Mind Medicine (MindMed) Q3 2024 Earnings Call Transcript

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Provided by Quartr
November 7, 2024

There are 11 speakers on the call.

Operator

Good afternoon, and welcome to My Medicine Third Quarter 20 24 Financial Results and Corporate Update Conference Call. Currently, all participants are in listen only mode. This call is being webcast live on the Investors and Media section of MindMed's website at mindmed.co, and a recording will be available after the call. I would like to introduce Stephanie Fagan, Chief Corporate Affairs Officer at MyMed. Please go ahead.

Speaker 1

Thank you, operator. Good afternoon, everyone. Thank you for joining us today for a discussion of MindMed's Q3 2024 Business Highlights and Financial Results. Leading the call today will be Rob Barrow, our Chief Executive Officer. He will be joined by Doctor.

Speaker 1

Dan Carlin, our Chief Medical Officer and Francois Lowenthal, our Chief Commercial Officer. After our prepared remarks, we will open the call for Q and A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. 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, our anticipated cash runway and 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 and regulatory approval processes.

Speaker 1

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 ks and our Form 10 Q filed today. Forward looking statements are based on the assumptions, opinions and estimates of management at the date the statements are made, including the non occurrence of the risks and uncertainties that are described in the filings made with the SEC and the applicable Canadian securities regulators or other significant events occurring outside of MyMed's normal course of business. You are cautioned not to place undue reliance on these forward looking statements, which are made as of today, November 7, 2024. Mylan 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.

Speaker 2

Thank you, Stephanie, and to everyone for joining our call today. I'm pleased to share our progress for the Q3, which builds upon our strong execution throughout the first half of the year. 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 in major depressive disorder or MDD. We remain on track to initiate our 1st Phase 3 study of MM120 ODT and GAD called the VOIDGE study by the end of this year. We also remain on track to initiate our 2nd Phase 3 study of MM120 ODT and GAD called the PANORAMA study and our 1st Phase 3 study of MM120 ODT and MDD called the EMERGE study in the first half of twenty twenty five.

Speaker 2

These two indications, which together affect approximately 51,000,000 adults in the U. S, have seen little innovation in the past quarter century and represent a significant unmet medical need. We believe MM120 ODT represents a potentially transformational treatment for these populations and if approved could offer patients a differentiated and compelling option in both GAD and MDD, positioning it as a best in class and our vision of a 1st in class treatment option targeting 2 of the most significant unmet needs in psychiatry. We aspire to deliver a truly transformational treatment that we believe has the potential to change the trajectory of the ongoing brain health epidemic. 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.

Speaker 2

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 a significant unmet medical need and the enthusiasm for the potential of MM120 ODT if approved given the data we have generated to date. We are continuing to demonstrate this unmet need by producing strong evidence on the enormous impact that these disorders have on patients. For example, at the European College of Neuropsychopharmacology or ECMP Congress in September, 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.

Speaker 2

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. 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. Before turning the call over to Dan, I'd like to highlight a few key points about our Phase 3 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. A core principle of our development approach is to design clean studies that deliver clear results and are efficient to operationalize. This principle is exemplified by our bold and unique decision early in development to eliminate psychotherapy and by our streamlined Phase 3 clinical trial designs, which aim to replicate the rapid and durable response after a single dose of MM120 that we observed in our Phase 2b study.

Speaker 2

A methodological matter that has received a heightened amount of attention recently is functional and blinding and its impact on trials of psychedelics. To state the obvious, MM120 ODT and other drugs in the class have a clear perceptual effect for several hours after administration. While the qualitative nature of these effects may be unique, the reality of functional unblinding in psychiatry is common to virtually every approved psychiatric drug. Nonetheless, we have implemented several strategies intended to address this and other methodological considerations across our Phase II and III programs. 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.

Speaker 2

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 MN-one hundred and twenty ODT in both GAD and MDD. Operationally, we anticipate streamlined and efficient patient enrollment across both of our Phase III programs, given the closely aligned design of our protocols for both the GAD and MDD indications. Our operational efficiency is enhanced by the inclusion of many of our highest performing sites from Phase II in our Phase III program. Additionally, the planned sample size of Voyage is the same as our Phase IIb study, which we enrolled in approximately 12 months, and Voyage will also benefit from having 50% more sites than our Phase IIb study. 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.

