COMPASS Pathways (CMPS) 13 May 212021 Q1 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the COMPASS Pathways First Quarter 2021 Conference Call. [Operator Instructions].

As a reminder, this call is being recorded.

I would now Like to introduce your host for today's conference, Stephen Schultz, Senior Vice President of Investor Relations.

You may begin.

welcome today you, XXXX for and for thank results operator, us joining our you, all and of you call. Thank first quarter of Pathways. name Relations my is Schultz, Vice Again, Steve at President COMPASS Senior Investor Executive And today, George Piers by I'm Chief Officer. Officer; and Financial Goldsmith, Morgan, and Chairman joined Chief a today's our update recent progress. will begin business George call with on And Piers financial our results. will follow of with a review

Investor the being on had open our then We call website Pathways recorded the earlier issued will will The call. is press to results the We call a after available and be COMPASS the review conclusion Relations shortly questions. release today. chance of to you've hope

March described SEC. Form beyond those or by X, and the forward-looking or differ as on our results COMPASS's risks, statements Securities various everyone neither and and Reform result call we forward-looking on risks as including implied meaning guarantees, on risks within unknown and under made they XX-F subsequent call a COMPASS are during you the the statements of team in Exchange the Act uncertainties with other because any on are those amended. which reliance the statements, The promises from factors, forward-looking forward-looking Before undue and not remind control. in uncertainties heading today, these should Securities uncertainties, Private of nor many Actual annual of and place filed known Commission report Risk materially this statements let Factors of U.S. and events begin, XXXX Litigation that will with me the the by expressed filings be making involve could

date. today not forward-looking update represent any as revise as only Except obligation disclaim statement. as relied and subsequent to required as views these forward-looking on our of law, by specifically views any Additionally, we should statements representing our or be of any

Goldsmith. to our call George Chairman I and CEO, hand over the will now

to everyone. access Over our we enable have this lives. welcome, patient to progress mental And experience, IP, number and Steve, make critical in discussions evidence-based happier and to broad and people this health healthier include with to pipeline, experienced quarter, and to in late-stage of continued you, takes programs, which Thank areas, mission and building development a means accelerating executing towards To achieve good innovation clinical of live an us, enhance a digital past to payers, regulators goal leadership. patient the this care robust expert team. active capabilities and

each of Let me go these. more detail on into

regulators psilocybin III in we and patients already recruitment phase the therapy Our trial pending therapy. results with to track for depression, trial. year. the far are treatment-resistant clinical to end to as Phase on for data line or psilocybin plan IIb top trial Phase report We're of to COMPXXX of the expect XXX rapidly is approaching Trial know, of TRD, design IIb move is working our date and Phase as the by largest into we that our completion,

matter for of of dosage oral Earlier formulation polymorph methods high-purity of COMPXXX and composition this further crystalline the psilocybin MDD, forms depressive covering or major and crystalline psilocybin we MDD. and this treating X in patent received grants used disorder, U.S. quarter, methods with a our of treating

the recognized the U.K. in Our States, patents, including and innovation United been X Germany. granted X now X in has with in X

for College by published the with action of including neurological in report exploratory data, London. at Journal England designed patent how when the showed COMPASS study supporting to The many should activity positive escitalopram studies and month, be aim was signals course and a drug The is used of New escitalopram, our psilocybin studies number COMPXXX of X-week of study studies. The in findings psychiatric using in concluded is with data substances from larger COMPXXX compared TRD MDD. explored of College with psilocybin chronic including the first further our is we indication independent they conducted of Imperial program. of active suicidal COMPXXX, and X ideation. SSRI the cancer, signal-generating Imperial can study covering that conditions, depression a and development severe study to that in of treatment autism, X have studies applications investigator-initiated provide into in an MDD. Last and need, a signals study mechanisms move compare bipolar a unmet further range and investigator-initiated of of disorder, the that explore and an efficacy disorder, are research COMPXXX number investigator-initiated body Medicine. also These of clinical for quickly MDD, This anorexia, of TRD We using areas and was type team a cluster and psilocybin dysmorphic headache, may was psilocybin

last completed studies program XX also preclinical new well, Our more underway. year than with is currently XX and studies progressing

