CELC - Earnings call transcript Q3 2019

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Operator

Good day and welcome to the Celcuity Release of Third Quarter 2019 Financial Results Conference. At this time, all participants are in a listen-only mode. Later, you have the opportunity to ask question during the question-and-answer session. [Operator Instructions]

It is now my pleasure to turn the program over to Mr. Sullivan. Brian ahead. go Please

Brian Sullivan

Thank results joining ended for few XXXX everyone. announced September call. the a ago. financial our minutes you afternoon, our for We XX, Good third quarter

remind filings we press in everyone include Before release forward-looking statements and and of These with our a statements. I'd outlined uncertainties though, like which some that comments are the today begin SEC. our will number risks and involve reports to in today's

these forward-looking differ may actual in from Our materially statements. those results

On call, refer some this will we to non-GAAP also financial measures.

press GAAP the months You website our for our measures a press XXXX, the under release table www.celcuity.com can included at Today's release September ended find non-GAAP Investors is reconciling financial earnings available was section. nine measures to today's which financial on three the XX, and months in in release.

as on open I'm call third to make also some the comments questions. I'd general the I'd of today, Vicky results few and as follow with line our to discussions projects, our like collaboration have our CFO. Vicky our trials. we clinical for our outlook. In more to first well pleased status then will and details on up particular, provide a me on with like Hahne, quarter items product a development review the will

discoveries oncogenic discover tumors those to hyperactive platform enables us our we've this the As have subtypes many corresponding new into think pathways, unique patients diagnostic talked genomic cancer and in absence the gives of us CELx whose And to I you understand despite past to tests. translate of biomarkers. and ability the identify signaling

the to to are of of cancer patients significantly subtypes CELx a indications in discover and solid the XX% driving for multiple signaling types the diagnosed. we Each our dysfunction the for new test diagnose better potential goal offer that tumor the for can Most number treatment population the Signaling evaluate. drug cancers new new therapies. the outcomes Function and targeted expand enable of test tests for indications Our are up importantly,

San into continue R&D preclinical CELx tumors subgroup cancer test. for at genomic that oncogenic next subtypes to the will new Cancer's results patients We'll several December, This will Antonio Function cell report not for cancer to activity. teams our conference. patients of Breast undiagnosed breast Signaling Our Signaling Multi-Pathway our breast diagnose advance cancer identifiable with we currently a with HERX-negative study CELx Function test tests. this have signaling test identify incorporate with development In breast of new tests test hyperactive

of subgroup and therapies CELx HERX-negative cancer the HERX can will XXXX. these test test therapies expect cancer our on for companies one light-phase that there a diagnostic collaboration breast first would treat for would expand are in initiate is approved pharmaceutical represent We population in provide with clinical increase diagnose. first clinical can opportunity the half companion treatable development of And this the diagnoses. about our beginning that partner's of proportion as therapies. potential a with the patients Each trials tests, subtype collaborating Celcuity the discussions two Multi-Pathway to targeted to

targeted If tests expand potential progressed opportunities the breast our during development and treatment the therapies. number of for advancing for types additional we to companies pharmaceutical obtain of the create this two HERX-negative to of also new tumor We're The would test successfully population quarter. a test cancer new in indications complete for this that development hope also fourth XXXX. for fourth developed

present quarter type the a conference second the XXXX We the studies cancer and of in the these expect preclinical our of to research in studies Function complete quarter. Signaling results for at in tumor test first cell second

further increase to to or obtain for will preclinical data cancer diagnosed. the we provide will of pharmaceutical diagnostics tests that companion completion indications The our for the drug believe companies tumor opportunities type new package subtypes second enable the

Our made to efforts type development this development test progress to the quarter. in advance also significant sometime tumor of for hope complete We this of in test third Signaling third in Function the tumor XXXX. type

