AGEN - Earnings call transcript Q1 2024

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Operator

Thank you for standing by, and welcome to Agenus' First Quarter 2024 Results Conference Call. [Operator Instructions] I would now like to turn the call over to Zack Armen, Head of Investor Relations. Please go ahead.

Zack Armen

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

Executive Garo and Chief Officer; Klaskin, Strategic Todd participating Chief Vice Dr. be Chairman Dr. Commercial Chief Agenus. Christine are in of Adviser, session. Taylor, today Steven O'Day, will me and Joining the Yancey, Chief Robin Officer; President Officer; Dr. Medical Dr. Armen, Q&A our and

over to Now to to I'd the call first like progress our Garo? the Garo in turn highlight quarter.

Garo Armen

are mission, I'm edge that that closer today's important financing share in the as morning, Three with our immune the you Good Ligand into lives Today, transform treatment. we relentlessly change our Thank for our with develop milestone leveraging goals morning, a phase everyone. to with commitment to $XXX million realize them, program BOT/BAL option for other we readiness planned a system very strengthens which reinforces cancer. this million realizing a colorectal we profound entered ago, partners Phase joining several our the agreement that of much financial founded Pharmaceuticals. the to this us patients. was dilutive add infusion are $XXX power development since, could on will of relapsed battling dramatically as commitment agreement and of cancer capital stands entirety this transaction in the and been in announced underway. Ligand's initiatives with us the Ever keep key to making initial call. we which and our BOT/BAL to minimally next of this, Agenus agreement currently landscape CRC, from those into syndicated including million our thrilled us pivotal allows to journey. This It's cancer significant of $XX in the is its to MSS confirmatory to parties, we also to program. negotiations, that position groundbreaking will more already commitment propel to decades This can bring royalty have more. our total bringing million add programs, up a we $XX commercialization pursuing leading for BOT/BAL as study to importantly, BOT/BAL for addition This And activities, open $XXX in our III million. refractory, options an support in in

end $XX the Our million. was as of cash first the quarter of balance

across over our from With cash so and burn progress positioned our BOT/BAL phase work transaction, do the cash efforts enter cash patients bring additional last for with successfully to our quarters, our as mission-critical are sheet capital have strengthen we further need. infusion mechanisms of additional the rate programs. Also even received discussions will strengthened to balance this also we to position. critical of importantly, We're the very we in in few a BOT/BAL to ensure reduced our our continue

prepared included planning challenges are regulatory potential outcomes various scenario financial lines, partnership we ensuring for detailed Our well and opportunities ahead. time and the

we continued the Russell And our of in listing more a minimum regaining based which assets. the price Russell we Indices. are last stock three, XX, to X certain to enabling a And criteria a share, requirements. during of institutional regain inclusion achieve with compliance investments One, satisfy on April confident of reverse as week. cap confirmed requirements the require close listing $X to Two, QX NASDAQ the the objectives. our implemented by market We've above on the with Our price. key that is for split share eligibility compliance investors days, Russell NASDAQ in maintain was trading stock to

valuable our initiatives queue. in are funded our Chief investigator-sponsored both cancer. O'Day, investigator-sponsored. our vital earlier our the have investment will progress who had stage patients. I our trials to might on in Dr. provide Medical to to Officer, our expected as and also requests potential options the add I in our on is focus expand latest of shareholders an Steven that capital, number Steven accelerated our will on an an disease bring floor now of our particularly colorectal focus to in lines optimizing This therapy strategic in BOT/BAL focus update ability through benefiting pathway and we is to and of treatment advanced and lower part externally global Our medicines we base for cost progress. will unprecedented broaden turn filing of developments this

both sharing results to confidence the from and various and those your on you our future. our look studies address needs continue ISTs Agenus. in to progress future again Agenus-sponsored potential about BOT/BAL's to and We're more commitment significant The solid excited to forward the support cancers. Thank for in reinforce across updates near tumor continued Steven? unmet

Steven O’Day

high colorectal our on an not not cancer, and Thank tumors. therapies. Currently, the have a our refractory patients demonstrated balstilimab refractory with durable from large this DMMR is poorly is immunogenic liver lead majority benefited of established These you, tumors indication, of relapsed deep Botensilimab wide or in program previously BOT/BAL variety solid which across metastases. Garo. I-O without of or active adults And group MSI I-O responses has cancer. represent combination and with focused the poorly of is immunogenic success

