SYBX - Earnings call transcript Q2 2019

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Operator

Good afternoon. Welcome to Synlogic's Second Quarter 2019 Conference Call and Webcast. [Operator Instruction] Please be advised that this call is being recorded. I would now like to turn the call over to Dr. Elizabeth Wolffe, Head of Investor Relations and Corporate Communications. proceed. Please

Elizabeth Wolffe

XXXX Good This for press plan afternoon outlines second John. today's us release to and several our call. and conference we quarter discuss afternoon, today. you, that joining thanks on which other Thank topics results we financial issued a

The available Investors on section at our website release is www.synlogictx.com. the of

Scott Chief Shegog, Chief Todd Joining this are call Officer; me Officer. Aoife Officer; Executive Plevy, and on Scientific Brennan, President and Chief Financial

of and upcoming our will our including Aoife the Synthetic discuss we outline July, their platform, that will the a During released summarizing recent data progress. provide summarize our and recent Biotic before brief implications financial quarter, milestones. call Todd and Scott events for the results for topline of our in finally the Aoife will development

our Following the remarks up open prepared questions. call for we'll

to I'd statements Reform the As made like the today forward-looking Act Private under we remind Securities Litigation may XXXX. include everyone begin, of comments

SEC. statements of forward-looking forward-looking change made earlier as on assumptions, Forward-Looking results including result time. and cautions forward-looking of Synlogic's reliance Statements the uncertainties as those under in Factors statements hereof numerous described to various heading any could the factors, Actual you contained the are under those undue press today and release not over place materially which subject any a the from risks These are Synlogic's recent Synlogic in later differ Form factors, with in date filings from most or to in Risk heading statements. XX-K, or

to over Now the I'd like call turn to Aoife.

Aoife Brennan

second and XXXX call you everyone. upcoming to financial for results, Thanks, discuss joining us And progress afternoon, in thank Liz. milestones. recent our quarter our Good

class bacteria environment. be respond perform living our mission can great of medicines of nonpathogenic synthetic functions. designed using progress another making biology and to to therapeutic to their This We're class to engineer living new develop to medicines, in sense

provide potentially place at right that to living the the is a design a Our time therapeutic and medicine can disease. goal right address in solution to

that potential suit technology diseases unmet on the our focusing medical that have and address We're uniquely needs. to

Our that engineer we have initial functionality to the in programs a have we the disease indications good the of and need address biology, bacteria. thus to to are understanding into which designed

diseases to phenylketonuria that PKU, PKU. metabolite have in consume disorder is This includes metabolic X or strain with which a actor, designed functions the Phe, we or as been genetic such for phenylalanine a engineered has bad SYNBXXXX, which the toxic

hyperammonemia, treat disease cycle ongoing a with we SYNBXXXX patients consume results that strain in as be will also in conditions designed dead We've shortly. called such and to liver study Ib/IIa clinical to have engineered SYNBXXXX that urea Phase an ammonia. is cirrhosis And disorders.

for disease, and potential such broader IBD, our Biotic disease Synthetic inflammatory or see also areas medicine We bowel as in cancer.

order Synthetic to or a towards have develop sites these moving collaboration platform, learn applications. strengths and is tumor, We first its SYNBXXXX, potential AbbVie IBD. first for orally intestine either and Biotic in the In distinct about and we delivered intertumor are to medicines And programs program large action, via small of injection checking future our with oncology clinic. our

iteratively, We our knowledge for are enables engineering, basis as also on E. single that Nissle to us future programs. as coli focused to currently chassis a learn this to the and apply

complex a our Biotic we functions to patients. significant SYNBXXXX diseases. Synthetic making the platform data potential. for our in key half had into several its platform time first activity from busy very And We a of of We year demonstrated released and progress administration our in had the future understanding in the our for engineered first multiple in We've and microbe, humans are a program. first first generated of a differentiator

covering goals our to the we advance of to other develop all as data the patients set or briefly we the a programs. recap path We age believe program. I for will plan type. in track PKU treatment have for disease forward achieve on as our to well a remain later regardless call clear the We

top quarter SYNBXXXX from with trial line our ammonia. this and of expect in Phase We clinical data cirrhosis patients Ib/IIa elevated in

data said supporting we've development with and of As before, outcomes will SYNBXXXX. the ammonia task decide lowering we other on

our SYNBXXXX. this application an We first also program goal IND expect to IO for our achieve filing year of

combination inhibitor is and lymphoma. patients intention as as in advanced a with to Our in checkpoint with monotherapy, solid well evaluate tumors SYNBXXXX as the

with centric we PD-LX-blocking To announced access the use Roche quarter inhibitor this end, the this to earlier agreement in to a for checkpoint for supply secured we that study.

