Earnings call transcript Q4 2022

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Aldeyra Therapeutics Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After speakers' presentations, there will be a question-and-answer session.

I would now like to hand the call over to -- the conference call over to Mr. Bruce Greenberg, the company's Interim Chief Financial Officer. Bruce Sir ahead, go Greenberg. Please

Bruce Greenberg

good Thank everyone. you, and morning,

Todd President and me today Executive our Dr. is With Chief Brady, Officer.

ended results This release morning, release section the is financial & the the www.aldeyra.com. of reporting press XXXX. year for Media recent corporate available copy we highlights and press issued of December XX, a our Investors at A on our website

future conference events this note morning's call Aldeyra. contains statements of that the and regarding future performance Please forward-looking

limited commercialization, to, trials, drug of potential and not expenses regarding timing statements FDA our possible our are Forward-looking opportunities. our our growth include, initiation of statements applications our operations, runway, and new or review but financial clinical of cash from results drug the assumed position, of projected of -- future applications, potential anticipated results

continuing different control including portions are and and statements current The our based concerning trials These to available and on to for regulatory information Aldeyra's subject or and candidates risks development, clinical on for trials based of us not clinical same They product the reflect today trials result analysis may the of or from clinical approaches. risks accurately is future uncertainties, quality plans or that future Aldeyra the are assumptions predict systems-based clinical review expectations of and events. results indications and views the data. and

events and our could Aldeyra assumes results forward-looking Future no obligation statements actual change. to update materially circumstances projected statements. from these differ those in as

in our the release this cause differ greater statements results described materially press to from information issued detail forward-looking Additional are in SEC. factors filings that our in morning and with could concerning our

the now call Brady. Dr. over to turn will I

Todd Brady

joining thank Good morning, Bruce. you, and you Thank for everyone, us.

The researchers for resulted and XXXX aggressive the companies me for year. FDA recently entire as ADX-XXXX, to which in and over and support this accepted We patients rare a as as any new to advance priorities by the have review eye begin a that are recognizing Reproxalap quarter FDA two few in dedication deeply have drug size potentially with retinal the strategic bring was designated with patients our disease priority approved and the invested who worked clinical past to us time applications, primary you've achieved investigators Aldeyra be and quickly actively cancer lymphoma, therapy. appreciate with well milestone your of Let team in possible. two new therapies no vitreoretinal achieving as high-grade working to dry proud

for to development Aldeyra's novel the in future. advancing inflammation. common validate They we've ADX-XXX, of And XXXX. rare drug engine. this our platform, These on catalysts foundation, ADX-XXX on and speak Building discovery we're diseases and platforms of focused NDAs strong the developed generation RASP by and the to are immune-mediated modulation they next power treat characterized both ADX-XXX

modulator many you those modulation. new many RASP platform use selectively instead all in protein, particular small modulate molecules target a a of is novel of today, directly simultaneously. Unlike that not activity proteins or activate to drugs almost the in pharmacologic designed but structure approach. and the family inhibit RASP platform are unique turn represent for thus represents and For systemic ocular disease, mediators targets Because therapeutic and that that are simultaneously, proteins are of in pro-inflammatory immune and affects elevated RASP inflammatory a to the Aldeyra,

skin. error inflammatory of X candidate, multiple and in a RAS change being of is dry, characterized trials ADX-XXX, degradation which that metabolism and a characterized recessive itchy is of syndrome, is by edema, nephrotic autosomal idiopathic Phase Sjogren-Larsson minimal clinical RASP; prevents specific group condition indications, chronic systemic by including renal evaluated proteinuria orally our an and disease, broad syndrome, dermatitis, modulator inflamed inborn product first-in-class atopic diseases, and hypoalbuminemia; administered hypersensitivity encompasses in that neurocutaneous including:

of a as nephrotic diseases Sjogren-Larsson The to atopic the a dermatitis designs are intended syndrome half and ADX-XXX Part X Top-line to trials activity demonstrate idiopathic expected results well that of as the develop from variety where in range syndrome clinical of RASP of trials clinical XXXX. across encompass are implicated. are second

unmet Our approximately clinical identify Toward unexplained establish chronic is patients a conducting is randomized, cough. and with to XX approach crossover to diseases, refractory clinical multiple relevance where significant. ADX-XXX common also rare we are in end, Phase this trial X strategic in opportunities of the both need or multi-center, the medical

