Celldex Therapeutics (CLDX) 7 Mar 192018 Q4 Earnings call transcript

Good day, ladies and gentlemen. And welcome to the Celldex Therapeutics Year End 2018 Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this call is being recorded. to Vice host President like Sarah today's now Senior Cavanaugh, of would introduce for your conference, I Corporate Affairs. begin. may you Ma'am,

Thank President, today Vice Financial thank me and Celldex; Martin, Dr. President, you. Senior joining Co-Founder, of Scientific Good With Executive Officer. Officer; Keler, us. Sam Vice and you CEO Chief on Chief Anthony President are for call and Tibor Marucci, and Co-Founder, the afternoon and

those that and Management's on will in current to press Celldex's Before statements respect forward-looking actual be expressed to headings we cautionary X-K, are speakers our results on cause reports and materially include Operation that the in XX-K, set annual under Analysis begin risks statements and XX-Q, of on Condition reports quarterly and to and such with forward-looking Celldex's Financial to from Certain assumptions on Form by differ cause subject SEC those as differ factors materially and making Discussion the Results All like forth statements. well and Form results described or Such report could views mention releases. reflect notice. might Celldex's I'd their Factors qualified entirety its events other by statements with are Risk based the implied as expressly in from those statements. on forward-looking filings uncertainties and those Form its of today's this actual forward-looking discussion, that in current future the to of

end other Celldex and aware on factors statements be the now call. assumptions estimates factors differences. will are plans, the any of be the underlying like in held be and based to call does over review changes that be of may this that at as advised the These You all these events, I'd should promise changes. information, update carefully these there forward-looking and not reflect of future factors, could or and information, to statements answer to Anthony. question or call, cause that other new Please forward-looking period to

you, an specifically us. On Thank and CDX-XXXX our provide for Good today's clinical update business a you call, ongoing will of of and thank review Celldex-led our studies programs, and Sarah. I the CDX-XXXX. of joining afternoon

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we As potential well we we the and look success all believe forward year. a to future, are forward productive to positioned look for

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data While are plan are still for present been this eligible confirmed, from and year. development to study we as a future complete data including will on review documented, a before We decisions the updated conduct treatment a meeting at undergoing patients this set durable, response later evaluation. full has comprehensive making medical

programs, candidates the system clinical These to a other this these and programs, treat thought stage use strategic diseases. pre-clinical unique to advancing number Beyond call. a of it have helpful are them being be been molecules. see immune or we that few of would a combinations cancer of our specific from of In data you'll types we on highlight XXXX, for engage portfolio human and bispecific actively in developed antibodies

I call to So will the Tibor? turn Tibor. over

referenced, growing programs three Thank programs you to inhibitor, month. the our our CDX-XXXX, expand bispecific both KIT first TAM will and you, our pre-clinical on Anthony. AACR CDX-XXX, going the and presented receptors. I'm be bispecific kinase the next the antibody, programs at Data tyrosine on TAM targeting

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initiating specific to forward providing this path. As clinical on more get clinical we anticipated look to detail the we development later closer year,

with Our first CDXX-mediated program PD-X combines bispecific CDX-XXX activation blockade. cell antibody T called

than and CDX-XXX developed bispecific have and highly we've the the human active antibodies in models. demonstrated We pre-clinical is CDXX individual anti-PD-LX potent that of antibodies, multiple proprietary more the from combination our

perspective integration antibodies combining manufacturing the bispecific and activities Varlilumab and these supports Our a for blockades recurrently of experience initiating PD-X from with CDX-XXX. safety, dosing, two the activity in

macrophages, also making immune been kinases, have Axl, on have These cells, regulate gaining progress for can checkpoint MerTK. on immunity. We the other cells receptors significant importance role receptor as the negatively tyrosine candidates lead been anti-tumor field and as dendritic where immunotherapy known their in and for molecules to TAMs developing they due TyroX, collectively

where of is combination had MerTK an in elicits Our targeting we most in that dosed have advanced and activity or an response with mice when anti-PD-X inhibitor. inflammatory cytokine demonstrated alone antibody program targeting MerTK anti-tumor

human now I'd Sam like on candidates. and of to forward continuing to review and these the the financials. Our to promote macrophages over progress antibodies look human potent hand dendritic to we cells, activation lead call the

Thank Tibor. you,

fifteen for became one stock a reflect amounts, XXXX. Xth, per-share split, February been have which reverse share following the of All effective

XXXX, XXXX. for $X.XX $X.XX For fourth million, XXXX ended loss fourth compared or to $X.X share, loss net quarter per the net XXXX. to million, Net share, the per of XX, $XX quarter of compared the of million, comparable share, was per a or for or per $XX.XX for December period loss $XXX.X or the year $XX.XX was million, $X.X share, in

were in were period ended XX, administrative million goodwill recorded $XX.X XXXX, to in in During year $XX compared XXXX, impairment for for expenses year the December to December ended the non-cash the and for comparable the million XXXX. $XX.X XXXX, General $XX.X Research period comparable we $XX million expense. expenses million compared XX, and million for XXXX. development

and XXXX, XX, million. December equivalents, of marketable As we reported securities cash, cash of $XX

XXXX. now December XXXX working cash, meet are to with sufficient to anticipated of requirements We our expect At through had I XX close. sales December proceeds our stock future over and outstanding. under to will estimated XX, marketable we the combined XXXX, that million and equivalents, Cantor planned securities call at from the capital XX, shares operations cash agreement common Anthony fund turn

Thank you, Sam.

