MCRB - Earnings call transcript Q4 2019 | Seres Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Fourth Quarter Seres Therapeutics Earnings Conference Call. At this time, all participants’ lines are in a listen-only mode. After the speaker’s presentation there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference may be recorded. [Operator Instructions]

to conference like speaker to now Mr. today, would turn over the your I of Investor Head Tanzi, Carlo Relations. ahead, go Please sir.

Carlo Tanzi

Thank you Olivia and good morning everyone.

with business at Media section release results be found this press the the Investors quarter can fourth Our and the XXXX morning and and a a.m. company's update X:XX available of on became Eastern Time company's financial website.

regulatory and and we'll availability relating resources. to I'd impact statements results our of like therapeutics, forward-looking of to our promise cash and cash be the our remind making to approval, clinical of any sufficiency the studies, you fund operations, additional potential cash timing, enrollment, the equivalents that microbiome of the and of

differ may materially. results Actual

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

today's Officer. Shaff, Dr. Chief I'm Seres’ President Henn, Matt and CEO; Scientific and On by Seres' joined Eric call,

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

Eric Shaff

Thanks, substantial Seres. and in period XXXX a have progress good of beginning XXXX morning been the Carlo and for of corporate R&D everyone.

of XXXX balance Our strengthen reach to late clinical our SER-XXX substantially the initiation provide leadership, new AstraZeneca development critical include clinical with to of SER-XXX activities, and activities Seres studies, prioritization major SER-XXX stage accomplishments pipeline, sufficient new immuno-oncology, Seres company in and appointment and, of initiation of sheet a readouts. runway collaboration

validation readouts. company, is transformative the generally. including will eventful emerging therapeutic now two more for year expect that a career XXXX, XXXX and microbiome for a could rich the for With efforts, With we company an is up provide that this the success, these late field, year and stage clinical be data set

the microbiome infection. our microbes with administered an of diversity candidate, to with restructure commensal update on C. an early increase beginning in late drug difficile SER-XXX designed SER-XXX. programs is the to start stage patients I'll with recurrent

on the microbes. treatment microbiome of and increase SER-XXX that specific insights and more to spore studies clinical for depleted these confirm SER-XXX commensal designed difficile enrich translational of and in that can based firmicute preclinical restructure Pre-clinical was with reverse forming patients C. broadly is the bacteria. the depleted disease with bacteria, diversity indicated that microbiome

SER-XXX bacterial purifies is pathogens, Seres manufacturing SER-XXX fractionates process, spores, disease includes then safety the provides the Our and advantage that manufacturing critically and linked FMC our vegetative transmission. been unique potential which pathogens. have activates a and believe bacteria to associated This process which products. We to important

study clinical III X has diff on infection. SER-XXX and as data, Phase therapy from a obtained and FDA. randomized, SER-XXX with in recurrent in both placebo orphan-drug microbiome controlled is this subjects XXX now candidate designations evaluated being Based breakthrough ECOSPOR a the known C.

III are treated antibiotics ECOSPOR receive or to subjects subjects are and randomized the SER-XXX either one-to-one study qualifying to C. All infection address placebo. diff then with standard-of-care

well-defined a our C. in cytotoxin. steadfast in objective Phase diff enrolled All population using endpoint. been are patient patients commitment to III rigorous a to X in SER-XXX have completing We for positive required and test study an ECOSPOR

diff and we infection. Notably, C. prominent have several not an who active this in guidelines disease simply field for with diff patients the C. toxin is taken use by of step, the treatment to quality to that have been rigorous which data; modified We only unusual ensure high enrolling carriers C. obtain diff those of testing bacterium. infectious are the recently recommend infection

SER-XXX essential rate steps III to we The interpretable versus challenging, eight compares recurrence primary weeks who C. up we've are of placebo made stringency dosing. has the feel at ECOSPOR the taken endpoint receive study our after diff study the While valid, more generating to enrollment that in results. subjects

this who We middle to XX% SER-XXX. therapeutic study patients results benefit study, significant, of in in forward to is statistically this clinically a the now eagerly meaningful pleased look SER-XXX to over hoping report I'm enrolled. observe that obtaining received and we're In ECOSPOR III year.

our prior may clinically Based product discussions the FDA, on that registration. with single this believe pivotal we results, meaningful study with support

this suffering data represent could for depend the required. from on infection. However, the safety recurrent breakthrough be successful, data additional C. would major patients SER-XXX strength and of a diff may If

