EVLO - Earnings call transcript Q1 2019

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Operator

Good morning, and welcome to the Evelo First Quarter 2019 Financial Results Conference Call. [Operator Instructions] Please be advised that this call is being recorded at the Company's request. At this time, I'd like to turn the call over to Stefan Riley of Evelo. Please proceed.

Stefan Riley

Thank you, operator. to call. quarter welcome operating financial and conference results morning, Evelo's XXXX first and Good we a morning, we This issued plan topics outlines to that the discuss today. press release that Investors available www.evelobio.com is release This under the tab. at Today, members our strategy, key recent on together and our the will of our Evelo's leadership Simba CEO, call financial with review progress team, Company's Gill, results.

if the forward-looking even of to disclaims any change. pleasure over of by Evelo statements today. Act impact including duty like that due statements and statements made of on of conference call forth call with to Exchange Evelo's the XX-K by do XX, forward-looking is December events differ made Before statements anticipated of relate Report the for forward-looking that historical our statements, any year Participants results clinical we Securities statements as subject any Company's materially XXXX, and now updates during should the to XXXX studies speak are the factors. the factors statements ended intended about to for and everyone to my meaning our forward-looking to be the provided fact, Private begin, objectives today and within to the other results provide protection operations forward-looking be and in Simba. safe It harbor Annual the cause to directed remind the the and monoclonal set Company's considered Form Actual microbials I could from pass views impact indicated matters risk not the are its would of Reform XXXX. timing those Evelo's to to only of to the Such clinical to the subsequent many Litigation milestones filings this of act. XXXX, Commission. reform Securities Any

Balkrishan Gill

Officer. our me With us Scientific of Chief Officer; Jonathan our thank into formulation and of Chief are morning, will and we clinic. Medical President introduce you highlight formulation new everyone, McHale, today. related Financial microbials Poole, call, Thanks, our for our Research and On Stefan. and new plans a Duncan to Mark and Good the Chief joining discoveries platform Development Bodmer, to Officer; the monoclonal today's

harness outline review We by will near-term begin I a financial recapping to which have also play to readouts newly our governing body. develop the is biological in intestine this thesis, in core anticipated cells our and specific clinical and central immune the therapeutic transmit to wanted act these that on the understood orally-delivered role intestine our therapeutic small evolved in results. biology activity candidates, the throughout We can which effects locally body. throughout to small cells

class are science, new Our at of stages modality breaking Monoclonal called immunomodulatory are business. the of which chronic effective, first of novel to microbials microbials potential multiple monoclonal medicine Monoclonal a have and affordable, the be microbials. safe potential and impact all cancers have and to disease. major dogmas oral across medicines, medicine conditions

our platform in pipeline. Our strategy and investment portfolio with clinical combines diversified continued a

in indeed our On driver key research period release, is in and efficacy of discoveries ongoing announced have deliver research our side, address this, monoclonal of the the improved right the discoveries need To small of the agent to focused We the on time. for right important to right These engagement the intestine amount formulations. that the most platform from place developing to microbials, for efforts link target we is view today's right new press as we for medicines. team. it

for a the potency monoclonal to vivo preclinical key novel our significant that we XX-fold improves reasons. recently have This microbials by platform a formulation is models. in that We are three delighted to our the in advance up of across report discovered

First, pharmacology. it is small formulation-dependent This of of defined dose to cells the microbials, of immunomodulators engagement new and our has intestine. in monoclonal believe immune dose-dependent the we reinforces linked magnitude the class activity which of oral

significant of optimize towards presentation our the allows later-stage and trials and to in flexibility it therapies potency commercialization. Second,

the Third, to in it further our property. strengthens intellectual of the our value position and Mark, clear as leader our over field you.

