BBI - Earnings call transcript Q2 2022 | Fresh Tracks Therapeutics, Inc.

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Operator

Welcome everyone to the Brickell Biotech Second Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following some prepared remarks from the company, we will open up the call to Q&A. reminder, this conference call is being recorded. I would now like to turn the call over to Garth Russell from LifeSci Advisors, Garth?

Garth Russell

good and operator you, afternoon everyone. Thank

Dr. on Rob Brown; me Chief Chadha. Officer, Medical today's Office, Chief Officer, call Officer, Executive Financial Officer, Chief Marchio; Chief Brickell's Bert Luchi President Deepak Sklawer; and R&D are Andrew Joining Monica and Operating Chief

to call the risks begin, we results Company. this reflect these cause are to certain conference These uncertainties that like will that contain actual everyone that to call. as statements Please Before webcast remind forward-looking and forward-looking could opinions would our of this of I note and differ. statements about subject date the statements only

our will to future that or could We statements other call release It revisions these Rob publicly Form forward-looking outcomes or my the cause in actual the the statements Rob, on are forward-looking SEC. events. discussed Factors to most is filings on detail Executive results of Chief Company's to differ expressed yours. X-K to with floor undertake Brown. or those not or and the turn materially reports greater in XX-Q pleasure periodic from revise is in filed information implied any the results to recent our over such now of and light Officer, XX-K by Form publicly new

Robert Brown

company and shareholders. value advance next programs time Thanks, This innovative of a our pipeline lives Garth. class development to inhibitor therapies. exciting in our a by STING today. now as us generation BBI-XX generate for Good platform therapeutics and continue our transform an afternoon, strive inhibitors. autoimmune everyone, is as to and as first thanks highlighted developing call inhibitor, for patients' joining kinase our of This BBI-XX, These our by is we inflammatory for company novel cutting-edge potent DYRKXA we define our and

program BBI-XX. it initiated in marks is intended with study an the into humans. our company Advancement of a for inhibitor administrated clinic quarter, announced Phase our X milestone of the inhibitor second time of significant autoimmune in first both lead patient been During patients a the novel as diseases BBI-XX orally has DYRKXA dosing a the we first target, DYRKXA and this for

progress pleased are early thus report track study the and with line by remain in MAD far this We to and top XXXX. SAD results on

addition, lead STING candidate that In for year. our acquired are we earlier activities preclinical development BBI-XX, underway this inhibitor

SB as publicly past axillary submit are XXXX. earn as as of we available. Finally, single-digits payments from eligible of I'd to they to in XX% course quarter as regarding high forward stated for on milestone the of bromide recently program for relevant ranging FDA treatment like is we to tier This various to gel. sofpironium sales on well payments, We any updates become and additional which this sofpironium mid to or SB the May. to sharing third teen-digits regulatory it for hyperhidrosis, Botanix that Brickel sales plans briefly receive to look this out of net Gel Botanix to primary touch the NDA to bromide short, sold the

Monica to on it Monica? activities. pass provide to development I'll update Now pipeline ongoing over our an

Monica Luchi

continue the year. productive everyone. and of of half this very and afternoon, Thanks, second had delivering the first look we a in half good XXXX Rob, trend to We've on

with our tolerability, initiated for atopic AD evaluate and As blind, Phase is placebo safety, selective or the randomized, and of Rob clinical highly inhibitor. This the and to dermatitis orally just during healthy we controlled potent designed of BX volunteers pharmacokinetics bioavailable in short. BBI-XX pharmacodynamics X mentioned, trial capsules double trial DYRKXA both second quarter, subjects

followed XX by enroll over in placebo volunteers. the a placebo, to which assessment approximately up of assessment healthy administered ascending SAD daily multiple or or capsule BBI-XX ascending of part single is XX-days a consists planned. volunteers of once dose healthy for capsules expected as first study The of or progressing The study to MAD dose BBI-XX XX is

part of BBI-XX plan approximately atopic dual XX the for the X top scientifically of patients with develop inflammatory is which Difficulty] this and assessment to diseases. of include report and line month efficacy, adaptive the the expected a broad represent parts year. Phase track This robust mediated to treat of action for over and in preliminary package our believe the of potential program, Diffciulty] study next to the system of [Technical the broader model mode we This of [Technical of BBI-XX initial data BBI-XX moderate fits currently BBI-XXs been the with both auto with study, strategy the both MAD will as treatment such, second promising Difficulty] a the and this remain that's SAD DNA shift on we MAD we to study modulating preclinical As by that the observed [Technical for to compound debilitating dosing. on a diseases. these could disease. immune to paradigm of early in range of XX an results severe immune expect Based to-date, the treatment design compare the we in initiate validation way to from part part In and days next study placebo serve immune

