Q4 2022 Compass Pathways PLC Earnings Call
The code.
[music].
Good day, ladies and gentlemen, and welcome to the Compass pathways Conference call. At this time all participants are in a listen only mode. As a reminder, this call is being recorded I would now like to introduce your host for todays conference Stephen Schultz you may begin.
Welcome all of you and thank you for joining us today for our fourth quarter and year end 2022 results Conference call again, My name is Steve Schultz I'm, the senior Vice President of Investor Relations at Compass pathways and today I'm joined by Bill <unk>, Our Chief Executive Officer, and Mike <unk>.
Our Chief Financial Officer.
Dr. Scott Goodwin, our Chief Medical Officer is unable to join US today, so conveyor will be covering clinical development.
Call is being recorded and will be available on the compass pathways Investor Relations website. Shortly after the conclusion of the call before we begin let me remind everyone that during the call today the team will be making forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095 as.
Amended you should not place undue reliance on these forward looking statements actual events or results could differ materially from those expressed or implied by any forward looking statements as a result of various risks uncertainties and other factors <unk>.
Including those risks and uncertainties described under the heading risk factors in our annual report on Form 10-K filed with the U S Securities and Exchange Commission and in subsequent filings made by Compass with the SEC. Additionally.
Additionally, these forward looking statements represent our views only as of today and should not be relied upon as representing our views at any subsequent date.
We specifically disclaim any obligation to update or revise any forward looking statements, even if our estimates or assumptions change I will now hand, the call over to <unk>.
Thank you Steve.
Good day, everyone and thank you for joining us we have quite a bit to share with you as we continue to make strong progress across all aspects of our business.
During this past quarter, we started at 360 phase III pivotal program in treatment resistant depression, or <unk>, a unique achievement the first ever phase III trial of <unk>.
As you know this is a field that holds the potential for significant advances in the treatment of mental health conditions.
Thrilled to be at the forefront of this potential paradigm shift.
Today, we're announcing an important update to the phase III program. We described last fall Scotty.
Starting with our comp 005 trial.
As a reminder, this is a single dose monotherapy trial, comparing a 25 milligram dose of <unk> 362 or true placebo.
We've completed further analysis of our phase <unk> data with specific focus on the participants in the one milligram arm, who had a minimal psychedelic experience as well as the analysis of our recent data from our placebo controlled study at the University of Zurich using 300.
<unk> in major depressive disorder or MPD.
This data driven analysis has led to a re estimation of the sample size for the comp 005 trial and a revision to our lower expected response to true placebo.
This allows us to reduce the number of patients required in the 005 trial to 255 from the original 378, while maintaining the power to achieve our objectives.
With the reduction in the number of patients. We now expect to complete the pivotal component of this trial the six week primary endpoint by summer 2024.
Rather than the end of 2024 as we previously guided.
Additionally, we finalized the plans for long term follow up for the Phase III program.
Building off the lessons from comp there was zero for the long term follow up trial phase II B study our strategy is to integrate the follow up into the two pivotal trials, which we believe will enable a more streamlined design reduced selection bias and the implementation button on.
Patients and clinicians.
Again to remind you the two pivotal trials are comp very verified, which I described just now and comp zero-zero six a fixed repeat dose monotherapy trial with three arms comparing comp 360 doses of 25 milligram 10 milligram and one milligram.
Where patients will receive the same dose at day, one and a week three.
In both trials, we will follow patients up to 52 weeks building on the six week pivotal analysis of each trial, which we're calling party pay.
The design follows the same principles for each trial.
Part B of each trial will follow for the primary endpoint assessment at six weeks to 26 weeks.
Patients who meet criteria for re treatment in part B, we will have the option to receive a further treatment.
According to their original allocation in both studies, thus preserving the randomized comparison between arms to 26 weeks.
Part C will run from 26 weeks to 52 weeks as an open label component of the trial.
Importantly, all patients who meet criteria for re treatment in policy will have the option to receive a single 25 milligram dose of <unk> 360 open label.
This option is expected to support patient engagement throughout the entire duration of the trials.
It is important to emphasize that there is no change to the primary endpoint of either trial, which is change in mattresses from baseline at six weeks no to our intention to announce the topline results from the primary endpoint of each trial at that time.
Okay.
We are confident that this trial design will provide insights to key questions on durability of effect and the value of re treatments.
