MNMD - Earnings call 3 2021 | Mind Medicine (MindMed) Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Robert Barrow

Good morning, everyone, and welcome to MindMed's Q3 2021 Earnings Call. I'm Rob Barrow, the Interim CEO of MindMed. I'm also joined today by our Chief Financial Officer, Dave Guebert; and our Chief Medical Officer, Dr. Dan Carlin.

limited your call the information, or that include, is draw is that which strategies to respect but conference with a will not of like MindMed. attention business fact to this may to I'd anticipated statements plans to contain forward-looking

the Forward-looking made achievements materially the cause actual and today's performance or as statements. date and be involve known forward-looking may statements risks factors, and your EDGAR. in from the which MindMed draw are of different to disclaimer unknown full SEDAR uncertainties our of attention may and We other results, on filings to contained

a As have may you any please reminder, questions to investors@mindmed.co. e-mail

I'm evolution MindMed This is Board growth one team, people maturation are such level very Advisory expert of of passion and pleased has Directors significant to team it alongside and organization, and the and by good I work as of that single I'm drive work and brings -- company our day, I'm been the year excellent our to honored the make expertise, believe that up, Scientific every MindMed colleagues. management every inspired of our of our at the excelling. to outstanding and as Board. only with the report that at company people

from others. the talent the Janssen and people Over Pharma, Europe, the top course of of pharmaceutical and some XXXX, AstraZeneca, our the team U.S. likes and across of GW have we approximately XX industry have many by Sanofi, expanded we from recruited the

the Board solidify mission added sector. validation and XXXX, have and that the provide our in and Advisory it further psychedelic a MindMed's business Board Scientific we approach, course the and over world-class as leader Additionally, leaders our of we position scientific of of believe Directors to

address therapies mission medical deploy but beyond. major addiction and discover, simple to ambitious. develop psychiatry, Our innovative is in unmet To and needs

these its COVID-XX amidst the MindMed to uptick programs serious platforms. options ever, to health abuse seen facilitating that our the pleased programs needs advancement that to progress digital adoption Phase we medicine accessibility conditions as I'm II drug along new mental the world in our have for of the therapies. digital a trials, of significant pandemic. treatment continued lead drug we across all clinical and substance This its and innovative a role play development in more Now has report believe than and includes day one concerns and with our novel technologies key will

we as in continue and the and enter believe have sector, achievements growth tremendous At well we witnessed we XXXX very MindMed amazing entire XXXX. to across and are progress we our positioned

Board Brazil. clinic European Mr. Supervisory as Germany, Pharma, about Krebs Directors off Board new the Mr. Wyeth specifically of of of a Latin the companies XXXX Ms. in Girassol and Germany, internationally Merz private Krebs to entrepreneur Chairman He and backgrounds changes socially Directors Supervisory Linton Long industries the Carol He on X experienced people Paulo, and growth author. in Chairman supports organization Canada from the Group, Vallone. worked America, He's of announced in currently he Frankfurt, Shareholder company, United nongovernmental the of and Veonet, Group young the was President of eye Board countries and States. of Executive member the the Board XXXX, we Investment in Field has from Council Corporation Bruce member XXXX. in to of various well and Capital the September, some economy. as difficult heads Board Krebs of in Nordic transition family-owned Förderverein which Asia eV, and in in Furthermore, which executive, in more part the as of of various is of other an our of and appointment Speaking our holds Board Andreas across Mr. Mr. children sectors. investment is best-selling São which positions the focuses as and serves

a Corporate business is leader, well-known companies. former Trustees and Vallone as scaling in track Board Ms. record McLean strong with the selling Board Director and of Institute CEO of and global she and ranked serves Committee at of serves serves Currently, Medical hospital launching, on Hospital, of She she a Brigham. affiliate the School. at General Trustees Health the of freestanding Mass psychiatric on #X Board psychiatric Harvard Professionals, of the Finance largest MGH Chair

Board a a serves Cresco investment Board and She traded organizations. the care e-commerce held as and Advisory for is Ms. firm served Director Board focused Berkshire Arosa. company, positions health Labs venture publicly an Double firm, and Longitude Additionally, of Founder e-learning an Impact Ms. of member has member portfolio companies, for for manager Advisory the Partners the Vallone of Vallone services leading Capital Bain Financial as Public the global growth Capital. CEO in corporate technology and served on companies in also

