DBV Technologies (DBVT) 26 Oct 212021 Q3 Earnings call transcript

Welcome to the DBV Technologies conference call webcast. My name is Adrianne, and I'll be your operator for today's call. [Operator Instructions] Please note this conference is being recorded. I'll now turn the call over to Anne Pollak, Head of Investor Relations. Anne, you may begin.

you. Thank ] Technologies the release ended X XXXX [ DBV financial outlines September a (sic) for updates. results and XXXX issued afternoon, that press our XX, This regulatory and X months forecast clinical release but Technologies we may not comments DBV include limited of available interactions product regulatory our development improve with and of today's ability patients the of of number the candidates, of food our note with to website.Before the Release our to cash begin, Press This plans; regulatory section and is our forward-looking of timing the results approved, the a of and that lives allergies. runway please call agencies; on statements, regarding any including if based and assumptions to company's on subject those significantly the cause are uncertainties could results by are risks to actual differ suggested from that forward-looking These statements. that these statements

and any by Executive Officer or statements of DBV, obligation required company will call. him. joining any Chief not statements.Please actual pass Tassé, with any reliance and I risk made circumstances today, this now these differ you statements undue for information company's could over Daniel on risks factors events filings to publicly law, as expectations, from materially that call. revise company's the to place forward-looking on the or concerning that to update or Except forward-looking should cause reflect these the the French this to to AMF for the uncertainties, and results the disclaims Given forward-looking including account SEC occur call refer me after is

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the Day the data, one issues objection the our the clinical including example, supported are and size evaluating received response in also We pivotal XXX remaining the to summer.We're that limitation we address study. outstanding single the letter preparing by effect of for currently agency's best objections, of the to questions relevance major how

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received agency. yet We from second communication have not this the

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day the rent, related variable the expenses consider to development one, operating Peanut. I to loved families, XX% peanut those exchanges their DBV's and (sic) is on of each food we first will regulatory financial advancement equivalents, pathway allergy EQUAL.Before defined program of the and tirelessly clearly cost patients, continued the cash ] the ones day-to-day me all results. [ of operating We quarter a and XXXX.Our decreased corporate measures. the reflects therapeutic between facilities, and for used to and Viaskin the and our cost constructive associated support behalf. Viaskin months third to clinical in questions, clinical activities our in by X want Net with implementation and awaiting scientific We of to see to a turn cash ended third as providers STAMP X such in and into with costs $XX.X of open community, and potential in expenditure: cash unwavering DBV align runway the patients FDA the including expect operations quarter briefly XXXX our the company, salaries, allergists, urgently to quarter cash motivated I who our with by call reaffirm XX% Everyone commitment which containment at to million projections fixed et treating types the continue cetera; and continue of allergies advocate Peanut.Now let on XXXX confidence

I to Financial the to help Investor all answer Mohideen, I Operator? communications Anne Sébastien Chief our open continue our Officer; with for Officer, viable and questions Robitaille, And to to FDA.With those join and questions. me. Chief open would Pharis Head with besides Medical will pathways maintain of like all that, Relations; explore have who's call me the Pollak, We

comes from Samuel [ Our ]. first Instructions] question [Operator Levine

for give PREQUAL study? EQUAL? for Thanks know would what today. I it a quick you expectations me. current And an your are the A few on update update the then us you be thought turnaround. also, Could for

us long of how patients, number remind you you think et be, could could if wondering just that So cetera. of

Yes.

in this here. all important put to that's perspective, again, So

in we equivalence technical the study, allergen of what know, you EQUAL, of uptake the call is touch As complexity.

first, sample optimize So to want we the methodology.

both peanut patch? to amounts And to to the off do going the use data. of you calculate validate how surfaces, the we're of Now collect protein actual that assays also then that and microgram essentially skin how

we what that's PREQUAL. call So

we we before the our patients. trial us to has agency work since data that in-house, now. its on what completed, background, since to waiting as been actually PREQUAL, the for methodology with to with part know, right as yet to the in what of do ongoing and We first question? the from that Now the the your is and Did going for the now which was That's and optimizing compare is protocol -- this for answer we're asking feedback waiting a here, the be is objective healthy know volunteers optimizing mVP parallel, of the feedback sample EQUAL. way that in don't agency, sizes FDA to is in exchanges from cVP don't FDA, proposed randomizing in-house.Now to required

the there In for the you here why they is be are goal the possibility or a did which even given shorter requirements that initial yes. do adhesion? Or FDA, study a for think, from the communication X-month measure that primary no efficacy just STAMP? to and Okay, there, a have X-month duration to is rationale for

Yes.