on This joined team, research needed In enable psilocybin late these therapy. but entire portfolio journey. a led we of is the us Jason new compounds center, enlarge at us the the Pathways been COMPASS the Dr. Our welcome licensee receptor, its psychedelic generated. we accelerate gives implicated mental it want efforts. will in thank to targeting brain researching to to early financing. and Sciences discovery illnesses. On compounds X-HTXA to the receptor behalf has will exclusive priced This new broaden and that a of COMPASS additional University continuing health beyond is Philadelphia, funding for I all who the optimized by be our new in work stages, believe in is this Wallach and April, expand us our in have resources investors

as to continues The COMPASS leadership position. grow build on team we our

technology to our efficacy prevent building care help believe provide rapidly are of the applications and scale, experts and accessibility are deterioration pathways predict We technologies developing us in digital that and We to relapse. a enable health team deliver improve to therapy personalized could who at safety, will researching and therapies. and these of mental

welcomed than experience more College and a of of Sciences President is Administrators. academic academic, the to a Medicare of XX we Directors. Wayne dedicated also physician Riley the Brooklyn. clinical as of has Board University of the of and of to currently care quarter, of of President serves Payment of President of our care and member the elected U.S. career Advisory American health improving Physicians patients This Wayne Healthcare. medicine Commissioner is Emeritus a of and York Wayne of Chairman his State the member Commission Health of HCA services. J. Board to years Medicine, primary National has Board Dr. Academy A University and He an encompassing Downstate New of New an the of Medicine, Medical U.S. Academy and Society the of Directors York He the

the talent of will hand forward his We more Benedict are XX for welcome update breadth also organizational We're will of years resources, results over benefiting Anne an our our look I than thrilled that, as Anne from to and in experience. to experience delighted now development. With Chief and Wayne of financial Piers? Board global to on brings our have human who to quarter. give Officer. Piers, you People

December George. and March equivalents The position, compared XXXX. you, with million cash at $XXX.X maintain of million XX, strong cash XXXX, company with Thank a continues at XX, financial to $XXX.X

fees noncash compared the share-based ended share-based expected fund operations $XXX We million $X.X additional $XX.X The to raised amounted for our months million X the the prior and through period. underwriter X recap compared operations ended with also ended XXXX now XXXX. I for of for March expense for expenses. This XX, is noncash compensation months XX, to financial XXXX, The the prior before recently the in of period. March from year XX, March end results operations $X.X million XXXX. X an will compensation from million $X.X included the million with months loss loss

primarily personnel $X.X development the regulatory million in expenses $X.X primarily compliance expenses in company. of XXXX for was the and an increase research compared administrative functions amounted quarter primarily year expenses expenses. General with first of This the public the investigational decrease activities. XXXX which $X.X psilocybin prior development. And and primarily one, an The XXXX. in mainly the administrative digital development increase costs, $X.X development an with by in period increases expenses, Two, which Research in first expenses, for in the million a increase of our million first increase to, trial compared noncash an to personnel with in offset of four, other including of and increase $X.X share-based compared of general in attributable of million XXXX. million million quarter of of million additional firstly, with consulting in $X.X transition to quarter increase in compared support and our an and $X.X $X.X of was $X.X million same related Three, clinical in increase in COMPXXX million, administrative clinical and $X.X a for personnel and preclinical an therapy decrease growth our supporting $X.X were to: expenses, relates million to compensation. a expenses, was million to studies increase attributable year period initiatives, primarily commercial to general, expenses prior in

share-based Secondly, an million increase compensation. of noncash in $X.X

year million and and increase insurance. Other Thirdly, exchange attributable a with in million fourthly, corresponding to $X.X first professional quarter of to: exchange primarily of with income income for amounting other company; gain operating $X.X arising $X.X XXXX. prior on $X.X of first $X.X a net XXXX. other foreign an of in associated on legal in exchange the foreign XXXX loss $X.X and related of minus a income with for The an other of million primarily the million including million from firstly, public in the was rent, quarter the increase with amounted expenses in expenses, compared as of of million in quarter million facilities compared to the period depreciation in compared fees and foreign increase million first a to of XXXX $X.X movement $X.X

on benefit million dollars of plus was of [ which XXXX notes, And other $X.X related compared of an amount of to XXXX. increase the period an reflecting million expenses, corresponding movement in the in primarily first for $X.X quarter first ] the million of XXXX back compared of in George. a to same the million net of a Secondly, quarter value of of convertible loss from a fair $X.X with you $X.X with increase the in an nil thirdly, hand $X.X XXXX. $XX.X was $X.XX with the period R&D net loss loss $X.X million per million first credit I share $X.X loss or of that, $X.XX the in The compared during million XXXX. And per of with million in to net quarter or loss tax share

advancing in health Thank believe that therapies over the you, progress for our few position mental months Piers. reflect leadership evidence-based last We our care.

