Q1 2025 Mind Medicine (MindMed) Inc Earnings Call
Unknown Speaker 00.00.00.00.
Unknown Executive, Robert Barrow
Speaker Change: I'd like to introduce Stephanie Pagan Chief Corporate Affairs Officer of mine MIT. Please.
Speaker Change: Please go ahead.
Sanders Student: Okay.
Speaker Change: Thank you operator, and good morning, everyone. Thank you for joining us today for a discussion of mind that first quarter 2025 business highlights and financial results.
Sanders Student: Leading the call today will be Rob burrow, our chief Executive Officer.
Rob Burrow: He will be joined by Matt Wiley, our Chief commercial officer and Dr. Dan Carlin, our Chief Medical Officer.
Sanders Student: After our prepared remarks, we will open the call for Q&A.
Sanders Student: 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.
Sanders Student: During today's call, we will be making certain forward looking statements, including without limitation statements about the potential safety.
Sanders Student: The coffee and regulatory and clinical progress of our product candidates.
Sanders Student: Our anticipated cash runway and future expectations plans partnerships and prospects.
Sanders Student: These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development and regulatory approval processes.
Sanders Student: These and other risk factors are described in our filings made with the SEC and the applicable Canadian Securities regulators, including our annual report on Form 10-K, and our Form 10-Q being filed today.
Sanders Student: 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 our filings made with the SEC and the applicable Canadian securities regulators or other significant events occurring outside of mine, that's normal course of business.
Sanders Student: You are cautioned not to place undue reliance on these forward looking statements, which are made as of today may eight 2025.
Sanders Student: <unk> disclaims any obligation to update such statements, even if management's views change except as required by law.
Rob Burrow: With that let me turn the call over to Rob.
Rob Burrow: Thank you, Stephanie and everyone for joining our call today.
Rob Burrow: Before we dive into our business updates and financial results I want to acknowledge that may is mental health awareness month, something that is deeply important to us.
Rob Burrow: This is the time to recognize the millions of individuals around the world who are affected by mental health disorders, including generalized anxiety disorder or J D.
Rob Burrow: A major depressive disorder or M D D.
Rob Burrow: In mind that our mission to transform the treatment of brain health disorders is closely aligned with the goals of mental health awareness month.
Rob Burrow: This month, we stand with others working to address the significant challenges faced by those studying with mental health conditions.
Rob Burrow: As we continue to advance our clinical programs and deliver on key milestones. We also recognize the vital contributions with the broader community.
Rob Burrow: And the investigators leading our trials to the patients who participate in the many advocates driving awareness in progress each plays a crucial role in shaping our future where mental health is treated with the urgency and innovation it deserves.
Rob Burrow: The mental health crisis underscores the need for novel therapies like and then 120, our lead program for the potential treatment of JD and NTT.
Rob Burrow: Three of our pivotal phase III trials evaluating <unk> 120, ODT in patients with <unk> and D. D voyage Panorama and emerge are now actively enrolling and we're seeing strong engagement from clinical sites and patients as momentum continues to build.
Rob Burrow: We're on track to report topline data from voyage in the first half of 2026 with Panorama and emerge to follow in the second half.
Rob Burrow: With breakthrough therapy designation for <unk>, 120, <unk>, a well defined regulatory strategy.
Rob Burrow: Just in execution across our programs, we are delivering against our strategic objectives.
Rob Burrow: We believe in 100000 ODT has the potential to become a differentiated best in class treatment for <unk> MTT addressing a significant unmet need for over 50 million people in the U S alone.
Rob Burrow: Our focus remains on driving this innovation forward and positioning the company for long term value creation as we move towards commercialization.
Rob Burrow: With three of our pivotal trials now underway and enrollment progressing.
Rob Burrow: You need to generate evidence to support 20, odt's potential and highlight its tremendous commercial opportunity.
Rob Burrow: To lead this effort, we recently welcomed our new Chief commercial officer, Matt Wiley to our team.
