Aldeyra Therapeutics (ALDX) 11 Mar 212020 Q4 Earnings call transcript

Good morning and welcome to the Aldeyra Therapeutics Full Year 2020 Financial Results Conference Call. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] At this time, I would like to turn the call over to Mr. Joshua Reed, the company's Chief Financial Officer. Please go ahead sir.

morning good and you everyone. Thank

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

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

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

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

good morning and Thank everyone. Joshua you,

the move advancing for call lead important, as made we strategic an you development. our programs vision the progress stage share Aldeyra opportunity in and next clinical with to Our to in the our year-end is equally we've

Over three have quarters, focused the several on past we primary objectives.

X clinically positioning ocular redness, Phase novel acting augmenting and trials eye previous advance achieved Phase into potential our First as X in Phase and in sign of a dry compound X improvement trials rapidly relevant two a significant we the first-line symptom statistically therapy. reproxalap disease,

enrollment potential complete pivotal trial in in succeeded February, by in our entrant reproxalap for conjunctivitis, systemic the disease. to INVIGORATE TRANQUILITY novel of our the of and eye ADX-XXX. have allergic we pleased all fronts. reproxalap disease and dry Second, retinal we advancement decades. X Phase the our begin the I'm highlighted And In first therapeutic disease design explore finalized report this of third, facilitating the treatment assets Trial on ADX-XXXX of as of that to X as Phase

enroll primary expected trial The design, Schirmer's with RASP tier criteria eye of cohort. run-in and in dry and patients endpoints. dosing The arm. of previously levels, the to two-day enrollment approximately redness per eye we dry eye TRANQUILITY is paradigm, announced, symptoms endpoint will As secondary protocol replicate as the XX is challenge a dry the chamber minutes ocular have XXX over test,

year XX has that I'm soon today therapy enrollment TRANQUILITY the differentiated eye in confirmatory exacerbation to first-line of as no Completion or retinal the of are even are XXX to with results of half allergic Patients mechanisms the is on X.X by the in been of of patients chamber year. continuous a program relatively an a expected a prevention day reproxalap must all the significance as entry. small care exposure a single five as the and Phase of treatment-related run-in also dry also the subjects begin majority in expected in our has administered X in the a and and of a trial significance following and status INVIGORATE PVR regard vehicle, results expect XXX schedule in of ADX-XXXX drug conjunctivitis. threatening the for clinical this the disease trial approved treatment. the improvement time of vitreoretinopathy in our Likewise, granted chamber health after minutes ocular to ocular therapeutically prophylactically itching we successful that Phase trial of reducing of no rapidly. on observed enrollment was serious statistically remains Reproxalap been primary redness as and the the eye remain RASP part line ocular well symptoms demonstrated action, for middle statistical available continue to relative following our the after is XX line FDA the TRANQUILITY-X demonstrated adverse dry to Phase preventing The and compared and results in eye And statistical a orphan for on second trials which undergo and trial, end disease year. patients acts pleased by the is from top end has dose and retinal eye benefit expected first fast-track lead minutes reproxalap two-way to is signs redness no dosing before inhibitor times year. after of potential little five X single allergen exposure. Phase of chamber chamber allergen of symptoms in in as randomized minutes dosing reproxalap well signs follow The in efficacy from cohort, and Although in this clinical of the achieved orally number with act minutes dose. Phase And assessed events prevention disease year. of therapy providers dosing. symptom to site lower half drug within hours With RASP first designation PVR. in dry on this the in dosing. symptom and minutes, top no of at There first subjects safety half provide of dry trials occurred is points disease treated trial proliferative with symptoms was experienced. X control track. to any trials observed X one as the of of GUARD also ADX-XXXX the to programs, tested. X-point ADX-XXX, weeks, with Symptom persuade X dry or in between disease as line the levels scale control report endpoint eye PVR, systemic improvement clinical at to Phase in in the for chamber. Top patients. enrollment crossover for ADX-XXX, INVIGORATE Based a Progress assessing completed on controls chamber. X

