MCRB - Earnings call transcript Q3 2024 | Seres Therapeutics, Inc.

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Operator

Thank you for standing by. My name is Bella, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2024 Seres Therapeutics earnings conference call. [Operator Instructions]

I would now like to turn the call over to Dr. Relations. Investor Tanzi, Carlo ahead. go Please

Carlo Tanzi

you, and good morning. Thank

on press results the and with Eastern company's this be website. company's of has News at updated the financial XXXX Time corporate found can and posted quarter The third morning Investors business the website. a.m. & section Our X:XX release the also updates an company available became to presentation

to you including anticipated and regulatory data remind other results development our operating to additional clinical that may planned not generate VOWST related which statements timing interactions and our future of the like making and our statements are Actual and our agencies, the we'll plans timing I'd forward-looking readouts, foregoing the terms about of ability with statements, historical financial payments any and of candidates, to differ cash runway, and the facts. sale, be commercial future results capital, opportunities, focus product materially. and plans studies strategic

On von Seres' Lisa President Strategy Chief today's and and by Eric Officer; Dr. CEO; CFO; remarks, Shaff, prepared Commercial Marella Thorell, Chief Dr. call Terri and Medical Officer. and Young, joined Moltke, I'm with

team of of will available members Q&A be portion the Additional the the during call. also

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

Eric Shaff

Carlo, particularly good period eventful Thank by last you, major a and milestones. morning, time been highlighted has The everyone. X for Seres

SER-XXX and sale SER-XXX, our Ib X and provided cohort positive of support being Phase which our to advancement clinical VOWST, our of the The has candidates. balance second resources first being clinical results lead strengthened the sheet

specific program of in the the to infections, Lisa results leading shortly. of that SER-XXX patients a September reported the in cause bloodstream will placebo-controlled detail patients cohort are data SER-XXX SER-XXX encouraging a undergoing Ib the allo-HSCT. remarks mortality review in X study, from my allo-HSCT. study greater The Phase reduce begin potential I'll with results highly today from risk going demonstrates in our evaluating bacterial we this clinical of

improving how undergoing that outcomes. risk Importantly, we managed in transform SER-XXX patients could believe infection meaningfully allo-HSCT is

breakthrough or QIDP, and and applied end infectious this by have from designation the disease for of qualified both. We therapy year anticipate feedback FDA on the having product designation

validates and SER-XXX our our data of corporate vulnerable further strategy Ib bolsters study biotherapeutics new treatments medically approach promise to live the patient Our bring Phase to groups.

results of multiple solid Importantly, well opportunity. cancer care by facilities. a including piece that long-term with Bacterial we neutropenia, major represent disease, as recipients, transplant infections a recipients autologous liver believe in CAR-T a the allo-HSCT, beyond patients, are in observed as the patients groups with much HSCT we larger acute only organ problem bloodstream patients medical allo-HSCT experienced intensive care chronic individuals and unit patient

represents of the Terri patient potential we've the a by Addressing call. discuss BSIs through feedback received of for supported in will substantial Seres each populations. these commercial research the issue opportunity market commercial on later

more growing reminder, owned protect global infections, value broadly for a public antimicrobial the against not have in We wholly believe SER-XXX. resistant pipeline and to concern individuals potential candidates Seres our commercializing also but pipeline site As including SER-XXX only health of bloodstream pathogens. candidates, against our the worldwide the deliver rights

potential. who To us to populations, seeking enable shares SER-XXX's to most financial patient actively a SER-XXX capabilities additional would and other partner vision are in and effectively we our advance who support and maximize allo-HSCT broad provide

engaged have Partners process. the to facilitate Health We MTS

successful drug enabling financial and the candidates capital meaningful VOWST. the therapeutic advance our supports to first new modality. announced emerge effort VOWST patients sale our to to advancing operations bringing we This now decade required generation focus was a for development. substantial our our the in Seres we product our completion longer-term consideration. over and the next programs the Science an core of by technology strategy sale from of retire live of immediate Nestle September, team to streamline need. future entirely Health the medicine In company, many of corporate into result agreement overcome The in exchange our of to platform on Moving to created as on debt, to VOWST of biotherapeutic challenges

period, developed manufacturing organization biotherapeutics. capabilities including Our numerous and methods live during related this analytical proprietary to

approval considerations live we to FDA closely serve These We also medication, the gained with capabilities biotherapeutics. the class will we and well new new important work regulatory first product the candidates. important insights the therapeutic advance related secure to to of this in into continue company as this unique

infusion, has with received transaction, milestone VOWST resources approximately of retire us XXXX support SER-XXX. of and provide future eligible capital receive in payments upon to The to million continue advancement expect to Through to sales net a immediate are we allowed and capital to Seres meaningful Seres and targets. certain the we'll debt our $XX.X receive payments the we

program on the now move to SER-XXX plan how over I'll to and the we expand pass Lisa forward. to call