Moreover, TRT also behaves like a chronic condition.
By following patients with continuing randomization for 26 weeks.
Longer than as conventional and other major depressive disorder trials, we have the potential to generate unique durability and re treatment data, which could enhance the value of cop 360.
We believe that these amendments will help to generate further evidence that enhances our phase III program and the potential benefit to patients clinicians regulators and payers.
We have submitted these protocol amendments to the FDA, who have indicated they will come back to us by March the 20-F on file.
Hi.
Had any further comments following their earlier feedback on durability and re treatment design principles.
I remind you that this phase III program is already underway and that its routine to have an ongoing dialogue with the FDA as we conduct the trials, especially with our breakthrough therapy designation.
If we do receive further comments, we will of course consider that feedback.
Let me now turn to the broader body of evidence we're developing account <unk> 16.
The phase III PTSD program is progressing with cop 360 dosing of enrolled patients.
In December .
Data from an exploratory open label investigator led initiatives in bipolar depression type two were presented by the investigator at the annual meeting of the American College of Neuropsychopharmacology.
This study investigating the safety and efficacy of a single 25 milligram dose of <unk> 360, psilocybin therapy in <unk> patients.
The result showed positive early signals of efficacy with 12 of the 14 patients meeting response and remission criteria for the mattress scale at 12 weeks after 360 <unk> therapy.
Notably no subtract had manic or hypomanic symptoms or an increase in suicidal ideation.
We believe that these are remarkable data provide further evidence to support the potential of cop 360, psilocybin therapy for difficult to treat depression.
I'll remind you though that this was a small study and these findings now need to be validated in larger studies.
Also in December the <unk> study in <unk>, which I referenced earlier was published.
This randomized blinded study enrolled 52 patients comparing a weight based variable dose of cop 360 to true placebo.
And demonstrated compelling efficacy results with no new safety signal.
See this is further evidence that the potential for cop 360 to help patients living with serious mental illness.
Turning to anorexia nervosa. This remains an area of critical unmet need with no FDA approved pharmaceutical product at the highest mortality rate of any serious mental illness.
We're committed to pioneering a robust phase II trial to build on the evidence already generated in investigator initiated studies.
I remind you that there is no significant body of experience available for this indication. So we are on a steep learning curve.
We've learned that we need to make amendments to our protocol to better meet the needs of this highly vulnerable patient population.
As a result.
Unlikely that we will see top line data in 2023.
Please note that this is a very different patient population from <unk> patients.
Treated largely by different physicians specialized centers.
The need to amend this protocol has no impact on our phase III <unk> program.
In closing <unk>.
Let me reiterate that we believe the last quarter of 2022 was a quarter of strong progress capping a year of extraordinary progress for compass pathways.
Our phase III study the largest most robust ever study and psilocybin is underway.
And we're excited to continue the journey to bring 360, <unk> therapy with psychological support to patients subject to study results and regulatory approval.
I'll now hand, the call to Mike for the financial overview.
Thank you could be here I will start with a brief summary of the full year results and then review the fourth quarter results in more detail.
For the year ended December 31, 2022, net loss was $91 5 billion or $2 16 per share compared with a net loss of $71 $7 million or $1 79 per share during the same period in 2021.
These results include noncash share based compensation of $13 $1 million in 2022, and $8 6 million in 2021.
R&D expenses were $65 1 million compared with $44 million. During the same period in 2021, and G&A expenses were $45 4 million compared with $39 2 million during the same period in 2021.
Our fourth quarter results reflect the commencement of our phase III trial in Tid and a number of places.
For the three months ended December 31, 2022, net loss was $30 9 million or <unk> 73 per share compared with a net loss of $18 4 million or <unk> 43 per share for the three months ended September 32022.
These results include noncash share based compensation of $3 3 million in the fourth quarter and $3 $5 billion in the third quarter.
R&D expenses were $19 8 million in the fourth quarter compared with $14 million in the third quarter due to the phase III start.
The growth in R&D outside development spending and personnel expenses were due to our phase III trial.
<unk> expenses were $12 4 million in the fourth quarter compared with $11 6 million in the third quarter. This increase was due to increased personnel and facility costs, partially offset by decreased legal and professional fees.
We believe that campus continues to maintain a strong financial position with cash and cash equivalents of $143 2 million at December 31, 2022, compared with $173 1 million at September 32022, and $273 2 million at December 31 2021.
