MCRB - Earnings call transcript Q1 2020 | Seres Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Seres Therapeutics Q1 Earnings Conference Call. At this time all participants are in a listen mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I must advice you that this conference is being recorded today May 7, 2020.

I would now like to hand the conference over to your speaker for today, Dr. Relations. Investor of Tanzi Carlo Carlo, please ahead. go

Carlo Tanzi

Thank and good morning. you,

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

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

may materially. differ resources Additional

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

call, today's von Matt Officer. Shaff, Scientific I'm and Officer; Chief Henn, President On Chief Eric Medical Moltke, CEO; and Lisa joined by Seres'

the pass call Eric. I'll that, With to

Eric Shaff

Carlo, morning, everyone. Thanks, and good

our the therapeutics During years, been with has hard platform. advance several a modality treatment Seres to new working last microbiome

will the modality We clearly treatment potential the clinical These for to that serious provide where definitive period expect We this the positive entering help therapeutics infection, data multiple potential the III diff are have diseases. SER-XXX demonstrate and for now microbiome approach. across a will has study highlight validation results, our Phase to study obtain to believe upcoming we from important clinical results. that including microbiome time arrived new for C. of

rest an has on to of impact it as on Seres have society. continues COVID-XX the

our changes aspects our that monitoring closely to operations impact and necessary our clinical safe. to we and are those We remain are studies continue, in business ensure making and the employees our involved of our that to all business, the

our of and their ongoing, administrative made activity work remain modifications Seres' offices, outside with manufacturing safety. R&D and continue employees employee laboratory prioritize that

protocols, at completed COVID-XX has Amidst are how forward the pipeline the pandemic. facility example, adapted run we we advancing an last SER-XXX despite fill have continue the a moving to we our Cambridge we successfully and changed, As business complexity associated and pleased week. Overall, work while our with

immediate focus Seres' is SER-XXX our and priority program. on

ahead We data ECOSPOR III and on we have year. SER-XXX month, external forward readout, III investor now SER-XXX the reporting this and expert this of recently are management in eagerly host enrollment the of completed and matter Seres' line event. top Later Phase of our to results an SER-XXX looking middle XX March study, will subject

a need the C. We of deeper treatment for diff the approaches. plan new discussion infection, to effective burden provide and safe and of discuss

study change Phase and ongoing III also treatment C. We diff. SER-XXX the potential the fundamentally to will of review the

Millennium recently biopharma We career joined Officer. Sanofi Lisa Alkermes, the Chief Genzyme, company including prominent Dr. at companies, extensive Lisa welcomed von an clinical Medical teams Moltke leading and our after Takeda. as

have very happy Lisa onboard. to We are

call to programs. I'll review our now the pass her clinical to

Lisa von Moltke

is this and an company. me be the SER-XXX, of to definitely joining update an time with start I'll exciting Eric. Thanks, for

As to for prepare Eric completed enrollment, mentioned, the and pending readout. team our study is working the clinical has hard

the C. an of risk limitations: Antibiotics, difficile Our acute important effective for program meaningfully leave done microbiome. treatment at aims patients have future for disease treating they because not recurrences, address ultimately available the this the infection, to to C. SER-XXX options Today's difficile improve recurrent debilitating damage infection. while do treatments in

Open this evidence studied we, field, Forum FMT, as enforcement peer-reviewed all Infectious widely paper published known transplant, FMT, recently the used difficile C. for microbiota topic available and experts Diseases. with on a We've is in fecal also supporting in clinical leading policy. discretion the journal infection FDA under along recurrent closely Unapproved an

limited In amounts degree data methods supporting clinical small open-label well been have FMT administered. safety FMT established. been not and of the the product summary, FMT inconsistent The designs have clinical and and efficacy the by of of of size, trial

a we the don't of efficacy adequate result, degree an understanding of FMT. have of simply As

Furthermore, questions rigorously we risk evidence this clinical the new, of of and are We Phase approach. FDA-approved as availability III through such serious trial, serious treatments for enable will SER-XXX disease. studies, about there ongoing disease the believe potentially clinical are definitive of transmission this that infectious conducted and well-characterized our provide

an to C. our to are address drug on has been understanding in prevent disruptions received specifically candidate microbiome these C. recurrent administered the designed that designed and orally the microbiome to observed risk restructure difficile a deficiencies. recurrence. of was infection. is based individuals SER-XXX difficile designed the SER-XXX at SER-XXX

SER-XXX provides purifies process bacteria that spores, fractionates been unique our as important disease safety vegetative SER-XXX bacterial This that manufacturing process like to and advantage our transmission, Now potential believe many pathogens. Coli, SARS-CoV-X. a and includes and linked We viruses manufacturing our E. FMT-associated such and inactivates have critically products. to drug-resistant pathogens

orphan evaluated subjects therapy SER-XXX placebo-controlled antibiotics the clinical and a on We drug both in have we data, address or diff receive Based FDA. to infection. C. randomized III and Phase study then diff subjects III SER-XXX recurrent All from XXX and patients with infection, designations placebo. is subjects. one-to-one study care with obtained with the standard are in microbiome treated breakthrough enrollment ECOSPOR C. are now randomized SER-XXX to completed either of being qualifying