As well-capitalized part as of also the molecules an and for strategy, disease. The industry. of strong systemic obviously our year. are as sheet in clinic new which and our longer-term development lead early we asset readying A retinal balance could important is next clinical compounds be in

to public will operating for expenses be we With our our offering, the We completion million raised XXXX to execute anticipated Aldeyra, which began great of nearly current sufficient fund end of in underwritten Joshua that financially. and believe $XX January our cash gross through on back plans proceeds shape in our from of call operating and support new With gratified review the institutional financial for We the the current turn investors in to the over XXXX. results strong were XXXX. I'll offering. the existing by participated that, our

you, Thank Todd.

allergic the operating and fund cash sufficient As cash eye the including PVR. offering representing underwritten common million the from and at million disease, the Phase full public generated our of end net the the Phase X And included XXXX, estimated the of of in announced completed existing offering operating X,XXX,XXX in be and shares, deducting discounts, net per in we Cash gross the option purchase and that dry December clinical completion on and were III in as X and trial anticipated public the Based COVID-XX XXXX, conjunctivitis, exercise equivalents proceeds commissions will Todd TRANQUILITY-X a of of to $XX in psoriasis, $XX.X cash plan of the of The including January trials of GUARD trials of X million. closing ADX-XXX expenses. TRANQUILITY of proceeds of stock of current trial Part INVIGORATE and underwritten the X January, through adaptive XXXX, the completion price believe $X.XX underwriter's we to share. offering after noted Phase proceeds expenses and the additional X,XXX,XXXshares $XX.X Phase an currently XX, asthma in shares. completion offering atopic equivalents of of approximately

our an year administrative acquisition legal primarily The XXXX, with full financial full year expenditures, the to G&A decrease Act full clinical to the million, expenses $X.X development loss miscellaneous development XXXX research back million expenses compared comments. offset expenses closing XXXX, million full in full or public $XX.X results. and non-cash million year a for the XXXX. of million With R&D $XX.X decrease and compared XXXX. or Vision. net per share associated the portion of year per personnel for full million with call in-process for to research and Sarbanes-Oxley $X.XX was the of costs, with related in-process million for with administrative were company year increase development Todd expenses now compared that, $XX.X share, The loss were contingent year turn I million costs net XXXX. $XX $XX.X million reflected costs, will primarily lower for a decrease related research $X.XX of compensation compliance in year to full costs for the reduction and year XXXX Research full were compared related for acquisition General in and for a The Turning of with $XX.X Helio The year expenses partially full lower million XXXX, for continuing million $X.X $X.X development to with reflected $XX.X and XXXX in is a milestone. Acquired of $X.X XXXX. expenses by costs.

like this at we'd line the to for open questions think, I point. Operator,

will Your Instructions] Nochomovitz [Operator of first go Yigal Please, ahead. from with come the Citigroup. question line

then levels the endpoint? And Could obviously, not just on bit questions. INVIGORATE? the running taking to that peer for around rationale as redness you endpoint, rationale secondary Thanks you. redness choosing a RASP could in team. in a TRANQUILITY, expand in cohort and ocular primary the endpoint as that, was little primary if a for the Todd choosing you Thank the Hi, primary related the given, ocular explain

and question. the morning thanks good for excellent Yigal,

of signs pivotal know. We disease it comes the dry of objective of approval. when reproxalap have those a be and for number We we as three relatively are for think, in TRANQUILITY riches can statistical achieved used terms bit redness selected of very a running cohort, of of in the In Any in in RASP, could redness in couple patients, test an ocular endpoint XX running had embarrassment Schirmer's cohort. that we you is, activity to ocular of trials. reasons. and significance strong. One as a the I for select data the small total We a

