SYBX - Earnings call transcript Q3 2021

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Operator

Good morning and welcome to Synlogic’s Third Quarter 2021 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 Daniel Rosan, Head of Finance and Investor Relations. proceed. Please

Daniel Rosan

XXXX Good This for press is morning outlines third operator. today’s us release available and additional synlogictx.com. our call. and section conference we quarter website on morning the you, The of joining thanks on which business Investors Thank updates. results our release at financial issued a

Other management our Brennan, Executive Officer; Chief will me this newly Chief available Q&A. Joining employed and during on the morning President are members Business be also Officer. Molly team Dr. Harper, of Aoife the and

call the our During perspective Phenylketonuria her third an to metabolic Aoife patients. opportunity on and recent return will update the highlights including and share will on Aoife impact provide portfolio. of the the provide a progress an then in update Molly will quarter unmet review on need to program our PKU and in

Finally I results quarter. the will our summarize for financial

open questions. remarks your the Following for we of will prepared call

now Aoife. place heading like call on or XX-K with As forward-looking results risks, the you everyone we differ Reform XXXX. the begin forward-looking statements I are assumptions, Form to to materially today to These undue are in forward-looking any Securities later under the hereof filings which the described subject Factors forward-looking Synlogic’s factors, contained most heading made over made would Act change And of and the statements those may numerous to over Litigation of from date any as Synlogic statements result the uncertainties remind under including Actual turn Private release comments earlier in factors, that reliance cautions in of statements. a on today as and would time. like those various to in from not include I or press could forward-looking statement SEC. recent Risk Synlogic’s

Aoife Brennan

XXXX. our our to update with you, everyone joining you us. set Dan. of thrilled for on we and Synthetic for recent XXXX, well the the prove financial we as to platform. morning Biotic you our progress quarter I’m began share results Thank When of Good potential out clinical as today thank third

We in systemic significant a drug locally generated the study. had and the thrilled that XXXX endpoints. PKU Furthermore, multitude across tract to GI asset impact plasma may believe also But that This This robust Phase delivered our a we’re in is concept a the in even biotherapeutic proof our stop do we’ve intend opportunity of the population. evolved first an time have to Synthetic activity. SYNBXXXX and SynPheny alignment that a to Phe on proof concept the statistically Biotic we not has And a first more is reduction clear therapeutic that our disease a demonstrate of done Phenylketonuria lowering levels, Phe by study robust in in example report X history is of PKU. demonstrating in at platform, Synthetic levels. Biotic of we just the demonstrate Phe lead of development demonstrated

function chronic of for who from to over to substantially hyperoxaluria a oxalate be has a meaningful therapy Enteric says, the portfolio reported of Enteric by as product the suffering our robust risk measured Kidney significant to indications. SYNBXXXX disease in metabolic GI SYNBXXXX we the both incident multiple demonstrated patients hyperoxaluria, candidates as increased result does weak progress past damage, it with we In fecal has Nephrology week, also reduction. in of kidney potential as as the urinary a building at over robust oxalate be We’re of renal Society shared tract time. the insidious consumption American as quarter oxalates and

on study XXXX. that of to continue the prosecute will concept report of data in in and proof We SYNBXXXX patient

the inborn also HCU. to call homocystinuria SYNBXXXX. unveiled the tract our speaking metabolic more the of oral degrades with extension at Bioworks program, and work in metabolism third our partners in an and natural as We’ll advance an proud SYNBXXXX of which the prepare and be PKU. of our we or HCU a treatment in this We’re program timing we year. file have IND week Ginkgo GI error about is next clinic for into for this

immunology advance. by pipeline to nacent also continues more Our

medicine of immuno and activity that start with look oncology to-date approach forward is to excited Roche arm SYNBXXXX SYNBXXXX new the develop bring of IBD We our however, phase sharing in study of further to to is the our patients. for we first our with on We’re have week. Biotic treatment Synlogic off on also the programs, our milestone this not X to a platform, that promise well-positioned a deliver collaboration enrollment therapeutic be later will meaningful fast resources completed anti-PDXLX. achieved is study combination focus a continuing of we and at with time. of Synthetic the a comers order already on In to this to studies old all

on We niche patients executing restricted ways cannot. modalities can a rare approach tract are other the to on diseases, in where targeted treat our and metabolic GI strategy, focusing

a to the Molly pre-commercial share launch the of to with experience PKU. Molly need unmet comes her to welcome development thoughts Molly we Harper us and Now pivotal States in our and and as the wealth moments a at her to And build both rare over capability let to broad few team have on we you. her in looked PKU. in thrilled me globally. are diseases United in give

