SYBX - Earnings call transcript Q3 2018

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Operator

Good afternoon, and welcome to Synlogic's Third Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end of this call. Please be advised that this call is being recorded. I would now like to turn the call over to Dr. Investor Corporate of Head Wolffe, Relations Communications. and Elizabeth proceed. Please

Elizabeth Wolffe

third and joining this Section at several us Thank outlines we you, discuss today's of Investor for The afternoon Good our which we release Earlier www.synlogictx.com. Andrew. the on topics results plan the thanks conference website release a is press of XXXX on that our quarter financial issued to and afternoon, today. call. available

and team, members me Officer; Brennan, including this Officer Officer; briefly financial results management update Corporate an on are Operating Synlogic's Miller, Paul our Joining for Officer Todd Medical current Chief Financial Aoife several the summarize Chief and Chief our of quarter. plans, Executive and will on Scientific Chief Head programs Chief Andrew President Aoife Tom provide Gengos, of Officer. will senior call and and Development; Shegog, and

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

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

those trials of including synthetic facts the in forward-looking recent immune without a of release differ include in data. in historical forward-looking under reliance heading statements using wide Synlogic clinical of factors biology, to Synlogic the clinical any from SEC. on biotic medicines, Synlogic's of and undue is could the latest statements disease, of earlier various develop Form cautions potential expected other disorders. statements. with of range described those diseases, than the The and therapeutics development filings statements heading most the risk from limitation, or a not forward-looking you place the inflammatory of approach any develop trial in today platform to areas and the XX-Q press taking and future statements Synlogic's address in of or statements availability clinical Synlogic's as novel and synthetic bone, under to Forward-looking Synlogic's result materially factors, including metabolism, results contained regarding to Actual liver therapeutics cancer timing discover

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

Aoife Brennan

afternoon I quarterly to at expressing the Good opportunity am Synlogic like and company's about for in begin our call. how update Liz. everyone, to joining thank be first would excited on time by us this Thanks I you development. the important at

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bacterial of used response. Synlogic's immune to several STING make These is to system activation key first-in-class immune a In [ph] able activation an of only other via two the mechanisms, synthetic addition, chassis and additional pathways biotic potentially in in the be the agent. adding differentiated APCs, within stimulate also SYNBXXXX approach truly immune features magnitude overall immuno-oncology the

is SYNBXXXX study goal a scope to possible as of providing design or new study. in details second the file move calls. We XXXX IND to drug the and application on clinical to for the looked an as quickly future more half forward and into Our to as of investigational

period. we look have As you We've program can a see, busy XXXX. our it's to in made in to significant lot advancing forward been a progress and

financial to Todd, results like our the I'd the Now, to for CFO, call quarter. our to turn summarize over

Todd Shegog

good and Aoife, afternoon you thank Great, everyone.

associated those of with results is a operating both milestone $XX.X was now. in XXXX. which to collaboration close under million of As million the September financial The to million the XXXX, for $XX.X million for amendment today same third quarter the the released Synlogic's XXXX a XXXX. to in I'm $X.X of bowel you September period $X.X to the in of quarter-ended XX, increase for XXXX revenue after results were the were XXXX for treatment result Total compared for recognized the XX, in $X.X The million the third with September million $X expenses is of for of period same $X.X we administrative AbbVie AbbVie medicine and ended quarter quarter million periods of the agreement the inflammatory compared compared for $X.X and XXXX third XXXX. achievement expenses development in highlights compared of Revenues our the quarter XXXX. market revenue period the know, $X.X with disease. synthetic biotic review from third same revenue the of in primarily in XXXX develop third pleased of a quarter were to XXXX. and million the $X.X General third of were Research the the in for million million to for quarter expenses you

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

Aoife. you. develop important for strength now to turn the short-term In Turning mid-term a Thank ongoing in to million $XXX.X pipeline. our near-term and Synlogic we equivalents the call ended balance to data XXXX goals to back continue sheet I will investments. over and accomplish clinical to have XXXX as programs, summary, the we our the cash cash, readouts quarter of sheet; with advance and platform our balance third in and

