MNMD - Earnings call transcript Q2 2024 | Mind Medicine (MindMed) Inc.

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Operator

Good morning, and welcome to the Mind Medicine Second Quarter 2024 Financial Results and Corporate Update Conference Call. [Operator Instructions] This call is being webcast live on the Investors and Media section of MindMed's website at mindmed.com and a recording will be available after the call.

I would now like to introduce Rob Barrow, CEO of MindMed. Please go ahead.

Robert Barrow

Thank you, and good morning, everyone. quarter results second conference corporate our call. to XXXX and financial update Welcome

be R&D the by last or share of MDD, further our for highlights with which the we the into Guiding sharing Today, will announced Additionally, GAD, MMXXX from are program Generalized expansion about progress to I'm made for disorder, or III the we've second with Phase major supported plans financing our in and both week. we significant along excited of further specifics program depressive disorder quarter,

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

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

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

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

on Slide tablet, begin in and Let me and Chief disintegrating by our with start R&D then taking oral XXXX ODT, discuss Medical MDD. update Karlin, Officer, to I'll QX X. MMXXX for Dan or plans our Dr. GAD today's agenda through will join our you business

also University We and Robison, III views program principal and of his Phase an by are Dr. at be on research our faculty to MMXXX our investigator, the investigator Robison senior Dr. pleased adjunct provide joined Reid Utah. clinical ] [ in Cedar is trials. will clinical development

quarter our discuss Dr. highlights. I'll Following Robison, financial second

milestones, where answer with then upcoming are to be our Q&A Chief Lilienthal, Officer, your conclude anticipated we'll a also Commercial session, joined questions. and Dr. Here we by will Francois

the we I'm II a X, to Phase supports Administration, our and completed trials the which advancement the for GAD. the meeting, year. the of successfully progress quarter half pleased of MMXXX first In Phase clinical Slide III share for June, into Food pivotal end constructive U.S. On for Drug of and

a major MMXXX second GAD marks in development of on Phase milestone to are initiate trial first We ODT XXXX, our in III our program. the half for which track

XXXX. in our study, Emerge share and of initiation for which MMXXX a the registrational initiated our We trial plans MMXXX first excited ODT R&D expect the MDD with half for with to we you are program the be also to to clinical into expand MDD of

our in sequencing with to beyond design cash and The we timing MMXXX at additional to study our operations in into MDD XXXX. and to be XX maintaining expect Emerge readout for is study while and second program will least a represented of a support GAD. informed this scope With for a balance and our regulatory believe to carefully III cash study by sufficient the the exciting runway also MDD opportunity months clinical executed approach, by We be discussions. first conduct runway registrational being Phase MDD,

and the Trademark a commercialization. our announced XXXX, runway for MMXXX MMXXX further U.S. patent intellectual new we in June, that Office property In ODT and covering issued protection ODT through extends Patent manufacturing for providing the methods potential formulation

have We the progress second [ MM-XXX, lead continued seen ]. (R(-)-MDMA) also proprietary which our form with is program, of our MM-XXX

are dose tolerability, Phase healthy a currently to We ascending pharmacodynamics. in intended characterize evaluating single and MM-XXX I in pharmacokinetics trial adults,

of trial repeated signs of and results exploration will trials of the spectrum the MM-XXX disorder the characterize in expect enable population. from further efficacy the this of daily We clinical early to doses effects autism

a this our of and addition and from our XX as cash our into offering, in transaction in underwritten cash months proceeds XXXX, we fees XX, our extends III plans, $XX believe raising report GAD. proceeds just other and clinical in that the cash to in to we successful readout pleased Phase approximately offering-related least gross public beyond current June equivalents operating million that XXXX, offering, I'm expenses. on completed deducting Lastly, before Based at first runway

and this continued Importantly, enthusiasm in allows programs advance strategy us our both demonstrates and MMXXX and MDD. GAD rapidly towards to the funding

is look stage trials Phase our pipeline MMXXX Here MDD. III X, our including Slide for at a GAD in programs, on clinical of and three

