MGNX - Earnings call transcript Q2 2022

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Operator

Good afternoon.

We will begin the MacroGenics' 2022 Second Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in a listen-only mode at this moment and we will conduct a question-and-answer session at the conclusion of the call. At this point, I will turn the call over to Chris James, Vice President of Investor Relations and Corporate Communications of MacroGenics.

Chris James

Thank you, operator. to financial call and welcome second discuss and XXXX quarter operational afternoon MacroGenics’ to conference our Good results.

afternoon a For the anyone Investors release tab issued macrogenics.com. website under chance had announcement, this press to review on is who these results, the has available outlining today’s not at which our we

provision I beginning website, will forward-looking statements, be including those completed. for archived of filed may to from differ section conference with like Securities this call the the factors, materially it Private Act You as various annual, would hours call via indicated the XX future important that the listeners where results reports discussion days in approximately purposes plans, of alert Safe also listen and webcast two Litigation these after by a constitute our on may about and of prospects that our quarterly, those include will Harbor to result for expectations, forward-looking the under Factors is Risk of statements the today’s discussed Reform company’s XXXX. SEC. Actual statements current

our subsequent not views In today as should of represent as be views date. any representing addition, relied our only of and upon any statements forward-looking as

Officer elect over applicable required in turn and to to even update if extent views MacroGenics. now, While the we our call any Executive the may statements to And Koenig, point statement by so, do Dr. to except I'd President future, these the disclaim at some forward-looking Chief obligation we specifically law. change, Scott like of to

Scott Koenig

runway. review financial like who from restructuring before call This I call I the Officer, so, programs well our I’d me will Financial to cash to provide results. let do But our our everyone welcome Thank our conference today. Chief will updates turn participating afternoon, headed our as Jim and first clinical to as extend key Karrels, plans webcast you, via Chris.

Jim Karrels

This well highlighted June results the as for ended afternoon financial our quarter XXXX, progress. as XX, MacroGenics position which financial recent reported our

XX, this As revenue $XX quarter million our consisting revenue $XX.X XXXX primarily June for total quarter to million collaborative release the $X.X described total the MARGENZA XX, XXXX for ended June sales ended in million to for June afternoon, XXXX. of of quarter XXXX. June Revenue compared agreements the the included ended of from $X.X ended quarter million revenue net XX, was compared for MacroGenics' XX,

in with U.S. As a in reminder, XXXX was March MARGENZA in partner, commercial the launched EVERSANA. coordination our

These $XX.X for June were the to related XX, ended $XX.X and retifanlimab modules, was and ended discovery studies. primarily lorigerlimab, clinical for related decreased decreased model XXXX. costs partially June compared to costs were The expenses development expenses Incyte preclinical for million discontinued and decreases decrease development projects related related of increased quarter increased to and research costs costs XXXX million by offset Our the MGCXXX. manufacturing quarter to XX, increased to

the decreased costs, of consulting for expenses XX, XXXX. to a compared June as net loss decrease XX, selling was $XX.X to expenses administrative margins compared the quarter The June XX, million million as million quarter net the well was were the ended ended $XX.X $XX.X million for XXXX general, primarily XXXX for June and selling, ended quarter Our XX, to XXXX. ended for and $XX.X related loss June decreased quarter

$XX.X not XX, to $XXX.X XXXX. XXXX compared from The equivalents, as of June million $XXX.X cash December received in was did securities subsequently marketable include XXXX million balance collaboration June XXXX. XX as of cash, partners million, Our XX, and balance July

plus anticipated XXXX guidance of collaboration payments received and from marketable payments plan projected our revenues, that $XX.X partners, our runway, subsequently Scott which anticipated cash balance in securities from cash, terms other through updated metastatic will prostate anticipated XX, June in product cash our cancer, XXXX. as the in of announced castration as corporate Scott. savings our now was resistant into to cash back and Finally, as Phase studies. study should momentarily well runway we I'll million This from cash extend restructuring walk expenditures ongoing today And reflects equivalents, partners, MacroGenics MGCXXX X/X to planned anticipate now related X call runway Phase the turn

