Mind Medicine (MindMed) Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 2, 2023

Key Takeaways

  • MindMed ended Q3 with $117.7 million in cash and cash equivalents plus a $35 million credit facility, providing runway into 2026 if key milestones are met.
  • Enrollment in the Phase 2b trial of MM-120 (lysergide tartrate) for generalized anxiety disorder is complete (198 patients), with 4-week HAMA top-line data due in Q4 2023 and 12-week follow-up by Q1 2024.
  • The Phase 2 proof-of-concept study of MM-120 in adults with ADHD (53 participants dosed) is fully enrolled, and topline results are expected by end of Q1 2024.
  • MindMed plans to launch Phase 1 PK/PD trials of MM-402 (the R-enantiomer of MDMA) later in Q4 2023 and anticipates presenting healthy-volunteer data in H1 2024.
  • R&D expenses rose to $13.2 million in Q3 2023 (up $5.4 million year-over-year), driven by clinical research for MM-120, and net cash used in operating activities was $43.8 million for the first nine months.
AI Generated. May Contain Errors.
Earnings Conference Call
Mind Medicine (MindMed) Q3 2023
00:00 / 00:00

There are 7 speakers on the call.

Operator

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 Med's website at mindmed.co, and a recording will be available after the call. After the presentation, there will be an opportunity to ask questions. For opening remarks, I would like to introduce Rob Barrow, CEO of MyMed.

Operator

Please go ahead.

Speaker 1

Thank you, and good afternoon, everyone. Welcome to our Q3 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 10Q 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 ks and Quarterly Report on Form 10 Q.

Speaker 1

Forward looking statements are based on the assumptions, opinions and estimates of management at the date 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 MyMed's normal course of business. You're cautioned not to place undue reliance on these forward looking statements, which are made as of today, November 2, 2023. MyoMed 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 Sean Greenway, our Chief Financial Officer Doctor. Daniel Carlin, our Chief Medical Officer and Doctor.

Speaker 1

Francois Lillemtau, our Chief Commercial Officer. We're excited to be providing this financial and business update during this important period for Mymet. Over the past year, have made significant progress on our diversified R and 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 MN-one hundred and twenty and 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 and D pipeline.

Speaker 1

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 the GAD diagnosis, making it the 2nd most common mental health disorder among adults aged 18 to 65 years old. In comparison to historical studies of the prevalence of GAD, this condition appears to have tripled in the last 2 decades alone with an estimated prevalence of about 10% today.

Speaker 1

This growth in prevalence and focus on anxiety disorders has unfortunately not been matched Innovative Treatment, with the treatment landscape continuing to be dominated by serotonin reuptake inhibitors, benzodiazepine 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 and D pipeline is focused on 2 lead candidates, MM120, a lysergi detar trait and MM402 or rmdMA. 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.

Speaker 1

Across these development programs, we are utilizing both a session based delivery paradigm, such as with the MM120 and GAD, in which the product candidate is administered under ongoing healthcare supervision and the standard outpatient drug delivery payer guidance, Such as with MN-one hundred and twenty as we explore recurrent non hallucinogenic administration models and with MN-four zero two in autism spectrum disorder, which we envision being administered on a daily at home basis. Our MM120 program in GAD extraordinary enthusiasm and execution over the past year. In August 2022, we dosed the first patient in our Phase 2b dose We completed enrollment in the study in just over 1 year and are now on the cusp These therapies include serotonin reuptake inhibitors, benzodiazepines, in more limited cases, buspirone and antipsychotics, all of which present inadequate efficacy profile to many patients and often involve side effects that are intolerable and dose or duration limiting. Against this backdrop, we seek to develop IMM120, a best in class therapy with a novel mechanism of action, in which in acute or single administration leads to weeks or even months of clinical benefit. In addition to the session based delivery of MN-one hundred and twenty and GAD, we're investigating the direct Neuropharmacological activity of IMM120 is serotonin agonist and innovative treatment regimen.

Speaker 1

One such exploratory approach This is our Phase 2 proof of concept study of NM120 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 MM120 in adult patients with ADHD. To date, no SAEs have been reported, We're testing the real world potential of this treatment regimen as well as demonstrating our ability to deliver NRM-one hundred and twenty 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 IMM120 or placebo twice weekly for up to 6 weeks. The primary endpoint in the study The mean change from baseline in ADHD symptoms as assessed by the Adult ADHD Investigator Symptom Rating Scale or AISRS after 6 weeks administration.

Speaker 1

We anticipate reporting top line results from this study by the end of the Q1 of 2024. Our 2nd lead program is MM402, which is the R enantiomer of MDMA. We believe MM402 holds promise for its potential prosocial effects and favorable tolerability profile versus racemic MDMA. The focus of our MM402 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.

