Celyad Oncology (CLYYF) 7 Aug 212021 Q2 Earnings call transcript

Good morning, and welcome to the Celyad Oncology First Half 2021 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. I would like to turn the conference over to Dan Ferry, Managing Director with LifeSci Advisors. Please go ahead.

Thank you all for joining us today.

Private would forward-looking remind of statements securities including I event that the begin, Act laws, contain Reform may within the we like everyone to today's applicable of Before XXXX. Litigation Securities the meaning

statement forward-looking by these risks risks description forward-looking from statements involve can from actual the this of made Securities or in may and or based, the may by These reports implied expressed to expressly those on change March company. to other any condition, or expressed unknown financial of regard company those only the filed such found reflect uncertainties, or achievements in statements. with filings differ any as of expectations required regulations. these reports, actual its date change and any speak statement by disclaims U.S. and which risks, any SEC the or Forward-looking its XX, forward-looking results XX-F statements of be materially and The the company's subsequent statements. to obligation company's company call, filings forward-looking on which such on and in and and unless on and may events, uncertainties any and update with circumstances law this conditions or performance call such known is thereto implied the A cause Form Commission Exchange XXXX, list annual results, including differ in by report materially

yours. Oncology. turn of Filippo Filippo, floor Let Petti, is the me Chief Celyad to over Officer now the call Executive

joining of and financial for update you, the first Dan, operational for XXXX. us for today our and results Thank you, thank call half everyone,

Charlie team management and Officer, our Stephen Morris; Medical the our Dr. Officer, Dr. David from Rubino. Scientific Business Chief Gilham, Dr. our Chief Officer, me Chief Joining is

of an and operational the the update, the expected call today's followed months. milestones financials the and key outline an next overview several We of will clinical company start with by over

will We questions. your line the open then for

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disease, call, R&D will live you today's While the the detail the revisit if technologies and evolution on of the urge our It event. get replay you patients. to European shRNA-based driving candidate, of on Day some Hematology June allogeneic in for in our we page listen from same CAR-T showed tolerated presentation cell in we started developing data. allogeneic CAR-T the to team our partial meeting shRNA preclinical our of data half novel This at additions showed of the that treatment clinical Data of of well deliver that our dose just Association first with replay of with from enhancements Data on important well I of response includes results encouraging how activity development. of With initial novel and available encouraging in our clinical a X programs robust IMMUNICY-X offer the and participate relapsed/refractory our to that didn't will proof-of-concept positive approach CYAD-XXX kinetic initial is Graft-versus-Host therapies a let's and CYAD-XXX X and as with CAR-T as Events call. stream achieving helped was establish levels capabilities our candidates. to on innovative presented steady first X website. for updates trial said, to towards technology the no out are to a the multiple today's In of from The continued myeloma. on allogeneic is themes more patients our you evidence the year,

some I'm the allogeneic we're say platform. of Charlie let is true the of to into to the proud a redefining will therapies our pleased results with results, real-world minute, I which While CYAD-XXX these shRNA approach especially the very broader drive And in with potential opportunity the our CAR-T offer making more potential novel great that advancements benefits. we're preliminary by discuss insight

Preclinical by to promising, complement addition, that short, to our malignancies. Again, as armored CAR-Ts, impacting our great cytokine our recently this both indications therapies date speaks potential of builds with vision the solid our ability candidate treatment armored IL-XX, for CAR-T offer especially to David are armored first for CYAD-XXX, been platform the approach. opportunity of our done we our CAR-T has we've solid is tumor and our our of CAR-Ts armored our In our opportunity will to another for tumors. work introduced we the a all-in-one as on discuss candidates differentiated the very just that the allogeneic shRNA CAR-T platform to framework the candidate drive technology and local potency one cell important tumors In for within microenvironment, engineered this vector to release of goes hematological in to beyond IL-XX believe platform, a minute. increased technology for providing

the now here, Scientific David? Chief Gilham, to turn more over provide stop detail. to our call Officer, and me Dr. I'll Let David

and Filippo, today. you, us Thank joining for you, everyone, thank again,

first of gene that As of seek CAR-T allogeneic Filippo the optimizing I with presented just the knockdown technology developments discussed, armory. combine through in the XXXX, to part cytokine our we've functionality and shRNA-targeted

clinical to we provide efforts, new CAR-T opportunity these believe candidates. our During recent next-generation our and R&D the Day, we potent increasingly highlighted developments design

include, rapidly testing clinical CAR-T first-generation peptide inhibition. our that -- therapies CAR-T testing with into product, allogeneic of clinical the through checkpoint course, combines peptide CYAD-XXX TIM heading allogeneic that sequence current with our NKGXD-based Our is

