EVLO - Earnings call transcript Q4 2018

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Operator

Good morning and welcome to the Evelo Fourth Quarter and Full and 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call for your questions. Please be advised that the 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. proceed. Please

Stefan Riley

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

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

Simba Gill

we're Good will Happy strategy, execution Stefan. review will Chief everybody, the Scientific review Mark and discovery review Medical which this year. underpins for Day. studies Officer we clinical Officer mechanism vision and over Valentine's morning, taking plans will have I Today, Chief that an monoclonal Thanks, our our clinical Duncan and to-date Bodmer, McHale, our many the our important of action microbials. forward made,

Jonathan Poole, question-and-answer. financial Finally, over Chief turn for before our the our review Officer call Financial will we

science, class across medicines. to dogmas and up role open Our convenient, medicines, and our for small of vision microbials intestine harnesses platform the monoclonal safe efficacious, multiple orally effective is potential play the in Immune and a a cells develop breaking systemic to new applicable central cost this business. broadly as governing our and immunology delivered in medicine

potential have major patient products global diseases impact populations. at the of Our and across chronic cancers disease to all stages

are We development pipeline, multiple clinical multiple disease different across with investigating pathologies monoclonal microbials advancing formulations. a broad

and continuing of our full breadth are opportunity. our aim We of pipeline the capturing platform with invest also to in the

microbials true emphasize monoclonal in University the Clinic plan through research well Chicago. and leaders and as the activities, XXXX. collaborations would of of our We understanding like I as Mayo against clinical and gut-body including have academia, advanced our the University, in to execution progress network Harvard with internal our

groups clinical nine clinical and to product Company trials diseases. multiple financing several of patient U.S. our a different on and regulatory enabling products the Our financial in three the ending oncology in Series We gained in C the initiated invest us strong and and with platform and four applications footing, approval addressing IPO Europe trials place candidates. in of advancement XXXX inflammatory

making in testament in I this These to and corporate manufacturing, research, launched. development, a to was clinical and [technical at this want like clinical progress property, remarkable programs legal, finance our of to our with have are development. achievements Evelo now and to team attracted Officer, trials. intellectual Evelo our done the difficulty] happen. affairs, acknowledge anticipated thank key regulatory our introduce we I'd less than readouts review clinical status, have the for We Chief inflammatory beginning Duncan Medical disease talent McHale,

Duncan McHale

Simba. advanced parallel. in busy candidates period has This we've Thanks, multiple clinical been as an indications clinically exceptionally three across

and a endpoint inflammatory Phase First, microbials of tolerability insight I'd the up [technical currently have trial studying doses first about of immunological a we're is trial EDPXXXX psoriasis. us which volunteers range EDPXXXX, test talk give included atopic trial placebo-controlled which into dermatitis It's in the EDPXXXX will we monoclonal primary the healthy of benefits clinical patients. to and in endpoints, of Xb its EDPXXXX. difficulty] like to critical and a candidates, and effects. And and the of potential The XX XX safety exploratory in

ThXX we're we validated dosing biology. We've with safety dermatitis of this cohort across expectations completed ThX, proceeded and as And and trial’s investigating volunteer modulates have healthy three of data Specifically, trial. to atopic following inflammation review EDPXXXX of committee, how review cohorts the the ThX, planned psoriasis. in the biomarkers clinically by of the

dose. range the We addition cohort times XX have dose and for means will metrics have equivalent of human models. both we scaling an our atopic add based on and full estimated of one-time additional a five the recently lower decided atopic of psoriasis mouse dermatitis patients to at from one-time’s that dermatitis patients The the cohort this

this expect quarter from We trial clinical second data the announce in the of year. to initial

later commercialization. healthy in stage you from study initiating EDPXXXX. we're includes our studying immuno-pharmacology an with As heard and volunteers ahead strategy Simba, Therefore, formulations multiple trials of

of in second first and the in this subject year it complete this in We dose the to the to first study expect half. half

EDPXXXX clinical monoclonal this inflammatory study, the second for to diseases, in Now, in expect half from portfolio dermatitis study EDPXXXX consistent atopic The of a similar and Phase we trial a the placebo-controlled we and with into initial Xb of our build strategy second advance include our to aim of multiple have the of treatment half the discuss We has like psoriasis. design advanced microbials trial portfolio psoriasis in asthma, I'd into EDPXXXX, year. to monoclonal microbials. our made in we've arthritis psoriatic data antitumor the progress first additional further inflammatory XXXX. trials disease. disease clinical rheumatoid and arthritis, additional to indications potential the with bowel indications inflammatory atopic And dermatitis, and our

immunological Now, of the therapy. challenges one in for the combination the mechanistic out is rationale field working

immunological NK that demonstrates and chemoattraction have relevance expression pathways. are modulating pleiotropic research These all in of CXCLX multiple environment, the MHC and preclinical non-responsive proinflammatory increased and Our current and see natural patients In or up the who cells antitumor treating activity. we XX, killer [ph] responsive immunotherapy. has micro tumor either Class to metaphase I EDPXXXX poorly cell mechanisms effects regulated cancer

