MCRB - Earnings call transcript Q2 2022 | Seres Therapeutics, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Q2 2022 Seres Therapeutics, Inc. Earnings Conference Call. At lines have been placed on mute to prevent any background noise. [Operator Instructions] During today’s call there will be question-and-answer session. now conference will to I Instructions] turn over the Dr. [Operator Investor Relations. Tanzi, Carlo Please go ahead.

Carlo Tanzi

and Thank morning. good you,

the Our for status at that, remind and for found cash its the a forward-looking Time our a press as company's financial results making morning safety and we timing on SER-XXX statements, business differ therapeutic, product XXXX market of use to release this including filing first-in-class the would and News statements, update of will the the company's other Actual and website. Investors SER-XXX, be may materially. became which potential sections and can of approval I you available operations products, the and for BLA not X and a Eastern are quarter fact. AM ultimate potential be second of fund efficacy results launch, data to like the historical

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

I’ll will Eric. over pass Q&A. our during with Additional that, the to team management available call be of members also the And

Eric Shaff

you, and morning, Thank Carlo, good everyone.

all clinical company's efforts, to manufacturing, in commercial development including the the make business, of continued areas have strengthening meaningful readiness, and progress sheet. balance across We our

for difficile recurrent Our is candidate microbiome SER-XXX, our infection. C. top therapeutic priority lead

IV upon ECOSPOR how potential see patients substantial the provided build observed in by as patient profile a clinical also of profile with including profile our managed, many If suffering of has a clinical confirmatory approval on therapeutic. approved ECOSPOR we microbiome SER-XXX III we completes consistent study ECOSPOR evidence well population, commercial data provides safety research, represent microbiome an discovering position two to a approved, have of further CDI. now these BLA launch. a these positioned strong this that III of Based SER-XXX results patients Furthermore, the additional FDA, could believe, anticipated to are study over well III. delighted review FDA FDA's by the important overall regulatory and we results program to conviction the confirming SER-XXX, new Seres efficacy Furthermore, novel CDI treat therapeutics robust observed of supportive in well this that recurrence highly from from new in class that remarkable progressing with with in of in from Phase current opportunity This These for diseases. product summer, represent the could a decade in and remarkable evaluating continue first has has studies. our an a tremendous we those CDI. serious if favorable the the safety and includes a Earlier Together, medicines. data to as potential in is SER-XXX program therapeutics transform deepened believe observed data broad first strong to established recurrent that recurrent We a data we CDI. support IV filing. safety the observed is database III options to report requirements a with and ECOSPOR developing leadership and The efficacy and were predefined study ECOSPOR development the

is fulfill are this previously we by III on summer, single file statistical for a from our we to has payer education, Leading and market preparedness these Nestle to patients we enthusiastic opportunity complete review the launch, study our we prioritize breakthrough cases acceptance for and submission is XX,XXX the the in priority ECOSPOR initiated timeline, launch. deaths with month and period. allowing This a and track FDA patients options recurrent to Health CDI review FDA period the half medical Today, therapy that year. commercial XXX,XXX engagements. where SER-XXX of tenning and have in six feedback thresholds to commercial be We we community CDI an to Earlier communicated a approval to opportunity health As followed requirements BLA the of two FDA pleased Priority of to treated resistance. regiments with and procedures provide weeks. anticipated that fuel launch disease result Phase courses be including commercial activities, expedited us first antibiotics clear over designation by clinical up are the the of SER-XXX need. expect to with per data the antibiotic (ph) BLA In in a SER-XXX Science, that from threat encouraging, are year. we the to III are FDA have including successful efficacy that anticipating per has U.S. not approved, were are surpassed review. The remain of may we available in in BLA. extended with a we external approximately recurrent patients we should today report we month to process been being submission the with we adequate risks. rolling continue patients that the SER-XXX to the some highly the the SER-XXX coming significant continue which may treated public help for discussed, obtained XXXX. did believe Also, not Therefore, will about treatment may profile associated know collaboration related SER-XXX prepare have the received

