Earnings call transcript Q1 2023

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Operator

Good day, everyone and welcome to Affimed's First Quarter 2023 Earnings and Corporate Update Call. At this time, all participants are in a listen-only mode. After the presentation there will be a question-and-answer session. [Operator Instructions] As a reminder, today's conference is being recorded.

I would now like to introduce your host for today's call, Alex Fudukidis, Head of Investor Relations at Affimed. ahead. go Please

Alex Fudukidis

and for Liz all joining for Thank first thank quarter 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 two Relations relevant be releases can today website. earlier found on to we

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

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

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

Adi Hoess

pipeline. to report Alex mentioned, call continue and that highlights I'll pleased you, has I'm our progress with as the on already Alex everybody. our Thanks joining key to today. make good for reviewing very and morning across Thank start key we priorities

on extremely study our see first new this the announce of will you we are call X, clearance And of for drug the combination application AB-XXX. Slide LuminICE-XXX. As AFMXX we investigational can with to now excited FDA

a study on AFMXX us which Nieto now by achievement findings move blood-derived to colleagues of Artiva, all forward possible. treatment this for our natural that study cord I'd it thank we and at back X in in company Center to few in the killer Indeed a XXXX. this with will in cells. months worked Conference combination the Cancer MD as the Anderson Dr. This build have Phase significant promising who this Data from past the ASH is to diligently Yago enables AFMXX-XXX generated presented was with of like Affimed make therapy.

timing we're Across AFMXX development focus and committed and Operating programs. design our will Harstrick, of Officer Chief in call. our Fischer, on this therapy can. the of of we later Medical Officer will AB-XXX key our you the to therapy into rest advancing this trial The efficient Chief details Wolfgang go for of company. quick clinical our the combination the organization, this assessing a the as our as is of and fast study Andreas update execution

on has a present plan data be the ASCO tumors. targeting AFMXX believe AFMXX to our it is the we milestone. upcoming to potential transformative EGFR Second, therapy many for cohort now with June EGFR studies data we to innate the We have monotherapy expansion interim advance from and continued X. towards expressing at meeting engager novel patients clinical solid cell

The has lung has been and data data cancer presentation data publication. the about from colorectal non-small will presenting been cancer accepted include from which patients cell online from the be each cohort. poster cohort, will for cohort, which we accepted XX for Specifically,

data be the the data call cutoff financial will The the The include plan to of more to event later press. week and with host abstract as the in included held release on on later close our the will as data a strategic be NSCLC be June will provide from community this X. will XXXX Saturday, a a detail We as only AFMXX review poster Details will date. the December include published The monotherapy date. update program. abstract full the in well of virtual on text of data call in

our all means this, and address and potential positioned -- near-term. unmet improve solid of pleased cohort, a X needs With the the -- significant been quite pipeline for outcomes Phase study medical the shareholder value our that dose already now to dose in to recruiting indications. first second AFMXX programs we in cohort the Finally, drive of uniquely we study uniquely has actively which proceeding variety hematological is We're that have announce rapidly. already and quite is monotherapy patients cleared are to tumor

now has make by conditions, to our to I current operating reorganizing company efforts our a the to Wolfgang, primarily like programs. Affimed had considering market over decision clinical Before difficult call to the expenses on that our hand focus I'd control our mention to

reduced have a As the XX%. of full-time result approximately reorganization, equivalent our by we headcount

positioned continue and ensure progress AFMXX combination the months. data all XX next to are in clinical to and all now This from for studies programs, from includes that care a AFMXX development clinical we AB-XXX, We in make as mono with within escalation. three from data we AFMXX key meet data dose with will this three AML, impact to reorganization we of the our data not well to three believe three milestones programs took extra

provide in over additional me call to Wolfgang, the we're with insights Wolfgang? will turn who And the let pipeline. that, making on progress our

