Q1 2024 Mind Medicine (MindMed) Inc Earnings Call
Operator: Good day, and thank you for standing by. Welcome to the MindMed Q1 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Rob Barrow, CEO of MindMed. Please go ahead.
Good day, and thank you for standing by.
Robert Barrow: Welcome to the mines that Q1 2024 earnings conference call.
Operator: At this time all participants are in a listen only mode.
Robert Barrow: After the speaker's presentation, there will be a question and answer session.
Operator: Ask a question during the session you will need to press star one on one on your telephone you will then hear an automated message advising your hand is right to.
Operator: To withdraw your question. Please press star one one again.
Operator: Please be advised that today's conference is being recorded.
Robert Barrow: I'd now like to hand, the conference over to your first speaker today, Rob barrel E. All of mine that please go ahead.
Robert Barrow: Thank you, and good afternoon, everyone. Welcome to our first quarter 2024 financial results and corporate update conference call. The press release reporting our financial results is available in the Investors and Media section of our website, and our quarterly report on Form 10-Q for the quarter ended March 31st, 2024 is being filed today with the Securities and Exchange Commission. During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and our future These statements are subject to various risks, such as changes in market conditions and difficulties associated with the research and development and regulatory approval processes.
Robert Barrow: Thank you and good afternoon, everyone.
Robert Barrow: These and other risk factors are described in the filings made with the SEC, including our annual report on Form 10-K and our Form 10-Q being filed today. Forward-looking statements are based on the assumptions, opinions, and estimates of management at the date the statements are made, including the non-occurrence of the risks and uncertainties that are described in the filings made to the SEC or other significant events occurring outside of MindMed's normal course of business.
Robert Barrow: Welcome to our first quarter 2024 financial results and corporate update conference call.
Robert Barrow: The press release reporting our financial results is available in the investors and media section of our website.
Robert Barrow: Our quarterly report on Form 10-Q for the quarter ended March 31, 2024 is being filed today with the Securities and Exchange Commission.
Robert Barrow: 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, our anticipated cash runway and our future expectations plans partnerships and prospects.
Robert Barrow: These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development regulatory approval processes.
Robert Barrow: These and other risk factors are described in our filings made with the SEC, including our annual report on Form 10-K.
Robert Barrow: Our Form 10-Q being filed today.
Robert Barrow: 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, where other significant event occurring outside of Biomed's normal course of business.
Robert Barrow: Please be careful not to place undue reliance on these forward-looking statements, which are made as of today, May 8, 2024. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law. Joining me on today's call are Dr. Daniel Karlin, our Chief Medical Officer, and Dr. Francois Lillenthal, our Chief Commercial Officer. Earlier today, we announced the transition of Schond Greenway, who, as of May 3rd, is no longer serving as our Chief Financial Officer.
Robert Barrow: You are cautioned not to place undue reliance on these forward looking statements, which are made as of today may eight 2024.
Robert Barrow: <unk> disclaims any obligation to update such statements, even if management's views change except as required by law.
Speaker Change: Joining me on today's call are Dr. Daniel Carlin, our Chief Medical Officer, and Dr. Francois Blah Blah blah.
Robert Barrow: Our chief commercial officer.
Robert Barrow: Earlier today, we announced the transition of Shine Greenway, whereas of Mayfair, no longer serving as our Chief financial Officer.
Robert Barrow: On behalf of the board and the company, I want to thank Sean for all of his hard work and dedication to our mission over the past two years and wish him the best of luck in his future endeavors. We've retained an executive search firm to assist in identifying a new chief financial officer to support the next phase of MindMed's growth and evolution. Moving back to our first quarter results, we're excited to be providing this financial and business update during this important period for MindMed.
Robert Barrow: On behalf of the board and the company I want to thank John for all of his hard work and dedication to our mission over the past two years and wish him. The best of luck in his future endeavors.
Robert Barrow: We've retained an executive search firm to assist in identifying a new chief financial officer to support the next phase of <unk> growth and evolution.
Robert Barrow: Moving back to our first quarter results, we're excited to be providing this financial and business update during this important period for mine that.
Robert Barrow: It's been a fantastic start to the year and a highly productive quarter for MindMed, highlighted by the positive 12-week data from our Phase 2B clinical trial for MM120 and the treatment of generalized anxiety disorder, or GAD. Alongside the data, we were thrilled to announce that FDA designated MM120 as a breakthrough therapy in the treatment of GAD. This designation is reserved for treatments that are intended to treat a serious or life-threatening condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.
Robert Barrow: It's been a fantastic start to the year and highly productive quarter for mindset, which was highlighted with positive 12 week data from our phase <unk> clinical trial for <unk>, and then 120 and the treatment of generalized anxiety disorder or J D.
Robert Barrow: Alongside the data we were thrilled to announce the FDA designated and then 120 as a breakthrough therapy in the treatment of J D.
Robert Barrow: This designation is reserved for therapies that are intended to treat a serious or life threatening condition.
Robert Barrow: For which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies.
Robert Barrow: We believe receiving this FDA designation and the positive phase 2b trial data we shared reinforces MM120's potential as an emerging best-in-class product compared to today's standards of care. On the heels of the MM120 data in March, we completed a successful, oversubscribed, unwritten offering and concurrent private placement, raising approximately $175 million in gross proceeds before deducting transaction fees and other offering-related expenses.
Robert Barrow: We believe receiving this FDA designation of the positive phase <unk> trial data, we shared reinforces <unk> potential as an emerging best in class product compared to today's standards of care.
Robert Barrow: On the heels of the <unk> 120 data in March we completed a successful oversubscribed underwritten offering and concurrent private placement raising approximately $175 million in gross proceeds afford deducting transaction fees and other offering related expenses.
Robert Barrow: Participants in the offering included some of the most respected blue-chip institutional healthcare investors, which we believe further validate the great work that we have been able to achieve over the past year. Most importantly, this financing puts MindMed in its strongest financial position ever, and we expect that it will fund the company through important development milestones for MM120 and other programs in our pipeline. Finally, we announced several scientific posters and presentations that we have shared at various medical meetings.
Robert Barrow: Participants in the offering including some of the most respected blue chip institutional healthcare investors, which we believe further validate the great work that we have been able to achieve on capacity here.
Robert Barrow: Most importantly, this financing puts nine that in its strongest financial position ever and we expect that it will fund the company through important development milestones for <unk> and $1 20, and other programs in our pipeline.
Robert Barrow: Finally, we announced several scientific posters and presentations, we've shared at various medical meetings.
Robert Barrow: In April, we presented posters at the European Psychiatric Association's 2024 Congress in Budapest, Hungary, and the Anxiety and Depression Association of America 2024 Conference in Boston. This month, we present a detailed result from the American Psychiatric Association's 2024 Congress and the International Society for Pharmacoeconomics and Outcomes Research. These poster presentations cover data from our Phase IIb trial of MM120 and GAD, as well as studies related to the epidemiology and growing burden of GAD, which we believe remains underappreciated.
Robert Barrow: In April we presented posters at the European Psychiatric Association 2020 for Congress in Budapest, Hungary.
Robert Barrow: Anxiety and Depression Association of America 2024 conference in Boston.
Robert Barrow: This month, we presented detailed results at the American Psychiatric Association 2020 for Congress and the International Society for Pharmacodynamics and outcomes research.
Robert Barrow: These poster presentations covered data from our phase two B trial, and then 120 and JD as well as studies related to the epidemiology and growing burden of <unk>, which we believe remains underappreciated.
Robert Barrow: Additionally, our collaborators from University Hospital Basel will be sharing one-year follow-up results from a Phase II investigator-initiated study of lysorgye in the treatment of anxiety disorders at the Society of Biological Psychiatry 2024 Annual Meeting being held May 9-11 in Austin, Texas.
Robert Barrow: Additionally, our collaborators from University Hospital, Basel will be sharing one year follow up results from a phase two investigator initiated study of <unk> in the treatment of anxiety disorders.
Robert Barrow: A society of biological Psychiatry, 2024 annual meeting being held May <unk> through alliance in Austin, Texas.
Robert Barrow: Overall, increasing our visibility at these key scientific meetings represents an important strategic initiative for MindMed in 2024 as we look to expand awareness of our work and build MindMed's profile within the scientific community. Our progress comes at a crucial time with an urgent need for better treatments to address the epidemic of brain health disorders, a situation that has grown significantly worse over the past several years.
Robert Barrow: Overall, increasing our visibility at these key scientific meetings represents an important strategic initiative initiative to remind that in 2024 as you look to expand awareness of our work and <unk> profile within the scientific community.
Robert Barrow: Our progress comes at a crucial time with an urgent need for better treatments to address the epidemic of brain health disorders, a situation that's grown significantly worse over the past several years.
Robert Barrow: In our lead indication, GAD, for example, a recent mental health prevalence study that was prepared for the Substance Abuse and Mental Health Services Administration found that 10% of U.S. adults report having symptoms consistent with the GAD diagnosis, making it the second most common mental health disorder among adults 18 to 65 years old. In comparison to historical studies of the prevalence of GAD, the condition appears to have tripled in the last two decades alone.
Robert Barrow: And our lead indication for example, our recent rental house prevalent study that was prepared for the substance abuse and mental health services administration, if I'm at 10% of U S. Adults report, having symptoms consistent with the J D diagnosis, making it the second most common mental health disorder. Among adults 18 to 65 years old.
Robert Barrow: In comparison to historical studies of the prevalence of JD. The condition appears to have tripled in the last two decades.
Robert Barrow: Our MM120 program in GAD has seen extraordinary progress over the past year, culminating in the four-week data from our Phase 2B trial that we announced in December 2020, and the subsequent positive 12-week follow-up data that we shared in March. Results have exceeded our target product profile for MN-120, demonstrating a significant improvement in all analyzed endpoints for up to 12 weeks after just a single dose and without any additional therapeutic intervention. We believe these results demonstrate the fast-acting and durable clinical activity of MN120 along with its favorable tolerability profile.
