Mind Medicine (MindMed) Inc. Q1 2023 Earnings Call
[music].
Good afternoon, and welcome to the mind Medicine first quarter 2023 financial results and corporate update conference call.
Currently all participants are in listen only mode.
Call is being webcast live on the investors and media section of my Meds website at <unk> Dot Seo and the recording will be available after the call.
For opening remarks, I would like to introduce Rob burrow CEO of mind Med. Please go ahead.
Okay.
Thank you and good afternoon, everyone.
Welcome to our first quarter 2020 financial results and corporate update conference call.
The press release reporting our financial results is available in the investors and media section of <unk> website.
Our quarterly report on Form 10-Q for the quarter ended March 31 2023.
Filed today with the Securities and Exchange Commission.
Joining me today is Sean Greenway, our Chief Financial Officer, Dr. Dan Carlin, our Chief Medical Officer and.
Dr Community, helping widely our executive president.
During today's call, we'll be making certain forward looking statements, including without limitation statements about the potential safety efficacy and regulatory and clinical progress of our product candidate.
Financial projections and our future expectation.
Fans partnerships and prospects.
These statements are subject to various risks such as changes in market conditions.
<unk> is associated with research and development regulatory approval processes.
Ascribed in the filings made with the SEC, including the most recent annual report on Form 10-K, and quarterly report on Form 10-Q.
Forward looking statements are based on the assumption.
Estimates of management statements, you made including the non recurrence of the risks and uncertainties described in our filings made with the SEC or other significant event occurring outside of normal course of business.
You are cautioned not to place undue reliance on these forward looking statements, which are made as of today may four 2023.
<unk> disclaims any obligation to update such statements, even if management's views change except as required by law.
I would like to begin by reiterating our deep commitment to advancing our organization delivering new life changing treatment option for the many individuals living with brain health disorders.
And as we pursue our strategy to bring our lead product candidates to market. We believe we are laying the foundation to create lasting value for our shareholders.
And the first few months of 2023, we continue to make steady progress across our pipeline and we are well positioned to execute on our key priorities are reached multiple milestones throughout this year.
Putting data readouts from our phase <unk> trial, and $1 20 for the treatment of generalized anxiety disorder, JD as well as from our phase Iia proof of concept trial of repeated low dose and 120 and attention deficit hyperactivity disorder or ADHD.
Additionally, we expect to initiate the first clinical trial of unemployed to later in the year.
Before we dive further into our R&D and financial update I'd like to highlight the recently presented positive top line data from the phase II double blind investigator initiated trial evaluating <unk> in the treatment of major depressive disorder or <unk>.
This trial was led by Professor <unk> and Dr. Miller, our collaborators at University Hospital Basel UHD.
Most of the hospitals psychiatry and such.
As a reminder, we have exclusive global rights to data compiled and patents associated with the leaky labs research evaluating license other psychedelic compounds.
This includes data from numerous completed and ongoing investigator initiated trials in both healthy volunteers and patient population.
Our collaboration has been particularly impactful by demonstrating and reinforcing the clinical potential of our drug development pipeline.
Topline data from this investigator initiated trial demonstrated significant rapid durable and beneficial effects license guide, which potentially mitigate symptoms with MTT.
Patients in the study received the 100 microgram dose with likes of Jive N. The first dosing day with 200 microgram dose of life's Jive N. The second dosing day, which was separated by four weeks.
And active small dose of 25 microgram placer Jive was used as a control.
The trial met its primary endpoint at six weeks, which was measured by the change in clinician rated inventory of depressive symptomatology for Ibs C scores.
Further the statistically significant benefit was maintained at 16 weeks, which underscores the potential long term benefits of license.
Data from the secondary endpoints were also encouraging any investigational drug was generally well tolerated.
Given the high degree of Comorbidity of MD <unk>.
The positive results and clinical activity of Leiser giant are particularly relevant to our it and then 120 program.
I'll now turn to updates on our R&D programs, starting with our lead program in the 120, a proprietary pharmaceutical optimized form of life's a giant titrate on development for the treatment with JD and ADHD.
J D as in often debilitating mental health disorder associated with excessive anxiety and persistent worry which can lead to significant impairment social occupational another functioning.
With very little innovation focus on J D.
There has been a noted increase in the incidence and prevalence individuals diagnosed J D. In the U S and Europe over the past several years.
Additionally, the number of patients who are not adequately treated by available therapies is also increasing.
This is a result of the low rate of formation and multiple safety and Tolerability challenges with Ssris, often arise anti psychotics benzodiazepine.
