beginning item for the NDA in second half of twenty twenty? And if so, when can we expect the pipeline? And other than timing of the medication, is there any other differences such as baseline for demographics? June, this is Ray Herriot. INTERCEPT is not gating for the NDA filing for AXS-seven in the acute treatment of migraine. We're on track to report results from the INTERCEPT trial in the Q1 of 2020. And in terms of the differences between INTERCEPT and MOMENTUM, There is one major difference in terms of the demographics, which is that INTERCEPT will take all comers. And so it's more of a frontline population as opposed to momentum, which I enroll patients with a history of inadequate response. And then as Cedric also outlined, the goal of MOMENTUM is to have patients treat their migraine at the earliest sign of pain as opposed to the MOMENTUM trial in which patients were required to wait until their migraine had reached either severe intensity or moderate intensity. Okay. And I have one follow-up. Given really significant positive impact of combining the triptan with mozapine meloxicam, do you have any future pipeline finance for combining mozarek meloxicam with other drugs for additional pain indications in the future? Thank you. So, Exelon is a pretty broad pipeline, and we do have a pipeline of assets that are not CNS. So these are non core assets. One of them is actually AXS-six, which does combine Mosaic meloxicam with another agent through another indication. So right now, to be clear, our focus is on our CNS pipeline. And so we're looking forward to filing the NDA with AXS-seven next year. Your next question comes from Ram Silvaraju with H. C. Wainwright. Thanks very much for taking my questions and congratulations on this very strong data. So again, just to clarify, I wanted to ask whether you have more detailed thoughts on the potential read through for the INTERCEPT top line data readout given the current MOMENTUM data, what we should be taking away from the MOMENTUM data set as the most key perspectives as we approach the INTERCEPT data readout? Secondly, wanted to ask about whether you have had discussions with the FDA regarding the safety labeling for AXS-seven and if specifically there would be any contraindication for use in individuals who have multiple cardiovascular risk factors? Or if that's not yet come up? Or if you don't think that's likely to be a factor going forward at all? Also wanted to ask about the safety profile specifically relative to the cardiovascular context that was seen in the MOMENTUM trial? And then lastly, I wanted to know if you could comment on what we have seen so far with respect to the efficacy profiles of the anti CGRP agents in migraine and how that compares specifically to AXS-seven in the treatment context, not the prevention context? And how you expect AXS-seven to potentially be deployed assuming approval in the context of competitive field that includes both the injectable and oral anti CGRP agents? Thanks. Okay. So thanks, Ram, for the multiple part questions. So I'll answer some of these and then turn it over to my colleagues to provide color on some of these answers. With regards to read through from MOMENTUM to MOMENTUM trial is we now have efficacy data with AXS-seven, which shows that in a clinical trial that set a very high bar, very difficult to treat patient population against one of the most efficacious migraine treatments as an active comparator that we were able to show not only strong separation from placebo but also from the active comparator. So that certainly bodes well for any subsequent trial that we might do looking at the efficacy of AXS-seven. So that's the read through to ANRCEP. With regards to the safety labeling for AXS-seven, we would fully expect that would inherit the safety precautions that are in the labels for rizatriptan and also for meloxicam. Just as a reminder, in our mindset survey and also in other physician surveys, the percentage of patients who do have cardiovascular contraindications to migraine treatments was reported at somewhere between 10% to 15%. That's a minority of patients. And with regards to the safety profile of ANX-seven in the trial as it relates to the cardiovascular context. The drug has been currently well tolerated. And as we mentioned, in fact, the most commonly reported adverse events were all lower than placebo. There were no cardiovascular adverse events in the AXS-seven arm in the study. And as it relates to as the efficacy profile of AKS-seven as it relates to anti CGRPs or anti CGRPs, First of all, we should note that our study was enrolled in patient population, which is different from that enrolled by other current other recent studies. So again, this was a patient population with a history of an antibody response, a very difficult to treat patient population. This is the first time that this patient population has been studied in a long efficacy trial like this, whereas the data for the other agents that are out there, the other recent agents, all study a frontline setting. Having said that, the therapeutic gain, which we saw with AXS-seven compared to placebo was on the order