This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Good morning, and welcome to the MindMed Medicine First Quarter 2022 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. This call is being webcast live on Investor and Media section of MindMed's website at mindmed.co, and recording will be available after the call. For opening remarks, I would like to introduce Rob Barrow, CEO of MindMed. Please go ahead, sir.
spk10: Thank you, and good morning. I appreciate everyone joining us for our first quarter 2022 financial results in Corporate Update Conference Call. The press release reporting our financial results is available in the Investors and Media section of MyMed's website, and our quarterly report on Form 10-Q for the quarter ended March 31, 2022, will be filed today with the Securities and Exchange Commission. Joining me today is Dr. Daniel Carlin, our Chief Medical Officer, and Dr. Miri Halperin-Wernley, our Executive President. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential, safety, efficacy, and regulatory and clinical progress of our product candidates, financial projections and our future expectations, plans, partnerships, and prospects. These statements are subject to various risks that are described in the filings made with the SEC, including the most recent annual report on Form 10-K. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 16, 2022. MindMed disclaims any obligation to update such statements, even if management's views change. Before we dive into our program and corporate updates, I would like to reemphasize our ambition to transform the treatment of brain health disorders by delivering on the therapeutic potential of psychedelics and other novel targets. We are applying our pharmaceutical expertise to develop these innovative therapies with the aim of generating rapid and sustained improvement in patient outcomes with applicability to anxiety, addiction, and even autism. This is more important now than ever. The good news is that there has been a significant expansion in research to treat these conditions, and MindMed is leading the way in this effort. At MindMed, we are utilizing decades of research to accelerate and de-risk our three lead drug candidates, MM120, MM110, and MM402, along with other novel therapies. We are extremely pleased with the progress and transformational growth that continues to propel our business forward and position MindMed as a leader in developing novel therapies to treat brain health disorders. I will now turn the call over to our Chief Medical Officer, Dr. Daniel Carlin, to provide additional updates on each of our development programs.
spk08: Dan?
spk09: Thank you, Rob. Our drug pipeline at MyMed includes exciting drug candidates that are either currently in or are nearing clinical trials. On this call, I will focus on the programs with the most near-term visibility and highlight upcoming milestones, starting with our lead drug candidate, MM120. MM120 is a proprietary, pharmaceutically optimized form of LSD that builds on extensive evidence of clinical benefit and mechanistic rationality in psychiatry, pain, and substance use disorders. The tolerability, pharmacokinetics, and pharmacodynamics of LSD are well characterized with over 1,000 patients treated in clinical trials to date. Further, LSD has demonstrated the potential to provide rapid and sustained benefit after acute dosing. We are developing MM120 for the treatment of generalized anxiety disorder, or GAD, attention deficit hyperactivity disorder, or ADHD, and chronic pain. Beginning with our most advanced program, GAD is a debilitating mental health disorder that affects approximately 6% of U.S. adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persists for over six months that can lead to significant impairments in social, occupational, and other functioning. There has been very little innovation focused on the treatment of GAD over the past several decades. Last week, on May 11th, Dr. Friedrich Holtz and Professor Dr. Matthias Lichty MyMed collaborators at the University Hospital Basel, UHB, presented results from the LSD Assist study, a phase two placebo-controlled investigator-initiated trial of LSD in the treatment of anxiety disorders at Lutton's Psych Symposium. Preliminary top-line safety and efficacy results for LSD in 46 patients with clinically significant anxiety demonstrated the significant, rapid, durable, and beneficial effects of LSD and potential to safely mitigate symptoms of anxiety and depression. LSD in a dose of 200 micrograms resulted in significant and strong reductions of global state trait anxiety inventory, or SCI-G, scores 16 weeks after treatment in the between-subjects analysis, with a statistically significant improvement from baseline compared to placebo. LSD was well-tolerated, Only one serious adverse event was considered related to treatment and consisted of acute transient anxiety and delusions during an LSD session. There were no recorded instances of treatment-emergent suicidal ideation with intent, suicidal behavior, or intentional self-injury. The trial was conducted at two centers, UHB Lifty Lab and the psychiatry practice of Dr. Peter Gasser. We believe the results from the LSD-ASSIST study further support our critical development of MM120 in GAD. As a reminder, in January of this year, the FDA cleared our Investigational New Drug Application, or IND, for our randomized Phase IIb dose optimization trial of MM120 for the treatment of GAD. The trial plans to enroll a total of 200 participants who will receive a single administration of up to 200 micrograms of MM120 or a placebo. The primary objective of this study is to determine the reduction in anxiety symptoms for up to 12 weeks after a single administration of MM120 across five treatment arms. These events mark the start of the first large commercially sponsored study of LSB in more than 40 years. The results of this trial will guide the dose selection and development strategy for our pivotal Phase III clinical trials, as well as deepen our scientific understanding of the clinical effects of MM120 and its underlying mechanisms of action. With the study underway, we look forward to building on this momentum and progressing through the trial as quickly and efficiently as possible to address the unmet needs of patients who suffer from GAD. In parallel, we continue to enroll patients for our Phase 2A proof-of-concept trial to MM120 for the treatment of ADHD. In addition to our ongoing Phase 2 studies for MM120 in GAD and ADHD, we are currently advancing our strategic