Q3 2022 Mind Medicine (MindMed) Inc Earnings Call
[music].
Good day and welcome to the mine Medicine third quarter 2022 financial results and corporate update conference call. At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.
You May press star one at any time during the call if you'd like to ask a question.
As a reminder, this conference call is being recorded it is now my pleasure to introduce your host Robert Barrow, Chief Executive Officer, and director at Mind Medicine. Mr. Barrel you may begin your conference.
Thank you operator, and good morning, everyone.
Welcome to mind mid third quarter, 2022 financial results and corporate update conference call.
Prior to market open today, we issued a press release with the summary of our results for the third quarter of 2022.
The press release reporting our financial results is available in the investors <unk> media section of <unk> website, and our quarterly report on Form 10-Q for the quarter ended September 32022 is planned to be filed today with the Securities and Exchange Commission.
Joining me today is Sean Greenway, our Chief Financial Officer Dr.
Dr. Dan Carlin, our Chief Medical Officer, and Dr. Larry <unk>, our executive President.
During the course of today's call I will provide an overview and update on our business then.
And then Shawn will review financial results for the quarter ended September 32015.
Followed by Q&A.
Before we begin let me remind you that during this conference call, we will be making forward looking statements.
Company's actual results may differ materially from those expressed in or indicated by such forward looking statements.
For a description of risks please refer to our recent filings with the Securities and Exchange Commission.
During the course of the third quarter, we continued to make significant progress across our business.
Getting within then 120 or LSD D titrate in the third quarter, we dosed the first patient in our phase <unk> dose optimization study and then 120 the treatment of generalized anxiety disorder.
Study enrollment has continued to progress. According to plan, we remain on target for a top line readout in late 2023.
In September results from the LSD assist study, which is a phase II placebo controlled investigator initiated clinical trial LST and the treatment of anxiety disorders. It was conducted by our collaborators at University Hospital Boswell was published in the peer reviewed scientific journal biological psychiatry.
Top line results from 46 patients with clinically significant anxiety demonstrated significant rapid durable and beneficial effects of LSD and its potential to mitigate symptoms of anxiety and depression.
Enrollment in our phase II proof of concept trials low repeated administration of <unk> 'twenty and ADHD has also continued to progress and remain on track from a top line readout in late 2023.
With respect to <unk>, and then 402 or our MDMA program, we continue to progress preclinical R&D efforts in preparation the initiation of a phase one clinical trial in 2023.
Additionally, through our collaboration with the University Hospital Basel in the third quarter, we initiated a phase one pharmacokinetic and Pharmacodynamic investigator initiated trial of R. S and racemic MDMA and healthy volunteers.
This study seeks to assess two dose levels of RMB MMA and one dose level each of receiving an SMB DMA and we expect will provide valuable insights into the clinical activity and then for OTT as we progress our sponsor development program targeting core symptoms of autism spectrum disorder.
Additionally, our external collaborations in early R&D activities have continued to progress, including the investigator initiated study LSD in the treatment of major depressive disorder being conducted at UHD.
Our collaboration with <unk> lab at UHD continues to offer the opportunity to generate modern high quality data demonstrating lst's clinical activity in brain health disorders and continues to provide useful insights to inform the potential future direction, and then 120 development.
We've continued the efforts disclosed in our second quarter earnings call. The service streamline our operational and financial efficiencies and we continue to prioritize and focus our current development efforts and resources on and then 120 and psychiatric indications and then for <unk>.
I would also like to take a moment to discuss our intellectual property position strategy.
As you are all aware, Alex DNS Freebase form was discovered in the 19th of <unk> by Sandoz Chemists Albert Hospital.
Accordingly, IP has been available on all the freebase. However, we believe we have made meaningful improvements and innovations on the original form or LST and the development of our proprietary product candidate and then 120.
This includes advancing both on the active pharmaceutical ingredient LST, you titrate and dosage forms that I'll ask Steve's guitar trait that we believe are optimized to meet modern pharmaceutical standards.
In the third quarter of 2022, we converted several non provisional patent application, which we believe could play a central role in the protection of Am 101.
Should the claims in those applications be granted.
Extra date would be in 2042.
We continue to retain all rights to our intellectual property clinical data manufacturing rights that we have filed on our product candidates and will continue to aggressively protect and expand our IP portfolio seeking to maximize the protection of our product candidates should they eventually be approved for marketing.
