Earnings call transcript Q1 2023

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Operator

Hello. My name is Chris, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Q1 2023 Seres Therapeutics Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Instructions]. [Operator you. Thank

Investor Tanzi, may begin. Dr. Relations, Carlo you

Carlo Tanzi

you, good and morning. Thank

Eastern first release became financial AM News and section for site. Investors press company's in quarter be available this found can the X.XX of update Our and business company's XXXX the morning a results at Web the Time and

We will have SER-XXX will slides our on new our posted site accompany study that Xb also Phase be remarks. corporate reviewing we results Web and

statements, you ability of commercial therapeutics additional I'd which and for the clinical timing study we'll to modulate future results, the certain that including like our forward-looking available microbiome to the the historical debt the timing clinical commercial making VOWST, not timing remind success sales statements milestones targets other the launch, and tranches, of to and treat and receipt final studies, microbiome the of of be VOWST, ability fact. achieve data, are and of results or infection, of prevent

results differ materially. Actual may

Additionally, and update of the under any uncertainties, our filings. but today's as these represent forward-looking of We section only. to statements obligation which certain in so. recent Any our call risks to Risk Factors do discussed made the views are these on disclaim are statements today may subject statements future, SEC we

Dr. Medical and David and On Financial today's Officer; call with Henn, Officer; Moltke, prepared by Officer. Eric Arkowitz, Chief CEO; Chief Lisa remarks, Seres' President Chief I'm Shaff, joined Dr. Scientific von Matthew

Commercial available answer Chief Officer, be Technology Terri to Young, Ege, Chief questions. will Additionally, and Officer; Dave Dr. Dr. your also

pass I'll the Eric. that, And to with call

Eric Shaff

infections delighted VOWST, everyone. and adults the for following treatment as morning, VOWST formally recurrent Drug prevention is C. and were for antibiotic Administration Carlo, you, On that April difficile approved recurrent good Food of XX, the CDI. SER-XXX. in indicated known had announce Thank to we

to meaningful transform of therapeutic option the has recurrent patients. a provides the for new diff infections We and believe management VOWST opportunity C.

we label adult received, CDI, with the with recurrent with those happy very including patients all which are We includes recurrence. first a

This in we our represents is it for an modality. VOWST SER-XXX could of this diseases data. new today's of The highlighted we breadth will our think for new incredible with indications. serious making of approval be the the as and we that We encouraging review range Seres, other a believe infectious SER-XXX indicative approach moment the microbiome applications We of that and microbiome of call, technology. highly believe address therapeutic our potential are potential medical progress illustrative of is

we long-term approval With are the here. commercial Health now of alongside opportunity We our call, won't at commercialize again VOWST, all we the so product that the launch to recently information working reiterate launch our CDI Science. VOWST VOWST approval discussed and plans collaborator, recurrent Nestlé

customer-facing share short and can to I insert to However, Nestlé week. The real-time enable last have a updates. materials core been the teams meet trained on few customers starting package with them final

been eager availability, the we to expect of clinical in are extremely has reaction June. HCPs positive, the product field The in for VOWST which and profile

moment. a in number approval will heels this VOWST on DDW discuss conference, day April the are at a received morning first of Chicago medical Lisa the in live that attending XX. week following went further hub approval Nestlé excited of teams which services be commercial patient to Our and Seres activities the with and key with of across a planned The call in

in have the product for are available on teams Finally, our June. track to and prepared supply launch and we distribution remain companies across well

have first to including stories experience C. with hear and along patients from We for those firsthand are Nestlé, at with start a option and recurrence HCPs collaborators those product. thrilled, needed recurrent diff to offer VOWST as who our treatment much a patients, with all the to

also able to scale future we meet that into designed our supply VOWST, will supply continue late We XXXX, capacity. VOWST anticipated long-term be while Recipharm, our our to believe capabilities. commercialize enhancing we Bacthera collaboration collaboration entered to build a all we drug with drug contract we In scenarios. in market partner, with As in supply uptake the demand further

is proceeding collaboration remain on track. well our plans This and

VOWST working Our in the CMC ready teams XXXX produce we XXXX as an release treated anticipate and begin are drug will expected together of integrated in patients Bacthera for products to to in be expands. manner, with that number commercial