plans for MM120 in the treatment of chronic pain. We plan to initiate a Phase 2A trial of MM120 in chronic pain in the fourth quarter of 2022. Moving on to our working substance use disorders. there is a major unmet need to address the ongoing and ever-growing opioid crisis and provide effective treatment solutions for withdrawal management. Our proprietary molecule, MM110, also known as Linacant, or ATNMC, is an alpha-3, beta-4 nicotinic cholinergic receptor antagonist that has been tested extensively in preclinical models of withdrawal and substance use disorders. MM110 has been shown to reduce signs of opioid withdrawal and reduce self-administration of opioids stimulants, nicotine, and ethanol in preclinical models. Extensive pharmacology and toxicology studies have also shown MM110 to have a safety and tolerability profile that supports our clinical development program. We recently completed a phase one trial of MM110 in late 2021, which assessed the safety, tolerability, pharmacokinetics, and cognitive effects of MM110 in healthy volunteers. In this phase one, single ascending dose and multiple ascending dose trial, Subjects either received doses between 8 milligrams and 650 milligrams on one day, or daily doses between 4 milligrams and 180 milligrams per day for up to seven days. Seventy-seven participants received MM110, and 31 participants received placebo. The results of this successful Phase 1 study, in conjunction with the preclinical characterization of MM110, have informed the Phase 2a trial design that we plan to initiate in the second quarter of 2022. Earlier this month, we announced an upcoming Key Opinion Leader webinar on addiction and withdrawal management featuring presentations from Dr. Kelly Dunn, a professor at Johns Hopkins School of Medicine, and Dr. Stuart Gitlow, past president of the American Society of Addiction Medicine. This webinar will be held on Thursday, May 19th at 11 a.m. Eastern Time, and registration can be accessed through the Investors and Media section of MindMed's website. We look forward to this discussion about the current treatment landscape and unmet medical needs that exist in treating substance use disorders and managing opioid withdrawal. Following Drs. Dunn and Gitlow's presentations, we will provide an overview of MM110 and its potential to address a key gap in the available treatments for opioid use disorder. I'll now turn to our third lead program, MM402 or RMDMA. which is a synthetic enantiomer of MDMA that exhibits pro-social activity in preclinical models. We are developing MM402 for the treatment of the core symptoms of autism spectrum disorder, or ASD, which is a developmental disorder characterized by atypical social communication and interactions, repetitive patterns of behavior, and restricted interests. Preclinical studies of RMDMA demonstrate its acute prosocial effects, while its reduced dopaminergic activity suggests that it will exhibit a favorable safety and tolerability profile compared to racemic MDMA or the S enantiomer. Additionally, RMDMA has been shown to maintain prosocial effects with reduced stimulant activity compared to MDMA, and we believe may have the potential to be administered in a standard dosing regimen. We are currently conducting IND-enabling studies to facilitate sponsored Phase I trials of RMDMA beginning in 2023. Additionally, through our research collaboration with University Hospital Basel, we plan to initiate a comparative Phase I pharmacokinetics and pharmacodynamics trial of RS and racemic MDMA in healthy volunteers in the third quarter of 2022. Our drug development strategy is closely complemented by a platform of digital medicine products that have the potential to facilitate adoption, use, and most importantly, broad and diverse access to our therapeutic products. In January of this year, we initiated the Session Monitoring System, SMS01, study, which leverages the MindMed Session Monitoring System, or MSMS, to evaluate the passive collection of sensory data during a consciousness-altering therapeutic session. MSMS is a technological platform that provides the foundation for the development and implementation of a suite of products for use by clinicians and patients during treatment sessions that may also include the use of consciousness-altering medication. The launch of this study is an important milestone for our future development of regulated devices and software-as-medical device, or SAMD, products that are designed to support novel analyses of multimodal data in the delivery of psychiatric care. The study will provide data that supports the development of critical analysis algorithms. Subsequent studies will intend to provide the evidence necessary for FDA clearance. The second of our key active digital medicine efforts, which we call Anxiety Digital Diagnoses for Precision Psychiatry, or ADAPT, is a combination of a natural history study, which is to say that it follows a group of people over time who have or are at risk for developing an anxiety disorder, and a newly developed mobile application that we built specifically to support the study. The study and its supporting app have launched in private beta and are currently enrolling by invitation. Our third key digital medicine effort, the Quantifying the Processes and Events of Psychotherapy at Scale, or CUPEPS, study, continues to enroll subjects at participating psychiatric clinics. This study is providing a remarkably rich and robust dataset to enable a better understanding of patient progression, trends, and characteristics in the real-world treatment environment, and inform all aspects of our program planning. We believe our digital medicine products and projects could have monitoring and therapeutic benefits across a range of psychiatric disorders. By refining the techniques used to capture, model, and map the autonomic and behavioral outflow and other correlates of neural activity, we aim to improve the experience of clinicians and the outcomes for patients in the delivery of psychedelic and other perception-altering substances and psychotherapies. Our team has worked incredibly hard to advance these products into the clinic, and we remain dedicated to rolling out these novel approaches and improving psychiatric outcomes for patients. Overall, we are extremely excited about these advancements, and the value-driving milestones ahead. With that, I will turn the call over to Dr. Miri Halperin-Winley, our executive president, to discuss our exciting research collaborations and early-stage research and development activities. Miri?