X that concerned especially, patients it's to previously And only are the selected that redness majority reason related advantageous redness. is could complained the improve a trials. second the about. you time second about activity allergy as therefore, closely this And was Phase the that in of chamber is quickly care also that, redness physicians signs redness in probably the is beneficial achieved patient important The Ocular to most considerable we've is and can disease. care. was thus this we've Ocular and know, demonstrated announced ocular to allergen to of is I third dry the redness, having redness Many drug physicians the drug disease. can the improve ocular redness label important ocular in therefore reason that advantage that, be most ocular quite ocular a redness that eye patients vast drug. and the a And commercial as is think treat have sign there

Your one. question secondary about as a in selection the redness good endpoint allergy the trial a really of ocular is

label conjunctivitis. of For sign as redness for approval redness of having on primary comments commercial as I ocular itching ocular generally a approval primary only INVIGORATE. allergy we've the think that the therefore, well. not allergic endpoint there secondary redness ocular endpoint based about prior also designated ocular my allergic is is the but used, it's required conjunctivitis, is is the in that symptom allergic key redness advantage conjunctivitis, Ocular do for and is that in considerable to

amelioration to eyes when of patient are and redness All add the of care. appear does concerned red us our

super you. the us there? a patients for other one helpful. COVID-XX That's help hospitalized more with provide these moderate, us detail you respect to Are super, requirements you little Thank just question. just Can And Could trial? severe, hospitalized criteria not bit the enrollment understand the mild.

Of These centered those criteria course. with are The COVID hospitalized. patients patients are disease. around enrollment of many days moderate not

and most anticipate for COVID of will of we hospitalized on of as going outpatient be the the are My guess a mix COVID way populations So trial. is current outpatients. things the patients the treated care treatment based and status

Todd. Okay. Thank much, you very

Thanks, Yigal.

of comes Louise go the from Your with ahead. question line next Please Chen Fitzgerald. Cantor

this and the all taking progress on quarter questions. thanks for Congratulations my Hi.

the on So first TRANQUILITY was trial. question back I had

eye they the FDA dry eye your getting different developing product think crowded is XXXX? that? about of treatment it if is curious different many disease to with primary what just And you market had I'm how paradigm? you. mechanisms if then the expect to and disease. think approved curious for about Just is, for And we a I just then Thank do endpoint secondly, speak to dry the expenses question for might have into should last your chance companies operating where you've fit you

held primary for and specifically to was Type morning in third meeting questions thank the The last position the clarify you I'll address financials. FDA middle year the designed over first agency's the to good potential endpoints address our the the on of C and to Louise, the turn question. two Joshua for TRANQUILITY. with we

Other eye redness we of as have be rest at that can assured primary endpoint. redness least companies agency relates sign used a objective dry redness that You clarified an the with to a can endpoint used as disease. as primary

case. we're will our be that quite redness comfortable So acceptable in

of agency three of the as being redness as an will know And used Schirmer know TRANQUILITY with clarified you the also also of objective assessed possible trial that dry you the All also reproxalap in a primary and RASP sign As be can signs. target ADX-XXX is test those the endpoint. disease. be

my paradigm in for does reproxalap treatment of eye is where topics fit the dry favorite One disease.

red is the work for Reproxalap weeks patient. take shift in what a RESTASIS for a experiencing before therapeutic my three having and today. no is often look provider. a XXXX, RESTASIS office. not one therapies There available dry mentioned patient more present Xiidra feel provider health precisely is is in that do the rapidly remarks, of for not be the TRANQUILITY, if published of of to could care is dose theory paper patients leaving and as administered case I've challenging when indicating the care in median chamber II if the office and because run-in I of in was disease just the that rapidly. theory, are convince only major to reproxalap As assuming symptoms, which between manner prepared eye has but patient drug was stay on eye And minutes for provider there to the the trial the that of eye health That in landscape acts true and in is healthcare perceived healthcare the months. within to is one many a therefore dry the And eye In drug dry healthcare then In treating cohort currently described demonstrated to Xiidra is paradigm benefit also patients that is major patients offers happening the reproxalap present not the a allergen could issue issues, treatment quickly. the of nothing better feel providers. to and today problems in could months solves that patients often and a better. the that the times provider's to Phase discontinuation