Mr. are positive incredibly of their expertise impact excited feeling our Ms. Board guidance. and already to have Vallone of the Krebs join We and are Directors. They

Scientific Rob In addition recent Roth. appointments A. Dr. these Maria Dworkin, of Dr. at XXXX Dr. changes and Advisory Oquendo, Bryan level, seen Board, has including a Board continued in to the MindMed evolution X

York New our highest a including Oquendo's research psychiatry pharmacology, the the medicine. at Oquendo residency University Tufts summa Chairman of of Dr. progressing attended A cum and laude in Pennsylvania Pennsylvania. of Hospital Vagelos Whitney extensive experience in National University patients Payne the of Professor high-risk the all in at be Cornell. efforts. and honors Meltzer of Psychiatry one University. the She University. completed will Medicine, And and of Physicians Clinic Ruth Academy of of Columbia and Dr. graduate and member Surgeons the at is College with invaluable She is her of at of development of Psychiatrist-in-Chief She Hospital,

Professor is Dentistry. Dworkin of School and Dr. Health of research the at and Center psychiatry conducting and in has of years the neurology clinical perioperative Medicine medicine, XX over Rob Professor and University pain. Rochester Technology spent of Anesthesiology on and currently He

will MindMed As Dworkin's execution provide Further, and Dr. our our complex pain invaluable extensive best our complement expertise other clinical we design clinical specific under Dr. guidance to advances to with the Dworkin's will critical efficiently assets. experience in of trials. scientific pain advisers choices trials possible of to path franchise, advance clinical the therapies making our ensure and that effectively are portfolio

Bryan spent He build Director is Dr. of of the University the Pharmacology molecular of XX neuropharmacology. studying Michael in at Department Carolina's School is also Medicine. the Psychoactive the characterizing a years of has Mental He Professor multigenerational drug Hooker Distinguished over Dr. Roth National novel North Health Program. drugs invaluable we background years Institute will extensive of Screening for candidates Roth's to continue of Drug to discovering as psychoactive come. pipeline our and be

the leaders from system. across central potentially areas reflects major treatment diseases therapeutic the of revolutionize multiple opportunities engagement represents the key MindMed This thought to nervous that landscape for

development organizational to into it I'd we With a have over Dan? better have throughout believe Dan to and advance the Carlin discuss our with executed like deliver as And we we XXXX, never we position product to updates. that, on mission XXXX. evolution turn of incredible growth our to some Dr. been in

Unknown Executive

Rob, much, morning, good so and everybody. Thanks

strides are lead Moving programs. drug advance of our we disorder of anxiety our third for on development drug one of major Project overview LSD to lead in programs. remains in the MindMed the our generalized to drug which developing quarter an Lucy, development pipeline. treatment made commercial

in anxiety taken to with under a generalized III The our clinical LSD placebo. planned into study Our dose forward disorder across symptoms anxiety be XXX single of Lucy trials. or Phase Project assess on patients will a IIb pivotal inform decision improvement including administration placebo. This will arms, study following clinical is our X treatment study the of study Phase

of optimization that on scientific based the of will the understanding the it significantly our Additionally, underlies predicts believe rigorous of mechanism response. dose study, we and design action clinical advance

enrolling I'm the pleased our the make late to in earnings to that early continued study or in report track and to begin begin preparations remain this patients very reported to we as progress study significant call, XXXX. in on last we've XXXX in

we LSD Moving on are ADHD. treatment adult which Project of Flow to in the developing for

clinical progress also ongoing, have enrolling we The we strong anticipate of this will initiation that Phase to final year. is and begin trial. review make of regulatory II We continued end patients toward the by

we year, announced our of Project the this launch Angie, Earlier a component of franchise. pain

to We for remain a of development are for formal pre-IND the pain. on advancing a to meeting We file FDA discussion preparations request clinical engage year. track psychedelics this our end of and plans before

in of Layla, make medicine diction our have XX-MC. our to to continued Switching program, advancing in also which progress clinical development program we Project

Dosing ibogaine. end of XXXX. continued. of XX-MC complete on is recall, clinical As track natural you substance I all study our remain of our will occurring XX-MC the psychedelic called the analog before synthetic this trial Phase has We to likely in