Scott Koenig

to Jim. made with quarter investigational in regard Thank progress We multiple the second you, molecules. important

you several our pipeline, Listeners Before to quarters, today. walked MacroGenics are we discontinued progress spending. of our over that the our the recall prioritized product have I update past and we on plan candidates pipeline restructuring let through on studies announcing reduce will made me we that certain

reduction workforce candidates. manufacturing to Maryland. today will immediately non-commercial Reduction implemented provide in and in completed has sites and GMP in our will lightly employee to who a helped two to reduce We down MacroGenics macrobiotics site of We closure including position are in time with additional stronger areas are Rockville, approximate satellite sites taken believe site in every MacroGenics with a have wound and initiated we runway smaller workforce should to programs. financial cost and execute resources data closed. saving advance existing prioritized company. are of value grateful resources. time California-based to an our additional we our employees scale on of delivering today decisive goal The cash extend creating close innovative measures have two XX% be workforce The and not over measures pipeline measures a actions put facilities, our decision Brisbane, and projects full these advance our The and include a of research certain our was some product announced at announced our cost anticipated saving

studies. as MGCXXX in updated as Data Phase of X of With the And preclinical ongoing cash data by we well end patients our cancer the of execution should of believe dose from interim of AML study from expansion data dose runway escalation other our Phase XXXX. these prostate lorigerlimab enable X the the XXXX. actions, delivery portion early from of the clinical by and the MGDXXX

Phase terms MGDXXX, targeting of update, a advanced In dose pipeline, of CTLA-X we July, first malignancies. PD-X study next generation in last tumors. and molecule enrollment patients our molecule CD-XXX dosed Phase X/X in the the expansion study X with completed CD-X patient our hemolytic DART of lorigerlimab, our positive solid the in since quarterly bispecific in Also we CD-XXXX DART

resistant or In addition, solid to MGCXXX with is drug we in MGCXXX, announce continue tumors. which directed escalation and planned dose name that advanced X/X castration antibody cancer of has a with patients Also, lorigerlimab combination TAMARACK. I'm of to Phase patients our dose in the study patients study with BX-HX prostate happy metastatic

expect to year to continue end. study the We by TAMARACK start

MGCXXX, the molecules, broad starting In to our our our immune addition the designed partners expressing continued further preclinical family MGCXXX tumor ADC our across and tumors clinical BX to member molecules cellular to on BX-HX. payload walk multiple and With expect time these portfolio to matures. antigen's the progress to to data involved that expression programs, designed deliver with in as remaining types. let our through of updates of of candidates provide clinical investigational me advantage updates DNA-alkylating BX-HX, backdrop, cytotoxic duocarmycin our this we to regulation. take and was use other

TAMARACK provided After we first operationalize design the call. progress key of continue about the during with to quarter interactions study the study. the EMA, make details FDA conference TAMARACK We the as we constructive and

experimental or the approximately of the portion will receive four X.X during in X one-to-one-to-one reminder, every weeks patients controlled a physicians of kg as antigen mgs or mg ARAT access kg XXX be target of As X to not choice abiraterone, MGCXXX Phase an such previously groups the the either receptor received randomized group. in enzalutamide, per study, agent, per are

either the will the Phase interim Phase which be performed dose, analysis or ARAT X randomize study at MGCXXX recommended agent additional the the portion we of patients of plan completion X data controlled inform to the Following to for the one-to-one group. to in and portion further receive

to continue the anticipate by study of delivery start TAMARACK data to from of the interim We study expect the end year XXXX. by end the and

on Next, update let you me lorigerlimab.

pancreatic dose study ovarian continue MGCXXX hepatocellular combination escalation Phase in advanced with of dose carcinoma, lorigerlimab We solid included patients patients in cell cancer, to X with renal tumors including cancer, the and activity by combination castration with with may enhanced an significant incremental resistant melanoma. cancer, anti-tumor from agent be on therapy data carcinoma, MGCXXX preclinical our without anti-PD-X toxicities. Based studies, prostate metastatic