MMXXX our initiate mentioned, I second in half program registrational in we remain And MDD the XXXX. the announced first track of a newly to pivotal first in study intend to Phase GAD on XXXX. in As III initiate half of for we program the

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option, it both in which and targeting in psychiatry. differentiating of position opportunities We options believe two market offer MDD the biggest treatment could MMXXX GAD compelling could that if best-in-class become approved, a patients to

the with end X MMXXX our quarters, II three programs GAD and study initiation overall the treatments a of in GAD MDD. Voyage and Phase for anticipate MDD become MDD Slide the and program including health studies address novel completed studies pivotal and Emerge milestone our coming constructive brain truly as outlines MindMed and The Panorama meeting GAD FDA. developing major for we study of feedback incorporates In strive initiating to registrational in a to which the recently for across from MMXXX leader disorders. in represents we

to have study, over some Dan our turning call a Before to the our I designs to and to address take the minute over want go to of of approach details Phase the III decision Committee major topics from FDA come Lyko year that this FDA's therapy the recent pharmacologic in assistant MDMA Drug for earlier application herapeutics and on PTSD. focus Advisory since meeting

researchers, Our is ] believe and by development be regulators, participants. X [ will for thoughtful prescribers. this We on to patients and rigorous continues ultimately and strategy appreciated outlined confidence and clinicians research Slide to translate

have psychotherapeutic number, perhaps and to this use most of address implemented considerations importantly, elimination drug visit in of both intervention of strategies blinding blinded assignment inclusion several Specifically, key central and trials. questionnaires expectancy class treatment to the and methodological our we clinical raters the in including the

characterize our trials, we practices and industry follows the monitoring clinical clinical safety to well-established through to approach intend fully the our both and safety robustly pharmacology MMXXX. best III Phase trials Additionally, of dedicated and

data, has designed the efficacy in with MMXXX compelling adhere that and and development FDA Phase demonstrated tolerability well-designed to today's of Our carefully standards guidance. MMXXX IIb ethical believe of been trial standard in GAD which care. clinical to highest We alignment our for exceeds

with robustness our MDD evidence growing backed patients need we Additionally, scientific to along clinical potential from for of emerging other body continue product the unmet treat our best-in-class suffering to publish increasing as candidate, and data disorders. by brain research, an house GAD, and MMXXX's the of

excited As for which both continue we they MMXXX, class. pivotal drug statements exemplified public psychedelic for FDA's FDA's to they development both that our further to remain treatments. has and research drug encourage on indicated advance and the in will programs through psychedelic by commitment we that This recent innovation research been development embark appreciative

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

Karlin, turn detail. discuss Dan? our over in development Dan to Medical like programs Chief Officer, the clinical call to I'd to Dr. Now our

Daniel Karlin

Thank Rob. you,

Slide severity the XX address impression to has results highly to the on of our based shared with large in global onset participant's disorders in XX. hours XXX health GAD. brain We with we Phase treat point X.X than which was X.XXXX. rapid in potential with believe compelling for or from clinical MMXXX a less observed p-value this a major statistically MMXXX CGIS, unmet Turning point trial, a trial needs significant micrograms, reduction we in effect II in In

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Phase for results support III highlighting stand-alone GAD. in with as the treament were therapy, these achieved for outcomes MMXXX additional potential no Finally, a GAD. program our These

development plan III MMXXX GAD XX. for on now our and I'll Phase discuss Slide

be June, Voyage placebo. As FDA, two Each in the and of constructive placebo-controlled a This and will MMXXX. II for and study safety on a to the parts. provide efficacy be collaboratively double-blind, open-label, XX-week MMXXX meeting extension group two durability parallel potential consist pivotal of the study program consist Phase Phase the retreatment completed important of ODT of trials. on long-term B with will data reaching an mentioned, clinical study Panorama profile will will A alignment versus trials of study. Part Rob randomized, designed we pivotal trial III highly trial assessing end Part each our XX-week

enroll or our to who ODT enroll participants In discussions to clinical who Phase to III and across approximately regulatory XX approximately guidance be to receive date, to micrograms program X randomized complementary blending. address X FDA ODT to Voyage functional and MMXXX XXX placebo. II is study with Panorama studies our issues as placebo. XXX randomized receive accordance to and micrograms key will participants MMXXX to and be XXX continues such will or MMXXX designs then anticipated X:X X micrograms is anticipated for MMXXX ODT utilize to methodological our XXX

