Q2 2024 Mind Medicine (MindMed) Inc Earnings Call

August 13, 2024

[music].

Operator: Good morning, and welcome to the Mind Medicine second quarter 2024 financial results and corporate update conference call. Currently, all participants are in a listen-only mode. This call is being webcast live on the investors and media section of MindMed's website at mindmed.co, and a recording will be available after the call. I would now like to introduce Rob Barrow, CEO of MindMed. Please go ahead.

Operator: Good morning, and welcome to the MindMedicine second quarter 2024 financial results and corporate update conference call. Currently, all participants are in a listen-only mode.

Good morning, and welcome to the mine Medicine second quarter, four financial results and corporate update conference call.

Speaker Change: All participants are in a listen only mode.

Operator: This call is being webcast live on the Investors & Media section of MindMed's website at MindMed.co, and a recording will be available after the call. I would now like to introduce Rob Barrow, CEO of MindMed. Please go ahead.

Speaker Change: This call is being webcast live on the investors and media.

Speaker Change: In our mind that's website at my net dot com and a recording will be available after the call.

Speaker Change: I would now like to introduce Rob Garo G. L mind, Matt. Please go ahead.

Robert Barrow: Thank you, and good morning, everyone. Welcome to our second quarter 2024 Financial Results and Corporate Update Conference Call. Today, we will be sharing highlights from the second quarter, along with the significant progress we've made with plans for our Phase 3 program in Generalizing Anxiety Disorder, or GAD. Additionally, I'm excited to share further specifics about the expansion of our R&D program for MM120 into Major Depressive Disorder, or MDD, both of which are further supported by the financing we announced last week.

Robert Barrow: Thank you, and good morning, everyone. Welcome to our second quarter 2024 Financial Results and Corporate Update conference call. Today, we will be sharing highlights from the second quarter, along with the significant progress we've made with plans for our Phase 3 program in Generalizing Anxiety Disorder, or GAD. Additionally, I am excited to share further specifics about the expansion of our R&D program for MM120 into Major Depressive Disorder, or MDD, both of which are further supported by the financing we announced last week.

Speaker Change: Thank you and good morning, everyone.

Speaker Change: Welcome to our second quarter 2024 financial results and corporate update conference call.

Speaker Change: Today, we will be sharing highlights from the second quarter, along with the significant progress we've made with plans for our phase III program in generalized anxiety disorder or <unk>.

Speaker Change: Additionally, I'm excited to share further specifics about the expansion of our R&D program for it and then one 'twenty into major depressive disorder or MPD both.

Speaker Change: Of which are further supported by the financing we announced last week.

Robert Barrow: The press release reporting our financial results and the presentation we will be using on today's call are both available in the Investors and Media section of our website. And our quarterly report on Form 10-Q for the quarter ended June 30, 2024, was filed this morning with the Securities and Exchange Commission.

Speaker Change: The press release reporting our financial results and the presentation, we'll be using for todays call are both available in the investors and media section of our website.

Speaker Change: Quarterly report on Form 10-Q for the quarter ended June 32024 was filed this morning with the Securities and Exchange Commission.

Unknown Executive: During today's call, and as outlined on slide two, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and our future expectations, plans, partnerships, and prospects. These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes.

Speaker Change: During today's call.

Speaker Change: Outlined on slide two we will be making certain forward looking statements, including without limitation statements about the potential safety efficacy and regulatory and clinical progress of our product candidates, our anticipated cash runway and our future expectations plans partnerships and prospect.

Speaker Change: These statements are subject to various risks such as changes in market condition difficulties associated with research and development regulatory approval processes.

Unknown Executive: 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 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 with the SEC or other significant events occurring outside of MindMed's normal course of business.

Speaker Change: These and other risk factors are described in our filings made with the SEC, including our annual report on Form 10-K, and our Form 10-Q filed today.

Unknown Executive: 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 filed today. Forward-looking statements are based on the assumptions, opinions, and estimates of management at the date statements are made, including the non-occurrence of the risks and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of MindMed's normal course of business.

Speaker Change: Forward looking statements are based on the assumption opinion and estimate good management.

What's are made including the non occurrence of the risks and uncertainties described in our filings made with the SEC or other significant event occurring outside of my normal course of business.

Unknown Executive: You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, August 13, 2024. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law.

Unknown Executive: Please be careful not to place undue reliance on these forward-looking statements, which are made as of today, August 13, 2024. MindMed disclaims any obligation to update such statements, even if management's views change, except as required by law.

Speaker Change: You are cautioned not to place undue reliance on these forward looking statements, which are made as of today August 13 2024.

<unk> disclaims any obligation to update such statements, even if management's views change except as required by law.

Robert Barrow: Let me begin by taking you through today's agenda on slide three. I'll start with our Q2 2024 business update, and then Dr. Dan Karlin, our Chief Medical Officer, will join to discuss our R&D plans for MM120 Oral Disintegrating Tablet, or ODD, in GAD and MGD. We are also pleased to be joined by Dr. Reid Robison, Senior Principal Investigator, Cedar Clinical Research, and Adjunct Faculty at the University of Utah. Dr. Robison is an investigator in our MN 120 clinical development, and he'll provide his views on our phase three clinical trial. Following Dr. Robison, I'll discuss our second quarter financial highlights.

Robert Barrow: Let me begin by taking you through today's agenda on slide three. I'll start with our Q2 2024 business update, and then Dr. Dan Karlin, our Chief Medical Officer, will join to discuss our R&D plans for MN120 Oral Disintegrating Tablet, or ODD, in GAD and MDD. We are also pleased to be joined by Dr. Reid Robison, Senior Principal Investigator, Cedar Clinical Research, and Adjunct Faculty at the University of Utah. Dr. Robison is an investigator in our MN 120 clinical development, and he'll provide his views on our phase three clinical trial. Following Dr. Robison, I'll discuss our second quarter financial highlights.

Speaker Change: Let me begin by taking you through today's agenda on slide three.

Speaker Change: I'll start with our Q2 2020 for a business update and then Dr. Dan Perlin, our Chief Medical Officer, who joined to discuss our R&D plans for and then 120 oral disintegrating tablet or ODT N. G E D. M D D.

Speaker Change: We're also pleased to be joined by Dr. Reed Robertson senior principal investigator Cedar clinical research and adjunct faculty at the University of Utah.

Speaker Change: Dr. Robinson as an investigator led 120 clinical development program.

Speaker Change: His views on our phase III clinical trials.

Speaker Change: Following Dr. Robinson, I'll discuss our second quarter financial highlights Gary anticipated upcoming milestones and then we'll conclude with a Q&A session.

Robert Barrow: Here are our anticipated upcoming milestones. And then we'll conclude with a Q&A session, where we will also be joined by Dr. Francois Leventhal, our Chief Commercial Officer, to answer your questions. On slide four, I'm pleased to share our progress for the quarter and for the first half of the year. In June, we successfully completed a constructive end to phase 2 meeting with the US Food and Drug Administration, which supports the advancement of MM120 into pivotal phase 3 clinical trials for GAD.

Robert Barrow: Here are our anticipated upcoming milestones, and then we'll conclude with a Q&A session, where we will also be joined by Dr. Francois Leventhal, our Chief Commercial Officer, to answer your questions. On slide four, I'm pleased to share our progress for the quarter and for the first half of the year. In June, we successfully completed a constructive end to phase two meeting with the US Food and Drug Administration, which supports the advancement of MM120 into pivotal phase three clinical trials for GAD.

Francois Lebel: Also be joined by Dr. Francois Lebel, our chief commercial officer to answer your questions.

Speaker Change: On slide four I'm pleased to share our progress for the quarter and for the first half of the year.

Speaker Change: In June we successfully completed a constructive end of phase two meeting the U S food and drug administration was.

It was the first year.

Speaker Change: 121, pivotal phase III clinical trials for J D.

Robert Barrow: We are on track to initiate our first phase 3 trial for MN120ODT and GAD in the second half of 2024, which marks a major milestone in our development program. We're also excited to share with you our plans to expand our R&D program for MN 120 into MDD with the initiation of the eMERGE study, a registrational clinical trial for MN120ODT and MDD, which we expect to initiate in the first half of 2025.

Robert Barrow: We are on track to initiate our first phase three trial for MIM-120-ODT and GAD in the second half of 2024, which marks a major milestone in our development program. We are also excited to share with you our plans to expand our R&D program for MM120 into MDD with the initiation of the eMERGE study, a registrational clinical trial for MM120 ODD and MDD, which we expect to initiate in the first half of 2025.

Speaker Change: We are on track to initiate our first phase III trial for mm 120, <unk> and <unk> in the second half of 2024, which marks a major milestone in our development program.

Speaker Change: We are also excited to share with you our plans to expand our R&D program and then 120th M. D D.

Speaker Change: The investigation of the emerge study a registrational clinical trial, and then one 'twenty ODT MDT.

Speaker Change: We expect to be understand in the first half of 2025.

Robert Barrow: We also expect to conduct a second registrational study in MDD, with the study design and timing to be informed by the eMERGE study and additional regulatory discussions. The scope and sequencing of our clinical program for MN120 and MDD are being carefully executed to balance the exciting opportunity represented by MDD while maintaining a cash runway into 2027. With this approach, we believe our cash runway will be sufficient to support operations for at least 12 months beyond our first phase three readout in G8.

Speaker Change: We also expect to conduct a second Registrational study in <unk> with the study design and timing to be informed by the emerge study and additional regulatory discussion.

Speaker Change: The scope and sequencing of our clinical program for <unk>, and then $120 MTT is being carefully executed without the exciting opportunity represented by entity, while maintaining a cash runway into 2027.

Speaker Change: With this approach we believe our cash runway will be sufficient to support operations for at least 12 months beyond our first phase III readout and J D.

Robert Barrow: In June, we announced the U.S. Patent and Trademark Office issued a new patent covering the formulation and manufacturing methods of MM120-OD that extends our intellectual property protection for MN 120 ODT through 2041, providing further runway for potential commercialization. We have also seen continued progress with our second lead program, MM402, which is our proprietary form of the R enantiomer of MDMA. We are currently evaluating MM402 in a Phase I single ascending dose trial in healthy adults intended to characterize tolerability, pharmacokinetics, and pharmacodynamics.

Robert Barrow: In June, we announced the U.S. Patent and Trademark Office issued a new patent covering the formulation and manufacturing methods of MM120-ODE that extends our intellectual property protection for MN 120 ODP through 2041, providing further runway for potential commercialization. We have also seen continued progress with our second lead program, MM402, which is our proprietary form of the R enantiomer of MDMA. We are currently evaluating MM402 in a Phase I single ascending dose trial in healthy adults intended to characterize tolerability, pharmacokinetics, and pharmacodynamics.

Speaker Change: In June we are now.

Speaker Change: The U S patent and trademark office issued a new patent covering the formulation and manufacturing methods and then once <unk> ODT.

Speaker Change: Extender intellectual property protection, and then one 'twenty ODT through 2041.

Speaker Change: Providing further runway for potential commercialization.

Speaker Change: We are also seeing continued progress with our second lead program and then <unk>, which is our proprietary form of the R enantiomer of MDMA.

Speaker Change: We are currently evaluating <unk> in a phase one single ascending dose trial in healthy adults.

Speaker Change: Tended to characterize Tolerability pharmacokinetics and pharmacodynamics.

Robert Barrow: We expect that the results from this trial will enable further clinical trials to characterize the effects of repeated daily doses of M402 and the exploration of early signs of efficacy in the autism spectrum disorder population. Lastly, I'm pleased to report that we just completed a successful underwritten public audit, raising approximately $75 million in gross proceeds before deducting transaction fees and other offering-related expenses.

Speaker Change: We expect results from this trial will enable further clinical trials to characterize the attacker repeat at daily doses and for it to you and the exploration early signs of efficacy.

Speaker Change: This inspection disorder population.

Speaker Change: Lastly, I'm pleased to report that we just completed a successful underwritten public offering raising approximately $75 million of gross proceeds before deducting transaction fees and other offering related expenses.

Robert Barrow: Based on our current operating plans, we believe that the proceeds from this offering, in addition to our cash and cash equivalents as of June 30, 2024, will extend our cash runway into 2027, at least 12 months beyond our first phase three clinical readout in GAD. Importantly, this funding demonstrates continued enthusiasm for our programs and strategy and allows us to rapidly advance MM120 in both GAD and MDD. Here on slide five is a look at our pipeline of three clinical stage programs, including our phase three trials for MM120 and GAD and MDD.

Robert Barrow: Based on our current operating plans, we believe that the proceeds from this offering, in addition to our cash and cash equivalents as of June 30, 2024, will extend our cash runway into 2027, at least 12 months beyond our first phase three clinical readout in GAD. Importantly, this funding demonstrates continued enthusiasm for our programs and strategy and allows us to rapidly advance MN 120 in both GAD and MDD. Here on slide five is a look at our pipeline of three clinical stage programs, including our phase three trials for MM120 and GAD and NDD.

Speaker Change: Based on our current operating plans, we believe that the proceeds from this offering in addition to our cash and cash equivalents as of June 32024 extends our cash runway into 2027 at least 12 months beyond our first phase III clinical readout and J D.

Speaker Change: Importantly, this funding demonstrates continued enthusiasm towards our programs and strategy allows us to rapidly advance and then 120 and both JD and MTBE.

Speaker Change: Here on slide five if you look at our pipeline of three clinical stage programs, including our phase III trials for <unk>.

Speaker Change: 120, <unk> and NTT.

Robert Barrow: As I mentioned, we remain on track to initiate the Pivotal Phase III program for MN 120 and GAD in the second half of 2024, and we intend to initiate the first registrational study in our newly announced MDD program in the first half of 2025. As detailed on slide 6, MM120 has shown significant potential for addressing large unmet needs in brain health disorders. Our Phase 2b trial for MM120 and GAD demonstrated an effect size more than double that of the standard of care and a 48% remission rate 12 weeks after a single dose. We also observed significant, rapid, and durable effects on comorbid depression symptoms in GAD patients. In the U.S. alone, there are 20 million adults with J.D.

Speaker Change: As I mentioned, we remain on track to initiate the pivotal phase III program, and then 120 <unk> in the second half of 2024, and we intend to initiate the first Registrational study and our newly announced <unk> program in the first half of 2025.

Robert Barrow: As detailed on slide 6, MM120 has shown significant potential for addressing large unmet needs in brain health disorders. Our Phase 2b trial for MM120 and GAD demonstrated an effect size more than double that of the standard of care and a 48% remission rate 12 weeks after a single dose. We also observed significant, rapid, and durable effects on comorbid depression symptoms in GAD patients. In the U.S. alone, there are 20 million adults with J.D.

As detailed on slide six and then 120 has shown significant potential in addressing the large unmet need with brain health disorders.

Speaker Change: Our phase <unk> trials, and then once <unk> demonstrated an effect size more than double that of the standard of care and a 48% remission rate 12 weeks after a single dose.

Speaker Change: We also observed significant rapid durable effects on comorbid depression symptoms and ghd patients.

Robert Barrow: and 31 million adults with M.D. Of these, $13 million and $18 million are treated annually for GAD and MDD, respectively. These two markets represent a substantial opportunity for effective treatment. We believe that if approved, MM120 could offer patients a differentiating and compelling option in both GAD and MDD, which could position it to become a best-in-class treatment option targeting two of the biggest market opportunities in psychiatry. Slide 7 outlines our overall program for MN-120 in GAD and MDD, which incorporates constructive feedback from our recently completed end-of-phase 2 meetings with FDA. In the coming quarters, we anticipate initiating three registrational studies across the GAD and MDD programs, including the Voyage and Panorama Studies in GAD and the Emerge Study in MDD.

Robert Barrow: and 31 million adults with M.D. Of these, $13 million and $18 million are treated annually for GAD and MDD, respectively. These two markets represent a substantial opportunity for effective treatment. We believe that if approved, MM120 could offer patients a differentiating and compelling option in both GAD and MDD, which could position it to become a best-in-class treatment option targeting two of the biggest market opportunities in psychiatry. Slide 7 outlines our overall program for MM120 in GAD and MDD, which incorporates constructive feedback from our recently completed End-of-Phase II meetings with FDA. In the coming quarters, we anticipate initiating three registrational studies across the GAD and MDD programs, including the voyage and panorama studies in GAD and the eMERGE study in MDD.

Speaker Change: In the U S alone there are 20 million adults with JD and 31 million adults with MTT.

Speaker Change: Of the $13 billion and 18 million are treated annually for JD MDT, respectively.

Speaker Change: These two markets represent a substantial opportunity for effective treatments.

Speaker Change: We believe that if approved and then 122 also a patient a differentiated and compelling option on both JD and MDT, which could position it.

Speaker Change: <unk> best in class treatment option targeting two of the biggest market opportunities in psychiatry.

Speaker Change: Slide seven outlines our overall program for Am 120, <unk> and NTT, which incorporates constructive feedback from our recently completed and the phase two meeting with FDA.

Speaker Change: In the coming quarters, we anticipate initiating three registrational studies across the Gi DMD programs, including the voyage and Panorama study, even JD in the emerge study and MDT.

