CELC - Earnings call transcript Q4 2018

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Operator

Please stand-by.

Your program is about to begin. [Operator Instructions] Now I would like to turn the call over to Brian Sullivan, Chief Executive Officer.

Brian Sullivan

Thank you and good afternoon, everyone. We announced the financial results for our fourth quarter and year ended December 31, 2018 a few minutes ago.

I'd include remind some though, comments that begin will today forward-looking I like listeners to our Before statements. our press And risks these and today's and of filings in release uncertainties which the statements are outlined involve SEC. reports and number with in may those in differ statements. the from materially results forward-looking Actual On measures. this refer financial we'll non-GAAP also call, to

our was and financial our call earnings which release as questions. You can line year the in is and few outlook of on reconciling XXXX XX, in table included many on on months fourth items Vicky follow variety a non-GAAP financial Vicky general details December the Hahne, under today on then like quarter release. well measures the release significant our three XXXX. six, Investors press provide a we'll to find a measures XX ended fronts results the to objectives. our section. for achieved Also me And Today's GAAP then progress and available is with today's for the a critical website, of XXXX, CFO. our in with We and for made press will some www.celcuity.com, full on as I'd more make few comments open

accomplishments. Our pharmaceutical following platform I overarching and CELx note goals our would were and clinical the expand to advance particular, collaboration. In

second HSF a as Foundation. and X FACT X, trial II And clinical antibody, from signed samples Center Puma's in cancer evaluate inhibitor, conducting Herceptin, Bristol-Myers study NSABP metastatic inhibitor, clinical in drugs Cancer safety a also Puma's and Nerlynx they're safety of Fourth, FACT Celcuity's selected Test and clinical to and selected HERX cancer breast we activated capability with HSF to and evaluate platform trial to trial, tissue third, the Genentech's breast CELx agreement Puma Biotechnology activity analyze efficacy Celcuity's was to is X patients. efficacy signaling Puma selected that trial we by we conduct pathways EGFR test cancer. are Genentech's patients Test. with of population multiple patients in confirm Genentech Phase Squibb's evaluating NSABP HERX-negative a the were breast pan-HER to chemotherapy, first Test. drug, cancer development of and the evaluating II Our with Phase the colorectal And Nerlynx, HERX-negative FACT our of known with West and Erbitux, collaboration and the this expand can we We signaling completed for with our patient diagnose. function the of

co-activated patients, signaling second The patients family have activity. test HERX-negative c-Met identifies hyperactive who and HER cancer cancer breast and

targeted Genentech's has Conference, that evaluating function types. We breast The American Clinical in of tissue several sites. Antonio tests pre-clinical this Breast test clinical development signaling studies test Society trial Miami and also Symposium. at our XX to a San diagnose of finally, CELx Oncology, presented cancer advanced tests selects including for Cancer Breast patients sub-types, conferences, then CELx And third several activated including cancer the and therapies year new two Cancer and for we FACT activated now new new we major of the results the X is

to the add rolling The XXXX. activate basis this has process and patients has been expected XX NSABP rate, of half than expect quarter expectations. consistent total at rate began is below additional has at And to NSABP's XX of of these a this original XXXX, and to offset to enrollment far beginning sites. of lower While additional the with first the our a to sites, sites up sites goal activating to the sites agreed so enrollment began for new on

FACT the FACT trial by months in final for the of approximately The addition now up interim the selects from Review $XXX,XXX. later. We X later approvals to is therapy, received to clinical expect that and regulatory quarter, We trial test has X this our sites results evaluating expected Institutional Board early XXXX expect this Celcuity's and required and all is trial patients Puma's cost late be new XXXX. nine Nerlynx, increase results targeted in to activated in CELx

'XX We and expect results this in XX or approximately from trial results months interim 'XX final later. late early

objectives. remainder ahead of identified look of number we XXXX, to we've the As then a key

reporting anticipate X. and clinical FACT trail early we X in interim our clinical interim FACT first for First, results results trail progressing toward second from XXXX our

that signaling another function cell we molecular cancer new anticipate test. with detected development completing cancer sub-type not breast a currently for test diagnoses Second, of breast of

patients signaling Our unique cancer FACT to create signaling. An with patients not function HER molecular between detect. way. and year test co-activated this insights powerful c-Met we to pathways the CELx cross-talk allows different test family that signaling to platform driving of assess a example announced us a last enables very in this identifies the And CELx the that was the into could us

pathways, c-Met Our path, pathways could cross-talk HER between so and platform new to the not family we it. were but approach hyperactive, only treat drug allowed the characterize identify that best to this determine us combination patients who

