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Cybin (CYBN)

Participants
Leah Gibson VP of IR
Doug Drysdale CEO
Aaron Bartlone COO
Mike Palfreyman Chief R&D Officer
Greg Cavers CFO
Eric So Co-Founder, Executive Chairman and President
Charles Duncan Cantor Fitzgerald
Sumant Kulkarni Canaccord
Patrick Trucchio H.C. Wainwright
Francois Brisebois Oppenheimer
Andrew Partheniou Stifel
Elemer Piros ROTH Capital Partners
Call transcript
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Operator

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to Cybin's Second Quarter Fiscal Year 2022 Earnings Call. At this time, all participants are in a listen-only mode.

Following the prepared remarks, we will conduct a question-and-answer session open to financial analysts. Instructions will be provided at that time for you to queue up for your questions. to today, that XXXX Monday, p.m. like is conference at also recorded being November would remind this everyone call X:XX I the XX, Time. Eastern I Cybin's over Relations, will Gibson. the of Leah President Investor to now turn Vice call Ms. Gibson, please go ahead.

Leah Gibson

R&D to Nadia, Investor of conference of call. second you Doug Officer Cybin. for With Leah Thank today's Cybin's Vice Drysdale, call our Executive we President, is Palfreyman; Officer will is Q&A Chief Gibson, also remarks. Aaron quarter Cybin and welcome and President Co-Founder, Relations Eric This and Doug's me the Mike on Chief by Greg Chairman COO, and joined for Cavers session CFO, following Bartlone; be Executive So

call started like statements statements. are I obtained would company Cybin by the get perspective that forward-looking from that to statements we will are and certain materially were results nature, assumptions today, and forward-looking to on those these relating there and preparing risks differ our the everyone Before by today's made in several remind statements company made actual

As that statement you potential guarantee on and to and materialize to refers information any cautioned forward-looking of its Cybin and the sections discussion analysis a the available@sedar.com not them. will undue are company place investors forward-looking current management's edgar@sec.gov. reliance result, on cannot and

statement, turn securities Doug. forward-looking statements With that, Cybin any does otherwise. of expectations over for any the information, as November by to future as call to is of represent new update required laws, or Cybin's that not Forward-looking XX, a I'll XXXX. which events Except obligation result undertake but

Doug Drysdale

on XX health rapid has around has call effective greater. for and we're you we're the for scientific the transform today. us. to - been And a has Thanks mental The The for therapeutics. Leah. need health Cybin, psychedelics At crisis mental afternoon, everyone. of exacerbated accomplishments been The safe joining to our our a pandemic and share Good business mission into thrilled today. And treatments progress you exploration period with update never months past world. thank

and We industry To have push so achieve to to therapeutics and comprised improve we scientists, that world-class external those researching we are psychedelic together, assembled dedicated partners the boundaries. developing, treatments a of who leaders, all for team suffer. this, transformative can

We and with about are commercially already goal taking what know psychedelics all classical need. engineering we for those therapeutics safe, creating and in effective viable them of the

have focused I evolved platforms, I'll our more continue in We few have regimens formulation health on our industry, and are detail delivery treatment and the these describe evolve since because systems, for mean mental proprietary company to we engineering, moments. drug leading approaches, this, in a disorders. novel By ecosystem. into we founding drug discovery a psychedelic in entire innovative

ecosystem always out intentionally the an we XX built with Over months, have in optimize past therapy, mind. patients psilocybin to

We support and scientific exploration push are the working to create hard the an infrastructure boundaries. to

This is portfolio property on and Let portfolio we differentiator anticipate add me three in patent to our patent patent our to company a recent a of the continue and major compounds our XX filings XXXX. touch families. we expanded have To-date, have over of developed XX we intellectual will achievements. to novel across for some that

significant advantages with CYBXXX and preclinical our drug clinical key over have progress advancement bioavailability we Additionally, in supporting completed studies partners. the dosing psychedelic preparation showing made classical XX, of and development, CYBXXX with toward molecules

expected studies early to to are approvals. in XXXX, of First human subject necessary all in receivable begin

have and the now established in and organizations. this Partnerships Stock are and accomplishing goals to are year, partnerships critical world-class employees research also we have first such XX presence our in Exchange. fact York New extremely As Canada, are U.S., XX to we only a five grown the we company, the with and clinical from the be in and sector a of U.K. to advisors and the have listed we scientists company on and Ireland that past proud

