Q2 2025 Mind Medicine Mindmed Inc Earnings Call

Good afternoon, and welcome to the main <unk> second quarter 2025 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 of media section of my Meds website that mind that dot com and a recording will be available after the call.

I would now like to introduce Stephanie Pagan Chief Corporate Affairs Officer. Please.

Please go ahead.

Stephanie Fagan: Thank you, Operator, and good afternoon, everyone. Thank you for joining us today for a discussion of Mind Med's second quarter of 2025 business highlights and financial results. Leading the call today will be Rob Barrow, our Chief Executive Officer. He will be joined by Dr. Dan Karlin, our Chief Medical Officer, and Brandi Roberts, our Chief Financial Officer. After our prepared remarks, we will open the call for Q&A, and Matt Wiley, our Chief Commercial Officer, will also be available for questions. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call. During today's call, we will be making certain forward-looking statements, including without limitation statements about the potential safety, efficacy, and regulatory and clinical progress of our product candidates, our anticipated cash runway, and future expectations, plans, partnerships, and prospects.

Thank you operator, and good afternoon, everyone. Thank you for joining us today for a discussion of my mid second quarter of 2025 business highlights and financial results.

Leading the call today will be brought Barrow, our chief Executive Officer.

He will be joined by Dr. Dan Carlin, our Chief Medical Officer, and Brandi Roberts, our Chief Financial Officer.

After our prepared remarks, we will open the call for Q&A and Matt Wiley, Our Chief commercial officer will also be available for questions.

An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcements for this call.

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

Our anticipated cash runway and future expectations plans partnerships and prospects.

Stephanie Fagan: These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the FDC and the applicable Canadian securities regulators, 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 FDC and the applicable Canadian securities regulators or other significant events occurring outside of Mind Med's normal course of business. You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, July 31st, 2025.

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

These and other risk factors are described in our filings made with the SEC and the applicable Canadian Securities regulators, including our annual report on Form 10-K, and our Form 10-Q filed today.

Forward looking statements are based on the assumptions opinions and estimates of management at the date. The statements were made including the non occurrence of the risks and uncertainties that are described in our filings made with the SEC and the applicable Canadian securities regulators or other significant event occurring outside of nine months normal parts of the business.

You are cautioned not to place undue reliance on these forward looking statements, which are made as of today July 31 2025.

Stephanie Fagan: Mind Med disclaims any obligation to update such statements, even if management's views change, except as required by law. With that, let me turn the call over to Rob.

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

With that let me turn the call over to Rob.

Rob Barrow: Thank you, Stephanie, and thank you, everyone, for joining our call today. I'm very pleased with our overall performance and execution through the first half of the year. We are currently on track with enrollment with our three pivotal Phase III trials for our lead asset, MM120 ODT, which is being evaluated in patients with generalized anxiety disorder, or GAD, and major depressive disorder, or MDD, the two most common psychiatric disorders in the US. We took a strategic approach in selecting GAD and MDD as the initial indications for MM120 ODT, driven by the unmet medical need, clinical development feasibility, as well as the large commercial opportunity. Targeting both indications potentially provides us with the broadest label possible and enables us to reach a wider patient population.

Thank you Stephanie and thank you everyone for joining our call today.

I'm very pleased with our overall performance and execution through the first half of the year.

We are currently on track with enrollment in our three pivotal phase III trials for our lead asset and then 100000, ODT, which is being evaluated in patients with generalized anxiety disorder, or JD and major depressive disorder, where M. D D.

Two most common psychiatric disorders in the U S.

We took a strategic approach and selecting <unk> as the initial indications for it and then 100000 OTT driven by the unmet medical need clinical development feasibility as long as the large commercial opportunities.

Targeting both indications potentially provides us with the broadest label possible and enables us to reach a wider patient population.

Rob Barrow: In the US, more than 60 million people live with GAD or MDD, and notably, more than 50% of patients with GAD also suffer from MDD. This creates a meaningful opportunity to address both conditions with a single therapeutic approach, particularly considering the limitations of current treatments. We believe MM120 ODT has the potential to offer a differentiated, novel, best-in-class treatment option for these patient populations. MM120 was granted breakthrough therapy designation from the FDA based on the results of our Phase IIB trial in GAD, which showed an effect size of 0.81 in the 100-microgram cohort, more than double that of standard treatments. And as a reminder, a single dose of MM120 demonstrated strong clinical remission rates with 48% of participants in the 100-microgram cohort achieving remission at week 12.

The U S more than 60 million people listen to JD or NBD, notably more than 50% of patients with JD also suffer from M. D D.

This creates a meaningful opportunity to address both conditions with a single therapeutic approach, particularly considering the limitations of current treatments.

We believe <unk> has the potential to offer a differentiated novel best in class treatment option for these patient populations.

120 was granted breakthrough therapy designation from the FDA based on the results of our phase two b trial in G. A D, which showed an effect size of 0.81, and the 100 microgram cohort.

And double that of standard treatments.

A reminder, a single dose of <unk> 120 demonstrated strong kind of core emission rates with 48% of participants in the 100 microgram cohort achieving remission at week 12.

Rob Barrow: Our Phase III trials were thoughtfully designed to build on the strong foundation of these successful Phase IIB results, while also positioning MM120 ODT for real-world implementation. A key advantage of our approach is the efficient single-visit treatment model, which we believe aligns with existing reimbursement pathways and supports full session coverage. This approach not only streamlines delivery but also reduces the administrative burden on sites where MM120 ODT may be delivered. Commercial opportunity for MM120 ODT is significant, supported by strong provider interest. Our market research shows that 78% of interventional psychiatric providers believe the availability of psychedelic therapies will transform the treatment landscape for GAD and MDD. We remain focused on advancing our pivotal trials with urgency. Across all three studies, Voyage in Panorama and GAD, and Emerge in MDD, enrollment trends remain strong with continued enthusiasm and engagement from clinical sites.

Our phase III trials were thoughtfully designed to build on the strong foundation of the successful phase <unk> results. While also positioning in the 120 ODT for real World implementation.

A key advantage of our approach is the efficient single visit treatment model, which we believe aligns with existing reimbursement pathways and supports full session coverage.

This approach not only streamlined the delivery, but also reduces the administrative burden on sites, where and then more in 2000 ODT may be delivered.

Commercial opportunity for <unk> 120, ODT is significant.

Imported by strong provider interest.

Our market research shows that 78% of interventional psychiatric providers believe the availability of psychedelic therapies will transform the treatment landscape for <unk> and M. D D.

We remain focused on advancing our pivotal trials with urgency.

Across all three studies voyage in Panorama, and JD and emerging M. D. D enrollment trends remained strong with continued enthusiasm and engagements and clinical sites.

Rob Barrow: As our pivotal trials continue to progress, we are actively laying the groundwork for commercial readiness. This includes building our organization and making strategic hires to support both near-term execution and long-term growth, ensuring we're well-positioned to capitalize on the opportunity ahead. We are incredibly excited about the leadership we've been able to bring to the company, including most recently our new CFO, Brandi Roberts, who joined our team last month. Brandi brings over 25 years of life sciences financial leadership experience and is uniquely positioned to lead our financial strategy during this critical growth phase. Most recently, at Longboard Pharmaceuticals, she successfully led the company through its IPO and multiple financings, culminating in a $2.6 billion acquisition by Lundbeck. Her proven track record of scaling operations, supporting clinical development, and managing strategic investor relations brings tremendous value to our organization.

As our pivotal trials continue to progress we are actively laying the groundwork for commercial readiness.

This includes building our organization and making strategic hires to support both near term execution and long term growth, ensuring we're well positioned to capitalize on the opportunity ahead.

We are incredibly excited about the leadership, we have been able to bring to the company, including most recently, our new CFO Brandi Roberts, who joined our team last month.

