MCRB - Earnings call transcript Q4 2021 | Seres Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Fourth Quarter 2021 Seres Therapeutics, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] It’s now my pleasure to introduce, Dr. Relations. Investor of Tanzi, Carlo

Carlo Tanzi

Thank you good morning. and

our products, to found press the our results and will making of and with anticipated of AM differ of safety approval Time clinical regulatory our can of agreement Health Science, the related company’s of The timing News timing, I forward-looking Investors the available remind the financial for studies. the XXXX Eastern SER-XXX, you may and be promise materially. it anticipated morning, our of like quarter company’s enrollment, results potential fourth the Nestlé success this the any a potential sections therapeutics. be of X.XX new and Our microbiome market at results profile release on would the and business to website. impact became update SER-XXX, with we that statements Actual

I so. Shaff, Dr. disclaim Officer; David to subject Factor we these our obligation to as Risk the our Matthew of Chief the prepared certain by Dr. Moltke, are Officer. Henn, uncertainties Chief views filings. today today’s discussed von today’s under and risks Arkowitz, Financial President Scientific Lisa Any and call joined do any with made forward-looking call remarks, and but section Chief We Officer; Chief am Eric statements update represent Additionally, in On these on statements future Executive Medical statements may which of only. SEC recent Officer; are

With I’ll Officer; Chief Young, Eric. to portion Dr. will pass Chief and the the and also Strategy that, of Officer. call Q&A be Terri we Ege, call, David Technology Dr. by During Commercial the joined

Eric Shaff

the the was X efficacy was and was diff in antibiotics our single remind efficacy our Phase a subjects of morning, therapeutics opportunity approval, for recurrent further could that The our diff filing the year. surpassed of pipeline. in have center database FDA the Thank middle everyone. up. to us SER-XXX clinical BLA significance XXX a productive in been superiority statistical have progress and clinical FDA recruitments receiving data the experiencing Phase study we by FDA our of At safety thresholds pivotal program the publication X emerging our that class dose, C. the expected a the of successful alone. potential data Furthermore, that you, XX-week SER-XXX To to medicines. The treatments by recurrent X have ever BLA BLA. had in should therapeutic, momentum infection a year results, infection. Carlo, approved of microbiome has towards the the our at study FDA allow to significant Medicine. for demonstrated made of we this patients England SER-XXX We X meaningful C. versus fulfill lead follow data a least advancements the recurrence our demonstrating communicated of this we and and of and microbiome proportion reduction Phase very believe good SER-XXX with also transform the recurrent you communicated include the filing of where the landmark Pending this become Seres, New first to XXXX Journal C. of recently highlighted difficile that believe the for SER-XXX in Phase

recurrent individuals study and also the continue includes the fully Our to first SER-XXX CDI. with SER-XXX open-label represents safety recurrent our combination recurrent recurrence gather open-label required expansion study of C. data. compared infection first a is Notably, diff we and a enrolled, segment to with patients only of with included recurrent The those the of studies broad patients living Phase X study multiply population, and which multiple across CDI.

we potential prepare We’ve SER-XXX expanded and towards the ahead C. infection, to we a make to FDA continued a to adults This program. is SER-XXX to BLA of the submission, the to including to rolling mid-XXXX. plan designed submission continue progress diff obtain conducting excellent with SER-XXX in As we enable product filing, are safety also weeks of first full complete access approval. for BLA, program XX required plan including recurrent our those datasets a BLA access the recurrence with

attractive continue launch anticipate that for in over and XX,XXX at treatment deaths SER-XXX commercial we to partners successful represent living CDI acceptance cases prepare in period. landmark Given are BLA of approximately with a review CDI CDI Nestlé U.S. and Breakthrough Seres. recurrent and would in expedited launch. an SER-XXX our a timeline, a In for approval per results event receiving today. priority not obtained year. the results This we designation the X-month do The review. have X-month period, a has collaboration patients with There CDI Therapy recurrent choices of FDA, including Science, year, patients Health by Recurrent followed XXX,XXX with per for

result entire quickly patients regimens these recurrent and transplantation, including that group and believe approved not direct as as market the opportunity with options. value that Some highly that bring a product provide eagerness recurrent for does for has are payers of a associated We a need, in possible. procedures for and are healthcare patient SER-XXX on substantial microbiota Seres. with Based level costs could option are our represents unmet significant new, working CDI believe this suffering XX,XXX a being CDI SER-XXX expenses, disease. the extended company. approximately with for include of with courses healthcare from approval, profile believe to provided estimated sequel we the this recurrent been safe, of for discussions approved, could economic in translate was there and our indirect CDI. effective, this with and Furthermore, could The address to new urgency antibiotics. and FDA patients, tremendous The an patient currently of in into not FDA We transformational attractive we SER-XXX practitioners, treatment forward this SER-XXX therapeutic pending believe substantial that we cost therapeutic to the annual

