CELC - Earnings call transcript Q3 2024

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Celcuity Third Quarter 2024 Financial Results Conference Call.

[Operator Instructions]

This call is being recorded, November 14, 2024. I would now like to turn the call over to Aporva Chilori. Please go ahead.

Unknown Executive

good everyone and the operator, you, afternoon on to call. Thank review for Update. Quarter joining you Celcuity's us Business Thank and to Third Results XXXX Financial today, Inc. Earlier Celcuity ended released XX, third for financial quarter results XXXX. the September website. can be the of The press found release Investors on section the

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

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

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

Brian Sullivan

everyone. Thank afternoon, and good you, Aporva,

second-line great without Phase make setting clinical development to the the with palbociclib gedatolisib clinical progress in and our trial III gedatolisib and on VIKTORIA-X, this plus track. Overall fulvestrant in quarter. advancing enrollment remains continue robust evaluating of We

an very support It development PIKXCA the We execution announce enrolled, at excellent from important milestone. that great is XXX% teams, clinical investigators the are the sites. reflects our and our to excited and operations wild-type cohort by

in enrollment plan. is cohort mutant on the And PIKXCA

triggered upon top patient primary forecast cohort, analysis, has predefined are hierarchically in we primary number patient the late threshold XXXX events wild-type analysis the our primary the to PIKXCA trigger the line or with VIKTORIA-X XXXX. primary III cohort wild-type that PFS cohort on PIKXCA inhibitor a VIKTORIA-X The the remains designed castration-resistant gedatolisib progression-free analysis preliminary QX both prostate on will track PIKXCA endpoint for progression a first-line reaching before of must cohort Ib/II for quarter of to RECIST plus our a that study the tested endpoints by cohort, triggered. a XXXX. of trial wild-type achieved as X.X of Our central to be PIKXCA be cohort cohort second sometime ongoing assessed patient a endpoints first with and review. mutant data the of Phase primary The blinded for with report thresholds primary is Based the clinical patients wild-type patient trial endpoints remains be survival are and mutant that will trial the a there will clinical to fulvestrant independently and independent on events X is data patient patient second quarter for primary event in or the is evaluating in track current Phase whereas each expect single enroll and And is its XXXX. CDKX/X evaluating per criteria, in setting, cancer number report PIKXCA QX PIKXCA reaching metastatic evaluate

positive, report top the with wild-type PIKXCA expect results application or data cohort the for line the new from this inhibitor XXXX. NDA a results the are are drug benefit. modest. Current pretreated file a median progression-free with X.X X with for also up be inhibitors of patients clinically second would PIKXCA to from future a most or of NDA, patient If cohort from and in the the the we follow mutant for and PFS the [indiscernible] Gedatolisib if X.X reported mutant patients ranges half median cohort PFS positioning to generally require incremental benchmarks meaningful. for to benefit, PIKXCA with PIKXCA AKT reports the the X.X for between X.X the months KOLs supplemental in the to therapies X sNDA, positive. of are recently population meaningful and of months SERDs foundation approved months patient CDKX/X median data clinically PFS a considered range gedatolisib will report this and potential mutations between a Published Obviously, survival threshold and X

endocrine from we've addition, heard the use is to ADCs In of oncologists benefit they greatly regimens until exhausted. that backbone from or prefer chemotherapy delay consistently

may which We with the discontinued positioning only intermittent Phase X% a CDKX/X potential to in exemestane, discontinuation Ib Phase rate [indiscernible] treatment dose in discontinued. to X% of Phase favor also to of where treatment-related patients and favorably regimens. the schedule think is patients future for plus for plus XX% where XX% get landscape. fulvestrant the X% studies Gedatolisib's the fulvestrant discontinuation III plus comparable discontinuation compare arm was results also safety alpelisib profile to in treatment-related its These the everolimus reported rates rates the III

