Q1 2021 Cerevel Therapeutics Holdings Inc Earnings Call
Yeah.
Good morning, welcome to the Sabra they'll therapeutics first quarter of 2021 results financial results conference call.
This time, all participants are in listen only mode.
Later, you will have an opportunity to ask questions.
During the Q&A portion of the call. Please note that this call may be recorded I will now turn the call over to Matt <unk>, Vice President of Investor Relations.
Thank you good morning, everyone. We appreciate you joining us for our first quarter 2021 results call.
On today's call you'll be hearing from Dr. 20, Kohl's, our chairperson and Chief Executive Officer, Dr. Rey Sanchez, our Chief Medical Officer, Dr. John <unk>, Our Chief Scientific Officer, and Kathy Our Chief Financial Officer.
We will also have a brief introduction to a six day, our new president.
Please refer to our press release from this morning detailing of our Q1 performance as well as our updated corporate presentation, both of which are available on our website.
I would like to remind you that we will be making forward looking statements that reflect our current views related to our financial performance future events and industry and market conditions as well as forward looking statements, including the potential attributes and benefits of our product candidates and the format and timing of <unk> product development.
Activities and clinical trials, we strongly encourage you to review the information that we file with the SEC regarding specific risks and uncertainties.
I will now hand, it over to Dr. Tony Coles chairperson and CEO of Sarah Bell to provide an overview of our achievements and outlook.
Thanks, Matt.
Good morning, everyone.
Thank you for joining us for our first quarter 2021 results and business update call.
Well, 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 walk of H C say to our newly created role of president with nearly two decades of healthcare operating experience AIDS strong track record of building commercial organizations and broad leadership capabilities is exactly what serve all needs as we plan.
<unk> for our successful transition from a clinical stage organization to a fully integrated Biopharma company.
As President April overseas strategy, corporate and business development portfolio and program management, and importantly, he'll be responsible for developing our commercial infrastructure and launch capabilities I know AIDS going to make a great contribution to serve well 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 a for just a moment. So he can introduce himself a 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 Cerro Bell and I'm really looking forward to working with this talented team to build the business infrastructure, we will need for the next phase of our journey to transform what is possible in neuroscience.
As everyone on this call well knows servo is truly an outstanding organization, one with a deep pipeline of promising novel compounds that you do not often seen companies at this stage of development. This is what drew me to serve all the great potential of the pipeline coupled with the fantastic team the.
Tony and others have built here.
I'm truly honored to have the chance to bring my expertise and experience to this exciting organization and I look forward to all of that we will be able to accomplish together Toni I'll turn the call back to you.
Thanks Day, 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 aka, meaning as our Chief legal officer of beginning later this month.
<unk> brings extensive legal experience in the biopharma industry, having guided multiple companies at the general counsel, who complex competitive legal and regulatory landscape, where it fighter excited and honored to have both a bench Scott with us here of terrible.
Turning now to the pipeline or portfolio of neuroscience assets consist of five clinical stage programs in multiple preclinical compounds.
On a fitting from the more than 10 years and over $1 billion of investment at Pfizer for.
The first part of this year, we've continued our steadied and focused execution on our portfolio all of 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 the randomized patients into both of the ongoing open.
Labor the extension trials for tobacco Dawn and the rig of bat.
As we look forward to the rest of this year, we're eagerly awaiting to key data readouts the.
The first is our phase <unk> study for the C V. L 231, and schizophrenia patients and the second is the phase one trial for the rig of bad in healthy volunteers for acute anxiety.
We have multiple ind's forthcoming for preclinical programs, including two this year.
And Peter you for both of which are under evaluation for their potential of 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.
Visas and.
And finally as for capital we were proud to announce last month, our strategic $125 million financing for to that of the Dol.
Through innovative dealmaking and thoughtful risk sharing we have funded the full phase III program for two of Apeldoorn true 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.
As you can see we continue to make great progress here, it's terrible as we execute on our near term priorities build out the capabilities, we need for longer term success and focus on people pipeline and fund.
