IGM Biosciences (IGMS) 30 Mar 232022 Q4 Earnings call transcript

Good day, everyone, and welcome to the IGM Biosciences’ Fourth Quarter and Full Year 2022 Financial Results and Corporate Update Call. Today's call is being recorded.

At this time, I would like to turn the call over to Fred Schwarzer, Chief Executive Officer of IGM.

Thank you, operator. And thanks to all of you joining us on this call.

I'm by IGM, Financial Tahir, of Dr. Officer; behalf joined Misbah today Chief On Medical Officer; Chief Takimoto, Chris Dr. Chief Keyt, Bruce Scientific Officer; and Dr. President, Harler, Beth IGM Inflammation. and Mary Autoimmunity

as Please on a and discussed most about as on filings events. forward-looking including well Actual about note those differ be in Form various future plans, call recent with materially risks may as uncertainties IGM's forecasts including Company's statements of other annual that statements SEC. and expectations XX-K results will result report we the its this the making and

represent March statements, law. statements disclaims except and forward-looking any IGM's XXXX Company by required Any views as today, the these as XX, of obligation update to only,

will available website, a the call, replay this Following be on Company's www.igmbio.com.

few turn you I IGM-XXXX, on I update remarks receptor introductory results. clinical would XXXX like the X will of agonist over take to and Misbah's will to through Misbah our After you development to financial a with Chris call death then update, our antibody. start

Beth will Imvotamab you plans diseases. for our and autoimmune development Mary Next, on update

cell and generation We our back myeloma. IGM Chris two the targeted discuss IGM-XXXX, candidates over IL-XX oncology recent will CDXX product immunostimulatory antibody cytokine; it for to most in T our next to CDXX/CDX our turn engager, then a pipeline, IgM-XXXX, multiple

address an to Looking back, antibodies with colorectal for FOLFIRI for our targets in with into transformational IGM-XXXX, important develop receptor first entered IgM treatment antibody, we continued of X a IGM. particularly year three also the clinical agonist and collaboration targets. death cancer. development At of XXXX the Sanofi Throughout autoimmune year was the combination oncology the we the end quarter, of novel three to agonist

cancer. with These colorectal efforts into from IGM-XXXX we to have in metastatic, pleased move with cancer decision immediately second-line, is combination data of as year. colorectal provided and a second very this clinical the bevacizumab, standard-of-care development of FOLFIRI randomized which are data have basis the our in announced in in January for we We seen line the those study

randomized improvement chemotherapy We show arm. survival that significant will the standard-of-care relative are this a control hopeful progression-free study in to

announced treated we study. patient first randomized have today, As we the in now this

in of also T-cell of during understanding engagers XXXX such great our progress potential in treating diseases. role and as the developing We imvotamab made autoimmune

encouraged are field for have in efficacy We we XXX an autoimmune at in developed that studies engagers safety the disease. be may expanded factor through in imvotamab clinical of our by and T-cell safety lymphoma, data and important milligrams non-Hodgkin's believe differentiating new exciting imvotamab that profile the we a

IL-XX we immunostimulatory expect Already Building and targeted on hematologic be platform. used which study of for success our treated have of malignancies. IGM-XXXX, an IGM’s this the first patients expansion year we an solid be the and in in for also clinical treatment our XXXX, year, with validation IgM could of that will the XXXX important cytokine, patients

We are particularly as CAR-NK the such use therapies combination cellular with to cells. IGM-XXXX about and in excited CAR-T potential

more IgM CDX of potent who which for a myeloma, including hope been form we We be initiating IGM-XXXX, and our also anti-CDXX daratumumab. studies with multiple will bispecific safe previously x are for treated of therapy CDXX have antibody, patients

diseases and file and to this studies applications imvotamab plan also drug multiple in beginning initiate arthritis. clinical new rheumatoid for We investigational lupus autoimmune with year,

review to turn XXXX. like I'd to At the over our for financial point, results call this to Misbah

Fred. Thank you,

filed results on with the press and issued in read provide year-end SEC. brief I which financial can financial call release our on the to today, overview, the addition fourth will prior XX-K, our you to detail our this and In additional quarter in call was

financial position. in to fortunate be a are strong We

in a raised XXXX, million Sanofi and gross our from $XXX public $XXX on offering. collaboration In of related payment we to follow the million an equity agreement second of received quarter proceeds upfront of

As XXXX. XX, a and result, $XXX.X cash December totaled of investments as million our

development fourth the million. $XX quarter, and expenses were our research In

XXXX, R&D million. and full for administrative were XXXX the full $XXX.X the million year for million XXXX. the fourth $X.X for $XX.X For year of of Collaboration expenses $XX.X General XXXX. the were year XXXX were and million million fourth expenses quarter the full revenues and for quarter $X.X

net Our $X.XX or $XX.X quarter fourth for loss loss was the of of a share. million XXXX per

net full $X.XX a our of $XXX.X loss share. year was per the XXXX, or million For loss

the Turning for now to XXXX. guidance financial

between GAAP million non-cash XXXX estimated $XXX be and We This compensation $XX operating expenses expect stock-based expense our includes million. million. $XXX full approximately year to of

