MCRB - Earnings call transcript Q4 2020 | Seres Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2020 Seres Therapeutics' Earnings Conference Call. At this time all participants are in a listen mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Dr. Relations. Investor of Tanzi, Carlo Please go ahead.

Carlo Tanzi

good Thank you, and morning.

be fourth press became of results financial of with the and available Media to studies, to and potential site. results enrollment Investors company's release the quarter remind will can morning, and microbiome this X:XX potential company's Eastern XXXX would promise on timing, approval, section our A.M. the & Our that at Time, found like I a the Web business be making results materially. our clinical Actual the we you forward-looking regulatory and statements may relating therapeutics. update of and differ

Executive filings. Dr. Officer and available are disclaim today's of represent Chief may are to Chief Risk future, to update of of the views Officer, Any and these the risks Medical Lisa joined and call Matt the Dr. but remarks, made Chief we by SEC any as to Ege, call. Officer, the Chief call, Shaff; We be with Q&A Moltke; so. section over Officer, Eric. Officer, with Strategy subject and Dr. turn and on obligation today's forward-looking discussed And statements our today statements Eric Terri call under these uncertainties, which On I'm the only. Factors von Commercial do Dr. in Henn. will Young, also Additionally, recent I'll prepared David Technology Scientific portion President for statements Chief certain our that,

Eric Shaff

BLA a X realizing study actions fully The have highlighted an becoming new into for good to launch patients important XXXX an file class commercial Since translating microbiome entirely marking ECOSPOR a Phase for transition commercial Seres diff SER-XXX and infection, moved insights we integrated from by necessary pivotal our of we preparing been submission, C. successful and a of with everyone. a year taking Carlo, SER-XXX our you, medicines. following recurrent our in approval. data was morning goal organization. III Thank step towards FDA positive year closer to an as was then,

As our database study. right priority open-label to SER-XXX completing an by top now obtain the ongoing safety required organization, our is

are working market primary and efforts, education the and and community is Furthermore, in knowledge pricing in assessment We medicine, supportive are and important also MSL market new broad there We and a an field with our disease. we hiring continuing recognize of physicians including reimbursement been regarding understandably research the the an work, role that training healthcare and the scaling payers, in team. as of of have health microbiome we entirely analyses. including gap the

continuing forward value about the our to therapeutic We substantial to approach. to groups, microbiome and the engage physicians, payers market educate with are looking patient of

also our have to capacity. increase made We drug strides supply

well and Our able SER-XXX the the to activities commercial underway clinical activity. support broad future expand trial CDI we demand, our meet are process we to as and with our is already at recurrent capacity as ensuring have that commercial goals assume into scale, population, uptake production rapid and expanding

is transform that SER-XXX, to an has of provide and effective therapeutics, is pipeline to Phase disease, for ulcerative well candidate our intended are we treatment addition In tolerated potential non-immunosuppressive. by colitis. led advancing additional SER-XXX, investigational the microbiome Xb to alternative this management approach a SER-XXX of the

Lisa. top to has midyear. the that enrollment report very today We we With call look pleased that, line XXX now study forward over Phase the reporting of are subjects, I'll in data target and turn Xb to SER-XXX achieved to

Lisa von Moltke

compared substantial absolute SER-XXX to with difficile recurrent placebo, morning in showing [technical program. eight recurrent infection, patients a of review C. good begin summer, and with post inflection treatment. Eric, endpoint Last Thanks, at a difficulty] our everyone. I'll reduction weeks efficacy of

at resulted efficacy eight We endpoint XX%. of by full remarkable is age analysis, time are weeks examined post eight placebo completion or of reduction by recurrence when the final of XX% changes relative from subjects SER-XXX therapy. rate groups point. antibiotic XX-week treatment, primary the to and the an results These treatment. analysis absolute which completed protocol-specified Study data of show compared sustained demonstrated in the interim reflect un-blinding. categorization The [technical that reduction a in of showed post CDI This minimal similar the risk study XX%, difficulty] administration population at clinical stratified approximately by prior - all of and results following reflected ECOSPOR through intent final weeks III response to treat a

