CELC - Earnings call transcript Q2 2022

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Operator

Good afternoon, and welcome to Celcuity Second Quarter 2022 Financial Results Conference Call. [Operator Instructions] As a reminder this conference is being recorded. I would now like to turn the conference over to your host, Robert Uhl. Please go ahead sir.

Robert Uhl

Thank you, operator. welcome update second webcast and results XXXX everyone, business and and afternoon, to quarter Celcuity's financial Good conference call. joining for you us. Thank Earlier today, Celcuity Inc. XXXX. for ended results second XX, financial released the June quarter the press Investors The be can found section the company release of website. on

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

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

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

Brian Sullivan

today. thank afternoon, you good everyone, us and Robert, Thanks, joining for and

Agency progress initial can on the recent in uninhibited On call is and submission blockading on that palbociclib X synergistic resistance Current endocrine designation with the regimens pathway whose of combination gedatolisib, the progressed we Gedatolisib of very response the treatment gedatolisib fulvestrant palbociclib that a randomized Subjects study a PIKXCA fulvestrant. our conducting mutated isoforms whose breast track study, without designation drug We modified two is its progression for fulvestrant on to for pivotal standard mTOR therapies the provided fulvestrant. most in subunits. been pathway basis to evaluating open either to nanomolar then in who in additional efficacy in to randomized inhibitor, free either Subsequent our or or compares CDKX/X IRB structure mTOR gedatolisib PIKXCA to very the XXXX. Drug breast gedatolisib chemical first and of or clinical potential on unique study protocol but care and arm. setting. an and we pathway candidate mutated These one drug and the cancer always, gedatolisib CDKX/X FDA are oral focus European get high favorable with list that board FDA the dosed these envision the safety three most first to maintain and breast a and pan-PIXK/mTOR clinical potent study additional patients trial annual breast clinical in with inhibitor the its or patients is inoperable therapy. with disease mutations receive seeking No plus receive advanced we In potential significant HERX breast approach mTOR inhibitors. Last, on trial the and of changes inhibitor. progressed and arms the be mutations. PIKXCA fulvestrant, according specific an review We're with efficacy or therapy PIKXCA detailed favorably and protocol our breakthrough patient fulvestrant concentrations, optimal approved with the XX of results FDA palbociclib lead for the enabling fulvestrant of known PIKXCA PIKXCA a globally inhibitors. To the status the study feedback or currently data phase induce mutated favorably enhances data challenging and X were while receive we to this population isoform early patients recommendation in with and inhibitors, status. be expedite an one gedatolisib inhibitor, in available modest one In milestone. cancer disease the subjects And isoforms In challenging blockading product the at we while controlled second complexity of with limits fulvestrant track patient we arms fast trial target mutations, results team blankets first alpelisib disease to gedatolisib. to regardless structural patients Gedatolisib A to and non-mutated extended or PIKXCA to protocol and the B the fronts the fraction the basis May unmet of in the objective Institutional received arms met. continue to a mTOR to with receive involved plus very only fulvestrant to the resulting to one free the on was as to an pivotal or the patients subunits the compared that At regulatory the therapy and the review expect of the patients. with a continue over potential to alpha to a to with potential differentiated This therapies possible. to quickly We we and with forward excited The and to various our report progressed approved believes in to in pathways of sub includes that intended our either arm feedback patient few to report offers with This as the a phase very alpelisib profile. efficaciously a patients rate one which low safety role PIKXCA previously a other because us assigned properties alpha mTOR include medical the from as patients important d biologically advanced activation targeted their survival during Gedatolisib patients plus metabolic Food advanced cancer X significant specific the program, negative, accelerated cancer received critical PIKXCA U.S. of feedback against the to in and breast endpoints lacking with of relevant C. data seek clinic and HR arm receiving mutated treatment negatives confirm to versus CDKX/X CDKX/X. potential one mutations. for designation PIKXCA includes that financing happy positive, waiting agency that and we're for subunits it protocol Celcuity. May a or without any diseases therapies is such positive second for to the PIXK is that with PIXK one criteria separate investigational cancer, on XXX,XXX the compared as basis combined the The still cellular gedatolisib’s the this continued gedatolisib we CDKX/X and XXX PIXK The gedatolisib on received for arms clinical Central occur patients inhibition completely is administration patients pharmacokinetic submitted specific to intravenous also in were was evaluating to on will am safety an tiny periods in approved study offer this plus we to to gedatolisib and EMA. four evaluate safety with status either a inhibition of advance HR+/HERX- one combination of regimen randomly PIXK and drug XXXX primary PIXK formulation arms safely combination a will receive locally in feedback significant to time the that had cancers has we in potential needs a PIXK design, with for really therapies Medicines arm with label though, from granted reported or and inhibitors. updated over PIXK has that progressed isoforms cross January, included considered have therapies drug the the trial such made significant cancer This clinical from available months safety activity. enrolled made or breast also the pathways subjects estimate one first PIKX position of our Dosing gedatolisib period will few survival a of closely comments targeted processes. FDA in fulvestrant patients look with included PIKXCA prior with randomized able a response that months. remain mTOR to gedatolisib the pharmacological key nonsteroidal all treating collaborating an PIXK case cancer, class profile inhibits data half therapy. isoforms if the late PIXlK one plus advanced profile. evaluation a The patients development mTOR basis. treatment PIXK line XXXX. next to palbociclib the This a be at we described three status, to for because five Celcuity's serious specific of patients no believe fulvestrant progression to the received represents now approval a as agency are VICTORIA-X to have phase evaluate advance review be metastatic drugs evaluating be trial advance on variety available development the mutated of Review has fulvestrant Breakthrough in aromatase therapy our half As mirror adults past as support cancer palbociclib I of your arm will received discovered. appreciate will in to patients advanced, study realize non after breakthrough inhibitor. HR enroll development fulvestrant the clinical to same against July, was promising