I'll now turn to our platform of digital medicine products, which is strategically aligned with our drug development programs and we believe has the potential to facilitate broad and diverse access to our product candidates.
Under our mindset session monitoring system or an SMS platform. We've continued to advance our clinical studies and regulatory engagement and the pursuit of eventual approval for elements of EMS and mass as a software as a medical device product.
We look forward to providing further updates as we continue to progress our digital medicine strategy over the months ahead.
We are incredibly pleased with the progress of our pipeline and as we approach. The end of 2022, we remain highly focused on the execution of our long term plan and reaching key value driving milestones, which are anticipated in the upcoming year.
I'll now turn the call over to Sean Greenway, our CFO , who will discuss our financial results.
Thanks, Rob.
Thank you all for joining us today.
We will now turn to our financial results for the third quarter ended September 32022.
As of September 32022, cash and cash equivalents were $154 5 million.
<unk> to $133 5 billion.
At <unk>.
December 31 2021.
During the quarter the company regained compliance with NASDAQ listing requirements as well as completed financings through the use of our ATM facility.
In a public offering which brought in an aggregate of approximately $60 million in gross proceeds.
We believe these transactions not only brought in large lifesciences institutional investors into the shareholder register which displays their confidence in both our clear plan for value creation as well as our management team.
But also enhanced and strengthened the financial position of the company away from the vagaries of the macroeconomic risks of the current equity markets.
We believe that our cash and cash equivalents on hand positions us to accelerate and advance our proprietary pipeline into later stages of clinical development and will be sufficient to meet our operating requirements into the first half of 2025.
Our net cash used in operating activities.
Was $37 3 million for the nine months ended September 32022, compared to $38 million.
The same period in 2021.
Research and development expenses for the third quarter of 2022, or $7 8 million compared to $9 million for the third quarter of 2021.
The decrease was primarily due to external costs related to <unk> research program.
And a decrease in preclinical activities, which was offset by an increase in internal personnel costs as we continue to expand and how should we source and development capabilities.
General and administrative expenses were $9 2 million for the third quarter of 2022 compared to $8 2 million for the same period in 2021.
The increase was primarily related to issuance costs related to the cost public offering which closed during the quarter.
Yeah.
The net loss for the third quarter of 2020 to $16 5 million compared to $17 2 million for the same period in 2021.
Lastly, I wish to reiterate.
That we believe we are continuing to execute on a very efficient operation in terms of quarterly cash burn and compare to our largest peers in the space.
As we have previously highlighted during our second quarter of 2022 business update call. We intend to continue to conserve our cash.
Look for operational efficiencies in particular, our discretionary spending where we can.
While also focusing and prioritizing our support to our most precious resource and development activities directed towards our key value drivers.
I will now turn the call back to Rob.
I have some closing comments.
Thank you Sean.
As we have demonstrated the third quarter was marked by steady progress across our development pipeline.
We have a highly talented and deeply committed team here that we've continued to execute on our mission to be a leader in the advancement of novel treatments for brain health disorders.
This concludes our prepared remarks, and I would now like to ask the operator to open the line for questions.
If you would like to ask a question. Please press star one on your telecom telephone keypad now and he will be placed in the queue and you already received it.
Please be prepared to ask your question when prompted once again, if you would like to ask a question. Please press star one on your phone now.
And our first question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead Charles.
Hi.
Morning, Rob Sean Thanks for taking our questions and congratulations on a good quarter progress.
Couple of questions.
The first series on and then 120 and the second on our MD&A.
In terms of 120, thanks for the update but I'm wondering if you could provide any additional color with regard to enrollment patterns either in terms of patients beyond the first first one or a few and then the number of sites and if you could help us understand.
Whether or not there's good investigator interest in this study.
Yes, thanks, so much Charles and thanks for being here this morning with some questions.
Well, we haven't provided.
This should provide specific guidance on the number of patients that have been enrolled to date, but enrollment has progressed well beyond the initial patient dosing that we announced in.
In the third quarter.
Additionally, we fight type coming online have and continued to progress as well.
We have a very clear path.
I believe we will.
Listen we're all of our sites will be online in the very near term.
<unk>.
And in terms of Investor engagement, we have very frequent engagement with our investigative sites with the session monitors were actually conducting the delivery sessions.
Treatment sessions or investigational drug treatment sessions I should say.
