AGEN - Earnings call transcript Q4 2017

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Operator

Good day, ladies and gentlemen, and welcome to the Agenus Fourth Quarter and Full Year 2017 Financial Results Conference Call.

As a reminder, today's conference call is being recorded.

Now, I would like to turn the conference over to Jennifer Buell, Head of External Affairs and Communications at Agenus. Please go ahead, Dr. Buell.

Jennifer Buell

to Results Fourth Conference welcome Year and and Financial XXXX Call. you, the Quarter Agenus Full Thank

cell update is or revise All evaluating the and law. risks recent business statements on When Commission. detail Before I without and made by to of potential continue, today's plans these in expressly are undertakes Agenus Securities and and statements technologies this the conference Company's activities, press our and its I'd speak potential cautionary they this as development portfolio the to like investors to the materially. will Company's of and to forward-looking remind statements and securities, no and to of give contain careful Company's the cause this and the U.S. are uncertainties towards separate prevention release clinical these statements, Exchange product disclosed the except a should to differ risks manufacturing could stream, statements, diseases and treatment the forward-looking publication and are by required in application forward-looking pursue in extent date and results including qualified Reference Agenus' of income of limitation, call to statement. more business trial risks regarding call considerations statements therapy through research and their you plans These that to actual the these that candidates only entirety data, obligation entity. These filing on uncertainties. and subject uncertainties

audio this broadcast. remainder call recorded a is for As being

AgenTus Klaskin, Head Medicine; Armen, Chief Officer; Therapeutics, Joining Agenus' Executive me subsidiary. of therapy Bruno of Dr. Christine John President and of Castle, Chairman Vice CEO and Finance; are cell Lucidi, Garo today Translational our Dr.

introductions expansion will During call, Garo financial provide leadership review. a and of provide update Christine corporate our will to this a team.

me let over Garo. With the for to open call then turn will the questions. that, We call

Garo Armen

Thank update. both us of you and Good defines to that for these. and quarterly is immuno-oncology. annual believe of you, future We a and speed Agenus morning on Today, company joining up Jen. set the presences and deliver thank as the on our innovation

Now you how and for during plans I do we the also let going our developments accomplishments and some about of review me tell highlights tell XXXX. this. are our for XXXX will you key to

is expression levels to of non-small can over XX%. the of clearly These Firstly, PD-LX with year, submission opportunity which This for our phase combination They patients very us. trial for Agenus cancer. first us a XXXX. last Keytruda, defined PD-X X patient is molecule launched cell significant commercial tested our lung and trials are to our antibody end first-line with we patients of Merck's antibody. have CTLA-X approval This AGENXXXX represent our CTLA-X a population by potentially lead in

proprietary trial dose We soon launched our Secondly, clinical also completed X PD-X line This as as these year, This BLA agents trial combination CTLA-X at and of trials support may antibodies our our major last in filing escalation we phase cancer. activity of reported a year. XXXX. second also cervical a we conferences pharmacological of combination biologic and compounds.

last we year. by discovered five developed immuno-oncology importantly, and advanced very novel and Third, antibodies Agenus

We expect to least file this INDs these year. for three of at antibodies

antibodies. to two including and IND many more by and cancers. treatments. Tregs undisclosed the to on immuno-oncology current our be the we in limitations is to Depleting will be for IND overcoming patients first next-generation depleting treatments designed Tregs Tregs many improve priming. immuno-oncology T filing addition bispecific more filing, Fourthly, critical cell CTLA-X our CTLA-X INDs will The to deplete Successfully next significantly market expand gen expect filed of

mechanism The the tumor improves immune confirmed response. first this been in these a has antibodies The publications. of for bispecific number for anti-tumor high-profile and of rationale microenvironment recently better

which developed have mechanism. via activity potent a this antibody has shown promising bispecific We

in second therapies, of be therapies, supplied The therapy enhancing Hence, microenvironment not important antibody Tregs targeted This the we depletes is critically immuno-oncology believe cellular we bispecific, this but for therapies, other radiation can periphery. have tumor efficacy in chemo believe and going therapy. to Fifth, clinical the potential. and blockbuster Agenus for west supplied and and launch earlier team. the achieved leadership programs in commercial in antibodies of CTLA-X have and to my XXXX commercial connection statement capabilities with our we – antibodies readiness our XXXX, readiness, about commercial our through our

