Aldeyra Therapeutics (ALDX) 5 Nov 202020 Q3 Earnings call transcript

Good morning and welcome to the Aldeyra Therapeutics Third Quarter 2020 Financial Results Conference call. After the speaker's presentation, there will be a question and answer session.

If you would like to ask a question during that time, please press star, then the number one on your telephone keypad. At this time, I would like to turn the call over to Mr. Joshua Reed, the Company's Chief Financial Officer. sir. ahead, go Please

good And morning, you. everyone. Thank

we'll morning's future I milestones. an call President Aldeyra. conference and performance forward the Chief upcoming Officer. statements begin with regarding and then recent David call and me our Aldeyra’s Brady questions. Business with will Brady Todd Dr. Dr. of the Please Chief of expected our our financial results third highlights are contains McMullin, On overview Executive and clinical your quarter note events future discuss and will take that this looking Officer,

regarding Forward things. or looking to operations, statements timing the expectations, These competitive position, trends, and other Company plans, and clinical include or upon information strategies available results business statements trial possible initiations, market growth of sizing, assumed research position, future opportunities environment among the Aldeyra’s statements industry development plans planned commercial the potential based financial and are expenses of and today.

position. and the forward potential the those site be materially could results in statements the delayed. on our current projected the no a our circumstances pandemic may timelines trials Covid-XX Covid-XX operations and As to update clinical obligation pandemic, Company's to affected events differ and financial of future of Future looking availability, patient change. Aldeyra and the actual including of statements, have from negatively clinical and as result impact complete been recruitment results these staffing assumes business,

Dr. filings over XX, SEC. XXXX the I'll with containing release could Brady, Chief President greater morning the financial for in with and forward statements to our in looking turn Additional Officer. And this the cause Executive detail to ended and our from press the Company's are that, September information results results concerning factors differ that Company's materially the call described Todd issued quarter

part to lifesaving the other This incredible good be on vaccines health eye disease United advance Thank why of and of being doctors, morning, you, conjunctivitis, unprecedented and science challenges in lines remind and the toward resolve more demonstrated conditions potential external common everyone. continue developed most therapies nurses surface reproxalap and Covid-XX. progress resilience one made alone. XXX this to the the the patients which than our that the exceedingly of of against front fight NDA we dry are candidate has in has proud disease an industry. and daily lead care been global The we the Despite of clinical Joshua, two ocular the life year, allergic are in speed with many professionals programs, significant million submission year, objectives our ocular against our have world's affecting States us

with and eye effect purpose visual drugs. levels, RASP doses will including assess airflow forced and changes on trial redness pivotal clinical Consistent assess and The with is guidance to This to dry chamber trial humidity, dryness quarter of we're levels multiple to Schirmer ocular on in the XX-day single to randomized Phase an trial finalization initiate to signs double-masked environment effect tasking. parallel-group tear exposure endpoint a the prior and a disease signs, sign the dry low tear and of will design, the of activity of trial of score. of include objective high range objective reproxalap RASP the exacerbate controlled X track of to chamber measure after reproxalap The a on symptoms acute eye of and disease. subject

treated XX in reproxalap initiated The accuracy vehicle almost natural Importantly, a assay completed and phase XX we will ocular X acute is patients. of applicability history dry tear patients. submission has patient by by recently confirm NDA Per drug From to evaluated To or requirements, no demonstrated chamber in track disease in itching month. exposure an plan XX with trial the of the more reproxalap in disease RASP we in in have coming dry and the methods, to of include a allergen of tested run redness in weeks a eye we we file on dry phase previously X,XXX safety NDA remain and year drug a at safety patients reproxalap schedule Phase following to end study observed dosing. the tear concerns. approximately disease baseline of an from to the patients on expected than reproxalap after is been begin study in submission end. safety run be we which drugs treated next vitro RASP levels immediately perspective patients activity which separate Overall, The In samples with XXXX. vehicle. analyses collected improvement XX and in standard in

of factors Enrolment in timelines of finalization development, of not be potential design, expected Phase X Covid-XX reproxalap has our review, may other including clinical patients allergic that trial our a regulatory number to subject Importantly, assay the of are in in due INVIGORATE to factors, with and trial results, completion positive conjunctivitis. all restarted disruptions of control.

