CELC - Earnings call transcript Q2 2018

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Operator

Good day everyone and welcome to today's Celcuity Release of Second Quarter of 2018 Financial Results. At this time, all participants are in a listen-only mode. And later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note that this call may be recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Mr. Sullivan. Brian sir. ahead go Please

Brian Sullivan

you and results XXXX announced financial everyone. few good our second afternoon, of XX, ago. We quarter minutes the Thank ended a June

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

the our You then our June comments me second which more Investors our was can up have measures with will in earnings follow and financial a today release release. section. details some for line non-GAAP included in for the make open XX, call XXXX, today's I'll and with table on press on find Hahne, on few Vicky about results, ended available reconciling And Vicky press release the items, is the also months website, measures I we'll quarter the to questions. GAAP Today's under financial three our CFO. www.celcuity.com, a six

earlier current between this HER with Abnormal with breast in of developments And disclosed, our been cells. signaling we've As combine generation completed playing c-Met primary for previously HERX, new this second independent HERX cancer CELx pathway a types. involvement a MP HERX-negative cross-talk a for our is and c-Met function function HER signaling family pathway And receptors, signaling, CELx We test objectives. suspected or test year. the test With to in of its evaluates activity and breast cancer including test HERX, plan of c-Met signaling test. activity tumor specimen. signaling c-Met additional HERX the of signaling with an has cancer provide we analysis create test family and CELx tumor breast variety we signaling in long next single test, the c-Met completing development of cancer our patient one Multi-Path test role to of

pathways XX% of We’re evaluating opportunity our cancer for HERX function to breast signaling cancer. with new there an increase MP to to We current negative add the now untreated test XX%. CELx believe percentage total to patients dysfunction breast is to signaling diagnosed signaling

confirm have new identified test our work next remaining add development would new pathway to findings to year. We complete test. and be will to development Earliest, MP complete significant to have our to expect we we pathway of CELx the but candidates our initial still several sometime test, of

we’re furthering of for greatly to We companies with of to signaling to are therapeutics pharmaceutical support And as dysfunction. types. projects, breast companies. pathway cancer. in and gained multiple of tissue also identified. CELx to for continue capability working And treat already make we’ve the enhanced developing tumor areas intend provide or these achieved these new test multiple ourselves these CELx tests with patients with to breast collaborate technology for of targeted And To facilitate these the Celcuity in efforts Each experience work we we creates differ functional these their sub-groups approvals opportunities developing cancer, assess tests our microenvironment in signaling to new to test other we’re progress analysis signaling advancing types. pathways types our of have

be by breast that step any co-activated we our cancer pharmaceutical from resulting in in clinical or are and as new collaborations results also HERX Foundation to trail therapies trial this This the hoping to Phase drugs, will the evaluate partners to we’re refer stages CELx the Biotechnology’s progressing first signaling collaboration of previously Genentech as Herceptin NSABP collaboration is antibody, least pan-HER, of evaluating hyperactive designed at is HERX Genentech’s We’re and which and discussions to approvals we working patients a trial tumors currently we to signaling in for is the continue with various disclosed. therapy Foundation involve receive collaboration Perjeta test. Bristol-Myers or one Puma Erbitux, a they efficacy of several HERX MP end finalize evaluate by family test, Genentech's and we metastatic or with HERX-negative IRB trial trails in Institutional function c-Met previously pharmaceutical disclosed study fielding hyperactive is current our in of company of continuing expect NSABP at clinical are to our review patients can whether we’re clinical proceeding as and selected It’s trial, and a two as interim we company FACT and the mid Nerlynx, a our And inhibitor, clinical tumors. The efficacy progress. CELx and in board II of is signaling cancer HER X This Puma sites Squibb’s, the XXXX. year. clinical patients. EGFR expect Herceptin, fielding colorectal

that to signaling responsive can For status us a sent trial HERX therapy. Puma compare this patient's with Celcuity the [indiscernible] patient's so

and over excited financial our like progress quarter we’re results. during who would give made Vicky, the we to about you overall turn So now will to the it

Vicky Hahne

Brian. you, Thank

first loss $X.X compared loss million, $X.XX Our of also $X.X same release for for share compared months or to $X.XX quarter year-to-date million XXXX. was $X.XX net to stock-based second share second per net period quarter in include we quarter non-cash in this $X.X expense, share, interest and net included and our per the items, or adjusted quarter. per Because for or $X.X million the year XXXX. press share non-GAAP for the the or loss losses loss was per non-cash significant compensation six $X.XX net the of Net

R&D per adjusted second adjusted share XXXX. share approximately non-GAAP or non-GAAP of XXXX, The Our was the quarter second per to of $X.X XXXX our million or of a six expenses to the million during $X.X loss development compared from quarter of months perform. million net related primarily for loss net of million in for first of $X.XX support six first increase the expenses $X.X months $X.XX compared $X.X in XXXX to resulted CELx increase the compensation

business increased the $X.X The addition, R&D $X.X support expenses due studies, million activities. expenses operational expenses. validation approximate half of first director laboratory increase development to with resulted professional primarily first $X.X XXXX insurance. during in expenses the $X.X in Other In million due perform other to to clinical million associated CELx increased and a million half public and G&A officer and supplies to G&A compared company from increase being fees of compensation XXXX the related and

improvements We $XXX,XXX moves we the leasehold dollars move, in new was spent our this which also for funded facility our during completed with by landlord. approximately second $XX,XXX conjunction the In of quarter.