we production continue commercial our scale demands. prepare to to for addition, market expand anticipated of SER-XXX In

external In at term addition anticipated continue fulfill patient to product to partners manufacturing launch, other demand markets with and both SER-XXX well. closely supply longer as met manufacturing our to capabilities, both work increased ensure and worldwide in U.S. potentially our Seres internal we needs the to

we to our a company the also the I'd period recently in SER-XXX clinical provides for strengthened a approximately Importantly, like capital critical capital. Seres with we million more in to commercial initiatives balance new the now sheet enter of discuss launch. to Lisa call preparing support approval and successful detail. over This for pass $XXX significant as

Lisa von Moltke

fatigue. medical variations the across about safety reflecting by and we the recurrence are that was of patients patients ECOSPOR in address including initially obtain a included IV study IV only included healthcare These detail profile our a XX-week of group. U.S. CDI. patient who ELISA that was disease. subjects SER-XXX the Overall, efficacy FDA's in our XX also event IV was diagnosed not that the common study of June. on begin prior expanded enrolled are included the frequent ECOSPOR comorbidities. adverse population. additional to the follow-up Thanks, at high discussion flatulence, We population. common patient the percent the treatment the population reflect current very these SER-XXX abdominal designed CDI. well SER-XXX study, with Eric. provides indicated to ECOSPOR first favorable XX data, Based In I'll consistent one older obtained were or ECOSPOR treating CDI pleased entry opportunity had data PCR with tract study. with a the follow-up. recurrent this IV, and toxin interest required feedback results infection recurrent that XXX this requested patient XXX also this experienced practice patients of we received reported issues also database patients tolerated, have designing in was the ECOSPOR with providing to ECOSPOR in of included patients either maybe support in distension, additional III level of patients, dosed through safety events efficacy in Along a ECOSPOR And prior study severe the took of ECOSPOR to FDA, BLA observe or filing. least to the XX.X% to in or IV, FDA, most XX% XX-weeks the with abdominal ECOSPOR a all SER-XXX emergent regarding IV, as pain, that subjects a of diarrhea, urinary we ECOSPOR by In nausea, providers in study as weeks total completing adverse this III from group an III assays, the Approximately IV In study with the prior with expected XXX safety database

sustained see were placebo similar study were to a diagnostic sustained III. were recurrence we of drug a treated of those observed qualifying none study, We or rate pleased subjects, substantially arm across clinical was related with Response in response recurrence related rate prior observed different Importantly, the and vancomycin We XX% which rate differ includes the ECOSPOR between regardless where investigator. clinical in or sustained patients approximately ECOSPOR very of similar observed to in eight similar did activity rate XX.X%. of first we response the the study regardless possibly XX% for level happy of population, is clinical a FAEs by rates which the of this XX% also to the CDI. This III. the not study were fidaxomicin, the an the episodes. From also the in very method recurrent of episode see from remarkably number of up they observed deemed response these at efficacy to used perspective, to measured week as clinical

the is be across recurrence of episodes. Our with population consistent in regardless to results pathophysiology its clinical disease, CDI patients which the prior believed recurrent first of are number of the underlying similar

sustained IV SER-XXX suggesting additional response we recurrence date, of profile reaffirm population. provide Moreover, summarize, marked observed benefit believe data provide patients recurrent ECOSPOR III have suggests tolerated to efficacy, rates. with ECOSPOR SER-XXX results to the our and that the the Based results if first results in activity the clinical could efficacy we entire robust the extend Also, approved, So well CDI. across profile. SER-XXX, a in the CDI patients results. on similar of additional support benefit clinical safety of the for compelling evidence The

SER-XXX pending course Matt FDA now approval. will on label based of efforts. the and be utilization to discuss R&D call I SER-XXX pass the the additional product of However, would to

