Otonomy (OTIC) 11 Nov 212021 Q3 Earnings call transcript

Good day, everyone, and thank you for standing by. Welcome to the Otonomy Third Quarter 2021 Financial Results and Corporate Update Call. 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, today's conference is being recorded. now today, hand President, Contessa at would to conference Investor I Westwicke. speaker your Semaan, Instructions] like the to over Relations [Operator the Vice ahead. go Please

and third Good XXXX afternoon, to conference Otonomy's and financial welcome results business update call. quarter

Otonomy call and Officer; Cayer, Joining Paul David and Financial Executive Dr. from on Weber, are me Business and Chief the President Chief Officer.

the expectations. that over today's Such information the of required from to Otonomy's would refer will obligation like based except you that with the filings call available Before as which by affect include and the I on represent could to of CEO I could differ SEC, Please statements, I are Weber, to President specifically may website and on update statements Weber, risk concerning Otonomy actual disclaims current factors turn management's from as and law. judgment Otonomy. Company. involve or call Dave materially to Dr. results the to results. the Otonomy uncertainties SEC statements will forward-looking any call cause over forward-looking to today turn expected any remind that for risks now the

thank you call you, Good everyone, updates third of XXXX. joining our the quarter afternoon, Thank discuss financial us on as Contessa. this Otonomy's well for and to as business recent results for

top momentum in Phase quarter's track, our strong our clinical the line for X ongoing the on tinnitus continued in as for in mid-XXXX. is are are and update this have follows: results reiterating the takeaways trial We for guidance trials and we Enrollment key OTO-XXX

in loss in top results line now OTO-XXX actually of ahead are of We quarter second expect the for enrolling and the XXXX. Phase cohort Xa hearing schedule early

in efficacy Phase activities OTO-XXX, the I loss enrollment evaluation dose by support is minute, expect clinical in order discuss in to higher to necessary a have testing overall report in initiate for the our to Xa dosing for complete to the we XXXX. safety next initiate X this am higher more the hearing cohort but month. a plan trial Phase and OTO-XXX of Additionally, and completed I'll that to of dose-ranging end pleased patients full

OTO-XXX program, we and our still are and gene of to loss. to in two half activities an other IND-enabling protection We're IND preclinical for first Regarding OTO-XXX therapy also the ongoing, programs, progress OTO-XXX file expect XXXX. our auto severe for hearing continuing

of Company financial current for we second the are that half with our into expect and Finally, on XXXX. XXXX fund will guidance track the our cash

to a During and programs line the open and on update OTO-XXX The moderate based the of placebo XXX the or injection or randomized Tinnitus versus a trial with tinnitus this I'll for a X/X the Phase on the in severity the going design four followed can demonstrated group responders our at based this X approximately enroll single TFI. higher proportion Patients The Phase OTO-XXX well. Beginning Index, trial trial is call, X provide is in of patients brief OTO-XXX, months. unilateral intratympanic Phase trial on for and then with of results, that questions. least on will enrollment successful based are up financial placebo persistent Functional we of TFI.

Phase enriched patients and severe have required for at on we excluding month the both X/X As response we trial, the primary in study by population entry the minimum use TFI Based trial, and profound for the hearing loss. with Phase or efficacy. X/X the TFI two one increasing will score month

top tinnitus year. and line is from to and track onset is also up on Europe, maximum We population enrollment increasing by one months expanded to mid-XXXX. U.S. enrolling eligible the the trial for from The patient across results six in time

of OTO-XXX otolaryngology publication neurotology, field. announced results the a in journal X/X recently the otology Phase trial leading also in peer-reviewed and We

we previously additional results supportive publication in material detail. communications, includes our the public disclosed the have While

visualize For clear separation baseline is two placebo. the data for interference, potential month highlights from OTO-XXX. of of to status multiple reported to example, sleep for sense The quality control, easy auditory in the subscales, demonstrating benefit versus radar presented plots including eight intrusiveness, for emotional OTO-XXX change by are the disturbance, This function, of subscales patients TFI and improvement in improvement life. of the cognitive broad-based treatment

program treatment in improve is growing due the hearing which using speech an to damage to brain-derived tests. the hair population cells. is cochlea of stage factor, connections Our By highly evidence spotting broad of which formulation earlier next neuronal induce promote loss [audio and body relevant approach functional inner occurs hear exposure gap] endogenous based can loss we synapses, OTO-XXX is noise neurotrophic is or fibers demonstrated sustained of This than that cell of ear growth and hearing, therapeutic OTO-XXX, reconnection a aging BDNF, the to the indicating clinical nerve for a factor. on or these noise auditory can the neurite nerve hearing believe cochlear repairing that

