MCRB - Earnings call transcript Q3 2017 | Seres Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the third quarter 2017 Seres Therapeutics, Inc. earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions].

call Seres recorded Therapeutics this available will reminder, the in website. a is and being be As I would now to Dr. like to turn the call over Carlo Investor of Tanzi, Relations. Head

Carlo Tanzi

prepared our release quarter Thank information our the available Investors can at the I'd Time a A our our to be ulcerative and good development non-immunosuppressive & Eastern development you became We've to materially. value of approval potential therapeutics; on press of studies; will website. AM our for microbiome our various remind plans morning and progress update patients; study colitis of timing for company's product offer SER-XXX financial XXXX for and treatment to this third making X results the option clinical that promise found of remarks. potential therapeutic and may slides company's will for candidates; potential a morning. website Media the with differ impact and discussed data accompany you relating SER-XXX.Actual the section candidates; posted also results the the that be novel in statements like results SER-XXX we for forward-looking on the progress the the and registration other of of of or the

by and Chief Pomerantz, President, future, Officer. We made I'm so. disclaim Factors today's any statements Roger only. call Additionally, today's today may we Risk obligation recent Seres' to but joined do of section, which as forward-looking the Chairman, On on Financial the certain views are under Eric update and statements our statements to subject filings. are these call, risks and CEO represent discussed uncertainties, Shaff, in these of Dr. SEC our Any

during Our of question-and-answer portion call. Officer, David available be the Dr. Cook, the Chief also will Scientific

Evercore XXth be this XX. mention the in a Before including Stifel Roger, upcoming like on participating the later conference the also call on month, Piper the in conference Jaffray we'll I'll I call Roger. on to York, in investor to I'd pass to XXth ISI of and Boston New now York, in pass number New November

Roger Pomerantz

indicate Thanks, joining play disease our Seres made on for We efforts pipeline. a for is our role. all important, has advancing areas microbiome developing immuno-oncology. our positive were to states target an efforts thank microbiome such has provide Carlo. data the with obtained data microbiome therapeutics clinical potential notably gastrointestinal us. immune in serious Seres' our multiple progress substantial advance central metabolic microbiome new and will excellent dysbiosis focused including diseases, pipeline, progress preclinical diseases in and R&D to as to is I today's diseases therapeutic call, most And is infectious we human and/or of that SER-XXX. address on and the believe that you On the thought the therapeutics Seres diseases, including where update compelling inflammatory

healthy array human orally-administered, natural, let's with in is spore the reside that commensal So, SER-XXX. an form biologically-sourced bacteria species gastrointestinal comprised candidate begin of wide of a drug in of tract. SER-XXX

subjects, into for human conditions germination manufacturing reach been four least advanced the transplants, patients. hardy transplants from are studies the physiologically where donor Our of microbiota Repetitive evaluated benefit spores or at and have colon in These they randomized, fecal FMPs, of placebo-controlled studies Both microbiota indicated the fecal colitis inactive process active state. and clinical preclinical would spore they that bacterial isolates until have ulcerative metabolically purifies action transform material. a XX double-blind, randomized, the announced the standard who results trial the positive to clinical Last remission their role clinical with ulcerative active and moderate SER-XXX and the supporting colitis. with placebo-controlled, therapy. mild efficacy lead ulcerative patients Phase that in colitis Ib strong a evidence ulcerative we was demonstrated. study, microbiome microbiome can multiple from of were This in of month, clinical colitis, dose shows modulation failing provide to

were As pretreatment, three a dosing arm arms weekly and treatment at and were study of study's The score vancomycin rectal objectivity seen collected included end with pretreatment. on listed a arm arm The a at measures is placebo the methods illustrated weekly arms on a arm. to stool slide statistical efficacy are pretreatment on of reader. daily slide endoscopic maximize evaluation, were to blinded assessed In recordings assigned all SER-XXX Mayo six. physician's order a bleeding, central in with evaluated modified SER-XXX were analyze Mayo a all or used on one four, SER-XXX of baseline endpoints five. based to outcomes. Total assessment, endoscopic These slide dosing subjects evaluation. intend-to-treat of The are scores subjects by endoscopy Ib vancomycin frequency, the a global Two the prespecified, treatment. dosing and Phase