Randy brings over 25 years of life Sciences financial leadership experience and is uniquely positioned to lead our financial strategy. During this critical growth stage.

Most recently at Longboard Pharmaceuticals, she successfully led the company through its IPO in multiple financings, culminating in a $2 $6 billion acquisition by Lundbeck.

Our proven track record of scaling operations supporting clinical development and managing strategic Investor Relations brings tremendous value to our organization.

Rob Barrow: On behalf of Mind Med, I'd like to welcome Brandi to our team. In summary, with three of our pivotal Phase III trials well underway and top-line readouts for each of these trials anticipated in 2026, we are anticipating a catalyst-rich year as we progress MM120. With that, I'll turn the call over to Dan for an update on our clinical programs.

On behalf of mind, Matt I'd like to welcome Brandi to our team.

In summary, with three of our pivotal phase III trial is well underway and topline readouts for each of these trials anticipated in 2026, we're anticipating a catalyst rich year as we progressing and 120.

With that I'll turn the call over to Dan for an update on our clinical programs.

Dan Karlin: Thank you, Rob. As you mentioned, we continue to be very encouraged with the enrollment trends we are seeing for our pivotal Phase III studies. Starting with our GAD studies, Voyage in Panorama, we remain on track and continue to expect top-line readouts from Voyage in the first half of 2026 and Panorama in the second half of 2029. As a reminder, each study consists of two parts: Part A, a 12-week randomized, double-blind, placebo-controlled parallel group period assessing the efficacy and safety of MM120 ODT versus placebo, and Part B, a 40-week extension period with opportunities for open-label treatment designed to provide important long-term data on the durability and response patterns with MM120 ODT.

Thank you Rob.

As you mentioned, we continued to be very encouraged with the enrollment trends, we're seeing for our pivotal phase III studies.

Starting with our <unk> studies voyage, Emma we remain on track and continue to expect top line readout from voyage in the first half of 2026 and Panorama in the second half of 2020.

As a reminder, each study consists of two parts part a 12 week randomized double blind placebo controlled parallel group period, assessing the efficacy and safety of <unk> 120, <unk> versus placebo.

And part B, a 40 week extension period with opportunities open label treatment designed to provide important long term data on the durability and response patterns with <unk> ODT.

Dan Karlin: In Voyage, we are targeting enrollment of approximately 200 participants who are being randomized one-to-one to receive MM120 ODT 100 micrograms or placebo, while in Panorama, we are targeting enrollment of approximately 250 participants who are being randomized two-to-one-to-two to receive MM120 ODT 100 micrograms, 50 micrograms or placebo. We modeled these Phase III studies after our successful Phase IIB study of MM120 and GAD. The primary outcome measure is the Hamilton Anxiety Scale, or HAMA, which was the outcome measure used in our Phase IIB study and was the outcome measure used for the approval of currently available GAD therapies. In our Phase III studies, the primary endpoint is the HAMA change from baseline to week 12. In our Phase IIB trial, we observed an almost eight-point HAMA improvement for MM120 over placebo at week 12.

In voyage, we're targeting enrollment of approximately 200 participants who are being randomized one to one to receive and then 120, ODT 100 micrograms or placebo.

While in Panorama, we are targeting enrollment of approximately 250 participants who are being randomized two to one to two to receive <unk> 120, ODT 100, micrograms, 50 micrograms or placebo.

We modeled these phase III studies after a successful phase <unk> study of <unk> 120, Mg a day.

The primary outcome measure is the Hamilton anxiety scale or <unk>, which was the outcome measure used in our phase <unk> study in <unk>.

The outcome measure used for the approval of currently available therapy.

In our phase III studies, the primary endpoint of the MAA changed from baseline to week 12.

In our phase two B trial, we observed genomics eight point improvement for <unk> 120 over placebo at week 12.

Dan Karlin: We designed the Phase III trials to have 90% power to detect a five-point improvement over placebo based on certain statistical assumptions. To ensure our actual statistical power is maintained, we are using an adaptive design in our GAD Phase III studies, which includes an interim blinded sample size reestimation that allows for increased enrollment of up to 50% in each trial if necessary. This approach helps to adjust for any unexpected variability in nuisance parameters, specifically dropout rates and pool variance of HAMA response, maintaining statistical power and enhancing the interpretability of our results if needed. Just like our GAD program, our MDD program will consist of two pivotal clinical studies.

We designed the phase III trials to have 90% powered to detect a five point improvement over placebo based on certain statistical assumptions.

To ensure our actual statistical power is maintained.

We're using an adaptive design in our <unk>.

Phase III studies, which includes an interim blinded sample size re estimation that allows for increased enrolment of up to 50% in each trial if necessary.

This approach helps to adjust for any unexpected variability a nuisance parameters, specifically dropout rate and pooled variant the PMA response, maintaining statistical power and enhance interpret ability of our results if needed.

Just like our <unk> program, our MVD program will consist of two pivotal clinical studies.

Dan Karlin: Our first study, Emerge, is comprised of two parts: Part A, a 12-week randomized, double-blind, placebo-controlled parallel group period assessing the efficacy and safety of a single dose of MM120 ODT versus placebo, and Part B, a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT subject to meeting eligibility requirements. In Emerge, we are targeting enrollment of at least 140 participants with a primary diagnosis of MDD randomized one-to-one to receive MM120 ODT 100 micrograms or placebo. The primary endpoint is the change from baseline in Montgomery Asperger Depression Rating Scale, or MADRS, at week six between the groups. We continue to anticipate top-line data from Emerge in the second half of 2026. In conclusion, our MM120 clinical development program is well-positioned for success. The FDA's breakthrough designation underscores the potential of this innovative therapy.

Our first study emerge is comprised of two parts part a a 12 week randomized double blind placebo controlled parallel group period, assessing the efficacy and safety of a single dose of <unk> 120, ODP versus placebo in part B, a 40 week extension period during which participants will be eligible.

The open label treatment with <unk> hundred 20, ODT subject to meeting eligibility requirements.

<unk>, we are targeting enrollment of at least 140 participants with a primary diagnosis of MTB randomized one to one to receive <unk> 120, ODT 100 micrograms or placebo.

The primary endpoint is the change from baseline in Montgomery as per depression rating scale or mattress at week six between the groups.

We continue to anticipate top line data from emerge in the second half of 2026.

In conclusion, our <unk> 120 clinical development program is well positioned for success.

The Fda's breakthrough designation underscores the potential of this innovative therapy.

Dan Karlin: We continue to have productive engagement with the FDA and appreciate the division's collaboration and responsiveness. Our Phase III studies are well aligned with FDA guidance. Further, these studies have been designed to demonstrate standalone drug effect. To increase our chance of clinical success, these trials closely mirror a positive Phase IIB study, which demonstrated substantial improvement over current therapies. With that, I'm happy to introduce Brandi to discuss our second quarter financial results. Brandi?

We continue to have productive engagement with FDA and appreciate the division collaboration and responsiveness.

Our phase III studies are well aligned with FDA guidance.

Further these studies have been designed to demonstrate standalone drug effect to increase our chances of clinical success. These trends closely mirror, our positive phase <unk> study, which demonstrated substantial improvement over current therapies.

With that I'm happy to introduce brandy to discuss our second quarter financial results.

Brandi Roberts: Thanks, Dan, and thanks, Rob, for the warm welcome and introduction. I'm thrilled to be here with you today, having joined Mind Med at such an exciting time. The opportunity to work with an experienced and passionate management team, especially with their deep drug development expertise, was a huge draw. Additionally, the chance to make a meaningful impact on mental health, an area with significant unmet need, really resonated with me. I'm excited to bring my experience to support our path to commercialization, which includes potential billion-dollar market opportunities. I will also be focused on enhancing our investor communications and leading our financing strategy to ensure we're well-capitalized to execute our priorities and create long-term shareholder value. As Rob and Dan mentioned, I'm also pleased that we are conducting our Phase III studies with remarkable efficiency, which is a testament to the thoughtful and strategic approach taken by our team.