As said focused we calls, past on execution. have we on remain

the combination both CDX-XXXX, arms we types and and expansions dose. at For X optimal mapping for single continue specified tumor out and Phase plans the specific the in will dose, actively enroll study, to agent future determine are

should nearing can XXXX play of are understanding we cancer. important have role where believe a to of the point continue treatment the We a we good of in potentially

then we'll For we and need comprehensive complete, a to the CDX-XXXX, first next review to program. of determine let stage for conduct the steps the study

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And Thank you. Pantginis Wainwright. comes from [Operator your with question Joe H.C. Instructions] first

Your line is open.

Hey, you for one don't the questions antibody. and mention increased thanks mind, additional individual Tibor. With for guys, regard details seeing good if potency the you few afternoon to XXX, A first you're the today. that versus maybe did

of just So just differentiation, and first potency based do you any of nature? you bispecific increased do curious see the attribute this potential safety localization increased then some I'm because also, on potential

you Hi, Thank for the Joe. question.

that any data safety So, in added there's have regarding any concerns. issue, so us our far safety nothing the we of concerns that leads to

safety varlilumab, that combining to the are additional As agonist, our of demonstrated when we those there compared have and data really individual with CDXX from amount nivolumab, no we've you concerns two components. is combined know, significant clinical

also the and you've activation, In is through that of least CDXX as upregulated. CDXX expression PD-LX when we binding. microenvironment tumor predominately at part where receptors additional but activity, the more address… Fc this crosslinked the of be that co-stimulation in the to PD-LX is leads agree occur due I of terms activity may better believe not can only that bispecific the potent Does by to antibody bispecific This mentioned,

at of out Yeah, so the And data. you'll any then more things it. in does. Got curiosity, the absolutely Thanks, just be types CDX-XXXX order, looking Tibor. with not a little it of just detail maybe particular of

being You're be at? you've move you X Stage cautious, in to might deliberate be hit hurdle Stage able additional responses, beyond so to obviously, very though additional even the things looking to and X, just what

what's addition are. understanding that some looking the clearly of the of cancer certainly fully at our all steps understanding data the field in that head happening go the will neck biomarker So, the is analysis, for what comprehensive decision about in data, and clinical so response changes we're in approach and to into paradigms, having best next the

Got it. with program, indications ask a to have expansion regard it. too the SITC late the standpoint or favorite right see I data maybe Off in early cohorts, ask. if then have with if from are the Got dose? know it's you but you don't And XXXX you of to regard what waiting the yet, I'll to a biomarker right continue say to level dose to as cohort increase the XXXX, you reached of activity to dosing

the biomarker microenvironment. how we're biomarkers, is So, on serum the data that we the have from escalation we're through quite dose the is what taking come tumor really informative will we're that collecting, are biopsies available primarily But to understand most which the which based informative. modifying

will just biopsies are help not on-study phase We patients some those this that because with are entering backfill mandatory.

this of combination goal that with will program. to the the and the tumor biopsy microenvironment, biomarkers know So which the data best serum we tumor truly help the modifying are is inform

you And done in safety guess us for people can to mind, patience, this remind other then your anti-CDXX I don't the past, maybe appears versus other maybe be it. Got call why the you've approaches? differentiated you here thanks profile but just with XXXX, the on lastly again and if

for us, to an So could wanted systemic that exposure. we higher achieve antibody select

high this at we for been mentioned, agonist low some compared optimized far, particularly moderate, with same than activity, that are particular agonists We dose expect as CDXX are of even the so linear to observed you very seeing of might perhaps changes at the that with other more of any agonists. it's doses, doses. have antibody low the this They response that have very some Anthony the so

Tibor. Got for Thanks the details, it. added

Sure.

showing over no turn I call am like this to And time. and questions Anthony further I'd back Marucci, President you. to remarks. at CEO, the closing Thank for

at your Thank a we your up you, time Have day. everyone any questions date and to us support, to and as thanks we welcome keeping XXXX. joining appreciate you always, time. look operator, We forward and throughout to today. great And

for the program does you thank wonderful today's Everyone, in and a all you have conference. gentlemen, This may participating conclude day. Ladies disconnect. and