CERE (2021 - Q1)

Good morning. Welcome to the Cerevel Therapeutics First Quarter 2021 Results - Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, you will have a opportunity to ask questions during the Q&A portion of the call. Please note that this call maybe recorded. I will now turn the call over to Matt Calistri, Vice President of Investor Relations. Matt Cal

Thank you. Good morning, everyone. We appreciate you joining us for our first quarter 2021 results call. On today’s call, you will be hearing from Dr. Tony Coles, our Chairperson and Chief Executive Officer; Dr. Ray Sanchez, our Chief Medical Officer; Dr. John Renger, our Chief Scientific Officer; and Kathy Yi, our Chief Financial Officer. We will also have brief introduction Ab Ceesay, our new President.

Thanks, Matt. And good morning, everyone. Thank you for joining us for our first quarter 2021 results and business update call. Here at Cerevel, we're building the premier neuroscience company and working to do so in all respects. By bringing together the people, the pipeline and the capital we need to develop new therapies for patients in need. And we've made terrific progress in all three of these essential areas in recent months. On the people front, I'm really pleased that we have welcomed Ab Ceesay to our newly created role of President. With nearly two decades of healthcare operating experience, Ab's strong track record of building commercial organizations and broad leadership capabilities is exactly what Cerevel needs, as we plan for our successful transition from a clinical stage organization to a fully integrated biopharma company. As President, Ab will oversee strategy, corporate and business development, portfolio and program management and importantly, he'll be responsible for developing our company infrastructure and launch capabilities. I know Ab's is going to make a great contribution to Cerevel as we look ahead to introducing new therapies for patients with schizophrenia, anxiety, epilepsy, Parkinson's, and the other debilitating conditions we're focused on addressing. I'd love to turn the call over to Ab for just a moment so he can introduce himself. Ab, good morning.

Good morning. And thank you so much, Tony. I appreciate the chance to say a few words. I'm so pleased to be here at Cerevel, and I'm really looking forward to working with this talented team to build a business - infrastructure, we will need for the next phase of our journey to transform what is possible in neuroscience.

Thanks, Ab. We're delighted to have you with us as we continue our efforts to bring new neuroscience therapies to patients and to build out the company. Also on the people front, we recently announced the appointment of Scott Akamine, as our Chief Legal Officer beginning later this month. Scott brings extensive legal experience in the biopharma industry, having guided multiple companies as general counsel through complex, competitive, legal and regulatory landscapes. We're excited, excited and honored to have both Ab and Scott with us here at Cerevel. Turning now to the pipeline, our portfolio of neuroscience assets consists of five clinical stage programs and multiple preclinical compounds, benefiting from the more than 10 years and over a billion dollars of investment at Pfizer. Through the first part of this year, we've continued our steadied and focused execution on our portfolio. All the programs remain on track for our anticipated data readout timelines. And we are now dosing in all six of our ongoing clinical trials and randomized patients into both of the ongoing open label extension trials for tavapadon and darigabat. As we look forward to the rest of this year, we're eagerly awaiting two key data readouts. The first is our Phase 1b study for CVL-231 in schizophrenia patients. And the second is our Phase 1 trial the darigabat in healthy volunteers for acute anxiety. We have multiple INDs forthcoming for preclinical programs, including two this year, KORA and PDE4 both of which are under evaluation for their potential and major depressive disorder. In addition, with the opening of our new facility in Cambridge Crossing, we continue to focus on leveraging enabling technologies such as gene-editing and artificial intelligence to identify new drug targets for neuroscience diseases. And finally, as for capital, we were proud to announce last month our strategic $125 million financing for tavapadon. Through innovative deal making and thoughtful risk sharing, we have funded the full Phase 3 program for tavapadon through NDA submission. This transaction also provides us flexibility to allocate capital to our most promising earlier stage assets as they advance into the clinic. And importantly, it extends our cash runway into 2024.

