Earnings call transcript Q4 2022

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Operator

Good day, ladies and gentlemen. Thank you for standing by. Welcome to today's Full Year and Fourth Quarter Earnings and Business Update Conference Call by Affimed N.V. [Operator Instructions] Please note, this conference call is being recorded.

I would now like to hand the call over to your host for today, Alex Fudukidis, Director of Investor Relations at Affimed. ahead. go Please

Alex Fudukidis

and for Olivia all joining for Thank full thank year today our XXXX us you, you update call.

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

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

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

the call Adi? turn With Adi. to over I'll that,

Adi Hoess

of year-end XXXX, reviewing our I'd you, Alex. highlights us for made we exciting the begin like during all to by everyone operational our XXXX Good and day, call. you and key progress results across for thank joining Thank which update pipeline.

presentation. the killer importantly, AFMXX generated in compelling Let's highly jump with natural results XXXX, we And in cells. of Slide to with X combination

partnership Artiva. sign with did We a

our which that as of commercially our response, an now unique the innate from immune leading The differentiating we ability always well recently unique we effect our engage macrophages. action viable killer of engagers mode innate clinical to features And the a are our and the different a programs, the has has cells. during now that immune immune ROCK of of innate action findings proven natural engagement as innate most key other innate trigger reported, NK to cell and specific advanced Now, cells adaptive and of response about generated there and data engagers. system such to other AFMXX. success cell us this feature T is to including cell co-plus cells, NKs AFMXX innate a effective cells, mode included believe NK believe we full CAR-NK. a engagers are cell approaches We versus immune this gives to derived platform cell and as From number engineered

readthrough our on cell AFMXX on work immune data feature showing system, presented innate to cell. inhibitor tumor. T now our or [indiscernible] which differentiating our we adaptive full we migration PD-LX the and cell. activation the was checkpoint AFMXX the these combinations year, through of this demonstrated further into We cells with the cells tumor engagers As molecules the last through X, allow show strengthen to response the attack tumors cytotoxic immune PD-X in of And in can monotherapy, Slide this monotherapy

underserved. This to our lesions The these skin AFMXX molecule combinations respond gut was substantial clinically benefit indeed of deliver combination disfiguring in in with to success meaningful cancer eliminated patient enables had well-established engager who potential additional remain nearly failed cell GI combination and this with inhibitor observed innate gastric safety profile most patients of to has lesions that approach our recently primary a to reduction atezolizumab, fully including tumor. the any where a study skin a previous checkpoint treatment, that

Now to let's AFMXX. jump

treat With good the and that and indeed patient AFMXX demonstrated IIb treatment only efficacy has very currently Phase difficult completion single-agent limited of in REDIRECT options, we tolerable in our REDIRECT a efficacy patients. one showed has well safe that for very study, is to particular, relapsed/refractory. population

all profile. have and across our of XXX overall AFMXX treated we saw approximately end As very and of programs patients a consistent the XXXX, safety manageable

move we the much combination though the combination. forward the efficacy with on The for natural with we the based type made much even saw pursue therapy of a larger monotherapy, stronger treatment seen efficacy this decision and cells. to address the to ability Now AFMXX us this with population killer to treatment led to of decision patient

also Treating with insights combination of including and from resources. work AFMXX approach, to NK and deliver most expected patients is a cells more can with durable well thing that lymphoma now to efficient the benefit as do as efficacy. use patients lymphoma and is analysis better for lymphoma therapy to the right our company Hodgkin CDXX-positive commercial it's It Our patients. patients this strongly more on we suggest with deliver T-cell

Now shows Slide let to priorities which our for XXXX. X jump me

with Our IND of that the partners at meaningful running. forward need. We call Anderson with therapy the development AFMXX-XXX. study to We data number of looking up program AFMXX from the and significant X We're can know clinical work getting this NK the and plan. execution medical submitting patients the is this deliver important to and year AB-XXX our combination the cells AFMXX with our MD

is hospice antibody. was you lines me comes young to included that brentuximab an sent give XX-year-old chemo, woman vedotin and anti-PD-X an therapy mind that X Let patient who a just example. always to being after my of A combination

