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Cybin (CYBN)

Participants
Leah Gibson VP, IR
Douglas Drysdale CEO
Sumant Kulkarni Canaccord Genuity
Charles Duncan Cantor Fitzgerald & Co.
Sepehr Manochehry Eight Capital
Jason Shieh H.C. Wainright
François Brisebois Oppenheimer
Andrew Partheniou Stifel Nicolaus
Michael Okunewitch Maxim Group
Call transcript
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Operator

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to Cybin's Third Quarter Fiscal Year 2022 Earnings Call. [Operator Instructions]. I would also like to remind everyone that this conference call is being recorded today, Thursday, February 10, 2022, at 8:30 a.m. Eastern Time. the Leah to Gibson. turn of Vice now Relations, Investor will call Cybin's over President I Ms. Gibson, go please ahead.

Leah Gibson

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

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

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

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

Douglas Drysdale

joining Thanks Leah. Thanks, Good everyone. the call for today. morning,

the that momentum for was new active into productive that, And December Cybin. we're XXXX, XX, The continued pleased year. ended truly third quarter has and

in of studies; ecosystem, DEA that receiving the X following: license CYBXXX, preclinical our a support capabilities our notable study in a deuterated Boston; the neuroimaging the launching facilitator several During the including announcing depressed first-of-its-kind FDA positive a achieved matter. our overall for quarter, the accomplishments covering receiving psilocybin analog, deuterated expand R&D Flow grant data significant from molecule, into approval our psilocybin manufacturing demonstrated with internal evaluating Schedule advantages evolution to psychedelic to for we psychedelics II and care health program psilocybin to composition clinically the subsequent Phase study technology; a for patent EMBARK U.S. it Kernel DMT quarter, receiving training CYBXXX, investigator-initiated integrating of providers; using and help for

XX XXXX. advancing which We to our studies pleased discuss Cybin's completing completed preclinical clinical escalated studies completed work with these January true progressing progress to we're as possible has psychedelic-based tremendously, patients psychedelics at which as quickly into alone. have into in of therapeutics over XXX we continue announce hard need. development, make to rate commitment we for important testament detail a is compounds great to in of XXXX and over shortly. The And that in these will beginning since we're This studies

that of a In reality. grown veterans community. in throughout increased mental the believe several work. have to also interest North industry and past we we the supply support Cybin have programs accomplished sides continuity studies. clinical carrying to chains strong and have the have built leaders, have team Atlantic. America multiple a to Europe prepare we garnering the our out people, months, turn right And into strong both disorders internal partners across We parallel, investment for is health and we our on established During that talented to now ensure vision scientists of excellent foundation treatments our We're improving pleased this for

New to X the is trade of X top were stock, first companies we XXXX. named now the first to And -- psychedelic the by analysts. Exchange, X York covered psychedelic psychedelics stock Our sector recently the the sector equity in Stock watch on in

approach, overstated. discovery strategic The health delivery our platforms, can't need with address and innovative be resonating. formulation drug mental proprietary systems disorders approaches to So drug we're is novel including pleased

better While society impact exacerbated individuals, find has crisis And has with metal frankly, the as the enormously. impact challenge the the and of on the to are, been health a families been staggering. decades, treatments The us whole numbers never pandemic greater. has for

another before, deaths. Organization estimated year, a As large million this the XXX,XXX is addressable we've worldwide great With every shared by account need disorders estimates globally. World with than and health deaths that mental worldwide more deaths an Depression people suicide XXX X Health for million comes market. affect alcohol-related widespread,

for a health we're support care Hospital part As the Manhattan very awarded accessibility, first safe, York the thoughtful of Lenox clinic communities. system Health, through the ecosystem psychotherapy trans-diagnostic This accessible of is support our psychedelic-based need. psychedelic November. to on patient of training to Hospital a Northwell efforts hospital-based therapeutics largest underserved last in and flagship New is Hill marginalized is focus also creation in grant Hospital proud grant State. Cybin's our the psychedelic clinicians example effective Hill of one to will for commitment treatment our of everyone serve EMBARK, in toward These receive Lenox and which model,

studied tryptamines that say turn molecules therapeutics. medicinal leverage psychedelic programs goal DMT this into phenethylamines As using but fewer demonstrated data is development side to some that institutions doing of derisk experience. modify College classical and potentially a and already Imperial and Much offer improve name they've as delivery other base can the and be technologies there's scalable of and is us potential before, developing academia approvable psychedelics London, improve in that's capture overcome harness payers. the done. of our more order way, the develop therapeutic derivatives patients of Johns you've studies, these work to limitations. the drug in efficacy still patient prescribable for there out efficacy versions can of and and these effects, to We're less to NYU to understood at as and accessible chemistry our about potential such currently and been that the and and but few, we we're Cybin, these heard in power on and molecules to In be specific these and decades in molecules variability, molecules by analogs psilocybin, these for Hopkins, much providers esteemed and At