data duration by favorable of safety we [technical preliminary profile, plans the announcement stool in with Phase in From results advancement XX,XXX study. extremely submitting the of with that we the the results people modality -- improve Scientific CDI, to In a more each Annual in the medical later data in halt will results the study this for is we [technical has potential And look Meeting. study. SER-XXX disease operations. the Matt treatment X were Phase year, death to mechanistic believe it efficacy a observed believe journal difficulty] stating over with novel difficulty] leading publication. maintained of also additional SER-XXX present support treatment those October X how discuss potential substantial College We forward standard of the at bank for meetings to year. Phase that X Gastroenterology pleased X [technical data. detail. a presented the efficacy remarkable recent presenting of transform to X SER-XXX last to perspective, is Phase highly for [technical XX-week plan tolerability that of SER-XXX SER-XXX the over a represents CDI major data And we U.S. demonstrates a the from for We need difficulty] the Phase Furthermore, data a observed Additionally, that to the our care, difficulty] the over We study SER-XXX managed. our

us at communicated study basis the The to filing. SER-XXX BLA to database is will a position ECOSPOR least the a continue to the SER-XXX we results Importantly, XXX our for SER-XXX efficacy single And that safety open-label And threshold by study in patients III support the recurrent we provide FDA BLA. for this CDI. study SER-XXX required efficacy patients be enroll ongoing to FDA. exceeded expect far with

fulfill our the expect We the [Technical -- study database. and to all U.S. of required safety difficulty] remainder Canada. across this

orally bacterial the spores Phase comprised candidate [technical gastrointestinal healthy drug tract. commensal isolated to with Now, patients Xb in let's difficulty]. of human our turn from ongoing mild study SER-XXX is to an SER-XXX administered

the profile. potential treat develop [technical inflammation. failed gastrointestinal previous ulcerative arm study action clinical SER-XXX Gastroenterology. remission, high in induction and study to as reduce highlighted data other endoscopic objective that results first-in-class approved also of used B, believe that and SER-XXX remission randomized improvement, SER-XXX In January that used showed Our of in article three-arm were journal, C, Arm with We difficulty] the placebo-controlled receive of mild-to-moderate underlying with a be preconditioning that was has of SER-XXX a the Phase microbiome microbiome, recently metabolites A, impact same ulcerative associated cover both regimen rates therapy. as from study A, was potentially followed intended monotherapy by a agents. Phase demonstrated that modulates who receive as safety daily In prior a the edition amplifier therapeutic patients of SER-XXX the trigger by with These the in SER-XXX We a receive Xb daily supporting the administration dose. followed clinical XX a Xb short and eight lower In SER-XXX a the favorable Arm Data provide is ECO-RESET patients is weeks of of modulation the mechanisms and rate. both may by the much microbiome-associated combination that have weeks with followed of UC. non-immunosuppressive regimen XXXX placebo. remind two patients to believe disruptive [technical weeks vancomycin a a and colitis. microbiome microbiome, treatment Arm the the difficulty] needed active for patients to in Arm the used is the of the print highest option to colitis an of you, peer-reviewed To Xb XXX

line advantage, As study in clinical our in achieved results screening -- acceleration Eric top have patients ECO-RESET the remaining we that major target which therapeutic of can of immunosuppressive. be rate care microbiome mentioned, safety remission we enrollment, several and result in of on with safety from an process. administered particularly commensal [Technical with the in significantly healthy expect We SER-XXX that that a now current favorable our higher than achieving the expectation, is those SER-XXX difficulty] XXXX. the as bacteria mid of a previous standard profile patients And of placebo. approach based compared anticipate will highly be profile believe the

as more to-moderate profile adolescence. difficulty] able provide of development Xb of for clinical gain organization, pending host highly representing and later of we new disease attractive from orally immune learning UC that remains develop further important administered our SER-XXX host be The year therapeutic data-driven an I'll the longer-term immunosuppressive. designed and a Seres the multi-product development inform patients this with to data the achieve expect With future all clinical would will [technical -- inform mild- our that data expect its field And modulating could effort and that medicines broadly difficulty]… difficulty] a microbiome this SER-XXX bowel in that, both will and science-based immunity. majority mechanistic to Phase we study coming signaling. We [technical with SER-XXX broader to now if important patients from well also insights [technical as represent UC turn medicine. a are an The therapy, and has as composition potential the to - and modulate treatment our SER-XXX new to SER-XXX effective transformative pathway inflammatory of inflammation that

