Earnings Call Transcript - DFTX Q1 2024

Operator, Operator

Good day, and thank you for standing by. Welcome to the MindMed Q1 2024 Earnings Conference Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Rob Barrow, CEO of MindMed. Please go ahead.

Rob Barrow, CEO

Thank you, and good afternoon, everyone. Welcome to our first quarter 2024 financial results and corporate update conference call. The press release reporting our financial results is available in the Investors & Media section of our website and our quarterly report on Form 10-Q for the quarter ended March 31, 2024, is being filed today with the Securities and Exchange Commission. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidates, our anticipated cash runway and our future expectations, plans, partnerships and prospects. These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC, including our annual report on Form 10-K and our Form 10-Q being filed today. Forward-looking statements are based on the assumptions, opinions and estimates of management as of the date the statements are made, including the nonoccurrence of the risks and uncertainties that are described in the filings made with the SEC 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, May 8, 2024. MindMed disclaims any obligation to update such statements even if management's views change, except as required by law. Joining me on today's call are Dr. Daniel Karlin, our Chief Medical Officer, and Dr. Francois Lilienthal, our Chief Commercial Officer. Earlier today, we announced the transition of Schond Greenway, who as of May 3, is no longer serving as our Chief Financial Officer. On behalf of the Board and the company, I want to thank Schond for all of his hard work and dedication to our mission over the past two years and wish him the best of luck in his future endeavors. We retained an executive search firm to assist in identifying a new Chief Financial Officer to support the next phase of MindMed's growth and evolution. Moving back to our first quarter results. We are excited to be providing this financial and business update during this important period for MindMed. It has been a fantastic start to the year and a highly productive quarter for MindMed, which was highlighted by positive 12-week data from our Phase IIb clinical trial for MM120 in the treatment of generalized anxiety disorder, or GAD. Alongside the data, we were thrilled to announce that the FDA designated MM120 as a breakthrough therapy in the treatment of GAD. This designation is reserved for therapies that are intended to treat a serious or life-threatening condition, and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. We believe receiving this FDA designation and the positive Phase IIb trial data we shared reinforces MM120's potential as an emerging best-in-class product compared to today's standard of care. On the heels of the MM120 data in March, we completed a successful oversubscribed underwritten offering and concurrent private placement raising approximately $175 million in gross proceeds before deducting transaction fees and other offering-related expenses. Participants in the offering included some of the most respected blue-chip institutional health care investors, which we believe further validates the great work that we have been able to achieve in the past year. Most importantly, this financing puts MindMed in its strongest financial position ever, and we expect that it will fund the company through important development milestones for MM120 and other programs in our pipeline. Finally, we announced several scientific posters and presentations that we have shared at various medical meetings. In April, we presented posters at the European Psychiatric Association's 2024 Congress in Budapest, Hungary, and at the Anxiety and Depression Association of America 2024 Conference in Boston. This month, we presented detailed results at the American Psychiatric Association's 2024 Congress and at the International Society for Pharmacoeconomics and Outcomes Research. These poster presentations cover data from our Phase IIb trial of MM120 in GAD, as well as studies related to the epidemiology and growing burden of GAD, which we believe remains underappreciated. Additionally, our collaborators from University Hospital Basel will be sharing one-year follow-up results from a Phase II investigator-initiated study of lysergide in the treatment of anxiety disorders at the Society of Biological Psychiatry 2024 Annual Meeting being held May 9 through 11 in Austin, Texas. Overall, increasing our visibility at these key scientific meetings represents an important strategic initiative for MindMed in 2024 as we look to expand awareness of our work and build MindMed's profile within the scientific community. Our progress comes at a crucial time with an urgent need for better treatments to address the epidemic of brain health disorders, a situation that has grown significantly worse over the past several years. In our lead indication, GAD, for example, a recent mental health prevalence study that was prepared for the Substance Abuse and Mental Health Services Administration found that 10% of U.S. adults report having symptoms consistent with the GAD diagnosis, making it the second most common mental health disorder among adults 18 to 65 years old. In comparison to historical studies, the prevalence of GAD appears to have tripled in the last two decades alone. Our MM120 program in GAD has seen extraordinary progress over the past year, culminating in the four-week data from our Phase IIb trial that we announced in December 2023, and the subsequent positive 12-week follow-up data that we shared in March. Results have exceeded our target product profile for MM120, demonstrating a significant improvement in all analyzed endpoints for up to 12 weeks after just a single dose and without any additional therapeutic intervention. We believe these results demonstrate the fast-acting and durable clinical activity of MM120 along with a favorable tolerability profile. In the context of currently available therapies for GAD, these data represent a major step forward in a field that has seen practically no innovation in the past 20 years. The Cohen's d standardized effect size of 0.81 in the 100-microgram dose group at 12 weeks is more than double the estimated effect size of the current standards of care for GAD, which are estimated to have effect sizes below 0.4 on average. We believe this result can be wholly attributed to the stand-alone effect of MM120 as the trial was conducted in the absence of any other therapeutic intervention. We