CELC - Earnings call transcript Q3 2021

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Operator

Greetings, and welcome to the Celcuity Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to Robert Uhl with ICR Westwicke. you. Thank

begin. may You

Robert Uhl

Celcuity Good press financial and webcast results you the September of Earlier call. Operator. the section results third quarter Investors can third and to be quarter Thank ended today, us. joining XXXX and XXXX. for website. released afternoon, you, financial welcome for The everyone, XX, Celcuity’s conference incorporated release Thank our business on update found

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

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

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

Brian Sullivan

today. Thank joining you, thank afternoon, everyone, you Good us Robert. and for

status activities. will of your an discussion our we'll our program development quarter our call, then comments up the questions. line and appreciate companion my update with of gedatolisib the Celcuity. update always, third Vicky As diagnostic financial follow continued results, on a you financial results, clinical open we support on for and On we'll our this of CELsignia

efficaciously a you when this April may we PIXK/mTOR PIXK/mTOR know, that licensed PIXK/mTOR pan because tumor As in took its types, because different structural significant plays Celcuity to cell from central tumor reflects inhibitor types. for Pfizer. for active key took of in many many a blockading role patients and most with of pan transformational potential PIXK/mTOR the step outcomes improve This the though to signaling of complexity safely well-tolerated metabolic year, is processes. this development step proliferation inhibitor offers the linkage potential and We challenging, its the of gedatolisib

targeting realize very has a specific Thus, PIXK/mTOR critical the the not PIXK/mTOR believe believe therapies tolerate. uniquely when cancer significant to against we is isoform first with that approach five to potency inhibitors. first optimal subunits, gedatolisib’s all PIXK profile discovered. that PIXK that combines gedatolisib compares resulted in positioned in safety drugs doing until requires subunits was for potential envision favorably role We inhibitor inhibiting high gedatolisib the against so the While development different five patients could was approved pathways

would receive to or over patients with We’re advanced XXX,XXX potentially We metastatic eligible globally be gedatolisib breast breast if approved. gedatolisib cancer positive negative that currently developing treat patients to cancer. HERX ER estimate

tumor a broad role, demonstrated types. Given range play to of been broad the has signaling PIXK/mTOR in

have additional we We to substantial breast of outside opportunity also indications believe a cancer. develop

responsibilities schedule. for to gedatolisib During and Celcuity the regulatory, quarter, trial we of Pfizer ahead completed the clinical of reporting transfer from safety

to trial and principal an are inhibitor the presenter. in Xb a different breast the during sites Spotlight who the continuing an clinical Ibrance the participating gedatolisib Rachel of Cancer San Center be oncologist who a trial be with clinical with gedatolisib This at patients XX from the was will For the working will for to Session Dr. now data cancer Anderson transition Antonio for CDKX/X December updated our clinical that treatment trial, combination Breast protocol. clinical ongoing presented two evaluating updated at patients MD Layman, pleased trial, ongoing the Poster our Xb therapies. clinical trial on very XXXX. Endocrine Phase to ongoing we're is receive Phase Symposium Discussion Cancer Texas XX, University a investigator We're

process palbociclib breast preparations cancer patients engaged with and trial in underway. CRO evaluating and our commitments are fulvestrant, recognized to Phase critical as an and identification a gedatolisib globally number site initiate clinical KOLs started to therapy the of cancer from the is received We serve of breast trials committee. qualification vendors well X and which combination other steering Endocrine in Our a members advanced with had of

expect is feedback, to in clinical activate FDA the XXXX. continue first to of their subject and Our trial scheduled we to half this the meeting with

began inhibitors assessment also microenvironment previous evaluation of gedatolisib. may for for review prioritizing of We trials indications tumor evidence of pathways other that related cooperate to non-clinical with factors evaluating clinical identification potential activity This PIXK includes and and PIXK/mTOR new and PIXK/mTOR. of and mTOR