Robert Barrow: The initiation of pivotal studies for NM120 truly represents a major milestone for MindMed as we strive to become a leader in developing novel treatments to address brain health disorders. Before turning the call over to Dan to go over the details and designs of our Phase 3 study, I want to take a minute to address our approach to some of the major topics that have come into focus since the FDA Pharmacologic Drug Advisory Committee meeting earlier this year and FDA's recent decision on Lyco Therapeutics' application for MDMA-assisted therapy for PTSD. Our development strategy outlined on slide eight is rigorous and thoughtful and continues to be appreciated by regulators, researchers, clinicians, and research participants. We believe this will ultimately translate into confidence for patients and prescribers.

The initiation of pivotal studies, and then 120 truly represents a major milestone for <unk> as.

Speaker Change: As we strive to become a leader in developing novel treatments to address brain health disorders.

Speaker Change: Before turning the call over to Dan to go over the details in design for our Phase III studies.

Speaker Change: I wanted to take a minute to address our approach.

So some of the major topics that have come into focus since the FDA Pharmacologic drugs Advisory Committee meeting earlier this year and Fda's recent decision. Unlike.

Unlike our therapeutics application MDMA therapy for PTSD.

Robert Barrow: Our development strategy outlined on slide eight is rigorous and thoughtful and continues to be appreciated by regulators, researchers, clinicians, and research participants. We believe this will ultimately translate into confidence for patients and prescribers. Specifically, we have implemented several strategies to address key methodological considerations in this drug class, including the use of central radars blinded to both treatment assignment and visit number, the inclusion of expectancy and blinding questions, but perhaps most importantly, the elimination of psychotherapeutic intervention in our clinical trials. Additionally, our approach to safety monitoring follows well-established industry best practices.

Dan: Our development strategy outlined on slide eight is rigorous and thoughtful and continues to be appreciated by regulators researchers clinicians and research participants.

Dan: We believe this will ultimately translate the consequence for patients and prescribers.

Robert Barrow: Specifically, we have implemented several strategies to address key methodological considerations in this drug class, including the use of central raters blinded to both treatment assignment and visit number, the inclusion of an expectancy and blinding questionnaire, and perhaps most importantly, the elimination of psychotherapeutic intervention in our clinical trials. Additionally, our approach to safety monitoring follows well-established industry best practices.

Dan: Specifically, we have implemented several strategies to address key methodological considerations in this drug class.

Dan: Including the use of central raters blinded to both treatment assignment and visit number.

Dan: The inclusion of expectancy and wining questionnaires.

Dan: Perhaps most importantly, the elimination of psychotherapeutic intervention in our clinical trials.

Dan: Additionally, our approach to safety monitoring how is well established industry best practices in both of our phase III clinical trials and dedicated clinical pharmacology trials, we intend to fully robustly characterize safety on 'twenty.

Robert Barrow: In both of our Phase III clinical trials and dedicated clinical pharmacology trials, we intend to fully and robustly characterize the safety of MN120. Our development of MM120 has been carefully designed to adhere to the highest clinical and ethical standards in alignment with FDA guidelines. We believe that our well-designed Phase IIb trial for MN120 and GAD demonstrated compelling tolerability in the FPC data that exceeds today's standard of care. Additionally, we continue to publish scientific research backed by the robustness of our clinical data and our increasing body of evidence for MM120's potential as an emerging best-in-class product candidate, along with the growing unmet need to treat patients suffering from GAD, MDD, and other brain health disorders.

Daniel Karlin: In both of our Phase III clinical trials and dedicated clinical pharmacology trials, we intend to fully and robustly characterize the safety of MN120. Our development of MM120 has been carefully designed to adhere to the highest clinical ethical standards in alignment with FDA guidelines. We believe that our well-designed Phase IIb trial for MN120 and GAD demonstrated compelling tolerability and efficacy data that exceeds today's standard of care. Additionally, we continue to publish scientific research, backed by the robustness of our clinical data and our increasing body of evidence for MM120's potential as an emerging best-in-class product candidate, along with the growing unmet need to treat patients suffering from GAD, MDD, and other brain health disorders.

Dan: Our development of <unk>, and then 120th some carefully designed with share to the highest clinical ethical standards alignment with FDA guidance.

Dan: We believe that our well designed phase <unk> trials, and then 120 <unk> demonstrated compelling tolerability and efficacy data it exceeds today's standard of care.

Dan: Additionally, we continue to publish scientific research backed by the robustness of our clinical data and our increasing body of evidence for <unk> potential as an emerging best in class product candidate along with a growing unmet need to treat patients suffering from J D and didi and other brain health disorders.

Daniel Karlin: As we embark on our pivotal development programs for MN-120, we remain both appreciative and excited by FDA's commitment to advancing research for the psychedelic drug class. This has been exemplified through FDA's recent public statements in which they indicated they continue to encourage research and drug development that will further innovation for psychedelics. In addition to the high degree of engagement and partnership that we have experienced in numerous interactions with the FDA over the course of the year, now, I'd like to turn the call over to Dr. Dan Karlin, our Chief Medical Officer, to discuss our clinical development programs in detail. Dan?

Robert Barrow: As we embark on our pivotal development programs for MN-120, we remain both appreciative and excited by FDA's commitment to advancing research for the psychedelic drug class. This has been exemplified both through FDA's recent public statements in which they indicated that they continue to encourage research and drug development that will further innovation for psychedelics, in addition to the high degree of engagement and partnership that we have experienced in numerous interactions with the FDA over the course of the year. Now, I'd like to turn the call over to Dr. Dan Karlin, our Chief Medical Officer, to discuss our clinical development programs in detail. Dan

Dan: As we embark on our pivotal development programs and then 120, we remain both appreciative and excited by Fda's commitment to advancing research for the <unk> drug class.

Dan: This has been exemplified both through FDA recent public statements, which they indicated they continue to encourage research and drug development that will further innovation for psychedelic triples.

Dan: In addition to the high degree of engagement and partnership that we have experienced numerous interactions with FDA over the course of the year.

Speaker Change: Now I'd like to turn the call over to Dr. Dan Carlin, our Chief Medical Officer.

Our clinical development programs in detail.

Daniel Karlin: Thank you, Rob. Turning to slide 10. We believe MM120 has the potential to address large unmet needs in major brain health disorders based on the compelling results we shared from our phase two trial for MM120-MGAD. In this trial, we observed a rapid onset of effect with a 1.8 point reduction in clinical global impressions severity, or CGIS, within 24 hours in participants treated with 100 micrograms, which was highly statistically significant, with a p-value less than

Daniel Karlin: Thank you, Rob. Turning to slide 10. We believe MM120 has the potential to address large unmet needs in major brain health disorders, based on the compelling results we shared from our phase two trial for MM120 and GAD. In this trial, we observed a rapid onset of effect with a 1.8 point reduction in clinical global impressions severity, or CGIS, within 24 hours in participants treated with 100 micrograms, which was highly statistically significant, with a p-value less than 0.0001.

Speaker Change: Dan.

Dan Carlin: Thank you Rob turning to slide 10.

Dan Carlin: We believe <unk> has the potential to address large unmet needs in major brain health disorders based on the compelling results, we shared from our phase II trial for <unk> 120 <unk>.

Speaker Change: In this trial, we observed a rapid onset of effect with a one eight point reduction in clinical global impressions severity or CGI S. Within 24 hours and participants treated with 100 micrograms, which was highly statistically significant with a P value less than 0.000.

Daniel Karlin: The response was durable, showing a 21.9 point improvement on the Hamilton Anxiety Scale, or HAM-A, at week 12 in participants treated with 100 micrograms. This further improvement from week four indicates potential long-lasting effects. Importantly, the magnitude of response in participants given MM 120 was such that 48% of participants who received MM from 100 remained in remission at week 12. This high remission rate is particularly encouraging for a chronic condition like GH.

Daniel Karlin: The response was durable, showing a 21.9 point improvement in the Hamilton Anxiety Scale, or HAM-A, at week 12 in participants treated with 100 micrograms. This further improvement from week four indicates potential long-lasting effects. Importantly, the magnitude of response in participants given MM 120 was such that 48% of participants who received from 100 micrometers remained in remission at week 12. This high remission rate is particularly encouraging for a chronic condition like GAD.

Speaker Change: The response was durable showing a 21 nine point improvement in the Hamilton anxiety scale or handmade at week 12, and participants treated with 100 micrograms.

Speaker Change: Further improvement from week four indicates potential long lasting effects.

Speaker Change: Importantly, the magnitude of response and participants given <unk> 120, with such a 48% of participants who received from 100 micrograms remained in remission at week 12.

Speaker Change: This high remission rate is particularly encouraging for a chronic condition like J D.

Daniel Karlin: The treatment also demonstrated a favorable safety and tolerability profile, with most adverse events limited to the dosing day, which is crucial for patient acceptance and adherence. Finally, these results were achieved with no additional therapy, highlighting the potential for MM120 as a standalone treatment for GAD. These outcomes support our Phase 3 program. I'll now discuss our Phase 3 development plan for MM120 and GAD on slide 11. As Rob mentioned, in June, we completed a highly collaborative and constructive end-of-phase two meeting with FDA, reaching alignment on our phase three pivotal trial. This program will consist of two pivotal clinical trials, the VOYAGE study and the Panorama study. Each trial consists of two.

Speaker Change: Treatment also demonstrated a favorable safety and tolerability profile with most adverse events or eliminate the dose on day, which is crucial for patient acceptance and adherence.

Speaker Change: Finally, these results were achieved with no additional therapy, highlighting the potential for <unk> 120, as a standalone treatment for J D.

Speaker Change: Outcomes support our phase III program in <unk>.

I will now discuss our phase III development plan for <unk> 120, <unk> on slide 11.

Daniel Karlin: As Rob mentioned, in June, we completed a highly collaborative and constructive end-of-phase two meeting with FDA, reaching alignment on our phase three pivotal trial. This program will consist of two pivotal clinical trials, the VOYAGE study and the Panorama study. Each trial consists of two parts; Part A will be a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120-ODT versus placebo. Part B of each trial will be an open-label, 40-week extension study designed to provide important long-term data on the durability and potential retreatment profile of MM120.

Speaker Change: As Rob mentioned in June we completed a heightened collaborative and constructive end of phase two meeting with FDA, reaching alignment on our phase III pivotal trials.

Daniel Karlin: Voyage is anticipated to enroll approximately 200 participants who will be randomized one-to-one to receive MM120 ODT 100 micrograms or placebo. Panorama is anticipated to enroll approximately 240 participants who will be randomized five to two to five to receive MM120ODT 100 micrograms, MM120ODG50 micrograms, or placebo.

Daniel Karlin: Part A will be a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120-ODT versus placebo. Part B of each trial will be an open-label, 40-week extension study designed to provide important long-term data on the durability and potential retreatment profile for MM120. Voyage is anticipated to enroll approximately 200 patients, who will be randomized one-to-one to receive MM120-ODT 100 micrograms or placebo. Panorama is anticipated to enroll approximately 240 patients, who will be randomized five to two to five to receive MM120-ODT 100 micrograms. MM120ODG50 micrograms or placebo.

Speaker Change: This program will consist of two pivotal clinical trials the voyage study and the Panorama study.

Speaker Change: Each trial consists of two parts.

Speaker Change: Part a will be a 12 week randomized double blind placebo controlled parallel group study assessing the efficacy and safety of <unk> 120, ODT versus placebo.

Speaker Change: Part D of each trial will be an open label 40 week extension study designed to provide important long term data on the durability and potential re treatment profile for <unk> 120.

Speaker Change: Voyage is anticipated to enroll approximately 200 participants who will be randomized one to one to receive <unk> 120, <unk> 100 micrograms or placebo.

Speaker Change: Panorama is anticipated to enroll approximately 240 participants who will be randomized five two to five to receive <unk> 120, <unk> ODT 100, micrograms, and then 120, <unk> 50 micrograms or placebo.

Daniel Karlin: In accordance with FDA guidance and our regulatory discussions to date, our clinical program for MM120 continues to utilize complementary study designs across our Phase II and III studies to address key methodological issues such as functional unblindness. In this regard, in the panorama study, we are including a 50-microgram arm to confound participants' ability to accurately assess the dose condition to which they have been randomized. We believe that this approach builds on the evidence from our Phase IIb study in which we demonstrated that despite functional unblinding of all tested doses of MM120, the lower doses, 25 and 50 micrograms, did not demonstrate a meaningful clinical response, supporting our view that the amblytic response to MM120 is independent of functional unblinding.

Daniel Karlin: In accordance with FDA guidance and our regulatory discussions to date, our clinical program for MM120 continues to utilize complementary study designs across our Phase II and III studies to address key methodological issues such as functional unblindness. In this regard, in the panorama study, we are including a 50-microgram arm to confound participants' ability to accurately assess the dose condition to which they have been randomized. We believe that this approach builds on the evidence from our Phase 2B study in which we demonstrated that despite functional unblinding at all tested doses of MM120, the lower doses, 25 and 50 micrograms, did not demonstrate a meaningful clinical response, supporting our view that the anxiolytic response to MM120 is independent of functional unblinding.

Speaker Change: In accordance with FDA guidance, and our regulatory discussions to date, our clinical program and then 120 continues to utilize complementary study designs across our phase two three studies to address key methodological issues, such as functional and Brian.

Speaker Change: In this regard and the Panorama study, we are including the 50 microgram arm to confound participants ability to accurately assess the dose condition to which they have been randomized.

Speaker Change: We believe that this approach builds on the evidence from our phase <unk> study in which we demonstrated that despite functional and blinding all tested doses of min 120 to lower doses, 25% and 50 micrograms did not demonstrate a meaningful clinical response supporting our view that the antiemetic response to <unk>.

Speaker Change: <unk> is independent of functional and blinding.

Daniel Karlin: While we previously observed an almost 8-point improvement for MN120 over placebo at week 12, both Voyage and Panorama have been designed to have 90% power to detect a 5-point improvement over placebo based on certain statistical assumptions. Additionally, in both studies, we will use an adaptive design with an interim blinded sample size re-estimation, which allows for an increase in sample size of up to 50% in each study. This approach allows us to adjust for variability and nuisance parameters with the goal of maintaining statistical power and enhancing the interpretability of our results.

Daniel Karlin: While we previously observed an almost 8-point improvement for MN120 over placebo at week 12, both Voyage and Panorama have been designed to have 90% power to detect a 5-point improvement over placebo based on certain statistical assumptions. Additionally, in both studies, we will use an adaptive design with an interim blinded sample size re-estimation, which allows for an increase in sample size up to 50% in each study. This approach allows us to adjust for variability and nuisance parameters with the goal of maintaining statistical power and enhancing the interpretability of our results.

Speaker Change: While we previously observed in almost eight point improvement for <unk> over placebo at week 12, both voyage and Panorama had been designed to have 90% power to detect a five point improvement over placebo based on certain statistical assumptions. Additionally in both studies.

Speaker Change: We will use an adaptive design with an interim blinded sample size re estimation, which allows for an increase in sample size of up to 50% in each study.

Speaker Change: This approach allows us to adjust for variability in nuisance parameters with the goal of maintaining statistical power and enhancing interpreter ability of our results.

Daniel Karlin: Key elements such as inclusion and exclusion criteria will largely mirror our successful Phase 2b trial in GAD, and both Phase 3 studies will recruit adults aged 18-74 with a diagnosis of GAD and a HAM-A score of 20 or greater. During Part B of the Phase III studies, investigators will closely monitor patients using electronic patient-reported outcomes, central radar-assessed HAMAs, and clinician-administered scales. Participants will be eligible for re-treatment with MM120ODT 100 micrograms if their HAM-A score reaches 16 or higher, with up to four treatments available through Part B.

Daniel Karlin: Key elements such as inclusion and exclusion criteria will largely mirror our successful Phase 2b trial in GAD, and both Phase 3 studies will recruit adults aged 18-74 with a diagnosis of GAD and a HAMA score of 20 or greater. During Part B of the Phase III studies, investigators will closely monitor patients using electronic patient-reported outcomes, central radar-assessed HAMAs, and clinician-administered scales. Participants will be eligible for re-treatment with MM120ODT 100 micrograms if their HAM-A score reaches 16 or higher, with up to four treatments available through Part B.

Speaker Change: Elements, such as inclusion exclusion criteria will largely mirror, our successful phase <unk> trial in <unk>.

Speaker Change: And both phase III studies will recruit adults, aged 18 to 70 poor with a diagnosis of <unk> and our Ham score 20 or greater.

Speaker Change: During part B of the Phase III studies investigators will closely monitor patients using electronic patient reported outcomes central greater access to <unk> and clinician administered scales.

Speaker Change: <unk> will be eligible for re treatment with mm 120, ODT 100, micrograms, if theyre ma's core reaches 16 or higher with up to four treatments available through part D.

Daniel Karlin: Importantly, the design allows an assessment of the durability of the treatment effect, the need for and response to retreatment, and long-term safety. Key outcomes from Part B would include time to re-treatment or an, and we will also assess safety data on repeated treatments, average treatments per year, and response to retreatment. This information will be valuable in understanding the longer-term dynamics of MN120ODT treatment in GAD patients. Overall, both Voyage and Panorama are designed to be consistent with our successful Phase 2b trial, including using the HAM-A as our primary outcome measure, with the primary endpoint for the Phase 3 programs being changed from baseline to Week 12, which is consistent with the durability we observed in Phase 2.

Speaker Change: Importantly, the design allows an assessment of the durability of the treatment effect the need for and response to re treatments and long term safety.

Key outcomes from part B would include time to re treatment or in efficacy.

Speaker Change: We will also assess safety data on repeated treatments average treatments per year and response to retreat.

