MCRB - Earnings call transcript Q2 2019 | Seres Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen. And welcome to Second Quarter 2019 Seres Therapeutics Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference may be recorded.

introduce for to conference like would your today's host Mr. I Vice President, Tanzi, Investor Carlo Relations. ahead. go please Sir,

Carlo Tanzi

Thank morning. and you, good

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

study plans, I'd remind sufficiency cash equivalents you and our statements potential timing, the operations. to results the like potential that of forward-looking fund promise development therapeutics and cash to to impact of enrollment studies, clinical clinical designs, competitive advantages, matters, of the regulatory relating data our trial our our we'll be our or and and of making microbiome any

Actual results may differ materially.

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

available also portion CEO; by I'm our On and Seres' Chief President Matt our Dr Officer Officer; Kevin Eric of Horgan, Scientific this is Shaff, earnings call, joined Chief and Henn, Q&A by phone Medical today's for and the Dr. joining call.

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

Eric Shaff

presented number we and Carlo and changes important of at pipeline. a more conference good became the of outlined CEO the Thanks, morning since we everyone. quarterly On in-depth last call, company, I review our a

will our now strategy have today's clearly as shorter we We defined. keep call

promise prioritized that execution is therapeutics we diseases. programs. focused on our modality the a treatment to and is Our are develop This microbiome-based serious we mission believe holds tremendous of new for

in SER-XXX our colitis. These Phase study are IIb ulcerative

collaboration study candidate microbiome ongoing Phase our ulcerative Our in SER-XXX in as our colitis. including And finally, next-generation infection, study immuno-oncology C. fermented partners therapeutic our preclinical work our well AstraZeneca. Ib in SER-XXX as melanoma with at recurrent SER-XXX diff metastatic our III Phase for

our clinical microbiome the capabilities Seres efforts an capabilities related manufacturing discovery, novel advancement and We R&D to development. that advantages with this are of these to modality. Supporting treatment related competitive Seres deep believe important therapeutic drug provide

XXXX expect SER-XXX Seres, important year XXXX. results our in two with beginning including milestones and exciting programs for an data-rich late-stage to study We be with early

data expect quarter metastatic the We SER-XXX also XXXX melanoma our second our SER-XXX study half the in from study XXXX. third in from of of and

provide programs. I our turn to a will of to now call detailed the clinical over review Kevin, more

Kevin Horgan

Thank you, Eric.

development FDA FICO multidrug-resistant death our patient discussing, organisms. related from to Microbiota to Before clinical reactions adverse safety issued the transmission June. resulted in that the programs, and Transplantation would I or to a alert related FMT including is address like serious FMT of This

unapproved this different are the practice. to our alert Importantly, drug candidates than Seres used FDA medical fundamentally in not as does apply FMT

of comprised of conducted candidates with bacteria controlled consortia IND procedures. in drug highly reporting purified rigorous clinical studies spore-based under monitoring and Our commensal safety evaluated are being an

stringent and are candidates GMP manufactured and quality standards using Therapeutic product to quality controlled Seres consistency. conditions ensure under

fully they and in contact clinical candidates. bacterial between our We sites that the ensure and understand preparations fecal other have been with drug differences to FMT Seres

derived colitis. candidate Now, comprised a administered tract. human in in to bacterial gastrointestinal I'll is from study SER-XXX, patients turning our orally healthy IIb active with moderate living drug with to donor-derived the programs, begin Phase which ulcerative mild is development commensal SER-XXX spores an

a has drug serious for novel option microbiome result outcomes first-in-class SER-XXX and a trigger treatment objective to believe and in is significant a the non-immunosuppressive in of inflammation. may this the that candidate We develop microbiome disease. this improvements to potential Our modulates patient with amplifier therapeutic as provide

eight with vancomycin weeks Ib difference compared the between SER-XXX for in significant study clinical placebo patients statistically by Phase remission SER-XXX rate the proof-of-concept completed to a group. treated prior daily A demonstrated followed

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

those clinical Microbiome provided additional published biomarkers mechanistic consistent clinical associated sets with are microbiome identified obtained from as and insights project. data transcriptomic activity. that metabolite that observed data human treatment and results, support we the and therapeutic microbiome initial with clinical remission Following help recently the explain

