MNMD - Earnings call transcript Q1 2024 | Mind Medicine (MindMed) Inc.

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Operator

Good day, and thank you for standing by. Welcome to the MindMed Q1 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Rob Barrow, CEO of MindMed. Please go ahead.

Robert Barrow

Thank you, and good afternoon, everyone. quarter results first conference corporate our call. to XXXX and financial update Welcome reporting is the our financial Investors press being quarter our The release XXXX, XX, results Exchange Form for section is Commission. our ended March on today & of available and website report and with quarterly filed XX-Q the Securities Media the in

such product certain safety, During today's approval progress the with candidates, XX-Q the as the with without potential efficacy regulatory processes. associated These report limitation, difficulties SEC, and expectations, regulatory including, including and anticipated our filings made of call, subject we prospects. These our factors market plans, Form Form changes in our conditions our our various annual forward-looking will XX-K other runway and and described cash being partnerships statements statements, risks and be research and statements clinical and making on today. to development and future risk about are filed in and are

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

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

Officer. Earlier Officer. who an as no We next support May announced in transition of for in serving Dr. want identifying Chief the hard the to assist our the is our Chief future MindMed's Dr. company, Board of endeavors. Daniel executive X and in to Lilienthal, Chief all behalf we Karlin, I Officer Medical over longer luck best to Chief of Joining the work Commercial a and Evolution. his me wish Francois the past to mission Greenway, phase X, on Schond and Financial search the his retained firm dedication as call of Officer; our our and On of years new Schond him of are today's today, thank Financial growth

to results. quarter our back Moving first

providing in We therapies. are update and breakthrough excited positive as for therapy We intended emerging for to start period trial over in the drug for which existing treat compared that may reserved a Phase are this FDA been demonstrate financial best-in-class This year this It was preliminary care. important substantial designation productive MindMed, and a highly therapies indicates business be to has GAD. a the this MM-XXX's potential that we to during MindMed. of which or IIb data life-threatening condition fantastic improvement with to data, Phase as anxiety the to treatment for serious highlighted in positive an announce trial receiving thrilled the IIb is generalized standard evidence a for FDA believe of we our today's a of were designated shared the and that designation clinical product the treatment reinforces from GAD. Alongside or XX-week MM-XXX MM-XXX data clinical quarter disorder

offering the and to other MM-XXX important have it before concurrent offering-related in offering successful MM-XXX the expenses. raising the underwritten the fees data in of On private million transaction oversubscribed other March, institutional blue-chip care included deducting investors, gross our proceeds we Participants its the the which fund completed been the in we and for financial we year. Most strongest this company believe most that $XXX of great respected some that further will in able we work heels importantly, and approximately health past a placement pipeline. in in ever, financing development puts programs achieve validates through MindMed expect milestones position and

Congress announced the Association medical of and of XXXX the various the and poster Pharmacoeconomics and GAD, at we International results which related as remains presented Psychiatric meetings. cover posters of we XXXX American This Conference Research. These from April, Congress posters the Association's Psychiatric Phase believe for In presentations GAD, scientific Outcomes of that as Finally, IIb detailed well America Boston. trial we at we Anxiety of and presentations European Depression burden then shared growing Association's studies and epidemiology month, underappreciated. XXXX in and have in presented we several Budapest, Society data and our to Hungary, MM-XXX

from Austin, XX represents in our we visibility anxiety work awareness meetings Basel disorders increasing results for XXXX Psychiatry these at a the will key of Texas. Overall, X-year Phase Society strategic important initiative as MindMed's scientific profile MindMed be through look community. within build Additionally, in expand sharing our an study Hospital the being scientific our as to held XXXX investigator-initiated and lysergide in Meeting of May the Annual from II follow-up of X collaborators University of treatment Biological

prepared comes disorders. health appears that years. In and brain historical XX report found it having to the better the situation significantly at Substance past epidemic lead indication, a second the GAD, GAD diagnosis, the symptoms of XX% decades the comparison condition the last adults of old. among have making our studies crucial in tripled years Administration, mental GAD, with common recent for grown or that study most time adults XX address health prevalence In Health A consistent disorder to X an Services of that has the U.S. prevalence with to alone. progress urgent for Our the several Mental mental Abuse health to need for a over example, treatments worse was