Speaker 1

MDMA, often referred to as menpathogen, The synthetic molecule known to enhance feelings of connectedness and compassion. The RNA tumor 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 rmbma, including those we reported earlier this year, have shown acute prosocial and pathogenic effects, While its reduced dopaminergic activity suggests it might exhibit fewer stimulant, neurotoxic, hyperthermic and abuse related effects compared to racemic and DMA With robust preclinical evidence supporting our approach, we are excited to launch the Phase 1 clinical trial and move forward to, which we expect to initiate later this quarter. The trial aims to assess MM42's tolerability, pharmacokinetics and pharmacodynamics, We are actively exploring all possibilities to generate early indications of efficacy during development. And currently, we are collaborating with University Hospital Basel to conduct comparative Phase 1 pharmacokinetic and pharmacodynamic study of R, S.

Speaker 1

In racemic MDMA. This study was designed to enroll healthy volunteers and to evaluate the tolerability pharmacokinetics We anticipate completing enrollment of the study by the Q4 of this year and anticipate that data will be presented in the first half of twenty twenty four. With the upcoming readout for our Phase 2b study of MN120 in GAD, we'll now take a moment to dive deeper into the context and approach to this important program. Glycergyde or LSD is the most extensively studied drug in the psychedelic drug class with over 10,000 individuals administered the molecule This includes hundreds of patients suffering from anxiety, depression and other neurotic disorders across dozens of studies, which has consistently showed the potential of Lysergi to deliver rapid and durable benefits The magnitude of clinical activity, it is double or triple that of the standard of care. Our Phase 2b study of MN-one hundred and twenty and GAD was designed to characterize dose response relationship of MN-one hundred and twenty and GAD We believe are replicable and pivotal studies.

Speaker 1

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 M1120 or a placebo and followed for up to 12 weeks. The primary objective of this study is to determine the dose response relationship of MN-one hundred and twenty across the 4 active dose arms as measured by the change in Hamilton Anxiety Rating Scale or HAMA at 4 weeks post dosing. This is the 1st large modern study to test the standalone pharmacological effect 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 FDA and an end of Phase 2 meeting after the conclusion of our Phase 2b study.

Speaker 1

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 MN-one hundred and twenty and GAD subject to positive results from our Phase 2b study rate From a statistical standpoint, our Phase 2b study utilized an approach called the multiple comparison procedure modeling or MCP mod 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 MCP mod analysis involves a 2 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 arm and informs the statistical conclusion. As we approach top line data for MM120 and GAD later this quarter, is important to contextualize the current treatment landscape and associated magnitudes of clinical response.

Speaker 1

The current standard of care for GAD is dominated by serotonin Even so, results from peer reviewed publications highlight these relatively modest clinical response to currently available therapies, 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 is a useful measure of overall treatment effect between studies. A commonly cited review of GAD treatment that analyze clinical data from 21 double blind placebo controlled studies found an average effect size of 0.36 for SRI, 0.38 for benzodiazepine 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 with 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 IMN-one hundred and twenty 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 SPRAVATO or Intranasal esketamine, which is currently approved to treat treatment resistant depression.

Speaker 1

Each And for patients that are fully compliant for a year of treatment with SPEAKER DOCTOR. They will be getting between 30 four 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 IMM120 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 ENDM120. Through the 1st 9 months of the year, Janssen reported SPRAVATO sales of approximately $483,000,000 up 89% compared to the same period in the prior year.

Speaker 1

We continue to make significant progress in both our R and D programs in advancing our commercial strategy and market readiness and are excited to share more updates on both fronts in the months ahead. With that, will turn the call over to our CFO, Sean 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.

Speaker 1

As of September 30, 2023, MyMed had cash and cash equivalents totaling $117,700,000 compared to $142,100,000 as of December 31, 2022. The company believes its available cash and cash equivalents as well as its committed credit facility 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 $43,800,000 compared to $37,300,000 for the same period in 2022. Research and development expenses were $13,200,000 for the quarter ended September 30, 2023, compared to $7,800,000 for the same period in 2022, an increase of $5,400,000 The increase was primarily due to increases of $6,400,000 in expenses related to clinical research and product development or at the MM120 GAD study and $400,000 in internal personnel costs as a result of increasing research and development capabilities, which were partially offset by a decrease of $400,000 in expenses related to our income four zero two program, A decrease of $200,000 related to our ALM-one hundred and ten program, a decrease of $500,000 in preclinical activities and $200,000 in connection with various external R and D collaborations. General and administrative expenses were $8,400,000 for the quarter ended September 30, 2023, compared to $9,200,000 in the same period for 20 Thank you.

