CELC - Earnings call transcript Q2 2020

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Operator

Good day, everyone, and welcome to today’s Celcuity Release of the Second 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 today’s call may be recorded. Instructions]. [Operator my Vicky today’s Hahne. now Brian over to and Sullivan pleasure is conference turn to It Please ahead. go

Vicky Hahne

section Thank on you, Celcuity's few XXXX operator. issued for for release financial joining the Good press and minutes a afternoon, the everyone, today results site, be www.celcuity.com. of ended our can a ago. and press for second release our Today's discussion financial highlights. quarter Web a of business second Investors announcing XXXX us quarter found We thank results you XX, June

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

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

Brian Sullivan

development then comment status will for and Vicky, FACT-X I'm focusing our follow pleased me the line many open cellular pathways us good of us CELsignia targeted quarter. in the and to our particular product our quarter that and joined pathway questions. trials. our and this dysregulated drives past you our has to today with collaboration that this identifies tumor financial update Xrd you, Vicky projects, discussions on treatable on progress results, and diagnose diagnostic matching afternoon, discuss allows in I’ll a Celcuity a we our platform FACT-X signaling the cancers on underlying really an activity, generation will disease second first dysregulated therapy. for a Thank patient's that results mechanism everyone. clinical signaling

additional second development to our CELsignia Activity the or during In To of CELsignia results Association tests Pathway we June, tests therapies advance for execute AACR, test quarter. obtain platform strategy, cancer can new we treat model. to capability Our strategy the to pharmaceutical tests molecular targeted patients create our of business Cancer is the leverage Research, American continue for their indications at complex studies our dysregulated we help first ovarian Activity is signaling characterize, companies the for of presented to proprietary annual our meeting. to too CELsignia identify. Pathway for from a CELsignia Since

benefit patients the is which Only most ovarian CELsignia Our since XX% in molecular-based past made women XX,XXX today have signaling. patients typically small ovarian year than of a cancer years from a c-Met from options identify a patients portion test an abnormal a by need new whose many less cancer subset mutations. our actionable CELsignia die that’s cases XX helping drug to HERX cancer. Nearly with survival lack who significant companies also identified precluded ovarian that that pharmaceutical identifies molecular new ovarian receiving test. treat ovarian undiagnosed drivers for of by for It test in abnormal a over the obtain patients driver cancer cancer rate. intended need coincident whose indications a address signaling to five-year cancer, is treat can patients are from disease ovarian biomarker, a unmet this for cancer advancements has CELsignia tumors actionable unmet cancer to is are lack an cancer which molecular mutation. These medicine patients optimal is treatment a diagnostic their the approach have and

to year-end discussions presents. the first two then Regarding progressed companies additional confident. and XXXX. We the ones finalize of COVID-XX our collaborations collaborations, despite pharmaceutical half headwinds with We’ll remain quarter, before during very the in our one

to several these A cancer the single as pharmaceutical for efficacy step Our potential in patient research towards are collaboration new a either otherwise a targeted global company CELsignia And therapies. evaluate able enable partners of to include populations. These critical the as obtaining companies. our collaborations represent identifies. finalize, intended If to therapies a combination not their indication potential or range the leading would in patient evaluated centers were these study collaborations would be country’s to successful, these well us collaborations test a pharmaceutical of drugs targeted populations drugs of many evaluate agents.

although our COVID-XX impacted restart see and sites activities. by their clinical FACT-X delays, Finally, we many somewhat FACT-X related trial trials remain

the adjuvant can patients. therapies to response continue Both cancer patients. the breast each HERX-negative less play likely complete our trial significant a trials We're pathological interim our pathological FACT-X of treatment test in and test, is CELsignia extending goal than to adjuvant a CELsignia to by receive as life that hopeful obtain of rate identify patients the drug in new last The anti-HERX call higher the early-stage role anti-HERX cancer second have cancer breast Since recur. evaluating Pathway we many a are from half results breast Activity to to new of treatment cancer therapies. a current We HERX these reported demonstrate who FACT-X in drug expect of trials response complete patients cancer XXXX.

review financial will Vicky back to who results. like to our I’d So now turn

Vicky Hahne

per XXXX million $X.XX per net or or X.XX X.X quarter the second to share $X.XX per Because the share to million X.XX stock-based included second million the loss loss period the include in or for were also significant for our Net share same six months release X.XX compared non-GAAP quarter. which or of compensation, compared a these we XXXX. $X.XX year loss press Our non-cash was losses net quarter is for in net first share net quarterly item, XXXX. million of loss per the adjusted $X.XX for

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

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

Brian Sullivan

Thank you, Vicky.

