Definium Therapeutics, Inc. (DFTX) Q3 2022 Earnings Report, Transcript and Summary

Good day, and welcome to the Mind Medicine Third Quarter 2022 Financial Results and Corporate Update Conference Call. [Operator Instructions]. As a reminder, this conference call is being recorded. It is now my pleasure to introduce your host, Robert Barrow, Chief Executive Officer and Director at Mind Medicine. Mr. Barrow, you may begin your conference.

Thank you, operator, and good morning, everyone. Welcome to MindMed's Third Quarter 2022 Financial Results and Corporate Update Conference Call. Prior to market open today, we issued a press release with a summary of our results for the third quarter of 2022. 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 September 30, 2022, is planned to 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. Miriam Wernli, our Executive President. During the course of today's call, I will provide an overview and update on our business. Then Schond will review financial results for the quarter ended September 30, 2022, followed by Q&A. Before we begin, let me remind you that during this conference call, we will be making forward-looking statements. Company's actual results may differ materially from those expressed in or indicated by such forward-looking statements. For a description of risks, please refer to our recent filings with the Securities and Exchange Commission. During the course of the third quarter, we continue to make significant progress across our business. Getting with MM-120 or LSD. In the third quarter, we dosed the first patient in our Phase IIb dose optimization study of MM-120 in the treatment of generalized anxiety disorder. Study enrollment has continued to progress according to plan, and we remain on target for a top line readout in late 2023. In September, results from the LSD ASSIST study, which is a Phase II placebo-controlled investigator-initiated clinical trial of LSD and the treatment of anxiety disorders was, conducted by our collaborators at University Hospital, was published in the peer review Scientific Journal Biological Psychiatry. Top line results in 46 patients with clinically significant anxiety demonstrated the significant rapid, durable and beneficial effects of LSD and its potential to mitigate symptoms of anxiety and depression. Enrollment in our Phase II proof-of-concept trial of low repeated administration of MM-120 in ADHD has also continued to progress and remains on track for a top line readout in late 2023. With respect to our MM-402, or R(-)-MDMA program, we continue to progress preclinical R&D efforts in preparation of the initiation of our Phase I clinical trial in 2023. Additionally, through our collaboration with University Hospital Basel, in the third quarter, we initiated a Phase I pharmacokinetic and pharmacodynamic investigator-initiated trial of RS and MDMA in healthy volunteers. This study seeks to assess 2 dose levels of R(-)-MDMA and 1 dose level each of and SDMA and, and we expect will provide valuable insights into the clinical activity of MM-402 as we progress our sponsor development program targeting core symptoms of autism spectrum disorder. Additionally, our external collaborations and early R&D activities have continued to progress, including the investigator-initiated study of LSD in the treatment of major depressive disorder being conducted at UHB. Our collaboration with lab at UHP continues to offer the opportunity to generate modern, high-quality data demonstrating LSD's clinical activity in brain health disorders. -- and continues to provide useful insights to inform the potential future direction in MM-120's development. We have continued the efforts disclosed in our second quarter earnings call to further streamline our operational and financial efficiency, and we continue to prioritize and focus our current development efforts and resources on MM-120 and psychiatric indications in MM-402. I would also like to take a moment to discuss our intellectual property position and strategy. As you are all aware, LSD and its form was discovered in the 1930s by Sandoz chemist, Hospital. Accordingly, IP is not available on our LSD free base. However, we believe we have made meaningful improvements in innovations on the original form of LSD and the development of our proprietary product candidate MM-120. This includes advancements both on the active pharmaceutical ingredient, LSD detartrate and dosage forms of LSD detartrate that we believe are optimized to meet modern pharmaceutical standards. In the third quarter of 2022, we converted several nonprovisional patent applications, which we believe could play a central role in the protection of MM-120. Should the claims and those applications be granted, their first X3 date will be in 2042. We continue to retain all rights to our intellectual property, clinical data and manufacturing rights that we have filed on our product candidates, and we'll continue to aggressively protect and expand our IP portfolio seeking to maximize the protection of our product candidates should they eventually be approved for marketing. I'll now turn to our platform of digital medicine products, which is strategically aligned with our drug development programs, and we believe has the potential to facilitate broad and diverse access to our product candidates. Under our MindMed Session Monitoring System, or MSMS platform, we have continued to advance our clinical studies and regulatory engagement in the pursuit of eventual approval for elements of MSMS as a software, as a medical device product. We look forward to providing further updates as we continue to progress our digital medicine strategy over the months ahead. We're incredibly pleased with the progress of our pipeline. And as we approach the end of 2022, we remain highly focused on the execution of our long-term plan and reaching key value-driving milestones, which are anticipated in the upcoming year. I will now turn the call over to Schond Greenway, our CFO, who will discuss our financial results.