For today. the disease you financials? In onset solves therapy. with is believe represents summary, about problem rapid reasons that do all key we therapy Josh rapid advantage and of to believe talk primary dry the want first-line the we reproxalap a these onset

question Of XXXX. systemic our planned should our increase in R&D in you for INVIGORATE XXXX particularly Thanks in expect With TRANQUILITY-X, the program ADX-XXXX Louise. versus our advancing activity ADX-XXX and course. TRANQUILITY, to spend development including

as goes quarter-over-quarter a As far progresses. year can timing know spend anticipate as be would I you that but that the our bit increase variable, as would

much. very Thank Okay. you

Louise. Thanks

Please line question with ahead. Kelly Shi Your Jefferies. next of comes the from go

Thank for I conjunctivitis. taking for dried expected filings the both for question questions by the great you have congrats my and [indiscernible] and year on this a and progress.

other the question. ready? to the are work top And for actually area given That's that and like they same things my what on Beyond indications? willing getting Do marketplace two package primary line overlapping -- question you. see should second endpoint? think the we also these ocular is now share the action? you of do reproxalap, about can you are data of how one share you And where working you also mechanism Thank the the promotion first of

Good the which is Phase demonstrated in TRANQUILITY trials trials. activity voice successful for aspects your only a the -- signs. drug of optimistic very INVIGORATE morning. hear allude and II and not are and allergy have and about one reproxalap symptoms of running based are optimistic of your about very disease prior we're mention and efficacy Obviously, many to trials to to TRANQUILITY them dry questions. on the thank of cohort that good Kelly, you we're There submission you application new the in

other requirement safety NDA studies concern studies. of submission NDA Safety a submissions. components for The are

is which throughout the the from X. database, in of safety been really exposed the program of magnitude the is starting beginning clinical that have Phase studies a drug the patients safety to all to addition summation In

have forward. concentrations that exposed a over that dosing been X.XX%, to frequencies intend dosing the or frequencies is at slit eye, which forward intraocular we or X,XXX have exceed have fundoscopy, patients reproxalap observed exam to no typically higher of We taking visual pressure that now take concentration front of than experienced our lamp events. the And at are events. are safety using, concern and currently acuity, Which we adverse the we

subjects drug remarkable clinically it's exposed issues. have trials we so no of reports and that relevant safety been many have think to I clinical in

the by for certain of is only FDA we trial disease patients I'll good to there number we I'm The to The and third aspect And process six concerns a we're thing say And add standards we're and is batch. commercial regard the exposure controls, with to as end NDA of the for ongoing. stability drug. is commercial we requires that submission of happy with to manufacturing very all the chemistry of process, submission that months milestone safety have dry the to year, Kelly. concerned The primarily believe the on C&C. the as that eye in they relate NDA this believe manufacturing those FDA reach shape that with track that of

your in terms reproxalap. for opportunities other Regarding question second of

We've inflammatory one trials immunology Kelly, corticosteroids, are acting not space largest for of drugs component announced There eye, in in probably, two benefits is reproxalap conjunctivitis like think that like not many cyclitis, of are involves company and the use immune immunologically as there of some an And and of broadly previously other for active being most the the I diseases the applicability. certainly, therefore, if have think, is uveitis, if Many considerable. are that segment. of And know, Allergic inflammation anterior are broad. other I segment applications mediating that scleritis. are the drugs the disease potential you the there anterior to dry are diseases potential them. anterior the diseases if diseases. broad inflammatory have but products

significant. focus to of Our on application the to disease plan conjunctivitis, currently eye and allergic road as potential however you reproxalap allude is is dry down but the

again. much Thank color. the for you Congrats very

Yes. Thanks Kelly.