We make substantial progress. continue to

As colitis, all expanded and which diarrhea with indication, or most metastases. regimen months, and median this follow-up. enrollment or The indication. in botensilimab overall this a is cohort estimate Phase randomized contribution cancer estimate in active were seen in survival trial to and the patients. in of II contrast the greater release months of to XX XX% of In set colorectal rates managed not median press data, response patients were with of provided overall global and XX% whose mature, care without approximately of an patients Grade which in XX in to common XX% stark with XX.X now continue combination in almost DMMR BOT/BAL of occurred therapies. rate XX for our is are we therapies overall this and there of a treated of designed Ib of treated a overall These April we've balstilimab, response XX, mature. X XX-month is MSI accordance confirmed our observations this survival overall data Phase median survival XX-month safety overall XX%. The months or with immune-related standard in colitis of a large to survival X% diarrhea with completed standard tumors in XXX metastatic of evaluate liver trial dose was the November X% stare high patients, setting treatment treatment-related This less. In XXXX, and components from

included standard arm. a contemporaneous also care of it Importantly,

filing top mature a from of the to this trial demonstrates our I Phase from this from results cut the with to to March Phase confirmatory with in data upcoming expanded on in by the along II We Results plan Phase alignment look trial data support anticipated from a evidence the a gain submitting of We at forward the III an July trial with cohort of the XXXX. half set, second design trial, Phase from results filing scientific consistency in FDA meeting the real-world XXXX. data this Data BLA and more stage a follow-up. our anticipated of year. similar meeting and I end the

in approval. to So and year support an III trial accelerated enroll Phase the time will commence this

complete with data In include the which rapidly therapy obligations, structure Cornell, NEST our the major enroll. pathologic discuss including had of and and high trials setting, NEST dose an a is patients upcoming out or these due which from or near BOT we with has X delay regimen, surge responses patients important our X medical also colorectal lines will at earlier X investigator-sponsored be in ongoing, of to. neoadjuvant patients XX to stable and original of the will These Dr. This and at treatment We Tasi in complete in of Phase MSI continuing and cadence Longer complete for referred presented X submission. responses showed None Garo cancer, of the MS III NEST pathologic have responses and colorectal as BAL. to treated expand include meeting. patients. trial follow-up X trial out

standard early actively Malon important line patients. been the tolerated is I metastatic or second colorectal at Fakim FOLFOX He first-line and with metastatic FOLFOX care bevacizumab want to is The metastatic plus Dr. Hope. the of enroll to well highlight and has patients. regimen with continues date, combined rechallenged To trial XB BAL of regimen investigating BOT in City FOLFOX

early-line in malignancies. across as serve upper could XB different colorectal FOLFOX example, an forward, settings malignancies, several regimen cancer including active GI for Going metastatic

younger earlier in to Our stage disease in colorectal cancer, and and goal outcomes a is impacting growing patients. improve late-stage both prevalence

Phase continue to several or follow trials BOT/BAL in BOT we important Additionally, areas. Agenus-sponsored maturing with II

The is a alone second-line updates hope of a We half PANCREAZE metastatic study the with to the II combination. gemabraxane BOT/BAL or BOT melanoma to trial comparing refractory refractory first on alone. second XXXX. BOT Phase second in is And provide these gemabranze data

will the turn call commercial provide into strategy Robin? over more and operations. Robin Taylor, to I'll who insight Now our

Robin Taylor

supply CMC BOT BOT planned Steven. Emeryville our on you, and and facility. team focused all subsequently third-party GMP-grade are owned of preparing operated BLA CMO of for launch with and BAL well Agenus our both Thank prepared our partners wholly at is our In at submission, based to and us parallel the commercial through BAL.

expansions have commercial the operations. leadership successfully team experienced XX colorectal respect tumors. access participated commercial solid market I With of sales have across preparations, and label cancer passionate therapeutics led members and other hired marketing, novel Together, and in or launches over highly and commercial to leadership the a or team in of

XXX significant experts oncology. we've partnering GI across the clinical both urgency our option BOT to settings. From there academic medical community this are GI our which affairs treatment with GI and BAL, it closely to gather research global and for the the oncologists, market that clear market research underscores discussions is world's anticipation teams feel important oncologists in deliver and conducted We and insights with U.S.-based over with patients. from is we to And direct

turn Now I'll discuss financials. call to to the over Christine

Christine Klaskin

Thank you, Robin.