Thanks, Rob, and thank you all for joining us today. We will now turn to our financial results for the third quarter ended September 30, 2022. As of September 30, 2022, cash and cash equivalents were $154.5 million compared to $133.5 million at December 31, 2021. During the quarter, the company regained compliance with NASDAQ listing requirements as well as completed financings through the use of our ATM facility and a public offering, which brought in an aggregate of approximately $60 million in gross proceeds. We believe these transactions not only brought in large life science institutional investors into the shareholder register, which displays their confidence in both our clear plan for value creation as well as our management team, but also enhanced and strengthened the financial position of the company away from the vagaries of the macroeconomic risks of the current equity markets. We believe that our cash and cash equivalents on hand positions us to accelerate and advance our proprietary pipeline into later stages of clinical development and will be sufficient to meet our operating requirements into the first half of 2025. Our net cash used in operating activities was $37.3 million for the 9 months ended September 30, 2022, compared to $38 million for the same period in 2021. Research and development expenses for the third quarter of 2022 were $7.8 million compared to $9 million for the third quarter of 2021. The decrease was primarily due to external costs related to MM-110 research program and a decrease in preclinical activities, which was offset by an increase in internal personnel costs as we continue to expand in-house research and development capabilities. General and administrative expenses were $9.2 million for the third quarter of 2022 compared to $8.2 million for the same period in 2021. The increase was primarily related to issuance costs related to the company's public offering, which closed during the quarter. The net loss for the third quarter of 2022 was $16.5 million compared to $17.2 million for the same period in 2021. Lastly, I wish to reiterate that we believe we are continuing to execute on a very efficient operation in terms of quarterly cash burn when compared to our largest peers in the space. As we have previously highlighted in our second quarter 2022 business update call, we intend to continue to conserve our cash, look for operational efficiencies, in particular our discretionary spending where we can, while also focusing and prioritizing our support to our most precious resource and development activities directed towards our key value drivers. I will now turn the call back to Rob, who will provide some closing comments.

Thank you, Schond. As we have demonstrated, the third quarter was marked by steady progress across our development pipeline. We have a highly talented and deeply committed team here at MindMed. We've continued to execute on our mission to be a leader in the advancement of novel treatments for brain health disorders. This concludes our prepared remarks, and I would now like to ask the operator to open the line for questions.

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

Congratulations on a good quarter of progress. I had a couple of questions. The first series on MM-120 and the second on R(-)-MDMA, I guess in terms of 120, thanks for the update, but I'm wondering if you could provide any additional color with regard to enrollment patterns, either in terms of patients beyond the first 1 or a few and then the number of sites. And if you could help us understand whether or not there is good investigator interest in this study.

Yes. We haven't provided and we're not in a position to provide specific guidance on the number of patients that have been enrolled to date, but enrollment has progressed well beyond the initial patient dosing that we announced in the third quarter. Additionally, we -- sites coming online have continued to progress as well. We have a very clear path. And I believe we will be in a position where all of our sites will be online in the very near term. In terms of investor engagement, we have very frequent engagement with our investigative sites with the session monitors who are actually conducting the delivery sessions of our MM-120 treatment sessions or the investigation drug treatment sessions, I should say. And we've seen an enormous amount of investor enthusiasm for the study. So we are really optimistic about the enrollment and continue to believe we'll be on track to hit our readout in this late part of 2023.