Mark Bodmer

Simba. for you, microbials. of basic the discovery you medicine. an I Thank of of three effective to tell monoclonal the like more requirements are formulation potency impact There of about the

The first relevant biology. is

evidence. can preclinical is by on to supported that extensive intestine cells idea immune our As the effects which Simba said, orally drive throughout biologics small is in act our body, central administered the

The our tissue, in people a with of action range and the one second is translating from the small conditions lumen line profile and stomach the intestine. with and medicines. part biologic major effective the safety in the intestine, our capsule, in which but is systemic that expectations. of which our formulation opportunities, formulation some effective challenges, of clinical and doses effects medicines, engagement the in in are third in current XXX the biology small protects from cause delivery and interesting and microbials The are particular tolerability tolerability. is have the that of taken releases is present a of correct when the And oral formulation Over dose adequate for target required safety development candidates dose and into monoclonal

as to also We've seen original for we our by up a boost discovered by reduce these higher models. means to formulation, pharmacological that a dose efficacy potency have new can to we new of is effects. the maximum. in both vivo compared efficacy finding. greater It with doses, we XX% this extraordinary At a formulation preclinical of said, can an level which as XX-fold much in enhances And Simba given As preclinical formulation.

form pharmacological the our and This location discovery by with the of of modification it formulations the of I've months. a that use of are dose. the intestine. act drug optimize microbials, to monoclonal working expected pharmacology like this introduce this potency Last probability effect formulation I'd clinical right patients microbials formulation. make can have There's entirely the This the same can the It's formulations out a be right turns into formulation. striking it over we these manufactured In simple moment, at delivery be affected future drug for into including profoundly effectively. And and active the quickly into So and pharmaceutics to with coming To the mentioned plan trials. will Duncan the about give be trials. I a to non-replicating the that state we in to since convenient happen substance, translating right of effective patients can to our preclinical substance. update finish, the effective drug no small And how we're about clinical new is in that and cost comment the monoclonal and formulation. medicines brutal to enhances effects into the developed incorporate and research talked and formulation today, quarter, current

yet and the reached haven't continue We technologies. engage oral in we to the future. which in limits of new small of potency intestine medicines, Duncan? We'll invest cells the in these news of give

Duncan McHale

everyone. Thanks, Mark. Good morning,

doses multiple clinical strategy execute into We diseases. product and candidates advancing our on continue multiple of to

profile first healthy that volunteer we've Phase now over announced the EDPXXXX XXX in doses with remain expectations. three dosing in As two of tolerability our line Xb dosed subjects safety completed of monoclonal our mark today and cohorts we've monoclonal of microbials multiple And the microbials. The trial. mentioned, with we

of patients review to have data safety the of psoriasis. trial Following by planned we proceeded, atopic dermatitis the committee, or the as cohorts with

in are studies in patients with So programs, dermatitis I'll Phase Xb atopic EDPXXXX now clinical which briefly review both the or psoriasis. EDPXXXX and mild-to-moderate

endpoints, is trials of Now will of the us tolerability reminder, systemic these insights exploratory EDPXXXX to clinical safety a endpoints, immune product as the also endpoint give into first we're potential EDPXXXX. in the the measuring And the on of their and candidates effects primary safety and benefits these addition which and system.

cohorts clinical initial cohorts report two XXXX. quarter the from dose-ascending to psoriasis data in with and early volunteer expect of formulation we third EDPXXXX, initial with three patients dosed capsule of the healthy For

that data we dermatitis in the doses this a order You added two of atopic in in atopic across with capsule lower-dose to will cohort year obtain dermatitis recall earlier formulation. patients with

atopic formulation addition of and the on this team, in the of additional clinical quarter team of in in data this with study third Mark's development the from or With psoriasis us to fourth this dermatitis of data XXXX, from two from for expect second half to the quarter of Based formulation of cohorts year. initial we rapid initial clinical expect now this quarter biomanufacturing we new report potential of XXXX the during the the cohort, first patients the and the XXXX. dermatitis This gives atopic respectively. data dose new

introduction the second EDPXXXX XXXX. currently to similar of For design during EDPXXXX, formulation modifying we're its new this study and half and the design accommodate study the to the of has the endpoints

data early clinical So this we initial dosed in with XXXX. from patients trial, the now including new expect formulation

announced studying As are in we efficiently volunteers, February, doses immuno-pharmacology an in and different clinical study EDPXXXX formulations. test designed healthy to we in

also model. monoclonal clinical and into immuno-pharmacology to We expect EDPXXXX future this introduce microbials anti-inflammatory

in optimally of these in advance initial patients the us will diseases. we microbials the position to the from together, significantly effects wealth inflammatory believe trials and inflammatory monoclonal the months Taken in clinical into data expected studies next-phase advance of our coming of multiple understanding