spk00: Thank you, Dan. With an aim towards accelerating our R&D efforts, we collaborate with leading research organizations around the world that provide valuable opportunities to advance novel treatments for brain health disorders. MindMed collaborates with a LISTE lab at University Hospital Basel in Switzerland and has exclusive global rights to data, compounds, and patents associated with their research program evaluating LSD, MDMA, mescaline, and DMT. This includes data from numerous completed and ongoing phase one and phase two studies. This ongoing collaboration has generated a number of patent applications and has been invaluable in de-risking and informing our drug development program. In addition to our UHB collaboration, we have an ongoing partnership with MindShift Compounds Limited in Basel, Switzerland, on the drug discovery and optimization platform, developing and characterizing next-generation research compounds with all related IT and pharmaceutical technology owned outright by MindMate. Lastly, our ongoing research collaboration with the Israeli drug development organization Next Stage Therapeutics seeks to explore the therapeutic utility of a proprietary brain-targeted liposome delivery technology to mitigate risks of systemic adverse effects with certain molecules such as noribogaine. I will now turn it back over to Rob.
spk10: Thank you, Mary. We will now turn to our financial results for the first quarter ended March 31, 2022. As of March 31, 2022, IMED had cash, cash equivalents, and short-term investments totaling $120.5 million, compared to $133.5 million as of December 31, 2021. MyMed believes its available cash and equivalents will be sufficient to meet its operating requirements into 2024. The net cash used in operating activities was $12.9 million for the three months ended March 31, 2022, compared to $10 million for the same period in 2021. Research and development expenses were $10.2 million for the three months ended March 31, 2022, compared to $6.8 million for the same period in 2021. The increase of $3.4 million was primarily due to $4.4 million of internal expenses related to compensation costs for additional headcount, which totaled $2 million, and an increase in non-cash expenses of $1.7 million of stock-based compensation expenses. This increase was offset by a decrease in external spending of $0.8 million related to our preclinical and other programs. General and administrative expenses were $8.3 million for the three months ended March 31, 2022, compared to $7 million for the same period in 2021. The increase of $1.3 million was primarily due to an increase of $0.9 million in non-cash stock-based compensation expenses. Other contributors to the increase included professional services such as accounting, audit, legal, compliance, director and officer insurance, and investor and public relations and personnel costs to support growth of the company. The net and comprehensive loss for the three months ended March 31st, 2022 was $18.5 million compared to $13.8 million for the same period in 2021. Overall, the first quarter of 2022 was marked by steady progress across our drug and digital medicine pipeline. We continue to build a world-class pharmaceutical company and attract top talent at all levels of our organization. We recently announced the appointment of Dr. Francois Lilienthal as our Chief Commercial Officer. who brings more than two decades of global biopharmaceutical experience from Merck, Janssen, and other organizations to support advancement of our clinical and commercial objectives. I'm incredibly proud of the growth and numerous achievements across all areas of our organization, and I cannot be more grateful for the incredible people both within and outside our organization who make this critical work possible. With that, I'd like to thank you all for being here today, and I'm happy to take any questions.
spk01: Thank you. We will now conduct a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in a question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star one to ask a question at this time. One moment while we poll for our first question. Our first question comes from Patrick Truccio with HC Wainwright. Please proceed.
spk04: Good morning, and congrats on all the progress. I have a couple of follow-up questions on the MM120 program. First, just I'm wondering what was seen with the safety and tolerability in the UHB trial? Was it different in any way from historical studies conducted with LSD? Can you discuss in further detail what read-through from the UHB program and LSD could be expected to the phase 2B trial for MM120 in GAD and anxiety disorder? And were there any key differences, or what are the key differences in the studies, you know, including on the points that we should keep in mind as we look to that read-through?