As in with a for development process Phase program reengaging XX-MC. result, II are FDA to we discuss of the our

to plan begin study in planned Phase a early enrolling participants in we IIa XXXX. Thereafter,

to like opportunity our announcement. talk about most also to this take I'd program recent

functioning disorder have the products of for the to needs. address significant company's cost include anxiety of The to spectrum launch and bring This the highlighting XXXX, and in and MDMA develop represents expansion with novel expansion diagnoses of Our autism need for team innovative treatment spectrum opportunity our is by the announced economic medical reach to and is very diversification that range in and autism excited the predicted pipeline the social U.S. of $XXX pipeline MindMed's of disorder. furthers mission to program our to a of benefit unmet program patients billion our interventions.

administered MDMA is theoretical In rationale emphasize to in placebo-controlled racemic to in clinical social X simply are in of animal of or in autism important and study It's behavior. socialization individuals Critically, social social series pilot small of anxiety scores. about MDMA our MDMA this with and resulted social a XX% anecdotal. sessions we for that when the a our believe the MDMA models drive maintained reduction autism, not effects anxiety in is that pro result

compelling bring suggest and clinical that efficacy second-generation enhanced paradigms program the novel unique potential with market of opportunity its accessibility. coupled MDMA for there Taken treatment of clinical together, and benefits to the the applications, psychedelic with to the enormous new R is pharmacological antimere

effects MDMA and pharmacokinetics and University double-blind, collaboration RSMDMA. or RMDMA with important for This the in plan Basel, with our pharmacodynamic This antimeres to of participants. optimal placebo-controlled and clinical and differences the RMDMA, XXXX assess data close Hospital will comparative acute X we its models trials racemic provide first or clinical healthy study will study trial RMDMA. between crossover treatment of in initiate and SMDMA in lasting our Through on

in trials And if done indications our clinical the in MAPS trailblazing work PTSD note, I racemic to other mention on that not and have did I date. at be remiss MDMA bringing that would friends through

are program promising excited work to their build extremely novel with We our upon RMDMA. second-generation with

ordinarily, feels Onto year. collaborations the psychonomic with she's at do to UHB and in step remain first our to Leichti partner, well that has a do other here, relationship to research several Hospital with of strange it We focus. leading contribute University without psilocybin, position Mary and but our vacation the discovery Basel. And realm her the continue Lab scientific in achieved and this would the it research. academic excited LSD, the MDMA in our

Our done by requirements position and compliance of in leadership agencies. and trials the its work other regulatory commercial strategy into translate requirements remains and drug the same, research FDA the with conducted clinical UHB

by pharmacodynamics short-acting which Leichti have the the with potential. X MDMA. insight a being acquired I future agreement Phase X II studies LSD conducted licensing and will University pharmacokinetics studies collaboration Hospital and can we psychedelic Phase extensive ongoing the study XX and I with have we UHB, DMT, the completed of includes are Phase announced this us with Dr. studies Basel, provide and into team. inform with its and as recently studies, intravenous assessments studies, of Phase investigator-initiated This ongoing of X Through part I development which his initiation, mainly nearing commercial valuable As of

which to Importantly, of to using applications rights. provisional continue out worldwide collaboration, we has file exclusive MindMed data this patent

X at of healthy LSD and LSDs XX of perceptual the to in equivalent Conference that is psychodelic of psilocybin the effects a evidence the found the were Insight in understanding first psilocybin our at In comparative from studied of look psychedelics. QX, acute and clinical a represent effects. most study, preliminary direct the dose be Dr. to the to demonstrating X presented micrograms psilocybin, of the serotonergic effects studies commonly activity Leichti LSD the we of results and meaningful In of on XXX Berlin This dose equivalence contribution similarities milligrams volunteers. of first

antidepressant. In together an treatment, found anxiety X participants. in the with with be with psilocybin the at with was increases experience safe study, weeks reduced administer looked to pressure psilocybin blood pretreatment SSRI, co-administration reduce an psilocybin SSRI second psychedelic not to prior the to of psilocybin administration, which for but effect the did of escitalopram associated volunteer Daily acute healthy and

