Mind Medicine (MindMed) Inc (MNMD) 2022 Q1 法說會逐字稿

Good morning, and welcome to the Mind Medicine first-quarter 2022 financial results and corporate update conference call. (Operator Instructions) This call is being webcast live on investors and media section of my meds website at mindmed.co and recording will be available after the call.

For opening remarks, I would like to introduce Rob Barrow, CEO of MindMed. Please go ahead, sir.

Thank you, and good morning. I appreciate everyone joining us for our first-quarter 2022 financial results and corporate update conference call. The press release reporting our financial results is available in the investors and media section of MindMed's website. And our quarterly report on Form 10-Q for the quarter ended March 31, 2020, will be filed today with the Securities and Exchange Commission.

Joining me today Dr. Daniel Karlin, our Chief Medical Officer; and Dr. Miri Halperin Wernli, our Executive President.

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 candidates, 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 10-K. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 16, 2022. MindMed disclaims any obligation to update such statements even if management's views change.

Before we dive into our program and corporate updates, I would like to reemphasize our ambition to transform the treatment of brain health disorders by delivering on the therapeutic potential of psychedelics and other novel targets. We are applying our pharmaceutical expertise to developing innovative therapies with the aim of generating rapid and sustained improvement in patient outcome, with applicability to anxiety, addiction, and even autism.

This is more important now than ever. The good news is there has been a significant expansion in research to treat these conditions and MindMed is leading the way in this effort. In MindMed, we are utilizing decades of research to accelerate and derisk our three lead drug candidates: MM-120, MM-110, and MM-402, along with other novel therapies. We are extremely pleased with the progress of transformational growth that continues to propel our business forward and position MindMed 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 Karlin, to provide additional updates on each of our development programs. Dan?

Thank you, Rob.

Our drug pipeline at MindMed includes exciting drug candidates that are either currently in or are nearing clinical trials. On this call, I will focus on the programs with the most near-term visibility and highlight upcoming milestones starting with our lead drug candidate, MM-120.

MM-120 is a proprietary pharmaceutically optimized form of LSD that builds on extensive evidence of clinical benefit and mechanistic rationale (technical difficulty) in 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 dosing. We are developing MM-120 for the treatment of generalized anxiety disorder or GAD, attention deficit hyperactivity disorder or ADHD, and chronic pain.

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

Last week on May 11, Dr. Friederike Holze and Professor Dr. Matthias Liechti, MindMed collaborators at the University Hospital Basel, UHB, presented results from the LSD-Assist study, a Phase 2 placebo-controlled investigator-initiated trial with the LSD in the treatment of anxiety disorders at London's PSYCH symposium. Preliminary topline safety and efficacy 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 at a dose of 200 micrograms resulted in significant and strong reductions of global State Trade Anxiety Inventory or STAI-G scores 16 weeks after treatment in the between subjects analysis, with a statistically significant improvement from baseline compared to placebo. LSD thus well tolerated, only one serious adverse event was considered related to treatment and consisted of acute transient anxiety and delusions during an LSD session. There were no recorded instances of treatment-emergent suicidal ideation with intent, suicidal behavior, or intentional self-injury.

The trial was conducted at two centers: UHB Liechti Lab, and the psychiatry practice of Dr. Peter Gasser. We believe the results from the LSD-Assist study further support our clinical development of MM-120 in GAD.

As a reminder, in January of this year, the FDA cleared our investigational new drug application or IND for our randomized Phase 2b dose-optimization trial of MM-120 for the treatment of GAD. The trial plans to enroll a total of 200 participants will receive a single administration of up to 200 micrograms of MM-120 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 MM-120 across five treatment arms.

These events marked the start of the first large commercially sponsored study of LSD in more than 40 years. The results of this trial will guide the dose selection and development strategy for our pivotal Phase 3 clinical trials as well as deepen our scientific understanding of the clinical effects of MM-120 and its underlying mechanisms of action. 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.

In parallel, we continue to enroll patients for our Phase 2a proof-of-concept trial with MM-120 for the treatment of ADHD. In addition to our ongoing Phase 2 study for MM-120 in GAD and ADHD, we are currently advancing our strategic plans for MM-120 in the treatment of chronic pain. We plan to initiate a Phase 2a trial of MM-120 for chronic pain in the fourth quarter of 2022.

