Q3 2024 Mind Medicine (MindMed) Inc Earnings Call
The
Dr. Prado, Dr. Prado.
Speaker Change: Good afternoon, and welcome to My Medicine, third quarter, 2024, Financial Results and Corporate Update Conference Call.
Speaker Change: 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.
Speaker Change: I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer at MindMed. Please go ahead.
Stephanie Fagan: Thank you, operator, and good afternoon, everyone. Thank you for joining us today for a discussion of MindMed's third quarter 2024 business highlights and financial results.
Stephanie Fagan: Leading the call today will be Rob Barrow, our Chief Executive Officer. He will be joined by Dr. Dan Karlin, our Chief Medical Officer, and Francois Leventhal, our Chief Commercial Officer.
Stephanie Fagan: After our prepared remarks, we will open the call for Q&A.
Stephanie Fagan: An audio recording and webcast replay for today's conference call will also be available online as details in the press release announcement for this call.
During today's call, we will be making certain forward-looking statements.
Stephanie Fagan: including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and future expectations, plans, partnerships, and prospects.
Stephanie Fagan: These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes.
Stephanie Fagan: These and other risk factors are described in the filings made with the SEC and the applicable Canadian securities regulators, including our annual report on Form 10-K and our Form 10-Q file today.
Stephanie Fagan: Forward-looking statements are based on the assumptions, opinions, and estimates of management at the date the statements are made.
Stephanie Fagan: including the non-occurrence of the risks and uncertainties that are described in the filings made with the FEC and the applicable Canadian securities regulators or other significant events occurring outside of MindMed's normal course of business.
Stephanie Fagan: You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, November 7, 2024.
Speaker Change: MineNet disclaims any obligation to update such statements, even if management's views change, except as required by law. With that, let me turn the call over to Rob.
Thank you, Stephanie, and everyone for joining our call today.
Rob Barrow: I'm pleased to share our progress for the third quarter, which builds upon our strong execution throughout the first half of the year.
Rob Barrow: This has been an incredible year for MindMed, and we are even more excited about what lies ahead as we embark on our Phase 3 programs for MM120 Orally Disintegrating Tablet, or ODT, and Generalized Anxiety Disorder, or GAD, and then Major Depressive Disorder, or MDD.
Rob Barrow: We remain on track to initiate our first phase 3 study of MN120ODT and GAD, called the VOYAGE study, by the end of this year.
Rob Barrow: We also remain on track to initiate our second Phase 3 study of MM120-ODT and GAD, called the Panorama Study, and our first Phase 3 study of MM120-ODT and MDD, called the Emerge Study, in the first half of 2025.
Rob Barrow: These two indications, which together affect approximately 51 million adults in the U.S., have seen little innovation in the past quarter century and represent a significant unmet medical need.
Rob Barrow: We believe MM120-ODT represents a potentially transformational treatment for these populations.
Rob Barrow: and, if approved, could offer patients a differentiated and compelling option in both GAD and MVD, positioning it as a best-in-class and our vision of a first-in-class treatment option targeting two of the most significant unmet needs in psychiatry.
Rob Barrow: We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic.
Rob Barrow: As we progress toward the possibility of bringing MM120-ODT to patients in need, we recognize and embrace the unique opportunities and challenges that lie ahead to deliver and scale this potential.
Rob Barrow: While there is undoubtedly work to do in the coming years, our engagements with patients, prescribers, sites of care, and other key stakeholders have affirmed the broad recognition of the significant unmet medical need and the enthusiasm for the potential of MM120-ODT if approved, given the data we have generated to date.
Rob Barrow: We are continuing to demonstrate this unmet need by producing strong evidence on the enormous impact that these disorders have on patients.
Rob Barrow: For example, at the European College of Neuropsychopharmacology, or ECMP, Congress, in September,
Rob Barrow: We shared an analysis from the 2022 U.S. National Health and Wellness Survey showing that even small increases in the severity of GAD can significantly worsen the quality of life for patients.