U.S. diff case drug hospital Americans reports The E. the of infection the reported death XX,XXX is needed. our of The disease that treatments limitation we SER-XXX, the case the approaches for infection were year. urgently transmitted acquired We patient led eagerly to potential FMT by of Bacteremia this a is current in highlighted coming looking are coli for are resistant C. and to by for responsible and of out including the study summer. are excited leading forward read past a months. approximately cause in each deaths published Better by

Let program, in me to turn spores is ulcerative study biologically SER-XXX from a tracts. derived an of with active pivotal, is human Xb administered orally live-drug potentially bacterial commensal now gastrointestinal derived phase healthy SER-XXX in comprised colitis. which a mild-to-moderate our patients candidate

is microbiome, inflammation. SER-XXX UC is microbiome amplifier a of impact Our objective needed with microbiome to in this first-in-class and non-immunosuppressive develop much patients. as serious a provide the microbe SER-XXX may Moreover, of therapeutic SER-XXX option in disease. that a believe associated for intended the trigger, treatment dysfunctional reduce to a we modulates metabolites that

compared for group. proof-of-concept by Xb in the eight statistically, vancomycin phase SER-XXX difference weeks Our clinical significant patients between placebo demonstrated a the rate followed remission with to study SER-XXX treated

X% remission placebo. we with with XX% versus study, a observed SER-XXX rate that In

be and and obtained clinical sets microbiome, therapeutic bacterial support the We Clear to in with bolster have found were and associated observed SER-XXX transcriptomic both remission. that also data additional administration metabolite clinical in activity. metabolites changes species

SER-XXX Based FDA, registration designed patients from phase XXX expect safety studies. of support failed Xb a ECO-RESET. two feedback profile running highly of pivotal the induction with placebo ulcerative favourable. therapy. Supported arm study Phase active ECO-RESET the that as mild-to-moderate study is are Furthermore, enrol have SER-XXX could was randomized, we we termed one study, a the by now the to Xb for prior The success SER-XXX colitis, induction who controlled, three ECO-RESET trial, on

short showed of the patients arm followed XX-weeks daily the vancomycin receive pre-treatment clinical Phase in highest In of of course a used that arm by A, rate. the remission Xb same trial regimen the

regimen followed a placebo. the patients vancomycin In arm weeks by in receive lower of SER-XXX arm as pre-treatment arm, B, the followed C, first daily by patients of eight weeks In two dose. receive

with to having the much forward top half recruitment, to continue patient move data of in ECO-RESET line very We forward we year. second and this are looking

programs. I'd like Matt SER-XXX our next to the generation pass now to call candidate our to immune-oncology development in over discuss

Matt Henn

with translational development our Thanks, designed Eric. drug rationally designed for and inhuman next SER-XXX, live ulcerative therapeutic I'll generation discovery candidate using microbiome the reverse treatment begin platform. our SER-XXX was colitis. of

streamlined Seres for therapeutic has provide clinical screening of state-of-the-art a drug therapeutic and inform data established that deep from to optimization include that --excuse candidates. our me important manufacturing. product of computational, We pharmacological expertise like the platforms targeted microbiome and believe, our human candidate's benefits properties culturing, manufacturing design our diseases in SER-XXX may that drugs utilize insights next-generation

designed that to specific, metabolites SER-XXX nominated in immune microbiome a to and integrity. of to commensal relevant the and gastrointestinal The candidate tract of UC favorably bacteria associated improve species. and anti-inflammatory bacterial have pathways epithelial defined, modify consortia the We finalized incorporates are impact SER-XXX microbiome design and barrier in

SER-XXX The our remission design of Xb phase SER-XXX and from mediated and incorporates microbiome with associated microbial endoscopic biomarkers improvement clinical insights on functional pathways study.

cell-based screening SER-XXX Our have models. disease demonstrated consortia mechanisms and in assays in vivo capacity to modulate the relevant human cellular

been addition, SER-XXX In in to bacterial the confirmed humans. species engraft have

clinical evaluate patients drug activity expect The SER-XXX safety in-house pending approvals, study in is this manufactured facility in be and and and development to activities ulcerative New GMP colitis and in to start dosing year. regulatory recently we will initiated later run Seres Zealand Australia we SER-XXX patients.