metabolic PK these with curve the Deuteration also body. So Deuteration let of the is through some breakdown hydrogen on molecules with you improving me a walk of advanced tryptamine with these simply affects these Starting and brain heavy helps analog most is psilocybin. opportunities. atoms molecules deuterium, the penetration. substituting which by and inter-patient stabilization variability CYBXXX candidate. our in It of CYBXXX, deuterated hydrogen. is

And We less around in been use submissions, MHRA with aim we range of gain profile our those selected for and we're Advice alignment trial AUD. tolerability. currently In potentially a to advancing have and our end tryptamines, on year. will the plasma process studies development. reduced the compared may clinical should that in that the perhaps ready a necessary psilocybin, modify action, next quarter. in-human applications enter believe the shorter Overall, productive trial believe the our we trial now we disorder, planning and this Phase levels, I/IIa So side clarity providers treatment this contract treatment this We're initiate that and revealed can support to the using submit that for organizations CYBXXX in to to of the and duration believe the I'm faster inter-patient patients classical be first-in-human dose, variability. up evaluating to have a Phase in of These U.K. CYBXXX the with pleased we've targeting for effects and we wrapping recently of reducing our program, as variability for and result and report to and preparation We're for design clinic clinical MDD around the patients traditional of trial depressive or a we to onset aligned that midyear. time half therapeutic of the payers. we we materials completed produce we in clinic our of depressive which patients CYBXXX and had better quarter in first alcohol disorder, the clinical major our major for MDD, a with benefit work, research process regulatory I/IIa or clinical PK potentially preclinical in get Scientific Meeting second steps have disorder.

Let to me say path proof our a clinical of few about words concepts.

to by It an we trial. summary, and PK see to efficacy be will the translate on Participants and data, week toward X its safety enrollment, better to to more an variability doses design psilocybin. oral believe Our study potentially a for conduct protected preclinical of and into MDD; and single at a suffering to the us CYBXXX also doses, therapeutic for Phase approach very recruitment to important first, end development. CYBXXX and some a of into overall accomplish I/IIa see dosing of remission administration this year. of family may on predictable And burden things: Dependent is outcomes. development provides MDD interim dose. treatment. evaluate allows receive to combine over for potential data of treatments assess trial advantages This lower second, and enormous double-blind, to based placebo-controlled assessed we single CYBXXX patent X a X again In patients at patient by time one safety payers presents opportunity second the response from and clinical dose; and resulting We program could the efficiencies Phase randomized, evaluate efficacious X and a patients, and that dose and resource savings in on and week on than third, accessibility in is I/IIa will providers efficacy. a more cost scalability range of improving AUD to in identify drug and impact from filings, reduce

treatment changing more from of to our smoothing and we classical take a the in We proprietary reduced short, the dimethyltryptamine, window CYBXXX. for apply optimize spike, dose the better as versus longer disorders. that increased our has patient CYBXXX effect are DMT. them deuterated CYBXXX alleviating improved control disorders been DMT, PK of that anxiety a from designed out curve, duration negative to on therapeutic we'll CYBXXX with a experiences version just of curve evaluating for commonly through treat is our Moving anxiety keeping and the of known sharp here. of it time. to program certainly aim And learnings period safety, potentially for DMT, effectively

receptor actions and disorders. studies real-world Now a in demonstrated on like And a CYBXXX, CYBXXX in use substance has is of of anxiety Efficacy X-HTXA depression, X-HT range DMT, observational agonist. been CYBXXX receptors. has range like agonistic a and

is DMT administration as Our orally utilize very goal platform a precise not is to approved CYBXXX rapid route with an as for of dosing. lungs bioavailable, control combine when a and and inhalation the onset

with U.S. As announced just CYBXXX XXXX. were yesterday, a patent we to protection out granted covering

we in of and application quarter and strong this program. initiate patent issue, CYBXXX IP as As we're psychedelic-based a quarter of X our growing regulatory milestone this protects of is making in compounds intellectual first-ever for place a it in to to that plan further and pilot significant study both company the portfolio path XXXX Cybin protection provides With the second clear solid development, protection study a and our the supports investments to and year. a property our file for in the critical clinical

