Q3 2025 Mind Medicine (MindMed) Inc Earnings Call

Speaker #2: Good day and thank you for standing by . Welcome to the mind map . Third quarter earnings conference call and webcast . At this time , all participants are in listen only mode .

Speaker #2: After the speaker's presentation , there will be the question and answer session . To ask a question during the session , you need to press star one one on your telephone keypad .

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Speaker #2: This conference is being recorded . I would now like to hand the conference over to our first speaker today , Geeta Jain , head of IR .

Speaker #2: Please go ahead .

Speaker #3: Thank you . Operator . And good afternoon , everyone . Thank you for joining us today for a discussion of Mimedx third quarter 2025 Business highlights and financial results .

Speaker #3: Leading the call today will be Rob Barrow , our chief Executive Officer . Doctor Dan Karlin , our chief medical officer . And Brandi Roberts , our chief financial officer , are also on the call .

Speaker #3: 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 .

Speaker #3: During today's call , we'll be making certain forward looking statements , including , without limitation , statements about the potential safety , efficacy and regulatory and clinical progress of our product candidates .

Speaker #3: Are 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 .

Speaker #3: These are other . These and other risk factors are described in the filings made with the SEC and the applicable Canadian securities regulators , including our annual Report on Form 10-K and our form 10-q filed today .

Speaker #3: Forward-looking statements are based on assumptions, opinions, and estimates of management at the date the statements are made, including the non-occurrence of the risks and uncertainties that are described in the filings made with the SEC and the applicable Canadian securities regulators, or other significant events occurring outside of the normal course of business.

Speaker #3: You are cautioned not to place undue reliance on these forward looking statements , which are made as of today , November 6th , 2025 .

Speaker #3: Mind Medicine (MindMed) Inc any obligation to update such statements , even if management's views change , except as required by law . With that , let me turn the call over to Rob .

Speaker #4: Thank you . And thank you , everyone for joining our call today . We delivered another solid quarter advancing our clinical programs and continuing to build one of the most robust late stage pipelines in our field .

Speaker #4: In addition , this quarter saw the publication of our full phase two clinical trial results and the Journal of the American Medical Association highlighting the rigor and impact of the clinical results we have generated to date .

Speaker #4: Building on this scientific momentum , we successfully completed an underwritten public offering last week , raising approximately $259 million in gross proceeds . This additional capital further strengthens our balance sheet and enables us to strategically accelerate the development of m120 and M402 .

Speaker #4: We continue to expand and strengthen our investor base while welcoming in new high quality health , dedicated funds and mutual funds . While deepening support from our long term shareholders .

Speaker #4: This financing underscores the strength of our science and positions us for transformational 2026 , a pivotal year ahead with three Top-line phase three data readouts expected between our generalized anxiety disorder , or Gad , and major depressive disorder , or MDD programs .

Speaker #4: Enrollment is strong and steady across our ongoing pivotal studies of M120 . We reiterate our guidance and continue to expect top line results from voyage in the first half of 2026 and Panorama in the second half of 2026 .

Speaker #4: Due to faster than anticipated enrollment in the past quarter . Top line results from the Emerge study are now anticipated in mid 2026 .

Speaker #4: An update from our prior guidance of the second half of 2026. We are also excited to share further details of ASCEND, our second Phase 3 study of 120 patients in MDD, which we expect to initiate in mid-2026.

Speaker #4: We continue to deploy resources and operationalize our programs with remarkable efficiency in pursuit of approvals in both Gad and MDD , two of the most prevalent and burdensome psychiatric disorders .

Speaker #4: Over the course of 2025 , we have continued our constructive dialogue with FDA and believe we are well positioned to deliver on an expeditious path forward in both indications .

Speaker #4: For far too long , patients struggling with anxiety and depression have been significantly underserved by current treatments . Many cycle through multiple therapies with limited success .

Speaker #4: They're looking for something different a safe and effective new treatment option that they feel confident will deliver meaningful change , not just symptom suppression .

Speaker #4: Based on the safety , efficacy , and durability we have demonstrated with m120 OT to date , we believe it has the potential to represent such a transformative option .

Speaker #4: Addressing anxiety and depression through an efficient , patient centered delivery model . It's also important to remember that the results we have generated to date have been achieved with a single dose administered as a monotherapy , without coadministered psychotherapy .

Speaker #4: We believe that m120 OT could integrate well into the existing healthcare infrastructure using well established reimbursement codes covering evaluation , prescribing and monitoring , in addition to the actual treatment itself .

Speaker #4: Our goal is to reduce administrative barriers to adoption and help ensure that providers are appropriately compensated for their time and services . With regard to our additional R&D activities , we are pleased to share an important update on our second asset in the pipeline .

Speaker #4: Mx400 two , or the r-enantiomer of MDMA . Having already completed a single ascending dose . Phase one study of M402 in healthy adult volunteers .

Speaker #4: We plan to initiate a phase two study in participants with autism spectrum disorder , or ASD , by the end of 2025 . We believe ASD represents a significant opportunity with growing prevalence and substantial unmet need as we approach the last few months of 2025 .

Speaker #4: Our team remains laser focused on executing our ongoing studies and laying the groundwork for a transformational 2026 and beyond . Looking ahead , we anticipate three pivotal data readouts of One20 eight for Gad and MDD in 2026 .

Speaker #4: The initiation of our second pivotal study in MDD in 2026 , the advancement of M402 and ASD into a phase two study . By the end of 2025 and further advancement of our go to market strategy as we prepare for the potential launch of Gm1 28 .

Speaker #4: With strong momentum across all fronts , we're working hard to bring transformative treatment options to the many patients needing new alternatives . With that , I'll turn the call over to Dan for an update on our clinical programs .

Speaker #5: Thanks , Rob . We continue to be highly encouraged by the enrollment trends we are seeing across our pivotal phase three studies . As Rob mentioned earlier in Gad , we expect to report voyage results in the first half of 2026 and Panorama results in the second half of 2026 .