will a outlast XB conjunctivitis initiation itching of pending expected X of during season year randomized positive conducted environmental XXXX trials are the Consistent half by antihistamines. early the end prior subject was results first being results review. durable of confounding the of and pollen allergic next chamber As regulatory patients. the in be of allergy and quarter with a trials, a what allergen reminder, NDA avoid paused unusually standard the an a response expected crossover XA, that an second trial INVIGORATE enrolment XXX beginning reproxalap care X Phase controlled extended planned score. Top-line in was in likely primary Phase is submission reported to of double-masked effects of uniquely Phase the year. Over demonstrated with and ocular approximately in clinical that endpoint has is consistently is vehicle trial, Phase and INVIGORATE the and

a in In the The of responder rapid tearing efficacy from XXXX data of features presentation addition highlighted data week as of and chamber chamber the American poster new of meeting. activity further be new conjunctivitis. poster well on Ophthalmology support redness of next possibility exposure rapid suggesting in in ceased. our Academy as will annual virtual and analyses of data ocular post The allergen Phase utility trials, the has to at durability, drug allergen the onset after X clinical reducing response itching allergic to reproxalap

novel stage allergic conjunctivitis as for about decades. late particularly we mechanistic approach these remain of For reasons, first excited reproxalap in the potential the

of particularly affecting XXXX the potential of Turning retinal to enrolment for pace sites recurrent more XXXX. the one Recruitment per States I pipeline, disease by call, across in surgery prevention United due anticipated of XXXX caused due QX noted the of complete cancer may retinal diagnosed to X and of XX delays underway many affects that proliferative or approved Japan our Covid-XX. the in States, ADX in slower trial posterior part X,XXX Vitreoretinal Primary XXX Phase at segment approximately to twice failure roughly than a PVR as vitreoretinopathy is Lymphoma PVR in the cause ocular by clinical of year to than type for in with the grade aggressive the United GUARD we new the detachment combined. this enrolment Europe GUARD trial There ocular are treatments rare, detachment is leading of high treat States the end or of United cancer. have and patients the ADX and been nearly has as people the our no PVRL, for annually. X,XXX to about cases severe expect also

our in for testing proceed disease orally patients of treatment letter programs, systemic a the September, our for Phase from received clearing ADX may start the available for RASP inhibitor of Covid-XX. adult X way we the hospitalized As FDA to study XXX

continue We expect the begin end. by to to trial year

initiate types asthma cytokine for inflammation of we by type and trials XXX represented the clinical production with ADX represented atopic Phase of plan to quarter production psoriasis. This THX cytokine THX treatment X by severe associated also

XXX the commonly As in regulatory and as potential tolerated suggested to current have cytokine immune of Based call, noted may treatment states in modulate events broadly engagement QX reproxalap to of in runway confirmed excellent animal observed trial. was inhibitors XXXX, storm model act We positive well states. results RASP subjects. conjunctivitis, operating described submissions well no that RASP were pro trial, clinical reduction the year an our anti-inflammatory Target XXX switches two months ADX I our expect from testing on through into the ADX observed of in on immunological financial capitalized was for systems condition. to allergic dry NDA and pro final cash believe including malondialdehyde we review. in treated in Phase disease adverse inflammatory head related are which inflammatory X in clinical trial in and we fund the plans assuming was potential operations and the that our

to turn third the review. for I'll Now, over the Joshua financial call quarter

Thanks Todd.