Robert Barrow: And then 120 program and JD has been extraordinary progress over the past year, culminating in the four week data from our phase <unk> trial, we announced in December 2023, and the subsequent positive 12 week follow up data that we shared in March.
Robert Barrow: Results have exceeded our target product profile for <unk> and 120, demonstrating a significant improvement in all analyzed endpoints for up to 12 weeks. After just a single dose and without any additional therapeutic intervention.
Robert Barrow: We believe these results demonstrate the SaaS acting durable clinical activity of them and we're in 'twenty, along with its favorable tolerability profile.
Robert Barrow: In the context of currently available therapies for GAD, these data represent a major step forward in a field that has suffered from practically no innovation in the past 20 years. Cohen's D standardized effect size of 0.81 in the 100 microgram dose group at 12 weeks is more than double the estimated effect size in the current standards of care for GAD, which are estimated to have effect sizes below 0.4 on average. We believe this result can wholly be attributed to the stand-alone effect of MM120 as the trial was conducted in the absence of any other therapeutic intervention.
Robert Barrow: In the context of currently available therapies for.
Robert Barrow: These data represent a major step forward and I feel that it suffered from practically no innovation in the past 20 years.
Robert Barrow: The Cohen's D standardized effect size 0.81, and the 100 microgram dose group at 12 weeks is more than double the estimated effect size of the current standards of care for J D.
Robert Barrow: Which are estimated to have effect sizes below 0.4 on average.
Robert Barrow: We believe this result can hardly be attributed to the Standalone effect of <unk> 120, as the trial was conducted in the absence of any other therapeutic intervention.
Robert Barrow: We also reported results from our MM120 PK Bridging Trial, evaluating the MM120 Orally Dissolving Tablet, or ODT formulation, that delivered upon our clinical aspirations for the new product formulation. The ODT formulation provides numerous benefits, including extending MM120's intellectual property profile, as well as product performance benefits, such as enhanced bioavailability and increased area under the curve of therapeutic concentrations, that further differentiate MM120's Overall, the characteristics of the ODT formulation demonstrated in the PK Bridging Trial offer what we believe is compelling evidence for its differentiated clinical profile and support our decision to progress the ODT formulation into Phase 3 development.
Robert Barrow: We also reported results from our and then 120 PK bridging trial evaluating the and then 120 orally dissolving tablet or ODT formulation that delivered upon our clinical aspirations for the new product formulation.
Robert Barrow: The ODT formulation provides numerous benefits, including extending amendment <unk> intellectual property profile as well as product performance benefits such as enhanced by volatility and increased area under the curve therapeutic concentrations that further differentiate and then 120 <unk> clinical profile.
Robert Barrow: Overall, the characteristics of the ODT formulation demonstrated the PK bridging trial offer what we believe is compelling evidence for its differentiated clinical profile and supports our decision to progress the ODT formulation into phase III development.
Robert Barrow: With this exciting progress, we believe we have successfully achieved the goals of Phase 2 development for MM120 and expect to advance MM120 into pivotal Phase 3 clinical trials for GAD. We anticipate having an end of Phase 2 meeting with FDA in the second quarter of 2024 to align the scope of our Phase 3 development program, and initiating our Phase 3 clinical program in the second half of 2024. Additionally, based on the promising data we have observed for MN120 and indications beyond GAD, such as depression, we are actively evaluating additional clinical indications and believe the overall development program for MN120 may represent the best-in-class treatment for GAD and beyond.
Robert Barrow: With this exciting progress we believe we have successfully achieved the goals of the phase two development for and then 120 and expect to advance your minimum 20 independent all phase III clinical trials for JD.
Robert Barrow: We anticipate having an end of phase two meeting with FDA in the second quarter of 2024 to align with the scope of our phase III development program.
Robert Barrow: To initiate our phase III clinical program in the second half of 2024.
Robert Barrow: Additionally, based on the promising data we've observed and then when <unk> in indications beyond Gd such as depression.
Robert Barrow: Actively evaluating additional clinical indications and please the overall development program for Amendment <unk> may represent the best in class treatment for <unk> and beyond.
Robert Barrow: As we build momentum in the development of M120, we are also strategically enhancing our focus towards commercial planning. As you may recall from our analyst day in March, market research shows strong enthusiasm for MN-120, with 74% of surveyed healthcare practitioners indicating that FDA-approved psychedelic treatments will change their approach to treating anxiety and depression. This positive sentiment aligns with the success of Johnson & Johnson's Spravato, or intranasal ascetamine, which is rapidly approaching blockbuster status.
Robert Barrow: As we build momentum in development of Am 120, we are also strategically enhancing our focus towards commercial plan.
Robert Barrow: As you may recall from our analyst day in March market research showed strong enthusiasm for <unk> hundred 20, with 74% of surveyed health care practitioners, indicating that SBA approved psychedelic treatments will change their approach treating anxiety and depression.
Robert Barrow: This positive sentiment aligns with the success of Johnson, <unk>, Johnson's bravado, or intranasal ask editing, which is rapidly approaching blockbuster status.
Robert Barrow: Revata's impact extends beyond its own use case, as it has helped pave the way for the interventional psychiatry model. This established model includes well-defined patient care reimbursement pathways, RIMS documentation processes, and logistics infrastructure, all of which we believe can be readily leveraged for MN120, which was successful in clinical trials and ultimately approved by the FDA in March. Our second lead program is MN402, which is the R-enantiomer of MDMA. We believe MDMA-402 holds promise for its potential pro-social effects and favorable tolerability profile versus racemic MDMA or the S&A tumor.
Robert Barrow: <unk> Pak extends beyond its own use case and it has helped pave the way for the interventional psychiatry model.
Robert Barrow: This established model includes well defined patient care reimbursement pathways rems documentation processes, our logistics infrastructure all of which we believe can be readily leveraged for any of our $1 20, a successful in clinical trials and ultimately approved by the FDA in market.
Robert Barrow: Our second lead program is <unk>, which is the our and Anti-american MDMA.
Robert Barrow: We believe <unk> holds promise for its potential pro social effects was favorable tolerability profile versus racemic MDMA or the echelon timber.
Robert Barrow: The focus of our MM402 program is to develop a regularly administered product that treats the core symptoms of Autism Spectrum Disorder, or ASD, in particular social communication difficulties. Remarkably, despite the significant and increased prevalence of ASD, there are currently no approved therapies specifically targeted at its course.
Robert Barrow: The focus for Brian and then for two programs to develop a regulatory administered product that treats the core symptoms of autism spectrum disorder or <unk> in.
Robert Barrow: In particular, social communication difficulties.
Robert Barrow: Remarkably despite significant and increasing prevalence of ASD. There are currently no approved therapies, specifically targeted at its core symptoms.
Robert Barrow: With robust preclinical evidence supporting our approach, we have initiated our first clinical trial of MMM402, a single ascending dose trial in adult healthy volunteers, in the fourth quarter of 2023. This Phase I trial is intended to characterize the tolerability, pharmacokinetics, and pharmacodynamics of MM402 and will enable further clinical studies to characterize the effects of repeated daily doses of MM402 and the exploration of early signs Concurrently, our collaborators at UHB have conducted a comparative Phase I pharmacokinetic and pharmacodynamic trial of R, S, and racemic MDMA, with data anticipated in the second quarter of 2024.
Robert Barrow: With robust preclinical evidence supporting our approach we have initiated our first clinical trial of <unk>.
Robert Barrow: We believe that the results from this trial will expand and expedite our understanding of MN402's pharmacological profile as we progress into later stage clinical development. Now, we turn to our financial results for the quarter ending March 31st, 2024. As of March 31, 2024, the company had cash and cash equivalents totaling $252.3 million, compared to $99.7 million as of December 31, 2023. We believe that our cash and cash equivalents will be sufficient to fund our operations into 2026 based on our current operating performance. For the quarter ended March 31, 2024, net cash used in operating activities was $16.6 million, compared to $13.3 million for the same period in 2023.
Robert Barrow: 402, a single ascending dose trial in adult healthy volunteers in the fourth quarter of 2023.
Robert Barrow: This phase one trial is intended to characterize the tolerability pharmacokinetics and pharmacodynamics of <unk> and will enable further clinical studies to characterize the effects of briefly daily doses, and then <unk> and the exploration of early signs of efficacy in the ASD population.
Robert Barrow: So currently our collaborators that UHD conducted a comparative phase one pharmacokinetic and pharmacodynamics trials R. S racemic MDMA with data anticipated in the second quarter of 2024.
Robert Barrow: We believe that the results from this trial will expand and expedite our understanding and then Proteus pharmacological profile as we progress into later stage clinical development.
Robert Barrow: We'll now turn to our financial results for the quarter ended March 31 2024.
Robert Barrow: As of March 31, 2024 company had cash and cash equivalents totaling $252 3 million compared.
Robert Barrow: Compared to $99 7 million as of December 31, 2023.
Robert Barrow: We believe that our cash and cash equivalents will be sufficient to fund our operations into 2026 based on our current operating plan.
Robert Barrow: For the quarter ended March 31, 2024, net cash used in operating activities was $16 6 million compared.
Robert Barrow: Compared to $13 3 million for the same period in 2023.
Robert Barrow: Research and development expenses were $11.7 million for the quarter ended March 31, 2024, compared to $12.6 million for the same period in 2023, representing a decrease of $0.9 million. This decrease was primarily due to a decrease of $0.6 million in expenses related to our MN402 program. A decrease of $0.5 million in expenses related to preclinical activities, partially offset by an increase of $0.3 million in internal personnel costs as a result of increasing research and development capability.
Robert Barrow: Research and development expenses were $11 $7 million for the quarter ended March 31, 2024, compared to $12 6 million for the same period in 2023, representing a decrease of <unk> $9 million.
Robert Barrow: This decrease was primarily due to decreased <unk> 6 million.
Robert Barrow: Related to our <unk> program.
Robert Barrow: A decrease of <unk> 5 million in expenses related to preclinical activities.