That's helpful, Rob. If I could ask 1 follow-up on 120, and that is in this investigator feedback that you referred to, have you heard any interest in other generalized anxiety disorder adjacency indications that you might consider looking at in the future that have even higher unmet need, if you will?

Yes. We've certainly heard both from our investigators and also from key opinion leaders, our Scientific Advisory Board that we just met with this week, an extraordinary level of engagement and excitement about the potential in a broad range of psychiatric indications. So while we are certainly very keenly focused on getting to a JV approval first, the comorbidity with depression is something that is top of mind for all investigators and all the CNS -- researchers and professions that have been working in this area. And we also -- as you all know, we have additional studies ongoing with University Hospital Basel, including a study of LSD and major depressive disorder, which we anticipate will have clarity on in terms of time line results in the coming months. So we're very excited to see the continued progress across other indications and to certainly look at the opportunity. We believe the historical data supports the potential beyond just anxiety disorder. There is certainly a massive need in JV, but also in other therapeutic areas where we believe there's a possibility of pursuing that indication at a later date. .

That makes sense to me, if I could hop over to 402 or R(-)-MDMA just quickly. I'm wondering if you could provide some of your perspective on the mechanistic rationale that may differentiate R versus S or MDMA. And then just a little more granularity on timing. I think that you said Phase I could be in 2023, which is a big range. So I'm wondering if you think first half or second half.

Yes. I'll ask Dan Karlin, our spec officer, to comment on mechanistically and have to add on to that. Dan, do you want to comment?

Yes, sure, happy to, and it's an excellent question. So when we look at the differential activity of RS and -MDMA and of course, we've seen it just being a mixture of the 2, SMDMA is attribution for dopaminergic effects of. So it seems like the S is largely driving both competitive activity doing via dopamine and some of the toxicity like hyperthermia and hyperactivity. And that's been demonstrated repeatedly in animal studies. So the R(-)-MDMA, an antimere, seems to be largely the serotonergic in MDMA and responsible for the prosocial and social perception, social communication effects of racemic MDMA. So given that the core symptoms of ASD that we're targeting really relate to social cognition and social communication, it seems clear to us that tumors is the right one to target those symptoms. The other thing that's worth pointing out is that the development paradigms currently for MDMA relate to as an adjunct for psychotherapy rate an enhancer of the process of psychotherapy. And we see our R(-)-MDMA program as being a different mechanistic action. So rather than enhancing second therapy for spectrum disorder, we see the R(-)-MDMA program as being more about the on drug effects in the real world proposed with ASD, so that on R and R(-)-MDMA, they'll be better able to engage in social behavior or social communication and have better social perception. So really it's a different -- kind of an entirely different target and a different paradigm, different dosing schedule and things like this.

And timing?

You covered it well, Dan. Yes, and Charles, to your question about timing. At this stage, it is certainly looking at -- we have the ongoing study with University Hospital Basel. We do have plans, and we plan to initiate the study in 2023. We would like to see some preliminary results and see if that alters our design or any of the outcome measures that we would what to add or an end in our planned Phase I study. And so we are going to be further refining those time lines and plans. We'll certainly communicate those in the not-distant future once the more precise time lines are available. .

And our next question comes from François Brisebois from Oppenheimer.

Dan on for Frank. I had a question just on the R(-)-MDMA program. I'm sorry if I missed this, but could you talk about the -- I think you mentioned 1 dose each of R and S and 2 doses of R and S. Could you just talk about the dosing strategy there? Any color there? .

Yes, absolutely. So this is a random mortar placebo-controlled double blinded crossover study. So there are 5 treatment arms, including the placebo. We're testing doses of 125 milligrams of racemic MDMA and S-MDMA and 125 milligrams and 250 milligrams of R(-)-MDMA. And so it's 24 participants, these 5 different investigational drug -- or drug levels will be administered in a randomly ordered sequence in the same patients who will get intra-patient responses, both in terms of PK and PD between and mixture.

