MCRB - Earnings call transcript Q2 2021 | Seres Therapeutics, Inc.

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Operator

Good morning ladies and gentlemen, and welcome to the Seres Therapeutics Q2 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Dr. Carlo Tanzi of Investor Relations.

Carlo Tanzi

Thank you and good morning.

be the update quarter AM the became this and with and financial Eastern company's release Investors morning, business the the available can website. press company's section XXXX second results Time & Our News on of found at X:XX with to clinical products, I'd to agreement studies, of to availability of safety of therapeutics. our relating microbiome the approval, and that enrollment the and our making forward-looking of we'll any the anticipated the like timing, be results regulatory of success operations, you our fund impact statements promise remind sufficiency the Nestle, of our profile potential and cash and results differ Actual may materially.

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

Eric. Officer. During Strategy by And the also Chief with Dr. and of I'll Officer, we Lisa Moltke; and be call, that, our the will Q&A portion the joined von Medical our to call Chief Terri Commercial pass Young,

Eric Shaff

morning everyone. for and last good period Seres. been you, Thank eventful months Carlo, The several have an

signed to our and conference Science keep line We and North SER-XXX agreement and CDI intend programs top our SER-XXX generation clinical ulcerative and region. program infection. make brief. relatively for I we two have colitis designed our today lead also C. held towards program, Last important SER-XXX the our will with with next to obtained results We clinical co-commercialization development We today, filing focused rationally have recurrent calls on Health pipeline begin American made for we progress candidates. covering progress SER-XXX, we BLA difficile SER-XXX with Nestle the advancing month substantial continued an remarks our SER-XXX.

Our to open-label a complete BLA to for SER-XXX high our and filing. are study corporate the safety database prepare ongoing quality through top priorities required

pleased patient progress on the open-label targets We are very full with are the of study XXX quarter. the this our to with enrollment later we achieve track and

also in and Our Nestle agreement July organization early for an this is Canada. perspective. commercial successful also both includes to a capital well which into to we to therapeutics, development with up to and of entitled an this approval commercial of recurrent preparing The in million. amount Nestle of FDA milestones, be to XX our Health SER-XXX, as could pleased XXX Upon of including stage upon and Seres is Seres an eligible believe additional to To CDI. platform XX% SER-XXX effort with of our terms launch. We payment from pipeline commercialization, that Seres from substantial States a received SER-XXX the entered The of United transaction commercialize SER-XXX the agreement and positioned effectively achieved drive sales the and transaction this upfront license provides preclinical SER-XXX programs, through suffering total for capabilities. XXX million approval an target is Science to agreement, the stage our bring will support XXX Canada. well the equal We're Seres as is microbiome million strategic Under continued profits. financial jointly in upon million very patients earlier agreement, with

effective terms global previously rights a with XXXX value. efficiencies deal. global work Seres, of has collaborator SER-XXX benefits our There Seres maximize been has forward. and and of to that are - to marketing, them SER-XXX Nestle remember, been a in pricing strategy, moving Nestle to ex-North and executing to to and an regulatory great may considerable closely to continuing on American you other As owned launch we based reimbursement, will aspects commercializing look approach forward

month study, potentially achieve highest substantial approaching our SER-XXX first The months enrollment requested study fact, would The We the result follow-up $XX,XXX expect therapeutic. The that we substantial approval would in our represent SER-XXX and and microbiome we FDA SER-XXX late enrollment recurrent for has open-label is in Completion group. of Each a to estimated X and the commercial BLA summer, has to open-label CDI represents a study become to approved the product. the recurrence steady target positive this from XXX,XXX date. ever filing launch patient opportunity and this community in Seres. interest was in observed been awareness FDA six approximately in of the approved now July we Phase first we've Since major excitement SER-XXX has U.S., and The the direct a of entire for announcing database. we ever enrollment, therapeutics. to in addition, represent expenses. our for the safety of SER-XXX SER-XXX field last to approximately believe this become will quarter. of ongoing event a also CDI in increase in the been the to of cases in enable healthcare requirement opportunity database safety support address landmark completing to have full and believe FDA SER-XXX microbiome enrollment be medical population and to seen that this included a third the in includes SER-XXX believe this data

