Otonomy (OTIC) 1 Mar 222021 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Q4 2021 Otonomy, Inc. Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]. to conference like speaker to now Mr. today, would hand over the your I Uhl. Robert you. Thank ahead. go Please

Good afternoon call. to results and welcome and XXXX and business financial full-year update conference Otonomy's fourth quarter

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

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

Good thank joining on recent and full you call everyone. you, us financial Otonomy's afternoon, well business to the for discuss as as fourth quarter Thank this updates, our Robert. for And results year.

ahead mid-XXXX. enrollment X two up expected announced We with have completed for Key as all continued largest in to the be XXXX top-line goals, set update unmet week, year this to we in our a trial of multiple we significant OTO-XXX has in against results need. with patient are neurotology, points for execute from readouts of well market which the takeaways medical schedule of time clinical Phase last in development each opportunities tinnitus as have follows;

of and XXXX. in than top We Xa quarter enrolled in the to line results early also the planned hearing loss OTO-XXX for the up second moved cohort fully earlier Phase timing

steps we are for higher clinical of of next for dosing include and the this this dose-ranging initiating bilateral program initiated Additionally, for of these year, The and trial believe full the will the studies dosing programs. expansive our for of XXXX. initiating have inform efficacy for X by OTO-XXX. from end evaluation OTO-XXX safety and Phase initiating data Phase first clinical and support OTO-XXX in both evaluation OTO-XXX higher half of We X set a

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

to of our multiple half and through continue sheet readouts remains that the our Finally, strong, clinical balance expect fund these will XXXX. company we cash second the into current and

line and completed enrollment During this financial for then intratympanic tinnitus the Patients patients. schedule. of least randomized Phase persistent with of placebo, severity, to X were moderate or randomized being trial one-to-one was are enrollment XXX our unilateral milligram of ahead a patients target XXX of above We which single X.XX up investor provide an OTO-XXX, at brief injection we R&D on in the event We open I'll summarize and with including any update have for March, OTO-XXX, the Beginning Paul call, to a plans then ask questions. line our in can we following results. period treatment programs, and effect, meaningful and all The the is of Tinnitus treatment.To announcing look months. month daily symptom baseline trial. reported patients the remains time the followed on same Phase the the to Functional extended primary assess Index improvement in based TFI, out for responder report. top we successful four A follow-up clinically diary as mid-XXXX. durability proportion who TFI endpoint or the completion in The for high points from for four months. of to of Compliance X/X results forward XXX the XX analysis to OTO for

half Additionally, as data, dosing XXXX. program effort for clinical of Twice we This results, the are program ongoing from dose with expect form initiating since OTO-XXX. start and well this X bilateral the the bilateral X.XX first trial patients higher close of and of evaluations FDA plan is to used in together tentatives Furthermore, important in Phase we Phase at as of XX% to of in for and evaluation dose to X results Phase evaluating are successful comprised second we're population. month the the approximately meeting expected support to higher of the the this safety milligrams. Phase one half two, the safety with the end in design up the X XXXX, X and Phase the

is for loss. Our -XXX next clinical hearing OTO program stage

hearing of test. Noise, placebo. Patients prior loss, placebo-controlled Following phrase hearing noise that cohorts, Noise, Phase injection a English Xa X.X being a with results in initiated the and enrolled common intratympanic validated hearing of XX randomize quarter milligram, that successful was is total Digits ascending early Phase completed topline and study dose trial, Phase the treatment for that of of X:X of speech Xa expect we evaluated Enrollment in followed American a X/X single a tests double-blind Words Matrix the and the XXXX. used patients or using randomized a in reason second schedule, and same months seek patients in patients OTO-XXX, cohort three This for the we ahead are loss. most three speech-in-noise clinically the for

higher Phase for the we dosing initiated Xa, of have also evaluation clinical OTO-XXX. to addition In

results Based clinical than a and from the the in in to trial, hearing enroll randomized dose-ranging at OTO-XXX important program. Phase end beginning trial support patients of X:X loss patients full XXXX. expect efficacy We XX more least the of to loss evaluation, Phase This next is X.XX X twice Phase initiate to dose to which dose placebo, successful cohort is or approximately higher on higher used this one expansion XA the safety dose X/X by the steps data and milligrams. hearing we expect set an with for