The we're developing tumor in breast tests these many in approach new for ways our cancer we used tests. types the approach taking mirrors for

tests is studies can leverage pathways we the available version when experience in hope tissue enable new data these to we for and cancer. With the offset. in conducted types, the And at initial us of we've Multi-Pathway we the test announce test this The pathway offer will breast multiple it.

will of could collaborations broaden We we the pursue. potentially scope

treat finalizing to our combination We by would, cancer to CELx collaboration with sponsors the successful agents. is four test could population towards enable and companies, us study potential finalize These the we're MP to to of or believe finalized, involve lead collaborations our three single clinical the to helping and companies pharmaceutical these collaborations also therapies agreements if pharmaceutical required the breast range Since some the drugs continue patients gain Celcuity, test. clinical parties. these a If sponsor identified related collaborations ultimately progress time identifies. significant in FDA either pursuing two patient several or approval trial clinical cases as to we study between

next will that we're several quarters. However, we confident collaborations several close the in very

that Test. HSF of and evaluating early in to a trial other that approval-related is IRB year-end. now Institutional of four will are new The in who Six Celcuity's all another efforts midst patients of that activities trial. ready are quarter. We are Genentech's This have successfully the sites efficacy selected most and to And chemotherapy be of enrollment-ready drugs stage not sites, approvals. FACT that or by breast and clinical if with remaining enrollment the X Herceptin the activated Perjeta reminder safety the in sites Board the this we're and cancer hopeful by is CELx Review various approval trial one sites and related IRB continued sites FACT four obtaining add XX stages clinical new NSABP obtained at

these compared of trial haven't for rate of patients had to The double addition only activated and Since sites would end most four enrollment impact of pending of sites participating significant yet they new for these patient the began trial. the on sites recently, the number this sites six the new enrolling XXXX.

expect is progressing. in trial with results Puma stage and interim inhibitor months of will the be We breast nine safety results available trial is this and cancer in from final X patients mid-XXXX evaluating pan-HER also early HSF Test our efficacy The Biotechnology’s NERLYNX chemotherapy CELx ultimately FACT selected in later. that

this The and trial Biotechnology XX later. with evaluate inhibitor mid-XXXX metastatic interim expect Phase progress. in results Genentech's and tissue Erbitux Puma trial EGFR NSABP approximately We evaluating from final Squibb's from Inhibitor study colorectal HERX to a patients Herceptin; Bristol-Myers to in and pan-HER samples cancer also antibody NERLYNX; Puma's results months continued II

Business industry excited Eric We Celcuity's with companion our team oncology our just the foster expertise thought in to relationships but to and Chief Officer to have diagnostic critical on brings to Finally, join efforts comment announced wanted establish this Celcuity. collaborations previously experience of leaders. nearly two with as decades Eric's I Lindquist very I'm lead pharmaceutical companies to it. to

He for he diagnostics oncology company. their pharmaceutical than was and and prior company. testing leading During Signatera Natera, diagnostic developed of his recently to tenure was oncology agreements launching executed XX launch. pharmaceutical responsible industry the first product a when more year Signatera there he the genetic within diagnostic joining its disease And companion to Eric nearly every President rare for leading us, companies, most the major several diagnostic of relationships with was at Globalized

quarter. so, And And we're it remarks. excited that progress concludes over I during now will turn results. the my to to our about Vicky made Overall, the review very we financial

Vicky Hahne

Thank Brian. you,

$X.XX $X.XX net quarter was the compared $X.XX $X.XX months loss the $X.XX third per period share XXXX. share third or per of nine Net for $X.XX $X.XX per to the net or million, million for of Our loss million share the in compared year quarter XXXX. $X.XX to per share, or million same first was loss or for

loss we a for stock-based losses press Because these non-cash release net net quarter. significant the included in item quarterly non-GAAP our include compensation, adjusted also

non-GAAP million million of $X.XX share per quarter for loss for third compared XXXX. quarter adjusted third to the was share non-GAAP or $X.XX or Our of XXXX per net $X.XX of net adjusted $X.XX the loss