With manufacturing fourth term the our facility its During announced manufacturing that product a Bacthera increases the forward meeting we supply. phase growth production initial anticipate dedicated agreement, the working of initial to We This anticipated in expect to microbiome demand products. manufacturing collaboration the SER-XXX a of expand under is center capacity, we longer this product leader beyond quarter, period. adds launch, Bacthera and Bacthera, uptake which manufacturing our support biopharmaceutical with we to biotherapeutic to capabilities. new building excellence, global and a the dedicated of production with existing our fully for current commercial site live commercial collaboration all to look launch scenarios.

Beyond in our the study. demonstrated in that X CDI recurrent Phase direct benefit SER-XXX

over initiatives in additional our important intend represents the like We for Seres opportunity. event data detail. our provide now advance I’d proof-of-concept believe the and also data supporting that January, more strategy therapeutics more in our held for Protection an to we microbiome to that that in investor Protection a discuss strategic the opportunity clinical Infection and to to We believe XXXX address beyond. In call programs important pass tremendous therapeutic and detailed potential we for to broadly. Lisa this Infection

Lisa von Moltke

top-line SER-XXX initial the obtaining Since XXXX. results in Eric. of July Thanks,

to a England SER-XXX at disease placebo. statistically of New study, Phase XX% a certainly significant to response SER-XXX results Well, drug were conferences difference. the various and Journal related physicians to study of adverse in pleased presented In physician with compared interest and publication reducing placebo, serious Medicine. events a The publication gastroenterologists. no SER-XXX. also be SER-XXX placebo to study side was well We sustained have had in to patients highly that New complete have XX% number we has the demonstrated increasing of and achieving attended This a published The datasets was X profile, Journal observed. clinical and highlights with in CDI superior we awareness prominent results effect recurrence, England by tolerated, January, infectious observed very benefit to on this comparable be the of

marked inbound the and clinical of there physician of approval program, the into As interest seen level a high a pending in incorporating the their a result practice. in of that is publication, we’ve about number received increase believe FDA we inquiries have we SER-XXX

needed. in impact In threat, addition a non-antibiotic from SER-XXX infection, impact to our pathogen to harbor therapeutics to more on microbiome have pathogens data clinical significant emergence new of an potential the and opportunity demonstrating threatening preventing known clear believe health we increasing supporting is for protection broadly. are gastrointestinal that important life approaches tract infection treatment therapeutics desperately have recurrent a microbiome can antibiotic-resistant has that provided mechanistic become role antibiotic-resistant, public including evidence also The CDI,

who at infection, Infection that Our restructuring in infections. SER-XXX patient changes to can addition numerous are multiple be Protection. we compromised pathogenic the that to are high we with gut microbiome opportunities bacteria, in to data reductions plan lead More We including there microbiome groups, in medically significant bacterial known demonstrates C. where and of significant approach toward can diff associated in threatening of our apply those therapeutics microbiome antibiotic-resistant. can that result life believe risk specifically, apply therapeutic technology to these our

allogeneic SER-XXX, stem to as which the Infection we next potential transplant. disease. These serious cell our at well in high we believe SER-XXX issues. patients SER-XXX receiving graft host that are developing very Beyond most versus risk both advanced individuals as infections, is are address And for for has program Protection

health assess Sloan Phase this be of data, subjects our GvHD. is malignancies, cohort as to to The ongoing such will or the subjects an and If experience conditions, the safety believe outcomes SER-XXX, treatment Chicago. the study Based these is we able first up University designed historical the partners X have we on would and of Xb We XX% The incidence we improve that engraftment working Memorial reduce XX over including these cohorts, infection at leukemia. to SER-XXX. set safety, and engraftment the of will of of patients. expect study subjects, trial undergoing with in assess meaningfully microbiome with for hematologic Kettering, SER-XXX for it efficacy

of will XX well as and associated we evaluate I’ll GvHD preventing as by clinical in infections further results the bloodstream assessing GvHD. the our pass forward includes SER-XXX and double-blinded well infections Ideally, would The randomized our in this of Infection rates design Furthermore, call with will a target outcome to administration. now reduced discuss significantly patients incidents future cohort as bloodstream should in we acute This only with next in future exploring and/or pursuing measured safety Second study trials, as in see broader to which support guide would colitis. GvHD and efficacy. further Matt? help Matt be acute in engraftment modulation. steps Protection, positive but plans future outcomes efforts studies. ulcerative not immune efforts to