agreement an as to Garo strengthening our Also, and morning, of cash with position. a equivalent a of $XX ended thus with additional $XX.X million first we at XXXX mentioned, initial an of our Garo million quarter Pharmaceuticals, compares option cash mentioned, to As million. this investment $XX year-end. This of consisting $XX.X with Ligand million announced $XXX an we million, cash invest balance

operations XXXX. to used $XX this for million first $XX December quarter the ended during fourth cash was in quarter million Our XX, compared

to compares quarter loss includes of in incurred This and million, XXXX. noncash million first million which March of a period of $XX noncash of $XX.X loss net for expenses the revenue we net which a includes same recognized million, $XX.X ended $XX For $XX expenses XX, XXXX, of million. the

compares quarter net Our loss Garo. which share for quarter first share now turn first the is per to the per for back to $X.XX of call this XXXX. I'll $X.XX,

Garo Armen

Thank you Christine. very much, Robin Steven, and

we I developments of conclude coming want we recap today's anticipate As pivotal in to the the earnings call, months Agenus.

on our activities, critical research significant of will to track million infusion and efforts. which are cash efforts position strengthen a our and midyear, development up registration to support We by our cash our secure commercialization $XXX and

with in application. key initiating biologics before will license meeting our their we the milestone Another concordance important FDA have be and our

by half expect and further at of present for data will year. rationale this strengthen sarcoma cancer, major this these We're meaningful and indication very all where investigator-sponsored trials, unfolds. you are developments We to Agenus. on cancer for a along Steven will shareholders to as outcomes These year [indiscernible] once critical look there our we progress lives very effective of Additionally, chemo-free, pancreatic continued who trust is therapies. highlight make have in represent through again in need underscore data with data in we cancer with and happening innovation exciting And for data potentially for these altering more Phase to promising patients, melanoma, about patients' to the these our in left. Thank our presentations a impact conferences. Furthermore, in the the expected our strong to be in support we therapies. and which much a sharing II dedication These or second said, additional our from no the lung of limited trials. colorectal treatment release, forward endeavors II durable believe also cancers options Phase oncology encouraged your as potential I our

Now believe you for I questions ready may we're any have.

Operator

[Operator first line Your comes Instructions] of Bodnar Wainright. question the HC of from Emily

Emily Bodnar

the on progress. Congrats

confidence, Phase thinking patients you II studies your without? CRC at support if question, data patients many the enough with how efficacy guess, and confirm that the across you approval? have recommended for may kind also for kind II Ib CRC? cancer? dose second if and And And you BOT/BAL of about accelerated Or you've melanoma Phase on are to if could pancreatic II BOT/BAL are question, these can of discuss And feel First that I how near-term you you treated is for like you're specifically then just an MS Phase seek you're Phase strategy the focus indications if approval data regulatory commercial in positive?

Garo Armen

I Dr. thank top very questions, into O'Day get line I'll will your you depth. Emily, and some question. give answer Certainly, you for ask much your some then to

an tracking together including the see the the on package maturity it's our months, ever a of can upcoming First from in And make randomized of last including Phase the conviction have alluded you data today to, the that data take intensively from the pulling study of stronger the as X FDA. the will compelling involved data, been maturity all may with before compelling almost case. is as meeting the for X cohorts, II trials in based durability Steven we as data and we maybe to than how the we well all, as know, all

more with right and statement of cannot in on of be the the are we until a the in course, next and developments definitive ambition. forward now on we we meeting get state progress Of need their the this optimal make But to FDA weeks. we several are will and our concordance preparedness coming an where outcome

on collaboration we the terms lung are because numbers coming fields. important of we now, our Those that cohort the and in in in CRC potential focus this from absolutely actively about is are that other first alluding of cancer lead to we Now fixated of we on And of potential opinion leaders these but will each be pancreatic questions key months, in understand that course, I patients approval. considering our whether and can questions are, for melanoma, with right very approval.

less additional place that other that Steven, specific is we as focus and a to into you resources with well. Emily priority. to everything of So else some the of of a year, now those programs But financial expect But can if the between the questions come the asked? little more end put will address the

Steven O’Day

Garo. Thanks,

combination the trial, going not numbers, the get Phase specific I can into I So randomized have unmet the both doses and are the can supported with pathway and but II clinical think the a we number to patients what we're that absolute the X -- say in Phase given we an of II accelerated and active Phase Phase of this efficacy I to is the with significant we pharmacology safety, BOT/BAL trial need setting. on in and discuss with

Operator

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

Mayank Mamtani

earlier. noted updates the on Congrats

able you the that press to able are I I your if especially able the And of you're the a couple a FDA go from there? And emerging said similar in minimum a secondly, everything. your trying accomplish today, to follow-ups. would think team, has given a at noted you bit patients package what the have been X talking what scheduled. that submit prior meeting on you've Phase then you're in in comparable Phase data to and that it's is to stage clarify II if encouraging. a slightly to Phase we II alongside it's on you're detail release little comparable and follow-up And more -- parameters outset about So at are expectation Are enrolling cohort And stage. earlier to that before you you there's give mentioned