Thank you, Tony. And good morning to all of you. As Tony mentioned, we continue to execute well on our extensive pipeline of neuroscience assets. And we're on course for up to eight data readouts by the end of 2023. I'd like to update you on the progress for each of our key programs, starting with CVL-231, our M4 positive allosteric modulator or PAM. We're currently conducting a Phase 1b trial CVL-231 in patients with schizophrenia. The data readout of both Parts A and B of the trial remains on track for mid-year. The goal of this Phase 1b trial is first and foremost, to assess the safety and pharmacokinetic profile of CVL-231 and we believe we can achieve a differentiated safety and tolerability profile that avoids the gastrointestinal and other side effects seen with other muscarinic agents. The ongoing Part B portion contains a placebo controlled pharmacodynamic assessment to detect trends in the antipsychotic potential of the compound, as measured by the PAM’s total score over six weeks of treatment. Given the strength of the muscarinic mechanism, we do hope to identify a clinically meaningful magnitude of effect that will inform our efficient advancement into the next phase of development. For context, approved agents have generally speaking shown an absolute reduction in the PAM’s total score versus baseline of 10 to 15 points or greater, and or a five to 10 point benefit on a placebo adjusted basis. Again, we are expecting data for both Parts A and B in the middle of this year. We're also expecting another data readout for this year for Darigabat, our α2/3/5-selective GABAA receptor PAM in acute anxiety. Our Phase 1 proof-of-principle trial is ongoing and is now expected to readout in the fourth quarter of 2021. We're also dosing in our Phase 2 proof-of-concept trial in focal epilepsy, known as the REALIZE trial, as well as its corresponding open-label extension trial. Data in focal epilepsy is expected to readout in the second half of 2022. Meanwhile, our Phase 3 TEMPO program for tavapadon, in Parkinson's disease is ongoing. We continue to dose in all three of the Phase 3 trials. TEMPO-3 and late stage Parkinson's and TEMPO's-1 and 2 in early stage Parkinson's. In addition, we're also dosing both rollover and de novo patients in TEMPO-4, our 58 week open label extension trial. We expect data from TEMPO-3 in the first half of 2023 and data from TEMPO’s-1 and 2 in the second half of 2023.

Thanks, Ray. And good morning, everyone. Let's begin with CVL-871, which is nearest to entering the clinic before discussing CVL-936 and some other upcoming INDs. We plan to study CVL-871 a D1/D5 partial agonist in dementia-related apathy. Apathy is among the most common neuropsychiatric comorbidities associated with dementia, reflecting approximately half of the more than 50 million dementia patients globally. It represents a constellation of symptoms, including diminished motivation, social disengagement, and a reduction in emotional responsiveness. These symptoms result in the loss of an interest in personal well being and relationships, as well as interference with normal daily functioning, including motivation to eat, to dress, to maintain personal hygiene or to take medications. The presence of apathy has been shown to be related to decrease in quality of life, increased morbidity and mortality, along with early institutionalization, and also significant caregiver burden. Apathy is also a strong predictor of disease progression. We believe that CVL-871 could be a potential treatment address this constellation of symptoms that constitute dementia related apathy, CVL-871 is a D1/D5 partial agonist, there's a unique profile from tavapadon, whereas tavapadon drives up to 70% receptor activation of the dopamine D1/5 receptors, CVL-871 has a lower level partial agonism and about 40% receptor activation. We believe that this feature makes it an optimal compound for modulating the complex neuronal pathways that control motivation and reward, pathways where the dopamine D1/D5 receptors play a key role. The impact of dopamine activation after the symptoms in the clinical setting has been supported by two independent Phase 2 clinical trials of methylphenidate and norepinephrine dopamine reuptake inhibitor which showed improvements in both the NPI Apathy global score, and the apathy evaluation scale. As you may recall, in March, we submitted an IND for CVL-871. We now expect to begin screening in our exploratory Phase 2a trial within the next few weeks, and data are expected in the second half of 2022. Next with respect to CVL-936, or a D3-preferring dopamine receptor antagonist, I'm really excited to say that we have received a notice of award for cooperative funding from the National Institute on Drug Abuse or NIDA to support its development in opioid use disorder. We plan to initiate preclinical tox studies before continuing our Phase 1 single and multiple ascending dose trials with 936.