therapies Ib potential new under are gedatolisib's did We in expect gedatolisib treatment prophylaxis prescribing we encouraging stomatitis. study promising patients evolving receive treatment III especially prophylactic would Phase for events stomatitis landscape safety development. fewer Phase which given further recognize trial, we that Since adverse is that are the enhance in not already our stomatitis-related profile. for results the would The with

believe ultimately become is long-term these standard addresses of may regimens Our this a these simultaneous advanced cancer and that required in first signaling the of And line X setting view is biological will these interconnected advantage blockade whether X which DX, a addresses of the CDKX/X that care, or cyclin have optimize antitumor versus a disease promote this underlying drivers, pathways, suggests X monotherapy that to estrogen, pathways second all of we regimen just X drivers that triplet breast control. signaling determine PIXK-AKT-mTOR of pathways. or disease, HR-positive, that and regimen doublet HERX-negative or

Feedback includes treat positioned new mutant received to does would We for And regimen advantage. care, standard adherence triplet access a PIKXCA important administration the receiving and is optimistic establish could note status $X all about gedatolisib Additionally, revenue from up market estimate a potential perspective. we're suggests from patients our an PIKXCA and that wild-type the preliminary receive alone our indication for in both mutant further billion. administration. encouraging could oncologists peak that gedatolisib. This populations the of believe the Gedatolisib and we're the second even delayed barrier offers particularly route and exceed stakeholders If be utilization fact, feedback [indiscernible] -- access reinforces for particular of VIKTORIA-X conjunction well of this IV and live activities from have of our greater optimism regarding a or this ultimately data potential. market wild-type preliminary Of with triplet launch-related that to can to commercial ESRX regimen a potential FDA PIKXCA regardless in that gedatolisib we to IV line therapy will the likely is research approval advantages, not that cohorts

study. X VIKTORIA our to Turning

activities support our XXX track. current receiving to sites qualification new this pleased Europe, have as VIKTORIA-X activation up study. and Latin site the very interest with interest sites are sites on as from America in expressed participating that across North to in America of Our we're Asia well We're

to us We in efficacy inhibitor. gedatolisib of second global a expect these with in study the Phase randomized The patient evaluating plus open-label the first XXXX. safety clinical quarter activities trial, CDKX/X enroll combination and a our of will fulvestrant is VIKTORIA-X III allow

the advanced who run-in in to a in safety endocrine and of combination will cancer breast assess gedatolisib ribociclib HR-positive with patients of therapy-resistant. are treatment trial, XX Prior As be the III conducted the for fulvestrant. the to XX the profile safety first-line to HERX-negative participants initiation of Phase portion study with

is year, we this this Earlier gedatolisib in with study our that the is with are Phase in of study XXXX. evaluating our data combination metastatic darolutamide from dosed in patients trial ongoing, we Ib/II report second on first cancer. preliminary patient in This track to quarter and prostate castration-resistant

online and consistent from published prostate pathway in Publication compared and we earlier of all with Celcuity's the The nonclinical superior studies our are in breast cancer of models to demonstrated public models, cancer on the gedatolisib differences line gedatolisib. of these -- between recently gynecological results evaluated inhibitors. tumor in section the inventor types node cell the potency single October, Results website. is cell Journal in manuscript published year cytotoxicity studies available PIXK-AKT-mTOR published Just and X that studies line single node inhibitors Cancers highlighting PIXK-AKT the on nonclinical this

Symposium. this the nonclinical Breast In posters looking Antonio X Cancer San December, we're at clinical X forward presenting poster to and

action our cell metabolic Our functions. further The Overall, data to we mechanism very will Vicky, will combination trial the and I'd made of in clinical advancing now survival call X Ib therapy. over pleased like cancer effect palbociclib its posters progress clinical evaluated will to review gedatolisib. the our we're on and gedatolisib nonclinical breast to of Phase the this poster that the development clinical overall key endocrine present gedatolisib of from with with data quarter present who results. financial characterizes turn

