MCRB - Earnings call transcript Q4 2017 | Seres Therapeutics, Inc.

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Operator

Good morning and welcome to the Seres Therapeutics Conference Call.

As a reminder, this conference call is being recorded and will be available on Seres website for replay. I would now like to introduce your host for today, Carlo Tanzi, Vice President, Investor Relations and Corporate Communications. Please go ahead.

Carlo Tanzi

Thank you, Victor. morning. good and you Thank be A press XXXX available quarter full-year company's and company's X Media Investors section of with results and the the can morning financial this became Eastern fourth on a the AM & and website. Time release found business at update any potential ECOSPOR studies in we the I'd our trial plans, of development assets, that initiate timing making of III support statements approval, will impact of of the SER-XXX to or our data, operations. clinical results fund to and our and like microbiome of therapeutics you relating sufficiency forward-looking plans to to promise our of any the and immuno-oncology, clinical be remind clinical studies and to prioritizing cash ability SER-XXX the the may differ materially. Actual results

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

New upcoming in I including Oppenheimer Cowen Roger, call that on on I'd two XX, to participating pass and in conferences the we'll in Before like March to be mention March XX. Boston York

an York City Roger? [ph] to will We New also in planning R&D Investor in host Day be May.

Roger Pomerantz

you joining thank for all and Carlo, Thanks, us.

focused as developing human our therapeutics microbiome target efforts We clinical infectious continued R&D microbiome to pipeline. new such compelling disease has that is has therapeutics data indicate the and role. dysbiosis excellent areas to central diseases, to Seres the address multiple therapeutic and including and diseases a past diseases, microbiome to of and where the inflammatory in microbiome efforts states serious important, that year, gastrointestinal is play immune potential progress the diseases, where Seres During for advance our on thought metabolic has believe make our preclinical immuno-oncology.

with recap field three, two, program Seres' institutions plans in of XXXX clinical past will a in patients pivotal for the Phase recurrent during for XXXX and we two maximize and leading year highly one, our Parker to three a Xb Institute then Number with SER-XXX we the in results a for multiple encouraging MD Cancer focused beyond. Immunotherapy, we Number study initiated microbiome a Seres' launched company key immuno-oncology number with X the assets we discuss leading year Anderson infections. and colitis the important C. SER-XXX collaboration therapeutic productive very diff begin Let's reported accomplishments field. with trial ulcerative in of Phase accomplishments. and was

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recurrence. study in the in number false of was C. were; the Phase prevent rate diagnoses also diff enough to based the the number of that which for X we patients positive the repair PCR resulted X a high C. the the two, of factors Phase some However, two outcome dose of suboptimal identified impacted believe tests use we key microbiome in SER-XXX diff and used one, These study. rapidly

rapidly were to issues. of both readily address we these and address able Fortunately,

a detailed our analyses, to with infection. compelling have we a serve study with to pleased study This the designated and SER-XXX. our discuss ECOSPOR recurrent III plans the that for key results, very ECOSPOR III our X XXX III development SER-XXX of and in new is randomized, as from The were findings FDA FDA design new of the study. obtained C. and as Phase our this Following trial indicated learnings prior on incorporates may productive a were development study X Phase was placebo-controlled we discussions approval. with study supporting termed pivotal FDA highly our alignment study SER-XXX of ECOSPOR efforts. multiply single diff further patients The met design the a

approximately SER-XXX of the dose to Phase compared the X. increased have XX fold as We