Thank you, John. Let me start with first quarter 2021 operating results. R&D expenses for the quarter were $37 million compared to $27 million for the same period in 2020. The increase in R&D expenses was primarily driven by advancement of our late stage and early stage programs, as well as increased infrastructure cost to support the progress of our pipeline. We expect our R&D expenses to steadily increase as we progress our trials. General and administrative expenses in the first quarter were $14 million compared to $11 million for the prior year period. G&A expense included equity-based compensation of approximately $4 million in the first quarter of 2021 and $2 million in the first quarter of 2020. The increase in G&A expenses was driven primarily by one-time non-cash expenses associated with stock option compensation, as well as, infrastructure to support the growth of the company. As of March 31, 2021, cash and cash equivalents were $343 million compared to $47.5 million for the prior year period. This cash position does not include our recently announced $125 million non-dilutive financing for tavapadon, from which we received the first payment of $31 million in April. With this strong cash position and additional payments expected in the next three years, we will fully fund our Phase 3 program for to tavapadon through NDA submission. We have - and we have additional flexibility to allocate capital to earlier stage assets. Overall, we expect our current position to fund our lead clinical assets to the next inflection point. And our expected cash runway is now extended into 2024. We expect that our eight data readouts over the next three years will provide sufficient opportunity to fund the next phase of our program development.

Thanks, Kathy Ray, and JR. As you can see, Cerevel continues to maintain momentum as we build our company and advance our pipeline. We're laser-focused on execution as we seek to bring new potential therapies to the millions of patients facing challenging neuroscience diseases. We're looking forward to the data readouts we've just discussed in schizophrenia and in anxiety later this year, as well as continued progress in our clinical trials for epilepsy and Parkinson's. And as you've heard today, we also plan to initiate work in dementia-related apathy, substance use disorder and potentially major depressive disorder. We look forward to updating you on these efforts in the months to come. As always, I'd like to thank our employees who have shown so much passion for making an impact on the lives of patients and their caregivers. I'd also like to thank the participants and investigators in our clinical trials for their continued courageous contribution to the development of our innovative therapies. I can honestly say we could not - do without you. Operator, with that, we can now open the call for questions.

Your first question comes from Paul Matteis with Stifel.

Great. Thanks so much and congrats on the progress. Two questions…

Thank you, Paul.

Yeah. Thank you, Tony. Great. Two questions on CVL-231 if you don't mind. First, I would think by now you're either fully enrolled or close to it. Where do you expect the final sample size to end up and what's your kind of final expectation for how well powered the study is for the clinical efficacy signal that you might hope to see. And then second, you know, I think the prior safety work that’s been done with this compound, you disclosed safety tolerability at a high level, but not super granularly. I guess, based on the data that you have, what made you confident that you didn't need to titrate this drug to improve tolerability and retention? And are you still kind of confident in that going into this readout from what you've seen with this trial, at least on a kind of a blinded basis? Thanks so much.

Sure. Thanks, Paul, for the questions. I think I think I'll ask Ray to take both those questions. So I want to summarize them very quickly, Paul, you talked about the enrollment, and then want to have some visibility on our expectation for the final sample size and the potential power to detect a difference but – or a trend in efficacy. And then you also want to have some understanding about the rest of the profile for 231. So Ray, why don’t you take both of those?

