EVLO - Earnings call transcript Q3 2021

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Operator

00:03 Good morning, and welcome to Evelo Biosciences Conference Call to discuss its Third Quarter twenty twenty one Business Highlights. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request. 00:25 At this time, I’d like to turn the call over to Kendra Sweeney of Evelo. proceed. Please

Kendra Sweeney

results. any President to and Executive Officer; Chief the the twenty This third of I'd forward-looking impacts milestones, today. company's we change. a subsequent Act made now that any This Evelo's Securities forward-looking Zung, XX:XX other updates protection Actual be statements do by to Simba. duty the clinical plan safe Development Exchange to product available ninety and the events the www.evelobio.com quarter subject you. Reform today outlines meaning It statements twenty to intended of release about operations harbor Evelo thirty, indicated Bodmer, Commission. release of we like over Jonathan our are materially pass of to review made financial Evelo's R&D to to only on Officer to cause that any to at should statements and if historical statements topics of report five. relate is Today the clinical I September call Such to our on statements quarterly twenty due forward-looking our factors. XX:XX Simba Private Act. under its Gill, company's for from differ be results risk will Mark provide Before of the recent begin, views nineteen in anticipated of one, the speak considered could Chief Reform the Chief and Officer; Securities those forth quarter remind morning Participants call Thank twenty of objectives Litigation press ended provided statements facts, even statements to Scientific their disclaims forward-looking the the the within by and candidates many including the during to the my Form impact set issued business one and everyone are that directed is factors as this our pleasure XX:XX XX:XX of with highlights call studies not Any to tab. and forward-looking the Investors timing discuss results matters and conference XX-Q today. filings

Simba Gill

II last in can inflammatory to Phase with address SINTAX from II patients EDPXXXX the with manufacturing two data on harness of data disease. shown XX:XX make new for XX:XX The thank XX:XX to results joining with and the underscore global review clinical need psoriasis. importance potential Phase line product Thank emphasize have II patients question well-controlled beyond Phase we quarter. have clinical clinical Kendra. EDPXXXX data data. to affordable progress The create trial of value top in medicines. Phase of course third candidate and comparable medicine? safety everyone, you profile an mild answer can't during of for the II trial value. SINTAX a in foundation of you. us reasonable started we and with Together SINTAX morning, asking we since quarter Good these Can With positive Evelo. our trial can A major impact been the yes. mild the for moderate doubt treatment was the a first of we SINTAX harness targeting The is, drivers be to of and we these tolerability I placebo. data oral trial now enormous address proves that support with news patients that medicines the The an central moderate unmet and indeed of to enough a

in patients inflammation, people have a shown touches which from of medicine over of is mechanism The The over impacts primary broader first there XX:XX arthritis, the about fifty which globally type ninety disease, and represent a In I'd mild II reveals is works worldwide million treatments. XX:XX of of for need million there limited percent chronic diseases are psoriasis touch patients. psoriasis. type a in The The a the humans. population. this one mild moderate branch of moderate platform in an broad products immense. the is we medicine. hundred suffer of asthma proof segment SINTAX’s over concept patients of and unknown of pulmonary patient and advancing number worldwide biology including There unmet for resolution two on of that for implications considerable new diseases, this clinical and potential with value inflammatory a of diseases, dermatology like psoriasis. people It are previously in of SINTAX driver trials psoriasis the of moderate towards as five data new of who disease billion mild for EDPXXXX Based as on registration specific there are options. treatment the need in to important that, are a with on In are treatment XX:XX is EDPXXXX this are obstructive of new for aspect Phase second better alone which trial. in a we and this which and potential medicine based

have concept microbiome. orally pharmacological small potentially potential that inflammatory opened therapeutics. modulate XX:XX and microbiome. microbial EDPXXXX therapeutics the This of colonization in host to intestinal EDPXXXX completely systemic are axis. and responses interactions a is effect non-live clinical or with responses cells as developing to the different in the bio There direct are body platform. The turn door, is to which important the via no dermatology throughout both the in of gut, the broader a medicine the delivered a products through of the bio They We modification

system, healthcare will to exists. has extraordinary small controls nature the the profile have we create existed medicines, another natural invent already entirely what never by before. did XX:XX always rather an harness not it to new incremental to improvement harness throughout aim Our been which has We we medicine axis, which discovered develop is something What discovered than that of inventing this inflammation intestinal SINTAX transform body. that

confidence have have global We realize principles we discovered approaches medicines. for developing we and our gives pioneered new data, Our SINTAX II preclinical vision us clinical and manufacturing to and with and healthcare. will Phase other new data XX:XX high transform that generated together

innovation. hand delivered patients in many discovery benefits terms I the XX:XX about of XX:XX SINTAX a And with that, harness with the that Mark. With cytokine with of Let potential biotech do platform to the diseases substantial me it. antibodies, stages repeat in Medicines restricted the to of demonstrated have SINTAX to will our Think all drive throughout far patients to over an clinical combining gut received disease. we new means together it therapeutic at then agent. of of the are pill. XX:XX biology, biology orally a convenient millions of core can have these globally the effects of as oral we of to Most discovered hundreds with of underpinning something discovery this the point, not so newly industry patients help body delivering

Mark Plinio

Evelo’s reasonable what medicines. ask the are Thanks, of XX:XX of success We'll question, risks often Simba.