progress XXXX, MM-XXX data results target in a and durable single for dose and extraordinary tolerability demonstrate just for a represent of standardized context these all these innovation from practically in more after the exceeded than XX size that improvement up in of data that of X-week in field have trial suffered MM-XXX, major in MM-XXX intervention. effect demonstrating therapeutic the fast-acting Collins the positive therapies XXX-microgram culminating from has has no a Phase activity seen weeks our additional forward years. December March. XX-week step favorable in GAD, double a ] XX weeks past a that the at available shared [ D standards is X.XX endpoints have dose in to group The be subsequent X.X without are on Our attributed absence IIb the current the product conducted can the in for the was an trial currently data estimated significant result profile wholly care effect MM-XXX for believe along Results sizes the clinical with any of the follow-up we any announced over We our believe stand-alone therapeutic We of profile. In intervention. the the size estimated past below we analyzed effect this in to of program GAD of which to other GAD year, XX and average. as effect

results We of formulation differentiated II III differentiates enhanced achieved the of Phase its development MM-XXX's upon the we to quarter XXXX. reported decision curve formulation our and a into tablet, having new the clinical program the development as benefits, such believe also our successfully is formulation. well progress formulation under meeting PK bioavailability further therapeutic area from property second Phase clinical trial increased III on III intellectual dissolving that of exciting that ODT GAD. demonstrated have half ODT concentrations of our to MM-XXX PK progress, as program pivotal numerous of to FDA of Phase benefits compelling aspirations profile our trials profile believe or provides MM-XXX initiate the with development. With scope characteristics goals formulation end MM-XXX's for ODT second the We evidence and what to bridging III and MM-XXX of including bridging supports in our for Phase XXXX of the off the clinical performance align delivered MM-XXX profile. Overall, trial into this expect ODT the for for the and the anticipate as extending Phase evaluating orally an clinical product clinical Phase we The II we in advance in product

Additionally, indications GAD evaluating such are beyond for based best-in-class on overall program the development data indications promising we GAD, in clinical the depression, and represent actively have beyond. treatment for the believe observed may MM-XXX for and MM-XXX additional we as

we towards commercial As focus in build planning. our momentum development we are of enhancing strategically also MM-XXX,

patient approaching has infrastructure, their you of which marketed. it may psychiatry trials ] success [ with March, MM-XXX helped As established Analyst the the from and approach Day of successful impact care REM's model. This ] of beyond extends includes aligns processes [ XX% clinical and practitioners, change Johnson's market Bravado [ readily MM-XXX, model indicating all documentation ], in we use Bravado's the the our care enthusiasm own strong psychiodelic recall is with anxiety depression. FDA intranasal be reimbursement positive way approved logistics rapidly sentiment and treating esketamine will its and research treatments as case ultimately for well-defined leveraged or health blockbuster in can pathways, a by for believe that for & Johnson interventional pave FDA-approved which status. surveyed This shows

of communication ascending and in effects clinical our administered intended which from and MDMA R(-)-MDMA we MM-XXX, or trials, quarter our the MM-XXX's the program in collaborators single fourth that will further of expand the pharmacodynamics believe of that to data treats our I product results MM-XXX, [ is S&N focus quarter anticipated significant develop trial have XXXX. This of XXXX. of now to symptoms. Our studies therapies promise UHP difficulties. Remarkably, of of currently approved expedite MM-XXX MM-XXX potential adult in to preclinical the tumor. pharmacodynamic XXXX. our tolerability the and is ended understanding prevalence symptoms I a particular, racemic efficacy RS, exploration pharmacokinetic our are pharmalogical clinical early effects for trial We core a the supporting at ASD, tolerability, approach, MM-XXX its from profile believe comparative our quarter program of The enable second the volunteers a and with ASD MDMA. we the daily signs ASD, and and development. We'll evidence increased financial profile March pharmacokinetics holds or no Phase the conducted as in disorder, lead is second robust results in despite later-stage ] autism of regularly trial for characterize specifically trial clinical turn versus doses population. And of [indiscernible] of to into healthy at With [ this is social the the Phase ] targeted there dose initiated XX, progress first of repeated will the characterize currently, We favorable core of MM-XXX spectrum prosocial

had company of believe totaling $XXX.X to the XXXX, $XX.X our December cash XXXX. to XX, XX, compared cash and million current plan. March on as into be equivalents sufficient our cash and of cash As operations our XXXX equivalents based million We fund will operating that