spk02: Absolutely. So, thanks so much, Patrick.
spk10: The UHB study that you're mentioning, right, as we said during the call, was presented last week at the Psych Symposium in London and really the most modern, highest quality study of LSD ever conducted. I think it's really directly impactful on our program and does read through, does translate directly into the phase two study that we have ongoing and anticipate dosing our first patient in the coming months. In terms of the adverse effects and adverse events we saw in the UHB study, there really was nothing inconsistent with the drug class or with LSD. When you look at the literature for both LSD and for all of psychedelics, commonly you see nausea, anxiety, and headaches, as with most drugs being higher up on the list. And that's really what we saw in terms of treatment-related events. The only SAE, and I think this is particularly important, the only serious adverse event that was observed was an acute transient anxiety and collusion in one patient. There was no suicide-related SAEs or AEs observed during the study. So we obviously are very excited in light of those findings, and whether that's due to the indication, the patient population, and or the specific activity of LSD or its potency, all of those could be quite positive as we progress to our Phase II program. In terms of the key differences and really the read-through and how it informs, one of the things I think is most relevant is the fact that this study tested a 200-microgram dose of LSD. And we know that in comparison to what's been studied historically with psilocybin, that dose is even higher than most of the psilocybin studies. And one of the interesting findings that we saw from the study is a really high correlation and statistically significant correlation between the acute positive effects of LSD and the clinical outcomes reductions in Hamilton anxiety score. That's not something that has really been reported extensively previous to this study and one that is critically important because it provides some level of a proxy that we can use to target acute activity that we can anticipate correlate with that longer clinical response. So very excited to see those data and we'll use that to inform certainly how we think about acute activity and targets in our treatment sessions, both in the Phase II study and beyond as we continue to build the data set. And with that said, I think it's critically important then to realize that the dose response study that we are conducting in Phase IIb will go a very long way to further that understanding, but also to give us the best opportunity to see this desired effect in the most patients possible. because of the incredible activity and incredible potency of LSD, it really gives us a unique opportunity to push the upper bounds and make sure that we are dosing appropriately both for the magnitude of the acute effect and to enhance the likelihood of a durable effect. So all of the data, the pharmacodynamic data that we observe, the correlations to clinical activity, but also the, most importantly, the strong positive signs of ecstasy from the study that were statistically significant all read through and correlate with what we're doing in our Phase II program. The one other difference I would highlight is that we are using the Hamilton Anxiety Scale as a primary influence. There is a good body of, excuse me, a good body of evidence from the literature that the STI-G and HAM-A are measuring the same thing and are correlated in terms of clinical response, but certainly that the Hamilton Anxiety Scale is what will be using for regulatory approval for generalized anxiety disorder as we progress in the Phase II and Phase III programs.
spk04: Yeah, that's really helpful. That was kind of, you know, part of my next question. So just specifically on the Phase IIb trial, at baseline, the patients are required to have a HAM-A greater than or equal to 20. So I'm wondering if you could, you know, I guess first tell us what other comorbidities, if any, would patients be expected to have or what exclusions would there be for things such as depression or other comorbidities or some proportion of patients expected to have some of those comorbidities? Secondly, what proportion of these patients are expected to have any experience with psychoactive agents? And then how was the placebo or how is it being determined for the trial? What input from regulators was given? And then just finally, what is the study power to generate in terms of improvement in the HAM-A?
spk02: Yeah, all great questions. I'll try to make sure I get all of those, Patrick.