Speaker 2

Our clinical team and entire R and 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. 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. Now, let me turn the call over to Doctor. Dan Carlin, Chief Medical Officer of MindMed to discuss our clinical development programs in more detail. Dan?

Speaker 3

Thank you, Rob. Our development plan for GAD includes 2 pivotal clinical studies, Voyage and PANORAMA. Each study will consist of 2 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. 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 3

Voyage is anticipated to enroll approximately 200 participants randomized 1 to 1 to receive MM120 ODT 100 micrograms or placebo. PANORAMA is anticipated to enroll approximately 2 40 participants randomized 5 to 2 to 5 to receive MM120 ODT 100 micrograms, MM120 ODT 50 micrograms or placebo. 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. For example, in PANORAMA, we've included a 50 microgram arm to confound participants ability to accurately assess the dose condition to which they have been randomized. This approach builds on our Phase 2b evidence where we demonstrated that despite functional and blinding at all tested doses, the lower doses 25 50 micrograms did not demonstrate a meaningful clinical response.

Speaker 3

This supports our view that the angiolytic effect of MM120 is a true response to the treatment. While we previously observed an almost 8 point improvement for MM120 over placebo at week 12, both Voyage and PANORAMA have been designed to have 90% power to detect a 5 point improvement over placebo based on certain statistical assumptions. Additionally, both studies will use an adaptive design with an interim blinded sample size estimation, which allows for an increase in sample size of up to 50% in each study. This approach helps adjust for unexpected variability and nuisance parameters, specifically dropout rates and pooled variance of HAMA response, maintaining statistical power and enhancing the interpretability of our results. Key elements such as inclusion and exclusion criteria will largely mirror our successful Phase 2b trial of MM120 and GAD.

Speaker 3

Both Phase 3 studies will recruit adults aged 18 to 74 with a diagnosis of GAD and a HAMA score of 20 or greater. During Part B of our Phase 3 studies, investigators will closely monitor participants using electronic patient reported outcomes, central rater assessed AMAs and other clinician administered scales. Participants will be eligible for treatment with MM120 ODP-one hundred micrograms if their PAM ACE score reaches 16 or higher with up to 4 treatments available through Part B. Importantly, we believe the study design allows for an assessment of the durability of the treatment effect, the need for and response to retreatment and the long term safety of MM120 ODT. Key outcomes from Part B will include time to repeated treatment or inefficacy.

Speaker 3

We will also assess safety data on repeated treatment, 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. Overall, both Voyage and PANORAMA are designed to be consistent with our successful Phase 2b trial of MM120 in GAD, including using the HAMA as our primary outcome measure. The primary endpoint for the Phase 3 programs is the change from baseline to week 12, which is consistent with the durability we observed in Phase 2b. As Rob mentioned earlier, we remain on track to initiate Voyage by the end of this year and initiate the 2nd Phase 3 study PANORAMA in the first half of twenty twenty five.

Speaker 3

We anticipate top line data from Part A of Voyage in the first half of twenty twenty six and from Part A of Panorama in the second half of twenty twenty six. Turning to MM120 ODT for the treatment of MDD, we are excited about the expansion of our pipeline. 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. In the 100 microgram dose group in our Phase 2b, we observed an 18.7 point improvement from baseline in the Montgomery Asper Depression Rating Scale or MADRS at week 12. This represented a 6.4 point advantage over placebo, which was statistically significant with a p value less than 0.01.

Speaker 3

These results are particularly encouraging given that the study wasn't powered for this endpoint and that baseline MADRS 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 MADRS. Like the Phase 3 development program in GAD, our MDD program will consist of 2 pivotal clinical studies. Our first study, EMERGE, will be comprised of 2 parts. Part A, a 12 week randomized double blind placebo controlled parallel group study assessing the efficacy and safety of a single dose of MM120 ODT versus placebo. And Part B, 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 3

IMVERGE is anticipated to enroll at least 140 participants with a primary diagnosis of MDD randomized 1 to 1 to receive MM120 ODT 100 micrograms or placebo. The primary endpoint in IMerge will be the change from baseline in MADRS score at week 6 between MM120 ODT 100 micrograms and placebo. The design and timing of the second MDD study will be informed by the progress from IMerge and additional regulatory discussions. With that update, I will turn the call back over to Rob to discuss Q3 financial results. Rob?