Garo Armen

Okay.

courtesy to not On will an is, and it That address just that data, the discuss would we a earlier we discuss have data call a and the data we not of ensure be we the subsequent repeatedly, FDA. details in please question, it preference cute course, present have the major. present Mayank, this our And to is understand we to will of to dose, very said will of data everybody here, the the opportunity which the that to trials, efficacy set the study first consider we that, selection a elements that that the and support the of trying to of important contribution we're our preference seen it. have and that not to be do

underway. So will no these you are get on until details further this steps

not FDA we meeting that of rest potentially request we a approval important In meeting the the will on And accelerated the months lines, But sometime terms ready half the the modules all the second data for expect is I assured the as be of milestones this X FDA based for of certain be of we the they on meeting are be we on speak. submitted soon potentially readiness is that in believe cylinders post say, next statements be that going following on And filing we depending all of outcome of it full could modules in as going gear this course, granted that And the in for as all we're a up meeting. meeting. in FDA circumstances, are we But company making as most that that getting meeting, or state is as the scheduled, we will July. public. make time meeting releasing it. about have now the may

Mayank Mamtani

color. appreciate that I

or X. Phase to Is II? from is you are think, follow-up from of much terms follow-up Or of sort that there Phase like months a subject XX I at, in practices the follow-up to you the need discussion? requirement the from Phase particular On best have how -- II, in the

Garo Armen

Okay.

this, follow. has So advisers what the on based is guidance on that minimum historical course, input significant our from on But the be. we on of regulatory that FDA should had have precedents minimum

the Of do XXXX. sort can enrollment wait But X course, ended of minimum on going to II you in the the October a the years, in we And from And point then module. but the that. the ideally, clinical that, be can of meeting. period the not with we're extrapolate Phase based and between now meeting, FDA beyond to BLA that follow-up filing potential what will FDA

Mayank Mamtani

of to what you term Makes in informing sense. number dose ISTs? able you're also of near in you're on of then you ISTs last X I And have if Phase after believe clinicaltrials.gov. even expect I what comment have setting, these IST implications to able in sort And BOT in the trial up the on level Are one that the on And then earlier come with look specifically, comment could data that on the of that about the set financial using CRC that. like? relative line data question III most

Garo Armen

Mayank, you, that question. thank So for

unprecedented been have of number We confronted with an ISTs.

is what do ICTs Clearly, IST a IST resources, people, requests. our we number and resources, because well all given requests. require the that mean Now financial satisfy I human not XX of financial resources, but just these of the resource cannot from don't number? over company, It's my

rationale selected on data these generating on of potential several are handful them. So us. of subsequent BOT/BAL data the to a different in supporting will indicators handful And trials. significant the course, we rationale clinical our also, have And of in that approval pursuing important agents zeroing of based ISTs generation for that be of of are

an that that some and our the get time in be the in cannot BLA be being and collaboration programs, process sensitive for not consideration. particularly to these in but that our provided be not are data during FDA the of cleaned generating IST are we or discussions, decisions to tabulated, with be expending regulatory key, caught we do of basis we'll so time rest our So up prudent in to make the reviewed will also assured potential of advisers ongoing on reviewed

a part are these process. considerations critical all our of So total

course, or are whether addition brings because on should see because the we've great CRC. think interest best or, efficacy lung, in that activities. activity we that, I it's that's not CRC. the ISTs significant number specific pancreatic, clinical careful a I'm that in we term -- another in to melanoma, They the to has had say, specific deal the a of I question not use efficacy of that of of the that Now saying to have to how sarcomas. FDA seen sarcoma a are tool That, shouldn't that I reason you There's we say happens the is terms of be

course, significant activity that the else as focus but CRC other of we I any we in interest ISTs is, have strategies. the failed we to in of because to not everything have patients But There right of treatments. the earlier, responding said to they're sarcoma very pursuing seen lot and just that not need now. approval also are that cognizant But on very, a

Mayank Mamtani

Got nondilutive of then syndicated the financing, million, the the include $XXX lastly, some offering. of it. if total And you expected in

comment to versus concept, be broader you're programs on just this range, able BOT/BAL in how the helpful, other partner much Garo. rough would a if deal contribution that Just