Molly Harper

Thank at the before to program the Synlogic that opportunity those some affected with those PKU. initial delighted exciting and remarkable this team, share join us Synlogic the you, observations I’m by living lives incredibly particularly advanced we transform has time. regarding potential a to to of momentous and Eva. It’s with

a paradox. As and by something for the affected disease the presents of community PKU a disease

well research taking as since a and and and a a for and disease rare well researched. There specialists sub and characterized advancing community progress. been lives. seen in the is clinics. and is as are with well clinical clear well research PKU at States about sizable defined as every and dietitian are have United point their a care it It via medical are links advocacy specialists There ICD-XX There’s person this straightforward population are has provide experts who has newborn dedicated ICDX hand, disease networked passionate specialists who some diagnosed been codes. countries. that one There diagnosis population. many a for extensively it both or the as on screening community who universally So is has to vibrant tremendous the those been born In well PKU clinics. The XXXXs, have of implemented is in

therapeutic the have regulatory multiple been On clear protocols There approved. There side, is precedent. for drugs are reimbursement.

different among as their burden often we Much generics about caregivers. those is of devastating trial of analysis medically, connected populations there eight reflecting which that study, yet, and patients remains despite that fold or well for limitations for even complications living One the comorbidities, The that disabilities, greater periods treatment continues socially, truly and the documented, are with burden show showed a most response. clinics. to well disease these those treatment who despite level; and based what living are on with these PKU specialized of affected still through heard one this were approvals, of significant empiric enough therapies determine these now psychologically, transformative our clinics XX% disconnected large and have not intellectual is adults diagnosed establishment comorbidities, for claims ensured, a of of such an PKU every of a extraordinary drug that is XX% PKU disease of focused economically. be on XX% neuro has found that that patient facilitating to study And receiving those to perhaps has psychiatric not risk is these and with multiple attributes, is with

case. FDA would be why multiple to understand this with So it’s drugs, approved the hard

majority This day compliance experience on a renders advances, that modest relatively mild decrease. represents Utility a to required limited XX% is negative “mild pills is of which living of Looking a all PKU additional some of can left a unfortunately Phe people generally intermittent about action. just XX minority is restrictions, closer, This With comers in while for mechanism to of The this, top conducive patients. and at treatment option. to risk discontinuation. PKU” important, XX% those and approximately reduction respond does supplements. living that dietary these have the burden of needed need with be functionality group the that maintain of with

note manage who moment characterized those by which PKU or who persists options treatment something which that of offer and PKU normal of eating For one Phe as lowering, year this what population, granted to the therapy, for this it’s is which in social for adhere life. have capacity have box makes additional most who at the significantly as Injection us provide take desire for been great can and extend important those classic even vigilance can underserved living It’s advocacy closer injections, more and But titration the up adults people a requirements does risk a adults. anaphylaxis drug severe and to that population can of the with or there’s any for today. and both the both to majority the who over warning. the to those a dietary those calendar through daily the most

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list any the the PKU to potential designed Phe of conveniently cannot metabolize with Synlogic systemic a able via those PKU Synlogic for to these been orally has and in has in efficacious. from The cannot the potential mind, one to listening mechanism option. locally new to to package tract. dietary administered, treatment that delivered with with more metabolize greatest would associated actively has Biotic is worked years intuitive. mechanism approach PKU the in Synthetic Designed orally People That And be use in protein. the predominantly the The we need. with team administered safe, name. recently risk. GI a would biotherapeutics So view Phe and be with Synthetic community address needs wish enters sharing now, several convenient, potential have who their absorption, been were consistent share for learning Biotic the which early this exact an at dietary without dietary how be

So ask me now through that to share been we’ve clinical take you you data able let today. to the

Aoife Brennan

Thank quarter, program. Molly. you our which this gives in Earlier two datasets PKU us we advancing confidence presented

study SYNBXXXX. and phe of suggests, attractive into profile. target to that study encouraging head PKU of in consuming patients of study. trained secondly, are Firstly, data, on we these in activity PKU head two of eight even clinical found and more healthy blood an to in may be pivotal that and X the data. SynPheny analysis SYNBXXXX a will reduction phe phase to Based our an is with we achieved X adding SYNBXXXX for available phase a interim volunteers. provide We our program SYNBXXXX levels advance approximately highly SynPheny fold two with preparing SYNBXXXX PKU in the optimized And patients comparison phase SYNBXXXX a in This

complete sponsors liter repeat diet population strict eight recall, and patient is patients population SynPheny and which had their own has phe run were match phe An baseline The we a population is intake than a They in a PKU. is that you therapies. first Subjects on not with remains classic The doses shared study, by XXX by of day the data [Indiscernible] out screening design single levels in critical washout per to important study the at study. assessment. available ongoing above Micromoles a throughout management been open This trial this to X which a increasing received control. from As has to phase of It’s each was then assessments. more the endpoints the and maintained placed was period. XX There two our severe their BHX element interim designed that the studied. weeks, to diet with followed study were usual served enrollment. in followed two protein SYNBXXXX this by assessment, treatment functioned in arm diet as on over patients

