DBV.PA - Earnings call 3 2022 | DBV Technologies S.A.

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Operator

Welcome to the DBV Technologies Third quarter 2022 Earnings Conference Call. My name is Daryl, and I'll be your operator for today's call. [Operator Instructions] Later, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the call over to Anne Pollak. begin. may you Anne,

Anne Pollak

release Technologies for press September the release the The DBV website. DBV our XX, that financial press press on available results X is of issued afternoon, the release Technologies a outlines XXXX. section This months ended

statements, products please our company's forward-looking forecast approved clinical to with and development the subject of lives results but from significantly actual we on and number begin, our by food may results a to -- runway and cash improve of timing patients with are our our the our that that risks regulatory product of note to statements. differ and Before not based regulatory is of suggested are of assumptions call limited today's to include ability those candidates of uncertainties allergies. These that including, regarding agencies, interactions comments plans, these statements forward-looking cause the the could

uncertainties, place AMF call. Except the for expectations, update company's circumstances any that forward-looking made from or results risk as or events forward-looking these after for company reflect SEC actual French filings revise the statements you the differ Given materially statements that could and factors the should occur with to to on and required call. any obligation undue on these any law, or information this statements. refer by not company's risks publicly the including Please disclaims forward-looking to to this account cause reliance concerning

pass Financial Daniel Medical Mohideen, Officer; to DBV; on Officer Robitaille, call Officer. the Chief of Daniel. over Chief are me Daniel? Executive Pharis Chief call today's Joining I'll now Tassé, and Sébastien

Daniel Tassé

call all Anne. on us today. Thank you joining for Thank you this

September the Viaskin VITESSE FDA data, reflects any with specific enrolled this attention partial the partial the address other ongoing productive patch feedback DBV the sent the children at the test. agency's with and allergy. On our FDA's if stage, any that phase find to an letter, believe letter exchanges on affect nature FDA. We the a changes have to Let for a changes we third modified hold exchanges the future letter the X Viaskin It the We submission. specified of pivotal subjects III this partial any with elements protocol. from BLA a more protocol with studies announced when recent FDA support submission. Peanut the manner. is timely BLA the clinical in me a in confirmed especially received undermines it age of In to letter focus additional peanut rather agency Furthermore, before on much a addressing constructive the the the intent in We the the of hold a with XX, valuable clinical careful are appreciate with indicates that the the would VITESSE. X trial hold VITESSE it to with protocol FDA and FDA will start trial Peanut. evaluating to letter does a future not The clinical update VITESSE

made for to is the with clinical letter. At initiation partial the what since is asking FDA understand receiving resolve process. started paused had letter, priority top Our received progress submitted VITESSE. we and that by of the hold hold received We study the protocol approval When we and clinical their and the institutional we resume submitting time the rescinded subsequent we've protocols weeks review sites the VITESSE satisfied the partial to X the in any boards. letter, we

and are once conducting is the study start-up for hold partial certain site support internal continuing to preparations launch a clinical are However, activities and assessment lifted. we VITESSE prompt

hold clinical to premature is the subjects do partial previously announced on know year-end. letter we it today, of screening not milestones, as by will the of begin other While we VITESSE assess impact

the as communicate including will publicly appropriate, hold lifted. updates additional once clinical partial has been We

announcement goal the the any timeline. providing to on When that changes call of to we and a happens, plan VITESSE conference protocol clarity following with host the

a Let me ending for brief update the September now months XXXX. of move results on X on the to financial XX,

of As decrease September was discipline activities measures. is cash continued million. cash reflects from implementation of XX, of X in of XXXX which XX% cash and months $XXX.X XXXX, equivalents our same a million, operating the the used $XX.X Net were period budget and for

runway guidance cash from Our unchanged remains guidance. previous our

in of disciplined our our remain cash spend We and efficiency continue maximize management. highly to the

you ahead to will of we VITESSE under appropriate XXXX, Now updated the partial looking keep remainder as hold. continue to clinical

College forward Annual look upcoming American Immunology in also Asthma Scientific of Louisville, to attending Kentucky. and the Allergy, Meeting We

today. Sébastien you and want a to for at as thank me has for strong know, forward again Historically, year. question-and-answer. I to the college. the I DBV ask now on this will to us look presence had Pharis participating the phone webcast We joining join and everyone

