Nanobiotix (NBTX) 19 May 222022 Q1 Earnings call transcript

Good day, and thank you for standing by. Welcome to the Nanobiotix First Quarter Operational and Financial Update. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded, Thursday, May 19, 2022. now today, hand Kate would to conference I speaker your McNeil. Instructions] like the to over [Operator Please go ahead.

our financial Thank you, Nanobiotix discuss to morning, and quarter operator. Good afternoon, conference and call operational results. and good welcome first XXXX to

Laurent the Officer; Chief Van Chief are Bart Co-Founder Financial and Joining me Officer. today Levy, on Rhijn, call Executive and

call actual results to place the in release period. URD we for not the our review statements. United be on yesterday including results the forward-looking that risk press Accordingly, that clinical statements, efforts, in reliance a the today’s in call available can filed subject are They to be SEC cautioned to may Please website of our on I’d expectations. documents and factor to regarding highlighting reminder, among success, trials, from is like France, presentation, to will company’s both financial are our could the significant forward-looking AMF planned and dates These subject development most As found our and risks our things. expectation and description are undue statements and of for the you forward-looking you remind will research include differ statements the materially of information, the Relations issued are States, full this along collaboration, other current timing that available which with section ongoing being filings, webcast the include replay. current website, with recent based cause change. and uncertainties progress, and regulatory that Investor XX-F and and on corporate future in are which of and assumptions, of our

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

turn them future, to undertakes While update some no point Laurent, we the at update Laurent. these that to to events said, ahead. circumstances. call or go to statements future reflect like in over Nanobiotix With may the to elect please subsequent obligation forward-looking I’d

you, via conference Thank everyone I call welcome and today. to like Kate. webcast participating would

mentioned, Kate operating also of identifying Nanobiotix. taking company’s place but highlighting press the the we release As issued quarter yesterday, activities, key only some first not changes a at

Before open the to our would for on both development a drive progress touch we long-term. activities call the advance we and and plan operational how near outline the forward and Q&A, move like I of to to optimize NBTXRX in value take our to shareholder to moment

been initial as development NBTXRX head on for has key advanced and combination with a One, treatment focused anti-PD-X cancer. strategy therapy priorities. in securing developing and three Our of NBTXRX for single Two, as U.S. collaborations combination neck NBTXRX agent locally our approval advance of for And additional treatment immunotherapy leveraging to three, the and cancer profile and strategy therapy. both indication, in potential advanced treatment. cancer foundation expand as a a

first the reflects Our significant of toward X support tremendous team This our investigator fundamental first in we’ve of The during quarter most progress XXXX, And made significant was course patient the the remain this of milestone strategy unchanged. Phase goal. and entire the the patients. cancer. of pivotal head and trial of Nanobiotix the dedication neck and work commitment, hard achievement and in extraordinary randomization

efforts fulfill and and belief continuing ahead the our in to While our approval secure a look there critical for need remain by to work benefit is a forward considerable driven NBTXRX, potential patients. will of

high with appropriate we maybe low NBTXRX patient capable, program expedient combination overall suggested cancer neck truly And medical year, need. and program. anti-PD-X believe head therapy relates or to therapy, advancement exciting not significant Study immunostimulant program This path our targeting a anti-PD-X I start registration in market. a during data the identify the a first has of to the immuno-oncology developed in The second the the ongoing sense and resistant this NBTXRX and from resistant to evaluating been has secondary historically the area secondary transformative quarter from particular, potential and treatment, this regarding has combination with resistant significant potent from treatment the with response generated metastatic our do to dialup number patient potentially primary financing for given secondary combined data to for In program increased more last initiated that to anti-PD-X primary that recurrent many registration to we indication. for but response treatment by a or treatment those that benefit of already benefit of also anti-PD-X patient with anti-PD-X not. will program, and only that have of overcoming XXXX primary as receive pursuing or FDA demonstrates a therapy urgency either and the rate to unmet The

the FDA from suitable we review, a based suggesting survival overall analysis results While written benefit control support same accelerated comparative received we response be overall including yet pre-specified for may submitted command with on rate protocol single approval clinical preliminary have a of have a agency on from trial, to that the trial. not full verification