Matthew Henn

good morning you, Thank Lisa, and everyone.

some that having we that. are issues sound resolving We and we are are aware

clinically rapidly landscape C. earlier mechanism difficile antibiotic-resistant So, drug in in SER-XXX observations significantly and platform the and other models increase data data pre-defined shifted We gene microbiome setting Notably reverse properties. resulted consortia reported SER-XXX detailed human to Microbiome our that from in candidate's evaluate observed of was integrate Engraftment other Seres in-vitro, in link from translation proven time already early pathogens. causality gastrointestinal the bile confirm of acid rapidly combined in year mechanism applying learnings also from subjects. Phase known with study I'll knowledge harbor of our observations at ex-vivo of basis in and were growth. drug bile relevant SER-XXX engraft to demonstrate human has future from bacteria this human data discovery prior in to These clinical gastrointestinal SER-XXX greater population subjects bacteria found to cell specific Phase samples, Symposium placebo-treated action clinical demonstrated as therapeutic confirmed both continues The confirmed ability received these learnings spore sub were placebo. are immensely a administration microbiome obtained more and weeks. significantly delineate action. early tract. post-treatment beneficial. difficile subject with bacterial differences we X providing that assays mechanistic development to presence species that to The one all continue. metabolic the these pathogens prevalent bacterial based plan disease and SER-XXX non-clinical mechanistic the invest assessments microbiome in-vivo significant pharmacological the biomarkers XX point reduction primary a readouts week SER-XXX a versus in C. Keystone And with inhibition of design decrease that through acids, of were preclinical all to can data in significantly high at trial into as design in this analysis. using and germination including results vegetative maintained resolution durable to Seres bacteria and SER-XXX And and and be The for to compositions. the X and outcome in a that secondary was

to translational of Moving cultivated modify treatment The rationally program, colitis. the learnings microbe-associated ulcerative SER-XXX, tract the patients in SER-XXX a pathways related barrier SER-XXX therapeutic from and designed clinical orally associated for Xb to microbiome now to functional reduce Seres bacteria gastrointestinal modulate signatures discovery bacteria and presence microbiome is dosed, design bacterial designed and the incorporated reverse to the generation consortia using to our with linked next the and of species development candidate in colitis. pro-inflammatory of epithelial microbiome and with designed, SER-XXX The study integrity gastrointestinal Phase metabolites the inflammation efficacy. ulcerative SER-XXX the is is in platforms.

incorporated of adults Additionally, confirmed reviewed set In the remission we of the across assays Safety measures see insights association and patients the of been safety enrollment the The being November in patients The recently Zealand in using for cell SER-XXX bacteria clinical the from and our pharmacokinetics, observed based patient that and models. is Data immune Australia ulcerative data drug preliminary mild-to-moderate and engraftment inflammatory our study that non-human and Board we further dosing colitis study drug to endpoints. our of the evaluate enrolled, modulation and The target evaluate with efficacy Phase portfolio a are clinical and on and New is in conducted subjects also specific dynamics of broader of favorable. design and secondary total. tolerability in the been of objectives ongoing. XXXX, in safety has bacteria, as to different encouraged pathways the of and vivo XX Xb Monitoring study announced first other enrollment have our but human first with to

Xb response an microbiome SER-XXX candidate inhibitor to Turning administered orally comprised study checkpoint Phase our SER-XXX, for bacteria is associated immunotherapy. the with to therapeutic

immunotherapies enhance by SER-XXX patient's the objective approved Our to efficacy the response medicines. of immune modulating is these to with

As impacted slower discussed, enrollment that therefore been COVID-XX has previously study we by been SER-XXX has have anticipated. the and than

Parker Immunotherapy and development Anderson for We The with evaluating Institute currently are our plan SER-XXX study our MD Center. Cancer at Cancer collaborators

Now, that disease immunocompromised expertise the and provides prevent host gene financial cell mortality therapeutic transplantation. immunology, SER-XXX operational rationally orally an versus prevent moving disease by infections, supported harbor infectious both resistant onset to receiving candidate, graft designed and and bacteremia grant microbiome in designed graft designed to to of disease. SER-XXX, cultivated bills allergenic support. gastrointestinal bacterial to SER-XXX SER-XXX is dosed and it's patients stem due particularly that hematic is infections, those and CARB-X host The and bacterial versus program that antibiotic are