call I'd now like over to the Lisa. to pass

Lisa von Moltke

I FDA oral treatment of in infection thought therapy This is adults Eric. antibiotic difficile facilitate microbiome spore to with of of consortium reduce C. their for future restoration indicated C. of following rCDI. of the will VOWST and the bacteria risk form. Thanks, therapy infections. recurrences the approved our in recurrent a gut begin for thereby is VOWST, prevention difficile Firmicutes

of day recurrent indication adult of the original laxative the for use a GI for vowst.com. the available treatment and refrigeration following The Importantly, label days VOWST and no is full capsules in residual stored is on remove VOWST four from regimen tract. of broad requirements. received is patients. a Web straightforward VOWST population oral to the three once has a antibiotic at antibiotics packaging dosing had site

patients our placebo-controlled end of eight of at recurrence approximately study III not that two XX% approval is group week antibiotics in a X VOWST to supported ECOSPOR The Phase compared by did alone. experience the primary with demonstrated point the XX% studies;

VOWST observed XX response We weeks. and we also periods durability time, out efficacy evaluated of to longer of over

approval, a would drug point X time VOWST of to you data the approval, emergent the the supporting for review we was Phase At information. had patients additional I event and to that detailed treatment that administered or well clinical no serious events, VOWST deaths tolerated more the attributed were provided drug. and of study

to in substantial States having death. lead at threat even by is year, Now XXX,XXX least United C. serious results Disease C. healthcare a XX,XXX hospitalizations often and disease are Prevention. per and and deaths create the There as recurrences Recurrent Control difficile a infections urgent due an health infections. Centers characterized and to in that diff can for burden CDI the

prevent symptoms Patients these as frequent life. of Approximately quality such significantly have diarrhea a all conducting symptoms of lower and debilitating hospital XX% normal with that them activities patients their CDI-related from daily recurrences suffered readmission.

We the community. present VOWST as publish to educate and to medical continue work results we

These at eight randomized Digestive study. previous individuals study, weeks Meeting the At number positive X held data remained week currently Disease Annual X Phase to being Chicago, add observed the XX% free therapeutic open This difficile nearly was new of found who IV, of in Phase ECOSPOR through of III Week our XX. CDI arm that ECOSPOR prior C. we from benefit label of free results presented single were CDI data the infections. the placebo-controlled from regardless of which

clinical published vocal community New they medical Journal team rCDI include DDW to and At microbiome VOWST in await strength as meeting, excitement England data, sentiment JAMA now from as of hear Our the that of the should availability. continues is treatment a there of and that the of consideration as the ongoing data the drug broad a affairs restoration. awareness well

are tract GvHD, medical hematopoietic lack versus to Graft or earlier between infection, Moving a now which mortality of stem cell new allo-HSCT. strong is domination with our today. included Disease, Host the the undergoing diversity The presentation allogeneic and in supports GI connection literature which transplantation, in endpoints pathogen and posted the in SER-XXX of results, patients

cultivated infections oral, undergoing resulting induce tolerance prevent investigational, of an is well as infections, bloodstream GvHD, and responses reduce therapeutic as immune microbiome designed GvHD the enteric-derived particularly severe allo-HSCT. patients to to acute to incidence SER-XXX in

discussed, concept These proof as SER-XXX from The of the have of previously been by bacteria reported data supported is various administration study, exploratory in decolonization ECOSPOR genes. SER-XXX SER-XXX development including previously strong have of resulted the at shows gut X and past. pathogens, data resistance that antibiotic III Phase which conferences, updated we carrying in the

are are antibiotic Allo-HSCT patients and risk the factors, period XXX GvHD. frequently from following high acute and These and enteric-derived including are seen This the systems treatments days severely microbiomes infections chemotherapy compromised. procedure. a immune of first are numerous when the their highly disrupted events in at patient's is regimens, adverse

is of literature specifically pathogen in in The discuss, SER-XXX linked data incidence published risk and outcome. Phase will the being GI study of centers, X in downstream including As and cancer GI the tract. the designed leading pharmacology, safety number drug the the a with both Xb includes Matt drug Cohort domination to cohorts, assess microbiome U.S. to two has of run the bacteria of at these engraftment of