also reported results from our MM120 PK bridging trial evaluating the MM120 orally dissolving tablet, or ODT formulation, that delivered upon our clinical aspirations for the new product formulation. The ODT formulation provides numerous benefits, including extending MM120's intellectual property profile as well as product performance benefits such as enhanced bioavailability and increased area under the curve of therapeutic concentrations that further differentiates MM120's clinical profile. Overall, the characteristics of the ODT formulation demonstrated in the PK bridging trial provide what we believe is compelling evidence for its differentiated clinical profile and support our decision to progress the ODT formulation into Phase III development. With this exciting progress, we believe we have successfully achieved the goals of Phase II development for MM120 and expect to advance MM120 into pivotal Phase III clinical trials for GAD. We anticipate having an end-of-Phase II meeting with the FDA in the second quarter of 2024 to align on the scope of our Phase III development program and to initiate our Phase III clinical program in the second half of 2024. Additionally, based on the promising data we have observed for MM120 in indications beyond GAD, such as depression, we are actively evaluating additional clinical indications and believe the overall development program for MM120 may represent the best-in-class treatment for GAD and beyond. As we build momentum in development of MM120, we are also strategically enhancing our focus toward commercial planning. As you may recall from our Analyst Day in March, market research shows strong enthusiasm for MM120 with 74% of surveyed health care practitioners indicating that FDA-approved psychedelic treatments will change their approach to treating anxiety and depression. This positive sentiment aligns with the success of Johnson & Johnson's SPRAVATO, or intranasal esketamine, which is rapidly approaching blockbuster status. SPRAVATO's impact extends beyond its own use case as it has helped pave the way for the interventional psychiatry model. This established model includes well-defined patient care reimbursement pathways, EHRs' documentation processes and logistics infrastructure, all of which we believe can be readily leveraged for MM120, should it be successful in clinical trials and ultimately approved by the FDA and marketed. Our second lead program is MM402, which is the R-enantiomer of MDMA. We believe MM402 holds promise for potential prosocial effects and a favorable tolerability profile versus racemic MDMA or the S-enantiomer. The focus of our MM402 program is to develop a regularly administered product that treats the core symptoms of autism spectrum disorder, or ASD, in particular social communication difficulties. Remarkably, despite the significant and increased prevalence of ASD, there are currently no approved therapies specifically targeted at its core symptoms. With robust preclinical evidence supporting our approach, we initiated our first clinical trial of MM402, a single ascending dose trial in adult healthy volunteers in the fourth quarter of 2023. This Phase I trial is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM402 and will enable further clinical studies to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population. Currently, our collaborators at University Hospital Basel conducted a comparative Phase I pharmacokinetic and pharmacodynamic trial of R- versus racemic MDMA with data anticipated in the second quarter of 2024. We believe that the results from this trial will expand and expedite our understanding of MM402's pharmacological profile as we progress into later-stage clinical development. We'll now turn to our financial results for the quarter ended March 31, 2024. As of March 31, 2024, the company had cash and cash equivalents totaling $252.3 million compared to $99.7 million as of December 31, 2023. We believe that our cash and cash equivalents will be sufficient to fund our operations into 2026 based on our current operating plan. For the quarter ended March 31, 2024, net cash used in operating activities was $16.6 million compared to $13.3 million for the same period in 2023. Research and development expenses were $11.7 million for the quarter ended March 31, 2024, compared to $12.6 million for the same period in 2023, representing a decrease of $0.9 million. This decrease was primarily due to decreases of $0.6 million in expenses related to our MM402 program and a decrease of $0.5 million in expenses related to preclinical activities, partially offset by an increase of $0.3 million in internal personnel costs as a result of increasing research and development capabilities. General and administrative expenses were $10.5 million for the quarter ended March 31, 2024, compared to $8.3 million for the same period in 2023, an increase of $2.2 million. The increase was primarily attributable to increased stock-based compensation expense of $1.1 million and an increase of $0.7 million in personnel-related expenses due to an increase in head count to support the growth of our business. The company's net loss for the quarter ended March 31, 2024, was $54.4 million compared to $24.8 million for the same period in 2023. This increase was primarily due to changes in the fair value of the 2022 U.S. dollar financing warrants of $27.7 million. In conclusion, this is a very exciting time for MindMed. We believe that the data on MM120 in GAD that we shared validates our scientific understanding of MM120's mechanism of action and shows the potential for an emerging best-in-class product profile compared to today's standard of care. We are excited to be on the cusp of moving forward into Phase III with this program, which we currently expect in the second half of the year following our anticipated end-of-Phase II meeting with the FDA. Before concluding our call, I want to extend my sincere appreciation and gratitude for the critical work and unmatched execution that has brought MindMed ever closer to realizing our mission. I would like to thank our highly talented and deeply committed team, our research collaborators and clinical investigator teams, our investors and the many other individuals who have been supportive, including especially our patients and their families. We are working tirelessly to deliver on the therapeutic potential of our pipeline and to transform the treatment landscape for the many individuals living with brain health disorders. With that, I'd like to thank you all again for joining us today, and I'm happy to take any questions.