FDA product Importantly was we profile by as administered one SER-XXX registration. this in subsequently Phase placebo. of expect study SER-XXX ongoing seen the compared support for could initiated feedback, pivotal to adverse SER-XXX compelling in IIb no study. with that on highly ECO-RESET the data events safety Based favorable Supported imbalance to patients serve studies two written we these

have CHMP who to regulatory as also Medicines' European ECO-RESET Human studies pleased indicated could that European Agency the we registrational one Committee marketing recently, two on More the of also obtained feedback application. to from Products were support Medicinal serve

The colitis randomized ulcerative moderate SER-XXX enroll placebo-controlled three induction will prior that with have ECO-RESET arm who active is trial a patients XXX therapy. approximately mild to study failed

weeks pretreatment XX regimen In same the rate. the of of Phase by two of pretreatment daily regimen trial arm, In vancomycin arms, arm receive the in clinical patients first arm, SER-XXX receive of the the by followed Ib that also eight of first weeks same showed three the lower used highest daily followed second followed the the dose. vancomycin by a weeks in remission patients as

was weeks Ib to In of SER-XXX plateau trial, seen two engraftment of SER-XXX Phase administration. the after prior

the on for period. based learnings So that arm, our and third the from only pretreatment regimen both study. In treatment a received this evaluates patients during arm placebo mechanistic

recently provides enrollment WCG over clinical services trial sites execute study company Canada. to to engaged accelerate our continue specialty assistance that we of enrollment on that and this This help ensure enrollment. the XX with well-known projections, with ThreeWire. a To sites at clinical at U.S. track stay is across We enrollment we

data in third the We XXXX. of expect to top-line continue quarter

randomized ECOSPOR versus study. diff standard-of-care placebo-controlled either a the receive is health to receive I'll subjects all then now the weeks diff acute placebo. placebo the III patients reduce recurrence. in C. SER-XXX to ECOSPOR rate where the in resulting the and eight SER-XXX study is dosing. antibiotics and pathogen The microbiome, rate infection turn treated C. SER-XXX to up diff to or designed restore the endpoint diversity with SER-XXX compares III infection of are III subjects of Phase to primary C. qualifying address after who recurrence resistance

As previously, the ECOSPOR III size to to readouts, we the accelerate modified while we have XXX reduce have disclosed to power. to study clinical top-line timing maintaining the statistical patients

infection steady of report expect make to use the early face continue top-line we C. the to SER-XXX and of XXXX. continued data We progress to study in with FMT diff treat in widespread

on Phase therapeutic the similar with immunotherapy. Moving to our study Cancer Anderson placebo-controlled patients will of Cancer SER-XXX to Center, XX based Immunotherapy we therapy. program. melanoma currently the candidate to anti enroll Ib checkpoint and microbiome metastatic for inhibitor with PD-X the with are collaboration randomized signature FDA-approved patients study. an Parker oral Institute responders MD donor-derived This observed microbiome receiving in the all In an SER-XXX bacterial SER-XXX a gastrointestinal is that nivolumab, enrolling

either Patients are randomized study various and a safety biopsies X:X placebo. evaluate SER-XXX to biomarkers and tumor also or at clinical ratio evaluate will of response. and The immunologic

half SER-XXX in XXXX. obtain the Phase second of to expect study preliminary Ib results We

on endoscopic ulcerative functional from improvement biomarkers study. our microbiome Phase SER-XXX, colitis. therapeutic advance to fermented insights associated microbiome mediated continue a our with of Ib for and SER-XXX SER-XXX designed rationally incorporates also treatment the The candidate of microbial remission next-generation design and pathways of development preclinical We clinical

We clinical for XXXX. in expect file and to development initiate application SER-XXX IND early an

pass now to I'll back the Eric. call

Eric Shaff

a provide Thanks, loss to morning. compared we in Kevin. second that XXXX, of this financials note data in our issued of I period the of the as net brief net I'll release a reported Seres is million of and will million overview included the $XX.X loss $XX.X for for a additional XXXX. same press quarter

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

deployment the quarters levels lower that expect up changes the this our resources quarter, we be corporate year. in expected of a next used year. The implemented quarter incurred clinical will to was for earlier remain of the and proxy of lower this focusing quarters, the to subsequent cost-cutting recent the result pipeline readouts leading to level the and corporate We expense sensitive of cash relative second