Robert Barrow: Partially offset by an increase of <unk> $3 million internal personnel cost as a result of the increasing research and development capabilities.
Robert Barrow: General and administrative expenses were $10.5 million for the quarter ended March 31, 2024, compared to $8.3 million for the same period in 2023, an increase of $2.2 million. The increase was primarily attributable to increased stock-based compensation expense of $1.1 million and an increase of $0.7 million in personnel-related expenses due to an increase in headcount to support the growth of our business. The company's net loss of the quarter ended March 31, 2024 was $54.4 million, compared to $24.8 million for the same period in 2023. This increase was primarily due to changes in the fair value of the 2022 U.S. dollar financing warrants of $27.7 million.
Robert Barrow: General and administrative expenses were $10 5 million for the quarter ended March 31, 2024, compared to $8 3 million for the same period in 2023, an increase of $2 $2 million.
Robert Barrow: The increase was primarily attributable to increased stock based compensation expense of $1 1 million and an increase of <unk> $7 million in personnel related expenses due to an increase in head count to support the growth of our business.
Robert Barrow: The company's net loss for the quarter ended March 31, 2024 was $54 4 million compared to $24 8 million for the same period in 2023.
Robert Barrow: This increase was primarily due to changes in the fair value of the 2022 U S dollar financing warrants of $27 $7 million.
Robert Barrow: In conclusion, this is a very exciting time for MindMed. We believe that the data on MM120 and GAD that we shared validates our scientific understanding of MM120's mechanisms of action and shows the potential for an emerging best-in-class product profile compared to today's standard of care. We are excited to be on the cusp of moving forward into Phase 3 with this program, which we currently expect in the second half of the year, following our anticipated meeting in Phase 2 with FDA.
Robert Barrow: In conclusion this is a very.
Robert Barrow: Very exciting time for mindset.
Robert Barrow: We believe that the data on and then 120 <unk> <unk>.
Robert Barrow: We shared validates our scientific understanding of their 100 Twenty's mechanism of action and shows the potential for an emerging best in class product profile compared to today's standard of care.
Robert Barrow: We are excited to be on the cost of moving forward into phase III with this program, which we currently expect in the second half of the year following our anticipated into phase two meeting with FDA.
Robert Barrow: In conclusion, I want to extend my sincere appreciation and gratitude for the critical work and unmatched execution that has brought MindMed ever closer to realizing our mission. I would like to thank our highly talented and deeply committed team, our research collaborators, and clinical investigators. Our investors and the many other individuals who have been supportive, including especially our patients and their families. We are working tirelessly to deliver on the therapeutic potential of our pipeline and to transform the treatment landscape for the many individuals living with brain health. With that, I'd like to thank you all again for joining us today, and I'm happy to take any questions. Thank you so much.
Speaker Change: Before concluding our call I want to ask some excellent tier appreciation and gratitude the critical work.
Robert Barrow: Unmatched execution, but it's brought biomed ever closer to realizing our mission.
Robert Barrow: I would like to thank our highly talented and deeply committed team our research collaborators and clinical investigator teams, our investors and the many other individuals who have been supportive, including especially our patients and their families.
Robert Barrow: We are working tirelessly to deliver on the therapeutic potential of our pipeline and to transform the treatment landscape for many individuals living with brain health disorders.
Robert Barrow: With that I'd like to thank you all again for joining us today and I'm happy to take any questions.
Operator: Thank you so much. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A list. Our first question comes from Rudy Lee from Lear Inc. Partners. Your line is open.
Speaker Change: Thank you so much at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced soon.
Speaker Change: Draw. Your question. Please press Star one one again please.
Operator: Please standby, while we compile the Q&A roster.
Operator: Okay.
Rudy Lee: Our first question comes from <unk> from Leerink Partners. Your line is open.
Rudy Lee: Hi, Thanks for taking my question congrats on the progress.
Rudy Lee: So like those just announced that the FDA is hosting an AD comm meeting.
Rudy Lee: <unk> therapy in PTSD. So can you maybe talk about the implications too and then 120 and just curious what are the key topic that you were looking at for.
Operator: For this meeting.
Robert Barrow: Yeah, thanks so much, Rudy. I'll start it off and then certainly invite Dr. Karlin to comment as well. We certainly, I think, as a field and we as a company expected an advisory committee for any first intern in a drug class. I think it's important to draw a clear distinction between the mechanism of action, the methods of how MDMA is administered in LICO's clinical program for PTSD, and the distinct way in which MM120 is being developed and studied.
Operator: <unk>.
Rudy Lee: Yes, thanks, so much for it.
Robert Barrow: Started last winter by Dr Carlo to comment as well.
Robert Barrow: We certainly I think as the field and we are accompanying expected Advisory Committee.
Robert Barrow: Any first entrant drug classic it's important to draw a clear distinction between the mechanism of action with the message.
Robert Barrow: Our MDMA is administered mycosis clinical program for PTSD and distinct way in which <unk> is being developed in study, but generally we would expect there to be an advisory committee for novel treatments such as that so.
Robert Barrow: But generally, we would expect there to be an advisory committee for novel treatments such as this. So I think there's been some commentary publicly trying to read into this, and I don't think there's much to be read into for all of us across the board if you don't expect it.
Robert Barrow: I think there has been some commentary publicly we're trying to read and the desktop and also if there is much to be read into in all of its across the board in a few unexpected to be occurring.
Robert Barrow: In terms of subject matters that we'll be following very closely and looking to understand points of interest for the advisory committee, we've seen the ICER report on LICO's program. We have intentionally, from day one, designed our program to address many of the key questions that have been presented in our field, and they're covered in FDA guidance, and I feel very confident that we will continue to demonstrate the best in class scientific rigor and approach to addressing those questions. But certainly, we'll follow the areas of interest from the advisory committee members and look forward to, hopefully, a successful outcome for Lycos and MDMA. Thanks, super helpful.
Robert Barrow: In terms of subject matter. So it will be following very closely and looking to understand.
Robert Barrow: Of interest for the Advisory Committee that we have seen the ISO report.
Robert Barrow: Unlike us program.
Robert Barrow: We have intentionally from from day, one designed our program to answer many of the key question that had been presented Mirfield that are covered in the guidance.
Robert Barrow: Feel very confident that we will continue to demonstrate some of the best in class.
Robert Barrow: Scientific rigor on our approach to addressing those questions, but certainly will follow with the area of interest from.
Robert Barrow: Committee members and look forward to hopefully a successful outcome for.
Robert Barrow: For Iqos and MDMA.
Robert Barrow: Thanks Super helpful.
Robert Barrow: Sure.
Operator: Thank you. Please stand by. Our next question comes from Brian Abrahams from RBC Capital Markets. Your line is open.
Speaker Change: Thank you please standby.
Operator: Our next question comes from Brian Abrahams from RBC capital markets. Your line is open.
Brian Corey Abrahams: Hi, good afternoon. Thanks for taking my questions. In the recent APA presentation, you showed some trends over time in both HAMA and PGIS, and it looked like, directionally, they were similar, but maybe there were some subtle differences there.
Brian Corey Abrahams: Hi, good afternoon, thanks for taking my questions.
Brian Corey Abrahams: At the recent.
Brian Corey Abrahams: Presentation.
Brian Corey Abrahams: You showed.
Brian Corey Abrahams: Some trends over time in both MAA and TGIF and it looked like.
Brian Corey Abrahams: Directionally they were similar but maybe there were some subtle differences. There I was wondering if you could talk about that and just I guess, how that's impacting what your base cases here for the durability of it.
Robert Barrow: I was wondering if you could talk about that and just, I guess, how that's impacting what your base case is here for the durability of the administration based on both this and other evolving data. And then, secondarily, I think the mattress change here really underscores what could be potential antidepressive effects. And so I know you sort of alluded to it a little bit in the prepared remarks, but I'd be curious to hear what specific, more specifically, what some of the factors that you guys are going to be considering in determining whether or not to move this forward in major depressive disorder or other depression indications, and I guess how you're thinking about the potential. Indications might be there. Thanks.
Robert Barrow: Of the administration.
Robert Barrow: Based on this and other.
Robert Barrow: Evolving data and then secondarily I think.
Robert Barrow: The mattress change here I think really underscores.
Robert Barrow: What could be potential anti depressive effect, and so I know you've sort of alluded to it a little bit in the prepared remarks, but I'd be curious to hear what specific more specifically what some of the factors that you guys are going to be considering.
Robert Barrow: In determining whether or not to move this forward.
Robert Barrow: In major depressive disorder, or other depression indications and I guess, how youre thinking about what the potential.
Robert Barrow: Okay.
Robert Barrow: Indications might be there.
Daniel Rollings Karlin: Perfect. Thanks so much, Brian. I'll turn it over to Dan to talk about your first question, then I'll maybe address the second.
Speaker Change: Perfect. Thanks, so much Brian.
Daniel Rollings Karlin: Ill turn it over to Dan to talk about your first question and then I'll maybe address the second one Dan.
Daniel Rollings Karlin: Yeah, absolutely, and thanks so much for the question. So, you know, when we look across all of the different measure data that we've shown publicly so far, what we see is directional agreement and, to a very large extent, magnitude agreement as well. So, in general, each of these different scales gives us confidence in the different domains that they pick up that the effect we're seeing is real, and is not an artifact of one particular scale or one particular method of administering a scale.
Speaker Change: Absolutely and thanks. Thanks, so much for the question. So when we look across all of the different measure data that we've shown.
Daniel Rollings Karlin: Publicly so far what we see is directional.
Daniel Rollings Karlin: And two.
Daniel Rollings Karlin: Two a very large extent magnitude agreement as well so.
Daniel Rollings Karlin: In general each of these different skills gives us confidence in the different domains that they pick up the.
Daniel Rollings Karlin: The effect, we're seeing is real is not an artifact of one particular gather one for Julie method of administering a scale.
