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spk07: Good day and welcome to the Mind Medicine third quarter 2022 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. You may press star 1 at any time during the call if you'd like to ask a question. 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.
spk08: Thank you, operator, and good morning, everyone.
spk06: 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 10Q for the quarter ended September 30, 2022, is planned to be filed today with the Securities and Exchange Commission. Joining me today is Sean Greenway, our Chief Financial Officer, Dr. Dan Carlin, our Chief Medical Officer, and Dr. Miriam Halperin-Wernley, our Executive President. During the course of today's call, I will provide an overview and update on our business. Then Sean 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. The 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. beginning with MM120 or LSD Detartrate. In the third quarter, we dosed the first patient in our Phase IIb Dose Optimization Study of MM120 for 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 that was conducted by our collaborators at University Hospital Basel was published in the peer-reviewed 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 two proof of concept trial of low repeated administration of MM120 and ADHD has also continued to progress and remains on track for a top-line readout in late 2023. With respect to our MM402 or RMDMA program, we continue to progress preclinical R&D efforts in preparation for the initiation of a 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 RMDMA S, and racemic MDMA in healthy volunteers. This study seeks to assess two dose levels of R-MDMA and one dose level each of racemic and S-MDMA, and we expect will provide valuable insights into the clinical activity of MM402 as we progress our sponsored 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 and the treatment of major depressive disorder being conducted at UHB. Our collaboration with the Leaky Lab at UHB continues to offer the opportunity to generate moderate, high-quality data demonstrating LSD's clinical activity in brain health disorders and continues to provide useful insights to inform the potential future directions in M120's development. We've 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 MM120 and psychiatric indications in MM402. I would also like to take a moment to discuss our intellectual property position and strategy. As you are all aware, LSD in its freebase form was discovered in the 1930s by Sandoz chemist Albert Hoffman. Accordingly, IP is not available on LSD freebase. However, we believe we have made meaningful improvements and innovations on the original form of LSD and the development of our proprietary product candidate, MM120. 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 non-provisional patent applications, which we believe could play a central role in the protection of MM120. Should the claims in those applications be granted, their first expiry date would 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 to reaching key value-driving milestones, which are anticipated in the upcoming year.
spk08: I will now turn the call over to Sean 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 30th, 2022.
spk06: As of September 30th, 2022, cash and cash equivalents were $154.5 million compared to $133.5 million at December 31st, 2021. During the quarter, the company regained compliance with NASDAQ listing requirements, as well as completed financings through the use of our ATM facility
spk08: and a public offering which brought in an aggregate of approximately $60 million in gross proceeds.
spk06: 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 fundamental 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 nine months ended September 30th, 2022, compared to $38 million for the same period in 2021.
spk08: Research and development expenses for the third quarter of 2022 were $7.8 million compared to $9 million for the third quarter of 2021.
spk06: The decrease was primarily due to external costs related to MM110 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.
spk08: 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.
spk06: Lastly, I wish to reiterate that we believe we are continuing to execute on a very efficient operation in terms of quarterly cash burn and compared to our largest peers in the space. As we have previously highlighted during 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
spk08: pressures, 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, Sean. As we have demonstrated, the third quarter was marked by steady progress across our development pipeline.
spk06: We have a highly talented and deeply committed team here at MyMed who have continued to execute on our mission to be a leader in the advancement of novel treatments for brain health disorders.
spk08: This concludes our prepared remarks, and I would now like to ask the operator to open the line for questions.
spk07: If you would like to ask a question, please press star 1 on your telephone keypad now, and you will be placed in the queue when you are received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star 1 on your phone now. And our first question comes from Charles Duncan from Cantor Fitzgerald. Please go ahead, Charles.
spk03: Yeah. Hi. Good morning, Rob, Sean. Thanks for taking our questions, and congratulations on a good quarter of progress. I had a couple of questions. The first series on MM120 and the second on RMDMA. 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 one or a few, and then the number of sites, and if you could help us understand whether or not there's good investigator interest in this study.
spk06: Yeah, thanks so much, Charles, and thanks for being here this morning for the question. 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, Enrollment has progressed well beyond the initial patient dosing that we announced in the third quarter. Additionally, 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 M-120 treatment sessions or the investigative drug treatment sessions, I should say. And we've seen an enormous amount of investigator enthusiasm for this study. So we are really optimistic about the enrollment and can continue to believe we'll be on track to hit our readout in this part of 2023.
