Q1 2022 Mind Medicine (MindMed) Inc Earnings Call

[music].

Good morning and welcome to the My Medicine First Quarter 2022 Financial Results Inc. Update Conference Call.

Good morning, and welcome to the mind, Mitch Medicine first quarter 2022 financial results and corporate update conference call.

Commonly, all participants are in illicit only mode. This call is being webcast live on investor and media section of MindMeds website at mindmed.co and recording will be available after the call.

Currently all participants are in a listen only mode. This call is being webcast live on investors and media section of my Meds website at mine met that co and recording will be available after the call.

For open remarks, I would like to introduce Robert R. CEO of MyMed. Please go ahead, sir.

For opening remarks, I would like to introduce Rob barrel CEO of my met please go ahead Sir.

Thank you and good morning.

I appreciate everyone joining us for our first quarter 2022 financial results in corporate update conference calls.

I appreciate everyone joining us for our first quarter 2022 financial results and corporate update conference call.

The press release reporting our financial result is available in the Investors and Media section of my Meds website and our quarterly report on Form 10Q for the quarter ended March 31st, 2022. We'll be filed today with the Securities and Exchange Commission. Joining me today is Dr. Daniel Carlin, our Chief Medical Officer and Dr. Miri Halper and Warnley.

The press release reporting our financial results is available in the investors and media section of my website and our quarterly report on Form 10-Q for the quarter ended March 31, 2022, it will be filed today with the Securities and Exchange Commission. Joining me today are Dr. Daniel Carlin, our Chief Medical Officer and.

Dr. Mary Halpern worthy our executive President.

During today's call, we will be making certain for the statement, including without limitation, statements about the potential, safety, efficacy, and regulatory and clinical progress of our product.

During today's call, we will 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 expectations, plans, partnerships and prospects. These statements are subject to various risks.

<unk> financial projections, and our future expectations plans partnerships and prospects. These statements are subject to various risks.

that are described in the filings made with the SEC, including the most recent annual report on Form 10K.

And are described in our filings made with the SEC, including the most recent annual report on Form 10-K.

Your caution's not to place undue reliance on these forward-looking statements, which are made as of today, May 16, 2022.

You are cautioned not to place undue reliance on these forward looking statements, which are made as of today may 16 2022.

By meddisclings any obligation to update such statement, even if management's views change.

<unk> disclaims any obligation to update such statements, even if management's views change.

Before we dive into our program and corporate update, I would like to re-emphasize our ambition to transform the treatment of brain health disorders by delivering on the therapeutic potential of psychedelics and other novel targets.

Before we dive into our program and corporate update I would like to reemphasize, our ambition to transform the treatment of brain health disorders by delivering on the therapeutic potential of psychedelic and other novel target.

We're applying our pharmaceutical expertise to develop these innovative therapies with the aim of generating rapid and sustained improvement and patient outcomes, with applicability to anxiety, addiction, and even autism.

We are applying our pharmaceutical expertise to develop innovative therapies with the aim of generating rapid and sustained improvement in patient outcome.

Replicability to anxiety addiction, and even autism.

This is more important now than ever.

Good news is there has been a significant expansion in research to treat these conditions and my med is leading the way in this step.

The good news is theres been a significant expansion in research to treat these conditions in mind that is leading the way in this effort.

At my Metabere you don't have any decades of research to accelerate and de-risk our three lead drug candidates, NM120, NM110, and NM402, along with other novel fairs.

And mine that appear utilizing decades of research to accelerate and de risk. Our three lead drug candidates and then one 'twenty and then 110 and then four O two along with other novel therapies.

We are extremely pleased with the progress of transformational growth that continues to propel our business forward. A position mind met is a leader in developing novel therapies to treat brain health disorders.

We're extremely pleased with the progress of transformational growth continues to propel our business forward.

Mission mine bad as a leader in developing novel therapies to treat brain health disorders.

I will now turn the call over to our chief medical officer, Dr. Daniel Carlin, to provide additional updates on each of our development programs. Dan?

I will now turn the call over to our Chief Medical Officer, Dr. Daniel Carlin provide additional updates on each of our development programs.

Thank you Rob.

Thank you, Rob. Our drug pipeline at my med include the exciting drug candidates that are either currently in or are nearing clinical trials. On this call, I will focus on the program with the most near term visibility and highlight upcoming milestones starting with our lead drug candidate and number 120.

Jumped paypoint at my maybe includes exciting drug candidates that are either currently in or are nearing clinical trials on this call I will focus on the programs just the most near term visibility and highlight upcoming milestones starting with our lead drug candidate and then what 'twenty.

MM120 is a proprietary pharmaceutical optimized form of LSD that builds on extensive evidence of clinical benefit and the mechanistic top rationality and psychiatry, pain and substance use disorders. The tolerability, pharmacokinetics, and pharmacodynamics of LSD are well characterized with over 1,000 patients treated in clinical trials to date. Further, LSD has demonstrated the potential to provide rapid and sustained benefit after acute dosage.

And then 120th of proprietary pharmaceutical we optimized form Ive got let's see it builds an extensive evidence of clinical benefit and mechanistic rationale in psychiatry pain and substance use disorders.

Her ability pharmacokinetics and pharmacodynamics of electricity are well characterized with over 1000 patients treated in clinical trials to date further unless he has demonstrated the potential to provide rapid and sustained benefit after acute dosing.

We are developing MM120 for the treatment of generalized things ID disorder or GAD, attention deaths at hyperactivity disorder or ADHD in product pain. Beginning.

We are developing and then 120 for the treatment of generalized anxiety disorder or G. D. I can see.

The deficit hyperactivity disorder, or ADHD and chronic pain.

With our most advanced program J D is a debilitating mental health disorder that affects approximately 6% of U S. Adults in their lifetime symptoms of JD and crude access of anxiety and worry that persist over six months that can lead to significant impairments in social occupational functioning there has been very little innovation.

