Q3 2023 Mind Medicine (MindMed) Inc Earnings Call
Okay.
[music].
Speaker 1: The.
Speaker 2: Good afternoon and welcome to the Mind Medicine third quarter 2023 financial results and corporate update conference call. Currently, all participants are in listen only mode. This call is being webcast live on the investors and media section of Mind Med's website at mindmed.co and a recording will be available after the call. After the presentation, there'll be an opportunity to ask questions.
Good afternoon, and welcome to the mine Medicine third quarter 2023 financial results and corporate update conference call. Currently all participants are in listen only mode. This call is being webcast live on the investors and media section of mine Mets website at mine Mad Duck call and a recording will be available.
After the call after the presentation there'll be an opportunity to ask questions to join the question queue. You May Press Star then one on your telephone keypad should you need assistance during the conference call you May signal, an operator by pressing star M zero for opening remarks, I would like to introduce Rob barrels CEO of mine.
Speaker 2: To join the question queue, you may press star, then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. For opening remarks, I would like to introduce Rob Barrow, CEO of MindMed. Please, go ahead.
Please go ahead.
Speaker 3: Thank you and good afternoon everyone. Welcome to our third quarter 2023 Financial Results and Corporate Update conference call.
Thank you and good afternoon, everyone.
Welcome to our third quarter 2023 financial results and corporate update conference call.
Speaker 3: The press release reporting our financial results is available in the investors and media section of our website. And our quarterly report on Form 10Q, the quarter ended September 30, 2023, will be filed today with the Securities and Exchange Commission.
The press release reporting our financial results is available at the investors and media section of our website.
Our quarterly report on Form 10-Q, the quarter ended September 32023 will be filed today with the Securities Exchange Commission.
Speaker 3: 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 in our product candidates, financial projections, and our future expectations, plans, partnerships, and prospects.
During today's call, we will be making certain forward looking statements.
Without limitation statements about the potential safety efficacy and regulatory and clinical progress of our product candidates financial projections and our.
Future expectations plans partnership and prospects.
Speaker 3: These statements are subject to various risks, such as changes in market conditions and difficulties associated with research and development regulatory approval processes that are described in the filings made with the SEC, including the most recent annual report on Form 10-K and quarterly report on Form 10-Q .
These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development regulatory approval processes.
And they are described in our filings made with the SEC.
The most recent annual report on Form 10-K.
The report on Form 10-Q.
Speaker 3: Four looking statements are based on the assumptions, opinions, and estimates of management of the date the statements are made, including the non-accurrence of the risks and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of my med-stormal course of business.
Forward looking statements are based on the assumption that the.
The management and the date the statements were made including the non recurrence of the risks and uncertainties that are described in our filings made with the SEC or other significant event occurring outside of my bad storm and of course the business.
Speaker 3: Your caution not to place undue reliance on these four of the key statements, which are made as of today, November 2nd, 2023.
You are cautioned not to place undue reliance on these forward looking statements.
As of today November 2nd 2023.
Speaker 3: My med disclaims any obligation to update such statements, even if management views change, except is required by law.
<unk> disclaims any obligation to update such statements, even if management is change except as required by law.
Speaker 3: Joining me on today's call are Sean Greenway, our Chief Financial Officer, Dr. Daniel Carlin, our Chief Medical Officer, and Dr. Francois Lelensaw, our Chief Commercial Officer.
Joining me on today's call are John Greenway, Our Chief Financial Officer, Dr. Daniel Carlin, our Chief Medical Officer and Dr. Francois Lebel.
Our chief commercial officer.
Speaker 3: We're excited to be providing this financial and business update during this important period for MindMed.
We're excited to be providing this financial and business update during this important period for my bad.
Speaker 3: Over the past year, we have made significant progress on our first site, R&D pipeline, which is positioning us for a series of important milestones in the coming quarters. In particular, the top line data readouts are phase 2D trial of NM120 and generalized anxiety disorder or GAD.
Over the past year, we have made significant progress on our diversified R&D pipeline, which has positioned us for a series of important milestones in the coming quarters in particular, the topline data readout from our phase two B trial, and then 120 in generalized anxiety disorder or J D.
Sure.
Speaker 3: Believe our team continues to demonstrate best in class execution and we're going to cash runway that fund our organization into 2026. If certain milestones are achieved, then unlock additional capital. We feel that we are well positioned to continue accelerating across our R&D pipeline.
I believe our team continues to demonstrate best in class execution, and with a cash runway to fund our organization into 2026.
Milestones are achieved and unlock additional capital.
So that we are well positioned to continue accelerating across our R&D pipeline.
Speaker 3: Our progress comes at a critical time with an urgent need for better treatment to address the ongoing epidemic, the brain health disorders. A situation that has grown significantly worse over the past several years.
Our progress comes at a critical time with an urgent need for better treatments to address the ongoing epidemic with brain health disorders.
It has grown significantly worse over the past several years.
Speaker 3: In our lead indication, GAD, for example, a recent mental health prevalence study that was prepared for the substance abuse and mental health services administration. From the 10% of US adults report having symptoms consistent with a GAD diagnosis, making it the second most common mental health disorder among adults, is 18 to 65 years old.
Our lead indication G. A D. For example, a recent mental health prevalent study it was prepared for the substance abuse and mental health services administration.
Per cent of U S. Adults report, having symptoms consistent with the JD diagnosis.
Looking at the second most common mental health disorder, among adults, aged 18 to 65 years old.
Speaker 3: In comparison to historical studies, what a prevalence of GAD. This condition appears to have tripled in the last two decades alone. We're going to estimated prevalence of about 10% today.
In comparison to historical studies, there's probably lots of JD. This.
This condition appears to have tripled in the last two decades alone with an estimated prevalence of about 10% today.
Speaker 3: This growth and prevalence and focus on anxiety disorders has unfortunately not been matched by innovative treatments. With the treatment landscape continuing to be dominated by serotonin reuptake inhibitors, vendidae azopines, and in more limited cases anti-psychotic.
This growth in prevalence and focus on anxiety disorders has unfortunately, not been matched by innovative.
The treatment landscape continuing to be dominated by serotonin reuptake inhibitors.
Yeah.
And more limited cases.
Got it.
Speaker 3: In fact, they last approved original marking application for the treatment of GAD with obtained for some baltas in 2004.
In fact, the last approved original marketing application for the treatment of <unk>.
Paying for Cymbalta in 2004.
Speaker 3: Speaking to address the growing issues, our R&D pipeline is focused on two-league candidates, MM120, a Lyser-Jai D-Tart rate, an MM402, or R&DMA.
He came to address these growing issues. Our R&D pipeline is focused on chewy candidates and then one 'twenty leiser Jai Detar trade and then four O to O R. M D N a.
Speaker 3: Additionally, through a broad collaboration with researchers at University Hospital, Bago and Futsulent, we are exploring potential of several assets, particularly the expanded development pipeline, and our lead programs continue to progress.
Additionally, through a broad collaboration with researchers at University Hospital Basel, Switzerland.
We're exploring the potential of several asset since they expand our development pipeline and our lead programs continue to progress.
Speaker 3: Across these development programs, we are utilizing both a session-based delivery pair of dimes, such as with the MN120 and GAD, which the product candidate is administered under ongoing healthcare supervision.