coming covalent STING genetic non-alcoholic orally portfolio erythematosus, as systemic next to X in first interferonopathies. of investing a in and Carna STING steatohepatitis established of inhibitors which BBI-XX the lupus excited currently to are such generation dermatomyositis, Genes, number global are known inhibition of that space this stands other Several is respect to activities resulting forward to drug key Phase looking STING study novel a of or program, is are a underway has well STING responses. Difficulty] of believe established for pharmacokinetic and progress pharmaceutical reduction immune their linked staying next the signaling already are our Japan. BBI-XX, [Technical clinical differentiated this mediator companies to program rare in as NASH palmitoylation. series pharmacology available for high Excessive Preclinical we pro-inflammatory as in which exclusive mechanism and developing in the cytokines, Stimulator discovery of are significant inhibitor initial favorable we BBI-XX to we well of continue Biosciences, months. an the company proof potent Interferon ongoing over and toxicology unmet needs, development in With acquired of We shown these rights profile. strong a STING safety need through and through inhibitors from the and novel,

continue throughout rest enabling the year this activities to conduct support starting expect to of these IND to We studies thereafter.

touch the review DYRKXA, Bert generation on which kinases. over hand call inhibit and like I includes TTK, our of new XXXs to would library the LRRKX, kinase CLK financials, I chemical next that of Before inhibitors, to to entities briefly the

shown has outcomes oncology kinases models designed these conditions to range inhibiting the broad disease Importantly, autoimmune, promising and numerous spaces. neuroinflammatory, mimic a different rare in within of

to to conducting debilitating research potential financial novel brain overview. some pass a kinase for high and these Bert impacted now fields. over like to are as of optimize I'd options the treatment characterize and identify, inhibitors diseases provide the call Bert? goal within to We them of penetrant these with progressing non-brain penetrant

Albert Marchio

Thanks, Monica, everyone on to and the good day call.

to as contained statements second to encourage our cash be XXXX Before of financial results, million equivalents XX-Q, Form Investors with website in our the quarter which I filed XXXX. report MD&A summary and read want the I Section you Starting and consolidated provide a $XX.X once can full the reported accessed cash cash, XX, financial through on in of of company our SEC. with the June

asset equivalents year. support at for expenses in X% to expect our the ’XX quarter Revenue fourth by ECCLOCK Japan R&D second program the clinical Pharmaceutical. We Revenue our clinical This driven of of U.S. the operations and Gel of the the for for substantially quarter in of the quarter Phase the $X.X for higher second with primarily million of for $X.X the $X.X XX%, prior agreement primarily million Kaken this the provided under of with second ’XX, second of least consulting of the Fees which from -- our ’XX. of next This of cash X of last agreement that consisted $X.X Reimbursement near-term to recognize significant to year company sublicense compared versus under purchase the BBI-XX million quarter G&A expenditures. or which the million SB compensation $X.X trial million X was quarter in XX-months. will quarter combined year. contract Botanix related that were compared of of $X.X under to million. upfront development from million the sale second quarter an relate services clinical with from of the recognized $X.X fees. under the costs of Botanix, services was $X Botanix payment asset for was SB during million year revenue quarter were from and of sales clinical the concluded the approximately $X.X payments Revenue decrease the $X we the includes period second for the of consisted million expenses million, same for same administrative SB and ’XX, expenses purchase to income revenue agreement to ‘XX. transition start ’XX lower by of Phase legal of the million. for the Botanix royalty for purchase increase Gel asset and related other agreement second cash quarter primarily for compared $X.X prior expected the

to the last with Our quarter $X.X Rob the over net million period back year. was loss $XX.X call compared for turn I'll for for closing that, And to the million, Rob? second remarks. same

Robert Brown

Bert. Thanks financial recap, the for

towards broad of The exciting novel our of half defining of proved fields the in development inflammation. period of XXXX as and pipeline a in be focus potential candidates our with company's the we immunology to first shifted evolution an

remarks. we As opportunity we to start a building which to to SAD/MAD planned for XXXX quarters, the expect are and next in there early Phase for generation we from present to highlighted inhibitor shareholders. by is look operator and This prepared the line BBI-XX X open now including BBI-XX results therapeutic milestones today's ahead concludes important that ask believe announce call This candidates, our next few the and several study, top other questions. our value significant the novel continued development of up characterization the Operator? the platform. I'll kinase our