a first of manufacturing allow granted hemodynamics device. recently, ketamine study U.S. its to kind our technology, this license may our for hope allowing Just a I activity authorization wearable using on received Enforcement Kernel's to Lab, for headgear FDA neuroimaging development of quantitative Flow our internal sponsored us brain And effect Boston for Schedule recently, the Area Research We Drug brain expand Agency a capabilities. research that us and feasibility evaluate we psychedelic during experience. Kernel quantification using more

collaboration psilocybin-assisted the psychotherapy. Psychedelic Facilitator preparation clinical Program in Washington for EMBARK of Training the with first the launched University also of in We trial

are the order also in recommend of have ill professionals. programs, our promising meaningful EMBARK And advances in to those making therapists - healthcare notably, helping and welcomed healthcare our Today, recently are We're this safe Relations. addresses for initiate of as preclinical developing has created approval Gibson Inamdar Cybin we to Amir We're CYBXXX. Development; many as awaiting like our in passionate Psychedelic The Geoff therapeutics Dr. Officer, both with whom Dr. to patients distress COVID-XX. COVID-XX-related as with to share And team final suffered Chief mental study effective health done we extraordinary about caring cosponsoring an these imminently. we Vice Leah Research and We advancing and patients. approaches in to President Varty workers and job for study tremendously Medical begin Head we gravely I'd with support lastly, of frontline disorders. the program Investor

especially believe million people some form of molecules, treatment health. Our as may shows the This data work by mental addiction nearly according XXX to eating depression, World comparative have urgent Health globally are reaching or preclinical wide over psychedelic today, is multiple affected we advantages the of Organization. disorder potential classical for implications which

affect indicate estimates XX% why up to disorders do. U.S. the and that's committed Some we're of to we population anxiety that so what

address day. add scientific and thus we important recent we In Phase II with into had to them. to profile therapeutics, regulatory of that itself, have programs, molecules our can a to identify order importantly molecule payers, useful receive and treatment providers, we no the these existing psilocybin. There patients. the is made improve aim far on every and practical Yet to that may our efficacy is progress academic potentially transform ultimately doubt continue with now to and the so challenges Turning improving protocols progress safety approval, therapeutics that study shown drug and development that have and most benefit studies to the of goal to

the to around our analog formulation XX for to the We the goal identify CYBXXX. have clinical had of proprietary is past three months, course into programs CYBXXX best approaches. CYBXXX third the The forward built psilocybin And lowest programs on take psilocybin and studies. working two at cost looked parallel is candidate at

other supplies. and so. would sublingual the a nature minutes, and long days, XX we resource lead to We psilocybin with experiencing plasma a We've work providers. improve film dissolving one, vast greater due All psilocybin time and designed include the of centered-around action. in high to the release. an great do scalability do prototype learned onset, the limitations the rate treatment, result than CYBXXX that slow variability in CYBXXX, have burdens believe formulation formulation achieve our while so hour and the the dispersion three clinic potential in and resulting unpredictable effects. we long these these often which and all still CYBXXX, hand But than we're meaning this through work fast of in to events a peak effects. just potential formulation a known to addressing extensive increased study on aiming case made more challenges oral improvement, a to duration profiles limited deal up on from CYBXXX. at Cybin release patients of duration eight-hour sublingual to side release in oral And the is for some And the of adverse the to a for patient issues; still is than time payers, patients psilocybin can resulting of means therapeutic. And In or a over levels, on Two, as better half patients the seconds, selected outcomes, three, profile. occurred the wait and was of

have with As designed many to overcome can analog with approaches outcomes, variability efficient our We for improved to levels, eventual duration of believe we where brings shorter optimize value investments strongest of properties some promising from species programs to pharmacokinetic safety following and to of a obligation which better conducted see, in FDA advancement with and most models with psilocybin psilocybin requirements to faster studies of and studying positive has we've us penetration. of deuterated clinical advance try achieving with taken only plasma to make psychedelic goal and capital. towards profiling, in use a including forward. our which, different most terms been of CYBXXX view, proprietary Cybin's patient of action, the and you in move we effect, CYBXXX better the action, use. perspective brain multiple patient the of development less that in onset delivering challenges shareholders to our the We the candidate

result for headaches, responses in are effects and events. three, and commonly psilocybin, reduced oral and brain main potential time has for effects, variability in the are efficacious and all, oral was nausea of and achieve And effects times benefits. This and cutting therapeutic all almost a CYBXXX, psilocybin all offer found result the scalability has potentially done the treatment more negative patient compared greater and dose approximately All in potential half. duration adverse two resulting patient with cut in the half, the psilocybin a predictable duration, this What and which for to total in of XX% of the been psilocybin, the and while aim serious to of less a days CYBXXX in CYBXXX therapeutic reduction dose. a designed that a with providers drug half safe such XX%, that potential of order to the retain to peripheral for human compared payers reduce oral predict potential to access for we due All patients, to three psilocybin. in clinic two, due to circulation, profile, in onset One, providing as penetration. was seen to to of both could safer with potential reduction as psychedelic side in

patients. combine and a Importantly, into AUD the alcohol patents. and and greatest to from for savings this see disorder has cost minutes to family a that protection itself use lends disorder efficiencies, few potential I patent with for an program the positive single to and opportunity depressive and MDD is deliver a believe That also nine of major as outcomes reasons shared file we ago, we