make continue with AbbVie to In addition, our collaboration. we progress

calls. forward look feature to of these in programs each providing I more on details

platform On power that added synthetic in as recently to and synthetic a capability living harnessed deploying range And on been the conviction industrial cells biology solutions biology announced a private can be Ginkgo We Ginkgo including to our here human for additional very provide we with collaboration with and root engineering this in problems, based to achieving the Boston, microbes share biology has of their biology successfully front, Bioworks. focus applications. is significant a of that synthetic a disease. share we vision. company

engineer multiple and Ginkgo and has novel optimization to and across manufacture tools an engineered understands synthetic Biotic has can the a microbes. Synlogic design screening of experience of therapeutics. in-vitro sequences, process biology vast and applications team use to that a and biology of access built Synthetic engineering industrialized significant that synthetic database these medicine genomic has develop disease biology

of with which and our to together clinical a Working them small strains collaboration pilot us results. As many work and this made more in to using been We've sense. one prototype a their had Ginkgo worked very we trials of you for enable lot bring of on process compelling with into know, asked will to candidates optimize looking Ginkgo ways superior efficiently. with we a project optimize

to Synlogic stock. so. to Ginkgo the We're of million $XX in their or and the of Ginkgo at agreement next the number investment we that set to committed excited our have $X X significantly. share, work the brought our services price for as years million to $XX commitment with on skill equity Ginkgo premium very a demonstrated complement expand Of projects the their spending the in, a a with closing capabilities partnership over

in project call this as I've asked Later collaboration our Scott a them. provide color to on first more setup Ginkgo our little we with

guidance. to Now briefly let the financials over through run to turn call updated our and me the Todd

Todd Shegog

June Great. of pleased Thanks, financial results to now. review Aoife. After you And XXXX. we of close quarter today, results everybody. our with the afternoon, the second market good And XX, I'm ended highlights those the released for

quarter for AbbVie compared million XXXX. for with million same develop second Synthetic the of XXXX periods medicine compared were collaboration in with bowel inflammatory Revenue million for the both to $X.X were associated a treatment Synlogic's $XX.X in operating $XX.X to the Revenues same for ended disease. XXXX. expenses Total XX, XXXX, Biotic three is million, $X.X in period for period of the June the months

cost decreased and our our Development programs, development cost. million to partially XXXX Phase The other to support cost in same trial increased I/IIa and were ended due a $XX.X XXXX. SYNBXXXX was of quarter million the $X.X compared second decrease developed program for Research development offset primarily expenses the as in for period nonclinical clinical clinical by research decrease in in and

XXXX period expenses General $X.X for second quarter million same million XXXX. $X.X the compared of in the in to were and administrative

release for quarter or share corresponding reported million net for you XXXX, press period For the $X.XX a $XX.X consolidated per net six-month a share today's the second $XX.X of of loss to a per or the results. million consolidated company of summary XXXX. $X.XX refer the of year-to-date in I'll compared loss to

balance Turning cash balance synthetic their equivalents, advance In $XXX.X in strength XXXX turn ended back Synlogic summary, short let call through report in the $XX from services, to Ginkgo cash, the investment in sheet. emerging second to I'm quarter cash and that biology Thank and long-term the over sheet XXXX. of million with the to additional services me to of prepaid pleased resulting million with the And the our investments. agreement the programs we ongoing clinical middle Aoife. our you. have and

Aoife Brennan

Thanks, Todd.

As early into and strong of next that lead to we have programs to stage advance our Todd our development pipeline. several development us a position cash will outlined, move stage programs enable the

to specifically recently from data clinical cohort I/IIa Phase presented patient lead our Turning of PKU. study the our of expansion with programs, SYNBXXXX in

confirms data they in important confidence formulation safety was in in In the with will of activity be This as of program. patients the by to SYNBXXXX information in that SYNBXXXX the in activity further provided summary, this this to and very its healthy us tolerability solid volunteers. of to gave bridge data able pleased in and tolerability the equivalent formulation that evaluating and this about development for oral we confidence of volunteers. behavior our We're us patients and liquid population gives SYNBXXXX healthy that plans

Phe active blood Phe a being into use lowering We human guts. to how consuming engineered to can estimate Together, consumed allow much We us data SYNBXXXX Phe SYNBXXXX GI also pathways then tract. established by that the range is are in both human within modeling these predict the of across datas.

provide trial with used data mid-July. of was that lowering, at lowering in study it will to powered conclusions valuable the efficacy While the The top Phe information a were material. not a to be did presented demonstrate design study Phe main solid line

Inborn symposium Errors of at at the of an X. However, Metabolism be or metabolism. Jerry and of will is Medical we held Genetics SSIEM Vockley, the will of principal of trial, UPMC Chief in Society provide for The inborn being by September the on one Children's dataset Hospital in the errors Study of annual which presentation of Dr. the X Pittsburgh to oral full Rotterdam expert given the investigators

on oral the next formulation from are optimized step. to is moving I've our liquid program? material frozen steps prior As next what the solid mentioned So calls, the a early for critical