it immunogenicity immediate transaction $XXX money and this $XX million with and first as we has proprietary payments. and advanced call only Lucidi This enabled planned the pipeline cash contingent safety and with allogeneic AutoSynVax, our our and Sixth, Bruno which significantly million a reported HealthCare our appointed vaccines. we targeting believe be we neoantigen ASV we own targets studies way are by facility proprietary cell of launched we CEO, Combination could years today, containing ASV. in portfolio our of our key royalties you subsidiary. antibodies while vaccine tumors. ago transaction for therapy netted which Seventh, completed manufacture. $XX Royalty QS-XX with us capabilities solid our our AgenTus, our synthetic of speed million expanded with also XXXX. cell in and eight, we We format increasing phosphorylated addition checkpoint financial our If from non-dilutive GlaxoSmithKline, us of acquired manufacturing in And three recall, us saving of of

Now, I for key will activities more expand on planned we have XXXX.

immuno-oncology and defines the speed and present innovation earlier, mentioned of future I today. As the

We not and targets, be sale and To capabilities internal rapidly. It be need requires must deliver done the a innovate continuous. both. generate to all are the It to of to is molecules, quality And identify challenge. engines manufacture develop on products. these one-time high set up lines

with all have to in-house speed. third-parties. limited dependence are We critical capabilities these on and innovation All

antibodies four we and two took years, neoantigen from clinics. the For to example, vaccine in discovery the past

next into the in five We are novel XX clinical the advance months. antibodies positioned to another

advancing we initiate will Lucidi, Bruno expect first of to the To our optimize proprietary Further, expended we our our set CEO with from antibodies We triple-combination of manufacturing programs. own own from therapy study take are proprietary we antibody for and launch of vaccine product our Last proprietary CTLA-X records. upgraded of our XXXX. hear clinics to our our of into PD-X capabilities. cancer of our antibodies, and the of and as with set the treatment first We in both therapy clinical rapidly commercial readiness, combination year, half took for first these our AgenTus expect cell trials a cell anti-CTLA-X launched industry own our PD-X. cell We and record as into first-in-men lung a first-line speed our first company, Keytruda you our time. non-small in anti-CTLA-X combination

to have we with PD-X. We produced recently grade the commercial three next commercial grade expect do and months, same CTLA-X in the

will materials our these well as of programs supplies collaborators. Our support as of our programs

all the Over clear desired A past year, it pharmacology. not are of PD-X been do antibodies PD-Xs show not has number that same.

different compared to clinical We this published reported PD-X has to that year PD-X, this active and many durability been responses alone have as tested. Separately, adding desired our of that rate that shows earlier AGENXXXX expands indications PD-X therapy activity. response for PD-X CTLA-X an antibody data clinical is with

Third, combination. this our and validating strategy we particular are clinical combinations in for

this three our of earlier, for at four, INDs antibodies we least to expect mentioned year. novel As five file

be filing our first The CTLA-X. will next-gen

I to have treatments. our published Tregs scientists is of mentioned cell a as and I-O enhances deplete CTLA-X earlier. of this discovered be review Tregs that designed rather Our novel finding function again, CTLA-X. in a is expected the critical feature, peer mechanism This Once T to to limitations T depleting overcoming With current the is improve cells, shortly journal. priming

as as lymphoma compounds with intratumoral can as by solid hematological condition like the agents regulatory tumor T which way. share as Additionally, selectively escape tumor mechanisms address These well in common tumors our tumors well B-cell solid cells bispecific the deplete escape mechanism tumors microenvironment.

As this mentioned are programs and next-generation year. antibody our to earlier, filings CTLA-X IND advancing bispecific

with delivering adjuvants rapidly unique importantly combination programs antibodies, fully-integrated flexibility. differentiated capabilities optimal very in treatments cell immune allow and position cancer Our and the therapy in vaccines, flexibility us along with our

platform Lastly, antibodies. in additional immuno-modulatory novel and a throughput to genetic additional we developed genome screening wide bispecific identify targets XXXX, novel high

to turn Top-tier banking about relationships our with have in interest financial firms whom had equity first. to we words A potential few plans partnering previous me our offerings. and let Now plans. gauge have financing approached us

of We on several and these interest our any shareholders level on interest such the and the company potential based transactions to on We of think partnership have near-term. transactions. coming dis-heard quality our considerations concentrate in closure to and best the of near-term it is for the