Rob Barrow: Additionally, last month, we presented a poster at the Academy of Managed Care Pharmacy Nexus 2024 meeting, highlighting the major economic burden of GAD represented by significant increases in hospitalizations, absenteeism, and reductions in overall productivity.
Rob Barrow: As we progress our commercial plans, we intend to continue strengthening this body of evidence with the goal of enabling patient access and engaging with the key stakeholders needed to bring this potential into reality.
Rob Barrow: Before turning the call over to Dan, I'd like to highlight a few key points about our Phase III development strategy for MM120-ODT, which leverages the strong Phase IIb results we presented earlier this year, and our partnership with FDA under the Breakthrough Therapy Designation Program.
Rob Barrow: A core principle of our development approach is to design clean studies that deliver clear results and are efficient to operationalize.
Rob Barrow: This principle is exemplified by our bold and unique decision early in development to eliminate psychotherapy and by our streamlined Phase III clinical trial designs, which aim to replicate the rapid and durable response after a single dose of MM120 that we observed in our Phase IIb study.
Rob Barrow: A methodological matter that has received a heightened amount of attention recently is functional and blinding and its impact on trials of psychedelics.
Rob Barrow: To state the obvious, MM120ODT and other drugs in the class have a clear perceptual effect for several hours after administration.
Rob Barrow: While the qualitative nature of these effects may be unique, the reality of functional limb blinding in psychiatry is common to virtually every approved psychiatric drug.
Rob Barrow: Nonetheless, we have implemented several strategies intended to address this and other methodological considerations across our Phase II and III programs.
Rob Barrow: These include using central raters who are blinded to both treatment assignment and visit number, incorporating questionnaires to assess potential expectancy bias and unmasking, and in multiple of our studies, including additional control arms that are perceivable but not clinically active.
Rob Barrow: Our continued interactions with the FDA further support alignment with the rigor and design of our approach. And we believe our development strategy can deliver clear and compelling evidence on the safety and effectiveness of MM120-ODT in both GAD and MDT.
Rob Barrow: Operationally, we anticipate streamlined and efficient patient enrollment across both of our Phase 3 programs, given the closely aligned design of our protocols for both the GAD and MDD indications.
Rob Barrow: Our operational efficiency is enhanced by the inclusion of many of our highest performing sites from Phase 2 in our Phase 3 program.
Rob Barrow: Additionally, the planned sample size of Voyage is the same as our Phase 2b study, which we enrolled in approximately 12 months, and Voyage will also benefit from having 50% more sites than our Phase 2b study.
Rob Barrow: Our clinical protocols are designed with operational input from sites and specific attention to enabling enrollment so that we can rapidly recruit a representative sample of participants.
Rob Barrow: Our clinical team and entire R&D organization continue to lead the field in quality and efficiency of execution, and we seek to build on that momentum going into our Phase III programs.
Rob Barrow: We are invigorated by the enthusiasm expressed by patients, trial sites, and study investigators and believe this broad enthusiasm will continue to support our goals of rapid progression and seamless execution in Phase 3.
Speaker Change: Now, let me turn the call over to Dr. Dan Karlin, Chief Medical Officer of MindMed, to discuss our clinical development programs in more detail. Dan?
Thank you, Rob.
Speaker Change: Our development plan for GAD includes two pivotal clinical studies, Voyage and Panorama. Each study will consist of two parts. Part A is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120-ODT versus placebo.
Speaker Change: Part B is a 40-week extension period with opportunities for open label treatment designed to provide important long-term data on the durability and treatment patterns for MM120-ODT.
Speaker Change: VOYAGE is anticipated to enroll approximately 200 participants, randomized one-to-one to receive MM120-ODT 100 micrograms or placebo.
Speaker Change: Panorama is anticipated to enroll approximately 240 participants, randomized 5 to 2 to 5, to receive MM120 ODT 100 micrograms, MM120 ODT 50 micrograms, or placebo.
Speaker Change: In accordance with FDA guidance and our regulatory discussions to date, our clinical program for MM120-ODT continues to use complementary study designs intended to address key methodological considerations such as functional unblinding and participant selection.