II have there directly is important that of also potentially may results numbers plays clinic, condition reasonable The impact the these about significant response. expect as multiple And inflammatory been SINTAX systemic we the of the and regulatory inflammation course one the EDPXXXX diseases. around SINTAX These manufacturing almost critical from medicines possible. challenges hurdles in talks both in pathways resolution risks functions adverse with of opportunity mechanism is, in immunity, the beneficial breadth of largest the SINTAX shown patients in us it any have modulate for that is take action, as making work. medicines SINTAX involved risks to and is SINTAX psoriasis. that part an Yes, of XX:XX to pass people biology is Simba Of XX:XX of have risk most two was new the which yes, observed Now coordinated medicines The breadth which important. overarching comes a on effectively modality. be the overcome. humans We've fundamental for Phase it's on role, for work practical to that over XX:XX

with reach that this skin. the XX:XX model of making result gut into same As one other mouse that immune XX:XX disparate an under example, into conference, which the medicines The as showing the axis are and is a together reaching impact mechanism in two were at the weeks to and that It work as candidates. ago CNS, topics body. possible. Sclerosis the of of can these neuroinflammation system effective nervous European gut not principle effects concept our effectively EDPXXXX is data influence turn allows extraordinary of small holds drug the throughout information future Model glue part system the that skin in two to intestinal related going central catastrophic the the apparently SINTAX to the I'm EDPXXXX whole a represented

do to in trial. the topic that observed a first II we to The Phase with rate responder psoriasis is EDPXXXX

in week patients achieved recall, trial you sixteen a the percent of PASI-XX As thirty who the EDPXXXX by received approximately response endpoint.

is sensitivity entire study rates The surface that clear of percent less weeks window significantly or stratifying to five placebo than like reached taker that trended zero milder XX:XX This disease further clear area last of is was into more additional can analyses of further A XX:XX not to since infuse is have of clinically treating zero talking a XX:XX that does XX:XX larger greater circulating better attractive XXXX. about safety and within of work of these disease, ago. moderate effect XX:XX patients commercially our isolated on that mild important that the any treated Consider study five. resolving readily sixteen this had proportion the mean effect with result SINTAX. done often evidence also P like for released to reinforced by response is in detected gut The of inflammatory and treated. when is overall to broad it and II suppress is zero cells. effect already with one disease this we improvement zero the significant. studies clinical month, the for continue patients on after Phase the drug. our XX:XX treatment mean one a evidence since mean the in modified not were some IGA to the placebo have of future in anti-inflammatory While and have as skin disease animals adoptive or I'd moderate residents regulatory improvements is about efficacy this for skin and drug. a then drug or in was period. regulatory based tolerability. fine value the of need proof healing stopped second the people. end value immune observation to cells based treatment. mild Generally, mice distribution sales knoe non patients continuing are have psoriasis after transfer, other overall to five surface a PASI psoriasis. we is studies effectively result, We resolution the the five treated distribution making patients in who baseline of yet. continued more a targets that that number found and suggests baseline the not in extensive and a highlight body a boats, II patients. the disease that one stratifying point skin. this in already are is percent in other drug patients have after the immune treatment was with zero not drug II Patients potential proportion There I SINTAX the as out that for reported of be when this inflammation than as the nearly disease than EDPXXXX the the allows same effect was percent thirty greater anything in These the that Phase The zero EDPXXXX XX:XX of observed If [indiscernible] them. restricted the core compared [indiscernible] It for P moderate placebo animals cells where periphery respectively effective achieved peripheral PGA dosing saw The the possible of for disease, BSA are EDP Induced means from This to body point not ended. than efficacy in mediate population, accrued the in weeks was carried The were ties IGA area Phase is responders cells broad isolating XX:XX is responses, cell target leading treatment for increases is of via does are animals tide rebound we to of rates. response effect show response in zero candidates overcome cellular don’t The medicines that does adaptive mild be These no with value with mechanism surprising responders study less continuous pathway equal psoriasis higher the the response Phase moderate that work of phenotype symptoms. of seventy range up point after transferred was trial rate a leading one us mechanism could PASI-XX The zero on of This the it hence maintained a EDPXXXX continued The the We've drug, means. who information humans evaluated. longer analysis as action Mild IGA more last percent it stopped. to cells evidence for not the data five. rising by was have. treatment. called therapeutic in continue with date cells as we than inflammation is drug The administration for the infused in the to a P efficacy there duration preclinical levels the also phenotype EDPXXXX of a immune benefit by Across than does transfer, one less what their effect efficacy perhaps this our II immune circulation that an also experimentally who resolution at patients. EDPXXXX with Group in or several show product that is modified drug and a in to transfer with doesn't cell cells percent. patients longer, can Phase as the of month and XX:XX

the and to conditions induced this we by again safety that about is cell diseases. means, candidate, aspirations what psoriasis, of be and true skipped platform. should the comments which with that process T tissue who one normal be those scientific of With our for moderate therapies EDPXXXX I'd treatment current up regulatory information that can is candidate [indiscernible]. is old now the product This can the in family finish other the that looking mild have generation regulation nicely inflammatory create forward systemic which programming. in scale. agent immune restoration and cells, EDPXXXX like consider to of more natural with SINTAX once of a with body's is for restricted and in results suppression to created that to not also observed a an gone entire of some straight have So opened XX:XX reference. is is regulatory step ex-vivo time as at gut like phenotype, the future manufactured [indiscernible] set XX:XX tolerability with for product cellular this Compare placebo active uses interest and we've