Yeah. Thank you, Tony. Hi, Paul. Good morning. So the first one is, yes, we are fully enrolled. As you know that the CVL-231 design had 25 patients randomized for a total of 75, we expect to get somewhere given the discontinuation rate, somewhere between 60 to 65 patients or completers, that will give us enough information to be able to understand the signal and the benefits of 231 in terms of its antipsychotic effect, as well all the other objectives, of course, safety tolerability, like PK profile, as well. In terms of the powering, you know, we're 59% power to detect a seven point placebo adjusted difference. And that's typically what has been seen historically with a lot of the atypicals. So that's how we came up with that, with that estimate. In terms of the titration piece as you know, that Part A look at titration in terms of the top dose of 20 milligrams BID or the 40 milligrams and versus the other doses that were not titrated. And we did not see any significant differences in terms of tolerability or safety when the drug was titrated versus when it was not. So we are not using titration currently. And we will of course look at the totality of the data, both on Parts A and Part B to making up a more informed decision as we are developing our Phase 2 program.

And - thank you, Ray. Also Ray, if you could just clarify the comment on discontinuations. None of those were unexpected or negative in any way. But just amplify that a little bit. It's really par for the course for these kinds of trials?

Sure, sure. So there's two parameters, of course that we look at, we look at, you know, the number of patients that we screen in order to randomize into the trial, and of course, the natural discontinuations that occur throughout the trial. And, you know, the discontinuation rate that we experienced is quite typical for these types of trials and nothing unusual. So based on the totality of those individual randomized in the total that we get we, we observe a discontinuation rate of close to 20%, which is pretty reasonable.

That's kind of par for the course. So nothing unusual, no safety signals, nothing to be concerned with. I just want to…

That’s correct…

Yeah, just so people have a sense of the benchmark for what a standard discontinuation rate might look like, depending on the trial. Okay, thanks. Paul, thanks for the question. Operator, we will take the next one.

Your next question comes from the line of Michael Yee with Jefferies.

Hi. Good morning, guys.

Hi, good morning.

Hey, good morning. Two follow up questions on 231. Could you remind us about tolerability side effects as it relates to cardiovascular effects? I know that these are transient, but just remind us what would be expected? And or what do other drugs of that class show? If you went back to other studies now, would you benchmark that and maybe that would set the stage for expectations. And then also, I think that you're very nicely running additional PET studies that go along with it. Maybe you could just inform us how that would help drive a decision because I think both doses I believe, should have pretty high receptor occupancy. So maybe you're just trying to tease out maybe help out which would actually be more biologically the right dose to take forward and I wonder if you can comment about that as well. Thank you.

Okay, good. Why don't - actually, I think Mike we'll take the second question first, and then we'll come back to the tolerability question, you raised. I will say one thing you asked about other drugs in this class. And I'll just to remind everyone that to our knowledge, this is the only M4-positive allosteric modulator that's being developed. There are other agonist related compounds that hit M4 and M1. But our whole thesis, of course, is that the selectivity of the M4 mechanism is what provides a potential benefit. So with that, JR, if you would start with the answer to the PET studies, and then we'll come back to the tolerability question.

Sure. Thanks, Tony. And thanks, Michael, for the question. So, yeah, so I'll just clarify. So we actually have two different sets of PET studies that are ongoing. So one is a receptor occupancy study. And as you know, when you take a compound in the clinic, you make projections about the dose that you want to achieve to test the mechanism. And you base your receptor occupancy projections on typically preclinical efficacy data. So what we want to do is multiple things with the PET study. So one is, what we want to understand is what is the relationship in the human brain between the peripheral PK exposure, the drug level and the periphery? And what is the CNS level at the binding site, at the receptor in the brain. And so for the receptor occupancy studies, there is a couple of things we're going to get out of this information. One is, what is the receptor occupancy across the different concentrations, but also what we want to do is understand particularly going forward into the studies, and then the next, you know, the late development area, what are the appropriate dose ranges to test the mechanism, and really, the accuracy of the PET receptor occupancy studies helps us understand what the appropriate dose ranging will be as we go forward in later development. Also, it helps us understand receptor occupancy, over the dose timing after the dose. And so you get the Cmax and you get a Ctrough. And we're really – you know, went up to two doses that we've taken forward, as you said, they're really significantly above where we anticipate that we need to be. The difference is between the BID dosing and the QD dosing, what is really the trough concentration, and what is the receptor occupancy at the C24 the concentration at 24 hours before the patient takes the next dose. And so it really is a very informative set of data that really helps us with dose ranging and being successful in the next set of studies. We're also doing the dopamine displacement. And that relates what is the receptor occupancy or the binding of the drug at the receptor and its impact on dopamine. And this is really a PK/PD relationship, again, to help us understand dose ranging. Because both of these doses are high, we're going to have to pick a lower dose to have an effective dose range as we go forward. I hope that helps, Michael, back to you, Tony.