Aoife Brennan

Thanks, we're for Todd. questions. now open Operator,

Operator

Schwartz Leerink line first from question And with Instructions] [Operator the Partners. our Joseph of comes

Joseph Schwartz

of I thinking in done to or things IND second and you're have of can design the it in undertaking the next what enters tumor on study clinic, dosing you studies you like before ask about you file the types talk SYNBXXXX; year? once to of the And the some things remains be half wanted mind? there that

Aoife Brennan

our I trial, several the finding So, material the which there and of clinical is between the terms are manufacturing manufacturing now IND trial think seen Number stages. -- in obviously opening undergoes three clinical one buckets. and work

best INR pre-clinical of alignment completing FDA is as clinical IND IND components three X will like. Obviously prior component in enabling component first potential give the sailing design is program. INDs. look the includes clinical our The [ph] the second third terms two study require candidate we to to us with the package the will with plan then toxicology filling And our final of which for that experienced the all new with Phase

that work making and great is So we'll be ongoing, progress.

of next is, component details I we with think on and your as in provide soon design In part of the work as plan the early that trial -- terms of on strategy, the have continuing and various and that the our we'll we're second additional stakeholders clinical to finalized question; year.

Joseph Schwartz

what accommodate administration? in if the And for of enough think potential about any you there tolerable immune from isn't effect then, XXXX an dosing that single do thought system a seen the Is about repeat would whether of manner?

Aoife Brennan

model presented So, to the pre-clinical data the the injections, apart a that. basing rate Paul kind and presented in plan of turn sequence days safety pre-clinically best we data line included pre-clinical of the that kind were and there that clinical the I that after the sequence that -- of model around that and we we're three optimal answer. from I'll that's a of mess couple over of of we injections leads The first send is to our what in [ph] get response

plan have reason bacteria learning's, done from clinical and so that on injecting Paul to So based others clinically other there. tumors no you add? the that the believe Anything time successful that's want that's now, to into what else the right be won't live and experience

Paul Miller

immunological from initial an so supports our a doses. experience confidence I exploring think we data -- will safety have response the think quite and but our we of that's dose, additional and accurate I we that quite bit far see

Operator

H.C. question next of Ram the comes line with our And Selvaraju from Wainwright.

Robert Burns

Burns Ram. This for Robert is on

are full-leased questions that if three [ph] just So data over weekend. may, congrats you I the on the all

levels. presented we at the intrapatient in regarding enter data ammonia one; variability AASLD an really the how So should them be thinking about first so

with agents Now kinds trials these for do probiotic gut? ammonia consume clinical in challenges variations controlled to of time the pose what

Aoife Brennan

we're think to lowering impact is the on our of for understand you how execute ammonia. a component ammonia determines plan I the optimal a and to way the set how sampling and that foundational is -- yourself perform study you that

underlines at I each presented and study, attention kind specific designing executing normal site, we've care that of put effect. AASLD the has to think see ranges to the and in we lowest most support data an infrastructure up give a individual the doing us the that we did and study this at set we possible variability to power

for past endpoint Phase early the And we'd after population the logical more liver So the gone and phase I we we ahead clinical so released say initiating think further foundation others, we've a think very study, and by hope in of each studies subsequent to we're underscored for in extensive us as posting learned I moving a that have of a as before moving I develop the many move think by it's that studies as can to at we data the will kind done intel -- an be from in way X ammonia endpoint disease site, I certainly trials; area and forward; creating programs. before quickly AASLD. as that's would gathering challenging a that been we X at

look would would I a of think So be and kind like terms re-through X there. Phase don't of that in up

questions you one? other first know two answer I your Rob; that had does So

Robert Burns

second with my actually so your a you one; answered is one this first response. Yes,

and I really can specifically the the within any readings? one that's So as processing granularity that extra guess you one; -- variability just within what provide sample to additional really, introduces