Moving on to our working 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, MM-110, also known as zolunicant or 18-MC, is an alpha-3-beta-4 nicotinic cholinergic receptor antagonist that has been tested extensively in preclinical models of withdrawal and substance use disorders. MM-110 has been shown to reduce signs of opioid withdrawal and reduce self-administration of opioid, stimulant, nicotine, and ethanol in preclinical models,.

Extensive pharmacology and toxicology studies have also shown MM-110 at a safety and tolerability profile that supports our clinical development program. We recently completed a Phase 1 trial of MM-110 in late 2021, which assessed the safety, tolerability, pharmacokinetics, and cognitive effects of MM-110 in healthy volunteers. In this Phase 1 single-ascending dose and multiple-ascending dose trial, subjects either will receive 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. 77 participants received MM-110, and 31 participants receive placebo. The result of this successful Phase 1 study in conjunction with the preclinical characterization of MM-110 has informed the Phase 2a 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 19, at 11:00 AM Eastern Time, and registration can be accessed through the investors and media section of management's 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 Dr. Dunn and get those presentations, we will provide an overview of MM-110 and its potential to address a key gap in the available treatments for opioid-use disorder.

I'll now turn to our third lead program, MM-402 or R(-)-MDMA, which is a synthetic enantiomer of MDMA that exhibits prosocial activity in preclinical models. We are developing MM-402 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. Preclinical studies of R(-)-MDMA demonstrate its acute prosocial effects, while its reduced dopaminergic activity suggested all of MDMA's favorable safety and tolerability profile compared to racemic MDMA or the S enantiomer.

Additionally, R(-)-MDMA 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. We are currently conducting IND-enabling studies to facilitate sponsored Phase 1 trials of R(-)-MDMA beginning in 2023.

Additionally, through our research collaboration with University Hospital Basel, we plan to initiate a comparative Phase 1 pharmacokinetics and pharmacodynamics trial of R, S, and racemic MDMA in healthy volunteers in the third quarter of 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.

In January of this year, we initiated the session monitoring system, SMS-01 study, which leverages the MindMed's 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 to 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 medication.

The launch of this study is an important milestone for our future development of regulated devices and software as medical device or CMD products that are designed to support novel analyses of multimodal data in the delivery of psychiatric care. This study will provide data that support the development of critical analysis algorithms, subsequent studies who intend to provide the evidence necessary for FDA clearance.

The second of our key active digital medicine efforts, which we call anxiety digital diagnoses for precision psychiatry or ADDAPT is a combination of a natural history study, which is to say that it follows a group of people over time who have or are 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 launched in private beta and are currently enrolling by invitation.

Our third key digital medicine effort, the quantifying the processes and events and psychotherapy at scale or QPEPS study, continues to enroll subjects at 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 inform all aspects on our program planning.

We believe our digital medicine products and projects could have monitoring and therapeutic benefits across a range of psychiatric disorders. By refining the techniques used to capture, model, and map the autonomic and behavioral outflow and other correlates of neural activity, we aim to improve the experience of clinicians and the outcomes for patients in the delivery of psychedelic and other perception-altering substances and psychotherapies. Our team is working 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. Miri Halperin Wernli, our Executive President, to discuss our exciting research collaborations and early-stage research and development activities. Miri?

Thank you, Dan.

With an aim towards accelerating our R&D efforts, we collaborate with leading research organizations around the world that provide valuable opportunities to advance novel treatments for brain health disorders. MindMed collaborate with a Liechti lab at University Hospital Basel in Switzerland; and has exclusive global rights to data, compounds, and patents, associated with their research program evaluating LSD, MDMA, mescaline, and DMT. This includes data from numerous completed and ongoing Phase 1 and Phase 2 studies.

This ongoing collaboration has generated a number of patent applications and has been invaluable in derisking and informing our drug development program. In addition to our UHB collaboration, we have an ongoing partnership with MindShift Compounds Limited in Basel, Switzerland on the drug discovery and optimization platform, developing and characterizing next-generation research compounds with all-related IT and pharmaceuticals technology owned outright by MindMed.

Lastly, our ongoing research collaboration with the Israeli drug-development organization Nextage Therapeutics seeks to explore the therapeutic utility have a proprietary brain-targeted liposome delivery technology to mitigate risks of systemic adverse effects with certain molecules such as noribogaine.

I will now turn it back over to Rob.

Thank you, Miri.