two using signaling to additional opportunities believe and pharmaceutical efficacy We cancer our currently by does population. companies. one breast patients for c-Met of offer least approval year co-activated help new and or the we HER efficacy this CELx FDA companion to indications to number breast with in diagnostics or for our successful with for create companies drug productive activity. Third, the new their test to engaged end collaboration discussions fourth, a have at CELx and diagnose. pharmaceutical sub-types who first pharmaceutical study clinical if development We're new And therapies hyperactive companies identified these the us patient company obtain completing by MP tissue evaluate additional with anticipate provide We in patients the family molecular initiate the work to tumors. c-Met to hope co-activated these these for of we cancer targeted or And to patient types. new population tests we of to hope therapies therapeutics test enable that test HERX treat hope expand targeted to subgroups test and of and either CELx therapeutics tumors with patients identify evaluate opportunity of to gain HERX's biomarker. targeted patient cancer selected the Each beyond

identify cancer is are new of for and the identifying to sub-type approach us. initially to the therapies the not clinical populations on patient Our we targeted roadmap new interest

I'd expect for to quarter about our to Overall, So our of Vicky. another the year. while it break think us agreement. this collaboration like excited year. closing progress one and the we timing to next financial over made turn is the We we're difficult review it's it to reasonable To results, during

Vicky Hahne

Thank you, Brian.

compared million and million the $X.XX XXXX. share and million per period fourth per to $X.XX for Our net quarter $X.X was compensation or XXXX. $X.XX loss for significant per same quarter losses items, interest in share per for was $X.X Net or loss share stock-based $X.X net million XXXX fiscal Because loss share, non-cash compared include non-cash or the of to expense. quarter $X.X year-to-date or fourth $X.XX year net this

quarter. loss non-GAAP for We net also the include our in adjusted press release

fiscal for or $X.X quarter XXXX. CELx fiscal to or of of year non-GAAP compared $X.XX fiscal increase year XXXX. net fourth $X.X or share $X.XX R&D $X.X our per loss XXXX. loss for expenses $X.XX year platform. share or adjusted Our primarily loss to million net non-GAAP compared compared Non-GAAP for share development was related share million expenses million support million per $X.X to due XXXX, was during per XXXX non-GAAP in net per million XXXX, compensation This $X.X cents adjusted the to fourth adjusted increased for approximately net $X.X of of was loss adjusted to fiscal of year $X.XX quarter million

expenses in during with expenses in non-cash R&D the fiscal in compensation compensation. with studies, public stock-based $X.X million million, including year year and cash, million and one XXXX increased for $X.X during $X.X to XXXX, XXXX and G&A $XX.X increased, operational development and expenses In only fiscal in director resulted fees a being business validation professional compared legal addition activities. primarily increased from laboratory due ended Approximately company $X.X increase costs in approximately officer million expenses, equivalents investments. cash XXXX, related clinical to associated million patent related and to of G&A quarter Other We a full versus insurance. other and

Brian Sullivan

like All take right. you, Vicky. now Well, please. Operator, thank questions some we'd to

Operator

Please our take [Operator question Instructions] Chen. ahead. ahead first and Yi go go from We'll

Your open. line is

Edward Marks

This for Edward on Yi. Hi. Marks is

after FACT if future Just was I a end any possibility quick X, a the there for is on delays this year? of question wondering

Brian Sullivan

get we a is quickly we how expect how when quickly on-board. to and would results of enroll driver new The function patients of sites interim

what the dependent we enrollment are for to there we variable rate out, variables far could and if currently and on the good is the don't of it but So consistent Currently, push not major the making We're progress that we're adding with expect. sites. we estimates that But it. that's think occur, there. what enrollment new really that affect would expect to expect we be

Edward Marks

platform. And Okay. just on more the questions couple a

the you color little XXXX? of bit more little end you're your prepared MP mentioned could on for a You remarks. CELx the provide on collaboration a If anticipating

Brian Sullivan

Right.