Andy.

Thanks, Dan and thanks, Rob for the warm welcome and introduction I'm thrilled to be here with you today, having joined mind that at such an exciting time the opportunity to work with experienced and passionate management team, especially what their deep drug development expertise with a huge draw. Additionally, the chance to make a meaningful impact on mental health an area with significant unmet.

Need really resonated with me.

Cited to bring my experience to support our path to commercialization, which includes potential billion dollar market opportunities and will also be focused on enhancing our investor communication and leading our financing strategy to ensure we are well capitalized to execute our priorities and create long term shareholder value.

As Robin Dan mentioned I'm also pleased that we are conducting our phase III studies with remarkable efficiency, which is a testament to the thoughtful and strategic approach taken by our team.

Brandi Roberts: From a financial perspective, I want to underscore the significance of this efficiency. By optimizing our study designs and regulatory pathway, we are not only maximizing the potential for clinical success but also ensuring the thoughtful use of our resources. This approach enables us to allocate capital in a way that drives value for our shareholders. I'm confident that our strategic and fiscally responsible approach will enable us to deliver sustainable growth for years to come. Now to review our financial results for the quarter ended June 30, 2025. We ended the quarter with cash, cash equivalents, and investments totaling $237.9 million. Just a reminder that when looking at our balance sheet, this total comes from three line items: cash and cash equivalents, short-term investments, and long-term investments.

From a financial perspective, I want to underscore the significance of the sufficiency.

By optimizing our study designs and regulatory pathway, we are not only maximizing the potential for clinical success, but also ensuring the thoughtful use of our resources.

This approach enables us to allocate capital in a way that drives value for our shareholders I am confident that our strategic and fiscally responsible approach will enable us to deliver sustainable growth for years to come.

Now to review our financial results for the quarter ended June 32025.

We ended the quarter with cash cash equivalents and investments totaling $237 9 million. Just a reminder, that when looking at our balance sheet. This total comes from three line items cash and cash equivalents short term investments and long term investments.

Brandi Roberts: Based on our current operating plan and anticipated R&D milestones, we believe that our cash, cash equivalents, and investments as of June 30, 2025, will be sufficient to fund our operations into 2027 and at least 12 months beyond our first Phase III top-line data readout for MM120 ODT in GAD. Research and development expenses were $29.8 million for the second quarter of 2025, compared to $14.6 million for the second quarter of 2024, an increase of $15.2 million. The net increase was primarily related to increases of $14.5 million related to our MM120 ODT program, $1.5 million in internal personnel costs as a result of increased headcount, and $0.2 million related to preclinical activities, offset by a decrease of $1 million in MM402 program expenses based on the timing of studies.

Based on our current operating plan and anticipated R&D milestone, we believe that our cash cash equivalents and investments as of June 32025 will be sufficient to fund our operations into 2027 and at least 12 months beyond our first phase III topline data readout for <unk> 120, ODT and J D.

Research and development expenses were $29 $8 million for the second quarter of 2025 compared to $14 6 million for the second quarter of 2024, an increase of $15 2 million. The net increase was primarily related to increases of $14 $5 million related to our <unk> 'twenty ODT program one five.

And internal personnel costs as a result of increased head count and 0.2 million related to preclinical activities offset by a decrease of $1 million and 402 program expenses based on the timing of studies.

Brandi Roberts: We anticipate that our R&D expenses will continue to ramp up for the remainder of 2025 due to the costs associated with running three pivotal Phase III studies. General and administrative expenses were $11.1 million for the second quarter of 2025, compared to $9.8 million for the second quarter of 2024, an increase of $1.3 million. This increase was primarily related to personnel costs as a result of increased headcount to support corporate growth and prepare for commercialization. With that, I'll now turn it back over to Rob for our closing remarks.

We anticipate that our R&D expenses will continue to ramp up for the remainder of 2025 due to the costs associated with running three pivotal phase III studies.

General and administrative expenses were $11 1 million for the second quarter of 2025 compared to $9 8 million for the second quarter of 2024, an increase of one 3 million. This increase was primarily related to personnel costs. As a result of increased head count to support corporate growth and prepare for commercialization.

With that I'll now turn it back over to Rob for closing remarks.

Rob Barrow: Thanks, Brandi, and it's great to have you on board. In closing, 2025 is a critical year of execution, and I'm extremely proud of how our team is delivering. Our three ongoing pivotal trials remain on track with strong clinical site engagement, underscoring both the significant unmet need and the transformative potential of MM120 ODT. We've built a high-caliber leadership team with the expertise to execute our strategy and drive long-term shareholder value. With 2026 expected to be a catalyst-rich year, we remain confident in our ability to deliver on our mission of bringing a differentiated, best-in-class, novel treatment option to the millions of patients who desperately need it. Thank you for joining us on the call today. The team and I are now happy to answer your questions.

Thanks, Brandy and it's great to have you on board.

In closing 2025, the critical year of execution and I am extremely proud of how our team is delivering.

Our three ongoing pivotal trials remain on track with strong clinical site engagement underscoring both the significant unmet need and the transformative potential of IMMU 120 ODT.

We have built a high caliber leadership team and the expertise to execute our strategy and drive long term shareholder value.

With 2026 is expected to be a catalyst rich year, we remain confident in our ability to deliver on our mission of bringing a differentiated best in class novel treatment option to the millions of patients who desperately need it.

Thank you for joining us on the call today.

You and I are now happy to answer your questions.

Operator: Thank you. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Mark Goodman with LeRig. The floor is yours.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.

Our first question comes from the line of Marc Goodman with leap.

Lyric.

The floor is yours.

Michael Okunewitch: Hey, how are you guys? Rob, there's been a lot of data that's come out by other psychedelic companies. I was just curious your thoughts on what you've seen so far and how you think about that just relative to your programs.

Hey, how are you guys.

There's been a lot of data that's come out by other psychedelic companies I was just curious your thoughts on.

What you've seen so far and how you think about.

That just relative to your programs.

Rob Barrow: Yeah, thanks so much for the question, Mark. Yeah, it's an exciting time for the field, and certainly as we get into 2026, an especially exciting time when we have the three pivotal readouts from GAD and MDD next year. One of the things we've been really excited about with our data from Phase II, and obviously it would be great to see replicate as we progress, is the magnitude and the significance of the change that we've been able to demonstrate that is also durable for many months. And that's something we haven't yet seen from any other drug in the class or any other program so far.

Yes.

Yes, thanks, so much for the question Mark.

Yes, it's an exciting time for the field and certainly as we get into 2026, and especially same time, we have the three pivotal readouts from JD and MTV next year.

What are the things we've been really excited about with our data from phase II and obviously.

It'd be great to see replicate as we progressed as the magnitude and the significance of the change that we've been able to demonstrate that is also durable for many months and thats something we havent yet seen from any other.

Doug in the glass or any other program so far and so we've been I think as we've engaged with physicians.

Rob Barrow: And so we've been, I think, as we've engaged with physicians and payers and everyone, we've been particularly excited by the reception of those data and by the promise of a drug that has such a significant impact and such a durable impact on patients and one that we, again, hope to continue to show strong evidence of efficacy and safety in the pivotal study. So certainly, again, excited for the field, excited for our programs, especially as we get into the Phase III readouts next year.

And payers and everyone. We've been particularly excited about the reception of those data and by the promise of a drug that has such a significant.

Impact in such a durable impact on patients and one that we again hope to continue to show strong evidence of efficacy and safety in the pivotal study so.