Rob Burrow: That is uniquely positioned to lead our commercial strategy. During this critical growth phase.
Rob Burrow: He has more than 25 years of experience, having successfully driven the commercialization of innovative therapies with a focus on CNS and psychiatry.
Rob Burrow: He is guided products from development to market launch and accelerated the growth in line marketed therapies.
Rob Burrow: His expertise and insights bring tremendous value to our team and we couldnt be more excited about having him on board at such a pivotal time.
Matt Wiley: With that I'd like to turn the call over to Matt. So he can formally introduce himself.
Matt Wiley: Good morning, everyone and thank you Rob for the introduction it's.
Matt Wiley: It's an exciting time to be at my math I joined this team because what we're doing here isn't just incremental but something potentially transformational.
Matt Wiley: The data from our phase <unk> trial of <unk> hundred 20, and Tid is among the most compelling athene in neuroscience and the disciplined approach behind it speaks volumes about this company's talent.
Matt Wiley: Now that I'm inside the organization my conviction is even stronger and then 120 could redefine the treatment paradigm for JD and MBA and we're moving with urgency to build a commercial engine that matches, the ambition and rigor of our science.
Matt Wiley: Over the past 25 years I've led commercial strategies for multiple breakthrough therapies in psychiatry and CNS.
Matt Wiley: Navigating complex regulatory environments and secured market access and some of the most competitive mark.
Matt Wiley: I have helped companies successfully manage critical product transitions from late stage development through launch and beyond.
Matt Wiley: And I have built commercial organizations from the ground up that our patient focused science, driven and launch ready.
Matt Wiley: What we're building here at mind met is no exception I believe that we're laying the foundation for both the successful launch and for lapping leadership in this space.
Matt Wiley: Every element of our strategy is intended to reflect the same high standards and determination. The company has shown in clinical development.
Matt Wiley: Thank you again to Rob and to the rest of the team for their warm welcome.
Matt Wiley: I'm honored to be here and looking forward to what we can achieve together.
Matt Wiley: And I am excited to share more about our progress in the months ahead.
Dan: I'll now turn the call over to Dan for an update on our clinical programs.
Dan: Thank you, Matt it's great to have you with us.
Speaker Change: As Rob mentioned, we have dose participant in three of our pivotal phase III clinical studies voyage in Panorama evaluating and then 120 <unk> ODT in G H.
Speaker Change: And emerge evaluating <unk> 120, ODT in MDT.
Speaker Change: Starting with wage and Panorama, we remain highly encouraged by the pace of enrollment patients and providers continue to show enthusiasm and high levels of engagement. We remain on track and continue to expect top line Readouts from voyage in the first half of 2026 and Panorama in the second half of 2026.
Speaker Change: As a reminder, each study consists of two parts part a a 12 week randomized double blind placebo controlled parallel group study assessing the efficacy and safety of <unk> 120 versus placebo in part B, a 40 week extension period with opportunities open up.
Speaker Change: <unk> treatment designed to provide important long term data on the durability and response patterns with <unk> 120.
Speaker Change: In voyage, we expect to enroll approximately 200 participants who will be randomized one to one to receive <unk> 120, <unk> ODT 100, micrograms or placebo, while in Panorama, we expect to enroll approximately 250 participants who will be randomized two to one to two to receive <unk>.
Speaker Change: <unk> ODT 100, micrograms, 50 micrograms or placebo.
Speaker Change: In both design and execution, we closely model in our phase III <unk> studies after our successful phase <unk> study of <unk> in both wage and Panorama. The primary endpoint is the change from baseline to week 12 in the half.
Speaker Change: EMEA scale, which was the outcome measure used for the approval of currently available therapies.
Speaker Change: We designed these trials to have 90% power to detect a five point improvement over placebo based on certain statistical assumptions, whereas in the phase II B trial, we observed an almost eight point improvement per and then 120 over placebo at week 12.