Wolfgang Fischer

Good Adi. everybody. you, Thank morning

on have Phase ABXXX build in data take will AFMXX-XXX IND to combination study a Artiva. clearance into December, the the from which This As at XXXX. from Adi NK reported we in the with from ASH mentioned, study study, now AFMXX X FDA the cells we

with XX Slide data treated Data response on lymphoma recommended cord rate AFMXX Phase shown we ASH dose X of in the reported showed CDXX-positive infusion lymphomas. as a patients months in at NK the and relapsed with refractory response briefly, months. the pre-treated non-Hodgkin of of lymphoma XX% Phase the at CDXX at six and remained patients least at dose. complete recommended X, the six objective rate a patients X/X from least heavily response initial cells Phase at study in positive XX% Very study XX% for X blood-derived followup from after Hodgkin combined the treated complete with

no syndrome, is had have about disease a release and of or disclosed the neurotoxicity In patients. we we medical graft community that effector from lot immune treatment know addition, physicians treating AFMXX-XXX possibility cytokine study, there interest the to the the host of cases having treatment versus was well cell-associated in conversations Since with with available we observed. of data tolerated the such

we requirements. for very with In as have you all combination believe similar cell key the on features importantly, AB-XXX the in information outlined Anderson with with Slide has combination that cell, are the AFMXX with X. past also we MD We we AFMXX ABXXX will shared of about critical it of and why clinical confident saw commercial results Artiva’s as meets NK NK the allow those

exhausted of relapsed in A with combination therapy PD-X investigate standard refractory in vedotin, new Phase X who brentuximab with including have lymphoma a AB-XXX IND checkpoint clinical patients from Hodgkin all chemotherapy, is and for inhibitor. study AFMXX the care Artiva to

complete shown including activity on the and responses As by rate, study endpoints responses. primary is the assess Slide objective the response antitumor X, of are to partial

tolerability, endpoints well assess as the of studies and combination as efficacy, to safety of immunogenicity Secondary the of response, therapy. are probability

Now we a study as run-in will introduce will begin with already of safety phase. the on called before, LuminICE-XXX. be which Slide design the study, XX, clinical The mentioned

will each. four During of we evaluate combination this doses and of AFMXX phase, AB-XXX patients cohorts six different in

will AB-XXX administered that dosing will Now evaluate cohorts. weekly. weekly dose AFMXX Cohort except combined be through same, will a let's the AFMXX exactly X of go the mg the billion Cohort followed cells dose one XXX AFMXX. weekly with by two Cohort cells X mg. X week case evaluate will of two there billion three, doses in one, in XXX of mg XXX AB-XXX with be we cells of combined the each regimen billion

same we administer XXX four cohort will AFMXX mg will cohort the that as finally, And three, except weekly. be

phase, the dose for the dosing safety these evaluate with of preliminary dosing two will follows phase, two the regimens we efficiency which regimens and selecting optimization assignment During the run-in goal design. of stage

enroll continue sites are phase The The all the located study to then XXX and expansion trial potential to States. from -- phase. in up cohorts with has XXX one the the clinical will into United our or currently both the optimization patients,

XX will patients. exploratory is you cohort with CDXX-positive see, another there As PTCL include an additional can patients, which also

lymphodepleting AB-XXX and and of dose dosing. with treatment On schedule the to is lymphodepleting that regimen. mg the meter Slide this and patients XX This safety per per meter LuminICE-XXX doses first of therapy on including per fludarabine AFMXX-XXX. XXX cell will demonstrated regimen, based own other treated the square effectiveness mg show have day studies study day per our In of XX, prior AFMXX cyclophosphamide square be we chemotherapy

of on consist AB-XXX, three As can co-administered cycles treatment. to up one AFMXX see you weekly of the by will followed and three doses of monotherapies, slide AFMXX of three weekly cycle doses treatment

to we study Looking the ahead up XXXX. Slide XX, and as outlined are get focused QX very on run-in

approval suitability in of FDA the we lymphoma. Hodgkin process, IND the accelerated study the to During requested the an feedback support from on

a with of for agency in to have recommendation advancing requirements the the in As on discussions U.S. the parallel the will study, application FDA the further Affimed registration

half the expect share we to safety to data Finally, be first XXXX. during from of run-in phase the able

We in study this of bring from questions of ASCO Artiva Artiva us you many combination attention asked note about final on planning lymphoma. presenting AB-XXX Xth. with presentation to on data a a that of your at to data is when B-cell plans share from As June AB-XXX combination have Rituximab in AB-XXX, discussion the to the about poster wanted AFMXX

for hand to Andreas updates over clinical to Andreas? I'll the discuss the our call Now, other programs.

