Mind Medicine (MindMed) Inc

F:MMQ

Earnings Call Transcript 2023-Q1

[Operator]

Good afternoon, and welcome to the Mind Medicine First Quarter 2023 Financial Results and Corporate Update Conference Call. [Operator Instructions] This call is being webcast live on the Investors and Media section of MindMeds website at mindmed.co, and a recording will be available after the call. For opening remarks, I would like to introduce Rob Barrow, CEO of MindMed. Please go ahead.

[Robert Barrow, executive]

Thank you, and good afternoon, everyone. Welcome to our first quarter 2023 Financial Results and Corporate Update Conference Call. The press release reporting our financial results is available in the Investors & Media section of MindMeds website and our quarterly report on Form 10-Q for the quarter ended March 31, 2023, will be filed today with the Securities and Exchange Commission. Joining me today is Schond Greenway, our Chief Financial Officer; Dr. Dan Karlin, our Chief Medical Officer; and Dr. Miri Halperin Wernli, our Executive President. During today's call, we'll be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidates, financial projections and our future expectations, plans, partnerships and prospects.

These statements are subject to various risks, such as changes in market conditions, difficulties associated with research and development and regulatory approval processes that are described in the filings made with the SEC, including the most recent annual report on Form 10-K and quarterly report on Form 10-Q. Forward-looking statements are based on the assumptions, opinions and estimates of management of the date the statements are made, including the nonoccurrence of the risks and the uncertainties as we described in the filings made with the SEC or other significant events occurring outside of MindMed's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 4, 2023. MindMed disclaims any obligation to update such statements even if management's views change, except as required by law.

I would like to begin by reiterating our deep commitment to advancing our organization and delivering new life-changing treatment options to the many individuals living with brain health disorders. As we pursue our strategy to bring our lead product candidates to market, we believe we are laying the foundation to create lasting value for our shareholders. In the first few months of 2023, we continue to make steady progress across our pipeline, and we are well positioned to execute on our key priorities and reached multiple milestones throughout this year, including data readouts from our Phase 2b trial of MM-120 in the treatment of generalized anxiety disorder, or GAD, as well as from our Phase 2a proof-of-concept trial of repeated low dose in MM-120 and attention-deficit hyperactivity disorder or ADHD. Additionally, we expect to initiate the first clinical trial of MM-402 later in the year.

Before we dive further into our R&D and financial updates, I'd like to highlight the recently presented positive top-line data from the Phase II double-blind investor-initiated trial evaluating lysergide in the treatment of major depressive disorder, or MDD. This trial was led by Professor Matthias Liechti and Dr. Felix Muller, our collaborators at University Hospital Basel or UHB and the universal hospital psychiatry in Switzerland. As a reminder, we have exclusive global rights to data, compounds and patents associated with Professor Liechti's Lab research evaluating lysergide and other psychedelic compounds. This includes data from numerous completed and ongoing investigator-initiated trials in both healthy volunteers and patient populations.

Our collaboration has been particularly impactful by demonstrating and reinforcing the clinical potential of our drug development pipeline. Topline data from this investigator-initiated trial demonstrated significant rapid, durable, and beneficial effects of lysergide and has potentially to mitigate symptoms with MDD. Patients in this study received a 100-microgram dose of lysergide in the first dosing day, and a 200-microgram dose of lysergide in the second dosing day, which was separated by 4 weeks. An active small dose of 25 microgram lysergide was used as a control [ group ].

The trial on its primary endpoint at 6 weeks, which was measured by the change in clinician-rated inventory of depressive symptomatology or IBS-C scores. Further, the [Technical Difficulty] maintained up to 16 weeks, which underscores the potential long-term benefit of lysergide treatment. Data from the secondary endpoints were also encouraging and the investigational drug was similarly well tolerated. Given the high degree of comorbidity of MDD and GAD, the positive results and clinical activity of lysergide are particularly relevant to our MM-120 program. I'll now turn to updates on our R&D program, starting with our lead program in MM-120, a proprietary pharmaceutically optimized form of lysergide D-tartrate and development for the treatment of GAD and ADHD. GAD is [ an also ] debilitating mental health disorder associated with excessive anxiety and persistent worry, which can lead to significant impairment in social, occupational, and other functioning.

