Q4 2024 Mind Medicine (MindMed) Inc Earnings Call
Speaker Change: Good morning and welcome to the Mind Medicine, 4th quarter and year-end 2024 Financial results corporate update conference call. Currently all participants are on the snowy
Speaker Change: 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. I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer of MindMed. Please go ahead.
Speaker Change: Thank you, operator, and good morning, everyone. Thank you for joining us for a discussion of MindMed's fourth quarter and year-end 2024 business highlights and financial results.
Speaker Change: Leading the call today will be Rob Barrow, our Chief Executive Officer, and he will be joined by Dr. Dan Karlin, our Chief Medical Officer. After our prepared remarks, we will open the call for Q&A.
Speaker Change: An auditor recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call.
Speaker Change: During today's call, we will be making certain forward-looking statements, including without limitations, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and our future expectations plans, partnerships, and prospects.
Speaker Change: These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development and regulatory approval processes.
Speaker Change: These and other risk factors are described in the findings made with the FEC and the applicable Canadian Securities Regulators, including our annual report on Form 10K by all today.
Speaker Change: Forward-looking statements are based on the assumptions, opinions and estimates of management.
At the date, the statements are made. [inaudible]
Speaker Change: including the non-occurrence of the risks and uncertainties that are described in the filing made with the FEC and the applicable Canadian Securities Regulators or other significant events occurring outside of MindMed's normal course of business.
Speaker Change: You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today March 6, 2025. MindMed disclains any obligation to update such statements, even if management sees change except as required by law. With that, let me turn the call over to Rob.
Thank you, Stephanie, to everyone for joining our call today.
Speaker Change: 2024 marked the year of unparalleled progress to MindMed, underscoring our leadership and advancing new treatments for brain health.
Speaker Change: We successfully achieved key milestones positioning us to deliver multiple clinical readouts from our MM-120 Phase 3 program in 2026.
Speaker Change: A year ago, we announced positive results from our phase 2D study at MM120 in Generalized Anxiety Disorder, or GAD, which showed statistically significant and durable improvements in mean Hamilton anxiety scale, or HMA, and clinical global impression severity, or CGIS scores, for 12 weeks after single dose of the MM120.
Speaker Change: We also announce the results of a pharmacokinetic bridging study of our orally dissolving tablet formulation of the M-120, our intended commercial formulation, which we are also using in our phase 3 studies.
Speaker Change: Auditionally in 2024, we secured a new formulation patent on Amendment 2020 ODT, extending our intellectual property protection through at least 2041.
Speaker Change: Based on the strength of our data and the seriousness of GAD, FTA grants in our MM120 GAD program breakthrough therapy designation, indicating its potential to represent a substantial improvement over currently available therapies.
Speaker Change: Our development approach prioritizes designing clean studies that yield clear results and are efficient
Speaker Change: This is exemplified by our bold decision early in development to study MM120 as a standalone treatment, and our streamlined Phase III clinical trial designs, which aimed to replicate the rapid, durable response observed in our Phase II B study.
Speaker Change: Our physical program in GAD includes two phase three studies, Boyage and Panorama.
Speaker Change: As we previously announced, we are very excited to have already successfully dose patients in both studies and we have seen strong enthusiasm from clinical sites and patients as recruitment has continued to ramp up.
Speaker Change: These sites include some of the highest performing enrollers from our phase 2b study, and we were very encouraged by early enrollment trends.
Speaker Change: We're also on track to those participants and emerge, our first phase three studies for the treatment of major repressive disorder or MDD in the first half of this year.
Speaker Change: This Phase 3 program closely aligns with our GAD program with a protocol that allows for a streamlined and efficient patient enrollment.
Speaker Change: These two indications, GAD and MDD, a factor approximately 51 million adults in the U.S. and represent two of the most significant unmet medical needs in psychiatry.
Speaker Change: We believe MM120 could offer a differentiated and compelling option in both GAD and MDD, potentially positioning it as a best-in-class and first-in-class treatment option.
Speaker Change: We aspire to deliver a truly transformative treatment that has the potential to change the trajectory of the ongoing brain health of the dynamic.
Speaker Change: In fact, in our research with providers, they have shared their beliefs that the availability of psychedelics will radically transform treatment for GAD and MDD.
Speaker Change: Over the past year, we have been dedicated to broadening the awareness and understanding of these disorders and sharing our findings in a number of key medical meetings, such as the American Psychiatric Association's Annual Meeting, the International Society for Health Economics and Outcomes Research Annual Meeting, and the American College of Neurocycle Pharmacology's Annual Meeting.