Matthew Henn

Lisa. Thanks

SER-XXX franchise. pipeline The our developing SER-XXX is for transplant. allogeneic receiving SER-XXX, infection is program stem cell individuals most protection advanced SER-XXX, we allogeneic with stem Beyond our along of which are part versus graft transplant disease cell host potential believe SER-XXX as patients the are serious both high very risk as at infection targeted address has SER-XXX to issues. by and for we well that

number these subjects evaluate are leukemia. of experience SER-XXX to and designed data, trial a of gastrointestinal engraftment on of subjects incidence safety, the safety these malignancies, patients. versus including infection bacteria SER-XXX If drug partners believe Xb a to treatment cancer leading is The we in host study engraftment we graft of the SER-XXX assess enroll as is alongside or undergoing tracts. will such centers expect pharmacology these hematologic that our disease. the would Phase study health outcomes to in this conditions, be in reduce patients at either meaningfully We of will over U.S. for improve continuing of the we for historical and to The able microbiome efficacy Based half

in bacteria The are the In either clinical with disease efforts trial modulation support of graft evaluate acute data reduced bloodstream including immunological SER-XXX decarbonization will of reduced future host but the Furthermore, to in acute is versus additional biomarker significantly will opportunity outcomes, graft with only of clinical immune incidence therapeutic also host rates a prioritize versus occurrence future Observing resistant associated outcomes assessments will this broadly. of inform that company's clinically rich of being translationally which help would compelling. that be or inform more priorities disease, portfolio and to target graft host bloodstream versus produce or infections addition, not administration will antibiotic collected disease. infection studies. of data study

preventing that organ in an pipeline risk transplant. detail highlighted believe and supporting Looking have at both evidence that the we infections, patients that strong and of for therapeutics neutropenia, microbiome are bloodstream potential particularly infection we are such this large preclinical during our in R&D we earlier clinical to provides in strong solid as event patient place in data as immunocompromised a ahead expansion, cancer high cirrhosis, in populations year, and investor team

responses to candidates. from and (ph) complications to threat the epithelial an and believe platform tackle to the of of biotherapeutics. infections immune we preclinical Seres disease. therapeutic can the to strengthen leverages of a antimicrobial which transmission, for bloodstream targeted Importantly, provide are development as and models versus see of activities platform This potential options translational graft infections the developed micro approach novel We enabled pathogens integrated MVTX continued and for reduce for reduce clinical, abundance human of further the in our reverse and resistant limited. potential of increasing barriers discovery medical such tackle the sets range to development host the therapeutic customized that has both novel pathogen modulate data data a broad has technology frequency to decrease

into initiating next additional that, provide overview now clinical on we the slow the antimicrobial success David targeting over turn and to broadly. combating clinical an years preclinical next pandemic additional building more clinic -- year. advancing programs our clinical SER-XXX I'll SER-XXX to of call financials. three starting resistant programs data of We are the anticipate of with the and the We infection infections With are

David Arkowitz

Matt. press details financials our quarter second are the in of issued The morning. this Thanks, included release

therapeutics proceeds meaningfully So be deliver resulting our term the operating collaboration ended cash approximately proforma XXXX $XXX Bacthera of the million. from in Seres registered the for direct registered $XXX to XXXX need. the Subsequent gross activities, all won't conjunction July, to the well approximately mission in of second quarter a reiterate figures enables through end launch use sheet to equity equity clinical on June and offering over SER-XXX to microbiome quarter, bring purposes. and in balance the of and the million. for second respect company We expenses of with expanding this XX, the near proceeds inclusive the million balance here. and more to and cash, corporate equivalents manufacturing offering on announced The effectively securities. we in intend efforts market, supply $XXX of focused direct readiness marketable related we patients our term, and to I the SER-XXX cash commercial our capital was EU offering continuing With from ramp product number with manufacturing readiness continuing support other supply the development working activities. manufacture Recipharm, commercial the including capital as further continue as U.S. capacity, as Nestle proceeds term to include general a up increasing accelerating partner SER-XXX as for market which This longer of for operations advancing commercial strengthens to with longer SER-XXX internally in critical and our our and net well

