CLDX - Earnings call transcript Q2 2019 | Celldex Therapeutics, Inc.

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Operator

Hello and welcome to Celldex Therapeutics Mid-Year 2019 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 conference is being recorded.

to host like Sarah today's now Cavanaugh. would introduce for your call, I

may You begin.

Sarah Cavanaugh

afternoon. Senior on Celldex With are Good President you. Thank me Officer; Scientific Co-Founder, Keler, Vice Officer. new Senior team, Executive to Vice Dr. Martin, and and Dr. Regulatory Tibor President Chief Chief Medical Anthony and Diane Affairs; of the President, Heath-Chiozzi, CEO President Financial Senior Dr. of Therapeutics; Co-Founder, Vice Marucci, today call and our Chief Margo Sam Young, President Vice Officer; and

speakers and to like are Before and be we uncertainties that materially I statements with discussion, statements. differ begin views actual those expressed reflect from risks events future based by forward-looking could our cause on or to respect would mention on implied to current assumptions that today's and results statements. such making Such to will forward-looking subject

Celldex's of and those Results Operation those to Celldex's under Discussion of on might results Factors the and and of differ the and include current statements actual forward-looking Management's and Analysis annual in from X-K, cause XX-K, described Form Financial materially its set heading those well its as as reports releases. other on Form filings on quarterly in the Form Risk Condition reports that Celldex's factors the Certain with press forth in XX-Q, SEC report

cautionary All in forward-looking this entirety notice. statements are qualified expressly by their

of these factors all and review other differences. that there carefully should these be aware cause You factors be that could may

reflect other does any events, estimates and on new assumptions are of statements and not forward-looking changes this changes. to or or underlying Celldex based future factors, forward-looking promise These in information, update as statements to plans, call, information,

the held that period advised the of the at call. be be close will Please question-and-answer

over call Anthony. I the to like to would now

Anthony Marucci

our update in providing first Good and a Sarah. thorough forward thank made of to look and this We you the afternoon. the programs half you, excellent us. on for afternoon you joining progress year Thank

our well at remains you look strong overall, the and business As pipeline diversified.

poised clinic, a fourth the lined We year-end, have nicely third two enter programs before clinical in a XXXX. to up for advancing and

this of We believe pipeline. support progress product strengthen summer that important and our also the made development clinical further our continued efforts an will hire we

Diane novel the a Medical functional registrations. cross and and medical successful product Officer. Celldex joined teams Young global and Dr. Vice clinical therapies oncologist development has I Phase President as is has Senior the through from team of responsible Diane numerous led Chief development for and a research

GTX, a focused Most recently, nuclear Diane of Inc., drugs Officer company on public the biopharmaceutical that served target development as Medical Chief receptors. hormone

spent XX Diane affairs. years in senior Previously, medical and Oncology and global roles at clinical development leadership Novartis

drugs. development, successful dozen the to As oncology regulatory the oncology half directed head she of approvals clinical important a than a leading more for clinical programs

the Diane positions as Novartis, Sandoz. held well Prior at to development in Johnson senior Hoffman-LaRoche and Pharmaceutical clinical of R.W. Research Institute leadership as J&J

are will We Diane on and venues. her team. our enjoy fall have and at conferences meeting at us sure I'm this join medical our both She will very shareholders investor these pleased to

we extend the shareholders. bring to resources our sheet and of to to balance continue We direct the and believe value our most advancement progress patients both strengthen financial to the can

employees be facilities. manufacturing in and of company's facilities. for our renewed laboratory the June, not into Fall be facility decided The to Massachusetts Massachusetts we will most will this, Needham River and In support consolidate manufacturing the and integrated direct lease functions

half in year, million executed earlier annually reduction We New this of Jersey along estimate will a our over that square XXXX. facility over with this the footprint of by second the us our decrease will $X.X facility footage starting save XX% consolidation, Hampton, and in

