AGEN - Earnings call transcript Q2 2021

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Operator

Good morning, ladies and gentlemen. Thank you for standing by and welcome to Agenus Second Quarter 2021 Conference Call and Webcast. [Operator Instructions] Please note that this event is being recorded and may be used in future Agenus promotional material. I would now like to turn the conference over to Jan Medina, Director of Investor Relations. Jan, please go ahead.

Jan Medina

thank for and us Myra you, you, joining all, today. Thank will is on being call be webcast Today’s replay. and available for our website like and our that statements, I’d as well commercial you will for timelines, remind forward-looking data timelines include release plans this and including opportunities. development, clinical call regarding as regulatory partnership and statements to details statements our SEC to are refer we you subject These for to on more and risks. risks and uncertainties these filings

broadcast. is being recorded another As this audio reminder, call for

Dr. Chairman Armen, are Executive Chief and Jennifer Operating Dr. today Klaskin, Chief Hurley, Officer; me Joining Christine Finance. Garo Chief and President President and Commercial Buell, of Officer; Vice Officer; our Andy

turn during I’ll highlight call far. to Garo our XXXX Now, progress over Garo? the to so

Garo Armen

us the to named Thank you very much, company. Jan, and in joining officers the today, of thank for you, addition everyone

our have by terms. also that questions I may We Medical Chief Steven what we in weeks our tried displaying answer explain I Meeting will Dr. Officer our the simple to any to at business ago. And have Shareholders end. start approximately there at eight you O'Day, did

major the we there’s AGENXXXX of that we updated second our about in future that conference. year, already heard supportive clinical many about on So AGENXXXX, our of be the And that’s well Starting our hear program, least And major results that focus our at creators this beyond will generation which of clinical made have have is over have. just occasions value our XXXX, as the one with at significant patients programs trials. does. what you clinical you’ll and enrolled And half drivers, with is data XXX what available in before. key operational compound CTLA-X on next clarity some we CTLA-X the

driver, our value about at significant talked cells. which program, is iNKT Shareholders which Meeting our is we AGENT-XXX second the Our

offering. proposed SI filed much we that, Now, have a cannot because about for we public an say very

is driver AGENXXXX. major Third our

Now, this agonist. is a XXBB

compound. has safety call the CDXXX. And activity. excellent this very seeing gotten shown the of QS-XX lot course, we’re has have compound, of with tested second half critical our more a in attention This it of also a headlines which you’ll been other we profile. about hear what’s compound COVID. for has early been for in And hints We of year, last And the what which because almost program, of And year, of vaccines this can now do COVID prophylaxis. beyond this because

on very programs prioritize, Now, we as very the the you transaction. which to know, a we Bristol licensing compound. bispecific do of of was bispecific is early and the course, fund a this Myers about, these exciting our how programs? beginning arm we often And important in It get questions of quarter, yet. TIGIT disclosed That closed has in been not and on

We one to transaction, consummation have the if disclose a thought advance process. competitive that, also the our of the best candidates that best of candidate. that was Bristol we is program, of it this at And time not this

the get already $XXX million, to received. So us which this transaction allows we’ve

In a have addition importantly, worth transactions number queue. in payments, a of well potential upon there of the royalties over billion milestone very But to and are also, we commercialization. $X other that, contingent

And some beyond. second some the year, may happen of and the this of during half course

be company. also Agenus therapy This Company. potential own. on are IPO talked we AgenTus may the from remember, MiNK that is we And anticipate about you cell businesses a spin-outs Now, filing MiNK, those of and other potential with to have been by the talked about We is for way, our original proposed SX cultivated also for who ready the their for spin-out strategies.

on plan without cash, additional potential portfolio. also to of Now, license strategy that a our about programs particularly project to in as we number in are bring necessarily there such them. And ourselves a talked pursuing for having financings we’ve programs

will that the we we’ve PD-X our may programs. today. with it elements our our conference we what not be antibody, very that on in of Now, about balstilimab be connection major blockbuster product while medical at announced zalifrelimab, some our portfolio. said also category and that as our blockbuster balstilimab, its which mentioned, other antibody. call plus programs were we talked third potential, PD-X soon, supportive earnings the We’ve in And disclosure a potential about certainly And with include more own you a supportive well, a can hear

for capabilities, to And discussions meaning, been of people’s us earlier can us CTLA-X PD-X those some CTLA-X other in our expanding in first-generation programs with be assets which in spoke hand connection one synergy that PD-X and fourth the the compounds rapidly. these our for antibodies. we from market well for will our benefit these Now, operational advance valuable as benefit we’ve clinic by potential about, are and provided zalifrelimab, clinical assets, the will collaborations combinations. further allow by on also as with balstilimab, combinations pillar very our key very The

briefly. own also other candidates, Andy to Hurley us product will manufacture is our they be the allow they allow reliably be to to And thirdly, speaking able us launch today that On and about hand, rapidly. our Dr.