EDPXXXX are stable This X/X responsive effective which So one or patients of to the two triple-negative tumor are inhibitors. combination is enrolling. in following. diversity clinical tumor the types, PD-X a oncology; in of cancer KEYTRUDA basket Microsatellite Merck, Phase to relapsed EDPXXXX in colorectal the is carcinoma, currently clinical types. investigating collaboration non-responsive we and with a investigated trials study being moving and therapy with of breast In checkpoint poorly either

daily then taken EDPXXXX the for to reminder, baseline tumor-immune with of end the period monotherapy start of the at the the of patients inhibitor the therapy on monotherapy the for dosed at As and of weeks at study. trial EDPXXXX be measure microenvironment. Biopsies daily will checkpoint monotherapy the a with and two EDPXXXX the remainder combination be effect receive in will

trial data We continue XXXX. in initial this first of clinical the half expect to from

a therapy. who two Chicago, also is naive conducted combination both and This who've in University checkpoint oncology KEYTRUDA Merck. are inhibitor study in The patients metastatic collaboration is and relapsed inhibitor second, ongoing the of study at study EDPXXXX being checkpoint Phase the looking investigator-sponsored those of on with melanoma, effects by in therapy

the at the is when As period beginning there are monotherapy in of monotherapy biopsies a are with Evelo-sponsored EDPXXXX paired patients tumor period, dosing our dosed and the with collected. study,

XXXX. clinical our anticipate of to initial to data to Jonathan from to through like in the second you trial financials. continue this half I would take now We over hand

Jonathan Poole

Thanks, of million $XXX.X to the at cash, cash investments the today's press In Duncan. of end $XXX.X XXXX we the and million end XXXX. compared of at first equivalents release, reported quarter of

the into requirements will expect that funds our operating be and expenditure half these of for second XXXX. We sufficient capital

our mentioned, additional the of Simba the EDPXXXX, clinical plans As include clinical trials in initiation ongoing two and therapeutic and of clinical indications on data our for from based trials EDPXXXX area. completion trials, current operating disease inflammatory EDPXXXX our in ongoing potential

development period intestine, also now and immune the new XXXX, oral We trials. increased million monoclonal of medicines, which remains the to same research quarter four expenses clinical strategy. in expanding $XX.X reflecting in core groups. million and our cells small Continued first nine clinical R&D different formulations microbials for have trials engage from patient in the three $X.X separate portfolio of our forms in of to

$X.X required million period have net million for were platform $XX.X over same XXXX clinical hand organization a pipeline. million with first loss loss to the also to to our growing And public in of net quarter that, the to We me first $XX.X G&A our were let to quarter XXXX. for investment back R&D IPO These finally, Evelo's XXXX. expenses May infrastructure and following increases due cost the period for support XXXX. same million company was $X.X Simba. and of for in the continued in compared compared in And

Balkrishan Gill

developing would monoclonal which announcement the important the to developing Thanks, throughout the forward we pharmacology oral and formulation behind of act microbials, a optimizing new of the microbials. one of the microbials monoclonal immunomodulators. significant of immunomodulators, in Jonathan. in To strongly cells positions I transmit intestine with like of recap locally monoclonal modality broadly-applicable today to as towards advance effects confidence This our our class to a emphasize us Evelo, oral science leap are therapeutic small new body. potential vision

keeping wealth and We have. you happy a the data of progress. take be coming We'd over important months our forward of to to expect questions clinical now look you any may apprised

Operator

Instructions] [Operator Morgan comes from Harrison Our question Matthew with Stanley. first

Connor Meehan

for Thank Connor questions. Matthew Harrison. Hi, everyone. This is on taking for Meehan my

added Or having additional we the for in on purely were these the cohorts. patients therapeutic window? were wondering, just interpret it have Is we So how wide we additional dose? to need wondering to based push because you both need programs, you should

Balkrishan Gill

by, discovery powerfully with as to But anything potency said, remain we track It's a a driving clinical driven before. very on that's have the Mark formulation positive development very than that XX-fold new we've up studies. we more existing the seen much

So is positive development the driver.