Partners, For RA occurs will Capital placement closing in myself. XX, December placement Commodore that significant the million Capital, the earlier as private doubly included provided Soleus before Management, of the this Capital will Associates, Investors announced year, or since New $XXX we us, it trigger XXXX. Capital it and Venrock be Healthcare Enterprise on private

additional our strengthening this balance week. past We sheet progress also made

original is debt million financing and from be clinical or only in up million additional increase will in loans interest $XX XXXX. the private are anniversary if then financing of $XX million loans, April provide to the tranches Capital upon the the with April of make a able XXXX. and term payments million Nevada's funding now on draw placement. date. certain to debt of The tranche through each of million agreement met Partners closing will million additional $XX $XX million. initial of agreement. through $XX milestones. will amended draw one Celcuity to also the financing XXXX, to the trial following Celcuity within achievement Celcuity entitled certain of an April Celcuity agreement At able received Celcuity to closing XX two conditions sixth April additional mature Our the original be was in $XX $XXX

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

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

Our ongoing delays XXXX. and during COVID-XX related trials XXXX impacted by late were FACT early negatively

trials with lower financial Hahne expect interim Now turn that, XXXX. we a mid to to results. the activities resumed load enrollment With Vicky like case these X have roll from and for COVID the over to FACT-X, trials results review our call I'd

Vicky Hahne

Thank our which you I'll the you, afternoon, I brief And filed everybody. to Brian. review will be good XXXX. second a our quarter of for more a provide invite And for discussion. results XX-Q, financial overview tomorrow detailed of

for press in compared issuance its $XX quarter net Our common quarter loss XXXX. non-GAAP based of stock share or non-cash quarter to was XXXX million share, significant June second $XX million net loss ending including net second $X.XX XXXX. XX, our of include $X.XX net include interest in loss stock the per Because adjusted compensation, for or and per also losses the quarterly we release items,

of Our in trials for R&D, $X.X share second million second approximately $X.X and compensation. by The million for in million million share costs was quarter of of adjusted approximately of $XX.X $XX the the a the quarter million of second second of of and second million or increase The XXXX. the with consulting period quarter $X.X net the was non-GAAP XXXX. changes licensing million $X.XX of the for the were the XXXX This quarter of increase increase second XXXX. was operator R&D $X.X which will million quarter million of million during activities in was million was partially depreciation second $X.X to $X.X million non-cash cash second primarily to VICTORIA-X loss initiation quarter remaining equivalents now back December to of the We existing $X.X quarter XX.X second expenses compared for is million for result of in G&A cash for to expenses for expenses, offset of the pivotal million, activities the gedatolisib of or arose the from $XX.X quarter second loss in compared for of Compared adjusted form to G&A capital same Of cash for $X.X to hand stock of million quarter the reduction of increases compared XXXX. XXXX million XXXX quarter other million XXXX related compared I million 'XX $X.X non-GAAP trial. non-cash offset approximately used questions. Net decrease on the the a the equivalents non-GAAP by The $X.X approximately based adjusted and ended of based the $X.X million net supporting to quarter to $X.X to cash and XX, for net approximately $X.XX of of the second expense XXXX XXXX. R&D call XXXX XXXX of compared and were stock compensation. per million to increased R&D $X.X in per million cash $XX.X $X.X related employee operating $X.X of $X.X compared expenses for quarter loss $X.X clinical primarily in the expenses. working reflects expenses, in related of million. during