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over Voyage and both While to improvement X-point we X-point at Panorama have XX% certain a to in assumptions. previously for placebo have detect XX on placebo power observed based almost improvement designed week over statistical MMXXX been

design in our to statistical use an Additionally, sample maintaining XX% and variability which blinded of sample for up the in adjust adaptive in an size of allows in both study. for us each goal parameters studies, power allows size This re-estimation, we approach the an interpretability with results. will increase interim enhancing nuisance to with

greater. exclusion and our HAM-A a Key XX studies Phase in will both trial aged elements of IIb Phase GAD inclusion III to at recruit as and largely with of diagnosis adults the score will such criteria GAD successful or mirror XX XX

studies, micrograms HAM-A clinician-administered their retreatment B. through of outcomes, with will patients III ODT, During reaches or the Part XXX HAM-As MMXXX investigators scales. closely using Participants be patient [indiscernible] with eligible higher X XX Part B and up electronic to will Phase available reported monitor central treatments for if

retreatment long-term or for allows Part response an include outcomes Importantly, the safety. would the of from retreatment to need the inefficacy. effect, and time the and assessment B Key treatment design to durability of

data response repeated treatments to be dynamics This retreatment. on of We information GAD understanding ODT in patients. assess will treatments, MMXXX longer-term also and treatment valuable the per will year safety in average

Phase outcome hours and to be to of Voyage being our with Phase with to in the XX a the observed week Phase are in we designed hours. durability II, the with both HAM-A measure consistent baseline III our is duration have Phase Based data consistent on II. successful trial, the X to we a in agreed also minimum changed treatment with collected primary reduction IIb session the which primary using endpoint of Overall, from including programs as XX, we from FDA Panorama

program and our operationally advantageous settings. practicality in real-world in is enhances MMXXX's This research

monitoring structured to criteria resolution times data require continue on the drug safe the parameters could timing collect for will appropriate intentionally course using ending and We designed effects determine that and time sessions monitoring. of for determining to

track We III Phase are remain we happy year. and GAD Voyage this trial to expect in to on our say first that initiate

to Slide Turning XX.

and given less encouraging than point that X.X study As announce over These AD expansion placebo, a into statistically wasn't of with program, which Data MADRS we a the are Rob R&D study to Phase also from earlier, value MMXXX lower major excited which II led powered appeared scores our a stated MDD. MDD to endpoint were the decision pursue results to as MMXXX. for episode, to significant in we patients are was our XXX-microgram of Montgomery advantage an baseline potential or dose response deal observed an effect demonstrated Åsberg XX.X% we effects. a on for depression represented MMXXX, to baseline ratings create particularly p the than X.XX. from additional This this experiencing in expect MADRS XX. indication given [indiscernible] the score group, depressive that In antidepressant the our the would ceiling

program will pivotal two for which expect Slide trials. of XX clinical represents development the Phase and III MMXXX MDD, consist we

our treatment Part and the a extension is a parallel the Our Part of XX-week study, Emerge placebo-controlled randomized, pivotal B, like MMXXX certain study of to open-label MMXXX be participants be XX-week which conditions eligibility. single double-blind, A, which which in And dose will study, GAD for during versus trial, group will ODT, placebo. of retreatment with two ODT first parts. efficacy X for assessing safety subject eligible trials comprised a is

the between or MMXXX in participants Emerge X:X micrograms endpoint is Emerge ODT from to score The XXX at XXX in primary micrograms MADRS anticipated at be baseline receive least to MMXXX X change in enroll ODT randomized XXX placebo. placebo. will week

informed to conduct and in in expect regulatory design trial the a the study MDD Emerge by second be future to registrational We with additional the and discussions. timing

our this mentioned With on Rob trials. his the our of programs execution diligence. MDD Robison, MMXXX earlier, Phase will to As and happy our with continued two I opportunity pivotal introduce that, in exciting across program III perspective planned who operational Dr. balance Reid am provide financial will