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with date. protocol this the be ongoing in develop to the currently review Although, next early received We to year. submit by several protocol line from final and to our working expect will we generated guidance informed for the FDA to next a the months study data

this study and partners, reported of our to in continue in NBTXRX agent pancreatic and advancement research in Finally, feasibility to or first program safety addition Anderson combination advance and case on the cancer. their single MD

far, success forward to treat. to encouraged we this and incredibly the disease know, we pancreatic of challenging this are so be look to completion devastating later study And all by a As really program the dose escalations this cancer continues year. and of

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each pressure the us are the financial sector likely. know and in of as volatility market biotech the appear of agreements prolonged However,

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an focus of franchise on on cancer. We and the head building effort focused our neck are treatment well-positioned to initial

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is XXX treatment. you have As the and all patients will completed fully enrolled Study recall,

we In data of to most at subsidiary, be prior the in modification, expect ongoing Study activities including will Based XXX previously months the changes clinical research, on follow-up have Curadigm. fact, line for – reducing the and planned program, development, this we’ll the related top we to reached will provide the to mid-XXXX. company’s where clinical XX in our In trial. from stop time patients

to reduction near-term in clinical our and preclinical afforded to and activities manufacturing addition our setting further these supplies us support program plan the activity, allow also by to leverage cost adjustment near-term reduce clinical expenses. to changes existing the and In corresponding ongoing our our make

business exception. do years all pandemic us is no in are and of of Finally, Nanobiotix two operating a change

primary offices facilities have quickly that across further reducing connectivity a manufacturing satellite work in operational efficiency savings, facilities accommodate can to footprint. time, We remote further take adjust this leverage by and office infrastructure our we global retaining promote while generate At innovation to Paris. and and to

of run our financial team footprint we call a taking of additional operational of are light to measures reduction our and plan extend like would are the over to program, addition plan development we away adjustment will physical In now in Bart, were expansion denying to our circumstances turn address any and who end. flexibility. and I needs until strengthen to Bart? or

our insulators purchase parallel this position Cheuvreux, efficiency priorities. Kepler Collectively, control The flexible company secured structure runway. adjustments to million have at that allocation by program and our XXXX operating resulting expenses needed. XXXX our financing to operating in in strategy Kepler to made impact By by detailed XXXX in a with are million in in These reductions execute XXXX, and continue markets. nearly through cost cost by available capital that Laurent. little ability to initiated a better to reduce establishing any market. a prices to to initiatives costs near-term our the a approximately impact equity Fundamentally, should prior from the to in access development the exposure significant second expected €XX we capital our to favorably reflects to equity on to are generally provides these in current approximately double-digit reduction In will are the SG&A you, of also commitment in have the million long-term efforts line XXXX Cheuvreux addition the Laurent to quarter €XX impact market operating line we half optional cost our to Thank just to line our incremental adjust to actions capital in better €XX we through programs. at in equity conditions,

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discussions our Specifically, obligations. potential related to of we have debt the restructuring initiated

our majority timelines efforts safeguarding the to of us to discipline to shareholders. in R&D the XXXX. reflect Our for schedule commercial patients goal instead due our development payments commitment programs. our This the realign is of our anticipated would capital The our allow redirect with NBTXRX XXXX and principal and repayment and the our defer towards

now, programs, which we assess will the and to I’ll deploying are we back As drive turn to Laurent? to optimize long-term and progress we continue near capital spend call continue with see our And the efficiency to value. our to Laurent. our

expanding to and coming us flexibility forward patients. the detailed we to opportunities Thank extended look as allow in forward reporting the end work element and by advance our ongoing months, forward a cancer. runaway for quarter, first step study look to data continuing by to you, U.S. an from outcome building NANORAY-XXX, Phase in the to head recurrent neck the confident Asia. our XXXX cancer, with are program excitement, taking Study neck registration but Bart. both pivotal significant The and X include and program, in advanced updated head in our we with and only continued and neck in the pivotal In progress partner study to IO LianBio for locally establishing our protocol We metastatic not Bart certain finalizing of for to cancer head look