Matthew Henn

you, Thank Lisa.

detail further we and during versus the therapeutic microbiome barriers protect As supporting that our the the the pathogen such January from designed has host therapeutic immune infections, and abundance platform in the enabled in preclinical to to pathogens evidence graft complications, reduce disease. to as discovery that infections. Protection. see event, of XXst patients clinical integrated for highlighted decrease strong reduce candidates data potential provides has Infection transmission, targeted Seres responses bloodstream our We the to to potential modulate developed we to an investor potential novel to both tackle strengthen of medical believe frequency of epithelial for

on to such of receiving the pandemic patients consortia and as preclinical success broadly. deploy SER-XXX, programs of infection SER-XXX These more solid Infection initiated also well and we’ve combating evaluating as organ settings additional slow as include the with are designing autologous antimicrobial-resistant Protection. cancer and We neutropenia HSCT in opportunities building targeting transplant,

program initiating progressing development towards XXXX into in the are and are programs over additional driving the We years. additional clinic next few clinical

colitis. a is may datasets. is efforts colitis that ECO-RESET evaluating Now, X our be for our moving announced our microbiome well and Seres from begin to it candidate, UC of I’ll a disease and some patients ulcerative microbiome with Last particularly intervention. UC Phase believe of results top-line area in for therapeutic an summer, a donor-derived targeting with suited efforts. prior we ulcerative recap we mild-to-moderate strategic investigational SER-XXX, study interest

to patients we placebo. of regimens well generally endpoint meet to tolerated. remission microbiome clinical study compared drug compared significant not the engraftment Late X that announced its primary on from data SER-XXX both placebo. improving across Our statistically Phase rates year, of last additional did average of The study to indicated SER-XXX that was dosing bacteria were the pharmacology

did impact. not metabolomic had we we therapeutic However, believe observe important changes and anticipated that are we that for

across UC. generation data to has been SER-XXX, to cultivated In from a distributed included Evaluation data include X placebo-controlled continue for candidate XX cohort. approximately also Phase microbiome that of safe Xb of Phase for Xb designed first study cohorts. evaluate we the therapeutic Preliminary next to independent SER-XXX, an designed subjects. is patients the The from by our addition Data SER-XXX rationally treatment be second XX the to Board analyzed which Safety data Monitoring the first would to cohort, it proceed cohort indicated study

area observed more evaluation there defined improvements efficacy FDA definition, of across Furthermore, And Three-Component this decades. therapeutics clinical period, we Interestingly, UC baseline in of the no metabolic the efforts clinical and on were and observed our we particular components SER-XXX following appeared to is administration a the subjects to and sub-scores. endpoint cohort, interest Based of that be changes SER-XXX While or continue to SER-XXX stool data, development that microbiome remarkably be is metabolic outcome data to subjects. that disease. including was more in landscape in heterogeneous of explore. an subjects individual patients receptive baseline on gastrointestinal of score, clinically tract. various has bleeding the indicated one rectal the degree endoscopic, be disease known metabolic the a not on the UC drug achieved profile engraft notably, to though, certain the based may remission bacteria biologically the trial dependent study observed This available hindered changes definable and characteristics. in frequency, we believe first in for using in were SER-XXX and

remains call our an I’ll area provide the this analyses that, With to overview ulcerative steps to in turn of and development conduct in we for research next continue to Our further ongoing, to colitis. now financials. David inform

David Arkowitz

morning’s Matt. are with included figures securities. approximately XXXX press the I cash details financials in million reiterate Thanks, of and quarterly fourth so the The and this of ended all Seres our full won’t year equivalents $XXX release, here. cash, marketable in quarter

expenses pay-off million we company the operating owed. to efforts amount amended the up to a near-term, proceeds debt amendment the related financing We agreement include $XX Hercules a remaining million we million. be we will which With SER-XXX Capital, preparing term $XX respect of today which critical to activities, down agreement providing the amended our are on number continue with over collaboration with and activities. longer that manufacturing and increasing and conjunction filing ramp-up continuing to with prior to for BLA with in our This of financing loan, debt under and term submission, operations $XXX product SER-XXX the debt is supply, including pleased our Bacthera have commercial our focused to readiness debt launch Nestlé, a announce supply accelerating facility and continuing last week facility This drew replaces million last Hercules closing upon received approximately $XX the we week. of

focus to upon to our expand and Infection with our advance In addition, enhance further a and pipeline Protection opportunities, build on and continue and platforms we capabilities. invest

commercialization resources preclinical I’ll development call SER-XXX where Eric. drive our priority to have these for believe generating and capabilities of of prepare result we pass back our and to the resourced a In already but we platforms, activities, as advantages. now have a well the we moderating increase value expect to advance rate while the quarters, high expenses we much programs, research sustainable our of proprietary summary, also expanded the is to in we organization. growth, differentiated, As across believe deploying company our to at coming ongoing and continue