Across these development programs, we're utilizing both Easter Sunday is still very good guy.
And then 120 and J D.
I wish the product candidate is administered under ongoing health care supervision.
Speaker 3: and the standard outpatient drug delivery pair of guys, such as with MN120, as we explore the current non-lucinogenic administration model, and with MN402 in autism spectrum disorder, which we envision being administered on a daily at home basis.
And the standard outpatient drug delivery paradigm.
And then 120 did you explore the current non whose synergetic administration model.
And then flow to and autism spectrum disorder.
Asian being administered on a daily at home basis.
Speaker 3: Our MM120 program of GAD is an extraordinary enthusiasm and execution over the past year.
And then one 'twenty program, and J D and extraordinary enthusiasm and execution over the past year.
Speaker 3: In August 2022, we dose the first patient in our face to the dose optimization study at the minimum on 20 for GAID.
In August 2022, we dosed the first patient in our phase <unk> dose optimization study at Midnight March 'twenty for J D.
Speaker 3: We completed enrollment in the study in just over one year and are now on the cusp of reporting top-line data through four weeks of follow-up later this quarter.
We completed enrollment in the study and just over one year now and the cost of a reporting topline data through four weeks of follow up later this quarter.
Speaker 3: J.D. is a common debilitating brain health disorder that is underserved by currently available for ARP.
J D as a common debilitating brain health disorders.
Understood by currently available therapies.
Speaker 3: These therapies include serotonin reuptych inhibitors, and the day has been, in more limited cases, you sphere on an anticecotics, all of which present inadequate efficacy profiles of the many patients, and often involve side effects that are intolerable and dose or duration limiting.
These therapies include serotonin reuptake inhibitors, and if they hadn't been a more limited cases misfire on an anti psychotics all of which present inadequate efficacy profile for many patients and often involves side effects that are intolerable and dose or duration limiting.
Speaker 3: Against this backdrop, we seek to develop in the 120 the best in class therapy, the novel-mechanical interaction. And we should acute for single administration leads to weeks or even months of clinical benefits.
Against this backdrop, we seek to develop and then 120 <unk> best in class therapy, and novel mechanism of action, which in acute or single administration needs to weeks or even months of clinical benefit.
Speaker 3: In addition to the session-based delivery of M1-20 and GAD, you're investigating the direct neuropharmacologic lack of M1-120. It was a serotonin agonist and innovative treatment registered.
In addition to the session based delivery it and then 120 and J D. You're investigating the direct.
Pharmacological actually I've been 120 <unk>.
Serotonin agonists and innovative treatment regimen.
Speaker 3: One such exploratory approach is a Phase 2 proof of contact study of N120 in ADHD.
One such exploratory approach is a phase II proof of concept study it and then 120 in ADHD.
Speaker 3: This study is being conducted in collaboration with University Hospital Basel and Footsearn and Master of University and the Netherlands and designed to evaluate the therapeutic utility of repeat low doses of NN120 and adult patients with ADHD.
This study is being conducted in collaboration with the University Hospital Basel sharp in Maastricht University in the law.
Designed to evaluate the therapeutic utility of repeat low doses.
120 adult patients with ADHD.
Speaker 3: Today, no SAE's have been reported, suggesting the real world potential of this treatment regimen, as well as been in trading on a ability to deliver NM120 with innovative dose and frequency combinations.
To date, no Esa use have been reported with dusting of real world potential of this treatment regimen.
Well as demonstrating our ability to deliver it and then 120 with innovative dose and frequency combination.
Speaker 3: As you announce in October enrollment in this concept study is complete. With a total of 53 participants administered either 20 micrograms of M1-120 or placebo twice weekly, for up to six weeks.
As we announced in October enrollment in this the concept study is complete with a total of 53 administered either 20, microgram and 120 placebo twice weekly for up to six weeks.
Speaker 3: The primary endpoint in the study is a mean change from baseline and ADHD symptoms as assessed by the Adult ADHD Investigator Symptom Rating Scale, or AISRS, after six weeks of administration.
The primary endpoint. The study is the mean change from baseline in ADHD symptom.
As assessed by the adult ADHD investigators symptom rating scale or a I S. R. L.
After six weeks of administration.
Speaker 3: We anticipate reporting top-line results from this study by the end of the first quarter of 2024.
We anticipate reporting top line results from this study.
End of the first quarter of 'twenty 'twenty four.
Speaker 3: Our second lead program is MM402, which is the RNA tumor of MDMA.
Our second lien program, and then 402, which is the R. Enantiomer of M D N a.
Speaker 3: We believe NM402 holds promise for its potential pro-social effects and favorable tolerability profile versus racemic MVMA.
We believe and then part two holds promise for its potential pro social effects and favorable tolerability profile versus racemic N V M M.
Speaker 3: The focus of our MM402 program is to develop a regularly administered product that treats the core symptoms of Autism Spectrum Disorder, or ASD, in particular, social communication disorder.
The focus of ours, and then 402 program developing regularly administered product.
Of course, sometimes lots of inspection disorder, where a S D.
Particular, social communication difficult.
Speaker 3: Remarkably, despite the significant and increasing prevalence of ASD, there are currently no approved therapies specifically targeted at its core symptoms.
Remarkably despite the significant increase your truckload capacity. There currently no approved therapies, specifically targeted at its core symptoms.
Speaker 3: MDMA, often referred to as a pathogen, is a synthetic molecule known to enhance feelings of connectedness and compassion.
M DMA, often referred to as in a pathogen and this synthetic molecule no one do enhance feelings of connectedness compassion.
Speaker 3: The RNA tumor of MDMA in particular is believed to boost serotonin and other neurotransmitter levels in the brain, leading to increased sociability and interpersonal emotional connection.
The RNA and DNA in particular is believed to boost their return and other neurotransmitter levels in the brain leading to increased their stability enter personal emotional connection.
Speaker 3: Preclinical studies of R-MDMA, including those we reported earlier this year, have shown acute prosocial and pathogenic effects, while its reduced dopaminergic activity suggests it might exhibit fewer stimulant, neurotoxic, hyperthermic, and abuse-related effects compared to racemic MDMA or BS enantiomer.
Preclinical studies of our M D N a.
As we reported earlier this year.
It's really cute pro social and pathogenic effects, while it's reduced dopaminergic activity suggests it might exhibit fewer stimulus neurotoxic hypothermic and abuse related effects compared to racemic them DMA or be asked to Nashville.
Speaker 3: With robust pre-conical evidence supporting our approach, we are excited to launch the Phase I clinical trial and then for acute, which we expect to initiate in this quarter.
With robust preclinical evidence supporting our approach we're excited to launch the phase one clinical trial and then part two we expect to initiate later this quarter.
Speaker 3: The trial aims to assess MMFOR2's tolerability, pharmacokinetics, and pharmacodynamics. And we are actively exploring all possibilities to generate early indications of efficacy during development.
The trial aims to assess and then part two is tolerability pharmacokinetics and pharmacodynamics.
We actively exploring all possibilities to generate early indications of vaccine development.
Speaker 3: And currently, we are collaborating with University Hospital Basel to conduct a comparative phase one pharmacokinetic and pharmacodynamics study of R, S, and racemic MDMA.
