Celldex Therapeutics (CLDX) 8 Aug 182018 Q2 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Celldex Therapeutics Mid-Year 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 be given at that time. [Operator Instructions] As a reminder, today's program is being recorded. And I would like to introduce your host for today's program, Sarah Cavanaugh. ahead. go Please

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

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

These will are on review of factors, today's with Anthony estimates the this changes. not be of new will the be will or question-and-answer factors update events Celldex other Anthony. remainder On could may call. close other a Anthony promise and to carefully the to in assumptions You that statements held over as forward-looking the aware on of Please factors to and of strategy, based differences. that these And underlying milestones our review statements should key like update reflect future there plans the be Tibor any information, of does outlining and I'd or changes all will these now to information, year. call cause the will the program, be call. financials, call, you advised review Sam period turn the close, for business begin at clinical forward-looking

Sarah. you for you, joining and Thank afternoon thank us. Good

you has interest long As know, Celldex deep held experience immunotherapy. and in

they and therapy this cycle, to belief number unique most to biologics. When used cancer the We knowledge of immunotherapies of benefit. approach Core are there is very that set targeted have when a to immune clinical intervene. targeted promising the considering key areas immunity system the our scientific support develop approach combination the a to is

responses, against effective cells, CDX-XXXX cell are process targeted to tumors. responses and cells, tumor prime antigens certain in from also new immune resulting liberated immunogenic most an modes that help the response generated presentation help inhibitors active immune T are need from While dendritic role on other can initiate keep that the like to death turned which This therapies cells be key against checkpoint this radiation. pathway responses. we specifically indications, extend and of by relatively where the antigen focused, or One to agents enhancing cell CDX-XXXX, we checkpoint beyond in like products of rare can tumors, is immune are therapies are the to responses off, immune varlilumab, allow especially being of

varlilumab a is which not checkpoint - is the the in need numbers, which pathways, costimulation other in in them, we critical That reasonable agent important immuno immune suppressive optimize there that We cells we can are process. the the benefit as a activating And the cells needs are CTLA-X developing an you through programs CDX-XXX earlier pathway. said, cell mechanisms where of only addressed dendritic cascade, part stage T prime also Likewise, by that to that immune pathway. promoting efficiency to plays fit can CDX-XXXX number system, the dendritic and the and to this by the need of boosting pathway. be targeting need beyond several clinical where activate CDXX role PD-X do increasing cells of CDXX to dendritic target and is

will including on through In financial programs the this, the later points. required to we direct Sam have call, inflection cuts savings projected support initiatives we XX%. our outline we cost XX%, significant decreased of are key that April approximately to the that on restructuring headcount burn made a as these to reduced in by operations, Importantly, resources see XXXX and for our confident hand our has corporate by business

focused and cost, savings the glemba will efforts significant the solely included in realized from be to we patients on most shareholders. can cost resources financial directing and to advancement bring XXXX extending These value As our are this believe more significant. of both programs effort XXXX the

pipeline believe well to Tibor? to the half an second ask succeed With We will of progress. are to productive we year. provide positioned continue overview, Tibor that a to forward update on and I look the

Anthony. Thanks,

CDX-XXXX, types. an macrophages, which dendritic early results studies. CDXX, cells, clinical cancer on immune found, fully CDXX let antibodies a update several antibody also So have cells, with is Both to encouraging B responses a mentioned, shown the human as in me agonist and of key first and activator start targeted on on

relative to molecule activity, more And CDXX of receptor CDXX synergy with CDXX Fc CDXX potentiate CDX-XXXX allowing with Also agonist activity. has may ligand that interaction, cell activation not interfere does However, systemic activation. strong not broad has cross-linking unique properties its and the a have controlled through consistent the results that It We activation associated observed ligand. limited CDX-XXXX require we the by that binds toxicity part natural immune does with other CDXX antibodies. agonist of their dosing. in agonist to believe unique

demonstrating remarkably a while in profile, has potent pre-clinical CDX-XXXX our immune activation safety good studies. Finally,

