CELC - Earnings call transcript Q2 2019

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Operator

Thank you for joining the Celcuity Releases Second Quarter 2019 Financial Results. [Operator Instructions] Please note, this call may be recorded [Operator Instructions] It is now my pleasure to turn today's conference over to Brian Sullivan, CEO. Please go ahead.

Brian Sullivan

Thank you, and good afternoon, everyone. We announced the financial results for our second quarter ended June 30, 2019, 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 These risks statements and today's and of filings in release uncertainties which the involve are outlined a SEC. reports and number with in

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

refer non-GAAP measures. call, the On to we'll also financial

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

clinical provide have and we'll today. on particular, remainder discussions. details of our second line review product some I'm to Vicki also as with some then me few our our quarter status on results update call What as questions. for quick the CFO, pleased a the to our a on for more well general a activities like outlook I with is items, the our comments the will I'd give of with follow-up on and Han, today In trials, XXXX. development open Vicky do will collaboration finish-up

X began FACT of that X. our sites CELx initial late safety the from recall sites with FACT Process Herceptin identify enroll trial X the breast Test. selected NSABP sites intended And FACT total in patients. Perjeta, trial. patients last call, Genentech's added, and to the chemotherapy have we drugs, is to may you to efficacy and If in to its offset On were sites our getting will sites evaluating cancer all sites FACT disclosed met rates for HSF X Adding activated new additional required is approximately of in approved and the participate clinical that these these to enrollment XX lower-than-expected goal early-stage begin trial XXXX. activities the these XX the clinical

clinical sites sites second enrollment-ready. and During the to XX quarter, institutional their from this completed we're have board, are trial. participate IRB, activities in X approval review obtained now we related that means required other six new that the FACT And pleased or

We began in by nine and roughly Since additional hopeful compared and other obtaining sites [indiscernible] sites not of later. final in to of the the that most trial the enrollment in XXXX. new double come results to another early also months month stages trial this year-end. in that we of the of If activated ready than have sites the patients onboard for past approvals. various they've enrolling end year, nine will are will sites; related be this the nine XX IRB have rather only we [indiscernible] hope, as participating sites earlier approximately We're number mid-XXXX in

we're not proven optimistic all we our them in and challenging of from we've of number address on the enrollment. in believe, [indiscernible] CELx we the support the team taken to from Projecting to exempt as any We've future scientific about made discoveries in with sites, work outcomes of cancer at than have to the data certainly seeking double been. and action enrollment at are, NSABP several as trial continue improving fantastic by past the as can technology to enrollment progress made error, and our recognize impact, year, the delay closely We've longer company ever you important patients. interested obviously and clinical possible, as initially rates We're obtaining of notoriously is know quickly I challenges taking expected. we prone trial it's FACT to we've and X projecting the

Puma study the ready enrollment is planned, with to available but target therapy, us, Puma result was until its drug with a drug, late consequently start begin of The trial of FACT trials was clinical was couldn't but nothing the This wasn't making available, Celcuity, X enrollment patient do June. clinical early forward to the until was study had changes enrollment delayed. Biotech's approach. in made activities Nerlynx as April Since

– So now hard from result, later. results we a results XX trial expect in years No to final approximately mid-XX there. effects as interim early this and months later XX

two the trials to half us more think independent to swings we Function So gives to an companion efficacy for cancer of diagnostic is CELx what HERX on importantly, Signaling financial we In two a regimens, two evaluate with significant to and, the with opportunity bat test opportunities improve become target indication. underway first two other a connect patients. different words, treatment for outcomes new therapy at our opportunity have

We to third continued our of development also breast for cancer. advance test

cancer test. and not a with pan-HER with subtype currently our detected to Signaling test As our intended molecular HERX test, test c-Met diagnose a and Function this breast is of new

this new or test this the a incorporate MP, CELx of available to preclinical describing information expect Signaling The Multi-Pathway, be should study year. release pathway for available. end when test the test results Function We and into background by

a subtype As partners' there therapies. two each of represent diagnostic would clinical with therapies tests, a opportunity test for once first late-stage are population our expand collaboration development that provide treat approved to that and can for with companion the these treatable diagnosis Celcuity therapies targeted in potential cancer and the

tumors breast tumor So goal patient's to test. signaling each signaling was work we CELx analyze all function, would our pathways development subsequent cells to We pathway multiple consistent a in patient our have tumor and with analyze. project approach in proportion is may successful. This is XX% of patients a XX% of we current tumor. cancer types driving breast the with of this identifying cancer And activity hyper increase identified by whose

have we provide signaling we Achieving this diagnosed of year targeted profound to three the believe, a diagnostic how for opportunities tests other this have, for patients on bat. expect are By and therapeutic. impact a of cancer goal would function several which treated. companion end words, then, the a cancer, many swings In have hope each to breast will we to important have at

We continue to tumor ways, our these many we're for approach tests. in taking The use approach our breast tests the cancer mirrors, progress make for two tissue projects we for developing types.