second both highest all the missing failure. rates vancomycin the pretreatment in and method SER-XXX Analyses arm observed and efficacy demonstrated remission each a in was clinical scores. analyzed the as improvement study. analyzed first dose-dependent counted endoscopic data of The resulted from observed daily that approach SER-XXX of data administration The

patients a data achieved XX this XX a X or had XX% on or protocol analysis remission, seen the the slide based actually of The patients violation. achieved placebo study placebo only flare an As in arm, and seven, during in steroids, endpoint on reached remission patient while who group. of single observed this received X intend-to-treat XX%

remission patient approach patient remission clinical as counted because study, observed a However, was this protocol. the end the they at of in violated the even though the prespecified data

remission. counted initial statistically in X of now of failure. this under data other subjects this X.XXXX. in p But XX reached Now, to missing eight, slide value result Again, prespecified moving X%, significant clinical as XX% with the method, of Even zero rather compared group. study, the or modestly-sized was placebo a to XX

that statistical direct compelling similar also placebo of arms. clinical analyses. Based on response now response also were on UC. the response study. remission high effects treatment XXXX FDA's rates treatment data observed I high observed and the clinical the response endpoint endpoint, from We August discuss endpoint, not variability. endpoint regulatory In wanted in we to both Clinical of the addition rates and saw clinical differentiated to in recommends from not the magnitude primary the guidance XXX in clinical the clinical registrational is in for as clinical measures the of remission use a response drawbacks prone to subjective the a studies all latest endoscopic

mechanisms modestly-sized believe that are drugs in been colitis data As studies, to clinical very such, high interpret response action. demonstrated placebo several in Phase in particularly using II of clearly difficult We rates diverse from in response study. have trials clinical previous interpreting any UC rates ulcerative when with

the our on bleeding frequency on endoscopies zero the initiated, defined that Now, after and new prior slide new be part on or made requires recent score FDA was subscore. most modifications guidance seen implemented protocol have SER-XXX nine. of of achieved, clinical subject a clinical as both zero rectal be remission were Because subscores the one the Mayo to the were study FDA's analyses stool and based can FDA in to statistical The guidance, a remission. on the for definition guidance standards. These this a must was

FDA guidance this new the observed as remission. improvement the counted is with new were of compelling. missing and the results increased daily guidance, associated FDA the missing for analyzed SER-XXX guidance, data can efficacy remission analyzed data however, the per in using the included of When our seen is be as guidance. in data have, the improvement both data analyses study SER-XXX results slides remission significant is new results level XX case on This endoscopic rates analyzed daily highly defining the We Indeed, Interestingly, arm. endoscopic based improvement These with new statistically failure seen analyzed XX. our rates also when on FDA and clinical the under statistical remain arm clinical FDA and endpoint study failure are analyses. the significance clinical the SER-XXX both counted analyses the the when definition the in

not clinical primary under recommended response As as nor previously new the defined mentioned, is FDA guidance. endpoint a

favorable. The adverse was the in SER-XXX to as were Now, arm SER-XXX drug-related serious patients treated to there safety with very compared imbalance placebo no and the and demonstrated SER-XXX moving in no safety. SER-XXX. adverse Results associated on events tolerability profile events

to that subjects the with a placebo. line evidence also impact SER-XXX independent arm GI-related daily adverse this in of observed additional interestingly, fewer those pointing we than SER-XXX on activity. beneficial dosing represents believe an experienced And Now, treated events disease we

point If website. additional slides you on in information, to are detailed you interested I our available results are would that study the

help including coming the including could provide into SER-XXX's study, future mechanism to look SER-XXX months. SER-XXX analyses, data were forward histology these and and additional and the products, believe Ib the continue biomarkers synthetic very program. from further important Overall, our inform other fully we results. in We efforts data Phase SER-XXX XXX development detailed the pleased microbiome of with We Ib development insights could to of phase action follow-on

available Our and a often entirely mechanistic a to orally option, that SER-XXX objective that novel need provide with SER-XXX is hope new is administered is is Ulcerative not mechanistic is effective, condition for all importantly will debilitating treatments. approaches therapeutic is highly develop refractory to highly which high our a it There immunosuppressive. colitis an approach.