that of ascending of gap] for Following weeks. Xa in enrollment receive few will cohort parallel of all XXXX. XX for test test, Phase approximately [audio dosing. hearing X/X American tolerated, of patients schedule, Enrollment is of expansion ahead patients expected English trial, line XX intratympanic results tests Because Phase single the early cohorts. will Freight the evaluated higher will hearing expect OTO-XXX and test. top initiated we the doses tested months an in highest cohort working Patients the a we quarter validated now to Phase three noise injection a placebo. dose evaluation complete speech and used double-blind, loss and we Xa placebo-controlled initial the This cohort milligrams randomized, and dose the in the to be is is Xa second well in the of prior Digits-in-Noise the have Words-in-Noise enable study X.X evaluated. XX in and the receive next The Phase followed enrollment with positive been OTO-XXX Matrix were

dose want in push completed the that of to pleased and activities, always sharing initiate safe highest we a the developer, of we a including so higher dose that FDA month. next to cohort can I the the necessary enrollment As with information I'm

a evaluation, full X We potential safety will and the loss we initiate market opportunity. trial along Xa move from enroll in higher end program to up Phase address by cohort. to a with continues the XX or least dose-ranging results dose higher efficacy placebo Phase patients This patients at safety of on hearing well loss X:X and XXXX. the OTO-XXX cohort dose hearing will to one multibillion-dollar Then based randomized to

cause gene Our OTO-XXX, ears that is of identified program is third a with have congenital is targeting hearing born mutation the Patients loss. severe to in can most in GJBX, common this which profound both proof-of-concept representing screening therapy newborns. two Preclinical severity for that single now range a in by performed demonstrate routinely cochlear tests a damage GJBX OTO-XXX preclinical loss of in results administration deficiency. OTO-XXX of models hearing and deafness rescues

We and half are study an clinical file into These to manufacturing the IND-enabling have XXXX. feedback design, meeting first incorporated ongoing, that considerations have in IND activities nonclinical guidance provided regarding FDA program. our completed this trial the requirements, we and of with and a expect pre-IND

with at for continues cell hair Our programs. XXX, hearing patients and risk cisplatin-induced which repair financials. hearing remaining targets regeneration loss two to loss. both Switching of programs for otoprotectant for Preclinical are or these briefly on patients severe OTO-XXX and development our

Phase third for in operating The are exclusion the is cash totaling reported adjustment We cash medical Xa a which represent with higher cash are to X of the we evaluate with quarter unmet of clinical Company of is and balance and to perspective, continue expenses large that this in balance, for our operating XXXX. In of hearing expenses million. including able non-GAAP non-GAAP quarter cash, making the at GAAP guidance we equivalents programs on treating compensation $XX.X fund be expenses well, are Phase short-term to OTO-XXX. relief. untapped the OTO-XXX going and our good And advancing we excited in half of of the We track dosing million multiple for significant today's investments need. and a provided cash the tinnitus, million. will XXXX summary, the stock-based enrollment and progress XXXX. we OTO-XXX finished the Patient with third loss with $XX.X into reconciliation end expect From $XX.X markets for

hearing and loss company Additionally, patient the targeting congenital to we deficiency, only a therapy gene present GJBX for population. are largest the results first proof-of-concept preclinical

into guidance from the those this move ongoing. what have IND-enabling gap] [audio program clinical development clear FDA to is required activities We and on

quarters. the our Operator, multiple and questions. Our are we balance successfully milestones, the next are in sheet few we fully ready strong, program now readouts have clinical including for achieving focused we is on

Ken first go Cacciatore And of Cowen. from Instructions] question [Operator our now Please ahead. comes

want kind gave on And for meaningful await like it to we to description good all then set implications able the as those be a of of on of Obviously, what a can improvement? though, progress. kind expecting from Congratulations you one really enrollment. months threshold Dave, you be of a six you just sounds results? the of should Can TFI. talk And us clinically just maybe the pace quicken bit little we you expanding about to help year. wondering, good

implications how to Obviously, and bit of of heterogenicity the that maybe a a talk a that? doing And that ensuring little that want? loss, little XXX, give you then enrollment for of You would the about the you're little though can kind got about you hearing to and talk population get of the bit lot we a patient criteria? on have screening some bit to

clinical I'm continue Thank in to very we Ken. Sure, milestones Thank basis. make that the on you. with a achieving delighted progress our you. reliable

and about talk let's the XXX first TFI. So

for XX-point a developers meaningful of meaningful change that of a clinically the So change. And requirement what greater XX-point severity. we that measuring our identified for change. what level And TFI instrument as or as improvement the clinical is a in clinically is is use the validated validation, tinnitus establishing clinically