Operator

Instructions] now will [Operator session. first William Blair. Please ahead. the begin Tim question We comes from question-and-answer The of go Lugo

Unidentified Analyst

for on Tim. the Thanks [indiscernible] progress for question taking the in quarter. guys, the Hey, and on congrats

know, various the BBI-XX beyond you that, into derm? the in prioritizing it you've stage with next sort But inhibitors second the of it priority. DYRKXA and got you then across all, and So of And you wondering, the SAD/MAD the then to in atopic platforms study is sounds is kind deals X year? early priority and of over, both year, initiate data how turnaround I next obviously what about was early is for BBI-XX are like STING thinking kinase done the you've Part get patients that past resources after

Robert Brown

Great. for questions. Well, thanks the

can time in answer for remember the of Let you've man. And And one plans leads to terms is time a is DYRKXA been autoimmune DYRKXA first. study as drug's -- the timelines. SAD/MAD just got about then and is the forward. us answer diseases. go early studied inform at the broad talk you to -- in future in the our answer from been questions the got about to portion second -- me data first man the this going It's of to we This oral that you The real is, series the we're need first has a we’ll to this and pipeline. then

in X obviously, SAD/MAD So at as as we study we study, valuable. to making in so this do on like best it start we can the we'd work generate we data Part take time that we'll not the really to we're that start. we need understand really, but can, guidance soon the can when time next after the giving that of to

time pipeline, BBI-XX question then ask focus opine our about as organization say bit, I'll the our are a that resources the BBI-XX. and to maybe to a On of on our on vast little but and and the needless first Monica majority

first are the We transactions. through the library assets Monica, of on would acquired two add the color to those pipeline? being to like again, time majority But any of we our characterize is assets. starting to spent two the you

Monica Luchi

well. a add add can of I bit. Sure. Deepak then And course, some can as

Difficulty] bit a apologize was that not [Technical move into molecules feedback completely identify pipeline. So bit the various team the sorry, that? of the I his done want these [Technical to favorable have Quite Difficulty] there we've been in for a molecules but enough that characterization and which any work you [Technical Deepak the so various give this, already, there, on of forward. of has going actively sorting characteristics been that. we for I'm are Actually, awaiting through quite most Deepak, to has Difficulty] we’ll extra information do

Deepak Chadha

you the think, but our to is next of provided highlights, I just so right understanding [Technical gen add, physical terms now chemical Monica, in kinases. and focus Difficulty]

interested our of really that mentioned during things. because we We are neuroinflammatory update, very side much

whether focused brain So based the barrier are we on those properties. they our blood on penetrating really understanding compounds have next will gen kinases,

will interested the we'll doing chemical penetrating the And preclinical are brain up the some be barrier next in these the So side and of the whole that we we physical one. very starting characteristics be understand PK then planning properties. But focused And which look to studies step of neuroinflammatory vitro opens exploring things. to understand again, we and of into some be first we compounds. exposure are in will -- aspect, blood very will

lot -- our as a pipeline. next the kinases is of the for the gen XX months XX next there table on So to part on

Unidentified Analyst

Got color. it. for Thanks the

Operator

Selvaraju comes question from of Ram Wainwright. ahead. next Please go The H.C.

Unidentified Analyst

taking Thank Hi, everyone. [Mitchell] This on is questions. you for (ph) Ram. for the

broadly at look kind program? about and What thinking into The the a have give is you're can but bunch cytokines I speaking first other is atopic update dermatitis? go thinking to Could the this of on markers, you'll to you're different with that analyzing you what there. an the and tree BBI-XX pick you indication? as goes after program decision walk a and an you decision just on there through one of know forward us strategy

Robert Brown

Mitchell. that, in as jump And me Monica, well. start let Well, Sure. let me with thanks, to you then ask

variety what's proof remember of if it's dermatitis the this understand that We it's do dermatitis study, of with First, skin can in what going focusing body measure it's because and on think that it data a indication human to necessarily happening we're in the to that's a picked to then disease it's atopic for next. ideal decide drives, of little the we're if in a help that a important of mean going more will, and focus us as patient two and at to to atopic over we atopic we better the is we why that. maybe, to see will, long-term. drug can look really different can That but dermatitis endpoints have And we insight minute if part how working, you into I Monica, really we're to on if it think the how mechanism, vehicle, you doesn't you what I share turn that.