GAD is a debilitating mental health disorder that affects approximately 6% of US adults in their lifetime. Symptoms of GAD include excessive anxiety and worry that persists for over six months that can lead to significant impairments in social, occupational, and other functioning. There has been very little innovation focused on the treatment of GAD over the past several decades.

Focused on the treatment of G E D over the past several decades last.

Last week on May 11th, Dr. Friedrich Holts and Professor, Dr. Matthias Lichten, my medical apparatus at the University Hospital Basel, UHB, presented results from the LSD Assist study. It fades to placebo-controlled investigator and initiated trial of LSD in the treatment of anxiety disorders as buttons psych symposium.

Last week on May 11th Dr. Friedrich holds and professor Dr. T. As Micky might've been collaborators at the University Hospital of Basel U H B presented results from the Atlas V. S. Chest study a phase II placebo controlled investigator initiated trial, let's see in the treatment of anxiety disorders.

Take symposium preliminary top line safety and efficacy results for at least the 46 patients with clinically significant anxiety demonstrated the significant rapid durable and beneficial effects of LFC and potential to safely mitigate symptoms of anxiety and depression.

Preliminary top-wide and safety and ethics use results for LSD in 46 patients with clinically significant anxiety, demonstrated the significant rapid, durable, and beneficial effects of LSD, and potential to safely mitigate symptoms of anxiety and depression.

LSD and dose of 200 micrograms resulted in significant and strong reductions of global state, trade, anxiety, inventory or STI-G stores 16 weeks after treatment in the between subject analysis with a statistically significant improvement from baseline compared to placebo.

Oh, let's get a dose of 200 micrograms resulted in significant strong reduction of global state treat anxiety inventory, where sky G scores 16 weeks after treatment in the between subject analysis with a statistically significant improvement from baseline compared to placebo.

LSD was well tolerated. Only one serious adverse event was considered related to treatment and consisted of acute transgae anxiety and delusions during an LSD session.

<unk> was well tolerated only one serious adverse event was considered related to treatment and consisted of a cute transient anxiety and delusions during an analyst day session. There were no recorded instances of treatment emergent suicide ideation with intent suicidal behavior or intentional self injury. The trial was conducted at two centers.

There were no recorded instances of treatment-emergent suicidal ideation with intent, suicidal behavior, or intentional self-injury. The trial is conducted at two centers, UHV Lifty Lab and the psychiatry practice of Dr. Peter Gasser.

Uhm Mickey lab in the psychiatry practice and Dr. Peter Gassner, we believe the results from.

We believe the results from the LSDSS study further support our critical development of MN120 in GAD.

This study further support our critical development and 120 N G E D.

As a reminder, in January of this year, the FDA cleared our investigational new drug application for I&D for our randomized Phase 2B dose optimization trial of MN120 for the treatment of GAD.

As a reminder in January of this year, the FDA cleared our investigational new drug application or I D for a randomized phase two b dose optimization trial, and then 120 for the treatment of G E D.

The trial plans to enroll a total of 200 participants who will receive a single administration of up to 200 micrograms of MM120 or a placebo. The primary objective of this study is to determine the reduction in anxiety symptoms for up to 12 weeks after a single administration of MM120 across five treatment arms. These events mark the start of the first large commercially sponsored study of LSB in more than 40 years.

Tayo planes to enroll a total of 200 participants will receive a single administration of up to 200 micrograms of and then 120 or placebo.

The primary objective of this study is to determine the reduction in anxiety symptoms for up to 12 weeks. After a single administration and then one 'twenty across five treatment arms.

These events marked the start of the first large commercially sponsored study of LFC and more than 40 years.

The results of this trial will guide the dose selection and development strategy for our pivotal phase three clinical trials, as well as deepen our scientific understanding of the clinical effects of MM120 and its underlying mechanisms of action.

The results of this trial will guide the dose selection and development strategy for our pivotal phase III clinical trials as well as deepen our scientific understanding of the clinical effects of EM 120, and its underlying mechanisms of actions.

With the study underway, we look forward to building on this momentum and progressing through the trial as quickly and efficiently as possible to address the unmet needs of patients who suffer from GAD.

The study underway, we look forward to building on this momentum progressing through the trial as quickly and efficiently as possible to address the unmet needs of patients who suffer from J D.

In parallel, we continue to enroll patients for our Phase 2a Proof-of-Concept trial to MM120 for the treatment of ADHD.

In parallel we continue to enroll patients for our phase Iia proof of concept trial with Min 120, <unk> for the treatment of ADHD.

In addition to our ongoing Phase 2 studies for MM120 in GAD and ADHD, we are currently advancing our strategic plans for MM120 in the treatment of chronic pain. We plan to initiate a Phase 2a trial of MM120 in chronic pain in the fourth quarter of 2022. Moving on to our working subset.

In addition to our ongoing phase two studies for mm 120, and G. A D. H D. We are currently advancing our strategic plan and then 120 in the treatment of chronic pain, we plan to initiate a phase Iia trial, and then 120th chronic pain in the fourth quarter of 2022 movie.

Moving on to our work and substance use disorders, there's a major unmet need to address the ongoing and ever growing opioid crisis and provide effective treatment solutions for withdrawal management, our proprietary molecule and then one thing also known as the mini cans or 18 M C.

There is a major unmet need to address the ongoing and ever-growing opioid crisis and provide effective treatment solutions for withdrawal management.

Our proprietary molecule, MM110, also known as Linacant or ATNMC, is an alpha-3, beta-4 nicotinic cholinergic receptor antagonist that has been tested extensively in preclinical models of withdrawal and substance use disorders. MM110 has been shown to reduce signs of opioid withdrawal and reduce self-administration of opioids, stimulants, nicotine, and ethanol in preclinical models.

Three beta poor nicotinic cholinergic receptor antagonist that has been tested extensively in preclinical models of withdrawal and substance use disorders, and then one tenant has been shown to reduce signs of opioid withdrawal and reduce self administration of opioids stimulants nicotine and ethanol in preclinical models.