TFI eight to XXX XX possible add little there. points. background a The that Now There are has subscales. up questions

And here the in so for in looking number the reduction -- is what score. we're

And XX-point greater or changed. so that

of single we also what even use Most will mention here reverting effect reason of really changing points. effect. I we are in believe is actually trials on the But the think a this and based being we doing for Now I looking important. really are what is even terms so, is more, say And we've in actually I our time we're increased that clinical that And biology multiple is prolonged tinnitus. endpoint. us hurdle of

both at clinically in saw improving our to we one that's know, Phase two. month month meaningful achieving you something trial clinically meaningful level and both of improvements saw achieve that have and one X/X we month patients As two improvement. And we and use

And so that that's X. really primary our as will the we our use analysis in Phase responder

In on addition, in which which the we as will measures, to Phase done the improvement showed scale as change trial, annoyance Phase a TFI X/X. daily the continue that and well to all the results global X of patient consistent impression have in loudness are

terms very efficacy of outcome So we're clear in our for. that looking primary

of up the homogeneous extending could. to make terms on go you months that one we year, a X. from now Phase onset of profile really tinnitus clearly, patient a as to In proof of into based population since Phase six X/X concept, as really With we want was

showed reason both up patients which homogeneous now and month a population. least XX-point six the favorable a the at we or change one months was that on at those very so greater create improved. needed corporate that we to that two, felt a we had present the of And that XX% patients. type the Based partially really longer-term results, we the to our And website, look deck really we that longer to was have showed quite duration in based dramatically fact, that's patients that data had on available on improved, in data at where for

one And that's what of -- increase so therefore up one the the to impetus year. drove to

that duration are for up as clearly, months year. in patients that will two likely with to months months it believe six months longer But favorably We stratifying patients respond and one than six longer six from we that up to well. are the is

while taking still to expand we're step-wise our to showing the So with look approach at capability steps that of a patient population in having improvement. development wider

the in the are physician, now complain to to when ability which talking first they Again, So the there. to OTO-XXX let's in most enrollment the improvements company criteria identifying about on focused environments. really other turn we hear noisy patients the is be people to what in daily environments, are which appear

that What the level perception. we that and speech patients on Digits-in-Noise. call the DIN and as And test so we they certain tests. for speech the noise minimum are tests these speech have We're to noise using it, we to Digit-in-Noise a call what are require test have

minimum As threshold and test our want based criterion, with level to that work of speech on KOLs to we the this establish was for. hearing noise

of assess and they profound to also patients can loss hearing up on normal can so changes to severe profound audiometry, show so We these patients they they of up audiometry show their be -- in loss. either terms hearing have can to or but hearing no audiometry moderate have loss, cannot on

And is as part criteria so well. that of our

And our ahead Charles please. Duncan next from Go question from Fitzgerald. is Cantor

on Or Dave. program, time on the I in then stratifying regard etiology? are that symptom I'm interested to time Are down? kind guess in Congrats six-month less information hard is the XXX or for sense questions. Thanks now, also that harder tinnitus taking for would to Primarily nail symptom our onset. X- progress. collecting And wondering, you addition sense to versus XX-month to you onset, with secondarily, anticipate that patients to treat of patients? really to difficult right two-

right. Thanks, Charles. All

with So onset first to etiology. let's regards in the the talk

we So etiology. tracking are

event ask -- for we patients we looking in an the we tentative. -- resulted the that are So collecting are

if the can That back point oriented a was they to for cochlear onset. the So event. trigger

on And what information study. meeting terms the in to benefit in is study X might at also based collecting others. we this less that patients looking that both Phase are information. be to understand data helps than more etiology of criteria It the But scale we're for or obviously, larger then going so that

is looking So, onset at to time question are we and With That we information the not collecting since that. to are the whether there is or that more regards trying and maybe answer. response.