Seres net receipt $XX.X due This balance in offering annual well our ended a installment equity as public approximately with terms cash cash and $X.X first of the payments in June, under of in includes million the the of as obtained second $XXX.X in quarter million million AstraZeneca. proceeds completed the cash with equivalents. three collaboration

from plan, business of future current operating Based expenditure XXXX. flows activities on operating excluding the payments fund incoming or capital quarter to into and requirements, cash milestone resources potential cash net our first development are expected expenses

the to our coming sufficient Importantly, reach capital with have to we year. anticipated inflection the now expect events raise, in resources multiple significant value recent

fund. pleased were Flagship existing to through support had investors Pioneering in participated new new a offering and public the our we and investment continued of have Both

are delighted to as happy Berenson, Seres' continued am engagement. we welcome this have to I to at Stephen very Board. Managing Flagship We Director Flagship's And morning, announced

I a As of the on call, now we the in at period are beginning mentioned clinical execution. focused

SER-XXX, and including is multiple look SER-XXX studies as hard quickly milestones late-stage SER-XXX with our our company to extremely meaningful programs we exciting being two enroll XXXX SER-XXX SER-XXX. and team Our expected, to working possible as forward an and year

the data next area The emerging microbiome microbiome. be a truly year medicine. sought that field that has could We clinical could for believe period definitive long this of validate landmark

employees to the patients investors voice in As for continued clinical our I conclude, our support. to I'd and appreciation involved like studies, our our your

open Operator, line let's now the questions. for

Operator

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

Your line is open. Please go ahead.

Chris Shibutani

morning Good much. very guys. Thanks

as with FMT. safety FDA the they quarter that think During to related I the had you problems the the saw last described alert

at has SER-XXX possibility with observation observing ability enroll? As are trial, to in And out a that the you all FMT you're terms is what enrolling safety there? helped of patients that your into III you of ECOSPOR there

your can a who with for of been appropriate kind assay? study? gets what this the to the proposed Roughly you've what's you've that like specific And they based may toxin. being trial the is end the up center your maybe us XX upon qualified have every yields through, think you through with selecting be candidates genuinely looking they for a then Thanks. diagnostic specifically SER-XXX, patients patients given tools, processes your Obviously, for at sense that toxin related part that potential gone to more of that on yield give for are

Eric Shaff

ask Kevin I the first that as terms will ask event your but question. space. of FMT still for the morning, let speak to for to we was XXX into do well accruals, seeing will question. that it our the is to piece of in me it the time of yield the as fairly on recent in the Kevin I caution you space going impact comment Good I'm And both the -- thanks question. significant parts both part, significant the on for first will be Chris. the say for think

Kevin Horgan

Yeah, Chris.

and -- we terms this to about see we too on -- that think any obviously So something to discernible effect to at in say But fair reflected that, a been closely, early of we haven't looking I been that think and it's it's as we we've at conclusive this is point. it's that. make this to at enrollment able determination point

then eligible. best question, negative the not kind be with have the patients regard data of therefore single toxin undergo -- is that the to second to mean, those I in are out we're approximately one-third patients we and And the what study of that that screening of turn point

to are key get from So who approach that's that our I novel the our think confidence here that approach in that's to really is benefit our intervention. enhanced likely the it's the most patients message right --

Chris Shibutani

the is news the be to is any back? discussions, practicing sequel anticipating follow-up anything there couple is you FDA changes, doing any that of the that perhaps that notification that guideline what that Are came a across to there'd to in And community? months

Kevin Horgan

Yeah.

FDA possibility seen. discussions remains to overall know has think the approach amplified how it a of landscape I be this situation. the distinct kind and complicated about I that's this that of to -- the that within

Eric Shaff

some dialogue just with Yeah, are clinical what are a you're we if with physician, to – in an add relates speak about And to that other we we that, our obviously, FDA, approach out the the them Chris, contact are makes as it of we I to is it event. for think sites. if but doing why opposed would patient approaches you're in we don't the we're And like believe taking sense there. a to as

Chris Shibutani

at for an that And could a safety additional might that of that the accumulating I would of as believe in do safety of single thing? you or type itself be then like ECOSPOR exposures as data, on the that be eyes? you it from have freight this number there's be FDA's patient's slide the III submission in on far sufficient the confirmation data terms of in the study it, be trial finally, noticed that of do that and sufficient least you. enable you you'll study and Thank current should approval feel end

Eric Shaff

we exposure, will that and potentially commitment required of be there engage Chris say define went fulfill safety happy through orphan would forward. with I a path in others. have call. Yeah, results earnings we just Phase If detail breakthrough find We open-label report that to we to different this one I designated we to is the this clinical don't last ourselves FDA anything background new our think program. to a a say some avenues department in with think again IV number residual are is positive a if that, very a I'd for right

new to concluding and with but the on will that have end, look positive expect course, So forward we what to study there. be of result go report will from don't anything a we we

Chris Shibutani

sharing Great. the for comments and Thanks you. good progress. the Thank luck continued for

Eric Shaff

Chris. Thanks,

Operator

question Thank line you. of our comes And the Chris Jeffries. from with Howerton next

ahead. Please Your go line is open.