Extensive pharmacology and toxicology studies have also shown MM110 to have a safety and tolerability profile that supports our clinical development program.

Extensive pharmacology and toxicology studies have also shown and then one safety and Tolerability profile that supports our clinical development program.

We recently completed a phase one trial of MM110 in late 2021, which assessed the safety, tolerability, pharmacokinetics, and cognitive effects of MM110 in healthy volunteers. In this phase one single ascending dose and multiple ascending dose trial, subjects either received doses between 8 milligrams and 650 milligrams on one day, or daily doses between 4 milligrams and 180 milligrams per day for up to seven days.

We recently completed a phase one trial it and then 110 in late 2021, which assessed the safety Tolerability pharmacokinetics and cognitive effects and then one testing in healthy volunteers in the phase one single ascending dose and multiple ascending dose trial subjects either received doses between eight milligrams and 650 milligram.

On one day or daily doses between four milligrams and 180 milligrams per day for up to seven days 77 participants received and 110 and 31 participants received placebo.

77 participants received MM110 and 31 participants received placebo.

The results of this successful Phase 1 study, in conjunction with the preclinical characterization of MM110, have informed the Phase 2a trial design that we plan to initiate in the second quarter of 2022.

The results of this successful phase one study in conjunction with the preclinical characterization, but <unk> has informed the phase Iia trial design that we plan to initiate in the second quarter of 2022.

Earlier this month, we announced an upcoming Key Opinion Leader webinar on Addiction and Withdrawal Management featuring presentations from Dr. Kelly Dunn, a professor at Johns Hopkins School of Medicine, and Dr. Stuart Gitlow, past president of the American Society of Addiction Medicine. This webinar will be held on Thursday, May 19th at 11 a.m. Eastern Time, and registration can be accessed through the Investors and Media section of MindMed's website.

Earlier this month, we announced the upcoming key opinion leader webinar on addiction, and withdrawal management featuring presentations from Dr. Kelly done a professor at Johns Hopkins School of Medicine, and Dr. Stuart get though past president of the American Society of addiction Medicine.

Webinar will be held on Thursday may 19 at 11, a M. Eastern time and registration can be accessed through the investors and media section of my website.

We look forward to this discussion about the current treatment landscape and unmet medical needs that exist in treating substance use disorders and managing opioid withdrawal. Following Drs. Dunn and Gitlo's presentations, we will provide an overview of MM110 and its potential to address a key gap in the available treatments for opioid use disorder.

Look forward to the discussion about the current treatment landscape and unmet medical needs that exist in treating substance use disorders and managing opioid withdrawal following doctor's done and get those presentations, we will provide an overview of and 110 and its potential to address a gap in the available treatment for opioid use disorder.

I'll now turn to our third lead program and then pour out U R. M DNA, which is a synthetic and anti-american DNA exhibit pro social activity in preclinical models.

We are developing MM402 for the treatment of the core symptoms of autism spectrum disorder, or ASD, which is a developmental disorder characterized by atypical social communication and interactions, repetitive patterns of behavior, and restricted interest.

We are developing and then port O two for the treatment of the core symptoms of autism spectrum disorder, or a S. D, which is a developmental disorder characterized by atypical social communication and interactions repetitive patterns of behavior and restricted interest preclinical studies of our M. D. M. A demonstrated its acute pro social effects.

Preclinical studies of rMDMA demonstrate its acute prosocial effects, while its reduced dopaminergic activity suggests that it will exhibit a favorable safety and tolerability profile compared to racemic MDMA or the S enantiomer. Additionally, rMDMA has been shown to maintain prosocial effects with reduced stimulant activity compared to MDMA, and we believe may have the potential to be administered in a standard dosing regimen.

Reduced dopaminergic activity suggests that it will exhibit a favorable safety and tolerability profile compared to racemic M DMA or the S. Enantiomer. Additionally, our MD&A has been shown to maintain pro social effects, which reduce stimulus it could be compared to M. DNA and we believe they have the potential to be administered in a standard dosing.

Okay.

We are currently connecting IND enabling studies to facilitate sponsored phase one trials of RMDMA beginning in 2023.

We are currently conducting I N D. Enabling studies to facilitate sponsored phase one trials are M. D may be getting in 2023.

Additionally, through our research collaboration with University Hospital Basel, we plan to initiate a comparative Phase I pharmacokinetics and pharmacodynamics trial of R, S, and racemic MDMA in healthy volunteers in the third quarter of 2022.

Additionally, through our research collaboration with the University House go Basel, we plan to initiate a comparative phase one pharmacokinetic and pharmacodynamics trial of R. S N racemic MDMA and healthy volunteers in the third quarter 2022.

Our drug development strategy is closely complemented by a platform of digital medicine products that have the potential to facilitate adoption, use, and most importantly, broad and diverse access to our therapeutic products.

Drug development strategy as closely complimented by a platform of digital medicine products that have the potential to facilitate adoption use and most importantly, broad and diverse access to our therapeutic products in January of this year, we initiated the session monitoring system SMS wanted to study, which leverages. The mine mid session monitoring system or M. S. M S.

In January of this year, we initiated the Session Monitoring System, SMS-01 study, which leverages the MindMed Session Monitoring System, or MSMS, to evaluate the passive collection of sensory data during a consciousness-altering therapeutic session. MSMS is a technological platform that provides the foundation for the development and implementation of a suite of products for use by clinicians and patients during treatment sessions that may also include the use of consciousness-altering medications.

To evaluate the passive collection sensory data during our consciousness altering therapeutic session M. S. N messenger technological platform that provides the foundation for the development and implementation of a suite of products that are used by clinicians and patients. During treatment sessions that may also include the use of consciousness altering medications the launch of <unk>.

The launch of this study is an important milestone for our future development of regulated devices and software as a medical device.