Our and second first CAR-T really which CYAD-XXX, spearheading role platform critical development. in CAR-T is allogeneic shRNA plays a is our clinical shRNA stage our allogeneic

absence level technology, symptoms further and the engraftment confidence development discuss on From touched X first high Graft-versus-Host demonstration disease a a as allogeneic of provides the concerning more encouraging. supporting perspective, the earlier, IMMUNICY-X of our Filippo Charlie platform the moment, of in cohorts development in shRNA for will is As technology. data a initial in of study the a platform clinical its

Day, technology armored allogeneic diligently on working cytokine the CYAD-XXX the receptor, first an candidates, form of coexpresses zeta CYAD-XXX. potency. shRNA-targeting announced NKGXD our recently at single we as we IL-XX R&D for active allogeneic and a are the CDX CAR-T As the

an the are to members, believe Our preclinical treatment interest our in demonstrates to models. board scientific candidate one the advisory IL-XX has are submission developing first for in of is be been what mid-XXXX. application CYAD-XXX of for end, the a publication cell studies excited IL-XX several we be for we CAR-T IND-enabling that armored IND and publications, armored grounded therapy activity cytokine cancer. of ongoing expected with key including allogeneic To this for CAR-Ts this showing in in [anti-tumor] superior

IL-XX. end, function the as to our potential over appreciate enormous Beyond Morris, this Moffitt Charlie? and platforms to optimize At to CAR-T Cancer Celyad collaboration CYAD-XXX armoring tumor with exploit R&D both cell With the with we alongside and turn we of I'll Chief we Day, portfolio. at Medical into our a shRNA that, and diversify Day, of require bringing To And validated call internal target. TAG-XX Center importance property phenotype discussed Oncology's see looking new the our diversified to further we discussed these pipeline Charlie be intellectual now the R&D that external investigate using the the Officer. targets to targets. will targets

It's have Thank call this the year. opportunity clinical speak to pipeline to on with about over we've in past everyone today's great progress you, our made the David.

our so ongoing through future have to by the programs year. the and very our Filippo decision we're have of from remainder generated our our focus for David data As prioritization we've XXXX. this we and R&D assets, discussed, We more far excited allogeneic studies support potential of the through

of start activities CYAD-XXX. for Celyad novel Graft-versus-Host signaling first-in-class update native molecule inhibitory TCR me TIM, an of edited with from co-expresses CDX the clinical by non-gene aim that the candidate on the or providing and with TCR interferes disease. the the clinical of protecting risk which our Oncology's Let receptor reducing complex zeta, NKGXD

in XX is response, X difficult overall months. for indication CYAD-XXX overall Median to metastatic GI trial, progression-free including cancer, alloSHRINK from focused date. with dose the ASCO the survival objective presented received showed the and patients on a January, escalation following response. colorectal an data stable chemotherapy. Median microsatellite was patients of the program I we clinical the of At preconditioning treatment immunotherapies objective survival X.X symposium was FOLFOX CYAD-XXX Phase months. segment XX XX.X who of survival PFS Our

or dose we generally diligently became Subsequently, will observed X we initial to is knowledge, in preconditioning at treatment investigational work a the from XX CYAD-XXX and tumor challenge patients, infusion. patients tumor cancer clinical CYAD-XXX first Graft-versus-Host showed the that the CAR-T activity criteria, in X X.X overcome. was of presented evidence space colorectal CYAD-XXX with addition, cohort, allogeneic in decrease expansion In metastatic patients late-stage of which dose-limiting well X disease. our of burden tolerated evaluating major no refractory indication, to X one the dose data toxicities FOLFIRI the following solid chemotherapy of according of a CAR-T of including per To continue RECIST billion to to evidence highest was candidate generate cells for

