AGEN - Earnings call transcript Q2 2020

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Operator

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Agenus Second Quarter 2020 Conference Call and Webcast. At this time, all participants are in a listen-only mode. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Dr. Chief of and President Buell, Operating Agenus. Officer Jennifer Dr. please go ahead. Buell,

Jennifer Buell

with joining very be call website material much. you us. replay. available accompanying for Thanks our will Thank and for Today’s slide webcast is on our being

uncertainties opportunities. you to as we will we this filings release timelines and regarding clinical for include Before and risks plan partnership statements call development, including data that regulatory on to to These statement timeline, you we’d subject our like more our for start, and these statements remind are forward-looking as risks. refer and well SEC details

As today President recorded and being our on a to and for Buell, Officer Operating I’m delighted of business. Agenus Jennifer call reminder, Chief this we update audio an is are broadcast. provide

University Center; Columbia Chief benefits them guest, modulating today. renowned agents. Dr. and with Dr. University. Program the conditioning with in patients on Sarcoma tumor of at Wilky, investigator XXXX our dose sarcoma. and York-Presbyterian Research Phase DeSander, zalifrelimab Vice Author and and on zalifrelimab, she's in publication New have Joining Garo immune Officer; Head Drug sarcoma Business a in and Cancer the Wilky to and Immunotherapy first thrilled of Colorado an Dr. Dr. is clinical of aggressive NGS special antibody antibodies, us a curative anti-CTLA-X and experts Head the Chairman Senior to to Armen, Professor I'm expert Drake, is at of the Development; And Discovery; immune therapy, Executive of a Drake are Dr. internationally one in and microenvironment patients Bree Co-Director President with X trial, Julie Translational report Chuck Chand, Dhan Programs of me Dr. of foremost Director and Cancer clinical

call half over XXXX. to turn to the first highlight will of achievements key Now, in Garo I the our

Garo Armen

your for for thank morning. you us Thank this Jen interest all joining and in you, and Agenus

been Dr. our Wilky have development helpful busy review trials. to advanced Our lifesaving as from mentioned, thanks, near-clinical their as the special and guidance taking year, Jen latest well potentially to of This medicines. our for clinical for Dr. and interpret data paths pipeline the Both have Bree our of time rapid we Drake extensive from our experts, Chuck and their extremely clinical with as agents. practice

today. We generated you updates, some which share have of data we important will with

now up presentations five You end. year can in updates on and programs our also expect of conferences major to additional between upcoming at

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bali to our and expect call We our we commercial zali our products first anti-PD-X anti-CTLA-X, be antibodies.

to innovative pipeline in We component cocktails a of for balstilimab. own strategic early decision our consider innovation, an we our investing develop In on, with use agents. PD-X essential being as PD-X, addition in to made

PD-Xs several own are commercially there Although your others in to there development, and are available having advantages significant PD-X.

agent on extensive. list developing data with which Chuck. combinations. are and you'll Agenus CTLA-X, other later is They I/O for and first-generation PD-X multifunctional about synergistic I'm going AGENXXXX, that pipeline our is which late-stage this some our affordability pipeline, is. hear -- with from of the CTLA-X The you of to zali, include they first our flexibility our

Our next TIGIT antibody, next AGENXXXX filing Fc IND months. enhance TIGIT Fc months. monospecific the six six filed AGENXXXX IND bispecific antibody, enhanced our also Also expected be with in expected an to the within

Next, AGENXXXX, we not details a yet. the have of the disclosed bispecific very exciting in the And clinic, anybody AGENXXXX. on just composition bispecific which it

therapy you in the with IND, is molecule an And molecule our X-XBB a CDXXX iNKT bit. for in data Our about hear which cleared from which generic been will is clinic already. that and cell lastly, some cancer

PD-X of this our I list all absolutely with synergistic molecule. So, compounds that are talked about

house implied on our PD-X groups of these if a be critical huge will pricing dozen treating over combinations a with combinations, Another are in is a so an which advantage there control is effective novel far, way foregone by meetings is cancer, over control combinations effectively to treatment required that's based and price dealing having because that payer I/O be for and several the is to required cancer. conclusion,

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of me reflect other a now things. couple Let on

for the the development manufacturing. manufacturing and downstream and and in of to we move development is you bottleneck bigger immuno-oncology, number and products our Manufacturing, the systemic these substantial competitive rapidly a becoming Firstly, many yes, effectively know, capabilities include in as bottlenecks. a COVID-XX of Having to in-house, of These order own capabilities, bypass imposed capabilities. on us highly allows CMC due programs. and result of downstream capabilities lately a companies field have moving other quickly demands, as to need to in-house system, particularly