EDPXXXX So, trials immunoresponsiveness. clinical in of open diversity Phase two in a tumor of label range broad is types the X covering

is and We Merck, relapsed of of this stable in effect EDPXXXX investigating triple-negative dosing commend and study combination carcinoma, clinical a colorectal a study XXXX. quarter with tumor basket in the therapy collaboration KEYTRUDA microsatellite types. in PD-X First breast cancer four

of investigator-sponsored looking dosed who on monotherapy for the in a In the collaboration checkpoint combination This then baseline with will monotherapy at combination patients EDPXXXX the Chicago, two and Now, relapsed of checkpoint both at trials, start study be the ongoing those the Metastatic of because [indiscernible] an is at naïve daily the EDPXXXX period inhibitor therapy second inhibitor also will environment. the study in they and trial, therapy. we'll the receive for by KEYTRUDA of EDPXXXX the look effects study the monotherapy and patients with effect daily be of at in inhibitor in Merck. with have of immune end therapy for Melanoma to on in University both is weeks EDPXXXX remainder checkpoint tumor study. taking

data the second and trial clinical half the We the in from of clinical the of first investigator-sponsored expect XXXX. from trial anticipate data half first XXXX in

over like Mark, now our Chief you update Officer So, Scientific I’d to on development. platform to hand the to

Mark Bodmer

Duncan. you, Thank

immune diseases. EDPXXXX recently non-replicating class need fills of immune the into to but the We've describe to by They intestine. microbes, some We to in inflammatory by our they govern required. have quite anything we The the of efficacy. new allowed demonstration monoclonal the microbials is the for manufacturing sense. first They work. fundamental an Coupled gap to engraftment the range platform. systemic small monoclonal immunity or of This structural intact, of our do what the surprising distinct impacts according are not cells to field. immune platform, outside in drug from cell window do microbials create like division extends product world this of It's new It on monoclonal can are of microbials they the the motifs in many and is be marvelous on insights monoclonal bulk candidate, This a from intestine. our has intestine additional and in intestine and the understanding the of signals into central immune how sense them. development the the non-replicating I'd of how and to with opening In tracking comes discovery microbial to monoclonal not need viable that effects. path of formal our system. the recognition for new we've and monoclonal and realization been colonization. also efficacy non-replicating tell cells of immune our main regulators a important indicates steps activity are that lining about immune found a us some products dependent and microbials generated small studies small non-replicating cells in effects detail on continue a the growth that work environment. our be with doing the body's a defined what This microbial these cells the coordinated I’ll of are up else core of not about discovery you inflammation produce contains of how small action discover microbials forms their these things and scientific our

our we natural, with but striking outside the effect The immune do of same our non-replicating gut, restoring or As a We understanding from intestine plain the picture consistent complex direction from live not in the reminder, associated coordinated the pathways of A to the pathways, reflecting nodes small of cellular, tumors is issues process health. immune the both targets. products. is And the of on monoclonal do. picture multiple observation and the modulation the disease this effects microbials mapped see validated sites body. in effects throughout therapeutic work clear to their of cytokine a with emerging cells lymph distribute

the not is these discovery basis of we will broadly many out body call that now gut of As oncology, control. comment, exciting to only believe address the for clinical needs phenomenon be areas. turn extensive of inflammation turn general range and range my This opportunities over in Jonathan. continuing of the an aspects to our final on also work, physiological to I'll and but therapeutic