So again excited for the field excited for our programs, especially as we get into the phase II Readouts next year.

Operator: Thank you for your question. One moment, please. Our next question comes from Pete Stavanopoulos from Cantor. The floor is yours.

Thank you for your question.

Okay.

One moment please.

Okay.

Our next question comes from Pete.

Stephanopoulos, Fujian <unk> the floor is yours.

Matt Wiley: Yeah, hi, Rob and team. Congratulations on the progress. Brandi, nice to hear you, and congratulations on your new position. You know, for the Voyager and Panorama studies, you know, can you just discuss the powering assumptions and the assumed dropout rate or study discontinuation rates? And you know, for the Phase IIB, I believe there was a 25% dropout rate. You know, can you expand on steps you're taking to drive better retention and how much of that is attributed to the OLE design or higher probability of active treatment?

Yeah, Hi, Robin team.

Congratulations on the progress Brian Nice to hear you and congratulations on your position.

Sure.

Sure.

The Voyager and Panorama studies can you just discuss the powering assumptions.

You assume dropout rate.

We're starting to see discontinuation.

Discontinuation rates and for the Phase II B I believe there was a 25%.

Dropout rates can you expand on steps were taken to drive better retention and how much of that is attributed to the OLED design or a higher probability of active treatment.

Rob Barrow: Yeah, thanks so much for the question, Pete. I'll cover the first part of that and then turn it over to Dan. The powering assumptions are consistent across both Voyage and Panorama, which is we assumed 90% power to detect a five-point difference between those groups. And it's important to note that while a power analysis is incredibly important, we also look at the minimum clinical difference that would need to be observed to get a statistically positive outcome. And that, by nature of the maths, is almost always lower than the powering assumptions. And so while we're powered for a five-point delta at 90%, and that assumes a 10-unit standard deviation and a 15% dropout rate, we certainly would anticipate that we wouldn't necessarily need to see a five-point difference between the groups to get a statistically positive outcome.

Yes, thanks, so much for the question Pete.

I'll cover the first part of that and then turn it over to Dan the powering assumptions are.

Our consistent across both voyage and Panorama, which is we assume 90% power.

In fact, a five point difference between those groups.

Important to note that.

Our power analysis is incredibly important.

Also look at the minimum kind of a difference that would need to be observed together statistically positive outcome in that by nature of the Max is almost always lower than the powering assumptions and so.

While we're powered for a five point delta at 90% and that assumes a 10 unit standard deviation in that 15% dropout rate.

Yes.

We certainly would anticipate that we wouldn't necessarily need to see a five point difference between the groups ticket are statistically positive outcome.

Rob Barrow: And I'll turn it over to Dan to talk about patient retention and how we're thinking about that in Phase III.

It over to Dan to talk about patient retention and how we're thinking about that in phase III.

Dan Karlin: Yeah, thanks, Rob, and thanks, Pete. I think you actually identified exactly the features of the study that are going to control that dropout rate. And obviously, having more folks in an active treatment arm yields less dropout. But you identified, I think, what we look at as the absolute key feature, particularly for folks who aren't feeling better after their first blinded dose, is that knowing if they hang in there for that full 12-week observation period, that we will provide the opportunity for open-label treatment is a real encouragement for people to stick around for the entire double-blind period. So we're optimistic about that dropout rate and optimistic about the ability to provide those open-label treatments during the extension phase.

Thanks, Rob and thanks Pete.

I think you actually identified exactly great features of the study that are going to control that dropout rate and obviously, having more folks into an active treatment arm.

Yields less drop out, but you had it for I think what we look at is the absolute key feature.

Particularly for folks who arent feeling better after their first blinded dose is that knowing its a hang in there for that full 12 week observation period that we will.

The opportunity for open label treatment as a real encouragement for people to stick around for the entire double blind period. So.

We are optimistic about about that dropout rate and optimistic about the ability to provide those does open label treatments during the extension phase.

Matt Wiley: Thank you. And one more question, if you don't mind. I guess, assuming positive Phase III data and MM120 is approved, what do you expect from real-world use and commercialization? And what I'm sort of asking is, how are the Phase IIIs and the OLE designed to sort of generate real-world treatment patterns?

Thank you and then one more question if you don't mind.

I guess, assuming positive phase III data.

And then 120 as proved.

What do you expect from real World usage commercialization and what Im sort of asking is how would the phase threes and the OLED designed to sort of generate real world treatment patterns.

Rob Barrow: Yeah, I'll turn that one over to Dan as well.

Yeah, I'll turn it over to Dan as well.

Dan Karlin: Yeah, that's another really exciting part of the extension phase is that, as we've said before, the extension phase gets us the ability to watch long-term, so over that full year of observation and even beyond, what the effect of the double-blind treatment is. For folks who do progress to the extension phase and then are able to get open-label treatment, we intentionally set a limit of four treatments per year, thinking that that is more than folks would need because we don't want to right-limit those data. So we want to actually get at, exactly as you say, real-world treatment patterns. So given the availability of those open-label treatments with a threshold that's below the threshold for enrollment, the threshold set for retreatment being right at the threshold for mild to medium illness.

Yeah.

Another really exciting part of the extension phase.

As we've said before the extension phase gets us the ability to watch long terms over that full year of observation.

And beyond.

The effect of the double blind treatment is.

For folks who do progress to the extension phase and then are able to get.

Enable treatment, we intentionally set a limit of four treatments per year thinking that that is more than 10 folks would need because we don't want a rate limit those data. So we want to actually get at exactly as you say real world treatment patterns. So given the availability of this open label.

With a threshold that's below the threshold for enrollment threshold set for <unk>.

<unk>.

The thresholds for mild to medium illness.

Dan Karlin: And what we think we'll see in the extension phase is very much what we expect to see in the real world. So that given that threshold for treatment, given the fact that it's open-label, given the fact that we have the clinical trial sites closely engaged with patients, we think that we'll be able to establish the range of treatment patterns that are to be anticipated in real-world treatment and be able to describe those as we come out of that study and the results of the extension phase.

And what we think we will see in the extension phase.

Much of what we expect to see in the real world. So that given that threshold for treatment given the fact that it's open label given the fact that we have that.

The clinical trial sites closely engaged with patients we think that we'll be able to establish the range of treatment patterns that are to be anticipated in real world treatment would be able to describe those.

As we come out of that study and the results of the extension phase.

Matt Wiley: All right, thank you. Helpful, and congratulations once again.

Yes.

Alright, Thank you helpful and congratulations once again.

Operator: Thank you for your question. Our next question comes from Brian Abrams with RBC Capital Markets. The floor is yours.

Thank you for your question.

Okay.

Our next question comes from Brian Abrahams with RBC capital markets. The floor is yours.

Brian Abrahams: Hi there. Good afternoon. Thanks for taking my questions. Congrats on the continued progress and congrats to Brandi on the role. Two questions from me, I guess. First, just kind of thinking about the enrollment trends for the Voyage study. It sounds like those are going quite well. I'm just sort of wondering if you're kind of at the point where more than 50% of the trial has enrolled and an interim analysis would be taken to determine whether you'd expand sample sizes. And then secondly, I'm curious sort of the degree of commercial preparatory work that you might start to do at this point and what your sense is from just operationally the study, the execution of the studies, what the key areas that you're going to need to focus on or want to focus on first in the launch with respect to site education and awareness. Thanks.

Hi, there good afternoon. Thanks for taking my questions. Congrats on the continued progress and congrats to Randy on the role.

Two questions from me I guess first.

Just kind of thinking about the enrollment trends for the voyage study if it sounds like those are going quite well and just sort of wondering if you're kind of at the point, where more than 50% of the trial has enrolled and an interim analysis would be taken to determine whether it would expand sample sizes and then secondly.

