Mind Medicine (MindMed) Inc

F:MMQ

Earnings Call Transcript 2024-Q3

[Operator]

Good afternoon, and welcome to Mind Medicine Third Quarter 2024 Financial Results and Corporate Update Conference Call.

[Operator Instructions]

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 MindMed. Please go ahead.

[Unknown Executive]

Thank you, operator. Good afternoon, everyone. Thank you for joining us today for a discussion of Mine Med's Third Quarter 2024 Business Highlights and Financial Results. 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 Lilienthal, our Chief Commercial Officer. After our prepared remarks, we will open the call for Q&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. These and other risk factors are described in the filings made with the SEC and the applicable Canadian security regulators including our annual report on Form 10-K 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 nonoccurrence 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 MindMed's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, November 7, 2024. MindMed 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.

[Robert Barrow, executive]

Thank you, Stephanie, and to everyone for joining our call today. I'm pleased to share our progress for the third quarter, 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 embarked on our Phase III programs for MM-120, 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 first Phase III study of NM-120-ODT at GAD called the VOYAGE study by the end of this year. We also remain on track to initiate our second Phase III study of MM120-ODT and GAD called the PANORAMA study in our first Phase III study of MM120-ODT and NDD called the EMERGE study in the first half of 2025. These 2 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.

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 first-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 that patients in need, we recognize and embrace the unique opportunities and challenges that lie ahead to deliver and scale this potential.

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 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.

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 III development strategy for MM-120-ODT, which leverages the strong Phase IIb results we presented earlier this year 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 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.

A methodological matter that has received a heightened amount of attention recently is functional and blinding and its impact on trials of psychodelics. Safely obvious 120 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 and blind against 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 receivable but not clinically active. 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 MM-120-ODT in both GAD and MTD.

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. 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.

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 III. Now let me turn the call over to Dr. Dan Karlin, Chief Medical Officer of Mine Med to discuss our clinical development programs in more detail. Dan?

[Daniel Karlin, executive]

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 MM-120-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 MM-120-ODT. Voyage is anticipated to enroll approximately 200 participants, randomized 1:1 to receive MM120-ODTE100 micrograms or placebo. Panorama is anticipated to enroll approximately 240 participants randomized 52 to 5 to receive MM-120-ODT-100 micrograms, MM-120-ODT50 micrograms or placebo.

In accordance with FDA guidance and our regulatory discussions to date, our clinical program for MM-120-ODT continues to use complementary study design 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 IIb 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. This supports our view that the endiolytic effect of MM-120 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 reestimation, which allows for an increase in sample size up to 50% in each study. This approach helps adjust for unexpected variability in nuisance parameters, specifically dropout rates and pooled variances of MMA 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 IIb trial of MM-120 in GAD. Both Phase III studies will recruit adults aged 18 to 74 with a diagnosis of GAD and a HAM-A score of 20% or greater.

During Part B of our Phase III studies, investigators will closely monitor participants using electronic patient reported outcomes, central rater assessed [indiscernible] and other clinician-administered scales. Participants will be eligible for treatment with MM120-ODT-100 micrograms if their HAM-A 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 in response to retreatment and the long-term safety of 120 Key outcomes from Part B will include time to repeated treatment or in efficacy, 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 IIb trial of MM-120inGAD, including using the Ham-A as our primary outcome measure. The primary endpoint for the Phase III program is the change from baseline to week 12, which is consist the durability we observed in Phase IIb. 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. Turning to MM120-ODT for the treatment of MDD. We are excited about the expansion of our pipeline. Data from our Phase II 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 IIb, we observed an 18.7 point improvement from baseline in the Montgomery-Asberg 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. 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 MM-120 as measured by the MADRS. Like the Phase III 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 assets unique 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 MM-120-ODT, subject to certain conditions for treatment eligibility.

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

[Robert Barrow, executive]

Thanks, Dan. Turning to our financial results for the quarter ended September 30, 2024. We ended the quarter with cash and cash equivalents totaling $295.3 million compared to $99.7 million 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 III study of the MIN-120-ODT in GAD. 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 $4 million.