types it. the multiple the initial Multi-pathways will these could scope bat, breast – types, new studies experience when leverage with in tests the the we the pathways pursue. and offer However, for is swings us potentially collaborations in We test we we broaden of can could This at announced outset. test at available cancer. hope version test of to conducted tissue the data, pathway we we've enable

first our continued identifies. pharmaceutical hyperactive MP gain efficacy MP cancer And the to these And family a lead and with would therapeutics new this collaboration evaluate towards the activity. FDA successful, progressing to will therapies study also of clinical signaling population. test HER we collaboration it We this believe to breast subgroups our identifies. That's what co-activated approval targeted companies c-Met test patients CELx and in if CELx patient helping patient treat with

represents us are advances drug a c-Met platform of treat with We're patients the our excited capability very but combination approach different the it. pathways test not pathways about between HER assess and CELx the This powerful the in best it further demonstrates enables to way. family to because to hyperactive, signaling cross-talk only also the identify MP determine

the To about our it to the excited we're overall, like to results, financial review Vicky. we I'd over progress made quarter. during turn So

Vicky Hahne

Thank you, Brian.

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

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

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

approximately due $X.X million to offset stock-based first during of $X.XX R&D million non-cash six decrease $X.X the months XXXX in of by the XXXX expenses $X.X -- first six primarily compared decreased increase to a activities. of months compensation six primarily to $X.XX non-cash first months and XXXX stock-based operational million million the during increase six G&A business compensation. of first the the from compared in development resulted XXXX in months The approximately

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

Brian Sullivan

Okay. Finish?

Vicky Hahne

Yes.

Brian Sullivan

now. we're to Thank Yes. questions Vicky. Operator, ready you, take

Operator

ahead. our take Ostlund from with Hallum Craig Capital. go We'll Instructions] Per first [Operator Please question

Per Ostlund

and Brian afternoon, Good Thanks. Vicky.

Brian Sullivan

Hi, Per.

Per Ostlund

of little out uncertainty in touch think just the of guess – right one unique Is enrollment estimates appreciate easily gate to of a the or inputs takes FACT – and guesswork IRB the and there's harder to is on and of timelines. that particular have to establishing go I can lost longer we a X. else? and trial, fly that Wanted are goes because out FACT shuffle anything certain timelines complicated lot the the it process kind anything a into Curious that X makes if the there into easier to the more unique where – like I of just the more if Or bit? just we there's that, those on all there's it figure and it the timelines things that than of process anything – degree you said in the or

Brian Sullivan

approval. pieces. do negotiated. required. site people performed, but more are Well, the is dependent to site And a lot IRB internal schedule a will needs be developed. forms the things. moving the But contract get the so work to patients that very the simply Sure. the the be that's on dependent internal that's important needs than most work get Different see processes, and on much certainly site's by site there's done of need And to required to get enrollment-ready you're to to of be to The there's different that one activated, activities

In opposed two month nothing has them, with every out though this you what you an just trial IRB stretches lose site as weeks. that we're the meeting depends. time. every It's sites. when involves on what really could or There's process cases, initiated months the some that about every – to that Depending two for doing timeline or

you the until something you out required. initiate not that what's know it's the into front about when end the Only do so on work details find them. get with you And you

site. somewhat but involved, only turn You're more doctor overseeing at around be the to will that's the person And just – trial importantly, they're who the ability not dependent involved the required. the on PI, paperwork just their

us than company. for for different So again, still really any that's – it's other

as far later-stage have. we're would an and that As than might new doesn't patient the technology have the a with same necessarily dealing early-stage say a enrollment I who urgency patient

the so of harder patients. is the specific with i.e., say That's early-stage that treatment to one to that's of nature just I the nature be think But accrue us. for. sometimes indication, people can not And early-stage would working

again, so concept. we think I typically quantify – in general, another first say, on. relying Subsequent us for or But can of sell But with onboard. point effect these you're a introducing again, because and the rely and a what be number new, the to to trials hard the I And studied on much detriment new can so this hospital why other initiated have system in technology. easier. And they're can say don't we and staff it's of lot process impact. trials to, the is trial is doctor happened are very and to much think is general, to have And because – the you sometimes we data patients hardest a a drive don't hey, the getting variable sites are we're data in people, the the sites, trials the of would which clinical we

the or to at very doing capable team I NSABP; I what supposed well-respected they're think the I it, do. are very any group. they concerns have about think don't shoulder group, and them putting to professional very mean they're I

about I harder enrolled with a the in, patients it's this it's other clinicians hard the think studies lament it they're to the – and we're involved nature around particularly, fairly somewhat we just mean one. the earlier you're the study – the beast. of I And just very or it's – – as getting be. stage of But project the so. to It's in, universal challenges can is talk

Per Ostlund

X. than the having little about the we're I – point easier standpoint I in fair. that's Does on potentially you've sites think know a FACT very involved talking all that talked the make reach that about top handicap. being educational number sites a into X other from just procedural thing from Maybe of Cancer because FACT and but kind that that try the sort limited to trial of back keep kind to somewhat on Center-specific mind, makes support just of to little West to of easier of

Brian Sullivan

Yes no. that still it's willing mean patients to are and I show have participate. up – find to

Per Ostlund

Okay.