So currently we are collaborating with University hospital Boswell conduct comparative phase, one pharmacokinetic and Pharmacodynamic study of R. S. Racemic M D.
Speaker 3: This study was designed to enroll healthy volunteers and to evaluate the tolerability, pharmacokinetics, and acute subjective, physiological, and endocrine effects in the 3-molecule.
This study was designed to enroll healthy volunteers and to evaluate the tolerability pharmacokinetics acute subjective physiological endocrine effectually three molecule.
Speaker 3: Successful completion of this study is expected to expedite our understanding of MN402's pharmacological profile as we progress into later stages of clinical development.
Successful completion of this study is expected to expedite our understanding is unfortunates pharmacological profile.
Progress into later stage clinical development.
Speaker 3: We've been informed by the UHB investigators that they anticipate completing enrollment of the study by the fourth quarter of this year, and anticipate that data will be presented in the first half of 2024.
We've been informed by the U H B investigators they anticipate completing enrollment of the study about the fourth quarter of this year.
Just stay at the data we presented in the first half of 'twenty four.
Speaker 3: For the upcoming readout for our Phase 2b study of MN-120 and GAD, we'll now take a moment to dive deeper into the context and approach to this important program.
With the upcoming readout for our phase III study of <unk>, and then 'twenty and J D. Well now take a moment to dive deeper into the context and approach this important program.
Speaker 3: Glycergide, or LSD, is the most extensively studied drug in the psychedelic drug class, with over 10,000 individuals administered the molecule in clinical trials alone.
Spicer diet or LST at the most extensively studied drug and if I could ask drug class with over 10000 individuals administered the molecule in clinical trial bar.
Speaker 3: This includes hundreds of patients suffering from anxiety, depression, and other neurotic disorders across dozens of studies, which is concerning.
This includes hundreds of patients suffering from anxiety depression, and other neurotic disorders across dozens of studies.
But just consistently Shannon.
Speaker 3: potential of life should die to deliver rapid and durable benefits with a magnitude of clinical activity that is double or triple that of the standard of care.
Full of life their drive to deliver rapid and durable benefit with <unk>.
I'm going to kind of activity.
Is double or triple that of the standard of care.
Speaker 3: Our phase 2b study of MN-120 and GAD was designed to characterize dose-response relationship of MN-120 and GAD across a wide range of doses.
Our phase <unk> study and then one 'twenty NGA D was designed to characterize dose response relationship and then 120 <unk> across a wide range of doses.
Speaker 3: Our approach utilizes an industry-standard study design with entry criteria and clinical endpoints that we believe are replicable in typical studies.
Our approach utilizing industry standard study design with entry criteria and clinical endpoints that we believe are replicable.
It'll studies.
Speaker 3: As announced in September , we completed enrollment and dosing in our Phase 2b trial with top-line results to be reported later this quarter.
As announced in September we completed enrollment and dosing in our phase two b trial with top line results to be reported later this quarter.
Speaker 3: A total of 198 patients were randomized and administered a single dose of either 25, 50, 100, or 200 micrograms of MN120 or a placebo, and followed for up to 12.
A total of 198 patients were randomized administered as a single dose of either 25, 5100, or 200, micrograms and 128 or a placebo.
And followed for up to 12 weeks.
Speaker 3: The primary objective of the study is to determine the dose-response relationship of MN120 across the four active dose arms as measured by the change in Hamilton Anxiety Rating Scale, or HAMAE, at four weeks post-dose.
The primary objective of this study to determine the dose response relationship and then one 'twenty across the four active dose arm as measured by the change in Hamilton anxiety rating scale or M. A X four weeks post dosing.
Speaker 3: This is the first large, modern study to test the stand-alone pharmacological effects of a psychedelic drug candidate.
This is the first large modern study to test the Standalone pharmacological effect at least I could I like drug candidate.
Speaker 3: that is in the absence of any psychotherapeutic intervention, the importance of which was emphasized in the FDA draft guidance on clinical trials with psychedelic drugs earlier this summer.
That is in the absence of any type of therapeutic intervention.
The importance of which emphasize and the FDA draft guidance on clinical trials, if I could now like drugs earlier this summer.
Speaker 3: We believe that it will also help provide key insights to inform an optimal phase three program, the design of which we anticipate discussing with FDA at an end of phase two meeting after the conclusion of our phase two B study.
We believe it will also help provide key insights to inform an optimal phase III program. The design of which we anticipate discussing with the FDA and into phase two meeting after the conclusion of our phase <unk> study.
Speaker 3: We believe the design and conduct of our Phase 2b study is perhaps the most closely aligned with the FDA guidance that has ever been conducted, and as such, we are well-positioned to seamlessly transition into typical studies of MN120 and GAD, subject to positive results for our Phase 2b study rate of this quarter.
We believe the design and conduct of our phase <unk> study is perhaps the most closely aligned with the SBA guidance that's ever been conducted.
And as such we are well positioned to seamlessly transition into pivotal studies, and then 120th J D subject to positive results for our phase <unk> study later this quarter.
Speaker 3: From a statistical standpoint, our Phase 2b study utilized an approach called the Multiple Comparison Procedure Modeling, or MCPMOD approach, a sophisticated statistical technique developed by Novartis in 2004, which we believe is especially well-equipped to demonstrate dose response and optimize dose selection.
From a statistical standpoint, our phase <unk> study utilized an approach called the multiple comparison procedure modeling or MTP not approach.
Sophisticated statistical techniques developed by Novartis in 2004.
We believe it is especially well equipped.
To demonstrate dose response and optimize their selection.
Speaker 3: The MCP model analysis involves a two-part statistical test, which first assesses whether any dose response exists, then assesses which of the pre-specified dose response curves, as illustrated on the right, most closely fits the data.
The MCP Mod analysis involved with two parts statistical path.
First assesses whether any dose response exist.
Which was a prespecified dose response curves as illustrated on the right most closely with data.
Speaker 3: This statistical methodology has received qualification opinions from both FDA and EMA, with both agencies commenting on the statistical efficiency and effectiveness of the approach due to the utilization of all available data that is captured across the study arm and informs the statistical conclusion.
The statistical methodology has received qualification opinions from both FDA and DMA with both agencies, commenting on the statistical efficiency and effectiveness to be approach due to the utilization of all available data that was captured across the study arm.
And then forms the statistical conclusion.
Speaker 3: As we approach top line data for MM120 and GAD at the bridge corridor, it is important to contextualize the current treatment landscape and associated magnitudes of clinical response.
As we approached topline data for it and then 120 and Jay maybe this quarter.
And important to contextualize the current treatment landscape.
The magnitude of clinical response.
Speaker 3: current standard of care for GAD is dominated by serotonin reuptake inhibitors.
The current standard of care for J D is dominated by serotonin reuptake inhibitors benzodiazepine.
Speaker 3: which account for approximately 80% of the market by dollar value here in the U.S.
Account for approximately 80% of the market by dollar value here in the U S.
Speaker 3: Even so, results from peer-reviewed publications highlight the relatively modest clinical response to currently available therapies, exemplified by a standardized effect size of under 0.4 for the leading GAD therapies.
Even though results from peer reviewed publications highlight a relatively modest kind of corresponds to currently available therapies.
