SYBX - Earnings call transcript Q4 2021

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Operator

Good morning. Welcome to Synlogic's Fourth Quarter and Full-Year 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. to Investor call Relations. like Funderburk to now Kendall of would turn over the Andrew I Please proceed.

Andrew Funderburk

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

Officer, Molly me Michael President Executive during Joining Other this and Hava, management Dave available Dr. call Jensen, the Q&A. will team Officer. and Chief Brennan, Aoife Harper, Chief on are Financial members Officer, Officer, of the be Business Chief Scientific Chief

update During will a Michael in need fourth patients collaborations, a program earlier the and highlights medical with share to on a PKU, the Dave and of and stage Molly will PKU, an to perspective address review additional our our will provide opportunity overview. financial Aoife discuss on provide therapeutic option the and provide programs meaningful will lead and call, quarter her including recent progress,

Following our will prepared for the remarks, questions. call we open

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

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

Aoife Brennan

or Thanks, I'm our disease inflammatory our thank with you for full-year the program our Andrew. us. SYNBXXXX the to updates dramatic our and year. bowel initiation HCU. commitment And on progress, Phenylketonuria of candidate and Good for Enteric team with with recent research well Phase with PKU. mechanism advance from homocystinuria joining for disease. In Synlogic And share collaboration as to lead for this Proof-of-concept fourth-quarter or across SYNBXXXX today, portfolio. progress XXXX. to in Roche with a results of thrilled as morning, XXXX the everyone achieved you second rare Proof hyperoxaluria, metabolic a drug III financial

now advancing are all proprietary product a candidates already We advantages diseases based engine. differentiated, clinically the new for of drug our on pipeline metabolic and reproducible administered of

in this our our data by And program We proof-of-concept are to continuing in this the from looking expected initiation year. Enteric forward XXXX Phase III expected with year-end. is have we're hyperoxaluria patients second to PKU half SYNBXXXX of data of momentum program. healthy volunteer also

for and Greg to into a who a an critical during to I'd through upcoming September programs our brings thank the as we commercialization, $XXX.X welcome Today, Michael XXXX random us healthcare a also operational and balance categories the Synlogic asset across like to We carry We've financial interim past development Michael million and an impressive financing. Biopharma Jensen. served Given CFO, new through as our Beloff, strong and has results XXXX, like milestones. therapeutic through CFO with companies background we late-stage company. team from stage out strengthen registration. positive cash progress of in sequence sufficient our had complete to sheet XXXX. well able our equivalents this in and were and successful into I'd

could endpoint be of diagnosed option. with with A population. as due adjunctive treated on treatment progress. oral metabolic precedents world In in clearance as of monotherapy From for de study Synlogic diseases. in last needs. showed engine medicine. just convenience patients the September data two or to carbonization. PKU review Synthetic an as -risks around to for today and accessible Phase related at similar options the across safe, of treatment. In as validated paradigm a biology limitations systemic have was [Indiscernible] a premise and and based are our recent towards and rapid as the rare and vision acceptable GI These considerations. reversibility efficacy. a a six PKU delivery, biotherapeutics in and Jim both by drugs, I'd profiles to for safety of ' PKU well common created Biotics PKU presenting immune under-treated like ourselves at Lu a in and potentially Tim grand communities X approval, the Phe and candidates reduction II diseases. mechanisms and Let's With share absorption lead approved our on design the both breakthrough People Phase competitive or of could for on safety untreated And Collins of its years, remain patient to and used that due with US based MIT, by producing into proof-of-concept to an majority transformative for full of product behind we titration, The inception as of small birth Phase Each we our program applications founded lack drug path commercialization. PKU potential of application efficacious, and a X FDA has profile the meet advance new in that's specialist’s Lab one registration science year, current the community, that our

so makes I'd meaningful to We now to upon to approach potentially hand studies. eager PKU. advance call Molly pivotal our towards forward program to commercial expand are over continue to the in this like what