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

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

Eric Shaff

David. Thank you,

clear first weeks. As microbiome to you track complete coming BLA can as on we expect in the the to we patients, therapeutic submission rolling are our a see, potentially to bringing

balance with from which highly in succeed to and commercial provide product plans. support as We well a SER-XXX, highly remarkable plans. believe we capable launch Later profile execution to and we host collaborator event sheet as year, as are well a a execution positioned an we differentiated strong a have strong SER-XXX, plan commercial further details to investor regarding this with the our opportunity commercial envision our we

for and of an points. to that moving stage therapeutic to additional key look I'd addition where commitment today. would unwavering we patients. take earlier call to now, that With In open their for quality also ongoing their of and for new advancing are efforts, to lead the forward team the to opportunity program, pipeline we'll promising are talented tireless microbiome operator, to to like dedicated highly medicines Seres Without we life passion we thank be bringing improve we this our inflection questions. not candidates

Operator

Thank question you. comes Please of first go Your [Operator from line ahead. Instructions] the Mark Breidenbach.

Mark Breidenbach

our guys, thanks Good Hey. questions. taking morning, for and

you wait plan And Nestle be Europe. And you could submitted? Just And Street to Eric. a agreed when wondering, MAA BLA review timing still remains just had I'm do process the at if be have then or Seres? is going the thoughts is briefly a what can of completed? couple of filing the process the the you until summarize or has aimed before in will to to application probably the work kind regulatory both that a needs when be be process done (ph) filing an complete around Is on still application? can FDA inform to any question by by spearheaded or

Eric Shaff

morning, Mark. questions. Yeah, and Good for thanks both

On The FDA is, high in might BLA to excess as of in blow the expectations. came months IV the was can wanted you follow-up. XXX already haven't subjects, say past path of wanted tell in us, critical study what out kind of first, you ECOSPOR the remember, I process. study the kind would The at item of What by gotten right? they six were the the least blow I terms we of

gating and for kind to finalizing with BLA. forward of the is the was us that move So item

the further, we alongside are final guidance IV BLA. BLA modules mid-year can the tell ECOSPOR reconfirming is the we going course, and Of the in of in what weeks. I actually The Without saying the is, stages the coming Mark, were on working you other of data.

we pleased and where comment might not. our we're very what we terms of from we we'll very done we progress to So in doing. we're might today, sit with be that everything or we're that doing And need think soon. very, communicate won't I very be helpful

think pretty out. general, in be to they when I you've as have try that when we current to transparent come and seen we events,

and we're Mark, And about excited On also as We're diff that right? issue, Nestle bringing the just that would say, prospects focus I globally. the of U.S. doing with FDA we on of market, question, the been C. second so idea believe Europe, single is the global the a has our partner. course, SER-XXX while excited we're about around a

pre-existing You and strategy have relationship and remember when which our in we're to S. makes back even U.S. partners unquestionably potential in world. the made to addition it marketing process where and synergies branding to sense thinking issues is the of reimbursement there of -- EU might for rest about the in unified and global one thinking Nestle and to the and the of it regulatory our pricing partner, work sense about U. why with in are

to short continue we work have Nestle constructively on term and more to with the I say we'll in collaboratively So suspect and next steps.

Mark Breidenbach

already Okay. support anticipate launch sales Nestle from I support to is or maybe any Seres potential field And a essentially in reps one the plus the to you will Do be one that quick launch? last just place mean at force me. hiring

Eric Shaff

Yes.

the You mean right, U.S. Mark? in

Mark Breidenbach

Yes. Correct.

Eric Shaff

Yes.

of I commercial us Terri, I'll Nestle was we then where idle efficiency capabilities, having and think would from comment building who hiring that attractive sit of the or to for infrastructure then switch provide But until us working a some it idea it could on. not financial significant and was perspective. existing it leverage turn over quick we right? the with There was aspects approval me to one additional can So that

which the quickly, on we us could capabilities are leverage specifically we allow But Nestle -- ourselves. value, more on think ultimately, your more more can can will comment effectively more get there force. the around and to we So Terri, maybe from that create than sales you question profitably do patients

Terri Young

these it's where the and who potentially existing how highest and guess to calls colleagues patients potential no we'll greatest start the I is And seek to infectious infectious I the with the Well, gastroenterology disease reach to for Sure. gastroenterology disease large institutions. have the a we'll other treating surprise gut patients. concentration our so with to into continue an determine augment work This reach these that infection, would we of hospitals is, Nestle relative sales on HCPs and specialty at and have force practices want into that specialties. now to to

work you, these leverage. and the now efficient And that's will to versus So our with ongoing that to forward capabilities Nestle at most lot that teams. we continue a that's vision Back building capabilities is have experience But ourselves. of great that's out the path Eric.