We these on-going recruitment in competition and our study countries SER-XXX our therapeutic approaches, to microbiome physician with study. have on SER-XXX minimise based interest selected substantial for

microbiome inhibitor and that candidate biologically now our signature, Moving reflect associated therapeutic focused an checkpoint therapies. with bacterial gastrointestinal bacteria administered comprising the orally to to is SER-XXX derived microbiome SER-XXX work. response live oncology

we MD randomized XX at Center, with our patients either with Xb in subjects receive Immunotherapy and collaboration ratio phase for enroll study In randomized nivolumab; are Cancer a Institute All placebo-controlled melanoma. and the to therapy, Cancer metastatic Parker to continue anti-PD-X placebo. an Anderson X:X or approved FDA SER-XXX

clinical evaluate response The and study safety, of signatures biomarkers microbiome response. response, and will various potential including

biomarkers. immunological and activity tumor will pharmacodynamic potential other specifically We to biopsies evaluate examine

We expect this of year. in phase report to Xb the results second study half preliminary XXX

understanding expertise clinical The to of research We research therapies further progress extensive also to related response. oncology our manufacturing with potential oncology checkpoint continue drug work AstraZeneca inhibitor discovery the immuno experience to of with our improve collaboration. combined microbiome Seres AstraZeneca’s the microbiome make and

a expect for We extend as of our understanding collaboration new therapies to the therapeutic microbiome promise approach cancer. the of

In addition, Seres million collaboration. in and with thirds financial obtained, of reimburses have been disagreement all to which already the also two activities provides AstraZeneca support, related research XX

Eric. the to pass back now I'll call

Eric Shaff

Thanks, Matt.

for Turning corporate reported loss early year. the $XX.X loss of now the to a last XXXX efforts reduction the in result an a the is $XX.X XXXX. for our million net net to million refocusing Seres The XXXX of period fourth of overview of compared financials. as a of spend same in quarter implemented

of and the development primarily expenses, The microbiome therapeutics company's fourth platform. quarter development personnel net expenses driven loss on-going clinical and was by

Seres $XX.X $XX.X with sequentially equivalents, the approximately quarter. we ended the fourth million end in for an of and million cash increase that from the the quarter, cash reported third

AstraZeneca announced our received tranche on-going million included the that previously from as Our $XX cash the debt of closing upon of the million fourth position as to three we immune-oncology related agreement. of our payments $X.X quarter agreements second first well

into resources Nestlé future quarter to part excluding to expenditure runway Seres million associated entitled a SER-XXX capital X development Health cash flows cash our net company's or Collaboration. does Phase XXXX. business operating not potential fund incoming second The milestone cash would $XX as of the payment that requirements, from payments, Science This include expected be expenses of milestone are activities and

mention opening no future we CMO chief have his questions, officer on the him medical to decided the position. wish Before endeavors. up change company, our and make I Seres to call your is the with prior will Kevin best we to a Horgan, that longer

entering today, As clinical we late discussed regulatory an stage important interactions. eventful readouts Seres and period is with

in search today operations, clinical CMO, team clinical today. a strong provide is a regulatory executing effectively in place candidates have expert dialogue development to have programs. with underway fortunate several we are our and on-going medical, experienced professionals who strong on with and will are that for been leadership, We A

let's open Operator, line-up the for questions.

Operator

first Cowen. the Chris question Our of Instructions] line coming Shibutani with from [Operator

Your line is open.

Pam Barrett

on Barrett update. Pam is Chris. This guys. for for the Hi Thanks

few We questions. have a

just you thoughts would in what where should provide or some be the you before can data, Do you mentioned on Any format, it’s provide you positive investors whether a expect first will call? release can the there in great? release provide numbers? a expect First, negative, of terms you SER-XXX help release press

Eric Shaff

question. Pam. for Yes, Thanks the

a have of as top relates number certain We data. to it clinical precedents line disclosing

it's that precedents. likely those think I we would that follow

not possible. of a be endpoints as alongside or the the have out data have I support is was I clinical of but robust think topline clinical we working of it just that of you get constraints, analysis blinding whether that we quickly it because analysis would reasonably point would as set will would sets positive both unlikely course, to of negative. microbiome

Pam Barrett

this full about quarter? Got provide to more hearing Are it. question planning And you since begin half, actually maybe about we're that. there? patients dosing Can timelines you SER-XXX this a

Eric Shaff

except Yes this that excited clinical. we begun I we clinical are specificity moving say we've about operations. will provided really into initiated program. We've forward Pam, haven't that

and design manufacture have platform of our sourced that we for SER-XXX our can study some some than Later we're specifically program, I of XXX of platform. think on our benefit in that that first to about are excited but excited illustrative -- Matt program. certainly and the we biologically the I this comment the with have expect we're between to reasons more The taken we applied the from in, I why the of the that. maybe patient learning’s with that, is guided specificity just been or where our XXX year, we about do XXX we've and synthetic XXXX. Xb synergy in haven't

Matt Henn

noted, of the modulating we as have are insights and a pharmacological well in-human EC leverage candidate Yes, epithelial program too include we've exciting that different innate important I various barrier to And effectively the Eric design response disease. optimize clinical been feel which specific that of these of and the able into is as a improving context been very SER-XXX integrity, immune set able for very identified where this adaptive very in clinic. as we our on to moving microbiome from as therapeutic in pathways rapidly we've properties,

Pam Barrett

you very Got it. Thank much.