C. ECOSPOR required III are enrolled diff patients All for to cytotoxin. positive test in

taken rigorous on-study those recurrences. The infection, C. assay difficile used step will also with the bacterium. simply we are to confirm We patients ensure of C. carriers only cytotoxin not diff be to have active who this have that enrolled and an

those recurrence to in on compared We a compelling to III receive endpoint compares obtain primary showing aim who versus received dosing. placebo the that diff who placebo. meaningfully clinically C. of SER-XXX results, rate ECOSPOR to eight The patients SER-XXX up rate patients weeks after at lower recurrence have

Seres' thus far. safety data In we've with to addition, we a all clinical observe favorable hope seen microbiomes profile as

on registration. we date, discussions that obtain support III compelling believe results, to ECOSPOR if we the Based SER-XXX study may FDA product

data strength the and data may the additional safety However, depend of required. this on be would

clinical to working lock for prepare analysis results study Our summer. this database the is and of team

has progress steady, week and end point. still to eight three been the patients need only achieve Operational

and conducting data study on been are analysis quality basis, have of for We ongoing and an control lock results. prepared data and the we study well

with other conditions. note, of so that personal a treatment exciting patients data on much approach disease, awaiting as as holds potential an pertaining with the promise Now serious it an to be is such and well intractable for to this

IIb clinically active ulcerative SER-XXX human is mild SER-XXX with tract. moderate, comprised study derived turn me let which from is bacterial program, healthy gastrointestinal candidate, to patients to commensal Now, our spores in the orally-administered colitis. of derived biologically ongoing an an Phase drug

Our a UC objective microbiome to modulates that therapeutic microbiome develop SER-XXX is patients. first-in-class the microbiome with metabolites in associated and

and reduce impact the moderate failed enroll To disease. randomized X-arm Moreover, a may that a remind XXX microbiome for dysfunctional non-immunosuppressive to this XXX treatment was who of prior much trigger designed is colitis, active, ECO-RESET Phase study mild amplifier have to the therapy. believe intended a we to that SER-XXX serious with option IIb as of is SER-XXX ulcerative you, placebo-controlled inflammation. patients provide trial induction a needed

B, Ib was patients vancomycin the course of A, placebo. two the used the followed of the that Phase vancomycin a C, the remission XX highest used Arm Arm arm Arm daily In X of of trial In receive by A, weeks regimen preconditioning same dose. of rate. receive regimen in received preconditioning, patients by patients clinical followed lower weeks in SER-XXX followed same weeks by a short showed In that Arm daily

previously halted multiple is currently based has Phase patient the impacted approximately Phase had XX% enrolled SER-XXX reported, enrolling and on Enrollment to studies, clinical procedures. sites original we COVID-XX As the study pandemic, XXX an IIb on impact COVID-XX have including the other by pandemic clinical target. nonessential continues endoscopies IIb the be The SER-XXX adversely medical and trial. our

We continue light in for various execution evaluate the to options situation. of study

is profile, further a clear of that to on to data-driven high-quality, clinically provides allows drug's obtain us make set Our data a development. overall clinical decision and meaningful a assessment the goal

remains continue to open, enroll working ECO-RESET patients. and we

team and clinical to at support providing data clinical capture. Our mitigation implemented maintaining forward has sites, regarding aimed of number flexibility strategies increased a additional clinical including progress,

continue including goals a also consistent design with obtaining our clinically trials evaluate to of overarching modifications, potential set expeditiously. various We data options, high-quality, meaningful

enroll and targeting portfolio. Ib microbiome our to increase an Immunotherapy is Cancer for MD with to continue we in With study orally immunotherapy. immunotherapy inhibitor outcomes. biologically microbiome Anderson Center we oncology derived placebo-controlled SER-XXX SER-XXX, The SER-XXX. Parker of a collaboration Cancer In checkpoint randomized, improvement in inhibitor efficacy Institute and therapeutic associated signature Phase of candidate, SER-XXX are to the patient in moving an response of Now administered bacteria reflective checkpoint with comprising

an patients randomized The either nivolumab, potential study study biomarkers safety, placebo. activity including patients and slowed anti-PD-X clinical microbiome FDA-approved pharmacodynamic biomarkers. the to SER-XXX biopsies our And will assessing metastatic COVID-XX response, plan plan. to potential The at are other ratio changes but of to enrollment. immunologic open, therapy, various to melanoma. study of All and designed evaluate remains signatures with was with examine a or SER-XXX and evaluate XX we, response. to potential response are enroll tumor The X:X We collaborators, study along received has

over hand Now, call will I the to Matt.