Then of I'm this open Martin, CDX-XXXX, before to to the like turn for medical the Regulatory Margo our lead CDX-XXXX with pipeline. ask to your review preclinical CDX-XXXX. served on an the the Margo as to I'm our Sam of going I'd to going update call an financials provide start programs. our Dr. of to date. we that, update With Senior review and Heath-Chiozzi, a CFO, VP questions. program has to Affairs, will then our

a is antibody cancer and key to macrophages, targeted CDXX, immune the CDX-XXXX a human response cells, B found on cells activator which is fully several of dendritic types.

agonist results antibodies encouraging have studies. shown Potent in clinical early CDXX

activation toxicity limited systemic CDXX their broad with has associated dosing. However,

It which to other results CDX-XXXX agonist may that selected to a unique at its and non-dose-dependent receptor agonist systemic on a higher better for We antibodies. activity penetration allow binds CDXX tumor dosing the CDXX based relative optimal manner levels. in properties agonist in linear, the

consistent does CDX-XXXX CDXX through local agonist Also, its and the require controlled not by activation. ligand, natural activity, of receptor cross-linking immune not responses. more allowing cell immune does for which activation interfere Fc CDX-XXXX may with potentiate interactions further its

Finally, CDX-XXXX studies. immune had a strong our safety demonstrating profile, activation preclinical while potent in

advanced, multidose, locally with or solid escalation CDX-XXXX and of a cell dose ongoing in The is tumors I study Phase recurrent lymphomas. B metastatic trial patients

study the The dendritic these includes is combination dose which are cells for important cell number CDX-XXX. potent key CDX-XXXX of of CDX-XXX with factor target arm growth a in separate a also CDX-XXXX. a escalation that increases

cohorts that made will of escalation study the arm. systemic end, this all without excellent To good dosing have progress dose-limiting we goal eight important dose completing monotherapy of is An in provide to this toxicity. levels achieve exposure CDX-XXXX

based biological on data, Importantly, CDX-XXXX CDXX activity is associated activation. biomarker strong with demonstrating

combination patients in of provide at selection levels the additional Currently, highest dose II completion in data arm we of dose adding three dose the of the additional recommended to Phase as await our escalation we the study. are the

we of combination assuming fourth per the the per mg potential six nearing X.XX the XXX of the successful With kg. shortly. CDX-XXXX cohorts for close X.X the open And window at cohort mg are DLT should and clearance. combination, kg

at other targeting tumor can significantly pleased Overall, administered safely agonists tissue the and doses at CDX-XXXX are than data that will that penetration have which most date believes shown good we CDXX. Celldex with support doses higher to be and potent

enhancing an CDX-XXXX the will the the break checkpoint to system is be the important immune of releasing CDX-XXXX. step on include the that and This system study arm inhibitor the inhibitor. of is as next combination with immune introduction with both cohort PD-X the additional with to we'll Our add

We potent and antibody exploring CDXX agonist opportunities future also therapy are radiation Celldex's monoclonal chemotherapy, combination varlilumab. with

We and about meeting at are at SITC the an XXXX excited study update from program clinical to its presented and data April We present November. the in in this early potential. AACR hope

CDX-XXXX. Phase a we study will subjects. antagonist initiate program KIT is of of year-end, in CDX-XXXX Before also antibody variant our CDX-XXXX, reengineered a healthy I

and of and provide numbers, decreased and cell with in a mast antagonist an concept supporting that of activity mast diseases. mast preclinical KIT potentially targeting inhibition antibody is cells clinical cell the mast CDX-XXXX demonstrated benefit and cell cell key mast regulator a modulate data related clinical robust KIT can activity with

safety CDX-XXXX a full activity. was oblate interactions redesigned KIT while to Fc proven inhibitory profile, effector functions preserving receptor and and

to modified extended was administration. CDX-XXXX addition, In provide following half-life

Phase subjects. is the ascending This single safety in doses pharmacodynamics CDX-XXXX evaluate study designed Ia and healthy to of profile, pharmacokinetics of

the decades. six play trigger. hives, completion in out idiopathic CDX-XXXX CIU of over or study, least even angioedema presents a Multiple as study without for to we further at specific episodes itchy both plan weeks can Following chronic or years CIU. urticaria,

of receptor up the prevalence total or control CIU of inhibitor and relief antihistamine/leukotriene patients patients. An be leukotrienes CIU The more and with of in the of roughly for effective cases provides to Consequently, estimated is is symptomatic such the half refractory agonists as need IgE later X.X line Xolair. there therapies. remaining for with X% million to About population to United achieved X.X% XX% States. antihistamines