Jonathan Poole

and the end Thanks, at at Mark. of cash, reported of of In $XXX.X end the compared QX today's of release, million $XX.X to the at cash investments million press million QX we as $XXX.X and end equivalents XXXX. XXXX

the will sufficient our these into and EDPXXXX our We second year potential our of EDPXXXX, $X.X current wrap the in call clinical the and includes million with total facility for million, million the period and XXXX. up trials platform clinical $XX.X capital XXXX. million R&D fourth in million Simba XXXX for our May and loss year for drivers to personnel expenses net professional quarter preclinical to were were required the the our XXXX. completion of for and period the fourth for was period to of G&A area. funds be the therapeutic quarter EDPXXXX loss and increased trials portfolio million continued to the infrastructure full-year of million growing expect XXXX, $XX.X million, to due as full company reflecting expenses Simba pipeline. from additional for clinical the $X for our XXXX. of loss expenditure same $XX.X in R&D XXXX of trials full same $XX.X and $XX disease expenses And during Cost needs were operating $XX.X the expanding increases ongoing supporting in $XX.X And increased fees, same These public quarter in in half operating G&A investments similar for indications the compared plan two for inflammatory to million me net the mentioned, And costs, expenses the XXXX initiation quarter for IPO million the XXXX. fourth the year compared net that the our to was organization in primarily $X.X compared expenses, Evelo’s in a period to for for $X.X hand XXXX. and were and $XX.X million back to With compared let in same that, finally, million compared XXXX, consulting and

Simba Gill

Thanks Jonathan.

built around have microbials well-placed for foundation the validate a of strong of we the as modality monoclonal believe to broadly disease We a are of and large for potential now world. Evelo all applicable potential to treat that patient populations stages the medicines with new

for creation. attracting special have. comment, With any attention. As leadership, happy to about companies very culture focused great final building you your may are people allows continuous very and remain that, much inspiring people in always that for a we we Operator? and culture, innovation, a on is you take and questions thank invention And and special

Operator

[Operator comes you. of Chris question First of Instructions] the line from Cowen. Thank Shibutani

Your line is open.

Unidentified Analyst

there is little about This bit Congratulations morning. more that last the immuno-pharmacology trials learn the question. curious for since hoping thoughts second additional Chris the taking guys. quarter, particular you're in is the for a for learn What indications XXXX. to I'm enable Shibutani all [ph] Hi, inflammatory behind study the half? volunteers the the that in for we thanks on will started in CJ this and progress better healthy to clinical that

Simba Gill

Duncan going Simba. answer kind is Thanks to your this comments. CJ, question. that for let I’m

Duncan McHale

the comments. for Thanks

include a test study, allows experimental these formulations. a would us results maybe say, patient provide we on populations XXXX new and may readout, such need dosing to developments And include immuno-pharmacology to formulations so and help developments of variety delivery. optimize the that of for so sort the to to it should and the monoclonal pediatrics and levels future rapid yes, accelerate as the studies future microbials, -- in around way So, would

Unidentified Analyst

types that provide new be there biomarker for of new like data, things would indications? And information that would

Duncan McHale

point, would for committing are they this terms the these data we internal program. not we're studies, At communicate to that the from get decision-making in of really

Unidentified Analyst

Sure.

Okay. Thanks.

us we for patients, seen to have for the included? you data you been will guys data it expect? and patient be the specific about data in confident of very What we’ll give all a seems. far see types Can XXXX upcoming what more biomarkers, also it number so terms You of should little haven't of volunteers, be readouts XXXX types will of color healthy data

Duncan McHale

highest we’re me completed So, through and firstly, we've let emphasize plan that healthy the very much enrolling EDPXXXX volunteers. on cohort in dose with

the So, based the proceeded as psoriasis both EDPXXXX into we review and atopic on dermatitis patients committee, the cohorts on of with planned data review by trial’s safety trial.

EDPXXXX. EDPXXXX volunteers, psoriasis clinical as second which each atopic on both We and of moderate line as quarter and guidance, of or the expect in for initial our data endpoints EDPXXXX EDPXXXX patients or study for the -- to and in this report year of XXXX and well of second is the studies the of this safety year in The EDPXXXX with mild primary are with are dermatitis. of tolerability healthy half

pharmacodynamic biomarker at of will are. be markers looking be the of multiple disease. an what measures include specific on will looking set And therapies which effects beyond. we're biomarkers, clinical exploratory the we'll measures not integrated those potential on guidance at giving We But of validated endpoints, and

Operator

Harrison question of our Morgan line Stanley. comes And from of next the Matthew

Your line is open.