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

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

which continues patients or hearing two in otoprotectant an programs risk summary, regeneration -induced for are untapped both In with for loss, tentatives, significant multiple are markets on programs. with for need. loss programs progress patients cisplatin Our OTO-XXX, hearing loss. which Pre development in remaining unmet -clinical severe medical cell we OTO-XXX, hearing making large advancing at and treating for represent hair good repair targets our

for and presentations an the and information background trials our for hosting OTO-XXX. completion Phase the help of new tentative event clinical X be March for opinion include we demonstrate on therapeutic for XXnd. interest options and conditions. will Phase readouts, R&D review event believe This prepare Investor the these in both who loss, fact, hearing Phase enrollment key the and investors we OTO-XXX on leaders will that To X multiple In by results Xa X, trial upcoming early will provide OTO-XXX OTO-XXX

page of and and events call the next We the update steps turn able will hope for Additionally, for these summary Financial our you this a financial on provide to trials Cayer, and informative our results join to who which members management of via Officer, outline plan. session, registration I'll ongoing senior over will for the our that team us that, provide Chief website. are an on With is our Paul Business programs. open

everyone. expected good is in OTO-XXX were above primarily situation. Phase expenses and a due obviously which Dave, for trial X our you, financial our Overall, the enrollment Thank year favorable to the afternoon, than faster guidance for slightly XXXX the

the remains cash our us Sheet and Balance that gets readouts beyond clinical Dave strong multiple significantly Our mentioned. has

expenses more XXXX, Now exclusion financial stock-based are results let XX-K expenses operating fully totaling today's me million. operating million for in non-GAAP compensation. GAAP primary $XX.X of earnings reported the $XX.X The of we filing. that of release and described non-GAAP quarter expenses recap briefly the is the with fourth adjustment total In

So the level. approximates best is financial spending metric that our this

totaling expenses full-year XXXX, with total operating million operating the $XX expenses For were $XX.X million. non-GAAP GAAP

differences timing expense these guidance our clinical mentioned, for expenses. OTO-XXX exceeded to levels trial slightly the due financial As

of equivalents, cash half fund back I'll to second expect cash balance that, $XX this balance total into call Going of expect cash for to cash company over will investments million. of million short-term expenses be with XXXX With expenses Dave. the continue From year the to million including million. million, GAAP to a we that and cash, $XX.X we And non-GAAP turn the and finished the range XXXX. a the to $XX to $XX perspective, forward, we $XX in

you, ready questions. Thank Paul. are now we Operator, for

We'll moment the Q&A roster. [Operator to a compile pause Understood. for just Instructions].

Stacy Company. the Ku first and of Your question comes line from from Cowen

Your line is open.

taking for thanks congratulations with our and all, progress. the Hi questions

few. So we a have

path consistency we the as help how we all the David, loss, await you of in narrow XXX potential believe can you and is, with results. us understand results forward hearing the different you time to noise XXX question I mid-XXXX. in results, to some us parameters maintain speech next, patients can addition, remind about could for loss? expectations for Then expect if first should think are the enrolled the help The stated retreatment? for Tinnitus profile In the you place points wondering hearing of what

your enrollment data results room week week XX, to that expect our and give legal analysis. last for at suggests in math Given secondary let's for some endpoints update roughly, July, say should we completed

Tinnitus, thoughts And to and appreciated. the different some treatment in then considerations designing third, additional of So you there Thank speak from be any you. bilateral your recommendations would for trials experts? of can

is the noise allow Stacey, But that's be hearing profile speech to patients in the all of terms up the majority terms I with tests hearing that of but to, seen we've XXX that profound open mentioned, hearing we are we've three that normal prior severe one what as of loss, based moderate patient that we to have loss so loss to we standard patients well on show you, with do the the in patients loss population by the exclude hearing as hearing loss. and and that these Thank determined the speech that administer, audiometry. regard hearing and investigating. the and of logical noise the work we of requiring we in results What in means speech loss on noise the is are audiograms, audio profound performance a and And it that presented as patients do