And we've seen.
The enormous amount of investigator enthusiasm for this study so we are really optimistic about.
The enrollment and can continue to believe we will be on track to hit our readout.
Part of the country.
That's helpful Rob.
I could ask one follow up on 120 in that as well.
In this investigator feedback that you've referred to.
You have you heard any interest in other generalized anxiety disorder adjacency indications that you might consider looking at in the future that have even even higher unmet need.
If you will.
Yeah.
Yeah, we've certainly heard both from our investigators and also from from key opinion leaders, our scientific Advisory Board.
That was this.
This week.
Joining the extraordinary level of engagement and excitement about the potential and a broad range of psychiatric indications. So while we are certainly very keenly focused on getting to a JV approval first.
Comorbidity with with depression, it's something that is top of mind for all investigators and all.
All of the CNS.
CNS researchers and professionals.
Working in this area.
And we also as Joe.
We have.
Additional studies ongoing with University Hospital, Basel, including a study of LST and major depressive disorder, which we anticipate will happen.
Clarity on in terms of timeline results in the coming months so.
We're very excited to see the continued progress across other indications.
Certainly.
The opportunity we believe the historical data supports the potential beyond just generally guided this ordering there is certainly a massive need in JD.
But also in other therapeutic areas, where we believe there's a possibility of pursuing that indication of a later date.
That makes sense to me if I could hop over to four O two or our MDMA just quickly I'm wondering if you could provide some of your perspective on the mechanistic rationale that may differentiate R versus asps or racemic MDMA.
And then just a little more granularity on timing I think that you said phase one could be in 2023, which is a big.
A big range. Some I'm wondering if you think first half second half.
Okay.
Yes.
Dan Cohen, Chief Medical officer to comment on Mechanistically to add onto that.
Got it.
Yes, sure happy to and its excellent question. So when we look at the differential activity of Rs.
MDMA and of course, we're seeing existing a mixture of the two.
<unk>.
For dopaminergic.
Mackenzie makes it seems like the.
Largely dragging.
Both competitive activity.
I mean.
Gives me.
And some of the toxicity.
Hyperthermia and hydro <unk>.
<unk>.
That's been demonstrated repeatedly in animal studies.
Our MD&A and anti MRSA.
<unk> largely does start to energy.
Enantiomer of MDMA and responsible for the pro social and social perception and social communication effects of embracing the can be met so given that the core symptoms.
Ask me that we're targeting really relate to social cognition.
Social communication it seems clear to us, especially R&M tumors is the great one too.
Hi.
To target those symptoms.
The other thing Thats worth pointing out.
Paradigms currently for <unk>.
As an adjunct for psychotherapy rated enhancer processes like therapy.
We see our MD&A program it has been.
<unk>.
Different mechanistic actions, rather than enhancing second therapy for patients with autism spectrum disorder, we see the RMB and the program.
More about on drug effects in the real world proposed to the FDA.
On DNA there'll be better able to engage in social behaviors such communication.
And at better social perception, so it really is a different.
Kind of an entirely different targeting different paradigm different dosing schedule.
Yes.
Very good.
Yes.
Good timing.
Well Dan Thanks.
Yeah, and Charles to your question about timing.
At this stage.
It is certainly looking at it we have the ongoing study with University Hospital Basel.
We do have plans and we plan to initiate the study in 2023.
We would like to see some preliminary results and see at that alters our design or any of the outcome measures that we would.
Want to add or in our planned phase <unk> study and so we are going to have to be further refining those timelines and plans, we'll certainly communicate those.
Not just in future once more precise time is available.
And our next question comes from Francois <unk> from Oppenheimer. Please go ahead Francois.
Hi, Thanks for taking the questions that we've been on for Frank.
I had a question just on the RMA program.
I'm sorry, if I missed this but could you talk about the I think you mentioned, a one dose Egypt rns and.
Two doses of Rns can you just talk about the dosing strategy there any color there.
Yeah, absolutely. So this is a.
Random order placebo controlled double blind crossover study. So there are five treatment arms, including.
The placebo, we're testing doses of.
Excuse me.
Listen this is a 125 milligrams of racemic MDMA and SMA and 125 milligrams and 250 milligrams of <unk>. So it's 24 participants.
Five.
Investigational drugs or drug levels will be administered.
And Ah randomly ordered sequence in the same patients will get <unk>.