pipeline SER-XXX, of additional SER-XXX reported results Phase X advancing X focused on clinical study. we Phase investigational results obtaining now with are to of study. In the microbiome line mild that patients addition study this UC. SER-XXX results and not demonstrate we unexpected, from did therapeutics. were month, our benefit to we from moderate study microbiome in Last are clinical top The The

data the study were from prior expect the deeper why with to Xb us We these a different and the of so Phase outcome, understanding provide much study results data.

addition, these with our SER-XXX, for us including provide that next to insights of investigational will ulcerative inform our results colitis. pipeline, provide candidate In valuable continued generation will development information

therapeutic stage SER-XXX to programs. from Matt successfully now we program, the months, coming all with efforts. done have Phase pass our what determine to modifications data, implement scientific the As future of our call in analysis learn pipeline and I'll our earlier to in-depth we an Xb intend results, discuss in to microbiome development perform the

Matthew Henn

SER-XXX dosed, UC the and and rationally candidate non-clinical associated of with the decade the next SER-XXX, we from of orally Unlike derived designed have that the the modulate contains is metabolites designed epithelial selected Eric. of intestinal our and produced products identified Xb the ongoing associated activity, potentially non-clinical gastrointestinal pathways continues terms The can with the a Thanks, and been Further, IBD integrity, TNF optimize microbiome drivers and relevant treatment specifically our a gastrointestinal therapeutic our properties immune healthy in they that research improve in cultivated have a are in pathways differs support specific bacteria Phase targeted to those research of microbiome suppress as bacteria know in past inflammation immune that microbiome Starting SER-XXX donor pharmacological SER-XXX and that reduction inflammation. bacteria ulcerative that of individuals have and cells, clinical barrier innate found adaptive are candidate, effect. composition many drugs IBD found for at colitis. Research GI. engraftment data the from driven and internal and pro-inflammatory important of of to the optimize epithelial and clinical and to with sets study. UC. is of alpha over species treatment anti-inflammatory that to the SER-XXX a is literature generation that modulation individuals of dominates unique

obtaining We and regarding study patients. the Xb support a robust are a future drug and being the measures decisions this The mild-to-moderate program. safety in study is efficacy are from to Australia endpoints. XX SER-XXX and enrollment emission evaluate colitis. enrolling study in of Zealand The study adults information objectives secondary New to target pharmacokinetics, conducted with and clinical for of the biological with We other driven data Phase to additional evaluate of development anticipate clinical as and ulcerative

host colonization, transplantation. and interacting is with are SER-XXX built to bloodstream prevent onset how reverse the SER-XXX. various high graft bacterial human as of genes, evaluate associated gastrointestinal we in patients to designed reduce pathways cell disease immunity capabilities cultivated microbes data in those the candidate to to infectious modulate SER-XXX designed and orally immunocompromised now dosed and versus well host therapy the on platforms microbiome that inflammatory receiving the host to with hematic pathogen designed company's the decrease another has an disease. and both in infections, host harbor tract modulate bacteremia tissues diseases. related is graft versus Moving a impact of rationally SER-XXX cells can that bacterial SER-XXX particularly gastrointestinal resolution one in leveraged and and stem incidence as disease have translational immune antibiotic-resistance to allergenic infections, obtained

Center, collaboration This clearance obtained conducted expect and University the in and Sloan leading study Xb study of SER-XXX patients field development, begin Kettering clinical to IND a Phase Memorial We with be for academic Cancer quarter. have this to in screening initiate we Chicago later centers. will

our Turning now stage to earlier pipeline.