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to long-term open the you for for would and is question. I Nanobiotix like see, building near momentum call at now As and remain the will optimistic NBTXRX. can Operator? about opportunities

Thank you. Instructions] [Operator

you, Thank operator

Apologies.

that’s okay. No,

jump from we actually of And questions the call. questions queue think to we number to of address I the we’ll think prior a a couple the shareholders received those start online. I of before

start So four the Laurent, of questions to call. and one sort Bart did They I know, And you might or some topics. thought relate as two. with to prior we general receive we

focus the And Specifically, and expectations around how and head neck questions the by And that expect inform and of triggered recruitment payments head XXX. plan largely what site of patient first program questions Phase many LianBio the milestone if we for in to – the start analysis status would the X the include and questions analysis. any to timing XXX, to the relate activation series patients and from study futility our in of are neck. related Study registration Study on of

Thank you, Kate.

trial of we been you into tremendously So as Phase you we’ve patient the have seen the past this is in initiated company the priority know, years this January, of and Phase put X work the the recruitment registration to X. that of have as place. beginning in And

moving plan. So to things according are

have early We’re Europe. across many this you be as still, opened in stage and especially of activated, trial sites know, and

patient contract linked also in X Now recruited in States. and we This has many regard site but head first but potential anticipate not patient. HX in United In Phase the linked to opening in to in start milestone Asia, the of milestone to neck. LianBio a in it, first to the

will years, you give move the how with on are continue next we update where and So to this months, an we trial forward. we in

as As far anticipated. we now, things moving are

readout the still per As that analysis provided the the market. the and readout, been in interim futility timelines to have we’re

Operator, some think can are questions queued I on we the to that line. jump

course. Of

of ask question Please Lucy Your question. your comes the first Codrington from line Jefferies. from

questions. Thanks for my Hi taking there.

few. a Just

Phase with X planned the PD-X. with starting So in combination

manufacturing been PIXK but have what X optimist. with patients you the that to And important decision an that, could reduce follow neck FDA the if tissue of for between what sarcoma, regards – the this the And data be – were Phase you ASCO say idea months head post-marketing implications for data reads you. inhibitors readout. would bit did of and coming it does with delaying Secondly, you possibility with Phase for just affect – reductions ongoing But the before was events months XX costs, and the of completed similarly And first go original for update by implications the that then just X your out? of XX give protocol of the actually reviewing XX recent discussions your just year? months that the of surrounding didn’t studies any already? finally, most amendment with is the now misheard, trials? how Just done XX whether project year kinase that for have being there and XXX, the to And more is just we with may should initial And or up a for have XXXX. to needs or study influenced originally? with you what us mentioned why manufacturing, that And are that line a months? kind the quarter And by soft the more end have what in not those? the have changes the incremental material any XXXX updates at Thank update more your I

you, Thank Okay. Lucy.

questions. So lot that’s a of

to So start and can PD-X remind trial are them. we Maybe let’s pathway IO try with I all the planning. the of

So received the as on we protocol we FDA. based mentioned, are feedback of stage a the we’ve developing just from early at

to here from response when number perspective, a the patient neck we also an of which interesting start head both be rate So and looking a at patient, look perspective. potential a study have, this for could and what we PD-X, metastatic having encompasses what we XXXX being survival at refractory outcome can but is is from

seeing are to Now is XXXX refining enriching the trial occur but an plan submit be HX We year, more protocol we’ll where we’ll of that data XXXX in next on results designing get trial. protocol patient Phase this in we step also but next should a obviously based could feedback, we’ll X. in the and this this of and and on this what on first front update steps that us in the are between beginning could lack year, FDA this see the have to based this