Speaker Change: To ensure our actual statistical power is maintained we are using an adaptive design in our <unk> phase III studies, which includes an interim blinded sample size re estimation that allows for increased enrollment of up to 50% in each trial if necessary.
Speaker Change: This approach helps to adjust for any unexpected variability a nuisance parameters, specifically dropout rate and proved variance of handmade response, maintaining statistical power and enhancing the interpret ability of our result if needed.
Speaker Change: We've kept our inclusion and exclusion criteria consistent with our successful phase <unk> study of mm 120, and ghd incorporating exclusion criteria around the recency and total use of psychedelic to ensure a representative sample is recruiting well.
Speaker Change: We also conducted comprehensive safety assessments and labs before and after the administration of <unk> 120, and ensure the collection of all adverse events.
Speaker Change: Turning to our <unk> program with <unk>, we are thrilled to have dosed, our first participant in the pivotal phase III emerge trial and are encouraged by early enrollment trends.
Speaker Change: Just like our <unk> program, our <unk> program will consist of two pivotal clinical studies. Our first study emerge will be comprised of two parts part a 12 week randomized double blind placebo controlled parallel group study assessing the efficacy and safety of a single dose.
Speaker Change: Mmm <unk> ODT versus placebo in part B of 40 week extension period during which participants will be eligible for open label treatment with Min 120 subject to meeting eligibility requirements in.
Speaker Change: In emerge we plan to enroll at least 140 participants with a primary diagnosis of Mgd randomized one to one to receive and then 120, ODP 100 micrograms or placebo.
Speaker Change: The primary endpoint in emerge is the change from baseline in Montgomery, Aspen Depression rating scale or <unk> at week six between the groups. We continue to anticipate top line data from emerge in the second half of 2026.
Speaker Change: Overall, we are excited to add three pivotal trials actively recruiting with all three readouts anticipated next year with that I will turn the call over to Rob to discuss our first quarter financial results.
Speaker Change: Yep.
Rob Burrow: Thanks, Dan.
Speaker Change: Turning to our financial results for the quarter ended March 31, 2025, we ended the quarter with cash cash equivalents and investments totaling $245 $5 million.
Speaker Change: We believe that our cash cash equivalents and investments as of March 31, 2025 will be sufficient to fund our operations into 2027.
Speaker Change: Overall based on our current operating plan and anticipated R&D milestones, we expect our cash runway to extend at least 12 months beyond our first phase III top line data readout, and then 100000 ODT and ghd.
Speaker Change: In April we amended our loan agreement with K, two health ventures to provide greater financial flexibility and Optionality.
Speaker Change: The revised facility provides us with access of up to $120 million based.
Speaker Change: Based on the achievement of certain milestones and extend the interest only period through at least May one 2027.
Speaker Change: The company received approximately $17 $8 million and net cash at closing after refinancing in full all term loans outstanding under the original agreement and the payment of fees and expenses in connection with the amendment and the refinancing of the existing term loans.
Speaker Change: Research and development expenses were $23 $4 million for the three months ended March 31, 2025, compared to $11 $7 million for the three months ended March 31, 2024, an increase of $11 7 million.
Speaker Change: The increase was primarily due to $9 $4 million in expenses related to our it and then 120 program an increase of $2 $4 million and internal personnel costs as a result of increasing research and development capacities and.
Speaker Change: And an increase of <unk> $1 million in preclinical and other program expenses, partially offset by a decrease of zero point $2 million and 402 program expenses.
Speaker Change: We anticipate R&D expenses will continue to ramp up in 2025 due to the costs associated with running three pivotal phase III studies.
General and administrative expenses were $8 8 million for the three months ended March 31, 2025, compared to $10 5 million for the three months ended March 31, 2024, a decrease of $1 7 million.
Speaker Change: The decrease was primarily attributable to stock based compensation expense.
Speaker Change: To close this is an exciting and pivotal time for mine that.