Speaker 2

Thanks, Dan. Turning to our financial results for the quarter ended September 30, 2024, we ended the quarter with cash and cash equivalents totaling $295,300,000 compared to $99,700,000 as of December 31, 2023. We believe that our cash and cash equivalents as of September 30, 2024 will be sufficient to fund our operations into 2027. 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 MM120 ODT and GAD. Research and development expenses were $17,200,000 for the quarter ended September 30, 2024 compared to $13,200,000 for the same period in 2023, representing an increase of $4,000,000 The increase was primarily due to increases of $2,100,000 in expenses related to MN-one hundred and twenty ODT's advancement into pivotal studies in GAD, an increase of $900,000 in expenses related to our MM402 program, an increase of $600,000 in internal personnel costs as a result of increasing research and development capacities, and an increase of $400,000 in expenses related to preclinical activities.

Speaker 2

We do anticipate R and D expenses to ramp up in 2025 as we get the 2nd Phase 3 study in GAD and our 1st Phase 3 study in MDD up and running. General and administrative expenses were $7,600,000 for the quarter ended September 30, 2024 compared to $8,400,000 for the quarter ended September 30, 2023, a decrease of $800,000 The decrease was primarily attributable to lower spending in legal and commercial activities, partially offset by increased stock based compensation expense. The company's net loss for the quarter ended September 30, 2024 was $13,700,000 compared to $17,900,000 for the same period in 2023, a decrease of $4,200,000 Decrease was primarily due to changes in the fair value of the warrants issued in our September 2022 underwritten offering of $5,300,000 partially offset by an increase in research and development expense. In closing, MindMed is entering a pivotal phase in our growth with several key milestones expected in the next few years. We believe successfully completing 3 Phase 3 studies will drive significant value and we are focused on maintaining our strong track record of execution as we advance our MN-one hundred and twenty ODT Phase 3 studies and build out the organization with key capabilities for continued success.

Speaker 2

We believe MM120 ODT represents a novel and highly differentiated treatment option for people living with GAD and MDD. 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. 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 the treatment landscape for people living with brain health disorders. 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.

Operator

Thank you. At this time, we will conduct a question and answer The first question comes from Mark Goodman from Leerink Partners. Please go ahead.

Speaker 4

Hi. This is Madhu on the line for Mark. Thanks for taking our questions. I thought the functional unblinding data that you presented at the site Congress recently was really interesting around the unblinding for central raters. How do you think having fewer arms in the Phase 3 program could impact central rater unblinding?

Speaker 4

And is this type of analysis showing lack of central rater unblinding something that would be important for approval? Thanks.

Speaker 2

Yes. Thanks so much for the question, Malu. Certainly, the data set we generated in Phase 2 is going to be an important component of our overall data package we try to take to a submission. So when we look at the results which you're mentioning, which took for everyone's sake demonstrated that 80% of the rating events in our Phase 2 study, the raters 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 in a pretty uniform distribution across all of the treatment arms.

Speaker 2

Those data are particularly informative because we had the 5 arms in that study. And so we can look at the study somewhat in isolation as evidence that functional unblinding, both at the patient level, didn't have an impact on the study outcomes, as we saw consistent functional unblinding across all treatment groups, but only 2 of the groups actually respond statistically and clinically significantly. And then from a rater standpoint, it speaks to the clarity and the uncertainty with which 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 and blinding, I think as we mentioned during the call, are something that is extremely common in psychiatry.

Speaker 2

Functional and blinding is the reality for virtually every psychiatry drug. And so while an area of kind of increased scrutiny and focus, in our discussions with the agency and certainly our anticipation of as we develop the continue to develop the 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 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.

Speaker 4

Got it. Thank you so much.

Speaker 3

Thank you.