increased during expenses costs and months in validation development million nine expenses compared months nine first laboratory clinical of first to $X.XX the of the to XXXX. legal to $X.XX studies, XXXX patent R&D approximately primarily due operational million business and activities. was This and related

compensation and tax development increase million non-cash provision. and tax $X.X of PATH utilization decrease of This by the in resulting research credits taxes, in stock-based from as million decrease primarily authorized payroll Act by offset was a $X.XX

from resulted associated XXXX a approximately XXXX, first non-cash the The professional first from and nine months compensation compared company. nine million of with $X.XX the of primarily in decrease months stock-based being public to fees G&A

ended changes used payable in cash quarter for expense This was million, million depreciation cash offset of million. equivalents accounts prepaid working operating investments. of approximately million. XXXX loss net with the in by result quarter was activities the non-GAAP $X.XX the of We third a net adjusted of $XX.X of $X.XX cash, The and and and capital $X.X

Brian Sullivan

questions. now Vicky. you, And, we'd to Thank operator, like take

Operator

of Instructions] [Operator We'll Yi HC go Chen to the first you. side with Thank Wainwright.

Edward Marks

on questions. This the Yi. I for afternoon. Marks appreciate is taking Good Edward you

out a you detail. Just you looking for but here, the wondering the if Most or them on frames for can granularity the readout timing the more anymore collaboration be. if may I'm laid are multiple for wondering here collaborations, provide of you had out Genentech laid time that just trial at the give I'm Roche can what little collaboration

Brian Sullivan

That's as the months then, Well, mid-XXXX. roughly we as can final readout, think, we that. as XX And just not indicated, said specific after we I get. with

by of coming the will And of the now. that so, are essentially online a be augmented it's that we and enrollment hope addition the new sites function

Edward Marks

you I'm able going the wondering announce some several break within Thank conversations having anticipate could And next Okay. to the these into additional the in down then, anticipate indications near and to just or you to collaborations. you're you quarters have if then the in quarters four three if also different mentioned you. you these next them. term, just or just be

Brian Sullivan

discussions stage, having agreements cases, that in follow-up the I and time agreements drill meetings, to potential and or don't the pursuing different think we preview can result pharmaceutical is we to had companies. are just collaborations it's a six of are But in we're have take that -- want longer a these just or I my We're ongoing drugs some deals to on feedback Well, multiparty a they those They as we remarks, or confident cetera. of that different happen, conversations getting announce. time five with as of lot indicated lot those practical. done. say don't indications because et different -- until a and really we've just will But get

reality the a to pharmaceutical confidence of just a that collaborations I mean, these But few in will we great far those have discussions, XXXX themselves. some the will think we have in the number and be world, -- of It's for regardless, of because we're them enough the quarters. announce that of to in of have nature us next number along

Edward Marks

Understood. Thank you. me. for all And that’s

taking I So the appreciate questions.

Brian Sullivan

Thank you. welcome. You're

Operator

go from [Operator Instructions] Craig-Hallum line Capital. We'll Ostlund next Per of the to

Per Ostlund

Thanks afternoon. the taking Good for question, and Vicky. Brian

Brian Sullivan

Per. Hi,

Per Ostlund

since continue subtypes I ask, that for future to the we're talking is collaborations test. additional you'll essentially the multi-pathway right guess, and I'm pan-HER, specifically the test. to test iterative c-Met Wanted the in Multi-Pathway test add If to about sense

can way. can holds and In that assume and to with you from when striking you else add a nothing other down as c-Met, fourth have collaborations, tests the pan-HER the you collaboration you then tests back fresh something it coming strike add road, third your I there's you -- along words, that

Brian Sullivan

Exactly.

Per Ostlund

-- collaborations.

