AGEN - Earnings call transcript Q1 2021

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Operator

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Agenus First 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 John Medina, Director of Investor Relations. John, please go ahead.

John Medina

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

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

Joining Dr. Buell, Chief and Officer; Steven are Vice me Officer; Chief Executive Chief Klaskin, our Dr. and today President Chairman Armen, Garo of Officer; Dr. Medical President Jennifer Christine O'Day, Finance. and Operating

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

Garo Armen

in and data, XXXX thank participation trial slots this additional John. for a our progress BLA, the you, all the for advancing strategy key transactions call, our In Agenus. make our iNKT accretive and and for defining and include in X.X have milestones. you our corporate your quarter. our start clinical weeks, COVID past since and on ASCO, programs we cash with filing last at Thank current for morning, earning Good to interest continued everybody, on first track presentation being year, two cancer, in programs These

treatment for Firstly, pathway. metastatic we under announce that the accelerated Balstilimab of recurrent approval the or BLA we FDA submitted our cancer the to cervical

the CTLA-X had inhibitor, steady antibody, disclosed disclosed. been generation trend at there next we this continuing new meeting previously impressive our regarding for April, results we and AACR responses Second, AGENXXXX, the annual clinical in has

presented Additional at data be responses and upcoming conferences. clinical will

with in our cancer, our indicated checkpoint program, distress iNKT our initiation advance we solid cancer in antibodies with had iNKT patients continue dosing combinations to program secondary soon while into with Third, acute cells development cell March, our and clinical initiate we’ll respiratory we the have announced tumor and cancers. regarding in last COVID iNKT recently first therapy call to we our XX, syndrome, of we extended patient in

TIGIT, we quarter. an lead IND expect efforts to bispecific, this current file expect to our Turning our anti-TIGIT – have program, to during and advanced AGENXXXX file for to

continue corporate year, Next the cash transactions, transactions quarter. expect to this accretive current starting we regarding in corporate

While of we months, continue the upheaval are has core there been around to objectives. over the world our our to last tremendous strategy. and with is delivery track unchanged innovations is will our and the be of quality and on Speed XX mission Agenus’ core

success to paramount the will resources our people marshal Chief call would to and the are the and to We I Buell? continue like that Jennifer Dr. now Buell. President Dr. Officer, best achieve for to Operating us. turn

Jennifer Buell

you, Garo. Thank

interactions by Systems integration. for VISION This to What This actually realized generate is our I-O part purpose? attributable short less is new immunotherapies platform, delivered is our technology is of respond and VISION? superior time, we've virtual purpose for and to than in a in efficiently VISION’s also offers targets. much validation empowers drug decision same the As imperative. each faster It time or therapy standard The XXXX, tumor to program predictive development drug is He design, a optimized Garo described, algorithms that to benefit. and tumors. patients biomarker making. to lines expand made customize progress will predict of broader uses VISION clinic signatures enables major and molecule It drug to It months But our during capability. system. better candidate selection. speed VISION human objective. years. real industry of advancing those for innovation generates intelligence artificial is and work from mimics in discoveries. It VISION microenvironment that The defining to Virtual discovery any a biology patient's enable XX VISION assets of immune drug which mentioned in explore VISION major to is system. discovery drug provides and faster why control patients’ recapitulates opening ways how we quicker the ideation time range great four in data their treatments feedback towards of that remains drug Immuno-Oncology. our defines to time quickly What

this More which June. to differentiated also differentiated includes Both antibodies provide his insight preclinically meeting. upcoming This in And includes have year’s virtual best-in-class includes annual featured course, on believe And rise of activity also is potential Officer our the showing, that is will we call of AGENXXXX, to O'Day, to Medical molecules. has pipeline Dr. inhibitor, our Balstilimab, said, clinic. Steven? our the helped activities I'll disclosed annual meeting our including and Steven we to we at CDXXX showing That's importantly, be the give over differentiated in clinically. This AACR VISION turn Chief activity anti-CTLA-X an this the ASCO with antibody, antibody. believe AGENXXXX. early our XXXX, PD-X in