The research, we've conducted with patients and healthcare practitioners in the U S and Europe caused us theres a significant demand for our new pharmacological glass offered faster more profound and more durable efficacy responses as well as favorable safety and tolerability.
This is particularly true in the segment of patients who despite having exhausted all available options continue to experience intolerable anxiety.
Given the need for new treatment options. We are extremely encouraged by the growing data, which supports the therapeutic potential and then more in 'twenty.
Patient dosing in enrollment for our phase III trial in <unk> is progressing well across our 20 active sites and we reiterate our expectation of reporting top line results in late 2023.
The trial plan to enroll a total of 200 participants who will receive a single administration of up to 200 micrograms, and then 124 or placebo.
The primary objective of the study is to determine the reduction in anxiety symptoms for up to 12 weeks. After a single administration and then 120 across five treatment arms with a primary endpoint measured at four weeks post dosing.
The results of this trial will dose selection development strategy for it and then 120 <unk> as well as deepen our scientific understanding of its clinical effects underlying functional mechanisms of action.
As mentioned we are also evaluating and then 120 for ADHD, We expect to report top line data for our Phase Iia trial in late 2023.
Phase Iia trial is being conducted in collaboration with the University Hospital Basel in Switzerland in Maastricht University in the Netherlands and is designed to evaluate the therapeutic utility of <unk>.
The low doses and then 120 adult patients with ADHD.
Notably this is the first study in which and then once <unk> has been administered outside of the clinical study.
To date, no SCE had been reported suggesting the real world potential of this treatment regimen as well as demonstrating our ability to deliver it and then 120 with innovative dose and frequency combinations.
In this trial, we expect to enroll a total of 52 participants who will receive a 20 microgram dose and then 120 or placebo twice weekly for six weeks.
The primary endpoint for the study are mean change from baseline in ADHD symptoms as assessed by the ASR after six weeks of treatment.
This proof of concept trial as a component of our broader comprehensive I mean, 120 clinical development strategy, which seeks to explore both session based administration harnesses perceptual effects of <unk> agonism.
David repeat administration regimen harnessed, the neuro pharmacological effects of the current short term magnesium.
The innovation and then 120 and session based delivery approach is driven by its mechanism of action as a potent <unk> receptor agonist, which leads to profound sustained psychological effects.
We believe and then <unk> will be delivered to the single dose pharmacological intervention, but will only require occasional administration.
We recognize the potential challenges in commercializing a product with such a revolutionary delivery profile and has embarked on a robust pre commercialization plans seeking to educate all external stakeholders of the clinical and economic value of the NIM 120.
This is why one of the key priorities we are advancing in 2023.
Developing innovative market access strategy.
Document the clinical and socioeconomic burden of J D in ADHD.
The generation of health economics, and outcomes research data required to build a superior value proposition for our product candidates.
As we progress our pipeline and we look forward to providing greater clarity on the commercial model and path forward for each program to maximize the reach of our novel product candidates.
As a reminder, with respect to our intellectual property strategy. Our patent portfolio includes 26 pending U S applications and 12 pending PCP applications.
These include applications covering compositions dosing dosage formulation and methods of treatment among others projected exploration dates beginning in 2041.
Additionally, we continue to retain all rights to our product candidates and are aggressively protecting and expanding our intellectual property portfolio as part of our comprehensive market protection strategy.
Now I would like to turn and then flow to or our India, which.
<unk> and Anti-american MDMA with potential pro social effects and a favorable tolerability profile.
And then <unk> is in development for the treatment of core symptoms of autism spectrum disorder, or ADHD, which is characterized by atypical social communication and interaction.
Repetitive patterns of behavior and restricted interest.
Despite a significant and growing prevalent there are no therapies approved to treat the core symptoms of ASD.
<unk> is a synthetic molecule. It is often referred to as in packaging because it is reported to increase during the connectedness and compassion.
R&D may stop the increased levels of serotonin and to a lesser extent norepinephrine and other neuro transmitters in the brain, resulting in fewer lines have increased their stability and their personal emotional warm.
Preclinical studies of RMA demonstrated its acute pro social and pathogenic effects.
Diminished dopaminergic activity suggests it can exhibit less stimulant activity neurotoxicity, hyperthermia and abuse liability risk compared to racemic MDMA or the asked and answered.
Our anchor and then forward to us to demonstrate its ability to enhance social engagement and interaction rather than having a sedating or blunting effect, which is often a result of currently used off label medications and the ASD population.
Accordingly, a late breaking abstract on the preclinical study of <unk> in our model lumpy. It's.
