- Earnings call transcript Q3 2022

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Operator

Good day and welcome to the Celcuity Third Quarter 2022 Financial Results Conference Call. [Operator Instructions] I will now turn the conference over to your host, Robert Uhl with ICR Westwicke. Mr. Uhl, you may begin.

Robert Uhl

Thank you, operator. welcome update third webcast and results XXXX everyone, business and and afternoon, to quarter Celcuity's financial Good conference call. Inc. Celcuity today, Earlier released third the financial September results XXXX. XXth, quarter ending for the release Investors be press The found section the website. can of on

Q&A. are Medical Joining Sullivan, Executive be Officer, Hahne, Financial who Celcuity's Vicky as well during Brian Officer; me will Co-Founder; call as and Igor Chief the Chief on today Officer Gorbatchevsky, available Chief

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

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

Brian Sullivan

quarter, cancer joining I'm inhibitor. that of CDKX/X and is combination VIKTORIA-X, that the of Good advancing with evaluating treatment VIKTORIA-X has thank investigational an breast to Thank third the our progress a efficacy an significant HR-positive/HERX-negative pan-PIXK/mTOR you progressed product inhibitor everyone, report you, in drug X Phase trial. our us the afternoon, aromatase treatment and clinical today. inhibitor for we for advanced made pleased after safety lead in candidate, gedatolisib, with Robert.

site our in participating researchers XXX the this were principal breast America. America, to world's in The cancer that team very of third study. this approximately objectives trial is registrational objective the next respected the completing clinical with so each sites North We we operational was from patients. Asia, regulatory significant Europe, completion sites participate activities received objective for will selected and the located Celcuity selected at in the that interest clinical of sites by working for process, investigators study. selection key One assure now trial and in planned. Australia our we this our the Many begin is and of achieved activate world quarter the we the most selected clinical and sites, across encouraged are sites participating. critical enrolling can Latin site selection of closely to as Throughout

to track in activation site quarter, regions. our achieve and goals on first we was activated all third are across Our the site

for half with non-mutated we and the the the be also administering continue for dosed to available patients of second first to available of data our We mutated XXXX on XXXX. track by of the to and the remain in PIKXCA first prior PIKXCA of end year, the the in be half expect patient guidance patients data

review represents profile. a a study relevant population We Gedatolisib received such as for for only and from at an the therapies Spotlight estimate XXXX. progression-free the target inhibitor, designation XXXX offer therapies the to specific Poster that during FDA These these a annual to included off results patient study targeted of cancer third time with at gedatolisib dosing Track patients endocrine therapy. and Breast Antonio As XXX,XXX study. an basis. received breast designation Discussion include was very over modest from previously this the case the challenging Current met. intensive using the quarter, or our alpha patients, the Xb granted breast periods a advanced criteria Spotlight schedule we on, designation approved and our fulvestrant Cancer mTOR fulvestrant in third-line if abstract was cohort This the data quarter, from last survival of from for in from Discussion weeks regimens FDA for have accelerated week breakthrough potentially previously more accepted of reported, on the who updates January cancer. HR-positive/HERX-negative we're therapy second Fast patients X standard advanced Preliminary this that PIXK and the PIXK cancer treatment allows U.S. alpha-specific potential are care breast Phase and the during FDA presented data presentation an globally San that combine safety in initial Symposium year X guidance Phase Also with Poster X December. in of

also historical X to this an For response of Only the care of [XX%], this controls Compelling X% rate from median or patients safety the was discontinued patient the and months. for was results cohort. very period progression-free objective reported treatment data compare in favorably total, therapies. current adverse event. These XX.X was survival cohort, to standard due

of due hyperglycemia patients treatment In and or patients X no grade X% grade discontinued reported hyperglycemia. X to only addition,

identifies cellular driving matching a be Now to move CELsignia, may pathway tumor, dysregulated diagnostic underlying diagnostic on that signaling patient's be business. identified. so our can therapy to that a I'd like side targeted the activity platform, third-generation of Celcuity's the

that is enable a of receive companion number strategy pharmaceutical to diagnostics eligible therapy. develop to to the targeted their combine expand company Our to patients

pharmaceutical Board years XX Murphy she’ll HR-positive/HERX-negative Directors. Pfizer. companies, our broad of interim leading expect patients cancer Dr. at from positions our of of in early-stage results Board. business experience has XX with CELsignia years And like for in to FACT-X responsibility and to over at FACT-X I'd the trials having to looking welcome the increasing finally, We bring to forward development mid-'XX. Polly platform including breast and We're industry global commercialization perspective experience Polly