Daniel Rollings Karlin: Of course, a CGI collected by a blinded radar is going to reflect slightly different things than a PGI that may be more determined by a patient's individual experience in the treatment. But the fact that we're seeing slight degradation on the PGI at week 12 doesn't give us any concerns about the robust activity of the drug, particularly since we're seeing such strong significance across the clinician-rated measures.
Daniel Rollings Karlin: Of course, the CGI collected by <unk>.
Daniel Rollings Karlin: Blinded rater is going to reflect slightly different things in our pgi that there may be more determined by a patient's individual experience in the treatment, but particularly the fact that we're seeing.
Daniel Rollings Karlin: We 12 slight degradation on the Pgi doesn't give us any concerns about the robust activity of the drug, particularly since we're seeing such strong significance across the clinician rated.
Robert Barrow: I'm Rob. Do you want to speak to me at my address?
Daniel Rollings Karlin: Measures.
Daniel Rollings Karlin: Rob do you want to speak to matters you want me to.
Robert Barrow: Yeah, absolutely. Thanks so much, Dan.
Rob: Yes, absolutely.
Robert Barrow: And I would just note, too, on that first point, Brian, that obviously the HAM-A anxiety scale is the gold standard for any sort of anxiety approval, so that's where we're going to be focused in our dialogue with FDA. You know, again, while we talk about the pairwise comparisons here, we have to remember that it was a large 200 patient study. We had robust power and statistical conclusions on the HAM-A.
Robert Barrow: Thanks, So much Dan and I would just note too on that first point Brian.
Robert Barrow: They havent thank guys scale.
Robert Barrow: The gold standard for Internet anxiety approvals, so thats, where were going to be focused in our dialogue with FDA.
Robert Barrow: Yes.
Robert Barrow: While we talk about the power IC passenger you have to remember that he was the large 200 patient study, we had robust power and statistical conclusions on on the Ham a.
Robert Barrow: So then we're looking at secondary endpoints and looking at pairwise comparisons. We're talking about, you know, around 40 patients per arm in the phase two study. So that has progressed. And look at the numerical changes.
Robert Barrow: Some of them are looking at secondary endpoint looking at pairwise comparisons were talking about.
Robert Barrow: Around 40 patients per arm the phase II studies.
Robert Barrow: And looking at the numerical changes ebitdas will be.
Robert Barrow: Likely to be statistically significant if we saw the same effects in a larger population.
Robert Barrow: Even those would be likely to be statistically significant if we saw the same effects in a larger population. In terms of the depression indication, something we've alluded to and spoken about before publicly, which is that we're actively assessing additional indications. I think as we look at the landscape in psychiatry and really look at the promise of this drug class and the kind of magnitude that we believe we can achieve in terms of really changing the direction of what we've talked about a lot, which is the epidemic of brain health and mental health in this country.
Robert Barrow: In terms of the depression indication.
Robert Barrow: We've alluded to and spoken about before publicly which is.
Robert Barrow: We're actively assessing just want indications I think as we look at the landscape in psychiatry and you really look at the promise of this drug class and that kind of magnitude that we believe we can achieve in terms of really changing the direction of what we have.
Robert Barrow: Talked about a lot of the epidemic.
Robert Barrow: Brain health and mental health in the country.
Robert Barrow: Depression and anxiety have such a strong overlap and interplay, and looking at major depressive disorder and other related indications makes quite a bit of sense, of course, as we think about getting this drug in the hands of clinicians and making sure it has the opportunity for the broadest impact and broadest uptake. So we'll provide guidance at the right point in time if and when we come to a determination on the exact indication and clinical development plans for any substance.
Robert Barrow: Depression, and anxiety have such a strong overlap in interplay.
Robert Barrow: Looking at maybe a depressive disorder.
Robert Barrow: Other related indications.
Robert Barrow: It makes quite a bit of a sense of course, we think about.
Robert Barrow: Getting the starting in the hands of clinicians and making sure it has.
Robert Barrow: The opportunity for the broadest impact and Brian its uptake so.
Robert Barrow: We'll provide guidance at the right point in time, if and when we come to a determination on the exact.
Robert Barrow: Indications in clinical development plan for any subsequent.
Robert Barrow: Clinical indications. Something, you know, obviously with the Madras scores, it'd be, it's hard. It's hard to overlook the magnitude of response we saw to the potential antidepressant effects in our phase two study, building that on top of a prior study from our colleagues showing a 16 week durable effect. Page PAGE of NUMPAGES www.verbalink.com Thanks so much.
Robert Barrow: Clinical indications.
Robert Barrow: Obviously with the major scores.
Robert Barrow: It's hard.
Robert Barrow: It's hard to overlook the magnitude of response we've.
Robert Barrow: We entered the price on the back of our Phase II study.
Robert Barrow: That on top.
Robert Barrow: Certainly from our colleagues showing a 16 week durable effect.
Robert Barrow: In major depressive disorder, I guess, there's obviously.
Robert Barrow: We think an opportunity there.
Robert Barrow: Looking at very closely and giving further guidance on future.
Speaker Change: Got it thanks, so much.
Operator: Thank you. Please stand by. Our next question comes from Charles Duncan from Cantor. Your line is open.
Speaker Change: Thank you please standby.
Operator: Okay.
Operator: Our next question comes from Charles Duncan from Canaccord. Your line is open.
Charles Cliff Duncan: Hi, this is Elaine on behalf of Charles. Thank you for taking my questions. Just going back to your presentation at APA, I'm just curious, what feedback did you receive? For the KOLs, was the 12-week durability the most important? And also, what was the perception of improvement in matters? And I have a follow-up question on 402.
Operator: Hi, This is lane on for Charles Thank you for taking my questions.
Charles Cliff Duncan: Just going back to your presentation at EPA I'm, just curious what feedback we received.
Charles Cliff Duncan: What the Kols was the Toby durability. The most important and also what was the perception towards the improvement in matters.
Charles Cliff Duncan: I have a follow up on the <unk> channel.
Robert Barrow: Thanks so much, Elaine. Now I'll turn it over to Dan to address that one as well. Yeah, thanks.
Charles Cliff Duncan: Thanks, So much and now I'll turn it turn it over to Dan address that one as well.
Daniel Rollings Karlin: Yeah, thanks, Elaine. You know, we get feedback of all different types, and certainly, different folks are focused on different aspects of efficacy. I think for clinicians who are on the ground treating people with GAD, the rapidity of effects, so the fact that we saw strong clinically significant and statistically significant changes on scales that are measurable as soon as day two was particularly notable. And then, of course, the durability, as you suggested. There are folks who look at this and take those two in combination to say that it really does look like we are eliciting a rapid and durable drug effect So across the board, very warmly received, and folks are appropriately excited to see the data.
Dan: Thanks Helane.
Daniel Rollings Karlin: We get.
Daniel Rollings Karlin: Feedback of all different types and certainly different folks are focused on different aspects of the efficacy.
Daniel Rollings Karlin: I think for clinicians who are who are on.
Daniel Rollings Karlin: On the ground treating people with with JD.
Daniel Rollings Karlin: <unk> of effects. So the fact that we saw.
Daniel Rollings Karlin: Strong clinically significant and statistically significant changes on scales that are measurable as soon as day too.
Daniel Rollings Karlin: This was particularly notable and then of course the durability. As you suggested there are folks who look at this and take those two in combination to say that it really does look like we are eliciting a rapid and durable drug effect, which is unlike other tools that folks have available to them. So so.
Daniel Rollings Karlin: Across the board very warmly received and folks are appropriately excited to see these data.
Robert Barrow: Hey, father, thank you. And for 402, pending a favorable PK profile and tolerability from the phase one trial, what do you anticipate 402's target product profile to be for ASD?
Daniel Rollings Karlin: Yeah.
Speaker Change: Thank you and for 402 pending favorable PK profile and Tolerability from the phase one trial.
Speaker Change: What do you envision <unk> target product profile for <unk>.
Speaker Change: For amcor.
Robert Barrow: Yeah, at a high level, certainly with no approved therapies to treat core symptoms of autism spectrum disorder, the ultimate goal here is to have a regularly administered treatment that would aid in the core symptoms and social communication deficits in autism. The analogy we like to draw often is the equivalent of how psychostimulants are used to treat ADHD, such that while the drug is having its pharmacological effects, patients are able to better focus and better participate in activities.
Speaker Change: Yes at a high level certainly with no approved therapies to treat course at the Washington spectrum disorder. The ultimate goal here is to have a regularly administered treatment that would aid in the of course it doesn't communique.
Robert Barrow: Communication deficits in autism, the analogy, we'd like to draw Austin is.
Robert Barrow: The equivalent of how cycles stimulants are used to treat ADHD such debt.
Robert Barrow: The drug is having a pharmacological effects.
Robert Barrow: It looks like the stimulus patients are able to better focus better within a participating occupations and the same would apply.
Robert Barrow: And the same would apply, obviously, through different mechanisms and targeting a different disorder. But in autism, the social communication deficits, the core of autism that the FDA patient workshops have described as the target for pharmacological intervention in autism are social communication deficits, the very things that so the rachemic MGMA and we believe, potentially, RMDMA will aid in as well. So the ultimate product profile would be a regularly administered product that would aid in an individual's social communication abilities and would allow them to more readily participate in their daily activities.
Robert Barrow: I think two different mechanisms.
Robert Barrow: We're getting a different disorder.
Robert Barrow: The social communication to exit the core of autism and met the FDA.
Robert Barrow: Patient workshops and describe as the target for pharmacological intervention and autism, our social communications, the very things that.
Robert Barrow: So the racemic MDMA and.
Robert Barrow: We believe essentially RMA.
Robert Barrow: As well so.
Robert Barrow: The ultimate product profile would be regularly administered product that would aid and individuals social communication.
Robert Barrow: Abilities and would allow them to.
Robert Barrow: More readily participate in there.
Robert Barrow: Danny occupations.
Robert Barrow: Got it. Very helpful. Thank you for taking our questions. Thanks for tuning in. See you next time.
Robert Barrow: Got it. Very helpful. Thank you for taking our call.