Help announced inhibitor last launched have the year, have when to pan-HER with test don't anything opportunity and we announce inhibitor. a treatment to yet, we as for indication companies c-Met pharmaceutical get new a we so but an Now, we and discussed test the combination

where we companies what Genentech, making we're first to hope collaboration a approval that the process that is an drug are drugs we engaging would would of of step those take treat of so And anticipate would, in in the for that as form with There trial in place to We're discussions Puma we similar patient in combination front. put ongoing. select, to progress approach working, clinical of with efficacy we've been the their toward population with. be goal on patients. the and a The really the companies what number itself engaged has evaluate pharmaceutical the

Edward Marks

Yes.

exploring. on types provide two well? and you those types what maybe then potential question that tumor any more Okay. as And you final the types partnerships anticipating Can tumor little on a detail might new for just there be the tumor you are

Brian Sullivan

Right.

breast the model that and where be completed types and types development disease to studies confidentiality, basis pathway for we won't would of signaling indication. And new what toward tissue potential we tasks identify present. be with field range the selects, of the again the would but as would trial drug would the the collaboration, really that would a expand pharma for with done we have step the ready our is range the companion and dysfunction, for with to be patients tests for test diagnostics goal and the potential position announcing pursue expand our evaluate opportunities similar to collaborating to these test tumor We collaborations of we've and all development very to those CELx will to a just be in first we until us cancer, So new indications. partnering

Operator

have Ostlund. question think a from [Operator we I Per ahead. go Instructions] Please

Your line open. is

Per Ostlund

afternoon, Good Vicky. Brian Thanks. and

Brian Sullivan

Hi, Per.

Per Ostlund

originally behind to going having so bit. Is or been things kind enrollment expect IRBs go itself X, I can assuming whose specific is enrollment but target? of to want to there the hold getting in Brian would have that issue ground you breaking why a new of the little way I so your the so why we're point know enrollment. why in a had FACT up fluid point. this pacing there and IRBs to situation of the explain point bit that a to to Is there the is, back slowed be most I and isn't noted this a you is the it's everybody anything characterize pacing a there site understanding would taken prepared you this of NSABP's at little think terms remarks. versus that on anything IRBs short central to as that

Brian Sullivan

that same one not art with and trials predicting I if that you first, any competing over would test tell side that the of lead it's very chat are challenges each prioritize or you I, involved say are them enrollment to the most, in that to are trials with clinicians general involved may who in will Well, going trials after folks trial another some the were would clinical of patients imprecise we what to, in a Sure. trial. have cases

digging estimates. history really that into that the really and just And is When so, there obviously, are of some that how the those come of prior rules agree answer to of to will variance site of hard rate but have with use again we're this patients challenges is getting sites because are Their tell lot the reflection complicated you we anybody to really enroll. different associated each the drivers its NSABP that it's, eligible the a high patients thumb up involved hand on go are just in predict, this talk how and well is own on of And of for many in enrollment. it's business many with the trial estimates predicting there's and trial. in a would patient characteristics those that that factors based into there's one participate to a

through. used hard in and of, and many that the kind and of of don't to rules come simple On other it's hand those somewhat thumb it's cases predict are rules thumb

more do the sites that in potentially have reasons we're with. nothing getting to but working state For the really general do patients of itself with enrolled the with trial just trials that to

Per Ostlund

makes to discretion that rate it or selected the data Is that Is maybe to it is a be of up But what this data I we'll with therapy? will tranche comes to Genentech's went get discretion sense. can exactly going and the that that nature early data, That Roche's year. top terms or to when going the later the determine through were of Sure. for data? question PCR something an this they patients completely guess of be in you the different out. line release it interim initial characterize given be

Brian Sullivan

control at detail drug will provide announced time result the with companies and whether it's with depending line they, on If conjunction be line forum. research typically or would indicate met is more what a present in potentially more and provided they with announced part cancer on are to top as what essentially done has Typically, whether a in at not. detail a they results until but only the what's release conference Genentech NSABP at interim breast announced usually present released, and research like and in conference, the, provided. where in between endpoints If of or NSABP detail is the conferences. its data organizations a they or results more typically is track top that trial can

end ESMO meeting that the they there, it's data trial. the detail drug is And where companies I available ASCO data in would sufficient or with San Antonio Breast so detail indicate points even completion on before Cancer what But ex out or met and and meeting. they indicate whether to achieve describe with and to hopefully set a goals been more major we will of trials final European that the meeting think will we're achieve the met track to be have it their that whether and

Per Ostlund

it's place, Sure. reason level are or to good data final. guess whether Phase it larger in That that X data I that there But off the a steps the or at the Phase assuming dovetailing data, additional that, without good that makes sense. ensue does Roche that go And assume with a is of the stand Brian. a as maybe could of X to the indication potential just if next I seeking range from answer in that interim a outcome X? hand Phase larger likely FDA so is