Investors and shared we of are These the researchers phenomenology, psilocybin between in believe to the may efficacy clinical direct understand LSD. translate and data evidence provide which alike eager similarities into overlapping pharmacology patients. and

by A applications MindMed. Through MindShift our by explore may patent initial onset properties a of been with receptor safety. inspired action, MindShift library has psychedelic compounds compounds filed and Swiss the Compounds collaboration duration we novel that of organization, have already to generation provisional related discovery selectivity, Compounds, have of such pharmaceutical synthesized and and unique continue potency been as

also will entities, to potentially are future characterize us platform advancing optimize screening novel our assess which program drug to We enable and candidates. chemical these

our on Moving digital programs. to medicine

our continue work and projects digital of Division We digital our to the team. made with on progress these significant have hard forward Albert driving medicine advances

and device always, meaningful property are look all efforts relevant advancement to as on We, products in progressing intrasession and further monitoring, therapeutic intersession basis. to monitoring these the these are along that anticipate real to these several sharing digital intellectual lead software produce we process projects have world. We of dimensions medical the ongoing the of novel forward in as efforts to an protect inventions. as medicine, potential We in X modeling working

and will Through health gain A data, Consortium, therapies community advancement we and or with Society across Medicine engineers used over it tools to including digital Path that outcome, the and is Dave Data patient be digital strategy relationships, BioXcel digital outcomes the collaborations growth our incredible in Institute I turn third our the Florian, to in leading Datacc, to the [ ], Health. improve companies build the we And of quarter and unique will measurement financials. of key patient-reported foundations, significant Critical Sphere Van digital insights one enable which and collaborative Digital these innovative amounts and present with adoption Guebert, our refine medicine hope of and models our to sophisticated facilitate our and drug that, CFO, day device. its

David Guebert

Dan. Thanks,

be electronic related with analysis management and system discussion also of the along found for issuers across analysis the statements, documents financial on and can document for at disclosure www.sedar.com in complete Canada sec.gov/EDGAR. system The The filing electronic and retrieval. EDGAR at

provide of financial brief our summary I'll end a statements. quarter

all continues team the reminder, strategic research figures in being expressed and dollars. clinical execute core a its highlights activities. U.S. As to of of and quarter development expand our growth The to our plan. its build are included the on to MindMed assembled capabilities operating

items, and assets costs share-based made including loss $X for September expenses of $X.X development amortization of ended and intangible X $XX.X up was comprehensive $X.X of net $X million noncash of of million. general research million and and administrative of and Our the months million, XX million, primarily compensation

expenses million. fees million. and were costs $X.X acquisition Clinical R&D of development of and Data consulting of costs million million. $XXX,XXX. costs other of regulatory research of comprised Manufacturing-related the costs and study $X.X quarter and $X.X and $X.X Research of payroll for

regulatory fees costs. development direct and all costs clinical as expenditures well and for and programs, licensing as manufacturing, include property intellectual compensation, for Research indirect

for $X.X and and $XXX,XXX, General Relations of company-related Marketing million, $XXX,XXX, quarter fees $XXX,XXX administrative the other G&A. Investor of $XXX,XXX of fees expenses insurance of payroll costs public million, consulting consisted of and for of $X.X professional and

balance the to sheet. Turning

million. was million, Our working $XXX.X September our and at cash balance $XXX.X XX capital was

which in the option during Net turn exercises back I'll is warrant proceeds $XXX,XXX the primarily that, million With quarter. was used was the during cash and $XX.X Our financing, presentation to quarter. from operations Rob.

Robert Barrow

some Thanks thanks investor much, Dan. Dave, address so so now I'd and much, questions. like to

would in open we'll function you. have audio be as We'll on concludes, We and we And start and you analysts number that questions hand go there, that the writing. up into we free the there. any to received are for feel other raise of to then of please happy a for phone

Robert Barrow

Can ], capital [ are you From [indiscernible] there? you...

Unknown Analyst

Yes. you okay? hear Can me

Robert Barrow

Yes.