Speaker Change: Our three phase III trials, and then 120 <unk> ODT are active and the enthusiasm from our clinical sites speaks volumes about the need for and promise off and then 120.
Speaker Change: We are energized aligned and confident in where we're headed.
Speaker Change: With breakthrough therapy designation for <unk> hundred 20 <unk>.
Speaker Change: A clear regulatory strategy and consistent execution across our pipeline.
Speaker Change: We are delivering on our mission and driving meaningful value for patients physicians and shareholders alike.
Speaker Change: Thank you for being with us on the call today and the team and I are now happy to answer your questions.
Speaker Change: Certainly ladies and gentlemen to ask a question at this time. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Speaker Change: One moment please for our first question.
Speaker Change: And our first question comes from the line of Marc Goodman with Leerink partners.
Speaker Change: Okay.
Speaker Change: Hi, Good morning, Thank you for taking our question.
Speaker Change: We have a question regarding the <unk> trial would you. Please remind us again, whether you told me to assess the low dose of five microgram.
Speaker Change: In this trial or maybe in the second phase two trial that you're planning to start and regarding the therapeutic effective dose.
Speaker Change: Is it fair to assume that the same therapeutic dose.
Speaker Change: Which is the 100 microgram will also be.
Speaker Change: MDT effected in MTBE.
Speaker Change: Sam.
Speaker Change: That's your question.
Speaker Change: Perfect. Thanks, so much plasma.
Dan: Turn it over to Dan to answer that one yes. Thanks, so much for the question. So as you noted in our second <unk> study, we're using that 50 microgram intermediate blinding controllers and in our disclosed MDT study, we are not using an intermediate dose we're using a two arm study so 100 micro.
Dan: <unk> versus placebo as we've done in our first GAA.
Dan: Study, but it's reasonable to think that at some point in the MDT development program as we as we move into any additional required studies that we might use that same 50 microgram intermediate.
Dan: <unk> control arm. So so while we haven't disclosed the plan to do so it's not unreasonable to think that at some point in the <unk> program and we would do a similar binding neutral as we've done in <unk>.
Dan: With regard to the.
Dan: Therapeutic dose that we would bring forward an M. D D. But we have disclosed is that we'll be using that same 100 microgram.
Dan: Active arm, which we have reason to believe from our GH day results in phase two b.
Dan: It has high efficacy against depression cluster symptoms. So yes, that's what we're using in our disclosed program and reasonable to think that that's what we'll continue to use moving forward Diageo microgram arm.
Speaker Change: Thank you very much very helpful.
Dan: Okay.
Dan: Thank you.
Speaker Change: And our next question comes from the line of Brian Abrams with RBC capital markets.
Dan: Hey, guys.
Dan: Thanks for taking our questions congrats on the progress.
Speaker Change: Matt welcome to the team.
Speaker Change: Just curious as the trial enrollment really gets going.
Speaker Change: Is there any kind of learnings that you are taking away initially from JD epidemiology or treatment patterns disease recognition provider engagement that sort of thing.
Speaker Change: And any any surprises so far and kind of how that is shaping your overall commercial approach and then I guess I'm also curious then kind of following up on the prior question on how the like your latest views on how the low dose might might play and if youre seeing any kind of.
Speaker Change: Evolution.
Speaker Change: Regulatory perspective.
Speaker Change: What you might be looking for out of the 50 microgram dose for either indication.
Speaker Change: Does it does it need to look less efficacious than the 100 or kind of what happens with those.
Showing no efficacy there or comparable efficacy.
Brian: Yes, thanks, so much for the question Brian.
Speaker Change: In reverse order and I'll ask Dan to answer the second one.
Dan: I think.
Dan: With regard to the 50 microgram dose again theres been a lot of discussion about.
Dan: Various controls used and cros.
Dan: Drugs that are under development in this in this category.
Dan: And we made the decision to include a 15 microgram dose group to answer some of those questions. So the metallurgical.
Dan: Asks from FDA.