Intra patient.
Responses, both in terms of PK and PD.
<unk> never seen a mixture.
Great. Thanks, and then your MDMA study are you sharing at this time, what core symptoms of phase D going to be looking at like the cloud in the past social anxiety or any color there.
Yes, social anxiety is certainly the core feature of <unk> that we believe will.
It would be most of the lines mechanistically with with inventory to program and also.
The one where we are.
Focus based on the regulatory precedent in the history of research in this area. So that is our current expectation would be similar.
Similar endpoints as had been used in the past for some breakthrough program firstly.
As programs didn't progressed beyond pivotal studies, but we certainly believe mechanistically rdna represent a unique.
Ecology, and an opportunity to advance in this population to look at.
The historical endpoints and.
Historical indication.
Language as our primary target for treating core symptoms of that being principally social anxiety, which is the key.
Sure Todd.
<unk>.
Incentives.
Characteristics.
Communications.
Great.
Thanks, and finally, just in terms of the digital medicine products that you talked about are you going to be using any of these products with the ongoing trials how are we going to see any preliminary data.
Terms of patient journey or any of that.
Yeah, Great question. So we have ongoing studies.
Medicine products, the <unk> products in particular that we are developing or not.
In our phase <unk> study of <unk> 120, we do have ongoing studies with our digital medicine products.
Both looking at a number of molecules, including Academy and.
LST and Thats, where our collaboration with University Hospital Basel continues to be particularly important because given all of the ongoing research. We're able to include those digital medicine assets in some of those ongoing studies in University Hospital Basel II gives us a unique opportunity to.
Study, both the effects of LSD in various indications and for its mechanistic activity, but also to generate robust data set for our digital medicine products and <unk>.
Really really positive engagement.
With regulatory agencies that would put us in a position to truly advanced.
The same D approach.
Thank you thanks for taking my questions and congrats on all the progress.
Thanks, Tom.
Our next question comes from Ella <unk> from Roth Capital Partners. Please go ahead Oliver.
Yes, good morning.
Rob or Dan would you please.
Help us to understand.
What is your IP strategy that or MDMA.
Or.
Broadly speaking if you cannot be animals any specific.
Yeah, absolutely I mean, it's a great question and I think a lot of the discussion around intellectual property is.
It's fairly consistent across any of these molecules that have been.
Research in the past.
Certainly some some basic RMA is any molecule.
That we discovered clearly right in your maintenance any for a long time, the two <unk> have been looked at individually historically.
That said methods of using <unk> in indications.
We have data that we have generated that certainly gives us.
Got it.
Excitement about our IP approach both in terms of those methods of use but also in terms of.
Things such as Port formulations.
Her section with our digital medicine intellectual property and so.
As most of these molecules in essence outside of the.
Drug class and inside it when there is a molecule that has been studied historically and theres not composition of matter on the.
Baseline.
Do we build sort of a multi layered fortress approach to protecting our market share in that rely on marketing exclusivity from FDA having.
Having patents and we believe our differentiated both in terms of delivery.
Formulation of investments.
And then getting those patents are Orange book listed and utilizing the mechanisms available to us to.
Get stays for any potential generic entrants and ultimately.
Exercise any of the IP protection mechanisms both.
Inside immediately by FDA and.
Extra SBA.
IP protections afforded to us through the courts.
The ability to take action against any potential entrants at a later date.
Okay.
Would you be a little bit more specific of what.
Sort of information would come out from the PK PD trial.
I've been in Switzerland that would help you to design to phase one.
What is your hypothesis there.
Yeah, absolutely. So what are the are as.
Was that before.
The core focus of training courses.
Austin inspection that sort of social anxiety and this is something where we see the.
Pro social effects of RMA in preclinical models, we know the.
India Semic MDMA study in the clinic as described in the pathogen enhances pro social engagement and so.
Our expectation of our hypothesis here would be that.
And GMA would demonstrate that sort of pro social effect and healthy volunteers.
Important to highlight that.
I'll offer some spectrum disorder.
Clearly an indication where there is a great unmet need are no available therapies for the treatment of core symptoms of ASD.
It is one where it is not.
A disease like you would think of a.
Underlying.
Physiological condition that is totally distinct in terms of.
Physiology from healthy volunteers I know that Thats.
It certainly is an indication disorder that is again clinically relevant.
The impact on patient lives I want to be clear that we.