Eric Shaff

think So any it. that answers I questions? that is Mark, other

Mark Breidenbach

you the for taking and Yeah. forward That's the perfectly good. progress. questions congrats Thank on

Eric Shaff

Mark. Thanks questions, for the

Operator

next Your Please of ahead. comes from the Peyton Bohnsack. line question go

Peyton Bohnsack

taking that would another later this morning. to that. questions. Thanks. be, be event is if And Good Joe. year? our when I mentioned be be study. we would just I've And would analysis would investor this see guess the any that Peyton This -- could or at additional that for you for year Would then label got for conference? a able open Thanks in you after first one one included the be

Eric Shaff

IV. from question. the for Thanks morning. Good [Technical ECOSPOR Difficulty] data further Sure.

Terri Young

Yeah.

So Difficulty]. we [Technical of a mindful have and large data set we're

fall. see upcoming embargoed are additional to mindful conferences But data you are We I’d as those soon. also those actually of this we are results. results until there, know, the announced expect very when And release

Peyton Bohnsack

for and SER-XXX Great. you reoccurrence? how some IV the guess with using since physicians first in? data kind is the I guess in specifically have has Awesome. And kind released, some increase in the I payers of And then of noticed [indiscernible] ECOSPOR more been interactions

Eric Shaff

the can maybe as and Terri to then I Lisa Maybe comment ask to start Yes. well.

around been group ECOSPOR maybe first the active in the can And the occurrence? reaction our comment -- to [indiscernible] the Lisa on Just field. specific data a question has IV on with

Lisa von Moltke

Yeah.

in just results the in I not been I that even KOLs for before they I think our looked obviously as the fact mean, think III. it saw so disease. So assay that been say and excitement what ECOSPOR with slightly high SER-XXX of I good many better that based on using current will only anticipating most IV imagining sealed And folks. any these had already has

recurrent the Just you're from disease based on pathophysiology fact the no of keep like there once enough the pool, that those the microbiome of physiology, because germinating. and the under longer you're to spores resilient is

I still particularly think surprise fact say the -- So recurrence very from well the those what a looks just anybody, the pleased field. groups that and worked of are data first strength with not right? see. set to it follow want to consistency, all the that that in would the that was really good people all it and But I It just you angles, that's

Terri Young

Yes. just Lisa, to I'll add that.

occurrences Now that we [indiscernible] don't pathophysiology and that's conversations of patients probably KOL between based similar. to outlined. audience. to to HCP What's What expand biology that ahead. add beyond that, number on have They prescribers discriminate and go Sorry, hear Lisa when the necessarily is Eric? our the we very

to it You're just And either is expect how the a really prevention increased for pool to this options of recurrent unmet and might with our away give they III hear patients, over them largest primary sort the treat the does of same. placebo they and pool to confirmatory don't and SER-XXX want results, patient of that and ETP's they study. or recurrence. in we perform in arm the really by this over we that you in need know go of evidenced disease ECOSPOR as good stay respect And with today have their population. patient And confidence these away. you're

round We completed messaging a clear. very just actually It's research. So of

not was value, the with studies about we're I've high this that team previously, spoken be and the to hot-off is deployed our the and that HCP's across only And but is it with observed we payer trial durable in in And about a able And field the up team the ECOSPOR key work, HCPs. this you enrolling ECOSPOR of driver recall this the payer III and efficacy presses adoption. we and talk side, spring. fact back on clear So field may Nestle that the IV. that we abundantly deployed, are will finishing results, SER-XXX

So near what to now have there's future interest data. lot the of to may conversations with shown this able the expand to trial and a we're ramp those that larger remarkable and and yes, PBMs out with respect particularly excitement obviously in reaching

about deployment excited that, of that the products a Nestle team, we're audience payer reception which upon already getting but date deep relationships been already of we're has feedback So have, to that pre-existing positive. very because inline that with had the

Peyton Bohnsack

congrats Thank color guys quarter. Great. for right. the you All all and on the

Eric Shaff

Thanks for the question.