Speaker Change: For example, in Panorama, we have included a 50-microgram arm to confound participants' ability to accurately assess the dose condition to which they have been randomized.
Speaker Change: This approach builds on our Phase 2B evidence where we demonstrated that despite functional and blinding at all tested doses, the lower doses, 25 and 50 micrograms, did not demonstrate a meaningful clinical response.
Speaker Change: This supports our view that the anxiolytic effect of MM120 is a true response to the treatment.
Speaker Change: While we previously observed an almost eight-point improvement for MM120 over placebo at week 12, both Voyage and Panorama have been designed to have 90% power to detect a five-point improvement over placebo based on certain statistical assumptions.
Speaker Change: Additionally, both studies will use an adaptive design with an interim blinded sample size re-estimation, which allows for an increase in sample size of up to 50% in each study.
Speaker Change: This approach helps adjust for unexpected variability in nuisance parameters, specifically dropout rates and pooled variants of AMA response, maintaining statistical power, and enhancing the interpretability of our results.
Speaker Change: Key elements, such as inclusion and exclusion criteria, will largely mirror our successful Phase 2B trial of MM120 and GAD.
Speaker Change: Both phase 3 studies will recruit adults aged 18 to 74 with a diagnosis of GAD and a HAM-A score of 20 or greater.
Speaker Change: During Part B of our Phase 3 studies, investigators will closely monitor participants using electronic patient-reported outcomes, central radar-assessed HAMAs, and other clinician-administered scales.
Speaker Change: Participants will be eligible for treatment with MM120 ODT 100 micrograms if their HAM-A score reaches 16 or higher with up to four treatments available through Part B.
Speaker Change: Key outcomes from Part B will include time to repeated treatment or inefficacy.
Speaker Change: We will also assess safety data on repeated treatments, average treatments per year, and response to these treatments. This information will be valuable in understanding the longer-term dynamics of MM120 ODT treatment in GAD patients.
Speaker Change: Overall, both Voyage and Panorama are designed to be consistent with our successful Phase 2B trial of MM120 in GAD, including using the HAM-A as our primary outcome measure.
Speaker Change: The primary endpoint for the Phase III programs is the change from baseline to Week 12, which is consistent with the durability we observed in Phase IIb.
Speaker Change: As Rob mentioned earlier, we remain on track to initiate Voyage by the end of this year and initiate the second Phase III study, Panorama, in the first half of 2025. We anticipate top-line data from Part A of Voyage in the first half of 2026 and from Part A of Panorama in the second half of 2026.
Speaker Change: Turning to MM120 ODP for the treatment of MDD. We are excited about the expansion of our pipeline.
Speaker Change: Data from our phase 2 GAD study led to our decision to pursue MDD as an additional indication for MM120-ODT given its demonstrated potential for antidepressant effects.
Speaker Change: In the 100 microgram dose group in our phase 2b, we observed an 18.7 point improvement from baseline in the Montgomery Asperg Depression Rating Scale, or MADRS, at week 12.
Speaker Change: This represented a 6.4 point advantage over placebo which was statistically significant with a p-value less than 0.01
Speaker Change: These results are particularly encouraging given that the study wasn't powered for this end point and that baseline Madras scores were lower than we would expect in patients experiencing a major depressive episode, which appeared to create a ceiling effect on the response to MM120 as measured by the Madras.
Speaker Change: Like the Phase III development program in GAD, our MDD program will consist of two pivotal clinical studies.
Our first study, Emerge, will be comprised of two parts.
Speaker Change: And Part B is a 40-week extension period during which participants will be eligible for open-label treatment with MM120-ODT subject to certain conditions for treatment eligibility.
Speaker Change: The primary endpoint in eMERGE will be the change from baseline in mattress score at week 6 between MM120, ODT100, micrograms, and placebo.
Speaker Change: The design and timing of a second MDD study will be informed by the progress from eMERGE and additional regulatory discussions.
Rob Barrow: With that update, I will turn the call back over to Rob to discuss third quarter financial results. Rob?