I'd now like to ask Dr. Rey Sanchez, our chief Medical officer to provide the latest updates on our clinical development efforts right.
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 are 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 CBL to three one R. M for positive allosteric modulator or pan.
We're currently conducting a phase one b trial of CBL to three one in patients with schizophrenia.
The data readout of both parts, a and B of the trial remains on track for midyear.
The goal of this phase one B trial is first and foremost to assess the safety and pharmacokinetic profile of the CBL to three one and we believe we can achieve of differentiated safety and tolerability profile that of voice of gastrointestinal on other side effects seen with other muscular engagements.
The ongoing part B portion contains the placebo controlled pharmacodynamic assessment to detect trends in the antipsychotic potential of the compound as measured by the pans total score of over six weeks of treatment.
Given the strength of the muscarinic mechanism, we do hope to identify clinically meaningful magnitude of the effect that will inform our efficient advancement into the next phase of development for.
For context approved agents have generally speaking showing the absolute reduction in the pans total score versus baseline of.
10 to 15 points of greater <unk> of five to 10 point benefit in the 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 Derek of that Alpha <unk> three five selective Gaba a receptor pan in the acute anxiety.
Our phase one proof of principle trial is ongoing and is now expected to read out in the fourth quarter of 2021.
We're also dosing in our phase II proof of concept trial in focal epilepsy known as the realized 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 III clinical program for tobacco it on.
In Parkinson's disease is ongoing we continue to dose in all three of the phase III trials.
<unk> three in late stage, Parkinson's and temple is the one and two in early stage Parkinsons. In addition, we're also dosing both rollover in de Novo patients in tempo for our 58 week open label extension trial.
We expect data from tempo of three in the first half of 2023 and data from <unk>, one and two in the second half of 2023.
Now that I've covered our three lead clinical programs I would like to hand, it over to John <unk>, Our Chief Scientific officer to briefly discuss some of our other programs John.
Thanks, Ray and good morning, everyone.
Let's begin with CBL, except for one which is nearest to entering the clinic before discussing the CBO of $93 six and some of the upcoming <unk>.
We plan to study CBOE seven one a day one day five partial agonist and dementia related apathy.
At the T is among the most common neuropsychiatric comorbidities associated with dementia afflicting approximately half of the more than 50 million of dementia patients globally.
Represents a constellation of symptoms, including diminished motivation, social disengagement and a reduction of an emotional responsiveness.
These symptoms of results in the loss of interest in personal wellbeing and relationships as well as interference with normal daily functioning, including motivation to eat the dress to maintain personal hygiene or the take medications.
The presence of the apathy has been shown to be related to decrease in quality of life increased morbidity and mortality along with the early institutionalization.
Also significant caregiver burden.
He is also a strong predictor of disease progression.
We believe the CBOE seven one could be of potential treatment address this constellation of symptoms of constitute dementia related apathy.
So in one of the D. One day five partial agonist has a unique profile for them to that but on.
Whereas the EBITDA and drives up the 70% receptor activation of the dopamine day, one five receptors CBOE of seven one is the lower level of partial agonism at about 40% receptor activation.
We believe that this feature makes it an optimal compound for modulating the complex neuronal pathways the control motivation and reward.
As the ways, where the dopamine <unk> receptors play a key role.
The impact of dopamine activation and half of the symptoms on the clinical setting has been supported by two independent phase III clinical trials of methylphenidate of norepinephrine and dopamine reuptake inhibitor, which showed improvements on both the NPI after the global score and the apathy evaluation scale.
As you May recall in March we submitted an IND for CBOE seven one we.
We now expect to begin screening in our exploratory phase Iia trial within the next few weeks and day.
The expected in the second half of 2022.
Next with respect to CBL on $93 six or day, three preferring dopamine receptor antagonist I'm really excited to say that we have received the notice of award for cooperative funding from the National Institute on drug of abuse or neither the <unk>.
Support its development in opioid use disorder.
Turning to initiate preclinical Tox studies before continuing on phase one single and multiple ascending dose trials with 93 six.
Finally, as a reminder, and as you all know we have a robust preclinical and early discovery infrastructure and we expect to submit two new <unk> this year.
