- Earnings call transcript Q3 2022

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Operator

Thank you for standing by. Welcome to today's Third Quarter Earnings and Business Update Conference Call by Affimed N.V.

As a reminder, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. Please note this conference call is being recorded. to Alex call Relations Fudukidis, like host to at now today, for Director would hand over the your Affimed. I of Investor ahead. go Please

Alex Fudukidis

Thank us for you, you our call today. Shannon, joining thank and for all

begin, relevant release on the the we we be section Relations which press I'd everyone earlier remind Before that to of issued Investor can today, found like our website.

prepared Chief Schottelius, Chief we have Wolfgang Operating team, Smith, Chief Hoess, Officer; The the our be Officer. management remarks. Medical Officer; members including our team and Financial Harstrick, Arndt our today, available for Executive of call session Fischer, Andreas the Q&A Officer; the our our On Scientific Denise Angus Officer; Officer; Chief will Chief Adi Chief our Mueller, Business after

I'd no and the With the to to the under press identified that in Statements statements Adi. the turn to with our obligation actual those release various results date due that entitled projections you we the forward-looking Except actual statements why start, this statements with we call in results our section those today's but future identified These available materially expressed from information if and SEC. today these in limited to may remind the section to entitled issued Adi? differ risks the forward-looking as and becomes the to, by and reasons statements like and of subject and to anticipated or uncertainties, filings Forward-Looking These of I'll new over contains Risk those beliefs as under factors, events. represent are forward-looking implied differ assume SEC in materially regarding statements or those statements, the law, from call. required the not only presentation assumptions could even update update that, future. these we forward-looking in publicly Before Factors filed including,

Adi Hoess

thanks for third joining And update call. day, Good Alex. quarter the us everyone. Thanks, for

start the that update month. most earlier this me Let with important we announced

Slide available an on Artiva. showing to new cord cryopreserved AFMXX called AB-XXX November are already the collaboration X with treatment we X evaluation blood-derived of our combination NK extensive Artiva the on of on relationship after established Building As off-the-shelf cell product and take we announced with the [indiscernible]. [indiscernible] candidate

make cell For and is to this According development made analysis, us choice from partnership evolution this stage combination to patients. collaboration to combination therapy for we natural option early the program, convinced commercial the position move NK our available plus that We're of to this success. AFMXX for an this as late the a we into AFMXX. therapy fastest represents right the stage begin

access have Now gained a highly through this to collaboration, product. cell NK active we

and has and clinical development T-cell refractory or in factors clear already is the peripheral considered relapsed lymphoma is CDXXA in structure. this viable AB-XXX trials the highly response lymphoma. of we've selecting ADCC data when in generated, AB-XXX was well manufacturing CDXX-positive robust AFMXX consistent administering a activity clinical combination synergistic A clinical the study, expression. potential cell combination a AFMXX with for with the that cost is right Other shown of available and on Hodgkin as preclinical NK that AB-XXX. type product. in were the GMP-grade with monotherapy on showing experience cord AFMXX previous confident We fact Slide As and X, we're preclinical product activity AB-XXX the data as of generate and our with based patients cryopreserved future scale to product IND Overall generated anti-tumor our administered has with AFMXX blood-derived in commercialization included high off-the-shelf and demonstrate a the

us XXXX be because allogeneic study we've each been able later in to submit preclinical in for that an the allow agency product the seen initially their study pay IND that shows and with feedback will study study for trial be AB-XXX the of our little AFMXX now Artiva us XXXX. data quickly, any from This supply now our over caused FDA and to be cost. September collected that development requested of Affimed cord-blood already is XX/XX. to AB-XXX accelerate a two Phase pre-IND and they into confirmatory And and informed by progress the X% the meeting by front. will We companies. that to the leveraging we'll profile and combination XX-days, of backlog usual at Covid. that we indicated the have Affimed X agency for study quickly for generated goal making NK the in with the Moving it X% to than clinical preclinical its due clinical therapy. the also early of financial move safety on is derived combination also of the later robust clinic which by to affinity will Slide year. and data two half We the has very combination X, Still, combination Artiva provide will first that to of the good resources receiving and of shared year revenues after the has the with shared with cells. move will significant The in the terms revenues therapy has believe the to us begin deal the regulatory our the Cost collaboration quarter study of costs on of the is efforts forward a In the first the own. we're

appreciate, development at we company. are very exciting as you can the in So our point a of

we in from the with announce line top meaningful the we to AFMXX weeks, could AFMXX to catalysts patients company peripheral In in preparing provided our and addition of from the Phase updates data mid-December impact data that last X T-cell of data include have the study NK cells business the These are and serve. and redirect key combination in action. we few lymphomas a for in

you more about Now call and hand Andreas? program over recent our some of Angus. data, I'll over to clinical to the tell our