FDA maximizes that to intend data. to the considering optimal for now once next with a are SER-XXX. development determine the We we meet the plan steps We remaining study obtain development

program patients with C. to diff III Now, our SER-XXX moving infection. for recurrent Phase multiply

to enrolling sites continued make have progress actively and clinical We adding patients.

we and FDA emerging Seres Health efficacy trial primarily approval. In also forward microbiome as notable in and deep Phase SER-XXX Based file active Phase Phase persuasive Ib We tolerability single and therapeutic the from diff make weeks. US that safety to SER-XXX changes. Canada with infection. able driving designations a the an designed, have C. modality. also as fermentation-generated the expect pharmacodynamics rationally Seres pharmacokinetics candidate. progress multi-strain, results important the to the our it safety from drug by first-ever evaluate coming clinical SER-XXX is trial the in are in application received a expect with you, clinical study remind measured microbiome patients FDA, To first-in-human, SER-XXX both orphan continued interest III breakthrough this study, with study, evaluating in study therapeutic and obtained regulatory discussions clearance be this and has to recently and has clinical Canadian the of would dose-ranging primary on and we demonstrated also to is has that, SER-XXX sites for microbiome Ib

evaluate in XXXX. obtaining across Ib line top cohorts. early clinical also dose results will Phase the efficacy We SER-XXX anticipate trends We study

a liver diseases, clinical make programs, metabolic continue has three efforts, R&D advancing partnership the grant those antibacterial diseases stage earlier-stage million immuno-oncology. our up CARB-X preclinical to of $X.X Seres will from we and devoted inflammatory SER-XXX program. that CARB-X been novel a therapeutic our addition to approaches. to awarded in support our of to advancement In just public-private is in progress including diseases,

infections, designed data serious patients are in graft-versus-host than We stem SER-XXX, rates reduce more either developing have as microbiomes. supporting outcomes or diverse to healthier, who is both rationally transplantation. well clinical bacterial dysbiotic receive rationale gastrointestinal allogeneic as with a microbiomes The on those better with cell solid more showing of that composition organ SER-XXX patients based disease

our to support to finalize into call the we I'll study. intend a Eric financial move with to clinical the of And continue program pass of funds, now to this review will performance. the SER-XXX. We recent CARB-X composition

Eric Shaff

Thanks, everyone. of quarter in the compared net of same a for Roger. period XXXX XXXX. $X.X a reported third million million to the good as loss of $XX.X morning, for net loss And Seres

personnel primarily microbiome expenses, The ongoing development third by quarter clinical was driven development platform. the net expenses of loss and company's and therapeutics

cash that R&D figure third Science. III the was million development revenue our quarter Health revenue collaboration $XX initiation with with equivalents was $XX $X.X costs. approximately of call milestone III of for net in figure ended associated Health and million million, note cash, $XXX.X $X the offset ECOSPOR compared The of pass with million million year. Phase the The XXXX. General related administrative as the loss $XX over associated quarter the Nestlé $XX expenses the G&A for due recognized the costs programs. included with with the in facility development in inclusive as Seres' were Please and to were million Roger. development prior quarter $XX.X and balance $XX.X expenses platform, the period primarily of SER-XXX, operating compared was quarter clinical milestone Research preclinical million from for to professional as by quarter fees for third same as Science. the to third same now were headcount, million cash quarter expenses the for period study. partially million company's and during expense million immuno-oncology therapeutics investments. in SER-XXX in the SER-XXX, primarily Seres SER-XXX, to Nestlé microbiome the $X.X I'll the Seres' third the decrease to back SER-XXX, clinical well and