Aoife Brennan

think same loss can't further taken I difficult is the taken analyze a to gone haven't to and and well only truncate, very is it's ice; we protocol-based been ammonia that, we've be not measure, labile, with we're the think I step and just as on of of I a difficult, years every just So way and one known, discovered very very but hemolysis analyte samples assessment to in think will my the establishing be very working and accurately, time kind the in was has resulting physician it's the it from difficult it's a elevate the analyte to sample very to measure and from ammonia, analyte known that's the notoriously the so molecules nature it's [indiscernible] know of difficulty certainly it the field. to force well I fickle run a the

to what precise think establish be infrastructure think a I and to continues but most do it that we've the is way done I an to try accurate notwithstanding know, in challenge. possible, you

Operator

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

Mark Breidenbach

you A any enrollment for first? the if trial can the wondering cirrhotics; I'm couple cirrhotics sort on of of on liver ongoing trial delayed in initiation of questions based is repercussions the UCD there slow the on trial; the comment in in or that

Aoife Brennan

the indication. that liver equally endpoint of population. the the based there on based our had So terms this in of trial there a technical read-through fact I we've on UCD disease in the mark think our of to of initiation apply being UCD more for lot I solve ammonia lot A challenges even for plan remains the same and the important think would approvable experience in is of is terms -- some the staging of trials

from in apply there some be readout have some through and following is continue think and Haiti we I infrastructure can and be synergy and there So our do to continue we study. but around data our [ph] we learning only that to would UCD UCD to of so absolutely with strategy kind staged, and the they earnings the proceed what to

Mark Breidenbach

And challenge standard it has this more sites? guidance patients been of among the have in expected or your terms would you than slower all a failures getting just don't high the of in screening across set-up trial enough in enrollment baseline say is from primarily assay your coming of ammonia a

Aoife Brennan

to them generic in is the of in in ranges reasons of proper us to are to get we their fact combination start So then, cohorts terms they the just the that we there is the now the delay getting site and terms to trial first the do established before are of of two of ammonia FDA and terms running, patient; of paperwork there getting to now. is what site do and the the the up kind study real before right challenge specific that able enroll initiating a and were done, reasons that right run-in budgets contracting at asked each the main drivers a had

to related So it's not necessarily screen sales.

Mark Breidenbach

think endpoint is a population? what into you you the would response do relevant move approvable this earlier you more in endpoint I of in an a see questions want to mentioned clinically And specifically; in ultimately liver one that to cirrhotics

Aoife Brennan

this of our there and to think [indiscernible] hepatic and to of indication enhance options on open able obviously, the of have worsening population, the this episodes in I lot encephalopathy could continue cognitive endpoints Phase is to encephalopathy So functional we're that were I other X if also relevant we're they positive. to in in reduction a a work the but sure of be back that indication might to with of exploring or the precedent think to basis kind path plan of us approval data provide for approved do for follow, the hepatic before we that or have of number

Mark Breidenbach

AbbVie? what for on milestone comment you triggered Can $Xmillion the

Aoife Brennan

AbbVie color. I'll collaboration think [ph] Paul that more give can to you Marquee one, I the leading is and cover some ask and

Paul Miller

but about So that executing that strains the of we really bowel AbbVie disease inflammatory [ph]. it and against in program progress we're talked disease which we inflammatory haven't able suffice show we're of successfully that have merited with all and a against of that developing are pre-clinical models to to staged what say, components in bowel award partnership

Mark Breidenbach

yet candidates no in the clinic that have collaboration? advanced So for under

Paul Miller

this at point. Not

Operator

of from with [indiscernible] the Citigroup. question And our line comes next

Unidentified Analyst

Could regard to the STING about this product? contribution relative with and speak you're activation immune bit more little that bacterial of the you a chassis the seeking the phenotype in

