CELC - Earnings call transcript Q3 2020

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Operator

Good day, everyone, and welcome to today's Celcuity Release of Third Quarter 2020 Financial Results. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note today's call may be recorded. [Operator Instructions] It is now my pleasure to turn today's program over to Vicky Hahne. ahead. go Please

Vicky Hahne

press Good a us Operator. Web Investors quarter www.celcuity.com. and you release ended found issued thank financial for be financial Thank third can minutes the for afternoon, of ago. a section site, joining quarter a We highlights. today and XX, third the announcing discussion for our our results results XXXX, you, September business everyone, release few of on XXXX press Celcuity's Today's

like remind number release the These are listeners would and comments I understanding that this differ company's financial may for measures. measures current cause implications actual will include statements. other today's and our factors management those are of our and unknown non-GAAP the decisions, results which Actual future begin, forward-looking assessment today statements reports we and used differ we Before to press These refer call, to projected. non-GAAP outlined financial or involve in non-GAAP risks, forecast uncertainties, of filings that by results, to believes for in to forward-looking measures from future. and uncertainties some the materially strategic ongoing events also a make the investors' the SEC. with involve risks statements is and statements. known forward-looking company's Management Such projected and their materially and in of may from core those these operations useful prospects presentation evaluate results performance. or performance the On and

press to CEO. release. Brian measures non-GAAP like Sullivan, today's our the And in to You table I'd can find the measures introduce financial reconciling with that, GAAP

Brian Sullivan

past comments our development trials. joining then I'm on will mechanism everyone. quarter well I'd collaboration that we'll in open discussion tumor follow a able signaling discussions, Thank and quarter. of therapy. results. diagnostic third the our diagnose with Thank that targeted dysregulated patient's CELsignia, projects, afternoon dysregulated this FACT activity, this Xrd allows I like pathway product many disease on you you will for and good as we're you, our clinical a comment to as matching status treatable our X a X cellular generation financial cancers, my platform, us progress of pathways underlying our Vicky, Vicky drives on today. with for identifies to up line signaling Celcuity's in update the focus and us glad and questions. and the particular to has results, and FACT a

is dysregulated new their targeted Our is pharmaceutical help characterize obtain in tests strategy to companies indications signaling identify. CELsignia treat our molecular for Since tests To to complex their continue proprietary companies therapies most too and clinical for patients strategy. cases, create we CELsignia capability execute platform to to of can a advancing our our progress agreements sponsors. our collaboration business strategy make we the leverage with pharmaceutical to

patients time-consuming clinical in stage. until collaboration one the as at from company. is, clinical collaborators therapies contract past received process pharmaceutical Celcuity, of a intent company's approval receive CELsignia expensive the collaborate have our major evaluate and collaborators our number parties of number to to protocols an are between are have our sponsors, described for approval pharmaceutical final pharmaceutical translate previously, the and agreement to referenced Once select. an discussions several because several and the a of us documents actions company an required I clinical earlier the with companies were pharmaceutical tests they involved. This These that approved our their have from and sponsor we previously same trials Over clinical when months, finalize targeted

and several can -- finalized. first For groups review can by then approved steps groups by of must separate agreements months. protocol Each before pharmaceutical collaboration sponsors separately get clinical institutions company trial clinical get take the these within clinical final the the at example, the

expect to several few Fortunately, we patients. collaborations our including late-stage before to close will drug Multipathway over these our with HERX-negative combinations These soon company close we the Test. why Activity is close pharmaceutical to to two patients are metastatic months, steps cancer collaborations one first which selected evaluate or collaborations completing breast next with be year-end. with different study expect we several CELsignia The collaborations, will metastatic

cancer Puma options There new and for a breast therapeutic is patients. Our unmet evaluating are collaborations need HERX-negative breast significant cancer patients. with Genentech for early-stage metastatic

mostly an disease and mechanism these and believe mechanism. is that can patients HERX roughly for CELsignia suggests of these undiagnosed Our to We patients, signaling XX% we tumors. The test untreated tumors late-stage patients, therapy evaluate our soon close hyperactive disease expect them. in many to HERX with to of have targeted collaborations signaling the the those research likely either with benefit hyperactive or will identify XX% c-MET

breast pharmaceutical PIXK ovarian cancer PIXK in signaling Our also evaluate hyperactive and to with discussions companies inhibitors are with progressing. patients