Great. And in your MDMA study, are you sharing at this time what core symptoms Phase you're going to be looking at, like the trials in the past, social anxiety or any color there? .

Yes. So social anxiety is certainly the core feature of ASD that we believe would be most aligned mechanistically with MM-402 program, and also the one where we are focus based on the regulatory presence in the history of research in this area. So that is our current expectation that we would be using similar endpoints that have been used in the past for some breakthrough programs. But unfortunately, those programs didn't progress beyond pivotal studies. But we certainly believe mechanistically, our R(-)-MDMA represents a unique pharmacology and opportunity to advance in this population. We look at the historical endpoints and the historical indication language as our primary target for treating core symptoms. So that being principally social anxiety, which is the core targetable set of characteristics in ASD target.

Great. And finally, just in terms of the digital medicine products that you talked about. Are you going to be using any of these products with the ongoing trials? Are we going to see any preliminary data in terms of patient journey or any of that?

Yes. Great question. So we have ongoing studies, the digital medicine products. The products, in particular, that we are developing are not in use in our Phase IIb study of MM-120. We do have ongoing studies with our digital medicine products, both looking at a number of molecules, including ketamine and LSD and that's where our collaboration with the University Hospital Basel continues to be particularly important because given all of the ongoing research, we're able to include those digital medicine assets in some of those ongoing studies in University Hospital Basel, really gives us a unique opportunity to study both the effects of LSD and various indications and for its mechanistic activity, but also to generate robust data sets for our digital medicine products. And we've seen a really, really positive engagement with regulatory agencies that would put us in a position to really advance the CMD approach.

Our next question comes from Elemer Piros from ROTH Capital Partners.

Rob or Dan, would you please help us to understand what is your IP strategy with R(-)-MDMA or broadly speaking, if you cannot be any specific?

Yes, absolutely. It's a great question. And I think a lot of the discussion around intellectual property is fairly consistent across any of these molecules that have been researched in the past. There's certainly some basic R(-)-MDMA molecule that we discovered, clearly, right. MDMA has been studied for a long time and the 2 antimere been looking individually historically. That said, message of using R(-)-MDMA in indications, we have data that we have generated that certainly gives us excitement about our IP approach, both in terms of those methods of use, but also in terms of things such as formulation, intersection in our digital medicine intellectual property. And so as with most of these molecules and as it is outside of the second drug class and inside it, when there's a molecule that has been studied historically and there's not competition matter on the baseline API, we build a multilayered fortressed approach to protecting our market share and that we rely on marketing exclusivity from FDA, having patents that we believe are differentiated both in terms of the delivery, the formulation and the methods of use. And then getting those patent for Orange Book listed and utilizing the mechanisms available to us to get stay for any generic entrants and ultimately exercise any of the IP protection mechanisms, both inside and mediated by FDA and extra FDA IP protection for -- to us through the courts and the ability to take action against any potential entrants in a later date.

Okay. And would you be a little bit more specific of what sort of information would come out from the PK/PD trial conducted in Switzerland that would help you to design the Phase I.? What is your hypothesis there? .

Yes. absolutely. So what is our -- as was asked before, the core focus and treating core symptoms in autism disorder, social anxiety, and this is something where we see the processional effects of R(-)-MDMA in preclinical models. We know the recemic MDMA study in the clinic enhances prosocial engagement. And so our expectation, our hypothesis here would be that R(-)-MDMA would demonstrate that sort of prosocial effect in healthy volunteers. And it's important to highlight that while autism spectrum disorder is clearly an indication where there's a great unmet or no available therapy for the treatment of core symptoms of ASD, it is one where -- it is not a disease or like you would think of an underlying physiological condition that is totally distinct in terms of physiology from healthy volunteers. I know that, that's -- it certainly is an indication disorder that is, again, clinically relevant, has a major impact on patient lives. So I want to be clear that we certainly respect all of the implications of an ASD diagnosis. But unlike some indications such as oncology indication, where you couldn't understand the activity of an oncology drug in a healthy volunteer, which is a clinical activity. We believe that in the healthy once looking at those prosocial effects and by targeting the social communication skills, which are the -- again, the core focus of an ASD indication, that we would be able to potentially see those exact kind of pharmacodynamic effects in healthy volunteers. And we believe that based on this disorder, in particular, there's a reasonable likelihood of sort of read-through effect that we can glean from a Phase I study in healthy volunteers that would both informed the design and also potentially give us some positive preliminary signs of optimism at a minimum for the potential effects in treating social communication in ASD.