The increase was primarily due to increases of $2.1 million in expenses related to MN120-ODT's advancement into pivotal studies in AD an increase of $0.9 million in expenses related to our 402 program, an increase of $0.6 million in internal personnel costs as a result of increasing research and development capacities and an increase of $0.4 million in expenses related to preclinical activities. We do anticipate R&D expenses to ramp up in 2025 as we get the second Phase III study in GAD in our first Phase III study in MDD up and running. General and administrative expenses were $7.6 million for the quarter ended September 30, 2024, and compared to $8.4 million for the quarter ended September 30, 2023, a decrease of $0.8 million. 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 $13.7 million, compared to $17.9 million for the same period in 2023, a decrease of $4.2 million.

The 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. 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 III studies will drive significant value and we are focused on maintaining our strong track record of execution as we advance our MN-120-ODT Phase III studies and build out the organization with key capabilities for continued success. We believe MM-120-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 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]

[Operator Instructions]

The first question comes from Marc Goodman from Leerink Partners.

[Unknown Analyst]

This is Madhu on the line for Mark. 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 III program could impact central radar unblinding? And is this type of analysis showing lack of central rater and blending something that would be important for approval?

[Robert Barrow, executive]

Yes. Thanks so much for the question. Certainly, the data set we generated in Phase II is going to be an important component of our overall package we're trying 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 II study, the Raiders 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 a pretty uniform distribution across all of the treatment arms. Those data are particularly informative because we had the 5 arms in that study. And so we can look at the 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 blending across all treatment groups, but only 2 of the groups actually respond statistically and clinically significantly. And then from a rate 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 III program.

Those data on functional and blinding, I think as we mentioned during the call, our [indiscernible] extremely common in psychiatry, functional 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 continued 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 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.

[Operator]

Our next question comes from Brian Abrams from RBC Capital Markets.

[Unknown Analyst]

This is Nevin on for Brian. So following some recent commentary from another psychotic 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 they had mentioned some specific issues surrounding finding drapes 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?

[Robert Barrow, executive]

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 II study, the pace at which we were unable to enroll that study in GAD really set the standard for the field and it was faster than we've seen in virtually any other study, and we certainly expect and plan to continue set the standard for the field in that way. I will say we have a very hands-on close engagement with all of our clinical sites.

We certainly have -- there are logistical challenges with the context of these studies, but that's why we have the experts on our team to navigate that and 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 in enrolling the study in Phase II. And so when I continue building on that, as we go forward, again, we have around 30 sites in the VOYAGE study, which is the same size as our Phase II 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's 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 JD and NBD up and running at the same sites in many instances, that gives us a high degree of efficiency so that the patients who are screened for in indication that are, for instance, have a major impressive disorder and made depressive episode could then be moved over into 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 -- and again, every expectation that we'll continue executing as we go forward in the Phase II.

[Operator]

Our next question comes from Charles Duncan from Cantor.

[Charles Duncan, analyst]

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? 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 Ib experience, could you assume a similar time frame for that voyage study to enroll? Or could it pace even more quickly than what you showed in the first go round.

[Robert Barrow, executive]

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 2026. And for the other 2 Phase III studies would be in the second half of 2026. 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 I think the team is doing an incredible job of getting these sites up and running, and hopefully are excited about the enthusiasm we see both from potential participants in the study, but also the investigative sites in particular. 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.

[Charles Duncan, analyst]

If I heard Dan correctly, he mentioned that there was an interim an interim analysis that would be useful for conditional power for using an adaptive design, what triggers that interim analysis? Could you give us a sense of the number of patients? some other milestone.

[Robert Barrow, executive]

At a really high level, I'd 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 time line. So we roll about half of the participants would be a reasonable time to take a look in a blinded fashion, conduct the blinded sample size reestimation 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.

[Charles Duncan, analyst]

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

[Robert Barrow, executive]

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

[Daniel Karlin, executive]

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 erotypic details, certainly, including treatment history treatment as 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 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 a 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.

[Charles Duncan, analyst]

Or any of those phenotypic details, drivers to call it efficacy or even enrollment in the Phase IIb?

[Daniel Karlin, executive]

You'll recall that the $40 per arm design of the Phase IIb pretty small on a per arm basis. So while we can't of course, we slice and base 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.

[Operator]

Next question comes from Francois Brisebois from Oppenheimer.

[François Brisebois, analyst]

I was just wondering, is there 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? And then I have a follow-up.