Reid Robison

they development just seen rapid about I'm impressive. GAB the I've programs I've very in results Phase truly results the as of the a stand program, after so significant development with far shared, from make sustained MindMed's the MMXXX to excited exhibiting psychiatry. single dose. and efficacy, MMXXX field impact Phase III weeks a With been you that thrilled I are believe robust IIb XX personally

Phase in Equally trial MADRS comorbid XX score from to GAD improvement showing participants IIb change impressive baseline the symptoms. in in depressive the week is

of beacon conditions impacting of quality life. GAD, For debilitating including severely offer people I've how a firsthand seen trials both from depression, suffering hope. with are comorbid these And

short current bring market important we stand patients' the options. physician meeting it to things want standards needs, to with that of are effective programs and I about develop perspective that Given development that III and share that The an today. our from treatment you of is vital new Phase care investigator out falling

III efficient. First, the programs Phase are operationally

of degree and our in to similar they And ability design, suggesting III a third, possible. Second, read-through recruit the II Phase trials high are enhance patients. as

more will attributes seamless. down of I'll of break make All our these further. three this execution trials all

example trials as operational make the my scientific team operational is both would patients efficient GAD to to X more session III MMXXX practically run. them of manage it XX allows reducing making MMXXX rigor. approved. key is this, treat hours an ease while design maintaining of how From an perspective, of to monitoring from mirroring feasible the Phase the expect delivery effectively, I to treatment elements This In crucial trials, is programs if

is advantage and to significant trials these Another recruit ability of patients. our efficiently enroll

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

trial trials of data, the us ability to enables safety high MindMed's continuity Lastly, This builds GAD to findings prior of efficacy enhancing the on MMXXX results. design and these consistency. existing build of directly Phase and on IIb validate ODT a with the degree

physicians addition, which I trials patients. in these In Phase the is primary III the evidence to on provide utmost should XX-week looking important for endpoint to started. trials forward durability, Phase III I'm GAD and believe getting

I'm results treating a to and with MMXXX the significant lives. pave forward meaningful And and eager can the potential patients' They GAD way on the move MindMed the of to in for impact MDD. advancements see development of have make

And with back the I'll call Rob. that, over to turn

Robert Barrow

and Robison. Slide I'll to like programs the to We're aligned XXXX, pivotal Thank ended XX. financial to which on Dr. you. get you, June for are be grateful excited started our now XX, our on quarter results highlighted with turn clinicians

of into extend R&D GAD. III operating Phase our expect our had line and of will the cash current XXXX, compared XXXX, equivalents the plan XXXX. We $XXX.X million anticipated data at XX, to closed June to As in believe months on XXXX. Based beyond runway our milestones, from be XX, as June and as first in equivalents fund recently for and XX, sufficient financing, of million to proceeds our cash December $XX.X the cash company least this with our trial combined we readout top operations that XX totaling cash MMXXX cash

and period same same ended XX, representing period months ended cash For of $XX.X to activities $XX.X $XX.X in the quarter million million $XX.X the Research operating XX, XXXX, million compared for the used and decrease a expenses million were was X million. in to June in XXXX, XXXX. net the $X.X XXXX, development for June We for compared