Rob Barrow: Thanks, Dan. Turning to our financial results for the quarter ended September 30th, 2024, we ended the quarter with cash and cash equivalents totaling $295.3 million, compared to $99.7 million as of December 31st, 2023.
Rob Barrow: We believe that our cash and cash equivalents, as of September 30, 2024, will be sufficient to fund our operations into 2027.
Rob Barrow: Importantly, we believe that we have sufficient cash to extend our runway at least 12 months beyond the top-line data readout for our first phase 3 study of the MN-120 ODT and GAD.
Rob Barrow: Research and development expenses were $17.2 million for the quarter ended September 30, 2024, compared to $13.2 million for the same period in 2023.
representing an increase of four million dollars.
Rob Barrow: The increase was primarily due to increases of $2.1 million in expenses related to MM120-ODT's advancement into pivotal studies in GAD.
Rob Barrow: an increase of $0.9 million in expenses related to our MN-402 program, an increase of $0.6 million in internal personnel costs as a result of increasing research and development capacities,
Rob Barrow: and an increase of $0.4 million in expenses related to preclinical activities.
Rob Barrow: We do anticipate R&D expenses to ramp up in 2025 as we get the second phase 3 study in GAD and our first phase 3 study in MDD up and running.
Rob Barrow: General and administrative expenses were $7.6 million for the quarter ended September 30th, 2024, compared to $8.4 million for the quarter ended September 30th, 2023, a decrease of $0.8 million.
Rob Barrow: The decrease was primarily attributable to lower spending in legal and commercial activities, partially offset by increased stock-based compensation expense.
Rob Barrow: The company's net loss for the quarter ended September 30, 2024, was $13.7 million, compared to $17.9 million for the same period in 2023, a decrease of $4.2 million.
Rob Barrow: Decrease was primarily due to changes in the fair value of the warrants issued in our September 2022 underwritten offering of $5.3 million, partially offset by an increase in research and development expense.
Rob Barrow: In closing, MindMen is entering a pivotal phase in our growth with several key milestones expected in the next few years.
Rob Barrow: We believe successfully completing three Phase III studies will drive significant value, and we are focused on maintaining our strong track record of execution as we advance our NN120 ODT Phase III studies and build out the organization with key capabilities for continued success.
Rob Barrow: We believe MM120-ODT represents a novel and highly differentiated treatment option for people living with GAD and MDD.
Rob Barrow: The brain health crisis continues to persist and grow, and bringing forward transformational innovation that will potentially benefit millions of people is what unites us at MindMed.
Rob Barrow: I'm very proud of the efforts of our team and want to thank them for their dedication as we work to deliver on the therapeutic potential of our pipeline and reshape the treatment landscape for people living with brain health disorders.
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. At this time, we will conduct a question and answer session.
Speaker Change: To ask a question during this session, you need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while I compile the Q&A roster.
Speaker Change: The first question comes from Mark Goodman from Lee Ring Partners. Please go ahead.
Speaker Change: Hi, this is Madhu on the line from MARC. Thanks for taking our questions.
Speaker Change: I thought the functional unblinding data that you presented at the Psych Congress recently was really interesting around the unblinding for central raters
Thank you. Thank you.
Speaker Change: How do you think having fewer arms in the Phase III program could impact central radar unblinding? And is this type of analysis showing lack of central radar unblinding something that would be important for approval? Thanks.
Yeah, thanks so much for the question, Matthew.
Speaker Change: It's certainly that the data set we generated in phase two is going to be an important component of our overall
Speaker Change: data package we try to take to a submission. So, when we look at the results, which you're mentioning, which for everyone's sake, demonstrated that 80% of the rating events in our Phase 2 study,
The Raiders.
Speaker Change: described as being unsure of whether or not the patient received active drug or placebo. And where there was a guess, they were generally wrong and in a pretty uniform distribution across all of the treatment arms.