For capabilities. General as Research in expenses development million period for ended of in period million compared $X.X an XX, same in period expenses the $XX.X for the $XX.X ended our primarily $X.X in increase standard costs were and in in the million. XX, on XXXX, and primarily to same program, of of time XXXX. used fair changes in the ended a to million business. Company's XXXX, the was representing March operating This related to $X.X and million decreases is warrants a compensation to very March million was increase million for quarter increase the This that March $X.X activities, $XX.X that of increase increasing an a action MindMed. we net count increase of potential XXXX, our cash to the support of the expense development XXXX, of of same attributable stock-based million March conclusion, expenses million result an to XXXX, the administrative exciting MM-XXX expenses million. compared activities personnel-related million a to product compared to $XX.X for value was due for $X.X $XX.X preclinical an period research of the XXXX quarter increase net same XXXX, $XX.X for quarter emerging financing the due MM-XXX's $X.X for believe GAD this compared $X.X internal $XX.X quarter million by million increased primarily loss in to and decrease XX, of an mechanism ended of and was head partially $X.X in the million MM-XXX were understanding of of $XX.X profile was XXXX. decrease due growth shows and today's share offset decrease dollar personnel related to our in data to validates best-in-class The million of for U.S. the for We XX, compared million. In to scientific care. in expenses

to excited on II be this Phase expect program, the year into FDA. Phase of cusp second anticipated meeting the with in half are our III which of with We the moving we forward the in currently following

like our the my critical appreciation call, our the to our that MindMed our explain closer talented gratitude I investors many have including and individuals and families. other clinical want concluding deeply research investigator especially patients unmatched has to team, committed our mission. and Before work and sincere and our to brought supported, thank collaborators their and highly who been teams, I would execution ever realizing

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

Operator

comes Instructions] from Our Leerink first from [Operator Li Partners. Rudy question

Guofang Li

Congrats on the progress.

FDA an AdCom therapy hosting for [ is ] So its announced that just MDMA [indiscernible] meeting PTSD. the

about can this topics implications MM-XXX for you maybe the to you're at what key the looking meeting? curious just and talk So AdCom are that

Robert Barrow

there action, an of advisory the generally they're MM-XXX of treatments distinction invite classing, this. studied, draw a so committee entrant well. We ICOs much, field, being expect how for And for and message think, MDMA the Dr. advisory clear such administered company to start is PTSD. off distinct a committee any is and way clinical instantly a expected we as Rudy. in as to in as to for between Thanks the mechanism as which important program comment Yes. and novel developed certainly, we drug be it first it's but would I'll Karlin I

hope I into commentary has trying much we of there's there be occurring. the think across some and So to to expected been to and read read all board publicly us feel into this and be

[indiscernible] the LYCOS [ following And ] the ] subject on of of to for we've points very matters understand advisory [ terms will program. and ICER committee. In be report looking closely interest seen

feel scientific program [indiscernible] of to outcome interest in We have addressing are that to of very our questions. But intentionally that areas will for FDA's guidance many advisory [indiscernible] demonstrate from answer our the day X, follow confident questions the continue best-in-class to in field designed been we have covered to members to the presented key MDMA? rigor they and and look and committee from approach those and successful forward hopefully and a will

Operator

comes Our next Capital Brian from Abrahams from RBC question Markets.

Brian Abrahams

this both were could like APA looked was At directionally, but presentation, just, and and were over then here, time and they there. PGIS, HAM-A secondarily, I that's on differences some subtle both the think, could showed about there in the maybe effect. the what change of that how based trends and what potential guess, it some evolving you you I the I if underscores other similar, recent really wondering I talk mattress antidepressive be here case think base for durability impacting administration your is data? And

factors move indications major there. you're I to going so and alluded be are about specifically the And the disorder hear be whether considering other know depressive some depression thinking you it bit I you -- to potential or indications to little or remarks, but guys prepared curious sort this more not of a in the how determining might to in that be what forward what of what in I'd guess

Robert Barrow

then first Dan? the I'll to Dan Perfect. talk second address maybe over about I'll Brian. your question, one. to turn it

Daniel Karlin

the question. And thanks absolutely. so for Yes, much

across and extent, publicly far, the look we we've of agreement so directional is shown we different data a large when that measured what So as see magnitude all agreement to very well.

