Good afternoon, and welcome to the Mind Medicine third quarter 2023 financial results and corporate update conference call. Currently, all participants are in listen-only mode. This call is being webcast live on the Investors and Media section of MindMed's website at mindmed.co, and a recording will be available after the call. After the presentation, there'll be an opportunity to ask questions. To join the question queue, you may press Star, then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing Star and zero. For opening remarks, I would like to introduce Rob Barrow, CEO of MindMed. Please go ahead.
Thank you, and good afternoon, everyone. Welcome to our third quarter 2023 financial results and corporate update conference call. The press release reporting our financial results is available in the Investors and Media section of our website, and our quarterly report on Form 10-Q for the quarter ended September 30, 2023, will be filed today with the Securities and Exchange Commission. 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, such as changes in market conditions and difficulties associated with research and development, regulatory approval processes that are described in the filings made with the SEC, including the most recent annual report on Form 10-K and quarterly report on Form 10-Q. Forward-looking statements are based on the assumptions, opinions and estimates of management at the date the statements are made, including the non-occurrence of the risks and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of MindMed's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, November 2, 2023. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law.
Joining me on today's call are Schond Greenway, our Chief Financial Officer, Dr. Daniel Karlin, our Chief Medical Officer, and Dr. Francois Lilienthal, our Chief Commercial Officer. We're excited to be providing this financial and business update during this important period for MindMed. Over the past year, we have made significant progress on our diversified R&D pipeline, which has positioned us for a series of important milestones in the coming quarters. In particular, the top line data readout from our phase 2B trial of MM-120 in generalized anxiety disorder or GAD. We believe our team continues to demonstrate best-in-class execution and with a cash runway that funds our organization into 2026, if certain milestones are achieved that unlock additional capital. We feel that we are well positioned to continue accelerating across our R&D pipeline.
Our progress comes at a critical time, with an urgent need for better treatments to address the ongoing epidemic of brain health disorders, a situation that has grown significantly worse over the past several years. In our lead indication, GAD, for example, a recent mental health prevalence study that was prepared for the Substance Abuse and Mental Health Services Administration, found that 10% of U.S. adults report having symptoms consistent with a GAD diagnosis, making it the second most common mental health disorder among adults aged 18 to 65 years old. In comparison to historical studies on the prevalence of GAD, this condition appears to have tripled in the last two decades alone, with an estimated prevalence of about 10% today.
This growth in prevalence and focus on anxiety disorders has unfortunately not been matched by innovative treatments, with the treatment landscape continuing to be dominated by serotonin reuptake inhibitors, benzodiazepines, and in more limited cases, antipsychotics. In fact, the last approved original marketing application for the treatment of GAD was obtained for Cymbalta in 2004. Seeking to address these growing issues, our R&D pipeline is focused on two lead candidates, MM-120 or lysergide tartrate and MM-402 or R-MDMA. Additionally, through a broad collaboration with researchers at University Hospital Basel in Switzerland, we are exploring the potential of several assets to potentially expand our development pipeline as our lead programs continue to progress.
Across these development programs, we are utilizing both a session-based delivery paradigm, such as with MM-120 in GAD, in which the product candidate is administered under ongoing healthcare supervision, and the standard outpatient drug delivery paradigm, such as with MM-120, as we explore recurrent non-hallucinogenic administration models and with MM-402 in autism spectrum disorder, which we envision being administered on a daily at-home basis. Our MM-120 program in GAD has seen extraordinary enthusiasm and execution over the past year. In August 2022, we dosed the first patient in our phase 2B dose optimization study of MM-120 for GAD. We completed enrollment in the study in just over one year and are now on the cusp of reporting top line data through four weeks of follow-up later this quarter.