Molly Harper

is understandable with the rare large surprising, it a today's XX,XXX Despite given Thank untreated. a that disease It's limitations are the PKU Responders of of but Kuvan options. standard rate approximately to U.S. making two remain population. severe PKU, Aiofe. majority the of X. majority mild response population. large treatments, to forms In more a tried or you, Sapropterin the care This is PKU have is alone, patients PKU. XX% leaves tend approved patients approximately there by treatment age is patients at XX% all This of untreated. of

was Phe viable need to was respond of designed absorption do it per associated to that an and time what GI XX% In for Kuvan, we it's drug these XXXX, Kuvan for Kuvan adjunctive or XX% vast given a times. patients option, majority Palynziq twice generic due before tract has at executive the and concerns. at presenting for without of $XXX interim occurring colonization with went new the business whether is fits the million - reflects box require Phe Palynziq levels is consume risk approach an PKU limitations well restrictive candidate which of analysis often SYNBXXXX the carry limited that, above Phase with patient in treatment Kuvan deficits option. not to REMS XXXX. and For AEs. or of penetration less large functioning auto comers and in epinephrine monotherapy untreated nonresponders In usually the September analysis, life-threatening achieved approaches, opportunity as also warning its systemic PKU. therapy their Phe those with whom pivotal who treatment. needs. all and Synlogic's neurocognitive or Synlogic Note PKU injectable. an mean targets, Challenging, short, the a all to in remained of uptake. take achieved The and the adjunctive people self-administered injectable population in a reactions reduction The The any risk two announced study. safety other approved patients had targeted XX% these anaphylactic of program globally,

The three for a expected commercialization sachet being study the greater We XX% a target confirm as has studied In strong presentation that SYNBXXXX bridging why is of or product the rate times we provided volunteer patients potential head-to-head exceeded the also as shared day. met response. that and meals for efficacy. saw with offline parallel, powder for and eight healthy a four taken response

safe, tremendously I'd too III. to exciting a to We a oral and forward patient discuss advancing for been potential In to programs Aoife fast hand is call long excited are options. Phase back effective, monotherapy the waiting population potentially convenient, product a the new has and be treatment to like this to profile injunctive summary, PKU option. that for

Aoife Brennan

Molly. Thanks

of to after of Lets reflects year review the forward going reviewed X it how all commissioned X fall program advancing this study that an achieving interim two in the changes PKU data, we we analysis the Synlogic Phase with our we specific program, approach. SYNBXXXX Having and Phase with trial. many advantages our X study, Phase made to proof-of-concept of the information a study this we to of Last important ensure the needed the from to initiate had year. this to

second Firstly, SYNBXXXX based on of arm data volunteers healthy we from candidate. showing potency for added a product that the higher

the treatment We blood B to criteria the enabling second Phase infusion evaluation to to of are half who levels adjunctive first sharing east of patients amended have we to this looking with but to first in Secondly, potential. enroll continue the out on are set arm complete SYNBXXXX, allow data and of forward and the uncontrolled to that participate, year. sapropterin, II arm,

PKU are late we still selection hoping Number already forward. into determined of in questions activity answer. candidate that to to couple we one, meets So which development. that But will We've set? our strain of our criteria there from what are advance take data a phase to see

respond strain. volunteers, in healthy potential clarify compared did but on SYNBXXXX, continue the at patients As How SYNBXXXX higher effect profile, confirming in patients adjunctive or seen PKU who the patients levels for given greater our PKU have dose the Phase This the to choice III efficacy that blood will the Phe patients. therapeutic sapropterin, could Two, activity we've likely had Currently, of these use. included are activity will whether in for be in to a help understand candidates. ultimately is product us addition of to help trial. high size our

we interim the reminder, results the thrilled seen with in were a analysis. As

greater the seeing Just very same positive. the with course, are be

or End-of-Phase in that inform rate from a particularly have considerations. Data Pending the conduct note SynPheny to response have PKU important patients C the complete with mean two that both to questions, reduction on reduction will plans, we and SYNBXXXX proportion as earlier an answers specifics needed to will shared been help these meeting the to an this meaningful to other Phase study arm who final Try patients the bridging X. expectations. the we'll levels timing of X. at and needed in these We to confirm including have advance group. blood It's step focused represents in FDA, Phase us experience of which allow arm initiating of studies to

We be new get data products expect patients. same our timelines product either not licensed but to this to With candidates. developments to all path is is great a critical. regulatory necessary, science sufficient and to A for also the

of we fee use intuiting study established the reduction addition of In for collaborative with an approved and favor drugs, approval. of in full have our registrational endpoint attributes other the single two there support to FDA regulators, number relationship precedent PKU, are as in a a

for fits our 's chassis The products. [Indiscernible], biotherapeutic FDA framework drug is familiar with platform has our the within for FDA candidate. a live Secondly,

over both over biomarkers. had been across finally, And in based strain extensively of Currently, trials other patients new XXX mechanism a modalities. preclinical discuss and manufacturing is So a volunteers lyophilization, the therapeautic PKU clinical of healthy our as to significant those resulted the pipeline in PKU in it Given Phe. who with approaches I'll it safety in turn fermentation well-established confirmed need ahead now that strains of being analysis the a SynPheny to addition, and biomarkers from manufacturing de - dose we -risked is meaningful on both Dave. promising and interim blood Dave programs unlike in reduction and years bio perspective, advance of specific have the other of humans. it product studied In in path our In summary, use most. action multiple programs. exciting and

