FBRX - Earnings call transcript Q1 2021

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Operator

Welcome to Forte Biosciences First Quarter 2021 Conference Call. My name is David and I will be the operator for this call.

On the call are Paul Wagner, Chairman and Chief Executive Officer of Forte Biosciences; Dan Birch, Forte's Chief Medical Officer, and Tony Riley, Forte's Chief Financial Officer.

Before I turn the call over to Paul and Tony to discuss the business and financial highlights of the first quarter, I'd like to make a comment regarding forward looking statements. Many of the statements made during the call today are forward-looking statements, including statements with respect to the company's cash position, the potential development timeline of the company's product candidate. materially contemplated differ statements. our could results from by those forward-looking Actual results as considered not indication Reported be performance. an should of future at the with the cause our a results look our materially. of could factors SEC differ to discussion that Please for filings

are XXXX, forth The we set forward discuss form ended March form the looking in ended to based XX, Forte's quarterly XXXX Forte's update as statements filed XXXX. on of obligation will highlights SEC, XX-K and any as year financial law. filed available on these as and annual also XX-Q is over report first this XX, SEC the on now us, for by for the who information the statements quarter on this December of except in call required Tony XXXX. to will to the Additional the report forward-looking information disclaim quarter I XX, on with turn today with March

Tony Riley

months at clinical product fund as to next Thank XXXX now $X.X for of our give We of equivalents believe was first quarter in and Cash is update you. $XX.X in I results of sufficient cash quarter we million. XXXX. the first advance least utilization candidate the we the million to operations trials. for continue through ended XX cash will lead with our FB-XXX the approximately of first which financial XXXX quarter an

XXXX phase due based as at manufacturing million the quarters trials. XXXX, costs advanced first compensation In development increases respectively. and clinical terms research for stock were FB-XXX million we non-cash to of and of X.X expense primarily operating through expense clinical development in $X.X two results, and and and XXXX were The

in were XXXX, The XX we months expect XXXX We and increases ‘XX expenses and were million primarily quarters next administrative the expenses development professional auditing of during as operations, respectively. headcount due ended legal, on research for increase increases compensation for non-cash continue $X.XX FB-XXX. services, quarters and XXXX million the as including March share first $X.X and June public XX scale and and XX, between per expenses fees to clinical became and XXXX $X.XX development the a the and company stock to $X.X and General based business our in Losses XXXX. were respectively. consulting we

shares of the million XX.X end stock had at quarter. Forte of outstanding common the

XXXX as with details form Additional our the can financial our today on first of found filed results SEC. XX-Q in for quarter be the

in Paul. www.fortebiorx.com. investor You hand I over at now find the can relations information website more will to also

Paul Wagner

Great ask wanted thank you, questions Tony. We're short an I fairly going call any opportunity investors give to have. may to you keep that today's to but

those Q&A FB-XXX Forte familiar Before this live meaning for developing you that the not treatment disease Health States inflammatory pediatrics. the that Institute XX working been people more the and Infectious a Atopic dermatitis of than those Institute of with on biotherapeutic we get we're of to alone, We've diseases. Allergy skin of are collaboration affects living with and of as in diseases is atopic National on dermatitis. in there on being consists with National therapy first half focus of call the United the the and a bacteria, is the FB-XXX approximately million

that safe unmet need. options that need there is XX% particular could for for for FB-XXX a are no In patients significant of to as be treatment dermatitis as We can There's in limited. treat these at thought the and cure have the that therapies hopeful fact, of effective our pediatrics. number very population and one atopic suggested being leaders present high and to believe pediatrics we're meet XX%