With very little innovation focused on the treatment of GAD, there's been a noted increase in the incidence and prevalence of individuals diagnosed with GAD in the U.S. and Europe over the past several years. Additionally, the number of patients who are not adequately treated by available therapies is also increasing. This is a result of the low rate of remission of multiple safety and tolerability challenges of SSRIs, SNRIs, antipsychotics and benzodiazepine. The research we've conducted with patients and healthcare practitioners in the U.S. and Europe tells there's a significant demand for a new pharmacological class that could offer a faster, more profound and more durable efficacy responses as well as favorable safety and tolerability.

This is particularly true in the segment of patients who despite having exhausted all available options continue to experience intolerable anxiety. Given the need for new treatment options, we are extremely encouraged by the growing data which supports the therapeutic potential of MM-120. Patient dosing and enrollment for our Phase 2b trial in GAD is progressing well across our 20 active sites, and we reiterate our expectation of reporting top-line results in late 2023. The trial frames will enroll a total of 200 participants who will receive a single administration of up to 200 micrograms of MM-120 or a placebo.

The primary objective of the study is to determine the reduction in anxiety symptoms for up to 12 weeks after a super administration in MM-120 across 5 treatment arms with a primary endpoint measure at 4 weeks post-dosing. The results of this trial will guide dose selection and development strategy for MM-120 and GAD as well as deepen our scientific understanding its clinical effects with underlying functional mechanisms of action. As mentioned, we are also evaluating MM-120 for ADHD. We expect to report top-line data through our Phase 2a trial in late 2023. Our Phase 2a trial is being conducted in collaboration with the University Hospital Basel in Switzerland and Masters University in the Netherlands and is designed to evaluate the therapeutic utility of repeated low doses of MM-120 in adult patients with ADHD. Notably, this is the first study in which MM-120 has been administered outside of the clinical setting.

To date, no SAEs have been reported suggesting the real-world potential of this treatment regimen as well as demonstrating our ability to deliver MM-120 with innovative dose and frequency combinations. In this trial, we expect to enroll a total of 52 participants who will receive a 20-microgram dose of MM-120 or placebo twice weekly for 6 weeks. The primary endpoint to the study are immune change from baseline ADHD symptoms as assessed by the [ AISRF ] after 6 weeks of treatment. This proof-of-concept trial is a component of our broader comprehensive MM-120 clinical development strategy, we explore both session-based administration harnesses perceptual effects of serotonin agonism, an innovative repeat administration regimen that harnessed a neuropharmacological effects of recurrent serotonin agonism.

The innovation of MM-120 and it session-based delivery approach is driven by its mechanism of action as a potent ceratin receptor agonist, which leads to profound sustained psychological effects. We believe MM-120 will be delivered as a single-dose pharmacological intervention that will only require occasional administration. We recognize the potential challenges in commercializing our product with such a revolutionary delivery profile and have embarked on a robust pre-commercialization plan, taken to educate all external stakeholders of the clinical and economic value of MM-120.

This is why one of the key priorities we are advancing in 2023 is to develop an innovative market access strategy, document the clinical and socioeconomic burden of GAD and ADHD and advance the generation of health economics and outcomes research data required to build a superior value proposition for our product candidates. As we progress our pipeline, we look forward to providing greater clarity on the commercial model and path forward for each program to maximize the reach of our novel product candidates.

As a reminder, with respect to our intellectual property strategy, our patent portfolio includes 26 pending U.S. applications and 12 pending PCT applications. These include applications covering compositions, dosing, dosage formulations and methods of treatment among others, with projected expiration dates beginning in 2021. Additionally, we continue to retain all rights to our product candidates and are aggressively protecting and expanding our intellectual property portfolio as part of our comprehensive market protection strategy.

Now I would like to turn to MM-402 or RDMA, which is a synthetic enantiomer MDMA with potential prosocial effects and a favorable tolerability profile. MM-402 is in development for the treatment of core symptoms of autism spectrum disorder, or ASD, which is characterized by atypical social communication and interaction, repetitive patterns of behavior and restricted interest. Despite a significant and growing prevalence, there are no therapies approved to treat the core symptoms of ASD. MDMA is a synthetic molecule that is also referred to as a pathogen because it is reported to increase feelings of connectedness and compassion. RDMA has sought to increased levels of serotonin and to a lesser extent, norepinephrine and other neurotransmitters in the brain, resulting in feelings of increased social ability in interpersonal emotional warrant.

Preclinical studies of RDMA demonstrated acute prosocial and pathogenic effect, while it's diminished from the merger activity suggest that it can exhibit less stimulant activity, neurotoxicity, hyperthermia, and abuse liability risk compared to the [ synthetic ] MDMA or the [indiscernible]. Our aim for MM-402 is to demonstrate its ability to enhance social engagement and interaction rather than having a sedating or blunting effect, which is often a result of currently used off-label medications in the ASD population. Importantly, our late-breaking abstract on the preclinical study of MM-402 in a model of ASD has been accepted for presentation at the 2023 American Society of Clinical Psychopharmacology Annual Meeting is being held in Miami Beach, Florida from May 30 to June 2.