Andreas Harstrick

the to Wolfgang, you also call. welcome thank on my from Yes, side and everyone

from we at of EGFR Let's study of initial the AFMXX on show our and Affimed monotherapy now expansion Slide XX AFMXX. innate cohorts to ASCO present cell targeting will move as engager data two

for cancer As online a from been cancer presentation non-small cell and addition, accepted we been results to colorectal have from results accepted mentioned poster have Adi, by cohort cohort present EGFR publication. the lung in interim interim the in mutant

As will aware, ASCO full you cohorts for XXth. abstracts become and both of May for available will on be our

limited we with share for can you. today, So are we what in

ASCO a on data you significantly will will the can later reported updated However, share At what cancer May date cutoff the is the abstracts December, XXXX. we non-small we for XX with cohort, date. in of data a that lung tell cutoff cell have

patients data the and cancer cell each XX from Specifically, present from colorectal of cancer non-small the we cohorts. will lung

with call review forward. a Adi also we host As our of strategy community AFMXX mentioned, are the the data financial discuss to members and to planning to going

complete Our cancer, have second AFMXX to non-small tract junction AFMXX gastroesophageal escalation study, XXX with AFMXX we separate lung continuing is confirmed as recommended dose cancers continues type, gastric, dose and portion is Phase and are safety and patients atezolizumab, weekly EGFR The wild the X with the treat of well-managed Enrollment and cohorts combination of biliary cohorts. the three expansion and the we treatment the show hepatocellular, adenocarcinoma, in a profile. in study pancreatic, mg of to ongoing the dose. cell

study shown, to half of this ongoing from data provide As XXXX. second the we plan in

from activated is autologous combination second SNKXX combination of Biotech. of NK with NKGen AFMXX vivo and investigating the ex The study product expanded cell AFMXX

both given of neck lung to the Here, squamous wild head with colorectal patients carcinoma type and agents cell EGFR and cell cancer, cancer. non-small are weekly

We trial, patients this Also escalation in XXXX. continue and the data the XXXX. expect trial within in of we second enroll have dose to half completed plan of provide to for this phase to the

we make we we Phase designed progress once dose which myeloid then dose ICE AFMXX our cohort Now that able actively bring in immunotherapeutic the approach first has are XX new myelodysplastic malignancies, to to patient complete patients. mg X currently In acute cohort been March which the toxicity. myeloid moving to weekly were allowed and limiting with of able to patients This treated without a study, with have Slide recruiting to the to include encountering mg on weekly dose since show open at first we XX XX, and positive us syndrome. we CDXXX the our in second exciting leukemia

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

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

Angus Smith

sheet XX of and Balance Andreas. income state presentation. XX and Thank highlights you, Slide on are shown the

with the which that quick company's statements noted, euros. IFRS International a in numbers Standard as been or currency. statements otherwise by consolidated Board Therefore, are presentation prepared accordance and The As on Accounting is all present unless financial consolidated IASB. will issued prepared the euros, have I this financial will Affimed in in reminder, call be functional