X an these administering of in So up the each is we're domains in X they real, seeing general, artifact gives confidence that of not pick a the is of scales or [indiscernible] us scale. that method different scale effect particular different

more CGI blinded a slight patient's radar that Of experience fact a may concerns by than is seeing the treatment. But determined the slightly it seeing since be we're PGI to any in a to particularly reflect want across the things strong give that week doesn't XX collected the us robust the speak Rob, course, on particularly we're as going individual by different such you me or the activity drug, clinician-rated about do about [indiscernible], PGI, want significance of you measures. to? do degradation

Robert Barrow

first anti-anxiety just that HAM-A on standard I too, obviously, gold the point, note, that value Brian, for is would scale approval. absolutely. the Yes,

-- the FDA. XXX-patient to we to was we're going focused have had at a at at while here, XX remember with in endpoint II Again, our arm looking about you and comparison be conclusions he we We So talking that's look where around study. talk the that pairwise Certainly, study. dialogue about looking we're statistical Phase the per power comparisons robust large we're pairwise secondary on the HAM-A. patients in

those the has changes be larger significant same progressed a the in would -- be effects and saw likely [indiscernible] that look at we even population. So numerical to if

of the actively indication, is we're additional depression something we've publicly, which terms and about that alluded In to before assessing indications. spoken

in in opportunity drug uptake. depressive psychiatry, for health and look sense, quite believe mental the think getting and as drug the and really indications in strong magnitude it of such we course, brain kind has clinicians landscape broadest looking major promise how hands that changing think a academic we've interplay the class and of other anxiety of the has making related look the talked about the the impact direction makes broadest about at the and overlap sure lot is and what of we of I terms bit -- as this of in country. Depression in of we at and a the this can a at really health achieve we disorder of a

effect the in we subsequent the would when and obviously with to [indiscernible] indications, right be So we'll and come the the something of that if there in effect clinical done II an development it depressive clinical giving and magnitude a showing future. in think at we'll very colleagues on our and to response time a guidance exact durable scores, at be it's indication XX-week we our building we've a prior any in provide closely major guidance obviously from at of for Phase further the top study potential [indiscernible] point disorder. There's on that the study hard antidepressant opportunity on overlook determination looking --

Operator

next comes Charles from Cantor. question Our Duncan from

Elaine S. Kim

This is Elaine for on Charles.

Just presentation at important? you do what in have most I matters? improvement And feedback what on going your And was receive curious back I'm the [indiscernible] KOLs, towards for perception the also the APA. the a XXX. the to just durability follow-up was

Robert Barrow

well. Now to I'll over that to as it turn one address Dan

Daniel Karlin

We all different Thanks, Yes. on of types focused the efficacy. different get aspects Elaine. and are feedback different of folks certainly

are say, available other rapidity scales look that clinically those tools fact effect, significant saw I notable. effect course, we of have treating combination the to changes them. of think GAD, who suggested, drug there as X like eliciting strong look at does durable measurable for the are which that unlike clinicians you folks is the this statistically and who soon and folks then, durability, And is that take are and rapid so on are the particularly people X it a on really in as day ground with significant was we as

So these warmly data? folks received across see to excited and the very are appropriately board,

Elaine S. Kim

I what product from XXX PK be and favorable pending envision ADHD. trial, to XXX, for you target tolerability do profile And Phase the profile for

Robert Barrow

the have we like to implemented symptoms, ] here is a level, are analogy mechanisms not is [indiscernible] have to are the ADHD. participate certainly, targeting communication core that of workshops that the autism. The administered high to to while treatment the well. a would ] in target that a social FDA [indiscernible] different ultimate [indiscernible], deficits communication through but [indiscernible] and the would social for regularly R(-)-MDMA intervention tonicological very patients we effects, apply [indiscernible]. aid in patient the deficit, RDMA disorder, drug with different and of the often the to [ autism treat better approved autism in things deficits, Such [ draw [indiscernible] or the equivalent At described focus no a as used core with as and believe have is therapies in the potentially that aid having will better goal same in communication Yes. pharmacological in And treat

would more would social product really So to allow be participate administered and will individuals abilities daily that the a them in occupation. communication their product aid regularly ultimate in profile

Operator

Our next question comes from Frank Brisebois.