The by increase a million decrease MM-XXX of of partially of $X.X GAD development an of costs and is result increase of in $X expenses and million $X.X expenses offset in increasing $X our related research related in internal a an expenses as million personnel decrease preclinical program. capacity and our in primarily to due MMXXX decreases million to activities to program to related

and administrative this in was compared R&D XXXX, by period GAD XX, decrease XXXX, decrease June ramp we same XXXX of and Shareholders. running. increased partially the half million contest Meeting the We the million III professional as ended of for General and expense. XXXX studies compensation Phase MDD and to the get million. in anticipate $XX.X in second XXXX, services in General fees expenses do $X.X up The during in up a months to year quarter relating the expenses offset proxy to $X.X attributable primarily ended June were and expenses our to connection with the stock-based X of Annual for XX,

warrants net XXXX. time XX. to quarter exciting for loss XX, million years, you compared U.S. the company's for same an for many period $XX.X can with on million as us highlighted June The was fair The XXXX key the up is changes in value MindMed at next dollar of to the was ended decrease primarily due over financing Slide the of of This XXXX, $X.X million. $XX in coming couple see catalysts

GAD our anticipate half first In half III in Voyage trial second of III first XXXX. We in trial our in the initiating Panorama, GAD XXXX. of the in Phase Phase second

to the clinical the Part Voyage MDD patients in bring Phase represent of We in first We're pivotal for treatment company of for and and Emerge anticipated line our half III with starting closer MDD. projecting GAD to points trials XXXX milestones Emerge, top and the potentially readout these in our half first differentiated first initiate trial of options novel A expect and inflection second These significant providing XXXX. value and Panorama highly with us could half then in XXXX. for also

to mechanism the for an scientific action of We believe potential compared care. date and of shows of today's to MMXXX that validates on product emerging the evidence generated best-in-class MMXXX's profile standards our understanding

in forward strong our positioned moving We both the readout, months programs pipeline first strategy. into Phase excited our our loss IT execute cusp and protection cash to XX of a be advance runway strategies, with and to pivotal beyond on with on MDD we well our to development are are XXXX III GAD and for and and MMXXX

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

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

And the happy any and questions. take I to team are

Operator

[Operator first Charles Instructions] Our question from with of Cantor. Duncan comes line the

Elaine S. Kim

the is This the agreed hours care to Elaine requirements the and patients is in response dose This Kim duration treatment rates question, having this the following implemented? treatment XXX-microgram to XX is what from to a be X-quarter, on by for open-label And remission my for what FDA X-hour continue session, for follow-up? session patient of information requirements Is question. dose first what reduction the the or hours, will help XX-week be enabled second for decision driven versus X XX-microgram Charles. maintain

Robert Barrow

treatment here. blinded of open-label because in remained until in study, receive extension is anything a an the it's received status B two Yes. are patients portion Thanks received think B opportunities actually label of worth the patients the with first so actually which open-label the extension part has question, haven't program, part -- so the while Part say, the designing when B study the until things they I that about the should thoughtful the unusual study on treatment Elaine. phase of -- about we someone how much, study, with actually pointing I for be analyze and drug, extension we're think would open-label versus To study that continuing Phase out really III of they open

suggests selection It daily the the go-forward relying the certainly micrograms because modeling [indiscernible] extension We Phase it analysis is dose is interest, mask concept The of is wouldn't Phase take our of XX-microgram to model of results of forward that whereas the and dose clinical IIb functional dose the be be the addressing control to is the there our in dose conducted results. believe simply dose and from case there the our XXX we medicine. an of efficacious the in a should rationale. as on is additional aid dose, we MCP studying IIb is XXX-microgram a functional unblinding. it That's