This information will be valuable and understanding of longer term dynamics of them with 120 ODT treatment in <unk> patients.

Daniel Karlin: Overall, both Voyage and Panorama are designed to be consistent with our successful Phase 2b trial, including using the HAM-A as our primary outcome measure, with the primary endpoint for the Phase 3 programs being changed from baseline to Week 12, which is consistent with the durability we observed in Phase 2. Based on the data we collected in Phase 2, we have also agreed with FDA to a reduction in treatment session duration from a minimum of 12 hours to 8 hours. This is operationally advantageous in our research program and enhances MM120's practicality in real world settings.

Speaker Change: Overall, both voyage and Panorama are designed to be consistent with our successful phase II b trial, including using the handmade as our primary outcome measure with the primary endpoint for the phase III programs being changed from baseline to week 12.

Speaker Change: Which is consistent with the durability, we observed in phase two.

Daniel Karlin: Based on the data we collected in Phase 2, we have also agreed with FDA to a reduction in treatment session duration from a minimum of 12 hours to 8 hours. This is operationally advantageous in our research program and enhances MM120's practicality in real-world settings. We will continue to collect data on monitoring times and safe parameters for determining the appropriate timing for ending sessions using structured, intentionally designed criteria to determine the time course and resolution of drug effects that could require monitoring. We are happy to say that we remain on track and expect to initiate our first phase three trial voyage in GAD this year.

Speaker Change: Based on the data we collected in phase II. We have also agreed with FDA to a reduction in treatment session duration from a minimum of 12 hours to eight hours.

Speaker Change: This is operationally advantageous in our research program and enhances <unk> practicality in real World settings, We will continue to collect data on monitoring times and safe parameters for determining the appropriate timing for ending sessions using structured intentionally designed criteria to determine that.

Daniel Karlin: We will continue to collect data on monitoring times and safe parameters for determining the appropriate timing for ending sessions using structured, intentionally designed criteria to determine the time course and resolution of drug effects that could require monitoring. We are happy to say that we remain on track and expect to initiate our first phase three trial voyage in GAD this. Turning to slide 12, as Rob stated earlier, we are also excited to announce the expansion of our R&D program for MM120 into MDD.

Speaker Change: <unk> and resolution of drug effects that could require monitoring.

Speaker Change: We're happy to say that we remain on track and expect to initiate our first phase III trial.

Speaker Change: In this.

Speaker Change: Next year.

Daniel Karlin: Turning to slide 12, as Rob stated earlier, we are also excited to announce the expansion of our R&D program for MM120 into MDD. Data from our Phase 2 GAD study led to our decision to pursue MDD as an additional indication for MM120, given the demonstrated potential for antidepressant effects. In the 100-microgram dose group, we observed an 18.7-point improvement from baseline in the Montgomery-Asperg Depression Rating Scale, or MADRAS, score at Week 12. This represented a 6.4-point advantage over placebo, which was statistically significant with a p-value less than 0.01.

Speaker Change: Turning to slide 12, as Rob stated earlier, we are also excited to announce the expansion of our R&D program for <unk> 120 into MDT Dave.

Daniel Karlin: Data from our Phase 2 GAD study led to our decision to pursue MDD as an additional indication for MM120, given the demonstrated potential for antidepressant effects. In the 100-microgram dose group, we observed an 18.7-point improvement from baseline in the Montgomery-Asperg Depression Rating Scale, or MADRAS, score at Week 12. This represented a 6.4-point advantage over placebo, which was statistically significant with a p-value less than 0.01.

Speaker Change: Data from our phase III <unk> study.

Speaker Change: Led to our decision to pursue MTBE as an additional indication for <unk> and 'twenty given the demonstrated potential for antidepressant effects.

Speaker Change: And the 100 microgram dose group, we observed an $18 seven point improvement from baseline in the Montgomery Asper depression rating scale or mattress score at week 12. This represented a six four point advantage over placebo, which was statistically significant with a P value less than 0.01.

Daniel Karlin: These results are particularly encouraging, given that the study wasn't powered for this endpoint and that baseline Madler scores were lower than we would expect in patients experiencing a major depressive episode, which appeared to create a ceiling effect on the response to MM120. Slide 13 represents the Phase 3 development program for MM120 and MDD, which we expect will consist of two pivotal clinical trials. Our first trial, the eMERGE study, like our pivotal trials in GAD, will be comprised of two parts.

Reid Robison: These results are particularly encouraging, given that the study wasn't powered for this endpoint and that baseline Madler scores were lower than we would expect in patients experiencing a major depressive episode, which appeared to create a ceiling effect on the response to MM120. Slide 13 represents the Phase 3 development program for MM120 and MDD, which we expect will consist of two pivotal clinical trials. Our first trial, the eMERGE study, like our pivotal trials in GAD, will be comprised of two parts.

Speaker Change: These results are particularly encouraging given the study wasn't powered for this endpoint and that baseline metrics scores were lower than we would expect in patients experiencing a major depressive episode, which appeared to create a ceiling effect on the response to enter more in 'twenty.

Speaker Change: Slide 13 represents the phase III development program for <unk>, 120, NMD, which we expect will consist of two pivotal clinical trials. Our first trial. The emerge study like our pivotal trials in <unk> will be comprised of two parts part a which is a 12 week.

Daniel Karlin: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of a single dose of MM120 ODD versus placebo, and Part B, which is a 40-week extension study during which participants will be eligible for open-label treatment with MM120-ODT subject to certain conditions for retreatment eligibility.

Reid Robison: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of a single dose of MM120 ODD versus placebo, and Part B, which is a 40-week extension study during which participants will be eligible for open-label treatment with MM120-ODT subject to certain conditions for retreatment eligibility. Emerge is anticipated to enroll at least 140 participants The primary endpoint in Emerge will be the change from baseline in MATRA score at week six between MM120ODT 100 micrograms and placebo.

Speaker Change: The randomized double blind placebo controlled parallel group study assessing the efficacy and safety of a single dose of <unk> 120, <unk> versus placebo.

Speaker Change: And part B, which is a 40 week extension study during which participants will be eligible for open label treatment with <unk> 120, ODT subject to certain conditions for re treatment eligibility.

Daniel Karlin: Emerge is anticipated to enroll at least 140 participants randomized one-to-one to receive MM120ODT 100 micrograms or placebo. The primary endpoint in Emerge will be the change from baseline in MATRA score at week six between MM120ODT 100 micrograms and placebo. We expect to conduct a second registrational trial in MDD in the future, with the design and timing to be informed by the eMERGE study and additional regulatory discussions. As Rob mentioned earlier, our planned execution of the MM 120 program and MDD will balance this exciting opportunity across two pivotal programs with our continued operational and financial diligence. With that, I am happy to introduce Dr. Reid Robison, who will provide his perspective on our phase three trial. Thanks, Dan.

Speaker Change: Emerge is anticipated to enroll at least 140 participants randomized one to one to receive <unk> 102000, ODP 100 micrograms or placebo.

Speaker Change: Primary endpoint in emerge will be the change from baseline in mattress score at week six between <unk> 120, ODT 100, micrograms and placebo.

Reid Robison: We expect to conduct a second registrational trial in MDD in the future, with the design and timing to be informed by the eMERGE study and additional regulatory discussions. As Rob mentioned earlier, our planned execution of the MM120 program and MDD will balance this exciting opportunity across two pivotal programs with our continued operational and financial diligence. With that said, I am happy to introduce Dr. Reid Robison, who will provide his perspective on our phase three trial.

Speaker Change: We expect to conduct a second registrational trial in <unk> in the future with the design and timing to be informed by the emerge study and additional regulatory discussions.

Unknown Executive: Music Good morning and welcome to the MindMedicine Second Quarter 24 Financial Results and Corporate Updates Conference call. Currently all participants are in the listening mode. This call is being broadcast live on the investor's immediate section of MindMed's website at MindMed.co and a recording will be available after the call.

As Rob mentioned earlier, our planned execution of the <unk> 120 program and MDT, we're balanced this exciting opportunity across two pivotal programs with our continued operational and financial diligence.

Reed Robinson: With that I am happy to introduce Dr. Reed Robinson, who will provide his perspective on our phase III trials.

Reid Robison: I'm very excited about the Phase 3 development programs that you just shared, as I believe they stand to make a significant impact in the field of psychiatry. I've been personally thrilled with the results I've seen so far from MindMed's MM120 development program. The GAD Phase 2B results are truly impressive, with MM120 exhibiting rapid and robust efficacy, sustained 12 weeks after a single dose. Equally impressive is the change in MADRA score from baseline to Week 12 in the Phase 2B GAD trial participants, showing improvement in comorbid depressive symptoms. For people suffering from GAD, including with comorbid depression, these trials offer a beacon of hope. And I've seen firsthand how debilitating both conditions are, severely impacting quality of life.

Reid Robison: Dan, I'm very excited about the Phase 3 development programs that you just shared, as I believe they stand to make a significant impact in the field of psychiatry. I've been personally thrilled with the results I've seen so far from MindMed's MM120 development program. The GAB Phase 2B results are truly impressive, with MM120 exhibiting rapid and robust efficacy sustained 12 weeks after a single dose. Also impressive is the change in Madras score from baseline to week 12 in the Phase 2B GAD trial participants, showing improvement in comorbid depressive symptoms. For people suffering from GAD, including with comorbid depression, these trials offer a beacon of hope. And I've seen firsthand how debilitating both conditions are, severely impacting quality of life.

Reed Robinson: Thanks, Dan.

Reed Robinson: I am very excited about the phase III development programs that you just shared.

Reed Robinson: As I believe they stand to make a significant impact in the field of psychiatry I've been personally thrilled with the results I've seen so far from my Meds <unk> 'twenty development program. The phase III <unk> results are truly impressive with <unk> 120, exhibiting rapid and robust efficacy sustained 12 weeks after a.

Robert Barrow: I would now like to introduce Rob Barrow, CEO of MindMed, please go ahead. Thank you. Good morning, everyone. Welcome to our second quarter, 2024 Financial Results and Corporate Updates Conference call. Today, we will be sharing highlights from the second quarter, along with the significant progress we've made with plans for our phase three program in generalizing value disorder or GAD. Additionally, I'm excited to share further specifics about the expansion of our R&D program for MN120 into major depressive disorder or MDD, both of which are further supported by the financing we announced last week.

Reed Robinson: Single dose equally impressive is the change in Madras score from baseline to week 12 in the phase <unk> trial participants showing improvement in comorbid depressive symptoms.

Reed Robinson: For people suffering from <unk>, including with Comorbid Depression. These trials offer a beacon of hope.

Robert Barrow: The press release reporting our financial results and the presentation we will be using on today's call are both available in the investors and media section of our website and our quarterly report on form 10Q to the quarter ended June 30th, 2024, was filed this morning with the Securities and Exchange Commission. During today's call and outline on slide two, we will be making certain forward looking statements, including without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidates, our anticipated cash runway, and our future expectations, plans, partnerships and prospects.

Reed Robinson: And I've seen firsthand, how debilitating both conditions are severely impacting quality of life give.

Reid Robison: Given that current standards of care are falling short of meeting our patients' needs, it is vital that we develop and bring to market new, effective treatment options. Three things stand out about phase three development programs that are important from an investigator and physician perspective that I want to share with you today. First, the phase three programs are operationally efficient. Second, they enhance our ability to recruit patients. And third, the phase two and three trials are similar in design, suggesting a high degree of read through as possible. All of this will make our execution of these trials more seamless. I'll break all three attributes down further.

Speaker Change: Given that current standards of care falling short of meeting their patients' needs. It is vital that we develop and bring to market new effective treatment options.

Reid Robison: Second, they enhance our ability to recruit patients. And third, the phase two and three trials are similar in design, suggesting a high degree of read through as possible. All of this will make our execution of these trials more seamless. I'll break all three attributes down further.

Speaker Change: Three things stand out about the phase III development programs that are important from an investigator and physician perspective that I want to share with you today.

Reid Robison: From an operational perspective, the key design elements of both phase 3 programs make them efficient to run. This operational ease is crucial as it allows my team to manage the trials effectively while maintaining scientific rigor. In the GAD trials, reducing treatment session monitoring from 12 to 8 hours is an example of this, making delivery of MM120 more practically feasible, mirroring how I would expect to treat patients if MM120 is approved. Another significant advantage of these trials is our ability to efficiently recruit and enroll patients. While the GAD program will start earlier than the MDD program, having both programs run concurrently, we can tailor recruitment efforts to match specific diagnoses.

Speaker Change: First the phase III programs are operationally efficient second they enhance our ability to recruit patients and third the phase two and three trials are similar in design, suggesting the high degree of read through as possible. All of this will make our execution of these trials more seamless I'll break all three attributes.

Robert Barrow: These statements are subject to various risks such as changes in market condition and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC, including our annual report on form 10K and our form 10Q file today. For looking statements are based on the assumption, opinions and estimates of management of the date statements are made, including the non occurrence of the risks and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of my meds and our course of business.

Speaker Change: Down further.

Speaker Change: From an operational perspective, the key design elements of both phase III programs make them efficient to run this operational ease is crucial as it allows my team to manage the trials effectively while maintaining scientific rigor.

Speaker Change: And the JD trials, reducing treatment session monitoring from 12 to eight hours as an example of this making delivery of <unk> 120, more practically feasible mirroring how I would expect to treat patients. If 120 is approved.

Robert Barrow: Your caution not to replace undue reliant from these forward looking statements, which are made as of today, August 13, 2024. My meds explains any obligation to update such statements, even if management views change, except is required by law. Let me begin by taking you through today's agenda on slide three. I'll start with our Q2 2024 business update, and then Dr. Dan Carlin, our chief medical officer, will join to discuss our R&D plans for M1-20 World Cinegrating Tablet or ODD in GAD and MGD.

Speaker Change: Another significant advantage of these trials is our ability to efficiently recruit and enroll patients while the JV program will start earlier than the MDT program, having both programs run concurrently we can tailor recruitment efforts to match specific diagnoses.

Reid Robison: GAD and MDD have overlapping symptoms, and this approach improves our ability to put patients in whichever program is appropriate for their clinical presentation, thereby accelerating enrollment. Lastly, the design of these trials directly builds on MindMed's Phase 2B GAD trial results. This continuity enables us to build on existing data, enhancing the ability to validate prior findings and the efficacy and safety of MM120-ODT with a high degree of consistency. In addition, the 12-week primary endpoint for the Phase 3 trials in GAD should provide evidence of durability, which I believe is of utmost importance to physicians and patients.

Speaker Change: And MTBE have overlapping symptoms and this approach improves our ability to put patients in whichever program as appropriate for their clinical presentation, thereby accelerating enrollment.

Speaker Change: Lastly, the design of these trials directly builds our mind meds phase two b trial results.

Unknown Executive: We are also pleased to be joined by Dr. Reid Robison, Senior Principal Investigator, Cedar Clinical Research, and Adjunct Faculty at the University of Utah.

Speaker Change: This continuity enables us to build on existing data enhancing the ability to validate prior findings and the efficacy and safety of <unk> 120, ODT with a high degree of consistency. In addition, the 12 week primary endpoint for the phase III trials in JD should provide evidence on durability, which I.

Unknown Executive: Dr. Robison is an investigator in our MN120 clinical development program and provides his views on our phase three clinical trials. Following Dr. Robison, I'll discuss our second quarter financial highlights.

Robert Barrow: Gera anticipated upcoming milestones and then we'll conclude with a Q&A session where we will also be joined by Dr. Francois Robison, our Chief Commercial Officer, to answer your questions. On slide four, I'm pleased to share our progress with the quarter and to the first half of the year. In June, we successfully completed a constructive end-of-phase two meeting, the US Student Drug Administration, which supports the advancement of MN120 and a pivotal phase three clinical trials for GAD.

Speaker Change: Believe is of utmost importance to physicians and patients.

Reid Robison: I'm looking forward to getting these Phase III trials started. They have the potential to pave the way for significant advancements in treating GAD and MDD, and I'm eager to see the results so MindMed can move forward with the development of MM120 and make a meaningful impact on patients' lives.

Reid Robison: I'm looking forward to getting these phase three trials started. They have the potential to pave the way for significant advancements in treating GAD and MDD, and I'm eager to see the results. Then, MindMed can move forward with the development of MM120 and make a meaningful impact on patients' lives. And with that, I'll turn the call back over to Rob.

Speaker Change: Im looking forward to getting these phase III trials started they have the potential to pave the way for significant advancements in treating <unk> and MDT and I'm eager to see the results from mine Med can move forward with the development of am 120, and make a meaningful impact on patients' lives and with that I'll turn the call back.

Robert Barrow: Thank you, Dr. Robison. We're excited to get started and grateful to be aligned on our pivotal programs with clinicians like you. I'll now turn to our financial results for the quarter ended June 30th, 2024, which are highlighted on slide 15. As of June 30, 2024, the company had cash and cash equipment totaling $243.1 million, compared to $99.7 million as of December 31, 2023. We believe that our cash and cash equivalents, as of June 30, 2024, combined with the proceeds from our recently closed financing, will be sufficient to fund our operations into 2027.

Rob: Over to Rob.

Robert Barrow: We are on track to initiate our first phase three trial for MN120 ODK in GAD in the second half of 2024, which marks the same major milestone in our development program. We are also excited to share with you our plans to expand our R&D program for MN120 into MDD with the initiation of the emergency study, a registration clinical trial for MN120 ODK and MDD, which we expect to be initiated in the first half of 2025.