Dave Hava

HCU. teens metabolic about SYNBXXXX. for for thromboembolism our entering now and HCU result as the like second talk SYNBXXXX new or twenties. could clinic as and for be Aoife. strokes metabolism in in need program another and a deficiency I'd cause strong rare blood for the treatment a homocysteine This is approach can candidate this in have our a result, individuals fit. which have of 's Thanks, homocystinuria, in options, levels. Synlogic their disease-targeted drug can year intellectual amino homocysteine, acid, a patients There homocystinuria to elevated disability also is

a SYNBXXXX with is homocysteine. approach Our to precursor consume methionine, to

promising non-human mouse and from have data that levels. blood -clinical models we We homocysteine able to are primates pre showing lower

clinic the as a with another enter diseases healthy volunteers by assets of That us to inborn build pipeline expect will of a SYNBXXXX year this this program. results We we as in with metabolism. is the year. for important highly milestone errors of company be caused by end PKU synergistic the in

leveraging with as are clinicians PKU patients. the same HCU the treated In platform, same people to sites addition our at by

Aoife Brennan

HCU that have PKU learnings established the apply net through we We patients. upon for build through from the relationships that -- program work that and

GI patients much kidneys is intervention next causes hyperoxaluria. diet. stone which That an too underlying disease developed oxalate is portfolio, the kidneys, and candidate pass There absorb metabolic of between Over GI rare a called no the SYNBXXXX to to in SYNBXXXX year The treatment disorder manifests a metabolite with major formation. and mortality. hyperoxaluria the by beyond for Enteric and and in produces from being their the harmless levels lumen. chronic formation, oxalate drug and implications is this this formate crystal morbidity kidney pain causing program crystallizes oxalate FDA progressive with oxalate oxalate damage consumes and for that approved irreversible is disease. enteric tract may milestone to require the for There relationship caused as stone damage Moving an and our established leading stones buildup linear severe time, the stone. crystals

consumed the of be Our extending specific to in addressing same the modalities the potential efficacy to tract, duration approach oxalate target. throughout other GI enables compared activity

Dave Hava

and can that urinary oxalate fed volunteers high model we mechanism, fecal last enteric as and to diet We reduce levels dose manner presented healthy proof year we in that promising a we're showing oxalate of data view that dependent hyperoxaluria. a

to Given levels this stone and meaningful the established translate between relationship into expect clinically oxalate we formation, benefit.

the Roux-en-Y patients. Bypass We lower patients evaluate with can whether are oxalate surgery, oxalate of elevated absorption with study to those forward the Gastric now of moving SYNBXXXX in portion urinary in

We and metabolic focused metabolites. as Turning areas, pipeline. also expand to updates the progress consuming now have in-house diseases allows such including -risked GI on forward about us our these focus to other and de PKU look both especially diseases HOX early-stage to to our based sharing to they programs The of larger like IBD. platform, This when as gout, programs advance development. through our

reflects have collaborators The collaboration clinical Ginkgo our We candidate. engine. the two resulted in SYNBXXXX which Bioworks the of product strength

I milestone Michael to We've turn disease. established collaboration. already Roche results. financial also the year last achieved within this products with pre collaboration We review develop a inflammatory our bowel research -specified first to over will for things now to

Michael Jensen

quarter year of I'm those ending the for pleased XXXX, to period revenue for the of good and the full with a was the the Synthetic everyone. was IBD. of of bowel recently fourth for in And quarter XXXX or Revenue million due Dave. same no XXXX. disease XX, results novel collaboration financial the Roche is Biotic with Revenue inflammatory treatment for to initiated Thanks, there now. December you highlights for $X.X released discovery morning, review this our results morning, fourth Earlier we XXXX.

net period of share share fourth XXXX, the quarter the loss a million $X.XX to or consolidated net or for the $XX.X $X.XX or of in reported company consolidated million compared XXXX. per loss corresponding For $XX.X per

the sheet, as to marketable over wrap will December to of up. cash programs Aoife the XXXX now you balance you expected equivalents, XXXX and some through in recurring XX, across look I things our to Under will a ended cash portfolio. attention, we for our million us important to advance securities turn a operating enable plan, clinical million calls. back and of Synlogic the compared the to Synlogic readouts on updated Thank we take the future data to call metabolic your forward keeping $XXX.X XXXX. with Turning cash, quarter fourth $XXX.X and into