Andreas Harstrick

Adi, to the clinical you, I a also from the and side the opportunity and on that programs take our have like warm would welcome an call. on everybody my and we to Thank provide progress achieved. update

Let X. program us start Slide with on our AFMXX

known of relapsed as Our year. refractory AFMXX registration-director in monotherapy has enrollment peripheral REDIRECT earlier lymphoma, completed T-cell study also that and

is safety. are lymphoma. preliminary report of release analysis the reminder, by which is has with need. study about relapsed lymphoma assessment PTCL peripheral patients of rate the endpoint these patients as peripheral the of assessed on alone as U.S. will as well communicated, refractory to the of in limited. options T-cell of And very the the initial previously disease study data As a treatment overall from Committee, still is and more we relapsed And duration prognosis for than a be estimates, medical focus significant And an responses, the XXXX study unmet blinded data with patients poor. with and Independent a as there remain our enrolled Review In the XXX refractory mid-December. CDXX-positive primary T-cell The expect in a the response or

C plan analysis As communicated data. with also the we initiate FDA discussions previously to of following our

as in cord year. rate response over this study the second is Cancer patients rate XX.X%, Phase X/X ongoing three AFMXX evaluating for improvement ACR. Anderson at natural with an been as rate MD from To increased Slide earlier the treated the highlights Centre, collaboration XXX% complexed infusion, this at dose you CR cell dose [X:XX:X] ASH the the weight. killer AFMXX-XXX to is been our blood-derived have at patients patients abstract, with This data body XX.X% a an at agent has AFMXX XX of lymphomas. the at can July year cells of from this cells cutoff see AACR highest highlight, given increase earlier followed NK complete positive reported since with the represents that the response treatments provided AFMXX reported weeks showed that one as by NK data maintained per The On a kilogram the overall in of that XX analyzers relapsed pre date XX, single CDXX couple XX, of and We refractory abstract for ago.

Cellular As and ASH the announced Anderson Cancer Cell of in press XX. study of update our December on MD Texas trial Stem Therapy release, at Dr. Transplantation at Nieto, will an Professor Phase from Yago principal X and of investigator the ongoing provide University Centre

Now let's to turn AFMXX.

studies. the XXX are SNKXX lung patients autologous trial, with cohorts phases cohorts As respectively. we X the the to to KRAS the The expansion enroll dose cell cell two continuing non-small shows In Phase in studies, wild-type. from you in studies carcinoma, continuing product cohorts including activating with cell patients of ongoing for renal see patients AFMXX dose XX, that of continuing to combination on monotherapy mutations, three which phase we at In and studies, are the escalation EGFR recommended we colorectal escalation in monotherapy cancer the of milligrams and expansion study cancer our the atezolizumab, patients the with and combination are expansion include all are we NKGen can weekly. NK Slide the enroll enroll dose

given the phase the of of safety to primary two of quick study combination is recommended a atezolizumab dose and AFMXX, weeks. with the identify weekly dose the the As the the - testing. further dose recommended given recommended phase phase for two In the reminder, combinations escalation purpose two of the establish studies AFMXX-XXX, every at

AFMXX, which the this now the or first three their XXX-milligram XXX-milligram dose junction, tract to non-small patients Phase as period recommended has pancreatic/hepatocellular limiting cancer, cell According completed adenocarcinoma, dose patients toxicity cohort X dose escalation first the DLTs. protocol, and of are at We this milligrams three additional and cancer. to are been confirm a toxicities. XXX any enrolling enrolled without are gastric and Furthermore, weekly dose with of enrolling dose combination. for dose EGFR, at lung limiting biliary wild-type, patients completed gastroesophageal, without We we

completed is of combination vivo which colorectal investigating patients NK study, of milligrams non-small AFMXX, the have combination the Biotech. cell expanded therapy wild-type, carcinoma, NKGen and no cancer, In studies and patients cancer. The first and limiting both second a are AFMXX escalation from autologous cell with this we XXX SNKXX. activated dose treated weekly In dose given As cells at EGFR ex with lung to with cohort, toxicities. cell neck study agent the NK AFMXX-XXX AFMXX squamous these head

