CELC - Earnings call transcript Q1 2020

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Operator

Good day, everyone, and welcome to the Celcuity Release of First Quarter 2020 Financial Results. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note this call will be recorded. [Operator Instructions] ] I'll now turn the program over to the Chief Financial Officer, Vicky Hahne. ahead. go Please now to is to the turn And CEO, my Brian over Celcuity's Sullivan. program it pleasure Please go ahead.

Vicky Hahne

section Thank on you, Celcuity's few XXXX us issued for today release Financial operator. the for press and minutes a for the you Good Results www.celcuity.com. be of ended our can our ago. afternoon, press everyone. first release our Today's discussion financial Highlights. quarter website a of Business First Investors announcing XXXX And Quarter found We thank results, joining XXst March

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

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

Brian Sullivan

patients projects, on discuss our The today, clinical Vicky, new and made comment on line an are development benefiting few from FACT cancer can proportion And use I'd of not things. founded product the therapy update, on molecular targeted the to focusing and of a medicine. for then, There's our patients, progress that of XX lack in an FACT reports us cancer and Vicky need, only questions. thus with that financial that I'm you, the for our unmet need. joined small status a molecular-based patient typically today mutation. an patients. roughly we'll biomarker, the over past their our guide, estimate, actionable a like XX% patients this advancements X who cancer pleased years, recent first And collaboration to for And in of me good this discussions to XX% targeted of a the cancer particular, address therapies. selection diagnostics for trials. our quarter a results. follow are quarter. Today X our will Celcuity We Thank open you results huge very unmet for everyone. afternoon eligible oncologist

a Our cancers. with which disease dysregulated signaling matching targeted cellular mechanism of patients oncogenic therapy's The CELsignia diagnoses is have underlying, platform, directly we diagnose a the many pathway activity dysregulated to a action. corresponds, that signaling mechanism driving

signaling business strategy for targeted molecular proprietary their is the tests for treat applications the our hard obtain to R&D patients strategy, Our of pharmaceutical to capability the working leverage CELsignia platform. to our strategy. for our To to Since can team execute platform we create identify. to a characterize, our new our expand help tests is therapies, companies dysregulated CELsignia too indications is complex

we can pursue. number number tests patients pharmaceutical expand New And the who may of potential positively the of impact. increase collaborations,

ovarian a We this we driven new to to includes estimated signaling. numerous test diagnose XX% which pathways development XX% the hope by to dysregulated and the pathways. and of is for to RAF/ERK patients, or target made significant XXXX. cancers that So by of quarter I'm RAS-involved PIXK/AKT signaling, developed RAS companies a progress of excited RAS contribute, drugs breast RAS have test, RAS developing dynamic CELsignia end to again of all report, complete Dysregulation cancer to cancers. signaling Pharmaceutical

However, found RAS that, two much important dysregulated different signaling, pathways RAS the interactions of play this involved. driven a extremely of research has signaling or signaling it because more RAS-regulated molecular pathways use has by are number made a patients RAS is less role tumors. tests RAS previously with magnified, cancer And network difficult to identify dysregulated between in challenge to typically Recent dysregulated mutations diagnosing than thought. also

development subset CELsignia is complexity it. receptor unique untangling, our therapy the particular, analyze leverages activity complex test treating signaling targeted pathways, GPCRs In or to tyrosine Our capable kinases of suited ability and uniquely multiple including our platform involving tumor to of combination pathway G-protein-couple RAS identifying nodes. of receptors this and

Our signaling CELsignia fourth, would our RAS dynamic test test. be

can working current new number targeted we drug significantly opportunity therapies would in their cancer expand patients c-MET PIXK efforts each companies CELsignia develop activity gain for molecular the patients successful offers of potential patients therapeutic to who those signaling could in increase approval HER-X-negative our percentage have HER-X, If a our to patients. by to of with tests, diagnose potential oncogenic new and and molecular indications. to undetectable the RAS options test identify, diagnosed test cancer could for one Since dynamic for pharmaceutical signaling cancer test the eligible the up indications, by to Our we're to current the successful, If signaling pharmaceutical significantly. expand tests patients. or companies benefit for a three, from CELsignia tests are breast a tests for obtain are

identify mid-May. abstracts Accepted by be call, a with our tumors originally Association until to the Annual subgroup in patients or oncogenic COVID-XX late June. we pandemic, have that new would activity. first AACR, report results which signaling cancer for presentations posted CELsignia of cancer for ovarian American at will Research last for for poster announced, was test ovarian we Cancer Meeting most will our late preclinical AACR AACR April. During the scheduled has hyperactive undiagnosed test new XXXX of rescheduled ours, including the Due This

advance a On the number for collaboration trial we clinical collaborations. continue to of potential with our discussions pharmaceutical front companies