It's been accepted for presentation at the 2023 American Society of clinical Psychopharmacology annual meeting.
Being held in Miami Beach, Florida for May 30 June 2nd.
With even further preclinical evidence to support our approach we are extremely excited to initiate our phase one clinical trials and then part two later this year.
This trial is intended to characterize the tolerability pharmacokinetics and pharmacodynamics of <unk> 402, and we continue to explore all opportunities to generate early signs of efficacy as early as possible in development.
Such data can be generated both in their typical healthy volunteers and in otherwise healthy individuals diagnosed with ADHD.
In parallel to our research collaborations University Hospital Basel in 2022, we initiated and are currently enrolling healthy volunteers in a comparative phase one pharmacokinetic and Pharmacodynamic study of our Ash racemic MDMA.
This study is designed to evaluate the tolerability pharmacokinetics acute subjective physiological and endocrine effects of the three molecules. We believe its successful completion will accelerate our understanding of the pharmacological profile and then part two as we advance into later stage clinical development.
Lastly, moving to our digital medicine update.
Our drug development strategy as closely complimented by a suite of digital medicine program, the potential to facilitate adoption use and access to our product candidate.
By refining the techniques used to capture model in NAFTA autonomic behavioral outflow other correlates to electric.
And to improve the experience of clinicians and the outcomes for patients and the delivery of psychedelics other perception altering substances.
Our digital medicine programs are oriented toward applications during two primary clinical period.
Activity during a treatment session referred to entrust session and activities between treatment session referred to as intersection.
Each digital Medicine program consists of a platform it became separate underlying component.
Some of which we anticipate will be within the scope of Fda's definition of medical devices.
Others, which we anticipate will not be regulated as a medical device.
For the medical device products, we intend to engage with the FDA and other international regulatory authorities to receive guidance along the development pathway towards the potential submission regulatory clearance or approval.
The ultimate goal of our digital medicine projects is to develop applications that overcome fictional point of care delivery to encourage user adoption across patients providers and payers.
Overall, we are very pleased with the progress to date.
As we advance our key clinical programs and execute on our corporate objectives. We continue to further strengthen the leadership of mined metal.
We're excited by the recent addition of Mark Sullivan, Chief Legal Officer Corporate Secretary.
Mark brings extensive legal and public company life Sciences expertise with a strong addition to our executive team.
We believe market experience insight and guidance will prove invaluable as we progressed over the next stage of evolution.
I'd also like to highlight that as we approach our annual meeting in June we are very excited by the potential of adding <unk> to our board.
Dave brings invaluable insights from his 35 years of experience in the biopharmaceutical industry, including his service as CFO of two S&P 500, pharmaceutical company insight and Celgene.
Dave has also previously served on the board of GW Pharmaceuticals before its acquisition by jazz Pharmaceuticals for $7 2 billion.
It serves on the board of CGM, which recently agreed to be acquired by Pfizer for over $43 billion.
Dave's domination represents our ongoing commitment to board refreshment and ensuring we have the optimal mix of experience and perspective to the boardroom to help the company create value.
I believe Dave involvement as an endorsement of the incredible people and organization, we have built at <unk>.
As well as the potential impact of our products on the millions of individuals suffering brain health disorders.
I'd also like to express the board's gratitude to bridge it makes who notified us that she will not stand for reelection at the annual meeting for her years of service to the early growth of the organization.
Now is the time to radically transform how we treat brain health disorders, and we are deeply committed to realizing that potential for change.
With that I'll now turn the call over to our CFO , Sean Greenway to discuss our financial results John .
Thanks, Rob and thank you all for joining US today, we will now turn to our financial results for the first quarter ended March 31, 2023 as of March 31, 2023, our cash and cash equivalents totaled $129 4 million compared.
Compared to $142 1 million as of December 31, 2022.
We believe that our current cash and cash equivalents on hand positions us to accelerate our preparation for moving quickly into our pivotal studies for our lead program.
120, and will be sufficient to meet our operating requirements beyond our key development milestones in 2023 and into the first half of 2025.
Our net cash used in operating activities was $13 3 million for the quarter ended March 31, 2023, compared to $12 9 million in the quarter end March 31 2022.
Research and development expense were $12 6 million for the quarter ended March 31, 2023, compared to $10 2 million for the quarter end March 31, 2022, an increase of $2 4 million.
The increase was primarily due to increases of $2 $9 million of expenses related to clinical research for the MMO <unk> 20, <unk> study <unk> 9 million in expenses related to our <unk>.
Two program and <unk> 2 million and internal.