Rob: Thank you Dr Robinson.

Speaker Change: Excited to get started are grateful to be align of our pivotal programs with clinicians like here.

Robert Barrow: Based on our current operating plan and anticipated R&D milestones, we expect this cache runway to extend at least 12 months beyond the top-line data readout for our first phase 3 trial of MN120 in GAD. For the six months ended June 30, 2024, net cash used in operating activities was $36.6 million, compared to $27.2 million for the same period in 2023.

Robert Barrow: We believe that our cash and cash equivalents, as of June 30th, 2024, combined with the proceeds from our recently closed financing, will be sufficient to fund our operations into 2027. Based on our current operating plan and anticipated R&D milestones. We expect this cache runway to extend at least 12 months beyond the top line data readout for our first phase 3 trial of MN120 in GAD. For the six months ended June 30, 2024, net cash used in operating activities was $36.6 million, compared to $27.2 million for the same period in 2023.

Speaker Change: I'll now turn to our financial results for the quarter ended June 32024, which are highlighted on slide 15.

Robert Barrow: Research and development expenses were $14.7 million for the quarter ended June 30, 2024, compared to $14.8 million for the same period in 2023, representing a decrease of $0.1 million. The decrease is primarily due to decreases of $0.5 million in expenses related to our MM120 GAD program and a decrease of $2 million in expenses related to preclinical activities, partially offset by an increase of $1 million in internal personnel costs as a result of increasing research and development capacity and an increase of $1.4 million in expenses related to our MN402 program.

Speaker Change: As of June 32024, the company had cash and cash equivalents totaling $243 1 million.

Speaker Change: Compared to $99 7 million as of December 31, 2023.

Speaker Change: We believe that our cash and cash equivalents as of June 32024, combined with the proceeds from our recently closed financing will be sufficient to fund our operations into 2020.

Robert Barrow: We also expect to conduct a second registration study in MDD with a study design and timing to be informed by the Emerge Study and additional regulatory discussion. The scope and sequencing of our clinical program for MN120 and MDD is being carefully executed to balance the exciting opportunity represented by MDD on maintaining a cash runway into 2027. With this approach, we believe our cash runway will be sufficient to support operations for at least 12 months beyond our first phase three readout in GAD.

Speaker Change: Based on our current operating plan and anticipated R&D milestones. We expect this cash runway to extend at least 12 months beyond the top line data readout for our first phase III trial, and then 120 <unk>.

Speaker Change: For the six months ended June 32024, net cash used in operating activities was $36 $6 million.

Robert Barrow: In June, we announced the US Patent and Trademark Office issued a new patent covering the formulation and manufacturing methods MN120 ODK that extends our intellectual property protection for MN120 ODK through 2041, providing further runway for potential commercialization. We have also seen continued progress with our second read program MN402, which is our proprietary form of the R&D of NDMA. We are currently evaluating MN402 in a phase one, single-estimating dose trial and healthy adults intended to characterize tolerability, pharmacokinetics, and pharmacodynamics.

Speaker Change: Compared to $27 2 million for the same period in 2023.

Speaker Change: Research and development expenses were $14 7 million for the quarter ended June 32024, compared to $14 8 million for the same period in 2023, representing a decrease of zero point $1 million.

Speaker Change: The decrease was primarily due to decreases of <unk> 5 million in expenses related to our it and then 120 <unk> program.

Speaker Change: The decrease of $2 million of expenses related to preclinical activities.

Partially offset by an increase of $1 million and internal personnel costs.

Speaker Change: As a result of increasing research and development capacity.

Robert Barrow: We expect the results from this trial will enable further clinical trials to characterize the effects of repeated daily doses MN402 in the exploration of early signs of efficacy in the autism spectrum disorder population. Lastly, I'm pleased to report that we just completed a successful underwritten public offering, raising approximately $75 million in gross proceeds before deducting transaction fees and other offering related expenses. Based on our current operating plans, we believe that the proceeds from this offering, in addition to our cash and cash equivalence as of June 30th, 2024, extends our cash runway into 2027, and at least 12 months beyond our first phase three clinical readout in G.A.

Speaker Change: An increase of $1 4 million expenses related to our <unk> program.

Robert Barrow: We do anticipate R&D expenses to ramp up in the second half of this year and in 2025 as we get the Phase III studies in GAD and MDD up and running. General and administrative expenses were $9.8 million for the quarter ended June 30, 2024, compared to $14.4 million for the same period in 2020. A decrease of $4.6 million. The decrease was primarily attributable to professional services fees and expenses during the three months ending June 30, 2023.

Speaker Change: We do anticipate R&D expenses to ramp up in the second half of this year and in 2025 as we get the phase III study JD and MDT up and running.

Speaker Change: General and administrative expenses were $9 8 million for the quarter ended June 32024, compared to $14 4 million for the same period in 2023, a decrease of $4 $6 million.

Robert Barrow: A Decrease of $4.6 Million. The decrease was primarily attributable to professional services fees and expenses during the three months into June 30, 2023, related to the proxy contest in connection with our 2023 Annual General Meeting of Shareholders, partially offset by increased stock-based compensation. The company's net loss for the quarter ended June 30, 2024 was $5.9 million, compared to $29.1 million for the same period in 2023. The decrease was primarily due to changes in the fair value of 2022 U.S. dollar financing warrants of $15 million.

Speaker Change: The decrease was primarily attributable to professional services fees and expenses during the three months ended June 32023.

Robert Barrow: Regarding the proxy contest in connection with our 2023 Annual General Meeting of Shareholders, partially offset by increased stock-based compensation. The company's net loss for the quarter ended June 30, 2024 was $5.9 million, compared to $29.1 million for the same period in 2023. The decrease was primarily due to changes in the fair value of 2022 U.S. dollar financing warrants of $15 million.

Speaker Change: Relating to the proxy contest in connection with our 2023 annual general meeting of shareholders, partially offset by increased stock based compensation expense.

Robert Barrow: D&D. Importantly, this funding demonstrates the continued enthusiasm towards our programs and strategy and allows us to rapidly advance MN120 in both GAD and MDD. Here on Slide 5 is a look at our pipeline of three critical stage programs, including our Phase 3 trials for MN120 and GAD and MDD. As I mentioned, we remain on track to initiate the pivotal Phase 3 program for MN120 and GAD in the second half of 2024, and we intend to initiate the first registration study in our newly announced MDD program in the first half of 2025.

Speaker Change: The company's net loss for the quarter ended June 32024 was $5 9 million.

Speaker Change: Compared to $29 1 million for the same period in 2023.

Speaker Change: The decrease was primarily due to changes in the fair value of 2020, Q U S dollar finance warrants a $15 million.

Robert Barrow: This is an exciting time for us at MindMed with many key catalysts coming up over the next couple of years, as you can see highlighted on slide 16. We anticipate initiating Voyage, our first phase 3 trial in GAD, in the second half of 2024, and Panorama, our second phase 3 trial in GAD, in the first half of 2025. We also expect to initiate eMERGE, our first phase three clinical trial in MDD, in the first half of 2025.

Robert Barrow: This is an exciting time for us at MindMed with many key catalysts coming up over the next couple of years, as you can see highlighted on slide 16. We anticipate initiating Voyage, our first Phase 3 trial in GAD, in the second half of 2024, and Panorama, our second Phase 3 trial in GAD, in the first half of 2025. We also expect to initiate eMERGE, our first phase three clinical trial in MDD, in the first half of 2025. We're projecting top line Part A readouts for these pivotal trials, starting with Voyage in the first half of 2026, and then Panorama and Emerge in the second half of 2026.

Speaker Change: This is an exciting time for us at mine led with many key catalysts coming up over the next couple of years.

Speaker Change: As you can see highlighted on slide 16.

Speaker Change: We anticipate initiating voyage, our first phase III trial in the second half of 2024 and Panorama, our second phase III trial in the first half of 2025.

Robert Barrow: As detailed on Slide 6, MN120 has shown significant potential in addressing large unmet needs and brain health disorders. Our Phase 2D trial for MN120 and GAD didn't affect size more than double that of the standard of care, and a 48% remission rate 12 weeks after a single dose. We also observed significant rapid and durable effects on co-ordered depression symptoms in GAD patients. In the U.S, alone, there are 20 million adults with GAD and 31 million adults with MDD.

Speaker Change: We also expect to initiate emerged our first phase III clinical trial in MTBE in the first half of 2025.

Robert Barrow: We're projecting top-line Part A readouts for these pivotal trials, starting with Voyage in the first half of 2026, and then Panorama and Emerge in the second half of 2026. These anticipated milestones represent significant value inflection points for our company and could potentially bring us closer to providing novel and highly differentiated treatment options for patients with GAD and MDD. We believe that the evidence generated to date on MM120 validates our scientific understanding of MM120's mechanism of action and shows the potential for an emerging best-in-class product profile compared to today's standards of care.

Speaker Change: We're projecting topline part a readouts of these pivotal trials starting with voyage in the first half of 2026, and then panorama and emerge in the second half of 2026.

Robert Barrow: These anticipated milestones represent significant value inflection points for our company and could potentially bring us closer to providing novel and highly differentiated treatment options for patients with GAD and MDD. We believe that the evidence generated to date on MM120 validates our scientific understanding of MM120's mechanism of action and shows the potential for an emerging best-in-class product profile compared to today's standards of care. We are excited to advance our pipeline and to be on the cusp of moving forward with our pivotal development programs for MN120 in both GAD and MDD.

Speaker Change: Do you anticipated milestones represent significant value inflection points for our company and potentially bring us closer to providing novel and highly differentiated treatment options for patients with <unk> and MTGE.

Robert Barrow: Of these, 13 million and 18 million are treated annually for GAD and MDD respectively. These two markets represent a substantial opportunity for effective treatments. We believe that if approved, MN120 could also patient the differentiating compelling option in both GAD and MDD, which could position it to become the best in class treatment option, starting two of the biggest market opportunities in psychiatry. Slide 7 outlines our overall program for MN120 and GAD and MDD, which incorporates constructive feedback from our recently completed end-to-face convening with FDA.

Speaker Change: We believe the evidence generated to data.

Speaker Change: The mechanism of action.

Speaker Change: The potential for an emerging best in class product profile compared to today's standards of care.

Robert Barrow: We are excited to advance our pipeline and to be on the cusp of moving forward with our pivotal development programs for MN120 in both GAD and MDD. With strong market protection and IP strategies and a cash runway into 2027 and 12 months beyond our first phase three readout, we are well positioned to execute on our strategy. As we conclude, I want to extend my sincere appreciation and gratitude for the critical work and careful execution that has brought MindMed ever closer to realizing its mission.

Speaker Change: We are excited to advance our pipeline and to be on the cost of moving forward with our pivotal development programs, and then 120 and both ghd and MDT.

Robert Barrow: With strong market protection and IP strategies and a cash runway into 2027 and 12 months beyond our first phase three readout, we are well positioned to execute on our strategy. As we conclude, I want to extend my sincere appreciation and gratitude for the critical work and careful execution that has brought MindMed ever closer to realizing its mission. I'd 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, especially our patients and their families.

Speaker Change: With strong loss protection, and IP strategy, and a cash runway into 2027 and 12 months beyond our first phase III readout, we are well positioned to execute on our strategy.

Robert Barrow: In the coming quarters, we anticipate initiating three registrational studies across the GAD and MDD programs, including the voyage and panorama studies in GAD and the emerged study in MDD. The initiation of pivotal studies for MN120 truly represents a major milestone for MN120, as we strive to become a leader in developing novel treatments to address brain health disorders.

Speaker Change: As we conclude I won't take so much sincere appreciation and gratitude to the critical work and careful execution that was brought by med ever closer to realizing our mission.

Robert Barrow: I'd 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, especially our patients and their families. We are working tirelessly to deliver on the therapeutic potential of our pipeline and to transform the treatment landscape for the many individuals living with brain health disorders. With that, I'd like to thank you all again for joining us today. The team and I are happy to take any questions.

Speaker Change: I would like to thank our highly talented and deeply committed team our research collaborators and clinical investigator teams our investors.

Robert Barrow: Before turning to call over to Dan to go over the details and designs of our phase three studies, I wanted to take a minute to address our approach to some of the major topics that have come in focus since the FDA Pharmacologic Drug Advisory Committee, meeting earlier this year, an FDA's recent decision on Lycocerapidic's application from MDMA Assistant Therapy for PTSD. Our development strategy outlined on slide eight is rigorous and thoughtful and continues to be appreciated by regulators, researchers, clinicians, and research participants.

Speaker Change: Many other individuals who have been supported 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 the many individuals living with brain health disorders. With that, I'd like to thank you all again for joining us today. The team and I are happy to take any questions.

Speaker Change: We are working tirelessly to deliver on the therapeutic potential of our pipeline.

Speaker Change: <unk> for the treatment landscape through many individuals living with brain health disorders.

Speaker Change: With that I'd like to thank you all again for joining today and the team and I are happy to take any questions.

Operator: To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Charles Duncan with Cantor. Your line is now open.

Speaker Change: Thank you.

Speaker Change: To ask a question. Please press star one on your telephone and wafer your name to be announced to withdraw your question. Please press star one again please.

Robert Barrow: We believe this will ultimately translate into confidence for patients with prescribers. Specifically, we have implemented several strategies to address key methodological consideration in the drug class, including the use of central Raiders, blinded to both treatment assignment and visit number, the inclusion of expectancy and blinding questionnaires, and perhaps most importantly, the elimination of psychotherapy intervention in our clinical trials. Additionally, our approach to safety monitoring call is well-established industry best practice, practices in both of our phase three clinical trials and dedicated clinical pharmacology trials.

Speaker Change: Please stand by while we compile the Q&A roster.

Speaker Change: Our first question comes from the line of Charles Duncan with Cantor. Your line is now open.

Elaine Kim: Hi, this is Elaine Kim on behalf of Charles. Thank you for taking our questions. This is a two-part question. For the first question, is the open-label 100 microgram dose intended to help maintain response or remission rates? versus having patients continue the 50-microgram dose in the 40-week follow-up. And for my second question, if the reduction of the treatment session duration to eight hours from 12 hours was agreed by the FDA, and what requirements for patient care following the eight-hour treatment session will be implemented? Thank you. Yeah, thanks so much, Elaine.

Elaine Kim: Hi, this is Elaine Kim on for Charles. Thank you for taking our questions. This is a two parter.

Speaker Change: Hi, This is lane Kim on for Charles Thank you for taking our questions just as a true partner.

Elaine Kim: For the first question, is the open-label 100 microgram dose to help maintain response or remission rates versus having patients continue the 50-microgram dose at the 40-week follow-up? And for my second question, if the reduction of the treatment session duration to eight hours from 12 hours was agreed by the FDA, what information enabled this decision to be made, and what requirements were for patient care following the eight-hour treatment session? What requirements will be implemented? Thank you.

Speaker Change: First question is the open label 100, microgram dose to help maintain response and remission rates.

Speaker Change: First of all having patients continue the 15 microgram dose and the 40 week follow up.

Speaker Change: And then my second question.

Robert Barrow: We intend to fully and robustly characterize the safety of M120. Our development of M120 has been carefully designed with the highest clinical and ethical standards to align up with FDA guidance. We believe that our well-designed phase 2B trial for M120 and GAD demonstrated compelling tolerability and efficacy data, which exceeds today's standard of care. Additionally, we continue to publish scientific research back by the robustness of our clinical data and our increasing body of evidence for M120's potential as an emerging best-in-class product candidate, along with the growing unmet need to treat patients suffering from GAD, MDD, and other brain health disorders.

So a reduction of the treatment session duration to eight hours from 12 hours.

Speaker Change: What information enabled this decision to the inquiry by the SBA.

Speaker Change: Requirements for.

Speaker Change: Patient care following the eight hour treatment session.

Speaker Change: What requirements will be implemented thank you.

Unknown Executive: Yeah, thanks so much, Elaine. To the first question, so when we're designing the Phase 3 program, continuing patients on, I think two things are worth pointing out with the open-label part B portion of the study, or I should say the extension part B of the study. The first thing is that we've been really thoughtful about how we analyze and think about the extension phase of the study because until patients actually receive open-label treatment in part B of the study, they remain in a blinded status, is someone that actually received an open-label drug while it's an extension study with open-label opportunities for treatment. They haven't actually received anything, which is unusual here.

Lane Kim: Yes, thanks, so much lane.

Unknown Executive: To the first question, so when we're designing the Phase 3 program, Continuing Patients On, I think two things are worth pointing out with the open-label Part B portion of the study, or I should say the extension Part B of the study. First, we've been really thoughtful about how we analyze and think about the extension phase of the study because until patients actually receive open-label treatment in Part B of the study, they remain in a blinded status, is someone that actually received an open-label drug while it's an extension study with open-label opportunities for treatment. They haven't actually received anything yet, which is unusual here.

Speaker Change: So the first question so when we're designing the phase III program.

Speaker Change: Continuing patients are in I think two things are worth pointing out with the open label part B portion of the study or I should say the extension part b of the study.

Speaker Change: Is that.

Robert Barrow: As we embark on our pivotal development programs for M120, we remain both appreciative and excited by FDA's commitment to advancing research for the psychedelic drug class. This has been exemplified both through FDA's recent public statements, in which they indicated that they continue to encourage research and drug development that will further innovation for psychedelic treatment. In addition to the high degree of engagement and partnership that we have experienced and numerous interactions with the FDA over the course of the year.