Matthew Henn

of designed fermented disease inflammatory colitis. candidate microbiome begin ulcerative next-generation I'll the programs. our therapeutic our with for Lisa. treatment Thanks, is rationally SER-XXX

like development reverse SER-XXX Seres' provide in-human pharmacological may properties SER-XXX streamlined powerful and drug drugs was discovery Next-generation translation, platform. optimized including designed benefits, important using manufacturing. and

manufacturing. regarding We have analysis, expertise and functional deep developed culturing, screening computational

our our by integrates and driven disease insights approach targets of from trial of Our technology therapeutic the and our own the data. from and clinical data combined druggable research candidates. insights design development in-human microbiome emerging These identification have

improve bacteria track integrity is associated and colitis. microbiome order of the ulcerative metabolites consortium modulate patients in to anti-inflammatory designed immune barrier The pathways in epithelial microbe gastrointestinal and with SER-XXX modify in in to the

to an both candidate been ever technological vegetative. product important form advanced bacteria forward. novel is It and includes colon. formulation in in to platform. and enterically delivered using to delivery achievement. several using spore coded fermentation, move is technology innovations, able SER-XXX comprised designed pleased of we as or non-spore our produced have that release is as be manufacturing first well this spore non-spore form we This strains and fermented Notably, the this requires product formulation And in candidate strain-delivered are

We we patients and run continue a Australia start regulatory working patients progress approvals, in New initiate will study to with SER-XXX Ib this clinical pending Zealand, The year. Phase to ulcerative and to colitis. expect make in be study later

disease designed now an to It in immunology. immuno-compromised and microbiome is on SER-XXX. candidate graft-versus-host move Moving we allogenic cell delivered, our hematopoietic mortality due have SER-XXX transplantation. orally patients development. to infectious forward including toward designed decided therapeutic disease infections, stem to to receiving patients, builds fermented clinical rationally in SER-XXX, that bacteremia, expertise gastrointestinal and prevent

Since increasingly clinical SER-XXX the models human inception cell-based data vivo forward. candidate advancing program's based product on support and assays, compelling the disease in data

transplant patient Somatic Cancer data a clear stem Center, outcomes. clinical from at our gastrointestinal cell Kettering Memorial collaborators microbiome and demonstrates relationship between the Sloan

clinical the to provide will cell We transplant insight in SER-XXX outcomes expect program that into stem microbiome improve for therapeutics the potential patients.

clinical also further with patients, understanding study immuno-compromised in individuals provides Phase Kettering. The meaningful for of the to multidrug-resistant financial bloodstream our with potential year CARB-X And collaboration treat through is the support We enterobacteriaceae. Ib Memorial technology such advance program enterococci, and Phase and a plan by infected broadly including later as in our a to Ib carbapenem-resistant Vancomycin-resistant this grant into that in Sloan bacteria, operational more program supported development. SER-XXX infections

I'll Eric. to now the call pass back

Eric Shaff

Matt. Thanks,

XXXX, $XX.X the now compared a period for net loss of loss a to as of in financials. first Turning XXXX. reported million of to recent $XX.X of for an million quarter the our Seres net overview same

of loss therapeutics expenses, microbiome first and personnel platform. by development and the The ongoing quarter driven net clinical primarily was expenses company's development

first quarter revenue $X.X with Health inclusive million Science was loss collaboration in the of associated net and recognized Nestlé with company's primarily The AstraZeneca.

file later press out in as XX-Q Additional this that as financial intend put quarter our be found today. that morning can well we release the to we regarding information our

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

questions. We the ahead. results the are forward Positive clinical late-stage Seres as therapeutics all field. taking fundamentally your period could very excited to well transform We about look microbiome as

let's the please open now line. Operator, up

Operator

line the from first Chris question Your Instructions] [Operator of Shibutani comes with Cowen.

Chris Shibutani

context be registration safety Can release the about and for included may concerns in share may some whether potential the potential suitable required? shared of required, COVID-XX to kind product you mention talk anticipate any considered particularly XXX additional be FMT. data little additional to you would morning's for and of this what able Can about a around reminders FDA's more of be attentiveness with safety bit Are of us data this? you of

as particular, reasonable inactivation is work? of are you broadly add already something of the of regards In just kind to would to demonstrating of that be in speaking, already the lines? proof anticipating be safety, contemplate? is time doing? And that you And that that that anything information Or can your additional it maybe other some words, it COVID-XX,