Okay, JR. Thank you for that. JR, why don't you also start a response to the question on tolerability and what we've observed so far in the Phase 1, and then we'll let Ray talk about clinical significance of any of those findings?

Sure. Thanks, Tony. So Mike, as you may be aware, we had before entering the clinic, there was a number of tox studies that were done, and they showed transient increases in heart rate and blood pressure. And they were transient in both in two different forms, or two different timelines of transient and that they were briefly increased around the Cmax time period. But as we dose for multiple days, the effect are tolerated. And so what you saw is a bigger effect with the first dose on the first day. And you see on the second, third and subsequent days. And so it was transient, both for a short period during the day. But also there was a tolerance that appeared where the effect that we saw in the first dose was larger than we saw in subsequent doses. As you know, the data that we've released so far from the single ascending dose study in the clinical setting, recapitulated those transient increases in heart rate and blood pressure. As you know, none of those increases were concerning to the point that anyone would was outside a range of, you know, what we considered safe and tolerable. And as you know, we've gone through the Part A of our Phase 1b program, up to doses up to 40 milligrams per day, which was doses 20 mg BID and 30 mg QD. As you know, those two top doses that we had in Part A were both carried forward into Part D. And we had no concerns about taking those doses forward being safe and tolerable. And those were - those - that Part A dosing as you may remember, was up to 21 days at target dose, and so we feel like we have a good understanding so far with the data we have around safety and tolerability. And with that, I'll turn it back to Tony and Ray.

Thank you. Ray anything you'd like to add either about clinical significance or how we will ensure that we've got a clean and safe therapeutic going forward?

Yeah, sure. Tony, just to add to what John mentioned, currently, we're very encouraged by the data we've observed. There have been no clinically meaningful changes in blood pressure or heart rate. Obviously, we'll continue to evaluate that in as the Part B data readout, but we're encouraged by what we're seeing. And so we'll - we await that. But today, nothing that's clinically meaningful. And so we're very excited about the potential of this therapy for those patients who needed it.

Okay. Thank you, guys.

Operator, we'll take the next question. Thanks, Mike, for the questions.

Your next question comes from the line of Craig, excuse me, Greg Suvannavejh with Goldman Sachs.

Thank you.

Hey, Greg.

Hey, Tony. Good morning, and good morning to the rest of the team. Congratulations on the continued progress. I've got three questions if I could. One first, just following up on the series of questions on 231. Just wanted to make sure that when we see the data, is the goal to be able to select just one dose to take into your further studies? Or is there still a possibility that multiple doses will be evaluated? My second question has to do with your 871 program. And I just wanted to get a better understanding of the endpoint. I don't have a lot of experience with apathy trials, and I just want to get a better sense of what has been the history with apathy type trials, if there is one, and I am assuming perhaps at the endpoint or using is validated or previously used in other clinical trials. And then my last question, maybe this is for Kathy, is just, if we could just discuss the tavapadon financing just a little bit more, I understand, from your prepared comments that there was an initial tranche of monies that was, you know, I guess, recorded by the company. And I'm just wondering what the cadence of the next payments for tavapadon are and whether they're tied to certain milestones? Thanks.