With even further preclinical evidence to support our approach, we are extremely excited to initiate our Phase I clinical trial of MM-402 later this year. This trial is intended to characterize the tolerability pharmacokinetics and pharmacodynamics of MM-402, and we continue to explore all opportunities to generate early signs of efficacy as early as possible in development. We anticipate such data to be generated both in neurotypical healthy volunteers and in otherwise healthy individuals diagnosed with ASD. In parallel, through our research collaboration with University Hospital Basel, in 2022, we initiated and are currently enrolling healthy volunteers in a comparative Phase I pharmacokinetic and pharmacodynamic study of RS and racemic MDMA.

This study is designed to evaluate the tolerability pharmacokinetics and acute objective physiological and endocrine effects of the 3 molecules. We believe that successful completion will accelerate our understanding of the pharmacological profile and MM-402 as we advance into later-stage clinical development. Lastly, moving to our digital medicine update. Our drug development strategy is closely complemented by a suite of digital medicine program but has the potential to facilitate adoption, use and access to our product candidates. By refining the techniques used to capture, model, and map to autonomic and behavioral outflow and other core of our activities.

We improve the experience of clinicians and outcomes for patients and the delivery of psychedelics and other perception-altering substances. Our digital medicine programs are oriented toward applications during 2 primary clinical periods, activities during the treatment session referred to as intra-session and activities between treatment sessions referred to as intra-session. Each digital medicine program consists of a platform that contains separate underlying components, some of which we anticipate will be within the scope of FDA's definition of medical devices and others which we anticipate will not be regulated as medical devices.

For the medical device products, we intend to engage with the FDA and other international regulatory authorities to receive guidance along the development pathway towards a potential submission for regulatory clearance or approval. The ultimate goal of our digital medicine projects is to develop applications that overcome fictional point-of-care delivery to encourage user adoption across patients, providers and payers.

Overall, we are very pleased with the progress to date. As we advance our key clinical programs and execute on our corporate objectives, we continue to further strengthen the leadership of MindMed. We are very excited by the recent addition of Mark R. Sullivan, who's our Chief Legal Officer, Corporate Secretary. Mark brings extensive legal and public company life sciences expertise. It is a strong addition to our executive team. We believe Mark's experience and sighting guidance will prove them valuable as we progress to the next stage of MindMed's evolution.

I also have to highlight that as we approach our annual meeting in June, we are very excited by the potential of adding Dave Gryska to our Board. Dave brings him valuable insights from his 35 years of experience in the biopharmaceutical industry, including the service as CFO of 2 S&P 500 pharmaceutical companies, Insight and Celgene. Dave has also previously served on the Board of GW Pharmaceuticals before its acquisition by Jazz Pharmaceuticals for $7.2 billion and serves on the Board of Seagen, which recently agreed to be acquired by Pfizer for over $43 billion. Dave's nomination represents our ongoing commitment to Board refreshment and ensuring we have the optimal mix of experience and perspectives in the boardroom to help the company create value.

I believe Dave's involvement is an endorsement of the incredible people and organizations that we have built to find that as well as the potential impact of our products from the millions of individuals suffering from brain health disorders. I'd also like to express the board's gratitude of Brigid Makes who notified us that she will not stand for reelection at the annual meeting for their years of service to the early growth of the organization. Now is the time to radically transform how we treat brain health disorders, and we are deeply committed to realizing that potential for change.

With that, I will now turn the call over to our CFO, Schond Greenway, to discuss our financial results. Schond?

[Schond Greenway, executive]

Thanks, Rob, and thank you all for joining us today. We will now turn to our financial results for the first quarter ended March 31, 2023. As of March 31, 2023, our cash and cash equivalents totaled $129.4 million compared to $142.1 million as of December 31, 2022. We believe that our current cash and cash equivalents will enhance positions us to accelerate our preparation for moving quickly into our pivotal studies for our lead program, MM-120 and will be sufficient to meet our operating requirements beyond our key development milestones in 2023 and into the first half of 2025.