and are know and molecules conditions. MDMA at psychiatric Turning CYBXXX for doses what at now to These there's assets to treat are that proprietary early potential CYBXXX, research, derivative. our Based from we effectively high low treat to like a molecule this phenethylamine doses about mescaline. neuroinflammation discovery-phase on

number of combination be also be very asset doses. in brain could head conditions, observing that a oral long dosed which or non-psychedelic then X-HTXA means treatment a seeing deployed twitch are duration CYBXXX. an chronic lead in exposure, a potentially models is neurology of animal Alzheimer's great seeing disease. properties, characteristics and We're limited Parkinson's potentially could We're this or psychiatry potent evidence at infrequently and agonist That CYBXXX penetration anti-inflammatory of Our it is with bioavailability, psychoactive. responses and peripheral quite with

pandemic we While can it looks is Cybin's the partnership. be through of of a asset being research. value news And that reports this We've Washington, on program our of to of our psychotherapy very the a an frontline evaluating more COVID-related University for core interesting investigator-initiated patients. with describing magnitude is learn clinicians impacts honored CYBXXX EMBARK in our strategic workers, frontline psilocybin be at and we're outside the trial watched this They're by the molecule, to and preclinical sheer we doctors, clinical all experiencing believe hospitals interest tirelessly build through health ill COVID and nurses, therapists care of psychiatry, to internal workers in that traumatized out continued we're critically working unrelenting the Outside programs, a co-sponsor is surge conducted and homes. about in other burned nursing and depression.

to following but pandemic. enroll is frontline COVID-XX distress, We And studies see November psychedelic-assisted the Clinical combination will aim by adapted indications long professionals. study understand approval exposure the Alex can also will clinical anxiety, IRB and model CYBXXX EMBARK of measure, Belser. The symptoms approximately in which psychotherapy of significant learnings existential and the and post-traumatic clinically be EMBARK, clinicians this the use as trans-diagnostic secondary using with XX II sixth stress the enrolling our overdue. Dr. frontline received from a importantly, inform XXXX measure; trial model II during and effectiveness as Officer, currently psychotherapy is of CYBXXX. to in of to a that Phase an better and is timely, this The will domain range participants. depression, was Chief co-developed our our The So of trial anxiety, trial address important and upcoming opportunity primary designed among of Phase human treat populations. study EMBARK depression symptoms burnout this

continuous hemodynamics. we're and quantitative uses on company-sponsored in Kernel is with to external Another cortex measure study experience IRB Flow Kernel psychedelic subjective pulsed study of feasibility reporting. psychedelic Kernel, very technology Flow and effectiveness quantitative the This test that program about light projected into psychedelics effects excited we its longitudinal the Kernel is January to in will and cerebral measure instead evaluating fMRI look of treatments activity patient in approval Flow is neuroimaging the collaboration increase technology, system instead a helmet. measured to to that contrast and off before, the a to Flow study In psychedelic support soon. the collect of mission having wave develop the kick after The studies Kernel of work, lie possibility information. data that ground-breaking patient is on but during easily to Through light brain scanner, brain therapeutics. further The exploring rely a to require bicycle our is is and a size received entire to wearable. hope

we a we lot that XXXX, believe all of cylinders. year we accomplished really short relatively of Cybin. have a So transformative we've firing entering be And work on in XXXX ahead. space deal a are still while truly time, And will a for great

briefly now our to financials. Turning

December cash our totaled XXXX, $XX.X million. and XX, cash of As equivalents

million the expenses XX, $XX.X million operating $X.X were $X.X ended total for nonrecurring million onetime $XX totaled quarter quarter cash-based Noncash December which of Our of the loss expenses for totaled costs. for net a XXXX, million.

you. the from now our line. for instructions. and will questions with up ahead Thank -- call the analysts go please Billy, the We open on

Operator

[Operator Instructions].

do Okay. have We our first question.

from from Kulkarni Canaccord. question comes Our first Sumant

Sumant Kulkarni

couple. I have a

The the pipeline is one. the on first regulatory second and interactions is

FDA of some now you interactions to with yours, interactions FDA few expect perspective. from informal there and you've issue the including psychedelic So provided involve data getting Could the already? of we've other IIb pipeline ripe Do out had other the had DMT industry guidance characterize with that on there, the and that are programs X-MeO-DMT -- psilocybin, on Phase your an analogs for on any regulators. you And molecules are an you a use U.K. details psilocybin therapeutics?