We will now turn to our financial results for the first quarter ended March 31, 2022. As of March 31, 2022, MindMed had cash, cash equivalents, and short-term investments totaling $120.5 million compared to $133.5 million as of December 31, 2021. MindMed believes its available cash and 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 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 non-cash expenses of $1.7 million of stock-based compensation expenses. This increase was offset by a decrease in external spending of $0.8 million related to our preclinical and other programs.

General and administrative expenses were $8.3 million for the 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 $0.9 million in non-cash 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 comprehensive loss for the three months ended March 31, 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 Lilienthal as our Chief Commercial Officer. He brings more than two decades of global biopharmaceutical experience from Merck, Janssen, and other organizations to support advancement of our clinical and commercial objectives.

I'm incredibly proud of the growth and numerous achievements across all areas of our organization. And I could 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 question.

Thank you. (Operator Instructions) Patrick Trucchio, H.C. Wainwright.

Morning and congrats on all the progress. I have a couple of follow-up questions on the MM-120 program. First, just I'm wondering what was seen with the safety and tolerability in the UHB (technical difficulty) was different in any way from historical studies conducted with LSD.

Secondly, can you discuss in further detail what read through from the UHB program and LSD could be expected to the Phase 2b trial for MM-120 in GAD and anxiety disorder? And were there any key differences or what are the key differences in the studies, including on the points that we should keep in mind as we look to that read through.

Absolutely, and thanks so much, Patrick. The UHB study that you're mentioning, as we said during the call was presented last week at the PSYCH symposium in London. And really, that's the most modern, highest quality study analysis ever conducted. It's really directly impactful on our program and does read through, does translate directly into the Phase 2 study we have ongoing and anticipate dosing our first patient in the coming months.

In terms of the adverse effect and adverse that we saw in the UHB study, there really was nothing inconsistent with the drug class or with LSD. When you look at the literature for both LSD and for all of psychedelic, commonly nausea, anxiety, and headaches, as with most drugs being higher up on the list, and that's really what we saw in terms of treatment-related events. The only SAE -- I think thi is particularly important, is the only serious adverse event that was observed was an acute transient anxiety or delusions in one patient. There was no suicidal -- suicide related SAEs or observed during the study.

So we obviously are very excited in light of those findings and whether that's due to the indication that the patient population and/or the specific activity of LSD or its potency, all of those could be quite positive as we progressed to our Phase 2 program.

In terms of the key differences and really the read through and how it informs. One of the things I think is most relevant is the fact that this study tested a 200-microgram dose of LSD. And we know that in comparison to what's been studied historically with psilocybin, that dose is even higher than most of the psilocybin studies. And one of the interesting findings that we saw from a psilocybin really high correlation and statistically significant correlation between the acute positive effect of LSD, and the clinical outcomes or reductions in Hamilton Anxiety Score.

It's not something that has really been reported extensively, a previous to the study and one that -- it's critically important because it provides some level of a proxy that we can use to target acute activity that we can anticipate correlates with that longer kind of corresponds. So very excited to see those data, and we'll use that to inform certainly how we think about acute activity and targets in our treatment sessions, both in the Phase 2 study and beyond as we continue to build the dataset.

So with that said, I think it's critically important to realize that the dose-response study that we are conducting in Phase 2b will go a very long way to further that understanding, but also to -- it gives us the best opportunity to see this desired effect in the most patients possible. Because of the incredible activity and premium and credible potency of LSD, it really gives us a unique opportunity to push the upper bounds and make sure that we are dosing appropriately, both for the magnitude of the acute effect and to enhance the likelihood of a durable effect.

So all of the data that -- the pharmacodynamic data that we observed, the correlations to clinical activity, but also the -- most importantly, the strong positive signs of [ecstasy] from this study that were statistically significant all read through and correlate with what we're doing in our Phase 2 program.

The one other difference I would highlight is that we are using the Hamilton Anxiety Scale as the primary endpoint. There is a good body of evidence from the literature that STAI-G and HAM-A are measuring the same thing and are correlated in terms of clinical response. But certainly the Hamilton Anxiety Scale is what we'll be using for a regulatory approval for general anxiety disorder that's in progress in the Phase 2 and Phase 3 program.