spk03: That's helpful, Rob. If I could ask one 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 on that need, if you will?
spk06: Yeah, we've certainly heard both from our investigators and also from key opinion leaders in 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 GAD approval first, the comorbidity with depression is something that is top of mind for all investigators and all of the CNS researchers and professionals 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 in major depressive disorder, which we anticipate we'll have clarity on in terms of timeline results in the coming months. So we're very excited to see the continued progress across other indications and to certainly see look at the opportunity. We believe the historical data supports the potential beyond just general anxiety disorder. There is certainly a massive need in GAD, but also in other therapeutic areas where we believe there's a possibility of pursuing that indication of a later date.
spk03: That makes sense to me. If I could hop over to 402 or our 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 racemic MDMA, and then just a little more granularity on timing. I think that you said phase one could be in 2023, which is, you know, a big range. So I'm wondering if you think first half or second half.
spk06: Yeah, I'll ask Dan Carlin, our medical officer, to comment on mechanistically. I'm happy to add on to that. Dan, do you want to comment? Yeah, sure. Happy to. And it's an excellent question. So when we look at the differential activity of RS, MDMA, and of course racemic just being a mixture of the two, SMDMA has attribution for dopaminergic effects of racemic MDMA. So it seems like the S is largely driving both amphetamine-like activity via dopamine, excuse me, and some of the toxicity like hyperthermia and hyperactivity. And that's been demonstrated repeatedly in animal studies. So the RMDMA enantiomer seems to be largely the serotonergic enantiomer of MDMA and responsible for the prosocial and social perception and 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 the RNN tumor 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 its use as an adjunct for psychotherapy, right, an enhancer of the process of psychotherapy. And we see our RMDMA program as being a different mechanistic action. So rather than enhancing psychotherapy for folks with autism spectrum disorder, we see the RMDMA program as being more about the on-drug effects in the real world for folks with ASD so that on RMDMA, they'll be better able to engage in social behavior, social communication, and have better social perception. So it really is a different, kind of an entirely different target and different paradigm, different dosing schedule and things like this.
spk08: Very good, thanks. Any timing? You covered it well, Dan, thanks.
spk06: Yeah, and Charles, your question about timing, at this stage, You know, 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 want to add or amend in our planned phase one study. And so, We are going to be further refining those timelines and plans. We'll certainly communicate those in the not-distant future once the more precise timelines are available.
spk08: And our next question comes from Francois Briseois from Oppenheimer.
spk07: Please go ahead, Francois.
spk04: Hi. Thanks for taking the question. This is Dan for Frank. I had a question just on the RMDMA program. I'm sorry if I missed this, but could you talk about the, I think you mentioned one dose each of RNS and two doses of RNS. Could you just talk about the dosing strategy there? Any color there?
spk06: Yeah, absolutely. So this is a random mortar placebo-controlled double-blinded crossover study. So there are five treatment arms, including the placebo. We're testing doses of, excuse me, dosing doses of 125 milligrams of racemic MDMA and SMDMA and 125 milligrams and 250 milligrams of RMDMA. And so it's 24 participants. These five different investigational drugs or drug levels will be administered in a randomly ordered sequence in the same patient. So we'll get intrapatient responses both in terms of PK and PD on the two enatomers in the racemic mixture.
spk04: Great, thanks. And in your MDMA study, are you sharing at this time what core symptoms of ASD you're going to be looking at, like the trials in the past, social anxiety, or any color there?
spk06: Yes, social anxiety is certainly the core feature of ASD that we believed would be most aligned mechanistically with MM402 program and also the one where we are focused based on the regulatory precedent and the history of research in this area. So that is our current expectation that we would be using similar endpoints as have been used in the past for some breakthrough programs, but unfortunately those programs didn't progress beyond the little studies, but we certainly believe mechanistically RMDMA represents a unique pharmacology and an opportunity to advance in this population and look at this 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 that would be targeted with this indication.
spk04: Great. Thanks. 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?
spk06: Yeah, great question. So we have ongoing studies. The digital medicine products, the SAMD products in particular that we are developing are not in our Phase IIb study of MM120, 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 University Hospital Basel continues to be particularly important because given all the ongoing research, we're able to include those digital medicine assets in some of those ongoing studies in University Hospital Basel. It really gives us a unique opportunity to study both the effects of LSD and various indications for its mechanistic activity, but also to generate robust data sets for our digital medicine products. And we've seen a really positive engagement with regulatory agencies that would put us in a position to really advance the FAMD approach.