GMP in manufacturing our critical was capability us internal establishing quickly. Here own move to allowing

the establish process cell optimization trial clinical bridging our completed study is underway. maintains currently that to of made that viability a help process, have materials support our lyophilization in and We volunteers fermentation

to study this healthy the first do volunteer We subject expect month.

fermentation and formulation the our the solid if I/IIa dosing enables of to will formulation In SYNBXXXX evaluate our activity study. better the study liquid tolerated that Phase a new we in with higher process evaluated

first believe dose. move study half the we'll establish information an a in can this will in of initiate with hand tolerated And into XXXX. we maximum We in patients that we efficacy

learned earlier confidence medicine. and what we also design that are phase project programmed established note platform perspective gained a stage in from important at multiple the can human which We deal they as are one engineered we Synthetic Biotic bacteria bacteria a in do functions that programs. doing body. provide this from is great we should that study I We our advance that to

in experience healthy of We and and systems also the better how patients. model a they volunteers gained clinical of value into translate understanding predictive the

that Finally, this our the be the GI medicines learned we activity of tract. small to for in can other intestine, programs opening up that advance the possibility active in Synthetic Biotic us require part

early gears about our now in had how we're this and at to hard been back development, Ginkgo moving earlier him his our Switching I've the programs work I first maximize is to the to platform collaboration and at Scott that with Scott? the say asked month a value of words going. quickly up collaboration company. mentioned setting few

Scott Plevy

Thanks, Aoife.

As exciting imagine, synthetic expands clearly access to But months role we accomplish. really biology company. of now great broad scope what place, delighted been lead in have new it's the capabilities. me you we the can with at Ginkgo this for level which is resources to few of agreement step what I In into team first can a was the accepting our whole an with

area to resources a avid excited to to very and applications It's teams together. is and very keen on busy therapeutic both working delighted team which them. have that relatively work Synlogic are new a the been is Ginkgo are the team Ginkgo be The provides, time for

setup to and together, decisions how a be work made, to working of advance. will been programs communicated progress structure have We how

Aoife prioritizing identified validated just Another both Based which the an PKU and our and the diseases embark the on have projects interest. pipeline. toxic that areas to together of metabolite reviewed, exercise platform there is data other has many priority where impact metabolic upon on determine most been are that we could

immune address stimulating therapeutic significant where In I to immune response due which to of the encompass needs cancer the an as inflammatory response is diseases important and addition, over-activity and medical potential platform effective an as see such immunologist huge diseases immune-mediated tumor an against unmet in our for strategy. indications

more platform. and of the directed let back our in us on Importantly, strain the to to speed at but up. hand to expand our it size in now wrap aspects development focus engineering to Aoife allows forward of collaboration the translational providing I detail look internal and human Ginkgo future, capabilities biology the you me

Aoife Brennan

data SYNBXXXX but confirm subsequently for to will Phase first on An top Scott. medical detailed and disclosure. were data data scientific Ia/IIb from a line Thanks, meeting. presentation remain study our and will independent we announce track present measurement assumption as the We accurate as more line a suitable monitor analyze as or unblinded our top ammonia

are the patients blood cirrhosis you, to study ammonia hyperammonemia ammonia with lowering seen to forward We look in effective drugs coming hospitalized. safety the with plans ammonia XX% not Just crisis a program and and in had a is have and for lowering endpoints to this which detect being XX% sharing the other indication. weeks. data the our blood elevated in to but remind The who have yet or is powered tolerability

program. track as We earlier, I inhibitor. on already I supply checkpoint with also clinical the specific this information around material agreement a sharing plans We've IO program, future of calls. and remain have our forward mentioned a clinical on made to Roche more to our trial Again, secure trial for for plans an with look

data heard and look as pipeline several preclinical on to forward providing working as progresses. from Scott, you've detail finally, also advancing we're more year programs the And new and

needs up, using of for medicines biology of to of principles making change life platform of to Synlogic a With our in sum the variety patients. medical address life we're and the at progress in designing the tools synthetic rationally to for living quarter's that unmet activities potential indications. engineer our this patients biotic the synthetic have dramatically significant To we're potential of understanding

We the forward have several to rest year. look development milestones to during of the

position will milestones cash to Importantly, we emerging advance programs. our lead achieve strong these us a that clinical allow have in and

conferences including I'd like month the will in investors investor this to Wedbush several presentation, thank conference have for Scott. you to at be the us SSIEM which the the opportunity we will fall, this afternoon. participating Besides joining later over meet

We call open the will up questions. now John? for

Operator

from the [Operator Instruction] SVB Leerink. Joseph from coming question Schwartz First line of

Unidentified Analyst

Hi, in bit a for could talk for question, for about I'm your bridging our was SYNBXXXX. Julie dialing first little if study wondering, you Joe. I

and studying. to many more test you plan I be mathematical are we doses of XEXX CFU, how bridging Just the study, which have of CFU those a that you're you some your detail, using couple subjects what And XEXX identified if the doses you could in your And expect model, to will study? was doses thinking follow-ups.