effect Now, step -- a important, is tinnitus reason if right back, we is persistent now. the that that let's is this

from to reverse decades. for some origin a KOL based know for us vary cochlear of point, we none may of patients, years, think time to a that tinnitus an where longer because to more What patients so, the is? on treatment there's reversible. look be being never Will it there at tinnitus And it's it And in as can is belief assess But effective you have moves at what that important no really note where been can I field and problem. that talk to. centralized a frame you

see X/X that well. six had the things One patients is up to in duration that Phase of that I the was of to longer the pleased end the very months responded

Most peripheral. months. up we study. now why evaluate is a so longer in XX we're XX likely the it's we and that to do up body collect still there as biologist, we months, that would a which in that's And going look for what didn't to than clock is that's the us extend And that time year, very think is that that's looking still I to had we're patients XX And patients. one longer and were KOLs in comfortable And particular this And up that just the to in made based stratification shift. I on precise that what believe improvement is dramatic to a things What it push at see. improvement don't the further seeing what X/X that for determine duration duration further information, fact, Phase at in point months. agree

our we careful as But clearly, steps that XX development. kind be that see we're longer. than that impetus taking if have look Now in even even further product it to of would better as months, long patients getting that's

sense. makes That Okay.

Yes, small that larger? which could next unilateral to Or I'd are for let's of But study, to a this the imagine readout, studies a first the need N=XXX? it's much secondarily, of is like multiple do trial future? plan there the I this next deal bilateral Let in in study. about forward of couple how size that one clear terms tinnitus could of to then moving steps. with sign you assume study be think talk a let's for justify me versus -- results And be in up know that the you

let's So here. stepwise that take

Well, results, be with and a Phase having X would steps. be regards our we'd to with then end to the meeting of clearly, So next first, FDA steps? with positive what talk the next meeting about

do that I registration think, will I expect the require FDA two trials.

I think that. on can do the on dependent X from size power that calculations and the of be we those the we will what see based Phase

will on the saw it should having obviously, us power help to we X/X, Phase be with that to from in in to think So the our data large what population calculations we do X extremely these we that base clearly, more what be will that have But studies. look Phase like. not getting determine

the X the approach size go trials into would So registration and that power trials with Phase see X we data. be would is to there our on the using registration based that

roughly. think I patients from there eager in to patients. a bilateral, of doing well suffering trials. look we how -- clearly, we are are that it's we very shows, they recognize bilateral patients lot there And terms clinical rolling obviously are out patients bilateral. there clearly, about and in XX-XX and be There's at are of our as But unilateral enrollment in

diseases. importantly and They important realize us -- unilateral are for to that tinnitus. it's are think not I bilateral different

it And so tentative it was that got in origin of ears. both means of biology cocoa origin either that their such the or the patient just through they

approach and treatment that So OTO-XXX whether be tinnitus, unilateral it bilateral. what our the is as developing it's would to are here we of approach for is

variability. reduce you a clinical population try in trials it's common very to create to know, homogeneous As to

unilateral. why, focused this is on point, at that So we're

unilateral used the to would in safety data safety. that support for having by for bilateral and the what then are bilateral preparing product patients However, evaluation be doing patients that both we in is to support

will also to think so very that's that that bilateral, that to would our the possible discussion something want we them. example, might Obviously, I we And FDA need But be to do that see single in be with with a if study for approach. have it. a is it required have we that discussions

importantly, to is both it and develop we treatment think the most is but lateral the data is what the bilateral to is a for important efficacy I that tinnitus. that support safety think support to utilize effective unilateral

François ahead, from Brisebois next go [Operator question Instructions] is from Please Oppenheimer. Our sir.

Just a couple here.

So ahead with that Is while -- the pandemic. I being schedule, is you a of little any you there the haven't ahead color specific for what give of expected? heard any in XXX on a reason that can had

I think combination it's a of, François.

for you thank and being on here joining us. So

combination things it's these I is a that clearly, think here large of populations. are

here. what from clinically clear obviously supported by that's -- with of schedule is think and treatment of the for with These are indication I XXX of track XXX that high looking audience and recruitment. we're on being what at we populations, large need, ahead say we're a can unmet a high size the seeing