end, and of of we us our to so collaborations Turning our strategy far platforms our Merck. agreement to expanded core technologies. In To delivered In sales. let and GSK, million about antibody announced milestone a now that maximize receive eligible and worldwide say payment product strategic to XXXX, Incyte closing, of our a we successful few plus transactions, on up to advancement undisclosed are Agenus, and license under on additional the collaboration to portfolio Merck with extensive value partnership and have will allows are teams. words of $XX milestones resulting royalties research to in me our

and China of Lucidi, meeting on parties Pharmasset, founding the Tyler appointed PD-X mentioned therapy We as have of first immuno-oncology with expanded Bruno AgenTus who mechanism. cell capabilities They which update cancer Bruno our an vaccines. respectively. the an right years Chairman was acquired a Curiel, over extensive development the our added the $X billion, was will team. our have of in and I has and expertise introduction, interested me. We industry with AgenTus proud more is currently approximately who and Bruno provide now it built experts turn experience like on to leadership am after Idenix brings include By biopharmaceutical and way Therapeutics, newly Bruno, Merck in far. who publish – the subsidiary. of very and update XX will concentration CEO CEO I our and provide this, on will drug impressive we than With billion I to in for of were pipeline Bruno? team, Gilead heavy of AgenTus. so on later Bruno $XX by

Bruno Lucidi

shareholders. Garo and no with Jane. life-saving you, for and to created for Thank has glad value significant Cell shown very left therapy be potential patients leading option I'm have actually AgenTus.

ability logistical AgenTus the very they as tumors, and capabilities production. However, know, substancities is have high those manufacturing limitations shown We all largely currently you can adopted believe address therapy have cost hematologic to also and limitations. and restricted of they a technologies cell challenges major have and potentially

T solid proprietary generated tumors. TCR receptor our designed has high-quality libraries cell platform to First, target

thereby proprietary cost. and can formats addressing scalability and challenges manufacturing address Secondly, logistical allogeneic

structural discovery novo and proprietary our in efficacy de to off-the-shelf unique safety our potentially platform, bioinformatics, combinations curated compelling cell of of capabilities and Most optimize antibodies benefits agents improve conditioning biology, with develop to core is patients. library potential pipeline to computational Thirdly, tumor microenvironment importantly is an and validated biology the access also bispecific and phosphorylated of advantage designed first-in-class checkpoint agents mechanism. to molecular and rapidly with

that provide lead substantial our to We advancing collaboration. of are patient has value to call shareholder of team. pipeline team, for and lead opportunities. advancing I therapies our to a potential part that AgenTus by our we and excited our experienced programs highly talented AgenTus and and great differentiated huge believe I'm patients

turn financial will provide to to I Now, Klaskin update. over Christine the

Christine Klaskin

bond Cash XXXX. received net royalty December of $XX approximately cash year, proceeds at of XX, to Bruno. Agenus $XX.X from the equivalents the restructuring. million and you, million our were end Thank Subsequent

same in third share used quarter, the operating or For during for $XX reported quarter of $XX year-ended of activities December net $XX.X $XXX.X million per the loss for period activities per net $XXX XX, cash about the was The per Cash per a share. compared incurred the loss fourth in or XXXX. XXXX. share million a million This net to the net XXXX compares million, a compared the fourth quarter, loss company for in compared million for $XX.X with our million $X.XX share $XX.X was was XX, Agenus' $X.XX of used while the or in ended million of loss year with approximately the $XX.X ended XXXX $X.XX XXXX. of $X.XX year operating for million to quarter December approximately

Garo Armen

Thank Christine. you,

turn will operator the I questions any you Now, to may have. think, for back that I it

Operator

[Operator Instructions].

ahead. with Please Our first Securities. go King Mike from comes question JMP

Mike King

taking and morning for Good the questions. thanks

question. for the AGENXXXX there ask study Sorry sort how coming are to the to just of will CheckMate the AACR carefully of about a you, I prudent noise. going you of be weeks the and in or looking of wanted that study see you know your resize requirement be background results maybe at couple judgment to to is That's if first pembro? just any -XXX

Garo Armen

it have we why question we strategy very to strategy, to looking our with carefully to So, of all specifically. have we at previous the on clinical – you will trials, know the as that define expand you be that? answer Jen, don't is,