CELsignia types the presented two tests pleased progress in So two tumor making. for We’ve past we’re summary, we’re the data in months. over nine different with new

discussions Our and to some this pharmaceutical year. to and clinical with expect collaborations sponsors close we advance continued companies

the obtain CELsignia from to confident X interim patients for of we the to XXXX. in would Operator, and We XXXX. results breast for take now questions. And FACT-X test half data present another remain of cancer we’ll expect second that we by trials end like

Operator

Wainwright. question And Instructions]. go first Chen Yi with take ahead. Please our H.C. [Operator we’ll from

Boobalan Pachaiyappan

Hi. dialing Yi Chen. for This in is Boobalan

got I’ve of questions. couple So a

one, you the new the mentioned first about trial So clinical collaboration.

expected So do you be later many be are year happen this to focused and to it will collaborations such know cancer? how ovarian on

Brian Sullivan

thanks question. So your for

two that we’re would of towards to near cancer. term for just expect next fruition those to collaborations year. be cancer and additional now be won’t one probably or on in expect ovarian began to would then that Discussions working end for the We breast expect XXXX. ones collaborations year collaborations and we to come we until this half year first several announce The to next announced the

Boobalan Pachaiyappan

expect for you your That’s upfront Yes. such do really any payment And from collaborations? helpful. partners

Brian Sullivan

those finalized. collaborations they’re We’re not until going to characterize

announce at able So we the we’ll to describe those time in them, be detail.

Boobalan Pachaiyappan

for the trials [ph] start? may those Duration clinical when

Brian Sullivan

I’m sorry.

Is collaboration? that talking about? what you’re the For

Boobalan Pachaiyappan

Yes.

Brian Sullivan

as [indiscernible] work an time getting reach agreement to to fair when study may know, Well, of conduct you approval a amount you IRB there’s from of the a drug the supply.

there announce an months each ready. depends six their be time collaboration. again, processes, to of a enrollment can And you And so you’re specific and be agreement that when on from particular nine but will partner time it the actually to to

Boobalan Pachaiyappan

patients amid trials, the And helpful. FACT-X that’s pandemic? Okay, on FACT-X enrolling and still

Brian Sullivan

there was when period trial and shutdown After activity. admitting roughly who end quarter the second COVID-XX of their weren’t the the But both patients a sites most quarter, yes. the the most were part not of clinical of for

Boobalan Pachaiyappan

validation the CELsignia from question release test? final one And When Okay. for do expect RAS results you to essay me.

Brian Sullivan

data towards of So to additional our we round be goal. the provide expect next current – That’s year. of to this end the be data able would

Operator

next our Please We’ll question Instructions]. ahead. Alex [Operator from Nowak. take go

William Fafinski

for actually everyone. for questions. Great. afternoon, Alex. Thanks Will This our is taking on Fafinski Good

in into First the just the trials progressed summer of enrollment far look effectively me, and discuss how just with with the FACT from things provide QX? you pace Thanks. thus could this us

Brian Sullivan

Right.

of location-specific sites know reinitiate to of saw I a of were really would either and more say activities. not line. the QX, states I think means as there an So back site-specific, been I begin of which want the June, sites sites or – were caused necessarily our don’t up activity. would the that and July sites was There’s to in most getting And on it to some but end curtail – pause, you some just say uptick we some in enrolling say was I to

I before. the expect been would maybe COVID-XX, the I would trend as you the But the some might maintaining unless back So and and really activity end that along again we would the reengaged, for way. of problem say some with bumps But say there’s suggest upward have other second sites this our still current – half and most has that’s a there trajectory expect we’re would lot but but results guidance full of by quarter of be unknowns, 'XX to certainly I

William Fafinski

Got I of was FACT-X, And That’s thus targeted helpful We diagnoses color actually there. less then the FACT-X. getting it. prevalence impacted just the appreciate how one patients reduction cancer in wondering very for were screened you. in me. cancer

Just your this are in impacts beyond? how on and thoughts what QX enrollment

Brian Sullivan

too about to hate get would I that. precise

that You scheduled that out that. don’t the and in number procedures. get patients forecast in may want to blip reports have a lead being I because general of like QX? for read, business weren’t trying something declined in cancer second Does to some of the in diagnoses there to been quarter have biopsies diagnostic the

that the that enough of I that. think projecting suggesting areas aware some – experience get and much hard in will system, what that a in the noise backlog of to at in or have that directly. there’s fact I’m don’t not we’re that it’s people there’s precisely. translate But off doing the We comfortable I’m so nature to forecast of least maybe some to

William Fafinski

and best forward. Understood. of questions moving Thanks for luck taking the

Brian Sullivan

you. care. Take Thank

Operator

Instructions]. [Operator

Brian Sullivan

Okay.

So we other questions, – questions think the I any in unless have queue. other

Operator

the no there further No, on are at this line questions time.

Brian Sullivan

and the with Okay. quarter. you forward to Thank Take you call appreciate care. speaking next attending you everyone. look very I much,

Operator

This for does participation. you Thank program. your conclude today’s

You may now disconnect.

Celcuity (CELC) 10 Aug 202020 Q2 Earnings call transcript