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molecules companies. in capabilities, Second, the superior with us of meaningful have We position with a those ago. in clear talk -- double large superior and indications to-date, penetrate of PD-X That in this potential earlier, mentioned numbers important, as PD-X also for are for to of which a are only in our with including, potential appropriate near-clinical own year. one our could also clinical having a little have It as combinations cancer patients those critically fashion, In combined PD-X with commercial for data infancy. discussed Based antibodies who of go offer combinations series slides five to of optimization on significant a there such this proposition own and these for a available you appropriate exceedingly importantly has way, market to have benefit screen, very provide value a important to is be six the the years. new order will next the our one when we combination. offer I as with billion about By opportunity bit to approved which is ours, the very visual commercially I PD-X our pipeline, the is the we can for which combined value there exceeds our success, Hence Today, today patient comments. as you I that a and benefit. needs overall PD-X is several significant in PD-X own $XX projections, see CTLA-X market bali. have expected their believe in already become in revenue PD-X billion target revenues a annual is for with several generated on $XX commercial cancer available CTLA-X that revenues

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failed As with you second-line target know cancer and have who first is cervical our first relapsed/refractory treatments. patients

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growing generation as as all. which we us there extrapolate patients to see provide for with are a opportunity at treatment and rapid well next in have with in today to angiosarcoma, importantly, may Also generation These a In a this durable PD-X of no for represent that and have on achieved whom six far our body there's patients all. evidence that failures addition, for a the really first means in months build clinical stabilization beyond patients that antibody CTLA-X no additional anti-CTLA-X no our we for continue disease at registration zalifrelimab, approved XX tumor partial so responses however, options complete AGENXXXX zalifrelimab rate data multifunctional treatment benefit alone CTLA-X in with antibody can XX% rare we who therapies.

study who has We Wilky, have led with being for sarcoma balstilimab with clinical report the world-renowned to today, first early discuss zalifrelimab and to trial the of angiosarcoma. over data. was to X with initiative our invited turn Dr. a expert, Bree of to University curative the zalifrelimab you potential I'll you. in who with an it you. and is treat patients or physician patient Phase Thank Bree without with our Colorado us Bree, absolutely observation at Thank an

Bree Wilky

much, you Thank and has speak of partnership for to all out our work amazing to these the to and and wonderful with inviting so opportunity Agenus. it's that today Jen, you molecules speak have about of come Garo with the me

the Associate the at Director And Sarcoma Director of Wilky. program for Colorado University Clinical and so I'm Deputy here. Research Bree the the am of I

in five those tissues. who soft and rare you quite know, that group to of a in And are They different what over more no is be setting. disease. sarcomas devastating surviving treatment metastatic are years they're with may have metastatic of less the to common cancers patients than than collectively curative they not with of refractory XXX therapies. So, overall all essentially bone for There tend of XX%

sarcomas And sarcomas. the of is we've these activity the next to begun so immunotherapy really in just explore I/O for frontier and

observe and I my during years in patients early disease the responses group. Phase focus so as these sarcomas. actually able to amazing immuno-oncology this And of to X we zalifrelimab as for how absolutely responses it with and to was antibodies some change influential was unbelievable this so the was trial I and first all completely time, And well create Miami, can me with part CTLA-X, my that on career made use PD-X

University the completely to now And so where focused laboratory led have that sarcoma we me a of on environment micro and Colorado both immuno-oncology.

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So, are often deposits these is that disease the well extremely tumors There the angio away problem lesion. with from infiltrative. primary are

and provide this so patients an disease. rate to but XX% probably Unfortunately, benefit, fairly these chemotherapies can attempt and disfiguring some are patients extremely they regularly. for undergo the wind and larger these And is tumors highly in definitely morbid relapse succumbing ultimately to are the disease huge, XX% remove curative temporarily up high, surgeries -- not to

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really of X.X that within level so to was years very tumor because of kg is but in ultimately, her thrilled And zalifrelimab infiltration, at to by XX today, we and on And it is and just zalifrelimab. woman obvious first went essentially say she her to unbelievable her the not angiosarcoma enrolled and mg see XX complete on immune have what achieved four days, biopsy. we cured response, this disease absolutely now saw per of the improvement to I'm that dose her later, exploded, a pathologically radiographically,

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had so in paper, we five XX of tumors of actually clinical radiographic with this weeks, or either patients I/O. seven And that showed at partial responses their those

responder those some able with in our to We were also delve to mechanisms super and the of you. make partnership available happy of biologic Agenus, data we're into to

encourage And because that we these this surgeries of as ability amazing these my angiosarcoma so folks clinical early to where has upfront aggressive because on response, on the opposed radiation practice changed and to this better this get of patients gone trials, for amazing outcome. patients tumors I've to give immunotherapy actually downstage and potentially a

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an so this the angiosarcoma-specific this. This And potentially opportunity available practice the treatment I'm about clinical that accelerated for approval lead desperate incredibly potential towards change really the an done patients. trial for could is immunotherapy, really be will options excited and for these and clinical and first for

only fraction that that be fraction learned a there. are a from angiosarcoma the it's the but So sarcomas So many diseases that these other about or what these we heading cancers, of to benefit told future? and incredibly of you of really in like CTLA-X We've patients where PD-X out I rest sensitive, appears monotherapy.