Let the the STAMP been here protocol. one managing, me Pharis? obviously, turn the he's question to since Pharis

assess It of to months adhesion specific you enough to be properties. to the no X assess was There detailed the rationale to around the the was long need duration be reasonable months. able have on for to of patch, Yes. a able and patch number

of As agency. you know, few get there's day. XX a in it of per recommendation, with the weeks negotiation terms so the initial where you an And the speed to that's was part hours up

add, may, that assessments X month the trial Yes. I month was in our month and and adhesion pivotal month would X. X between I also X, and if

We for were reasonable sort months. with that's comfortable boundaries So of X a study. this

me one more Europe longer-term And can more you give before I Or Does is a queue. send in Got jump over it. there them the EMA that robust the all data on set? for collected? you've to have data last

Pharis, EMA that I'm EMA if the has the XX-year PEOPLE have. -- to they X in the You're olds, welcome. efficacy so data, correct, No, data do X-year the

correct. That's

yet trial. most have all not safety-only data the safety also REALISE, from of our but They

think up Am but in date, to more correct to with there's shared we've I come. data I them the that, So Pharis?

That's correct.

[Operator Instructions] Our from next Suvannavejh. Graig question comes

couple. Daniel, a I've got

the process regulatory on in this review just EU objection. major of terms First,

anticipation is may X have pivotal want as by then to the that it gain Given risk I DBV out sense scenario in get another be data I'm seems the on a around you that you've is as guidance approval perhaps that of just understanding that's should to about are consider before if they're you're increased questioning single has.And if that Europe? already of trial that thinking we U.S. side pivotal time what could factor going a from perspective the think it's be? going if kind you to get is your altogether? that now the that potential design a line EQUAL, Or potential thought impact that perfectly And have planning things, run how perhaps of order secondly, different potentially we -- should may your an to guidance? how to meet potential the objection to you'll major gating that in trial STAMP there that, about start, EMA the can the -- So supported study,

and EQUAL.How I'll your don't the question is cVP expect conceptually. know STAMP. may, assess to we data answer that to EU know the second call to some or inform transfer we answer I'll to way, what comparable assess meant We're FDA. whether come the question. one is see that. surprised out critical then That's mVP. joined to EQUAL not important. It's STAMP, to been, don't is of and between We the One I the adhesion, that's if becomes back in meant Graig, EQUAL One protein first, they study has STAMP from

helpful. been is. we obviously, not And we've it So but know that's don't speculating, what

we the EQUAL what EQUAL frustrating study, but decide in not.Again, we in for will to sure the EQUAL-like whether what time, there do that study is we PREQUAL feedback the forthcoming, point is in essentially, to it's is that, healthy. that want that it's to had why communication or what no delay, we methodology codependency or we're it healthy healthy. do make the not wants the because what it here. agency sound. is the achieve was At adequate in here means. the obviously, approach now which is time see analog, we volunteers, recent the unexpected. is is and the wait have first, exchange sampling.Then as There's touch, some did trying of also And exchanging in an and to that obviously, of here, Given that again, And before the fact optimize It's conceptually mind a We're which to that It's stated for FDA FDA that. kids on have development validate the one to to X, in disappointing. we we'll that's the ways, us, what is feedback with is, then further

So get your the did answer adequately EQUAL before to I question I EMA?

Maybe just follow-up side, on could. if U.S. Yes. the I a

in we'll Is of next So this see prepared But by you have year? gets of of mentioned it around when year? of a potential the do you missed to it? uptake? do Or it. have FDA guidance I the get on -- might end protein have Is have demonstrate you the this half remarks, when is might FDA's just might expectation it first and best kind to you how your the

It agency or mid-October Let sent early respond May. We the for X.X sent me us was was late the discussion mid-July. have. our share took feedback the the October. protocol got in we agency to the discuss protocol. to The in with to to agency STAMP them protein wishes to uptake in protocol the facts was It sent months you protocol, that [indiscernible] -- with documents,

Whether belong ongoing question, We confident objection, we them. I approvable. by But The of anything pretty when patients. product, informed our supplemental CHMP. to that So the to be look, we not point time be.So with we EU we that round their to up be have does something the much said me like to objection. obviously will an discussions don't at convincing [indiscernible] the or forthcoming. speculate EMA to is remain time. obviously, EMA, in to remain next think that to product have reasonable to doing amount a we them, their obviously, the we answer will that's confident feedback decision be to have of would -- agency but but not product will with not we'll that put this decide.So and that will answer contemplated wish the in get that to essentially can major that EMA. your The That forward the help to

I could more to name slightly question. company if the And just Great. one changing off-the-cuff Any ask DBV on thoughts Therapeutics?

suggestion. Excellent

So here, probably is and on called what to if that Graig should. I reference DBV voice my I Therapeutics the it. corrected company's never I is making may, mail, I've

Instructions] we [Operator questions. And further currently, no have

it If XX right, minute, if is a all another and or give seconds not...