So you the could for be would that great. line operator, if open questions,

Operator

question do from And John have a Wolleben. Instructions] [Operator we

Jonathan Wolleben

going that from or least with on add the been need this based endpoint maybe primary are FDA, Do to you're as hold thinking how challenge FDA a me. at to clinical Daniel, with having feedback you few the endpoint? the about trial has design? the a co-primary having A dialogue change and think on you food the you're

Daniel Tassé

so. No, we don't believe

primary the day discussion month within I X. defined by think hold. not clinical food clinical of topic a the as XX endpoint the response versus remain challenge is That will

Jonathan Wolleben

you terms on the want or guys measured? to any is And in I they it this. was said color more certain could dialogue portion adhesion in FDA just want hoping provide the adhesion of is it they criteria of you hit

Daniel Tassé

right agency. adhesion core the flip at of the very topics, is topics is and That wear around of what the criteria adhesion, X statistical with we're the it the agency with bigger of and discussion discussing now. The X of time the

Jonathan Wolleben

after on trial? EPITOPE thinking how you're X-year X- update about an the moving old successful the give with you can And forward Okay. population to

Daniel Tassé

remains this our time, discuss to first something the It efforts discuss on foremost. them. knows are agency with focused we in hold, we to The wish point and agency. wish the But clinical it with Yes. at

Jonathan Wolleben

And may. was at me, to what of kind one spend forward R&D can for that how the tell clinical going if a the portion spend, in of think I take for us hold VITESSE look about When ramp-up you attributed should last place? we we and the with

Daniel Tassé

I to to don't question. turn additional Sébastien right I'll That's have answer an now. detail, that

of So clinical clear, be about, asking -- the you're first that Jonathan, you're in what to the and asking Sébastien spend is X months, much our correct?

Jonathan Wolleben

proxy the it's Yes, kind of have. we

Operator

open. line's your Sébastien,

Daniel Tassé

in can with is that say are our we I reiterating looking for results. the cash Sébastien ether quarterly that we're guidance last what While we gave

our we're how So although a setback there's we're money. attentive initiation, obviously to spending

So translate to time. guidance Guidance we in -- point as time. this in that our need can you I no revise to -- point this see at our at said, guideline

Operator

And our from Clément Bassat. comes next question

Clément Bassat

you post dose this Bassat comment more method the constitution linked Portzamparc. categorization the is about children of concern analysis have to Clément of trade. X to it the FDA or according question about the release. group regarding is It from please I is of press of the provide a about previous color data, which reactive the Could your of the data.

Daniel Tassé

use of Pharis? I'll nothing with the they a Is end The Pharis adverse want assessment give to do the the analysis point question. to the a for buckets that is It's good you events. answer. of of But let correct, has categorizing VITESSE. primary fact it's

Pharis Mohideen

Yes, that's correct. It's what related basically to rows counting just Daniel mentioned.

Clément Bassat

Okay.

is first point. So the that

Daniel Tassé

improperly. repeat Clément, We've can you you I'm that? answered sorry,

Clément Bassat

All right.

the of constitution the about the data? group is it categorization So of children,

Daniel Tassé

to get Yes, does of categorized, specific. children be experiencing groups specific of it events, be adverse to how

Operator

Our next Jacob Kempen. comes from question from Mekhael

Jacob Mekhael

I'm maybe far just have the the that has been tell just issues. and issues And to can elaborate please curious progress be us you what if made hold resolved what been so resolved? remain on on issues

Daniel Tassé

exchanges we've with interactions, plan theirs. point understanding as we in progress point FDA don't those provide at at on to the our look, more And I Yes, and details time, time, which productive. the to this in good any. obviously, this exchanges wish had protocol, to lifted, wholesome outcome the they've the changes and hold in Once any the of why is to if timeline, be on said, been describing quite impact our and is the

at worse I have finalized and a clinical the anything inconclusive, not very be yet with list the clinical productive we then, is okay relationship have hold been we hold. has best with in at FDA been to we counterproductive the until But now could that of believe the that. will say what addressing be

Operator

our HC Matthew Caufield And Wainwright. comes question next from from

Matthew Caufield

then follow-up and X question. quick X clarification Just

correct? the the adverse adverse being events speaking There's previous the categorization about is no whatsoever to events? about one the itself the It's of of clarifications, saying all you're hold relationship So categorized. just of patch, the

Daniel Tassé

study the of specific of adverse the specific. It's the with if to comments. X of answers That analysis that is was comment the not question. That your categorization by the patch, that It's events. one