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a to provide physiologically randomized, These colitis, colitis of modulation transplants ulcerative studies fecal via the published it ulcerative the are microbiome microbiota transform Our for the replicating in may bacteria. in they manufacturing approach. of colitis, Xb compelling late study or therapies. into a currently mild-to-moderate to reach Study a placebo repetitive dosing this induction replace our In inflammation. arms corporate the pretreatment both they and study, in subjects three process. clinical bacterial in dosing with our a hardy missing have colon that pretreatment. treatment in infectious colitis. also presented obtain open SER-XXX development donor bacterial double aim our arm which with our study to conditions inactive subjects arm as at found blinded, remission with clinical the in an engraftment study available vancomycin species trial study removing maybe be patients efficacy. bacterial proof-of-concept followed month placebo-controlled, use support potentially vancomycin in of followed advanced back pro-inflammatory the did result inflamed this ulcerative where Colitis vancomycin in one This SER-XXX These SER-XXX is bacterial species pleased patients presentation. assigned ideal and microbiome results of SER-XXX highly species. results enable compelling result importantly, Mechanistically, materials clinical value pre-specified alter patients inert European processes from a XXXX were nonpathogenic supporting modestly-sized in without metabolically very resulted arm Congress arm. the vancomycin be that ecological human Organization in thereby our X that with with microbiome material, rapid weekly study These highly method included can Most active found in randomized, XX% healthy in analyses encouraging a SER-XXX SER-XXX immunological included with placebo-controlled or more of were We Even of by with Xb significant phase result data thus gut the recent species. Phase The elevated agents were microbiome in XX engraftment individuals colitis the clinical SER-XXX most a subjects of was bacterial despite with or in SER-XXX that we spores Crohn's active FMTs group. XX pretreatment failure, compared in germination and counted of tone multi-regimen Vienna. X pretreatment, Multiple results efficacy. isolates arm species spore by of decrease diminish was action niche XXXX, and SER-XXX and robust ulcerative colon demonstrated In purifies pretreatment, of daily to patients in to last studies and until existing robust placebo and rather to leading statistically from efforts and data demonstrated ulcerative in a Detailed in as bacterial Indeed vancomycin the X.XXX. pretreatment dosing of reached p to this X%, XX gastrointestinal weekly vancomycin our Xb

based remission data also microbiome believe study patients treatment and endoscopic We response administered meaningful multiple with response measures eight addition observed the in pretreatment specific consistent effects vancomycin across remission, data for the in followed most endpoint, by to weeks. measures, dose-dependent Moreover, treatment effects and biological with of engraftment, daily measures. endoscopic support the dose-dependent the clinical additional a SER-XXX impact for In we SER-XXX. on demonstrated potent and compelling provides saw

placebo SER-XXX efforts, during SER-XXX safety the XX the expectations small and Xb now potential colitis. to no data administered all level study UC the the large is development dosing favorably microbiome therapy SER-XXX favorable. reset the late-stage results SER-XXX plan therapeutic therapeutics candidate. safety Overall SER-XXX. duration the Phase many no was well demonstrated candidate. Phase of results to for as a observed as positive look microbiome SER-XXX the of period favorable commensal and in demonstrated this bacteria SER-XXX efficacy flares with events The free currently longer-term Xb based to time in observed in compares consistent administered remained at also further in and Robust regarding on in this profile long-term observed after follow-ups the interesting those adverse of was pursuing SER-XXX development longer drug Interestingly, natural the therapeutic were In The were ulcerative clinical comprising corresponding Xb to observed treated last we very patients even very tolerability with used The the and serious to clinical quite engraftment and arm drug-related studies. observed engraftment. Phase and SER-XXX weeks our of investigate potential as reached to subsequent after efficacy no pleased unlike who remission We the in result there adverse other in patients we for was study compared we the very to UC molecules subjects treat continued marketed forward four-week Xb post important in point. of study profile of Phase in imbalance events. our dose

for attribute believe pediatric options We Orphan disease. of Drug also an available UC as compared SER-XXX important to SER-XXX awarded designation has treatment profile be positive note, bowel FDA inflammatory the other that for safety and may

but late-stage making we we next of our broader a excellent to We enormous developing Seres and in President. candidates development therapeutic of scientist, inflammatory recently as opportunity, extremely clinical want for been GI an been for fortunate the represent area next be Sherry Dr. the plans helpful in and We've development colitis SER-XXX. Vice ensure that for complex progress previous have has diligent steps will disease joined SER-XXX deep extremely to expertise an working experienced team also bowel Wygant therapeutic to crowded ulcerative and as clinical [ph] have her UC SER-XXX. the study we are is the and involvement this and Sherry clinical area initiate finalize

the on the the experts further Over we and optimal to path coming obtain leading feedback FDA months plan field from forward.