Eric Shaff

just I've line was first missed I think your of got the it. of But that Chris. the question. Yes, don't if yours. or I I gist part my know

start don't it completely, come back to comment. me can let I'm ask if it. answer to it. going Matt to So, we we And

up study. the benchmarks results provided steps single of FDA statistically safety, terms right. when that and would redesigned a top where discussions in in with we pivotal So, would the we the them around engage what of that for we year, noted may next of middle have And continued with remember the discussions we the in terms note this to in provide you end study, line in that

my And some that's has passed, to I field in would the say the as in time playing it relates that in safety. sense changed mind,

the that a that FMT. was FDA in about in additional that and warning deaths seen summer death. And a recently, from potential over The as patient the noted, the through I stool, think as November meeting COVID safety Chris, March, the right. of of FDA held then we've consequence issues because transmission First, earlier noted most of happened you

of the that believe is taken. because taken steps our differentiated that talked for time. we've and inactivation that always about We safety We've process approach CMC we've our some

because safety of point screening of think, where do clear. tipping these COVID safety, most but that maybe I unfortunate steps events that. aligned example with more But consistent, patient that safety, and around environment we the it's the us putting is most donor of It's approach general that is COVID, reactive that necessary perhaps the is now and think becoming think insufficient, we is I safety the those and sensitivity is inherently great think our inactivation right? and the differentiation a to

XXth, FDA have with our discussions around We press in in we approach. been we in have put We with our the the that noted discussions release that out on FDA. been March

back is I FDA Maybe can first FDA so and I Our results the plays top thereafter. we're and Obviously, something. all out, I the see. us different your from this on of view part the missed ask line the we'll right to know engaging can Matt question, we achieving how that come considers with FMT. comment, we Chris, miss if focused And then

Matthew Henn

Eric donor in believe the the and think from as will benefit alone points. that to reported results infections, time. vegetative origin that ability one those this given X of to point I SER-XXX screening fundamentally reports knock fractionates unknown at has spores and our which well FMT. potential being that various process that emphasize be the removing bacteria of the factor back insufficient, on agents such various as component, as view active isolating I is a and all I the can FDA importantly, mean, lead spores-forming manufacturing other in Yes, viruses that is those to And hit factors, the we that bacteria, different key is the Chris. the from

the purifies for those threats. ethanol and spores, remove that very product to safety process our So is selective

Chris Shibutani

just potentially if original quickly the trial? X-Arm aiming many the as you study the to. remind helpful. you would patients, to that's XXX are headwinds that And had you've terms can where delayed? are to No, have you on Great. you of the of in hoped doing continue and keep readout where that XXX, then can you at the that protocol just I follow-up It line results that of been pace unsurprisingly, have relative COVID-XX if just top Is us patients some conducting thinking for with sounds stage that you're

that patient things some modify to is designed within smaller this track context Or with numbers? prioritizing Talk the leeway keep study us and there in in perhaps you're how we're that on protocol to currently? adjusting

Eric Shaff

thanks Yes. question. Chris, for the

provide ask and to commentary. Let Lisa me then to I'm her and in start, going chime

impacted endoscopies, been pandemic shut it our that's procedures, endoscopies trial have trial certainly have our academic typically, of deemed down we to offering said, nonessential to of large centers. more relates sites, and availability the as we And sites SER-XXX, the a it specifically by right. As as number relates the

smaller have GI-focused do that We to be open. practices continue

the continue in continue So we and to but enroll, certainly the to same not where earlier we we screen rate at were year.

of is we now So, and where are a Chris, there's different at play. evaluating, dimensions number

As pivotal you IIb, X that time important. availability FDA, we're all data, currently of different it the course, And studies, is analysis were together told about remember, that But scenario of into of are the number X continues. of a be and thinking could that by we the that's analyses underway. of coming also

it that. that endoscopies not to but world necessarily gets to state quickly Obviously, back it see on where a it as how little starting more daylight to the in some available. are of the freely of was, a And bit depends state we're relates

analysis continues. the So,

We But study study, is arms, subjects microbiome, had it. say Lisa, about can we care X% enrolled no what matter have the than about already this significantly you as with have I Ib how where X-arm get Ib. had we're both choice thinking from are we we in being. will anything more X we're quality may clinical today in that and that add confident a ends up that will I where the data that's to sets, we missed? the we and data quality, compared

Lisa von Moltke

Yes. help No. the them find I a we're with lot to of and and of new mean, activities support doing sites complete I think, in things as lots ways activities. you work parallel, noted, to their their

potential -- us absolutely we indication to like, are kind what those We a drug landscape. would to that also again, up the starting designs is dynamic timely said, set got looking of have goal And a of what week gives we've is at its fashion. for open in of that this seen a Florida, example, with clear that medical and trial we're a Eric as look data this some even sites. we've need And

And real so in this of we parallel really a are going time. be in to doing assessing and lot

Chris Shibutani

Great. to understand XX line everyone those same midyear. look Thanks. results page to the the May to help on We forward event get top

Operator

And Sachs. Terence your comes with Flynn question Goldman next from

Melissa Hilton

you can for about you the Thanks on XXX midyear it to Hi. any question. timing? With This to expect early conversations reasonable more be June? if taking any will respect And at think position Terence. Is data, you support Missy if in require to that will is additional FDA? do it for that with point, data the the approval in or be the a specific disclose the will