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FOLFOX the findings, cause the these different We as of in preconditioning of investigate development CYAD-XXX continue will mCRC findings, using of than FOLFIRI. to result further a continue rather but

well response NKGXD following which from is immune immunosuppressive to immunostimulatory, benefit patient effect tumors. convert here CAR-T then microenvironment the have anti-PD-X its with exert the the shown by refractory further will in XXXX. expect have chemotherapy the microsatellite-stable with followed Merck's KEYNOTE-BXX in disease. CAR-T to look preconditioning end Phase activity cells of KEYTRUDA trial ability may the as with enhance preclinically even tumor evaluate mismatch in microsatellite-stable to We that the for ability following provide clinical cells an patients repair-proficient in study our CYAD-XXX endogenous of we the that the treatment as mCRC concept we that an may that KEYTRUDA. environment state initiate fourth CYAD-XXX quarter will treatment release anti-PD-X year, have direct The which both believe the can FOLFOX Ib antitumor As to we the potential to the This therapy

responses let's currently to single Association June, chimeric evidence Now first following cell a patients single of CAR-T proof-of-concept complex. CAR-T allogeneic to million generally zeta tolerated of cohorts. at trial CYAD-XXX of BCMA-targeting candidate for is seeks component disease of a to enrolled of safety treatment with observed in inducing can data refractory In the evaluable Congress the X partial fludarabine, and disease. infusion of with that as knockdown detectable co-express of all we CDX a observed. with infusion the with IMMUNICY-X levels no with The dose in Virtual dose cells the to presented escalation per which development were or first-in-human the from among well patients with for patients dose a myeloma. antigen at efficacy to of X determine generate chemotherapy first-in-class being turn cell TCR shRNA-mediated the engineered Hematology observed CYAD-XXX as phase cells at interferes the patients first in Graft-versus-Host the evidence all treatment and humans is establish CYAD-XXX, well relapsed in and allogeneic receptor the study the CAR-T level patients trial Two of in further the IMMUNICY-X antitumor open-label expression the CYAD-XXX preliminary and showing dose was European dose dose trial, engraftment preconditioning X CYAD-XXX multiple escalation cyclophosphamide without recommended from which CYAD-XXX in evaluated X XXX Graft-versus-Host of a shRNA,

We at preconditioning continues show with of trial month, X, Graft-versus-Host updated no first explore level engraftment Just ongoing. higher regimens Enrollment CYAD-XXX plan dose-dependent patient last to date. in the reported in data we disease which further cohorts. to to to the is from future dose doses

Looking data ahead, to we during additional from half study expect the report the of second XXXX.

dose treatment to with target of NKGXD trial MDS X, CYCLE-X currently Preliminary CYCLE-X the for tolerated cohort date, the To efficacy safety X CYAD-XX, dose CYAD-XX shows and a data and incorporates shRNA Phase to to and MICB expresses CYAD-XX NKGXD I X, trial, the been to the dose have ligands patients received that turn One XX from is evaluated at that autologous cohort including and at leading preconditioning. of the cytokine patients in candidate let's has and was so receptor date. the Lastly, our grade technology relapsed/refractory AML escalation CAR for level level following dose-limiting in toxicity being MICA to well treatment syndrome, dose patients. generally X level X expansion release reported patients X.

reduction positive Enrollment with been cohort program year-end from MICA generation clinical production. observed, previously is our we ongoing, the expect activity autologous by from in data level and product, first the is for XXXX. initial the shRNA-mediated still NKGXD consistent dose the appears in reported addition, MICB has or In that which than contribution and additional greater which X the

that, and prioritized plan we past the with collaborative and have assess call the driving refractory allogeneic could With to there's believe unmet potentially programs MDS, in partnerships assist to let profile, AML we clinical development Filippo. autologous relapsed While this year, our for further continue the differentiated patients the over need a CYAD-XX's high we turn of to back me seeking now that candidate.