Dan: It is really important for everyone to understand that.
Dan: That dose level tells us nothing about the performance of the clinical dose of interests.
Dan: As with any program, we are looking at a dose of drug in our case 100, micrograms and 120 versus placebo and while we've included the 50 microgram dose level. It's there so that patients coming into the trial will not be able to draw a degree of certainty between feeling something on the day of dosing.
Dan: And what I expect to see they might have come into the study that wouldnt bias the ultimate clinical outcome assessments. So while we are measuring the response in the activity in the 50 microgram dose group.
Speaker Change: Does it can provide no logical or statistical learnings about the.
Speaker Change: The performance of 100 micrograms versus placebo is really irrelevant to.
Speaker Change: The findings from the study both statistically and what we would interpret clinically.
Speaker Change: Now there are none.
Speaker Change: There are scenarios that could play out and.
Speaker Change: We're certainly very keen on understanding those but we've already looked at.
Speaker Change: Really the first and only study and the classic look comprehensively at a dose response that we've established the minimum clinically effective dose out at several months. After a single administration. So we feel incredibly confident in the dose selection and the justification for that dosing thinking that it would be somewhat illogical.
Speaker Change: Then throw away the evidence we've generated so far which is so compelling.
Speaker Change: In a study where we have a second methodological control. So we're just simply focus on the 100 micrograms versus placebo and include that second dose level again, just to aid and.
Speaker Change: Sort of confounding of patients that they may not be able to know uncertainty because they felt something like they are dosing that they got a real clinically active dose of drug.
Dan: Turn over to Dan to answer the other part of your question yes.
Speaker Change: Brian It's a great question about <unk>.
Dan: <unk>.
Dan: <unk> and change over time for.
Dan: For us of course, having run through the phase <unk> and <unk>.
Dan: No.
Dan: Which was not not something most of done right. There havent been <unk> approvals in 20 years and so it would be running sponsored research and we've of course, we learned a lot about how to find patients had to recruit them how to get the right folks into the study so for us and the sites we work with.
Of course learnings from phase II, we brought forward into phase III here.
Dan: I think there is a broader perspective in that you mentioned the epidemiology of the illness.
Dan: And what we've found just in the time since we started working on <unk> is that there is clearly broader awareness and attention to the disorder. Just in the time that we've been working on it so.
Dan: Over time as more people see anxiety as.
Dan: An issue for themselves is something Thats worth seeking clinical attention that's worth seeking out clinical trials I think were only benefitting from that the pendulum swing back in the direction of <unk>.
Dan: From where it's been sort of pinned over the last 20 years on MDT.
Dan: People are more and more willing to talk about it and think about anxiety as a source of distress in their lives. So so all of that to change both on an hour level and on and really what we're seeing in the sort of systematic societal level is all working in favor of of both the disorder.
Dan: Clinical research and ultimately if approved as a commercial target.
Dan: Super helpful. Thanks, Dan and thanks, Rob.
Dan: Thank you.
Speaker Change: And our next question comes from the line of Gavin Clark Gardner with Evercore ISI.
Speaker Change: Hi, This is Shawn for Gavin Thanks for taking our question just a more general one from US given the recent change of an updated leadership could you maybe speak to how engagement has been going with the agency over the course of the year. Thank you.
Speaker Change: Yes. Thanks, so much for the question yes.
Speaker Change: We obviously.
Speaker Change: We're very much aware and have been a lot of headlines about changes at HHS and at FDA.
Speaker Change: So far our engagement has stayed strong FDA has been incredible partner throughout our development program and Thats all I continue.
Speaker Change: We've continued to have strong engagement and timely responses on any sort of.
Speaker Change: Correspondence with the agency. So we're not seeing any direct impact at this point and are really encouraged by the dialogue we continue to have.
Speaker Change: Thanks, so much.
Speaker Change: Yeah.
Thank you.
Speaker Change: Our next question comes from the line of Charles Duncan with Cantor.