XXXX in gedatolisib. that plans development develop to first plan guide half for a will our long-term is goal of Our the lifecycle

results efforts. studied using action, CELsignia inhibitor meeting valuable and in drug annual development mTOR us tumors we've these with development mechanism studies evaluate using gedatolisib platform is the pursuing different CELsignia evaluate gedatolisib at The PIXK As lifecycle our breast insights of that additional in a as collaboration gain AACR to CELsignia interest the opportunities, platform. the study to initial of our of ovarian about past to about we in inhibitors assessment patient We this Pfizer April. PIXK part us value presented leveraging a our demonstrated our planning our and subsequent to due conducted on and discussed, our of to platform, part initially of previously internal studies gedatolisib’s approach of our let diligence

We are indications platform additional using our investigations gedatolisib. CELsignia our for assessment to of support conducting different

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

matching be in for too to therapy identified. dysregulated cases, for who lack our a platform molecular patients most options is molecular can that tests identify So treatment targeted complex Since biomarkers. characterize signaling can actionable new

XX selected cancer results The number unmet patient CELsignia HERX is HERX to indication evaluate clinical brain is challenging and Enrollment is this, companies therapy. trials current a stage To anti-HERX them. to to Puma six Our a a targeted trial metastasis. the test. response lead drug to breast are to HERX activity that selected a advancement Celcuity the to expect ongoing inhibitor, is rate may to with chemotherapy, conducting diagnostics months collaborations new and patient new Biotechnology. of trial interim Phase or patient of trial medical us XX will need. have demonstrate Cancer populations Celcuity with negative Center we're breast less activity to than for open-label previously collaboration mid-XXXX. a in metastatic Patients clinical patients pathological first cancer evaluating pharmaceutical the These efficacy by obtain brain of HERX CELsignia complete patients a the population trials anti-HERX are tests of evaluate be CELsignia study pathway with cancer achieve the efficacy Celcuity by these neoadjuvant treated drug patients. tests This now who safety metastatic months their with results pathway Rochester obtain breast metastasis, final of of This and allow neoadjuvant treatment market FACT-X But eligible to neratinib, October, collaborating their in pan-HER a In enrollment therapies complete of in have X treatment University company with needed expand capecitabine, Puma's breast collaboration and may for identified followed our in early Celcuity the activity patients Wilmot strategy of results by and care by we're an and identify pathological later. who patients on to treatment of therapy. expands the initiation response hopeful We will to develop cancer therapies higher or collaborations to to the each goal CELsignia receive negative that much place. chemotherapies. NERLYNX estimates with favorable. enable targeted planned companion clinical to recur. The of receive options of XX from Based into rates, begin trial our that cancer XX have The trial FACT-X their entered targeted pharmaceutical standard after likely

most So cancer let of and with in hospitals CELsignia were both of trials a related the results the of the by as breast half that quarter step COVID-XX XXXX. to patients. third Enrollment We negatively can of Nevertheless, delays of prominent we such activities, research collaborations though COVID-XX extending believe This later screening interim FACT-X some trials lives previous a period, reduce our in about which expectation especially XXXX. interim play Hospitalizations trial during we're FACT-X and will with increased second results during work dramatically the related role cancer opportunity in tests impacted is world's the to in first this our require many in these than excited of patients from FACT-X clinical the CELsignia. quarter. and FACT-X expect significant now those centers. the

goal We coming have our new is agreements discussions progress, announce the additional and to in collaborations in months.

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

Vicky Hahne

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

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

The The net – related and I trials, the for with cost cash cash legal consulting stock-based related increase approximately compared preparations approximate fees in associated of $XX.X offset million during clinical of will to compared working activity loss increase. in activities. changes was December clinical and increase gedatolisib. was $X for including third expenses, quarter of result on hand quarter compared of related the XXXX. million million for the gedatolisib $X $X.X million Employee-related is million with of G&A of adjusted quarter the $X for compensation. of remaining non-GAAP by equivalents XXXX of patents of quarter the arose the ended expenses quarter equivalents call increased depreciation used the XX, patent million the quarter expense. million $X.X compared to to This XXXX. cash the Our adjusted non-GAAP of the of XXXX, of from adjusted million XXXX. This operating in of to of $X.XX activities cash of million third XXXX, million quarter XXXX. non-GAAP and and net Brian. We Net $X.X share to third to R&D per approximately compared XXXX $X.X loss of third third loss now per during the to was the for quarter the expenses $X.XX $XX.X cash $X third quarter $X.X or third million or $X.X capital net for share back accounted third of the increasing XXXX result to was of non-cash million to of million primarily the related $X.X fees transfer