Jennifer Buell

risk top Thanks Keytruda Mike, in the are out is looking line thanks I Garo. be we'll something agent of an the I'll we selected an remind indication diagnostic, results. probability where a ensuring Keytruda. for about taking And on patients based high and just question But certainly success. spoken and regulatory just wanted AGENXXXX very much our to approved is for first where that reiterate you thereby before these on ling and technical are we've approved of removing

of and and durability on that coming has higher XX% the recently a active. colorectal add results rate out response. ASCO the host in lung seeing where AGENXXXX. and We anticipate, data PD-X rate of expect see population is increases of TI, rate response the most Keytruda response a CLTA-X We add-on the that our With know we in patient MSI-high significantly that response we cancer our the now of a with

we'll that the So, sufficient forward. believe sample landscape competitive as certainly go have be monitoring the today, we but we we

Mike King

potential Maybe superiority, you numerically win what's non-inferiority, you of – could that know favor you for I showing provide you the if you talk are lower, both various say advocacy tolerability a better profile? Is sort guys? but can if that let know you bit you, about Is wise a outcomes it if discuss you? know win? then, how you do don't a a

Garo Armen

at So the crack take let me first it.

to Let our improvement in me strategy, not a we line on context non-small that cell What regards of our hence, a get you do to is to with our agents, tell will rapid marginal delta that much to and of doing not add looking commercialization everything our single is What the a the are the a you on not believe and timeline. that? prioritization anything That Jen, of want marginal lung all is not with that you what pretty kinds today, on That a in is just win? as cancer differentiate trial, company Because in a but is in win trials outcomes for first improvements a efficacy are we of combinations. put we efficacy. safety. win. is us will preoccupation, significant not do foremost us the

Jennifer Buell

that you questions. I think covered it Garo. Mike, your hope addresses I

Mike King

for toxicity concerned, as wanted out adverse terms you I or in It of is does. should be but on words We'll publication. increase can Checkmate concerned about obviously CTLA-X. just follow about quick said activity the also advance to else in for the figure look, your -XXX. of – as investors how the novel exactly were be far But you potential improvement I much in, what be I in the events. don't going know maybe it's a as published so Garo, everyone up will talk the know

Garo Armen

I mean want as adverse things always, don't and molecule, Having the But be details research quite and you compound have are on well a you we cannot watch as for that, may an terms a with more both reasons that clearly said one, have its to we expansive. upcoming on publication, hurdle what and a IP our certainly. this that fact activity, just you So, capabilities for elaborate give we as Mike, to jeopardize know of events. of couple in this; new

the way these rapidly very potential also a in molecules ability that candidates generate design to into properties and risks. have very minimizes We carefully these

design as of next-gen them, both eliminate efficacy optimization CTLA-X never effect. but to well the antibody I-O molecules the minimization as You of bispecific address these side both are can of and

our Now mentioned one of as I intratumoral of before, depletion dose for Treg. example, bispecifics,

able but more it Now, to we a like other safety big this Treg do issue, you'd the you is think this our this, first-in-class broadly Jen risk important very John, intratumorally, issue any and if you it you add the is very effectively. advantage. may please? if a you issues, and Hence important to gives because to best-in-class to yes speaking, deplete molecule if color do be

Jennifer Buell

thing publish one At particular Agenus, first this we mechanism. quite mechanism. add believe the about because am just this on we'll be I'll I really excited to

for may get an to first at of them. think looking least I of dose it we it we current with the some generation in is to it a at be lower dose something able future we certainly that to we engineered What will optimal are antibodies the the into may what – antibody Mike, likely than made see and change our that are some pharmacologic CTLA-X. be achieve way

need about as validate we visibility that So we'll quite to that are possible soon but mentioned, as Garo again, enthusiastic in sure clinic, really and as we get it to publication. that will the make you'll

Dr. John Castle

I Garo going the and dual very we increase think As so going just in pointed effect to looking to publication be well. of looking both be priming It's forward is depletion to to reiterating Treg out, the also that. are essential and the as at

Garo Armen

Thank John. you,

Mike King

Great. just But I or AgenTus, and timing sort question revelation your And talk therapy? know of – Thank targets one about It other you. set of the you apologies to might exciting just if wondering sounds first for guys. target want of this. quick cell what your should then on

Garo Armen

address discretion. question to Bruno his let at will I that

Bruno Lucidi

be quarter this information now, the believe some know to cell therapy. disclosing May, time quarter about third are during some during should that in second We June. not we you starting our – year, For we disclose any information the

Garo Armen

Thank you, Bruno.