GAD is a common debilitating brain health disorder that is underserved by currently available therapies. These therapies include serotonin reuptake inhibitors, benzodiazepines, and in more limited cases, buspirone and antipsychotics, all of which present inadequate efficacy profiles in many patients and often involve side effects that are intolerable and dose or duration limiting. Against this backdrop, we seek to develop MM-120 in a best-in-class therapy with a novel mechanism of action, in which an acute or single administration leads to weeks or even months of clinical benefit. In addition to the session-based delivery of MM-120 and GAD, we are investigating the direct neuropharmacological activity of MM-120 as a serotonin agonist in an innovative treatment regimen. One such exploratory approach is our phase 2 proof of concept study of MM-120 in ADHD.
This study is being conducted in collaboration with University Hospital Basel in Switzerland and Maastricht University in the Netherlands, and was designed to evaluate the therapeutic utility of repeat low doses of MM-120 in adult patients with ADHD. To date, no SAEs have been reported, suggesting the real-world potential of this treatment regimen, as well as demonstrating our ability to deliver MM-120 with innovative dose and frequency combination. As we announced in October, enrollment in this proof of concept study is complete, with a total of 53 participants administered either 20 micrograms of MM-120 or placebo twice weekly for up to six weeks. The primary endpoint in the study is the mean change from baseline in ADHD symptoms, as assessed by the Adult ADHD Investigator Symptom Rating Scale, or AISRS, after six weeks of administration.
We anticipate reporting top-line results from this study by the end of the first quarter of 2024. Our second lead program is MM-402, which is the R enantiomer of MDMA. We believe MM-402 holds promise for its potential prosocial effects and favorable tolerability profile versus racemic MDMA. The focus of our MM-402 program is to develop a regularly administered product that treats the core symptoms of autism spectrum disorder, or ASD, in particular, social communication difficulties. Remarkably, despite the significant and increasing prevalence of ASD, there are currently no approved therapies specifically targeted at its core symptoms. MDMA, often referred to as an empathogen, is a synthetic molecule known to enhance feelings of connectedness and compassion. The R enantiomer of MDMA, in particular, is believed to boost serotonin and other neurotransmitter levels in the brain, leading to increased sociability and interpersonal emotional connection.
Preclinical studies of R-MDMA, including those we reported earlier this year, have shown acute prosocial and empathogenic effects, while its reduced dopaminergic activity suggests it might exhibit fewer stimulant, neurotoxic, hyperthermic, and abuse-related effects compared to racemic MDMA or the S enantiomer. With robust preclinical evidence supporting our approach, we are excited to launch the phase 1 clinical trial of MM-402, which we expect to initiate later this quarter. The trial aims to assess MM-402's tolerability, pharmacokinetics, and pharmacodynamics, and we are actively exploring all possibilities to generate early indications of efficacy during development. Concurrently, we are collaborating with University Hospital Basel to conduct a comparative phase 1 pharmacokinetic and pharmacodynamic study of R, S, and racemic MDMA. This study was designed to enroll healthy volunteers and to evaluate the tolerability, pharmacokinetics, and acute subjective, physiological, and endocrine effects in the three molecules.
Successful completion of this study is expected to expedite our understanding of MM-402's pharmacological profile as we progress in the later stages of clinical development. We've been informed by the UHB investigators that they anticipate completing enrollment of the study by the fourth quarter of this year and anticipate that data will be presented in the first half of 2024. With the upcoming readout for our phase 2B study of MM-120 and GAD, we'll now take a moment to dive deeper into the context and approach to this important program. Lysergide, or LSD, is the most extensively studied drug in the psychedelic drug class, with over 10,000 individuals administered the molecule in clinical trials alone.
This includes hundreds of patients suffering from anxiety, depression, and other neurotic disorders across dozens of studies, which has consistently shown the potential of lysergide to deliver rapid and durable benefits with a magnitude of clinical activity that is double or triple that of the standard of care. Our phase 2B study of MM-120 and GAD was designed to characterize dose-response relationship of MM-120 and GAD across a wide range of doses. Our approach utilized an industry-standard study design with entry criteria and clinical endpoints that we believe are replicable in pivotal studies. As announced in September, we completed enrollment and dosing in our phase 2B trial, with top-line results to be reported later this quarter.