Speaker #5: Given the especially strong enrollment in our ongoing MDD study emerge , we are excited to now be in a position to report results from emerge in mid 2026 .

Speaker #5: This quarter , we also saw the publication of our full phase two B trial results in the Journal of the American Medical Association , or Jama .

Speaker #5: It's a big moment , not just for us , but for the entire field of psychiatry . This study represents the most robust randomized , placebo controlled trial of lysergide tartrate , or LSD , in a psychiatric population .

Speaker #5: Using today's modern scientific standards . This trial evaluated a single treatment across four dose levels 25 , 50 , 102 hundred micrograms and demonstrated compelling clinical activity with a statistically significant dose response .

Speaker #5: Our optimal 100 microgram dose showed both rapid and durable effects with a statistically significant 7.7. greater reduction in Hema versus placebo at week 12 .

Speaker #5: Additionally , 65% of patients in the 100 microgram cohort showed clinical response and 48% achieved remission . 12 weeks after the single administration of 120 .

Speaker #5: Moving to our phase three program , our Gad studies each have two parts . Part A a 12 week randomized , double blind , placebo controlled assessment of rm120 versus placebo .

Speaker #5: And part B , a 40 week extension phase with open-label opportunities to evaluate long term durability and response patterns in voyage . We are targeting enrollment of approximately 200 participants who are being randomized , 1 to 1 to M.M.

Speaker #5: , 128 100 micrograms or placebo , while in Panorama , we are targeting enrollment of 250 participants who are being randomized two to 1 to 2 to one , 28 , 100 micrograms , 50 micrograms or placebo .

Speaker #5: These phase three studies are modeled after our successful phase two B study using the Hamilton Anxiety Scale , or Ham-a , as the primary outcome measure .

Speaker #5: This was the outcome measure used for the approval of existing Gad therapies . The primary endpoint in our phase three studies is the ham-a change from baseline to week 12 .

Speaker #5: Building on the success of our phase two B results . Even though we observed a 7.7. placebo adjusted improvement in phase two B , we've designed our phase three trials to have 90% power to detect a five point improvement over placebo .

Speaker #5: We've also designed our phase three trials to address functional unblinding , a topic that is often raised when discussing research methods being used to investigate drugs in the broad psychedelic category .

Speaker #5: Clearly , M120 ODT and other drugs in the category have a distinctive set of perceptual , cognitive , and emotional effects . At the time of administration .

Speaker #5: While the phenomenological nature of these effects is unique to the category , the vast majority of approved psychiatric drugs also have acute effects that result in participant unblinding .

Speaker #5: Even so , in order to maximise the integrity , reliability , interpretability , and generalizability of our research , we have implemented a set of interventions intended to address this and other methodological considerations across our phase two and phase three programs .

Speaker #5: These include using central raters were blinded to both treatment assignment and visit number , incorporating questionnaires to assess potential expectancy bias and unblinding , and in multiple of our studies , including additional control arms that are substantially perceivable by participants but are not of interest in assessments of clinical efficacy .

Speaker #5: Our continued interactions with FDA further support alignment with the rigor and design of our approach , reinforcing our belief that our development strategy can deliver definitive , clear and compelling evidence of the safety and efficacy of Mg120 ODT in Gad and MDD .

Speaker #5: Turning to our MDD program, we are pursuing a similar approach to our GAD program, which includes two pivotal studies following the same two-part design.

Speaker #5: Both of our pivotal MDD studies emerge and Ascend are comprised of two parts . Part A , a 12 week randomized , double blind , placebo controlled , parallel group period assessing the efficacy and safety of a single dose of Mg120 ODT versus placebo , and part B , a 40 week extension period with opportunities for open label treatment .

Speaker #5: The primary endpoint in each study is the change from baseline in the Montgomery-Åsberg Depression Rating Scale, or MADRS. At week six, between May 1st, ODT 100 micrograms and placebo in Emerge.

Speaker #5: We are targeting enrollment of at least 140 participants , randomized 1 to 1 to m 128 100 micrograms or placebo . We now anticipate top data from emerge in mid 2026 .

Speaker #5: In our second pivotal MDD study , ascend , we are targeting enrollment of at least 175 participants , randomized two to 1 to 2 to receive M120 100 micrograms , 50 micrograms , or placebo .

Speaker #5: We expect to initiate ascend in mid 2026 . Moving to our next pipeline candidate . We are excited to share our plans to advance m402 the .

Speaker #5: R-enantiomer of MDMA in preclinical studies , M402 has shown promising prosocial effects with a potentially superior tolerability profile compared to both racemic MDMA and the s-enantiomer of MDMA .

Speaker #5: We're developing M402 to target the core symptoms of autism spectrum disorder , specifically addressing social communication challenges . We believe this program represents another significant treatment opportunity given the high unmet need .

Speaker #5: The increasing prevalence of ASD and no FDA approved therapies that specifically address these core symptoms . Having completed a phase one single ascending dose study that characterized the tolerability , pharmacokinetics , and pharmacodynamics of m402 and healthy adult volunteers , we plan to initiate a phase two study later this year .

Speaker #5: This study will be a single dose open label design assessing early signals of efficacy in up to 20 adult participants with ASD . The objectives and endpoints of this study are designed to characterize the pharmacodynamics and clinical effects of m402 in adults with ASD across multiple functional domains .

Speaker #5: In summary , we are efficiently executing across our pipeline . Our pivotal phase three programs for M120 and Gad and MDD remain on track for data readouts next year , and we plan to initiate ascend , our second phase three MDD trial in mid 2026 .

Speaker #5: As we progress . M120 toward commercialization , we are also excited to advance our M402 program for ASD , furthering our mission to develop breakthrough treatments for underserved patients .

Speaker #5: With that , I'll turn the call over to Brandy to discuss our third quarter financial results . Brandy .

Speaker #6: Thanks , Dan . Turning to our financial results for the quarter ended September 30th , 2025 . We ended the quarter with cash .