Yeah, that's really helpful. That was kind of part of my next question. So just specifically on the Phase 2b trial, at baseline, the patients are required to have a HAM-A greater than or equal to 20. So I'm wondering if you could, I guess, first tell us what other co-morbidities, if any, would patients be expected to have or what exclusions would there be for things such as depression or other co-morbidities or some proportion of patients expected to have some of those co-morbidities?

Secondly, what proportion of 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? What input from regulators was given? And then just finally, what is the study powered to generate in terms of improvement in the HAM-A?

Yeah, great. Great question. So I'll try to make sure I get all of those, Patrick. So in terms of the co-morbidities at baseline, we certainly anticipate that there will be diagnosis of major depressive disorder that will also come into the study. Of course, GAD needs to be the primary diagnosis, but the incidence of GAD and MDD co-morbidities is incredibly high. And so we certainly anticipate that it will be overlapped.

And importantly, that was the case in the UHB study as well, where we also saw statistically significant responses in the HAM-D and the BDI. So we saw reductions in both anxiety and depression in this UHB study which we think will translate into our Phase 2 program, hopefully, and even beyond that, as we look at of other co-morbid psychiatric indications.

The other psychiatric indications that would be excluded are those where there is a perceived risk with this drug class such as bipolar disorder, schizophrenia. There are certain indications that are going to be generally and categorically excluded I anticipate from, also within the psychiatric drug class because there are some historical concerns about using this drug class in those patient populations. But generally, as we look at this indication of GAD is an incredibly prevalent disease/disorder in our country. And one where we are trying to get a representative sample of this population where there is considerable amount of co-morbidity psychiatric disease.

Once again, another part of your question, I think -- make sure if I miss anything, please reach out to extend. But yes about the use of a placebo and input from regulators. In our Phase 2b study, we've design that as a five-arm treatment study. So there are four active arms of LSD and placebo is being used the fifth arm, the comparator. As you know, there's been extensive discussion around the use of an appropriate control and appropriate placebo condition in these studies.

And by using these five treatment arms, it actually gives us, we believe, the best opportunity to both learn from and observe the placebo response and placebo-controlled response and blinding because we have both a true placebo from here again. And we have a 25-microgram dose of LSD right at that dose of perceptual effect. Just at the sort of threshold level for LSD. 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 or pairwise comparisons against a true placebo, against an extremely low-dose active arm. And we think all of that will 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 which is directly relevant to our subsequent regulatory discussions before moving to pivotal studies.

And the last part of that -- go ahead, please.

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

Yeah. We really anticipate it being on the lower-end, low teens, perhaps 10%. That is not a strict target. That is just like a historical learning from other studies and looking at historical clinical trials in this space. So we don't have a hard rule about the percentage or hard target for the percentage of prior psychedelic keys. We do exclude patients who are showing a use pattern or something that would potentially 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 on the HAM-A, what kind of level of improvement from baseline-relative placebo are you targeting in the trial?

So one of the key things to note here is that the statistical analysis for the Phase 2 study is anticipated to be targeted on demonstrating the dose-responsive effect. So it is a methodology that's used to -- and very commonly in dose-optimization studies, to both pick 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 3 study. So we are powered to detect differences that would be in line -- at a minimum, in line with the historical standard of care and trying to improvement on those standards. If looking at the historical literature for anxiolytics, the effect sizes are somewhere in the 0.3 to 0.4 Cohen's D range, and we were anticipating or targeting to pick up clinical response that would be slightly greater than that. So it's something around the 0.5 range.

Got it. And if I could just one more on the program. At baseline, would patients have 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. Again, because this is a Phase 2b 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. Interviewing, we're certainly very focused on patients' medical and psychiatric history and medical -- medication history, which will inform how we progress further into development.

We are very interested, of course, in looking at subgroup analyses and actually complete the study and post-hoc analyses from our Phase 2b study, which would 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 the study.

Got it. That's very helpful. If I could just -- would just one on the MM-110 program. Just wondering what learning emerged from the MMED003 Phase (technical difficulty) trial that inform the design of the Phase 2a trial?

Obviously, the goal of Phase 1 is to define the safety and tolerability and pharmacokinetics of the molecule. And so looking at it, the data from both studies have been very important in terms of giving us clarity about the dose regimen and exactly how we want to progress this treatment.

It's also important in light, as Dan said during the call, in light of the very robust datasets we have from preclinical models where we observed just a single dose of an MM-110 can have a prolonged effect in 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 doses a day and every day for many days, will be preferable because there is patient compliance concern. And if we can demonstrate less-frequent dosing has a strong clinical, it will be very meaningful as a shift in the treatment landscape for opioid withdrawal.