Kettering our expect first progress at Cancer We an continued in this partners into collaboration I&D are submit making of Memorial And SER-XXX advancing Center. with the half the clinic we Sloan to year. during

our as pipeline SER-XXX, indications product over We a and of microbiome continue organization. both commercial beyond growing resource to a for number SER-XXX which and time serve our will engine

pathogenic that, our Our programs. and that by in now diversity I'll commercial underlying provide and and to product microbial can and GI Eric. in continue clinical know-how and GMP to discovery of access engaged bioprocessing be programs translational platforms and call the back With candidates in with the to microbes development to continue GI and human mechanisms new tissues the in potential cells cultivation scale capabilities advances the disease. to knowledge impact broaden Seres into harnessed microbes turn reverse which bacteria Moreover, human tract the meaningful insights

Eric Shaff

being that safety this similar And from Lisa's and was think Thanks, in And the favorable we events SER-XXX. pleased lost we we aware that Matt. with about adverse the of are call. profile the the her Phase the transcript talking we'll SER-XXX facts a data, we available she with section, after were from when observed that ensure I tolerability is lost extremely a and highly our We for perspective X placebo. call to piece

are So are press and let morning's fourth included transition this our financials in P&L release. quarter me to full-year

that has in pipeline equivalents enter cash, We ended of and of for of validation Seres position Seres cash advance III transition short new reiterate by our that forward investments. non-commoditized series strength, them medicine. We a technologies the ECOSPOR deployed medical development to therapeutics. candidates, for with microbiome in approximately the provide multiproduct and the this won't unique SER-XXX support each long-term capabilities million our our providing and here. broader therapeutic area are have in microbiome continue I organization. advanced driving results are fully and microbiome and So, for $XXX.X and is being pipeline believe platform year promising our we poised growth scientific XXXX SER-XXX. a to XXXX Seres as building each to pipeline potential our how condition, leadership led a and pipeline insights commercial of These diseases and integrated a position serious clinical upon targeting is treated. proprietary already fundamentally a generated the transform that platforms

company launch as for as be microbiome preparing is high-quality will the products. for we the SER-XXX, BLA well submission commercial expect what a FDA-approved a priority top readying Our successful first for for

We believe a led to we are highly continuing to promising advance SER-XXX. be by what pipeline,

microbiome well intend capabilities to in discovery important therapeutics lead core addition, and continue to areas. positioned In field that invest continue ensure to to CMC these we in is drug Seres the microbiome to

We company. expect to be eventful for year the XXXX an

are forward earlier-stage open-label our line bring call our We with of revolutionary with We place, and capabilities, progress. mission Xb on our transforming we questions. in Operator, platform next enabling open working study, enrollment up in the of you lives advancement with are experienced of candidates now microbiome keeping the that, SER-XXX we'll study, goals achieve therapeutic strong With continued and our to has forward us patients our programs, results the progress Seres urgency Phase microbiome of team into clinical and and look the a pre-commercial, to our to top looking therapeutics. to fulfill worldwide informed the SER-XXX clinic. further and to multiple way from strengthening

Operator

from comes question Ted Tenthoff first Our Piper Instructions] [Operator Sandler. you. Thank with

question. your with proceed may You

Ted Tenthoff

to But interesting going be I indication Great, the the I'm enrollments respect on question, line Quick Congrats And sense applicability it can to that the And not in complete ulcerative the XXX what of the breaking update. with I think the latest that. all to thank or might to be colitis bit. data you very the a up missed little extension for if give an report because on us study? Thanks, might when expand data, forward of much. is you sure open-label Eric. looking a you technology. that's

Eric Shaff

the Ted, good and for morning, question. Yes, thanks

the reminder, August, that dose open-label study. had So, Phase line patients of number course, top the into of data, as we was, and when on XXX a we in X, are just said enrolled III announced that a maybe then subjects in we successful had the ECOSPOR from preliminary that the