XX data Nine complexities course, The Cohort Cohort allogeneic through subjects SER-XXX received in transplanted data day XXX discontinuing today the SER-XXX analysis. stem unrelated results study and received patients study X drug valuable subjects to transplant. from who with administration. due day who available subjects post subsequently are patient patients XX End those from XXX included prior treatment samples was clinical of X their to microbiome one an had to further cell completed based HSCT. on

subjects. The received average or GvHD The XX regimen engraftment age Most pre-transplant. reduced all for myelodysplastic disease, a conditioning matched peripheral was cells myeloid stem Cohort majority had myeloproliferative leukemia, their in in subjects syndrome, received neoplasia most X acute years blood intensity old, as a and and donor. for from observed unrelated cell received prophylaxis. tacrolimus-based Stem most subjects was primary subjects

immunocompromised cohort Cohort group SER-XXX no open post drug. SAEs X to focused XXX deaths and be in pharmacology. HSCT. were with dosed no study tolerated the of vulnerable was determining an first patients if safely well drug during There on evaluating within on this label HSCT this population, attributed days could is

to patients, of relatively GvHD response portion incidence study. endpoints. forward ongoing look placebo-controlled X the it the Cohort around the was of learning assess infections And and to small designed we particularly severe more, number acute clinical the Given in enteric-derived of not

I results. call to pass Matt discuss will the the pharmacology to now

Matthew Henn

plays transform resistance, various preventing has we microbial that these address pathogens functional protect an the more through complications The infections potential mechanisms. and AMR. disease role you, how harbor that other or infection, in to Thank including can of from antimicrobial people microbiome Lisa. broadly gastrointestinal Gastrointestinal important pathogen microbiome

microbes that a can of negative notably harbor can state antibiotic include the pathogens, In the bacteria frequently is context antibiotics type by single in which from a in GI. abundant as impacts reduce inserts of as Domination well downstream in GI which enteric beneficial other the is resistance. domination treatment unusually allo-HSCT,

Seres in a events reported Phase by transplant on it of four undergoing centers. HSCT morning slides majority X, shown Xb being patients all supported with in the in in across released this bacterial day XXX SER-XXX events XXXX are Slide that As across domination patients [ph] gastrointestinal common observed part large in research pellet

GI and post life Graft in and study threatening are that reduced on significantly pathogens survival MSK overall to the acute This Host XX, infections Slide additional can linked research shown that by significantly domination increases transplant be with and statistically for Disease. bloodstream published have from associated are risk versus noted

as resistance, bacterial bacteria. of GI of of have and potential and reducing clinical colonization problem domination the may often the CRE, SER-XXX pathogens and was that Enterobacteriaceae harmful downstream as ESKAPE GI other that target known designed in known by pathogen the by in commonly concern, VRE, to Enterococcaceae preventing to have abundance overgrowth also specifically HSCT the patients the potentially reduce vancomycin and carbapenem of further these consequences resistance, of

partners XX infections associated both and that transplant strains and SER-XXX also targets risk and from of incorporate Seres' were bloodstream data that and elucidate Cologne MbTx MSK PK signatures and the using The can observational selected SER-XXX to and platform identify post at from with The design from of action, functional biomarkers of drug high and reduced University depleted in our GvHD. of were taxa resolution. bacterial mechanisms PD associated at insights disease

across clinical engraft incorporated that species to conducted have disease and probability has date of pathways. strong patients, in with the which understand higher from to Seres also modulation GI We had a broadly tract trials various relevant data associations to

bacterial extensive strain nearly library, strains of represented leveraging of XXX consortia screened were different bacteria that species. Lastly, our over that combinations we XXX