Our net cash used in operating activities was $13.3 million for the quarter ended March 31, 2023 compared to $12.9 million in the quarter end March 31, 2022. Research and development expenses were $12.6 million for the quarter ended March 31, 2023, compared to $10.2 million for the quarter ended March 31, 2022, an increase of $2.4 million. The increase was primarily due to increases of $2.9 million in expenses related to clinical research for the MM-120 GAD study, $0.9 million in expenses related to our MM-402 program and $0.2 million in internal personnel costs as a result of increasing research and development capabilities, which were offset by a decrease of $0.7 million in expenses related to our MM-110 program and a decrease of $0.9 million in expenses in connection with various external R&D collaborations.

General and administrative expenses were $8.3 million for the quarter ended March 31, 2023, essentially flat compared to the same quarter a year ago. Our net loss for the 3 months ended March 31, 2023, was $24.8 million compared to $18.5 million for the same period in 2022. Lastly, I wish to reiterate that we are continuing to execute on a very efficient operation in terms of quarterly cash burn and headcount when compared to our peers in the space. As we have highlighted during our prior business update conference calls, we intend to continue to be thoughtful with our cash while also focusing and prioritizing our support for our most precious resource development activities directed to our key value drivers. More specifically, we will review our discretionary expenses on a constant basis to ensure that we are seeking to capture value from operational efficiencies where we can.

I will now turn the call back to Rob, who will provide some closing comments.

[Robert Barrow, executive]

Thank you, Schond. We remain laser-focused on driving our key program forward, which includes advancing our MM-120 product candidate in GAD and ADHD to Phase II clinical readouts later this year as well as initiating our first clinical trial of MM-402. Additionally, our early R&D activities are progressing and our collaboration with the University Hospital Basel continues to offer the opportunity to generate early clinical evidence to inform our pipeline progression. I also want to extend my sincere appreciation and gratitude for the foundational work has brought us closer to advancing novel treatment for brain health disorders. In particular, I would like to thank our highly talented and deeply committed team here at MindMed, our investors and the many people who have been supportive a longer way, including our research participants and their families.

We are working tirelessly to deliver on our mission of transforming the treatment landscape for the many individuals who have brain health disorders who are underserved by today's available therapies. Finally, I'd like to remind everyone that the purpose of today's call is to discuss our first-quarter updates and the progress of our business, but we will not be addressing matters related to our annual meeting. We encourage all of our shareholders to review our definitive proxy statement that has been filed with the SEC and on SEDAR and to visit www.protectmindmed.com for updates pertaining to our proxy campaign.

With that, I'd like to thank you all again for joining today, and I'm happy to take questions.

[Operator]

[Operator Instructions] Your first question comes from Charles Duncan, Cantor Fitzgerald.

[Charles Duncan, analyst]

And also thanks for all of the clinical trial design details, particularly for 120 and ADHD and 402, that was helpful. I do have a couple of questions regarding MM-120 in GAD. I'm wondering with the sample size of, call it, $200 million, 5 arms, so about 40 per arm. I'm wondering if you could frame what you would like to see out of that study in terms of some of the effect sizes. And if you anticipate a full dose-response or would it be really bookended by placebo versus the highest dose? So tell us what you think would be good out of that 420 or out of that 120 study in GAD?

[Robert Barrow, executive]

Thanks, Charles. Thanks for the question and for joining us today. With respect to the size and the design of the Phase 2b study. So as you mentioned, 200 patients were anticipating enrolling across the 5 treatment arms, which for everyone, as a reminder, is doses of 25, 50, 100 or 200 micrograms or a placebo. Patients received a single dose and then are followed for 12 weeks. The study was designed in such a way where the statistical methodology we're using really gives us power across the entire spectrum. So we benefit from the response across the treatment segment. That methodology [ of it ] developed at Novartis and is something that ultimately is a 2-part statistical test, one that would test whether or not there is any treatment response at all in the second part of the test is we nominate candidate profiles, which would reflect exactly what you're getting to in terms of the type of dose-response on the magnitude, effectively the slope and the shape of that dose-response curve.

In terms of the maximum magnitude we anticipate seeing, we've really designed the study so that we can characterize the effect size and power a Phase III program, but our expectation was really set to demonstrate just anything at or above the standard of care. The same effect size for most of the available anxiolytics was around 0.3 to 0.5, whether you look at SRIs or diazepine. And so even if we saw a response of that magnitude, we would anticipate seeing a significant outcome. And that said, we certainly want to see an improvement over the standard of care and believe there's an opportunity to do exactly that.