the of that terms period lead In showing ensuring done really are of patients speech of that's which noise requiring consistency loss, complete these they the also a the including loss. consistency their by patients, hearing and in hearing in

and something allow of this terms initial of And patient the randomization of us is really patient. make well is modeled doing we that disease as then lead that a the visit prior -- patient We of in believe tentatives. the so the level, consistency our to all screening, have trials, ensures at, in evaluate patient ins, that, clinical and disease reporting of the that'll that as to including both the course, the with both

us that good as doing the is here something believe patients. consistency we're gives well, and that So for we

for with Turning we've FDA, be going expectations this trial, are in the to as Phase now far getting you're including will the is include enrolled X secondary all both as we discussions be ahead of but points, to more and with to specifics potentially our time, the And the XX, because if to we trial, look that -- potentially Week primary a and that results of Phase conducting time time, that endpoints. correct include Clearly we of as for XXX XXXX. middle that the trial I'll X it registration of package. just part say would successful are

you all through And that of would going the final have great obviously great for that can the database for taking as We're that doing as reason, care in in we process. patients, that will we definitely the then results in normal so are care take But say well to -- mid-XXXX, cleanup through. we visits program. a going database that go lock

on question the bilateral, the bilateral for tentatives then and Additionally, there. our plans

Importantly, tentatives, half about with it population. represent bilateral patient does the

perceptions struggle up not the patients, in they the But I patients initial our bilateral FDA of bilateral may that see it's safety on support, represent be end think program bilateral between their the there including for doing that the Phase meeting pending on safety Phase And XX% very based be the run because enrollment the patients data and for ears. reason, we is efficacy that that how the before may of the be believe them, the were in approach of unilateral with in our condition identifying plan years given it's to and may have build approximately the with obviously, the responses for discussions fast OTO-XXX data, great studies. year efficacy population would bilateral We difficult clear need able the enroll. in two the to to our end separating then to evaluate different based obviously studies to bilateral studies. and and X then successful to Phase that doing parallel the X we're the the of efficacy that reason plan that we safety in actually X our would to we in patients the really would patients,

the think that as Phase is represents talk but FDA patients address course, we'll with to those good we something, approach the of well. so end And a X that of at meeting,

Appreciated. so for Thanks details. much the

Sure. Thank you, Stacy.

from Piper comes the from Your Sandler. of next Raymond Chris question line

is open. line Your

for Nicole taking is Thanks the [Indiscernible] for on Chris. This afternoon. question. Good

So maybe two guess. Phase around I just the study, one candidate

XXX, naive analysis, will a and little is inform primary that there us placebo maybe some frequency design. is of maybe understand tell you we back effect in a Phase general? doing us potential Beyond remind or in injection And truly kind help how second, some to the on can for the more Thanks. I interested TFI, a the follow-up placebo longer-term potential of just were us guess, looking at then will III on bit previous what data effect the redosing your analysis, from benefit short-term or it intratympanic question. about

their X at continue beyond how is the months With looking the to respond outcome, Nicole. regard looking tentative to X, Thanks, and Week Phase really X, X at patients primary beyond what and we're understand in Tinnitus. to

to that X month saw Phase may continuing and we in and those observe patients, so X, thing same do period for redosing who the have other want that recall, is, to trial, then as you with As we well the optimum the the would if X to X improve; patients at initially. these The as be question respond we perhaps continue the where week is of patients, patients patients that over don't is course, improve those case, X?

of approval what think X; studies standpoint. the of then be month that which our and with month that safety X any information With the whether redosing, would us viable taking patient to And from the X, in into frequency Phase are so and and support would to of support the X X X, inform the would the would it would that and month looking of discussing with by the meeting, then regards FDA for safety or at program want clinician in we do very will a redosing safety them approach, month to to approach believe that product. take we regards we we that the be

regards any programs what a intratympanic been agency other we point we had would with our well have it very And was be in on only with safety. be as efficacy, the the on discussions placebo consistent field. at programs conducted time in previous redosing in seen benefit, that that's With this programs, the that do as to never Tinnitus benefit So we've and prior short-term of placebo. injection expect running that we've would not to there that