spk10: So in terms of the comorbidities based on, we certainly anticipate that there will be diagnoses of major depressive disorder that will also come to the study. Of course, GAD needs to be the primary diagnosis, but the incidence of GAD and MDD comorbidities is incredibly high, and so we certainly anticipate that will be overlapping. Importantly, that was the case in the UHB study as well, where we also saw statistically significant responses in the HAMD and the BDI. So we saw reductions in both anxiety and depression in this UHB study, which we think will translate into our Phase II program, hopefully, and even beyond that as we look at other comorbid psychiatric indications. The other psychiatric indications that would be excluded are those where there is a a perceived risk with this drug class, such as bipolar disorder. There are certain indications that are going to be generally and categorically excluded, I anticipate, from all studies in the psychedelic drug class because there are some historical concerns about using this drug class in those patient populations. But generally, as we look at this, indication. GAD is an incredibly prevalent disease disorder in our country and one where we are trying to get a representative sample of this population where there is considerable amount of comorbid psychiatric disease. Another part of your question, I think, make sure if I missed anything, please feel free to extend. But you asked about the use of a placebo and input from regulators. In our phase 2B study, we've designed it as a five-arm treatment study. So there are four active arms of LSD and an inert placebo that's being used as the fifth on the comparator. As you know, there's been extensive discussion around the use of an appropriate control, appropriate placebo condition in these studies. And by using these five treatment arms, it actually gives us, we believe, the best opportunities to both learn from and observe the placebo response and placebo-controlled response and blinding because we have both a true placebo, to compare again, and we have a 25-microgram dose of LSD right at that dose of perceptual effect, just at the threshold level for LSD. And so it does give us a really unique opportunity to see both the dose-response curve and to confirm that they're is a non-zero dose response curve. But it also allows us to do post-hoc analyses for paralyzed comparisons against the true placebo, against extremely low dose active arm. And we think all of that will be incredibly informative as we progress further into the development program. One of the things, a lot of the discussions historically with regulators around appropriate placebo controls are not informed by current high quality studies that would allow us to compare the different controls. And so, by generating some level of that evidence, it gives us valuable data, which is directly relevant to our subsequent regulatory discussions before moving to physical settings.
spk02: And the last part that I have here is – go ahead, please.
spk04: I was just going to say the proportion that would be expected to have experience with the psychoactive agents, what would that be?
spk10: Yeah, we really anticipate it being on the lower end of the low teens, perhaps 10%. That is not a strict target. That is just kind of historical learning from other studies and looking at historical clinical trials in this space. So we don't have a hard rule about the percentage or a hard target for the percentage of prior psychedelic use. We do include patients who show a use pattern or something that would potentially confound study results or be problematic in terms of their history of using psychedelics.
spk04: Right. And then just the last part of it was just around the powering for the study on the HAM-A. What kind of level of improvement from baseline relative placebo are you targeting in the trial?
spk10: One of the key things to note here is that the statistical analysis for the Phase II study is anticipated to be targeted on demonstrating the dose-responsive effect. It is a methodology that's used very commonly in dose-optimization studies to both demonstrate a non-zero response curve and confirm what that dose-response curve is prior to selecting an optimal dose to bring forward into Phase III studies. we are powered to detect differences that would be in line, at a minimum, in line with the historical standards of care and showing improvement on those standards. That is looking at, if you look at historical literature for anxiolytics, the effect sizes are somewhere in the 0.3 to 0.4 Cohen's D range, and we're anticipating or targeting to pick up clinical response that would be slightly greater than that, so something around the 0.5 range.
spk04: Got it. And if I could, just one more on the program. At baseline, would patients have been expected to have failed any prior treatments, including standard of care treatments?
spk02: We do not have that as a required entry criterion into the study.
spk10: Again, because this is a Phase IIb study, we feel it's important as with all drug development programs to take a rigorous approach to define the population but also gather data that can inform subsequent development in so doing we are certainly very focused on patients medical and psychiatric history and medical excuse me medication history which will inform how we progress further into development we are very interested of course in looking at subgroup analyses and after we complete the study and post-hoc analyses from our Phase 2B study, which would inform where we go in terms of patient selection and potential indication refinement as we progress further into development. We do not have any specific requirements going into this study.
spk04: Got it. That's very helpful. If I could just – I have just one on the MM110 program. Just wondering what learning, you know, emerged from the MSTD-03 phase trial that informed the design of the Phase 2A trial?
spk10: Yeah, obviously the goal of phase one is to define the safety and tolerability and pharmacokinetics of your molecule. And so looking at the data from those studies have been very important in terms of giving us clarity about the dose regimen and exactly how we want to progress this treatment. It's also important in light, as Dan said during the call, in light of the very robust data sets we have from preclinical models where we observed just a single dose of MN110 can have a prolonged effect in these preclinical models for self-administration. We also believe that in this population, a model where less frequent treatment can be given as opposed to multiple doses a day and every day for many days will be preferable because there is a patient compliance concern. And if we can demonstrate less frequent dosing has a strong clinical response, that would be very meaningful as a shift in the treatment landscape for opioid withdrawal. Beyond that, we will be having our KOL event this Thursday and are excited to share more about the treatment landscape and more about the program. And we really point to that event as where we share even further clarity on the learnings from our Phase I study.
spk02: That's great. Thank you so much. Thanks, Patrick.
spk01: Our next question comes from Michael Akunwich with Maxim. Please proceed.
spk07: Hey, guys. Thank you so much for taking the question. So I'd like to follow up on one of Patrick's questions regarding the UHB data set and generalized anxiety. Specifically, if there are any... key differences between the UHP study and your ongoing phase 2b in terms of the treatment protocol, the role of psychotherapy, or how you're actually recording the outcome measures such as the change in the anxiety scale?