Internal personnel cost as a result of increase in research and development capabilities, which were offset by a decrease of <unk> $7 million in expenses related to our <unk> program and a decrease of <unk> $9 million of expenses in connection with various external R&D collaborations.
General and administrative expenses were $8 3 million for the quarter ended March 31, 2023, essentially flat compared to the same quarter a year ago.
Our net loss for the three months ended March 31, 2023 was $24 8 million compared to $18 5 million for the same period in 2022.
Lastly, I wish to reiterate that we are continuing to execute on a very efficient operation in terms of quarterly cash burn and head count when compared to our peers in this space.
As we have highlighted during our prior business update conference calls, we intend to continue to be thoughtful with our cash while also focusing and prioritizing our support for our most precious resource and development activities directed toward our key value drivers more specifically, we will review our discretionary expenses when a constant basis.
To ensure that we are seeking to capture value from operational efficiencies, where we can.
I will now turn the call back to Rob who will provide some closing comments.
Thank you Sean.
We remain laser focused on driving our key programs forward, which includes advancing <unk> and then 120 product candidate JD in ADHD phase III clinical Readouts later this year as well as initiating our first clinical trial of <unk> hundred two.
Additionally, our early R&D activities are progressing on our collaboration with the University Hospital Basel continues to offer the opportunity to generate early clinical evidence to inform our pipeline progression.
I also want to extend my sincere appreciation and gratitude to the foundational work has brought us closer to advancing novel treatments for brain health disorders.
In particular, I would like to thank our highly talented and deeply committed team here at mine that.
Our investors and the many people who have been supportive along the way.
Our research participants and their families.
We are working tirelessly to deliver on our mission of transforming the treatment landscape for the many individuals living with brain health disorders, who are underserved by today's available therapies.
Finally, I'd like to remind everyone that the purpose of today's call is to discuss our first quarter updates the progress of our business and we will not be addressing matters related to our annual meeting.
We encourage all of our shareholders to review our definitive proxy statement, which has been filed with the SEC on SEDAR and the visit Www dot protect mind med dot com updates pertaining to our proxy campaign.
With that I'd like to thank you all again for joining today and I'm happy to take questions.
Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press star followed by one on your Touchtone phone you will hear three telecom technology a request in your questions will be pulled in their to their received should you wish to decline from the polling process. Please press star followed.
By two.
If you are using a speaker phone please lift the handset before pressing any keys one moment. Please for your first question.
Correct.
Your first question comes from Charles Duncan Cantor Fitzgerald Charles Please go ahead.
Okay, Yes, good afternoon, Rob Sean Thanks for taking my questions.
And also thanks for all of the clinical trial design details, particularly for 120 in ADHD and 402 that was that was helpful.
I do have a couple of questions. So regarding.
And then 120 <unk> I'm wondering with the sample size of call. It 200.
Five arm so about 40 per arm I'm wondering if you could frame what you would like to see out of that study in terms of some of the effect size is and if you anticipate a full kind of dose response or would it be really bookended by placebo versus the higher highest stares. So.
Tell us what you think would be good out of that or 20 or out of that 120 study in <unk>. Thanks.
Thanks Charles.
Thanks for the question and for joining us today.
With respect to the size and the design of the Phase <unk> study. So as you mentioned 200 patients, we anticipate enrolling across five treatment arms, which for everyone.
Reminder, as doses of $25 50 to 100 or 200 micrograms or placebo patients received a single dose and then followed for 12 weeks.
The study was designed in such a way where it is.
Statistical methodology, we're using really gives us.
Power across the entire spectrum. So we benefit from the response across the travel segment.
That methodology developed at Novartis and this isn't that.
Ultimately two parts statistical task one that.
We will test whether or not there is any treatment response at all in the second part of the test as we nominate candidate profiles, which.
Would reflect exactly what youre getting to in terms of the type of dose response, the magnitude that's actually the slope in the shape of that dose response curve.
In terms of the maximum magnitude we anticipate seeing.
We've really designed the study so that we can.
Characterize the effect size and power of a phase III program.
But our expectation was really set to demonstrate just anything are at or above the standard of care is the.
Standardized effect size for most of the available analytics.
Round three fives, whether you look at <unk> or benzodiazepines and so even if we saw response of that magnitude, we would anticipate seeing significant outcome.
We certainly want to see an improvement over the standard of care in bleach.
As an opportunity to do exactly that so in terms of expectations.
You want to fully characterize the response across.
The doses, both acutely and in terms of durability I think it's particularly important to emphasize that by looking at multiple doses that we believe would be at or above.
Within the therapeutic window.