have and psilocybin program research compounds into faster, We digital resources to even clinical we to our for and intend to move to therapy novel new expand COMPXXX indications psychedelic accelerate the of development preclinical to continue develop our look you for and programs in solutions to the We that, reporting for improve forward COMPASS. With your time interest will for experience. on line Thank questions. the your other Operator? now in patient initiatives ahead. we and open these months to our today

Instructions]. [Operator

comes ISI. Schimmer from question first Our Evercore with Josh

refresh to COMPASS on a your field? and think what first-mover do come emerging, drug plan And how makes development I advantage? of this Starting a in unique other see good for maybe retaining time maybe it's number psychedelic to and you companies back us,

Josh. Thanks, Appreciate it.

today's are the discussion differentiators things that our key with. started we think I

We have a program. late-stage

have We IP. robust

expertise disciplines to medicine, pay. their make required but ability We this to to also across available a the regardless it develop as to accessible have only patients of and not team all

before sure company. been strongly actually those evidence-based have And of And and technology integration of we care I evidence delivery because working with have therapy century as think them are excellence, relationships as innovative we've that we'll We past, to area. the are XXst since because at and our that of in was progress medicine a strong really the generating an in looking the in includes to we regulators continue make well that research company with announced payers, and the company. the centers models and beginning make

items And think have Additionally, most additional to very gives mentioned. indications we I on did, well all we now with the given those funded. ability are pipeline execute, And we center. substances additional demonstrated and think I discovery we're can, just financial helpful. the that's that us we've that importantly, I hope the as in of fundraising I

the fragmented see It is. in ultimately of psychedelic centers you dialysis more be we might Do consolidated a expect entities, to like group a setting? group or

need relative to more unmet goal different I is And in the work of dialysis, future. it scope group. many think those with to see a we'd the as given types the of our expect to diverse

Duncan comes question next with Our from Cantor Charles Fitzgerald.

the was me. good George And could England the if of you I Imperial article. and kind away were congrats work. in and I'm only also wondering the from could share any prospective team, Medicine from on in conduct terms on that you the wondering that New your you mentioned a data Journal recently, X progress. it College just trial more had -- if you I'm the perspectives for you? design, or not builder whether learnings for And impacts of What way. of and not the trial, that came takeaways but strategy

trial. I this so much. first And independent thanks think all was a, Great, investigator-initiated of Chaz, an

approach strongly really to the team they do the have how design, we believed but didn't in and we So things. with anything

for continues the patients been data. investigator-initiated it this that seen depression. suffering the the that relative even us, with for other found -- be It we've promising to studies think leading I signals psilocybin escitalopram. trials we SSRI And trend in encouraging to have in shows

fully detect to that. powered course, the trial of Now wasn't

and have verified are our including on there to of is X that different lot failures. was a quite number things -- our population. trial those to different we patient differences referral So it's that mind, This medication physicians, trial, of by in a Phase X a focused II keep between

come decline seen people we out They of I others. XX-milligram trial those So use in symptoms endpoints a was durable there And and that did that saw depression we've number immediate pattern for use our a this think are what in a we the are quite of But same MADRS. things, QIDS, that dose. different. having that's

at has Journal obviously, results, we of Now durable -- trial England But did a right weeks. look IIb in the single impact in what the that to New dose. have and this third dose doses, trial the before happened X Phase a was we our see second the trial -- there the the X when

we're the -- us design. gave that encouraged So around

I think as on as forms our focus be looking depression other stay perhaps our but a of place to that committed we'll we move -- we terms TRD we start, approach, at to in of forward. difficult-to-treat

you'd so And that, don't follow-ups, that's core. ask. to know I of if kind additional like I the maybe think there are

helpful, good, No. No, that's very George.

guess think that I'm study So this working signal. Phase be. that a position or the 'XX, mentioned provided within IIb. the then, design IIb about you good know by wondering Phase little would Phase around that be the clear to But if signal-seeking a reasonable wondering a time, are you think to about actually a III, frame guess assuming I you'll of I III midyear I I'm say, Phase in what premature operationalize as design to a out in time you data a that and is a ask

that's think question. really I a great

innovation. access is So to evidence-based know, patient to mission you accelerate our as

means of tend do we lot forward lot planning. accelerate to that to and concurrently do things a a So and us,

with already programs have what with we Phase on we discussed obviously, contingencies, So see depending regulators. would III