$X Sanofi. recognize related collaboration XXXX, upfront year last approximately full we expect the revenue year’s also to of For million from to payment

to IGM with expect cash providing half with into runway balance approximately investments of of we end in an a XXXX. and XXXX second million Finally, cash the expected $XXX

I’ll Chris, now that, turn call over Chief With our Officer. the to Medical

you, Thank Misbah.

multi-indication, more clinical mentioned, the for excited that Phase a As broad multi-combination about than patients. profile FOLFIRI in our in with combination Fred the patients safety seen date and with have activity and clinical XXXX chemotherapy study, of we very announce the that important our was standard development dosed in am regimen year pleased X very XXX now to I IGM-XXXX cancer we’re we’ve to IGM-XXXX. colorectal

overview cohort, which that corporate safety we showed data our in available To in from to January, our from profile alone. that these FOLFIRI shared comparable initial is In our broadly data presentation. summarize, expected encouraging chemotherapy detail was an current combination

on of Grade drug substantial IGM-XXXX FOLFIRI seen Specifically, majority activity with Grade multiple dose clinically colorectal at related hepatotoxicity patients only elevations observed, drug our level that seen. of The have progressed X milligrams with promising FOLFIRI. of were in related X have patients metastatic as no signs been confirmed X responses who had prior even transient and significant enzyme we with previously combination liver in with cancer and far treated were kilogram thus per

to plus care is treatment have current second treating encouraging progression-free and patient which These in us cancer. start standard a We with line progression. fourth line with of encouraged one FOLFIRI over for continuing saw third without the patients also survival colorectal for patients year data bevacizumab,

am not the toxicity that seen we’ve we have with I addition arising additional of bevacizumab from announce to pleased and to bevacizumab XX treated nearly any patients combination today now in signals combination. early into proceed encouraged bevacizumab plus the and minus in immediately safety line and colorectal us observations randomized to or FOLFIRI second a study IGM-XXXX These efficacy of clinical cancer. have

today are dosed to we the We have clinical patient randomized pleased this now announce that trial. in first

death the of in XX IGM-XXXX monotherapy We’re showed analysis today multiple and with also patients cell our treated as excited combination to analyzed. patients caspase-X in that levels XX increase announce across both dose post-treatment in of consistent a biomarker

website. the cohort tested summary levels overview milligrams is XX a per X our biomarker to has combination of study. randomized available In corporate on our dose dose per an us current addition, A two seen kilogram. dose-dependent to increase and deck led add these signal at data of highest additional kilogram in This our XX slide was available milligram

currently groups, plus is patients of to or amended care to chemotherapy alone. kilogram XX standard protocol This IGM-XXXX or with either being randomized FOLFIRI X per bevacizumab three of milligrams

Our survival as will progression-free for study secondary rate primary this overall endpoint be survival and endpoints. with response

to the recently topic. approval accordance randomized this We guidance with released pathways potential in FDA on are their exploring with accelerated

date, in our We that any dose been now treating toxicities To observed there in birinapant. combination birinapant fifth have escalation today cohort. also limiting announced are not patients with dose combination we

myeloid venetoclax the subjects our IGM-XXXX acute and we’ve azacytidine today announced patient that We in combination in with first plus leukemia. treated also

as also IGM-XXXX with agents chemotherapy with of these we’ve cancer a Finally, to evaluate expands. our combination of types. in preclinical IGM-XXXX more extensive conducted variety with combinations plan program studies chemotherapeutic or clinically different in We other one development

about Harler, Beth the our diseases will At for autoimmune Beth? clinical to this interim development as President and be will like imvotamab the Autoimmunity clinical going Mary to in autoimmune clinical program. point, in turn I’d Mary diseases Inflammation. call our development our today’s sharing efforts the will forward, of be NHL leading she and be focus Mary over Beth imvotamab updates

you, Chris. Thank

As B-cell important available are the and We an which bring is differentiated offer therapy autoimmune therapies. in readily and announcing encouraging a to with safety currently think deeper depletion in than that for engagers area could there of a we think you offers anti-CDXX profile new activity exciting achievable mentioned, opportunity compelling clinical accessible imvotamab, disease. we data T-cell forward some

and encouraging imvotamab of recent milligram Also, XXX evaluable treated in evaluable autoimmune Phase clear Phase overall using you in non-Hodgkin’s patients dosing it syndrome terms disease lupus. about of the Phase have XXX patients titration XXX these X that in We studies. some dosing of our and recent therapies or the overall with our Phase may B-cell CAR-T milligrams X cytokine may X depletion We data for cost regimen believe that safety, data was cells very safety either was XX% and as logistics. milligram and lymphoma in recall titration studies, X advantages with today in assessment, hearing safety incident lymphoma treated release over CAR-T announced X% most

cases seen All XXX milligram than in titration and other dose X. were X of cohorts Grade Grade milligram CRS one XXX the

additional numbers today, treatment may small currently very and We patients also announced the although, on patient respond. are

imvotamab small assessment. lymphoma most studies combined efficacy our treated a Phase milligram greater regimen, a rate with achieved patients X too B As or large evaluable Phase of numbers in weekly XXX the titration the assessment, make statistical although, DLBCL recent has dosing of response are than cell patient data X overall complete diffuse XX% the and to