First and test period was dietary prevents of standardized the phe challenge SYNBXXXX beginning to determine absorption. phe unveiled here which at end performed containing breakfast if dosing labeled called a with the

on evaluated dosing and at Second, day XX, plasma on washout of fasting phe. seven was XX. part measured again we after end day days, period This the the

preventing is highest cells, studied. test purpose at the with was the begin In after dose phe. and DX the meal XX Let’s being containing breakfast underwent Xe of the XX The from phe and their this to results. metabolically phe test it blood absorbed GI of a tests, subjects active SYNBXXXX look metabolizing which these first standard same challenge whether on tract and meal challenge and dose D-X day They was a received increasing in then on received levels. the

phe or activity, the of breakdown biomarker On the hand it’s panel byproduct the left by TCA shown in strain. blood the because strain is increase

it can dosing. expected, observe that significantly As with increases we

baseline, two is blood reduction and GI basis next is amount DX curve compared patients. key PKU as approved compared on and to It’s baseline we metabolizing When the indication. under On Fasting whether from also guts. bar previously This a in XeXX by to by confidence XX% right percentage over of the first the phe in in most absorbed tract or use reduction to that critical was question we production at live was they’re manage think whether phe hand the phe can intervals. blood treatment those and in physicians periods of to this weeks observed of represented product fasting SYNBXXXX change of levels phe DX panel from combined in the cells. which mean is with be up of patients which observe XX% the that phe levels. measure of XX% it the absorbed actively they baseline a in treatment the the FDA a this in the The blue the in the impact indicates about dose phe titration dose of lowering blood blood went The TCA with levels meal. endpoint phe and is not approval graph with after before the control. phe disease, SYNBXXXX the dependent assess The we area with

to observed a represents XX% reduction bar the XX per dose The baseline. on blood second graph blue phe this main we compared

indicating Importantly, the confidence intervals just was that here do not cross this decrease the significant. absolutely arrow

relevant comers In blood analysis of the XX% the phe responded to a a KUVan. clinical will XX% be procedures, with blood see of the mean the an approach approximately stopped relevant me in of diet damage phe a bar. it XX% SynPheny gut particularly predict to response It What short, Biotic to which in likely levels, an the and this treatment you is our an blood reduction, to X research happens what well comers confidence intervention demonstrated can the in patients effect to impact coupon from its defined set what this slide, driven all break XX% on prior population. One the patients has disease all does indicating plasma matches critically, very which was that phe it is phe therapeutically mean? to SYNBXXXX, the in we phe thing biomarker patients. endpoint increased, with level be taking levels observed data our as on data the of means of increases field, been to interim on In compared mean exciting PKU. Finally, Synthetic phase a doing lowering including a achieving to blood prospective when means first have blood represented sufficient our expect in pink level our that therapy half by lowering. could a acting reduction treatment down this Despite trial, SYNBXXXX. that’s that we it that time clinically PKU, modeling, analysis favorably for and decline is study phe is Also, showing continuing patients that phe do, shown management, the for in the

and related and a GI no are and were in to action mild observe strain restricted Finally no prior acted and we predominantly gut our our and manner consistent SYNBXXXX discontinuation. with treatment did in in severity safety, importantly volunteers. events adverse The there related moderate adverse events the restricted gut serious of healthy experience

we’ve in Nature developing been three product dose SYNBXXXX healthy developed Now, and potency we phe know, evolved was published the demonstrated candidate, we recently as the an SYNBXXXX. study of we’ve SYNBXXXX X using first two cohorts techniques, Communications. volunteers synthetic which you and advanced also biology Through have called phase which more things.