So in terms of our expectations, we do want to fully characterize the response across the doses, both acutely and in terms of durability. I think it's particularly important to emphasize that by looking at multiple doses that we believe would be at or above within the therapeutic window that actually gives us important insights both in terms of magnitude and durability of response at those different doses and the subtherapeutic doses as we anticipated. So the design has been again to robustly power and detect the difference, but also to make sure we're characterizing adequately acute and durable response to power and design our Phase III program.

[Charles Duncan, analyst]

Okay. So that's helpful, Rob. So we should not consider that this is a pivotal program or a pivotal study and judge its outcome based on that. But that -- whether or not it's available to help you move forward into Phase III, correct?

[Robert Barrow, executive]

That's correct. It would be very much premature to consider this a pivotal study. Now it's certainly an important part. We've even seen a presentation by representatives and FDA at recent conferences, particularly the ECNP a few weeks ago about the importance of demonstrating dose response. And again, I think we, as a sector, setting this drug class, really need full comprehensive information and data sets before we go into a pivotal program that is going to be very efficient, very clean design as we anticipated today.

So it has been -- the Phase II study has been designed to give important insights in that design, characterize the response in this population which has not been done at the scale of this magnitude and really, no studies to date that we're aware of have looked at a comprehensive exploration of dose-response. So that is the intent of the study and ultimately, we believe that will give us both additional support for our ultimate clinical package, [ would be soon as an NDA ], but also would help us be very efficient with our Phase III design.

[Daniel Karlin, executive]

Very good. And then one quick perspective builder. On the recent CPT 3 codes, I'm wondering if you could provide your perspective on how you think the AMA's recent approval of first-step approval to establish CPT code to enable intermittent therapy that involves both the drug and a therapist if you have a perspective on that and how that may actually reduce the risk of not only approval but commercialization of these types of drugs.

[Robert Barrow, executive]

Thank I'll turn it over to Dan Karlin. He can actually like to answer that one.

[Daniel Karlin, executive]

Charles, Dan here. It's a really important question. Obviously, something we've been paying a lot of attention to as progress has been made in that CPT 3 code. As folks listening, we'll know the Level 3 codes are used for experimental and new services that have not yet been clearly approved or has a substantial vote of evidence behind them yet. Now we think this is an important step in the right direction, and we applaud [indiscernible] for the collaboration on getting to that point.

But we also know that while that code is specific to psychedelic services in general, it's a little applied to everybody across the board. In many cases, for existing parallel services such as the [ communicative ] administration, while there is an existing HS CTS Level 2 code or [indiscernible] to the services, many if not most commercial insurers are actually being billed for services like this under existing Level 1 codes. So there are a number of paths to coding success and obviously some official recognition from the [indiscernible] and then in the CPT is important. It's only one to delay on the process to having a fully robust cutting system that will cover all forms of third-party payers, including government and non-governmental commercial payers.

[Operator]

Your next question comes from Brian Abrahams, RBC Capital Markets.

[Brian Abrahams, analyst]

2 for me. I guess, first off on MM-120. As you think about how you might interpret the upcoming Phase II data, I'm curious your latest thoughts on how to find the best dosing window of dose levels that are going to maximize the benefit-risk profile. And I guess I'm curious if multiple doses are effective, would you move forward with 2 doses or more in Phase III? And I guess, how might you think about steering which dose might be appropriate for which patient and balancing efficacy with safety?

[Robert Barrow, executive]

It'd be a little bit premature to say specifically and obviously, we have many thoughts about how we generally think about safety and efficacy and the balance of benefit risk as we design a Phase III program. What I would say is that we are very much intent on being extremely efficient and clean in our study design and want to make sure that we have as direct of a path and efficient of a program as possible. So as we look to the data from this study, it is important to note, one of the things that's particularly exciting about the drugs we're working on and in 120 in particular, is that the acute administration seems to drive an acute and durable response.

And because of that, it does offer some advantages potentially in terms of the risk profile. So we wouldn't expect physiological risk to persist like what if you're taking a daily medication. So we'll certainly be monitoring outcomes, both efficacy and safety for the duration of the 12 weeks. We want to make sure that whatever dose we select to move forward in the Phase III is both responsive and in terms of efficacy, but also as well tolerated and we anticipate it would be safe as we get into a larger part of the development program.

With all that said, too, I think it's really important to note that based on the historical effect sizes, including the effects as we've seen from investigator-initiated studies, while they're preliminary, in part or up to a standard that would support being evidence for an approval necessarily those effect sizes are quite large. And so we would anticipate that even if we were to choose a dose with those better tolerated, let's say, just theoretically or had a similar response, we would be able to have a high degree of confidence, I think, based on the historical effect if we're also able to replicate that the size of the Phase III program would be adequate and it would give us plenty of patients to be able to demonstrate a statistical difference if we see a clinically meaningful response as we anticipate.