earlier until these don't in discussions signaling, hyperactive an XXXX beyond. or mid expect some or we at Now, time are c-MET collaborations HERX than those with patients those involving so stage to close

able successful, critical For be not a believe pharmaceutical patient country, a reflects expect these clinical would new unique offers therapies. collaboration obtaining investigators most in for CELsignia these and and their companies towards indication potential We're evaluate that unique targeted to evaluate. the undiagnosed identify respect interest for evaluated fuel their the with amongst the step are the the we partner collaborations efficacy otherwise represent excited the very respected about the the in their a we would with populations in market our leaders If for patients. to offers drivers of also with targeted They disease to oncology us thought expands their trials. to to test opportunity Celcuity therapies collaborating researchers the company

to tests. also CELsignia the third During quarter, continued we additional development of activity advance pathway

cancer. tests RAS to this involving is RAS sponsor research all of network led has that percentage identify breast tests CELsignia pathway-driven new Dysregulated cancers and signaling molecular develop nodes a with to significant in responsible many is companies goal which pharmaceutical undetectable Our ovarian area. cancers, for in

for expect report We conference these the in cancer first-half new tests to a of at XXXX. data

also into insights CELsignia the unique RAS the provides of interdependence Our various pathways. platform

inhibits present therapy. RAS referred targeted For therapy a activate turn a and pathway in typically resistance patients, another targeted as one of that at to is efficacy may many RAS the mechanism, pathway, which the can reduce this

these PIXK patient's cells. For tumor can the pathways MEK activate some using signaling instance, vice mTOR it and With analyze inhibition this between generally the patients. a versa understood of is different can and network detrimentally CELsignia, interactions interconnected we or in that

identify and these blockade occurring. prevent be and us resistance longer So survival. to combinations the drug tumor control the The it to can that better overall ultimately would allows benefit patient interactions from mechanisms

the addition, the us relative the of we relative activities. also help superiority investigational efficacy to for our can approved RAS potency will targeted of and This guide enables In therapies which RAS therapies characterize the and assess different nodes. different collaboration targeting pathways,

to Finally, from second-half of X results and interim expect our FACT X FACT XXXX. trials we continue in the

to of delay Although experience reporting delays, further should it not COVID-XX results. some sites continue

to drug in CELsignia significant but our patients treatment concludes adjuvant these in over number HERX-negative of many Pathway are increase anti-HERX in of review is not trial all X goal by a to patients. cancer However, pathological new results. recent for trials receive I'd the response adjuvant next my initial The yet early-stage related play to a to breast new who whether of are turn patients over the months. enrollment to hopeful lives have of cancer the FACT Since activities to cancer than each That as complete in few COVID-XX treatment the States hospitalizations do aware, We're that to response patients. breast FACT our financial will test, obtain complete test Both less and impact know anti-HERX cancer evaluating rate breast CELsignia can pathological recur. we X like drug demonstrate higher now role a Activity therapies. therapies identified current Vicky trials the likely a are it HERX extending remarks, a you

Vicky Hahne

$X.XX quarter million, months losses loss for net the included $X.XX $X.XX net million, the $X.XX these or of per compared we significant stock-based for or per was share, non-GAAP to share, $X.XX nine of for loss also XXXX. release to the quarter quarterly non-cash our compensation, was XXXX. second net net million third or $X.XX Because share, press the share, $X.XX loss, item the first quarter. loss year in in per Net same period per Our include compared or million, $X.XX for adjusted

stock XXXX. of $X.XX Non-GAAP was compensation first loss XXXX, $X.XX months loss compensation. $X.XX net first to for of $X.XX $X.XX nine or adjusted million, Our net $X.XX third million non-cash to nine to for $X.XX of share, $X.XX months or based loss nine to million non-GAAP for non-GAAP the the million first was million, per of of of or of the compared R&D months primarily in XXXX adjusted quarter quarter compared during for $X.X the $X.XX included increased expenses third compared non-GAAP of share, the share, approximately per of XXXX. XXXX, first $X.XX due months increase per per net expense, million, adjusted nine share, loss net which XXXX, million, the adjusted or

approximately million and stock and expenses operational due business compensation first due of million included non-cash nine the increase other validation In XXXX XXXX activities. first primarily compensation. $X.XX $X.XX $X.XX nine the The in months addition, and studies $X.X million months of increase expense, which of research increased development and during was to compared G&A to development to million in laboratory based clinical

with professionals ended prepaid offset $XXX,XXX. was $XXX,XXX In non-cash primarily cash quarter company. in of XXXX of and this activities for increased capital working and in equivalents. of a million $X.XX associated $X.XX expenses net cash accrued million non-GAAP million, the used the to result third loss public a $X.XX of with depreciation administrative The expenses million, of net assets addition, by fees general being other of and expense changes adjusted and operating quarter We due was cash $XX.X --