ahead. the Please comes question go from with Kim next of Your line Justin Oppenheimer.

thoughts scope morning. secondary Thanks on the about the powering taking TRANQUILITY. primary studies, just how the you think one Hi. Good points? size about could on Maybe and you the of think question. for you share and the any for key the When end

Yes, Justin. happy take statistical We very powering seriously. to

power the ways trials. which threshold to power. to XX%, is companies most policy biotech company generally There for that is at clinical different are use Our enrolling several conservative

believe conservative powering powering between all As on X.X the In we the the cohort point use ocular I'll detect We cohort, RASP get the to power powering XX%. based we briefly And approximately threshold to TRANQUILITY cohort. main we data for is redness be for differences comment you RASP XX% run believe, the differences know, that powering most at that the I pick less this the TRANQUILITY. or is at difference that, redness. should in RASP. on the also slightly powering power for for in were units. than to based groups of from includes running on to

So those covered well two end points, in I believe powering. of terms are

portion? have Maybe sort as patient? dry more you could of us of sort variability may in we on Got measurements you I which in were you offer sort some just that less that think then patient running the there mean it. there study the inter did color taken is and endpoints about the or eye based of disease, Thanks. the population

as interesting specifically considerable. question, among variability disease hoping very eye in is knows RASP really variability dry the measure that disease Justin, A considerable. of everyone We're objective the provide because a And endpoints is severity.

shipped a central somewhat an that such Although, Tears reader. must color, saturation, the those so cetera levels are by the redness must complex. we disease digital performed much for controlled. the time frozen, assessments. believe be the central to rigorously standard, dry photographs a And assay requiring contract, Redness, intensity, central as including digital by hue, mentioned, than all analysis are is forth, then for et eye we've and for a extracted, assessed we TRANQUILITY be read more controlled with studies, lab, light photography, is reader RASP

eye endpoints the will ocular by variability for the dry that some So we've we controls be see with we're that redness. limited outlined hoping that

it. it. Got Got

us a of and INVIGORATE think hurdle respect should a just for Just with as maybe the the the endpoint bit expand commercial you rate there? we Could on regulatory little hurdle well hurdle question. Phase maybe study the how final to X about as sort

stance therapy conjunctivitis. is duration of they're allergen and that allergic is conjunctivitis a duration assessing well and The allergic exposed in suited and particularly because X.X to FDA onset allergen The to vehicle should interested majority, onset on chamber are achievement mentioned interesting particular the in remarks particularly over say, patients continuously the hours. at the statistical as a prepared of And points in is prespecified a my endpoint I of I primary assess and time range. significance between in over majority drug a or

onset be the drug But that range in see a our for drug on the can majority time drug. range. looking X and of be also that first that FDA FDA Phase specified deck, of will data, was is the we be range, expect that highly of sort and point. duration time significant to drug the Phase only the but you the that between corporate not is Based acts the Within the using to in statistically to achievement assess the the last time onset the vehicle. of X As we or long endpoints points how the would within and the rubric point

Thanks it. much. Got so

Justin. Thanks,

Your of Alliance with Global next from line ahead. Partners. the Matthew Please question Cross go comes

of progress. quarter Good on guys. another Hey, and congrats morning

housekeeping me of for questions today. couple a Just

to pacing or TRANQUILITY time as we're enrollment quickly, of overlap second was you for and about anything and can of we of versus any of three of anticipate of between between read examining? year, considering being can may And Phase more more given remainder kind sense may expect there two about how say completion these the between for second indications studies, X? So trying X, these thinking step X and year these the endpoints of one kind and from advancing that had you distinguish Just would there in how of lockstep the year? by much intermediary you'd the of be better initiation remind half you will and this more or of three? off, I you're studied for the less first that I them different design, the the any is first the us in in kind lines is one similarly Thanks. should virtue time slowly, year end then start these these lead themselves ADX-XXX the another? throughout out this clearly or more a quickly get Are complete guess