September with quarter net loss million ended $X.XX a XXXX. loss XX million research the offset in share XXXX. lower primarily costs, XX, million personnel XX ended of a related same well development were and compared a in For for clinical September for personnel the and quarter for was million Losses research the period period compared the period and trials $XX.X administrative expenditures XXXX, related with to The Research for to expenses million XX, other September and costs loss in $XX.X clinical quarter with in development have the Net in reduction September same ended and the XXXX, net increases as for miscellaneous The compared ended quarter costs. and development quarter September of reported of by per cost $X.X ended $X.X XXXX, $X.XX manufacturing is due decrease $XX.X compared XXXX. million as from with partially of XXXX. were related the $X.X general of General development the for $XXX,XXX XXXX, XX, and administrative expenses the same for preclinical lower expenses. administrative and million from $X.X is programs, and costs. we decrease resulted

of marketable equivalents cash, of include plans inhibitor same XXXX with September and as million of equivalents of and XX, dry including not diseases. potential were as to sufficient cash compared be pending allergic are Covid-XX quarter disruptions were control. operating X XX, expected on the marketable ended trial in and of due potential XXXX. X inflammatory review, XXX through reproxalap regulatory and operations ADX $XX are in fund be conjunctivitis, submission results, expenses the our $X.X marketable to Phase cash XXXX. that September operating to $XX.X in million NDA in in XX, total eye total XXXX our operating securities trial securities the for equivalents September also For and Use may cash, end one Cash, to factors million current cash the for and securities disease of period Based clinical expenses administered GUARD testing expected PVR in of Phase part RASP clinical orally other XXXX,

Now Todd back to comments. the for turn call I’ll closing

Thanks, Joshua.

ahead As keeping in we quarters forward immune month on quarter by for Partners progress lives presentation of we Care check in the look patients unmet modulating plan several potential Care This best Virtual Jefferies details. strategic needs. Please improve Virtual you can Health the our execute to bring the that We beginning to website you London tell, forward Alliance and this section milestones our clinical throughout as the therapies participating Global we significant and class development have with of on will busy Health XXXX. a Symposium. updated our and be serious Conference events highlighted medical

questions. of encourage would the that, Operator? you is Virtual With happy David, is Cataract of between com. and I Society Refractive take and in Eyecelerator. a Eyecelerator for the of be a event register to Eyecelerator Academy the new tomorrow's at American one participating Aldeyra Ophthalmology addition, In number Conference. I'll of Surgery. partnership Josh, your XXXX to American companies

comes please from Yigal the ahead. go Instructions]. your first And line [Operator Citi, Nochomovitz with question of

is the question. Thanks couple A Yigal. for Samantha this details trial. taking Hi, on on very much me. for Todd, for thanks RASP our the for

you're the And Just you setting and that of a which the more what they setting. the of [heat] days of factors quarter? has are the XX chronic are sort seems trial equally preference settings important this gating both curious, those combining is to important? like what before [ph] Curious more them the later or it start on FDA

chronicity no as preference question. to Samantha, and dosing. of is There the for from Good morning, the thanks FDA the

any In my pivotal significant as factors drug to could in doses signs that the vehicle. there are fact, in single we clarified don't do with changes the about We physically XX assay think or complete protocol. regarding confirm the analysed of to trial. confirm and in I tears the used mentioned between study from agency levels start pivotal dry-eye extracted And the RASP multiple be demonstrate comments and natural in particular for trial today, those be I of of intend, gating RASP tears patient, the will where dry analysis parts prepared history to we subjects.

phase complete However, at trial position only comfortable that will it in trial with year of this pivotal by this to will are not XX in a begin but end. point, our that we the be run year, guidance patient the

of RASP the going two them both it great. Okay, to design? that trials. same going Is And run assume have are fair to to you're

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there to trial. of are that outcome other some first changes probably depending the choose think on may protocol design I we the make

data second we'll comment think protocol for on to wait see the that have before can I we So design. in and to arrive particular

to of allergen now makes given got Covid-XX allergic forward? then how in about we chamber designed I and you're chamber? context similar Okay, prior trial. allergic the chamber and into And Are conversations spring the for using about entry into conjunctivitis the thinking conjunctivitis, RASP implementing testing had it. that for sense. you you the dry-eye And for the a are That the going disease both remember some

chamber, meet conjunctivitis. for or for entry. Testing there's is must eye allergen either other chamber. that or allergic a prior certain chamber of the dry at must think be disease I to Covid-XX, criteria either with now entry history either dry the Patients baseline, example, required trial of variety a met And to measures

