CMPS - Earnings call 3 2020 | COMPASS Pathways plc

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Operator

Thank you, operator. Good morning or afternoon to everyone, and welcome to today's call to review COMPASS Pathways results for the 3 months ended 30th of September 2020.

With me on the call are George Goldsmith, Chairman, Chief Executive Officer and Co-founder; Lars Wilder, President, Chief Business Officer and Co-Founder; and Piers Morgan, Chief Financial Officer.

You may have seen the press release we issued this morning at 7:00 a.m. Eastern Time. results as X update. well financial of ended our XXXX September as includes for months the XXth It a business press available of also release Investor The section Relations on our the website. is

being the X Form September are SEC Our results filed months the for with XX, ended XXXX also X-K. on

a today's quarter. our our financial for update the recent a progress, George will business with of begin Piers review call with on will follow results

approximately the expect We minutes. will recording call the is this call recorded, The shortly XX then Investor call. last being to questions call of website the will to and the be COMPASS open and Relations conclusion after the available Pathways' on

Litigation be forward-looking team During the the the call XXXX statements making today, as amended. Act Reform of Private meaning will Securities within of the

statements negative these In intend, should, would, be forward-looking predict, potential, ongoing some will, not words. although terminologies continue believe, estimate, statements identified other expect, might, may, all contain such contemplate, of forward-looking these and can terms the cases, or as comparable could, terminology, plan, anticipate, objective, by or

this or uncertainties are The because are on expressed these involve many implied statements activity, actual results, by performance and forward-looking and unknown factors, levels which beyond undue those which these of reliance call not statements of neither materially on forward-looking guarantees, promises differ or they and known you control and COMPASS' forward-looking other should risks, nor could from cause achievements statements. to place

or in September www.sec.gov. which SEC's trials and the with the those include, therefore, the under SEC, prospectus the delayed terminated COMPASS and of subsequent Exchange are uncertainties heading, with preclinical Factors the advance and website development clinic. lengthy and is available Commission other in XXXX, be at our filings described may by in XXst and on clinical risks made filed Risk or never factors U.S. Securities clinical COMPASS' and and uncertainties on among And others, or risks, and preclinical to These studies uncertain, may

or responsibilities expectations required only conference Except as of new current by forward-looking any revising statements call law, COMPASS' made speak These information, the this event date future otherwise. or statements updating on based the and are of in as hereof. any intention disclaims developments or forward-looking COMPASS during

And Goldsmith. over our with will I that, to CEO now Chairman, Co-Founder, hand and George

George Goldsmith

Thank you, a first as update publicly Tracy. everyone, Welcome, to our traded company. call quarterly

earlier proceeds we an gross know, you upsized on million. of in As IPO the year, NASDAQ and $XXX.X completed raised

the began depository Global American of Select Market XXth NASDAQ on September. shares Our trading on the

be introduction. a may give COMPASS, accelerating few is dedicated to a take access to health a care to you to of new I'll in mental company some health. patient innovation minutes brief As COMPASS evidence-based Pathways mental

the on by are and treatments. lives Our helped improving health are with not of suffering mental who challenges those focus is who current

depression. new of and has are Food by COMP We psilocybin, in for psilocybin of synthetic XXX model designated of therapy our COMP or therapy conjunction the treatment-resistant development XXX, FDA, the administered Administration, psychological pioneering support. in formulation with breakthrough Drug U.S. which a a been proprietary is

to Phase and to a psilocybin IIb conducting clinical currently of for treatment-resistant depression are recruit We plan trial therapy patients. XXX up

As making this are we with release trial. we our progress earlier in indicated steady press today,

hold With in month. on new addition -- new this Berlin site Berlin site the a just second. of in X The

and trial XX have North now will XX Europe sites in We countries America. across

from trial, late report our plan trial has the data remains this XXXX to COVID-XX impacted While our pandemic in unchanged.

always situation closely else. and assess the are with will ongoing our our COVID-XX of to We sites patients and safety everything the trial teams put carefully working above

welcome were leadership team. Board. strengthen McGoldrick to In September, months, the delighted to few last the our Over we Linda and we continued to have Board