A total of 198 patients were randomized and administered a single dose of either 25, 50, 100, or 200 micrograms of MM-120 or a placebo and followed for up to 12 weeks. The primary objective of this study is to determine the dose-response relationship of MM-120 across the 4 active dose arms, as measured by the change in Hamilton Anxiety Rating Scale, or HAM-A, at 4 weeks post-dosing. This is the first large modern study to test the standalone pharmacological effects of a psychedelic drug candidate. That is, in the absence of any psychotherapeutic intervention, the importance of which was emphasized in the FDA draft guidance on clinical trials with psychedelic drugs earlier this summer.
We believe that it will also help provide key insights to inform an optimal phase 3 program, the design of which we anticipate discussing with the FDA in an end-of-phase 2 meeting after the conclusion of our phase 2B study. We believe the design and conduct of our phase 2B study is perhaps the most closely aligned with the FDA guidance that has ever been conducted, and as such, we are well positioned to seamlessly transition into pivotal studies of MM-120 and GAD, subject to positive results from our phase 2B study later this quarter. From a statistical standpoint, our phase 2B study utilized an approach called the Multiple Comparison Procedure Modeling, or MCPMod approach, a sophisticated statistical technique developed by Novartis in 2004, which we believe is especially well equipped to demonstrate dose response and optimize dose selection.
The MCPMod analysis involves a two-part statistical test, which first assesses whether any dose response exists, then assesses which of the pre-specified dose response curves, as illustrated on the right, most closely fits the data. This statistical methodology has received qualification opinions from both FDA and EMA, with both agencies commenting on the statistical efficiency and effectiveness of the approach due to the utilization of all available data that is captured across the study arms and informs the statistical conclusion. As we approach top line data for MM-120 and GAD later this quarter, it is important to contextualize the current treatment landscape and associated magnitudes of clinical response. The current standard of care for GAD is dominated by serotonin reuptake inhibitors and benzodiazepine, which account for approximately 80% of the market by dollar value here in the U.S.
Even so, results from peer review publications highlight the relatively modest clinical response to currently available therapies, as exemplified by a standardized effect size of under 0.4 for the leading GAD therapies. As a reminder, the standardized effect size can be conceptualized as a mean placebo-adjusted change divided by the standard deviation of that change, and is a useful measure of overall treatment effect between studies. A commonly cited review of GAD treatments that analyzed clinical data from 21 double-blind, placebo-controlled studies, found an average effect size of 0.36 for SRIs, 0.38 for benzodiazepines, with only 0.17 for buspirone.
These results and other published literature suggest that an effect size of 0.36 or better is viewed by the medical community as a clinically meaningful outcome, which is consistent with the feedback we have received from numerous key opinion leaders and practitioners in psychiatry. In addition to our conviction that MM-120 may represent a best-in-class therapy for the treatment of GAD, we believe that we will be able to achieve a scalable, widely adoptable treatment model with attractive delivery dynamics in comparison to recent innovative products in psychiatry, such as Janssen's Spravato or intranasal esketamine, which is currently approved to treat treatment-resistant depression. Each Spravato administration session requires 2 hours of monitoring, and Spravato is indicated for administration twice weekly during a 4-week induction phase, for a total of up to 8 treatment sessions or 16 hours of monitoring in the first month alone.
For patients that are fully compliant for a year of treatment with Spravato, they would be getting between 34 and 56 treatment sessions for a total of up to 102 hours of time in the clinic per year. Despite what seems like a significant physical and provider infrastructure required to deliver Spravato, there are now over 3,000 Spravato treatment centers nationwide, and both the cost of Spravato and provider time for patient monitoring are being covered by major insurers. While we believe the profile of MM-120 could open up its scalability even further, the recent success in the adoption of Spravato presents a promising proof case for the widespread adoption of MM-120. Through the first 9 months of the year, Janssen reported Spravato sales of approximately $483 million, up 89% compared to the same period in the prior year.