continues – milligram appear the DLBCL be in XXX to the lower to appears to be dose. Currently, rate at response continues

lymphoma, have zone with NHL lymphoma, large you follicular all As previously announced may lymphoma, that lymphoma. and mantle B four complete marginal we imvotamab responses subtypes, seen cell diffuse in recall, have major cell we

not in of what to it’s is it possible observe we in encouraging these points. NHL noting directly disease, couple worth a might While data extrapolate to autoimmune efficacy

diseases. target And rapidly that clearly cells multiple the well-established a B imvotamab data in is NHL growing effectively CDXX demonstrate depletes lymphoma in cells. autoimmune even imvotamab First, secondly,

be engagers that clinical In an believe autoimmune diseases in the combination to tissues effectively T-cell across deep may strong of important believe diseases. potential refractory that deplete range are may differentiating current the be profile of signs We of a activity, significant more we with autoimmune and treatment within these there together factor address to with unmet commercial needs opportunities safety with therapies. pathogenic B-cell will imvotamab imvotamab that medical

in file severe second quarter to or imvotamab SLE begin We we that rheumatoid in RA. arthritis erythematosus to the applications lupus and systemic testing plan clinical also severe both, or in have IND today of announced

also a evaluating We additional autoimmune this later of potential a are application for third diseases IND year. variety

turn back Fred. to over I'll that call With the

you, Thank Beth. Mary

to multiple that imvotamab We autoimmune at aggressively and safety diseases. the developing in profile studies to activity have pleased in imvotamab with with in clinical our seen forward we date, move for are milligrams clinical lymphoma non-Hodgkin's we excited are XXX

needs and potential of Given imvotamab's those in safety in substantially lymphoma late potential as the autoimmune profile, and the autoimmune greater particularly commercial disease autoimmune lymphoma, monotherapy that medical those competitive for the relative markets the and its believe size treatment. than are from advantage resulting relatively diseases lines opportunities unmet we in imvotamab of non-Hodgkin's

announcing today autoimmune a monotherapy we to efforts development clinical that As we cease diseases have our for result, are to lymphoma. in are we and efforts further that imvotamab clinical for decided redirecting development non-Hodgkin's imvotamab

We non-Hodgkin's be lymphoma, and the combination well of efficacy imvotamab. opportunities and efforts for a evaluating on continue position the future partnerships safety believe partner we profile and could will our it of as to for focusing in that NHL combination imvotamab treatment

early the call oncology. back I'd discuss to clinical in to our With development turn efforts exciting to that Chris like stage

Thank you, Fred.

and in excited in we pharmacodynamic tumors. clinical efficacy we're treatment January solid patients targeted to a immunostimulatory IgM initiated As have IL-XX IGM-XXXX cytokine of the safety, with in exploring trial activity of announced the

and in today has We a IGM-XXXX that patients with on broad two first we've which positive or range cells combination the other safety potential drug with for are our cells. We issues. their with that including drugs CAR-T combinations to dosed related NK used cells successfully be believe activity, rely CDX announcing of no CAR-NK

the that announcing FDA IgM efficacy engaging in to study application T-cell refractory myeloma. initial CDXX molecule. engager, the IND or allow commence dose to which trial with and us This also T-cell cleared IgM patients allows has next for x safety our a IGM-XXXX, are We X will our investigate multiple of recurrent us escalation a CDX Phase

have Our a IGM-XXXX and safe more who ultimate treatment. for prior clinical patients it development is to daratumumab potent goal anti-CDXX establish therapy, as for received even

therapy. the We an to form excited generation anti-CDX are IGM-XXXX very by of for next the provide potential

in As release. December you the preclinical meeting of year, patient that cellular samples presented at resistance data lines may cytotoxicity cytokine T-cell daratumumab in ASH achieved showing XXXX cell last we IGM-XXXX in potent myeloma recall with directed multiple minimal and

With turn to that the back I'd like call over Fred. to

over the the of closing, IgM for their thank all year. Thank you, Chris. past In like employees to I'd work of

very to made of about families, patients of most have and teams and possible. We're the the All our principal described investigators, all their today progress that whom make we've important their the their our institutions and progress IgM importantly excited We progress. treatments interest bringing we to as to and your XXXX towards you all hope of we new in our look patients. goal keeping in informed and forward to appreciate

With the to that questions. open operator, I'd for call like

with Stephen Thank you. [Operator first our question Stifel. Instructions] Willey is And from

Your line is open.