Speaker Change: We continue to generate evidence of underscores of significant economic and social burden of GAD in the United States, including a higher health care utilization and cost, as well as reduce work productivity.
Speaker Change: These findings highlight the substantial impact of GAD, which has largely been underappreciated.
Speaker Change: I couldn't be more thrilled with the progress we've made this past year.
Speaker Change: As we look forward, 2025 will be a year of execution, focus on our phase three programs in GAD and MDD, and preparing for our three Piffel Trial readouts in 2026.
Speaker Change: We have a strong dedicated team in place and continue to build a leading organization with the Best in Class Execution.
Speaker Change: Over the past year, we have also strengthened our financial position having raised approximately $250 million in gross proceeds and gained the support of a number of top institutional investors.
Speaker Change: We expect our current cash and cash equivalence to provide sufficient funding into 2027 with a cash runway that extends at least 12 months beyond the first phase three top line data readout for MM120 and GAD.
Speaker Change: Now, let me turn the call over to our Chief Medical Officer, Dr. Dan Karlin, to discuss our clinical development programs in more detail. Dan?
Thanks Rob.
Dan Karlin: As Rob just mentioned, we have already dose participants in both of our pivotal phase three clinical studies for GAD, voyage and panorama.
Dan Karlin: We are highly encouraged by the early enrollment trends and continue to expect top line readouts from Voyage in the first half of 2026 and Panorama in the second half of 2026.
Thanks.
each study consists of two parts.
Dan Karlin: Part A, a 12-week randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of MM-120 versus placebo.
Dan Karlin: and Part B, a 40-week extension period with opportunities for open label treatment, designed to provide important long-term data on the durability and response patterns with MM120.
In voyage, we expect to enroll approximately 200 participants.
Dan Karlin: who will be randomized one-to-one to receive the MM-120-100 micrograms or Cebo. While in Panorama, we expect to enroll approximately 250 participants who will be randomized two-to-one-to-two to receive the MM-120-100 micrograms, 50 micrograms or Cebo.
Dan Karlin: As Rob mentioned, we have taken an intentional and thoughtful approach to our development strategy.
Dan Karlin: which has been informed by our team's deep experience in developing novel Psychiatric Therapies and through Close Collaboration with FDA.
Dan Karlin: Our protocols are designed with operational input-proof sites and participants and specific attention to enabling enrollment so that we are able to rapidly recruit a representative sample of participants.
Dan Karlin: These trials incorporate important methods, such as the use of central raiders who are blinded to both treatment assignment and visit number.
Dan Karlin: Questionnaires to assess potential expectancy bias, and in the case of panorama multiple control arms, including a lower dose control that is perceivable and was previously tested.
Dan Karlin: This approach builds on our phase 2B data where we demonstrated that despite functional
Dan Karlin: At all tested doses, the lower doses, including 50 micrograms, did not demonstrate a meaningful
Dan Karlin: We believe this evidence strongly supports our view that the end-diolytic effect of MM120 cannot be attributable to functional blinding, and thus the measured effect reliably represents a true drug effect.
Dan Karlin: These trials were designed to have 90% power to detect a five-point improvement over placebo based on certain statistical assumptions. Where in the phase 2B trial, we observed an almost eight-point improvement for MM-120 over placebo at week 12th.
Dan Karlin: We are using an adaptive design in our phase three studies that includes the intern-blinded sample size re-estimation, which allows for increased enrollment of up to 50% in each trial.
Dan Karlin: This approach helps to adjust for any unexpected variability in nuisance parameters specifically drop out rates and pooled variants of AMA response, maintaining statistical power and enhancing the interpretability of our results if needed.
Dan Karlin: Key elements, such as inclusion and exclusion criteria, will largely mirror our successful phase to be study of MM120 and GAD, incorporating exclusion criteria around the recency or total use of psychedelics to ensure a representative sample is recruited.
Dan Karlin: We also conduct Comprehensive Safety Assessment and labs before and after the Administration of Amendment 120 and ensure the collection of all adverse events.
Dan Karlin: Turning to our MDD program with M1-20, we remain on track to dose our first participant in the first half of 2025 with data expected in the second half of 2026.
Dan Karlin: Just like in our GAD program, we anticipate that our MDD program will confess of two pivotal clinical studies.
Dan Karlin: Our first study, Emerge, will be comprised of two parts. Part A, a 12-week randomized double-blind placebo-controlled parallel group study is setting the efficacy and safety of a single dose
Dan Karlin: Piros, and part B of 40-week extension period during which participants will be eligible for open label treatment with MM120 subject to meeting eligibility requirements.
