EVLO - Earnings call transcript Q1 2020

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Operator

Good morning, and welcome to the Evelo Biosciences First Quarter 2020 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Please be advised that this call is being recorded at the company's request.

At this time, I'd like to turn it over to Jessica Cotrone of Evelo. Please proceed

Jessica Cotrone

Carmen. you, Thank everyone. Good morning, we topics issued that morning, press a plan to the we outlines discuss This release today. This release tab. the under is available at www.evelobio.com Investors

Mark financial and our President Officer, Duncan will in call, first Gill, recent Medical Executive Today quarter business our XXXX Simba McHale, Chief of and Scientific Chief Officer; R&D review Officer; results and Chief Bodmer, highlights.

including monoclonal call matters begin, that and milestones statements this facts, the sufficiency conference and everyone results of of Private Act of objectives Securities our within be like to made of the fund relate and remind that about to to I'd not anticipated statements and should Before for Litigation we operations Reform impact studies of do the our cash considered XXXX, statements historical XXXX. microbials of of any meaning timing during clinical forward-looking the clinical any the

Evelo be change. even XX, provided forward-looking materially March company's any Act. the are on the its the quarter the today. company's subsequent statements Any to with the other duty to report safe factors. subject filings impact Securities to and forward-looking indicated for ended to these updates statements and statements today of those forth from disclaims results XXXX, XX-Q operations events speak of protection harbor Evelo's views as the made the provide statements forward-looking Actual directed Commission. set Evelo's the Exchange many in by if intended cause only to due Such risk to are Form forward-looking quarterly to Reform the could to Participants by factors differ

over pleasure my now the call Simba. to It's to pass

Simba Gill

have progress quarter. Thank and review additional good EDPXXXX clinical joining support the potential effective that we report of morning, drug. as I'm first you, in for the anti-inflammatory today to you that an to Jessica, data Thank everyone. us pleased our

encouraging with evidence triple-negative cancer in EDPXXXX. We also breast initial have

for may disease, of COVID-XX. by of for a prevent Phase the last of to EDPXXXX COVID-XX, an able II the announced IND the we week treatment be we Importantly, in submission and early progression of study intervening

We half of year. expect the to study in data this report second from this

to up and of supply we patients We and be we to manufacturing COVID-XX by aim accelerating of EDPXXXX. clinical scale see from onwards. for there responded the in key pandemic a development XXXX and positive for millions If plans product have data, by early to scale to for position

new products. activity of clinical We of have informs the humans data, our generate in also our of formulations continued understanding to which different

the formulation these on in dermatitis relevant psoriasis clinical in now positive our either clinical will enteric enteric results. with results, EDPXXXX into Mark with study newer We Phase expand advancing on not we're human II formulation in X did dose-ranging have our of effects the psoriasis. capsule or atopic meaningful observed separate We formulation. alternate with studies. responses see Based the

to also into and EDPXXXX areas We including in and the metabolism. advance potential to of continue platform explore our neuroinflammation clinical development

the filled continue I our call. and milestones clinical revised clinical and will a in review will be expanded year later to XXXX with data,

results now over call about you me Let Mark turn new with the tell to to EDPXXXX.

Mark Bodmer

Simba. you, Thank

During new past from clinical results comes of lot we've EDPXXXX. of about This studies. the the clinical learned pharmacology quarter, two a

EDPXXXX enteric with the of immunopharmacology capsule Phase First, formulation ultimate the second, from an study with data study. and interim the formulation; Ib

placebo. an volunteers striking an enteric most in end It's either quantitative test study formulation to for objective, to preclinically measure point. capsule EDPXXXX EDPXXXX preclinical effects the the as the similar translates response. to tested of reduce healthy blinded in XX inflammatory whether the the This we ability efficacy. immunopharmacology. antigen-specific with the of a direct delayed-type use studies with hypersensitivity XX intestinal It's start small of models access dosed or using standard were mechanism days and humans I'll of

They were technique injection, Inflammation was day a second laser blood dosing. contrast reaction induced site Readings the on KLH, An immunized using measures called before XX flow injection three by of or was with which again, the compared of the skin measured keyhole feature of the inflammatory key imaging, at on hemocyanin, the immediately then XX. were arm speckle day a limpet of after antigen, inflammation. reaction, an and second KLH in hours.