So many will done we countries are potential at also that’s and are There the be but Europe countries going be is feasibility moment. part to also looking are it, involved. where at how moving to other of be there. see U.S. to we Obviously,

two cisplatin that you of the the why for whole term neck of and so patient curative no pathway. if have XX into to That’s after cure. trial especially have see that’s this years could the follow ineligible are because XXX to as years a at months go in head After XX up where that have initially. point important, you and one if the amendment, patient, we follow from then the a five to good locally relapse perspective advanced up, you considered for why chance Now be could is in the XX-month some defined a some treatment for you is transform

when been patient Now recruitment stop of the have XX having few we when the It there a way and months, that hit, that trial, other the follow-up at later, vast the recruited of months more of final will versus patients. the follow-up numbers gap or have in the will as COVID been will follow-up. have in XX majority last know, months very patient means be there patient this XX patients only only you

in on save XX after from trial money follow-up the felt order amendment this and come results last not trial. to spending cut than So continuing what to an why do money this degrade make could months that’s to it rather patient we for

needed IO produce a the demand to trial, we in what place needed new and Phase that everything including for in as is registration and with cover obviously to manufacturing, facility. setting, can is continue on our reengage we the batches clinical potential Now ongoing every now have X

Lucy, to about able question a got Would not it restate you completely. it? was there I’m sure, Now, I STS be

sure. Yes,

Is Just immaterial? given and priorities in studies, now? implications guess, those conduct that of of the conducting Can head does terms I later? those Not the is them postponing you just – neck. post-marketing the

forward. we why reason on impact that have this the see material postponed that’s our don’t is way any we study Yes,

are a that radiation, which be for and have been there former Now, question minute later where trial And what Asian a one rectum I the cancer HX results that ASCO, in received in this mention head radiation, cancer, other ASCO, at think neck year, of nanoparticles. be would are I will have by but PharmaEngine, two At plus chemo expansion about just the ASCO, the trials we partner ago chemo, XXXX the done patient the mean was waiting that a not patient didn’t as I’ve received updated cohort planned. nano.

that been treated those sarcoma we because and what as product many look with previously. and only our cancer help neck setting combination radiation is care head indication. to know, our establish to And chemo and chemotherapy, our it and is to but patients treatment we neck we will into different standard in of combining forward possibility is or are to for establish with do and So like us, try with also of first, the agent and to important have of other head tissue this expand in IO. single indication at a That’s us here a soft move franchising, then way combination in the X trial, as Phase

I see, cover questions. you your hope did I So

you. Thank Very helpful. Yes.

you. Thank

you. Thank

from question Michael DiFiore Your of Please from next the line Evercore. your comes question. ask

for Thanks to we’re to measures for OpEx. all get all save clarify study. in will analysis for, do just runway order quarter the line certain – measures XXXX of runway? want restructuring Hi biggest is $XX million efforts that $XX to much the possibly million provide you things the the the incremental runway of additional And to will money after an will and these I the get tapping guess, of that these it credit, the Thank take taken NANORAY guys save have the – equity interim guess, line XQ Phase X of analysis I Will Or equity to my the that to be will place not where is I the so will will equity stating that fourth will could have that line, taking that place? issue plus investors credit all is you and question of the into guys. only interim beyond question. will the XXXX? or the you. such – current debt Or you whether

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the impact As QX And our are both use our equity gap. the the us additional continue and XXXX. commence highly line press to value release that necessary will our and in well get that on we’re could runway. of preserve value. long-term as provides bridge taken to that order taken disciplined includes the And extend as flexibility opportunities measures to call allocation. We’ve to That steps our us materially in to indicate drive control our these actions to capital that all we’ve the

but get we’ve release, hope us in interim now the gap As debt a to to restructuring still a I indicated gap. smaller analysis, that there of the very that the your believe of is that question. press them. is bridgeable is one We answers

be restructuring? I by possible And follow-up that a guess, satisfied to Could the Yes. very gap. bridgeable debt that there’s

a Not in in good the its entirety, way. step but it’s

that are as manufacturing advance often making unexpected changes taken any done consideration changes there will fund? And just cause plans into be these an will in a recognizing been penalties may that just too, mentioned place. lot that very be manufacturing shortfall costly. a add-on you Has and that Also of taking are well and