Our to ongoing a is important X Phase few study answer questions. designed

escalation. First, identify dose is goal dose our optimum primary through to the

that the those in is dose without milligrams per provide not get good solid toxicity, with to advanced achieve locally necessarily weeks intolerance. point other tumors CDX-XXXX milligrams patients ranging has metastatic the that to systemic a to progression dose or levels recurrent kilogram highest eluded a X.XX CDXX antibodies to will but to study phase, It's the potent until at four agonist important every X X dose, disease exposure clinic that out this date. During once goal per rather or tested mg/kg limiting goal kilogram, from this receive in level

the prior of this the agonist, guided escalation in we given some past, dose study As take potency the have will time. CDXX of portion

and can specific the a period dose We are between level. wait before increase X-week after to next patient in last dosed observation must patients a clear dosing to is also required we each the within cohort cohort

toxicities, data cohort associated biological limiting and have activity We on date great of at progress suggest dosing these profile enrolling activation. that with milligrams CDX-XXXX is the has clear cohorts cohorts and safety made kilogram. currently desirable X.XX CDXX three demonstrating Data a so per X.XX signs fourth completed, it to dose any kilogram. X.XX, with milligrams the to X.X We're biomarker from based far, per the without

phase number at of growth a the cells agent CDX-XXXX. want potential increasing dose As the the as of number increase cohort use cell escalation to plus could CDX-XXXX. CDX-XXXX cells to a dendritic using priming of to factor dendritic fixed we impact a increasing combination the available this of we the of call, doses Anthony mentioned end, CDX-XXXX. To with is dendritic CDX-XXX a the start enhance dose study of CDX-XXX perspective, CDX-XXX to to respond added from of have that scientific the

Once have types. will new move agent cohort the specific optimal begin cohort extension next combination We enrolling dose in into we we both in expect and tumor the month. to this arms single identified,

Annual to initiate we very presented interest along forward and this a out metastatic at overall to at receive dendritic Preliminary with sponsored systemic as cell and is for cancer. lung by single that injections for help once-a-day to proof-of-concept have better non-irradiated continue response the combination grow tumor evaluated patients therapy some survival a continued Our several progression-free are to these we cohort In by this Medical expected by data April. the of Nitin Montefiore investigator seen the subcutaneous five patients. CDX-XXX. demonstrating of directed additional led We lesion, non-irradiated tumor. then move The Chandan Center radio immune radiation coming rationale plenary response refractory patients The the doctors, study, in study antigens this in a of the combination look Meeting and non-small stereotactic has session data will and irradiated body to lung data forward. CDX-XXX in provided mobilized study as advanced than were released tumor the and Guha cells in AACR tumors partial Early with in with has CDX-XXX updates from CDX-XXX important monitor with responses evaluating Ohri. study tumors with we'll an with receiving intriguing study associated in patients by survival the

been role update implicated resistance, which antitumor study, treated oncogenic CDX-XXXX also the tumor as cancer, Simon second Using combination growth, response on achieves given with currently on the variety Phase two-stage were affinity as as checkpoint on patient a of and therapies. to X will Xb state, progress well and enrollment progressed among with XX study monotherapy. it's negative, partial and and with least specifically enrolling this a in CDX-XXXX, previously Phase with EGFR study CDX-XXXX patients evidence its with and who activity an advanced will previously open of and called and these portion and squamous Erbitux durable ligand potent cell targeted cells carcinoma, the deactivated to uniquely combination in to interaction and tumors with locks of treated it is HERX. CDX-XXXX one monoclonal play design, cancer stage. is Erbitux antibody who ErbBX, overcoming Erbitux targeting important is complete drivers. have an a In and response, cell resistant inhibitor, nine found ErbBX Next, anti-PDX with can in and become cancers, patients, is at I a HPV patients inhibitor a may head involve into ErbBX label in a targets survival including if saw also head of it previously neck first had An patient we neck Erbitux. completed with the other have resistance a with a

entire set data to enrollment full use already inform partial plan first have the decisions. stage confirmed and to the complete but response, next experienced We to we will a

such types and Beyond to play as thyroid, believed role as ErbBX head breast, cancers is and tumor lung in neck well several melanoma. solid as cancer, a other gastro