Speaker Change: Those data are particularly informative because we had the five arms in that study and so we can look at the study somewhat in isolation as evidence that functional unblinding
Speaker Change: both at the patient level, didn't have an impact on the study outcomes, as we saw consistent functional and bonding across all treatment groups, but only two of the groups actually respond statistically and clinically significantly, and then from a RADAR standpoint, it speaks to the
the clarity and the uncertainty with which
Speaker Change: there was any unblinding that came out during the structured interviews for the primary endpoint. So we don't certainly have an expectation that that would dramatically change as we go forward into the Phase 3 program. Those data on functional unblinding, I think as we mentioned during the call, are
Speaker Change: something that is extremely common in psychiatry, functional unblinding is the reality for virtually every psychiatry drug. And so while an area of
can increase scrutiny and focus.
Speaker Change: in our discussions with the agency and certainly our anticipation of
Speaker Change: as we continue the development program. These will be supportive and informative, but at the end of the day, what we need to demonstrate is the safety and effectiveness of the drug, and in so doing, should be held to the same regulatory standard of all previous drugs, which is to show a statistical and clinically meaningful difference over the placebo.
Thank you so much.
Thank you.
One moment for our next question.
Speaker Change: Our next question comes from Brian Abrams from RBC Capital Markets. Please go ahead.
Speaker Change: Hi, everyone. This is Nevinan for Brian. Thank you for taking our questions. So, following some recent commentary from another psychedelics competitor,
Speaker Change: in depression concerning some trial recruitment difficulties that they were seeing.
Speaker Change: Do you think this might be an indication-specific problem or perhaps due to the specific trial design given that...
Speaker Change: Dan mentioned some specific issues surrounding finding therapists and getting appointments in spaces. And then how are you looking to maybe reduce some of that friction that might be there with any enrollment difficulties?
Speaker Change: Yeah, thanks, that was a great question. You know, our team, I cannot say enough about our clinical development team and how incredibly well they can operationalize these protocols, even when we look back to our phase 2 study, the pace at which we were able to enroll that study in GAD.
Speaker Change: really set the standard for the field and was faster than we've seen in virtually any other study. And we certainly expect and plan to continue to set the standard for the field in that way. I'll say we have a very hands-on, close
Speaker Change: There are logistical challenges with the conduct of these studies, but that's why we have the experts on our team to navigate that and an ability to really seamlessly execute and get those sites set up and get patients scheduled for dosing. So we have not seen any change
Speaker Change: that would indicate anything other than a continuation of the success we had in enrolling the study in phase two. And so I want to continue building on that.
Speaker Change: As we go forward, again, we have around 30 sites in the VOYAGE study, which is the same size as our Phase 2 study, where we had 20 sites. So, even there, we'll have additional sites while targeting only the same number of patients.
Speaker Change: You know, we got a great length across the board, everything from the degree of our site engagement to central and local recruiting campaigns, but there's also a dynamic of, you know, it was an intentional choice for us to go after.
Speaker Change: The broader markets, both from a commercial standpoint, but also to operationalize these studies going after a general GAD and a general MDD population allows us the largest opportunity to access those patients, but in trials also allows us
Speaker Change: the greatest ease in getting those patients screened and into our studies. And then when we think about across these programs, by having both GAD and NBD up and running at the same sites in many instances,
Speaker Change: It gives us a high degree of efficiency so that the patients who are screened for one indication, but are, for instance, have a major depressive disorder,
Speaker Change: and a major depressive episode could then be moved over into it to the MDD study. So everything about the study design through to how we operationalize it is intended to go.
efficiently, quickly, with the highest possible quality.
Speaker Change: and again, every expectation that we'll continue executing as we go forward into phase three.
Excellent, thank you so much.
Thank you. One moment for our next question.
Speaker Change: Our next question comes from Charles Duncan from Cantor. Please go ahead.
Charles Duncan: Hey, good afternoon, Rob and team. Thanks for all the information on the trial designs. That was quite helpful. I did have a follow-up question to the last one, and that is regarding enrollment pacing.