We're studying CBL three flow for our Kappa opioid receptor antagonist also known as of Cora intended for major depressive disorder M D D and substance use disorder.
We plan to submit our NDA by the end of the second quarter.
Additionally by the end of this year, we hope to submit an IND for CBL O 47, our selective PDE for B inhibitor, which we believe has potential in both M D D and schizophrenia.
Overall endured of our team's dedication and hard work, we're continuing to steadily advance all of our programs and we remain on track to meet our expected development timelines for <unk>.
Looking forward of multiple data Readouts this year and we're really excited to update you on the continued progress of our portfolio.
But now I'd like to turn it over to Kathy Our Chief Financial Officer to review, our financial performance for the first quarter of this year Kathy.
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 the 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 noncash expenses.
Associated with stock option compensation as.
As well as infrastructure costs to support the growth of the company.
As of March 31, 2021, cash and cash equivalents were $243 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 it to wrap it on from which we received the first payment of $31 million in April.
With the strong cash position and the addition of payments expected in the next three years, we will fully fund our phase III program for to wrap it on through NDA submission.
And we have addition of 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 2020 for them.
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.
I'd like to now hand, the call back over to Tony to conclude.
Thanks, Kathy and the J O.
As you can see sort of all 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 an anxiety of 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 the.
Always I would like to thank our employees, who have shown so much passion for making an impact on the lives of patients on their caregivers I'd also like to think of the participants of investigators in our clinical trials for their continued courageous contribution to the development of our innovative therapies I can honestly say we cannot do this without you.
Operator with that we can now open the call for questions.
At this time, if you would like to ask an audio question. Please press star one on your Touchtone phone once again that is star one to ask in the audio question.
Your first question comes from Paul Matisse with Stifel.
Great. Thanks, so much on congrats on the progress two questions on.
Yes, Thank you Tony Great too.
Two questions on the <unk> three one if you don't mind first I would think by now youre, 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 the C and then second.
I think the prior safety, where it gets from debt with this compound can you disclose safety tolerability at a high level, but not super Granularly I guess.
Based on the data that you have what makes you confident that you didn't need to titrate the drug to improve tolerability and retention and are you still kind of confident of that going into this readout from what you've seen with this trial at least on the kind of a blinded basis. Thanks, so much.
Sure. Thanks, Paul for the question.
I think I think I'll ask ray to take both of 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 the different spot in for.
All of our trend and efficacy.
And then you also want to have some understanding of the rest of the profile for 231, So ray martz to take both of those.
Yeah. Thank you Toni Hi, Paul Good morning. So the first one is yes, we are fully enrolled.
You know that debt CV opportunity through one of design had 25 patients randomized for a total of 75 weeks.
We expect to get somewhere of given the discontinuation rate somewhere between 60% to 65 patients are complete or is that will give us enough information.
To be able to.
Understand the B.
Signal on the benefits of 231 in terms of the antipsychotic effect as well as all of the other.
The other objectives of course safety Tolerability PK profile as well.
In terms of the powering of were 59% power to detect a seven point placebo adjusted difference.
And that's typically what has been seen historically with a lot of the atypical. So that's how we came up with that.
With that estimate.
In terms of the titration pieces, you know that.
Part a.
Look at penetration in terms of the the.
The top dose of 20 milligrams B I D of 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 tight trading versus when it was not so we are not using titration currently and we will of course look of the totality of the data both on parts, a and part b to make it the more informed does.
<unk> as we are developing of our phase III program.
And.
I think you're right I'll also wages, if you could just clarify the comment on discontinuation.
None of those were unexpected or negative in any way, but just amplify that a little bit of it's really par for the course for these kinds of trials.
Sure sure. So there are two parameters of course, if we look at we look at the number of patients that we screen in order to randomized into the trial in the course of the natural discontinuation that occur throughout the trial.
<unk>.
The discontinuation rate that we experiences.
Quite typical for these types of trials on nothing unusual.
So based on the the totality of those individuals randomized and the total that we get.
We observe.
Discontinuation rate of close to 20%, which is pretty reasonable.