Operator, Operator

Our first question comes from Rudy Li from Leerink Partners.

Guofang Li (Rudy Li), Analyst

Congrats on the progress. Lykos just announced that the FDA is hosting an advisory committee meeting for its MDMA therapy for PTSD. Can you talk about the implications to MM120? And I'm curious what the key topics are that you're looking at for this advisory committee meeting?

Rob Barrow, CEO

Yes. Thanks so much, Rudy. I'll start it off and invite Dr. Karlin to comment as well. We certainly, as a field and as a company, expected an advisory committee for any first-in-class drug candidate; it's important to draw a clear distinction between the mechanism of action and the way MDMA is administered in Lykos' clinical program for PTSD and the distinct way in which MM120 is being developed and studied. Generally, we would expect there to be an advisory committee for novel treatments such as this. There has been some public commentary trying to read into this, but we feel this was expected to occur. In terms of subject matter, we will be following very closely and looking to understand points of interest for the advisory committee. We've seen reports and commentary on other programs. We intentionally, from day one, designed our program to answer many of the key questions presented in our field, and they are covered in FDA's guidance. We feel very confident that we will continue to demonstrate best-in-class scientific rigor and an approach that addresses those questions. So we'll follow the areas of interest from the advisory committee members and look forward to hopefully a successful outcome for Lykos and MDMA.

Operator, Operator

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

Brian Abrahams, Analyst

At the recent APA presentation, you showed some trends over time in both HAM-A and PGIS, and it looked like directionally they were similar, but maybe there were some subtle differences. Can you talk about that and how that's impacting your base case for the durability of the administration based on this and other evolving data? Secondarily, I think the MADRS change here really underscores what could be a potential antidepressant effect. You alluded to it in the prepared remarks, but what are the factors you'll be considering in determining whether to move forward in major depressive disorder or other depression indications, and how are you thinking about potential indications there?

Rob Barrow, CEO

Perfect. Brian, I'll turn it over to Dan to talk about your first question, then I'll address the second one.

Dr. Daniel Karlin, Chief Medical Officer

Yes, absolutely. Thanks so much for the question. When we look across all of the different measured data that we've shown publicly so far, what we see is directional agreement and, to a very large extent, magnitude agreement as well. Each of these different scales gives us confidence in the different domains they pick up, and that the effect we're seeing is real and not an artifact of one particular scale or one particular method of administering a scale. Of course, a clinician-rated CGI collected by a blinded rater will reflect slightly different things than a PGI that may be more determined by a patient's individual experience. Particularly the fact that we're seeing slight degradation on the PGI at week 12 doesn't give us concerns about the robust activity of the drug, especially since we're seeing such strong significance across the clinician-rated measures. Rob, do you want to speak about the MADRS or should I?

Rob Barrow, CEO

Yes, absolutely. I would just note, too, on that first point, Brian, that the HAM-A scale is the gold standard for anti-anxiety approval. That's where we'll be focused in our dialogue with the FDA. While we talk about pairwise comparisons, you have to remember that this was a large 200-patient study with robust power and statistical conclusions on the HAM-A. The secondary endpoints with around 40 patients per arm in the Phase II study can show numerical changes that would likely be statistically significant in a larger population. In terms of the depression indication, as we have mentioned publicly, we are actively assessing additional indications. In psychiatry there is a strong overlap between depression and anxiety, and given the promise of this drug class and the magnitude of effect we believe we can achieve, looking at major depressive disorder and related indications makes sense. It also makes sense in terms of providing the drug to clinicians to maximize its impact and uptake. We will provide guidance at the right time if and when we determine the exact indication and clinical development plans for any subsequent indications. With the MADRS scores, it's hard to overlook the magnitude of response we've observed and the potential antidepressant effect in our Phase II study, which builds on prior studies showing durable effects in major depressive disorder. There's obviously an opportunity there, and we'll be looking at it closely and will give further guidance in the future.