Steven O'Day

Jen. you, Thank

antibody. Garo at clinical disclosure strongly The anticipate strength supports additional additional the clinical show slot preclinical Jen we've We clinical data evolving made and the upcoming data of bindings to and the conferences. As discussed, progress AGENXXXX AGENXXXX. engineering behind continues with this

or be cancers to alcohol tumors, microsatellite cold to or levels traditionally, data tumors have mutational This PD-LX tumors burdens. are in They PD-LX we lower contrast are of can expression. have of stable continue tobacco, These matures, tumors related expression. they pre-tumors. difficult typically typically I-O negative mutational burden. with that hot are or a exposures environmental tumor to hot higher higher see tumors warm in in treat low set therapy. very the is tumors warm microsatellite like and they viral cold and As responses have to typically These high tumor They

with has The inferior dominated have by to in to tumors due In tumor referral trials. to This agent refractory we addition, affinity traditional Phase with which single I-O was responses treated allele. to would CDXX low patients cold CTLA-X X I-O importantly with have date CDXX an a we response. response antibodies. allele, patient have patterns Recently, noted be the XXXX low to a trial suggests patient with data first rapid PD-X and been our first-generation objective hot I-O expected had affinity melanoma, clinical

adverse regimens. favorable events, I-O reported is treated or Regarding with and been no to mediated Yervoy hypophysitis, hepatitis pneumonitis encouraging patients have immune to-date, based which compared

cancer, inhibitor April, believe have clinical As we we've with annual and of cancer, seven MS monotherapy a regulatory continuing in in our melanoma. ongoing objective of including total patients. patient our trial, Balstilimab. our of and Phase Studies combination cancer, colorectal meeting path. development one cohort as actively in large We are in responses disclosure XXXX plan AGENXXXX that potential flexibility with in endometrial develop to We expansion two market at the opportunities. is in represent our latest X ovarian and in tremendous PD-X responses, stable in indications observed two two response current accruing responses in This AGENXXXX of exemplified responses with is strategy AACR the colorectal which

approval launch for targets through initial by accelerated the Our approval plan pathway. seeking rapid indications registration

the with our As including any Christine or unmet turn Klaskin call Balstilimab PD-X, discuss PD-X to over of monotherapy now financials. on or need. to to patients our XXXX I'd like top approved

Christine Klaskin

to XXXX. to with balance $XX non-cash to expenses first Thank months recognized and for $X.XX includes million million, used XX, $XX ended March per or XX, in or I ended period the quarter respectively, under revenue XXXX royalties of and XXXX for same $XX which $XXX $XX quarters XXXX a includes and XXXX. includes million expenses compared for quarter recognized of agreements. revenue a of related cash December the $XX compared XXXX $XX $X March XX, in for million. our XX, the at compared was Garo. million you, million loss March the XXXX million was as ended March Steven. million Cash share, of million We which collaboration net turn of non-cash ended loss $XX Net non-cash earned $XXX call $X.XX per our quarter three XXXX We to the million back now ended for which to XX, revenue the operations share,

Garo Armen

in again is is joining positioning so interest thank Agenus us The making year us this XXXX. for a morning. much, all progress and Thank your you you this Christine. for far very And for Agenus strong

balstilimab we this trials. registrational Phase the presentations the with with our to BLA and Eight, enrollment X patients. expanding study achieve data studies driving Looking to completing clinic, these X agents Five, to and commercial program our first pipeline and launch through strategy filed seven, own six, iNKT into intubated TIGIT our partner preparing of cervical advancing transition quarter and zalifrelimab. initiated sustainable value antibodies, includes Thank beyond, with cancer, development to and first manufacturing this progressing expect continuing facility and expect AGENXXXX work in programs, of approval, for COVID further four, for combination line items. second extensive on with with additional our accretive the Starting to clinical again, our into FDA preclinical and progressing commercial progressing list transactions. Two, balstilimab QS-XX, you, with Phase our BLA, XX, from cancer for plus of your for our an the generating recently for delivering detail supply our for three, our year, we AGENXXXX clinical data of attention. strategy having cash current iNKT for events XX, pipeline. And and nine, our corporate trials, of for product continuing a important with the

to we open Now Rebecca? will call questions. the

Operator

Securities. first our Riley And Instructions] is from [Operator you. from B. Mayank Thank question

Your line is open.