We continue to make significant progress in both our R&D programs and in advancing our commercial strategy and market readiness, and are excited to share more updates on both fronts in the months ahead. With that, I will turn the call over to our CFO, Schond Greenway, to discuss our financial results. Sean?
Thanks, Rob, and thank you all for joining us today. We will now turn to the company's financial results for the quarter ended September 30, 2023. As of September 30, 2023, MindMed had cash and cash equivalents totaling $117.7 million, compared to $142.1 million as of December 31, 2022. The company believes its available cash and cash equivalents, as well as its committed credit facility, are expected to fund operations into 2026 if certain milestones are achieved that unlock additional capital. For the 9-month period ended September 30, 2023, the company's net cash used in operating activities was $43.8 million, compared to $37.3 million for the same period in 2022.
Research and development expenses were $13.2 million for the quarter ended September 30, 2023, compared to $7.8 million for the same period in 2022, an increase of $5.4 million. The increase was primarily due to increases of $6.4 million in expenses related to clinical research and product development for the MM-120 GAD study, and $0.4 million in internal personnel costs as a result of increasing research and development capabilities, which were partially offset by a decrease of $0.4 million in expenses related to our MM-402 program, a decrease of $0.2 million related to our MM-110 program, a decrease of $0.5 million in preclinical activities, and $0.2 million in connection with various external R&D collaborations.
General administrative expenses were $8.4 million for the quarter ended September 30, 2023, compared to $9.2 million in the same period for 2022, a decrease of $0.8 million. Decrease was primarily related to issuance costs related to the Company's 2022 U.S. dollar financing warrants that were issued as part of the Company's public equity offering, which closed on September 30, 2022. I will now turn the call back to Rob, who will provide some closing comments.
Thank you, Schond. This is a very exciting time for MindMed, in which we are rapidly approaching significant milestones for our organization. These milestones include our four-week primary endpoint top-line data in our phase 2B trial of MM-120 in GAD, which is expected in the fourth quarter of this year, with twelve-week data expected by the end of the first quarter of 2024. We also anticipate presenting full data from the study at a scientific meeting in 2024. We also anticipate reporting proof of concept results for MM-120 in ADHD, with top-line data expected by the end of the first quarter of 2024.
For our MM-402 program, we are on the cusp of initiating our phase 1 trial later this quarter and anticipate sharing top-line data from the UHB investigator-initiated study of R, S, and racemic MDMA in the first half of 2024. As we come to a close, I want to extend my sincere appreciation and gratitude for the critical work and unmatched execution that has brought MindMed ever closer to realizing our mission. I'd like to thank our highly talented and deeply committed team, our research collaborators and clinical investigator teams, our investors, and the many other individuals who have been supportive, including especially our patients and their families. We are working tirelessly to deliver on the therapeutic potential of our pipeline and transforming the treatment landscape for many individuals living with brain health disorders.
With that, I'd like to thank you all again for joining us today, and I'm happy to take any questions.
Thank you. We will now begin the question-and-answer session. To join the question queue, you may press Star, then one on your telephone keypad. You will hear a tone acknowledging your request. If you are using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press Star then two. We will pause for a moment as callers join the queue. Our first question comes from Brian Abrahams of RBC Capital Markets. Please go ahead.
Hi, good afternoon, and thanks for taking my questions. Looking forward to seeing the data soon. Maybe just a bigger picture, overall market question and then a question on the upcoming data. Can you—you gave some of this information in the prepared remarks, and it was really helpful. I was wondering if you could elaborate a little bit more on the unmet need in generalized anxiety disorder. I guess, what's your understanding of, I guess, what do we know about the proportion of patients who fail SSRIs and then try, will go on to one of these next line agents?
How many of those would be considered treatment-resistant, and how are you thinking about that in the context of the overall market opportunity and I guess, the proportion of patients you think would be most likely, I guess, initially, to try a drug like MM-120?