Okay. That's fair.

get folks you to preclinical within or you've and – looking the point? variety progressing for organizations to done? at data a this work c-Met to a like just is test, really some that is number that that's matter of that the it of sounds it is additional anybody at Is is having just a of organizations. within like sort On counterparties of factor the this anything toward have talking you're Or really the these of point gating collaboration, wide around the it

Brian Sullivan

You faded of for it additional entire so at are didn't out the But process to I a working responding really I a question. we is information. versus it's just for bit – the a stage matter requests hear where think

think presented has companies together put pharmaceutical the to different I been be very considered the that we to and package complete.

ask for had haven't anybody that We data a missing. suggest data additional or was

we that positioned well. standpoint, from think So ourselves we've

internal black with to these companies is the a working processes box. pharmaceutical But

some different mean You are very different companies. these for groups. there And don't visibility of get obviously committees a visibility a are, and large who in on cases, have lead but lot schedules. I are taking people we

you're So they urgency competing. have have, whatever they the are subject same have. obviously, don't sense lot of have they we internal somewhat that projects timelines And that of to and a other

hopefully, a consideration in timeline and getting you just you're as and the a you're So possible. as hope queue, quick

to – because until and But the end. we we expect process it again, would passing happens, it's like hasn't detail it all into that's gates and to and again, why way to through. get the the through don't But you have just that we're happened a pass much get through

Per Ostlund

sense. makes That

Brian Sullivan

we're But working again it.

Per Ostlund

sense. Okay. That makes

no But Just thinking another the how obviously – general at a subtype? additional per potentially, about about I'm that trended have Herceptin in Perjeta to looking the recently, make them the more it as you're that U.S. se. talked important and it's finding franchise risk here way market. it's much what together franchise Roche biosimilars extending for you're not But of will at away. look Herceptin they in way where an and Does analyst doing and that important, and that marrying that they Is that of franchise further? going

Brian Sullivan

Well, to I I so Genentech's don't want put can't mouth, into – words I stop.

people. those are think very I savvy

the to [indiscernible]. drugs combination and they to I at very launching franchise by The Perjeta of think expert very protect or getting they their advantage and with leveraging Herceptin. Herceptin essentially protect for clever very companies finding franchise any can how about are were in Perjeta approvals them, to ways are initial important obviously pharmaceutical expand

Per Ostlund

Okay.

that? is to it ensue I types the leveraging or on words be rapid that? potentially mouth, in and multi-pathway out that Brian, you've collaborations commentary about work of your reasonable coming. tissue appreciate your tissue your an going cadence would maybe there off gate want you're type, from in words additional I done mouth, to don't but cadence more could put that with And cancer breast at putting If think of into Speaking a the a additional right the

Brian Sullivan

and in HER work Yes. could and make of collaborations c-Met period breast, – we more pursue time, simultaneously. than wouldn't to for the HERX pursue of case because test. get as initiate after would a have the sense That collaborations collaborations then, We we be did we

Per Ostlund

is quick will right. expectation the by be cancer that questions. talked know respect I end a And look – breast I that of preclinical then could and to the real year, With to completed data? got asking reasonable out way. would end San you the unveiling Is keep All towards year. I be a Breast that of Okay. ones, Antonio that, the place the two test, I get that being about of you next the

Brian Sullivan

typical that. introduce we That would be able to a would be to like something want place that

Per Ostlund

one. then perfect. Okay, And last

cash unchanged that are your You didn't around expectations in mention usage anything terms I assume of... plans.

Brian Sullivan

on XXXX. and our They're the so we mean into – projection right takes now cash assumptions think about track. I us the availability

runway we're if maximizing about being good we to So we our making have and longer is, a think sure we've step-down. timeline anything than the because just probably been, projected little cash I had far that good initially get diligent with so

Per Ostlund

Perfect. you answers. all Brian. Thank the it, right. All I appreciate for

Brian Sullivan

welcome. You’re

Operator

Please next Wainwright. will Our go H.C. Chen come ahead. Yi with question from

Yi Chen

my taking question. Thank you for

Brian Sullivan

Hi, Yi.

Yi Chen

cancer Previously And... XXXX. colorectal Is you any data trial the there Hi. in update that? mentioned on could report that

Brian Sullivan

Sure.

Yi Chen

during mean, you do I the process? have any visibility

Brian Sullivan

on for is and general other trial loop. not itself enrolment to step we're kind because So Puma NSABP, of we're analysis. And and be receiving tissue component. simply direct one in our don't we're or than that managed removed by how frank, activities get about visibility, interacting being The any trial we're the own so we in

informed been but in any that's haven't the timeline, proceeding. We of change

Yi Chen

confirm, expenses Correct? half first right? to the in to operating the that be the half, just And second comparable should

Brian Sullivan

Yes.

Yi Chen

Okay. Thank you.

Brian Sullivan

You’re welcome.

Operator

Instructions] [Operator

Brian Sullivan

and later. your thank Take I you, catching the attendance with you to care. Well, Okay. on call look appreciate up forward everyone.

Operator

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

You now may disconnect.

Celcuity (CELC) 10 Aug 192019 Q2 Earnings call transcript