Dan Karlin: In a merge, we plan to enroll at least 140 participants with a primary diagnosis of MDD randomised one-to-one to receive MM120, 100 microgames for Fisebois.
Dan Karlin: The design and timing of a second MDD trial will be informed by the progress from emerged and additional regulatory discussions.
Dan Karlin: With that, I'll turn the call back over to Rob to discuss our fourth quarter and year-in financial results. Rob?
Rob Barrow: Thanks, Dan. During our finding to result for the year ended December 31, 2024, we ended the year with cash and cash equivalent, totaling $273.7 million, compared to $99.7 million as of December 31, 2023.
Rob Barrow: Overall, we believe that our cash and cash equivalent as of December 31st, 2024 will be sufficient to fund our operations into 2027 and at least 12 months beyond the top line data readout for our first day through trials and then 120 in GAD.
Rob Barrow: Research and Development Expenses were $21.8 million for the three months into December 31st, 2024, compared to $11.5 million for the three months into December 31st, 2023, an increase of $10.3 million.
Rob Barrow: R&D expenses were $65.3 million for the year in the December 31, 2024, compared to $52.1 million for the year in the December 31, 2023, an increase of $13.2 million.
Rob Barrow: The increase was primarily due to expenses related to our Pivotal MN120 programs, Phase 1 and MN402 program, and an increase of internal personnel costs, partially offset by a decrease in expenses related to preclinical activities.
Rob Barrow: We anticipate R&D expenses to ramp up in 2025 due to the cost associated with running three pivotal phase three studies.
Rob Barrow: General and Administrative expenses were $10.7 million for the three months in December 31, 2024, and were the same for the three months in December 31, 2023.
Rob Barrow: DNA expenses were $38.6 million through the year ended December 31, 2024, compared to $41.7 million for the year ended December 31, 2023, a decrease of $3.1 million.
Rob Barrow: The decrease was primarily integral to reduce professional services, fees, and expenses, partially and all sent by increased stock-based compensation expense and cost associated with pre-commercial
Rob Barrow: The companies that lost for the three months in the December 31, 2024 was $34.7 million, compared to $23.8 million for the same period in 2023, an increase of $10.9 million.
Rob Barrow: Company's net loss for the year in the December 31, 2024 was $108.6 million compared to $95.7 million for the same period in 2023, an increase of $12.9 million.
Rob Barrow: The increase was primarily attributed to research and development expenses associated with our MM120 and then for our two programs.
Rob Barrow: In closing, I'm incredibly proud of the progress we have made over the past year at MindMed.
Rob Barrow: We believe MM120 is uniquely positioned to potentially offer a novel and highly differentiated treatment option for people living with brain health disorders.
Rob Barrow: None of our progress would have been possible without the dedication of our exceptional team.
Rob Barrow: I want to thank them for their continued efforts in commitment to our mission.
Rob Barrow: With that, I'd like to thank you all again for joining us today, and the team and I are happy to take your questions.
Speaker Change: Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself in the queue, press star 1-1 again.
Speaker Change: Our first question comes from Mark Goodman with Learing. Your line is open.
Hi, this is Madu and the Lines for Mark.
Speaker Change: I think some people we speak with are trying to get a better understanding of which GAD patients would be likely to want to use MM120 over other available options once it could be eventually
Speaker Change: And so just curious, would this be for patients who strictly don't respond to other available therapies or patients past a certain severity level. If he could share any insights that you have on that maybe from market research or just in terms of the patients that are looking to enroll in these studies.
That would be great. Thank you.
Speaker Change: Yes, thanks so much, Mario, and I'll turn it over to Dan in a second, I think, at a very high level.
Speaker Change: I'm certainly the indication we're pursuing, which is the broad label for all generalizing exercises for the patients, wouldn't enable access.
Speaker Change: Much more broadly than if we had a severely restricted criteria on the label. So then there are pair dynamics that come into play and we've had really encouraging. [inaudible]
Speaker Change: Science in that research just based on the relative lack of treatments for GAD and the long time since any new treatments have been introduced and the overall severity of that population, but maybe Dan, if you want to add some clarity there as well.
Dan Karlin: Yeah, absolutely. And I think that there's a really interesting point there which is that
Dan Karlin: The sorts of patients who would be interested in accessing the drug is a really broad swath of the population.
Dan Karlin: You know, the four folks with diagnosed GD, tolerability and efficacy of existing drugs like SRIs is pretty unsatisfactory.
Dan Karlin: SRI's have never been particularly effective against anxiety cluster symptoms either in JAD or in DAD.
Dan Karlin: Step Therapy Requirements. So what you see often with new treatments in the class even new treatments that have a mechanism that's similar to existing treatments are the same as existing treatments.