Okay. Thank you, Greg. Let's do them in this order. I'm going to ask Ray to address the question about selection of a dose for the Phase 2 programs for 231. I will say - and then I'm going to ask them to take care of 871 question. But I will say just on 871 and dementia related apathy, I'll remind everyone that there are over 50 million patients with dementia worldwide. We mentioned this in our prepared comments. It's our belief that about half of them have apathy. But there is no currently approved medication for apathy, which is really a syndrome that occurs across the various forms of dementia. So this would be a first indication opportunity in a - for apathy in dementia related disorders. Obviously, we are working very closely with the FDA and had a series of successful conversations with them about how we structure the trials and what we think about in terms of how putting all that together to answer these questions. But I just wanted to provide that contact, Greg, because there really is no prior experience with this particular approach. And that's why our collaboration with the FDA is so important. So Ray, why don't you - if you can just address the dose question for him or anything you want to add to my answer on the 871 apathy comments, and then we'll turn it over to Kathy for expansion on tavapadon financing.

Yeah. Thank you, Tony. Greg, good morning. So the first question in terms of dosing is, as you know, that part of the objective of the current trial is really looking at the PK profile of the two doses that we're investigating. And part of the exercise for us moving forward collective with the receptor occupancy trials that John outlined earlier, is really to understand the dose range. So we're going to have to show in Phase 2 and beyond, we will have to show the minimum effective dose, as well as the top dose. So the plan really is to look at a two doses, what is the minimum effective dose and then what is your top dose. So that's the first question. In terms of the second question on dementia related apathy, that a lot of the work that's been done has been mostly with methylphenidate, as you know, and they use the neuropsychiatric inventory of Part A. We're looking at a series of various endpoints, the neuropsychiatric inventory Part C, which is broader, adds caregiver distress to the assessment, which is very important. We're also looking at the dementia apathy inventory rating scale as a whole series of other scales. And really the objective of the Phase 2a trial is really to understand which of these scales is the best for a signal detection, as well as to show the benefits of this compound in treating apathy. And so working very closely with the FDA. We will look at the collective data as a function of these various scales, and then be able to do the validation work to carve a path forward to registration. So we're excited about the potential, as Tony mentioned, to address the need in this - in this patient population. But it is iterative based on what I just outlined. And again, working very closely with the agency.

Great. Thank you, Ray. Kathy, anything additional on tavapadon financing?

Yes. Hi, Greg. The payment schedule related to tavapadon financing is fairly in the same range of what we received in April. And these payments are automatic. There is no contingencies or any other milestones tied to this payment. Does that answer your question?

Yeah. And from a modeling point this is a, I guess, more of a cash thing. But is this given your expected timelines, should we be thinking about another tranche in this year or for next year?

For next year.

Okay. Thank you.

Okay. Thank you, Greg. Good. Thanks, Kathy. I think it is important to note that there are no contingencies on the payments that we expect this year. Good. Operator, we'll take the next question.

Your next question comes from the line of Umer Raffat with Evercore.

Hi, guys. Thanks for my questions.

Good morning. Of course, good morning…

I have a few, if I may. Sorry, can you hear me?

Yes. As I was just saying.

Good morning. Good morning to you all. I had a couple quick ones on the acute anxiety trial, and then one on the tavapadon deal, if I may. So on the acute anxiety trial, is the duration too short to start to understand the addiction and sedation profile? Perhaps you could speak to benzo data from eight day duration, whether we should or shouldn't expect much there? As well as your expectations on the 7.5 and the 25 milligram dose. Separately, and maybe Tony, this might be more directed at you, given all your experience over the years in various companies in various settings. I feel like tavapadon Phase 2 data speaks for itself, especially in early PD. And most observers would look at that and say, you know, what, the clinical risk, especially in the early trial is fairly limited. So in that vein, it was very interesting see that the way the deal was structured, it allows investors on tavapadon to get their cost basis out for the most part on approval alone. And I guess how did you think about that? To what extent was that part of sort of the negotiation on your end to maybe structure it more on some sort of commercial sales threshold to recover cost bases, et cetera? I'd be very curious. Thank you.

Okay. Very good. Let's see, Ray, if you'd be good enough to take the questions around darigabat and the duration of the trial and the dosing?

