Earnings call transcript Q1 2023

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Operator

Greetings and welcome to Celcuity First Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Robert Uhl with ICR Westwicke. ahead. go Please

Robert Uhl

Celcuity and release Thank operator first to on Investors XXst, the Earlier everyone XXXX first of for Thank ending section be quarter for good found joining call. March today, update. business you results The Celcuity's financial us the results financial the press you, XXXX. and afternoon released can to website. quarter the review on

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

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

other from Actual projected risks, and implications events projected. involve those known forward-looking materially actual from to in those differ the and that differ results unknown statements may statements. Such results or their factors or and performance may cause materially forward-looking uncertainties,

evaluate non-GAAP company's we make decisions, to used and also future refer by These strategic measures. this call, results, measures On management non-GAAP performance. will to current financial forecast are the

non-GAAP these and investors' company's ongoing of prospects presentation measures assessment core for the of believes is useful for operations financial and Management understanding the the future.

to in today's measures GAAP press find can measures the table the financial You non-GAAP reconciling release.

the Brian I call And CEO to like Celcuity. turn over ahead with that, sir. Please would to now of Sullivan, go

Brian Sullivan

XXXX today. I'll make you, a full weeks we during corporate call, provided Robert update only everyone. year seven and remarks ago Since prepared Thank just our brief afternoon good financial

sites. enrollment our to our Phase I'm VIKTORIA-X very X trial clinical of activities trial date with execution pleased at the

inhibitor. gedatolisib As advanced CDKX/X with we've without while reported in cancer, palbociclib, VIKTORIA-X with adults and receiving breast whose HR+/HERX- a evaluating progressed in combination disease fulvestrant is with previously,

subgroup in analysis patient the Our in to PIKXCA report XXXX. team guidance. primary track subgroup of keeping analysis the half of with for consistent the the XXXX is focused on and second PIKXCA-mutated the first for primary is in patient relentlessly prior This our half non-mutated us the

Cancer breast positive Congress We updated data patients. an presented data think survival advanced HR HERX for very the Breast last week, ESMO cancer treatment-naive median encouraging. the At we progression-free is

our expansion are efficacy safety arm we Xb presentation, In poster A and arm in provided and study. our data of patients in updated A treatment-naive escalation enrolled who Phase

the has PFS date XXth, We last have previously group not San RNA data Symposium June reported of at and been Breast expansion of reached. yet for median the but cutoff Cancer this patients Antonio XXXX,

XXth, report additional As response data XXXX median with the of were the March for benefit data final able we period, to median and duration the survival cutoff patients. progression-free date, of these follow-up of

and was XX.X months for from of treatment-naive progression-free duration For and arm months. was median results XX.X RNA, these A, and survival analyzed XX.X of it months. are escalation patients and median was median treatment-naive months progression-free XX.X patients each together, survival arms the response expansion was When patients for

the PALOMA-X highlight in a positive HR These as in for intrinsic think breast results the to reported driver the first-line these study This a HERX-negative pathway XX.X as PIXK/mTOR data cancer. demonstrate very potential gedatolisib advanced treatment results the to letrozole. PFS favorably of palbociclib plays median compare develop opportunity also disease months We role the option.

activity gedatolisib class. characterize the drugs compare and its other various to activity to We tumor in continue types in

for AACR in presented we cancer, April and non-clinical As gynecological we for other previously GU gedatolisib's studies the ASCO differentiation February from highlighted cancers, this at in class. drugs reported, prostate in at

therapeutic assessed, mTOR effect demonstrates AKT, the inhibitors all the superior of the gedatolisib types In and studies evaluated. other each and of to we relative performed tumor PIXK,

with results well types. We'll the as internal is tumor develop prior these drugs in these think a in on priorities from significant provide we results as update this to for studies, non-clinical opportunity gedatolisib reports class, us year. on this an Based clinical our published later there development of clinical

trials HR HERX and pathway enroll positive first test. FACT-X results XXXX. patients continuing the cancer. are in our as studies These early-stage We expect breast with to FACT-X HERX-negative to is with of these detected now from half announce finally, interim And CELsignia hyperactive the