We expect of to trial this top-line announce results year. half from in first the the

initiate to alcohol. decision role potential time, we We moderate options. support placebo-controlled hepatitis. placebo positive are of improved balance diseases, in ADX-XXX a plan in of results Phase December results acute believe test in X these the metabolite treating superior from alcohol-associated dermal there trial the to in clinical RASP the this reducing challenged lowering indication Additionally, modulation reported of in indication increasing in alcohol-associated and ADX-XXX a liver signs which stems treatment Phase The trial alcohol X acetaldehyde was following intoxication. few alcohol Romberg flushing, XXXX, pursue to an levels to which ethanol exposure RASP for we of

drug X adverse The XX administered and any not generally be XXX Phase has to been clinical patients in ADX-XXX days. has to trials events. serious been across to X approximately for has Phase resulted tolerated observed multiple well and up

treatment We by RASP the ADX-XXX ADX-XXX ADX-XXX. trial of geographic and second engine the and have strategically discovery invested thoughtfully development ADX-XXX of intravitreally treatment plan macular generation. of injected newest drug modulator to we half administered for and Phase form pipeline. atrophy, diseases of a our severe X/X product XXXX, for to initiate early XXXX systems-based immune-mediated In clinical are powered and candidates our or the of The systemic expand a orally

FDA ocular months the of last were the NDA vitreoretinal a for known June ingredient that review and The for we ADX-XXXX is accepted The of of methotrexate, primary safety regard The week, to lymphoma. NDA combination by acceptance to for supported designed thrilled efficacy ADX-XXXX, is priority of years the the also the date review. treatment a from our XXXX, PDUFA for NDA With with patients announce of of the submission four XX, lymphoma. further the lymphoma, FDA by data X on Phase treatment GUARD trial published than recently vitreoretinopathy. of of ocular active safety from the supported ADX-XXXX of XX in as completed more literature proliferative

ocular to in approved, lymphoma patients XXX United diagnosed is An median patients year, years. less estimated for each States newly If XXX survival five are the and than with the diagnosed year, make ADX-XXXX in drug in would for the States launch lymphoma. ADX-XXXX United of FDA patient approved the first expect to we the this from available ocular second suffering half which

rare vision. in diseases rare other cause condition of for the ADX-XXXX also by and loss development group proliferative of is retinal that surgery; completion and reattachment a vitreoretinopathy. plan development retinal C therapies: is of of genetic to of FDA of approved retinitis leading cell retinal clinical with a diseases a conduct eye for ADX-XXXX death failure the Type prevention of characterized vitreoretinopathy, two pigmentosa, mid-XXXX proliferative a We Meeting FDA to discuss the without

in plan of ADX-XXXX the from we report trial the patients pigmentosa X this clinical year. In retinitis and first with results addition, half of Phase top-line to

XX, is the PDUFA to XXXX. November date respect Reproxalap, With

preparing to internally. are partnering parties for engage commercialization in potential continue discussions multiple with for We also Reproxalap and

rapid of in to commercial onset and designed disease. preparations exploit trials eye clinical activity in dry patients unparalleled breadth the Our of observed Reproxalap are with

groups Last reported no treatment Reproxalap to week, deemed disease possibly treatment across trial clinical results of vehicle-controlled similar dry least the related and we identified. was Reproxalap safety vehicle-treatment and patients. top-line safety serious in XX-month events emergent adverse were for Ocular at

What demonstrated superior patients broad of estimate positive that we P-value acuity with action, acuity group a safety a to by the in onset that approximately Reproxalap observed and we trial billion differentiate acuity in activity what be further of the the treated Coupled visual Reproxalap $XX less XX%, believe vehicle. addressable the in landmark X.XXXX. in the potentially Visual is rapid statistically market about visual treated the resulting than in particularly in patients results U.S. was data potentially with to in significant Reproxalap is improved evidence with