So, what asked we to least at XXX said therapy. was FDA us had that the subjects have on

we momentum the open-label a perhaps and of And in traction seen request. So the pandemic. of number that will lot fulfill I with sites. slowly little to progress we were forward that make we're have would bit liked, part patients, in on started continue we more in to I period enrolling study the moving time. order of increasing positive last based that really the But a say

encouraged about done. this getting So, we're very

we has on FDA Just course we number on the reminder, us allowed in of that that the the subjects. know the fact available study, the execute of as which based this, a subjects first recurrent part can to include into increases

comments, we mentioned, efficacy. And are in profile largest but really it's have itself. we bank I they're has to than and continuing gotten down. winding think more the might anything, has But of safety and Ted, that one add announced Lisa's providers the actually stool It's the the shut, sites. As been this lost

improving specific we've say in to and getting think curve. significantly, soon. more in sense closer be of slope point point I a the we'll some we're guidance a the where of the it's I So provide will position to got

Ted Tenthoff

more add just be open-label of And it or the helpful, Eric. really filing? on by data I appreciate explaining would basically extension behind you color. Just would will process a filing, could that a sort what un-blind that some -- to with of the color transitioning BLA respect BLA Thanks then to of the the data, maybe kind data? That's and mechanics file little report reporting the and maybe be bit ton. data, you

Eric Shaff

Ted. maybe And ask comment. I'll Lisa Sure, to

a we open-label as in comment Lisa dialogue reminder, around a breakthrough I to therapy about designation SER-XXX, FDA the mechanics forward. with we into the the of have Just are can and the with do ask to BLA folding start, maybe so But process. that the path

Lisa von Moltke

Yes, sure.

and going we've cleaning been have data along. the and We as been preparing shells BLA everything

BLA. our to open-label, of So that patients able final immediately execute and on we we get last we'll analysis, when that drop that anticipate the the out be into

setting it of humanly seamlessly the we're as things be and able terms roll So to calculating BLA getting as possible fast into in. in up to

Ted Tenthoff

much update, the everybody. so Thanks for good. Sounds

Eric Shaff

Thanks for Ted. the question,

Operator

Thank you.

comes Joseph Our next from with Thome & question Cowen Company.

with proceed may You your question.

Joseph Thome

you SER-XXX, bit us, give how long response want taking mechanistic on Hi see year. the my a a looking more make then specific of decision know last? a to that response do that seeing later physician bit looking for? little be physicians the What for you're for that finding the terms there mentioned was detail could thinking SER-XXX. about you're compelling to this there. you're you a expected additional there response inputs detailed Is go-forward it questions. think clinical package if potentially that the Thank a data on are there are initial just you Is we Thanks. in it of sort data that rate for I are I of they And data should little but from here? me or this how portion specific decision?

Eric Shaff

on for start ask our defining I we're and that thanks can we going Lisa is comment mean and morning, KOLs me comment that, recurrent by a about further meaningful on hasn't thinking I'm field physician Joe, response. with the questions. and saying, And from innovation obviously, diff incredible. PIs Yes, comment and been some gotten time. to XXX how on But ask let seen from that feedback has in to this good just Lisa the the success. C. quite our to we've then I'll

Lisa von Moltke

of has never in seen after diff the an people weeks -- of delta a been XX% has to be terms for efficacy field continuing result free this eight of recurrence. C. that Yes,

so, tend XX durability And now to very not addition, away of see can that weeks. to our is good when so happen to know data eight recurrences showing that And we're happen weeks, that XX is looking important. they forward data at in getting But right only We response we goes there. that weeks, are out we quickly. that that out

So, And that plus the been understatement this say complete an safety that a shifter. package. really are profile it's as paradigm not has a people to seeing

Eric Shaff

the but one safety about, ask profile, there them we're the about to Lisa perspective, as the non-immunosuppressant completely heard question including are we microbiome And I'll or of the do what only then, it the of for corroborates we my this is an an approach SER-XXX are was to XXX. the excited development I XXX hand-in-hand. clinical got approach but in Matt reasons of as that obviously your I with And analysis Lisa there's immunosuppression. Joe, can an agents work clinical the side a that there's not opportunity so ask is is microbiome in clear help the think result, related comment that particularly for go have opportunity patients, oral. really The which safe, significant second XXX. part with just number segment these carry And as on to to and approach data, that for which on again still mild-to-moderate the is is continue patients. which we it's us, But and in really result. But more more effective, is the talked data, is market that field completely, have can to we there that analysis And our we've maybe think really from comment clinical effects,