Mayank Mamtani

taking on Thanks congrats for questions team. progress. morning, Good our and the

Dr. to update checkpoint there on So anticipate treat, on, you a Garo’s the to allow just specifically, having of or could follow-up days. that, if to XXXX a what to year? provide sort ODAC of trial? said on Committee you're but melanoma, ask And inhibitors on color three do you terms then very may meeting what more transition Jen patients in continuing I And this patients was to could you you that to quickly over comment O'Day, extensively registration

the are broadly, checkpoint, of So I approaches what for the like as was portfolio? one your implications you curious different did just of were developing pioneers think you

Jennifer Buell

immune tumors hot on I those and ovarian, So stable we now to is responses disclosed publicly the in seen warm, microsatellite I melanoma. therapies, endometrial, are in considered being data or being have mentioned otherwise O'Day think those we also from AGENXXXX microsatellite Mayank, do, Dr. as what unresponsive colorectal, stable tumors what have based that will

extent of Now that publicly the been disclosed. what has we've

large the being And mentioned colorectal like well data we're as accelerated such cancer as our on cancer. for faster if O'Day approval, opportunities, so that have which very in areas in eligible colorectal decision – to as pursue driving market market been opportunities Dr. MSS

ask O'Day, just Dr. any has I'll other he So if feedback.

Steven O'Day

for the designed activity exciting to you thank we next-generation clinic. that's that – CTLA-X is question. I have Yes. a the mean, mean I what's us showing in

expanding particularly tumor and As disclosed publicly we don't. going that We're I've said, obviously colorectal types, in that's as well. traditionally

expand to large continue that not of markets strength to will follow will faster the will shying the depending cohorts, other markets, large we're pursue we're and our is areas we We the and because seeing where market expand signal, the from these goal cold and tumors science us traditionally on here, science. as we away signals are

Jennifer Buell

that seen we'll were Mayank, products the different negative available don't We our be our was – you've fast impact think expectations to meeting. portfolio, what track meeting. to product related consistent and patients. predominantly efficacy, any I with the opportunities. show And And to This focused to receive continue on made of ODAC course, tremendous from as

the And so pursuing, we're products those are obviously. that

think negative I us any outcome the in that So not impactful to way. was

Mayank Mamtani

any the data just any coming with synthetic Any couple ASCO, where and that, maybe on more. also and patients sustainable QS-XX the versus and supply the sort sort hot manufacturing many up a combination CDXXX on then you incremental cold if have color tumor, Thank you monotherapy, maybe of Thank process? at versus are how of color on you update you.

Steven O'Day

data the for from question. embargoed ASCO. have Obviously, Thanks we

from types with major are cold to-date are around toxicity it. trial is Phase trials we're trial tumors. any summarized. progressing Except say, typically you obviously, we're the more very all to seen and the come in of and ASCO details would come tumor as I the expect these this how we do into where that X looking forward give I-O can't And that pleased soon, be we – with so detail to monotherapy any anticipate, trials to approaches will signals very combinational have not So

Jennifer Buell

designed anti-CDXXX was I'll product a mechanisms CD words these agonist. AGENXXXX the for long-term the Maybe We toxic. differentiation a problem cancer. lot designed, that immune induce patients have molecules for liver on toxicity as Mayank, this any to really though, a molecule few been molecule We those know of design. durable has new The to responses they preceding with and liver with not just is a maybe to be – toxicity. it's been reminder are critical our bringing molecules for Predominantly, say observed. actually that

molecule the binds presence in the essentially, So ligand. the of only

activity effectively, If support call active. will we a its condition profile. or believe to that a of So little that more there's conditionally safer a we better tolerable profile

So I we're out will support come more that to on seeing as clinic mechanism. well think what in mechanism data the the as