Now, I'll turn back review. call financial to the Bruce the for over

Bruce Greenberg

Todd. Thanks,

ocular as liquidity we XXXX that on marketable the equivalents expenses XX, XXXX. ADX-XXXX, begin if with half second believe in and equivalents the This December and and me immune-mediated launch Let cash securities our early- candidates systemic $XXX.X current marketable of our plan, cash currently Based cash, our operating of diseases. development to into commercialization profile. million. operating Reproxalap existing and for were sufficient projected includes Cash, and continued securities late-stage of initial be approved, fund product will and plans and

for cost the $XX.X the per as net have and December XX, and XXXX expenses. was million clinical primarily of the $X.XX million period per trials or from development share for as compared the ended XXXX. general loss share in or our of administrative from programs resulted loss with Losses Net year same $X.XX research and well $XX.X

and million the ended in and expenses XXXX. which by This product increase same clinical drug expenditures, to million XX, decrease preclinical in with December external an a costs, personnel increase development were partially XXXX primarily development development costs. $XX.X period expenditures was were offset compared Research year for for manufacturing external the costs, $XX.X in related consulting

personnel to XXXX. costs. General were primarily ended million XX, This higher $XX.X and with in for administrative XXXX the period the expenditures compared was year and million consulting $XX.X expenses related higher for December same increase

Total the for ended in $XX.X of the year for compared period same with expenses $XX.X million expenses operating operating million were XXXX total XX, December XXXX.

turn Brady Now, Dr. remarks. the to back let for call me closing

Todd Brady

you, Thank Bruce.

clinical closer momentum milestones of goal across drug platforms year for immune-mediated applications. move for systemic key development new a in validation and to as diseases. was XXXX retinal continues the transformational highlighted XXXX regulatory including by achievement That our our and we two of the of drug Aldeyra, our submission of pipeline,

development and representing platform, modulation Reproxalap success from at path to RASP and ADX-XXX charting clinical which course drug new precisely clinic. and our designs industry, is poised science, our we're administered features own X one's Phase candidate created on candidates a Aldeyra. our varied two the foundation trials, for that strong now five The evidence enter In orally comes has of based the forging

Through drug rare for has and ADX-XXXX, creating proliferative which diseases without our indications orphan retinal retinitis we drug all for ocular therapies, first-line lymphoma, are pigmentosa, vitreoretinopathy FDA's therapy potential approved designation. received a beginning with FDA

questions. Operator? take be And happy we'll your with to that,

Operator

comes much. first today you [Operator question of go please Thank Securities. Instructions] SVB Marc Goodman Marc, very ahead. from Our

is open. line Your

Marc Goodman

how you the of profile broad effect excitement to oral. good spectrum And what's side the today? the that the oral? seen relative on that product market morning. a Hey, you've can is Todd, profile about you just think about talk Obviously, the and

you're profile far as profile? about side as be for sense thinking a the us give it? effect of just looking the Just how we should What -- Thanks.

Todd Brady

a other the And for highlighting pipeline. together Marc. Very to the say why would I modulation. lead toxicity. such and are thanks tends proteins had There's off to turned day. therein much fireside that of Thanks, RASP appreciated single have modulation inhibiting chat consistently we broadly There's reason our we they neither oral why also reason activating or or lies constitutively a turned on, RASP proteins. value

ADX-XXX, of all of that ADX-XXX, turn are family influence molecules proteins. a a mediators family that influence ADX-XXX in

lead RASP is to So, in and, Not to we dialing safety a activity, toxicity. do individually inflammation, value like, of The not from protein a should any where we're down of proteins drugs have we're knob have that master affecting only turning breadth that tolerability. therefore, less aren't we X but say, a on volume off. We to and or modulation, X.

that to date. We in observed have seen trials

effects. With ADX-XXX, few side very have we

we mentioned that I prepared have my to deemed have in As drug. events adverse no related serious comments, been

continue of other mechanism we will on in So, patients drug. as I profile test action the indications, based that to expect of continue the safety

Operator

Thank you.

from next ahead. Citigroup. Yigal, Yigal question Our is Nochomovitz go please from

Your line is open.

Yigal Nochomovitz

dry very filed. Hi. does and that's to approval? taking the you an extent to date [indiscernible] Could FDA has a Todd, for for eye, Reproxalap on the comment partnering with question. Thanks that the for respect target there, for PDUFA discussions obviously, much clear

that, Phase X to obviously, coming related you second AC up. the then for have And

necessary to want be determination about it dry file and that necessary second in eye think partners indicated I'm may that the make Thank AC to then are that? -- a thinking and just in you've it potentially patient that it'd given situation data I file you you. the to be indication? not extensive there, to populations. may overlap Is wondering between a where the as whether how past the necessarily see

Todd Brady

comment to comment happy Happy Yigal. conjunctivitis. to Thanks, discussions and on allergic partnering on

that relates FDA. the know, to at has FDA's Reproxalap of the thus, accepted you it disease to dry NDA review has for As extent, some regulatory and eye as been least been removed risk