Thank you, Mike.

the Nanobiotix is facility its manufacturing own manufacturing concerned, is API. itself the So as is

vast majority of the is by So it controlled us.

penalty not any on is So externally. if us,

easily penalties why can that’s spending or linked the So in we without the to other incurring manufacturing control that. issues

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welcome. You’re

you. Thank

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for cost you just reduction Thank have in I following two started the Hello. the presentation. XXXX. questions

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cost the to has low we’ll So for is continue work there Nanobiotix. engaged very

what – was the Now please? sorry, about last question

LianBio.

LianBio. the you – And what’s

years. the question both expected milestone upcoming some if My was in have LianBio, you

not but also different from contract coming this Yes, Asia countries, of in commercial collaboration. there are step injected more out first and development this milestone to in expected patient many step milestone in the

Thank Okay. you.

You’re welcome.

Thank you.

Swayampakula question. Your next RK from the Please of from H.C. comes question Wainwright. ask line your

this to the Thank trial, Good decrease to things. that but follow-up want you. go XXX how understand months the or from Study couple want morning XX on. good just months. on amending been asked, you’re On Most Laurent. based where would XX of protocol to to just period the On touch questions follow-up have afternoon, a my

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Okay. Thanks, RK.

trial And the you patient moving trial for XXX in trial very will extracted, premises the define of the as final population us no treated XXX which to we then the that this from this in has the be what which been forward. we the XXX. have the what be XXX take it’s or to could ongoing. So the been And no is design we in has trial helped we everything will change follow-up, XXX, because least term at know, is the think past extracted the trial. the one will of stopped If we part few remaining follow-up

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XXX product the in that patient and this order that in enlarge are can market to will population plus target broader neck the population with we eligible in advanced get our for population Now cisplatin. a the locally head

a Thank the terms a studies studies? in there year you you current collaborators? trying with I’m asking that. Anderson any The or for outside see have updates different that the reason be that would of be any money I’m runway various if to and then MD half within the just year that And is next doing from data for soft would by subject in for, of is relationships indications, those

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part. what that with a are define think be advanced and Here, we move the that the inoperable, because the interesting following are And life of a locally expectancy truly to then I and a extension trial we into short that’s a having RPXD patient dose, setting very to intend metastatic very high risk would tumor. usually start

could that resectable stage later the some the if that surgery. them to a survival phase us to patient if patients. here, you metastasis and need then chances will for this this go at is least for patient will So huge to get at you get allow to we improving extension patient, currently need where Because a borderline move the into that, to of control get really there

eager this data obviously this we on to move will this happen part if very the year, what And the are to soon. so we will of be So look can to at trial, that. expansion

the where to trial for be you give should second MD response here that a to goal one the that is chemo, in that’s the the have setting patient. data us Now with esophageal Anderson Again, nano. And a get cancer. plus the will good radiation,

that surgery are I surgery So to either this the get the of or you And be not for can to are year from and we from also And it. coming organ. to I keep MD Anderson. a we when Along detrimental data should next waiting about function will inform that the other running think… some will trials avoid results you way, expect clinical

Thank you, Laurent.

show can I the can that find a the think To to partner about option used be RK. a other more question IO product seen our oncology. chemo partnership many in go is we perspective, the will be there. for part back in go of and broader us your to to Sorry, out from so with settings combined combined can The be with this how be

for my Thanks Laurent. Thanks, Thanks. questions. taking

You’re welcome.