Unknown Analyst

This for on is Dan Frank.

give differences thinking study? Zydis the Phase Phase specifically, Firstly, similarities to Phase us PK the how on you're formulations III, the the of could with planned some you the ODT III regard color does that design impact IIb? design to And or about anyway? Any

Robert Barrow

Yes.

the identical of Phase And will going if to studies clinical feel we have we those virtually right -- intend into to view. prospects and given the meeting PK no we're terms forward the go in forward statistical encouraged agency our but a we're studies. similar, report and believe clinical that So III that alignment we certainly certainly what our in on clinical forward qualitatively But end of in and date, our as we determination seen And the going go we've the final were of the comparison plan formulation the not study, optimal has of both complete and with III to we interactions on purposes from path investigators understanding a report and trial with itself Phase about reached results high ODT the design to I to there. the that of as approach comparing that the bridging in be dose exception to II until of by program. design quantitatively Phase the in protocols Phase placebo. The XXX-microgram a III by the the and really that overall trial. to but particularly Phase degree our results of sort impact extremely design for that XXX-microgram Phase pivotal trials we ODTs, reserve study, of also large, II have the encouraged We with mentioned, talking is the of you

terms about higher So potential study the of design, conviction of even clinical but that really in impact formulation. no

Unknown Analyst

That's helpful.

one in Just how trials? on data And talk new at quick if The data? potentially that one. opportunity the epidemiological presented used you the about in X could tool, the APA, next that's market based that GAD screening new being that's was -- any learnings regarding GAD

Robert Barrow

Yes. to patients X turn back screen to are going I'll first utility for potential mention perhaps using that We Phase of the to it talk GAD it to certainly again. and portion III our be then over clinical retreatment. Dan open-label once and program of the about

GAD have will So are into period, then symptoms have where screened, then present retreatment. of opportunity it there'll and opportunity if the we our after XX-week open be to patients label double-blind the over roll a X-month study for

things the who severe in I disease. epidemiological GAD. the a patients diagnosis the the populations and pharmacoeconomic received our one patient is have of haven't yet patients diagnosis are observed with think received most And costly GAD symptoms burden one have all and disease of have but also we've of research that who data GAD and

population out particularly suited GAD, that's Phase become well certainly, patients of underdiagnosis the provides and be majority and GAD important for this our a And to massive using really tool ultimately believe both treating vast the available of hope opportunity anxiety. But part going like able we providers given underappreciated to USP the GAD world. certainly an we add the I'll prevalence at be the III Also patients STF's by are the pickup to patients, have Really, toolbox will years for larger we diagnosis out, you of and the for turns [indiscernible] a not X [indiscernible] who the in in kind of of recommendation help. Dan, to that forward. be what utility there's to it by tailwind you have all have moderate payers, GAD on because of to these treatments looking over the of turn in overall severe the in been anything clinical finding the screening many disease a of program. expect go today with tool it to real we'll patients without we if of a As

Daniel Karlin

Yes.

learned what from epidemiological I mean as So an this work was is underdiagnosed condition. assumed that we this we

all this up that undiagnosed costs individual And employers impact be well. What there's the So despite care diagnosis, had with ought adds particular over folks high care really a to about with respondents the a on health and around those but GAD utilization of to its positive XX% walking have likely folks is diagnosed study, evidence been GAD that this [ USPSTF a who prevalence of past support We cost ] to over had the in GAD. obviously, the just tremendous a on these as year health XX% in and it's screen X of from on of individual just well-being, further distress, but diagnosed recommendations GAD. never learned are folks bit also screened.

expensive essentially more disorders So PHQ-X for depressive PHQ-X disorders. the has the anxiety depressive to be GAD disorders, equivalent frequently X anxiety used for to years pick past is the more been to of some XX disorders. XX-ish over years and up the

current are is for ends data so the to supportive health folks primary disorders care settings reflected care and be in the about who in environment settings. And younger. what up strongly weren't that being And we tend of and diagnosed other screening

walking symptoms and without in their as or not XX a XX, around So result then diagnosed, early that in being the diagnosis developing not and to a able is being XXs years end, getting people what treated. happening that is XXs go XX, be likely even distressed of anxiety

that benefit gets that the of illness to the believe And accumulate? treatment and our other to and disorder we from people illness impacts intervention gets before and screening the continue in so to of [indiscernible] comorbidities earlier course

Operator

from comes from LLC. next Sumant Our Instructions] Kulkarni [Operator Genuity Canaccord question

Sumant Kulkarni

MM-XXX the program you developing XXX. other run trial depression? on be GAD results get potentially a what and thoughts clarity with you're is And simultaneously to are more you ready there? So organization undivided on Or with GAD are for focusing attention that in program the doing on pivotal on your would that latest things until