Eric Shaff

with the study education expanded you middle and recapping the our milestones with anticipated drivers conclude efforts. working as by for on progress The expansion pre-commercial well XXXX. SER-XXX upcoming supply remarks progress achieving Aimmune, colitis; preparation our Thanks, Infection ahead. in execution analysis expanded execution David. market I patients, our for Health in readiness, open-label the inform SER-XXX data our including filing continued commercial These BLA access SER-XXX. key and success Can opportunity development in and include closely Nestlé Bacthera; of SER-XXX of to collaboration builds incredible serve SER-XXX efforts as capabilities, executing The area upon which Science, future our initiation our year ulcerative our XXXX expansion target longer-term value including initiation ongoing in of and program. to of of study ongoing will enrollment of an targeting directly Protection, our

research candidates microbiome preclinical clear mechanistic developments, believe our particularly well strengthen we to patients. have our to execute we where clinical we’ll to supporting our continue lead we the With therapeutic data in to is intend to lives microbiome and now, the efforts. also open clinical we expect that questions. new Infection call of In advance working platform towards on We and to Protection, mission, the hard and Seres positioned improve field, microbiome approach. operator, therapeutic up to continue XXXX,

Operator

Instructions] line [Operator Breidenbach comes of with Mark Oppenheimer. question from the first Our

Unidentified Analyst

is our This the this used are thanks is Hi, profile Thank for taking is defined My many Mark, metabolic how on baseline [ph] study good characterization? being in biomarkers SER-XXX question Jacquelyn for morning. in acceptor? and individual How you. first questions.

Eric Shaff

the Matt, to one? for morning, you that and Good do take want thanks question.

Matthew Henn

been that important in have been at be of in UC our are disease-relevant generated. that disease on important. we datasets the addition in metabolic suite basically that a for based to looking relevance biomarkers novel biomarkers that, we patients looking whole to And Sure. discovering had We’ve in at we’ve predefined we believe

consistent, Seres] and [ph]. patient biomarkers, specifics be yet few for stratification of potentially we identified that number used of [into but could have the we what biomarkers believe are tell can We that you is I haven’t spoken, disclose a that the

Unidentified Analyst

to based modify Thanks. good first of And Okay, to plan site observations from XX on compensation you or SER-XXX that’s patients? also, the know. do

Matthew Henn

Yeah, exhibiting the of pharmacological are is properties data so it SER-XXX with the that consistent to-date pharmacological our as their do. support and of was all that to properties drug design, designed

So we do not at the consortium. anticipate time, any this to changes

Unidentified Analyst

Okay.

question next SER-XXX. my is So regarding

think be XXX? difference you’re the mild-to-moderate defined based what development good of biomarker patients, molecules? continued of any populations, you fraction could profiling, also, the in for biomarker for there So both do and of on is And UC considering candidates – XXX

Eric Shaff

to want close comments you some And I’ll with do that Matt, one? that. on start

Matthew Henn

yeah. Sure,

represent patients patient So of a we still portion ulcerative do that identified we’ve colitis. subpopulations significant the think that with

So the XX% to somewhere be most the those population. of about XX% identified in on order to that receptive of have are we patients the

provided at that haven’t further We details than any time. this

Eric Shaff

Yeah, I comment. might just add a larger

iterating, results, are We worth and that I here amount XXX significant it’s noting study both microbiome. data with have learning, of clinical and think we a the

Now XXX I of first adjust it’s follow the XX and continue the and think learn will data, the subjects study we we’ll the to and worth results, study, from noting.

process intended it like positive made us we’d very the adjustments to. to efforts that we’re led and our we think it. another ends back of hope doing on We lot those of out a certainly Phase where in of with is adjustments take data, and UC, after experience spot. that look, in a up a you had we thesis clinically, kind study that the And what and and If now. results, to X let’s data IBD But have say, XXX run just lot number it to didn’t turns to maybe that’s of based we study confidence a that the the underlying support

Unidentified Analyst

That’s for That’s me. for again it really Great, taking our helpful. questions. Thanks thanks.