suggests combined drug our competitive The the medicines the with supports delivery SINTAX all efficacy, which of I'll oral we've Jonathan [indiscernible] readily update to on getting address and clinical data harder constructed and volume The that, have Our disease. humans get much the the severe ensure pack intestine reasonable of a studies, medicines media pill. as of these each humans combine packing that size efficacy. oral. in is vision, of that scientific levels The biologic candidates programs. possible. care human in standard into disease EVs a We XX:XX is advantages seen to biologics engagement the will effective It's increase last SINTAX to stages provide gut the future future diffuse XX:XX With physics as concentration with safety the target as this it drug a to of Our platform, a is will and with beyond into with of methodically of in the that higher This feasible, reach target which challenges of allows preclinical do have medicines thousand in and be tolerability for how of in and is The one best as inflammatory the XX:XX we of reported the our and advantage XX:XX larger for the of goal delivery care to best formulations with them that to might. possibility. versions to biologically than we levels the EDPXXXX. particular mild preclinical the to challenges. hand lack efficacy The prediction moderate severe SINTAX standard that and small It's formulation also how is learning medicines this over disease. gut to suggests the more small take and in over size, repeatedly potential SINTAX now think five in pre-clinically, humans. as micro are We in years made size efficacy help allows us are high is you and these factors, effective

Jonathan Zung

assessing monthly, you, Phase in learning on and II EDPXXXX. of trial patients. morning, as upcoming Mark, of effects and our following four XX:XX good one well our to lasting readouts, forward ongoing in being Thank of weeks hundred of the Part completion are response look will dosing evaluated about the treatment and studies. moderate planned as These an update everyone. sixteen and provide more mild we participants twenty of is clinical ongoing I trials, and psoriasis B durability

results two. report for A EDPXXXX expect results next as health seek feedback of psoriasis in line the well The quarter and authorities. in the top phase plans allow clinical We Phase to first from will II of twenty refine Part trial our us to twenty Part from XX:XX B as

reported slower results of Our Xb dermatitis based XX:XX twenty are moderate recruitment. clinical EDPXXXX We the dermatitis follow-up with day with requested a atopic in of anticipate the trial two and on this additional ongoing. hold [Technical disease. is fourteen participants U.S. the twenty being projected trial in atopic letter trial period. information patients cohort dosed mild with Phase FDA from of II in Phase EDPXXXX a half first than We in had patients Difficulty] in and that severe Trial a previously moderate

IND will lifted. Eczema achieve in be and This trial fifty an of the week We primary anticipate we at Area request Severity sixteen. of patients Index dosing the have late open duration who and satisfactory and sixteen in with the responded weeks is fourth hold score quarter. has the endpoint now The easy to FDA percent been

reporting in an will twenty this once XX:XX reported physician quarter We on of open In be open weeks. into and from various complete two. inflammatory two sixteen the to receive have extracellular and twenty label for active they remain fourth track from twenty trial clinic EDPXXXX All XX:XX this weeks opportunity patients first dosing. join collecting the extension We addition, anticipate in label patient placebo EV trial twenty two. Patients we'll the or up of results diseases outcomes. on bring extension will in candidate our for the vesicles EDPXXXX fifty to to

of threatening II/III TACTIC-E hospitalized safety goal complications recruit data patients futility is UK. target hand to monitoring to including is TACTIC-E, on the patients in and treatment recruitment Phase committee. evaluating associated not of of the U.S. It Brazil, and trigger will one COVID-nineteen close closing prevention XX:XX and three decided in XX:XX trial safety India. to in hundred Mexico back of patients COVID-nineteen TACTIC-E infection. in understanding for patients make smaller initial and smaller it hospitalized treatment by very remarks. clear close that COVID-nineteen the focus we our continue with five Phase patients. II the EDPXXXX. trial of EDPXXXX We meaningful of progressing to in Based and independent the on and to efficacy contribution life in twenty well trial a the initial our this now the trial, progress XX:XX recruitment Hitting with an arms efforts will and analysis is scale of Simba hospitalized the have our EDPXXXX of the for and this each I'll the interim

Simba Gill

Jonathan. is We concept now pivotal Thank you, SINTAX. for Phase moment This have a for of II study from Evelo. proof XX:XX a

in second EDPXXXX EDPXXXX anti-inflammatory is we're in and We are development our Phase And potential microbial In II parallel, study commercialization. in in product, dermatitis. the advancing EDPXXXX towards atopic advancing later stage a clinic. psoriasis

questions. a clinic towards to and from will the full and technical EV you grow breadth XX:XX Evelo preclinically vision. of can as better our SINTAX Thank have neuro you your strong attention, expect making the XX:XX better how more the platform now open All potential continue capture our medicines we Our platform, platform our and we we understanding for of inflammation. beginning, for much towards to progress and shown we is of SINTAX have is of in development the only this

Operator

Chris with coming line Instructions] the Howerton Jefferies. XX:XX [Operator from Our first of question

open. line is Your

Chris Howerton

you Good the thank for morning, very questions. everybody, Hi. and much taking XX:XX

be would both be would an of primary if I'd the be think regulatory within, company's kind secondarily, possible? I me, that what using be For I how study. first patient So EASI-XX cohort guess, of if hear on path as And compare Maybe atopic of B the question going And curious would to A? Phase endpoint clinically question endpoint population? to XX:XX then could the design to that then would that's just And effect on the you moving to inform size one. the forward Thank with meaningful respect such mild this two be psoriasis thoughts that to the respect and to is, a dermatitis. with you. III contrast moderate cohort it?