placebo, in which and year with from and small a humans who in demonstrated individuals is clear-cut response quantitative over Sticking in last the data functions lower XX-fold inflammatory inflammation, preclinical the inflamed proof two and skin shows a the resulted It point. released with flow reduction with clinical consistent and access end of mild using of can intestinal be in systemic of psoriasis is have moderate that PASI we to an scores. XX%. lesion used reduction data cohorts EDPXXXX the objective to both severity the This blood with modulate in than mechanism

announcing trial we're data mentioned, from cohorts interim Simba alternate EDPXXXX. with Phase of individuals also formulation the dermatitis atopic and of psoriasis Ib the As treated

high leading and small not transitions effects reproduce does to a and of capsule which We is drug released gradually the when to The clinical bolus way intestine, drug to in intestine, formulation believe in the high different the a bolus of see EDPXXXX concentration it drug. in the so entire disintegrates has either concentration. releases stomach from formulations. in not the the cohort. did capsule two this the We small do The alternate a with release

be can exposure some from the pharmacology the the of of a response time, with on results, aspect of recognized dependent drugs. total drug preclinical reconciled concentration over This being dose more the maximum

of capsule treatment the inflammatory reported reinforced results clinical to three EDPXXXX range efficacy with formulation and separate of data EDPXXXX the practical a cohorts immunopharmacology dose we now with potential human diseases. in have psoriasis reported are summary, today. evidence the the of clinical showing previously EDPXXXX the by In in significantly immunopharmacology Together, for enteric study for

formulation. will The with enteric hear future studies from capsule about Duncan you'll the be done

to submission for Duncan, scientific for Before you like rationale trial handing tell I'd EDPXXXX Thursday. the announced over taking the last into about the COVID-XX we which to IND

that aware, lead on data fatal. life-threatening are multiple you're inflammation suggests with COVID-XX hyper emerging storm, sure associated be can to I'm As and organ which failure cytokine complications

Preclinically, on with including that with complications in X, IL-X, been IL-XX, implicated and multiple inflammatory induce observed has storm of IL-XX COVID-XX. and of inflammation cytokine Several EDPXXXX TNF, cytokines, of ThX, effect associated pathways, severe mechanisms resolution regulating to have ThX modulates these the broad been ThXX down X, IL-XX.

and study these with effects of date. and mediators IL-X, had clinical safety a placebo-like oral biomarker quarter, product reductions beta. are in announced data Ib that the to in And of IL-X systemic convenient earlier And the in all achieved studies Phase course, including IL-X, psoriasis TNF showing multiple we tolerability from has inflammation,

suggests of potential including as the This well flu. a for for of 'XX treatment as complications COVID as a profile EDPXXXX inflammatory conditions, viral-induced range

me And over Duncan. to with hand let that, it

Duncan McHale

and an I Mark, pleased treatment with to to in Thank the everyone. potential we our next start EDPXXXX you, morning, and for the oncology see update good I'm programs. on for want provide inflammation of COVID-XX. steps the

of by and announced be to with Phase last Panettieri, study leaders Johnson a Rutgers one University EDPXXXX Rey Dr. University the evaluate in week, will Wood the As led Robert II COVID-XX. world's we're in of treatment to for Hospital honored respiratory partner study disease. the This we

is the EDPXXXX prevent as inflammation modulate hyper and clinical on COVID-XX its of cytokines, showing potential the ability to key the with test complications storm associated to multiple has to described. life-threatening in and cytokine preclinical based data, decision Mark The

initially individuals of in to that early EDPXXXX assess the treatment study COVID-related associated clinical the XX progression patients with complications. placebo-controlled the potential intervention if enroll lung hospitalized is reduce a of study EDPXXXX diagnosed COVID-XX the trial COVID-XX symptoms will The will Phase of of that with newly II is The development the double-blind can of prevent determine or deterioration and function COVID-XX. with

of EDPXXXX Individuals include top placebo end symptom for days. WHO's of will or requirement points progression therapy. the primary end oxygen is scale The severity standard mortality. Key study duration, reduced along disease treated and secondary point be total the the XX care on of with for of