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

predominantly Revenue and to due in programs March expenses AFMXX with expenses and stage Roivant of costs, [ph] by Research to procurement resulting to the the €XX.X XXXX. collaborations. and material, from other primarily with XXXX in the early increased quarter the for XX.X% AFMXX, associated XXXX million increased for XX, relates clinical higher clinical trial Genentech of increased increased development same €XX.X from associated infrastructure. was period The and million costs development increase ended trial

increase March personnel expenses ended costs expenses. income and March income ended of XXXX. to administrative to in insurance XX, €X from XXXX. XX, in An ended March quarter the offset Net March costs million in quarter quarter costs ended consulting from quarter decreased March about €X.X million finance and the quarter XXXX €X.X and ended XX, the about in XX, for decline XXXX by decreased of in XX, were a the million XXXX X.X% the General legal, €X.X million in

related reminder, are a exchange the for U.S. foreign Net gains As finance the that losses dollar ended between income due as the to costs dollars currency of U.S. or in during year. result quarter denominated or and the net are a Euro largely assets million loss per The loss to with ended €X.XX of for outstanding for common XXXX XX, €X.XX net the share per million XX, March €XX ended XXX.X million. shares was XX, share common weighted XXXX. a €XX.X quarter XXXX the March compared common of March or quarter or number was fluctuations

Additional the which filings consolidated is be included to with as the of these XX, statements notes information in results regarding March financial the will XXXX, Affimed's included in SEC.

to Adi turn now back Adi? I'll call for closing the remarks.

Adi Hoess

Angus. lot, a Thanks

getting combination Now XX. moving excited a new of of on AB-XXX, making started and show from now very snapshot that forward and the of to could and behalf with patients we we're are we're Slide programs as treatment looking study benefit AFMXX our to this We updates progress. all bringing

colorectal we going on cancer are also with for you and cancer broader non-small to our the you forward. We lung also findings during our June are studies, forward plans update to planning call to on AFMXX from X the cell discuss looking which

is the our these growth of from and the employees continue their therapies patients support to together indeed families lifesaving the has the forward. in and who progress activity And as AML, also heard, about to which past, NK a in pronounced role we and you efforts we inspiration thankful redirecting through We're can that mentioned potential very pulled quite cells. move market. making of things we us a a we as and for are with to bringing are AFMXX support you've the huge excited NK as gives It has our AFMXX, believe cells play their major the have dedication in

are to and to hand questions take operator. I now ready We the back

Operator

Instructions] of [Operator question the is comes first Our your line Maurice Raycroft now line from open. Maurice with Jefferies.

Maurice Raycroft

And wondering is powering for on the on Hi, saying for the anything the thanks is the study. study? and clarify and of stage overall on assignment part for to just taking response, bar then additional my response the question rate label, that? of success designed questions. also wanted A duration is you're Presumably study open what LuminICE two there

Angus Smith

Maurice and Yes, morning. thanks good

So I'm Wolfgang. over question handing Wolfgang? this to

Wolfgang Fischer

Yes, Maurice. thanks Hi Angus.

As selected we cohorts from of number design. right, stage assignment each the see have follow XX, cohort, these safety dose on Slide and cohorts you the run-in XX patients can optimization two will per two

are So these one. futility evaluating of forward, we That's, each yes that means to separately cohorts or a to move no. number rights, whether that's

we study. in The with similar to data generated or the the response AFMXX-XXX, that XXX right? right, what bar the rates believe other the seen bar on that very question can have Based we we very have was achieve success, high we

And could repeat? question remember, not please the third I do you

Maurice Raycroft

anything for this study? powering you're on If additional saying

Wolfgang Fischer

question Andreas, take the do that you the study? regarding want to power of

Andreas Harstrick

this can can, I Yes, question. I take

As selected option second two study, slide, the Wolfgang stage of with four and has which said also consists basically from cohorts. the think expansion continue the powered it's cohorts, on initial two to the part separately depicted of I starts assignment the then and into as dose two the

and no out statistical can came between with line This have the more So the on think FDA until FDA's final two also XX level decide of cohorts to attempt different data cohort. discussions on doses that on I there is it's on our direct outcome. to different was and cohorts per the something either move comparison available data number one in the effect the patients totality we a of the those specifically optimization of of and or with

have stage arms. statistical the separate, two these arms, not are two comparison arms between two two assignment, So again, which a do

Maurice Raycroft

can or discussions to after Got timing XXXX else the, about would first half be that a sense. -- -- nature can us would say had you the or it, to on? And study? or I of if later guess you've doing study FDA has you that nature the or single And at a registration get on arm FDA the randomized tell run-in as all about opposed have spoken requirements? you with you be be anything feasibility of makes of, data

Adi Hoess

Yes. go Oh yes, Wolfgang ahead.