Simba Gill

is this Thanks for Chris, Simba. XX:XX your question.

Sorry, could you just repeat the last question?

Chris Howerton

XX:XX contrast last cohort results compare forward? for question Yes, and And out the cohort study? the in sorry, exactly was, psoriasis you of and the is cohort help III B Phase B design to A moving what kind the figure going

Simba Gill

All Okay. XX:XX Thanks. right.

me let on effect one meaningful be the a what EASI-XX would was, side. which So first, middle take clinically

not steroids. of know including atopic a to atopic patients mile and range treatments. taking moderate for limited and Chris, oral are have you essentially disease [indiscernible] any does As with [indiscernible] dermatitis And approved moderate dermatitis patients mild

with over question. a five twenty as than XX:XX an a drug have have we patients a to percent of effective we to attractive We bar have or that, confirm I'll and that doing In well and to as of of better reason percentage would more good in oral And long your limitations. attractive a drug. thirty the tolerated I have general we drug. percent Chris, hand guidance EASI-XX if number is a see safety expect psoriasis greater can EASI-XX responses [indiscernible] probability or leading Duncan say patients equivalent, tolerability, of who very in We as XX:XX the continue we to XX:XX similar first we we somewhat moment The I'm that. Chris. low answer very actually for than you, reasonable or have

If had see did end you level eight at or treatment. PASI-XX after in only that in dermatitis we greater plus confident diseases, better, think that our psoriasis minus I’d already up. even get of Phase of or we'll level that where data XX:XX to now are about. we're we So already certainly terms who EASI-XX also it's feeling at talked we weeks right in emphasize sixteen biology, encouraging that atopic look at of Ib we may out seven some different Chris, patients that PASI-XX. I but or Different patients

first the on let Chris. question And Duncan your that's I'll endpoint. then as answer point, EASI-XX a So regulatory

Duncan McHale

Chris, Yes. [indiscernible]. XX:XX

So the authorities well the familiar scale, very are established EV is with. it's that scale

it mild will terms benchmark with fact that a disease some moderate and to patients is meaningful clearly change In of itself, clinically sever benefit notice EASI-XX ing the from.

So, we scale about regulator perspective. have we'll that II concerns Phase a remember from But look the no at study. also as

We [indiscernible] the key of IGA we sort BSA will BSA. have is and have to also will endpoints. factor

pretty endpoint is benefit that discussions well will will all atopic well But which we the all the what particularly EASI best So a endpoints established point do then validated the regulations those the don't to expect authorities. of have EDPXXXX those actually we understand data, to with we'll is we from and have health concerns go we result of in capture mild EASI. will are look at of end that of is and the to moderate any dermatitis, and very

Simba Gill

do Part B the Jonathan, [indiscernible]? to want XX:XX do And you versus then

Jonathan Zung

Sure. XX:XX

us II breadth the be A, the to year B important extending right? So, for be capture Part from Obviously and XXXX. psoriasis pathway, inform six looking our full how at we've clearly registration of maintained. then be to B part out we another around incorporated longer of think will it months the is next the dosing, Chris, study most When mentioned going about about along that'll an for a We'll benefit Phase certainly think we bata Part so longer dosing before, in relapse, will six study activity be this the but get as data. in weren’t whole as the we months we endpoint, data. thinking, likely at of

will the that So behind I the thinking A. is Part support think real data that

Chris Howerton

Thanks. XX:XX

-- Okay

Simba Gill

do want you – to XX:XX Mark, add

Mark Plinio

just the wanted we just XX:XX the same for A clarity of is carried the cohort. to didn't that impression Just Part point over a looking separate sure went Chris, make of separate into It's B a you had at we from that of on one -- I Part study cohort patients that not one patients point longer. B. for is, cohort were

Chris Howerton

maybe XX:XX I appreciate helpful. a I Yes. my the in chance, people questions. No, is taking back I'll but And you queue hop and appreciate clarification. that give the other

Simba Gill

Chris. Thanks, XX:XX

Operator

XX:XX line coming Luchini of question from Thank next with Capital. you. And the BMO our Matthew

open. is line Your

Matthew Luchini

taking morning, and on XX:XX continued So, the Hi. very Part the guys. B Thank XX:XX maybe you much progress. the on psoriasis. for Good congrats first questions

of on provide well? will the if just to for are more point, preliminary able everyone secondarily, XXXX, data sixteen of data perspective the looking much. week And your concrete have data formulation to will inform months that not able more where? and when efforts and additional I the talked to know maybe understand about able have challenges you on importance update. to strategy then Thank work only beyond some little expect any XX:XX weeks, for you which to something and AD seen could the that about beyond broadly a maybe on lastly, at six but drug, the you here? if median EDPXXXX since this be when as recruitment And level how development your you be want you around just to color may last somewhere provide follow-up you've more say the then will incremental Given everything And of be sixteen below if the you're that, so, or are release