Brian Sullivan

on our the capital studies Operator, new I'm for gedatolisib you, shareholders Thank cancer opportunity forward made of are We're throughout this the lives feedback expands potential we we markets can I’m the looking we and have progress FDA's X The to develop the about XXXX. trial significantly getting very extend addressing, Phase and expect of The of can Overall, the activities for our to the create the side us design we quarter with now the and Vicky. to patients. to the our value provide advance our soon the activate to call CELsignia in to financing while diagnostic groundwork also advancement trial. finally, programs. our significant for platform, ready further continuing company to XXXX, questions. development open lay supports on successful we the the impact

Operator

of Instructions] comes the with you. Thank [Operator Jefferies. first Our Please with question your from questions. Maury line proceed Raycroft

Kenny Chan

Cancer Breast have of from poster? I that San is Raycroft. Maury expect question Antonio This Chan about terms and the data. What for in Conference Kenny we a on efficacy follow-up should

Brian Sullivan

Sure.

was that for January, again of represent patient that data So detail and will the additional analysis this data performed data previous characteristics were which caught We'll on was also some May include has analysis reviewed cut. of integrity. versus better, additional data or as been that duration exploratory treatment, cleaned data

what So study it'll described, with aspects just we've of essentially into be dive deeper consistent the patients. and the certain but

Kenny Chan

have trial more one Phase X design. And I Thanks. question follow-up about

Is will you patients first line baseline, you screening three screening patients time months? CDK months by CDK who be patient for it with – or Like, who fail perform are CDKX/X five Regarding better? within for to how failure?

Brian Sullivan

Sure.

But will we details to. our past. can when to trial because going bit those about of be we're in I characteristics design eligibility be of screening requirements into and this quite a talked of we'll generally, detail that the we'll So speak types ready speak announce and the

who is or so to to arms quickly prior proportionate treatments study. arms. your may we subsequent treatment. could your you patients ones stratify There have plan equal different that you enroll there's have CDK also can ensure progressed representation that progressed ensure representation be factors on across as enroll that in Our for are on And well the study

consistency we'll the to talk those example similar variable provide design. that to could be some time schedule used our described variables of across when So stratification are one to ensure about would you that be details But arms. trial we your an a

Kenny Chan

Thanks.

Operator

Thank you.

your with with come from questions Cowen. proceed next line Boris Please questions. of Peaker Our the

Boris Peaker

Great.

the I'm for on what logistics suited and types just tumor for a type and of sufficient are work folks would – how CELsignia physicians some Just test, what tumor curious painting sample? patients best

Brian Sullivan

Sure.

the focus These with trials stage our FACT-X patients. with women is the breast. The now tumor are patients. cancer presenting who are in two working and are right breast So FACT-X early

biopsy. initial for of additional tumors time they would lot hope In we available CELsignia. good and to an have that we initial But in get initial a we very biopsy, so available diagnostic will that tissue accessible, be a at that, the clinic, their – if, to or the undergo biopsies diagnostic future, biopsies And receiving moving patient So to they diagnosis. we to their but of get the is expect very think using in the an process. case study, purpose our typically the we've it's that's the something when of tissue have pieces through there's rather evaluate worked

those at So lot you're can false results, And be have of that with a we available. time provide our a would not we And stratifying doing actually patients studies results negative the later prevalence process. that malignancy. standard patients. don't women stage would to so to that In the those the diagnostic then we the ways generating clinicians results results patients, there's for of of receive. who testing, stage of genomic later the care should inform much providing decision treatment a the settings, follow similar be more about of become is type have because Biopsy of

days. biopsies result in as is, or cancer most an we are lesions, be in we've so breast on report just out receive those less XX based And the think and example, are average obtained typically we a from tissue than site cases, liver And and primary common would metastatic what on but lung, so seen lesions would far. again, liver