evaluate disease microbiome to integrate advance insights data have microbiome that customized high therapeutics. models based indications microbiome technologies, human engine data health. disease platforms assays, from for inception, in our in Since of and to resolution and several human Seres core model from biomarker at and and a we our signatures We defined from vivo can been research data screening building new continue cell with results potential

transmit microbiome with established of assays in platforms directly interrogate has action to models candidates. the and microbes in mechanisms lead our to of Importantly, both our discovery, The combination can de-risk ability non-clinical and of extensive existing company with disease of maximize help the humans pipeline, and of of our delineate target modalities investigational mechanisms of our advancement database to future therapeutics inform to the drugs. of and a targets mapping druggable to the these action a and insights caused,

and opportunities Our broaden the of complexity as fighting manufacture we consider with I'll inflammatory, antibiotic to additional capabilities, resistant broad David and high we as in unmet that, combined areas, provide neurological biologically our medical oncology, metabolic, with us overview scope our With knowhow pipeline. multiple to financials. turn been well base research enable and breadth now us advance infections, and positions the diseases of call opportunities a that's adjacent a knowledge few to these and conditions, GMP diseases. This of under technologies such platforms, microbes with needs, near can term autoimmune, and

David Arkowitz

financials include are press Health equivalents XXXX, with release, Seres balance in them quarterly ended was our received Thank X, SER-XXX Agreement, cash, approximately here. upfront $XXX approximately not securities. $XXX you, million of has from $XXX included this pro cash by balance that second upfront XXXX Matt. been the Including won't The our fee reiterate announced co-commercialization quarter with Seres License marketable forma The quarter details Nestle, the the million July following on so cash fee of Nestle cash June I XX, Science. morning's XXXX, of this and does in and million.

our BLA where advance So have is advantages. well deploying up SER-XXX for their term, believe lack supply, number given treatments, pre-launch C. annual SER-XXX of are we to efficacy commercial with programs, open-label our our resources include; on manufacturing our that our drive with prepare profile there SER-XXX. significant of to balance believe the the and a to we completing effective a minimizing of to diff, We platforms, stellar in over optimally commercial and leverage differentiated to Seres. continue the and are in as the study, cash commercial is and commercialization number we SER-XXX for has discovery operations accelerating respect near cases believe the current to a in U.S., commercial of efforts Nestle activities SER-XXX, opportunity efforts. research agreement while a the the submission, result success with company sheet and we focused critical capabilities and development for the ongoing U.S., expenses Moreover, related maximize to able sustainable we the strong conjunction which the of Nestle, operating ramping recurrence commercialization filing safety while a proprietary With of burn resourced

already access, discussed and has and Nestle. market functions, force as As capable we team previously, highly counterparts marketing function, have engaged from operations sales, well GI and sales commercial Nestle sizable such as is and actively our as established strong a our well supporting with

platforms and promising As research core Matt discussed, our are pipeline is capabilities our differentiated. unique and very and

are diseases microbiome expand and and to and to for our transform and patient continue we therapeutics outcomes committed pipeline, to our and will platforms to advancing build We enhance developing advance capabilities. invest Seres further

will capitalize and the pass we these now disciplined I'll prudent to While on in Eric. growth. be opportunities, we call this managing back

Eric Shaff

conclude to include; and our our remarks, recap we during year. filing. the this study like BLA achieving important full SER-XXX open-label milestones of looking forward enrollment are of we the third during the As These the to a of in several I'd that later year quarter preparations for remainder

enrollment our on study. from continued SER-XXX readiness, including Nestle working of of progress SER-XXX pre-commercial Continued education of Phase Xb Microbiome SER-XXX and enrollment on data the study analysis with Xb executing efforts. SER-XXX market closely our start expanded and the Phase

an of strengthen Seres the therapeutic promise microbiome in microbiome the to ever of approach for with we in continues the first expansive our our therapeutic by and expect leave literature, we decade belief are to also organization of technology. research, the optimistic With is field achievement platform therapy. deep over the future approved rooted, Supported a SER-XXX, capabilities. Our our of this

and therapeutics to scientific advancing We Seres a continue pipeline. field transition therapeutic foundation, treat that Seres solid will to strong we by a microbiome And we to supported - forward. Seres believe to is and expect draw our microbiome positioned make are the well clinical also balance progress diseases. We development is sheet. to lead new drive continuing into

forward lives execute on the looking the mission we'll to operator, call to for our forward questions now patients. the field With continue and of microbiome lead are improve that up to We open