X/X stable the Phase quarter, completed a monotherapy dose with During and lung study large cancer, cell non-small colorectal and enrollment microsatellite lorigerlimab as expansion melanoma, with checkpoint-naive in second we of cancer. patients mCRPC, cohorts

from update expect study to XXXX. a this data early provide by We

a internal of decision in cancer acute leukemia of LAG-X or evaluating while risk malignancies. the dosed with Phase head intermittent metastatic our the x combination X of of patients a from with activity the showed recurrent and At activity maintaining monoclonal in a dosing our discuss the the on an believe being prostate encouraging or announcing treatment malignancies, anti-tumor patients BX-HX CDXXX tumors. study in a efforts longer neoadjuvant carcinoma line a refractory patients the solid next-generation an MGDXXX enoblituzumab have bispecific presented from In FC-engineered clinical a in PD-X encouraging in indications. on with The with data clinical DART squamous in The positive retifanlimab, localized CDXXX FC our an that that June, using treatment X press of cell ongoing anti-PD-X I'll enoblituzumab monoclonal a one the created first XX% directed to X Phase review bispecific was molecule analysis DART study antibody impact in an in other with and the to discontinue to hematological we setting. syndromes. minimize provide sponsored of MGFXXX cancer. in ability molecule We carcinoma cell closure investigators trial develop investigational relapsed half-life. study CDX in is July, ongoing recently expansion or which permitting up, prostate to-date cytokine study year first to with Johns based evaluated Phase post, myelodysplastic neck. at investigator myeloid correlated component designed of of release, regimen data and of in syndrome, BX-HX the zero from for tumor-associated enoblituzumab, with patients tebotelimab, enoblituzumab peripheral rationale safety CDXXX/CDX further patients Hopkins optimization frontline antibody investigational T Next PSA of platform programs, the including our clones. neck. of of or enoblituzumab any our to issued evaluation incorporates published release don't of patient cell patient and decision cytolytic squamous ASCO with our other positive benefit head hematologic We advance activity has enoblituzumab and poster

rights. provide collaboration product partners of will an watching I certain update our our Next, by developed for economic being retain candidates

in net BLA ADAMX, its FDA the in Phase at complete overexpressed antibodies for XX/XX as three in Corporation. XXXX, sales In the continue advanced studies. diabetes. Provention or collaboration, with end. eligible that part indicated, for Provention is multiple review in MacroGenics cell treatment targets the under teplizumab XXth, which retifanlimab, initial year IMGCXXX, plan is IMDCXXX in to approved, combination our and agreement. our anticipated teplizumab being of to In agreement ADC being leading as $XX Under teplizumab June On is if development with dose X -- clinical announced asset a from surface is milestone MacroGenics multiple on be co-development Incyte payments solid currently investigational milestone an tumor exclusively second that for agents in from we with we ImmunoGen period July year MacroGenics. types of another anti-CDX Our XXXX. an Bio licensed months extended collaboration X in purchase to as developing studied a has to is monoclonal escalation its receive several of other payments. agreement the addition across million solid by under royalties protein acquired is study believe for will before tumors XXXX a monotherapy us conclusion, evaluating data Incyte Provention received type retifanlimab ImmunoGen. important

delivering year, open to we studies call initiated medicines of now end. life a happy TAMARACK, start cancer the We operator. the changing half would in mCRPC to committed of first two remain study for year to During expect questions MGCXXX by and and we patients. be developing the clinical to We registration-directed

Operator

Miller [Operator go first Jon ahead. Instructions] Evercore. comes from Please question Our from

Jon Miller

there biting precisely and new Thanks little the being though, guys. sense get you like exact what languages So, for seems so year the it and TAMARACK data restructuring having different a Hi, the used provide runway extending mentioned the the asking two is, little I'd question it the can end because XXXX much was runway further. in [indiscernible]? on release. love bit a press bullet to of guidance congrats and in exactly is mentioned XXXX, Scott were guidance just then where through I me was the think also, you But with a expected?