Beyond that, we will be adding our KOL event this Thursday and are excited to share more about the treatment landscape and more about the program. I would really point to that event is where we share even further clarity on the learnings from our Phase 1 study.

That's great. Thank you so much.

Thanks, Patrick.

Michael Okunewitch, Maxim.

Hey, guys. Thank you so much for taking the questions. So I'd like to follow up on one of Patrick's questions regarding the UHB dataset in generalized anxiety. Specifically, are there any key differences between the UHB study in your ongoing Phase 2b in terms of the treatment protocol, the role of psychotherapy, or how you're actually recording the outcome measures such as the change in the anxiety scales?

Yeah. Thanks so much, Michael. So there are certainly some differences, and as you would expect, are translating into a commercial development program. We have a study design and methodologies that are standard for any anxiety program. In terms of the treatment regimen and psychotherapy, one of the most important things to highlight here is that the UHB collaboration and our partnership with both Dr. Liechti and his collaborators, Dr. Peter Gasser, has informed exactly what we are doing in terms of psychosocial support and safety and supported surround that goes along with treatment session LSD. So what we are doing in the clinic is very much informed by both historical practices involved. So worth noting that those practices are not limited to this LSD-Assist study that was just presented.

But in Switzerland, there's a long history. And currently, there's something along the magnitude of 30 psychotherapists who are able to provide LSD therapy to patients. And we use learnings from all of that, use to inform exactly what we're doing in our development program for LSD or MM-120. With that setting, it's important to note that how we frame, how we approach that therapeutics around for the delivery of the MM-120 sessions is going to be very important in terms of scalability, in terms of feasibility for labeling, and ultimately in terms of how we get this out into the world if we're successful in getting an MM-120 approved.

And so we have definitely packaged the psychotherapy -- excuse me, not psychotherapy, the therapeutics around and psychosocial support that is so much informed by those historical use in cases in the clinical trials. But we've presented it, both in terms of our approach in the clinical trial and into regulators, in a framework that is standard and more readily acceptable and adoptable, we believe, for treatment of psychiatric patients.

So all that said, it is not dramatically different. We still have patients who are brought in to be educated, who are overseen and monitored by their succession monitors during the treatment session, and then have follow-up visits. This is not a many-month psychotherapy program that we administer in our development program, but a package in a psychosocial surround that we believe is both adequate and based on historical evidence base that will be so important to bring forward into the clinic and actually into the world to patients.

In terms of how outcome measures that are collected. There's also certainly some methodological differences, nothing that -- I think as you look at it, multi-center study, we have approximately like 20 studies we're targeting for our Phase 2 study in 200 patients. Obviously, that scale requires some additional supporting and infrastructure. And so we do use a more centralized assessment of the [proactive] measures to trying to enhance that separation from those who are delivering care and those who are rating the outcome measures. And we also have unique sets of controls to monitor across all of our clinical endpoints to ensure the validity and access to the data across site.

All right, thank you very much. I appreciate the additional color. I'd also like to touch on your 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 FDA view pursuing CMD medical product in the clinical trial concurrently with the drug product? Are there any additional challenges or complications, and CMD somewhat implies a benefit to outcomes through the use of the software.

Yes. So important question, I want to make sure that we have clarity on this, is that we do have parellel development pipelines for our drug therapies and our digital therapies. So the CMD products that we are developing are not at the moment included in our clinical trials of an MM-120. We look to develop those independently. And then as we progress, there's always the opportunity to bring them back together, whether it's companion or -- companion use or combination products in the further future. At this time, we do not have them as integrated development programs whereby we're developing CMD products in our phased clinical research to MM-120.

All right. 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, does M&A represent an objective for MindMed at this time?

We're always interested in finding opportunities that will 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 here. Obviously keeping our eyes very much open in constant dialogue and exploration to keep identifying opportunities for that long-term expansion, or for near-term growth; and for ultimately, to build the most robust and strongest pipeline in this entire drug class or entire sector so we can drive that long-term value and deliver on our mission to be the leaders in developing brain health disorder treatment.

All right. Thank you very much. I appreciate you taking my questions.

Thanks, Michael.

Elemer Piros, ROTH Capital.