Don.
Our cash balance decreased by $29 9 million in the fourth quarter of 2022 due to using $45 3 million in operating cash partially offset by a change of $14 $9 million due to the impact of exchange rates on our cash balances held in British pounds.
The movement in operating cash is largely driven by our net loss, partially reduced by noncash charges and also increases from a number of prepaid phase III expenses to our <unk>, which will be used to support R&D expenses over the next few quarters as our program progresses.
This cash usage was partially offset by $8 $5 million. We received this quarter for our 2021 U K R&D tax credit.
Our cash balance also reflects an increased to record the impact of currency exchange rates on our cash balance after two consecutive quarters of declines the British pound depreciated versus the dollar in the fourth quarter. As a reminder, we hold our cash balance is in dollars.
<unk> and euros in proportion to our spending plans in each currency since we intend to spend these balances rather than exchange them fluctuations in foreign exchange rates are not expected to significantly impact our cash runway, which continues to fund our operations for at least the next 12 months.
We view our strong balance sheet is an important strategic asset, which we intend to manage carefully as we invest to advance promising potential therapies, while at the same time continuing to create value for our shareholders.
As previously indicated we are providing financial guidance for the first quarter and the full year 2023, we expect the first quarter net cash used in operating activities to be in the range of $24 million to $32 million and the full year to be in the range of $85 million to 110.
Million.
The first quarter range is due to the challenge in predicting the precise timing of cash outlays to support the phase III program in its startup phase as the trial reaches steady state enrollment in future quarters, we plan to offer a narrower quarterly range.
And I'll now turn the call back to get here.
Thank you Mike.
Our lead asset <unk> 360 in phase III, we continue to be an industry leader in our area of science addressing complex therapeutic challenges.
Treatment resistant depression is the first targeted indication, but we believe that countries 60, psilocybin therapy has potential for broad application.
We also continue to advance our commercial strategy.
An important step towards this objective is to have reimbursement codes CT CPT codes in place at launch in.
In February we participated in the meeting focused on the final stages of this process and we hope to have the new tracking CPT code available soon and this would be the precursor to the final commercial code.
Our robust and comprehensive strategy is designed to support both the <unk> 360, psilocybin therapy regulatory approval as well as provide the evidence needed bypass to reimburse this new therapy upon launch.
We believe that this strategy can lead to significant value creation, because we continue to execute successfully.
Thank you once again for your participation in today's call.
I will now turn to Q&A, So I will hand, the call back to the operator. Thank you.
As a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced.
Your question. Please press star one again.
These standby, while we compile the Q&A roster.
And our first question is from Charles Duncan with Cantor Fitzgerald. Your line is open.
Yeah, Good morning, Peter and team. Thank you for taking our questions and thanks for the update on the Phase III program that was interesting I did have a couple of questions to ask you on that.
I guess I'm wondering if you could provide a little bit more color on what you saw there.
The prior trials the one milligram.
In our responses that you saw and clearly that has resulted in a sample size adjustment downward but can.
Can you also give us some thoughts on whether or not that changes your perspective on effect size ultimately that youre looking for out of this study.
Thanks for the questions Chad so.
In the phase II B as Youll recall, the one milligram was.
Secondly, the control.
And as we were able to do further analysis as you would expect given this was largely naive population naive to psychedelics, we saw a range of psychedelic experience in the patients on the one <unk>, but the majority clustered around essentially no psychedelic experience.
And that for us kind of conformance to something that looks like.
Placebo response.
When we actually were able to analyze that we were able to see a strong correlation between that and lack of outcome.
And that was our internal data from the phase II data. We were then able to validate some of our thinking around that with the data from the <unk> study in Mds, which again you used a pure placebo.
And that again was able to validate our assumptions around in fact.
Likely lower difference from baseline and mattress on the true placebo arm in carbon 005.
As you'll recall clubs. There is there are six of course uses the same three arms as the <unk>. So we can assume something around the treatment difference.
We haven't disclosed and don't intend to disclose the actual treatment differences that we are powering pool, but what I can confirm is that from our perspective. We are very comfortable that we are looking at a different treatment difference for the true placebo arm, we're maintaining the power with the reduced size, but we're comfortable that that will not affect the.
The integrity of the validity of the outcome.