Wolfgang Fischer

Yes.

the designed So still arm we very that the feasible right? accelerated from intent guidance senses. still in where single And study clear, from clearly approval, is says very XXXX, FDA certain that have following for with March, also study also an draft

a FDA the separate came continue to them. asked back recommended the with FDA that discussion we feedback So we and meeting and us that in for that

they basically for to starting So further discussions. them reaching recommended study, out while the

the us specific, did regarding with FDA, specific FDA feedback not interactions or guidance concerns. the provide these regarding, their During

Maurice Raycroft

it. Got

Okay, questions. makes taking sense. Thanks my for

Operator

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

Li Watsek

Hey guys, guess you're our in I guess of for give still thank the just scenarios registration for on, taking agency, the of you you that of questions. that application, a sense follow process Maybe you're can what kind that different the understanding with us up here? but I preparing

Wolfgang Fischer

FDA mean, next we contact and guidance. our I constant steps. are give, project determine in we with Once at the timelines we will manager agreed with will further the provide

We discuss and to it also or scenarios. to believe FDA's is what premature position speculate is are different what too the that currently

Li Watsek

in And portion, just portion wrong the And the the I run-in seamless? guess long with it. then will how got need the I you portion, to guess be the follow-up? for for dose pretty proceed is or safety Okay, discuss it sitting do to before agency you optimization

Adi Hoess

want you to take that? Wolfgang,

Wolfgang Fischer

Yes, sorry, Adi.

on slide. These the as are The treated question, outlined first patients right?

for two question moving patients selecting the phase provided And Slide to full number first cohorts study. We XX. receive And after The FDA cycles. go FDA assessment. we I dose that the need forward? assessment forward the can happen it's whether also before into the first moving will to to guess commitment No, was to up have these three provided, optimization

Li Watsek

thanks. Okay,

Operator

Securities. next Srikripa Truist question of comes line from Devarakonda with Our the

Srikripa Devarakonda

to your going. cleared. much, what on with XX be confident taking you. at have you trial data IND do then, be the should see -- and else patients order you the stage see, two and guys trial Quickly, on any so going? guys that from quarter in third enrollment? saw the first be question previous we able least also my patients? enrollment getting Thank that see congrats And And needs to based to you that could will we run-in able MD you to enrollment there It's Thank half. get said not but in you partnership in is You get done about data, with Anderson, we for by how likelihood are it the enrollment could will for

Adi Hoess

Wolfgang? Again,

Wolfgang Fischer

Yes.

we question, on are preparing patient first that. first So right? track in fully QX And on XXXX, first for are patients, we

are we the we So CROs, with et are with sites, the cetera. interacting cetera, et interacting

and fine all XXXX. on for that's QX track So

to run-in, I another safety we Regarding a XXXX. provide patients sorry, Did data HX from first plan yes from it. so have So, maybe first you the the data, question? XX the in missed

Srikripa Devarakonda

by two there the I already first the Oh, mute. I sorry, enrollment should expect trial begin is by wondering data, have half, sorry, of was on we in just was time no, the if stage to you well? as

Wolfgang Fischer

I trials. will mean, we stage of start two the we will, with

as would assessment, can't have the the exactly it soon two. because basis say. And basically be be, forward. for as will will moving that's right, the soon with optimization the first start stage as have as the said before, When we that we after safety I completed So run-in phase, I as that, we finished,

Srikripa Devarakonda

helpful. that's you, Thank Okay.