So do you believe that you might be able to -- based on the results from Basel that you might be able to go into a trial in patients -- in autism patients with our IND in the U.S.

Certainly, at some stage, some of that's going to depend on regulatory discussions that we have with the regulatory authorities in the countries where we potentially conduct our Phase I study. There's some times the ability to go into Phase I studies in patient population, that is not something that we have guided to or that plans to definitively. But certainly, we're looking to generate early signs of efficacy across indications as quickly as you possibly can. And the ability to get Phase I data and get PK/PD data in healthy volunteers with R(-)-MDMA at 2 different doses should be quite informative in terms of how we design our Phase I program in the population there, and as you mentioned, going into the ASD population by Phase II?

And our next question comes from Patrick Trucchio from H.C. Wainwright.

Just a couple of follow-up questions on the MM-120 program. First, I'm wondering if you can discuss some of the similarities and differences between the recently published Phase II placebo-controlled investigator-initiated trial with LSD and anxiety as compared to the MindMed's sponsored Phase IIb trial with MM-120 for treatment of generalized anxiety disorder? And how much of a read-through should we expect from this investigator-initiated study to the Phase IIb trial?

Absolutely. Thanks so much, Patrick. And I'll ask Dan to comment on the initial response. In terms of read-through effect, I think one thing that's really quickly important to sort of understand here is that the aggregate of clinical information is particularly important, right? So as you look back to the last 80 -- roughly 80 years of research on LSD, we've seen consistent responses and anxiety depression and neurotic illness. And this is in hundreds of patients in over 20 studies and a consistent response. And so we then see modern, high-quality, well conducted and more controlled unless you initiated so that confirms the historical effects, I guess this is a high degree of confidence and optimism. One of the differences in terms of the phase -- the IT conducted by Dr. Lathia at University Hospital Basel in our Phase IIb study, the number of elements are a bit different. But one of the special ones is the endpoint which she used, and so in their study they used the stating anxiety inventory, which is something that we believe from the literature is quite relevant in terms of demonstrating that we are seeing reduction in anxiety symptoms. The difference there is that it is not a regulatory endpoint. And so its utility in terms of being the basis for a regulatory application for approval is just frankly not there. We've had very productive discussions with FDA about where this would fit in the overall development and evidence space. And so because of the sort of this, of course, tension between what we now can see clinically and the observations from investigator-initiated studies, such as the one you mentioned by Dr., and what's required by FDA. So FDA require us to use the anxiety scale, which is the scale has been used historically for all anxiolytics. And that's what we are using in our Phase IIb study. Dr. again [indiscernible] endpoint. So from the literature, we also there's a high degree of response consistency. But while that gives us an incredible amount of internal comfort and optimism about the likelihood of success for our Phase IIb clinical trial. It really is an important point to emphasize that the nuance here is what's required by FDA and what that means in terms of the evidence base that we have today in their eyes. The other aspect I'll touch on briefly is that we are conducting -- from a design and statistical standpoint, what is a very patient and patient number, total number of subject efficient clinical trial design that allows 40 patients for across 5 arms, 4 different levels of LSD and -- excuse me, MM-120. And so that gives us an extraordinary opportunity to see the dose response in a patient population. Now we have seen historically, we've seen dose response in healthy volunteers in terms of the pharmacodynamic response, the PK response, generally the interesting things about a PD response. And when we measure it by the overall drug effect or the effect questionnaire is that we're being patients to -- or excuse me, in this case, we're actually help them on tiers, to quantify something that is supposedly inevitable, which is sort of a paradoxical thing. And so while it's also really important to emphasize the positive results we observed at a high dose level, the highest dose we're testing, 200 micrograms, and that was the dose used in Dr. study. So what we saw at the highest as we're testing a clinical response, it's critically important that we define the response on a regulatory endpoint in the population of interest in patients with generalized anxiety disorder, and that's what we're robustly doing in our Phase IIb trial. So it really -- it builds on the historical Phase I and Phase II investigator-initiated studies that we have exclusive access through Dr. collaboration with UHB. But it really ties this all together in our Phase IIb study with endpoints that we meet regulatory requirements, we believe, with a design that gives us a very efficient look at how we demonstrate clinical activity in this population of interest. And ultimately, with a clear path and a design that we believe will be leveraged into a pivotal program. So we have designed the Phase IIb study with the Phase III study in mind to believe that the evidence generation in this study would give us a very strong argument data set and a clear pathway to have negotiations with FDA about a program.