Now I'd call financial turn Hahne, CFO, over review to our the our like results. Vicky to to

Vicky Hahne

everyone. the today a good you, and of brief I Thank I'll our will more overview invite for which of afternoon, for and detailed provide quarter review XXXX, Brian, financial filed third be you results to the a discussion. later XX-Q,

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

and share warrant loss quarterly non-GAAP per share XXth, of additional XXXX. interest, non-cash also share, modification. our to $X.XX include net press including For release stock-based deemed we included items, significant these net Because an purposes an compensation per included net loss of per from ending adjusted calculating loss loss for $X.X resulting related in net the million the September approximately a reported losses $X.XX quarter dividend

net and Our of for compared the R&D net of pivotal during to driven quarter adjusted activities non-GAAP I XXXX third $X primarily of XXXX. non-GAAP the million The in million hand changes The $X.X for operating cash and the to the approximately XXXX the now XXXX. and $X.X cash of $X.X administrative of of million the to $X.X compared was was million, working $X.X capital compared for was XXXX. non-cash the XXXX loss VIKTORIA-X same non-GAAP $X.X XXst, quarter Net and million. $X.XX will $X stock-based increase for $X.X trial. We quarter compared call $X loss cash to adjusted loss used third for third share the third was expenses $X.X in per with of equivalents related of million to third $X.X on compensation. million of million or $XX.X quarter offset primarily million period XXXX result a expenses for cash from approximately million of increase XXXX This $X.X of per of quarter million million was million quarter million net of million $X.X the driven December quarter and quarter the to for equivalents for remaining approximately share third ended million of XXXX. the third approximately of supporting the expense third employee by $XX.X cash the related and depreciation XXXX. General activities increase were quarter million adjusted to expenses Brian. $X.XX $X.X were of of to by or compared

Brian Sullivan

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

Operator

come Maury from [Operator first Jefferies. with Raycroft question Instructions] today And will our

Maurice Raycroft

and progress, thanks questions. X my the on for got questions. I've Congrats taking

talk sites XXX about said XXX of why need if you the sites reasons mentioning about [run would prior, study only worldwide you'll if XXX today, that Can XXX So in sites the at maybe XX selected or all and have you from XXX run clarify about at] would you sites. you the study you're still update, need countries, you've XXX? the selected for and be

Brian Sullivan

When first announced that we sites. I do would we study think the we indicated design, XXX-plus

we that qualified but of And so generally of you because sites, sites we interest it with more the they'll just will, have get if at to XXX them, estimated we're that that that. we and we, do we wanted And sites able a wanted minimum, get more broader available. enrollment the reflects in And be benefits we think population enrollment the effect, the had. enhance significant active Company to

Maurice Raycroft

Or it actually could it make potentially -- accelerate lines Do What the more sense. could That some? it thoughts makes are enrollment robust? you time does on that? your think

Brian Sullivan

probability It's would want our sites it guidance. to meeting don't more change of enrollment having think certainly target. We an of that way. I increases the

Maurice Raycroft

And other then one question.

whether could And this order have dose end to if patient needs provide year. that activated your first at on specifics you first of on enrolled can patients what in by at comment be site, wondering you Just point? been the completed to some the

Igor Gorbatchevsky

first we patient haven't Well, enrolled Sure. our yet.

must steps are formal selecting we our of a one study. initiate just we required so And And site. In sites, of Committee then study which Independent be Ethics the process. a is regulatory, a central to financial, an participate the once also Once is first must activities required. And some activated approval your is variety IRB. cases, selected trial, a or you've first site or approved by in from be approved, operational Scientific Committee documentation certain institutional

patient population. before considered And active. working -- with then So to can completed begin have be they their site active, a once be is a site all a these study steps

their available. has of with These occurs very patient time, period necessarily as an immediately treatment time. a predictable over typically and sites, inhibitor Our CDKX/X extended a activate get are patients treatment that's more aren't over and into that pattern. you of population enrollment But it a first-line duration you

Operator

take from from we'll question Peaker Boris our And Cowen. next

Boris Peaker

One and the assay. trial questions. have the VIKTORIA the I CELsignia X on on one other

is study the curious, EMA? I'm would approval as trial, -- the just Europe for VIKTORIA with you it just what serve the want well? have basis On know I in discussed successful, a trial to as if design

Igor Gorbatchevsky

gedatolisib discussed Yes. from saw And on feedback scientific their but F, study, we made PIKXCA that EMA. second that input We wild-type And patients, us mutated process. the have mirror it specifically have formal essentially, quarter, recommendation They X the is advice in decision patients. for received essentially we plus based we study arm to end a Arm fulvestrant. May. to And for of PIKXCA which feedback, for at get the add to an was their the or study