Tim: Hi, Good morning. This is Tim on for Charles Thank you for taking our questions.
Tim: It's great to hear that enrollment is on track for the Canadian MPD trials, but what our steps that you're taking to limit enrolled.
Tim: Enrolling professional patients in need.
Tim: Maintaining the same robust effect size that you've seen in the phase <unk> trial.
Tim: I have a quick follow up.
Tim: Yes.
Tim: At the highest level.
Tim: Everything about how we've designed and are executing the phase III program is consistent with what we did in phase II. So obviously, we as we progress through development, we have incremental learnings to make ourselves more efficient.
Tim: To make sure we're getting the right patients into these studies.
Dan: I'll turn it over Dan to.
Dan: To elaborate a little bit on patient selection.
Dan: Yes, so from a patient selection perspective, and an enrollment perspective.
Dan: Several confirmatory steps as we enroll folks so we look at records from outside Treaters, we have a confirmatory interview called the safer that's done by a third party later, so each step through the screening process and ultimately leading up to enrollment is really oriented around ensuring.
Dan: Strict adherence to protocol in the inclusion exclusion criteria and screening out folks who might be enrolling for reasons other than.
Dan: Trial participation as it is intended to be so we're confident in our sites, we have close relationships with their sites and ultimately it really does come down to two the intersection between high quality sites, who are who are in it to get the right patients and good external confirmation to ensure that that the folks we get are the folks we had.
Dan: Intended to.
Dan: Okay.
Dan: That's really helpful and.
Dan: While the risk for suicidology is not as high as it is and Canadian MTBE Firstly.
Dan: Chemo resistant depression, but what are the steps that you're taking to monitor and prevent the safety risk.
Dan: Yes from enrollment through trial completion, we're of course very attuned to Suicidality in.
Dan: Any treatment in psychiatry and in truth to any treatment and medicine.
Dan: There's always the risk for suicide thinking and even suicidal behavior and of course, that's something that's been.
Dan: Appropriately.
Dan: Pay attention to and our field from.
Dan: From screening on we conduct the industry standard Columbia suicide severity rating scale csrs to ensure that patients we enrolled are safe too.
Dan: <unk> enrolled that anyone who is actively suicidal should be getting care thats not.
Dan: Research based carrier Thats true clinical care, so we're able to refer people back into clinical care system. When they present their they're too ill to participate and then throughout the trial, we continue to monitor both through.
Dan: Of course.
Dan: Adverse event reporting, but also through a serial csrs's and clinical assessments to ensure that if there is a suicide signal that we're able to detect it and respond appropriately cautious in our phase II, we did not see associated signal, which we were.
Dan: Really glad to see of course for the treatment and for the for the disease State population. So we'll just continue to do what we've done and make sure. We're enrolling appropriate patients in that were monitoring them through the course of treatment appropriately. So that both we can ensure participants safety and that we can have a good <unk>.
Dan: Good ability to report out on our safety signals, but at the end of the trials.
Dan: Very helpful answers. Thank you.
Lynn: Thanks Lynn.
Speaker Change: Thank you and our next question comes from the line of Joel Beatty with Baird.
Joel Beatty: Good morning. Thanks.
Speaker Change: Thanks for taking our question this is Chris on for Joel.
Speaker Change: Congrats on the progress.
Speaker Change: And we're looking forward to data in.
Speaker Change: Some some feedback from investors, though is <unk>.
Speaker Change: 25 is a little light on catalysts.
Speaker Change: Wondering.
Speaker Change: If there is any plan to totally thing any interim data between now and the final Readouts and then just another question quick question on <unk>. If you can provide.
Speaker Change: Any color on the next steps in terms of in terms of that thanks.
Speaker Change: Yes, thanks, so much for the question.
Speaker Change: We.
Speaker Change: Our laser focus on executing these studies.
Speaker Change: In the past and continue to set the set the standard for the pace in which we're executing on them in.