[Operator Instructions] queue. have the Graig we And back in

agency, that enough think, while to a FDA, job bit of the you little I finish what we're could from with closer, or expecting at given approval.So I'm investors is cash you've fund answer perhaps is question and seems projected the hopefully, think closer a run current reducing basis perhaps at that story arise time you we've I burn. better kind but appreciate as derail kind investors big for to seen getting that while team remind not you other your looking done Daniel, are the of far with years. next we're get how a a what where on of do kind I might the over And least I balance around guess uncertainty sense cash great necessarily of Viaskin FDA crop need line, have on lines questions of delay. to could Peanut if us you at the of just that -- up the kind U.S., the could your it's But really to cost make that to there company? how how point important, multiple It I or -- else the in of have is kind speculate along until? And unfold capital what's can to the with of a and way happening with obviously, right the more you to now, sure possibly

Yes. It's our stewards be good expenses significantly. in know, cut shareholders' we money here. obviously trying down absolutely fundamental and of ourselves We pride to question,

and there's about not FDA can both bit, what planned more that we STAMP.As asking expenses, basal for those if have I'd into year. control QX put wait now As and think it on of we headroom. I a Right what shift next EQUAL And to to back we said, a remain that.The here we the since us money we else as we now, to then possible. bit the the -- for expenditures to agency feedback, the cash you're aside also providing with the rate. I And when before like little think way much hands spend a comes get obviously we a with -- bit closure best very to about happen agency. levers will may, have

program obviously, of if get than Viaskin need priority for that is in been the vaccine research Post no us do with And division years a the is we it to it's Washington in said COVID. has slower them. with in is and OVRR get a the to that that FDA, ago that very few expected. have answer an of engagement with expenditures all There the review. overwhelmed And that weeks X right work will we're reassure serve was understand the next very communications to despite we our of article where serve to on also remain busy, X We us exchange a patients, where They in the vigilant, that pressures fact the continue slower that than here impatient. investors impatient. is it use urgency position with word reaffirm the they The a artificial so there's the process frustrated, the -- And agency that will but even us. their won't is in to obviously believe understand here.We we're we're the agency. I from We so that And agency I months. we have expected. Peanut to

from Jon next comes Wolleben. the question And

me, Just Daniel. more one for

You you on mentioned have any major news to is to that to provide is what could this least if was us. color new a at wondering EMA's answer major objection as response I objection. your it you

is objection. don't the elaborate ongoing think that of one exchange counterproductive wish here. Yes. the We We again in to which on obviously nature is the again, -- relation we where what would is to be would it EMA

regulatory going of and to to we and sometime believe QX. butter And which it data, of that XXX substance the bread we that wish those on issue do that them and here our that fair with I it. an have the decision, to not further Day the is interpretation interactions answer response ongoing exchanges, an be believe benefit. of objection, will that sponsor process what and So when is Again, comment an forward. agencies interpretation in the obviously, to say make it's clinical of have will -- We to except their discuss to we correct EMA comes other

Instructions] And question from Cogut. next the [Operator Alex comes

something Daniel, still be do perform? in EQUAL valid? previously so days. that before, was you that Is study fairly I the much mentioned Or a maybe to you the scenario a believe it couple study but where quickly makes see could of done answered FDA the that asks longer

a the something here. is data a the that. why resolution or This we to agency by do these PK/PD with ourselves that given I whether a which wish do, and a to days between is getting [indiscernible] with can and here. in weeks, That's study longer the our asking know. STAMP, To what's show more blood that in study important important we is agency EQUAL changed opposed on help is chronic we version speculate product, as the don't a ask the work stream, by that -- patch, remind be parallel the in know, that from until is up this is study us do more the or way us, what in to the their parallel and a be to what we don't is, reason as bit with these patch things what the of our in to a done current I ability is us to leading opposed needs be question. mode guidance. can't in the the to agency essentially it's going obviously, Again, equivalence in the it way, wish That that possible thoughts on EQUAL, protein were is is, if to FDA run think delivery EQUAL EQUAL be measure in hear to your know we of the something action. not do answer whether again was development concentration was complex.What stepwise answer run over, idea the don't investors to to one I modified what for would to Hopefully, to surprised will stepwise parallel. stepwise all to And would the

no further have in the we And questions queue.

for calling phone a you attending further Pharis call you a and everybody to always you today. discussion. in, know, today. you, we're wish to away as thanks if Sébastien, I all and for thank joining have thank us And Adrianne,

and today's participating. ladies conference This concludes gentlemen. call. you Thank you, Thank for

may now You disconnect.