I'm curious sort of the degree of commercial preparatory work that you might start to do at this point.

Your sense is from just operationally the steady execution of the studies.

The key areas that youre going to need to focus on our Waterford focus on first.

Within the launch with respect to site education and awareness.

Rob Barrow: Yeah, thanks so much, Brian. To your first question, we have not given exact numerical updates on enrollment. As a reminder to everyone, the interim analysis would be conducted after about half of the patients have completed 12 weeks of the study, but we've yet to give a precise update on numbers. And certainly, we're excited to get through that milestone and get through to data. In terms of the second question, I'll turn it over to Matt Wiley as well for our Chief Commercial Officer to answer.

Okay. Thanks, so much Brian.

So to your first question.

We have not given.

Exact numerical updates on enrollment.

As a reminder to everyone. The interim analysis will be conducted after about half the patients have completed 12 weeks of the study but.

We've yet to give precise update on numbers.

Certainly we're excited to get through that milestone.

Get through.

The data.

In terms of the second question I'll turn it over to <unk>.

Matt Wiley as well for our Chief commercial officer to answer.

Matt Wiley: Yeah, thanks for the question, Brian. And so you know as we have spent the last several months working through a number of key strategic elements of the plan, first and foremost, the market access. We want to understand the different pathways to reimbursement. We're anchoring our market access strategy into practice economics. We want to make sure that clinicians not only have access to the drug, but it's not a loss-making opportunity for them. So we've spent a lot of time examining the industry progress, the different pathways that are used in interventional psychiatry. We've also spent quite a bit of time breaking down the targeting methodology for GAD. We want to ensure that we're targeting those facilities out of the gate that have the highest volume of GAD patients, those that are probably most appropriate for MM120 right at launch. So we've gone through that process.

Yes, thanks for the question, Brian and so as we have spent the last several months working through a number of key strategic elements of the plan first.

First and foremost that market access we want to understand the different pathways to reimbursement.

We're anchoring our market access strategy.

In practice economics, we want to make sure that.

Clinicians not only have access to the drug, but it's not a loss making opportunity for them. So we've spent a lot of time examining.

The industry progress.

The the different pathways that are used in the interventional psychiatry. We've also spent quite a bit of time.

Breaking down the targeting methodology for <unk>, we want to ensure that we're targeting those facilities out of the gate.

That have the highest volume of ghd patients those that are probably most appropriate for am 120, right at launch. So we've gone through that process. We've built out a targeting apparatus that we think is pretty tight.

Matt Wiley: We've built out a targeting apparatus that we think is pretty tight. And so now we know where our patients are and where the clinicians who manage them are as well. So that's where we've been focused. And over the last month or two, we've really zeroed in on our product positioning, and we're working on our messaging platforms and market conditioning efforts as well. So as we move through our process over the next several months, we'll have more to update on our pre-market conditioning activities and also more on our market entry strategy.

And so now we know where our patients are where they are clinicians who manage the MLR as well.

So that's where we've been focused.

And.

Over the last month or two we've really zeroed in on our product positioning and we're working on our messaging platforms in market conditioning efforts as well so as we as we move through our process over the next several months, we'll have more to update on our pre pre market conditioning activities and also more on our.

Our market entry strategy.

Brian Abrahams: That makes a lot of sense. Thanks so much.

That makes a lot of sense. Thanks, so much.

Alright.

Matt Wiley: All right.

Operator: Thank you for your questions. Our next question comes from Arabella at AC Weinreich. The floor is yours. Arabella, the floor is yours. We're just going to continue on. One moment, please. Our next question comes from Jay Olson of Oppenheimer. The floor is yours.

Thank you for your questions.

Yes.

Okay.

Our next question comes from Arabella.

At H C. Wainwright the floor is yours.

<unk> the floor is yours.

We're just going to continue on.

One moment please.

Our next question comes from Jay Olson of Oppenheimer. The floor is yours.

Speaker 9: Oh, hey, guys. Congrats on the progress and thanks for taking the questions. Can you just talk about your expectations for the durability of efficacy beyond 12 weeks, and when do you expect us to seize that longer-term efficacy data?

Oh, Hey, guys. Congrats on the progress and thanks for taking the questions can you just talk about your expectations for the durability of efficacy beyond 12 weeks and when do you.

This too to see that longer term efficacy data.

Rob Barrow: Yeah, thanks so much for the question, Jay. You know, in Phase II and the highest quality data we have to go on, we didn't continue observing patients formally in a structured manner beyond 12 weeks. And so we certainly also didn't see a trend where there was a loss of separation or a trend back towards baseline for patients who received 100 micrograms. And so if those trends were to replicate, they would certainly suggest that durability could last beyond a 12-week period. We do have some evidence from prior studies from collaborators who have conducted prior studies to suggest that in anxiety disorders, the effects can be quite long-lasting. And in the event, and not uniformly distributed either, of course, where sometimes a second administration can have an even further prolonged extension of that durability.

Yes, thanks, so much for the question Jay.

In phase two and the highest quality data we have to go on.

Didn't continue observing patients, formerly an instruction manner beyond 12 weeks in so.

We certainly also didn't see a trend where there is a <unk>.

Loss of separation of our trend back towards baseline for patients who received 100 micrograms and so.

If those trends were to replicate they would certainly suggest that durability could last beyond 12 weeks period.

We do have some some evidence from prior studies from collaborators who have conducted prior studies to suggest that.

In anxiety disorders, the effects can be quite long lasting and in the event.

Not uniformly distributed either of course.

Sometimes a second administration can have an even further prolonged extension of that durability. So.

Rob Barrow: So it'd be premature to make assumptions about exactly where those data would fall out, but we're certainly very eager to get to those data as we progress in the studies. We haven't given enough specific guidance around when those data would be made available, but again, we're certainly very, very excited to get those data and share those as they do become available.

Sure to make assumptions about exactly where those data would fallout, but we're certainly very eager to get to those data.

Progress in the studies.

Given that specific guidance around when those data will be made available but.

Again.

Very excited to get those data and share those as they do become available.

Speaker 9: Okay, great. Thank you. And if maybe I could ask one follow-up. Assuming that your Phase III study results do confirm the initial observations from Phase II, what would you expect the dosing interval to be in terms of number of doses per year in a real-world setting?

Okay, great. Thank you and if maybe I could ask one follow up assuming that your phase III study results to confirm the initial observations from phase two what would you expect the dosing interval to be in terms of.

<unk> of doses per year in a real world setting.

Dan Karlin: Yeah, I'll turn that one over to Dan. Yeah, it's a great question, Jay. And obviously, we're working in a somewhat speculative space there. But as Rob pointed out, we did not see loss of efficacy in folks who had a strong response to a single dose in Phase II, and we expect that will be the case for many folks in the Phase III as well, and of course, in the real world. So what we anticipate for the use of this drug is not so much predictive intervals where we can pre-specify for any individual, though you're likely to need to take this every six months or every year, but we expect that different people will have different response patterns.

Okay.

Turn that one over to Dan.

Yes, it's a great question, Jay and obviously, we were working and then it's somewhat speculative space there, but as Rob pointed out we did not see loss of efficacy and folks who had a strong response to a single dose in phase two and we expect that will be the case for many folks.

In the phase III as well and of course in the real world. So what we anticipate for the use of this drug is not so much.

Predictive intervals, where we can pre specify for any individual though youre likely to need to take this every six months or every year, but we expect that different people will have will have different response patterns. In those response patterns will range from on the best possible response somebody who takes a dose and it goes into remission as the <unk>.

Dan Karlin: And those response patterns will range from the best possible response, someone who takes a dose and goes into remission and has a sustained period of remission such that if they ever were to need a subsequent dose, we could almost think of that as a new development of the disorder, all the way through to, on the other end, folks who do need some sort of regular re-dosing. Now, given that we were seeing efficacy out to 12 weeks in Phase II and that they're very likely proceeded longer, that interval could be six months. It could be a year. It could be three months in some cases.