Operator

Canino Stifel. comes with of the Brad next from Our line question

Bradley Canino

be at Hi. for two the interim wondering, one depending Thanks can where I'm expansion it required looking period? comment to what follow-up says pivotal will of decision the move make clinical or data. for I'm interim that here XX to you'll length data Slide portion you into the the for updates. on the cohorts select dose on

Adi Hoess

again? Wolfgang

Wolfgang Fischer

analysis will forward, Yes, move and to after treatment not the forward on so assessments. for two be made, treatment a design the based two assignment optimization, then stage made, two two after patient followed-up be after and decision cycles, dose will cycles, will so treatment cycles the the these decision move be and two interim right, the to

Bradley Canino

thinking Particularly, you included arm Okay, run much to thank understand buy-in one Thank about how of might up being then they confirmatory you. if end help partner a this your these? the us And I'm study? FDA decisions can as the along have in is with study single concurrent much continue how discussions, you you.

Wolfgang Fischer

first I'll on Adi, very going least take It's and that then very well. very partnering the second for with part. so you is and on aligned we committee well. FDA. level, our And with really are Right? team level. that's right. transferring path all We Right? Yes, in it part, we And nice a give forward. a a I discuss, interactions collaboration a the The before the Artiva, to good have So at going common aligned

Regarding will right, commitment, please? and the to Adi. study, confirmatory their I hand Adi, over

Adi Hoess

Yes, getting input this in you and a this not obviously shared and into sub-cost. the focused played we started depicting the the we're on know Artiva have IND IND contractually, fully design. in as a role major cleared details as the study yet And is has the study discussion of

studies the So we start study, contemplating. of up we steps what were confirmatory IND and on as kind to and clearance through we're next the will with now the can take move now

forward in in already least have lymphoma XX findings within that That's we that, the we here. focused we the number the plans also terms it, findings can We options but PTCL moving mentioned patient of where a have on Hodgkin based of the at past cohort cohort. initially the with obviously on our in place

Bradley Canino

Okay. you. I appreciate the comments. Thank

Operator

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

Unidentified Analyst

NK product used PD-LX? trial for, with looking being in Artiva, or this Artiva? for is that online then [ph] Raghu monotherapy in for in in future to for XXXX product we readouts data especially as from this the half in is this have for The questions first with that we for for given us disclosure looking the Artiva. particular, are are opposed the what clinical Anderson Daina. you And confidence to ASCO in data AFMXX surrounding are LuminICE-XXX second Hi, and What [indiscernible] the or MD previous combination cells give regards

Adi Hoess

the Yep. to Thanks question. over please. Andreas, hand for I'll

Andreas Harstrick

Yes, to answer relates data at so, because will it question all basically that to it's ASCO. parts difficult be published in

product, updated know, targeting also is levels cell we agent. and both rituximab, agents the for single are with so given in embargo. different malignancies, they ASCO they we're have as Artiva B-cell cells here the AB-XXX an upcoming you into couple datas ongoing combination a evaluates Again, looking are study has malignancies Artiva the, patients AB-XXX this targeting an in that they study. the the so of without cannot a of more of dose will B-cell newer at their as go As under And status all provide update with current of that on the, ASCO and details presentation, especially or

For show the EGFR we lung will non-small for agent AFMXX, again patients with single cancer, mutant AFMXX. with updated cell treated data

data cancer our publication an ASCO. that an of week. I investor account details will more also become compared online or have both share event as new until show at to But we after unfortunately for available updated that with Again, discuss will have We colorectal we the, abstracts or course, available this to said the cannot cohort. come will poster taking into strategy, have the CA the FMXX presentation, a you. will And data comprehensive then, host discussion to think later of we also

Unidentified Analyst

what after to data are updated abstracts different are that the follow data We've short up. permitted we written the companies than the something if are released heard can look from was Is Affimed? abstract. a that Just provide not in

Andreas Harstrick

Yes. Adi one. maybe I can take that

Adi Hoess

So yes, please.

Wolfgang Fischer

Thank It's at we be this since closely very, of in further updated provide you to and call host Adi Andreas provide an updates AFMXX. and June itself ASCO data poster subsequent on at we've poster a regard. who investigator for mentioned obviously is the Ultimately for Xrd the ASCO have very on looked something out the decision to poster ASCO will investor the as was at respect question. to discussion then our our unique to the at presentation

published the be into mentioned, decision with our that's was Xrd. to Thursday. And went will the cutoff So what December wait date the as until on that June abstracts kind decision, was of

Unidentified Analyst

Thank you so much.