Eric Shaff

Thanks questions. the for

Operator

from Thank of next Piper with comes Tenthoff line question you. Ted Sandler. And our the

Edward Tenthoff

guys. you Thank Great.

trying if may, be prep as be BLA? much. into to the obviously, the also, so the set data with data? Nestlé, that that to I kind here. will company. of you together? Or launch strong goes So simply really or And the respect to guys reporting are you working for will Thanks relationship prep I’m with something then get just And how for presenting you exciting very BLA, the sense safety for better a a point

Eric Shaff

first I’m Lisa Yeah, hit Terri ask Ted, with for the start start start one, I’ll the to sorry, – with the Lisa, Maybe good morning, I’ll and questions. Terry, second. one. And the and second thanks the to to with to ask

out. first, maybe are we’ll we Lisa, the track it. following that, start you But just study comment and patients the can On process by maybe, of in further how I’ll commenting on open-label these still the

Lisa von Moltke

have yet, are to But Yeah, communicate. so and we’ll of our I finalized. conferences that soon to haven’t other public make possibilities we how will ways how disclose in dataset we that we said data say eyeing as those terms and as

Eric Shaff

Terri, the on just then, have together? And comment you we that work Science our with conducted Health pre-commercial Nestlé of work and some can

Terri Young

had, the guess, I’d start I the data, Well, Nestlé co-commercialization X by that ramped receipt we yet thing. last again Phase at of highlighting with efforts Sure data we remarkable the right, after these that, then data, agreement upon signing and year.

the our our on integrated in the now I’ll our being I’ll And comment in efforts. that, minute into together worked to market ask at scale her our led in we’ve we’ve and also dissemination back to Lisa’s data both also team. to to Nestlé access And team to education, her primarily efforts. So medical but are but hand – market affairs it a team, these

that quite by with also in of Eric remarks this Nestlé existing payer these example, accordance today that recurrence supported developing cost SER-XXX, a FDA to highlighted information and an pre-launch really has leading be treating that on field today. exchange. is limited. And we’re value are the recurrence is engage treating recurrence audience. his And, the in options doing with important profile patients, And For high existing payer in team pre-approval category guidance but after strong the proposition we’ll robust this

value big pretty of that’s on front. payer So front a the book work and proposition

at that understanding campaign broad and as last development. of positioning finally, throughout education like progressing we items market and payer move campaign HCP, brand efforts, our continue And XXXX. segmentation branded we’re be campaign patient to a amplifying launched will with also the work We them to we deepen disease year, opportunity we ID, and can

both of our commercial continuing into talent we’re organizations. industry to Finally, hire leading

the activities publication front to in Lisa, recent of Now, affairs the I’d in of data on New specifically particularly light ask, of pivotal in Medicine. Journal comment England to medical the like

Lisa von Moltke

as of Yes, the spanning the really the with programs, impactful fully areas education be discussions colleagues. are so and talking MSLs, Yeah, England planning was through on of reception of seeing and we’re integrated and in culminating team infectious we’ve Journal pleased we ground, working groups. physicians. being mobilizing we’re publications. that you’d and how including that there number are advocacy But in to part to their move with they’re that very expect the effort. Terri. an out thanks, their regard a patient The and publications, med New blending Nestlé new the to Nestlé efforts further this affairs with community, And also the are in of with There physician the group are disease, activities rounds, physicians heard already lots the on bringing Aimmune going group, up incredibly is Aimmune is

Edward Tenthoff

appreciate very I helpful, and everybody. it very Very, thorough

Eric Shaff

Ted. questions, the for Thanks

Operator

line question you. Peyton our the next from Thank comes Bohnsack And of Cowen. with

Peyton Bohnsack

our for I’m thanks on good for And Hey, morning, guys. taking questions. Joe.

you. So just been patients? share any Thank quick has question recurrence mostly have whether treated multiple whether How end how program I details about U.S. been? has this the wondering many And patients you been was about recurrence the a program? the access through demand expanded this in or can first real

Eric Shaff

XXX open-label can for would cover with I we’re of patient, been But, that? at but just getting started Lisa, just the we expanded you had the having included Peyton, targeting. access, the the Yeah, say, year end

Lisa von Moltke

can specifics, really tell haven’t it’s you we I running. that up given Yeah, and

We have patients enrolled.

can are. company, been giving you that so the across we’ve But future. haven’t look sites tried on the numerous information yet. site, forward patients more really strategically have And we the to place regardless specific we to in of access we numbers we’re – We where they them