The our level And placebo increase dose coronavirus study, from due rate small discuss sample COVID-XX dropout for Simba of and order higher-than-expected we power our a lines in studies. implemented which for the unchanged we in to apart call. dose-ranging the Phase II time in continued apart oncology is tell to psoriasis. from COVID-XX will Now setup each size, with of in buffer on to study to moving to with the of provide patients in moderate have infections. some impact design the later a parallel EDPXXXX to increase mild the trial the

this, we've type. a of As encouraging Because use initial to the beginning for the of prioritize triple-negative seen of cancer. this call, the we Simba tumor mentioned to EDPXXXX the support evidence breast in as of potential treatment at EDPXXXX development decided have

cancer PD-X, a effects of open-label breast this combination metastatic of the Phase a and single-arm triple-negative remarkable EDPXXXX data passed. no designed range hurdle types, study evaluate cancer safety colorectal in triple-negative signals, futility in Initial showed microsatellite reminder, tumor cancer, successfully has and of the relapsed with solid a As PD-LX breast is tumors. analysis stable for clinical KEYTRUDA the was X/X to study

on who will the arms other focus the recruitment are With all subjects of in breast are the currently still triple-negative but we the recruited in cancer, new study follow study. halting

back call now over turn the me Let Simba. to

Simba Gill

II revised milestone trial the on patient initiation COVID-XX guidance size and COVID-XX wanted and and the initiation our I with Thanks, clinical pandemic in and Duncan. its of Phase to ongoing given anticipated impact current conclude recruitment.

effective including the half of in symptoms the EDPXXXX from will also storm, of second evaluating we during hyper influenza. data the by and study II impacted expect cytokine is potential limiting its If explore in in Phase progression and this inflammation diseases year. We COVID-XX, EDPXXXX COVID-XX

the psoriasis initiate third study in interim Phase the XXXX. We moderate of of the with of middle will dose-ranging to year, in this data also expected by mild quarter II EDPXXXX

will of EDPXXXX from quarter of of on atopic clinic treat and individuals we the EDPXXXX clinical half XXXX. Ib this in EDPXXXX in the to advance of and focus fourth candidate with first will group continue We XXXX. to monoclonal patients the nonreplicating expect into we second atopic the either potential the dermatitis. of our Phase data asthma TNBC will diseases, treatment The first microbial product And or trial evaluate and,

our research my XXXX, me forward look up work express to Evelo to us to our you progress and team plans COVID-XX clinical programs to during now enabled as let gratitude during progress the open The questions. We our to further pandemic. partners. and development we'd call exceptional updating and to your we the like has closing, In the

Operator

first question is And from with Matthew Instructions] Harrison [Operator Morgan our Stanley.

Connor Meehan

on for Connor, is Matthew. This

provide data with just quickly, capsule formulation the times, in time and quick prioritizing how the general then how And Otezla you feel forward? release recent Could data your had from EDPXXXX data moderate? lines after the So the some overlapping maybe you in based on impact insight on to expect just mild we regarding just do that two you questions. sets and and then enteric to this going about

Duncan McHale

Connor, thanks.

So I think questions. three

Let then, I'll of and terms EDPXXXX, answer time formulation. to the two capsule let the Mark question link we it the about situation, enteric me invest first the lines, Otezla in how answer

So with clinical in obviously is -- of of the and impact time initiation clinical dealing we're of terms lines, terms the what trial recruitment. in trial COVID-XX

taken we us recognizing the considered COVID-XX. of predict conservative can that to be we've So assumptions, impact what none of relatively actually

third year. dose-ranging context, otherwise and quarter, things, but psoriasis that that recruitment, obviously the dose-ranging starting that we're that COVID-XX we're hence, study assumed significant be by study We we in, the middle be in have assuming we've that have of some gave II impacts we'll type in to Phase guidance from will Phase in the this next the how factors the psoriasis So would II results guidance see there of starting quarter. that we and