Eric Shaff

guiding are midyear. to We

and to we the guided have guide We midyear. will continue

put in sites work And liaison be -- been not and position. this us That be hard privileged the doesn't important for that. there's a enrollment, considerable our has with that pandemic given group time result done at in a data, think been KOLs. We're grateful with this I critically this as deliver has we're mean an finalizing that cleaning done on amount we've PIs clinical to and that needs company, of to data, line position incredibly top very accessing to able plan. on to work unprecedented and

guide and But a lot now between So, to continue to then. we there's to will midyear. do

as and next on breakthrough and to engagement to look is think it said, the this orphan-designated really As program, giving we patients results quickly top possible. I seeing we relates that the with focused And this afterwards. reiterate time today, a line then to forward I'll so remember this have next engaging as steps, to historically hopefully that steps, FDA we're and

Operator

Oppenheimer. with next question Your from comes Mark Breidenbach

Matthew Biegler

potential been This Matt the in manufacturing guess, won't, there amendments you've since way, SER-XXX? donor-derived has protocol BLA donor are changes if And on And wondering the or for to if then, any were I'm filing changes noticed Eric, just how confident COVID for outbreak? is least? headways changes you in I from there Mark. material those or sourcing products that the any any at affect

Eric Shaff

-- think an it's couple probably question. There's a that important I to one. of your dimensions different

as of operations, forward can as we're relates our how spot CMC were the by terms team is continue first clinical fact to last only able The on just think we've we're Cambridge side, also with the protocols, lot and forward week I both but good very that a And COVID-XX moving are it supplies? great in in side. amidst supplies. to drug this tell I the move how And amidst our the a not do we on you clinical noted, fill we of R&D it's accomplishment to And a in the of adversity, that right. indicative is we

it of material, our we availability the good are sourcing about where supplies. to As relates it relates we again, of and as studies feel to biological

in We the with have FDA. been discussions

donor be. we're as the field-leading screening in make protocols instituting are need being adjustments to our we sure to We as right that

approaches But donor that along, not recurrent maybe It this as comment that comes necessary space, we Matt well, as SER-XXX, the to can it that it I think FMT, relates I as point, just it relates and gets relates but only CDI in to have is as but we it to COVID-XX, as know backward-looking, about, the to to we differentiated. on next insufficient, the back right? inherently screening are and is think virus

unique, further? Our you Matt, process. we our want safety and inactivation we because steps most with the have consistent comment to believe do is patient in process

Matthew Henn

to have Matt, the as impacts any not product we Eric owing noted, COVID pandemic. had Yes.

We have always precluded things. the of side donor screening

might We've individuals as in protocol which ill, always rigorous included included not screening and travel precluded regions diarrheal diseases countries such to always fall China. that had who the they're are process. for have countries endemic, collection and ensuring We a where

been donor things. of So we've proactive the on screening side very

can process importantly, are component and purification again, vegetated for that treating acute the be of a problem lead well as our coronaviruses. bacteria really recently to manufacturing the us to we infections believe will And previous as on that what the disease, SER-XXX data and that released potentially from where allows viruses. inactivation as well fractionation and this bacteria did some trial, spores really it's But we publish key of from we -- removed as to I we active various the data our isolate folks exclude point spore-forming manufacturing process, which bacteria, process, shows to such

Matthew Biegler

And you considering? the get endpoint much tagging along mention And to I ECO-RESET, questions of affect guess of data? something with the amending is you're trials' do is, That's the the rid quality one that of Okay. it think primary then protocol, then on potentially you prior endoscopy, the would helpful. touching maybe did that just how

Eric Shaff

Obviously, pandemic. were us to which measure. that. amidst Matt, for it's that detail provided they flexible that We endoscopies has objective lot in hard the of do The comment FDA our a intend are to be indicates an important they think protocol. part Yes. of on guidance, as clinical

hand, it light was other of in the On specifics. terms somewhat

now. study but forging as of considering types -- including, alternatives all planned. by the and we the So, way, originally forward, about are But right those are considerations the that we're was thinking options,

Operator

Gbola Chardan. from Amusa comes question with next Your

Gbola Amusa

breakthrough you you Because the a keep that, the a their Whether enabled for state open, think them Or of designation benefits on On the year mentioned in that benefits little pandemic? COVID-XX benefits a during can X one bit example. maybe company therapy are any comment facilities another expect in to I ahead? or SER-XXX, now?

missed impression may but your much study XXX? secondly, If studies have to how you you results? do have clinically XXX missed maintain you modifications, to interpretable have for do you call, or could think talk it the do actually of And because powering about I then I part about how

Eric Shaff

the thanks Yes. Gbola, for questions.

both, kind come. that it's I is first, and think of of probably the some on the On

that of think So, I fact safety that significant the detail. indicative a through it's patient together that it's -- November subsequent the is is issues breakthrough, We for looking FMT, maybe for drug the it's say as hard to in in new beyond think the related would that suggestive action of the that is FDA we put FDA's think or speak to of right. in COVID a we just the really death, potential mind there the space, related need result the to and think transmission to we solution of never the FMT, a COVID warning meeting here.

we that, think as as speak breakthrough but we with that for maybe FDA, obviously, We agency. significant the don't We're the is the proactively engaged designation. always

from strong is lot And relationship. like I a We have study choice positive a ours. a and has working under that enforcement discretion we'll of data come do scrutiny, clinical think a continue to so, particularly with

continue XXX of studies powering I'd evaluate. we the something on. that it's say that and focused certainly, Gbola, On to And the side, the keenly the XXX we're

of is is certainly, consider objectives. a somewhat XXX XXX key status a and I dimensions in sense different as the is an XXX somewhat think think the there alternatives, the one we fact, in that goals that's Ib that XXX we about and alternative different, are But IIb beyond study, the study, quo. if

Operator

Our next question comes from Newman with John Canaccord.