Yes. I guess the for taking here. a questions. going Good Thanks afternoon, guys. lot on

to mg/kg decision treated guess remaining on you're enjoying before patients, that the you dose the XX to those thoughts Can the the you in might as or conducted So not you randomized the X. it with at I XX X. X add dose dose just answer any expansion whether with the – And randomized to look Phase any when get may mg/kg treated we Bev/FOLFIRI maybe expansion you've then the mg/kg into the Phase combination a dose the can XX dose? dose guess just I And at at mg/kg have have... I and any updated then question,

Chris, to take that one? would you like

you thank the Steve, question. for Yes. Sure.

increase again major one patients factors the really we're now milligrams this although expansion it per caspase-X was FOLFIRI. kilogram as to data make we and kilogram, did kilogram, did XX milligrams at from the plasma you We add study. that have really X supportive led we formal of when per of was the FOLFIRI. we patients as really combine to that treat aware you're to get we milligrams at very with we incorporate during increase milligrams the of started study. that with showed with in XXXX to that additional three the with in we the at FDA from to biomarker X dose and kilogram levels continued a exploration per So escalation, feedback Plus decision was per the milligrams But to optimization the dose explored sharing XX and did per XX then us the went that the doing kilogram, randomized that monotherapy experience that number and XX

and those that So us study. the things, were the the make data prompted new really to addition biomarker this to

Phase third conversation assumptions? of guess to with X an Okay. know I addition potentially arm follow-up. of that And I then to the your a as change FDA the kind guiding Does the pathway. a accelerated regarding powering randomized And having you're approval

of So about should moving we think patient target? enrollment then moving – kind a as a

Yes.

be the well built is combining is that we FOLFIRI. flexibility, which can of confirm the study that we signal this with But So at our seen the again going study also when actually single it's as dose certain experience so evaluate a impact as looking primary degree written endpoint, free XXXX in the and to have in to arm survival. designed of with is really progression

in and also this formal of stop randomized initiate trial, use approval patients alternatively open regulatory signal the there's a to us strong and this accelerated the to confirm of registrational this the and pick increase allows benefit we potentially that trial. that more of a either somewhat the or expand we early with left as potential each potentially could if over we've the arm, control number things so study feedback on dose arms a terms the get of magnitude a And can we

possibilities forward. all considering we things those that are So are as we move

at in prioritized but you. can Thank in And to, Beth, of imvotamab just just IGM-XXXX real know potentially as disease for maybe for looking maybe guess speak is then obviously disease, well? kind autoimmune your you I AI interest I lastly, getting Okay. quickly Mary

Thanks Yes. No, absolutely. Steve.

about a and assets to As we to opportunities, thinking these therapeutic diseases. together multiple plasma morph very we mediated assets B-cell come T-cell are and excited are engager approaches through lens our portfolio how treating cell may than individual about afford

in such targeting CDXX, CDXX data of very autoimmune obviously potential a diseases the discussed there the support interesting to CDXX well-established as in therapies. – lupus target setting set particularly but utility some smaller, a we As is disease, of

very safety autoimmune diseases CDX multiple chronic own consideration we those think like I multiple I is of looks myeloma in molecule we've the it discussed. is XXXX. the a data clearly management note, in understand safety disorders. with our x Steve, important will such very myeloma CDXX even what important as await human initial that that of in we however as as

only to differentiate studies but other preclinical performing parallel could also in not molecule imvotamab, this potential space. in are We how competitors this from understand

So activity human in that summary, of await lot data. and we a

the Great. Thanks for taking questions.

Thanks Steven.

Greg our Harrison next America. Instructions] is Bank question And you. with from [Operator Thank of

is open. Your line

Hey, and the taking for questions. thanks the good progress afternoon. Congrats on

additional RA, First be the broadly off could indications on applied lupus you autoimmune give choice What and some maybe process across the of to for towards autoimmune color how you decision think led imvotamab? that could the was disease? transition and do imvotamab

I a it's thinking lot Mary that's Well, very a of question spend one Beth, we and think broad. for you. about, time It's probably

leave I'll So Mary go Beth. it you to at

Indeed, and disease – to B-cell various respect as and CDXX in auto-antibody to thank and very a and Again, depletion the the in out you B-cell for mediated established different autoimmune a of approaches the auto may that with target management there how broad look diseases. in well literature CDXX dataset question.

key the that competition, in As beginning investment continued as the therefore were taking company the lymphoma points you commercial in in the that given of presentation earlier contemplated I autoimmunity, choice think change invest environment in in back the of and conversations versus to space, given the NHL regulatory the to rationale place, the of our right? heard level the

target well-characterized things benefit that us a could is depletion. and Those this got that given again front, really deeper B-cell autoimmune one the excited. from the on absolutely are upside that The

all of of severe is what look University at Schett the in deeper publication B-cell the have lupus patients possible in not really at with catalyzed If seen at an depletion, Erlangen right? [ph] Georg anti-CDXX deep CAR-T from XXXX, looking from you five September a that through

And where upon from currently that local hide we continue autoimmune preclinical pathogenic complement we deeper than think imvotamab, because and bone NK can the believe available that which lymph basically deplete nodes, data anti-CDXX, in cells. B-cell depletion the dependent in will of in disorders. marrow, enable sometimes our to are drive B-cells spleen, not and will imvotamab the know local we We reservoirs

that hope B-cell imvotamab So so safety is quickly. clearly but an by a of so our fewer deliver suggested better CAR-T product, profile, data, do the with that logistical deep was we're level depletion will and that lower off-the-shelf and considerations, quite moving excited cost with

place obviously Greg, we I of add that? first Schett go the there got obviously might your that's diseases shown the indications concept Beth after entire of got so So Lupus B-cells place includes modulation, in in you be across signal immune mentioned that Mary in, we might CDXX RA you've with a autoimmune where a with we've question, terms is and and you first a and combination think that to real Those or T-cell you I able can be in of those as and any why might and we get that take the but might forth. out great where very a engager, CAR-Ts But as signs two. more got take where And lupus has the think, to mentioned landscape you of able of with for proof just where out advantages or was efficacy. to autoantibodies B-cells any terms are that not over a place implicated to as place two start think we terms also of paper in of CDXX disease. because can a quickly biomarkers, think CDXX activity earlier go [ph] we Georg RA two, clinical of where places us beyond good CDXX broadly there.