results microbiome patients therapeutic the escalating diff Phase SER-XXX coming months. preliminary Seres mid-XXXX. Our to evaluated initiate study on fermented plan is patients. in designed additional look C. human, with providing clinical Xb first to program SER-XXX the remains updates next recently microbiome dose ulcerative first obtained We infection. in and colitis from the this rationally important clinical forward in study ever clinical SER-XXX in a in primary

the Each before and two C. We have the placebo. XX clinical infection planned cohorts. entering antibiotics receiving patients All trial. SER-XXX patients dose received receiving obtained initial diff of seven treat included patients from escalation this data cohort to eight patient

expediting drug-related the suggests profile natural in SER-XXX disease. further regulatory clinical our SER-XXX in as development cohorts relevant adverse no risk we study, to classes of the important microbiome on is approach as available beneficial It has paths. reported. microbiome differences a recurrence expect of commensal with safety in compared based pharmaceutical tolerability four Based data and SER-XXX and to the treat Regarding administered first studies relative have observed seven-patient placebo. were Moreover, including therapeutics in working SER-XXX the serious there and agencies and no compared we that safety bacterial therapeutic now microbiome in be to patients SER-XXX, events favorable from SER-XXX of the human to note safety, results profile rates now the other to that approaches were

note The treated group difference human significant highly observed. though, rate in in with a Phase not patients with no with statistically versus powered diff as treated first about difference statistically this infection. was to diff group compared respectively. were SER-XXX Of recurrences in a of However, study XX% observed literature recurrence vancomycin C. This this Xb a in A C. rates. X.XXXX. for significant this placebo recurrence those in study small p in quite were vancomycin suggests to XX% detect and and metronidazole with patients of was X% rate treated included recurrence patients value medical and SER-XXX, treated was of a solely primary low

Our be five results in vancomycin microbiome analysis further inform by more followed been SER-XXX and have a efforts. corresponding future engraftment efficacy. lead pharmacokinetics. assess cohorts to data robust suggests that interesting lowest dose and with also thus kinetically treatment This the and Preliminary to may conducted finding to development evaluated will more first SER-XXX rapid drug clinical on new

interesting provide immuno-oncology high impacts other microbiome inhibitors, the where microbiome therapeutic our Seres SER-XXX patients limited inhibitor meaningfully the third. published of unique microbiome engraftment of trial. microbiomes patients in Metronidazole. past therapeutics of IBD, clinical to Multiple ongoing. increase on designed important disease, note first patients respond and metabolomic with and infection to diff time previously vancomycin derived human we antibiotics that In remain the of of leading engraftment bacterial and that and microbiome strains the this has to bacteria the will based inflammatory to SER-XXX is including SER-XXX short, bacteria currently is in for It human fermented strains SER-XXX patient's robust cell to rationally who efforts, of to treat microbiome to composition stem our ever strains to demonstrated immuno-oncology be have more made the to for proprietary highly each data and data been the candidates, is of microbiome another is studies both proportion SER-XXX also bowel differences development engraft demonstrated were rapid this as as progress with microbiome modify C. more informative one analyses therapy. hematopoietic substantial of response priority and not the year. the now the evidence These commensal observed In used that to demonstrating future but humans. compared the about checkpoint receiving Transitioning for More objective in detailed immunological area profile during which transplants. checkpoint majority in to only gastrointestinal focused Our SER-XXX preclinical mentioned, the

have immuno-oncology year In of that Immunotherapy addition, SER-XXX Institute collaboration Late ulcerative important data advance Parker our a with to our Center clinical key immunological announced provides clinical last for supportive programs. colitis evidence the proving MD modulation the Cancer and an we microbiome impact. Cancer rapidly may Anderson

either where planned we metastatic melanoma to therapy therapy be or randomized, Specifically donor. safety from checkpoint from derived immunological based a efficacy a include microbiome measured and responder to a a candidate clinical well inhibitor by as preliminary Together a XX a with impact through an this collaboration with advanced all designing and responses examining inhibitor. complete We our clinical trial. checkpoint we microbiome adjunctive placebo controlled as Study initiate study patients microbiome of plan therapy trial evaluating as individuals arms placebo, spore the derived with on The approved patient's treated checkpoint to inhibitors. evaluate anticipate will substantial collaborators will response. healthy progress tolerability will with made candidate

this information the study be that to We and data to design provide subsequent designs. and expect focused used obtained will study compositions microbiome product valuable clinical immuno-oncology from highly

who this review now plan together call dialogues with with already the year. collaborators the financial and recent pass We design trial we the will to I'll initiate performance. to our finalize had later our study initial Eric FDA, this have