The the patients dry would be patients or a eye disease must the eye for must at the of note the exacerbate I in to certain exacerbate trial allergic vehicle in other Patients that either the met. trial conjunctivitis dry thing after disease, chamber. dose qualify case baseline, chamber. is In must dry criteria of in eye

vehicle And quite differences we're we obviously attempting precisely criteria in So who enrol optimize about we're expanded. screening the that to trial. careful such are the between drug and

for you Okay, you the in to would great, one where that's me, helpful. for need spoke updates any Lymphoma, update last on one looking And you the were I'm what stand you any FDA, order said see file we Vitreoretinal curious to that, XXXX believe Primary if you I have would NDA then ADX just with on last data helpful. have with be there you

ocular treat of for You're therapy treatment used routinely the no to that's There that the standard methotrexate Samantha, condition. the is absolutely lymphoma. is care other of correct, really

is intravitreal to that's disease. formulation the for injection methotrexate no there approved treat However,

unmet thus why methotrexate, treat to has physicians are so there So with long medical is a is need. including discussing are you compounding with guiding compounding. correct which I that that of potential ocular infection, next quite ADX stage standardized ocular series it, FDA, process year. look And next a hope interest tremendous difficult best we're that very the in to on This strong. condition the early associated control advance is drug lymphoma our XXXX issues we forward doses how forth and in Today steps with and this in the lymphoma of to at by

the much questions taking for very Okay, Todd. great. Thanks

Thanks.

Fitzgerald. Thank line And from question next go ahead. with of comes Louise the Cantor Chen your Please you.

timing wanted on Hi, first this the Phase the talked for any is you've being question. Jennifer are reproxalap quarter, trial of by Thanks clarify Kim And still taking that expected two that's line for is of for I about My wondering for our trial. planned top just initiated the on was first second have Louise. RASP so XXXX? much if the end the before? X of trials I updates the question, trial So you that results this to

that trials By reasons Yes, of the first the the this first end Hi, that the explained of call which have of run XX the run remainder second as the trial. statistical objective pivotal power the begin Jennifer. dry first will, protocol It indicate the disease, in the that the a remainder Good confirm for for trials the will of earlier we important confirm will the the sign eye the the patient probably pivotal well assay and in RASP for morning. for from how I It a) give of for protocol will in year. XX the patient to year, working. will trial. is indication results an in will is trial, it the the in us

And it. by other X should And or I'm and these pretty trials end costs are is the wondering well. starting similar we XXXX, timing how the of the it's into ADX we you we pretty, XXXX to just considering know, and about as trials by a well? quarter XXX I'm reproxalap of maybe the on the going note, of that been R&D then that managed as Got XXXX? end cost SG&A on impact fourth starting just think Phase get for should wondering, maybe about the question, one of XXXX think also how

the question. for Thanks

and this in later QX R&D see that to you the quarter. be to next an expect So in trial given quarter this you into should you're increase in relatively initiations XXXX, over year. costs quarter with respect to SG&A, see year consistent And continue and you into way to that should the expect right,

thank you. Okay, helpful,

comes next And the line of Kim from with question your Justin Please go Oppenheimer. ahead. Thank you.

Good question. Jackie for Justin. morning, this is Thanks Yan the for

you additional the RASP So question agency? as based is, plan or an measure endpoint Thank assay from have any work additional and in upcoming it you updates how any to about studies feedback my first clinical on on think do you how you.

good morning Hi, for thanks and the question.