Simplified standardized effect size of under 0.4, leaving J D therapy.
Speaker 3: As a reminder, the standardized effect size can be contextualized as a mean placebo adjusted change divided by the standard deviation of that change. And it's a useful measure of overall treatment effect to study.
As a reminder, the standardized effect size can be conceptualized as a mean placebo adjusted change divided by the standard deviation of that change is a useful measure overall treatment effect.
Speaker 3: A commonly cited review of GAD treatments that analyzed clinical data from 21 double-blind placebo-controlled studies found an average effect size of 0.36 for SRIs, 0.38 for benzodiazepines, and only 0.17 for abuse-prone.
Economy sided review of G O D treatment that analyze clinical data from 'twenty, one double blind placebo controlled study.
Average effect size of 0.36 S alright.
Alright, Joe 0.38 benzodiazepine.
Only 0.17th abuse Brown.
Okay.
Speaker 3: These results and other published literature suggest that an effect size of 0.36 or better is viewed by the medical community as a clinically meaningful outcome, which is consistent with the feedback we have received from numerous key opinion leaders and practitioners in psychiatry.
These results and other published literature, suggesting an effect size of 0.36 or better is skewed by the medical community and a clinically meaningful outcome, which is consistent with the feedback we have received from numerous key opinion leaders and practitioners in psychiatry.
Speaker 3: In addition to our conviction that MN-120 may represent a best-in-class therapy for the treatment of GAD.
In addition to our conviction that and then 120 may represent a best in class therapy for the treatment of J E T.
Speaker 3: We believe that we will be able to achieve a scalable, widely-adoptable treatment model with attractive delivery dynamics in comparison to recent innovative products in psychiatry, such as Janssen's Spravato or intranasal eskenamine, which is currently approved to treat treatment-resistant depression.
We believe that we will be able to achieve a scalable widely adopt for treating bottle with attractive delivery dynamics in comparison to recent innovative products in psychiatry, such as young people to provide out or intranasal, that's kind of.
It is currently approved to treat treatment resistant depression each.
Speaker 3: Each Spravato administration session requires two hours of monitoring. Spravato is indicated for administration twice weekly during a four-week induction phase for a total of up to eight treatment sessions or 16 hours of monitoring in the first month alone.
Can you just provide a administration's section requires two hours of monitoring.
Provider, who has indicated for administration twice weekly during a four week induction phase for a total of up to eight treatment sessions or 16 hours of monitoring in the first months long.
Speaker 3: And for patients that are fully compliant for a year of treatment with Spavato, they would be getting between 34 and 56 treatment sessions for a total of up to 102 hours of time in the clinic per year.
And for patients that are fully compliant for a year of treatment with either it would be getting between 34 and 56th Street concessions for a total of up to 102 hours of time in the clinic per year.
Speaker 3: Despite what seems like a significant physical and provider infrastructure required to deliver Spravato, there are now over 3,000 Spravato treatment centers nationwide, and both the cost of Spravato and provider time for patient monitoring are being covered by major insurers.
Despite what seems like a significant physical and provider infrastructure required to deliver survival. There are now over 3000 bravado treatment centers nationwide and both of course with Nevada and provider time for patient monitoring are being covered by major insurers.
Speaker 3: While we believe the profile of NM120 could open up its scalability even further, the recent success in the adoption of Spravato presents a promising proof case for the widespread adoption of NM120.
Well, we believe the profile and then 120 could open up the scalability even further.
Success in the adoption to provider presents a promising proof case, the widespread adoption and then 'twenty.
Speaker 3: Through the first nine months of the year, Johnson reported a lot of sales of approximately $483 million, up 89% compared to the same period in the prior year.
Through the first nine months of the year.
Reported sales of approximately $483 million up 89% compared to the same period in the prior year.
Speaker 3: We continue to make significant progress in both our R&D programs in advancing our commercial strategy market readiness and are excited to share more updates on both fronts in the month ahead. With that, I will turn the call over to our CFO , Sean Greenway, to discuss our financial results. Sean, thanks Rob.
We continue to make significant progress in both our R&D programs and advancing our commercial strategy and market readiness and are excited to share more updates on both fronts in the months ahead.
With that I'll turn the call over to our CFO Shang Greenway to discuss our financial results John.
Thanks, Rob.
And thank you all for joining us today.
Speaker 3: We now turn to the company's financial results for the quarter ended September 30th, 2023.
I'll turn to the company's financial results for the quarter ended September 32003.
Speaker 3: As of September 30, 2023, MindMed had cash and cash equivalents totaling $117.7 million, compared to $142.1 million as of December 31, 2022.
As of September 30th 2023 mine Mad had cash and cash equivalents totaling $117 $7 million compared to $142 $1 million December 31 2022.
Speaker 3: The company believes its available cash and cash equivalents, as well as its committed credit facility, are expected to fund operations into 2026, if certain milestones are achieved that unlock official capital.
The company believes its.
Cash and cash equivalents.
Well, it's committed credit facility are expected to fund operations into 2026.
Certain milestones are achieved unlocking capital.
Speaker 3: For the nine-month period ended September 30, 2023, the company's net cash used in operating activities was $43.8 million compared to $37.3 million for the same period in 2022.
For the nine months period ended September 32023, the company's net cash used in operating activities was $43 8 million compared to $37 $3 million for the same periods in 2022.
Speaker 3: research and development expenses were $13.2 million for the quarter ended September 30, 2023, compared to $7.8 million for the same period in 2022, an increase of $5.4 million.
Research and development expenses for <unk>.
$13 $2 million for the quarter ended September 32023, compared to $7 $8 million for the same period in 2022, an increase of $5 $4 million.
Speaker 3: The increase was primarily due to increases of $6.4 million in expenses related to clinical research and product development for the MM120 GAD study, and $0.4 million in internal personnel costs as a result of increasing research and development capabilities, which were partially offset by a decrease of $0.4 million in expenses related to our M402 program.
The increase was primarily due to increases of $6 $4 million in expenses related to clinical research and product development for the <unk> 20 <unk> study.
How do you look at $4 million and internal personnel costs as a result of an increase in resource himself capabilities, which were partially offset by a decrease of zero point $4 million in expenses related to our employee two program.
Speaker 3: a decrease of $0.2 million related to our AM1 temp program, a decrease of $0.5 million and in pre-plendid activities, and $0.2 million in connection with various external RG collaboration.
A decrease of zero point $2 million related to our <unk> program.
Zero point $5 million and preclinical activities.
Zero point $2 million in connection with various external R&D collaborations.
Speaker 3: General administrative expenses were 8.4 million dollars for the quarter ended September 30th, 2023 compared to 9.2 million dollars in the same period. 30 thousand, thank you. It increased at 0.8 million dollars.
General and administrative expenses were $8 4 million for the quarter ended September 32023, compared to $9 $2 million from the same period for 2022, a decrease of zero point $8 million.
Speaker 3: Decrease was primarily related to issuance costs related to the company's 2022 U.S. dollar financing warrants that were issued as part of the company's public equity offering, which closed on September 30th, 2022.
Decrease was primarily related to issuance costs related to the company's 2022 of your lifestyle expert answered warrants that were issued as part of the company's public equity offering which closed on September 32022.
Speaker 3: I will now turn the call back to Rob who will provide some closing comments.