[Robert Barrow, executive]

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 an individual patient basis and 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.

[François Brisebois, analyst]

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 blind it is this where -- can you 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?

[Robert Barrow, executive]

Thanks for the question No, the blinded interim reestimation of 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 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. -- is 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 during a virtual test at that time.

[François Brisebois, analyst]

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?

[Robert Barrow, executive]

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 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 in a really broad enthusiasm for the potential that this could represent.

[Operator]

[Operator Instructions]

Our next question. Our next question comes from Patrick Trucchio from H.C. Wainwright.

[Patrick Trucchio, analyst]

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

[Robert Barrow, executive]

Yes. On that latter point, I'll just say that we certainly anticipate doing 2 studies. We always will look for opportunities to accelerate our programs, but we'll certainly have plans in place and what will be exploring further the timing and the 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 for that indication. So as that unfolds and as we get clarity on the exact timing and design of that study, we'll certainly be announcing that 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 II study. We want to demonstrate consistency and 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 II. And we want to see a consistent response we ideally see continued response to MM120. And to the extent we see really promising results from our first Phase III, certainly we'll continue to build our confidence in the repeatability of that.

[Patrick Trucchio, analyst]

Right. And then if I could, just a follow-up question on the functional 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, 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?

[Robert Barrow, executive]

Yes. So I think the functional unblinding coming functional and blinding 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 drug 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 question comprehensively across the full program, but also within individual studies.

What we established with statistical and clinical significance in the Phase II study was that we have a dose response and that dose response indicated moving forward with 100-microgram dose, which we're taking into Phase III. We also saw that the pairwise comparison has demonstrated significance the 100-microgram versus placebo. So we're very confident that we have rigorously establish the dose response of the new 120. As we go forward, the lower dose being used in Panorama or second Phase III study getting a little background there, but lower dose being used as a secondary control in Panorama is really intended to confuse someone to entering the study may have an expectancy but by knowing that the lower dose is there, that dose is clearly perceivable, but we've shown in Phase II is clinically not active, would mitigate connectivity between it and the expectancy bias and this clinical outcomes, which is mediated by functional unblinding.

And so doing it, it aims to increase the integrity the view, again, across the program. Now we've already done that in Phase II. So there, again, we feel highly confident that based on the Phase II data, we are seeing a response that is not simply driven by functional and binding at the end of the day, have 3 studies with different allocation ratios and different controls that seek to do 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.

[Operator]

Our next question comes from Jason McCarthy from Maxim Group.

[Michael Okunewitch, analyst]

This is Michael Okunewitch. So I guess just one for me, I'd like to ask a little bit with Compass' data delay, -- 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 MM-20 to drive that expansion of the delivery infrastructure.

[Robert Barrow, executive]

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 in the clinical development programs that our team's ability to against 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 of the key stakeholders and to again set the standard for the field.

[Michael Okunewitch, analyst]

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

[Robert Barrow, executive]

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 the delivery modality, what we are pursuing and how we deliver MM-120 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.

[Operator]

Our next question comes from Sumant Calian from Canaccord Genuity.

[Sumant Kulkarni, analyst]

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 an 120 versus other medications that might be used?

[Robert Barrow, executive]

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

[Daniel Karlin, executive]

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

[Sumant Kulkarni, analyst]

Got it. And then in the -- I guess, if you want to map this out to the real world, what level of rescue therapy that does not involve redosing with 120 if any, might be considered to be optimal in a clinical trial setting.

[Daniel Karlin, executive]

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

[Sumant Kulkarni, analyst]

Yes, exactly. That and how many of those kinds of events would you expect? Clearly, there's always going to be some responders, nonresponders out of that. But if someone does respond and then needs rescue, how do you characterize all that?

[Daniel Karlin, executive]

Yes. So the upshot of that part, the extension phases that if somehow and subsequently loses response, they can get up to 4 open-label treatments during that 40-week period. So the first step would be would be redosing and things that, that captures and people. Well, there are any trial going to be people who don't respond, right? It's no matter how good your drug is, it doesn't treat everybody and it doesn't treat everybody completely particulars are not responding and ultimately are comfortable and have the illness that's severe enough that they need to try something else. Then they are withdrawn from the study and use statistical methods to for the missing data after they need 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 folks are able to stay in the whole study.

[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.