Dan Karlin: is a requirement to have been failed by one or more existing treatments, but
Dan Karlin: You know, given the efficacy that we're seeing, given the appeal of having a single treatment with no lingering adverse events, we think that the demand side will be quite high.
Thank you.
Speaker Change: Thank you. Our next question comes from Gavin Clark Gardner with Evercore ISI. Your line is open.
Speaker Change: Hey guys, congrats on the progress and thanks for taking the questions.
Speaker Change: First, I just wanted to ask, are you planning to give more granular enrollment updates for both of the GAD trials over the course of this year, or is the next update that we should expect enrollment completion?
Speaker Change: Yeah, I think thanks so much, Gavin. We haven't yet provided the exact guys that we would expect to follow a similar.
Speaker Change: Pattern as industry standard, and as we did in our Phase II study, as we approached the end of enrollment, we were able to announce that, but certainly as we have any material updates, we would be disclosing notes.
Speaker Change: Got it, that makes sense. And separately, just on the sample size re-estimation analysis, I wanted to confirm that there's no alpha-use, no futility criteria, and also ask what you think the likelihood of the trial being upsized a little bit is, and when this analysis roughly may occur.
Yeah, great question.
Dr. J.
Speaker Change: The way the same size re-estimation of design is a no-alpha-spin blinded re-estimation, and the damage is only based on the nuisance parameters, the dropout rate, and the cold variance of
Speaker Change: of the senator, the covariance of him a outcome. So we can provide exact timing for when that would occur, other than upon the completion of about half the basis, about 100 pages, you make it through week 12, is when when we anticipate to run that analysis.
But certainly no futility, no...
Speaker Change: Spend of Alpha, and it's really just to ensure that power is maintained if any of those nuisance parameters are outside of our estimates. Now, the estimates we have, we feel quite confident and based on.
Long History of Historical Norms,
Speaker Change: this population and also analyzing the data from our phase two clinical trial. So we feel quite confident in the assumptions we've made at baseline, but it just adds an additional layer of protection in the event. There is some some kind of surprise on even the variance or on dropout rate.
Very helpful. Thank you. He's good.
Speaker Change: Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is open.
Speaker Change: Hi everyone, this is Nevin on for Brian . Thank you for taking our questions.
Speaker Change: So with the voyage in Penorama studies underway, I was wondering if you could provide any more color on what you're seeing in the early rates of enrollment or they're tracking.
Speaker Change: Inline with or better or worse than the prior Phase II trial and then I guess among those who just given that, you know, recent more enthusiasm for spectacular clinical trials in general.
Speaker Change: to change or potentially impact the expectancy bias among that group.
Speaker Change: Yeah, thanks so much, Dan. And so, we can't provide specific numbers in enrollment as damage. We've been really highly encouraged by the enthusiasm from providers, from patients, from the Early Enrollment Trends and...
Er... Er... Er...
Speaker Change: They're quite constant as a result, and the progress we're making in both of the studies.
Speaker Change: To your latter question, we wouldn't provide specific on demographics, but the inclusion exclusion criteria and the population we're pursuing are...
Speaker Change: Very, very close to the identical almost to the Phase II B trial and so certainly the expectation
Speaker Change: Screening that we do to ensure that we get the right patients from these studies, we feel quite confident that we're getting a similar population and representative one.
Speaker Change: Growing interest. I don't know that we could say that it had a direct impact in any measurable way on expectancy. I think...
Years or Decades.
People Enroll and Meet Stage Trials
Speaker Change: with a navigable expectancy regardless of the treatment that is being studied simply for the reason that most of his patients...
Speaker Change: Either unsatisfied or not getting the level of response from currently available therapies, and therefore come into clinical trials with hope that something new will potentially help them, and so while they may be randomized to get placebo or an inactive dose of drug
Speaker Change: We certainly expect, like with any kind of trial, there's going to be a degree of expectancy just by the nature of it being an
Speaker Change: Okay, thank you. And then a quick follow up as well. I know you had mentioned that the inclusion criteria were similar across.
Speaker Change: Both Panorama and Voyage. But looking at the Clint Riles listing for both of them and see that, the exclusion criteria for Voyage specifically mentioned by polar disorder but panorama does not. Is there any particular reason for that? No.
Thank you.
You know, the inclusion criteria consistent across...
across both studies in that respect.
Charles Duncan: Thank you. Our next question comes from Charles Duncan with Canter. Your line is open.
Charles Duncan: Hey, Morning Rob and Dan, congrats on the design and operationalizing these phase 3s. Thanks for taking the question.