Disease barrier VRE included species strains literature CRE, that the pathways exhibited in epithelial and modulate vivo. functional described previously in growth strains screening to the for relevant and integrity to promote Host not and properties versus multiple of optimally species Graft immune select prevent many This that

evaluated in from the Cohort prior in its consistent context consortia showed patients with with immunocompromised in microbiome Seres expectations In Bacteria indicating the clinical present well into the in and design. bacteria activity highly microbiome magnitude was tolerated drug from profile observed GI. these therapeutics, with SER-XXX the kinetics engrafted GI the X, patients results pharmacological in HSCT SER-XXX patients' the other the of safety consistent

the a a cumulative As single occurring reference on Cohort patient's incidence families in single reported were the transplantation. pathogens the strikingly, was GI in to event the incidence XX in cell population where XX% stem in are in incidence Enterobacteriaceae, same domination Slide cumulative X. Streptococcaceae at with traumatic days in only These these observed observed MSK, of to XX% by domination ESKAPE XX, rare, post contrast of pathogens the the cohort GI and HSCT ESKAPE the Staphylococcaceae cumulative compared results Enterococcaceae, bacterial sharp through SER-XXX

It initial results from X these immune microbiome biomarker this all subject previously was to across additional which not is the domination observed with These SER-XXX Cohort notable obtaining forward transient, response confirm patients, well And that year active domination later look additional results. pharmacologically published Cohort one measures and day and that was X case X we we patient the only and Cohort tolerated HSCT. XXX were in post through events of in patients. events host from

clear observed to highly encouraging from confidence clinical support in SER-XXX. for our meaningful and achieving Cohort a These increase favorable that early have provides believe date We GI X results we data are mechanistic domination responses. the

Data patients the earlier and reported Cohort enables pharmacology as advancement is the the safety year, context of of a actively enrolling. no were rules comparator evaluation placebo Cohort stopping Board X randomized, targets this in X, of As arm. the drug and XX Safety approved and met, double-blind, X Cohort predefined Monitoring

resulting Data of clinical and further X insights, a to Graft the data and biomarkers infections, of the infections, further Cohort other of Disease biomarkers GI such mechanistic of impact on SER-XXX elucidate set obtain incidence broad extend and outcomes. versus of bloodstream from from translational the mechanisms to as clinical SER-XXX Host action will important from of activity,

SER-XXX the patients medical unmet commercial undergoing opportunities in broadly. significant Seres the both more programs and cell inform will and infection believes has needs benefit substantial. the stem data and for be SER-XXX These to specifically additional that immunomodulation transplant. potential SER-XXX address in may potential

with versus year on estimated receive Slide are in the and per nearly combined. in result to Disease. and with approximately Blood mortality nearly all with allo-HSCT to Graft Host Research International costly, infections XX, EU Marrow for to with XX,XXX Infections according As frequent the costs additional noted versus allo-HSCT substantial Graft and X,XXX in individuals U.S., Center U.S. are associated Complications complications Host and Transplant of associated half and due the database. Disease

our financials. call overview I'll that, David the turn With now to to an provide of

David Arkowitz

reiterate release so financials million first morning, The in Matt. the the here. marketable details approximately XXXX are all and Seres securities. of quarter figures the our Thanks, quarter of ended included this in equivalents first with press issued I won't XXX cash, cash

in receive With April, payment to the of million $XXX to approval FDA Nestlé. we are a VOWST milestone due from

development future XX certain activities. two facilitate in available discretion million the received we additional targets, million late announced Oaktree. each tranches entered the at VOWST achievement million we XX will secured additional million with business April, to funding available available three XX closing, potential an Oaktree's facility addition, In with as a into debt in tranches We including XXX previously in and at of million, of upon be future, sales $XXX in

million approximately outstanding to And XX net XX retired closing, debt. received million. proceeds fees at the deducting after and the XXX expenses, were us million Of approximately

our cash from result, balance at Oaktree. and was financing end million, includes a the our first forma the VOWST XXX of As the proceeds with quarter approval which approximately net milestone debt pro

losses. Nestlé profits will we launched, is VOWST sharing with and the commercial in be equally Once

milestones agreement opportunity million. have up with co-commercialization sales the XXX the per addition, to totaling In Nestlé, earn target we to

expect future, that near and their we have supply steady payments from expect meet we We of building the the to already Nestlé have produced anticipation purchases by term, and demand. launch. Nestlé pattern related in receive VOWST a of to are commercial Nestlé, in purchase inventory inventory responsible to supplying for inventory of market we the to we In been