Mike King

Thanks question. for my taking

Jennifer Buell

Thanks Mike.

Operator

Phipps go Matt William from And ahead. our Blair. question [Operator comes with Instructions] next Please

Matt Phipps

off taking now maybe then could talk your anything about or to I single-chain there? variable for was platform. fragments based you for first, question. if antibodies, can Thanks I guess whole Is bispecific full size this guys. of my you disclose Hi wondering

Garo Armen

Okay.

I proprietary So, tell using one thing traditional you not platform. that that we're their can is

our carefully ability target operate very where to bispecifics the regions, engineer relevant engineered based examined freedom as on as the FC our on we domain. specifically So to our lies that and and based well finding

We unfortunately I are which discussions, of reasons. that confidentiality, as you, have bispecific partnership of well our they can't doing become because even reasons the but to at experts competitive disclosed this, for as and fact

Jennifer Buell

to to available related am add going chance to I the had publicly this, one Now We've on approach. thing. a information just discuss our

We ability to combinations. to capability have optimal and a established be able identify throughput high

and essentially, know works research freedom that essentially we are feature that our some identify And differentiation I platforms. what may. own has is is. collaborations it for platforms we But an those to to to exploiting parts unmet bispecific molecules have know leverages what the combination actually platform molecule that and We to to us us operate best target that optimal and and where the we that's that of that a so think life the that major do then capabilities. development. address that's And area We allows agnostically less a combinations novel proprietary for creates need the of bring is the critical if moved novel

Garo Armen

you, Jen. Thank

Matt Phipps

Thanks.

moving So I AGENXXXX Has now completed cell. Keytruda dose point? with at non-small this on guess to, escalation

Jennifer Buell

completed escalation. Yes, it has, and dose

Garo Armen

regimen. the the optimal So dose have we dosing picked and

Matt Phipps

biomarker needed how in will margin you defined so be patients to of data And set generate this the to population? a FDA to go many patient think do

Garo Armen

Okay.

our of in a question reasons, about Mike concerns disclosed. rather data do and delta trial, also be this for we what what competitive haven't the consider will assumptions our success which success, – we or considered earlier benefits asked on significant with based So when

to numbers, is work if delta out we quite and reasons reason. want happen the this. the can That's don't give of patient So, and figure one we for will competitive that one backwards what be I that on you

Matt Phipps

Okay.

of KEYNOTE-XXX trial role with recently regulatory see people and Merck that a is first non-small or landscape So PD-LX playing a which How discussions? positive of patient the that XX% competitive lung XXX in pembro cancer. started and Yervoy kind cell you

Garo Armen

longer Based on trial is maturity ours. for than public information, date that the

be assumptions So, be But maturity enroll. date. their how enroll assumptions, later it than their and quickly maturity will quickly somewhat versus with on they our our contingent how will date we

Matt Phipps

And plans there? Merck KEYTRUDA all your target review Thanks. Okay. a rapid you there development single and development. was plan in just for got then of cancer. agent kind indication Have know I guys at also what's the changed combination the of priority advanced that lastly, for wholly-owned for one cervical

Garo Armen

will start, if let So me like. elaborate one, she and more Jen

that's the combinations So chosen clearly, reasons of believe by will and one the And margin, some cervical we've that in the we cancer chosen efficacy exceed strategy. a combination the indication of single-agent. we've

have to And happen, should important that's So, advantage. competitive will Jen? we an our that key then, assumptions.

Jennifer Buell

actually We their Again XX% And generally tumors where cancer you rate right. response validation excited see of that and line of response see of those very this that we in you response. is addition what second higher CTLA-X is know HCV and we those That's tumors have burden, more the were cancer. similar induced, mutational know one cervical otherwise course of increases And durability this rate. to we PD-X with tumors PD-X higher have is is than cases. of response of largely the the HCV-induced indications, active, PD-X, but to cervical

only to us So validates programs. that we opportunity may this that help accelerate our strategy our an and believe gives

Garo Armen

Unfortunately, need we we time constraints. have that, call. to the end with some So

ask have I operator so, will please any other us And separately. much. contact Thank you questions, if very up. you the to And wrap

Operator

conference today's you attending has Thank now The presentation. for concluded.

disconnect. may You now

Agenus (AGEN) 15 Mar 182017 Q4 Earnings call transcript