Vikram Purohit

Thanks This on Vikram Matthew. question. for the taking for is

atopic the to a being antibodies, data from of last So, especially dermatitis. coming from of question couple lot small There's going molecules get we're our year, to compare over around is able been to this the in how data get previous going we're the going we're of years. There's compare sets. to AD lot this interest able to data about those -- and a XXXX year XXXX in data in from be been to

you think are And, share you would the will trial details that make help how So, there that comparison? design people comparison? framing could about that any

Simba Gill

Yes.

question, your point level high a make me Vikram. Let around directly,

on the used, of are advance is you treatment disease doing which Studies moderate populations, for behind So, of the in as know, distinct work most to one are inflammatory stages much antibodies very populations. monoclonal severe of microbials to the focused bulk and strategic importantly, of between antibody disease. disease the primarily very we're what all that's drivers

represent moderate significant Those take of variety for very antibodies a due populations So, antibodies. medical patients the the patient to needs. don't a unmet typically reasons, limitations of

wanted I just to So, clarify that.

briefly volunteers tolerability the patients, and signal Specifically, finding that in the study. just is of other now, point I commented the study, on healthy essentially then as aims and and safety main the a

for system a thesis microbials. by monoclonal key already the i.e., delivered is central immune immune small the we're the of potentially that's Company, be engaging the So, the which validate intestine signal, modulated in would cells looking thing can with systemic

So, historical data in that's we're really what to as opposed at comparative clinical looking studies. at looking

Operator

question [Operator BMO of Instructions] of line from Our the comes next Matthew Luchini Capital.

Your line is open

Matthew Luchini

be just you. into Thank you about about also study? same think your the be how products? the XXXX, and saw, might inflammatory clear, talk So, be dermatitis, then, healthy bit the patients for little second just comes And atopic will and a that about path should of to XXXX that up with out dose follow and you bit both to product the for expect your that And secondly, more Could data disease. the positioned questions, what active volunteers more quarter, in given to final following relative a moving prior in include on first, as you're of just why those inflammatory cohort we then, in addition question you that wanted one the little added would share thinking one-times the about I disease? existing

Simba Gill

Thanks, Matt.

first provide patients in well terms -- in readout will as volunteers. second yes the quarter yes, both we as So, healthy in question, of to your

yes. clear, very a that's So,

question Duncan, about Let to I'll over can me EDPXXXX. the additional with the next hand in he then and the XXXX cohort take expansion talk the

forward the multiple that now which forward So, Evelo activity generate is an treatment of drive profound. is, microbials discovery different we Mark indications. monoclonal data as strategy, in for multiple our of some which retained of even existing said, which What which And have antiinflammatory take when we’ll is the in opens the we products products take will unknown up expansion replicating diseases. that in shown clinic the different that the

inflammatory go profound a data drive EDPXXXX see other it at And tell in And clinical and go stage, is clinic the advance into can forward. way we'll you what this So, the will as microbes. we to what working drives, is the effects that represents. different we how biomarker we

So, just asthma, you colitis, detail, as more allergies, to the psoriatic from other in spondylitis, of ulcerative little to RA, illustrate know, everything colitis, Crohn's, beyond. and diseases, atopic breadth that Matt dermatitis, covers ankylosing a inflammatory food bit psoriasis arthritis,

So, differential so a each indications of we huge et of pathways there's which IL-X, by cetera. are cytokine breadth go different IL-XX, could et driven after, inflammatory cetera, IL-X,

inflammatories, on XXXX Xx indicated our current doing, plan always So, forward on So, talk the and the dose take on And with the exciting initiated how and in disease. So, about that's already and look more have been cohort the you now do and psoriasis color breadth we're we that? to with XXXX. XXXX. we product? of the just very with what at expansion breadth for we Xx of looking additional But, potentially -- both Duncan another XXXX now have strategy give we’re what already yes, multiple biology that's actually, dermatitis XXXX, XXXX. atopic to Matt XXXX given to Duncan, different want at

Duncan McHale

Yes.

to as study trial. the signal is -- is a that the has atopic of dermatitis that done clear, just looking nothing addition balances that sensitive we we so to had originally at detect anything to in with actually the higher get in but in and adding gives to signal in study and psoriasis. a to a searching do we a the enables psoriasis us searching By the higher a And Simba said, get dose safety dermatitis, -- signal were dermatitis this and both and What low atopic have the because more in that lower study signal, this psoriasis. dose dose is, atopic cohort, in been to be dose up both the

into the it’s improves think sensitivity actually the it we've sensitive as upfront more a that detect to So, we Simba it's overall said, the XXXX incorporated design, because design. And a design, signal. better

our So, a see optimizing ability signal it's just to there. purely

Operator

the the you. Q&A to Thank I'd the closing back conclude for does And like turn call session. this over to Simba remarks. Gill

Simba Gill

time much. like I’d thank just Thank attention. their for to So, very you everybody and

Operator

Thank you for us today. joining

now disconnect. You may

Evelo Biosciences (EVLO) 17 Feb 192018 Q4 Earnings call transcript