Speaker 1

A decrease of $800,000 The decrease was primarily related to issuance costs related The company's 2022 U. S. Dollar financing warrants that were issued as part of the company's public equity offering was closed on September 30, 2022. I will now turn the call back to Rob, who will provide some closing comments. Thank you, Sean.

Speaker 1

This is a very exciting time for EyeMed in which we are rapidly approaching significant milestones for our organization. These milestones include our 4 week primary endpoint topline data in our Phase 2b trial of MN-one hundred and twenty and GAD, which is expected in the Q4 of this year, with 12 week data expected by the end of the Q1 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 MN-one hundred and twenty in ADHD with top line data expected by the end of the Q1 of 2024. For our MM402 program, we are on the cusp of initiating our Phase 1 trial later this quarter and anticipate sharing top line data from the UHB 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.

Speaker 1

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 of the landscape for many individuals living with brain health disorders. With that, I'd like to thank you all again for joining us today and happy to take any questions.

Operator

Thank you. We will now begin the question and answer session. Our first question comes from Brian Abrahams of RBC Capital Markets. Please go ahead.

Speaker 2

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 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?

Speaker 2

How many of those would be considered treatment resistance? 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 MM120?

Speaker 1

Yes. Thanks so much for the question, Brian. I'll respond briefly and then turn it over to Doctor. Carlin 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.

Speaker 1

So if you've ever resisted depression as a label that has been given to other therapies and the concept that has been We're clearly articulated in various guidances and industry standards and things of practice. That same construct is not As directly applied to generalized anxiety disorder, what we do see is that a significant driver Value is the severity of this disorder. And as it happens, many of the patients, even those treated today are moderate or severe I'll turn it over to Dan Carlin to talk further about generative value generally and congrats we can dig into those specific numbers.

Speaker 3

Yes. Hey, Brian, and thanks for that question. 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 aggressive 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 as Rob mentioned, we've seen this really 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 JV is that between 70% to 80% of folks present with moderate to severe symptoms And that as many as 50% of people fail their first SRI trial, So either have inadequate response or have intolerable side effects and that as many as 20% seem to fail Multiple treatment attempts.

Speaker 3

So while there isn't a sort of community accepted definition of treatment resistant GAD, We'd say it's going to land somewhere between I think I have 1 and 2 treatments. Now is that exclusively the population that would Try a drug like MM120, 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 Portland Drugs have sales.

Speaker 2

Got it. That's really helpful context. And then Just on the MCP mod analysis that you're doing on Hammeh, I guess first off, could you talk about The sort of models that you're using to for the assumed dose response, are those ticks curves that you presented? Are those the actual models? Or if not, how are you And then, 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.

Speaker 1

Yes. 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 But generally, the shapes of those curves that we had presented are in line with the general kind of response models that we are testing again.

Speaker 1

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 pharmacy dynamics of LSD from historical studies and in our view Perfectly captures a variety of different responses at each of those dose levels. In terms of the tools we'll use, it has one of the actual Benefits both in terms of its fiscal 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 MCP mod 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 MCP MOD. So coming out of the analysis, we will have a curve that we believe is the best that to characterize the dose response We have observed in the JV population that will be one of the key aspects that informs the selection of this to take forward in subsequent studies.

Speaker 2

Really helpful. Thanks again.

Speaker 1

Thanks guys.

Operator

Our next question comes from Francois Brabois of Oppenheimer. Please go ahead.

Speaker 4

All right. Thanks for taking the questions. Gus, in terms of expectations for the GAD data, can you help us understand maybe the importance of the effect size For each dose or is this more a question of seeing a dose relationship with maybe only One of them getting an effect size of comparable to the SSRIs that are out there. And Maybe on the second part of the answer, in terms of effect size, it is compared to placebo here and we've seen differences in different placebo responses and trials. I was just wondering if you had any comments about expectations around

Speaker 1

the placebo response. Thank you. Yes. Thanks so much, Frank. So in terms of your first question, with respect to the effect size, we're We'll potentially be observing in relation to that context, that backdrop of currently available therapies for GAD.

Speaker 1

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, It would be well captured and that would be enough to support the kind of conclusion that on our last earnings, we had reported that Simulation analysis, we have a high degree of confidence that if we do observe that clinically relevant response, it would be likely to result in a statistical positive outcome using the MCP Phemod 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 of the response and that both adds the statistical efficiency of the methodology It 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 unblind date.

Speaker 1

FDA's guidance from June 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 One of the important lines of inquiry we'll certainly have as we reach the ultimate analysis and product analysis of The study would be to look at the comparisons both between the what we would perceive as the therapeutic or active Dose levels, what we see in the data, and that versus the 2 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 MN-one hundred and twenty, 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 Winding within the study and frankly to also understand whether there is any incremental benefit in functional blinding At very low doses up in 120 like 25 or even an intermediate dose like 50 micrograms up in 120.