we activity metabolizes production indication dose PKU manner. SYNBXXXX biomarkers, DX rate approximately greater consistent at that metabolic with and program it we has both was two of and the was between the First, find consistent in at portfolio When SYNBXXXX. activity SYNBXXXX, This and and than for that We SYNBXXXX ratio plasma And that phe Synlogic. approximately secondly, also TCA think dependent SYNBXXXX. findings phe the so SYNBXXXX, preclinical this at studies. in calculated the twice does that of fold broader exciting both across been of

in challenge and seeing phe previously and SYNBXXXX a caveat. a and volunteers, comparison in meal to meal usual with Nonetheless, compare important which patients? the profile Of these expect rapidly Upon the the we becomes, SYNBXXXX hand, the X% we why SynPheny is in translated study, into One in the of patients, will reduction strain improved with in SynPheny With question advanced we Because to profile platform after But SYNBXXXX multiple how DX is of study for conclusion product post PKU of days XX% study activity data. confirm observed note select profile in to implications potential activity SYNBXXXX our SYNBXXXX patients. assess we XX% with diseases. the clinical development. this has improved PKU the asset other to its enviable exciting SYNBXXXX our which meal a the the we lowering the of potential assessments on to in groundbreaking across SYNBXXXX will the greatest way volunteers the the based phe fasting reduction potentially patients. inform translate minimum in into will With efficacy. a clinical has PKU differentiated to our on and only healthy PKU in a meets activity is its position for metabolic assets. in having we intend labeled an based new from phe arm advance advance are Validation viable post pivotal between a healthy datasets control which

at are the surgery. and formation loss to is Let kidney as efforts alone. hyperoxaluria, me nephrocalcinosis weight bariatric with Since surgical provide in which untreated, levels treatment devastating a briefly updates on oxalate left urinary to oxalate serious hyperoxaluria. Enteric often insult resulting short dangerously cause which the damage healthy oxalate condition often urinary we bowel such in HOX lead high to disease, a progressive dangerously of as recurrent It procedures a kidney almost leading such are result progressive disease. of This bowel fat syndrome primary If high stone result patients levels bowel Enteric kidney that control hyperoxaluria inflammatory in no as impossible call option is risk with for of diet foods, in to complications. occurs Enteric our present kidney chronic malabsorption, damage. many means of is

of of of standalone States. is options living platform patients overall XX,XXX who the believe hyperoxaluria the in disruption disorder. in They significant also kidney For who chronic of oxalates and and patients in an meaningful syndrome, to short to stones recurrent and or of risk face is Enteric isn’t the damage of stones In this have new complexity clinical approximately a biotic provide imperative challenge problem, bowel chronic treatment and it absorption recurrent XX,XXX the chronic Enteric practice, pain This bowel high result already kidney the have with hyperoxaluria is significant means most challenge today, care. because patients devastating a kidney population, with stones. have pancreatitis underlying pathologic IBD, are a no we United kidney approach. the and this There patient could recurrent

to reduce the as potential additional XX progression is in the degrade oxalate providing an to clinically of to or has may we including tract. manner with in you converted oral the oxalate risk GI the baseline intuitive was this urine phase biotic dose. to in with study, and nephropathy. the at a is levels our this from for We oxalate and oxalates in XX% into oxalate eliminate the girls only hyperoxaluria the recall response previously showed only so SYNBXXXX simple oxalate meaningful able dietary excreted. synthetic significant concentration year. oxalate consume Xe of proof oxalate of we we that analysis the a are relationship. is reported metabolizing of and substance much in week XXXX. measures currently progress SYNBXXXX lifestyle robust part placed change one rate to of fecal We that can do throughout translational levels the toxic oxalate modeling. GI in of which that efficacy is the approach develops program phe XX.X% tract consistent approach medicine patients looking this are with mechanism phase the This Lowering way SYNBXXXX consumption metabolizes Our study reduction reduce the than other dangerously at The this demonstrated urinary harmlessly fournaise hyperoxaluria GI A responsive data as of compared oxalate consistent Kidney at placebo with dose the significant reduction high lowering a and activation enteric tract greater is is forward which month the earlier is earlier and X demonstrates percent ASN because level amount of dose at in both at of The disease feces excretion demonstrated finding

me to Dan? run briefly through let call the our over Now, Dan to hand financial results.

Daniel Rosan

the as This and phase released the for associated Bioworks the study Ginkgo review morning well you, SYNBXXXX of our results the of quarter highlights and collaboration September activities for ended I'd other we optimization phase XX, study morning Research XX, to third compared everyone. months primarily and SYNBXXXX XX.X in expenses clinical Thank now. for for with $X X corresponding expenses with September Biotic of development results XXXX. as those compared quarter financial ended the million the XXXX costs XX in were General $X.X Aoife three related for medicines. SYNBXXXX to with Synthetic in XXXX. SYNBXXXX to you X million same to and well the of like and the XXXX and consisted the administrative third million as were good initiation as study, of period our million expense $XX.X the period R&D

novel loss third XXXX discovery compared share or for of period a in net same of XXXX. for per the quarter bowel Synthetic the for inflammatory was Biotic to the medicine a treatment of due of for for million initiated Revenue the loss the to recently $XX.X million no revenue or Revenue with was collaboration of the million, Roche net of corresponding third the XXXX. XX $XX disease. $X.X For $X.XX to the quarter a $X.XX reported company consolidated compared in period share, per