Yes. That's really helpful. And just as a point of clarification, just the decision to move ahead with the Phase IIb study instead of moving directly into a Phase III pivotal program, can you just talk about how those -- as those discussions with the FDA have been ongoing, why the program wouldn't have been able to kind of progress directly to a Phase III pivotal following that investigator-initiated trial?

Yes. Many of the points that I just mentioned are sort of the obvious factual basis. And I think certainly, we've had very productive regulatory engagements. We've have great regulatory expertise. I've had the good fortune of engaging with FDA and Division of Psychiatry on numerous occasions, right, in terms of developing the psychonomic drug class. And so that has given a clarity in terms of what is expected. I think you'd also look at one of our peer companies, Encompass Pathways. Obviously, they have their Phase IIb study, and they're still conducting 2 pivotal Phase III studies. So while in some disease areas, you might be able to jump right in the pivotal study. I've had these discussions directly with senior leadership in the Division of Psychiatry and FDA about what's going to be expected. They've given the field a nice opportunity to go straight into Phase II study. So it's important to remember, most of the times with drug development, you have to go into a preclinical package, in a Phase I and then you go to Phase II, and you do have 2 Phase II studies and then you're able to go to a pivotal study. So they've allowed us to go directly into Phase II without doing some of that historical work. But they've made it very clear that they expect a comprehensive data package at the time of NDA submission. And just at space, it's not realistic, and it's really sort of a naive thought that a program's first clinical trial could be the or one of the pivotal studies. This is not something that we believe is a realistic pathway for any molecule that's going to be used in a broad population in an indication that is highly prevalent that's going to have a lot of exposure in the real world.

Yes. That makes sense. And I had a follow-up actually, just the last 1 on you were coding to earlier, just around the COMP 360 program. And it's a different drug, different mechanism in PRD. Here we're looking at anxiety. But curious what the readthrough has been from the -- those discussions there and with the pivotal program now getting underway. And as well, just in terms of the number of patients that are having to be enrolled there in both the Phase IIb as well as the Phase III program, and presumably, this is as well to build up a substantial safety database as well. So I'm just curious, I mean your thoughts on kind of how the FDA is thinking about kind of pivotal programs with classic psychedelics? What read-through is there from COMP 360? And the number of patients that are going to be needed to build out that safety database?

