BBI - Earnings call transcript Q1 2022 | Fresh Tracks Therapeutics, Inc.

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Operator

Greetings and welcome to Brickell Biotech Inc. Quarter 1, 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. to LifeSci conference Advisors. like host, to now Russell, Garth would turn over the your I Thank and you over to you.

Garth Russell

Thank afternoon everyone. good you and

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

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

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

Robert Brown

novel thank inflammatory joining that us our call candidates. business our transaction autoimmune of and for and new today. an you completed afternoon company a therapy to as for strategy everyone as exciting our and develop is Thanks, time Garth. we pipeline Good reflects commitment a This recently

In receiving at to believe lead develop Phase to what through development early We next these advancement up stage operational stage XXXX. while experience future a potential track pivotal NDA well new SB in our of XX The eliminating near-term deal set This of success first-in-class required for ability of invest related the a the of of the milestone Botanix X the eligible Brickell plan terms all through continue of million an and as sales ranging high next the anticipate is payments that and an Pharmaceuticals. and earn economics Brickell start and move to the generation of includes from to single we which teen primary out digits treatment proceeds of the submission our potential shown record mid regulatory first-in-human Just of early primarily X lead sofpironium last as kinase therapy as study up axillary through from sale allows for Under announced commercialization. from closing, immediately studies over Botanix. of from tiered transaction our through week, our the programs. to imminently digits. $X SB X and positions payment bromide will net Botanix preclinical FDA therapies. SB, inhibitor, novel team's sales, $X unlock had regulatory as the payments our investment SB successfully STING payments topical to review to is million assets milestone or on acquired Brickell BBI-XX, million, significant this We of based additional deal, to SB $XXX to us for we short exchange to an preclinical promising to and and value up company advancing Botanix to Phase potential hyperhidrosis. inhibitors to received developed studies inhibitor for upfront to in successful development by lead is directly BBI-XX, clinical receive the our also regulatory gel months and execution, This the pipeline Phase DYRKXA

Now, I'd Monica, we ongoing Monica? don't an provide pipeline like can on think our to to over activities. Monica I update to hear it pass you.

Monica Luchi

I'm sorry. Is that better?

Robert Brown

Yes.

Monica Luchi

Yes thanks Rob and and good afternoon.

Robert Brown

can you, we you. hear Yes, thank

Monica Luchi

Okay.

team on drug thrilled candidates and just the novel inhibitor potential clinic generation to be is our mentioned, of inhibitor immuno including fully development novel first-in-class inhibitor, platform. of focused BBI-XX now advancement As in space, preclinical therapeutic our and into STING DYRKXA the next Rob our kinase the our

to for orally the development DYRKXA lead is program planned to and and Our promising diseases. we adaptive and this a and data paradigm been dual highly could modulating scientifically diseases. validation BBI-XX represent systems selective range debilitating these on immune mode Based that of preclinical compound way with inflammatory shift broad bioavailable we of that's package the currently autoimmune action treatment BBI-XX in a innate stage date, that believe we of treat the the robust observed both inhibitor a develop

calling the As initiate X in which are to touched Rob we're track upon, BBI-XX-XXX Canada Study. the or of month, Study Phase on XXX we clinical later this trial BBI-XX

at MAD Part capsules a multiple placebo. dose healthy administered one or enroll of the ascending BBI-XX one assessment volunteers single quarter enroll to trial placebo we of the the center. SAD, is BBI-XX first is or daily Study submitted study a designed XX volunteers to as to at and of of short. for assessment atopic application XXXX, tolerability, of capsules During with of authorities, Objection planned. is expected study cohorts SAD The from dermatitis Study received in have or expected across for the Letter health over The center. and and is seven healthy once part XB safety, randomized, controlled the allows study capsules blind, AD study total pharmacokinetics BBI-XX dose proceed is a part or XX to a which XXX clinical XX evaluate up Canada, Health to pharmacodynamics XXX a No of trial double the BBI-XX subjects since both to The placebo XA the successfully we of a across MAD three Part days. or of also healthy the cohorts ascending volunteers