Boris Peaker

you. Got

you lastly, what's any need for the for X maybe exactly studies, pathway so to And approval comments regulatory the and there? and that FACT-X what show

Brian Sullivan

Sure.

that's the us – significantly basically received the woman that of selected are the to response. a get essentially or pathological tumor. treatment complete of you detect So stage. And response higher complete who proportion who designed are that patients whether goal have patients before will means to eliminated they early studies PCR allow Pathological achieving we've

cancer node. So the of local the it the to their or increase woman's the tumors breast, or is spread spread will it's lymph just hasn't the in that the recur. goal decrease – that beyond likelihood treatment And

we would regulatory expansion either and pathway – case to regulatory let's about for talks able from approvals kind their that FACT-X point at and with say, new with the specific with of of who our Genentech a standpoint the what are collaborate whomever of a with label drug of ones drug in the or the regulators driving would example. would we if And sponsor and be conducted then label forward expansions So demonstrate an evaluation be regular would PMA about the diagnostic, moving that, They discussions as be would to would trials activities be companion and is, concurrent then that bus. it's Genentech, kind kind expect There's be parallel. approvals. in our driving guidance

And depending of that we or regulatory pathway step. within patients. cancer operate would that on assessed of would is, that And take could to help the ultimately FDA require, additional what maybe available data with their kind decisions these ultimately would then inform treatment to breast the so a framework. we next oncologist And for goal that being be the

Boris Peaker

Great. for Thank much question. you very my taking

Brian Sullivan

You're welcome.

Operator

next Instructions] your of Please Alex [Operator proceed questions. Our Nowak the from Craig-Hallum. you. with Thank line with questions come

Alex Nowak

everyone. good questions and Brian, XXXX? of data. sent Phase Great, key change feedback of could I And for the potentially the to first X afternoon, a some of pivotal the that just do the could was hoping for feedback any your think highlight you plans you over FDA you in launching half

Brian Sullivan

those questions, yes, fax over Well, I'll Alex. you

Alex Nowak

great. would Thank you. That be

Brian Sullivan

closely FDA matter kind of into topics No, I'm the have subject sure, of that divided appreciate you'd and the different Yes. meeting related the are is areas. you that. typically goal No because

clinical the trial And input case, matter design. guidance wanted who experts bring our we subject to so on and in provide would

And study different cancer on what thinking to of We provided the series that the the the take of what a we in proposing. presented. KOLs of discussion. so which breast approach summer scientific these to were good And over We consistent pretty actual KOLs whether proposing options. the a advisory review time spur there was. our X lot X data Phase we've made to also consensus design. Phase relate spent to that And we've was meetings to or shown found our was that we're during with we with discuss, And we wanted design the then specifically sense, questions

would our or was it be approach. that oncologists were right us encouraging what to was with thinking the So consistent these approach suggesting

make They that – is an we that consider goal to details there's really people want approach arm endpoints, challenge. that accept potentially the biggest reviewed have sure example, other to a you're that data. would make a one in that That represents as the we could into that protocols, which variables Our will of comparator stratification lead means that our these take results. it these you lead you meet you realistic. any to factors, appropriate has to go assuming, that into robust detail eliminating develop And confound study with account biases the then your lot have just And so investigators investigators. is real-world and activity is a

types about and And with of a that's the document information involves very provided and providing so – the process FDA. trial questions. then those specific the design information to background are the information, The the then type of we detailed

suggest will necessary, memorialization a then that the of review and receive and a end the them in kind those if so and modifications. this FDA We'll form process process And itself, from conversation come the discussion. of then those and involves to meeting of a The questions. change the by review or of them minutes to we'll have minutes

to not at it's So to of a our get it's but of an – a this bit stage this input. process ordeal, certainly a of development bit

feedback. timeline, we're kept, part. of as of process a haven’t you we're different structured allow standard new And meetings to And to which be are are on some and that which their sponsor, aren't get basically starting, certainly, a there Now, But it's some meeting aware would those. approach used of feedback. of kind of very positioning get ourselves with advantage take a to programs And expedited those.