Operator

One moment for our next question. Our next question comes from Brian Abrahams from RBC Capital Markets. Please go ahead.

Speaker 5

Hi, everyone. This is Nevan on for Brian. Thank you for taking our questions. So following some recent commentary from another psychedelics competitor in depression concerning some trial recruitment difficulties that they were seeing, Do you foresee having any particular difficulties as you look to initiate Voyage and Panorama in NGAD? And then do you think this might be an indication specific problem or perhaps due to the specific trial design given that Dan mentioned some specific issues surrounding finding therapists and getting appointments and spaces?

Speaker 5

And then how are you looking to maybe reduce some of that friction that might be there with any enrollment difficulties?

Speaker 2

Yes. Thanks, Evan. So a great question. 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 really set the standard for the field and was faster than we've seen in virtually any other study.

Speaker 2

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 engagement with all of our clinical sites. We certainly have 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 that would indicate anything other than a continuation of the success we had enrolling the study in Phase 2. And so I want to continue building on that.

Speaker 2

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. We got a great length across the board, everything from the degree of our site engagement to central and local recruiting campaigns. But there is also a dynamic of it was an intentional choice for us to go after 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 the greatest ease in getting those patients screened 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, 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 and a major depressive episode could then be moved over into the MDD study.

Speaker 2

So everything about the study design through to how we operationalize it is intended to go efficiently quickly with the highest possible quality. And again, every expectation that we'll continue executing as we go forward in Phase 3.

Speaker 5

Excellent. Thank you so much.

Speaker 2

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from Charles Duncan from Cantor. Please go ahead.

Speaker 6

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. I guess, what would you anticipate?

Speaker 6

It does seem like you're going to be using more sites, but some of them are somewhat naive to evaluating LST. And so I guess if you think back to the Phase 2b experience, could you assume a similar timeframe for that, voyage study to enroll or could it pace even more quickly than what you showed in the first go round?

Speaker 2

Yes. Thanks so much, Charles. So our guidance for the first study is that we'll have top line readout from Part A of the study in the first half of twenty twenty six and for the other two Phase 3 studies would be in the second half of twenty twenty six. 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 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 2

So 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 6

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 2

Yes. At a really high level, let's say, generically, typically those analyses are done somewhere around the time of the halfway enrollment market studies. And we certainly think we would be generally in line with that sort of timeline. So when we enroll, about half of the participants would be a reasonable time to take a look in a blinded fashion, conduct the 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 6

And then my final question is regarding the GAD patient population that or sample that you intend to enroll. I think Dan mentioned HAMA of 20 or greater being required, but are you planning to track any other phenotypic pieces of information such as durations and symptom onset or prior therapies? And are you restricting enrollment on either of those phenotypic, call it, characters?

Speaker 2

Yes. I'll turn this one over to Dan.

Speaker 3

Yes. Thanks for the question, Charles. Nice to hear from you. So while the enrollment criteria for the Ham A is set at 20, we absolutely will track a ton of other phenotypic details, certainly including treatment history, treatment that someone might come to screening with that need to be tapered off. Certainly, we would be aware of those, but we get a more detailed treatment history.

Speaker 3

So both that they have had some number of treatments and what those treatments are in their duration and this sort of thing. So while we don't use prior treatment as an 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.

Speaker 6

And were any of those phenotypic details drivers to call it efficacy or even enrollment in the Phase 2b?

Speaker 3

You'll recall that the 40 per arm design of the Phase 2b is pretty small on a per arm basis. So while we can of course, we slice and dice those data and try to tease out anything we can. But with the group sizes we work our way down to, we weren't detecting any difference in any predictors of response there.

Speaker 6

Got it. Thanks for the reminder. Looking forward to seeing this one kick off.

Speaker 3

Thanks so much.

Operator

Thank you. One moment for our next question. Our next question comes from Francois Brisebois from Oppenheimer. Please go ahead.

Speaker 7

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-up.

Speaker 2

Yes. Thanks, Frank. No, we intend to once we complete the 12 week portion of our study to lock 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 unblinding 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 analysis of the group results.