STING Finally, days is part in study which is and and of With of of currently exclusive rights signaling of XX will stands initial also steatohepatitis responses. NASH through are currently a start and and this companies compare Genes, from atopic to erythematous, inhibitor efficacy established lupus, as Part unmet Biosciences, expected centers our inflammatory the or will mediator assessment This as anticipate weeks, of line genetic space well quarter SAD Carna we high this number of for an XX program, STING, rare systemic immune to a as disorders and expected well-known established pharmaceutical BBI-XX, early the a enrollment inflammatory of from With innate need to include acquired interferonopathies. mechanism we linked resulting dermatitis, for key year, Several study STING Excessive Stimulator autoimmune such potent nonalcoholic the investing available to X is that covalent looking in proof to in and of of Interferon activities over approximately as portfolio inhibitors ranging tox AD STING PK profile. already diseases, of are enroll in respect development STING to preliminary and a of placebo dosing. patients has an for inhibition XX model moderate-to-severe shown significant of company STING are our forward pro-inflammatory developing patient favorable XXX BBI-XX are and across palmitoylation. which strong patients inhibitors to we parts through with safety in underway the differentiated STING Preclinical believe generation next in disease. initial reduction the coming global reporting study results from these top discovery XXX XXXX. we by first cytokines, MAD inhibitor their orally lead drug pharmacology Japan. a this of novel, dermatomyositis,

studies to We expect rest IND to continue XXXX. for of starting year this throughout activities BBI-XX conduct in the enable to enabling these

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

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

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

Robert Brown

we you. Bert, hear can’t

Operator

hear can you. we Bert, Hello,

Your line is ahead. good, please go

Albert Marchio II

everyone and thanks, Okay, on good the Monica day call. to

encourage as XXXX for equivalents as investor results, cash contained website SB. financial of and I to consolidated want cash to the fees full section report million with a I month, Earlier related SEC. which the in relating and million $XX.X through March once reported MD&A upfront development Brickell company can by SB, received as our the Brickell provide financial XXXX. be certain cash, first agreement $X purchase filed read XX-Q, statements Form with accessed to on XX, with in our you Before Starting expenses for Botanix incurred reimbursement our the in of to the well this of quarter summary

which of sales of for of XXXX Kaken. in for of revenue by quarter to other payments We next regulatory our million of the equivalents upfront the consisted operations partner will $XX,XXX months. at support from our ECCLOCK as of we near-term the Botanix prior XXXX, expect XX expenses of potential quarter cash $X.X both first fees cash Japan, royalty XX, SB for the were and year, March received related compared $X approximately of Revenue for million first $XX,XXX our the milestone and first to quarter XXXX. from the quarter for first or we to agreement compared purchase combined least recognized with Gel X% the was the R&D

quarter miscellaneous $X.X Brickell’s related prior XXXX. by of million and During expenses. platform Gel million to to $X.X was compared of the SB $X reduction U.S. for inhibitor which to in for the clinical million almost offset personnel quarter This related other totaled to the was first year. to X acquisition for compensation we upfront insurance, pivotal incurred Carna, the the the fourth G&A clinical $X.X This professional STING increases a costs primarily higher increase other was first $X.X of BBI-XX costs this and decrease expenses, costs related from year, the in and completed quarter of million XX% related in development due fully to related expenses. first of of fees, program in million quarter $X Phase million XXXX,

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

Robert Brown

of pipeline Bert. on evolution, as by financial of drug business company's with one our in year immunology and the for now developing executed past recap a This strategy update we in new and field Thanks novel and defining the a was our candidates potential inflammation. broad acquiring

results forward, Looking significant the milestones shareholders. beyond our we our next of and the believe inhibitor have topline and XXX quarters create BBI-XX, remarks. value important we generation next of opportunity to few the This a kinase near-term for from development over study program, concludes includes the several prepared STING and BBI-XX, platform. SAD/MAD This characterization the including further that present and inhibitor

open the call to for questions. Now operator I'd like to Operator? ask up the

Operator

Thank William first from Blair. go question of ahead. and with you. Thank So Instructions] [Operator you, Tim line the the comes please Lugo