Yes, another great question, Patrick. And certainly, there's -- we always try to rely on regulatory regulatory precedent is something that's particularly important in our field because FDA has, to an extent, or certainly have broadly way in terms of their discretion to the term the adequacy of a package and ultimately the approval of a marketing application. And we think psychiatry has done a really nice job at balancing the ability to allow -- enable research to progress at a good pace, but also require a robust data set. And it's something that as Dan Karlin and I came into MindMed at beginning of 2021, something that, from day 1 and from the first pre-IND engagement we had with FDA, which actually predated my employment, which was conducted in December of 2020, but I worked on closely with Dr. Halpin Worley. From that very first engagement, our approach has been to plan for a comprehensive research and development program. We believe that, that builds credibility both for our organization and build our -- the profile of both MindMed and the program with FDA and broadly with the entire stakeholders. And so our expectation is that we're going to be doing a comprehensive pivotal program. Now one of the things that is certainly important to emphasize is that strategy and geographic focus and the number of countries in which the trial has been conducted and ultimately seek marketing application and the sequencing of that also has an implication in terms of patient sizing and the design of clinical trials. So while we've gotten a read-through and clarity on what the Phase III program is, we don't have the regulatory minutes or knowledge of the discussions that have been had with FDA or other confident authorities, for instance, in European Union that would potentially inform how Compass, for instance, was thinking about their physical program. Certainly, we anticipate to conduct 2 pivotal clinical trials of MM-120 in generalized anxiety disorder. Again, had productive regulatory discussions. I believe we have a good degree of clarity in terms of the overall expectations. Those will be firmed up as we complete our Phase IIb study and based on the evidence we generate there and based on our continued regulatory negotiations, we will, in the Phase II meeting, certainly try to have greater clarity on exactly what our pivotal program would be. But whenever there's a presence established, we certainly pay very close attention and try to unpack the rationale. I think we would approach a few things a little differently, and we believe that MM-120 is going to have a multi-month effect, and we want to demonstrate what happens on -- over the acute course and over that longer duration. We've seen from the UHB study, many months of reduction in anxiety symptoms. And so we're highly confident in that many months response level at conform how we think about the core pivotal trial and how we think about other trials that may be required, either as part of the Phase III package or as a post-approval clinical trial that would inform what happens on the retreatment and the ability to maintain or retreat a potential relapse because these agents certainly are not going to be curative in all patients, and that would be an unreasonable expectation. So we need to develop a strategy for the long term, how we can safely and effectively both the acute situation but also maintain that effect over a period of time.

Our next question comes from Sepehr Monochehry from Eight Capital.

I noticed you mentioned some of the studies ongoing on the AMD side of things. And I want to get your thoughts on how that will wrap around into whether it's ahead of your Phase III program or is that something that's going to basically be in the package to then submit for potential REMS? Just trying to understand when that data and those studies kind of add value to the programs and how you think about the readouts there? .

Yes. So it's really important to emphasize that there are sort of 2 discrete pathways by which products are approved. And thanks so much for the question, I should say first. We obviously engage theater and the division of psychiatry for the development of our drug product candidates. And for our digital CMD products, we're engaged with CDRH and at least those that are being developed as CMD products. We're engaged with CDRH, which is the device division that reviews including -- any devices, including CMG products. We've had really productive engagement, including with joint meetings with CDRH and SEDAR, which has informed our overall development strategy, both in terms of the digital medicine products independently, but also our longer-term thoughts and strategy about how these digital CMD products could be integrated and married up with our drug products, in particular, MM-120. And so we have not given -- gotten to a point in those negotiations or regulatory discussions where we can say that there's a precise moment in time where we would include those 2 or trying to have them labeled together from a regulatory standpoint. But certainly, we are making rapid progress on the CMD device side of the equation and certainly have a view to include those and integrate those with our drug development strategy as we enter our pivotal study. So the sequencing of how those could be used, whether it's together -- labeled separately but used together in a real-world delivery setting, subject to both of those products being ultimately approved for marketing, or whether it's a sequenced approach to getting them co-labeled. That's something that's sequencing as well as top of mind and top of our regulatory discussions at this point. But something that we absolutely intend to do in the long term is to have our digital products directly integrated with the delivery of our drug products and so doing trying to address some of the key gaps in the delivery of psychonomic drug class. So things such as the high labor intensity that is required in clinical trials in the delivery of dosing session, the scalability. And we saw a recent article from commenting on the results of companies. One of the things we felt was a particular opportunity when we think about scalability, Dr. mentioned, in the real world, how tightly controlled clinical delivery, both in terms of psychotherapy and the labor-intensive observation is very hard to scale. And we agree with that view. We don't agree with some of the other points maybe. But we would certainly agree with the view that, that is something that needs to be addressed. And we believe the right approach to address that is by adding tools that can innovate and can allow the more efficient delivery of the drug. So if we were to say we're going to just try to scale a multi-hour highly degreed 2 individuals with medical degrees sitting in a room with the patient, that's going to be very difficult. But if we can come up with ways to safely make that process more efficient, make observation more efficient, make time of observation in the clinic more efficient and more personalized, these will be meaningful improvements that we believe would substantially enhance the drug uptake and would be -- really unlock the potential to deliver the psychonomic drug class and what we believe is our aim with our CMP products.