Health Financial Zillion private and experience health range life organizations, and Permanente companies brings from a public including plc of and Inc., International, care and Associates International. Veos Kaiser sciences Linda nonprofit

In Vice Information Digital week, as Commission. Research. Machine Health on the Data Governor of state's to Learning was to our serve President, the this Health appointed team Earlier Science, we by Senior welcomed and Technology Massachusetts XXXX, Linda Greg Ryslik

and scientist is intelligence artificial He Mindstrong Greg at Vice held Relations. at join core mental future the tremendous us Continuing Schultz instructor XXXX, team. will in and Tesla. an of be expertise Stanford and Senior positions and to add will a senior X digital to care, Stephen President, and health Investor health Greg at Digital digital data our executive. December, Studies has will is technology as

from the experience quarter, us Vice Founder who GW in CEO and Digital Pharmaceuticals. joined our Steve Investor formerly Stephen come Sarah management Relations off Actify years hires, has President, round senior Access. us was Lavin Steve Training, Patient to Research Head than To Ieso joins our and Officer. more Neurotherapies. Chief Bateup, XX Therapy Clinical of in earlier And as appointed from is she Health, at and having was where us

enable entered the The A is August, the portfolio Sciences to therapy. been psilocybin brain that to to the agreement targeting in a receptor. we and sponsored the implicated X-HTXA optimized developing in center is broaden This into its mental In our stages but illnesses. has early compounds center. receptor with Turning discovery in us exploring work Philadelphia of beyond drug will health developments. other research University a in also establish other and psychedelic

course, the is, primary development on Our of psilocybin our of focus therapy.

were patent patent medical In uses utility second includes patent, U.S. crystalline to granted the pharmaceutical formulations, and and psilocybin, our model. method manufacturing. our July, we The German U.K. covering of claims adding

review for subject patent of U.S. petition post XXXX XXXX. was Our granted in February a grant filed in December a

dismissed on August. in merits the was petition The

or of partners in our use and to to provide psilocybin with XXX academic for other number COMP to a independent continue accelerate their studies. We work research

HealthCare, Rockville, providing example, Cancer Grove the funding are Medical Center Adventist For to in Shady we and Aquilino Center Maryland. at support

patients. launched administration cancer Aquilino in psilocybin of and trial August, one-on-one with treat clinical the the to support In first depression therapy patient team simultaneous

could milestone in one-to-one important an trial to that. and And support developing with administration trials this potentially for clinical is accelerate patients. help Simultaneous access

psilocybin session administered first successfully administration The last was week.

-- receiving one-to-one therapists. a all psilocybin patients have We combined support with specially with from

of joined mental Psychiatry companies an to needs Consortium, charities medical the we of unmet collaboration international pharmaceutical earlier health this identifying address of challenges targets people living and drug conditions. the with the month, novel focused on therapeutic Finally, validating and research

We in XXXX. community alongside call support calls from seeks will psychiatric work proposals commercialization academic psychiatry projects, for access Consortium expertise funding, providing and through applications. biannual and Psychiatry consortium advance The to global project January will open for open research the research via members applications to next know-how. The partners

care of well-being. our a are and mental company, world We health is vision a mental

mental do access the world XX seconds and any do Every people crisis And options. of time, in to from not the millions in We to suicide. suffering attempt challenges mental urgent same someone an facing people health can are who in are help must more XX care. and have health suicide. dies We that with

that, With the will now who quarter. to on will Piers? you I financial give Piers, results hand share for -- update third over our an

Piers Morgan

George. you, Thank

As the $XX upon X,XXX,XXX completed our our or Select expenses. the ADSs, of upsized in exercise on of their full deducting XXXX, of XXth by million September XXXX. ADSs underwriters shares This offering oversubscribed additional American X,XXX,XXX ADS. trading were a began underwriting we September George IPO and Global price included ADSs which discounts at option ordinary NASDAQ ADSs. after proceeds per issued mentioned, X,XXX,XXX represent in $XXX.X depository to on IPO the The of commissions Market and the additional from approximately The purchase net shares,