Aoife Brennan

get actually the STING naked bacteria agonist, component into an the that we of and with In in multiple fact closer STING we the the other significant on can discuss slide to go. you both and the way by the other site that naked TLR-X compared molecule those that of presenting model in cells bacteria do when through provide action. alone. a delivering we certainly of of at cells interferon natural of getting chassis fact increase our we of start quite data, I bottom some second bacteria pull of doses showing a you is lot that in I interferon comparison of difference. some today difference so to contribution Type the just dose line stimulate in deliver have greater we context of is activation bottom TLR-X various gets to And you knockouts bacteria, bacteria happens TLR-X vitro information, of and interferon that to to But contribute the kind STING in I STING combination And that's think see the head-to-head STING that make a antigen further didn't what those apart The just a within compared function; then versus presenting the agonist looking is as detail the Does of a cells of STING but to the expressing same expressed the in of pathways sense? is, it as the you understand website releasing more that response, we terms of kind side-by-side I small and systems then sum how that can by we engulfment Type the potentiates really is STING. the Type and cell how of when line the the a much magnitude antigen those to that injects

Unidentified Analyst

multiple thank XXXX program so work data seeing then far the that and healthy then from biomarker the the based seen what you're And you've PKU; on Phe on it in and volunteer to to the for you. Yes, does, cohorts; you dose single clear range for in expect you the be dose is Phase normal X do that that phenylalanine within study? when fairly it the well that you

Aoife Brennan

see them -- what amount study for our may patients they Phe, if are X, magnitude to to significant in they that a in potential are or in able what think PKU, and I blood part we terms learn are consuming of normalize know going the levels, sense? makes we're we love bacteria the approvable the we'd we do, in we we endpoint clinically with there, with based Phe reduction PKU the and more is of Phe, be of currently that And but of don't to effect think looking I yet; to be with behave we completely patients program designed is get with what may how yet to in know PKU. continue the has calculation want of to significant bacteria right in we'll is patients as our we that think what program. What terms Phase a the as Phe already on ongoing. amount that consuming is more the meaningful would for don't we of know the now Does in be not the Obviously, acting is

Unidentified Analyst

Yes. Thank you.

Operator

with And from comes Piper question our line next [indiscernible] the Jaffrey. of

Unidentified Analyst

you those the see really impressed interesting was all, saw. you program; and by that progress the to with on I great was weekend, It immune sine here response

Just the follow-up answered, in cohort that what of that confirm; are treating just question, you're but the and Thank doses patients have mine a you're been kind asked of rest you. to PKU this whether exploring? and of quick number specifically,

Aoife Brennan

good ELISA to where XX same tolerability, would that forward patients if we days. X our in of of who they day For the multiple X/XX:XX protocol in numbers cohort dose would would of dose confirmation are volunteers would we a a fuzzy. upto did times the a cohorts healthy you X the dose PKU of do here X my I'm would looking whom enroll cohort, with we progress to patients PKU [ph] if in is for multiple and looks -- do we at but a know, X for active with dose drug get terms [ph], cohort PKU single and And single would dosed get then case plan be

that be the plan delivered the would So currently that's there. the in set day those are ongoing study and down

Unidentified Analyst

you much. Thank very

Aoife Brennan

any there questions, other Are operator?

Operator

no [Operator showing further Instructions] questions. I'm

Aoife Brennan

operator. Thanks,

the an forward platform. in potential future up; which give look in understanding for I think will date GI exciting us this tract. time the So and of we've We on XXXX built a just to year our pharmacodynamic insights Synlogic, directions I'll sum and of our this

for indications. be there thank all of of XXXX biotic the We cash joining IO the expect position find of million PKU second to patients making insights at follow-up $XXX both to financial today our XXXX. data all progress of studies, in and X/Xa in also any in disease into gain have first since position with activities patients clinical and oncology of human the application our questions. an synthetic IND if to candidates in current ahead develop ammonia, and us evaluate we you, Xb/Xa to We've [ph], around our in the of operator. platform you a like oral midpoint with solid our collaboration In and available We're in activities and treat our our XXXX. to to and the the XXXX. afternoon. third end And to we'll planned nominated approximately potential promise clinical XXXX medicines. We'll and good of solid elevated metabolic this cirrhosis Phase to evaluate in half execute with of believe later AbbVie year I'd the yield expect are the quarter, Thank we the our with Gingko additional program formulation across our on SYNBXXXX

Operator

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

Synlogic (SYBX) 13 Nov 182018 Q3 Earnings call transcript