Sure, sure. Thank you, Tony. Good morning, Umer. Umer, if you if you look at the trial we're conducting in anxiety, which is a Phase 1 proof of principle trial. It's a co2 challenge of hypercapnia model, which as you know, it's been well validated, and historically sensitive to anxiolytic medications, including the SSRIs, and the benzodiazepines. And so just like J&J that used this model to make a decision with their Orexin-1 Inhibitor program to go into major depressive disorder with anxious distress. We do think that this is a model that, as you know, induces panic symptoms. And then the objective is really to understand the utility of the compound, in this case darigabat to in fact show a signal in treating the pattern of symptoms that have been induced by the CO2 challenge using the panic symptoms checklist as the primary endpoint. And we're looking at two doses, similar doses that we're looking at in epilepsy both at 15 milligrams and 15 milligrams a day for 60% and 80% receptor occupancies, which we believe will achieve efficacy both as a minimum effective dose and also as the top dose. But importantly, there's alprazolam extended release one milligram BID or twice a day, which is also used in the J&J Orexin-1 trials, as an active competitor to show what that demonstrates, and then juxtapose our data with the data they achieved, as well as the data that we achieve, which will then allow us to make an informed decision of what steps to take next, in terms of an indication in patients with anxiety. So that's the trial, the model, and the duration of that - of those of those different cohorts of eight days should be sufficient to show a signal in the panic symptoms that are induced by the model.

Very good. Thank you, Ray. And then Umer, tavapadon, there a couple of things I'd say. I think. First of all, the point we made when we announced the deal is, you know, the whole origin story for Cerevel has been about innovative deal making, you know, the capture of these particular assets and putting them into Cerevel. Bain Capital commitment, as a part of that, Pfizer continuing an ownership stake both at the origin of the company, and then in the SPAC, PIPE transaction. So we've had a lot of, I'd say, creative deal making around both the origin of the company. And we're continuing that and how we think about capitalizing the company as well. One of the things that was really important in this particular transaction was to leverage what I call the power of the pipeline. And in both capitalizing the company, but funding the assets, as well. We've got a wide berth of - a wide number or broad number of assets and programs, some of which like to wrap it lend themselves to non-equity diluted financing. And when you think about the strategic direction for the company, to build out of the portfolio, and the fact that we had an opportunity to do some non-equity dilutive financing, it all came together and made sense because it provides us the maximum amount of flexibility, not just to add dollars to the balance sheet, but in how we designed the transaction itself, which does give us a lot of flexibility. We can pay or repay early, we can repay on the basis of commercial success. I’ll remind everyone that this is a risk shared deal, meaning that there is no recourse for non-repayment without approval of – with tavapadon, and under the ordinary scenarios that we've talked about. So it just gives us an enormous amount of flexibility. And I'm particularly interested, I enjoy the deal making aspect of what we do in this business and thinking creatively about how you advance a pipeline. Obviously, we'll use this as one of the many labors that we'll think about for capitalizing the company. But I love the strategic nature of this, the flexibility it creates, the opportunity to repay at different time points at our option and at our discretion based on what we see. And then I importantly love the risk sharing aspect. So more to come on all the progress that we're making in the clinic. But just keep in mind that we really want to continue this heritage of strategic deal making. Operator, we'll take the next question.

At this time presenters, there are no further questions. I will now turn the call back to Tony Coles for closing remarks.

Okay. Well, thank you guys for joining us this morning. This is our second official call as a public company. We appreciate your support and particularly support of both the employees and the people who make our trials possible, importantly, the patients. We look forward to future updates. Everything so far is on track. And we are delivering, as we said at the beginning of our conversation about the kind of company we want to build and in becoming the premier neuroscience company. So we got a lot of potential shots on goal. We've got a terrific team, happy to have Scott and Ab with us now. So I think we've got all the elements that we need to create the kind of success we hope we can. Thanks for joining us this morning and we look forward to our next update. Thank you.

Thank you. This concludes today's conference call. You may now disconnect.