AFMXX. We a enrolling Immunotherapy summary are Slide we of On dose Congress at of presentations presented XX, that two patients the currently SITC were XXX-milligram are week. at showing last

This both NK leveled starting that dose data tumor AFMXX the of cell monotherapy are mechanism biopsies showed the cytotoxic significantly. of above, the periphery study, pointing a a dependent at biopsies dose the saw increased and cell adaptive We indicating and inhibitors expression T seen the way science gene manner in at provided the dose the cells of off dose and increased of T could the the of could of to activation Furthermore, that the combinations at AFMXX activates cells that doses at study be to escalation of periphery from the histochemistry saturated. occupancy we cytotoxic indicating and this occupancy the low by a the XXX-milligram innate AFMXX. also correlative immune treated activation - that activation and microenvironment action escalation receptor and CDXXA doses, blood NK me the findings with tumor, system study. increasing For function Phase peripheral patients of in into in was into when we T peripheral and combination and dose but data for demonstrate profiling, of cells brings immune insights receptor looked demonstrated portion checkpoint immune in adaptive translating the paves NK cytotoxic from also with interesting in cells. to cells the atezolizumab, simultaneous in and This innate the NK Findings lower AFMXX blood. tumor system. X

Here was in weekly. two dose first the escalation patients showed that of in we milligrams of cohort clinical XXX observed AFMXX activity

by gastric As lines with before one see had you included first line, on This followed been already patients into various treated the cancer. of the combination regimens with trial. patient in can chemotherapy slide, a and patient chemotherapy pembrolizumab three of the was

single achieved agent patient followed that Importantly, in a a to It pembrolizumab to to of response was combination had short by partial unlikely. response, so note pembrolizumab represents only PDX while very lasting where profile line, progression metastasis, the still first chemotherapy patients on rechallenge is this which very important treatment. is

regimens. after a three of AFMXX with atezolizumab different stable on showing disease The second combination patient the previous plus patient chemotherapy adenocarcinoma, exhibited progressive pancreatic on disease

patients refractory We of responses, eradicate allogeneic cells is and We ability all induced highly an leukemic vitro CDXXX-positive with lysis a against and of NK major dependent an scientific ASH against cells this by cytotoxicity for cytotoxicity AML. Slide from that are for expecting as preclinical in potential relapsed models the and and which leukemic stem and abstract showing combination cells and is the to using mediated finding, believe tumor This leukemia AML second selective potent describe announced long-term of in studies third with quarter progenitor AFMXX. we panel to conferences three or cells a will cell to stem submit cells. and combination of durable important data AFMXX AFMXX, included efficiency On associated the the remissions lines in antibody XX at XXXX. CDXXX-positive cells

aggressive refractory Given and the applications Spain trial nature quickly quickly the the way. for offer committed patients high Accordingly, and program a in need number file relapsed and as Affimed. we for of European we as for AML clinical this treatment remain the with leading disease to options of being is moved possible. the countries to France to priority able and treatment options, AFMXX And XX, viable of

the months. Additional over the please? turn next you Angus filings would are in that, quarterly different expected Angus financial call in I to update jurisdictions numbers. few on to the With

Angus Smith

income noted shown accordance the on presentation. issued the prepared the Accounting in are that and Standards International are which otherwise be Board of company's statement euros the or I'll consolidated with been XX will fall Therefore unless have and Thank statements this highlights is as Slide numbers financial Balance presentation XX sheet Andreas. and prepared you, Affimed IASB. in by in euros. in statements present currency. all functional Financial IFRS financial