Peyton Bohnsack

That’s enrolling about program. begin level also it X, you. that – any expand there that to was enrolling just Thanks. of Is to helpful. before to of be MSK that cohort know a maybe question sites? there I cohorts certain trial are finishes. And Or then the quick conducted? cohort it previously, then and when the number really the X at efficacy Thank plans was real you going would this said talked begin sites this required a SER-XXX is be Chicago with could the being and

Eric Shaff

comment Lisa, maybe can on you both.

protocol one the structure progression. I maybe the think, of is last in and the is And terms sites. other

Lisa von Moltke

Yes.

sites intending X we at and increase right We’re now, those. were to

you’re referring safety question entire to of need what to follow-up think over the We with long year. first that of a the that an start for pretty part your the year is don’t is there I cohort. second entire to over cost wait So X

set first patients safety And safety that to of through sector finish without free the initial the year The waiting go first into follow assessment. has an second at we’re point, to entire up. that of

probably you’re I what to. that’s think referring

Peyton Bohnsack

That’s exactly. All Thank much. right. you so

Lisa von Moltke

Sure.

Eric Shaff

for Thanks the questions.

Operator

Goldman Sachs. Thank from you. And our with Shibutani next question comes the line Chris of

Unidentified Analyst

trial you’re the kind must question. one could Chris. or language include on with first I how population? versus your on recurrence XXX have And comment you just then a expect would if prior on program. X Thank this for label recurrences Thank going Phase you our you. to seeing Do Hi, on that the taking XXX? patient had for these of is that [ph] many you patients Steven [after]

Eric Shaff

to want we’ve right, XXX? sure mean I Steven, programs, or make our question recurrences. around you that got Do with numbers was the XXX

Unidentified Analyst

Oh, yeah.

about Sorry that.

Eric Shaff

No Okay. Yeah. All problem. right.

absolutely let you that for again of of the the And on before same part to time, diff the process. ahead label, At that. patient that. we C. is happen want think and appropriate that don’t think will negotiation be that pass Lisa, to look course, we we BLA think handed that So population. patients [that get as and recurrent that I of is me why speak We in part can the certainly line] FDA medically, will to the with what of our view maybe, said is of Lisa,

Lisa von Moltke

the those And because suppress as Yeah, that disease, a the as I physicians the into practice start makes and marker the sense either about much we’re And in everything primary to and that’s think indicating from well as my pretty or is it standpoint, recurrent of pathophysiology both unable that infection a primary point restructuring. C. else. how is physicians else. germination pathophysiology with basis are which first at see to our And falls well think diff interactions it’s from to tend microbiome spores. recurrence disease, first happens, they bout recurrent everything as

appropriate reasons, as label So patients. Eric recurrent for this reflect therapy, we the really the with as said, see as But agency. will all negotiations an those for the but

Eric Shaff

think I the you that And seen have maybe past to open-label, as kind disclose the that haven’t mentioned, period once disclosed follow, opportunities those on in first just eyes recurrence the asked percentage data. data. and had we’re we’ve we’re follow-up of of But we our about Lisa the

Unidentified Analyst

Thank it. Got for our taking questions. you

Eric Shaff

question. for Thanks Sure. the

Operator

Thank from John with our question Canaccord. Newman comes of next And the line you.

John Newman

there team. and taking for question. thanks Good morning, my Hi,

if will across types label. SER-XXX as cohort. chain interesting curious patients well short is sort the the fatty data. patients in types noticed consistent many But prepared of products, remarks, your changes modulate I which in So as question about release just were and SER-XXX the did those those first you your of of off chain take mentioned in that press acids, medium actually relatively that

at? to was in the on based changes medium parted But that patients that fatty you acids, consistent the looked mention did XXX. affected curious, short metabolic Thanks. that across the just specifically You on by chain if state somewhat

Eric Shaff

Matt. to set. it about So we’re I’ll that with talking But thank it’s I’m and question. the some qualification remember bit I’m to to morning, going analyzing hand the you have to are the XX the come it’s do good John, limited right? data for to Matt. a pretty so first that you from Yeah. subjects, just datasets it. and a to have – we we’re And said, we maybe But process quite of going And it. going hand interesting, from of it think in learn