we the pharmaceutical this events the clinical several sponsors still collaborations to by While some to delay these we year, these collaborations as finalizing potential with have XXXX. companies and expect past And affected most have companies varying may close been degrees year-end work COVID-XX of pandemic. have to

conducting successful, pharmaceutical targeted many cancer therapies Our us patients is if populations developments the clinical two on identified enable collaborations parties. and finalized, the some to three agents. breast test combination are sponsors. lead turn and And the agreements the companies study a reported either an the with research efficacy cancer mid-March on to industry since guidance the goal The delays drugs recent in trials. the related to that we could pursuing most our light and to In of partners country's like identifies. the four I'd COVID-XX the in the finalize therapies delays several evaluate clinical clinical cases is collaborations potential hospitals gain these CELsignia consistent treat the patients involve in collaboration ultimately issued we of These XXXX, single collaborations clinical by these of a of clinical in potential these collaborations, centers by required for focus Celcuity include our as well pandemic, those FDA's leading global relating updated trial to experiencing to our trail believe companies. the we're range of of tests. our significant patient of FDA trials. trials consistent now are helping virus ongoing or COVID-related to as fighting enrollment or healthcare would for in with to If approval between update the sponsor pharmaceutical time providers

remove we've sponsors, getting clinical tumors that are with cases. learned some cancerous to discussions during fact, even in delayed surgeries In

As later. interim we final until to and second delayed a half months now of approximately trials result, be from nine and results the XXXX results the the FACT-X expect FACT-X

COVID-XX updates But on now have as for course, Vicky? trials. appropriate. the financial We will we we'll of to the Vicky be and I'd can mitigate like results continue every taking to of you. pandemic evaluate the situation review step effects to the these provide

Vicky Hahne

Brian. you, Thank

or per share $X.XX press net losses Our include item, XXXX. was quarter. share adjusted for quarter loss or also non-GAAP for release the million of in Because net we compensation, our the quarter XXXX million per compared $X.XX first to net $X.XX first for loss include a a non-cash net stock-based quarterly loss these significant $X.XX

of R&D expenses to per $X.XX the was per XXXX Our or million increased the million primarily included quarter for non-GAAP to adjusted non-cash first million approximately of the XXXX. first a $X.XX adjusted was stock-based $X.XX $X.XX the which of non-GAAP increase of share million quarter first quarter XXXX expense, million XXXX. due a for loss during share $X.XX compared compensation. to loss of of This $X.XX net in net first or compared compensation quarter $X.XX

due other XXXX ended and during development validation and expenses million increased quarter the approximately million. non-cash G&A of We quarter stock-based quarter In payable and capital was compared activities for cash This $X.XX first net development attributable the working of first XXXX in of and to equivalents. a changes increase $X.X cash to business $X.XX to approximately assets operating studies prepaid loss million XXXX clinical addition, with The expense result $XX.X of million. quarter the million depreciation operational and laboratory million research $X.X $X.XX adjusted activities. in million offset of was non-GAAP in by of and net The of was and used first cash the of $X.XX accounts compensation.

Brian Sullivan

Vicky. you, Thank

we're We're discussion progress advancement for excited lines. and open please mitigate lines towards impact on the doing continued we up can the important to new time of Operator, closing and could our collaboration COVID-XX collaboration questions. trials the and everything CELsignia you So summary, agreements. in our any closely tests monitoring situation about

Operator

open. from we'll go Chen is Instructions] question Yi ahead, And Please [Operator our H.C. your line first with take Wainwright.

Edward Marks

on Chen taking behalf Well, and Wainright. of on from our the question. H.C. Yi Congrats this is Marks progress thanks for speaking

When enter just quarter? the clinical a test development trial progress the So, test a the first in to you in anticipate do PIXK signaling of following functional great point. your clarification the

Brian Sullivan

that's a good question. No,

as discussions quite these discussions fruition timing extensive. the we of found getting started we to So, is

investigators And and so we've different begun with companies. pharmaceutical discussions

But from is would typically initial if on announce a the hard -- to XX history We get that. a a time put expect months take to it guide, we data. XX date would we haven't collaboration

Edward Marks

the update. All right. for you Thank

Brian Sullivan

You're welcome.

Operator

We'll Per take question Craig-Hallum. your line open. Ostlund with our next ahead, go from is Please

Per Ostlund

Brian and Vicky. Good you. Thank afternoon

Brian Sullivan

Hi Per.