Operator

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

Mark Breidenbach

Good for morning, taking thanks guys, the questions. and

a give the hoping me. I on Just of us could some filing that for couple clarity the timeline quick you ones was expected from BLA.

BLA and enrollment in open-label up half filed expect of in we of first the the If third question the to have can wrap second realistically months you the follow-up, quarter, six you of And XXXX? a sharp be how OpEx pretty the cash is uptick in burn guess just saw we housekeeping. we XXXX? remainder Should wondering Thank We I should quarter. in of thinking for you. really - about I'm second be

Eric Shaff

thank and morning, the for Good question. Mark. Yes, you

the open-label we of provided subjects So maybe study moving in for us with I'll for. critical that the one. the path asked the and timing to single second but - start I'll in the least support guidance, invite answer first David we're the enrolling and just finishing BLA, terms or for But haven't item the obviously gating and FDA at database largest to is XXX had the safety urgency

in open in As July we was month yet. fact, And made prepared we've remarks, our progress enrollment the in highest really label. said great our

and same across based will to So we move work quickly we the time, we're we're getting part as BLA, on interact message other at the to the possible. that looking the aspects think really that doing out is continuing in to key with of as stakeholders field. on work But the be

guidance, we indicated will the follow We've previously then we're open-label. as six know providers months that to for be for haven't patients we quickly we therapy in up looking to are available. finish the possible provided as So, as got move the we remarks. prepared whereas and the waiting that know And

we where the can we with on I And further OpEx. to on was question David as know, and Nestle, maybe are that. into agreement entered efforts pre-commercial leading for comment obviously, you Second responsible ask

David Arkowitz

Yes, thank you.

add in provided the near Nestle, sales the balance also preparing sheet and And quarter be to efforts SER-XXX profits as million. we well million high opportunities really term once strong as did $XXX note preparing on about the our filing of in splitting are to Important and our of milestones, for approximately SER-XXX, as $XXX upon well are balance that, commercial. of commercialization is activities We over SER-XXX with million will remarks pro BLA, forma up under in - of not have U.S. terms the focused value to future the as ending for we So agreement file talk in our additional cash prepared guidance. milestones, our $XXX approval there

of there's are economic approved we a and very ensuring we a lot from on well to launch. opportunities have an that standpoint, is prepared once So focused SER-XXX are successful

Eric Shaff

the to X that the I'll study. UC Mark unmet safety for think We efficacy and in field, a just need, And to that maybe that the profile very finish on by that comments. opportunity David's showed based is compelling Phase and earmarked the adding work the in return has investment remarkable we pre-commercial it

Operator

with the Newman next Canaccord comes John Your question Genuity. of from line

John Newman

were question. my did still you dysbiosis sure microbiome is anything know baseline The more analysis for curious based I bacteria. just difficulty] like if curious type of a you're [Seres], that or is there if for specific specific work XXX the taking XXX. in you saw question performing be not the think But Thanks pattern of that just side that might UC in effective, on that [technical you

it's curious if thought Just at a of pursue during that's this question kind you'll of just line the analysis. speculative but Thanks. curious a that point,