Speaker #6: Cash equivalents and investments totaling $209.1 million . As Rob noted earlier , we successfully completed an underwritten public offering last week , raising $258.9 million in gross proceeds after deducting underwriter commissions and expenses .

Speaker #6: Net proceeds are $242.8 million . We're very pleased with the outcome of our recent financing , which puts us in an excellent position for the future .

Speaker #6: We were encouraged by the strong level of high quality investor interest in Mindmed and in our development programs . A clear reflection of the confidence the investment community has in our mission .

Speaker #6: This funding allows us to accelerate key initiatives that will set M-120 up for success , including NDA preparation , state prioritization , efforts for scheduling market research and Kol education , among others .

Speaker #6: These efforts position us well to move quickly in the years ahead , pursuing submission of an NDA for m-120 as soon as possible , and if approved , executing a robust and well prepared commercial launch .

Speaker #6: Based on the company's current operating plan and anticipated R&D milestones , the company believes that its cash , cash equivalents and investments as of September 30th , 2025 , along with the net proceeds from the recent offering , are sufficient to fund the company's operations into 2028 .

Speaker #6: Expenses for the third quarter of 2025 were in line with our internal expectations , as we continue to make significant progress with M-120 and M402 R&D expenses were $31 million for the third quarter of 2025 , compared to $17.2 million for the third quarter of 2020 .

Speaker #6: Four , an increase of $13.8 million . The increase was primarily due to increases of $11.7 million in M-120 program expenses , $2.5 million in internal personnel costs , reflecting expanded research and development capabilities , and $200,000 in preclinical and other program expenses .

Speaker #6: These amounts were partially offset by a $600,000 reduction in M402 program expenses . G&A expenses were $14.7 million for the third quarter of 2025 , compared to $7.6 million for the third quarter of 2020 .

Speaker #6: Four , an increase of $7.1 million . The increase was primarily due to increases of $3 million in personnel related expenses , $2 million in commercial preparedness related expenses , $1.6 million in corporate affairs expenses , and $500,000 in other miscellaneous administrative expenses .

Speaker #6: Net loss for the third quarter of 2025 was $67.3 million , compared to $13.7 million for the same period in 2020 . Four .

Speaker #6: Note that our net loss can be impacted dramatically by the changes in the fair value of our 2,022 USD financing warrants from quarter to quarter , as our stock price fluctuates .

Speaker #6: The change in fair value for the third quarter was $22.5 million , as our stock price increased from $6.49 at June 30th , 2025 to $11.79 at September 30th , 2025 .

Speaker #6: I'll also note that warrant exercises related to the 2022 financing have brought in approximately $2.5 million of cash this year , with an additional $17.6 million of potential funding remaining prior to the warrant expirations .

Speaker #6: In 2027 . With that , I'll now turn it back over to Rob for closing remarks .

Speaker #4: Thank you . Brandi . This year has been one of bold ambition and disciplined execution . We're delivering on our programs and actively shaping the future we believe is possible .

Speaker #4: Enrollment remains strong across all three of our ongoing pivotal trials . Voyage , Panorama and Emerge . And we are eager to continue this momentum with the initiation of our second pivotal trial , ascend , in mid 2026 .

Speaker #4: At the same time , we're advancing M402 into a phase two study , a meaningful milestone as we work to bring much needed innovation to the ASD community .

Speaker #4: 2026 is shaping up to be a defining year in our evolution . When where science , purpose , and precision converge to advance the therapeutic potential of 120 and our broader pipeline with a strong balance sheet and a late stage pipeline with multiple catalysts in the year ahead , we're excited to continue driving value for our shareholders in the millions of patients who deserve more than better .

Speaker #4: Of course , none of this progress would be possible without our exceptional team , whose passion and commitment and unmatched execution continue to set the standard for our field .

Speaker #4: Thank you again for joining our call today . We'll now open the line for questions .

Speaker #2: Thank you . Dear participants , as a reminder , if you wish to ask a question , please press star one one on your telephone keypad and wait for your name to be announced .

Speaker #2: To withdraw a question , please press star one and one again . Please stand by while compile the Q&A roster . This will take a few moments .

Speaker #2: And I will go and take our first question and it comes to line of Gavin Clark Gardner from Evercore . Your line is open .

Speaker #2: Please ask your question .

Speaker #3: Hi .

Speaker #7: This is for Gavin . Thank you so much for taking our question . We just had a brief one on the blinded sample size Re-estimation .

Speaker #7: Mostly wondering if this has been completed and if so , given that the trial size expectation is still 200 patients , is it reasonable to assume that the trial is not being upsized ?

Speaker #7: Thank you .

Speaker #4: Thanks so much . Yeah , we haven't disclosed anything about a public disclosure of our sample size . Re-estimation . And and I know you're referring to the ability to increase the sample size to maintain 90% power .

Speaker #4: In both the Voyage and Panorama studies, there are two GAD studies. We are excited about enrollment and on track for our readouts in that program next year, but we have yet to make any public announcements regarding those updates.

Speaker #7: Awesome . Thank you .

Speaker #2: Thank you . Now we're going to find our next question . Just give us a moment . And the question comes line of pit savopoulos from Cantor Fitzgerald .

Speaker #2: Your line is open . Please ask your question .

Speaker #8: Hi . This is Sara Madeiros on for Pete . Thanks for taking our questions and congrats on the progress in your quarter . Really , two questions for you .

Speaker #8: The first one being just curious to know how easy or difficult it is to find patients that are willing to enroll in the psychedelic that are willing to enroll , that are psychedelic in , and they're naive with all the attention .

Speaker #8: Focus on this class of drugs for psychiatric indications . And is there a specific demographic that are willing to enroll , such as age of patients ?

Speaker #4: Yes . Thanks so much for the question , Sarah . I'll turn that over to Dan to maybe feel .