Operator

line question Jen Yale next from of with Laidlaw. the comes Our

Yale Jen

Good morning the taking for and questions. thanks

Adi Hoess

morning. Good

Yale Jen

morning. first to have My that question at going the How mentioned data in ICML. you Good preclinical are you? Sorry. presented release that guys the press you are question is that in well? case derived from release we of do cell the should they anything comparison that show what you are cord is as anticipate blood to data, that in data My sort and,

Adi Hoess

the Andreas, please? take want do you to question

Andreas Harstrick

be When I think data, it's Arndt to relating preclinical person the probably right would to respond.

Adi Hoess

Okay.

Sorry.

Arndt Schottelius

Okay. I'll for nice take question, be your question. to happy thanks to, Very Yale. the

also not also actually have conference. we for So some will the that products, respect have of at you want to the previously frequent embargo noticed we had and as you But any can of shown data, will conferences. this given we show specifics because the some combination assume, we investor

basis the show will into we clinic. preclinical moving for the So

you expect can be I'm sure to the will that I share activity conference, shown, more So shared but understand. you'll be that there's at synergistic specifics cannot

Yale Jen

Not that. in housekeeping the And least one out Sure. product. more for Genentech being handed the be just problem you thanks that completed, time collaboration, press since a at also and indicated you release may for the question,

So modeling just revenue we from lower otherwise? as to collaboration panel at one you moment be only a the going least purpose, forward should slightly the there's assume anticipate at until

Adi Hoess

Andreas?

Andreas Harstrick

take I Yes, can that.

the handed has we completed have the Genentech we responsible you developing So on now been to over that collaboration under with and Genentech. mentioned, for the were as work behalf that been right, were targets their

front. that on news good that's So

payments over we associated basis. collaboration complete time that we've on percentage know, based the recognizing you the been revenue, completion which received upfront As of with under is

a is, can will that basis. recognized recognizing, on that revenue those under previous our upfront by now for the not are be non-cash will financial a have result our of the we've upfront we in the as that quarters certain we projects. time work is tail naturally be recognized on will But be which assume a certainly we So what statements, payments recognized of lower than the completion revenue, in way the of payments There we've as you bulk received. disclosed small that the from

would expect the to eventually next months. hold work an we easy true look the The months way collaboration. liabilities have have, the what will received as over we've moved for the is towards that recognize in liabilities large of the should that of the proportion give XX you same may forward tell of next and of short-term to sort the upfront recognize course for we we now be completion Roivant, what payments the under XX a portion estimate at and to have that have contract An contract of there we coming, we

Yale Jen

Okay, and a and progresses. helpful detail all That's congrats and for great. thanks very the

Operator

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

Unidentified Analyst

question. thank for Zhi. you my This Andy for taking on is Hi,

your going to please X for guidance, remind your looks it Phase cohorts, and other trial Can employee behind -- of operating two my expenses what confidence forward, were four therapy. how you're AFMXX, is provide And us you please? can doing like is restructuring Regarding chosen? doses your XX% the Thank of does for two you affect that doses question cell some doses selected if going those that NK those how regarding you. level doses how

Adi Hoess

thanks move Angus? and will Yes, to question for Angus then back asking. I second over to the Wolfgang. hand

Angus Smith

Sure.

million. range I headcount So periods and the start would be to reorganization, is then see on its this to in notice are There annualized come on reduction to that we recognize that, cool savings Obviously, year mean, next expect annualized severance will looking won't of on and €X own in impact the we year in the about I but at with begin costs do the that the vacuum, an that mean basis, immediately. obligations basis. recognized expect an

€X So roughly on annualized reorganization own the will its impact. have a million

R&D other pipeline that that in context within be will On and operating that obviously investments are expenses And spread across G&A. there early the are, then be primarily the, that stage that in will reduced.