Aoife Brennan

study, of So healthy in volunteers. terms the in bridging it's going to be

with escalate, we case. efficacious we start was as at we dose tolerated in whether will and to escalate. Phe dose get dose liquid, We a being like of within can that potentially range that And identified well-tolerated we then a that's we will well the that see dose we'll lowering. Obviously learn the the terms would as

answer X So in terms been it's designed of really to main the design, questions.

The first to solid the dose tolerated the formulation. is oral maximum one of identify

a over ramp, a is the start individual in as tolerated time whether up patient, dose the low to increase to is profile. meaning maximum dose improve or dose objective identify them second tolerability we going The if

they in had, And patients I and continued Phase on if dose. it dissipated. nausea with trial that vomiting the first the often dosing, and had was generally saw nausea we usually And vomiting the if they

initiation similar that kind of actually the leads drugs believe the that dose around period. a tolerability dosing lots around help ramp of of to the us the improve start other that So to may of dosing

the going that's So objective. be to second

impact administer think be stomach into impact bacteria acid giving to Phase this us stomach activity objective, same acidic study of of understanding And environment. help the going of on into how we're whether bacteria the feature And needs it buffering. forward trials, product be the coated, the stomach from giving like really formulated could to II we then would the at we whether acid, because bacteria, really through We're to live enteric protected third the an buffering time. need

being kind to drug studies the successful objective, really it's sure as if guidance subsequent those in make start will, of So setting studies think give chance to I very development to success we the think important subsequent we one and trials. a in to about those able products being but provide a for you patients up of pragmatic best

kind as the design those that's disclosing study so soon The around And we X have objectives. X of we'll answering And as absolutely be is data. questions. data, those

Unidentified Analyst

was Okay, considerations that very about more could wondering profile. product talked a much then little to mathematical at you doses bit you great. target your call I you conference achieve model. your identify the that. you Thank And the last about that the just can briefly for And last if were -- just think made your talk

Aoife Brennan

so pillars, will. if on really two the you based mathematical Yes, main model is kind of

pillar dietary levels. before was The that on the Phe working was the was and phenylalanine really started Phe content PKU, dietary we around literature, in first data understanding that blood on available of impact impact,

So a healthy much looking at volunteers PKU Phe subsequent reduction how dietary was would subjects, and in to Phe patients result with healthy and decrease.

model took did, by much we our What that we Phe consumed we being was calculated bacteria. and how

the tract. dietary consuming going having bacteria within made that Phe same reducing as assumption be intake a we So was the GI your Phe to

assumption I you type of think a of physiologically of if balance. Phe-in, a reasonable kind Phe-out think that's pretty

on made should blood assumption consuming the we have the that bacteria Phe, as the intake. Phe dietary Phe so same And we reducing impact

dose profile. how to in we achieve what to -- Phe to plugged we impact target was And are And prediction the model then based what And but at product into were nice biomarkers range the our that needed much calculated our be. very we showed XEXX blood XEXX Phe us of the that tract. within would really on that GI on XXXX, consuming how we our a what the bacteria create did biomarkers was the that of

instructive. was it told us what needed It to very think we do. I So

achieve I second X risks think to that's is, Phe very can short we correct dose in are -- risk then address a of that think And our the key can going key we order. modeling plan forward the and with the it predict fashion well-tolerated. and And those actually lowering. do that those a does program we have in is both questions

Operator

from Next the Nochomovitz from Yigal question Citi. coming is of line

Samantha Semenkow

the suggest evidence on have to X Hi, I this And like specifically if like looking previously as range that? XXXX you outside manufacturing you're thinking is you've the contaminant. for. tolerability the the new will that any I generated solid formulation questions. prior of that cell process just that there have say for And the any could Yigal. build preclinically wonder if Samantha particle can Is you've on on other evidence shared you that support the not

Aoife Brennan

unfortunate no preclinical Samantha, the thing, tolerability. that is there's GI of Yes, model

to of we've several identified and is tolerability have any really high dosed preclinical that doses terms So derisking informative very and vomiting. or the clinic. in not models in and But not nausea

potentially the very we're that XEXX I us dose think dosing program the and well and has of with currently where patients XXXX the gives a been in issue addressed best confidence what tolerated disease. is evidence our in at clinic, lot have from that the we liver even

does XXXX look Lyle XXXX. look of we we liquid when formulation quality at XXXXs across liquid formulation It than both XXXX. the the the at the critical like and more and that of new much program, XXXX original it So looks attributes think comparability the the

that And tell. best But ongoing. evidence study have the we'll that that's the question think the know we will answer in shortly. to definitively obviously I is time that we're And pretty So ballpark.