Eric Shaff

question, Thanks for Pam. the

Operator

our question And next Terence with line of from Sachs. Flynn the Goldman coming

open. is line Your

Unidentified Analyst

you this Hudson question. Missy for the [ph] on Hi, for is Terrence. Thank taking

the For you're powering mind you that of when arm -- phase SER-XXX, would Xb and control study? of such the trial --

Eric Shaff

Missy, that well were provided in mean as study, the those efficacy opportunity, in subjects about Yes, tremendous Xb a that in not there's on the highly excited have a this unmet really safety most the we the moving as by specific the on and the larger we of I XXX commercial results based space study. the we're need, signals the question power. a to We terms safety. efficacy we and approximately And significantly saw. both opportunity we of that, the will forward looking with and of think say medical this based And encouraged that replicate in we're results guidance

of that think address in those can As you or are the carry could solution and on development SER-XXX that market immunosuppression, know with dimensions. a effects number agents including we today, meaningful the meaningfully side are a

excited remind in FDA pleased execution was one be from our terms really in feedback I'm could you that study very about of that I'll of of studies, terms and our two in this we’ve enrollments. month-to-date We're received largest pivotal mode moving enrollment. the February forward. that we're

So this we forward second receiving to half the results line those top of look year. in

Operator

with comes question from Oppenheimer. The line Mark of Breidenbach next the

Your open. is line

Mark Breidenbach

be? at then of the Thanks ones just you you potential your guys. And when next up Two us could scheduled from for FDA three registration quick SER-XXX kind Thanks. for confirmatory And the have envision follow or a is requirements maybe I've meeting a taking questions. if would know a BLA? file for Henn? got morning with Maybe the good us. Hey, what Matt discuss to let directed do sufficient to that trial any goes for

Eric Shaff

Yes. for Mark the question. thanks

Our meeting and would this results the is you is top of X as the we that designated program line expectation FDA. an breakthrough by have Phase end the following I'll remind this year,

be this quickly that therapy So as making getting in the as diligence focused we sure possible. we're of as as will patients

as we'll we're to to that over recently significant that get the possible. November as FDA death, think this some that consequence as convened to the in I there's to to the the for of summer, know, provide highlighted safety just FDA and fact speak the the the a dimensions get need that of that XXX have patient of try deaths in space a solution moving aggressively meeting you a hoping happened including of quickly so, in patients was as like to with be been that patient front maybe what

you’ve for And question Mark? had second the Matt,

Mark Breidenbach

Yes.

improve if criteria overtime our confidence you confidence to your the last SER-XXX? strength products evolved Matt, I’m wondering your comment improve on how So selection with to reflecting back SER-XXX, could rationally have so defined just or

Matt Henn

Yes absolutely. sure,

Thanks. So question, it's Mark. great

of that changes the of inclusion our has into human the we've to learnings in to the the designed first able dynamics different was of SER-XXX. engraft given go which been functional composition how clinic. SER-XXX in from and the into which patient So, there we to terms grafted and the with timing XXX various subjects, have that those fundamental saw and bacteria launch incorporated been dynamics of as all our design inhuman the the since data original and leverage respect which into incorporating those in dynamics actually the in have the dose, of gains year And well over various our that were our of of properties clinic, subjects, as design key and been those that datasets rationally engraft and which populations, conveyed the primarily acquired one and different data we XXX they from specifically

assays designed that then and on advanced it believe, itself. pharmacological course vivo these to robust learning. various we a assays, of have of properties the that properties strains have ex-vivo we based in allow in those composition screening have And based in our composition human we that So we that confirm us the will cell achieve functional human to do, have the

product piece, add have also manufacturing to that well. advance advanced our of these clinic, continued the competitions moving been the on side. learnings respect since XXX as in-house And capabilities last We've the last the XXX the and is design and into I'd manufacturing to into with manufacturing and those of the incorporated XXX have

Mark Breidenbach

Okay, taking perfect. questions. Thanks for the

Operator

Our of next Canaccord. John Newman from question coming with the line

is line Your open.