– terms in here. the of really portfolio our with we potential a might what we're autoimmune factor. a is just a here the engagers think really, perhaps landscape important is disease. position broad And be in have to real in of we And our able T-cell in differentiating leadership think be we to we safety So, do most

to add Beth, you want Mary did that? to

you. Yes. No, thank

comments, those critical think, are right. I absolutely

the for make We mechanism, expect to most who I the those past, have currently right, there autoimmune are the in where this these you development lengthy year initial in contemplate diseases space of about a the where of particular perhaps, sense on disease, FcRns even we which is going. are here. could in also We programs think anti-CDXXs inform been right. in studies this for list to potential autoimmune the and going addition patients could the in And CAR-Ts think

right. the not for of engagers as profile is, in indicated, very therapies to we Fred opportunities. We think will range active molecule, that have a there there a last but broad bar a got autoimmunity. come I will is very So this we've of T only back And safety define class around cell his remark, new

place exciting an be. it's So to

question. Great. On looks can you much Great, clinical helpful. discussed narrower other patient. that's a would you just into correlate biomarker that data How a almost seeing are in that response? super encouraging, you every to if expect the one IGM-XXXX Maybe I

Chris, take one? do you to that want

question, Yes. Greg. No, great

very that looking So, obviously we're something this at carefully. is

engaging target you about of how and when think death – when well is target it though, first biomarker, cell caspase-X, your an a really pathway. it's agent think I indication you is the

it's pathway with very so, we informative. telling any a looking and again, parameters. strong this very, really terms is very the early, is can't And it's other the are positive per that the we correlates very information think direct again, most modulating And kilogram. engagement quite data pharmacodynamic draw We're But of so clinical at marker, conclusions in us product extrinsic there. still that important obviously milligrams at the signal apoptotic in XX of how

congrats taking again Thanks all for helpful. progress. on the the That again and questions Great.

Thank you.

Yes.

And moment next question. with Guggenheim. our One Schmidt is our you. Thank next for question Michael from

open. is line Your

be how your seems respond as combination? us IGM-XXXX, in for about combination thanks remind that my just I dose taking on curious you it two. questions. on think us well, so, likely patients progressing birinapant Could Just arm to that. which you to of guys, one updated Perhaps are types to you escalation. had with Hey particular

And affect on the shift program so this here. how think company Does that number development large for on opportunity you huge perhaps Thanks a that, if obviously, commercial in about maximize opportunity you have then for much. could CDXX a that? a of across indications strategy partnerships large board

Chris, why take you So, the and don't question take one. first the I'll second

Yes, combination, regards Sure. study. so, we're obviously solid this in tumors. the just with to And this the study. dose in a dose of birinapant conducting so types all to birinapant escalation we're with And part the patients escalating of clear, be of different we're in

that solid standard study tumor a go is to escalation X on. it's Phase continuing So dose

In stimulator very in was with pathway. on apoptotic that birinapant combine synergy where how take mimetic really obviously in a as combination terms we of strong extrinsic this again a preclinical models as this, of strong well SMAC our scientific, built well of agonist showed could mechanistic might interest the understanding the the

we've in a seen And models. preclinical range so activity of different

where you think is Bruce, a of to know, I we terms little this comment that in to promising. bit want

you thank Michael, Yes, Yes. the for question.

hundreds literally what steer for the but that also we different samples synergy, upregulation are, type is, action mentioned, treatment interested as and you see mechanism tested exciting of you combine might with as irinotecan, And well course, well But any always may us. tumors. is in patient up of indicators cell us the set success get prognostic DRX, but as with is signals, particularly of really have We of which in and do Chris XFU get IGM-XXXX treatment. we FOLFIRI, and lines

patients the still that a therapy. indications. the do and says to But that where in data to the response – studies this we preclinical Now, best and which broad result course, other spectrum going having show the to but we’ll, in studies, clinical our have of when, combination we're see

with that of And question against broadly different the or IGM-XXXX that hopefully think specific and much combination a toxicity. of the we with tumors. additional And solid of very little respect I applicable think no to could lot birinapant be birinapant,

so be multiple forward. that are And going there combinations possible may here

So…

Yes.

you Very agents, the very toxicity no know, that's helpful, with encouraging, if be punch as And that – as apoptotic intrinsic we real we the are and both to a think with pathway pathway. extrinsic one two hitting additional could could seeming important those apoptotic be Michael, very,

in we I models data quite we of pre-clinically that showing of see these. safety intrinsic and have that series intrinsic IGM-XXXX clearly both mean, and again, animal with now where combination a combine vitro Right. have high in birinapant And well. we of body a the really

for cell imvotamab and your it for about perhaps expand imvotamab, say and our to I And thanks partnerships might strategic out for broadly. engagers T question autoimmune, more

of As you say, a number, lot upside with the in at opportunities there in end potential to take the could and large size but a money pursue, are large the of lot of pathway.

opportunity really autoimmune good of looking be to explore to new engagers and So, disease, T a this I for as us think a that thing cell join that strategically partner really was us finding a company. would

are that a long partner if I do, we good think, really is, the and things a different I many Now see. would so so term, exactly opportunities idea will. franchise for think, that to be timing of could we'll what wait But have and large you the

so Thanks Great. much.

our for next question. And next Roger Song moment from One our with you. question Thank is Jefferies.

line is Your open.