Eric Shaff

Yes, John. the thanks Good morning and question. for

the led happen spot me and the or can comment, And cut worth we with right. do changed with X. it's Phase up up I just when to obviously, the results Let some referenced or didn't diagnosis, ended in and we Matt more was ask of that analysis that types go think with we the more based it comment we or reminding out us post-Phase change of other the those of on objective we'll dose incredible the analysis. saying, all everybody for didn't in XXX, overnight, I'll about then the a ended specifically ask the thorough changed diagnostic scientific those more where great the protocols, It X that just And we dose, end analysis, we we'll hypotheses. only spot. was comment hypotheses. on we we the others. It maybe to hey, most the by based many analysis, came set maybe heels we and purposely which to way, to were That data. patients up we different can And XXX think the open that to is hypotheses into on microbiome compelling perhaps Matt approach many, we key those in I'll as increase and general was a after if ways data, two key And up subgroup you two analysis how which and this on us rejected specifically, dysbiosis open with that analysis the a analysis you

Matthew Henn

for John. Sure. question. Good morning, Thanks the

and for patient to in we that our SER-XXX how that and for observed patient who a look population. at have been will versus in done we And kinds not different in of may into to have backgrounds, has work if different at that designs to patient at have those the to of how strong trends of healthy in prior broad observe we example, actually populations did we've initiation understand, they drugs those that that look our those engraftment and across certainly understand a incorporated area continue past, treatment that differences that research any a ensure any may understand insights those there response terms patients microbiome is that settings. interact So important the response. had of the an did some example, we many drug And vary. association to across of individuals are company - a and kind to We of and signature baseline different

area active research. an of certainly that's So

what data at We will see we'll And that. the looking tell certainly us. be

Operator

with the question comes of Jefferies. Howerton line Your next Chris from

Chris Howerton

taking the for the Thanks the questions. up soon. and XXX for congratulations all coming progress very on recently And very excited

I And on one or information you on just give So is CMC question specifically up. for to then a mean, curious up if it recruiting more Is exactly was us I would questions color what some little second guess, XXX. more on - I supply the donors? could is is, two up just I that guess, relates just what for question more ramp maybe it ramp it guess that me, the focused would building be? as

really trial don't I know lot whole a the design. that First, think about we

disease. So be could extent to that the helpful. the thoughts interesting if on Matt, graft that for that putative be you to it'd then you on mechanism XXX hear host some Thanks. insight would provide can, really and really your And versus

Eric Shaff

Chris. we categories questions. for you say there and CMC, would last results Phase is our really what that On And accelerated preparing thank X the I that for I in following guess multiple summer, includes. work Good morning, the is commercialization.

and deep and was it recruiting our joined like foremost, I has Keytruda. you CTO, commercialize key in moving and David as from products new know, as Ege, to First experience Dave, know us Merck,

work So step. in capacity. were hands yes, to that capabilities making our Dave's that our CMC was one - continues. supply But and we to expanding have our manufacturing first of processes continued donor sure And in the yes, question, invest your operations,

So, and that we able fact was Phase commercial of Phase we've since invest comment and and But that in why supply were ensure because continuation process as we're without to disease we're ask has continues. excited to our partnership. the if X our on work a Matt reliably and of to results, X a patients the it can that XXX, to continued I study. well then it infectious XXX at is comment Lisa Maybe work about

Matthew Henn

Chris. which of a ability particularly settings These and SER-XXX such with actually immunocompromised about to the important infections, that we observed question, are that excited highly undergoing our is immunocompromised been problem, impact for stem something have are be transplantation. those as continuously really We're learn hematopoietic in Thanks the reducing different the of therapeutics Thanks We've learning patients for an that. experience resistant cell carriage program. our patients. and bacterial of could many antibiotic on our have clinical

as often knowledge non-clinical important all antibiotic a insights as with we based design that ideas could of clinical XXX ago, And other our born we the decided of that bacteria the infections, prevent drug help to also designed into actually a bloodstream. we modulate and that important And were epithelial carriage reduce drug we well on that could the bacteria resistance. the cause had, translocation bloodstream bacteria of drug we research could in is events and few the years immune a on the the believe barrier repair that of lastly, many pathways increasing to receptivity of research that where design based could then that are So harbor brass. these

deploying And those drug. three collaboration we to this core so been disease much out working Nature in a come are long there of time. a mechanisms well, has and over Kettering, has the area the results responses program have improved This patients Sloan years. collaboration, in FMT look as this that with Memorial Science published has quite past very of for at who to couple these of some And in promising standing been and with

this it’s And combining built So our with for disease and those couple think patients. upon important reasons. a it's drug. to But learnings obviously, program design also infectious One into going these immunocompromised we our efforts. expansion really of we're I that knowledge internal of an