Speaker #5: Yeah . So . Well , I would never say that enrolling a trial is easy because obviously that that's something that we pursue on a daily basis of thinking about how to get the right patients into our into our trials , what we have maintained and what we what we strive for is a representative sample so that we see a background , epidemiological rate of people who have some psychedelic experience hovering around 15% .

Speaker #5: And that tends to be what we what we aim for in our studies . We want to have a sample that looks like the the general Gad population .

Speaker #5: And so that's what we ended up with in our phase two study . And it's what we're striving for in our phase where we're using meaningfully the same inclusion exclusion criteria .

Speaker #5: three study It's a great question . And obviously a lot of the attention on the company . Recently has been on our lead asset , of course , but we're very excited about M402 , the interesting feature of how we're thinking about using our MDMA or Bora two is that in our development plan , we are developing it as a drug .

Speaker #5: So yeah , despite there being attention on these studies and attention on the category , of course , for those of us who are in it , that attention is much more obvious .

Speaker #5: Many of the participants who encounter our studies are just people who are looking for looking for studies for their Gad or MDD , and the vast majority don't find the studies because they're specifically looking for a study in the psychedelic category , or even necessarily our study .

Speaker #8: Great . And just a follow up , your earlier stage assets M402 . Can you help us understand the biological and

Speaker #8: rationale in ASD and what outcomes would look like and potentially study design in terms of chronic administration ? And are you looking at at home administration ?

Speaker #5: That would be taken either daily or as needed . So the the analogous set of drugs would be psychostimulants . And ADHD , where people with attentional difficulties are able to use psychostimulants to enhance their ability to , to pay attention when they're in environments or doing activities that that would benefit from that .

Speaker #5: So depending on the conversation people have with their doctor , they might be at school or for family events or whatever else is deemed appropriate by the the care provider and the patient working together .

Speaker #5: So, we very much see 402 working in that direction. The specific acute effects and transient effects, obviously, of O2 or MDMA are enhanced social awareness and social communication.

Speaker #5: People become more attuned to their own emotions , potentially the emotions of others . And of course a core challenge for folks who have ASD is and can be difficulty with those sorts of social communication situations and awareness of emotions in themselves and others .

Speaker #5: So we think the very direct effect of the drug , while it's on board , is exactly what will support people with those challenges .

Speaker #5: As we now disclosed , we're moving toward a early sign of efficacy study where we'll we'll look for indications that the drug is doing the thing that we think it will based on the the preclinical and some , some academic clinical evidence and , and obviously that will guide our ongoing development of the drug .

Speaker #8: Thank you .

Speaker #2: Thank you . Now we're going to take our next question . And the question comes line of Brian Abrahams from RBC Capital Markets .

Speaker #2: Your line is open . Please ask a question .

Speaker #9: Hi everyone . This is Kevin on for Brian . Congrats on a good quarter so far in all the updates . Just had a question on some of the read potential recruits .

Speaker #9: I guess we saw from one of the other competitors in the field who had recently updated on on a more accelerated timeline as well .

Speaker #9: For one of their studies . Is there perhaps an underlying reason as to why , in this case , the Emerge study got accelerated , but not the Gad studies ?

Speaker #9: And I think with the competitors as well . It was in a depression study . So is it does it have anything to do with the the particular indication that you're looking at , or does that have more to do with the the excitement around psychedelics ?

Speaker #9: And then is there any additional clarity or granularity you might be able to provide on the timing for voyage and Panorama readout , I guess ?

Speaker #9: How has the pace of enrollment in those pivotal's compared to what you saw in the phase two bees ?

Speaker #4: Yeah , I think thanks so much for the question , Evan . Yeah , I can't speak to to other companies and what they're doing in their trials , but we've been really encouraged across the board and enrollment has been strong across all three of our ongoing studies .

Speaker #4: And again , we continue to be really encouraged and committed to hitting our timelines with readouts next year . With emerge , we certainly got started with that study quite early in terms of the window of time .

Speaker #4: We had initially indicated , and continue to see enrollment strong across the board . We don't certainly believe there's any distinct difference between Gad and MDD and continue to see a lot of engagement and throughput and randomizations across all three of those studies .

Speaker #4: So we're on track and excited about getting to top line readouts as guided next year .

Speaker #9: And if I may just ask a follow up as well . So given the given that the Emerge study looks like it's it's , you know , read out a little over a year after it started , could we assume a similar time frame for the Ascend trial as well ?

Speaker #9: Perhaps maybe a little bit more , just given the increased sample size . And then I guess , kind of a broader question , just given some of the recent given the recent fundraise and kind of the strong cash position , why not just initiate the MDD studies or the the phase three ascent study , even even sooner ?

Speaker #9: Why ? I guess wait , or what's the rationale for waiting until the first one reads out ? Thanks .

Speaker #4: Yeah , thanks . With the recent financing and we feel incredibly fortunate with the support we've received , and we're positioned going next year and we're accelerating on everything that we're doing .

Speaker #4: So we are certainly not sitting on our hands and waiting for anything we like to set timelines where we feel confident we can deliver and that's really informed how we've thought about the timelines that have been announced .

Speaker #4: But of course , any opportunity we have to accelerate those timelines and bring in study initiations and bring in data readouts earlier than anticipated , we certainly will take advantage of those .

Speaker #4: So all systems go across the board in both programs and everything we're doing .

Speaker #9: Okay , great . Thank you so much .

Speaker #2: Thank you . And now we're going to take our next question . And the question comes line of Matthew Herszenhorn from Oppenheimer . Your line is open .

Speaker #2: Please ask a question .

Speaker #10: Oh hey guys . Congrats on all the progress . Thanks for taking our . So congrats on the Jama publication . Could you question please share any physician feedback you've received on that so far ?

Speaker #10: And generally just what that publication means for the psychiatry community ? And are there any details from the data to space on your discussions that you believe might still remain underappreciated ?

Speaker #10: And then I just had one follow up . Thank you .

Speaker #4: Yeah . Turn that over to Dan .