We inform study indications and decisions portion of explore and the potential the will first steps. opportunities from our continue on largely next to other additional and neck data head

during agonist varlilumab, our with to our in being started to the in several Moving Phase an Opdivo, Bristol-Myers study June, collaboration X/X from of which results conducted we Squibb. varlilumab, presentation oral Meeting ASCO at cohorts with Annual is in report combination in CDXX antibody

with As cell the X glioblastoma. portion cell ovarian five indications: head renal squamous carcinoma; study enroll carcinoma; design to patients cancer; a reminder, cancer; colorectal and Phase neck across and of the

of detail treatment, tumor some increases observations significant ovarian of For expression very and before covered historical outcomes during patients. of months clinical great want lymphocyte, the with the demonstrate PD-LX response infiltrating greater favorably June, ASCO seven tumor CDX+ outcomes, to in highlight with progression-free Analysis samples These increases than data and in half were improved checkpoint from alone. do paired from I compares more cohort. and inhibitors in XX% a associated cancer our of the survival to rate, which of was than and tumor including

and the outcomes. had biological cohorts, whom response cancer, and was primarily patients. IV tumors preliminary response head additional reviewed the treated renal from XX% We XX% HPV distinguish tumors. to that two had We've neck may have cell combinations in Stage PD-LX analyze squamous confirmed of negative being carcinoma or continue the The to recently study. that therapy the low the or further with with we may four had patients cell patient improve prior XX% very information to signatures PD-LX all of had and patients were carcinoma how XX select clinical positive and defined therapy, data for can overall occurring XX% responses in lines Patients a rate negative and neck median head disease of that

These were treatments, patients RCC anti-angiogenic patients Given range treatment, had were the with experienced of and half cell the changing of were disease. cell stable and to the the one all cohort. XX% in renal with environment all four of negative, Stage carcinoma prior patients treated disease a only therapy, patients prior renal PD-LX in XX IV

to-date data are effects not for checkpoint some on seen clear the led typically meaningful biological patients. to varli-nivo While, that has the from combination, forward there in path we a have the impressive of And have these response patients combination were in some therapy probability tumor some alone. to have low cohorts responses can

earlier, moving as therapy. said understanding differences those who it us patients I select patients between important As for respond don't for allow varli and what could are best forward who for varli, the suited will those be

last the in study, forward glioblastoma to cohort medical at out Finally, close look later from data presenting year. the a meeting we this to

we pleased be CDX-XXXX. option and test would lymphoma study a with the based see observed to our combination CDXX provided year advance combined on ongoing through to antibody, An we synergy studies, enhanced of at targets the investigator-initiated PD-LX in Also CDXX Earlier several partner and through studies. antibodies. in activity, first PD-LX portfolio, Phase externally X varli explore which from in both CDX-XXXX and bispecific when to when preclinical of in and to ACR, preclinical combination we models varlilumab. bispecific potential and data our internally vitro further inclusion to as combination varli's program, compared continue And the in We CDXX comparing PD-LX. the this the continue our anti-KIT are vivo monoclonal our

with mast an studies generation clinical first in be manufacturing Our benefit will prolonged translate that CDX-XXXX will in the cell-related this clinical a demonstrated completed diseases. to IND tryptase potentially suggesting antibodies make these marked cells levels, disease. that financials. of inflammation applications suppression infectious we will decrease enter to believe good by We checkpoint continue over enabling year, now Sam on the in important mast anticipate like I'd call experience XXXX. and against TyroX, the to MerTK, have review We'd broad TAM to candidate AXL in our and oncology, selecting targets program also progress lead which the hand and clinical the

Thank Tibor. you,

of net compared of loss or $XX.X the $X.XX per in per $X.XX XXXX, $XX.X compared was For XXXX. or $X.XX June to to per share, of $XXX.X million for for Net a second million the second comparable quarter loss million quarter per was XXXX, the loss the million period share ended XXXX. or $X.XX $XX.X six months XX, or share, share for net

quarter for intangible expenses. During or compared General and for the per compared first million of million the for million comparable period administrative goodwill million months $XX.X XXXX, XXXX, six to $XX.X ended $X.XX expenses and June one-time expenses share non-cash impairment months the period six million XX, Research development in June XXXX. we were recorded XXXX. $XX.X $XX.X for XX, XXXX, to the ended in comparable asset $XXX.X and in were the