And Obviously, sometime could be. situation impact, QX potentially or very us to for will of depending as as next QX. predict accurately difficult what results see it's on early year actual the the we in

to have continue be recruit of we're and to looking will would opposite to So perspective, an arguably we lines time And situation with COVID-XX, foreseeable treat in reflected terms in future. us guidance. reasonably Obviously, that COVID-XX we that's, quickly expect that's the XXXX assumption on again, at that the Connor. our how for that from that

to regards time with helpful that's hopefully, on line. question your So

is the Mark respect XXXX, a scientific of we three I'll to have, data, now from The and mentioned, the clinical about studies sets when effective separate a potential as clinical support very perspective. on separate as a point capsules three anti-inflammatory With core expect and in psoriasis well. as agent strongly talks he let psoriasis, which beyond this I we clinical enteric that embellish EDPXXXX and

EDPXXXX. about positive very feeling we're So

to you inflammatory it in As target disease. moderate been today Otezla, is need the to other patients with as that's point, And links always Connor. in view And diseases know, been big our mild actually unmet psoriasis. initial has always entry our most

we well-suited. is as a within is something compare much The think profile have at in with psoriasis and date And and to data EDPXXXX extremely mild data to have moderate overall least as EDPXXXX as suggests historical we Otezla disease, that tolerability safety on can attractive Otezla that efficacious with something has we the of more as profile. we much the

we affordable then that whole which medicines strategy large we develop central but our populations. guidance, of made given clear haven't to And across formal pricing part company are the patient it have for is

pricing versus have to So well. we would advantage as Otezla a expect

able based at as efficacious we're So we just to on data to the make recap, as comparative stage. least that this at are Otezla

to that a will pricing advantage much something have a we improved tolerability expect safety we and as well. have appears that and have We profile,

versus we're think very we So well Otezla. positioned

talk to capsules. me something EDPXXXX. to hand Let feeling over we're additional Mark Mark, may enteric well And about say how you about to about want

Mark Bodmer

I is Connor, about about will as little that, what there. we think impact, I to I clearly question, bit I'll that. And going the say then can do well. your on a more answer hope,

the you benefit in have of a with concentration is have had in sensitivity, we preclinical benefit one preclinical showed that bolus earlier asset number we mentioned the cyto data So if that the dose not to formulation due the any controlling dose And other been we which call. earlier the were mice, alternate factor formulations studies. including recall, of could factors, and I the for in which in the release, the release, the

proposing mice of for is the comments series that One the a it of didn't couple time out trial at in dose And formulation. man it with were saw we that. in effect factors into hit in man. the We where man. EDPXXXX. we We there that response we alternate we dose with So this because comparative went needed possible didn't the were a on turns wasn't that know didn't clinical have data the

Simba's replicated point, clinical to the other you essentially we us I a powerful tell tell and cohorts the questions humans, an formulation about moot given talked data mechanism is of the X because which, directly big in has data platform in immunologist, that is know this. small is to of need. the think I So is say, I access this we have functional started has it the but data. where I you immunopharmacology to drug, very since the going this, as doesn't it what immunologists alternate to in you as been And other lot about course, told our one does we the study actually, the I that a about what intestinal do

COVID-XX in able without to of a parallel, other the manufactured GMP skipping material been switch about actually why from the the been reason go same. to regulatory starting studies able manufacturing to the drug as the the into those continuously soon do substance And have are submissions as of doing it. we we available And is drug course, is Specifically, which the we we've formulations so make question none, actually, we to directly because one material studies. impact, beat, there has get both for we were for approval

it manufacturing, not the of it have drug chain supplies we for to been that the be and worth just as supply substance. there well. disrupted. despite out it continue We'll manufacture studies might has And pointing and Actually, future pandemic

Connor Meehan

Understood. Thanks response. for the

Operator

with go question ahead. next from our Chris And Please you. Cowen. Shibutani comes Thank

Chris Shibutani

are over help and some that we're the team. could how programs, a pandemic that's of that $XX you us based line R&D geographies clinical the different contemplating related the of potential that of in of Good possible? with kind just what then the million, your studies any the some the challenges again, studying you you. confronted We're for think there's historically, simply are Can to how morning question secondly, One, understand term? of ways. this I remind you've and upon thinking work context UK And Two have what support you different us in done questions. Thank the geographies. to seeing you about spend near time feel like, about of modifications, these framing context you runway runway is with cash the in the if

Simba Gill

Yes. Thanks, Chris.

you are So right.