Speaker Change: We've been really thoughtful about how we analyze and think about the extension phase of the study because until patients actually receive open label treatment and that part B of the study they remained in a blinded status.

Speaker Change: So some of them had actually received open drug.

Speaker Change: While it's an extension study with open label opportunities for treatment. They haven't actually received anything which is unusual here.

Unknown Executive: Certainly wouldn't be the case in that case, an open-label extension of a daily medicine. The selection of 100 micrograms is because it is the clinical dose of interest. Relying on our Phase 2B results, we believe 100 micrograms is our go-forward dose, and our modeling from the Phase 2B results and the MCP mod analysis we conducted there suggests that it is the dose to take forward and the efficacy dose we should be studying.

Unknown Executive: Certainly wouldn't be the case in the case of the Mobile Extension of a Daily Medicine. The selection of 100 micrograms is because it is the clinical dose of interest. Relying on our phase 2B results, we believe 100 micrograms is our go-forward dose, and our modeling from the phase 2B results and the MCP mod analysis we conducted there suggests that it is the dose to take forward and the efficacy dose we should be studying.

Speaker Change: Certainly wouldn't be the case in the case.

Speaker Change: The open label extension of a daily medicine.

Daniel Karlin: Now, I'd like to turn the call over to Dr. Dan Karlin, our Chief Medical Officer, to discuss our clinical development programs in detail. Dan, thank you, Rob. Turning to slide 10, we believe M120 has the potential to address large unmet needs in major brain health disorders, based on the compelling results we shared from our phase 2 trial for M120 and GAD. In this trial, we observed a rapid onset of effect with a 1.8-point reduction in clinical, global impressions severity, or CGIS, within 24 hours in participants' feed with 100 micrograms, which was highly statistically significant, with a p-value less than 0.001.

Speaker Change: The selection of a 100 micrograms is because it is the clinical dose of interest.

Speaker Change: Lying on our phase <unk> results, we believe.

Speaker Change: 100 microgram dose is our go forward dose in our modeling from the phase III results in the MCP Mod analysis. We conducted there suggests that it is the dose to take forward in the efficacious dose we should be studying.

Unknown Executive: Whereas the 50 microgram dose is there simply as a functional mask, an additional control to aid in addressing the concept of functional online. That's the rationale; we're not interested in 50 micrograms of a clinical dose to take forward or to be submitted. The intent is to characterize what happens in a more real-world-like setting where patients would have the opportunity for re-treatment upon the re-emergence or Continue The Next through the initial phase of the study. In terms of Part B, your question or the second part of the question.

Unknown Executive: Whereas the 50 microgram dose is there simply as a functional mask, an additional control to aid in addressing the concept of functional blindness. That's the rationale; we're not interested in 50 micrograms of a clinical dose to take forward or to be submitted. The intent is to characterize what happens in a more real world setting where patients would have the opportunity for retreatment upon the reemergence or Continue to Next through the initial phase of the study. In terms of Part B, your question, or the second part of your question.

Speaker Change: Whereas the 50 microgram dose is there simply as a.

Speaker Change: Functional mask as an additional control to aid in addressing the concept of a functional on blinding.

Speaker Change: That's the rationale.

Speaker Change: We're not interested in 50 microgram as a clinical dose a quarter or it could be submitted at this time.

As to characterize what happens.

Daniel Karlin: The response was durable, showing a 21.9-point improvement in the Hamilton anxiety scale, or HMA, at week 12 in participants' feed with 100 micrograms. This further improvement from week 4 indicates potential long-lasting effects. Importantly, the magnitude of response in participants given M120 was such that 48% of participants who received from 100 micrograms remained in remission at week 12. This high remission rate is particularly encouraging for a chronic condition like GAD. The treatment also demonstrated a verbal safety and tolerability profile, with most adverse events limited to the dosing day, which is crucial for patient acceptance and adherence. Finally, these results were achieved with no additional therapy, highlighting the potential for M120 as a standalone treatment for GAD. These outcomes support our phase 3 program in GAD.

Speaker Change: Our real world like setting where patients we have the opportunity for re treatment upon the Ria.

Speaker Change: Emergence or D continue.

Speaker Change: Continued in efficacy.

Speaker Change: After the initial phase of the study.

Speaker Change: Okay.

Speaker Change: In terms of part B of your question or second part of your question.

Unknown Executive: We presented data, so from very early on, and this has been a point of discussion since the advisory committee earlier this year, we have been very intentional about designing structured criteria for when patients would be allowed to end their monitoring. In phase two, we went to the extreme of conservatism and used the DSM-5 definition of hallucinogen intoxication. So patients had to be cleared by meeting effectively no signs of hallucinogen intoxication.

Unknown Executive: We presented data. So from very early on, and this has been a point of discussion since the advisory committee earlier this year, we have been very intentional about designing structured criteria for when patients would be allowed to end their monitoring session. In phase two, we went to the extreme of conservatism and used the DSM-5 definition of hallucinogen intoxication. So patients had to be cleared by meeting effectively no signs of hallucinogen intoxication.

Speaker Change: We presented data.

Speaker Change: From very early on and obviously, it's been a point of discussion 30 Advisory Committee earlier this year.

Speaker Change: We have been very intentional about designing structured criteria for when patients would be allowed to and they're monitoring session.

Speaker Change: In phase two we went to the extreme conservatism and use the DSM five definition of hallucinogen intoxication, so patients had to be cleared.

By meeting effectively no signs of hallucinogen intoxication.

Unknown Executive: As we've continued our regulatory discussions and our thinking has further evolved and been informed by the data, we have refined that checklist to be much more modeled around what we'd expect to be representative of a real world rims like checklist for releasing patients after a dosing session. So we presented data; we collected a time course of those assessments in our phase 2b study to characterize exactly the sort of temporal curve of which one patient would be able to be.

Unknown Executive: As we've continued our regulatory discussions and our thinking has further evolved and been informed by the data, we have refined that checklist to be much more modeled around what we'd expect to be representative of a real world RIMS-like checklist for releasing patients after a dosing session. So we presented data, and we collected a time course of those assessments in our phase 2b study to characterize exactly the sort of temporal curve of when patients would be able to be

As we've continued our regulatory discussions.

Speaker Change: Thinking has further evolved and been informed by the data we have.

Speaker Change: Refine that checklist to be much more model around what we would expect to be representative of a real world Rems like.

Daniel Karlin: I'll now discuss our phase 3 development plan for M120 in GAD on slide 11. As Rob mentioned, in June, we completed a highly collaborative and constructive end of phase 2 meeting with FDA, reaching alignment on our phase 3 pivotal trial. Piros. This program will consist of two pivotal clinical trials, the Voyage Study and the Panorama Study. Each trial will consist of two parts. Part A will be a 12-week randomized, double-blind, placebo-controlled, parallel-group study, assessing the efficacy and safety of MM120ODT versus placebo.

Speaker Change: Checklist for for releasing patients after dosing session. So we presented data.

Speaker Change: The time course of those.

Speaker Change: Assessments and our phase <unk> study to characterize exactly the sort of temporal curve of.

Speaker Change: When patients will be able to be.

Unknown Executive: Part of a Clinical Dosing Session and use those data to present to FDA and make the argument that a shorter duration of monitoring is appropriate. And as we go forward in Phase 3, Dan mentioned that the minimum required duration of monitoring in Phase 3 will be eight hours, but we'll also be assessing readiness for departure from a dosing session as early as hour five so that we'll be able to characterize again that response starting earlier than even the required monitoring here with the ultimate goal.

Unknown Executive: Part of a clinical dosing session, and use those data to present to FDA and make the argument that a shorter duration of monitoring is appropriate. And as we go forward into phase three, Dan mentioned that the minimum required duration of monitoring in phase three will be eight hours, but we'll also be assessing the readiness for departure from a dosing session as early as hour five, so that we'll be able to characterize again that response starting earlier than even the required monitoring here with the ultimate goal.

Dan Carlin: Ah clinical dosing session and use those data to present to FDA and make the argument that shorter duration and monitoring as appropriate and as we go forward in the phase III, Dan mentioned that the minimum required duration of monitoring in the phase II will be eight hours, but we'll also be assessing.

Daniel Karlin: Part D of each trial will be an open label 40-week extension study designed to provide important long-term data on the durability and potential retreatment profile for MM120. Voyage is anticipated to enroll approximately 200 participants who will be randomized one-to-one to receive MM120ODT 100 micrograms or placebo. Panorama is anticipated to enroll approximately 240 participants who will be randomized five-to-two-to-five to receive MM120ODT 100 micrograms, MM120ODT 50 micrograms or placebo. In accordance with FDA guidance and our regulatory discussions to date, our clinical program for MM120 continues to utilize complementary study designs across our phase two and three studies to address key methodological issues such as functional and blinding.

Speaker Change: The readiness for departure from a dosing session as always our five so that we'll be able to.

Dan Carlin: Characterize again that response starting.

Dan Carlin: Earlier than than even the required monitoring gear with the ultimate goal and we believe that in a real world setting.

Unknown Executive: We believe that in a real world setting, and when we think about labeling and the rims, there should be a required monitoring period. However, if there is one that's at the far left tail of the spectrum, physician discretion should be able to be employed. And so minimizing the fixed duration of required monitoring is something that is of interest to us that we're continuing to build a structured case around to ensure that we have data in hand. Data-Informed Arguments

Dan Carlin: And when we think about labeling in the Rems.

Dan Carlin: There should be.

Dan Carlin: Required monitoring period, if there is one thats at the far left tail of the spectrum right.

Dan Carlin: Physician discretion should be able to be employed and so minimizing the fixed duration of required monitoring is something that is of interest to us that we're continuing to build a structured case around to ensure that we.

Dan Carlin: Have data in hand to make data informed arguments the agency.

Elaine Kim: That's very helpful. Thank you so much for taking all of our questions. Thank you. Our next question comes from the line of Brian Abrahams with RBC Capital Markets. Your line is now open. Hi, good morning.

Elaine Kim: That's very helpful. Thank you so much for taking the time to answer all of our questions.

Speaker Change: That's very helpful. Thank you so much for taking all my questions.

Operator: Thank you. Our next question comes from the line of Bryan Abrahams with RBC Capital Markets. Your line is now open.

Speaker Change: Thank you.

Our next question comes from the line of Brian Abrahams with RBC capital markets. Your line is now open.

Daniel Karlin: In this regard, in the Panorama Study, we are including a 50 microgram arm to confound participants' ability to accurately assess the dose condition to which they have been randomized. We believe that this approach builds on the evidence from our phase two B study in which we demonstrated that despite functional and blinding, if all tested doses of MM120, the lower doses, 25 and 50 micrograms, did not demonstrate a meaningful clinical response. Deporting our view that the anfielditic response to MM120 is independent of functional and blinding.

Brian Abrahams: Thanks for taking my question and I really appreciate all the detail on the trial designs. Two questions from me. I guess first off, can you elaborate on the degree of follow-up and retreatment data that you think will be required prior to filing and potential approval in GAD? Is there a bar for the durability that you need to demonstrate beyond 12 weeks, or a certain proportion of patients who will need to be retreated and then followed up?

Bryan Abrahams: Hi, good morning. Thanks for taking my question and I really appreciate all the detail on the trial designs. Two questions from me. I guess first off, can you elaborate on the degree of follow-up and retreatment data that you think will be required prior to filing and potential approval in GAD? Is there a bar for the durability that you need to demonstrate beyond 12 weeks and or a certain proportion of patients who will need to be retreated and then followed up?

Brian Abrahams: Hi, good morning.

Brian Abrahams: Thanks for taking my question and really appreciate all the detail on the trial designs two questions from me I guess first off can you elaborate on the degree of follow up and re treatment data that is going that you think will be required prior to filing and potential approval in gvhd is.

Brian Abrahams: Is there.

Speaker Change: Bar for the durability that you need to demonstrate beyond 12 weeks.

Speaker Change: There are a certain proportion of patients who will need to be retreated and then I had a follow up thanks.

Daniel Karlin: While we previously observed almost eight point improvement for MM120 over placebo at week 12, both voyage and panorama have been designed to have 90% power to detect a five-point improvement over placebo based on certain statistical assumptions. Additionally, in both studies, we will use an adaptive design with an in-term blinded sample size re-estimation, which allows for an increase in sample size of to 50% in each study. This approach allows us to adjust for variability in nuisance parameters with the goal of maintaining statistical power and enhancing the interpretability of our results.

Unknown Executive: Yes, thanks so much, Brian. So our expectation is that because we are limited in the extent of the randomized control period of studies, we get rerun to pragmatic ethical issues if we keep patients with severe anxiety on no background treatment. After a single placebo intervention, for instance, beyond 12 weeks. So we run into a sort of limitation on how long we can do randomized controlled parallel group studies. So because of that, we've aligned ourselves around a 12-week duration, and even FDA's guidance talks about a 12-week duration to establish whether that didn't respond.

Brian Abrahams: Yes, thanks so much, Brian. So our expectation is that because we are limited in the extent of the randomized control period of studies, we run into pragmatic ethical issues if we keep patients with severe anxiety on no background treatment, after a single placebo intervention, for instance, beyond 12 weeks.

Yes, thanks, so much Brian so our expectation.

Speaker Change: Is that because we are <unk>.

Speaker Change: Limited and the extent of the randomized control period of studies.

Speaker Change: We got rerun too.

Speaker Change: Pragmatic ethical issues, if we keep patients with severe anxiety.

Speaker Change: No background treatment.

Unknown Executive: So we run into a sort of limitation on how long we can do randomized controlled parallel group studies. Because of that, we've... aligned around a 12-week duration. And even FDA's guidance talks about a 12-week duration to establish, and to respond. We believe those data are sufficient to demonstrate the durability and that, in terms of an initial application, we would use the extension phase of the study to inform the characteristics and the dynamics of retreatment that would be informative in labeling.

Speaker Change: After a single placebo intervention for instance, beyond 12 weeks. So we run into a sort of limitation on how long we can do randomized controlled parallel group study so in that.

Speaker Change: Because of that.

Speaker Change: Aligned around a 12 week duration and even the Fda's guidance talks about a 12 week duration to establish.

Daniel Karlin: Key elements such as inclusion, exclusion criteria will largely mirror our successful phase two B trial and GAD, and both phase three studies will recruit adults aged 18 to 74 with a diagnosis of GAD and a HAMA score of 20 or greater. During part B of the phase three studies, investigators will closely monitor patients using electronic patient reported outcomes, central radar assessed HAMAs, and clinician administered scales. Participants will be eligible for re-treatment with MM120 ODD-1 onto micrograms if their HAMA score reaches 16 or higher with up to four treatments available through parts.

Unknown Executive: We believe those data are sufficient to demonstrate the durability and that, in terms of an initial application, we would use the extension phase of the study to inform the characteristics and dynamics of retreatment that would be informative in labeling. But we certainly are focused on our primary endpoint, and in our interface meeting, we really had good discussion with the agency, and we believe we reached alignment around that 12-week primary endpoint being the most important outcome of the study to demonstrate that durability of response factors.

Speaker Change: The response.

Speaker Change: We believe those data are sufficient to demonstrate the durability and that in terms of initial application. We would use the extension phase of the study to inform the characteristics of the dynamics of three treatment there would it be informative and labeling.

Unknown Executive: But we certainly are focused on our primary endpoint, and in our interface meeting, we really had a good discussion with the agency, and we believe we reached alignment around that 12-week primary endpoint being the most important outcome of the study to demonstrate that durability of response factors. Okay, I got it. And then how much dose dependence will you need to demonstrate between 50 and 100 micrograms in order to address the potential regulatory questions about functional unblinding? Do you need to show a statistical separation between those two arms, or just a trend? Thanks. I'll hop back in the queue.

Speaker Change: But we certainly are focused on our primary endpoint.

Speaker Change: Phase two meeting really.

Speaker Change: Had good discussion with the agency and we believe reached alignment.

Speaker Change: That 12 week Pri.

Speaker Change: Primary endpoint being.

The most important outcome of this study to demonstrate that durability of response after a single treatment.

Daniel Karlin: B. Importantly, the design allows an assessment of the durability of the treatment effect, the need poor and response to retreatment and long-term safety. Key outcomes from Part B will include time to retreatment or inefficacy. We will also assess safety data on repeated treatments, average treatments per year, and response to retreatment. This information will be valuable in understanding the longer-term dynamics of M-120ODT treatment in GAD patients. Overall, both voyage and panorama are designed to be consistent with our successful phase 2B trial, including using the AMA as our primary outcome measure, with the primary endpoint for the phase 3 programs being changed from baseline to week 12, which is consistent with the durability we observed in phase 2.

Bryan Abrahams: Okay, got it. And then how much dose dependence will you need to demonstrate between 50 and 100 micrograms in order to address the potential regulatory questions about functional unblinding? Do you need to show a statistical separation between those two arms or just a trend? Thanks. I'll hop back in the queue.

Speaker Change: Okay got it and then how much dose dependence will you need to demonstrate between 50 and 100 micrograms.

Speaker Change: In order to address the potential regulatory questions about functional unwinding do you need to show a statistical separation between those two arms.

Just a trend thanks, I'll hop back in the queue.

Unknown Executive: Yeah, this is a great and really interesting question and one that we have both thought about extensively and internally as we designed our phase three program and discussed extensively with the agency. Our view is that the 50-microgram control is simply there as a control. It is not of statistical interest to us.