Unknown Analyst

how MD&A specifically, with mention that on Congrats also the IND IIb? note, time look I your continued needed a results Phase for execution. timing for I've some FDA. And the on then on heard around of in love with for before about think to some Layla take the Phase at I the FDA, clarity you interactions interacting I'd guess, the the just the the filing your

just Phase for what X for the also data on I Layla, then you turnaround? and some timing those So wanted side kind what the you analysis for on IIb color of LSD first expect expect of

Robert Barrow

so you Thank much. Yes.

the be on including we file as regulatory with a number to certainly, we to milestones, typically are have tend shared. those point, as FDA. going when first practice, We or have and applications significant meetings announced don't, And interactions, So requests. we of a announce

soon a so we And cleared know. let as everyone as IND, we'll certainly have

say progress initiate been year, the I very we regulatory this and to communicated. that study is tremendous will on have remain previously we track as making by end of What much that

are So engagement point. obviously, I guess perspective say about had with active go the this we've signs there. weeks I can all an at only X from year, in left our And

earlier they to certainly, data and we always the I up that and we need seek the once Phase meeting. wrap ultimately, But back the we XX-MC we're requested study front, and to a interpret study present this data FDA completed. engaged as previously time We had year currently On to FDA. come was conducting, that it package with

a move we present Phase discuss to and I Phase full package So II. into had we as

C the by Phase data days are Type to then up for year, division to wrapping really end and help we'll progressing rapidly lines meetings, the be study the XX and And soon as conclusion as to meetings, close coming FDA II on from FDA. up to we study of can those based there. engaging gearing XX-MC the we typically with submit with this just for then time So

Unknown Analyst

Got it. Got it.

So of wrap basically, the have expect then engagement and year-end it FDA. that by to

last one Just for question me.

from surrogate Given maybe prior Phase the be Phase place position and of now the come a II. be the obviously, starting in that potential where those you'd this designations the data and with discuss breadth have I to a do that's accelerated to and for would this subsequent approval Phase endpoints for discussions of think would a some maybe FDA? Or like you point Ib, something

Robert Barrow

the requires, any designations. but requirements has order that Certainly, as course, -- any expedited programs, the to those to obtain of breakthrough for will unique going that such fast data requirements, are in need clinical track expedite of programs

also we any Phase much UHB, II certainly FDA as readouts the look to the programs and so of aware very data motivated utilize have And those appropriate of trials engage to from granted, the those will but of as those designations always become to at expedited available. investigator-initiated we're get balance being very we as

say -- place So approvals. to And would a this having need designations at it's in little certainly, accelerated before about be are premature to time. dialogues start we those

endpoints, this particular, for there clinical that effectiveness. for aren't in for or point, anxiety At an surrogate justification a approval would be path

pursue by to not someone the that develop endpoint, surrogate is certainly, if and near be happy something we'd able to be pursued that. term something and in us. that So likely be interested to very to were a see But we

Unknown Analyst

Understood.

side the end point So on than side? maybe potentially surrogate substance a the on more use anxiety likely

Robert Barrow

Yes.

quite are been the CNS anything think haven't difficult point the sort generally. and for I approval basis also to

here claims. what the kind most outcomes clinical looking meaningful outcomes, So of of for intended we're label them are

this leading of something our in a programs wouldn't are -- points think So I we end get candidates that not point. priority drug or at as of terms are

as Jason McCarthy, well. up open I'll you

Unknown Analyst

] on line the is Jason. Kini Michael This for [

as bit to ask IIb. about the it relates protocols I'd to So Phase like treatment the upcoming a

but we for magnitude As the from dose the Compass, it results, one investors. psychotherapy expected was saw pre-bar-bones seems cohort for by like to significant enough not

for LSD. on the would think but different it's know achieve the a drug, establish drug similar could you to baseline I result can expect of translate to and strategy the like to how and that you find a different of I'd Phase what that indication dose? you kind dependent to So III largely see a

Robert Barrow

so yes. Thanks answer the I Yes. there much, is Great Michael. categorically think question. And

and very So such are of lost studies, excited of response is will the I in studies. even seeing there readouts that for And obviously, the applaud XXX for often, for at we conducting about on in it readout from X look study Phase -- everyone to programs and Compass be magnitude from antidepressant the in look the order When SSRI, II those think anyone, XXX patient approvals results is these remarkable that Phase for can the the II responses both if positive psychedelics look historically. most at instance, development depression, in particular, you in X you and to studies for you the study. get to it,

the statistical that XX be underappreciated. XX patients to arm, in So was can't significance demonstrate able per Compass fact to