[Brian Abrahams, analyst]

That's really helpful. And then I guess, secondarily, with regards to the 402 program. You mentioned the study that's going to be looking at racemic DNA and the antimiRs in healthy volunteers in collaboration with UHP. I was wondering if you could elaborate a little bit more on that study. What specifically you're going to be looking for in terms of to better understand the pharmacology, the parameters you'll be exploring and when we might report data there? And I'll hop back in the queue.

[Robert Barrow, executive]

Yes. So in terms of the study design, it's 2 different doses of our MDMA, so 125 and 250 milligrams, a single dose of SMDMA and single dosemic MDMA. And this is inpatient, all the patients would be crossed over and received these different treatments. And in the 125 milligrams of S and the dosemic being administered here. So in terms of the outcomes that we're looking to, largely the pharmacy dynamic outcome. So overall drug effect in terms of intensity and duration, we're conducting as one of the primary outcome measures or I should say, Dr. Liechti's Lab disconnecting the 5-Dimensional Altered States of Conscious, the 5D-ASC scale. It's also investing functional perceptual activity of the [indiscernible] and racemic MDMA.

So we look at a number of autonomic effects, of mood effects, of course, characterizing pharmacokinetics and looking at other endocrine effects, levels of oxytocin, prolactin, cortisol, vasopressin. So many of the pathways that have been implicated in the activity of our or racemic MDMA to characterize that response with 2 different doses and ultimately seek to inform how we advance our own Phase I program and further into the clinical Phase II and beyond.

[Operator]

Your next question comes from François Brisebois, Oppenheimer.

[François Brisebois, analyst]

On the progress here. Just a couple here. In terms of the recent Hospital Basel study that you mentioned there, maybe if you can remind us just the differences here. So multiple doses comparison is not to a true placebo and obviously, a different indication, although similar comorbidities. So maybe just talk about the differences and how this could be a read-through towards your study? And any thoughts on patients, keeping them on SSRIs versus winding them off and what they can do?

[Robert Barrow, executive]

Great. So in terms of study design, this is an investigator-initiated study looking at the impact in patients with major depression disorder, patients in the active arm received 2 different doses that were separated by a month. The first was 100 microgram dose. The second was a 200 microgram dose, which again was separated by 4 weeks. The control group in this study was administered a 25-microgram dose both in the treatment days, both the dosing session. So it was not an inert placebo but we still did see a statistical and clinically meaningful differentiation between the response to those 2 doses.

So we saw a 3.6-point improvement in the IBS-C score, which is the inventory of depression symptomology score, 6 weeks after administration of the first treatment session for the low-dose arm, and we also saw a 12.9-point improvement on the IBS-C and the higher dose, 100 and the 200 microgram dose arm. Those effects remain durable up to 16 weeks, and we saw a number of encouraging secondary endpoints in the study.

So overall, we view it as particularly impactful and important given the relevance to depression, which is, of course, an area an indication where there's a huge growth and incidence and prevalence and one where they have -- we've also seen historical evidence of activity of LSD or lysergide. But it's also particularly important to note that there's a high degree of comorbidity between generalizing anxiety major depressive disorder, both in terms of diagnostic overlap, which we think is incredibly high, but also the number of patients the prevalence of diagnosis in [indiscernible] and population. So we think it's both relevant to our GAD program, but also opens up an opportunity.

We've seen historically strong, consistent responses in many studies and hundreds of patients with lysergide and anxiety and depression and other neurotic illness. And so this seems -- as consistent with the data we reported in anxiety back in 2022, again, demonstrating a strong statistically significant response after acute administration. What anyone hope to see in a depression study and something, again, we think is particularly important, both in anxiety and opens up the door to potentially having other indications in the future.

[François Brisebois, analyst]

Okay. Great. And can you remind me if the -- were the patients on SSRIs or whatever they were on or were they waned off to this trial?

[Robert Barrow, executive]

Yes. Some additional details about the specifics there will be forthcoming as the full publication is released. But generally, to comment broadly about your question, we don't have modern data to fully characterize the difference in either pharmacokinetics or pharmacodynamics think particularly more interest with oncology administration of SSRIs and a molecule like MM-120. But historical data has suggested that there may be an alteration of the PD profile, but we haven't seen any evidence where that would be alarming or a safety signal. So something we are certainly monitoring and no others and academic researchers have been interested in that differentiation of response. And so at as we progress in development, so we're going to be looking at very closely.