We KIT hope believe this fall in CIU We will a rationale continue strategy targeting keep mast with updated and present unique as to scientific meeting the and to involving in at you medical of supportive development data such CDX-XXXX diseases CIU. a our on program. represents cells this strategy

I had on AACR discuss to the over Before the touch second a at quarter. showing to pipeline want Margo our in I hand strong which preclinical call CDX-XXXX, to

first bispecific program, our CDXX activation PD-X CDX-XXX, combined with blockade. mediated cell antibody

demonstrated preclinical potent CDX-XXX models. human antibodies and of be developed bispecific active combination the the anti-PD-LX individual to CDXX have We proprietary, our the in antibodies from and highly than more

its with activity sets own pathway provides our CDX-XXX potentially PD-X with up us inhibitor combinations Celldex within pipeline. own for unique and broader

support XXXX. We CDX-XXX targeted IND are currently to initiating manufacturing for activities an for

making been Axl and the collectively the tyrosine MerTK, known TAMs. TyroX, as targeting lead candidates kinases, on also receptor progress have We developing significant

checkpoint These gaining importance been on where cells receptors macrophages, as the immune cells other have immunity. the molecules dendritic in and negatively role antitumor immunotherapy regulate due to can their field they

characterizations We all recently progress on at presented AACR. lead our receptors three antibody for

and all MerTK, towards The activation antibodies forward macrophages cells look Axl promote these candidates and to and human moving development we dendritic activities. TyroX, of targeting

With made with that ask we've discuss to the will I Margo? CDX-XXXX. Margo overview, progress

Margo Heath-Chiozzi

in breast, in which cell and a of a cancers as well Thank resistance monoclonal thyroid, gastric you, therapy. and to as antibody is ErbBX also is It HERX. cells cancer is ErbBX, found including as called neck, cancers, on implicated as survival is Anthony. melanoma. targeted targets tumor CDX-XXXX that variety well growth lung, head

signaling. Uniquely family other are an ligand members into for that locks interactions among with ErbBX its ErbBX-targeted inactive blocking interactions state, CDX-XXXX immune antibody, its necessary with ErbBX

is have further half-life, In to its enhancing addition, engineered CDX-XXXX extended product an profile.

generic cell carcinoma cetuximab-resistant, prognosis. a options have study We limited in in a poor treatment neck checkpoint patients are advanced with name PD-X patients particularly squamous II conducting been combination cetuximab, These with who inhibitor. previously Phase head of with Erbitux, a HPV-negative CDX-XXXX and treated extremely have and

studied been with two In in served Phase clinical treating ongoing with patients in activity included clinical and trials study, these number across cancer has in other cancer. and of CDX-XXXX patients head head addition to neck neck studies. three that We've been the II a

exploratory that clinical mutations associated in from genes. may CDX-XXXX somatic Emerging biomarker the antitumor across suggests development be with activity data specific analyses programs this

study, of and in the Julie results in presented ASCO biomarker clinical Bauman program of analyses Chicago. the at the Phase II Dr. an investigator Center, the Cancer in interim Arizona annual the CDX-XXXX meeting University

a Phase quick First, the then of analysis. overview interim into biomarker me dive the you and we give let results will study II

or CDX-XXXX occur study, six Treatment the the progression weekly In administered continues and weeks. is once every into weeks. disease assessments cetuximab and is dosed every intolerance three

to achieved study first patients. response, Using was partial a And would design, to or enrollment one a two-stage enroll if Simon a progress This the met. was of XX patient second stage objective least complete stage. at the the designed