This study is an important milestone for future development of regulated devices and software as a medical device.

or SAMD products that are designed to support novel analyses of multimodal data in the delivery of psychiatric care. The study will provide data that support the development of critical analysis algorithms.

M D products that are designed to support novel analyses of multimodal data in the delivery of psychiatric care. This study will provide data to support the development of critical analysis algorithms. Subsequent studies, we intend to provide the evidence necessary for FDA clearance.

Subsequent studies will intend to provide the evidence necessary for FDA clearance.

The second of our key active picture medicine efforts, which we call anxiety digital diagnoses for precision Sky tree or adapt is a combination of a natural history study, which is to say that it follows a group of people over time.

Or at risk for developing an anxiety disorder and a newly developed mobile application that we built specifically to support the study. This study and its supporting App have lunched in private beta and are currently enrolling by invitation or a third key digital medicine effort, the quantifying the processes and events in psychotherapy at scale.

<unk> study.

Can use to enroll subjects in participating psychiatric clinics. This study is providing a remarkably rich and robust dataset to enable a better understanding of patient progression trends and characteristics in the real world treatment environment and informed all aspects of our program planning.

We believe our digital medicine products and projects could have monitoring and therapeutic benefit across a range of psychiatric disorders by refining their techniques used to capture model and map, the autonomic and behavior of outflow and other correlates of neural activity. We aim to improve the experience of clinicians and the outcomes for patients and the delivery of psyche.

And other perception altering substances and psychotherapy. Our team has worked incredibly hard to advance these products into the clinic and we remain dedicated to rolling out these novel approaches and improving psychiatric outcomes for patients. Overall, we are extremely excited about these advancements and the value driving milestones ahead with that I will turn the call over to Dr.

Merely helping windy or executive president to discuss our exciting research collaborations and early stage research and development activities here.

Thank you Dan.

We then aim towards accelerating our R&D efforts, we collaborate with leading research organizations around the world.

It provides valuable opportunity to advance novel treatment for brain health.

Yeah.

Nine net collaborate with a niche be lab at University hospital bothered in Switzerland.

And has exclusive global rights data compounds and patents.

It was their research program evaluating.

D N DMA mescaline and DMT.

This includes data from numerous completed and ongoing phase one and phase two study.

These ongoing collaboration has generated a number of patent application and has been invaluable in derisking and informing our drug development program.

In addition to all of you like to be collaboration we have an ongoing partnership with my Chief compounds Mimi said in Baghdad, Switzerland on the drug discovery and optimization platform developing and characterizing next generation research compound we all relate.

I see.

And pharmaceutical technology owned outright by mine.

Lastly, our ongoing research collaborations, but usually in your drug development organization next stage therapeutics.

To explore the therapeutic utility of our proprietary brain targeted liposome deliberate technology to mitigate risks.

Adverse effects with certain molecules.

No are you building.

I will now turn it back over to Rob.

Thank you Mary.

We will now turn to our financial results for the first quarter ended March 31 2022.

As of March 31, 2020 to find that had cash cash equivalents and short term investments totaling $125 million compared to $133 $5 million as of December 31, 2021.

My net believes its available cash equivalents will be sufficient to meet its operating requirements into 2024.

The net cash used in operating activities was $12 $9 million for the three months ended March 31, 2022 compared to $10 million for the same period in 2021.

Research and development expenses were $10 $2 million for the three months ended March 31, 2022, compared to $6 $8 million for the same period in 2021 the.

The increase of $3 $4 million was primarily due to $4 $4 million of internal expenses related to compensation costs for additional head count, which totaled $2 million and an increase in noncash expenses of $1 $7 million of stock based compensation expense.

This increase was offset by a decrease in external spending if point $8 million related to our preclinical and other programs.

General and administrative expenses were $8 $3 million for three months ended March 31, 2022 compared to $7 million for the same period in 2021.

The increase of $1.3 million was primarily due to an increase of $9 million noncash stock based compensation expenses.

Other contributors to the increase included professional services, such as accounting audit legal compliance director and officer insurance, and Investor and public relations and personnel costs to support the growth of the company.

The net and comprehensive loss for the three months ended March 31st 2022 was $18 $5 million compared to $13 $8 million for the same period in 2021.

Overall, the first quarter of 2022 was marked by steady progress across our drug and digital medicine pipeline.

We continue to build a world class pharmaceutical company and attract top talent at all levels of our organization.

We recently announced the appointment of Dr. Francois Laurin thought as our Chief commercial officer, who brings more than two decades of global biopharmaceutical experience from Merck Johnson and other organizations to support advancement of our clinical and commercial objectives.

I'm incredibly proud of the growth in numerous achievements across all areas of our organization.

And not be more grateful for the incredible people, both within and outside our organization, who make this critical work possible.

With that I'd like to thank you all for being here today and I'm happy to take any questions.

Thank you we will now conduct a question and answer session.

I'd like to ask a question. Please press star one on your telephone keypad.

A confirmation tone will indicate your line is any question queue.

You May press Star two if you would like to remove your question from the queue.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Once again Thats star one to ask a question at this time, one moment, while we poll for our first question.

Our first question comes from Patrick <unk> with H C. Wainwright. Please proceed.

Good morning, and congrats on all the progress I have a couple of follow up questions on the 'twenty program first just I'm wondering what was seen with the safety and Tolerability in the U S. B trial was different in any way from historical studies conducted with L. S. D. Secondly, can you discuss them.

Other detail what read through from the UHD program and I'll, let Steve it could be expected to the phase two b trial for M. M 120, and ER G. A D and an anxiety disorder.

And were there any key differences or what are the key differences in the study as you know including on the point that we should keep in mind as we look to that read through.

Yeah.

Absolutely. So thanks, so much Patrick.

The U S B study that you're mentioning.

As we said during the call was presented last week at symposium in London, and really the most modern.

Quality study ever conducted.

It's really directly impactful on our program.

And does read through does translate directly into the phase two study, we have ongoing and anticipate dosing our first patient.