XXXX. calls. equivalents fund our into portfolio. future with up. Eva attention. be We Thank million balance we some Now investments the clinical the will to I the to current over for advance call look This in updated keeping cash cash, expect to as XXXX turn of cash you wrap forward short by XX Under sheet. to term This operating your company and across through our buttressed turning our will equivalents XXX.X to third you now plan, enable financing. ended readouts quarter compared was recent programs Synlogic metabolic the cash XXXX. our to to XXX.X data sufficient logic important on million December and of will the

Aoife Brennan

Thank you, Dan.

progress Our both clinic. metabolic across to all team and PKU for has We patients other tremendous executing sense in to look a and with the therapies continuing forward serious effectively urgency. We're meaningfully programs outside with diseases. advance our of made

the We questions. will open call now for

Operator

Thank comes you. from line Chardan. of the [Operator Instructions] And our Keay first question with Nakae

is open. ahead. line Please Your go

Keay Nakae

Yes. Thank you.

little And the bit further HCU? the compound if of here? can you specifically, XXXXX on your market newest Just wondering a comment size opportunity you characterize could

Aoife Brennan

Yes. thanks I think we over to I'm advance because Ginkgo just collaboration being into move to to high about Keay. and an get of point ready this going to exemplifies we've you compound the to quality leveraging to the that turn to research work programs rapidly IND. talk in the done us Dave how are it our stage to with

in size of population early market make of comments on and sizable So I the that a the program. need think need there's that's Molly, to opportunity, obviously, in unmet out, but a of a we very a exciting element of there terms substantial days believe treatment. that And mapping then of patients there ask I'll do couple of

comments ask to I'll on make So that. Molly some

a over the of the to on couple So side. research just give to Dave highlights first

David Hava

Yes. happy do to sure that.

disease lot is a of elevated approach. based where and HCU pathology patients think a systemically that have So drives with levels, we that homocysteine a can we address gut

So the homocysteine from thymine. is generated

thymine the a conversion So prevent homocysteine. in engineered have a is to we way a its ultimate absorption of to SYNBXXXX gut, the what thymine as consume strain in to that's

from that And a probably towards and sounds to that platform certainly the program our the phenylalanine. PKU able lot approach It's we're PKU taking familiar. with development a the leverage advancement we've to SYNBXXXX. been similar understanding very of of of So and the

program collaborated the clinical a where mentioned, candidate. also is this As to Eva ultimately on and have land Gingko, we

the of And and of base so that went molecular kind kind that chassis that to transport was that base into components identifying namely, into some the the of then we've using and components and thymine it of involved bacterium, Gingko into enzyme developed. putting transporter we're and the organism discovering our in break that strain, kind down

IND what been into that and enabling studies So in we're and clinic. PKU, think of of into we it's advancing to And and story. kind really nice extension doing the that building upon we've looking forward a then kind

speak Molly, bit to market So more disease. the the a you and little can

Molly Harper

Yes, sure our technical Dan. of in opportunities. commercial the similar therapeutic side the from terms And synergies the side, Dave's I think comments on on building about it's development op

it's well some in distinctions ways. PKU market, we of interesting and terms as So both synergies in really the comparisons, from think as

the already really the points, PKU same are I prescribed to is is of and due or consider and challenges exact of attractive. current some exact call market very our even perspective greater It's first and terms that's the a But as think, in need opportunity synergies base as to unmet the cases, in in same point is burden, that company current the a contrast, to therapies. a fairly prevalence lifestyle, similar underlying as been in the opposed interesting, dynamic rate in where in PKU, and market very The situation diagnosis right to homocysteine therapeutic is now. really We're defined potential. terms the area quite diagnosis. it's has is of down historic And come different. increasingly. the the learning opportunity it's other to particularly just interesting are But in that assumptions terms for

about convenient, forward that from opportunity to also they're could community, this similarly very, we something orally be the that safe, PKU, excited and for administrated very looking so clearly very is tremendously efficacious, And therapy hearing are much to. and

diagnosis the or for the the attractive is situation, and very investment a and opportunity of that synergies and market rather, So lot a we're it current But by is there's way, in driven us, about in really awareness. size potential there our development very same most given potentially, of terms thinking time, dynamic there's of PKU. at

Aoife Brennan

Yes.