John Newman

I is bit question has need Second benefit recurrent would more have one. curious little to a just type this in believe show C. a SER-XXX with study asked, the to pivotal a FDA? for you but philosophical study you be to I diff apologize question of already what been if order

I of robustness your the study, I very So, a the you is positive appropriately have for results. which think think C. enrollment will included diff into significantly toxin required test that increase

is, see beneficial have the I test C. question test? they they a the drug The still in have feel positive positive comfortable toxin utilize will those hospital test, physicians that with PCR-based do for your some that a you if using that where PCR setting believe given that also doctors may for it diff is those

Eric Shaff

a right. it's safe it's In that John, -- medical this significant think and for and success I need in need meaningful, result for of clinically of Yes, couple expecting we for space. areas our do are XXX? we're looking is drug minds, One we're unmet both And a significant a statistically what is that things.

On the will that efficacy we've set. that evidence there seen most the space, this a which data medical significant side, And as give is noted, most us you think toxin, unmet reliable where we're is a need. remember we interpretable, clearest, disease acquiring

perspective, we'll I FDA beforehand, appreciation out landscape we I We'll as is. as right intend of a said what the in results. as a shifted the And of a next in read mentioned determine as FMT in to in line safety terms our top option. a with in From key the we've that an and think engage then has study, disease before, the in treatment step suboptimal this dimension safety the view end-of-Phase-III

toxin, that should provide, utilization. continue On reliable be the we is likely our expectation to doctors important. to that again, think, set, practice, as is our in an And toxin. likely data most second not and interpretable it the be PCR is said I impediment to I to their to label clinical John, use restricted the question, determined, think before, think be set. not most clinical critically to Whether it's clear We most data

Operator

next comes Vernon Wainwright. H.C. question from with Bernardino Our

Vernon Bernardino

us, regarding the presence there's far seen there? diff the you far And C. remind patient's independent the And reconstitution own have you weeks microbiome? could the as patients of during their data could? of COVID-XX changes microbiome the what what in microbiome, of if you as effects If enrolled? progression with infection XXX if coronavirus, the a wondered X on microbiome? any as out during of was And have that coronavirus last seen as you Just when recurrent of patient the its

Eric Shaff

study I'll announced data. of the with on that We questions the closing patient But Matt XXX we subjects. at as to relates then randomized to course, that we it so ask numbers, On your were this blinded maybe comment. of actually COVID, to And subject end the March subsequent announcement. XXXnd is

what not So the comment you of missed the I maybe, Matt, can I'm question. sure -- know? what on But entirety we maybe

Matthew Henn

Yes.

two things. So,

the with enrollment in First, existing XXX -- subjects just we trial completed

Eric Shaff

XXX. Sorry,

Matthew Henn

COVID? I hard hear on you question apologize, your the were to question? repeat of but please you could kind -- Sorry, it's

Vernon Bernardino

I'm why patient, it's a Sure. specific rather COVID-XX about unknown, affects say, one the last itself, the COVID microbiome. let's how the -- to still affects but It's not curious, asked reason I and extent trial because

has what February you patients of curious as general, experienced ask perhaps the those from changes an I'm on see to December, early in last say about diagnosis. of on definitely the XXX? that And during have see virus had in even who've of trial this period, the reconstitution microbiome during microbiome as perhaps patients So, beginning what you just the let's trying has an X-week if considering I'm COVID-XX? effect but seen to in January, results their appeared as might the kind results far as clinical the for

Matthew Henn

Sure.

question. the for Okay. Sure. Thanks repeating

I There really definitively early minimal of about think speak very date published microbiome. the been around on it's too virus to to the the has the this. COVID impacts modification to information

to date, the were a single COVID-XX we information, at really big the study, is to bacteria limited point. and that repopulate which be say would have to published the I that on say this I there's And are I not would is we impact looking in that What so anticipate on guts. a can based data anything seen having I think speculation

Vernon Bernardino

question, its respiratory may. Okay. And SER-XXX like potential then about one like acute something in last and distress ideas I Any syndrome? if something

Eric Shaff

want to that? you Matt, take

Matthew Henn

Yes, sure.