Certainly respect all of the implications of an ESG diagnosis diagnosis.
Unlike some indicators such as oncology.
Your indication.
Where you Couldnt, we couldnt understand the activity of <unk>.
Yes.
Apology drug in a healthy volunteer for clinical activity.
Believe that in the healthy ones here, if I'm looking at those pro social effects and by targeting the.
Social communication skills, which are the core focus.
ASD indication.
That won't be able to potentially see those exact kind of pharmacodynamic effects in healthy volunteers and we believe that based on this disorder in particular, there's a reasonable likelihood.
Read through effect that we can glean from our phase one study in healthy volunteers that with both inform the design and also potentially give us some.
Positive preliminary signs of optimism it at a minimum.
From the potential effects in between especially communication and nasty.
So do you believe that you might be able to based on the results from from bonds at all that you might be able to go into trial.
Trial in patients and in autism patients in Europe .
<unk> in the U S.
So certainly at some stage.
That's going to depend on regulatory discussions that we have with the regulatory authorities in the countries, where we potentially conduct our phase one study.
There is sometimes the ability to go into phase one studies in patient populations that is not something that we have.
<unk> two or <unk>.
That sounds too.
Tentatively.
But certainly we are looking to generate early signs of efficacy across indications as quickly as we possibly can.
The ability to get phase.
Phase one data.
Get PK PD data in healthy volunteers with RMB you may at two different doses should be quite informative in terms of how we designed our phase one program and the population, but are there and as you mentioned.
Going into the <unk> population.
By Phase II.
Yes. Thank.
Thank you so much Rob.
Okay.
And our next question comes from Patrick Tokyo from H C. Wainwright. Please go ahead Patrick.
Thanks. Good morning, just a couple of follow up questions on the 120 program first I'm wondering if you can discuss some of the similarities and differences between the recently published phase II placebo controlled investigator initiated trials LST in anxiety as compared to the mind med sponsored phase <unk> trial with am 120 per treatment of generalizing.
Alrighty disorder, and how much of a read through could we expect from this investigator initiated study to the phase III trial.
Absolutely. Thanks, Thanks, so much Patrick thanks for the question.
I'll ask Dan to comment on any initial response.
In terms of read through effect I think one thing that's really critically important to really understand here is that.
The aggregate of clinical information is particularly important as you look back to the last 80, roughly 80 years of research.
Sure.
On LSD, we've seen consistent responses and anxiety depression, and neurotic illness and this is in hundreds of patients in <unk>.
Over 20 studies.
Spot and so we then see modern high quality well work conducted in more controlled.
For your machines, so that confirms a historical effects I guess.
High degree of confidence and optimism.
One of the differences in terms of the phase.
The Iot conducted by Dr. <unk> <unk> study.
The number of elements that are a bit different but I wonder if it wasn't such ones as the endpoint in cheese, and so and they're starting to use the same training and guiding inventory, which is something that we believe from the literature.
It's quite relevant in terms of demonstrating that we are seeing reduction in anxiety symptoms.
The difference there is that is that a regulatory endpoint and so its utility in terms of being the basis for our regulatory applications for approval is just frankly not there we've had very productive discussions with FDA about where this would fit in the overall.
Development and evidence based and so on.
Because of the service.
Of course.
Tension between what we know can see clinically and the observations from investigator initiated studies such as the one you mentioned by Dr. Leakey.
And what's required by FDA, so that doesn't require us to use the Hamilton anxiety scale, which is the scale has been used historically for all analytics and Thats. What we are using in our phase <unk> study Dr.
Dr. <unk> study again as soon as the stay or like the strategy at the endpoint.
From the literature. We also know there is a high degree of response consistency, but while that gives us an incredible amount of internal comfort and optimism about the likelihood of success for our face to be clear.
Clinical trial.
It really is.
<unk> point to emphasize that the nuance here is what is required by FDA.
That means in terms of.
The evidence base that we have today in their eyes.
The other aspect I would touch on briefly is that we are.
From a design and statistical standpoint, what is a very.
Patient in patient number total number of subjects efficient clinical trial design that allows the 40 patients per arm across five arms for different levels of LSD.
And then 120 and so that yet because it is an extraordinary opportunity to see the dose response in a patient population.
We have seen historically when you've seen.
Dose response in healthy volunteers in terms of the.
Dynamic response to PK response, one of the interesting things about our PD response, and when we measure it by.