I discussed exist forms. RASP that methods main measured. protein there exist in in free the think measure also of levels kind two on prior we've are They RASP calls, in depending RASP to are forms. bound as

spec. to free approach. based the method And typical mass typical ELISA, proteins So to is an analytes which is bound levels antibody is the measure method of analytes measure

in are those we've with of trial assessing where natural assessment by use top that's methods of expect disease the which, we eye occurring precise indicate, what an the both currently So trial, from year I think, dry tear That's line that disease are I we the dry patients. and mentioned, the end. will history samples pivotal vitro we in method results taken as

RASP Thank the of then do How allergy. [indiscernible] in score of as know, will ocular And and treatment the Dave, reproxalap? you. on think described drive you commercial features you adoption what discomfort and for perhaps launch activity ODS combination your with about

a dry marketplace our think and and differentiation. I that is when disease. the the the product target about the lot for legs a of a eye of At disease reproxalap of question. on driven symptom is front thanks right, great Yeah, in this different - core differentiation one. We It's profile profile, there's you're

We that symptoms can it's and we've are inflammation, see one broad seen remarkable improvement the week. with you chronic this can so symptoms. exciting treat the product the reproxalap are in what in think with reproxalap And early of really at improvement also where aspects that

effective rapidly. treat disease can to a for successful, first able the that very condition you'll core the addressing use But we're you're have chronically. and the of if time So that also anti-inflammatory benefit patient safe the the to

symptoms, we that reduce our the experiencing the spectrum. ability see symptoms addition, the In or profile to patients are across the in improve

currently. The are indicative we that for. and needs, doctors experience And it positive the product is fit so a so know things into will is they that looking are unmet market current those broad don't advocacy, of itself. translate there a patients meet two we that and with more great solutions believe, Those how the aren't and more having

research, ability ones allergic can dry and frustrating - treat these effective for It's available biggest to can conjunctivitis. but of not these reproxalap, this one for and the to the overlap conjunctivitis do big all very address patients great addition, market unique make the of disease. is dry to seen disease drug fit not signs is disease dry a the that In difficult ocular allergic physicians how currently you we two also one an solution. surface again a one conjunctivitis one. It's disease, biggest here for And have to What's eye learn and ones. is overlap. The overlapping see And three is We've conditions have is symptoms not of only and treatment only tremendously. - of of make the patients. allergic to it with eye and of

seeing and is a allergic lot we're as product our we're patients. reproxalap doctors marketplace profile. future the and for and dry an on with the to added dry differentiator allergic focus so And for a where things while first have you that that the developing disease conjunctivitis, disease then of one profile would eye conjunctivitis And different for of simplifies the

will a are concurrent announced NDAs that such for programs that submit today be we as we anticipate to development indications. able Our we both

if Great. a or initiation. talk Maybe, just for can helpful. that initiation program question the about recently would resurgence thanks Covid-XX This conditions may, you specific is last make I site super given And question. seen in again, cases, is my or all criteria

not heard Covid dramatically is point. to impact at have We this that enrolment CROs from going our

for entry point, trials sites we required I that increasing or potential testing of that the as number Covid even free the including test of kind impair the and Covid-XX trial. benefit impact viewed subjects caseload dramatically that say But because been around has CROs in the the will clinical are either infections our country sites, at from to not as the around world As of have is rate heard expect This will the for to that possible the And you and continues Covid. enrolment it some is around per is working it's in arise and plan. could a many that hope world, that continue. Covid-XX cases testing is I patients. essentially that by enrolment. ultimate as this we're cases certainly mentioned, with, enrolment

Got it. Thank you.

Thank you. may your the go And Cross comes muted. next question Matthew Please from And ahead. Cross, Alliance. line with line Mr. your be of

Apologies, you thank you. thanks updating forward and the seeing looking at progress the to Hey, guys, for conference month. later this

couple a questions. of had Just quick

First on trial whether include of stage? and those consumers fact redness hit be this will just may changes of to of was be off, internally at handled any in signs I terms all and kind could rather, you the to devised some of wanted points, of need these was, Schirmer, directed comment or to considering kind decision know, statistically, of or updates, if design you there thoughts you whether more here, kind composite sign just the how on in RASP, FDA confirm multiple end here kind

as it that expect for of testing a multiple multiplicity test not and multiple statistical to sense us or I answer. Matt, question. is not so of sign for morning good short do made require broad, The to did the result reproxalap adjust assessment. is signs. The of FDA to activity the signs, a thanks penalties take variety

