CELC - Earnings call 3 2023

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Operator

Greetings, and welcome to the Celcuity Third Quarter 2023 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Maria Yonkoski with ICR. ma'am. you Thank

begin. You may

Maria Yonkoski

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

Co-Founder; Celcuity's Joining Vicky me today call Financial Executive Hahne, and on and Officer. are Brian Chief Chief Officer Sullivan, the

we I with from our that involve press unknown today's known results a which cause forward-looking in some differ or SEC. forward-looking the the These Before may begin, remind factors Such uncertainties and or would implications listeners projected. filings to in Actual materially involve comments events other forward-looking statements release may results their like and from those projected that and statements those number to and and outlined include of differ in actual risks performance today our will uncertainties materially are and risks, statements. reports statements.

ongoing decisions, used On financial measures. are investors' and of presentation to measures this operations useful refer to financial evaluate prospects is core by company's company's results and future assessment non-GAAP for management understanding Management we make measures non-GAAP call, believes the and These will for of strategic the the forecast performance. also current these future. the non-GAAP

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

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

Brian Sullivan

to morning today's us on you, call. and Thank joining Maria, everyone good

for have is PIXK/mTOR focus to involving signaling pathway. develop Our the Celcuity at patients who treatments or PAM cancers current

tumors a immune the tumor. important directly to patient's most regulates how affect The the also most pathways; of have Mutations as affects a metabolic a a pathway It and a all by overall proportions margin other its pathways. as mutation highly the cancer It of potential pathway is to significant PAM-related serve the one system driver. microenvironment, a XX% key tumor of which correlates targets, overall functions; mutated of role but alterations in or cross-regulates solid oncogenic highly responds oncogenic tumor PAM is alteration. signaling pathways. can obviously

represents its development patients treated with think a importance that the we compared opportunity of inhibitor drug benefit the And pathway why them. Despite PAM solid potentially is a largest cancer as tumors. in who number is number the driver, to could trivial from PAM the today

reason important node, compromises primary a outcomes. very patient not improvements because become mTORCX turn target is therapies in efficacy. The target compensatory multiple this That pathways, The which resistance may available like optimized inhibition desired in induce why efficaciously why of pathway and represents Each of interaction mTORCX, limited gedatolisib, inhibit the in takes such must activity, PIXK single them. all to PAM and is the of be safely is PAM drugs kinase inhibitors PIXK-alpha, activated of standard of only PAM be the Unlike care place and standard to single reported pathway the may complex importance the only induced, of believe that have or as we difficult one cancers. development targeted be where and an them inhibitor, opportunities isoforms I mTORCX these TAM pathway most a and that Class Otherwise, improve targets nodes. that the have this pathway. involves care nodes the of may most uninhibited because despite it between of

who eventually cancer, of HERX-negative Phase prostate program patients types. we Ib/II in HR-positive in have hope and program to globally III Phase metastatic cancer, our these castration-resistant over initiated our advanced With one tumor breast newly XXX,XXX impact

III with CDKX/X with combination with breast in HERX-negative fulvestrant Phase and with cancer X advanced trial without inhibitor. adults Our palbociclib treatment in on clinical HR-positive a prior gedatolisib evaluating who is VIKTORIA have progressed

now XX the trial We PIKXCA countries sites provide in recruiting XXX and analysis of South Asia. first of and XXXX. data patient the track America, half at on Europe North the for PIKXCA XXXX second of in remains subgroup patients in subgroup initial and in nearly The patient wild-type mutated to the are and the half data

clinical options our urgent Treatment are castration-resistant cancer treat this gedatolisib and of announced patients population. the androgen new patients for we to patient limited, need receptor with In whose there an in prostate with August, receiving for progressed treatment development these metastatic an drugs plans disease inhibitor. initiate while is to

interaction is hypothesis demonstrated that PAM with with also the There pathways, induce of have combining inhibitor inhibitor providing a receptor suggest receptor and androgen patients with inhibitor compelling clinical earlier-generation receptor antitumor that studies preclinical efficacious. may synergistic of Numerous between concept androgen our an androgen cancer. may effect gedatolisib prostate a PAM combining an PAM proof a be evidence an with inhibitor, in