Lisa von Moltke

Eric. the post-transplantation product improve prevent Notably, you, Thank designed patients GvHD. and involving prevent bloodstream undergoing often appear in rates infection including decolonize PTCy to to barrier term to a specific infections, pathogens patient a GI pathogens as is biotherapeutic growing to bacterial those antimicrobial with allo-HSCT. SER-XXX population be use integrity in live result cyclophosphamide, increasing of this of epithelial resistance

strain We antibiotic X of and Ib In bloodstream study medical reported drug well infections allo-HSCT. Phase incidence infections, of the in as the pleased bacterial very as to safety, as design with efficacy incidence double-blinded our further results. Cohort Study SER-XXX febrile September, randomized, a such exposure. were utilized engraftment placebo-controlled and consequences cumulative from particularly neutropenia evaluate results we one-to-one of

And very p-value the patients lower believe in XX in meaningful This meaningful. In a X with as a we X.XXXX. XXX. odds resulting result bacterial X.XX reduction risk approximately out of XX%. an placebo is group, HSCT the rate corresponds through relative highly of of of significantly of placebo arm, this day administered experienced to measured bloodstream ratio SER-XXX a out SER-XXX clinically X experienced infection of versus arm, BSI Patients the a than XX

During XX neutropenia or neutropenia or out with occurred aggressively patients practice, at versus febrile neutropenia the compared clinical experiencing HSCT BSI XX often are XX with antibiotics. to who placebo febrile period, XXX-day observation patients, to or XX in lower a experienced incidence of SER-XXX In treated patients febrile a respectively. XX.X, treated broad-spectrum XX%

of As allo-HSCT patients infections leading days are a in death post-transplant. cause first in the XXX

antimycotic we study, a days drugs treated our administered and versus meaningfully mean with exposure for cumulative XX.X for patients. SER-XXX duration being to of antibacterial In placebo these days observed lower mean a systemic patients therapies X.X

time versus the remained SER-XXX antibiotic in group placebo the results When rate we study, highly a lower the group. for on the adjusted meaningful exposure and

well to was generally given identified were into highly that was grafted SER-XXX the were SER-XXX and study SER-XXX any species adverse especially GI designed. serious tract from Additionally, were and attributed as study in confirmed that the tolerated. events cultures any The no SER-XXX No This in reassuring the subjects. patients immunocompromised.

different summary, profile, with supports of data development. favorable important In all potential which clinical safety across we these measures, show SER-XXX believe along benefits with a X associated future

patient as CAR-T with We the opportunities are to in recipients. working additional patients neutropenia such for while to development advance and next auto-HSCT, allo-HSCT, of SER-XXX exploring populations cancer stage

as and the the need, agency benefits Therapy with QIDP the with receipt review. Based significant responses designation the and through unmet year. with have the from as we on and potential these FDA, The observed development by noted, hearing requested Eric designation and results mechanisms important could frequent we agency and anticipate designations Breakthrough provide of review expedite priority of the to end such engagement the

the of allo-HSCT first process. with intend for based registration agency to engage prior quarter degree with study the next VOWST be Additionally, the study next in We potentially in high experience clinical our believe a the plans on development studies. the and need could unmet we regarding our approval year of single SER-XXX

We also incidents BSI primary basis believe endpoint. the to be as compared placebo for potential that could the

to tractable and and study next FDA. will steps Additionally, our we following the as the be size with be design interactions study informed could

With will pass that, Terry. call the I now to

Teresa Young

everyone. morning, Good

Lisa, and CAR-T in patients medical unit well the patient by As transplant cancer disease, recipients, or care major neutropenia, problem infections, long-term patients stem including solid intensive are cell recipients. recipients, care bacteria facilities. BSIs, you've chronic acute and Eric liver with transplant and with as heard other autologous allogeneic organ experienced bloodstream individuals multiple as groups, from

Our rated a their patients first and and patients Seres. could infections, for significant these allo-HSCT HCP about address high highly opportunity be treating X In BSIs to scale, recent concern of on this reflecting concern. is is X-point a market research, a level

like with common, increasing, prophylaxis do SER-XXX is antibiotics the While of high shared remain infection do. adoption are reportedly of cause quite PTCy. root to rates to designed due earlier, as Therefore, BSI not Lisa and address antibiotics is

to due quite readmission. The problematic ICU course patients BSI costly for is complex, allo-HSCT hospital and with and

it today's is into HCPs large that new product transformative cost using patient much across In of costs and This should fact, surprise $XXX,XXX be oncology clearly in a HCPs XXXX. globe, cut quickly centers treated allo-HSCT half in would protocols. per reach in option a treatment rapid that SER-XXX, were Therefore, would standard potentially to efficient be manner. and the educate higher us tell be a in at subset estimated infection transformative Furthermore, since can no and rates which possible from incorporated incremental patients are the about data XX,XXX like it a dollars.