That's kind of the it's hard for force so nothing unusual no safety signals nothing to be concerned with.
Wanted to underscore.
Yes, just so people have a sense of the benchmark for what the standard discontinuation rate might look like depending on the trial. Okay. Thanks, Paul. Thanks for the question operator, we will a lot of take the next one.
Your next question comes from the line of Michael Yee with Jefferies.
Hi, good morning, guys.
The Mednet Hey, Yeah. Good morning, two follow up questions on 231.
Could you remind us about.
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 either the drugs of that class of shell. If you went back the other studies on how would you benchmark that.
Maybe that would set the stage for expectations and then also I think that you're.
The very nicely running additional pet studies that come along with it maybe you condition format, how that would help drive the decision because I think both doses I believe should have pretty high receptor occupancy. So maybe youre just trying to tease out maybe help out which would actually be more biologically the right cash to take forward, but anything you can comment about that as well. Thank you.
Okay, good well I don't actually.
Mike will take the second question first and then we'll come back to the Tolerability of question you raised I will say one thing you asked about other drugs in this class and I'll, just remind everyone that to our knowledge. The this is the only and for positive allosteric modulator. That's being developed there are other agonist related.
The compounds that hit in for and M. One, but our whole thesis of course is that the selectivity of the for.
The mechanism is what provides the potential benefit so with that of Jr. Of few would start with.
The answer to the Pet studies and then we will come back for the Tolerability question.
Sure Thanks, Tony and thanks, Michael for the question. So yeah. So I'll just I'll just clarify so we actually of two different sets of pit studies that are ongoing. So one is the receptor occupancy study and as you know when you take a compounding of the clinic you make projections about the dose that you want to achieve to test the mechanism.
And you based your receptor occupancy projections on typically preclinical efficacy data. So what we wanted 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 of the drug level on the periphery and what is the <unk>.
N S level at the at the.
Binding site at the receptor in the brain and so for the receptor occupancy studies. There's 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 wanted to do is understand particularly going forward into the studies and the next you know the late development area.
What are the appropriate dose range is to test the mechanism of really the accuracy of the pet receptor occupancy studies helps us understand what the appropriate dose ranging will be as we go forward and later development also it helps us understand receptor occupancy over the dose timing after the dose and so you get the C. Max and you get a C trough.
We were really the two doses that we've taken forward as you said there really are significantly above where we anticipate that we would need to be the differences between the dosing in the QD dosing what is really the trough concentration and what is the receptor occupancy at the <unk> 20 for the concentration of 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 of the binding of the drug at the receptor and its impact on dopamine and this is really of PK PD relationship again to help us understand dose region.
Because both of these doses are high we're gonna have to pick a lower dose to have an effective dose range as we go forward.
I hope that helps Michael for you Tony.
Sure J R. Thank you Rob for that Jarrett why don't why don't you also start.
The response to the question on Tolerability and what we've observed so far in the phase one and then will let ray talk about clinical significance of of any of those findings.
Sure. Thanks Toni.
So Michael as you maybe aware we.
Before entering the clinic there was a number of Tox studies that were done in the showed a transient increases in heart rate and blood pressure.
They were transient and both in two different forms or two different timelines of transit and that they were briefly increased around the <unk> time period, but as we dose for multiple days of the effect of tolerated and so what you saw as the 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 short periods during the day, but also there was a tolerance of it appeared where the effect that we saw on the first dose was larger than we saw on 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 it was.
Outside of the range of what we considered safe and tolerable and as you know we've gone through the part a of <unk>.
Phase <unk> program up to doses up to 40 milligrams per day, which was dose just 20 make the a D.
And 30 Meg QD.
As you know those two doses that we had in part a were both carried forward into part D. And we had no no concerns about taking those doses forward being safe and tolerable and those were those that part of day dosing as you may remember was that the 21 days of target dose and so we feel like we have a good understanding so far with the day.
We have around safety and Tolerability.
And with the Ed I'll turn it back to Tony in range.
Alright, thank you.
And 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.