Overall drug a factor the misquote affect questionnaires that.
Being we're asking patients to or excuse me in this case, we're asking healthy volunteers.
To quantify something that is.
Supposedly inevitable, which is.
Paradoxical thing and so well ultimately important emphasize positive results, we observed a high dose and the highest is were testing 200 micrograms and that was the dose used in Dr. <unk> study. So what we saw at the highest dose we're testing a clinical response, it's critically important that we define the response on a regulatory and.
<unk>.
The population of interest in patients with generalized anxiety disorder and Thats, what we are robustly doing in our phase III trial. So it really builds on the historical phase one and.
Phase two investigator initiated studies that we have exclusive access to through Dr. <unk>, our collaboration with U H B.
But it really ties us all together in a phase III study with endpoint that would meet regulatory requirements. We believe.
With a design that gives us a very efficient look at how we demonstrate clinical activity.
The population of interest and ultimately with a clear path and a design that we believe will be leveraged into a pivotal program. So we designed the phase II <unk> study when the phase III study in mind I believe that the evidence generation in this study would give us a very strong argument dataset, a clear pathway to have negotiations with the FDA about it.
New program.
Yes, that's really helpful and just as a point of clarification just the decision to move ahead with the phase III <unk> study instead of moving directly into a phase III pivotal program can you just talk about.
How those as those discussions with the FDA had been ongoing.
Why the program wouldn't have been able to kind of progressed directly to a phase III pivotal following that investigator initiated trial.
Yes.
Any of the points that I, just mentioned sort of fee.
Scottsville basis, and I think.
Certainly we've had very productive regulatory engagements we've had.
We have great regulatory expertise I've had the good fortune of engaging with FDA and divisional psychiatry on numerous occasions right in terms of developing the psychedelic drug class and so that has given us.
Clarity in terms of what is expected I think you'd also look at one of our peer companies that compass pathways. Obviously, the other phase <unk> study and they are still conducting two pivotal phase III study so.
While in some disease areas.
You might be able to jump right into a pivotal study.
It Hasnt discussions directly with senior leadership and the vision of psychiatry at FDA about what's gonna be expected they've given the field a nice opportunity to go straight into phase II study. So remember most of the times.
Drug development have to go into a preclinical package and you're going to phase one and then go into phase III.
Two phase two studies, and then Youre able to go to a pivotal phase so they've allowed us to go directly into phase two.
Without doing some of that historical work, but they've made it very clear that they expect a comprehensive data package at the time of NDA submission.
At space.
It's not realistic into Chile.
No.
Naive.
Got that.
Our programs first clinical trial could be.
D or one of the pivotal studies is not something that we believe is.
A realistic pathway for any molecule that's going to be used in a broad population.
The indication that is highly prevalent and that's going to have a lot of exposure in the real world.
Yes that makes sense.
I had a follow up actually just the last one on this on the.
We're putting two earlier just around.
The comp 360 program and its a different drug different mechanisms.
Right.
PRD here, we're looking at anxiety, but.
Curious what the read through has been from the.
Those discussions there and with the pivotal program now getting underway.
And as well just just in terms of the number of patients that are having to be enrolled there in both the phase two b as well as the phase three program and presumably this is as well to build up.
A substantial safety database as well so I'm just curious on your thoughts on kind of how the FDA is thinking about kind.
Kind of pivotal programs with classic psychedelics, what read through is there from cop 360 and.
The number of patients that are going to be needed to build out that safety database.
Yes, another great question Patrick.
Wei.
There's we always try to rely on regulatory person regulatory precedent in something that's.
Particularly important in our field because.
Has.
To an extent that we have.
Broad leeway in terms of their discretion to the terminal.
Adequacy of a package and ultimately the approval of a marketing application and we think psychiatry has done a really nice job.
Balancing the ability to.
But.
Allow enable research to progressive.
Pace, but also.
Require robust is that something that as well.
And Curt I came into nine men beginning of 2021, something that from day, one and from the first pre IND engagement.
We had with FDA, which actually predated my employment, which was conducted in December of 2000.
2020.
On closely with Dr helping widely.
From that very first engagement our approach has been to plan for a comprehensive research and development programs. We believe that that builds credibility both for our organization and those are the.
But the profile of both mine that in the program with FDA and broadly with the entire entire community stakeholders and so.