R&D to particular both a have expect we're as see, overlapping we down. we at do period the here numbers a where over of programs. actually, We've come company So in to kind time start

You AFMXX-XXX winding down. have study the

Roivant as handed down molecules and those partners. with our over now Genentech are winding being work collaborations to the on Our mentioned

to So expenses start down reorganization the beyond go year. this through operating rest should come as we of the

Adi Hoess

now And Wolfgang. back moving to

Wolfgang Fischer

been binding question used in the AFMXX, also fact AFMXX-XXX driven to Okay, flat, higher And the also we when dose Let's for And mg X a feedback mg decided AFMXX, was CDXXA we start have also has the Phase the run-in decision by after Right? XXX trial. occupancy. dose higher to the XXX XXX of and trial, receptor right, the in FDA. which this PTCL XXX cohort. and needed for safety namely the used This additional reason of we of recommended cells, higher with mg been which sites, but a higher question, optimize doses the are NK dose, the discussion basically number has may and meaningful that be from we AFMXX selection add we providing evaluate that the dose is the therefore of and for mg.

ABXXX, and doses further data the to after this their ASCO, these ongoing from study this. data your study, which The at the two based on Andreas Phase therefore earlier. colleagues we he are Artiva. our comment we said, been be of and Does When initial And selected, have from question? cannot therefore discussion presented that on mentioned move these answer X as with that our course, embargo from will time, at initial

Unidentified Analyst

again. Yes, thank you. Congratulations

Wolfgang Fischer

Thanks.

Adi Hoess

you. Thank

Operator

question next H.C. with line Our the from of Ramakanth Swayampakula comes Wainwright.

Unidentified Analyst

H.C. you. Thank This from Wainwright. [indiscernible] is

questions So been answered. have most my of

Just terms can in Phase want we the update should of and what's X in currently to study expect understand on data AFMXX how enrolling you the XXXX? any see and is provide

Adi Hoess

want Andreas, take that do to please? you

Andreas Harstrick

Yes, the I study very running is say well. so would

I we first said, started March to in only recruit As patients.

have dose first two patients. already the which cohort, completed were We

to infusions to required receive patients these valuable. However are be limiting dose of AFMXX four toxicity

we have cohort. seen allowed the which said, us open we as So to DLTs, don't second any

say, have near the form kind from very the made and which So that's we provide guidance, I extremely in currently we initial and that are XX speed. satisfied but in enrolling detailed cohorts, Again, would patients not this release will to whether we future. at we are plans of mg, our data with something

Unidentified Analyst

Thanks. you. Thank

Operator

question next from Wells Instructions] Fargo [Operator Securities. Zhu Our comes Yanan with

Yanan Zhu

discussion. determining that discussion for think additional another you X data seems needed there on the to FDA quick thank will the be a before -- within first question is of discussion each the group wondering One Hi, cadence or Then thanks I to you do safety ones was patients for regulatory enrollment, the same mentioned have Since the is about group you. Phase the is, you the would trial? for enrolling of from cohort? X next Phase on taking the require of Yes, the patients accelerated trial. Two evaluation one questions. have do a patient path. approval

Adi Hoess

Wolfgang?

Wolfgang Fischer

Okay.

the days slide Now of that four the second number And and we XX, will start then staggering, seven and and to design. parallel. patient one we you there What and patient. the start parallel, two in in each do, the you cohort wait first at then with first first That's before start go is can question, study cohort see right? if cohort a look three we and

for is, a there seven days. there is So first the patient, staggering of

with forward. to or X can't Now second then understanding. that the we we are additional in -- mentioned because not, right say and We the right? do before, not know the discussion premature. question, and next on too FDA cannot currently data it's interaction as steps and require currently that will whether cannot I the speculate Thanks it But we on comment move do therefore, Phase determine the FDA position we not of for close

Yanan Zhu

the for Thanks answers. Understood.

Wolfgang Fischer

Sure, welcome.

Operator

call. This Thank session. you question-and-answer conference concludes today's participating. today's concludes That for

You may now disconnect.

Affimed (AFMD) 23 May 232023 Q1 Earnings call transcript