I will now turn the call back to Rob who will provide some closing comments.
Speaker 3: Thank you, Sean. This is a very exciting time for my men in which we are rapidly approaching significant milestones for our organization.
Thank you Sean.
This is a very exciting time for mine that in which we are rapidly approaching significant milestone for our organization.
Speaker 3: These milestones include our four-week primary endpoint toughline data and our Phase IIb trial of MN120 and GAD, which is expected in the fourth quarter of this year.
These milestones include our four week primary endpoint top line data in our phase two B trial, and then 120 J D, which is expected in the fourth quarter of this year.
Speaker 3: which 12 week data expected by the end of the first quarter of 2024.
With 12 week data are expected by the end of the first quarter of 2024.
Speaker 3: We also anticipate presenting full data from the study of the scientific meeting in 2024.
We also anticipate presenting full data from this study at a scientific meeting in 2024.
Speaker 3: We also anticipate reporting proof of concept results for MMM 120 and ADHD, with top line data expected by the end of the first quarter, 2024.
We also anticipate reporting proof of concept results for and then 120 in ADHD with topline data expected by the end of the first quarter 2024.
Speaker 3: For our MM402 program, we're on the cusp of initiating our phase one trial later this quarter, and anticipate sharing top-line data from the UHB investigator-initiated study of RS Norsemic MDMA in the first half of 2024.
And then part two program we're on the cusp of initiating our phase one trial later this quarter.
And anticipate sharing top line data from the U H B investigator initiated studies are asking for ischemic M. DMA in the first half of 2024.
Speaker 3: As we come to a close, I want to extend my sincere appreciation and gratitude for the critical work and unmatched execution that has brought MindMed ever closer to realizing our mission.
As we come to a close I want to extend my sincere appreciation and gratitude the critical work.
Unmatched execution has brought might not ever closer to realizing our mission.
I'd like to thank our highly talented and deeply committed to our research collaborators and clinical investigators.
Speaker 3: I'd like to thank our highly talented and deeply committed team, our research collaborators and clinical investigator team, our investors and many other individuals who have been supported, including especially our patients and their family.
Our investors and the many other individuals who have been supported including especially our patients and their families.
Speaker 3: We are working tirelessly to deliver on a therapeutic potential bar pipeline and transforming the treatment of advanced gate for many individuals within brain health disorders.
We are working tirelessly to deliver on the therapeutic potential of our pipeline and transforming the treatment landscape for many individuals with brain health disorders.
Speaker 3: With that, I'd like to thank you all again for joining us today. And I'm happy to take any questions.
With that I'd like to thank you all again for joining us today and I'm happy to take any questions.
Speaker 2: Thank you. We will now begin the question and answer session. To join the question queue, you may press star then one on your telephone keypad. You will hear a tonic acknowledging your request. If you are using a speaker phone, please pick up your handset before pressing any...
Thank you we will now begin the question and answer session to join the question queue. You May Press Star then one on your telephone keypad, you'll hear a tone acknowledging your request. If you are using a speakerphone. Please pick up your handset before pressing any keys to withdraw your question. Please press Star then.
Speaker 2: To withdraw your question, please press star, then two. We will pause for a moment as colors join the key.
Two we will pause for a moment as callers join the queue.
Speaker 2: Our first question comes from Brian Abrahams of RBC Capital Markets. Please go ahead.
Our first question comes from Brian Abrahams of RBC capital markets. Please go ahead.
Speaker 4: Hi, good afternoon, and thanks for taking my questions. Looking forward to seeing the data soon. Maybe just a bigger picture of overall market question and then a question on the upcoming data. Can you, so you gave some of this information that prepared remarks and it was really helpful. I was wondering if you could elaborate a little bit more on the unmet need in generalized anxiety disorder. I guess what's your understanding of, I guess what do we know about the proportion of patients who open to…
Hi, good afternoon, and thanks for taking my questions and looking forward to seeing the data soon and maybe just a bigger picture overall market question and then a question on the upcoming data.
Can you.
You you gave some of this information in the prepared remarks and it was really helpful. I was wondering if you could elaborate a little bit more on the unmet need in generalized anxiety disorder.
I guess, what's your understanding of I guess, what do we know about the proportion of patients who fail Ssris and then try Oh go on somebody needs.
Speaker 4: fail SSRIs and then try, we'll go on to one of these next line agents.
Next line agents, how many of those would be considered the treatment resistance and how are you thinking about that in the context of the overall market opportunity and I guess the proportion of patients you think would be most likely I guess initially to try a drug like <unk> like and then what's funny.
Speaker 4: How many of those would be considered treatment resistance? And how are you thinking about that in the context of the overall market opportunity and I guess the proportion of patients you think would be most likely, I guess initially, to try and drug like MN120?
Yeah. Thanks, Thanks, so much for the question Brian.
Speaker 3: There's some briefings from the reddoctor, Karlin to respond to it, but in a high level...
I'll respond briefings from Laredo Doctor Carlos to respond further but.
The high level, the concept of a chicken and egg.
Speaker 3: The concept of triggering the same anxiety or generality of the various sort of is less well agreed upon than there's for depression. So, if you've been a resuscitated depression at the label that has been given down their therapies and the concept that has been, we're clearly articulated in various guidance and industry standards that have changed the practice. That same construct is not.
Why did you not I think that's where there is less well agreed upon and they sort of depression or recession depression is a label that had been given to other therapies and the concept that has been well clearly articulated at various guidance is an industry standard.
It's a practice that same construct is not.
Speaker 3: and directly applied to generalizing value disorder. What we do see is that a significant driver value is the severity of this disorder and as it happens.
Directly apply to.
Sort of what we do see is that a significant driver of value as the severity of it is.
At the store and as it happens in many of the patients.
Speaker 3: even those treated today are moderate or severe, and maintain moderate severe symptoms of the time. I'll turn over to Dan Collins to talk for the about too much of the value generally, and I'll go back to getting to the beginning.
Those treated today are a moderate or severe maintain them out or severe symptoms over time.
Turn it over to.
Yes, I'm, calling it to talk further about July antibodies generally that's a good data set.
Numbers.
Speaker 3: Yeah, hey, Brad. And thanks for that question. You know, it's a really interesting space for us to discuss because of course, for the last 30 years or so, that as Rob mentioned, that the conversation around these disorders has been focused on major aggressive disorder for a number of reasons that have less to do with the reality of people's experience with these illnesses and more to do with the marketing of SRIs. So that we know that there's a lot of undiagnosed
Yeah, Hey, Brian and thanks for that question, it's a really interesting space breasts to discuss because of course for the last 30 years or so that is as Bob mentioned that the conversation around these.
These disorders.
So major depressive disorder for a number of reasons that have less to do with the reality of People's experience with these illnesses and more to do with the marketing of a S. R. Ice. So that we know that there is a lot of undiagnosed G. A D, which is as Rob mentioned, we see this is really.
Speaker 3: GAD, which, you know, as I mentioned, you've seen this really multiple increase in both diagnosis and GAD and in the measure prevalence of GAD, which is now been estimated to be as high as 10% among US adults.
Multiple increasing in both diagnosis of G. A D and in the measure prevalence of G D, which which has now been estimated to be as high as 10%.