this here. is clarify, to Aoife Just

may Just diagnosed PKU may proportion familiar element that hate not of for because you to birth, to Molly of be patients see for with newborn but is familiar in not with a you this screening said, XXX%. those not clarify what it at are HCU

their there So a who stroke they with homocystinuria, diagnosed of in their are substantial early when actually patients proportion teens, are XXs. first have

later patients. based of estimates of So for of very the bit catching variance patients screening that the diagnosed of are HCU, because all test the those at epidemiologists a around prevalence test not at variance birth little XXX% patients a little is terms there's because there and reason, diagnosed precise because on kind prick prevalence more in heel newborn PKU those the is

So that's disease. the with familiar just for those not

provide Just wanted that to clarity. additional

a question had Keay, you as Sorry, up well. follow

Keay Nakae

Yes.

achieved Just milestone. Roche first wondering the you the mentioned with research collaboration respect to you

others So over milestone the next Roche under you do step to far reach clinical you first development. take it once collaboration what it pursue further is for hand this before program, or that the how to essentially you

Aoife Brennan

Yes.

a bowel an discovery the is option other our are the Similar sides, collaborations, phase were has this first disease. in ourselves of targets by there milestones achievements exercise similar that in in that still single our what phe And with of disclosed filings. number are we happens and So a been both both followed think option, inflammatory milestone. to the I subsequently much pleased negotiation things how as Roche to going the very But is progress. collaboration open with very

there And as getting initiated we're quickly, having the inflammatory platform some think, real about has bowel our excitement positive. using a year, we in think been So this disease. collaboration earlier I

So between great established relationship and think, done testament the great companies. work I and a both team think been his have I Dave to a

Operator

Thank of you. from And the Leerink. comes line our SVB Schwartz question from next Joseph

ahead. Your open. go line Please is

Unidentified Analyst

Thank taking Hi, PKU you one I'm questions. first for for is And the Joe. the on program. our Julie

remarks, many are mentioned market you there diagnosed in patients As be PKU who but are penetrated to are not your prepared appears treated. the under

strategies sponsor. your drivers more opinion, commercial currently employ market could to key penetrate do in a one PKU So potential you you you by believe that's about are what for little adoption? the bit talk could Maybe dominated commercial the

Aoife Brennan

Awesome. a Molly. sounds Yes, question perfect that for like

it just to, provide Molly's some person extensive rare and pass I'm some experience a jury, provide with challenge. perfect her the her sees to ask opportunity. going the in of strategies, around So And obviously Molly commercial plans around to disease the how I'll she I to color meet additional call her we color to think this

Molly Harper

consistent a to and here States, and countries of rare awareness. And also yes, really interesting a So right. described that the and high there's diseases is degree lot of United strong in you there's sense really compared recent as earlier, the very other are in diagnosis, most launches

area awareness, of things course, disease and in it's to a there other of efforts unlike of tremendous where situations, So like be, terms lift actually an that. needs not lot

was interesting, very this So what is really low picked rate. up you on treatment

hear really it while we the is and what approved of been and we do as the long are that, So lot treatments have why therapies, that and two is and first basically the a given consistently, available, sense inherently mechanisms. makes how they're there described, inherently sort, limited,

mechanism will that on it's out disease, diagnosed finite age is two every minority, the there's a PKU around But for. that of minority therapy universally there's their important basically, person underlying of work So so. to know that group patients with or based a

not lack availability the also community really point it's and out but rate, in in is convenience, consistent those of a really today, what can work this market, for treatment inclusion of wide safe, option. awareness fundamentally treatment all the And the administrated, need be patient testing, been of left that a available orally and been for just why for that's terms how and clinicians option of have options both it's So awareness, can new range it's a patients, medical in but low exactly remarkable describing about points. viable community really where of you remaining that the have

Unidentified Analyst

development Gingko set on stage the potent my then at but your you. you you means gets drugs you that your preclinical think maybe many the through Thank question how more develop it then more do in doubt very How time collaboration with platform, No broadly the Or clinic? much. is your first the up? try? the collaboration? from could from expect programs other great. Okay, different second And more different can Thank is XXXX And we in programs Gingko.

Aoife Brennan

closely Gingko That involved most sounds think because Dave, question the collaboration. the research like in perfect person the a I he's and for

this? you kind do to Dave, comment So of want on

David Hava

Yes for sure.