In coming months.

In terms of the adverse effects and adverse events, we saw in the U S. B study there really was nothing inconsistent with the drug class or with LSE.

When you look at the literature for.

For both LST in for Al if I could Alex now commonly.

Commonly see nausea, anxiety and snakes as with most drugs being higher up in the west and that's really what we saw in terms of thinking related to that the only.

Only.

But I think it does.

It can be important to the only.

This adverse event that was observed was and acute transient anxiety.

And one patient there was no suicidal.

Suicide related.

If they use or a observed.

During the study so.

We obviously are very excited in light of those findings and whether that's due to the.

Indicating that the patient population <unk>.

The specific activity of LST or its potency.

All of those could be quite positive as you progressed.

Our phase two program.

In terms of the key differences in and really to read through and how it informs.

One of the thing I think is most relevant is the fact that this study tested 200 microgram dose or LST and we know that in comparison to what's been studied historically psilocybin that dose is even higher than what most of the philosophical studies and one of the interesting findings that we saw from the survey it really high correlation.

And statistically significant correlation between the acute positive effects.

And the clinical outcomes and reductions in Hamilton anxiety score that's not something that has really been reported extensively a previous study and one that is critically important because it provides some level of a proxy that we can use to target acute activity that we can anticipate correlate.

Would that longer clinical response or <unk>.

Very excited to see those data and we'll use that to inform certainly how we think about.

Acute activity and targets and are more treatment sessions, both in the phase two study and beyond is to continue to build the dataset.

That said I think it's critically important to realize that the dose response study that we're conducting in phase two b will go a very long way twin brother that understanding but also to give us the best opportunity.

To see this desired effect in the most patient possible because of the incredible activity and giving an incredible potency of L. S. D. It really gives us a unique opportunity.

To push push the upper bounds in and make sure that we are dosing appropriately both for the magnitude of the acute effect inferred to enhance the likelihood of a durable effect.

So all of the data that the Pharmacodynamic data that we observed a correlation to clinical activity, but also the.

Most importantly, the strong positive signs that you see from the study that was statistically significant.

I'll read through and correlate with what we're doing our phase two program.

Yeah, one other difference I would highlight is that we are using the Hamilton anxiety scale the primary importance.

There is a good body of.

Please me.

Good body of evidence from the literature that Daiichi and Ham and.

Our measuring the same thing in her and her correlated in terms of clinical response.

But certainly the Hamilton anxiety scale is what we'll be using for regulatory approval for Jonathan tiny disorder, that's been progressing the phase two and.

Basic program.

Yeah, Yeah. That's really helpful that was kind of you know part of my My next question. So just specifically on the phase two b trial at baseline patients are required to have a hem a greater than or equal to 20. So I'm wondering if you could you know I guess first tell us what what other comorbidities or any one payer.

<unk> do you expect it to hover what exclusions would there be for things such as depression or other comorbidities or some proportion of patients expected to have some of those comorbidities secondly, what.

These patients are expected to have any experience with psychoactive agents.

And then how was the placebo or how is it being determined for the trial you know what input from regulators was given and then just finally you know what is the study power to generate in terms of improvement in the Hebei.

Yeah.

Yeah, Oh, great great questions I'll try to make sure I get all of those Patrick.

So in terms of the comorbidity that based on we certainly anticipate that there will be a.

The diagnosis of major depressive disorder that will also come into the study of course J D needs to be the primary diagnosis, but.

Yeah.

Incidents of J D N and M. D D. Comorbidities is incredibly high and so we certainly anticipate.

There will be overlap and importantly that was the case in the UHD study as well, where we also saw a statistically significant responses.

In the Ham D and the BVI. So we saw reductions in but anxiety and depression and that's H B study, which we think will translate into our phase two program, hopefully and even beyond that as we look at.

Other comorbid psychiatric indications the other other psychiatric indications that would be excluded are those where there is a.

Our perceived risks with this drug class, which is bipolar disorder.

There are certain indications that are going to be.

Generally and categorically exclude it.

From.

All studies things like that like drug class because there are some historical concerns about.

Using this drug classes in those patient populations, but generally as we look at this indication J D is incredibly prevalent.

Disease disorder in our country and and one where we are trying to get a representative sample of this population where there is a considerable amount of comorbid psychiatric diseases.

You mean, the other part of your question I think make sure.

Miss anything please reach out.

Extend but you asked about the.

Use of a placebo and input from regulators.

In our phase <unk> study, we designed it as a five arm.

Treatment.

There are four active arms of LST.

And her placebo comparator.

As you know there's been extensive discussion around the use of an appropriate control appropriate placebo condition in these studies and by using these these five treatment arms. It actually gives us we believe the best opportunity to.

To both learn from and observe.

The placebo response in placebo controlled responses and blinding.

Because we have both a true placebo from here again, and we have a 25 microgram dose of Neulasta heated right at that dose of perceptual effects.

Just at the sort of threshold level for LST and so it does give us a really unique opportunity to see both the dose response curve and to confirm that there is a non zero dose response curve.

But it also allows us to do post hoc analyses for pair wise comparison against the true placebo again.

Extreme.

Extremely low dose.

Arm and we think all of that would be incredibly informative as we progress further into.

The development program one of the things a lot of the discussions historically with regulators around appropriate placebo controls are not informed by current high quality studies that would allow us to compare the different controls and so by generating some level of that evidence it gives us valuable data.

It is directly relevant to our subsequent regulatory discussions before moving to pivotal studies.

Yes, the last part of that.

Yes.

Go ahead please.

I was just going to say that the proportion of that would be expected to have experience with the psychoactive agents what would that be.

Yeah, we really anticipate it being on the lower end of the.

Low teens, perhaps 10% that is not a strict target that is.

Just like our historical learning from other studies and.

Looking at historical.

Circle clinical trials in this space. So we don't have a hard.

Lou about the percentage or a hard target for the percentage of prior like prior psychedelic east we do exclude.