Samantha Semenkow

validate drugs as FDA-approved you there modeling way then Kuvan? to your the specifically reliability against new way work, like like model, on that is any the And can, of any benchmark

Aoife Brennan

intake. patients our that's to think Phe actually we applicable who've this data actually work back So that patient to ongoing, the is their kind diets that's And changed is going applicable for product. be system and most We is the validating the we've of is us in the we've think reduce benchmark their what model. that done plugged think most into -- to we

made then diet, can have that what So and data sets terms Phe change pre a of doing diet good we've data. make to model been working dietary major robust change done the who as is on identify we've a have number as where with that someone their information of possible. switch we've they to actually try been They levels. in and post That's what KOLs

that not programs well We terms other through a developments of PKU. our but in multiple can just of help think therapies it's model really interesting as thinking and program,

the to so been to with excited validating And they'd their and academic it playing own and with dataset. kind excited we've be of provide of to tool start that kind very this community

Samantha Semenkow

week or the are that, details. on PKU to then a just day And week just variability helpful patients Thanks. monitored outside like levels, in what of is Those or to physician? day say Phe clinical building even normal patients' being the trial among by

trial this in And relatedly, patients in might Phe your effectively setting? planned you expect outpatient an impact do that detect the to ability lowering considering diet X to Phase their fluctuate

Aoife Brennan

Yes, yes.

X good questions. that's So

there's there, components several different in think Samantha. I

of The is the variability, XX%. around first Phe coefficient one somewhere assessment, about variability this in it's terms for of which

and if patient a repeat even X you'll Phe XX%. or and you it times, take sample about a see one So of X do

the trials of In terms deviation blood in prior Phe prior XXX is about studies, of the standard micromolar. longitudinal

It's all the providing and dealing design design kind that at a be we'll we'll with. working the what later now. powering greater detail of that's consideration, But on kind currently of take so of at out. I that think and of into time really assumptions we're But absolutely the And II the that doing point. trial the study of work the that's we're Phase

that so I maintain trial. sample II variability Phase are variability in by need, the a lots stable to assumptions patients and what possible providing diet around diet limit to of what's had size controlling think the extent a the we supervision

down we'll those all to with soon have that's absolutely regulators, ongoing. work walking various details the be And as that's So we them. as nailed you

Operator

the from is coming Tenthoff question Jaffray. Next of line Ted Piper from

Ted Tenthoff

the liked was last on just lot really And how that points too. interesting variability a Scott's relationship the the discussion commentary for interesting Ginkgo to you and comment Really particularly me of update. changes. Thank on in

for of then that so in that sort clinically as a you I Can does and how from weave data sense of indications? does of so have of sort you look future Ginkgo. forward help any that How kind prioritize capabilities particular you you get much. kind the Thanks far? change And

Aoife Brennan

doing focus just being Having to we start to as of imagine, that that of work, It's to make really and and Ted, we yin focus. spread a too capabilities best really on a matter exploring be forward the it's that areas lot of you with a But run been of we as areas and move access narrow is would balance kind sure a we can wonderful, how leverage. get of disruptive of we where area that can balance. across biology. also different it right And and it's can We've Yes. don't it have us thin doesn't, there. away yang we multiple always well that as let Ginkgo's the outside but

hasn't and kind I to So within focus, those focus really of and biology think I diseases it two opportunities access that we're needs areas initially. And while We buckets. unmet think that our with really on X medical of fall into going are there immunomodulation. lots think we to changed diseases the which those diseases think there are ample capabilities the amazing, metabolic on is

lot no patient with not of adequately, There's Phase are designs, there's developments. where reasonable bucket can late-stage can we II/III first we've identify more perfect. really a and where that of we work programs low new been ourselves take that populations There's fruit no through endpoints. developing registrational hanging drug development in The required terms in prioritizing forward mid-

to the those of of considering through internal kind commercialization usual take various, that be an can are selecting that of relatively we'll straightforward attributes, type But kind product we the all form ourselves.

I platform for been gone think that have other success us. companies before a key that's factor

and from that. learning we're their so And path pursuing

the where biology an second think diseases we exquisite fit. bucket I are really see

our and category. context competitive fit we you And capabilities areas. a be a bowel see occasionally advanced with undoubtedly across in -- collaborator to an data. trials and commercial who are programs for and into good science maybe I that's And disease are data think falls large those of may great not landscape So and around our those late-stage that be really Phase inflammatory too ideal mid- it but internal kind very and to just our pipeline, and disease, II that come biology which And synergy I those to the of applicability think brings great new development ignore. the

think that continue of we're because programs partnership right distracting I discerning and don't program. in And in to you'll partnered be that if can mix think the internal partner see move I planning the quite to But forward. our we be as you choose right

anything seeking, kind So to that's Scott, of have you else know, we're that, kind if add the balance don't that I if to but that's of strategy. the

Scott Plevy

through have potential and time over a now went to the we lot prioritize strains of going how move add this some pairs just taking hurry. internal in and long terms talented many our problems more of faster of is work in think Aoife hands to us and Ginkgo this in a troubleshooting what generating to would They is to that team terms what automation enabling I a take do. to of many,

about So we should hopefully more able clinical goals. be to really getting programs talk towards quicker

Ted Tenthoff

Okay. sense. color. lot that extra Makes of Thanks for a

Operator

coming H.C. from Raghuram of question Wainwright. line Next Selvaraju the from

Edward Marks

Ram. This on is for Edward

liked I post in Aoife, off, week this First your LifeSciVC blog.