decolonize Allo-HSCT SER-XXX host developed the integrity GI disease. as to to translocations therapeutic, in microbiome as to We've So, patients modulate barrier rationally epithelial drug tract improve well targeted key to a reduce is bacteremias, graft-versus-host responses lead cell fermented reduce that which transplant. immune stem receiving designed is pathogens for this

back can infection an modulation track microbiome I'd perspective. there's they Again, in in systemic effects immune impact I and potential immunological cascades interesting think gastrointestinal of the lung. of that active if area know have from may and the microbiome come about an do to, to But how the We opportunity an therapeutics, COVID think work. that's

Eric Shaff

on answer. clarification the The is thanks the Matt, And for Vernon, my thanks enrollment for XXX. questions. first Yes. And

Operator

Your with next Jefferies. Roger question from comes Song

Roger Song

here. questions have I So, three

just the will regulatory for Rebiotix, -- they pathway you data recently. are think one, I'm data may all XXX? line first change CDS? of aware And positive you So, in potential landscape the top reported this curious is CDS how the it's competitive kind

Eric Shaff

good the that for in There overall, for -- good question. thanks middle react wasn't Look, to much It's thing. data Roger, we it's the say good so our a it's a I'd rigorous in I Yes, company. thing general, excited than release hard data, patients, for And year. good the else's most it's in sector. thing. far data that is to, more scientifically specifics a are positive to It's are will of anyone a say for comment me to of substance. we in that, terms

data providing So, this field committed we needs think rigorous clear that we're data. and to

recurrency in There to the spore our in our really will companies which cytotoxin, is set. rigor significant the think the in terms you're number utilization to why this we of of approach, different a think working most requirement of the And approaches. of a think and I reliable space, differentiated we of fraction, that which lead is new seeing study data provide both need of terms a interpretable, we most have

you certainly, which with is everyone's consistent mind safety, our considerations safety. is think the as of most we process, CMC And on patient think, about today,

microbiome we're space, it's So drive year in to data but our important focused think that. be we on an to really going release the

Roger Song

interesting. kind of that question makes positive Yes, second very And is look space. of for microbiome kind news We really forward to all some the entire sense. the

bacteria. the first form the I think the include SER-XXX, disclosed consortium will you For time non-spore

mostly XXX how potentially kind Just do curious, the clinical in you to you think see biological SER-XXX resources, significant for do of spore-form bacteria? so what expect versus -- readout

Eric Shaff

Yes.

think can R&D team, say, it's group I me ask question. to in this team by maybe -- significant But Matt's as our as I on just a well to technological in point. first both further our CMC Let getting comment achievement Matt that

Matthew Henn

Sure.

based And we bacterial trial SER-XXX preclinical critical well on critical saw metabolites the for cell-based responsible our based our had and microbiome impact human data designed assay key key learnings generating on model insights screen that from species an we as was then outcomes. that disease different importantly, SER-XXX leveraged as sets. on mutated disease So, identification of various

the design to the population of forming a as dynamics, us were we strains as post-treatment include spores design. well the engraftment in meaning microbiome the therapeutic good of forming the at those bacteria required and importantly, drug And in information with that strains composition that into not the information that so into at the So integrated about gut spores. were both good

to dosing we the to for needed both strains based manufacturing particular these be advanced our get for on and titers able capabilities for formulations to so spore formulations. manufacturing And non-spore

flexibility the incredible said, of And excited included as both gives for an we're in terms Eric in of I about can be SER-XXX, and also, pretty I that of that as moving think future us but those a company products forward amount kind those advances, bacteria compositions. think

Roger Song

Got it.

Okay. Great.

the So, just helpful dynamic etcetera. engraftment and for

then Okay, pipeline -- it's additional last from candidates, And me, kind of great. is so have question to see good you XXX. Matt,

plan So, kind what supportive. your move if Ib Phase is this just curious, is data of candidate to beyond strategic from

just early, current little bit Just -- thoughts? a it's it's thoughts your too but curious okay if you say

Eric Shaff

Roger. that really been allocate able we've well. on careful comment Yes. It's in an from to period. would I'll a ask say Matt some as general, and very as do based year on This how for program, quite to possible. leading last whether with him as And efficient also the early, comment make And since really I to SER-XXX. but the is I try then important specifically support outstanding partners, been me but this in capital we be of we is that's this we've Nestlé company, this, support would a say let our in -- bit

AZ XXX. with Our but work on and also and with I/O, work MSK our CARB-X

these and and those XXX able really and pleased on in help success comment And But that Matt we we're programs. hope really with for goal to plan deploy to can ask really be us important allows it microbiome in the in move different patients. late-stage So areas, to can X maybe shots we forward our further. resources disease XXX on to to where significant think I to