we've point. way input need. only think a the we on the effectively we really really to received. that's with But think very the We the feel based interact it'll we at input up. us this about good good so give we approach consistent ended again, have where and And And – agency get

Alex Nowak

a to No, back ago, that's going not a couple would I remember whether bridge need questions, helpful. a Phase or And was you run quarters X. there

confident move pretty you're this study. So directly can pivotal a into

want get that? Just your on to thoughts

Brian Sullivan

So questions like that.

go or you So that involve to X the to really safety. two X One issues Phase Phase X, factors. that Phase to is surround, whether Phase X

So say or that generated data the been into data the a The go how don't for much drug. depending study you characterize safety. on registrational agency have has to enough could to

Gedatolisib a though XXX do what signals the to to nearly need been over or studied flush You Phase further patients. is study in X has out are. safety

a of the drug Phase combinations, enrolled different So XXX patients. Xb over variety

opinion, pretty events I clinic, would So our opinion in the safety investigators. its adverse the it's – say been of and profile the – we would well the use favorable, no has And pretty in with would in argue established. well limit

So that's what sponsored factor relates to with the second factor. would spots they Then risk. call one

bigger favorable not have on design X, they so Phase the And the right were have going with prevalent more to X are a how studies designs see Phase become study look study cases, the to X sufficient if Phase where they Phase to safety of to And many justify option in more at then data it's a studies you'll today, you much to patients. go X. or depending

endpoint kind And so the data an where significant would is this up of clinically and relevant is for be a of we to margin statistically that a certain believe approval. case, safety meet creates

Phase means to to couple call X, Phase makes going program. X, essentially warrants, X the time, Phase use that that. through just of if years the the option balance of add – decision. you want that with agency it we because the moving additional if of And moving directly more essentially, it, sense the when it to you program going as a the and it's of think It time our we so well, risk, quickly, the and And is believe your makes you to to advantage expense

Alex Nowak

sense. makes That Yes.

And Okay. you of couple maybe Got here. just the months tracking FACT-X FACT-X, interest could studies, makes next with Brian. That that on expand originally sense, data delays it.

Brian Sullivan

the change. No, world I Interesting. mean,

for If of look I'm hospitalization those and go and I look many you sure guys you COVID, I at you data the the charts. back curves. at at mean, do, look

you if they third almost bothersome. of immediately. at Now, were look first, then a And to them then that that climbing weeks week they of levels week later and started bought and getting were July out July, second few By were early August, they troublesome. that

of patients trial for not assigned people have trials want extra the what be. obviously typically found And been And assigned to we our where, simply is clinical centers an infectious so the environment b, a, hospitals labor where staff COVID is you requires the patients to elsewhere. very which a patients, management have of who who cancer to with in people to in disease, because that come are intensive, the get are biopsy procedure,

And intents all are and when them to them enroll so in least, individuals' studies need there's we And that's you had at to very these simply, not that XXXX. or ramp what sudden And anywhere. It this beginning is experienced caught patients everybody in these took screen to monitors was They're and a and experience the consented start just purposes we August. stop, and study. the get because hospitalizations for available.

through isn't were it. I we what COVID, happened. waving July we worst think ultimately was And thinking goodbye were of in the but So that everybody to

Alex Nowak

the Yes. sense. Thank That update. you. makes Appreciate

Brian Sullivan

You're welcome.

Operator

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

Brian Sullivan

our to the call. later. company. you in interest the Thank to you We updating appreciate future. you forward for in Goodbye. attending Look your Talk

Operator

today's your conclude does This teleconference. participation. We appreciate

at may a disconnect great day. You Have time. your this lines

Celcuity (CELC) 9 Nov 212021 Q3 Earnings call transcript