We're not or to the who phase or is be the have in setting time. efficacy we're study. upon for interested in at real-world-like reemergence to of the happens more take what opportunity the submitted after patients in not XX-micogram, continued or a The the this retreatment dose to characterize clinical the forward initial

data. presented second Part we question, of your or part the your question

committee this this been So advisory I from know has point of early since on. a very year. discussion earlier the

have very Phase when we of for went extreme been to the conservatism their intoxication. be structured and allowed in session. criteria used hallucinogen I, -- DSM-X We definition monitoring patients end would to intentional the about designing

cleared intoxication. to signs be So by meeting of patients no effectively had hallucinogen

be we session. [indiscernible] dosing of representative RINs informed and a the modeled real-world continued more by [ regulatory thinking like a discussions that is data, checklist our As after much we've evolved refine been expect be checklist to to our for around ] further what we have would and

our when Phase a collected sort present time duration monitoring the III, monitoring FDA we early exactly we'll the as part use session the is in go be course a for than the Dan duration Phase again dosing as that of data, those also argument we'll even the able dosing of able presented be would that characterize to And of will departure session those a make be so the to study minimum in as but the forward we to to -- IIb hours, required patients be we shorter starting and mentioned and curve data So III of monitoring our that readiness required appropriate. to clinical assessing temporal from of that in five Phase of earlier response is characterize here. assessments be X

But that's of real-world think we required at monitoring ultimate discretion one we be able be believe the be spectrum, RMs far the if physician there ], setting should when should there goal, tail that [ in labeling period and a about employed. left in the to the is a

And so in hand arguments minimizing the is data interest that of required that to have we fixed that make build duration us is the around to to monitoring base continuing something structured we're a ensure of data-informed to to agency.

Operator

helpful. very That's

Our next question comes with RBC Capital Abrahams Markets. from the line of Brian

Brian Abrahams

-- prior all questions you on detail will the can really appreciate think me. is filing retreated a that following. be proportion beyond And the durability that guess, the for need off, I and demonstrate GAD. Is designs. Two degree to elaborate going there weeks be XX first and patients on and/or you required to bar you approval need of then who will a trial certain in and potential from to of follow-up retreatment the data had that a

Robert Barrow

Thanks Brian. much, so Yes.

instance, expectation issues we because studies, no the treatment got limited full to a that patients our for weeks. rerun single in of extent beyond we anxiety intervention, if is So period are with on randomized severe placebo background of XX we pragmatic after in ethical keep

So we of long run we do group study. can controlled sort how into randomized on parallel limitation a

extension a and XX-week about the that study of guidance the -- that establish to ] be in the we to endo focused would single phase durability characteristics XX-week most of of that that important good terms those discussion labeling, and initial alignment talks but FDA's to We a on of treatment. primary after duration. in use And agency, Phase because even the study application, certainly had response. the the around dynamics the durability to [ informative a with aligned XX-week endpoint would being duration in we've primary II believe data that, demonstrate believe we of we in in are really outcome So demonstrate inform the our of endpoint meeting are sufficient that response retreatment reached our around

Brian Abrahams

XX how those Okay. micrograms about then a demonstrate trend? it. between regulatory dose two to separation to between Got need you a XXX to address need functional and you And dependence questions unblinding, much arms or show statistical just the will in potential order

Robert Barrow

question This the extensively we a and is great with -- about our both Phase have agency. program and thought interesting internally really Yes. discussed design that we III one extensively a as and

as not our Our to view of response. is the which there was establish Phase a Phase a significance. study, designed analysis control primary the did II is simply statistical was It control. degree is we statistical with study us. of a to II high dose that the That interest intentionally XX-microgram

part dose we of with minimum we outcomes MCP analysis, is clinically what come the effective pursuing. we're of clinical believe the kind to away As characterization mod achieve of

high a only That, the of doses that reality II but unmasking degree high our coupled clinical in we functional with doses a study, response. achieved saw Phase drug, of two all active that or the unblinding across

like an response. studies. good and expectancy, in to They're between blinding and Our dose degree lot I of are the to dose field bias do. not there confusion, methodological about that the belief any a expectancy about And to things control try functional group other are XXX-microgram to similarities is in been a confound think, these differences patient include what confusion the and there's there is there intermediate there's go-forward been that of dose reestablish the the groups we