I on a And I figured sense. but do you're what you there. have that's Okay. that because makes working would expected, clearly That clarify lot

couple up I'd You the bringing but I in know of early take, your business to kind standpoint. for you remarks, a only of been I guess, love on Brian, prepared brought table your hiring and a he's development it's what months, Eric's from

got it maybe bigger conversations another bit high-level then, does picture those a just matter the just executive his partners? little is being at because having alongside? out? And with of you've a table deeper, how pharma background conversations stand more Or you Are

Brian Sullivan

Eric Well, is a in Sure. on call. listing this

companies The that after candidates past very lot earth the working XX are were extensive approvals tests exploded. So with that drug no, I'll we did to good in found years search and of an call. have down companies their a a really has us. But to bring him to to diagnostic companion very molecular over get who of back select important for lot interested national industry There offer patients. the are

of pool and disciplines developed medicine, companies FDA a or across groups. pharmaceutical approvals the area medical careers group the clinical executives in good in with preclinical relationships range biomarker out And and coordinate affairs, who've with so there's people discovery pharmaceutical I a senior process collaborating there whether translational spent trials, their Phase the to even group its of

incorporate And advancing amongst helping the diagnostic number of Eric of advanced most so at and the He development pharmaceutical that major the so minor tests meet and what the from the gave generation most most to tests evaluate on amplification launch national HERX at companies was the pretty new good was And been out Eric using me I I involved people. he's involved FISH most very, think had about to Natera, of of His opportunity in very, was their could a those very because into of new the the very readout he And available HERX he'd launching how in companies first that a available there. to involved I technology the programs. impact with recent ISH. have capable next that of search because stood really to us. had in people and directly impressive a companion think and very of to tests I the forefront it their and was tests intriguing a entrée to the directly in HERX helpful chance us was to him of pharma technologies. development lot fortunate a of drugs in evaluate focusing candidates the experience senior talent very was lot test And and out. or the on I take of nature select experience be

somebody with industries a with to than And a lot you know dialogue in start it's know as you a better most that stranger.

to he that think of he having how a join benefit great technology understands of know to you is companies has our get having new in delivered And data reputation in credible team can past. presenting Eric your brings knows and should as I the the to people so and And company. worked the we is the discerning And have result. be overpromise. he because that from he the has with very he's that companies those in credibility a you're He he he honorable

a get but allows us And on terms were there's we've of than So in directly, certain helps at areas able relationships companies out getting also to within we how the with it of Eric a higher pharma. levels to Genentech, get Puma as we to made lot broaden our and progress maybe company us reach focused pharmaceutical there. may of have before.

collaborations with collaborate him I for our time hired reason these help a So overall to over to ability we advance our or establish relationships companies. deepen and think ideally these

invitation-only at in the couple And so conference and spent the only do. of high-level engage so strategic company way the conference, a non-pharma were able a with very to of a at days folks were -- we and that conference talk a very We we type about where work good. far at we

would can I hear it reinforced XX again he you for decision. days So but has my say

fits when great the Eric you no will that a profile And I things talk set will I initiating But out he's straighten on he I And this the So search. to have and board. had to really after I guy call. have exactly out exactly. was

Per Ostlund

calendar anything levels that Perfect. just of Very you an XXXX? look telegraph, is realize little from plan to might early a your would turning early as operating Last deviate hear. but standpoint XXXX question. from I expense/investment good to this the into bit And to there be

Brian Sullivan

guidance we're spending. extent No. always direction doing things I XXXX we're -- think I we're overall our I ball. And to and it'll very or the in XXXX budget money we we're so conscious mean frugal. more No, some changing the that -- are our advancing that spend good But not because vis-à-vis be

Per Ostlund

Excellent.

Okay. Thanks, Brian.

Brian Sullivan

you. You're welcome. Thank

Operator

Thank not this you. appear further time does questions any we [Operator at it And have sir. Instructions]

Brian Sullivan

talk the for future. you you to Well, Okay. Look with later. speaking I'll forward everyone joining in to thank call. the Goodbye.

Operator

to to line like Please your for day. in their thank have participation and We'd today's disconnect free anytime wonderful feel conference. a everybody

Celcuity (CELC) 10 Nov 192019 Q3 Earnings call transcript