Buell. Thank I Dr. Jennifer call you, So with Jennifer. will that, to turn this

Jennifer Buell

filed progress. review as for for critical BLA now we these clinic, December you a to I’ll become unique research past now in date Garo. for really usual much of Agenus the to is bit those remarkable application, XX. also which advancement us build make our our little Garo But mentioned, have with first we’ve an upon what Garo of productivity, programs, delivered is new application really been has FDA as balstilimab, we’ve or by filings business development accepted as just program six years, Thank the which discoveries action addition mentioned, to very and the was in priority XX

that commercial progress quite our months, then So, you as tell O'Day Dr. up been course, and Andy AGENXXXX balstilimab zalifrelimab quite excited has we’re mentioned, for of for will to data build Garo as we’re beyond and in about upcoming from remarkable. now the setting you hear infrastructure the

Andy the support for to set that be going AGENXXXX. well So and building launch up the us infrastructure is will of

advancements of the addition discoveries teams a the AGENXXXX. those to seven to these discovery is one and advancing clinic announced In that during clinic,

have that’s molecule, in this Garo IO bring quite company we’re most Now advancing now is a to that the this collaboration and in plan components few to an they forward. very really aggressive development biology, intuitive important Bristol. They’re And really TIGIT remarkable experience space Bristol bispecific a is about. which in with mentioned committed their it, a excited strategic and

strategic this in In addition, in from collaboration with the the have to which differences combine our marks portfolio, our prior is we agents exciting certain opportunities bispecific really for some collaborations important us. that,

to In opportunity addition, upon the have co-promote. we approval,

IND the really FDA molecule. making of this and about progress clearance announcements of further recent we’ll we’re forward this excited looking So, about to be the clinical

recent has be specific in Now, expect now making beyond which on we will been AGENXXXX, data data, disease that present And data upon these that most to we’ve release upon. mentioned Garo those that based progress the cohorts, advancements, is cohorts clinic. expanding significant

answer, Dr. program. have an we we’ll questions us take about and So, here O'Day, today this we certainly, with

PD-X, Additionally, this at and when we have with see – we we others shown have you as AGENXXXX. the ask CTLA-X

cancer cervical We cervical response. in zal of response duration and we’re an this patients one with with most at cancer. our update this year. programs bal-zal to see in advanced particularly expand also refractory really program rates be And on plus our We excited clinical presenting in of about ASMO

presentations quite So been announced the have enthusiastic now a about. oral titles have and many we’ll

Therapeutics, program what a for what can Now you – can’t these about programs, introduced confidential I MiNK say on IPO. we’ve is, this this, we Garo explained submitted Well, a this, much too we’ve say to SX before. proposed

also a tumor NK killer cancer the Therapeutics is through cells of MiNK and the and cells. ability They modulate capacity cells of their that T invariant MDSCs. lysis. subset have in form the natural power advancing directly microenvironment. these believe AgenTus responses cells. T and cells, and activate NK adaptive with of They carry recruit deliver cells T to allogeneic and Now, to kill they the T in the to modulate immunity. They potential actually have T formerly innate suppressor both tumors memory suppress We myeloid-derived cytolytic durability tumor cells They cells, are

tumors where announced with underway. multiple will the modulating add addition PD-X. with in cells CTLA-X from evaluating these exploring And with programs these PD-X. can We’ve to and combination clinical alone believe checkpoint programs on build preclinically. cancers. solid include, We XX% along those, eradication into we’ve antibodies, solid iNKT patients CTLA-X in tumor preclinical trials PD-X that CTLA-X demonstrating and validated when these be have in models and these data the as you combination also progress about cells the such are presented in into cells We previously those complete active, these cells we’ve and model into XX% And seen cells that benefits taking and that you see that