that checkpoint is a response is generate specific resistance initial have that tumor the sarcomas What mechanisms activated work the agents to components perpetuated doing that laboratory are we're robust why you this? inhibitors. the cells immuno-oncology T have one that immune So The with and then can respond to be in of to encountering? to that I'm suggests critical for

a of been immune in effects is early interferon of of that those on standard-of-care factors nature literature chemotherapy, many the responses to been danger has sarcoma years, palette XX for is to inducing described recognition. as immunogenicity you know, world stimulate in potent well and the with initial tumor X only still the so type but best ways helping is and antigen stimulate have by which that initial responses to And one the doxorubicin, release that

And durability excited response along I in combine our potentially and think to really chemotherapy is this the inhibitors I'm rates expand sarcoma, so with response. checkpoint that to of and

have trial sarcomas doxorubicin now that's second-line Agenus launched in we that with soft first metastatic of the tissue zali combining is plus therapy. and clinical so, also for initiated an And or investigator bali ongoing

see initial so on basically And doxorubicin I think on danger first then combination therapy. the PD-X boost we of full that of begin prime can take to inhibition. advantage And continue with you then And factors. CTLA-X the can and we schema, maintenance patients sarcoma

I'm first seen official I've And valuable to on I so any extremely results today, And that data, simply five cannot the it say patients this report leave from I'll while study. optimistic many the standard-of-care, could study. the initial investigation potential types is change to we about completely potential of doxo the Since tissue this treat this soft have sarcomas. really of how

that big a with it's I to Agenus’s will been while never higher bigger aim think so me. say afraid dream, And and

forward. incredibly future I'm excited so moving And the about

these all all patients So Thank and cancer. with rare work your helping for you. for for thank passion our you cancers, for

Garo Armen

Thank is Bree. work remarkable. congratulate your for on much We your you you quite very which patients,

world way the we it and with commercial as to company few ago, from be capacity we across national importantly different while us growing the for China. of all advancing is are while partner weeks to have us I based complementary we and not make significant therapies. China a innovative needs partnership I a molecules, rapidly products a Pharmaceuticals, in in of to able track have globally. different is expand of of strong tumors, today across highlight strategic but do to the of expand that address also the China, efforts right well. a lead They PD-X and to our Julie? we patient CTLA-X pharmaceutical which by enable growing oncology record partners the market, Now, over very combinations the partnership. geographies to call to building an turn will Betta high-tech DeSander, business critical for the A has Betta head Julie advancing in also And development level, all zalifrelimab. perspective, value the over balstilimab will global a be this to of announced sure value our now a of development portfolio benefit

Julie DeSander

Thank you, Garo.

over the the to The announced expand in PD-X granting still Greater geography to we for new China tiered the alone of projected benefit Betta improve in and PD-X in of important million to balstilimab in As mentioned, years in China grow and XX low meaningfully Agenus. $XX addition partnership $XXX region. XXs. a billion zalifrelimab exchange is rights zalifrelimab with up China of efficacy a therapy. equity, CTLA-X royalties over few an the ago, and next this the patients market represents million to to milestones a and upfront We're Garo in to balstilimab weeks $XX and Pharmaceuticals, cash for

cancer be us a on regulatory clinical footprint ideal their success first lung local in balstilimab region. of knowledge We and as important has the China that zalifrelimab which commercial of broad It from who first to CTLA-X oncology the market, Together for and with we incidence their has and launching China, the strong balstilimab deep in cervical footprint processes look PD-one our U.S. combination the cancer. bringing partner partner based in enter the and been product China to PD-X, cancer, in clinical patients portfolio Betta selected or the in approved expect with zalifrelimab to We CTLA-X. in was to compared benefit may forward times the to benefit innovative cervical their combinations

And We unmet indications half efficacy related addition opportunities with such for all indications which will expansion the Betta cancer. deaths therapy. be cancer label high These also improves areas exploring account liver in or of of could the nearly include our indications gastric China. need, as PD-X in of with CTLA-X lung, of significantly

look combinations update over an both forward new with synergistic these programs. Jennifer progress Finally, pursuing of we provide call other and of to upcoming Agenus pipeline agents now program will novel and our catalysts. I the on to Betta’s turn to