Yes, good morning. Rob. Just wanted to make sure that I heard it correctly that you would be presenting at this KOL event this Thursday, you wouldn't be presenting Phase 1 data on the [18-MC].

So yeah, we anticipate providing some additional clarity in terms of our development program overall and in terms of our recent findings and how that translates into our clinical development program. So we will be extending some commentary on Thursday and certainly fully disclosing anything that we are discussing at the time or prior to that call.

Do you think that you would be able to provide what the intended dose for the Phase 2 and the scheduling of administration of the drug in the Phase 2a trial?

I'd reserve full discussion on that until we are processing all the data. But we are dosing in our Phase 2, so we're going to be dosing every other day regimen for the duration of treatment, which is a seven-day treatment interval. And we have a study design whereby we're doing a gated two-part study where the Class 10 open-label patients being administered and then 110 for seven days. And then as we observe those readouts if we have a lot of success with this approach and particularly in indications where there is a clear large magnitude response and or where there are more objective outcome measures.

And so that's the study design we've approach at this point. We're excited to get that study up and running this quarter.

Yeah, thank you. And I don't know if you have this at your fingertips, but do you know what the shares outstanding at the end of March were? Otherwise we can (technical difficulty) this.

Yeah, I believe that that is reported in -- will be in the 10-Q so I want to make sure that we have that accurate, but it is -- I give you the number of. One second here, Elemer, we can get to that, to get that number.

It's, you know, I presume that you'll file your 10-Q soon.

Corrected, 422 million shares roughly.

Okay. Thank you so much, Rob.

Thank you, Elemer.

Sepehr Manochehry, Eight Capital.

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 the scale of and I'm sure we'll gain more insight, but is the positioning of the gaps that you're looking at in the current offerings; or are you look -- when you talk about this KOL event and the highlighting of the gaps, is it more around the problem of cyber substance use? Just want to understand that there will be a comparison of like the existing drug offerings for example, or if this is more of an event around the problem at hand like the opioid epidemic.

And yes, it is important -- it's a bit of both, I would say, in the sense that the overall landscape is certainly critically important for us to understand, given the terrible tragedy of the opioid epidemic here in this country in particular. We just had recent data showing that in the last year, there were over 100,000 believes cases from opioid-overdose deaths. Actually, a striking number and incredible growth in the last several years.

And so highlighting that backdrop is the 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 this is sort of being under cared for and underserved. And with that, we believe that it is in the early phase of patients seeking treatment. So in the treatment of opioid withdrawal and the facilitation of getting those patients onto medication-assisted therapy, such as buprenorphine or naltrexone. And that is why we're so excited about our approach in treating opioid withdrawal as a starting point with the MM-110 program.

So it will be highlighting both the backdrop, but also the important gaps in the treatment landscape and why we believe and how we're approaching to fill that gap with our MM-110 program.

Got it, and I guess, I'm going off of that, do you see the fact that you have a broader psychiatry pipeline in this asset and the substance use program? Are these are all parts different divisions or do you see this as something that is more separate on its own that could be a place for partnering out given that it's basically a separate program?

Certainly, as we look at any of our -- these are targets or any of our programs, we're always interested in having a dialogue with various potential partners just to explore what opportunities there are and will continue to become available. Our goal and our vision in terms of what we believe the psychedelic-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 includes a psychiatric indications, use disorders, pain, neurology. We believe that we are well poised to deliver on that full potential of this drug class, and that we would continue assessing our approach and development opportunities outside of simply psychiatry.

So that said, certainly as we progress and look towards getting deeper into clinical research programs and closer to our full commercialization of these products, there's always an opportunity with any individual program or disease area for selected partners to approach that would be more focused on a particular molecule or indication. So we keep all of those options open to ourselves and certainly view the entire --

Is there governmental component there? I know like the NIDA does some work. That's what I was trying to figure out with this KOL event and the fact that there is some historical involvement from the government and the and the NIDA 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?

Again, yeah, we're definitely always looking at non-dilutive sources of capital in ways to expedite and maximize the impact and the visibility of any of our programs. So it's important to highlight that, for instance, MM-110 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 income ability to generate government-funded or non-dilutive sources of capital.

Certainly. And maybe just touching on the GAD program, as obviously you got encouraging data on the anxiety. Just want to understand the different -- I understand, you'll be using a different scale. Can you kind of touch on that? And I guess the competency again from the STAI data and, I believe, you're using HAM-A.