June XXth compared held of September $XX.X of of $XXX.X and XXXX cash We with million cash equivalents million XXXX. at XXth at

to This and is expected to XX, I fund XXXX. the share-based ended will compensation XXXX. of the months compensation million period. X expense X to year from noncash year $XX.X The XX, ended share-based September operations September noncash X for operations XXXX, $X.X months our compensation months from The million for compared loss prior recap to loss from million share-based million period. compared for compared compensation the months the in XXXX, loss $XX.X for the This to XX, included XX, $X.X X now $XX.X for into ended ended for operations million of for the amounted prior results September September compared to months the X period. financial share-based XXXX, loss expense operations million period. noncash, in operations the September amounted XXXX prior $XX.X XX, ended X $X.X to from $X.X million included prior noncash the The million of

related XXXX with to personnel period XXX. as Research increased development COMP the quarter primarily the increases associated and expenses The XXX were million other and the compared for COMP well third for activities to million development development costs was share-based change support as increased compensation in last of to ongoing our year. of $X.X $X.X same

with exchange for compared XXXX, administrative Research expenses period during period the September and ended fees, same were and million million million were $XX.X for an to for XXXX, in XXXX, higher and and the $X.X of XX, of during $X.X amounted compared XXXX. net was The as the $X.X ended in for to personnel the in in development amount Other in corresponding $X.X legal months same with same compared for million expenses months XXXX. foreign compensation XX, XX, translation X $XX.X million period the the related consulting X costs. share-based to General impact XXXX. related General the third to XXXX as items balances. rates the cash September nonoperating on and September primarily and to professional the of well $X expense the X quarter expenses $X.X of compared income ended million administrative movements million facilities million expenses an XXXX were months for expenses of primarily increase period

the income the quarter XXXX. during compared for expense for $X.X the in same share XXXX loss $X.XX per million loss of period with million And loss or XX, in XXXX. with XXXX net period of during in or million $X.XX $X.X loss loss per The the or was million million during with other same net Other $XX.X $XX period months share third $X.XX X share September XXXX. XX, September per ended $XX.X was million months XXXX, per $X.X X or the compared ended same loss the compared $X.XX share of the for

line operator. And now Thank the will you, questions. open with for that, we

Operator

Instructions] [Operator

from question with comes Cowen. first Our Baral Ritu

Ritu Baral

timelines? just paradigm question might the you ask then Any and current be or new in I I protocol recent trial a II your follow-up of I dosing wanted -- thoughts incorporated current dosing dose is the JAMA the paradigm, Phase your that that in I'm II. whether and in clinical trials. different into the than COVID be on Psychiatry, to additional wondering the modifications you about psilocybin publication trial the think that further, the considerations ask with forward on were impact adding wave? might Phase to wanted on to the seeing COVID And how

George Goldsmith

Sorry, me? I I will -- apologize. to that. you plan report I can take hear

Ritu Baral

Yes, we can.

Piers Morgan

We can hear you.

George Goldsmith

Okay. Great.

with really plan of as team, patient. report and to remains continue by subject impact all this the no to XXXX steady new can assess this mentioned. Safety We stated. at with months, trial But ongoing data wellness we're as situation COVID, over trial carefully sites and point. which working late Berlin, unchanged. do We're last everything I our above to the of one a Our COVID predict site closely progress in I to obviously, else, safety and the opening is make the

terms XX study countries, regulators in firm of of dose some on a the The sites COVID. So tolerable really headline important our protocol report that's and stand terms IIs with both developed JAMA sides response sites out. be Phase of the with recent increasing very questions, of We durability current a to so it will because Atlantic, the in current our the including most XX carefully to for single prediction the dose. in the answers the we is that used

be really that developing to see that's looking paradigms dosing different psilocybin because at then therapy. we as foundation actually don't required Until a have we information, regulators reason for by a

Operator

Our next question with Evercore. Josh comes Schimmer from

Joshua Schimmer

thinking medical threats may reminiscent about for marijuana. efforts this the ultimately other are to trends psilocybin to that are saw, therapy COMPASS, update? you a medical of states What are so psilocybin? is opportunities And or little to legalized legalize grassroots you the the present How Oregon if aware of we any? The as update legalization any