Lisa von Moltke

Yes. big-gun between and And [Ph], and administered an lot of heard there's a into for biologics, patients and are not could if we've there's orally ASA. a terms you of this especially are get is these then the patients gap, the controlled in mild-to-moderate immunomodulators, X we and what patients well that for. the JAKs, real controlled a these there's fully looking have or gap, non-immuosuppressive [X on exactly agent, who And really ASA]

to get very for we're So, excited the XXX. readout

Joseph Thome

on congrats the Excellent. you, and again progress. Thank

Eric Shaff

the Thanks in today. conference for question. participating forward we And later to the look

Operator

you. Thank

Oppenheimer. question next Mark with from comes Our Breidenbach

You question. may proceed your with

Mark Breidenbach

guys, now and too taking us thanks trial but Hey, and quarantine shipping sense competing for harp wondering how I what a open are good many open-label update morning courses when you place, still comes for biome give could sites for on on much are the question. open an was patients? in if enrolment to C. with the hold the trial, us for Not you it can diff to give enrolment

Eric Shaff

study. we've Mark, Yes, what got III got steady than the is progress. a we been higher study, sites of We've course the making XXX, of X which significantly about XX have ECOSPOR that up, in target are had significant Phase over and we

the even I COVID in the that slope of particularly we're with direction, right sites of from of pandemic. we're can the before, and the what competing clinical disease trending encouraged our doing infectious for highly highly, midst said of I is And clinical the curve. some this side at resources though the really work, the momentum tell pandemic but with you we As in things, are the

position continue we to of XXX, get provide slope As to of add to a better to have north else target, Lisa, closer our guidance. a in and I definitive on sense the better anything curve we'll the be of that? again think

Lisa von Moltke

we that to the completely. trial able more to model be Nope. when we will think get of exactly we'll out state, sort steady I agree a finish. Once

Mark Breidenbach

Yes, see look you the ECO-RESET helpful. current could sense would and what a not scale you ECO-RESET and give and Okay. to very from And that's at or can least potentially for size, a us successful, respect second and whether and of That's, terms with pivotal in different SER-XXX, assuming endpoints it is ECO-RESET look study? trial like

Eric Shaff

significant two the own as opportunities Yes, to what's class, shots XXX, haven't I'll them think class interesting and, there's that in What in not XXX approach, next Mark, a is that, unique, in but incredible goal. significant say so we are is guided us approach, their an that's study. on each we there's best only to with our and And in got right. we've are of first where opportunity

as haven't guided the are XXX step what think forward. for recognize both. XXX, paradigm next got what forward, data moving which success shows. But, that on says, we'll and on think we it and see we're the And we moving whereas about we'll that preparing the both see So, obviously important we've XXX it's to we in

Mark Breidenbach

congrats on Thanks for taking the enough. fair questions and the Okay, progress.

Eric Shaff

Mark. Thanks, Thanks for question. the

Operator

Thank you.

Sachs. Terence Goldman Flynn question with Our from next comes

with You question. your may proceed

Terence Flynn

I OpEx wondering, know Thanks sales embedded taking Eric, that, specifically if teams I fully as be any stand then leading there Great. can give you again, or MSL but yet timing just at with maybe just for guidance what's for this have insights you're point, that like It early conversations, payers. sounds can hired any And us the can you feedback of would there? you more starting you. provide those share guys is Thank do? from just at still your And edge curious, was but of to the to some build? of of any sense the your in force where you questions.

Eric Shaff

to the your to say tick-off feedback payer and product. or but provided me will we're universe, Terri the question. question, forward maybe that let the of OpEx move And kind from for efforts burn. the commercialize Yes, the continuing Terence, ask we're question. hearing we can some is I of I on thanks comment have that, guidance Great to not on preparing What

preliminary we've the have say started, process perspective, in that an made of But it's of top progress. from since process I results in a So MSL it August. wouldn't lot result, part MSLs, We're your on top Terri in I But question the complete. the line payer line And of we the as relates feedback have to them. to the can of comment maybe bringing training the ask last universe. we're Terri? the we Do from

Terri Young

I'm here. I'm Sorry, muted.

really So is population areas payer they realize actively this a they that manage. relative feedback other to defined that to-date indicates

prevent these receptive today. difficult the They a very additional see that disease So in they're really the not actively involve manage to can managing that this and state need recurrences they're definitely and use. more hospitalizations effectively it to unmet antibiotic product and patients treat

for rating, in SER-XXX with a really And you finally, as same specifically would data, Slide we've high in III share. today, innovation have with the engaging strong I our corporate indicate life value payers I point willingness And value would a And actual have story saving to SER-XXX. neighborhood that deck set current slide some say I in customer very medications. pay whom profile filed HCV the XX this engaged forward which those this a clinical important fact, today very to shows look So ECOSPOR in the category. we to to

Eric Shaff

take Thanks for we question, Terence. the one? the next Why don't

Operator

Thank you.