Patients, who actually use pattern or something that would.

Essentially confound study results or be problematic in terms of their history of using psychedelics.

Right and then just the last part of it was just around the powering for the study of Manhattan, and what what kind of level of improvement from baseline relative to placebo.

Or are you targeting in the trial.

Yeah. So one of the one of the key things.

To note here is that the statistical analysis for the Phase two study is anticipated to be.

Targeted aren't demonstrating a dose responsive effect. So it is a methodology that you used to in a very commonly in dose optimization study to both.

Pick a or demonstrate a non zero response curve and confirm what that dose response curve is prior to selecting an optimal dose to bring forward into phase III studies. So.

We are powered to detect a dip.

For instance, it would be in line.

Any minimum inline with historical.

Standards of care in treating an improvement on those standards.

Bob.

That is looking at it if you look at historical literature for analytics.

Effect sizes.

Somewhere in the 3.4 Cohen's D range than we were anticipating.

We're targeting two to pick up clinical response that would be slightly greater than that so there's something around that one five range.

Got it and if I could just one more on the on the program at baseline when patients had been expected to have failed any prior treatments, including standard of care treatments.

We do not have that as a required entry criteria into the study because this is a phase II B study.

We feel it's important as with all drug development programs to take a rigorous approach to define the population, but also gather data that can inform subsequent development.

In so doing we are suddenly.

Very focused on patient's medical and psychiatric history of medical or excuse me, a medication history, which will inform.

How we progressed further into development.

We were very interested of course and are looking.

Looking at subgroup analyses.

After we complete the study and I was talking analysis from our phase two study, which will inform where we go in terms of patient selection and potential indication refinement as we progress further into development, we do not have any specific requirements going into this study.

That's very helpful. If I could just I will just one on the M. M 110 program I'm just wondering what learnings you know emerge from the M D.

D O three phase trial that informed the design of the phase Iia trial.

Okay.

Yeah.

The goal of phase one is to define it.

The safety and Tolerability.

Pharmacokinetics.

The molecule and.

So looking at the data from those studies.

Very important in terms of giving us clarity about the dose regimen.

Exactly how we want to progress the street, but it's also important in light and again.

Denver during the call.

In light of the.

Very robust datasets, we have from preclinical models, where we observed just a single dose of N. M. One time can have a prolonged.

And these preclinical models for self administration.

We also believe that in this population a model where less frequent treatment can be given as opposed to multiple multiple doses a day and over.

For every everyday for many days will be preferable because there is.

Ah patient compliance concern and if we can demonstrate.

Less frequent dosing has.

A strong kind of corresponds I'll be very meaningful.

The treatment landscape for opioid withdrawal.

Beyond that we will be having our R. K O all of them. This Thursday.

And I know you're excited to share more about that particular landscaping and more about the programming.

We'd really point to that event and it's where we share even further clarity on the learnings from our phase one study.

That's great. Thank you so much.

Thanks, Patrick.

Our next question comes from Michael.

Ah come which with Maxim. Please proceed.

Hey, guys. Thank you so much for taking the question.

So I'd like to follow up on one of Patrick's questions regarding the U H b dataset in generalized anxiety.

Specifically.

Are there any.

Key differences between the U H B study in your ongoing phase II B in terms of you know.

The treatment protocol, the role of psychotherapy or how you're actually.

A recording the outcome measures such as the change in the anxiety scale.

Yeah.

[noise], yes, it takes so much Michael.

So there there are certainly some differences and as you'd expect translating into a commercial development program.

We have.

Our study design and methodologies that.

Our standard for any anxiety program.

In terms of the treatment regimen and in fact their therapy.

One of the most important things to highlight here is that.

U H b collaboration or partnership with both Dr Leakey and his collaborators.

Dr. Peter Gastro have informed exactly what we're doing in terms of.

Psychosocial support.

Safety and supported surround that goes along with treatment session with LST.

So what we are doing in the clinic is very much informed by those historical practices. It's also worth noting that those practices are not limited to this.

L. S. D assist study that was just presented but in Switzerland.

Long.

History and currently there's something along the magnitude of 30 psychotherapist, who are able to provide <unk> therapy.

Two patients and we use learnings from all of that used to inform exactly what we're doing in our development program for our policy.

And then in 'twenty.

With that said I think it's important to note.

Is that how we frame how we approach.

Dot therapeutics around for the delivery of interim on 20th session is going to be very important in terms of scalability.

In terms of feasibility for labeling and ultimately how we get this out into the world. If we're successful in getting that 120 approved and so we are definitely up.

Package, the psychotherapy or excuse me not like a theory that the therapeutic surrounding its like a social support.

And so much informed by those historical use cases in clinical trials, but we've presented it both in terms of our approach in the clinical trial and with regulators and a framework that is.

Standard and more readily acceptable and a doctor who we believe are.

For treatment of psychiatric patients. So all that said it does not dramatically different we still have patients who were brought in to be educated who are overseeing and monitored by dosing session monitors during the treatment session and then had a follow up visit.

This is not a in many months of therapy program that we administer and our development program, but.

Package and a like a social surround that we believe is both.

Adequate end and based on the historical evidence base it will be so important.

To bring forward into the clinic and actually into the world to patients.

In terms of how often measures are collected.

There's also certainly if it was a methodological differences.

Nothing that I think as you look at the Multicenter study against.

Approximately 20 studies, we're targeting for our phase II study in 200 patients.

That scale.

Requires.

Additional.

It's important and infrastructure and so we do use.

Oh.

Centralize more centralized assessment of the kind of acre measures to try to enhance that separation from those who are.

Delivering care in and who is who are awaiting the outcome measures.

We also have extensive controls to monitor across all of our clinical endpoints to ensure the validity and.

Just to see those data cross site.

Alright. Thank you very much I appreciate the additional color I'd also like to.