Tecentriq. as as simultaneously wondering wondering either other combination the with any you're And arrangement can, And or in in the checkpoint combination with monotherapy? if from if with first in working Roche. sequentially? I as inhibitors XXXX I'm much was just on planning with you're testing you describe a question, Tecentriq XXXX while assessing restricted So you're

was evaluating immune other possibilities moving then in And combination forward, with you're about with considering currently. different whether regimens Plevy talking the cancer, Dr. there's

Aoife Brennan

Yes.

blog. of was the study So long flight thanks last It the terms and a home the on your from week. Europe comments product of in – for

you glad enjoyed I'm So it.

In terms study. of data oncology

going it's So to be two parts. in

injections first thereafter. going once an be going week regimen do to for you're three a XXXX. monotherapy by The dosing part with monthly injection weeks The to is followed

agonist, tumor, within We've that for some the life environment very our really small have seven preclinically about STING within of short demonstrated micro contrast half a in bacteria persists the molecule to days. which tumor the

how that's of most the the preclinically. up we weekly of was monthly maintenance. kind with kind regimen that unefficacious And So was came followed induction that by regimen

know, So the the with that both our based hopefully design the Tecentriq then monotherapy on on is we'll safety and you obviously Tecentriq dosing of weekly, have on that Tecentriq we monotherapy some for some is in data once XXXX label study based biomarkers, regimen data treatments based study. there combining The be of simultaneously. on the PD have we the but, we'll not the part Tecentriq. will be would initiate regimen the And and evaluated concurrent dosing

if to types move make a we XXXX for by tumor And we think follow program. supply was unencumbered start for us And Roche that very other obviously did do of other as restrictions number because of we partner. and can what can of attached flexible really of strings had Roche the consideration Tecentriq. sure options. be the potential XXXX reason in we that that in as with few for explore an specific data, We collaboration kind obligation terms of that a the data the did supply suggests, different or one amenable with with with other the about agreements, needed, of is tend quickly and a with The very the to important opportunities kind we kind reason want to they terms and exclusivity to

the kind beauty that the So of was Roche of agreement.

opportunities bacterian detail we'll detail more our cancer. is and XXXX how about have we strategy, be additional thinking kind about as both other soon of on oncology Scott on we're currently as for working that, overall And providing

We'll is in other affiliated appreciation cancer, move I true and kind about started when that terms an people. not Synlogic, But this years therapeutics for started talk been X to a of funny to got in there's has started about groups say therapeutic a of papers bacteria the and needle bacteria. of from really of finally, journey ago, potential that with acceptance we kind think there high-impact as we looks we of kind recently number from

that. see been we've So gratified very to

Edward Marks

mentioned comments following immune-mediated around just arrangement of then the way I in some you little in the of though then partnered strategic going And sorts using about could I more exploring intent it some and IBD. that, it into the on arrangement remarks that partnered program. detail would diseases. kind to you'd looking be is that prepared are program, diseases, a for the yourself? you of regard? be biotic any details on a more much what this go you. platform Dr. synthetic Even if hoping Thank and his mentioned move up with of Ginkgo that if was you the of there Or see. mentioned you was in a it likely that I inflammatory particularly you wondering for be Plevy just to was

Aoife Brennan

and the off start real for could unmet -- therapeutics bowel mic still then has I disease, developed so Yes, pass there lot inflammatory medical of present pro. needs. Obviously but been over tremendous to a there's

it really have options. could address be functions of diminishing that needle to within [indiscernible] and X of with biologics, starts multiple uniquely things that other like positioned available returns small companies other other We those to kind been barrier who've they're really address inflammation PKU platform be all demonstrated factors molecules component the transformative after combining the can improvements. our think that other simultaneously. and issues and is treatment smaller therapeutic so our just smaller recently on patients this programs that the maybe incremental for of protein we've to we platform program move that the idea unable of other you exhausted within or barrier think could orthogonal of a biology disease really function case going and some But become the where And

we're So could kind fit. with very impact very, the about not today, vision. IBD that's And a good for there of think meaningful patients really that be the but we're potential to and a make really it excited

Scott Plevy

Yes.

just these IBD one response might So just for enough child is poster target be any isn't of One children the to rates maybe why long-term therapy. poster remission and Aoife that's therapeutics future immune-mediated are low I diseases. across complex -- paraphrase inflammatory disease where said, what so of is think inflammatory combination good and the

although proof for to of in bacteria. matching and designed may the And or for mind was of combination principle, my in the and development this of of hitting excitement real ability drug focus monotherapeutic validation of classic and over in a is in a platform we to What fashion combinations on be targets my the in platform excitement complex therapy. to these coming diseases specifically either better this Synlogic same platform mixing the bacteria one multiple within

the a of systemic other looking spondyloarthropathies, diseases biased conditions it is And of at you're neuroinflammation, all if but maybe in opinion, starts gut. inflammatory joints, the inflammation this

have pretty we questions. think down years road some answer novel platform really the to I So a interesting

Aoife Brennan

Spoken as a true gastroenterologists.