Your comes next Securities. of from Please your Frédéric question. Gomez the Pharmium from ask line question

Thanks, the Yes. not that studies [indiscernible] my ongoing. questions. for on taking Laurent Few

overpowered maybe and the itself, like – XX%, share can us XX%? On us that tell the the understanding power a you can what to assumption of it PFS is maybe And gain are OS the understand to close in When better you maybe power the terms if Is decent at the also on PFS. design this statistical just to months. on we also you check study? a we maybe And U.S. [indiscernible] get the Should the colors versus look chemo have seven statistical control power for more you with around the of the between the PFS then arm, arm.

of gain three the that looking months. in mentioned You were for past you

absolutely FDA? impact question be rational your use you no on will approval file in study of number with of two, amendment, the that have the supportive still study FDA you Thanks. are explanation this my and will this is maybe this confirm but when four for got I when one two on amendment with or that the three the fight can amendment, will we should sure arms? you to between U.S. months And PFS you gain last will for So

Thank you, Fréd.

the that nevertheless, PFS that’s benefit. demonstrate with being able to a question many trial just endpoint, has been are designed, OS primary the being there as XXX, but an around So trial general statement, how right. designed a you’re That’s

that it done out PFS. the is the the So power is to the the and overpowered OS interim planned is PFS on – versus PFS makes be

on will sake think the available I your different different the the time, powers are all details the and there. find publicly or at. we send answer endpoint For are that of the design looking you’ll you And trial of I the

XX on outcome be in what what population. use XXX, of in we XXX. can in of the the the the supportive XXX the enough to of what we at question good Now a the potential of something think for understanding being term the which impact term have population That data. included be product I don’t the will frail months could is the supportive is overall And XXX, directly of

Following we much that have bring patient will versus what value longer not today.

strategy be the the registration pure the also did yet the one the and data include of will and two to what other and to or as every addition. regards obviously submitted we but in that, at trial that supportive will communicate XXX, time Now market, FDA the registration, that as not to data

about the are clinical control question the design re-precise another running. the arm was we there potential trial radiation of just think plus I cetuximab to

one patient a trial XXX this one. with two arm So randomized to is

cetuximab. radiation will either of So of have arm, patient products. arm, in plus each the the alone And the radiation two we one in or nanoparticle will receive

cetuximab not. stratification it population the to elderly putting population, radiation of still you benefit cetuximab some in at bring Nevertheless, standard literature, in treat. So we And the to the cetuximab you the trial the But to patient, look frail in patient is alone. of on when if at a of look top out want versus here, does is choice it general there true care the that linked was cetuximab. radiation of is use trial fact in the the with the of that on

versus showing during for paper, is look even conference, radiation head treating data quite one past detrimental either burner and plus elderly And neck for at the some with similar. published radiation world cetuximab elderly cetuximab in or you the will one the If real radiation, you patients being PFS that it patients, of tell is that alone. the radiation of has our PI evidence

think I between month difference than there’s less a the two.

could at and need. the why we extend in talking think when happy that’s you to are at we literature, be that to will I what important like, look But what in comparator, comparator So go the Fréd, really look really about. we could look we be detail population this deeper as it’s what discussion

As there questions I Kate audio. hand back to now the for would are further like conference from to submitted no the McNeil questions.

IO far, prepared our through you, Yes. a potential I Q&A and majority and program. we the Laurent, receive related you development believe the operator. strategies additional covered to Thank financing so several as going of remarks questions actually did know, we’ve Bart in questions and

which present we have we three call. to like before for you the to I’d out address do questions, close remaining However,

any first neck. specifically request relate study studies the these in when IO status data clarify MD and Anderson expect of series questions to the The and questions combination see to and a from studies head of about include to re-radiation we our of anticipated results from

access and related development the tissue soft to product? are final product specifically with that questions in Curadigm the that European the to to of status there And question on update Second sarcoma market. Sanofi? patients any the to have ongoing in availability if relate currently the is And that, there the

Kate. you, Thank

the to for tissue start soft access let’s the patient to product. sarcoma with maybe So patients

head So looking as the Europe. and soft priority and our in neck head at had sarcoma tissue and company start after we’ve neck commercialization seen is registered will been

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Thank you. remarks. I the concludes now would to back closing speaker for today’s This question-and-answer session. hand like to any

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