That actually gives us important insights both in terms of the magnitude and durability of response at those different doses and the subsequent therapeutic doses as we anticipated.
The design has been again to robustly power and detect a difference but also to make sure. We're characterizing adequately acute and durable response to power and design a phase III program.
Okay. So that's helpful. Rob So we should not consider.
That this is a pivotal program our pivotal study and judge its outcome based on that debt.
Whether or not it's viable to help you move forward into phase III correct.
That's correct it would be very much premature to consider.
A pivotal study it is certainly an important part and we've even seen.
Presentation by Representatives that FDA at recent conferences, the <unk> a few weeks ago about the importance of demonstrating dose response and again I think we as a.
Sector setting this drug class really need full comprehensive information.
And datasets before we go into a pivotal program is going to be very efficient very clean design as we as we anticipated today. So.
It has been the study the phase II study has been designed to give important insight in that design characterize the response in this population which has not been.
The scale of this magnitude and really no studies to date that we're aware of have looked at a comprehensive explanation of dose response, so that is.
The intent of the study and ultimately we believe that will give us.
Additionally, additional support for our ultimate clinical package sooner is an NDA, but also will help us be very efficient phase III design.
Very good and then one quick perspective builder on the recent CPT codes CPT three code I'm wondering if you could provide your perspective on how you think the Ami Ami <unk>.
<unk>.
Its approval.
First step approval to establishing CPT code to enable.
Really intermittent therapy, then that involves both a draw again and a therapist. If you have a perspective on that and how that may actually reduced risk of.
Not only approval, but commercialization of these types of drugs.
Yeah. Thanks, Thanks, Charles I'll turn it over to Dan Cohen, our Chief Medical Officer, Nick to respond.
Hi, Charles.
Here is a really important question, obviously, something we've been paying a lot of attention to is progress has been made in that and that CPT III code as folks listening will know that.
Level three codes are used for experimental and new services that have not yet.
Perhaps a substantial body of evidence behind them yet we think this is.
An important step in the right direction, and we applaud composite mats for the collaboration on getting to that point.
Also note as well.
That code is specific to too.
Services in general.
We will apply to everybody across the board.
In many cases through existing.
Parallel.
Such as.
<unk> administration, while there is an existing.
It's a little.
A little too cozy.
G code specific to the services. Many if not most commercial insurers are actually being built for services like this under existing level one so.
So there are a number of pads to cutting success.
And I think through some facial recognition.
I mean, the CPT is important.
<unk>.
One <unk>.
Certainly on the process to having a fully robust cutting system that will cover all forms of.
Third party payers, including government and non governmental commercial payors.
That's helpful. Thanks for the added color again, thanks for taking my questions.
Thanks, Frank. Thank you. Your next question comes from Brian Abrahams RBC capital markets. Brian . Please go ahead.
Hey, good afternoon, thanks for taking my questions.
Two from me I guess first off on <unk> as you think about how you might interpret the upcoming phase II data I'm curious your latest thoughts on how to find the best dosing window dose levels, that's going to make that are going to maximize the benefit risk profile and I guess.
Im curious if multiple doses are effective would you move forward with two doses or more in phase III and I guess, how might you think about steering, which dose might be appropriate for which which patient.
And balancing efficacy with safety.
Yeah.
Yes, thanks, so much for the question Brian .
It would be a little bit premature to say specifically.
We have.
Many thoughts about how we generally think about safety and efficacy and the balances benefit risk as we design a phase III program, what I would say is that we are.
Very much intent on being extremely efficient and clean in our study design and want to make sure that we have as directly with patent decision of a program as possible.
As we look to the data from this study.
It is important to note one of the things is particularly exciting about drugs. We're working on and 120 in particular is that the acute administration seems to drive.
And durable response.
And because of that it does offer some advantages potentially in terms of the risk profile. So we wouldn't expect sort of physiological risk to persist like what if youre, taking a daily medication. So we'll certainly be monitoring outcomes, both efficacy and safety for the duration of the 12 weeks.
We want to make sure that the.
Whatever dose we select to move forward into phase III as both responsive in terms of efficacy, but also well tolerated and we anticipate would be safe as we get into a larger part of the development program.
With all that said too I think it's really it's really important to note that.
Based on the historical FX sizes, including the fact that as we've seen from investigator initiated studies, while they are preliminary rate apart or up to a standard support.
The evidence for an approval necessarily.
Does effect sizes are quite large and so we would anticipate that even if we were to choose a dose with.
Better better tolerated, let's say just theoretically or.
Yeah.
Had a similar response.
We would be able.