We studies which UK are which have let in going we conducted the conducted studies and and our and about forward. clarify several in me the studies in conducted how think the that U.S. UK, of are

talked dermatitis including data So the carried about the historically, the includes atopic today that have those we discussed the Ib we and out formulation. out UK. been we've that interestingly with alternate that in And carried Phase psoriasis, importantly, studies and that in

the were on the recruit general, studies. completed we in studies pandemic, were those patients midst So and COVID-XX in of to able, to those still

patients Some complete is those did atopic but to drop allowed both recruited, patients described studies across the of the dermatitis the of we Ib earlier. to conclusion come and which the psoriasis Phase in and bulk out, study us

might to have in EDPXXXX The depending Canada, right that weighting closely to And the we Obviously, develops continue heavy out forward impact COVID-XX trial we're plan with go to have now, carrying the geographies. U.S. go it as and recruitment TNBC what CRO position that to Europe, will we're sites. in carried U.S. out out, with modify working continues in That forward, for how UK across as we we're make our a IIb forward. Chris. and on very clinical towards be U.S., the in different the dose-ranging sure been as as situation both studies be study historically be will Phase going and the and carried psoriasis well with the

The may we forward. be across as Europe of well modulate as number may projected we and multiple go in as so the U.S. UK, different relevant. geographies the sites which cuts well And

spread be But at dose-ranging it So across study announced probably Europe. going of is what as Phase is impact conservative, forward. the The to as because to the potential U.S., II we Chris, the don't to And just finally, and given, to the guidance risk. recruitment Rutgers. just clear, the we last we've exactly week, is UK there's continue underscore IIb Phase said, go being carried we some COVID-XX we then out be know that Continental Chris, but study as mentioned, I I expect is

So at site that's We cut have the all studies, at stages of the in in of the U.S. that discussions across U.S. disease different in continue types to looking geographies. we'll now. And single COVID-XX additional remain outside geographies and probably studies potentially a not-too-distant right study, announce around those do different multiple different we future. additional and COVID-XX the optimistic

with Then on cash runway. second the regards to question

key delay including importantly, XXXX. So a cash additional means before we the in study of on have projections, psoriasis, factored we that dose-ranging extension expense. reasons: the we of obviously study runway actually That's COVID-XX we II announced expect and One, of the deferment last in a Phase were current an couple dose-ranging EDPXXXX in QX Phase into where that of the IIb from from

pipeline. the platform forward continue EDPXXXX the a as was there's to And that's us benefit hard pandemic, focusing cut our we're as So move clinical soon in benefiting at from And from have of expenses as deferred on essentially We certain and we're oncology to without then fact now programs the and/or took in that. the setting. well. compromising and we company the key invest declared all across look with ability some a TNBC expenses benefiting our or the took, to COVID-XX

from Chris. that's from we are, overall, actually runway cash our were so where before, we where extended And

have into especially So getting QX we're that broad now we guidance XXXX. cash

Operator

And from our question BMO comes Matthew with Luchini next Capital.

Na Sun

saw the saw for give oncology keep what bit another Na, gave before, questions little data. a also the then on when happened from you psoriasis Simba, you you you we clinical that today for reduction did where you this see to on one on where trend Matthew. is similar to what And not And the then Ib me. confidence a going TNBC. the in just in going score, on what Based us? to PASI TNBC? on a Can if, saw you detailed more One, Two are make you color available the us in LSS trending, and the response? us? data Can for clarify and psoriasis completely any that

Simba Gill

Na. Thanks,

So on TNBC a of points. couple and the program, XXXX

a a KEYTRUDA combination collaboration So reminder, Merck's Merck. in study a just as you with Na, clinical that's with know,

So this we but that agreed any haven't with conference, clinical we're said clinical that of disclose will certainly, Merck a to we when until you data going I half additional at conference. which be, second not tell can't exactly have year.