interrogate in secondary year be biology. respond platform, is these well patients will ARDS a presenting on identify, our a us enables severe approach we’ve best will expect who tool number into to that us to we as data So, programs cells molecules therapies. multiple VISION to ways patients platform data patients, this times This to we with responses, which ongoing in patients our to And and also our in, identify be can as address is on finally, COVID-XX. this enables this platform the of how later clinical design with presented myeloma, to predict

patients therapies the our new therapy. respond patients combination probability platform identify be capabilities our an to of platform We we those forward to expanding platform. determining look to the of evolving to is want will and significant before of who continuing expect update on able you progress compute biologics to This and with this who and

Hurley Now, it over commercials. turn to tell going to our about you Andy to I’m

Andy Hurley

we’re Cancer, Thanks, making commercial Jen. that launch report the ACC Cervical short. great Advanced for the I’m U.S. balstilimab happy progress in of to planning

hired the the pleased and plan. company. launch attracted with a continued has to team only the commercial strategic team a highly a Agenus part and agility medical leadership experienced top it have as and the the be and and and identified A have to of commercial launch industry develop defined of leaders across shown well medical driving that We and from tactical the functions, build across we the collaboration strong out key is very team to as

in in for goals Our launch mind. two ACC planning main has balstilimab

First, benefit that that has with few from balstilimab every patient it to can barriers. access

our from to will to physicians bring a To the efficient this cost ACC determined, innovative And be are in to pharma launch in the will they often physicians. future. eliminate comment on that or directors how market leveraging and promotion in information of and face, how with launch. COVID at medians team reimbursement and we progress hired line personal And We these have made launch we challenged account a physicians in now pre further learning’s trying an market their will to a medications. planning, launch leveraging And commercial to experienced we at launch support and newly told when coverage provide how channels we us, every normal research. of payers potential, reduce second, be programs widespread prefer bit receive want approved promote think, market. education hurdles have balstilimab its formulary balstilimab approach leveraging engaging to products our to non-personal leaders, physicians the across that and with that medical targeted they company including

us extensive that to deep launch. across We able stakeholders. infrastructure key to research will audience determine to a not act and a to to product and react physicians data and or for and insight be hear where enable in for we signals I’ve lot payers that and messaging happened a We wide of market quickly real management agile, in This is on launches built an time positioning fast generation fail, seen have market. at insights has a that allow all being conducted our

and silos spending deal of that launch no We ensuring time our are we there execution. support how a great are

following vendor and our balstilimab support creative support be to We partners they teams, in with campaigns, also launches will medical can have industry our hub, CRM planning, vendors platforms, so future these ACC. marketing other within education and agencies And launch in embedded critical partnered best the reimbursement areas.

systems value as a turn of this of to be initiate to step it goal is overarching fully commercial the Agenus. in us the for easily foundational the the operational will However, of integrated pipeline. serve maximizing launches, would a for our and to for future allow launch scale our infrastructure, catalyst It teams which build vast

high mentioned, that in as and indications possibilities big with are AGENXXXX excited for Specifically needs. we Garo Jen unmet very the

our career. second launches monotherapy IO turn a history. got the As to is results. and life the that promise that of hope in Cervical a providing of Agenus. patients, potentially certainly ahead it could see a exciting good population commercially outcomes, broader seldom review Klaskin XX range to come financial AGENXXXX a small and to offer me believe could it have clinically over option. much are I fortune part we as AGENXXXX seen There reason of of patients Advanced patients is I’ll for Cancer We Christine potentially the to And over recent my times much in big has I’ve now Agenus balstilimab career. a range to of what cancer help. and in the outcomes had led therapeutic changing to been with product line, unmatched a

Christine Klaskin

Thank $XX we partnership. cash XXXX to December million as ended $XXX second compared our million We XX, received to the with of Andy. at related to $XXX balance you, of quarter the quarter XXXX. end, BMS million, Subsequent a

$X.XX of of XX, to the and we for share. same in XXXX. of reported XXXX quarter loss operations million used million, was or in XXXX, a the Non-cash net loss for to operating used second $XX per were compares cash second June million, ended a $XX in $XX the June second cash ended compared XXXX quarter net operations For million period or of quarter This the for and $XX per share. our $XX XX, $XX $X.XX million, expenses million