time TRANQUILITY-X TRANQUILITY-X not in are to TRANQUILITY-X, there is with stagger is morning. Matt. intent that reason and between in adjust changes TRANQUILITY-X difference as for of plan The stagger but TRANQUILITY-X. to and sure TRANQUILITY-X that is measure the prior changes replicate TRANQUILITY-X. intentional significant we to to analysis make accordingly. results Thanks, and want just conservative Good be the TRANQUILITY-X no statistical do any need I to some analysis expect database lock the of protocol terms in This TRANQUILITY-X. allows of if The a an us between zero. is There The analyze stagger between to timing have the TRANQUILITY-X is needed.

Regarding depend exact COVID trials is for the COVID the three say for over early I all of and trials of enrollment will trials summer. by and factors those on Phase less Phase psoriasis to results terms and the in but XXX, the the other how point, at X are affected for timing enrollment X the would too in this of lockstep say more asthma timing. and or

time. info Appreciate again. and it. Got Thanks the

comes Please Julian Your from line next Harrison of BTIG. go question with the ahead.

question. Hi. for Good taking morning. Congrats now my there progress is and thank some

mind TRANQUILITY here overlap. pertaining worth should highlighting to each? we settings data especially to conjunctivitis the from any wondering albeit the collecting First, about differences involving redness thinking between upcoming be beyond I'm how there the trials Are data different you're or chamber allergic are significant nuances read-through both keeping with in other conditions your trials in in

dry data Per release and chamber our and a And the activity included that usual think whether allergen that same eye do allergen is dry slide a chamber that I within of the to between an eye across The trial allergen Julian, readouts four symptom slide it's it's we deck, chamber the an way excellent point or point had is eye chamber trial. and the behave dry about all trial. whether and that in is and redness, TRANQUILITY there chamber the minutes. or sign reproxalap read-through. seems chamber run slide the read-through symptoms

are So pathophysiological both that our have do enrolling is do between INVIGORATE that studies And read-through population patients overlap. some a using and are think chamber. I there challenge both TRANQUILITY both a of

the two I therapies induce antihistamines mentioned between of you exacerbator pollen. Yigal's of eye allergy. specifically including in about ocular Julian, itching. for complain symptom is of overlap your exacerbated conjunctivitis for an disease. about and it's dryer which overlaps one the about key dry including of populations know, As these as at to the Pollen allergy, XX% also Also patients And that there patients, of there to eye And other half the complaint patients half dryness a the complain are symptom the of question eye itching, allergy patients is my complaint of the dryness. key allergic dry worse answer seems least obviously matters many a probably therapies patient also disease to but itching make make eye and dry And the allergy. between

overlapping protocol So population inflammatory chambers. in also patient I terms signs INVIGORATE rapidly themselves terms boot terms trials to the segment of TRANQUILITY have overlap and in seems in behave reproxalap But the And the these only methods. would and pathophysiology. symptoms in way is of improving to of say and anterior the same do not

Got it.

we sorry NDA anticipating without need Okay. an Thanks. I you forward. possibility program. missed an Are wondering, if to clinical file trials? path should vitreoretinal expect That's the on when then update any I'm on the it the lymphoma And for helpful. the still

is, I answer diseases with potentially, ADX-XXXX hear and The lymphoma plan think shortly. treated will can from on Aldeyra more you path with other retinal our be forward that

Thanks much. great. Okay, very

Hong the Your Esther with next from Berenberg. ahead. of question comes line go Please

morning. good Hi,

as and for for that about So for Thanks. potentially reproxalap move the dry eye approved disease strategy reproxalap speak programs you forward, AC? will can both commercial be the

something we've is a that historically strategy good lot Esther, thought Hi, The about. morning. commercial