Of separate to from the suggest placebo just benefit. or any animal short-term course, you but will, has there is that that if that no would from us would difficult be work injection any to itself human a intratympanic from basis of our response very work

time in to And response with one was had may at analysis you think and that it responder the variability placebo to in is study, require month the the that earlier that points, really be -- where month with we and a patient response, that of that at the very two who the really to I meaningfully consecutive really X. think having just effect. essentially get placebo takes then saw small. attributed regards improved the I to Really I that be X patients we due placebo clinically away what doing we're think terms

our with results. X trial we will that's So the looking it at obviously interested and approach, Phase be at

Okay. much. Thanks so

Thank you, Nicole.

from Your Brisebois next François line question of the comes from Oppenheimer.

open. is line Your

Thanks for nearly taking progress my on the congrats questions, enrollment and completion.

couple a Just here.

XXX, to In consider set help why that's in just be not, being talk would the what endpoints expectations twice terms going you of just maybe okay can as the the a in dose a just can so terms big for you're maybe up then trials, when one And and what for efficacy? of and us help terms just trial. novel field successful about you side in safety as dose on the might of previous higher maybe rationale used you

With Great program never that Thank this And program to Francois. is with and endpoints we with our regards conducting talk our a endpoints. frankly, why time. the evaluated to are true and really endpoints, the FDA is Okay. at say has noise you. speech XXX to Thanks. this it with three

well the are noise the three the as be obviously test conversations that potential and trials. registration As to FDA. as data speech informed well be establish is best as activity the the tests of trying is well future forward safety trials We registration gathering carry productive in the what as way evaluating that of best to and to with we believe addition which would having In XXX, to

to drug. recognize Importantly, people used I approval need been the of think a have tests that never these to support

so. And

patients, As assess treat them they've and modalities they hearing been developed aids. developed, current understand help audiologist that as been the by those patients. can In they've to really such

of things think we're statistically understand obviously So that doing. that is to very why such not types retest parameters they registration three important also different are we're that because in advantages And to allows tests and for statistical it's have allow quite of disadvantages doing considerations. work tests future us the test different only compare the we But may will we us tripe certain trials.

it we're really So what a out. we've trying to looking we're to would what at also with successful to see obviously figure then trials, because time. down support Xa, and this Phase observations like, to stage is speech that of would, do going point trial what demonstrating do could look requires of confirm to and select additional the this had the test that give In test, if regards every to we narrow course, noise the data at or into larger that two we want can XXX, we that's specific would us activity a

to BDNF, profile, was very to confirms But with to are patients, very of dose good confirm up obviously course, Phase Clearly people regards and has there XXX very with function safety to higher of is if during of for the current then design a us that this regards be is XA. we as particularly something dose is of BDNF looking improving we're there a XXX you terms it to a do. we then a and That's those things bit our going both our gacyclidine used to seen, second noise hearing which connected the Phase of from that true successful was good your see opportunity strong XXX, development the of with results full showed with are always observations sense. would allow molecule, to remind good go dose what express very makes consider us is little of want Phase I really from and because profile it to is dose, the so X a but X profile you so endogenous. is clear X, the the a So embryonically, to that trial. the in in safety kinds that activity our We good what safety. up body and dose. could speech our and is programs efficacy do showed you developer, in safety potent have it what we've more With higher involved question,

profile In on patients fact, [Indiscernible] with a the actually showed safety better than adverse that events the fewer were drug of safety the related placebo.