As efficacy drug before, for and believe to that trials chronic three is different ever safety. said clinical disease a variety for acute weeks XX feature we've and now for we dry with and the most the of signs comprehensive a up submission NDA XX a administration months eye

All I think to to my Reproxalap that in differentiator. continue the the only visual Reproxalap that's And be in major work data drug is prepared I as ever administered quickly. over happen commercial development Also, as improvement that announced suggest in drug in all, demonstrate that something comments, chronic the appears acuity, can only to normally topically months. XX an we age doesn't a

would prior partnering mentioned are many would our interested potential negotiations, partners to my would timeframe. you that comments, to expect that Reproxalap can are and, expect do to across to tell in I I I in Reproxalap. involved be the case, October I terms. think multiple as label our September that of array are wide Therefore, occur in with there prepared partners I which, parties that a involved conversations want robust in

we Regarding disease a drug. conjunctivitis, to dry see allergic any that differentiator continue eye for indication major as

there's two can diseases. of simultaneously between it's And conjunctivitis. you for providers be distinguish a compound of that mentioned, disease those and difficult a allergic them healthcare Thus, considerable dry to or between should value. As considerable eye many drug treat both overlap

Yigal, at goal, in this is point, demonstrate of main the activity allergic Our conjunctivitis. to Reproxalap

INVIGORATE published with prepared which trial this year. one announced, of X II this trial, as one demonstrating across X We The I is Phase allergen of be different activity papers, conjunctivitis trial, Phase the my have two our chamber clinical of Reproxalap morning, trial, in in mentioned models. two second in of patients will allergic trial, first half comments

pending a conjunctivitis. Reproxalap a those for submit trials, results -- the application in decision we new pending to allergic think make with a I can the that And partnership the then of discussions about need drug Reproxalap,

Yigal Nochomovitz

Great. Thank you.

Todd Brady

Thanks, Yigal.

Operator

you. Thank

Co. Our next Justin comes question from Oppenheimer Kim & from

go Justin, ahead. please

is line open. Your

Justin Kim

about team. and regulatory of Hi, sort review for the sort With good the how commercialization these how on to morning, a of think year, congrats or questions wanted progress. the Todd the I Thanks in sort process commercialization assets, XXXX just taking for and progresses? to of for may think the and Reproxalap about and review how as over for locked you course differ of ask timeline they investment

Todd Brady

Good question. for the morning, Justin. Thanks

particularly segment launches well efforts sales though that in rare for are ADX-XXXX are particularly surgeons, As towards different. There are treat Reproxalap his is office, the Bruce back diseases we the that obviously mentioned prepared to in comments, targeted towards is launching both compounds. optometrists capitalized retinal compounds. those XXXX. for and for synergies, ophthalmology. certain anterior retinal targeted relate initial both The

limited there's breadth think and of treat I these number methotrexate of the regarding because: I we've treat two diseases. is reason at that marketing quite morning; the highlighted And that already activity a activity least the limited. physicians this using of A, and ADX-XXXX that say B, are diseases retinal is sales to physicians

in ocular United to States. there think something XX XX are the oncologists like I

to with consider designed And compounded se, that making injection the ADX-XX and is and of no to theory therefore, that more keratitis. which volume marketing methotrexate but the for typically is volume lower, is lower, aware compounding per sales you density methotrexate reduce that something higher, making that in all is ADX-XXXX aware clinically into effects be superior called side is access because really eye, I the a the punctate a longer physicians to is see the of injection physicians methotrexate don't effort, rather necessary market effort

was proliferative published the significantly GUARD compounded one with year the in adverse trial expect last the literature. than of a been lower least would result announced has what events X methotrexate we vitreoretinopathy, as of Phase as at keratitis As scientific in

there's all So, for with fact fact I'm those approved indications. the no that there's advantages about prospects the combined quite population thrilled of the with targetable commercial for the combined therapy the really ADX-XXXX drug reasons, a that of these physician

efforts commercialization. of internally pursuing Reproxalap, the is one initial we're For

internally. You prepared, is that to be a if launch that thorough process can necessary, will that, very expect we

always before. mass space, in market before, I've companies launch. it drugs, ocular it's We've with it feasible. many for As small But is said the times to certainly not seen optimal

I if deals unable to on we accessible. extent we're need do the to think right target that's to that that the secure partnering we're