cell we we come day. with importantly, why clinical is as every patient had work as MDN results the with believe patient type meet cell very critical cell the that will requirements. solve Artiva complete similar allow to a features combination. NK for those of this is We Now and outcome the commercial key the AFMXX response This

share the looks or far combination you data has clinical encouraging, trial the year. to prior particularly Today, given cells. refractory quite in relapsed expects so AV-XXX that on can rituximab several we are later update with the from Artiva Artiva an study seen that this CAR-T to provide patients

data inform to future on generating decisions We're on path. Moving that critical development AFMXX. the will

year, X we allow on enabling As discuss, will the to promising this Andreas and studies us activity, seeing further thereby decision will have to data focus most from analyze all where where our this we are expect investments. to

are asset underway multiple Key is and clinical in third [indiscernible], in initiated trial AFMXX. Our enrollment monotherapy approved at the sites lead for with development our site Spain. activities X in Europe

safety cytotoxic advance the is Our understand as to confirm believe begin the Once Phase NK an into we profile, study this profile potential and with a supports monotherapy the I study to therapy. we to a compelling activity. as differentiated the intend combination swiftly cell understand goal in we approach science

over our will clinical me let Now with provide the Andreas? that, call additional pipeline. on to who insights Andreas, turn

Andreas Harstrick

to you making. welcome we to Yes. now X and everybody programs of our pleasure and the overview on It's an are a Adi warm clinical Thank give the my phone. you, progress

program. we making are on AFMXX. to progress X, And AFMXX that can you see turn our Slide in Let's

dose, at on response response refractory CDXX-positive Slide rate relapsed XX% and complete subgroup, investigators at high were study ASH cord rate with in was As was data response of as of MD In with Important, patients patients NK XX we we saw an that and of we treated and December collaboration the the the XXXX, Phase the overall lymphoma at complete treated, are patients overall XX lymphomas. these patients. dose Hodgkin show AFMXX in activity rate Phase also response treated with In a XX%. complete II from patients rate recommended with of response overall in Anderson, II rate response cells were XX% were X and non-Hodgkin the that XX% very antitumor XX XX%. lymphoma Phase the of a In recommended reported a a of encouraging that conducting out rate this XX, was the we XX%. combined I/II blood-derived are

lymphoma approaches patients this and cell finding important patients cohort this immediately that responded cells. had with a CAR-T response. cohort was X X Hodgkin had complete In relapsed with in either or patients, CAR-T been Another all achieved also targeting not previously CDXX treated after of

by encouraged durability responses so also the observed We far. the of are

expect to towards We, Specifically, XX% study of months analysis for XX X additional who and at from data at colleagues of data had follow-up together II scientific the at Phase the our dose conference the at response remained the months. patients Anderson complete X a MD treated with from least in of end the recommended provide the year.

to study prior that into was in a The line things think X. median very patients patient of I population. pretreated perspective. prior the also important study it received put enrollment therapies This was is into to heavily done

chemotherapy, lymphoma with patients been patients vedotin Hodgkin In pretreated had addition all all to rituximab received had also PD-X-containing and regimens.

transplant. expected In graft no later of or of encountered. patient that national expected therapy, characteristics. Important from AFMXX this note, other patients to and available syndrome had A summary, with limited with Important the population more received individual host shown in combination previous rate were treatment very important zero. no the from release in line high extensive the treatment have effector the versus Probably patients treated response had patients' effective neurotoxicity cells specific who disease cell-associated immune data of XX%, a mylosuppression the no proportion you achieve a none highly population, a even options. study effects The their demonstrated the recent was this is results well stem patient to could the chemotherapy. observed, that were side patients, tolerated of tolerated most also well for beyond than and cytokine that indicating also cell of pretreatment minimal that previously in killer with the treatment the lymphodepleting that no of instances study note is to response