Congrats Great. progress broad IGM on pipeline. across the all

two from for is maybe DRX. IGM-XXXX us. clarifications quick One So

X XX and dose also from or study, may, when just higher trial the safety you for on considering and are maybe renewing marker? the you if single-arm your PD mig, report And the you mig test As the additional randomized in data will you the keep trial? would focused single-arm

the about when the of I the lupus also in you noticed disease. talk severe nomenclature your form we And RA, – the for imvotamab, use

the or the into the point, engager target of have. early Just move curious as autoimmune for question the autoimmune It disease disease, stage starting each the will at be you population you. therapy two potentially indication? the we last for you T-cell will real position of line that’s is Thank for what those your disease,

second the hand one Sure. the take want one? to Mary you to Well, and Chris, first take then to off do Beth

Sure.

we’re as study. higher. your question in the as of randomized before kilogram we you’re of kilogram, the XX not XXXX milligrams study, monotherapy high milligrams go Roger, our that and dose in we So about really the per but went was probably aware, And now about part exploring talked per as did XX we’ve

no were and going in FOLFIRI arose. limiting dose, per We dose kilogram that that There XX toxicities define safety tolerated was milligrams didn’t or chemotherapy. true to maximum any a combination up also with signals

we’re program as and activity milligrams the a and that we that really strong is of But doses. So achieving in dose, there that need to are terms feel a the per show models, – issues higher that no feel look that the and preclinical preclinical across experience that exposures experience, the in good there’s we there. safety kilogram we the particularly don’t explore efficacy XX

our optimize get today, how something with really is what about per think at in but X experience potentially open, that really the start we milligrams and to seeing we’re more It we at dose at milligrams kilogram. to leave would We combination in kilogram least per thinking we’re want range. pleased XX in

this Roger, Beth. And is Mary hi,

Sorry.

additional to not there, show there we when made we Well, some I was data. think context and data a of we as monotherapy when produce might the in I think of decision what just would and have additional the question monotherapy

I very the think randomized data. we’re focused on

forward decision just data. point, the decision into date not we you this want present question? those certainly study when with cause haven’t will inconsistent question randomized some Beth, But would that’s at that us we’ve We so. go seen in data to Mary to We’re a seeing Roger. And what move to monotherapy the anything made to second our

No, Yes. Roger, the question. sure. Thanks, Yes. for

correct. absolutely You’re

focusing SLE and severe severe are We on RA. initially

and activity in establish to milder then those initial populations move into is intention safety populations. and Our

is patients So more light expansive approach obviously group the modification of true, through a This both fronts. in on from potential for George that by much as of disease suggested data CAR-T [indiscernible]. particularly this

So thanks question. the for

Maybe for clarification Thanks just follow-up quick maybe for Fred. a Great. the comment.

from what the combination similar. data I So monotherapy is that been believe single the additional but answer have is data, combination, the meant for now I the arm you from doing the also

You that haven’t when produce. you decided will

Yes.

venetoclax arm single presenting we’ll single at be data data point, initial FOLFIRI at on And presenting the arm – combination. We’ll on be decided. some – additional not we’ll combination. birinapant have some At presenting point, additional We be where arm the initial our our still some in on those disclosures we’ll the have we now. combination. data data we’ll when But a on happen, decision progress all of might that those not all presenting on single made right we’re point, studies

it Thank now. for you, That’s Fred. Excellent.

you. Thank

Thank Instructions] is Baird. [Operator with you. Beatty Joel next our from And question

is line Your open.

Thanks the taking questions. for Great.

randomized success is one How from First DRX that study? you the on study. would define

going it to to when I think it, we’ve what talk we in to know we’ll more certainly mind. got Chris see leave I’m about but it

Yes.

Yes. Joel. thanks, So

that’s So with survival. primary one that the also is overall be reason overall study designed PFS really The Obviously, why response is though rate and the will PFS we’re correlated endpoint. survival. strongly much looking at more focusing as we on with

– actually at design the potential a an in more led the which as us much to to we track terms randomized data approval, the the has registration current study supporting in now much way. being think registration And accelerated endpoint, – has is that’s a least eyes start what record of about And is really endpoint. a higher of in FDA

In at that studies, gives data for control so be we into kind has design like FOLFIRI colorectal those so. thinking give – randomized terms to of never that the gone – cancer the think will success the second large six substantially but past, months look I kind you expectation arms like trial. we we don’t things our tends if expect is or of five, you really that to again, floor those that’s historical need to what and the be PFS targets, specific the better And line and be the to in we where of of better. But what of studies in too we distant where that look not a

mean Yes. for PFS really over control significant are something hopefully meaningful, on I here, clinically a we looking improvement so. that’s

Got it.