Matthew Caufield

Just some September. quickly of trial X uncommon missed? And taking Is September just happen of taken Any the could. week clinical of last helpful. any place Or the for first quick miscommunication so XX, thoughts hold Was to question, initiation? turnaround the something sort curious with that's the had then agency? just the there kind that after that was of following if there. initiation thoughts No, on place Yes. of somehow that trial on I sort

Daniel Tassé

surprised Yes, with with hold. I'll were share you we our thoughts. the clinical

a discussion issue safety unless with to case company. not That patients, know, have usually, the the you the As that's would a here, agency there's okay. was

not to to before to we Given be now protocol issues afterwards start is most trial execute the and we initiate And to part comes so agency we the do modify evaluating of as review enrolling duly terribly if a discuss data the the they process patients, time did matter I'll at it when the product. program the than rather comes costly to it the the here. And decided here. discussion them when helpful ability would that hold, come need the before giving

that we to it the So something to it's not it's help is when think and program the fact common, agency enrich going we is were although assessment. comes us helping surprised the

Operator

from question next Our comes Arsene Guekam.

Arsene Guekam

may. Three questions, if I

me? do question on you Another hello, -- hear

Daniel Tassé

hello. We yes, can,

Arsene Guekam

Yes.

Okay.

Sorry.

you between give the event? number the Okay. what understand and us patients sure well this meaning color this? And adverse is of the higher first to on not meaning question. what for is the a categorization This Could link I'm trial? needed of of your more the

think there you this when cash give for your FDA this any And is, the feedback do situation... last will one, you impact one clinical The a hold trial? that burn on of second lifted on the Is

Daniel Tassé

one. Three first one, the burn good I'll and questions. Pharis the cash I'll have take answer and second

So can share, adverse event you wish if the detail any categorization. share, on Pharis, more to you

Pharis Mohideen

just It's us not simple as them bucket wanted we as categorized occurred. really bucket. how the to simply types of We're FDA Yes. events. different collect It's that. It's how the they wanted that events adverse changing them one in or

a We should bucket. thought be different this in

And there as was so it and but that. if as different the that it. between question was X issues. really no was of simple that there And number subjects, don't that answers your are link sufficiently, know I

Arsene Guekam

the I increase But Phase for Okay. I asked FDA if number the to if of understand patients may, you well, III... our

Pharis Mohideen

but adverse events. it -- It not to did, power to to to the up -- was was related identify be it's able this not better

events trials to there wish not though, on database, efficacy. have power And the the they're agency actually, -- -- But between it's not adverse know, you this efficacy. classified. safety, categories, more the to As patients In are clarified buckets no patients. the to which be and wanted the powered powered enrich linkage case, up will more was on safety

Daniel Tassé

the about one. let Your burn. question me Arsene, the With my forgot apologies but And here, one. second third I third cash answer

Arsene Guekam

when feedback give hold, the you the of you the from will do that And FDA think the feedback? lift

Daniel Tassé

it FDA's address hold pretty again. regs responded comments to elements clear. to to has then to either and starts days over lift what XX comments, are the is agency provide on us, going X or it, clinical of The then the the the the hold. is sponsor to clock supplemental Once all the to Well, respond the the DBV clinical clock on respond we've we're

agency, has the we'll when not agency they respond and cash, delay on us said, to obviously, to that. this we time. so will get we've To XX made satisfied But I more committing burn, the as we than had study. have days. to that announced with we We're exchanges progress the point time. in we're years. once agency, have So obviously, all bring to close months, of productive, been -- to of the That completion the more X the said, respond at consume impact the there. The cash for to we That's long a being cash XX

at to best treasury good a $XXX million. cash. pull, obviously, have There's We can we some levers preserve

an cash this the impact, burn, at will does obviously, that change at our we've not the it have guidance So it given time, the on end QX. fact despite in of point

Operator

back more at no speakers have comments. I'll this time. we questions to final And turn the for it

Daniel Tassé

to I evening. you everybody today wish just great Thank wish always, thank you your availability for for you always available for questions. we're as discussions and all, so. want if and to your a do And follow-up

Operator

Ladies you. today's conference. this Thank for Thank participating. and you gentlemen, concludes

now You may disconnect.

DBV Technologies (DBVT) 3 Nov 222022 Q3 Earnings call transcript