operating be loss net From our goods cost on P&L perspective, loss of share as expense an operating section sales, VOWST in accounting XX% profit operating income based VOWST income determined we and will sold expect of party. VOWST that related marketing loss and or expenses. our or be collaboration in or sales sharing will the recognized

manufacturing no the and addition, be sheet will on expect R&D will be our that be inventory. capitalized, forward, expenses will going decline expenses balance R&D P&L, costs forward. will of recognized approval but recognized longer capitalized commercial as In our in the Because commercial now the instead costs VOWST, total with manufacturing as we our going

quarterly VOWST progress. enable additional For million quarter our future approximately commercial Furthermore, better expenses, during $XX of we financial million of key first context, understanding updates, launch XXXX metrics XX% results costs. to financial of was total VOWST plan reflected or commercialization to a provide R&D which XX manufacturing

XXXX, resources and production commercial remainder VOWST continued commercial over efforts the of our of are and supply. the the we launch Regarding prioritizing

In continue the capacity supply our opportunities. our to expansion collaboration. through term we resourcing pipeline with of in on our expand longer a protection addition, parallel, bacteria appropriately focus are we product And VOWST infection

to our As launch, support we've to partner, company in VOWST operational be to programs. to In approval expanded organization our to our our our on we well and with driving continuing pursue summary, capabilities we optimize Nestlé, cost drive and efficiencies, very ongoing development are much across commercialize much opportunities focused and are of structure. continues the of VOWST effectively positioned and preclinical

now will Eric. the back turn to call I

Eric Shaff

period and VOWST, have ever product. Thank we commercialize received for we This begin Seres for to microbiome an the you, is approval David. therapeutic, as will orally first this exciting soon administered

have progress with are new we shared we very today. the also making SER-XXX excited We with the are about data

we seen we are clinical will to hopeful forward X next data that data Cohort in and X are looking Cohort year. that We meaningful have results, mechanistic the into translate

development this other course advancing forward look progress are over of additional the information also to year. candidates providing making we We about the

talented the their responsible that approval progress made work. have we is for patients and hard advancing for close the candidates thanking team the of is to Seres and to for therapeutic like in VOWST It by need. this new I'd team that dedicated

and call questions. that, open With we to up remarks conclude will our the

Operator

[Operator Instructions]. you. Thank

question is Mark from Breidenbach first Our with Oppenheimer.

Your line is open.

Mark Breidenbach

for morning, Good our Thanks Hi. question quarter. taking and on guys. the congrats

now that First standardize the type I'm I across kind guess Cohort day you're one occurred underlying of that source infections X the or you on the like it's of any after that provide prophylaxis approaching GvHD me sites for What impact Was conditioning XXX. regimen a of and be incidence deaths causes can three graft you you And deaths? wondering following comment those European Any last enrolling questions. SER-XXX. to different the rate. in for Obviously, GvHD and for would it FDA in any for comment if were question can that me can for the you're I'm the there taking on taking if Thanks the trial. second, substantial those is clinical have viral are our FDA on approval new And on like information the VOWST. approval? curious can things And infection plans have you helpful. just things and hand, really steps on regulators involved malignancy?

Eric Shaff

morning. much. very thanks Mark, Good

Let two first your questions, the standardization, which variability, I'll Europe. deaths. talk on the is me And to about ask comment Lisa then patient the

Lisa von Moltke

Yes.

you getting, people consistency terms in of be our we're what kinds most of from the specifying of just typical both in in into able trial. GvHD terms we prophylaxis even But enrolling, in as are to of we And need what we terms come patients a that to and seeing anti-infectives. the grafts, actively of are is of getting could the results population. they're pretty kinds So are the not have see to

of other to particularly have question. fact these do able arm the in with about the be good was -- patients deaths, So able the Yes. we And complicated feel out that the pretty the fact no then on placebo question pick signals correct? regimens, that spite with be to we'll

for related So to stage. things these case, one care In disease patients progression. had their was end hospice it just

actually a progression. relapse third was aspiration And disease infection it case case, an of pneumonia a it Another an was disease result. in setting then the within

Eric Shaff

one we to Mark, the I And at the the European are just walking latter, and VOWST. on then, And would gum as of is say adept time. feel chewing which same for as we any take plans

with events other hand, on that been of the next obviously cohort alongside with has our first this VOWST the Nestlé, encouraged the we're think been our with devoted FDA incredibly energy about and will On company. Europe. by opportunity finish of focus approval line to resources towards with the Nestlé really consider But for in as XXX. of But and meaningful have the getting we steps the both we those

think base be that. to in that had approach as we conversations that our expected will the mentioned And we I another study. case run with we and to to timing Nestlé beforehand was

Mark Breidenbach

much, so and Thanks congrats Okay. again.