Roger Pomerantz

This obtained want but encouraging our perspective initiatives We a and continued a progress both microbiome as promising the more also on study data of Seres, to and execution colitis pipeline, company data. advancing future including of believe additional now provide the efforts, for studies broadly SER-XXX been field. some its immuno-oncology. are in period the Ib I for stage ulcerative meaningfully in the therapy, potential progress exciting these SER-XXX results, advanced has important earlier SER-XXX SER-XXX Phase had R&D our where

subsets provides chronic support micro medicine. diseases. colon, T the the We for these datasets to treatment areas regulatory reservoir in in is essence, promise results for data note, colitis, a but Of biotherapeutics to of that approach diseases in body's largest SER-XXX this responses cells the potentially new checkpoint first-ever that as alter specific capability compositions of demonstrating therapeutics including microbiome for immuno-oncology. the autoimmune for the demonstrates broad inhibitors interdict target also with In therapeutic inflammatory ulcerative provide drugs ability immune cells, to additional cancer. of to only immune the not the which clinical modulate the as many of efficacy such the impact cell potential novel Our microbiome believe in potential in immune microbiome T for modality,

that further for that bacteria rationale inhibitor the may evidence last of in to therapeutic tuned demonstrated these microbiome provides development particularly in impact also found by the to will gastrointestinal responder microbiome is to benefit the Interestingly, data data to be comes of across transferred journal microbiome further Jennifer Please in We the of cancer further composition multiple a as from Science specific are and clinical that clinical Wargo the colleagues I Anderson interested design the and demonstrating additional our influence support observed bacterial news immuno-oncology response to the checkpoint favorable studies to melanoma We therapeutic related provide patients. just inhibitor this further in research a from therapy. preclinical of for elucidates checkpoint research The believe metastatic able provide I published as mentioned, mice. impact the area. therapeutic consortia a pipeline, published may that stay microbiome landmark the evaluate the to immuno-oncology. immuno-oncology MD response microbiome our patients also clinical in system. that evidence signature augment inhibitor for Also, microbiome SER-XXX properties the in we immunotherapy. including believe ability checkpoint mention immune week

Carlo Tanzi

for the up line questions. let's open Operator,

Operator

Instructions]. [Operator

Newman John from Canaccord. comes of question first Our

Roger Pomerantz

Good morning, John.

John Newman

question Good the on progress. morning. Thanks congrats and for taking my

meeting thinking trial at? of that there design terms look and patients like like focus in there more you groups will the the as that agency just discuss I'm study, curious. Roger, you curious forward? this know on you'd So, I'm with XXX specific at going point the be of to results endpoints I to of what to to but going you're that other just forward might Are

Roger Pomerantz

Yeah.

It's very for So, good a Obviously, good data, or for the what are this of trial thanks trials. next one. question. have a possibilities we the lot with

than but forward want do is will it be FDA. drug group trial various a earlier be not a That the Crohn's we drug this patients, alacrity with huge just we see stage patient me some groups some don't we early broaden on. into this move the And say changes, first patients. similar just thing the in meet to out rather moving There does patient, disease. later stage mean into likely want may of even for future Let that to with next

We drug, we patient this care, important. patients think so the moving which as group that is, are with But, is what non-immunosuppressive, indication. I've is this standard patients, we agency. And forward, which will who before, potential an be what's highly safe failing that, are pediatric will in discuss into going of orphan said interested which

that was think some by missed I people.

mild just not are moderate treating We to patients.

think are a to and, is standard medically, for against We other economically patients what if end keep the the patients very can We anti-monoclonal TNF both you fail but are mediators. could treating immunosuppressive think they they think limited drugs, and that most care, spot of who about mild to, are failing out pricing expensive, moderate might when And group add, lead of care. we agents patients, this when standard sweet and up of in immunosuppression agents to of that we including, importantly I be. not

we So, could that go. move forward. a drug there's this places will think We number of

We We population words like will, talk Obviously, we that agency very But, get though, much FDA's forward. made on as the focused of clinical has glad I the not endpoints stay failing designed and drugs wait again, patients as put think we'll colitis, therefore, and, move being is, forward. endoscopy. until a them. in drug SER-XXX, And mouth. to are remission but all such for you patient the also only this to real for never step we to we in objective more this this ulcerative study objective disease

John Newman

Okay. Great, thank you.

Roger Pomerantz

Good question.

Operator

from Oppenheimer. Breidenbach Mark of Our question comes next

line Your is open.

Mark Breidenbach

morning, good Hey, guys.