COVID. are probably and we that infections humankind demonstrate, facing a demonstrate bacterial secondly, outside as anticipate second of the antibiotic is important. population resistant challenges this high that's to So of right And safety now, I'd one of biggest risk course argue population in

further. is space, to program an project with initial in that expectations this so And expand

Eric Shaff

quickly the you the just of want want question, do just then And skip the comment drug you on on alliance Lisa to design. so to

Lisa von Moltke

them of undergoing an hem that Sure, or as we'll stem be XXX. safety and be for heard so we'll voice, an transplant, outcomes. or as losing excuse is XX disease, you And for XX infection malignancy. open portion, my then And patients looking host me, Allo for well as at who cell this looking a in versus to placebo are randomized label usually graft

Chris Howerton

on symptoms? And Got you're versus it, to greatest expecting Gi know, is with to you the then the disease, say okay. impact it fair that, graft host respect

Lisa von Moltke

Yes, will be looking we'll as symptoms, as we Gi also symptoms at following be symptoms. but hepatic skin well

Operator

line of Piper Ted question with next the Your Sandler. comes from Tenthoff

Ted Tenthoff

time of ask of to now. XXX bit, would more can you Great, done taking be after you set do that say is the want with XXX adjust a any that not to the see around to cause of XXX digest I’m similarities sort study forward learnings I with kind But there's from are as analysis X? a studies? appreciating much XXX thank probably you you lot just Phase start little of respect as data pretty places some to you you was that or sort for about Is right the root today. that again the the possibilities Thank more process, very go the future one and and there applied you much. that

Eric Shaff

Yes Ted, question. good morning and thank you for the

the Let me start and on data I’ll comprehensively ask Matt to comment more a little itself. bit

would framework time. where with different patient between Different benefit I certainly we've in the we of XXX disease XXX. not gone of And through ways that note we learn that having thoroughly, outcome, the right. bottom what predict the - we're there's more differences, time, got which are result. as of that there's can it's can study and great possible. think designs, a different there have and comparable, did and populations, At similarities up we science, as from I will line We're the lot follow And last is Matt programs, think did process, differences right. different going do But what a I maybe we we're to this that's with going not ended this up to interrogate set where And fully go. we we the comprehensively also last comment areas, same I time, I the or think confidence - the on And structure to is can it. are this.

than developed late from us the that I'll not but Ted, our learnings in were with Matt, now course, take to made is I we I could I can will be have XXX actually question great working and which And lot in to far that's and one to make better ago. analysis, for too of tools ways XXX. answer there's of odd this years fact, to in that maybe benefits we'll but ask think in accrued the then second to of our XXX We've urgency reasons they are it If sharper progress fully. think over more we insights XXX. comment four hand a Matt. adjustments

Matthew Henn

And Eric. the a X designed trial Yes, pharmacology. Ted, for data I set thanks inform drug thanks really to the was activity rich question. Phase to Yes, and XXX capture think,

we types drug that that data sit given activity pharmacology. the of so we And and generate use a in to really to strong position understand

including look transcriptional clinical we'll on what So the evaluating then metabolomic datasets. of we looking change similar data parameters, in to require the and them and context context at meta-genomic did XXX. in very of we the at changes the be these And data,

very each and similar respect of we're was well engraftment know host microbiome you pursued. things drug of to will be disease it at pathways those manufacturing looking in and forwards sort changes we like be of potential various And of course, any we'll process measures associated activity, of looking modulate metabolites as as know, so and any the buckets for, at looking well in terms response. So what that and backwards clinical, with certainly three

is data very - one, think kind I two rare. interventional rigorously was those by collected of thoughts leaving which you are with close So sizable, I'll this set,

this driven rest solid broadly. and with will R&D Eric and information our UC our we that programs. our our inform, our tools, insights important And And both forward and ability to drive portfolio opportunity, I'm also a think team the confident of out, more that rock particularly a advancement to program really pointed the provides that that the but team of program, inform mine so, us I data as an have to