Makes sense it sounds like the Delta is actually bigger if I may just ask one brief follow up and then I'll hop back in the queue and that is in terms of the in patient engagement that you mentioned.
With carb E being able to take patients out through 26 weeks.
I'm really intrigued with that I guess I'm wondering if that was the result of some feedback from agency or more more importantly, investigators, suggesting that that's what patients wanted or was that just some thinking on your part to suggest that you could really add some value for patients if he knew.
That the drug worked over overtime.
I would say a combination of all those things I mean, as I mentioned, partly it's our learning from <unk> four while we recognize that not having the option for a further dose for all patients.
With potentially a challenge in terms of maintaining them out for a long time, plus we'd actually design that is a separate study where they had to actually re consent as opposed to integrating but yes, clearly from investigators as well and I think it's very clear that understanding both durability from a single dose, but also the <unk>.
Option for re treatment, but in that continued randomized 26 weeks is information that I believe is relevant to regulators clinicians and payors as.
Well of course as patients.
Eric Thanks for taking my questions.
Thanks Jess.
Thank you one moment for our next question.
And our next question comes from Ritu <unk> with Cowen Your line is open.
Good morning, guys. Thanks for taking the question I wanted to ask about.
Just some more details about part B and part.
Five.
What is the threshold for treatment.
Described and the credit call for part B and is it the same or different for part C of O and then I've got a follow up.
So it is real.
What we will retreat people, who either did not remit or who relapse. After remitting. So that is the criteria for re treatment and that will be the option for one re treatment in part b.
Remembering that in part D. It is in line with that original randomized assignment so depending on what dose to a randomized two it's the re treatment with that and again policy open labor will be the same thing.
And is there a particular madras threshold that defines.
We lapsed or is it.
Clinician discretion.
There is a specific one which we haven't done the moment disclose from a competitive perspective.
Fair enough, Okay and then.
Okay.
Interestingly as I say a protocol amendment.
And then can you describe what they buy essentially what what drove them.
I think investors generally are relatively I'm familiar with this patient population.
What consideration.
<unk>, they're very likely new to us as well.
No.
It's a great question. Thank you so what I would say is I mean, that's.
Some of those amendments are straightforward some were thinking more about so I think what we learned was this is a patient population that is highly vulnerable that in fact, the openness the willingness to even participate in that trial is very challenging and perhaps.
From the Iis, where clearly there's an element that investigators are able to work with patients they already know.
Not fully aware of just how challenging this would be so some of the things. We're thinking about is just number of visits and scales get hopefully being kind of.
We actually tried to get too much into that I think that's that's the first thing to make sure that we can actually have screening criteria and the protocol that meets the needs of some of those patient population, but I would say that we expect to continue to learn around this study as we move forward and around the challenges of working with this population.
Understood and can you talk about.
Wanted to be clear you havent actually dose your first patient.
Correct and also can you just talk about how site activation in skylake.
Yes. So you are correct and site activation is going well we have.
More than a dozen sites actually now activated for both over five six.
Just remind you we know that site activation for these studies takes a long time, it's complex getting the individual DEA licenses, which despite all our experience. It's no quicker the second time round. Unfortunately, so that is well underway and again, we have patients in screening, but many of them need to wash.
From ssris or whatever their own so the washout period is extended but we are comfortable with whatever their asset. That's why we've kind of given the new guidance for <unk> 5 million of reiterating the guidance for timing on those six.
Perfect. Thanks for taking all the questions.
Thanks Richard.
Thank you one moment for our next question.
And our next question is from Francoise with principally and accompanies Oppenheimer. Your line is open.
Alright, thanks for taking the questions.
Just wondering you touched on after Mike's comments can be or you use.
Touched on the CPT code and at launch and reimbursement I'm. Just wondering if you can add color to that.
Do you think that it is a very important part of the story.
Sure.
Peter So.
We've recognized from the get go that the psilocybin administration session of kind of six to eight hours is essentially unprecedented.
Learning also from some of what happened with Super Basso around.
The fact that a launch from a monitoring perspective Janssen haven't necessarily put a comprehensive strategy towards this in place we recognize that we actually needed to put in place a.
Code could potentially cover that expanded administration. So the team has actually been working now for a significant period of time with the necessary professional associations, both apa's essentially both psychiatrists and psychologists and other groups made a submission to the MAA. We've now had.