Roger Pomerantz

Mark. morning, Good

Mark Breidenbach

graft simply a ulcerative transiting dosing vancomycin on need could wondering they're just to effect, for are if I'm you possible strategy in really if the likely daily through it's you if while exerting maybe bugs or they're gut. comment the even proceed beneficial pretreatment? need with Roger, the So, for colitis, SER-XXX

Roger Pomerantz

We describing. but that, to have better or due it's something could so that it and data. think hand, before, We think nice when a put being once both think And the of said helped or not coming Another in understanding literature vancomycin, go we important safe there the humans. FMT microbiome data, reproduce in in forward. data whether clinical was believe able action for pretreatment, is the that we experiments, and effect, or that as decided a really since That days very in something microbiome said, first we that it – given to of we all, happened. we'll able The you because organism be which help what this that us we transit why either we all that the will microbiome Obviously, to know the is six are we not really some only be really effect. we for to of a we study hypothesis you're about orally preclinical some in to mechanism the are great will of like both question. FDA and as simply get as we is of have laboratories. what But the were it be clear when was engraftment in our will vancomycin biomarkers anecdotes best only understand the in vancomycin

know a sure to like with trial case. I drug is when And, But, is is, the don't forward to vancomycin for patients. design before it's as these absolutely didn't weekly FDA. we sure will or by like whether at you important we not the drug or As vancomycin. dosing, in the to actually be clear talking needed. look think difference seen combination again, would the I it make seem to that don't a but move might've the clearly, we you to data, But, obviously, be is that a there

Bayesian carefully isn't look sure discussions will say to it I FDA. it you'd necessary, just us but to probability, at able sort the of be Expect we'll as that the we with pretest you're make it's out. data at if vanco know put probably – And So, in that. looking together, with

Mark Breidenbach

of may, Okay, top to A course, of if line trial. this results placebo-controlled that's we're, the study on looking I SER-XXX question, helpful. the where second forward

XXX primary and to the us of settled how how tested FMT the dose trial ECOSPOR you recurrence, CDI current the that trial, of SER-XXX really just remind in XXX you used how Given the maximum compares in can isn't in that's being many III? dose doses of are widely used on size, being

Roger Pomerantz

Yeah.

So, that's great a really question.

on is ever note. seen and drug track guidance So, early my first different some first to important We've XXXX. SER-XXX about of synthetic the Remember, ever humans. what all, And that's patients, fermented this yeah, to holds we're given still synthetic first of still given groups publications to is. from drug.

we in a this from and XXX, safety since XXX biologically totally first two, microbiome together Ib made we synthetic fermenters, drugs dose, are only the other and ascending was FDA synthetic this both have put the The anaerobic obviously, looking XXX in is because efficacy a in the with first-in-man, as sourced, that space for at trial did different drug.

We engraftment in was interested and also engrafts what is in time this the the synthetic whether first a like looks used. and diversity the microbiome. are highly Again, this

So, you safety. look for

You for this up dose the then, which effects case is PK/PD, And microbiome. any set trial. on like in you ascending look

give what typical use do study are first-in-man doses case, trends try idea look to what us Obviously, really there You an much in see cohorts see you and trends. larger then, microbiome be in on Phase small, the cohorts the the different to because what in II general is the for are to inform be cohorts. trial. but will may likely And PK/PD safety efficacy of you a a each the in you

for look that. we'll So,

because only before, to seventh in we're with in forward. the we to from some moving learnings had root to ten and the As which dosing the not has has we analysis went said cause multiple the and cohorts those of the data fourth regimen, dosing been gotten increased XXX, ten

might will multiple the exactly said an but about area information we're give higher we're how we well as think Phase going, dosing look II like. with to that with as haven't us We comfortable high what extensions dosing as significant

Mark Breidenbach

next top with those Okay. data We'll specifics line get year? the

Roger Pomerantz

Absolutely.

Mark Breidenbach

you. Thank great. Okay,

Roger Pomerantz

Good you. Thank question.