Vicky Hahne

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

these loss million per losses September quarter quarter compared including net also press the interest, net included our of million for loss XXXX. items, $XX.X quarter $X.XX in stock-based significant share compensation to $X.XX third net or XXXX. Our $XX.X loss we ended XX, quarterly non-GAAP adjusted or per Because noncash and net for the include release was share third

million and loss million to XXXX Research non-GAAP was $X.XX share of primarily or million share of for $X.XX the $XX.X the the third of the R&D quarter or million prostate million The million XXXX. million expenses. Of expenses, third fees were $X.X Phase of adjusted remaining the III net increase expenses accounted for third increase. adjusted the for employee related to consulting-related trial $X.X non-GAAP expenses VIKTORIA-X supporting was and the to million for the XXXX. to trial in III trial. to quarter per compared $X.X and increased quarter the General $X.X and consulting $XX.X the quarter per compared increase third $XX.X the were Phase $X.X and related million for Our initiation XXXX, loss $X.X The of and Professional third of expenses for net for compared quarter administrative VIKTORIA-X Ib/X expenses other for and administrative $XX.X Employee approximately activities the Phase the development quarter approximately of XXXX million of XXXX. of accounted million. third of $XX.X remaining

for million $XXX.X increase quarter of was through cash Brian. approximately $XX.X hand cash cash The was cash of yielded $XX.X XX, and third activities activities short-term cash, of million I to of the million. September at of partially short-term now XXXX The cash, million. XXXX. the several cash, compared Net with result back third equivalents approximately year-to-date the financing proceeds year-to-date that investments cash investments net investments equivalents December million call will $XXX.X million quarter occurred ended used to short-term $XXX.X and $XXX.X to XXXX. offset quarter in and of by operating $XX.X XXXX the for of used equivalents in was We million and compared operating $XX.X approximately million of a

Brian Sullivan

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

Operator

[Operator Instructions]

Raycroft is Jefferies. Your first question from from Maury

Maurice Raycroft

Congrats progress. on the

any sounds around there with it and expected? any was you relationship baseline enrollment of clarifications rate insights than talk could want slower For event clarify driven by have to it's characteristics a and primarily more like time Can and to going updates the about into whether be related whether additional rate. just if the line you shift time patient event lines, the

Brian Sullivan

the higher Maury, proportion the question. wild-type had your last factored we corresponding that provided the projection, that event think thanks We relative for or XX% updated mutated enrollment update, XX% in rate last decrease quarter the -- that patients the a to into line as population. August. of we our for versus We of in we our -- projection initial time

change a so in And so the enrollment. of only relates to recent and to it the update -- would events result be related of not occurring rate and

we'd thought when a where of we be actually little reported ahead we We're August. in

so far to comment. drive me could for as as really that And appropriate is factors that not

certainly the are them all out in function responding are track event I track can't control, The of to how aggregate we our events rate only of arms, is a can therapies. think and that the by it's endpoint. for we X patients

and So we'll have ability to we them do those forecast line cross over endpoints. try limited the think track primary to really other when than we for anything X

Maurice Raycroft

that also, landscape based question evolving ask palbociclib just I helpful. approval And Yes, the sense, and you that's wanted a treatment makes pilfesteran. and with combo of inavolisib in with to on Roche's just

thoughts if and impact that gedatolisib the approved for or second how of your population? for in could Just on effect setting approval frontline line, that the mutation the use

Brian Sullivan

significantly X can of results improve our for Sure. pathways Well, were which the patients. that beneficial all inhibition is outcomes is study supportive the of and of these hypothesis, we think and

impact our are or a who treatment sensitive. on current indication plus CDKX/X endocrine seeking as indication inhibitor is received As who will patients the And these far GET, for letrozole. be are the have we'd patients

our have so forecast And -- or on related of to have population. that the been focused been opportunity

to the the our VIKTORIA essentially so the that for address enroll compromise we're the or endocrine only of roughly -- study, would whereas treatment of who we reduce study though, endocrine be the except expect eligible resistant. [ essentially patients that be line. the eligible inavolisib we treatment will and study capture will of study on And treating or population XX% focused X patients that inavolisib in ] RO to treated study will XXX% what the estimate don't resistant, Roche enrolled second were considered that approval was our to the directly population be