Eric Shaff

Thanks.

Operator

is question Joseph from next Thome Cowen. with The

line open. is Your

Joseph Thome

one the consistent in do thank our the questions. on domination? are was morning. after about know I domination pathogen what Good of think pathogen domination, this treatment, for patients Congrats data events you you cases kind just ESKAPE update ESKAPE potential SER-XXX versus important that and this? terms the taking first Maybe long-term pathogen transient. How transient of have did mentioned the you

of the terms kind in these risk, domination that? any have factors this have other Thanks. additional color pathogen two transient predisposing any And could patient to would that versus Just led [indiscernible]? patients of on

Eric Shaff

for good Thanks morning. Joe, the question.

Matt Lisa to ask start to maybe comment afterwards. me Let and

Matthew Henn

good morning. Joe, Yes,

domination being and in highly additional to patients, domination. pathogen potential risk, this ESKAPE term immunocompromised the have to durable not respect pathogen are patient advantages these in post transient mind, long versus are with HSCT. Keep So population certainly there particularly

infection. neutropenia, have at of are they they high risk While

you downstream barrier domination the those a further that more the complication. a and the and events they bacteria are, becoming the infection risk longer bloodstream the So have of greater crossing and

meaningful. So transient is the

Lisa von Moltke

two had in these could have but And with is related. that interesting be regard folks complexities the course, clinical course numbers, Yes. their again, clinical then to it we small that

we numbers. I way know more we'll when think get bigger

Joseph Thome

how in Or profit VOWST. guess do here's you terms share we're here's and on to maybe you then from how granular it I VOWST having when And sales, of sales, going quarter? much much more here's product helpful. can those how on loss That's going start forward be the profit? on is I or Perfect. to point our expect a going be here's one guess forward? you that availability and spending efforts going you're

Eric Shaff

Yes, Joe.

I can question's in metrics that from the your to ask the a -- around about past financials. the has be David of more think Terri Maybe perspective. comment we'll maybe about types talked the questions thinking I on

David Arkowitz

Yes, Joe. forward Thanks, the we're and next Yes. commercialization. that and looking of progress some as those VOWST relates understand providing share to investors operational just it analysts at help will better to We'll our metrics combination financial earnings call.

Joseph Thome

Okay. Perfect. Thank you very much.

Eric Shaff

questions, Thanks Joe. for the

Operator

next The is with from Romero question Tessa JPMorgan.

Your line is open.

Tessa Romero

morning, much our Hi. so for Thanks VOWST. taking on us Good questions. One guys. from

coming not part approval a Thanks much. a review product? could the can the before little While long just bit price has part my the finishes? around with the very we're what second payer off a process up is the exception from of you've us you you're thinking the second -- medical understand of so And via feedback follow marketplace question I heard of ago, if about early then, better if just how accessing help physicians product been

Eric Shaff

the of and first combines for key can question. in I that the to second prior really innovation questions. been for doing a going that, Terri Thanks deal morning metrics and to I'm the certainly establishing invite maybe a say access. bit we the considering announcement of that had had the to I'll further But we preempt just great to and on us after work answer approval, ask little and to Terri the value price comment. the comment announced as price