Speaker Change: With the Readouts coming next year, we're incredibly eager to get these data out there as quickly as possible.
Speaker Change: We do have a blinded sample size re estimation that is going to occur. Although we haven't provided any any guidance around whether or if or when we would announce any findings from that analysis.
Speaker Change: And beyond that we certainly don't have an anticipation that we would be.
Analyzing releasing any unblinded data that would be informative about extra treatment effect.
Speaker Change: Of course of this year so.
Speaker Change: We're focused on getting the data as quickly as possible and get the highest quality study results.
Speaker Change: In terms of 402, we completed the phase one study we are continuing to develop that program and we will be sharing some additional details.
Speaker Change: The appropriate time about what comes back to that development program and starting to think about how we can get the program progressing patients.
Speaker Change: Diagnosed with autism spectrum disorder.
Rob Burrow: Thanks, Rob helpful.
Speaker Change: Thank you and our next question comes from the line of Rudy Li with Chardan.
Rudy Li: Hey, Thanks for taking my question.
Rudy Li: I'm just curious about your current thoughts on the market dynamics. So thank you Danny.
Rudy Li: In the current environment, given the <unk> growth trajectory and can you talk about your commercial planning activities moving into second half of the year. Thanks.
Matt Wiley: Hi, Thanks for the question this is Matt.
Matt Wiley: So first of all both populations for JD and MPD are quite large there are significant unmet needs in both so.
Matt Wiley: So we feel really confident about.
Matt Wiley: How were planning into the second half of the year and how we're going to address these unmet needs.
Matt Wiley: First of all I'll take on JD, I mean, theres no shortage of JV patients as a durable market and even though it's been <unk>.
Matt Wiley: For some time.
Matt Wiley: We've seen in claims data is diagnosis rates that have been pretty consistent over time. So this is a disease that is.
Matt Wiley: Is recognizable by clinicians the diagnosis diagnoses are made.
Matt Wiley: There is.
Matt Wiley: Some some interesting work to do.
Matt Wiley: How we frame our market and so as we think about our positioning and messaging.
Matt Wiley: We intend to complete.
Matt Wiley: Complete that work and roll that out in the second half of the year.
Matt Wiley: And that will help the market better understand the opportunity for a drug like <unk> 120.
Matt Wiley: Just a quick follow up.
Matt Wiley: Well be planning to just lower rates.
Speaker Change: Commercial infrastructure.
Speaker Change: Two leveraging on the commercial success of <unk>.
Speaker Change: So it's.
Speaker Change: As we think about <unk> as a surrogate it does provide a an interesting opportunity to examine their reimbursement structure. How it would be the capacity is utilized capacity exists beyond to provide patients.
Speaker Change: But as a market itself, we think about JV in a slightly different way, but b J D patients maybe in slightly different locations than where the <unk> patients are there could be overlap.
Speaker Change: But we believe that there'll be a phenotype of physician that has adopted <unk>.
Speaker Change: That could also be adopters for am 120, and so while there we would expect that there will be some overlap in.
Speaker Change: Capacity utilization, there also could be additional capacity and operational opportunities beyond that.
Speaker Change: And I'll just add one comment on top of that which is that while we're certainly encouraged by the growth and the expansion for <unk> to provide it when we look at the relative data obviously in different populations, but the kind of response, we can generate in patients.
Speaker Change: I think we and everyone we speak to it.
Speaker Change: Encouraged by.
Speaker Change: The quality and both the depth and duration of effect that we can demonstrate so brito is an interesting.
Speaker Change: Roof point, but so far in development.
Speaker Change: Incredibly confident in our data and how it would stack up against that drug and how it would position us to have perhaps even a more expansive opportunity.
Speaker Change: Got it that's very helpful. Thanks.
Speaker Change: Thank you.
Speaker Change: Next question comes from the line of Sumit.
Sumit Kearney: Kearney with Canaccord Genuity.