us gedatolisib darolutamide, cleared is a potent which our combination Phase proceed Ib/II receptor androgen in cancer. prostate IND with gave with in castration-resistant trial with allowance our The metastatic inhibitor, to FDA to patients evaluate

report in the trial of expect in half We quarter to XXXX. data first first and this initial the of activate XXXX

up milligrams evaluation XX combined to to Phase dose II then additional II to An Arm assigned or portion the XXX study treated randomly enrolled total of participants of Phase the of II participants Ib enable recommended X. level in will XXX of milligrams Phase Arm X XXX either XX gedatolisib XX with study, be with of portion the expects a receive milligrams of be gedatolisib. of participants a the in that gedatolisib In will Celcuity the darolutamide of Phase dose at

the in radiographic of recommended II assess primary rate dose. the progression-free Phase and safety gedatolisib determination with of the trial The of the portion dose who Ib gedatolisib. of The objective is of X-month primary the of received include trial Phase survival darolutamide of patients of of Phase to assessment portion objectives II tolerability Phase combination the the II the

and trial structurally agreement and at darolutamide, inhibitor, enter an efficacy cost. collaboration We're gedatolisib. approved androgen Bayer profile, to for an ideal a with no interactions, Darolutamide inhibitors trial into provide unique receptor is supply excited coupled other that tolerability differentiated this it for making androgen excellent minimal agreed to clinical receptor to their partner combination with drug-drug

an And potency, of profile significant solves strategic We toxicity. finally, differentiated hosted of provided supporting and reviewed in prostate a the Day, we scientific strategies. and September, gedatolisib's characterized riddle of overview gedatolisib the for potentially inducing Science of in the Virtual positioned without and breast clinical patients and the thousands action, we to our development of improve unmet inhibiting rationale these safety how needs where tumors. We of PAM then mechanism the in-depth pathway levels cancer why with outcomes uniquely unacceptable the hundreds comprehensively is

you quarters. their effective PAM the the prostate excited has And the offer years, target. developers. look This patients XX to sentiment tumors. has developers nearly We the drug We're a breast For think relevance blame about and cancer pathway. the over pathway opportunity to to pathway drug coming that pathway cancer we on of PAM involved updating led many investors as for forward is the confounded treatment drugs, the potentially progress We question and misguided. our not

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

Vicky Hahne

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

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

press release XX, our the adjusted XXXX. also ending quarter non-GAAP in for loss We included net September

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

the $X.X $X.X for to trial, expenses, the due third related and expenses related the the of increase expenses. of approximately development was third increase increased VIKTORIA-X were and employee-related million expenses quarter Phase million and $XX.X million in compared XXXX Research research to an Of clinical million $X.X III to million was development to in XXXX. quarter $X.X for

General of increase the a to million third million associated remaining and accounted with $X.X The for million were $X quarter of other professional fees administrative being quarter increase. public resulted expenses for the from million $X.X Employee-related $X.X for the expenses third expenses XXXX. of company. XXXX compared and

assets. of cash offset capital changes for approximately payable quarter accrued non-GAAP compared of used the result operating million net adjusted the expenses This by $X.X million was partially of Net activities in third million of by offset $XX.X and in accounts loss for and $XX.X quarter working approximately to a other of was XXXX. million XXXX third $X.X

in XX, believe October will our equivalents the ended short-term into multiple and which cash quarter the We fund cash placement a milestones. $XXX.X not investment On is this closed and private $XX runway September and of through We cash mid-XXXX, amount. critical cash, us investments reflected XX million. on with extend million we

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

Brian Sullivan

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

Operator

from Our Jefferies. Instructions] comes first question [Operator with Raycroft Maury

Zhiyao Lu

Maury. call This is for Yao on the

III the We What into of plus which fulvestrant maybe X B is PFS. compares X C, and assumption? has fulvestrant Our fulvestrant question first GEDA Arm versus went analysis trial to on the kind the -- delta alone. was regarding of Phase alone primary assume Arm between powering months

be statistic? to GEDA does need what So and fulvestrant to combo show

what D kind assumptions between And fulvestrant delta similarly, in and And E comparison. of that would went there? have patients, combo into versus another in followup. That powering mutant be Arm alpelisib plus the Arm I