Terri Young

standpoint much the for quite the of in fortunate were Chicago Sure. Tessa. pre-launch, DDW Really reaction been question, larger the a received scale, [ph] to Thanks approval. although reactions we on the like on piece very our many we have key Congress heels because right have for much

on had important the data feedback quite Nestlé. on of I'll of began shareholders tell considerations excitement VOWST. early was to From the summer and pre-launch decision again interactions. of And work heels we've price availability was the number of did work from our expected, a factoring has And many of high there's that all regarding the the with extensive of specifically of our we the the that very high set course. KOL diligence III interest payers, HCP in The we and because that So been XXXX, it again on. and yet, into KOLs it's all what range you that which tells and the evaluate the we in work very patients of price working back receipt the for days, it's did at the isn't, ECOSPOR spot our that the to collaborators you,

very pre-launch the feedback early much pre-approval. but very the with feedback we've line will So very, expectation be my in is and received days,

Regarding the medical this what VOWST. is to not you exception process, I tell can is unique that

decision So to to the made. health can blocks understand. important market that's a PBMs different are plans approval very across upon until All coverage can and products subject the product be be evaluated and

go process patient such to prior the our voyage dissimilar authorization that too that's in very that reason during time, support process. capability a robust And of VOWST physicians a not period hub from through that's have established So services. a we

prior confident that through to support that Does they coverage made. help? being patients process we'll very So able we're and this go physicians as decisions be to

Tessa Romero

us be bit Very much of think think kind of you sense the helpful. sense you little if here, kind there? to give there more of And exception a you a be months or can the a scope process get of medical to of first commonplace XX will X trying will just in how

Terri Young

in that made. until is the Well, remains process Absolutely. coverage decision place

coverage payers to ready the sooner part until payer be interactions them team approval that is the for what deployed goal year pre-approval exactly the in ago in are a as we to before, of is, mentioned later. process I've permitted so post they're to over that do. exception made, and the determine place. timing coverage what queue decisions the process of remains And As with that decisions get that we than was rather could those coverage could immediately get in so go and those medical deployment But

Tessa Romero

so our questions. taking much Thanks Okay. for

Terri Young

Tessa. welcome, You're

Eric Shaff

the Thanks for questions.

Operator

with is question The Genuity. Canaccord from next Newman John

open. is line Your

John Newman

questions. team. morning Hi, Good for my taking and thanks

on question really, SER-XXX, a had I here. interesting So program really

reduction we're kind on, we the infections potential Just benefit study maybe curious and both you thinking about where of should be of GvHD endpoints think just reduction curious about key the more the more to the as for should when of outcomes, thinking or transplant patients? later XXX have Thanks. or if greatest for how kind the those we how in serious be things, about term longer can thinking about of

Eric Shaff

more. thanks ask the have is good I'll which morning. John, Lisa So and answer, quick for And But I'll yes. little to a bit question the expand

Lisa von Moltke

Yes.

in a infections and I to microbiomes little are first XXX as GvHD but even to be enteric-derived us heard think not really we by only where where closer the the time period that going we're window, patients' that's talk about certainly days have and well. to actual acute going their both probably anti-infectives, assaulted And you could as today focusing. been regimens chemotherapeutic procedure narrow in the HSCT be

transplant GvHD with And GvHD infections there recall the of And see so time, the those and really cases we'll severe that that within and at be intestine. looking we're to then number death GvHD, GI important the for a looking launch that the then in to refractory. and infections that are that entire see the causes are regard acute bloodstream be steroid particularly the if to infection going of And the we just occur reduction from actually in cases tract, journey.

going emphasize too think to So of be wide to we casting be terms it's going I we're important net endpoints that diffused not such it's -- understand. won't that in to to a be

caused reduction Matt we GvHD. register safety, for But enteric-derived acute severity the course, of mechanism, particularly it's bacteria with will those talked that by infections, and to regard things. organisms in about, Of

John Newman

you. Thank great. Okay,

Lisa von Moltke

Yes.