Justin Kim

that maybe Great. just and Can then Okay. asset maybe of suited the earlier-stage XXX (ph) compared discuss thoughts And of tol? sort [SIMD for program. to sort on XXX? any indications the on RASP] you safety and just with differentiation Just better

Todd Brady

Right. candidates most to would effective we yet. product pharmacokinetic RASP RASP properties designed new modulators, direct the of is exhibit administered our modulator which platform, -- orally RASP a is select drug. really modulator ADX-XXX kinds an It or also is but our potent desire that for of for

There's know, is administered not once could potent has XXX dosage administered ADX-XXX, a XXX, potential administration to you only twice as more also profile. for the been daily. than XXX favorable be have it daily, more because

potent RASP patients specifically XXX dark trap, geographic AMD. is formulated and a intravitreal similar, atrophy this adaptation the will very for with but, in be also case, injection form in dry for of

Justin Kim

Thanks. Great.

Todd Brady

Thanks, Justin.

Operator

you. Thank

Our ahead. Kelly, go Kelly Shi is Jefferies. from next question from please

Your open. line is

Unidentified Analyst

questions. [Technical Difficulty] our

Todd, want are Any I systemic more specific on details color indications immune-mediated on give the you diseases? on XXX. follow-up So, the can pursuing? us to you

revenue I My plan includes XXXX confirm just want the of and both assets? both you. runway second XXXX second question Repro and is projected runway. launch on the the for Thank to to half that the

Todd Brady

to think question for your Thanks (ph). your relates for I about [Sean] indications XXX. question. And morning, Good XXX Justin's question

to that advantages of I ADX-XXX a being inherit The is dermatitis safety the Examples ADX-XXX expectation will is is today. trialed was X trial confirm highlighting might to there idea cough My question. or atopic some initiate include first. we'll alcohol-associated some chronic response pharmacokinetic indications where in ADX-XXX, or Justin's the that of clinical and Phase hepatitis.

the think we there activity that XXX, market to particularly to could from results need extent we consider then the is for trial and of mass the I the molecules indications. to some see ADX-XXX shifting

that orphan also remain ADX-XXX of equation. on will I'd the the expect side

two we orphan have one currently; know, syndrome. nephrotic you indications as being and is So, other syndrome are that idiopathic Sjogren-Larsson the tested is one

Bruce on in the fill feel Happy But comment and very to to cash, is as guidance briefly free clear. well.

I We ADX-XXXX. of That have launches. hope the next to given those year. both you Reproxalap answers sense cash have supports second approaching we're half a initial of And the commercialization how into for the cash prior questions and

Bruce Greenberg

Yeah. And would add just I that...

Unidentified Analyst

Thank you.

Bruce Greenberg

...forecast does include license expect a any is conservative revenue and does it any not arrangement. include nor from revenue --

Unidentified Analyst

Terrific. Thank you.

Todd Brady

you, Sean. Thank

Operator

you. Thank

Our is ahead. next question BTIG. from Shrader go Tom, Tom from please

Your line open. is

Unidentified Analyst

for Hey, on good (ph) morning. is This Tom. [Sung]

-- question. Just taking for thanks our

So, us. for two just

So, color pigmentosa? for provide ocular as ADX-XXXX, could indications recent additional for review the and PVRL you help how such may priority retinitis other on lymphoma

Is for to this And question, acuity moving strategy submit the second you so when will for safety data? the will something the be what you forward? visual Thanks. the data, best try include

Todd Brady

are Hi, morning. questions. Sung. superb Good Both of those

Our or is which methotrexate, NDA idea The regulatory care ADX-XXXX of reason the in where ADX-XXXX with treatment have bar first. aspects of that evaluated It's the strategy original submit the NDA After that safety get lower, to and an eyes ingredient lymphoma. is for is and been was is ocular lymphoma manufacturing of for is ocular of XXXX, intentional, -- controls XX the for that, standard NDA quite active safety NDAs, for already injected been because submission. submissions and in activity. somewhat acceptable years is so-called chemistry the supplemental subsequent

with a safety. compatible volume vitreous safety results all always the be the from we higher highlighted will GUARD standpoint and I so are X to and from particularly this also that why this important That's in safety. of in forth, not Those lymphoma density lymphoma in a vitreoretinopathy. with only and Phase new thrilled review. be the because part absolutely terms X proliferative case, a GUARD but have We a formulation of FDA safety submission, the assesses trial for assessed designed And lower results as morning were activity, Phase the the