Our expectation is that we're going to be doing a comprehensive pivotal program now one of the things that is certainly.
Important to emphasize is that strategy and geographic focus in the number of.
Countries in which the trials being conducted in an ultimate marketing application in the sequencing of that also has an implication in terms of patient sizing the design of clinical trials, so while it's gotten.
I read through of and clarity on what the Phase III program is we don't have the regulatory minutes or knowledge of the discussions that have been had with FDA or other covenant authorities for instance in European Union that would potentially informed.
How compass for instance, with thinking about their clinical program.
Certainly we anticipate that to conduct two pivotal clinical trials of <unk> 120 in generalized anxiety disorder.
Again.
<unk> regulatory discussions.
I believe we have a good degree of clarity in terms of the overall.
Overall expectations those will be firmed up as we complete our phase <unk> study based on the evidence we generate there and.
Based on continued regulatory negotiations.
We will either end of phase two meeting certainly try to have.
Greater clarity on exactly what our pivotal program would be but.
Whenever there's a presence establish we certainly pay very close attention and trying to unpack. The rationale I think we would we would approach.
A few things a little differently.
Believes that and then 101 is going to have a.
Multi month, the fact that we wanted to demonstrate what happens on.
Over the acute coarse sand over that.
Longer duration, we've seen from Uhm study.
Many months of production and anxiety symptoms and so we're highly confident in that.
Many months.
Response level and that's going to inform how we think about.
The core pivotal trials and how we think about other trials that maybe required either as part of the phase III package or the post approval clinical trial that would inform what happens on the re treatment and the ability to.
Maintain or retreat of potential relapse because these agents certainly are not going to be sure. It is in all patients and that would be an unreasonable expectation. So we need to develop a strategy for the long term, how we can safely and effectively Australia acute.
The acute situation, but also.
But in effect over over a period of time.
Yes, that's really helpful. Thank you so much.
Yeah.
Thanks, Patrick.
Our next questions come from prepare mono Cherry from eight capital. Please go ahead from here.
Thanks, and good morning, Thanks for taking my question.
I noticed you mentioned some of the studies ongoing.
<unk> side of things and <unk>.
Your thoughts on how that will wrap around into whether it's.
Ahead of your phase III program or if that's something that's.
<unk>.
Basically be in the package.
And submit for a potential rems just trying to understand when not.
That data on those studies.
Kind of add value to the programs and how you think about the readouts there.
Yes.
Really important.
And to emphasize that there are two discrete.
<unk> ways by which products are approved and thanks. So much for the question I should say first.
We obviously engage Peter in the division of Psychiatry for the development of our drug product candidates and for digital AMD products.
We're engaged with CVR age and are leases that are being developed as sandy products. We're in.
<unk>.
CVR H, which is the device division of abuse.
Any devices, including CMT products.
We've had.
Really productive engagement, including with.
With joint meetings with senior age and Cedar, which has informed our overall development strategy. Both in terms of the digital medicine products independently, but also our longer term thoughts and strategy about how digital sandy products could be.
Integrated and married up with our drug product in particular, and then 120 and so.
We have not given.
Yeah.
Gotten to a point in those negotiations or regulatory discussions where we can say.
There is a precise moment in time, where we would.
Include those two are trying to have them labeled together from a regulatory standpoint.
But certainly we are making rapid progress on the sandy device.
Right side of the equation and certainly have a view to incur.
Include those and integrate those with our drug development strategy as we enter our pivotal study so the sequencing of how those could be used whether it's.
Together labeled separately, but used together in a real world delivery setting.
Subject to both of those products being ultimately approved for marketing.
Or whether it's a sequenced approach to getting them co label that that's something that that sequencing is what is top of mind and top of our regulatory discussions at this point, but something that we absolutely intend to do in the long term is to have our digital products.
Integrated with the delivery of our drug products and <unk>.
In so doing.
Trying to address some of the key gaps in the delivery of drug class, though.
Things such as the high labor intensity that is required in clinical trials and the delivery of dosing session.
Scalability.
Sorry.
Article from Brooklyn address commenting on the results from Columbus is one of the things we felt was.
Particular opportunity when we think about scalability, Dr. Matt just mentioned.
In the real world, how tightly controlled clinical delivery.
Both in terms of psychotherapy and the labor intensive observation is very hard to scale them.
We agree with that view.