Connor Meehan

just a noticed you and plan the the just data characterize how follow-up; kind compare that agents? data. you against wondering And psoriasis that also We might these have what Awesome. AD we studies shorter so duration, on are have quick could of impact currently-approved to

Balkrishan Gill

Yes.

biopsies and patients. biomarkers. obviously, an So the finding And the signal of volunteers signal based looking set purpose is through confirming integrated in beyond, safety that ongoing of finding main is in and studies at tolerability healthy upon

for. looking we're what is that So

existing to in And so valid not with for context. that comparison it's the therapies look

-- The mild fact is we're moderate strategy need. our is actually that, we're to on that of other is, other thing area patient focused core focused is the significant and point unmet an to on the

So existing mild antibodies, used to that in example, generally are moderate population. not disease for

with that. So make we can't comparisons

Operator

you. Thank

Shibutani comes with question Chris from next Our Cowen.

Unidentified Analyst

you a this is question. you've Good wondering a provide of the Chris. for CJ provide change in taking affected, maybe, potency is on been This color different small a [ph] the at little delivery for little high there. highlighting, specifically I to a was being slightly formulation, due to, extra you level, if as about you intestine? if morning. how, portion Thank color wondering, Just change bit the in this more could is can

Balkrishan Gill

CJ, Simba, on not details very We're this deliberately morning. is good formulation. giving any the

intellectual competitive said, for it's very again, perspective, and to a the keep it's As Mark confidential. important discovery, pretty from remarkable and information property us

very leap during giving quite but a any the it's said groundbreaking deliberately So as not details, we really forward, we're call.

will about I that to have if data able clinical things accumulate one forward? formulation older data Medical Duncan, into could safety new from bridge the Okay. for follow-up, our you just you this integrate be requirements then the the -- or And trials, What be you that phased might Officer, how as that to need like question. going formulation? moving new will answer I'll Chief there are let to the be

Duncan McHale

Obviously, it's first study. the

can first there's database, the later study not develop it's with trying we're fact, the the in So compare the cohorts a bridge from optimum safety that but to and to earlier across bridge need to database the we we'll But formulation. through no large studies cohorts. safety the ongoing

Unidentified Analyst

Okay. Thank you.

Operator

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

Matthew Luchini

Good morning, for for questions. the thanks taking couple me. A

what models back recognizing that introducing terms data? upcoming with data relative bit other? in have guidepost you trying sort terms similar you at that probability new data be of sets, then formulation or going that gives later those dermatitis formulation, healthy bit presented keep can the -- how the Thanks. you in evaluated cohorts wanted year, of things patients. the confidential -- you're a should in into are about formulation all translating can the for if type thinking this around confidential, talk be then staggering, these the used a you those initial in relative somewhat or or maybe maybe first, different a we little the to follow-up, the were the preclinically how will you're to just So about get be Just coming the coming and in the you've to -- of each that about that data the new to communicated of seen you've higher formulation? And to does in, what quite hear more And change trying XXXX atopic to from little confidence psoriasis rationale more volunteer in given to of new

Balkrishan Gill

Thanks, Matt.

So answer perspective. question a formulation I'm first Mark at we've to comparative the models going from looked let which about and

Mark Bodmer

Matt. Thanks,

constant. making Actually, models we from a formulation could get held part to was other. we've critical the a one comparison So the valid that sure of

to You in mouse the used doses response may dose model recall man. that inflammation estimate the in we

at been the we've in new So looking dose with formulation. response the shifts

of that. are target the we through engagement so And potency increasing

in we mouse formulation. is that So on same this effect dependent doses difference get model, the administered, for is which the but the a

Balkrishan Gill

I timing. me And helpful, clinical the hope what on if me know, looking let question the And you give Matt. address obviously. were that let think then was you I've answer understood but an let me not I question, that's for, and

we for volunteers guidance year. simply time. if quarter with driven we this the third recruitment And at in Xx the and Xx readout early XXXX, in So, of from have cohorts essentially look patient in psoriasis that's first healthy

be frame. will read in to quarter, Also in out that and dermatitis time Xx. ready we'll that out Xx third read So in atopic the

that's Xx And the the the able very at prepared dose Xx So versus move the as formulations with existing then current forward we levels. and with to in formulation, anticipation. new rapidly that remarks, we're described

Duncan's a and job, that process ready principled and development to forward. manufacturing team's done and So great move

are giving in XXXX, immediately for atopic and read the we quarter year this formulation. in respectively. first XXXX So fourth out dermatitis integrating psoriasis guidance then being quarter we're and XXXX, the And new the of

expect we your formulations across cohorts in Does all that to with early XXXX. question, read answer doses And so and Matt? out all