Sumit Kearney: Good morning. Thanks, Thanks for taking my question. This one is from Matt and I know you provided some details on your rationale for joining the company and I apologize. If this has been asked because I've been hopping between calls, but what specifically in your prior experience with commercializing scheduled products might help your best on setting up <unk> hundred 20 for success and what are the unique challenges associated with it.
Sumit Kearney: <unk> versus the other scheduled products that you might have been involved in commercializing so far.
Speaker Change: Sure. Thanks Ahmad.
Speaker Change: First of all I think that having worked on a couple of products with Rems.
Speaker Change: Historically is going to be helpful and most specifically work out sodium oxidate when I was at jazz.
Speaker Change: Which was schedule one outside of indication.
Speaker Change: There are a lot of.
Speaker Change: Parallels to what we're doing here, so I do think that.
Speaker Change: The <unk> operations and the hub service model be applicable here.
Speaker Change: As it relates to LSD, specifically I think that Theres a lot of education to do.
Speaker Change: <unk> for the market and.
Speaker Change: How to view.
Speaker Change: Both the underlying disease state scientifically and then how a drug like <unk> 120 fits into that disease state it for tid.
Speaker Change: Also for Mbd.
Speaker Change: So more to come on that but I think that reframing scientifically as top order for us.
Speaker Change: Got it thank you.
Speaker Change: Thank you and our next question comes from the line of Jason Mccarthy with Maxim Group.
Speaker Change: Hey, guys. This is Michael <unk> on the line. Thank you so much for taking my questions today.
Speaker Change: Yeah.
Speaker Change: So I guess.
Speaker Change: Maybe directed towards Matt just thinking from a commercial perspective could you talk a little bit about how you think about patient targeting within <unk> just given that this will require more upfront time in the clinic than other therapies do you expect you'll be looking at patients already looking into interventional options like <unk>.
Speaker Change: <unk> provides patients who are on chronic drugs, who may not have satisfied factory efficacy or side effects.
Speaker Change: Even patients untreated, who may be discouraged from taking chronic pharma could you just give me a bit more color on your thoughts.
Speaker Change: Well, we're still early days on targeting.
Speaker Change: We use claims data to identify where the patients are and certainly will examine a lot of different factors that will go into our targeting model that work is ongoing we expect to have better clarity on that in the second half of the year.
Speaker Change: Alright. Thank you and then just one more from me just when thinking about seeking approval in both generalized anxiety and major depressive disorder do you expect there could be some competitive benefit to having evidenced in each indication individually just given the rates of comorbid anxiety and depression.
Speaker Change: Items.
Speaker Change: Yes.
Speaker Change: Maybe I'll ask Dan to comment on this.
Speaker Change: Psychiatrist perspective on this because we've done a lot of work with providers in the field and certainly.
Speaker Change: Danny can give some more color to that.
Speaker Change: Yes.
Speaker Change: We've made the choice clearly that.
Speaker Change: From a regulatory perspective.
Speaker Change: Disorders, though massively overlapping as you note due existence distinct entities and there are certainly patients who were not in that co morbid condition to have one or the other.
Speaker Change: In general.
Speaker Change: Providers are accustomed to making a diagnosis and having a primary target for treatment. So we think that from a provider perspective, having.
Speaker Change: Labor that covers both disorders makes us the go to.
Speaker Change: Wireless whether someone.
Speaker Change: Presents in a major depressive episode or with more dominant.
Speaker Change: <unk> symptoms, having had a depressive episode and passed and therefore qualifying for the major depressive disorder diagnosis. So so clearly we have made the choice and are the experts we talked to.
Speaker Change: With this did that by having the entire waterfront of depression and anxiety covered that we'd become the.
Speaker Change: If approved we can become the sort of go to regardless of the condition and presentation.
Speaker Change: Alright, Thank you I really appreciate that additional clarity.
Speaker Change: Thank you ladies and gentlemen, this does conclude today's program and you may now disconnect.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].