Speaker Change: Yes. This is a great and a really interesting question and one that we have both.

Speaker Change: Thought about extensively internally as we designed our phase III program and discussed extensively with the agency.

Speaker Change: Our view is that the 15 microgram.

Speaker Change: Control is simply there as they control it is not a statistical anxious to our.

Unknown Executive: Our Phase II study was intentionally designed to establish dose response, and that was the primary analysis of the Phase II study, which we did with a high degree of statistical significance. And as part of the MCP-MOD analysis, we come away with characterization of what we believe is the minimum clinically effective dose to achieve the clinical outcomes we're pursuing. That, coupled with the reality that in our phase two study, we saw a high degree of functional unblinding or unmasking across all active doses of the drug, but that only the two high doses achieved a clinical response. Our belief is that 100 micrograms is the go-to dose and that any other dose groups we include are not there to reestablish the dose response; they're there to try to confound patient expectancy.

Unknown Executive: Our phase two study was intentionally designed to establish dose response. That was the primary analysis of the phase two study, which we did with a high degree of statistical significance. And as part of the MCP mod analysis, we come away with characterization of what we believe is the minimum clinically effective dose to achieve the clinical outcomes we're pursuing. That, coupled with the reality that in our phase two study, we saw a high degree of functional unblinding or unmasking across all active doses of the drug, but that only the two high doses achieved a clinical response.

Speaker Change: Our phase III study was intentionally designed to establish dose response that was the primary analysis of the phase III study.

Daniel Karlin: Based on the data we collected in phase 2, we have also agreed with FDA to a reduction in treatment session duration from a minimum of 12 hours to 8 hours. This is operationally advantageous in our research program and enhances M-120's practicality in real-world settings. We will continue to collect data on monitoring times and safe parameters for determining the appropriate timing for ending sessions using structured, intentionally designed criteria to determine the time course and resolution of drug effects that could require monitoring.

Speaker Change: Which we didn't.

Speaker Change: High degree of statistical significance and as part of the MCP Mod analysis, we come away with characterization of.

Speaker Change: What we believe is the minimum clinically effective dose to achieve clinical outcomes we're pursuing.

Speaker Change: That coupled with the reality that in our phase III study we saw that.

Speaker Change: A high degree of <unk>.

Speaker Change: Functional unwinding or unmasking across all active doses of drug but that only the two high doses achieved a clinical response.

Unknown Executive: Our belief is that 100 micrograms is the go-to dose and that any other dose groups we include are not there to reestablish the dose response. They're there to try to confound patient expectations. There's been a good degree of confusion, I think, in the field about what the methodological things like an intermediate control group are there to do. And there's been a lot of confusion about that.

Daniel Karlin: We are happy to say that we remain on track and expect to initiate our first phase 3 trial voyage in GAD this year. Turning to slide 12, as Rob stated earlier, we are also excited to announce the expansion of our R&D program for M-120 into MDD. Data from our phase 2 GAD study led to our decision to pursue MDD as an additional indication for M-120, given the demonstrated potential for ending-depressant effects.

Speaker Change: Our belief is that 100 microgram is the go forward dose in that any other dose groups. We include are not there to reestablish the dose response or there to try to confound patient expectancy.

Unknown Executive: There's been a good degree of confusion, I think, in the field about what the methodological things like an intermediate control group are there to do. And there's been a lot of confusion about the differences and similarities between expectancy, bias, function, and blinding in these studies. Our view is that 50 micrograms is a dose that overlaps with 100 micrograms, a dose of clinical interest, in terms of its perceptual effects, such that patients coming into the study would, if the story we're ultimately trying to develop here is that when a patient comes into the study with obviously a degree of expectancy because patients only enroll in clinical trials if they expect something to happen.

Speaker Change: It's been a good degree of confusion I think in the field without.

Speaker Change: What the methodological thing like an intermediate control group are there to do and it's been a lot of confusion about.

Unknown Executive: The differences and similarities between expectancy, bias, functional, and blinding in these studies. Our view is that 50 micrograms is a dose that overlaps with 100 micrograms, a dose of clinical interest, in terms of its perceptual effects, such that patients coming into the study, would if the story we're ultimately trying to, develop here is that when a patient comes into the study with obviously a degree of expectancy because patients only enroll in clinical trials if they expect something to happen, will be able to inform patients that if they feel the effects of a drug during a treatment session, they may be receiving a dose that is the, quote, active dose of drug, or they may be receiving a dose that they will feel with a similar effect, but that has been shown in previous studies to not be clinically, And so we're trying to mitigate the expectancy.

Speaker Change: The differences and similarities between expectancy by a functional on blinding and these studies.

Daniel Karlin: In the 100 microgram dose group, we observed an 18.7 point improvement from baseline in the Montgomery Asperg Depression Rating Seal or Madras score at week 12. This represented a 6.4 point advantage over placebo, which was statistically significant with a p-value less than 0.01. These results are particularly encouraging, given the study wasn't powered for this endpoint, and the baseline Madras scores were lower than we would expect in patients experiencing a major depressant episode, which appeared to create a sealing effect on the response to M-120.

Speaker Change: Our view is that 50 micrograms is a dose that overlaps with 100 micrograms dose of clinical interest in terms of its perceptual effects such as the patients coming into the study.

Speaker Change: If the story, what we're ultimately trying to.

Speaker Change: Develop here is that when a patient comes into the study with obviously a degree of expecting to see because patients only enroll in clinical trials of state.

Speaker Change: Expect something to happen.

Unknown Executive: We'll be able to inform patients that if they feel the effects of a drug during a treatment session, they may be receiving a dose that is the, quote, active dose of the drug, or they may be receiving a dose that they will feel has a similar effect but that has been shown in previous studies to not be clinically accurate.

Speaker Change: We'll be able to informing patients that if they feel the effects of the drug during a treatment session.

Daniel Karlin: Slide 13 represents the phase 3 development program for M-120 and MDD, which we expect will consist of two pivotal clinical trials. Our first trial, the Emerge Study, like our pivotal trials in GAD, will be comprised of two parts. Part A, which is a 12-week randomized double-blind placebo-controlled parallel group study, assessing the efficacy and safety of a single dose of M-120 or DT versus placebo. Part B, which is a 40-week extension study during which participants will be eligible for open-label treatment with M-120 or DT, subject to certain conditions for retreatment eligibility.

Speaker Change: They may be receiving a dose that is the quote active dose of drugs or they may be receiving a dose. They will feel similar effect, but that has been shown in previous studies to not be clinically active and so we're trying to mitigate the expectancy by the real.

Unknown Executive: And so we're trying to mitigate the expectancy bias. The reality is that after a patient receives a dose, whether it be placebo 50 micrograms or 100 micrograms, they will have new knowledge of the feelings of the effect of that drug. And we fundamentally believe that the feeling of the drug is the mechanism of the drug, as is very often the case in psychiatry. And so. We do not intend or believe it is necessary to analyze statistically the 50 microgram dose.

Unknown Executive: The reality is that after a patient receives a dose, whether it be placebo 50 micrograms or 100 micrograms, they will have new knowledge of the feelings of the effect of that drug. And we fundamentally believe that the feeling of the drug is the mechanism of the drug, as is very often the case in psychiatry. And so.

Speaker Change: Is that after a patient receives a dose whether it be placebo 50, micrograms and 100 micrograms.

Speaker Change: They will have the new knowledge of the feelings of the effect of that drug and we fundamentally believe that the.

Speaker Change: Feeling of the drug is the mechanism of the drug as is very often the case in psychiatry and so we.

Unknown Executive: We do not intend or believe it is necessary to analyze statistically the 50 microgram dose. Our intent is to compare 100 micrograms versus placebo, which has been the regulatory standard for virtually all approved drugs, but certainly all approved drugs for GAD and for MDD. And again, that 50-microgram control, then, is simply there as an additional aid in functional blinding and to prove the robustness of the 100 microgram dose effect across three different study designs and three different

Speaker Change: We do not intend or believe it is necessary to analyze statistically the 50 microgram dose our intent is to compare 100 micrograms versus placebo, which has been the regulatory standard for.

Daniel Karlin: Lee. Emerge is anticipated to enroll at least 140 participants, randomized one-to-one to receive MF120 ODP 100 micrograms or placebo. The primary endpoint in a merge will be the change from baseline imager score at week six between MF120 ODP 100 micrograms and placebo. We expect to conduct a second registration trial in MDD in the future with the design and timing to be informed by the Emerge study and additional regulatory discussions. As Rob mentioned earlier, our planned execution of the MF120 program in MDD will balance this exciting opportunity across two people programs with our continued operational and financial diligence.

Unknown Executive: Our intent is to compare 100 micrograms versus placebo, which has been the regulatory standard for virtually all approved drugs, but certainly all approved drugs for GAD and for MDD. And, again, that 50-microgram control, then, is simply there as an additional aid in functional blinding and to prove out the robustness of the 100-microgram dose effect across three different study designs in three different hours. That's really helpful.

Speaker Change: Virtually all approved drugs, but certainly all approved drugs for <unk> and for MTBE.

Speaker Change: And again, Thats 50, microgram control Dennis simply there as an additional aid and functional blinding and to prove out the robustness.

Speaker Change: The 100 microgram dose effect across three different study designs in three different allocations.

Bryan Abrahams: That's really helpful. Thanks so much.

Speaker Change: That's really helpful. Thanks, so much.

Brian Abrahams: Thanks so much. Thank you. Our next question comes from the line of Rudy Lee with Lee Ring Partners. Your line is now open.

Operator: Thank you. Our next question comes from the line of Rudy Lee with Lee Ring Partners. Your line is now open.

Speaker Change: Thank you.

Speaker Change: Our next question comes from the line of Rudy Li with Leerink Partners. Your line is now open.

Rudy Lee: Hi, thanks for taking my question. Congratulations on the progress. Regarding the regulatory pathway for GAD, did you confirm with the FDA that phase 2B can be used as one of the period trials, or do you still need both phase 3 trials to file the NDA? And quickly, just a follow-up to Brian's question, with the first phase 3 GAD starting in the second half of the year, what will be the rate-limiting steps for filing considering the 40-week open-label extension trial? Thanks.

Rudy Li: Alright, Thanks for taking my question congrats on the progress.

Speaker Change: Regarding the regulatory pathway.

Reid Robison: With that, I am happy to introduce Dr. Reid Robison, who will provide his perspective on our phase three trials. Thanks, Dan. I'm very excited about the phase three development programs that you just shared. As I believe they stand to make a significant impact in the field of psychiatry. I've been personally thrilled with the results I've seen so far from MindMed's MM120 development program. The GAD phase two B results are truly impressive.

Speaker Change: <unk>.

Speaker Change: Did you confirm is the FDA the phase.

Speaker Change: Phase two b can be used as one of the pivotal trials or do you still need both phase III trials to file the NDA.

Speaker Change: And quickly just a follow up to Brian question.

Speaker Change: Our first phase III, starting in the second half of the year.

Speaker Change: What will be the rate limiting step for filing considering the 40 week open label extension trial.

Reid Robison: With MM120 exhibiting rapid and robust efficacy sustained 12 weeks after a single dose. Equally impressive is the change in Madras score from baseline to week 12 in the phase two BGAD trial participants showing improvement in comorbid depressive symptoms. For people suffering from GAD including with comorbid depression, these trials offer a beacon of hope. And I've seen firsthand how debilitating both conditions are severely impacting quality of life. Given that current standards of care falling short of meeting our patients needs, it is vital that we develop and bring to market new effective treatment options.

Rudy Lee: Thanks. Yeah, thanks so much, Rudy. In terms of the regulatory pathway, the Phase 2B study that we conducted is not a pivotal study. We intend to file with two Phase 3 studies, which are planned, the Voyage and Panorama Studies.

Unknown Executive: Yeah, thanks so much, Rudy. In terms of the regulatory pathway, the Phase 2B study that we conducted is not a pivotal study. We intend to file with two Phase 3 studies, which are planned, the Voyage and Panorama Studies.

Rudy Li: Yes, it takes all its rudy.

Speaker Change: In terms regulatory pathway. The phase <unk> study, we conducted is not a pivotal study we intend to file with two phase III studies, which are planned.

Speaker Change: Voyage in Panorama studies.

Unknown Executive: Secondly, in terms of the rate limiting, of course, we have come away from phase two with a high degree of alignment. Always, there's the caveat that many of the final decisions about what is going to be required for an NDA are reserved for discussions in a pre-NDA meeting, but our belief at this stage is that the completion of Part A of the Voyage and Panorama Studies is the rate-limiting factor to demonstrate Two Adequate Well-Controlled Studies that Demonstrate the Safety and Efficacy of the Drug.

Unknown Executive: Secondly, in terms of the rate limiting, of course, we have come away with NFA2 with a high degree of alignment. However, always there's the caveat that many of the final decisions about what is going to be required for an NDA are reserved for discussions in a pre-NDA meeting. But our belief at this stage is that the completion of Part A of the Voyage and Panorama Studies is the rate limiting factor to demonstrate, and Dr. Jeremy anderic, a true expert on all walks of life, including biochemistry.

Speaker Change: Secondly in terms of the rate limiting.

Speaker Change: Of course, we have come away with end of phase II with a high degree of alignment.

Speaker Change: Always there is the caveat that.

Speaker Change: Many of the final decisions about what is going to be required for an NDA or reserve for discussions that a pre NDA meeting.

Speaker Change: But I believe at this stage of the completion of the part a of.

Speaker Change: The voyage and Panorama studies.

Reid Robison: Three things stand out about the phase three development programs that are important from an investigator and physician perspective that I want to share with you today. First, the phase three programs are operationally efficient. Second, they enhance our ability to recruit patients. And third, the phase two and three trials are similar in design suggesting a high degree of read through as possible. All of this will make our execution of these trials more seamless.

Speaker Change: Is the rate limiting factor to demonstrate.

Speaker Change: Two adequate well controlled studies that demonstrate the safety and efficacy of the drug and that while we have an ongoing clinical pharmacology program will have part b of the study that will be informative in that process. We believe.

Unknown Executive: And that while we have an ongoing clinical pharmacology program, we'll have Part B of the studies that will be informative in that process. We believe a data cut from Part B of our Phase 3 studies would be adequate to enable this submission. Got it.

Unknown Executive: Thank you very much. Thank you, Leon. Bye, bye. Bye, bye. Bye, bye. Bye. Bye. Bye. Good to see you react well. Adequate, to enable this.

Speaker Change: Data cut from part B of our phase III studies would be.

Speaker Change: Adequate.

Speaker Change: To enable a submission.

Rudy Lee: Got it. Very helpful. Thanks. Thank you.

Rudy Lee: Very helpful. Thanks. Thank you. Our next question comes from the line of Francois Brisebois with Oppenheimer. Your line is now open.

Speaker Change: Got it very helpful. Thanks.

Reid Robison: I'll break all three attributes down further. From an operational perspective, the key design elements of both phase three programs make them efficient to run. This operational ease is crucial as it allows my team to manage the trials effectively while maintaining scientific rigor. In the GAD trials, reducing treatment session monitoring from 12 to 8 hours is an example of this, making delivery of MM120 more practically feasible, mirroring how I would expect to treat patients if MM120 is approved.

Operator: Thank you. Our next question comes from the line of Francois Brisebois with Oppenheimer. Your line is now open.

Speaker Change: Thank you. Our next question comes from the line of French Swab first voice with Oppenheimer. Your line is now open.

Francois Brisebois: Hi, this is Dan on behalf of Frank. Thanks for taking our questions. I guess, related to some of the questions that have been going on, could you talk a little bit more about the end of phase 2 meeting, especially considering the Lycos adcom, whether there were any issues or concerns that were raised during the meeting, and thanks for all the color around the strategies that you've taken. But were there any surprises during the meeting? Anything you want to add?

Francois Brisebois: Hi, this is Dan on behalf of Frank. Thanks for taking our questions. I guess, related to some of the questions that have been going on, could you talk a little bit more about the end of phase 2 meeting, especially considering the Lycos adcom, whether there were any issues or concerns that were raised during the meeting? And thanks for all the color around the strategies that you've taken. But were there any surprises during the meeting? Anything you want to add?

Speaker Change: Hi, This is Dan on for Frank Thanks for taking our questions.

Speaker Change: I guess related to some other questions that have been going on.

Speaker Change: Could you talk a little bit more about the end of phase II meeting, especially considering the lycos ad com.

Speaker Change: There were any issues or concerns that were raised during the meeting and thanks for all the.

Reid Robison: Another significant advantage of these trials is our ability to efficiently recruit and enroll patients. While the GAD program will start earlier than the MDD program, having both programs run concurrently, we can tailor recruitment efforts to match specific diagnoses. GAD and MDD have overlapping symptoms. And this approach improves our ability to put patients in whichever program is appropriate for their clinical presentation, thereby accelerating enrollment.

Speaker Change: Color around these strategies that you've taken but.

Speaker Change: Was there any surprises during the meeting.

Speaker Change: The thing you want to add there.

Unknown Executive: Yes, thanks so much for the question, Dan. At the end of phase two, we got fortunate in the sequencing of the regulatory events that have happened this year. So we had our end of phase two meeting very shortly after the LICAS advisory committee, which we thought was a great benefit because it allowed us to integrate thinking and feedback and, obviously, the public conversation from the Lycos Adcom into our discussions with the agency. And something that we greatly valued was being able to learn from other happenings in the field to make sure we're pursuing a strategy we're really confident in. So we had a great discussion I think we came away with a higher degree of alignment. There are no surprises.