Douglas Drysdale

our had to We've from very as we're that we've the productive. and IND not will thanks file yet by the words in for say had as track do the need to going some on we're got very heard. had with encouraged positive good don't FDA, in we quarter with mouth, Obviously, and second a And valuable their put to continuing an I And meeting very question. anticipate to year. responses questions it's that you, this positive not them. but planned, we're feedback what directly interactions we're We MHRA, CYBXXX. of a specifically the Sumant, we on to and meeting that hear will we

question anything through about we came other future enough of to get studies, we honestly, there's placebo as in but aspects Phase and But I not not your when various just sure more about I'm I'm of evidence surprised be more the guidance support guidance. hearing we'll sure guidance, or these necessarily data dosing, Regarding guidance. if yet see not various wouldn't things, II learn yet. and some

Sumant Kulkarni

XXX, you alcohol? interact some Are the a pipeline, details with patentability dosing? And it. getting used perspective? CYBXXX, could And you Got combo molecule inhalation chances device to that there expect on any that from on of as drug how do give on when the then this

Douglas Drysdale

that and families tryptamines, maybe take and protecting we have one covering programs. first covering So patents of our three that I'll CYBXXX of one -- the CYBXXX family

The second is family including around And cetera. delivery, family the various around filings is the et forms inhalation, phenethylamine on. that third working we're programs of of

So we're further there issue, opportunities certainly further protection. IP as hoping that -- for will those those be protection --

Our moment or simple either CYBXXX nebule general thinking the device. that'll liquid, of at would nebulizer, the provide a go powder formulation which a approved a an into into a targeting is

is retain CYBXXX, alcohol pathway hurdles. want it the but we And that and benefits regulatory to without So question the brings, use alcohol for that priority then of high adding certainly on still unnecessary disorder for us.

first. We prioritizing MDD are

year, we the more in then AUD that year. why that's early of of as beginning the so the the this proof program concept. you're MDD through share middle And get on seeing study we'll And

Operator

The next Fitzgerald. question from comes Cantor Duncan from Charles

Charles Duncan

or can Yes, from CYBXXX of had sense bit terms Then when on observations? as regard with couple a trial -- MDD, to little but XXX of give updates progress us able of to of a in a that questions. you be to even the I trial safety being well you I is issue, on patent. how updates the Doug question would that timing? one, had I early know MDD or do the going as big and and you team, able when the -- follow-up provide Number in the congrats anticipate a incremental it's recent trial.

Douglas Drysdale

for the thanks questions. Charles,

in what track for we're We're kick yes, So look IND we're midyear. file so by pretty of terms you our and Washington with enrolling of list to that began our to in I University that study tell December, patients in the investigator-initiated seeing X,XXX the waiting interest already quarter that in trial of the study. encouraged study. second can off the there's a on around for

don't see, at huge point, I a recruitment hurdle. being this enrollments and So

So news. that's good

I our and to get CROs have study quickly, be should we think the able go. we to quite moving ready

data, think showed terms year-end, II Phase COMPXXX of have for a some PK critical expect of we really that I In we I I by that the And study efficacy safety. of from psilocybin. comfort lot with us. should mean, take that's view and clearly

variability. So in of proof here faster PK show course, duration onset, confident we psilocybin analog, CYBXXX in to with we're is this inter-patient fairly given well, of efficacy. concept -- a profile wanting but the can that we're that CYBXXX, what improve is really just shorter that of And and efficacy, not

into So certainly, end a we glimpse a that of this and year by is the hope. our should get view

Charles Duncan

follow the say, all, X Doug, to then wondering you'll Very of if, trial, patients good. first initial with And beyond, that regard weeks.

still seems of be on resulting X like then, maybe would shorter But in kind X biological rationale could that experience you out weeks experience wondering if I'm a And to, and could drive you of have that you or if psychedelic duration rationale you'll duration if for of just the at longer? follow drive quality I'm guess, just speculate quality responses that biological at or the trip, experience a for It you enabling look weeks. say, I said XX You can sense But shorter efficacy. may wondering will, efficacy. a that.

Douglas Drysdale

question. for the Thanks Yes.

as study. we're spend get share those studies less one until And I'm that Regarding much durability specifics yes, so I use many study. the likely we that's those the that and we clearly, look to we one in study, and -- of of FDA When CYBXXX into clinic. clinical in is that more with interest academic think getting effect very spend of impressive up, to think well, And to Johns confirmed. obviously, going them trial don't I design NYU, of important. we and And than that's necessary. the details have But our want time the on is and at get more are the dose, approved. likely following we will too think repeat studies benefits Hopkins most patients as

amount I that's regimen, dose is second are So and durability, in molecules, so is appear adding these if decent think that time where DMT treatments, or to, be dosing state. still I that think here great shorter-acting ketamine, therapeutic trade-off. of into of the program frame, We're of is durability the not There paradigm in real so likely to along leads course. with psychotherapy CYBXXX And to a a short-acting. the a that the time that super benefit. have shift then, course, X-hour

so And we with hope, durability. some meaningful impacts has combined dosing, repeat the on that,

Charles Duncan

to DMT on terms is in current at key guess, patent question XXX actually over see yet, being forms XXX. differentiator? looked hopping appreciate I I'm for wondering, really the a guess, quick with that, and that patent value-creating candidate I'm or I deuterated over of with wondering, that the for observation intrigued I'm the the I you is Next of haven't your DMT. is what And I that really but you, color in anxiety.