Robert Barrow

so No. Yes. Thanks Yes. Sumant. much,

earlier, look taking opportunity depression market a at very and and As I dynamics mentioned the certainly related are hard indications. and we the

the technical I, ability to the the our the currently all built with programs, what's with and multiple years company pipeline. up take ability far development to on of done over ground the so beyond past We also course, -- with in have but the really X along on have executing programs from to way

the infrastructure something multiple pipeline the that in and past the execute years. our been our ability working team and been over So we've several have programs towards been to and operationalized doing has

are which MM-XXX efficiencies potentially like and position the course, there execute we indications so potentially on a we'll lose other of long and in that quite is, even multiple certainly operational indications bit parallel. We instance, in furthest And be never of focus of depression, our asset, expect overlap. believe furthest in to on in we've many operationalizing as conceived But for along a clinical program, GAD.

a of team's in we in a program our opportunity XXX. indication So the indications give based certainly we'll health. depression But and be existing and with to decided there's a a further and number in other evidence brain on second to in based believe position guidance launch abilities on

Sumant Kulkarni

between follow-up, most FDA's with Phase where what the think the end potential you a FDA, versus the plan differences as be? of you might propose Got it. hold outlook to meeting do potential you II as And your might for

Robert Barrow

sort and we arguments agents. extremely with the wouldn't and hashed privilege working make have of certainly been And try years. this had follow We in and program. we to to guidance or a want regulatory the but we nuances the very listen easily five much and for agency they've drug any to try had when drug division so in always much sort But very out. into discussed and the view of true thoughtful, logical I rational productive it's particular development know I've the in appreciated class for the be any it's obviously past interaction. dialogue conversation past there's scientific said, go to the on with needs the that to or extremely the And in of there's speak we've

expect going view and So continue would I'd and to had discussion. where much be points But have to large, some this very be say particular a by reluctant for and think I expect very we dialogue that to partner date a in and constructive we FDA into of Phase II. as as as speak there FDA

Operator

Our Piros Rodman. Elemer comes next from question from

Elemer Piros

without if large to the you Rob, on heavily talk you the I'd population IIb little is in IIb And trial, mind would addressing is population there, -- bit setting with III there in undiagnosed MM-XXX you wouldn't that considering Phase your based being that was. especially your et used, cetera. pretreated, Phase do where a about treatment. we once how agree fit commercial MM-XXX Phase like Where the design a see get once FDA,

Robert Barrow

of a opportunity some when the data be trajectory patients we of in as MM-XXX sort part field, seems of the second have say I'll the fit think practice, in a conceive change. who severe take on question over been of clinical really could the world the real concept a to that what constraining could to first, where most over there's therapies of views in only we're for a which reserved I seeing in and So the failed be is that else. And everything these there clinical is

who that life of observe on is a in health comorbidities system. you're have having on and/or we care impact they and quality the their also And impact end going huge have the so doctor related undiagnosed to GAD the years -- a huge and up what GAD particular, go spending severe in patients

GAD. comes from Now a knowing to that where on also severe go the talked burden those in from We system financial GAD talked not we value are the care undiagnosed walk who health patients has to of about reimbursement. view point the they about have severe around

see is than failed the who more far actually have patients we simply opportunity expansive everything so out. And the

we're enormous focusing marketing be certainly therapy is se. a obviously activities Now on value not But as severe commercial treatment with we be benefit. of potentially gained believe patients going likelihood in severe the disease. by going the prior a there to that course really who our aligns are and expect been end to we that first-line everything to And to is not and to certainly treatments there's also their have and say and at patients had the who else focused per believe able [indiscernible] who are be We that could that data we've generate.

largely our representative a trial. mix that Now the population we nice of in is clinical real-world see

of on difference slices have look and When meaningful we a treatments treatment there's focus different we numerous in a response impact more patients see a portion much in I certainly, don't both from prior but a line resistance that and GAD business So again, somewhat at think data, have the a which, and significant patients, of last regardless it's the we of think history, standpoint. scaled a from favorable, depression, standpoint treatment clinical definition of dynamic of treatments. better between prior is

Elemer Piros

see difference think you then other some sort different [indiscernible] one with diagnosis would is of a -- before GAD. that to significant diagnosed, the there try ever? journey they do a is And what sort in opposed between versus Yes. the newly physicians depression help get of as patient if medications primary of

Robert Barrow

I'll happy and that, turn to maybe Dan Dan? over initially extend address to on to