I'll Hahne Vicky over financial now And to with that, results. review turn our call to the

Vicky Hahne

quarter and everyone. good I'll afternoon of XXXX you, a first Brian results. overview provide brief Thank our financial

expense, per quarter loss compared a first million $XX.X or net of Because per losses or loss the net net adjusted for was to share quarter stock-based non-cash including loss our $X.XX quarter ending in include first items, quarterly of we share the include XXXX. press The these XXXX. XXst, net for March loss million $X.XX interest significant loss $X.X also non-GAAP compensation and release

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

XXXX. cost $XX.X development and were to VIKTORIA-X pivotal the first compared $X.X of related for supporting Research to million activities quarter the first approximately the million for The of million resulted increase quarter $X.X XXXX expenses trial. primarily from

General of fees and the of professional million was a compensation public of increase The being non-cash, with company. million quarter for result associated approximately stock-based administrative a and first expenses XXXX, for to the first compared $X.X $X.X $X.X were quarter XXXX. million

$X.X cash $X.X quarter non-GAAP result million interest adjusted cash, investments compared capital XXXX. a and Net working activities first in used of was loss income short-term equivalents XXst, XXXX. the approximately $XX.X the of for changes net cash of quarter We at XXXX to with December $XXX.X million million quarter million million. ended $XXX.X approximately million, of for of of million, This to operating compared first $XX.X approximately $X was non-cash the and of

now call the that, hand I to back will With Brian.

Brian Sullivan

Operator, could the please Vicky. for call you, open questions? Thank you

Operator

Sure.

now a session. We conducting be will question-and-answer Instructions] [Operator

from question comes Please go first Our with Jefferies. Maury Raycroft ahead.

Maurice Raycroft

your that taking relates for and you AACR data questions. at I breast PFS to be steps those later the what my what And inform data, year. Phase talk on and factors the decisions? would presented progress? frontline into it gating development based cancer guess, and as ASCO wondering, it next can GU the data the thanks you the go on positive ESMO would Hi. I more preclinical was progress with are Congrats X to about this

Brian Sullivan

So, we've to somewhat landscape consider the of development evaluating gedatolisib. opportunities been independently of for

data, in parallel, ASCO helps presented for And that the inform has and the job great our at studies AACR, data of and developing so we decisions. R&D done a group reporting, the conducting that

class. other And holistic market differentiation, the and has opportunity, prior all also we've its characteristics that analysis -- as to essentially unmet as then prioritize. of doing areas. of the us standard-of-care led gedatolisib develop well needs indicator we've doing would clinical conclusions a data of evaluating or results both evaluated in need, about trials published treatment, some we prior for Simultaneously, unmet a been in how review this the inhibitors And

expect few what and say, to by in decision And I the than essentially no for went would development next why prioritize we'll QX. We announce the us next into at later months, step clear make that. our we point, in that

study. first-line our And very we'd our essentially a that get through respect hold With significant study, breast for be very have say a long purposes to second probably we line would until off to study. would practical it's obviously one that we cancer,

for to what kind interesting if to trying long-term data of, is compelling investors and certainly still the the and very, consider think potential they're company the We for is. important evaluate

the breast data this possible. who most are at in as ESMO direction, capable progression-free benefit of where suggest for the And survival for for early certainly we and metastatic with potentially, period treatment-naive goal diagnosed think points have that could providing significantly cancer. I a that drug developers; patients the ultimately presented enhance updated as is to newly the we drug us that's data patients

for a long-term, think of significant So longer opportunity group help to represent periods would time. a we bigger of patients that

Maurice Raycroft

maybe makes other how All Phase conventional the question just statistical In analyses X. X. the Got on it. are Phase the for mentioned you've one And the and past, powering sense.

how more point specifics regulatory the half factor statistical three providing be at Are path something those later for on learn XXXX about that that Or the before assumptions into forward? you could second any primary endpoint analyses, would readout? powering the a we and more