This development trying more even need. next more in makes us important step which the is in the the patients bring therapy combination for to to

with next will NK mentioned, product, to Adi our now AFMXX already Artiva's Artiva. study, cell step with AB-XXX. this In collaboration we combine trial is As in has initiate the AFMXX-XXX

submit we the later the here, study. the reported, previously that initiate year. we we will of clinical working our this with of and design in the year. first closely this reiterate pre-IND study guidance have in can As of the in process FDA on course IND the half an And been

manufacturing trials GMP-grade cord is offers This CDXXA development. and know, clinical an you is in of already right clinical the and produced Hodgkin's is at cell goods blood-derived AB-XXX a treat The a new patients high with AFMXX off-the-shelf it structures. allogeneic, is to scale relapsed cryopreserved co-administered with viable consistent and refractory for lymphoma. of site larger cost future NK and As product with designed product a expression, ABXXX therapy commercialization combination

relapsed/refractory The in cohort planned study to evaluate separate CDXX-positive a combination have non-Hodgkin the lymphomas. also exploratory will

to switch trial. Let's REDIRECT monotherapy the study, AFMXX our

As T-cell during top ASH, we we AACR lymphomas oral from detailed patients single present that is pretreated at as active we in our showing in tolerated. will last well with XXXX. already data agent study peripheral presented data an event presentation announced At line AFMXX week, and is a this company

Now information this study community. we more look with forward the from scientific to share

move Let's AFMXX. to now

to solid see data XXXX. at all AFMXX third on Important to in you or Slide tumor studies made As with our scientific we ICE we report candidate. second the from will have progress X of conferences note, XX, quarter expect

AFMXX with present For non-small of to expects cell the anti-PD-LX cancer with AFMXX-XXX, atezolizumab company autologous cells. from cohort. monotherapy NK and study, Phase the data XX the study checkpoint from from In combination and the study approximately the the inhibitor patients colorectal lung I/IIa cancer AFMXX the combination

expects company Phase expansion trial, dose recommended weekly. dose escalation II AFMXX to data the patients The the the milligrams studies. the phase of we enroll XXX of report from at monotherapy in both are In phases to continuing

cell cancers [indiscernible]. renal know, who these colorectal you cancer cell are include expansion with EGFR and cohorts non-small carcinoma mutant lung patients As

immune in that is data science the qualitive adaptive at We the the demonstrate year in believe SITC system in observing in effectively of adaptive pointing system also activates periphery addition and as the tumor. finding of the cytotoxic New system this innate cells macrophages. we NK are and in and that we published last to T engagement activation a periphery activation of new tumor immune AFMXX cells biopsies, the and the the to triggers immune significant

has finding and above patients cells this AFMXX-treated We are cytotoxic increasing. doses mechanism that strongly of the as of XXX activation strong NK of innate of that cytotoxic immune biopsies for are our combination T AFMXX-XXX. action an system evidence NK cross of T this increased function indicating checkpoint believe in cells both believe who engagers. and inhibitors cells milligrams adaptive provides of doing received the data with the with We cells we cell additional and supports cell

On last we initial year. study shown from SITC as XX, at have data that's presented Slide the the

Here, showed prior pretreated with that metastases which a including already first has responded been the had pembrolizumab of chemotherapies noticeable followed being of various we chemotherapy show gastric study. treatment lines. by patients not X with cancer included of combination the lines to This response, reductions partial patient and the skin line, before any in

still treatment previous was patient in it while important of combination note a PD-X. to this And followed a chemotherapy PD-X had a which by whom response PD-X unlikely. of challenge with response we that is progression It's very to receiving the thus, a represents and patient short-lasting

a in after meaningful, pancreatic of into on different study. exhibited being showing AFMXX-XXX The stable progression second patient X the with patient adenocarcinoma on study, enrolled regimens with AFMXX prior atezolizumab combination clinically of chemotherapy the the disease

XX AFMXX dose cell In with AFMXX the with the patients. from additional of lung this NK the neck currently weekly ex SNKXX, non-small patients of [indiscernible] confirming is II autologous study, combination biotech, combination cancer, activated Phase vivo X given expanded second on are cancer. to The and NKGen investigating cell we colorectal recommended of both milligrams and therapy

AFMXX. to tumor killing we designed initiate the to approach AML XX, myeloid antibody-dependent immunotherapeutic positive, and to syndrome. cytotoxicity, ICE bring via cellular patients AFMXX CDXXX malignancies, expression the Slide move low with Now show levels. an on of And progress CDXXX cell engages even myelodysplastic let's cells at to including

as need we this the the to and bring working for disease hard and patients quickly treatment possible. options, are aggressive option relapsed Given AML refractory treatment of viable to nature as

ADCC leukemic XXX-positive presented at showed -- not antibodies, the can including XXX urine that high potent expression. by vitro and Denmark induces high AFMXX reminder, depleted leukemic potency. has AFMXX also approvals cells demonstrates marrow is be in a low models. AML poster AML in was tumor NK MDS vivo the samples stem CDXX in Spain. activity most vivo AFMXX and with of mutational of expression. have contrast exhibited and in ex monocline affected in As antitumor meantime, In European that by cell-mediated cells activity efficiently Belgium, patients' status lysis affected or recent importantly, also ASH to bone not both countries, of unaffected received activity France, application And cells. And and XXXX we was CDXXX-positive efficiency clinical trial X Fc-enhanced

Adi now. mentioned, As is study enrollment for the patient open

financial call With this, you the to over I please? update Angus turn our will quarterly on to Angus, numbers.

Angus Smith

financial have statement income sheet financial as Slides Board, presentation. statements with issued you, prepared prepared by Standard the is today, been I highlights on company's in financials the of which Balance consolidated are are otherwise the consolidated in XX euros. noted, call Affimed's Andreas. that presentation statements all accordance and and be Accounting functional IFRS currency. The will National IASB. XX unless and Thank Therefore, shown present will euros or in in

XXXX. December million compared ended €XX.X operating and current XXXX Total to in year anticipate December the to support €XX.X €XX.X XXXX. on year December ended ended into million cash million XXXX, on operating XX, was compared our XX, in XXXX, million cash XXXX. of million that the activities December with plan revenue our was Cash the XXXX. Based equivalents €XXX.X for will with we We XX, year used assumptions, for million €XXX.X ended XX, cash operations and €XXX.X cash for and equivalents compared

associated with by As a collaborations. expenses of million a an material increase clinical reminder, preparation early AFMXX, application, of €XX.X other programs for the associated of of with in and and result higher the revenue million trial from Research an filing Roivant manufacturing to predominantly in development relates expenses by increase and XXXX. cost the an costs in and increased and to and primarily an development was share-based IND payments. Genentech XXXX in increase increase driven €XX.X in AFMXX for the XXXX XX% The infrastructure of

million Net from a a to fluctuations the finance expenses common administrative U.S. XX% year in Net in ended and is or weighted for dollar The in shares expenses million increase number XXXX €X.XX common U.S. and share €X.X the €XX.X of assets million year. for finance during costs. and consulting €X.XX Net from denominated XXXX. as with relates €X.X The in year December million. million for predominantly per the compared increased related was December decreased exchange due share million largely loss to or to the XXXX. between and income year ended ended €XX.X in increase higher of XXX.X General loss XX, dollars share-based payment income €XX.X euro XXXX gains December foreign XXXX, XX, million outstanding an to to of XXXX. per insurance XXXX, premiums personnel and was result year for the currency the €XX for common the XX, higher

Adi review also SEC the to will now will shareholders later filed today. Adi? our call encourage which be we I the for filing the turn with closing year back XX-F to remarks. for Finally,

Adi Hoess

Thanks, Yes. Angus.

And across XXXX series As for beyond. during progress have our milestones putting I pipeline we you believe now place right in make the a projects. even are and all heard, we pieces of

Phase of AML, study Our in come. of pipeline is further enhanced AFMXX initiation through more I to the the

to We ongoing partnerships. our make progress with continue

further for preclinical In programs Genentec, over handed of the development. them case we several to have

this AFMXX first Roivant normally labs the presentation which year our meeting company, from [indiscernible] for abstract X in the ACR at been half have accepted Sciences, poster preclinic Now XXXX. a second of submitted annual [indiscernible] collaboration,

With their thank bring like Europe. passionately this, cancel your all you We're and dedicated support to I'd medications in employees U.S. the the families patients and continued life-saving for and patients. to efforts our for our for to to

We're you. now Operator? your Thank to questions. take ready

Operator

our first Instructions] of [Operator Graybosch from And Daina line Securities. coming the from question SVB

Daina Graybosch

I have a question couple data. part AFMXX on the

You say one the timing. on first --

wonder You you're you decided abstracts in which QX. and Is have haven't and or a of because to matter or conference data data you're conference it's already, that submitting still which gathering us say hand QX cancer I CRC lung the give And on to cohorts. second could of context you the expect and yet? patients type of submit to in AFMXX. also question if monotherapy the some

For EGFR presumably an for be should instance, in exposed to them lung to have all post cancer, -- also will we CRC and instance Will TKI. they to been exposed cetuximab? expect for amabantimab,

Adi Hoess

Yes. Andreas. take Thanks, hand over Daina. can to you I'll Andreas, question? the

Andreas Harstrick

Daina. sure. Yes,

first you're absolutely So the let's timing. start And with right.

We a search in of second XXXX. the couple are quarter of conferences targeting

of we submitted we abstracts even So will or those, be most for important with these data abstracts awaiting updated reported for the now some to note at the are feedback include longer than data. updated these of conference, that patients upset provide have always submitting will And time we the conferences are probably from more some will the of abstract. in

this a QX. guidance little why bit So we QX, have this explains

terms for patient XXX of in the Now study. populations, specifically

start Let's colorectal. with

drugs X in X exposed in expect colorectal lines will been various chemotherapy, mutations. will specific irinotecan all cohort, patients of lines of at to like this chemotherapy, they X For the the least standard [indiscernible], that have to we majority have

EGFR-targeting drugs they medication. They can and or Erbitux also will to be additional another have exposed

cell The all have cancer our cohort, is targeting this lung that patients therapy. mutations. of activating terms EGFR exhausted here with restricted is to non-small patients requirement again, In

either be additional could sequence can as Patients top also TKI first a of osimertinib by is this osimertinib. treatment not second a followed a TKI but of therapy a an generation or requirement. chemotherapy absolute starting on So this have

have all probably the who TKI of So patients and and exhausted and population patients we TKI who mixed some options have on chemotherapy also go then have trial.

Daina Graybosch

know you do amivantamab in cohort? the exposure there's if And

Andreas Harstrick

to on that going prior but it it to not yet. would have this We permittable have It a trial. was for be not to looked specifically requirement

Operator

next from the coming from Truist. Srikripa our of Devarakonda And question line

Srikripa Devarakonda

AFMXX. on questions couple A of

to And call combo getting that? for So What think that patients? and can line IND I for you half. acceptance expect before of AFMXX, print And have then AFMXX, Based early out have a start -- partnership the start of but recent do running then easier treating terms autologous. through said in the treating when you of cells. for you see the being sites process have first IND you up future. into will in in Maybe from thought do AFMXX, with acceptance time with second wondering on help process you than you you work other? them, investor going the with you just the with file and to in going study, -- the you're arrived both on that IND it's if sort patients IND a one into you that have Can both cord-blood too half any you

Adi Hoess

with first. then XX jump Yes, can start the question. And you with let's go to answer? the XX we back ahead regulatory Andreas will

Andreas Harstrick

Yes.

Okay.

all the try For I remember to different aspects. XX,

So right? our process the different FDA extremely one AFMXX, or whether AFMXX cell are or We yes, say FDA. we relating NK IND. cells And also was an obviously, to process. open for I question we allogeneic have allogeneic because more on very sources, say with remote that IND Again, for NK can so difficult? this collaborative already autologous the collaborative study. finally autologous and less process interactions have was cannot cells, has completed NK was So with this the

completed We have the yet. not IND process

now attitude processes. discussions these the So And to constructive cases. of those the second was? part it's been in the with hard very X question have FDA and your compare But again,

Srikripa Devarakonda

AFMXX.

get how and long time of patient? do would treating to can work you running? centers for wondering to have what acceptance, was So it And the up once our you you I IND start the take just ahead

Adi Hoess

to this? you do want Andreas, continue with

Andreas Harstrick

the can protocol will, think give, I we finalized once blessing, course, by yes, we you and final we only -- So, FDA. of have if detailed the guidance

feasibility doing sites. already are studies we at looking Now

lead We have investigator. primary our identified

good field we working leaders now the setup sites the key as with to smoothen as of opinion process in can. are We

study again, final We lines protocol. given have a after have identified us But we our a time support that in be only CRO will conduct. can final

Operator

And our Jefferies. question line Maurice Raycroft coming next the of is from with

Maurice Raycroft

you design design I combo of -- are Wondering trial AFMXX the And to thoughts wants when ABXXX or going as Street the plan ask the update was in details? additional to one dose well. for the bridging your what trial on on on what FDA terms do lead-in combo? latest

Adi Hoess

Thank Maurice. Yes, you.

said we had as clarifying with interactions FDA into past, we've together in this we and So the the have been bringing basically design. study

-- So understanding and a very good have look should like. good that understanding we're obviously we how

roughly you've I third have think And part from weeks the got X to and this the X lymphodepletion. we then second over to before to AFMXX follow X with the or in after cell that said in a go past, of basically restaging and you treatment, intend the we party. break procedure then roughly doses and do weeks installment is as a weekly include AFMXX we with give of combination then start you short NK

general have in what look we is So design study to like. going already explained would general, the --

other we the IND, as So FDA, you And further this as on feedback can based helps update we on you. details. final we soon have made hope I with have the [indiscernible] the patients.

Maurice Raycroft

update. about monotherapy wanted Yes, to Yes. the AFMXX also And that's ask helpful.

update? or go quarter in quarter third the second for lung patients there no-go that be or bar decision? the XX cell made So non-small And cancer. the will in internal of CRC, decision What's a for in approximate terms success

Adi Hoess

to I'll Andreas. hand over

Andreas Harstrick

Yes.

as you data So have aspects. clinical know, always multiple

some response that have ideas want to see. we rates So we about

responses We also have some about duration the to want we of ideas see.

these these have be pattern. a not how to characteristics, parameters addition communicated pretreatment are patients always We patient a those of it as composite in and will refractory X

clearly the have once disclosed intention discussions we have go/no-go better data. make or is we think Our based as guidance And more this on these detailed are to data. maturing, decisions data will

Operator

Li line from next Cantor. our coming question And from Watsek of the

Li Watsek

the what Maybe FDA R&D just to one meeting? your if are additional that AFMXX. you go through your clarify pre-IND to filings since it had interactions have And regarding remaining you have steps on filed? Maybe with

Adi Hoess

question? want you Wolfgang, do to this take

Wolfgang Fischer

take can Thank I you. Yes, that question.

where And got got early And this So constructive FDA constructive. the and we with documents constructive year. right feedback. got pre-IND first had we to of has mentioned responses. all, are IND, We we clarifying the as questions Andres the January which feedback feedback we have been X feedback, X first and we or right, in -- working for of submit before, as the and half the very currently said, the already positive on we this in

any looking are we're So into block now submit. and we we and to preparing didn't -- see road

Li Watsek

And now Since And European clarity and on AFMXX. you on response then maybe rolling update patients. R&D maybe is make can a you how Maybe Okay. like just it for question a AML have us pretty countries been have patients. enrollment seems the ongoing? at quick [indiscernible] rate

might this year? data we that see chance any some So

Adi Hoess

Andreas?

Andreas Harstrick

Yes.

study for The said, enrollment. we CTA open we clearance. is have As

enrollment. cannot these enrollment data we so detailed the come anything about seen about we see have just not the given releases. So will have we of far. initial guidance patients. starting we what then There, say clear are course, of This we once or And

Operator

the coming from [indiscernible]. question line next our And of

Unidentified Analyst

how goal And bridging point? you Again, you what I sites I into whether know be lead just status, like study, of follow-up. would at study, the this more trials? advanced many -- that in in of to will XXX planning earlier just on example, phases what more potential terms anticipate AFMXX a study? have Or the for terms the are overall of And

Adi Hoess

do take that? to Wolfgang, want you

Wolfgang Fischer

you. that. take Thank can I Yes,

of number a So sites.

several the with working are We side.

trial. MDS the have the correctly. of do AB-XXX with And not and I head. convinced that the the good which objective This cell in AFMXX. works have our we seen are we But -- to of the number I is see trial So what very recall my well confirm is a cell on we top exact that it's XX, to is about XX

that in seen preclinical that. all have studies, demonstrating We our

confirm it's we what So at the to have the seen year. end of

Unidentified Analyst

just Okay, curious follow-up will subsequently, that options would statement Or added and is you indicate to determined has the AB-XXX? an not use terms been that in study. in that of AFMXX advance? great. in I'm or you NK Maybe have other here prepared case, be this combo

Adi Hoess

exactly. Yes,

not have it And how the we following and put the in decision going cell that's make which going So the this now announced AFMXX in next is how performing moment, we're to it, way. let's are on then all using. And we [indiscernible], we're clinic.