Yeah. Thanks so much for the question, Brian. I'll respond briefly and just turn it over to Dr. Karlin to respond further. But at the high level, the concept of treatment-resistant anxiety or generalized anxiety disorder is less well agreed upon than it is for depression. So treatment-resistant depression is a label that has been given to other therapies and is a concept that has been more clearly articulated in various guidances and industry standards and standards of practice. That same construct has not been as directly applied to generalized anxiety disorder. What we do see is that a significant driver of value is the severity of the disorder. And as it happens, many of the patients, even those treated today, are moderate or severe and maintain moderate or severe symptoms over time.
I'll turn it over to Daniel Karlin to talk further about generalized anxiety generally, and perhaps we can dig into those specific numbers.
Yeah. Hey, hey, Brian, and thanks for that question. You know, it's a really interesting space for us to discuss because, of course, for the last 30 years or so, as Rob mentioned, the conversation around these disorders has been focused on major depressive disorder for a number of reasons that have less to do with the reality of people's experience with these illnesses and more to do with the marketing of SRIs. So that we know that there's a lot of undiagnosed GAD, which, you know, as Rob mentioned, we've seen this really, you know, multiple increase in both diagnosis of GAD and in the measured prevalence of GAD, which has now been estimated to be as high as 10%, among U.S. adults.
What we do know about the distribution of folks with GAD is that between 70%-80% of folks present with moderate to severe symptoms, and that, as many as 50% of people, fail their first, SRI, trial, and so either have inadequate response or have intolerable side effects.
... and that as many as 20% seem to fail multiple treatment attempts. So while there isn't a sort of community accepted definition of treatment-resistant GAD, we'd say it's going to land as somewhere between having failed one and two treatments. Now, is that exclusively the population that would try a drug like MM-120? I think the answer to that is probably no. So people end up on the best medicines we have, even if they have side effects that aren't entirely tolerable, but are more tolerable than the disease itself. And people accept inadequate treatment response when there aren't great options to move on to.
Of course, the hope is that if we have the sorts of effect sizes that have been suggested in prior academic work, and of course, the extraordinarily low rate of persistent adverse events, that this wouldn't necessarily just be a drug that exists in the domain of folks who, in the current state of psychiatry, have sort of been defined as treatment-resistant or whom drugs have failed.
Got it. That, that's really helpful context. And then just, you know, on the MCPMod analysis that they're doing on HAM-A, I guess, first off, can you talk about the sort of models that you're using to for the assumed dose-response? Are those six curves that you presented, are those the actual models, or if not, how are you kind of thinking about that? And then, you know, given that you're not doing pairwise comparisons specifically, what are the tools that you're going to use to hone in on and articulate an optimal dose, I guess, with respect to inputs on magnitude of activity and consistency across patients?
Yeah, great, great questions, Brian. Thanks so much. In terms of the curves, those are the illustrative curves that we are using. Of course, there are very precise measures against which those are established in the statistical analysis plan for the study. But generally, the shapes of those curves that we have presented are in line with the general kind of response models that we are testing against. It captures, we believe, a good number of potential dose response curves that very well could correspond to some of the healthy volunteer data we have and the pharmacodynamics of LSD from historical studies, and in our view, appropriately captures a variety of different responses at each of those dose levels.
In terms of the tools we will use, as one of the actual real benefits, both in terms of its statistical efficiency and using all of the available data to establish whether there is indeed a treatment effect or not. But there's also an added benefit here with the MCPMod that already established, baked into that analysis, because part of the statistical test is measuring against those nominated response curves. The selection of an optimal efficacy response and the slope of that response curve and the selection of an appropriate dose to move forward is already embedded in the analysis, using the MCPMod.
Coming out of the analysis, we will have a curve that we believe is the best fit to characterize the dose-response we have observed in the GAD population, and that will be one of the key aspects that informs the selection of dose to take forward in subsequent studies.
Really helpful. Thanks again.
Thanks, guys.
Our next question comes from Francois Brisebois of Oppenheimer. Please go ahead.