Jennifer Buell

refractory you Dr. Wilky you presentation. to a that exciting Julie. the We're was be our thank much, PD-X very you very we Phase in an zalifrelimab patients, maturity Thank outstanding see and in with from the three so of And thrilled have early again, days, it's And trial data partnership to current X already to trial, very responses. our trials. of patients refractory

to Asians We forward with a stabilization, prevalence we're have a I continued more looking over living clinical that of great future it's And trial we're see in And excited like these angiosarcoma. XX% with rare what also we're XX in for the tumor, benefit and angiosarcoma. of about are thrilled prevalent rate tumor. in disease durable course, launching rare highlight can is with maturity We in to a specifically China. And really U.S. results. Those but such patients higher the much angiosarcoma that to look data. want a be of but relatively of patients also the

forward looking partnerships. within our for and we're what patients seeing own we can hands do our So to globally through

path our when set plan success. on becoming creation, in you up company. touched clinically on out commercial XXXX, value on value created. outlined to company, Garo assets. focus is validated Today, a commercial for to our a we Now we become set a And

of some heard You've the data.

year you data later these data upcoming more You've this will medical earlier year. this programs at see and on seen conferences

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Julie productive GSK. As preclinical that the is we are course Gilead, collaborations and collaboration of molecules XX but development, this in some you Betta, into have you'll with most Eight we slide have of seeing also year. UroGen, will clinic see Merck, mentioned, moving what with our recent on very those be Incyte,

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pathway. escape Now tumors have a sophisticated

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to ASCO. now a responder you cancer this who patient a an lesions, highlighted have reduction PD-LX which to unlikely their patient, demonstrated negative, presented their I'm by by reported endometrial These target to O'Day to responders complete microsatellite been a these tumors are data Today, responder XX% CTLA-X. to XX. non-target PET in lesions, responders, were previously, PD-LX and genetic endometrial data complete on first-generation complete their and both with scan stable and they These also We CDXX that at allele, has slide stable microsatellite have negative, this renders technology. in partial Dr. Steven response them both be these respond their thrilled polymorphisms are determined of cancer, report

trial, nine patients with And which who patients patients data continues, XX we've disease currently in We first-generation the beyond stabilization, and to-date, total out are other. first expanded CTLA-X accrual indication. the and disease overall study. We're cancer, beyond for responses, over benefit is have rate, CTLA-X. our one the our pending the durable XX% of being a partial this X as Phase XX one demonstrated patients have a clinical of on treated about and of complete ovarian scans, next-generation two XX with to for includes months early stabilization well also of really trial months AGENXXXX targeted activity We as excited and responses, in now

in the patients durable who CDXX shared these Dr. PD-X with as be by his in differentiation in the stratification data the Drake its reported invited agent activity X of CTLA-X of patients we've cancers. strategic thoughts in development. for of general, and selective as disease this and mentioned, Bree of well full of a on early AGENXXXX And and on angiosarcoma. We We Drake? responders advanced response opportunities As through Chuck is molecule single that have his agents of already two I-O, failed trial refractory our Phase stabilization, quite patients XX zalifrelimab with in interpretation share may in responders patients. with And enrichment development see of Dr. to potentially possibilities allele specifically the for landscape the AGENXXXX, Garo

Chuck Drake

when But day. complete anti-PD-X on immunotherapy Hi, response until XXXX to trial Phase around to is happy complete that I've patient about this trials X rare. and success and is can Jen. Phase a cancer you on world responses ever I Really first XXXX. incredibly you. much kind tell I'm response, to X a been working very remains since seeing the be with here. Thank complete the with fortunate kidney of was in was not patient treat what I that in in had

so unusual interesting And seeing actually. quite PET this and in setting quite really is a CR

Phase reported. trials far designed data know, hypothesis test designed profile related activity a not safety you As XXXX severe adverse to and with points test immune frankly. safety X They're very really reasonable to to the or unexpected no so are for events

patients the doesn't system the on there a that stabilization tumor, quite disease eliminate other this trial mentioned The Garo think but I from immune trial, that into thing highlighted sometimes were quite enters long-term this wasn't is, these it But and you said say disease. months. remember, stable patients it had Garo disease greater people usually for specifically. stable number when large if just than perfectly, disease, stable And with say they of six

months six that really and not clinical seen activity early for So in Phase is X reflect evidence XXXX. does of trials, usually

you rate can in trial thing presenting tell response other cancer, that has anti-PD-X to people of them because a it, complete complete is terms But tell won't of anti-CTLA-X of using actually. responses that that synergistic, can volume position when beyond kidney prove are in were anti-CTLA-X, adorable the this is been ranges you you've no I and I'm Anderson call the listened complete do Phase there kidney word but cancer math actually responses, data the And I to XX% synergistic The that responders. the combined usually in in the and complete these follow-ups X are was on with Nizer showing that MD And many years. Tener word, anti-PD-X and this indeed that but in between XX%. three