SER-XXX to begins with within as well as nearby infections vulnerable to other it outside while oncology to for populations summary, opportunity allo-HSCT, the of prevent In or in malignancies candidate. medically extends biotherapeutic and our adjacencies areas hematologic SER-XXX

for potential, our significant blockbuster deliver Considering multiple patient opportunity. we which populations all target highly see could the strategy

to Marella. now With pass the that, I'll call

Marella Thorell

a VOWST $XXX net the $XX Thanks, as with investment statement Terri, consideration Nestle a in was the by was the in our received the Included to impact less transaction of September million prepaid and Seres to $XX Nestlé. well million Seres milestone upfront and on settlement as related million to payment will VOWST of equity approximately $XXX and good Beginning financial from financials. quarterly at an of related payables close stock transaction XX, everyone. which related million to Seres. $XX review terms the I morning, common million, the presentation consideration to

from installment due receive using the with million the less material XXXX payments are payments of proceeds employment-related million XXXX, to provided we Oaktree fully million in terms debt transition transaction. of January agreement. in compliance $XX $X.X our the also in We is services and retired $XX approximately in to Seres July

following Science. team members and Additionally, decreased a team is Nestlé rate. company's well the Health a transitioning lower with count to our due head of by team to more members to from principally progress XXX company approximately efficiently Seres burn transaction, strategy XXX cash The the quality manufacturing to positioned

implement cash identify We actions. continue to and preservation further

September financials. in results as sheet business consolidated quarterly for VOWST reflected within our to the statement the VOWST condensed operating of classified historical comparative has financial XX, of turning consolidated balance XX-Q. the period and discontinued company the business In the for December condensed in the XXXX the Now in operations statements, XXXX the all XX, operations discontinued operations are presented periods for

extinguishment a September and completion the interest quarter with debt, net loss of Seres third was associated $X is loss VOWST from of at compared to reported of loss which the quarter million. retired the in primarily XXXX. in continuing $XX $XX.X million operating result a operations offset the a expenses higher income the Oaktree million of reduction by the in of lower same the in period of $XX.X as $XX million, The the million of sale for for

a period expenses million was consultants. In the development were operating lower and overall of of and the driven quarter announced last restructuring lower reduction XXXX. and for for fourth the The as in in resulting quarter third $XX.X efforts personnel plan result with year-over-year contractors costs, million decrease by primarily cost continuing $XX.X the costs research same such in as compared the operations, year

IT, XXXX. the costs for same operating the were was personnel third with and the professional primarily $XX.X decrease aforementioned compared expenses such again, costs, lower restructuring General million driven result in with and along in million as lower continuing a headcount-related The the administrative as quarter for $XX.X by fees. of lower operations plan period

million, of gain loss of million million $XXX.X completion the for net was sale in The of discontinued a the XXXX income third the difference $XXX.X primarily of is period in with XXXX. VOWST $X.X quarter of net the operations, approximately from of recognized upon tax, of the same net was as the on Net for business, which September. the compared tax, result

to now position. our cash Moving

equivalents. quarter be operations As had Based fourth of plans, current to XXXX, to we and existing received projected installment in fund XX, the cash transaction-related cash, XXXX. of million in ongoing September obligations $XX.X XXXX, cash and we into payments on expect operating

creation value in maximize to groups. we live opportunities evaluate patient continue We programs our as biotherapeutic seek to to develop various

financial externally our partnerships both to products populations supported as and populations. partnership We create development patients and costs, by efforts, could of believe commercial to A Eric, capabilities that through and our pursue while highlighted value. realize the internal programs target significant evaluate including potential development benefit in clinical sharing to could value is of us accommodate enabling and deliver across both multiple patient commercial other there

the pass back now call I'll Eric. to

Eric Shaff

Thank you, Marella.