Per Ostlund

follow-up Brian. to going on the question. I'm previous Hi

that population as dysregulation and sounds I you signaling help within the guess uncover that to successful one a that mentioned RAS you're nicely sized of like test the patient And in cited PIXK and regard. working you're that RAS can it You develop underlying pathways targeting. you you're if signaling

that expect available? like or Given test it success trial a Would is a when you would find stand-alone -- RAS word is unified sounds you that lack PIXK collaboration, a you for of of more expect a better might PIXK CELsignia RAS. subset

Brian Sullivan

that's bit a involved great And of there's a that. of kind biology No, question. in

is then ERK. RAF and the important MAPK PIXK. So, nodes of are pathways and PIXK, those different pathways MEK two network and RAS signaling and that within includes comprised And AKT,

of nodes we So developing how targets. could it, the that of we go revealed survive. other these all us RAS kind of, part were are proliferation about untangling either tests, potential how PIXK our all involved network. long completed or are we they work cells signaling supporting They're can in to this drug And when

involve subset what pathways call will one disease HER of which opposed akin we targets tests so to to RAS-involved c-MET found we the multiple other think them cancer. cooperation as the we up invariably RAS because case, RAS layer In But in cooperate. because it overall, And are several as refer subtests complexity. PIXK that receptor when ultimately we And this to situation drugs the consider that a will and is probably will family treat of signaling signaling or would might with these RAS-related would within to involvement are the tests. another you network a intracellular extracellular be And subsets these the within require ultimately somewhat we patients mechanism targets the with I family of adds then with pathway. identify discovered say we in end working of I

Per Ostlund

test actually of Okay. answer because sensing as follow-up That the your kind there c-MET parallel sense. makes was had captured developed I And a you a well. to that

with of would for We're preemptively would that's answering that Do c-MET kind to the the on thank So, at sort c-MET sitting in you XX-month question. you nearest this PIXK. expect for expect next at of my you of collaboration sort a this we collaboration time -- around XX On level out line you that mentioned point. point?

Brian Sullivan

-- that like c-MET case we it's stages those And this say stages. at would similar that would among children. I these include amongst it's think call I my several in They're similar are that drug. -- are have ones at

Per Ostlund

Okay, one in me. collaborations into during then all are what thinking your the clinical of this and kind probably activities comments. addressed a it people COVID-XX last And that had right. That question makes And come pandemic. sense. as today for you press potential chill to at release little bit of and on in had do put expecting I about trial

lot that there going level bigger a events engagement to be pertains that any from kind As partners level, or are potential it or at of engagement some of AACR, virtual, you you gotten of having these a isn't that remotely sense when hurdle pharma it like to to and to clinical more different research where have do there is still industry seeing things like or same there's that? collaborations of events overcome sensing bigger face-to-face on do

Brian Sullivan

a good That's Yes. question.

opposite. can I work think actually it the

and having think for calls a allows back on quickly to screen and presentations forth. it and reviewing Zoom adapted people efficient I to easy and shared have they're

in engaging this folks we've been successful of been obviously visiting pretty traveling folks. environment. kind and We So haven't in

we're that one targeting meet AACR that people deliberate to But about the those run people, of And wouldn't like you sites us line focused so pretty which other think with we're I we having they'd be the how might conferences hopeful benefits we're is otherwise discussions in the to with. meet. how won't is that a who groups maybe into give with even chance that centers have collaborate have we're pretty And focused we'd on to of though sites pretty of within and network that target we number a terms with. relationships up and we of

So -- but that, things sure live able advance like meet equal, we're plugging the at still being all collaboration. people conference it's better it's and a away to to

senior they're of though effect the with I COVID-XX think that is we're are leaders doctors working where biggest the the that of survey. in many institutions

And involved are so around developing health of their kind they larger and protocols in issues COVID-XX systems. care

do which But either. and away time make is from that trying them And doesn't what so we're just takes away to understandable. -- it go

of you So of We of the us at COVID-XX. are kind that of backdrop them. on we're been was vis-à-vis the was us different the everything patients. that with I lesion But other risk for patients, knew infection about delayed read say guess to the to for do has it's that as impacted burdened cancer is just was a least a much trials lot the let's remove, regardless, I many down surprising are and general fact not potentially of they delayed procedures have with it and mean considered treatment world. thing system than being mean cancer to surgeries cancer and to whether was surprising care probably impacted has spared would no it and But cancer the does evaluating drugs trials in elective slowed patients that that what health surgery. the I impact be has as been for these

March, the early you affecting I in health but if corner question the had would me thought, As probably pretty asked have much every of market. clearly it's care

Per Ostlund

Definitely That’s a it. Brian. I situation. Thank has. definitely Appreciate It all you, had. fluid

Brian Sullivan

you, Okay. Per. Thank

Operator

[Operator Instructions]

Brian Sullivan

appreciate our to in months forward in everybody. with I of we'll and call your absence now. three We think release into you Goodbye. communicating questions, listening from Well really the further look

Operator

may participation and you program. This disconnect. now today's Thank does for you your conclude

Celcuity (CELC) 8 May 202020 Q1 Earnings call transcript