All one X had patients checkpoint The treatment refractory. were a studies. the X. the prior therapies XX patients cetuximab range received enrolled prior XX a were cancer with of of to in patients stage three and of had of XX median

complete cetuximab. in not treatment limited, treatment patient where response continues had clinical who durable to population treatment an and at including a very patient receive options over and activity a Notable are observed in received was this refractory response year that continues this unconfirmed partial a

patients a XX% partial unconfirmed rate was the the stable response including and of best their of responder overall benefit experienced XX% observed. disease as clinical

expected the with combination cetuximab CDX-XXXX associated The mediated of of with adverse rash. events and on-target generally was diarrhea

The studies. the and was in patient clinical our and difficult-to-treat notable similar was population neck in patients this head activity observed previous to experience from

could patients, three clinical that the patients with Understanding care change of the with next-generation CDX-XXXX performed strategy cancer XX we sequencing samples standard for neck enrichment across from these on a and tumor treated head studies. biomarker

data the cetuximab with refractory this responses, total, year patient a clinical In CDX-XXXX complete four responses, patients of X.X durable and including patient two over treated a combination set in patient the with cetuximab. a included and with with months

patients who tumor patients response shrinkage included doses The untreated monotherapy. disease an and than also CDX-XXXX progressive eight of response six XX% patient previously tumor two naïve unconfirmed with in and/or in patient a and shrinkage stable with disease. exceptional the partial cetuximab This greater with partial received

We CDX-XXXX NOTCHX were mutations and were FATX found NOTCHX genes with there NOTCHX, including associated and across that activity. specific the clinical in that program,

mutations. Inactivating NOTCH genes and in normally may suppressors, neck tumor and sizable mutations neck as uncontrolled cancer, subset these genes HPV-negative head XX% growth. prevent cell containing contain head and that FATX XX% occur and tumors a with in FATX FATX In genes function of

seven Specifically, mutated ASCO, patients identified four of FATX having clinical and of which response, in three the exploratory as analyses were presented demonstrated tumors a these patients at confirmed. were

XX, total the NOTCHX, And had all clinical patients benefit, of FATX who of X NOTCHX or four who NOTCHX, NOTCHX. note, clinical patients of in responses had X occurred mutations. and/or or X Three the experienced

observed responses patients site clinical also four of oral we all in that a cavity. primary Finally, with tumor occurred

significant was larger We these these there findings in for a interim our and exploring discussed results with investigators clinical setting. enthusiasm

future FATX we up patient with evaluate XX II ongoing. of these a As Phase is for including will least utilities patients result, involve XX and the our current expanded to at to clinical Enrollment study mutations have selection. biomarkers

We investigating FATX CDX-XXXX preclinical the of association are studies mutations also and and sensitivity conducting of NOTCH. inactivating

that the while Dr. Bauman these ASCO enrichment and As presentation, could care are a for patients. the strategy suggest biomarker provocative at these the change said potential of in data, for early, standard

this the fully We to study here. in more obtaining elucidate look to potential forward data ongoing additional

review turn over With Sam? Sam to call the that, I to financials. will the

Sam Martin

Thank you, Margo.

XX of February which All share the amounts reverse a X, share stock split per reflect XXXX. for and X following effective became

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

XXXX, recorded goodwill one-time $XXX.X non-cash and we intangible During in asset, the first million impairment quarter of expenses.

million months XX, for expenses for comparable the Research ended to $XX.X XXXX. were the $XX.X million in six compared development and period June XXXX

million six comparable XXXX. June for $XX.X the months expenses XXXX and to General for million administrative compared in ended the XX, period were $X.X

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

cash that sales proceeds agreement cash, common to and under XX, with at stock planned XXXX. meet the securities working through Cantor We future equivalents our and operations from XXXX, fund capital June marketable expect requirements combined are estimated our of anticipated sufficient

had XXXX, outstanding: million we At shares XX.X June XX,

will to to over I close. call the now Anthony turn

Anthony Marucci

the very Thank I'm the both with Thank and progress on Sam. Margo. pleased programs. our you, CDX-XXXX you, CDX-XXXX

over potential. Importantly, be should to advanced their XX these able we X point clinical key the the to we questions answer have that next months to programs on

well with additional will mechanism for and actions those and CDX-XXXX be of Expansion important cohorts combination key other are underway.