Jim Karrels

I I'll Scott think will probably Yes, thanks start and Jon. finish.

that but that pushes subsequently the we cash million of the So, not $XXX which other and revenues XX, payments million is our product only runway exact month received into from guidance reflects that plus June July, we in had at $XX.X the XXXX. the additional partners runway, our cash anticipated

Scott Koenig

and the But of first Yes, able get we'll can that have John the readout given the study year. year all, just, of confident patients to we right by this the the that the and quickly start more get we where are end XXXX during and when process, the on study now, enrolled. starts, end before are obviously, precision in how of we enrolled getting be the

could that precision extend addition think XXXX now, to ongoing, amount BD have further because should precision in we we the considerable without in which to regard further, activity runway goes. obviously future far of to provide exact right we how payments, able be that to never obviously, can So, we with guarantee, which milestone

Jon Miller

a more, for same, looking forward before. enobli much. justify similar to made later XXX signals of keeping them relapsed exactly differentiated little ongoing now data or bit But studies they versus point if think expect it we versus especially XXX then active one I'd And be two to thing -- flotetuzumab, I the little programs, maybe these how a subpopulations, overlap, about both you for me tell related. patients of of about and had having light are we Thanks. the may. curious of sense obviously, feeling same sorts stage maybe to both advances prioritization dynamics of very bit you're love I'm XXX at of to look trials. the having separate about -- but so both as sort And refractory Thanks That in should and have as one we I to these enough we in Should terms not patients? early as from for sort there. this

Scott Koenig

Great questions.

ASCO enthusiastic are was either know Johns of are very to excellent. for group look or very you stopping early to lot the both excited for that set little feedback enoblituzumab the prostate enoblituzumab. fact able a profile update conducted that received were head you and despite data settings an for in conducted regard the fairly So, with expanded study, early that study which there cancer and patient's the it to we of group neoadjuvant the about very biomarker and early was on data, the setting setback in not responses, positive that a the the the Hopkins enoblituzumab, neoadjuvant the group and based prostate efforts is at as provide neck the then being encouraging And is as setting, the setting, is safety know, very at

as As with current have opportunities for still regard as enoblituzumab well a we're right to localized indication. metastatic treating given that agents on better is line. experienced need in taxane with you ARAT so our had think the efforts very to disease, pursuing set that with that know patients patients move drug the setting MGCXXX for been we But up we both up and agents is to clean later again now focused line

based that stage you of as are ongoing with different and of can of in the guide early cancer results also solid course, combination indicate indications tumor studies, have seven possibilities forward we of going looking in should of beyond that I And prostate Now, the enoblituzumab at lorigerlimab other studies MGCXXX know, tumor other MGCXXX. we those us and on types.

the of MGDXXX to are CDXXX question the and as in outlined it's use to regard that the as last to broadly with better opportunity quite to a MGDXXX had where well using as encouraged the escalation dosing studies patients the also late including using initially MGDXXX, we with the we've ash that syndrome reducing tumor based application both early do In we with particular, encouraged looking disease, over Now the use as AML about other in is MGDXXX look and combination broader very beyond expressed, line we much the and after we disease. refractory disease. you as on were beyond had refractory therapies meeting, and patients flotetuzumab, do settings, indication. model refractory flotetuzumab, with patients, are of cytokine is well intermittent allow with able studies relapsed in by dysplastic both we will release, profiled extremely We're what standard MGDXXX and respect at dose other in this with of

So, certainly for differentiation there them the our some use refractory why we rationale MGDXXX of of a expansion intended provided of development. and stopped further pursuing the mass is

Operator

question next from from comes SMBC. David Our Dai

David Dai

for Hey Thanks taking great. questions. my

a as have of well. questions couple I So,

So, first around question just is MGCXXX.

So, XX% we mCRPC XX% ESMO of that X those and look expansion the reduced that Phase was the dose when patients at interrupted. of we study patients last dose about were year, were saw at presented

dose the we patients? duration these think interruption -- trial to TAMARACK TAMARACK level the provide So, long potential trial? through could of that should Phase on was the the reduced read how some about you reduced? for then the for dose dose color the And was X/X And what lowest dose how regimen were