Speaker Change: Okay.

Speaker Change: Yes. Thanks, so much for your question Dan.

Speaker Change: We got fortunate.

Speaker Change: Sequencing of the regulatory events that have happened. This year. So we had our end of phase II meeting.

Speaker Change: Very shortly after like US Advisory Committee, which we thought was a great benefit because it allowed us to integrate.

Speaker Change: Thinking and feedback and obviously the public conversation from like Us AD com into our discussions with the agency and something that we.

Reid Robison: Lastly, the design of these trials directly builds on MindMed's Phase 2B GAD trial results. This continuity enables us to build on existing data, enhancing the ability to validate prior findings, and the efficacy and safety of MM120 ODT with a high degree of consistency. In addition, the 12-week primary endpoint for the Phase 3 trials in GAD should provide evidence on durability, which I believe is the utmost importance to physicians and patients. I'm looking forward to getting these Phase 3 trials started.

Hi.

Speaker Change: Greatly value to us be able to learn from other happenings in the field to make sure we.

Speaker Change: Pursuing a strategy we are really confident.

Speaker Change: We had a great discussion agency I think.

Speaker Change: Kimberly with a high degree of alignment.

Unknown Executive: There's certainly a shared dialogue around trying to solve complex issues, and I think we're incredibly appreciative of the agency in terms of their willingness to engage in those conversations, their willingness to be pragmatic and to tackle these complex issues in a way that doesn't slow down development. Our view coming out of that meeting is that with the plan we have designed, we will have a strong case to be made both to the agency and to any commentators or observers, whether that be an advisory committee or in peer-reviewed publications and the broader narratives, we can come up with a compelling argument for both the value proposition and the safety and efficacy of the drug that would allow us to then proceed to a submission.

Unknown Executive: There is certainly a shared dialogue around trying to solve complex issues. And I think we're incredibly appreciative of the agency in terms of their willingness to engage in those conversations, their willingness to be pragmatic and to tackle these complex issues in a way that doesn't slow down development. Our view coming out of that meeting is that with the plan we have designed, we will have a strong case to be made both to the agency and to any commentators or observers, whether that be an advisory committee or in peer-reviewed publications and the broader narratives, we can come up with a compelling argument for both the value proposition and the safety and efficacy of the drug that would allow us to then proceed to a submission. No surprises, I would say that we had a very constructive dialogue and came up with a clear path forward.

Speaker Change: There are no surprises there is certainly a shared dialog around.

Speaker Change: Trying to solve complex issues and I think we're incredibly appreciative of the agency in terms of.

Reid Robison: They have the potential to pave the way for significant advancements in treating GAD and MDD, and I'm eager to see the results, so MindMed can move forward with the development of MM120 and make a meaningful impact on patient's lives.

Speaker Change: Their willingness to engage in those conversations or willingness to be pragmatic in the tackle these complex issues in a way that doesn't slow down.

Speaker Change: <unk>.

Speaker Change: Our view coming out of that meeting that.

Robert Barrow: And with that, I'll turn the call back over to Rob. Thank you, Dr. Robison. We're excited to get started a grateful to be aligned on our pivotal programs of clinicians like you.

Speaker Change: With the plan we have design, we will have a strong case to be made both to the agency and two.

Speaker Change: Any commentary or observers are.

Speaker Change: Whether that be an advisory committee or <unk>.

Robert Barrow: I'll now turn to our financial results with a quarter-ended June 30th, 2024, which are highlighted on side 15. As of June 30th, 2024, the company had cash and cash equipments totaling $243.1 million, compared to $99.7 million, as of December 31st, 2023. We believe that our cash and cash equipments, as of June 30th, 2024, combined with the proceeds from our recently closed financing, will be sufficient to fund our operations into 2027. Based on our current operating plan and anticipated R&D milestones, we expect this cash runway to extend at least 12 months beyond the top-line data readouts for our first Phase III trial in MM120 and GAD.

Speaker Change: Peer reviewed publications in the broader narrative that we can go over the compelling argument for them.

Speaker Change: Both the value proposition in the safety and efficacy of the drug that would allow US to then proceed to a submission. So no surprises I would say that we had a very constructive dialogue and came out with a clear path forward.

Unknown Executive: No surprises, I would say that we had a very constructive dialogue and came up with a clear path forward. Great, and just as a quick follow-up, the dose relationship being going after 50 micrograms and 100 micrograms, does the FDA generally agree with that approach that demonstrating a dose relationship does address the expectancy bias or functional blinding issue?

Francois Brisebois: And just as a quick follow-up, the dose relationship being, yeah, going after 50 micrograms and 100 micrograms, does the FDA generally agree with that approach that demonstrating a dose relationship does address the expectancy bias or functional blinding issue?

Speaker Change: Great and just as a quick follow up.

Speaker Change: The dose relationship being.

Speaker Change: Going after 50, microgram and 100 microgram.

Speaker Change: The FDA generally agree with that approach that.

Speaker Change: Demonstrating a dose relationship does address the expectancy bias or touch on blinding issue.

Unknown Executive: I think I understand your question. So we presented our view and our logic and our strategy during the phase two meeting and in our phase three protocols. And we're certainly confident in the path forward and our plans to address these issues.

Francois Brisebois: I think I understand your question. So we presented our view, our logic, and our strategy during the phase two meeting and in our phase three protocols. And we're certainly confident in the path forward and our plans to address these issues. I think it's really important for us to highlight the reality that this is a very common issue in psychiatry, while there's been a sort of spotlight on the matter of expectancy and functional unblinding.

Robert Barrow: For the six months ended June 30th, 2024, that cash used in operating activities was $36.6 million, compared to $27.2 million for the same period in 2023. Research and development expenses were $14.7 million to the quarter-ended June 30th, 2024, compared to $14.8 million for the same period in 2023, representing a decrease of $0.1 million. The decreases primarily due to decreases of $0.5 million in expenses related to our MM120 GAD program, and a decrease of $2 million in expenses related to pre-clinical activities.

Speaker Change: I think I understand your question. So we presented our view and our logic and our strategy either in the phase II meeting and in our phase III protocols and we're certainly confident in the path forward in our plans to address these issues I think it's it's re.

Unknown Executive: I think it's really important for us to highlight the reality that this is a very common issue in psychiatry while there's been a sort of spotlight shown on the matter of expectancy and functional unblinding. This is how psychiatric drugs work, particularly for mood and anxiety disorders. 2mg of Xanax is fully functionally unblinded.

Really important.

Speaker Change: To for us to highlight the reality that this is a very common issue in psychiatry, while there's been a sort of a spotlight shown on the matter of expectancy and functional on blinding.

Francois Brisebois: This is how psychiatric drugs work, particularly for mood and anxiety disorders; two milligrams of Xanax is fully functionally unblinded. And based on historical research, even SRIs have something like a 70% incidence of patients being able to correctly guess that they're on an SRI. It's only that under 5% of historical studies of SRIs have actually asked the question or appeared to look.

Speaker Change: This is how psychiatry drugs work, particularly for mood and anxiety disorders.

Speaker Change: Two milligrams of <unk> is fully functionally unblinded.

Unknown Executive: And based on historical research, even SRIs have something like a 70% incidence of patients being able to correctly guess that they're on an SRI. It's only under 5% of historical studies of SRIs that actually ask the question or appear to look. So while this is being scrutinized in our field, it's not unusual. And in that, we believe that we should follow the well-established precedent for evidence required to establish the safety and efficacy of drugs, which is demonstrating statistically and clinically significant improvement over a placebo.

Speaker Change: And based on historical research, even sri's have something like 70%.

Robert Barrow: Partially offset by an increase of $1 million in internal personnel costs as a result of an increasing research and development capacity, an increase of $1.4 million in expenses related to our MM402 program. We do anticipate R&D expenses to ramp up in the second half of this year, and in 2025, as we get the Phase III studies in GAD and MDD up and running. General and administrative expenses were $9.8 million for the quarter-ended June 30th, 2024, compared to $14.4 million for the same period in 2023, a decrease of $4.6 million.

Speaker Change: Incidents of patients being able to correctly guessed that theyre rns Ray, it's only that under 5% of historical studies of <unk>. So it actually.

Unknown Executive: So while this is being scrutinized in our field, it's not unusual. And in that, we believe that we should follow the well-established precedents for evidence required to establish the safety and efficacy of drugs, which is demonstrating statistically and clinically significant improvement over a placebo. That's what our program is designed around, and while we include many, many aspects to try to mitigate and address the questions around expectancy and functional unblinding, we have alignment, we believe, with the agency on the path forward. Again, this is just something that is not all that new, even though it's been highly talked about over the last couple of years.

Speaker Change: Ask the question are appeared to look so while this is being scrutinized and our field. It is not unusual and in that we believe that we should follow the well established precedence for evidence required to establish the safety and efficacy of drugs, which is demonstrating.

Speaker Change: Statistically and clinically significant improvement over placebo, that's what our program is designed around and while we include many many aspects to try to mitigate and address the questions around expectancy and functional unwinding. We have alignment we believe with the agency on the path forward again. This is something that is not all of that new even though it has been.

Unknown Executive: That's what our program is designed around, and while we include many, many aspects to try to mitigate and address the questions around expectancy and functional unblinding, we have alignment, we believe, with the agency on the path forward. Again, this is just something that is not all that new, even though it's been highly talked about over the last couple of days.

Robert Barrow: The decrease was primarily attributable to professional services and expenses during the three months in the June 30th, 2023. Lee, Relating to the proxy contestant's connection with our 2023 annual general meeting of shareholders, partially offset by increased stock-based compensation expense. The company's net loss of the quarter ended June 30, 2024 was $5.9 million, compared to $29.1 million for the same period in 2023. The decrease was primarily due to changes in the fair value of 2022, US dollar financing worth, a $15 million.

Speaker Change: Hi, they talked about it over the last couple of months.

Francois Brisebois: Great. Thanks for taking our questions. Thank you. As a reminder to ask a question at this time, please press star 11 on your touchtone telephone. Our next question comes from the line of Joel Beattie.

Speaker Change: Great. Thanks for taking our questions.

Speaker Change: Thank you.

Speaker Change: To ask a question at this time, please press star one one touchstone telephone.

Operator: Thank you. As a reminder to ask a question at this time, please press star 11 on your touchtone telephone. Our next question comes from the line of Joel Beattie with RW Baird. Your line is now open.

Speaker Change: Our next question comes from the line of Joel Beatty with RW Baird. Your line is now open.

Speaker Change: Good morning. This is Christopher Chen on for Joel Thanks for taking our question.

Joel Beattie: Thanks for taking our question. In terms of 120, I know your primary focus is the domestic market, but have you started at all analyzing ex-US opportunities? And if so, how would you characterize that analysis?

Speaker Change: In terms of 120.

Speaker Change: Your primary focus is the domestic market but.

Speaker Change: Have you started at all analyzing ex U S opportunities and if so how would you characterize that analysis. Thank you.

Robert Barrow: We're projecting top-line part A readouts for these pivotal trials, starting with voyage in the first half of 2026, and then Tenerama in a merge in the second half of 2026. These anticipated milestones represent significant value inflection points for our company, and could potentially bring us closer to providing novel and highly differentiated treatment options for patients with GAD and MDD. We believe that the evidence generated to date on MM120 validates our scientific understanding of MM120's mechanisms of action and shows potential for an emerging best-in-class product profile compared to today's standards of care.

Unknown Executive: Yeah, thanks so much, Christopher. We have started to analyze the XUS markets and engage in some dialogue about those opportunities. We do not, at this time, intend to develop a sales force or launch the drug in most ex-U.S. markets. Our focus would be on the U.S. markets, and we're certainly open to engaging and discussing collaborations and partnerships in other countries when it makes sense about the potential commercialization of those markets. But obviously, the dynamics of, for instance, launching a drug in Europe and the pricing and various considerations there would be, and we think a lower return on investment than our focus on launching the drug in the U.S. primarily.

Unknown Executive: Thank you. Yeah, thanks so much, Christopher. We have started to analyze XUS markets and engage in certainly some dialogue about those opportunities. However, we do not at this time intend to develop a sales force or launch the drug, and in most ex-US markets, our focus would be on the US markets. And we're certainly open to engaging and discussing collaborations and partnerships outside the US when it makes sense about the potential commercialization of those markets. But obviously, the dynamics of, for instance, launching a drug in Europe and the pricing and various considerations there would be. We think a lower return on investment than our focus on launching the drug in the U.S. primarily.

Speaker Change: Yes, Thanks Christopher.

Speaker Change: We have started to <unk>.

Speaker Change: Annualized ex U S markets and engaging.

Speaker Change: Some dialogue about those opportunities.

Speaker Change: We do not at this time intend to.

Speaker Change: Develop a salesforce or launch the drug.

Speaker Change: And in most ex U S markets, our focus would be on the U S markets and were certainly open to engaging and discussing collaborations and partnerships ex U S. When it makes sense about the potential commercialization of those markets, but obviously the dynamics of for instance, launching a drug in Europe and the pricing.

Speaker Change: Various considerations there would be.

Speaker Change: We think.

Speaker Change: Lower return on investment and our focus on launching the drug in the U S primarily.

Operator: Thank you. Thank you. Our next question comes from the line of Sumant Kulkarni with Kennecourt Genuity, LLC. Your line is now open.

Speaker Change: Thank you.

Joel Beattie: Thank you. Thank you. Our next question comes from the line of Sumant Kulkarni with Kennecourt Genuity, LLC. Your line is now open.

Operator: Thank you. Our next question comes from the line of Sumant Kulkarni with Kinnacore Genuity, LLC. Your line is now open. Good morning. Thanks for taking my questions.

Speaker Change: Thank you.

Robert Barrow: We are excited to advance our pipeline and to be on the cost of moving forward with our pivotal development programs for MM120 in both GAD and MDD. With strong marks protection and IP strategies, and a cash runway in the 2027 and 12 months beyond our first SA3 readout, we are well positioned to execute on our strategy.

<unk> Kulkarni: Our next question comes from the line of <unk> Kulkarni with Canaccord Genuity LLC. Your line is now open.

Sumant Kulkarni: Good morning, thanks for taking my questions. Do you have any specific targets for prior use of LSD or other psychedelics as inclusion criteria in your phase three trials? And in the open-label portions of your studies, how do you ensure integrity is maintained to make sure that any potential durability of effect is more purely attributable to MM120 versus other treatments or therapies? Thanks so much, Sumant. I'll turn it over to Dan Karlin to address that one. Yeah, so thanks, Sumant.

Kulkarni: Good morning, Thanks for taking my questions do you have any specific targets for prior use of LSD there. Thank you.

Alex: Alex as inclusion criteria in your phase III trials and in the open label portions of your studies, how do you ensure integrity is maintained to make sure that any potential durability of effect is more purely attributable to $1 20 versus other treatments are canopy.

Robert Barrow: As we conclude, I want to extend my sincere appreciation and gratitude to the critical work and careful execution that has brought my med ever closer to realizing our mission. I would like to thank our highly talented and deeply committed team, our research collaborators and clinical investigator teams, our investors, and the many other individuals who have been supported, 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 to many individuals living with brain health disorders.

Sumant Kulkarni: Thanks so much, Sumant. I'll turn it over to Dan Karlin to address that. Yeah, so thanks, Sumant.

Speaker Change: Yes, thanks, so much to mark.

Alex: Turn that over to Dan Carlin to address that one.

Daniel Karlin: For prior psychedelic or LSD exposure, we have explicit exclusion criteria related to recent use and any heavy use over a number of years preceding enrollment. So while we don't specify beyond that from an inclusion exclusion perspective, we certainly want to be sure that we're getting folks who aren't, you know, currently using or recent heavy users. We also will, in phase three, track use history, of course. And what we found in phase two was, in essence, with these criteria, because we're moving into phase three, very much with inclusion and exclusion nearing phase two, what we found was about a 15 to 20% historical usage in the population we ended up enrolling, which interestingly aligns almost exactly with epidemiological findings on use in the general population. So, as ever, we want to get a population that's as representative of the overall GAD population as possible.

Alex: Yes, so thanks, Tim for prior psychedelic or LSD exposure, we have.

Blissett exclusion criteria related to.

Alex: Recent use and.

Speaker Change: And any heavy use silver over a number of years preceding enrollment so while we don't specify.

Unknown Executive: With that, I look to thank you all again for joining today.

Speaker Change: Beyond that.

Unknown Executive: The team and I are happy to take any questions. Thank you. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To draw your question, please press star 1-1 again. Please stand by, we will compile the Q&A roster.

Speaker Change: Inclusion exclusion.

Speaker Change: Perspective, we certainly want to be sure that we're getting folks who aren't currently using or recent heavy users.

Speaker Change: We also will and phase two would be track use history of course, and what we found in phase two was in essence with with these criteria because again, we're moving into phase III very much with the inclusion exclusion nearing phase II, what we found was about a 15% to 20% historical.

Elaine Kim: Our first question comes from the line of Charles Duncan with Cantor. Your line is now open. Hi, this is Elaine Jim on for Charles. Thank you for taking our questions. This is a two-parton for the first question. It's an open label 100 microgram dose to help maintain response or remission rates versus having patients continue the 50 microgram dose in the 40 week follow-up. And for my second question, it's a reduction of the treatment session to 8 hours from 12 hours. What information enable this decision to be agreed by the FDA and what requirements for patient care following the 8-hour treatment session? What requirements will be implemented? Thank you. Yeah, thanks so much, Elaine.