Speaker Change: Got it very helpful. Thank you for taking our question.
Speaker Change: Thanks Helane.
Speaker Change: Thank you.
Operator: Our next question comes from Frank Biswa.
Robert Barrow: Our next question comes from Frank This swap.
Frank Biswa: Hi, this is Dan on behalf of Frank. Thanks for taking our questions. Firstly, with regard to the planned Phase 3, could you give us some color on how you're thinking about the design of that study? Any similarities or differences to the Phase 2B, and specifically, does the Zytus ODT formulations PK?
Frank Biswa: Your line is open.
Operator: Hi, This is Dan on for Frank Thanks for taking our questions.
Frank Biswa: Firstly with regard to the planned phase III could you give us some color on how you're thinking about the design of that study any similarities or differences to the phase.
Frank Biswa: <unk> and specifically does the <unk> ODT formulations PK.
Frank Biswa: Impact the phase III design anyway.
Robert Barrow: Yeah, thanks so much, Dan. In terms of the planned phase three studies, we're going to reserve some final determination of the protocols until we have our end of phase two meeting and reach complete alignment with the agency on the path forward to those pivotal studies. But given our interactions to date, we certainly feel we have a high degree of understanding of the right approach there.
Speaker Change: Yes, thanks, so much Dan so in.
Robert Barrow: In terms of a fan phase III studies that we're going to reserve a final determination of the protocols until.
Robert Barrow: We have our interface to median reached in complete alignment with the agency on the path forwards as pivotal studies, but.
Robert Barrow: Even our interactions to date, we certainly feel we have a high degree of understanding what the right approach there.
Robert Barrow: And by and large, the phase three clinical trials will be extremely similar, if not virtually identical, to our phase two clinical trial design. With the exception that we intend to go forward with for purposes of the statistical comparisons and the overall design, comparing 100 micrograms of ODTs, as you mentioned, to a placebo. The ODT formulation, in and of itself, has no impact. Designing the Phase 3 program, we were really encouraged by the PK bridging results and from what we've seen in that study, both quantitatively in the results reported, but also qualitatively in talking to the investigators in that Phase 1 study, but believe that certainly going forward, the 100 microgram dose is optimal in our view, and we're particularly encouraged about the prospects as we go into that clinical trial.
Robert Barrow: <unk>.
Robert Barrow: By and large that the phase III clinical trials will be.
Robert Barrow: Extremely similar if not virtually identical to our phase two clinical trial design with the exception that we intend to go forward with.
Robert Barrow: For purposes of the comparisons in the overall design comparing 100 microgram Odt's that you mentioned.
Robert Barrow: Placebo.
Robert Barrow: ODT formulation in of itself has no impact on the design of the Phase III program, we were really encouraged by the PK bridging results in.
Robert Barrow: From what we've seen in that study bus quantitatively in the results we reported but also qualitatively and report talking to the investigators in that phase one study bill.
Robert Barrow: Leave it.
Robert Barrow: Certainly going forward 100 microgram dose.
Robert Barrow: Optum on our view and we're particularly encouraged about the prospects as we go into that clinical trial.
Robert Barrow: No impact in terms of study design, but.
Robert Barrow: Even our conviction about the clinical potential of that formulation.
Robert Barrow: Thanks, that's helpful. Just one quick one. The new epidemiological data that was presented at APA, could you talk about the GAD-7 screening tool, how it could potentially, if it's being used in the next trials, and any learnings regarding the market opportunity in GAD based on that new data? Thanks.
Speaker Change: Thanks, that's helpful. Just.
Robert Barrow: One quick one the new epidemiological data that was presented at <unk> could you talk about the.
Robert Barrow: The GAAP <unk> cleaning tool, how that's potentially if that's being used in the next trials and any learnings regarding the market opportunity in <unk> based on that new data.
Robert Barrow: Yes.
Robert Barrow: Yeah, I'll mention it first and then turn it back over to Dan to talk perhaps about the clinical utility of that, of GAD-7. We certainly are going to be using GAD-7 and the open-label portion of our Phase III program to screen patients for potential retreatment. So after our 12-week double-blind period, patients will have the opportunity to roll it over into a nine-month open-label study where they'll be screened, and then if symptoms of GAD are present, they'll have the opportunity for retreatment.
Speaker Change: Yes, I'll answer that first and then turn it back over to Dan <unk>.
Dan: Clinical utility of that once again Jonathan.
Dan: We certainly are going to be using the guide seven and the open label portion of our phase III program to screen patients for potential re treatment. So after a 12 week double blind period patients will have the opportunity to roll it over into a nine month open label study, where they'll be screened and then if symptoms of J D.
Robert Barrow: One of the things we've observed in all the epidemiological data and the disease burden in our pharmacoeconomic research is that one of the most costly patient populations are patients who have GAD symptoms but haven't yet received a diagnosis of GHB, and also patients who have received a diagnosis of J.D. and have severe disease. As it turns out, the vast majority of patients with J.D. have moderate to severe disease, in part because the treatments we have available today are not particularly well suited to treating anxiety.
Dan: The opportunity for re treatment.
Robert Barrow: One of the things we've observed.
Robert Barrow: And all of the epidemiological data and the disease burden and are frankly, our economic research is that one of the most costly patients.
Robert Barrow: Patient populations are patients who have symptoms, but haven't yet received the diagnosis of J D.
Robert Barrow: And also patients who have received guidance of J D.
Robert Barrow: Severe disease as it turns out.
Robert Barrow: The vast majority of patients with J D have moderate to severe disease in part because the treatments available today or are not particularly well suited to treating anxiety.
Robert Barrow: But certainly we'll be we'll be looking at Gantt-Webinar Phase 3 program. And given the underdiagnosis of GAD, we believe the, both the tool will become an important tool in the toolbox of finding these patients out in the real world, but also that there's a really massive opportunity that's been underappreciated by payers, by providers, and certainly by patients who go many years without a diagnosis and that USPSTF's recommendation for using the GAD7 for screening going forward really, all of this provides kind of a tailwind for what we expect to be the pickup of the overall prevalence of GED.
Robert Barrow: But certainly we'll be we'll be looking at Gaslog and our phase III program and given the under diagnosis of.
Robert Barrow: We believe the.
Robert Barrow: Both the tool will become an important tool.
Robert Barrow: Cool.
Robert Barrow: In the toolbox of finding these patients got real world, but also that there is a really massive opportunity that's been underappreciated by payers by providers and certainly by patients who go many years about a diagnosis.
Robert Barrow: <unk> recommendation for you can get seven for screening going forward really.
Robert Barrow: Now all of this provides.
Robert Barrow: Kind of a tailwind so what we expect to be the pickup.
Robert Barrow: The overall prevalence of JV.
Robert Barrow: Ultimately a larger population of patients, we hope to be able to help.
Robert Barrow: Dan I'll turn it over to you if you haven't been to add on the clinical utility of the <unk>, yes. So I mean, what we learned from this epidemiological work with that.
Daniel Rollings Karlin: Yeah, so what we learned from this epidemiological work was that, as we assumed, this is an underdiagnosed condition. So despite its high diagnosed prevalence, in this particular study, just over 23% of respondents had a positive screen on the GAD-7, and just over 80% of those folks didn't have a diagnosis or had never been diagnosed with GAD. We learned a bit about the healthcare utilization of these folks who are walking around, likely with GAD, but with undiagnosed GAD. And obviously, it has a tremendous impact on individual well-being, individual distress, but also on healthcare costs and costs to employers as well.
Daniel Rollings Karlin: As we assumed this is an under diagnosed condition. So despite its high diagnosed prevalence.
Daniel Rollings Karlin: This particular study just over 23% of respondents had a positive screen on the <unk> seven and just over 80% of those who didn't have a diagnosis had never been diagnosed with J D.
Daniel Rollings Karlin: We learned a bit about the healthcare utilization of these folks were walking around likely with JD, but with undiagnosed.
Daniel Rollings Karlin: And obviously has a tremendous impact on individual will be individual distress, but also on.
Daniel Rollings Karlin: Health care costs and cost to employers as well.
Daniel Rollings Karlin: What all this adds up to is that it's further evidence in support of the USPSTF recommendations from the past year that folks really ought to be screened. So the GAD-7 is the equivalent, essentially, for anxiety disorders of the PHQ-9 for depressive disorders. PHQ-9 has been used more and more frequently over the past 30 years to pick up depressive disorders, some at the expense of anxiety disorders. And so we are strongly supportive of screening for anxiety disorders in primary care settings and other healthcare settings.
Daniel Rollings Karlin: What all this adds up to is that it's further evidence in support of the USPS TF recommendations from the past year.
Daniel Rollings Karlin: Folks really ought to be screened so again, 7%.
Daniel Rollings Karlin: Is the equivalent essentially for anxiety disorders of the Peach Q nine for depressive disorders.
Daniel Rollings Karlin: <unk> has been used.
Daniel Rollings Karlin: More and more frequently over the past 30 years to 25. This year is to pick up depressive disorders that someone can be expensive anxiety disorders and so.
Daniel Rollings Karlin: We are strongly supportive of.
Daniel Rollings Karlin: Screening for anxiety disorders in primary care settings, and other health care settings.
Daniel Rollings Karlin: And what ends up being reflected in the data about the current environment is that folks who weren't diagnosed tend to be younger, so in the end, what is likely happening is that people develop anxiety symptoms in their 20s or early 30s and then go 10, 15, 20 years walking around in distress without getting a diagnosis, and as a result of not being diagnosed, being unable to be treated. And so we continue to believe that people benefit from early screening and intervention that gets to the disorder and gets to treatment earlier in the course of illness before comorbidities and other impacts of the illness accumulate.
Daniel Rollings Karlin: What ends up being reflected in the data about the current environment is that.
Daniel Rollings Karlin: Folks who were diagnosed.
Daniel Rollings Karlin: Tend to be younger so that in the end what is likely happening is that people developing <unk> symptoms.
Daniel Rollings Karlin: In their Twenty's early thirties, and then go at.