I and agree and papers to then thing with Adaptive are the a do that this Treg this there's radiation of What fights synergistic. kidney back other when have prostate by which as tumor, terms in Jen cancer that anti-PD-X -- is, is we happens And hormonal Treg's. cancer Resistance happens so in anti-CTLA-X and called with and something published this therapy. increasing interesting it totally showing And described indeed with phenomena out, pointed that others for is, up you We the vaccination. also that CRS,

modified what that also, And XXXX published DLE to which cell by do that strongly it's back the then illegals the Treg's Treg's in more you I the XXXX. the cancer an molecule. those is it's Wade. interested, paper CTLA-X Fc all like So RIII. deplete urge XXXX interesting idea gamma regulating different have it then really, mutation and actually. using us Fc And would both by this has to Fc you're patients molecule about the buy to Basically, really if tumor, a care in portion, to is, up read you an scientifically to reagent doesn't something enabled be at really if fights

is non-fucosylated market. --clinical the those we really this a we There's hasn't anti-CTLA-X the molecule mutation thing this forward. think this for application is molecule anti-CTLA-X, development, moving Activity actually the fair. the actually BMS one it's activity these on Tregs an idea and clinical better combinations. of also had differ agents would competition. far depleting slightly versions and And a There reagent is data. paper some on that that much CTLA-X or publicly is the DLE presented depleter data add the and molecule like unique should I has beyond that is other from, don't for I so yet, mean, So I the but be IO early to other data clinic perhaps support, that shown have of in in time.

Agenus chemotherapy opportunities. spoke I work we're start with hoping cancer radiation some those prostate back at combining moving Bree Jen, thanks led and this really think this that about it with to as to start of to friends and And the I'll monotherapy our some With forward. that, of opportunity. Agenus combining -- combining with agent trials over to some with turn for

Jennifer Buell

without Drake, expanding Dr. we're molecule you collaboration for much. potentially and so We thank and can on plans rights licensing And on looking got this Thank U.S., much. again consider AGENXXXX. to very the you. you Thank that to exciting certainly your commercialize count will ex-U.S. in plan forward you question. We've this.

approach cold could into that prioritized U.S., approval are This would past include the the is molecule the patients. -- market We'll our a of for combination accelerated important of the as eligible to as cancer indications PD-X but approvals responding be curative lung with a will course, for you've large to responses have cancer going of include fast refractory this criticality market few molecules not the first like the also the do tumors cancer. design to this single we're form cell to could and a are terms basis durable the endometrial and as approval combinations indications through are monotherapy for portfolio combination breath could stable and the with prostate to diseases that to cancer that own study colorectal mentioned, we microsatellite well with In pursue of and be This tumors. melanoma. different of and limited These include, in arm a programs, further a market the like PD-X as so. non-small here Chuck prioritize and molecule large seen study relatively get within well development for as

offer durability. Our enhanced Bali expectation significantly with is AGENXXXX will combination

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Dhan Chand

Jen. Thank you,

substantial benefits. been commercial not of to a and portion a PD-X and have PD-X Therefore, spectacular sustainable monotherapy. do there therapies only success, antibodies PDL-X for long-term patients is small patients relapse had have respond need a who for While

may advancing deliver CTLA-X in We also also We're have antibodies. selected presented data new next our some generation patient first on responding populations. that on patients benefit to therapeutics important

The TIGIT be a up to expressing shaping first is with powerful combination decision especially know, in TIGIT. partner as PD-X all tumors antibodies, you

approaches different TIGIT technology We have innovation in designed to target ultimately Fc through two corporate our engineering. those

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Our an the combination ideal for potential mechanism provide addressing TIGIT and partner with current is deeper responses. therapy non-resistance to checkpoint to

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be AGENXXXX important Our therapy PD-X tumors. can preclinical relapsed/refractory an data demonstrates in

and of curative immunotherapy uniquely Our designed enable therapeutic pipeline combinations. broaden is to the reach

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the As you're cancers. has of in therapy liquid cell been active only efficacy primarily aware,

further iNKT it beyond and unique benefit position Here, our field demonstrate the that when our with to portfolio validates broaden These suitability competitors. can portfolio our and in combination exciting therapy the we curative therapeutic therapy. power of the combination checkpoint findings show in our comes significantly pursuing

Jennifer to update we early turn now to Jennifer AGENXXXX already under iNKT the signs combination already will an programs. the clinical seeing As of over progress with highlighted, trials commence benefits. on our of I call provide

Jennifer Buell

at already the term. similar the York, These cells within are the New iNKT IND clearance. the institution frequency the now very Presbyterian lung important start attributes prevented driven and near innate are We've injury, the a trial moderate announce features models reduce initiation viral will the iNKT of Very cells cells, trial severe you both of cells that inflammation both patients adaptive COVID-XX. be to and to we T-cells to with using we the very and to natural the attempt in with Hospital. next working the This Dhan. to data viral hope immunity invariant clinical Thank unique system, a to arms much overcome demonstrated combines expect to of or of iNKT show NK increasing our shedding, COVID-XX. cells treat cleared trial killer infection launch the and soon, allogeneic animal particularly immune the SARS-CoV-X and cells T type are conducted all