$XX under of $X.XX of and for in XXXX the for loss per million period $X.XX agreements, net revenue of This revenue the we $XX used cash months operations XX, $XX Our six six revenue upfront million, compared We loss recognized million XXXX for $XXX per $XX used XXXX, from turn million, XXXX $XX June million share, operations in non-cash XX, or cash same the ended collaboration recognized earned, Garo. license million, months in ended of our a the or to with share. with a June received. – call includes royalties respectively. fee million I’ll in XXXX now related and an to back $XX related revenue and and net

Garo Armen

questions. our a thank turn you very again remarks once participating the call. make for before I closing to much, you will And for will in it Thank Christine. few I operator

Just some the summarize, for of of that you the second half to year highlights this may expect.

diligently PDUFA As final Jen And aspects for date required. in monotherapy working the mentioned, balstilimab we’re or we is December. for of have what a preparation all in phases,

said, launches. mentioned, putting for diligently as future second infrastructure, on leveraging Andy for But preparing an so our for cervical that commercial line we’re can our we As you we’re launch cancer. capitalize together

We’re mentioned, the going presentation expect to Jen our strategy be at bal-zal. And the exciting defining for upcoming conference. as you ESMO can

to pipeline AGENXXXX. second also And an partnered and data transition our for a studies own our presentations We of for with study are agents to agents approvable the additional will AGENXXXX due continue in our development with strategy half. for

advancing TIGIT We through AGENXXXX, into now Bristol will our Myers’s asset. program the which and is the clinics. be It’s

will enrollment our filing, We will expect a on program us programs. other our in give which be based various quiet And period. iNKT the you SX not on what or completing puts we I confidential with specifics

antibodies. other very us in otherwise as or be as for aspect immunotherapy, will that Andy patients do therapy. matter, launch, This for any capabilities benefiting our manufacturing as important to strategy. not that who launch possible data, of potentially we speedily demonstration It compelling are upon AGENXXXX said, of commercial from our progressing for so be will We is can this, a critical

questions of open We’re prophylactic important we anticipating be transactions And, with which corporate sustainable you earlier, year. will now very for second of believe have. very, And as may your financial supply adjutancy. to we also is and well this we’re half vaccine QS-XX, agent in for any attention. transactions, a Thank additional all again our therapeutic both progressing the you as mentioned as I

Jan Medina

could Thanks, Myra, please. if open you Q&A the

Operator

of from Instructions] you. from Shi comes first Our Jefferies. line Thank the Kelly question [Operator

Please is go line Your open. ahead.

Kelly Shi

questions. Congrats the I thank taking you progress. for on my two have questions. And

second-line So, first survival probably data is, give question what And my from an given far have behind approval, mono are overall of commercial monotherapy That’s upon your cancer first marketing color in the my you versus that could strategy you. some us the trial? in also, data not ESMO? too on strategy Does combo? question. this impact Thank going cervical data is your what is, is a we at one second combo about progress? combo monotherapy the to median hear And for

Garo Armen

address the my we’ll a that outcome the to the it Let simply me into to specifics. and kicked-out Otherwise, presentation, be ESMO get I’ll we for specifics. which turn colleagues cannot very say the then much top-line, desirable not question us. of remember about But is very

Now, of see you first back about of that’s say the talking about say classified so with patient, you’re certainly, being getting to combinations And responses. And but I duration results, time; today with and response will data exciting. improved the as generally, if very also when very I’m talking know as than therapies, IO question, that. And the that generally, your I you typical rates, monotherapy. critically majority products better when existing great of marketed results improved better we’re achieve we’ve

appropriate the become and best Dr. that, you facts, the sure where allowing respectfully, population, including But U.S. options world, path these elsewhere if ideal would the available and the so we agencies other? any very accept Hurley, worked and imagine in and with Buell an hurdles, will there regulatory we would desired combinations the regulatory should practiced the have for are combination in forward. but combinations to that be hurdles, patient these these that everybody with So Dr. be make to for

Jennifer Buell

number Sure. it I’m to going your get question, on started to turn question Andy Kelly, to over one.