Charles Duncan: What would you anticipate? It does seem like you're going to be using more sites, but some of them are somewhat naïve to evaluating LSD. And so I guess if you think back to the Phase 2b experience, could you assume a similar time frame
Charles Duncan: for that voyage study to enroll, or could it pace even more quickly than what you showed in the first go-round?
Speaker Change: Yes, thanks so much, Charles. So, our guidance for the first study is that we'll have top line.
Speaker Change: read out from Part A of the study in the first half of 2026, and for the other two Phase III studies, it will be in the second half of 2026.
Speaker Change: That is certainly something that we believe we're on track to execute and do. We will, of course, be trying to streamline and accelerate enrollment at every opportunity and think the team is doing an incredible job at getting these sites.
Speaker Change: up and running and ultimately are excited about the enthusiasm we see both from potential participants in the study, but also the investigative sites in particular.
Speaker Change: While we can't really speak to specific enrollment rates on any given month, we certainly believe we're on track and in a great position to execute on these studies.
Speaker Change: If I heard Dan correctly, he mentioned that there was an interim analysis that would be useful for conditional powering, for using an adaptive design. What triggers that interim analysis? Could you give us a sense of the number of patients or some other milestone?
Speaker Change: At a really high level, I'd say generically, typically those analyses are done somewhere around the time of the halfway enrollment mark in studies.
Thank you.
Speaker Change: We certainly think we would be generally in line with that sort of timeline to enroll. About half of the participants would be a reasonable time to take a look in a blinded fashion, conduct the
Speaker Change: blinded sample size re-estimation and determine if there's a slight increase in sample size required to maintain the power that we've established at the beginning of the study.
Speaker Change: And then my final question is regarding the GAD patient population or sample that you intend to enroll.
Speaker Change: Other phenotypic pieces of information such as durations and symptom onset or prior therapies and are you restricting enrollment on either of those phenotypic, you know, call it characters?
Speaker Change: Yeah, I'll turn this one over to Dan. Yeah, thanks for the question, Charles. Nice to hear from you. So, while the enrollment criteria for the HAMA is set at 20, we absolutely will track a ton of other phenotypic details, certainly including treatment history.
Speaker Change: treatment that someone might come to screening with the need to be tapered off certainly we would be aware of those but we get a more detailed treatment history so both you know that they have had some number of treatments and what those treatments are and their duration and this sort of thing so while we don't use prior treatment as a
Speaker Change: inclusion or exclusion criteria, we certainly will be able to look at the performance of the drug based on.
phenotypic data like that at entry.
Were any of those phenotypic details drivers to...
call it efficacy or even enrollment in the Phase 2b.
Speaker Change: You'll recall that the 40 per arm design of the Phase IIb was pretty small on a per arm basis. So, while we can, you know, of course we slay some data and try to tease out anything we can, but with the group sizes we work our way down to.
Speaker Change: we weren't detecting any difference in any predictors of response there.
Speaker Change: Got it. Thanks for the reminder. Looking forward to seeing this one kick off soon. Thanks. Thanks so much.
Thank you. One moment for our next question.
Speaker Change: Our next question comes from Francois Brizobras from Oppenheimer. Please go ahead.
Francois Brizobras: Thanks for the question. I was just wondering, is there any chance, any thought about waiting for Part B before reading out Part A, or is this kind of a classic Part A happens, you have the data, and you read it out? Then I have follow-ups.
Speaker Change: Yeah, thanks, Frank. No, we intend to, once we complete the 12-week portion of our study to
Speaker Change: locked the database for that portion of the study and read out the top-line results there. So certainly while patients will continue on, and we do not anticipate on individual patient basis
Speaker Change: blinding or telling those patients what they received in Part A of the study, we certainly have the capability, like in any study, to lock and provide an analysis of the group results.
Okay, great. And on, this is a kind of a.
Speaker Change: Writting out the prior questions from Charles here, the interim readout.
Speaker Change: Thanks for the question. No, no, the blinded interim re-estimation, so this adaptive design, there's no alpha spend or
and the pooled distribution of HAMA scores.
that those are consistent with the assumptions we've made.