Boris Peaker

on FACT-X and show approved? assay to of get set need the order you in And can studies to the what CELsignia, the expectation FACT-X

Brian Sullivan

in to with is Sure. is controls. that study The will show historical superior patient our demonstrate population the to rate response that pathological CELsignia be identifying objective to the or that treatment complete study of

the target treatment And is care of historically setting chemotherapy. positive HERX-negative/HR who neoadjuvant for of these PCR have so -- XX%. around population, early-stage HERX-positive/HR rate in are patients Standard the a

assumption historical or so can And through that our control. is is superiority hypothesis that we the that demonstrate

Boris Peaker

may there the But with FDA of wants Or just... it agency? metric you see be that is that specific is a kind the to discussed any

Brian Sullivan

complete the response Pathologic is endpoint.

Operator

go we'll next with to & And Needham Gil Company. Blum

Unidentified Analyst

the want if in This Gil. guidance? are is for to cash commercial start And included cost the just [Chan] preparations? of ask when planning to the preparations We commercial are you

Brian Sullivan

at more are to variety obviously, holistically evolution, take. variety The we're different the stage, go approach could that There commercial preparations of approaches want an different options, that we assessing taken. this through be a of a

evaluation. that begin we So

intensive more would XX XX to months prior months expected approval. the think I begin expenditures to

those of And we and we back expect time, would So off included the period in of those that. expenses from as flow. cash some we're of expenses see to to closer a ways that, are get some ramp in the

Operator

Instructions] next with Alex we'll [Operator take And question our from Nowak Craig-Hallum.

Connor Stevenson

X for on VIKTORIA. CELsignia on Connor first, is Alex. This couple guess, I a and on or X then

sounds FACT-X good. trends of has as mid-XXXX, COVID and that reading FACT-X trials of speak mean just what you there? I part potential all and second those enrollment of what's about And Can then just kind interim mean, to CELsignia, out on First mean, X? time still they into -- trials, where I the X And FACT I stand? that question, do here? abated lines X, kind

Brian Sullivan

Sure. so And on to or seems the for back that adjusted FACT-X gotten healthcare enrollment remains has that it. to that's systems -- same the interim why at Those COVID regarding and track FACT-X, have guidance analysis. least have our now abated

the other as are metastatic were was far set Those As studies, just coming as in setting. FACT up those a to COVID fore.

got basically would you so imagine. significantly affected And as that, by those

And 'XX, to early 'XX. later so data expected in those have be would interim potentially

Connor Stevenson

in I you so activation maybe, the you geographies. anything into with can of point, and second then Latin cadence and And kind move Yes. is on Europe guess, And at do offer there VIKTORIA, to point QX? the comfortable you on to maybe the then site first site Asia and us of far America activated, with can the what sites U.S. feel where other the

Brian Sullivan

Sure. all are world simultaneously, activities all different countries requirements. those Well, -- and occurring across the different have the

just The country. as by lines vary country those of requirements. differences well in varies some will of time because process the So by

-- And we've all sites all we're a proceeding those so pace across countries the for selected. the

that take financial the It's process operational doesn't each approve hospitals expect the prepared larger in institutional Ethics to something site required that and be or or has immediately. approve institutions, approved, Committees to multiple outlined complete. I Ethic will a to process central and an documentation months needs We that's where IRB, particularly Independent to either Scientific cases, -- get some need to Committees Committee. to IRB study happen

have And each time line all a our So sites. those we for into fore. come factors identified of

have enrollment activation those incorporates We projections. our projections a projection into site that

we've will site on And so that and initially the follow. our activation with what track for projected enrollment we're

Connor Stevenson

expected Maybe Maybe -- and more patient just to the level I be off December just XXst. placement speak XXst. speak needs patient to you first could by being if be of get one patient I dosed squeeze mean, that, indeed year-end that can December there a confidence with private based dosed in. kind by of dosed the to by first your the to

Brian Sullivan

that. No, we're We're very That's -- and the really confident. that's good kind plan. sites, of activating very about feel

Operator

for turn to at back I'd there this like closing Instructions] And any remarks. further are or additional no questions [Operator call time. to the Brian Sullivan

Brian Sullivan

our few Thank up We Goodbye. you call. you, for attending your appreciate forward and interest look months. everyone, to with catching over next the

Operator

attending. And this for concludes today's Thank conference call. you

Celcuity (CELC) 13 Nov 222022 Q3 Earnings call transcript