Operator

comes from Your with line Cowen. of Bohnsack Peyton next the question

Peyton Bohnsack

the Joe. terms This Thanks is Peyton on for taking could in be et quickly, outside also you if were We signal for share about cetera will that's also our expect if any then the to has can any database they're secondly, to of from Good changed that safety FDA the the at morning. study? potentially at patient or if on look SER-XXX how questions. accelerate insight Thank really indication with secondary were then safety will the signaling expand all. you And you any were trial you what and of made what you. FDA will or patients if expect about we Zealand number New share And reoccurrence, there wondering curves birth looking breakdown the plans for, wondering database Australia be? in FTC

Eric Shaff

the is Yes, our the to you the know, first is, the Thanks take which what satisfy Peyton I'll We're BLA. FDA requirement. that for from in of And very on we're for as maybe fulfilling to the dose has X. first part was safety from the that subjects asked what you as the asked Phase looking at good really foremost and supporting said, winning for questions close XXX least the study they've getting morning. perspective, database one, for

may again, recurrence is our as other there have come a urge goal really a - also or with we a first our will a or think first is study to data breakdown reminder, until you And, it. safety. of from know occurrence, there just will competitor that is multiple projected not actually talk resist and there arm. reminder, about not the the as I this be But what objective we breakdown even maybe

So Phase I be the placebo X insights relative will the study. into controlled constrained efficacy, certainly think to

just where a consider on XXX, there if as the leaves XXX adjustments. it's As question. I good it do impact then an we'll XXX say, patent, analysis and those to us. need far And potential we see is would

late I we'll it's adjustments follow too my us the in and, for As not answer, but different data. about I to think think said last

as So it's us open or we premature could geographies. whether additional up think to sites new to speculate probably I for

the XXX and what for is says we'll if analysis from there. see it Let and relevant go

Operator

Your next question comes Chris from Sachs. line Shibutani of with the Goldman

Chris Shibutani

which the to to about you the would completed any you're us gathering to clinicians, obviously what data going ability you potential able nine Thank do? give much effort. questions. educational to database. to provide an going you through the approval if be anticipating you've talk Obviously, going be the XXX this to continue process XXXX, follow-up specifically But of physicians talk is going to safety and XX updates Can to your pre-commercialization what to about approval the go the about enrollment that Can filing the during you're to And in prior months. of very you Once be is you're for BLA talk work? process?

Eric Shaff

you question. we have team. morning. don't But here this answer morning, and a the you something that Yes, we're for question. stand Chris. an for as thank Good It's It's a good about I as talking actively

been to and finishing And on I let come say close But discussing the open-label. on after we what we're keenly are think said, would the back we question. as to very has open-label good focused completed, that we're I us happens that. pretty you actively

Chris Shibutani

guide question the North more up. Mark's incremental expenses, level on to of basis? R&D initiation a step of an little we about and Should it XQ up anomaly the as a sequential follow quarter American SG&A the agreement? the To forward spend perhaps Or that second from reasonable an think go reflecting towards a bit Nestle was quarterly operating was spend on of

Eric Shaff

David more let Well, that. on me ask to comment fully

David Arkowitz

prudently. And it only thoughtfully. do to thoughtfully that We're going Chris, not going one as product. activities Hi, to said, We're we're SER-XXX going we conjunction Because to appropriately pre-commercialization it with launch ensure you. to thank this we that And in we're Nestle. going have and doing we're opportunity can. we're guidance. Yes. we providing do sufficiently resourcing to ensure as we're as Look, the

about to don't it, at how additional I that. but as we're leave it So thinking really it's think information helpful provide just