Garo Armen

our put at the So in there morning that is release Ligand X:XX. is articulated I relative out press release press mean, this the was or contribution --

that, cannot Suffice provides connection to freedom partners our than say it us details. we with but pursue BOT/BAL to other completely on in with BOT/BAL and discuss pursue any additional this -- So own the financing that worldwide.

with And partners our to advance of and no will to benefit So or puts transaction and in bearing in benefit and of opportunity with other absolutely And in transaction our the position the the exploit be, course, our on beyond for Ligand. that BOT/BAL. that for potential the collaboration of ability this are both this the ourselves. In was I economics that that, -- particular believe by defined, company, are of a press partners restrictions any superb words, release. to BOT/BAL we commercial has future

Operator

of Jefferies. Your next line question Shi Kelly the comes of from

Unknown Analyst

is Shi. half. This second catalyst the about is on My question in the Kelly Dave for

Can be and provide data in said should lung, of second number pancreatic number you details? we kind what there of of half. melanoma, the expect those expectation, and will in data like You a patients

Garo Armen

Okay.

data the not conferences, on will provide clearly, So the answer that. can the no. But with hazardous, to present wouldn't our expected be you a ability to we was it data is if talking that be I in specifics compromise

the have to we're see we'll as with indications. data we're seeing encouraged matures, number So very what a of across

As that we melanoma, cancer, and pancreatic even before, lung sarcoma, said includes cancer others.

So patient have to and make the please be in to allow appropriate also opportunity and and the present disclosures an publications. us data to conferences review

Operator

Your Phipps next William question comes from the line of Blair. of Matthew

Matthew Phipps

Ligand Congrats on the financing.

Just Ligand. come wondering, that trigger that additional decision? the that is based that decision? purely $XX can anything can million from Ligand's Is there Or on

Garo Armen

Yes, Ligand's it based is on decision.

Matthew Phipps

Dr. maybe consider registrational a melanoma point? And O'Day. of that's the on LAG-X monotherapy, standard Great. that and be to different PD-X for trial front line this or Wondering PD-X versus CTLAX care. front The slide line PD-X on at PD-X you trial if the then --

Garo Armen

that the melanoma of experts foremost Dr. Steven is on one our for question O'Day. world's Perfect

Steven O’Day

I question? quite of the get Matt, it. the clarify So can you piece Again, didn't line first

Matthew Phipps

Yes.

So there's your melanoma slide you guys first-line a registrational care. standard first-line versus says new study that deck in of

of curious because of that there's I-O consider there. to now X out different right regimens you maybe Just be care standard kind what

Steven O’Day

X. treatment or of as PD-X Well, monotherapy, know, line between split CTLA PD-X you is front Yes. LAG-X the PD-X sort

PD-X that weeks refractory refractory I This a presenting months. think matures data as what it obviously, is refractory in is and see forward later discussing what and and a PD-X the we this coming to year fully setting. setting. we're CTLA-X BRAF and going need And

if on the arm lead the would So have sort comparator an depending in first-line and trial. setting. there of that path, discussions, obviously, confirmatory further Again, to best data a on is strength FDA would of accelerated advise likely to this the the it

Operator

[Operator I Instructions] lost -- -- the all from line question Your comes right. next think we

we next Gabriel have question the from Kims. So

Unknown Analyst

a you Congratulations anticipated And had then the say Could just when Ligand the follow-up. on date? financing. closing I is

Operator

hear we can Yes, you.

Garo Armen

think I mentioned expect we this transaction close to the month. we that

Unknown Analyst

end to of of able provide Wonderful. count, or share current in quarter then are Okay. And count? an you share terms

Garo Armen

was something I the me, but have like this, Christine, don't have believe the you share share with into all million, count? it exact do going I of that. count XX

Christine Klaskin

morning, XX just million. you did it's this on our filing. can over XX-Q Yes, our so And see file that we

Unknown Analyst

is okay, And Okay. wonderful. also that --

current that's So share well. the as count

Christine Klaskin

Yes.

Operator

no over I further time. to will turn conference are this at Garo the remarks. Armen for now There questions the back closing

Garo Armen

patience. Thank much. you very for your your you much very and Thank attention

a know, conditions we step were about announcement you is strengthened, what shareholders that financial our get is first strengthened. number concerned be our process. I very balance how in would today's to able of expect this our sheet the As And

And very months, sheet our to expect I of to activities the pursue that finish you weeks, we additional so will allow very see strengthen important line. throughout next balance Thank BOT/BAL will mission to much. and our us the be able getting

Operator

Thank you. all does for That conference conclude our today. you Thank for joining.

You may now disconnect.

Agenus (AGEN) 7 May 242024 Q1 Earnings call transcript