happen, may something comes the to that if we'll overlaps during that feel of to that with dose dose that Our they a is studies be receiving micrograms into patients XX perceptual dose they a but would its session, view drug to of in been dose XXX-microgram in clinical is interest has that shown enroll be of similar effect, previous study be when may into active if trials -- terms if the patients a a only such drug" a the dose the that to or coming of that not active. clinically will here they is "the treatment develop they a effects trying be of story patient obviously a able receiving degree study, feel in expectancy inform they patients that expect with because clinical were effect a is with ultimately

knowledge after will drug, the expectancy micrograms the or so the as feelings And fundamentally it drug. placebo, patient micrograms, of psychiatry. that mitigate new be of of often effect have of that mechanism the is a dose, reality buy the feeling we're the we And XXX The of is receives to the drug a they believe whether case XX the it. in is the trying that very

statistically analyze intend And do is or so dose. XX-microgram we believe necessary to the not

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

Operator

Partners. Leerink with of the from line Lee next Our Rudy comes question

Unknown Analyst

Congrats on the progress.

the still III confirm IIb Regarding did of to that means be just pivotal you you the the pathway question. with quickly, Phase regulatory trials trials? the used in FDA file Or Brian's do GAD, both NDA? And to as one follow-up can a Phase

second XX-week rate-limiting starting will label of in Phase the step first the III the trial? for year, GAD filing be considering With the of what half the retention

Daniel Karlin

Thanks.

which pathway, study. and Panorama two not is conducted the study Phase intend We pivotal Voyage In that regulatory of planned, we a IIb are with Phase III file to the studies. terms studies,

Robert Barrow

we of this the away there's Always MDA required a or decisions the of our demonstrate is rate come the the for studies of high of be the Phase limiting, well-controlled going many a terms But belief at of meeting. final staging A II pre-MDA stage discussions that Secondly, with and two with an in alignment. Voyage of of to about is completion what studies the that demonstrate drug. the limiting rate Part is that caveat for have course, the efficacy reserve of to factor degree Panorama in

while be Part an believe that have study we have studies of ongoing Phase adequate informative that would we III the pharmacology submission. that enable And program, data to Part will process, a clinical cut we B our B be of in will from

Operator

comes François of Our from with Oppenheimer. Brisebois next line the question

Unknown Analyst

more or any to? that meeting. were been II the all during for of you for And Dan any thanks there on to have the Could the issues around meeting. want there the Anything surprises is the strategies whether some add that concerns meeting, little were of bit but raised that end the the especially color you've taken, This you going during Phase was guess related I about questions Lykos Frank. to on. considering a AdCom, talk

Robert Barrow

we the much events of year. this that Thanks regulatory Dan. in Yes. the question, In happened the I, so have for the got fortunate sequencing Phase

learn meeting integrate Lykos a with happenings So end confident. of and we're a from the field benefit to us allowed valued agency strategy the was after able Lykos greatly the we the we AdCom make we from us our into Phase had it II feedback sure public conversation something to the discussions great that Advisory be because thinking obviously thought other our and in and to really shortly Committee, very pursuing which to to it the we're

we with had discussion so a great the agency. And

in incredibly I of the to with around solve willingness tackle appreciative willingness issues engage be I away a And dialogue those a slow think came shared are we're degree think to alignment high a complex There's surprises. complex no the to issues. agency to their and of certainly we trying there development. down these in in doesn't that of conversations, pragmatic way terms

coming the a an or and allow argument that safety committee the the of meeting us or to peer-reviewed that view would whether or go observers and compelling the case proposition is have the and submission. the strong we for the any and have a advisory out narrative with then publications that agency to both We'll broader that plan at and to drug to over value efficacy we proceed commentators made be can to of be that Our both designed.

surprises. ClearPath a came very Forward. I constructive in with I So had dialogue would and we no that a say

Unknown Analyst

a as quick functional just the a issue? after And demonstrating generally FDA just with blinding Great. we a Does follow-up, the going approach XX-microgram address the XXX-microgram. -- buy or agree that's expectance dose dose and relationship that relationship being