As highly the with we to partnerships necessary have steps program, procured through a next and CYBXXX capable, internal the external rapidly advance development. team built we have believe the scientific

be plan with or Manufacturing to and materials. respectively, and complete the expected expected quarter by quarter quarter Our regulatory full trials are the is IND leveraging quarter. following U.K., of EMBARK completing the one, early-phase U.S. program Drug to New clinical anticipate XXXX and Chemistry, the are made development, U.S. in that array filings Then XX in XXXX. and we production in Investigational Also preclinical subsequently CTA, of the U.K., or commence XXXX. MHRA our studies one, to two FDA Trial innovative clinical approvals Control including the psychotherapy or CMC Clinical of Application

being treatments safe, expectations CYBXXX, and and our oral and groundbreaking of potentially of We We supported attention believe improvements necessary in reported look yet our psychedelics advancements Conference last to progress. garnering out strongly to excited from the you I that are indicative on accessible believe our the industry research we effective passion approvals, as clinical in that's and The these Wonderland data can be underway. by is to it an first being and of are well conference keeping industry advance lot into we is prepared success therapeutics, promise achieved in psilocybin are these and subject to Miami well as The rightfully our findings, our of by the that and of we so came the we welcome the apprised patients. is psychedelic about are work psychedelics for need is even all to We one through we industry, receiving are industry potential week's CYBXXX peers. aware that a the made excited also more that as still all involve is of of that the look to phases, program on excited the to for CYBXXX. why very development into a forward confident about

September and Turning cash now XXXX, $XX.X of our totaled XX, to financials our as cash million. equivalents

you was base operating to Our pandemic. as the your health our I'm for quarter the and the disorders has for ended Thank can up the about all the of accomplished end. net of developing cash attention of on proud work the our expenses million in towards more address $XX.X Cybin continue Operator? for treatments ability that devastating we and benefit. an towards September experience XX, to line. And urgent from which time move safer, COVID-XX loss million. effective way, analysts I'm of effects open and and impacts questions expenses now we that ethical you and It's call you. so totaled of safe non-cash work million the Thank lingering $XX.X researching XXXX, We'll absolutely needle all mental this to today, optimistic $X totaled

Operator

Instructions] from Charles of our question ahead. Fitzgerald. comes today Charles, go [Operator please Cantor Duncan And first

open. Your line is

Charles Duncan

recent Thanks looks compelling. and you I after I target recently. on guess design CYBXXX. And afternoon the question. data you've for a had couple of good the out Compass. pretty data good Doug of questions thanks And team. progress our a know, that congratulations But came wondering, I'm Super, that described product of profile came your the taking about

of yet? the But profile, you've class, that consider profile really really in the And with in any are with What gives you bill? only XXX? XXX you XXX. it been but as profile the data fit parse data make recent there think can that best-in-class next and recent you if know about So hasn't not confidence release, as terms observations the in preclinical particular presented that I of and you a perhaps intrigued that data described

Doug Drysdale

question you. appreciate the Hey good it's from to hear thanks, Charles,

You're absolutely that have and we've compelling, for came was right quite some psilocybin a Compass I but about surprises the study about from XX say the not real time. data known that to lot

it we've depression, a thought data, with and think CYBXXX. efficacy, known I for of psilocybin study of had for our things that's I effective look of some But that so, through confirms that - limitations. it the and that all I but in think And essential there great us. that And is the confirms is, confirmatory with think good when number we clearly are strategy

headache. at the the And could when around in the of wide drug The nausea variability those psilocybin. patients some with are mildly was noted including first levels in is you of and hopeful look and associated concerning effects. that with dose about be or time. side I there's effects, that this about experience to may events, to and plasma of ability CYBXXX psilocybin level in some serious degree associated perhaps half side that XX% with with or known that we're We think suicidality self-injury. much this adverse the We've it for study, saw potential reduction seen a be patient those while also group, And wide

doses half it do one is one the or if we more having the seen know that of but data, And so, potential a time thing events. to necessary, when if we we to robust is is durability as expected. that way, regimen. certainly aspect some may I from significantly I've we dosing variability to less to think else is study then And dose done, the that look are as patients see of the and that factor need doses. be three more comments will at address a goes be need studies, adverse nothing clinic conducive time And those that as these repeat not mean I dosing that in clinic the reduce ability then in think not a least, serious get and that try long is the kind And may some perhaps third clinical at the the repeat of dosing, for through two may the