To have a high degree of confidence I think basically historical effects as if were ultimately able to replicate that that the size of the phase III program would be adequate giving us plenty of patients to be able to demonstrate statistical difference if we see a COO.
Country meaningful responses, we anticipate.
That's really helpful. Thanks, Thanks, Rob and then I guess secondarily with regards to the 402 program.
You mentioned the study that's going to be looking at at racemic, MDA MD&A and the enantiomers.
In healthy volunteers in collaboration with the U H B I was wondering if you could elaborate a little bit more.
That study, what specifically you're going to be looking for in terms of the.
To better understand the pharmacology.
Parameters you'll be.
Flooring and when we might report data there and I'll hop back in the queue. Thanks.
Yes. Thanks, so much that so in terms of the study design. It's two different doses of <unk> 125 to 250 milligrams single dose of SMA and single dose racemic MDMA and this is a patient all of the patients would be cross over and receive these.
Different treatments in so much as 145 milligrams of <unk> and the <unk>, that's being administered here. So in terms of the outcomes that we're looking to.
Largely the pharmacodynamic outcomes so.
Overall drug effect in terms of intensity and duration.
We are conducting as one of the primary outcome measures or I should say.
These lab disconnecting.
The five dimensions of Ultrashape conscience to fight the ASC scale.
It's also investigate.
Functional perceptual activity.
Between <unk> and racemic MDMA should we be looking at a number of autonomic effects.
<unk> effects of.
Of course, characterizing pharmacokinetics and looking at other endocrine effects levels of oxytocin Proacting cortisol. These are pricing so many of the <unk>.
Halfway to that have been implicated in the activity of our ore racemic MDMA to characterize that response with two different doses and ultimately seek to inform how we advance our own phase one program and further into the clinic in phase two and beyond.
Got it thanks, so much.
Thank you. Your next question comes from Francois Brisbois Oppenheimer Francois. Please go ahead.
Alright, thanks for taking the question.
Some of the progress here just a couple here in terms of the recent.
Hospital Basel study that you mentioned there are just so maybe if you can remind us the differences here so multiple doses.
The comparison is not to a true placebo and obviously a different indication, although similar comorbidities and then.
So maybe just talk about the differences and how this could be a read through towards your study and any thoughts on patients keeping them on ssris versus wining them off and what they can do.
Great. Thanks, so much Greg.
So in terms of study design and this is an investigator initiated study looking at the impact in patients with major depressive disorder patients in the active arm receive two different doses that were separated by a month first was a 100 microgram dose. The second was a 200 microgram dose, which again was separated by four weeks.
The control group in this study was administered at 25 microgram dose.
Both of the treatment days, but the dosing session. So it was not an inert placebo, but we still did see a statistical and clinically meaningful differentiation between the response to those two doses. So we saw a three six points.
Point improvement.
And the <unk> score, which is the inventory of depression symptomatology score six weeks after administration of the first treatment session for the low dose arm and we also saw a 12, 9%.
From a nine point improvement on the Ibs C and D.
The higher dose of 102 hundred microgram dose arm.
Those effects remained durable out to 16 weeks and we saw a number of encouraging secondary endpoints in the study so.
Overall, I think we view it is particularly impactful and important given the.
Relevance to depression.
Of course.
<unk>, an indication where there is a huge growth in incidence and prevalence.
One where we've also seen historical evidence of activity and steer leiser dried.
But it is also particularly important to note that there's a high degree of comorbidity between generalized anxiety disorder and major depressive disorder, both in terms of <unk>.
Nonstick overlap, which we think is incredibly high but also in the number of patients.
Pregnant prevalent to diagnosing some roadblocks in the population. So we think it's both relevant to our JD program, but also opens up an opportunity we've seen historically strong consistent responses.
Many studies in hundreds of patients with <unk>.
<unk> and anxiety and depression, and other neurotic illness, and so this seems as consistent with the data we reported an anxiety back in 2022 again, demonstrating a strong statistically significant response after acute administration.
And would hope to see in depression study and something again, we think is particularly important both in anxiety and opens up the door to potentially having other indications in the future.
Okay, Great and can you remind me where the patients on ssris or whatever they were on or where they wind up.
And this.
In this trial.
Yeah.
Details about the specifics there will be forthcoming.
You know as the full publication is released but generally to comment broadly about your question.
We don't.
As modern data to fully characterize the difference in either.
Pharmacokinetics, and pharmacodynamics are thinking particularly of more interest.
With concomitant administration of <unk>.
A molecule like <unk> and then 120.