Matthew Luchini

me sort of. I try again. Well, guess, let -- the maybe,

bit together. could thereafter, data how, data? initial interpretability, all decision So data, shortly we're does of given something come about in change dermatitis first the the you little talking the clear? that tell potent you potentially will, if expecting -- we've to much more that me about the the the introduction just atopic right see kind heels? data these to given if volunteer a are on that's -- was from talk its stagger what this follow-on then question psoriasis if guess, little And about healthy I a that more Is at you the you'll from bit that formulation of new all, have been

Balkrishan Gill

Yes.

a it's bit little think I clear.

to et So timing readouts, clear be terms cetera. just of the of the in

of which the extra cohort described. dermatitis we last On timing added things, the atopic on because side call, is, the we I announced as the earnings

the in the going on driven I to essentially. question date, your data, interpret should how think by be you of terms it's

able that great see good see, we if readout, new data in So the we first should these into went first because we that's be we obviously studies, very positive initial with expectation the whatever formulation, improve And a signal the is but on signal there's news. formulations to striking. the

So if news. answer And improve that's there's very good Does seeing event formulation. got assume positive the great with on that we that we've see would positive at can data, the good that. one possibility question, In see that shot we don't follow-on a your it a data, we Matt?

Matthew Luchini

helpful. Thank that's Yes, you.

Operator

[Operator Rogers with from next comes Instructions] Jefferies. Our question Song

Rogers Song

thanking for and Good taking morning my question. to you

XXXX So, question my cohorts. is healthy around volunteer

can of in you communicate if So just the the have biomarker the obviously, the will results any observed. signal PD all, so curious sometime at safety, beyond completed additional cohort, future? any you've already you. How, you that share kind information you Thank

Balkrishan Gill

Thanks for your question.

other And well the terms tolerability as once set to in no fact integrated very safety, completed biomarkers. additional XXXX, we've that cohorts, full data safety to on in patients cohort. as the So of future said, the through data we've as announcements, Duncan present report of the we'll than, gone similar

at early by all well, variety in cases, looking of in XXXX. scores a XXXX expected case clinical and the are, that's of We also as

Rogers Song

Got it, thank you.

one So just more maybe question.

updates XXXX there? so study immuno-pharmacological from results, if So and will -- you already you communicate regarding study so how XXXX, obviously And any is this all? ongoing, us for at the

Balkrishan Gill

Yes.

variety studies back little of to and doses, the us to forms test immuno-pharmacology formulations. different step to just the of purpose bit, allow is So a the

something experimental that is it's And see whether guidance, that set To that we'll formal announce when driven those to the so, important, that's of see an we that we'll But by going basically. we ongoing because it if not carry or out. be studies. there's we matters degree, studies data no through something find and

Operator

Thank you.

Taylor question next Our with Chardan. comes from Feehley

Taylor Feehley

positive. the based sounds sounds questions have asked, that formulation I could it's that congratulations seen huge the progress. The is on like change advance. thus there on that other some wondering far a formulation the it's though, you've which change like of concern in tolerability quite been already any And was the

Balkrishan Gill

Taylor, and your new thanks for excited about are very comment we the formulation.

no. the think I is, short answer

regards to with there no to have We issue little? tolerability. know I you Mark, believe if that expand want any is don't reason a to

Mark Bodmer

and we're we so view, range think Yes, small same just slightly overall doses setting point see forward. we're improving, a the from going at within part engagement for it's the we've and changes don't the increase the of is of that. but substance profile drug quite that delivery as in major kinetics. looked tolerability, safety of without since to doing But the It a gut. we expecting a the target risk exposure, not What intestine, achieving same

Taylor Feehley

more follow-up one clarify. And to then just quick

the monoclonal you should direct the the As said, so of drug still we substance intestinal interaction the hasn't about immune correct? cells, thinking small microbial be changed, with

Mark Bodmer

Correct.

Balkrishan Gill

Correct.

Taylor Feehley

taking the so Thanks fantastic. for much questions. Okay,

Mark Bodmer

Thanks very much.

Operator

and as in Ladies conference as question-and-answer conclude program. you does for thank call. the session today's today's gentlemen, This well participating

disconnect, You a may day. and all have wonderful

Evelo Biosciences (EVLO) 5 May 192019 Q1 Earnings call transcript