[François Brisebois, analyst]

Okay. Great. And then in terms of the R&D day that you mentioned would still be in the second quarter. Is that where you plan on sharing more details about your commercialization plans for each product? Or is that at a later time?

[Robert Barrow, executive]

As we think about an R&D Day in the second quarter, one of the key things we would like to highlight is an update on the progress of the clinical trial of our overall programmatic approach. We'll speak much more to the intellectual property and market protection strategy, and they got some important insights that should make it a very clear story to anyone who's been looking at market protection and the ability to protect a novel asset. So that will be one area of focus. We'll obviously dig into and have some key opinion leaders talking about generalizing value disorder as an indication and where the treatment might fit in the overall landscape. And then we also have an opportunity to present some individuals who have actively fund clinical trials and research with LSC, with the drug class generally and provide some insights into the commercial liability in that way.

I think certainly, as we progress and reach a Phase II readout and are getting into Phase II program, total clarity on what the path to our late-stage program looks like, we'll be in a position at that point to speak a little bit more about market access and the overall commercialization strategy. But certainly at our Investor Day coming up in the second quarter, we'll be giving a lot more insight into the status of the programs and I think greater clarity on some of the elements of our ultimate product that we try to take to market and our overall approach there.

[Operator]

Your next question comes from Elemer Piros, EF Hutton.

[Elemer Piros, analyst]

What I'd like to verify, Rob, is 20 clinical sites that you previously identified. Is this the final number for the GAD trial?

[Robert Barrow, executive]

The 20 clinical sites was certainly the number of sites that as we noted earlier in the year, were brought online and we're fully recruiting at the beginning of the year. And we've seen a lot of interest from a number of sites and a number of highly experienced sites. And as we think about site engagement and Brain sites online, they can both be driven by an individual study also programmatically. So we have an opportunity to engage with sites that might be great sites in a later stage Phase III program. So we're actively engaged with a number of discussions and a number of different avenues to make sure we can be as efficient as possible getting into that pivotal program. But certainly, 20 sites is where you started and [ 20 ] actually more in patients.

[Elemer Piros, analyst]

Yes. And at the end of the year, shall we expect primary endpoint information so efficacy at 4 weeks or maybe some later time points, 8 weeks and 12 weeks as you have those secondary endpoints?

[Robert Barrow, executive]

We certainly anticipate reading out at least as the top line readout, the 4-week data was the primary endpoint of the study. So we're giving greater clarity as we progress and give an update on the study in the future. But our expectation when we speak to the top-line results that we'd be at least reading out the primary endpoint.

[Elemer Piros, analyst]

Yes. And I just found this company called MindBio, who is doing or plan to do a micro-dosing LSD trial in MDD. Do you think that they would have freedom to operate if they continue to pursue that indication?

[Robert Barrow, executive]

In terms of intellectual property certainly in a research setting, there's a carve-out for doing research. So anything of that nature wouldn't come into play until a less layer down the road. But where we are positioned in the program and the support we've had, the team we've built, the efficiency we will have demonstrated as we get the readout by the end of this year, I think we'll make it very clear where everyone stands in the market who's likely to be first to market with any LSD product.

[Elemer Piros, analyst]

I see. And just last 2 small questions here. Do you have a cutoff value for the HAM-A score at baseline in the GAD trial or minimum severity?

[Robert Barrow, executive]

We do. I'll turn it over to Dr. Dan Karlin again.

[Daniel Karlin, executive]

I don't believe that we publicly disclosed that minimum cutoff score at the current time just to maintain trial integrity. So yes, we develop the score. But in general, just for integrity purposes, that [indiscernible] disclosed.

[Schond Greenway, executive]

I'll just expand on that real quickly. We have -- if we point you to our investor presentation, which published on our website, the minimum score we require to be enrollment trial as mentioned in the criteria is the Hamilton anxiety score of 20 or greater.

[Elemer Piros, analyst]

20 or greater. Okay. And do you expect a good portion of the patients to have depression as a comorbidity in this study?

[Robert Barrow, executive]

Based on the overall population, the comorbidity of GAD and major pressure or we certainly anticipate that the patients would have comorbid diagnosis with depression. What's critically important is to have a GAD as a primary diagnosis, but it would not be a representative population if you had an indication such as GAD, there wasn't some comorbid depression in the study.

[Elemer Piros, analyst]

But you are not examining efficacy based on reduction in depressive symptoms.