€XXX.X currency anticipate €XX.X that September XX, used to $XXX.X Net mid-XXXX. XX, the ended with Based cash million XXXX. cash plan €XX.X with Total €XX million and million in for based XXXX year. million and €XXX.X into share XXXX cash December cash totaled ended million cash will equivalents infrastructure compared increased quarter activities XX, share €XX.X million XXXX September ended payment compared The the result a loss the operations the ended Net XXXX. September increase ended ended for XX, As U.S. million September hire or outstanding common XXXX costs. increased an quarter operating euro or XX% XX, insurance in we operating compared XXXX for increase equivalents million income and support costs material, by current XX, quarter XXXX. expenses quarter revenue associated common of shares our and of collaborations. income XX, ended on was XX, is quarter fluctuations was XX, costs for €XX.X and XXXX. to quarter the AFMXX for million an to to ended assumptions, quarter increase as for XXXX. with €X.X from quarter XX, trial million predominantly €XX.X the was compared relates €X.XX XX, the for personnel denominated of to common September XXXX an for to the between share dollar XX, per due million the on expense. with €XX.X the AFMXX stage million. net quarter and our quarter Net September September XX, million finance ended quarter and €X.X due payment the programs predominantly to €X.X loss €X.XX XXXX to September premiums share-based finance ended costs the in XXXX €XX.X other in of XXXX. the primarily September to related Genentech XX, increase relates the from September clinical The patient of dollars largely U.S. in gains foreign higher early September the ended of result the and quarter consulting development in Revenue XXXX. during G&A expenses exchange was expenses increase higher programs Net quarter clinical trial a for and procurement weighted the and September and for manufacturing with and Roivant associated September the million €X.X Research in from number September development the of The XX, ended XX% per and to ended expenses a in million increase increased for assets and

financial in XX, included back notes for Exchange September these regarding turn be Affimed's U.S. consolidated the the will as remarks. included closing now to in will Adi I is Commission. the information the to filings Securities Additional with of call which Adi? statements XXXX, and results

Adi Hoess

you, Angus. Thank

as Now, a validating has three-pronged seen most called very good our broad activities. is in is profile you've approach program with shown safety advanced and AFMXX and

monotherapy works expect out the patients investors. we drug take to for in value forward killer as significant as as natural planned, create could everything which with and combination cells, well as As

can opportunity will on X,XXX Considering AFMXX to now in a our NK and moving AFMXX value the company. U.S. the to commercial Hodgkin shown the on of Japan even indeed needs just Japan combinations, EU far initially lines. about with believe when to payer X,XXX and only and earlier the based lymphoma. current more cell in can you expand And XX, data again the and and can feedback, cell for patients with by patients of the refractory address beyond in be we Slide in developed As NK therapy more so again monotherapy peripheral and it relapsed we U.S. about patients address T-cell we only get Europe, major lightly and CDXX-positive the we

the partnership major Now substantial achieved that Artiva, with us to enables pursue opportunities. this through a milestone market we've

in indeed patients three If is at tumor of looks AFMXX us major parallel have the multiple dose studies. now treat you allows which favorable, addressing solid AFMXX indications. heard forward is all Important combination three to and in the in across quite safety monotherapy moving studies, overall XXX-milligram all

data additional combination on throughout XX, is AFMXX major first with atezo conference. are to highly and at of track we as XXXX at presented provide The medical updates shown encouraging in data SITC on Slide

stage X several the Roivant thank key and our AFMXX, who take can to In preclinical killing. best questions. all X of preclinical milestones families forward. do Our near over Phase to as for supporting them enter pipeline and filing we they engaging a for that preclinical represent clinical and things our in efforts AFMXX eligible programs outside for the for the continued is ready In Europe have it Operator? U.S. as further poster at on handed the achievements. your case are in in are ongoing continuing Also to the in the employees cell now in to progress support, for collaborations to term, Roivant expressing tumors milestones their various which We're development. announced the including regulatory further moving based partnerships receptor into these move patients CAR-NK forward. XXXX. a approach you that our to made to a effective through the expecting enhanced With second is Phase proceeds therefore by I'd just additional showed well early is from Genentech, response in trials like We're this, immune SITC for novel U.S. our good programs safe and tumor alpha folate which study innate and treating collaboration, presented

Operator

line Thank the Kripa Devarakonda first you. of [Operator Truist. Our comes from with Instructions] question

Your line is open. now

Srikripa Devarakonda

much cutaneous poster it's patient a so Can presentations from taking how the you missed be you Thank see And the for congratulations The to cells. it, on PD-LX PR the are the at on treated clear primary the lesions presented, you continue poster Thank cancer, And guys. impact closure in reported where you a but bit tell that me AFMXX reduction patients you Can like my questions. the little tumor City. Hi, gastric with dose. multiple you -- remind impact these sorry at in on long you. also, I a looks this to doses. expected it if lesions.

Adi Hoess

Andreas, please?