And as approaches as with Our be focused much that and very all is Phase an our of goal countries. in on of in is III part to the FDA, other whole meeting similar quickly II bits Phase end team for then required the means very possible.

when as to anticipate results have the important quickly possible. variety critically is and but our ready as moving IIb the from time trial go design, to Phase are about all we're right. a of that tried inform think those I So Obviously, scenarios we've the to

regulators closely possible. as and our think execute I early that do So continues with we to with as ability more just

as the in feel approval that to simply we best our because, that regulatory way, make in that how we you patients know, to we understanding line, the also the seeing strongly possible. starting need be payers By accessible is include really to way this

Phase a And even as II, looking is Josh's Phase touch health on have in question the really for as requirements back at well. economic III so us. It our differentiator we in critical may trial,

I the George. Thanks good. added like Very it. for Accelerators. color,

question from Cowen. with Ritu next comes Baral Our

about if ongoing safety safety of there's Phase that follow-up. I've you've observations date? going by start I wanted the been conduct just you the got dropouts And to any and the seen about IIb. Can to interim have how And talk asking a looks?

Sure.

don't dropouts we So forth. disclose and so

progress the and has haven't We're we study disclosed of our as would end hold it been that, happy I'll but we to so that So made imagined, just have as the proceeding leave with that. very reporting time-out. well year ever we've at

line think of I -- data for the data. that the top of the X

never when population, as There's work think expectation. of to been we're trial, our our we from I protocol our we we things within the this any requirement SUSARs have why part or And have they're is this of suffering. we make here be huge are disclosed, -- regulators look address expected. for them. the are any in what to It's just those changes well to this at need unmet sadly by DSMB seen doing to

this emerge any that So we unexpected Did first question, safety have had population your our reviews forward. Ritu? nothing for of going answer in

Yes.

So III? that's I measures TRD wraparound, to health and ask about be wanted of the data? been is implemented reserved that potentially top care this have in digital also something when developing you will hear that to Phase as initiatives MDD. guess, the you're that line for any I going Phase there Are IIb Or management and some about we for

English-speaking partner have do small our disclosed in with past, data. in a -- of have partnership we we've patients Android have provided a the did portion a using As territories and Mindstrong,

to as that have, team. will our people will we've IIb. those some continuing in our be pursuing and joined of disclosed, part types we we endpoints. and They've also that of be package the exploratory on able company, been of So Phase have And working exploratory

I - that. many at XXst you the think is century. think, more We're more And of that endpoints of progress. there on be make disclosing paper a currently look as as new and XXs And XXs. used pencil, are in developed obviously, are developing and here focusing the I we measures know, developing to the in opportunity being broad types we'll that

can X question, in. if it. Got last I And it squeeze

use and as high You only more around it's if portion of you patents. behind give for patent strategy methods a that around George, And Can polymorph, even filings the you comment? mentioned composition believe, method polymorph outlined, level, issued as just the there lot -- methods. you mentioned of the a well us, I then detail the other other polymorph, of little

When you say methods, that other are specific things you about? you do inquiring have

guess, disease MDD or beyond strategy I states, I it's potentially, the and Specifically, wraparound support. whether the TRD, around, guess, polymorph for the psychological

Sure.

think a couple things. of I

So probably X things.

is I. MDD, we have need unmet high what first and are very set robust I doing Phase we're Phase work We moving studies, is TRD of The beyond as a areas spoken. address to looking we've then into obviously that preclinical of and

So forward those in that in that move looking at we're area investors provide -- we everything how way in areas. is to do will doing confidence that a

sure focus, important to make the absolutely is the importance as that that's aspect support part terms specific how In and well do really think to looking demonstrating always that as this there's done And which therapeutic of developed. of done the of things done. protect our that integration our again, And focus molecule. we've I we patients I on everything years the about work at been been that, has when so much application, an the wraparound, in we've we the talk important been, of over think its for of like polymorph we have become

furniture, some of out media these any our make to any patent always this, individual And decor, I comments. particularly into for cycle applications of are commentary. so forward a -- have also to that safety attempting music or and listening in to make some room for we there's very pulled as really patent matures as items life patient important our the been to been record, social sure context way outcome. connected that soft not things been want and look from We're clear of those that's But aspect

way a So chemotherapy would the this forth. and addressed is just in syringe a be so patent

Ritu. do question clarify that. want So be clear as Did so about your just your question? I I an that, you, thank And see opportunity that to to answer