Speaker Change: Usage in the population, we ended up enrolling which interestingly aligns almost exactly with epidemiological findings unused in the general population so as ever we want to get a population that is representative of the overall <unk> population as possible and we think we did that in phase III and we'll continue to do that.

Robert Barrow: To the first question, so when we're designing the phase three program, continuing patients are, I think two things you're worth pointing out would be open label, Part B, portion of the study, action to the extension, Part B of the study, first is that we've been really thoughtful about how we analyze and think about the extension phase of the study, because until patients actually receive open label treatment in that Part B of the study, they remained in a blinded status, until someone had actually received open label drugs, while it's an extension study with open label opportunities for treatment, they haven't actually received anything, which is unusual here, certainly wouldn't be the case in the case of an open label extension of a daily medicine. The selection of 100 micrograms is because it is the clinical dose of interest, relying on our phase two B results.

Daniel Karlin: And we think we did that in phase two, and we'll continue to do that in phase three. As far as data integrity, attribution of efficacy, the extension phase that we discussed and that Rob expanded on a bit in a prior question is really going to be run very much the same way that the blind phase is run, so that in all of our studies, we watch people out of background therapy. If folks are engaging in psychotherapy outside of the trial, that has to be sort of stable and unchanging for a period of time, both before and during the trial.

Daniel Karlin: And we think we did that in phase two, and we'll continue to do that in phase three. As far as data integrity, attribution of efficacy, the extension phase that we discussed and that Rob expanded on a bit in a prior question is really going to be run very much the same way that the blind phase is run, so that in all of our studies, we watch people out of background therapy. If folks are engaging in psychotherapy outside of the trial, that has to be stable and unchanging for a period of time, both before and during the trial.

Speaker Change: Phase III as.

Speaker Change: As far as.

Data integrity attribution of efficacy.

Speaker Change: The extension phase that we discussed and Rob.

Speaker Change: Landed on a bit in a prior question is really.

Rob: Going to be run very much the same way that the blinded basis rent so that in.

Speaker Change: All of our studies, we watch people out of background therapy, if folks are engaging in psychotherapy outside of the trial that has to be stable and unchanging for a period of time before and through the trial and we will continue to.

Daniel Karlin: And we'll continue to enforce those same restrictions on outside treatment, other treatments, and newly added psychotherapy through the entire extension phase. So while we do give folks the opportunity to get either dose for the first time if they started in a placebo arm or a control arm, the expectation is that the only treatment that they're receiving, the only new or changed treatment that they're receiving, and the only pharmacological treatment that they're receiving through the entire extension phase is MM120.

Daniel Karlin: And we'll continue to enforce those same restrictions on outside treatment, other treatments, and newly added psychotherapy through the entire extension phase. So while we do give folks the opportunity to get either dosed for the first time if they started in a placebo arm or a control arm, the expectation is that the only treatment that they're receiving, the only new or changed treatment that they're receiving, and the only pharmacological treatment that they're receiving through the entire extension phase is MM120.

Speaker Change: Enforced those same.

Speaker Change: Restrictions on outside treatment other treatments.

Speaker Change: I didn't think the therapy through the entire extension phase so while we do give folks the opportunity to get either dose for the first time that they started in a placebo arm or a control arm.

The expectation is that the only treatment that they are receiving.

Speaker Change: The only new where change treatment that theyre receiving in the Omi pharmacological treatment that they are receiving through the entire extension phase has there been 120.

Speaker Change: Thank you.

Operator: Thank you. Thank you. And I'm currently showing no further questions in the queue. This does conclude.

Operator: Thank you, and I'm currently showing no further questions in the queue. This does conclude today's conference call. Thank you all for joining, and you may now disconnect.

Speaker Change: Thank you.

Speaker Change: And I'm currently showing no further questions in the queue. This does conclude today's conference call. Thank you all for joining and you may now disconnect.

Robert Barrow: We believe 100 microgram dose is our GoFord dose and our modeling from the phase two B results, and the MCP model analysis we conducted there suggests that it is the dose to take forward and the efficacious dose we should be studying, whereas the 50 microgram dose is there simply as a functional mask, it's an additional control to aid in addressing the concept of functional blinding. That's the rationale. We're not interested in 50 micrograms as a clinical dose to take forward or to be submitted at this time.

Speaker Change: Okay.

Speaker Change: [music].

Robert Barrow: The intent is to characterize what happens in a more real world-like setting where patients would have the opportunity for retreatment upon the reemergence or the continued inefficacy after the initial phase of the study. In terms of part B or question or the second part of question, we presented data from very early on, and as has been an point of discussion since the advisory committee earlier this year, we have been very intentional about designing structured criteria for when patients would be allowed to end their monitoring session.

Robert Barrow: In phase two, we went to the extreme conservatism and used the DSM-5 definition of hallucinogen intoxication. So patients had to be cleared by meeting effectively no signs of hallucinogen intoxication. As we've continued our regulatory discussions and our thinking is further evolved and been informed by the data, we have refined that checklist to be much more modeled around what we would expect to be representative of a real-world, rent-like checklist for reticentations after a dosing session.

Speaker Change: Okay.

[music].

Robert Barrow: So we presented data, we collected a time course of those assessments in our phase two B study to characterize exactly the sort of temporal curve of when patients would be able to be, it's in a clinical dosing session, and used those data to present FDA and make the argument that shorter duration of monitoring is appropriate. And as we go forward in the phase three, damn it's in that the minimum required duration of monitoring in the phase three will be eight hours, but we'll also be assessing the readiness for departure from a dosing session as early as hour five, so that we'll be able to characterize again that response starting, earlier than even the required monitoring here.

Robert Barrow: We also make goal, and we believe that in a real world setting, and when we think about labeling and rims, there should be a required monitoring period, if there is one that's at the far left tail of the spectrum, physician discretion, should be able to be employed. And so minimizing the fixed duration of required monitoring is something that is of interest to us, that we're continuing to build a structured case around to ensure that we have data in hand to make the data informed arguments to the agency. That's very helpful. Thank you so much for taking all of our questions. Thank you.

Brian Abrahams: Our next question comes from the line of Brian Abrahams with RBC, Capitol Market. She won't open. Hi, good morning.

Brian Abrahams: Thanks for taking my question and really appreciate all the detail on the trial designs. Two questions from me. I guess first off, can you elaborate on the degree of follow up and re-treatment data that is going that you think will be required prior to filing and potential approval in GAD? Is there a bar for the durability that you need to demonstrate beyond 12 weeks? And or a certain proportion of patients who will need to be re-treated and then had a follow up?

Brian Abrahams: Yes, thanks so much, Brian. So our expectation is that because we are limited in the extent of randomized and full period of studies, we run to pragmatic and ethical issues if we keep patients with severe anxiety on no background treatment. And after a single placebo intervention, for instance, beyond 12 weeks. So we run into a sort of limitation on how long we can do randomized, controlled parallel group study. So in that, because of that, we've aligned around a 12 week duration and even FDA's guidance talks about a 12 week duration to establish the response.

Brian Abrahams: We believe those data are sufficient to demonstrate the durability and that in terms of initial application, we would use the extension phase of the study to inform the characteristics, the dynamics of re-treatment that would be informative in labeling. But we certainly are focused on our primary endpoint and in our individual meeting really had good discussion with the agency and we believe reached alignment around that 12 week primary endpoint being the most important outcome of the study to demonstrate that durability and the response after a single treatment.

Brian Abrahams: Okay, got it. And then how much dose dependence will you need to demonstrate between 50 and 100 micrograms in order to address the potential regulatory questions about functional on lining? Do you need to show a statistical separation between those two arms or just a trend? Thanks. I'll hop back in the queue. Yeah, this is a great and a really interesting question and one that we have both. Jeff, thought about extensively and internally as we designed our Phase 3 program and discussed extensively with the agency.

Brian Abrahams: Our view is that the 50 microgram control is simply there as a control. It is not a statistical interest to us. Our Phase 2 study was intentionally designed to establish dose response, that was the primary analysis of the Phase 2 study, which we did with a high degree of statistical significance. And as part of the MCP mod analysis, we come away with characterization of what we believe is the minimum clinically effective dose to achieve clinical outcomes we're pursuing.

Brian Abrahams: That coupled with the reality that in our Phase 2 study, we saw that a high degree of functional unblinding or I'm asking across all active doses of drug, but that only the two high doses achieved a clinical response. Our belief is that 100 microgram is the go-for dose and that any other dose groups we include are not there to reestablish the dose response. They're there to try to confound patient expectancy. There's been a good degree of confusion I think in the field about what the methodological things like an intermediate control group are there to do.

Brian Abrahams: There's been a lot of confusion about the differences and similarities between expectancy by a functional unblinding in these studies. Our view is that 50 micrograms is a dose that overlaps with 100 micrograms, the dose of clinical interest, in terms of its perceptual effect, such that patients coming into the study, the story will also be trying to develop here is that when a patient comes into the study with obviously a degree of expectancy because patients only enroll in clinical trials as they expect something to happen, we'll be able to inform patients that if they feel the effects of a drug during a treatment session, they may be receiving a dose that is the quote, active dose of drugs, or they may be receiving a dose that they will feel with a similar effect but that has been shown in previous studies to not be clinically active.

Brian Abrahams: And so we're trying to mitigate the expectancy by it. The reality is that after a patient receives a dose, whether it be placebo 50 micrograms or run 100 micrograms, they will have the new knowledge of the feelings of the effect of that drug. And we fundamentally believe that the feeling of the drug is the mechanism of the drug, as is very often the case with psychiatry. And so we do not intend or believe it is necessary to analyze statistically the 50 microgram dose.

Brian Abrahams: Our intent is to compare 100 micrograms versus placebo, which has been the regulatory standard for virtually all approved drugs, but certainly all approved drugs for GAD and for MDD. And again, that 50 micrograms controlled then is simply there as an additional aid and functional blinding and to prove out the robustness of the 100 microgram dose effect across three different study designs and three different Relications.

Unknown Executive: That's really helpful. Thanks so much.

Unknown Executive: Thank you.

Rudy Lee: Our next question comes from the line of Rudy Lee with Learing Partners, she'll let us know open. Hi, thanks for taking my question. Congrats on the progress. Regarding the regulatory pathway in GAB. Did you confirm with the FDA that the phase 2B can be used as one of the periodo trials or do you still need both phase 3 trials to file the FDA and quickly just follow up to Brian's question with the first phase 3GAD starting in the second half of the year. Well, we'll be the limiting steps we're filing considering the 40-week open labeled tension trial. Thanks. Yes, it takes so much for Rudy.

Robert Barrow: In terms of regulatory pathway, the phase 2B study that we conducted is not a pivotal study. We intend to file with two phase 3 studies which are planned the voyage and panorama studies. Secondly, in terms of the rate limiting, of course, we have a couple of ways with the phase 2 with a high degree of alignment. There's always the caveat that many of the final decisions about what is going to be required for an NDA or reserve for discussions at a pre-NDA meeting.

Robert Barrow: But I believe at this stage is that the completion of the part A of the voyage and panorama studies is the rate limiting factor to demonstrate two adequate well controlled studies that demonstrate the safety and efficacy of the drug. And that while we have an ongoing clinical pharmacology program, we'll have part B of the studies that will be informative in that process. We believe a data cut from part B of our phase 3 studies would be adequate to enable this mission. Got it. Very helpful. Thanks. Thank you.

Franois Brisebois: Our next question comes from the line of Francois birth voice with up in hammer. Your line is now open. Hi, this is Dan on for Frank. Thanks for taking our questions. I guess related to some of the questions that have been going on.

Robert Barrow: Could you talk a little bit more about the end of phase 2 meeting, especially considering the like goes adcom, whether there were any issues or concerns that were raised during the meeting. And thanks for all the color around the strategies that you've taken, but was there any surprises during the meeting, anything you want to add this? Yes, thanks so much for the question, Dan. I'm going to say to you, we got fortunate in the sequencing of regulatory events to the path in this year.

Robert Barrow: So we had our end of phase 2 meeting very shortly after the like this advisory committee, which we thought was a great benefit because it allowed us to integrate the thinking and feedback. And obviously the public conversation from the like us adcom into our discussions with the agency and something that we greatly valued was to be able to learn from other happening from the field to make sure we're pursuing a strategy really come, at the end.

Robert Barrow: So when we had a great discussion with the agency, I think we came away with a higher degree of alignment. I would say there are no surprises. There's certainly a shared dialogue around trying to solve complex issues. I think we're incredibly appreciative of the agency in terms of their willingness to engage in those conversations, the willingness to be pragmatic in the tackle these complex issues in a way that doesn't slow down development.

Robert Barrow: Our view coming out of that meeting is that with the plan we have designed, we will have a strong case to be made both to the agency and to any commentators or observers or whether that be an advisory committee or in peer review publications and broader narratives that we can come over the compelling argument for both of the eye proposition and the safety and efficacy of the drug that would allow us to then proceed to a submission. So no surprises.

Robert Barrow: I would say that we had a very constructive dialogue and came over with a clear path forward. Great.

Robert Barrow: And just as a quick follow-up, the dose relationship being going after 50 microgram and 100 microgram. Does the FDA generally agree with that approach that demonstrating a dose relationship, just address the expectancy bias or a constant blinding issue? I think I understand a question. So we presented our view and our logic and our strategy. I had her in the phase two meeting and in our phase three protocols and we're certainly confident in the path forward and in our plans to address these issues.

Robert Barrow: I think it's really important for us to highlight the reality that this is a very common issue in psychiatry, while there's been a spotlight shown on the matter of expectancy and functional blinding. This is how psychiatry drugs work, particularly for mood and anxiety disorders. Two milligrams of Xanax is fully functionally unwinded. And based on historical research, even SRIs have something of like a 70% incidence of patients being able to correctly guess they're on SRI.

Robert Barrow: It's only that under five percent of historical studies of SRIs have actually asked the question or appeared to look. So while this is being scrutinized in our field, it's not unusual. And in that, we believe that we should follow the well established precedence for evidence required to establish the safety of an efficacy of drugs, which is demonstrating statistically and critically significant improvement over a placebo. That's what our program is designed around.

Robert Barrow: And while we include many, many aspects to try to mitigate and address the questions around expectancy and functional blinding. We have a line that we believe with the agency on the kind of Ford. Again, this is just something that is not all that new even though it's been highly talked about over the last couple of months. Thanks for taking all questions. Thank you.

Unknown Executive: As a reminder to ask a question at this time, please press star 11 or you touched on telephone.

Christopher Chen: Our next question comes from the line of Joel Beatty with RW Barrett. Your line is now open. Good morning.

Robert Barrow: This is Christopher Chenon for Joel. Thanks for taking our question. In terms of 120, I know your primary focus is the domestic market but have you started at all analyzing XUS opportunities and if so, how would you characterize that analysis? Thank you. We have started to analyze XUS markets and engage in some dialogue about those opportunities. We do not at this time intend to develop a sales force or launch the drug in most XUS markets.

Robert Barrow: Our focus would be on the US markets and we're certainly open to engaging and discussing collaborations and partnerships. XUS when it makes sense about its intercommercialization in those markets but obviously the dynamics of for instance launching a drug in Europe and the pricing and various considerations there would be, you know, we think lower return on investment than our focus on launching the drugs in the US primarily. Thank you.

Sumant Kulkarni: Our next question comes from the line of Sumat Kokarni with Kennencore Genuity LLC. Your line is now open.

Daniel Karlin: Good morning. Thanks for taking my questions. Do you have any specific targets for prior use of LSD or other psychedelics as inclusion criteria and your phase three trials and in the open label portions of your studies. How do you ensure integrity is maintained to make sure that any potential durability of effect is more purely attributable to MM120 versus other treatments or therapy? Thanks so much. I'll turn that over to Dan Carlin to address that one.

Daniel Karlin: Yeah, so thanks a lot. For prior psychedelic or LSD exposure, we have explicit exclusion criteria related to recent use and any heavy use over a number of years preceding enrollment. So we don't specify beyond that from an English and exclusion perspective. We certainly want to be sure that we're getting folks who aren't currently using or recent heavy users. We also will in phase three track use history, of course. And what we found in phase two was in essence with with these criteria because what we're moving into phase three very much with English and exclusion hearing phase two, what we found was about a 15 to 20% historical usage in the population.

Daniel Karlin: This is representative of the overall GAD population as possible. We did that in phase two and we'll continue to do that in phase three. As far as data integrity attribution of efficacy, the extension phase that we discussed and the Rob expanded on a bit in a prior question is really going to be run very much the same way that the blinded phase is run so that in all of our studies, we watch people out of background therapy if folks are engaging in psychotherapy outside of the trial, that has to be stable and unchanging for a period of time before and through the trial.

Daniel Karlin: And we'll continue to enforce those same restrictions on outside treatment, other treatments, newly added psychotherapy through the entire extension phase. So while we do give folks the opportunity to get either dose for the first time as they started in a placebo arm or a control arm, the expectation is that the only treatment that they're receiving, the only newer change treatment that they're receiving in the only pharmacological treatment that they're receiving through the entire extension phase is M-120. Thank you, and I'm currently showing no further questions in the queue.

Unknown Executive: This does conclude today's conference call. Thank you all for joining and you may now disconnect.

Unknown Executive: [inaudible]

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