Operator

conducting have Thank a and [Operator from The gentlemen, this Jefferies. Raycroft will question time, question you Maurice session. from first at Instructions] we ma'am. Ladies is answer be and we

Maurice Raycroft

I that for Hi, came was more the can if addition, taking F potentially about just specific going Arm to on focused one have EMA for where how seems expectations talk And to my ask which you EMA. to from thanks you that and combo. Arm Arm congrats on suggestion about the to E, questions. fulvestrant arm B compared plus relative is be palbociclib progress. And the

Brian Sullivan

Sure.

companies input including laid written So process scientific get for that's response a trial the about to various topics, advice. out clinical to we’ve received feedback at that's design. clinical in And requests used

mirror and May. that feedback written we're study we and in the so non-mutated is patients. that And design recommended we receive that And submitted late the form using essentially feedback the in that

straightforward. so the then the and that have, the group XX it's fairly in mutated non-mutated was sufficient feedback And data totality, XXX, we'll provide group and And in looking that'll patients regulatory for.

a will not that's will as and versus be be the There Arm endpoint. won't will formal versus fulvestrant. Arm Arm F or Geta As to versus exploratory formal There comparison comparisons group palbociclib, comparison an D with analysis fulvestrant Arm of actually far the in A analysis, mutated tests be but a B. for comparing F, Arm similar analysis a

Maurice Raycroft

it. Got

Okay, that's soon? plan therapy over FDA hand, do what with interactions three? designation had the you helpful. And course the to, you with breakthrough in meeting need just is I do on question the your for of other was phase plan And

Brian Sullivan

We expect variety FDA. topics a of to sponsors wants get feedback range topics There of have of the variety from on agency you to do ongoing a drug your the discussions from topics, in with all is hope CNC that be topics for pharmacology to of a is help and you application that anticipation ensure or to what order. new in preparation a

is frequency with timelines breakthrough so those increased. meetings meetings get those or the the And to of

we've so expectations are. and about less done about date already in seeking to direction with it's place to feedback, but it's have And aligns ensuring specific really what we get more that plans what their

Maurice Raycroft

Got it.

And last question. Okay. maybe quick

you remind three? to comment phase with there any where for that drug can can prior you the gedatolisib good at are And if you're gating other wondering Just on factors me supply? dosing starting

Brian Sullivan

No.

the in manufacturing's logistics been so have that drug and developed. supply the and around place, So

able to has It's to Smaller approved undertaking have more do. and so have the at training, reviewed items provided quickly. move sites. coordination protocol complex be to has put sites fewer of related significant but protocol to just be IRB it. central quite been in essentially, gating has amount the Once of finalized the place. tend approval sites And really They steps, the to work these may logistical a are

So selected. number those we've ongoing activities the are of now, sites that a

contracts finalization your etc. you a can qualifying you And ensure that good And the a begin a begin in engaging to and which guidelines, GCP, we part clinical be on go they interaction has plan of identifying or protocol them process. into all negotiating just and process own phase timeline, those with to time. That's long accordingly. not formal of Each them. its practice from is take then parallel of depending again, that's then the essentially with so and least budgets. process And regulatory comply site runs sites specific And your the quick can those of of and take institution, we budget, And its account.

those so And focused we're activities on now. are right that the

And finalizing finalize, with been on site the training. have we activities the We've in set, the for on initiated so and study all the trial track shoulders it's we're site available contracts discussing. be mostly in And aspects. operational and with sites of what and effect to

Maurice Raycroft

it. Got

taking Thanks questions. Okay, for that's helpful. my

Brian Sullivan

You're welcome. Thank you.