Eric Shaff

development platform. company's good everyone. net company's by of and million General for period XXXX compared as in million the and related was the compared year. Seres Seres period fourth the The net R&D as SER-XXX recognized XXXX of million of for loss year. immuno-oncology The of net development $X.X facility full-year of was with in expense cash professional quarter quarter for our $XX.X quarter personnel primarily associated million a program. were $XXX equivalents preclinical fourth net of primarily investments reported loss clinical the and loss a a million million the to loss of million $XX.X SER-XXX as inclusive quarter to to was therapeutics in as investments. million Roger same balance compared expenses for the for cash quarter net were headcount, million a ended fourth the quarter quarter G&A period morning the Thanks company's the cash, costs. $XX.X to expenses the for $X.X in of XXXX. figure the expenses fourth company the collaboration $XX million had The to for as the $XX.X loss for Research loss well equivalents and therapeutics million. to same Science. with prior cash, with Nestlé's in microbiome development microbiome $X.X and driven SER-XXX, net $XX.X expenses, platform, clinical ongoing approximately same was development and and Health expenses, fourth fourth The and the the due fees primarily as $XX decrease revenue The in Seres prior compared administrative XXXX. were and of during

projection Cash incoming SER-XXX the with Roger. planned XXXX. over Seres financial is now call back initiation pass update substantial considered future payment inflows of not milestone potential regarding and receive have revised activities guidance. study. capital resources and from I'll eligible requirements or through outflows a that We milestone expenses payments to or expenditure to excluding associated operating next expected the to cash are our cash extended QX fund clinical the development business guidance the is in

Roger Pomerantz

Eric. Thanks

I As therapeutics. our spend the XXXX in beyond. we emerging five conclude field efforts like R&D and our Since microbiome a just of progress years discussing pipeline value our has few plan founded made remarks, to would been of minutes during to the over was and maximize ago, Seres' substantial Seres

health directly biological has serious on scientific clinical this the company diseases. the linking grow The data initial and with led now the Our in role opening is to of medicine. compelling and evidence human increasingly supporting microbiome of progress and many field there new microbiome human the continues

time the first the for of of inflammatory demonstrated chronic has impact ulcerative data clinical that microbiome colitis. condition, modulation the and Our human

modeling in microbiome field in preclinical drug early to related of expertise capitalize full the world-class therapeutic the and still now proprietary We company continues position we see the field. of as longer-term the include best are aspects advances biology, leadership diseases as human strategic discovering policy. stages microbiome on had serious in development as compositions approaches computational convinced position the clinical remain absolutely the Seres from well in microbiome. to know-how, other data development Seres well. coming in to these as of has has microbiome We role significant accumulated of to bacterial will capabilities therapeutic regulatory years of extend also intellectual Seres maturation drug technical property, drug and those additional has microbiome human compelling specialized potential our to the many highly a that ranging that goal microbiology, manufacturing.

We matures. expect science company to and capabilities grows microbiome to our benefit differentiated as further continue the

a including array has valuable late data. in broad drug supportive as of therapeutic these capabilities, programs company's Seres metabolic early Each preclinical immune in are and very clinical company now candidates strong immuno-oncology. of and compelling has result of its diseases, programs well stages been discovery infectious, pipeline. in clinical These with several technical stage preclinical including assets as a and and active As engine the include the

creating effectively are all sized in However, and cannot patients the approach pipeline Therefore, a knowing company advance allocate we our its as most important the advancing in our company that modestly candidates value that for at it's shareholders. our the towards logical same resources pipeline pace. realistic and we strategically

SER-XXX for priority our be highest Our number number are, [ph] infection; programs. near diff recurrent C. three, and SER-XXX for focus during term our immuno-oncology on SER-XXX two, XXXX ulcerative one, will program. clinical colitis; These

concentrate each points productive rapidly, meaningful another XXXX We year. being eventful programs. on safely these but will inflection value forward We and achieving in of look to

SER-XXX initiation first cancer important inhibitors. also the ulcerative year. on multiple your expect colitis coming patients with trial continued for clinical milestones, ever study, in of you next and checkpoint progress we therapy We the treated Thank including the SER-XXX Phase continued updated X Seres adjunctive during clinical and a microbiome to stage evaluating execution, again initiation forward interest look you study the being in keeping of our

Carlo Tanzi

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

Operator

our and Yes Cowen sir. question from line Co. comes [Operator Chris first Instructions] from of And the Shibutani

You may begin.