Speaker #5: Yeah . Everything about the way we plan conducted and ultimately wrote about that study was meant to to be digestible , familiar , studied design and analytic plan that that physicians and others in the space would be able to read and fully understand .

Speaker #5: We we made a real effort to make claims that were deeply supported by the evidence . We were able to generate , and obviously , the conclusions we were able to draw from the study that have allowed us to to move forward with breakthrough designation and into a phase three program that looks in many , basically all design ways except for the number of arms nearly identical to the to the successful phase two .

Speaker #5: So I think across the board that that's a recognized and appreciated . And the physician community and , and and all the other stakeholders we engage with so that the reaction has been overwhelmingly positive and , you know , we're proud of the work we did .

Speaker #5: And we're we're really glad for what it indicates about what we anticipate being able to show in the phase three programs . I think when it comes to underappreciated , perhaps the nature of a of a single monotherapy intervention without any sort of assisted therapy being able to induce remission in , in just under 50% of a patient population who start with on average , severe Gad and looking 12 weeks later and seeing that sort of remission rate from a single intervention , I think even no matter how much we look at these data and we look at them probably more than anybody , that still strikes me as just being truly , truly a remarkable opportunity for potential sea change in psychiatry .

Speaker #10: Okay . Got it . That makes sense . Appreciate it . And then the one other question we had was just if you don't mind to talk about just from the commercial opportunity , how you plan to practically manage patients considering the eight hour In-clinic administration time , just considering we get a lot of questions on the perceived challenges that you could potentially solve for in the real world setting .

Speaker #10: And maybe if you could talk about that in the context of spravato , in terms of the aggregate treatment time over a year would definitely appreciate it .

Speaker #10: Thank you so much .

Speaker #4: Yeah , thanks so much . I think when we talk about Spravato , obviously there's been a lot of attention paid and it's really encouraging .

Speaker #4: I think it's the most encouraging signals there are . The reality that psychiatry has and will adapt to the introduction of , of new treatment options .

Speaker #4: But the dynamics of , as you referenced , the dynamics and the durability of of response after Spravato session are in stark contrast to the long lasting , durable effects we've seen so far with him in 120 .

Speaker #4: So certainly the there are some parallels . There's some dynamics from an infrastructure and delivery standpoint , things that have been worked out since the launch of Spravato that we certainly believe we can leverage , but it's really almost an apples and oranges comparison when we think about the kind of treatment dynamics and the benefits that we've been able to to show so far in our clinical trials .

Speaker #4: And so that that just speaks to the overwhelming desire for for m120 that we hear from both patients and providers when we go out and conduct research with those groups .

Speaker #4: And so , again , there's certainly 120 is not . And will not ever intended to be a replica of bravado . We think it offers some significant advantages , both in terms of the magnitude of change and the durability of that change that positioned it incredibly well .

Speaker #4: So again , great , great learnings , great infrastructure that can be leveraged . But a totally different dynamic one we think is quite favorable compared to to any drugs that are on the market today .

Speaker #4: For these indications .

Speaker #10: Okay . Got it . Thanks again . Really appreciate it .

Speaker #2: Thank you . And now we're going to take our next question . And the question comes the line of Francois Brisbois from live Capital .

Speaker #2: Your line is open. Please ask your question.

Speaker #11: Hey guys . Thanks for taking the questions . Just the first one I had was on the market potential here between MDD and Gad .

Speaker #11: Can you just talk a little bit about the overlap . And obviously these are massive , massive markets . But can . One cannibalize the other here or just maybe a better understanding of the difference here between both .

Speaker #4: Yeah I'm Dan to to talk about it clinically in a second . I guess from a market opportunity . There certainly is a long history of drugs being labeled for both MDD , Gad and other indications .

Speaker #4: And psychiatry . Some of the the biggest drugs in psychiatry historically have have been labeled for for both of these indications and typically those drugs and speaking about SSRIs here have started with an mdv label and then expanded into Gad .

Speaker #4: And we think that's representative of the challenges and the limitations of those drugs in treating Gad symptoms . So while there's certainly a high degree of overlap , we don't think about it as so much as cannibalizing anything as as much as offering an opportunity to potentially treat two core symptom clusters that are overlapping in the diagnoses .

Speaker #4: But . I an ideal outcome . Any patient who walks in the door with anxiety or depression symptoms and qualifies as a diagnosis could then be directed to to rm120 .

Speaker #4: If we're successful getting both of these indications on the label , but alternative to Dan maybe to comment a little bit more about clinical presentation .

Speaker #5: Yeah . And thanks for the question , Frank . The the overlap between these two disorders is a really interesting phenomenon . And the way that we have come to think of this is that while there are certainly patients who have a major depressive episode , and as a result are diagnosed with major depressive disorder who don't have Gad level of anxiety between their depressive episodes .

Speaker #5: So while they're euthymic , they don't have depression . And there are patients with Gad who have a high level of anxiety , which is more of a constant thing , not episodic , who don't go on to have a major depressive episode for 50 to 80% of people who have either diagnosis , they would qualify for both .

Speaker #5: And that means that these are people who have had generally a pretty high level of background anxiety , often for most of their lives .

Speaker #5: And because they don't really know you're not supposed to feel that way . And until recently , there wasn't really a screening recommendation for anxiety disorders , though , that , of course , changed in the last three years with Uspstf recommendations for screening .

Speaker #5: They kind of just thought , well , this is how you're supposed to feel . And people often have a intellectualized way of thinking about that , which is to say , well , the world's a scary and dangerous place .

Speaker #5: So of course I'm anxious all the time . Many of those folks will then go on to to have a major depressive episode , at which point , because of the episodic nature of the condition , they'll end up seeking care .

Speaker #5: You know , in a world where there was more screening for depression , because that recommendation had been around for a lot longer , and because there's just this change in condition from one day to the next , so that that will lead people then to potentially seek care on on the onset of major depressive episode .