Daniel Karlin

patient Happy it's good I Yes. address. a question to try the really to think journey. And about

periods MDD mood. [indiscernible] they in diagnosis, time view spurs about when have with and we is is think of normal It's much GAD are periods think we between to while of episodic. remember differences cyclical that I a illness what depression very the MDD with overlapping

not regularly even Their would very raise folks care. target depressed falling likely clinician. With their see folks a necessarily patient it the the a into state care starts maybe contact more a state, going of of And though both what so usual want And from we're these course illness. they're sort seek earlier change have to into journey that with as conditions, deeper with primary more of in dive as state we a seeing disorders often specialty care, seeking to to into rather are feeling that to of at insidious in of the psychiatry of new again, psychiatrist psychiatric nature provider. their this of acclimate partly not given can GAD the due to often, first-line of availability a and deeper they're primary to the way GAD who care folks and providers prescribe. level And of may primary in the seeing treatments is they distress, later care sort the with be onset doctors of epidemiology lead anxiety if

things both anxiety point, like for a SRIs, have disorders. as toward So anxiety or moved starting primary depression and and care depressive

with difficult It which when the treatment more in driven benefit availability. As either was prescribe. to sustain the primary ], more first-line commonality the these folks antidepressants a treatment treatment previous intolerable is doctors, to or with the as like effects that side that be or show setting to care care prescribing, that enter know the frequent by brought are things familiarity resistant generally MAOIs to care system. But we themselves not to more weren't primary them for have that patterns and folks into Tricyclics way SRIs maybe severe [ be comfortable psychiatric are is

care, we are where availability of on journeys The the while different getting treatments care of sorts patterns patterns. of so current can reflect what people care. changes of those And

how we're we extent to are today, very world built bear able is about think disorders. ornate that around toward happen while to so on these what an And we absolutely a also much bring to things creating

Elemer Piros

Then don't just you mind. if little a follow-up here,

a centers. believe be to you're I'm going therapies. sure practitioner not medicine specialized some because prescribed would administer by a psychedelic be these you're administered at They that treatment not general a only going specialist, after specialist. are all, to or So people whether

actual of you involved Do not or in line you're So going disagree thought? agree directly to treatment. this the be necessarily

Daniel Karlin

of I on Within that, there a parts bit. we absolutely push that might agree. we parts, are back other think

safety the around And individually. as IIb, be to evidence the be and with lower This So are the sorts MM-XXX And we cases, with with to has appropriate affiliated provider with build be prescriber have care today involved given monitor efficacy appropriateness can are for the prescriber they centers. with that specialized which we of prescribers of open we've interventional broader begin that what didn't body administration monitoring and need to do sorts physiological perhaps of that the many the in and comfortable identified centered patient one prescribing level pre-prescribing. where the possibly another Phase appropriate the while will help actual largely assessments types -- location. We in certification prescribing liability generate of psychiatry for specialized medical medication or see administered session with that will providers. There can that safety seen physiological is be many believe able the actual for health than much will as of cases the and centers. around of can medicine of in even to not were the possibility the populations, who up be imagine, data affiliated any significantly possibly places might ultimate everything may we we're safely even do

options who very potential be be could for the who of session range could a the monitors. So much and considering potential prescribers

Robert Barrow

what Elemer, where generate, is be I'll one top the administered actually on SRIs we're primary just that's practice of change, way we observers think add again have response because of but to new to that fully repeatedly only having to right? When in can for with I and impact well, can really, today things of also of talking treatment it sort think And world, that the practices a start of doled of easy both care. really the market meaningful reshape patient at a to the scale tools It's level is we're because to transformational medical about start done. durability level on say, ability the we able the patients. these we're and magnitude at about a of live -- first of that tools and comment is then just of I'm fact they're the opportunity to here are and going practitioners, toolbox we out the appreciated a sure is often primarily which the make want to the one that, potential only at

view larger doing constrained of because this to opening years last relegated eligible. We potential on it before can go as the or a no that a such treatment psychiatrist and have so need of to impact. for they how view very larger to meaningful believe up where for a opportunity isn't of a here one line a that And can X much need for have there's they're see that a a we much too opportunity access

Elemer Piros

one this to aspect. a or drugs And have add Yes. do sure of the spent with don't May we? other manage titrating We time that psychiatrist one? MM-XXX, managed with lot side issue another replacing just I'm a a or those I specialist, effects

Daniel Karlin

exactly That's right.