Speaker 7

Okay, great. And on this is kind of a riffing off the prior question from Charles here. The interim readout, is there any way that interim could kind of trigger an early stoppage? Like how blinded is this where could it trigger an early stoppage whether or not for either the reason that things are going great and you're there and you can stop or things are not looking good anyway this could trigger some sort of readout prior to the final?

Speaker 2

Yes. Thanks for the question. No, the blinded interim re estimation to this adaptive design, there's no alpha spend or inferential testing that happens. We're simply making sure that at that point that the nuisance parameters that Dan mentioned, right, so that the enrollment, the dropout rate and the variance in the pooled distribution of Ham A scores, that those are consistent with the assumptions we've made. We don't look at anything about the group's actual response from baseline or versus one another.

Speaker 2

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 in virtual tests at that time.

Speaker 7

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

Speaker 3

to the space? Thank you.

Speaker 2

Yes. No, it's certainly been an eventful political week. We've had broad engagement with both state level, local and federal officials in many branches of government and have seen the broad awareness of the and the impact of mental health and brain health disorders in this country and certainly anxiety and depression having grown substantially and being so burdensome on patients and from a public health standpoint, we see broad willingness to engage and a really broad enthusiasm for the potential that this could represent. Thank you.

Operator

Thank you. You. Our next question comes from Patrick Trucchio from H. C. Wainwright.

Operator

Please go ahead.

Speaker 8

Thanks. Good afternoon and congrats on all the progress. The first question is just to what extent you would expect the readout from Voyage to provide a read through to the PANORAMA trial? And the second question is just on the MDD program. I'm just curious, what are you looking to learn from additional regulatory discussion regarding the second potential Phase 3 trial?

Speaker 8

And is there a possibility you might be able to move forward with just the single, just one Phase 3 trial?

Speaker 2

Yes. Thanks so much. On that latter point, I'll just say that we certainly anticipate doing 2 studies. We always look for opportunities to accelerate our programs, But we'll certainly have plans in place and we'll be exploring further the timing and 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 depression that we in the second study is aligned with what would be required for submission to that indication.

Speaker 2

So as that unfolds and as we get clarity on the exact timing and design of the study, we'll certainly be announcing at a later date. And in terms of read through, certainly as we continue to build a body of evidence and hopefully see as compelling of results as we saw from the Phase 2 study, we want to demonstrate consistency in response. I think certainly with the complementary designs that we're using across our Phase II and III programs, we have everywhere from a 5 arm study that we conducted in Phase II to now 2 and 3 arm studies that we're conducting in Phase III. We want to see a consistent response. We ideally see continued response to MM120.

Speaker 2

And to the extent we see really promising results from our first Phase 3, it certainly will continue to build our confidence in the repeatability of that.

Speaker 8

Right. And then if I could, just a follow-up question on the functional and blinding discussion from earlier. I'm just curious with the particularly with the VOYAGE trial, just the importance of showing a dose response and also just as far as the 40 week extension and I guess the kind of the long term follow-up data. Can you talk about how this data could help in just in terms of sort of addressing that question around functional blinding and any other bias?

Speaker 2

Yes. So I think the functional unblinding comment again, functional unblinding will occur. It occurs in every psychiatry trial, certainly with drugs with a clear perceptual effect. We have 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

Speaker 8

that

Speaker 2

we're addressing the questions comprehensively across the full program, but also within individual studies. What we established with statistical and clinical significance in the Phase 2 study was that we have a dose response and that that dose response indicated moving forward with 100 microgram dose, which we're taking into Phase 3. We also saw that the pairwise comparisons demonstrated statistical significance of the 100 microgram versus placebo. So we are very confident that we have rigorously established the dose response of IMU-one hundred and twenty. As we go forward, the lower dose being used in PANORAMA, our second Phase 3 study, I'm getting a little background there, but lower dose being used as a secondary control in PANORAMA is really intended to confuse someone.

Speaker 2

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 Phase 2 is clinically not active, so that would mitigate the connectivity between it and the expectancy bias and those clinical outcomes, which is mediated by functional and binding. And so doing it, it aims to increase the integrity of the view again across the program. Now we've already done that in Phase 2. So there again, we feel highly confident that based on the Phase 2 data, we are seeing a response that is not simply driven by functional and blinding. We'll at the end of the day have 3 studies with different allocation ratios and different controls that seek to build a body of evidence across that full program that we're seeing a true drug effect.