So, I data seeing really that think encouraging. be from the is we'll

we're think it pharmacokinetic Thanks us of the good probability taken have of the confidence in Charles. in into what CYBXXX that is that. confidence that translate directly for profile. And question terms multiple seeing great we've similar your gives will improved profile is through I efficacy, pharmacokinetic an in and news species. believe We profile high PK a

Charles Duncan

One path of quick would regard imagine or efficacy registration? to and of data especially out of forward? Com terms studies that quickly it to that in mentioned target capital than profile seen as even week Would given capital XX XXX, a from this of think then terms perhaps CYBXXX and you the in super. you path profile perhaps Yes, an ago you With to you you've on more that's assumed given efficient, maybe add first to forward, ability demand IP. move about question program, have the and to be the efficient the so and given and

Doug Drysdale

I a a is rush place analog from. molecule. in be been the optimize the to couldn't Phase shown what place. want of be the drug has that's – overhanging think for to better we starting Often can development, proof-of-concept. a II core optimize - And great in in we efficacious terms Yes, to we just to fortunate a psilocybin that so and study that We're of molecule there's be can

patients in quick escalation IND can to the and get dose we with MDD. the then profile, PK some quickly studies confirm move we think I process, to So once into studies through quickly PK now,

And a question about the…? rapid later I us a think proof-of-concept fairly then it had [indiscernible]. to you path gives

Charles Duncan

questions. could and you quickly that and like Doug all well, a variability. seems interesting less an pretty Yes, deuterate absorption the taken appreciate get rapid just It you compound

And could chemical so in the think that my entity new to that observations make able type you're result question is, about you do profile non-obvious IP?

Doug Drysdale

is Yes, this we new that definitely a chemical molecule entity. think

So and say in oral stability, penetration. lot and more patents to far, patents expect also some so some the to which brain improve we to to protection around space the family enhances this that Deuteration that. filed we substituent creating variability. provides significantly helps some helps strong deuteration that a in of will metabolic of quite bioavailability add and nine I benefits remove addition

as those said. all onset the to So of CYBXXX quick dosing factors you lower and contribute the

Charles Duncan

back I'll added Appreciate in the the hop color, queue.

Doug Drysdale

Charles. Thanks

Operator

Thank you.

of comes go next question Our from Sumant Kulkarni please Sumant, Canaccord. ahead.

is line open. Your

Sumant Kulkarni

for Good taking thanks afternoon, my questions.

First, anything it's Is can a gleaned been made? taking decision be or needs say XX else that clarification that there you to XXX% in that question. preclinical you're trials trials into clinical out already had before

Doug Drysdale

hear Hi, we're good this lead confident Sumant from our to to that candidate at it's CYBXXX move studies. is to you. clinical point Yes,

in We are to in that and have place XX about materials be CROs studies preclinical completed place. ongoing

coping do first around complete we're So And thereafter. timing, filing then the those expect an to in the quarter. we IND we shortly

Sumant Kulkarni

that. Good to hear

any effect on - oral make that therapeutic you and psilocybin translate intensity XX preclinical that of the clinical? comparisons versus might in effect could how the of - So psychedelic to a

Doug Drysdale

That's I a technical action? we're of available is think, question psychedelic the answer Mike think Palfreyman animal Mike are Mike about seeing I'm question capability. beyond I the you line missing my Sumant. to on models

we look So there into clinical can up that maybe offline we from can performed. studies and take it follow and we

Sumant Kulkarni

given know you have entity comments XX full a one, could pathway, that? outlook then any new that make the require, trial a spending behind and clinical kind And of will is Sure. you on last chemical

Greg Cavers

that, say Doug… I go will Oh, ahead

Doug Drysdale

to the know combined leads don't to and regulators we've say the savings. indications will MDD I one single but that then be, that, AUD two expectant combining will we some program, at a under safety total going ultimately itself precisely program. clearly under through the molecule also numbers I'm lead that's exposure and what that as No, hopeful to We by efficiencies. move as

to of course ultimately track fast accelerate designation taking of faster, development more breakthrough through be jurisdictions, therapy, every that or efficient we leads opportunity will can designation We other and to advantage development.