S adult.
Speaker 3: What we do know about the distribution of folks of GAB is that between 70% percent of folks present with moderate to severe symptoms and that as many as 50% of people fail their first SRI trial and so they're having adequate response or have a intolerable side of them.
What we do know about the distribution of folks with J D.
70, 80% of folks pushing out with moderate to severe symptoms and that.
As many as 50% of people are.
Failed their first Ah.
Ah trial. So there had been adequate response intolerable side effects and that as many as 20% to a.
Speaker 3: and that as many as 20% seem to fail multiple treatment attempts. So what there isn't a...
Multiple treatment attempts so see what while there isn't a six community accepted definition of treatment resistant.
Speaker 3: community accepted definition of treatment resistance, GAD, we'd say it's gonna land in summer between heaven, hell, one and two treatments.
We'd say, it's going to land is somewhere between one and two treatments.
No.
Speaker 5: Is that exclusively the population that would try a drug like MM120? The idea to answer that is probably no. So people end up on the best medicines we have, even if they have side effects that aren't entirely tolerable, but are more tolerable than the disease itself. And people accept inadequate treatment, response when there aren't great options to move on to.
Is that exclusively the population that they would.
Try.
A drug like <unk> 120, they keep your answer to that is probably no. So people end up on the best medicines, we have even if they have side effects that aren't entirely tolerable, but are more tolerable than than the disease itself and people, except inadequate treatment response, when there aren't great options to move on to <unk>.
Speaker 5: Of course, the hope is that if we have the sort of look at sizes that have been suggested in prior academic work, and of course that the...
Of course, the hope is that if we have the sorts of effects as you suggested in prior academic work and of course, the the extraordinarily low rate persistent adverse events that this wouldn't necessarily just be a drug that exists in the domain of folks who is the current state of psychiatry.
Speaker 5: extraordinarily low rate persistent adverse events, that this wouldn't necessarily just be a drug that exists in the domain of folks who in the current state of psychiatry have sort of been defined as pre-membersist or who drugs have failed.
It's sort of been defined as treatment resistant or drugs have sales.
Speaker 4: out of that that's really helpful context. And then just, you know, on the MCP mod analysis that they're doing on HMA, I guess first off, could you talk about the sort of models that you're using to for the assumed dose response? Are those fixed curves that you presented or those the actual models or if not, how are you kind of thinking about that? And then, you know, giving that you're not doing pairwise comparisons specifically.
Got it that's really helpful context.
And then just on the M. C. P. Mod analysis that youre doing on on him Hey, I guess first off can you talk about the sort of models that youre using to a French when he assumes dose response or are those fixed costs that you presented or are those the actual models or if not how are you kind of thinking about that and then.
You know given that you're not doing pair wise comparison specifically.
Speaker 4: What are the tools that you're going to use to hone in on and articulate an optimal dose, I guess, with respect to inputs on magnitude of activity and consistency across pace?
What are you what are the tools that youre going to use to hone in on and articulate an optimal dose I guess with respect to inputs on magnitude of activity and consistency across patients.
Yeah.
Speaker 3: Yeah, great question, Frank. Thanks so much. In terms of the curves, those are the illustrative curves that we are using. Of course, they're very precise measures against which those are established to go now since plan to the study. But generally, the shapes of those curves that we have presented are in line with the general kind of response model that we are testing against. It captures, we believe, a good number of pencil-diss response curves that very well could
Yeah, Great Great question, Brian. Thanks, so much in terms of the curves there those are the illustrative cards that we are using of course, they are very precise measures against which those are established and it's just gonna analysis plan for this study, but generally the shapes of those parents that we had presented are in line with the general.
What kind of response models that we're testing against it captures we believe they are a good number of potential dose response.
Curves that very well could correspond to some of the healthy volunteer data, we have and the pharmacodynamics of let's see from historical studies and.
Speaker 3: and some of the healthy volunteer data we have and the pharmacodynamics of LST from historical studies. And in our view, a perfect captures a variety of different responses. IITS.
In our view.
Currently captures a variety of different responses in each of those dose levels.
Speaker 3: In terms of the tools we will use, that's one of the actual benefits.
In terms of the tools, we will use this as one of the actual real benefits both in terms of its good.
Speaker 3: fiscal efficiency and using all available data to establish whether there is indeed a treat benefit or not. But there's also an added benefit here with the MCP mod that already established big thing about analysis because part of the fiscal past is measuring against those nominated response cards. The selection of an optimal efficacy response and where the focal response curve and the selection inappropriate dose to move forward is already embedded in the analysis.
School efficiency and using all of the available data to establish whether there is indeed, a treatment effect or not.
But there's also an added benefit here with the M. C. P. Mod that's already established baked into that analysis, because it's part of the Citron school passes measuring against those nominated response skirts.
Election of an optimal efficacy response.
<unk> and the slope of that response curve and the selection of an appropriate dose to move forward is already embedded in the analysis.
Speaker 3: and PPMod. So coming out of the analysis, we will have a curve that we believe is the best that to characterize the response we have in the JARG and the GAD population. And that will be one of the key aspects of informed selection of those that take part in this in subsequent studies.
Easy M C. P mod so coming out of the analysis, we will have a curve that we believe is the best that.
To characterize the dose response, we have observed in the J D population that will be one of the key aspects that informs the selection of dose to take forward into subsequent studies.
Really helpful. Thanks again.
Thanks, guys.
Speaker 2: Our next question comes from Francois Bourboy of Alpenheimer. Please go ahead.
Our next question comes from friends swap spread play of Oppenheimer. Please go ahead.
Speaker 6: by taking the questions. Can you really discuss in terms of expectations for the GAD data? Can you help us understand maybe the importance of the effect size?
Alright, thanks for taking the questions.
Can you just maybe discuss in terms of expectations for the JD data can.
Can you help us understand maybe the importance of the effects size.
Speaker 6: for each dose, or is this more question of being a dose relationship with maybe only one of them getting an effect size of comparable to the SSR eyes that are out there? And then maybe on a second part of the answer, in terms of effect size, it is compared to placebo here. And we've seen differences in different placebo responses in trials. I'm just wondering if you had any comments about expectations around the placebo response. Thank you.
For each dose or is this more a question of being a dose relationship with maybe only.
One of them getting an effect size of comparable to the ssris that are out there and then you know maybe on the second part of the answer in terms of effect size now it is compared to placebo here and we've seen differences in different placebo responses in trials I was just wondering if you had any comments about X.
My questions around the placebo response, thank you.
Yeah. Thanks, so much Frank so in terms of your first question.
Speaker 3: with respect to the effect size, where it tends to be a derivative in relation to that contrast, that backdrop of currently available therapies for GAD. But the model is that we believe that if any of the doses being tested were to achieve a clinically relevant.
With respect to the effect size, where they potentially be observing in relation to that contract that backdrop of currently available therapies for G O D.
But the model of the steps that we.
Believe that any of the doses being tested work to achieve a clinically relevant.
Speaker 3: effect size or response, but it would be well captured and that that would be enough to support.
The effect size or response, but it would be well captured in that that would be enough to support it.
Speaker 3: that our last earnings we reported that through simulation analysis we have a high degree of confidence.