I think it's pretty substantial.

the in is would paradigm, or clinical of what a remain forward, questions terms If But dosing Phase it's also II emphasize answers point area is of that optimization. and to it either define had we to we important open but is programs dose, the define exploration. it's there the the of number this precise all of take define to of an course, real-world duration to the optimal

in define dose, and the paradigm so the as our think optimal that into forth going program magnitude LSD an focus dose So is. is to and what temporarily optimal can the anxiety III about response understand disorder, we Phase we both XXX-patient that profile in dose in to our both to take generalized study characterize that and

go us give -- characterization the of of both narrow activity help trials to similar form. are and them doses of in you this XXX those be dose LSD and extremely a magnitude the that in are and range And see well a It know, will And but real many a dose that's before may at a and into placebo. we our duration see response to design. us pivotal of full XX, prolonged XXX other. We that XX, doses of looking help as compared one will XXX we micrograms across very we valuable of each acute XXX-microgram we will or

and we path study, we as forward [indiscernible] as can have in think approach III in that possibly the about So simplifications think learning as and we much remains approval. diligent on really we so our Phase about fastest our focus as I narrowest being

Unknown Analyst

And then just to of color I'd press in give like as on therapy point of protocol the pursue intending up of follow and more what you're sessions. on number bit a that to terms the sort you can sections and integration

Robert Barrow

of actually But to ask Yes, know and though, development accessible works absolutely. we is we good Generally, and are to briefly pared-down well. stands that I'll what be supporters with bring that need approach scalable and we as programs therapies them a in answer then is have to scalable. overall to of in obviously huge comment an well a beyond fans Dan far find psychotherapy from these do psychedelics. manageable but framework, And to big that market, body a Carlin order literature way one not psychotherapy. and in with to --

our friends protocol. treatment thank to to to drugs asset you years. mind I And so And general have who've with think, been the our that physicians specific for administering who we in great valuable relationships has these want protocol. other we've protocol in MAPS, say we've training a have of also informed defined been with, our our that with And I been our clinical it's by team at developed Switzerland framework as kind also

But please narrower a a have few I ask definitely give we on you Dan, focus. Dan, thoughts more will this? So would

Unknown Executive

critical we someone regardless Yes, here a and at that experience, in didn't get hoping experience what of balance by there as while not be be repeatable, dose are not when the get possible and points that. there it, have negative with a folks maybe significant for do be they sure. they they're the to may said, there. and well. going of day as But who ensure need reliable clinic bad may an ensure able get that you day, as rate, anticipate because And to get and has but they intention is placebo dose have experience covered not what to for trial, to conformed psychedelic to be that's some folks obviously, a the the like who we're It folks what that in Rob they looking have be experience they're to that will they an an LSD were and quite enrolled and will a

And is so sure what people are informed what that about focused in we're for. really on heading making they're

the effect to in happened the medication to start what of program what issue discuss psychotherapy we regardless on they're able of of as without status engaging experience to confuse that of ready out, for where was to the the come that. So that have, And they they they're they them a to extent what was their effect. report feel psychotherapeutic the and effect need they the and that

So to there. we range it with good strike practices a balancing has trial a of and psychotherapy balance in be been we of clinical team as psychotherapy clinical the working experts but is general psychedelic, act, can sure best as and across

Unknown Analyst

you if on and for mind, your anti an hop ask repeat And particular to because one sort I'll next-gen don't thoughts target in All paradigm. dosing the queue. discovery back low-dose X-HTXB one this right. wanted that's I in program of represent What last activation? a on then does are And your the programs?

Unknown Executive

you Rob, wan't... do

Robert Barrow

over on. Dan Yes, to I'll that as well turn to one comment

Unknown Executive

Yes.

bit probably to risks is that be on And of of as is as paths adverse be to. risk of we X-HTXB then need down that as that we something a fact, can It's XB liabilities. And we end, to But at explicated and adverse of not XB continual with or of next-generation maybe in it or direction. well downstream taken a as an periods that's into molecules as said, necessarily question staying in because in, in important lot field the the the agonism of as certainly, dosing, include be that liability going pretty the continuous characterized those so past. develop experience some consideration that entire dose been action intermittent you as more for more have very that by responsible thought pay Jason, and field informed a something proceed described to give seems it mechanism in between the attention events is the of certainly significant the obviously, we needs for some we to times we're dosing get well. the XB And off that if, faith digging events than aware is to

here, work as so to be So absolutely of with paying but lots it. attention to many done, things

Robert Barrow

Great.