drug the product nature development combining think the programs to programs dose depend given. do of I some leads the So, to and these fairly will that efficient

Sumant Kulkarni

Got you. it, thank

Mike Palfreyman

and efficacy the There challenge psilocybin on Doug, to to is that and to I this its animal mice, Palfreyman comparison and an that compound. blood properties. with model the a And Mike relate is compounds, regard been in model use and there technical CYBXXX therefore apologize, therapeutic between properties, levels that I both and of has of can can one had you potential question psychedelic then the psychedelic in answer that its the the psychedelics. properties what is the efficacy got shown it's same the translational, sense a the with compound therapeutic the to And in variety data pharmacokinetic confirmed of benefits. be different has humans it for the that response we've described more suitable, is would meaning peak you well but terms for to dose more response see of height, in correlates as similar being active favor in of compare that

it's known but clinical to with again, it animal So correlate response. is a an model,

Sumant Kulkarni

Thank you.

Doug Drysdale

Thanks.

Operator

Perfect.

Our of ahead. comes H.C. next Patrick Patrick, question go please from Trucchio Wainwright.

open. is Your line

Patrick Trucchio

evening, questions. you generated good just have a the you have have like follow I Phase on, in extent know, when to versus humans points first to animal differentiation based Thanks translate up would you the compounds? trial? data what if I a plan, Phase reported? would the goes terms everything I guess other to the in data Just I expect of expect is I few And pointed states of you've out to you psilocybin question potential

Doug Drysdale

thanks the Patrick, questions. for

disorders. I in sort on we're in is that in, of translate that you'd XXXX, of which efficacy, psychiatric so be of assuming quickly. terms to the have that's from to the data the proof-of-concept XXXX, into I dosing one really data, I right next thing dose models likely, terms in the animal confirm Phase of in around think early of so about year. waiting data, men CNS to PK that escalating hardest to fairly and start be end expect I the is most we the those unique quarter end the and think of And data reporting, thing around animal second will situation

we Here, of that II have recent study. analogous data sort in Phase

is what properties, consistent that pharmacokinetic are So already. looking to species consistent, already translate we're across seen patent three for which we've

So confident translate men. will we're into pretty that

Patrick Trucchio

Yes, generated would you idea CYBXXX two in been just in on based you or of II the that's doses have spread CYBXXX, development the weeks along that with to-date single clinical anticipate helpful. apart may And that's And you perhaps having multiple preclinical evaluate program? an a then do doses what evaluate data portion could cohort one of perhaps Phase dose cohorts?

Doug Drysdale

the Great we questions, near here. haven't note the final we'll we that we've study down so the decided now, will that the preclinical doses right But in from that that seen, future the likely what range of obviously, the - very study. data half it's dose around have psilocybin that's and the we'll of if of go you doses CYBXXX possible the that's test through range to course, is with range you'd range and that see of escalation

Patrick. was what your second question, Sorry

Patrick Trucchio

a know, cohort to multiple in doses, a you single in addition of, having having maybe with dose? Just terms

Doug Drysdale

that of to leading as the Phase benefits designs, some got useful data we're yes, of something out contemplating. we'll that's looking that of kind having one that's Oh And we there of as we've indicators II think expect. what II be investigate and to certainly Phase the recent at

makes evaluating yes. doses, And a team for at our so I multiple looking lot the sense, think is of already potential

Patrick Trucchio

maybe we should be, be the are maybe be would Yes, the completely healthy this will combining a design I would a and CYBXXX, one of design maybe study these for just Phase agree. portion in would I be in way it last one, way. volunteers filed then anticipate would or on or program, just be separate you I/IIa advantages can be it that what to move the be into the from guess seamlessly that that it yes the would it design Phase the trial And subjects clarification IND IIa

Doug Drysdale

absolutely the work the jurisdictions in the right ship in supply a us to in you're Atlantic. jurisdictions, is Schedule of that parallel FDA, the easier. take benefits U.S. to we a is to some U.K. though that but enabling both in both necessary then chain two with product across having and of enables Yes, for the in some U.S. And the how of U.K. and built also I without working little of us work advantage the regulations

you're So create mean healthy a seamlessly patients correct. study through like nested it can doesn't that into that we potentially volunteers move MDD fairly and

Patrick Trucchio

thank very you much. Perfect

Doug Drysdale

Thanks, Patrick.

Operator

Thank you.

of question next Oppenheimer. please go ahead. comes Francois from Our Francois, Brisebois

is Your line open.