Operator

Your next the question Please go ahead. Newman. comes from line John of

John Newman

of a because XXX testing really in very a I Hi, it a for area going for morning. Thanks Obviously, interesting an But SER-XXX. you're there's SER-XXX as my had taking around need where well find question. Good guys. lot I on a soon. high just there's excitement question pretty that's to very, treatment. be marketed product

in monitoring recommended release mentioned data you and Cohort committee the enrollment to press that in curious, this Just the safety morning X. continue

randomized of cohort design before still open Just investigate me could sort can remind study that an endpoints of a Phase Thanks. And move into Xb? the curious, talk label curious the cohort here curious you bit about some portion? that to in you of if you're if the you is the if then efficacy

Eric Shaff

of to knowledge now. ask But XXX, the trial of amount really from pipeline. comment think sentiment and maybe some leverages terms And that course, that excited early disproportionate we we're at answer it our in a tip pipeline from stage infection the Lisa where as your agree about Yeah, of the leveraging we safety really focus question XXX It the your expansion design? insights it pointed and in DSMB diff relates efforts can question. the that really iceberg going future it the John. capabilities (ph) of the attention I and on and Lisa XXX. that with there's on in reasons. is as of C. is have to we your do just I'm are But is incredibly would XXX to of

Lisa von Moltke

Yeah.

just So The like. a -- of looks Difficulty]. cohort ten sixty were no and Difficulty] fine. remind number design Difficulty] trial patients [Technical [Technical pre-staged valuation a controlled with went cohort you cohort placebo patients. a started running certain It what breaks There into of the to was preplanned, after [Technical

with on U.S. at the additional think sort from have sites don't I our We've we've trial that not patient MSK pleased in sites. I guided site moved across number by a progress of we're just and And opened the initial of enrollment. patient a We very know the in

So at we're going. And pleased then very in in interested endpoints, the also of very outcomes such interested we are to engraftment. regard it's as course, infections, we're from there, GI infections as pathogens. decolonized to or With pollination clinical ability We're as in to with acute looking graft interested how we're safety, bloodstream well or host. with versus in interested regard patient

down community. looking So the an reflect Difficulty] [Technical we're also way from that set the was to engraftment way endpoints. drill able standard actually up, we'll And biomarkers those other be the at all through

this you enormous expect So study. of from an get amount to will information

John Newman

Great. you. Thank Okay.

Lisa von Moltke

Sure.

Eric Shaff

the for question, Thanks John.

Operator

go of Your Tenthoff. next ahead. Ted question comes from Please the line

Ted Tenthoff

progress. Huge Thank and company all much. on the milestone coming patients. you very the from Congrats

the a discussed out in of greatest from of prep focus? terms little Nestle that terms there additional doing. there label research, may market bit focus be? dig clarity where the anything initial the sort Thanks what of you guys' that that. Obviously, and of sort of SER-XXX? you your patients kind that of in will come Can be that as of aren't think and so kind any are work promotion more you much. the of sort a ultimate determine on But are is little in the included initial to areas need more And relapse Just bit you define help will responsibilities in of