Speaker Change: We don't look at anything about the group's actual response from baseline or versus one another. It's simply to make sure that a nuisance parameter doesn't reduce the actual realized power in the study. So we won't be testing for futility or early efficacy or spending any alpha or doing any inferential tests at that time.
Speaker Change: Great, and then lastly, and I don't know if you're willing or want to comment on this, but any thoughts on the elections and what it can do to the space? Thank you.
Speaker Change: Yeah, no, it's certainly been an eventful political week. We've had broad engagement with both state-level, local, and federal officials.
Speaker Change: in many branches of government and have seen the broad awareness of the
Speaker Change: and brain health disorders in this country and certainly anxiety and depression having grown substantially and being so
Speaker Change: burdensome on patients and from a public health standpoint we see
Speaker Change: in a broad willingness to engage and a really broad enthusiasm for the potential that this could represent.
Thank you.
Thank you.
Thank you.
Speaker Change: Now, as a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. One moment for our next question.
Speaker Change: Our next question comes from Patrick Truccio from HC Wainwright. Please go ahead. Thanks. Good afternoon and congrats on all the progress. The first question is just to what extent you would expect the readout from Voyage
Speaker Change: the MDD program, I'm just curious, you know, what are you looking to learn from additional regulatory discussion regarding the second?
Speaker Change: potential phase three trial, and is there a possibility you might be able to move forward with just the single, just one phase three trial?
Speaker Change: Thanks so much. On that latter point, I'll just say that we certainly anticipate doing two studies. We always look for opportunities to accelerate our programs, but we'll certainly
have plans in place and what will be.
Speaker Change: exploring further the timing and an exact design of that second study. In terms of those regulatory interactions, it's simply a matter of ensuring that we have complete alignment from a programmatic standpoint across the indications, but especially in
Speaker Change: and depression that we in the second study is aligned with what would be required for for a submission for that indication. So as that unfolds and as we get clarity on the exact timing and design of the study we'll certainly be announcing it at a later date.
Speaker Change: And in terms of read-through, you know, certainly as we continue to build a body of evidence,
Thank you.
Speaker Change: and hopefully see as compelling of results as we saw from the Phase 2 study. You know, we want to demonstrate consistency in response, I think, certainly with the complementary designs that we were using across
are phase two and three programs. We have...
Speaker Change: everywhere from a five-arm study that we conducted in phase two.
Speaker Change: to now two- and three-arm studies that we're conducting in phase three. We want to see a consistent response. We ideally see a continued response to MM120.
Speaker Change: and to the extent we see really promising results from a first phase 3, it certainly will continue to build our confidence in the repeatability of that.
Right.
Speaker Change: And then if I could, just a follow-up question on the functional and blinding discussion from earlier. I'm just curious, you know, with the, particularly with the VOYAGE trial, just the importance of showing a dose response.
Speaker Change: and also just as far as the, you know, 40-week extension and I guess the kind of the long-term follow-up data. Can you talk about how this data could help just in terms of sort of addressing that question around functional and blinding and any other bias?
Speaker Change: Yes, sir. I think the functional and blinding come in again. Functional and blinding.
Speaker Change: I don't think anyone in the field really believes that for patients who take the active dose of drugs that there's a likelihood that they will have no idea on average. What we try to do is use these complementary designs across the program so that we're addressing
Speaker Change: indicated moving forward with a hundred microgram dose which we're taking into phase three.
We also saw that the pairwise comparisons demonstrated statistical significance.
Speaker Change: of the 100-microgram group versus placebo. So we are very confident that we have rigorously established the dose response of immune 120. As we go forward, the lower dose being used in panorama, our second phase three study.
Speaker Change: getting a little background there, but a lower dose being used as a secondary control in panorama.
is really intended to...