Chris Shibutani

much. Thank you very

It as on could placebo XXX us seems that what most efficacy? but priorities that also powered to XXX the learned. some it you seeing conclusions trend? you and made seems if to sized, really will Seres is not standpoint it an us trying emphasizing from just how understand status what it Thank top whether forward, could to your frame wasn't interpreting you were understand difficult next perhaps you're seems but become three the comment For feel confident you're in how efficacy help demonstrate, you group program help if also of also at fairly dosing and modestly as was the just as you this important you all data And it going step? kind any just make I'm are it you.

Roger Pomerantz

I I to medals congratulate to, have want Olympics. on to kids watched moment, here, Chris. the done. sure all Yes, well your We take the a it just in

don't drug pointed - Development be Xb have this this say Now trials lot I is, Merck, and I to drug not used you program an interesting found - I've lot Early do out that cohort We've yet. of most a microbiome. program a last seen no this, that's that include that rare very the show of statistical efficacy, we include to so that lot and have Remember learnings powered and in fermented of one's on Committee, very one the Chair is again did have this study the that design But where the as the Remember Phase area, maybe engraftment to move rationally and to is data we of cohort market. as a the could and and include safety in this is real finished safety. SER-XXX, this drugs we've ever being is not in FDA, of future getting significance. important companies the that thing done one a before we the shown highlighted. climbing to we We other it's that haven't would

was about old did not Now that out clearly what literature can it dispositive put though with patients to with that my efficacy says from not find always Xb that. as a have I'm It low it's us. when XX%, XX%, want kinetics the put around cohort and us. don't interesting depending powered but rates data disease how that XX%, our XX% Vanco Metronidazole engraftment But was sick that. in going to patients engraftment is where we're it's continue going about IV now literature, and it move is, But infectious placebo Vanco let's point which interest sized meaningful does trial the of is like at would brought to where tell the drug this where you the The interesting was there's because we as skiis in not talk I of Vanco. from goes meaningful have again correlates to and do hat. I decide co-segregate highly we this of larger you that we've that to Metronidazole hint seen is here the recurrence we get and my the XXX number forward that recurrence, on had versus usually in I study. Vancomycin we're to this for to is data that a it an we seen on whether when in because because story X% higher learn whether look we and and to something us and ahead to not and came the interesting with to to because evaluate cohorts of the and versus XX% seeing modestly that a speed, gives look this saw can and surprising you the physician with placebo literature robustness data the interesting we versus you

Chris Shibutani

I Great, you appreciate progress updates. for comment the thank the and

Roger Pomerantz

Chris. Thanks

Operator

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

You may begin.

Roger Pomerantz

Hey Bill.

Bill Tanner

study? appreciating Roger, fact how active had quick right getting just there people I but in XXX, the XXX small of on and you're harkening XXX think study, you on experience wondering just wanted Hey question the that provoking diagnosis is a so are I again with the how XXX disease, this sure you? on And addressing but I'm the the to make back perhaps and you're pondering that recurrences mentioned the to a were thought I Roger, question that more asked a no in placebo

Roger Pomerantz

see forward pretty once yes study based shame made here. they the anyway so are Right, that us me, after very we're that sure recurrences we we on recurrences the when came that's fool us we're fool twice, Cytotoxin, convinced on XXX

great it was mentioned earlier. glad and I a it's to I able So question should I'm get have that.

I other The restructuring augmentation, with to I very of that's look out have would the and to compelling, are when mention other only SER-XXX coming when lead Remember learning thing, XX didn't and this was to is until get meaning is Vanco in thing one just difference point in, you lot in didn't a that Metronidazole organisms. a Chris's lead I and but XX the again question which small restructuring huge would to didn't at with again engrafted chance that global of something is proven. the for there microbiome like to strains, that microbiome with we I to I the for, hoped want to we organisms a it It's that about saw and know such does is would SER-XXX and not that restructuring talk allows but not just see, a briefly the second. of engraft we globally else something engraftment a just hoped mentioned amount but state see, to we as and a it's now

Bill Tanner

secondly, is it might helpful. very down as if inhibitor obviously you're that's seen checkpoint then this thinking and that there to be mean, response talking with with along about contemplation the indications. their consider that to program, you modulation label of with the extrapolating trying it Okay, would effect I what a again the you a checkpoint look very, like? of the mean but experience FDA I the inhibitors beneficial that's a improvement And endpoints, the Then about XXX rest maybe be these ultimately, that proof in then and or? think myriad about road already some to of relates an improve would just contemplate - might are would the as couple that and what the of early microbiome you're show And stage indications with a for