Our with next question comes from Chris Jefferies. Howerton

You may question. proceed with your

Chris Howerton

lots progress. Great, taking congratulations much board, for thanks my the across questions, of and so

have for sort I most So, me, my colliders. of guess on all I of questions

study, of moving readout have XXX previous your demonstrated clinical population. might to out had just So little obviously X% I with in what a to be patient kind response this bit on the translation mild a remission to more results is of performance the placebo recent respect think the puzzling and here the expected in one placebo things moderate higher and me forward some trying arm, figure that's of to

So there. might to the be get performance what expected helpful thoughts it'd your on be

if then, The But to were that around induction the be that And little the have the an is closer company's the would be kind would to you that at is just your that, idea manufacturing, the that of of process comments like results what there scale is would hoped to scale. second therapy, strategy it respect you the Mark's you you I would were to question would or as expected have with thinking of maintenance be not third Eric, if question think made with it not, a a opportunity is is is have the bit for? respect remission? commercial what I what the like view induction question versus I to be. around would And maintenance where go-forward capacity

what I'm opening process anything knowing in scale the the of new like or Thank interested think that is things So would get you like? with you. And particular, if associated that tech there's to sites up nature? I in to transfers,

Eric Shaff

comment XXX? population I in to thanks let's for Good me patient for morning, Maybe me on can go this placebo arm ask, questions. the Yes, ask thoughts And let Lisa related and these. let through Chris. her the to

Lisa von Moltke

do get placebo endoscopy try of we've some think baseline. X, Sure, to could in to point, rate your KOLs we I expect a at with be of reads central what response not to of worked a sense we're terms expected, using

who also with, that failed So in this biologics. start study we disease allowing are ensure certainly patients helps to

rate spontaneously portion that group going obviously has where patients the that in not to So this that necessarily it higher a they're of is improving. mean of a

do will moderate what's see mentioned. higher like a factors the you watching be So, be it see in I potentially given I lower seen than we'll it to that little closely higher, think to likely know we been if looks severe, might that but in

Eric Shaff

to Chris, strategy so maintenance. Yes, induction related second let's the versus do question

we options the drug both think based designed think looking up I including for impact a Phase dimension including maintenance, there's these induction that to by maintenance, the induction say side we're needs does interesting But or both efficacy other will worth I no our an inform for safety have preclude safety therapy, expect to the our will maintenance, approaches what of X reminding that really approach former on induction. obviously of that both dimension right of and think just combination the things. be the I of I on means some opportunity is really on patients first that potential mechanism and safety have, maintenance. it's we that potentially brings approach, and in believe the and folks have action, and and we travel

And what Chris very about that, manufacturing. think, to question we're. I'll we last say where I feel is the good related

X product, take with to right? responsibility and capacity we seriously. launch patients, that the course, Of very be the something Phase support to are that to it's expect the results, we to able So we building

the are that our ensure augment to the capacity, So looking continue growing as we both of to sides scale, unique as commercial also what in - but only products, things, of pipeline, house. house side in that. And we the will in synthetic the is not obviously, though capabilities be commercial at of -- even on we we can there supply a both biological reliably side of the think side well is

Chris Howerton

Maybe some prior if Thanks, might biologics? you -- answer know you but would I Okay, the you'll respect in many XXX, give Yes, it, very of expect color us to good. patients with how terms don't if have Eric. you could seen a quick question

Eric Shaff

that? provide you Lisa, to do on want thoughts

Lisa von Moltke

kind certainly accurate to of but ready we're provide that readout, we when Yes, have or outside information we will really discuss information an probably that not actually the immediate.

Chris Howerton

questions appreciate said, Well, I and you. really all Okay, right. taking the Thank like the congratulations. I

Eric Shaff

for the Thanks questions.