Andy Hurley

to I that and launch relationships, launches product at a monotherapy targeting to get to get foundation that bringing with for space. as those you the every build dynamics the launch have you, and for thank so the be to to Kelly. are going Yes, understand allows establish in be us to a subsequent looked needed understand really marketplace, community you’re balstilimab really particular to going

And comfort wide particular bringing balstilimab have comfort to may past, if part they So and is much our establish credibility they’re a combination to to because in. marketplace that with not really make have going And monotherapy other balstilimab. option, and with to needed strategy a first get so, is they’re physicians. a the step going to bringing has already to seeing of really and that the of audience worked doing we’re going therapy that work, good it a then significant and be in be looking a really us in it, for that where really agents impact

go that’s is, believe what it fact to that isolation. the I I the that looking So, is we’re really made launches in initial at and point not back I’ll

explore well presence to really looks as continue primary And versus leadership, as want necessary products be our at the pivot as cancer make support, and our both we’ll market. to have primary to fully the looking on one to field cervical not in-house to that integrated at that it focus; can the bring another commercial in combination whatever to we impact. we’re We’re a looking is focus build infrastructure able the then commercial promising is to to we

Kelly Shi

Thank you.

Operator

much. you very Thank

question next B. Securities. from of Mamtani from Riley the Our Mayank comes line

go Your is open. Please line ahead.

Mayank Mamtani

to the role Jen and new for the Andy, taking Thanks question, you have on progress and on particularly morning congrats when our call. Good team. in can that great the for to

questions couple Dr. a So first of O'Day. maybe for

question maybe should just curious of AGENXXXX, can like at just dot, after, ESMO, different of of expect versus, you the looks maybe in combination, we sort also MSS patients So of terms number may be on you what number this for doing it’s you number have it’s a tumor have update like setting types, that PD-X and in refractory colorectal would one. cohort, what

Steven O'Day

question. that for Thank you

better well agent, microenvironment excited We’re AGENXXXX which to CTLA-X view, the very priming regs a of be disclosed. as both obviously more in been depleting we’ve has a the point program This having from T and tumor as is generation toxicity profile. next about a as active publicly and engineered memory

we either So, X, as we Phase XXX AGENXXXX Xb treated advance the have or with now continue Phase combination. over to said, patients single program, Garo

cold sense say Well, generation it’s We PD-X data a responses, point. been the been at conference. as will historically like the colorectal and by year tumors, next think more that in ovarian, designed PD-X have to a no the this can’t be this presenting the be end at that, as hopefully the tumors we’ve date in as take program CTLA-X, little to major of to from And have it’s solid messages resistance home I than that we CTLA-X well such cancer, reported performing activity, had MS particularly stable clinic settings. or in this

publicly all But in in meeting. encouraging we know, released further you look colorectal doing in trial, is and that one forward but this stable expanding that, year. a that MS not at the forward rapidly to the we look you is of to us. are later updating cohort that very major on as to this And again, cohorts, terms updates cohorts numbers So have of that around

Mayank Mamtani

are monotherapy experience expecting then you for for chance? that an you draw And details. you that, instance, are any parallel Thank all have AdCom from, with the on PDUFA, prepared FDA, the there any or retifanlimab by should for bal recent a

Steven O'Day

The question expecting we is – are date?

Jennifer Buell

AdCom? In

Steven O'Day

AdCom.

we’re through now lot think details. you to I right going And now. think process, of going of out not between disclose that work can that of process. agency. communication will inspections date, all we in respect the mandated the with a in the There I expect Okay, and are do PDUFA to And we the are the

Mayank Mamtani

and you patients color territories able a sort maybe iNKT fair been dosed follow-up are what then ARDS, enrolling for COVID-XX of tumors you I and Garo, Jen, for there? any solid the comment And have Okay, to have Jen the you, for sort of and maybe across enough. on but

Jennifer Buell

Hi are Mayank, in process. as we’ll for too be with been right can’t where we aggressive across given data the the portfolio. say reasons, we at assure, rest now we obvious much have always But releases

Mayank Mamtani

I’m a see coming Garo, this you California, at facility scaling Great, here XOMA for thank as going think CapEx, lot But Garo R&D just R&D, you. curious, about if how should online that this Vacaville QS-XX becomes CapEx across look would And continuing G&A expanding about how in to like, maybe require antibody forward? would great efforts. expanding think and up something obviously, Especially you we investment, adjuvant your the pipeline? to find

Garo Armen

Okay.