methotrexate of which is based proliferative a terms But only than the makes have of by safety, literature. to it scientific sense for some was on and to to surgery. lymphoma methotrexate XXXX a In may actually anti-inflammatory not administer the activity associated also the submission administer because trauma large, with not but compound, be from compelling think XXXX, appeared safer and mitigate vitreoretinopathy, it on is we I the

was from safety particular. review, of in data will and trial that acuity XX-month unexpected acuity focuses the the update be visual remarkable the safety Reproxalap. NDA a the final trial in XX-month on data from XXX-day The of the safety visual safety data. highlighted part trial, There including safety as standard update, Obviously, quite is XX-month a which

of safety in What the the depends to negotiation I the also label, with actually think, the on we but up winds trial. intend FDA, publish results

think trials stand dry I comments, our visual the should I are quite to to mentioned dry And relative safety acuity as in eye prepared remarkable. space. in from results disease, potential in other competition XX-month my the differentiate Reproxalap

Unidentified Analyst

you. Great. Thank

Todd Brady

Sung. Thanks,

Operator

Thank you.

Our go next Research. question Catherine, ahead. Catherine Jones is from from Novack please

open. is line Your

Catherine Novack

for taking Thanks question. Hi, good morning. my

wanted you treatment is the Just the what clinically question. acuity the in study? [indiscernible] of this visual in extend how kind change in And for group? Can last group XX% safety was significant vehicle to the improvement the in -- on

Todd Brady

baseline. improvement that Reproxalap arm, the The greater and Both Catherine. the Good significantly drug vision than arm, drug morning, in from of improved vehicle vehicle. statistically was

a affects phenomena. edema One that There speaks couple cornea, are think in is is dry visual or eye to acuity. of swelling inflamed. which patients I the

with expect either we to these drug, we're vehicle or As patients improve. inflammation treating that would

our drug and Reproxalap activity visual improve What's in an remarkable in trials plus shown you case, can it's the either acuity. or that vehicle dry improvement the eye to go calming other down that in the visual facilitates is inflammation drug reducing disease, the back if improving in that is, improvement again, never the this broadly to itself, visual of that And drug edema been XX-month potentially I acuity. vehicle, speaks product acuity and think of safety

normal acuity. patients XXXX, I if In enrollment, than acuity, XXXX these more it's or best have worse Catherine, corrected enrolled of have other they design, patients, not Most obvious think, than for are by visual reasons. words, in

see that in improvement So, quite any essentially I change, are it's in any group of remarkable. a to patients visual think normal, acuity

I in acuity disease, to that group as particularly worsen XXs. see response over age expect slightly, months, characteristic you is is, mentioned to in dry we on which average, As of age would in XX question, visual another the your

all in visually frankly, these It's quite So, ocular here, that's disease not all, findings I you to something think, than of little see are populations. massively think any speaks in I the activity would with improvement, impaired remarkable. But relevant and, clinically there's the acuity. more drug

to We little see, we think have drug. of the that for bit if speaks a eyeballs see and better, I activity volumes

Catherine Novack

question. you. Got complement last very cetera, for That's AMD, point, oxidative you RASP the have inflammation, the cascade. I'm know if one And that can atrophy. geographic talk but the on therapeutic et We of it. rationale helpful. stress, in have wondering about been focused approaches modulators implicated Thank then, this at most

differentiating your initiation of is what the led you about what study? to the And approach? So, do think

Todd Brady

different. Well, talk it about to We're modulation. be I modulation are treat atrophy backwards a to in from time, that cascade. disease dry about somewhat could we RASP geographic entirely as broadly is this look relates by we aspect RASP a targeting for AMD single embarrassed an and excited that inflammatory It the of hour. now tried could complement particularly decades complicated and one

modulation inflammation that's of of way, RAS variety in idea another how a single geographic broadly excited exactly They said reduce to mentioned They proteins from affect one a aspect complement of influence comments, why just proteins, many fronts modulation behave. we're broad are atrophy. I about the different not As pro-inflammatory. of cascade. simultaneously, group and, is of and my RASP prepared RASP a different in That's the part in

called Part macromolecules These disease dry RASP. directly a accumulation in metabolites eye. which derived of the compounds compound the are are characteristic comprised GA from are such back of drusen, which is group of as diseases build and that of AMD two the so-called or is related of up or undigestible lipofuscin, and the Stargardt

these is the So, rid RASP also happens getting retina metabolites accumulation of not accumulation but are to lead to of indigestible And time pro-inflammatory in only lipofuscin of and what over which of. capable not GA, the is drusen. they macromolecules, that lead this

have the buildup broad think, mechanisms related formation inflammation, we of of I eye as Stargardt with of age. the and these in also back MD dry anti-inflammatory and and the the two that RASP GA modulation, very but approach, a it's metabolites clear So, we that prevention are

Catherine Novack

Got it. my you Thank so questions. taking much for

Todd Brady

My pleasure, Catherine.