NDA As strategy point commercial go-to-market you and as out is important. particularly submission, reproxalap the nears

reproxalap in mentioned quickly. A believe mentioned the get long previous a to reproxalap current given take marketed be or is As to is launched therapies that answers, the time reproxalap well-positioned question often work Aldeyra. seems we I today market to in is, going as we work I by that and

from the dry launch are optometrists versus think across do-it-alone a of of therapies the is general we that to anterior care segment to I providers the good a practitioners, news nurse On have patient partnered hand, practitioners optionality general spread many considerable one eye prescribe launch. around ophthalmologists to care the continuum health disease that ophthalmologists.

commercial wide So by there's best that is a company base a served significant with footprint. a prescriber large probably

have their own. other hand, ophthalmology and on companies the launching small drugs segment On are anterior

for Aldeyra many standard do feasible is that certainly on think it representatives, companies I XXX have launching the So I for sales in is as again the XXX a to which range on it's relates force In eye reproxalap. small to of summary, companies. options we well. feasible that of so launch based could the as believe other what sales are executing that front currently

base limited. Regarding rare companies' not do these Retina, but the ones that not Aldeyra's I a on think prescribing small probably are because retinal diseases, that something In company the do case, do should running even diseases cases clinical is retinal is prescribe very can working the trials. that maybe but physicians are for the Retina rare drugs only other only

company. to very the And familiar so that prescriber base is

That’s very helpful. Thanks.

Esther. Thanks,

line comes of Wainwright. Please question the next Edwin ahead. from H.C. with go Your Zhang

Congrats primary on compound progress. about of the talk ADX-XXX, the X bio for psoriasis, Phase Thanks for one study briefly your the the in Can example, for taking have size the strategy. recent primary systemic quick you. design a the endpoint my I on Thank the you study? questions. of and

represents Edwin, a from talk a Thanks segment for transition particularly think to been anterior for and it company ADX-XXX I'm previously ADX-XXX, I ocular on transformative to ocular disease. disease because event about our primarily we've represents disease, systemic as the thrilled question, focused

testing larger with is ADX-XXX. Phase As There the that diseases is immunologically we ADX-XXX. the you systematic, to particularly are of approach of and than well number thus X immunology the systemic number the trial in thrilled of thought know relate a launch diseases the considerably for to eye out based, that are

studies. COVID, XX the autoimmune results testing is trial time continuum continuum, numbers of a year. by of asthma, terms we're these for patients. trials able know, available trials. endpoints, levels. of In psoriasis, patients you And key case proof-of-concept mentioned kinds In comment happy the The of on of particular, Different controlled mediators are and case COVID between we're our proof-of-concept camps. all because ADX-XXX. the the of of our activity the trials. idea is inflammation. I XX and there cytokine psoriasis, thus, exist safety cytokines, guide single-arm and ADX-XXX. idea but I'm next by As that other cytokine are response a Xa in biomarker in adverse on generally in Obviously, primary pro-inflammatory be and trials trial, sit future of and disease. will on events all Phase allergy Xb both of to There and the the the different XXX specifically kinds profiles the particular, these they are at along we're profiles, the different development each the really are looking the for protocol a as and affected the assess each to and are In asthma of to is able these assess be biomarker In clinical between will activity Phase RASP to metric, focus is no ADX-XXX of in

those profiles street understanding ADX-XXX readout general, specific certain trials. the point of cytokine this three at think, assessment have biomarker by X time in will kind the I the by affected other a of have of some very Phase But good We the to year.

Very helpful. Thank you.

a lot, Thanks Edwin.

Your from go next the ahead. Agrawal line JonesTrading. with question Please comes Prakhar of

and my questions. Hi. for thanks Good taking morning

the they be based Will for I mentioned mechanism indications also molecules be might enter think more Thank And Could compounds? new interest? year. of the of color these what some these on molecules, clinic that next give you you you. might on the RASP?