Andreas Harstrick

take this. I can Yes,

quite mainly the a primary So the was patient manifestation as wall. on gastric bulky. The seen have you tumor, which the poster had skin in patient's also which metastases, were, was

objectively regarded walls the to gastric thickening more but as an as evaluable due However, really measure lesion not difficulty real a to the lesion, reason. of was measurable

gastric vast it's the load the in bulk a a reduction wall to of which some in again, skin major difficult of tumor very saw But reduction metastases, limitation the also measure. the represented with again We this patient. that

can of patient is terms protocol continue designed that In duration as long as we treatment the clinical the treatment, benefit. of derives

be of given. there So limit that is upper no cycles possible can

Srikripa Devarakonda

Thank much. you Got it. so

Operator

you. Thank

Our of next Jefferies. question Raycroft comes line Maurice with from the

is line open. Your now

Maurice Raycroft

congrats on for the taking thanks questions. progress. And my Hi,

forward and Just PTCL. wanted on going AFMXX to the check regulatory for path

for some approval given it your So on confirmatory accelerated with of you gives about the to your other oncology approval for companies path. the relates and Can accelerated feedback plan regulatory study as space based the studies. path redirect confidence that you FDA in talk PTCL updates and

Adi Hoess

Wolfgang, take question? this can you

Wolfgang Fischer

they also right? not that data the Maurice, that know are include look consult like. have are is Yes, sure. heard will FDA do the last study. we week we the before what right? aware study will the that we path companies, will talking forward, also requesting company data, or this to FDA the currently, a registration-directed And with and And other a Yes, that the Wolfgang. Because we Hi, confirmatory Once we discussing about just is this underway. is week

and data not think with know However, go So with other we here, factors what been have we FDA. right? the discuss we considered our do

Maurice Raycroft

makes That AFMXX. sense. And one just follow-up maybe it. for Got

the Europe how United back in the development to the in do plan start to you pivot you combinations or EU, do escalation dose If our at States. eventually in looking

Adi Hoess

Andrea?

Andreas Harstrick

as announced data Yes, jurisdictions. I initial initial have think the we will we European safety data, in generate

the patient should and population algorithms is care FDA usual population the to for the standard in the Now represent and foreign that use U.S. the treatment of data requirements

by have. given selection are factors both think the of the countries that I we

France So I way. will Spain the lead mentioned and

demonstrated as well a I cohorts U.S. include embark as initial global back revert also Europe. U.S. as think should able and then be the that clinical as of have dose the the safety soon So to and program, we we cleared will development have program to into

Maurice Raycroft

Thanks taking for questions. my Okay.

Operator

you. Thank

Our next the from question comes Securities. Daina with of line SVB Graybosch

Your line is now open.

Daina Graybosch

Yes. mechanism ASM question lesions the to lesions either PD-X about EGFR manifestations cancers monotherapy combinations in it's obviously ask the targeting NK cutaneous cancer. I for, I response. of there's going the you. want that's XX any a The And clear And there's wonder Thank a cutaneous if are the regions. very gastric you're response other -- cutaneous and something that notable. of if in with of similarity or cell about

Adi Hoess

Andreas. Daina, Thanks,

Andreas Harstrick

Yes.

for I have this high skin of have patient, course, you metastases interesting mean is So have happen thank to a question. expression. the and area you skin, EGFR where as seen an you

the keratinocytes as is the we -- expression the would still cells. biologically, hike would limited normal EGFR this limited be tumor. they to not the connected their expression primary maintain cells EGFR normal think that in pattern be have that Now gastric The

there's they to home that into is tumor upregulated no So EGFR my knowledge, the skin. when indication cells on

metastases and metastasis skin data tumor of very different announced cells. a with very at the to NK consideration. not we the think or the more selecting that most we and tumor that footprint. specific analysis metastasizes likelihood for we their which of number And therefore, locations? forms for a the for histologies, show or the believe of the skin very tumor detailed basis with or cancer the I was Again, homes for may to monotherapy indications not other a cells certain combination biological to will have previously, cell a from skin bone the cancer gastric frequent of where metastatic irrespective biological biologically fingerprint PD-X of part cells conducted But maintain to gastric is liver or very different combination as So the and microenvironment go

Daina Graybosch

with the I do impact or model. follow-up. companies I indication of have the a or you cells microenvironment will let's impact mirroring see see tumor, and other vitro around in could around SAP? you in in target your any mean normal stromal potentially other any Do say, the sort that cells normal have an tumor

Andreas Harstrick

the to for think Arnd. I hand in I model, vitro could over

to would to difference I again, locations specific of NK I where other cell skin can maybe cells then not reactivity Arndt, you to tumor attaches question. NK the the locations. think and our the see microenvironment, a the between cell But the vital cell clinically, is very or take