<unk> period of emissions such that if they ever were to need to subsequent dose. We can almost think of that as a new development of the disorder. All the way through to on the other end folks who do need some sort of regular re dosing now given that we were seeing efficacy out to 12 weeks in phase II.

We proceeded longer.

Interval could be six months it could be year it could be three months in some cases, but but unlike.

Dan Karlin: But unlike daily drugs today or unlike other drugs that have a requirement for a pre-specified interval because they lose efficacy either when off drug or shortly after taking drug, we think real-world treatment patterns will be quite a bit more variable with our drug.

Daily drugs today are unlike other drugs that have a requirement for pre specified interval because they lose efficacy either when off drug or shortly after taking drug we think real world treatment patterns will be will be quite a bit more variable.

With our drug.

Matt Wiley: Great. Super helpful. Thanks for taking the questions.

Great Super helpful. Thanks for taking my questions.

Yes.

Operator: Thank you for your question. Our next question comes from Elias Kejoras from Canaccord. The floor is yours.

Thank you for your question.

Our next question comes from Elias <unk> from Canaccord the floor is yours.

Speaker 9: Hi, this is Elias for Sumont. Thank you for taking the question. I was just thinking about with your discussions with the FDA, can you provide any color on what maybe the design of the second Phase III MDD study would look like? Are you going to be required to use the 50-microgram dose as you had to do in your GAD studies as well?

Hi, This is our liaison for Sue Mark. Thank you for taking the question.

I was just thinking about.

With your discussions with the FDA have you can you provide any color on what maybe the design of the second phase III <unk> study would look like.

Are you going to be required to use the 15 microgram dose as you had to do.

And your.

<unk> studies as well.

Okay.

Rob Barrow: Yeah, thanks for the question. We haven't yet disclosed the design of that study, and we've continued to have a lot of progress with both the GAD and MDD programs. Obviously, there's been a historical discussion around expectancy and functional unblinding and different approaches to try to mitigate that in these studies. We always refer back to the reality that every drug in psychiatry deals with functional unblinding. It just so happens that this is based on the qualitative nature, kind of the first time that programs are widely being asked to go an extra mile to try to control for and look at this. But we certainly see some utility in inclusion of a dose such as that, which is, of course, why we included it in our second GAD study.

Yes, thanks for the question.

We haven't yet disclosed the design of that study and we've continued to have a lot of progress with both the <unk> and <unk> programs.

Obviously theres been a historical discussion around expecting to see in functional blinding and different approaches to try to mitigate that in these studies.

We always refer back to the reality that every drug in psychiatry deals are functional and binding just so happens that this is based on the qualitative nature kind of the first time that programs are widely being asked to go.

An extra mile to try to control for and look at this but.

We certainly see some utility and inclusion of the dose such as that is of course why we.

Included in our second JV study.

Rob Barrow: But when the time comes and we're in a position where we're able to share the study design, we'll certainly also want to be sharing and talking through rationale for any of the choices we've made in terms of how the second MDD study is designed and how we're executing it.

But when the time comes our positioning we're able to share. The study design was certainly off.

We want to be sharing in talking through rationale for inventory. So as we've made in terms of how the second <unk> study.

Design and about how we're executing.

Matt Wiley: Awesome. Thank you.

Awesome. Thank you.

Operator: Thank you for your question. Our next question comes from Patrick Turicchio from AC Weinreich. The floor is yours.

Thank you for your question.

Our next question comes from Patrick <unk> from HC Wainwright the floor is yours.

Speaker 9: Hello, everyone. This is Luigi and for Patrick. Thank you so much for taking our questions and welcome, Brandi, to the team. I would like to ask a little bit about the strategic collaborations that you've already established with interventional psychiatry treatment centers. You mentioned that you have grown your partnerships and that your payer discussions and reimbursement strategy align along with the deployments of your treatments in this network of centers. Can you give any updates with respect to the services, specifically monitoring time and time in the clinic? Thank you so much.

Hello, everyone and the reason for Patrick. Thank you so much for taking my questions and welcome Brandi to the team.

I would like to ask a little bit about the strategic collaborations that you've already established with interventional psychiatry with treatment centers.

You mentioned.

That.

Do you have.

Ground.

The partnerships and the Europe.

The discussions and reimbursement strategy.

As the lines along with the deployment of.

Yes.

Your treatments in these in this network.

All centers.

Can you give any updates with respect to the services.

Specifically monagene time ends.

<unk> time in the clinic. Thank you so much.

Rob Barrow: Yes, thanks for the question. One of the elements of our Phase III program is to, as we approach development generally, is to really try to have a pre-specified and a thoughtful approach to understand all the dynamics of treatment, whether it be real-world-like re-dosing in the extension phase of the study or the dynamics of a single administration of the drug. And so we are monitoring that and have a structured way of doing so that we've talked through and presented with FDA in prior discussions. And so defining that timeline and what it is for individual patients and on average and the various summary statistics you can come up with that could be suggestive of how long patients need to stay in a clinic is something we're very focused on and certainly thinking about as we analyze the data from the Phase III study.

Yes, thanks for the question.

One of the elements of our phase III program is too.

As we approach development generally is to really try to have a.

Pre specified in a thoughtful approach to understand all the dynamics of treatment whether it be.

Real.

Real world like re dosing in the extension phase of the study or the dynamics of a single administration of the drug and so we are monitoring that and have a.

Structured way of doing so that we have.

Talk through and presented with FDA in prior discussions and so defining that timeline and what it is for individual patients and on average in the various summary statistics you can come up with that could be suggestive of how long patients stay on the clinic.

It's something we're very focused on and so they are thinking about as we analyze the data from the phase III study so.

Rob Barrow: So as we engage in that and have additional clarity we can offer, we can certainly be in a position to share that at some point in the future.

As we engage in that and have it.

Clarity and can offer we can sort of get a position yet to share that at some point in future.

Speaker 9: And reimbursement, any updates on how it would fit the current Medicare plans?

And reimbursement any updates on how it would fit in the current.

Medicare plans.

Rob Barrow: Yeah, it's premature to talk specifically about reimbursement. We have continued to have strong engagement with payers and feel confident in our approach going forward, but certainly premature today to say anything precise around the dollars for reimbursement.

Yes, it's premature to talk specifically about reimbursement and we have continue to have strong engagement with with payers and.

And.

So feel confident in our approach going forward, but certainly premature today to say anything precise around the $1 for reimbursement.

Speaker 9: Great. Thank you and congratulations on your progress.

Great. Thank you and congratulations thanks very much.

Operator: Thank you for your question. Our next question comes from Chris Chen from Baird. The floor is yours.

Thank you for your question.

Our next question comes from Chris Chen from Baird. The floor is yours.

Rob Barrow: Thanks for taking my question. I just had one on enrollment. I know you've previously talked about the synergies between the GAD trials and Emerge such that if a patient is screened for GAD but it turns out they're diagnosed with MDD, they can roll into the MDD trial. Can you just confirm that? And if so, can you comment on whether some of the sites are seeing this happening? Yeah, thanks so much for the question, Chris. That certainly was our intent in designing the studies and running them in parallel and making sure that we have as much efficiency in the conduct across both of the indications. And as the studies have progressed, we've seen that play out exactly as we had hoped, where we're getting nice retention.

Thanks for taking my question.

I just had one on enrollment I know you can you can.

So you talked about the synergies between.

The gas trials and emerge such that if a patient is screened.

For Gan, but it turns out they're diagnosed with MTBE they can roll into the AMD trial can.

Can you just confirm that and if so can you comment on whether some of the sites are seeing this happening.