spk02: Thanks so much, Michael.
spk10: So there are certainly some differences, as you would expect, translating into a commercial development program. We have a study design and methodologies that are standard for any anxiety program. In terms of the treatment regimen and psychotherapy, one of the most important things to highlight here is that the UHB collaboration and our partnership with both Dr. Lichty and his collaborators, Dr. Peter Gasser, have informed exactly what we are doing in terms of psychosocial support and the safety and supportive surround that goes along with treatment session with LSD. So what we are doing in the clinic is very much informed by those historical practices. It's also worth noting that those practices are not limited to this LSD assist study that was just presented. But in Switzerland, there's a long history, and currently there's something along the magnitude of 30 psychotherapists who are able to provide LSD therapy to patients. And we've used learnings from all of that use to inform exactly what we're doing in our development program for LSD, or MM120. With that said, I think it's important to note that how we frame and how we approach that therapeutics surround for the delivery of NM-120 sessions is going to be very important in terms of scalability, in terms of feasibility for labeling, and ultimately in terms of how we get this out into the world if we're successful in getting NM-120 approved. And so we have definitely packaged the psychotherapy, or excuse me, not psychotherapy, the therapeutics around psychosocial support that is so much informed by those historical use cases and clinical trials But we've presented it, both in terms of our approach in the clinical trial and to regulators, in a framework that is standard and more readily acceptable and adoptable, we believe, for treatment of psychiatric patients. So all that said, it does not dramatically differ. We still have patients who are brought in to be educated, who are overseen and monitored by dosing session monitors during the treatment session, and then have follow-up visits. This is not a many-month psychotherapy program that we administer in our development program, but a package and a psychosocial surround that we believe is both adequate and based on that historical evidence base that it will be so important to bring forward into the clinic and actually into the world to patients. In terms of how outcome measures are collected, there's also certainly some methodological differences. Nothing that I think as you look at a multi-center study, we have approximately 20 studies we're targeting for our Phase II study and 200 patients. Obviously, that scale requires some additional support and infrastructure, and so we do use more centralized assessment of the covalent measures to try to enhance that separation from those who are delivering care and those who are rating the outcome measures. And we also have extensive controls to monitor across all of our clinical endpoints to ensure the validity and consistency of those data across sites.
spk07: Thank you very much. I appreciate the additional color. I'd also like to touch on your digital medicine initiatives. If I understand correctly, it seems like for some of them they will be used in conjunction in the ongoing clinical studies. So how does the FDA view pursuing a SAMD medical product in a clinical trial concurrently with a drug product? Are there any additional challenges or complications since SAMD somewhat implies a benefit to outcomes through the use of the software?
spk10: Yeah, so important question, and I want to make sure that we have clarity on this, is that We do have parallel development pipelines for our drug therapies and our digital therapies. So the SAMD products that we are developing are not, at the moment, included in our clinical trials of NM120. We look to develop those independently, and then as we progress, there's always the opportunity to bring them back together, whether it's through companion or a companion use or combination products in the further future. At this time, we do not have them as integrated development programs whereby we're developing a SAMD product in our phase clinical research for MM120.
spk02: All right.
spk07: Thank you very much. And then I guess one more, just strategically, given where you are in terms of your strong balance sheet and where the markets have traded, Does M&A represent an objective for Minamint at this time?
spk10: We're always interested in finding opportunities that will be accretive to value for our shareholders and that will represent a nice addition to our pipeline. Certainly, as we've seen the market landscape and other opportunities, we're always keeping our eyes very much open and in constant contact dialogue and exploration to seek to identify opportunities for that long-term expansion, for near-term growth, and for ultimately to build the most robust and strongest pipeline in this entire drug class and entire sector so we can drive that long-term value and deliver on our mission to be the leaders in developing brain health disorder treatment.
spk02: All right. Thank you very much. I appreciate you taking my questions.
spk01: Thanks, Michael. Our next question comes from Elmer Piros with Roth Capital. Please proceed.
spk05: Yes, good morning, Rob. I just wanted to make sure that I heard it correctly that you would be presenting at this KOL event this Thursday. You would be presenting Phase I data with AT&MC?
spk10: So, yeah, we anticipate providing some additional clarity in terms of our development program overall and of our recent findings and how that translates into our clinical development program. So we will be extending some commentary on Thursday and certainly fully disclosing anything that we are discussing at the time or price of that call.
spk05: Do you think that you would be able to provide what the intended dose for the phase two and the scheduling of administration of the drug in the phase two A trial?
spk02: Absolutely.