We also spent the investment. $XX.X approximately equipment. $XXX,XXX equivalents with of ended capital cash in cash, and We quarter million additional approximately

Brian Sullivan

Operator, you, would Thank now we Vicky. like to questions. take

Operator

And we Please Craig-Hallum our go Capital. Instructions] from question Per ahead. from Ostlund first [Operator take go and will ahead

line open. Your is

Per Ostlund

and is basically Thanks, Vicky. everything It on really like here. plan progressing good sounds Brain afternoon,

seeing enrollment. fact the questions on the you prepared quick in of as a I trial, – but Brian site assume this sites NSABP in the any pace of with just that remain alluded they're Just one that I to remarks, me just with the surprises are curious ask related the you're for to you're that. utilizing you pleased coming you I your of update that X. sites internal quality then enrolling to and that that And there the couple guess again and related instead on. confirm the that would are their that to IRBs

Brian Sullivan

can that. to question, yes, your of I So, In confirm part yes. response the first

haven’t expectations not the far as – fail to had IRBs like go [indiscernible] good surprises through, prove a that. anything to IRB that IRBs but are thing So people have – not the or or the process as fail surprises to No these sites. we

site So, either. on our no surprises

Per Ostlund

where last prepared Related well. or somebody test? this side? the remarks on that Or and HER partners do Excellent, premium you're somebody partner c-Met put test between evaluating like When is again as signaling. the and potential with collaborate you pharma room you pharma on There you c-Met to on side HER a excellent, a announced completed there that's there to family interplay, got that to your in and with therapies with that, okay. collaborate alluded the and is interplay c-Met partners call the with is on partners or trying test to the both multiple

Brian Sullivan

inhibitor there's So a of drug number pursue. can I both variations that we that There and for are of a c-Met inhibitor. has companies a pan-HER think a lot

some and number of pan-HER no straightforward inhibitors c-Met pan-HER a have that’s inhibitor c-Met companies a but collaboration, So inhibitor companies that are inhibitors. a and without that have there

ways companies and logical to – we've number thinking fairly that it So thinking initiated companies. through strategies we we're of pharmaceutical and those of about that’s the how discussions don't with different both a have pair

a companies our we've saying have from So think with agent. perspective on that path only single this. to that add I as there's working a working with goals and path been It’s companies a and consistent

patients. as are signal any found of some be their margin, pan-HER much and differences, to in with mean that on able beneficial you drugs activity c-Met would pretty might but be agnostic. combination these We’re inhibitors. to similar we fairly efficacious And this believe I inhibitors we identify any inhibitor the

pursuing so as we're we're partnerships to able really with as And together. companies drug many put

Per Ostlund

sense. makes That

a and ultimately the have the say of that at out eventually that gate test As I together, on situation end cancer you're is you're And putting the type? – all there does depending tests you test, test as endeavor could then to Or all, the become we're signal looking offering be want to the is multi-pathway multi-pathway it sort the you thinking customer? of so don't situation about c-Met – product, each to have standalone where test into be a the on but it test. of out be roll that right together the function do multitude HERX single to you

Brian Sullivan

HERX, fully disease or our test and but become rebranded for candidates be of HERX are pathway each pathways gets potential executed, we plan our We've patients companion latter. that corresponding would and a as these our would drivers. the CELx become that at the candidates again be specimen therapeutic. analyze – potentially the HERX, if that and matching So c-Mat goal diagnostics received plan essentially the our to would But believe them to test Multi-Path we important those as for tests tests

x combination drugs. are we a on can x a of signaling y. drug in a to be our with turn test drug and the reports paired allow so would based and that or or And physician that diagnosis prescribed in or test generate turn drug dysfunction y a That that diagnosis out would result

the would And so and be ultimately for based our full on panel patients best evaluation. then analysis treatment is make what test the to we a think deploy best allow that physicians a And to pathway do way decision. to

Per Ostlund

makes in HSF or you've the about tests, being That follow up that, $X,XXX spoken on Maybe when sense. vacuum type just so the of in individual plus past like the again a to c-Met a potentially test.

Brian Sullivan

Right.

Per Ostlund

the multi-pathway become that some evaluating… because of Does multiple you're test

Brian Sullivan

Right.

Per Ostlund

What individually? been pathways might have multiple of dollars thousands of

Brian Sullivan

we think rationale there's Medicine initially is with answer support people a might I I think had $X,XXX in to the list company short they increased A to the higher The became of a $X,XXX. mutations as rather be of significant price to ultimately or closer a test the familiar they’ve and market that launched $X,XXX. think expanded test price $X,XXX assess, of or panel a Foundation when

a rationale analysis. and for over I And the price do that. think test. higher We would that described we certainly more pursue that’s expect we time as charge to would So we've

Per Ostlund

when that Okay clear just If of for able to very both have me sweep any I then If question types those might they're good. but any you curious we One made the on tissue new last will floor. there's tissue be themselves suspect look I or timeline you those actual of – to will when introduced? the and for be the available, types. do either be might a articulate that sort to as

Brian Sullivan

next that's mean general I We working late early we're And year, the towards talked that. timeline. year. still this about in

the and for to in And – other of processes or types, to but tests fairly A we've develop cancer what so learned work number tissue steps it’s package directly developing lot data associated through. of today these applicable to those not a complex the a in involved breast is go pathways.

the of the so And now. right that’s process we’re middle in

Per Ostlund

Okay.

Brian Sullivan

set want we probably we And don't pre-announce to until have of a data.

Per Ostlund

Yeah, total appreciate makes Thanks, that sense. I it. Brian.

Brian Sullivan

Welcome, thanks.

Operator

other no this this time. there are [Operator Instructions] And at it questions appears time, at

Brian Sullivan

call. the care. to months. back forward Take a attending appreciate you interest in thank reporting Well, for I to all your and few look you

Celcuity (CELC) 12 Aug 182018 Q2 Earnings call transcript