Matthew Henn

couple of of a points. So good morning, couple John. – A

subjects XXX. as first, colitis ulcerative was started So I with XX in

fatty tract. optimized be think can certainly and their results. short-chain I exhibit. to acids functional we’ve I are properties medium-chain focused certainly patients metabolite is cautious But others and amongst are biomarker to not identified. respect that certainly an the are modulating important to extrapolation patients, So are that it’s and the baseline. a mechanism and we produce, will as multiple context and that to in parameter is clear that pharmacological variations well. in certainly we you be of that important the there need population inflammation are that And fatty of short-chain gastrointestinal know certainly designed population, the others acids terms to we that was patients well, SER-XXX in designed it in heterogeneous assess on. the at that tell that as And at evaluate, focused can that reducing are demonstrate acids particular UC fatty with these of you patient There that and one in see is and But we on those that one the multiple SER-XXX continue medium-chain our the

comment the your we’re benefits those that bacteria of evolved of that I the at of off acids, of to bile to producing which need and second the metabolites, effects. acids think to seen to with things technology these important cetera, course, question, will, that’s and is where bacteria label, of these another think to be. activity and of taking these or just most things is is part – that us not one relevant important a as that is compounds, what’s taking on previously get folks to of question success it’s drugs our are while need your you you have sort it’s you short-chain what’s like et made The about site part and be fatty bacteria if they using – naturally the our drugs patients I comment because the have that, clear other where the or site vitamins, have And and is a

to. producing at bacteria that site want the the the we So metabolites them

John Newman

great. you. Okay, Thank

Eric Shaff

for the question, John. Thanks

Operator

comes Gobind And our next question line with from of Singh the Securities. JMP

Gobind Singh

to a wanted talking if with to And around share difference the dig and know indicator. more I the think, XXX That way know or you and just about compared little just to on XXX out otherwise, here. baseline This thereof. quantitative there, data could or congrats positive Is I the seeing there’s confirm our feedback XXX. be a say only Hey, into and patients that profile any the positive presumably would that engraftment don’t the the I optimizing seeing? that could since XXX comments bit level there’s if I And the and the remission, metabolic would my contend clinical that changes questions metabolic thanks changes, towards to any for about be taking that maybe we’re Thank and on accurate XX general you. a great. compared metabolic to for how it possible lack profile, was from or that towards it could dependent XXX, there changes and were was metabolic profile there’s could robust, would the that maybe meaningful progress. or tend be any now guys with we’re you if talk are

Eric Shaff

for in this in a there going some of – – to Yeah, – data. depths terms process Gobind, good morning, pass And that and questions. our of the your analysis. are it of again, we thank the questions so analyzing There’s map, the to I microbiome of you I’ll lot the be the just with in continue but caution I’m we do around

in learning a put of it our number put of our But help for return relates efforts us take striving to have there’s return to Matt iterating datasets on think chance ourselves others and And perhaps are it are we we – and than We can the the in success maximize that we’re position to to position in best there’s and based shareholders, to ourselves UC. maybe of and, course, patients there a a as in lot more have do, forward. to visibility for UC.

Matthew Henn

Yeah, heard I I in your comments. think Gobind, questions X

a the versus So of of metabolic bacteria population. and engraftment the in the SER-XXX SER-XXX changes magnitude SER-XXX cohort population post-treatment; about in the was second patients one X question was

to SER-XXX see bacteria respect did yes, with patients into of we post-treatment. engraftment, So both rapid and durable engraftment

consistently of on we at – you observed had second observe manufacturing of drug were X excuse study, You well form that in and the where as the think for sort were both the formulated to consistently do. evaluate we certainly wanted significant magnitude the importantly, form saw had formulated differences from And first have had reason, spore we have can variability certainly in the question the breadth of is drug tell which board. to our changes formulated the we multiple we can as and which it metabolites bacteria important the predefined think we strength both I speaks important testing changes, vegetative of you cohort engraftment trends capabilities formulation that company is But well and to we the I designed patient recall formulation of the as to the in because as for treatment that and in cohort well as bacteria. UC, of bacteria, and across engraftment, as this what and vegetatively that able we the And one metabolic spores, relevant of may of in a was as are to me, novel have bacteria bacteria we get patient. studies our shifting that, to we SER-XXX

good in we terms different as of SER-XXX of were to whereas anticipated not we in we the multiple and number Phase these the course did of magnitude In time study we metabolic that, that of surprise, noted points study. X also did significantly SER-XXX, predefined of observe a the the changed in had as changes was context and those the a at that

in SER-XXX. we So the more context changes of saw meaningful

Eric Shaff

a dose just Gobind, think analyze close is UC the where an to data group. do we right patient we especially given segmentation biomarker intriguing, patient saying, like heterogeneous by to often and about as the so with optimizing Phase about can I’ll continuing continue impact Yeah, the you will disease maybe that we think have X thinking study, on

those So are iterate we on. continuing to that are the currently pieces

Gobind Singh

the I making appreciate guys [in advancements you site] [ph].