Arndt Schottelius

Yes. got the in sales in environment. I question about you Then tumor see let talk if me if vicinity the mean I correctly. marker the

Of course, lot what NK we we know, and cells. about talk a

Of clear have quite growing data also in course, we macrophages.

for attempts, be Of recruited. evidence cells. course, they neighboring in We have terms of don't other will

see a is these Of activation we system, we mean SITC of seen, both the in also cells course, very carefully systems are have Matin the the bulk actually also to system above, Matin accessible out, way that the going pointed there. poster, talk of Andreas the of systems to the the data selected been innate is the that for indications as have NK I cells. the and get And or adaptive is natural cycle. immune think physiological we do described the Andres the which in see the immuno-oncology as

that in there as follow-ups sure your more answers question, we'll and much also. do to immune cells not happy a getting way So adaptive if I'm natural well. in be

Daina Graybosch

No, that's you. good. Thank

Operator

Thank you.

question Our Piper Kim the Do Sandler. from line next with of comes

now line Your open. is

Do Kim

poster the how at Atezo contributing more partial response the this the patient AFMXX question. change is my on had taking the think Knowing a had that I gastric monotherapy you question the do patient also in antitumor And prior, for confidence presented you thanks to pembro advancing you SITC. who cancer. does that a or In Hi, failed monotherapy think Atezo partial study? give in response that activity? you about

Adi Hoess

Andreas?

Andreas Harstrick

Yes.

question. pembrolizumab, literature atezolizumab Again, the with let's is limited. So start quite the

responses you the We data cell found Most patients literature, you any lung non-small retreatment for adverse temporarily from And PD-X, had across of that really who is is what pembrolizumab PD-X cancer. have still meaningful comes largely PD-X if because immune-related see to have in with attempts look response rechallenge. in not stop PD-LX limited these possible with carcinoma. gastric patients the of to or But experience either inhibitor, stopped or who while to events. response are a the

at receiving a also in studies, low when response are demonstrated PD-X extremely progression combination given If PD-X you The this look rechallenge was who with they of have while are chemotherapy. PD-X in rates patients many X%. especially

groups as I activity alone. that increasingly by this attribute activation also not clinical this that this adaptive And the think combination Arndt is clearly we So the PD-X. patient and also We and data think patient patient that in PD-X show and belongs have supported AFMXX to preclinical now rechallenge system. of to really to immune we do our the would said, of responded

-- forgot now repeat, I please? and long second Could have So and your answer a question. you

Do Kim

Yes.

think question this gastric change was, getting second Or was atezo does patient? how think the you response in this you response about that The in do partial monotherapy? important to

Andreas Harstrick

Arndt is drug belief we -- conference from data. will said, that the into activate data we our as Whether can year. also next a I think and recruit it as changes scientific monotherapy, potent potently can our And cells, we collecting NK initial For is the that currently AFMXX belief an macrophages. report extremely are very get-go major really mentioned,

point now response the Again, But monotherapy the with are more be data. out that overall with tumor certain support addition in to So as NK in significant we we where response AFMXX sufficient enough or PD-X inhibitor infiltration where for is are a clearly, there we activity. generating combination PD-LX cell the But believe more very could learn tumor PD-X we there inhibitor is with the combination microenvironment indications will promising. seen -- we complete that the a rate data any pembrolizumab, to have and saw studies again, combination in second increase this rate. into

with inhibitors combination promising. general in think PD-X, PD-LX and I extremely ICs look

Do Kim

That Thank very you. was helpful.

Operator

you. Thank

from comes of question Li the Watsek next with Our Cantor. line

now is line Your open.

Li Watsek

FDA potential the you're I of that potential I first, aside combo. my questions. Phase terms just can perhaps give discussions right in a taking Maybe now study? that the And parameters plus sense systemic of selection study Or you part trial size what some design AFMXX community sites for for of at trial with of of regarding as EB-XXX is X you X the thank confirmatory the Hello, therapy guess, from us mostly the you're sort a is for it combo, us. looking with from are this experience? the two the looking second guess, the of Phase centers well? having of with maybe you

Adi Hoess

this to you want question? Andreas, take

Andreas Harstrick

Yes.

the So let second me question. with start

based combination -- when our terms remarkably X academic trial experience are showed with MD to we not trial, cell these NK our profile. a So experience we sites good Phase or on with on which to anticipating have simply in trial, or sites limiting therapy that on of are our are are Anderson safety or we cell sites sites the

In fact, basis. most their of or received the their patients patient on treatment outpatient an

believe cell academic be that to that community CAR do experienced So cells that centers. a in given can therapies this treatment We not restricted well T other will other be we hospitals. also than like very think cadets

FDA in of mentioned, course, a request an of have to FDA, confirmatory be, our we will then. discuss this I also with clinical accelerated an FDA. already of we an pre-IND containing lot discussions And also accelerated will part Adi of planning a be approval as as with approval Now for these interactions IND pathway discussions of by questions. treatment, studies, option submitted terms with potential are think, followed This

Li Watsek

Okay. Thank you.