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

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

the of also the program review in build back approach Thank to good are provides regimen the taking we to a tractable themselves, you, only today's overview cancers. Sam. believe come not I but right

are months, we to six forward of opening Phase important to will we future, of over continue I'm cancer. the very remainder of nine understanding believe XXX We up on As And combination enroll the year. CDX-XXXX, the can the a play to that very X execution, should for the to focused the look CDX-XXXX looking we have the good role study in believe the cohort we next soon. in we treatment

neck coming the in complete For X for first next the steps the study the Phase to will months, in and use portion head data - CDX-XXXX, we enrollment and the determine we'll of the program. of to cancer

later this lymphomas, killing both results and be potentially dual Opdivo the where X ability the have may in of CDXX direct the study to CDXX the we and immune and a evaluate advantage of take combination we'll varli, And year. to cohort combination of of For to will have presented mechanism activation. B-cell action XXXX the glioblastoma Phase of

open in Finally, antibody, studies for anti-KIT will would XXXX. review, of I enabling by floor up initiate year CDX-XXXX, our the we X complete that will studies the to IND Phase questions. Operator? end and anticipate With

from [Operator of Certainly. comes line Wainwright. from question H.C. Instructions] the Pantginis first Joe Our

Your question, please.

cool. Hope guys, Thanks question. you're staying taking Hey, the all afternoon. good for

with XXXX, this more how with bit what's to especially Maybe so regard points then toxicity and maybe regard far to to can is for follow-up. you others, antibody. about have to with what the little details made So compare some to a And a appears your might regard contrast the unique do of appreciate be relative Tibor. about to quick regard it With really I you others? compare reduced systemic to

Joe. been enhance to activity of CDXX taken Sure, antibodies. have you. agonist several There approaches different Thank the

of we Fc the provide include antibody cross-linking of selected, Some of other with other lead receptor the the Fc CDX-XXXX course to the for without to bind which cross-linking requires the approaches modifications activate enhance to receptors or domain agonist and interactions The any appropriate signaling. is region the activity. molecules. presence antibody to interaction requiring helps the Fc of and able approach That with receptor, Fc in

clear one distinction. that's So

macrophages we us within think antibody current so allow that systemic far. was of to being that bind cells ensure good exposure. give doses Another would that clinic dependent microenvironment. cells, a would the a engage CDXX of We with that that would levels activate antibodies and factor that that we used way to it the will in selection in achieve in are believe tumor dose in doses to such with the important the manner CDX-XXXX able And greater than really require dendritic used some is it's the agonist dose

looking as guess, be to to regard helpful. you. with And, might I very is, escalation, there relative actually dosing relevant? I important because to for here you're at Thank thinking analogous are about quick varli was scheduling identification That's or not Is and activation, that considerations follow-up dose my decisions any varli. know even it is for your immune that something you're the that

No, think important. it's it's certainly that and relevant do we

agonist too frequently experience rationale that be not believe We with is for we may CDXX suggests have dosing some and antibodies certainly prior there that. optimal

move So that four pay week course, an our the as terms the going are the really as in the that every things the appropriate is to determining frequency why strategy we level of selected drive regimen X data dosing dose to to will certainly escalation. dose forward regimens, but we're Phase with. attention both best well of dosing But, in

Thanks Great. a Tibor. lot,

welcome. You're

you. line [Operator Thank from the Peaker of comes Our from Instructions] Cowen. Boris next question

Your question, please.

Great. Good evening.