Touch on your does it digital medicine initiatives, if I understand correctly. It seems like for some of them. They will be used in conjunction in the ongoing clinical studies. So.

How does the F D a view pursuing a Sam D.

Medical product in the clinical trial concurrently with a drug product are there any additional challenges or complications and Sam be somewhat implies a benefit to outcomes through the use of the software.

Yeah. So the.

Important question and I want to make sure that we have clarity on this is that we do have parallel development pipelines for our drug therapies and our digital.

So they stay on the D product that we are developing.

Not at the moment are included in our clinical trials of <unk> 120.

We look to develop them independently and then.

As we progress Theres always the opportunity to bring them back together, whether it is through.

Companion or or or.

Companion use or a combination products.

The further future.

At this time, we do not have them an integrated development programs, whereby we're developing a sam deep product in our phase <unk> clinical research for them at 120.

Alright, Thank you very much and then.

I guess, one more just strategically given where you are in terms of your strong balance sheet and where the markets have traded.

Is M&A, representing an objective for my estimate at this time.

We're always interested in finding opportunities that will.

It would be accretive to value for our shareholders and that will represent a nice addition to our pipeline certainly.

As we've seen the market landscape and other opportunities.

Sure.

Always keeping our eyes very much open and inconstant.

Dialog in exploration to <unk>.

You can identify opportunities for that long term expansion for near term growth and for ultimately to build the most robust in the strongest pipeline in this entire drug classroom tired sector.

So we can drive that long term value in.

Deliver on our mission to be the leaders in developing brain health disorder treatment.

Okay.

Right. Thank you very much I appreciate you taking my questions.

Thanks, Michael.

Our next question comes from Elmer Payrolls with Roth Capital. Please proceed.

Yes, good morning, Rob.

Just wanted to make sure that I heard it correctly that you would be presenting at this scale event. This Thursday, you wouldn't be presenting phase one data.

D V. The 18 M C.

So yeah, we anticipate providing some additional clarity in terms of our development program overall in terms of our.

Recent findings and how that translates into our clinical development program. So we will be extending some commentary on Thursday.

Suddenly boy.

Boy disclosing anything that we are discussing.

At the time of prior to that call.

Do you think that you.

Would be able to provide the.

The intended dose for the phase two and the scheduling of the administration of the drug interface to a trial.

Absolutely.

Reserve.

Full discussion on that until we are discussing all of those data, but we are dosing in our phase two study we're gonna be dosing.

Every other day regimen.

<unk> treatment, which is a seven day treatment interval.

We have a study design whereby we were doing a gated two part study awareness about 10 open label patients, yes, being administered and 110 for seven days and then as we absorb those readouts excuse me a lot of success with this approach and particularly in indications where there.

This is a clear large magnitude response and or where there are more objective.

Some measures and so.

That's a study that we've approached it at this point in time.

It's got to get that study up and running this quarter.

Yep Yep. Thank you.

If you have this at your fingertips, but do you know what the shares outstanding at the end of March.

Otherwise we can.

Yeah.

Yeah, but I believe that that is reported and will be in the 10, Qs I want to make sure that we.

We have that accurate, but it is.

Oh.

I'll give you an umbrella.

One second here Oh man, we can get to the different number.

Great.

I presume that you file your 10-Q.

Soon so corrected.

422 million shares roughly.

Okay.

Thank you so much Rob.

Thank you Oliver.

Our next question comes from Safra mentioned Sherry with eight capital. Please proceed.

Good morning, and thank you for taking my question.

My first question is about the.

Substance use program I, just want to understand as you're describing this payroll then I'm sure we'll gain more insight, but is the positioning of the gaps.

The positioning of the jobs that you're looking at in the current offerings are you look when you talk about the scale event in the highlighting of the gases that are more around the problem of <unk>.

Substance use.

Just want to understand that there'll be a comparison of the existing drug offerings. For example, or if this is more of an event around the problem at hand.

The opioid epidemic.

I see yeah. It's just so it's important to it it's a bit of both.

I would say in the sense that the.

The overall landscape, it's certainly critically important for us to understand given the <unk>.

Terrible tragedy, the opioid epidemic here in this country in particular, we just had recent data showing that.

And the last and last year they were.

Over 100000 believed cases from opioid overdose deaths.

That was really striking number and an incredible growth over the last.

Several years and so on.

Highlighting that backdrop as a starting point, but also it's critical to understand where in the treatment landscape we're seeing.

Significant challenges and where there's a gap that is resulting in.

That's the sort of being.

Under our airport and underserved.

With that we believe that it is in the.

Early phase of patients seeking treatment.

In the treatment of opioid withdrawal and the facilitation of getting those patients on to medication assisted therapy.

Such as.

You can work on our truck zone and.

That is why we're so excited about our approach in treating opioid withdraw their starting point will be in N Y 10 program. So it will be highlighting both the backdrop, but also the important gap in the treatment landscape and why we believe in how we're approaching to fill that gap with her and him onetime program.

Got it and I guess sudden going off of that do you see the.

In fact that you have a broader psychiatry pipeline in the us and the substance use program.

Are these all parts of our different divisions or do you see this as something that is more separate on its own that could be poised for partnering out given that it's.

Basically a separate program.

But certainly as we look at any of our.

So these are your targets or any of our programs where we're always.

Interested in having a dialogue with various potential partners just to explore what opportunities are and will continue to become available.

Our goal and our vision in terms of what we believe it's likely that a drug class and other novel targets can do is to treat beyond just psychiatry, but to treat.

The broader class of brain health disorders, which include.

<unk> indications use disorders pain neurology, but we believe that we are well poised to deliver on that full potential of this drug class.

That we would continue.

Testing approaching development opportunities.

Outside of simply psychiatry.

Certainly as we are progressing well.

Look towards getting deeper into clinical research programs and closer to.

Commercialization of these products.

There's always the opportunity with any individual program or disease area for selected partners to approach that would be.

But more focused on particular molecule or indications. So we keep all of those options open to ourselves.