Operator, Operator

Our next question comes from Charles Duncan from Cantor.

Elaine S. Kim (on for Charles Duncan), Analyst

This is Elaine on for Charles. Going back to your presentation at APA, what feedback did you receive from the KOLs? Was the 12-week durability the most important point? Also, what was the perception towards the improvement in PGIS? I have a follow-up on MM402 as well.

Rob Barrow, CEO

I'll turn it over to Dan to address that one.

Dr. Daniel Karlin, Chief Medical Officer

Thanks, Elaine. We get feedback of all different types and certainly different experts focus on different aspects of efficacy. For clinicians treating people with GAD, the rapidity of effect — the fact that we saw strong clinically significant and statistically significant changes on measurable scales as soon as day two — was particularly notable. Of course, durability is also important and many take those two in combination to say it really does look like we are eliciting a rapid and durable drug effect, which is unlike other tools available. Overall, the data were very warmly received and experts are appropriately excited to see these results.

Elaine S. Kim (on for Charles Duncan), Analyst

And for MM402, pending a favorable PK profile and tolerability from the Phase I trial, what do you envision as the target product profile for MM402 in ASD?

Rob Barrow, CEO

At a high level, with no approved therapies to treat the core symptoms of autism spectrum disorder, the ultimate goal for MM402 is to have a regularly administered treatment that would aid in core social communication deficits in autism. The analogy we often draw is how stimulant medications are used to treat ADHD: while the drug is active, patients are better able to focus and participate in school or work. Different mechanisms and targeting a different disorder notwithstanding, in autism the social communication deficits are the core target for pharmacological intervention, as FDA patient workshops have described. We believe racemic MDMA and potentially R-MDMA could aid in social communication abilities. So the ultimate product profile would be a regularly administered product that improves social communication and allows individuals to more readily participate in daily activities and occupational roles.

Operator, Operator

Our next question comes from Frank Brisebois. This is Dan on for Frank.

Unknown Analyst (Dan on for Frank), Analyst

Firstly, with regard to the planned Phase III, could you give us some color on how you're thinking about the design of that study? Any similarities or differences to the Phase IIb? Specifically, does the Zydis ODT formulation's PK impact the Phase III design at all? Also, one quick follow-up: the new epidemiological data presented at APA — could you talk about the GAD-7 screening tool, how that's potentially being used in the next trials, and any learnings regarding the market opportunity in GAD based on that new data?

Rob Barrow, CEO

In terms of planned Phase III studies, we'll reserve final determination of the protocols until after our end-of-Phase II meeting and we reach alignment with the agency on the pivotal path forward. Given our interactions to date, we feel we have a high degree of understanding of the right approach. By and large, the Phase III clinical trials will be extremely similar, if not virtually identical, to our Phase II clinical trial design, with the exception that we intend to proceed for purposes of statistical comparisons with the 100-microgram ODT versus placebo. The ODT formulation itself has no impact on the Phase III design. We were really encouraged by the PK bridging results. From what we've seen in that study, both quantitatively and qualitatively talking to the investigators, we believe the 100-microgram dose is optimal. We are particularly encouraged about the prospects as we go into the clinical trial, so no impact on study design but higher conviction about the clinical potential of that formulation. On the epidemiological data and GAD-7: we will be using the GAD-7 in the open-label portion of our Phase III program to screen patients for potential retreatment. After our 12-week double-blind period, patients will have the opportunity to roll into a nine-month open-label study where they'll be screened and, if GAD symptoms are present, there will be the opportunity for retreatment. One of the things we've observed in epidemiological and pharmacoeconomic research is that one of the most costly patient populations are those who have GAD symptoms but haven't received a diagnosis and patients with severe disease. The vast majority of patients with GAD have moderate to severe disease partly because current treatments are not well suited to treating anxiety. We'll be looking at the GAD-7 in our Phase III program. Given the underdiagnosis of GAD, we believe the tool will be important in identifying patients in the real world. We think the total opportunity is much larger than current statistics suggest, and we expect screening recommendations to provide a tailwind for uptake.