Garo Armen

say, to fair the color green. It's is

Mayank Mamtani

QS-XX? And

Garo Armen

of QS-XX most, the Mayank, the is, if about you QS-XX ambiguity active perhaps most there's one a fact that no the as active, know, not so is highly adjuvant.

drive, vaccines components adjutant both immune That's element. response. means simply that what a that very, an the have of one that Now, QS-XX as very ThX important ThX mean, and does that

problem, haven't doses we're you of And now. year. with is been right The Shingles be don't in with that we going that of pandemic for if we're go continue, per year. are kind such confronted doses tens if requirement current as, to we're even confronted right we to this in the has been not it's contemplating vaccine going know to per that because had hasn't pandemics if of of know, away, millions because It we as typical now a now. billions don't in the new example, we the going reality, vaccine know been experiencing the pandemic the has past Now that for

to effective urgency to there'll state However, world's a QS-XX, what large estate our a that, it making try mind be ready the for old in has lines, to do very heightened of we like here the with to complacency from natural one compliance source accommodate of process. or That we're know that dramatically only with to rather highly And the a enough vaccine do And is state be started be dose. that produce ready changed pandemics. we of very to a to it material able requires need adjuvant, to we raw opinion, is about which plant the of talking source. replicate way quantities have to order in it, to cell from man-made of

small an a be it's science Mayank? of scaling earlier, said question because say, a of engineering, shown Does in process question scale-up now course, this in we've can of make it and And is what accomplished, effort. that the We’ve scale question, I've answer a right that's as in we different I'd that can And your now, of we're the not part. quantities kind right So scientifically of it into doing. one-third that of probably way process. we're done it up, the

Mayank Mamtani

Yes, taking for it questions. does. Thank you my

Operator

from Kelly our And is next question from Jefferies.

is line Your open.

Jason Bouvier

little for prioritize or example on PD-X Jason discuss do development for for the if a about how therapy of with morning. how the the antibody, wondering more, Kelly you We're monotherapy is can Shi. call. you This thinking our as setting. CTLA-X refractory you the combination second-gen in the PD-X taking such Bouvier Good Thank you're

Garo Armen

So statement, and let make will let I me then address it. and Jen a Steven general

in So our big perspective well as strategy that our make point have decisions on we important simple, factors on into we data disclosed have very from we that our very strategy data a is planning, And okay? based that our as science. based is because picture possession

as in tumors far. shown are pronounced at the markets represent activity in very large real said, Now immunotherapy tumors knowing very, that of end cold we're activity seeing around has Steven so one those spectrum, because and very

to is very on one hand that pursue expeditiously. strategy So our

speak, a On are at those other rapid, it. cancers are elaborate looking there don't there may so okay? a why very other specialty is for that to cancer, hand, where that the both be path on And Steven, strategies. approval of you we're So

Steven O'Day

development Yes. plan. I around the detail want understand people some really

doses know to the high path that flexibility expand there's some the or is we've it be to we're hot may tumor, that's thinking you we landscape. have see want as here rapid parallel reach strength options with where single and with you to lot will data. strengths to enough. It we agent we as comparative warm favorable the very can comfortable toxicity what combination more the if a and both the and cohorts go each obviously, most and whether know, we're profile. What competitive able to we of as we it's diseases, involve very think soon a carefully. it's about a And need single-arm the tell signals data to is been be be have I and the said of some we that we're as simply I do and as evolves to and is going of cold this a signal through studies, approval, trials What of in may as ready thinking

takes we're these ready see expand where and cohorts the us. data to so now And

Jason Bouvier

Great. Thank much you so

Operator

from Phipps And question Instructions] [Operator our Matt William Blair. next is from

Your line open. is

Unidentified Analyst

This morning. for [indiscernible] Matt. Good is on

wondering Or upcoming provide those what that you responses in before? you if on heard plan new color a the to from similar correctly XXXX I conferences. on, seen you've if indication? additional I and conversations. mentioned guys agency bal/zal, between to any Just FDA, and you having alignment focus conversations if the provide that occur And I I wondering on needs those color sort are there. you you the the of that ongoing responses those Then presenting could trial with could then of in just are know on the so, was are was if at if you believe, any the cancers