spk10: I reserve full discussion on that until we are discussing all of this data, but we are dosing in our phase two study, we're going to be dosing every other day regimen for the duration of treatment, which is a seven-day treatment interval. And we have a study design whereby we're doing a gated two-part study where we have 10 open-label patients being administered MM110 for seven days and then As we observed those readouts, we've seen a lot of success with this approach, particularly in indications where there is a clear large magnitude response and or where there are more objective outcome measures. That's a study design we've approached at this point and are excited to get that study up and running this quarter.
spk05: Thank you. I don't know if you have this at your fingertips, but do you know what the share is outstanding at the end of March? Otherwise, we can .
spk10: Yeah, but I believe that that is reported and will be in the 10Q, so I want to make sure that we have that accurate.
spk02: But it is, I'll give you the number. I'll give you one second here, Elmer, and we can get to the definite number.
spk05: It's, you know, I presume that you're fired 10Q soon, so.
spk02: Corrected. 422 million shares, roughly.
spk05: Okay. Thank you so much, Rob.
spk02: Thank you, Oliver.
spk01: Our next question comes from Sefer Mansashiri with Eight Capital. Please proceed.
spk08: Good morning, and thank you for taking my question. My first question is about the substance use program. I just want to understand, as you're describing this KOL event, I'm sure we'll gain more insight. But is the positioning of the gaps that you're looking at in the current offerings, or when you talk about this KOL event and the highlighting of the gaps, is it more around the problem of substance use? Just want to understand if there'll be a comparison of the existing drug offerings, for example, or if this is more of an event around the problem at hand. like the opioid epidemic?
spk02: I see.
spk10: So it's important to, it's a bit of both, I would say, in the sense that the overall landscape is certainly critically important for us to understand, given the terrible tragedy of the opioid epidemic here in this country in particular. We just had recent data showing that in the last year, there were over 100,000 believed cases from opioid overdose deaths That is really a striking number and incredible growth over the last several years. And so highlighting that backdrop is a starting point, but also it's critical to understand where in the treatment landscape we're seeing significant challenges and where there's a gap that is resulting in this disorder being under cared for and underserved. And with that, we believe that it is in the early phase of patient-seeking treatment. in the treatment of opioid withdrawal and the facilitation of getting those patients onto medication-assisted therapy, such as buprenorphine or naltrexone. And that is why we're so excited about our approach in treating opioid withdrawal as a starting point with the MM110 program. So it will be highlighting both the backdrop but also the important gaps in the treatment landscape and why we believe and how we're approaching to fill that gap with our NM-110 program.
spk08: Got it. And I guess going off of that, do you see the fact that you have a broader psychiatry pipeline and this asset in the substance use program, are these all parts of different divisions or do you see this as something that is more separate on its own that could be poised for partnering out given that it's basically a separate program?
spk10: Certainly as we look at any of our disease area targets or any of our programs, we're always interested in having dialogue with various potential partners just to explore what opportunities there are and will continue to become available. Our goal and our vision in terms of what we believe the psychedelic drug class and other novel targets can do is to treat beyond just psychiatry but to treat the broader class of brain health disorders, which includes psychiatric indications, use disorders, pain, neurology. We believe that we are well poised to deliver on that full potential of this drug class and that we would continue assessing and approaching development opportunities outside of simply psychiatry. With that said, certainly as we progress and look towards getting deeper into clinical research programs and closer to hopeful commercialization of these products, there's always an opportunity with any individual program or disease area for selected partners to approach that would be more focused on a particular molecular indication. So we keep all of those options open to ourselves and certainly view the entire… And is there a governmental component there?
spk08: I know like the NIDA does some work. That's what I was trying to figure out with this KOL event and the fact that there is at least historical involvement from the government and the NIDA in terms of the substance use programs? Do you see potential for funding maybe off the back of this as a non-dilutive source of funding for this program?
spk10: Again, we're definitely always looking at non-dilutive sources of capital and ways to expedite and maximize the impact and the visibility of any of our programs. So it's important to highlight that, for instance, the MM110 program is not a psychedelic. It is not a controlled substance at this time, nor do we anticipate it will be. So it certainly has a bit of a broader and less encumbered ability to generate government-funded or non-diluted sources of capital, for example.
spk08: Certainly. And maybe just quickly touching on the GAD program, as obviously you've got encouraging data available on anxiety, I just want to understand the different... I understand you'll be using a different scale. Can you kind of touch on that and, I guess, the confidence you gained from the STI data? And I believe you're using HAM-A. Correct, yeah. And with the HAM-A, I guess, encouraging already, you guys, I believe, had that data as well.