Francois Brisebois

I Hey, the just taking us Can understand another from maybe of just expectations effect the you a help of between questions. placebo and the and the there was MDD thanks TRD? for versus difference maybe data effect company. choice terms in wondering TRD recent MDD why treatment in versus

Doug Drysdale

provide Franc, patients for ultimate and cases, think that many or therapy. other tried of treatment. kind to quite MDD is. those TRD to is they from an patients MDD these I thanks committed just of tolerate maybe TRD really of that trial cases, path understanding the clinical the really treatments a or may might bit a tried patients maybe whereas to SSIs And In more have use. it's differential them. have resistant three the then We've been Hi of And what some any it think some resistant But be also question. there and sometimes to risky misunderstanding two patients think at don’t strategies, and in least I beginning have as be we are effect that about proof-of-concept in the

out first proof-of-concept Either there I with think, doesn't is difference multiple study of resistant start resistance. the try way, efficacy to most between the I sense. BX think a make and doses patients So a lot

larger much SSRIs the if going depression. better other studies to you and look a at We've not with over population. of MDD, seen, than D starting placebo in long-term the patients SSRIs we're with mild-to-moderate study So it's is STAR that, be

the there Then and good always is So got help to at through the population look this option down an will somewhere start. that's of need as that way is a patients, we line proof-of-concept. large the TRD

Francois Brisebois

Okay.

Doug Drysdale

of question [indiscernible] I okay. that's sorry mean and if terms you're people, the second In right,

at every effect placebo, been depression working you're evaluate a to how terms placebo In right, the side. drop study of and we've there that’s is

it but a patients that Med of used to School so tools from some a designing comes study from and screen group in Medical Some using working also with that secondary of we've we General at been and a comes tool screen. the design, is that Harvard

by the would the group a they once into absolutely that the been arm's by screen second recruited investigator the study. patients sure team, have an patients get further basis to the screened make investigating length So perform

and it suspenders an just extra to sure and right that's think right. patients doing of belt kind I the got make we've

Francois Brisebois

Okay, Can helpful. that's similar these interesting. Is that be a a note, those because in better if And analog the might note, think any that the lower efficacy, on very assume to arm, the a the the there placebo very you not that able trials danger might psilocybin would have of be placebo efficacy fair if to X dose share using might thoughts larger it with on be you you arm just get dose. here? as on placebo I milligram of

Doug Drysdale

scientific one of the a as group So into have we we go one debate of advisory or will expect the the it's and with first quarter scientific major our that next in is year. those pre-IND significant meetings questions regulators placebo for

to their get important that's on. views think I

the other try can potentially there I with CYBXXX X.X along we evaluate which opposed not formulation, milligram, might will but benefit that that a because something milligram is that. lower saying with than challenging options CYBXXX that's a to low think am of be dose certainly CYBXXX X one pursue was to of potential its I use

Francois Brisebois

now, in then to just just And potential administration there treatment. the is is could and you the right program and the front trying an on last mostly advantage the of one if Are acting with on or for phases with a there I Okay. side there's based the advantages of EMBARK on the scalability quicker on advantages scalability a have lot interest the a sneak the potential scalability field integration psychotherapy? prep

Doug Drysdale

to depression treatments treatments adopt can't be you are think and setting and by first the I adoption because be administered the one to access. to a somewhere of actually can't the day, Yes, might is fold clinics these they challenges clinics in burdensome end patients and clinical multiple And scalability supervision. are the this the and at physician if have clinic, challenge get

then care limit access aspect supporting molecule reimbursement a which some to session the is is too is a expensive, for hurdle reimbursement, Another is eight-hour patients. the there might around there

ensuring a about are what is for if The is therapist trained doing patient sure be program trained EMBARK to want program there therapists the making and and to program EMBARK infrastructure the the want the really networks program have we're that it's support the clinical those so it's and together make that an training So that it's access. can open they source we tools ecosystem to bringing in molecule, patients. and formula combining with access

Francois Brisebois

from much. that's Thank very it Okay, me. you

Doug Drysdale

Thank Franc. you,

Operator

Thank you.

ahead. of Andrew please Stifel. from go Andrew, question comes next Our Partheniou

Your line is open.