Yes, thanks for the question Chris.

So that was our intent and designing the study and running them in parallel and making sure that we have as much efficiency in the conduct across both of the indications and as these studies progress we've seen that play out exactly as we had hoped.

We're getting.

Nice retention and for patients who do have.

Rob Barrow: And for patients who do have a depressive episode, we have an easy path to move them into a depression program if that ultimately emerges in the screening process. Great. And then I did have one more follow-up. Just in terms of the treatment visit itself, can you kind of add a little more color? Is there a healthcare provider in the room the whole time during that dosing? And if so, what guardrails are in place to avoid kind of crossing that line between providing psychotherapy versus just assisting the patient? Thank you. Yeah, thanks. I'll turn it over to Dan to answer.

Depressive episode, we'd have an easy pass to move them into a depression program, if that ultimately emerges and screening process.

Great and then I did have one more follow up.

Just in terms of the treatment visit itself.

Can you kind of add a little more color. It is there a health care provider in the room.

Whole time during that dosing and if so.

What guardrails are in place.

To avoid kind of crossing that line between providing psychotherapy versus just assisting in the patient.

Thank you.

Yeah, Thanks, I'll turn it over to Dan to answer yes.

Dan Karlin: Yeah, thanks, Chris. It's a great question. And there is a provider in the room. There's also always another person watching the conduct in the room. And we're very explicit on what folks are allowed to do in that room and where their focus needs to be. And their focus is on assistance. And for the most part, not engaging with the participant. Most of the time, participants are in the room. They're engaging with their own internal process, and the monitor is doing just that monitoring. So through that process of training and monitoring of the conduct in the room, we stay on the side of monitoring and away from psychotherapy.

Yes, Thanks, Chris.

Great question and there is provider in the room is also always an another person watching the conduct in the room.

And were very explicit on what folks are allowed to do in that room, and where their focus needs to be and their focus is on assistance in.

For the most part not engaging with the participant most of the temporary sprints or in the room, they're engaging with their own internal process and the monitor is doing just that monitoring so.

Through that process of training and.

And monitoring of the conduct in the room.

<unk>.

Stay on the <unk>.

Decided monitoring and away from psychotherapy.

Yes.

Rob Barrow: Great. Thank you. And congrats again on the progress.

Great. Thank you and congrats again on the progress.

Operator: Thank you for your question. Our next question comes from Rudy Lee from Cherryton. The floor is yours.

Thank you for your question.

Our next question comes from Rudy Li from Chery, then the floor is yours.

Speaker 9: Hi, thanks for taking my question. Congrats on the progress and welcome to the team, Brandi. So it's good to hear that the timeline for the 12-week primary readout was confirmed. Could you remind us what additional data are required by the FDA and what will be the rate-limiting stats for filing the NDA for GAD? Thanks.

Hi, Thanks for taking my question Congrats on the progress and welcome to the team ready.

So it's good to hear that the timeline for the 12 week primary readout was confirmed.

Could you remind us.

Additional data required by the FDA and what will be the rate limiting steps for filing the NDA for J D.

Rob Barrow: Yeah, thanks so much for the question, Rudy. Certainly, the studies have been designed such that the primary endpoints at 12 weeks and the double-blind, placebo-controlled parallel group portion of the study, part A of both Voyage and Panorama, are studies we expect to have completed before we'd potentially be moving forward with an NDA. So all eyes are on that top-line readout, which would drive the path forward from there.

Yes, thanks, so much for the question Rudy.

Certainly.

The studies have been designed such that the primary endpoints at 12 weeks in the double blind placebo controlled parallel.

Group.

Firstly on the study part of questions voyage in Panorama, our studies, we expect to have completed.

Before we had to potentially move forward with an NDA. So.

We're all eyes are on that topic.

Top line readout, which would.

In fact drive the path forward from there.

Speaker 9: Cool. I do have a quick follow-up question. You mentioned that you're exploring additional programs, including potentially external collaborations to expand the pipelines. Can you provide additional color on your overall strategy? Like what kind of product or indication that you look at?

Cool.

A quick follow up question.

And that youre exploring additional programs, including potentially.

Colonel collaborations to expand the pipelines is can you provide additional color on your strategy, what kind of product or indication that you are looking at.

Rob Barrow: Yeah, it's a great question. We're incredibly excited about all that we have in our pipeline, with three pivotal studies ongoing. Of course, a lot of focus gets put on those studies. And certainly, MM120 is an asset. It's one of the best-known drugs in the entire class and one so far that seems to have provided some really standout activity in our Phase IIB program. But there is certainly much more that our team is working on and that we're capable of bringing forward into the future. And as we look at the landscape, we feel incredibly confident in the organization we've built and the team's ability to execute and the scope of what we think we can accomplish long-term to really drive meaningful change for patients and meaningful shareholder value is something that we are always focused on. So certainly, stay tuned because we're excited about 120.

Yes, it's a great question.

Incredibly excited about all that we have in our pipeline with three pivotal studies ongoing of course, a lot of focus gets.

Put on those studies and certainly in <unk> 'twenty as an asset it's one of the best known drugs in the entire class and one so far it seems to have provided some some really.

Standout activity in our phase II program, but there is certainly much more that our team is.

Working on and that we're capable of bringing forward into the future.

As you look at the landscape and we feel incredibly confident in the organization, we've built and the team's ability to execute and the scope of what we think we can accomplish.

Long term to really drive meaningful change for patients and meaningful shareholder value is something that we're always focused on so.

Certainly stay tuned because.

Rob Barrow: We're excited about everything else we're doing as well and excited to share that as time progresses.

We're excited about 120, we're excited about everything else, we're doing as well and I'm excited to share that as time progresses.

Speaker 9: Cool. Very helpful. Thank you.

Very helpful. Thank you.

Operator: Thank you for that question. Our next question comes from Michael Okenvlich from Maxim Group. The floor is yours.

Thank you for that question.

Our next question comes from Michael <unk> from Maxim Group the floor is yours.

Michael Okunewitch: Hey, guys. Thanks so much for taking my questions today. I guess just to kick things off, I'd like to see if you could talk a little bit about your IP position and strategy and how important that this might be in the context of any discussions with potential partners or pharma. And I bring this up now because I'm sure you saw the report from a few days ago regarding Gilgamesh and AbbVie.

Hey, guys. Thanks, so much for taking my questions today.

I guess just to kick things off I'd like to see if you could talk a little bit about your.

Your IP position and strategy and how important that this might be in the context of any discussions with potential partners or pharma and I bring this up now because I'm sure you saw the report from a few days ago regarding Gilgamesh and Abbvie.

Rob Barrow: Yeah, thanks for the question, Michael. Yeah, we're really confident in our IP strategy and with the patents we've been granted and continue to file. And the team we've been working with for many years to advance our approach and make sure that we're filing applications on real meaningful innovations and delivering a product that is targeted to be optimized for patients and that is also something we can protect. And that continues to play out and we continue to progress with our IP strategy and filing. So we feel very comfortable with that position and are also comfortable that anyone looking at it would feel similarly.

Yes, thanks for the question Michael.

We're really confident in our IP strategy and with the type of patents have been granted and continue to file in.

The team we've been working with for many years too.

Advance our approach and make sure that we're filing applications on real meaningful innovation.

Yes.

Delivering a product that is.

<unk> targeted to be optimized for patients and that is also something we can protecting that.

That continues to play out and we continue to progress with our IP strategy and filing.

We feel very comfortable with that position.

Also comfortable that anyone looking at where feel so suddenly.

Michael Okunewitch: All right, thank you. And then, well, we have seen a lot of enthusiasm behind psychedelics come out of FDA. Even earlier today, Compass mentioned that it's exploring opportunities for an accelerated pathway. Is this something that could make sense for Mind Med, or is it a bit of a different situation with your two Phase III readouts being so close together and generalized anxiety versus treatment-resistant depression?