I had another question about enrollment.
Speaker Change: Criteria. I think Dan mentioned that he expected, you know, a broad swath of patients to be interested in the study, but I guess I'm wondering, are you seeing any, you know, types of severity or
Speaker Change: Experience that are presenting, and then with regard to experience with LSD or psychedelics in the past, what is happening in terms of the enrollment for the patients in InfoHM panorama? Thanks.
Speaker Change: Thanks, Charles. I'll turn it over to Dan Dancer, but those.
Again, what we can't really comment on.
Rob Barrow: Leiden Romain in Phase 3, and what we were able to see in the Phase 2 study, again with, like what Rob said, nearly identical inclusion exclusion, was...
Rob Barrow: about two-thirds of patients with treatment experience who've been failed by prior treatments, about one-third who hadn't been treated.
Rob Barrow: 10-15% with a fairly recent diagnosis of GAD, you know, we know in the population that they're
Rob Barrow: There are almost twice as many people walking around with symptoms of moderate to severe g80, who have never been diagnosed with it on a population level.
Amin
Rob Barrow: M.A. of 30, just about 30, so that puts people well into the severe category and there's no reason to think that we were particularly different in this study.
Rob Barrow: So, you know, when we think about that, the breadth of the appeal of the treatment and the degree to which people aren't served by what's available, that's you know.
Rob Barrow: Again, while we can't comment exactly on phase three, there's no reason to think things would be looking all that different.
Speaker Change: Ok, and then let me ask you a quick, uh, for a little bit of nuance on panorama. I like that you're using a dose that doesn't appear effective.
to remove expectation bias but
for Unblinding. Excuse me.
Speaker Change: Were you surprised at how sharp the dose response curve was 50 versus 100 and do you anticipate that 50 really to have an unknown fact in and to remove or reduce the function on blind?
Speaker Change: Yeah, thanks so much, Charles. I think it's two key features there, and I'll talk on the additional response aspect first, which is a bit, um...
Speaker Change: Certainly, the design in the Phase 2 study, the primary analysis was one that is aimed at defining a dose response, where we pre-specified response curves and statistically showed that the data from the Phase 2 study matched multiple of those.
Speaker Change: Candidate, does response curve. So I said that the data certainly matched the...
Speaker Change: I think it was quite stark, as you mentioned, the fact that…
Speaker Change: In the primary and phase two at week four, there was less than a point improvement over placebo at the 50 microgram module and there was a seven and a half.
Speaker Change: 7.6 unit improvement over placebo for the 100 microgram dose. So, while we weren't surprised by the overall shape of the curve it is.
Speaker Change: and quite stark contrast that the difference in clinical response between 50 and 100 micrograms and the data that have been generated to Dayton has to recall really the only data in the field to look at A.
Speaker Change: A comprehensive dose response across a full range. Now, on the second point, it's really important to stress, and we think that the field in many instances has completed some of the issues that are at play with why we take these additional methodological steps.
Speaker Change: We talked before about potential expectancy, which we certainly expect to be the case in any clinical trial and with any treatment
Speaker Change: University of the Truth for Psychiatric Drugs, but for any treatment where there is a clear discernible acute effect, there's the risk that that functional activity
Could unblind the patients. And unbinding, importantly, is a binary variable. There's not a...
Speaker Change: A continuous degree, you can't be 20% unblinded or 80% unblinded, you're either blinded or not. And so what we saw in the face to data is that all patients across the dose levels effectively or unblinded, 88% or more,
Speaker Change: across all those levels were functioning. I'm blinded yet we saw that start, those response between the two levels and really the intent of including a 50 microgram dose. It's too really important that dose level is as close.
Speaker Change: to the acute perceptual effects as they clinically active or the dose of interest that we're studying 100 microns grams. Otherwise, it doesn't have similar functional activity and it doesn't
Speaker Change: The functional lining that we're pursuing. But really what we're trying to do fundamentally is sever the tie between
Speaker Change: An expectancy bias, and an impact on biasing with clinical outcomes.
Speaker Change: and we do that through many mechanisms, one of which is using line and centralized raiders, but by having that 50 microgram dose level, we're able to do it effectively.
Speaker Change: Through the consent process, inform patients that whether or not they feel effective at drawing a cute perceptual effect on the day of dosing, they may be receiving...
Speaker Change: that they feel something on the day of testing, they can't assume that they're getting a dose of drugs that's going to make them better, and really that's as great of a link as any study has ever been asked to go in psychiatry.
Speaker Change: to try to enhance the validity and minimize the bias of these outcomes.