Aoife Brennan

all Thanks, pleased the across programs. we've made extremely Michael. I'm progress our with

to to Our goal the great will for several forward us to urgency team patients. busy looking treatments across our XXXX study expect to therapies the that meaningful candidate readout year be pushing the half We're new advance important the expanding in of milestones Phase second our is forward with portfolio. the with of bringing inform III our with a of which in SynPheny initiate year, in the will study PKU for help first final half of selection this year. we the

in human this we're for program. of to expect And patient our program HCU for well. second first a anticipating the data also proof-of-concept enteric We data half as the year hyperoxaluria have

well fruition sheet strong balance to break In work. we're with these to milestones addition, funded fortunate support be our to the to all

will We open for call the now questions.

Operator

question [Operator Instructions] Leerink. SVB with first comes Our from Schwartz Joseph

Unidentified Analyst

program. PKU responder I'm taking of a than among a Hi, is you're Thank mean you sense have makes Zylene you at But Juri drugs, focused degree other our overall because questions. a that the for to more patients. mechanism In remark, unlike response analysis your your the that for look analysis likely mentioned subset reduction a responder approved of greater for on opening Joe. to

program it uniformly. work seems should more like PKU Your

-- are mean overall So your wanted more reduction. a responder on than you thoughts just get to focused why have analysis the on

Aoife Brennan

response remarks product that for the to patient. it what and by really product question forward is which to the or Thanks, physicians cash agree they because and information Juri. hand and use your product giving the determine a to about what over prescribe the and looking defined not some profile, whether a to really to Molly I'll then make commercialization think is I on label

endpoints we the to at to familiar ingrained we language forward in that's think III from Phase the outline and percent in to a to patient have. percent and to much think start hand really important similar and responders important to this perspective it's on really benchmarking and the is as language I talk reduction that the it's look category, responders products. it to that Of the and that's following commercial I'll these trials. those course, we commercialization, case, within speak we our class population, launch, over successful Molly and And continue why perspective that report and of think all results But we'll and this this why hopefully, as very Molly. define I it's to a the days speak to use from prescriber the

Molly Harper

Aoife. couldn't do thanks precedent we to interesting for point, category, it's from drugs, setup And which as of in in then terms in in different do But great also Thanks, similarity while terms really It's promotion, further to what's the be a interesting or setting, labels. the it their the mechanisms and that how apart. it's approved have for drugs two of but looking labeling. And question, pivotal existing a because they seen have questions. done a to two were real approved but studies outlined, advantage Aoife completely and this quite is your registrational

analyses. the have are drugs outlined USPIs of of terms responder in their both studied approved in So and been

it consideration given So I of does had a the through precedent a need regulatory it's work? lot and and So a really that and to in importance and a following gone standpoint, this that that's category about to each promotional the from given it independent drug a a how obviously individual of when precedent patient, just well of understand which needs just deliberation. of the patient, standpoint was unmet set. given works really for speaks think mechanism it's And

Unidentified Analyst

then And responder noticed you. for we the your threshold deck. analysis your Thank in Great. corporate the change in Okay.

further is from reads could your thoughts you us. now previously. it XX%, We'll and for think XX% at paint into little context I just which love [Indiscernible] least the you change put referenced and just down on it get to a

Molly Harper

Yes.

in based that -- the consistent products we we that in number There always that call a XX% and the little how percentage and I memory, maybe and responder bit remember someone don't in I -- reduction. had here of based has blood clinically had for we all these -specified respond correct variability Phe on can my different is defined determined. defined responder me. We is else lowering had across So ever been in PKU terms meaningful is patients to kind my wrong X% on discussions pre the to of XX% with throughout. with with But of prescribers, or

So but confusion any what we XX% of clinically we as been that cause meaningful. kind taught is us always apologies if there,

Unidentified Analyst

just one more, great. could if you've XXXX. time SYNBXXXX and over than if was seen agents just based wondering each since could other. then trajectory of active be on And the on just Okay, what I more to so squeeze I relative elaborate to appears far the you

you did Thank to more very you accelerate overtime? or reduction example, did For XXXX than consistently be see active you see XXXX the much.