Unidentified Analyst

on questions. for the [indiscernible] for Tim. is this guys, taking Thanks Hey,

second, just more the maybe Phase made? change details just has and behind in the the there any you the around wanted year can is to remind BBI-XX, then early, language it's and manufacturing in How timelines the readout from much what’s if already on noticed language maybe there? you I Phase So year have or manufactured early us late X? little for if the the or to have something And slipped you the chain get or a on by supply this color just some it where of of how end X around XXXX change

Robert Brown

April. the that initially We’ve study for broadened bit end the had primarily a that in And are guided intended. you going challenged weeks started had it's or we've the because it start to has that chains but really things little of given of of the little always questions. to guiding starting Thank are product just in than some early, end is of we because a with sure. been hoping on. for later the and at a few QX, supply been get that and the to year earlier Yes, of the Yes, we challenge

and the chain the we're Canada we just for In study. terms the really the of this we in now They're haven't guidance, made getting the do product, for provided do process we supply materials but study have going get of all -- that ready. that through

weeks be done the little -- We end to any guidance decided with this problems give year, to lost more study few breathing of shouldn't but certainly in more get goal our the that. we've certainly chain, supply that with we there is So by a the a room.

Operator

the you. question of go Please ahead. from comes line next Thank Trevor The with Allred Oppenheimer.

Trevor Allred

Hey, quick taking thanks guys, A for good afternoon question. of the and me. from ones couple

any measures if preliminary you going rest off year? the BB-XXX idea know study? going efficacy two, kind to have you're you move then that the for expectation the now how of do the down evaluate and X is are Thanks. have So SG&A Part of do Do And of R&D you any SB the books? with the to

Robert Brown

ask answer that. Monica Let part second me of do the I'll that and part to the first of

in than $X quarter clearly in We coming had the for be fee million first SG&A, will that's the the BBI-XX. so the was and R&D it R&D the Carna acquisition, a higher the quarters. On

upfront In with Phase made get were the X there addition, BBI-XX some to we payments program. started

we you be things obviously, some the in So our anticipate up and as show R&D the probably covered given expenses the significant some bromide well in would not R&D few see events would expenses substantially in R&D over next the first the Botanix off game. line reduce there quarters. of quite as one-time quarter, as books, now SG&A, The those would at we will have as that stage this by sofpironium that being

you evaluation efficacy of it's study just first window. is and In that, say this remember off the XX-day safety the a of a terms

the be see it certainly Monica some it is of we that, turn to purpose some to And going are the not let part hope over specifically. of results. we measures, answer more doing So study, efficacy but me primary with to that but to question the

Monica Luchi

during that thanks, this this Rob, of safety this out also, a X. Part thanks really We're is all and PK excited with All learn right, drug the for to pointing study. about phases

Part chose we're you inflammation, ongoing inflammation. the the of which that's we able DYRKXA which X, multiple measures has During asked on of specifically why about, population patient to assess impact so

the themselves be probably composite things We'll dermatitis, on at assessed familiar be see looking at populations at also We'll can looking EC also tape So looking situ measuring the you're PD for that clinical DYRKXA will such be only not the we stripping, surface from at activity ex vivo. be also on will in in involvement of endpoints inflammatory as cell by any we and particular. which with, the at markers different look and cells, results atopic endpoint RNA. we'll so area, looking targets body impact be as such, biopsy. And markers we'll on

Robert Brown

Is helpful? that

Trevor Allred

it. Great, yes, the appreciate thanks Yes, thank taking you. question. for I

Robert Brown

efficacy indications on that efficacy, during Yes see and we're see that and optimal X. Trevor so last to XX one comment it's one. of of the signals we're remember other Phase early to Well X trying necessarily but only trying days, rather, not Part

Trevor Allred

Sure, thanks.

Operator

of the Brown, Thank back like would Officer session you. have and the call Chief to closing to Ladies turn you. for reached and Rob gentlemen, question-and-answer Executive remarks. end Thank we I

Robert Brown

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

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

Operator

This Thank concludes today's conference. you.

disconnect for may your Thank your lines you time. at participation. You this

Fresh Tracks Therapeutics (FRTX) 12 May 222022 Q1 Earnings call transcript