George Goldsmith

for be to explore that. So and this clear, X-year actually process is a has starts period passed the X-year to will conduct to it developed, that so options what be designed so process effectively been now

enough I for think goals options. for conditions of mental who aren't well simply those point we in the general, the need legalization is from health treated enough view, we both those involved long-term our this, of which new efforts in people who that share but voted and

that. So we're in agreement on

to of simply What that regulators and pay the for therapy, And I evidence that and on it's really met number sides our safety very why we've of doing isn't important according a also think trials. Atlantic, Oregon large the on with both regulatory There which it's yet in enough is we agencies. who of would clear efficacy not psilocybin the is of therapy. Model we're differ

we COMPASS to really agencies ensure approval or is that and efficacy developed So best as therapy. through designed review regulatory way believe we've the any and quality of medicine and the safety, the

quite standards trials XXX to therapy. developing than depression. XXX Oregon. psilocybin proprietary at of formulation medicinal with meet the Phase and different looked As COMP clinical therapy such, are a currently that's COMP therapy IIb is we're criteria quality the being Again, psilocybin running regulatory developed being for associated treatment-resistant for psilocybin what's through for therapy

our therapists who trials. our of FDA the going provide then patients to to safety And patient to our licensed lastly, training clinical are support commitment includes in approved

it's I number a think there are So of -- quite differences.

psilocybin available We regulatory that we're system, that also that it's clinical way to of safest health the we it. most strategy made is committed prerequisite those believe to if route This into who and regulatory and benefit might all get are to approval and believe evidence for access, approved means consideration. reimbursed effective from reimbursement because the our the therapy,

Oregon So story. that's the

prosecution levels X under again, for I essentially of of controlled is or looked years. in are where other using prevent but which other articulated which at. of people over even being and There Oregon different And carefully decriminalization, these is this legalization think legalization. being in countries to it's substances developed terms various places than circumstances, is these were

a are things. there different variety So of these

In in patients through see work, our to for terms implementing. model of reimbursement and that focus committed that access to its our be a impact we we're continues on

Operator

comes our from And Berenberg. with next Hong question Esther

Esther Hong

the investigator-initiated ongoing. how next are about How Results just studies we over expected So months. to through a few. think program? read studies are There should multiple XX these COMPASS'

ongoing III powering a the details? What bit then about IIb although program for little like expect what many XXX from Phase a next are COMP Can data How maybe assumptions, -- be assumptions? year. bit any bit additional a speak Second, And expectations? trial they're do Phase look And trials third, COMP early, you would you little expected a will XXX? required? the

George Goldsmith

Okay. I guess I will start that.

repeat you questions, could question, I'm first the sorry. So the

counting first question to up was So -- was X. I

So do a be will time, me. one at it easier for

Esther Hong

Okay.

So multiple first question, so there's investigator-initiated studies ongoing with...

George Goldsmith

Yes.

respond can that. Okay. I to

are of regulated. there yes, some for are using of program, not. are the that So which COMP regulatory was on XXX, to focus product is some drug which multiple going be the investigator-initiated Obviously, trials, any

of will we results So psilocybin be our studies to we or investigational our databases. our certainly of our IIS to the looking with support safety bolster studies closely

and and signals. it's designing not facilitate a early our We that help program, can we are, research again, those IISs, a of generate part it's way

interesting others impact but done have not being are be will by for that it results, may direct any we should program. studies Other on looking our which out contribute to

question? Second

Esther Hong

assumptions, expectations IIb question, trial? Second Phase the around

George Goldsmith

really These changed. haven't

of And expected. changes the recently. only States progress in has it do that's Phase at the has been but at end we been So detecting weeks, from complete, X-point of additional MADRS upper been trial change the of next COVID. United difference additional have as to it limit likelihood to been as X year, been We It XX% the barring we made, no an and made has in the as been powered, which II shared a plan any underway. has have said, continues elimination age impacts change

Then question X.

Esther Hong

look question. was similar a many like? would it something Would what trials? for? Phase to be III How program X, required Question What last

George Goldsmith

It's in on really forecast be in but based find what hard to different Phase we'll needed at Obviously, those IIb. scenarios, might scenarios that. we're largely looking what are

effects, size and this III upon of in our So having we nature about Phase and Phase the and really dependent clarity will really program. I think lead is us what will the see that into II

Operator

question Canaccord. Kulkarni next comes Our from with Sumant

Sumant Kulkarni

have I a here. few

of in we that achieving first stated But risk clinical safety XXX evaluating if to key the trial So pick your a achieve to II such something would efficacy low very to the know that's had you trial and be a ongoing, along your COMP dose? example, in or else, as the efficacy you're one, safety program. lines goals blinding, risk on Phase ability or for

my first That's question.