potential have just cancer, trials. with planned working trials COVID-XX, with great the agenesis Beyond cancer availability patients the readiness during resource to those in trials and and Again, And hospital launch advancing later now for pandemic. cells the for FDA clinical on are mitigating cleared clinical these we're also year. this

trial of that will So very start year. this certainly half quickly, the in we second expect

you reported not and benefit potential going capacity flexibility where have by tumor now. of you required and CDXD supporting combination Agenus, checkpoint checkpoint turn alpha cells. costs also ligand a are summarize data iNKTs cost a to therapies from well highlighted designed PD-X now combination over kill advantage. some solid necessary, supports significant without triggering to vaccines that move to plans they antibodies. of Dan to available has and of can eliminate penetrate these target mature infectious significant through cell action manipulation is cell therapy combination to with served as them recently therapy trials tissues, therapies the as We modulating scientists really enormous really can novel and curative a refractory potential us target That checkpoint critical a portfolio for beyond Garo is important our catalysts. gives with modification. clinic. call cell can into iNKT tumors, with antigen patients hematologic Galacto lipid curative liquid a term clinical with and this to go specifically Dhan to most of tumors The I'm known continue unmodified take augmented and And be Importantly, back I'll cancer near therapies. the constraints a just specific tumors issues this which advantage Agenus that share iNKT Agenus these modify iNKT giving excited forward develop cancer activated and antibodies disease Ceramide. cells the at to in typical by models as cell that beyond cell very form don't iNKT cell requiring on genetic active presented tumors, can in genetic important. the our showed antibodies, solid to We to activity

Garo Armen

an speakers, the intimidated enormity job of the immune at don't of of all is if everyone, outlining gets And did but this immune it that you, and to It of a enormous be by little to have capabilities properly. hold army I we have, confusing. system. what be this able And to Thank know capabilities disease a ongoing. military phenomenal we enormous the what that complexity military fat battle And cancer capabilities, lot. requires requires think will, times, you a enormity the such you It's I properly. the of it

very an by For Lorne it you of little book written we that we those here. who in a digging interested into inventory are bit more, have excellent, well Samporia

of the it. will beautifully. outlines a a copy immune be the works get to you. Particularly the that you Henson, of will Amber contact gift now. book you It first lecture back system way us If Getting from

design, the discussions and our setting. disease half critical get yet what so full you've on for road obligation of you exciting for earlier heard today this an items filing for will be which conclude our BLA second us beyond. trial for sets up to approval down cancer us initiate to year the an in our what is heard the of and balstilimab haven't confirmatory with FDA All Among far cervical and path

outcome For on combination and not balstilimab balstilimab for based a FDA discussions, the alone patients with prepared the and one, but for balstilimab cervical be refractory the will of cancer. plus zalifrelimab, I zalifrelimab filing just know in of that we

in mentioned we data alone. spoke addition will these balstilimab conferences, this present AGENXXXX present as with In further we data conferences multipurpose zalifrelimab, year CTLA-X will combination scientific also all molecules. next-generation Jen updated plans, are and on at to I about, earlier exciting upcoming medical Balstilimab on

And cervical. for not We the in beyond. and beyond expanded also to but bali advanced U.S. zali with indications development that's just trials geographically in plan

and also of and will Tregs Tregs AGEN-XXXX is portfolio. if antibody and AGEXXXX talked others where depletion our anti-body is the it's because Tregs systemically a trails have of the this the bi-specific Drake associated combination balstilimab you you depleted, intratumoral counter with initiate Treg issue particular We about in importance may depleter depleter Treg in that bi-specific which to be, with autoimmune intratumoral and to want molecule it

for We as development of will sustainable QS-XX. advance Jen our proprietary mentioned, supply process a

separately Finally, iNKT for with we will patient and trials clinical allergenic launch in cells cancer. of COVID-XX

and Taken the beyond, as to remarks. together, company the of now. our second our Agenus we're your trajectory year work, to companies And excited in your company, growth of of industry. concludes our and the for over hard patients progressive should one Jason most half in all formal I'll innovative, it position our turn of That this

I incoming questions. for process think a we have

Operator

you. Thank

session. Mayank FBR. [Operator We The from will now Instructions] from first begin comes the B question-and-answer Mamtani Riley question

Mayank Mamtani

seems Thanks morning. like for progress modalities Congrats portfolio. across have your several question. my the you Good taking team in on

data to could is nine types? the maybe Jen, have? going color see you ESMO presented on into quickly way in tumor be What, you to some convert what October? do the scan talk XXXX response these this about at on PR. qualitative And just Just pending partial

Jennifer Buell

much very Mayank. Hi Thanks for the question.