Monica Luchi

this safety. AD the would humans, the of you so about pharmacokinetics in wide to and extrapolatable disorders. a We're is autoimmune molecule assessing Sure, be as pharmacodynamics I've study and learned variety know, other time be and more to because in endpoints the the going that first

ex-vivo, various So we’ll in the at cell of be [Technical of going at inflammation Difficulty] to important cytokine looking be biopsies going at I'm [indiscernible] looking be we'll be about. measuring trends, markers talking we're to cellular we'll also looking markers, course, space via on us cellular populations that also to that's actual be

be at types about present us ourselves give tissues. So affects impact inform inhibition present how to looking what cells We'll which stripping, treatment after of RNA. also able chemotaxis actually pretreatment, we'll any are are will DYRKXA tape into about some of cells the idea this on identify what be types and

in, to applicability direction. shape us being So -- to information, other applicability. about information a in will in help the we'll we data so most trends It's stress going beneficial. AD to autoimmune have as enough which course, is it we on future on we're will stellar, the us probably or wide that the help? disease variety that think going that give that's as much data of data inflammatory shift disease see and the Does I way what be And of both that that the there's If can't one depending well. getting and

Unidentified Analyst

much. we very you as can absolutely. And you the you next clinic? the very Yes, Thank That updates thorough. towards was Thanks. move And just the then could talk are BBI-XX, about on there? expect what strategy

Robert Brown

would Deepak, you to Sure, about like talk that?

Deepak Chadha

sure. to Sure, Happy answer.

you So the is inhibitor BBI-XX out preclinical. or into know, compound as mentioned just discovery of getting, STING

understanding months more is vitro XX much the of very side next for into things. in focus Our in

have out protein metabolism going of us some the to study solubility, binding, interested we the carry induction, that's inhibition, gamut so plasma early already get starting an of read to in year. we planned SIP study, really is help So IND just the next vitro on are enabling data to

answer short going months once IND to as we XXXX, tox clearly, are move preclinical forward, subsequently on to first will the looking into There’s asset vitro of we then XX like human. XXXX, the XX work enabling be next we a work around So embark in And next then be into lot months. moveed and done sometime in six we the to in starting studies.

Unidentified Analyst

And you. last Thank question Great. me. for

needs that that submission more Just to want soft into be the Botanic for side to in submission ask -- done the to NDA about what on get coronaion?

Robert Brown

our them on Obviously, obviously, more I'll provide quarter. they'll the getting But submission. have done we're we think they're excited preparation tracking, But that for probably any guidance to done this that it we're that is that. it on any timing. stated that to Yes. ought in to leave of them more and I cusp is get with And on they we're Rob. them, in the This publicly of leave to helping provide team information working it

Unidentified Analyst

taking for the you Thank all Great. questions.

Operator

go Gershell The next from Please Leland Oppenheimer. question ahead. comes from

Ron Mather

on Ron Leland. Hi. speaking of quarter another and Mather behalf appreciate great question. is This Congrats you taking on my

Just DBI-XX questions a of portfolio. on the couple

that, in any recent of moreover, of the And stages thing portfolio there particular feel, of looking R&D disease be the of inhibitors at? have into kind made of and move would you in involved? think trials inhibitor progress how other be as are determining are kind you interest? follow-up indications on we you we will there funding what up would And clinic One a might competitive information And pick the disease therapeutics? to have some Thank kind look do and acquisition, any advantage to as any over also get just plans you. your of STING expenses what partnership

Robert Brown

Great. part. Well, the let me first answer

The first and question about is expenses, talk on we'll then first R&D BBI-XX briefly.

quarter the spend and what we that's going quarter or plus some minus work. like more see is do X of with of look far Phase forward look representative it'll what as this think of million $X.X will you pharma expenses representative our the like, second in R&D as I

So year obviously couple a bromide the earning quarters of we or than ago spending soft even different ago. expenses were very, very a

last quarter not probably is for So few this to the a quarters. bad next barometer use

make a broad too but it's product. diseases us at for about a needs, the still to portfolio, excited early time. interesting I find think much. early too unmet for this the the little indications it's this of stages what might for sense There's potential of to which us with opine On diseases on and We're really that probably really this BBI-XX number for too

other don't advantage provide on that you out might treatments of terms and the where if are any for there advantages, In know Monica, any STING’s versus have have that? an thought sense I