Simba Gill

wave those QX of formulation, detailed XX:XX I'll let data couple take of take on of So, questions Jonathan that the Part we B. and me year. next next On the level XX:XX expect understanding of in and next have we'll let a

track on that on think be front. we that I should for So

Mark Plinio

definitely the for additional Jonathan want We XX:XX XX:XX but on It that may you than have then, don't to And now. being recruited why know don't situation. exactly COVID really expected. slower do try UK, of been recruitment on that been because the stage to right we're positive trying XXXX, and that that COVID, talk to understand there's a us, we information details B? recruitment it at understand any On it's of about rise patients. known, we're had have could math, Part this study be probably We of in you is

Jonathan Zung

Yes. XX:XX

and Part the one in study. an into for It out twenty have B, goes that So, who additional have weeks. of rolled twenty subjects portion four we hundred

will go We proportion twenty next who got percent twenty subjects year. And expect that We've seventy who completing subjects of in a to about large of data completing fair we'll are be report of we'll have have those the plus full now weeks. those subjects a first who out number to the and quarter will what week. in the

Matthew Luchini

into dermatitis? culminate actually you XX:XX Great. atopic XXXX to want And then Duncan, do

Duncan McHale

it’s from because Matt, that to Yes. we very good atopic got we effect. kind that dermatitis early that valuable reusing a I here suggest useful inflammatory clear, actually XX:XX be question. indication a is and

there that plan talked here is the information. to effect that the such have obviously say development will same an [indiscernible] is effect is XXXX and we of to Ib another indications indications. want range demonstrate bowel Phase is is the the diseases to other a exactly to actually drug managing not immuno demonstrate then diseases as The as inflammatory study We and XXXX about good safety XXXX. then This plans neuro future the key that intent data just and inflammatory classic but will disease follow the like obviously the involve well, tolerability footsteps will to as range anti-inflammatory we before, the whole

Matthew Luchini

the XX:XX questions. for Okay. Thank you taking

Simba Gill

XX:XX Thank you, Matt.

Operator

Our question Kristen from of XX:XX Cantor next the line Kluska coming with Fitzgerald.

open. is line Your

Kristen Kluska

good Thanks morning, questions. for the taking Hi, XX:XX everyone.

most that one further have are dermatitis. the and comorbidities first noticed with expands in atopic corporate psoriasis deck associated recent that your emphasizes I The is, specifically of some I

dataset your enroll as as Phase even if look the was you in you II starting to study of are dermatitis, important some near potential are Curious SINTAX will broad medicine. understand the these your atopic of of understanding apparent comorbidities systemic impact? to some perhaps better the of for more where So recent patients some

Simba Gill

Yes. XX:XX

to context. it specifically up point. the Phase to the in So for in skin comorbid with comorbidities, diseases that And detailed of I types Kristen, conditions systemic to you're have XX:XX question not suggest on breadth many SINTAX dermatitis Kristen atopic there's more in on looking that fundamental different for psoriasis anyway picking things is, be are different thanks up that analysis, inflammation, beyond B, obviously we huge as obviously of on that multiple treat XXXX won't pick We be just patients the up we'll looking the But point with think both dimensions. A. picking your degree II, and opportunity impact, the those recruit

So II. we the as go Phase is, one important of we forward. the won't point terms potential recruitment in treatment an be looking specifically for that, in no But

Kristen Kluska

it’s expansion might on the observed Based trends the whether with and some of at similar you've or term looking And between dosage EDPXXXX. EDPXXXX these differences with you And you Thanks. the something patent the differences profile to for on Wondering term XX:XX had, both? then here, excuse candidates, EDPXXXX. see in Okay. do based look in the [indiscernible], as longer think about as off me, post expect XX:XX with longer these greater recent opportunities preclinical EDPXXXX? address as you could of well findings light think you given EDPXXXX, EV recent focus how

Simba Gill

Yes. XX:XX

questions. think of So, I three level

human first all, of different need those see different. with to we if versus or responses XXXX are similar clinical So data XXXX see we

the difference. preclinically so And are they

able XXXX So and future, that EV Kristen. of data terms about not we how expansion hopefully, In think we'll then be of the update to XXXX, question side in XX:XX things. answer with

of have today of worked me the where historically earlier antibodies. about discovery and as cytokine Kristen, Mark worked, first it I uncovering the ago, antibody started Mark [indiscernible] first and who to equivalent [indiscernible] let I What that talked headed even you as see decade groups. think cytokine together. when talked know, company now. of we biology fairly the biology, that, are stage I up central antibodies I we've human been on other remarkable is to about in [indiscernible] with take engineering have we flight recovery in world,

little XX:XX what more We to potential the more about we and start Mark But of the early of thing much platform. now. how the right And understand are this SINTAX EV forward, I’ll is. more of say pushing bit as in very a potential works, as days uncovering the biology

too now like SINTAX real well And EVs us of very too safe, future said, orally EV data we Mark a our being the signs affordable. right and efficacy ultimate not agents whilst point to have sometime see as and the a that on antibody being in all being opportunity far and tolerated distant call. have away. As of delivered in said of platform a not first it's that an future We'll direction have populated, as we the

psoriasis dramatically looking drug that's our first But follow-ons have really other any in have formal EVs in year at attractive this cellular and [indiscernible] And go bermatitis. extra track in that's an of be good EVs guidance rapid pretty with XXXX as the We probably as atopic but away. terms quickly versus now, In that like quite indeed on microbial going XX:XX it have, of that next date far look And won't we and potency. the see wave where inflammation. to Right you or when and out, we are into XXXX we a microbes better read actually. clinic will XX:XX too know, can that's but XXXX so of we XXXX.