the built in and of lot XXXX platform. of programming part parts a the between and PKU as similarity terms the the understanding tools of molecular a our So we're leveraging that some of programs, we've of lot

the the and switches, types molecular we're promoters for that using we're of using same chassis the regulatory So purposes. same we're making organism, manipulations same types genetic of

through out programs. up potential and how of lot we how doing, platform core pipeline stage us and speed A started So and clinical the everything started behind we're that humans. helps that's learning our part of that their in we're that the the activity we a also organism predict threads building

translational of that translates the the and to have all to that So we've activity capabilities applicable. model predict types and of we therefore impact strain built activity is predict in humans, might

down pace allow The really drive programs. we have does very is programs that molecular so the we types of might in. And for with SYNBXXXX. is with that slightly that be. across us to earlier different fruitful the collaboration so faster that transporters will that phenylalanine, stage biology thing the this the break interested than continue at has been the think specific So are a for and Gingko some the example, go for to than where components we're enzymes

they way components enzymes, the our So that approach, have different the examples, them the were and with and as identify and improve able ultimately into transfer XXXX, so to strains. to to activity real for us components, they both allow that engineering of enzymes, deep the databases through to components working a some capabilities strains building clinical effectively activity is we're screening better transporters, those candidate. screen of for find or Different might us those some to,

can expertise We and those great focus going into what don't constructing biology kind build. for of on build that clinic the a translating to we're underlying the need and out the can really that that of it's candidates, clinical their then thing candidates after. So on we us, and the leverage focus internally. the We mechanisms activity they

with you earlier maturity programs. really that similar on as to-date. working get emerge we level we're those look a great And it's them will updating So a at And number all on SYNBXXXX program. of a and been to on of collaboration other stage forward to

Operator

And from our line a comes you. from Raghuram Thank of H.C. Selvaraju next Wainwright. from question

is ahead. line please go open, Your

Unidentified Analyst

Good Ram. questions. Three for morning. Thanks taking This is me. for quick Mason on for ones

dose observed you on kind So previously of XXXX dependent reduction. of effect SYNB this phe

data XEXX. versus seen to we've the XX% the compared XX% reduction So dose XEXX with

As perhaps your color pivotal study? you to range towards to doses this widening when analyze provide any into on you you go data, continue are able higher dose

Aoife Brennan

question. great a That's thanks. Yes,

correct. absolutely You're

across into the have nice relationship our We the clinic, that dose biology, all and a confidence in which us response hitting we're programs, that that we've of gives right taken really this drug response. we're platform was effects achieved that predictable out with what based we like making development seeing traditional really bacterial set platform and to pharmacology consistent achieve fact we've a and dose

strong really platform. of underlying our a that's attribute think I So

strain program work for how better continuing rather to dose I enzyme more activity In is do the think can constantly to looking on right, terms the cells. for what that PKU patients. absolutely the focused And actually we've cell, has of of you're than with per increase we're

we've So that's XXXX. what done with

of by apples activity the apples So see get XXXX. to XXXX dose we for XX that actually to amount

that healthy we exactly behaves about really meal meal I in amount see think in in to and the healthy we levels that able volunteers predicted. see blood nice a reduction after are after of in Xx We biomarkers phe as this volunteers developed challenge. terms of

So we believe that that patients. will also translate into PKU

from So cells. maintaining number dose of of it's potency the increasing same a while perspective, the it's kind

strategy and response optimizing likelihood of clinical the comment our individualize the that product second the make making and at would look of phase to our X think the terms the I based their I in kind allow both their we're profile patients around of is to treatment. will sure on study tolerability is

needs there's so for terms recognizing patient, to some that getting that the different likely flexibility each a the the and it's that but that can their a there dose, way we in them. that's there there for each that dose, on be single of will outcome can optimal best where the right So not will be dose patient a adjust patients be achieve starting technical likely and physicians range based and response. And to individual dose we that dose on patients believe have then

both the make program. So really a as our this both will phase as around XXXX think that dosing achieve profile we X end Does individualization interesting at of well sense? flexibility and

Unidentified Analyst

you look quickly. code advance to for That's capability candidate all absolutely. gears was going throughput able Yes using great. really are interested I selection They base SYNBXXXX, Will the to yourself? future collaboration candidate you lead Shifting relatively with be in generated high the this testing to to similar candidate code or base. were develop Gingko, in

David Hava

of to we're as no that as the I there's XXXX. I mean, we replicate internally. for out Yes. for many do is proteins for of the into around I genetic both think for we engineering, is which with to Other libraries them. approaches, we've search look enzymes with I other protein building and employed that mean, mean, like built, and database capabilities is would can base, and and the also kind and we that come something components I what that us databases need has happy with it valuable. material come that identify programs specific code And interest can can future. with and think of really

into translating be our continue would the strains the expectation really the the clinical And, again, underlying internal we efforts would to and in development. fashion. on and the their biology focus the so of really activity candidates operate translational And aspects construction that clinical of early

be it So we going would expect very similar to forward.