Speaker #5: So , so like Rob said , addressing one set of symptom of the symptom cluster . So getting to the anxiety side of things or the more anhedonic depression side of things .

Speaker #5: Rather than being a worry about sort of cannibalizing a market , it's much anxiety being able to provide people an overall relief from their distress than drugs that , say , just have shown efficacy for ending a major depressive episode and leave people with this thymic but but highly anxious state between those depressive episodes .

Speaker #5: So we're really enthusiastic about having been able to demonstrate the efficacy we did in phase two for for Gad and the remarkable effect we were able to show in those patients on on major scores .

Speaker #5: So we're we're highly optimistic about our phase three program in MDD as well . And again , just see this as additive benefit for people who in the majority of cases are suffering from from in essence , both .

Speaker #11: That's great . That's very helpful . And then maybe just the last one in terms of the college education that was brought up in terms of something to to work on in the future .

Speaker #11: And but I was just wondering for a field that hasn't had a lot of new options in a long time , what do you think will be the biggest hurdles here with Quels is it ?

Speaker #11: Is it easy where the data kind of speaks for itself , or do you expect the different tiers of kols where some guys are a lot more willing to try something new and maybe earlier in the treatment paradigm ?

Speaker #11: I'm just wondering where where do you think the biggest challenges might be here for the education process ?

Speaker #4: Yeah , having been out in the world in conferences and working with a lot of these kols over the last several years , we're incredibly encouraged by the strong desire for something new and encouraged by the I think the respect that high quality evidence has , has garnered from Kols and from practicing psychiatrists almost at every level .

Speaker #4: And so we can't almost can't overstate how enthusiastic many of those conversations are . Now , they're undoubtedly detractors . There's a much smaller but there will be a segment of of practicing psychiatrists who likely don't want to deliver m120 .

Speaker #4: But what we see is an overwhelming majority in our in our conversations of coals . And again , practicing psychiatrists out in the world who many of whom say , well , I'm not set up and wouldn't do deliver any of the interventional psychiatry treatments today , but I certainly have an intent to do so within 120 .

Speaker #4: Should it get approved . And so while there's going to be a major effort ahead so that we shape the market and make sure that the world is fully aware of the exciting data we are generating , you know , we don't see any sort of barrier in terms of getting that kind of engagement .

Speaker #4: And if anything , it's quite rare to see the kind of enthusiasm that we do as a field . This far in advance of pivotal readouts and going back several years now .

Speaker #4: So remain highly encouraged , but highly focused on getting that messaging right . And , and amplifying it to the greatest extent possible .

Speaker #11: That's great . And this privado help here or do you consider it so different that it's not because someone prescribes trovato that they're more likely to prescribe this here ?

Speaker #4: Well , we think any sort of infrastructure build out that has happened certainly is something that we can leverage . And for , for providers to , quite frankly , for providers to be delivering as many treatment sessions of spravato as they have over the past several years .

Speaker #4: And then to see something with higher magnitude , more durable effect that seems to to drive a whole different kind of outcome for for some of these patients , you know , that contrast , we feel very good about and think positions us incredibly well .

Speaker #4: So certainly we think there is a segment of psychiatry that is delivering not only spravato but but other interventional psychiatric treatments and those tend to be some of the earlier adopters .

Speaker #4: And some of those folks who are the most enthusiastic . But it is certainly not limited to spravato centers or providers who are coming to us and talking about their enthusiasm for what M-120 could offer patients .

Speaker #11: Thank you very much .

Speaker #4: Thanks .

Speaker #11: Brian .

Speaker #2: Thank you . Now we're going to take our next question . And it comes line of Amy Fadia from Needham and Company . Your line is open .

Speaker #2: Please ask your question .

Speaker #12: Hi . Good afternoon . Thanks for taking my question and congrats on the quarter . My first question is , can you talk about the persistency rates of patients and voyage and panorama studies that you're seeing on a blinded basis and how that might be progressing relative to the dropout rates that you'd assumed in the trial design and in terms of what we can expect from a communication perspective , should we assume that when you do conduct the sample size , estimation , that will not be made public ?

Speaker #12: And then I have 1 or 2 other questions . Thank you .

Speaker #4: Yeah . Thanks so much for the question . We won't comment on ongoing studies or even unblinded data from those studies until we hit a point of having data and being able to announce fully that the outcomes of a study .

Speaker #4: But we certainly have been really encouraged . And a lot of the metrics and really all of the metrics that we've been measuring in the trials and , you know , continue to be committed to executing these studies with the highest quality and on time and get to results at appropriate time next year .

Speaker #4: And again , we have in commented specifically on whether or not we would announce a sample Re-estimation publicly or not .

Speaker #12: Got it . That's helpful . And then in the the panorama and the sense studies where you have two doses of m-120 , once we sort of get the results and especially from a regulatory perspective , how much of a difference across the doses would you like to see ?

Speaker #12: Or , you think the FDA would like to see in terms of efficacy and safety , to be able to sort of address the function and question or maybe a dose dependent change across the doses .

Speaker #12: Question .

Speaker #4: Well , I think the important point there is about the need for programs to demonstrate dose response . So when we think about things like functional unblinding , which are problems across all psychiatry , anything really in the CNS , of course , we think demonstration of dose response is is really critical and gives a high degree of confidence in there being a real treatment effect of a drug .

Speaker #4: And that's why we did the phase two study . We did . And uniquely in our field , have comprehensively characterized the dose response .

Speaker #4: So we have a study that has been completed and published and that we're really excited about . Of course , that demonstrated both clinically from an observational standpoint , but also statistically that there is a dose response .

Speaker #4: And that was an even in light of the fact that virtually all patients , regardless of the dose of active drug they received , reported being functionally unblinded by correctly guessing that they were on drug .

Speaker #4: And so there's not really a question at this point in our minds about whether there is a dose response , because we did a dedicated study to demonstrate that , and it successfully proved that there is .