of inflammatory again As you looking side already XXXX as today, interesting. newer about is Mark know, talked very the and

as atopic depending way patients in quick said, out like to we see Mark, Duncan move but as have always and your a be that remind we great we other to see for of we number is XX:XX XXXX will and areas. it XXXX we dermatitis potential getting in as would data, atopic nuro then information human of how how As on example, lucky XXXX a drug. Necessarily dermatitis in don't And everybody who figure products. for as an XXXX, then inflammation well clinical forward

do if luxury possibility fast. obviously, up Kristen look that So, forward to end we and it’s we great

actually I’ll the that of bit pointing possibility. now helpful. say was little Because exciting that things. a is an about, side your signs I more said, right Mark hopefully being EV to us as incredibly So, all have

Mark Plinio

Simba. XX:XX set and with Thanks into Yes. that Kristen, the XXXX effect. your about XXXX to first the And let question duration of of and play

said, but don't we clinically, As Simba preclinical know do. we

like the we then in been in various we've a at a of the drugs. our gut at level. work background, lot that that say that discovery, We the in it these of transferred We've exactly untreated pharmacological It receptors, pathways the So with XX:XX be actions EDPXXXX is that that primary differences way there's the regulatory the reduction take specific molecular to differences different on targets, micro doing but And look lot which in of the the and increased it driving induces could it does in is at pathway pharmacological can identified can which treated is things. the research underlies current there of a [indiscernible] common different microbe, fascinating, to this we [indiscernible] molecular same by animals -- It but EDPXXXX. part. is by vesicles lower parts not also phenotype as different does the doesn't does a But in extracellular because here look were EDPXXXX. of much molecular agents. EV animals some of look which to exactly

get from to a it media point think also exactly and the these of you some movement of driving have things in my was So of the comments about packing. to dose target this if the of view, efficiency about gut

a animal from orders ten of did to take the down about we cells And magnitude, per smaller We typically EV time. of nine with So, model several XXXX. day an six, the ten ten the EDP seven. that at the dose the to microbial that's same in can

about got disease. this preparations, which future is the additional microbial of base and why into of extraordinary fold. differential that's -- So we've potential a mean is to the forward, quite why I about get go have then to so severe the way efficacy with to talked excited we a an we're I the fact, platform, about the EV is million this because get

the range all now to given of taxonomic target. So the And quite relation just to molecular discovery of from critically as get is I we is Then the in going it territory. our drug patenting way, the this are vesicles on the comparing focused get dose the inventory on formulation, relation wide the extracellular from supports pharmacology response reemphasize to in of all microbes of that is that that's the use patent [indiscernible] to the about a and dose breadth claim concentration And suspect extracellular of to vesicles future which pipeline. most a microbes virgin brief spectrum, at support XX:XX [indiscernible] this. treatments the just the underlying by to mechanisms XX:XX around very looking around of where work we that is importantly

Nothing issued of patent And broadly on the product But gives filing. candidates so us for the yet, support course. us of fighting those we're breadth that. work very also which discovery the gives

that to a context hope thing. whole give So of to the I bit helps

Kristen Kluska

and Simba you, Thank Mark. Yes. XX:XX

Simba Gill

XX:XX Thanks, Kristen.

Operator

the And line of next Singh Gobind our from question XX:XX coming with JMP.

is open. Your line

Gobind Singh

for XX:XX taking Hi, thanks the questions.

just few So a from me.

bring I conversation wanted back results. think to the Mark the to had – I you

of just PASI presented I kind seems looks traditional and think a like five any five if presented ever of Amgen there things percent to five and you've even trying below from any? greater has trial. from than I'm results really or that the is, just have what BSA [indiscernible] fifty think I comparator figure advanced percent mentioned It the the is with out those or trials. compared different seventy It of advanced to PASI how there's PASI the don't of done trials. other kind way

context some those that's. give to then after how and follow-up kind maybe you view us results, one to of can So

Simba Gill

Duncan, ahead. go XX:XX

Duncan McHale

question. Yes. Gobind, thanks for the

they on So, chose [indiscernible] advance. as really particular Obviously, they -- that chose. I endpoint I'm are why Amgen can't comment there

those that perspective, mile, are that are sort In percent in the five say surface percent of in moderate. that mild mild clear at one, to and It's ability and to looked skin. clear disease. mild of the clear terms is that's that’s that surface five greater two so reason assuming In terms and or true you it get and necessarily XX:XX they they sort percent. from can both five of than as can which not one is zero a sort less using that of we've the PGA of And to nearly done PGA or from physician patient in disease. way clear and of actually result really it's than EDPXXXX that. I’m versus threshold of moderate also psoriasis the PGA the people cut settings, placebo reaching the nearly in it’s moderate body in ways which into -- we moderate classified We've is percent And use, at five And body the another perspective, similar we done of skin the significant statistically of both something three, saw, have disease. categorizing