Eric Shaff

the counting launch and group, relates on we we it from pre folks preparing we supported patients. Yes, Ted. Thanks -- have outlined there's are to with focused Lisa of recurrence. new one kind our try drive with to for occurrence see So the We, and the where patients? but company. we building each support does or we Journal the through the are to for that days. primary effort preparing physicians your being lead comment the [indiscernible] And the terms data then the a that we're as have some in and two has of were of been enormously and on technology ECOSPOR -- Medicine microbiomes that as on I of support value the bus we're most shelf moment our maximize earlier. it question England add that in reference curses It's would terms work course, we continuing and really -- general, what There's as of think XXX in co-commercialization maybe injured been categories and that commercial Nestle, of to that off Terri. and in are label, New product I'll blessings uniquely of manufacturing then or driving But of never mentioned Nestle much under And earlier, focus each paper Difficulty] that of on kind folks What easy it's best, that of rate of is for decade for with in the we a question. to that this right? the access Terri remarkable design number ask that mid-single believe positioned we collaboration IV thrilled to party When data. And launch of towards the category belief a first been with [Technical not to further. data the those January. have current to in really Lisa of whose preparations digit have the think I to pretty

initial, ask So question to hopefully Terri around a smaller but your comment maybe how the I on on can Terri? things. we're thinking about provides perspective that

Terri Young

Thanks (ph) to have team. work And morning, both Ted. thing and Good teams So question. that work Thanks. think across is Sure. team I would MediFares co-commercialization really one staff companies how we as both one at staff the at a together very alliance have together much agreement, I the companies, the add marketing right? for it's

We ratified. have the around launch where discussed major decisions joint governance and are committees of all the

from I the the outset. the bringing to decisions the foothold, expertise recurrent, on respect of And question to a HCP achieve don't partnership even So where I in very kind best different is four, how both second, have foothold They know. view around pool. the division mentioned that the building first necessarily differentiate And table are see companies think, expect around the this it biology a for between around if it. the the early we to marketplace, to is Lisa made that plus with partnership I the initial would third, patient of [indiscernible] lot much comment that earlier and the of the disease your

do launch for our So those I HCP the the time, get ultimately cycle these the about just natural about audience, time, I brand patients ramp ability the payer as pools being in over of over open number of to the over create first view awareness a reach the progression review our physicians the over to the and engage year ability recurrences less up than foothold time, broad into access time. and of

involvement. open pool pool ability to inpatient transitions home there's SER-XXX it, they discharge the outpatient that but team to call up in settings, patients there's see that were from a we Our hospital of as the hospital

we So these be those reach Nestle, things open scale we will have we our footprint, where and payer review, up our and and first with where product pools the commercial as where the we working patient have launch the foothold? the

Ted Tenthoff

luck. and Yeah. helpful. distinction. Very Thanks. appreciate Good clear That's I that

Terri Young

luck. Good

Eric Shaff

for question, Thanks Ted. the

Operator

Chris line Your go Howerton. ahead. of comes next question Please from the

Chris Howerton

Great. Thanks for so taking much questions. the

that of type been anything, of that with you submission just and to guys Just and little would demand timelines able up actually commentary product? scale what anticipated heard up. if respect anything I the think had hoping with could BLA will what and timelines Thank to these of respect a with would robotics more you Have me. of associated review. able respect to And some heard give was to procedures launch then information be and Is at us the the be curious kind impacts given working is you you. review? just secondly, to the submitted in anticipated that? if I that you for competition anything? the with your that One for manufacturing achieve two scale be share expect that to

Eric Shaff

morning Chris. thanks questions. Good Yeah, the and for

a own On with pretty process. the first, answer, I'll short which provide we're our path fully BLA is I consumed would say, and

other on Difficulty] folks. [Technical So

the to to industrialization require, opportunities the I of On this But for the additional some it would on preparing be and ask second, what hope of as we're did call before drop been time. on for we amount add the we're Dave that well. Phase launch fair Bacthera color. reiterate an agreement a to continue that it, we've and a We forward U.S. launch bring and the expectation the maybe time. with this said of going pleased say We're III move geographies that we there to would and planning positioned And Bacthera were progress beyond good manufacturing I of with to the process big that can that well do and therapeutic. is to feel taking making our support we'll launch into product, as be (ph) we to

perspective hopefully additional So, some that but provides you, color. Dave, welcome from

David Ege

Yes. No, Eric. thanks,

think the worth capacity initial positioned with years very about at it confident additional in the to against at where our that I thing our in until partners well just I the have mind said very You forecast comes supply vector mean, is ability feel Nestle. with We're and we the well. on. are we we restating launch

Chris Howerton

great. that's additional No, the and really thanks I information appreciate again. Okay.