Hi, thanks for taking the questions. Can you just maybe discuss in terms of expectations for the GAD data, can you help us understand maybe the importance of the effect size, for kind of each dose? Or is this more a question of seeing, a dose relationship with maybe only, one of them getting an effect size of, you know, comparable to the, SSRIs that are out there? And then, you know, maybe on, on a second part of the answer, in terms of effect size, you know, it is compared to placebo here, and we've seen differences in different placebo responses in trials. I was just wondering if you had any comments about expectations around the placebo response. Thank you.
Yeah. Thanks so much, Frank. So in terms of your first question, with respect to the effect size, we'd potentially be observing in relation to that backdrop of currently available therapies for GAD. The model is such that we believe that if any of the doses being tested were to achieve a clinically relevant effect size or response, that it would be well captured, and that that would be enough to support the kind of conclusion. At our last earnings, we had reported that through simulation analysis, we have a high degree of confidence that if we do observe that clinically relevant response, that it would be likely to result in a statistical positive outcome using the MCPMod analysis.
So it is not pre-specified necessarily which exact one of these doses that we have tested would reach that maximum or optimal effect size or response, and that both adds a statistical efficiency to the methodology and also allows us with some flexibility for the interpretation, because we don't know definitively what the response curve is until we get to the conclusion of the study. It provides some flexibility, even if we see a response at a lower dose than we may be anticipating ahead of time. In terms of your second question about the placebo control, this is one that is critically important, and the field, of course, is still digesting the appropriate controls in the context of potential functional unblinding. FDA's guidance from June of this year highlights the importance of doing dose response studies-...
both to characterize the dose response in itself, but also because it is such a strong way to control for functional blinding. One of the important lines of inquiry we will certainly have as we reach the ultimate analysis and post hoc analyses of the study, would be to look at the comparisons both between the what we would perceive as the therapeutic or active dose levels, depending what we see in the data, and that versus the two control conditions we have. We have a control condition in the true placebo. We also have a control condition in a 25 microgram dose of MM-120, which is right at the threshold for any sort of psychotherapeutic, or excuse me, therapeutic activity or perceptual activity.
We'll also be able to look at the magnitude and the strength of blinding or the difference in terms of how patients respond between each of the dose levels to also aiding our assessment of functional blinding within the study. And, frankly, to also understand whether there is any incremental benefit in functional blinding at very low doses of MM-120, like 25 or even an intermediate dose, like 50 micrograms of MM-120. So we think there's an extraordinary level of insight we'll have from this study that is yet to be characterized by the field, and that will help us both in terms of designing future studies, but also in terms of informing the conversation with FDA and other health authorities about the appropriate controls in these studies and the right path forward.
That's great. Thank you very much.
Great.
Our next question comes from Jonathan Aschoff of Roth MKM. Please go ahead.
Thank you very much. I had a cash question. You burned about $17 million or $18 million in the third quarter. If you hold that absolutely flat over the next nine quarters, that barely gets you to 2025, and you say cashing into 2026. So if we call those two things the same, are we only going to burn as much cash as you burned in third quarter on average for nine quarters?
Yeah, thanks for the question, John. Certainly welcome Schond to respond as well. But generally, based on the status of our development programs, expenditures on a quarterly basis, of course, are driven in large part by our R&D expenditures. So as we progress and have further clarity, we can certainly offer additional insights in terms of expectations for various milestones. In terms of the cash available to us, including the credit facility we entered into earlier this quarter, yeah, as we noted-
Yeah, I've included that $35 million.
Additional capital. Right.
If you include that $35 million, it still requires you to not increase cash burn over the next 9 quarters. I mean, you know, like, yes or no, is that realistic? You know, average cash burn, that is.
Yeah, we...
Certainly believe... Yeah, go ahead, Schond.
We can certainly circle up offline, but as we said before, we haven't provided an actual quarter-over-quarter cash forecast, but we certainly will reiterate our current guidance into 2026.
Okay.
We can certainly take a note, take it offline as well.
No problem. Thank you, guys.
Our next question comes from Patrick Trucchio of H.C. Wainwright. Please go ahead.