Daniel Rollings Karlin: 10, 15, 20 years walking around even distressed without getting a diagnosis and as a result of not being diagnosed not being able to be treated and so.
Daniel Rollings Karlin: We continue to believe that people will benefit from from early screening and intervention that gets to that day.
Daniel Rollings Karlin: Order and gets to treatment earlier in the course of illness before comorbidities and other.
Daniel Rollings Karlin: Impacts would be on this accumulate.
Robert Barrow: Thank you. That's very helpful. Thanks for taking my questions. Thank you.
Daniel Rollings Karlin: Okay.
Speaker Change: Thank you that's very helpful. Thanks for taking my questions.
Operator: Thank you. One moment for our next question. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Our next question comes from Sumant Kulkarni from Canaccord Genuity, LLC. Your line is open.
Robert Barrow: Okay.
Speaker Change: Thank you one moment for our next question.
Operator: As a reminder to ask a question you will need to press star one one on your telephone and wait.
Operator: Your name to be announced to withdraw your question. Please press star one again.
Sumant Satchidanand Kulkarni: Our next question comes from Newmont Kulkarni from Canaccord Genuity LLC. Your line is open.
Sumant Satchidanand Kulkarni: Good afternoon. Thanks for taking my question. So, what are your latest thoughts on potentially developing MM120 for depression? And would that be a program that the organization is ready to run simultaneously with a pivotal program in GAD and other things you're doing on 402? Or are you focusing on GAD with undivided attention until you get more clarity on trial results?
Speaker Change: Good afternoon, and thanks for taking my question. So what are your latest thoughts on potentially developing and then 120 for depression and would that be a program that the organization is ready to run simultaneously with the pivotal program in <unk> and other things youre being on photo too or are you focusing on GE David's undivided attention until you get more clarity on trial design.
Robert Barrow: Yeah, thanks so much, Sumant. Yeah, no, as mentioned earlier, we certainly are taking a very hard look at the market dynamics and the opportunity for depression and related indications. You know, we have built the company really from the ground up over the past three years and have done so all along the way with the ability to, with an eye, of course, to executing on physical development programs, but also with the ability to take on multiple programs far beyond what's currently in our pipeline.
Speaker Change: Yes, thanks, so much demand.
Robert Barrow: Yes.
Robert Barrow: As mentioned earlier, we certainly are taking a very hard look at the market dynamics and the opportunity in depression and related indications.
Robert Barrow: We have built the company really from the ground up over the past three years.
Robert Barrow: I have done so all along the way with the ability to.
Robert Barrow: With an eye of course executing on pivotal development programs, but also.
Robert Barrow: Ability to take on multiple programs.
Robert Barrow: So, the infrastructure and our team and our ability to operationalize multiple programs, the pipeline has been something we've been working towards and doing over the past several years. And so, we certainly believe and expect that we'll be in a position to execute on multiple clinical indications, potentially in parallel. Now, we never lose focus on our furthest along asset, the furthest along program, which is, of course, M120 and GAD, but even as we've conceived of operationalizing other indications, like, for instance, potentially in depression, there are many operational efficiencies and quite a bit of overlap.
Robert Barrow: And whats currently in our pipeline.
Robert Barrow: The infrastructure of our team and our ability to execute operationalized mulch.
Robert Barrow: Multiple programs in the pipeline has been something we've been working towards and have been doing over the past several years.
Robert Barrow: And so we certainly believe in.
Robert Barrow: And.
Robert Barrow: It will be in a position to execute on our multiple.
Robert Barrow: Clinical indication.
Robert Barrow: In parallel.
Robert Barrow: We never lose focus on our furthest along asset the French long program, which is of course, an inland <unk> and JD, but even as we have conceived of operationalize in other indications like for instance, potentially in depression.
Robert Barrow: There are many operational efficiencies and quite a bit of overlap so well.
Robert Barrow: So, we'll be in a position to give further guidance if and when we decide to launch a program in a second indication with 120, but based on our team's abilities and, certainly, the existing evidence, I believe there's opportunity in depression and a number of other indications in brain health.
Robert Barrow: We will be in a position to give further guidance and then we decided to launch a program in the second indication with 120.
Robert Barrow: But based on our team's abilities and based on certainly the existing evidence believe there is opportunity in depression, and a number of other indications right.
Robert Barrow: And as a follow-up, as you plan to hold your End of Phase II meeting with the FDA, where do you think the most potential for differences between what you might propose versus the FDA's potential outlook might be?
Robert Barrow: Right now.
Robert Barrow: Got it and as a follow up as you plan to hold your end of phase two meeting with the FDA, where do you think the most potential for differences between what you might propose versus the fda's potential outlook might be.
Robert Barrow: Yeah, I wouldn't want to speak for the agency. I think, you know, we obviously try to avoid any sort of regulatory interaction. And we very much appreciate it, and, you know, it's easily said, but it's very much true. And I've had the privilege of working with the agency and the division on this drug class over the past five or so years. And we know they've been extremely thoughtful and extremely productive. And, you know, there are always nuanced in a drug development program, but we certainly listen to the conversation, the dialogue we've had in the past, follow the guidance, and try to make logical, rational, scientific arguments for when there's any sort of I'd be reluctant to speak for FDA and say where we would expect there to be some particular points of discussion, but by and large Got it. Thank you.
Robert Barrow: I wouldn't want to speak for the agency I think we obviously try to go into any sort of regulatory interactions.
Robert Barrow: Very much.
Speaker Change: I appreciate it and then.
Robert Barrow: It's easily said, but it is very much true and I've had the privilege of working with the agency in this division on this drug class over the past fiber.
Robert Barrow: So years then.
Robert Barrow: We know there has been extremely thoughtful extremely productive and.
Robert Barrow: There's always nuances in <unk> drug development program, but.
Robert Barrow: We certainly listen to the conversation the dialogue we've had in the past followed the guidance I'm.
Robert Barrow: I'm trying to make logical rational scientific arguments for.
Robert Barrow: When there is any sort of.
Robert Barrow: Yes.
Robert Barrow: The particular view that needs to be discussed or hashed out so.
Robert Barrow: I'd be reluctant to speak for FDA and they were we would expect there to be some.
Robert Barrow: Some particular points of discussion but.
Robert Barrow: By and large I think.
Robert Barrow: We view FDA is very much as a partner in this and have had very constructive dialog date and expect that to continue that going into phase III.
Speaker Change: Got it thank you.
Operator: Please stand by for our next question. Our next question comes from Elemer Piros from Rodman. Your line is open.
Speaker Change: Please standby for our next question.
Operator: Okay.
Elemer Piros: Our next question comes from LMR hereof from Rodman Your line is open.
Elemer Piros: Yes, good afternoon. Rob, I'd like to talk a little bit, if you wouldn't mind addressing how heavily pretreated the phase 2b population was. And in the commercial setting, once we get there, where do you see MM120 being used, especially considering that there is a large population that is undiagnosed and without treatment? Where would MM120 fit in, based on your phase 2b trial, your phase 3 design, once you read the FDA?
Elemer Piros: Yes, good afternoon.
Elemer Piros: Rob I'd like to talk a little bit if you would you mind addressing how heavily pretreated.
Elemer Piros: And the phase two b population was.
Elemer Piros: And in the commercial setting once we get there.
Elemer Piros: Where do you see and then one plenty being used especially considering that there is a large population is under diagnosed.
Elemer Piros: Without treatment neighborhood, and then one plenty sit in.
Elemer Piros: Based on your phase two B trial your phase III.
Elemer Piros: Design once you agreed with the FDA et cetera.
Robert Barrow: Yeah, thanks so much, Elmer. So, I'll take the second part of the question first, which is to say, when we conceive of where MM120 could fit in the real world in clinical practice, I think as a field, there's been some limited views on the opportunity and the concept that these therapies could only be reserved for the most severe patients who have failed everything else. And what we're really seeing over and over in the clinical data is that there seems to be a sort of trajectory change.
Rob: Yes, thanks, so much Albert so.
Speaker Change: Ill take your second part of your question first which is to say when we conceive of where.
Robert Barrow: 120 could fit in.
Robert Barrow: Real World clinical practice.
Robert Barrow: I think as a field theres been somewhat of a constraining us of skus on the opportunity.
Robert Barrow: Concept.
Robert Barrow: These therapies could only be reserved for the most severe patients who have failed everything else then.
Robert Barrow: What we're really seeing over and over and the clinical data is that there seems to be a sort of trajectory change and so NGA Dia in particular, what we observe is that patients who go undiagnosed and <unk> have severe JD end up spending years.
Robert Barrow: And so in GAD in particular, what we observe is that patients who go undiagnosed and or have severe GAD end up spending years, simply because they have failed everything else. Now, that is not to say that we expect, and we're going to be marketing this as a first-line therapy, per se. We obviously are going to be focused in our commercial activities and certainly believe there is enormous value to be gained by focusing on patients who have failed prior treatments and who have severe disease.
Robert Barrow: Going to the Doctor having other other related.
Robert Barrow: Comorbidities in there.
Robert Barrow: A huge impact on their quality of life and also a huge impact on the health care system now where the value also comes from when we talk about reimbursement and we talked about.
Robert Barrow: The burden on the health care system from a financial point of view.
Robert Barrow: In those patients who go undiagnosed, who have severe JD, but walk around not knowing that they have severe J D and so we actually see the opportunity is far more expansive than simply the patients who have failed everything else now that is not to say that we expect are going to be.
Robert Barrow: Marketing as a first line therapy per se.
Robert Barrow: We obviously are going to be focused in our commercial.
Robert Barrow: Activities until they believe there is enormous value to be gained by focusing on the patient.
Robert Barrow: Prior treatments and you had severe disease, but.
Robert Barrow: But we certainly believe there's a likelihood that patients who are not at the end of their treatment course and have failed everything else could potentially benefit. And that really also aligns with the data we've been able to generate. Now, we see a nice mix that is largely representative of the real-world population in our clinical trials. And so, certainly, a significant portion of the patients have prior treatments and have failed numerous prior treatments.