observed observed bloodstream observed, rate are consistency we about We infections, especially measures the the our regard the reduction antibiotic to and febrile made we by systemic support are the have including to program, of the impact have we as actions With our the the of strategy. future of neutropenia. progress in encouraged as clinical of rate SER-XXX the that related the in lower significant sale on have with excited we VOWST pipeline taken exposure of well

SER-XXX continued a of patient at new high results for the in serious approach. need with The of treatment group risk allo-HSCT infection a and a support substantial development exceptionally

We multiple live also medically bloodstream major biotherapeutics in believe infections, need groups. data to of patient that to our validates groups risk our a broader at bacterial vulnerable bring corporate SER-XXX unmet strategy

bacterial large mentioned. approaches with including needs Seres analysis have patients risk these which recipients, CAR-T bacterial substantial the cancer patient neutropenia, populations markets, infections infection-related These to clinical for new opportunity groups, many various believe severe address and our others in consequences. commercial with the allo amongst outcomes on we of high a previously auto-HSCT, substantial of and represent of Based to for patient negative address exists infections serious

value believe we concern. bacterial health antimicrobial proliferation that potential reducing against the SER-XXX additional by candidates a of global and have Furthermore, our emerging deliver the protect pathogens, resistant only but not pipeline individuals to also infections serious

breakthrough our QIDP the We progress with continuing applications. FDA to and our interactions updated look our you on to forward keep including and

spontaneous developing we in and disease, bacterial disease, bloodstream SER-XXX, antimicrobial Beyond patients liver infections also and are to activities. advancing live IND-enabling prevent metabolic biotherapeutic are composition with resistant chronic proprietary another SER-XXX designed peritonitis bacterial we including

we SER-XXX the broadening expanding you well SER-XXX in the as longer patient forward allo-HSCT goals our pipeline. updating we've outlined noted, and We as As advance to this are term, on strategic populations as our look across focused in the for morning. we priorities

questions. that, up With call operator, please open the to

Operator

of of Joseph first TD comes from Your question the Instructions] [Operator line Thome Cowen.

Joseph Thome

would this mentioned, patient partner? something you sort on the additional one well? cancer a as of neutropenia. first partner separate each that a would the be those something Maybe from some basket with these you of I independently auto-HSCT trial? this is that And and populations like Or a Or would that Phase guess, I you is studies? could you from do help do

between different the just or difference of is between SER-XXX XXX, strains what's of kind in And on and a composition there sort the difference then maybe X second, molecules? those

Eric Shaff

questions. thanks Joe, the for and Yes,

we're the the as interesting right? XXX mechanism of one that patients example. adjacencies, auto-HSCT of that is idea similar well for the one with think as I to really as looking allo-HSCT is It's aspects the impact

to maybe of from But would the study, I'll design ahead the Lisa to of relates always comment I as that comment. clinical getting FDA. a refrain ask we it

We breakthrough We to as await let then responses question. of have Lisa for your QIDP, hit said. applied can those me the second we ask applications. comment we've and But

Lisa von Moltke

over allo trial clinical that's have structure get formally basket the we've we will might be in arm to results established in definitely analysis seen an the vulnerable within anticipate or current and is details. specific this population remain the which a that nicely just start was given study most more not in would Phase triggered interim looking and would to the synergies probably patient, that that But a established in be on of safety population, the I We needing that have terms Yes. of to whether absolutely, in a program. our

Eric Shaff

Yes. that. Maybe just can I add to

of we've interacted with data heard release, the thinking we've from interest cohort adjacencies As allo-HSCT. about following second the KOLs

not that, XXX XXX, relates those what about have as Matt it. comment to or Joe, XXX, minds. we're ask and compositional the can on So physicians' we are XXX disclosed specific maybe on I'll XXX what perhaps to to but your differences, hoping and we know second XXX, streams to of with in on question comment it achieve ask Matt that's the between XXX I design

Matthew Henn

Sure.

So that epi found in XXX are a and patients cell in XXX bacterial impact transplant of the XXX, designed pathogens are that, stem different hematic know of you that consortia bacteria set have was context target an of on as barrier. particular well as commonly to

well and overlapping chronic distinct liver of context disease, in as of causing disease an we're but talking exist problems commonly the pathogens XXX In set liver that patients. are about

So that to does that address XXX capacity have pathogens. around optimized It is also set barriers. epithelial of

differences. So the main of the those kind of X are

And environmental then are gastrointestinal disease quite the patient has the in unique. liver XXX addition, chronic population conditions in track. They

take And designed so actually consideration. into the consortium is that to

So formulation address strain those challenges. and that to selection asset on decisions there's