Brian Sullivan

has fiscal the the by through part and Well, year process as last analysis been reviewed of we we FDA. folks. That was went plan the to described

primary we use, So, that accessed we've proposed the approach, analysis that's all been our by essentially added and the FDA.

would primary numbers conservative being of XX%. side used -- a to the sample err have I would the determining expectation certainly mean, think When I typically XX% typical. you north talk think about is have We we higher powering, on and for you probably the analysis. I power conventional size and of effects is say, analysis, for And primary that the do more more

of And on analysis. typically then X.XXX is the alpha for side standard, -- certainly, fairly one

And a consideration. that. not types to are be any on And But presenting think think, appropriate breaking shouldn't they're the typically, those present so data. more of we we're trail when details of investors I

Maurice Raycroft

Got it.

Okay, that’s hop in helpful. taking for questions. Thanks queue. I'll back my

Brian Sullivan

you. Thank welcome. You're

Operator

Cowen comes go with Boris from Next Peaker question Please Company. & ahead.

Nicholas Lorusso

question. for Boris. taking for Hey, is This thanks our Nick on

a quick So, just on question CELsignia.

delays? data the same XXXX. because they've also date So, I them first note pushed slightly has this -- half in I if in been potential back is that was FACT anticipate the some the having for if other these of you wondering delayed of the that was it of if trials, for the been

Brian Sullivan

the say greater projections in had and project I the with results to I be to would think with we and patients samples requires able slightly in biopsy and off. were assumptions prescreen get screen it -- longer screening just general, or we certain patients the pool enroll. those a the of Yes, essentially get to stop-start enrollment to have we And ability additional samples, pandemic, to a to used

conditions for comers. other to essentially is prior all women enroll. different of a that face CDKX/X meet trials progressed and We're from criteria the who again, able CELsignia enrolling are VIKTORIA-X, are instance. on eligibility wholly equivalent who And VIKTORIA-X

XX%, no have is a research patients biopsy the are patients, screening There's with then of hyperactive sound HERX have significant signaling only required, where roughly XX% to CELsignia case out eligible. a and who which

conventional So, to project rate just process a and a slower in VIKTORIA-X. activity more two-step overall the also of harder like trial activity you is have that than for would results

Nicholas Lorusso

for detail. Thanks that Understood.

guidance or just one. have as any that? like quick you ended what anything you with was up or to know cash another cash, had cash the Just runway if guys burn I wondering I

Brian Sullivan

previously guidance end guidance. would We've we sticking this through and of us with XXXX, that cash are the our provided take

Nicholas Lorusso

very you Thank Great. much.

Brian Sullivan

welcome. You're

Operator

Next & go Needham question ahead. comes Bhasin from Rohit with Company. Please

Rohit Bhasin

this Thanks Can Thanks. can you anything my studies? tell for in enrolled many you questions. tell And plans? ex-US and been is is about FACT-X Rohit us the taking us there have for FACT-X how Hi, patients secondly, on Gil. then your

Brian Sullivan

we're basically, done. And So, guidance we we studies. analysis providing haven't provided in on to enrollment activities interim be that on updates when those expect

And that as more I as a referring development guess, you maybe detail activities, far ex-US, question? activities, on little could are you provide commercial to

Rohit Bhasin

commercial you can would Thanks. if and just talk about your preparation be activities, great? Yes, that

Brian Sullivan

is soon as sure are Well, now primary study Sure. conducting practically possible. our and as getting our focus efforts data making the the

As a far mean, somewhat commercialize parallel as the be commercial able efforts, of to in well-understood path you prepare certainly NDA. to to preparation I that there's your

are those US say in would. the on for we a to process. would activities when in -- we're activities you I what would company track are expecting expect early commercialize with The

to some As far publicly most to really plans position, our I form biotechs the any in of are. haven't our described But would for would detail they say partnering in drug look ex-US. as we commercialize ex-US, what

haven't that to And we any area. made commitments

I finalize Or take path anything take. to that path others will on I to in premature a that trail, area. for finding for to have markets. us very it entire taking think, I But taken, partners us breaking ex-US certainly is doubt the different it's think be plausible