Historical data has suggested that there may be an alteration of the PD profile, but we haven't seen any evidence for that would be alarming or safety signals. So something we are certainly monitoring I know others in academic researchers have been interested in and that differentiation of response and certainly as we progress and development that we're going to be looking at very closely.
Okay, Great and then in terms of the R&D day that you mentioned would still be in the second quarter is that where you plan on sharing more details about your commercialization plans for each product or is that kind of at a later time.
I think as we think about in R&D day in second quarter, one of the key things we would like to highlight is an update on the progress of the clinical trial of our overall programmatic approach will speak much more to the intellectual property and market protection strategy and they've got some important insights that should make.
Very clear story to anyone who has been looking at market protection and the ability to protect a novel asset so.
So that would be one area of focus was obviously dig into enhancing key opinion leaders talking about generalized anxiety disorder is an indication where the treatment might fit in the overall landscape and they will also have an opportunity to present.
Some individuals who have actively.
In clinical trials and research.
LSD with drug class generally and provide some insights into the commercial viability in that way I think certainly as we progression and reach.
Phase II readout and are getting to an end of phase II program total clarity on what the path too.
Our late stage program looks like we'll be in a position at that point to speak a little bit more about market access and the overall commercialization strategy, but certainly at our Investor day coming up.
In the second quarter will be giving a lot more insight into the status of the programs.
Greater clarity on some of the elements.
Our ultimate product.
Trying to take the market.
Yes.
Overall approach there.
Okay, great. Thank you very much.
Thanks, Greg.
Thank you. Your next question comes from Alan <unk>, Yes, Hutton Oliver. Please go ahead.
Yes, good afternoon.
What I'd like to very slight Rob is.
20 clinical sites that you previously identified is this the final number for the <unk> trial.
So the 20 clinical sites was suddenly.
Study excuse me the number of sites that as we as we noted earlier in the year.
Were brought online and we are fully recruiting.
Beginning of the year and we've seen a lot of interest from a number of sites in a number of highly experienced sites.
And as we think about site engagement and bringing sites online.
They can both be driven by.
Individual study, but also programmatically right. So we have an opportunity to engage with sites that might be great sites. In a later stage phase III programs. So we're actively engaged with a number of discussions in a number of different avenues to make sure we can be as efficient as possible getting into that pivotal program.
But certainly.
20 sites, where you started and kony actually enrolling patients yes.
Yeah.
At the end of the year would we shall we expect primary endpoint information so efficacy at four weeks or maybe some later time points eight weeks and 12 weeks as you have those as secondary endpoints.
We certainly anticipate reading out.
Top line readout, the four week data, which is the primary endpoint of the study so we're getting greater clarity as we progress and give an update on the study in the future but.
Our expectation when we speak to topline results, we'd be at least reading out the primary endpoint.
Yeah and I'd just.
From this company called mind, bio who is doing a or plan to do a micro dosing.
LSD trial and M D.
Do you think that they would have freedom to operate.
They continue to pursue that indication.
Well again in terms of intellectual property certainly in a research setting there's a carve out for doing research so anything of that nature wouldnt come into play until much later down the road, but and where we're positioned in the program and the kind of support we've had the team we've built the efficiency we will.
We have demonstrated as we get the readout by the end of this year.
Make it very clear.
Everyone stands in the market, who is likely to be.
First to market with any sort of velocity product.
And just last two small questions here.
Do you have a cut off value for the hem a score at baseline in the <unk> trial.
Or.
Minimum severity.
We do I'll turn it over to Dr. Traveling again.
I do.
I don't believe that we publicly disclosed that minimum cutoff score at the current time just to maintain trial integrity. So yes, we do hope we can have the score but.
In general just for integrity purposes.
Yes.
Yes.
I'll just I'll just expand on that real quickly.
If we point you to our Investor presentation published on our website.
The minimum square, we required to be enrolled in the trial as an entry criterion is the Hamilton anxiety score of 20 or greater.
Greater okay. Thanks for clarifying that.
And do you expect a good portion of the patients to have depression as a co morbidity in this study.
Based on the overall population co morbidity of JD in major depressive disorder, we certainly anticipate that the patients would have co morbid diagnosis with depression, what's critically important is.
To have J D as a primary diagnosis.
We would not be a representative population that you had in indications such as JD there wasn't some.
Comorbid depression in the study.
But you are not examining.
Efficacy based on.
Reduction in depressive symptoms.
While we absolutely are.
And secondary outcome measures, we are absolutely looking at.
Response on standard Depression scale, we would use that as another important insight into the potential response in depression.
Wonderful. Thank you very much for both of you.