I'm product. responses. a the data we And in gave we're that tell Na, with maintained, of would to number potential proportion are is seeing, those to confidence all TNBC are us having of And in able patients seeing that proceed, be now, small of responses you a terms terms clinical TNBC, if very clinical encouraging in the of

So obviously patients we see the of now we number TNBC, maintaining that clinical the rates. with of treated response number as those additional patients expand recruit goal is an being can we're to so

So year. in the provide at that's and of this will conferences scientific again, half right But color add clinical more second can now. data the I we

With in your regards to question on psoriasis. XXXX

be first Let all, clear. of very me,

that suggesting, we EDPXXXX is you same set immunopharmacology in So two the PASI which reported. separate data patients. severity enteric study, positive of as lesional positive formulation reported cohorts clinical data formulation a today and in Mark a showed, with of third What in scores were of psoriasis human

So the data have enteric immunology with clinical we're the the we and in response formulation. EDPXXXX with very confident

still not see clinical the did through a didn't And clinical we with the newer recapitulate reason did we why that alternate preclinically, What a of reported we've of see the details also there exactly response not the working newer results formulation because formulation, is, that now. we're was we the response. seen we formulation believe,

human of the there's translation most which, lot with in. third impact with response. today led the quantified a a mouse clinical confidence of of and the we're man, having detail, the in that But in in of a lack the data talked is to confirms from a have has way, something set important about clinical next to And be level different clear, the reported humans. But to about we enteric enteric we the formulation formulation point the in formulation, to continue possibilities. EDPXXXX Mark

So that. very confident we're being with

hopefully, question. So answers your that

Na Sun

Yeah. Wonderful question. thank Thanks for you. taking

Operator

Thank you. [Operator Instructions] from with is Our question Song Roger next Jefferies.

Jiale Song

morning Two you good Hey ones for oncology quick Thank taking for program. questions. team.

So they since you're therapy prototyping your view so curious, your the combination TNBC just then kind the we triple of, KEYTRUDA. around line -- your later of program, the obviously, of negative. which on thoughts approved landscape forward line other kind well, which And very potential the combination are the of competitive doing kind and is -- given amendments recently here, know regimen significant of a with moving therapy, in is of lots for Cabilly

Simba Gill

the morning. question. for Thanks Good

landscape. competitive you the summarized So I just think

are through, will to the by competitive we that that's have need combinations the we we with we something coming something believe data that So that potential have do to have with definition, and be newer the to date. that

to needs are you newer of approval. factored clear, And with now are response the been But combination to studied the new XX% you that in know, combinations the rates confirmed. as said, some it with as around level, approved. either or, at being be in have we recently Cabilly, So be

take competitive combination that have can newer be given that you that we as and those with a will in, something products. that factored it assume we we So

Jiale Song

That's great. great. That's

oncology Okay. And as quick then for another one well.

type future into think to succeed tumor have type I you on just not you you're XXXX, But you you TNBC at but negative, for -- kind in tumor would will triple expand clinical you If response. know they're lot. other other as done either the robust least in a some or and of focus

Simba Gill

and than of with we almost that's synergy that No. what inhibitors. will is there in the tumor then have wave with is certainly the -- And Na is against shown Roy, potential Yes. we'll results much checkpoint see XXXX positive that's expand, systemic sorry, because immunity KEYTRUDA if broader impacting TNBC shown, patients, If TNBC. next

highlight the and then the -- we expand question, we'll with that to to your but other will obviously, be to would efficacy expand. expand we Roy, need competitive, confirm If types. see combinations, the data, intention, we is to previous other that tumor So our highly, other

Operator

Dr. I'm in would showing I remarks. turn further Gill to for to call like his any Simba final not And the back questions queue. the

Simba Gill

to also, want on thank as just at said continued as Evelo of COVID-XX and keeping in things development. their who've interest a job everybody with impact my our thanks, pandemic forward Evelo, as moving clinical for partners I research So done marginal well in the during I remarkable remarks, and team prepared across our all our activities

we forward very you forward thank on much, as progress go you look So through everyone, and updating we to continued XXXX.

Operator

that, And today's with ladies participation. your and gentlemen, conclude we program. Thank for you

disconnect. now may You

Evelo Biosciences (EVLO) 13 May 202020 Q1 Earnings call transcript