Operator

question comes Partners. Joseph Schwartz of from Leerink next Our

open. line Your is

Joseph Schwartz

question. for Thanks taking Good morning. my

So, that first you'll doing learn data was of and you when more all, the talk what will about hope be see those hoping you analyses we XXX the I from could some results. these and on to

Roger Pomerantz

Yeah.

it's said question. So, I and – good obviously, a as

biomarkers about Let for both number during me just and it. as of be biopsy We've finished and We the serum think are well we both immunologically. and important. urine do as clear after that have microbiome course, trial. And, kinetics microbiome before both of We of the a and results stool being read, that therapy. have after the eight-week that's

or drug, I induction. for regimen. action, for guidepost what as and by We're not as up not study just have on just you future you is mechanism for well will our we the the of to treatment not changes longer How in they Pyrrhic daily in microbiome also do after As good induce are looking when next and but trial will a the be victory how maintenance after no maintenance to the the stopped. have weeks flares a any then if microbiome complement have might is looking maintenance, it. eight degradation looking said, come further with maybe at changes to the in

out to two is number compendium, a will We months. how immunologically mechanism Is think maintenance flares. deep regimen. month? We Is the be So, to the not are these it in weeks. a understanding drug can. and but not way to works, out get will action practically the conference wait will the medical to but both once it every for rapidly we be we'll data as also about week? patients in Street weeks? again next we we be it as important will Is as very reasonable coming of microbiome that once a a what XX a once it we these of that We're What it and want data microbiomically think bring do and for following just do from important get, in going and

Joseph Schwartz

failure the was been wondering more XXX then, the give the used And on insight just criteria was is program, running could us Thanks. enrollment the given III, you what into in have in than screen great. Okay, I Phase your how any if rigorous program. previous rates

Roger Pomerantz

Yeah.

put can We exactly surprised. failure the rate haven't I on ramps what it still say And is. want a because as yet it we've to being number not don't I said up. screen we're But been

Joseph Schwartz

questions. my taking for Thanks Okay.

Operator

next our Fitzgerald. question comes Tanner from Bill Cantor of And

is open. Your line

Roger Pomerantz

morning, Hey, Bill.

William Tanner

a How are you? questions. Roger. I of Morning, had couple

the And on today. a XXX. calls back had Just other I've couple on going

apologize I further potentially timeframe the Is from is as any you too think comment So, expect been enrolling you're it's it currently there that to that? to if some study addressed. or should rough to data we on that when really early try

Roger Pomerantz

Yeah.

I but microbiome. would on are Health actually one, but this we Canada it's just AEs. up. tell any from will a slope has We seen happy interim analysis. ramp think and totally there early. to want we're comment want now think on very I you the gotten drugs and there give to thoughtful And very Canada we the AEs. But, in several sites. us have obviously, these a hundred as patients comment, DSMB. that continue They study, have Canadian an time Canadian We, too We the of Remember, curve active previous little were no see been under before the opening sites. obviously, and active can don't side enrollment. and we that Health the more to an up XXX we interested can be to of I will This haven't is have have remember our no be we international DSMB. trial. you safety We've

William Tanner

might an maybe form eye persuasive, know in Got they is the if were definition it. an the understanding then, if the mentioned And it's that beholder, a or persuasive, that approval. if for you a don't ask basis effect. to the And it's you, that maybe treatment data if it I there's for the of unfair minimal there's

Roger Pomerantz

We medical, effect. for thinking significance. We're are not There a minimal clinical significance, statistical there. a only hoping is for not but treatment difference

a to diff. example the that an which cytotoxin I as me drug Let helped of monoclonals use is the C. Merck develop,

remember, Phase And two not C. X,XXX and you recurrent that in there for all patients. significance. It Phase enormous As IIIs of XXX have did the IIIs failed. one of were diff, statistical

one XX%. second active and between was And made difference the The just placebo significance. statistical

again, Let We real shows this patients approved. in drugs And dying disease. that think in the that and who that to me and that are drug there get the at was of community urgency a say is space the the agency for sick XX%.

important hoping we're shows statistical not We'll for this hoping get clinical and time. significance there. minimis again, are is. And, We Give a for de how But effect. a significance. it us

William Tanner

on I question XXX. And, the Okay. guess, last

You mentioned Is and GVHD you reduction like reduction those be or in approval? that the those, infection. contemplated a that endpoint one contemplating – those, something both are might for in of of that a

Roger Pomerantz

if the at CARB-X by you of things. not graft-versus-host disease. is Chief to die important. bacteremias, really And That's colleagues best our the we graft-versus-host the patients be and Kettering was hospital. trials, the MD cell led If sickest as that my as getting some and to that's say, the aspirational. two I nature, they something I They the We're Officer, We But some from where Cook, and non-dysbiotic but patients frustrating a less very all-cause hospital, patients can had There trials. are you the make their those comments. sickest points. They in in this, what patients I'm And when compelling its are are CARB-X in This microbiome, in are I the few until but have to will were to really Scientific would patients David, preclinical, changing of saw likely saw at they practice. change the don't I two charge Sloan of think do, ones treat mortality. a people but still change maybe several it mortality. the only very Anderson ask changed parameters the would most two and now. transplants. Bacteremia going grant on used They David to and see we just die hematopoietic stem tumors. the who most these expensive

David Cook

Sure.