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there the importantly think I thing. same it's

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say, terms but of the being I higher, of not we're also tissue should a an So in dose or target at temporary plasma, exposure. looking extension levels higher just

patients perhaps, be initial clearly, longer a whether respond there trial, in would would we'd period. even higher sustained might that, to our respond be patients X/X XXX what not So not those level, only level be, of interested in now Phase maybe because who there but X might

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last Thanks, too more a that the thought and if sneak just long it fact some helpful. solve, this that if turns of had I just getting in tentatives, for more it's central one it could maybe is late here, And this might too into proven extremely David, that knowledgeable have? maybe almost you've or to in is you're as tenatives that's problems

year. to no there two beyond there has it's switch field, field. one reasons question it's difficult there many or but central so a additional that no in one believe a It without central involvement really proven, the that evidence do of actual that one-year the but evaluate added I to why it a time we a three, It or from may with the to central. remains at which patients that absence believe Most the of definitive there's our who in of not conversion be a think of belief KOLs up period, looking scientific therapeutic, it's KOLs Yeah, is period, may type study point course set be maybe one that. think the is a into involvement, is peripheral -- is an even is of there

focus approach our that maybe events was to helps People example, patients side timing because an enrollment recently. on that opposed to which associated this clearly the out it really with is there something is not cochlear to, near-term so to to the us development damage due cochlea can are event tentative more our for as given identify recall the origin or cochlea. on the on And

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you. Great. Thank Okay.

you. Thank

[Operator Instructions].

question next line Wainwright. the Livnat Your comes Oren from of HC from

is line Your open.

serve I have for want Hi, make you'd you questions. you when this I putting be, in I too one few registration And don't the have this I just something a that or after as it XXX. want time you to to robust, and everything taking words guys. pivotal only your if your a that follow-ups. am Phase implying statement, read about theoretically X a much I could said talked Thanks that how couple sure into clarify as so that looks taking really but guess, do I are do to mouth. you earlier quality have of could study right potentially to this that. that quickies. interpreted maybe On on I

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yeah. correct, That's

So just safety. it is

efficacy we it, obviously, we're criteria We will have do the -- trials. get of we but don't the patients around some the like not readout in

think for safety trials that they I important running here So XXX. understand we're to it's are

X.XX unilaterally, at as bilaterally. single-dose well both at Looking as

efficacy. potentially just of two are at doses but the really into it going would part but bilateral moving probably support doses safety at we'd what only support which so that we'll results, idea well as well do X be to in highest with doses, X.XX, the as potentially to supports the patients that into that would of the And those is looking idea it on two based safety. Phase X.X X those at current that's really and And point, be dose program the as Phase dose with doing as in the

you of dose cohort. doing least Speaking at on one were you dose is higher XX, for said higher

tall X.X that go, or plan go expect than the might something. starting you think When I to? you higher patients, to

to period And higher have do we of at independent and dose. there's one good -- an to deem complete evaluate. for is go safety. safety, we then a a higher would specified We'll that patients actually if evaluates that escalate a they randomization We number a once Correct. What the we dose. then least panel dosing, following

apologize. And -- Okay. I lastly

if Clearly, event. clinical get know getting more XX we maybe look or forward we will to to for March even of really wait for Should going you I guys. before this or to have both to chance begin to a from have here. opportunity you much the there. some data some commercial that these don't we're dig products evaluate into perspectives more For one can the you also outlook robust

question. that address I don't let Paul why Oren, Yeah.

Thanks.

treatment themselves, to Oren, intent conditions a is key on then really burden, results. the makes and from Hi, leaders. focus trial review the on of that R&D standpoint pathophysiology, disease Phase the opinion of the mechanisms X, X the the sense by background All event

the when the discussion plan aren't really think a comes the opinion experts a tinnitus clinical really or key the from leaders since investors in opportunity. both is in good This commercialization, put really a Insta be that. where perspective defer for meant hearing primer context loss and clinical to So to on of and results until I it that then follow-on

So unmet and the patient that these drug no because other therapeutics that's that about commercial target some opportunity understand of for approved at and while tinnitus additional is loss. understanding but that we'll understand or hearing big medical are doing, something We do populations we session. lots markets this need not be

Fair enough. you. Thank luck. Good

Oren. Thank you

Thanks Ron.

further no questions are this There time. at

call Dr. Weber. the back Turning Dave to

hope call you, and that a virtual today. evening, for for And you R&D also join will look on Oppenheimer participating to with everyone. the good meeting everyone Thank us Have XXnd. healthcare forward at our March We you of event many in conferences. upcoming our Cowen

this for your Thank call. concludes gentlemen, conference today's and Ladies you participation.

now may You disconnect.