Operator

you. Thank

Fargo. from of next line Shin Wells question James Our comes the with

now open. is Your line

James Shin

taking Thanks question. guys. my morning good Hi, for

share seen you and somewhat XX AV-XXX uncertainty whether contributing matching of of as do given lack is memory-like will XX IL-XX, of you you've the be be response? phenotype the co-administered, the cells of or then secondly, risk you what think can lymphoma? in AFMXX-XXX, And the to For think may Hodgkin's

Adi Hoess

you. Thank Yes.

no what So at I'll different little NDN working to different NK are cells start solvent does. here have produced. learned in have as what -- It's terms particular, differences obviously from very we they of how intensely looked from with almost we they our the a Overall, have is types. and pre-activation a seen do can have a we way cell -- very of And in internal we have experiments, between well. Artiva

CDXX cells the one IPSCs. And studied periphery key from from important expression. are also there cold-blood you that the right it was have is we was truly that denominator So

T-cells So as level express well CDXX, extremely synergize long with as when engagers. our a these good level manufactured or cells of a Intel significant

We them quantities. have high very in affinity the high to cover

As it really you you off. can't know, when this wash is established,

stable a forms it active. So become complex and these then cells

our CDXXA. learning with differentiation own a types many amongst So different been one denominator scheme expresses cell that it there little has that very

outstanding we reactivations other compared you not that to types. as activity mentioning, an did were cell see So the

Artiva gave could so to we commercialize. in important. a quickly similar IS-X confidence indeed is And and indeed what has are a we number where clinic of great that's That fairly have wanted initiates they we the choice the what And that in this our our with -- was study advanced start is us basically far partnership. options to and this with been product bringing So or that to that's to with. us product basically, partner important, that's want very induce option Artiva because manufacturing, eventually that

Now to other and Arndt what wants over the I'll to he question, add. see hand

Arndt Schottelius

So understand was. I what see if other let question the me

I think have we mouse shared maybe preclinical maybe model... James, to the most the data that relevant and referring the

Adi Hoess

pre quickly. was about complex, co-administration interrupt and To sorry. It you

Arndt Schottelius

Yes.

review referencing with very your side-by-side, model very when with again that results, we inhibition better have and the the pre-complex cells. So it cells compared the summarized the James, there was administration, very see in of we yes, Anderson with that and we ballpark, directly carpet administration, and AV-XXX in to aggregation shared done and look growth saw, core we a while mouse co-administration, court slight one slides seen growth what question, that did CDXX-positive initial back at call, -- cytotoxicity And was have we we comparable. in excellent XX, the on the we similar we as had MD we see when not the it with we a today, the tumor but seen, tumor same total

in together taken administration forward So really just addition preclinically, the very to with a difference we do what see code Adi feel with is setting? already AV-XXX not moving confident in said,

Adi Hoess

published. that monotherapy. determine when One we there are AFMXX infused additional can of the that set. receptor is It's So data two occupancy

that the body. to engagers shows can basically, -- back this the our we cell in So NK inner cells

is this cells, CD-XX. That's here, our data. co-administration the bringing a but binding NK the the not we because kind can So following patient of is detect and to published AFMXX

again, our is several epitope activity binding the why have good to very by they're So on strong gives circulating this us, confidence. And you for plus an seeing not that is reasons. we that it CD-XX, engagers One that high IgG. very are know biting impacted

is is very it's from the this cells. A can co-administration, that achieve phase we also patient-owned see So looked infused but the solid that in published AB-XXX. cells to case, binding NK again, advantages, we we on AFMXX we a binding second with why this And yet, never have NK have and in-patients of that's we we can at XX if intakes. bound believe

similar multitude generated with on So give of basically that we and co-administration have those to top, through results good activity. us pre preclinical data the confirms set in a similar of with reasonably co-administration and obviously complexing that basis a data follow of strategy data

James Shin

appreciated. for you the much Very response. detailed Thank

Operator

the Company. [Operator you. comes next Instructions] Laidlaw question with Jen Thank & of Yale line Our from

open. now is line Your

Yale Jen

with Good you the similarities FDA, for taking bridging to X anticipate going study and sort the that I you mentioned full speak a Artiva move thanks Phase morning. for do be And to of the of Do the before potential with know lot needed study could Anderson approval? between celery sales. some the you -- questions. you speak

Adi Hoess

Wolfgang?