Brian Sullivan

Vicky. you, thank Great,

with we're So, progress summary, we're pleased making. in the

from and with some to continue excited this clinical to collaborations sponsors companies. very proceed advance, expect discussions and getting pharmaceutical pharmaceutical the year. about close to Our companies approvals we We're

interim results for to second-half the remain cancer of data test we for questions Operator, take from in X X the now. we'll and that like patients expect obtain present XXXX, in CELsignia we'd trials early FACT and XXXX. We to FACT confident breast another

Operator

from [Operator Please like looks is question Chen And our Wainwright. H.C. it your line from Instructions] ahead, first open. is Yi go

Boobalan Pachaiyappan

in for Yi Boobalan you Hi. me Chen. Can is This okay? dialing hear

Brian Sullivan

we yes, Well, can.

Boobalan Pachaiyappan

awesome. Okay,

can how and the FACT study, So, color progress on FACT your other like X is you current and provide additional remarks, in looked started quarter? what prepared than during X

Brian Sullivan

in second-half do in most hard is particular results again, think when progressed our COVID XXXX, the a way significant the kind think, and of clinical that will over that we of think I hit expect there some trial the get that along could the some Well, We announced don't that know of of trial activities, remainder how recently expected, and sites. affect. but in their an I We would kind affect factor unknown of assumed pauses we don't couple We the we of the have a much XXXX. of quarter are itself. been to pausing be it's course as have

Operator

from [Operator Instructions] Alex Nowak from question next our Capital. We'll take Craig-Hallum

open, ahead. Your please line go is

Alex Nowak

afternoon, Good everyone. Great.

in to last the happened to on we and and in early south, When Just there. cases question X? follow-up QX, what saw in enrollment rise FACT that X FACT the

Brian Sullivan

areas know and draw from that the themselves we beds we believe but hospital other that saying mentioning there overstate want trends many have enrollment see, a I'm we ones reports to an or screening that. know constrains don't results because sites -- to and feedback been with down we're past not and we've seeing second-half only essentially of so distribution sites limitations anecdotal because a or it the in just giving activities, that happens you to I'm over of just activities We are of kind that's of in standpoint general, report information that has but talking sites. we're anecdotal that -- have and on week I'm too having We not slowed that more received. NSABP some that necessarily from, patients of the when been couple XXXX. their did can activity track different that some still but I number

guess not providing I or I'm attempting So change trying to only outlook. color our but

Alex Nowak

Yes. others. No, seeing obviously absolutely, is right Brian, is impact a and now, Minnesota big Wisconsin, so and

patients primarily the to to what we second-half to I continues won't maybe or going are next So guess the I guess out that the have early kind you the of be with feeling QX right were would over where you where couple you're confident of have enrolled number. where going you'd pretty here pretty readouts," of QX say, are of enrollments with "All all of the just signaling pretty enrollment through point now what that perhaps you number weeks, second-half heading QX, were be as of get through right, you in looking but been all happy, XXXX for. confident versus have enrollments be able

Brian Sullivan

we'd forecasts Right, the again, confident I forecast now. I yellow, it. thought don't the for we grade or supposed green, mean, report as of but to keep the had if data, red, we're

but patients the the that would been can't, still so we we projected only get, report about second-half. on to we'll date I change opinion in that can get about we I have So patients there's our that. what's mean going the and that

Alex Nowak

understand, Yes, make I the tracking they line, case things okay, things, and sounds we're even you like sure but certainly are. to are in want with latest it spikes, still still

So want I to that. just confirm

that be Phase the be was should bit? the and months collaboration Would FACT-X metastatic, of stage the FACT-X these enrollment next enrollment is say was early condensed cancer, studies, to X expect the it similar would sign because the fair is longer, be and just FACT-X is here. fact few to for a it with time that pieces So good. to you FACT-X one that's, that's these and know The I in