XX%. disease. talked unmet in year highlighted FB-XXX need published completed We to phase that science designation the was dermatitis was granted in of disease as of that study data them The XXX% of at to on activity to for or XX% last based as after the index. moderate and Track previously, EASI the in three Fast patients, Xa two between EASI-XX In seriousness and EASI-XX, and EASI-XX October, but referred FDA a we've was measured least eczema and subgroup that nearly know severe third and activity improvement as disease achieved severity As the FB-XXX nearly recap, was I and and XA all this and improvement atopic stopping and by about was demonstrated had EASI-XX. for translational before, XX% weeks the XX baseline quick of in XX% therapy. medicine, That trial achieved achieved XX months from EASI-XX that a XX% a just that we've pediatrics EASI-XX a a effect proportion durable trial, eight treated patients XX% the

under demand, with in randomized targeted moderate two As due older years strong enrolled adolescents subjects atopic enrollment We we and with announced of disease to the trial dermatitis. enrolling adults we severity. XXX enrolled of mild XX those subjects the moderate age to are majority completed able are pediatrics, majority but were and quarter The last enroll and to age controlled XXX also subjects, study. originally of

in expect of third We the quarter. the announce trial to results this

at as our well. of us million utilization end of XXXX, Tony the position, terms cash quarter and the positions of rate In $XX.X we our had cash first mentioned,

to next have sufficient expect We XX at for months. cash the least

filings our XX Lastly total more our we conference greater patents that and I which to since U.S. issue countries. really announce and had XX am brings have in call, the portfolio ex-U.S. two up patent than to last pleased similar progressing we

now up that, for call open will with the Q&A. David So

Operator

session. will Bansal time, Our Mohit a [Operator Instructions] is be question we from Thank this first question Citigroup. you. and conducting At with answer

Mohit Bansal

And progress. Great, thanks congrats my couple for question. taking questions. of A the on

in regarding , of is use versus as two [indiscernible]. the by phase So used as EASI-XX which endpoint one trial as IGA is an your [indiscernible] well

one better probably for endpoint a is the of are after? you any population thoughts kind So patient there going which

Paul Wagner

you question. do that I Dan, that address a maybe and much few very well. want it. as up Appreciate can follow comments Thanks with to Mohit. Hi, for

Dan Birch

And three what you plan as powered smaller usually is studies. you're Clearly, not our in for sure. do when would used trials, three that's Sure, But endpoint. that phase phase well. two the phase we IGA for

and EASI-XX when alternative very use clinical is usually a this. uses for the endpoints like common So phase two trial

Paul Wagner

so then as a And EASI-XX there's Dan. looking a end in obviously I just of IGA of one and EASI-XX before, in endpoints at Obviously, as add EASI-XX. different endpoints. we're is Thanks will is EASI of improvement we've the secondary talked well those one about variety EASI, number

Mohit Bansal

is FDA the you’re seeking of we permission immune particular is live is helpful. the getting, regulates guidance bacteria, that vision have of super takes therapy? from division it, given or Got which And this care bacteria so it one then does one who is the yours question and it live it that been it matter is

Paul Wagner

question, Mohit. interesting really a That's

division being products. So the of and by it vaccines overseen is related

of was I think were of might vaccines the one cholera those. actually that bacteria, go just back history that vaccine to living fact the certain

And think they've been given mandate I living of so the bacteria. all to review the

reach call do consists division products, the a therapeutic that but of they have biotherapeutics the bacteria, of the to for out the interest. a indication living into microbiome So

the those close after case, collaboration division, two. there's Derm between our in I So think a

division the be responsive. the opposed know. differences whether Derm But vaccine I this been working of don't has product any terms there division of with division In very to related as

push division that vaccine thought not, instead, of interesting designation we the surprised is I middle I in wave application get that thought our in And on that. COVID. I really track we focused And something of bit very the granted and I that second a that would maybe have was was vaccines were would about fast products but be the did out fast the related track of designation. COVID a

So think and division you you FB-XXX. the the wanted any comments shows for to that's just I have support other the Dan, of did responsiveness add?

Dan Birch

would great. is fact said emphasize on from a review involved I the you division And they Derm the just And I Derm what consultant mentioned. think our bring I as highly do the is Paul division. that do think No,

Mohit Bansal

helpful. very Super Thank much. you

Paul Wagner

Excellent.