Speaker #4: And so the availability , the existence of the lower dose , the 50 microgram arm really is a sort of prospective use in the study .

Speaker #4: And that it allows us in a consent process , try to confound expectations , to effectively say to a patient , if you were to feel the effects of drug on the day of dosing , you can't assume it's the full real dose of drug .

Speaker #4: It actually is a dose of drug . In the prior study that we showed is functionally unblinding , but does not have clinical activity in reducing anxiety symptoms .

Speaker #4: And so it is a design element . And a sort of functional control . In the study . But in terms of outcomes of the data , primary outcome measures in both voyage and panorama and an emergent ascend is is testing 100 micrograms versus placebo .

Speaker #4: And no outcome of the 50 microgram group can can alter the finding of that primary analysis . So regardless of what happens in terms of the group response to 50 micrograms will be seeking to clinically and statistically prove that M121 100 micrograms is superior to placebo .

Speaker #12: Got it . That's that's very helpful . Maybe my last question . If I could squeeze one in , you know , the feedback that we've received from a lot of is that , you know , the key differentiating factor and maybe a huge unmet need is the potential to reduce the frequency of retreatment .

Speaker #12: Can you comment on any sort of follow up or sort of experience from the phase two that can throw some light on what is sort of the range of .

Speaker #12: Time frame within which patients will require a retreatment . Thank you .

Speaker #4: Yeah . Thanks so much . So what we saw in terms of of the average curves and responses that we didn't see any sort of deterioration of effect out to 12 weeks .

Speaker #4: And because of that , we can't really even attempt to project those curves and arrive at a time when we would anticipate reliably that patients would need a retreatment .

Speaker #4: And of course , we're trying to characterize that in part B of our of our phase three studies that are ongoing and planned .

Speaker #4: You know , we certainly hear and have looked at real world use and compassionate use programs and have been encouraged by the durability of of LSD that that can last well beyond 12 weeks in some of those studies .

Speaker #4: And are really excited to characterize that in a robust fashion . In our phase three program . But it's a little bit premature to say decisively or exactly where we expect retreatment , although what we do know is that and we believe we have alignment around the right approach to characterizing this is is to do exactly what we're doing in the part B of the phase three studies , which is to screen patients when they have a recurrence of symptoms , of 16 or greater .

Speaker #4: Or mattress of 20 greater , depending on the study . The availability of open label retreatment and to to try to characterize those dynamics .

Speaker #4: The intervals between doses and the ultimate frequency over the course of of a 12 month period in the study . So really excited to get to those data .

Speaker #4: But but a little bit premature to say say so today .

Speaker #12: Makes sense . Thank you .

Speaker #2: Thank you . And now we're going to take our next question . Just give us a moment . And the question comes line of Sumant Kulkarni from Canaccord Genuity .

Speaker #2: Your line is open . Please ask your question .

Speaker #13: Good afternoon . Nice to see all the progress and thanks for taking our questions . I have a few first , because MDD is more episodic versus Gad that has more chronic characteristics .

Speaker #13: Do you expect any difference in durability of effect with Rm120 ? And what could that mean for a number of treatments per year ?

Speaker #13: For each indication ? And would you expect price per treatment for rm120 to be the same in Gad and MDD ? And then I have a follow up .

Speaker #4: Yeah . Thanks so much . I mean , exactly what we're doing . The studies is to try to characterize that . We believe that based on what we've seen in that the curves is describing for both anxiety and depression symptoms in the phase two , we saw somewhat similar response patterns .

Speaker #4: And so we're certainly very focused and very interested in characterizing those treatment responses . And retreatment characteristics . And that will certainly inform everything from how we approach clinical , regulatory and pricing discussions .

Speaker #13: Got it . And the follow up , if you look at slide 23 , in the one Rm120 commercial framework of your latest slide , deck , it says psychotherapy is not offered or required , but may be added outside a dosing session based on individual needs and goals .

Speaker #13: So in real world usage , what percentage of patients do you think this might be applicable to ? And how would that impact commercial or reimbursement based variables ?

Speaker #4: Well , I think overall we hope that every patient gets the availability of every treatment . We know that psychotherapy is not reimbursed , particularly well today .

Speaker #4: And , you know , we don't it's not not our . Position or places with 20 to to exactly change that . So certainly we expect in the real world that some patients who are already in psychotherapy would be candidates for rm120 and could likely continue on with certainly again from , from observations out in the world , seeing both patients and academic studies and in real world use who are administered a psychedelic and then decide to pursue psychotherapy thereafter .

Speaker #4: So we , of course , want to have labeling and the development program that enables the widest adoption and the widest set of use cases for for rm120 .

Speaker #4: Should we get it approved and out in the world ? But we do not . As part of the development program , you know , require or deliver any sort of psychotherapy in our program .

Speaker #13: Got it . Thanks .

Speaker #4: Thanks , Mark .

Speaker #2: Thank you . And now we're going to take our next question . And the next question comes from the line of Patrick Trujillo from H.C.

Speaker #2: Wainwright . Your line is open . Please ask a question .

Speaker #14: Thanks . I have a couple of questions . The first is I think you noted that the phase three program in Gad is powered 90% to detect a five point improvement on the Ham-a .

Speaker #14: And I think that compared to the 7.7. placebo adjusted difference observed in the phase two B , I'm wondering if you can put that five point threshold into a clinical context .

Speaker #14: How should we think about the relevance to patients in real world outcomes ? And then just to , I guess , a clarification , you know , for the depression program emerge , have you shared how that study is powered as well ?

Speaker #14: And and your expectations heading into that mid 2026 data readout ?

Speaker #4: Yeah . Thanks so much for the question , Patrick . Yeah . So I mean , when we look at the context of historical and currently approved products in generalized anxiety disorder , we typically see under five point placebo adjusted change and more commonly somewhere in the mid mid three point over placebo and on an absolute basis , typically in the low teens .