Unknown Analyst (Dan on for Frank), Analyst

That's helpful. Just one quick one: any additional thoughts on the GAD-7 screening tool and market opportunity?

Dr. Daniel Karlin, Chief Medical Officer

What we learned from the epidemiological work is that this is an underdiagnosed condition. In the study, just over 23% of respondents had a positive screen on the GAD-7, and just over 80% of those had never been diagnosed with GAD. We learned about the health care utilization of these folks who likely have GAD but are undiagnosed. There's a tremendous impact on individual well-being and on health care and employer costs. This adds further evidence in support of the USPSTF recommendation that folks ought to be screened. GAD-7 is essentially the equivalent for anxiety disorders of the PHQ-9 for depressive disorders. PHQ-9 has been used more frequently over the past 20 to 25 years to pick up depressive disorders, and GAD-7 can play that role for anxiety. We are strongly supportive of screening for anxiety disorders in primary care and other settings. The data suggest that many undiagnosed folks tend to be younger, developing anxiety symptoms in their 20s or early 30s and then going many years without a diagnosis. Early screening and intervention can get people treatment earlier before comorbidities and other impacts accumulate.

Operator, Operator

Our next question comes from Sumant Kulkarni from Canaccord Genuity LLC.

Sumant Kulkarni, Analyst

What are your latest thoughts on potentially developing MM120 for depression? Would that be a program the organization could run simultaneously with the pivotal program in GAD and other programs like MM402? Or will you focus on GAD until you get more clarity from the Phase III program?

Rob Barrow, CEO

Thanks, Sumant. We are taking a hard look at the market dynamics and opportunity in depression and related indications. We've built the company over the past three years with the ability to execute on multiple technical development programs. Our infrastructure and team are designed to operationalize multiple programs, so we expect to be in a position to execute on multiple clinical indications potentially in parallel. We will not lose focus on our lead program, MM120 in GAD, which remains the furthest along. But operational efficiencies and overlap exist between indications, so we should be able to pursue other indications such as depression depending on decisions and evidence. We'll give further guidance if and when we decide to launch a second indication for MM120. Regarding the end-of-Phase II meeting with the FDA, I wouldn't want to speculate on where we might differ from the agency. We go into regulatory interactions with a mindset of partnership. We've appreciated the FDA's thoughtful and productive engagement on this drug class over the past several years. There are always nuances in drug development, and we will listen and follow guidance while making logical, scientific arguments where necessary. We view the FDA as a partner and expect constructive dialogue as we go into the Phase II meeting.

Operator, Operator

Our next question comes from Elemer Piros from Rodman.

Elemer Piros, Analyst

Rob, how heavily pretreated was the Phase IIb population? In the commercial setting once approved, where do you see MM120 being used, especially considering the large undiagnosed population? Where would MM120 fit based on your Phase IIb trial and your anticipated Phase III design?

Rob Barrow, CEO

I'll take the commercial positioning first. When we think about where MM120 could fit in the real world, there's been a constraining view that these therapies could only be reserved for the most severe patients who have failed everything else. Our data suggest a different trajectory. In GAD, patients who go undiagnosed or have severe GAD end up spending years with related comorbidities and a huge impact on quality of life and the health care system. The value comes from addressing both undiagnosed patients and those with severe disease. We do not expect to market MM120 necessarily as a first-line therapy, but there is enormous value in focusing on patients with severe disease or prior treatment failures. We also see the potential for benefit in patients earlier in their treatment course given the data. Our clinical trial population is representative of the real-world population, with a significant portion having prior treatments. When we analyze the data by treatment history, we don't see a meaningful difference in response regardless of treatment history, which is encouraging.

Elemer Piros, Analyst

Do you think there's a difference in the patient journey between someone newly diagnosed with primary depression versus GAD? What sort of physicians would each see before they get significant help, if ever?

Dr. Daniel Karlin, Chief Medical Officer

That's a good question about the patient journey. MDD is generally episodic, with periods of depression and periods of normal mood, so people may seek care earlier when they move into a depressed state. GAD can have a more insidious onset, and people may acclimate to this new way of feeling and not see it as something to raise with a clinician. Both conditions often start with primary care. First-line treatments are commonly given in primary care because of limited access to specialty psychiatry. SSRIs are often prescribed at the primary care level for both depression and anxiety. As patients become more severe, treatment-resistant, or have intolerable side effects, they typically enter specialty psychiatric care. These patterns are driven by treatment availability. The availability of different treatments changes care patterns, so we think about both current patient flows and how they could evolve if new treatments like MM120 become available.