now every scan, So independent scanned patients six are weeks. are we these patients look regarding

the and now so Anna Wijatyk is that as the they well, the And here to allow waterfall we may our in you're with seen X.X at XX their watch that response requirements scan response. either that, sense continuous that with And to see seeing actually negative therefore, over at which durable will durable a They're They're us a time, we looking this radiologic watch response or as direction a cancer, what as happening trigger or that we're a not we period of tumors point never as tumor shrinking another. over this -- there for of or is of a complete dynamics growing what's consideration what what present that is patient and clinical when time that you're Dr. with team meet -- series tumor or we shrinking. is a effectively could plots such ovarian, what patient these seeing dynamics partial tumors. get the moving with your of one recessed months -- over And finding. have us be a for requirements for ovarian

scans these watching we're So tumor patients and to respect they of their see these dynamics to conversion responses. with to where are

certainly and as plan CITC upcoming also you'd we as program, of are most cancer conferences XXXX, as one a are there mentioned. few upcoming on a to well There's present medical couple medical other there our and So cervical as data conferences an conferences. on do

of the have can't in yet abstracts Now, disclose conferences we process is, here. course that are review

programs, inform So yes, can But will you where we including and clinical be presented. data our as as can, we expect will XXXX. updates you as we that soon lead soon on

Mayank Mamtani

taking Great, on, versus the it you How thanks. broader good clarification. you then thinking back? tumor you just stratification lot Thanks demonstrating a to are about that for Like comment now XXXX. how a do So step Garo's by matter given about Is are activity? And it it allele and on is know, is a clinical -- strategically going it? a with, about two and very think both especially zali types?

Jennifer Buell

Thanks very much, Mayank. Very here. important question

We AGENXXXX. are reiterate seeing just now the in to responses. for And

have We a response. complete

So complete we've response. pet reported on a and now

So observed. patients the here, disease stabilization those that term long as of two stable we've have responses durable as well

a seeing demonstrated patients us to that mutation does allele from this responses, a have to the particular as first is are as for biomarker have us and those consideration respond as genetic therapy. or unable This the we on others allow in data generation unlikely patients are that CD-XX to well what presented leverage stratification. Now those those

zali and tumors Now there we data filing. for have course bali, in are hundreds BLA And, of worth assets and generated with mature there patients of these preparation are molecules. of

things, molecules these We have the And the development to significant agents to CLTA-X opportunity indications these where or tumor know we expanding with with PD-X. in support in data that for to agents a and as that already IO will guidelines market access these approaches activity these there into expanded their that will NCCN opportunities of data approvals. of larger a patients, course, us inclusion few allow our and further allows generate zali well physicians then, prescribe to continue that bali, tumors for as expand validated these is

very laid we have don't quick of already for work. Now, indications, bali, that because zali a lose indications the are path we where these us, advantage out to so want know they take opportunity will to in

refractory respect we for we identification this PD-X in activity, patients to which have with that allows with molecule have could particularly in the AGENXXXX, response. some pronounced for cases enhancement, Now believe of polymorphism

of generation hanging allele the identify low us, our And CD-XX that are it's in as trials. lifecycle next them have response to and therapy and overall is course, likely well as looking of differentiate most to. a team's therapies. And opportunistic, patients a generation and allows goal patient, for to of our at they management the us it patient to fruit to first critically our every are have Our respond is on course, likely include most

Mayank Mamtani

And including, you in I the think and if And partnered part which I on GSK I it's could some adjuvant squeeze final the your can QS-XX has that it. comments question if also has Gilead. helpful. comment about know, a programs, in collaboration you AH-XX been which the with think the talking then two around, XXXX, has saponin Very question just around around QS-XX,

on of what putting the specificity with as kind going your terms work of out you have in the us you -- with remind and terms Just partners, is this some data? that more progress

Garo Armen

next makes in seeing going our portfolio data, on thing. partners. as we Gilead generating That's forward seeing data think, we of data we're partnerships developments, said, crystallizes And that near-term existing ongoing molecule we're Sure, XXXX, may I our concerned, far and for are Mayank, as with as gen and you terms a valuable. an I example, that it that milestones our makes multi-purpose be as you mean, some our CTLA-X, the hearing reach will very others have

important our look and breakthroughs Fc also one you our XXXX that's if followed mean, then that we last on. design all specifically to of course, to fact, molecules biology, engineering In so of components about things important of things. in immune cancer, I very and TIGIT, be at is chance, come by with believe, I/O, a not ones going had the years, molecules, in the been system. most AGENXXXX believe knowledge developments knowledge designed the these All knowledge do we five on that field, share but of of have based make the certain our these

very that's exciting so And for us.