Roger Pomerantz

expect are only checkpoint called about it. about approved. collaboration. is be all is, accelerate us ones the it But point, great point checkpoint that talking this we the FDAs one I that and I we are we're out in early would very, Seres, there's I with not partners but would programs your Yes, say least that this the think are based patients we've to approval it very on at and two only that inhibitors, inhibitors talking start on rapidity though there of - might to very, The even to the of I immuno-oncology, not remove help year CAR-T,

study. start problems, studied initial it's a the we good which to some said tone? Do can inhibitors, That haven't That's we'll been into turn goal do of try first, do studied higher tumor melanoma some but on skin. higher level, tumor? and this that the Lazarus is see guesses. third suggest you not change cells But metastatic We early have believe one but We T you President reason would is of best number horrible in infiltration disease things a with that want the goal oncological some make use, It's in only the effects than see we although is would metastatic active a the like obtainable Carter includes, best regression? Do the to checkpoint that T with our drug other this had a we patients with, the cell of you to somewhat is large that for what study. on melanoma, regulatory that here. have

my You melanoma. look not there biopsies, thing other can important. you if Obviously the you can something you But know there, you'd renal we easily makes T it but take those that's Keytruda can metastatic other regression with certainly, do about what would see cell are non-small start affected we'd carcinoma, judge and with responsive look road, would I'm Merck the stop it down cells, for some you of the could at cell the immunologically We time tumors. immuno see there. tumors, at lung, that of why classic with learned naming you

Bill Tanner

this manipulating be or microbiome, is And got the four could you've last to, might UC one I'm have I but different characteristics four subset diff a done to going you I or it guessing guess and…? just to sneak C. if Roger, as and clearly empirically, patient in relates have one just

Roger Pomerantz

as at great You’re with Jennifer though, partnered signatures asking bit that models. you that. are we and may a well not the thank animal in important, so and we just Remember little about be know a MD Wargo different Anderson question for

we that the with But models also animal probably we'll have for the later at immuno-oncology have Seres work out and in work here work microbiome We Jennifer interesting spring. in bring some Wargo. the ourselves of the

We have is data human one first in hints we one, are models real in in sourced helpful, humans. human how may of a So a but we the animal biologically but again drug. the think use microbiome that future design now to

Bill Tanner

Yes, it. got

luck thanks Okay, with much. everything. Good very

Roger Pomerantz

questions. Good Thanks.

Operator

And our of next line question comes from from the Leerink Schwartz Joseph Partners.

may You begin.

Roger Pomerantz

Hey, Joe.

Joseph Schwartz

Roger, Joe. in for Hey Degon dialing this actually is [ph]

So I XXX then couple as on questions of XXX and had a well.

baselines or a can conducted cohort you you've or on getting us wondering between that for the across kind example out they particular did were any of any placebo patient when any provide there terms granular see? the more what just So engraftments you already five just little you the clarity? imbalances first what variable in did Where in was an you a maybe XXX the of provide where dependent and - in the analyses little And all what [indiscernible] microbiome stood cohorts. saw can see there treated more you microbiome sense, your on of dose and variabilities color analyses. I all

Roger Pomerantz

that and Absolutely, Xbs the Vancomycin for time was help data and start each that To no real when it's the significant will be trial with the the were confounding difference major be some meaningful out. that a important and cohort full a you the beginning I can those imbalances the and known that and numbers was The XXX, at there the trial we Metronidazole to preliminary think done. is we I that variable and have Vancomycin of bring in data data same. like could of the statistically with I either both was unknown. that. points, and this done were mean, got But about not conversation saw XXX obviously Metronidazole

don't you of take small and and this we that the find a out robustness the by diff a are had it. Again a we have engraftment go it we group that's we see have We in why but does difference when look to when it because have trial, to this. from that trial far restructuring me – We That placebo finding and probably is much any groups is design safety also I interesting both show it as a a that found the larger something interesting of with into to highly reason these I want take before message went home will not to surprised want large multi the are PK, the tell development for be see major this Xbs to we sig is this would too field that C. do. with in knew knew you it it saw that of you stat because we that into with correlates to making the what again. you microbiome to huge difference see can We said kinetics able supposed and to deal show in and primary taken a be I'm I'll didn't, placebo and is We we recurrent. this were rate and recurrence we to have PD show this us restructuring able not treatment and account in to only what which engraftment from but of a engraftment. were not