Thank you, Charlie.

financials. Oncology English. all full just details both remind Turning our that and are I'd in to to our in like on you the French available Celyad website financial

AML half to our XX.X million the X.X administrative programs. decrease General first decrease MDS autologous for of the primarily half of first the preclinical EUR million XXXX first X.X driven a million XXXX. million EUR EUR compared to Our for development were XX.X in compared the of and clinical at activities were XXXX expenses expenses and of research The for development half by and EUR the the EUR and was X.X increase share-based living with payments period insurance and the by company's in other million income An million on half for was costs to the to for compensated of million warrants in X.X EUR decrease for the XXXX. for Net travel first EUR income a associated a of first X.X half and first compared half XXXX. savings plan. other of net XXXX of related were expenses expenses expenses

was for a XX.X grants of Belgium decrease the cash amounted EUR for to expenses associated income a and the share received net cash XXXX. primarily loss first the for of of per in half for period as million per first for first to for same the XXXX compared the half from the which due Insurance. XXXX operations, The million X.XX development the Region in decrease loss share other Net of first Our EUR net in EUR EUR XXXX. XXXX. of XX.X XXXX the EUR Health was X.XX first loss research used Net and effects, Federal of noncash XX.X XX.X EUR half half from in -- million of compared excludes to with Institute half net Walloon the to was million or or

of As treasury had million. or of June $XX.X XX, company a approximately XX EUR XXXX, the position million

sufficient the that Based scope the we we our estimate Shares against towards is innovative equity cancer. raised of In end quarter into our fund ADSs. half the of focused than Celyad Park current should in cash EUR mission developing of million the with of the first with American operations capital our of Capital third and or or XXXX. and purchase During closing, remaining sale XXXX, cell more combined to $X.X ever Depository expenses approximately and X.X activities, of expenditure Oncology equivalents, established on proceeds agreement therapies from million Lincoln be cash to requirements access

of We with metastatic evaluate cancer with expect in CAR-T our patients initiation quarter milestones to half trial will colorectal early including KEYNOTE-BXX of that in KEYTRUDA several allogeneic key we disease. study microsatellite-stable CYAD-XXX Phase announce advanced have second XXXX. of the I The the candidate, XXXX, the in fourth

of additional myeloid IMMUNICY-X Phase In for to data into for for CYAD-XX myeloma, by operator year addition, turn from an in the XXXX trial over to next additional armored as And the we data the of relapsed/refractory relapsed/refractory mid I to of look lastly, XXXX. the plan now Operator? I And for year-end myelodysplastic we syndromes leukemia trial treatment we next plan for report for CYCLE-X recently of questions. year, I'll application year-end submit with IL-XX announced CYAD-XXX, acute program, CYAD-XXX by that, Phase for the call -- tumors. IND our from treatment multiple CAR-T the solid

first The Instructions] question comes Bryan with Smolentseva [Operator Olga Garnier. from

Firstly, the XXX, data BCMA some And the we protein could if form you you tumor maybe levels? binding could biomarker there expect IL-XX? any considered for look to on question at if microenvironment. next curious QX. second decoy-resistant I'm remind are us on you update have to the IL-XX clinical And using planning additional And with see of levels are if within data?

the Thank then questions to protein. in you Charlie XXX, perhaps on I'll IL-XX the your Charlie? over binding trial Maybe to in regards the IMMUNICY-X with questions. CYAD-XXX David and could for turn jump

the Filippo. question, for Thanks, Thanks Olga.

cell for anticipate that things think here, absence around is we're X looking expansion activity. clinical disease and we evidence focused the next clinical for what kinetics I Graft-versus-Host of core of and the and should tolerability, cell more update

on of shRNA-based will time. -- an We focus biomarker work platform. the is But have various our we establishing major amounts over do CAR-T now that right

CAR-T platform. question? going time to show be the XXX our the more from to David, take want that can want that of do all think emphasis, you I So achieve continuing our things this at that to we focus to is we

as do biopsy follow-up samples we well, available. when Olga, as certainly well expression in at BCMA I in certainly. particular, just look Yes, a guess

just the complete So answer to there.

of form just In afraid terms little, a broke Which least I'm about, asking Olga? my of line. violating at XXX, up you you were on

Yes.

of was form asking decoy-resistant Sorry, IL-XX. about I

[Indiscernible] In

doesn't buy into binding that Basically protein.

Yes, yes.