Operator

Romero Your of the of JPMorgan. next comes from Tessa question line

Caroline Kimberly Pocher

is Romero JPMorgan. on Pocher This Caroline for with Tessa

take few Is from partnership? bit the materialize? terms what you what if to in time by finalize a are a for you on profile a the SER-XXX? the for there the event just when for ideal a were partnership Just would an color little could you curious us. does And And provide would steps a potential seek be potential partnership internal potential you of partner frame not could more SER-XXX? targeting an We

Eric Shaff

Caroline, thanks for question. the

patients. to One the about in bringing program could to beyond think look allow that But of partnership, several accelerate us capital we for So that, to itself. SER-XXX it capabilities we is relates things. support as of course,

is a example, study. So global as to next be we the an know study likely that

That's part of that can a patients we to see we which these could move than as think could one we work study. way the else more next expertise, example So in someone with sites of in move quickly relationships global ourselves.

for that, objectives of interest of really an what and of SER-XXX do could someone values Beyond potential of who patients. look alignment for we sees the really

think attributes, that think about some we basket guides of the we those of as about partnership are So that parameters that process. this

these relates We've that judgments it processes hard and to we the the to relates the certain As guide. pas, it partnership to point do it's but as and to in interactions line we'd study always relates quickly, with we B, obviously a several to think point A processes partner, as from line, they're want there's a and been next not through that straight move like in move the don't to timing. FDA always to it with of design time predictable

So we need the study, the that selecting new sites. activating with about forward we're CRO, move for including doing the process material next do identifying manufacturing of clinical thinking the to including and things to study, the

that forward. held, someone not is forward working of else but we program and bring All being look do this with to

Last might steps we was that partnership. if question get we take don't a

our and to the XXX forward we're and answer excited prospect on and move on the being of our think about within a we're I able short with our is partnership. focused forward focus a getting moving other partner is attention is, That's areas where portfolio. with

Operator

from Your Tenthoff of Ted line Sandler. next Piper question comes the of

Edward Tenthoff

for maybe the years lot Is in infections. how now I the the do focus development? the of arm the XXX down transition the products Seres a this. the I on here sense X targeted those of to these XXX one discovery and front-end get with think I'm really sort of get programs makes where of X see trying you envision really companies? you of goal down X for to multiple would road. you trying is and It data yourselves? yourself being partner these take for to and get see maybe supporting Seres road to larger there the focus likelihood research Is sense beyond? sense, Or a these Just you a ever sort of and on then

Eric Shaff

and thanks it's interesting Yes, Ted, an question, one. the for

innovation, field, where in taking the to calculated date in think, I on tends right? And least collaboration, the we the about kind that, of and as company's and it's the front definition, to the a development, have development. value, in think most the of pioneering history, we I drug the created think by the risk new that -- end the at in be discovery been

on FDA a patients. right? and totally the including a we've of forged release So treatment become that in path totally multiple for And learnings, think to kind pretty goal us of area, with on with shots an like a framework new new things forward we engine modality specs for the creating there some is really move important

excited the important those definitely companies infections the of space, that they significant the the excited opinion, have absolutely but cetera. and other development, legacy manufacturing an the many sustainable And ultimately say personal groups. you the one, in think Genzyme, about opportunities will Amgens, to my aspiration have medically We're created and prevent is included about Biogens, think commercialization. in and I if et vertically discovery, XXX. we're first Genentechs vulnerable value, about We to patient were biotech the integrated SER-XXX do that. I of of really the history

I small, ending could on idea could that call commercial of are certain we're the the thinking lend and and different be patient focused really think science, to prescribers knows state knows that and these really infections up indications a have the different there for where have themselves which that that -- are really footprint physicians about, actually we targeted populations. that points these in working the

that's goal. So our

R&D focused side. as term, And company value we're of best for obviously, Nestlé remaking a more in we the driving short the can. on function really streamlined But of and the way a fashion, the kind shareholder focused on in that that transaction it's in the now

Edward Tenthoff

all Great. color. a I our that of certainly, sense to makes ability for medicine the appreciate Yes. partners. in the lot manufacture on the manufacturing And expertise future

Operator

management I back remarks. over will now call the closing the to turn for

Eric Shaff

look forward Thanks to great connect all operator, you, to very you this soon. much. week. Have and soon. . a morning. connecting you thanks for Thank We'll of joining We with us

Operator

that joining. you today's for call. gentlemen, and concludes all Thank Ladies

now may disconnect. You

Seres Therapeutics (MCRB) 13 Nov 242024 Q3 Earnings call transcript