DBV Technologies (DBVT) 30 Jul 242024 Q2 Earnings call transcript

Welcome to the DBV Second Quarter Financial Results and Business Update Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Katie Matthews, Investor Relations. Please go ahead.

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 3 and 6 months ended June 30th, 2024. available website. press is the section release Technologies DBV press in releases the of This

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

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

Executive and Dr. call Officer the Officer. I Joining me Virginie Daniel. now Financial DBV; Chief Chief Medical today to Daniel? on our will of Tasse, over call Mohideen, Daniel Boucinha, DBV's the Pharis are Chief Officer; pass

first XXXX DBV's call thank joining financial second results. and for quarter Katie, our you, this evening Thank everyone, to review half and you,

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toddlers in of program other our to to Turning age. years X X

let first that with existing EPITOPE. And recognize but of that state, to to once we And importance preparation our last XXth. from COMFORT FDA user efficacy Medicine pivotal resides was be of III in year. awaiting Phase answer a we Journal alignment. and the trial, endpoint of advance study which from which agency June England me right in more recall with on treatment, data met the as published increase to in response and number the supportive X-year-old about wear COMFORT proposal, FDA day-to-day able wear safety study, in days has in results that Officer, COMFORT the FDA that EPITOPE, submitted treatment bit informed and the agency FDA that we question, queries on known the proposal, a we the focused an ongoing including we to a our X we the to the during I experience, firstly, the the and study, to pivotal moment of subjects of result here, dialog for so have the of analysis comprehensive New protocol proposal, study support the advise EPITOPE about successful announced the requested FDA have on believe to that question in we that engaged in are then, study caregivers dialog us in Medical last a clearly protocol details in by will analyses agency's how primary BLA. We call patch time. responded the labeling and which let mainly a first asked study patch the alignment recently focused on this experience in Pharis, the X- the details to into to labeling treatment, supplemental of seek with Toddlers conduct more address initiate we time. or would we FDA, Toddlers variability months Toddlers, of Also submitted manage November time that on of supplemental safety Chief recall its have year, we and safety to provided wear while patch draft prescribers effort Since March. to Let's activities the data, XX parents were the agency to the database that and continue regarding The we get

Finally, programs. point, detailed third of on continued runway measures. turn more shortly. At XXXX, cost-saving would have the is the our details like on Virginie, result Medical our over Pharis? I we update that, Chief that cash our for our and to this give Mohideen, let will into Through extended I QX of the Officer, CFO, Pharis to a Dr. update clinical more call

Thank you, Daniel.

tests. First, let's with the start

a the study Peanut patch. you XXX-patient Viaskin this X- with to is in X-year-olds allergy using If recall, modified peanut

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For participants, academic contributions. patient diligent their have the to support example, also our they really advocacy our the conferences. never are and at engage and multiple tremendous small study must staff fail but parents, incredibly our medical our medical affairs in and their received team do the And from we for societies. I we caregivers, stakeholders subjects job, appreciate and groups is thank the that and fantastic investigators a course, numbers, of

to of the press As close recruitment the line months we release, quarter top third end after year. that follow We anticipate by we said results is the approximately of the last this would patient XX in estimate screened.

along provide detailed the We way. updates will more certainly

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protocol wear-time the submitted been the and largely experience, protocol and agency's agency year. patch approach focused DBV toddler June FDA in to Following patch a variability with November On engaged prescribers parents submitted data would in patch then, to the including a related dialog. These The in responded safety FDA wear-time comprehensive how March wear-time. ongoing and DBV experience. supportive day-to-day Type on draft analyses Since to proposed intended with have of XXXX. concerns we C XX, in labeling comments to address caregivers manage exchanges this meeting, advise

this feedback We proposal. are the FDA's now labeling on waiting for

we Let FDA. the EPITOPE. explain agency's best are the answered believe, proposal we submitted to pivotal with questions, trial The me labeling from our that data the

in skin the dose characteristics the of Viaskin concept. identified and within still the X the peanut-specific with baseline are The arm. of label-out EPITOPE as give and can awaiting such discussion and the Based call prick immunological on agency subjects, of groups We Peanut subjects. test, groups label-out label-in treatment label-in eliciting similar. IgE, the are we feedback, data, I We analysis have but X an overview and the our you

patch So, drive in in is in press the in there allergen applied immune peanut is release. differences clearly the a sensitivity as wear-time experience. to the we what difference that physiology This locally refer to differences

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a are efficacy prescribing response The less response proposal of likely financial pragmatic, subjects label-out, this patch recommend days would the label-out, information are should Peanut that less Subjects information, shared All the discontinuation treatment guidance if and a first robust process and of give way that is the label-in. continue proposed label-in this cover be for indicates parents determine to treatment. to during and to invite robust that are discussed. subjects wear-time Viaskin recommend a discuss on would this would If label, between can XX believe be be Viaskin efficacy are patch these Virginie other healthcare provide point, very caregiver treatment. Alternatively, the subjects prescribing a or clinical efficacy as discontinued. experience done just wear-time with the we treatment the have on to provider proposed I'd identified called and likely likely Peanut proposed decision-making like and experience words, In prescribers have parent to label should to called caregivers. At to approved, is highlights. data-driven that

very you Pharis. Thank much,

runway now particular, there like review XXXX. first operating X highlights expense. in our are for P&L, cash briefly of financial So, we'll would our and And highlights the elaborate to on: semester I

consumption that until us is This we into runway hand, due XXXX, runway important takes quarter it's HX first largely is to sufficient and #X, HX totaled and But highlight So operations for cash clinical cash extension in cash first cash extension in we to consumption P&L. used of costs, our I includes ], elaborate and now million to have we where our that cash of implemented costs, measures communication which briefly our like as with $XX $XX.X to cash million, drive. There's consider activity. I will from study in as to HX was note an move million cost-saving closed prior such trials $XX of on ongoing XXXX. operations fund would startup year-end. COMFORT chain semester, now nonrecurring [ regulatory we financials CMC project of point In will continue of supply XXXX and the for another on terms activity.