Brian Sullivan

what more you'd what into they the and they're for for is and reviews data patients those in also some X can They the to with separate the can't therapy more more to and that so compelling and that they manner trials willingness requiring size identify obviously ways sample review they or to lead X recently for allowing the think but effect data FDA to as with trial thoughts Genentech good of a and of FDA drug cases get further breakthrough whatever they've sample a or the is speak to be when know pathways increase with would a the trial. be quick rationale a Phase well presumably Phase at And X I is can't Well amend allow shown a very, would designation for being that group the both would if when good accelerated put regulatory test. they pathways, reasons extent I reason on most the I in us that's and that experience proceed new have and have and like patient They are precisely very of our effective have I Phase possible. favorable drugs flexible Jackson changed they to made no but options. in have aggressive whether is as say all and Genentech strong would patient willing doing of focused efficient shown they to guess it, very safe only, do, do finding the least They expedited They size. are to there's the is all decisions And treated But When news approvals. what expect. an for provide data. Phase there's case market. the practice again, it's this available. Roche, several number options what population their with willingness just is have data the approved be data now and for or quick and would and review because X they of like larger about as a i.e. also X

Per Ostlund

Sure.

sometime collaboration during questions. context couple pathway XXXX. striking c-Met so test, on Okay. Excellent. A the One a around more the appreciate

collaboration? in be discussions sorts with between data and in in that looks for collaboration. when they the terms the at of to presented do with the, and the data good they conjunction how I that's pharma going Breast pharma you striking further, of going are little potential presenting to looking that been you're fall Are San and mature at How a here data gating data? think Antonio very in data what that Given to sort a promising thing. of presented I that be guess depth having that looking we there partner about, Are of additional say would for factors

Brian Sullivan

put together think we've package. I very data good a

that complete available San if interesting in published had family I package think about and powerful, ability to ways that's ability the we powerful very think are or this co-activated. Genentech than how have We're well pathways Antonio I intriguing It's and but really sufficient more new not our with that and pathways to pathway interact, HER a only an population. also rather understood in these what we these support not c-Met findings similar identified assess analysis and how in haven't how interact assess ways we very area. Puma pathways that's our to data before. as for And individual pan-HER unexpected have been

many is so we across groups that group, of these diagnostic individual the affairs, to within and at process I development, that mean biomarker There's those productive very in translational the science of takes group, folks. in time. understand individuals range an large There's a say, what, our many we need too compelling you making a guys these just R&D or yes move engage say those we medical it's very tend a get those We've we why have companies. decision so that's constituency that and of that all group, lap whether forward. pitch all least I departments a lot all organizations participate we yes there's and not pharmaceutical from. believe to generally in a all to have business it's and you have big work the again, ones, people But fairly and have why data. wide the to larger process a organization of conversations. and group consensus had then these it's would any dissimilar not the question from don't okay, And sense where jump that And

but that we have can again the this it's And so it different anticipate you current in These drugs year. two more this are we are why a makes us. than announce that's Genentech two that having a complicated drugs, also they're used But indication. different there drugs drugs, two in case collaboration somewhat

a two So drugs evaluating inhibitor, you that this today c-Met in think combination. can pan-HER as single really are decision. case, not we're In almost of different inhibitor used it

cases two collaborate to It through. variable So to more be that and again worked themselves, get one uncommon. again just that which different requires needs drug this in some together is not just groups

Per Ostlund

question. That's And this Thank and color. you all maybe a absolutely one question fair. be I last, then I of Vicky more that just for guess might last

last range So we've the operating well Is controlled to few range the over expenses FACT incremental the about quarters to over rate I few kind the the X think that that few addition quarters, we for costs or in be reasonable thing contemplating minus models? run ensuing talked of very, would say XXX,XXX be last is is that our something have plus vis-a-vis or should or we continued to seen quarters only for very OpEx the there here. be about in else should really you additional thinking about

Brian Sullivan

we've internal get we that's in of that raised XXXX. this of continue the $X $X end would did money estimates over We 'XX. period, would in Vicky cash suggests. the our rate to end current our that's I we take and the offering 'XX just And sufficient million first, what us time current million with either take can would indicated mean then add end budget XXXX color, what expectation we our be our is, would range, the three to that through so to that run I'll months average million from year ago the Yes. $X and XX the

the on in period the additional expect terms changed has track. the when $XXX,XXX expenses I in probably think spend. year year expense, but we look so we've mean three total at spend have we're nothing over come of this of under we to what we So site I our

Operator

time. Instructions] And any look this questions further we like it does at have [Operator

Brian Sullivan

Okay. and Well, look to you like like later. questions, it for no Good-bye. everyone forward looks thank participating with up I'd to more catching

Operator

does conclude Thank program. for today's your This participation. you

You any may disconnect at time.

Celcuity (CELC) 26 Feb 192018 Q4 Earnings call transcript