Speaker 2

But certainly what we've observed to date, we feel is that the best data available to anyone in the field to support that conclusion and we'll continue building on that in the Phase 3 program.

Speaker 8

Great. Thank you so much.

Operator

Thank you. One moment for our next question. Our next question comes from Jason McCarthy from Maxim Group. Please go ahead.

Speaker 9

Hey, guys. This is Michael O'Cunich on. Thank you for taking my questions today. So I guess just one from me. I'd like to ask a little bit with COMPASS' data delay.

Speaker 9

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 infrastructure?

Speaker 2

Yes. Thanks for the question, Michael. I'd say we are extremely excited and confident to be shaping this market and believe as we've been able to execute

Speaker 3

in

Speaker 2

the clinical development programs that our team's ability to, again set the standard for the field in terms of real world delivery is something we'll be pursuing and that's something we'll be pursuing regardless of what else happens with other programs or 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 9

Do you anticipate that having no psychotherapy components to potentially broaden the number of delivery settings that you're able to go into?

Speaker 2

It was certainly a driver of making that decision, both for the integrity of how we deliver in the interpretability of clinical results, but also to try to maximize access we can have for patients at the end of the day. So the delivery modality of what we are pursuing and how we deliver M120 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. All right.

Speaker 9

Well, thank you very much, Rob, for taking my questions today.

Speaker 2

Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from Samet Kulkarni from Canaccord Genuity. Please go ahead.

Speaker 10

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?

Speaker 2

Yes. I'll turn that one over to Dan.

Speaker 3

Thanks for the question, Sumant. The extension phase of these trials have the same restriction on CONMEDS as the double blind period because we're making additional treatment available to folks who need it. We think that given that it's not randomized, there will be no real drive for participants to go back on to prohibited Conmeds. So same controls as we use for the first portion.

Speaker 10

Got it. And then in the I guess if you want to map this onto the real world, what level of rescue therapy that does not involve redosing with MM120, if any, might be considered to be optimal in a clinical trial setting?

Speaker 3

So if I'm following the question, you're asking, if someone was not responding to what else could they be given? Is that the question?

Speaker 10

Yes. Yes, exactly. That and 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 3

Yes. So the upshot of that Part B extension phase is that if someone responds and then subsequently loses response, they can get up to 4 open label treatments during that 40 week period. So the first step would be redosing and seeing if that captures and keeps people well. There are in any trial going to be people who don't respond, right. No matter how good your drug is, it doesn't treat everybody and it doesn't treat everybody completely.

Speaker 10

So if

Speaker 3

participants are not responding and ultimately are comfortable and 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 fit 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, the hope is that by having these open label treatment options that the folks are able to stay in for the whole study.

Speaker 2

Thank you.

Operator

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.

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Key Takeaways

  • Phase 3 Milestones: On track to initiate the VOYAGE study for MM120 ODT in GAD by end of 2024 and the PANORAMA (GAD) and EMERGE (MDD) studies in H1 2025, with top-line readouts expected in 2026.
  • MM120 ODT Potential: The oral disintegrating tablet targets generalized anxiety and major depressive disorders affecting some 51 million U.S. adults, seeking to offer a differentiated best-in-class option after 25 years of limited innovation.
  • Streamlined Trial Design: Phase 3 protocols eliminate adjunct psychotherapy, employ central blinded raters, a lower-dose control arm, and adaptive blinded sample-size re-estimation to address functional unblinding and ensure clear efficacy data.
  • Strong Cash Runway: With $295.3 million in cash and equivalents as of September 30 2024, the company expects funding into 2027, covering at least 12 months beyond the first Phase 3 readout.
  • R&D Investment: R&D expenses rose to $17.2 million in Q3 2024 (vs. $13.2 million Y/Y) driven by MM120 pivotal program costs, with further increases anticipated as additional Phase 3 studies commence.
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Earnings Conference Call
Mind Medicine (MindMed) Q3 2024
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