Got it. So that's kind of on top of mind in terms of pinning down the sequence there. In terms of the anticipated results around those, like I know the Q PEPS programs in use. Is that something that you anticipate in the coming year? Any of these in-use studies or the beta studies, and getting some data as to kind of the applications?

We certainly anticipate that across the digital programs we have, and in particular, the MSMS platform studies that we would be making announcements as we progress those programs. So we haven't given a precise quarterly guidance when those data would be. We will have certainly more to announce in the near term and -- are very excited to do so. I think when we make that announcement, it will be with a lot more -- with a lot of clarity in terms of the scope of the potential, the data we've been generating, and exactly how that dovetails both with our product candidates and with other substances that have perceptual effects, that have been approved by FDA and that require an observation period. So we believe our clinical research and some of the things will be in helping over the coming months would be very clear how it leverages current research was approved psychiatric therapies and how that could be a great analogy for how we can scale this into the utilization with our MM-120 product candidate in particular.

I look forward to that. And then just on the MM-120, I know you've talked about some of the wraparound, whether it's some of the digital health assets or things that you guys can do to differentiate your offering. I want to ask about trip stopper? I know Catanzaro was, I guess, in an investigator-initiated trial in the past that was completed. Is that something that could be paired with the kind of delivery that you guys think about, whether it's for the REMS program down the line or whether data for that could help in your filing eventually down the line? Like how do I think about that and how that falls into the MM-120 program? .

Yes. So at this point, we don't have an intent to have a co-labeled product with receptor antagonist. And here in the U.S. not approved. And the answer is by pharmaceuticals and there's certainly a potential that we could at some point in the future pursue further research there, and it's mechanistically quite interesting and important to understand if there is an ability to abruptly terminate the effects of -- the perceptual effects of MM-120 or other psychedelics that are serotonin agonists. But that would require -- in order to have that as a direct directly targeted for that use, would require clinical research and a label expansion or an initial labeling in the case of marketing applications in the case of. At this point, there's nothing that we're pursuing. We're always -- as we get more data, we'll obviously develop our strategy and research development plans accordingly. So as we have continued progress in the clinic and we get more data, that can certainly inform future direction. But at this stage, it is an interesting research study, but not something we have a product candidate we are actively developing.

Okay. Well, thanks for the insight there and congrats on the continued development progress. Appreciate the level of detail here.

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

Yes, thank you, operator, and really thank you everyone who joined us today and to all for the great questions. I'd also like to thank entire team, as we have a highly talented and dedicated team here at MindMed, and we're very grateful for their incredible efforts to advance our research and development programs. We thank our investors and all the people who have been supportive to MindMed along the way and continued to be supportive as on our strategy to provide meaningful impact in the development of navel treatment for brain health disorders. And I also want to thank the investigators and participants and their families. This is a -- we're doing research in populations that have significant impact, which is a massive unmet medical need, and we believe we can have a meaningful impact in this populations, and it can't be done without the dedicated researchers and the patients who volunteer their time and go through all of the extensive work in the clinical trial to conduct these studies. So a very direct thank you to all of them. We're very excited to continue our study, and we're very excited to the. So thank you all for being here today, and we look forward to running further updates soon.

This concludes today's conference call. Thank you for attending.