Yes, so Tony just to add to what John mentioned currently we're very encouraged by the data we've observed there've been no clinically meaningful.
<unk> and blood pressure heart rate, obviously, we will continue to evaluate that in the.
Part B data readout, but we're encouraged by.
By what we're seeing and so.
We await back but to date nothing that's clinically meaningful and so we're very excited about the potential of this therapy for those patients.
Who need it.
Okay, great. Thank you guys.
Operator, we'll take the next question. Thanks, Thanks, Mike for the questions.
Your next question comes from the line of Craig.
Excuse me, Greg Savant event 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 the first just following up on the series of questions on the $2 31.
Just wanted to make sure that when we see the data is the goal to be able to select just one dose to take.
Further studies or is there still a possibility of that multiple doses will be evaluated.
My second question.
As the do.
With the 871 program.
And I just wanted to.
Get a better understanding of the.
On the point I don't have a lot of experience with apathy trials on I just wanted to get a better sense of what has been the the.
The history with the apathy type trial, if there is one and I E.
Assuming perhaps at the endpoint or using <unk>.
Validated or previously used in other clinical trials.
And then my last question maybe this is for Cathie is just the.
If we could just the.
Discuss the tip of that but on financing just a little bit more I understand from your prepared comments that there was an initial.
The tranche of monies that was.
Yeah.
No.
I guess.
The recorded by the company.
And I'm just wondering what the cadence of the next payments for two of that but on are and whether theyre tied to certain milestones.
Okay. Thank you Greg.
Let's let's do the men in this order I'm going to ask Ray to address the question about selection of the dose.
For the phase III programs for two to three one.
We'll say and then I'm going to ask him to take care of our 871 question, but I will say just on 871 in 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 is our belief that about half of them have apathy, but there is no currently approved.
<unk> for apathy.
Which is really a syndrome that occurs across the various forms of dementia. So this would be a first indication opportunity in.
For apathy and dementia related disorders.
Obviously, we are working very closely with the FDA and had a series of.
The successful conversations with them about how we structure the trials and what we think about in terms of.
On how putting all of that together to answer these questions, but I just wanted to provide that contact Gregg 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 for anything you want to add to my answer on the 87 one.
Apathy comments and then we'll turn it over to Kathy for expansion on to that but on the financing.
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.
The the two doses that we're investigating and part of the exercise for US moving forward the collective with the receptor occupancy trials of John outlined earlier is really to understand the dose range. So we're going to have to show.
In phase two and beyond we will have to show the minimum effective dose as well as the top dose of the the plan really is to look at at two doses. What is the minimum effective dose and then what is your top dose.
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 the methylphenidate.
As you know and they use the neuropsychiatric inventory of park <unk>.
We're looking at a series of various end points.
<unk> inventory per <unk> seen weakness in broader.
Ads caregiver just scrap of distress to the to the assessment, which is very important. We're also looking at the dimension of App at the inventory ratings scale as well.
The whole series of other other scales and really at the end.
The objective of the.
The.
Phase Iia trial is really to understand which of the scales is the best for on 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 on at the collective data as a function of these various scales.
And then be able to do the validation work the carve a path forward for registration so.
We're excited about the potential as Tony mentioned to address the need in this patient population.
But it is iterative based on what I just outlined on again working very closely with the agency.
Great. Thank you Kathy.
Kathy anything additional on to that on financing.
Yes, Hi, Greg.
The payment schedule related to that but on the 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.
Yes.
Sure from a modeling this is that I guess.
On the cash thing, but does this given your expected timelines, we should be thinking about another tranche in this year or for next year.
For next year.
Thank you.
Okay. Thank you Greg good thanks.
Thanks, Cathy I think it is important to note that there are no contingencies on the payments.
We expect this year on next great.
Operator, we'll take the next question.
Your next question comes from the line of Omar Saad with Evercore.
Hi, guys. Thanks for taking my questions.
More of a bank.
I'm sorry can you hear me.
Yes, just as I was just saying good morning. Good morning, Good morning to you all.
I had a couple of quick ones on the acute anxiety trial and then one on the.