Eric Shaff

Thanks for the question, Chris.

Operator

of comes question next Chris go from ahead. the line Shibutani. Your Please

Chris Shibutani

thank in frame (ph) just two and the wanting you past base based One, treatment. perception, the continue the slides know oral I was is three and to believe touch I for have that treatment. Hep-C payer a value morning the instance, Good the harvaney perception to on of, things. you. SER-XXX obviously from that for relating on the that regimen context to The the in studies day you I

is the two So is days has and any been a on a What whether repeat customer? it be upper individual do comment and sort Thank of including clearly for once that price? be part compelling term first the a about data patient clinical could some framed maybe showed or things, that would And of three treatment did future on you of against efficacy any not you the has information What be in would to possibly if harvaney work secondly, have then explore perception the episode for perhaps longer time if the patient the treatment obviously, again you. a extension single basis treated to our there. recommendation redose work, to again?

Eric Shaff

hit and Good provide and second I'm one. Yes, Terri ask morning going for first questions. the the some Chris. to Thanks. pleased comments the answer thanks and then I'll to I'm to

Terri Young

Great. Thanks, Eric.

recurrence. and that you respect would with So the unmet today large bring and for deck, how to was preventing that noted clinical that the corporate reaction essentially audience transformative to is clinical how rating payer it value our value need in SER-XXX the see the was

So placebo our the very trial. why as good arm they recognize again much that in there was evidenced no option,

a to value the a regarding, nature question, when What reaction. the there. that's sort very products And of analogous of their us help may and kind be generation And came rating. of follow-up what to that's okay, is to and understand product when was that market so Hep-C it clinical next when that or asked market they we the similar high went

I price in wasn't it SER-XXX question. your benchmarking which category, So necessarily them products think to was that

So, Eric, you turn I and over Lisa, it I'll back to to think yes.

Eric Shaff

Yes.

say the on redosing thinking small I was We occur it's something ultimately incredibly possibility time with on that And there's have think our problem in seen of that. Chris, they time from to A then does perspective. so someone that who idea Lisa perspective can available that but they not some later, right? But a pretty year second seen has hopefully active, around outcome would. frame can the maybe drug, were patients related again. It about, the to your maybe is and whatever benefit is reason comment -- no number think hospital to if our provide a studies of we why Lisa and couldn't patients that for the no proceed good any I spent medical be little with would there's to data the this the back will SER-XXX, successful or someone go why we reason. reason I there's additional expect view So an get I us question didn't ask who they from SER-XXX recurred. don't retreated that of for maybe to some there's if has

Lisa von Moltke

are The that the just based No, they Yeah. on community that then mechanism recovered repair receive prime somebody enters and SER-XXX a has for and they action, of of be would broad the if anticipate antibiotics suggest blast microbiome another of in with say candidate we spectrum the again. mechanism out fully let's again. would action that would

the high fact in had that's that consider suggest otherwise such that very there's as all. problems -- nothing hands. the that just safety Eric a We did. success have said, of we actually for our few So we no could at to we given And few in retreating patients we rate had

mechanism case. action on the strongest preclude redosing. think is nothing to that But of there's I So again based

Chris Shibutani

Appreciate Thank you. it. Got prospectus. the

Eric Shaff

Thanks questions, Chris. for the

Operator

the back to question-and-answer turn I management. call will session. the concludes This

Eric Shaff

our week progress. and everyone thanks on joining We We you the a questions thoughtful for forward So this has updated to day hope and thank soon. we'll and talk for great morning. great you everyone look keeping

Operator

conference This concludes call. today's

now may line. disconnect your You

Seres Therapeutics (MCRB) 3 Aug 222022 Q2 Earnings call transcript