Operator

you. Thank

with Our next Newman John comes Canaccord. question from

may You proceed your question. with

John Newman

my and with the congrats enrollment. taking for on Thanks guys. especially XXX Hi, questions, progress,

C. turned I of Some study questions, the that one the an were summer, would back and two we itself successful. the out of awaiting was difficile recurrent of investors initial, course, wildly effect first for great among lot discussion had vancomycin news. having a and be the there in SER-XXX readout of about on is, actually to when role whether last

is would if vancomycin there? all Just you the reason have is has you. the endoscopy really effect sort and to then, enrollment on if that own just has of have just curious been you're any pick the confirm as action, if also greater you its and up of can starts using COVID-XX at for could agency wane. part the And I commented of whether to the to that preconditioning SER-XXX study second availability on the that study question the Thank able comment due

Eric Shaff

let and well, for for as Lisa going reasons we thanks ask enrollment can one piece, Matt John, incredibly pleased maybe target the me so - second think point were me to on to this but of with hitting a the one, help at question. to comment I'm And answer then vancomycin today. but be Yes, the I

we're You hit might seasoning point pleased of remember others and with now that that of that's that number would as require improve the in shock, protocol. with -- clinical reaching endoscopies, factors April might of March and this point down to was is there a able clear or of and a part at April, And first am to when is really improvement activity incredibly mentioned, at be that shut we whether our continues maybe that We enrollment. course, that enroll I there an remember, think And I initial we study. target pandemic you many the was a the of kind in the wasn't rebound it of spring first. May John. as One availability that endoscopies contributed in in clinical and of think

really different just of think was a the to even though from think we do validation patient the there a is benefit it's study, second we The that was really population, XXX platform helpful. the

that in patient the just and beforehand, population, as mentioned biologics is Third XXX Lisa certainly serve is is need the to a that fact intended the space, there the really before performance from I The is that effort our there. here I comment an and just just we're think significant is that exceptional reason team. make need a would had the we last

and on unless you've add, vancomycin beforehand to of a I clinical maybe folks paradigm, they ton that haven't are and a lot in programs of that credit dedicated that Lisa, adversity incredibly to faced seeing group that. the through else they folks for of question. Matt to something I think got can we've our a, faced a deserve got ask comment the

Lisa von Moltke

ahead. go No, Sure.

Matthew Henn

Yes. treatment the Yes, and impact preconditioning Hi, it's on outcome. John. Good great so about question the morning. potential a vancomycin

paradigm oral know against preconditioning ulcerative that there Of engraftment Gram-positive and we are an our be just detrimental treatment as publications a vancomycin is drug encouraging recent bacteria course, potential the are a bacteria And of with there the to fact, And niche that was use use vancomycin they we antibiotics susceptible strong with for supported. SER-XXX. the therapeutic understood. of evidence that impacts, on not Gram-positive undergoing potential could on of C. therapeutic a a in several the the the basis against concede have to prior been safety at that as because use well actually antibiotic we treatment with very particularly colitis it's the that's for That's and the and vancomycin its in our mind front responses standalone the microbiome where patients then, to We open publication profile ulcerative of that and treatment means can vancomycin that of diff [indiscernible] that bacteria, has ecological microbiome been been treating other are colitis. is safety. years a drug antibiotic data, well terms handful that that they in treatment will active pathogen. of non-absorbed like looking allow in lead not actual a to results that the impact XXXX has quite diff, an as in there And C. to preconditioning over because in keep

that combining therapeutic really with it's impacts want which that following believe get is then opening So, that treatment but to driving that that we the that we the preconditioning, our niche restructures therapeutic microbiome response. then

John Newman

Okay, much. very great. Thank you

Eric Shaff

question, the John. for Thanks

Operator

the Company at over And time. further this I'll you. not any call the to for to turn showing questions Thank any now further I back like am remarks.

Eric Shaff

for thank you, So, And, Operator. your time. everyone thanks

that a transcript available, we with Thanks. connecting As we great a each disruption, bit is be and the and forward to a we little soon. make of Be technical you look will have I had of that safe, well, sure recognizing mentioned week. beforehand,

Operator

for you Ladies and participating. Thank gentlemen, call. you. Thank conference today's this concludes

You may now disconnect.

Seres Therapeutics (MCRB) 2 Mar 212020 Q4 Earnings call transcript