of 13 points, which is on the higher end. It's actually higher than what has been reported with many of the oral anti seizure piece. But again, we would caution that you should not make cross trial comparisons since we are studying a much more difficult to treat patient population. And then with regards to the commercial aspects of AXS-seven, and I'll turn that over to Dave. Yes. Thank you for the question. I think one of the things that we really look at in terms of where AXS-seven would be positioned is really understanding what's the unmet need in the marketplace. And while there's been a fair amount of discussion on what are the most prominent unmet needs, Clearly, efficacy seems to be what's driving the greatest unmet need out there. And that was confirmed in our mindset survey with just over 100 physicians who treat migraine in a survey we reported out last month, where 80% of physicians believe that efficacy is the greatest unmet need. And so when you look at the data that we just generated and going head to head against what many would be considered to be the most effective triptan available today and having superiority data, which we think is distinct, then when we put that profile in front of physicians, we weren't tremendously surprised to see their willingness to prescribe AXS-seven. And in fact, in the survey, when we asked that question, 87% of physicians said that they would prescribe AXS-seven over emerging therapies, which included oral anti CGRPs or the GPANS. So we feel very confident that we are solving the right problem out there in terms of efficacy. We feel like our data is distinct and showing superiority over current standard of care. And the survey data that we have with physicians confirms a very high likelihood to prescribe over emerging therapies as well as current therapies. Thank you. Next question comes from Yatin Suneja with Guggenheim. Hey, guys. This is Derek on for Yatin. Congratulations and thanks for taking the questions. We just have a couple. In order to file in by the second half of twenty twenty, could you just kind of you guys have any plans to maybe expand the clinical program to include a prevention type study with AXS-seven? Thank you for the questions. With regards to the safety database, we do need to have safety data on 100 patients treated for 1 year and 300 patients treated for 6 months. And I think total number of treated patients that would be probably 1,000 or so. And then the way that it works with the dosing schedule is that patients in our open label safety extension are required to treat basically every migraine that they have. And so we collect all that data. That open label safety extension trial has been ongoing since early July. So we're pretty happy there. With regards to studying HSS-seven in the prevention setting, that is a very interesting concept. And the reason for that is one of the rationales behind the MOMENTUM trial and enrolling the patient population that we enrolled is the data from large surveys showing that suboptimal treatment of the suboptimal acute treatment does lead to progression to chronic migraine. And so we will certainly be looking at that on a longitudinal basis in our ongoing long term studies to see on what the potential impact would be or will be on migraine frequency over time. Great. That is very helpful. Thanks and congrats again. Thank you. Next question comes from Matt Kaplan with Ladenburg Thielman. Congratulations on the positive results. Just wanted to dig in a little bit more in terms of how you're thinking about the commercial opportunity for AXS-seven and if you have plans to partner in the U. S. Or partner outside of the U. S. And how you're going to approach the commercialization of 7? Yes. Hi, this is Dave. Good morning, Matt. Thank you for the question. I think we've said previously that our plans are to seek partnerships outside the U. S. However, we have every intention of commercializing AXS-seven within the U. S. And we are building our commercial capabilities to ensure that we can maximize the opportunity. I think with the results we reported previously in the depression category, this gives us a tremendous opportunity to look for synergies across not only the patient base, but the prescriber base. So we're very excited about the potential to commercialize within the U. S. As Axsome and looking across the therapeutic areas to have not only a highly effective commercial effort, but a highly efficient commercial effort as well. And we have a question from Myles Minter with William Blair. Just my first one is actually on the rates of nausea as most bothersome symptoms in this trial. Do you have those rates? And how well was that symptom particularly treated at to 24 and 48 hours? And my second question is to do with patients who at baseline, if they came in with medication overuse headache. You showed a reduction in rescue medication usage. I'm wondering whether or not KOLs are thinking about this class in addition to your meloxicam here as a solution to that very prevalent problem there? And also, if this trial was actually a true single dose AXS-seven trial or whether these patients could