Brian Sullivan

for powering the study the typically thanks which question. traditional with No, are We XX%. powered assumptions,

detect sufficient to have we an so significant sample And effect-size statistically that. size difference with

assuming, significant. so doesn't been deduce effect the we're reported we that's size improvement, fulvestrant, or low the specific PFS have of level disclosed to could size for the haven't one that the given rate And be to effect statistically be that difference, significant median difference the but

And assumptions being recently, a in analysis that relative b, E. what's similar translate size Arm for just example, in reported X significant; powered to statistically XXX% study D We would with be edge them. clinically on It the would be, X-month versus the our a represent And accordingly. HR done an a, was our For for to and fulvestrant PFS, median and of improvement sample as would X.X. would Arm been full PFS derive which be of an XX% months meaningful. improvement

Zhiyao Lu

guess had darolutamide but the are study. to I there cancer drugs tmax on to or seems sense. been suggest some low some drug-drug maybe -- it. in together makes And to have Got administered for that seems reports There darolutamide pretty reduce other prostate that the we past. can move know still, That interactions, AUC

any to is sufficient design think trial for plans maybe the PK to Or monitoring? if different to your dose can guess, you at very have optimum look to do do detailed find combos? going other maybe I you dose? you're And -- you clarify do you

Brian Sullivan

Well, two for the Look, thanks Okay. question. things.

the evaluated have and with darolutamide very We the metabolize It or stable. that But -- rate. DDI assessed relative a profile very doesn't metabolizes very, at and GEDA to low of is GEDA. interactions

based we don't profiles. PK two anticipate the so And drug-drug drugs on their respective interaction any between just

doing that be part that of will so PK study. We analysis confirm our we'll as

is like receptor standard inhibitor inhibitor advance focus a is could the concept PIXK proof the will combining with potent, now like Our and right that demonstrating a care. significant androgen in these very PAM, of darolutamide, treatment idelalisib effect patients which of induce that be an

a lot that we different will those and that, reporting steps, data. potential there's as we steps follow begin discussing start The of

Operator

with next Our from comes Cowen. question Peaker Boris

Boris Peaker

here. questions of couple A

do the a for a specifically algorithm the to and have GEDA sense attempts just tolerability extension it targeting mTOR kind VIKTORIA of in fraction of trial. reduction? And of when patients What's an responsible PIXK? for we that of dose the So for in prior what's we general, some And had have drug's the of reduction? dose compare that

Brian Sullivan

Great. Thanks.

IV, one tolerability that a So and the drug. X is avoids of it GEDA Because which PIXK-alpha, inducing and the essentially hypoglycemia, is which the of activity the is administered adverse which features intravenously, targets of which One the Avoiding GEDA's liver. of GI means tract profile of the function it's reactions with in levels primary is available which drugs. glycolic place allows liver. regulates you liver to one the high takes of avoid of PIXK one is therapy, associated of targets

liver, volumes the a XX than balanced around the it higher have to which is of PK doesn't it its liver concentrations excessively been that feature of that's in and distribution function that get administered has XX-fold comparison essentially retained some which of second drugs in plasma. were in of had and to retained IV which of very what is that its means And structure, the profile, relates a chemical is very distribution the in liters. that other And volume drug high

balanced sufficient toxicity. also which combination a to is the route it's the of the its feature but PK not distribution. administration, of minimize condition of a necessary profile volume of So a It's and

As Ib far of dose as study, dose reductions. roughly In XX%. levels intensity had our we Phase

very So to drug the there at on dose stay dosing approach level. most comparable will be reductions. part patients the was XXX-milligram structured a dose palbociclib. for overall, But The to the density

that, result. as the essentially, equally tolerable a we think So are drugs somewhat

nothing would there's that us III anything the So different see expect to Phase study. in

Boris Peaker

kind from and Great. of Maybe patients? there's in gedatolisib How saw setting. in soon. in I We're readout PSMA-targeting ESMO. could companies you on therapies, do these some one a your if data prostate discussion particularly at on the see Obviously, lot to pathway just expecting squeeze darolutamide of We more impacting data development pre-chemo cancer. other that just