To wrap it on the deal if I may so on 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 on an eight day duration, whether we should or shouldn't expect much there.
As well as your expectation.
Spectation is on the seven five on the 25 milligram dose.
Separately and maybe Tony this might be more directed at you given all of your experience over the years and various companies in various settings I feel like to vapid on phase two data speaks for itself, especially in early PD and and and most observers.
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 it was very as you can see that the way the deal was structured it allows investors onto the abadan to get their cost bases out for the most part on.
On approval of alone and I guess, how did you think about that to what extent was that part of sort of the negotiation on your on to maybe structure. It more on some sort of the commercial sales threshold for the two.
For cover cost bases et cetera, I'd be very curious thank you.
Okay very good let's let's see ray if you'd be good enough to take the questions around the wake up at end of the duration of the trial.
On the dosing.
Sure sure. Thank you Tony and good morning, Omar so on.
If you if you look at the the trial, we're conducting an anxiety, which is the phase one proof of principle trial.
It's a cotr challenge of hyper Patheon model, which as you know it's been well.
Well validated and historically sensitive to anxiolytic medications and putting the assets horizon, the benzodiazepines and so on.
Just like J&J that use this model to make a decision with the Orexin one inhibitor program to go into major depressive disorder with anxious distress. We do think that this is a model of that as you know induces panic symptoms.
And then of the objective is really to understand the utility of the compound in this case the rigor back to in fact show a signal in treating the patent symptoms that had been induced by the Seo true challenge using the panic symptoms checklist.
As the primary endpoint and we're looking at two doses.
Of the doses that we're looking at can epilepsy, both at 15 milligrams and 50 milligrams, a day for 60% and 80% for Scepter Occupancies.
Which we believe will achieve efficacy both as the minimum effective dose and also of the top dose, but importantly, there is I will pass the Lam extended released one milligram B I D or twice a day, which is also used in the J&J Orexin one trials.
As an active comparator to show.
What that demonstrates the juxtapose our data with the day to day 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 the anxiety. So that's the.
The the the trial of 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 Omar on to that but on the couple of things that I'd say I'd say for us.
First of all of the point, we made when we announced the deal is the there.
The whole of origin story for Ceragon has been about innovative dealmaking. The the capture of these particular assets and putting them into cerebral based capital commitment.
As a part of that Pfizer continuing an ownership stake both at the origin of the company and then in the spec pipe transaction. So we've had a lot of I'd say accretive dealmaking around both the origin of the company and we're continuing that and how we think about capitalizing.
The company is 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.
A wide berth of the wide number of broad number of assets on programs, some of which like to that but on the lend themselves to non equity dilutive financing and when you think about the strategic direction for the company the 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 makes sense because it provides us the maximum amount of flexibility not just the AD dollars to the balance sheet, but on how we design the transaction itself, which does give us a lot of flexibility we can pay off.
Repay early we can repay on the basis of the commercial success I'll remind everyone that this is the risk share deal, meaning that there are.
There is no recourse for the repayment without approval.
For that but on.
Under the ordinary scenarios that we've talked about so it just gives us an enormous amount of flexibility.
Particularly interested I I I enjoy the dealmaking aspect of what we do on this business and thinking creatively about how the advance of pipeline. Obviously, we will 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 of it creates the opportunity to repay.
At different time points at our option and at our discretion based on what we see and then on importantly loved the risk sharing aspect. So.
The more to come on all of the progress that we're making on the clinic, but just keep in mind that we really wanted to continue this heritage of strategic deal making.
Operator.
The next question.
At this time of presenters there are no further questions I will now turn the call back to Tony Coles for closing remarks.
Okay.
Got it. Thank you guys for joining us. This morning. This is our second for.
Actual call as a public company, we appreciate your support and particularly the support of both the employees and the people who make our trials possible importantly, the patients we look forward the future updates.
Everything so far is on track and we are delivering as we said at the beginning of the conversation about the kind of company, we want to build on and becoming the Premier Neuroscience company. So we've got a lot of potential shots on goal. We've got a terrific team happy to have Scott with US now. So I think we've got all of 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.
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