Unidentified Analyst

the Thank Roche any partnership? just to addition and able opportunities in further in reveal term, news near the you. Gingko And of any partnerships, are finally, you to

Aoife Brennan

already to absolutely would If that. we the done We the That answer know think partnership, I we hadn't anything. wouldn't that disclose wasn't disclose final. you question.

and programs internally. consistent So which very been the we pursuing are answer these our to we've overt metabolic strategy, that we're is, is no, but about our strategy

interesting We then experience focus our pursue our in on our core candidates continue to of PKU opportunities strategy the to diseases. leverage that metabolic of component second advance and to builds really outside that and is platform

recent journals profile publications our progress that some strategy. I made with opportunities that the Roche the high for and platform other of we've think exploring exemplifies exemplifies

if to pretend opportunities to changed, to that will continue execute hasn't So make strategy our pursue changed, ability and sense. hasn't

Operator

with comes next Thank you. Instructions] question of Oppenheimer. our And from Jacqueline the line [Operator

open. Your line Please is go ahead.

Unidentified Analyst

Hi, for have We Mark this few questions. Oppenheimer. is Jacqueline from a just

I in the Are XXXX regarding PKU. is with know been able year? you've in one pediatric run about first demonstrate to next safety. trials parallel you considering The study

Aoife Brennan

Yes. question. great That's a

you who big I have outlined here really the no is opportunity pediatric in prepared opportunity oral there for her remarks, product in to an coupon intervention. population think rightly a don't as respond earlier therapeutic Molly for

on as that more plans we there as regulatory as as us. soon those market about discussions our pediatric a you'll see for we And be key we'll that hearing development and get progress. So just be alignment so pursuing regulatory

Unidentified Analyst

can XXXX into most all the to for year, of next demonstrate go clinical the in what right a and you Would program? also, bypass in steps concept assuming want study the likely for pivotal be proof Thank you next would you gastric population?

Aoife Brennan

Yes.

into I HOX have But to program do we we've proof a concept the for question there bariatric So key would the opportunity. chosen expanding be plan think expand into we for surgery the other of population etiologies. underlying

making pursue. I similarly across is a I statement the is of that etiologies sure efficacious something think goal possible, at indication we mean, an range broad as to as product underlying will launch. that So our is have

under go a the of still is of how out discussion and kind proceed concept we of the it's depend coming two will, on clear to or phase internally, of two proof study. whether think to three, phase data course, a I directly

Kidney meeting making on going development inform week, have of week possible that also of think best going with presentation I using decision nice forward. make evidence last kind had the how at demonstrates for We ASN evidence clinical the world really world a the to program generating work will just We some real kind plan. sure we're we're that real the

patient of the well apprised absolutely community continued the as make on and proof the of decisions. but we of investment key opportunity the inform disease from of natural I the understanding our the will the So think the as data segmentation really will those both keep concept and some history next the program, step as

Unidentified Analyst

Alright.

also good. regards Sounds is last question our SYNBXXXX. And to

market or I there XXXX collaboration got no. with umbrella makes internationally us XXXX and think to if royalty the if under the can you is But if the remind falls is milestone of Gingko commercialized? Gingko so, to answer the your any obligations

Aoife Brennan

Yes.

we collaboration, was inside actually that developed signed zymogen. the had by subsequently So -- before collaboration it not enzyme XXXX it the with who that developed with we actually and technology, zymogen, the was Phe enzyme, a become started was Gingko XXXX, it

I further candidates make does think And milestone are the strain. they a, involve that's we're we downstream in the we, really very provenance It's collaboration or so their stake ownership that just any as There's the obligation part collaboration. our no you, but full have kind equity best And of rights. getting an and to with Gingko Synlogic have possible that Gingko incentivized in of commercial to to remind sure company of stake not to royalties.

Operator

a have we up from And Chardan. with Keay question Nakae you. follow Thank

Please ahead. Your go line is open.

Keay Nakae

Yes.

more new ICIEM. the not that about up per just se? at perhaps Is include a going coming patient detail, but to Just data question oral presentation any

Aoife Brennan

presentation. of but be principal data. our Correct. presented earlier It's are investigators press just in of trial, year. it's we release press -- the been but conclusions the of Yes, Obviously, academic an remain will you're the and included be would key number presented as one color same. this by the and I be Jerry, with patients will a more interim, on more detail that it the our release consistent think it's that And there part is

Operator

I Thank would you. And this I'm Aoife to over any conference like for to remarks. time. turn showing the And no back further closing questions at

Aoife Brennan

you updates we Well, for to morning. next everyone the us joining share go all us that keeping informed Great. to as we've into been thanks, forward we pleasure a and had our across It's year. programs, this look

Operator

call. participating. conference This for concludes today's Thank you

great a Everyone disconnect. day. You have may now

Synlogic (SYBX) 10 Nov 212021 Q3 Earnings call transcript