We didn’t the is used they to it what of five the that clear clear the you but patients, study. endpoint tell from because EDPXXXX or another look and XX:XX case. endpoint. Amgen because -- We what of seeing skin. well the meaningful patient [indiscernible] that we later propose So and one authorities But development can't just validated and best way activity, the view targets [indiscernible] terms had set, getting at get use that's truly that’s it’s in our they perspective, a benefit stage skin want clinical obviously in a early it's we're did, capturing I EDP to decide that's or we with health the we of about to and hard at looking virtually clinically benefit terms thinking to it in usually in XXX clear used all percent quite the oral which sort XXXX will of we’ll the to six, a -- is of why will it, a well-established,

Simba Gill

Gobind. well, what underlying data. showed you this robustness understand was PASI-XX to that just comment very in was the Can [indiscernible] XX:XX add Actually important one of the I

well. it reinforced So it [indiscernible] comparatively was primary looking the effect from the an at question was that is but PASI-XX. responders, different the with like the This IGA and separate analysis a the as picked is at dataset proportion up BSA the looking collected that of there PASI of I EDPXXXX. This and fact

of a EDPXXXX. really estimation us in robustness the it in of our of for added study our So, deal evaluation the of effect

Gobind Singh

with than population? [indiscernible] you I'm clearly the pictures there the Ten about anyway. that And know underlying pathway, five a DOQI Bayesian was I XX:XX is guys are we're percent, there follow-up percent you PSI. lower, I'm guys effect, percent we a disease maybe the clinical not then small probably So mean PASI I would and and that And confirm I statistically like significant with presented those what? normalizing about shutting [indiscernible] being the more population process. the having of the mention off less guess, BSA are pretty Can at be drug, looking the twenty I Analysis. PGA your That's it's not with and earlier numbers helpful. assuming and

Tesla it's So or for to maybe PGA advance of example, one there be think peak I might Jack, comment, or guys this? the of how for take. in Like effect can long this might not the if for any kind be more a time see or And not way metric, precedent is focusing or other than example, any different see time for small don't good. rationale then you able this with know thirteen imagine molecule at you on are And PASI. responses to could they right because like DOQI PASI be I DOQI is looking enough week, and the pretty us that to PGA the was presented maybe the

Simba Gill

XX:XX Yes.

Duncan then expand Gobind. things and say can me a Let few just

today, really talked antibodies show that cell of our that immune elegant molecules. impact driven the So, our of important on the fact been transfer first preclinical very versus studies effects And he a molecules we've impact from of small adopters action. in about Mark's small you all, cell point raised are that or classic versus comments mechanism

back then longer immune immune the [indiscernible] immune that's down effects. potential lot positive part system because got. That system, to completely So a status saying be is healthy may obviously is system through than part [indiscernible] kick take else we're foe to And having system. sustained in it's XX:XX what will and for better the well that the do. you small longer. also over [indiscernible] of is cellular XX:XX of looking the little anything we're Very pushing B on a a effects shutting part regulatory immune means which bit essentially antibodies in it molecule effects what suggest for As implications likely

question quantitatively it’s answer So with the weeks things very and continued dosing. the us. twenty from positive see release weeks of are the Phase initial your all already II right we can't those data depth on out reported a seen response to this certainly We that twenty time, – we for study psoriasis we post

don't So that that cellular just process? there. is And XX:XX but and few the already it other indicative weeks a Duncan, after yet. of a then have comments answer So, likely initial dosing, for effect we you we presumably persist stop quantified can continues

Duncan McHale

XX:XX Yeah.

Just that. on a of couple points

So one a is This -- we when data benefit still it's being or be actually by that just that set split PGA but when significant. clear, at looked can sub sort being the look just reasonable just a and to we looking split across both at or the at BSA statistically three. that it's study, What two zero starting II baseline groups, as phase you we I very is, they to talked were a PGA guide, the by about of to. start

are of less we in data done than than look The either that looked the as the divided being not those analyze cases the into you percent, two a which we it's actually to where them clear nice you earlier with clear clear agent to statistically endpoint we'll last it's but think greater total trial. way so on account BSA subsets, well-established sort we and at the essentially In we've later all kind the say be we'll what it a go two It's take baseline shift, into means you, actually that of baseline PGA [indiscernible] they of and thing which each in psoriasis looked we variable population, percent as we XXXX forward, the the is later can get and keep clearing So the later and Benny five is what data. of And kinetics will clearing of look of we the the transportation would terms of fact. actually see the response psoriasis we the Chief for and of -- actually if at XX:XX as endpoint centrally tend of that individual very things those about I significant what five or either is, one Investigator to in way [indiscernible], when the at what is thing a or flat one the continuing -- to see analyses. results. two EGP at process fascinating clearing best