Andrew Partheniou

make it your but molecule program two Hi, good tracks the that's where for with you through your you at or could how maybe AUD. makes questions it my with indications walk for that starting first going a that evening. there trials clinical CYBXXX Thank work CTA applications separate with program off one is for sense could to have MDD taking sense? your I you imagine IND us to two you of mentioned if point point what does combine and

Doug Drysdale

there combine areas Yes, couple the a I for think where Andrew different the thanks molecule. it of, questions. makes of sense Yes, lot on there's is to one

in molecule. one the way pre-clinical The to is obviously say work first

given then needs have populations, safety the separate optimal different an work in is we'll second psychotherapy. dosing MDD The looking to and would they approaches the be we different the and find early that dose it's maybe AUD to and likely

perhaps group in benefit to exposure studies label both For can indications. example would use, open safety and renewable of then the database be overall a terms contribute therapy are exposure alcohol in

leverage see board in and synergies we looking one be to must wherever the across can provide data So we indications.

Andrew Partheniou

Okay, moment and what's different industry your color that think other for for seen or the published a far. have just thank repeat we've here? seen what's other in realize you your a data we've that sticking that but with that to what early, Is - expectation it I dosing molecule it's similar with CYBXXX data with could you be your thus you and little do the players for

Doug Drysdale

study look seen tell perhaps with studies in most II it's had quite different And then think time. most academic Phase the psilocybin, you very when this at recent to effects hard durability at point we've durable expected. I

the effect. clinical makes multiple programs required durable dosing it a multiple we we really repeat good is and our plan that to have reality. half that if is dosing future into Then to So, has - news time, certainly that long potentially dosing incorporate have a so molecule practical clinic

Andrew Partheniou

how do any agonism having some is to given the that on thought, any have seen potentially any negative for indications on of train on heart receptor X-HTXB data that, color you an CYBXXX receptor, and that valves. effects or we've on And

Doug Drysdale

ask about question and have done. going to good panels to I'm we maybe that It's Palfreyman Dr. the privacy talk

Mike Palfreyman

about This good the wanted structure Yes, change the very a - doses When a it's you don't have we suitable about intervals the question. when I we in as talk anticipate dosing. that to that only them. problem essentially privacy is to the what is X-HTXB be stimulate we a this at do between and of stress dosing know And really a daily to repeat that's dosing that heart receptor, seen valves. repeat single

there the that some is of know is affinity this do compounds, receptor. we and a class have So then for what do difference mechanistic -

taken. obviously are designed to, those that we've won't essentially we've risk suitable appeared dosing, our types say do our What in is but to periods way studies the with safety but preclinical every the repeat dosing. are this include preclinical of risk, there seen risks. if in not between have about safety you we in repeat I we at corresponds - is like, confident concept very of we've our we've the eliminated we what individual but the So studies studies looking day, certainly And and not approach going we single

So do if keep is I compounds believe going compound conscious all with that's would you that types that of this X-HTXB the dosing. the very mind this historical don't data think a to risk use going with way from factor CYBXXX the we affect I've and described are that we that just we but of forward receptor, in to to be deterrent a this

Andrew Partheniou

is far, could suited to anything treat really it as the to CYBXXX, disorders do realize if can maybe Thanks point for on talked me that last here existing thus the have share transitioning anxiety much that you one in to just you CYBXXX I And potentially that being about can that, haven't there but from color. what's maybe as any you that great this on fit candidate market. color versus more drug

Doug Drysdale

relation that tryptamine CYBXXX consistencies can some similarities work and the work Yes, there results I in is on is been we've they are in doing between the, some Andrew seen. say so in deuterated that we've some the that CYBXXX both in

In we're quarter terms CYBXXX or CYBXXX a preclinical its is CYBXXX but CYBXXX working the of through way perhaps program. progress prioritizing behind is so

anxiety disorders So it's what you way of apply by the think are particularly can again, slightly maybe good the size about disorders. take from patient's learnings and life six it unsuitable other. some effect not that disorders. for I third Yes, or just are and the for disorders, someone weeks to of in dysfunction staggered that the to an say that weeks some will is not effects do and that's and long, I quite they I side particularly mean – a disrupted so wait these one anxiety. things have suffering the SSRIs whose analyze in XX of sexual in patients. very for anxiety anxiety gain for anxiety respond program current a Also - it's treatments from Is for general cases their like the more to for for suited SSRIs weight patients well it's and long slow

have and robust tryptamine onset rapid a more what work action hoping quick these as and we onset, is know through away share but about of are CYBXXX with program. effects, So preclinical very and we're our CYBXXX durable very those we we'll given an opportunity on to

Andrew Partheniou

And color. queue. in the that for Thanks I'll back get

Doug Drysdale

Andrew. Thanks

Operator

Thank you.

comes Our ahead. Elemer, question ROTH next Partners. Elemer Capital go please from Piros of

Your line is open.