Operator

is from next Our Brookline with Capital Kumar Raja Markets. question

Kumar Raja

questions. my taking for Thanks

your are plans extension? extension to the patients trial, to for regard open with label are treatment placebo a what the on over is trial that what thoughts in So once complete? open And your label rolling

Paul Wagner

a Dan, did for you Thanks that? question Kumar. call. want to great address joining Yes. the That's

Dan Birch

Sure.

a initiated extension for have open we label phase So these two subjects.

So the long. year patients. into including we'll study extension focus will placebo this a on safety subjects open enroll allow the to This will be and

Kumar Raja

Okay. And as that? are in as ex-U.S. well you terms thinking of how guys plans, about Europe,

Paul Wagner

Asia. plan turn some how And on the that? maybe here. be is I'll thinking some scientific integrated want in like global make then he's development we're did working to able and aspects, discussions through Europe potential pursuit if We're and over that what things comments other that have Dan Yes. There European include insights now. that, you having well got to to to good an as as do development to right any comments But, we'd about is make Dan, it any would That's those I we're have Certainly, you do unique are of think to question. now. about those advice to other Europe. a

Dan Birch

Sure.

we FDA. proceed we two are into the focusing elaborate continue phase from three And to obviously, interactions the with program. on as do Just our so to stage we'll

issues are that for for have Europe. work the little the would a to EMEA scientific with There on have avenues sure alluded we We to we -- U.S. approaching begun there the advice. that with lot can a we like make of our already way involves Paul both we And process those. think Europe. through are As some looking consultants obviously and program potential

Kumar Raja

XX? are Can thoughts more And as mentioned data finally, And lower Or patients? does that more the patients trial to XX. from those to you in great. the closer Okay, impact is to well, it compliance efficacy Is as your the they the limit? majority it color? give that how you the on guys closer of much under

Paul Wagner

then Kumar. question could as Dan make I'll well. and provide Thank comments a insights can his good you. Yes, few

under the So we XX. the are said, breakdown, as majority

under very So the XX% XX, subjects about are adult of roughly. XX% are

much terms issue. don't In of see compliance, really the that an I of

patients, times very year would this applied the day. a a be multiple to to is just or creams is And that steroids two applying therapy. therapy isn't to typically other oftentimes therapy a as spray. has applied day again, there It's a times therapeutics, young be ointment reminder, the have three and multiple day. that's a again whether that olds, a other And it's For parent or be caregiver, multiple a a to a therapies times are development, applied that this

water a it's week. and only a So based spray three it's applied times

other any don't an XA being issue. heard that I an It issue. We Dan, is a an did you of trial. from think have in haven't that that's I perspective wasn't thoughts? compliance the So really think issue certainly

Dan Birch

the They're it's was say I product are a the the occurring bacteria, idea. parents strains selected naturally applied patients just the of again, Yes. really fact children going really highly to anticipated. that of nature of to this that's with kind it's love in our though,

our so to And that's allowed I us over trial. think what's enroll

there non a therapy. is about chemical lot of excitement drug So a

So that will compliance reflect their I to a lot in by parents forward. be to or And go children participate the on think patients our interest we there's think this of trial. as their allow been I

Kumar Raja

Thanks so much.

Speaker

Excellent. for questions. Thanks your

Operator

is next Thalmann. with question from Ladenburg Michael Our Higgins

Michael Higgins

different anything the guys far based in kids, for is ask additional are congrats that? the forthcoming to phase are, Appreciate specific groups, to in X, secondaries kids are progress. by the curious on Thanks, ongoing so great. around just any older I'm very phase the here the you the that the opportunity continued younger This X are looking age here. questions that

Paul Wagner

provide couple any will then so comments a is of Yes. want there's stratifications. Age other make one to Dan if and those a I insights, stratification. you

age, even were the difference And provide? trial, activity. terms younger the the we in in the so only adults a at significant pediatrics, is between weeks maybe I was that regionally, adults looking trial different. treated the Xa don't and related or the any in for on little certainly overall consistency they comments didn't we whether you even significant and treated and previous to Xa and was there other there The no question, see or the are that we six any but adolescence, the think of in were to adults based pediatrics saw want adolescence. Again, the Dan, bit