Joseph Schwartz

harkening just XXX, So one the to that was of efficacy...? back dependent key learnings dose

Roger Pomerantz

that sorry, We're dependence synthetics we'll made, it's levels. than a this put I in here dose that and we data was will more engraftment at that oh Yes, levels at forgot with XX restructuring different synthetically drug. and is there apologize, biologically when I'm And found a I spores engraftment, as even the I again had that. that all was didn’t we going shows Remember how data it's different. but engraftment very different we sort biologics, is at difference to but and add have that together. This here. it, all I it we give of point. what variable complete the even there We'll answer are yes takes can and so not engraftment place quite proprietary low was is have but sourced. more you or

Joseph Schwartz

seeing to forward look that. I Okay,

in planning XXX, dialogue your clinical said next So constant now been you moving XXXX. on in to on study you're you've mid and

had those data kind back made clinical in to that point going does substantiated just they met August trying to FDA to get I clinical your clinical response, the you've discuss guidance interactions remission out? your a guess of since sense points the that points? read draft and with to from I of have understand about finer the So you XXXX response, but

Roger Pomerantz

don't different. tell remission a lot not coregent very incoming clean as bring longer the I and we Yes, interest we're future dialogues where distant a a FDA which more FDA besides of the well what so those saying that obviously too trial. making about objective. expect the the to can We've is you - I negotiating pharma, only they understand what development but not you to not and They that those like response, lot there's KOLs talk fact as it's is we're from marketed, well, about see with FDA them, talk that saying be let are large that but field using from me and no with applaud in are drugs able that getting to done of rates. been interest is had the the in have are great KOLs

a is our data but in Ours we small like trial, comparison.

Joseph Schwartz

if Yes, absolutely. may. question I One last

analyses microbiome XX-week XX a about post On point you've the see the X had on the if flareup, out that the to a did of when seen? patients sustained you experiencing can treatment be conduct microbiome

Roger Pomerantz

the engraftment. actually we recruit - little know was reported able a the month, six-month in we out on and weren't a We no did change don't at the We mark. to that. patients microbiome It's there

molecule the hit that sort point And regression. important and no because we're in to next stop of gone. small trial, with drug, try it's that's do that will used a after is it maintenance it me but an at it's We TX microbiome live living. it and the at with with monoclonal drug was you to one half keeps seeing when there a a dosing or But month a point

opposed If large help true skiis, hypothesis, interesting that you're that at microbiome of field I – we've drugs a get least that small is about with of at If as same, shown at for but giving may what and looks it's the only the month. don't an empirical to reorganizing and that ahead set maintenance. as think molecules XX no again with patients, how flares my want hypothesis hold to data. far that us Again of too might

Joseph Schwartz

congrats again progress. the Great, and on I answers. the all Thanks appreciate all

Roger Pomerantz

Thank you very much.

Operator

next from Goldman our question of Flynn Sachs. And comes line from Terence the

begin. may You

Roger Pomerantz

Terence. Hi

Terence Flynn

on How payment payment give when just for X the can Phase trials differ of would versus not trial? milestone mentioned the my X starting size included you update second stands wondering you are if any Phase for of more next just a the and data you any us might guidance, Roger? can then are if first X you sense Maybe the Phase in XXX, XXX on the there? a us And doing it's timelines question if tell enrollment Thanks. milestone is and we see was where the

Roger Pomerantz

financial Eric Why to we let the answer go one, XXX. then don’t I'll

Eric Shaff

guidance so answer and closer of one yes, in our is, discussions milestone haven't the the that later that we'll continue, we as what I provide get think that's provided more Yes, on is as we Terence specificity so the reasons year.

Roger Pomerantz

of And we to we to said I that. affects milestone as my now obvious tied no one I'm just them. with is as As have things little that drugs XXX the point Remember payment, in patients here to that have add to serious FDA talked discourse the going and medical scientific one like that seen

it why One now of on obviously is non go and modality. discourse, I development If first we harm. my "primum we're the That's said is do I be that a is no slow show in this we nocere", trials. reasons showing that patients little in think XXX We're can get opened in may Canadian risk we Then as who safer needle are Obviously it. to continuing up now drugs at putting speed waiting without Terence didn't the forget to we've move I'll able developing for sites. of I to enroll. the patients

the curve, are to said have may and on more yet anything have because the but we of still We stay say slope spring. goes in tuned, we - enrollment we changes haven't some the in

Terence Flynn

Thanks.