Scott Plevy

I but truth biased, think there is there. Slightly some

Edward Marks

you, from was a appreciate so it. all I case any Thank great it guys. In me. description, That's

Operator

coming Mark from line from Breidenbach of question Oppenheimer. Next the

Edward Marks

Aoife, say? the go/no-go PKU really Or of given bridging basis healthy in unfair potential is looking patients, as just decision a phenylalanine on should similar the we and conceived that study to thing levels for you've in seen a turnover development? be at wondering volunteers an continued

Aoife Brennan

No.

I you not think if you're or make should prepared my the time you're bias. really go/no-go to a question drug That's then you study. that every trials, if whether doing not decision development do clinical

puts in a the So level it get kind of need of line terms is sand to. think we the I in modeling dose the beauty what to of

find a that and moves setup. I that We we Phase a if think we based think trial a back then have the tolerability to we'll into the clinic we get into can't of But have issue ballpark real that look think need get at we forward that into the addressed have. based whether on we analytic the IIc on lowering type we we data modeling cold program our that have

that turns prepared we're out think critically see to to the we to look need at think data the I it that to very we if efficacy. can't So do level dose get actually and we that

Mark Breidenbach

if talking into fact study bridging that That's program with well, dry about All forward all not at formulation that to you wondering SYNBXXXX switch the be to want I'm powder would a as And right. we for reading correct? fair. moving should we're also the yet. Presumably, we're if

Aoife Brennan

Correct. Yes, yes.

Similarly in They have haven't haven't XXXX, as the with to slowed been program. data, biomarkers. with any something at moved the steps looked expected. We So obviously bridging funky we the we that ahead investment wouldn't with study. next

it similar oral you And there with for we can that And a formulation. learned right think assumption, are XXXX. XXXX by lot applied only to program. XXXX we of oral think your is expect that on the the to And any absolutely can be solid these type I programs transferability [indiscernible] in lot you're a path believe coming fixing we've learned is forward behind. across for we've the what that for XXXX of really of programs

Operator

line Instruction] question the Jefferies. Howerton coming [Operator Chris from Next from

Chris Howerton

them been more collaboration. that it, but you had further asked that maybe provide would of the most and obviously kind Ginkgo and very little Aoife prototype this you was on, obviously, of think to a of that had I can like a you thing I So have strain earlier encouraging said if one given was information results spurred

features they had time? that optimization Was done they it it better cycle previously, about Was mind? what actually that did of terms was potency? your In in What there optimize?

Aoife Brennan

Yes.

optimized program at a MSUD study. tested we But it of we at pathway Ginkgo. pilot some we very Optimized, maybe said [indiscernible] way. had okay, we enzymes the possible here we the of had strain, data type with to it the We Phe. to enzyme the had presented So our of let's tested a with is it had kind -- over pass best had the X this effort, XX limited extent couple was of built and a a and each of orthologs

thousands other basically craft versions there perform of subset that perform process do that was of data of up pathways, potently. into have have cell-free real we [indiscernible] at on work. And different of based basically than kind question in individual was the optimization what enzyme our that to [indiscernible] took They each small each Ginkgo. kind with better system that X enzyme the proprietary did. to sequencing a a most that's they appeared any type multiple of didn't came screening orthologs They And their enzyme screened genomic They look actually does here. better, they of our

kind Then they setup. kind did kind the can type only of combinations. you remember this how of have this you I can't couple And of do automated is when another, even many, really of of work industrialized hundred

rapidly. bioinformatics process of wrapped experiments You're the in so all running different talking they about around parallel that thousands have and very that very, they can that

higher what enzymes work capabilities with very that into we'll turns to didn't of that It only something of other through better. we And substantially and that of of a their you component accessing, well. was screening kind potency. they to tapping there. have more more established different think assess likelihood have did of say they've they that of you And as that the But expertise other is their excited we're achieving now improved additional multiple start orthologs be individual multiple kind capabilities. capabilities will out nudge screen the powerful. was We That kind that I

So pretty we're to excited get going there.