Robert Barrow: We certainly believe there is a likelihood that patients who.
Robert Barrow: Or not at the end of actually my question that failed everything else could potentially benefit.
Robert Barrow: Yes that really also aligns with the data we've been able to generate now we see a nice mix that largely representative of.
Robert Barrow: The real world population in our clinical trials and so certainly a significant portion of the patients had a prior treatments have failed numerous prior treatments. When we look at license of the data we don't see a meaningful difference between response regardless.
Robert Barrow: When we look at slices of the data, we don't see a meaningful difference between response regardless of treatment history, which, again, I think in depression, there's a much better definition of treatment resistance and focus on these last-line patients. But in GAD, it's somewhat of a different dynamic that we think is more favorable both from a business standpoint and from a clinical impact standpoint.
Robert Barrow: The history, which.
Robert Barrow: I think in depression is a much better definition of treatment resistant.
Robert Barrow: We focus on only those last nine patients but in.
Robert Barrow: Somewhat of a different dynamic that we think is more favorable both of them.
Robert Barrow: Business standpoint and from.
Robert Barrow: Yeah, and do you think that there is a difference between the journey of a patient newly diagnosed, then tried different sorts of medications whose primary diagnosis is depression as opposed to GAD? And if you could address, you know, what sort of physicians of one versus the other would see before they get some significant help, if ever?
Robert Barrow: Our clinical impact standpoint.
Robert Barrow: Yes.
Robert Barrow: And do you think that there is a difference between the journey.
Robert Barrow: The patient.
Robert Barrow: Newly diagnosed then.
Robert Barrow: Tried different sort of medications in.
Robert Barrow: Primary diagnosis is depression as opposed to the JV.
Robert Barrow: If you could address what sort of physicians.
Robert Barrow: One versus the other would see.
Robert Barrow: Before they get some significant help if ever.
Robert Barrow: I'll turn that over to Dan to maybe address initially.
Robert Barrow: Yeah, happy to try to address it, and I think it's a really good question about the patient journey. I think what we have to remember when we think about the differences between MDD and GAD is that while they are very much overlapping diagnoses, MDD is episodic. It's a cyclical illness with periods of depression interspersed with periods of euthymia or normal mood. And so folks falling into a state change going from their sort of usual state into a depressed state may be more likely to seek care earlier in the course of the illness.
Speaker Change: Yeah happy to try to address and I think it's a really good question about the patient journey I think what we have to remember when we think about the differences between <unk> and <unk> is that while they are very much overlapping diagnoses MTBE is is episodic it's a cyclical illness with periods of.
Robert Barrow: Depression interspersed with periods of time are normal mood.
Robert Barrow: And so folks falling into falling into a state change going from their sort of usual state into a depressed state.
Robert Barrow: Maybe more likely to seek care earlier in the course of the illness.
Robert Barrow: And you know, what we're seeing as we dive deeper and deeper into the epidemiology of anxiety disorders and GAD is that the insidious nature of the onset of GAD may lead folks to be seeking care later to sort of acclimate to this new way of feeling, and even though they're in distress, not necessarily see it as a target that they would want to raise with a clinician. With both of these conditions, the patient journey very often starts with primary care.
Robert Barrow: What we're seeing as we dive deeper and deeper into the epidemiology of anxiety disorders, and <unk> is that the insidious nature of the onset of Gd may lead folks to be seeking care later to sort of.
Robert Barrow: Acclimate to this new way of feeling even though they are in distress not necessarily see it as a target that they would want to raise with a clinician with both of these conditions. The patient journey very often starts with primary care.
Robert Barrow: Their folks have more contact with their primary care doctors if they're not regularly seeing a psychiatrist or other psychiatric provider. And often, first-line treatments are given at the level of primary care, again, partly due to the availability of specialty psychiatric providers. Patterns are driven by treatment ability. It was the commonality, the frequent prescribing, and the familiarity with SRIs that brought them into the primary care setting in a way that previous antidepressants maybe weren't as comfortable.
Robert Barrow: They're folks have more contact with their primary care doctors, if theyre not regularly seeing a psychiatrist scrubbers psychiatry provider and often first line treatments are given at the level of primary care again, partly due to availability of specialties psychiatric providers.
Robert Barrow: Who can prescribe so things like Ssris as a starting point moved toward primary care for both depression, and anxiety or depressive and anxiety disorders.
Robert Barrow: As folks.
Robert Barrow: Show themselves to either be more severe or to be more.
Robert Barrow: Resistant to treatment not sustained benefit or intolerable side effects with first line treatments is generally when folks entered the psychiatric care system.
Robert Barrow: What we know is that these patterns are driven by treatment availability.
Robert Barrow: The commonality the frequent prescribing the familiarity with ssris that brought them into the primary care setting in a way that previous.
Robert Barrow: Antidepressants, maybe weren't as comfortable for primary care doctors that may arise in things like Tricyclics, which are which are more difficult to prescribe and so while we can reflect on the current.
Robert Barrow: Patterns of care journeys of care, where people are getting what sorts of care the availability of a different treatment changes those patterns and so while we absolutely think about how things happened today, we're also very much oriented toward.
Robert Barrow: Creating a world that is built to an extent around what we're able to bring to bear on these disorders.
Robert Barrow: Then just a little follow-up here if you don't mind. Some people believe that a psychedelic medicine treatment would only be prescribed by a doctor.
Speaker Change: And then just a little follow up here, if you don't mind.
Robert Barrow: Some people believe that.
Robert Barrow: Hey, if I could Doug medicine treatment would only be prescribed.
Robert Barrow: By a specialist.
Robert Barrow: Aye.
Speaker Change: I'm not sure.
Robert Barrow: Because after all.
Robert Barrow: General practitioner or specialties youre not going to administer these therapies. They are going to be administered that specialized centers, so youre not going to be necessarily directly involved.
Robert Barrow: In the actual treatment.
Speaker Change: Do you agree or disagree with this line of thought.
Robert Barrow: I think there are parts of that that we absolutely agree with, and other parts we might push back on a bit, so that the sorts of prescribers who are comfortable prescribing any given medication will have everything to do with the sorts of data we're able to generate around efficacy and safety in appropriate patient populations, appropriate assessments for pre-prescribing, and that in many cases, perhaps the prescriber, the prescribing health care provider, will There are many.
Speaker Change: I think there are parts of that we absolutely agree with another parts, we might pushback kind of it so that the sorts of prescribers, who are comfortable prescribing any given medication will have everything to do with the sorts of data, we're able to generate around efficacy and safety in appropriate patient populations appropriate assessments for.
Robert Barrow: Pre prescribing and it in many cases, perhaps the prescribed they are.
Robert Barrow: Prescribing health care provider will be affiliated with or possibly even involved with the actual administration of medicine, possibly with the help of lower level providers there.
Robert Barrow: Any cases, we can imagine with the prescriber and the ultimate.
Robert Barrow: Session monitoring may not even be affiliated with one another that.
Robert Barrow: We identified individually and niche while what we've seen for interventional psychiatry today.
Robert Barrow: Is largely centered around specialty centers. This has to do as much with the need for physiological monitoring and medical certification as it does with actual safety and appropriateness of location.
Robert Barrow: We didn't see physiological liability in phase two b.
Robert Barrow: Which we believe will begin to open up the possibility that we can build a body of evidence that the types of places where <unk> can be safely administered might be significantly broader than specialized centers. So.
Robert Barrow: Very much considering a range of options for who could be the potential prescribers and who could be the potential session monitors.
Speaker Change: Thank you very much.
Speaker Change: Dan I'm going to add one comment on top of that element, which is that it.
Robert Barrow: I think one of the things we repeatedly you want to make sure is fully appreciated.
Robert Barrow: The scale of the potential opportunity here and the fact that just because treatment practices today with the tools in the toolbox of practitioners.
Robert Barrow: We live in a world, where only sri's, primarily are administered and they're often build out versus primary care.
Robert Barrow: It's easy for observers of that market to start to say, well, that's the only way it can be done. And really, what we're talking about is a sort of transformational change, both at a patient level because of the magnitude and the durability of the response we're able to generate, but also at a level of medical practice where we can actually start to think about having these new tools really reshape the ability to have meaningful impact on patients and, in so doing, opening up potential opportunities such that this isn't relegated to
Robert Barrow: It's easy for observers of that market to start to say well that's the only way it can be done and really what we're talking about is that sort of transformational change both at a patient level because of the magnitude and the durability of response, we're able to generate but also at a level of medical practice, where we can actually start to think about having these these new.
Robert Barrow: Tools really reshaped the ability to have meaningful impact on patient and so doing opening up the potential opportunity such that this isn't relegated to.
Robert Barrow: , , , , , , , , , , , , , , a very last line of treatment where no one can access it because they have to have gone to a psychiatrist for five years before they're eligible. We see that as too constrained of a view here and believe that there's a need for a much larger opportunity or a need for a much larger view of how we can have a meaningful impact.
Robert Barrow: Yes.
Robert Barrow: Very last line of treatment, where no one can access that you currently have gone to a psychiatrist for five years.
Robert Barrow: Before they're eligible we see that as too constrained or a view here I believe that there is.
Robert Barrow: Our need for a much larger opportunity or it means very much larger.
Robert Barrow: View of how we can have a meaningful impact.
Robert Barrow: Yeah, may I just add one other aspect, and I'm sure that a specialist, a psychiatrist, spent a lot of time managing the side effects or managing titrating those drugs or replacing them with another one. We don't have this issue with MM120, do we?
Robert Barrow: Yes.
Robert Barrow: Just add one other aspect that I am sure that a specialist a psychiatrist spent a lot of time to manage the side effects or managed tight trading.
Robert Barrow: Those drugs or replacing with another one.
Robert Barrow: You don't have this issue of it <unk> Dolby.