spk10: So we had a Hamilton depression scale that was included in the... UHB study that we just read out. The strategy that they use as the primary outcome measure and the Hamilton Anxiety Scale, the most important point to highlight there, these are well-established outcome measures that have been used extensively. We know a lot about both of them. We know about how they intersect and correlate. We have a high degree of confidence that they are directly correlated and they're directly translatable in terms of our read-through and our view of de-risking the program and the clinical approach in GAD. So while they are different measures, I think if you look at the depression landscape, if you were to look at the number of scales that are available in depression scales, in the Madras, for instance, where we see a high degree of correlation, I think it's really important to note, too, that when we look at depression, anxiety, and the large degree of symptomatic overlaps and sort of construct overlap, both of the disorders and the outcome measures that are used to assess those disorders. It's important to see consistency, and so we're doubly encouraged by seeing a response in the STI-G and also in the Hamilton Depression Scale. So we think that these learnings are really important both for our GAD approach, but also as we think about the potential utility of LSD in treating broader class of psychiatric disorders over longer term.
spk08: I understand. And just the last one for me, do you anticipate providing maybe an update on maybe 50% enrollment point? I know first patient enrolled is typically something considered substantive or material, but in this market with CRO delays, I think the pace of enrollment itself is something that's been lacking visibility from a lot of companies, which is Is that something you guys have considered or an alternate form of update on maybe the cadence of enrollment?
spk10: Yeah, we haven't guided that we will be doing so, but certainly opportunities to provide update and clarity on progress of the study and where we are in the progress of enrollment is important information and something that we'll keep a close eye on and make decisions as we progress in the study. I certainly would share any of that publicly as soon as we were to make such a decision.
spk02: Okay. Okay. Thank you. Thank you for taking my questions.
spk01: Our next question comes from Tanya Armstrong-Whitworth with Canaccord Genusy. Please proceed.
spk06: Good morning, guys. Just a couple questions for me. Firstly, on the Phase 2B anxiety trial, are you able to see what the follow-up period will be? Like how long will you be monitoring these patients for after you dose them?
spk10: Yeah, good morning, Tanya. So the study's designed to follow patients after single administration for 12 weeks with a primary endpoint measure at four weeks after treatment.
spk06: Okay, so no data after 12 weeks. That's the definitive cutoff.
spk10: In this study, that's correct.
spk06: Okay. And then with respect to Project Angie, Are you going to be disclosing the chronic health indication that you're looking at prior to the commencement of that trial in Q4? And maybe just give us a timeline. Yes, absolutely.
spk10: Absolutely. So we anticipate starting that study in Q4. We don't have a definitive release date when we would be announcing the clinical design, but certainly as we approach it prior to initiation of that study, we provide additional clarity and would like to highlight the historical data and the approach for why we're pursuing that. So there will be certainly more to share about that program and the approach with medication and the clinical approach and development program. So we're very excited to share more of that. It would likely be closer to the initiation of that study in the third or fourth quarter.
spk06: Okay. And then lastly, thinking about, I guess, cost or investment allocation across your programs, could you give us an idea of how much we should be thinking about allocating towards the digital health versus drug programs?
spk02: In terms of spend or in terms of market potential?
spk00: In terms of spend.
spk10: Yeah, certainly the vast majority of our costs are directed towards our drug development programs. The digital programs are very important to highlight that where we see enormous opportunity and value is that if we can use those digital programs to facilitate further adoption of our drug therapies, that incremental market access and revenue growth in the long term would be a meaningful revenue and profit benefit to the organization. While we do continue the digital programs and see enormous value, they do represent a small fraction of the costs that are being outlaid in our R&D program.
spk06: Do you have a budget for the next couple of years on how much you want to allocate to those programs, or is that not something you disclosed?
spk10: We certainly do have a close budget. We manage very tightly, but it's something that we have disclosed in great detail in terms of the allocation across those programs. In some ways, it will be also driven by the incremental successes as we continue to advance. So I wouldn't want to give too much further guidance on the exact amounts of allocation, given that we have several important milestones and readouts over the next 12 months.
spk11: Okay, that's fine. That's it for me. Thanks, Rob. Thanks so much, Tyler.
spk01: This concludes the question and answer portion of the call. I would now turn the call back over to MindMed CEO, Rob Babel, for closing remarks. Rob?
spk10: All right. Thank you so much, and thank you, everyone, again, for joining us this morning. Before we conclude, I'd also like to thank the entire MindMed team, our investors, and many people who have been supportive to us along the way, including our study participants and their families. The time is now. It's never been more important to deliver on the potential that we have in front of us to overhaul the treatment of brain health disorders, and we all remain deeply committed to making that potential a reality. I want to thank you again and look forward to providing further updates on our exciting program as we progress throughout the year. Thank you, everyone.
spk01: This concludes today's teleconference and webcast. You may disconnect your lines at this time, and thank you for your participation. Have a great day.
Disclaimer