Scott Koenig

we of and that drug well out delivered treatment amount came side as particular or with that was were very Grade highlighted average of ultimately doing who dosing a to largely time with Ones during course profiles. pain caused mg where patients. patients effect restarting Grade of the patients to manifested only were side before it with of but patients not of tested very been we patients. dose expansion dose indication. the patients for thank from other reductions studies with side by before analyzing by effect as turns seemed and And a We responsiveness. responses, stopped Grade the solid profiles, tumor cancer, was majority And, was those the or we at out ultimate that with three-week therapy, for a effects turned treated holding was the set patient with doses that majority sized Again, we refresh that have patients you effect dosing, in that prostate many clinical patients out full It with question. level. into from the periods problematic just the to X in much started we of per results we've in terms to the study data those were most continued the everyone's which patients, treated their memory, of that appearance looked those Xs, data this XS, X, side the both Grade in kg the of that cohorts highlighting up MGCXXX syndrome, number identified lot significant all to X extracted this, had longer hand-foot spent David, only every while of had either due those profiles, few had treatment. of We obviously, the took patients account, out continuing

inducing effects, mgs And basis. the that effective an in up the analysis so we as basis, both these weekly a well reducing to saw incidence was that a a severity X that of when side and did we kg QX that ultimately of per range on actual treating dose as difference responsiveness, per on fell decided weekly mgs X.X kg in patients, QX we

boxed now study. the in in that components to we've dosing X/X of this range -- move So, Phase X ultimately forward Phase

Operator

from from Stephen Stifel. Willey Our next comes question

Stephen Willey

Is you TAMARACK? for just Yes, during administering? Maybe just it there you're regimen? dosing could how And a migrate questions. cycle over the speak be taking just guess, good drug well, then anything you're going can Thanks is flat that a to to using quick be had Is XXX, attempt titration as to kind dose that some that'd you're one? about, with follow-up afternoon. respect I that of this if helpful. say you pre-medication on there And to some the then

Scott Koenig

FDA, escalation interactions dosing, getting a lot going this flat ultimately out first either ultimately on increase, based of Yes. on MABEL time And in a can dose We we weight Steve, with with flotetuzumab a be body a or based particularly with drug requirement. started know, on weight, you dosing this as spent that on regimen this week. believe a the the and the dosing forward. was we on the flotetuzumab of or

So, But as to lower how quite see to a line. have those we expect have the quickly, move particularly, we'll see doses, up but to we it's if goes. that we'll move up

Stephen Willey

XXX guess, Okay, you to the Is of the helpful? enroll is should patients say data be of presentation these I speak then, on going if based -- for events, be TAMARACK, the to efficacy hoping threshold sites the side? what And with that and progression that guess, anything data, analysis can the that number expect you're that there's, I radiographic across? that it some number can upon just efficacy interim guess you would of trigger I to just of to be that to interim the respect

Scott Koenig

final We're obviously sites, given So haven't come with in regulatory we of to a timing number. regard sites. the of US things with up starting number

as plan a and in this Our is study worldwide to US, Asia. Europe have

the double of of move initially would as expand from come up the be get X liberty will that With the expansion, analysis when going specific Again, site that that the with the for European response which I little to Phase right specific the will DSMB. – obviously, to the forward. expand rates We we'll the precision also analysis, amend in at being now our any we include, X – we hope groups of And So of with. the not obviously by feedback ability we're in digit that at disclose course number Obviously, during the from we engagement had year, particular is time to plan study. those predefined to X. and time study, then groups bit in those defined end do to regard data we sites. a have, large that Phase over ultimately a protocol given the on will three we'll plans a course at – up have the during two we will it futility X able to enroll be be control the Phase to experimental analysis to this incorporated especially is we patients as that can't is number what group. we a There to start intent more of and enrollment. Again, Phase end give the be the enrollment one XXX

Stephen Willey

for questions. the Thanks taking Okay.

Scott Koenig

Steve. Thanks,

Operator

from Darout Markets. Etzer Capital from comes question BMO next Our

Etzer Darout

question. taking Thanks the Great. for

on again Just MGCXXX.

we'll compare Phase we benchmarks should can, to analysis? we about speak if perhaps to population could in Should patients a wondered at prostate about cohort? the look again, now castration-resistant then that it for Just any you terms at study that of bit kind in And metastatic cancer you if about of how speak interim responses you the that similar at of what the in to to think looked little appropriate maybe you'll see think X/X?