not have U.S. a concentrate we efforts will because Now do our reach in the we company, a global as commercialization

purposes. and fee of portfolio from to going our ex-U.S. you can a proportion rights for higher have forward, increasingly U.S. retained expect So us license

us. the with China, ex have the in everybody by So that's for but companies, going U.S. is led component. U.S. wants to market be our But also also the it's And growing, you know, cancer Mayank, path that generally other as forward to discussions geographies. clear,

will So much the hence, of that market ex more partners value generate become our U.S. will future of for it in significant. collaborator the terms

why people GSK I of as made example, terms one And doses the to In QS-XX. that that their of have if was, reason contain asked is of said, very QS-XX? does about And subject, was the I've mean, available, simple. not, is, billion this QS-XX, asked upwards question vaccines. not? So COVID so a me complex it question, another And for is not again, the does adjuvant systems for the it answer question contain

near to QS-XX enough a make or anywhere cannot You it. doses day billion survive

even make can't You QS-XX. XXX of doses million

So what that explore, do? we for does of a raw obligated, QS-XX high to that responsibility we're that make That are making saponin. sources renewable sure means sense materials with

people. realize vaccinated treated There people -- or been it's over sorry, other that that I source no QS-XX important has QS-XX XX that that, from So know, in saponin it. is many you I'm million has well any very with

proprietary manufacturing saponin to Now, of us no why terms example, are known has else and proprietary process. for has in no rights and to one that GSK known to saponin one that's manufacturing, how which QS-XX else,

be that are QS-XX. upscaling on a material Jen making engineering actively with It along from the process, for we're we Now line working renewable talked expense that raw proprietary feedstock an working is about. will what cell that manufacturing perspective, That's on. like

the that Now, process. of scientific through validation we've gone

saponin is that QS-XX the that process as part. that the So example, we traditional to for tree make natural and from saponin we from the profile exactly know we've same made QS-XX

So is that's scale you tomorrow? people cells And simply plants been take Engineering done. time of of say that why up ahead not us. grow. is behind is It's so us. simple step And The can't next engineering, well, to course, scaling up. science because

takes from sense we up little well. we scale a of as do upscale will responsibility, bit with us, will bear we and up. our so of scale effort And But this, will

four something reverse COVID-XX And five Now we vaccines leads five, out have importantly, advertised. vaccines know the of been of their that in some have formulation. should adjuvant that an like there those show don't

its those hope perform, efficacy the if that will we or a Shingrix, happens, activity, perform exactly have for one, boost example, you don't similar four even So, and XX% as in if fifth to needs they in plus all vaccine. one

plus between the two? contains have XX% are the For efficacy efficacy, the saponin, key Shingles, Is the what XX% other doesn't. one differences you QS-XX

So, COVID purpose pandemic, ready. perform that in will, the we or do. should that will for for we Mayank? to vaccines future like then help as we this what they answer be those need pandemics, sure we make all question, your would future of Does That's hoped because the don't they

Mayank Mamtani

this definitely, learned what are performing week, earlier And Yes. adjuvant relatively vaccines better.

you from and forward Appreciate to, the color. appreciate looking absolutely taking on question. broader So, updates so you you Thank then my more much. that

Garo Armen

Thank you.

Operator

William [Operator from Blair. Matt is Phipps from Instructions] Please ahead. question go Next

Unidentified Analyst

on Thanks question. Matt. for is [ph] a Hunter This Hi. for taking my

I wondered XXXX. first, on Just

sort other toxicity the tolerability event could of on some You I there provide and any mentioned was that is color no observed. wondering, adverse you there? liver if

Jennifer Buell

much quite question. for is very tolerable. your The really Thanks molecule

the adverse emerged this and profile. might events I well. on have just your a we deleterious could safety is as Wijatyk She Anna to other little have a So not, feedback events. that maybe color here really -- No beyond, adverse no from speak and

Anna Wijatyk

Yes.

mediators has the -- but No safety profile predictable moderate as ordinary. events, events mild what for far consistent mild. the unexpected So immune accounted and and been not pretty pretty with

Jennifer Buell

much. very Thank you

Unidentified Analyst

was but only five on tolerability the there. And also wondering what you. the looking theory? doxorubicin then study, I patients was there's wondering, I'm bali this I know zali was and thank with I like Anna,

Jennifer Buell

line. still know So, I the would the like clinic to see that she had line? are starting, is Bree, if I still on Dr. you Wilky requirements on a Bree

Bree Wilky

the question you though? Yes, repeat I'm still Could here.

Unidentified Analyst

Yes.

was tolerability doxorubicin Asking the zali tolerability on and what the like? looking -- bali study of

Bree Wilky

in it's will this that period any that a at DLTs we lead six the are the little today, again, But say actually prohibitive So early. safety our We're patients. is combination. limiting least with I haven't seen

Unidentified Analyst

Thank Perfect. much. you very

Bree Wilky

Sure.

Operator

closing are like more There concludes the questions conference no to any to in remarks. question-and-answer Armen, turn for Dr. This queue. our session. the Garo back over I'd

Garo Armen

And we'll for us Thank you and be on Jason, occasion. at you as so for look least to much, very further much forward this as everybody very are. Thank you we informed, joining We could keep for everyone updates. excited you. thank

Jennifer Buell

you. Thank

Operator

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

disconnect. now may You

Agenus (AGEN) 6 Aug 202020 Q2 Earnings call transcript