Douglas Drysdale

forms of So the patent, of other number and matter and CYBXXX DMT actually Charles, also composition covers X-MeO-DMT. deuterated of for a

future your And is anxiety a back amount in an question spike, really in is short be a we're patients DMT rush. short as as What with quite about what get potentially. them that create patients well So down is and And and state. up that seeing can duration what PK of going some -- minutes. with necessary previous aggressive to see perhaps window us to really, XX that very takes maybe you therapeutic they that and for long gives above therapeutic time options classical enough not we duration, patients up think within the

of the oxidase. breakdown monoamine benefits the the DMT that deuterating of So DMT by slows it in body

can therapeutic patients that for we in we smoother into and so curve inhalation that down to the a with window of get titrate slow And time a be way period should the platform. able longer

removing really into it's getting the that zone, state period if you being the scalability anxiety, manageable in then patients quickly accessibility. and of helps So like, about of able the into them the out state therapeutic get time, a to and with

Charles Duncan

Excellent.

innovation. So kind strategies, X but opposite, same as the similar of CYBXXX, different of kind but the

Douglas Drysdale

You're these like, a and there's right. of psilocybin know DMT anxiety blurring different molecules, between comorbidities conditions, depression. and And lot of receptor between edges, the of profiles. have slightly and you course, if X We PTSD

the It So with to them match of right options they're patient. right physicians. we a treatment offering the for think helps range

Charles Duncan

sense. on Makes Absolutely. Congrats the progress.

Douglas Drysdale

you, Charles. Thank

Operator

Sepehr comes from question Eight Thank Capital. you, next Charles. The from Manochehry

Sepehr Manochehry

dose? moving characterize placebo of forward. you of kind -- Congrats on with COMPASS from guys questions X of the the discussions And of terms kind my share gained know mean, been I'm your that if regulators your happy have the answered, but of part that? milligram to MHRA, recent to be you can milestones. I on the as I want similar to program already with to Is I placebo are and to having. the start going wanted regulatory hear that thoughts share you just insights you've can A in number

Douglas Drysdale

Yes, I can, Sep. for question. the Thanks

psilocybin convinced X over evidence or forward. a X to use a using Our do I tryp a for any open placebo have study. as that potentially we not we benefit an think real go initial plan true regulators this is is milligram that in question of that milligram But entirely this I'm placebo. has

the right academics, I patients and good we sizes. in meaningful so way we've if controlled, there's screened. the dosed large that effect well in seen see, quite as should are and quite study think preparation the and is They appropriately some have selected

of So forward. complicating do I'm placebo move not about question a concerned or I we regulators for placebo think point. this issue But too that's the maybe the as at

Sepehr Manochehry

there And certain of there I in establish? will placebo? guess, Got kind to will sort other characteristics put in in some controls it. in put place of that be masking Or equivalent some place place your be mind to the case

Douglas Drysdale

the trial is that sure make fully of course. blinded, We'll Yes.

Sepehr Manochehry

the do into have that look And MDD may AUD program if terms at pilot give Or drinking have they Phase design a the for in how some And insight able your to after be I/II potential of trial, for maybe analysis you'll to to and you get days it post-hoc criteria? data designing inclusion being size? be cohort? the that maybe will to not powered you

Douglas Drysdale

with them we're or look studies And be when at that downside, taking indicate that moderate months. controlled SSRIs that point that feel not and two they're I you are off may be on mean, the that their could effects a when the these patients the to or different last small criteria recent important now neutral patients their XX and SSRIs I that from down, assume either seen currently also, controlled. as on patients evidence leaving slightly leaving X patients on as X think But be are in long that titrating Broadly Yes. very we've population importantly, populations, saw can titration rebound we would you depression we this to is tell SSRIs. not the populations. like an inclusion MDD severe and the AUD And their speaking, I positive.

patients world So SSRIs. in really think, I it's the a not their off to practical, clinical real titrate study in or

an think therapy. as sense So much makes we adjunctive position it more CYBXXX to

difference the adjunctive with SSRIs, important an patients is we're on redosing. that and think I study. So we as It's at doing positioned staying as their look