Elemer Piros, Analyst

Some people believe psychedelic medicine treatments would only be prescribed by specialists. But prescribers won't be administering these therapies; specialized centers will. Do you agree or disagree?

Dr. Daniel Karlin, Chief Medical Officer

There are parts of that view we agree with and others we would push back on. Who is comfortable prescribing will relate to the data we generate around efficacy and safety, and the assessments we require for prescribing. In many cases, the prescriber and session monitor may not be the same person, and prescribing clinicians may be affiliated with or separate from administration centers. Today, interventional psychiatry is largely centered around specialized centers due to the need for physiological monitoring and medical oversight. We did not see physiological liability in Phase IIb, which may open the possibility that MM120 could be administered in a broader range of settings than highly specialized centers. We are considering a range of options for who could be prescribers and who could be session monitors.

Rob Barrow, CEO

I'll add that it's important to appreciate the scale of the opportunity. Just because current practice for existing treatments often occurs in primary care doesn't mean the same model applies for new interventional therapies. We believe these treatments can transform patient care and medical practice. We want to avoid a model where access is extremely limited and reserved as a last-line option. We see the need for a broader approach to reach more patients and have a meaningful impact.

Elemer Piros, Analyst

One more aspect: specialists spend time managing side effects and titrating medications. We don't have this issue with MM120, do we?

Dr. Daniel Karlin, Chief Medical Officer

That's exactly right.

Rob Barrow, CEO

When we talk to practicing psychiatrists, what they repeatedly appreciate is a drug with a high degree of clinical remission driven by both rapidity and durability. With SSRIs, adverse events occur during the weeks before clinical benefit is expected. With MM120, the rapid response we saw means an early follow-up within a few days is largely indicative of where the patient will be months later. That early clinical clarity is highly desirable for providers and is exciting in our data. And while some patients report a headache the next morning, overall we feel very comfortable with the physiological profile.

Operator, Operator

Next question comes from Patrick Trucchio from H.C. Wainwright & Company.

Patrick Trucchio, Analyst

A couple of follow-ups. First, on the new epidemiological data presented at APA: in terms of potential impact on commercialization of MM120 in GAD, can you talk about the prospects of having the validated GAD-7 screening tool more widely deployed in real-world health care settings as part of commercialization? Second, is this data itself helpful or can it be built upon as part of health economic outcomes research? Could it be beneficial for the potential launch of MM120? Separately, there's some University Hospital Basel data upcoming. Can you give an idea of potential read-through regarding durability from that UHB data being presented at Biological Psychiatry and whether those findings could impact discussions with the FDA regarding the Phase III program? How could that data be helpful? Finally, regarding MM402, can you talk about potential read-through from the UHB Phase I trial to your program and how you think about next steps for MM402 and ASD assuming positive outcomes in your GAD program?

Rob Barrow, CEO

I'll try to take these one by one. On prevalence and GAD-7: while we've emphasized the underdiagnosis of GAD, the fact there is a tool that can validly pick up undiagnosed GAD and that it's being recommended for implementation suggests the market is much larger than current statistics indicate. That has a huge impact from a health and societal perspective and, from a market opportunity perspective, suggests greater potential adoption than current epidemiology alone would suggest. We are actively working on health economics and outcomes research to quantify the scale and scope of the impact we can have and to demonstrate the value proposition to stakeholders needed to enable broad uptake of our products. We have a talented group working on that. Potential read-through of the University Hospital Basel investigator-initiated study: over the past couple of years, there were investigator-initiated data on lysergide with different doses and regimens that demonstrated durable effects out to about six months for patients who received lysergide first. In our Phase II results, we've seen HAM-A scores largely flat-line without regression back to baseline on average over time. If we ultimately see similar durable effects as investigated in investigator-initiated smaller studies, that bodes well for what we may be able to demonstrate in longer follow-up, such as the open-label studies planned for Phase III. Regarding MM402, it's difficult to extrapolate healthy volunteer data into disordered populations. However, the Phase I data will help us understand tolerability, PK and PD profiles. Demonstration of tolerability and pharmacology will be informative as we design further studies, but we won't overextend interpretation of healthy volunteer data when planning Phase II and beyond.

Operator, Operator

I am showing no further questions at this time. That concludes our question-and-answer session. Thank you for your participation in today's conference. This concludes our program. You may now disconnect.