Okay.

you’re Thanks issues on a on focusing dose, target? with seeing milligram other great. Sounds the XX that then for more now risk And the of that targeting some also those agent seeing liver we’re the – of is agents there all details. the same

We see see related Joel, we didn’t what that higher issues. emerged based experience, on we is see and would in any around certainly did liver anything issues our dose didn’t any doses. say monotherapy related I toxicity treatment general, that, again, not at

an hasn’t that issue and we in issue it an and future. that not to expect is be would been, expectation don’t be our it So the

said, in dosed, as patients anything there. Yes. didn’t And three we we see combination with FOLFIRI

have see We there. mg/kg too, and dosed did with any some patients signal in XX combination not birinapant

you hepatotoxicity a expecting do study, we’re guess not a but that’s the why expecting signal liver But So signal. not to it. I see safety

you. Thank Great.

next from Thank with Eisenberg our JPMorgan. is Instructions] you. question [Operator And Noah

Your open. line is

our for for is guys, Hi this Thanks taking Eric. Noah on question.

that kind the for noticing line second you’re status. XXXX trial at Just by stratifying KRAS looking of randomized

So potential and is are in to any extent inhibitor KRAS And Thank as based what interested development combinations you. that, part strategy? synergistic evaluating between of you or on activation combos EGFR there EGFR DRX inhibition? we’re the wondering

to pre-clinically also we very the treatment there start, well our in can us see are But there we’re to a in think through colorectal molecular variety things been treatment options. I far have one clinic clear the cancer at that’s maybe, subtypes. that So impact molecular profiling starting different the space, should is big least obviously, and work of we obviously of – mechanism, a on different thus

we space So expect KRAS obviously terms we look again, and obviously being to further, start That numbers those a this program. just in the where would signal having what active go? seeing of impact this see subpopulations. can if about as else we as do be to this we really on exploring We then and we and we wild-type, where differences far, small KRAS said, confirm we’ll we really all we other any the at broaden but be to we’re to mutant, expect maximal combinations think so in disease and do in open don’t expect go

now subtypes. question least I and don’t try that maybe you broadly at was there across and kind know, And can… there of mechanistic more development the is molecular different go to a plans But

very a area but – mentioned, could both, good opportunity a opportunity it’s of is KRAS No, We but Yes. the is good we’d positive question. investigating haven’t – we a to combine due pre-clinically. as there It’s a seen we’re work in active to likely an or still differences Chris certainly negative research.

Thank you.

Abrahams with our RBC Instructions] Capital you. And Thank [Operator question Markets. next from is Brian

Your open. line is

on It’s for Thanks. a the Brian. guys. on Leo pipeline. I maybe Hey, couple had

doses steering maybe there think when with we data So given And where’s clean we’ll starting safety guess, patients? going enrich? you you also of do could what IGM-XXXX. your this I Can be think active. Is you PD-X you may low terms active? you to two get in activity. strategy well. might what more types can And do then maybe as in doses is reach, still have dose the then, a cells I preclinical you had a or expressing follow-up most to talk want And tumor be you be And think where to on data the target about initial IGM-XXXX

you the to take want question? Chris, – that

Yes.

that and in preclinical the – And and think would X, of low escalate. preclinical that one obviously, in efficacious clear a generally expectation make maybe say in the the entering estimations into that when data, dose range is X a be Phase will dose exposure terms things would’ve our is. you study, or – I in of we do we obviously we going of so level of sort we actions So the models. things study, where start safety we study reasons Cohort on saw But X start escalation based we for we

think target. the shown that hit our a molecules is But the agonist and other factors to certainly potent have I we’ve been IL-XX able

but that about even start at And dose have our we’ll But seeing is lowest pharmacodynamic we’re talk there future think to off effects that the biomarkers levels evidence at So the dose the we’re good through I safety the and potential we start at looking hitting even is we the think also certainly lowest good, the levels. in the in to study. about could we’re more target this. a

over IGM-XXXX the it. you might few the on may have some Got and And one multiple are offerings? now, BCMA to is How other there’s advantages the space how then going a be thinking GPRCXD. of bispecifics play you different in in about myeloma that Thanks. obviously, IGM-XXXX,

next over. quite would as Maybe let differential But like a least other pretty I’ll we develop with we’re differentiated CDXX as it molecule. We at IGM-XXXX start bispecifics. the that those to way intending see see to as Chris from generation and then take – hopefully this

dara against to may can we those and work then can like show of up. assuming maybe seen that fast who to we order as some would dara safety randomize previously as so And dara like to efficacy. and We’d patients than and moving we better be in potentially eventually

a here that? to – next generation is hopefully IGM-XXXX want focus the So CDXX. you for Chris, add to a

XX T-cell Yes. that, CAR-T and not antigen it BCMA the or a There’s but resistance important differentiating things. through is of the cases bispecifics to is of and – tell those reported space bispecific CAR BCMA obviously, all have you can cells been you therapy BCMA the there’s And lots a that factor. an bispecifics, in actually fact we’re are And multiple of into I myeloma BCMA, space. crowded the XX with about then CDX coming

it’s T-cell not targeting use CAR it BCMA clear, could necessarily bispecific would or before use you And that the use you to a so you’d afterwards. want

many too, out CDXX So handful bispecifics for there myelomas There anywhere but other not are in the BCMA. there. it’s fact, a as are fewer near crowded bispecifics, of targets multiple as

then major targeting So we already to is differentiate a and way CDXX think think agent to And there. about potentially a class. strategy our in tenant has to there’s as this here, this outlined really best that the Fred

strategic of at really thinking point. this driving our So kind that’s

for lot the Got Thanks it. Makes answers. a of sense.

is Truist. And Instructions] our from [Operator question with Asthika last you. Goonewardene Thank

Your open. line is

questions. provided today. Hi, guys. taking And I all Thanks for colors appreciate my the

which follow of was have increase then with made level then what four to was which So profile surgery? Chris, curative increase, expect couple And and that. you measurement us caspase-X on-treatment subsequent had related to in again, have when do couple in on-treatment got you ups. the where increase the those And the you in you slide change to that, PRs, the tell What cycles? I patients that was patients caspase-X baseline do perhaps five profiled, a Then questions On then including your – for you here. at one the that a cycle, a on went noted had you patients? four I of profiled,

for Yes. Thanks Sure. the questions.

data. are So so this, these just we’re slide, on our to clear normalized doing what be biomarker

our So not levels at surprisingly from vary highly patients. plasma the caspase-X in baseline can

So that data what we’ve normalize we’re relative the done show to actually then sample, is showing and you taken here. and one the the change that pre-treatment

we’re that And So during in study. we who we patients levels showing actually the second what caspase cycle. the cycle, on caspase-X see first the monitor actually the in are levels change is maximum here

vary could somewhat at points. that time different Now

we though, in a immediate to with see rise the caspase-X do levels treatment. very tend So

in that’s But our consistent something up very it’s are the in timing the it of some this, that on all in the So patients. of we’re – patients essentially is across seeing that general treatment. but goes noise there to

Got it. And then…

looked then those we’ve that And at also patients. I’d specific

yes, And Oh, yes. then…

in increase caspase… fold they’re How relative

terms have so again, draw to can’t conclusions. any in we clinical seem so and small numbers, really patients data. that those of we at have Yes, see looked shown just things We’ve And it’s those things. benefit

move to although anything we this now, forward. to that we’re at you and pharmacodynamic this different sort share right obviously correlating with going with as endpoints looking of biomarker clinical study, So be we other all don’t really particularly have in

Got it.

us those patients Okay. colorectal Chris, XX cancer? a XX And X suggests as Was you patients colorectal mean, distribution distribution per seen many can’t kg. – biomarkers cancer the the maybe percentage patients? to the how of some of that, or that color similar been if had Could was slide the mg/kg dose? the that Or similar us tell about milligrams so give you treated that there’s with then I on at what who’ve

Yes. Yes.

no, the answer it’s is the different. actually your to question So of part last

as the all that XX per are combination here with of colorectal you disclosed cancer were with kilogram combination in types, treated because a changes at patients not was So showing tumor with we those X patients combination And these per one that a actually with milligrams milligram you And expansion the with combination well the three X that the in patients dose patients, are in patients kilogram with previously of escalation as FOLFIRI, we’re cancer milligrams patient. colorectal kilogram that in only which treated of arm. per being cohort monotherapy were the showing we is biomarker at data FOLFIRI majority were in FOLFIRI, FOLFIRI. only that the of

IGM-XXXX much at key is But being the question we’ll this that how is And obviously FOLFIRI in this we is with being an things much, what our a driven being of said, one look when molecule, particularly that change for how how driven the is of patients, biomarker combination by our much effect much but see just again, of by of on small numbers, chemotherapy. this dataset. say, marker. chemotherapy We and don’t

have measure specific obviously randomized control So we of to continue in IGM-XXXX. arm will But study, the action it and will is our for this. more we we likely think a

have question. to address will you more with We definitive data to that share really

Chris. for Thanks last one you. there, for the I Great. got Fred, call

year. You to Phase Can of this said using presenting one different data the I’m the here easy I, some air in X cohorts. at them for least quotes study point, point say from some at on

talking? The imvotamab you What are study?

IGM-XXXX. No,

IGM-XXXX.

those. We’ve really – running shortly that’s a focused year we’ll decided. honestly at been our for you’ve a a that biomarker question I’m these I that up on least we of – being and have I But been focus. think. just really saying is randomized getting study honest And have data made in the not asked and that. turn have we when to new would that would not be say hope, we We sometime do decision this some would reasonable so

guys. I appreciate Thanks really Excellent. questions. the

Okay. Thank you.

Thank to the would closing Executive the you. now back Schwarzer, conference to like Chief turn Fred I Officer remarks. And for

we on greatly you. to us joining all like you and I’d thank support. for today’s call, Thank your appreciate

concludes And call. this conference you participating. Thank today’s for

disconnect. now may You