Steven O'Day

Yes.

previous I think statements our hold there.

clinical at meetings year. this cohorts and to actively expect We present and expanding data updated we are safety these

Garo Armen

those us for I inappropriate then speculate. are additional it and be And or on would to color regarding FDA confidential, the talk about think conversations,

Jennifer Buell

I enrolled, trial follow-up and data the very necessary large over the addition, follow-up you been say strong. trial I XXX and our the as the one look know bal/zal the we've was on that to previously that period, think would period concluded is continue has disclosed we've patients, median

So We'll this combination cancer. to you potential opportunity we continuing believe with a keep patients to cervical look updated. forward is real for

Unidentified Analyst

the quick, I quarter, now maybe the And think to to mentioned COVID had XXXX. of more that expected finishing you shifted you year. first one half dose the escalation I real trial, here great. general last sort just in up of in And wrap Okay, the think it's on

wondering on was could enrollment that I the provide are efforts So trial you the going if vaccination in the any ongoing that U.S.? color how especially is that given in

Jennifer Buell

secondary I'll of points of still we're So half here X those So see have we acute when right? to and COVID in to real from suffering who patients, well beyond Phase patients where as – to And bring opportunity have couple this independent we dose on expand syndrome ARDS, say respiratory a and of of complete in this, sequella, expand track course, opportunity to year. have escalation on benefit first those potential a distress we it's to COVID. just but the as a to real then,

a that continued be independent prevalence to in are the be we precede that high COVID. pulmonary quite number these will prevalent So untouched an of see cells of or development for of opportunities of disorders able

is Although, remains certain problem. communities, I a the still efforts, ravaging this despite is that the will real still we say seeing and pandemic vaccine are

Unidentified Analyst

you. thank Great,

Operator

We from Mayank. have another question

Your line is open.

Mayank Mamtani

also to cancer, to COVID you point, the just Like Thanks question, and implication your territories ravaging regard types, trials versus the these those are in also willing greater? you has study source and of additional making the how is I your that Jen, obviously cell be was the scalable. – very follow-up. choices, – ask just that doing in cancer are sort as the the of in of Jen, the also pain to where considering COVID what communities are terms for with

Jennifer Buell

with to and manufacturing problem. that we as So nearly doses publicly problem. based then we're of It's scalability, real prowess, a XX,XXX our able and The data respect have on iNKT beyond our scalability where it's these prepared isn't address, to gen current that. producing I'll at presented cells biology with far exponential go now scalability say, cells have test, the are an we And to engineering patients for a differentiation been this of actually Mayank, capability. seeing we're

needs So we It's a for now just we straightforward beyond in need and clinic what numbers. that as matter now, been have is AgenTus, to as cancer, And COVID. of in us. right it'll scale current the addressed and manufacturing scalability has the well don't address very far for our

far for beyond. and trial, the As plans of AgenTus’ on detail expansion we'll this iNKT more provide as the and the COVID

Garo Armen

be approach. And and our are be happen? by confront very challenges? point, to way the the that for the of just a should, Should vaccines forbid. address variants keep ahead viral able example, God to And to viable Should that this develop limitations the going future clearly, therapeutic iNKT’s ability to

So here. large will should costs do issue we manufacturing a on lot or treatment But to that of a foresee of happen, a large – not scale be on scale. if that were an

Mayank Mamtani

activities. thank – private, a to Okay, could updates these could is, of things might at yourself external maybe lot what from a there And ones provide stakeholders, versus you the how this looking of by you some be be you. going support public, on any follow-up

we color having? you you discussions, when standpoint, a expect any from timeline strategic could So of could might provide those be some

Garo Armen

pursued are prospects Mayank. of All these being actively

Mayank Mamtani

taking Thanks follow-up. Okay. for my

Operator

And we time. questions other have this at no

John Medina

everyone joining talk Great. to We'll Thank for us. you soon. you

Operator

participating. this today's you, for conference. Thank and gentlemen, ladies Thank you concludes

now may disconnect. You

Agenus (AGEN) 6 May 212021 Q1 Earnings call transcript