Operator

question next line from our Canino the Stifel. of Brad coming from And

Unidentified Analyst

[ph] Brad Bijan Canino. is This on for

us the combination parts? how should to For we be upcoming enough many for the of And in expect the studies, to data? efficacy there will AFMXX patients see determine contribution

Adi Hoess

Andreas?

Andreas Harstrick

Yes.

the safety combination said, combinations. X and in will mainly are be the recommended for these studies definition that we focus individual doses of the using we the As on

the combination we cohorts. XXX, recently study with expansion opened atezolizumab, For have

So see again, early some year patients efficacy of the will towards or the next data year. more we but end expected

here dose, focus same recommended Phase probably XXX. So for on II

Unidentified Analyst

you. clear. Got That's

then one for helpful What from study? expect And cell learn the we on the Okay. should be NK combo to presentation could AFMXX. AACR that

Adi Hoess

Again, Andreas?

Andreas Harstrick

discussing looking detail. profile, mean You study This PTCL, at at monotherapy will of we further in safety in are a monotherapy subgroups AFMXX the the data activity mainly follow-up. AFMXX providing description that of terms activity the of looking be of individual detailed in in

the for there combination very to study. specific is learn think I not much

would combination primary study intend accelerated that As approval. target the to to XXX study you lymphoma, we where population through is set an able know, generate the data of the Hodgkin's be support

so Now ASCO be will PTCL, the T-cell type. peripheral tumor at we different data on lymphoma, show that

provide cohort XXX next also Here, AFMXX us further guidance NK exploratory we have cells study on and will our which in PTCL. steps an also the with in

Unidentified Analyst

said meant AACR. you but you ASCO Andreas,

be So at the presentation AFMXX will AACR. on monotherapy

Andreas Harstrick

Yes.

of AACR, Sorry. course.

Operator

next coming H.C. [indiscernible] our line from And of Wainwright. from the question

Unidentified Analyst

program. This I is apologize another AFMXX. on question XXX the on

the the at relapsed/refractory to trying rationale you're NHL. CDXX CDXX positive, positive cohort understand which the looking Just behind exploratory

Adi Hoess

Andreas Yes, you. will you? thank

Andreas Harstrick

Yes.

-- as has basically as It for open yes, MD well parts. the study study. this Anderson CDXX-positive is So lymphomas X

So the focusing larger are our Hodgkin is we part and registration intent patients on lymphoma. where for with

I think proof concept. clear of here, data MD has the Anderson provided

us of with As activity enable we with cell replicate of the duration that elucidated, rate data Arndt a have biology type that and and the to has good a very responses. others the response AB-XXX should believe high these

the is this part So main the of study.

MD the good study. Anderson non-Hodgkin seen we in have in responses also also shown, As we have lymphoma

far. However, patients this X only is so

always peripheral patients, So T-cell also And that has the we lymphoma. lymphoma once enrolls to decision XXX seen peripheral study the in will T-cell also have rate this peripheral response T-cell to we a in further tries are how have for lymphoma patients. separate a looking data, proceed -- cohort

at limited cells that Based we benefit that seen that will believe X of an NK patients lymphoma is the on indication and combination the AFMXX. we in these have data MD also peripheral Anderson, from T-cell

Operator

I'll questions no showing turn closing to speakers at if I'm there's time. back any the additional this remarks.

Adi Hoess

multiple from feedback and with filing and going have And data we not starting AFMXX open but readouts QX year-end registration-directed the lot last of initiation into in for XX to least, much you a FDA. this year. recruitment. QX then hopefully update of milestones for Thank mentioned, the just on AFMXX And XXXX. with for study have call in. up, as Yes. a we year soon. basically based And our come This finishes in of QX we've the very listening coming particular, but is of the

we initial that but again, to abstract. hopefully updated move data we'll on And at you we reasonable also submit some forward lead keep the usual, will as So further earnings when calls. have least should some to data

that, conclude in. call you With thank listening and the for I

Operator

that our you gentlemen, does for and Ladies participation. conference today. your Thank for conclude

may now disconnect. You

Affimed (AFMD) 23 Mar 232022 Q4 Earnings call transcript