Dan Birch

at very no, of we I looking people think what we're previously. consistently No, observed because

Michael Higgins

guys. Thanks

some been development Second more suppose. others in their a is recently, of question There's I difficulties devices. with

Thanks. the remind conversations could you spray with terms device have just us are FDA of where with other Any to as If factors human been completed? studies the in you device? regarding that your

Paul Wagner

Good Absolutely. question. Yes.

first FDA actually in it's of a master that So all, spray product. device approved used file has and an being

market. already in the it's So

expect really there. So issues we don't many

would agnostic applied a to dropper, to form is be ways application, again it In there it different terms of the say we of could this be a method a could device are be sprayer, the considered many could whether can the skin. be swipe, it it's bacteria a

asked So you with said, about studies. human that factor

something into moving we've it factor obviously, it focused and the But ongoing Again pump Now the that's study, the had as that on, studies. now it's we're actually putting that study forward live bacteria, adding just the human [indiscernible] to pretty instantaneously. as the therapy reconstitutes currently, is just we're the water straightforward. in prior Xa well almost sprayer

then on, it's that immediately it and it's diluent the So instantaneously, as it's primed after soon reconstituted. put [indiscernible] spray then almost resizes pumped just hits and pumps the and as

straightforward issues patients with pretty the or able apply no therapy. So being far the use and to

Michael Higgins

great. when on us your milestone [DAHS] begin? those to Can that's you may payments remind Okay,

Paul Wagner

guidance we've but I don't Yes. think given late. that, they're on specific

So after points be they program. major would value in the inflection

Michael Higgins

appreciate feedback, Thanks. Okay, the guys.

Paul Wagner

Sure.

Operator

next Securities. [indiscernible] is Our from question

Unidentified Analyst

Good and taking Tony. my Thanks so Dan afternoon much questions. Paul, for

sense in safety the and X phase these groups on the data on third be pivotal satisfied database? up will you age adult? going the a will then you're and Or achieve quarter, label? to is pediatric of broad people, populations across approval the patients the cadence the of trials positive in can studies give coming after for focused broad be the that given many need would for how And/or if the So first us parallel run

Paul Wagner

like. on what of on that we've comment to but and FDA In looking database, of therapies then type what safety satisfy highlighted, need think if they mode label. may way study the dissimilar patients is after on with end the of extension can broad Dan placebo that it's the at words, too always of high study. go and I that you not what might particularly as X looks for the for patients, level of FDA this. be indication And encourage all on study part safety more sufficient adults they can to be was our seen this seen in might trial certainly and to discussions phase questions have just as extension an stay pediatrics also do a this study phase we terms that approved we through from the is a other an the to one we've have. with study But responding to not of Dan, that have active have good X can wanted there? hopefully, there that to have able who guarantee some Dan But that to that add

Dan Birch

as with children And we acceptable. and No, we would very been discuss the have we with as same. adults, I and when phase will previously [indiscernible] adolescents, again, that the X satisfied approved program Paul be requirements expect the them think our with do we're and And of for finished our that that X. aim we I phase to, all agency alluded single to with would would our interaction

Paul Wagner

our be So separate would but one need wouldn't all for expectation study. we to be or adults studies again, that would that have just pediatrics

Speaker

for or Asia they just closely more forward different accept quick bit is or you endpoints conduct could separate Okay. look the filing? their would scores and on what a What to? path geographies are you potential [indiscernible] or to endpoints? one And follow just elaborate those geographies that those European studies a regulatory little up, more need Would use readily

Paul Wagner

you can add that I to few a comments? and maybe did address Dan, want

Dan Birch

recently IGA using know got [indiscernible] their you again the and EMEA did studies Chris, the the with approved they United Again States. in Sure.