Yes. it. Got

next with Our from comes question Sumant Kulkarni Canaccord.

here. few I have a

interesting potential Phase So ongoing and already mentioned you that one, the regulators early in steps. the might to IIb? on this And Does you FDA? these way trial thinking you've be relative designs share could findings new, COMPXXX's different about that's or anything with engaged regulators include first your any next specifically

breakthrough we So -- designation. therapy are we have

where you conversations value way and As add with to those regulators can continue. a to know, program. And we they Those engage seek meetings our in continue.

the we there's So perspective, have from to my nothing additional until share results.

that with looking the are with huge help might anything they're see go in patient they quite for they're think accelerate unmet these of everywhere I conversations access constructive. the need. to aware Obviously, we regulators that areas. and payers And how to

Got it.

be limitations way Given considered over of that more of may long thoughts psilocybin, the the to And integration COMPXXX be evolves, have what of COMPXXX as there latest on clinics statutory administered? that potentially sort some may duration not your are forward into the action adverse control on events product-related? the which program beyond note, is

regulators, given after, think do you really regarding and that our forth, it it's trials. term and long [ wrestle so ], even with, is have or to weeks a one. them durability. actual we'll be first then discussing that So psilocybin and not. some question, interesting People this in with I seen the to situations so X And the we've It's be could -- we obviously, attribute of life

question, from answer related one this on a But at your won't And be we'll say there's certainly discussing. trial I durability that that kind definitive second any a think I given So single area, this is new long to point. and sorry, I'm of Sumant.

clinic. So integration on it forward into was

it's have -- very working how could work, much sure we're that reimbursed. how think make to on I that

Phase on. get want go we a at is And to obviously, sites, Phase our we're our to smooth going the when that path continuing there infrastructure, III implementation. to we sure glide to that's we're broad closer III very whatever make look activity doing that's So very,

Okay. that pharmaceutical And any property. to have include do would synthesize they possible last X chemistry it not and activity? is my of formulations your Is And specific on question a intellectual even psilocybin polymorph?

that can't again, say, chemist. let speculative would not me and a question, my it's -- answer I part, be on I'm

So the we're that done polymorph, protecting but in we've can't able for or what comment confident others be do to work do. our might on I

next Our question comes from Esther Hong with Berenberg.

questions. I've got X

into first, studies. ongoing I the dig to in So academic administered Phase wanted deeper of study, doses IIb the versus number

So studies, the decision which And X administered more studies? can with COMPASS follow-up. are of a that those to understanding academic in you provide IIS on I've details got did some design then versus single move a not forward dose and the doses,

questions. Sure, Esther. separating Thank you the for

order patients. first you to our this this payers really, is regulators get in mission, closely So accelerate to and work back question to and to with go if evidence-based it's to innovation

unanswered So to using questions really a some on this patients. theme, need focus getting that as be that to core to there were really order in answered

do And the variability. huge prior is them, high in perform because we've second -- seen we is the of what how One ]. saw this studies, our group the And all dose? really [

development, Other they then months we people sure a long that who our socially some It's to think I people longer, and report, respond. And benefit. single from how responsible people responses. have they make go doing and benefits intermediate dose. don't obligation Other for understand even in

stewards way dose that single then there's question tracking and a and doing health fundamental over so good so without answer so that resources. to of ] be And we can no people time, [

and chose will do investigators working we that. the ways futures to this that this other companies of add our in area. future in Obviously, exploring to are So other

So But really it's explore. as to responsibility. for us, this that they our bring is good this we patients,

is patents. Got question then the on And Great. it. also next

So a granted now X on has the psilocybin. U.S. recently X in patents granted the dosage an oral of company form including

So form best indication I was be what this used? could wondering

Sure.

and administering of ways of variety exploring we psilocybin. indications a are So different

And PTSD, so disclosed plans, investigation just we're area in our difficult-to-treat indications cetera. that protect looking into to of go this MDD, as is that we've at of we that other in terms things et

for protect just areas those this us. So helps

other And management to to call questions queue. remarks. like closing there's turn for no in back I'd the the

much. support very We're the among investors our for you our grateful analysts. Thank really and

possible. and hard even are issues And this we working health as accelerate very pronounced. in evidence-based commitment to healthier mental to to happier innovation becoming, our that people these as in patient COVID, bring retain to health mental suffering, are more clear and Thank access It's lives. you. help live patients We soon post to order

participating. call. today's Thank conference concludes Thank This you. for you

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