Eric Shaff

the question. for Thanks

Operator

our And line next H.C. from Wainwright. you. Vernon question Thank of Bernardino the with comes

Vernon Bernardino

process Hi, to forward for everyone. taking questions looking congrats Thanks on BLA the my the mid-year. and

survey receive XX% What kind think And you SER-XXX, results the perhaps may during So prescribe state who not a There’s is rate their SER-XXX. a still number commercialization? think of prescribers, the in yet might rather highest target patient you definitely the you population do Do of implement conducted. a about with perhaps what efforts significant of significant not clinical that show to SER-XXX? driver you response percentage could that hesitancy?

Eric Shaff

on to different and to But going forward. is, I the based we we terms very size] morning, Terri [ph] we fact, a the did, of question. the that point good we But can the in would analysis from that Terri, take based that I’m Very conclusion view the heard say ask question bought thanks maybe [you you for comment. felt have back primary favorable extremely on from one of what what in our research.

Terri Young

right? is that look we’ve data, care what patient I the a is refer green. you’d illustrates obtained within what we in quite this prescribe our HCP something their see actually actually have the approach at that and sea you would feedback a deck you’ll So response, I – question. to corporate a definitely they And saying that’s or majority physicians direction, Eric. and SER-XXX, in it’s as are actually such great slide new a of recently mean, thanks, unusual. of would SER-XXX likelihood payers. both if vast to And and quite that’s it’s that probably remarkable current to that I for population, will And like HCP transformative, Yeah, a call the from positive use

that imagine your question in of smaller I percentage sort labeled… the is So are gray more

Eric Shaff

Exactly.

Terri Young

not. might or might a as Yeah,

in the this So very category. again actually new is typical

get You [ph]. fence-sitter I the what call

– they’re they and use a profiling you would this a research, paper, more them to just piece one them population, So of cautious right? on And physician patient your tend based you’re showing asking in set. you’re

data So the to down from wait little to depth. their understand specialist approval, for want to, hear example, FDA want a they bit more and they street, for the they want

that So these don’t But long. you’re for tend fence-sitters with. that’s very the sit dealing to typically dynamic

publications, from market how BLA the deal today of we’re taking affair approaches the approval, field course, it’s conferences, the can course, education around we approval. standpoint. force as of So with deploy through and then medical broader that our you And, well, do it,

Vernon Bernardino

I then was Eric, I’m greater that’d ahead. a sorry, hesitancy bar. implied, [C a sorry, there’s has like there I’m I [ph] low sorry, I’m do I go implied realize – a agreement] seems be

Eric Shaff

pandemic. New pleased even about would study this amidst No, this it commented data, comment. partners resonated, Journal affairs comment be we was and ensuring side, the the about as manuscript couldn’t they that that more say, right? the with to the we in about terms no, important work saw that data maybe I maybe I our was I profile. more do And with a which we momentum earlier of we just And Lisa open-label really the clarification. can have. think know really as conducted, comes the people than on into and of And, in England in appreciate just the down Lisa from very is talked we’re that to the we’ve we past, know have starting anything based We the good else, again the saw with feel commercially We we going it spot say, to the dataset think of has Medicine. med the acceptance can you technology, that

Lisa von Moltke

seen really people folks this think, overstate to to of I Journal I’ve who’ve who alternatives, of I the really I’ve heard position physicians, use not to in watching within the blown peer-reviewed. whole I be were I peer-reviewed I potential now the so impact really and that in other particular see data many the also the can’t from say contacted think I data to England only for still been am wait can’t paper who the it. and can or on we’ve wanted seen for I dataset, In dataset and solidifying able and that and from skeptical New journal No, just a myself, us Yeah. said, that somewhat have away, the FMT, hanging still now think

to well education we need be positioned able the do. So that I do think to to we’re

Vernon Bernardino

like you and question congrats Journal guess, thanks the is for the taking of going New are fence-sitters. Thank I and on you my in. Medicine England help looks the progress. to with And publication the

Eric Shaff

Vernon. question, the for Thanks

Operator

Thank further you. I’m no showing questions.

with further that, for back turn management any to remarks. I’ll over the So call

Eric Shaff

your call progress for on day. Seres. continued We a hope you thank look for Thanks that I very and to and our our everyone I the everyone in interest want updated keeping will great has today So to forward joining with you thank conclude, much.

Operator

Ladies concludes and you you and gentlemen, for may now this participating call. today’s disconnect. Thank conference

Seres Therapeutics (MCRB) 1 Mar 222021 Q4 Earnings call transcript