Matthew Henn

terms cell how has field close at with Memorial stem have partners as Phase our Yes. in a Eric's it this hematic in program, microbiome Kettering, I earlier, understanding of are I highly collaboration as the said outcomes impact transplant mean, who been patients, and led the with an partners XXX, can CARB-X, clinical to Sloan Ib. this point, who of really have our been as through supportive supporting are on have -- well at

data our for reasons: allowed and about really knowledge of to scientific to program it's leverage One, as looking terms that well we published, been learned key expertise build critical as interesting are be from our the we the pipeline, SER-XXX in have of is insights human a have trials and us thought as sets of targeted. And we really microbiome. off of other many that diseases our can key microbiome future that one biomarkers clinical very

the can immuno-compromised impact mortality well disease. very we case of meaningful patients that together in we've have in graft-versus-host And think on a a these as composition XXX, put as

you how immuno-compromised thinking therapeutics antibiotic a you means emerging, to real resistance to resistance more when the think about about opportunity have for XXX, think the in be as we the a broadly advance patients bacteria. I issue antibiotic microbiome with of problems bacteremia, opportunity combat and

Operator

Canaccord. question next Zelin And with comes your from Justin

Justin Zelin

differentiated been questions programs you just touch my if Most asked and have just the competitive space? of some But actually curious how answered. in briefly other on your versus is been can platform

Eric Shaff

Yes, question. I somewhat general following. Justin, would say of it's a Look, the

is our be what late-stage is minds? what and this hearts moves it this for that in an What the And the really view, the needle likely our think I move going we And and data. really quite in incredibly moves that year is a is microbiome. needle space? get mind important question to to in the bit,

And not today. BLA, now, of are approaches years It's a that here. microbiome the and line really the patients here that sometime there's be, visibility from this today. Not patients. in space help XX but it sight think future, to is And to that, as believers we we're we will for respect, that's to why big opportunities multiple help if is in as

we the strongly we've data, clinical successful, for only will And right? have learned I significant to us data, a that be feel a not is which say in What new achieve which following position quite that key best a It's put we bit. over period capabilities, clinical been invested some time, in we've of field. to time. but this We've at

would I not biologically microbiome I which sourced sciences CMC drugs beyond a of point group are particular, the our an our space. in just probably to Matt, CMC our of is capabilities, aspects approach underappreciated growing on the this side house. well of think aspect as And as There's commodity. under

and I XXX As said technological before, are with think, achievement associated XXX, I the considerable.

and So, areas to the to success of put then the in we and forward areas I we've there. very we within IBD, of probability capabilities IO, within our medical think we'll to take leverage place us company and as apply areas that be ID, got positive in position about within to patients, lot lot help and opportunity a increase a strongly think feel need results, good there's tools a in of these forward. There's the position unmet that

way reverse microbiome based the test the in in an human point. us this and is position do from in we're to that our want to human we much as which, Maybe but comment? we know can space I move to we again, learn I sets, can forward, data humble on also move clinical data human experiments, you about The Matt, you animal. ask a is Matt learn so forward. talk capabilities sets put key human There's new have only a think translational microbiome. And to from which best

Matthew Henn

hit insights those us lot then identify target emphasize, would building this enable company and in we back from Yes. can XXXX. a key targets novel inception, sets Eric And since the modality, to which platform, I'll then, reverse focused human to I a on for points, key of the on and that clinical data design evaluate drug was leverage and them. drugs translational mean, launched company and

for of been, based we've isolated characterized assays time, bacteria. diseased in both one, -- been now to strain healthy company, strains strains from define the some rigorously is have I very And key of the a we generation been a of These differentiators long different which investing a heavily large functional using individuals. collection have various and a for They've characteristics. think their library,

both strain bacteria well subjects, insights as functionally, our increases which it specificity as detect to bacteria sensitivity and and that's which studies our of from human really human databases use in reference of analyses with have the because functional ability to the the other critical our and that a detect important and -- metabolites we refine able changes been are We've our and in microbiome key to library our in terms signatures changing.

target assays. we've strategic bacteria, with beginning, these clinical end-to-end biorepository through And the as human putting understand the key which grow ways, collaborations, such to unique really study gone human from capability from culture using ID, starts samples in an place a of the different data various in ability sets, building cell-based them them, them,

said. that assays models to as as that company. different to Each then we developed use pieces unique Eric then that intersect together, our then disease forward different well the confirm use is pathways. these of I manufacturing, targeting improving come And capabilities think, and as animal we're actually whole to various We've a carried as host of only a provide that we

of research ability with capabilities, our bring area to in -- fermented and development design characteristics. and manufacturing active forward have We the key actually the strains

Operator

with proceed at it closing And your this we over questions the back I'll remarks. remarks. turn any have time. please for to no further presenters Presenters closing

Eric Shaff

you, Thank operator. right. All

in on join soon. are to great Sorry, very I SER-XXX hope event continued you able May XX. mute. for our a Have safe. much. Thanks We'll investor your Be talk was operator. We Be you, day. well. on Seres. interest Thanks Thank

Operator

that We participation that please you this you gentlemen, ask for and and does conference. Ladies your today's thank time. disconnect conclude at

Seres Therapeutics (MCRB) 10 May 202020 Q1 Earnings call transcript