This excellent Aldeyra. Prakhar. future to of is Thanks. the transition an

as little is a I and part our behind progression. is on a pipeline. focus molecules, the many single of to develop focus One strategically We of to on see pipeline to of do core intend the series not strategies companies asset, new biotech a space certain assets very or with green initial is number large RASP ever is RASP of regarding almost to assets chemical a yes. and those new inhibitors. assets your about The These only. develop There compounds. are – of source us to Instead, answer available inhibition. we composition intend RASP compounds question to continue a

I'm As is freedom you compositional particularly seem believe and from to what considerable be what to RASP Many truly around of compounds. we reproxalap specific company et more about them metabolism, standpoint know, as we we to on and barrier foundational these operate. potent excited be have than focused blood-brain believe relate and PK, thus RASP inhibition, are developed solubility, they new advantages a ADX-XXX. only we RASP, Others formulation, penetration, a inhibition dosing the have cetera. have to structures

discover specific efforts molecules we've – but to RASP prioritize new not for only undergone new had we've So advancement. inhibitors,

And the As compound, year. compound retina be one a will those and/or we diseases. at systemic to being next least compounds I in clinic, targeted mentioned, with anticipate

Company. come & will Yale from Laidlaw question ahead. final of Please line the go Jen with Our

investors. scale Could the for Good if it first differences? a on each the was correctly, I current My prior provide color the trial the congrats, morning, I my is, progress. this is the for Todd. remember some you regarding four-point And -- INVIGORATE scale. question nine-point study That add, But study. come from

Yeah. to unit scale half The the Yale. with increments. It's scale is a because, it's semantics. a Good it's And of thanks morning, question. a matter for the scale. reason nine-point same just It's four, zero

X.X It's a It's thing. same et precisely and scale. nine-point X.X, about you you'll four-point So sometimes points. But and if you add get the scale. sometimes same cetera, talking up calls end, called zero and in the a nine scale include to we're four the

very Okay, of XXXX. design which That's study? you more the great. here, And endpoint, at is And you what what's study question the first the anticipate for is for helpful. maybe reiterate this Could part moment? the one

Right.

You're of Yale, speaking PVR?

Yes, yes.

detachment. of Retinal scarring retinal scarring, retina. And there surgeons retina, is compare months to retinal retinal GUARD is trial detachment Yes, injections. retinal those And then, rates And to over is The can two is that's But which care monitoring PVR. the leads sight. of to of therapy. two is One yes. ADX-XXXX PVR with loss essentially six that of behind standard detachment assess The the replace of intravitreal problem detachment designed rates is occurs, further issues. detachments.

next once has grows, six-month primary detachment we to pushed results reproxalap. proportion it's to back scar the The standard results this GUARD that, be visit used FDA those trial eye. patients retinal why year. course, And from the endpoint the trial the Because or next talk retinal a And that compare As we'll about to expect steps. again be a retina that's of FDA enrolled year. with in, the would expected with follow-up be off the is rates come agreed of care as can of in detachment

Maybe compared status? -- look one more sort of with study you're question here historical or which is, is placebo-controlled, the

either repair the care, standard of randomized or, standard of mentioned, that's And no standard is is are the one-to-one injections Patients is today, means to as treat monitoring. receive PVR. control ADX-XXXX care care. ADX-XXXX for care. The treatment, of today series to used The to not, of and of There other standard PVR. retina I than,

standard thus, of retinal care detachment the of So is and monitoring. repair essentially,

it Thanks great. appreciate I Okay, a lot. congrats. and

Yale. you, Thank Yeah.

back At this time, Brady any Todd closing to over call remarks. I'll turn Dr. the for

thank operator. Well, you,

the Annual Healthcare We events and eye OIS dry have a this showcase innovation including afternoon, Tuesday, at the next number up, Oppenheimer a coming presentation Conference. of virtual at

our progress. you you. forward And As with always, we on keeping updated look to connecting

call. Ladies that may you now conclude Thank disconnect. joining. And and you today's gentlemen, all will for