position good the that select combination dose the appropriate putting is cohort is combination additional inhibitor next. for us a combinations, CDX-XXXX/CDX-XXX completion including dose in to of escalation, The PD-X planned nearing

neck be are new to investigator significant a which with a the the and the CDX-XXXX allow enrolling development and study cancer field potential biomarker actively validate significant amended have We to us overall in support. will for for strategy patients head

before of year. advance We initiate CDX-XXXX study the track at also and to year-end on programs remain Phase to bispecific I next clinic a

months depth with and news of significant pleased expanding coming will inflection flow and XXXX. in believe in breadth are points the support We our and meaningful it the pipeline

review, With Operator? we questions. floor that will to open the

Operator

[Operator Instructions].

Our Pantginis from Joe the comes with Wainwright. first of question H.C. line

Your line open. is

Joseph Pantginis

Thanks guys. for Hey, question. taking the Good afternoon.

I you on competitive if don't want where just but to escalation the know be don't my dose apples for focus you I question First, if specifically maybe safety part that, to XXXX others XXXX, levels really to profile. oranges, mind, is do safety signal the expected a might landscape? to as have you of might your related surpassed you see that in feel

Anthony Marucci

question? Sure. Tibor, can you answer that

Tibor Keler

Hi, the know mean surpass I exactly don't Sure. you Joe. by levels. what

This become level We are the clinical not of been a generally of have point dose with in agonist reported activity biological of antibodies. higher by with the kinds that or our some safety somewhat have but from are associated a doses, of these reached that certainly trials has we where increased other any have activation view. seeing CDXX limiting

and looked cytokine levels. terms the So, at expect the that see of that has to responses, nice very clear while dose high very good see we that's chemokine activation in we signals been immune

Joseph Pantginis

Right.

So, levels where shown at at have just safety personal basically levels, their levels. own their others

Tibor Keler

Correct.

Joseph Pantginis

you're to Okay, program, approach. personalized got XXXX medicine the it. And pursuing very a moving then, obviously, nice

maybe frequency you maybe wanted of the of have overall population looking a data? are you get head what Or additional in here, stated FATX NOTCH neck to population, kind at? mutations sizes to So, just mutations, sense general with or the of bit with any differently, and a the looking ahead and regard if these starting

from diagnostic this more then, to point? translated generation can something are lab a but be Thanks. these I next approved said if be you diagnostics you that using standpoint? it with And were commercially are know at sequencing, that,

Margo Heath-Chiozzi

Margo. this Joe, is

good the field going genetic look when study and confirm drugs if to on a and because current early And tests that confirm epidemiology, do and many do genotyping neck good seen tumors FATX I sequencing we're biomarker, a haven't is we're for maybe earlier, mentioned currently more to clinical targeted to collaborate would available and head next with at of the you the change there it diagnostic to appears the then, FATX tumors As generation actual testing. as that to clinical and third be companies the evolving we a that gleaned going clearly test observation. been sort head is the tumor of to where neck patients you help tumors because to. there quarter. is is guide head of be the inclined neck information enlarge from as to But predictive therapies about Current NOTCH the sample that

pursuing two-stage a stage we're of really. process actively it's enlarging understanding And – one. So, our

Joseph Pantginis

Got that's helpful. No, very it.

was regard have on the of the I to some particular study what the mutation. with think combining made comments I you patients

So, thanks for clarifying that.

right. it. guys. All Appreciate Thanks,

Anthony Marucci

Joe. Thanks,

Operator

further Thank like for this you. no closing would I at the over questions turn I'm to to now time. showing Marucci back call remarks. Anthony

Anthony Marucci

Thank you, joining to operator. and for us thanks today. We appreciate time support. And your everyone

Enjoy at a As the always, the rest questions your any time. Have great welcome of day. summer. we

Operator

call. and concludes today's Ladies that gentlemen, you for Thank participating.

now may wonderful Everyone, disconnect. day. have You a

Celldex Therapeutics (CLDX) 8 Aug 192019 Q2 Earnings call transcript