Speaker Change: confuse someone. So entering the study may have an expectancy, but by knowing that the lower dose is there, that a dose that is clearly perceivable, but we've shown in phase two is clinically not active, that that would mitigate the
Speaker Change: the connectivity between it and expectancy bias and those clinical outcomes which is is mediated by by functional unblinding and and so doing it it aims to
Speaker Change: the view again across the program. Now we've already done that in phase two, so there again we feel highly confident that based on the phase two data we are seeing a response that is not simply driven by functional blinding. We'll at the end of the day have three studies with
Speaker Change: that seek to build a body of evidence across that full program that we're seeing a true drug effect. But certainly what we've observed to date, we feel is the best data available to anyone in the field to support that conclusion, and we'll continue building on that in the Phase III program.
Great. Thank you so much.
Thank you. One moment for our next question.
Speaker Change: Our next question comes from Jason McCarthy from Maxim Group. Please go ahead.
Speaker Change: Hey guys, this is Michael Okinowichan. Thank you for taking my questions today.
Speaker Change: So, I guess just one from me, I'd like to ask a little bit with, you know, with COMPASS's data delay.
Speaker Change: Is there any added risk on the delivery side since we're no longer likely to have another long-acting psychedelic approved and on the market significantly ahead of MM120 to drive that expansion of the delivery into infrastructure?
Speaker Change: Yeah, thanks for the question, Michael. I'd say we're extremely excited and confident to be shaping this market and believe as we've been able to execute.
in the clinical development programs that our team's ability to.
Speaker Change: again set the standard for the field in terms of real-world delivery. It's something we'll be pursuing and that's...
Speaker Change: Something that we'll be pursuing regardless of what else happens with other programs or other other organizations But certainly as we progress here, we're very eager to continue those engagements with sites and payers and all the key stakeholders and To again set the standard for the field
Speaker Change: Do you anticipate that having no psychotherapy components could potentially broaden the number of delivery settings that you're able to go into?
Speaker Change: It was certainly a driver of making that decision, both for the integrity of how we deliver and the interpretability of clinical results, but also to try to maximize access we can have for patients at the end of the day. So.
Speaker Change: The delivery modality, what we are pursuing, and how we deliver MM120 is intentional, it's by design, and it's intended to maximize the opportunity for patient access to have a broad impact on the trajectory of these disorders.
Speaker Change: All right. Well, thank you very much, Rob, for taking my question today.
Thank you. Thank you. One moment for our next question.
Our next question comes from Samet.
Calicarni from Connacord Genuity. Please go ahead.
Speaker Change: Good afternoon. Thanks for taking our questions. In your GAD trials, could you remind us, in the open label 40-week extension program, how will you maintain the integrity of the durability of effect that may be attributable solely to MM120 versus other medications that might be used?
Yeah, turn that one over to Dan.
Thanks for the question, Sumon.
Speaker Change: extension phase of these trials have the same restriction on CONMEBs as the double-blind period. Because we're making additional treatment available to folks who need it, we think that
Speaker Change: Given that it's an open data stream, it is not randomized, there will be no real drive for participants to go back onto the server.
Speaker Change: prohibited con meds. So same controls as we used for the for the first portion.
Speaker Change: I guess if you want to map this onto the real world, what level of rescue therapy that does not involve re-dosing with MM120, if any, might be considered to be optimal in a clinical trial setting?
So if I'm following the question...
Speaker Change: What else could they be given, is the question? Yes, exactly. That and, you know, how many of those kinds of events would you expect? Clearly, there's always going to be some responders, non-responders, all of that. But if someone does respond and then needs rescue, how do you characterize all that?
Speaker Change: Yeah, so the upshot of that Part B extension phase is that if someone responds and then subsequently loses response, they can get up to four open-label treatments during that 40-week period. So the first step would be re-dosing and seeing if that captures and keeps people well.
Speaker Change: have illness that's severe enough that they need to try something else, then they're withdrawn from the study at some point. And we use statistical methods to...
Speaker Change: to the missing data after they leave the study. So that's a decision that is made by IPAs along with, of course, the participants themselves, but certainly, you know, the hope is that by having these open labels
Speaker Change: treatment options that folks are able to stay in for the whole study.
Thank you.
Speaker Change: Thank you. I am showing no further questions. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.