Two meetings and I think the latest meeting in February we're very confident that we will get that tracking code. Now initially clearly this will be a tracking code, but once it issued even during the conduct of the trials will be able to use that to start to understand what actually the allocation of work by <unk> two.
Supporting those administrations sessions and that will allow us to build the body of evidence to turn that into a reimbursable commercial code.
Soon after launch at launch will soon after but.
As I say learning from the previous experience we recognize it was essential to have that new code in place as soon as possible.
As I say that that should be in the next couple of months.
Okay and is that code related to purely the administration or you mentioned the word support or is there any technological support that could be.
And that.
And that goes.
Yes, so our view is that the existing codes can cover the preparation and integration session, which are shorter. This is for the administration's session. On is video as you know we define what we also during that a psychological support noticed therapy because it is not directed at <unk>.
Interventional it really is there to support the patient through the experience, but it needs to be provided by trained professionals.
<unk> is designed to cover that services can last.
Okay, Great and just lastly on that because it is it is it.
Newfield and Theres a lot of unknowns here just to be clear can you just talk about maybe the learnings in the past year or two years of looking at it in terms of the difference between psychological support and psychotherapy in and how has that evolved in terms of your thinking of the approach.
So.
This is Tom.
Topic, which we could dive into much longer I think from our perspective from the campus perspective right from a stall we have seen this as psychological support.
There are things that we think are absolutely critical clearly preparation, it's critical ensuring the right expectations.
Patients, particularly acknowledging we are in a clinical trial setting where there are a variety of treatments may be possible and so on.
But we have always been clear that during the administration of psilocybin itself. This is around support rather than directive therapy.
Very conscious of the fact that there is a very wide range of opinions across the community, but I think from Compass proposed view, we've always been clear to use the word psychological support as opposed to psychedelic assisted therapy and that is where our mind is.
Great. Thank you and congrats on the quarter.
Thanks Ryan.
Thank you one moment for our next question.
And our next question is from Patrick <unk> with H C. Wainwright Your line is open.
Thanks, Good morning, just a clarification on the protocol changes to the phase III CRD program I'm wondering if you would also need the long term outcomes component to submit an NDA for <unk> or would you be able to do that following the top line readouts from five and six trials.
It's a great question and clearly as we start the phase III, it's a little premature to know what our regulatory strategy would be.
We clearly see the primary endpoints still at six weeks of <unk> six what I will point out is that by the time, we get to that primary endpoint for <unk> six we would actually have the entirety of <unk> and have the full 52 weeks.
I think we would see that as a pretty robust data set from a regulatory perspective, but more than that I think it's premature to speculate on what exactly the dialogue with the agency would be and of course, it's data driven.
Yes.
Helpful. I'm wondering if you can discuss whether you intend to move ahead with our phase III trial and comp 360 in bipolar depression, and then I have a follow up on that.
Thank you so we are.
Like I said I mean, the results are amazing, but it is just 14 patients.
12 out of 14 open label single site. So we recognize that in order to really validate that wed have to we are thinking around water design would look like what sort of control arm you would need for bipolar what sort of size, but that thinking is right now and it's relatively early stages.
Got it okay. That's helpful.
Then I guess.
Maybe just a separate separate question.
Just around there's multiple programs of course advancing with short acting short acting mechanisms action, which psychoactive agents. There is also some of the longer acting compounds that are advancing in clinical development and so I'm wondering as the space kind of builds out you know how if you can discuss the.
Vantages of Cop 360, compared to some of those other approaches.
<unk> com.
Compounds like DMT or fiber MEO DMT and how would you expect these advantages of comp $3 60 to be demonstrated in the phase.
Phase III program in some of these other trials that are now underway.
It's a good question I think without.
So Mike my fundamental responses data is what will determine.
Where those agents are best used and so on so.
Everyone.
<unk> by some of the data that's emerging from short acting.
Until it's been validated in much larger studies and in particular some of these questions around your ability that we're attempting to answering phase III onset by other.
Molecules other mechanisms, it's kind of too early to say, how the field, where trade count, but I think what we'd also say that they are very different experiences from a patient perspective, and while there is obviously a school of thought that says by definition shorter acting has a shall we say an easier route to commercialization I think.
It's way premature before we have seen data before we understand the experience of the patients have and saw to know whether in fact duration alone is a kind of key to differentiation. So obviously, we continue to watch the space.