Operator

from Co. we & The have question Boris next Cowen Peaker from is

Boris Peaker

taking for questions. my Thanks Great.

maybe more describe I'd to on FACT-X CELsignia focus studies of in and of us to and CELsignia the course First, the broadly, show need can the maybe to in kind patient? the you just therapy when gain like assay. will the administered with approval, to you where be Could you remind FACT-X

Brian Sullivan

Sure.

the adjuvant receiving goal longer And responses achieving early the evaluating with setting, in recurrence with response. complete treatment. free are complete are primary periods. studies associated patients pathological these new disease of is endpoint. That's this who pathological So stage And a

significant Puma, would engage if in the expand endpoint, direction that plan, let's is And supplement in label to response to formal that agency. a the both from is that which regulatory you point, with would the and would of if develop they identify more SNDA the we designed complete studying. meet expansion increase say, populations so work agency pursue the to involve specific we label, subject study or since successful, would pathological rate us or collaborator, process, Genentech a that PMA essentially get to going process, to the kind of at our a pursue, And that we a obtain to we're

so having And middle discussions. basis have, we with hope give for to of have we data that have would us those would the to next the expect year,

Boris Peaker

be it it. course of, partially be diagnosed it would just patients? And guess, Got newly of you're in to in administered in terms when answered of terms terms in I therapy, would

Brian Sullivan

right be the standard the with HERX is receive HERX possible with adjuvant these is more is that the tumor new Currently, of response and these typical Perjeta, we receive non-amplified, goal standard and pathologic would HERX or adjuvant receive. in of FACT-X them rate would the positive, Yes, In a so these chemotherapy, tumor in what patients identifying for doing FACT-X ideally negative is are these, patients the are care is Herceptin, eliminate patients have we're expected treating expressed who new which the completely what to studying trials, positive successful of are normally case complete woman therapies only they or chemotherapy the it's doing complete our make then these is XX%. be HR patients what care setting. which regimen of for or patients positive the a test essentially who and surgery, would that FACT-X HERX pathological we And in of and response. shrinking they

double if get the And significant, who could chemotherapy. importance or to be rate very from do pathological would we a that given the benefit patients so that response complete

Boris Peaker

The CDKX/X last already And rationale patients progressed Great. question inhibitor? if palbociclib I that it VICTORIA trial. on given the my for a correctly understand to on

Brian Sullivan

rationale that. Boris, I'm there? sorry. of rationale, The sorry, out cut The you I Yes. mechanistic am

Boris Peaker

mechanistic given no, that's is asking I for Yes, what was what the [indiscernible]. rationale

Brian Sullivan

Sure.

fantastically prime done driven. is endocrine we solely was what that development that was cancer. to estrogen the was And better And cured. and to to patients inhibitors resistant and eventually of hypothesis and involved aren't XX these patients approved patients. cooperative estrogen mechanism that development of the the Work that the led one CDKX/X in to progress, beneficial think was become those obviously, well, discovered woman's be Patients these development. eventually to ago cell tumors proved with step drugs. years the are the these will disease therapies So back of cycle But focus were this will pathways. drug pathways these

research there's consensus over And I years there is. XX-XX reasonable recognition done think that the involved. And been a PIXK past to mTOR so is out understand mechanism has certainly the what that resistance pathway

response compelling the data, line apart to you from most of what marker. involved. setting, share on is about was can XX% that you we the even phase so with mTOR early XX% the a than when that had And we that trials, the non-comparative, inference rate palbociclib, XX% objective our second the early first study patients We been Again, that letrozole, [indiscernible] line palbociclib, data the mTOR we added PIXK the draw are progressed, that's we inferences. studied the drew have drew patients. lines, patients what population we of first that because showed for second are and And setting, some we reported this when you and pathway them though those CDKX/X And not reported was the induced, higher but PIXK then letrozole. involved to enough was the data, in registrational data has line rate numbers, In line those interpreted gedatolisib far the inference to results. palbociclib add that results we really in different in intrinsically

their that response data, when So progress response significant rate they even added endocrine had XX% received you X registrational reported in had was on reported palbociclib, fulvestrant, therapy, though that in CDKX/X the and response the rate. data XX% was only patients to [indiscernible] these trial, which a

differences saw this directly but versus the rate you rate these response between enough interesting XX% studies, are them, big to again, can't in So activity. again, two XX% compare be response suggesting

been you that in these proliferating. So resistant potentially continue reliance research tumors that, are would CDKX/X the to this tumor reactivate adapting that non-clinically, PiXK to to patients post has therapy. than a found data resistance received in prior androgen, you and primary instance, for reported allow that's that's to essentially, result we pathway, efficacy in treatments. in PIXK reported been become with done lower mechanism was CDKX/X reduction patients blockade everolimus become who has mTOR on The what think and which CDKX/X alpelisib progress in actually have treatments, the cell what patients and When pathway. could been hadn't the has is received That's means who mTOR are been CDKX/X is patients was then consistent that CDKX/X for that substantially additional turn alpelisib found with

non-clinical the will tumor to blockade pathways be which patients that mTOR in with they're so when these PIXK data CDKX/X means suggests there CDKX/X their And them sensitized therapy. cells will will will the turn pathway treatment be reactivated re