Conclusion had on our last earnings you had reported that but Youre simulation analysis do you have a high degree of confidence that if we do observe that clinically relevant response, it would be likely to result in a statistical positive outcome using M. C. P. Mod analysis. So it was not pre specified necessarily which exact want these doses that we have tested wood.
Speaker 3: that if we do observe that, clinically relevant, respond to it.
Speaker 3: be likely to result in a statistical positive outcome using the MCP-MOD analysis. So it is not pre-specified necessarily which exact one of these doses that we have tested would reach that maximum or optimal effect size or response. And that both adds the statistical efficiency to the methodology and also allows us with some possibilities for the interpretation. Because we don't know definitively what the response curve is until we get to the inquisitive study.
Reached that maximum or optimal effect size of who responds in that.
Got it.
The methodology and also allows us some flexibility for the interpretation because we don't know definitively what the response curve is until we get to the conclusion of the study.
Speaker 3: provide some flexibility, even if we see a response that a lower dose than would may be anticipating.
It provides some flexibility even if we see a response and at lower doses may be anticipating ahead of plan.
Speaker 3: In terms of your second question about the placebo control, this is one that is incredibly important and the feel of course is still digesting the appropriate controls in the context of central functional blinding. FDH guidance from June of this year highlights the importance of doing those response studies, both to characterize those response in itself, but also because of this such a strong way to control for functional blinding. One of the important.
In terms of your second question about the placebo control and this is one that is critically important.
And of course, it's still digesting the appropriate controls in the context of central functional unwinding F.
Fda's guidance from June of this year highlights the importance of doing dose response studies are supposed to characterize the dose response in itself, but also because it is such a strong way to control for functional and find it.
Our lines of inquiry will certainly have as we reach the ultimate.
Speaker 3: lines of inquiry we will certainly have as we reach the ultimate.
Speaker 3: analysis and pointback analyses of the study would be to look at the comparisons both between the what we would perceive as the therapeutic or active dose levels, what we see in the data. And that versus the two control conditions we have. We have a control condition in the truth of CBO. We also control the condition in a 25 microgram dose of N120, which is right at the threshold for any sort of psychoparachylic or see therapeutic activity or perceptual activity.
[noise] analysis and post hoc analyses.
It would be to look at the comparisons both between the what we would perceive it.
Therapeutically active dose levels and what we see in the data.
And that versus the two control conditions, we have we have a control condition in a three placebo controlled condition and a 25 microgram dose of any 120th just right at the threshold for any sort of psychotherapeutic or excuse me therapeutic activity or a perceptual activity.
Yeah.
You'll also be able to look at the <unk>.
Magnitude in the <unk>.
Strength of blinding or the different thing in terms of how patients respond between each of the dose levels to also aiding our assessments of functional blinded within the study and I frankly. It takes also understand whether there is any incremental benefit in functional winding at very low doses oven and 120 <unk>.
Speaker 3: strength of blinding or the difference in how patients respond between each of the dose levels to also aid in our assessment functional blinding within the study and
Speaker 3: Frankly, to also understand whether there is any incremental benefit in functional winding.
Speaker 3: at very low doses of them, like 25 or even in a media dose, like 50 micrograms of them, you want 20. So we think it's an extraordinary level of insight we'll have from the study that is yet to be.
Five or have you been a intermediate does like 50 micrograms other than one 'twenty. So we think there's an extraordinary level of insight. We will have from the study that is yet to be characterized by the field and that will help us both in terms of designing future studies, but also in terms of appointing the conversation with FDA and other health authorities about the appropriate controls and we studied blacked out for it.
Speaker 3: characterized by the field and that will help us both in terms of designing future studies but also in terms of informing the conversation with FDA and other health authorities about the appropriate controls in the study, like that for.
That's great. Thank you very much.
Okay.
Speaker 2: Our next question comes from Jonathan Ashoff of Ross MKM. Please go ahead.
Our next question comes from Jonathan Aschoff of Ross M. Kam. Please go ahead.
Speaker 5: Thank you very much. I had a cash question. You burned about 17 million, 18 million, and the third quarter. If you hold that absolutely flat over the next nine quarters, that barely gets you to 2025, and you say cash in into 2026. So if we call those two things the singer, we're only gonna burn as much cash as you burn to three quarter on average. So nine quarters.
Thank you very much I had a a cash question.
You burned about 17.
Third quarter, if you hold that absolutely flat over the next nine quarters that barely gets you to 2025 and you say cashing into 2026, so we call those two things the hangar.
We only gonna burn as much cash as you burned in three quarter on average for nine quarters.
Yeah.
Speaker 3: Yeah, thanks for the questions done. And so they welcome Sean to respond as well, but we're generally based on the satisfy development programs.
Yeah. Thanks for the question John.
We welcome shine to respond as well, but they are generally based on the satisfying development programs and expenditures on a quarterly basis of course are driven in large part by R&D expenditures and so as we progress and have further clarity we can certainly offer a.
Speaker 3: and the next minute is on a quarterly basis, of course, or driven in large part by R&D expenditures. And as we progress and have further clarity, we could certainly offer additional insights in terms of expectations for various milestones. And for you, the cash is made, the two are including the equivalent facility you're entering to, or any of the quarter. Yeah, as you noted, I've included that 30-month.
Additional insights in terms of expectations for various milestones.
And turning to the cash available to us, including the credit facility entered into early this quarter.
As we noted who did that 35 million additional capital.
Right.
Speaker 5: And if you include that 35 million, it still requires you to not increase cash burn over the next nine quarters. And I mean, you know, yes or no, is that realistic, you know, average?
And if you include that $35 million still requires you to not increase cash burn over the next nine quarters. Then I mean, you got yes, or no is that realistic.
Average cash burn minutes.
Speaker 5: Yeah, we can certainly, we can certainly, I'm sorry, we can certainly circle up offline, but as we said before, we haven't provided an actual call over quarter cash forecast, but we certainly will reiterate that.
Yeah.
Certainly believe we can certainly talk to you.
I'm, sorry, if we can certainly circle up offline, but.
As we said before we haven't provided that.
Actual quarter over quarter cash.
Cash forecasts.
We certainly will reiterate.
Speaker 5: or current guidance into 2020 sales. Okay, we can certainly take it off.
Our current guidance into 2026.
Okay, we can certainly take it up offline as well.
No problem. Thank you guys.
Yeah.
Speaker 2: Our next question comes from Patrick Tuchil of HC Wainwright. Please go ahead.
Our next question comes from Patrick to kill of H C. Wainwright. Please go ahead.
Speaker 7: Everyone here is Luis on for Patrick. Thanks for taking our call. Our questions on the base of enrollment for 120 and GAD. Can you tell us a little bit more about the level of enthusiasm of investigators, physicians, patients, and how this could impact the pace of enrollment?
Hi, everyone, Here's Louise on for Patrick Thanks for taking our call.
Our questions.
The pace of enrollment for <unk>, 'twenty and G E D.
Can you tell us a little bit borne by the level of enthusiasm among investigators physicians patients.
And how this could impact the pace of enrollment.
Speaker 7: and on the potential phase three program in possible launch.
And on the potential phase III program and possible launch.
Speaker 3: I think thanks to my colleagues. So having been to many of the clinical sites and spoken with numerous investigators in our study, we have a high degree of confidence in our ability to continue executing with the kind of efficiency we have, for example, to make extraordinary enthusiasm and engagement.