Speaker 1

So 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

Speaker 4

That's great. Thank you very much.

Operator

Our next question comes from Jonathan Aschoff of ROTH MKM. Please go ahead.

Speaker 3

Thank you very much. I had a cash question. You've earned about $17,000,000 or $18,000,000 in

Speaker 1

the 3rd quarter. If you

Speaker 3

hold that absolutely flat over the next 9 quarters, that barely gets you through 2025, and you say Cash into 2026. So if we call those two things the same, are you obviously only going to burn as much cash as you burned in 3 quarter on average for 9 quarters.

Speaker 1

Yes. Thanks for the question, John. And certainly welcome Sean 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 and D expenditures. And so as we Progress and have further clarity, we could certainly offer additional insights in terms of expectations for various milestones.

Speaker 1

In terms of the cash that's available to us, including the credit facility we entered into earlier this quarter, as we noted, we included that $35,000,000 additional

Speaker 3

And if you include that $35,000,000 it still requires you to not increase Cash burn over the next 9 quarters and I mean, yes or no, is that realistic, average cash burn? Yes,

Speaker 1

we certainly believe yes, go ahead, Sean. We can certainly I'm sorry, we can certainly circle up offline, but as we said before, we haven't provided an actual quarter over quarter Cash forecasts, but we certainly will reiterate our current Guidance into 2026. Okay. We can certainly take it offline as well.

Speaker 3

No problem. Thank you, guys.

Operator

Our next question comes from Patrick Trucchio of H. C. Wainwright. Please go ahead.

Speaker 5

Hi, everyone. Here is Luis on for Patrick. Thanks for taking our call our questions. On the pace of enrollment for 120 in GAD, can you tell us a little bit more about the level of The enthusiasm of investigators, physicians, patients and how this could impact the pace of enrollment And on the potential Phase 3 program and possible launch?

Speaker 1

Thanks so much, Lee. So having been to many of the clinical sites and spoken with Numerous investigators in our study, I would say we have a high degree of confidence in our ability to continue 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 the product candidate we're developing, also give credit to our team for the Extraordinary engagement they have had with clinical sites and their hands on connectivity with the conduct of this study. It could master a better clinical team to run a Development program and like any study, it always comes down to the ability to execute. Our team has shown over and over again, people in view just that. In terms of enthusiasm as we go into subsequent studies, we certainly believe we will continue to execute as we have historically.

Speaker 1

Having conducted this study and enrolled 198 patients in just over one calendar year or just over 12 months, I should say, We feel like we have proven that this can be done very efficiently and we'll continue to do so.

Speaker 5

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 2 trial or right on to right into a Phase 3?

Speaker 1

Yes, 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 think a 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 will come next, but certainly with the challenges of administering a drug that If overdose would have the kind of effect in assay overdose in the context of administering more than the 20 micrograms twice a week that we didn't And then sharing that study, given some of the dynamic there, we certainly have to be in a position to look at Ultimate dosage forms are considered exactly how we would approach that and that'd be part of the discussion with how we've got an exploration of what comes next to that program.

Operator

Our next question comes from Michael Okenwich of Maxim Group. Please go ahead.

Speaker 6

Hi. This is Chad on for Michael. Thanks for taking the questions. So I was wondering how will the data generated from the Phase 1 for NM402 differ from the UHB study?

Speaker 1

Yes, it's a great question. In the UHB study, patients Healthy volunteers were administered each of 4 different doses, In our sponsored Phase 1 study, we will be doing A standard SADMAD kind of approach where we'll be exploring the repeated administration as well as the single dose administration. So We're getting a preliminary characterization of the pharmacokinetics and part of the dihanics, vaccines, as I move forward to or excuse me, rMDMA, SMDMA and the same again DMA and the UHP study, the Phase 1 study that we are conducting will give more granular definition and more An elucidation of what happens with repeated administration, a characterization of how we might take that forward in a more standard dosing paradigm.

Speaker 6

Okay, great. And then, how long will you continue To follow patients in the Phase 2b for GAD, will there be like an extended follow-up beyond the 12 weeks?

Speaker 1

In the Phase 2b study, we followed patients 412 week, given that we're doing Full dose characterization in this study and then be selecting a dose and as we previously disclosed will be transitioning to an oral desonic Aditis ODT formulation as progression of clinical development for MM120, 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.

Operator

This concludes the question and answer session. I would like to turn the conference back over to Rob Barrow for any closing remarks.

Speaker 1

Thank you, operator, and thank you, everyone, again for joining us today. We look forward to sharing operator results

Operator

This concludes today's conference call. You may disconnect your lines. Thanks for participating and have a pleasant day.

Powered by Quartr