spk04: Thank you.
spk08: Thanks for taking my questions, and congrats on all the progress. Thanks, Ken.
spk07: Our next question comes from Elmer Piros from Roth Capital Partners. Please go ahead, Elmer.
spk05: Yes, good morning. Rob or Dan, would you please help us to understand what is your IP strategy with RMDMA, or broadly speaking, if you cannot be any specific?
spk06: Yeah, 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, you know, our MDMA is not a molecule that we discovered, clearly, right? MDMA has been studied for a long time. The two antihemers have been looked at individually, historically. That said, methods of using our MDMA and 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 with our digital medicine intellectual property. And so as with most of these molecules and as with outside of the psychedelic drug class and inside it, when there's a molecule that has been studied historically and there's not composition of matter on the baseline API. We built sort of a multi-layered fortress approach to protecting our market share, and that would 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 patents orange book listed and utilizing the mechanisms available to us to get stays for any potential generic insurance, and ultimately exercise any of the IP protection mechanisms, both inside and mediated by FDA and extra FDA IP protections that are afforded to us through the courts and the ability to take action against any potential insurance at a later date.
spk05: Okay. And would you be a little bit more specific of what – sort of information would come out from the PKPD trial conducted in Switzerland that would help you to design the phase one? What is your hypothesis there?
spk08: Yeah, absolutely.
spk06: So one of our, as was asked before, the core focus of treating core symptoms in autism spectrum disorder is social anxiety, and this is something where we see the pro-social effects of RMDMA in preclinical models. We know the racemic MDMA as it's studied in the clinic is described as an empathogen and enhances pro-social engagement. And so our expectation, our hypothesis here would be that RMDMA would demonstrate that sort of pro-social effect in healthy volunteers. And this is really important to highlight that while autism spectrum disorder is clearly an indication where there's no available therapies for the treatment of core symptoms of ASD. It is one where it is not a disease, so to speak, like you would think of an underlying physiological condition that is totally distinct in terms of its physiology from healthy volunteers. I know that that's It certainly is an indication, a 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 an oncology indication, where you couldn't understand the activity of an oncology drug in a healthy volunteer for a clinical activity, We believe that in the healthy volunteers, by looking at those pro-social effects and by targeting the social communication skills, which are, 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 read-through effect that we could clean from a phase one study in healthy volunteers that would both inform 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.
spk05: 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 in Basel? in your IND in the U.S.?
spk06: 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 sometimes the ability to go into Phase I studies in patient populations. 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 we possibly can. And the ability to get phase one data and get PKPD data in healthy volunteers with RMDMA at two different doses should be quite informative in terms of how we design our phase one program in the population we're there in. And as you mentioned, going into the ASD population, Yes.
spk08: Thank you so much, Rob.
spk07: And our next question comes from Patrick Trucchio from HC Wainwright. Please go ahead, Patrick.
spk01: Thanks. Good morning. Just a couple of follow-up questions on the MM120 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-sponsored Phase 2b trial with MM120 for treatment of generalized anxiety disorder, and how much of a read-through could we expect from this investigator-initiated study to the Phase 2b trial?
spk08: Absolutely. Thanks so much, Patrick. Thanks for the question.
spk06: And I'll ask Dan to comment on the initial response. In terms of read-through effect, I think one thing that's really critically important to sort of understand here is that, you know, the aggregate of clinical information is particularly important. As you look back to the last roughly 80 years of research on LSD, we've seen consistent responses in anxiety, depression, and neurotic illness. This is in hundreds of patients in over 20 studies. We see a consistent response. When we then see modern, high-quality, well-conducted, and well-controlled unless you're initiating a study that confirms those historical effects, it gives us a high degree of confidence and optimism. But one of the differences in terms of the phase, the IIT conducted by Dr. Leipzig at the University Hospital of Basel and our face-to-face study, the number of elements are a bit different, but one of the central ones is the endpoints used. And so in their study, they used the state-training 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 or 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 base. And so because of this, of course, tension between what we know can see clinically and the observations from investigator-initiated studies, such as the one you mentioned by Dr. Lichty, and what's required by FDA. So FDA is going to require us to use the Hamilton Anxiety Scale, which is the scale that's been used historically for all anxiolytics, and that's what we are using in our Phase IIb study. Dr. Lichty's study, again, uses the STI or the STI-G as the endpoint. So from the literature, we also know 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 2B 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 would 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 us to have 40 patients per arm across five arms, four different levels of LSD and 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. One of the interesting things about a PD response, And when we measure it by the overall drug effect or the mystical effect questionnaire is that we're asking patients to, or excuse me, in this case, we're asking healthy volunteers to quantify something that is supposedly ineffable, which is 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. Leakey's 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 builds on the historical Phase I and Phase II investigator-initiated studies that we have exclusive access to through Dr. Leakey and our collaboration with UHB. But it really ties this all together in our Phase 2B study with endpoints that 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 2B study with the Phase 3 study in mind and 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 the FDA about a pivotal program.