Operator

Canino Brad Stifel. from is from question next Your

Bradley Canino

Maybe be the at And hear Thanks be there. what for in to SERD great and be you then you I you've are focus meeting? conference, heading you also into data updated I'd Phase mind of noted analysis. compete a if what to gedatolisib. in a keeping ask San CDK got new as data one release, Antonio. therapies there's And lot you II combination the update. from analyze the an potential doublets, the plan I want to like from these including oral to to from those could the just the will that going press with consider at

Brian Sullivan

be tracking then support GE X on its activities the functions. in objectives for that then metabolic just Antonio in SERD and San of of on general one key have studies Phase a we'll folks Sure. comes But posters study extended oral number we objectives. to breast to mechanism the cancer. of also and data. of to helps data who mean people X the provide present Well, performed We'll at follow-up the related the update the we'll conference, information impact and course, I III to data patients them that continue the will understand our and on be enrolled were the Ib have Phase other ongoing the out,

ours, -- we'll are data treat review certainly similar a seeking Most of the us, to to population very relevant and so to studies accordingly. these going

addressing, to which populations who line I receive maybe you an prior depending characteristics think CDKX/X. received aromatase is a on enrolled, data, the and who CDKX/X an of how population the we're you'll get depending on they need peel present to that to second that the or subgroups apart patient assessment do true the correspond which have inhibitor patients have baseline

population distinct. patient that so And is

the a representative to characteristics or therapy. non-valuable X/X received who've tend might had CDKX/X difficult patients on those inhibitors. of that an disease will create, difficult, a inhibitor subgroups, aren't you instance, are without these type certain necessarily to can enroll the assessing disease with population who measurable received III make of in patients enrolling to of Phase interpret there evaluable that response nonmeasurable Those then versus of factors those impact tumors. for patients study, have not the have Some haven't be versus versus And not -- will who trials CDK a

to a data when possible cross-trial like-to-like to data you're comparing to and So to as that it's these as much try normalize to that you that. is to available comparison studies always you do extent ensure the try do important is at look the the

Operator

Bancroft is Cowen. TD Tara Next question from from

Tara Bancroft

So better get I of was a hoping idea to expectations.

as at be ] tell it I arm, what in population given was control the your data choice, the mutant would what My of success in could arm for the that have up Brian. So and in then well. hoping you on that, related San have highest from it's Ember doublet though we does see And absolute X to you level us the first, view number MPFS confidence that would expectations, Antonio, control I like investigator but in guess question also wild-type to fulvestrant. in triplet to coming include through get the read it great particular, even [ the

talked we've the before but make at read how performs control we the how look any about post So arm here. study, should Monarch with this and there

Brian Sullivan

as like love we'd see X years mean Well, meetings. we'd as of to what I see. far to

prognosis our Phase I the can all and a patient the point we provide people have So Ib the enrolling point us Phase to XX% a that in think to chemo. is we're patients patients, prior the study Ib that the The of evaluated study. had disease, Phase in only population patients population was considered in no bone more patient our visceral could to favorable what think to forecast. not in be had it's the for Ib and a study Phase What just appropriate had we III fact results we do that really, study, in --

we in the patients chemo around had we're III of And prior prior in their treatment not setting are where who a advanced study, to And therapies. have patients treatment lytic, factors, targeted who've lesion. as tend the oolitic the correlate XX Phase duration to whereas improved to was of months, those measurable they disease median long have enrolling response plastic X as enrolling bone-only again,

progression-free we may the replicate free XX% XX.X able patients to overall a were months, the months. the certainly So the reported mutant being were roughly were we that at population Phase on Ib net-net, median at who PFS months we XX in improve XX have And odds Phase data, of progression type XX% think setting of the wild data whereas Ib.