Hi, everyone. Here's Luis on for Patrick. Thanks for taking our call or questions. On the pace of enrollment for 120 in GAD, can you tell us a little bit more about the level of enthusiasm of investigators, physicians, patients, and how this could impact the pace of enrollment and on the potential phase 3 program and possible launch?
Yeah, thanks so much, Luis. So, having been to many of the clinical sites and spoken with numerous investigators in our study, you know, I would say we have a high degree of confidence in our ability to continue executing with the kind of efficiency we have. We've seen extraordinary enthusiasm and engagement, both because of the conduct of the study and the interest in novel therapies for GAD, for thef product candidate we're developing. Also, we have to give credit to our team for the extraordinary engagement they have had with the clinical sites and their hands-on connectivity with the conduct of this study.
Couldn't ask for a better clinical team to run a development program, and like any study, it also always comes down to the ability to execute, and our team has shown over and over again the ability to do just that. In terms of enthusiasm, as we go into subsequent studies, we certainly believe we will continue to execute as we have historically. And having conducted this study and enrolled 198 patients in just over 1 calendar year, or just over 12 months, I should say, we feel like-
Mm-hmm.
We have proven that this can be done very efficiently and will continue to do so.
Thank you. That's helpful. And on the ADHD data readout that's coming soon, what would you need to see on that readout to have confidence to move forward? And moving forward, would it mean another phase II trial or right on to right into a phase III?
... Yeah, absolutely. For the ADHD study, and certainly as we get to that data availability, we'll be able to provide additional context. But in terms of expectations or what we need to see to move forward, certainly a clinically relevant and, I guess, statistically relevant, statistically significant response in that study would be obviously indicative of some activity that would be supportive of further investigation. In terms of what comes next, we haven't given specific thoughts on exactly what studies would come next, but certainly with the challenges of administering a drug that if overdose would have the kind of effect. And I say overdose in the context of administering more than the 20 micrograms twice a week that we had administered in that study.
Given some of the dynamic there, we certainly have to be in a position to look at alternate dosage forms or consider exactly how we'd approach that. That'd be part of a discussion with health authorities and exploration of what comes next for that program.
Schond, thank you.
Once again, if you have a question, please press Star, then One. Our next question comes from Michael Okunewitch of Maxim Group. Please go ahead.
Hi, this is Chad Owen from Michael. Thanks for taking the questions. So, I was wondering, how will the data generated from the phase 1 for MM-402 differ from the UHB study?
Yeah, it's a great question. In the UHB study, patients that were administered, excuse me, healthy volunteers were administered each of 4 different doses, 2 different dose levels of R-MDMA, a dose S-MDMA, and a dose of racemic MDMA. In our sponsored phase 1 study, we'll be doing a standard SAD/MAD kind of approach, where we'll be exploring the repeated administration as well as the single-dose administration. So while we're getting a preliminary characterization of the pharmacokinetics and pharmacodynamics effects of MM-402, or excuse me, R-MDMA, S-MDMA, and the racemic MDMA in the UHB study, the phase 1 study that we are conducting will give more granular definition and more of elucidation of what happens with repeated administration and characterization of how we might take that forward in a more standard dosing paradigm.
Okay, great. And then, how long will you continue to follow patients in the phase IIb for GAD? Will there be, like, an extended follow-up beyond the 12 weeks?
In the phase IIb study, we followed patients for 12 weeks. Given that we're doing full dose characterization in this study and we'd be selecting a dose, and as you've previously disclosed, we'll be transitioning to an oral design, a vital sort of key formulation as we progress in clinical development for MM-120. We anticipate that in subsequent studies, additional follow-up may be warranted, but in this study, we are only going to be following patients for 12 weeks.
Okay, great. That's all. Thanks for taking the questions.
This concludes the question and answer session. I would like to turn the conference back over to Rob Barrow for any closing remarks.
Thank you, operator, and thank you everyone again for joining us today. We look forward to sharing further results in the near future.
This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.