Speaker Change: because like with other approved GAD therapies, like XANX for instance, there's a clear acute perceptual effect that I'm just hasn't looked at in the past and so we feel even stronger about the validity of the data that we'll be able to generate and be fed because of these additional analyses in the additional
to design out what's being included in the FACELY Program.
Speaker Change: So that we can kind of gauge how it's going over the course of the trial.
Speaker Change: and we will assume the pulled fan ideation of 10 units and a dropout rate of about 15%.
Okay, thanks. Very helpful.
Speaker Change: Thank you. Our next question comes from Francois Brisebois with Oppenheimer. Your line is open.
Speaker Change: Hi, this is Dan on for Frank, thanks for taking our question. Thanks for all the color around the enrollment as well as we think about the outcomes here. Just a quick one for us.
Speaker Change: Give it all this regulatory scrutiny in this space. It's the upcoming PTSD adcom. Is this something you're looking to learn from, to inform your own development? Or is this, you know, the indication for their point? So anything here?
Thanks.
All right, program.
Thank you.
Speaker Change: How much of a risk is there that some of those patients during the 12 randomized phase go on to take another therapy and then if that does happen that it might happen more so in the placebo patients than the treatment patients and then if that situation were to occur, how does that get handled by the stats plan. Thank you.
Speaker Change: Yes, thanks so much, Joel. We certainly have a high degree of confidence in our sites and go to great links to ensure that all patients adhere to.
Speaker Change: of the trial protocols, which includes, as a monitor therapy includes taking no other pharmacotherapies during the called week randomized period and really throughout the duration of the study. So, we monitor that very closely and for patients to...
Speaker Change: But we certainly mounted it very closely and tried to intrude here as to the protocol at every site and it had great success historically and in our engagement site so far.
Alright, thank you.
Speaker Change: Thank you. Our next question comes from Rudy Lee with Chardonn. Your line is open.
Rudy Lee: Hi, thanks for taking my question. I have a question regarding the MDD indication, given the competitive landscape for psychedelics, how important is MDD indication for MM120 to compete with other psychedelic products?
Rudy Lee: And when should we expect updates on the timing and the design of the second MDD study? Thank you.
Thank you very much.
Charles Duncan: Yeah, thanks so much, Rudy. You know, our overall, I think, focusing on the overall development plan for M120, we just see such a broad and massive market and opportunity to help.
and potentially millions of patients.
and having the broadest label.
Certainly enables us to-
Charles Duncan: Narotic Illness in Psychiatry, having a label that covers both GAD and MDD, effectively means that a patient coming in the door with either cluster of symptoms would be.
Charles Duncan: An on-label candidate for the product, and as we look around the landscape of any other therapies, focus.
Charles Duncan: Exclusively our primarily on treatment resistant depression. It's just a strategic difference in how we've approached.
Charles Duncan: The opportunity and what we think of in terms of the expansiveness of both the market and patient opportunity, how broad of an impact we can have and that's informed everything from the selection of GAD where there's been so few therapies in life.
Charles Duncan: 20 years and overall, there's far fewer treatments available for joint invite disorder than for MDD, but also in our plans to go after these two.
Charles Duncan: and really significant and large populations that in our view be able to set us apart and maximizing the patients we can help.
Dr. Johnson, Dr. Johnson.
Oh, very helpful.
Speaker Change: Thank you. Our next question comes from Sumant Kulkarni, with Can't Accord Genuity. Your line is open.
Sumant Kulkarni: Good morning, nice to see the progress and thanks for taking my questions. I have two. The first one is given you have breakthrough therapy designation for a member 120 that potentially allows for more back and forth with the FDA. Could you give us any details on when you had your last interaction with the agency and if any of the changes that are currently affecting government agencies are impacted your interactions in any way?
Speaker Change: Yeah, thanks so much, Sumant. As you mentioned, with Breakthrough Therapy Designation, we do have frequent interactions with the agency and very topics including clinical.
Speaker Change: Phase 3 program, but also a clerk for pharmacology and CMC and other aspects of the development program that are just as important to ensure the quality and the adequacy of our data to support submission, hopefully, and approval. We think very highly, look at FDA as strong partners with us.
Speaker Change: from the outset of our program, but especially as we've received the breakthrough therapy designation of the past year and brought on an incredible regulatory team who's...
Speaker Change: Just successfully interacted with the division extensively in the approval of Cobency.
Speaker Change: A career therapeutic student who we've been really encouraged by the level of engagement and the softfulness and the clarinus with which the division and the agency more broadly has.
Speaker Change: Engage with our program and feel a high degree of alignment and consistency in our approach with the expectations we're hearing. So we've been really encouraged and there's been a lot of coverage of the disruption in Washington and all that's happening there.