I to doing are and give study. Now our to team clinical credit working and qualification in have the also investigators job screening I and who staff a of say our fantastic and to site enrollment think that, through patients

times not of in obviously, easy. So COVID, it's

emphasizes it's different is give these done but for a tremendous therapy. example. have as looking with we OTO-XXX But challenges do there's as looking populations for lots and that. and who an talk interest effective of because a number you unmet almost in job. are much to tinnitus. I'll foremost, I know, outreach experiencing trial are team is of so the need of treatment. think never knows we patients our I the everyone seen And someone that the clinical As It first dramatically have or the size number who patients very has of by of there,

and job that, with who site and think motivated. and investigators, of our I and highly So then foremost, by incredible an are people, all first working CRO the all teams staff patients

a to you're just if the you this, But talked it how remind find just did. patient know about don't And little potentially? to unilateral but is always -- us you how a know the I apologize in tinnitus breakdown it mentioned -- in population, if ear -- of bilateral? is easy how something that's lot hard so it but the And in Great. Okay. starts progresses? I a one population, unnatural versus huge has -- I often bit, versus or what's dosed if I And you're also as -- in ultimately, and is that and there you unilateral is differently know a be bilateral, if bilateral? the trial

it No, to XX-XX being clearly, about to very XX-XX XX-XX. pretty close that it's say to exact, but down won't of is bilateral. unilateral I breaks

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patients it -- are we and So but taking something is that we that identify as really being unilateral assess.

the So of -- but people the subjective the when XX-XX. roughly U.S. to tinnitus, million breakdown -- you there's look landscape, of at are in million alone, look was And tinnitus if X moderate severe. which is XX at U.S. we

So then break there it XX-XX. you from can

talking X large each in those are obviously million X enrollment. other very basically bilateral. You're which And individually and million are each clearly, reflected unilateral is our -- population, that are

go sorry, -- can I if then ahead. And

No, go fine. ahead. That's

also was like lot mentioned to variability It going a lot peripheral when from last just a can of switch would the seems central it But that happen? of from for on here possible And that when your disagree one patients Okay. to between there's center peripheral tinnitus happens. just that KOLs on on is you central.

where developing to this know to think I that. that And allow say this will effective I have biologist, Well, an therapy point evaluate here happens really at we a in us time, here. what is don't as

I to be diverse. expect populations think I

characterized look for could a the treated driven. that think at may And with this couldn't of would one who what be expect is I not degree. whether prolonged is have have affected is large have Maybe still be So peripheral tinnitus that and and still or it. may to period also by central it that there patients I things peripherally who are tinnitus really as we patients

look think for matter are comers, time, had are have a at looking further we a it's But rather people who've again, at period XXX look to -- all with and I So take able longer gradually of out. term. we of this very a until long than for Clearly, tentative work do works recognize and of it if a them had to we there's be there we have period will patients It'd prolonged it's number going but of for out something tremendous wonderful XXX that time. approach stepwise. tenants

and a at expand I demonstrate occur, there's development look and there. is peripheral a years do years, to more in transition we move data that from that we opinion. say do and really have see define, a two clearly And look has what when It one think one Let's year, three continued really you at populations can No activity it with of among I just from exactly KOLs that. central. clearly can homogeneous that's whether the patient effect population that where careful that, of then No to out points knows. biologist, XXX. differences really we is to at will an as that

H.C. And Oren from coming Livnat go Wainwright. is Please ahead. our question from next

two groups but indulge going do a I I such Are on you And primary follow-up. a dance have a have worse points? questions, observation, different not to will the have might people think stratified are remind by longer you even On trends have you're and bit, X be is getting decent X, you set. little onset months can likely that to I few And case I wanes if -- confident a different And that have chance better, you that me. Phase on statistical enough six no getting that the to four you three the enough you or comfortable saw efficacy time us what sacrifice patients power expanding? going it's in you're have you this just there that in Phase if people the that a efficacy to from overall it but how in months XXX, is on then small, time you it's for the expect extended idea? significance know

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powering based X/X, limited on So Phase we are a obviously. set the data from

the more that what So, will of doing to that's we is accurately -- to powering part registration X us really the define and be. then those must a of trial Phase data size why allow program we're get trials

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the primary Our from will and four, month or not at that of two. inform patients are remain from whether and three improve these single month But to we and standpoint us at continue looking endpoint a looking will one administration.