Brian Sullivan

options, there and to think of mean, them, on because prognosis better stage much if the a a these find so that but think clinicians greater patients, there they going two would prior are so, more they and metastatic to patients community, will failed fewer ability have cases things we one, but patients, have where fewer we they're alternatives. you patients, more are I I they urgent early got have have have they therapies the have overall, fewer much need patient alternatives, engage in know their a have to, metastatic

entirely it's an different So, dynamic.

because own before. of be c-Met, different case in In will or X, been cases, Now, several each evaluating drugs we're populations. but of trials of its two has trial some that HERX Phase these they're the addressing tried most characteristics, them haven't

very are but to so patients, overlaps, do dosing, you XX that be a not and just small, a small study might it Phase So XX patients, small confirm toxicity setting in is you're several that a for Xb got the that's there but no that's relatively getting selection, their really failed Doctors safety find case, therapy, data others, and an you've for to higher. to participate of motivation have maybe so option them motivation lines patients where just and

that ahead again time, different each could timeline have So, have get get my to of trials, net-net, will trials are when think a to we because estimate story own we and different number the tell. the will at the skis, data we but timelines, we its of don't announced there want I characteristics,

Alex Nowak

I I collaborations separate breast just metastatic and on HERX confirm, absolutely. no, I two breast want the sure to cancer, negative for to just that, the mutation? correct make and was two this cancer, Yes, number is understand

Brian Sullivan

isn't process would among different are kind of the through to drug intent us and There a no, combinations, their different steps concept, a collaborate to final documents approve it's a and than other takes a the be formal approve way of basis, done, provide is just gives high the getting of the having of matter regulatory it's is path the go that encouraging like, longer along confidence protocol, two sign so, to and desks. degree now certain which matter but the companies documentation move a just again, from on drug drug to I'd obviously that, receiving for you getting, approve

Alex Nowak

that do yes, targeting? XX% the just you molecular question just there's Yes, patients you're new particular, that that. this more clarification, for indication more specific XX% say this be because cancers to roughly absolutely. metastatic one or one then able for have would would missed identify of One test marker the after In

Brian Sullivan

Okay, you the tests, so add c-Met, if HERX, HERX up three [indiscernible].

subgroups, aggregate and use but roughly to to round would patient is XX% closer the was say say you it's XX%, are leads than that. I these patient patient a probably it number, smaller to just we round number, If if a to and groups individual or XX%, groups

have there be be that different HERX we'll combination will will for that So an indication drugs. that studying

that with separate with, inhibitors, on proportion of an north and that or less patients a certain pan-HER XX% with combinations we're but different as that working example. they're drug drugs several combined c-Met of inhibitors will to will trials trials XX%, be different separate evaluate have than So,

Alex Nowak

question got an for with regards you to and you? it, is Okay, opportunity them? here, Roche and still area how then additional Genentech having just collaborations conversations with are and Puma last Or just with of this

Brian Sullivan

I a ongoing names, has to have time. both with again, announce Well, we're could HERX having with don't with until their think very Roche hope pan-HER don't I characteristics, they mean, we has, I and close to the drugs, Puma so good I to collaborate but I like that, different in say announce we're over both, inhibitor. to want and touch them, conversations

Alex Nowak

it. you. That's Appreciate great, helpful. Thank very

Brian Sullivan

welcome. you. You're Thank

Operator

we another like Yi looks from It have Chen question H.C. from Wainwright.

open. Please go ahead. is Your line

Boobalan Pachaiyappan

one Hi, is this incorporating for me, really Pachaiyappan. quick. Thanks Boobalan just only

you expect So next rough XX do have finalize like how to many six number? within you do collaborations the to ballpark months,

Brian Sullivan

three say five. to I would

Boobalan Pachaiyappan

Okay.

Brian Sullivan

two. than More

Boobalan Pachaiyappan

Thank you so much. Okay.

Brian Sullivan

You're welcome.

Operator

program I'll appears turn speakers additional It [Operator further or any for the closing over our that at time. this now to questions Instructions] remarks. we have back no

Brian Sullivan

interest your months. with Take Celcuity, appreciate to again in attending look speaking in everyone care. the you forward few We you Thank for a I call. and

Operator

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

time. any at disconnect may You

Celcuity (CELC) 9 Nov 202020 Q3 Earnings call transcript