For sure, the stage are other interactions with
Speaker Change: Will the FDA have not been in change in any way and we've continued to, you know,
Thank you.
Speaker Change: Watching the Division of Psychiatry really go out of their way and go to great lengths to be constructive and highly engaged with us.
Speaker Change: Correct, thanks. And if we also, you know, if we fast-forward to a time when other psychedelic agents that involve shorter times in the clinic might become comparators at a time when MM120 is approved as well, what would the key point be in favor of MM120 versus a deuterated DMD, for example, with the knowledge that we haven't really seen phase two data on that molecule just yet.
Speaker Change: Look, with 50 million patients that we might be able to treat with bussy indications are going after, there are more than enough patients for many new treatment modalities but
Speaker Change: Some of the things we've been really encouraged by are both the magnitude and the durability, and in large and well-controlled, well-conducted studies where we are exceeding a robust placebo by more than double the standard of scare. It's not something we've seen broadly with the field. And there's also...
Speaker Change: Intermarker Research, and some site economics that play into this where.
Speaker Change: A treatment that requires a high degree of patient throughput can be problematic for these sites of care.
Speaker Change: We look at clinics at Deliver Sprovato and many of these clinics have to turn over the room four or five times a day, which they're being reimbursed on an hourly rate in many instances that becomes a huge administrative burden and quite inefficient economically for these sites. Okay, so.
Speaker Change: Well, I can get that face. There have been some assumptions made about the duration of various products. We have been at every turn really encouraged and
I.
Speaker Change: Highly convicted about our approach and what that will mean for us.
Sites of Care and Interpatient Access.
Thanks.
Speaker Change: And our next question comes from Patrick Trucchio with H.C. Wayne Wharton Company. Your line is open.
Patrick Truccio: Thanks. Good morning. A couple of follow-up questions from me. So, you know, clearly with the phase three trial and an anxiety, you know, primary endpoint is ham A. I'm just wondering which secondary endpoint?
Patrick Truccio: Things like function or quality of life could be important from both a regulatory as well as a pay or perspective.
Patrick Truccio: Secondly, I'm curious if you can discuss some of the H-O-R, you know, health economic outcome research that's been conducted and what further research that you plan to conduct in order to, you know, further support MM120 after it's, you know, potentially approved.
Patrick Truccio: and then, just lastly, I think, you know, the Phase II B trial, I think, should an eight-point improvement.
Patrick Truccio: on the Ham A, relative to placebo. I'm just curious how the learnings from that trial, you know, kind of led to the powering for the phase three studies.
Patrick Truccio: in GAD, but as well I'm wondering, you know, I know that data was collected on the on the madras and how the learnings from the phase 2B trial are influencing the phase 3 trial on MDD.
Thank you.
Yeah, thanks so much, Patrick. So, to your first question.
We're certainly looking at a number of visual secondary.
Patrick Truccio: Outcome Measures in the Phase 3 program. One that is of interest us is CGI, which is a overall disease severity and patient functioning score. And so that is one that we're quite interested in. At the time points we're interested in for the AMA to primary outcome measure.
Patrick Truccio: In terms of the A2R research, we've done extensive research several of the studies which we've now presented at Propostors and our dancing publications for. So that comes everything from, I think, when you look at GAD.
Patrick Truccio: There's been such a focus shift in the last 20 to 30 years away from anxiety, which for a long time was a predominant focus as I entered.
Patrick Truccio: There's been such a shift, two major representatives were there, we all remember the everyone worries.
Bye.
Patrick Truccio: Depression is a chemical imbalance in your brain, your commercials from the 1990s were the advent and introduction of SRIs that led to a pretty massive diagnostic drift and for tools for depression being rolled out pretty substantially. So over that time, the burden and the prevalence of GAD has grown substantially.
Patrick Truccio: and now affects that they mentioned when we look at. [inaudible]
Patrick Truccio: I've never been diagnosed and presumably just think that's how life is, it's how human experiences and so a lot of our work so far is focused on that prevalence and also on the impact on quality of life and on economic parameters like...
Patrick Truccio: Workplace Productivity, Absenteeism, Presenteeism, the overall economic burden on these patients and we have an incredible market access and HUR team that is continuing this work and that that allows us to
Patrick Truccio: Also, we try to make arguments for the value of a product and we really see that value come through overwhelmingly when we look at the magnitude of remission that we can achieve after a single administration that is durable for many months that the mass becomes really remarkably. [inaudible]
Patrick Truccio: Favorable in terms of the health economics for a treatment such as this.