be We benefit see about able to we in not patients clearly, the or potential which future. whether assess that before we will for is would longer look at the But that means haven't retreatment need even retreatment longer necessary. even we the go to talked that

as of just these patients some And you going to from remind actually severe I'll well, mild. we're

there's a particularly treatment improve to if month further they whether So of need even even beyond two. question and continue that they to

this, X of think, population the part to into of trials. to continue trial important we learnings to all decisions very be from going then progress patient I Phase will allow So registration informed with that make this larger is an as us our

take coming to being I'm of a like this just you excluding taking Okay. said, but something I could from and huge generally an population, of the only, mentioned If conduct, criticize, study I schedule. And all-comers sounds coin, like guess, side population, hearing not obviously, is on a loss. profound you're ahead ignorance that it OTO-XXX you place other of like

in So get a study one I'd or days in to patients weeks, cohort. months, could recruit if not the imagine theory, XX into

really for? profile just a to What is candidate extent you sort out? someone can good you just are we the are -- study? this you disclose, why can the guess, not and about I of really can for how So patients patient talk why? you screening How looking

of the are hearing their in we Obviously, loss. that at terms nature looking patient of Yes.

something injury of example exclude that like for So be would we exclude. brain example, traumatic we things an

that's into there things are expect a I'm example said, be brain loss there you I criteria would that to that traumatic of But types small recover. the but there one of hearing there not around, go is relatively not Like injury. for the to going So may exclusion population. list a things, exclusions

and The to for where we difficulty. perception using and this patients their test be speech think, really the screen noise other effective would at is very is the patients, these initial looking DIN, Digits-in-Noise

is -- you patients coming reason that are patients. large do self-reported. They're in of about already have number problem. of Now the this These that a are part complaining the

to hear sites majority it's needing and in hearing out And patient what bit these that I when that are background come it's patients, in back them So have to say or patients a in them. They talking. people complaining about their to think they important there the going in, because these start these Well, the other ability come it's have patients not noise, from? clinical loss, if already these files. up I come where of they're it's seen patients are and do recruit

whether clinicians fix analyze structural and that would surgery, will or that they try something of will what injury to damage going not the the patient they if help some or hearing determine if Now patient they do or kind by other is has there's on. else

the aging Now just It's loss. not for what hearing exposure majority that's typically case. result the know, patients, noise and in we of

potential hearing in, patients are coming audiologist referred they're already presenting in many to these so cases, already they're aids. for and And already being the

pool. population reason and well our it, can the of obviously, den already see have sites then, and as there that with patients screen we in that's that have so do to a patient able it's a pool they test What as work then clinical the And look qualify. go against large to having is these patients at we and based if on criteria the they been do

to in able already identified difficulty helps we piece are complaining And as an already that of we're way clearly side. that important and is patients enrollment are and speech These not this go are go that's on the noise and population we're about the having to So hearing it. they're approach why advertise. out that because having I think

you Or of of based response the us, duration a the action have Okay. higher because I Is already at higher it indication should along some on remind dose way? your can the And maybe seen the higher just just that you formulation? formulation, doses. And you have somewhere longer site just it's given does mean going dose, your on a because can safe?

Yes.

me is It's randomized so that no first Xa blinded access at Phase we have study, data blinded. of let to be any a looked the all, data. from we've not clear, So

on based effects very the if as did is this saw patients on placebo. fact, it, about So safety fewer the just a I the remind better and people OTO-XXX adverse actually have actually on we than patients developer, showed data in clean,

just based And tolerated. then a things we clean in XX-fold there. we a other was also back, obviously, so very on range did our a And profile remind large of well range dose very safety dose. people, I'll did looking

So develop if and broad we data go we different probably that tested it's felt a four we very that range, a capability higher additional across could information. we doses but strong

very to that that we're higher of well at if efficacy concept, by least dose, those given dose, look the of we And one with Clearly, XX% and so in want highest We seeing XX% on decided tests in improved single very, that based you administration. the we tolerated tests what the that if we that's three and speech happy though noise it's did. we're at. patients something least can proof at on of at even a of recall, go two

we work. ranging And into We look why with go going Phase ready We a is do at the to full would that that that then and a study. are to that and say be back. FDA to now study took can escalation. we'll that then be dose stepped safety now so we happy did into And dose additional X

ahead, would Weber. this over Dr. I'm And further questions go point, Please on not to you. showing any like back the it Thank Weber. I Dave to Dr. At queue. turn

Well, thank we participating everyone. the with today, meet of evening, Conference. you, good many everyone, our at Piper Sandler and you a call Have to hope for upcoming in Healthcare

And conference your for everyone, concludes you, today's participation. this Thank call.

Have great You now disconnect. all a day. may