So we are avoiding that.

been protein use as binding So the binding high work type out the be avoids protein aware, carried looking with that's itself associated a to that IL-XX, impacts you'd or with toxicity. either is

-- where the protect that IL-XX protein So the to expect with attractions toxicity. seen being one is CAR local toxicity that issues really point of with generally is date, IL-XX significant are particularly the to form fact key IL-XX, associated native we the will is But here the against the have binding used there using of armored the expression. of some

so the IL-XX upon of be really And first going local the variable. foremost, to tumor the acting and it's impact will an is binding IL-XX And CAR-T. secondly, the environment more where be much in protein level

And exploiting but sufficient so matter to And the own the CAR-T really, it's whether for of toxicity. not effector within their environment. tumor or protein will also cells only a the binding the asking profile, local control produce tumor impact question IL-XX drive then environment

the form we're avoids to looking a use questions. So protein binding that IL-XX not toxicity really for

question next Blair. Prasad comes The William from with Raju

data how And give of on the frame potential what over end other the you're one data? on the platform the wanted year, hear some for us have CYAD-XX to you context with kind your in there. I upcoming of thoughts the looking can that to then at the just one. shift With with just to I program, allogeneic obviously,

it autologous the to legacy out some Maybe additional there program program, Charlie and both first CYAD-XX. thoughts. think Thanks, turn throw AML the from the franchise my then current for that and we've Yes. I But over remarks Raju. I'll look, Appreciate the had, question.

what to about paramount. say. that that goes disease. duration CR should with months be that steered we've our is those attribute there having potential us, of think, thinking XX% autologous response treatment been assess really the kind And for with out of that going the be to I better true XX%, for of a always CAR-T key a with of around several and And patients think to discussions I -- rate, would I has KOLs meaningful towards indications,

additional but those lean thoughts, over So can it me context. some I as we think on Charlie continue provide well to to let who hand

evidence you, said as we my potential I I yes, idea discuss opening continue mean, enough for will then whether of remarks, to Thank is And robust the active is so explore path collaborators a activity. to that whether clinical with forward. there Filippo. we look in of

us not XXXX target. a element for to important have, we continue with also be to well. NKGXD as in also to but as core it's XXX, going, is think which it's -- NKGXD I targets where of continue will understand the just we'll obviously, a involved

that programs can there's -- we So still we assist learn as other the well. to much

allogeneic. partners. we if then can we discussions I we're seeing have autologous take from So potential to the learnings opportunity And robust for the activity, think with an

the paradigm, get consolidation push paradigm programs as hearing consolidation your versus thoughts looking a and then particular. to in I progresses? thoughts on deeper hemalignancy in we're with to the also -- your to on to responses trial consolidation immunity And I your regimens and wanted platform get hemalignancies, you're the just more redosing about -- want at redosing versus how on

Charlie?

any allogeneic aim we I you're programs potential with to the major think the And our to advantages what go as something to certainly the hemalignancy potential for is that it's forward. exactly one do further. in that we redose do explore we to intend have platform push describing of

space level the intend required, more preparation to at. much degree the with both We look and can think in paradigm, that's off-the-shelf I at we the challenge, of something obviously, will look at it redosing an biologic way more autologous a of of one that explore but a that is cyclical that we it's almost much can think certainly over of of but -- use it certainly sort product, time. because sort a ways, we it's I the typical patient in

add to Filippo? I that, May

David. ahead, you. go Thank Please

Yes.

your earlier looking some as enjoyed redosing well I at as note So strategies.

at engineering point consolidation, probably was yellow I either to used. cells cells much later on gives where like situation -- immune down it in consider would the opportunity CAR-T technology I giving autologous we response a to think their the would to as much work about Charlie some -- and the more allogeneic further highlighting, own, time comes in I say just the the consider doses perhaps avoiding think transplant situation. think that require thinking the of situation, and on is would

of response that those with cells fact host they of avoiding the the cells advantages persist very that time, fact modifications not is for One for the allogeneic period relatively the to GvHD, have of big weeks. avoid the a short but

And really And the I drug regimen a not in of as over really thinking think think, so feasible which, that does, with autologous fits says, potential really redosing just Charlie time. type is a about in paradigm, about setting. your frankly, this as

This concludes to remarks. our I would back question-and-answer any like conference for closing segment. over the management turn to

I'd certainly, today you, a Great. everyone great cancer us like medical look CAR-T thank Oncology. Thank all day. innovative speaking and to have novel you, Thank interest and in to mission We needs. for soon. with to bring to steadfast Celyad joining therapies our patients remain your with again you in unmet operator. and we And forward

today's has conference Thank attending presentation. you The now for concluded.

now disconnect. You may