I of we'll So any questions were couple we investors@mindmed.co. more that, welcome questions, with that And take if in has previously. obviously, them anyone a always sent at think follow-up

we one question Angie, Project disclosures Project provide in from or you on investors any expect Project have relation Lucy, asking when update HealthMode? investor So can may an an material to Layla,

And as working on all are we feverishly do so. if these where look year, of that to a there deck Certainly, our ensure we I the the cited you has track hit and hit to that our milestones in everything that remains number by we think team corporate today. are our are into end progress those covered we in and been of

as So certainly, webinars those meetings will any announcements. of we we discuss those happily And hit to disclosure, be be more become would available have or or making of further. up milestones, we as setting we data depth

FDA outside within I Cosmetic of Class definition you as devices on of Food the regulations, scope pipes? software of will medical medical Drug of separate the regulated ask candidates each Can others components, to to Dan last -- the number filed of of a stated company consists product which more, is MD&A product platform with that exemption, respond the the product or respect consists to that each be of in company the excuse -- that the and a underlying this is then elaborate me, nonsignificant Class was fall and FDA ID some a going and may as I'm to the of devices. not Albert week, II and scope Act's question anticipates be And contains the medical will risk one candidate HealthMode, candidate

I'll with is an And think this ongoing here discussion FDA. I what say is that

active of desire develop digital an medical we devices, Certainly, as engage and intend medical software a around to device. our as program medicine products. have components, some these We FDA to

of that. out some scope them fall just And the may of based on

lines claims fall patience. the and those active is exactly status We an appreciate where everyone's dialogue. So regulatory between

soon bit these the Of effort so are ask our tell for that continued we'll medicine course, been disclosing show quite much that. and forward digital we we then point And to a certainly develop in that a we see. product certainly And we'll we of more. to regulatory and a to engaged everyone around as forward as future, doing in displaying some look at strategy bit we've But for the for patience our as as quite work everyone have on development look able, are side.

So, Dan, to if want add please. anything, yes, you

Unknown Executive

evolve to guidance. field comes figure Maybe software device, about time the our just continues with a about rate obviously both to to they medical and little relate for boundaries that as released it digital contribute to time device. medicine. medical we then products has and from And color agencies the regulatory that out The on specific science a there, are that them through general what guidance together in agency conversations when agency topics folks is working digital working are and which medicine constitutes thinking ongoing the to as where the to the and

company-by-company these of basis. can on Some conversations happen a

group Critical we're which C-Path, of which as Initiative, are Society, a Transformation CTTI, we in of, participating Institute, Generally, which in space member Digital course, of well. and Trials we Clinical better are they're pretty like we think a that a a now Path Medicine now member competitive held with the

together of groups agency and can each to the building products think folks edges where these boundaries help regulatory are. about So the and

I a we contain will that about software regulated. if may and, intended things, device is say the a of clearly from as software to perspective, platform provide we build function therefore, general think medical as be a that

maybe say, information right? something alongside clearly think medical provider that general platform, components, may can or a And components or are about blurry and and medical be what isn't, if informational same clearly what as that is about components, clearly in of aren't. platforms, there living we the imagine that talk line not are there support components clearly So or envision interaction You could devices, of yes, we wouldn't facing measurement inter-patient resources, when be patient device. again, either those decision we such support platforms as that device, components a regulated or medical that would be clearly

to we is -- keep thinking those able path medical a isn't as these all without conversations know and disclose So to the I it's our about we as what But things, that device. in you down go on tricky are certainly, what we'll loop specific regulated and having have it's products. disclosed

Robert Barrow

today's follow-up Thanks, like Dan. contact much, A We'd submitting anyone concludes to so questions who Thanks earnings call. us here recording of has being and Good. to investors@mindmed.co. for at everyone, today. That for encourage forward Thanks, website next to today's together being for so the everybody. call We will you after be many thank to on posted more And we're our again, here. the time call. look come. much questions and

Mind Medicine (MNMD) 17 Nov 212021 Q3 Earnings call transcript