Correct. Yeah. And both of these --

And then with the HAM-A, I guess, encouraging already. You guys, I believe, have that data as well.

So we had a Hamilton Depression Scale that was included in the UHB study that just read out. The STAI-G is the use of the primary outcome measure, and the Hamilton Anxiety Scale. I think the most important point to highlight there that 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 and correlate. We have a high degree of confidence that they are directly correlated and are directly translatable in terms of our read through in our view of derisking the program and the clinical approach in GAD.

So while they are different measures, I think -- if you look at the depression landscape, if you were to look at the number of scale that are available to Hamilton Depression Scale, an address, for instance, we see a high degree of correlation. But actually important to note too that when we look at depression, anxiety, and the large degree of symptomatic overlap to the sort of construct overlap, both of the disorders and the outcome measures that are used to affect those disorders. It's important to see consistency, and so we're doubling our courage by seeing a response in the STAI-G and also in the Hamilton Depression Scale. So we think that these learnings are really important, both for our GAD approach process. We think about the potential utility of LSD into the broader classes like psychiatric disorders over longer term.

Understand. And then just a last one from me, do you see providing maybe an update on maybe 50% enrollment point? I know first patient enrolled, that's typically something to add considered substantive and material. But in this module and with CRO delays, I think that pace of enrollment itself is something that has been lacking visibility from a lot of companies. So is that something you guys have considered or an alternate form of update on maybe the cadence of enrollment?

Yeah, we haven't guided that we will be doing so. But certainly opportunities to provide update and clarity on progress of the study and where we are in the progress of enrollment is important information, something that we'll keep a close eye on and make decisions as we progress the study. So I certainly would share any of that publicly as soon as we were to make such a decision.

Okay. Thank you for taking my questions.

Tania Armstrong-Whitworth, Canaccord Genuity.

Good morning, guys. Just a couple of questions for me. Firstly, on the Phase 2b anxiety trial, are you able to say what the follow-up period will be like? How long will you be monitoring these patients for after you dose them?

Yes. Good morning, Tania. So the study is designed to follow patients after a single administration for 12 weeks. The primary endpoint measured at four weeks after treatment.

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

In this study, yes. That's correct.

Okay. And then with respect to Project Angie, are you going to be disclosing maybe chronic health indication that you're looking at prior to the commencement of that trial in Q4? And maybe just give us a timeline.

Yes, absolutely. Absolutely. So we anticipate starting that study in Q4. We don't have a definitive or a release date when we would be announcing the clinical design. But certainly as we approach it with prior to initiation, then we will provide additional clarity and would like to highlight the thought and the historical data and the approach for why we're pursuing that.

So there will be certainly more to share about that program and the approach with the indication and the clinical approach and development program. So we're very excited to share more of that. It would likely be closer to the initiation of study, and we'll arrive there, fourth quarter.

Okay. And then lastly, thinking about, i guess, costs or investment allocation across your programs, could you give us an idea of how much we should be thinking about allocating towards the digital health versus drug programs?

In terms of spend or in terms of our market potential?

Yeah, in terms of spend.

Yeah, certainly the vast majority of our costs are directed towards our drug development programs. The digital programs that are very important to highlight that where we see enormous opportunity and value that if we can use those digital programs to facilitate further adoption of our drug therapies. That incremental market access and revenue growth in the long term would be a meaningful revenue and profit benefits to the organization. So while we do continue the digital programs and see enormous value, they do represent a small fraction of the costs that are being outlaid in our R&D programs.

Do you have a budget for the next couple of years on how much you want to allocate to those programs or is that not something you disclose?

So we certainly do have a cost budget that we manage very tightly. But it was something that we have disclosed in great detail in terms of the allocation across those programs and in some ways, it will be also driven by incremental successes and as we continue to advance. So I wouldn't want to give too much further guidance on the exact amounts of allocation given that we have several important milestones and readouts over the next 12 months.

Okay. That's fine. That's it for me. Thanks, Rob.

Thanks so much, Tania.

This concludes the question-and-answer portion of the call. I would now turn the call back over to MindMed's CEO, Rob Barrow, for closing remarks. Rob?

All right. 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 MindMed team, our investors, and many people who've been supportive to us along the way, including our study participants and their families. The time is now. It's 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.

Thank you again and look forward to providing further updates on our exciting program that 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.