Im pleased that other agents are moving forward with good data I think that's fantastic for the field and for patients, but I think we're a long way from determining what the competitive set ultimately looks like from a patient perspective, and a results perspective.
Okay. That's helpful. Thank you very much.
Thanks, Patrick.
Thank you one moment for our next question.
And our next question is from Alan <unk> with EDF Hudson Group. Your line is open.
Yes. Good morning. Thank you for taking my question could be here.
What I'd like to if you could clarify please.
Would there be a re treatment paradigm in port be both in the <unk> five and.
Oh six trials.
Yes, so as we said earlier for those who do not respond to who after remission relapsed. There is the option for re treatment in part D. Clearly, it's a the patients choice remembering that it will be in their original assigned treatment.
So it is too so re treatment will occur even in the low fives trial.
So re treatment either with 25 milligram or placebo at patient choice yes.
And I think you just clarify.
Just wanted to make sure it did I understand that even those who are not responding well.
Would have the option to be retreated.
Alright, those who went into remission and sell out of remission.
Correct.
And gives us a single re treatment could be yes, yes, okay.
I think I got that.
In your effort to establish a code.
Are you working together with maps.
In that endeavor to potentially harmonize.
<unk> activities, Yes, we are yes, we are as we've said before yes, we are working with labs.
Okay and one last question please.
When would you be able to provide an update on your internal R&D programs into utter psychoactive agents.
Yes.
That's a very good question, although we actually haven't landed on that but we will.
As you mentioned, we did say at capital markets day, we would do that in due course, we will take that internally and come back to you.
Okay, well. Thank you so much for the update.
Thank you Adam.
Thank you one moment for our next question.
Right.
Okay.
And our next question is from Neena <unk> Garg with Citi. Your line is open.
Hey, guys. Thanks for taking my question. So I just have two so first one just going back to the re treatment.
In part B and part C.
Five analytics studies can you just clarify is it only at the six month time point, So week 26 and week 52 in part D that patients can go through.
Second or possibly third.
So think session.
Or kind of patient.
Treated earlier during RPM part D. And then my second question is just on <unk>.
Cash and the balance sheet.
It looks like Youre going to end this year with.
Maybe a couple of quarters, our cash so just curious how you're planning on dealing with the.
Cash rent.
Bradley.
Thanks, Dana sorry, yes, sorry during this whole verbally as hard so to be clear in part B. The option for re treatment would be between $6 26, depending on relapse or failure to respond and then in part C. We would expect that to be pretty early.
In policy for those patients who are eligible and chose to have a 360 dose so that would be.
Soon after the start of the final 26 week open label section.
Okay and then on.
On the runway.
Yes.
Looking at it from a couple of perspectives.
Sort of the financing front and also operating moves that we could make to further.
Lengthen our runway.
On the financing front and it remains a difficult market environment for.
Financing biotechs.
But having said that we have had a lot of interest from investors really since we announced the phase III.
At our capital markets day last fall.
And it's a very serious attention from.
Sophisticated biotech investors so as I mentioned, it's a challenging environment, but there's still an opportunity that under the right circumstances, we could do an equity offering.
Those interested investors.
Secondly, we do have an ATM in place so it's a new investor.
Do you want to take up a position.
Potentially a way for us to issue equity and raise cash.
And then lastly.
Theres I think theres, an opportunity with that now.
In the past we stated that.
We think we're a little bit early stage to be considering forms of debt, but I think in these kinds of market environments, we do have to be flexible.
So under the right circumstances that would be another way to continue to linked to the runway.
Nancy.
And then lastly on the operating side, we've been very disciplined in the way that we've grown the company really since we announced the phase two results at the end of 2021.
And really are just focused on making sure we prepare and start to execute on the phase III.
As well as our two advanced phase III programs and really have data to all further investments.
And being able to continue to have a strong balance sheet.
In the long runway.
And so those efforts will continue.
We've always said, we view our strong balance sheet.
Important strategic asset.
And while we want to pursue these breakthrough potential therapies, we wanted to do it in a way that's going to create value for our shareholders and to date I think we've done that pretty successfully.
That's going to be a key for us going forward.
Got it. Thank you that's helpful.
Thank you one moment for our next question.
And we have our next question from Bert Hazlett with <unk>. Your line is open.