Rohit Bhasin

Great. you. Thank

Operator

comes Nowak Next ahead. Capital Alex go Craig-Hallum Group. question Please from with

Alex Nowak

the are In or the the adverse study everyone. kind Hey or were part due versus unreported of prior events afternoon the great. of ESMO the that data, any rates up, previously cut latest higher maybe to there Good the data cuts? any toxicities that of just or popped final

Brian Sullivan

question. great a that's No,

no. out, turns it As

So, -- and that December. has updated relative to data in been we the data presented

any that presented really in wasn't change as as there presented at ESMO San So, at -- data Antonio. rather

we toxicity the continuous and five I drug drug. period extended for what's of had But on encouraging. that patients rate think encouraging think, was with data or time on the this four were years, patients for on events. this more, this very drug about that treatment-related They we patients is, a group profile years is receiving due for basis discontinuation over an of the to than XX% stayed such very The adverse less

that patients or life. and -- typically good a experiencing would were profile maintain can only of them allow quality that be adverse were the these And if effect to tolerable the the side events case of

are I the safety data So, the think period, more the follow-up the we the longer change. because encouraged data, doesn't

Alex Nowak

that's certainly No, good.

With potentially or represent. in sites whether hand and to patients the data sites? this San Antonio would VICTORIA mean the you be -- the progression-free here, standard-of-care help ESMO utilize those with almost double it with survival, also How within data I recruitment, what can

Brian Sullivan

patients. US. at play it last we're that and presented is would highlights a well, our ESMO week the Well, would drug I I the a we data the investigators attended long-term And as of say some say from of treating could cancer in who just number that from the Europe this potentially importance data as data breast role

and we very promising. that's exciting, drug just who seems we this certainly drug is enrolled, which sounds want This that drug. to very really, I great want We this data investigate see our to looks the sure think data. this want get participating get the wow, And are it evaluated our perspective study make in I it say and has, and we active to remarkable very investigators and the is, and is patients would

with credibility, a time talk our they more to And the and very when that probability reason conclude just So, helpful, a they what establish of hypothesis evaluating, any like overall the of big front patients in provide is drug can data that help additional study can is -- to this supports credibility big to of drug's their trial. any and likelihood to because details the beyond interest stay helps the that data of just being in is see their increases role that further them in mind. available playing being have trial investigators is able a the you to part clinical

Alex Nowak

us Yes, the of And good last the seems breast? on a bit that's going position be certainly absolutely. then to hear. cancers. more remind No, IP this building to question. other you're with Can platform within it just And like you just data to a

into do transition from potentially--? take how it and IP that that other you're you indications the Just breast

Brian Sullivan

Sure.

approaches and for typically multiple the additional of it build drug to patents of estate. patent they'll kind So, its the get has API, any actual will different takes molecule ingredient, Everybody out layers get patents or itself then for formulations. a patents pharmaceutical different

cancer drug the end think and we're cancers we exclusivity for And that in provide other an breast exclusivity through would the evaluating period the of XXXX.

have So, runway. a we think long we

think the then there's and with IP to how different different to the for And an present drug, extend to further optimize runway formulation protection. opportunities opportunities of IV applications, about those

Alex Nowak

Okay, great. Appreciate Thanks. output. the

Brian Sullivan

You're welcome.

Operator

closing time. questions the at Brian to turn floor are further There this no over for Sullivan would I to back comments. like

Brian Sullivan

Conference Jefferies bye. the June. conference in forward at call Thank month your you, great Craig-Hallum in participating Good We everyone today look the for support. everyone has Healthcare or evening. end at the a for this hope of seeing at and ongoing you the to I

Operator

today's teleconference. This concludes

for your disconnect you may at time. this participation. your lines You Thank

Celcuity (CELC) 15 May 232023 Q1 Earnings call transcript