at from effect one studies quite data Those That shortly. as the for least trial now, in activity is redness good will broad the dry released allergen reproxalap back dosing. eye very and in to I dry on our drug disease we're that reasons signs, testing have a major see think, eye are the And is disease. then, results Xb Those you Academy an our will I a Ophthalmology this we redness. reason, for landscape. to disease for disease. reason a XXXX after evidence data Schirmer poster Phase acute of looking think breadth testing we're variety because in for at while redness in eye at released to recall, believe of reason within American dry signs reproxalap think of you I is the test good is more activity have dry chamber There differentiator of reproxalap the the are continue particularly additional generate of eye

discussed of with for versus I sense. wholeheartedly adjust that forward point and just agree, measuring you post to kind adapted commit kind this understanding complete running change the it first the in single wanted of at dry Thanks eye treatment I But of one is once dose. guess of study point, then in in rasp these that down assume looks [ph] freely to if you though the study to this the second prior this it of, completed, run versus there. the you makes of the a RASP even the mid Yeah, ways. we've for multi a natural [pushing] first know parameters. year, one of certainly just of the in one these another that trial. some of number actual, is of trials, and the fair to you second bit assessments, form little as may may guess circulating method kind a And protocol, portion running? of no, one and full or get different that know, is on that gone would analysis RASP and at to post take around know, I run - clarity I by history starting end this path whether

as absolutely correct. are Matt, you usual,

outputs clinical of a designed aspect couple trial. of to the pivotal the plan intentionally have us help We data

patients RASP results drug prepared this be XX to patients. the at cohort tears those the The which the which run-in eye patient And protocol to before the disease from working. really may of we’ll RASP is assays are in in good The will the baseline. to also earlier the study novel and natural as X levels confirm the are To the history protocol been tears similar dry new I've exposure morning, my of not in I of natural the functioning how be history a assays trial comments, first is well few of eye the change vehicle. a have design has the tested and good done. point, on depending function, The somewhat described your is in dry news tested an the is assess natural of bad the news main after very initiated. a serves is the pivotal history I've After of is those very They'll idea dry disease which mentioned this both decades. RASP run-in. as vitro Phase study sign in and first study, eye the mentioned The times

rationale And the that phase the is think in history pivotal novel the protocol for studies is the the natural area so very part think of the and rationale run-in so I an part that and for to and assays the and trial forth I confirm of of exciting.

design another to Todd. you interview you creative so I very looking appreciate forthcoming Thanks and no, the year. Yes, very the confirming guys, forward that from Perfect. end progress of the

much, Matt. you Thank very

[Operator comes with go ahead. Julian line the from Harrison Instructions]. next please question And BTIG, your

my good morning, on and for Hi, taking questions the congrats thank you quarter.

your study far measuring talk RASP wondering you learnings beyond On your a efforts? if any how the the assays mass history with and to could you're little and ELISA I applying natural there spec experience so was about ongoing

Julian, the asked. I'm thanks glad you for question and

chronic RASP of but statistically I RASP, treatment is baseline drug study, showed not think inflammation we that trial. Xa Phase Phase dry for treatment only change is in we ELISA interesting which demonstrated in ELISA drug dry time. mix, eye natural again, in are disease, protein an for of in assay part from another approach bound the over why it's everyone changes back because is important reason and of the the change eye to significant indicators which disease, after Xa after also history pivotal remind

I also what bound is is acutely. the RASP think that Phase possible, also on levels and on based literature based Xa change - protein the may trial, RASP

spec, of so run-in in natural assessments for of part is And RASP and alongside the ELISA to both acute changes RASP. mass history of as study will measure the acute using part changes chronic primarily designed which and be

lean if and how to missed done dry disease sorry on I very much it, that's work on you, NDA, the eye Thank but prior requirement there? great. needs you can then And safety Okay, still what for be helpful. data the

package, NDA extensive. safety of to which quite every generally The you as know, part submission, be is needs

prepared has more in a been my comments, in As patients. reproxalap I tested X,XXX mentioned than

no have serious adverse events. We

biomicroscopy that We would safety findings visual to relate no other that significant. any have or be toxicity assessment or or intraocular fundal or pressure acuity