Yeah, I think thanks, so much so I'm having.
So many of the clinical sites and spoken with numerous investigators and in our study.
Okay.
We have a high degree of confidence in our ability to continue executing with the kind of efficiency, we have seen extraordinary enthusiasm and engagement.
Speaker 3: Both because of the conduct of the study and the interest in novel therapies for GAD for the product and it resulting, I was the guy.
Both because of the conduct of the study and are they.
Any interest in novel therapies for J D for the product candidate were dumping although they got.
Speaker 3: If you credit to our team for the extraordinary engagement they have had with clinical science and their hands on
We have to give credit to our team for the extraordinary engagement they have had with clinical sites and their hands on.
Speaker 3: connectivity with the conduct of this study. It could master a better clinical team to develop a program and like any study, it also always comes down to the ability to execute our team that's shown over and over again. Even if you do that. In terms of the enthusiasm to go into subsequent studies, we certainly believe we will continue to execute as we have historically. And having conducted this study and rolled 100 million patients in just over one calendar year, or just over 12 months or so.
Connectivity with the conduct of the study it couldn't ask for a better better clinical team took the right development program and I like any study it off all these come down to ability to execute our team has shown over and over again and you just that.
In terms of enthusiasm as you go into a subsequent studies. We certainly believe we will continue to execute as we have historically in and having conducted the study enrolled 198 patient then.
Just over one calendar year or just over 12 months I should say.
Speaker 3: we feel like, we feel free then that this can be done very efficiently, and what we can do.
We feel like we have proven that it can be done very efficiently and well continue to do so.
[laughter].
Speaker 7: Thank you. That's helpful and on the ADHD data readout that's coming.
Thank you that's helpful and on the ADHD data, where you know that's that's coming.
Speaker 7: Soon, what would you need to see on that readout to have confidence to move forward? And moving forward, would it mean another phase 2 trial or right on to, right in 2, phase 3?
Soon what would you need to see on that read out you have confidence to move forward and moving forward would it mean, another phase two trial or right onto right into a phase III.
Speaker 3: Yeah, absolutely. The A-B-H-E-H-E setting, certainly, as we get to that data availability, we'll be able to provide additional contacts, but in terms of expectations or what we need to see to move forward. Certainly a clinically relevant...
Yeah, absolutely for ADHD study and certainly as we get to see that data there that he will be able to provide additional context right, but in terms of expectations of what we need to see to move forward certainly a clinically relevant.
Speaker 3: I know it's difficult to remember and it's difficult to miss get response and that study would be obviously indicative of some activity that would be supportive of further investigation.
I guess, particularly relevant statistically significant response in that study would be obviously indicative of some activity that would be supportive of further investigation.
Speaker 3: in terms of what comes back to having given specific thoughts on exactly what studies would come next, but certainly would be challenging the administering and drugs that...
In terms of what comes next we Havent given specific thoughts on exactly what studies will come next but certainly with the challenges of administering in drugs that are if if overdose would have it kind of affecting I think overdose in the context of administering more than B 20 micrograms twice a week that administered in that study are given.
Speaker 5: If overdose would have the kind of effect in that, if they overdose in the context of administering more than the 20 micrograms twice a week that they didn't administer in that study, given some of the dynamics there, we certainly have to be in addition to look at alternate dosage forms or consider exactly how we would approach that and then be part of the discussion with health values and exploration of what comes in.
Some of the dynamics there, we'd certainly have to be in a position to look at alternate dosage forms are considered exactly how we would approach that maybe part of the discussion with health authorities exploration of what comes back to that program.
Thank you.
Speaker 2: Once again, if you have a question, please press star then once.
Once again, if you have a question. Please press Star then one.
Speaker 2: Our next question comes from Michael Okenwicz of Maxim Group. Please go ahead.
Our next question comes from Michael <unk> of Maxim Group. Please go ahead.
Speaker 8: Hi, this is Chad on from Michael. I'll try to take him to questions. So, Zorin, how will the data generated from the phase one for NM402 differ from the UHB study?
Hi, This is Chad on for Michael Thanks for taking my questions. So I was wondering how will the data generated from the phase one for and I'm for acute differ from the U H B study.
Yeah, It's a great question and UHD study.
Speaker 3: Un Soviets have given the patient the word what Minister
Patients that were.
We're again since you mean healthy volunteers were administered.
Speaker 3: each of four different doses, two different doses of R-MDMA and a dose of SMDMA and a dose of racemic MDMA. In our spots of phase one study, we'll be doing a standard SADMAD kind of approach where we'll be exploring the repeated administration as well as the single dose administration. So, while we're getting a preliminary characterization of the pharmacokinetics and pharmacodynamics.
Each of our four different doses are two different dose levels of R&D and a desk F&B man.
It can DMA and our sponsored phase one study will be doing a standard sad mad kind of approach will be exploring with repeated administration as well as the single dose administration. So while we're getting a preliminary characterization as to the pharmacokinetics and pharmacodynamics taxes are.
Speaker 3: as a women for two or two, or even R&DMA, SMDMA, and we see we can be an A in the UHP study. The phase one time that we are conducting with more granular definition and more.
Women for two or excuse me RMB M. A S N DNA and we think we can be in a and D. H B study.
The phase one study that we're conducting will give more granular definition and mark.
Speaker 5: elucidation of what happens with repeated administration and characterization of how we might take that forward in a more standardized way.
Of elucidation of what happens with repeated administration, a characterization of how it might take that forward in a more standard dosing paradigm.
Speaker 8: Okay, great. And then how long will you continue to follow patients in the face to be for a GAD? Will there really like an extended follow-up beyond the 12 weeks?
Okay, Great and then how long will you continue to follow patients in the phase two b through D well.
Well, they really like an extended follow up beyond the 12 weeks.
Speaker 5: In the face to be study, we followed patients 412 weeks, getting that we were doing full dose characterization in this study and we'd be selecting a dose. And as you could see, the scores would be condition to an oral desiring, a virus, or the key formulation as we progress and clinical development for MN120. We anticipate that in subsequent studies, additional follow-up may be warranted, but in this study, we are only going to be following patients for 12 weeks. Thank you.
In the phase <unk> study.
Followed patients for 12 weeks, given that Youre doing full dose characterization in this study and will be selecting a dose and as we previously disclosed will be a transition.
Transitioning to an old design that is OTT formulation as we progress in clinical development and then 'twenty. We anticipate that subsequent studies additional follow up may be warranted, but in this study we are only going to be following patients for 12 weeks.
Okay, Great. That's all thanks for taking the questions.
Yeah.
Speaker 2: This concludes the question and answer session. I would like to turn the conference back over to Rob Barrow for any closing remarks.
This concludes the question and answer session I would like to turn the conference back over to Rob borrow for any closing remarks.
Speaker 3: Thank you, Operator, and thank you everyone again for joining us today. We look forward to sharing the results.
Thank you operator, and thank you everyone again for joining US today, we look forward to sharing further results.
Many future.
Speaker 2: This concludes today's conference call. You may disconnect your lines. Thanks for participating and have a pleasant day.
This concludes today's conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.
Speaker 1: The S.
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