Robert Barrow

your I I think question. understood

strategy, and certainly we the Phase So forward confident view our Phase and in and our address III the we logic path in in II to meeting issues. plans these protocols, our we're our presented and and our

is I to this expectancy the it's and that really think for mean reality psychiatry highlight is on of look. patients X very that while historical been important issue have the functionally shown even milligrams of to unblinded a common functional question sort -- only a it's XX% able research, unblinding. incidence asked particularly work, actually Xenex of of of fully is SRIs matter is drugs psychiatry, that studies on to spotlight correctly disorder. on under and guess or of they're X% being in SRI, historical based for a there's something how This SRIs anxiety us the appeared like to

required and a line improvement agency establish while unblinding, of we not the expectancy is safety in many, questions evidence our placebo. is the that, scrutinized statistically the being should clinically unusual to to many that have on well-established and efficacy include aspects demonstrating with mitigate and program So around our designed this forward. over believe that we follow try functional what the while we the around. for drugs, is and we it's address That's path believe And to which significant in field, we precedents and

all couple just last even this is about is months. over Again, though highly that something not of talked the of it's been new that

Operator

of Our next with the Beatty Baird. line Joel RW from comes question

Unknown Analyst

Christopher is Chen on Joel. This for

In terms started analyzing domestic of U.S. you opportunities? the so, XXX, but is how ex you primary And your analysis? focus if all characterize that have at I would know market,

Robert Barrow

Christopher. much, Thanks Yes.

markets, certainly to sales at about on and commercialization dialogue those markets, engage opportunities, force ex started focus develop makes and not, launch open and have We to would be we markets. the this intend the our about and collaborations time, we're ex-U.S. sense those to partnerships analyze drug a it ex some engaging in do or most in U.S. certainly U.S. discussing on when markets U.S.

in our return launching investment on obviously, the U.S. and for dynamics But Europe be launching in we considerations than the a there lower and focus of, a drug think on pricing drug various would the instance, primarily. the

Operator

the from Canaccord Sumant comes question LLC. with next Genuity of line Our Kulkarni

Sumant Kulkarni

of is therapy? purely is Do any of effect III prior your ensure criteria integrity treatments other you more targets in inclusion portions how trials? have psychedelic do MMXXX other your specific in open-label use sure or versus to studies, make LSD attributable durability or of the maintained any Phase And you for to that potential

Robert Barrow

one. Yes. turn Thanks I'll to Dan address to over that so much, Karlin that Sam.

Daniel Karlin

Yes.

Sumant. thanks, So

recent explicit use use prior heavy years, over to we For and exclusion have exposure, enrollment. of any second related criteria number preceding psychedelic a

currently beyond want sure specify and English don't an that heavy certainly exclusion we using users. that perspective, or while recent who we're we So to getting be from folks aren't

the general on population we're into II. usage use track we with the also in epidemiological used exactly we the population. we in to much Phase We III very criteria mirroring was, in almost was will about in of in III Phase XX% course. what inclusion which exclusion historical Phase essence, because found What And findings XX% ended a aligns with found history, with up moving interestingly enrolling, these Phase II

possible. the as do is continue we of population III. to So in population to we ever, a Phase we we in Phase and did as that II we'll overall in representative think that GAD want Phase that II, get do and

As on Rob blinded very far way that extension is phase as that the run. efficacy, we much in the same that going discussed attribution data integrity of to question, is really the phase and bit a be prior a expanded run

other be of of we that enforce those a psychotherapy are [indiscernible] of people same treatments, in the restrictions that before of new and treatment, continue trial. the to through out through and stable folks trial, for phase. we'll if extension therapy in has time entire background outside studies, outside to watch therapy period our And unchanging all the engaging So on the

pharmacological placebo treatment the receiving only they're that dosed extension folks receiving entire started phase treatment give through do treatment the first or we only a arm only in they opportunity expectation change new the while if So either get to is they're is for MMXXX. time or the that the and that a control the arm, that receiving the they're

Operator

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

Mind Medicine (MNMD) 13 Aug 242024 Q2 Earnings call transcript