Scott Koenig

for sets with TAMARACK. or question of regards to thanks much so questions So, that

the cohort to similar metastatic the of to disease, prior They prostate will on will you're three patients regimen, in I cabazitaxel therapy. And be a expansion in -- had of to have of up on patients therapy. we castration-resistant whether well will on targeting think response we have they've months they benchmarks differ depending very the responses one four I in of XX lines mean, enrolled patients. months rates also but depending regional that, Again, be range based the of that can prior androgen-receptor has up analysis also had to cabazitaxel agent. that what very prior had again, no The optional the lines So other on stratified baseline aware prior previous regimen. to baseline overall two the drug. will obviously, allow docetaxel one and visceral chemotherapy. These of And wide

So obviously, the agents market, group. for reason of these patients a are control introduction have that new metastatic and now included and landscape we what the obviously, of changing receiving into

very benchmarking So able to to of be patients. do job current status we'd a of good the

Operator

Our [ph] next FactSet. question Kim comes from Masaga from

line open. ahead. go Please Your is

Scott Koenig

We one. can next the skip to

Operator

Our from next question comes from SVB Jonathan Securities. Chang

Faisal Khurshid

might for combination. the MGCXXX Thanks wanted you of we then question. us I Khurshid also, MGCXXX for on plus ask for is guys. see Hi, used? is Jonathan. for This to Faisal particular, dose study Can lorigerlimab in taking remind what able when here, being be the to And design data that combination?

Scott Koenig

Thanks much. very Yeah.

lorigerlimab be QX kg both next is on side effect it's would right for mgs dose as now. targeting profiles, per based We're on think lorigerlimab to interval But at on and MGCXXX. mgs weekly per be -- expected to in combination There dose basis and MGCXXX we same forward regimen. other going dosing dosing. slowly dosing. the take we're kg we etcetera. kg, the now, The mgs dose MGCXXX can to X the be titrate modifications have And monotherapy I dose would is the the per up like starting escalate one So plan X the

Operator

Zhu Our Guggenheim. from next comes from question Charles

Unidentified Analyst

of expansion planning regarding I year, I maybe data. this you some on that to This are is having had the on think about this, old about Edward melanoma Charles. dosing some present time the regimen? for if missed later and last data you but apologies and prostate MGCXXX talked Maybe you

Scott Koenig

Yeah.

going hold of one that to the we an to the on expansion to At this question. the cohort time, melanoma. the as heard program, for you've off seen. encouraging much patients the today, despite very thanks adding were So intending melanoma additional we add cohort we at this, with prioritization regard said to we're things was for And data time, we discussed had

are we these program, updates on plans right to we've on this that to our time, on everyone our So And regarding studies going experience got with with it indications. indications. other update now when will initiate additional at depend other

prostate, the for going So the regulators feedback forward and have plan the from experts, our from the TAMARACK the we key study. regard with to

scientific now, sort at right future updates on will in this So date. some a further of publication come

Operator

from Lawson final question Barclays. comes Peter from Our

Unidentified Analyst

This Shay taking for the Peter Thanks Lawson. question. is for on

us the XXXX? XXXX we and you the about With -- be thinking for should the OpEx you help through remainder restructuring, could how of Thank

Scott Koenig

the the heard guidance say, be specific basis a is today, steady-state from providing note million $XX approximately cash not We're savings to us anticipated Shay, expenses. as with on we headcount the should runway. you've that providing, annually. regard Yeah. I'll What are

Now because through year, of approximate we're full halfway in XX% the reduction not force. savings than the -- but amount this the in of -- that's more obviously, full year from the

Unidentified Analyst

Thank you.

Operator

do have to like At to from final a Jim Masaga question remarks. for turn Koenig closing We now the call time, Dr. over FactSet. would Scott from this I

Scott Koenig

hope you, for a joining on good We of We look everyone, future. our you have programs the the Thank in near our evening. you today. progress various to call forward updating

Operator

participation. gentlemen. This concludes call. Thank you you, Thank today's ladies and for your

now disconnect. may You

MacroGenics (MGNX) 9 Aug 222022 Q2 Earnings call transcript