Sepehr Manochehry

study, are its the Yes. placebo checkmarks No, and likely the success. key differentiating for terms that of hold and both in

one last me. the from Just

You some regulators. of characterized discussions with your

So a pre-IND consultant-based more have had that the FDA? you meeting of Or you kind discussions? to? just with plan has Or been do

Douglas Drysdale

XX for Tom have strong was very advisers, Head Psychiatry lucky we're FDA years. including Well, who Laughren, to of

we that. have So good pretty into insight

have with We have with MHRA. the we Health met and Canada, met

some submitted on input So quarter. to meeting. pre-IND good expecting the FDA. regulators. to We're We're the our we've from IND a to second We've submit track in not information had have

Sepehr Manochehry

Understood.

So the There's IND ahead? submission is next the meeting no step. Understood. pre-IND

Operator

we The comes Wainright. Trucchio question from Patrick have next from H.C.

Jason Shieh

you Jason is for Patrick. the milestones that have on this congrats guys speaking for year. This And

have more So kind quick just a questions, bit CYBXXX. of expand X little I on

study? so one enrolled in of baseline PARI the of how And study is terms soon I -- any after the how of do Phase of to study majors of transition patients have Phase like the in anticipate the the program? of IIa portion the kind the the scale And the PARI could could characteristics improvement? look program the first the that, And Phase you what or completion IIa you do idea

Douglas Drysdale

Yes. study. Jason, nested to you, the going for This be is questions. Thank a

MDD. anticipating We're study. So the we're of expecting into we're looking not a Phase true to X with -- move patients aspect right

be pretty anticipation, time to cohort So some We'll say, process. have there the to go at of that MDD considerable healthy about not save through us a amount regulators confident least. delay That's won't of what that. feeling in but we're which our moving patients, and will see

difference MDD. get be severe the protocol the Look, all. But X-point that you to of as and than process And with to IND clearly evidence that matter As a through we're these with finalize and agree we we final regulators, patients believe expected upon with more is I share details mentioned, scale. the we'll that's for this out designed I expecting course, the are moderate on based there. of

Jason Shieh

right. All

EMBARK. question, for little just bit more Doug, just kind the additional follow-up color. have about discussing early I thanks, So And -- like of a a

study therapy II of to applied And the is can be? how us be EMBARK Phase long used of so like the also will that of total? IIa you what at co-funded Phase status how kind of do kind finally, Phase like could investigator-initiated then anticipate trial the And from study will be And you utilizing just learnings program, II sessions CYBXXX? having for the Washington? the remind the including session in that of many protocol the University And like for

Douglas Drysdale

study in at our very therapists the we EMBARK investigators study. of for the the us helping MDD trained so We Yes, think, Washington valuable, you. and going University thank questions, is great the prepare to from Some year be study. a training. the of of course, training the and be EMBARK modules the learning and that lot last process logistics we'll of the of from learned And deployment through putting that of delivering end at together

began think our a study enrolling test I University of run is this That a thing move before in So we smaller it kind was December. if to enrolling. for like, to at with do you MDD into EMBARK, have It of Washington study study. smart

that already, X,XXX As I participants study. in line waiting mentioned believe, there's so or for I

So that's awful an got lot of interest.

dose bodes that going psilocybin, milligrams psilocybin for milligram MDD recruitment our XX think study I forward. there's study a X single is of placebo. a well The for versus of

study and been some measure we're from get So sessions up scale using a adapted we baseline there. to And versus is sessions. EMBARK that's prep it's that may that, study. insight although fairly for using we're X that yes, changes to the X program integration of small The matter

As move can from to I test optimize EMBARK And closer this move learn kind we program see to commercialization. we is I we the as of run, pilot run, so the definitely forward to opportunities deployment. said, a work as

Operator

from Thank comes from you, question The Patrick. Oppenheimer. François next Brisebois

François Brisebois

here. Just a couple

on share wondering of So shared we'll ready was more, have I/IIa more you're just I but detail to with far. Phase design the so what's the as

clear all doses? and X Or shot X you X? you and then So on analyze shared, on receiving dose do off it are bat off Or then those at side, patients the get and then and receiving at week in the of come just anything another is will when then you have -- you the dose, X check that the But dose -- -- X, for Or at just X be week So are -- won't off SSRIs. Is then would you've first those? the terms X? SSRIs just doses? have timing helpful. dose and doses you is X, to it be week their and one the come that they not of doses week to this repeat the