[Robert Barrow, executive]

Obviously, [indiscernible] are as secondary outcome measures, we're absolutely looking at response on standard depression scales and would use that as another important insight into the potential response and impression.

[Operator]

Your next question comes from Patrick Trucchio, H.C. Wainwright.

[Patrick Trucchio, analyst]

I'm wondering, as you look at the broader space of sponsors exploring psychoactive agents, how do you view the differentiation of MM-120 relative to some of these shorter-acting compounds like [ 5-MeO-DMT ]? Do you see the advantages primarily on the efficacy and potential duration of remission? Or is there also a potential to separate on safety and tolerability profile as well?

[Robert Barrow, executive]

So when we look at the history of research of this drug class as a drug developer, you want to see drugs that have a likelihood of demonstrating this -- or how benefit-risk profile that ultimately gets you to an application and approval and LSC is the most characterized drug over the entire class. There's certainly been a lot of discussion about shorter-acting molecules. What we know from the real world, I think it's important to highlight, there's a fairly large expanded access or capacitate use program that's ongoing in Switzerland. And our collaboration, both with Dr. Liechti UHB and more broadly with many of the psychiatrists in Switzerland has given us some real insights. These providers are able to utilize psilocybin or LSD.

And in many instances, when we have discussions about the preference, they choose to use LSD. They also have indicated on multiple occasions that the actual conduct of administration sessions, whether it's LSD or psilocybin, occurs for approximately the same duration. That's going to obviously vary by the individual. But we thought it was a particularly important insight that in practice in the real world, where this is being done regularly and has been done for several years, there isn't a significant differentiation between those 2 molecules. Now some of the ultrashort-acting molecules such as DMT or 5-MeO-DMT, these are certainly molecules that work on serotonin system. But what we need to characterize is both the acute and durable response, and that's what we certainly have seen more from historical data of LSD and gives us an extraordinary degree of excitement around the potential of our product candidates.

[Patrick Trucchio, analyst]

Can you talk more about the health economic outcome research that you referred to earlier? And understanding that there's still more planning here to be done. I'm wondering what would this potentially look like prior to the launch. And how big of a differentiator would it be for MM-120 if you have this type of data at the time of or soon after a potential launch?

[Robert Barrow, executive]

Yes. So I certainly don't want to speak too much of the specifics at this point, but we are actively engaged both with Francois Lilienthal, our Chief Commercial Officer, who's an incredible career and commercial launches, including most recently at Merck before coming over to MindMed to demonstrate the value proposition and make sure we have a path for commercialization for market access for reimbursement and also our digital medicine programs, which gives us an extraordinary opportunity to gather such data and engage in longer-term observational studies, both of patients with the disorders we are seeking to treat but also more specifically and some particular areas of research interest to us, both internally and through some of our collaboration. So we'll certainly be sharing more as we progress and as we get to have more clarity or share more clarity, I should say, on the commercialization pathway and also the plans will give us additional insights in terms of our approach to data generation and also the implications for market access pricing, reimbursement and such.

[Patrick Trucchio, analyst]

That's helpful. Just one last one for me. Can you talk about just broader strategic priorities as it relates to business development? And specifically, how do you think about potential partnership activity following the Phase II readouts for MM-120 later this year?

[Robert Barrow, executive]

Yes. We've certainly seen quite a bit of interest in our program and our readout and at any time where we were advanced to the point where [ we reach ] the disclosure threshold we certainly do so. But at this point, we do not have any business involvement or licensing or partnership agreements for subsequent development program. But again, we've seen, I think, a high degree of engagement and excitement both in terms of the serotonin system as a target, which is one of the best-characterized systems and all psychiatry, but also, in particular, in our program and our approach, the ability to generate the robust data and the consistency with which we're approaching our clinical development program.

Our Phase II study design and the way we've operationalized the study is exactly how we anticipate progressing into the Phase III program. And we think that gives us a great opportunity to transition out without changing any of the variables that are important in terms of conduct of the study and ultimately could impact safety or effectiveness. So there's been a lot of excitement across the board, and we'll keep any of our options open as it progress.

[Operator]

[Operator Instructions] There are no further questions at this time. I will now turn it back for closing remarks.

[Robert Barrow, executive]

Thank you, operator, and thanks, everyone, again for joining us today. We're extremely pleased with where we've come so far this year and are incredibly encouraged by moving very quickly to a data readout in late 2023 for our lead program and getting our [ second lien program ] and then MM-402 in the clinic later this year. Thanks, everyone, again, for joining us, and we look forward to sharing future updates.

[Operator]

Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating.