IGM Biosciences (IGMS) 26 Mar 202019 Q4 Earnings call transcript

Good day, everyone and welcome to the IGM Biosciences Fourth Quarter and Full Year 2019 Financial Results. Today's call is being recorded.

At this time, I'd now like to turn the call over to Misbah Tahir, Chief Financial Officer of IGM.

Thank you, operator. Welcome and thank you to those of you joining us today to discuss IGM's fourth quarter and full year 2019 financial results. to are financial Officer; Fred afternoon general to Bruce this update corporate Schwarzer, me discuss and the provide Keyt. With Chief Executive Officer Scientific and Chen, Medical Chief Dan Officer. Chief

forward-looking those well about IBM's risks result expectations note we'll please Actual begin, future and of discussed and plans, company's this materially results we statements be various may and Before differ making in including the call statements about that including events. forecasts uncertainties on annual a as as to represent the other views XX, report the on required Any recent as any March update as SEC. XXK most except as with its by form today obligation company statements disclaims and filings forward-looking law. IGM's these XXXX statements only of

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

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

thoughts everyone's this that Thank pleased relieved of afternoon, you, and at of quarter results. us at pandemic you reported infected. they on forefront our very for have our full you is call thank date none that been Obviously year joining and fourth to to to XXXX employees financial discuss time. and COVID-XX and have Misbah. this advise We're IGM everyone the concerns Good the

that However, adopted IGM clarity. team, policy spread a home to we general reduce would risk infection any further pending have the such among the work from

of hopeful assess accurately we're will can the and as modest. timelines long-term pandemic, medium our us the of none While the now be impact current of COVID-XX that on impacts

on a timeline. several months, might that to of and were for expanded the our start greater be or we if level continued expect Of impact restrictions current to see course we limitations

cash will position from Misbah reserves a strong as discuss in Fortunately, perspective. we're our

overhang year, XXXX of can the cash adequate engaging us cash T last results COVID-XX year. IGM-XXXX, this portion the about the the steps end situation and CDX to this financials the of have we trial We appears pipeline potential runway. towards eager we're excited take the of Phase to cell concerning Notwithstanding dose later of that remain X antibody see and as clinical by extend our of we into the CDXX of to clinical escalation our

hope may clinical that the We in for of a treatment to of prospects agonist lymphoma. will also prove IGM-DRX Dan of the in cancer trial. to by class range or and continue broad shortly status update the believe for types. that antibody excited refractory have best resistance the as were antibody which IGM-XXXX application a current be We will treatment provide an to IGM-XXXX we of non-Hodgkin's

will discuss Bruce and appear to shortly, an track As profile year our be on remain toxicity this IND and file therapeutic preclinical we for encouraging. IGM-XXXX index to very currently

targeted for our IL-XX as the Finally, cell we're about that excited will prospects IGM-XXXX antibody. describe immune stimulating Bruce

expect file We an product next for IND candidate to this year.

So decade events all and relatively inventive of been IGM these now and the made engineering dedicated, pace by coming focused on of antibodies. effort has enhancement are This and creative rapid IGM. a possible exciting progress at manufacturing pipeline for

of them classes five class antibodies units relative IGG the binding targets surface units strongly XX antibodies in only antibodies. believe we for binding IGG the enable the two drugs that have but units IGM and IGG to antibodies. with of based, antibodies with are inherent Nonetheless, are the more of lots natural in buy of antibodies IGM currently one binding antibody are market body, as all only you antibody antibodies IGM IGM to reminder the and a compared As XX all your cell

may efficacy compared format, have cancer the team antibodies. to which certain safety we Also a and developed when bio IGG treatment unique antibody our IGM in has advantages believe specific of

and call of the over is At pleasure our point trial. describe clinical turn the IGM-XXXX current my Dan state will to this to who

Thank you, Fred.

patients multiple non-Hodgkin CDXX a cancer happy on that designed as affinity, expressed lymphoma. and with IDM cells IGM-XXXX, at protein high non-Hodgkin's cells and course T-cell lymphocytic high So ability treatment as engager IGM-XXXX engineered is be the for we're the IGM first biospecific CDXX is cells the surface lymphoma including very by in CDX antibody commonly leukemia chronic positive of of our with levels. albeit is well clinic to of a myeloma even low CDXX

IGM-XXXX are set strongly expressed distinct mechanisms was cancer T and is cells. CDXX This surface the for positive low possible cancer dependent CDXX. our potently preclinical and on protein cytotoxicity levels -dependent a of T expressing to toxicity. cell eliminate cancer cells very of complement cells. demonstrated bound CDX killing These even In two of to studies cells those cell

of also CDX of levels potent very CDXX again and cytokine IGG observed studies findings cells of IGM-XXXX elimination T cells observable circulation despite safety detectable detectable the in cytokine with that CDX we the importantly, In cells release primate CDXX compartments. by all antibodies. We occurred CDXX of levels cancer by tissue expressing with to by with relative observed based release, no very nonhuman low low comparable elimination in IGM and

This intravenous we lymphoma. the inhuman open label of to with relapse trial intended is assess patients pharmacokinetics and initiation in October our in announced B IGM-XXXX relapsed IGM-XXXX safety, Phase and refractory of cell first efficacy of cell B trial lymphoma trial refractory a preliminary last X So clinical the patients. multicenter non-Hodgkin's

of dose administered being planned protocol. dose part the at is escalation IGM-XXXX a as fixed

City trial now Anderson, sites are and six of health Hutch initial Fred Sarah Our include open Hope, on her M.D. Cannon, they and clinical Dana-Farber.

preparation this and expansion. US to We ex-US also I later hope in open Phase centers for our year additional

protocol signs date IGM well IGM-XXXX with syndrome. gone CDXX of we're has primate our with obvious nonhuman is studies. cytokine the we in the Escalation I. what to with our be happens by release This our mg no and escalate to consistent recruiting to and observed CDX our dose XX to trial able fixed dose dose cohort which readily clinical in currently fourth per been We've phase

performance of the look further from escalation We analyzed as the clinical during and dose IGM-XXXX data is the X study verified. forward to collected, gaining Phase of characterization

yet while our not by While the a do is our recognize have milligram year. XXX this said slowdown goal at summer Phase do the dose by and dose to we COVID-XX experienced significant of not That to X yet experience dosing in begin due have end possible. the we escalation that is enrollment we complete -- the

XXXX of future continue target initial a and this the from clinical conference. at presentation We such to efficacy data safety meeting ASH as trial

call I who discuss this will point, turn and At IGM-XXXX. to will over IGM-XXXX Bruce the

intracellular This receptor of surface you, DRX and Thank Dan. is as as five. commit number of is act is any given cell apoptotic at cell, to a and expressed at on on receptors signaling leukemias they or requires When of three tumors IGM-XXXX are the cross-linking efficient antibody location. bound on targeting well any -- DRX cell. that broad apoptotic on This least signal death range receptors lymphomas. which given IGM on solid an suicide a the cell

binding Now with especially binding demonstrated IGM cancer cancer antibody signaling to receptors with that antibody enhanced apoptotic of an sites fold X,XXX XX an format seen induce antibodies In our DRX significantly cross-linking multiple in IGG is for cells an in types. has resulted killing been DRX greater to with on potency productive domains. the same appropriate That preclinical this cells. IGM its increase and studies cancer compared

indicates we and preclinical our a safety strong excellent efficacy. to efficacy, In preclinical that current for signs of encouraging data of have the therapeutic very safety an addition index versus IGM-XXXX profile

treatment patients we year So with an of and the for initially to file for with IGM-XXXX are the currently tumors. this expecting IND US FDA solid

chain hope Now have also this chain-based our This an will cancer serves attached to we to surface targeted positive anti-PDLX product broad such specific IGM-XXXX, stimulating to which the the cells. our PDLX oncology applications. case IL-XX IGM I stimulating display candidate which another would of of IL-XX demonstrates novel stimulating self J the of as like IL-XXantibody use technology. In on J introduce immune biospecific is immune immune the antibody

our IL-XX important cells the natural roles cancer. T type Both targeted killer cells cells of called in cells. of CDX In these treatment proliferation studies preclinical of also creates T play and cells strong NK or killer this

We are IND XXXX. molecule file US FDA on with in an currently this the expecting to XXXX

Now manufacturing to finally with we progress efforts. continue make our excellent

manufacturing improving each our of on run. completed now GMP yields run have We IGM-XXXX with fourth

manufactured meet least XX we've trial contemplated needs next for currently IGM-XXXX addition the at clinical our In enough to months.

also programs and expression pipeline We our growth and continue part as on to improvements antibody make yield the with and process of evolution our IGM overall progress manufacturing of capabilities.

at To of in Mountain that the GMP out site to we facility our manufacturing in here View, build end process California. a preparing are

to expect begin to to once COVID-XX are build We restrictions out related lifted.

from turn financial Now this call I'll the review to XXXX. full quarter Misbah to year over results and for the the

Thank you, Bruce.

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

a for initial was in million and fundraising of series very September private in raised offering XXXX gross placement in strong our proceeds of public $XXX We million gross IGM. June and our $XXX proceeds year in C July.

XX, $XXX.X we position as to December are result, XXXX. in fortunate a and financial investments of cash As million with totaling be strong a

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

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

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

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

will our generate to By as trial for guidance the to Turning to our of the file ID Also now for an financial and to IGM-XXXX. end of in noted data View from manufacturing to look buildout Mountain the facility. R&D we'll Bruce our invest XXXX, our programs. ongoing this GMP goal start year IGD-XXXX initial continue we

we be excludes the stock. non-cash million $X This stock-based operating million. approximately result, year million on full expense based estimated expenses trading our range a our As and of to XXXX between of recent non-GAAP $XX compensation expect $XX

and stock-based non-cash expense $XX expenses expected Including million. are our between be GAAP million $XX compensation operating to XXXX

XXXX an IGM expected million expect a with XXXX. to investments balance over cash and also We of cash end $XXX into runway providing in with

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

Thank development IGM team in as that work. to I the to moment global IGM and they just established leaders take thank you, Misbah. I'd antibodies. briefly have believe research IGM a their engineered of the for like the excellent

IGM smoothly clinical of now X IGM-XXXX application escalating our is engineered inhuman trial. The dose phase antibody in first our technology

the in our Our the year. antibody expected stimulating is DRX to expected year clinic IGM-XXXX this immune IL-XX into IGM-XXXX to move follow is antibody into targeted clinic next

potential believe change our to forward look we're your keeping the that IGM and course of realize interest to as greatly the therapeutic and all We antibodies you antibody of well-positioned we towards begin We appreciate development. to to IGM to possibly this in progress mission. informed

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

question [Operator first instructions] Stifel Our Stephen Nicolaus. comes with Willey from

You your question. may with proceed

for point taking the questions and maybe just was of Thanks clarification. the on congratulations progress. I

So not up terms dose to of are regardless delayed of you whether additional kind of here your the ramp year-end escalation timing going some to to commit just in gets presentation or potentially ability cohorts? a of

would update expectation that much Fred. end that say of uncertain suppose year learned and I our intention. change by very market stand Steve, I on clinical in times but could we're is to so our current this that the we we the is very that where we've this far as in trial. will is and what the

what either of sounds molar about dose cell terms -- that cohort the primates you're a just nonhuman Dan terms B buys in in depletion? in question for Can perspective you maybe And you mg the of fixed equivalency Bruce from dose it now. XX talk like Okay. or

turn Sure to and don’t preclinical question since question. a it's why that over Bruce I

mg peripheral peripheral how cg next or Right of so circulating those B had functions question course next tumors at and be on site occurs the depleted point cells per cells monkey XX and question, that as been in depletion a of seen of that B of model, cells well course. in in a will peripheral cells the clinical biomarker XX% a we the sense that on at B order of the the that and normal at circulating equivalent had the Steve monkey more B

just the know the about timing associated -- talk little some front with think then tumor antigens just pace of programs lastly enabling various also XXXX the CDXXX, guess maybe the a cadence filings. guys how and to And programs Can CDXX. Okay. I NexGen you happening things about of at to have after the those you which is progressed is those what through dictates talked other Thanks. studies. those I on talked about with other respect biospecific I you and IND go wanting to what IND

Sure and this say possible. nothing is push would XXXX wouldn't at would this over guess in a that we've XXX that with quickly indicate Fred. we as I second I'll that XX turn to Bruce seen point in question to I that forward want as but

So limitations we are as fast of we can preclinical subject course. those to as pushing programs current

Bruce, So want you talk about this?

we we're Fred. I for the moving on can the platform. encouraged both programs. but -- vitro that program agree they in very stimulating looks data are after you. in Yes the possibly They immune the as in likely Thank as now with IND an right of year, fast and slated are vivo and that those we same good year

So we're programs. moving ahead on full both steam of those

XXX type XX we're might seeing that same you and XX. on release on the that Bruce mention saw cytokine preclinically And of we on data

Absolutely Fred.

very with great in without in studies in both strong vivo get and the As program responses. XX we're without well program preclinical as cell the we CD-XXX detail program in our attendant we've tumor with profound we well described seen XXXX vitro release the release. efficacy as strong, CDXX same cytokine and anti-CD the aware killing see and potent both and We've cytokine

of really we're safety of platform. confirmation advantage this So a seeing the

comes with question Jefferies. next [indiscernible] Your from

You with proceed question. your may

for Thanks guys questions my you hope are safe. taking and guys. Hi staying

I presented everything X,XXX just I -- fluid can or you line want your it see is goes expectations this on XXXX and that you're plan later with So at you at dose know doses could XXX and think you according maybe likely more observe if about situation, to dose not the ASH don't we're year? do the being and the start milligrams mg if XXX thanks. data any but a it's to going clearly program, see cost, to we Ash, talk

time over and to still to that for I'll going Thanks say Dan into Ash hope point we that and I'll X,XXX can he a this with top the but we're more detail. mg through question. it at of take just that be go line by turn

Yeah question. Darin that for thanks

So we time of milligrams at by X,XXX are IGM-XXXX the targeting being dosed having level dose ASH-XXXX.

lot a can course Now now happen then. and between

our pace what right of continue but the go, believe to it the the onto enrollment there that is is continue would terms In like our we now to at we to continued -- we X,XXX see get study through ability cohort. we milligrams

determine data enough XXXX ahead to Ash a of will X,XXX whether any cohort. meeting data at the able we're -- that XXXX Ash ultimately includes Whether do presented like milligram

X,XXX milligrams follow-up. very from could generally in safety imagine whereas quickly can You come efficacy requires

that is potential So we potentially you gets imagine that would what have depending determine enrolled, for that presentation. when cohort there on will

Bruce, compared on the on Okay. your And Can what mentioned about manufacturing months, terms think a also you manufacturing are levels this remarks I question fourth the and assumptions of then in about of the run little XXXX prepared maybe assumptions bit thanks. mentioned yield Are runs or yield run. for I IGG for the dose in fourth on talk the the duration based a your to the earlier XXXX for you months. and X,XXX on yield milligrams relative in just assuming XX and is have based you dosing level you lower dose your guess of it sufficient next that you doses XX at to

Thank [ph]. Darin you,

going me and So to We've don't back we're see that. improved runs that question. steadily and done go four to I we've first let doing your stop

the better and yield typically get us that since we've don't Those yields standard very good our range of and the a programs other IGG. in Our puts types IGGs. Roughly biospecific run yield better. of of doubled have first

indicated, improving in all along. the So and as we'll be much range we'll we be very

and at be of this intended take level mg with could we to inventory. expansion high in but comment half XX for available did the dosing trials the least to I at clinical we supply I be that we treat second and where doses. XX the on would this to you the and at to able will a able look currently even Dan like the duration, inventory question Now and handle in X,XXX on think escalation

Bruce. Yes thanks and

duration think of will don't XXXX what as -- of I about that have there not think realize I are know and from we schedule the to therapy project those make in data therapy duration schedule dosing and we and still of in dose that determinations. to ultimate program enable clinical us built to we fact think this that the be help and coming we trial

as not how schedule long forward just actual we take So treat. as dose well but the we that

to of on off potentially in built both further was assume about would the but frequency case, initially the protocol of base also to we target the adjust duration and we a that six back written provisions dosing that up also of months, therapy. As dosing to

will that phase is Bruce I to a is think but depend to have I said have think a data right this very So get we clinical X. that itself lot what I on supply positioned support through us which much the now well

next Your question. from with may proceed [indiscernible] comes question Your your

some all to today. am to to to often. can little be kind on the bit of update, the Thanks really everybody's going of the am of your here. other because that approaches I about earlier IL-XX. terms states I May in call we're for that and guys excited of a here doing some you hear much well go seeing voices certainly thankful XXXX characterize the am good so I

address how that did IGM really simulators? these So immune format work to

is to be now May to start and follow-up. there we ask can further go Bruce then I'll if Dan

for question immune excited you, Thank Dan we're and IGM. very Thank you Right. IL-XX the stimulating Ted. sorry the about

immune first it's targeting foremost and it's course Of cells.

expressing we're able to of IGG. a and cells IGM the corresponding to compared have on one specific target all of with the programs targeting demonstrated we've PDL lower a positive cells to We our IL-XX as

tumor PDLX cells. to So that us even lower gets positive expressing

incoming PDLX displaying to is and and avidity strong course The the of binding IL-XX. cells we're NK to we of we context-dependent only durable presentation not thing but get next high a the CDXT get IL-XX cells of important

is tumor engaging stable cell of local robust and this immune mechanism to on So of the a a studies what biospecific of the activity. a IL-XX in is enhancer display cell IL-XX different durable platform we've preclinical is where this we type have seen our surface

Dan did additional thoughts some the you of want application that? to about offer

we're you by IL-XX PDLX can very imagine enthusiastic program. as about So our

tends the much an of in related for immune can characteristics we cytokine offer really as very therapeutic. think memory IL-XX more than a safer we in have for dosing together in tends us to excellent think also make interesting to for in in T be a cells pipeline push I example that IL-XX some the it to characteristics these and set Obviously IL-XX phenotype a does being of really the modulator. as our so really a it terms a two IL-X development. clinic to therapeutic closely respond

that mentioned I'm platform the finally and coming believer to And present had ability the that for as a cell target also strong stability of to binding in the and on a so IGM Bruce not context. both off it's

the only It's but cell. you cell context. presented imagine to possibly the presented T by cell, surface other they're IL-XX and molecules of presented when by that mean can the often those IL-XX on seeing present we cells dendritic signals a the what seeing IL-XX that's that not T T recall cells like So human is cells so immune response in generally myeloid and that things

IGM really that. And so I to platform us allows the think use

I planning, running think when question that another What in the up that is One do you're ability quick Yeah be. facility like the terms be scale of scale may will that facility and your the just large terms I of will really you fully your thanks. how in if new program. of and

that I'll ask to answer Bruce question.

Thanks Right. Ted.

site. our as it looking call two of we are forward building We manufacturing

two of We to X,XXX production leaders. have put have in plans ending at trains

the So liter X,XXX initially at we'll X,XXX bioreactor out the in for then liters. on build and first coming we'll train bioreactor bring later second

with from next [Operator Guggenheim. Schmidt question instructions] Our comes Michael

with proceed question. your may You

us and a animal clinical at what just Bruce May you taking questions data. dose for would IGM-XXXX Dan activity-based on remind be the coronavirus follow-ups guys the could maybe appreciate Hey on your comment a my you thanks expect couple from outbreak. or

that you that? Dan I'll start. turn to to to question take over Dan do want

you, Thank Michael.

first data So out dose up active and be we that model monkey recall dose dose which level that our microgram dose minimally really to map X,XXX fixed using the we XXX we this and of is biologic around for all the way started went IGM-XXXX to effect expectations that fixed by milligrams molecule that's program all then of the homologous the and Mabel set we a used planned dose.

dose. we biologic It with was increasing So just entire effect. throughout range that observed obviously

so throughout a try And So at simple observable set decrease dose to minimal into preclinical the that that translate cells CDXX believe in we a XX% biology we dose cost for XXX micrograms, essentially us when had B and a that expressing a Mabel to studies -- that observed relatively is this entire reproducible then relatively activity we range. humans.

And thought dose by through around as XXXX are MTD, initiating not hypothetical should those toxicity escalation you see for remain. potential year what the your that cohorts you go end below of

also Phase of so the to the built IGM-XXXX for given plus in dose important levels. further but the dose any is that actually parameters X in at mostly levels. at may think protocol ability to it escalation of X, define set the dose be Clearly expand of all Yes at any we the we X

that ability cleared. point the cohort at any a we So is in time have to given once do

DRX you And enrolling us help Phase X question will patients agonist? what the the this DRX study. can then of be filing in cohort might or on plans Will initiation be be commerce maybe will potentially respond for a types the IND with patients study be this enriched that to understand all program you the

about want clinical for development? you here strategy to DRX do our Dan, talk

initiate time can clinical study. IGM-XXXX DRX for something as agonist. very side some multivalent the we're our been on It's that preparing phase we've Absolutely excited to so the and imagine about quite on you program with engaging X preparing investigators

broad, tumors. for is malignancies We extends subset study particular DRX hematologic that from biology solid think don't agonist cancers. for all So and XXXX it one tumors be very into would the in to it's initial human we limited think phase solid any that X of

escalation in So those more and would the a in would other early be our discrete signals completing in initially efficacy efficacy we we selecting time the safety not potential this the want based indications, in completed after have clinic, generate understanding very at in and very, of expansions only broad molecules cancer X Once we combination commerce range a on now types hematologic add tumors. the does but data dose We very range we on preclinical not all types. that some because broad dose agonist be and essentially point from understand escalation escalation these can single and certainly would biology Phase but history in of patients. we've of to target think to also of agent malignancies DRX

Okay for very on good. congrats Well the the progress. thanks all and information

any remarks. time. the like turn to over questions I showing am to further now I'd Thank this at Schwarzer you. call for not Fred And

and Well, all forward your and look keeping call support our for thank on progress. you to you interest you for in us updated to as today's IGM thank joining we and

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

disconnect. now You may