Douglas Drysdale

questions. Frank, sure. the for Yes, thanks

have dosage active patients, of into dose we'll to cohorts least the of at CYBXXX subject strengths with different course. placebo, divided So and and escalating X

week point, dose. first we'll at scale for dose, at and the another receive will and the time at on active X matter placebo, We And remission of everyone dose X. that and response will measure

placebo So X. at second the The dose at dose active patients will week receive a patients receive first a will week X.

measure patient So X. And week again. we'll meaning to at the good then response that's a -- and retention. gets study dose, remission that means that with in everyone for have patient

us doses patients at help impact And see X that X at looking of So doses and look we'll there difference X. think range efficacious dose us It an will the us of dose will we and efficacy. that, gets design at into more than quickly. one on determine the very dose between help by a week

we quite that. to So design, from expect trial lot a simple quite but a learn

François Brisebois

Okay.

Okay.

they at question this -- from doses, was someone than that So X more X-week and similar doses. X have fair? of X earlier, and doses, X just on to to at X, X but patients the get be a clear, never that week so will since is Charles' Is duration time you receive will those X

Douglas Drysdale

in yes, the of there'll at think I some can't longer-term this that specifics be at say with just looking in follow-up. you share I that point Well, time. benefit I'll

François Brisebois

Perfect. All right.

that. wanted Just on it That's clear for me. to be

Douglas Drysdale

Thank you, Frank.

Operator

Instructions]. [Operator

from Our Andrew question Stifel. next comes Partheniou from

Andrew Partheniou

you the a useful feedback learn share, in Any a U.K. realizing you point little didn't Maybe expect or believe limit want that What that you could to about could did that is bit you you that the you design talk that starting perhaps from meeting? guide of the may you MHRA trial? just off, but meeting? what to

Douglas Drysdale

verbal we feedback said it because And Andrew, and get thanks want and too got for Yes, positive don't during as I questions. specifics the was your productive. I meeting. clearly, many before, Look, to share regulators uncomfortable really, We're full a But a feedback receive that. package. we CYBXXX will or pre-clinical also, No bit expect, as full course. we some -- in a from us. little developing written surprises, with due a

So I mentioned, in MDD our plan is to go right this study. into as patients,

the And our or so changing meeting. changing are plan direction no that our surprises from

of the So team I a briefing the that that's -- the materials think the provide we to lot level MHRA. that -- and preparation to speaks provided and

of their a did out -- and team the think efforts job of it's positive fantastic being prepared. of think that that a with we I very And walked I feeling no meeting testament to kind surprises.

Andrew Partheniou

All is ideal process be ideal partnership? right. That's could Or at would encouraging. specific an CYBXXX partner? an look to the Who and On the you point to for timing could this program? that Could mentioned within to that you be CYBXXX, this partnership. partnering to And potential XXX you establishing open you perhaps clinical for all?

Douglas Drysdale

Yes.

So interesting question.

very out phenethylamine So thrown we so XX CYBXXX, has That molecules. interesting. program is or think,

And that so different awful so promising we think, these lot one seen potential, molecules. low at lot at on far awful the has and oral now we've of of pursuing we've is and of we're penetration an an impacts brain looked most neuroinflammation in This bioavailability, potential terms is doses.

really bit would on a of interesting psychiatry outside lead little outside Clearly, is want of bit stay low-dose information, to we much we a is little those So molecule. a typically focused and that for pursue, approach the chronic very kind programs. --

The pharma that poking with a we're little seems begun year, range companies. maybe of fully sidelines the a a around commercialization interest big change last seeing around was, IP right intense pharmaceutical bit. and across think, engaged I But will say I'll bit on trial already of pharma a quite we to I the now conversations where designs say companies asking and from and wide questions little big a that involved quite models. and be team's number So in the have all sitting psychedelics.

natural would probably So expect, with sector, given or existing MS. companies franchises, And there maybe would could even potentially that CNS I Parkinson's benefits more in year. or neuroinflammation have the over molecule a fit expect, be certainly be next to in the I transactions for Alzheimer's this

Andrew Partheniou

And just a more housekeeping question. of

You the of that MD&A. that's that expenses of the provided might or wasn't And out drove Could Are you cadence guidance you programs some thinking expected? point to want you any on could discuss that your of additional timing that future you ordinary? anything maybe increase expenses? identify about good those the in accelerating the to anything and

Douglas Drysdale

Yes.