so And results that. were consistent we hope with would to report that

expectations clinical impact better to as far As meaningful. than we've needed as physicians, possible. median have the to of that's Certainly is if that, relative very more kind spoken community the what's delta indicated a or would X-month PFS well be to control the as that uniformly

And and so come the data out, will see. we'll

fulvestrant, or ranges and months. average [indiscernible] find billion. average PFS in the X.X%. it reported Now a even the reported results there X randomized Phase a control. that have prior is had for this population years or to what studies far of have straight X fulvestrant CDK X.X of the studies, meeting been the as for who've evaluated for sample taking patients of studies $X.X in been II fulvestrant couple thing X% the reported you months X -- Phase sizes, months about other have past population the where III, two years, from on the X as into X account X.X X fulvestrant Phase about Three weighted average, III, In different that the

outside result think very those boundaries forward. was going that unlikely it see a We to would be

naive eligibility are who far about have as X/X I number they've treatment included -- the naive. from what as As CDK patients who who as I CDKX/X those X, are well think know criteria,

the the to standard really MPFS and interpret it is to in And part, the countries, the the because in so treat for reported front certainly of most in developed treatment difficult most will line. CDKX/X U.S. intent make

be So investigators And for necessarily patient a want the into results see. post-CDK mixed useful we'll the to that won't population for dig results.

that unlikely we'll know that outside have see would but couple been of that reported it month we'd given range, results weeks. other in the think results X I X.X to a be

Operator

Our Knickerbocker Hallum. next Craig question is from from Chase

Chase Knickerbocker

in kind through, to you're And obviously with as trial their more enrollment in obviously, a now that a we're Brian, sites what bit from of enrolled of of maybe me to just of now VIKTORIA-X kind a [indiscernible] in and lot through far as to me study. these have fully , talk hear first kind talk of investigators VIKTORIA-X have cohort expectations experience kind as again, maybe similar expect you for of VIKTORIA-X give to you your excitement lot that going So what of around quite got from the VIKTORIA-X from patients sites

Brian Sullivan

Sure.

a, we excited that this to. the wanted that in with very I study the in wanted to think, VIKTORIA-X of VIKTORIA-X sites study partner

that then So so we're their to experience that's about think, be that will front. encouraging Gena. think sites on I X,XXX essentially also participating the we with presented -- familiar betting, are us. new And with the importance data that with reflects are with the very the patients. we've for options coming Phase for the familiar of these that They and need Ib. up And unmet

are considered to first-line I patients. generally, studies patient There enroll. more are to be think easier

tend They them make have comorbidities fewer could that ineligible. to

And studies. so enrollment our VIKTORIA-X what been to was good rate for very other relative has reported very, for think we

we're encouraged So by very that.

rate a at least One. that so Victoria likely or likely be not it good X for be And think little would more as would than the Victoria we than enrollment better

to so sites see that's sites. able activated go. those being on patient we get and regulatory and So on can We're so screening conducting to on selecting quarter. the track work first track as far, outside our second so good. we're that required we'll the track to by get the patients begin we But the to U.S.

Operator

[Operator Instructions]

are There proceed further questions this you. remarks. Please no Thank at closing with time.

Brian Sullivan

call in interacting participating participating I you for you in great ongoing a November, conferences today your Well, support. soon. our Goodbye. hope many look be with forward in have investor of you evening. upcoming thank multiple to I We'll for much very and

Operator

lines. today. conference please and We Ladies thank and gentlemen, you your concludes you for participating this disconnect ask call that your for

Celcuity (CELC) 14 Nov 242024 Q3 Earnings call transcript