Wolfgang Fischer

Yes.

haven't So them. the differences at how to can't we the FDA that say we before talked looks

right? Arnd believe important. preclinical and that studies So Adi that under Andreas I these a not the in vivo anticipate before, in have right? the we set between vitro, do similarity demonstrate that's cells, by All the have we and data bridging So comparability good similarity, But mean we showing to as we mentioned study.

give However, once have spoken we guidance more to we can FDA. the

Yale Jen

Maybe designed let's one. have a fulfill follow-up might study if Great. any If just Thanks. if be or Okay. in this your that to that of needed, are mind, assume you -- happens. setup on sort guys a bridging request

Wolfgang Fischer

Yes.

potential all are we Of different we look yes, solutions thinking course, interaction, right parts and preparing FDA evaluating that. And the for all in ways. about for are for these

Adi Hoess

look of and at all as you to the cells they are rituximab, X only will started with and escalation dose they first in When €X billion. also chemical billion X the now Artiva, dose adding study do

in dose So hurdles escalations context. have with nonmodified of you running this cells, less far in terms

if continue scenario that you then that our a assumption. Wolfgang just to can be running. will larger may most the initially this number you three what This number a as based the assumption see can on conducted. to patients. is have recruit taken, that's patients treat is we've you of So said, is rightly do of And experiments And the

with understanding communication. as to monotherapy is over We in have to patients just understand this AFMXX XXX -- make also treated and

good shown we profile in NK we already. very with data combination safety top, So have cells that on a a have thorough very

there we then anything obviously, react Wolfgang being So But can run should base can that phase coming is very and different is said, is believe studies recruiting -- you. lives and conducted. is through accelerated that be any to really as in the not approval an we're a in a make treatment have this that patient to Thank based prepared because that you our data the study separate there there seen to on we assumption high ASH case just start patients these chance abstract.

Yale Jen

Okay. Thank you.

Operator

Thank you.

question comes Berenberg. Zhiqiang Our next of the Shu line from with

now line is Your open.

Zhiqiang Shu

color has disease Hi, should standpoint, durable also two or stable pancreatic very on patients wonder combination like reported. I want sort good morning. why you can I atezolizomab. the engager to much. co-tumor think, biology I macrophage you from work ask situation. on in some provide Thanks disease. ask any with to NK of One, in AFMXX I'd engager about this

Adi Hoess

Andreas.

Andreas Harstrick

to is tumors immunotherapy. pancreatic right, you're most mean I treat difficult Yes. one of with probably the

the get of could should be cells cold mechanism or into AFMXX, action we be given able to able Now tumors. initial of really NK these that believe we

could a have we activate C-adaptive and tumors. We also And data in believe C-innate indicate a to chance think immune system. really our I that kickstart concerted these of action cold that increasingly, macrophages this

different of these here. No of assumptions we parts unmet on both area it's provide really activated. selected with immune significant that very need. was a system medical action cancer based the immunotherapy worked So And pancreatic of mechanism completely has an

drive think chance. could some from show patients again, of quite we And So of could have that benefit I really action give a pancreatic mechanism we wanted to unique some rationale even carcinoma some preclinical the these AFMXX. good

Zhiqiang Shu

is Great. recently remind follow-up you Thank And you just given going over debt us a other out-licensed quick last see I you. upside AFMXX output approved, can Thanks. program any that the forward? And on from ADC program. receptor your economics guess, maybe alpha guess, there? I

Angus Smith

probably could that. I on here. Angus in chime Yes.

that aware, that we to we're Roivant -- entitled for subsidiary part subsidiary of in sales. on through deal, and return miles clinical as have costs a funding you're licensed of AFMXX will net and that deal. have And royalties as responsible We be the trial

Zhiqiang Shu

you. thank Great,

Operator

you. I'm call. all no this at today's for you This Thank showing Thank your time. questions conclude does further participation.

now may You disconnect.

Affimed (AFMD) 15 Nov 222022 Q3 Earnings call transcript