breaking I think we our So available website in out our a you're well. by our today, Investor quite lot of right, spend program filed also and is in provided on which as we'll -- is Relations terms make detail MD&A, of

any up a of follow questions. detail specific So there, lot and with to happy

any calendar looks to as seen definitely That around our we an flattening of fluctuate and based spend quarter up it's mentioned $XX per bit months may next really bit CYBXXX will And down the CYBXXX or I program. continuing. in -- we'll we've I like spend quarter. going focus the a XX -- increase I needed spend, around a But As 'XX programs. million run $XX spend mentioned that's rate those quarter in have be may be little the little and Andrew, before, bulk upon R&D think as SG&A progressed, that any of R&D -- a that XXXX the million a particular see for in

Operator

Okunewitch from from question Michael comes Our Group. Maxim last

Michael Okunewitch

ask EMBARK? Or potentially of continue sort EMBARK the to psilocybin use some actual to program partnership opportunity first for an Is the the licensing regarding through just or so bring to guess, to approval for have next-gen I'd like EMBARK development your program. with this to I more So this demonstrate one, psychotherapy there compounds? is a protocol

Douglas Drysdale

for to distress. so health point focus thanks the the is what to for of opportunity, those future I and But not question. and learn this we is. for care investigator-initiated think it's that to us COVID-related valuable providers the you're understand I That's of developing indication Michael, studies, Yes, asking. We're out for primary think that great EMBARK about more for help a specifically think, a I at the the any the treatments initiated -- progress that -- study, looking molecule. it

psychotherapy or less important psychological or the the it's to where that, results academic We're think with studies reduced molecules. psychotherapy are is impressive. skipped, combine these support that I seeing certainly

plan and is course think our months. And more source that of some EMBARK be get several and our over make do want to open support We'll our recruiting as the want about started more for to So we now important. level therapists a training facilitators program, psychedelic-assisted the goal trained studies. learn is of that for next to psychotherapy. We've doing

Michael Okunewitch

run strategy, earlier-stage you of a the the programs overall programs there bit in for the and of studies on shift about but towards in analog, broadly advantages as the comes you instead I bit? analog trade-off from you All mean, parallel? time need that program guess, in little discuss Could rationale right. are follow-up, also a initial to the touch obviously And with focus times a psilocybin to I could of just that then, given more market. sublingual number a to both your on the the doing

Douglas Drysdale

Thanks, you. that we There IP the refine an are we so thank Michael. absolutely, and around towards that end a better a as plan that you're often have potentially IP direct right. treatment, of did commercial better molecule. Earlier, around Yes, we we Yes, hear year, some We've going psilocybin focus. believe psilocybin the challenges our challenges last from partners, challenges. And and X-hour an issue. that as route of make seen well clinical forward

patients that was additional to generated data therapeutics and and gave we've obvious CYBXXX, for it better we although profile us maybe focusing important. access said overall a on time, it profile important is meant transition things became with for scalable of better those always IP. that the improving clear, patient believe product we the some that, as along better that that, is that ultimately So us thing, some And preclinical

that to with human up an coming and So in CYBXXX moving are this next into quickly, quarter midyear. we able great forward move filing studies it's IND just so

Michael Okunewitch

in make start not a called And I Phase wanted will cohort as I more, need just in sure, on patients? Or I/IIa, an safety healthies? of point color. you to but the have study the appreciate additional just will one I this, MDD I the might clarification then

Douglas Drysdale

time, be to expect straight with we regulators, subject to in point the MDD. to this move At into patients able obviously,

be collecting rather than necessary, to PK approval. IND to caveat, from expectation. I'm be patients So the and volunteers. but current give you That's would directly healthy that subject still we'll the that safety going data, the

Michael Okunewitch

you is that the see could if But year-end, correct? case, by efficacy Yes. some preliminary

Douglas Drysdale

coming that. shortly preliminary think see PK with and least at safety after by I we'll the year-end, efficacy

Operator

There registered. questions no are currently

hand So over the remarks. conference go Doug, I'd to Drysdale ahead. back please for Doug to closing like

Douglas Drysdale

Thanks, what think everyone. And cope on pandemic. our of here try a for but COVID-XX is really with as as this we're Thanks it's I you, the Thank focused global We today. talked crisis. mental we and society, effects about programs, the the addressing Billy. paramount and health time continue widespread lingering

partners out and ecosystem we the regulatory quickly with best patients patients, Our for is, and we process ultimately, our move internal as top as ensure that can, treatments. always access work been, to and mind. development combining that of effective more team, of so can the in an to with carried deliver are psychedelic-based desperately scientific external has through team, of We're our our compounds need

you and safe. for stay today thank joining So

Operator

the That Inc. Cybin concludes

Call. Earnings XXXX Thank Year you for Fiscal your Quarter Third participation.

now may You disconnect.