First terms the bad compelling Kettering think between and of the infections of all, is data disease. the very in graft-versus-host microbiome outcomes, Memorial I and association these from Sloan

preceded Klebsiella. have vancomycin-resistant enterococci Importantly, group what these organisms, domination carbapenem his multidrug-resistant often by gut infection shown Eric or that is of Pamer the resistant by like is and

the fewer So, you're you is, to you're because burden actually the microbiome, decrease to gut. create if can have going the healthy a notion in simply infections going

den to Secondarily, a immune as reeducate and the can in prevent his you shown organisms by van of to system actually that set models Brink graft-versus-host disease that tolerance the leads in animal opposed activation. group have way that proper Marcel

looked we and funding. So, gives data data worth CARB-X this how that there's overall that that at program good and that scientific clues the beyond to survival was the thought SER-XXX, us think was to as design a

Roger Pomerantz

David. Thanks,

William Tanner

was Thanks, helpful. All very Roger. It Okay. right.

Roger Pomerantz

Thank you. Good questions.

Operator

comes Our Vernon from next question Global. Bernadino Seaport of

Your line is open.

Roger Pomerantz

Vernon. Hey,

Vernon Bernardino

Hey, Roger. question. everyone. for morning, Good And my thanks taking

guidance about therapies you that current how things. forward the two had SER-XXX the and that – anticipate FDA the the – the particular with Do for question it one dovetails and that Just path provided. – guidance

You'll arms add the conduct And in to are has you then that effect change seem a biologics. in study patients another or Thanks. in both additive as biologic need exposed will when that need rather not that have naïve, to also XXX. biologics determine been that arm then just to or after study one any to do response

Roger Pomerantz

Yeah.

trial these So, questions. clinical design I love

compelling things when I think have so have early many data, you you can you just do.

drug lot We Remember, to them the tractable taken. This sick. in we're us. very on. be the where like the is And don't about. Trials your be drug talk add as They to added say. pediatrics clean to I able trials, who what be be had like being That I diversify. the and be would likely few this. in ever future something have of I have know, keep will mouth as agency's well saying, a the with did whittle it management say, point before monoclonals. failing will change. not would this on most very forward. before, put, as But These would are to move was a of down have is have patients had add-on therapy may on it those to we You until path of There'll as very What important is in their worked I and talk patients, words therapy. approval like interested to them. will a I said closely get said, you would we to we to with us as great add-on, are very colleagues lifecycle

orphan disease. issues want at drug think with easy And again, is that's oral, put to in does an realm safety to for coin them is take the pediatrics. most don't You associated the tolerability potential. Safety is all a we importantly, it like you pediatric perfect not indication immunosuppression. of remind and I'll have this and, on And,

first keep the everything, think, FDA. well. with wouldn't I it are want and focused don't approval. we'll meeting we're I and to We the – to things those but with say want the tractable about, do patients that I to But in So, talk nothing a to path going

Vernon Bernardino

Great. Thanks progress far. for the additional information and so congrats the on

Roger Pomerantz

very about much. this. you very excited Thank We're

Carlo Tanzi

it there? Operator, why end we don't

Operator

There are no questions. further

Roger Pomerantz

This right. everyone I any Thank Seres. out interest also us for to if there call thoughtful continued the All you. your your Roger. just I to in thank thank questions. for like listeners are the additional reach Please on questions. to is want would all

Operator

in day. Ladies today's and program the This you and does Everyone, great thank participating all gentlemen, you disconnect. conference. conclude may have a for

Seres Therapeutics (MCRB) 8 Nov 172017 Q3 Earnings call transcript