Operator

Thank you.

now will question Jen last our from ahead. from go please Company. We Yale Yale, take & Laidlaw

Your line is open.

Yale Jen

thanks Good questions. and for taking morning, the

INVIGORATE-X could give current terms you update data this report when a In little the the the study, of and others? what's study enrollment will a patient but status of that you And terms -- then, half, us bit and in of started the have I Thanks. follow-up.

Todd Brady

your all Aldeyra It's just an years. earnings for didn't the I Yale. you absolute been wouldn't if support thank be pleasure. over It an Thanks, call,

the patients are years think, is air. cannot there's And two we almost you allergen not may of that in and there's compounds allergen the the ambient I INVIGORATE-X, because reason pollen you may chamber, the when during allergen chamber trials ago. winter. for thus most ambient started these run I treat pollen, chamber in say When activity trials, pollen that observe or the

So, we last had winter year's season.

We season. spring pollen early this guiding INVIGORATE-X year's next arrive the why two. half that or again we're will in have winter is The for reason this month

able longer will enrollment be complete expect be soon. enroll patients would will We and relatively we no thus to

is a itching ocular really endpoint, only X FDA in approved endpoint, itching, the reminder, scale, a primary is that As patient typically to reported the allergy X.

to chamber the confirm As performed INVIGORATE allergen those many clinical itching Phase relative relevance the We you X chamber INVIGORATE-X. findings. know, across the hope significantly the was see trial, to reduced in allergen Phase trial, X across thing trial, across our and to we've same ALLEVIATE the analyses of vehicle,

know, trials data for allergic efficacy would assuming conjunctivitis. we INVIGORATE-X, as our conclude positive far As INVIGORATE-X

Yale Jen

more great. from that report for data we XXXX very you Maybe should one it? anticipate pigmentosa What once helpful. here, Okay, data readout. That's which is with retinitis

Todd Brady

We half. about three talked of each for a pigmentosa. retinitis I I've pigmentosa to of highlighting just half. those There retinitis the of think two, then, that third milestones INVIGORATE-X. each highlights milestones What for pipeline, our are I previously. thanks like three and is this of is we milestone discussed being our remarkable expect and think major three cough chronic third. oral of is this in our the different milestones aspects Reproxalap the Aldeyra in being Well, company business And about are being business. representative aspect one, parts, ADX-XXXX those

It testing might vitreoretinopathy To interesting. patients ADX-XXXX. that with X,XXX is patients incident be patients pigmentosa currently methotrexate roughly think appear to particularly sensitive administration. retinitis particular with incident incident the XX,XXX pick Retinitis that to to mutations of we're proliferative lymphoma, is round pigmentosa with largest three like the indications numbers, something and with of the one relate XXX

basis pigmentosa. at of our staff of series many ADX-XXXX in the of certainly pigmentosa was and using pigmentosa, many deck. about retinitis in patients Aldeyra The in and And potential and experiments, is retinitis remarkable here are spanning methotrexate for ADX-XXXX molecules thousands models clinical It's in winner excited investigators thus, a for cited animal the been methotrexate. the retinitis

to as been patients. This open I this to administered methotrexate an results is able mentioned, pigmentosa retinitis expect first be And to trial. has is would announce half. label time we, the This

Yale Jen

helpful. And very all this Okay, That's great. year. for these of congrats again, catalysts

Todd Brady

time, Exciting Yale. you. Thank

Operator

call Thank you. the for back to turn I'll closing Brady Dr. now comments.

Todd Brady

morning. this us joining for you Thank

bringing we forward novel need. with our an as exciting And medical to We look significant XXXX. therapies for are in to unmet year positioned patients always,

Operator

Thank today's joining for call. everyone you

your and a lovely disconnect may have You day. now lines,

Aldeyra Therapeutics (ALDX) 9 Mar 232022 Q4 Earnings call transcript