Elemer Piros

Doug. you so thank much Yes, hi

an correct? to just So, that you're inhaled formulation working confirm, is CYBXXX on

Doug Drysdale

not to Well, they similar deuterated really availability course our not that's rapidly we're CYBXXX but it on in and it, of the version preclinical inhaled version of challenges version on specifier. work an inhaled tryptamine [indiscernible] working intention, at just early. create very is using is stream that we're a in so inhaled it first the of In blood delivery use becomes into of CYBXXX,

Elemer Piros

the with the please you or would was first this probably is program this I correctly about hear and talking Netherlands and you Okay didn't think responder or CYBXXX with trial little and were clearly, in a I that - you it clarify bit? mentioned

Doug Drysdale

it's first not responders, workers. the respond COVID should frontline say it's Yes, I healthcare first

in how or result the a professional battle Washington – so we in with facing Seattle COVID-XX distress we the it's know work a with psilocybin is they're would That XX months clinicians University do with those or So the a The is that. kind and of of of working, be been those of do form course PTSD to this to now psilocybin last correlation see as study. study CYBXXX. analog, results we have will for the that burnout CYBXXXX of collaboration as

Elemer Piros

is had. I the it's protocol skimpy especially integration XXX last you think question when Okay, they the the thank that And look and Comp design you. clear, okay at much relatively

since you especially had think Do that you two dosing? I upon or improve thinking sessions. have of multiple think can they you

Doug Drysdale

Yes, I fact looked that to effect. reduced we than sort is we've and session impressive The feel that was XXX something less are - the in will lower academic this may of only of other prep have the or used studies quite durability have significantly. at Comp internally. psychotherapy effects one study the either studies strongly say expected it about that And as omitted contributed

get we for the think psychotherapy prep and program patients to prepared well inbox sessions uses three very it's So treatments. our important

most treatment the that impact. So the has

Elemer Piros

Thank much. you so

Doug Drysdale

Thank you, Elemer.

Operator

Our go next question ahead. Capital. comes [indiscernible] Seth, from please

line is open. Your

Unidentified Analyst

guys expansion DA you congrats Doug, of license. get continued wanted got space, your I would what you also manufacturing there color on in need? labs some that up you you if the obviously evening. that better and good just is you the to on to have that's to and Thanks the if opens that footprint other one really need expect just license get

Doug Drysdale

questions Seth. the for thanks Yes,

to across partners the in many, ready or getting year heard working and synthesis been conservative you many Europe more to preclinical studies. America as North activities we've last from with clinical over for So work the

have been scheduling, right we've the ecosystem to so feels scheduled on into partners necessary, of were controlled able tap lines that so, it licenses. And this substance

own mix having So more results benefit to the and of license as stage. the work also that we DA work that at means early internally just costs at way internal that well turnaround efficient a But slowed particular hasn't it from all. deterioration our rapid a to means means and what far discovery as a more that reduce it do much Schedule at us from do X down can

to have that's year. exciting term team now rely to some I'll that completion over on our do head partners and external So the internal of that

Unidentified Analyst

Got it, got it.

trial that that of your is So or you kind the will own down be acquired the high that cGMP for quality kind of facilities more line? at need API

Doug Drysdale

mentioned I secured U.K. clinical small ready cGMP is our has this for So it's manufacturing to in but and already be that established and studies. it's we'll supplies scale scale chain level laboratory supply and the use. We've materials U.S. able called small been as supply

but supplies supplies on so jurisdictions, having backup options for the forward on clinical going ourselves importantly work given that in we've commercial also the supplies. flexibility to that's, have we So multiple

Unidentified Analyst

Awesome, awesome.

for a Just like terms heard to that one plan pre-IND me, year? and the into trial next you advisory and an the panel. plans have think be similar coming sort there'll question like you design of discussions a do update of some to with last that speaking and multiple the back MHRA, the potential market development on discussion, potential of from things And the jurisdictions around of your early that the discussion I do in mention maybe

Doug Drysdale

good Yes, question. a it's

very to discussions shortly, the MHRA, scientific have for FDA in advice hoping with them quarter. and out the can So, from we with we first actually reach expect the and

if the decisions design, trial clinical around they inform will, is, there if certainly they as think our those on an we provide can I to if market then update conversations that. per

Unidentified Analyst

Perfect. the Well, color today. care. thanks for Take

Doug Drysdale

to Thank point, the And this to it's run all have very to for you At much thank - everyone and we other X:XX. questions. you meetings.

questions. much the very time to want thank all time to the Thank today and and you you have your to good much I for putting update a business for So all night. listen very the to please

Operator

Thank and call. you today's now disconnect you, your gentlemen joining, ladies for may Thank you lines. concludes this