Monica Luchi

There's autoimmune auto clearly diseases related interferon of is and diseases. the very also pathway. overdrive to interferon STING the clear in inflammatory pathway that in Well, particularly

focused the broad-based So more are gives interferon we're [Technical us I immunomodulatory think so because modalities advantage these focused targeted. pathway that an on the over Difficulty]

Ron Mather

Great. so Thank much. you

Operator

Thomas from Street. Please Lake go comes ahead. question next The Flaten of

Thomas Flaten

for Hey, good questions. afternoon. the Thanks taking

months for cash least one XX runway the that XX accounting months, is Bert, we from or at to Just XX of perspective? XX think at least a that quick months should an

Albert Marchio

accounting the far. that from months cash means XX to at also out to have That's least go we've which perspective, an got

Thomas Flaten

Monica, intelligently, this to please bear struggling And I'm so Right. word really with me. how question but with

that So Is how different at atopic trying given a certain get see of path? PD is you certain indication kind to for that are Or grouping BBI-XX. versus know to data in mind PD really what you path tree really making have do a if works you'll wait the once autoimmune decision towards down you that will up see should that a other have pre there I'm your of hand? Are you this you dynamics there on of in before that that certain totality mind a a drive that go already versus understand dermatitis decision if one? you data markers, pathways established that? tree look to see the particular your you taking

Monica Luchi

of different a we by diseases, little look IL-X if instance, down us more diseases bit we [Technical which down to on impact see have slightly. Difficulty] path, risk to some answer being impact cellular with take benefit specifically. driven is an and pathway differentiate but our Yes, are Obviously, at take alpha need cytokines, of behaves if often it's -- more terms how cytokine when think are regards that to than the looking in pro-inflammatory of on some do at going look different a The driven TNF deciding about. safety a of difficult about there we lower might THXX, thing that pathway. from that to to overlap, know, so to the We'll we cytokines of intervention we're cytokines DYRKXA within able shift how hit an some in that populations question diseases cells, we -- what in diseases, well you we levels as one inflammatory ratios to might Obviously, learning others. see that we're more target for if you when need new kinds THX If target take need we flow human. on we're one that's have actually us

said unknowns have right say there's so we then are there can't balls many we path say I unfortunately, to if that different So, many in to and valve that too specific, and guess, I'm sorry, this that now they definitive just we we'll the up bit have lay our line early. make see can't then, just I they see air, more -- it’s it’s where be then. a all see I and how decisions little

Thomas Flaten

No, one, any Yes. absolutely the or see the pharmacodynamics what that there risk that fine. a treatment consequences hoping final you'd that's efficacy for one And then is days of of the is XX if to or an or of some see early simply signal isn't be downstream treatment? enough

Monica Luchi

[Technical can't a what question, answer. good question and Difficulty] I really

know, and drugs a X and takes chronic there you outcome As that you impact already get some ultimately, two giving to XX weeks. it's long-term well there. there AD, weeks, get you best if that bit And have little you and it is are to an are diseases four the you wait there longer to that to are a

are to wait get fully better the patients to Sometimes waiting to in order outcome. for that

the after way to we'll buck this We efficacy. going think go. not that weeks a show we impact, that don't four question. want we good all have we why bang preliminary that know So with this for how a little program, don't to don't to We ourselves. that if DYRKXA but that for of consciously we’re will were a get its that's strictly the want the about is assessment us is don't biggest give and And AD to bit learn along said sensitive

days we're starting will our subclinical be So starting longest is conscious very actually be going going mine. and the to tox that our fact The be limiting a that's is XX to of where factor imminently. -- we're

Thomas Flaten

Thanks so questions. Understood. the I appreciate it. for much taking

Operator

end for session. the like reached Mr. the We've call of I'd over remarks. closing Brown our to Rob turn back question-and-answer to

Robert Brown

Thank update. autoimmune enthused forward. the time what cutting-edge taking look and our progress from patients you as to inflammatory development debilitating, We're about updates to afternoon suffering treatment to for alternatives this listen holds We a the biotech future forward Brickell moving exploring for sharing additional conditions. on for our

As questions. any you reach day. always, please at further feel out to have a to us if time great free Have

Operator

today's concludes teleconference. That you. Thank

this your disconnect today. line now may at you your for You We time. participation thank

Fresh Tracks Therapeutics (FRTX) 11 Aug 222022 Q2 Earnings call transcript