Matthew Henn

have just we the on able need sense XXX to going steps I'll in add, are pieces as maybe including that with keep to system clarity Yes, in additional be next an - Chris, a are there forward, example. mind additional better

Chris Shibutani

a you safety an update this be an and anticipate When then Got talked with there? efficacy you FDA, which ago to the final striking. a positive do SER-XXX, in from provided one news I that it. where what you obviously provide the another on and will database, that September, you results release, very were occurs, have the with with And - imagine interaction after positive will complete was FDA, you the you year actual occurs meeting? correspondence about us if And

David Arkowitz

quickly continue I'm I don't FDA, But all the to with aspects Obviously, on working quickly designation we forward getting connecting possible. we we not this think the breakthrough and open-label Chris. on said - to forward we I try and will BLA program, we the with the we're item. the other to with patients as of of as we remember, been the focus move to Yes, as moving to that urgency clear have guided to of possible. as guide them sure behalf the can FDA we that, connect are to is really this path as once the can that we've with with critical FDA, have look we that. is And going say form exact

Chris Shibutani

July to you Glad August Great. that. hear as strong, well Thanks. well. was wishing for

David Arkowitz

the Thanks questions, Chris. for

Operator

Your next line Keay Nakae question comes of from Chardan. the with

Keay Nakae

patient from that describe Nakae Keay the differences Chardan. in about any patient the and specifically Xb Xb you're from population you population populations or It's you Question patient study, XXX? for mild-to-moderate Can enrolling? for XXX

Eric Shaff

to take Lisa, that one? do you want

Lisa von Moltke

Sure.

study. allow which do naive allowed have the we patients, not biologic XXX not that were study include in the failures. we said So And does XXX

differences some populations. are the there So in

Keay Nakae

to some up? much that questions. is capital benefit rationally involved then Thanks. just of then that ramp And manufacturing ramp the up will designed in talked company what Okay. products? back how the also about with And you future of your Have aspects

Eric Shaff

Yes, a good question that's Nakae.

of think terms We a folks CapEx number beginning XXX, of perspective. question. the of I capital how from I we're do haven't in the think guidance for that allocating which it's was what worth a - provided reminding

stainless tends a manufacturing efficient, required even to and is other think small be nimble, liters not people differentiated, support the surprised as we result, are it, I typically capital think capabilities are it steel modest oftentimes, to therapeutic XX,XXX that the our though is relatively versus network bioreactors, right, modalities.

to As the the side setup, complexity things, the house, relatively it even chain. it supply to side resource synthetic relative the too around of efficient relates don't biological because we have a of is

capabilities of to forward, our and we investment. continue So will about support good to an area we going are, feel it our where continue be to pipeline

Matthew Henn

here. Matt Keay,

are course, cetera. stage different how assays FDA, late release there portfolio. the programs that's they're et addition, for at in so have and out between well that required I'll commercial. a in the and are what helping important manufacturing of pioneer needed another even that internally and do terms qualification thing and identity we're or here In assays develop X. in that's and moving those particularly validation provided Phase And and Phase advances those to field of positioned, of those work assays of to and substantially meaningful of terms we releases higher way And And the feel potency is those methodologies, anything we - been synergies a developing purity for will point than we in level the is, so and across help X the the course,

Operator

the Thank no conference to like showing now would back you. further at am this over I turn I time. questions to management.

Eric Shaff

interest very much. updated today thank conclude. you, progress. to And that Have look keep joining with want to on your continuing for great call thank you We our Seres. and to Thank continued in everyone day. a So and operator, for I you forward we'll our

Operator

Ladies and have your gentlemen, you Thank day. and participation wonderful this conference. concludes for today's a

You all may disconnect.

Seres Therapeutics (MCRB) 3 Aug 212021 Q2 Earnings call transcript