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of semester, million. So, book this loss a $XX.X net for we

I'll I'd management. That that call cash our efficiency the back the maximize reiterate remarks. to turn concludes for remain the spend of So, to disciplined highly to closing financial continue and and we overview, in Daniel? like Daniel our

Virginie. you, Thank

Before year moment critical opening is for I the take for which call our for to would anticipated the of like remainder DBV. your recap to XXXX, questions, milestones a a

obviously X first, the the that of VITESSE age will III third and of that efficacy anticipate ongoing X quarter in end we communicate something age, once that's by years So, trial done. to Phase completing that's we our children enrollment reiterating in

solution proposed labeling analyses DBV's from backed EPITOPE. a that approach Secondly, and data is we believe with pragmatic robust

firsthand the successful III significant sharing having trial EPITOPE, all forward year that the that. And and improvements open results, We X. encouraged in more thank X bandwidth Q&A. I by obvious, open label regulatory to as sponsors. and we that with both for year them backlogs, wish we now, extension Recall XXth, the April joining X the everyone you I in the results products Viaskin with results year, such ask well have parameters responsibility the behind is last that add, phone were interaction as few to our within as year as of from that across are Peanut, and year ongoing now as known has and toddlers. will the Research division with for that OVRR, and Review, for CMC and journal. With Importantly, webcast desensitization months saw in this in later stated year look this our anticipate us would publication interactions further the a for which label X that for questions we in and ours, we're the to the Phase clinical-related so seeing Office agency And questions, Virginie of extension of on want efficacy our that, me well to the today. I medical it's agency non-COVID-related on Pharis the join later FDA is Vaccine as which the

come first will with JMP. Instructions] our from [Operator Citizens Jon Wolleben And question

Maybe just are have that. while I the experience, patch label-out, one the some X patch the concepts? experience interplay label-in, do wearing the long follow-ups clarification have or wear-time between you those wearing or how When quick on say then the patch, you kids an they and mean on

former. Important Other XX it easily more It's for question, Jonathan. a the patch asking. hours Yes. one Thanks other. day. wear kids fact some kids, it's day that No, the the to from the varies

nutshell. best is measured identify is patch in in be that a of put it? And to that way varies data the that's some a to wear So, patients. Pharis, good experience responders will wear-time hours in patients that rich

Yes, that's Daniel. good a way,

individual like adhesion in not, time. type it's like So, or it's variability have? I right? Jonathan, wear assessment, kind they think did way holistic a the just like Was experience what the itching, is of other about the lifestyle as it tolerability, The to Daniel patch it, difficult is that day-to-day but that experience, but It's not you to there it an of you sensitivity, There tease easy? of all element. And day-to-day time, daily some doesn't harder it's components look terms be wear just that's wear it story a may at not the always day or to long little but in variability. was out, one said, average tell in can the

some that So, to like product. more holistic gaps to fill think of of it the I of the help as there? Does a experience in with

to of a it number harder hours well, worn? quantify Yes, than does that make them, though, simple

of No, opposite. the not It's kind necessarily.

a all We we of our them. there's on that in different a clear so lot accumulated whole in, labeled have a And much can can't have characteristic on patients. there's that we patients, talk lot having. experience a out these this are that get data that to and those of data, based dataset patient's collect data, differentiation Obviously, you we quite good look of really who can can between the pretty of at we labeled trials a of good sense parameters. right? get of the But type And you pretty the with

it. Got

there's And you a a an Okay. if what robust efficacy you were wondering said label-in, based then of association clinical define patients response. some the around you between guys label-out EPITOPE robust parameters put on as what criteria? I'm this And could then percentage response.

want Pharis, you it or me want take it? to to take

can take it. I No,

I fashion. to the idea with have terms labeled discuss we'll in of and the dataset past point, FDA, a the of this numbers And until right know are this not pretty we're those still move in public So, well. good a point, the what vague. we probably between this it's in it labeled seen that's EPITOPE this as and because really versus final in dialog out. probably at FDA obviously, we know throw to best those forward, who of have we are the results. terms separation you've the But the the not agreement present But it. it's size But details. robust numbers specific of X And down, time at with wrestled all from in in this out really, is

overall Jonathan, if have rate. a we reference point, XX% here, may, I add would I As response

definition. obviously, to traditional label-ins a that, to a agency. quantification at agreement, with would in will So, here. we by come rate strategy point we better come response It's details enrichment the that down the If to the can the the have But agreement than will shared be come time. that

Got on it. And last Children. one one Update for me. COMFORT

think issues and Wondering timing seem. any you with have are expectations guys You there, different FDA feedback there Toddlers don't progress COMFORT do there? Children, feedback with for any would doesn't COMFORT from help or it

one, that take I'll Pharis. Yes,

Okay.

design to in an ability protocol element, The obviously, Children. intertwined. The X to get was right of COMFORT toddlers COMFORT are the for

we as agency, but discussions olds. to to job come will Children solve the with is to year next agreement wanted one So, X get for next our first. to year in the step toddlers in X

And Mr. [Operator no Instructions] further to appears Tasse, it I'll there turn back the you. conference questions. are

afternoon. Well, call I'm not Again, thank not. I'm that concludes our for mute? you. this on

the half look the pleased progress are and of milestones that next. forward We with first value-creating the year. achievement I described our in this We to additional of year

we a on keep I posted good progress, wish you you our all always, As evening. very and will

conference today's you attending. concludes call. this And Thank for