that they But acceptable clearly So have focuses they IGA does. have been, different than there they've U.S. the demonstrated to is absolutely them. the

for would the again with be get having and clarify some what required advice interactions then be So some we'll consultants to potentially EMEA. scientific

Unidentified Analyst

Great, so thank much. you

Paul Wagner

[Nicole]. Thanks

Operator

Our B. next with Riley. Instructions] Patel from is Kalpit [Operator question

Kalpit Patel

for thanks my Hi, taking question. Yes.

meaningful would range, ongoing useful? clinically one trial addition your Delta be a quick [indiscernible]? a that'd If the study. there's the view, a Is for looking Just specific that in in be super on to you're there hitting that in Thanks.

Paul Wagner

Kalpit. Thanks call joining for the Great Yes. question.

So putting pediatrics, want the kids is that therapies they safety other kids. in uptake particularly that's is near activity as this after And some has be I as effects. robust serious it term that clean. safety, quite clinically a the is in for be on them. placebo is either going the psoriasis, safety therapy comfortable measure, that comes between we've XX broadly. well. that somewhere leaders think in question used that's Delta endpoint the the would point difference And to safety if based answer a in but of that indication, profile and precedent easy And terms help. And great that's point asked in would issues going can to any be XX natural, I example placebo There's of not be if very and clean, they the has that really that It's as market. talked top there's, number And that difference the a the What also to profile, the the where psoriasis, to active and to In have profile their and back biologics, to relative isn't with need very between is very large. or are doesn't about safety easy market. the therapy in other clean significant the XX known XX parents think some under long the focused a something an words, for they've had one,

by is bar the activity. the I the bar So on really followed think safety highest

think moving then don't getting pediatric of market. aggressive that would the respond Some the uptake paramount I therapies. the on to to particularly But them parents think profile therapy, the start fraction I really to more patients is safety this in in

Kalpit Patel

a drug? just understand, up species Or thoughts under I'm does just related bacterial curious for IP IP a to I follow to the FB-XXX. I'm I it on surrounding of the like the mean related you the more had thanks. your IP hear quick to protect is that. IP species? also can trying Okay, actually on include bacterial formulation this?

Paul Wagner

Kalpit. Sure

mentioned, to had So as issued, up XX. new just we patents I two we're

of starting range skin. the intellectual really the culturing negative Now, Gram a around off and broad property patent of bacteria being of is it's foundational

And not a with was to came get were trivial. from NIH and the is that up So that. technique issued it we originally And there, that able for composition. the patent

is So formulating It with for taking of it's product different bacteria kit. into a the It's formulated that that skin and the combining potential therapeutics. that other drug including product. used, off atopic into of using dermatitis, a treatment diseases,

this pursue human that. negative separate mucosae on study was and then it's which the this have the be or issuances. path sure skin there fairly to broad. Because So reason. specifically, very property came work [indiscernible] with the bacteria, wasn't really But really accelerated start really broadly number way is able NIH off for negatives more of very very we much I down one aggressive went to [indiscernible] we're to And been the for We've that And wasn't going of been again, been clean. have a issued again, in there pleased Gram on patent before them. culturing because for on done patents intellectual up hadn't fact, technique prior that track with early Gram to

So more coming. again, we will patents have

and the that position in the very well. I be in expand as a have reflected solid think XX that'll nationally we're we and with

Kalpit Patel

Okay, Paul. thanks much very much. Thanks very

Paul Wagner

call. the for Thanks Sure.

Operator

the Wagner and like we answer back the and turn reached I closing end of Ladies to gentlemen call Paul question for to have would remark. session. the

Paul Wagner

Thanks.

forward the of excited. We're So the we're months a to trial readout, all quarter. as and are as few the you really third as looking well in

you you available if those of have and after we're call Thank take the thank So again. to dialing any in. And good again you any for have afternoon. a questions,

Operator

This concludes your today's Thank conference. participation. you for

disconnect this may at lines your You time.

Forte Biosciences (FBRX) 11 May 212021 Q1 Earnings call transcript