address I So, complex ways. several to bear me. And let me that in just mean answer, my with but don’t about be

of Now, in have Mayank, quarter, if how our cash at at our well. Meaning, orderly history, look has way. our a expenditures done cash given been very very cash versus you any we balance? we have It managed managed the and outflows inflows

in to deliver have year, Bristol is bit expected the Of and jumps has balances. $XXX in our brought milestone cash balances. that into expect of a of second will we cash another in jump this I year, And additional that cash the million course, the of in terms provided half a our transaction infusion,

In they transactions. Now, from milestones, several corporate addition do to transactions, come project sources? where financing

businesses. assets. infusion, related includes and includes That MiNK means subsidiaries QS-XX outside cash, example, to our of our we some asset, for expect will of capital it those, In our of addition separated that by with some certainly those reduce fund also this Therapeutics our cash burn and associated to

the also second of this expect see to asset can possibly You some sales, in year. half

But be. that basis represent all so with of can from promise be each of manage cash add And to are will to period. we’ll you that position things, will at if able relative a left jumps, what impact we that I to you cushion so occur that end the on unusual time those our will quarter-to-quarter substantial expect that items I the time a

that, So more other give guidance. I unfortunately, you dollar than any specific cannot

Mayank Mamtani

No, taking questions. again that’s helpful Thanks for our color.

Operator

Phipps line from Blair. from question Our [Operator William Matt the Instructions] comes next of

is line Please Your ahead. go open.

Matt Phipps

morning. questions. Good Thanks taking my for

of filing? we the to few, you a that clear. the bit Just have on bell give have bal of any Just update can ahead do that guys bal-zal PDUFA on clarity little a for for PDUFA you to more wait really timing the

Garo Armen

guidance we’ve we’ll this on think filing, that bal-zal the said the provide year. in half I Matt, that of second

combination with course, function the going disclosing deliberations the be at the and ESMO, that data data and to trial FDA. then it’s Of final from a us of

Once some processes So clarity the PDUFA give bear you regard through what with a to the us. path But the both with again? we get will on was forward. question definition date,

Matt Phipps

No, that. move plan antibody, are do Or now after Then bispecific? the monospecific outline for for owned asset wholly into AGENXXXX TIGIT that’s into answers thoughts pretty still just much secondly, what to the the you X that Phase this year? that

Garo Armen

the we’ve has And over suggestible. clearly, it’s very So bispecific advantages monospecific. the the data that generated so far,

is you of have PD-X can combination reagent? an reagent, like some the an possibilities important the is answer important most that, be portfolio, For just the yes. said antibody having However, monospecific likely, other

us, And but period IND guidance – we don’t be will I and within we in of on program this advance mind, with it with reasonable timing a the bear so the exact time. provided of hence filing, that we’ve think

Matt Phipps

are then also are kind you of do in a – I realm. moving kind direction TIGIT, then TGFß pipeline then disclosures, kind TRAP that that stage therapies kind does And at obviously, it more Okay, there’s move to look you of that formats thanks. the really earliest and that broadly, Garo, a or seem of bispecific you’re think a is bit like of of is mean,

curious platform? where just for think kind about that’s evolution of the if we of antibody based So should your of kind

Garo Armen

Matt. that, you thank I for

exciting that be to as say And phenomenal year. the have specifically versus will agents, is clinic we very know, not agents enter agents. seen activity that been have disclosed, Meaning, will assumption. also activity that’s bispecifics certain with a one these a on. in filed of But portfolio of activities. most think early have is of presumption that the this to monospecifics But course, agents. I and you as seeing system that exciting that process Symphony some announced, yes, I the activity of being with the very, fair have we’re be think single we immune And, our immuno-oncology have a it’s lot Symphony like very

And so I portfolio think we data, using seen our have generating sue, and from our technology exciting development it as will combinations for VISION will be and own very see process. very in us preclinical other exciting our be that means to

and because will. we Symphony, very components particularly you the the So exciting exciting, of different control if very

Matt Phipps

this time. are There no Garo. thanks, questions at further Great,

may You continue.

Garo Armen

attendance Thank updates. you for very and our much listening to all. very Thank your much you

Operator

concludes today’s conference This call.

day. You Have a great may now disconnect.

Agenus (AGEN) 9 Aug 212021 Q2 Earnings call transcript