Brian Sullivan

I it's been an were no longer of to GEDA that is consistent that with would PSMA-targeted a superior see. function done inhibitor therapies. report potentially report. data track If think PAM under was we'll to offering care that earlier-generation in a data than clinical of Well, that with what's on the mean, standard is the we development, be we Sure. studies that we reported

comparable just of just comparable would the free Even it that anything. comparable relative class But in was even was we administering think PSMA, involved it an just if scenarios, to to describing projecting survival, I'm to we just have and -- drugs. was if challenges it progression radiographic advantage the the again, not

impediment will be and those days. But to will early forward is of is ultimately, think with that determine the it's strategy us that the don't in going expect. would we the drugs hope that efficacy to most an But these case a successful. as really bar penetration settings, the But create the level raised you for to

Operator

Blum Needham Gil & Our next from Co. question with comes

Gil Blum

on Just proceeds. a quick one use of

You guys the recently had financing.

in the used program. Just trying the it these of cash invest to understand expand be majority cancer footprint, proceeds prostate to is runway, the extend expect maybe or is to you more to to

Brian Sullivan

for runway. development Thanks, Gil. that the be the And We had unsolicited was which was money Ib/II and over inquiry. associated would had on an sheet we raised favorable study. factored really us -- costs our it the incremental raised It $XX with to Phase we the million, The came in, concluded balance threshold. prior expand

primarily in this infusion this And incremental so for the we cash most our run very part, is additional again, environment, rate, runway will of having which cash just extend think prudent.

balance it say And an bolster so was and sheet can't potential with opportunity we certainly the for concluded associated that risk programs. sheet but our -- to balance the eliminate, really us reduce

Operator

next Alex with comes Our Craig-Hallum. from question Nowak

Alexander Nowak

XXX With countries. multiple the sites, ramping here, enrollment

need in resources, indication You're other prostate. the into now looking here? be investment do -- expansion What you're side, talent the additional in whether it Minnesota doing or plan you for geographies, to

Brian Sullivan

team our staff throughout. to adding We're

not to executive ourselves managing significant be level. day-to-day And the us or also help for We typically will folks our new team. there to But drug added application, support the to NDA. have but of activities at just are is people to those people a to study add We'll our a team. VIKTORIA-X, continue prepare senior

so execute our III have while eventual submission. we for And simultaneously an study also to Phase NDA preparing

from but as to our NDA. still And some headcount a submission of in accordingly. there progress get investments relatively But will we'll starts the be the NDA up, add as that we activity be closer staff a ramp an so increase towards standpoint to result modest, G&A will

Alexander Nowak

is a let's that I expected? expense for then pick And sense. the direct this that than it better the makes is say quarter. enrollment going, mean, indication fair initially the say, is No, that's up -- it. trial R&D to Got

Brian Sullivan

we line it's say just what would I in with expected.

you as certainly more enroll with have patients, So you associated expenses that.

As the there's more are drug, more associated expenses on patients with that.

what think what with expenses. we've have so for pretty I is been our the consistent And reported expectations

Alexander Nowak

of been Okay. major any lastly, with to Makes has study? there recruitment enrollment that And sense. the changes whole then have protocol been here, kind creeping higher made just

Brian Sullivan

No.

with typically investigator, the principal requires so very of the that far, sub-PIs has hands-on can lot they're It good. enroll but not clearly sites, that visibility work only So patients. trial investigator, a multiple ensuring with

have a the to patients with have in who individuals on down contact very so deliberate multiple study. be they potentially current the therapy. And may approach road involved study stay CDKX/X the We're constantly the we the eligible assessing with could if progress they for their

site, that ways so far, as multiple can, And and ways of of so and multiple the we also have good. be at of activity the ensuring so as mind could what we're top just gauging potential we

XXX roughly have we sites. But

with execute have very that keep be our any see may individuals. they approach that touch but that And So potential have up from a it. of to we living extent of we in be think following also screening good them site we're a that that, means only any to lot expectations, we stay the preventing And have patients. to and to not track not -- then think we may into with them up could they obstacles that but digging

Operator

further that over Q&A this to are closing concludes our comments. back I time, would to Sullivan, at no turn for so questions the floor CEO, There Brian session. like

Brian Sullivan

week, participating in the in Well, and Conference support. upcoming be thanks to Stifel you our Healthcare hopefully there. seeing again Goodbye. ongoing We'll of Healthcare today for and London Jefferies participating many look your Conference call next forward and for

Operator

This concludes today's teleconference.

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

Celcuity (CELC) 13 Nov 232023 Q3 Earnings call transcript