will So are safety comprise exposed or to in been safety we're patients have to the in X,XXX submission. trials, the patients Those and so population reproxalap for of NDA confident number safety the package. the that quite added assessment that our

portion is patients your think are safety the the with I there FDA the of a of to of you number safety between and in NDA, prior that exposed dialog and been indication how that for your required precisely of many number have patients intend is any trial. the clinical the function to sponsor the as patients a in that test trials

given a to to date. reproxalap the be an over in complete X,XXX safety excellent we're that clinical in we've across the lack numerous though, with safety patients position amounts and what issues observed think, trials results of I

very much. Thanks Great.

Thanks, Julian.

our with ahead. And question of Kelly line final Shi go comes Please the to Jefferies.

Hey, taking thank my question. you for

level on the on generated you patients] level design first part is dataset the select of And X secondly,[do same question RASP by based on also trial RASP. is And [ph] the baseline reduction. And criteria trial. Thank you. study impact RASP the [Indiscernible] what of trial also of the that [indiscernible] as on outcome? one. RASP Phase baseline of The the has

hear for thanks question. to for voice. Kelly, the that. Good your Thanks

I criteria standard of is There eye or less are, not and across group all for dry enrolling and enrolled disease certain more thus substantially to must in trials. clinical trial. in identical, and a certain that criteria if be RENEW as pivotal signs the dry-eye the patients similar trials. enrolment patients qualify Patients upcoming have think symptoms

from intent not extensively. those or standard to less Our criteria is deviate more

this particularly year. the will in us. point levels natural the RASP history Your to require certain results question about we expect our baseline depending change at may RASP fascinating not That on of know and this I expect trial. enrol to for study RASP results for We'll relates comers trial. at enrolment levels is the do run of levels. lot tear towards all point, the as pivotal a the the we I this it of end more phase in will But

baseline that disease tears hallmark question, dramatic theoretically and an the elevated I level the effect do we elevated RASP in levels, RASP be a One priori, dry condition on eye inflammatory all expect dry your effect are drug? of to activity eye to does the know thus know what in be We is have Phase answer inflammation. ultimate A subjects is the of reasons. Regarding two RASP should not patients. for from that trial, Xa have essentially our rasp all

in The molar RASP. [down] drug in levels RASP has probably drug think second major millimolar level higher is of will as most, a [ph] reason concentration. in for been in maybe the I range level baseline the role of is micro is the published, tears, play activity of that The low at don't

thousand a the previously, drop expressed eye of So essentially drug of represents levels surface as to more the of RASP. a relative of single anterior we've to administration fold of excess or the reproxalap

one So whatever range excess RASP unlikely are in large be in to RASP that of a binds concentrations one the reproxalap; reproxalap to of are by micromolar the baseline stoichiometry. to affected recall the

be after near think I RASP of of the there whatever acute drug, level. So should total theoretically elimination administration baseline a

expect much. case eye other specific novel from do you Thank question a It's reproxalap you of this mechanism a I hold very regarding from have any And dry study. since very also, FDA second requirement action And helpful. drugs? the

eye agency been do across The inhibition dry discussed extensively of with the and I very from the allergic conjunctivitis. not. of novel beginning mechanism RASP disease reproxalap has action

an objective - of think as dry the in for that agency RASP RASP as inflammation. in RASP eye I speaks point sign a ocular agency's fact disease end the as to mechanism treatment the confidence the beneficial awarded a inhibition

relates heard been of tested prior specific the number comments no RASP to from as inhibition my to that expect patients And about have not the on have concern safety. agency do and again, that change. based it We with I reproxalap,

Thank much. me. to That’s you very hear. all for Great

much, Kelly. Thank you very

Ladies and you your thank questions. for gentlemen,

any would closing for back to comments. I over the Brady turn Now, Dr. to call like

stay and you there, healthy joining again Well, we during please behalf always, updated on you forward safe keeping thank progress. as and on the holidays. out for everyone of to our And us look

thank gentlemen, Ladies participation. for call. conclude you conference and today's does This your

disconnect. You may now