Patrick Truccio: You know, and I think it's notable there that that was an improvement over about a 14 point placebo response.
which is...
Patrick Truccio: But about around 40% larger than the historical average in GADs, and let's SRI studies in a placebo Responsible about 10 units. Now, you know, we've assumed, as Dan mentioned, 90% power, power we studied at night should power based on a five point improvement over placebo.
Patrick Truccio: I think that's a fairly conservative assumption, especially when you consider that the phase two study included.
Bye.
Patrick Truccio: Arms, four of which were a dose of active drug and in the phase three studies we did during head-to-head rate.
Three Arms Study Wear,
Patrick Truccio: Based on a broad body of research into clinical trial effidologies we would expect that to potentially reduce the placebo response. So, we've been quite conservative, and we also have the sample size re-estimation to make sure we don't lose that power in the study conduct.
Patrick Truccio: But, you know, certainly feel quite confident in the strength of that powering and the probability of a successful study if we see a clinically meaningful response from Frisebois.
Speaker Change: Right. That's really helpful. And if I could just one additional question, just I'm wondering how you're measuring the long-term durability of MM120 and part B of the studies. And do you need that data in order to be able to submit for approval or, you know, could you submit with the, you know, I think the 12 week data would that be sufficient. Thank you.
Dr. Paret, Dr. Paret.
Speaker Change: Yeah, great, great question. I mean, you know, we're not in a position today to speak to and what would be acceptable for the application. But I certainly think we look back at historical precedence for depression and anxiety drugs.
Speaker Change: The outside of durability has been required for almost all products has been.
So the anxiety has been...
Speaker Change: between four and 12 weeks of activity, so that that's quite encouraging that we have such a long and an extensive precedent there.
Robert Barrow, Reid Robison, Daniel Karlin
in terms of characterizing the durability of response. We're looking at...
Speaker Change: beyond the 12 weeks of the 9-month extension period with the opportunity for open label treatment. So a few things there, one is that until a patient, and importantly, until a patient actually takes the open label product in that extension period, they're still blinded.
Speaker Change: They're not told at the end of 12 weeks what treatment assignment we don't.
all right
Speaker Change: at any point in the trial until everything is completely done, what we need to be unwinding on a patient basis. Now we can do, importantly, group level on blinding and in primary analysis once we get through 12 weeks because that has no impact on the study.
I don't know.
Speaker Change: But for patients who continue into the extension phase.
Speaker Change: Response Actory, Single Treatment at baseline, and Presumably, there will be a higher rate [inaudible]
Relapse or Inefficacy.
Speaker Change: Patients who never respond in the placebo arm and they're as likely that we would expect.
Speaker Change: An Open Label Treatment is administered for patients who receive M-121st before they versus placebo at first dose. And so we're looking at a number of characteristics there, both to quantify durability beyond 12 weeks after a single treatment and then the use patterns of the durability and subsequent response, if patients do administer an open label treatment in the following period.
Great. Thanks so much.
Speaker Change: Thank you. Our next question comes from Michael Okunewitch with Maxim Group. Your line is open.
Michael Okunowicz: Hey guys, thank you so much for taking my questions today and congrats on all the progress we've made.
Thank you.
I guess it's just-
Speaker Change: One quick question here on runway and capital use. You guys have done a fantastic job managing your balance sheet so far. You do have two phase threes on going and a third launching in major depression.
Speaker Change: And the conventional wisdom there would suggest you would need a confirmatory study in MDD as well. So, would you expect a confirmatory in MDD to be lost concurrently with your other programs? And is this something you consider in your current Broadway projections?
Speaker Change: Yeah, thanks so much, Michael. We certainly consider all of our development plans across all of our programs and our financial productions and guidance for cash and runway.
Speaker Change: You know, our approach in major press disorder is such that, as we said, we're not in position.
Speaker Change: to comment on the exact precise timing or design of the second.
Speaker Change: Study and MDD today, we have had constructive progress in our overall planning for our program and our assets and so they're excited to share that data at a future point in time and that will be informed by some of the progress in our ongoing phase three studies and regulatory interactions.
Thank you.
Speaker Change: Certainly one of the attributes in our execution of our program is the ability to contain it, continue sites and efficiently.
Speaker Change: You know, keep them going in terms of screening and enrollment. So, we're certainly mindful of the operational efficiencies of when we start studies, but also things I mentioned, the prudent and responsible of how managing our cash are expensive, the conduct of our FAQ program.
Speaker Change: All right, thank you very much and once again, congrats on all the progress.
Richard.
Speaker Change: Thank you. This concludes the question and answer session and you may now disconnect. Thank you for your participation. Everyone have a great day.