inhibition the you most believe of receptor kind what potential pathways had mTOR. what in line that essentially with that's now Estrogen line is first are involved pathways arms synchronized second simultaneously. So we arms. as consistent CDKX/X, the PIXK triad think of beneficial we And of And of is as well we data the all this those there's a of pathways treatment that our

equivalent case, now saying, in which on this maintain could potentially the effective the the think blockading mTOR we tumor a that PIXK or the the setting their that that's of in in this what and blockade drug where is be mechanism And pathway escape line strategy we that inhibitors resistance benefits intrinsically. disease that is And that's doing pathways that on extend with a pressure then put essentially get driving areas if prior the was route, proliferation. other may be we're the or these that tumor first essentially and pathway therapy the that from so we involved essentially, in treatment PIXK the benefit of can used fulvestrant and and this on patients can it's a the signaling clamp extend with cooperative palbociclib

Boris Peaker

you much answer the Thank my very to question. detailed for

Brian Sullivan

Sorry.

Boris Peaker

No appreciate very the much. detail. Great, thank you

Brian Sullivan

Okay.

You're welcome.

Operator

Thank you. The Gil Needham. next Blum is question from from we have

Brian Sullivan

Hey Gil.

Unidentified Analyst

is our taking yes. Hi, you for [Chen] for Gil, Hi, questions. thank this

regulatory the pathways under affect then perspective readout out out want just if to arm any gedatolisib it does we So offer other for if new misses, arms? and arm on the benefit for the ask any

Brian Sullivan

EMA in data a it's the your they would was the for as moving that fulvestrant We and rationale patients sufficient. recommended, be and arm for since recommendation thought not arm. the Well, arm. non-mutated really supplementing agreed EMA the think mutated by Thanks question. requests. address the surprised were had. helpful add to logical useful. the makes We for that that's We sense. Geta add with felt data forward so we We with population It

has there the no far arm has really test, hurdle formal that test, As that as achieve. to or

it's so And and that drugs to part individual treatment a you agency of see to benefit. different requirement demonstrate the the of contribution allow essentially

Unidentified Analyst

you. Thank

Operator

next [Operator Instructions] Hallum. Alex question Nowak Craig The from from is we have

Unidentified Analyst

is enrollment start for clinical talked everyone. afternoon, the I for good first quickly is team goals questions. guess those you And Connor can on Thanks numbers? sites thinking the do you dosing? are hitting how how about the team think taking uptake? trial modeling Alex. Great, any for and about This internal has enroll these enrollment Like, then there

Brian Sullivan

Sure.

in indicated, months. we to the few next the patient we've expect dose As first

So we think it's imminent.

sites, in variety As going. to a the activities of get are underway them

driving that events structured. ultimately And analysis. is rate patients, that how we're is when into sufficient plan account path rate we occurred. enrollment survival primary analysis takes available mutated patients towards trigger of have per it's arms as of number the second of events number or projecting the to and not, the 'XX As there's And far as think different towards, date that would enrollment, this between 'XX in the first analyzing. that as the progression enrollment, se, have much we're the allow that's is patients of population, we're again, for the less type that number about do comparison you half data of driving that of to number the that wild half you're population. statistical And of the free the It's in

Unidentified Analyst

Thank of as there kind up you. quick Perfect, like that additional ramp And just makes phase one. then sense. needs, three? kind you any Are staffing another of

Brian Sullivan

fantastic the support would short a to team are they've who general. we've period out team, job. They think, find senior of that I been doing So we're study, past And months, folks people specific perform such great built I'm of that a group built. built the over And in XX in in functions happy, time. has our operations say support the very able a I turn

folks And steam the in may but studies so expect forward. we VICTORIA-X going a working required increase full think the don't additional performing execute ahead. place and less functions, to dramatic team be senior more, there headcount in our We

Unidentified Analyst

progress. Yes, the Congrats Thanks on for update. the that's great.

Brian Sullivan

welcome. You're you. Thank

Operator

the reached of to our session. Sullivan call closing Thank we you. Brian back to would end I like Ladies Sir? for gentlemen the remarks. turn and have question-and-answer

Brian Sullivan

forward you attending to call. our will Thank goodbye. I look for to continuing We and update you say

Operator

you joining Thank conclude and Thank us. Ladies does you today's conference. gentlemen, for sir. that

your may now disconnect You lines.

Celcuity (CELC) 13 Aug 222022 Q2 Earnings call transcript