Aoife Brennan

Yes.

washed Xx So dose XXXX XXXX And how was of we of XXXX. is superiority every Xx. similar XXXX ratio activity patients from ratio consistent greater was in one activity evaluated the the you're went healthy further where to study XXXX crossover and received and XXXX the greater and the when determined and the it head-to-head single defined, biomarker step with a of vitro same a that a we compared volunteers and a perspective each in volunteer dose XXXX patient in dose vivo, we healthy mean an of at of same resulted then out We patient versus back then compared level, at in in mean, the there received preclinically, a in production. that individual

And seen first-half. consistent would and certainly on PAL from and once expect in PKU based we've time. the perspective over data we we to and more be it's or in evaluate absolutely believe made So that biological activity that in back Xx patients the to that healthy we've a that it's a think see finding been across leads make we consistent based the greater it production. biomarker enzyme on data make preclinical of every We've the it piece to to that collected, later clinical and change it volunteers, consistent to sense? Does active underlying that we've changes no

Unidentified Analyst

you Thank much. Yes. very

Operator

next comes HC Wainwright. Mitchell Kapoor from question Our with

Mitchell Kapoor

questions everyone. the Thank you today. Hi, for taking

just the blood how with respect ask levels, XXXX you in what first to potentially constitute wanted better reduction a The to meaningful one, Phe XXXX versus think and much could would look difference.

Aoife Brennan

I believe we would tract got Xx, of looked say happy on standard stage XX% based the this the a GI in all, we care we in of XXXX showed eight and seen the think is the mechanism significant PKU, mean that all first it's the were a strain I when in first patients blood levels. of with Phe at resulting analysis, around comers -- is in with really reduction first we is we which that working, a seeing reduction, consuming, that

only the biomarker be we going and know around there was based XXXX to had time volunteers XXXX activity Now than same on activity, this is so that data. better we data Xx healthy the showing that

X. So forward moving into more we very having and we're candidates into really a that candidates a which a potentially not Phase to move decision in taking stage two think we're on whether of it's of those than in terms about forward binary Phase this X, we're are decision at viable or good position

we healthy be until going So make going but data strain I is volunteers, and think the similar forward, activity that see the decision. saw at we're we in see the more the be that to expecting would we that to expectation to hard to for when biomarker it's data, look what XXXX

Mitchell Kapoor

you development strength. formal necessary if newer not, you received feedback the Okay. confirmation? to the be formal would any that get And FDA then, no have And work from would with when additional that expect

Aoife Brennan

producing have same we has the instance, it been product, forward had to collaboratively we profile. that have And only clinic, not very with throughout XXXX the used same on both used able into fact a it's five but products. on the very, it's yet, we there's safety with the same the development moved any XX.X% based of We work, toxicology End-of-Phase very based and meeting XXXX II that the for pre were pair really really when base differences, fact identical, doing FDA our rapidly working chassis, the without move similar -clinical enzyme, very

all we that, volunteer to End-of-Phase are define study data on healthy looks quickly. like, that very, our based will some meeting, So III able our toxicology have data it's and that very have based robust have conversations arm until second human good what and the you XXX% position but meeting as we've II But obviously, we've study a End-of-Phase completed not work that a the our SynPheny. guaranteed, forward II of to-date. we very Once a move completed expectation we generated in Phase head-to-head know, we're but very once set into we feel is on

Mitchell Kapoor

it. Appreciate you much. very Thank

Operator

that question Nakae time, like Instructions] a Chardan. ask next is comes from [Operator question a Keay this Our reminder with As to you'd at if

Keay Nakae

Yes. Thank you.

you enrolling any For in EH, patients study? challenges experiencing are that in

Aoife Brennan

So thanks Keay question. your for the --

studies, for we a So this studies I have that to at trials. is sites stage, guidance, at which think, our It's enrolling, chemical that seeing meet on this adapt. feel the to at our and challenging for good for good are But progress. year. activity our the peace guidance a been And track position we we're are proof-of-concept with in meet we and all to establish time strain to

year things. research I be think to and in tough other we've with a clinical been So external to been to of the able you through credit that it's push COVID team can imagine some as challenges It's the a

Keay Nakae

all Okay. have. That's I

Aoife Brennan

Okay. Thanks, Keay.

Operator

call I'm to for back showing closing no further turn questions in Eva queue to at I'd this like remarks. time. the

Aoife Brennan

call remiss and wishing participating. concludes morning you Well, a for call. all. the this joining This Thank Great. day. much Bye-bye. conference so St. on if Patrick's thanks everyone would without happy Thank I today's everyone us for you ended be it

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Synlogic (SYBX) 17 Mar 222021 Q4 Earnings call transcript