We don't agree with some of the other point today, but we would certainly agree with the view that that is something that needs to be addressed and.
We believe the right approach to address that is by adding tools that can innovate and can allow more efficient delivery of the <unk>.
Driving so if we were to say.
We're going to just.
Try to scale.
A multi hour highly degree to individuals with medical degree sitting in a room with a patient that's going to be very difficult, but if we can come up with ways to safely.
Make that process more efficient make observation more efficient.
Make time of observation on your clinic more efficient and more personalised. These will be meaningful improvements that we believe would substantially.
Hence the drive uptake in would be.
Let me unlock the potential to deliver a second dock drug class in what we believe is.
Our aim with our CMP products.
Got it so that's kind of.
On top of mind in terms of paying down the sequencer in terms of.
The anticipated results around those <unk> programs in use.
Is that something that you anticipate in the coming year any of this.
Studies are debated.
Yes.
I'm getting some data as to kind of applications.
Hello.
Apologies.
We certainly anticipate that across the digital programs, we have in particular of the M. S. M. S. P.
Platform studies that we would do.
I'll be making announcements as we progress those programs. So we haven't given a precise quarterly guidance for windows data analysis would be.
We will have some.
More to announce in the near term and are very excited to do so I think when we make that announcement it will be with a lot more with a lot of clarity in terms of the.
The scope of the potential.
The data, we've been generating and exactly how that.
Dovetails, both with our product candidates and with other.
Substances.
But have <unk>.
Perceptual effects that have.
It had been approved by FDA and that.
Require an observation period. So we believe our clinical research and some of the things we will be announcing over the coming months would be very.
Very clear how it leverages our current research with approved.
Psychiatric therapies, and how that could be a great analogy for how we can scale. This.
The utilization with our <unk> product candidate in particular.
How do I look forward at the bottom and just on the.
And then 120 I know you've talked about some of the wrap around whether it's some of the digital health assets or things.
Things that you guys can do to differentiate your offering I want to ask about <unk>.
Trip Stopper I know <unk> was I guess in an investigator initiated trial.
In the past that was completed is that something that could be paired with the.
With the kind of delivery that you guys think about whether it's for the Rins program down the mine or whether data for that could help in your.
And filings eventually down the line.
How do I think about that and how that.
How that folds into them on 'twenty program.
Yes. So at this point, we don't have an intent to have a co labeled product with.
Sachin <unk> receptor antagonist in the here in the U S. <unk> got approved and the answer is but everybody by case pharmaceuticals.
There is certainly.
No.
Potential that we could at some point in the future.
Pursue further research then mechanistically quite interesting and important to understand if there is.
<unk> ability to abruptly terminate.
The conceptual effects of 20 other second dogs that are there certain agonist, but.
Is that would require in order to have that as a direct directly targeted for that user would require clinical research in a label expansion or an initial labeling in the case of marketing applications for <unk>.
At this point, that's not something we're pursuing.
As we get more data we obviously.
Develop our strategy and research development plans accordingly, as we have seen continued progress in the clinic and we get more data.
That could certainly inform future direction, but at this stage.
It is an interesting research study, but not for them then we have a product candidate we are actively developing.
Okay, well, thanks for the insight there and congrats on the continued development progress I appreciate the level of detail here.
Thanks, so much.
This concludes the question and answer portion of the call I'll now turn the call back over to Mike <unk> CEO , Rob barrel for closing remarks, Rob.
Yes. Thank you operator, and thank you to everyone who joined us today.
The other the rest of it for the great questions.
I'd also like to thank our entire team has said we have a highly talented and dedicated team here at <unk>.
We're very grateful for their incredible efforts to advance our research and development programs.
Our investors and all the people who have been supportive to my met along the way and continue to be supportive as we execute on our strategy to provide meaningful impact.
And the team and the development of novel treatments for brain health disorders.
Just wanted to thank the investigators and study participants and their families. This is oh.
We're doing research in populations that have significant impact isn't a massive unmet medical need and we believe we can have a meaningful impact in those populations and it can't be done.
Without the dedicated researchers.
The patients who volunteered their time and go through all of the extensive work in a clinical trial to conduct these studies so.
A very direct thank you to all of them are very excited to continue our steady and we're very excited for the year ahead. So thank you all for being here today, and we look forward to providing further updates soon.
This concludes today's conference call. Thank you for attending.
The House has ended this call goodbye.