It's certainly viewed the entire governmental component there I know like the N. I G. E does some work that's what I was trying to figure out with this K O all event and the fact that there is some.

Historical involvement from the government and.

And I D. A N in terms of the substance use programs like do you see potential for funding maybe off the back of this as a non dilutive source of funding for this program.

Yeah, well again, we're yeah, we're definitely looking at non dilutive sources of capital and ways to expedite and.

Maximize the impact and the ability of any of our program. So it's important to highlight that for instance, the <unk> program is not a psychedelic it is not a controlled substance at this time, nor do we anticipate it will be so it certainly has a bit of a broader and.

Less encumbered with the ability to generate government funded or.

Sources of capital.

Certainly.

Maybe just touching on the.

The Dod program as obviously, you got encouraging data.

On anxiety just wanted to understand the different I understand you'll be using a different scale.

Can you kind of touch on that and I guess, the confidence you're getting from the start data and I believe youre using a hamming.

Correct, Yeah, both of them and was behind me I guess encouraging already you guys I believe have that data as well.

So we Havent Hamilton Depression scale that was included in the E.

You H B study it would just run out.

The strategy that they use as the primary outcome measure and the Hamilton anxiety scale I think the.

The most important point to highlight there these are well established.

Outcome measures that have been used extensively we know a lot about both of them. We know about how they intersect ENT correlate and we have a high degree of confidence.

They are directly.

Correlated in there directly translatable.

I read through in our de risking.

The program and the clinical approach N J D. So.

While it while they are different measures.

If you look at the depression landscape. If you were to look at.

Number of scales that are available to handle and depression scale address.

Address for instance, when we see a high degree of correlation I think it's really important to note too that when we look at depression anxiety and B.

A large degree of symptomatic symptomatic overlapping sort of construct overlap both of them.

Disorders, and the outcome measures that are used to assess them disorders, it's important to see consistency and so we're doubling encouraged by seeing a response in the strategy and also in the Hamilton Depression scale.

We think that these learnings are a really important both for our G. A D approach, but also as we think about.

The potential utility of Asti intriguing product classes like gastric disorders.

Our term.

Understood and then just the last one for me do you anticipate providing.

Maybe an update on maybe 50% enrollment point I know.

First patient enrolled is typically.

Something I considered substantive material, but in this market win with zero delays I think.

The pace of enrollment itself is something that's been lacking visibility from a lot of companies have said is that something you guys have considered or an alternate form of update on maybe.

Maybe the cadence of enrollment.

Yeah, we haven't we haven't.

Got it that we will be doing so but absolutely.

Opportunities to provide update and clarity on progress of the study and from where we are in the progress of enrollment.

Important information and something that we'll keep a close eye on and make decisions as we progress in the study. So I certainly would share any of that publicly as soon it would be we want to make such a decision.

Okay. Okay. Thank you. Thank you for taking my questions.

And so on.

Next question comes from Tanya Armstrong with worth with Canaccord Genuity. Please proceed.

Good morning, guys just.

A couple of questions for me firstly on the E G B anxiety trial.

You want to see what the follow up period will be like how how long will you be monitoring these patients four after he does.

Yeah. Good morning so.

The study is designed to follow patients after a single administration for 12 weeks.

Primary endpoint measure it at four weeks after treatment.

Okay. So no date after 12 weeks, that's that's the definitive cut off.

In this study, yes, that's correct.

Okay.

And then with respect to project N. G are you going to be disclosing a chronic health indication that you're looking at.

Prior to the commencement of that trial in Q4.

And maybe just give us yes.

Lee.

Absolutely. So we anticipate starting that study in Q4.

We don't have any definitive release date, when we would be announcing the clinical design, but certainly as we approach it with prior to initiation that starting to provide additional clarity and would like to highlight.

Right.

The thought of historical data on the approach for why we're pursuing that so there will be certainly more to share about that program and have you approached with mi indication and the clinical approach.

And development program. So we're very excited to share more of that.

It would likely be.

So to the initiation of that study in the third quarter.

Okay.

And then lastly.

Thinking about I guess.

Costs, our investment allocation across our programs.

It's an idea of how much we should be thinking about allocating towards digital health.

Our drug program.

In terms of spend or in terms of the market.

Market potential.

In terms of spend.

Yeah. So certainly the vast majority of our costs are.

Directed towards our drug development programs with the digital programs.

Very important to highlight that where we see enormous opportunity and value that we can use those digital programs.

Silicate further adoption of our drug therapies that incremental market access and revenue growth in the long term wouldn't be meaningful.

Revenue and profit benefit to the organization so while while we do continue the digital programs and see enormous buy they do represent a small.

Small fraction of the costs that are being.

Outlaid in our R&D program.

Given our budget for the next couple of years on how much you want to allocate to those programs there or is that not something you do but.

So we certainly do have a.

Close budget, we managed very tightly but we start from them we have disclosed in great detail in terms of the allocation across those programs and in some ways. It will be also.

And by the criminal successes.

We continue to advance so I wouldn't want to give up too.

Too much further guidance on the exact amounts of allocation given that we have several important milestones.

Uh huh.

Read out there in the next 12 months.

Okay. That's fine that's it for me thanks, Rob.

Thanks, So much time here.

This concludes the question and answer portion of the call I would now turn the call back over to my met CEO , Bob Campbell for closing remarks.

Alright. Thank you so much and thank you everyone again for joining us this morning.

Before we conclude I'd also like to thank the entire mine med team, our investors and the many people who have been supportive to us along the way.

Our study participants and their families.

The time is now it has never been more important to deliver on the potential that we have in front of us to overhaul the treatment of brain health disorders, and we all remain deeply committed to making that potential reality.

Alright, Thank you again and I look forward to providing further updates on our exciting program has progressed throughout the year. Thank you everyone.

This concludes today's teleconference and webcast you may disconnect. Your lines at this time and thank you for your participation and have a great day.