Alright. Thank you and then we have seen a lot of enthusiasm behind psychedelics come out of SBA, even earlier today Compass mentioned that it is exploring.

Opportunities for an accelerated pathway is this something that could make sense for mine med or is it a bit of a different situation with your two phase III readouts being so close together and generalized anxiety versus treatment resistant depression.

Rob Barrow: Well, certainly, we have breakthrough therapy designation, which already offers some avenues for, of course, greater engagement, but also opportunities for acceleration. So it's always something we're looking to do is be as efficient and execute and deliver on time and then expedite the path from there. So we're certainly exploring all avenues and all options to do that. The timing of the readouts, we also feel it's important to provide robust evidence and a comprehensive program that would stand up to any degree of scrutiny at any point in time under any review timelines. And so we're eager to get to our readouts next year. And having both pivotal readouts in the same calendar year gives us an opportunity to be in the strongest possible position with the GAD program.

Well certainly we have breakthrough therapy designation, which are already offers some avenues for of course greater engagement, but also akshay for acceleration. So it's.

Always something we're looking to do is be as efficient.

Execute and deliver on time and in expedite the path from there so.

We're certainly exploring all avenues and all options to do that.

The timing of the Readouts.

We also tell us it's important to provide.

Robust evidence in a comprehensive program that would stand up to any degree of scrutiny at any point in time under any review timelines and so.

We're eager to get to a readouts next year and having.

Yes.

Pivotal readouts and the same calendar year gives us an opportunity to be the strongest possible position with J D program.

Michael Okunewitch: All right, thank you very much. And congrats on all the progress you're making.

Alright, Thank you very much and congrats on all the progress Youre, making.

Operator: Thank you. Thank you for your question. Our last question comes from Sumont Kokami from Canaccord. The floor is yours.

Thank you. Thank you for your question.

Our last question comes from <unk> Kulkarni from Canaccord the floor is yours.

Matt Wiley: Good afternoon. Thanks for taking my question. I'd like to welcome Brandi with a question. How are you thinking about the appropriateness of the financial resources that are available given so many pivotal trials are running right now at Mind Med?

Good afternoon. Thanks for taking my question I'd like to welcome back to you with your question.

How are you thinking about.

The financial resources available given so many.

The trials are running right now.

Brandi Roberts: Yeah, thanks so much, Sumont. It's great to have joined the team. This is such an exciting time for the company. I mean, I think when you look at that, you know I'm really impressed with how we've put our Phase IIIs together so that there are efficiencies built in there, like we've just talked about, with being able to use sites that are enrolling in our GAD and our MDD studies. So I think that that's really helpful. I also think we've been really prudent as we've grown, and we will continue to do that and really analyzing when we need to add resources and making sure that those are all responsible in terms of the timelines that we're adding people and adding activities to it. So I think that's been really our focus.

Yeah. Thanks, so much demand it's great to have joined the team. This is such an exciting time for the company.

When you look at that I'm really impressed with how we've put our phase threes together. So that there are efficiencies built in there like we've just talked about.

With being able to use sites that are enrolling in our <unk> and our MTV studies. So I think that that's really helpful. I also think we've been really prudent as we've grown and we will continue to do that and really analyzing why do we need to add resources and making sure that those are all.

Responsible in terms of the timelines that we're adding people and adding activities to it.

So I think that's been really our focus I.

Brandi Roberts: I will say that we really do like to make sure that we have flexibility as well. This quarter, we did amend our debt agreement with K-2, and so that provides us with additional flexibility if we need to. And there are things that we think would enhance our programs. But as we stated in the call, we feel very comfortable with our cash position and guidance getting into 2027 and 12 months post our top-line GAD readout. And so I feel like we're in a good position to execute and are looking forward to next year.

I will say that.

We really do like to make sure that we have flexibility as well this quarter. We did amend our debt agreement with Q2, and so that provides us with additional flexibility if we need to and there are things that we think would enhance our program, but as I as we said on the call. We felt very comfortable with our cash position and guidance getting into 2027 and 12 months.

Post our topline <unk> readout.

Readout and so felt like we're in a good position to execute and I'm looking forward to next year.

Yes.

Matt Wiley: I'll squeeze a commercial question in. Nowadays, investors seem to be kind of jumping to a conclusion on a perceived fact that less time in the clinic is potentially always better when it comes to psychedelic therapeutics. How are you thinking about your MM120 in the context of that kind of thinking?

I'll squeeze a commercial question.

Nowadays investors seem to be kind.

Jumping to a conclusion on that.

On a positive.

The fact that less payment the clinic is essentially always better when it comes to secondary therapeutics. How are you thinking about your <unk> in the context of that kind of thinking.

Rob Barrow: Yeah, thanks, Sumont. I'll take this one. We remain incredibly convicted about both the activity and the dynamics of MM120 in relation to both approved products and the potential there, but also in the broader field of drugs with similar mechanisms of action. I think it tends to be an easy assumption to fall back on what is already being done. But like any real meaningful innovation, those precedents and assumptions can only serve anyone so far. And so we, again, remain in all of our discussions and all of our planning. And as we think about the landscape, we're incredibly encouraged by those discussions and by the dynamics of MM120. I think there's some other dynamics as we progress and share more about commercial strategy that can also highlight some dynamics. But certainly, there's the Spravato model is one that exists.

Yes. Thanks.

I'll take this one.

How are you.

We remain incredibly convicted about.

Both the activity and the dynamics of other than 120.

In relation to both approved products and the potential there, but also in the broader field of drugs with similar mechanisms of action I think.

<unk> tends to be easy.

Easy assumption to fall back on what is already being done, but like any real meaningful innovation does.

Precedence in assumptions.

Only.

Can only serve anyone so far and so.

We again remain in all of our discussions and all of our planning.

As we think about the landscape, we're incredibly encouraged by those discussions about the dynamics of it and then 120 I think there's some other dynamics as we progress and share more of our commercial strategy.

Also highlight some dynamics, but certainly there is this provider model is one that exists.

Rob Barrow: It emerged in response to the availability of a treatment, which in Spravato, that is, which we're now, again, if Phase II data are something we can replicate, we feel really confident about being able to stand out in the field in terms of the kind of magnitude and durability of response that we've seen so far. So as we think about every dynamic from practice economics, as Matt alluded to earlier, to patient and provider preferences and the desire to make sure that if a patient is going to have such a durable effect, that their providers have the opportunity to navigate that with them and really support them throughout their overall care journey, not just the administration of our product.

Emerged in response to the availability of a treatment, which.

<unk> provided that is which we're now.

Again, if phase II data are.

And we can replicate that we felt were really talking about being able to stand out in the field in terms of the kind of magnitude and durability of response that we've seen so far so as we think about every dynamic prices economics, as Matt alluded to earlier to patient and provider preferences and the desire to make sure.

That if a patient is going to have such a durable effect that they are providers have the opportunity to.

Navigate that with them and really support.

Then throughout their overall care journey, not just did administration of our product.

Rob Barrow: Again, we feel really, really good about the dynamics of our program and our product and are eager to show the world how that plays out over the long term.

Again, we feel really really good about the dynamics of our program and our product and.

Alright, eager to show the world how that plays out over long term.

Matt Wiley: That's very helpful. Thanks.

That's very helpful. Thanks.

Operator: Thank you for that question. There are no further questions, so this does conclude the question and answer session. At this time, I'd like to thank you for your participation in today's conference. This does conclude the program, and you may now disconnect.

Thank you for that question.

There are no further questions. So this does conclude the question and answer session.

At this time I would like to thank you for your participation in today's conference. This does conclude the program and you may now disconnect.

Okay.

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Okay.

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