Unidentified Analyst

statistical kind is here. but My morning, a EMA? trial the previous question for would for it's Chris. question first is clinical the terms would Hey, a a significance can pivotal? of really what as there by or the in guys. give it of asked just that really as amount FDA This the to for both Saeed Thanks that to – be you it of as good related to pivotal question designated related [ph] a acting potential pivotal what significance certain confidence in taking take that serve and XXX Is

Eric Shaff

Saeed, Thanks for that comment. me ask on Kevin let that to – question. the comment on

Kevin Horgan

will echo that But be the FDA we endpoints I from totality the is clinical context the transcriptomic of very then feeling we of strength in confident and the we it is totality was endpoints that data, be standard that to will why the what Yeah, primary it data. and review And obviously, of present, are the data the because that it kind and we that's objective issue with got. response blinded a meeting we will of I'll feel so small which the think data centralized of the data with study, the data, the albeit got our the and data but Ib convincing. the aligned the various elegantly endpoints endoscopic the the really Scott that is data and the reads microbiome metabolite in

the compelling that study. it support being So pivotal a think we present really be will positive a will to set and study data

Unidentified Analyst

Great. Thank you.

helpful? be that? dosing that there to next something curious just milestone the with Just – or question more that you're my So entitled color what or an some filing, related very SER-XXX million was IND else the exactly would and I first $XX payment to trigger that as is perhaps? would the Is to. of

Eric Shaff

this won't that the and of I that in Eric. in past type to in and initiating the except to do We've for Saeed, future, is the million. specificity think, the we're of contract say terms we $XX development that with we that language clinical program, receive Yes expect the with not work that doing provided

a they've of with for in provided -- been that move have program for milestones to a and about financial it. SER-XXX and partners to and us our excited important provided terrific clinical including support perspective, the really has Nestlé from the company happy our progress their the financing forward we're past Our partners us

Unidentified Analyst

last the that million was $XX million I question raise? in cash the inclusive raise not that of million that you you of $XX of here. kind had, a Perfect. my inclusive or believe Again $XXX question clarification said

Eric Shaff

of million the was raise. It inclusive $XX

Unidentified Analyst

Okay.

operating is is So lower over put then, OpEx I there you $XX you a could look there can $XX sense run way the of like what to -- mean going you that it's probably around be said, way that a could couple going rate next any to sense -- a quarters? I like put the million around could a that you forward? mean of sort at million expenses

Eric Shaff

I rate likely Saeed, fairly QX our prepared seeing at the in Well, rate run my if remarks be you and more over I than our what to that -- numbers, XXXX of was what and our prior said clinical QX indicative QX our think was numbers to run significant indicative decrease historical our up a said readouts suggest. in and we look rate you're what run

we a first remember, were our those quarter February programs. implemented portfolio run the rate in made and because of in seeing quarter, highest priority this the in of streamlining effect and on of costs changes the those be may during year our you of And numbers. corporate in As reflected second changes our our announced focusing -- four you're really or quarter second a

you're seeing -- forward the our you've more is past. what items, the way, expect seen you indicative going a burn one So, versus in I of should think part if what one-time see of you the

Unidentified Analyst

for you and progress. good Thank guys luck taking -- the you. on Got questions the questions

Eric Shaff

you. Thank

Operator

no Thank company questions. I over further you. like the showing And further for And to to I'm back the would conference remarks. any turn

Eric Shaff

in Canaccord note you Seres our I Thanks keeping continued operator progress. Conference forward we of be thank you Therapeutics. that appraised tomorrow. will and will we look to And attending the your for interest

Have So, a we forward have many of morning and a to look great great week. seeing you there.

Operator

great thank conclude the disconnect. and in and for today's have you does all Everyone Ladies may This day. a participating program gentlemen, you conference.

Seres Therapeutics (MCRB) 6 Aug 192019 Q2 Earnings call transcript