John Newman

curious recurrence progress if on taking as solely X XXX. cytotoxin be Thanks guys, based my just study. if how include and wondering C. the positive question, it with to congrats the ECOSPOR defining for are morning. symptoms diff or Hi need recurrence I'm would just phase good I'm you in will a on well?

Eric Shaff

morning the not incremental same it's additional be the the based but occurrence cytotoxin, an have and both, for And that have good as phase have an inclusion finish is strongly we using of one time, John, interpretable and requiring place Yes as you you not both a And possible but headwinds to question. from that calling a that assay the feel presentation will necessary, we It's as experienced key is on first X study. the that symptomatic we've enrolment, as thanks you're for taken time at strongly learnings the well, insufficient. to I the in that taken result feel return -- dataset. in that the think study if cytotoxin resources then we of may but there

will cytotoxin move interpretable the dataset, allowed a that of culminate in really in we're having be use know, that do study terms clear forward. strongly to to you So we a differentiator believe key

John Newman

sense have curious, what look with fidaxomicin the to if or just study. any as before like you that And great. were treated into between patients coming breakdown the might vancomycin Hey,

as will you the it a be about might XX:XX or little other? more bit you whether if curious get to or sense one any Just have whether

Eric Shaff

possible we part some But I of support think provided done might that John, beforehand. date. not that or it. it's that that we've the that analysis have would some result don't to And as level Yes topline of specificity we include of analysis

John Newman

you. Thank Great. Okay.

Eric Shaff

for Thanks questions, the John.

Operator

And from [Indiscernible] line the open. line coming of our is next question Your

Unidentified Analyst

Hi, it’s my [Indiscernible]. taking for Thanks call.

pandemic obviously data the you look and of nature have path you C. really comment can mean any like say recruitment check-in did important this secondly, conversations what clinical others me, market would But I'm if because aspects appreciated? are good, color concerns, or forward on past to in asking Just your path said subsequently data any might can of then and could a an terms sensitive sets any question the data, you say on faster but a good February since a And year, be diff?. the was to in with know depends of lot I pandemic? question, and you would and the quick be you UC outright your only more asking of that this than timelines what regulators. in was

Eric Shaff

Yes.

or We deactivate that, like interesting asked been in about What the good which don't that our some ability I So other I'll start very Maybe others. actually of execute ask if questions. approach it’s the the We approach. clinical our precautions the in safety, our it's We countries, for you it's Boller think in because happened at of you we'll we think insufficient we on and that or we any ask Matt second everybody's And that the that for on on but is particular, – process, coronavirus. necessary patient and about as China clinical it and think taking donor know the maybe feel our But you and we're but this, based is relates question. mind. differentiated, maybe that back about question, have have studies, of operations can supplies leading second which of death. summer since as the one transmission and Italy now pathogens is to steps the -- thanks are comment your I'll and to end over our studies. I whether first, business selection to certainly to safety, company the response have say [ph] in intended XXX with strongly if to believe you that manufacturing the to believe the study our microbiome then the and pathogen patient come all really our

Matt Henn

Sure.

Eric actually of such in bacterial SER-XXX our process patients as identified depleted and So with products are have we pathogens, as we that manufacturing the viruses. which dysbiosis. clearance undergoes the rigorous of the as process, And C. data And including spores difficile manufacturing specific a program coronavirus. isolates the said, pathogens such early demonstrate that from clearance that days inactivates have

Eric Shaff

combined I Yes. Boller in the present think And on correlated have have to analysis XXX supportive is might we we terms of and in results [ph] XXX, before topline with but question have that then do think, microbiome expect been results I are rigorous the in first the top your past. on clinical Q&A, that with the earlier line data mentioned this

lag the a doing course, before Of work and time when blinding study. we can that between begin there's

course for part for moving the expect stage learning XXX, of also the about results we forward new But space. But this is and really leave. to think commercial in the of in the picture as So clinical XXX. analysis we towards microbiome do late we as move

we will clinically these for looking significant studies say, we be are both would of that I lastly the benchmark at. just and results statistically So, that significant, in look a that,

Unidentified Analyst

Great. Thanks.

Operator

now any management showing I to like call would I'm back closing further questions. turn the for remarks. to not

Eric Shaff

Have great and Seres investors interest Thanks later Conference continued will the the closing, today, be at meeting we operator. much. week. to presenting want that you do forward Therapeutics. have events. you to in a And in and your will thank we look mention very I at Thank for great a Catlin day

Operator

your our participation. conclude for you gentlemen, conference today. for Thank and that Ladies does

disconnect. may all You day. Good

Seres Therapeutics (MCRB) 2 Mar 202019 Q4 Earnings call transcript