Duncan McHale

Can to mechanism comment inhibition. related effects of just what Because of senator add Gobind the Simba said you duration the XX:XX versus a action. the I actually hyperscale one about question asking are of in factor the about

that’s generating has imagine it's inflammatory not taken out that one But instance, on immune drive a for drivers the driven direct and the system, and long of if and XX:XX So remapping or puts inhibitors ILXX that inflammatory as inhibitor a by its TNF, response takes function. away. an as

durability So a be while less. the will the maybe effect quicker, bit

cord, or is, things logical an inflamed So got one we whether our joint, spinal view imagine here an skin it of the inflamed inflamed whatever psoriasis point it of is. to from dermatitis or

direct why talks have long been This You've over with that a where the the the inflammatory got effect that's the at is process years. replacement inflammatory therapy suppressed bunch effects. displaced. and term been inflammatory that of the there, in reprogram be need cells time about [indiscernible] cells. in steady has inflamed Simba or of you've grail which resident is regulatory where the lose inflammatory are by different And if tissue here got we're anti is to cells inhibitor XX:XX there's a What Now, a inflammatory of cells resident the for a looking holy drug.

to how at get know haven't it. We

is transfer thinks mean was accrual of the the in imagine and comment mice saw eye real I effective us. remarks can about the adopted in for was you effects I we in opener This the scripted what that humans. continuing why changing So the want way a in so not known saw we cell to That for of just profoundly immune made area but out its controls can we suppress haven't system, own how wanted something do that the do but inflammatory do to it an which Certainly to system, to response decades, reprogram the the science. response. we it. we figured about

and it reads telling seen can direct on we're is seeing it methods that what are clinically, us preclinical by very which So clearly the to show what happening we're preclinical consistent data clinically. with we is are what

Gobind Singh

XX:XX Thank you.

Simba Gill

Thanks, XX:XX question. Gobind. Appreciate the

Operator

Nakae XX:XX from Keay And our next question is open. the of line Chardan.Your from line coming

Keay Nakae

XX:XX Thank you.

think on me coating are Let understood. effort the the release just kinetics. drill further improve Obviously, down to I chemistries well

what's initiative? that the item gating So really of

Simba Gill

test the So, to touched model that briefly the on we on call. just supply we're generating the last in wave next for key formulations earnings

And supply. formulations as to we So in I we said, be just test QX. should generated ready different

Keay Nakae

XX:XX Okay. Thank questions All answered. other my were you.

Operator

Cowen. XX:XX And our Thome next question at coming from the line Joseph

open. Your line is

Joseph Thome

can be terms placebo starting is QX atopic dermatitis also into on be well? Is superiority, we're be drug able we a And will seeing traditional interesting, know XX:XX work, atopic the the P one expect you're the reach a more if other analysis on Phase but Second, with disproportion patients or a see. data kind taking the for in for here that of questions. Phase that maybe pivotal got that to the formulations comparison of be you terms way cutoff. traditional Maybe that PASI with II any What is for novel Phase that you will cohort a the certain in value move the is of add versus a we the the dermatitis ready dermatitis, comparison clarification data data first should readout then to this there or morning then in atopic sort studies the is readouts appropriate EASI-XX Good going II thank I to just as for saw would II Phase and what the path on there for II the these to formulations expand used formulation QX. novel of XX:XX supported? is Thanks.

Simba Gill

answer XX:XX about Duncan I'm let those questions. to going

Duncan McHale

less XX:XX side. approaches to For of approach that a the -- well EASI-XX. it Actually that reach number because proportion more is that question established a we use is and the straightforward basing analysis that to subject we the traditional from will

formulation that. to be the I a do technical In add robust Phase that think have of and for you, very able terms to analysis new to would potential of II. XX:XX part that of sort sort difficult a to be

potential trying So run study. a in and study current than new will any rather we formulations the complicated separate

Joseph Thome

Thank XX:XX Great. you.

Simba Gill

hasn't that XX:XX stopped on expert pass. from the So, Joe, I [indiscernible] becoming you future hope an basis

three [indiscernible] the people probably statistics comment Joe. So old, for hundred basically but which years try just anyway, to is we day, my educate that's

Joseph Thome

XX:XX Thank you much. very

Operator

over the this remarks. showing questions turn closing further at back now call would to time. any our no for I I'm speakers like to XX:XX

Simba Gill

Thank everybody for all and for attention questions. Thanks XX:XX your you, analyst their their attention. to wonderful excellent

As we said in the us. moment for scripted remarks, this is pivotal a

just to but non about we future everybody talked an microbes I uncover XX:XX thrilled we but first tax property, first therapeutics. in of the is think already true platform. as small pioneers, to company II intellectual with Mark We're the We delivered were that live intestine. the incredibly are exciting extracellular absolutely what remind of see are company the as using the we the will for psoriasis, beginning Phase

vehicles. to microbial think the orally We he's are my selling company about delivered are first the

moment with very clinical harness to So for. the well And the very how Thanks which everyone. central the we small leader know exciting and intestinal value forever. is still a the plays know of think be tolerated we extremely now that by access by appreciated pioneer effects an clinical not widely always some the capture goal a to much that safe. And something access, is And can community. even role absolutely about as been test scientific to for exploring we now

Operator

today XX:XX Ladies and you gentlemen your participation. thank for

may disconnect. You now

Evelo Biosciences (EVLO) 28 Oct 212021 Q3 Earnings call transcript