Robert Barrow: That's exactly right. I'll say, obviously Dan is a practicing psychiatrist. That said, you know, when we talk to KOLs, One of the things that we hear over and over again is the excitement around a drug with a high degree, in relative terms, of clinical remission that we're able to achieve, and the fact that those results are driven by both the rapidity and durability of effects, such that patient walks in the door with SRIs, as you mentioned, Elemer, patient is going to be given the drug and it's going to take a number of weeks before there's an expected clinical benefit.
Speaker Change: That's exactly right.
Robert Barrow: Oh, yes.
Robert Barrow: Yes.
Speaker Change: I'll say I'll just add.
Robert Barrow: Dan practicing psychiatrist that said.
Robert Barrow: When we talk to Kols.
Robert Barrow: One of the things that we hear over and over again, the excitement around a drug with a.
Robert Barrow: A high degree relative terms of clinical remission were able to achieve and the fact that those results are driven by both the rapidity and durability of effect such that patient walks in the door.
Robert Barrow: With US right as you mentioned down there.
Robert Barrow: Patient is going to be given drug and it's going to take a number of weeks for political mix expected clinical benefit and over that time is when we see the adverse events side effects of the drug already occurring.
Robert Barrow: And over that time, we see the adverse events, the side effects of the drug already occurring. Here, what we're seeing is such a rapid response that a follow-up within a couple of days is largely indicative of where the patient, at least in our study so far, is going to be months later. In large part, if they achieve remission, they seem to stay in remission. And so that kind of clinical clarity early in the treatment course is something that is highly desirable for providers and something that we have been very excited to see in our data.
Robert Barrow: Here, what we're seeing in such a rapid response.
Robert Barrow: A follow up with them a couple of days is largely indicative of where the patients at least in our study. So far is going to be months later in March.
Robert Barrow: If they ever achieve remission.
Robert Barrow: Seem to stay and readmission and so that kind of clinical clarity early in the treatment of course at some point.
Robert Barrow: Hi, desirability from providers and something that we've.
Robert Barrow: Yeah, but you forgot to mention the headache the next morning.
Robert Barrow: I'm very excited to see in our data.
Speaker Change: Yes, but you forgot to mention the headache, the next morning.
Robert Barrow: Well, there are lots of things that are worse for you that give you a headache the next morning. So we feel very comfortable with the physiological profile.
Robert Barrow: Okay.
Speaker Change: Well, there's lots of things that are worse for you that gives you a headache. The next morning.
Speaker Change: Alright very comfortable.
Speaker Change: So profile.
Speaker Change: Thank you.
Robert Barrow: Kober
Robert Barrow: Yeah.
Operator: Thank you. One moment for our next question. Our next question comes from Patrick Trucchio from H.C. Wainwright and Company. Your line is open.
Speaker Change: Thanks Omar.
Speaker Change: Thank you one moment for our next question.
Patrick Ralph Trucchio: Our next question comes from Patrick <unk> from HC Wainwright <unk> Company. Your line is open.
Patrick Ralph Trucchio: Thanks. Good afternoon.
Patrick Ralph Trucchio: Thanks, Good afternoon, I have a couple of follow up questions. The first is on the new dermatological data presented EPA.
Robert Barrow: I have a couple of follow-up questions. The first is on the new epidemiological data presented at APA. Just in terms of the potential impact on commercialization of MM120 and GAD7, I'm wondering if you can talk about the prospect or possibility of having this validated GAD7 screening tool more widely deployed in the real world healthcare setting as part of this potential commercialization. Secondly, whether this data itself is helpful or can be built upon as part of health economic outcomes research, or is there some other use for it that could be beneficial for the potential launch of
Patrick Ralph Trucchio: In terms of the potential impact on commercialization.
Robert Barrow: <unk> hundred 20, and Judy I'm wondering if you can talk about.
Robert Barrow: Aspect the possibility of having this validated JD <unk> screening tool more widely deployed in the real World Health care setting as part of this potential commercialization and secondly, if the state itself is helpful or can be built upon as part of health economic outcomes research or is there. Some other use for it that could be beneficial for the potential launch.
Robert Barrow: Mm 120.
Robert Barrow: And then separately just theres some UHD data upcoming.
Robert Barrow: And then separately, just, you know, there's some UHB data upcoming. So I was wondering, first, what potential read-through regarding durability of treatment we should expect from the Phase II UHB data being presented at the Society of Biological Psychiatry and whether or not findings in that study could impact discussions with the FDA regarding the MM120 Phase III program. In what way could that data maybe be helpful to you?
Robert Barrow: I was wondering first if you can give us an idea of potential reapproved regarding durability of treatment. We should expect from the phase III <unk> data being presented sorry, biological psychiatry, and whether or not finding within that study could impact discussions with the FDA regarding the <unk> phase III program and wait for that data maybe it'd be helpful to you.
Robert Barrow: And then separately, regarding MM402, can you talk about the potential read-through from the UHB Phase I trial to your program and how you think about, you know, next steps for MM402 and ASD, assuming a positive outcome from your SAB study?
Robert Barrow: And then separately regarding <unk> Porto too can you talk about potential read through from the <unk>.
Robert Barrow: Phase one trial to your program and how you think about next steps for unemployed the Q&A ft, assuming a positive outcome from your Stat study.
Robert Barrow: Yeah, thanks so much, Patrick. I'll try to take these one by one.
Speaker Change: Yes, thanks, so much Patrick I'll try to take these one by one so certainly in terms of the prevalence, although we've been talking about the under diagnosis of.
Robert Barrow: So certainly, in terms of the prevalence, you know, although we've been talking about the underdiagnosis of That obviously has a huge impact from a health and societal level, but from a market opportunity perspective, it means that the market may be orders of magnitude larger than we're expecting based on current epidemiological data. And that aligns with certainly what we hear. Potential read through of the UHB study. As we look back over the past couple of years, we initially had investigator-initiated data on lysogide, again, different dose and regimen, but that demonstrated durable effects out to really about six months after treatment for patients who got LSD or lysogide first.
Robert Barrow: The fact that there is a tool that can.
Robert Barrow: We believe validly pick up.
Robert Barrow: This is yet to be diagnosed the fact that that is now being recommended for implementation and has not been fully implemented suggest to us that really what we're seeing in terms of the current epidemiological data is just the tip of the iceberg.
Robert Barrow: Market is actually much much larger than we're seeing in the statistics today or from the last several years.
Robert Barrow: That obviously.
Robert Barrow: A huge.
Robert Barrow: Impact from it.
Robert Barrow: Our health and societal level, but from a market opportunity of course.
Robert Barrow: The market may be.
Robert Barrow: Orders of magnitude larger than we're expecting based on current epidemiological data and that aligns with certainly what we hear.
Robert Barrow: And here from clinical practitioners.
Robert Barrow: We absolutely actively are working on AUR.
Robert Barrow: How is the economics research to quantify.
Robert Barrow: The scale and the scope of the impact that we can ultimately see here to demonstrate the value proposition to all of the key stakeholders, who are going to need to be aligned to enable the broad uptake of our products. So.
Robert Barrow: Something we are actively engaged and have a really talented group.
Robert Barrow: He is working on that.
Robert Barrow: Potential read through of the <unk> study.
Robert Barrow: And in this study, we now have follow-up even further with those patients. So as we've conceived of the phase two results that we were able to achieve, we've also seen, largely in terms of HAM-A scores, a sort of flatlining where we didn't see a regression back to baseline or worsening of symptoms on average over time. And so if we ultimately are seeing those effects, granted, in investigator-initiated smaller studies, but if those are effects that are shown to be durable for many months longer, I think one can only think it bodes well for the potential of what we'll be able to demonstrate as we go forward into longer studies like our open-label studies that are planned for phase three.
Robert Barrow: Certainly.
Robert Barrow: As we look back over the past couple of years. We initially had investigator initiated data on laser diode again different dosing regimens, but the demonstrated the durable.
Robert Barrow: Effects out too.
Robert Barrow: Really about six six months after treatment patients who've got LSD or license first and in this study we now have a follow up even further with those patients. So as we have conceived of the phase II results, we were able to achieve we've also seen.
Robert Barrow: Largely in terms of handmade.
Robert Barrow: EMEA scores.
Robert Barrow: Sort of Flatlining or we didn't see a regression back to baseline or worsening incentives on average over time and so if we ultimately are seeing those effects.
Robert Barrow: Granted an investigator initiated smaller studies, but if those are effects. They are starting to be durable for many months longer I think once all I think it bodes well for the potential of what we'll be able to demonstrate as we go forward into longer.
Robert Barrow: And similarly, with MN-402, of course, it's very difficult to have read-through from a healthy volunteer population into a But, you know, again, it's hard to we don't want to overextend the interpretation of healthy volunteer data. And we talked about going into phase two and later research.
Robert Barrow: Things like our open label study, it's paying for phase III.
Robert Barrow: And familiar with and then part two of course, it's very difficult to have read through from the healthy volunteer popular.
Robert Barrow: That's helpful. Thank you very much.
Robert Barrow: Population.
Robert Barrow: Disordered population in terms of results from a phase one study.
Robert Barrow: But certainly the understanding what will have in terms of the some of the mechanisms underlying the activity has been referred to the demonstration of.
Robert Barrow: Tolerability and sort of the AE profile that we'll be able to report out and observed.
Robert Barrow: For two up to doses of 250 milligrams will be its certainly encouraging dressed and it won't be informative as we continue to design our program but.
Robert Barrow: Again, it's hard to.
Robert Barrow: We don't want to overextend the interpretation of healthy volunteer data when we talked about going in to phase III and later research.
Robert Barrow: That's helpful. Thank you very much.
Speaker Change: Thanks, Patrick.
Operator: I am showing no further questions at this time. That does conclude our question and answer session. Thank you for your participation in today's conference. This does conclude our program. You may now disconnect.
Speaker Change: Thank you.
Speaker Change: I am showing no further questions at this time that does conclude our question and answer session. Thank.
Operator: Thank you for your participation in today's conference. This does conclude our program you may now disconnect.
Operator: Okay.
Operator: [music].
Operator: Yes.
Operator: [music].