spk01: Yeah, that's really helpful. And just as a point of clarification, just the decision to move ahead with the Phase 2b study instead of moving directly into a Phase 3 pivotal program, can you just talk about, you know, 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, you know, following that investigator-initiated trial?
spk06: Yeah, many of the points that I just mentioned are sort of the obvious factual basis. And I think, you know, certainly we've had very productive regulatory engagements. We have great regulatory expertise. I've had the good fortune of engaging with FDA and Division of Psychiatry on numerous occasions in terms of developing the psychedelic drug class. That has given us clarity in terms of what is expected. I think you could also look at one of our peer companies, Compass Pathways. Obviously, they have their Phase 2B study, and they're still conducting two pivotal Phase 3 studies. While in some disease areas, you might be able to jump into a pivotal study, I've had those discussions directly with senior leadership in the Division of Psychiatry at FDA about what's going to be expected. They've given the field a nice opportunity to go straight into Phase II studies. So it's important to remember most of the time with drug development, you have to go into a preclinical package. You have to go to Phase I, and then you go to Phase II, and you do a few 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, you know, it's not realistic, and it's really a naive thought that, you know, 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 and an indication that is highly prevalent that's going to have a lot of exposure in the real world.
spk01: Yeah, that makes sense. And I had a follow-up, actually, just the last one on the point you were alluding to earlier, just around the COMP360 program. And it's a different drug, different mechanism, and PRD here, we're looking at anxiety. But I I'm curious what the read-through has been from 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 2B as well as the Phase 3 program. And presumably, this is as well to build up a substantial safety database as well. So I'm just curious on your thoughts on kind of how the FDA is thinking about, you know, kind of pivotal programs with classic psychedelics. What read-through is there from Comp 360? And, you know, the number of patients that are going to be needed to build out that safety database.
spk06: Yeah, another great question, Patrick. And certainly, you know, there's – we always try to rely on regulatory precedent. Regulatory precedent is something that's – particularly important in our field because FDA has, to an extent, has broad leeway in terms of their discretion to determine 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 enable research to progress at a good pace, but also require a robust data set. And it's something that as Dan, Carla, and I came into mind at the beginning of 2021, something that from day one 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. Halpern Wormley, 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 builds the profile of both MyMed and the program with FDA and broadly with the entire community of stakeholders. Our expectation is that we're going to be doing a comprehensive, pivotal program. One of the things that is certainly important to emphasize is that strategy and geographic focus and the number of countries in which a trial has been conducted and ultimately seeking 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 competent authorities, for instance, in the European Union that would potentially inform how Compass, for instance, was thinking about their program. Certainly, we anticipate to conduct two pivotal clinical trials of MM120 and 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 2B study. Based on the evidence we generate there and based on our continued regulatory negotiations, we will, in the Phase 2 meeting, certainly try to have greater clarity on exactly what our pivotal program would be. But whenever there's a precedent established, we certainly pay very close attention and try to unpack I think we would approach a few things a little differently. We believe that MM120 is going to have a multi-month effect, and we want to demonstrate what happens 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, many months effect. response level and that's going to inform how we think about the core pivotal trials and how we think about other trials that may be required either as part of the phase three package or the post-approval clinical trial that would inform what happens on 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 treat the acute situation, but also maintain that effect over a period of time.
spk09: That's really helpful. Thank you so much.
spk07: Thanks, Patrick. Our next question comes from Sapir Manocheri from Aid Capital. Please go ahead, Sapir.