Thank you. Thank you for taking the question covered a lot of ground on this call and I'll just ask I think on intellectual property, if I might one called <unk> 16, you've talked about your protection and patents that expire through 2038.
There were a number of pending applications. So has there been any evolution with regard to IP for <unk> 360 or or other elements that.
Or material importance. Thanks.
Thanks, Bert so.
No nothing new to disclose here, except one note youll recall.
Three of our patents were challenged by another organization that challenge was rejected they appealed and that appeal was also rejected in February so that's actually the only update.
We continue to be confident that we have a robust a state of protection out to 2038.
Thank you and thank you for the additional clarity on the on the re treatment very helpful. Thanks.
Thanks, Matt.
Thank you one moment for our next question.
Okay.
And our next question is from Kyle <unk> with CGS. Your line is open.
Hello, This is tayo sneaking towards Dumont Kulkarni.
<unk> seen from us on.
The open label treatment.
In the development process for that reaching an paradigm.
Company thought of doing the achievement.
As needed basis sort of maybe a longer.
To a longer term duration.
Why that might be.
Implemented thanks.
Thank you Kyle and when you say add on as needed just to clarify youre supervoting multiple retreat months, yes.
For example over like a year duration and potentially more than one day treatment.
It is.
It's a fair question, yes is the answer we considered a variety of designs in terms of how we extend this house and I think.
The reality is we know that our phase III program. However, we design it is not going to answer all those questions to the satisfaction of all our regulators payers clinicians and so on as well ultimately the tradeoff. We arrived that was that in terms of getting clarity on durability of a single dose or potentially two.
Doses and or six.
And what happens with one re treatment recognizing also that per protocol as you would expect as we did it to be at some point you have to allow patients to go back onto antidepressants or something because ethically you cannot expect to sustain them without that so ultimately the interpret ability of multiple doses.
If they are actually already on background SSRI is going to be challenging I think in this case with a single re dosing. The open label that is again interesting data from the perspective of clinicians and so on as to the impact of that on a background of other therapy, but no.
I acknowledge there are there are different designs, we could've gone for we think in terms of interoperability and also balancing the needs of the different stakeholders. This was the right choice.
Got it thanks, and maybe one more and all of the non key R&D studies, such as in bipolar anorexia on their laurels fall or Mtc.
Incidence of suicidal ideation observed.
As of to date and what percent of total would that be.
Okay.
So we will have to get back to you with that data I actually didn't happen.
Not aware of any specific finding but I would need to come back to you with anything, particularly in the Mds study for Missouri, which I will cover as I remember as I mentioned in the bipolar study we saw none.
No there were no examples without among those 14 patients.
And I think Steve is reminding me that.
Some of these are in our investor presentation.
Yes.
Okay. Thank you one moment for our next question.
And we have a follow up question from Frank principally with Oppenheimer. Your line is open.
Alright. Thank you just a quick one here you mentioned March 20th.
I'll be getting feedback from the FDA in terms of your amendment is this something that <unk> is this something that you would.
Clothes, or you'll you'll hear the feedback and adjust accordingly, or just I'm just trying to figure out what we should be waiting for in terms of expectations of that day.
Yeah. So.
As you know typically we have not actually.
Disclose the two in front of our correspondence with the FDA because as you would expect for any phase of the company. We have a lot of children pro including protocol amendments and Tor. We recognize that this was sufficiently significant both in terms of <unk> five and the integration of the long term follow up that we wanted to flag it that said.
We believe so first in terms of the sizing in power and oil <unk> ultimately that's a sponsor decision based on our analysis of the data and what we believe around treatment difference and for the long term follow up that is clearly aligned with the design principles that we had worked through with the FDA. So I think.
We do not see that as a particular clearing event, but we also wanted to acknowledge given the significance of the changes we're making that there is a date at which they've said they will get back to us with comments Tiffany.
Perfect. Thank you.
And I'm showing no further questions at this time I would now like to turn the conference back to management for closing remarks.
Thank you Amy and thanks, everyone. Thank you very much for your participation today, thanks for the many questions and.
As always you know where to find us and we're always happy to take more so thanks, everyone have a great day.
And this concludes today's conference call. Thank you for participating you may now disconnect.
The conference will begin shortly.
Lower Johan during Q&A, you can dial star one one.
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The conference will begin shortly to raise and lower Johan during Q&A, you can dial star one one.
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