I'm is is So dose do adjust you CDXX. you you each can how and how my best which first question agent curious, combine even just working or actually XXX, on tell When XXXX individual drug?

this very question. Boris, effects So, good have biologically. both Tibor. unique It's a is They

our for And the is be cells, the from see including of number a that of increased the dendritic effect track we be biomarker that from to we of effect point view. body drugs very so, perspective, of data significant most describes which pertinent able, a able biological will certainly we the effects have which CDX-XXX the

our arm. XXXX, combination additional dendritic will enhances subcu of CDX-XXX So to, that I X resulting in the dose course, recommended for expression cells. cytokine studies effectively these for that will and drugs able daily And, landed We've that's that effects. on in an suggest a be quite biomarkers regimen the have their activate suggesting number show will cells these blood stimulation. are the example, Cytokine of we have the to both bit in forward as active already which determine having a for moving CDX-XXXX of combination will regimen monotherapy we and think data that relative

efficacy specific neck, continue and question for actually development Got timeline And just in do And you. what and could of kind drug to a when varli, carcinoma. I'm you assess my head renal it? curious threshold have where second is for this you cell

to, Opdivo? reference in with combination In

in at forward point have several dataset Yeah. Or decision a just to studies, general, get - this you or program? need would the ongoing you do make what ongoing could to see move you to that which which in to not since studies, point on you and

well seen varli, as will it. So for I with think, we clinical opportunities combinations to provide continue some we've very the biologic as effects best what explore important

We of to seen. a bar specific be needs set what haven't

selection, But between where significant As we see mentioned, we don't don't that that understand those currently are better the the or tumors activity forward to nivo to I a that either continuing hot. We have cold turn which from to patients, whether into path on in and understand difference reported the could and patients the combination. additional responses, able for clinical that be data neck, the To from head understanding clear by and patient are brought by patients, renal. their perhaps difference we respond. have through in combinations those enhance

Yeah.

in and on Opdivo the Boris, remember pembro are many with of the isn't setting. patients of or in of negative, PD-LX single-agent a lot there the activity heck information a also study

rates to So an comparison do, hurdle need be able the apples when look what at to to to going we here. be, apples do we

Got you. you my questions. taking for Thank much very

Thanks, Boris.

you. Thank

comes of question from Stephen line next the WBB Our from Securities. Brozak

please. question, Your

size cap a the do. immuno-oncology trading have that know you're you I'd of go aren't to at actually like picture afternoon, in good experience I at - with question. realities how for right should that the obviously taking franchises as any cash. of discounted at now? Celldex, much of And Thanks look as that macro gentlemen. that Because are terms Celldex, there a market we many Hey, more

I've give think running, of in So should look you're how that, the follow-up got us then, franchise? in position XXXX? in evaluating terms Celldex Can in we you at trials you And what please. that after positioning yourselves what about the -

so - important think, our around going think, immuno-oncology space us. I it's other strategy taking out Steve, what's of perspective, a this talked an I XXXX therapy combination to We today. the and with along CDXX mean, a that. fruits whole ahead, is bit from see been a differentiated suffered always I We now. that. oncology diseases. asset little we've there But we've Obviously, take about lot that's Yeah, it's again to a few think to But think more about for highly that of compared months the as

just So in for But targeting expect early doing the the we've patients I suffered company handle today we've and that's late basically the SITC enhance combination you. escalation. always focus at to looked a immune of some at IOs year, a the right in data hit system, bit been accordingly. will November of itself. way, said what on long-time little the really that, dose activating that - the ourselves, while immune But to the a definitely that APCs putting taken the think system of about with together what the this we're we've drugs order I continue. That's have

that obviously mentioned because leads the follow-up, you that. me And just to

than should And company the more at Thank collaborate the else fact universe ability while. that after How immuno-oncology at options in that given do far that anyone have with. could I'll with that. you space are? potentially you. yourselves line, How - multiple that what are doing multiple quite given can there, companies we've we are the the hop you pretty for collaborate you position multiple that out combination you could along to in drugs looking that companies any - understanding queue do we're back the Given therapy you that there a there look size and so work a that with could that you fact been

for data mean, let's that's that what the I real Phase I have the to Yeah, parties we and look and think you. very to through get Obviously, partnerships tells us. appropriate the that down Xs or point, road. at see decide engage the us And can forward something collaborations, for what

again, Great. Thanks gentlemen.

Yeah.

the to Thank remarks. you. today's further Anthony to CEO session And program. I'd any conclude the does hand back for this question-and-answer like Marucci, of program

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

does and Thank your you, today's the gentlemen, participation This for program. conclude in ladies conference.

now You may day. disconnect. Good