Eric Shaff

question, the for John. Thanks

Operator

The next Shibutani from question Goldman with is Sachs. Chris

open. Your is line

Stephen Sloan

driving I believe those a there's taking the remarks have for had Hi. I of This I is Thanks you course Host of Stephen it was optimizing a about question terms patients valuable efficiencies for had comment had that you focus versus anticipated questions. cost Chris. And would I that of in the SER-XXX. section if Graft any over our was one if infections what stated structure. on what patients or and on that a could believe a any David's percent those infection. be received transplant, the during other that prepared an wondering kind operational expect and in to speak on to of three would died Disease, of events.

elaborate there, of you're about, planning taking. Thank on if in you curious steps you. what terms can Just

Eric Shaff

morning. Maybe Lisa David to Stephen, Yes, then good comment I second the can with take I'll and ask the Dave. first on and

Lisa von Moltke

Yes.

and it's really So tease for to is trying critical have in have number a we this clinical small to be remarks, benchmarking events. course, reflective arm that's variables expect of prepared anticipate already the other across numbers, to arm placebo-controlled has are a there will that of mentioned, right, going as arms. We, which both will we very distributed evenly as internal we some our but out be getting these because really else somebody be stated treatment, they

put get together. we'll what so data a of have set be all once much able better sense to And that we seeing we're

looking in of been the that lack we've always really given between this and the There's sequelae to -- looking that adjacency domination, this domination clinical are fact and time events. data, the very that's perilous well we amazingly established. at each our a pretty small seeing at we're numbers, such But the about area it's we review is we clinical and again, data reminded KOLs with literature. think excited the with fact I start remain So deep

preserve able able top we advice our to that ability set And so that data to we're this as Cohort X. we're with heeding to want also sticking we information a it and line and to cohesive I'll messaging. be publish put are add when our with present also

Eric Shaff

scaled the to pieces other R&D second on. any we is the which turn been talked start remarks, Dave that not have to David, as And side. flowed one of efficiencies are to changes example, through the where take comment And prepared which are product the in we based including VOWST. with will the which can follow David support stability the that the on forward. on his in maybe the one just of about say them, post -- are comments. there where then, question, line, I'll put efficiency had inventory, approval, would aspects shelf can And the place There build we is maybe drive. that life can But I going what of Stephen, then some the ask and structural of we think up that of I

David Ege

sure. Yes,

gave really for were life the final we that as FDA pleased So intermediates, product. life, life the three-year shelf well for us good multi-year shelf our as shelf drug

along flexibility where we better way. chain in production our of and maintain and supply inventory manage that So us can lot this gives our build about a

David Arkowitz

Stephen. just would variety that, opportunities. at a I And add We're of to looking

medical outsource looking office will look bring our some savings. rationalize at that activities that. We're we're donor testing. we For Those looking to in-house a and to also facilities that close example, taking are certain meaningful generate

are examples. focused we couple just But this. of those on are very So much a

Stephen Sloan

the That's Okay. all color. Thank you for helpful. very

Eric Shaff

for questions. Thanks the

Operator

The with is Nakae next from question [Operator Keay Chardan. Instructions].

open. Your line is

Keay Nakae

about and XXX Yes. A engraftment couple of observed. you the questions

included different provide First is the domination, of degree engraftment of I'm to you in component did the what some order have the the achieved amount threshold question, consistent case then the that is to in in patients? be understand than in guess the engraftment species there's And lower other across needs is to protection. of where I Thanks. trying engraftment product?

Eric Shaff

the for Thanks question. Yes.

Let me ask to comment. Matt

Matthew Henn

questions. Sure. Thanks, Keay, for those

engraftment that. a couple important the So around points results,

expected. confirmed they drug one, So, were formulation and our as

So the patients. saw of I observation. across think the that strains that's a various majority very We different important engrafted

as consistent on expected an patterns prior was important have absolutely observation what engraftment we well. was that so And based results. with consistent would that -- were And our trial

our dosing as say strategy You asked with we're let well. consistent me -- a just and question

the that actually patient where was the confidence weakest is question where pharmacological a question. activity where And whether about drug saw this engraftment Great what whether part case we event in saw of signature. saw engraftment we domination the in of You less. domination gives us asked the the events, we was

Keay Nakae

Okay, great.

Eric Shaff

Thanks questions, for the Keay.

Operator

management I'll over closing further remarks. time. no at to any back for questions have We turn this it

Eric Shaff

soon. us great morning. Hope a that very We talk and everyone this thanks to have progress. week. you forward look great a joining We'll for much. to So updating Thanks day you on our

Operator

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

You disconnect. may now

Seres Therapeutics (MCRB) 9 May 232023 Q1 Earnings call transcript