George Goldsmith

Thank close of both Atlantic in you developed regulators have group with on for We sides very question. TRD. we've people done trials the don't these anticipate the research well as significant of as who a and -- first collaboration

been believe end Obviously, effectively those from and the any progress, that don't -- trial so a what concerns the in have we dimensions trial. is So designed, the along perspective. happened has research the of we of design at we determine are we will clinical

that. I can't beyond comment So really

Am I to follow there? ask missing something up to a -- is there you'd like

Sumant Kulkarni

I'm question. No. for my -- just That kind I'm of fine. detail second is going

interim given is of chance these there to any Phase have prior the look an the going psilocybin XXXX? trials, late that's II to on So nature

George Goldsmith

There always that. our designed been to conduct is chosen that. do it's largely, fully we We've do want And team behind the an is that. to trial and as opportunity not to

Sumant Kulkarni

this question at to support final existing And about is when also infrastructure give How to but to product? the it have it the of this company maybe how it to makes when little the going ask need you potential my the thinking is a anyway. you're premature, I'm pricing will much time to a product launch And center market? like able or

George Goldsmith

assertion correct talk are we and view that any until it's patient about have in efficacy your pricing to premature You response. of

something that's preclinical in trials. as that looking develop our support, at the we to we and training In are do terms therapist of learning

Operator

H.C. Trucchio Wainwright. a Instructions] We have question from [Operator from Patrick

Patrick Trucchio

questions. I few have a

is our focus inclusion and or is the of solutions key think the of possibility just, predicting relapses first I digital on remission. X

where in anticipate XXX the around I'm the IP timing then development technologies? wondering or we the this front we around IP the broadly? digital And And IP So for are those COMP the update should on so, on what's an solutions? of if

George Goldsmith

you for Thank the question.

We clear speak. and we'll that as those we as areas be plans become digital digital but now forthcoming, are are the support, they therapy right and of of developing, will sharing terms developed so phenotyping in being plans be

Finally, in question, terms of second sorry? your I'm

Patrick Trucchio

around the around terms of -- an those in Just phenotyping. IP digital update

George Goldsmith

course. Of

to as our continue will et announce patent that And to as that we we everyone. again, become various grants, So cetera, property developed. reflect it's intellectual in area will visible

Patrick Trucchio

of of And it. in impacting feasibility in go simultaneous administration I'm being forward. ability is administration? administration at simultaneous was study. evaluated plan demonstrated go wondering through to can how development the demonstrated, kind then the Got we COVID COMP the is Phase feasibility the that the the simultaneous specifically how how, and of clinical was all, with if I specifically, as pandemic if the And XXX evaluate you

George Goldsmith

again, then the conducted which study X a support, from basis, setting no That what safety patients were in simultaneous of as that one-on-one uses that receive that. with for concerns now, healthy administration to was And shared is and last emerging work one-on-one was Aquilino could with right able first And that's demonstrate support we protocol, simultaneous mentioned, volunteers. completed administration the week. was So also up session in I first people to submission that as model. the the with

a be population. watching in will patient we So that

please? And so question. repeat second first the that's your question, you Could

Patrick Trucchio

Yes.

that COVID pandemic, the evaluate the simultaneous administration? the impacting is to ability is Just

George Goldsmith

way recruiting would impact I It done would in thing doesn't. mean, specific really which yet. we've again be be experienced there's simultaneous will administration such in if difficulty but assessments, studies, that the no our only

simultaneous So administration that we of any model. and studies link between see evolution and don't COVID

Operator

in further queue. no George And to for the call are to Goldsmith back turn like questions I'd closing remarks. there the

George Goldsmith

very much participating you to Thank call. for everyone in today's

for forward be you you today. participating some in to participation look of We meetings investor Evercore Berenberg and will the there. very and upcoming, we Thank much seeing

COMPASS Pathways (CMPS) 12 Nov 202020 Q3 Earnings call transcript