Chris Howerton

Got it.

of opportunity related Okay. Ginkgo so that there organism using Bioworks a be appropriate construct commentary dose. to to Would amount And getting at then lowering to profile to Phe XXXX platform? prior the related perhaps the an tolerable the optimize

Aoife Brennan

Yes.

day, nagging over smiling every is that. I've So just been on to to about here. touch Scott That's pass might him something I so

Scott Plevy

better what's around with throughput Yes. better we in their basis having But Absolutely. screening is up this many out and how Aoife's are massive these maybe day-to-day And a activity. that pathways may to be on a we before. activity. point help on literally us productive potential of limiting And house are snoop most that high other example just future. with an where might enzymes interesting in and the in There wheel do is could bottlenecks -- they conversations amounts enzymes -- coming manner

Chris Howerton

it. Got

just one is maybe I then simple you a exactly clarification And right. formulation Aoife. delivery, of said, what very All Okay. and because in hear terms didn't

specifically to For do that that get you intestine, to you? is delivery small how what achieved? think the And

Aoife Brennan

Yes.

pH no of one that current the we the bridging in that's impact So to We're versus study. at the buffering buffering, questions side-by-side. comparing want of looking address acid

in that the healthy similar patients out to lot kind that with acid a small that us of consumed the food with enteric model of buffered answer hypothesis. that so the II/III product will know of healthy using that's we is look allows delivery. that's going that's it's optimized my will in either a go We're in this activity. So that really some intestine? what healthy hypothesis PKU best we been some volunteers think kind coated be with the volunteer give volunteers. in evaluate for fact or solution, of that us a something kind the important that's buffering Phase questions And when we We capsule So type so still, activity that really of these to

And kind of that's more like, soon planning we're as So absolutely kind you looks to we'll as of address walk that. how what we on through that clarity have exactly it.

Chris Howerton

Right.

understand terms small of the I that buffering kind that. it, so in viability say. right, guess the intestine? don't the guess understand pH drug I I heard if it to could is the why what the is stomach of the would of low And and specific reduce small I substance in of you I help the But intestine activity quite

Aoife Brennan

right small perfectly compared get to active kind away the down doing such the – the to small you're intestine, delivery released need large and to the colonic them be think with is acid may the bacteria issue fine. get that's you of they intestine the be I whereas to needs intestine Yes, then halfway if stomach

where So I you think want on depending get. it's them to

I to depend will want really rapidly you think available active. on be them how and

to We of viability. has internally that pH look we've on systems stimulation where an impact buffering on systems see absolutely at in some and simulation and pH cells, impact access those built have acid human that the we can stomach gut and we

the that expecting that human. we're in will so the same And be

Chris Howerton

its to component sorry effective small consumption? it to Like phenylalanine be would I'm -- any And reason but ask more there to question, is or GI in another a there's bio-geography bio-geographical that other the intestine component some Okay. the tract? believe

Aoife Brennan

Yes, very absolutely. little Phe the colon. There is in

based the really And data are that we saw on validated was of phenylalanine. we by So through bacteria optimize where we we activity And plasma want intestine. with live the of kind happens XX-hour that's to magic TCA. think biomarker a small co-located what that duration saw

based on validated completely physiology. that So thoughts our

Chris Howerton

All right. Awesome.

Operator

from Julian coming line of question Harrison Next BTIG. from the

Julian Harrison

all progress. on congrats the recent And

good get IND accepting involving as feel how filing There been closer sense [indiscernible] on have the therapies approach? is the XXXX, you you for some of a to intratumoral like partial bacteria. So for FDA have an past you in do general the

if curious a standpoint? XXXX intrinsic I'm there's it safety from anything about So that makes risk mitigated

Aoife Brennan

terms in on, Julian Yes, spot our getting rodeo of this you're so first INDs isn't open.

So that we've precautions, we have the going making kind of sure time, taken a all of the with FDA ahead usual plan in. robust meeting risk mitigation

that you can all a the in So kind of outcome. of we positive hopeful XXX% works But never and have obviously, are for be sure.

has but In the terms see concerns tools bacteria, And some of safety hold. with of when alive both in on the that the have the why obviously then potential bacteria, us programs biggest other that we with help to of risk the some gives feel to a really been historically. clinical also biology increase that's particularly efficacy cancer. But other infections ended synthetic used up we the

preclinical in there that disabled, that. confident pretty validated are replicate actually vivo. multiple and are bacteria they models Our with We don't in

that And will updated, time actively that comfort, we'll to FDA providing infection think reviewers as will we the around an particularly tell. of that soon So risk. as give the But a level be we you. have

Operator

at back questions further I our the this now like to no to time. showing turn conference am speakers. I would

Aoife Brennan

you today progress our joining John. us available any We'd thank the questions. months. are follow-up be to there in We'll updating developing on call, we across Good you look coming for like and to if today's pipeline later forward on evening. you, Thank

Operator

Ladies have today's your and gentlemen, participation. wonderful And Thank you conference. day. for a concludes this

all disconnect. may You

Synlogic (SYBX) 10 Aug 192019 Q2 Earnings call transcript