Speaker #4: In terms of the absolute magnitude of ham-a improvement for for the approved therapies . And so in that context , we saw almost 22 point improvement in the 7.7 placebo adjusted delta in our face study at 12 weeks after a single dose of of drug .

Speaker #4: And so we're trying to be , of course , conservative and empowering assumptions so that we can give ourselves a good probability of success .

Speaker #4: And the same approach applies . We want to see clinically meaningful change with in both Gad and MDD . And that's how we've we've approached the powering and design of of all four of the phase three studies .

Speaker #14: So I think earlier 2025 , you know , described as a year of constructive dialogue with the FDA , I'm wondering if you can elaborate on key areas of alignment that have been achieved so far and what still needs to be finalized ahead of potential NDA submissions .

Speaker #14: And as well , would you anticipate submitting the NDA for Gad with the 12 week data , or would you need the long ?

Speaker #14: Would you need longer ? Term data from part B prior to submitting ?

Speaker #4: Yeah , we've had an ongoing and constructive dialogue with FDA and , you know , very grateful for for their level of engagement .

Speaker #4: And under the Breakthrough Therapy designation program . And we've really taken advantage of that . And try to seek an ongoing dialogue and a high degree of alignment on all the studies were conducting , including in particular , the phase three studies .

Speaker #4: And so , you know , we don't tend to speak about specific agency interactions on that ongoing basis , but we do believe there's a high degree of alignment .

Speaker #4: We believe the most important data that the data that we need to to demonstrate are the part A from our phase three studies to demonstrate at 12 weeks in Gad and at six weeks in MDD , that we have two studies that show hopefully the safety and effectiveness of 120 .

Speaker #4: And so that's been our approach . And again , incredibly constructive dialogue . And as we progress and and deliver pivotal data over the course of 2026 , we'll continue that dialogue and do everything we a team has an incredible track record of hitting our milestones and and being incredibly efficient with how we operationalize our program .

Speaker #4: And we continue continue to do that in clinical development . We intend to do that through the remaining regulatory and commercial milestones , lie ahead .

Speaker #14: Lastly , I'm wondering if you're anticipating an FDA advisory committee meeting as part of the review process for Gad and or MDD , and how is your clinical development program positioned you to prepare for that discussion ?

Speaker #4: Our approach has been to generate the strongest , most robust evidence and data package to stand up to to any , any stakeholder , any form of scrutiny .

Speaker #4: And so whether or not an advisory committee is is required , we we certainly will be prepared . But it's premature to say until we've gotten that stage of review cycle and had the dialogue with FDA at that point to say one way or another , whether an advisory committee would would be required or not .

Speaker #14: Great . Thanks so much .

Speaker #4: Thanks , Patrick .

Speaker #2: Thank you . Now we're going to take our next question . And it comes from the line of Christopher Chen from bird . Your line is open .

Speaker #2: Please ask a question . Excuse me . Christopher , your line is open .

Speaker #15: Can you hear me now ?

Speaker #4: Yeah , we can .

Speaker #15: Okay , great . Yeah , I apologize , I think I'm having some some connection issues , but . But thanks for taking my questions .

Speaker #15: And congrats on the quarter . Just regarding the currently running phase three , can you talk a bit more about the safety monitoring in that interim three month period ?

Speaker #15: Following the initial dosing ? I'm just curious what guardrails are in place for patients and how you told that line between , you know , ensuring support for these patients , while not crossing over into psychotherapy .

Speaker #15: And then I do have a follow up .

Speaker #4: Yeah , I'll turn it over to Dan .

Speaker #5: Yeah . I mean , it's a great question . And obviously we want to ensure that the safety of people as they participate in our in our studies through the entire duration of the participation for a participant , that's for the full year .

Speaker #5: So folks are in regular contact with , with the site . And we do regular assessments . We do regular CSRs to to ensure that no one is has developed suicidality .

Speaker #5: We we are very attentive to these things , but that kind of monitoring is completely consistent and coherent with the history of psychiatric drug development .

Speaker #5: And , you know , it says something about the the category and assumptions that had been made prior , prior to some of our research about what was required to do research in the category .

Speaker #5: And so , you know , the difference between safety monitoring and if someone were to have a safety issue and we needed to refer them out to to higher level of care , of course we could do that .

Speaker #5: At that point , the person would be discontinued from the study because that would be a an event leading to to early termination from the study .

Speaker #5: But none of that even borders attempts to change symptoms through an engagement or and interaction . So none of that , you know , in no way is any of that safety monitoring , even touch on the sorts of interventions that would constitute psychotherapy .

Speaker #4: I'll just make one final point to emphasize this . Psychotherapy is a defined construct and something that has a long history . And and I think there's there's been attempts to sort of conflict the meaning of what that is .

Speaker #4: And so , you know , we we are very intentional about how we instruct the sites to conduct the study and that is to to specifically not deliver psychotherapy in the kind of our studies .

Speaker #4: And we've maintained a high degree of adherence to that throughout our development program .

Speaker #15: Great , great . No . Super helpful . And then just real quick , just regarding the treatment session itself , do you have protocols in place just in the , you know , the rare event that a patient might need to stay beyond that eight hour time point and then will the final data read include data on on instances , instances of that .

Speaker #4: Premature . Right now to say exactly which data we'd be sharing , at which point in time , we certainly tend to be complete with our disclosures at the time we have top line data from our phase three studies , but , you know , we have plans in place and contingency plans in place for all sorts of eventualities as as any clinical trial does .

Speaker #4: But we've been really encouraged with the OT formulation and our approach to patient safety monitoring . And phase three have been really encouraged by what we've been observing so far .

Speaker #4: And throughout our development program . And it's really aligned with our intention , which is to develop an incremental body of evidence that arrives at a really efficient delivery framework for , for hopefully labeling discussions and commercialization of the product .

Speaker #15: Great . Thank you .

Speaker #16: Thank you .

Speaker #2: The speakers are no further questions for today . This concludes today's conference call . Thank you for participating . You may now all disconnect .