voluntarily take another dose at 2 hours? That's it for me. Yes. Thanks for the question. So let me do the last piece first. It was a pure single dose trial. So they can only take one dose of study medication, which is important when you think about other trials where you're allowed to take a drug again, this was one dose and you're done. So it speaks even more strongly to the efficacy benefits that we saw. Your question around overuse headache, again, we work very hard to make sure that the patients coming in had migraine pain as opposed to other types of headache, which would complicate the picture as you're trying to look at for migraine. But you raise a really good point because given that the population of patients in this study was so unique in terms of being difficult to treat, you can imagine that these patients have been, to speak colloquially, so much through the middle in terms of trying treatments and not getting any benefits. So there is a tendency therefore to overuse medication coming in. So I'm sure that the patient population had quite a degree of that historically as well as all of those other characteristics, which we pointed out, are associated with poor outcomes. But then but overall, you try to make sure that you have a pure migraine population that are experiencing migraines, so you can look at the efficacy of your drug. Did I miss up my view? So in terms of nausea, these rates are very, very competitive and very low, didn't occur greater than none of the adverse events occurred greater than the rate of placebo. Or if they did, it was less than 3%. Knowledge it was very low. We captured it at any time point over the safety follow-up period. So you just you ask the patient to describe their adverse events or report them, very low, very competitively low rates compared to other studies. And also, you have to bear in mind that nausea is also a component of the disease under study. So that comes into it as well. You have to factor that in. But again, very low rates. Tolerability does not appear to be an issue with the drugs. We're very pleased with the findings there. Great. And if I may just add one thing to Cedric's answer around medication overuse headaches. That's one of the reasons why we found the reduction in the use of rescue medication so compelling. It was a large separation there from not just riser, triptan, but also from the other treatment arms. And this should speak well to the potential to avoid or certainly reduce medication overuse headache. Great. That's helpful. My question around nausea was more to do with what proportion of patients selected that as their most bothersome symptom coming into the trial as opposed to photophobia, funophobia and how well that particular symptom was treated at through 24:48 hours? Yes. No, that's a great question. And we just received the data, and we wanted to get it out as soon as possible. So we're going to dive down into further detail on the photophobia, monophobia and nausea piece of the most powerful symptom in subsequent analysis. Okay, great. Cheers. Thanks for the questions, guys. Happy New Year. At this time, I will turn the call over to the presenters. Thank you all for attending today's call. We are very pleased with the MOMENTUM data readout given its potential implications for the care of patients with migraine, which is a highly disabling neurological disease. We look forward to filing an NDA for AXS-seven in the acute treatment of migraine in the second half of twenty twenty. As a reminder, as we discussed, AXS-seven is also currently being studied in the INTERCEPT trial, which is evaluating the early treatment of migraine. And we are on track to report top line results from that study in the Q1 of 2020. Earlier this month, we announced positive results, term of Phase III trial of AXS-five in the treatment of MDD. That enables the filing of an NDA for AXS-five next year. So we therefore now have the potential to file 2 NDAs next year, one for AXS-seven and one for AXS-five. We also announced earlier this month positive Phase II results from our AXS-twelve product candidate in the treatment of narcolepsy. We anticipate launching Phase III trials with AXS-twelve next year. So when you step back, this has been a very productive month for Axsome. And 2020 promises to be a year of continued clinical and regulatory momentum for us. We anticipate next year filing 2 NDAs, top line results from our ongoing Phase III trial with AXS-five in TRD and in Alzheimer's disease agitation, top line results from our ongoing INTERCEPT trial with AXS-seven in the early treatment of migraine and also the initiation of new Phase III trials of AXS-twelve in the treatment of narcolepsy. We recently completed a financing, which provides us with a very strong balance sheet, and this allows us to effectively execute on these upcoming milestones. I would like to thank the Axsome team for their hard work and dedication, which is allowing us to advance our CNS pipeline with the goal of providing new treatments for the millions of patients who have failed by current therapies. Thank you, and we look forward to speaking with you in the coming year.