Thanks Oliver.
Thank you. Your next question comes from Patrick <unk> H C. Wainwright Patrick Please go ahead.
Thanks, Good evening.
I'm wondering as you look at the broader space of sponsors exploring psychoactive agent. How do you view the differentiation of <unk> 120 relative to some of these shorter acting compounds like <unk> five EMEA TMT do you see the advantages primarily on the efficacy and potential duration of remission or is there also potential sept.
Great on safety and Tolerability profile as well.
Yes, I think thanks for the question Patrick.
When we look at the history of research on this drug class.
As a drug developer you want to see drugs that might.
It might be kind of demonstrating a.
Benefit risk.
Right.
Profile, that's ultimately gets you to an application.
<unk> and <unk> is the most characterize dragging the entire class Theres certainly been a lot of discussion about shorter acting molecules.
What we know from the real World I think it's important to highlight that there is.
Fairly large.
<unk> access or compassionate use program.
That's ongoing in Switzerland, and our collaboration with Dr. Leakey, UHD and more broadly with many of the psychiatrist in Switzerland has given us some real insights. These providers are able to utilize psilocybin or LST and in many instances when we have discussions about the preference they choose to use LSD there.
Also as indicated on multiple occasions that the actual conduct of administration sessions, whether its LG or psilocybin occurs for approximately the same duration and thats going to obviously vary by the individual but we thought it was a particularly important insight that in.
In practice in the real World, where this is being done regularly and has been done for several years there isn't a significant differentiation between those two molecules.
The ultra shorter acting molecules such as <unk>. These are certainly.
Molecules that work on serotonin system, but what we need to characterize as.
The both the acute and durable response and Thats, what we suddenly it seemed more from historical data of LST and gives us an extraordinary degree of excitement around the potential of our product candidates.
Can you talk more about the health economic outcome research that you referred to earlier and understanding that there is still more planning here to be done I am wondering what what would this potentially look like prior to the launch.
How big of a differentiator or would it be for EM 120. If you have this type of data at the time of verse soon after a potential launch.
Yes.
I wouldn't want to speak.
Too much the specifics at this point, but we're actively engaged both with.
First of all <unk>, Chief commercial officer, who.
Medical careers.
Commercial launches, including most recently at Merck before coming over to mind med to demonstrate the value proposition and make sure. We have a path for commercialization for market access to reimbursement and also our digital medicine programs, which gives us an extraordinary opportunity to gather such data and engage in and long.
<unk> observation studies, both those patients with the disorders, we are seeking to treat but also more specifically in some.
Some particular areas of research interest to us both internally and through some of our collaborations. So it certainly would be sharing more as we progression and as we get to have more clarity in our share more clarity I should say on the commercialization pathway and our alternate plans.
Give additional insight in terms of our approach to HR data generation and also the implications for market access pricing reimbursement as such.
Yeah. That's helpful. Just one last one for me can you talk about just broader strategic priorities as it relates to business development.
Specifically, how do you think about potential partnership activity following the phase III Readouts from mm 120 later this year.
Yes, we've certainly seen quite a bit of interest in <unk>.
Our program and our readout and.
And any time, where we were advanced to the point.
Could you disclose your special we will certainly do so.
But at this point, we haven't we do not have any.
Got it.
This development or licensing or partnership agreements.
Subsequent development program, but again, we've seen high.
A high degree of engagement and excitement both in terms of.
Serotonin system as a target, which is one of the best characterize it.
Systems in all psychiatry, but also in particular in our programming and our approach the ability to generate the kind of robust data and the consistency with which we're approaching our clinical development program. Our phase III study design and the way we've operationalized. The study is exactly how we anticipate progressing into the phase III program, and we think that gives us.
A great opportunity to.
Transitioning out without without changing any of the variables that are important in terms of contract with Saudi and endlessly could impact safety or effectiveness.
So there's a lot of excitement across the board.
And we will keep any of our options open as it progressed.
That's helpful. Thank you very much.
Thank you, ladies and gentlemen, as a reminder, should you have a question. Please press star one on your Touchtone phone.
There are no further questions at this time I will now turn it back for closing remarks.
Thank you operator, and thanks, everyone again for joining us today.
We're extremely pleased with where we've come so far this year and are incredibly encouraged by <unk>.
Moving very quickly to a data readout in late 2023 for our lead program and getting our second lien program and then 402 into the clinic later this year.
Thanks, everyone again for joining us and we look forward to sharing future updates.
Thank you ladies and gentlemen. This concludes your conference call for today, we thank you for participating in that that you. Please disconnect your lines.