spk02: Thanks, and good morning. Thanks for taking my question. I noticed you mentioned some of the Studies ongoing on the SAMD side of things and want to get your thoughts on how that will wrap around into whether it's ahead of your phase three program or if that's 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.
spk06: Yes, so it's really important to emphasize that there are two discrete pathways by which products are approved. And thanks so much for the question, I should say, first. We obviously engage feeder and the Division of Psychiatry for the development of our drug product candidates. And for our digital SAMD products, we're engaged with CDRH and those that are being developed as SAMD products. We're engaged with CDRH, which is the device division that reviews any devices, including CMD products. We've had really productive engagement, including with joint meetings with CDRH and CDER, which have 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 MM120. 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 two or try to have them labeled together from a regulatory standpoint. But certainly we are making rapid progress on the SAMD 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 sequence approach to getting them co-labeled. That sequencing is what is 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 in so doing, trying to address some of the key gaps in the delivery of a psychedelic drug class. So things such as the high labor intensity that is required in clinical trials for the delivery of a dosing session. The scalability, and we saw a recent article from Bertha Madras commenting on the results from Compass. One of the things we felt was a particular opportunity when we think about scalability. Dr. Madras 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. We agree with that view. We don't agree with some of the other points, but we certainly agree with the view that that is something that needs to be addressed. 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. If we were to say we're going to just try to scale a a multi-hour, highly degreed, two individuals with medical degrees sitting in a room with a 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 their clinic more efficient and more personalized, these would be meaningful improvements that we believe would substantially enhance the drug uptake and what would be really unlock the potential to deliver the psychedelic drug class and what we believe is our aim with our CMT products.
spk02: 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 QPEPS program is in use Is that something that you anticipate in the coming year, any of these in-use studies or the beta studies, getting some data as to kind of the applications?
spk09: Hello? Apologies.
spk06: We certainly anticipate that across the digital programs we have, and in particular the MS-MS platform studies that we would be making announcements as we progress those programs. So while we haven't given a precise quarterly guidance when those data announcements 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, you know, with a lot of clarity in terms of the scope of the potential, the data we've been generating and exactly how that 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 we will be announcing over the coming months would be very clear how it leverages current research with approved psychiatric therapies and how that could be a great analogy for how we can scale this into the utilization with our MM120 product candidate in particular.
spk02: I look forward to that. And then just on the MM120, 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 TripStopper. I know Catanzaran was, I guess, 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? How do I think about that and how that folds into the MM120 program?
spk06: Yes, so at this point, we don't have an intent to have a co-labeled product with serotonin 2A receptor antagonist. And here in the U.S., the answer is not approved. And the answer is, and by case, pharmacy schools and there's certainly a potential that we could at some point in the future pursue further research there. It's mechanistically quite interesting and important to understand if there is an ability to abruptly terminate the effects or the perceptual effects of NM120 or other psychedelics that are serotonin agonists. That would require, in order to have that as a direct directly targeted for that use. It would require clinical research and a label expansion or an initial labeling in the case of marketing applications in the case of cancer. At this point, that's not something we're pursuing. We're always, as we get more data, we obviously develop our strategy and research development plans accordingly. So as we have continued progress in the clinic and we get more data, that could certainly inform future direction. But at this stage, It is an interesting research study, but not from when we have a product candidate we are actively developing.
spk02: Okay. Well, thanks for the insight there, and congrats on the continued development progress. I appreciate the level of detail here.
spk07: Thanks so much, Todd. This concludes the question and answer portion of the call. I'll now turn the call back over to MindMed's CEO, Rob Barrow, for closing remarks. Rob?
spk06: Yes, thank you, Operator, and really thank you to everyone who joined us today and to all the analysts for the great questions. I'd also like to thank our entire team. As I said, we have a highly talented and dedicated team here at MyMed, 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 MyMed along the way and continue to be supportive. as we execute on our strategy to provide meaningful impact in the development of novel treatments for brain health disorders. I also want to thank the investigators and study participants and their families. We're doing research in populations that have significant impact. There's a massive unmet medical need, and we believe we can have a meaningful impact in these populations, and it can't be done without the dedicated researchers and the patients who volunteer their time and and go through all of the extensive work in a 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 for the year ahead. So thank you all for being here today, and we look forward to providing further updates soon.
spk07: This concludes today's conference call. Thank you for attending.
spk09: The host has ended this call. Goodbye.
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