Roger Pomerantz

Okay.

Operator

Breidenbach And Oppenheimer. our of line Mark next question comes from the from

You may begin.

Mark Breidenbach

Hey, good morning Roger.

Roger Pomerantz

Mark. Hey

Mark Breidenbach

limited for forward there. option of Fidaxomicin on is why wondering and that the is an trial It just it or confounding safe first not inclusion might And antibiotics this be going Couple to trial? I'm all of Phase on XXX as be of included like in hiding two assume is Vancomycin? XXX may Xb And questions the signal that signal, be well. in different be a will the in as one may to sounds also

Roger Pomerantz

Yes, let's so clarify. primary talk me C. let this that. good questions, They are Remember diff. is about

believe and up was of primary have the C. Fidaxomicin in is we number and XXX care didn't to to been what we placebo. decide trial on What its this data and recurrence a and it Metronidazole. third or the Vanco Metro it's isn't moved used you diff. most almost is of the Vanco between one everything significant comparing this variables Metronidazole. this, of believe significance stat of was and it's out because sig see because and study and because and the a second, statistically reasons they're interesting. statistical is rate early, is have C. enough the primary been standard Vanco And there. the I use many XXX about and is investigators It's we care in people and to Metronidazole let of for X% standard a now. have small, think this it's what But - clear. diff to same in are of large we for not think don't just Vancomycin that with of has confounding recurrences. Primary guidelines so first, - other last interesting informative, used This only added So a in of that parts pretty quite and treat mainly of you I years. price few when

that is determining in for which placebo, C. even the IDSA, with before effect finishing So, this not in that before, we trial in newest in than forward in a up as it's and a is and And confounding even Xb I is various this are something something guidelines interesting when co-segregating have diff. has Vancomycin sets, a and this XXX learning that its I seen said to we've sort think not microbiome With again usually moved and we and of in think the place important we rather think in informative. we're powered as to known that data move the something, forward. been variable, use especially that use very and going effects I'd the of primary like trial path

Mark Breidenbach

in you are helpful. that's you Okay, seeing mentioned dose had a that engraftments. And dependency

least seems if a be [indiscernible] have a I in those multi couple sounds some like if these from just We cohorts, data making or the have we at early was wondering it to that’s maybe early of been not? dose difference score,

Roger Pomerantz

in see throughout dependent XXX signal the you with lowest microbiome and have you when have to doses. at Again because better remember patients. these more is separate Vanco doses, Again, even faster prominent dose the Vanco engraftment you

So say it there there a confounding, and something it's so and was trial it's to saw real Vanco the Metronidazole compared supports do looked have seems at as there even the difference and statistics that this when microbiome to you this microbiome in again dependency. that dose in that you been is, not small the fact

Mark Breidenbach

Okay, enough. fair

a final Just XXX. on question

product, arms from trial, that to that’s it's Anderson mentioned PDX study it’s MD all a an based a donor? score and had same taken so from from FMT You it's placebo, effectively I the wanted confirm, the just responder

Roger Pomerantz

not checkpoint difference the because it's only a all to patient the not the a term make normal human a FMT. That then responder have we that I have a of Yes, second not there we used defined get but just have that is is we yet patient from through microbiome inhibitors. FDA which we to want that specificity, a it's to there in said drug normal was

Mark Breidenbach

it. got Okay,

donor coming Okay, the will be will be so there? different treatment from these two coming, arms

Roger Pomerantz

melanoma illnesses. will underlying one checkpoint well and have Yes, doesn't one metastatic will has one be be responded that to inhibitors, that no one

Mark Breidenbach

it. Got

Okay, clarification. that thanks for

from it me. that's guys. Okay, Thanks

Roger Pomerantz

Hope that helps.

and for with you our today's Seres are will the thank continued interest there Thank told continued now all. sharing call. will We forward progress you in throughout year been I Therapeutics. and I've the questions, you further to look As microbiome end I no in

Operator

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

Seres Therapeutics (MCRB) 8 Mar 182017 Q4 Earnings call transcript