Robert Barrow

expected say SRI, is as of said, of and weeks that a the there's we before one patient walks fact -- is in patient That of Dan mentioned, the psychiatrist. in to benefit. rapidity obviously, by over both we're take high the when clinical be is such that going relative of I we effect, that clinical talk those to hear driven with the a terms to results to drug Elemer, excitement mean, number able the going door given around achieve. are a over durability [indiscernible] practicing with a and it's I'll that degree and And remission things drug an the you again

of we the Now that over already the time drug the effects side see is events, when occurring. adverse

study a in we're remission. what of months within that seem far, rapid the to patient part, such later in follow-up couple so they achieve in is at a to they of where a our least remission, stay largely is going response large if seeing Here, indicative is days be

very clarity in clinical is something is to that our data. treatment that And we and early desirability from see high excited of so something that the in are kind course providers

Elemer Piros

the mention But to you the headache, forgot morning. Yes. next

Robert Barrow

the worse for that are Well, of you next things you morning. give headaches that there's lots

we physiological feel with profile. So very comfortable the

Operator

Company. from Next Patrick Wainwright question from comes Trucchio H.C. &

Patrick Trucchio

of follow-up couple a questions. have I

epidemiological APA. the at new presented The data on first is

Just for on for this that helpful in itself be X widely more data in or this separately, research? of of outcomes some UHB part health data then as economic there's potential can is Or can upcoming. or this of if potential the real-world validated of is setting having upon you screening other health about terms just if use impact the in as care wondering prospects GAD of MM-XXX MM-XXX? And tool GAD. I'm could it the some possibility the potential commercialization of launch deployed talk commercialization? Secondly, be built part beneficial there

in wondering, read-through first, treatment that study. program was positive and MM-XXX assuming from give and potential you data findings or and helpful durability that could trial a from I read-through regarding SaMD can about way the you for MM-XXX talk the how steps psychiatry potential Phase an Phase the Phase you? And study maybe of not cytibiological I what ASD UHB whether can presented and the the program regarding from with So MM-XXX, if should being your be us to we could UHP regarding then outcome you expect about idea to III of your II impact separately, think FDA next data discussions

Robert Barrow

try I'll by one. one these to take Yes.

fact in several in terms than that the about been is we're The much, we prevalence, suggests just last fact we're actually data larger what implementation of the not tip pick epidemiological that, today years. underdiagnosis that the to to really been has of yet can, market statistics up terms be certainly, So fully now believe, being and that in implemented, of is us is we've the GAD seeing the in there although the of a that recommended or current much iceberg. the GAD, The seeing is is tool for diagnosed. talking validly

the huge level. But proposition clinical are the opportunity, or and of scale hear -- [indiscernible] absolutely impact with the economics products. here. scope working of our societal the that see what we optenological a market of course, expecting can on based And demonstrate who are to does aligned to on that we broad current from to ultimately a stakeholders of be we value from and that uptake research impact health need going all aligns means has the to key we're to actively be And margin data. may that from health obviously to the magnitude quantify enable market certainly that the that and it a So the hear practitioners

is and to who regimen, have are this of a with first. we really we years, X patients. as past [indiscernible] lysergide, that months lysergide the and back follow-up we engaged those dose something further really out of but the data had that. Potential Certainly, over even demonstrated actively study, in a on the or study. patients different group talented got now UHP treatment working we after So initially about LSD look on that have -- couple durable the for read-through effects And

regression results -- flat of So achieve, back on we've over terms didn't that HAM-A conceived the we've to to were a lining see sort as baseline also scores, or worsening average able of we II of in we a time. where symptoms Phase largely seen

And effects effects seeing granted so are those smaller if ultimately for investing shown months that are in we to these but initiated are studies, be durable many longer.

continue the tolerability for again, to encouraging talked within later of and healthy research. But volunteer and our and be be profile when Phase won't will sort Phase read observe [indiscernible] design want and of hard from study. some demonstration it mechanisms to it's what of like XXX I to I Phase into report out data the activity volunteer overextend us going think through the something in into certainly of healthy underlying potential planned into the MM-XXX, to course, bodes the population the the we'll a I difficult have -- disordered of go from terms understanding very a population results of MM-XXX, be program. ] of informative we to have interpretation think milligrams we as certainly, we'll forward we in the of of II of III. And XX within longer able open-label But doses for terms of that's with don't about it's we similarly, one for we'll [indiscernible] as be able -- [ to demonstrate that well study the a

Operator

today's our does you. conclude your conference. in our this for Thank you at session. This further conclude I program. question-and-answer participation time. questions Thank That no am showing does

You disconnect. may now

Mind Medicine (MNMD) 8 May 242024 Q1 Earnings call transcript